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Table of Contents
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As filed with the Securities and Exchange Commission on December 15, 2023
Registration No. 333-          
 
 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
 
Form
S-4
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
 
 
Homology Medicines, Inc.
(Exact name of registrant as specified in its charter)
 
 
 
Delaware
 
2834
 
47-3468154
(State or other jurisdiction of
incorporation or organization)
 
(Primary Standard Industrial
Classification Code Number)
 
(I.R.S. Employer
Identification Number)
One Patriots Park
Bedford, MA 01730
(781)
327-2633
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
 
 
Paul Alloway, Ph.D.
President and Chief Operating Officer
One Patriots Park
Bedford, MA 01730
(781)
327-2633
(Name, address, including zip code, and telephone number, including area code, of agent for service)
 
 
Copies to:

 
Peter N. Handrinos
Leah R. Sauter
Elisabeth M. Martin
Latham & Watkins LLP
200 Clarendon Street
Boston, MA 02116
(617)
948-6000
 
Jodie Morrison
President and Chief Executive Officer
Q32 Bio Inc.
830 Winter Street
Waltham, MA 02451
(781)
999-0232
 
Kingsley L. Taft
Sarah Ashfaq
John Haggerty
Jacqueline Mercier
Goodwin Procter LLP
100 Northern Avenue
Boston, MA 02210
(617)
570-1000
 

Approximate date of commencement of proposed sale of the securities to the public:
As soon as practicable after the effective date of this registration statement and the satisfaction or waiver of all other conditions under the Merger Agreement described herein.
If the securities being registered on this Form are being offered in connection with the formation of a holding company and there is compliance with General Instruction G, check the following box:  ☐
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐
If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated
filer, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule
12b-2
of the Exchange Act.
 
Large accelerated filer   ☐    Accelerated filer   ☐
       
Non-accelerated filer   ☒    Smaller reporting company   ☒
       
         Emerging growth company   ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act.  
☐
If applicable, place an X in the box to designate the appropriate rule provision relied upon in conducting this transaction:
Exchange Act Rule
13e-4(i)
(Cross-Border Issuer Tender Offer)  ☐
Exchange Act Rule
14d-1(d)
(Cross-Border Third-Party Tender Offer)  ☐
 
 
The Registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
 
 
 


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The information in this proxy statement/prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This proxy statement/prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

 

SUBJECT TO COMPLETION, DATED DECEMBER 15, 2023

 

LOGO    LOGO

PROPOSED MERGER

YOUR VOTE IS VERY IMPORTANT

 

 

To the Stockholders of Homology Medicines, Inc. and Q32 Bio Inc.,

Homology Medicines, Inc., a Delaware corporation, or Homology, and Q32 Bio Inc., a Delaware corporation, or Q32, entered into an Agreement and Plan of Merger, or the Merger Agreement, on November 16, 2023, pursuant to which a direct, wholly owned subsidiary of Homology, Kenobi Merger Sub, Inc., or Merger Sub, will merge with and into Q32, with Q32 surviving as a direct, wholly owned subsidiary of Homology, and the surviving corporation of the merger, which transaction is referred to herein as the Merger. Homology following the Merger is also referred to herein as the combined company.

At the time the certificate of merger is filed with and accepted by the Secretary of State of the State of Delaware, or the Effective Time, as described in more detail in the section titled “The Merger—Effective Time of the Merger” beginning on page 182 of the accompanying proxy statement/prospectus, each share of Q32 common stock (after giving effect to the conversion of each share of Q32’s preferred stock into Q32 common stock and the conversion of Q32’s convertible notes into Q32 common stock and including all such shares that are converted into Q32 common stock) will be converted into the right to receive a number of shares of Homology common stock equal to the total number of shares of Homology common stock to be issued in the Merger multiplied by the applicable Q32 stockholder’s percentage interest in Q32 as set forth in the allocation certificate to be provided by Q32, or the Allocation Certificate, and as described in more detail in the section titled “The Merger Agreement—Allocation Certificate” beginning on page 188 of the accompanying proxy statement/prospectus. The Q32 common stock that will be converted in connection with the Merger includes Q32 common stock to be issued pursuant to the subscription agreement by and among Q32 and certain parties to purchase an aggregate of $42.0 million of shares of Q32’s common stock, which transaction is referred to as the Pre-Closing Financing. If any Q32 common stock outstanding immediately prior to the Effective Time is unvested or is subject to a repurchase option or a risk of forfeiture under any applicable agreement with Q32, then the shares of Homology common stock issued in exchange for such shares of Q32 common stock will to the same extent be unvested and subject to the same repurchase option or risk of forfeiture, and such shares of Homology common stock will be marked with appropriate legends.

In connection with the Merger, each option to purchase shares of Q32 common stock outstanding as of immediately prior to the Effective Time will be assumed by Homology and converted, at the Effective Time, into an option to acquire the number of shares of Homology common stock equal to the number of shares of Q32 common stock subject to such option as of immediately prior to the Effective Time multiplied by the exchange ratio formula in the Merger Agreement and rounding that result down to the nearest whole number of shares, at a per share exercise price equal to the per share exercise price of such option immediately prior to the Effective Time multiplied by the exchange ratio formula in the Merger Agreement, rounded up to the nearest whole cent, and each unexercised warrant to purchase shares of Q32 common stock outstanding immediately prior to the Effective Time will be assumed by Homology and converted into a warrant to purchase shares of Homology’s common stock, with adjustments to the number of shares and the exercise price to reflect the exchange ratio formula in the Merger Agreement.

Each share of Homology common stock that is issued and outstanding at the Effective Time will remain issued and outstanding and such shares will be unaffected by the Merger but will be subject to a proposed reverse stock split of Homology’s issued and outstanding common stock at a ratio ranging from any whole number between 1-for-                 and 1-for-                 as determined by the Homology board of directors in its discretion, or the Reverse Stock Split, as described in the section titled “Matters Being Submitted to a Vote of Homology Stockholders—Proposal No. 3: Approval of the Amendment to the Restated Certificate of Incorporation of


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Homology Effecting the Reverse Stock Split” beginning on page 233 of the accompanying proxy statement/prospectus. Each outstanding option to purchase shares of Homology common stock that has an exercise price per share that is less than the closing trading price of a share of Homology common stock on the last full trading date on which the Homology common stock is traded prior to the date on which the Effective Time occurs, which is referred to as a Homology ITM Option, will vest in full immediately prior to the Effective Time and remain outstanding, subject to proportionate adjustment in accordance with the terms of Homology’s 2018 Incentive Award Plan or 2015 Stock Incentive Plan, as applicable, to reflect the Reverse Stock Split and the issuance of the contingent value rights, or CVRs. Each outstanding option to purchase shares of Homology common stock that is not a Homology ITM Option will be cancelled for no consideration immediately prior to the Effective Time. Each restricted stock unit award covering shares of Homology common stock, which is referred to as a Homology Restricted Stock Unit, that is outstanding will vest in full immediately prior to the Effective Time, and the holder of each unsettled Homology Restricted Stock Unit will receive immediately prior to the Effective Time, the number of shares of Homology common stock equal to the number of vested and unsettled shares of Homology common stock underlying such Homology Restricted Stock Unit.

Immediately after the Merger, Homology securityholders as of immediately prior to the Merger are expected to own approximately 25% of the outstanding shares of the combined company on a fully-diluted basis and former Q32 securityholders (including purchasers in the Pre-Closing Financing) are expected to own approximately 75% of the outstanding shares of the combined company on a fully-diluted basis, subject to certain assumptions, including, but not limited to, Homology’s net cash as of closing being equal to $60.0 million and Q32 issuing approximately $42.0 million of Q32 common stock in the Pre-Closing Financing described elsewhere in this proxy statement/prospectus. Under certain circumstances further described in the Merger Agreement, the ownership percentages may be adjusted up or down including, but not limited to, if Homology’s net cash as of closing is lower than $59.5 million or greater than $60.5 million.

Shares of Homology common stock are currently listed on The Nasdaq Global Select Market, or Nasdaq, under the symbol “FIXX.” Q32 intends to file an initial listing application for the combined company with the Nasdaq Stock Market LLC. After completion of the Merger, Homology will be renamed “Q32 Bio Inc.” and it is expected that the common stock of the combined company will trade on Nasdaq under the symbol “QTTB.” On                 , 2024, the last trading day before the date of the accompanying proxy statement/prospectus, the closing sale price of Homology common stock was $                 per share.

Homology stockholders are cordially invited to attend the special meeting of Homology stockholders, or the Homology Special Meeting. Homology is holding the Homology Special Meeting, on                 , 2024, at                  Eastern Time, unless postponed or adjourned to a later date, in order to obtain the stockholder approvals necessary to complete the Merger. The Homology Special Meeting will be held entirely online. Homology stockholders will be able to attend and participate in the Homology Special Meeting online by visiting                  where they will be able to listen to the meeting live, submit questions and vote. At the Homology Special Meeting, Homology will ask its stockholders:

 

  1.

To approve the issuance of shares of common stock of Homology to stockholders of Q32 pursuant to the terms of the Agreement and Plan of Merger, dated as of November 16, 2023, by and among Homology, Merger Sub, and Q32, a copy of which is attached as Annex A to the accompanying proxy statement/prospectus, pursuant to which Merger Sub will merge with and into Q32, with Q32 surviving as a wholly owned subsidiary of Homology, and the surviving corporation of the merger and the change of control resulting from the merger, or the Stock Issuance Proposal;

 

  2.

To approve an amendment to the Restated Certificate of Incorporation of Homology, a copy of which is attached as Annex G to the accompanying proxy statement/prospectus, to increase the number of authorized shares of Homology common stock to 400,000,000, subject to the Homology board of directors’ authority to abandon such amendment, or the Authorized Share Increase Proposal;

 

  3.

To approve an amendment to the Restated Certificate of Incorporation of Homology, a copy of which is attached as Annex G to the accompanying proxy statement/prospectus, to effect a reverse stock split of Homology’s issued and outstanding common stock at a ratio ranging from any whole number


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  between 1-for-                and 1-for-                , as determined by the Homology board of directors in its discretion, subject to the Homology board of directors’ authority to abandon such amendment, or the Reverse Stock Split Proposal;

 

  4.

To approve the 2024 Stock Option and Incentive Plan, a copy of which is attached as Annex I to the accompanying proxy statement/prospectus, or the Stock Option and Incentive Plan Proposal;

 

  5.

To approve the 2024 Employee Stock Purchase Plan, a copy of which is attached as Annex J to the accompanying proxy statement/prospectus, or the ESPP Proposal; and

 

  6.

To consider and vote upon an adjournment of the Homology Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of the Stock Issuance Proposal, the Authorized Share Increase Proposal and the Reverse Stock Split Proposal, or the Adjournment Proposal.

As described in the accompanying proxy statement/prospectus, certain Homology stockholders who in the aggregate owned approximately 18.3% of the outstanding shares of Homology as of November 30, 2023, and certain Q32 stockholders who in the aggregate owned approximately 74.1% of the outstanding shares of Q32 common stock and Q32 preferred stock as of October 31, 2023, are parties to stockholder support agreements with Homology and Q32, respectively, whereby such stockholders have agreed to vote in favor of the approval of the transactions contemplated therein, including, with respect to such Q32 stockholders, adoption of the Merger Agreement and approval of the Merger and, with respect to such Homology stockholders, the issuance of Homology common stock in the Merger pursuant to the Merger Agreement, subject to the terms of the support agreements. Following the effectiveness of the registration statement on Form S-4 of which the accompanying proxy statement/prospectus is a part and pursuant to the Merger Agreement, Q32 stockholders holding a sufficient number of shares of Q32 common stock to adopt the Merger Agreement and approve the Merger and related transactions will be asked to execute written consents providing for such adoption and approval.

After careful consideration, each of the Homology and Q32 boards of directors have approved the Merger Agreement and have determined that it is advisable to consummate the Merger. The Homology board of directors has approved the proposals described in the accompanying proxy statement/prospectus and unanimously recommends that its stockholders vote “FOR” each of the proposals described in the accompanying proxy statement/prospectus.

 

 

More information about Homology, Q32, the Merger Agreement and transactions contemplated thereby and the foregoing proposals is contained in the accompanying proxy statement/prospectus. Homology urges you to read the accompanying proxy statement/prospectus carefully and in its entirety. IN PARTICULAR, YOU SHOULD CAREFULLY CONSIDER THE MATTERS DISCUSSED UNDER “RISK FACTORS” BEGINNING ON PAGE 29 OF THE ACCOMPANYING PROXY STATEMENT/PROSPECTUS.

Homology and Q32 are excited about the opportunities the Merger brings to Homology’s and Q32’s stockholders and thank you for your consideration and continued support.

Sincerely,

 

Paul Alloway, Ph.D.

President and Chief Operating Officer

Homology Medicines, Inc.

  

Jodie Morrison

President and Chief Executive Officer

Q32 Bio Inc.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of the accompanying proxy statement/prospectus. Any representation to the contrary is a criminal offense.

The accompanying proxy statement/prospectus is dated                      and is first being mailed to Homology stockholders on or about                  .


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HOMOLOGY MEDICINES, INC.

ONE PATRIOTS PARK

BEDFORD, MA 01730

(781) 327-2633

NOTICE OF SPECIAL MEETING OF STOCKHOLDERS

To the stockholders of Homology Medicines, Inc., or Homology:

NOTICE IS HEREBY GIVEN that a special meeting of stockholders of Homology, or the Homology Special Meeting, will be held on                 , 2024, at                 Eastern Time, unless postponed or adjourned to a later date. The Homology Special Meeting will be held entirely online. You will be able to attend and participate in the Homology Special Meeting online by visiting                  where you will be able to listen to the Homology Special Meeting live, submit questions and vote.

The Homology Special Meeting will be held for the following purposes:

 

  1.

To approve the issuance of shares of common stock of Homology to stockholders of Q32 Bio Inc., or Q32, pursuant to the terms of the Agreement and Plan of Merger, dated as of November 16, 2023, by and among Homology, Kenobi Merger Sub, Inc., a direct, wholly owned subsidiary of Homology, or Merger Sub, and Q32, a copy of which is attached as Annex A to the accompanying proxy statement/prospectus, pursuant to which Merger Sub will merge with and into Q32, with Q32 surviving as a wholly owned subsidiary of Homology, and the surviving corporation of the merger, or the Merger, and the change of control resulting from the Merger, or the Stock Issuance Proposal;

 

  2.

To approve an amendment to the Restated Certificate of Incorporation of Homology, a copy of which is attached as Annex G to the accompanying proxy statement/prospectus, to increase the number of authorized shares of Homology common stock to 400,000,000, subject to the Homology board of directors’ authority to abandon such amendment, or the Authorized Share Increase Proposal;

 

  3.

To approve an amendment to the Restated Certificate of Incorporation of Homology, a copy of which is attached as Annex G to the accompanying proxy statement/prospectus, to effect a reverse stock split of Homology’s issued and outstanding common stock at a ratio ranging from any whole number between 1-for-                and 1-for-                , as determined by the Homology board of directors in its discretion subject to the Homology board of directors’ authority to abandon such amendment, or the Reverse Stock Split Proposal;

 

  4.

To approve the 2024 Stock Option and Incentive Plan, a copy of which is attached as Annex I to the accompanying proxy statement/prospectus, or the Stock Option and Incentive Plan Proposal;

 

  5.

To approve the 2024 Employee Stock Purchase Plan, a copy of which is attached as Annex J to the accompanying proxy statement/prospectus, or the ESPP Proposal; and

 

  6.

To consider and vote upon an adjournment of the Homology Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of the Stock issuance Proposal, the Authorized Share Increase Proposal and the Reverse Stock Split Proposal, or the Adjournment Proposal.

Record Date:    Homology’s board of directors has fixed                 as the record date for the determination of stockholders entitled to notice of, and to vote at, the Homology Special Meeting and any adjournment or postponement thereof. Only holders of record of shares of Homology common stock at the close of business on the record date are entitled to notice of, and to vote at, the Homology Special Meeting. At the close of business on the record date, Homology had                  shares of common stock outstanding and entitled to vote.

Your vote is important. The affirmative vote of the holders of a majority in voting power of the votes cast affirmatively or negatively at the Homology Special Meeting by the holders entitled to vote thereon is required for approval of the Stock Issuance Proposal, the Authorized Share Increase Proposal, the


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Reverse Stock Split Proposal, the Stock Option and Incentive Plan Proposal, the ESPP Proposal and the Adjournment Proposal. Approval of the Stock Issuance Proposal, the Authorized Share Increase Proposal and the Reverse Stock Split Proposal is a condition to the completion of the Merger. Therefore, the Merger cannot be consummated without the approval of the Stock Issuance Proposal, the Authorized Share Increase Proposal and the Reverse Stock Split Proposal.

Even if you plan to attend the Homology Special Meeting, Homology requests that you sign, date and promptly return the enclosed proxy card or vote by telephone or online to ensure that your shares will be represented at the Homology Special Meeting. You may change or revoke your proxy at any time before it is voted at the Homology Special Meeting.

HOMOLOGY’S BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES THAT EACH OF THE PROPOSALS OUTLINED ABOVE IS FAIR TO, IN THE BEST INTERESTS OF, AND ADVISABLE TO HOMOLOGY AND ITS STOCKHOLDERS AND HAS APPROVED EACH SUCH PROPOSAL. HOMOLOGY’S BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS THAT HOMOLOGY STOCKHOLDERS VOTE “FOR” EACH SUCH PROPOSAL.

By Order of Homology’s Board of Directors,

Paul Alloway, Ph.D.

President and Chief Operating Officer

Bedford, MA

            ,


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ADDITIONAL INFORMATION

This proxy statement/prospectus incorporates important business and financial information about Homology Medicines, Inc. that is not included in or delivered with this document. You may obtain this information without charge through the Securities and Exchange Commission website (www.sec.gov).

If you would like to request documents from Homology or Q32, please send a request in writing or by telephone to either Homology or Q32 at the following addresses:

 

Homology Medicines, Inc.

One Patriots Park

Bedford, MA 01730

(781) 327-2633

Attn: Corporate Secretary

Email: IR@homologymedicines.com

  

Q32 Bio Inc.

830 Winter Street

Waltham, MA 02451

Attn: Investor Relations

(781) 999-0232

Email: IR@q32bio.com

If you are a Homology stockholder and would like additional copies, without charge, of this proxy statement/prospectus or if you have questions about the Merger, including the procedures for voting your shares, you should contact Homology’s proxy solicitor, Morrow Sodali LLC, or Morrow Sodali, at the following address and telephone number:

Morrow Sodali LLC

430 Park Avenue, 14th Floor

New York, NY 10022

Banks and Brokers Call: (203) 658-9400

Stockholders Call Toll Free: (800) 662-5200

To ensure timely delivery of these documents, any request should be made no later than                 , to receive them before the Homology Special Meeting.

For additional details about where you can find information about Homology, please see the section titled “Where You Can Find More Information” beginning on page 450 of this proxy statement/prospectus.


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ABOUT THIS PROXY STATEMENT/PROSPECTUS

This document, which forms part of a registration statement on Form S-4 filed with the U.S. Securities and Exchange Commission, or the SEC, by Homology Medicines, Inc., or Homology, constitutes a prospectus of Homology under the Securities Act of 1933, as amended, or the Securities Act, with respect to the shares of common stock of Homology to be issued (or reserved for issuance) to the securityholders of Q32 Bio Inc., or Q32, pursuant to the Agreement and Plan of Merger, dated as of November 16, 2023, by and among Homology, Kenobi Merger Sub, Inc., a direct, wholly owned subsidiary of Homology, or Merger Sub, and Q32, as it may be amended from time to time, or the Merger Agreement, pursuant to which Merger Sub will merge with and into Q32, with Q32 surviving as a wholly owned subsidiary of Homology, and the surviving corporation of the merger, or the Merger. This document also constitutes a proxy statement of Homology under Section 14(a) of the Securities Exchange Act of 1934, as amended, or the Exchange Act. It also constitutes a notice of meeting with respect to the special meeting of Homology stockholders, or the Homology Special Meeting, at which Homology stockholders will be asked to consider and vote, among other matters, on the issuance of the shares of Homology common stock pursuant to the Merger Agreement and the change of control resulting from the Merger. Homology following the Merger is referred to in this proxy statement/prospectus as the combined company.

Homology has supplied all information contained in this proxy statement/prospectus relating to Homology. Q32 has supplied all information contained in this proxy statement/prospectus relating to Q32.

You should rely only on the information contained in this proxy statement/prospectus. Homology and Q32 have not authorized anyone to provide you with information that is different from that contained in this proxy statement/prospectus. This proxy statement/prospectus is dated                 , 2024, and you should not assume that the information contained in this proxy statement/prospectus is accurate as of any date other than such date. Neither the mailing of this proxy statement/prospectus to Homology stockholders nor the issuance by Homology of shares of Homology common stock pursuant to the Merger Agreement will create any implication to the contrary.

Except where otherwise noted, the information contained in this proxy statement/prospectus does not give effect to the proposed reverse stock split of Homology’s issued and outstanding common stock at a ratio ranging from any whole number between 1-for-                 and 1-for-                 as determined by the Homology board of directors in its discretion, or the Reverse Stock Split, described in the section titled “Matters Being Submitted to a Vote of Homology Stockholders—Proposal No. 3: Approval of the Amendment to the Restated Certificate of Incorporation of Homology Effecting the Reverse Stock Split” beginning on page 233 of this proxy statement/prospectus.

Homology and Q32 have proprietary rights to trademarks, trade names and service marks appearing in this proxy statement/prospectus that are important to their respective businesses. Solely for convenience, the trademarks, trade names and service marks may appear in this proxy statement/prospectus without the ® and TM symbols, but any such references are not intended to indicate, in any way, that Homology or Q32 forgo or will not assert, to the fullest extent under applicable law, their rights or the rights of the applicable licensors to these trademarks, trade names and service marks. All trademarks, trade names and service marks appearing in this proxy statement/prospectus are the property of their respective owners.


Table of Contents

TABLE OF CONTENTS

 

CAUTIONARY STATEMENT CONCERNING FORWARD-LOOKING STATEMENTS

     1  

QUESTIONS AND ANSWERS

     2  
          

Questions and Answers About the Merger

     2  
 

Questions and Answers About the Homology Special Meeting and Voting

     7  
PROSPECTUS SUMMARY      13  
 

The Companies

     13  
 

The Merger (See page 153)

     15  
 

Reasons for the Merger (See pages 161 and 164)

     16  
 

Opinion of Homology’s Financial Advisor (See page 166)

     17  
 

Interests of Certain Directors and Executive Officers of Homology and Q32 (See pages 174 and 180)

     18  
 

Overview of the Merger Agreement and Agreements Related to the Merger Agreement

     19  
 

Management Following the Merger (See page 388)

     24  
 

Material U.S. Federal Income Tax Consequences of the Merger (See page 220)

     24  
 

Nasdaq Stock Market Listing (See page 183)

     25  
 

Anticipated Accounting Treatment (See page 183)

     25  
 

Appraisal Rights and Dissenters’ Rights (See page 183)

     25  
 

Comparison of Stockholder Rights (See page 430)

     25  
 

Risk Factors (See page 29)

     26  

MARKET PRICE AND DIVIDEND INFORMATION

     28  
 

Dividends

     28  

RISK FACTORS

     29  
 

Risks Related to the Merger

     29  
 

Risks Related to the Proposed Reverse Stock Split

     33  
 

Risks Related to the Combined Company

     34  
 

Risks Related to Homology’s Business

     44  
 

Risks Related to Q32’s Business

     104  

THE MERGER

     153  
 

Background of the Merger

     153  
 

Homology Reasons for the Merger

     161  
 

Q32 Reasons for the Merger

     164  
 

Opinion of Homology’s Financial Advisor

     166  
 

Certain Unaudited Financial Projections for Q32

     171  
 

Interests of Homology Directors and Executive Officers in the Merger

     174  
 

Interests of Q32 Directors and Executive Officers in the Merger

     180  
 

Effective Time of the Merger

     182  
 

Regulatory Approvals

     183  
 

Anticipated Accounting Treatment

     183  
 

Nasdaq Stock Market Listing

     183  
          

Appraisal Rights and Dissenters’ Rights

     183  

THE MERGER AGREEMENT

     187  
 

Structure

     187  
 

Completion and Effectiveness of the Merger

     187  

 

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Merger Consideration

     187  
 

Allocation Certificate

     188  
 

Q32 Merger Shares

     188  
 

Pre-Closing Financing Merger Shares

     189  
 

Calculation of Homology’s Net Cash

     189  
 

Treatment of Q32 Options

     191  
 

Treatment of Q32 Warrants

     191  
 

Treatment of Homology Common Stock, Homology Options and Homology Restricted Stock Units

     191  
 

Homology Employee Stock Purchase Plan

     192  
          

Procedures for Exchanging Q32 Stock Certificates

     192  
 

Directors and Officers of Homology Following the Merger

     192  
 

Amendment of the Restated Certificate of Incorporation of Homology

     193  
 

Potential Asset Sale

     193  
 

Representations and Warranties

     193  
 

Covenants; Conduct of Business Pending the Merger

     194  
 

Contingent Value Rights

     197  
 

Non-Solicitation

     198  
 

Board Recommendation Change

     200  
 

Meeting of Homology’s Stockholders and Written Consent of Q32’s Stockholders

     201  
 

Regulatory Approvals

     202  
 

Indemnification and Insurance for Directors and Officers

     202  
 

Section 16 Matters

     203  
 

2024 Plan and 2024 ESPP

     203  
 

Homology 401(k) Plan

     203  
 

Additional Agreements

     203  
 

Conditions to the Completion of the Merger

     204  
 

Termination and Termination Fees

     205  
 

Amendment and Waiver

     207  
 

Fees and Expenses

     208  

AGREEMENTS RELATED TO THE MERGER

     209  
 

Support Agreements

     209  
 

Lock-Up Agreements

     210  
 

The Q32 Pre-Closing Financing

     211  
 

Contingent Value Rights Agreement

     211  

MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES OF THE MERGER

     220  

THE SPECIAL MEETING OF HOMOLOGY STOCKHOLDERS

     224  
 

Date, Time and Place

     224  
 

Purposes of the Homology Special Meeting

     224  
 

Recommendation of the Homology Board of Directors

     224  
 

Record Date and Voting Power

     225  
 

Voting and Revocation of Proxies

     225  
 

Required Vote

     226  
 

Solicitation of Proxies

     228  

 

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MATTERS BEING SUBMITTED TO A VOTE OF HOMOLOGY STOCKHOLDERS

     229  
 

PROPOSAL NO. 1: APPROVAL OF THE ISSUANCE OF COMMON STOCK IN THE MERGER AND THE CHANGE OF CONTROL RESULTING FROM THE MERGER

     229  
 

PROPOSAL NO. 2: APPROVAL OF THE AMENDMENT TO THE RESTATED CERTIFICATE OF INCORPORATION OF HOMOLOGY EFFECTING THE AUTHORIZED SHARE INCREASE

     231  
 

PROPOSAL NO. 3: APPROVAL OF THE AMENDMENT TO THE RESTATED CERTIFICATE OF INCORPORATION OF HOMOLOGY EFFECTING THE REVERSE STOCK SPLIT

     233  
 

PROPOSAL NO. 4: APPROVAL OF THE 2024 STOCK OPTION AND INCENTIVE PLAN

     243  
 

PROPOSAL NO. 5: APPROVAL OF THE 2024 EMPLOYEE STOCK PURCHASE PLAN

     250  
 

PROPOSAL NO. 6: APPROVAL OF ADJOURNMENT OF THE HOMOLOGY SPECIAL MEETING

     254  

HOMOLOGY’S BUSINESS

     255  

Q32’S BUSINESS

     305  

HOMOLOGY MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

     346  

Q32 MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

     367  

MANAGEMENT FOLLOWING THE MERGER

     388  

SELECTED HISTORICAL CONSOLIDATED FINANCIAL DATA

     393  

UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL DATA

     396  

UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION

     398  

Q32 EXECUTIVE AND DIRECTOR COMPENSATION

     411  

CERTAIN RELATED PERSON TRANSACTIONS OF HOMOLOGY

     419  

CERTAIN RELATED PERSON TRANSACTIONS OF THE COMBINED COMPANY

     421  

HOMOLOGY’S DESCRIPTION OF CAPITAL STOCK

     426  

COMPARISON OF RIGHTS OF HOLDERS OF HOMOLOGY CAPITAL STOCK AND Q32 CAPITAL STOCK

     430  

PRINCIPAL STOCKHOLDERS OF HOMOLOGY

     440  
PRINCIPAL STOCKHOLDERS OF Q32      442  
PRINCIPAL STOCKHOLDERS OF COMBINED COMPANY      446  
LEGAL MATTERS      449  
EXPERTS      449  
WHERE YOU CAN FIND MORE INFORMATION      450  
OTHER MATTERS      451  
           Stockholder Proposals and Director Nominations      451  
  Householding of Proxy Statement/Prospectus      451  
INDEX TO FINANCIAL STATEMENTS      F-1  
Annex A-Agreement and Plan of Merger      A-1  
Annex B-Form of Homology Stockholder Support Agreement      B-1  
Annex C-Form of Q32 Stockholder Support Agreement      C-1  
Annex D-Form of Contingent Value Rights Agreement      D-1  
Annex E-Form of Homology Lock-Up Agreement      E-1  
Annex F-Form of Q32 Lock-Up Agreement      F-1  

 

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Annex G-Certificate of Amendment Effecting the Authorized Share Increase and the Reverse Stock Split      G-1  
Annex H-Opinion of Cowen and Company, LLC      H-1  
Annex I-2024 Stock Option and Incentive Plan      I-1  
Annex J-2024 Employee Stock Purchase Plan      J-1  
Annex K-Appraisal Rights (Section 262 of the Delaware General Corporation Law)      K-1  

 

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CAUTIONARY STATEMENT CONCERNING FORWARD-LOOKING STATEMENTS

This proxy statement/prospectus contains forward-looking statements relating to Homology, Q32, the Merger, the combined company, and the other proposed transactions.

These forward-looking statements are based on current expectations and beliefs and involve numerous risks and uncertainties that could cause actual results to differ materially from expectations. These forward-looking statements should not be relied upon as predictions of future events as Homology and Q32 cannot assure you that the events or circumstances reflected in these statements will be achieved or will occur. You can identify forward-looking statements by the use of forward-looking terminology including “believes,” “expects,” “may,” “will,” “should,” “seeks,” “intends,” “plans,” “pro forma,” “estimates” or “anticipates” or the negative of these words and phrases or other variations of these words and phrases or comparable terminology. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements include, but are not limited to, any statements regarding the strategies, prospects, plans, expectations or objectives of management of Homology or Q32 for future operations of the combined company, the progress, scope or timing of the development of the combined company’s product candidates, the expectations surrounding the potential safety, efficacy, and regulatory and clinical progress of Q32’s product candidates, including bempikibart and ADX-097, and anticipated milestones and timing therefor, the benefits that may be derived from any future products or the commercial or market opportunity with respect to any future products of the combined company, the ability of the combined company to protect its intellectual property rights, the anticipated operations, financial position, ability to raise capital to fund operations, revenues, costs or expenses of Homology, Q32 or the combined company, statements regarding future economic conditions or performance, statements of belief and any statement of assumptions underlying any of the foregoing. Forward-looking statements may also include any statements regarding the approval and closing of the Merger, including the conditions to and timing of closing of the Merger, the location and management of the combined company, the percentage ownership of the combined company, and the parties’ ability to consummate the proposed transaction, the Pre-Closing Financing, the composition of the board of directors of the combined company, the expected issuance of the CVRs and the contingent payments contemplated by the CVRs, the combined company’s expected cash and the sufficiency of the combined company’s cash, cash equivalents and short-term investments to fund operations into mid-2026, the listing of the combined company’s shares on Nasdaq, and any statement of assumptions underlying any of the foregoing.

For a discussion of the factors that may cause Homology, Q32 or the combined company’s actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied in such forward-looking statements, or for a discussion of risks associated with the ability of Homology and Q32 to complete the Merger and the effect of the Merger on the business of Homology, Q32 and the combined company, see the section titled “Risk Factors” beginning on page 29 of this proxy statement/prospectus.

If any of these risks or uncertainties materialize or any of these assumptions prove incorrect, the results of Homology, Q32 or the combined company could differ materially from the forward-looking statements. All forward-looking statements in this proxy statement/prospectus are current only as of the date of this proxy statement/prospectus. Homology and Q32 do not undertake any obligation to (and expressly disclaim any such obligation to) publicly update any forward-looking statement to reflect events or circumstances after the date of this proxy statement/prospectus or to reflect the occurrence of unanticipated events.

 

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QUESTIONS AND ANSWERS

The following section provides answers to frequently asked questions about the Merger, general information about the Homology Special Meeting and voting. For some questions, this section provides only summary information. For a more complete response to these questions and for additional information, please refer to the cross-referenced sections.

Questions and Answers About the Merger

 

Q:

What is the Merger?

 

A:

Homology and Q32 have entered into the Merger Agreement, dated as of November 16, 2023, a copy of which is attached as Annex A to this proxy statement/prospectus. The Merger Agreement contains the terms and conditions of the proposed business combination of Homology and Q32. Pursuant to the Merger Agreement, Merger Sub, a direct, wholly owned subsidiary of Homology, will merge with and into Q32, with Q32 surviving as a wholly owned subsidiary of Homology and the surviving corporation. In connection with the Merger, Homology will change its corporate name to “Q32 Bio Inc.” In connection with the Merger, Homology is focusing on exploring strategic alternatives for its programs and platform technology, including the sale of its ownership position in Oxford Biomedica Solutions LLC, or Oxford Solutions, a contract development and manufacturing organization, or CDMO, jointly established by Homology and Oxford Biomedica plc, and the sale of its assets, rights and interests in its program to develop HMI-103 for the treatment of PKU. Upon completion of the Merger, the business of Q32 will continue as the business of the combined company.

Immediately after the Merger, Homology securityholders as of immediately prior to the Merger are expected to own approximately 25% of the outstanding shares of the combined company on a fully-diluted basis and former Q32 securityholders (including purchasers in the Pre-Closing Financing) are expected to own approximately 75% of the outstanding shares of the combined company on a fully-diluted basis, subject to certain assumptions, including, but not limited to, Homology’s net cash as of closing being equal to $60.0 million and Q32 receiving $42.0 million in gross proceeds in exchange for issuance of Q32 common stock in the Pre-Closing Financing described elsewhere in this proxy statement/prospectus. Under certain circumstances further described in the Merger Agreement, the ownership percentages may be adjusted up or down including, but not limited to, if Homology’s net cash as of closing is lower than $59.5 million or greater than $60.5 million.

At the Effective Time, each share of Q32 common stock (after giving effect to the conversion of each share of Q32’s preferred stock into Q32 common stock and the conversion of Q32’s convertible notes into Q32 common stock and including all such shares that are converted into Q32 common stock) will be converted into the right to receive a number of shares of Homology common stock equal to the total number of shares of Homology common stock to be issued in the Merger multiplied by the applicable Q32 stockholder’s percentage interest in Q32 as set forth in the Allocation Certificate, and as described in more detail in the section titled “The Merger Agreement—Allocation Certificate” beginning on page 188 of the accompanying proxy statement/prospectus. The Q32 common stock that will be converted in the Merger includes Q32 common stock to be issued pursuant to the subscription agreement by and among Q32 and certain investors to purchase shares of Q32’s common stock for an aggregate purchase price of approximately $42.0 million, which transaction is referred to as the Pre-Closing Financing. If any Q32 common stock outstanding immediately prior to the Effective Time is unvested or is subject to a repurchase option or a risk of forfeiture under any applicable agreement with Q32, then the shares of Homology common stock issued in exchange for such shares of Q32 common stock will to the same extent be unvested and subject to the same repurchase option or risk of forfeiture, and such shares of Homology common stock will be marked with appropriate legends.

In connection with the Merger, each option to purchase shares of Q32 common stock outstanding as of immediately prior to the Effective Time will be assumed by Homology and converted, at the Effective

 

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Time, into an option to acquire, on the same terms and conditions (including the same vesting and exercisability terms and conditions), the number of shares of Homology common stock equal to the number of shares of Q32 common stock subject to such option as of immediately prior to the Effective Time multiplied by the exchange ratio formula in the Merger Agreement and rounding that result down to the nearest whole number of shares, at a per share exercise price equal to the per share exercise price of such option immediately prior to the Effective Time multiplied by the exchange ratio formula in the Merger Agreement, rounded up to the nearest whole cent, as described in more detail in the section titled “The Merger Agreement—Treatment of Q32 Options” beginning on page 191 of this proxy statement/prospectus. In addition, at the Effective Time, each unexercised warrant to purchase shares of Q32 common stock outstanding immediately prior to the Effective Time will be assumed by Homology and converted into a warrant to purchase shares of Homology’s common stock, with adjustments to the number of shares and the exercise price to reflect the exchange ratio formula in the Merger Agreement, as described in more detail in the section titled “The Merger Agreement—Treatment of Q32 Warrants” beginning on page 191 of this proxy statement/prospectus.

Each outstanding Homology ITM Option will vest in full immediately prior to the Effective Time and remain outstanding, subject to proportionate adjustment in accordance with the terms of Homology’s 2018 Incentive Award Plan or 2015 Stock Incentive Plan, as applicable, to reflect the Reverse Stock Split and the issuance of the CVRs, and each option to purchase Homology common stock that is not a Homology ITM Option will be cancelled for no consideration immediately prior to the Effective Time. Each Homology Restricted Stock Unit that is outstanding will vest in full immediately prior to the Effective Time, and the holder of each unsettled Homology Restricted Stock Unit will receive immediately prior to the Effective Time, the number of shares of Homology common stock equal to the number of vested and unsettled shares of Homology common stock underlying such Homology Restricted Stock Unit.

 

Q:

Why are the two companies proposing to combine?

 

A:

Homology and Q32 believe that combining the two companies will result in a company with a robust pipeline, strong leadership team and substantial capital resources, positioning it to become a leading company researching, developing and commercializing therapies for diseases. The combined company will focus on developing Q32’s product candidates, and it is anticipated that the combined company will not continue to develop Homology’s legacy product candidates. For a more complete description of the reasons for the Merger, please see the sections titled “The Merger—Homology Reasons for the Merger” and “The Merger—Q32 Reasons for the Merger” beginning on pages 161 and 164, respectively, of this proxy statement/prospectus.

 

Q:

What will Q32 securityholders receive in the Merger?

 

A:

Q32 stockholders will receive shares of Homology common stock in the Merger, allocated based on the applicable Q32 stockholder’s percentage interest in Q32 as set forth in the Allocation Certificate. Immediately after the Merger, former Q32 securityholders (including purchasers in the Pre-Closing Financing) are expected to own approximately 75% of the outstanding shares of the combined company on a fully-diluted basis, subject to certain assumptions, including, but not limited to, Homology’s net cash as of closing being equal to $60.0 million and Q32 issuing approximately $42.0 million of Q32 common stock in the Pre-Closing Financing described elsewhere in this proxy statement/prospectus. Under certain circumstances further described in the Merger Agreement, the ownership percentages may be adjusted up or down including, but not limited to, if Homology’s net cash as of closing is lower than $59.5 million or greater than $60.5 million. If any Q32 common stock outstanding immediately prior to the Effective Time is unvested or is subject to a repurchase option or a risk of forfeiture under any applicable agreement with Q32, then the shares of Homology common stock issued in exchange for such shares of Q32 common stock will to the same extent be unvested and subject to the same repurchase option or risk of forfeiture, and such shares of Homology common stock will be marked with appropriate legends.

 

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In connection with the Merger, each option to purchase shares of Q32 common stock outstanding as of immediately prior to the Effective Time will be assumed by Homology and converted, at the Effective Time, into an option to acquire, on the same terms and conditions (including the same vesting and exercisability terms and conditions), the number of shares of Homology common stock equal to the number of shares of Q32 common stock subject to such option as of immediately prior to the Effective Time multiplied by the exchange ratio formula in the Merger Agreement and rounding that result down to the nearest whole number of shares, at a per share exercise price equal to the per share exercise price of such option immediately prior to the Effective Time multiplied by the exchange ratio formula in the Merger Agreement, rounded up to the nearest whole cent.

At the Effective Time, each unexercised warrant to purchase shares of Q32 common stock outstanding immediately prior to the Effective Time will be assumed by Homology and converted into a warrant to purchase shares of Homology’s common stock, with adjustments to the number of shares and the exercise price to reflect the exchange ratio formula in the Merger Agreement.

Immediately prior to the Effective Time, Q32 will cause the outstanding principal and accrued but unpaid interest on the convertible notes issued by Q32 on May 20, 2022, or the Q32 Convertible Notes, to be converted into the number of shares of Q32 common stock provided for under the terms of such Q32 Convertible Note, or the Q32 Note Conversion. In addition, outstanding preferred stock of Q32, or the Q32 Preferred Stock, will be converted into Q32 common stock immediately prior to the Effective Time in accordance with, and pursuant to the terms and conditions of, the organizational documents of Q32, or the Q32 Preferred Stock Conversion. In connection with the Merger, all shares of Q32 common stock issued pursuant to the Q32 Note Conversion and the Q32 Preferred Stock Conversion will be cancelled and converted into the right to receive Homology common stock in accordance with the terms of the Merger Agreement.

For a more complete description of what Q32 securityholders will receive in the Merger, please see the sections titled “The Merger Agreement—Merger Consideration,” “The Merger Agreement—Treatment of Q32 Warrants” and “The Merger Agreement—Treatment of Q32 Options” beginning on pages 187, 191 and 191, respectively, of this proxy statement/prospectus.

 

Q:

Will the common stock of the combined company trade on an exchange?

 

A:

Shares of Homology common stock are currently listed on The Nasdaq Global Select Market, or Nasdaq, under the symbol “FIXX.” Q32 intends to file an initial listing application for the combined company with the Nasdaq Stock Market LLC. After completion of the Merger, Homology will be renamed “Q32 Bio Inc.” and it is expected that the common stock of the combined company will trade on Nasdaq under the symbol “QTTB.”

 

Q:

Who will be the directors of the combined company following the Merger?

 

A:

Immediately following the Merger, the combined company’s board of directors will be composed of nine members, consisting of (i) seven current Q32 board members, namely Jodie Morrison,         ,         ,         ,         ,          and         , and (ii) two current Homology board members, namely Arthur Tzianabos, Ph.D. and Mary Thistle. The staggered structure of the Homology board of directors will remain in place for the combined company following the completion of the Merger. The Homology board of directors has determined that each of the directors other than          meet the Nasdaq independence requirements.

It is anticipated the director classes of the combined company board of directors will be as follows:

 

  •  

Class I directors (term ending                 ):                .

 

  •  

Class II directors (term ending                 ):                .

 

  •  

Class III directors (term ending                 ):                .

 

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Q:

Who will be the executive officers of the combined company immediately following the Merger?

 

A:

Immediately following the Merger, the executive management team of the combined company is expected to consist of members of the Q32 executive management team prior to the Merger, including:

 

Name

  

Title

Jodie Morrison    President and Chief Executive Officer
Lee Kalowski    Interim Chief Financial Officer
Shelia Violette, Ph.D.    Founder & Chief Scientific Officer
Jason Campagna, M.D., Ph.D.    Chief Medical Officer

 

Q:

When do you expect the Merger to be consummated?

 

A:

The Merger is anticipated to close in the first quarter of 2024, but the exact timing cannot be predicted. For more information, please see the section titled “The Merger Agreement—Conditions to the Completion of the Merger” beginning on page 204 of this proxy statement/prospectus.

 

Q:

As a Homology stockholder, how does Homology’s board of directors recommend that I vote?

 

A:

After careful consideration, Homology’s board of directors unanimously recommends that Homology stockholders vote “FOR” all of the proposals.

 

Q:

What risks should I consider in deciding whether to vote in favor of the Merger?

 

A:

You should carefully review the section titled “Risk Factors” beginning on page 29 of this proxy statement/prospectus, which set forth certain risks and uncertainties related to the Merger, risks and uncertainties to which the combined company’s business will be subject, and risks and uncertainties to which each of Homology and Q32, as independent companies, are subject.

 

Q:

What is the Q32 Pre-Closing Financing?

 

A:

On November 16, 2023, concurrently with the execution and delivery of the Merger Agreement, Q32 entered into a subscription agreement, or the Subscription Agreement, with certain accredited investors named therein, pursuant to which the investors agreed to purchase shares of Q32 common stock for aggregate gross proceeds of approximately $42.0 million to Q32, which private placement is referred to herein as the Pre-Closing Financing. The closing of the Pre-Closing Financing is conditioned upon the satisfaction or waiver of the conditions to the closing of the Merger as well as certain other conditions. Immediately after the Merger, the shares of Q32 common stock issued in the Pre-Closing Financing are expected to represent approximately 13.2% of the outstanding shares of the combined company. Q32 and the investors participating in the Pre-Closing Financing have also agreed to enter into a registration rights agreement at the closing of the Pre-Closing Financing, pursuant to which, among other things, the combined company will agree to provide for registration rights for certain shares of the combined company’s common stock that are held by the investors participating in the Pre-Closing Financing from time to time.

 

Q:

What are the CVRs being issued to Homology stockholders?

 

A:

Prior to the Effective Time, Homology and Equiniti Trust Company, LLC, as Rights Agent, will enter into a Contingent Value Rights Agreement, or the CVR Agreement, pursuant to which Homology stockholders of record as of the close of business on the last business day prior to the day on which the Effective Time occurs will receive one CVR for each outstanding share of Homology common stock held by such stockholder on such date. A copy of the form of CVR Agreement is included as Annex D to this proxy statement/prospectus.

 

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Each CVR will represent the contractual right to receive payments from Homology upon the actual receipt by Homology or its subsidiaries of certain contingent proceeds derived from any cash consideration that is paid to Homology or its subsidiaries as a result of the sale, transfer, license, assignment or other divestiture, disposition or commercialization of the following, or the Legacy Assets, and such disposition, a Legacy Asset Disposition: any of Homology’s assets, rights and interests relating to Homology’s HMI-103 product candidate (Adult/Pediatric PKU), HMI-204 product candidate (MLD) and Homology’s Capsids and AAVHSC Platform, including any equity interests held directly or indirectly by Homology in Oxford Biomedica Solutions LLC or its affiliates, or OXB Solutions, pursuant to that certain Equity Securities Purchase Agreement, dated as of January 28, 2022, by and between Homology and OXB Solutions, in which Homology currently owns 20% of the fully diluted equity interests in OXB Solutions and Homology is entitled to exercise a put option to sell or transfer Homology’s equity interests in OXB Solutions set forth therein on March 10, 2025, such interests, the Oxford Assets. Payments of the proceeds from a Legacy Asset Disposition will be net of certain taxes, transaction costs and certain other expenses.

The contingent payments under the CVR Agreement, if they become payable, will become payable to the Rights Agent for subsequent distribution to the holders of the CVRs. In the event there is no Legacy Asset Disposition (other than with respect to the Oxford Assets) prior to the 18-month anniversary of the closing date of the Merger, or the Closing Date, holders will not receive any payments pursuant to the CVR Agreement with respect to the Legacy Assets (other than possibly the Oxford Assets). If no disposition of the Oxford Assets occurs prior to the 24-month anniversary of the Closing Date, holders will not receive any payments pursuant to the CVR Agreement with respect to the Oxford Assets. There can be no assurance than any Legacy Asset Disposition (including the disposition of Oxford Assets) will occur or that any holders of CVRs will receive payments with respect thereto.

The right to the contingent payments contemplated by the CVR Agreement is a contractual right only and will not be transferable, except in the limited circumstances specified in the CVR Agreement. The CVRs will not be evidenced by a certificate or any other instrument and will not be registered with the SEC. The CVRs will not have any voting or dividend rights and will not represent any equity or ownership interest in Homology or the combined company or any of its subsidiaries. No interest will accrue on any amounts payable in respect of the CVRs.

For a more detailed description of the CVRs and the CVR Agreement, see “Agreements Related to the Merger—Contingent Value Rights Agreement” beginning on page 211 of this proxy statement/prospectus.

 

Q:

What are the material U.S. federal income tax consequences of the issuance of the CVRs and of the receipt of payments on the CVRs (if any) to holders of Homology common stock?

 

A:

The U.S. federal income tax treatment of the CVRs and payments (if any) thereon is uncertain. Except to the extent otherwise required pursuant to a change in applicable law after the date of the CVR Agreement, neither Homology nor the Rights Agent will report the issuance of the CVRs as a current distribution and will report each payment (if any) on the CVRs as a distribution by Homology for U.S. federal income tax purposes. This position may be challenged by the Internal Revenue Service, or the IRS, in which case holders of Homology common stock could be required to recognize taxable income in respect of the issuance of the CVRs without a corresponding receipt of cash. See the section titled “Agreements Related to the Merger—Contingent Value Rights Agreement—Material U.S. Federal Income Tax Consequences of the CVRs to Holders of Homology Common Stock” beginning on page 215 for a discussion of the material U.S. federal income tax consequences of the issuance of the CVRs and the receipt of payments (if any) thereon to holders of Homology common stock.

 

Q:

What are the material U.S. federal income tax consequences of the Merger to holders of Q32 common stock?

 

A:

Homology and Q32 intend the Merger to qualify as a “reorganization” within the meaning of Section 368(a) of the Internal Revenue Code of 1986, as amended, or the Code. Assuming the Merger qualifies as a

 

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  “reorganization” within the meaning of Section 368(a) of the Code, subject to the limitations and qualifications described in the section titled “Material U.S. Federal Income Tax Consequences of the Merger” beginning on page 220, holders of Q32 common stock that exchange their Q32 stock for Homology common stock in the Merger generally should not recognize gain or loss for U.S. federal income tax purposes on such exchange. However, if the Merger does not qualify as a “reorganization” within the meaning of Section 368(a) of the Code, the Merger would be a taxable transaction to U.S. Holders (as defined in the section titled “Material U.S. Federal Income Tax Consequences of the Merger”), but Non-U.S. Holders (as defined in the section titled “Material U.S. Federal Income Tax Consequences of the Merger”) generally would not be subject to U.S. federal income tax on any gain realized in connection with the Merger.

The closing of the Merger is not conditioned upon the receipt of an opinion of counsel or a ruling from the IRS regarding the U.S. federal income tax treatment of the Merger, and no opinion of counsel or ruling from the IRS will be requested regarding such treatment. Accordingly, there can be no assurance that the IRS will not challenge the qualification of the Merger as a “reorganization” within the meaning of Section 368(a) of the Code or that a court will not sustain such a challenge by the IRS.

The tax consequences to you of the Merger will depend on your particular facts and circumstances. Please consult your tax advisor as to the tax consequences of the Merger in your particular circumstances, including the applicability and effect of U.S. federal, state, local and foreign income and other tax laws. For a more detailed discussion of the material U.S. federal income tax consequences of the Merger, see “Material U.S. Federal Income Tax Consequences of the Merger” beginning on page 220.

Questions and Answers About the Homology Special Meeting and Voting

 

Q:

Who is entitled to vote at the Homology Special Meeting?

 

A:

Holders of record of shares of Homology common stock as of the close of business on             , 2024, or the Record Date, are entitled to notice of and to vote at the Homology Special Meeting and any continuation, postponement or adjournment thereof. At the close of business on the Record Date, there were                shares of Homology common stock issued and outstanding and entitled to vote. Each share of Homology common stock is entitled to one vote on any matter presented to stockholders at the Homology Special Meeting.

 

Q:

How do I attend the Homology Special Meeting?

 

A:

The Homology Special Meeting will be held on                , 2024 at a.m. Eastern Time via a live webcast. You will need the control number that appears on your proxy card, or the Control Number, to attend the meeting. If your shares are held in “street name”, you should use your Control Number provided on your notice or voting instruction form, or otherwise vote through the bank, broker or other nominee. The meeting webcast will begin promptly at                  a.m. Eastern Time. You are encouraged to access the meeting prior to the start time. Homology will have technicians ready to assist you with any technical difficulties you may have accessing the virtual meeting website by calling the technical support number provided by email one hour prior to the Homology Special Meeting.

 

Q:

What proposals will be voted on at the Homology Special Meeting?

 

A:

Pursuant to the terms of the Merger Agreement, the Stock Issuance Proposal must be approved by the requisite stockholder vote at the Homology Special Meeting in order for the Merger to close. Approval of the Authorized Share Increase Proposal and the Reverse Stock Split Proposal are also conditions to completion of the Merger. Therefore, the Merger cannot be consummated without the approval of the Stock Issuance Proposal, the Authorized Share Increase Proposal and the Reverse Stock Split Proposal.

In addition, each of the other closing conditions set forth in the Merger Agreement must be satisfied or waived for the Merger to close. For a more complete description of the closing conditions under the Merger

 

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Agreement, please see the section titled “The Merger Agreement—Conditions to the Completion of the Merger” beginning on page 204 of this proxy statement/prospectus.

At the Homology Special Meeting, the holders of Homology common stock will also be asked to consider the following proposals:

 

  •  

A proposal to approve the 2024 Stock Option and Incentive Plan;

 

  •  

A proposal to approve the 2024 Employee Stock Purchase Plan; and

 

  •  

A proposal to adjourn the Homology Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of the Stock Issuance Proposal, the Authorized Share Increase Proposal and the Reverse Stock Split Proposal.

The approval of the Stock Option and Incentive Plan Proposal, the ESPP Proposal and the Adjournment Proposal is not a condition to the Merger closing.

 

Q:

What are the material U.S. federal income tax consequences of the proposed Reverse Stock Split to U.S. Holders of Homology common stock?

 

A:

A U.S. Holder (as defined in the section titled “Matters Being Submitted to a Vote of Homology Stockholders—Proposal No. 3: Approval of the Amendment to the Restated Certificate of Incorporation of Homology Effecting the Reverse Stock Split—Material U.S. Federal Income Tax Consequences of the Reverse Stock Split to U.S. Holders of Homology Common Stock” beginning on page 240) of Homology common stock generally should not recognize gain or loss upon the proposed Reverse Stock Split, except to the extent such holder receives cash in lieu of a fractional share of Homology common stock, and subject to the discussion in the section titled “Matters Being Submitted to a Vote of Homology Stockholders—Proposal No. 3: Approval of the Amendment to the Restated Certificate of Incorporation of Homology Effecting the Reverse Stock Split—Material U.S. Federal Income Tax Consequences of the Reverse Stock Split to U.S. Holders of Homology Common Stock” beginning on page 240, which provides a more complete description of the material U.S. federal income tax consequences of the Reverse Stock Split to U.S. Holders of Homology common stock, including possible alternative treatments.

 

Q:

As a Homology stockholder, how does Homology’s board of directors recommend that I vote?

 

A:

After careful consideration, Homology’s board of directors unanimously recommends that Homology stockholders vote “FOR” all of the proposals.

 

Q:

How do I vote my shares?

 

A:

Homology recommends that stockholders vote by proxy even if they plan to attend the Homology Special Meeting and vote electronically. If you are a stockholder of record, there are three ways to vote by proxy:

 

  •  

by Telephone-You can vote by telephone by calling              and following the instructions on the proxy card;

 

  •  

by Internet-You can vote over the Internet at              by following the instructions on the proxy card; or

 

  •  

by Mail-You can vote by mail by signing, dating and mailing the proxy card, which you may have received by mail.

Telephone and Internet voting facilities for stockholders of record will be available 24 hours a day and will close at 11:59 p.m. Eastern Time on                 , 2024.

If you attend the Homology Special Meeting online, you will need the 16-digit control number included on your proxy card or on the instructions that accompanied your proxy materials to vote electronically during the meeting.

 

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Whether or not you expect to attend the Homology Special Meeting online, we urge you to vote your shares as promptly as possible to ensure your representation and the presence of a quorum at the Homology Special Meeting. If you submit your proxy, you may still decide to attend the Homology Special Meeting and vote your shares electronically.

If your shares are held in “street name” through a bank or broker, you will receive instructions on how to vote from the bank or broker. You must follow their instructions in order for your shares to be voted. Internet and telephone voting also may be offered to stockholders owning shares through certain banks and brokers. If your shares are not registered in your own name and you would like to vote your shares electronically at the Homology Special Meeting, you should contact your bank or broker to obtain your 16-digit control number or otherwise vote through the bank or broker. If you lose your 16-digit control number, you may join the Homology Special Meeting as a “Guest” but you will not be able to vote, ask questions or access the list of stockholders as of the Record Date. You will need to obtain your own Internet access if you choose to attend the Homology Special Meeting online and/or vote over the Internet.

 

Q:

What is the difference between being a “record holder” and holding shares in “street name”?

 

A:

A record holder (also called a “registered holder”) holds shares in his or her name. Shares held in “street name” means that shares are held in the name of a bank, broker or other nominee on the holder’s behalf.

 

Q:

What do I do if my shares are held in “street name”?

 

A:

If your shares are held in a brokerage account or by a bank or other holder of record, you are considered the “beneficial owner” of shares held in “street name.” This proxy statement/prospectus has been forwarded to you by your broker, bank or other nominee who is considered, with respect to those shares, the stockholder of record. As the beneficial owner, you have the right to direct your broker, bank or nominee on how to vote your shares by following their instructions for voting. Please refer to the information from your bank, broker or other nominee on how to submit your voting instructions.

 

Q:

What are broker non-votes?

 

A:

A “broker non-vote” occurs when shares held by a broker in “street name” for a beneficial owner are not voted with respect to a proposal because (1) the broker has not received voting instructions from the stockholder who beneficially owns the shares and (2) the broker lacks the authority to vote the shares at their discretion.

A broker is entitled to vote shares held for a beneficial owner on routine matters without instructions from the beneficial owner of those shares. On the other hand, absent instructions from the beneficial owner of such shares, a broker is not entitled to vote shares held for a beneficial owner on non-routine matters.

It is anticipated that all of the proposals currently scheduled for consideration at the Homology Special Meeting will be considered “non-routine” matters, and a broker will lack the authority to vote shares at its discretion on such proposals. Consequently, Homology expects that there will not be any broker non-votes at the Homology Special Meeting. If broker non-votes were received, they would not have any impact on the outcome of the proposals.

 

Q:

How many shares must be present to hold the Homology Special Meeting?

 

A:

A quorum must be present at the Homology Special Meeting for any business to be conducted. The holders of a majority in voting power of Homology capital stock issued and outstanding and entitled to vote, present by remote communication or represented by proxy, constitutes a quorum. If you sign and return your paper proxy card or authorize a proxy to vote electronically or telephonically, your shares will be counted to determine whether there is a quorum even if you abstain or fail to vote.

 

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Broker non-votes will also be considered present for the purpose of determining whether there is a quorum for the Homology Special Meeting.

 

Q:

What if a quorum is not present at the Homology Special Meeting?

 

A:

If a quorum is not present or represented at the scheduled time of the Homology Special Meeting, (i) the chairperson of the Homology Special Meeting or (ii) a majority in voting power of the stockholders entitled to vote at the Homology Special Meeting, present in person, or by remote communication, if applicable, or represented by proxy, may adjourn the Homology Special Meeting until a quorum is present or represented.

 

Q:

How many votes are required to approve each proposal?

 

A:

The table below summarizes the proposals that will be voted on, the vote required to approve each item and how votes are counted:

 

Proposal

  

Votes Required

   Voting Options    Impact of
“Abstain”
Votes and
Broker
Non-Votes
Proposal No. 1: Approval of the Issuance of Common Stock in the Merger and the Change of Control Resulting from the Merger    The affirmative vote of the stockholders of a majority in voting power of the votes cast affirmatively or negatively at the Homology Special Meeting by the stockholders entitled to vote thereon.    “FOR”

“AGAINST”

“ABSTAIN”

   None(1)
Proposal No. 2: Approval of the Amendment to the Restated Certificate of Incorporation of Homology Effecting the Authorized Share Increase    The affirmative vote of the stockholders of a majority in voting power of the votes cast affirmatively or negatively at the Homology Special Meeting by the stockholders entitled to vote thereon.    “FOR”

“AGAINST”

“ABSTAIN”

   None(1)
Proposal No. 3: Approval of the Amendment to the Restated Certificate of Incorporation of Homology Effecting the Reverse Stock Split    The affirmative vote of the stockholders of a majority in voting power of the votes cast affirmatively or negatively at the Homology Special Meeting by the stockholders entitled to vote thereon.    “FOR”

“AGAINST”

“ABSTAIN”

   None(1)
Proposal No. 4: Approval of the 2024 Stock Option and Incentive Plan    The affirmative vote of the stockholders of a majority in voting power of the votes cast affirmatively or negatively at the Homology Special Meeting by the stockholders entitled to vote thereon.    “FOR”

“AGAINST”

“ABSTAIN”

   None(1)
Proposal No. 5: Approval of the 2024 Employee Stock Purchase Plan    The affirmative vote of the stockholders of a majority in voting power of the votes cast affirmatively or negatively at the Homology Special Meeting by the stockholders entitled to vote thereon.    “FOR”

“AGAINST”

“ABSTAIN”

   None(1)
Proposal No. 6: Approval of Adjournment of the Homology Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of the Stock Issuance Proposal, the Authorized Share Increase Proposal and the Reverse Stock Split Proposal    The affirmative vote of the stockholders of a majority in voting power of the votes cast affirmatively or negatively at the Homology Special Meeting by the stockholders entitled to vote thereon.    “FOR”

“AGAINST”

“ABSTAIN”

   None(1)

 

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(1)

A vote marked as an “Abstention” is not considered a vote cast and will, therefore, not affect the outcome of this proposal.

Certain directors and executive officers of Homology have entered into stockholder support agreements pursuant to which they have agreed to vote all shares of Homology common stock owned by them as of the Record Date in favor of the Stock Issuance Proposal, the Authorized Share Increase Proposal and the Reverse Stock Split Proposal and against any competing “acquisition proposal” (as defined in the support agreements). As of the Record Date, the directors and certain executive officers of Homology owned or controlled     % of the outstanding shares of Homology common stock entitled to vote at the Homology Special Meeting.

 

Q:

What happens if I do not vote or submit a proxy but do not provide voting instructions?

 

A:

Failure to vote will have no effect on any of the proposals. If you submit a proxy but do not provide any voting instructions, the persons named as proxies will vote in accordance with the recommendations of the Homology board of directors. The Homology board of director’s recommendations are set forth above, as well as with the description of each proposal in this proxy statement/prospectus.

 

Q:

Can I revoke or change my vote after I submit my proxy?

 

A:

Yes. If you are a stockholder of record, you may revoke your proxy and change your vote:

 

  •  

by submitting a duly executed proxy bearing a later date;

 

  •  

by granting a subsequent proxy through the Internet or telephone;

 

  •  

by giving written notice of revocation to the Secretary of Homology prior to or at the Homology Special Meeting; or

 

  •  

by voting electronically at the Homology Special Meeting.

Your most recent proxy card or Internet or telephone proxy is the one that is counted. Your attendance at the Homology Special Meeting by itself will not revoke your proxy unless you give written notice of revocation to the Secretary of Homology before your proxy is voted or you vote electronically at the Homology Special Meeting.

 

Q:

How can I find out the results of the voting at the Homology Special Meeting?

 

A:

Preliminary voting results will be announced at the Homology Special Meeting. Final voting results will be published in a Current Report on Form 8-K, or Form 8-K, that Homology will file with the SEC within four business days after the Homology Special Meeting. If final voting results are not available in time to file a Form 8-K within four business days after the Homology Special Meeting, Homology intends to file a Form 8-K to publish preliminary results and, within four business days after the final results are known, file an additional Form 8-K to publish the final results.

 

Q:

What does it mean if I receive more than one set of proxy materials?

 

A:

It means that your shares are held in more than one account at the transfer agent and/or with banks, brokers or other nominees in “street name” as described below. Please vote all of your shares. To ensure that all of your shares are voted, for each set of proxy materials, please submit your proxy by phone, via the Internet, or, if you received printed copies of the proxy materials, by signing, dating and returning the enclosed proxy card in the enclosed envelope.

 

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Q:

Who can help answer my questions?

 

A:

If you are a Homology stockholder and would like additional copies of this proxy statement/prospectus without charge or if you have questions about the Homology Special Meeting, including the procedures for voting your shares, you should contact:

Homology Medicines, Inc.

One Patriots Park

Bedford, Massachusetts 01730

Telephone: Tel: (781) 327-2633

Attn: Paul Alloway, Ph.D.

If your shares are held in street name, please contact your bank, broker or other nominee.

To ensure timely delivery of documents prior to the Homology Special Meeting, any requests must be made no later than                 ,     .

 

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PROSPECTUS SUMMARY

This summary highlights selected information from this proxy statement/prospectus and may not contain all of the information that is important to you. To better understand the Merger and the proposals being considered at the Homology Special Meeting, you should read this entire proxy statement/prospectus carefully, including the Merger Agreement and the other annexes to which you are referred in this proxy statement/prospectus.

The Companies

Homology Medicines, Inc.

One Patriots Park

Bedford, MA 01730

Telephone: (781) 327-2633

Attn: Paul Alloway, Ph.D.

Homology is a clinical-stage genetic medicines company historically focused on transforming the lives of patients suffering from rare genetic diseases with significant unmet medical needs by addressing the underlying cause of the disease. Homology’s proprietary platform is designed to utilize its human hematopoietic stem cell-derived adeno-associated virus vectors, or AAVHSCs, to precisely and efficiently deliver single administration genetic medicines in vivo through a nuclease-free gene editing modality, gene therapy, or gene therapy to express antibodies platform, or GTx-mAb, which is designed to produce antibodies throughout the body. Homology’s former clinical programs include: HMI-103, an investigational gene editing candidate for the treatment of patients with phenylketonuria, or PKU, HMI-203, an investigational gene therapy candidate for the treatment of patients with mucopolysaccharidosis type II (MPS II), or Hunter syndrome, and HMI-102, an investigational gene therapy candidate for the treatment of adult patients with PKU. Homology’s former preclinical programs include: HMI-104, a GTx-mAb gene therapy candidate for the treatment of patients with paroxysmal nocturnal hemoglobinuria, or PNH, and HMI-204, a gene therapy candidate for metachromatic leukodystrophy, or MLD.

In July 2023, Homology announced that it had completed a review of its business and the Homology board of directors had approved a plan to explore, review and evaluate a range of potential strategic options available to Homology, including, without limitation, an acquisition, merger, reverse merger, sale of assets, strategic partnerships or other transactions. Based on the financing environment and Homology’s anticipated clinical development timeline for its lead program, HMI-103, Homology also announced that it was stopping further development of its programs and reduced its workforce by 86% in an effort to significantly reduce its ongoing operating costs as it evaluated strategic alternatives. The workforce reduction was substantially completed in the third quarter of 2023.

On November 16, 2023, Homology entered into the Merger Agreement with Q32 and Merger Sub. Upon completion of the Merger, the business of Q32 will continue as the business of the combined company.

Kenobi Merger Sub, Inc.

One Patriots Park

Bedford, MA 01730

Telephone: (781) 327-2633

Attn: Paul Alloway, Ph.D.

 

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Merger Sub is a direct, wholly owned subsidiary of Homology and was formed solely for the purpose of carrying out the Merger.

Q32 Bio Inc.

830 Winter Street

Waltham, MA 02451

Telephone: (781) 999-0232

Q32 is a clinical stage biotechnology company focused on developing novel biologics to effectively and safely restore healthy immune balance in patients with autoimmune and inflammatory diseases driven by pathological immune dysfunction. To achieve the goal of restoring homeostasis to a dysregulated immune system, Q32 is advancing antibody-based therapeutic candidates designed to target two central pathways of adaptive and innate immunity. The adaptive immune system is largely composed of T- and B-cell mediated cellular and antibody responses, while the innate immune system is the body’s first line of defense employing leukocytes that are responsible for clearing pathogens and cellular debris and modulating T- and B-cell function. Q32 believes that targeting these key pathways of immune dysregulation in autoimmune and inflammatory diseases will deliver therapeutics for indications with clear unmet medical need in the near term, while enabling it to build a broad and diverse pipeline in the long term. Q32 has multiple product candidates across a variety of autoimmune and inflammatory diseases with clinical readouts for its two lead programs expected in 2024 and 2025.

Bempikibart (ADX-914), Q32’s most advanced product candidate, is a fully human anti–interleukin-7 receptor alpha antagonist monoclonal antibody designed to re-regulate adaptive immune function by blocking signaling mediated by interleukin-7 and thymic stromal lymphopoietin. Bempikibart is being studied in two double-blind, placebo-controlled Phase 2 clinical trials designed to establish proof of clinical concept and evaluate Q32’s selected Phase 2 dose. One trial is evaluating the use of bempikibart for the treatment of atopic dermatitis and one is evaluating bempikibart for the treatment of alopecia areata. Enrollment in both clinical trials remains ongoing and Q32 remains on-track to report topline data from both Phase 2 clinical trials in the second half of 2024.

ADX-097, the lead product candidate from Q32’s complement inhibitor platform, is a humanized anti-C3d monoclonal antibody fusion protein. ADX-097 is designed to restore complement regulation – an integral part of the innate immune system – through a tissue-targeted mechanism. ADX-097 is designed to inhibit alternative pathway complement activation locally in diseased tissues where complement-mediated pathology is actively manifest. Q32 believes ADX-097 has the potential to drive improved clinical activity and address the limitations of the currently available systemic approaches to complement inhibition, including infection risk and the need for high drug doses and frequent administration, to achieve therapeutic levels of inhibition. Q32 is developing ADX-097 for the treatment of renal and other complement-mediated diseases of high unmet need, including lupus nephritis, immunoglobulin A nephropathy, complement component 3 glomerulopathy and anti-neutrophil cytoplasmic antibody-associated vasculitis. Q32 has completed dosing of healthy volunteers in a Phase 1 trial of ADX-097. Q32 expects to initiate an open-label Phase 2 renal basket program in the first half of 2024, with initial data expected by year-end 2024, and initiate a Phase 2 clinical trial in AAV, with topline data from both the renal basket and AAV trials anticipated in the second half of 2025.

In addition to ADX-097, Q32 is also engaged in additional pipeline efforts to expand therapeutic opportunities within complement-mediated diseases.

 

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Q32’s development pipeline is shown in the figure below.

LOGO

Note: AAV = Anti-Neutrophil Cytoplasmic Autoantibody (ANCA)-Associated Vasculitis; IgAN = IgA Nephropathy; LN = Lupus Nephritis; C3G = C3 Glomerulopathy. (1) Regained full development and commercial rights in November 2023.

The Merger (See page 153)

On November 16, 2023, Homology entered into the Merger Agreement with Q32 and Merger Sub, pursuant to which Merger Sub will merge with and into Q32, with Q32 surviving as a direct, wholly-owned subsidiary of Homology. In connection with the Merger, Homology will change its corporate name to “Q32 Bio Inc.” Upon completion of the Merger, the business of Q32 will continue as the business of the combined company.

Immediately after the Merger, Homology securityholders as of immediately prior to the Merger are expected to own approximately 25% of the outstanding shares of the combined company on a fully-diluted basis and former Q32 securityholders (including purchasers in the Pre-Closing Financing) are expected to own approximately 75% of the outstanding shares of the combined company on a fully-diluted basis, subject to certain assumptions, including, but not limited to, Homology’s net cash as of closing being equal to $60.0 million and Q32 issuing approximately $42.0 million of Q32 common stock in the Pre-Closing Financing described elsewhere in this proxy statement/prospectus. Under certain circumstances further described in the Merger Agreement, the ownership percentages may be adjusted up or down including, but not limited to, if Homology’s net cash as of closing is lower than $59.5 million or greater than $60.5 million.

At the Effective Time, each share of Q32 common stock (after giving effect to the conversion of each share of Q32’s preferred stock into Q32 common stock and the conversion of Q32’s convertible notes into Q32 common stock and including all such shares that are converted into Q32 common stock) will be converted into the right to receive a number of shares of Homology common stock equal to the total number of shares of Homology common stock to be issued in the Merger multiplied by the applicable Q32 stockholder’s percentage interest in Q32 as set forth in the Allocation Certificate. The Q32 common stock that will be converted in the Merger includes Q32 common stock to be issued pursuant to the subscription agreement by and among Q32 and certain investors to purchase shares of Q32’s common stock for an aggregate purchase price of approximately $42.0 million, which transaction is referred to as the Pre-Closing Financing. If any Q32 common stock outstanding immediately prior to the Effective Time is unvested or is subject to a repurchase option or a risk of forfeiture under any applicable agreement with Q32, then the shares of Homology common stock issued in exchange for such shares of Homology common stock will to the same extent be unvested and subject to the same repurchase option or risk of forfeiture, and such shares of Homology common stock will be marked with appropriate legends.

 

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In connection with the Merger, each option to purchase shares of Q32 common stock outstanding as of immediately prior to the Effective Time will be assumed by Homology and will be converted, at the Effective Time, into an option to acquire, on the same terms and conditions (including the same vesting and exercisability terms and conditions) as were applicable under the Q32 equity plan and applicable option agreement immediately prior to the Effective Time, the number of shares of Homology common stock equal to the number of shares of Q32 common stock subject to such option as of immediately prior to the Effective Time multiplied by the exchange ratio formula in the Merger Agreement and rounding that result down to the nearest whole number of shares, at a per share exercise price equal to the per share exercise price of such option immediately prior to the Effective Time multiplied by the exchange ratio formula in the Merger Agreement, rounded up to the nearest whole cent, and each unexercised warrant to purchase shares of Q32 common stock outstanding immediately prior to the Effective Time will be assumed by Homology and converted into a warrant to purchase shares of Homology common stock, with adjustments to the number of shares and the exercise price to reflect the exchange ratio formula in the Merger Agreement.

Each share of Homology common stock that is issued and outstanding at the Effective Time will remain issued and outstanding and such shares, subject to the Reverse Stock Split, will be unaffected by the Merger.

Each outstanding Homology ITM Option will vest in full immediately prior to the Effective Time and remain outstanding, subject to proportionate adjustment in accordance with the terms of Homology’s 2018 Incentive Award Plan or 2015 Stock Incentive Plan, as applicable, to reflect the Reverse Stock Split and the issuance of the CVRs, and each option to purchase Homology common stock that is not a Homology ITM Option will be cancelled for no consideration immediately prior to the Effective Time. Each Homology Restricted Stock Unit that is outstanding will vest in full immediately prior to the Effective Time, and the holder of each unsettled Homology Restricted Stock Unit will receive immediately prior to the Effective Time, the number of shares of Homology common stock equal to the number of vested and unsettled shares of Homology common stock underlying such Homology Restricted Stock Unit.

The Merger will be completed as promptly as practicable, but in no event later than two business days after all of the conditions precedent set forth in the Merger Agreement have been satisfied or waived (other than those conditions that, by their nature, are to be satisfied at the closing of the Merger) or at such other time, date and place as Homology and Q32 may mutually agree in writing, including the approval by the Homology stockholders of the issuance of Homology common stock in the Merger. The Merger is anticipated to close promptly after the Homology Special Meeting scheduled to be held on     , 2024. However, Homology and Q32 cannot predict the exact timing of the completion of the Merger because it is subject to the satisfaction or waiver of various conditions.

For a more complete description of the Merger, please see the sections titled “The Merger” and “The Merger Agreement” in this proxy statement/prospectus.

Reasons for the Merger (See pages 161 and 164)

Homology Reasons for the Merger

In the course of evaluating the Merger, the Homology board of directors held numerous meetings and consulted with Homology’s senior management, legal counsel and financial advisor, and, in reaching its decision to approve the Merger, the Homology board of directors considered a wide variety of factors, including, among others, the following material factors (which factors are not necessarily presented in any order of relative importance):

 

  •  

the review of the business, financial position and prospects of Homology on a standalone basis, and the determination that Homology could not reasonably be expected to fund its programs on a standalone basis without substantial additional investment;

 

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  •  

the current financial market conditions and historical market prices, volatility and trading information with respect to Homology common stock, as well as the unfavorable state of the capital-raising environment for biotechnology companies in general which would make it challenging for Homology to raise additional capital;

 

  •  

the review of the business, strategy, financial position and prospects of Q32 and, in that context, the potential for Q32’s clinical development pipeline to generate substantial long-term value for the combined company and its stockholders;

 

  •  

the view that no alternatives to the Merger (including remaining a standalone company, a liquidation or dissolution of Homology to distribute any available cash, and alternative strategic transactions) were reasonably likely to create greater value for Homology’s stockholders; and

 

  •  

that the Merger would provide Homology’s stockholders with (i) a significant opportunity to participate in the potential growth of the combined company following the Merger by virtue of their continued ownership of the combined company’s common stock, and (ii) the potential to receive certain cash payments following the closing of the Merger pursuant to the CVR Agreement.

Q32 Reasons for the Merger

In the course of reaching its decision to approve the Merger, the Q32 board of directors held numerous meetings, consulted with Q32’s senior management, its financial advisors and legal counsel, and considered a wide variety of factors, including, among others, the following material factors (which factors are not necessarily presented in any order of relative importance):

 

  •  

the Merger will potentially expand the access to capital and the range of investors available as a public company to support the clinical development of Q32’s pipeline, compared to the investors Q32 could otherwise gain access to if it continued to operate as a privately-held company;

 

  •  

the potential benefits from increased public market awareness of Q32 and its pipeline;

 

  •  

the historical and current information concerning Q32’s business, including its financial performance and condition, operations, management and pre-clinical data;

 

  •  

the expected financial position, operations, management structure and operating plans of the combined company (including the ability to support the combined company’s current and planned pre-clinical and clinical trials); and

 

  •  

the terms and conditions of the Merger Agreement.

Opinion of Homology’s Financial Advisor (See page 166)

Homology has engaged Cowen and Company, LLC, or TD Cowen, as Homology’s financial advisor in connection with the Merger. In connection with this engagement, TD Cowen delivered a written opinion, dated November 15, 2023, to the Homology board of directors as to the fairness, from a financial point of view and as of the date of such opinion, to Homology of the Q32 Equity Value provided for pursuant to the Merger Agreement. For purposes of TD Cowen’s financial analyses and opinion, the term “Q32 Equity Value” refers to the equity value of $195 million ascribed to Q32 pursuant to the Merger Agreement. The full text of TD Cowen’s written opinion, dated November 15, 2023, is attached as Annex H to this proxy statement/prospectus and is incorporated herein by reference. The summary of TD Cowen’s written opinion set forth herein is qualified in its entirety by reference to the full text of such opinion. TD Cowen’s analyses and opinion were prepared for and addressed to the Homology board of directors and were directed only to the fairness, from a financial point of view, to Homology of the Q32 Equity Value. TD Cowen’s opinion did not in any manner address the value of the Homology CVRs, Homology’s underlying business decision to

 

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effect the Merger or related transactions or the relative merits of the Merger or related transactions as compared to other business strategies or transactions that might be available to Homology. The Q32 Equity Value was determined through negotiations between Homology and Q32 and TD Cowen’s opinion does not constitute a recommendation to any securityholder or any other person as to how to vote or act with respect to the Merger, any related transactions or otherwise.

Interests of Certain Directors and Executive Officers of Homology and Q32 (See pages 174 and 180)

Interests of Homology Directors and Executive Officers in the Merger

In considering the recommendation of the Homology board of directors with respect to issuing shares of Homology common stock in the Merger and the other matters to be acted upon by the Homology stockholders at the Homology Special Meeting, Homology stockholders should be aware that the directors and executive officers of Homology have interests in the Merger that may be different from, or in addition to, the interests of Homology stockholders generally.

Homology is party to an employment agreement with each of Paul Alloway, Ph.D., J.D. and Charles Michaud, Jr., and separation agreements with each of Albert Seymour, Ph.D. and W. Bradford Smith. Under the employment agreements, Dr. Alloway and Mr. Michaud are entitled to a transaction bonus payable upon the completion of the Merger and, if their employment is terminated by Homology without “cause” or by the executive for “good reason,” the executive is entitled to certain severance payments and benefits, including partial payment of the transaction bonus. Under the separation agreements with Dr. Seymour and Mr. Smith, the executive is entitled to certain severance payments and benefits and, if the Merger closes on or before August 16, 2024, payment of a transaction bonus, accelerated vesting of all Homology options and restricted stock units, an extended post-termination exercise period for options and, for Dr. Seymour, additional severance payments and benefits. Such severance payments and benefits provided under the employment agreements and separation agreements are subject to the executive’s execution and non-revocation of a release of claims in favor of Homology and continued compliance with certain restrictive covenants. Homology is also party to a consulting agreement with Mr. Blum, which provides for accelerated vesting of Homology options and restricted stock units if Mr. Blum’s consulting period is terminated other than due to his breach of the consulting agreement or certain restrictive covenants, and an extended post-termination exercise period for his Homology options. Each of the employment agreements, separation agreements and consulting agreement is more fully described below in the section titled “The Merger—Interests of Homology Directors and Executive Officers in the Merger” beginning on page 174 of this proxy statement/prospectus.

Arthur Tzianabos, Ph.D. and Mary Thistle are currently directors of Homology and will continue as directors of the combined company after the Effective Time. Following the Effective Time, it is expected that the combined company will provide compensation to non-employee directors pursuant to a new non-employee director compensation policy that is expected to be adopted post-closing.

As of November 30, 2023, Homology’s non-employee directors and executive officers beneficially owned, in the aggregate, approximately 10.2% of the shares of Homology common stock, excluding any shares of Homology common stock issuable upon exercise or settlement of stock options or restricted stock units or held by such individuals.

The Homology board of directors was aware of and considered these potential conflicts of interest, among other matters, in reaching its decision to approve the Merger Agreement and the Merger, and to recommend that the Homology stockholders approve the proposals to be presented to the stockholders for consideration at the Homology Special Meeting as contemplated in this proxy statement/prospectus. For more information, please see the section titled “The Merger—Interests of Homology Directors and Executive Officers in the Merger” beginning on page 174 of this proxy statement/prospectus.

 

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Interests of Q32 Directors and Executive Officers in the Merger

In considering the recommendation of the Q32 board of directors with respect to approving the Merger, stockholders should be aware that certain members of Q32’s directors and executive officers have interests in the Merger that are different from, or in addition to, the interests of Q32 stockholders generally.

As described elsewhere in this proxy statement/prospectus, including in the section captioned “Management Following the Merger,”                      of Q32’s directors and all of Q32’s executive officers are expected to become the directors and executive officers, respectively, of the combined company upon the closing of the Merger, in connection with which the executive officers may enter into employment agreements comparable to those of applicable executive officers of a publicly traded company. Following completion of the Merger, it is expected that the combined company will provide compensation to non-employee directors pursuant to a new non-employee director compensation policy that is expected to be adopted post-closing, and which will be designed to enable the combined company to attract and retain, on a long-term basis, highly qualified non-employee directors.

As of November 30, 2023, Q32’s non-employee directors and executive officers beneficially owned, in the aggregate, approximately 42.70% of the shares of Q32 capital stock, which for purposes of this subsection excludes any Q32 shares issuable upon exercise of Q32 stock options held by such individuals. Such shares of Q32 capital stock will be converted into shares of Homology common stock at the Effective Time.

These interests may present them with actual or potential conflicts of interest. The board of directors of Q32 was aware of these potential conflicts of interest and considered them, among other matters, in reaching its decision to approve the Merger Agreement and the Merger, and to recommend that the Q32 stockholders approve the Merger as contemplated by this proxy statement/prospectus. For more information, please see the section titled “The Merger—Interests of Q32 Directors and Executive Officers in the Merger” beginning on page 180 of this proxy statement/prospectus.

Overview of the Merger Agreement and Agreements Related to the Merger Agreement

Merger Consideration (see page 187)

At the Effective Time (after giving effect to the Pre-Closing Financing), each share of Q32 common stock (excluding the Q32 common stock issued in the Pre-Closing Financing) will be converted solely into the right to receive a number of shares of Homology common stock equal to the total number of Q32 Merger Shares described in the section titled “The Merger Agreement—Q32 Merger Shares” beginning on page 188 in this proxy statement/prospectus multiplied by the applicable Q32 stockholder’s percentage interest in Q32 as set forth on the Allocation Certificate required under the Merger Agreement. If any Q32 common stock outstanding immediately prior to the Effective Time is unvested or is subject to a repurchase option or a risk of forfeiture under any applicable agreement with Q32, then the shares of Homology common stock issued in exchange for such shares of Q32 common stock will to the same extent be unvested and subject to the same repurchase option or risk of forfeiture, and such shares of Homology common stock will be marked with appropriate legends.

At the Effective Time, by virtue of the Merger, upon the terms and subject to the conditions set forth in the Merger Agreement, each share of Q32 common stock issued in the Pre-Closing Financing will be converted solely into the right to receive a number of shares of Homology common stock equal to the amount of the Pre-Closing Financing Merger Shares described in the section titled “The Merger Agreement—Pre-Closing Financing Merger Shares” beginning on page 189 in this proxy statement/prospectus multiplied by the percentage of the proceeds of the Pre-Closing Financing represented by the applicable stockholder’s investment in the Pre-Closing Financing, as set forth on the Allocation Certificate required under the Merger Agreement.

 

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At the Effective Time, by virtue of the Merger, upon the terms and subject to the conditions set forth in the Merger Agreement, each share of common stock, $0.01 par value per share, of Merger Sub issued and outstanding immediately prior to the Effective Time will be converted into and exchanged for one validly issued, fully paid and nonassessable share of common stock, $0.0001 par value per share, of the combined company.

All Q32 preferred stock will be converted into Q32 common stock as of immediately prior to the Effective Time in accordance with, and pursuant to the terms and conditions of, the organizational documents of Q32.

Treatment of Q32 Options (see page 191)

At the Effective Time, each option to purchase shares of Q32 common stock outstanding as of immediately prior to the Effective Time will automatically be converted into an option to acquire, on the same terms and conditions (including the same vesting and exercisability terms and conditions) the number of shares of Homology common stock equal to the number of shares of Q32 common stock subject to such option as of immediately prior to the Effective Time multiplied by the exchange ratio formula in the Merger Agreement and rounding that result down to the nearest whole number of shares, at a per share exercise price determined by dividing the per share exercise price of such Q32 Option immediately prior to the Effective Time by the exchange ratio formula in the Merger Agreement, rounding up to the nearest whole cent.

Treatment of Q32 Warrants (see page 191)

At the Effective Time, each Q32 Warrant, to the extent outstanding and unexercised, will automatically be converted into a warrant to acquire a number of shares of Homology common stock (each such resulting warrant, is referred to herein as an Assumed Warrant). Each Assumed Warrant shall be subject to the same terms and conditions as were applicable to such corresponding Q32 Warrant immediately prior to the Effective Time (including applicable vesting conditions), except (i) each Assumed Warrant will be exercisable (or will become exercisable in accordance with its terms) for that number of whole shares of Homology common stock equal to the product of the number of shares of Q32 common stock that were issuable upon exercise of such Q32 Warrant immediately prior to the Effective Time multiplied by the exchange ratio formula in the Merger Agreement, rounded down to the nearest whole number of shares of Homology Common Stock, (ii) the per share exercise price for the shares of Homology Common Stock issuable upon exercise of such Assumed Warrant will be equal to the quotient determined by dividing the exercise price per share of Q32 common stock at which such Q32 Warrant was exercisable immediately prior to the Effective Time by the exchange ratio formula in the Merger Agreement, rounded up to the nearest whole cent, and (iii) for terms rendered inoperative by reason of the transactions contemplated by the Merger Agreement.

Treatment of Homology Common Stock, Homology Options and Homology Restricted Stock Units (see page 191) 

Each outstanding unexpired, unexercised and unvested “in-the-money” option of Homology (referred to herein as Homology ITM Options) will vest in full immediately prior to the Effective Time and remain outstanding, subject to proportionate adjustment in accordance with the terms of Homology’s 2018 Incentive Award Plan or 2015 Stock Incentive Plan, as applicable, to reflect the Reverse Stock Split and the issuance of the CVRs, and each option to purchase Homology common stock that is not a Homology ITM Option will be cancelled for no consideration immediately prior to the Effective Time. Each Homology Restricted Stock Unit that is outstanding will vest in full immediately prior to the Effective Time, and the holder of each unsettled Homology Restricted Stock Unit will receive immediately prior to the Effective Time, the number of shares of Homology common stock equal to the number of vested and unsettled shares of Homology common stock underlying such Homology Restricted Stock Unit.

 

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Conditions to the Completion of the Merger (see page 204)

To complete the Merger, Homology stockholders must approve the Stock Issuance Proposal, the Authorized Share Increase Proposal and the Reverse Stock Split Proposal, and Q32 must adopt the Merger Agreement and approve the Merger and the additional transactions contemplated thereby. Additionally, each of the other closing conditions set forth in the Merger Agreement must be satisfied or waived.

Non-Solicitation (see page 198) 

Under the Merger Agreement, each of Homology and Q32 have agreed that neither it nor any of its subsidiaries, directors, officers, employees, agents, attorneys, accountants, investment bankers, advisors or representatives, will directly or indirectly:

 

  •  

solicit, initiate or knowingly encourage, induce or facilitate the communication, making, submission or announcement of any Acquisition Proposal or Acquisition Inquiry or take any action not in the ordinary course of business that could reasonably be expected to lead to an Acquisition Proposal or Acquisition Inquiry;

 

  •  

furnish any non-public information regarding such party to any person (other than Q32 or Homology) in connection with or in response to an Acquisition Proposal or Acquisition Inquiry;

 

  •  

engage in discussions or negotiations with any person with respect to such Acquisition Proposal or Acquisition Inquiry;

 

  •  

approve, endorse or recommend any Acquisition Proposal;

 

  •  

execute or enter into any letter of intent or any contract contemplating or otherwise relating to any Acquisition Transaction; or

 

  •  

publicly proposed to do any of the foregoing.

The Merger Agreement affords Homology certain fiduciary exceptions to the non-solicitation provisions to allow the Homology board of directors to consider a Superior Offer (as defined in the section of this proxy statement/prospectus entitled “The Merger Agreement—Non Solicitation”) under certain circumstances.

Board Recommendation Change (see page 200)

Homology and Q32 agreed (and, with respect to Homology, subject to specified exceptions described in the Merger Agreement and in the section of this proxy statement/prospectus entitled “The Merger Agreement—Board Recommendation Change” beginning on page 200) that their boards of directors may not take any of the following actions:

 

  •  

withhold, amend, withdraw or modify (or publicly propose to withhold, amend, withdraw or modify) the recommendation of their boards of directors in a manner adverse to the other party;

 

  •  

resolve, or have any committee of their boards of directors resolve, to withdraw or modify their recommendation in a manner adverse to the other party; or

 

  •  

adopt, approve or recommend (or publicly propose to adopt, approve or recommend) any Acquisition Proposal.

Termination of the Merger Agreement (see page 205)

Either Homology or Q32 may terminate the Merger Agreement under certain circumstances, which would prevent the Merger from being consummated.

 

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Termination Fee (see page 205)

If the Merger Agreement is terminated under certain circumstances, either Homology could be required to pay Q32 a termination fee of $2.4 million, or Q32 could be required to pay Homology a termination fee of $5.85 million.

Support Agreements (see page 209)

Certain Q32 stockholders are party to support agreements with Homology pursuant to which, among other things, each such stockholder has agreed, solely in his, her or its capacity as a Q32 stockholder, to vote all of his, her or its shares of Q32 capital stock in favor of (i) the adoption of the Merger Agreement and approval of the Merger, (ii) the approval of the related transactions contemplated by the Merger Agreement, (iii) the conversion of each share of Q32 preferred stock into shares of Q32 common stock immediately prior to and contingent upon the closing and (iv) the approval of certain additional proposals in connection with the Merger that the Q32 board of directors may recommend. These Q32 stockholders also agreed to vote against (i) any competing Acquisition Proposal (as defined in the section of this proxy statement/prospectus entitled “The Merger Agreement—Non-Solicitation” beginning on page 198) and (ii) any action, proposal, agreement, transaction or proposed transaction that would reasonably be expected to materially impede, interfere with, delay, postpone, discourage or adversely affect the Merger or any of the other transactions contemplated by the Merger Agreement, subject to certain specified exceptions.

As of November 16, 2023, the Q32 stockholders that are party to support agreements with Homology owned an aggregate of 1,693,680 shares of Q32 common stock and 84,305,730 shares of Q32 preferred stock, representing approximately 74.1% of the outstanding shares of Q32 common stock and Q32 preferred stock. These stockholders include executive officers and directors of Q32, as well as certain other stockholders owning a significant portion of the outstanding shares of Q32 capital stock. Following the effectiveness of the registration statement on Form S-4 of which this proxy statement/prospectus is a part and pursuant to the Merger Agreement, Q32 stockholders holding a sufficient number of shares of Q32 capital stock to adopt the Merger Agreement and approve the Merger and related transactions will execute written consents providing for such adoption and approval.

Certain Homology stockholders have entered into support agreements with Q32 pursuant to which, among other things, each such stockholder has agreed, solely in his, her or its capacity as a Homology stockholder, to vote all of his, her or its shares of Homology common stock in favor of (i) the approval of the Merger Agreement, (ii) the transactions contemplated thereby, including the issuance of Homology common stock to Q32 stockholders, (iii) an amendment to the restated certificate of incorporation of Homology to effect the proposed Reverse Stock Split, (iv) any proposal to adjourn or postpone the meeting to a later date, if there are not sufficient votes for the approval of the Merger Agreement and the transactions contemplated therein and (v) the approval of certain additional proposals in connection with the Merger that the Homology board of directors may recommend. These Homology stockholders also agreed to vote against (i) any action or agreement that would result in a breach of any representation, warranty, covenant or obligation of Homology in the Merger Agreement, (ii) any competing Acquisition Proposal (as defined in the section of this proxy statement/prospectus entitled “The Merger Agreement—Non-Solicitation” beginning on page 198) with respect to Homology and (iii) any action, proposal, agreement, transaction or proposed transaction that would reasonably be expected to materially impede, interfere with, delay, postpone, discourage or adversely affect the Merger or any of the other transactions contemplated by the Merger Agreement, subject to certain specified exceptions.

As of November 30, 2023, the Homology stockholders that are party to a support agreement owned approximately 18.3% of the outstanding shares of Homology common stock. These stockholders include certain executive officers and directors of Homology.

 

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Lock-Up Agreements (see page 210) 

Certain of Q32’s executive officers, directors and stockholders have entered into lock-up agreements, pursuant to which such parties have agreed not to, except in limited circumstances, offer, pledge, sell, contract to sell, sell any option to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, any shares of Homology’s common stock, including, as applicable, shares received in the Merger and shares issuable upon exercise of options, warrants or convertible securities, until 180 days after the Effective Time.

The Q32 stockholders who have executed lock-up agreements as of November 16, 2023, owned in the aggregate, approximately 74.1% of the outstanding shares of Q32 common stock and Q32 preferred stock.

Certain of Homology’s directors have entered into lock-up agreements, pursuant to which such stockholders have agreed not to, except in limited circumstances, offer, pledge, sell, contract to sell, sell any option to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, any Homology securities or shares of Homology common stock, including, as applicable, shares issuable upon exercise of certain options, warrants or convertible securities, until 180 days after the Effective Time.

Homology stockholders who have executed lock-up agreements as of November 30, 2023 owned, in the aggregate, less than 1% of the shares of outstanding Homology common stock.

The Q32 Pre-Closing Financing (see page 211)

On November 16, 2023, concurrently with the execution and delivery of the Merger Agreement, Q32 entered into a subscription agreement, or the Subscription Agreement, with certain accredited investors pursuant to which such investors agreed to purchase shares of Q32 common stock for aggregate gross proceeds of approximately $42.0 million to Q32, which private placement is referred to herein as the Pre-Closing Financing. The closing of the Pre-Closing Financing is conditioned upon the satisfaction or waiver of the conditions to the closing of the Merger as well as certain other conditions. Immediately after the Merger, the shares of Q32 common stock issued in the Pre-Closing Financing are expected to represent approximately 13.2% of the outstanding shares of the combined company. Q32 and the investors participating in the Pre-Closing Financing have also agreed to enter into the registration rights agreement at the closing of the Pre-Closing Financing, pursuant to which, among other things, the combined company will agree to provide for registration rights for certain shares of the combined company’s common stock that are held by the investors participating in the Pre-Closing Financing from time to time.

Contingent Value Rights Agreement (see page 211)

Prior to the Effective Time, Homology and Equiniti Trust Company, LLC, as Rights Agent, will enter into the CVR Agreement pursuant to which Homology stockholders of record as of the close of business on the last business day prior to the day on which the Effective Time occurs will receive one CVR for each outstanding share of Homology common stock held by such stockholder on such date. A copy of the form of CVR Agreement is included as Annex D to this proxy statement/prospectus.

Each CVR will represent the contractual right to receive payments from Homology upon the actual receipt by Homology or its subsidiaries of certain contingent proceeds derived from any cash consideration that is paid to Homology or its subsidiaries as a result of the sale, transfer, license, assignment or other divestiture, disposition or commercialization of the following (referred to herein as the Legacy Assets, and such disposition, a Legacy Asset Disposition): any of Homology’s assets, rights and interests relating to Homology’s HMI-103

 

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product candidate (Adult/Pediatric PKU), HMI-204 product candidate (MLD) and Homology’s Capsids and AAVHSC Platform, including any equity interests held directly or indirectly by Homology in Oxford Biomedica Solutions LLC or its affiliates, referred to herein as OXB Solutions, pursuant to that certain Equity Securities Purchase Agreement, dated as of January 28, 2022, by and between Homology and OXB Solutions, in which Homology currently owns 20% of the fully diluted equity interests in OXB Solutions and Homology is entitled to exercise a put option to sell or transfer Homology’s equity interests in OXB Solutions set forth therein on March 10, 2025; such interests are referred to herein as the Oxford Assets. Payments of the proceeds from a Legacy Asset Disposition will be net of certain taxes, transaction costs and certain other expenses.

The contingent payments under the CVR Agreement, if they become payable, will become payable to the Rights Agent for subsequent distribution to the holders of the CVRs. In the event there is no Legacy Asset Disposition (other than with respect to the Oxford Assets) prior to the 18-month anniversary of the closing of the Merger, holders will not receive any payments pursuant to the CVR Agreement with respect to the Legacy Assets (other than possibly the Oxford Assets). If no disposition of the Oxford Assets occurs prior to the 24-month anniversary of the closing of the Merger, holders will not receive any payments pursuant to the CVR Agreement with respect to the Oxford Assets. There can be no assurance than any Legacy Asset Disposition (including the disposition of Oxford Assets) will occur or that any holders of CVRs will receive payments with respect thereto.

The right to the contingent payments contemplated by the CVR Agreement is a contractual right only and will not be transferable, except in the limited circumstances specified in the CVR Agreement. The CVRs will not be evidenced by a certificate or any other instrument and will not be registered with the SEC. The CVRs will not have any voting or dividend rights and will not represent any equity or ownership interest in Homology or the combined company or any of its subsidiaries. No interest will accrue on any amounts payable in respect of the CVRs.

Management Following the Merger (See page 388)

Effective as of the closing of the Merger, the combined company’s executive officers are expected to be members of the Q32 executive management team prior to the Merger, including:

 

Name

  

Title

Jodie Morrison

  

President and Chief Executive Officer

Lee Kalowski.

  

Interim Chief Financial Officer

Shelia Violette, Ph.D.

  

Founder & Chief Scientific Officer

Jason Campagna, M.D., Ph.D.

  

Chief Medical Officer

Material U.S. Federal Income Tax Consequences of the Merger (See page 220)

Homology and Q32 intend the Merger to qualify as a “reorganization” within the meaning of Section 368(a) of the Code and the applicable United States Treasury regulations thereunder and the Merger Agreement to constitute a “plan of reorganization” within the meaning of Section 368 and Treasury Regulations Section 1.368-2(g). Assuming the Merger qualifies as a “reorganization” within the meaning of Section 368(a) of the Code, subject to the limitations and qualifications described in the section titled “Material U.S. Federal Income Tax Consequences of the Merger,” holders of Q32 common stock that exchange their Q32 common stock for Homology common stock in the Merger generally should not recognize gain or loss for U.S. federal income tax purposes on such exchange. However, if the Merger does not qualify as a “reorganization” within the meaning of Section 368(a) of the Code, the Merger would be a taxable transaction to U.S. Holders (as defined in the section titled “Material U.S. Federal Income Tax Consequences of the Merger”), but Non-U.S. Holders (as defined in the section titled “Material U.S. Federal Income Tax Consequences of the Merger”) generally would not be subject to U.S. federal income tax on any gain realized in connection with the Merger. The closing of the Merger is not conditioned upon the receipt of an opinion of counsel or a ruling from the IRS regarding the U.S.

 

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federal income tax treatment of the Merger, and no opinion of counsel or ruling from the IRS will be requested regarding such treatment. Accordingly, there can be no assurance that the IRS will not challenge the qualification of the Merger as a “reorganization” within the meaning of Section 368(a) of the Code or that a court will not sustain such a challenge by the IRS.

The tax consequences to you of the Merger will depend on your particular facts and circumstances. Please consult your tax advisor as to the tax consequences of the Merger in your particular circumstances, including the applicability and effect of U.S. federal, state, local and foreign income and other tax laws. For a more detailed discussion of the material U.S. federal income tax consequences of the Merger, see “Material U.S. Federal Income Tax Consequences of the Merger” beginning on page 220.

Nasdaq Stock Market Listing (See page 183)

Q32 intends to file an initial listing application for the combined company common stock with the Nasdaq Stock Market LLC. If such application is accepted, Homology anticipates that the common stock of the combined company will be listed on Nasdaq following the closing of the Merger under the trading symbol “QTTB.”

Anticipated Accounting Treatment (See page 183)

The Merger is expected to be treated by Homology as a reverse merger and will be accounted for as a reverse recapitalization in accordance with United States Generally Accepted Accounting Principles, or U.S. GAAP. For accounting purposes, Q32 is considered to be acquiring the assets and liabilities of Homology in this transaction based on the terms of the Merger Agreement and other factors, including: (i) Q32’s stockholders will own a substantial majority of the voting rights of the combined company; (ii) Q32 will designate a majority (seven of nine) of the initial members of the board of directors of the combined company; (iii) Q32’s executive management team will become the management of the combined company; and (iv) the combined company will be named Q32 Bio Inc. and be headquartered in Waltham, Massachusetts. Accordingly the Merger is expected to be treated as the equivalent of Q32 issuing stock for primarily cash and cash equivalents, short-term investments and non-operating assets. The net assets of Homology will be recorded as of the acquisition date in the financial statements of Q32 and the reported operating results prior to the Merger will be those of Q32. See “Unaudited Pro Forma Condensed Combined Financial Statements” included elsewhere in this proxy statement/prospectus for additional information.

Appraisal Rights and Dissenters’ Rights (See page 183)

Stockholders of Homology common stock are not entitled to appraisal rights in connection with the Merger under Delaware law. Stockholders of Q32 common stock are entitled to appraisal rights in connection with the Merger under Delaware law.

Comparison of Stockholder Rights (See page 430)

Both Homology and Q32 are incorporated under the laws of the State of Delaware and, accordingly, the rights of the stockholders of each are currently, and will continue to be, governed by the Delaware General Corporation Law, or the DGCL. If the Merger is completed, Q32 stockholders will become Homology stockholders, and their rights will be governed by the DGCL, the Amended and Restated Bylaws of Homology and the Restated Certificate of Incorporation of Homology, as may be amended by the Authorized Share Increase Proposal and the Reverse Stock Split Proposal if approved by the Homology stockholders at the Homology Special Meeting. The rights of Homology stockholders contained in the Restated Certificate of Incorporation, as amended, and Amended and Restated Bylaws of Homology differ from the rights of Q32 stockholders under the Second Amended and Restated Certificate of Incorporation and Bylaws of Q32, as more fully described under the section titled “Comparison of Rights of Holders of Homology Capital Stock and Q32 Capital Stock” beginning on page 430 of this proxy statement/prospectus.

 

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Risk Factors (See page 29)

Both Homology and Q32 are subject to various risks associated with their businesses and their industries. In addition, the Merger, including the possibility that the Merger may not be completed, poses a number of risks to each company and its respective securityholders, including the following risks:

Risks Related to the Merger

 

  •  

The exchange ratio will not be adjusted based on the market price of Homology common stock so the merger consideration at the closing may have a greater or lesser value than at the time the Merger Agreement was signed.

 

  •  

Failure to complete the Merger may result in Homology or Q32 paying a termination fee to the other party, which could harm the Homology common stock price and the future business and operations of each company.

 

  •  

Some Homology and Q32 executive officers and directors have interests in the Merger that are different from yours and that may influence them to support or approve the Merger without regard to your interests.

 

  •  

Homology stockholders and Q32 stockholders may not realize a benefit from the Merger commensurate with the ownership dilution they will experience in connection with the Merger.

 

  •  

If the conditions to the Merger are not satisfied or waived, the Merger may not occur.

 

  •  

If the Merger is not completed, Homology’s stock price may decline significantly.

Risks Related to Homology

 

  •  

Failure to complete, or delays in completing, the proposed Merger with Q32 could expose Homology to other operational and financial risks.

 

  •  

Homology stockholders may not receive any payment on the CVRs, and the CVRs may expire valueless.

 

  •  

Homology’s stockholders may not realize a benefit from the Merger commensurate with the ownership dilution they will experience in connection with the Merger.

 

  •  

Homology has a limited operating history, no history of commercializing products, has incurred significant losses since inception and anticipates continuing to incur net losses for the foreseeable future.

 

  •  

If the Merger is not consummated and should Homology resume development of product candidates, it will require additional capital to fund its operations.

 

  •  

If Homology fails to obtain necessary financing, it will not be able to complete the development and commercialization of such product candidates.

 

  •  

Homology’s failure to meet Nasdaq’s continued listing requirements could result in a delisting of its common stock.

Risks Related to Q32

 

  •  

Q32 has incurred significant losses since inception, expects to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future. Q32 has no products for sale, has not generated any product revenue and may never generate product revenue or become profitable.

 

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  •  

Even if the Merger and Q32’s Pre-Closing Financing are successful, Q32 will require substantial additional capital to finance its operations in the future. If Q32 is unable to raise such capital when needed, or on acceptable terms, Q32 may be forced to delay, reduce or eliminate clinical trials, product development programs or future commercialization efforts.

 

  •  

Q32 has a limited operating history and has no products approved for commercial sale, which may make it difficult for you to evaluate its current business and likelihood of success and viability.

 

  •  

Q32 faces competition from entities that have developed or may develop programs for the diseases it plans to address with bempikibart, ADX-097 or other product candidates.

 

  •  

Bempikibart, ADX-097 and Q32’s pipeline are in early stages of development and may fail in development or suffer delays that materially and adversely affect their commercial viability. If Q32 or its current or future collaborators are unable to complete development of, or commercialize, Q32’s product candidates, or experience significant delays in doing so, its business will be materially harmed.

 

  •  

Q32 is substantially dependent on the success of its most advanced product candidates, bempikibart and ADX-097, and its clinical trials of such candidates may not be successful.

 

  •  

Q32’s business relies on certain licensing rights from BMS that can be terminated in certain circumstances. If Q32 breaches the BMS License Agreement, or if we are unable to satisfy our obligations under which we license intellectual property from BMS, we could lose the ability to develop and commercialize bempikibart.

 

  •  

Q32’s ability to protect its patents and other proprietary rights is uncertain, exposing it to the possible loss of competitive advantage.

 

  •  

Q32 and its independent registered public accounting firm have identified a material weakness in its internal control over financial reporting. If Q32 is unable to remediate this material weakness, or if it identifies additional material weaknesses in the future or otherwise fail to maintain an effective system of internal controls, it may not be able to accurately or timely report its financial condition or results of operations, which may adversely affect its business and the market price of the combined company’s common stock.

Risks Related to the Combined Company

 

  •  

The market price of the combined company’s common stock is expected to be volatile, and the market price of the common stock may drop following the Merger.

 

  •  

The combined company may incur losses for the foreseeable future and might never achieve profitability.

 

  •  

Following the Merger, the combined company may be unable to integrate successfully the businesses of Homology and Q32 and realize the anticipated benefits of the Merger.

 

  •  

If the combined company fails to attract and retain management and other key personnel, it may be unable to continue to successfully develop or commercialize its product candidates or otherwise implement its business plan.

 

  •  

The combined company will need to raise additional financing in the future to fund its operations, which may not be available to it on favorable terms or at all.

 

  •  

Upon completion of the Merger, failure by the combined company to comply with the initial listing standards of Nasdaq will prevent its stock from being listed on Nasdaq.

These risks and other risks are discussed in greater detail under the section titled “Risk Factors” beginning on page 29 of this proxy statement/prospectus. Homology and Q32 both encourage you to read and consider all of these risks carefully.

 

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MARKET PRICE AND DIVIDEND INFORMATION

Shares of Homology common stock are currently listed on Nasdaq under the symbol “FIXX.” The closing price of Homology common stock on November 15, 2023, the last trading day prior to the public announcement of the Merger, was $0.88 per share, as reported on Nasdaq. The closing price of the Homology common stock on                 , 2024, as reported on Nasdaq, was $                 per share.

Because the market price of Homology common stock is subject to fluctuation, the market value of the shares of Homology common stock that Q32 stockholders will be entitled to receive in the Merger may increase or decrease.

Q32 is a private company, and its shares of common stock and preferred stock are not publicly traded.

Assuming approval of the Stock Issuance Proposal, the Authorized Share Increase Proposal and the Reverse Stock Split Proposal, and successful application for initial listing with Nasdaq, following the consummation of the Merger, the Homology common stock will trade on Nasdaq under Homology’s new name, “Q32 Bio Inc.,” and new trading symbol “QTTB.”

As of         , 2024, the Record Date for the Homology Special Meeting, there were approximately holders of record of the Homology common stock. As of         , 2024, Q32 had holders of record of Q32 common stock and holders of record of Q32 preferred stock. For detailed information regarding the beneficial ownership of certain Homology and Q32 stockholders, see the sections of this proxy statement/prospectus titled “Principal Stockholders of Homology” and “Principal Stockholders of Q32.”

Dividends

Homology has never declared or paid cash dividends on its capital stock. Q32 has never paid or declared any cash dividends on its capital stock. Q32 intends to retain all available funds and any future earnings for use in the operation of its business and does not anticipate paying any cash dividends on its capital stock in the foreseeable future. Notwithstanding the foregoing, any determination to pay cash dividends subsequent to the Merger will be at the discretion of the combined company’s board of directors and will depend upon a number of factors, including the combined company’s results of operations, financial condition, future prospects, contractual restrictions, restrictions imposed by applicable law and other factors the combined company’s board of directors deems relevant.

 

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RISK FACTORS

The combined company will be faced with a market environment that cannot be predicted and that involves significant risks, many of which will be beyond its control. In addition to the other information contained in this proxy statement/prospectus, you should carefully consider the material risks described below before deciding how to vote your shares of Homology common stock. You should also read and consider the other information in this proxy statement/prospectus.

Risks Related to the Merger

The exchange ratio will not be adjusted based on the market price of Homology common stock so the merger consideration at the closing may have a greater or lesser value than at the time the Merger Agreement was signed.

At the Effective Time, outstanding shares of Q32 common stock (after giving effect to the conversion of each share of Q32’s preferred stock into Q32 common stock and the conversion of the Q32 Convertible Notes into Q32 common stock and including all such shares that are converted into Q32 common stock) will be converted into shares of Homology common stock. Immediately after the Merger, Homology securityholders as of immediately prior to the Merger are expected to own approximately 25% of the outstanding shares of the combined company on a fully-diluted basis and former Q32 securityholders (including purchasers in the Pre-Closing Financing) are expected to own approximately 75% of the outstanding shares of the combined company on a fully-diluted basis, subject to certain assumptions, including, but not limited to, Homology’s net cash as of closing being equal to $60.0 million and Q32 issuing $42.0 million of Q32 common stock in the Pre-Closing Financing described elsewhere in this proxy statement/prospectus. Under certain circumstances further described in the Merger Agreement, the ownership percentages may be adjusted up or down including, but not limited to, if Homology’s net cash as of closing is lower than $59.5 million or greater than $60.5 million.

Any changes in the market price of Homology common stock before the completion of the Merger will not affect the number of shares Q32 stockholders will be entitled to receive pursuant to the Merger Agreement. Therefore, if before the completion of the Merger, the market price of Homology common stock increases from the market price on the date of the Merger Agreement, then Q32 stockholders could receive merger consideration with substantially more value for their shares of Q32 common stock than the parties had negotiated when they established the exchange ratio. Similarly, if before the completion of the Merger the market price of Homology common stock declines from the market price on the date of the Merger Agreement, then Q32 stockholders could receive merger consideration with substantially lower value. The Merger Agreement does not include a price-based termination right.

Failure to complete the Merger may result in Homology paying a termination fee to Q32, which could harm the Homology common stock price and future business and operations of Homology.

If the Merger is not completed, Homology is subject to the following risks:

 

  •  

if the Merger Agreement is terminated under specified circumstances, Homology may be required to pay Q32 a termination fee of $2.4 million;

 

  •  

the price of Homology common stock may decline and could fluctuate significantly; and

 

  •  

costs related to the Merger, such as financial advisor, legal and accounting fees, which Homology estimates will total approximately $                , which must be paid even if the Merger is not completed.

If the Merger Agreement is terminated and the board of directors of Homology determines to seek another business combination, there can be no assurance that Homology will be able to find a partner with whom a business combination would yield greater benefits than the benefits to be provided under the Merger Agreement.

 

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If the conditions to the Merger are not satisfied or waived, the Merger may not occur.

Even if the Merger is approved by the stockholders of Q32 and the Stock Issuance Proposal is approved by the Homology stockholders, specified conditions must be satisfied or waived to complete the Merger. These conditions are set forth in the Merger Agreement and described in the section titled “The Merger Agreement—Conditions to the Completion of the Merger” in this proxy statement/prospectus. Homology and Q32 cannot assure you that all of the conditions to the consummation of the Merger will be satisfied or waived. If the conditions are not satisfied or waived, the Merger may not occur or the closing may be delayed, and Homology and Q32 each may lose some or all of the intended benefits of the Merger.

The Merger may be completed even though a material adverse effect may result from the announcement of the Merger, industry-wide changes or other causes.

In general, neither Homology nor Q32 is obligated to complete the Merger if there is a material adverse effect affecting the other party between November 16, 2023, the date of the Merger Agreement, and the closing of the Merger. However, certain types of changes are excluded from the concept of a “material adverse effect.” Such exclusions include but are not limited to changes in general economic or political conditions, changes resulting from the announcement of the Merger, natural disasters, pandemics, other force majeure events, acts or threats of terrorism or war and changes in GAAP. Therefore, if any of these events were to occur impacting Homology or Q32, the other party would still be obliged to consummate the closing of the Merger. If any such adverse changes occur and Homology and Q32 consummate the closing of the Merger, the stock price of the combined company may suffer. This in turn may reduce the value of the Merger to the stockholders of Homology, Q32 or both. For a more complete discussion of what constitutes a material adverse effect on Homology or Q32, see the section titled “The Merger Agreement—Representations and Warranties” in this proxy statement/prospectus.

If Homology and Q32 complete the Merger, the combined company will need to raise additional capital by issuing equity securities or additional debt or through licensing arrangements, which may cause significant dilution to the combined company’s stockholders or restrict the combined company’s operations.

Additional financing may not be available to the combined company when it is needed or may not be available on favorable terms. To the extent that the combined company raises additional capital by issuing equity securities, such financing will cause additional dilution to all securityholders of the combined company, including Homology’s pre-Merger stockholders and Q32’s former securityholders. It is also possible that the terms of any new equity securities may have preferences over the combined company’s common stock. Any debt financing the combined company enters into may involve covenants that restrict its operations. These restrictive covenants may include limitations on additional borrowing and specific restrictions on the use of the combined company’s assets, as well as prohibitions on its ability to create liens, pay dividends, redeem its stock or make investments. In addition, if the combined company raises additional funds through licensing arrangements, it may be necessary to grant licenses on terms that are not favorable to the combined company.

Some Homology and Q32 directors and executive officers have interests in the Merger that are different from yours and that may influence them to support or approve the Merger without regard to your interests.

Directors and executive officers of Homology and Q32 may have interests in the Merger that are different from, or in addition to, the interests of other Homology stockholders generally. These interests with respect to Homology’s directors and executive officers may include, among others, acceleration of Homology ITM Options, Homology Restricted Stock Units, transaction bonus payments, severance payments and benefits if employment is terminated in a qualifying termination in connection with the Merger and rights to continued indemnification, expense advancement and insurance coverage. Arthur Tzianabos, Ph.D. and Mary Thistle, current members of the Homology board of directors will continue as directors of the combined company after the Effective Time. Following the Effective Time, it is expected that the combined company will provide

 

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compensation to non-employee directors pursuant to a new non-employee director compensation policy that is expected to be adopted post-closing. These interests with respect to Q32’s directors and executive officers may include, among others, certain of Q32’s directors and executive officers have options, subject to vesting, to purchase shares of Q32 common stock which, after the Effective Time, will be converted into and become options to purchase shares of the common stock of the combined company; Q32’s executive officers are expected to continue as executive officers of the combined company after the Effective Time; and all of Q32’s directors and executive officers are entitled to certain indemnification and liability insurance coverage pursuant to the terms of the Merger Agreement. Further, certain current members of Q32’s board of directors will continue as directors of the combined company after the Effective Time, and, following the Effective Time, it is expected that the combined company will provide compensation to non-employee directors pursuant to a new non-employee director compensation policy that is expected to be adopted post-closing.

The board of directors of both Homology and Q32 were aware of and considered these interests, among other matters, in reaching their decisions to approve and adopt the Merger Agreement, approve the Merger, approve the issuance of Homology common stock in the Merger, and recommend the approval of the Merger Agreement to Q32 stockholders and the issuance of the Homology common stock to Q32 stockholders in the Merger to the Homology stockholders. These interests, among other factors, may have influenced the directors and executive officers of Homology and Q32 to support or approve the Merger.

For more information regarding the interests of Homology and Q32 directors and executive officers in the Merger, please see the sections titled “The Merger—Interests of Homology Directors and Executive Officers in the Merger” and “The Merger—Interests of Q32 Directors and Executive Officers in the Merger” in this proxy statement/prospectus.

Homology stockholders may not realize a benefit from the Merger commensurate with the ownership dilution they will experience in connection with the Merger.

If the combined company is unable to realize the full strategic and financial benefits currently anticipated from the Merger, Homology stockholders will have experienced substantial dilution of their ownership interests without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the extent the combined company is able to realize only part of the strategic and financial benefits currently anticipated from the Merger.

If the Merger is not completed, Homology’s stock price may decline significantly.

The market price of Homology common stock is subject to significant fluctuations. During the 12-month period ended September 30, 2023, the closing sales price of Homology common stock on Nasdaq ranged from a high of $2.04 on November 16, 2022 to a low of $ 0.83 on June 28, 2023. Market prices for securities of pharmaceutical, biotechnology and other life science companies have historically been particularly volatile. In addition, the market price of Homology common stock will likely be volatile based on whether stockholders and other investors believe that Homology can complete the Merger or otherwise raise additional capital to support Homology’s operations if the Merger is not consummated and another strategic transaction cannot be identified, negotiated and consummated in a timely manner, if at all. The volatility of the market price of Homology common stock is exacerbated by low trading volume. Additional factors that may cause the market price of Homology common stock to fluctuate include:

 

  •  

adverse publicity relating to the combined company’s business and product candidates;

 

  •  

the loss of key employees;

 

  •  

future sales of common stock;

 

  •  

general and industry-specific economic conditions;

 

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  •  

the failure to meet industry analyst expectations; and

 

  •  

period-to-period fluctuations in financial results.

See also “Risks related to Homology common stock—The market price of Homology common stock has been volatile and fluctuated and may in future fluctuate substantially, which could result in substantial losses for Homology’s stockholders”. Moreover, the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market fluctuations may also adversely affect the trading price of Homology common stock. In the past, following periods of volatility in the market price of a company’s securities, stockholders have often instituted class action securities litigation against such companies.

Homology and Q32 securityholders will have a reduced ownership and voting interest in, and will exercise less influence over the management of, the combined company following the completion of the Merger as compared to their current ownership and voting interests in the respective companies.

After the completion of the Merger, the current stockholders of Homology and Q32 will own a smaller percentage of the combined company than their ownership of their respective companies prior to the Merger. Immediately after the Merger, Homology securityholders as of immediately prior to the Merger are expected to own approximately 25% of the outstanding shares of the combined company on a fully-diluted basis and former Q32 securityholders (including purchasers in the Pre-Closing Financing) are expected to own approximately 75% of the outstanding shares of the combined company on a fully-diluted basis, subject to certain assumptions, including, but not limited to, Homology’s net cash as of closing being equal to $60.0 million and Q32 issuing approximately $42.0 million of Q32 common stock in the Pre-Closing Financing described elsewhere in this proxy statement/prospectus. Under certain circumstances further described in the Merger Agreement, the ownership percentages may be adjusted up or down including, but not limited to, if Homology’s net cash as of closing is lower than $59.5 million or greater than $60.5 million.

During the pendency of the Merger, Homology and Q32 may not be able to enter into a business combination with another party on more favorable terms because of restrictions in the Merger Agreement, which could adversely affect their respective business prospects.

Covenants in the Merger Agreement impede the ability of Homology and Q32 to make acquisitions during the pendency of the Merger, subject to specified exceptions. As a result, if the Merger is not completed, the parties may be at a disadvantage to their competitors during that period. In addition, while the Merger Agreement is in effect, each party is generally prohibited from soliciting, proposing, seeking or knowingly encouraging, facilitating or supporting any inquiries, indications of interest, proposals or offers that constitute or may reasonably be expected to lead to certain transactions involving a third party, including a merger, sale of assets or other business combination, subject to specified exceptions. Any such transactions could be favorable to such party’s stockholders, but the parties may be unable to pursue them. For more information, see the section titled “The Merger Agreement—Non-Solicitation” this proxy statement/prospectus.

Certain provisions of the Merger Agreement may discourage third parties from submitting competing proposals, including proposals that may be superior to the transactions contemplated by the Merger Agreement.

The terms of the Merger Agreement prohibit each of Homology and Q32 from soliciting competing proposals or cooperating with persons making unsolicited takeover proposals, except in limited circumstances as described in further detail in the section titled “The Merger Agreement—Non-Solicitation” in this proxy statement/prospectus. In addition, if Homology terminates the Merger Agreement under specified circumstances, Homology may be required to pay Q32 a termination fee of $2.4 million. This termination fee may discourage third parties from submitting competing proposals to Homology or its stockholders, and may cause the Homology board of directors to be less inclined to recommend a competing proposal.

 

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Because the lack of a public market for Q32’s stock makes it difficult to evaluate the fair market value of Q32’s stock, Homology may pay more than the fair market value of Q32’s stock and/or the stockholders of Q32 may receive consideration in the Merger that is less than the fair market value of Q32’s stock.

The outstanding Q32 common stock is privately held and is not traded in any public market. The lack of a public market makes it difficult to determine the fair market value of Q32’s stock. Because the percentage of Homology equity to be issued to Q32 stockholders was determined based on negotiations between the parties, it is possible that the value of the Homology common stock to be received by Q32 stockholders will be less than the fair market value of Q32’s stock, or Homology may pay more than the aggregate fair market value for Q32’s stock.

Homology stockholders may not receive any payment on the CVRs, and the CVRs may expire valueless.

The right of Homology stockholders to receive any future payment on or derive any value from the CVRs will be contingent solely upon the occurrence of the Legacy Asset Dispositions within the time periods specified in the CVR Agreement and the consideration received being greater than the amounts permitted to be withheld or deducted by Homology under the CVR Agreement. There is no guarantee that Homology will be able to successfully collaborate or sell any of these assets or establish a viable entity to manage the development of these assets. In the event that no Legacy Asset Dispositions occur within the time periods specified in the CVR Agreement, no payments will be made under the CVR Agreement, and the CVRs will expire valueless.

Furthermore, the CVRs will be unsecured obligations of the combined company and all payments under the CVRs, all other obligations under the CVR Agreement and the CVRs and any rights or claims relating thereto may be subordinated in right of payment to the prior payment in full of all current or future senior obligations of the combined company.

The tax treatment of the CVRs is unclear.

The U.S. federal income tax treatment of the CVRs is unclear. There is no legal authority directly addressing the U.S. federal income tax treatment of the receipt of, holding of or payments under, the CVRs, and there can be no assurance that the IRS would not assert, or that a court would not sustain, a position that could result in adverse U.S. federal income tax consequences to holders of the CVRs.

For example, as discussed in the section titled “Agreements Related to the Merger—Contingent Value Rights Agreement—Material U.S. Federal Income Tax Consequences of the CVRs to Holders of Homology Common Stock” in this proxy statement/prospectus, Homology does not intend to report the issuance of the CVRs as a current distribution of property with respect to its stock, but it is possible that the IRS could assert that Homology stockholders are treated as having received a distribution of property equal to the fair market value of the CVRs on the date the CVRs are distributed, which could be taxable to Homology stockholders without the corresponding receipt of cash. In addition, it is possible that the IRS or a court could determine that the issuance of the CVRs (and/or any payments thereon) and the Reverse Stock Split constitute a single “recapitalization” for U.S. federal income tax purposes with the CVRs constituting taxable “boot” received in such recapitalization exchange. In such case, the tax consequences of the CVRs and the Reverse Stock Split would differ from those described in this proxy statement/prospectus, including with respect to the timing and character of income.

Risks Related to the Proposed Reverse Stock Split

The Reverse Stock Split may not increase the combined company’s stock price over the long-term.

The principal purpose of the Reverse Stock Split is to (i) increase the per-share market price of Homology common stock above the minimum bid price requirement under the Nasdaq rules so that Homology can maintain its listing on Nasdaq and (ii) increase the number of theorized and unissued shares available for future issuance in connection with the merger. It cannot be assured, however, that the Reverse Stock Split will accomplish this objective for any meaningful period of time. While it is expected that the reduction in the number of outstanding shares of

 

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common stock will proportionally increase the market price of Homology common stock, it cannot be assured that the Reverse Stock Split will increase the market price of its common stock by enough to maintain the listing of Homology common stock on Nasdaq, or result in any permanent or sustained increase in the market price of Homology common stock, which is dependent upon many factors, including Homology’s business and financial performance, general market conditions, and prospects for future success. Thus, while the stock price of Homology might meet the continued listing requirements for Nasdaq initially, it cannot be assured that it will continue to do so.

The Reverse Stock Split may decrease the liquidity of the combined company’s common stock.

Although the Homology board of directors believes that the anticipated increase in the market price of the combined company’s common stock resulting from the proposed Reverse Stock Split could encourage interest in its common stock and possibly promote greater liquidity for its stockholders, such liquidity could also be adversely affected by the reduced number of shares outstanding after the Reverse Stock Split. The reduction in the number of outstanding shares may lead to reduced trading and a smaller number of market makers for the combined company’s common stock. In addition, the Reverse Stock Split may not result in an increase in the combined company’s stock price necessary to satisfy Nasdaq’s initial listing requirements for the combined company.

The Reverse Stock Split may lead to a decrease in the combined company’s overall market capitalization.

Should the market price of the combined company’s common stock decline after the Reverse Stock Split, the percentage decline may be greater, due to the smaller number of shares outstanding, than it would have been prior to the Reverse Stock Split. A Reverse Stock Split is often viewed negatively by the market and, consequently, can lead to a decrease in the combined company’s overall market capitalization. If the per share market price does not increase in proportion to the Reverse Stock Split ratio, then the value of the combined company, as measured by its stock capitalization, will be reduced. In some cases, the per-share stock price of companies that have effected reverse stock splits subsequently declined back to pre-reverse split levels, and accordingly, it cannot be assured that the total market value of the combined company’s common stock will remain the same after the Reverse Stock Split is effected, or that the Reverse Stock Split will not have an adverse effect on the combined company’s stock price due to the reduced number of shares outstanding after the Reverse Stock Split.

Risks Related to the Combined Company

Following completion of the Merger, the combined company will be susceptible to many of the risks described in the sections titled “Risks Related to Homology’s Business” and “Risks Related to Q32’s Business” in this proxy statement/prospectus. To the extent any of the events in the risks described in those sections occur, the potential benefits of the Merger may not be realized and the results of operations and financial condition of the combined company could be adversely affected in a material way. This could cause the market price of the combined company’s common stock to decline.

The market price of the combined company’s common stock is expected to be volatile, and the market price of the common stock may drop following the Merger.

The market price of the combined company’s common stock following the Merger could be subject to significant fluctuations. Some of the factors that may cause the market price of the combined company’s common stock to fluctuate include:

 

  •  

results of clinical trials and preclinical studies of the combined company’s product candidates, or those of the combined company’s competitors or the combined company’s existing or future collaborators;

 

  •  

failure to meet or exceed financial and development projections the combined company may provide to the public;

 

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  •  

failure to meet or exceed the financial and development projections of the investment community;

 

  •  

if the combined company does not achieve the perceived benefits of the Merger as rapidly or to the extent anticipated by financial or industry analysts;

 

  •  

announcements of significant acquisitions, strategic collaborations, joint ventures or capital commitments by the combined company or its competitors;

 

  •  

actions taken by regulatory agencies with respect to the combined company’s product candidates, clinical studies, manufacturing process or sales and marketing terms;

 

  •  

disputes or other developments relating to proprietary rights, including patents, litigation matters, and the combined company’s ability to obtain patent protection for its technologies;

 

  •  

additions or departures of key personnel;

 

  •  

significant lawsuits, including patent or stockholder litigation;

 

  •  

if securities or industry analysts do not publish research or reports about the combined company’s business, or if they issue adverse or misleading opinions regarding its business and stock;

 

  •  

changes in the market valuations of similar companies;

 

  •  

general market or macroeconomic conditions or market conditions in the pharmaceutical and biotechnology sectors;

 

  •  

sales of securities by the combined company or its securityholders in the future;

 

  •  

if the combined company fails to raise an adequate amount of capital to fund its operations or continued development of its product candidates; trading volume of the combined company’s common stock;

 

  •  

announcements by competitors of new commercial products, clinical progress or lack thereof, significant contracts, commercial relationships or capital commitments;

 

  •  

the introduction of technological innovations or new therapies that compete with the products and services of the combined company; and

 

  •  

period-to-period fluctuations in the combined company’s financial results.

Moreover, the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market fluctuations may also adversely affect the trading price of the combined company’s common stock. In addition, a recession, depression or other sustained adverse market event could materially and adversely affect the combined company’s business and the value of its common stock. In the past, following periods of volatility in the market price of a company’s securities, stockholders have often instituted class action securities litigation against such companies. Furthermore, market volatility may lead to increased shareholder activism if the combined company experiences a market valuation that activists believe is not reflective of its intrinsic value. Activist campaigns that contest or conflict with the combined company’s strategic direction or seek changes in the composition of its board of directors could have an adverse effect on its operating results, financial condition and cash flows.

The combined company may incur losses for the foreseeable future and might never achieve profitability.

The combined company may never become profitable, even if the combined company is able to complete clinical development for one or more product candidates and eventually commercialize such product candidates. The combined company will need to successfully complete significant research, development, testing and regulatory compliance activities that, together with projected general and administrative expenses, is expected to result in substantial increased operating losses for at least the next several years. Even if the combined company does achieve profitability, it may not be able to sustain or increase profitability on a quarterly or annual basis.

 

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Following the Merger, the combined company may be unable to integrate successfully the businesses of Homology and Q32 and realize the anticipated benefits of the Merger.

The Merger involves the combination of two companies that currently operate as independent companies. Following the Merger, the combined company will be required to devote significant management attention and resources to integrating its business practices and operations. The combined company may fail to realize some or all of the anticipated benefits of the Merger if the integration process takes longer than expected or is more costly than expected. Potential difficulties the combined company may encounter in the integration process include the following:

 

  •  

the inability to successfully combine the businesses of Homology and Q32 in a manner that permits the combined company to achieve the anticipated benefits from the Merger, which would result in the anticipated benefits of the Merger not being realized partly or wholly in the time frame currently anticipated or at all;

 

  •  

creation of uniform standards, controls, procedures, policies and information systems; and

 

  •  

potential unknown liabilities and unforeseen increased expenses, delays or regulatory conditions associated with the Merger.

In addition, Homology and Q32 have operated and, until the completion of the Merger, will continue to operate, independently. It is possible that the integration process also could result in the diversion of each company’s management’s attention, the disruption or interruption of, or the loss of momentum in, each company’s ongoing businesses or inconsistencies in standards, controls, procedures and policies, any of which could adversely affect the combined company’s ability to maintain its business relationships or the ability to achieve the anticipated benefits of the Merger, or could otherwise adversely affect the business and financial results of the combined company.

If the combined company fails to attract and retain management and other key personnel, it may be unable to continue to successfully develop or commercialize its product candidates or otherwise implement its business plan.

The combined company’s ability to compete in the highly competitive pharmaceuticals industry depends on its ability to attract and retain highly qualified managerial, scientific, medical, legal, sales and marketing and other personnel. The combined company will be highly dependent on its management and scientific personnel. The loss of the services of any of these individuals could impede, delay, or prevent the successful development of the combined company’s product pipeline, completion of its planned clinical trials, commercialization of its product candidates or in-licensing or acquisition of new assets and could impact negatively its ability to implement successfully its business plan. If the combined company loses the services of any of these individuals, it might not be able to find suitable replacements on a timely basis or at all, and its business could be harmed as a result. The combined company might not be able to attract or retain qualified management and other key personnel in the future due to the intense competition for qualified personnel among biotechnology, pharmaceutical and other businesses.

The combined company will need to raise additional financing in the future to fund its operations, which may not be available to it on favorable terms or at all.

The combined company will require substantial additional funds to conduct the costly and time-consuming clinical efficacy trials necessary to pursue regulatory approval of each potential product candidate. The combined company’s future capital requirements will depend upon a number of factors, including: the number and timing of future product candidates in the pipeline; progress with and results from preclinical testing and clinical trials; the ability to manufacture sufficient drug supplies to complete preclinical and clinical trials; the costs involved in preparing, filing, acquiring, prosecuting, maintaining and enforcing patent and other intellectual property claims; and the time and costs involved in obtaining regulatory approvals and favorable reimbursement or formulary

 

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acceptance. Raising additional capital may be costly or difficult to obtain and could, for example, through the sale of common stock or securities convertible or exchangeable into common stock, significantly dilute its stockholders’ ownership interests or inhibit the combined company’s ability to achieve its business objectives. If the combined company raises additional funds through public or private equity offerings, the terms of these securities may include liquidation or other preferences that adversely affect the rights of its common stockholders. In addition, any debt financing may subject the combined company to fixed payment obligations and covenants limiting or restricting its ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If the combined company raises additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, the combined company may have to relinquish certain valuable intellectual property or other rights to its product candidates, technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to it. Even if the combined company were to obtain sufficient funding, there can be no assurance that it will be available on terms acceptable to the combined company or its stockholders.

The combined company will incur additional costs and increased demands upon management as a result of complying with the laws and regulations affecting public companies.

The combined company will incur significant legal, accounting and other expenses as a public company that Q32 did not incur as a private company, including costs associated with public company reporting obligations under the Exchange Act. The combined company’s management team will consist of the executive officers of Q32 prior to the Merger, some of whom have not previously managed and operated a public company. These executive officers and other personnel will need to devote substantial time to gaining expertise related to public company reporting requirements and compliance with applicable laws and regulations to ensure that the combined company complies with all of these requirements. Any changes the combined company makes to comply with these obligations may not be sufficient to allow it to satisfy its obligations as a public company on a timely basis, or at all. These reporting requirements, rules and regulations, coupled with the increase in potential litigation exposure associated with being a public company, could also make it more difficult for the combined company to attract and retain qualified persons to serve on the board of directors or on board committees or to serve as executive officers, or to obtain certain types of insurance, including directors’ and officers’ insurance, on acceptable terms.

Upon completion of the Merger, failure by the combined company to comply with the initial listing standards of Nasdaq will prevent its stock from being listed on Nasdaq.

Upon completion of the Merger, Homology, under the new name “Q32 Bio Inc.,” will be required to meet the initial listing requirements to maintain the listing and continued trading of its shares on Nasdaq. These initial listing requirements are more difficult to achieve than the continued listing requirements. Pursuant to the Merger Agreement, Homology agreed, to the extent required by the rules and regulations of Nasdaq, to use its commercially reasonable efforts to cause the shares of Homology common stock being issued in the Merger to be approved for listing on Nasdaq at or prior to the Effective Time. Based on information currently available to Homology, Homology anticipates that its stock will be unable to meet the $4.00 (or, to the extent applicable, $3.00) minimum bid price initial listing requirement at the closing of the Merger unless it effects a reverse stock split. The board of directors of Homology intends to effect a reverse stock split of the shares of Homology common stock at a ratio of between 1:    to 1:    . In addition, often times a reverse stock split will not result in a trading price for the affected common stock that is proportional to the ratio of the split. Following the Merger, if the combined company is unable to satisfy Nasdaq listing requirements, Nasdaq may notify the combined company that its shares of common stock will not be listed on Nasdaq.

Upon a potential delisting from Nasdaq, if the common stock of the combined company is not then eligible for quotation on another market or exchange, trading of the shares could be conducted in the over-the-counter market or on an electronic bulletin board established for unlisted securities such as the Pink Sheets or the OTC Bulletin Board. In such event, it is likely that there would be significantly less liquidity in the trading of the common stock of the combined company; decreases in institutional and other investor demand for the shares,

 

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coverage by securities analysts, market making activity and information available concerning trading prices and volume; and fewer broker dealers willing to execute trades in the common stock of the combined company. Also, it may be difficult for the combined company to raise additional capital if the combined company’s common stock is not listed on a major exchange. The occurrence of any of these events could result in a further decline in the market price of the common stock of the combined company and could have a material adverse effect on the combined company.

Once the combined company is no longer an emerging growth company, a smaller reporting company or otherwise no longer qualifies for applicable exemptions, the combined company will be subject to additional laws and regulations affecting public companies that will increase the combined company’s costs and the demands on management and could harm the combined company’s operating results and cash flows.

The combined company will be subject to the reporting requirements of the Exchange Act, which requires, among other things, that the combined company file with the SEC, annual, quarterly and current reports with respect to the combined company’s business and financial condition as well as other disclosure and corporate governance requirements. However, as an emerging growth company, the combined company may take advantage of exemptions from various requirements such as an exemption from the requirement to have the combined company’s independent auditors attest to the combined company’s internal control over financial reporting under Section 404 of the Sarbanes-Oxley Act of 2002 as well as an exemption from the “say on pay” voting requirements pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010. The combined company also qualifies as a “smaller reporting company,” as such term is defined in Rule 12b-2 under the Exchange Act, which allows the combined company to take advantage of many of the same exemptions from disclosure requirements, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act and reduced disclosure obligations regarding executive compensation in this proxy statement/prospectus and in the combined company’s periodic reports and proxy statements. Once the combined company is no longer an emerging growth company or a smaller reporting company or otherwise no longer qualifies for these exemptions, the combined company will be required to comply with these additional legal and regulatory requirements applicable to public companies and will incur significant legal, accounting and other expenses to do so. If the combined company is not able to comply with the requirements in a timely manner or at all, the combined company’s financial condition or the market price of the combined company’s common stock may be harmed. For example, if the combined company or its independent auditor identifies deficiencies in the combined company’s internal control over financial reporting that are deemed to be material weaknesses, the combined company could face additional costs to remedy those deficiencies, the market price of the combined company’s stock could decline or the combined company could be subject to sanctions or investigations by the SEC or other regulatory authorities, which would require additional financial and management resources.

If the combined company fails to maintain proper and effective internal controls, its ability to produce accurate financial statements on a timely basis could be impaired.

Provided the combined company continues to be listed on Nasdaq, the combined company will be subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act and the rules and regulations of Nasdaq. The Sarbanes-Oxley Act requires, among other things, that the combined company maintain effective disclosure controls and procedures and internal control over financial reporting. The combined company must perform system and process evaluation and testing of its internal control over financial reporting to allow management to report on the effectiveness of its internal controls over financial reporting in its Annual Report on Form 10-K filing for that year, as required by Section 404 of the Sarbanes-Oxley Act. As a private company, Q32 has never been required to test its internal controls within a specified period. This will require that the combined company incur substantial professional fees and internal costs to expand its accounting and finance functions and that it expends significant management efforts. The combined company may experience difficulty in meeting these reporting requirements in a timely manner.

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internal control over financial reporting will not prevent or detect all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud will be detected.

If the combined company is not able to comply with the requirements of Section 404 of the Sarbanes-Oxley Act, or if it is unable to maintain proper and effective internal controls, the combined company may not be able to produce timely and accurate financial statements. If that were to happen, the market price of its common stock could decline and it could be subject to sanctions or investigations by Nasdaq, the SEC or other regulatory authorities.

The unaudited pro forma condensed combined financial information for Homology and Q32 included in this proxy statement/prospectus are preliminary, and the combined company’s actual financial position and operations after the Merger may differ materially from the unaudited pro forma financial information included in this proxy statement/prospectus.

The unaudited pro forma financial information for Homology and Q32 included in this proxy statement/prospectus are presented for illustrative purposes only and is not necessarily indicative of the combined company’s actual financial condition or results of operations of future periods, or the financial condition or results of operations that would have been realized had the entities been combined during the period presented. The combined company’s actual results and financial position after the Merger may differ materially and adversely from the unaudited pro forma financial information included in this proxy statement/prospectus. The exchange ratio formula reflected in this proxy statement/prospectus is preliminary. The final exchange ratio will be determined in accordance with the formula in the Merger Agreement and could differ materially from the preliminary exchange ratio used to prepare the pro forma adjustments. For more information see the section titled “Unaudited Pro Forma Condensed Combined Financial Information”.

Q32 and its independent registered public accounting firm have identified a material weakness in its internal control over financial reporting. If Q32 is unable to remediate this material weakness, or if the combined company identifies additional material weaknesses in the future or otherwise fail to maintain an effective system of internal controls, it may not be able to accurately or timely report its financial condition or results of operations, which may adversely affect its business and the market price of the combined company’s common stock.

In preparation of its consolidated financial statements to meet the requirements applicable to this Merger, Q32 and its independent registered public accounting firm identified a material weakness in its internal control over financial reporting. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.

The material weakness identified related to deficiencies in Q32 controls over complex accounting topics. Specifically, Q32’s accounting and internal control infrastructure did not allow for adequate review processes over complex accounting topics due to lack of sufficient personnel. Due to this material weakness, material errors were identified and corrected in Q32 unaudited condensed consolidated financial statements for the nine months ended September 30, 2023.

Q32 has plans to implement measures designed to improve internal controls over financial reporting to remediate the control deficiencies that led to the material weakness, including strengthening reviews by its finance team, expanding its accounting and finance team to add additional qualified accounting and finance resources, which may include augmenting its finance team with third party consultants that possess the required expertise to assist management with its review.

 

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Q32 cannot assure you that the measures it has taken to date, and actions it may take in the future, will be sufficient to remediate the control deficiencies that led to the material weakness in its internal control over financial reporting or that they will prevent or avoid potential future material weaknesses. In addition, neither its management nor an independent registered public accounting firm has performed an evaluation of its internal control over financial reporting in accordance with the provisions of the Sarbanes-Oxley Act because no such evaluation has been required. Had Q32 or its independent registered public accounting firm performed an evaluation of its internal control over financial reporting in accordance with the provisions of the Sarbanes-Oxley Act, additional material weaknesses may have been identified. If Q32 is unable to successfully remediate its existing or any future material weaknesses in its internal control over financial reporting, or identify any additional material weaknesses in the future, or otherwise fail to maintain an effective system of internal controls, the accuracy and timing of its financial reporting may be adversely affected, it may be unable to maintain compliance with securities law requirements regarding timely filing of periodic reports in addition to applicable stock exchange listing requirements, investors may lose confidence in its financial reporting, and the market price of the combined company’s common stock may decline as a result.

The combined company’s certificate of incorporation and bylaws and provisions under Delaware law could make an acquisition of the combined company more difficult and may prevent attempts by its stockholders to replace or remove its management.

If the Merger is completed, Homology’s amended and restated bylaws and Homology’s restated certificate of incorporation, as amended by the amendments thereto attached to this proxy statement/prospectus as Annex G and, assuming Proposal Nos. 2 and 3 are approved by Homology stockholders at the Homology Special Meeting, will become the combined company’s bylaws and certificate of incorporation. Provisions that will be included in the combined company’s certificate of incorporation and bylaws may discourage, delay or prevent a merger, acquisition or other change in control of the combined company that stockholders may consider favorable, including transactions in which its common stockholders might otherwise receive a premium price for their shares. These provisions could also limit the price that investors might be willing to pay in the future for shares of the combined company’s common stock, thereby depressing the market price of its common stock. In addition, because the combined company’s board of directors will be responsible for appointing the members of the combined company’s management team, these provisions may frustrate or prevent any attempts by the combined company’s stockholders to replace or remove its current management by making it more difficult for stockholders to replace members of the combined company’s board of directors. Among other things, these provisions:

 

  •  

establish a classified board of directors such that all members of the board are not elected at one time;

 

  •  

do not provide for cumulative voting in the election of directors;

 

  •  

allow the authorized number of its directors to be changed only by resolution of its board of directors;

 

  •  

provide that only the board of directors may fill vacancies on the board of directors created by the expansion of the board of directors or the resignation, death or removal of a director;

 

  •  

limit the manner in which stockholders can remove directors from the board;

 

  •  

establish advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on at stockholder meetings;

 

  •  

require that stockholder actions must be effected at a duly called stockholder meeting and prohibit actions by its stockholders by written consent;

 

  •  

limit who may call a special meeting of stockholders;

 

  •  

authorize its board of directors to issue preferred stock and to determine the terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by its board of directors; and

 

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  •  

require the approval of the holders of at least 66.67% of the votes that all its stockholders would be entitled to cast to amend or repeal certain provisions of its charter or bylaws.

Moreover, because the combined company will be incorporated in Delaware, it is governed by the provisions of Section 203 of the DGCL, which prohibits stockholders owning in excess of 15% of the outstanding combined company voting stock from merging or combining with the combined company. Although Homology and Q32 believe these provisions collectively will provide for an opportunity to receive higher bids by requiring potential acquirors to negotiate with the combined company’s board of directors, they would apply even if the offer may be considered beneficial by some stockholders. In addition, these provisions may frustrate or prevent any attempts by the combined company’s stockholders to replace or remove then current management by making it more difficult for stockholders to replace members of the board of directors, which is responsible for appointing the members of management.

The certificate of incorporation of the combined company will provide that, unless the combined company consents in writing to the selection of an alternative forum, certain designated courts will be the sole and exclusive forum for certain legal actions between the combined company and its stockholders, which could limit its stockholders’ ability to obtain a favorable judicial forum for disputes with the combined company or its directors, officers, employees or agents.

The certificate of incorporation of the combined company will provide that, unless it consents in writing to an alternative forum, the Court of Chancery of the State of Delaware is the sole and exclusive forum for state law claims for (i) any derivative action or proceeding brought on its behalf, (ii) any action asserting a claim of or based on a breach of a fiduciary duty owed by any of its current or former directors, officers, or other employees to the combined company or its stockholders, (iii) any action asserting a claim arising pursuant to any provision of the DGCL, its charter or its bylaws, or (iv) any action asserting a claim that is governed by the internal affairs doctrine, in each case subject to the Court of Chancery having personal jurisdiction over the indispensable parties named as defendants therein, which for purposes of this risk factor refers to herein as the “Delaware Forum Provision.” The Delaware Forum Provision will not apply to any causes of action arising under the Securities Act and the Exchange Act. The bylaws of the combined company will further provide that, unless it consents in writing to an alternative forum, federal district courts of the United States will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act, which for purposes of this risk factor is referred to herein as the “Federal Forum Provision.” In addition, the certificate of incorporation and bylaws of the combined company will provide that any person or entity purchasing or otherwise acquiring any interest in shares of its capital stock is deemed to have notice of and consented to the foregoing Delaware Forum Provision and Federal Forum Provision; provided, however, that stockholders cannot and will not be deemed to have waived its compliance with the U.S. federal securities laws and the rules and regulations thereunder.

The Delaware Forum Provision and the Federal Forum Provision may impose additional litigation costs on stockholders of the combined company in pursuing any such claims, particularly if the stockholders do not reside in or near the State of Delaware. Additionally, the forum selection clauses in the bylaws of the combined company may limit its stockholders’ ability to bring a claim in a judicial forum that they find favorable for disputes with the combined company or its directors, officers or employees, which may discourage such lawsuits against the combined company and its directors, officers and employees even though an action, if successful, might benefit its stockholders.

Homology and Q32 do not anticipate that the combined company will pay any cash dividends in the foreseeable future.

The current expectation is that the combined company will retain its future earnings, if any, to fund the growth of the combined company’s business as opposed to paying dividends. As a result, capital appreciation, if any, of the common stock of the combined company will be your sole source of gain, if any, for the foreseeable future.

 

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An active trading market for the combined company’s common stock may not develop and its stockholders may not be able to resell their shares of common stock for a profit, if at all.

Prior to the Merger, there had been no public market for shares of Q32 capital stock. An active trading market for the combined company’s shares of common stock may never develop or be sustained. If an active market for the combined company’s common stock does not develop or is not sustained, it may be difficult for its stockholders to sell their shares at an attractive price or at all.

Future sales of shares by existing stockholders could cause the combined company’s stock price to decline.

If existing securityholders of Homology and Q32 sell, or indicate an intention to sell, substantial amounts of the combined company’s common stock in the public market after legal restrictions on resale discussed in this proxy statement/prospectus lapse, the trading price of the common stock of the combined company could decline. Based on shares outstanding as of             ,             after giving effect to the estimated exchange ratio, which has been adjusted to reflect the proposed Reverse Stock Split, the Pre-Closing Financing and shares expected to be issued upon completion of the Merger, the combined company is expected to have outstanding a total of approximately shares of common stock immediately following the completion of the Merger. Of the              shares of common stock, approximately              shares will be available for sale in the public market beginning 180 days after the closing of the Merger as a result of the expiration of lock-up agreements between Homology and Q32 on the one hand and certain securityholders of Homology and Q32 on the other hand. All other outstanding shares of common stock, other than shares held by affiliates of the combined company and shares of Homology common stock issued in exchange for shares of Q32 common stock issued in the Pre-Closing Financing will be freely tradable, without restriction, in the public market. In addition, shares of common stock that are subject to outstanding options or warrants of Q32 will become eligible for sale in the public market to the extent permitted by the provisions of various vesting agreements and Rules 144 and 701 under the Securities Act. If these shares are sold, the trading price of the combined company’s common stock could decline.

After completion of the Merger, the combined company’s executive officers, directors and principal stockholders will have the ability to control or significantly influence all matters submitted to the combined company’s stockholders for approval.

Upon the completion of the Merger, and giving effect to the issuance of the Pre-Closing Financing, it is anticipated that the combined company’s executive officers, directors and principal stockholders will, in the aggregate, beneficially own approximately    % of the combined company’s outstanding shares of common stock, subject to certain assumptions, including, but not limited to, Homology’s net cash as of closing being equal to $60.0 million and Q32 issuing approximately $42.0 million of Q32 common stock in the Pre-Closing Financing. As a result, if these stockholders were to choose to act together, they would be able to control or significantly influence all matters submitted to the combined company’s stockholders for approval, as well as the combined company’s management and affairs. For example, these stockholders, if they choose to act together, would control or significantly influence the election of directors and approval of any merger, consolidation or sale of all or substantially all of the combined company’s assets. This concentration of voting power could delay or prevent an acquisition of the combined company on terms that other stockholders may desire.

If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about the combined company, its business or its market, its stock price and trading volume could decline.

The trading market for the combined company’s common stock will be influenced by the research and reports that equity research analysts publish about it and its business. Equity research analysts may elect to not provide research coverage of the combined company’s common stock after the completion of the Merger, and such lack of research coverage may adversely affect the market price of its common stock. In the event it does have equity research analyst coverage, the combined company will not have any control over the analysts or the content and opinions included in their reports. The price of the combined company’s common stock could decline if one or more equity research analysts downgrade its stock or issue other unfavorable commentary or

 

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research. If one or more equity research analysts ceases coverage of the combined company or fails to publish reports on it regularly, demand for its common stock could decrease, which in turn could cause its stock price or trading volume to decline.

The combined company will have broad discretion in the use of the cash and cash equivalents of the combined company and the proceeds from the Pre-Closing Financing and may invest or spend the proceeds in ways with which you do not agree and in ways that may not increase the value of your investment.

The combined company will have broad discretion over the use of the cash and cash equivalents of the combined company and the proceeds from the Pre-Closing Financing. You may not agree with the combined company’s decisions, and its use of the proceeds may not yield any return on your investment. The combined company’s failure to apply these resources effectively could compromise its ability to pursue its growth strategy and the combined company might not be able to yield a significant return, if any, on its investment of these net proceeds. You will not have the opportunity to influence its decisions on how to use the combined company’s cash resources.

Changes in tax laws or in their implementation or interpretation may adversely affect the combined company’s business and financial condition.

The rules dealing with U.S. federal, state and local income taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service and the U.S. Treasury Department. Changes to tax laws (which changes may have retroactive application) could adversely affect the combined company’s business and financial condition. In recent years, many such changes have been made and changes are likely to continue to occur in the future. The combined company cannot predict whether, when, in what form or with what effective dates, tax laws, regulations and rulings may be enacted, promulgated or decided or whether they could increase its tax liability or require changes in the manner in which it operates in order to minimize increases in its tax liability.

The combined company’s ability to use net operating loss carryforwards and other tax attributes may be limited, including as a result of the Merger.

The combined company’s ability to utilize net operating loss carryforwards, or NOLs, and other tax attributes to offset future taxable income or tax liabilities may be limited as a result of ownership changes, including, as discussed below, in connection with the Merger or other transactions. Similar rules may apply under state tax laws. If the combined company earns taxable income, such limitations could result in increased future income tax liability to the combined company, and the combined company’s future cash flows could be adversely affected.

For a more complete discussion of the risks related to the net operating loss carryforwards and certain other tax attributes of Homology and Q32, please see the discussions under “Risk Factors—Risks Related to Homology’s Business—Risks Related to Homology’s Common Stock—Homology’s ability to use net operating losses and research and development credits to offset future taxable income or income tax liabilities may be subject to certain limitations” and “Risk Factors—Risks Related to Q32’s Business—General Risk Factors—Q32’s ability to utilize its net operating loss carryforwards and certain other tax attributes may be limited,” respectively.

Unfavorable global economic conditions could adversely affect the combined company’s business, financial condition, results of operations or cash flows.

The combined company’s results of operations could be adversely affected by general conditions in the global economy and in the global financial markets. A severe or prolonged economic downturn could result in a variety of risks to the combined company’s business, including, weakened demand for the combined company’s product candidates and the combined company’s ability to raise additional capital when needed on acceptable

 

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terms, if at all. A weak or declining economy could also strain the combined company’s suppliers, possibly resulting in supply disruption. Any of the foregoing could harm the combined company’s business and the combined company cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact its business.

Risks Related to Homology’s Business

Risks Related to Homology’s Financial Position and Need for Additional Capital

Homology has incurred significant losses since inception and anticipates that it will incur continued losses for the foreseeable future. If Homology is unable to achieve and sustain profitability, the market value of its common stock will likely decline. Homology may never achieve or maintain profitability.

Homology is a clinical-stage genetic medicines company with a limited operating history. Since inception, Homology has incurred significant operating losses. Homology’s net loss for the nine months ended September 30, 2023 was $96.8 million. As of September 30, 2023, Homology had an accumulated deficit of approximately $526.0 million. On March 10, 2022, Homology closed its transaction with OXB Solutions and recorded a gain of $131.2 million on the sale of its manufacturing business which resulted in net income of $29.3 million for the nine months ended September 30, 2022 (see Note 5 to Homology’s condensed consolidated financial statements included elsewhere in this proxy statement/prospectus for additional information regarding the OXB Solutions Transaction). In addition, Homology has not commercialized any products and has never generated any revenue from product sales. Homology has historically devoted most of its financial resources to research and development, including its preclinical development activities.

In July 2023, Homology completed a review of its business and its board of directors approved a plan to explore, review and evaluate a range of potential strategic options available to Homology, including, without limitation, an acquisition, merger, reverse merger, sale of assets, strategic partnerships or other transactions. Based on the financing environment and its anticipated clinical development timeline, Homology stopped further development of its programs and reduced its workforce by 86% to significantly reduce its ongoing operating costs as Homology evaluates strategic alternatives.

Homology has incurred and expects to continue to incur costs and expenditures in connection with the process of evaluating its strategic alternatives and will continue to incur costs associated with operating as a public company. The process of continuing to evaluate strategic transactions may be costly, time-consuming and complex, and Homology may incur significant costs related to these processes, such as legal, accounting and advisory fees and expenses and other related charges. A considerable portion of these costs will be incurred regardless of whether any particular course of action is implemented or transaction is completed. Any such expenses will decrease the remaining cash available for use in Homology’s business.

Should Homology resume development of its product candidates, Homology would expect to continue to incur significant additional operating losses for the foreseeable future as it seeks to advance product candidates through preclinical and clinical development, expand its research and development activities, develop new product candidates, complete clinical trials, seek regulatory approval and, if Homology receives U.S. Food and Drug Administration, or FDA, or foreign regulatory authorities approval, commercialize its products. Furthermore, the costs of advancing product candidates into each succeeding clinical phase tend to increase substantially over time. The total costs to advance any of Homology’s product candidates to marketing approval in even a single jurisdiction would be substantial. Because of the numerous risks and uncertainties associated with genetic medicines product development, Homology is unable to accurately predict the timing or amount of increased expenses or when, or if, Homology will be able to begin generating revenue from the commercialization of products or achieve or maintain profitability. Homology’s expenses will also increase substantially if Homology:

 

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continues its current research programs and its preclinical development of product candidates from its current research programs;

 

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seeks to identify, assess, acquire and/or develop additional research programs and additional product candidates;

 

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initiates preclinical testing and clinical trials for any product candidates it identifies and develops;

 

  •  

establishes a sales, marketing and distribution infrastructure to commercialize any product candidates for which it may obtain marketing approval;

 

  •  

maintains, expands and protects its intellectual property portfolio;

 

  •  

further develops its genetic medicines platform;

 

  •  

hires additional clinical, scientific and commercial personnel;

 

  •  

adds operational, financial and management information systems and personnel, including personnel to support its product development and planned future commercialization efforts, as well as to support its operations as a public reporting company;

 

  •  

acquires or in-licenses other commercial products, product candidates and technologies;

 

  •  

makes royalty, milestone or other payments under current and any future in-license agreements; and

 

  •  

further expands its Good Manufacturing Practices, or GMP, manufacturing capacity.

Furthermore, should Homology resume development of its product candidates, its ability to successfully develop, commercialize and license its products and generate product revenue would be subject to substantial additional risks and uncertainties. Each of its programs and product candidates will require additional preclinical and clinical development, potential regulatory approval in multiple jurisdictions, securing manufacturing supply, capacity and expertise, building of a commercial organization, substantial investment and significant marketing efforts before Homology generates any revenue from product sales. These risks are further described under “—Risks Related to Discovery, Development, Clinical Testing, Manufacturing and Regulatory Approval” and “—Risks Related to Commercialization.”

As a result, Homology expects to continue to incur net losses and negative cash flows for the foreseeable future. These net losses and negative cash flows have had, and will continue to have, an adverse effect on its stockholders’ equity and working capital. The amount of Homology’s future net losses will depend, in part, on the rate of future growth of its expenses and its ability to generate revenues. If Homology is unable to develop and commercialize one or more of its product candidates either alone or with collaborators, or if revenues from any product candidate that receives marketing approval are insufficient, Homology will not achieve profitability. Even if Homology does achieve profitability, it may not be able to sustain or increase profitability. If Homology is unable to achieve and then maintain profitability, the value of its equity securities will be materially and adversely affected.

Any financial or strategic option Homology pursues may not be successful.

In July 2023, Homology’s board of directors approved a process to explore, review and evaluate a range of potential strategic options available to Homology, including, without limitation, an acquisition, merger, reverse merger, sale of assets, strategic partnerships or other transactions. The process of continuing to evaluate these strategic options has been and may continue to be costly, time-consuming and complex and Homology may incur significant costs related to this continued evaluation, such as legal, accounting and advisory fees and expenses and other related charges. There can be no assurance that the proposed Merger with Q32 will be completed, and Homology can provide no assurance that any other strategic alternative it may pursue will have a positive impact on its results of operations or financial condition.

Raising additional capital may cause dilution to Homology’s stockholders, restrict its operations or require it to relinquish rights to its technologies or product candidates.

Until such time, if ever, as Homology can generate substantial revenue, it may finance its cash needs through a combination of equity offerings, debt financings, marketing and distribution arrangements and other

 

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collaborations, strategic alliances and licensing arrangements. As of September 30, 2023, Homology does not have any committed external source of funds. In addition, Homology may seek additional capital due to favorable market conditions or strategic considerations, even if it believes that it has sufficient funds for its current or future operating plans.

To the extent that Homology raises additional capital through the sale of equity or convertible debt securities, including under its effective Registration Statement on Form S-3, the ownership interests of its stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of its common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting Homology’s ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If Homology raises additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, it may be required to relinquish valuable rights to its technologies, future revenue streams or product candidates or grant licenses on terms that may not be favorable to it. If Homology is unable to raise additional funds through equity or debt financings when needed, it may be required to delay, limit, reduce or terminate its product development or future commercialization efforts, should it resume development of its product candidates, or grant rights to develop and market product candidates that it would otherwise prefer to develop and market itself.

Homology’s decision to discontinue further program development efforts may not result in the anticipated savings for Homology and may adversely affect its business.

In connection with its decision to pursue strategic alternatives and reduce its ongoing operating expenses, in July 2023 Homology decided to stop further program developments. Based on the anticipated clinical development timeline of HMI-103 and the financing environment, Homology believes this decision to discontinue further program development efforts will significantly reduce its ongoing operating costs. Homology may not realize, in full or in part, the anticipated benefits and savings in operating expenses from this decision due to unforeseen difficulties, delays or other unexpected costs. For instance, this decision to stop further program developments may include higher than expected costs associated with winding down Homology’s clinical programs. Moreover, if Homology is unable to realize the expected cost savings, its financial condition could be adversely affected, and it may be more difficult to complete the proposed Merger with Q32 or any other potential strategic transaction.

Homology will require additional capital to fund its operations, and if Homology fails to obtain necessary financing, it may not be able to continue its operations for more than twelve months after the date the unaudited consolidated financial statements included elsewhere in this proxy statement/prospectus have been issued.

Homology will require additional capital, which it may raise through equity offerings, debt financings, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements or other sources to enable it to complete the development and potential commercialization of its product candidates and any future product candidates should it resume such activities. In addition, Homology may not be able to enter into any collaborations that will generate significant cash. Adequate additional financing may not be available to Homology on acceptable terms, or at all. Homology’s failure to raise capital as and when needed would have a negative effect on its financial condition and its ability to pursue its business strategy. In addition, attempting to secure additional financing may divert the time and attention of Homology’s management from day-to-day activities.

Based upon its current projections, Homology believes that its existing cash, cash equivalents, and short-term investments will enable it to continue to fund its operations for at least one year from the date its unaudited consolidated financial statements for the period ended September 30, 2023 included elsewhere in this proxy statement/prospectus were issued. However, due to considerations of certain qualitative factors, including the

 

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discontinuation of all clinical trials and research activities, as well as Homology’s significant reduction in force of all but a few custodial employees, Homology’s management has concluded that there is substantial doubt regarding Homology’s ability to continue as a going concern for more than twelve months after the date the unaudited condensed consolidated financial statements included elsewhere in this proxy statement/prospectus have been issued. Beyond that, Homology will need to raise additional capital in order to fund operating expenses and capital expenditure requirements. This estimate is based on assumptions that may prove to be wrong, and Homology could use its available capital resources sooner than it currently expects. In addition, its resource requirements could materially change depending on the outcome of its ongoing strategic alternative review process. As a result, Homology is unable to estimate the exact amount of its working capital requirements. Changing circumstances could cause Homology to consume capital significantly faster than it currently anticipates, and it may need to spend more than currently expected because of circumstances beyond its control. Should Homology resume development of its product candidates, its future funding requirements, both near and long-term, would depend on many factors, including, but not limited to:

 

  •  

the initiation, progress, timing, costs and results of Homology’s planned clinical trials for its product candidates;

 

  •  

the outcome, timing and cost of meeting regulatory requirements established by the FDA and other comparable foreign regulatory authorities;

 

  •  

the cost of filing, prosecuting, defending and enforcing Homology’s patent claims and other intellectual property rights;

 

  •  

the cost of defending potential intellectual property disputes, including patent infringement actions brought by third parties against Homology or its product candidates;

 

  •  

the effect of competing technological and market developments;

 

  •  

the cost and timing of completion of commercial-scale manufacturing activities;

 

  •  

the costs of operating as a public company;

 

  •  

the extent to which Homology in-licenses or acquires other products and technologies;

 

  •  

the cost of establishing sales, marketing and distribution capabilities for Homology’s product candidates in regions where it chooses to commercialize its products; and

 

  •  

the initiation, progress, timing and results of Homology’s commercialization of its product candidates, if approved for commercial sale.

Homology maintains the majority of its cash and cash equivalents in accounts with major U.S. and multi-national financial institutions, and Homology’s deposits at these institutions exceed insured limits. Market conditions can impact the viability of these institutions. In the event of failure of any of the financial institutions where Homology maintains its cash and cash equivalents, there can be no assurance that Homology would be able to access uninsured funds in a timely manner or at all. Any inability to access or delay in accessing these funds could adversely affect its business and financial position.

Homology cannot be certain that additional funding will be available on acceptable terms, or at all. For example, the trading prices for Homology’s and other biopharmaceutical companies’ stock have been highly volatile as a result of macroeconomic conditions, developments in the industry and COVID-19. As a result, Homology may face difficulties raising capital through sales of its common stock and any such sales may be on unfavorable terms. If Homology is unable to raise additional capital in sufficient amounts or on terms acceptable to it, it may have to significantly delay, scale back or discontinue the development or commercialization of or product candidates or potentially discontinue operations.

 

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Homology has a limited operating history and no history of commercializing genetic medicine products, which may make it difficult to evaluate the prospects for its future viability.

Homology was established and began operations in 2015. Homology’s operations to date have been limited to financing and staffing its company, developing its technology and identifying and developing its product candidates. Homology has not yet demonstrated an ability to successfully complete any clinical trials, including large-scale, pivotal clinical trials, obtain marketing approval, manufacture a commercial scale product, or arrange for a third party to do so on its behalf, or conduct sales and marketing activities necessary for successful product commercialization. Typically, it takes about six to ten years to develop a new drug from the time it enters Phase 1 clinical trials to when it is approved for treating patients, but in many cases, it may take longer. Consequently, should Homology resume development of its product candidates, predictions about its future success or viability may not be as accurate as they could be if it had a longer operating history or a history of successfully developing and commercializing genetic medicine products.

In addition, as a business with a limited operating history, Homology may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors. Homology will eventually need to transition from a company with a research focus to a company capable of supporting commercial activities. Homology may not be successful in such a transition.

Homology expects its financial condition and operating results may fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many of which are beyond its control. Accordingly, you should not rely upon the results of any particular quarterly or annual period as indications of future operating performance.

Should Homology resume development of its product candidates, Homology would be heavily dependent on the success of its product candidates, and if none of its candidates receives regulatory approval or is not successfully commercialized, its business may be harmed.

Homology has historically invested a significant portion of its efforts and financial resources in the development of its product candidates. Homology’s future success and ability to generate product revenue is substantially dependent on its ability to successfully develop, obtain regulatory approval for and successfully commercialize its product candidates. Homology currently has no products that are approved for commercial sale and may never be able to develop marketable products, and it has stopped development activities. Should Homology resume development of its product candidates, Homology expects that a substantial portion of its efforts and expenditures over the next few years would be devoted to development of these candidates, which would require additional clinical development, management of clinical and manufacturing activities, regulatory approval in multiple jurisdictions, securing manufacturing supply, building of a commercial organization, substantial investment and significant marketing efforts before Homology can generate any revenues from any commercial sales. Accordingly, Homology’s business has historically depended heavily on the successful development, regulatory approval and commercialization of its product candidates, which may never occur. Therefore, Homology cannot be certain that any of its product candidates would be successful in future clinical trials, receive regulatory approval or be successfully commercialized even if Homology receives regulatory approval.

Even if Homology receives approval to market any product candidate from the FDA or other regulatory authorities, Homology cannot be certain that its product candidates will be successfully commercialized, widely accepted in the marketplace or more effective than other commercially available alternatives. Additionally, the research, testing, manufacturing, labeling, approval, sale, marketing and distribution of genetic medicine products are and will remain subject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries that each have differing regulations. Homology is not permitted to market any product candidate in the United States until it receives approval of a Biologics License Application, or BLA from the FDA, or in any foreign countries until it receives the requisite approval from such countries.

 

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Homology has not submitted a BLA to the FDA or comparable applications to other regulatory authorities and does not expect to be in a position to do so for the foreseeable future.

If any of Homology’s product candidates shows unexpected adverse events or a lack of efficacy in the indications it intends to treat, or if it experiences other regulatory or developmental issues, its development plans and business could be significantly harmed. Further, competitors may be developing products with similar technology and may experience problems with their products that could identify problems that would potentially harm Homology’s business.

Homology may not be successful in its efforts to identify additional product candidates.

Historically, part of Homology’s strategy has involved, and to the extent such activities are resumed in the future may involve, identifying novel product candidates. The process by which Homology identifies product candidates may fail to yield product candidates for clinical development for a number of reasons, including those discussed in these risk factors and also:

 

  •  

Homology may not be able to assemble sufficient resources to acquire or discover additional product candidates;

 

  •  

competitors may develop alternatives that render Homology’s potential product candidates obsolete or less attractive;

 

  •  

potential product candidates Homology develops may nevertheless be covered by third parties’ patents or other exclusive rights;

 

  •  

potential product candidates may, on further study, be shown to have harmful side effects, toxicities or other characteristics that indicate that they are unlikely to be products that will receive marketing approval and achieve market acceptance;

 

  •  

potential product candidates may not be effective in treating their targeted diseases;

 

  •  

the market for a potential product candidate may change so that the continued development of that product candidate is no longer reasonable;

 

  •  

a potential product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all; or

 

  •  

the regulatory pathway for a potential product candidate may be complex and difficult to navigate successfully or economically.

In addition, should Homology resume development of its product candidates, Homology may choose to focus its efforts and resources on a potential product candidate that ultimately proves to be unsuccessful. As a result, Homology may fail to capitalize on viable commercial products or profitable market opportunities, be required to forego or delay pursuit of opportunities with other product candidates or other diseases that may later prove to have greater commercial potential, or relinquish valuable rights to such product candidates through collaboration, licensing or other royalty arrangements in cases in which it would have been advantageous for Homology to retain sole development and commercialization rights. If Homology is unable to identify additional suitable product candidates for clinical development, this would adversely impact its business strategy and its financial position and share price and could potentially cause it to cease operations.

Homology may be required to make significant payments in connection with its license agreement with the City of Hope.

Under its license agreement with the City of Hope, Homology is subject to significant obligations, including payment obligations upon achievement of specified milestones and royalties on product sales, as well as other material obligations, including potential payments if Homology were to sublicense the COH technology to

 

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additional strategic collaborators. If these payments become due, Homology may not have sufficient funds available to meet its obligations or it may have to direct funds from other development efforts, and as a result, its development efforts may be materially harmed.

Risks Related to Discovery, Development, Clinical Testing, Manufacturing and Regulatory Approval

Should Homology resume development its of product candidates, Homology intends to identify and develop product candidates based on its novel genetic medicines platform, which makes it difficult to predict the time and cost of product candidate development. No products that utilize gene editing technology have been approved in the United States, and there have only been a limited number of human clinical trials involving a gene editing product candidate. Moreover, none of those trials has involved Homology’s nuclease-free gene editing technology, prior to its initiated Phase 1 pheEDIT clinical trial. In addition, there have been a limited number of gene therapy products approved in the United States or in Europe and none of these products have utilized Homology’s AAVHSC platform.

Homology has historically concentrated its research and development efforts on its genetic medicines platform, which uses both nuclease-free gene editing and gene therapy technologies. Homology’s future success depends on the successful development of this novel therapeutic approach. To date, no product that utilizes gene editing has been approved in the United States. There have been a limited number of clinical trials of gene editing technologies, however no product candidates have been approved, and, prior to Homology’s initiated Phase 1 pheEDIT clinical trial, none of these clinical trials involved product candidates that utilize Homology’s novel gene correction editing technology. Moreover, there have been a limited number of gene therapy products approved in the United States or in Europe and none of these products have utilized Homology’s AAVHSC platform. In addition, because its programs, prior to Homology’s pausing of further product development, were all in the research, preclinical or early-clinical stage, Homology has not been able to fully assess safety in humans, and there may be long-term effects from treatment with any of its future product candidates that it cannot predict at this time. Any gene correction editing product candidates Homology may develop will act at the level of DNA, and, because animal DNA differs from human DNA, it will be difficult for Homology to test its future product candidates in animal models for either safety or efficacy. Also, animal models may not exist for some of the diseases Homology expects to pursue, should Homology resume development of its product candidates. Homology’s genetic medicines platform is based on a family of 15 proprietary AAVHSCs which Homology can deploy through a nuclease-free gene editing modality, gene therapy, or GTx-mAb, which is designed to produce antibodies throughout the body. All applications rely on the unique ability of Homology’s AAVHSCs to efficiently target multiple tissues in the body. The mechanism of action by which these vectors target particular tissues is still not completely understood. Therefore, it is difficult for Homology to determine that its vectors will be able to properly integrate corrective DNA in or deliver gene transfer constructs to enough tissue cells to reach therapeutic levels. Should Homology resume development its of product candidates, Homology cannot be certain that its AAVHSCs will be able to meet safety and efficacy levels needed to be therapeutic in humans or that they will not cause significant adverse events or toxicities. Furthermore, studies conducted by a third party in non-human primates, or NHPs, suggest that intravenous delivery of certain AAV vectors at very high doses may result in severe toxicity of the dorsal root ganglion, or DRG. To date, Homology has not observed the severe DRG toxicities described in these publications after intravenous administration in NHPs with its naturally occurring AAVHSC vectors, and Homology has not seen these toxicities in its product candidates. However, Homology cannot be certain that it will be able to avoid triggering toxicities in any future preclinical or clinical studies it may conduct with its product candidates. Any such results could impact Homology’s ability to develop a product candidate. As a result of these factors, it is more difficult for Homology to predict the time and cost of product candidate development, and Homology cannot predict whether the application of its genetic medicines platform, or any similar or competitive gene therapy or gene editing platforms, will result in the identification, development, and regulatory approval of any medicines, or that other genetic medicine technologies will not be considered better or more attractive for the development of medicines. There can be no assurance that any development problems Homology experiences in the future related to its genetic medicines platform or any of its research programs will not cause significant delays or unanticipated

 

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costs, or that such development problems can be solved. Homology may also experience delays in developing a sustainable, reproducible, and scalable manufacturing process or transferring that process to commercial partners. Any of these factors may prevent Homology from completing its preclinical studies or any clinical trials that Homology may initiate, should Homology resume development of its product candidates, or commercializing any product candidates Homology may develop on a timely or profitable basis, if at all.

Because gene therapy and gene editing are novel and the regulatory landscape that governs any product candidates Homology may develop is uncertain and continues to change, Homology cannot predict the time and cost of obtaining regulatory approval, if it receives it at all, for any product candidates it may develop to the extent it resumes such activities.

Regulatory requirements governing products created with genome editing technology or involving gene therapy treatment have changed frequently and will likely continue to change in the future. Approvals by one regulatory authority may not be indicative of what any other regulatory authority may require for approval, and there is substantial, and sometimes uncoordinated, overlap in those responsible for regulation of gene therapy products, cell therapy products and other products created with genome editing technology. For example, the FDA maintains the Office of Therapeutic Products within its Center for Biologics Evaluation and Research, or CBER, with responsibility for the review of gene therapy and related products, and the Cellular, Tissue and Gene Therapies Advisory Committee to advise CBER on its review. Should Homology resume development of its product candidates, these and other regulatory review agencies, committees and advisory groups and any requirements and guidelines they promulgate may lengthen the regulatory review process, require Homology to perform additional preclinical studies or clinical trials, increase its development costs, lead to changes in regulatory positions and interpretations, delay or prevent approval and commercialization of these treatment candidates or lead to significant post-approval limitations or restrictions.

Additionally, under NIH Guidelines supervision of human gene transfer trials includes evaluation and assessment by an institutional biosafety committee, or IBC, a local institutional committee that reviews and oversees research utilizing recombinant or synthetic nucleic acid molecules at that institution. The IBC assesses the safety of the research and identifies any potential risk to public health or the environment, and such review may result in some delay before initiation of a clinical trial. While the NIH Guidelines are not mandatory unless the research in question is being conducted at or sponsored by institutions receiving NIH funding of recombinant or synthetic nucleic acid molecule research, many companies and other institutions not otherwise subject to the NIH Guidelines voluntarily follow them.

In the European Union, or EU, the European Medicines Agency, or EMA, has a Committee for Advanced Therapies, or CAT, that, in conjunction with the Committee for Medicinal Products for Human Use, or CHMP, is responsible for assessing the quality, safety and efficacy of advanced therapy medicinal products, or ATMPs. ATMPs include gene therapy medicines, somatic-cell therapy medicines and tissue-engineered medicines. The role of the CAT is to prepare a draft opinion on an application for marketing authorization for a gene therapy medicinal candidate that is submitted to the EMA. The CAT’s opinion is considered by the CHMP when giving its final recommendation regarding the authorization of a product in view of the balance of benefits and risks identified. Although the CAT’s draft opinion is submitted to the CHMP for final approval, the CHMP may depart from the draft opinion, if it provides detailed scientific justification. In the EU, the development and evaluation of a gene therapy medicinal product must be considered in the context of the relevant EU guidelines. The CHMP and CAT are also responsible for providing guidelines on ATMPs and have published numerous guidelines, including specific guidelines on gene therapies and cell therapies. These guidelines provide additional guidance on the factors that the EMA will consider in relation to the development and evaluation of ATMPs and include, among other things, the preclinical studies required to characterize ATMPs; the manufacturing and control information that should be submitted in a marketing authorization application; and post-approval measures required to monitor patients and evaluate the long-term efficacy and potential adverse reactions of ATMPs. Although these guidelines are not legally binding, Homology believes that its compliance with them is likely necessary to gain and maintain approval for any of its product candidates. In addition, the EMA may issue new

 

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guidelines concerning the development and marketing authorization for gene therapy medicinal products and require that Homology complies with these new guidelines. Similarly complex regulatory environments exist in other jurisdictions in which Homology might consider seeking regulatory approvals for its product candidates, further complicating the regulatory landscape. As a result, the procedures and standards applied to gene therapy products and cell therapy products may be applied to any of Homology’s gene therapy or genome editing product candidates, but that remains uncertain at this point.

The clinical trial requirements of the FDA, the EMA and other regulatory authorities and the criteria these regulators use to evaluate the safety and efficacy of a product candidate vary substantially according to the type, complexity, novelty and intended use and market of the potential products. The regulatory approval process for product candidates created with novel genome editing technology such as Homology’s can be more lengthy, rigorous and expensive than the process for other better known or more extensively studied product candidates and technologies. To the extent Homology resumes its activities developing novel treatments for diseases in which there is little clinical experience with new endpoints and methodologies, there is heightened risk that the FDA, the EMA or comparable regulatory authorities may not consider the clinical trial endpoints to provide clinically meaningful results, and the resulting clinical data and results may be more difficult to analyze. This may be a particularly significant risk for many of the genetically defined diseases for which Homology may develop product candidates alone or with collaborators due to small patient populations for those diseases, and designing and executing a rigorous clinical trial with appropriate statistical power is more difficult than with diseases that have larger patient populations. Regulatory authorities administering existing or future regulations or legislation may not allow production and marketing of products utilizing genome editing technology in a timely manner or under technically or commercially feasible conditions. Even if Homology’s product candidates obtain required regulatory approvals, such approvals may later be withdrawn as a result of changes in statute or regulations or the interpretation of new available data by applicable regulatory agencies.

Changes in applicable regulatory guidelines may lengthen the regulatory review process for Homology’s product candidates, require additional studies or trials, increase development costs, lead to changes in regulatory positions and interpretations, delay or prevent approval and commercialization of such product candidates, or lead to significant post-approval limitations or restrictions. Additionally, adverse developments in clinical trials conducted by others of gene therapy products or products created using genome editing technology, or adverse public perception of the field of genome editing, may cause the FDA and other regulatory authorities to revise the requirements for approval of any product candidates Homology may develop or limit the use of products utilizing genome editing technologies, either of which could materially harm its business. Furthermore, regulatory action or private litigation could result in expenses, delays or other impediments to Homology’s research programs or the development or commercialization of current or future product candidates.

Should Homology resume development of its product candidates, Homology would be required to consult with these regulatory and advisory groups and comply with all applicable guidelines, rules and regulations. If Homology fails to do so, it may be required to delay or terminate development of such product candidates. Delay or failure to obtain, or unexpected costs in obtaining, the regulatory approval necessary to bring a product candidate to market could decrease Homology’s ability to generate sufficient product revenue to maintain its business.

Clinical trials are expensive, time-consuming, difficult to design and implement, and involve an uncertain outcome.

Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. Should Homology resume development of its product candidates, the results of preclinical studies and early clinical trials of its product candidates may not be predictive of the results of later-stage clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials. A number of companies in the biotechnology and genetic medicines industries have suffered

 

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significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials. Even if its current and future clinical trials are completed as planned, Homology cannot be certain that their results will establish the safety, purity, potency and/or effectiveness of any of its product candidates to the satisfaction of the FDA or other regulatory authorities, even if Homology believes that such trials were successful.

To date, Homology has not completed any clinical trials for its product candidates. Should Homology resume development of its product candidates, Homology may experience delays in conducting any clinical trials and Homology does not know whether planned clinical trials will begin on time, need to be redesigned, recruit and enroll patients on time or be completed on schedule, or at all. Clinical trials can be delayed or terminated for a variety of reasons, including delays or failures related to:

 

  •  

the FDA or comparable foreign regulatory authorities disagreeing as to the design or implementation of Homology’s clinical studies;

 

  •  

obtaining regulatory approval to commence a trial;

 

  •  

reaching an agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

 

  •  

obtaining institutional review board, or IRB, and ethics committee approval or positive opinion at each site;

 

  •  

recruiting suitable patients to participate in a trial;

 

  •  

developing and validating the companion diagnostic to be used in a clinical trial, if applicable;

 

  •  

having patients complete a trial or return for post-treatment follow-up;

 

  •  

clinical sites deviating from trial protocol or dropping out of a trial;

 

  •  

addressing patient safety concerns that arise during the course of a trial;

 

  •  

adding a sufficient number of clinical trial sites; or

 

  •  

manufacturing sufficient quantities of product candidate for use in clinical trials.

Should Homology resume development of its product candidates, it may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent its ability to receive marketing approval or commercialize its product candidates or significantly increase the cost of such trials, including:

 

  •  

Homology may receive feedback from regulatory authorities that requires it to modify the design of its clinical trials;

 

  •  

clinical trials of Homology’s product candidates may produce negative safety and/or efficacy data or inconclusive results, and it may decide, or regulators may require it, to conduct additional clinical trials or abandon development programs;

 

  •  

the number of patients required for clinical trials of Homology’s product candidates may be larger than Homology anticipates, enrollment in these clinical trials may be slower than it anticipates or participants may drop out of these clinical trials at a higher rate than it anticipates;

 

  •  

Homology’s third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to Homology in a timely manner, or at all;

 

  •  

Homology or its investigators might have to suspend or terminate clinical trials of Homology’s product candidates for various reasons, including non-compliance with regulatory requirements, a finding that Homology’s product candidates have undesirable side effects or other unexpected characteristics, or a finding that the participants are being exposed to unacceptable health risks;

 

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  •  

the cost of clinical trials of Homology’s product candidates may be greater than Homology anticipates and it may not have funds to cover the costs;

 

  •  

the supply or quality of Homology’s product candidates or other materials necessary to conduct clinical trials of its product candidates may be insufficient or inadequate;

 

  •  

regulators may revise the requirements for approving Homology’s product candidates, or such requirements may not be as Homology anticipates; and

 

  •  

any future collaborators that conduct clinical trials may face any of the above issues, and may conduct clinical trials in ways they view as advantageous to them but that are suboptimal for Homology.

If Homology is required to conduct additional clinical trials or other testing of its product candidates beyond those that it contemplates, if it is unable to successfully complete clinical trials of its product candidates or other testing, if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns, Homology may:

 

  •  

incur unplanned costs;

 

  •  

be delayed in obtaining marketing approval for Homology’s product candidates or not obtain marketing approval at all;

 

  •  

obtain marketing approval in some countries and not in others;

 

  •  

obtain marketing approval for indications or patient populations that are not as broad as intended or desired;

 

  •  

obtain marketing approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings;

 

  •  

be subject to additional post-marketing testing requirements; or

 

  •  

have the product removed from the market after obtaining marketing approval.

Homology could encounter further delays if a clinical trial is suspended or terminated by it, by the IRBs of the institutions in which such trials are being conducted, by the Data Monitoring Committee, or DMC, for such trial or by the FDA or other regulatory authorities. Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or Homology’s clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. Furthermore, Homology may rely on CROs and clinical trial sites to ensure the proper and timely conduct of clinical trials and while Homology would have agreements governing their committed activities, Homology would have limited influence over their actual performance, as described in “—Risks Related to Homology’s Dependence on Third Parties.”

To the extent Homology were to resume such activities, all of its product candidates would require extensive clinical testing before it is prepared to submit a BLA or similar applications seeking regulatory approval. Homology cannot predict with any certainty if or when it might complete the development of any of its product candidate and submit a BLA or similar applications or whether any such BLA or similar applications will be approved by the FDA or comparable foreign authorities. Homology may seek feedback from the FDA or other regulatory authorities on its clinical development program, and the FDA or such regulatory authorities may not provide such feedback on a timely basis, or such feedback may not be favorable, which could further delay its development programs.

If Homology experiences delays in the commencement or completion of its clinical trials, or if Homology terminates a clinical trial prior to completion, the commercial prospects of its product candidates could be

 

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harmed, and its ability to generate revenues from its product candidates may be delayed. In addition, any delays in Homology’s clinical trials could increase its costs, slow down the development and approval process and jeopardize its ability to commence product sales and generate revenues. Any of these occurrences may harm Homology’s business, financial condition and results of operations. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of its product candidates.

In addition, the FDA’s and other regulatory authorities’ policies with respect to clinical trials may change and additional government regulations may be enacted. For instance, the regulatory landscape related to clinical trials in the EU recently evolved. The EU Clinical Trials Regulation, or CTR, which was adopted in April 2014 and repeals the EU Clinical Trials Directive, became applicable on January 31, 2022. While the Clinical Trials Directive required a separate clinical trial application, or CTA, to be submitted in each member state in which the clinical trial takes place, to both the competent national health authority and an independent ethics committee, the CTR introduces a centralized process and only requires the submission of a single application for multi-center trials. The CTR allows sponsors to make a single submission to both the competent authority and an ethics committee in each member state, leading to a single decision per member state. The assessment procedure of the CTA has been harmonized as well, including a joint assessment by all member states concerned, and a separate assessment by each member state with respect to specific requirements related to its own territory, including ethics rules. Each member state’s decision is communicated to the sponsor via the centralized EU portal. Once the CTA is approved, clinical study development may proceed. The CTR provides for a three-year transition period. Clinical trials for which an application was submitted (i) prior to January 31, 2022 under the Clinical Trials Directive, or (ii) between January 31, 2022 and January 31, 2023 and for which the sponsor has opted for the application of the EU Clinical Trials Directive remain governed by said Clinical Trial Directive until January 31, 2025. After this date, all clinical trials (including those which are ongoing) will become subject to the provisions of the CTR. Compliance with the CTR requirements by Homology and its third-party service providers, such as clinical research organizations, or CROs, may impact its developments plans.

It is currently unclear to what extent the United Kingdom, or UK, will seek to align its regulations with the EU. The UK regulatory framework in relation to clinical trials is derived from existing EU legislation (as implemented into UK law, through secondary legislation). On January 17, 2022, the UK Medicines and Healthcare Regulatory Agency, or MHRA, launched an eight-week consultation on reframing the UK legislation for clinical trials, with the aim to streamline clinical trials approvals, enable innovation, enhance clinical trials transparency, enable greater risk proportionality, and promote patient and public involvement in clinical trials. The UK Government published its response to the consultation on March 21, 2023 confirming that it would bring forward changes to the legislation. These resulting legislative amendments will be closely watched and will determine how closely the UK regulations are aligned with the CTR. Under the terms of the Protocol on Ireland/Northern Ireland, provisions of the CTR which relate to the manufacture and import of investigational medicinal products and auxiliary medicinal products apply in Northern Ireland. On February 27, 2023, the UK Government and the European Commission reached a political agreement on the “Windsor Framework” which will revise the Protocol on Ireland/Northern Ireland in order to address some of the perceived shortcomings in its operation. Once implemented, this may have further impact on the application of the CTR in Northern Ireland. A decision by the UK Government not to closely align any new legislation with the new approach adopted in the EU may have an effect on the cost of conducting clinical trials in the UK as opposed to other countries.

If Homology is slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies governing clinical trials, its development plans may also be adversely impacted.

Adverse public perception of genetic medicine, and gene editing in particular, may negatively impact the length of time required to advance Homology’s product candidates through clinical trials should Homology resume development of its product candidates, including the pace at which Homology advances patient enrollment, and potential regulatory approval of, or demand for, its potential products.

Some of Homology’s therapeutic candidates involved editing the human genome. If Homology resumes the development of its product candidates in the future, the clinical and commercial success of Homology’s potential

 

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products, should Homology resume development of such potential products, will depend in part on public acceptance of the use of gene editing and gene therapy for the prevention or treatment of human diseases. Public attitudes may be influenced by claims that gene therapy and gene editing are unsafe, unethical, or immoral, and, consequently, Homology’s products may not gain the acceptance of the public or the medical community. Adverse public attitudes may adversely impact Homology’s ability to enroll clinical trials. Moreover, Homology’s success will depend upon physicians prescribing, and their patients being willing to receive, treatments that involve the use of product candidates Homology may develop in lieu of, or in addition to, existing treatments with which they are already familiar and for which greater clinical data may be available.

In addition, gene editing technology is subject to public debate and heightened regulatory scrutiny due to ethical concerns relating to the application of gene editing technology to human embryos or the human germline. For example, in April 2015, Chinese scientists reported on their attempts to edit the genome of human embryos to modify the gene for hemoglobin beta. This is the gene in which a mutation occurs in patients with the inherited blood disorder beta thalassemia. Although this research was purposefully conducted in embryos that were not viable, the work prompted calls for a moratorium or other types of restrictions on gene editing of human eggs, sperm, and embryos. The Alliance for Regenerative Medicine in Washington, D.C. has called for a voluntary moratorium on the use of gene editing technologies in research that involved altering human embryos or human germline cells. Similarly, the NIH has announced that it would not fund any use of gene editing technologies in human embryos, noting that there are multiple existing legislative and regulatory prohibitions against such work, including the Dickey-Wicker Amendment, which prohibits the use of appropriated funds for the creation of human embryos for research purposes or for research in which human embryos are destroyed. Laws in the UK prohibit genetically modified embryos from being implanted into women, but embryos can be altered in research labs under license from the Human Fertilisation and Embryology Authority. Research on embryos is more tightly controlled in many other European countries.

Although Homology does not use its technologies to edit human embryos or the human germline, should it resume development of its product candidates, such public debate about the use of gene editing technologies in human embryos and heightened regulatory scrutiny could prevent or delay its development of product candidates. More restrictive government regulations or negative public opinion would have a negative effect on Homology’s business or financial condition and may delay or impair its development and commercialization of product candidates or demand for any products Homology may develop. Adverse events in Homology’s preclinical studies or clinical trials or those of its competitors or of academic researchers utilizing gene therapy or gene editing technologies, even if not ultimately attributable to product candidates Homology may discover and develop, and the resulting publicity could result in increased governmental regulation, unfavorable public perception, potential regulatory delays in the testing or approval of potential product candidates Homology may identify and develop, stricter labeling requirements for those product candidates that are approved, a decrease in demand for any such product candidates and a suspension or withdrawal of approval by regulatory authorities of Homology’s product candidates.

A Breakthrough Therapy Designation from the FDA, even if granted for any of Homology’s product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that Homology’s product candidates will receive marketing approval.

Should Homology resume development of its product candidates, Homology may seek a Breakthrough Therapy Designation for its product candidates if the clinical data support such a designation for one or more product candidates to the extent it resumes development of its product candidates. A breakthrough therapy is defined as a drug or biologic that is intended, alone or in combination with one or more other drugs or biologics, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug, or biologic in Homology’s case, may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For product candidates that have been designated as breakthrough therapies, interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for

 

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clinical development while minimizing the number of patients placed in ineffective control regimens. Biologics designated as breakthrough therapies by the FDA may also be eligible for priority review and rolling review of a BLA, if the relevant criteria are met.

Designation as a breakthrough therapy is within the discretion of the FDA. Accordingly, even if Homology believes one of its product candidates meets the criteria for designation as a breakthrough therapy, the FDA may disagree and instead determine not to make such designation. In any event, the receipt of a Breakthrough Therapy Designation for a product candidate may not result in a faster development process, review or approval compared to drugs considered for approval under non-expedited FDA review procedures and does not assure ultimate approval by the FDA. In addition, even if one or more of Homology’s product candidates qualify as breakthrough therapies, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.

A Fast Track Designation from the FDA, even if granted for any of Homology’s product candidates, may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that Homology’s product candidates will receive marketing approval.

On May 1, 2019, Homology received Fast Track Designation for HMI-102 for the prevention or treatment of neurocognitive defects due to phenylalanine hydroxylase deficiency through normalization of circulating phenylalanine levels, and on October 25, 2021, Homology received Fast Track Designation for HMI-103 for the treatment of neurocognitive and neuropsychiatric manifestations of PKU secondary to phenylalanine hydroxylase deficiency. Should Homology resume development of its product candidates, Homology may seek such designation for some or all of its other product candidates. If a drug or biologic, in Homology’s case, is intended for the treatment of a serious or life-threatening condition and the biologic demonstrates the potential to address unmet medical needs for this condition, the biologic sponsor may also apply for FDA Fast Track Designation. The sponsor of a Fast Track product candidate has opportunities for more frequent interactions with the applicable FDA review team during product development and, once a BLA is submitted, the product candidate may be eligible for priority review. A Fast Track product candidate may also be eligible for rolling review, where the FDA may consider for review sections of the BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the BLA, the FDA agrees to accept sections of the BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the BLA. The FDA has broad discretion whether or not to grant this designation. Even if Homology believes a particular product candidate is eligible for this designation, it cannot assure you that the FDA would decide to grant it. Even if Homology does receive Fast Track Designation, it may not experience a faster development process, review or approval compared to conventional FDA procedures. The FDA may withdraw Fast Track Designation if it believes that the designation is no longer supported by data from Homology’s clinical development program. Many biologics that have received Fast Track Designation have failed to obtain approval.

In the future Homology may seek EMA PRIME designation or apply for other expedited regulatory pathways, designations, schemes or tools in the EU or UK for one or more of its product candidates, which Homology may not receive. Such designations may not lead to a faster development or regulatory review or approval process and do not increase the likelihood that its product candidates will receive marketing authorization.

In the future Homology may seek EMA PRIME (Priority Medicines) designation or other designations, schemes or tools for one or more of its product candidates. In the EU, innovative products that target an unmet medical need and are expected to be of major public health interest may be eligible for a number of expedited development and review programs, such as the PRIME scheme, which provides incentives similar to the Breakthrough Therapy and Fast-Track designation in the United States. PRIME is a voluntary scheme aimed at enhancing the EMA’s support for the development of medicines that target unmet medical needs. It is based on increased interaction and early dialogue with companies developing promising medicines, to optimize their product development plans and speed up their evaluation to help them reach patients earlier. The benefits of a

 

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PRIME designation include the appointment of a rapporteur before submission of a marketing authorization application, early dialogue and scientific advice at key development milestones, and the potential to qualify products for accelerated review earlier in the application process.

Even if Homology believes one of its product candidates is eligible for PRIME, the EMA may disagree and instead determine not to make such designation. The EMA PRIME scheme or other schemes, designations, or tools, even if obtained or used for any of Homology’s product candidates may not lead to a faster development, regulatory review or approval process compared to therapies considered for approval under conventional procedures and do not assure ultimate approval. In addition, even if one or more of Homology’s product candidates is eligible to the PRIME scheme, the EMA may later decide that such product candidates no longer meet the conditions for qualification or decide that the time period for review or approval will not be shortened. Product developers that benefit from PRIME designation may be eligible for accelerated assessment (in 150 days instead of 210 days), which may be granted for medicinal products of major interest from a public health perspective or that target an unmet medical need, but this is not guaranteed.

Homology may equally pursue some of the post-Brexit MHRA procedures to prioritize access to new medicines that will benefit patients, such as a 150-day assessment, a rolling review procedure and an innovative licensing and access pathway, or ILAP. ILAP aims to accelerate the time to market and to facilitate patient access to medicines, including new chemical entities, biological medicines, new indications and repurposed medicines. To benefit from ILAP, Homology must first apply to the MHRA for an innovation passport. An innovation passport allows for enhanced engagement with the MHRA and its partner agencies. Once an innovation passport has been granted, the next step in the pathway is the preparation of a target development profile, or TDP, document by the MHRA and its partner agencies. The TDP sets out the regulatory and development milestones, identifies potential pitfalls and creates a roadmap to achieving early patient access in the UK. Product developers that benefit from ILAP will be provided with advice on clinical trial design to ensure optimal data generation for both regulatory approval and health technology appraisal.

The competent regulatory authorities in the EU and the UK have broad discretion whether to grant access to the aforementioned schemes and designations, and even if Homology were to be eligible for some of these procedures, it may not experience a faster development process, review or authorization compared to conventional procedures. Moreover, the removal or threat of removal of such designation may create uncertainty or delay in the clinical development of Homology’s product candidates and threaten the commercialization prospects of its product candidates, if approved. Such an occurrence could materially impact Homology’s business, financial condition and results of operations.

Should Homology resume development of its product candidates, it may attempt to secure approval from the FDA or comparable foreign regulatory authorities through the use of accelerated approval pathways or similar expedited approval pathways outside the United States. If Homology is unable to obtain such approval, it may be required to conduct additional clinical trials beyond those that it contemplates, which could increase the expense of obtaining, and delay the receipt of, necessary marketing approvals. Even if Homology receives accelerated approval from the FDA or similar expedited approval pathways by foreign regulatory authorities, if its confirmatory trials do not verify clinical benefit, or if it does not comply with rigorous post-marketing requirements, the FDA or foreign regulatory authorities may seek to withdraw accelerated approval or similar expedited approval.

To the extent Homology resumes development of its product candidates, it may in the future seek an accelerated approval for one or more of its product candidates. Under the accelerated approval program, the FDA may grant accelerated approval to a product candidate designed to treat a serious or life-threatening condition that provides meaningful therapeutic benefit over available therapies upon a determination that the product candidate has an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit. The FDA considers a clinical benefit to be a positive therapeutic effect that is clinically meaningful in the context of a given disease, such as irreversible morbidity or mortality. For the purposes of

 

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accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. An intermediate clinical endpoint is a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.

The accelerated approval pathway may be used in cases in which the advantage of a drug or biologic over available therapy may not be a direct therapeutic advantage, but is a clinically important improvement from a patient and public health perspective. If granted, accelerated approval is usually contingent on the sponsor’s agreement to conduct, in a diligent manner, confirmatory studies to verity and describe the drug or biologic’s predicted clinical benefit. Under the Food and Drug Omnibus Reform Act of 2022, or FDORA, the FDA is permitted to require, as appropriate, that a post-approval confirmatory study or studies be underway prior to approval or within a specified time period after the date of accelerated approval was granted. FDORA also requires sponsors to send updates to the FDA every 180 days on the status of such studies, including progress toward enrollment targets, and the FDA must promptly post this information publicly. FDORA also gives the FDA increased authority to withdraw approval of a drug or biologic granted accelerated approval on an expedited basis, if the sponsor fails to conduct such studies in a timely manner, send the necessary updates to the FDA, or if confirmatory studies fail to confirm such clinical benefit.

In the EU, a “conditional” marketing authorization may be granted in cases where all the required safety and efficacy data are not yet available. A conditional marketing authorization is subject to conditions to be fulfilled for generating missing data or ensuring increased safety measures. A conditional marketing authorization is valid for one year and has to be renewed annually until fulfillment of all relevant conditions. Once the applicable pending studies are provided, a conditional marketing authorization can become a “standard” marketing authorization. However, if the conditions are not fulfilled within the timeframe set by the EMA, the marketing authorization will cease to be renewed. Furthermore, marketing authorizations may also be granted “under exceptional circumstances” when the applicant can show that it is unable to provide comprehensive data on the efficacy and safety under normal conditions of use even after the product has been authorized and subject to the introduction of specific procedures. This may arise when the intended indications are very rare and, in the present state of scientific knowledge, it is not possible to provide comprehensive information, or when generating data may be contrary to generally accepted ethical principles. This type of marketing authorization is close to a conditional marketing authorization as it is reserved to medicinal products to be approved for severe diseases or unmet medical needs and the applicant does not hold the complete data set legally required for the grant of a marketing authorization. However, unlike a conditional marketing authorization, the applicant does not have to provide the missing data and will never have to. Although a marketing authorization “under exceptional circumstances” is granted definitively, the risk-benefit balance of the medicinal product is reviewed annually and the marketing authorization may be withdrawn where the risk-benefit ratio is no longer favorable.

Prior to seeking accelerated approval or similar expedited approval for any of its product candidates, should Homology resume development of its product candidates, Homology may seek feedback from the FDA or other comparable regulatory authorities and will otherwise evaluate its ability to seek and receive accelerated approval or similar expedited approval. Furthermore, if Homology decides to submit an application for accelerated approval or similar expedited approval, there can be no assurance that such submission or application will be accepted or that any expedited development, review or approval will be granted on a timely basis, or at all. The FDA or other comparable foreign regulatory authorities could also require Homology to conduct further studies prior to considering its application or granting approval of any type. A failure to obtain accelerated approval or any other form of expedited development, review or approval for Homology’s product candidate would result in a longer time period to commercialization of such product candidate, or make commercialization unfeasible, and could increase the cost of development of such product candidate and could harm Homology’s competitive position in the marketplace.

 

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Homology may seek orphan drug designation for its product candidates should it resume its development activities in the future, but any orphan drug designations Homology may receive may not confer marketing exclusivity or other expected benefits.

In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers. In addition, if a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan drug exclusivity. Orphan drug exclusivity in the United States provides that the FDA may not approve any other applications, including a full BLA, to market the same drug for the same disease or condition for seven years, except in limited circumstances. The applicable exclusivity period is ten years in the EU. The European exclusivity period can be reduced to six years if, at the end of the fifth year, a drug no longer meets the criteria for orphan drug designation or if the drug is sufficiently profitable so that market exclusivity is no longer justified.

In the future, even if Homology, or any prospective collaborators, obtain orphan drug designation for a product candidate, Homology, or they, may not be able to obtain or maintain orphan drug exclusivity for that product candidate. Homology may not be the first to obtain marketing approval of any product candidate for which Homology has obtained orphan drug designation for the orphan-designated disease or condition due to the uncertainties associated with developing pharmaceutical products. In addition, exclusive marketing rights in the United States may be limited if Homology seeks approval for a disease or condition broader than the orphan-designated disease or condition or may be lost if the FDA later determines that the request for designation was materially defective or if Homology is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition. Further, even if Homology, or any future collaborators, obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different drugs with different active moieties may be approved for the same disease or condition. Even after an orphan drug is approved, the FDA can subsequently approve the same drug for the same disease or condition if the FDA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care or the manufacturer of the product with orphan exclusivity is unable to maintain sufficient product quantity. Orphan drug designation neither shortens the development time or regulatory review time of a drug nor gives the drug any advantage in the regulatory review or approval process, nor does it prevent competitors from obtaining approval of the same product candidate as Homology’s for diseases or conditions other than those in which Homology has been granted orphan drug designation. The same principles are valid for the EU as well.

A Regenerative Medicine Advanced Therapy designation from the FDA, or Advanced Therapy Medicinal Product classification by the EMA, even if granted for any of Homology’s product candidates, may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that Homology’s product candidates will receive marketing approval.

Should Homology resume development of its product candidates, Homology may seek a Regenerative Medicine Advanced Therapy, or RMAT, designation for HMI-102 or its product candidates. In 2017, the FDA established the RMAT designation as part of its implementation of the 21st Century Cures Act. An investigational drug is eligible for RMAT designation if: (1) it meets the definition of a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, with limited exceptions; (2) it is intended to treat, modify, reverse, or cure a serious disease or condition; and (3) preliminary clinical evidence indicates that the investigational drug has the potential to address unmet medical needs for such disease or condition. In a February 2019 final guidance, the FDA also stated that certain gene therapies that lead to a sustained effect on cells or tissues may meet the definition of a regenerative medicine therapy. RMAT designation provides potential benefits that include more frequent meetings with FDA to discuss the development plan for the product candidate, and eligibility for rolling review of BLAs and priority review. Product candidates granted RMAT designation may also be eligible for accelerated approval on the basis of a surrogate or intermediate endpoint

 

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reasonably likely to predict long-term clinical benefit, or reliance upon data obtained from a meaningful number of sites, including through expansion to additional sites, as appropriate. RMAT-designated product candidates that receive accelerated approval may, as appropriate, fulfill their post-approval requirements through the submission of clinical evidence, clinical studies, patient registries, or other sources of real world evidence (such as electronic health records); through the collection of larger confirmatory data sets; or via post-approval monitoring of all patients treated with such therapy prior to approval of the therapy.

RMAT designation does not change the standards for product approval, and there is no assurance that such designation or eligibility for such designation will result in expedited review or approval or that the approved indication will not be narrower than the indication covered by the RMAT designation. Additionally, RMAT designation can be revoked if the criteria for eligibility cease to be met as clinical data emerges.

In the EU, a specific framework has been implemented for ATMPs to facilitate their access to the EU market. An ATMP can be classified into three main types of medicinal products: (i) gene therapy medicinal products containing genes that lead to a therapeutic, prophylactic or diagnostic effect, (ii) somatic-cell therapy medicinal products containing cells or tissues that have been manipulated to change their biological characteristics or cells or tissues not intended to be used for the same essential functions in the body which can be used to cure, diagnose or prevent diseases, and (iii) tissue-engineered products containing cells or tissues that have been modified so they can be used to repair, regenerate or replace human tissue. Companies developing product candidates may seek a scientific recommendation from the EMA’s CAT on ATMP classification. This optional procedure allows applicants to clarify whether a given product candidate based on genes, cells or tissues meets the scientific criteria which define ATMPs, in order to address, as early as possible, questions of borderline with other areas, which may arise as science develops. ATMP classification recommendation is adopted by the EMA’s CAT, after consultation with the EC. The EMA offers a range of advisory services and incentives to support the development of ATMPs such as contribution of the CAT’s members in the discussion of the scientific advice and fee waivers. Similarly to RMAT designation, ATMP classification in the EU does not change the standards for product approval, and there is no assurance that such classification will result in expedited review or approval.

Homology’s contract manufacturers, including Oxford Biomedica Solutions LLC, are subject to significant regulation with respect to manufacturing its former product candidates. The manufacturing facilities which Homology has historically and may in the future rely may not meet or continue to meet regulatory requirements, as applicable and as imposed to date, and have limited capacity.

Historically, Homology has had relationships with a limited number of suppliers for the manufacturing of its viral vectors and product candidates. In March 2022, Homology closed an agreement with Oxford to establish a new AAV vector manufacturing company, Oxford Biomedica Solutions LLC, that incorporates Homology’s proven ‘plug and play’ process development and manufacturing platform, as well as its experienced team and high-quality GMP vector production capabilities that Homology built and operated since 2019. The related transactions closed on March 10, 2022. Each supplier may require licenses to manufacture such components if such processes are not owned by the supplier or in the public domain and Homology may be unable to transfer or sublicense the intellectual property rights it may have with respect to such activities.

All entities involved in the preparation of therapeutics for clinical studies or commercial sale, including Homology’s existing contract manufacturers for its product candidates, are subject to extensive regulation. Components of a finished therapeutic product approved for commercial sale or used in late-stage clinical studies must be manufactured in accordance with GMP or similar requirements outside the United States. These regulations govern manufacturing processes and procedures (including record keeping) and the implementation and operation of quality systems to control and assure the quality of investigational products and products approved for sale. Poor control of production processes can lead to the introduction of adventitious agents or other contaminants, or to inadvertent changes in the properties or stability of Homology’s product candidates that may not be detectable in final product testing. Homology’s contract manufacturers must supply all necessary

 

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documentation in support of a BLA on a timely basis and must adhere to the FDA’s current good laboratory practices, or GLP, and GMP regulations enforced by the FDA through its facilities inspection program. Similar requirements apply in foreign jurisdictions. Some of Homology’s contract manufacturers have not produced a commercially-approved product and therefore have not obtained the requisite FDA and foreign regulatory approvals to do so. Homology’s facilities and quality systems and the facilities and quality systems of some or all of its third-party contractors must pass a pre-approval inspection for compliance with the applicable regulations as a condition of regulatory approval of its product candidates or any of its other potential products. In addition, the regulatory authorities may, at any time, audit or inspect a manufacturing facility involved with the preparation of Homology’s product candidates or its other potential products or the associated quality systems for compliance with the regulations applicable to the activities being conducted. If these facilities do not pass a pre-approval plant inspection, FDA or foreign regulatory authorities approval of the products will not be granted.

The regulatory authorities also may, at any time following approval of a product for sale, audit Homology’s manufacturing facilities or those of its third-party contractors. If any such inspection or audit identifies a failure to comply with applicable regulations or if a violation of Homology’s product specifications or applicable regulations occurs independent of such an inspection or audit, Homology or the relevant regulatory authority may require remedial measures that may be costly and/or time-consuming for Homology or a third party to implement and that may include the temporary or permanent suspension of a clinical study or commercial sales or the temporary or permanent closure of a facility. Any such remedial measures imposed upon Homology or third parties with whom Homology contracts could materially harm its business.

If Homology’s third-party manufacturers fail to maintain regulatory compliance, the FDA or other regulatory authorities can impose regulatory sanctions including, among other things, refusal to approve a pending application for a new drug product or biologic product, or revocation of a pre-existing approval. As a result, Homology’s business, financial condition and results of operations may be materially harmed.

Additionally, if supply from one approved manufacturer is interrupted, there could be a significant disruption in commercial supply. An alternative manufacturer would need to be qualified through a BLA supplement and/or marketing authorization application supplement which could result in further delay. The regulatory agencies may also require additional studies if a new manufacturer is relied upon for commercial production. Switching manufacturers may involve substantial costs and is likely to result in a delay in Homology’s desired clinical and commercial timelines.

These factors could cause the delay of clinical studies, regulatory submissions, required approvals or commercialization of Homology’s product candidates, cause Homology to incur higher costs and prevent Homology from commercializing its products successfully. Furthermore, if its suppliers fail to meet contractual requirements, and Homology is unable to secure one or more replacement suppliers capable of production at a substantially equivalent cost, its clinical studies may be delayed or Homology could lose potential revenue.

If Homology resumes development of product candidates and encounters difficulties enrolling patients in its clinical trials, Homology’s clinical development activities could be delayed or otherwise adversely affected.

Should Homology resume development of its product candidates, the timely completion of clinical trials would depend, among other things, on its ability to enroll a sufficient number of patients who remain in the study until its conclusion. Homology may encounter delays in enrolling, or be unable to enroll, a sufficient number of patients to complete any of its clinical trials, and even once enrolled Homology may be unable to retain a sufficient number of patients to complete any of its trials. The enrollment of patients depends on many factors, including:

 

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the patient eligibility criteria defined in the protocol;

 

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the size of the patient population required for analysis of the trial’s primary endpoints;

 

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the proximity of patients to study sites;

 

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the design of the trial;

 

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Homology’s ability to recruit clinical trial investigators with the appropriate competencies and experience;

 

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clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new products that may be approved for the indications Homology is investigating;

 

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Homology’s ability to obtain and maintain patient consents; and

 

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the risk that patients enrolled in clinical trials will drop out of the trials before completion.

In addition, should Homology resume development of its product candidates, its clinical trials would compete with other clinical trials for product candidates that are in the same therapeutic areas as its product candidates, and this competition would reduce the number and types of patients available to Homology, because some patients who might have opted to enroll in its trials may instead opt to enroll in a trial being conducted by one of its competitors. Since the number of qualified clinical investigators is limited, Homology would expect to conduct some of its clinical trials at the same clinical trial sites that some of its competitors use, which would reduce the number of patients who are available for Homology’s clinical trials in such clinical trial site.

Delays or failures in planned patient enrollment or retention may result in increased costs, program delays or both, which could have a harmful effect on Homology’s ability to develop its product candidates, or could render further development impossible.

Homology’s product candidates have caused and may in the future cause serious adverse events or undesirable side effects or have other properties which may delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following marketing approval, if any.

Serious adverse events or undesirable side effects caused by Homology’s product candidates have caused, and could in the future cause, Homology or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign authorities. Results of Homology’s clinical trials could reveal a high and unacceptable severity and prevalence of side effects, toxicities or unexpected characteristics, including death. A significant risk in any gene editing product is that the edit will be “off-target” (or “on-target,” but unwanted) and cause serious adverse events, undesirable side effects, toxicities or unexpected characteristics. For example, off-target cuts could lead to disruption of a gene or a genetic regulatory sequence at an unintended site in the DNA, or, in those instances where Homology also provides a segment of DNA to serve as a repair template, it is possible that following off-target cut events, DNA from such repair template could be integrated into the genome at an unintended site, potentially disrupting another important gene or genomic element. Homology cannot be certain that off-target editing will not occur in any of its planned or future clinical studies. There is also the potential risk of delayed adverse events following exposure to gene editing and/or gene therapy, due to the potential for persistent biological activity of the genetic material or other product components used to carry the genetic material. Accordingly, the FDA typically recommends an extended follow-up period to monitor for such events in patients who have received investigational gene therapies. Although Homology has communicated to FDA its intent to withdraw or inactive its previously open INDs and discontinue development of its product candidates, as well as its determination that such long-term follow-up is not necessary for its product candidates, FDA may disagree, and may continue to recommend that such follow-up be conducted.

If Homology resumes development of its product candidates and unacceptable side effects arise in the development of such product candidates, Homology, the FDA, the IRBs at the institutions in which Homology’s studies are conducted or DMC, could suspend or terminate Homology’s clinical trials or the FDA or comparable foreign regulatory authorities could order Homology to cease clinical trials or deny approval of Homology’s

 

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product candidates for any or all targeted indications. Treatment-related side effects could also affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. In addition, these side effects may not be appropriately recognized or managed by the treating medical staff. Homology expects to have to train medical personnel using Homology’s product candidates to understand the side effect profiles for its clinical trials and upon any commercialization of any of its product candidates. Inadequate training in recognizing or managing the potential side effects of Homology’s product candidates could result in patient injury or death. Any of these occurrences may harm Homology’s business, financial condition and prospects significantly.

If Homology resumes development of its product candidates and any of its product candidates receives marketing approval, and Homology or others later identify undesirable side effects caused by any such product, including during any long-term follow-up observation period recommended or required for patients who receive treatment using Homology’s products, a number of potentially significant negative consequences could result, including:

 

  •  

regulatory authorities may withdraw approvals of such product;

 

  •  

Homology may be required to recall a product or change the way such product is administered to patients;

 

  •  

additional restrictions may be imposed on the marketing of the particular product or the manufacturing processes for the product;

 

  •  

regulatory authorities may require additional warnings on the label, such as a “black box” warning or contraindication;

 

  •  

Homology may be required to implement a Risk Evaluation and Mitigation Strategy, or REMS, or create a medication guide outlining the risks of such side effects for distribution to patients or implement similar risk management measures;

 

  •  

the product could become less competitive;

 

  •  

Homology could be sued and held liable for harm caused to patients; and

 

  •  

Homology’s reputation may suffer.

Any of these events could prevent Homology from achieving or maintaining market acceptance of the particular product candidate, if approved, and could significantly harm its business, results of operations and prospects.

The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable.

The time required to obtain approval by the FDA and comparable foreign authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions. Homology has not obtained regulatory approval for any product candidate and has communicated to FDA its intent to withdraw or inactivate its previously open INDs. It is possible that neither Homology’s product candidates previously in development (should Homology elect to restart its development programs), nor any other product candidates Homology may seek to develop in the future will ever obtain regulatory approval. Neither Homology nor any future collaborator is permitted to market any of Homology’s product candidates in the United States until Homology receives regulatory approval of a BLA from the FDA. It is possible that the FDA may refuse to file for substantive review any BLAs, that Homology submits for its product candidates or may conclude after review of Homology’s data that its application is insufficient to obtain marketing approval of its product candidates. Similar risks exist in foreign jurisdictions.

 

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Prior to obtaining approval to commercialize a product candidate in the United States or abroad, Homology or its collaborators must demonstrate with substantial evidence from well-controlled clinical trials, and to the satisfaction of the FDA or foreign regulatory authorities, that such product candidates are safe and effective, or in the case of biologics, safe, pure, and potent, for their intended uses. Results from nonclinical studies and clinical trials can be interpreted in different ways. Even if Homology believes the nonclinical or clinical data for its product candidates are promising, such data may not be sufficient to support approval by the FDA and other regulatory authorities. The FDA and other regulatory authorities may also require Homology to conduct additional preclinical studies or clinical trials for Homology’s product candidates either prior to or post-approval, or it may object to elements of Homology’s clinical development program. Depending on the extent of these or any other FDA- and other regulatory authorities- required studies, approval of any BLA or application that Homology submits may be delayed by several years, or may require Homology to expend significantly more resources than Homology has available.

Of the large number of potential products in development, only a small percentage successfully complete the FDA or foreign regulatory approval processes and are commercialized. The lengthy approval process as well as the unpredictability of future clinical trial results may result in Homology’s failing to obtain regulatory approval to market its product candidates, which would significantly harm Homology’s business, results of operations and prospects.

In addition, even if Homology were to obtain approval, regulatory authorities may approve any of Homology’s product candidates for fewer or more limited indications than Homology requests, may not approve the price Homology intends to charge for its products, may grant approval contingent on the performance of costly post-marketing clinical trials, including Phase 4 clinical trials, and/or the implementation of a REMS or similar risk management measures, which may be required to ensure safe use of the drug after approval. The FDA or the applicable foreign regulatory agency also may approve a product candidate for a more limited indication or patient population than Homology originally requested, or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Any of the foregoing scenarios could materially harm the commercial prospects for Homology’s product candidates.

In addition, changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted product application, may cause delays in the approval or rejection of an application. For instance, the EU pharmaceutical legislation is currently undergoing a complete review process, in the context of the Pharmaceutical Strategy for Europe initiative, launched by the EC in November 2020. The EC’s proposal for revision of several legislative instruments related to medicinal products (including potentially revising the duration of regulatory exclusivity and eligibility for expedited pathways) was published on April 26, 2023. The proposed revisions remain to be agreed and adopted by the European Parliament and European Council (not expected before the end of 2024 or early 2025). The revisions may, however, have a significant impact on the pharmaceutical industry and Homology’s business in the long term.

Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact Homology’s business to the extent Homology resumes such activities.

The ability of the FDA and foreign regulatory authorities to review and or approve new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy changes, the FDA’s or and foreign regulatory authorities’ ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s or foreign regulatory authorities’ ability to perform routine functions. Average review times at the agency and foreign regulatory authorities have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund

 

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research and development activities is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA and other agencies, such as the EMA following its relocation to Amsterdam and related reorganization, may also slow the time necessary for new drugs and biologics to be reviewed and/or approved by necessary government agencies, which would adversely affect Homology’s business. For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities.

Even if Homology restarts development of its product candidates and obtains FDA approval for its product candidates in the United States in the future, it may never obtain approval for or commercialize them in any other jurisdiction, which would limit its ability to realize their full market potential.

In order to market any products in any particular jurisdiction, Homology must establish and comply with numerous and varying regulatory requirements on a country-by-country basis regarding safety and efficacy. Approval by the FDA in the United States does not ensure approval by regulatory authorities in other countries or jurisdictions. However, the failure to obtain approval in any one jurisdiction may negatively impact Homology’s ability to obtain approval elsewhere. In addition, clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not guarantee regulatory approval in any other country.

Approval processes vary among countries and can involve additional product testing and validation and additional administrative review periods. Seeking foreign regulatory approval could result in difficulties and increased costs for Homology and require additional preclinical studies or clinical trials which could be costly and time consuming. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of Homology’s products in those countries. Homology does not have any product candidates approved for sale in any jurisdiction, including in international markets, and it does not have experience in obtaining regulatory approval in international markets. If Homology fails to comply with regulatory requirements in international markets or to obtain and maintain required approvals, or if regulatory approvals in international markets are delayed, its target market will be reduced and its ability to realize the full market potential of any product it develops will be unrealized.

Even if Homology restarts development of and receives regulatory approval of its product candidates, Homology will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense, and it may be subject to penalties if it fails to comply with regulatory requirements or experience unanticipated problems with its product candidates.

Any product candidate for which Homology obtains marketing approval will be subject to extensive and ongoing requirements of and review by the FDA and other regulatory authorities, including oversight of the manufacturing processes, post-approval clinical data, labeling, packaging, distribution, adverse event reporting, storage, recordkeeping, export, import, advertising and promotional activities for such product, among other things. These requirements include submissions of safety and other post-marketing information and reports, establishment registration and drug listing requirements, continued compliance with GMP requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents, requirements regarding the distribution of samples to physicians and recordkeeping and GCP requirements for any clinical trials that Homology conducts post-approval. Manufacturers of drug products and their facilities are subject to continual review and periodic, unannounced inspections by the FDA and other regulatory authorities for compliance with GMP or similar regulations and standards.

In addition, any marketing approvals that Homology may receive for its product candidates may contain significant limitations related to use restrictions for specified age groups, warnings, precautions or contraindications, and may include burdensome post-approval study or risk management requirements. For example, the FDA may require a REMS in order to approve Homology’s product candidates, which could entail requirements for a medication guide, physician training and communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.

 

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In addition, later discovery of previously unknown adverse events or other problems with Homology’s products, manufacturers or manufacturing processes, including adverse events of unanticipated severity or frequency, or with Homology’s third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may yield various results, including:

 

  •  

restrictions on manufacturing such products;

 

  •  

restrictions on the labeling or marketing of a product;

 

  •  

restrictions on product distribution or use;

 

  •  

requirements to conduct post-marketing studies or clinical trials;

 

  •  

warning letters or holds on clinical trials;

 

  •  

withdrawal of the products from the market;

 

  •  

refusal to approve pending applications or supplements to approved applications that Homology submits;

 

  •  

recall of products;

 

  •  

fines, restitution or disgorgement of profits or revenues;

 

  •  

suspension or withdrawal of marketing approvals;

 

  •  

refusal to permit the import or export of Homology’s products;

 

  •  

product seizure or detention; or

 

  •  

injunctions or the imposition of civil or criminal penalties.

The FDA’s and other regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of Homology’s product candidates.

Homology also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If Homology is slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if Homology is not able to maintain regulatory compliance, it may be subject to enforcement action and it may not achieve or sustain profitability.

The FDA and other regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses.

If Homology restarts development of its product candidates and any of Homology’s product candidates are approved, and if Homology is found to have improperly promoted off-label uses of those products, Homology may become subject to significant liability. The FDA and other regulatory authorities strictly regulate the promotional claims that may be made about prescription products, such as Homology’s product candidates, if approved. In particular, a product may not be promoted for uses that are not approved by the FDA or such other regulatory agencies as reflected in the product’s approved labeling. If Homology receives marketing approval for a product candidate, physicians may nevertheless prescribe it to their patients in a manner that is inconsistent with the approved label. If Homology is found to have promoted such off-label uses, it may become subject to significant liability. The U.S. federal government has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. If Homology cannot successfully manage the promotion of its product candidates, if approved, Homology could become subject to significant liability, which would materially adversely affect its business and financial condition.

 

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Potential product liability lawsuits against Homology could cause it to incur substantial liabilities and limit commercialization of any products that it may develop.

The use of Homology’s product candidates in clinical trials and the sale of any products for which Homology obtains marketing approval exposes it to the risk of product liability claims. Product liability claims might be brought against Homology by consumers, healthcare providers, pharmaceutical companies or others selling or otherwise coming into contact with its products. On occasion, large judgments have been awarded in class action lawsuits based on products that had unanticipated adverse effects. If Homology cannot successfully defend against product liability claims, it could incur substantial liability and costs. In addition, regardless of merit or eventual outcome, product liability claims may result in:

 

  •  

impairment of Homology’s business reputation and significant negative media attention;

 

  •  

withdrawal of participants from Homology’s clinical trials;

 

  •  

significant costs to defend the related litigation and related litigation;

 

  •  

distraction of management’s attention from Homology’s primary business;

 

  •  

substantial monetary awards to patients or other claimants;

 

  •  

inability to commercialize Homology’s product candidates;

 

  •  

product recalls, withdrawals or labeling, marketing or promotional restrictions;

 

  •  

decreased demand for Homology’s product candidates, if approved for commercial sale; and

 

  •  

loss of revenue.

Homology’s insurance policies are expensive and protect Homology only from some business risks, which leaves it exposed to significant uninsured liabilities.

Homology does not carry insurance for all categories of risk that its business may encounter. Some of the policies Homology currently maintains include general liability, employment practices liability, property, auto, workers’ compensation, umbrella, and directors’ and officers’ insurance.

Any additional product liability insurance coverage Homology acquires in the future, may not be sufficient to reimburse Homology for any expenses or losses it may suffer. Moreover, insurance coverage is becoming increasingly expensive and in the future Homology may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect it against losses due to liability. If Homology obtains marketing approval for any of its product candidates, Homology intends to acquire insurance coverage to include the sale of commercial products; however, Homology may be unable to obtain product liability insurance on commercially reasonable terms or in adequate amounts. A successful product liability claim or series of claims brought against Homology could cause its share price to decline and, if judgments exceed its insurance coverage, could adversely affect its results of operations and business, including preventing or limiting the commercialization of any product candidates it develops. Homology does not carry specific biological or hazardous waste insurance coverage, and its property, casualty and general liability insurance policies specifically exclude coverage for damages and fines arising from biological or hazardous waste exposure or contamination. Accordingly, in the event of contamination or injury, Homology could be held liable for damages or be penalized with fines in an amount exceeding its resources, and its clinical trials or regulatory approvals could be suspended.

Homology also expects that operating as a public company will continue to make it more expensive for it to obtain director and officer liability insurance, and Homology may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a result, it may be more difficult for Homology to attract and retain qualified people to serve on its board of directors, its board committees or as executive officers. Homology does not know if it will be able to maintain existing insurance with adequate levels of coverage. Any significant uninsured liability may require Homology to pay substantial amounts, which would adversely affect its cash position and results of operations.

 

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Homology’s employees and independent contractors, including principal investigators, CROs, consultants, vendors, and any third parties Homology may engage in connection with development and commercialization, to the extent Homology resumes such activities, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on Homology’s business.

Misconduct by Homology’s employees and independent contractors, including principal investigators, CROs, consultants, vendors, and any third parties Homology may engage in connection with development and commercialization, could include intentional, reckless or negligent conduct or unauthorized activities that violate: (i) the laws and regulations of the FDA, foreign regulatory authorities rules and regulations and other similar regulatory requirements, including those laws that require the reporting of true, complete and accurate information to such authorities; (ii) manufacturing standards; or (iii) data privacy, security, fraud and abuse and other healthcare laws and regulations. Specifically, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Activities subject to these laws could also involve the improper use or misrepresentation of information obtained in the course of clinical trials, creation of fraudulent data in preclinical studies or clinical trials or illegal misappropriation of drug product, which could result in regulatory sanctions and cause serious harm to Homology’s reputation. It is not always possible to identify and deter misconduct by employees and other third parties, and the precautions Homology takes to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting it from governmental investigations or other actions or lawsuits stemming from a failure to comply with such laws or regulations. Additionally, Homology is subject to the risk that a person or government could allege such fraud or other misconduct, even if none occurred. If any such actions are instituted against Homology, and Homology is not successful in defending ourselves or asserting its rights, those actions could have a significant impact on Homology’s business and results of operations, including the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, disgorgements, possible exclusion from participation in Medicare, Medicaid, other U.S. federal healthcare programs or healthcare programs in other jurisdictions, individual imprisonment, other sanctions, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of Homology’s operations.

Homology’s business and operations may suffer in the event of information technology system failures, cyberattacks or deficiencies in its cybersecurity.

In the ordinary course of its business, Homology collects and store sensitive data, including intellectual property, clinical trial data, proprietary business information, personal data and personally identifiable information of its clinical trial subjects and employees, in its data centers and on its networks. The secure processing, maintenance and transmission of this information is critical to Homology’s operations. Homology’s information technology systems, as well as those of its CROs and other contractors and consultants, are vulnerable to failure or damage from computer viruses and malware (e.g. ransomware), unauthorized access or other cybersecurity attacks, natural disasters (including hurricanes), international terrorism and conflicts, and telecommunication and electrical failures. Homology and certain of its service providers are from time to time subject to cyberattacks and security incidents. While Homology does not believe that it has experienced any significant system failure, accident or security breach to date, if such an event were to occur and cause interruptions in its operations, it could result in a material disruption of Homology’s product candidate development programs. For example, should Homology resume the development of its product candidates, the loss of preclinical or clinical trial data from completed, ongoing or planned trials could result in delays in Homology’s regulatory approval efforts and significantly increase its costs to recover or reproduce the data. To the extent that any disruption or security breach were to result in a loss of or damage to Homology’s data or applications, or inappropriate disclosure of personal, confidential or proprietary information, Homology could incur liability and the further development of its product candidates could be delayed.

 

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Despite Homology’s security measures, its information technology and infrastructure may be vulnerable to attacks by hackers or internal bad actors, or breached due to human error (e.g., social engineering, phishing), a technical vulnerability, malfeasance or other disruptions. Attacks upon information technology systems are increasing in their frequency, levels of persistence, sophistication and intensity, and are being conducted by sophisticated and organized groups and individuals with a wide range of motives and expertise.

Homology may also face cybersecurity risks due to its reliance on internet technology and the number of its employees who are working remotely, which may create additional opportunities for cybercriminals to exploit vulnerabilities. Even if identified, Homology may be unable to adequately investigate or remediate incidents or breaches due to attackers increasingly using tools and techniques (including artificial intelligence) that are designed to circumvent controls, to avoid detection, and to remove or obfuscate forensic evidence. Any significant security breach could compromise Homology’s networks and the information stored there could be accessed, publicly disclosed, lost or stolen. Any such access, disclosure or other loss of information could require significant resources to remediate or recover from the incident, result in legal claims or proceedings (including class actions), liability under laws that protect the privacy of personal information, significant regulatory penalties, and such an event could disrupt Homology’s operations, damage its reputation, and cause a loss of confidence in Homology and its ability to conduct clinical trials, which could adversely affect Homology’s reputation and delay its clinical development of its product candidates. Further, Homology’s insurance coverage may not be sufficient to cover the financial, legal, business or reputational losses that may result from an interruption or breach of its systems.

Should Homology resume development of its product candidates, initial, interim, “top-line” and preliminary data from its clinical trials that it announces or publishes from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

If Homology resumes development of product candidates it may publicly disclose initial, interim, top-line or preliminary data from its clinical trials, which would be based on a preliminary analysis of then-available data, and the results and related findings and conclusions would be subject to change following a more comprehensive review of the data related to the particular study or trial. Homology also makes assumptions, estimations, calculations and conclusions as part of its analyses of data, and it may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the initial, top-line or preliminary results that Homology reports may differ from future results of the same studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Initial, top-line or preliminary data also remain subject to audit and verification procedures that may result in the final data being materially different from the initial, top-line or preliminary data Homology previously published. Should Homology resume development of its product candidates, further clinical data from any trials of its candidates may not be consistent with data previously observed and disclosed in preclinical studies or clinical trials. As a result, initial, top-line and preliminary data should be viewed with caution until the final data are available.

Homology may also disclose interim or initial data from its preclinical studies and clinical trials. Interim or initial data from clinical trials that Homology may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Adverse differences between initial, interim, top-line or preliminary data and final data could significantly harm Homology’s business prospects. Further, disclosure of any such data by Homology or by its competitors could result in volatility in the price of its common stock.

Further, others, including regulatory agencies, may not accept or agree with Homology’s assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular

product candidate or product and Homology in general. In addition, the information Homology chooses to

 

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publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what Homology determines is material or otherwise appropriate information to include in its disclosure.

If the top-line or preliminary data that Homology reports differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, Homology’s ability to obtain approval for, and commercialize, its product candidates may be harmed, which could harm its business, operating results, prospects or financial condition.

To the extent Homology resumes development of its product candidates, it may expend its limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.

Because Homology has limited financial and managerial resources, Homology has focused on research programs and product candidates that it identifies for specific indications. As a result, Homology may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential. Homology’s resource allocation decisions may cause Homology to fail to timely capitalize on viable commercial products or profitable market opportunities. Homology’s spending on current and future research and development programs and product candidates for specific indications may not yield any commercially viable products. If Homology does not accurately evaluate the commercial potential or target market for a particular product candidate, Homology may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for Homology to retain sole development and commercialization rights to such product candidate.

Risks Related to Healthcare Laws and Other Legal Compliance Matters

If Homology resumes development of its product candidates, enacted and future healthcare legislation could increase the difficulty and cost for Homology to obtain marketing approval of and commercialize its product candidates and may affect the prices Homology may set.

In the United States, the EU and other jurisdictions, there have been, and Homology expects there will continue to be, a number of legislative and regulatory changes and proposed changes to the healthcare system that could affect Homology’s future results of operations. In particular, there have been and continue to be a number of initiatives at the U.S. federal and state levels that seek to reduce healthcare costs and improve the quality of healthcare. For example, in 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively the ACA, was enacted, which substantially changed the way healthcare is financed by both governmental and private insurers. Among the provisions of the ACA, those of greatest importance to the pharmaceutical and biotechnology industries include the following:

 

  •  

an annual, non-deductible fee payable by any entity that manufactures or imports certain branded prescription drugs and biologic agents (other than those designated as orphan drugs), which is apportioned among these entities according to their market share in certain government healthcare programs;

 

  •  

a Medicare Part D coverage gap discount program, in which manufacturers must agree to offer point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;

 

  •  

an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13.0% of the average manufacturer price for branded and generic drugs, respectively;

 

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extension of a manufacturer’s Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;

 

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  •  

expansion of eligibility criteria for Medicaid, thereby potentially increasing a manufacturer’s Medicaid rebate liability; and

 

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a Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.

In addition, other legislative changes have been proposed and adopted in the United States since the ACA was enacted. For example, the Budget Control Act of 2011 resulted in aggregate reductions of Medicare payments to providers, which went into effect in April 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2031, unless additional action is taken by Congress. In January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. These new laws or any other similar laws introduced in the future may result in additional reductions in Medicare and other healthcare funding, which could negatively affect Homology’s customers and accordingly, its financial operations.

Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives. For example, CMS may develop new payment and delivery models, such as bundled payment models. On March 11, 2021, the American Rescue Plan Act of 2021 was signed into law, which eliminates the statutory cap on the Medicaid drug rebate, currently set at 100% of a drug’s AMP, beginning January 1, 2024.

In addition, recently there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products. On August 16, 2022, the Inflation Reduction Act of 2022, or IRA, was signed into law. Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), with prices that can be negotiated subject to a cap; imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023); and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025). The IRA permits the Secretary of the Department of Health and Human Services (HHS) to implement many of these provisions through guidance, as opposed to regulation, for the initial years. Further, under the IRA, orphan drugs are exempted from the Medicare drug price negotiation program, but only if they have one orphan designation and for which the only approved indication is for that disease or condition. If a product receives multiple orphan designations or has multiple approved indications, it may not qualify for the orphan drug exemption. The implementation of the IRA is currently subject to ongoing litigation challenging the constitutionality of the IRA’s Medicare drug price negotiation program. The impact of the IRA on Homology’s business and the pharmaceutical industry cannot yet be fully determined, but it could have a significant impact. In particular, if a product becomes subject to the IRA negotiation provision and related price cap, that may significantly alter the economic rationale for developing and commercializing a biosimilar. Homology expects that additional U.S. federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that the U.S. federal government will pay for healthcare products and services, which could result in reduced demand for Homology’s product candidates or additional pricing pressures.

Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. Legally-mandated price controls on payment amounts by third-party payors or other restrictions could harm Homology’s business, results of operations, financial condition and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce the ultimate demand for Homology’s product candidates or put pressure on its product pricing.

 

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In the EU, similar political, economic and regulatory developments may affect Homology’s ability to profitably commercialize its product candidates, if approved. In addition to continuing pressure on prices and cost containment measures, legislative developments at the EU or member state level may result in significant additional requirements or obstacles that may increase Homology’s operating costs. The delivery of healthcare in the EU, including the establishment and operation of health services and the pricing and reimbursement of medicines, is almost exclusively a matter for national, rather than EU, law and policy. National governments and health service providers have different priorities and approaches to the delivery of healthcare and the pricing and reimbursement of products in that context. In general, however, the healthcare budgetary constraints in most EU member states have resulted in restrictions on the pricing and reimbursement of medicines by relevant health service providers. Coupled with ever-increasing EU and national regulatory burdens on those wishing to develop and market products, this could prevent or delay marketing approval of Homology’s product candidates, restrict or regulate post-approval activities and affect its ability to commercialize its product candidates, if approved.

In markets outside of the United States and EU, reimbursement and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies.

On December 13, 2021, Regulation No 2021/2282 on Health Technology Assessment, or HTA amending Directive 2011/24/EU, was adopted. While the regulation entered into force in January 2022, it will only begin to apply from January 2025 onwards, with preparatory and implementation-related steps to take place in the interim. Once the regulation becomes applicable, it will have a phased implementation depending on the concerned products. The regulation intends to boost cooperation among EU member states in assessing health technologies, including new medicinal products, and providing the basis for cooperation at the EU level for joint clinical assessments in these areas. The regulation will permit EU member states to use common HTA tools, methodologies, and procedures across the EU, working together in four main areas, including joint clinical assessment of the innovative health technologies with the most potential impact for patients, joint scientific consultations whereby developers can seek advice from HTA authorities, identification of emerging health technologies to identify promising technologies early, and continuing voluntary cooperation in other areas. Individual EU member states will continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) aspects of health technology, and making decisions on pricing and reimbursement.

Homology cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action in the United States, the EU or any other jurisdiction. If Homology or any third parties it may engage are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if Homology or such third parties are not able to maintain regulatory compliance, Homology’s product candidates may lose any regulatory approval that may have been obtained and Homology may not achieve or sustain profitability.

Homology’s business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable healthcare regulatory laws, which could expose Homology to penalties.

Homology’s business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers, may expose it to broadly applicable fraud and abuse and other healthcare laws and regulations. These laws may constrain the business or financial arrangements and relationships through which Homology conducts its operations, including how it researches, markets, sells and distributes its product candidates, if approved. Such laws include:

 

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the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or providing any remuneration (including any kickback, bribe, or certain rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in

 

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part, under U.S. federal and state healthcare programs such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

 

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the U.S. federal false claims and civil monetary penalties laws, including the civil False Claims Act, which, among other things, impose criminal and civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the U.S. federal government, claims for payment or approval that are false or fraudulent, knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim, or from knowingly making a false statement to avoid, decrease or conceal an obligation to pay money to the U.S. federal government. The federal False Claims Act also permits a private individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the federal False Claims Act and to share in any monetary recovery. In addition, the government may assert that a claim including items and services resulting from a violation of the U.S. federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;

 

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The Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for, healthcare benefits, items or services; similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

 

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the FDCA, which prohibits, among other things, the adulteration or misbranding of drugs, biologics and medical devices;

 

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the U.S. Public Health Service Act, which prohibits, among other things, the introduction into interstate commerce of a biological product unless a biologics license is in effect for that product;

 

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the U.S. federal legislation commonly referred to as the Physician Payments Sunshine Act, enacted as part of the ACA, and its implementing regulations, which requires certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program to report annually to the government information related to certain payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician practitioners (physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, anesthesiologist assistants and certified nurse midwives), and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members;

 

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analogous U.S. state laws and regulations, including: state anti-kickback and false claims laws, which may apply to Homology’s business practices, including but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payor, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S. federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; and state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information, which requires tracking gifts and other remuneration and items of value provided to healthcare professionals; and

 

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similar healthcare laws and regulations in the EU and other jurisdictions, including reporting requirements detailing interactions with and payments to healthcare providers. For instance, in the EU, interactions between pharmaceutical companies and healthcare professionals and healthcare organizations are also governed by strict laws, regulations, industry self-regulation codes of conduct

 

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and physicians’ codes of professional conduct both at EU level and member states level. The provision of benefits or advantages to physicians to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order or use of pharmaceutical products is prohibited in the EU. Relationships with healthcare professionals and associations are subject to stringent anti-gift statutes and anti-bribery laws, the scope of which differs across the EU. In addition, national “Sunshine Acts” may require pharmaceutical companies to report/publish transfers of value provided to healthcare professionals and associations on a regular (e.g. annual) basis.

Ensuring that Homology’s internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that Homology’s business practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations. If Homology’s operations are found to be in violation of any of the laws described above or any other governmental laws and regulations that may apply to Homology, Homology may be subject to significant penalties, including civil, criminal and administrative penalties, damages, fines, exclusion from government-funded healthcare programs, such as Medicare and Medicaid or similar programs in other countries or jurisdictions, disgorgement, individual imprisonment, contractual damages, reputational harm, diminished profits and the curtailment or restructuring of Homology’s operations. If any of the physicians or other providers or entities with whom Homology expects to do business are found to not be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs and imprisonment, which could affect Homology’s ability to operate its business. Further, defending against any such actions can be costly, time-consuming and may require significant personnel resources. Therefore, even if Homology is successful in defending against any such actions that may be brought against it, its business may be impaired.

Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect Homology’s business, results of operations, and financial condition.

The global data protection landscape is rapidly evolving, and Homology is or may become subject to numerous state, federal and foreign laws, requirements and regulations governing the collection, use, disclosure, retention, and security of personal information, such as information that Homology may collect in connection with clinical trials. In the United States, HIPAA as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and regulations promulgated thereunder, or collectively, HIPAA, imposes, among other things, certain standards relating to the privacy, security, transmission and breach reporting of individually identifiable health information. Certain states have also adopted comparable privacy and security laws and regulations, some of which may be more stringent than HIPAA. Such laws and regulations will be subject to interpretation by various courts and other governmental authorities, thus creating potentially complex compliance issues for Homology and its future customers and strategic partners. For example, California enacted the California Consumer Privacy Act, or CCPA, which went into effect January 1, 2020. The CCPA increases data privacy obligations for covered companies and provides individual privacy rights to California consumers, including the right to opt out of certain disclosures of their information. The CCPA also creates a private right of action with statutory damages for certain data breaches, thereby potentially increasing the likelihood of and risks associated with a data breach. Although the law includes limited exceptions, including for “protected health information” maintained by a covered entity or business associate, it may regulate or impact Homology’s processing of personal information depending on the context. Further, the California Privacy Rights Act, or CPRA, generally went into effect on January 1, 2023 and significantly amends the CCPA. It imposes additional data protection obligations on covered companies doing business in California, including additional consumer rights processes and opt outs for certain uses of sensitive data. It also creates a new California data protection agency specifically tasked to enforce the law, which will likely result in increased regulatory scrutiny of California businesses in the areas of data protection and security. The substantive requirements for businesses subject to the CPRA become enforceable on July 1, 2023. Similar laws have passed in other states and are

 

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continuing to be proposed at the state and federal level, reflecting a trend toward more stringent privacy legislation in the United States. The enactment of such laws could have potentially conflicting requirements that would make compliance challenging.

Furthermore, the Federal Trade Commission, or FTC, and many state Attorneys General continue to enforce federal and state consumer protection laws against companies for online collection, use, dissemination and security practices that appear to be unfair or deceptive. For example, according to the FTC, failing to take appropriate steps to keep consumers’ personal information secure can constitute unfair acts or practices in or affecting commerce in violation of Section 5(a) of the Federal Trade Commission Act. The FTC expects a company’s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities.

Homology’s operations abroad may also be subject to increased scrutiny or attention from data protection authorities. For example, in Europe, the GDPR imposes obligations and restrictions on the collection and use of personal data relating to individuals located in the European Economic Area, or EEA. Companies that must comply with the GDPR face increased compliance obligations and risk, including more robust regulatory enforcement of data protection requirements and potential fines for noncompliance of up to €20 million or 4% of the annual global revenues of the noncompliant company, whichever is greater. Among other requirements, the GDPR regulates transfers of personal data subject to the GDPR to third countries that have not been found to provide adequate protection to such personal data, including the United States. Case law from the Court of Justice of the European Union, or CJEU, states that reliance on the standard contractual clauses – a standard form of contract approved by the European Commission as an adequate personal data transfer mechanism – alone may not necessarily be sufficient in all circumstances and that transfers must be assessed on a case-by-case basis. Following a period of legal complexity and uncertainty regarding international personal data transfers, particularly to the United States, Homology expects the regulatory guidance and enforcement landscape to continue to develop, in relation to transfers to the United States and elsewhere. As a result, Homology may have to make certain operational changes and it will have to implement revised standard contractual clauses and other relevant documentation for existing data transfers within required time frames.

Since the beginning of 2021, Homology has also been subject to the UK data protection regime, which imposes separate but similar obligations to those under the GDPR and comparable penalties, including fines of up to £17.5 million or 4% of a noncompliant company’s global annual revenue for the preceding financial year, whichever is greater. If Homology continues to expand into other foreign countries and jurisdictions, it may be subject to additional laws and regulations that may affect how it conducts business.

Although Homology works to comply with applicable laws, regulations and standards, its contractual obligations and other legal obligations, these requirements are evolving and may be modified, interpreted and applied in an inconsistent manner from one jurisdiction to another, and may conflict with one another or other legal obligations with which Homology must comply. Any failure or perceived failure by Homology or its employees, representatives, contractors, consultants, collaborators, or other third parties to comply with such requirements or adequately address privacy and security concerns, even if unfounded, could result in additional cost and liability to Homology, damage its reputation, and adversely affect its business and results of operations.

Homology is subject to environmental, health and safety laws and regulations, and Homology may become exposed to liability and substantial expenses in connection with environmental compliance or remediation activities.

Homology’s operations are subject to numerous environmental, health and safety laws and regulations. These laws and regulations govern, among other things, the controlled use, handling, release and disposal of and the maintenance of a registry for, hazardous materials and biological materials, such as chemical solvents, human

 

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cells, carcinogenic compounds, mutagenic compounds and compounds that have a toxic effect on reproduction, laboratory procedures and exposure to blood-borne pathogens. If Homology fails to comply with such laws and regulations, it could be subject to fines or other sanctions.

As with other companies engaged in activities similar to Homology’s, Homology faces a risk of environmental liability inherent in its current and historical activities, including liability relating to releases of or exposure to hazardous or biological materials. Environmental, health and safety laws and regulations are becoming more stringent. Homology may be required to incur substantial expenses in connection with future environmental compliance or remediation activities, in which case, the production efforts of Homology’s third-party manufacturers or its development efforts may be interrupted or delayed.

Homology is currently subject to securities class action litigation and may be subject to similar or other litigation in the future, which will require significant management time and attention, result in significant legal expenses and may result in unfavorable outcomes, which may have a material adverse effect on Homology’s business, operating results and financial condition, and negatively affect the price of Homology’s common stock.

Homology is, and may in the future become, subject to various legal proceedings and claims that arise in or outside the ordinary course of business. In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for Homology because biopharmaceutical companies have experienced significant stock price volatility in recent years. For example, on March 25, 2022, a stockholder of Homology, Michael C. Pizzuto, filed a putative class action complaint alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, against Homology and certain of its executives. Pizzuto v. Homology Medicines, Inc., No. 2:22– CV – 01968 (C.D. Cal 2022). The complaint alleges that Homology failed to disclose certain information regarding efficacy and safety in connection with a Phase 1/2 HMI-102 clinical trial, and seeks damages in an unspecified amount. Homology filed a motion to transfer the case to the United States District Court for the District of Massachusetts on September 2, 2022, and a motion to dismiss on October 17, 2022. On April 18, 2023, the court granted the motion to transfer, finding that venue was not proper in the Central District of California and transferring the case to the District of Massachusetts. Following the transfer, the case number changed to 1:23-cv-10858-AK (D. Mass.). On May 9, 2023, the Massachusetts court issued an order permitting the parties to submit updated briefs in connection with the motion to dismiss, which were submitted on June 8, 2023, July 13, 2023, and August 3, 2023. The motion to dismiss remains pending.

The results of the securities class action lawsuit and any future legal proceedings cannot be predicted with certainty. Also, Homology’s insurance coverage may be insufficient, its assets may be insufficient to cover any amounts that exceed its insurance coverage, and it may have to pay damage awards or otherwise may enter into settlement arrangements in connection with such claims. Any such payments or settlement arrangements in current or future litigation could have a material adverse effect on Homology’s business, operating results or financial condition. Even if the plaintiffs’ claims are not successful, current or future litigation could result in substantial costs and significantly and adversely impact Homology’s reputation and divert management’s attention and resources, which could have a material adverse effect on its business, operating results and financial condition, and negatively affect the price of its common stock. In addition, such lawsuits may make it more difficult to finance Homology’s operations.

Risks Related to Commercialization

Should Homology resume development of its product candidates, it faces significant competition in an environment of rapid technological change, and there is a possibility that Homology’s competitors may achieve regulatory approval before it or develop therapies that are safer or more advanced or effective than Homology’s, which may harm its financial condition and its ability to successfully market or commercialize any product candidates it may develop.

The development and commercialization of new genetic medicine products is highly competitive. Moreover, the gene editing field is characterized by rapidly changing technologies, significant competition, and a strong

 

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emphasis on intellectual property. Should Homology resume development of its product candidates, it will face competition with respect to any product candidates that it may seek to develop or commercialize from major pharmaceutical companies, specialty pharmaceutical companies, and biotechnology companies worldwide. Potential competitors also include academic institutions, government agencies, and other public and private research organizations that conduct research, seek patent protection, and establish collaborative arrangements for research, development, manufacturing, and commercialization.

There are a number of large pharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development of products for the treatment of the disease indications for which Homology has research programs, including PKU, MLD, Hunter syndrome, hemoglobinopathies and ophthalmological diseases. Some of these competitive products and therapies are based on scientific approaches that are similar to Homology’s approach, and others are based on entirely different approaches.

Historically, Homology’s platform and product focus has been the development of genetic medicines using its proprietary AAVHSCs in vivo through a nuclease-free gene editing modality, gene therapy, or GTx-mAb, which is designed to produce antibodies throughout the body. Should Homology resume development of such programs, and if Homology’s former programs were to be approved for the indications for which Homology had been conducting clinical trials, they may compete with other products under development, including gene editing and gene therapy products or other types of therapies, such as small molecule, antibody or protein therapies. If Homology’s PKU treatments are approved, they may compete with therapies from American Gene Technologies, BioMarin, Censa Pharmaceuticals, Generation Bio, Nestlé Health Science, Sangamo Therapeutics and Synlogic. However, Homology believes that only gene therapy or gene editing approaches have the potential to restore the normal Phe biochemical pathway with a single administration. If Homology’s Hunter syndrome treatment is approved, it may compete with therapies from Shire and/or GC Pharma. If Homology’s MLD treatment is approved, it may compete with therapies from Orchard Therapeutics, Passage Bio and/or Shire. In vivo gene therapy approaches provide potential advantages over ex vivo approaches. There are a number of companies developing nuclease-based gene editing technologies using CRISPR/Cas9, TALENs, meganucleases, Mega-TALs and ZFNs, including but not limited to Beam Therapeutics, bluebird bio, Caribou Biosciences, Cellectis, CRISPR Therapeutics, Editas Medicine, Intellia Therapeutics, Precision BioSciences, Prime Therapeutics and Sangamo Therapeutics and non-nuclease-based technology, including LogicBio Therapeutics.

Many of Homology’s current or potential competitors, either alone or with their collaboration partners, have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals, and marketing approved products than Homology does. Homology has requested withdrawal or inactivation of its previously open INDs, so Homology is currently not progressing any product candidates through the development process. Mergers and acquisitions in the pharmaceutical, biotechnology, and gene therapy industries may result in even more resources being concentrated among a smaller number of Homology’s competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with Homology in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, Homology’s programs. Homology’s commercial opportunities could be reduced or eliminated if its competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient, or are less expensive than any products that Homology may develop or that would render any products that it may develop obsolete or non-competitive. Homology’s competitors also may obtain FDA or other regulatory approval for their products more rapidly than Homology may obtain approval for its products, which could result in its competitors establishing a strong market position before Homology is able to enter the market. Additionally, technologies developed by Homology’s competitors may render its potential product candidates uneconomic or obsolete, and Homology may not be successful in marketing any product candidates it may develop against competitors.

 

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In addition, as a result of the expiration or successful challenge of Homology’s patent rights, Homology could face more litigation with respect to the validity and/or scope of patents relating to its competitors’ products. The availability of Homology’s competitors’ products could limit the demand, and the price Homology is able to charge, for any products that it may develop and commercialize.

Should Homology resume development of its product candidates, the successful commercialization of Homology’s product candidates will depend in part on the extent to which governmental authorities and health insurers establish adequate coverage, reimbursement levels and pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for Homology’s product candidates, if approved, could limit Homology’s ability to market those products and decrease its ability to generate revenue.

The availability and adequacy of coverage and reimbursement by governmental healthcare programs such as Medicare and Medicaid, private health insurers and other third-party payors are essential for most patients to be able to afford prescription medications such as Homology’s product candidates, assuming FDA or foreign authorities approval. Homology’s ability to achieve acceptable levels of coverage and reimbursement for products by governmental authorities, private health insurers and other organizations will have an effect on Homology’s ability to successfully commercialize its product candidates. Assuming Homology obtains coverage for its product candidates by a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high. Moreover, for drugs and biologics administered under the supervision of a physician, obtaining coverage and adequate reimbursement may be particularly difficult because of the higher prices often associated with such products. Homology cannot be sure that coverage and reimbursement in the United States, the EU or elsewhere will be available for its product candidates or any product that it may develop, and any reimbursement that may become available may be decreased or eliminated in the future.

Coverage and reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that use of a product is:

 

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a covered benefit under its health plan;

 

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safe, effective and medically necessary;

 

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appropriate for the specific patient;

 

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cost-effective; and

 

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neither experimental nor investigational.

Third-party payors increasingly are challenging prices charged for pharmaceutical products and services, and many third-party payors may refuse to provide coverage and reimbursement for particular drugs or biologics when an equivalent generic drug, biosimilar or a less expensive therapy is available. It is possible that a third-party payor may consider Homology’s product candidates as substitutable and only offer to reimburse patients for the less expensive product. Even if Homology shows improved efficacy or improved convenience of administration with its product candidates, pricing of existing third-party therapeutics may limit the amount Homology will be able to charge for its product candidates. These third-party payors may deny or revoke the reimbursement status of a given product or establish prices for new or existing marketed products at levels that are too low to enable Homology to realize an appropriate return on its investment in its product candidates. For products administered under the supervision of a physician, obtaining coverage and adequate reimbursement may be particularly difficult because of the higher prices often associated with such drugs. Additionally, separate reimbursement for the product itself or the treatment or procedure in which the product is used may not be available, which may impact physician utilization. If reimbursement is not available or is available only at limited levels, Homology may not be able to successfully commercialize its product candidates, and may not be able to obtain a satisfactory financial return on its product candidates.

There is significant uncertainty related to the insurance coverage and reimbursement of newly-approved products. In the United States, third-party payors, including private and governmental payors, such as the

 

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Medicare and Medicaid programs, play an important role in determining the extent to which new drugs and biologics will be covered. The Medicare and Medicaid programs increasingly are used as models in the United States for how private payors and other governmental payors develop their coverage and reimbursement policies for drugs and biologics. Some third-party payors may require pre-approval of coverage for new or innovative devices or drug therapies before they will reimburse healthcare providers who use such therapies. Homology cannot predict at this time what third-party payors will decide with respect to the coverage and reimbursement for its product candidates.

No uniform policy for coverage and reimbursement for products exists among third-party payors in the United States. Therefore, coverage and reimbursement for products can differ significantly among third-party payors. As a result, the coverage determination process is often a time-consuming and costly process that will require Homology to provide scientific and clinical support for the use of its product candidates to each third-party payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. Furthermore, rules and regulations regarding reimbursement change frequently, in some cases on short notice, and Homology believes that changes in these rules and regulations are likely.

Outside the United States, international operations are generally subject to extensive governmental price controls and other market regulations, and Homology believes the increasing emphasis on cost-containment initiatives in Europe and other countries have and will continue to put pressure on the pricing and usage of its product candidates. In many countries, the prices of medical products are subject to varying price control mechanisms as part of national health systems. Other countries allow companies to fix their own prices for medical products, but monitor and control company profits. Additional foreign price controls or other changes in pricing regulation could restrict the amount that Homology is able to charge for its product candidates. Accordingly, in markets outside the United States, the reimbursement for Homology’s product candidates may be reduced compared with the United States and may be insufficient to generate commercially-reasonable revenue and profits.

Even if a pharmaceutical product obtains a marketing authorization in the EU, there can be no assurance that reimbursement for such product will be secured on a timely basis or at all. Governments influence the price of medicinal products through their pricing and reimbursement rules and control of national healthcare systems that fund a large part of the cost of those products to consumers. Member states are free to restrict the range of pharmaceutical products for which their national health insurance systems provide reimbursement, and to control the prices and reimbursement levels of pharmaceutical products for human use. Some jurisdictions operate positive and negative list systems under which products may only be marketed once a reimbursement price has been agreed to by the government. Member states may approve a specific price or level of reimbursement for the pharmaceutical product, or alternatively adopt a system of direct or indirect controls on the profitability of the company responsible for placing the pharmaceutical product on the market, including volume-based arrangements, caps and reference pricing mechanisms. To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost-effectiveness of a particular product candidate to currently available therapies. Other member states allow companies to fix their own prices for medicines but monitor and control company profits. The downward pressure on healthcare costs in general, particularly prescription medicines, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products. In addition, in some countries, cross border imports from low-priced markets exert a commercial pressure on pricing within a country.

Moreover, increasing efforts by governmental and third-party payors in the United States and abroad to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for Homology’s product candidates. Homology expects to experience pricing pressures in connection with the sale of its product candidates due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes.

 

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Even if any of Homology’s product candidates receives marketing approval in the future, it may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success.

If any of Homology’s product candidates receives marketing approval in the future, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community. If it does not achieve an adequate level of acceptance, Homology may not generate significant product revenues or become profitable. The degree of market acceptance of Homology’s product candidates, if approved for commercial sale, will depend on a number of factors, including but not limited to:

 

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the safety, efficacy and potential advantages compared to alternative treatments;

 

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effectiveness of sales and marketing efforts;

 

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the cost of treatment in relation to alternative treatments, including any similar generic treatments;

 

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Homology’s ability to offer its products for sale at competitive prices;

 

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the convenience and ease of administration compared to alternative treatments;

 

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the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

 

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the strength of marketing and distribution support;

 

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the timing of market introduction of competitive products;

 

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the availability of third-party coverage and adequate reimbursement;

 

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product labeling or product insert requirements of the FDA, EMA or other regulatory authorities, including any limitations or warnings contained in a product’s approved labeling;

 

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the prevalence and severity of any side effects; and

 

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any restrictions on the use of Homology’s product together with other medications.

Because Homology expects sales of its product candidates, if approved, to generate substantially all of its product revenues for a substantial period, the failure of this product to find market acceptance would harm its business and could require it to seek additional financing.

Should Homology resume development of its product candidates, if Homology is unable to establish sales, marketing and distribution capabilities either on Homology’s own or in collaboration with third parties, Homology may not be successful in commercializing its product candidates, if approved. Moreover, provisions in Homology’s agreements with Pfizer may inhibit Homology’s ability to enter into future collaborations with third parties.

Homology does not have any infrastructure for the sales, marketing or distribution of its products, and the cost of establishing and maintaining such an organization may exceed the cost-effectiveness of doing so.

Should Homology resume development of its product candidates, there are significant expenses and risks involved with establishing its own sales, marketing and distribution capabilities, including Homology’s ability to hire, retain and appropriately incentivize qualified individuals, generate sufficient sales leads, provide adequate training to sales and marketing personnel, and effectively manage a geographically dispersed sales and marketing team. Any failure or delay in the development of Homology’s internal sales, marketing and distribution capabilities could delay any product launch, which would adversely impact the commercialization of Homology’s product candidates. Additionally, if the commercial launch of any of Homology’s product candidates for which it recruits a sales force and establish marketing capabilities is delayed or does not occur for any reason, Homology would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and Homology’s investment would be lost if it cannot retain or reposition its sales and marketing personnel.

 

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Homology does not anticipate having the resources in the foreseeable future to allocate to the sales and marketing of its product candidates in certain markets overseas. Therefore, Homology’s future sales in these markets will largely depend on its ability to enter into and maintain collaborative relationships for such capabilities, the collaborator’s strategic interest in the product and such collaborator’s ability to successfully market and sell the product. Homology intends to pursue collaborative arrangements regarding the sale and marketing of its product candidates, if approved, for certain markets overseas; however, Homology cannot assure that it will be able to establish or maintain such collaborative arrangements, or if able to do so, that they will have effective sales forces.

If Homology is unable to build its own sales force or negotiate a collaborative relationship for the commercialization of its product candidates, Homology may be forced to delay the potential commercialization of its product candidates or reduce the scope of its sales or marketing activities for its product candidates. If Homology elects to increase its expenditures to fund commercialization activities itself, it will need to obtain additional capital, which may not be available to it on acceptable terms, or at all. Homology could enter into arrangements with collaborative partners at an earlier stage than otherwise would be ideal and it may be required to relinquish rights to its product candidates or otherwise agree to terms unfavorable to it, any of which may have an adverse effect on its business, operating results and prospects.

If Homology is unable to establish adequate sales, marketing and distribution capabilities, either on its own or in collaboration with third parties, Homology will not be successful in commercializing its product candidates, and may not become profitable and may incur significant additional losses. Homology will be competing with many companies that currently have extensive and well-funded marketing and sales operations. Without an internal team or the support of a third party to perform marketing and sales functions, Homology may be unable to compete successfully against these more established companies.

If Homology obtains approval to commercialize any products outside of the United States, a variety of risks associated with international operations could materially adversely affect its business.

If any of Homology’s product candidates are approved for commercialization, Homology may enter into agreements with third parties to market it in certain jurisdictions outside the United States. Homology expects that it will be subject to additional risks related to international pharmaceutical operations, including:

 

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different regulatory requirements for drug and biologic approvals and rules governing drug and biologic commercialization and country-specific regulations of gene therapies in foreign countries;

 

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complex and restrictive import/export regulations;

 

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reduced protection for intellectual property rights;

 

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foreign reimbursement, pricing and insurance regimes;

 

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potential noncompliance with the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act 2010 and similar anti-bribery and anticorruption laws in other jurisdictions;

 

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production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;

 

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political and economic instability, including in light of international terrorism and conflicts;

 

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fluctuations in currency exchange rates; and

 

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higher costs of doing business internationally, including increased accounting, travel infrastructure and legal compliance costs.

Homology has no prior experience in these areas. In addition, there are complex regulatory, tax, labor and other legal requirements imposed by both the EU and many of the EU member states with which Homology will need to comply. Many U.S.-based biotechnology companies have found the process of marketing their own products in Europe to be very challenging.

 

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In the future, any product candidates for which Homology may seek approval as biologic products may face competition sooner than anticipated.

The Patient Protection and Affordable Care Act, signed into law on March 23, 2010, includes a subtitle called the Biologics Price Competition and Innovation Act of 2009, or BPCIA, which created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-licensed reference biological product. Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that the reference product was first licensed by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from the date on which the reference product was first licensed. During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing the sponsor’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of their product. The law is complex and is still being interpreted and implemented by the FDA. As a result, its ultimate impact, implementation, and meaning are subject to uncertainty.

There is a risk that any of Homology’s product candidates approved as a biological product under a BLA would not qualify for the 12-year period of exclusivity or that this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider Homology’s product candidates to be reference products for competing products, potentially creating the opportunity for generic competition sooner than anticipated. Jurisdictions in addition to the United States have established abbreviated pathways for regulatory approval of biological products that are biosimilar to earlier approved reference products. For example, the EU has had an established regulatory pathway for biosimilars since 2006. Moreover, the extent to which a biosimilar, once approved, will be substituted for any one of Homology’s reference products in a way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing.

Risks Related to Homology’s Dependence on Third Parties

Homology has historically contracted with third parties, including Oxford Biomedica Solutions LLC, for the manufacture of certain materials for its research programs, preclinical and clinical studies. This reliance on third parties increases the risk that Homology will not have sufficient quantities of such materials, product candidates, or any medicines that it may develop and commercialize, or that such supply will not be available to it at an acceptable cost or in compliance with regulatory requirements, which could delay, prevent, or impair its development or commercialization efforts if Homology were to resume such activities.

Homology has historically relied on third-party manufacturers for the manufacture of materials for research programs, preclinical and clinical studies. Homology do not have long-term supply agreements with all of the third-party manufacturers, and Homology purchases its required supply on a purchase order basis. Furthermore, the raw materials for Homology’s product candidates are sourced, in some cases, from a single-source supplier. Should Homology resume development of its product candidates, if it were to experience an unexpected loss of supply of any of its product candidates or any of its future product candidates for any reason, whether as a result of manufacturing, supply or storage issues or otherwise, Homology could experience delays, disruptions, suspensions or terminations of, or be required to restart or repeat, any pending or ongoing clinical trials.

Homology may be unable to establish any agreements with third-party manufacturers or to do so on acceptable terms. Even if Homology is able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

 

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the possible breach of the manufacturing agreement by the third party;

 

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the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for Homology;

 

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  •  

reliance on the third party for regulatory compliance, quality assurance, safety, and pharmacovigilance and related reporting;

 

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inability to meet Homology’s drug specifications and quality requirements consistently;

 

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delay or inability to procure sufficient manufacturing capacity;

 

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issues related to scale-up of manufacturing;

 

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costs and validation of new equipment and facilities required for scale-up;

 

  •  

reliance on single sources for drug components;

 

  •  

lack of qualified backup suppliers for those components that are currently purchased from a sole or single-source supplier;

 

  •  

misappropriation of proprietary information, including Homology’s trade secrets and know-how;

 

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the mislabeling of clinical supplies, potentially resulting in the wrong dose amounts being supplied or study drug or placebo not being properly identified;

 

  •  

clinical supplies not being delivered to clinical sites on time, leading to clinical trial interruptions, or of drug supplies not being distributed to commercial vendors in a timely manner, resulting in lost sales;

 

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operations of Homology’s third-party manufacturers or suppliers could be disrupted by conditions unrelated to its business or operations, including the bankruptcy of the manufacturer or supplier; and

 

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carrier disruptions or increased costs that are beyond Homology’s control.

Homology does not have complete control over all aspects of the manufacturing process of, and is dependent on, its contract manufacturing partners for compliance with GMP regulations for manufacturing both active drug substances and finished drug products. Third-party manufacturers may not be able to comply with GMP regulations or similar regulatory requirements outside the United States. The failure of Homology’s third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on Homology, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocations, seizures or recalls of product candidates or medicines, operating restrictions, and criminal prosecutions, any of which could significantly and adversely affect supplies of Homology’s medicines and harm its business, financial condition, results of operations, and prospects.

Assuming Homology were to resume the development of product candidates, any medicines that Homology may develop may compete with other product candidates and products for access to manufacturing facilities. There are a limited number of manufacturers that operate under GMP regulations and that might be capable of manufacturing for Homology. Any performance failure on the part of Homology’s existing or future manufacturers could delay clinical development or marketing approval.

Homology’s current and anticipated future dependence upon others for the manufacture of any product candidates it may develop or medicines may adversely affect its future profit margins and its ability to commercialize any medicines that receive marketing approval on a timely and competitive basis.

Should Homology resume development of its product candidates, it would rely on third parties to conduct, supervise and monitor its clinical trials. If those third parties did not successfully carry out their contractual duties, or if they performed in an unsatisfactory manner, it may harm Homology’s business.

Should Homology resume development of its product candidates, it would rely on CROs and clinical trial sites to ensure the proper and timely conduct of its clinical trials, and expects to have limited influence over their actual performance.

 

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Homology would rely upon CROs to monitor and manage data for its clinical programs, as well as the execution of future nonclinical studies. Homology’s reliance on CROs for clinical development activities limits its control over these activities, but it would remain responsible for ensuring that each of its studies is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards and its reliance on the CROs would not relieve it of its regulatory responsibilities.

Homology and its CROs will be required to comply with GLP and GCP, which are regulations and guidelines enforced by the FDA and are also required by the competent authorities in the EU and comparable foreign regulatory authorities in the form of International Conference on Harmonization guidelines for any of Homology’s product candidates that are in preclinical and clinical development. The Regulatory authorities enforce GCP through periodic inspections of trial sponsors, principal investigators and clinical trial sites. If Homology or its CROs fail to comply with GCP, the clinical data generated in Homology’s clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require Homology to perform additional clinical trials before approving Homology’s marketing applications. Homology cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of its clinical trials comply with GCP requirements. In addition, Homology’s clinical trials must be conducted with product produced under GMP regulations. Accordingly, if Homology’s CROs fail to comply with these regulations or fail to recruit a sufficient number of subjects, Homology may be required to repeat clinical trials, which would delay the regulatory approval process.

Homology’s CROs will not be its employees, and Homology will not control whether or not they devote sufficient time and resources to Homology’s future clinical and nonclinical programs. These CROs may also have relationships with other commercial entities, including Homology’s competitors, for whom they may also be conducting clinical trials, or other product development activities which could harm Homology’s competitive position. Homology faces the risk of potential unauthorized disclosure or misappropriation of its intellectual property by CROs, which may reduce its trade secret protection and allow its potential competitors to access and exploit its proprietary technology. If Homology’s CROs do not successfully carry out their contractual duties or obligations or fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to Homology’s clinical protocols or regulatory requirements or for any other reasons, Homology’s clinical trials may be extended, delayed or terminated, and it may not be able to obtain regulatory approval for, or successfully commercialize any product candidate that it develops. As a result, Homology’s financial results and the commercial prospects for any product candidate that it develops would be harmed, its costs could increase, and its ability to generate revenues could be delayed.

If Homology’s relationship with any CROs terminate, Homology may not be able to enter into arrangements with alternative CROs or do so on commercially reasonable terms. Switching or adding additional CROs involves substantial cost and requires management time and focus. In addition, there is a natural transition period when a new CRO commences work. As a result, delays occur, which can materially impact Homology’s ability to meet its desired clinical development timelines. Though Homology intends to carefully manage its relationships with its CROs, there can be no assurance that it will not encounter challenges or delays in the future or that these delays or challenges will not have an adverse impact on Homology’s business, financial condition and prospects.

Should Homology resume development of its product candidates, Homology may collaborate with third parties for the development and commercialization of its product candidates in the future, but there are no assurances that Homology will succeed in establishing and maintaining such collaborative relationships, which may significantly limit its ability to develop and commercialize its product candidates successfully, if at all.

Should Homology resume development of its product candidates, Homology may seek collaborative relationships for the development and commercialization of its product candidates in the future should it resume such activities. Failure to obtain a collaborative relationship for any of Homology’s product candidates may significantly impair the potential for the product candidate. Homology would also need to enter into collaborative

 

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relationships to provide funding to support its other research and development programs. The process of establishing and maintaining collaborative relationships is difficult, time-consuming and involves significant uncertainty, such as:

 

  •  

a collaboration partner may shift its priorities and resources away from Homology’s product candidates due to a change in business strategies, or a merger, acquisition, sale or downsizing;

 

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a collaboration partner may seek to renegotiate or terminate their relationships with Homology due to unsatisfactory clinical results, manufacturing issues, a change in business strategy, a change of control or other reasons;

 

  •  

a collaboration partner may cease development in therapeutic areas which are the subject of Homology’s strategic collaboration;

 

  •  

a collaboration partner may not devote sufficient capital or resources towards Homology’s product candidates;

 

  •  

a collaboration partner may change the success criteria for a product candidate thereby delaying or ceasing development of such candidate;

 

  •  

a significant delay in initiation of certain development activities by a collaboration partner will also delay payment of milestones tied to such activities, thereby impacting Homology’s ability to fund its own activities;

 

  •  

a collaboration partner could develop a product that competes, either directly or indirectly, with Homology’s product candidate;

 

  •  

a collaboration partner with commercialization obligations may not commit sufficient financial or human resources to the marketing, distribution or sale of a product;

 

  •  

a collaboration partner with manufacturing responsibilities may encounter regulatory, resource or quality issues and be unable to meet demand requirements;

 

  •  

a collaboration partner may terminate a strategic alliance;

 

  •  

a dispute may arise between Homology and a partner concerning the research, development or commercialization of a product candidate resulting in a delay in milestones, royalty payments or termination of an alliance and possibly resulting in costly litigation or arbitration which may divert management attention and resources; and

 

  •  

a partner may use Homology’s products or technology in such a way as to invite litigation from a third party.

If any collaborator fails to fulfill its responsibilities in a timely manner, or at all, Homology’s research, clinical development, manufacturing or commercialization efforts related to that collaboration could be delayed or terminated, or it may be necessary for Homology to assume responsibility for expenses or activities that would otherwise have been the responsibility of Homology’s collaborator. If Homology is unable to establish and maintain collaborative relationships on acceptable terms or to successfully transition terminated collaborative agreements, it may have to delay or discontinue further development of one or more of its product candidates, undertake development and commercialization activities at its own expense or find alternative sources of capital. Moreover, any collaborative partners Homology enters into agreements with in the future may shift their priorities and resources away from Homology’s product candidates or seek to renegotiate or terminate their relationships with Homology.

 

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If Homology fails to comply with its obligations in the agreements under which it in-licenses or acquires development or commercialization rights to products, technology or data from third parties, Homology could lose such rights that are important to its business.

Homology is a party to agreements with COH for certain AAV vector-related patents and know-how, and Homology may enter into additional agreements, including license agreements, with other parties in the future that impose diligence, development and commercialization timelines, milestone payments, royalties, insurance and other obligations on Homology.

If Homology fails to comply with its obligations under the COH license, or any of Homology’s other collaborators, Homology’s counterparties may have the right to terminate these agreements, in which event Homology might not be able to develop, manufacture or market any product candidate that is covered by these agreements, which could materially adversely affect the value of the product candidate being developed under any such agreement. Termination of these agreements or reduction or elimination of Homology’s rights under these agreements may result in Homology having to negotiate new or reinstated agreements with less favorable terms, or cause Homology to lose its rights under these agreements, including its rights to important intellectual property or technology.

Risks Related to Homology’s Intellectual Property

If Homology is unable to obtain and maintain patent protection for its technology and products or if the scope of the patent protection obtained is not sufficiently broad, Homology may not be able to compete effectively in its markets.

Homology relies upon a combination of patents, trade secret protection and confidentiality agreements to protect the intellectual property related to its proprietary technologies, product candidate development programs and product candidates. Homology’s success depends in large part on its ability to secure and maintain patent protection in the United States and other countries with respect to all current and future product candidates. Homology seeks to protect its proprietary position by filing or collaborating with its licensors to file patent applications in the United States and abroad related to its proprietary technologies, development programs and product candidates. The patent prosecution process is expensive and time-consuming, and Homology may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner.

It is also possible that Homology will fail to identify patentable aspects of its research and development output before it is too late to obtain patent protection. The patent applications that Homology owns or in-licenses may fail to result in issued patents with claims that cover Homology’s proprietary products and technology, including its product candidates in the United States or in other foreign countries, in whole or in part. Alternately, Homology’s existing patents and any future patents Homology obtains may not be sufficiently broad to prevent others from using its technology or from developing competing products and technologies. There is no assurance that all potentially relevant prior art relating to Homology’s patents and patent applications has been found, which can prevent a patent from issuing from a pending patent application or later invalidate or narrow the scope of an issued patent. Even if patents do successfully issue and even if such patents cover Homology’s former product candidates or any future product candidate, third parties may challenge their validity, enforceability or scope thereof, which may result in such patents being narrowed, invalidated, or held unenforceable. Any successful challenge to these patents or any other patents owned by or licensed to Homology could deprive Homology of rights necessary for the successful commercialization of any product candidates or companion diagnostic that it may develop. Further, if Homology encounters delays in regulatory approvals, the period of time during which it could market a product candidate and companion diagnostic under patent protection could be reduced.

If the patent applications Homology holds or has in-licensed with respect to its development programs and product candidates fail to issue, if their validity, breadth or strength of protection is threatened, or if they fail to provide meaningful exclusivity for Homology’s former product candidates or any future product candidate, it could dissuade companies from collaborating with Homology to develop product candidates, encourage

 

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competitors to develop competing products or technologies and threaten Homology’s ability to commercialize future product candidates. Any such outcome could have a materially adverse effect on Homology’s business.

The patent position of biotechnology and pharmaceutical companies is highly uncertain, involves complex legal and factual questions, and is characterized by the existence of large numbers of patents and frequent litigation based on allegations of patent or other intellectual property infringement or violation. In addition, the laws of jurisdictions outside the United States may not protect Homology’s rights to the same extent as the laws of the United States. For example, European patent law restricts the patentability of methods of treatment of the human body more than United States law does. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of Homology’s patents or narrow the scope of its patent protection. Since patent applications in the United States and other jurisdictions are confidential for a period of time after filing, Homology cannot be certain that it was the first to file for patents covering its inventions. As a result, the issuance, scope, validity, enforceability and commercial value of Homology’s patent rights are highly uncertain. Homology’s pending and future patent applications may not result in the issuance of patents, or may result in the issuance of patents which fail to protect Homology’s technology or products, in whole or in part, or which fail to effectively prevent others from commercializing competitive technologies and products.

The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and Homology’s owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit Homology’s ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of Homology’s technology and products. Thus, even if Homology’s patent applications issue as patents, they may not issue in a form that will provide Homology with meaningful protection, prevent competitors from competing with Homology or otherwise provide Homology with any competitive advantage. Moreover, patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after it is filed. Various extensions may be available; however, the life of a patent, and the protection it affords, is limited. Without patent protection for Homology’s current or future product candidates, Homology may be open to competition from generic versions of such products. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, Homology’s owned and licensed patent portfolio may not provide Homology with sufficient rights to exclude others from commercializing products similar or identical to Homology’s.

Third parties may assert claims against Homology alleging infringement of their patents and proprietary rights, or Homology may need to become involved in lawsuits to defend or enforce its patents, either of which could result in substantial costs or loss of productivity, delay or prevent the development and commercialization of its product candidates, prohibit its use of proprietary technology or sale of products or put its patents and other proprietary rights at risk.

Homology’s commercial success depends, in part, upon its ability to develop, manufacture, market and sell its product candidates without alleged or actual infringement, misappropriation or other violation of the patents and proprietary rights of third parties. Litigation relating to infringement or misappropriation of patent and other intellectual property rights in the pharmaceutical and biotechnology industries is common, including patent infringement lawsuits, interferences, oppositions and reexamination proceedings before the U.S. Patent and Trademark Office, or USPTO, and corresponding foreign patent offices. The various markets in which Homology plans to operate are subject to frequent and extensive litigation regarding patents and other intellectual property rights. In addition, many companies in intellectual property-dependent industries, including the biotechnology and pharmaceutical industries, have employed intellectual property litigation as a means to gain an advantage over their competitors. Numerous United States, EU and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which Homology is developing product

 

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candidates, and as the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that Homology’s product candidates may be subject to claims of infringement of the intellectual property rights of third parties. Some claimants may have substantially greater resources than Homology does and may be able to sustain the costs of complex intellectual property litigation to a greater degree and for longer periods of time than Homology could. In addition, patent holding companies that focus solely on extracting royalties and settlements by enforcing patent rights may target Homology.

Homology may be subject to third-party claims including infringement, interference or derivation proceedings, post-grant review and inter partes review before the USPTO or similar adversarial proceedings or litigation in other jurisdictions. Even if such claims are without merit, a court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, and the holders of any such patents may be able to block Homology’s ability to commercialize the applicable product candidate unless Homology obtained a license under the applicable patents, or until such patents expire or are finally determined to be invalid or unenforceable. Similarly, if any third-party patents were held by a court of competent jurisdiction to cover aspects of Homology’s compositions, formulations, or methods of treatment, prevention or use, the holders of any such patents may be able to prohibit Homology’s use of those compositions, formulations, methods of treatment, prevention or use or other technologies, effectively blocking its ability to develop and commercialize the applicable product candidate until such patent expires or is finally determined to be invalid or unenforceable or unless Homology obtained a license.

In addition, defending such claims would cause Homology to incur substantial expenses and, if successful, could cause Homology to pay substantial damages if Homology is found to be infringing a third party’s patent rights. These damages potentially include increased damages and attorneys’ fees if Homology is found to have infringed such rights willfully. Further, if a patent infringement suit is brought against Homology or its third-party service providers, its development, manufacturing or sales activities relating to the product or product candidate that is the subject of the suit may be delayed or terminated. As a result of patent infringement claims, or in order to avoid potential infringement claims, Homology may choose to seek, or be required to seek, a license from the third party, which may require payment of substantial royalties or fees, or require Homology to grant a cross-license under its intellectual property rights. These licenses may not be available on reasonable terms or at all. Even if a license can be obtained on reasonable terms, the rights may be nonexclusive, which would give Homology’s competitors access to the same intellectual property rights. If Homology is unable to enter into a license on acceptable terms, it could be prevented from commercializing one or more of its product candidates, or forced to modify such product candidates, or to cease some aspect of its business operations, which could harm Homology’s business significantly. Homology might also be forced to redesign or modify its product candidates so that it no longer infringes the third-party intellectual property rights, which may result in significant cost or delay to Homology, or which redesign or modification could be impossible or technically infeasible. Even if Homology were ultimately to prevail, any of these events could require it to divert substantial financial and management resources that it would otherwise be able to devote to its business. In addition, if the breadth or strength of protection provided the patents and patent applications Homology owns or in-licenses is threatened, it could dissuade companies from collaborating with Homology to license, develop or commercialize current or future product candidates.

If Homology or one of its licensors were to initiate legal proceedings against a third party to enforce a patent covering one of Homology’s product candidates, the defendant could counterclaim that Homology’s patent is invalid or unenforceable. In patent litigation in the United States and in Europe, defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, for example, lack of novelty, obviousness or non-enablement. Third parties might allege unenforceability of Homology’s patents because during prosecution of the patent an individual connected with such prosecution withheld relevant information, or made a misleading statement. The outcome of proceedings involving assertions of invalidity and unenforceability during patent litigation is unpredictable. With respect to the validity of patents, for example, Homology cannot be certain that there is no invalidating prior art of which Homology and the patent examiner were unaware during prosecution, but that an

 

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adverse third party may identify and submit in support of such assertions of invalidity. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, Homology would lose at least part, and perhaps all, of the patent protection on its product candidates. Homology’s patents and other intellectual property rights also will not protect its technology if competitors design around Homology’s protected technology without infringing its patents or other intellectual property rights.

Even if resolved in Homology’s favor, litigation or other legal proceedings relating to intellectual property claims may cause Homology to incur significant expenses and could distract its technical and management personnel from their normal responsibilities. In addition, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of Homology’s confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments, and if securities analysts or investors view these announcements in a negative light, the price of Homology’s common stock could be adversely affected. Such litigation or proceedings could substantially increase Homology’s operating losses and reduce Homology’s resources available for development activities. Homology may not have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some of Homology’s competitors may be able to sustain the costs of such litigation or proceedings more effectively than Homology can because of their substantially greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have an adverse effect on Homology’s ability to compete in the marketplace.

Homology may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent which might adversely affect Homology’s ability to develop, manufacture and market its product candidates.

Homology cannot guarantee that any of its or its licensors’ patent searches or analyses, including but not limited to the identification of relevant patents, analysis of the scope of relevant patent claims or determination of the expiration of relevant patents, are complete or thorough, nor can Homology be certain that it has identified each and every third-party patent and pending application in the United States, Europe and elsewhere that is relevant to or necessary for the commercialization of its product candidates in any jurisdiction. For example, in the United States, applications filed before November 29, 2000 and certain applications filed after that date that will not be filed outside the United States remain confidential until patents issue. Patent applications in the United States, EU and elsewhere are published approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority date. Therefore, patent applications covering Homology’s product candidates could be filed by others without Homology’s knowledge. Additionally, pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover Homology’s product candidates or the use of Homology’s product candidates. After issuance, the scope of patent claims remains subject to construction as determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history. Homology’s interpretation of the relevance or the scope of a patent or a pending application may be incorrect, which may negatively impact Homology’s ability to market its product candidates. Homology may incorrectly determine that its product candidates are not covered by a third-party patent or may incorrectly predict whether a third party’s pending application will issue with claims of relevant scope. Homology’s determination of the expiration date of any patent in the United States, the EU or elsewhere that Homology considers relevant may be incorrect, which may negatively impact its ability to develop and market its product candidates. Homology’s failure to identify and correctly interpret relevant patents may negatively impact its ability to develop and market its product candidates.

If Homology fails to correctly identify or interpret relevant patents, Homology may be subject to infringement claims. Homology cannot guarantee that it will be able to successfully settle or otherwise resolve such infringement claims. If Homology fails in any such dispute, in addition to being forced to pay monetary damages, Homology may be temporarily or permanently prohibited from commercializing its product candidates.

 

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Homology might, if possible, also be forced to redesign its product candidates in a manner that no longer infringes third-party intellectual property rights. Any of these events, even if Homology were ultimately to prevail, could require it to divert substantial financial and management resources that it would otherwise be able to devote to its business.

Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing Homology’s ability to protect its product candidates.

As is the case with other biotechnology companies, Homology’s success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biotechnology and genetic medicines industries involve both technological complexity and legal complexity. Therefore, obtaining and enforcing biotechnology and genetic medicines patents is costly, time-consuming and inherently uncertain. In addition, the America Invents Act, or the AIA, which was passed in September 2011, resulted in significant changes to the U.S. patent system.

An important change introduced by the AIA is that, as of March 16, 2013, the United States transitioned from a “first-to-invent” to a “first-to-file” system for deciding which party should be granted a patent when two or more patent applications are filed by different parties claiming the same invention. Under a “first-to-file” system, assuming the other requirements for patentability are met, the first inventor to file a patent application generally will be entitled to a patent on the invention regardless of whether another inventor had made the invention earlier. A third party that files a patent application in the USPTO after that date but before Homology could therefore be awarded a patent covering an invention of Homology’s even if Homology made the invention before it was made by the third party. This will require Homology to be cognizant going forward of the time from invention to filing of a patent application and diligent in filing patent applications, but circumstances could prevent Homology from promptly filing patent applications on Homology’s inventions.

Among some of the other changes introduced by the AIA are changes that limit where a patentee may file a patent infringement suit and providing opportunities for third parties to challenge any issued patent in the USPTO. This applies to all of Homology’s U.S. patents, even those issued before March 16, 2013. Because of a lower evidentiary standard in USPTO proceedings as compared to the evidentiary standard in U.S. federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action.

Accordingly, a third party may attempt to use the USPTO procedures to invalidate Homology’s patent claims that would not have been invalidated if first challenged by the third party as a defendant in a district court action. It is not clear what, if any, impact the AIA will have on the operation of Homology’s business. However, the AIA and its implementation could increase the uncertainties and costs surrounding the prosecution of Homology’s or its licensors’ patent applications and the enforcement or defense of Homology’s or its licensors’ issued patents.

Homology may become involved in opposition, interference, derivation, inter partes review or other proceedings challenging Homology’s or its licensors’ patent rights, and the outcome of any proceedings are highly uncertain. An adverse determination in any such proceeding could reduce the scope of, or invalidate, Homology’s owned or in-licensed patent rights, allow third parties to commercialize Homology’s technology or products and compete directly with Homology, without payment to Homology, or result in Homology’s inability to manufacture or commercialize products without infringing third-party patent rights.

Additionally, the U.S. Supreme Court has ruled on several patent cases in recent years either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations, and there are other open questions under patent law that courts have yet to decisively address. In addition to increasing uncertainty with regard to Homology’s ability to obtain patents in the future, this

 

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combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways and could weaken Homology’s ability to obtain new patents or to enforce its existing patents and patents that it might obtain in the future. In addition, the European patent system is relatively stringent in the type of amendments that are allowed during prosecution, but, the complexity and uncertainty of European patent laws has also increased in recent years. Complying with these laws and regulations could limit Homology’s ability to obtain new patents in the future that may be important for its business.

Obtaining and maintaining Homology’s patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and Homology’s patent protection could be reduced or eliminated for non-compliance with these requirements.

The USPTO and European and other patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. In addition, periodic maintenance and annuity fees on any issued patent are due to be paid to the USPTO and European and other patent agencies over the lifetime of a patent. While an inadvertent failure to make payment of such fees or to comply with such provisions can in many cases be cured by additional payment of a late fee or by other means in accordance with the applicable rules, there are situations in which non-compliance with such provisions will result in the abandonment or lapse of the patent or patent application, and the partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of a patent or patent application include failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents within prescribed time limits. If Homology or its licensors fail to maintain the patents and patent applications covering Homology’s product candidates or if Homology or its licensors otherwise allow Homology’s patents or patent applications to be abandoned or lapse, it can create opportunities for competitors to enter the market, which would hurt Homology’s competitive position and could impair its ability to successfully commercialize its product candidates in any indication for which they are approved.

Homology enjoys only limited geographical protection with respect to certain patents and Homology may not be able to protect its intellectual property rights throughout the world.

Filing, prosecuting and defending patents covering Homology’s product candidates in all countries throughout the world would be prohibitively expensive, and Homology’s intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In-licensing patents covering Homology’s product candidates in all countries throughout the world may similarly be prohibitively expensive, if such opportunities are available at all. And in-licensing or filing, prosecuting and defending patents even in only those jurisdictions in which Homology develops or commercializes its product candidates may be prohibitively expensive or impractical. Competitors may use Homology’s and its licensors’ technologies in jurisdictions where Homology has not obtained patent protection or licensed patents to develop their own products and, further, may export otherwise infringing products to territories where Homology and its licensors have patent protection, but enforcement is not as strong as that in the United States or the EU. These products may compete with Homology’s product candidates, and Homology’s or its licensors’ patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

In addition, Homology intends to abandon certain national and regional patent applications while they are still pending. The grant proceeding of each national or regional patent is an independent proceeding which may lead to situations in which applications may be rejected by the relevant patent office, while substantively similar applications are granted by others. For example, relative to other countries, China has a heightened requirement for patentability and specifically requires a detailed description of medical uses of a claimed drug. Furthermore, generic drug manufacturers or other competitors may challenge the scope, validity or enforceability of Homology’s or its licensors’ patents, requiring Homology or its licensors to engage in complex, lengthy and

 

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costly litigation or other proceedings. Generic drug manufacturers may develop, seek approval for and launch generic versions of Homology’s products. It is also quite common that depending on the country, the scope of patent protection may vary for the same product candidate or technology.

The laws of some jurisdictions do not protect intellectual property rights to the same extent as the laws or regulations in the United States and the EU, and many companies have encountered significant difficulties in protecting and defending proprietary rights in such jurisdictions. Moreover, the legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets or other forms of intellectual property, which could make it difficult for Homology to prevent competitors in some jurisdictions from marketing competing products in violation of its proprietary rights generally. Proceedings to enforce Homology’s patent rights in foreign jurisdictions, whether or not successful, are likely to result in substantial costs and divert Homology’s efforts and attention from other aspects of its business, and additionally could put at risk Homology’s or its licensors’ patents of being invalidated or interpreted narrowly, could increase the risk of Homology’s or its licensors’ patent applications not issuing, or could provoke third parties to assert claims against Homology. Homology may not prevail in any lawsuits that it initiates, while damages or other remedies may be awarded to the adverse party, which may be commercially significant. If Homology prevails, damages or other remedies awarded to Homology, if any, may not be commercially meaningful. Accordingly, Homology’s efforts to enforce its intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that Homology develops or licenses. Furthermore, while Homology intends to protect its intellectual property rights in its expected significant markets, Homology cannot ensure that it will be able to initiate or maintain similar efforts in all jurisdictions in which it may wish to market its product candidates. Accordingly, Homology’s efforts to protect its intellectual property rights in such countries may be inadequate, which may have an adverse effect on Homology’s ability to successfully commercialize its product candidates in all of its expected significant foreign markets. If Homology or its licensors encounter difficulties in protecting, or are otherwise precluded from effectively protecting, the intellectual property rights important for Homology’s business in such jurisdictions, the value of these rights may be diminished and Homology may face additional competition in those jurisdictions.

In some jurisdictions, compulsory licensing laws compel patent owners to grant licenses to third parties. In addition, some countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. If Homology or any of its licensors are forced to grant a license to third parties under patents relevant to Homology’s business, or if Homology or its licensors are prevented from enforcing patent rights against third parties, Homology’s competitive position may be substantially impaired in such jurisdictions.

If Homology does not obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the term of marketing exclusivity for its product candidates, its business may be materially harmed.

The term of any individual patent depends on applicable law in the country where the patent is granted. In the United States, provided all maintenance fees are timely paid, a patent generally has a term of 20 years from its application filing date or earliest claimed non-provisional filing date. Extensions may be available under certain circumstances, but the life of a patent and, correspondingly, the protection it affords is limited. Even if Homology or its licensors obtain patents covering Homology’s product candidates, when the terms of all patents covering a product expire, Homology’s business may become subject to competition from competitive medications, including generic medications. Given the amount of time required for the development, testing and regulatory review and approval of new product candidates, patents protecting such candidates may expire before or shortly after such candidates are commercialized. As a result, Homology’s owned and licensed patent portfolio may not provide Homology with sufficient rights to exclude others from commercializing products similar or identical to Homology’s.

In the United States, a patent that covers an FDA-approved drug or biologic may be eligible for a term extension designed to restore the period of the patent term that is lost during the premarket regulatory review

 

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process conducted by the FDA. Depending upon the timing, duration and conditions of FDA marketing approval of Homology’s product candidates, one or more of Homology’s U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Act, which permits a patent term extension of up to five years for a patent covering an approved product as compensation for effective patent term lost during product development and the FDA regulatory review process. In the EU, Homology’s product candidates may be eligible for term extensions based on similar legislation. In either jurisdiction, however, Homology may not receive an extension if it fails to apply within applicable deadlines, fails to apply prior to expiration of relevant patents or otherwise fails to satisfy applicable requirements. Even if Homology is granted such extension, the duration of such extension may be less than Homology’s request. If Homology is unable to obtain a patent term extension, or if the term of any such extension is less than Homology’s request, the period during which Homology can enforce its patent rights for that product will be in effect shortened and its competitors may obtain approval to market competing products sooner. The resulting reduction of years of revenue from applicable products could be substantial.

Homology’s proprietary rights may not adequately protect its technologies and product candidates, and do not necessarily address all potential threats to its competitive advantage.

The degree of future protection afforded by Homology’s intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect Homology’s business, or permit Homology to maintain its competitive advantage. The following examples are illustrative:

 

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others may be able to make products that are the same as or similar to Homology’s product candidates but that are not covered by the claims of the patents that Homology owns or has exclusively licensed;

 

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others, including inventors or developers of Homology’s owned or in-licensed patented technologies who may become involved with competitors, may independently develop similar technologies that function as alternatives or replacements for any of Homology’s technologies without infringing Homology’s intellectual property rights;

 

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Homology or its licensors or Homology’s other collaboration partners might not have been the first to conceive and reduce to practice the inventions covered by the patents or patent applications that Homology owns, licenses or will own or license;

 

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Homology or its licensors or Homology’s other collaboration partners might not have been the first to file patent applications covering certain of the patents or patent applications that Homology or they own or have obtained a license, or will own or will have obtained a license;

 

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Homology or its licensors may fail to meet obligations to the U.S. government with respect to in-licensed patents and patent applications funded by U.S. government grants, leading to the loss of patent rights;

 

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it is possible that Homology’s pending patent applications will not result in issued patents;

 

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it is possible that there are prior public disclosures that could invalidate Homology’s or its licensors’ patents;

 

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issued patents that Homology owns or exclusively licenses may not provide Homology with any competitive advantage, or may be held invalid or unenforceable, as a result of legal challenges by its competitors;

 

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Homology’s competitors might conduct research and development activities in countries where Homology does not have patent rights, or in countries where research and development safe harbor laws exist, and then use the information learned from such activities to develop competitive products for sale in Homology’s major commercial markets;

 

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ownership, validity or enforceability of Homology’s or its licensors’ patents or patent applications may be challenged by third parties; and

 

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the patents of third parties or pending or future applications of third parties, if issued, may have an adverse effect on Homology’s business.

Homology depends on proprietary technology licensed from others. If Homology loses its existing licenses or is unable to acquire or license additional proprietary rights from third parties, Homology may not be able to continue developing its products.

Homology currently in-licenses certain intellectual property from COH. In the future Homology may in-license intellectual property from other licensors. Homology relies on certain of these licensors to file and prosecute patent applications and maintain patents and otherwise protect the intellectual property Homology licenses from them. Homology has limited control over these activities or any other intellectual property that may be related to Homology’s in-licensed intellectual property. For example, Homology cannot be certain that such activities by these licensors have been or will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents and other intellectual property rights. Homology has limited control over the manner in which its licensors initiate an infringement proceeding against a third-party infringer of the intellectual property rights, or defend certain of the intellectual property that is licensed to Homology. It is possible that the licensors’ infringement proceeding or defense activities may be less vigorous than had Homology conducted them itself. The licensing and acquisition of third-party intellectual property rights is a competitive practice, and companies that may be more established, or have greater resources than Homology does, may also be pursuing strategies to license or acquire third-party intellectual property rights that Homology may consider necessary or attractive in order to commercialize its product candidates. More established companies may have a competitive advantage over Homology due to their larger size and cash resources or greater clinical development and commercialization capabilities. There can be no assurance that Homology will be able to successfully complete such negotiations and ultimately acquire the rights to the intellectual property surrounding the additional product candidates that Homology may seek to acquire.

If Homology fails to comply with its obligations under its patent licenses with third parties, Homology could lose license rights that are important to its business.

Homology is a party to license agreements with COH, pursuant to which Homology in-licenses patents and technology for its product candidates. This existing license imposes various diligence, milestone payment, royalty, insurance and other obligations on Homology. If Homology fails to comply with these obligations or otherwise materially breaches a license agreement, Homology’s licensors may have the right to terminate the license, in which event Homology would not be able to develop or market the products covered by such licensed intellectual property. In addition, any claims asserted against Homology by its licensors may be costly and time-consuming, divert the attention of key personnel from business operations or otherwise have a material adverse effect on its business.

Homology’s reliance on third parties may require it to share its trade secrets, which increases the possibility that Homology’s trade secrets will be misappropriated or disclosed, and confidentiality agreements with employees and third parties may not adequately prevent disclosure of trade secrets and protect other proprietary information.

Homology considers proprietary trade secrets, confidential know-how and unpatented know-how to be important to its business. Homology may rely on trade secrets and confidential know-how to protect its technology, especially where patent protection is believed by Homology to be of limited value. However, trade secrets and confidential know-how are difficult to protect, and Homology has limited control over the protection of trade secrets and confidential know-how used by its licensors, collaborators and suppliers. Because Homology expects to rely on third parties to manufacture its current and future product candidates, and Homology expects to collaborate with third parties on the development of its current and future product candidates, Homology may, at times, share trade secrets with them. Homology also conducts joint research and development programs that

 

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may require it to share trade secrets under the terms of its research and development collaborations or similar agreements. Under such circumstances, trade secrets and confidential know-how can be difficult to maintain as confidential.

To protect this type of information against disclosure or appropriation by competitors, Homology’s policy is to require its employees, consultants, contractors and advisors to enter into confidentiality agreements and, if applicable, material transfer agreements, consulting agreements or other similar agreements with Homology prior to beginning research or disclosing proprietary information. These agreements typically limit the rights of the third parties to use or disclose Homology’s confidential information, including its trade secrets. However, current or former employees, consultants, contractors and advisers may unintentionally or willfully disclose Homology’s confidential information to competitors, and confidentiality agreements may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. The need to share trade secrets and other confidential information increases the risk that such trade secrets become known by Homology’s competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements. Given that Homology’s competitive position is based, in part, on its know-how and trade secrets, a competitor’s discovery of Homology’s trade secrets or other unauthorized use or disclosure would impair Homology’s competitive position and may have an adverse effect on Homology’s business and results of operations. Enforcing a claim that a third party obtained illegally and is using trade secrets and/or confidential know-how is expensive, time consuming and unpredictable, and the enforceability of confidentiality agreements may vary from jurisdiction to jurisdiction.

In addition, these agreements typically restrict the ability of Homology’s advisors, employees, third-party contractors and consultants to publish data potentially relating to Homology’s trade secrets, although Homology’s agreements may contain certain limited publication rights. Despite Homology’s efforts to protect its trade secrets, Homology’s competitors may discover its trade secrets, either through breach of Homology’s agreements with third parties, independent development or publication of information by any of Homology’s third-party collaborators. A competitor’s discovery of Homology’s trade secrets would impair its competitive position and have an adverse impact on its business.

If Homology’s trademarks and trade names are not adequately protected, then Homology may not be able to build name recognition in its markets of interest and its business may be adversely affected.

If Homology’s trademarks and trade names are not adequately protected, then Homology may not be able to build name recognition in its markets of interest and its business may be adversely affected. As of September 30, 2023, Homology owned four registered trademarks and one pending trademark applications in the United States, as well as 39 registered trademarks and five pending trademark applications in other countries around the world. Homology may not be able to protect its rights to these trademarks and trade names, which Homology needs to build name recognition among potential partners or customers in its markets of interest. At times, competitors may adopt trade names or trademarks similar to Homology’s, thereby impeding Homology’s ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of Homology’s unregistered trademarks or trade names. Over the long term, if Homology is unable to successfully register its trademarks and trade names and establish name recognition based on its trademarks and trade names, then Homology may not be able to compete effectively and its business may be adversely affected. Homology’s efforts to enforce or protect its proprietary rights related to trademarks, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely impact Homology’s financial condition or results of operations.

Homology may be subject to claims that its employees, consultants or independent contractors have wrongfully used or disclosed confidential information of their former employers or other third parties.

Homology employs individuals who were previously employed at other biotechnology or pharmaceutical companies. Although Homology seeks to protect its ownership of intellectual property rights by ensuring that its

 

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agreements with its employees, collaborators and other third parties with whom it does business include provisions requiring such parties to assign rights in inventions to Homology, Homology may be subject to claims that it or its employees, consultants or independent contractors have inadvertently or otherwise used or disclosed confidential information of Homology’s employees’ former employers or other third parties. Homology may also be subject to claims that former employers or other third parties have an ownership interest in Homology’s patents. Litigation may be necessary to defend against these claims. There is no guarantee of success in defending these claims, and if Homology fails in defending any such claims, in addition to paying monetary damages, Homology may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Even if Homology is successful, litigation could result in substantial cost and reputational loss and be a distraction to Homology’s management and other employees.

Risks Related to Employee Matters and Other Risks Related to Homology’s Business

Homology’s recent reduction in force undertaken to significantly reduce Homology’s ongoing operating expenses may not result in Homology’s intended outcomes and may yield unintended consequences and additional costs.

In July 2023, Homology implemented a reduction in force affecting approximately 80 employees, or 86% of its workforce, in order to reduce its ongoing operating costs, extend its cash runway and maximize shareholder value as it considers strategic options. In connection with corporate restructuring, Homology recorded a restructuring charge for severance and related costs of $6.9 million in its condensed consolidated statements of operations included elsewhere in this proxy statement/prospectus during the three months ended September 30, 2023. In addition, Homology had previously granted certain of the terminated employees restricted stock units that vest in annual installments based on continued service to Homology, as well as options to purchase shares of Homology’s common stock that typically vest over a period of four years. In connection with the reduction in workforce, Homology agreed to accelerate the vesting of a portion of the RSUs that were unvested as of the employees’ termination dates, and also modify the stock options for terminated employees such that subject to the satisfaction of severance conditions, the terminated employees’ vested options will remain outstanding and exercisable until the first anniversary of each employee’s termination date. These equity modifications resulted in a net reduction to stock based compensation expense of $0.3 million reflected within restructuring and other charges in Homology’s condensed consolidated statements of operations included elsewhere in this proxy statement/prospectus during the three months ended September 30, 2023.

The reduction in force may result in unintended consequences and additional costs, such as the loss of institutional knowledge and expertise, attrition beyond the intended number of employees, decreased morale among Homology’s remaining employees, and the risk that Homology may not achieve the anticipated benefits of the reduction in force. In addition, while positions have been eliminated certain functions necessary to Homology’s operations remain, and Homology may be unsuccessful in distributing the duties and obligations of departed employees among its remaining employees. The reduction in workforce could also make it difficult for Homology to pursue, or prevent Homology from pursuing, new opportunities and initiatives due to insufficient personnel, or require Homology to incur additional and unanticipated costs to hire new personnel to pursue such opportunities or initiatives. If Homology is unable to realize the anticipated benefits from the reduction in force, or if Homology experiences significant adverse consequences from the reduction in force, its business, financial condition, and results of operations may be materially adversely affected.

Homology’s future success depends on its ability to retain its key personnel and to attract, retain and motivate qualified personnel.

Homology’s industry has experienced a high rate of turnover of management personnel in recent years. Homology is highly dependent on the development, regulatory, commercialization and business development expertise of certain principal members of its management team. Although Homology has formal employment agreements with its executive officers, these agreements do not prevent them from terminating their employment with Homology at any time.

 

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Homology or the third parties upon whom Homology depends may be adversely affected by natural disasters public health emergencies and other natural catastrophic events, and Homology’s business continuity and disaster recovery plans may not adequately protect it from a serious disaster.

Natural disasters could severely disrupt Homology’s operations and have a material adverse effect on Homology’s business, results of operations, financial condition and prospects. If a natural disaster, public health emergency, such as the COVID-19 pandemic, power outage or other event occurred that prevented Homology from using all or a significant portion of its headquarters, that damaged critical infrastructure, such as its manufacturing facilities, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for Homology to continue its business for a substantial period of time. The disaster recovery and business continuity plans Homology has in place may prove inadequate in the event of a serious disaster or similar event. Homology may incur substantial expenses as a result of the limited nature of its disaster recovery and business continuity plans, which could have a material adverse effect on its business. For example, following Hurricane Maria, shortages in production and delays in a number of medical supplies produced in Puerto Rico resulted, and any similar interruption due to a natural disaster affecting Homology or any of Homology’s third-party manufacturers could materially delay Homology’s operations.

Risks Related to Homology’s Common Stock

Homology’s executive officers and directors and their respective affiliates, if they choose to act together, will continue to have the ability to control or significantly influence all matters submitted to stockholders for approval.

Homology’s executive officers and directors and their respective affiliates, in the aggregate, held shares representing approximately 11% of its outstanding voting stock as of September 30, 2023. As a result, if these stockholders choose to act together, they would be able to control or significantly influence all matters submitted to Homology’s stockholders for approval, as well as its management and affairs. For example, these persons, if they choose to act together, would control or significantly influence the election of directors, the composition of Homology’s management and approval of any merger, consolidation or sale of all or substantially all of Homology’s assets.

A significant portion of Homology’s total outstanding shares are eligible, or will soon become eligible, to be sold into the market, which could cause the market price of Homology’s common stock to drop significantly, even if Homology’s business is doing well.

Sales of a substantial number of shares of Homology’s common stock in the public market, or the perception in the market that the holders of a large number of shares intend to sell shares, could reduce the market price of Homology’s common stock. Homology has registered all shares of common stock that it may issue under its equity compensation plans, which can be freely sold in the public market upon issuance, subject to volume limitations applicable to affiliates.

Homology is an “emerging growth company,” and the reduced disclosure requirements applicable to emerging growth companies may make Homology’s common stock less attractive to investors.

Homology is an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, and may remain an emerging growth company until the last day of the fiscal year following the fifth anniversary of the closing of the initial public offering of Homology’s common stock. However, if certain events occur prior to the end of such five-year period, including if Homology becomes a “large accelerated filer,” its annual gross revenues exceed $1.235 billion or it issues more than $1.0 billion of non-convertible debt in any three-year period, Homology will cease to be an emerging growth company prior to the end of such five-year period. For so long as Homology remains an emerging growth company, Homology is permitted and intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not emerging growth companies. These exemptions include:

 

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not being required to comply with the auditor attestation requirements in the assessment of Homology’s internal control over financial reporting;

 

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not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;

 

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reduced disclosure obligations regarding executive compensation; and

 

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exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

Homology cannot predict whether investors will find its common stock less attractive if it relies on these exemptions. If some investors find Homology’s common stock less attractive as a result, there may be a less active trading market for Homology’s common stock and its stock price may be reduced or more volatile. In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an emerging growth company to delay the adoption of these accounting standards until they would otherwise apply to private companies. Homology has elected to take advantage of this extended transition period.

Provisions in Homology’s restated certificate of incorporation and amended and restated bylaws and under Delaware law could make an acquisition of Homology, which may be beneficial to Homology’s stockholders, more difficult and may prevent attempts by Homology’s stockholders to replace or remove its current management.

Provisions in Homology’s restated certificate of incorporation and its amended and restated bylaws may discourage, delay or prevent a merger, acquisition or other change in control of Homology that stockholders may consider favorable, including transactions in which you might otherwise receive a premium for your shares. These provisions could also limit the price that investors might be willing to pay in the future for shares of Homology’s common stock, thereby depressing the market price of Homology’s common stock. In addition, because Homology’s board of directors is responsible for appointing the members of its management team, these provisions may frustrate or prevent any attempts by Homology’s stockholders to replace or remove its current management by making it more difficult for stockholders to replace members of its board of directors. Among other things, these provisions include those establishing:

 

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a classified board of directors with three-year staggered terms, which may delay the ability of stockholders to change the membership of a majority of Homology’s board of directors;

 

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no cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates;

 

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the exclusive right of Homology’s board of directors to elect a director to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director, which prevents stockholders from filling vacancies on Homology’s board of directors;

 

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the ability of Homology’s board of directors to authorize the issuance of shares of preferred stock and to determine the terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquirer;

 

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the ability of Homology’s board of directors to alter its bylaws without obtaining stockholder approval;

 

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the required approval of the holders of at least two-thirds of the shares entitled to vote at an election of directors to adopt, amend or repeal Homology’s bylaws or repeal the provisions of its restated certificate of incorporation regarding the election and removal of directors;

 

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a prohibition on stockholder action by written consent, which forces stockholder action to be taken at an annual or special meeting of Homology’s stockholders;

 

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the requirement that a special meeting of stockholders may be called only by the chairman of the board of directors, the chief executive officer, the president or the board of directors, which may delay the ability of Homology’s stockholders to force consideration of a proposal or to take action, including the removal of directors; and

 

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advance notice procedures that stockholders must comply with in order to nominate candidates to Homology’s board of directors or to propose matters to be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of Homology.

Moreover, because Homology is incorporated in Delaware, Homology is governed by the provisions of Section 203 of the General Corporation Law of the State of Delaware, which prohibits a person who owns in excess of 15% of Homology’s outstanding voting stock from merging or combining with Homology for a period of three years after the date of the transaction in which the person acquired in excess of 15% of Homology’s outstanding voting stock, unless the merger or combination is approved in a prescribed manner.

Homology’s certificate of incorporation designates the Court of Chancery of the State of Delaware, subject to certain exceptions, as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by Homology’s stockholders and Homology’s bylaws designate the federal district courts of the United States as the exclusive forum for actions arising under the Securities Act of 1933, as amended, which could limit Homology’s stockholders’ ability to obtain a favorable judicial forum for disputes with Homology or its directors, officers or employees.

Homology’s restated certificate of incorporation specifies that, unless Homology consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for most legal actions involving claims brought against Homology by stockholders. In addition, Homology’s bylaws provide that the federal district courts of the United States are the exclusive forum for any complaint raising a cause of action arising under the Securities Act of 1933, as amended. Any person or entity purchasing or otherwise acquiring any interest in shares of Homology’s capital stock shall be deemed to have notice of and to have consented to the provisions of Homology’s restated certificate of incorporation and bylaws described above.

Homology believes these choice of forum provisions benefit it by providing increased consistency in the application of Delaware law by chancellors particularly experienced in resolving corporate disputes, efficient administration of cases on a more expedited schedule relative to other forums and protection against the burdens of multi-forum litigation. However, the provision may have the effect of discouraging lawsuits against Homology’s directors, officers, employees and agents as it may limit any stockholder’s ability to bring a claim in a judicial forum that such stockholder finds favorable for disputes with Homology or its directors, officers, employees or agents. The enforceability of similar choice of forum provisions in other companies’ certificates of incorporation has been challenged in legal proceedings, and it is possible that, in connection with any applicable action brought against Homology, a court could find the choice of forum provisions contained in Homology’s restated certificate of incorporation or bylaws to be inapplicable or unenforceable in such action. If a court were to find the choice of forum provisions contained in Homology’s restated certificate of incorporation or bylaws to be inapplicable or unenforceable in an action, Homology may incur additional costs associated with resolving such action in other jurisdictions, which could adversely affect its business, financial condition or results of operations.

Homology’s ability to use net operating losses and research and development credits to offset future taxable income or income tax liabilities may be subject to certain limitations.

As of December 31, 2022, Homology had federal and state net operating loss carryforwards, or NOLs, of approximately $283.5 million and $272.1 million, respectively. Homology’s state NOLs, and federal NOLs

 

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generated in taxable years beginning before January 1, 2018, are subject to expiration and will expire at various dates through 2041. Federal NOLs generated in taxable periods beginning after December 31, 2017 may be carried forward indefinitely but may only be used to offset 80% of Homology’s taxable income in taxable years beginning after December 31, 2020, which may require Homology to pay federal income taxes in future years despite generating federal NOLs in prior years. As of December 31, 2022, Homology also had federal and state research and development and other tax credit carryforwards, or credits, including the orphan drug credit, of approximately $55.1 million and $14.8 million, respectively, available to reduce or offset future taxable income. The federal and state credits expire at various dates through 2041. These NOLs and credits could expire unused and be unavailable to offset future taxable income, to the extent subject to expiration. In addition, in general, under Sections 382 and 383 of the Code, a corporation that undergoes an “ownership change” is subject to limitations on its ability to utilize its pre-change NOLs or credits to offset future taxable income. For these purposes, an ownership change generally occurs where the aggregate change in stock ownership of one or more stockholders or groups of stockholders owning at least 5% of a corporation’s stock exceeds 50 percentage points over a rolling three-year period. Homology’s existing NOLs or credits may be subject to limitations arising from previous ownership changes, if any. In addition, future changes in Homology’s stock ownership, many of which are outside of Homology’s control, could result in an ownership change. Homology’s state NOLs or credits may also be impaired or subject to limitations under state law. Accordingly, even if Homology attains profitability, it may not be able to utilize a material portion of its NOLs or credits.

Because Homology does not anticipate paying any cash dividends on its common shares in the foreseeable future, capital appreciation, if any, would be your sole source of gain.

Homology has never declared or paid any cash dividends on its common shares. Homology anticipates that it will retain future earnings for the development and operation of its business and does not anticipate declaring or paying any cash dividends for the foreseeable future. As a result, capital appreciation, if any, of Homology’s common shares would be your sole source of gain on an investment in Homology’s common shares for the foreseeable future.

General Risk Factors

The market price of Homology’s common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of Homology’s common stock.

Homology’s stock price is likely to be volatile. The stock market in general and the market for smaller biopharmaceutical companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. As a result of this volatility, you may not be able to sell your shares of common stock at or above the price at which you purchased them. The market price for Homology’s common stock may be influenced by many factors, including:

 

  •  

the success of competitive products or technologies;

 

  •  

actual or expected changes in Homology’s growth rate relative to its competitors;

 

  •  

results of clinical trials of Homology’s product candidates or those of its competitors;

 

  •  

developments related to Homology’s existing or any future collaborations;

 

  •  

regulatory actions with respect to Homology’s product candidates or its competitors’ products and product candidates;

 

  •  

regulatory or legal developments in the United States and other countries;

 

  •  

development of new product candidates that may address Homology’s markets and make its product candidates less attractive;

 

  •  

changes in physician, hospital or healthcare provider practices that may make Homology’s product candidates less useful;

 

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  •  

announcements by Homology, its collaborators or its competitors of significant acquisitions, strategic collaborations, joint ventures or capital commitments;

 

  •  

developments or disputes concerning patent applications, issued patents or other proprietary rights;

 

  •  

the recruitment or departure of key personnel;

 

  •  

the level of expenses related to any of Homology’s product candidates or clinical development programs;

 

  •  

failure to meet or exceed financial estimates and projections of the investment community or that Homology provides to the public;

 

  •  

the results of Homology’s efforts to discover, develop, acquire or in-license additional product candidates or products;

 

  •  

actual or expected changes in estimates as to financial results, development timelines or recommendations by securities analysts;

 

  •  

variations in Homology’s financial results or those of companies that are perceived to be similar to Homology;

 

  •  

changes in the structure of healthcare payment systems;

 

  •  

market conditions in the pharmaceutical and biotechnology sectors;

 

  •  

general economic, industry and market conditions; and

 

  •  

the other factors described in this “Risk Factors” section.

Homology expects to continue to incur costs as a result of operating as a public company, and Homology’s management is required to devote substantial time to new compliance initiatives and corporate governance practices.

As a public company, Homology has incurred and expect to continue to incur significant legal, accounting and other expenses that Homology did not incur as a private company. The Sarbanes-Oxley Act of 2002, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of the Nasdaq and other applicable securities rules and regulations impose various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Homology’s management and other personnel devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations have increased Homology’s legal and financial compliance costs and have made some activities more time-consuming and costly. For example, Homology expects that these rules and regulations may make it more difficult and more expensive for Homology to obtain director and officer liability insurance, which in turn could make it more difficult for Homology to attract and retain qualified members of its board of directors.

Homology continues to evaluate these rules and regulations, and cannot predict or estimate the amount of additional costs it may incur or the timing of such costs. These rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

Pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, or Section 404, Homology is required to furnish a report by its management on its internal control over financial reporting. However, while Homology remains an emerging growth company, it will not be required to include an attestation report on internal control over financial reporting issued by its independent registered public accounting firm. To achieve compliance with

 

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Section 404 within the prescribed period, Homology has engaged in a process to document and evaluate its internal control over financial reporting, which has been both costly and challenging. Homology will need to continue to dedicate internal resources, engage outside consultants, adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing whether such controls are functioning as documented, and implement a continuous reporting and improvement process for internal control over financial reporting. Despite Homology’s efforts, there is a risk that it will not be able to conclude that its internal control over financial reporting is effective as required by Section 404. If Homology identifies one or more material weaknesses, it could cause Homology to need to restate its previously issued financial statements and result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of its financial statements.

There can be no assurance that Homology will be able to comply with the continued listing standards of Nasdaq.

If Homology fails to satisfy Nasdaq’s continued listing requirements, Nasdaq may take steps to delist Homology’s securities. Such a delisting would likely have a negative effect on the price of the securities and would impair stockholders’ ability to sell or purchase the securities when they wish to do so. In the event of a delisting, Homology can provide no assurance that any action taken by it to restore compliance with listing requirements would allow its securities to become listed again, stabilize the market price or improve the liquidity of its securities, or prevent future non-compliance with Nasdaq’s listing requirements.

In the future, Homology may engage in acquisitions that could disrupt its business, cause dilution to its stockholders or reduce its financial resources.

In the future, Homology may enter into transactions to acquire other businesses, products or technologies. If Homology does identify suitable candidates, it may not be able to make such acquisitions on favorable terms, or at all. Any acquisitions Homology make may not strengthen its competitive position, and these transactions may be viewed negatively by customers or investors. Homology may decide to incur debt in connection with an acquisition or issue its common stock or other equity securities to the stockholders of the acquired company, which would reduce the percentage ownership of its existing stockholders. Homology could incur losses resulting from undiscovered liabilities of the acquired business that are not covered by the indemnification Homology may obtain from the seller. In addition, Homology may not be able to successfully integrate the acquired personnel, technologies and operations into its existing business in an effective, timely and nondisruptive manner. Acquisitions may also divert management attention from day-to-day responsibilities, increase Homology’s expenses and reduce its cash available for operations and other uses. Homology cannot predict the number, timing or size of future acquisitions or the effect that any such transactions might have on its operating results.

Unstable global political or economic conditions may have serious adverse consequences on Homology’s business, financial condition and share price.

The global economy, including credit and financial markets, has recently experienced extreme volatility and disruptions, including severely diminished liquidity and credit availability, rising interest and inflation rates, declines in consumer confidence, declines in economic growth, increases in unemployment rates and uncertainty about economic stability. There can be no assurance that further deterioration in credit and financial markets and confidence in economic conditions will not occur. If the equity and credit markets continue to deteriorate, or the United States enters a recession, it may make any necessary debt or equity financing more difficult to obtain in a timely manner or on favorable terms, more costly or more dilutive. In addition, international terrorism and conflicts could disrupt or otherwise adversely impact Homology’s operations and those of third parties upon which Homology relies. Related sanctions, export controls or other actions have and may in the future be initiated by nations including the U.S., the EU or Russia (e.g., potential cyberattacks, disruption of energy flows, etc.), which could adversely affect Homology’s business and/or its supply chain, its CROs, CMOs and other third parties with which it conducts business. Any of the foregoing could harm Homology’s business, results of operations and the price of Homology’s common stock may be adversely affected.

 

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Homology is exposed to fluctuations in inflation, which could negatively affect Homology’s business, financial condition and results of operations.

The United States has recently experienced historically high levels of inflation. According to the U.S. Department of Labor, the annual inflation rate for the United States was approximately 8.0% for 2022. If the inflation rate continues to increase, it will likely affect Homology’s expenses, including, but not limited to, increased cost of drug product from OXB Solutions and other future potential contract manufacturing organizations, supplies and employee compensation expenses. To the extent inflation results in rising interest rates and has other adverse effects on the market, it may adversely affect Homology’s business, financial condition and results of operations.

The increasing focus on environmental sustainability and social initiatives could increase Homology’s costs, harm its reputation and adversely impact its financial results.

There has been increasing public focus by investors, environmental activists, the media and governmental and nongovernmental organizations on a variety of environmental, social and other sustainability matters. Homology may experience pressure to make commitments relating to sustainability matters that affect it, including the design and implementation of specific risk mitigation strategic initiatives relating to sustainability. If Homology is not effective in addressing environmental, social and other sustainability matters affecting its business, or setting and meeting relevant sustainability goals, its reputation and financial results may suffer. In addition, Homology may experience increased costs in order to execute upon its sustainability goals and measure achievement of those goals, which could have an adverse impact on its business and financial condition.

Moreover, this emphasis on environmental, social and other sustainability matters has resulted and may result in the adoption of new laws and regulations, including new reporting requirements. If Homology fails to comply with new laws, regulations or reporting requirements, its reputation and business could be adversely impacted.

Risks Related to Q32’s Business

Risks Related to Q32’s Limited Operating History, Financial Position and Need for Capital

Q32 has incurred significant losses since inception, expects to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future. Q32 has no products for sale, has not generated any product revenue and may never generate product revenue or become profitable.

Investment in biotechnology product development is a highly speculative undertaking and entails substantial upfront expenditures and significant risks that any program will fail to demonstrate adequate efficacy or an acceptable safety profile, gain regulatory approval and become commercially viable. Q32 has no products approved for commercial sale, Q32 has not generated any revenue from product sales to date and Q32 continues to incur significant research and development and other expenses related to its ongoing operations. Q32 does not expect to generate product revenue unless or until it successfully completes clinical development and obtains regulatory approval of, and then successfully commercializes, at least one product candidate. Q32 may never succeed in these activities and, even if it does, may never generate product revenue or revenues that are significant or large enough to achieve profitability. If Q32 is unable to generate sufficient revenue through the sale of any approved products, it may be unable to continue operations without additional funding.

Q32 has incurred significant net losses in each period since it commenced operations in 2017. Q32’s net loss was $26.7 million for the nine months ended September 30, 2023, and $42.8 million and $37.6 million for the years ended December 31, 2022 and 2021, respectively. As of September 30, 2023, Q32 had an accumulated deficit of $160.0 million. Q32 expects to continue to incur significant losses for the foreseeable future. Its operating expenses and net losses may fluctuate significantly from quarter to quarter and year to year. Q32 anticipates that its expenses will increase substantially if and as it:

 

  •  

advances its existing and future programs through preclinical and clinical development, including expansion into additional indications;

 

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  •  

seeks to identify additional programs and additional product candidates;

 

  •  

maintains, expands, enforces, defends and protects its intellectual property portfolio;

 

  •  

seeks regulatory and marketing approvals for product candidates;

 

  •  

seeks to identify, establish and maintain additional collaborations and license agreements;

 

  •  

ultimately establishes a sales, marketing and distribution infrastructure to commercialize any drug products for which Q32 may obtain marketing approval, either by itself or in collaboration with others;

 

  •  

commences commercial sales of products for which Q32 receives marketing approval;

 

  •  

hires additional personnel including research and development, clinical and commercial;

 

  •  

adds operational, financial and management information systems and personnel, including personnel to support product development;

 

  •  

acquires or in-licenses products, intellectual property and technologies; and

 

  •  

establishes commercial-scale current good manufacturing practices, or cGMP, capabilities through a third-party or its own manufacturing facility.

In addition, Q32’s expenses will increase if, among other things, it is required by the FDA or other regulatory authorities to perform trials or studies in addition to, or different than, those that Q32 currently anticipates, there are any delays in completing its clinical trials or the development of any product candidates, or there are any third-party challenges to its intellectual property or it needs to defend against any intellectual property-related claim.

Even if Q32 obtains marketing approval for, and is successful in commercializing, one or more product candidates, Q32 expects to incur substantial additional research and development and other expenditures to develop and market additional programs and/or to expand the approved indications of any marketed product. Q32 may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect its business. The size of its future net losses will depend, in part, on the rate of future growth of its expenses and its ability to generate revenue.

Q32’s failure to become profitable would decrease the value of the company and could impair its ability to raise capital, maintain its research and development efforts, expand its business and/or continue its operations. A decline in the value of Q32 could also cause you to lose all or part of your investment.

In addition, management have evaluated adverse conditions and events that raise substantial doubt about Q32’s ability to continue as a going concern, and its independent registered public accounting firm included an explanatory paragraph in its report on its financial statements as of and for the year ended December 31, 2022 included elsewhere herein with respect to this uncertainty. This substantial doubt about Q32’s ability to continue as a going concern could materially limit its ability to raise additional funds through the issuance of new debt or equity securities or otherwise. Future reports on its financial statements may include an explanatory paragraph with respect to its ability to continue as a going concern. Even if the Merger and Q32’s Pre-Closing Financing are successfully completed, there is no assurance that adequate additional financing needed to allow Q32 to continue as a going concern will be available to it on acceptable terms, or at all. The perception that Q32 may not be able to continue as a going concern may cause others to choose not to do business with Q32 due to concerns about its ability to meet its contractual obligations.

Even if the Merger and Q32’s Pre-Closing Financing are successful, Q32 will require substantial additional capital to finance its operations in the future. If Q32 is unable to raise such capital when needed, or on acceptable terms, Q32 may be forced to delay, reduce or eliminate clinical trials, product development programs or future commercialization efforts.

Developing biotechnology products is a very long, time-consuming, expensive and uncertain process that takes years to complete. Since its inception, Q32 has funded its operations primarily through private equity and

 

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debt financings and has incurred significant recurring losses. Q32 expects its expenses to increase in connection with its ongoing activities, particularly as Q32 conducts its clinical trials for bempikibart (ADX-914) and ADX-097, initiates additional clinical trials, and continues to research, develop and conduct preclinical studies of its other potential product candidates, and begins to operate as a public company. In addition, if Q32 obtains regulatory approval for any product candidate for commercial sale, including bempikibart or ADX-097, Q32 anticipates incurring significant commercialization expenses related to product manufacturing, marketing, sales and distribution activities to launch any such product. Q32’s expenses could increase beyond expectations if Q32 is required by the FDA or other regulatory agencies to perform preclinical studies or clinical trials in addition to those that Q32 currently anticipates. Because the design and outcome of its current, planned and anticipated clinical trials are highly uncertain, and many of Q32’s near-term plans are subject to regulatory feedback, Q32 cannot reasonably estimate the actual amount of funding that will be necessary to successfully complete the development and commercialization of any product candidate Q32 develops. Q32’s future capital requirements depend on many factors, including factors that are not within its control.

Following the Merger and Q32’s Pre-Closing Financing, Q32 will also incur additional costs associated with operating as a public company. Accordingly, Q32 will require substantial additional funding to continue its operations. Based on its current operating plan, and assuming the Merger and Q32’s Pre-Closing Financing are successfully completed, Q32 believes that its existing cash, cash equivalents and short-term investments should be sufficient to fund its operations to mid-2026. This estimate is based on assumptions that may prove to be materially wrong, and Q32 could use its available capital resources sooner than it currently expects. Q32’s future capital requirements will depend on many factors, including:

 

  •  

the timing and progress of preclinical and clinical development activities, including its ongoing Phase 2 clinical trials for bempikibart in atopic dermatitis, or AD, and alopecia areata, or AA, its planned renal basket program in lupus nephritis, or LN, immunoglobulin A, or IgA, nephropathy, or IgAN and complement component 3 glomerulopathy, or C3G, and its planned Phase 2 clinical trial for ADX-097 in anti-neutrophil cytoplasmic antibody, or ANCA, -associated vasculitis, or AAV;

 

  •  

the number and scope of preclinical and clinical programs Q32 pursues;

 

  •  

its ability to establish an acceptable safety profile with IND-enabling toxicology studies to enable clinical trials;

 

  •  

successful patient enrollment in, and the initiation and completion of, larger and later-stage clinical trials;

 

  •  

per subject trial costs;

 

  •  

the number and extent of trials required for regulatory approval;

 

  •  

the countries in which the trials are conducted;

 

  •  

the length of time required to enroll eligible subjects in clinical trials;

 

  •  

the number of subjects that participate in the trials;

 

  •  

the drop-out and discontinuation rate of subjects;

 

  •  

potential additional safety monitoring requested by regulatory agencies;

 

  •  

the duration of subject participation in the trials and follow-up;

 

  •  

the extent to which Q32 encounters any serious adverse events in its clinical trials;

 

  •  

the timing of receipt of regulatory approvals from applicable regulatory authorities;

 

  •  

the timing, receipt and terms of any marketing approvals and post-marketing approval commitments from applicable regulatory authorities;

 

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  •  

the extent to which Q32 establishes or maintains collaborations, strategic partnerships, or other strategic arrangements with third parties, if any, and the performance of any such third parties in connection therewith;

 

  •  

hiring and retaining research and development personnel;

 

  •  

its arrangements with its contract development and manufacturing organizations and contract research organizations, or CROs;

 

  •  

development and timely delivery of clinical and commercial-grade drug formulations that can be used in its planned clinical trials and for commercial launch, respectfully;

 

  •  

the impact of any business interruptions to its operations or to those of the third parties with whom Q32 works; and

 

  •  

obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights.

Adequate additional financing may not be available to Q32 on acceptable terms, or at all, and Q32 may be required to seek additional funds sooner than planned through public or private equity offerings, debt financings, collaborations and licensing arrangements or other sources. Such financing may dilute its stockholders or the failure to obtain such financing may restrict its operating activities. Any additional fundraising efforts may divert Q32’s management from their day-to-day activities, which may adversely affect its business. To the extent that Q32 raises additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences and anti-dilution protections that adversely affect your rights as a stockholder. Debt financing or refinancing may result in imposition of debt covenants, increased fixed payment obligations or other restrictions that may affect Q32’s business. If Q32 raises additional funds through upfront payments or milestone payments pursuant to future collaborations with third parties, Q32 may have to relinquish valuable rights to product development programs, or grant licenses on terms that are not favorable to it. Q32’s ability to raise additional capital may be adversely impacted by global macroeconomic conditions and volatility in the credit and financial markets in the U.S. and worldwide, over which Q32 may have no or little control. Its failure to raise capital as and when needed or on acceptable terms would have a negative impact on its financial condition and its ability to pursue its business strategy, and Q32 may have to delay, reduce the scope of, suspend or eliminate clinical trials, product development programs or future commercialization efforts.

Q32 has a limited operating history and has no products approved for commercial sale, which may make it difficult for you to evaluate its current business and likelihood of success and viability.

Q32 is a clinical-stage biotechnology company with limited operating history. Since its inception in 2017, Q32 has incurred significant operating losses and has utilized substantially all of its resources to conduct research and development activities (including with respect to its bempikibart and ADX-097 programs) and undertake preclinical studies of product candidates, as well as for conducting clinical trials of Q32’s most advanced product candidates and the manufacturing of such product candidates, business planning, developing and maintaining its intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these activities. Q32 has limited significant experience as a company in initiating, conducting or completing clinical trials. In part because of this lack of experience, Q32 cannot be certain that its current and planned clinical trials will begin or be completed on time, if at all. Q32 has not yet demonstrated its ability to successfully complete Phase 3 or other pivotal clinical trials, obtain regulatory or marketing approvals, manufacture a commercial-scale product or arrange for a third party to do so on its behalf, or conduct sales, marketing and distribution activities necessary for successful product commercialization. Additionally, Q32 expects its financial condition and operating results to continue to fluctuate significantly from period to period due to a variety of factors, many of which are beyond its control. Consequently, any predictions made about Q32’s future success or viability may not be as accurate as they could be if Q32 had a longer operating history.

In addition, as its business grows, Q32 may encounter unforeseen expenses, restrictions, difficulties, complications, delays and other known and unknown factors. Q32 will need to transition at some point from a

 

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company with an early research and development focus to a company capable of supporting larger scale clinical trials and eventually commercial activities. Q32 may not be successful in such a transition.

Risks Related to Discovery, Development and Commercialization

Q32 faces competition from entities that have developed or may develop programs for the diseases it plans to address with bempikibart, ADX-097 or other product candidates.

The development and commercialization of drugs and biologics is highly competitive. Q32’s product candidates may compete with other product candidates in development for similar indications, and if approved, bempikibart, ADX-097 or other product candidates will face significant competition and Q32’s failure to effectively compete may prevent it from achieving significant market penetration. Q32 competes with a variety of multinational biopharmaceutical companies, specialized biotechnology companies and emerging biotechnology companies, as well as academic institutions, governmental agencies, and public and private research institutions, among others. Many of the companies with which Q32 is currently competing or will compete against in the future have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals, and marketing approved products than Q32 does. Mergers and acquisitions in the pharmaceutical and biotechnology industry may result in even more resources being concentrated among a smaller number of its competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with Q32 in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites, patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, bempikibart, ADX-097 or other product candidates.

Q32’s competitors have developed, are developing or may develop programs and processes competitive with bempikibart, ADX-097 or other product candidates and processes. Competitive therapeutic treatments include those that have already been approved and accepted by the medical community and any new treatments. Q32’s success will depend partially on its ability to develop and commercialize products that have a competitive safety, efficacy, dosing and/or presentation profile. Q32’s commercial opportunity and success will be reduced or eliminated if competing products are safer, more effective, have a more attractive dosing profile or presentation or are less expensive than any products Q32 may develop, if any, or if competitors develop competing products or if generic products or biosimilars enter the market more quickly than Q32 is able to, if at all, and are able to gain market acceptance.

Bempikibart, ADX-097 and Q32’s pipeline are in early stages of development and may fail in development or suffer delays that materially and adversely affect their commercial viability. If Q32 or its current or future collaborators are unable to complete development of, or commercialize, Q32’s product candidates, or experience significant delays in doing so, its business will be materially harmed.

Q32 has no products on the market and bempikibart, ADX-097 and Q32’s pipeline are in the early stages of development. As a result, Q32 expects it will be many years before it commercializes any product candidate, if any. Q32’s ability to achieve and sustain profitability depends on obtaining regulatory approvals for, and successfully commercializing, bempikibart, ADX-097 or other product candidates either alone or with third parties, and Q32 cannot guarantee that it will ever obtain regulatory approval for any product candidates. Q32 has limited experience as a company in conducting and managing the clinical trials necessary to obtain regulatory approvals, including approval by the FDA or comparable foreign regulatory authorities. Q32 has also not yet demonstrated its ability to obtain regulatory approvals, manufacture a commercial scale product or arrange for a third party to do so on its behalf, or conduct sales and marketing activities necessary for successful product commercialization. Before obtaining regulatory approval for the commercial distribution of product candidates, Q32 or an existing or future collaborator must conduct extensive preclinical tests and clinical trials to demonstrate the safety and efficacy in humans of such product candidates.

 

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Q32 or its collaborators may experience delays in initiating or completing clinical trials. Q32 or its collaborators also may experience numerous unforeseen events during, or as a result of, any current or future clinical trials that could delay or prevent Q32’s ability to receive marketing approval or commercialize bempikibart, ADX-097 or any other product candidates, including:

 

  •  

regulators or IRBs, the FDA or ethics committees may not authorize Q32 or its investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;

 

  •  

Q32 may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and prospective CROs, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

 

  •  

clinical trial sites deviating from trial protocol or dropping out of a trial;

 

  •  

clinical trials of any product candidates may fail to show safety or efficacy, produce negative or inconclusive results and Q32 may decide, or regulators may require Q32, to conduct additional preclinical studies or clinical trials or Q32 may decide to abandon product development programs;

 

  •  

the number of subjects required for clinical trials of any Q32’s product candidates may be larger than it anticipates, especially if regulatory bodies require completion of non-inferiority or superiority trials compared to approved products, enrollment in these clinical trials may be slower than Q32 anticipates or subjects may drop out of these clinical trials or fail to return for post-treatment follow-up at a higher rate than Q32 anticipates;

 

  •  

Q32’s third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to Q32 in a timely manner, or at all, or may deviate from the clinical trial protocol or drop out of the trial, which may require that Q32 add new clinical trial sites or investigators;

 

  •  

Q32 may elect to, or regulators, IRBs or ethics committees may require that Q32 or its investigators, suspend or terminate clinical research or trials for various reasons, including noncompliance with regulatory requirements or a finding that the participants in its trials are being exposed to unacceptable health risks;

 

  •  

the cost of clinical trials of any of Q32’s product candidates may be greater than it anticipates;

 

  •  

the quality of Q32’s product candidates or other materials necessary to conduct clinical trials of its product candidates may be inadequate to initiate or complete a given clinical trial;

 

  •  

Q32’s inability to manufacture sufficient quantities of its product candidates for use in clinical trials;

 

  •  

reports from clinical testing of other therapies may raise safety or efficacy concerns about its product candidates;

 

  •  

Q32’s failure to establish an appropriate safety profile for a product candidate based on clinical or preclinical data for such product candidate as well as data emerging from other therapies in the same class as its product candidates; and

 

  •  

the FDA or other regulatory authorities may require Q32 to submit additional data such as long-term toxicology studies or impose other requirements before permitting Q32 to initiate a clinical trial.

Commencing clinical trials in the U.S. is subject to the FDA allowing an IND to proceed after an evaluation of the proposed clinical trial design. In the event that the FDA requires Q32 to complete additional preclinical studies or Q32 is required to satisfy other FDA requests prior to commencing clinical trials, the start of its clinical trials may be delayed. Even after Q32 receives and incorporates guidance from the FDA, the FDA could disagree that Q32 has satisfied their requirements to commence any clinical trial or change their position on the acceptability of its trial design or the clinical endpoints selected, which may require Q32 to complete additional preclinical studies or clinical trials, delay the enrollment of its clinical trials or impose stricter approval conditions than Q32 currently expects. There are comparable processes and risks applicable to clinical trial applications needed to initiate clinical trials in other countries, including countries in the European Union, or EU.

 

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Q32 may not have the financial resources to continue development of, or to modify existing or enter into new collaborations for, a product candidate if Q32 experiences any issues that delay or prevent regulatory approval of, or its ability to commercialize, bempikibart, ADX-097 or any other product candidates. Q32 or its current or future collaborators’ inability to complete development of, or commercialize, bempikibart, ADX-097 or any other product candidates or significant delays in doing so, could have a material and adverse effect on its business, financial condition, results of operations and prospects.

Q32 is substantially dependent on the success of its most advanced product candidates, bempikibart and ADX-097, and its clinical trials of such candidates may not be successful.

Q32’s future success is substantially dependent on its, or its current or future strategic partners’, ability to timely obtain marketing approval for, and then successfully commercialize, its most advanced product candidates, bempikibart and ADX-097. Q32 is investing a majority of its efforts and financial resources into the research and development of these candidates. Q32 is developing bempikibart to treat autoimmune and inflammatory diseases, with the aim of achieving the optimal balance of efficacy, tolerability and convenience for patients via infrequently administered subcutaneous doses. Q32 has completed a Phase 1 double-blind, placebo-controlled, single ascending dose and multiple dose study to assess the safety, PK, and PD of bempikibart after subcutaneous administration in healthy subjects. This study supported further evaluation of bempikibart, including through demonstration of a PK/PD profile supporting evaluation of every two-week subcutaneous dosing in clinical trials. Subsequent to this study, Q32 advanced bempikibart into two Phase 2 clinical trials in atopic dermatitis and alopecia areata. Both trials are currently in the dosing phase, and Q32 expects to complete both studies in 2024. The success of bempikibart may depend on having a comparable safety and efficacy profile and a more favorable dosing schedule (i.e., less frequent dosing) with patient-friendly administration (i.e., S.C. self-administration) to products currently approved or in development for the indications Q32 plans to pursue.

Q32 has completed a Phase 1 clinical trial in healthy volunteers of ADX-097 and, pending clearance of any regulatory approvals, Q32 anticipates initiating a renal basket program in LN, IgAN, C3G in the first half of 2024 and a Phase 2 clinical trial in AAV in the first quarter of 2025. The success of ADX-097 may depend on having a comparable safety and efficacy profile and a more convenient dosing schedule (i.e., less frequent dosing) with patient-friendly administration (i.e., SC self-administration) to products currently approved or in development for the indications Q32 plans to pursue.

Bempikibart and ADX-097 will require additional clinical development, evaluation of clinical and manufacturing activities, marketing approval in multiple jurisdictions, substantial investment and significant marketing efforts before Q32 generates any revenues from product sales, if any. Q32 is not permitted to market or promote these product candidates, or any other product candidates, before it receives marketing approval from the FDA and/or comparable foreign regulatory authorities, and Q32 may never receive such marketing approvals.

The success of bempikibart and ADX-097 will depend on a variety of factors. Q32 does not have complete control over many of these factors, including certain aspects of clinical development and the regulatory submission process, potential threats to its intellectual property rights and the manufacturing, marketing, distribution and sales efforts of any current or future collaborator or other third party. Accordingly, Q32 cannot guarantee that Q32 will ever be able to generate revenue through the sale of these candidates, even if approved. If Q32 is not successful in commercializing bempikibart or ADX-097, or is significantly delayed in doing so, its business will be materially harmed.

If Q32 does not achieve its projected development goals in the time frames Q32 announces and expects, the commercialization of bempikibart, ADX-097 or any other product candidates may be delayed.

From time to time, Q32 estimates the timing of the anticipated accomplishment of various scientific, clinical, regulatory and other product development goals, which Q32 sometimes refers to as milestones. These

 

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milestones may include the commencement or completion of scientific studies, preclinical studies and clinical trials and the submission of regulatory filings. From time to time, Q32 may publicly announce the expected timing of some of these milestones. All of these milestones are and will be based on numerous assumptions. The actual timing of these milestones can vary dramatically compared to Q32’s estimates, in some cases for reasons beyond Q32’s control. If Q32 does not meet these milestones as publicly announced, or at all, the commercialization of bempikibart, ADX-097 or any other product candidates may be delayed or never achieved.

Q32’s approach to the discovery and development of product candidates is unproven, and Q32 may not be successful in its efforts to build a pipeline of product candidates with commercial value.

Q32’s approach to the discovery and/or development of bempikibart and ADX-097 leverages the understanding of complement and cytokine biology in diverse tissues and indications. Bempikibart is directed at target pathways, IL-7 and TSLP signaling, that have been implicated in several inflammatory and autoimmune diseases. ADX-097 is purposefully designed to improve upon currently approved complement inhibiting products by providing inhibition of complement in a tissue-targeted manner. However, the scientific research that forms the basis of efforts to develop bempikibart and ADX-097 is ongoing and has not been successfully proven in clinical trials. The long-term safety and exposure profile of bempikibart and ADX-097 is also unknown.

Q32 may ultimately discover that its technologies for its specific targets and indications and bempikibart, ADX-097 or any product candidates resulting therefrom do not possess certain properties required for therapeutic effectiveness Q32 currently has only data from its Phase 1 clinical trial and blinded data from its Phase 2 Part A AD clinical trial related to bempikibart, and only data from its Phase 1 clinical trial regarding properties of ADX-097, and the same data or results may not be seen in larger, later-stage clinical trials. In addition, product candidates using investigational technologies and approaches may demonstrate different chemical and pharmacological properties in patients than they do in laboratory studies and bempikibart and ADX-097 may interact with human biological systems in unforeseen, ineffective or possibly harmful ways.

In addition, Q32 may in the future seek to discover and develop product candidates that are based on novel targets and technologies that are unproven. If its discovery activities fail to identify novel targets or technologies for drug discovery, or such targets prove to be unsuitable for treating human disease, Q32 may not be able to develop viable additional product candidates. Q32 and its existing or future collaborators may never receive approval to market and commercialize bempikibart, ADX-097 or future product candidates. Even if Q32 or an existing or future collaborator obtains regulatory approval, the approval may be for targets, disease indications or patient populations that are not as broad as Q32 intended or desired or may require labeling that includes significant use or distribution restrictions or safety warnings. If the products resulting from bempikibart, ADX-097 or any other product candidates prove to be ineffective, unsafe or commercially unviable, Q32’s product candidates and pipeline may have little, if any, value, which may have a material and adverse effect on its business, financial condition, results of operations and prospects.

Preclinical and clinical development involves a lengthy and expensive process that is subject to delays and with uncertain outcomes, and results of earlier studies and trials may not be predictive of future clinical trial results. If Q32’s preclinical studies and clinical trials are not sufficient to support regulatory approval of any of its product candidates, Q32 may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of such product candidate.

Before obtaining marketing approval from regulatory authorities for the sale of any product candidate, Q32 must complete preclinical studies and then conduct extensive clinical trials to demonstrate the safety and efficacy of its product candidate in humans. Q32’s clinical trials may not be conducted as planned or completed on schedule, if at all, and failure can occur at any time during the preclinical study or clinical trial process. For example, Q32 depends on the availability of NHPs to conduct certain preclinical studies that Q32 is required to complete prior to submitting an IND and initiating clinical development. There is currently a global shortage of certain types of NHPs available for GLP testing for drug development. This could cause the cost of obtaining

 

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NHPs for Q32’s future preclinical studies to increase significantly, and if the shortage continues, and could result in delays to Q32’s development timelines. Furthermore, a failure of one or more clinical trials can occur at any stage of testing. The outcome of preclinical studies and early-stage clinical trials may not be predictive of the success of later clinical trials. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their product candidates. In addition, Q32 expects to rely on patients to provide feedback on measures, which are subjective and inherently difficult to evaluate. These measures can be influenced by factors outside of its control, and can vary widely from day to day for a particular patient, and from patient to patient and from site to site within a clinical trial.

Although Q32 plans to seek regulatory guidance in designing and conducting its development plans, Q32 cannot be sure, that the FDA or comparable foreign regulatory authorities will agree with these plans. If the FDA or comparable regulatory authorities requires Q32 to revise or amend a clinical study, generate additional pre-clinical data in support of clinical conduct (e.g., toxicology studies), conduct additional trials or enroll additional patients, its development timelines may be delayed. Q32 cannot be sure that submission of an IND application, CTA or similar application will result in the FDA or comparable foreign regulatory authorities, as applicable, allowing clinical trials to begin in a timely manner, if at all. Moreover, even if these trials begin, issues may arise that could cause regulatory authorities to suspend or terminate such clinical trials. Events that may prevent successful or timely initiation or completion of clinical trials include:

 

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inability to generate sufficient preclinical, toxicology or other in vivo or in vitro data to support the initiation or continuation of clinical trials;

 

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delays in reaching a consensus with regulatory authorities on study design or implementation of the clinical trials;

 

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delays or failure in obtaining regulatory authorization to commence a trial;

 

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delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites;

 

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delays in identifying, recruiting and training suitable clinical investigators;

 

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delays in obtaining required IRB or ethics committee approval at each clinical trial site;

 

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difficulties in patient enrollment in Q32’s clinical trials for a variety of reasons;

 

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delays in manufacturing, testing, releasing, validating or importing/exporting sufficient stable quantities of its product candidates for use in clinical trials or the inability to do any of the foregoing;

 

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failure by its CROs, other third parties or Q32 to adhere to clinical trial protocols;

 

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failure to perform in accordance with the FDA’s or any other regulatory authority’s Good Clinical Practices, or GCPs, or regulations or applicable regulations or regulatory guidelines in other countries;

 

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changes to the clinical trial protocols; clinical sites deviating from trial protocol or dropping out of a trial;

 

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changes in regulatory requirements and guidance that require amending or submitting new clinical protocols;

 

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selection of clinical endpoints that require prolonged periods of observation or analyses of resulting data;

 

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transfer of manufacturing processes to larger-scale facilities operated by a CMO and delays or failure by its CMOs or Q32 to make any necessary changes to such manufacturing process; and

 

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third parties being unwilling or unable to satisfy their contractual obligations to Q32.

 

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Q32 could also encounter delays if a clinical trial is placed on clinical hold, suspended or terminated by Q32, the FDA, the competent authorities of the EU Member States or other regulatory authorities or the IRBs or ethics committees of the institutions in which such trials are being conducted, if a clinical trial is recommended for suspension or termination by the data safety monitoring board, or DSMB, or equivalent body for such trial, or on account of changes to federal, state, or local laws. If Q32 is required to conduct additional clinical trials or other testing of bempikibart, ADX-097 or any other product candidates beyond those that Q32 contemplates, if Q32 is unable to successfully complete clinical trials of bempikibart, ADX-097 or any other product candidates, if the results of these trials are not positive or are only moderately positive or if there are safety concerns, its business and results of operations may be adversely affected and Q32 may incur significant additional costs.

Q32 may not be successful in its efforts to identify or discover additional product candidates in the future.

A key part of Q32’s long-term business strategy is to identify and develop additional product candidates. Its preclinical research and clinical trials may initially show promise in identifying potential product candidates yet fail to yield product candidates for clinical development for a number of reasons. For example, Q32 may be unable to identify or design additional product candidates with the pharmacological and pharmacokinetic drug properties that Q32 desires, including, but not limited to, adequate tissue targeting, acceptable safety profile or the potential for the product candidate to be delivered in a convenient formulation. Research programs to identify new product candidates require substantial technical, financial, and human resources. If Q32 is unable to identify suitable complement targeting strategies for preclinical and clinical development, Q32 may not be able to successfully implement its business strategy, and may have to delay, reduce the scope of, suspend or eliminate one or more of its product candidates, clinical trials or future commercialization efforts, which would negatively impact its financial condition.

If Q32 encounters difficulties enrolling patients in its future clinical trials, its clinical development activities could be delayed or otherwise adversely affected.

Q32 may experience difficulties in patient enrollment in its future clinical trials for a variety of reasons. The timely completion of clinical trials in accordance with their protocols depends, among other things, on the ability to enroll a sufficient number of patients who remain in the trial until its conclusion. The enrollment of patients in future trials for bempikibart, ADX-097 or any other product candidates will depend on many factors, including if patients choose to enroll in clinical trials, rather than using approved products, or if its competitors have ongoing clinical trials for product candidates that are under development for the same indications as Q32’s product candidates, and patients instead enroll in such clinical trials. Additionally, the number of patients required for clinical trials of bempikibart, ADX-097 or any other product candidates may be larger than Q32 anticipates, especially if regulatory bodies require the completion of non-inferiority or superiority trials compared to approved products. Even if Q32 is able to enroll a sufficient number of patients for its future clinical trials, Q32 may have difficulty maintaining patients in its clinical trials. Its inability to enroll or maintain a sufficient number of patients would result in significant delays in completing clinical trials or receipt of marketing approvals and increased development costs or may require Q32 to abandon one or more clinical trials altogether.

Preliminary, “topline” or interim data from its clinical trials that Q32 announces or publishes from time to time may change as more patient data becomes available and are subject to audit and verification procedures.

From time to time, Q32 may publicly disclose preliminary or topline data from its preclinical studies and clinical trials, which are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data. Q32 also makes assumptions, estimations, calculations and conclusions as part of its analyses of these data without the opportunity to fully and carefully evaluate complete data. As a result, the preliminary or topline results that Q32 report may differ from future results of the same studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated or subsequently made subject to audit and verification procedures. Any preliminary or topline data should be viewed with caution until the final data is

 

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available. From time to time, Q32 may also disclose interim data from its preclinical studies and clinical trials. Interim data are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available or as patients from its clinical trials continue other treatments.

Further, others, including regulatory agencies, may not accept or agree with its assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular product candidate, the approvability or commercialization of a particular product candidate and Q32 in general. In addition, the information Q32 chooses to publicly disclose regarding a particular preclinical study or clinical trial is based on what is typically extensive information, and you or others may not agree with what Q32 determines is material or otherwise appropriate information to include in its disclosure. If the preliminary, topline or interim data that Q32 reports differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, Q32’s ability to obtain approval for, and commercialize, bempikibart, ADX-097 or any other product candidate may be harmed, which could harm its business, operating results, prospects or financial condition.

Q32’s current or future clinical trials or those of its future collaborators may reveal significant adverse events or undesirable side effects not seen in its preclinical and/or early clinical studies and may result in a safety profile that could halt clinical development, inhibit regulatory approval or limit commercial potential or market acceptance of any of bempikibart, ADX-097 or any other product candidates or result in potential product liability claims.

Results of Q32’s clinical trials could reveal a high and unacceptable severity and prevalence of side effects, adverse events or unexpected characteristics. While Q32’s completed preclinical studies and its completed and ongoing clinical trials in humans have not shown any such characteristics to date, significant further evaluation must be done of each of Q32’s product candidates. If significant adverse events or other side effects are observed in any of its current or future clinical trials, Q32 may have difficulty recruiting patients to such trials, patients may drop out of its trials, patients may be harmed, or Q32 may be required to abandon the trials or its development efforts of one or more product candidates altogether, including bempikibart or ADX-097. Q32, the FDA, the EMA, or other applicable regulatory authorities, or an IRB or ethics committee, may suspend any clinical trials of bempikibart, ADX-097 or any other product candidates at any time for various reasons, including a belief that subjects or patients in such trials are being exposed to unacceptable health risks or adverse side effects. Some potential products developed in the biotechnology industry that initially showed therapeutic promise in early-stage trials have later been found to cause side effects that prevented their further development. Even if the side effects do not preclude a product candidate from obtaining or maintaining marketing approval, undesirable side effects may inhibit market acceptance of an approved product due to its tolerability versus other therapies. Treatment-emergent adverse events could also affect patient recruitment or the ability of enrolled subjects to complete its clinical trials or could result in potential product liability claims. Potential side effects associated with bempikibart, ADX-097 or any other product candidates may not be appropriately recognized or managed by the treating medical staff, as toxicities resulting from bempikibart, ADX-097 or any other product candidates may not be normally encountered in the general patient population and by medical personnel. Any of these occurrences could harm Q32’s business, financial condition, results of operations and prospects significantly.

In addition, even if Q32 successfully advances bempikibart, ADX-097 or any other product candidates through clinical trials, such trials will only include a limited number of patients and limited duration of exposure to such product candidates. As a result, Q32 cannot be assured that adverse effects of bempikibart, ADX-097 or any other product candidates will not be uncovered when a significantly larger number of patients are exposed to such product candidate after approval. Further, any clinical trials may not be sufficient to determine the effect and safety consequences of using Q32’s product candidate over a multi-year period.

If any of the foregoing events occur or if bempikibart, ADX-097 or any other product candidates prove to be unsafe, Q32’s entire pipeline could be affected, which would have a material adverse effect on its business, financial condition, results of operations and prospects.

 

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Q32 may expend its limited resources to pursue a particular product candidate, such as bempikibart or ADX-097, and fail to capitalize on candidates that may be more profitable or for which there is a greater likelihood of success.

Because Q32 has limited financial and managerial resources, Q32 intends to focus its research and development efforts on certain selected product candidates. For example, Q32 is initially focused on its most advanced product candidates, bempikibart and ADX-097. As a result, Q32 may forgo or delay pursuit of opportunities with other potential candidates that may later prove to have greater commercial potential. Q32’s resource allocation decisions may cause Q32 to fail to capitalize on viable commercial products or profitable market opportunities. Q32’s spending on current and future research and development programs for specific indications may not yield any commercially viable product candidates. If Q32 does not accurately evaluate the commercial potential or target market for a particular product candidate, Q32 may relinquish valuable rights to that candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for Q32 to retain sole development and commercialization rights to such candidate.

Even if regulatory approval is obtained, any approved products resulting from bempikibart, ADX-097 or any other product candidate may not achieve adequate market acceptance among clinicians, patients, healthcare third-party payors and others in the medical community necessary for commercial success and Q32 may not generate any future revenue from the sale or licensing of such products.

Even if regulatory approval is obtained for bempikibart, ADX-097 or any other product candidates, they may not gain market acceptance among physicians, patients, healthcare payors or the medical community. Q32 may not generate or sustain revenue from sales of the product due to factors such as whether the product can be sold at a competitive cost and whether it will otherwise be accepted in the market. There are several approved products and product candidates in later stages of development for the treatment of LN, IgAN, C3G, AAV, AD and AA. Market participants with significant influence over acceptance of new treatments, such as clinicians and third-party payors, may not adopt a drug or biologic with a target product profile such as that of bempikibart or ADX-097 for its targeted indications, and Q32 may not be able to convince the medical community and third-party payors to accept and use, or to provide favorable reimbursement for, any product candidates developed by Q32 or its existing or future collaborators. Market acceptance of bempikibart, ADX-097 or any other product candidates will depend on many factors, including factors that are not within the control of Q32.

Sales of products also depend on the willingness of clinicians to prescribe the treatment. Q32 cannot predict whether clinicians, clinicians’ organizations, hospitals, other healthcare providers, government agencies or private insurers will determine that any of its approved products are safe, therapeutically effective, cost effective or less burdensome as compared with competing treatments. If bempikibart, ADX-097 or any other product candidate is approved but does not achieve an adequate level of acceptance by such parties, Q32 may not generate or derive sufficient revenue from that product and may not become or remain profitable.

Q32 has never commercialized a product candidate and may lack the necessary expertise, personnel and resources to successfully commercialize a product candidate on its own or together with suitable collaborators.

Q32 has never commercialized a product candidate, and Q32 currently has no sales force, marketing or distribution capabilities. To achieve commercial success for a product candidate, which Q32 may license to others, Q32 may rely on the assistance and guidance of those collaborators. For a product candidate for which Q32 retains commercialization rights and marketing approval, Q32 will have to develop its own sales, marketing and supply organization or outsource these activities to a third party. Factors that may affect its ability to commercialize a product candidate, if approved, on its own include recruiting and retaining adequate numbers of effective sales and marketing personnel, developing adequate educational and marketing programs to increase public acceptance of its approved product candidate, ensuring regulatory compliance of Q32, employees and third parties under applicable healthcare laws and other unforeseen costs associated with creating an independent sales and marketing organization. Developing a sales and marketing organization will be expensive and time-consuming and could delay the launch of a product candidate upon approval. Q32 may not be able to build an

 

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effective sales and marketing organization. If Q32 is unable to build its own distribution and marketing capabilities or to find suitable partners for the commercialization of an approved product candidate, Q32 may not generate revenues from them or be able to reach or sustain profitability.

Q32 has never completed any late-stage clinical trials and Q32 may not be able to submit applications for regulatory authorizations to commence additional clinical trials on the timelines Q32 expects, and, even if Q32 is able to, the FDA, EMA or comparable foreign regulatory authorities may not permit Q32 to proceed and could also suspend/terminate the trial after it has been initiated.

Q32 is early in its development efforts and will need to successfully complete later-stage and pivotal clinical trials in order to obtain FDA, EMA or comparable foreign regulatory approval to market its product candidates. Carrying out clinical trials and the submission of a successful IND or CTA is a complicated process. As an organization, Q32 has limited experience as a company in preparing, submitting and prosecuting regulatory filings. Assuming regulatory authorities allow Q32’s proposed clinical trials for ADX-097 to proceed after review of Q32’s IND or CTA submissions, Q32 intends to initiate a renal basket program in LN, IgAN and C3G and a Phase 2 clinical trial in AAV. However, Q32 may not be able to initiate its planned clinical trials for ADX-097 in accordance with its desired timelines. For example, Q32 may experience manufacturing delays or other delays with IND-or CTA-enabling studies, including with suppliers, study sites, or third-party contractors and vendors on whom Q32 depends. Moreover, Q32 cannot be sure that submission of an IND or a CTA or submission of a trial to an IND or a CTA will result in the FDA or EMA or comparable foreign regulatory authorities allowing further clinical trials to begin, or that, once begun, issues will not arise that lead Q32 to suspend or terminate clinical trials. For example, upon submission of Q32’s IND or CTA for its planned clinical trials for ADX-097, the FDA or EMA may recommend changes to the proposed study designs, which may impact the number and size of registrational clinical trials required to be conducted in such development programs and may change Q32’s predicted timeline for clinical development. Consequently, Q32 may be unable to successfully and efficiently execute and complete necessary clinical trials in a way that leads to regulatory submission and approval of its product candidates. Additionally, even if regulatory authorities agree with the design and implementation of the clinical trials set forth in an IND or a CTA, such regulatory authorities may change their requirements in the future. The FDA, EMA or comparable foreign regulatory authorities may require the analysis of data from trials assessing different doses of the product candidate alone or in combination with other therapies to justify the selected dose prior to the initiation of large trials in a specific indication. Any delays or failure to file INDs or CTAs, initiate clinical trials, or obtain regulatory authorizations for its trials may prevent Q32 from completing its clinical trials or commercializing its products on a timely basis, if at all. Q32 is subject to similar risks related to the review and authorization of its protocols and amendments by comparable foreign regulatory authorities.

Risks Related to Q32’s Intellectual Property

Q32’s ability to protect its patents and other proprietary rights is uncertain, exposing it to the possible loss of competitive advantage.

Q32 relies upon a combination of patents, trade secret protection and confidentiality agreements to protect the intellectual property related to its product candidates and to prevent third parties from infringing on its patents and trademarks or misappropriating or violating its other intellectual property rights, thus eroding Q32’s competitive position in its market. Q32’s success depends in large part on Q32’s ability to obtain and maintain patent protection for its product candidates and their uses, components, formulations, methods of manufacturing and methods of treatment, as well as Q32’s ability to operate without infringing on or violating the proprietary rights of others. Q32 has licensed know-how and patent families that pertain to, among other things, composition of matter and certain methods of use relating to Q32’s leading product candidates bempikibart and ADX-097. Q32 seeks to protect its proprietary position by filing patent applications in the United States and abroad related to Q32’s product candidates and novel discoveries that are important to its business. Q32’s intellectual property strategy is, where appropriate, to file new patent applications on inventions, including improvements to existing

 

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products candidates and processes to improve Q32’s competitive edge or to improve business opportunities. Q32 continues to assess and refine its intellectual property strategy to ensure appropriate protection and rights are secured. However, Q32’s pending and future patent applications may not result in patents being issued. Q32 cannot assure you that issued patents will afford sufficient protection of its product candidates or their intended uses against competitors, nor can there be any assurance that the patents issued will not be infringed, designed around, invalidated by third parties, or effectively prevent others from commercializing competitive products or product candidates.

Obtaining and enforcing patents is expensive and time-consuming, and Q32 may not be able to file, prosecute, maintain, enforce or license all necessary or desirable patent applications or maintain and/or enforce patents that may issue based on Q32’s patent applications, at a reasonable cost or in a timely manner. Q32 may not be able to obtain or maintain patent applications and patents due to the subject matter claimed in such patent applications and patents being in disclosures in the public domain. It is also possible that Q32 will fail to identify patentable aspects of Q32’s research and development results before it is too late to obtain patent protection. Although Q32 enters into non-disclosure and confidentiality agreements with parties who have access to confidential or patentable aspects of Q32’s research and development output, such as its employees, corporate collaborators, outside scientific collaborators, CROs, CMOs, consultants, advisors and other third parties, any of these parties may breach these agreements and disclose such results before a patent application is filed, thereby jeopardizing Q32’sr ability to seek patent protection. Consequently, Q32 may not be able to prevent any third parties from using any of Q32’s technology that is in the public domain to compete with its product candidates.

Composition of matter patents for biotechnology and pharmaceutical product candidates often provide a strong form of intellectual property protection for those types of products, as such patents provide protection without regard to any method of use. However, Q32 cannot be certain that the claims in Q32’s pending patent applications directed to the composition of matter of its product candidates will be considered patentable by the United States Patent and Trademark Office, or USPTO, or by patent offices in foreign jurisdictions, or that the claims in any of Q32’s issued patents will be considered valid and enforceable by courts in the United States or foreign jurisdictions. Method of use patents protect the use of a product for the specified method. This type of patent does not prevent a competitor from making and marketing a product that is identical to Q32’s product candidates for an indication that is outside the scope of the patented method. Moreover, even if competitors do not actively promote their product for Q32’s targeted indications, clinicians may prescribe these products “off-label.” Although off-label prescriptions may infringe or contribute to the infringement of method of use patents, the practice is common and such infringement is difficult to prevent or prosecute.

The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. As a result, the issuance, scope, validity, enforceability and commercial value of Q32’s patent rights are highly uncertain. Q32’s current or future patent applications may not result in patents being issued which protect Q32’s technology or drug candidates or which do not effectively prevent others from commercializing competitive technologies and drug candidates. The patent examination process may require Q32 or Q32’s licensors to narrow the scope of the claims of Q32’s or Q32’s licensors’ pending and future patent applications, which may limit the scope of patent protection that may be obtained. Q32 cannot assure you that all of the potentially relevant prior art relating to Q32’s patents and patent applications has been found. If such prior art exists, it can invalidate a patent or prevent a patent application from being issued as a patent.

The issuance of a patent does not ensure that it is valid or enforceable, nor does it give Q32 the right to practice the patented invention. Issued patents may be challenged, narrowed, invalidated or circumvented and third parties may have blocking patents that could prevent Q32 from commercializing its product candidates or technologies. While Q32 endeavors to identify and circumvent third-party patents and patent applications which may block its product candidates or technologies to minimize this risk, relevant documents may be overlooked or missed, which may in turn impact Q32’s ability to commercialize the relevant asset. In addition, court decisions

 

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may introduce uncertainty in the enforceability or scope of patents owned by pharmaceutical and biotechnology companies. Thus, any of Q32’s issued patents, including patents that Q32 may rely on to protect its market for approved drugs, may be held invalid or unenforceable by a court of final jurisdiction.

A third party may also claim that Q32’s patent rights are invalid or unenforceable in a litigation. The outcome following legal assertions of invalidity and unenforceability is unpredictable. An adverse result in any legal proceeding could put one or more of Q32’s patents at risk of being invalidated or interpreted narrowly and could allow third parties to commercialize its products and compete directly with Q32, without payment to Q32, or result in its inability to manufacture or commercialize its technology, products or product candidates without infringing third-party patent rights.

Because patent applications in the U.S., Europe and many other jurisdictions are typically not published until 18 months after filing, and because publications of discoveries in scientific literature lag behind actual discoveries, Q32 cannot be certain that Q32 were the first to make the inventions claimed in its issued patents or future patent applications, or that Q32 were the first to file for protection of the inventions set forth in its patents or patent applications. As a result, Q32 may not be able to obtain or maintain protection for certain inventions. Therefore, the enforceability and scope of Q32’s future patents in the U.S., Europe and in many other jurisdictions cannot be predicted with certainty and, as a result, any future patents that Q32 owns, or license may not provide sufficient protection against competitors. Q32 may not be able to obtain or maintain patent protection from its patent applications that Q32 may file in the future, or from those Q32 may license from third parties. Moreover, even if Q32 is able to obtain patent protection, such patent protection may be of insufficient scope to achieve its business objectives.

In addition, given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such product candidates might expire before or shortly after such candidates are commercialized. The degree of future protection for Q32’s proprietary rights is uncertain. Only limited protection may be available and may not adequately protect Q32’s rights or permit Q32 to gain or keep any competitive advantage. Any failure to obtain or maintain patent protection with respect to Q32’s product candidates or their uses could adversely affect its business, financial condition, results of operations and prospects.

Q32’s rights to develop and commercialize its product candidates are and in the future may be subject to the terms and conditions of licenses granted to Q32 by others. If Q32 fails to comply with Q32’s obligations in the agreements under which Q32 licenses intellectual property rights from third parties, or these agreements are terminated, or Q32 otherwise experience disruptions to Q32’s business relationships with its licensors, Q32 could lose license rights that are important to its business.

Q32 is dependent on patents rights, know-how and proprietary technology licensed from third parties. In particular, Q32 depends substantially on its license agreement with Bristol Myers Squibb Company, or BMS, under which Q32 in-license patent rights and know-how that cover bempikibart, or BMS Agreement, and The Regents of the University of Colorado, or Colorado Agreement, under which Q32 in-license patent rights and know-how relating to ADX-097. For more information regarding the BMS Agreement and Colorado Agreement, please see the section titled “Business–Collaboration and License Agreements.” Q32 may also enter into additional agreements with third parties in the future.

Q32’s current and future license agreements may impose diligence, development and commercialization timelines, milestone payments, royalties, indemnification, insurance, or other obligations on Q32. For example, under both the BMS License Agreement and Colorado Agreement, the counterparties may terminate the agreements if Q32 fails to meet its diligence obligations, including using commercially reasonable efforts to meet diligence milestones by specified dates. If Q32 fails to comply with its obligations to its licensors or collaborators, Q32’s counterparties may have the right to terminate these agreements. Termination of these agreements or reduction or elimination of Q32’s rights under these agreements may result in Q32 having to

 

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negotiate new or reinstated agreements with less favorable terms, or cause Q32 to lose its rights under these agreements, including its rights to important intellectual property or technology that are necessary for its business.

Certain patent filings relating to Q32’s product candidates may be subject to step-in rights of certain of its licensors. Q32 may have limited control over its licensor’s activities or use or licensing of any other intellectual property that may be related to its in-licensed intellectual property. If any of Q32’s licensors or licensees having rights to file, prosecute, maintain, and defend its patent rights fail to conduct these activities for patents or patent applications covering any of Q32’s product candidates, its ability to develop and commercialize those product candidates may be adversely affected and Q32 may not be able to prevent competitors or other third parties from making, using or selling competing products. Q32 cannot be certain that such activities by its licensors have been or will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents or other intellectual property rights. Pursuant to the terms of the license agreements with Q32’s licensors, such licensors may have the right to control enforcement of its licensed patents or defense of any claims asserting the invalidity of such patents and, even if Q32 are permitted to pursue such enforcement or defense, Q32 cannot ensure the cooperation of its licensors or, in some cases, other necessary parties, such as any co-owners of patents or other intellectual property from which Q32 has not yet obtained a license. Q32 cannot be certain that its licensors, and in some cases, their co-owners, will allocate sufficient resources or prioritize their or Q32’s enforcement of such patents or defense of such claims to protect its interests in the licensed patents. Even if Q32 is not a party to these legal actions, an adverse outcome could harm its business because it might prevent Q32 from continuing to license intellectual property that Q32 may need to operate its business. In addition, even when Q32 has the right to control patent prosecution of licensed patents and patent applications, enforcement of licensed patents, or defense of claims asserting the invalidity of those patents, Q32 may still be adversely affected or prejudiced by actions or inactions of its licensors and their counsel that took place prior to or after its assuming control.

Q32’s current or future license agreements may not provide exclusive or sufficient rights to use such intellectual property and technology in all relevant fields of use and in all territories in which Q32 may wish to develop or commercialize its product candidates in the future. Some licenses granted to Q32 may be subject to certain preexisting rights held by the licensors or certain third parties. As a result, Q32 may not be able to prevent third parties from developing and commercializing competitive products in certain territories or fields.

In the event that Q32’s third party licensors determine that, in spite of its efforts, Q32 have materially breached a license agreement or have failed to meet certain obligations thereunder, it may elect to terminate the license agreement or, in some cases, one or more license(s) under the applicable license agreement. Such termination could result in Q32 losing the ability to develop and commercialize product candidates and technology covered by the licensed intellectual property. In the event of such termination of a third-party in-license, or if the underlying patent rights under a third-party in-license fail to provide the intended exclusivity, third parties may be able to seek regulatory approval of, and to market, products identical to Q32’s. Moreover, Q32’s licensors may own or control intellectual property that has not been licensed to Q32 and, as a result, Q32 may be subject to claims, regardless of their merit, that Q32 is infringing or otherwise violating the licensor’s rights. Any of these events could have a material adverse effect on its competitive position, business, financial conditions, results of operations and prospects.

If Q32’s current or future license agreements are terminated, or if the underlying patent rights fail to provide the intended exclusivity, competitors or other third parties may be able to seek regulatory approval of, and to market, products identical to Q32’s and Q32 may be required to cease its development and commercialization of its product candidates. Any of the foregoing could have a material adverse effect on Q32’s competitive position, business, financial condition, results of operations and prospects. Disputes may arise regarding intellectual property subject to a licensing agreement, including:

 

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the scope of rights granted under the license agreement and other interpretation-related issues;

 

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the extent to which Q32’s technology and processes infringe, misappropriate or violate intellectual property of the licensor that is not subject to the licensing agreement;

 

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the sublicensing of patent rights to third parties under Q32’s license agreements or collaborative development relationships;

 

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Q32’s diligence obligations under the license agreement with respect to the use of the licensed technology in relation to its development and commercialization of its product candidates and what activities satisfy those diligence obligations;

 

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the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by Q32’s licensor and Q32 and Q32’s partners; or

 

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the priority of invention of patented technology.

Q32’s current or future license agreements may be subject to certain rights retained by third parties.

Q32’s current or future licensors may retain certain rights under the relevant agreements with Q32, including the right to use the underlying product candidates for academic and research use, to publish general scientific findings from research related to the product candidates, to make customary scientific and scholarly disclosures of information relating to the product candidates, or to develop or commercialize the licensed product candidates in certain regions. In addition, the United States federal government retains certain rights in inventions produced with its financial assistance under the Patent and Trademark Law Amendments Act, or Bayh-Dole Act, including a “nonexclusive, nontransferable, irrevocable, paid-up license” for its own benefit. Q32 may at times choose to collaborate with academic institutions to accelerate its preclinical research or development that are subject to the Bayh-Dole Act. The Bayh-Dole Act also provides federal agencies with “march-in rights.” March-in rights allow the government, in specified circumstances, to require the contractor or successors in title to the patent to grant a “nonexclusive, partially exclusive, or exclusive license” to a “responsible applicant or applicants.” If the patent owner refuses to do so, the government may grant the license itself.

In addition, the United States government requires that any products embodying the subject invention or produced through the use of the subject invention be manufactured substantially in the United States. The manufacturing preference requirement can be waived if the owner of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible. This preference for United States manufacturers may limit our ability to contract with non-United States product manufacturers for products covered by such intellectual property. Any exercise by the government of any of the foregoing rights could harm Q32’s competitive position, business, financial condition, results of operations and prospects.

Q32 cannot ensure that patent rights relating to inventions described and claimed in its current or future licensors pending patent applications will issue or that patents based on Q32 or any of Q32’s current future licensors patent applications will not be challenged and rendered invalid and/or unenforceable.

The patent application process is subject to numerous risks and uncertainties, and there can be no assurance that Q32 or any potential future licensors or collaborators will be successful in protecting its product candidates by obtaining and defending patents. Q32 have several pending United States and foreign patent applications in its portfolio. Q32 cannot predict:

 

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if and when patents may issue based on Q32’s patent applications;

 

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the scope of protection of any patent issuing based on Q32’s patent applications;

 

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whether the claims of any patent issuing based on Q32’s patent applications will provide protection against competitors;

 

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whether or not third parties will find ways to invalidate or circumvent Q32’s patent rights;

 

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whether or not others will obtain patents claiming aspects similar to those covered by Q32’s patents and patent applications;

 

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whether Q32 will need to initiate litigation or administrative proceedings to enforce and/or defend Q32’s patent rights which will be costly whether Q32 win or lose; and

 

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whether the patent applications that Q32 own will result in issued patents with claims that cover its product candidates or uses thereof in the United States or in other foreign countries.

Q32 cannot be certain that the claims in its or any future licensors’ pending patent applications directed to its product candidates will be considered patentable by the USPTO or by patent offices in foreign countries. There can be no assurance that any such patent applications will issue as granted patents. One aspect of the determination of patentability of Q32’s or any future licensors’ inventions depends on the scope and content of the “prior art,” information that was or is deemed available to a person of skill in the relevant art prior to the priority date of the claimed invention. There may be prior art of which Q32 is not aware that may affect the patentability of its or any future licensors’ patent claims or, if issued, affect the validity or enforceability of a patent claim. Even if the patents do issue based on Q32’s or any future licensors’ patent applications, third parties may challenge the validity, enforceability or scope thereof, which may result in such patents being narrowed, invalidated or held unenforceable. Furthermore, even if they are unchallenged, patents in Q32’s or any future licensors’ portfolio may not adequately exclude third parties from practicing relevant technology or prevent others from designing around its claims. If the breadth or strength of Q32’s intellectual property position with respect to its product candidates is threatened, it could dissuade companies from collaborating with Q32 to develop and threaten its ability to commercialize its product candidates. In the event of litigation or administrative proceedings, Q32 cannot be certain that the claims in any of its issued patents will be considered valid by courts in the United States or foreign countries.

Q32 enjoys only limited geographical protection with respect to its patents and licensed patents and may not be able to protect Q32’s intellectual property rights throughout the world.

Q32 may not be able to protect its intellectual property rights throughout the world and the legal systems in certain countries may not favor enforcement or protection of patents, trade secrets and other intellectual property. Patents are of national or regional effect, and although Q32 currently has issued patents and pending applications in the United States, filing, prosecuting and defending patents on all of Q32’s research programs and product candidates in all countries throughout the world would be prohibitively expensive. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States, even in jurisdictions where Q32 does pursue patent protection. Consequently, Q32 may not be able to prevent third parties from practicing Q32’s or any of its licensors’ inventions in all countries outside the United States, even in jurisdictions where Q32 or any of Q32’s current or future licensors do pursue patent protection, or from selling or importing products made using Q32’s or any of Q32’s licensors’ inventions in and into the United States or other jurisdictions. Competitors may use Q32’s or any of its licensors’ technologies in jurisdictions where Q32 has not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where Q32 or any future licensors have patent protection, but enforcement is not as strong as that in the United States. These competitor products may compete with Q32’s product candidates, and Q32’s or any of its licensors’ patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Various companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of many countries do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biotechnology and pharmaceutical products, which could make it difficult for Q32 to stop the infringement of Q32’s or Q32’s licensors’ patents or marketing of competing products in violation of its proprietary rights.

 

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In addition, some countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. Many countries also limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. If Q32 or any of Q32’s licensors is forced to grant a license to third parties with respect to any patents relevant to its business, Q32’s competitive position may be impaired, and its business and financial condition may be adversely affected. Accordingly, Q32’s efforts to enforce its intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that Q32 develops or licenses.

Certain countries outside the United States have laws that may impact a patent owner’s right to claim priority or require a patent applicant to obtain a foreign filing license or first file patent applications in a foreign jurisdiction to the extent that foreign nationals are involved in the development of the claimed subject matter of the resulting patent. Q32’s pending and future patent applications may not result in patents being issued that comply with the law of each foreign jurisdiction. Pending applications and issued patents may be challenged in various jurisdictions for failure to comply with local foreign laws, which could result in the rejection of pending applications or invalidation of issued patents. Further, the standards applied by the USPTO and foreign patent offices in granting patents are not always applied uniformly or predictably. As such, Q32 does not know the degree of future protection that Q32 will have on its product candidates. While Q32 will endeavor to try to protect its product candidates with intellectual property rights, such as patents, as appropriate, the process of obtaining patents is time consuming, expensive and unpredictable.

In addition, geo-political actions in the United States and in foreign countries could increase the uncertainties and costs surrounding the prosecution or maintenance of Q32’s patent applications or those of any current or future licensors and the maintenance, enforcement or defense of Q32’s issued patents or those of any current or future licensors. For example, the United States and foreign government actions related to Russia’s conflict in Ukraine may limit or prevent filing, prosecution, and maintenance of patent applications in Russia. Government actions may also prevent maintenance of issued patents in Russia. These actions could result in abandonment or lapse of Q32’s patents or patent applications, resulting in partial or complete loss of patent rights in Russia. If such an event were to occur, it could have a material adverse effect on its business. In addition, a decree was adopted by the Russian government in March 2022, allowing Russian companies and individuals to exploit inventions owned by patentees from the United States without consent or compensation. Consequently, Q32 would not be able to prevent third parties from practicing its inventions in Russia or from selling or importing products made using Q32’s inventions in and into Russia. Accordingly, Q32’s competitive position may be impaired, and its business, financial condition, results of operations and prospects may be adversely affected.

Obtaining and maintaining Q32’s patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and its patent protection could be reduced or eliminated if Q32 fails to comply with these requirements.

Periodic maintenance and annuity fees on any issued patent are due to be paid to the U.S. Patent and Trademark Office, or USPTO, and foreign patent agencies over the lifetime of a patent. In addition, the USPTO and other foreign patent agencies require compliance with a number of procedural, documentary, fee payment, and other similar provisions during the patent application process. While an inadvertent failure to make payment of such fees or to comply with such provisions can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which such non-compliance will result in the abandonment or lapse of the patent or patent application, and the partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of a patent or patent application include failure to respond to official actions within prescribed time limits, and non-payment of fees and failure to properly legalize and submit formal documents within prescribed time limits. If Q32 or Q32’s licensors fail to maintain the patents and patent applications covering its drug candidates or if Q32 or Q32’s

 

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licensors otherwise allow its patents or patent applications to be abandoned or lapse, Q32’s competitors might be able to enter the market, which would hurt Q32’s competitive position and could impair its ability to successfully commercialize its drug candidates in any indication for which they are approved.

Issued patents covering one or more of Q32’s product candidates could be found invalid or unenforceable.

Any issued patents that Q32 may license or own covering its product candidates could be narrowed or found invalid or unenforceable if challenged in court or before administrative bodies in the U.S. or abroad, including the USPTO. Patent terms, including any extensions or adjustments that may or may not be available to Q32, may be inadequate to protect its competitive position with respect to Q32’s product candidates for an adequate amount of time, and Q32 may be subject to claims challenging the inventorship, validity, enforceability of its patents and/or other intellectual property. Further, if Q32 encounters delays in its clinical trials or delays in obtaining regulatory approval, the period of time during which Q32 could market its product candidates under patent protection would be reduced. Thus, the patents that Q32 owns and licenses may not afford Q32 any meaningful competitive advantage.

Moreover, Q32 or Q32’s licensors may be subject to a third-party pre-issuance submission of prior art to the USPTO or the European Patent Office or become involved in opposition, derivation, revocation, reexamination, inter partes review, post-grant review or interference proceedings challenging Q32’s patent rights or the patent rights of others. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, Q32’s patent rights, allow third parties to commercialize its product candidates and compete directly with Q32, without payment to Q32, or result in its inability to manufacture or commercialize drugs without infringing third-party patent rights. If the breadth or strength of protection provided by Q32’s patents and patent applications is threatened, regardless of the outcome, it could dissuade companies from collaborating with Q32 to license, develop or commercialize its product candidates.

Patent terms may be inadequate to protect Q32’s competitive position with respect to its product candidates for an adequate amount of time.

Patents have a limited lifespan. In the U.S., if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Once patents covering Q32’s product candidates have expired, Q32 may be open to competition from competitive products, including generics or biosimilars. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, Q32’s owned and licensed patent portfolio may not provide Q32 with sufficient rights to exclude others from commercializing products similar or identical to Q32’s.

If Q32 does not obtain patent term extension in the U.S. under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the term of Q32’s marketing exclusivity for its product candidates, if approved, its business may be materially harmed.

In the U.S., the patent term of a patent that covers an FDA-approved drug may be eligible for limited patent term extension, which permits patent term restoration as compensation for the patent term lost during the FDA regulatory review process. The Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act, permits a patent term extension of up to five years beyond the expiration of the patent. The length of the patent term extension is related to the length of time the drug is under regulatory review. However, a patent extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent applicable to an approved drug may be extended and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended. Similar provisions are available in Europe and certain other non-U.S. jurisdictions to extend the term of a patent that covers an approved drug. While, in the future, if and when Q32’s product candidates receive FDA approval, Q32

 

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expects to apply for patent term extension on patents covering such product candidates, there is no guarantee that the applicable authorities will agree with Q32’s assessment of whether such extension should be granted, and even if granted, the length of such extension. Q32 may not be granted patent term extension either in the U.S. or in any foreign country because of, for example, failing to exercise due diligence during the testing phase or regulatory review process, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable requirements. Moreover, the term of extension, as well as the scope of patent protection during any such extension, afforded by the governmental authority could be less than Q32 requests. If Q32 is unable to obtain any patent term extension or the term of any such extension is less than Q32 requests, Q32’s competitors may obtain approval of competing products following the expiration of Q32’s patent rights, and Q32’s business, financial condition, results of operations and prospects could be materially harmed.

Also, there are detailed rules and requirements regarding the patents that may be submitted to the FDA for listing in the Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations, or the Purple Book, a searchable, online database that contains information about biological products, including biosimilar and interchangeable biological products, licensed (approved) by the FDA under the Public Health Service Act). Q32 may be unable to obtain patents covering its product candidates that contain one or more claims that satisfy the requirements for listing in the Purple Book. Even if Q32 submit a patent for listing in the Purple Book, the FDA may decline to list the patent, or a manufacturer of generic drugs may challenge the listing. If any of Q32’s product candidates are approved and patents covering such product candidates not listed in the Purple Book, a manufacturer of generic drugs would not have to provide advance notice to Q32 of any abbreviated new drug application filed with the FDA to obtain permission to sell a generic version of such product candidates.

Changes to patent laws in the U.S. and other jurisdictions could diminish the value of patents in general, thereby impairing Q32’s ability to protect its intellectual property.

Changes in either the patent laws or interpretation of patent laws in the U.S., including patent reform legislation such as the Leahy-Smith America Invents Act, or the Leahy-Smith Act, could increase the uncertainties and costs surrounding the prosecution of Q32’s future owned and in-licensed patent applications and the maintenance, enforcement or defense of its owned and in-licensed issued patents. The Leahy-Smith Act includes a number of significant changes to U.S. patent law. These changes include provisions that affect the way patent applications are prosecuted, redefine prior art, provide more efficient and cost-effective avenues for competitors to challenge the validity of patents, and enable third-party submission of prior art to the USPTO during patent prosecution and additional procedures to challenge the validity of a patent at USPTO-administered post-grant proceedings, including post-grant review, inter partes review, and derivation proceedings. Assuming that other requirements for patentability are met, prior to March 2013, in the U.S., the first to invent the claimed invention was entitled to the patent, while outside the U.S., the first to file a patent application was entitled to the patent. After March 2013, under the Leahy-Smith Act, the U.S. transitioned to a first-to-file system in which, assuming that the other statutory requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. As such, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of Q32’s patent applications and the enforcement or defense of Q32’s issued patents, all of which could have a material adverse effect on Q32’s business, financial condition, results of operations and prospects.

In addition, the patent positions of companies in the development and commercialization of biologics and pharmaceuticals are particularly uncertain. Recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and altered the rights of patent owners in certain situations. This combination of events has created uncertainty with respect to the validity and enforceability of patents once obtained. Depending on future legislation by the U.S. Congress, decisions by the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could have a material

 

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adverse effect on Q32’s patent rights and its ability to protect, defend and enforce its patent rights in the future. For example, in the case Amgen v. Sanofi, the Supreme Court held broad functional antibody claims invalid for lack of enablement. Similarly, in the case Juno v. Kite, the Federal Circuit held genus claims directed to CAR-T cells invalid for lack of written description for failing to provide disclosure commensurate with the scope of the claims. While Q32 does not believe that any of the patents licensed or owned by Q32 will be found invalid based on these decisions, Q32 cannot predict how future decisions by the courts, the U.S. Congress or the USPTO may impact the value of its patents. Similarly, changes in the patent laws of other jurisdictions could adversely affect Q32’s ability to obtain and effectively enforce its patent rights, which would have a material adverse effect on Q32’s business and financial condition.

Moreover, in 2012, the European Union Patent Package, or EU Patent Package, regulations were passed with the goal of providing a single pan-European Unitary Patent, or UP, covering all participating European Union member states, and a new European Unified Patent Court, UPC, for litigation involving European patents including all UPs. The EU Patent Package was implemented on June 1, 2023. As a result, all European patents, including those issued prior to ratification of the EU Patent Package, now by default automatically fall under the jurisdiction of the UPC. It is uncertain how the UPC will impact granted European patents in the biotechnology and pharmaceutical industries. Q32’s European patent applications, if issued, could be challenged in the UPC if not opted out. During the first seven years of the UPC’s existence, the UPC legislation allows a patent owner to opt its European patents out of the jurisdiction of the UPC. Q32 may decide to opt out its future European patents from the UPC, but doing so may preclude Q32 from realizing the benefits of the UPC. Moreover, if Q32 does not meet all of the formalities and requirements for opt-out under the UPC before the prescribed deadlines, Q32’s future European patents could remain under the jurisdiction of the UPC. The UPC will provide Q32’s competitors with a new forum to centrally revoke its European patents that have not been opted out, and allow for the possibility of a competitor to obtain pan-European injunction. Such a loss of patent protection could have a material adverse impact on Q32’s business and its ability to commercialize its technology and product candidates and, resultantly, on its business, financial condition, prospects and results of operations.

Q32 may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect its ability to develop and market its product candidates, if approved.

Q32 cannot guarantee that any of its patent searches or analyses, including the identification of relevant third party patents, the scope of said patent claims or the expiration of relevant patents, are complete, accurate or thorough, nor can Q32 be certain that Q32 have identified each and every third-party patent and pending application in the U.S. and abroad that is relevant to or necessary for the commercialization of its product candidates, if approved, in any jurisdiction. The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history. Q32’s interpretation of the relevance or the scope of a patent or a pending application may be incorrect. Q32’s determination of the expiration date of any patent in the U.S. or abroad that Q32 considers relevant may be incorrect. Q32’s failure to identify and correctly interpret relevant patents may negatively impact its ability to develop and market its product candidates.

In addition, because some patent applications in the U.S. may be maintained in secrecy until the patents are issued, patent applications in the U.S. and many foreign jurisdictions are typically not published until 18 months after filing, and publications in the scientific literature often lag behind actual discoveries, Q32 cannot be certain that others have not filed patent applications for technology covered by its issued patents or Q32’s pending applications, or that Q32 were the first to invent the technology. Q32’s competitors may have filed, and may in the future file, patent applications covering its product candidates or technology similar to Q32’s. Any such patent application may have priority over its patent applications or patents, which could require Q32 to obtain rights to issued patents covering such product candidates or technologies.

 

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Q32 may be subject to claims challenging the inventorship of its patents and other intellectual property.

Q32 may be subject to claims that former employees, collaborators or other third parties have an interest in its or any future licensors’ patents or other intellectual property as an inventor or co-inventor. The failure to name the proper inventors on a patent application can result in the patents issuing thereon being unenforceable. Inventorship disputes may arise from conflicting views regarding the contributions of different individuals named as inventors, the effects of foreign laws where foreign nationals are involved in the development of the subject matter of the patent, conflicting obligations of third parties involved in developing Q32’s product candidates or as a result of questions regarding co-ownership of potential joint inventions. Litigation may be necessary to resolve these and other claims challenging inventorship or ownership. Alternatively, or additionally, Q32 may enter into agreements to clarify the scope of its rights in such intellectual property. If Q32 fails in defending any such claims, in addition to paying monetary damages, Q32 may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could adversely affect its business. Even if Q32 is successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

Q32’s current or future licensors may have relied on third-party consultants or collaborators or on funds from third parties, such as the United States government, such that these licensors are not the sole and exclusive owners of the patents Q32 in-licensed. If other third parties have ownership rights or other rights to Q32’s in-licensed patents, they may be able to license such patents to its competitors, and Q32’s competitors could market competing products and technology. This could adversely affect Q32’s competitive position, business, financial condition, results of operations, and prospects.

In addition, while it is Q32’s policy to require its employees, consultants, and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to Q32, it may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that Q32 regard as its own. The assignment of intellectual property rights may not be self-executing, or the assignment agreements may be breached or challenged, and Q32 may be forced to bring claims against third parties, or defend claims that they may bring against Q32, to determine the ownership of what Q32 regards as its intellectual property. Such claims could adversely affect Q32’s business, financial condition, results of operations, and prospects.

Q32 may be subject to claims asserting that its employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what Q32 regards as its own intellectual property.

Certain of Q32’s employees, consultants or advisors have in the past and may in the future be employed at universities or other biotechnology or pharmaceutical companies, including Q32’s competitors or potential competitors. Although Q32 tries to ensure that its employees, consultants and advisors do not use the proprietary information or know-how of others in their work for Q32, it may be subject to claims that these individuals or Q32 has used or disclosed intellectual property, including trade secrets or other proprietary information, of any such individual’s current or former employer. Litigation may be necessary to defend against these claims. If Q32 fails in defending any such claims, in addition to paying monetary damages, Q32 may lose valuable intellectual property rights. An inability to incorporate such technologies or features would harm Q32’s business and may prevent Q32 from successfully commercializing its technologies or product candidates. In addition, Q32 may lose personnel as a result of such claims and any such litigation, or the threat thereof, may adversely affect Q32’s ability to hire employees or contract with independent contractors. A loss of key personnel or their work product could hamper or prevent its ability to commercialize its technologies, or product candidates, which could adversely affect Q32’s business, financial condition, results of operations and prospects. Even if Q32 is successful in defending against such claims, litigation could result in substantial costs and be a distraction to management.

In addition, Q32 may in the future be subject to claims by former employees, consultants or other third parties asserting an ownership right in its patents or patent applications. An adverse determination in any such

 

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submission or proceeding may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit its ability to stop others from using or commercializing similar technology and therapeutics, without payment to Q32, or could limit the duration of the patent protection covering its technologies and product candidates. Such challenges may also result in Q32’s inability to develop, manufacture or commercialize its technologies and product candidates without infringing third-party patent rights. In addition, if the breadth or strength of protection provided by Q32’s patents and patent applications is threatened, it could dissuade companies from collaborating with Q32 to license, develop or commercialize current or future technologies and product candidates. Any of the foregoing could adversely affect Q32’s business, financial condition, results of operations and prospects.

Q32 may be involved in lawsuits to protect or enforce its patents or other intellectual property, which could be expensive, time-consuming and unsuccessful.

Competitors or other third parties may infringe Q32’s patents or trademarks or misappropriate or violate its other intellectual property rights. To counter infringement, misappropriation or unauthorized use, Q32 or any future licensors may be required to file infringement or misappropriation claims, which can be expensive and time consuming and divert the time and attention of Q32’s management and scientific personnel. Q32 or any future licensors’ pending patent applications cannot be enforced against third parties practicing the technology claimed in such applications unless and until a patent issues from such applications. Any claims Q32 asserts against perceived infringers could provoke these parties to assert counterclaims against Q32 alleging that Q32 infringed their patents, in addition to counterclaims asserting that Q32’s patents or any future licensors’ patents are invalid or unenforceable, or both. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, non-enablement, insufficient written description, obviousness-type double patenting, or failure to claim patent-eligible subject matter. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO or made a misleading statement during prosecution. The outcome following legal assertions of invalidity and unenforceability is unpredictable. In any patent infringement proceeding, there is a risk that a court will decide that a patent of Q32’s or any future licensors is invalid or unenforceable, in whole or in part, and that Q32 does not have the right to stop the other party from using the invention at issue. There is also a risk that, even if the validity of such patents is upheld, the court will construe the patent’s claims narrowly or decide that Q32 does not have the right to stop the other party from using the invention at issue on the grounds that Q32’s or any future licensors’ patent claims do not cover the invention, or decide that the other party’s use of Q32’s or any future licensors’ patented technology falls under the safe harbor to patent infringement under 35 U.S.C. §271(e)(1). An adverse outcome in a litigation or proceeding involving Q32’s or any future licensors’ patents could limit its ability to assert Q32’s or any future licensors’ patents against those parties or other competitors and may curtail or preclude its ability to exclude third parties from making and selling similar or competitive products. Any of these occurrences could adversely affect Q32’s competitive position, and its business, financial condition, results of operations and prospects. Similarly, if Q32 asserts trademark infringement claims, a court may determine that the marks Q32 has asserted are invalid or unenforceable, or that the party against whom Q32 has asserted trademark infringement has superior rights to the marks in question. In this case, Q32 could ultimately be forced to cease use of such trademarks.

Even if Q32 establishes infringement, the court may decide not to grant an injunction against further infringing activity and instead award only monetary damages, which may or may not be an adequate remedy. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of Q32’s confidential information could be compromised by disclosure during litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could adversely affect the price of shares of its common stock. Moreover, Q32 cannot assure you that it will have sufficient financial or other resources to file and pursue such infringement claims, which typically last for years

 

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before they are concluded. Even if Q32 ultimately prevails in such claims, the monetary cost of such litigation and the diversion of the attention of its management and scientific personnel could outweigh any benefit Q32 receives as a result of the proceedings.

Q32 may become involved in third-party claims of intellectual property infringement, misappropriation or violation, which may prevent or delay Q32’s product discovery and development efforts.

Q32’s commercial success depends in part on its avoiding infringement of the patents or trademarks and misappropriation or violation of other proprietary rights of third parties. There is a substantial amount of litigation involving the infringement of patents or trademarks and misappropriation or violation of other intellectual property rights in the biotechnology and pharmaceutical industries. Q32 may be exposed to, or threatened with, future litigation by third parties having patent, trademark or other intellectual property rights and who allege that its product candidates, uses and/or other proprietary technologies infringe their patents or trademarks or misappropriate or violate their other intellectual property rights. Numerous United States and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which Q32 is developing its product candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk that Q32’s product candidates may give rise to claims of infringement of the patent rights of others increases. Moreover, it is not always clear to industry participants, including Q32, which patents exist which may be found to cover various types of drugs, products or their methods of use or manufacture. Thus, because of the large number of patents issued and patent applications currently pending in its fields, there may be a risk that third parties may allege they have patent rights which are infringed by its product candidates, technologies or methods.

If a third party alleges that Q32 infringed its patents or trademarks or misappropriate or violate its other intellectual property rights, Q32 may face a number of issues, including, but not limited to:

 

  •  

patent and trademark infringement and other intellectual property misappropriation or violation which, regardless of merit, may be expensive and time-consuming to litigate and may divert Q32’s management’s attention from its core business;

 

  •  

substantial damages for infringement, misappropriation or violation, which Q32 may have to pay if a court decides that the product candidate or technology at issue infringes on, misappropriates or violates the third-party’s rights;

 

  •  

an injunction prohibiting Q32 from manufacturing, marketing or selling its product candidates, or from using Q32’s proprietary technologies, unless the third party agrees to license its patent rights to Q32;

 

  •  

even if a license is available from a third party, Q32 may have to pay substantial royalties, upfront fees and other amounts, and/or grant cross-licenses to intellectual property rights protecting its product candidates or processes; and

 

  •  

Q32 may be forced to try to redesign its product candidates or processes so they do not infringe third-party patents or trademarks or misappropriate or violate other third party intellectual property rights, an undertaking which may not be possible or which may require substantial monetary expenditures and time.

Some of Q32’s competitors may be able to sustain the costs of complex patent litigation more effectively than Q32 can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on Q32’s ability to raise the funds necessary to continue its operations or could otherwise have a material adverse effect on its business, results of operations, financial condition and prospects.

Third parties may assert that Q32 is employing their proprietary technology without authorization. Generally, conducting preclinical and clinical trials and other development activities in the United States is not

 

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considered an act of infringement. While Q32 may believe that patent claims or other intellectual property rights of a third party would not have a materially adverse effect on the commercialization of its product candidates, Q32 may be incorrect in this belief, or Q32 may not be able to prove it in litigation. In this regard, patents issued in the United States by law enjoy a presumption of validity that can be rebutted only with evidence that is “clear and convincing,” a heightened standard of proof. There may be issued third-party patents of which Q32 is currently unaware with claims to compositions, formulations, methods of manufacture or methods for treatment related to the use or manufacture of Q32’s product candidates. Patent applications can take many years to issue. There may be currently pending patent applications which may later result in issued patents that may be infringed by Q32’s product candidates. Moreover, Q32 may fail to identify relevant patents or incorrectly conclude that a patent is invalid, not enforceable, exhausted, or not infringed by its activities. If any third-party patents, held now or obtained in the future by a third party, were found by a court of competent jurisdiction to cover the manufacturing process of Q32’s product candidates, the holders of any such patents may be able to block Q32’s ability to commercialize the product candidate unless Q32 obtains a license under the applicable patents, or until such patents expire or they are finally determined to be held invalid or unenforceable. Similarly, if any third-party patent were held by a court of competent jurisdiction to cover any aspect of Q32’s formulations, any combination therapies or patient selection methods, the holders of any such patent may be able to block Q32’s ability to develop and commercialize the product candidate unless Q32 obtains a license or until such patent expires or is finally determined to be held invalid or unenforceable. In either case, such a license may not be available on commercially reasonable terms or at all. If Q32 is unable to obtain a necessary license to a third-party patent on commercially reasonable terms, or at all, Q32’s ability to commercialize its product candidates may be impaired or delayed, which could in turn significantly harm its business. Even if Q32 obtains a license, it may be non-exclusive, thereby giving its competitors access to the same technologies licensed to Q32. In addition, if the breadth or strength of protection provided by Q32’s patents and patent applications is threatened, it could dissuade companies from collaborating with Q32 to license, develop or commercialize current or future product candidates.

Parties making claims against Q32 may seek and obtain injunctive or other equitable relief, which could effectively block its ability to further develop and commercialize Q32’s product candidates. Defense of these claims, regardless of their merit, could involve substantial litigation expense and would be a substantial diversion of employee resources from its business. In the event of a successful claim of infringement against Q32, it may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign Q32’s infringing products, which may be impossible or require substantial time and monetary expenditure. Q32 cannot predict whether any such license would be available at all or whether it would be available on commercially reasonable terms. Furthermore, even in the absence of litigation, Q32 may need or may choose to obtain licenses from third parties to advance its research or allow commercialization of Q32’s product candidates. Q32 may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. In that event, Q32 would be unable to further develop and commercialize its product candidates, which could harm its business significantly.

If Q32 is unable to protect the confidentiality of its trade secrets, Q32’s business and competitive position would be harmed.

In addition to the protection afforded by patents, Q32 relies on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable or which Q32 elects not to patent, processes for which patents are difficult to enforce and any other elements of Q32’s discovery and development processes that involve proprietary know-how, information or technology that is not covered by patents. Q32 may also rely on trade secret protection as temporary protection for concepts that may be included in a future patent filing. However, trade secret protection will not protect Q32 from innovations that a competitor develops independently of its proprietary know-how. If a competitor independently develops a technology that Q32 protects as a trade secret and files a patent application on that technology, then Q32 may not be able to patent that technology in the future, may require a license from the competitor to use its own know-how, and if the license is not available on

commercially viable terms, then Q32 may not be able to launch its product candidate. Additionally, trade secrets

 

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can be difficult to protect and some courts inside and outside the United States are less willing or unwilling to protect trade secrets. The laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws within the United States. Q32 may need to share its trade secrets and proprietary know-how with current or future partners, collaborators, contractors and others located in countries at heightened risk of theft of trade secrets, including through direct intrusion by private parties or foreign actors, and those affiliated with or controlled by state actors. As a result, Q32 may encounter significant problems in protecting and defending its intellectual property both in the United States and abroad. If Q32 is unable to prevent unauthorized material disclosure of its intellectual property to third parties, Q32 will not be able to establish or maintain a competitive advantage in its market, which could materially adversely affect its business, operating results and financial condition.

Monitoring unauthorized disclosure and detection of unauthorized disclosure is difficult, and Q32 does not know whether the steps Q32 has taken to prevent such disclosure are, or will be, adequate. If Q32 were to enforce a claim that a third party had illegally obtained and was using its trade secrets, it would be expensive and time-consuming, and the outcome would be unpredictable. These lawsuits may consume Q32’s time and other resources even if Q32 is successful. For example, significant elements of Q32’s products, including confidential aspects of sample preparation, methods of manufacturing, cell culturing conditions, computational-biological algorithms, and related processes and software, are based on unpatented trade secrets. Although Q32 requires all of its employees to assign their inventions to Q32, and require all of its employees, consultants, advisors and any third parties who have access to its proprietary know-how, information or technology to enter into confidentiality agreements, Q32 cannot be certain that its trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to its trade secrets. If Q32’s trade secrets are not adequately protected, its business, financial condition, results of operations and prospects could be adversely affected.

Q32 may be subject to damages resulting from claims that Q32 or its employees have wrongfully used or disclosed confidential information of Q32’s competitors or are in breach of non-competition or non-solicitation agreements with its competitors.

As is common in the biotechnology and pharmaceutical industries, Q32 employs individuals and engage the services of consultants who previously or concurrently worked for other biotechnology or pharmaceutical companies, including Q32’s competitors or potential competitors. Although no claims against Q32 are currently pending, Q32 may be subject to claims that these employees or Q32 has inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers, or that its consultants have used or disclosed trade secrets or other proprietary information of their former or current clients. Litigation may be necessary to defend against these claims. If Q32 fails in defending any such claims, in addition to paying monetary damages, Q32 may lose valuable intellectual property rights or personnel. Even if Q32 is successful in defending against such claims, litigation or other legal proceedings relating to intellectual property claims may cause Q32 to incur significant expenses and could distract its technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments, and, if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of Q32’s common stock. This type of litigation or proceeding could substantially increase Q32’s operating losses and reduce Q32’s resources available for development activities. Q32 may not have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some of Q32’s competitors may be able to sustain the costs of such litigation or proceedings more effectively than Q32 can. Uncertainties resulting from the initiation and continuation of patent litigation or other intellectual property related proceedings could adversely affect Q32’s ability to compete in the marketplace.

 

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Q32 may not be able to effectively secure first-tier technologies when competing against other companies or investors.

Q32’s future success may require that it acquire patent rights and know-how to new or complementary technologies. However, Q32 competes with a substantial number of other companies that may also compete for technologies Q32 desires. In addition, many venture capital firms and other institutional investors, as well as other biotechnology companies, invest in companies seeking to commercialize various types of emerging technologies. Many of these companies have greater financial, scientific and commercial resources than Q32. Therefore, Q32 may not be able to secure the technologies Q32 desires. Furthermore, should any commercial undertaking by Q32 prove to be successful, there can be no assurance competitors with greater financial resources will not offer competitive products and/or technologies.

If Q32’s trademarks and trade names are not adequately protected, then Q32 may not be able to build name recognition in its markets of interest and its business may be adversely affected.

Q32’s future registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. During trademark registration proceedings, Q32 may receive rejections of its applications by the USPTO or in other foreign jurisdictions. Although Q32 is given an opportunity to respond to such rejections, Q32 may be unable to overcome them. In addition, in the USPTO and in comparable agencies in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against its trademarks, which may not survive such proceedings. Moreover, any name Q32 has proposed to use with its product candidate in the United States must be approved by the FDA, regardless of whether Q32 has registered it, or applied to register it, as a trademark. Similar requirements exist in Europe. The FDA typically conducts a review of proposed product names, including an evaluation of potential for confusion with other product names. If the FDA or an equivalent administrative body in a foreign jurisdiction objects to any of Q32’s proposed proprietary product names, Q32 may be required to expend significant additional resources in an effort to identify a suitable substitute name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the FDA. Furthermore, in many countries, owning and maintaining a trademark registration may not provide an adequate defense against a subsequent infringement claim asserted by the owner of a senior trademark.

Q32 may not be able to protect its rights to these trademarks and trade names, which Q32 needs to build name recognition among potential partners or customers in its markets of interest. At times, competitors or other third parties may adopt trade names or trademarks similar to Q32’s, thereby impeding its ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of Q32’s registered or unregistered trademarks or trade names. Over the long term, if Q32 is unable to establish name recognition based on its trademarks and trade names, then Q32 may not be able to compete effectively, and its business may be adversely affected. Q32’s efforts to enforce or protect its proprietary rights related to trademarks, trade names, domain name or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely affect Q32’s business, financial condition, results of operations and prospects.

Numerous factors may limit any potential competitive advantage provided by Q32’s intellectual property rights.

The degree of future protection afforded by Q32’s intellectual property rights, whether owned or in-licensed, is uncertain because intellectual property rights have limitations, and may not adequately protect Q32’s business, provide a barrier to entry against its competitors or potential competitors, or permit Q32 to maintain its competitive advantage. Moreover, if a third party has intellectual property rights that cover the

practice of its technology, Q32 may not be able to fully exercise or extract value from its intellectual property

 

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rights. The factors that may limit any potential competitive advantage provided by Q32’s intellectual property rights include:

 

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pending patent applications that Q32 may file or license may not lead to issued patents;

 

  •  

patents, should they issue, that Q32 owns or licenses, may not provide Q32 with any competitive advantages, or may be challenged and held invalid or unenforceable;

 

  •  

others may be able to develop and/or practice technology that is similar to Q32’s technology or aspects of its technology but that is not covered by the claims of any of Q32’s owned or in-licensed patents, should any such patents issue;

 

  •  

third parties may compete with Q32 in jurisdictions where Q32 does not pursue and obtain patent protection;

 

  •  

Q32 (or Q32’s licensors) might not have been the first to make the inventions covered by a pending patent application that Q32 owns or licenses;

 

  •  

Q32 (or Q32’s licensors) might not have been the first to file patent applications covering a particular invention;

 

  •  

others may independently develop similar or alternative technologies without infringing Q32’s intellectual property rights;

 

  •  

Q32 may not be able to obtain and/or maintain necessary licenses on reasonable terms or at all;

 

  •  

third parties may assert an ownership interest in Q32’s intellectual property and, if successful, such disputes may preclude Q32 from exercising exclusive rights, or any rights at all, over that intellectual property;

 

  •  

Q32 may not be able to maintain the confidentiality of its trade secrets or other proprietary information;

 

  •  

Q32 may not develop or in-license additional proprietary technologies that are patentable; and

 

  •  

the patents of others may have an adverse effect on Q32’s business.

Should any of these events occur, they could significantly harm Q32’s business and results of operation.

Risks Related to Government Regulation

The regulatory approval processes of the FDA and other comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable. If Q32 is not able to obtain, or if there are delays in obtaining, required regulatory approvals for its product candidates, Q32 will not be able to commercialize, or will be delayed in commercializing, such product candidates, and its ability to generate revenue will be materially impaired.

The process of obtaining regulatory approvals, both in the U.S. and abroad, is unpredictable, expensive and typically takes many years following commencement of clinical trials, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved. Q32 cannot commercialize product candidates in the U.S. without first obtaining regulatory approval from the FDA. Similarly, Q32 cannot commercialize product candidates outside of the U.S. without obtaining regulatory approval from comparable foreign regulatory authorities. Before obtaining regulatory approvals for the commercial sale of its product candidates, including its most advanced product candidates, bempikibart and ADX-097, Q32 must demonstrate through lengthy, complex and expensive preclinical and clinical trials that such product candidates are both safe and effective for each targeted indication. Securing regulatory approval also requires the submission of information about the drug manufacturing process to, and inspection of manufacturing facilities by, the relevant regulatory authority. Further, a product candidate may not be effective, may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude its obtaining marketing approval. The FDA and comparable foreign regulatory authorities have substantial discretion in the approval process and may refuse to accept any

 

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application or may decide that its data are insufficient for approval and require additional preclinical, clinical or other data. A product candidate could be delayed in receiving, or fail to receive, regulatory approval for many reasons, including:

 

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the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of its clinical trials;

 

  •  

Q32 may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective for its proposed indication;

 

  •  

the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;

 

  •  

serious and unexpected drug-related side effects may be experienced by participants in its clinical trials or by individuals using drugs similar to a product candidate, which may result in inquiries from or actions by regulatory authorities to address such events;

 

  •  

Q32 may be unable to demonstrate that a candidate’s clinical and other benefits outweigh its safety risks;

 

  •  

the FDA or comparable foreign regulatory authorities may disagree with its interpretation of data from preclinical studies or clinical trials;

 

  •  

the data collected from clinical trials of a product candidate may not be acceptable or sufficient to support the submission of a BLA, NDA or similar marketing application to obtain regulatory approval in the U.S. or elsewhere, and Q32 may be required to conduct additional clinical trials;

 

  •  

the FDA or the applicable foreign regulatory authority may disagree regarding the formulation, labeling and/or the specifications of a product candidate;

 

  •  

the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which Q32 may contract for clinical and commercial supplies; and

 

  •  

the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering Q32’s clinical data insufficient for approval.

Of the large number of drugs in development, only a small percentage successfully complete the FDA or foreign regulatory approval processes and are commercialized. The lengthy approval process as well as the unpredictability of future clinical trial results may result in Q32 failing to obtain regulatory approval to market bempikibart, ADX-097 or other product candidates, which would significantly harm its business, results of operations and prospects.

If Q32 were to obtain approval, regulatory authorities may approve any such product candidate for fewer or more limited indications than Q32 requests, including failing to approve the most commercially promising indications, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. If Q32 is not able to obtain, or if there are delays in obtaining, required regulatory approvals for a product candidate, Q32 will not be able to commercialize, or will be delayed in commercializing, such product candidate and its ability to generate revenue may be materially impaired.

 

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Inadequate funding for the FDA, the SEC and other government agencies, including from government shutdowns, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of Q32’s business may rely, which could negatively impact its business.

The ability of the FDA to review and approve regulatory submissions can be affected by a variety of factors, including government budget and funding levels, the ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which Q32’s operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may also slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies, which would adversely affect Q32’s business. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process regulatory submissions, which could have a material adverse effect on Q32’s business. Further, future government shutdowns could impact the company’s ability to access the public markets and obtain necessary capital to properly capitalize and continue its operations.

Q32 may not be able to meet requirements for the chemistry, manufacturing and control of its product candidates.

In order to receive approval of its products by the FDA and comparable foreign regulatory authorities, Q32 must show that Q32 and its contract manufacturing partners are able to characterize, control and manufacture its drug and biologic products safely and in accordance with regulatory requirements. This includes synthesizing the active ingredient, developing an acceptable formulation, performing tests to adequately characterize the formulated product, documenting a repeatable manufacturing process and demonstrating that its products meet stability requirements. Meeting these chemistry, manufacturing and control, or CMC, requirements is a complex task that requires specialized expertise. If Q32 is not able to meet the CMC requirements, Q32 may not be successful in advancing its clinical studies or obtaining regulatory approvals for its product candidates.

Q32 has and may in the future conduct clinical trials for its product candidates at sites outside the U.S., and the FDA may not accept data from trials conducted in such locations.

Q32 has and may in the future choose to conduct clinical trials for ADX-097 or other product candidates outside the U.S. Although the FDA may accept data from clinical trials conducted outside the U.S., acceptance of this data is subject to conditions imposed by the FDA. For example, the clinical trial must be well designed and conducted and performed by qualified investigators in accordance with ethical principles. The trial population must also adequately represent the U.S. population, and the data must be applicable to the U.S. population and U.S. medical practice in ways that the FDA deems clinically meaningful. In addition, while these clinical trials are subject to the applicable local laws, FDA acceptance of the data will depend on its determination that the trials also complied with all applicable U.S. laws and regulations. If the FDA does not accept the data from any trial that Q32 conducts outside the U.S., it would likely result in the need for additional trials, which would be costly and time-consuming and would delay or permanently halt its development of the applicable product candidates. Even if the FDA accepted such data, it could require Q32 to modify its planned clinical trials to receive clearance to initiate such trials in the U.S. or to continue such trials once initiated.

Other risks inherent in conducting international clinical trials include:

 

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the need to comply with foreign regulatory requirements, differences in healthcare services, and differences in cultural customs that could restrict or limit its ability to conduct its clinical trials;

 

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administrative burdens of conducting clinical trials under multiple sets of foreign regulations;

 

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foreign exchange fluctuations;

 

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diminished protection of intellectual property in some countries; and

 

  •  

political and economic risks relevant to foreign countries.

Q32’s product candidates for which it intends to seek approval as biologics may face competition sooner than anticipated.

The Biologics Price Competition and Innovation Act of 2009, or BPCIA, was enacted as part of the ACA to establish an abbreviated pathway for the approval of biosimilar and interchangeable biological products. The regulatory pathway establishes legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar as “interchangeable” based on its similarity to an approved biologic. Under the BPCIA, an application for a highly similar or “biosimilar” product may not be submitted to the FDA until four years following the date that the reference product was first approved by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from the date on which the reference product was first approved. During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing the sponsor’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of their product.

Q32’s investigational biological products, if approved, could be considered reference products entitled to the 12-year period of exclusivity. However, there is a risk that this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider a product candidate to be reference products for competing products, potentially creating the opportunity for competition sooner than anticipated. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject of litigation. Moreover, the extent to which a biosimilar, once approved, will be substituted for any reference products in a way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing. The approval of a biosimilar of any of Q32’s product candidates could have a material adverse impact on its business due to increased competition and pricing pressure.

Even if Q32 receives regulatory approval of bempikibart, ADX-097 or other product candidates, Q32 will be subject to extensive ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and Q32 may be subject to penalties if Q32 fails to comply with regulatory requirements or experience unanticipated problems with its product candidates.

Any regulatory approvals that Q32 may receive for bempikibart, ADX-097 or other product candidates will require the submission of reports to regulatory authorities and surveillance to monitor the safety and efficacy of such product candidates, may contain significant limitations related to use restrictions for specified age groups, warnings, precautions or contraindications, and may include burdensome post-approval study or risk management requirements. For example, the FDA may require a risk evaluation and mitigation strategy in order to approve a product candidate, which could entail requirements for a medication guide, physician training and communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. In addition, if the FDA or comparable foreign regulatory authorities approve a product candidate, the products and the activities associated with their development and commercialization, including their design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale, distribution, import and export will be subject to comprehensive regulation by the FDA and other regulatory agencies in the U.S. and by comparable foreign regulatory authorities. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as ongoing compliance with cGMPs and GCPs for any clinical trials that Q32 conducts

 

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following approval. In addition, manufacturers of drug products and their facilities are subject to continual review and periodic, unannounced inspections by the FDA and other regulatory authorities for compliance with cGMPs.

If Q32 or a regulatory authority discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facilities where the product is manufactured, a regulatory authority may impose restrictions on that product, the manufacturing facility or Q32, including requiring recall or withdrawal of the product from the market or suspension of manufacturing, restrictions on its ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned trials, restrictions on the manufacturing process, warning or untitled letters, civil and criminal penalties, injunctions, product seizures, detentions or import bans, voluntary or mandatory publicity requirements and imposition of restrictions on operations, including costly new manufacturing requirements. The occurrence of any event or penalty described above may inhibit Q32’s ability to commercialize bempikibart, ADX-097 or other product candidates and generate revenue and could require Q32 to expend significant time and resources in response and could generate negative publicity.

Q32 may face difficulties from healthcare legislative reform measures.

Existing regulatory policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of bempikibart, ADX-097 or other product candidates. Q32 cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the U.S. or abroad. If Q32 is slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if Q32 is not able to maintain regulatory compliance, Q32 may lose any marketing approval that Q32 may have obtained and Q32 may not achieve or sustain profitability. See the section titled “Q32’s Business-Government Regulation-Healthcare Reform” elsewhere in this proxy statement/prospectus for a more detailed description of healthcare reforms measures that may prevent Q32 from being able to generate revenue, attain profitability, or commercialize product candidates.

The continuing efforts of the government, insurance companies, managed care organizations and other payers of healthcare services to contain or reduce costs of healthcare may adversely affect:

 

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the demand for any of Q32’s product candidates, if approved;

 

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the ability to set a price that Q32 believes is fair for any of its product candidates, if approved;

 

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Q32’s ability to generate revenues and achieve or maintain profitability;

 

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the level of taxes that Q32 is required to pay; and

 

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the availability of capital.

Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical and biologic products. Q32 cannot be sure whether additional legislative changes will be enacted, or whether FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of Q32’s product candidates, if any, may be. In addition, increased scrutiny by the U.S. Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject Q32 to more stringent product labeling and post-marketing testing and other requirements.

Q32 expects that the healthcare reform measures that have been adopted and may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that Q32 receives for any approved product and could seriously harm its future revenues. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent Q32 from being able to generate revenue, attain profitability or commercialize its products.

 

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Q32’s business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable healthcare regulatory laws, which could expose Q32 to penalties.

Q32’s business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers may expose Q32 to fraud and abuse and other healthcare laws and regulations. These laws may constrain the business or financial arrangements and relationships through which Q32 conducts its operations, including how Q32 researches, markets, sells and distributes its product candidates, if approved. See the section titled “Q32’s Business-Government Regulation-Other Healthcare Laws and Compliance Requirements” elsewhere in this proxy statement/prospectus for a more detailed description of the laws that may affect its ability to operate.

Ensuring that its internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. If Q32’s operations are found to be in violation of any of these laws or any other governmental laws and regulations that may apply to it, Q32 may be subject to significant penalties, including civil, criminal and administrative penalties, damages, fines, exclusion from government-funded healthcare programs, integrity oversight and reporting obligations to resolve allegations of non-compliance, disgorgement, individual imprisonment, contractual damages, reputational harm, diminished profits and the curtailment or restructuring of its operations. Further, defending against any such actions can be costly and time-consuming and may require significant personnel resources. Therefore, even if Q32 is successful in defending against any such actions that may be brought against Q32, its business may be impaired.

Even if Q32 is able to commercialize bempikibart, ADX-097 or other product candidates, due to unfavorable pricing regulations and/or third-party coverage and reimbursement policies, Q32 may not be able to offer such products at competitive prices which would seriously harm its business.

Q32 intends to seek approval to market bempikibart, ADX-097 and other product candidates in both the U.S. and in selected foreign jurisdictions. If Q32 obtains approval in one or more foreign jurisdictions for such product candidates, Q32 will be subject to rules and regulations in those jurisdictions. Its ability to successfully commercialize any product candidates that Q32 may develop will depend in part on the extent to which reimbursement for these products and related treatments will be available from government health administration authorities, private health insurers and other organizations. Government authorities and other third-party payors, such as private health insurers and health maintenance organizations, decide which medications they will pay for and establish reimbursement levels. Government authorities and other third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for medications. These entities may create preferential access policies for a competitor’s product, including a branded or generic/biosimilar product, over its products in an attempt to reduce their costs, which may reduce its commercial opportunity. Additionally, if any of its product candidates are approved and Q32 is found to have improperly promoted off-label uses of those programs, Q32 may become subject to significant liability, which would materially adversely affect its business and financial condition. See the sections titled “Business-Government Regulation-Coverage and Reimbursement” and “-Regulation in the EU” elsewhere in this proxy statement/prospectus for a more detailed description of the government regulations and third-party payor practices that may affect Q32’s ability to commercialize its product candidates.

Q32 is subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Q32 can face criminal liability and other serious consequences for violations, which can harm its business.

Q32 is subject to export control and import laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations, various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Controls, the U.S. Foreign Corrupt Practices Act of 1977, as amended, the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel Act, the USA

 

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PATRIOT Act, and other state and national anti-bribery and anti-money laundering laws in the countries in which Q32 conducts activities. Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, contractors, and other collaborators from authorizing, promising, offering, or providing, directly or indirectly, improper payments or anything else of value to or from recipients in the public or private sector. Q32 may engage third parties to sell products outside the U.S., to conduct clinical trials, and/or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals. Q32 has direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations. Q32 can be held liable for the corrupt or other illegal activities of its employees, agents, contractors, and other collaborators, even if Q32 does not explicitly authorize or have actual knowledge of such activities. Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences.

Governments outside the U.S. tend to impose strict price controls, which may adversely affect Q32’s revenue, if any.

In some countries, particularly Member States of the EU, the pricing of prescription drugs is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after receipt of marketing approval for a therapeutic. In addition, there can be considerable pressure by governments and other stakeholders on prices and reimbursement levels, including as part of cost containment measures. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained. Reference pricing used by various EU Member States and parallel distribution, or arbitrage between low-priced and high-priced Member States, can further reduce prices. To obtain coverage and reimbursement or pricing approvals in some countries, Q32 or current or future collaborators may be required to conduct a clinical trial or other studies that compare the cost-effectiveness of a product to other available therapies in order to obtain or maintain reimbursement or pricing approval. Publication of discounts by third-party payors or authorities may lead to further pressure on the prices or reimbursement levels within the country of publication and other countries. If reimbursement of any product approved for marketing is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, its business, financial condition, results of operations or prospects could be materially and adversely affected.

Q32 may seek one or more designations or expedited programs for its product candidates, but may not receive such designations or be allowed to proceed on expedited program pathways, and even if Q32 does receive such designations and proceed on such expedited program pathways in the future, such designations or expedited programs may not lead to a faster development or regulatory review or approval process, and each designation does not increase the likelihood that any of Q32’s product candidates will receive regulatory approval in the U.S.

Q32 may seek fast track designation for some of its product candidates. If a drug is intended for the treatment of a serious or life-threatening condition and nonclinical or clinical data for the drug demonstrates the potential to address an unmet medical need for such a condition, the drug sponsor may apply for fast track designation. The FDA has broad discretion whether to grant this designation, so even Q32 believes a particular product candidate is eligible for this designation, the company cannot provide assurance that the FDA would decide to grant this designation. Even if Q32’s candidates receive fast track designation, these candidates may not experience a faster development process, review or approval compared to conventional FDA procedures. The FDA may withdraw fast track designation if it believes that the designation is no longer supported by data from the clinical development program. Fast track designation alone does not guarantee qualification for the FDA’s priority review procedures.

Q32 may seek a breakthrough therapy designation for some of its product candidates. A breakthrough therapy is defined as a drug that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug may

 

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demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For drugs that have been designated as breakthrough therapies, interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens. Drugs designated as breakthrough therapies by the FDA may also be eligible for priority review and accelerated approval. Designation as a breakthrough therapy is within the discretion of the FDA. Accordingly, even if Q32 believes one of its product candidates meets the criteria for designation as a breakthrough therapy, the FDA may disagree and instead determine not to make such designation. In any event, the receipt of a breakthrough therapy designation for a product candidate may not result in a faster development process, review or approval compared to therapies considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA. In addition, even if one or more of Q32’s product candidates qualify as breakthrough therapies, the FDA may later decide that such product candidates no longer meet the conditions for qualification or decide that the time for FDA review or approval will not be shortened.

In the future, Q32 may also seek approval of product candidates under the FDA’s accelerated approval pathway. A product may be eligible for accelerated approval if it is designed to treat a serious or life-threatening disease or condition and generally provides a meaningful advantage over available therapies upon a determination that the product candidate has an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit. The FDA considers a clinical benefit to be a positive therapeutic effect that is clinically meaningful in the context of a given disease, such as irreversible morbidity or mortality. For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. An intermediate clinical endpoint is a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit. The accelerated approval pathway may be used in cases in which the advantage of a new drug over available therapy may not be a direct therapeutic advantage but is a clinically important improvement from a patient and public health perspective. If granted, accelerated approval is usually contingent on the sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe the drug’s clinical benefit. Under the Food and Drug Omnibus Reform Act of 2022, or the FDORA, the FDA is permitted to require, as appropriate, that a post-approval confirmatory study or studies be underway prior to approval or within a specified time after the date of accelerated approval was granted. FDORA also requires sponsors to send updates to the FDA every 180 days on the status of such studies, including progress toward enrollment targets, and the FDA must promptly post this information publicly. FDORA also gives the FDA increased authority to withdraw approval of a drug or biologic granted accelerated approval on an expedited basis if the sponsor fails to conduct such studies in a timely manner, send the necessary updates to the FDA, or if such post-approval studies fail to verify the drug’s predicted clinical benefit. Under FDORA, the FDA is empowered to act, such as issuing fines, against companies that fail to conduct with due diligence any post-approval confirmatory study or submit timely reports to the agency on their progress. In addition, for products being considered for accelerated approval, the FDA generally requires, unless otherwise informed by the Agency, that all advertising and promotional materials intended for dissemination or publication within 120 days of regulatory approval be submitted to the Agency for review during the pre-approval review period. There can be no assurance that the FDA would allow any of the product candidates Q32 may develop to proceed on an accelerated approval pathway, and even if the FDA did allow such pathway, there can be no assurance that such submission or application will be accepted or that any expedited development, review or approval will be granted on a timely basis, or at all. Moreover, even if Q32 received accelerated approval, any post-approval studies required to confirm and verify clinical benefit may not show such benefit, which could lead to withdrawal of any approvals the company has obtained. Receiving accelerated approval does not assure that the product’s accelerated approval will eventually be converted to a traditional approval.

If the FDA determines that a product candidate offers a treatment for a serious condition and, if approved, the product would provide a significant improvement in safety or effectiveness, the FDA may designate the

 

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product candidate for priority review. A priority review designation means that the goal for the FDA to review an application is six months, rather than the standard review period of ten months. Q32 may request priority review for its product candidates. The FDA has broad discretion with respect to whether to grant priority review status to a product candidate, so even if Q32 believes a particular product candidate is eligible for such designation or status, the FDA may decide not to grant it. Moreover, a priority review designation does not necessarily result in an expedited regulatory review or approval process or necessarily confer any advantage with respect to approval compared to conventional FDA procedures. Receiving priority review from the FDA does not guarantee approval within the six-month review cycle or at all.

Q32 may pursue orphan drug designation for certain of its product candidates, but may not be able to obtain such designation, or obtain or maintain the benefits of such designation including orphan drug exclusivity, and even if Q32 does obtain orphan designation for its product candidates, any orphan drug exclusivity it receives may not prevent regulatory authorities from approving other competing products.

Q32 may seek orphan drug designation for some of its product candidates; however, Q32 may never receive such designation. Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a drug or biologic intended to treat a rare disease or condition, defined as a patient population of fewer than 200,000 in the U.S., or a patient population of 200,000 or more in the U.S. where there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the U.S. Orphan drug designation must be requested before submitting an NDA or a BLA. A similar regulatory scheme governs orphan products in the EU.

Orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and application fee waivers. After the FDA grants orphan drug designation, the generic identity of the drug and its potential orphan use are disclosed publicly by the FDA. In addition, if a product candidate with an orphan drug designation subsequently receives the first regulatory approval for the indication for which it has such designation, the product is entitled to a period of marketing exclusivity, which precludes the FDA from approving another marketing application for the same product for the same therapeutic indication for seven years.

Even if Q32 obtains orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different products can be approved for the same condition. In addition, even after an orphan drug is approved, the FDA can subsequently approve the same product for the same condition if the FDA concludes that the later product is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care. Orphan drug exclusivity may also be lost if the FDA determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the product to meet the needs of the patients with the rare disease or condition. Further, even if Q32 obtains orphan drug designation, the company may not be the first to obtain regulatory approval for any indication due to the uncertainties associated with developing pharmaceutical products.

The FDA may further reevaluate the Orphan Drug Act and its regulations and policies. Additionally, legislation has been proposed by the European Commission that, if implemented, has the potential in some cases to shorten the ten-year period of orphan marketing exclusivity. It is unclear if, when, or how the FDA or other regulatory authorities may change the orphan drug regulations and policies in the future, and it is uncertain how any changes might affect Q32’s business. Depending on what changes the FDA or other regulatory authorities may make to their orphan drug regulations and policies, the company’s business could be adversely impacted.

Q32 may be subject to claims that Q32 or its employees or consultants have wrongfully used or disclosed alleged trade secrets of employees’ or consultants’ former employers or their clients. These claims may be costly to defend and if Q32 does not successfully do so, it may be required to pay monetary damages and may lose valuable intellectual property rights or personnel.

Many of Q32’s employees were previously employed at universities or biotechnology or pharmaceutical companies, including its competitors or potential competitors. Although no claims against Q32 are currently

 

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pending, it may be subject to claims that these employees or Q32 have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. If Q32 fails in defending such claims, in addition to paying monetary damages, Q32 may lose valuable intellectual property rights or personnel. A loss of key research personnel or their work product could hamper Q32’s ability to develop and commercialize, or prevent it from developing and commercializing, its product candidates, which could severely harm its business. Even if Q32 is successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.

Risks Related to Q32’s Third Party Relationships

Q32 currently relies and expects to rely on third parties in the future to conduct its clinical trials and some aspects of its research, as well as some aspects of its delivery methods, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research or testing.

Q32 currently, and expects to continue to, rely on third parties, such as but not limited to CROs, clinical data management organizations, medical institutions, preclinical laboratories and clinical investigators, to conduct some aspects of its research. For example, Q32 may rely on a third party to supply components of its product candidates, or to conduct some of its preclinical animal experiments. Any of these third parties may terminate their engagements with Q32 at any time under certain criteria. If Q32 needs to enter into alternative arrangements, it may delay its product research and development activities.

Q32’s reliance on these third parties for research and development activities will reduce its control over these activities but will not relieve Q32 of its responsibilities. For example, Q32 will remain responsible for ensuring that each of its preclinical studies and clinical trials is conducted in accordance with the general investigational plan and protocols. Moreover, the FDA, the EMA and other regulatory authorities require Q32 and the study sites and investigators Q32 works with to comply with standards, commonly referred to as GLPs and GCPs for conducting, recording and reporting the results of preclinical studies and clinical trials to assure, amongst other things, that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected.

Q32 has collaborations and license agreements with third parties, including its existing license agreements with BMS and Colorado and expects to collaborate with third parties in the future. Q32 may not be successful in finding strategic collaborators for continuing development of certain of its future product candidates or successfully commercializing or competing in the market for certain indications.

Q32 currently collaborates with third-parties with respect to bempikibart and ADX-097. If any of Q32’s collaborators, licensors or licensees experience delays in performance of, or fail to perform their obligations under, their applicable agreements with Q32, disagree with its interpretation of the terms of such agreement or terminate their agreement with Q32, its pipeline of product candidates would be adversely affected. If Q32 fails to comply with any of the obligations under its collaborations or license agreements, including payment terms and diligence terms, its collaborators, licensors or licensees may have the right to terminate its agreements, in which event Q32 may lose intellectual property rights, market or sell the products covered by such agreements or may face other penalties under such agreements. Q32’s collaborators, licensors or licensees may also fail to properly maintain or defend the intellectual property Q32 has licensed from them, or infringe upon other third party intellectual property rights, leading to the potential invalidation of such third party’s intellectual property or subjecting Q32 to litigation or arbitration, any of which would be time-consuming and expensive and could harm Q32’s ability to develop or commercialize its product candidates. Further, any of these relationships may require Q32 to increase its near and long-term expenditures, issue securities that dilute its existing stockholders or disrupt its management and business. In addition, collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with Q32’s product candidates and products if the collaborators believe that the competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than under the agreements with Q32.

 

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In the future, Q32 may decide to collaborate with entities such as, but not limited to, non-profit organizations, universities, pharmaceutical and biotechnology companies for the development and potential commercialization of existing and new product candidates. Q32 faces significant competition in seeking appropriate collaborators. Whether Q32 reaches a definitive agreement for a collaboration will depend, among other things, upon its assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of several factors. Those factors may include the design or results of clinical trials, the likelihood of approval by the FDA or similar regulatory authorities outside the U.S., the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of competing drugs, the existence of uncertainty with respect to Q32’s ownership of technology, which can exist if there is a challenge to such ownership without regard to the merits of the challenge and industry and market conditions generally. The collaborator may also consider alternative product candidates or technologies for similar indications that may be available to collaborate on and whether such a collaboration could be more attractive than the one with Q32 for its product candidate. The terms of any additional collaborations or other arrangements that Q32 may establish may not be favorable to Q32. Collaborations are complex and time-consuming to negotiate and document. In addition, there have been a significant number of recent business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators.

Q32 may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all. If Q32 is unable to do so, it may have to curtail the development of the product candidate for which Q32 is seeking to collaborate, reduce or delay its development program or one or more of Q32’s other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase its expenditures and undertake development or commercialization activities at its own expense. If Q32 elects to increase its expenditures to fund development or commercialization activities on its own, Q32 may need to obtain additional capital, which may not be available to it on acceptable terms or at all. If Q32 does not have sufficient funds, it may not be able to further develop its product candidates or bring them to the market and generate product revenue.

The success of any potential collaboration arrangements will depend heavily on the efforts and activities of Q32’s collaborators. Collaborators generally have significant discretion in determining the efforts and resources that they will apply to these collaborations. Disagreements between parties to a collaboration arrangement regarding clinical development and commercialization matters can lead to delays in the development process or commercializing the applicable product candidate and, in some cases, termination of such collaboration arrangements. These disagreements can be difficult to resolve if neither of the parties has final decision-making authority. Collaborations with pharmaceutical or biotechnology companies and other third parties often are terminated or allowed to expire by the other party. Any such termination or expiration would adversely affect Q32 financially and could harm its business reputation.

Future acquisitions or strategic alliances could disrupt Q32’s business and harm its financial condition and results of operations.

Q32 may acquire additional businesses or drugs, form strategic alliances or create joint ventures with third parties that it believes will complement or augment its existing business. If Q32 acquires businesses with promising markets or technologies, it may not be able to realize the benefit of acquiring such businesses if Q32 is unable to successfully integrate them with its existing operations and company culture. Q32 may encounter numerous difficulties in developing, manufacturing and marketing any new drugs resulting from a strategic alliance or acquisition that delay or prevent it from realizing their expected benefits or enhancing its business. Q32 cannot assure you that, following any such acquisition, it will achieve the expected synergies to justify the transaction. The risks Q32 faces in connection with acquisitions, include:

 

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diversion of management time and focus from operating its business to addressing acquisition integration challenges;

 

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coordination of research and development efforts;

 

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retention of key employees from the acquired company;

 

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changes in relationships with strategic partners because of product acquisitions or strategic positioning resulting from the acquisition;

 

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cultural challenges associated with integrating employees from the acquired company into Q32;

 

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the need to implement or improve controls, procedures, and policies at a business that prior to the acquisition may have lacked sufficiently effective controls, procedures and policies;

 

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liability for activities of the acquired company before the acquisition, including intellectual property infringement claims, violation of laws, commercial disputes, tax liabilities, and other known liabilities;

 

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unanticipated write-offs or charges; and

 

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litigation or other claims in connection with the acquired company, including claims from terminated employees, customers, former stockholders or other third parties.

Q32’s failure to address these risks or other problems encountered in connection with its past or future acquisitions or strategic alliances could cause it to fail to realize the anticipated benefits of these transactions, cause it to incur unanticipated liabilities and harm the business generally. There is also a risk that future acquisitions will result in the incurrence of debt, contingent liabilities, amortization expenses or incremental operating expenses, any of which could harm Q32’s financial condition or results of operations.

Q32 relies, and anticipates that it will rely, on third parties to assist in designing, conducting, supervising and monitoring its preclinical studies and clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm its business.

Q32 relies, and anticipates that it will rely, on third party clinical investigators, CROs, clinical data management organizations and consultants to help design, conduct, supervise and monitor preclinical studies and clinical trials of its product candidates. Because Q32 relies on third parties and does not have the ability to conduct preclinical studies or clinical trials independently, Q32 has less control over the timing, quality and other aspects of preclinical studies and clinical trials than it would if it conducted them on its own, including Q32’s inability to control whether sufficient resources are applied to its programs. If any of Q32’s CROs are acquired or consolidated, these concerns are likely to be exacerbated and its preclinical studies or clinical trials may be further impacted due to potential integration, streamlining, staffing and logistical changes. These investigators, CROs and consultants are not Q32 employees and Q32 has limited control over the amount of time and resources that they dedicate to its programs. These third parties may have contractual relationships with other entities, some of which may be Q32’s competitors, which may draw time and resources from Q32 programs. Further, these third parties may not be diligent, careful or timely in conducting Q32’s preclinical studies or clinical trials, resulting in the preclinical studies or clinical trials being delayed or unsuccessful.

If Q32 cannot contract with acceptable third parties on commercially reasonable terms, or at all, or if these third parties do not carry out their contractual duties, satisfy legal and regulatory requirements for the conduct of preclinical studies or clinical trials or meet expected deadlines, Q32’s preclinical and clinical development programs could be delayed and otherwise adversely affected. In all events, Q32 is responsible for ensuring that each of its preclinical studies and clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. The FDA and other health authorities require certain preclinical studies to be conducted in accordance with GLP, and clinical trials to be conducted in accordance with GCP, including conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of clinical trial participants are protected. If Q32 or its CROs fail to comply with these requirements, the data generated in Q32’s clinical trials may be deemed unreliable or uninterpretable and the FDA and other health authorities may require Q32 to perform additional clinical trials. Q32’s reliance on third parties that it does not control does not relieve it of these responsibilities and requirements. In the U.S., Q32 is also required to register certain clinical trials and post the

 

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results of completed clinical trials on a government-sponsored database, ClinicalTrials.gov, within certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions. Any such event could adversely affect Q32’s business, financial condition, results of operations and prospects.

Q32 relies on third parties in the supply and manufacture of its product candidates for its research, preclinical and clinical activities, and may do the same for commercial supplies of its product candidates.

Q32 has not yet manufactured its product candidates on a commercial scale and may not be able to do so for any of its product candidates. Q32 currently relies on third parties in the supply and manufacture of materials for its research, preclinical and clinical activities and may continue to do so for the foreseeable future, including if it received regulatory approval for any product candidate. Q32 may do the same for the commercial supply of its drug product, if any. Q32 uses third parties to perform additional steps in the manufacturing process, such as the filling, finishing and labeling of vials and storage and shipping of its product candidates and Q32 expects to do so for the foreseeable future. There can be no assurance that Q32’s supply of research, preclinical and clinical development drug candidates and other materials will not be limited, interrupted or restricted or will be of satisfactory quality or continue to be available at acceptable prices. Replacement of any of the third parties Q32 may engage could require significant effort and expertise because there may be a limited number of qualified replacements. In addition, raw materials, reagents, and components used in the manufacturing process, particularly those for which Q32 has no other source or supplier, may not be available, may not be suitable or acceptable for use due to material or component defects, or may introduce variability into the supply of its product candidates. Furthermore, with the increase of companies developing fusion protein based antibodies and/or monoclonal antibodies, there may be increased competition for the supply of the raw materials that are necessary to make Q32’s fusion protein based antibodies and/or monoclonal antibodies, which could severely impact the manufacturing of its product candidates.

Q32 may be unable to identify manufacturers on acceptable terms or at all because the number of potential manufacturers is limited, and they must be acceptable to the FDA or approved by foreign regulatory authorities. Suppliers and manufacturers, including Q32, must meet applicable manufacturing requirements, including compliance with cGMP regulations, and undergo rigorous facility and process validation tests required by regulatory authorities to comply with regulatory standards. In the event that any of Q32’s suppliers or manufacturers fail to comply with such requirements or to perform their obligations to Q32 in relation to quality, timing or otherwise, some of which may be out of their or Q32’s control, or if Q32’s supply of components or other materials becomes limited or interrupted for other reasons, Q32 may be forced to increase the manufacturing of the materials itself, for which its currently has limited capabilities and resources, or enter into an agreement with another third party, which it may not be able to do on reasonable terms, if at all. Any interruption of the development or operation of the manufacturing of Q32’s product candidates, such as order delays for equipment or materials, equipment malfunction, quality control and quality assurance issues, regulatory delays and possible negative effects of such delays on supply chains and expected timelines for product availability, production yield issues, shortages of qualified personnel, discontinuation of a facility or business or failure or damage to a facility resulting from natural disasters, could result in the cancellation of shipments, loss of product in the manufacturing process or a shortfall in available product candidates or materials. In some cases, the technical skills or technology required to manufacture Q32’s product candidates may be unique or proprietary to the original manufacturer and Q32 may have difficulty, or there may be contractual restrictions prohibiting Q32 from, transferring such skills or technology to another third party and a feasible alternative may not exist. These factors would increase Q32’s reliance on such manufacturer or require it to obtain a license from such manufacturer in order to have another third-party manufacture Q32’s product candidates. If Q32 is required to change manufacturers for any reason, Q32 will be required to verify that the new manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations and guidelines. The delays associated with the verification of a new manufacturer could negatively affect Q32’s ability to develop product candidates in a timely manner or within budget.

Q32 may also be required to enter into long-term manufacturing agreements that contain exclusivity provisions and/or substantial termination penalties which could have a material adverse effect on its business

 

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prior to or after commercialization of any of its product candidates. If Q32 is unable to obtain or maintain third-party manufacturing for product candidates, or to do so on commercially reasonable terms, Q32 may not be able to develop and commercialize its product candidates successfully. Failure to execute Q32’s manufacturing requirements, either by Q32 or by one of its third-party vendors, could adversely affect Q32’s business.

Q32’s relationships with healthcare providers, physicians, and third-party payors will be subject to applicable anti-kickback, fraud and abuse, anti-bribery and other healthcare laws and regulations, which could expose it to criminal sanctions, civil penalties, contractual damages, reputational harm, and diminished profits and future earnings.

Healthcare providers, physicians, and third-party payors play a primary role in the recommendation and prescription of any product candidates that Q32 may develop for which it obtains marketing approval. Q32’s future arrangements with third-party payors and customers may expose it to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which Q32 markets, sells, and distributes its medicines for which it obtains marketing approval. Restrictions under applicable federal and state healthcare laws and regulations listed in the section above titled “Risk Factors—Risks Related to Government Regulation,” including certain laws and regulations applicable only if Q32 has marketed products.

Some state laws also require pharmaceutical companies to comply with specific compliance standards, restrict financial interactions between pharmaceutical companies and healthcare providers or require pharmaceutical companies to report information related to payments to health care providers or marketing expenditures.

Efforts to ensure that Q32’s business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. Given the breadth of the laws and regulations, limited guidance for certain laws and regulations and evolving government interpretations of the laws and regulations, governmental authorities may possibly conclude that Q32’s business practices may not comply with healthcare laws and regulations. If Q32’s operations are found to be in violation of any of the laws described above or any other government regulations that apply to Q32, it may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from participation in government health care programs, such as Medicare and Medicaid, imprisonment, and the curtailment or restructuring of Q32’s operations, any of which could adversely affect its business, financial condition, results of operations, and prospects.

The provision of benefits or advantages to physicians to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order, or use of medicinal products is prohibited in the EU. The provision of benefits or advantages to physicians is also governed by the national anti-bribery laws of EU Member States, such as the U.K. Bribery Act 2010. Infringement of these laws could result in substantial fines and imprisonment.

Payments made to physicians in certain EU Member States must be publicly disclosed. Moreover, agreements with physicians often must be the subject of prior notification and approval by the physician’s employer, his or her competent professional organization, and/or the regulatory authorities of the individual EU Member States. These requirements are provided in the national laws, industry codes, or professional codes of conduct applicable in the EU Member States. Failure to comply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines or imprisonment.

Risks Related to Q32’s Business, Personnel and Operations

Q32’s future growth may depend, in part, on its ability to operate in foreign markets, where Q32 would be subject to additional regulatory burdens and other risks and uncertainties.

Q32’s future growth may depend, in part, on its ability to develop and commercialize bempikibart, ADX-097 or other product candidates in foreign markets for which Q32 may rely on collaboration with third

 

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parties. Q32 is not permitted to market or promote any product candidates before Q32 receives regulatory approval from the applicable foreign regulatory authority and may never receive such regulatory approval for any product candidates. To obtain separate regulatory approval in many other countries, Q32 must comply with numerous and varying regulatory requirements of such countries regarding safety and efficacy and governing, among other things, clinical trials and commercial sales, pricing and distribution of bempikibart, ADX-097 or other product candidates, and Q32 cannot predict success in these jurisdictions. If Q32 fails to comply with the regulatory requirements in international markets or to receive applicable marketing approvals, its target market will be reduced and its ability to realize the full market potential of bempikibart, ADX-097 or other product candidates will be harmed, and its business will be adversely affected. Moreover, even if Q32 obtains approval of bempikibart, ADX-097 or other product candidates and ultimately commercialize such product candidates in foreign markets, Q32 would be subject to the risks and uncertainties, including the burden of complying with complex and changing foreign regulatory, tax, accounting and legal requirements and reduced protection of intellectual property rights in some foreign countries.

Q32’s employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, CMOs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

Q32 is exposed to the risk that its employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, CMOs, suppliers and vendors acting for or on its behalf may engage in misconduct or other improper activities. It is not always possible to identify and deter misconduct by these parties and the precautions Q32 takes to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting Q32 from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations.

Q32’s internal computer systems, or those of any of its CROs, manufacturers, other contractors, third party service providers or consultants or potential future collaborators, may fail or suffer security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of its proprietary or confidential data, employee data or personal data, which could result in additional costs, loss of revenue, significant liabilities, harm to its brand and material disruption of its operations.

Despite the implementation of security measures in an effort to protect systems that store its information, given their size and complexity and the increasing amounts of information maintained on its internal information technology systems and those of its third-party CROs, other contractors (including sites performing its clinical trials), third party service providers and supply chain companies, and consultants, as well as other partners, these systems are potentially vulnerable to breakdown or other damage or interruption from service interruptions, system malfunction, natural disasters, terrorism, war and telecommunication and electrical failures, as well as security breaches from inadvertent or intentional actions by its employees, contractors, consultants, business partners and/or other third parties, or from cyber-attacks by malicious third parties, which may compromise its system infrastructure or lead to the loss, destruction, alteration or dissemination of, or damage to, its data. To the extent that any disruption or security breach were to result in a loss, destruction, unavailability, alteration or dissemination of, or damage to, Q32’s data or applications, or for it to be believed or reported that any of these occurred, Q32 could incur liability and reputational damage and the development and commercialization of bempikibart, ADX-097 or other product candidates could be delayed.

As its employees work remotely and utilize network connections, computers, and devices outside its premises or network, including working at home, while in transit and in public locations, there are risks to its information technology systems and data. Additionally, business transactions (such as acquisitions or integrations) could expose Q32 to additional cybersecurity risks and vulnerabilities, as its systems could be negatively affected by vulnerabilities present in acquired or integrated entities’ systems and technologies.

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information technology systems because such threats and techniques change frequently, are often sophisticated in nature, and may not be detected until after a security incident has occurred. Further, Q32 may experience delays in developing and deploying remedial measures designed to address any such identified vulnerabilities. Applicable data privacy and security obligations may require Q32 to notify relevant stakeholders of security incidents. Such disclosures are costly, and the disclosure or the failure to comply with such requirements could lead to adverse consequences.

Q32 relies on third-party service providers and technologies to operate critical business systems to process sensitive information in a variety of contexts. Its ability to monitor these third parties’ information security practices is limited, and these third parties may not have adequate information security measures in place. If its third-party service providers experience a security incident or other interruption, Q32 could experience adverse consequences. While Q32 may be entitled to damages if its third-party service providers fail to satisfy their privacy or security-related obligations to Q32, any award may be insufficient to cover its damages, or Q32 may be unable to recover such award. In addition, supply-chain attacks have increased in frequency and severity, and Q32 cannot guarantee that third parties’ infrastructure in its supply chain or its third-party partners’ supply chains have not been compromised.

If Q32 (or a third party upon whom Q32 relies) experience a security incident or are perceived to have experienced a security incident, Q32 may experience adverse consequences, such as government enforcement actions (for example, investigations, fines, penalties, audits, and inspections); additional reporting requirements and/or oversight; restrictions on processing sensitive information (including personal data); litigation (including class claims); indemnification obligations; negative publicity; reputational harm; monetary fund diversions; interruptions in its operations (including availability of data); increased investigation and compliance costs; financial loss; and other similar harms. Security incidents and attendant consequences may cause stakeholders (including investors and potential customers) to stop supporting its research and development activities, deter new customers from products, and negatively impact its ability to grow and operate its business.

Q32’s contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in its contracts are sufficient to protect Q32 from liabilities, damages, or claims related to its data privacy and security obligations. Q32 cannot be sure that its insurance coverage will be adequate or sufficient to protect Q32 from or to mitigate liabilities arising out of its privacy and security practices or from disruptions in, or failure or security breach of, its systems or third-party systems where information important to its business operations or commercial development is stored, or that such coverage will continue to be available on commercially reasonable terms or at all, or that such coverage will pay future claims.

Q32 is subject to stringent and changing laws, regulations and standards, and contractual obligations relating to privacy, data protection, and data security. The actual or perceived failure to comply with such obligations could lead to government enforcement actions (which could include civil or criminal penalties), fines and sanctions, private litigation and/or adverse publicity and could negatively affect its operating results and business.

Q32, and third parties with whom Q32 works, are or may become subject to numerous domestic and foreign laws, regulations, and standards relating to privacy, data protection, and data security, the scope of which are changing, subject to differing applications and interpretations, and may be inconsistent among countries, or conflict with other rules. Q32 is or may become subject to the terms of contractual obligations related to privacy, data protection, and data security. Q32’s obligations may also change or expand as its business grows. The actual or perceived failure by Q32 or third parties related to Q32 to comply with such laws, regulations and obligations could increase its compliance and operational costs, expose Q32 to regulatory scrutiny, actions, fines and penalties, result in reputational harm, lead to a loss of customers, result in litigation and liability, and otherwise cause a material adverse effect on its business, financial condition, and results of operations. See the sections titled “Q32’s Business-Government Regulation-Data Privacy and Security” and “Other Regulatory Matters” in this proxy statement/prospectus for a more detailed description of the laws that may affect its ability to operate.

 

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If Q32 fails to comply with environmental, health and safety laws and regulations, Q32 could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of its business.

Q32 is subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. Its operations may involve the use of hazardous and flammable materials, including chemicals and biological and radioactive materials. In addition, Q32 may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair Q32’s research, development or commercialization efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

If Q32 is unable to attract and retain qualified key management and scientists, staff, consultants and advisors, its ability to implement its business plan may be adversely affected.

Q32 is highly dependent upon its senior management and its scientific, clinical and medical staff and advisors. The loss of the service of any of the members of Q32’s senior management or other key employees could delay its research and development programs and materially harm its business, financial condition, results of operations and prospects. In addition, Q32 expects that it will continue to have an increased need to recruit and hire qualified personnel as it advances its programs and expands operations. Failure to successfully recruit and retain personnel could impact Q32’s anticipated development plans and timelines. Q32 is dependent on the continued service of its technical personnel because of the highly technical and novel nature of its product candidates, platform and technologies and the specialized nature of the regulatory approval process. Replacing such personnel may be difficult and may take an extended period of time because of the limited number of individuals in Q32’s industry with the breadth of skills and experience required to successfully execute its business strategy, and Q32 cannot assure you that it will be able to identify or employ qualified personnel for any such position on acceptable terms, if at all. Many of the biotechnology and pharmaceutical companies with whom Q32 competes for qualified personnel have greater financial and other resources, different risk profiles and longer histories in the industry than Q32 does. Because Q32’s management team and key employees are not obligated to provide Q32 with continued service, they could terminate their employment with Q32 at any time without penalty. Q32 does not maintain key person life insurance policies on any of its management team members or key employees. Q32’s future success will depend in large part on its continued ability to attract and retain highly qualified scientific, technical and management personnel, as well as personnel with expertise in preclinical and clinical testing, manufacturing, governmental regulation and commercialization. In order to do so, Q32 may need to pay higher compensation or fees to its employees or consultants than it currently expects, and such higher compensation payments may have a negative effect on its operating results. Q32 faces increased competition for personnel from other companies, universities, public and private research institutions, government entities and other organizations. If Q32 is unable to attract and retain qualified personnel, the rate and success at which Q32 may be able to discover and develop its product candidates and implement its business plan will be limited.

Q32 expects to expand its research, development, delivery, manufacturing, commercialization, regulatory and future sales and marketing capabilities over time, and as a result, Q32 may encounter difficulties in managing its growth, which could disrupt its operations.

As of September 30, 2023, Q32 had 35 full-time employees, including 4 who hold Ph.D. degrees and 3 who hold M.D. degrees, and no part-time employees; 25 employees are engaged in research and development and 10 employees in management or general and administrative activities. In connection with the growth and advancement of Q32’s pipeline and becoming a public company, Q32 expects to increase the number of its employees and the scope of its operations, particularly in the areas of drug development, regulatory affairs and sales and marketing. To manage its anticipated future growth, Q32 must continue to implement and improve its managerial, operational and financial systems, expand its facilities, and continue to recruit and train additional qualified personnel. Due to Q32’s limited financial resources and the limited experience of its management team

 

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in managing a company with such anticipated growth, Q32 may not be able to effectively manage the expected expansion of its operations or recruit and train additional qualified personnel. Moreover, Q32’s current physical laboratory space may be insufficient for its near-term research and development hiring plans, and the expected physical expansion of Q32’s operations may lead to significant costs and may divert its management and business development resources. Any inability to manage growth could delay the execution of Q32’s business plans or disrupt its operations.

As a growing biotechnology company, Q32 is actively pursuing new platforms and product candidates in many therapeutic areas and across a wide range of diseases. Successfully developing product candidates for and fully understanding the regulatory and manufacturing pathways to all of these therapeutic areas and disease states requires a significant depth of talent, resources and corporate processes in order to allow simultaneous execution across multiple areas. Due to Q32’s limited resources, it may not be able to effectively manage this simultaneous execution and the expansion of its operations or recruit and train additional qualified personnel. This may result in weaknesses in Q32’s infrastructure, give rise to operational mistakes, legal or regulatory compliance failures, loss of business opportunities, loss of employees and reduced productivity among remaining employees. The physical expansion of Q32’s operations may lead to significant costs and may divert financial resources from other projects, such as the development of Q32’s potential product candidates. If Q32’s management is unable to effectively manage the expected development and expansion, Q32’s expenses may increase more than expected, its ability to generate or increase its revenue could be reduced and it may not be able to implement its business strategy. Q32’s future financial performance and its ability to compete effectively and commercialize any product candidates it may develop will depend in part on its ability to effectively manage the future development and expansion of Q32.

General Risk Factors

Q32’s estimates of market opportunity and forecasts of market growth may prove to be inaccurate, and even if the markets in which Q32 competes achieve the forecasted growth, its business may not grow at similar rates, or at all.

Q32’s market opportunity estimates and growth forecasts are subject to significant uncertainty and are based on assumptions and estimates which may not prove to be accurate. Its estimates and forecasts relating to size and expected growth of its target market may prove to be inaccurate. Even if the markets in which Q32 competes meet its size estimates and growth forecasts, its business may not grow at similar rates, or at all. Q32’s growth is subject to many factors, including its success in implementing its business strategy, which is subject to many risks and uncertainties.

Q32’s revenue will be dependent, in part, upon the size of the markets in the territories for which Q32 gains regulatory approval, the accepted price for the product, the ability to obtain coverage and reimbursement and whether Q32 owns the commercial rights for that territory. If the number of its addressable patients is not as significant as Q32 estimates, the indication approved by regulatory authorities is narrower than Q32 expects or the treatment population is narrowed by competition, physician choice or treatment guidelines, Q32 may not generate significant revenue from sales of such products, even if approved.

Q32 may become exposed to costly and damaging liability claims, either when testing a product candidate in the clinical or at the commercial stage, and its product liability insurance may not cover all damages from such claims.

Q32 is exposed to potential product liability and professional indemnity risks that are inherent in the research, development, manufacturing, marketing, and use of pharmaceutical products. While Q32 currently has no products that have been approved for commercial sale, the current and future use of a product candidate in clinical trials, and the sale of any approved products in the future, may expose Q32 to liability claims. These claims may be made by patients that use the product, healthcare providers, pharmaceutical companies, or others selling such product. Any claims against Q32, regardless of their merit, could be difficult and costly to defend

 

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and could materially and adversely affect the market for its products or any prospects for commercialization of its products. Although Q32 believes it currently maintains adequate product liability insurance for its product candidates, it is possible that its liabilities could exceed its insurance coverage or that in the future Q32 may not be able to maintain insurance coverage at a reasonable cost or obtain insurance coverage that will be adequate to satisfy any liability that may arise. If a successful product liability claim or series of claims is brought against Q32 for uninsured liabilities or in excess of insured liabilities, its assets may not be sufficient to cover such claims and its business operations could be impaired.

Litigation costs and the outcome of litigation could have a material adverse effect on Q32’s business.

From time to time, Q32 may be subject to litigation claims through the ordinary course of its business operations regarding, but not limited to, employment matters, security of patient and employee personal information, contractual relations with collaborators and intellectual property rights. Litigation to defend itself against claims by third parties, or to enforce any rights that Q32 may have against third parties, may continue to be necessary, which could result in substantial costs and diversion of its resources, causing a material adverse effect on its business, financial condition, results of operations or cash flows.

Q32’s business could be adversely affected by economic downturns, inflation, increases in interest rates, natural disasters, public health crises such as the COVID-19 pandemic, political crises, geopolitical events, such as conflict between Russia and Ukraine and the conflict in Israel and Gaza, or other macroeconomic conditions, which could have a material and adverse effect on its results of operations and financial condition.

The global economy, including credit and financial markets, has experienced extreme volatility and disruptions, including, among other things, diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, supply chain shortages, increases in inflation rates, higher interest rates, and uncertainty about economic stability. For example, the COVID-19 pandemic resulted in widespread unemployment, economic slowdown and extreme volatility in the capital markets. The Federal Reserve has raised interest rates multiple times in response to concerns about inflation and it may raise them again. Higher interest rates, coupled with reduced government spending and volatility in financial markets, may increase economic uncertainty and affect consumer spending. Similarly, the ongoing military conflict between Russia and Ukraine, the conflict in Israel and Gaza and rising tensions with China have created extreme volatility in the global capital markets and may have further global economic consequences, including disruptions of the global supply chain. Any such volatility and disruptions may adversely affect its business or the third parties on whom Q32 relies. If the equity and credit markets deteriorate, including as a result of political unrest or war, it may make any necessary debt or equity financing more costly, more dilutive, or more difficult to obtain in a timely manner or on favorable terms, if at all. Increased inflation rates can adversely affect Q32 by increasing its costs, including labor and employee benefit costs.

Q32 may in the future experience disruptions as a result of such macroeconomic conditions, including delays or difficulties in initiating or expanding clinical trials and manufacturing sufficient quantities of materials. Any one or a combination of these events could have a material and adverse effect on its results of operations and financial condition.

Q32’s ability to utilize its net operating loss carryforwards and certain other tax attributes may be limited.

Since Q32’s inception, it has incurred losses and it may never achieve profitability. As of December 31, 2022, Q32 had federal and state NOLs of $91.1 million and $85.5 million, respectively. Under current law, Q32’s federal NOLs generated in taxable years beginning after December 31, 2017, may be carried forward indefinitely, but the deductibility of such federal NOLs is limited to 80% of Q32’s taxable income annually for tax years beginning after December 31, 2020. Federal NOLs generated in taxable years beginning before January 1, 2018, however, have a 20-year carryforward period, but are not subject to the 80% limitation. Q32’s state NOLs expire at various dates from 2037 through 2042. As of December 31, 2022, Q32 had federal research

 

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and development tax credit carryforwards of $3.6 million that expire at various dates from 2038 through 2042. In addition, as of December 31, 2022, Q32 had state research and development tax credit carryforwards of $1.4 million that expire at various dates from 2037 through 2042.

Under Sections 382 and 383 of the Code, if a corporation undergoes an “ownership change,” generally defined as one or more shareholders or groups of shareholders who own at least 5 percent of the corporation’s equity increasing their equity ownership in the aggregate by more than 50 percentage points (by value) over a rolling three-year period, the corporation’s ability to use its pre-change NOLs and other pre-change tax attributes (such as research and development tax credits) to offset its post-change income or taxes may be limited. Similar rules may apply under state tax laws. Q32’s prior equity offerings and other changes in its stock ownership may have resulted in such ownership changes in the past. Q32 has not conducted a formal study to assess whether an ownership change has occurred or whether there have been multiple ownership changes since its inception. In addition, Q32 may experience ownership changes in the future as a result of future securities offering or subsequent shifts in its stock ownership, some of which are outside of its control. In particular, the Merger and the Pre-Closing Financing, if consummated, may constitute an ownership change within the meaning of Section 382 of the Code, which could eliminate or otherwise substantially limit Q32’s ability to use its NOLs and tax credit carryforwards. As a result, even if Q32 earns net taxable income in the future, its ability to use its pre-change NOLs or other pre-change tax attributes to offset U.S. federal taxable income or income taxes may be subject to limitations, which could potentially result in increased future tax liability to Q32. There is a risk that due to changes under the tax law, regulatory changes or other unforeseen reasons, Q32’s existing NOLs or business tax credits could expire or otherwise be unavailable to offset future income tax liabilities. At the state level, there may also be periods during which the use of NOLs or business tax credits is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed by Q32. For these reasons, Q32 may not be able to realize a tax benefit from the use of its NOLs or tax credits, even if it attains profitability

Changes in tax laws or in their implementation or interpretation may adversely affect Q32’s business and financial condition.

The rules dealing with U.S. federal, state and local income taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service and the U.S. Treasury Department. Changes to tax laws (which changes may have retroactive application) could adversely affect Q32’s business and financial condition. In recent years, many such changes have been made and changes are likely to continue to occur in the future. Q32 cannot predict whether, when, in what form or with what effective dates, tax laws, regulations and rulings may be enacted, promulgated or decided or whether they could increase its tax liability or require changes in the manner in which it operates in order to minimize increases in its tax liability.

Adverse developments affecting the financial services industry could adversely affect Q32’s current and projected business operations and its financial condition and results of operations.

Adverse developments that affect financial institutions, such as events involving liquidity that are rumored or actual, have in the past and may in the future lead to bank failures and market-wide liquidity problems. For example, on March 10, 2023, Silicon Valley Bank, or SVB, was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation, or FDIC, as receiver. Similarly, on March 12, 2023, Signature Bank was also swept into receivership. The U.S. Department of Treasury, the Federal Reserve Board, or the Federal Reserve, and the FDIC released a statement that indicated that all depositors of SVB would have access to all of their funds, including funds held in uninsured deposit accounts, after only one business day of closure. The U.S. Department of Treasury, FDIC and Federal Reserve have announced a program to provide up to $25 billion of loans to financial institutions secured by certain government securities held by financial institutions to mitigate the risk of potential losses on the sale of such instruments and help address liquidity pressures that may arise. There is no guarantee, however, that the U.S. Department of Treasury, FDIC and Federal Reserve will provide access to uninsured funds in the future in the event of the closure of other banks or financial institutions, or that they would do so in a timely fashion.

 

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At this time, Q32 holds substantially all of its cash on deposit at SVB (which has been assumed by First Citizens) and Q32 has not experienced any adverse impact to its current and projected business operations, financial condition or results of operations as a result of the closure of SVB or any other banks. Q32 plan to diversify its cash deposit holdings between multiple financial institutions. However, uncertainty remains over liquidity concerns in the broader financial services industry, and Q32’s business, business partners, or industry as a whole may be adversely impacted in ways that Q32 cannot predict at this time. If, for example, other banks and financial institutions enter receivership or become insolvent in the future in response to financial conditions affecting the banking system and financial markets, Q32’s ability to access its existing cash, cash equivalents and investments may be threatened.

Although Q32 expects to assess its banking relationships as it believes necessary or appropriate, Q32’s access to cash in amounts adequate to finance or capitalize its current and projected future business operations could be significantly impaired by factors that affect the financial institutions with which Q32 has banking relationships, and in turn, Q32. These factors could include, among others, events such as liquidity constraints or failures, the ability to perform obligations under various types of financial, credit or liquidity agreements or arrangements, disruptions or instability in the financial services industry or financial markets, or concerns or negative expectations about the prospects for companies in the financial services industry. These factors could also include factors involving financial markets or the financial services industry generally. The results of events or concerns that involve one or more of these factors could include a variety of material and adverse impacts on Q32’s current and projected business operations and its financial condition and results of operations. These could include, but may not be limited to, delayed access to deposits or other financial assets or the uninsured loss of deposits or other financial assets; or termination of cash management arrangements and/or delays in accessing or actual loss of funds subject to cash management arrangements.

In addition, widespread investor concerns regarding the U.S. or international financial systems could result in less favorable commercial financing terms, including higher interest rates or costs and tighter financial and operating covenants, or systemic limitations on access to credit and liquidity sources, thereby making it more difficult for Q32 to acquire financing on acceptable terms or at all. Any decline in available funding or access to its cash and liquidity resources could, among other risks, adversely impact Q32’s ability to meet its operating expenses, financial obligations or fulfill its other obligations, result in breaches of its financial and/or contractual obligations or result in violations of federal or state wage and hour laws. Any of these impacts, or any other impacts resulting from the factors described above or other related or similar factors not described above, could have material adverse impacts on Q32’s liquidity and its current and/or projected business operations and financial condition and results of operations.

In addition, one or more of Q32’s critical vendors, third party manufacturers, or other business partners could be adversely affected by any of the liquidity or other risks that are described above, which in turn, could have a material adverse effect on Q32’s current and/or projected business operations and results of operations and financial condition. Any business partner bankruptcy or insolvency, or any breach or default by a business partner, or the loss of any significant supplier relationships, could result in material adverse impacts on Q32’s current and/or projected business operations and financial condition.

 

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THE MERGER

This section and the section titled “The Merger Agreement” in this proxy statement/prospectus describe the material aspects of the Merger and the Merger Agreement. While Homology and Q32 believe that this description covers the material terms of the Merger and the Merger Agreement, it may not contain all of the information that is important to you. You should read carefully this entire proxy statement/prospectus for a more complete understanding of the Merger and the Merger Agreement and the other documents to which you are referred in this proxy statement/prospectus.

Background of the Merger

The following chronology summarizes the key meetings and events that led to the signing of the Merger Agreement. This chronology does not purport to catalogue every conversation of or among members of the Homology Board, Homology’s representatives and advisors, Q32, Q32’s representatives and advisors, and other parties.

Homology’s board of directors, or the Homology Board, together with Homology’s senior management and with the assistance of Homology’s advisors, regularly review and discuss Homology’s near and long-term operating and strategic priorities. Among other things, these reviews and discussions focus on the opportunities and risks associated with Homology’s operations, financial performance, competitive position, strategic relationships and potential long-term strategic options. The Homology Board, together with Homology’s senior management, regularly reviews potential strategic alternatives and opportunities to enhance stockholder value.

Homology historically has focused its business on its proprietary platform designed to utilize its human hematopoietic stem cell-derived adeno-associated virus vectors, or AAVHSCs, to precisely and effectively deliver single-administration genetic medicines in vivo through a nuclease-free gene editing modality, gene therapy, or gene therapy to express antibodies platform, or GTx-mAb, which is designed to produce antibodies throughout the body.

Throughout the second half of 2022, Homology engaged in a strategic review of its business and the Homology Board approved a plan to explore, review and evaluate a range of potential strategic options available to it, including, without limitation, an acquisition, merger, sale of assets, strategic partnerships or other transactions. In connection with this plan, Homology engaged TD Cowen as Homology’s financial advisor to assist in, among other things, a strategic review process in which, at the direction of the Homology Board, TD Cowen held high-level conversations with approximately 20 counterparties regarding a potential merger, sale of assets, other partnership opportunities or transactions. During this initial strategic review process, the majority of potential counterparties indicated a desire to await the results of Homology’s ongoing Phase 1 clinical trial for HMI-103 before proceeding with a potential transaction.

On July 27, 2023, Homology announced the initial results of its Phase 1 trial for HMI-103, with encouraging initial clinical data from the first dose cohort in the Phase 1 trial. However, given the limited number of subjects and some confounding effects in one of the subjects, the data from the trial was viewed as provisionally positive, but immature and inconclusive and requiring additional time and costs to enroll additional patients at higher doses. The Homology Board met several times with senior management to review the initial results of the Phase 1 trial for HMI-103. In light of the anticipated clinical development timeline and costs associated with the additional patient enrollments that would be required, combined with the general market sentiment for gene therapy and gene editing companies, on July 25, 2023, the Homology Board made a strategic decision to discontinue further development of HMI-103, reduce the Homology workforce by 86% as part of a restructuring to reduce its ongoing operating costs and publicly announce plans to evaluate strategic alternatives, including a merger, sale, or other partnership.

On July 28, 2023, at the direction of the Homology Board, TD Cowen began an initial outreach to potential strategic partners, acquirers and reverse merger parties to which Homology’s formal process letters were

 

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distributed requesting non-binding indications of interests by August 17, 2023. This initial outreach consisted of contacting 88 potential strategic and reverse merger targets to gauge interest in a potential acquisition or reverse merger with Homology. Of these companies, Homology executed confidentiality agreements with 18 counterparties, four of which contained a (i) customary “standstill” provision to facilitate the Homology Board’s oversight of the confidential discussions, subject to a “sunset” provision allowing the counterparty to submit competing acquisition proposals after the date on which Homology enters into a change in control transaction, such as the Merger, with any other counterparty and (ii) “don’t ask, don’t waive” provision preventing each party from making any requests to amend or waive the standstill, but the provision permitted each party to make such request to amend or waive the standstill if the request would not be reasonably likely to cause public disclosure of such standstill.

As of August 17, 2023 (the first bid deadline), Homology had received 22 initial indications of interest and, over the following weeks, seven additional initial indications of interest were received. Of the 29 indications of interest received, 27 were for a reverse merger, one was for a public-to-public merger, and one was for an out-licensing transaction involving assets being sold to Homology, including the following proposals from bidders that were invited to advance to later stages of the strategic alternatives process:

 

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On August 2, 2023, the Homology Board received an initial indication of interest for a reverse merger from a biotechnology company (referred to as “Bidder A”). Bidder A’s indication of interest proposed an equity valuation of Homology of $75 million and valued Bidder A at a $275 million equity valuation, with a $100 million PIPE financing, and proposed that Bidder A’s current stockholders would own 61.1% of the outstanding common stock of the combined company, Homology’s current stockholders would own 16.7% of the outstanding common stock of the combined company, and the investors in such PIPE financing would own 22.2% of the outstanding common stock of the combined company.

 

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On August 14, 2023, the Homology Board received an initial indication of interest for a reverse merger from a biotechnology company (referred to as “Bidder B”). Bidder B’s indication of interest proposed an equity valuation of Homology of $70 million and valued Bidder B at a $225 million equity valuation, with a $75 to $100 million PIPE financing, and proposed that Bidder B’s current stockholders would own 58.8% of the outstanding common stock of the combined company, Homology’s current stockholders would own 18.3% of the outstanding common stock of the combined company, and the investors in such PIPE financing would own 22.9% (assuming a PIPE financing at the midpoint of the indicated range) of the outstanding common stock of the combined company.

 

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On August 15, 2023, the Homology Board received an initial indication of interest for a reverse merger from a biotechnology company (referred to as “Bidder C”). Bidder C’s indication of interest proposed an equity valuation of Homology of $75 million and valued Bidder C at a $257 million equity valuation, with a $100 million PIPE financing, and proposed that Bidder C’s current stockholders would own 60.2% of the outstanding common stock of the combined company, Homology’s current stockholders would own 16.4% of the outstanding common stock of the combined company, and the investors in such PIPE financing would own 23.4% of the outstanding common stock of the combined company.

 

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On August 16, 2023, the Homology Board received an initial indication of interest for a reverse merger from Q32. Q32’s indication of interest proposed an equity valuation of Homology of $75 million (consisting of $60 million in cash and $15 million in listing value) and valued Q32 at a $250 million equity valuation, with a $75 million PIPE financing, and proposed that Q32’s current stockholders would own 62.5% of the outstanding common stock of the combined company, Homology’s current stockholders would own 18.8% of the outstanding common stock of the combined company, and the investors in such PIPE financing would own 18.8% of the outstanding common stock of the combined company.

 

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Also on August 16, 2023, the Homology Board received an initial indication of interest for a reverse merger from a biotechnology company (referred to as “Bidder D”). Bidder D’s indication of interest

 

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proposed an equity valuation of Homology of $70 million (consisting of $60 million in cash and $10 million in listing value) and valued Bidder D at a $223 million equity valuation, and proposed that Bidder D’s current stockholders would own 76.1% of the outstanding common stock of the combined company and Homology’s current stockholders would own 23.9% of the outstanding common stock of the combined company.

 

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On August 17, 2023, the Homology Board received an initial indication of interest for a reverse merger from a biotechnology company (referred to as “Bidder E”). Bidder E’s indication of interest proposed an equity valuation of Homology of $60 million and valued Bidder E at a $75 million equity valuation, and proposed that Bidder E’s current stockholders would own 55.7% of the outstanding common stock of the combined company and Homology’s current stockholders would own 44.3% of the outstanding common stock of the combined company.

On August 18, 2023, Homology’s senior management met with representatives of TD Cowen to review each indication of interest in detail and identified, for the Homology Board’s consideration, Q32, Bidder A, Bidder B, Bidder C, Bidder D and Bidder E as priority potential counterparties to be invited to present their respective business cases to Homology.

On August 21, 2023, at a meeting of the Homology Board with Homology’s senior management and representatives of TD Cowen and Latham & Watkins LLP, or Latham & Watkins, outside counsel to Homology, present, Homology’s senior management provided an update on the proposal process and reviewed with the Homology Board the proposals that Homology had received to date, including those from the priority potential counterparties previously identified for the Homology Board’s consideration. Following discussion, the Homology Board authorized Homology senior management to continue discussions with each of Q32, Bidder A, Bidder B, Bidder C, Bidder D and Bidder E regarding their respective indications of interest and request that each such potential counterparty meet with Homology to present their respective business cases.

At the direction of the Homology Board, on August 22, 2023, TD Cowen contacted these priority potential counterparties to schedule management presentations to Homology senior management and select members of the Homology Board.

On August 24, 2023, Bidder C conducted a management presentation on its proposal for a potential transaction to Homology senior management and select members of the Homology Board.

On August 25, 2023, each of Q32 and Bidder D conducted a management presentation on its proposal for a potential transaction to Homology senior management and select members of the Homology Board.

On August 28, 2023, Bidder E conducted a management presentation on its proposal for a potential transaction to Homology senior management and select members of the Homology Board.

On August 31, 2023, Bidder B conducted a management presentation on its proposal for a potential transaction to Homology senior management and select members of the Homology Board.

On September 1, 2023, Bidder A conducted a management presentation on its proposal for a potential transaction to Homology senior management and select members of the Homology Board.

During these management presentations and throughout the strategic alternatives review process, there were no discussions between selected bidders and Homology’s senior management regarding post-closing employment and there were no assurances of continued employment provided to Homology’s management.

Following these management presentations, on September 1, 2023, at a meeting of the Homology Board with Homology’s senior management and representatives of TD Cowen and Latham & Watkins present, the

 

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Homology Board discussed the management presentations and next steps. At this meeting, discussions included planning the delivery of feedback to and conducting due diligence on the priority potential counterparties. In connection with its discussion of priority potential counterparties, the Homology Board also determined that the respective proposals from Bidder C and Bidder E did not present compelling business cases for the long-term value for Homology’s stockholders relative to the other proposals received by Homology considering, among other factors, pipeline and data generated to date, proposed valuation, financing runway and concurrent PIPE investment, and timing and magnitude of upcoming catalysts. Following this meeting, at the direction of the Homology Board, representatives of TD Cowen contacted Q32, Bidder A, Bidder B, and Bidder D to deliver the feedback from the Homology Board (including feedback with respect to the relative valuations of Homology and the respective bidders), discuss next steps in the potential transaction processes and provide Homology’s due diligence questions to the respective potential counterparties.

On September 3, 2023, after receiving the Homology Board’s feedback, Bidder A submitted a revised indication of interest for a reverse merger. Bidder A’s revised indication of interest proposed an equity valuation of Homology of $75 million (consisting of $60 million in cash and $15 million in listing value) and valued Bidder A at a $231 million equity valuation, with $100 million in PIPE financing, and proposed that Bidder A’s current stockholders would own 56.9% of the outstanding common stock of the combined company, Homology’s current stockholders would own 18.5% of the outstanding common stock of the combined company, and the investors in such PIPE financing would own 24.6% of the outstanding common stock of the combined company.

On September 7, 2023, after receiving the Homology Board’s feedback, Q32 submitted a revised indication of interest for a reverse merger. Q32’s revised indication of interest proposed an equity valuation of Homology of $80 million (consisting of $60 million in cash and $20 million in listing value) and valued Q32 at a $225 million equity valuation, with $75 million in PIPE financing, and proposed that Q32’s current stockholders would own 59.2% of the outstanding common stock of the combined company, Homology’s current stockholders would own 21.1% of the outstanding common stock of the combined company, and the investors in such PIPE financing would own 19.7% of the outstanding common stock of the combined company.

Also on September 7, 2023, after receiving the Homology Board’s feedback, Bidder B submitted a revised indication of interest for a reverse merger. Bidder B’s revised indication of interest proposed an equity valuation of Homology of $80 million and valued Bidder A at a $225 million equity valuation, with $75 to $100 million in PIPE financing, and proposed that Bidder B’s current stockholders would own 57.3% of the outstanding common stock of the combined company, Homology’s current stockholders would own 20.4% of the outstanding common stock of the combined company, and the investors in such PIPE financing would own 22.3% (assuming a PIPE financing at the midpoint of the indicated range) of the outstanding common stock of the combined company.

Also on September 7, 2023, after receiving the Homology Board’s feedback, Bidder D submitted a revised indication of interest for a reverse merger. Bidder D’s revised indication of interest proposed an equity valuation of Homology of $80 million and valued Bidder D at a $210 million equity valuation, and proposed that Bidder D’s current stockholders would own 72.4% of the outstanding common stock of the combined company and Homology’s current stockholders would own 27.6%% of the outstanding common stock of the combined company.

Also on September 7, 2023, the Homology Board received an initial indication of interest for a reverse merger from another biotechnology company (referred to as “Bidder F”). Bidder F’s indication of interest proposed an equity valuation of Homology of $70 million and valued Bidder F at a $295 million equity valuation, with a $65 million PIPE financing, and proposed that Bidder F’s current stockholders would own 68.6% of the outstanding common stock of the combined company, Homology’s current stockholders would own 16.3% of the outstanding common stock of the combined company, and the investors in such PIPE financing would own 15.1% of the outstanding common stock of the combined company.

Also on September 7, 2023, representatives of Bidder A informed representatives of TD Cowen that Bidder A was withdrawing from the strategic alternatives process because it had entered into exclusivity with a different counterparty.

 

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On September 8, 2023, at a meeting of the Homology Board with Homology’s senior management and representatives of TD Cowen and Latham & Watkins present, the Homology Board discussed the strategic alternatives review process conducted to date. During this meeting, TD Cowen provided an update to the Homology Board regarding the new and revised indications of interest received. The Homology Board then discussed whether to select a lead counterparty with which a potential transaction could be pursued, and ultimately the Homology Board selected Q32 as the lead potential counterparty and Bidder F as the primary backup counterparty, based on, among other things, the relative valuations of Homology and the respective counterparties as well as the underlying business cases proposed by such counterparties. Further, the Homology Board authorized Homology’s senior management, with the assistance of Homology’s advisors, to prepare and deliver a term sheet for a potential reverse merger to Q32 reflecting Homology’s counterproposal.

Also on September 8, 2023, at the direction of the Homology Board, Homology’s senior management delivered to Q32 a non-binding term sheet for a reverse merger between Q32 and Homology to Q32, which term sheet included a counterproposal to the terms included in Q32’s revised indication of interest. This non-binding term sheet proposed an equity valuation of Homology of $80 million (consisting of $60 million in cash and $20 million in listing value) and valued Q32 at a $175 million equity valuation, with $75 million in PIPE financing ($30 million of which must be committed by current stockholders of Q32 prior to execution of a definitive transaction agreement), and proposed that Q32’s current stockholders would own 53.0% of the outstanding common stock of the combined company, Homology’s current stockholders would own 24.2% of the outstanding common stock of the combined company, and the investors in such PIPE financing would own 22.7% of the outstanding common stock of the combined company. Further, the term sheet proposed that proceeds from any divestiture of Legacy Assets after the closing of the proposed transactions would be returned to Homology’s pre-closing stockholders through contingent value rights.

On September 9, 2023, representatives of Q32 submitted to TD Cowen a revised draft of the non-binding term sheet, which contemplated a reverse triangular merger with Homology and included a counterproposal to the terms included in the non-binding term sheet Q32 had received from Homology on the previous day. Q32’s revised non-binding term sheet proposed an equity valuation of Homology of $80 million (consisting of $60 million in cash and $20 million in listing value) and valued Q32 at a $195 million equity valuation, with $75 million in PIPE financing ($30 million of which must be committed by current stockholders of Q32 prior to execution of a definitive transaction agreement), and proposed that Q32’s current stockholders would own 55.7% of the outstanding common stock of the combined company, Homology’s current stockholders would own 22.9% of the outstanding common stock of the combined company, and the investors in such PIPE financing would own 21.4% of the outstanding common stock of the combined company.

On September 10, 2023, representatives of Bidder F communicated to TD Cowen Bidder F’s willingness to revise the proposed valuation in its initial indication of interest to an equity valuation of Bidder F of $245 million, which under the terms of its initial indication of interest would result in Bidder F’s current stockholders owning 64.5% of the outstanding common stock of the combined company, Homology’s current stockholders owning 18.3% of the outstanding common stock of the combined company, and the investors in the proposed PIPE financing owning 17.1% of the outstanding common stock of the combined company.

On September 10, 2023, at a meeting of the Homology Board with Homology’s senior management and representatives of TD Cowen and Latham & Watkins present, Homology’s senior management and representatives of TD Cowen provided an update regarding negotiation of the non-binding term sheet with Q32, as well as the updated non-binding proposal from Bidder F. Following discussion, the Homology Board determined to proceed with execution of the non-binding term sheet with Q32 and authorized senior management to finalize the term sheet for execution.

On September 11, 2023, following discussions among representatives of Homology and representatives of Q32, Homology and Q32 agreed to a revised non-binding term sheet, which both parties executed. The agreed non-binding term sheet contemplated a reverse triangular merger between Q32 and Homology, pursuant to which Q32’s current stockholders would own 55.7% of the outstanding common stock of the combined company,

 

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Homology’s current stockholders would own 22.9% of the outstanding common stock of the combined company, and the investors in the proposed PIPE financing would own 21.4% of the combined company. In addition, the agreed-upon term sheet provided for a minimum of 30 days of exclusivity between Homology and Q32, during which time neither party could solicit or initiate any inquiry, proposal or offer from any third party relating to a competing transaction (other than sales of Legacy Assets). The exclusivity provisions of the agreed-upon term sheet provided that exclusivity would not expire until either party provided notice, but that such notice could be provided at any time beginning on October 10, 2023.

On September 16, 2023, following Homology’s execution of the term sheet with Q32, at the direction of the Homology Board, members of Homology’s senior management and representatives of TD Cowen initiated outreach to 46 potential counterparties to evaluate interest in potential transactions to acquire the Legacy Assets.

On September 18, 2023, Homology’s senior management met with members of the Homology Board to, among other things, provide an update on the proposed PIPE financing transaction. Homology’s senior management reported that they had received an update from Q32 that, as a result of challenging market conditions, an external lead investor in the proposed PIPE financing had not yet been identified.

On September 19, 2023, Homology’s senior management and representatives of Latham & Watkins and TD Cowen met with representatives of Q32, Q32’s financial advisor, Leerink, and Goodwin Procter LLP, or Goodwin, outside counsel to Q32, to discuss the initial steps in the proposed reverse merger and PIPE financing transactions.

On September 20, 2023, representatives of Leerink initiated outreach to potential investors in a PIPE financing on behalf of Q32.

On September 22, 2023, representatives of Leerink and Q32 began marketing discussions regarding the proposed PIPE financing transaction with potential investors that had responded positively to such initial outreach.

On September 24, 2023, representatives of Latham & Watkins delivered to representatives of Goodwin an initial draft of the Merger Agreement.

On October 2, 2023, representatives of Latham & Watkins delivered to representatives of Goodwin an initial draft of the CVR Agreement.

On October 4, 2023, representatives of Q32 delivered to representatives of Homology supplemental requests in connection with Q32’s ongoing due diligence.

On October 6, 2023, at a meeting of the Homology Board with Homology’s senior management and representatives of TD Cowen and Latham & Watkins present, Homology’s senior management and representatives of TD Cowen provided an update regarding negotiation of the definitive agreements and timeline for a potential announcement of the contemplated transactions with Q32.

On October 7, 2023, representatives of Goodwin delivered a revised draft of the Merger Agreement to representatives of Latham & Watkins, which, among other things, reflected Q32’s position on the permitted deductions for the determination of Homology net cash at the closing of the Merger and the calculation of transaction expenses, revised the representations and warranties of the parties, included additional covenants to be made by the parties, updated closing deliverables to be made and provided at closing of the Merger, and revised the non-solicitation, Legacy Asset Disposition and termination provisions.

On October 10, 2023, Homology filed a Form 8-K with the SEC reporting the posting of a corporate slide presentation on the Homology website related to updated HMI-103 data.

On October 11, 2023, TD Cowen provided Homology with certain disclosures for the Homology Board, indicating, among other things, that TD Cowen had no material relationships with Q32 during the approximately two-year period prior to such disclosures.

 

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On October 12, 2023, representatives of Q32 delivered to representatives of TD Cowen an initial draft of Q32’s consolidated financial model, or the October 12 Financial Model, including Q32’s anticipated expenses. The financial metrics included in the October 12 Financial Model assumed Q32’s asset, bempikibart, remained partnered with Horizon Therapeutics.

On October 14, 2023, representatives of Goodwin delivered a revised draft of the CVR Agreement to representatives of Latham & Watkins, which, among other things, requested a follow-up management discussion regarding the definition and mechanics of the “commercially reasonable efforts” that the combined company would be required to use to dispose of Legacy Assets, as well as changes to the permitted deductions to proceeds distributable to Homology stockholders and the composition of a post-closing special committee of the board of the combined company to administer the CVR Agreement.

On October 16, 2023, at the direction of Homology’s senior management, representatives of TD Cowen delivered to representatives of Leerink Homology’s supplemental requests regarding the October 12 Financial Model in connection with Homology’s ongoing due diligence review of Q32 and the proposed transactions.

On October 20, 2023, representatives of Homology and Q32 conducted a financial due diligence call with representatives of TD Cowen in attendance.

On October 23, 2023, representatives of Latham & Watkins delivered a revised draft of the Merger Agreement to representatives of Goodwin, which, among other things, clarified the Merger conversion mechanics and permitted deductions to the calculation of Homology’s net cash and the calculation of transaction expenses, revised the representations and warranties of the parties, updated the covenants of the parties, and revised the non-solicitation, Legacy Asset Disposition and termination provisions.

On October 31, 2023, Q32 notified Homology that Q32 had entered into discussions with Amgen to regain worldwide rights to bempikibart, which would result in such asset remaining wholly owned by Q32. With this new information, Q32 engaged in renewed discussions with the potential investors contemplating participation in the proposed PIPE financing transaction.

Also on October 31, 2023, representatives of Latham & Watkins delivered a revised draft of the CVR Agreement to representatives of Goodwin, which, among other things, adjusted the permitted deductions to proceeds distributable to Homology stockholders and revised the definition and mechanics of the “commercially reasonable efforts” that the combined company would be required to use to dispose of Legacy Assets.

On November 6, 2023, representatives of Q32 notified representatives of Homology that it had identified sufficient demand to pursue a $40 million PIPE financing led by its current investors and representatives of Q32 delivered to representatives of Homology an updated operating plan and supporting cash flow statements for the purpose of demonstrating sufficient financing runway for Q32 and the post-closing company through the combination of cash from the proposed $40 million PIPE financing, Homology’s pre-closing cash and capital from Q32’s existing debt facility (such proposal, the “November 6 Proposal”).

On November 7, 2023, at a meeting of the Homology Board with Homology’s senior management and representatives of TD Cowen and Latham & Watkins present, Homology’s senior management provided an update regarding negotiations with Q32 and the November 6 Proposal. Following discussion, the Homology Board determined to proceed with a transaction with Q32 on the terms outlined in the November 6 Proposal and authorized senior management to continue negotiations with Q32.

On November 8, 2023, representatives of Homology and Q32 met, together with their respective advisors, to discuss final supplemental diligence questions between the parties and a plan to advance the Merger Agreement and the transactions contemplated thereunder toward signing and announcement of such transactions.

 

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From November 8, 2023 to November 15, 2023, representatives of Homology, Q32, Leerink, Goodwin and Latham & Watkins continued to negotiate the terms of the Merger Agreement, CVR Agreement and other ancillary agreements.

On November 9, 2023, representatives of Leerink delivered a revised consolidated Q32 financial model to representatives of TD Cowen detailing anticipated expenses. The revised consolidated Q32 financial model reflected the re-acquisition of worldwide rights to bempikibart.

On November 10, 2023, representatives of Leerink informed representatives of TD Cowen that sufficient investor commitments had been received to achieve the proposed $40 million Pre-Closing Financing.

On November 12, 2023, representatives of Latham & Watkins and Goodwin met to negotiate and resolve the then-remaining open terms of the Merger Agreement, including the termination fees payable by the parties if the Merger Agreement were terminated under certain circumstances. The parties agreed to a termination fee payable by Homology to Q32 under certain circumstances of $2.4 million and a termination fee payable by Q32 to Homology under certain circumstances of $5.85 million.

Later on November 12, 2023, at a meeting of the Homology Board with Homology’s senior management and representatives of TD Cowen and Latham & Watkins present, Homology’s senior management provided an update regarding the status of negotiations of the Merger Agreement, the CVR Agreement and other ancillary agreements and the process for signing and announcement of the contemplated transactions. Homology’s senior management reported that while Homology and Q32 had made significant progress toward finalizing the terms of the contemplated transactions, a number of points remained open and the parties were not yet in a position to execute the Merger Agreement. Homology’s senior management also presented the Q32 Projections as prepared by Q32 and the adjustments made by Homology’s senior management to such model. After discussion, the Homology Board approved the Q32 Projections as prepared by Q32 management, as adjusted by the Homology Adjustments made by Homology’s senior management, for TD Cowen’s use and reliance in connection with its financial analyses and opinion.

On November 13, 2023, at a meeting of the Homology Board with Homology’s senior management and representatives of TD Cowen and Latham & Watkins present, Homology’s senior management provided a further update regarding the status of negotiations of the Merger Agreement, the CVR Agreement and other ancillary agreements and the process for signing and announcement of the contemplated transactions. Homology’s senior management reported that while Homology and Q32 had continued to make progress toward finalizing the terms of the contemplated transactions, the parties were not yet in a position to execute the Merger Agreement. At the request of the Homology Board, TD Cowen reviewed a preliminary financial analysis of the Q32 Equity Value.

Throughout November 14 and November 15, 2023, Homology and Q32 continued to discuss and work to finalize the Merger Agreement, the CVR Agreement and other ancillary agreements.

During the afternoon of November 15, 2023, a meeting of the Homology Board was held, with Homology’s senior management team and representatives from TD Cowen and Latham & Watkins present. Homology’s senior management reported that the parties had finalized all open points and the Merger Agreement, the CVR Agreement and ancillary documents were in agreed form. Latham & Watkins reviewed the final terms of the Merger Agreement with the Homology Board. At the request of the Homology Board, TD Cowen then reviewed its financial analysis of the Q32 Equity Value with the Homology Board and delivered an oral opinion, confirmed by delivery of a written opinion dated November 15, 2023, to the Homology Board to the effect that, based on and subject to the various assumptions made, procedures followed, matters considered and limitations and qualifications on the review undertaken by TD Cowen as set forth in such opinion, as of November 15, 2023, the Q32 Equity Value provided for pursuant to the Merger Agreement was fair, from a financial point of view, to Homology. After discussion, taking into account (i) Homology’s financial condition and prospects, (ii) outreach efforts conducted on behalf of Homology, (iii) Homology’s decision to no longer pursue development of

 

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HMI-103, (iv) the potential for Homology’s stockholders to benefit from the future growth of the combined company, (v) the proposed terms of the Merger Agreement and (vi) other factors described under the heading “—Homology’s Reasons for the Merger,” the Homology Board unanimously determined that the Merger Agreement and the other transactions contemplated thereby were advisable and in the best interests of Homology and its stockholders, approved and declared advisable the Merger and the other transactions contemplated under the Merger Agreement, and recommended that Homology’s stockholders vote to approve the issuance of Homology common stock in the Merger.

During the evening of November 15, 2023, Homology and Q32 executed the Merger Agreement, certain Homology stockholders executed the Homology stockholder support agreements and the Homology lock-up agreements, and certain Q32 stockholders executed the Q32 stockholder support agreements and the Q32 lock-up agreements. Before the opening of trading on Nasdaq on November 16, 2023, Homology and Q32 issued a joint press release announcing the execution of the Merger Agreement and subscription agreements for the Pre-Closing Financing and Homology filed a current report on Form 8-K with the SEC announcing the execution of the Merger Agreement.

Homology Reasons for the Merger

During the course of its evaluation of the Merger Agreement and the transactions contemplated by the Merger Agreement, Homology’s board of directors held numerous meetings, consulted with Homology’s senior management, legal counsel and financial advisor, and reviewed a significant amount of information. Homology’s board of directors considered the following factors in reaching its conclusion to approve the Merger Agreement and the transactions contemplated thereby and to recommend that the Homology stockholders approve the Merger and the issuance of shares of Homology common stock in the Merger, all of which the Homology board of directors viewed as supporting its decision:

 

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Homology’s board of directors review of the business, financial position and prospects of Homology on a standalone basis, and the determination that Homology could not reasonably be expected to fund its programs on a standalone basis without substantial additional investment;

 

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Homology’s decision, announced in July 2023, to stop further development of its programs and reduce its workforce by 86% in an effort to significantly reduce its ongoing operating costs while the Company explored, reviewed and evaluated a range of potential strategic options available to the Company, including, without limitation, an acquisition, merger, reverse merger, sale of assets, strategic partnerships or other transaction;

 

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the extensive strategic review process conducted by Homology, with the assistance of Homology’s management and legal and financial advisors, to review the range of strategic alternatives available to Homology, including a potential sale of all or a part of Homology and a potential reverse merger of Homology with a privately held biotechnology company, and which involved outreach to 88 strategic and reverse merger targets for a sale of all or a part of, or a reverse merger with, Homology;

 

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Homology’s board of directors’ view that no alternatives to the Merger (including remaining a standalone company, a liquidation or dissolution of Homology to distribute any available cash, and alternative strategic transactions) were reasonably likely to create greater value for Homology’s stockholders;

 

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Homology’s board of directors’ belief that, in the absence of substantial additional investment in Homology on a standalone basis, the Legacy Asset Disposition represents the best alternative to realize value for the Legacy Assets;

 

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the current financial market conditions and historical market prices, volatility and trading information with respect to Homology common stock, as well as the unfavorable state of the capital-raising environment for biotechnology companies in general which would make it challenging for Homology to raise additional capital;

 

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Homology’s board of directors’ belief that the $20.0 million equity value ascribed to Homology , in addition to Homology’s anticipated $60.0 million net cash position, provides value for Homology’s public company listing in addition to its net cash;

 

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Homology’s board of directors concluded that the Merger would provide Homology’s stockholders with (i) an opportunity to participate in the potential growth and value creation of the combined company following the Merger by virtue of their continued ownership of the combined company’s common stock, and (ii) the potential to receive certain cash payments following the closing of the Merger pursuant to the CVR Agreement;

 

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Homology’s board of directors’ review of the business, strategy, financial position and prospects of Q32 and, in that context, the potential for Q32’s clinical development pipeline to generate substantial long-term value for the combined company and its stockholders;

 

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the financial resources available to the combined company as a result of the Pre-Closing Financing and the fact that the Pre-Closing Financing will be completed at the same implied equity value of Q32 as provided for pursuant to the Merger Agreement, as well as the possibility that the combined company would be able to take advantage of the potential benefits resulting from the Homology public company structure to raise additional funds in the future, if necessary;

 

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Homology’s board of directors’ view, following a review with Homology’s management and a scientific consultant of Q32’s current development plans, of the likelihood that the combined company would possess sufficient cash resources at the closing of the Merger to fund development of Q32’s pipeline through upcoming value inflection points;

 

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Homology’s board of directors’ view that the combined company is expected to be led by (i) a highly experienced and accomplished senior management team from Q32, many of whom have extensive experience in drug development, and (ii) a board of directors with representation from each of the current boards of directors of Homology and Q32; and

 

  •  

the financial presentation and opinion of TD Cowen, dated November 15, 2023, to Homology’s board of directors as to the fairness, from a financial point of view and as of the date of such opinion, to Homology of the Q32 Equity Value provided for pursuant to the Merger Agreement, which opinion was based on and subject to the various assumptions made, procedures followed, matters considered and limitations and qualifications on the review undertaken by TD Cowen set forth in such opinion as more fully described under the heading “The Merger—Opinion of Homology’s Financial Advisor.”

Homology’s board of directors also reviewed the terms of the Merger Agreement and associated transactions, including:

 

  •  

the calculation of the exchange ratio, closing net cash and the estimated number of shares of Homology common stock to be issued in the Merger, including that the valuation of Homology under the Merger Agreement would be reduced only to the extent that Homology’s closing net cash is less than $59.5 million, and that the valuation of Homology under the Merger Agreement would be increased to the extent Homology’s closing net cash exceeds $60.5 million;

 

  •  

the Q32 Pre-Closing Financing contemplated by the subscription agreement and the limited number and nature of the conditions to the obligation of the proposed investors in Q32 to consummate the Q32 Pre-Closing Financing contemplated by the subscription agreement and that Q32’s receipt of $42.0 million pursuant to the subscription agreement is a closing condition under the Merger Agreement;

 

  •  

the limited number and nature of the conditions to Q32’s obligation to consummate the Merger and the limited risk of non-satisfaction of such conditions as well as the likelihood that the Merger will be consummated on a timely basis, as more fully described below under the caption “The Merger Agreement—Conditions to the Completion of the Merger” in this proxy statement/prospectus;

 

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  •  

the rights of Homology under the Merger Agreement to consider certain unsolicited Acquisition Proposals under certain circumstances should Homology receive a Superior Offer, as more fully described below under the caption “The Merger Agreement—Non-Solicitation” in this proxy statement/prospectus;

 

  •  

the right of each party to terminate the Merger Agreement and the reasonableness of the potential termination fees of $2.4 million, in the case of the fee payable by Homology, and $5.85 million, in the case of the fee payable by Q32, which could become payable by either Homology or Q32, as applicable, to the other party if the Merger Agreement is terminated in certain circumstances, as more fully described below under the caption “The Merger Agreement—Termination and Termination Fees” in this proxy statement/prospectus;

 

  •  

the support agreements, pursuant to which certain stockholders of Homology and Q32 agreed, solely in their capacity as stockholders, to vote all of their shares of Homology or Q32 capital stock, as applicable, in favor of adoption of the Merger Agreement and the transactions contemplated thereby, as more fully described below under the caption “Agreements Related to the Merger—Support Agreements” in this proxy statement/prospectus;

 

  •  

the lock-up agreements, pursuant to which certain stockholders of Homology and Q32 agreed, subject to certain exceptions and solely in their capacity as stockholders, to refrain from transferring or disposing of Homology common stock for a period of 180 days after the completion of the Merger, as more fully described below under the caption “Agreements Related to the Merger—Lock-Up Agreements” in this proxy statement/prospectus;

 

  •  

the potential ability of Homology’s stockholders to realize value for the sale of the assets and rights under the CVR Agreement, as more fully described below under the caption “Agreements Related to the Merger—Contingent Value Rights Agreement” in this proxy statement/prospectus;

 

  •  

the agreement of Q32 to provide written consent of its stockholders necessary to adopt the Merger Agreement thereby approving the Merger and related transactions; and

 

  •  

the belief that the terms of the Merger Agreement, including the parties’ representations, warranties and covenants, and the conditions to their respective obligations, are reasonable under the circumstances.

In the course of its deliberations, the Homology board of directors also considered a variety of risks and other countervailing factors related to entering into the Merger, including:

 

  •  

the risk that the potential benefits of the Merger may not be fully achieved, or may not be achieved within the expected timeframe;

 

  •  

the possibility that Homology’s stockholders may not approve the Merger proposals;

 

  •  

the $2.4 million termination fee payable to Q32 upon the occurrence of certain events and the potential effect of such termination fee in deterring other potential acquirers from proposing an alternative transaction that may be more advantageous to Homology stockholders;

 

  •  

the prohibition on Homology to solicit alternative acquisition proposals during the pendency of the Merger;

 

  •  

the substantial expenses to be incurred in connection with the Merger;

 

  •  

the possibility that Homology Net Cash, as more fully described below under the caption “The Merger Agreement—Calculation of Homology’s Net Cash” in this proxy statement/prospectus, may be lower at Closing that currently anticipated, which would reduce the ownership of Homology stockholders of the combined company;

 

  •  

the possible volatility of the trading price of the Homology common stock resulting from the announcement, pendency or completion of the Merger;

 

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  •  

the scientific, technical, regulatory and other risks and uncertainties associated with development and commercialization of Q32’s product candidates;

 

  •  

the risk that, while the Merger is expected to be completed, there is no assurance that all the conditions to the parties’ obligations to complete the Merger will be satisfied or waived, and the risk that the Merger might not be consummated in a timely manner or at all;

 

  •  

the risk to the business of Homology and its operations and financial results in the event that the Merger is not consummated, including the potential adverse effect of the public announcement of a failure to complete the Merger on the reputation of Homology;

 

  •  

the strategic direction of the combined company following the completion of the Merger, which will be determined by a board of directors of which the members of the current Homology board of directors will comprise a minority;

 

  •  

the possibility that Homology’s stockholders may not receive any value under the CVR Agreement, including if the Legacy Assets are not sold prior to the 18-month anniversary of the Closing Date; and

 

  •  

various other risks associated with the combined organization and the Merger, including those described in the section titled “Risk Factors” in this proxy statement/prospectus.

The foregoing information and factors considered by Homology’s board of directors are not intended to be exhaustive but are believed to include certain material factors considered by Homology’s board of directors. In view of the wide variety of factors considered in connection with its evaluation of the Merger and the complexity of these matters, Homology’s board of directors did not find it useful, and did not attempt, to quantify, rank or otherwise assign relative weights to these factors. In considering the factors described above, individual members of Homology’s board of directors may have given different weight to different factors. Homology’s board of directors conducted an overall review of the factors described above and considered the factors overall to be favorable to, and to support, its determination.

Q32 Reasons for the Merger

In the course of reaching its decision to approve the Merger, the Q32 board of directors held numerous meetings, consulted with Q32’s senior management, its financial advisors and legal counsel, and considered a wide variety of factors, including, among others, the following material factors (which factors are not necessarily presented in any order of relative importance):

 

  •  

the Merger will provide Q32’s current stockholders with greater liquidity by owning publicly-traded stock, and expanding the range of investors potentially available as a public company, compared to the investors Q32 could otherwise gain access to if it continued to operate as a privately-held company;

 

  •  

the historical and current information concerning Q32’s business, including its financial performance and condition, operations, management, clinical and preclinical data;

 

  •  

the competitive nature of the industry in which Q32 operates;

 

  •  

the Q32 board of directors’ belief that no alternatives to the Merger were reasonably likely to create greater value for Q32’s stockholders, after reviewing the various financing and other strategic options to enhance stockholder value that were considered by the Q32 board of directors;

 

  •  

the projected financial position, operations, management structure, geographic locations, operating plans, cash burn rate and financial projections of the combined company, including the expected cash resources of the combined organization (including the ability to support the combined company’s current and planned clinical trials and operations);

 

  •  

the availability of appraisal rights under the DGCL to holders of Q32’s capital stock who comply with the required procedures under the DGCL, which allow such holders to seek appraisal of the fair value of their shares of Q32 capital stock as determined by the Delaware Court of Chancery;

 

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  •  

the terms and conditions of the Merger Agreement, including the following:

 

  •  

the determination that the expected relative percentage ownership of Homology’s stockholders and Q32’s stockholders in the combined organization was appropriate, based on the Q32 board of directors’ judgment and assessment of the approximate valuations of Homology and Q32;

 

  •  

the expectation that the Merger should qualify as a “reorganization” within the meaning of Section 368(a) of the Code for U.S. federal income tax purposes, with the result that the Q32 stockholders that exchange their Q32 common stock for Homology common stock in the Merger should generally not recognize taxable gain or loss for U.S. federal income tax purposes on such exchange;

 

  •  

the limited number and nature of the conditions of the obligation of Homology to consummate the Merger;

 

  •  

the rights of Q32 under the Merger Agreement to consider certain unsolicited acquisition proposals under certain circumstances should Q32 receive a superior proposal;

 

  •  

the conclusion of the Q32 board of directors that the potential termination fee of $5,850,000, payable by Q32 to Homology, and the circumstances when such fee may be payable, were reasonable;

 

  •  

the conclusion of the Q32 board of directors that the potential termination fee of $2,400,000, payable by Homology to Q32, and the circumstances when such fee may be payable, were reasonable;

 

  •  

the belief that the other terms of the Merger Agreement, including the parties’ representations, warranties and covenants, and the conditions to their respective obligations, were reasonable in light of the entire transaction;

 

  •  

the shares of Homology’s common stock issued to Q32’s stockholders in the Merger will be registered on a Form S-4 registration statement and will become freely tradable for Q32’s stockholders who are not affiliates of Q32 and who are not parties to lock-up agreements;

 

  •  

the support agreements, pursuant to which certain directors, officers and stockholders of Q32 and Homology, respectively, have agreed, solely in their capacity as stockholders of Q32 and Homology, respectively, to vote all of their shares of Q32 capital stock or Homology common stock in favor of the issuance of shares of Homology to stockholders of Q32;

 

  •  

the ability to obtain a Nasdaq listing and the change of the combined organization’s name to Q32 Bio Inc. upon the closing of the Merger; and

 

  •  

the likelihood that the Merger will be consummated on a timely basis.

The Q32 board of directors also considered a number of uncertainties and risks in its deliberations concerning the Merger and the other transactions contemplated by the Merger Agreement, including the following:

 

  •  

the possibility that the Merger might not be completed for a variety of reasons, such as the failure of Homology to obtain the required stockholder vote, and the potential adverse effect of the public announcement of the Merger on the reputation of Q32 and the ability of Q32 to obtain financing in the future in the event the Merger is not completed;

 

  •  

the risk that future sales of common stock by existing Homology stockholders may cause the price of Homology common stock to fall, thus reducing the potential value of Homology common stock received by Q32 stockholders following the Merger;

 

  •  

the exchange ratio used to establish the number of shares of Homology’s common stock to be issued to Q32’s stockholders in the Merger is fixed, except for adjustments due to the parties’ respective cash balances and outstanding capital stock at closing, and thus the relative percentage ownership of Homology’s stockholders and Q32’s stockholders in the combined organization immediately following the completion of the Merger is similarly fixed;

 

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  •  

the termination fee of $5,850,000, payable by Q32 to Homology upon the occurrence of certain events, and the potential effect of such termination fee in deterring other potential acquirers from proposing an alternative transaction that may be more advantageous to Q32’s stockholders;

 

  •  

the potential reduction of Homology’s net cash prior to the closing;

 

  •  

the possibility that Homology could, under certain circumstances, consider unsolicited acquisition proposals if superior to the Merger or change its recommendation to approve the Merger upon certain events;

 

  •  

the risk that the Merger might not be consummated in a timely manner or at all;

 

  •  

the costs involved in connection with completing the Merger, the time and effort of Q32 senior management required to complete the Merger, the related disruptions or potential disruptions to Q32’s business operations and future prospects, including its relationships with its employees, suppliers and partners and others that do business or may do business in the future with Q32, and related administrative challenges associated with combining the companies;

 

  •  

the additional expenses and obligations to which Q32’s business will be subject following the Merger that Q32 has not previously been subject to, including pursuant to the CVR Agreement, and the operational changes to Q32’s business, in each case that may result from being a public company;

 

  •  

the fact that the representations and warranties in the Merger Agreement do not survive the closing of the Merger and the potential risk of liabilities that may arise post-closing; and

 

  •  

various other risks associated with the combined organization and the Merger, including the risks described in the section entitled “Risk Factors” in this proxy statement/prospectus.

The foregoing information is not intended to be exhaustive, but summarizes the material factors considered by the Q32 board of directors in its consideration of the Merger Agreement and the transactions contemplated. The Q32 board of directors concluded that the benefits, advantages and opportunities of a potential transaction outweighed the uncertainties and risks described above. After considering these and other factors, the Q32 board of directors unanimously approved the Merger Agreement, the Merger and the other transactions contemplated by the Merger Agreement.

Opinion of Homology’s Financial Advisor

Homology has engaged TD Cowen as its financial advisor in connection with the Merger. In connection with this engagement, the Homology board of directors requested that TD Cowen evaluate the fairness, from a financial point of view, to Homology of the Q32 Equity Value provided for pursuant to the Merger Agreement.

At a meeting of the Homology board of directors held on November 15, 2023, TD Cowen reviewed with the Homology board of directors TD Cowen’s financial analysis of the Q32 Equity Value and delivered an oral opinion, confirmed by delivery of a written opinion dated November 15, 2023, to the Homology board of directors to the effect that, based on and subject to the various assumptions made, procedures followed, matters considered and limitations and qualifications on the review undertaken by TD Cowen as set forth in such opinion, as of November 15, 2023, the Q32 Equity Value provided for pursuant to the Merger Agreement was fair, from a financial point of view, to Homology. For purposes of TD Cowen’s financial analyses and opinion, the term “Q32 Equity Value” refers to the equity value of $195 million ascribed to Q32 pursuant to the Merger Agreement. The full text of TD Cowen’s written opinion, dated November 15, 2023, is attached as Annex H to this proxy statement/prospectus and is incorporated herein by reference. The summary of TD Cowen’s written opinion set forth herein is qualified in its entirety by reference to the full text of such opinion. TD Cowen’s analyses and opinion were prepared for and addressed to the Homology board of directors and were directed only to the fairness, from a financial point of view, to Homology of the Q32 Equity Value. TD Cowen’s opinion did not in any manner address the value of the Homology CVRs, Homology’s underlying business decision to effect the Merger or related transactions or the relative merits of the

 

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Merger or related transactions as compared to other business strategies or transactions that might be available to Homology. The Q32 Equity Value was determined through negotiations between Homology and Q32 and TD Cowen’s opinion does not constitute a recommendation to any securityholder or any other person as to how to vote or act with respect to the Merger, any related transactions or otherwise.

In connection with its opinion, TD Cowen reviewed and considered such financial and other matters as it deemed relevant, including, among other things:

 

  •  

a final form, provided to TD Cowen on November 15, 2023, of the Merger Agreement;

 

  •  

certain publicly available financial and other information for Homology and certain other relevant financial and operating data furnished to TD Cowen by the management of Homology;

 

  •  

certain financial and other information for Q32 and certain other relevant financial and operating data furnished to TD Cowen by the managements of Homology and Q32;

 

  •  

certain internal financial analyses, probability-adjusted financial forecasts, reports and other information concerning Q32 prepared by the management of Q32 as adjusted by the management of Homology (as adjusted, referred to in this section as the “Q32 forecasts”);

 

  •  

discussions TD Cowen had with certain members of the managements of Homology and Q32, as the case may be, concerning the historical and current business operations, financial conditions and prospects of Homology and Q32 and such other matters that TD Cowen deemed relevant;

 

  •  

certain operating results of, and financial information for, Q32 as compared to similar information for certain publicly traded companies that TD Cowen deemed relevant; and

 

  •  

such other information, financial studies, analyses and investigations and such other factors that TD Cowen deemed relevant for the purposes of its opinion.

In conducting its review and arriving at its opinion, TD Cowen, at the direction of the Homology board of directors, assumed and relied, without independent investigation, upon the accuracy and completeness of all financial and other information provided to TD Cowen by Homology and Q32 or which was publicly available or was otherwise reviewed by TD Cowen. TD Cowen did not undertake any responsibility for the accuracy, completeness or reasonableness of, or independent verification of, such information. TD Cowen relied upon the respective representations of Homology and Q32 that all information provided to TD Cowen by Homology and Q32 was accurate and complete in all material respects and TD Cowen expressly disclaimed any undertaking or obligation to advise any person of any change in any fact or matter affecting its opinion of which TD Cowen becomes aware after the date of TD Cowen’s opinion.

TD Cowen was advised that, given that Homology’s assets and liabilities are comprised of cash (net of liabilities) and the Homology Legacy Assets (which currently are contemplated to be sold) and that Homology was not expected to have any continuing business operations on a standalone basis other than those incidental to Homology’s status as a publicly traded company, the management of Homology had not prepared financial forecasts relating to Homology. Accordingly, TD Cowen did not perform a financial analysis of Homology or the CVRs. TD Cowen assumed that, when delivered as contemplated by the Merger Agreement, additional financial statements and other financial information relating to Q32 would not reflect any information that would be meaningful in any respect to TD Cowen’s analyses or opinion. TD Cowen further assumed, at the direction of the Homology board of directors, that the Q32 forecasts (as adjusted by the management of Homology) were reasonably prepared by the managements of Homology and Q32, as the case may be, on bases reflecting the best currently available estimates and good faith judgments of such managements as to the future performance of Q32 and the other matters covered thereby, and that such Q32 forecasts utilized in TD Cowen’s analyses provided a reasonable basis for TD Cowen’s opinion. TD Cowen relied on the assessments of the managements of Homology and Q32 as to, among other things, (i) the product pipeline, future products, technology and

 

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intellectual property of Q32, including the viability of and risks associated with such product pipeline, future products, technology and intellectual property, and (ii) the terms of the Pre-Closing Financing, including with respect to the timing, amount, valuation and other terms involved and potential impact thereof. TD Cowen assumed that there would be no developments with respect to any such matters that would have an adverse effect on Q32, Homology, the Merger or related transactions (including the contemplated benefits thereof) or that otherwise would be meaningful in any respect to TD Cowen’s analyses or opinion. TD Cowen expressed no opinion as to the Q32 forecasts or the assumptions on which they were based.

In addition, TD Cowen assumed that there had been no material changes in the assets, liabilities, financial condition, results of operations, businesses or prospects of Q32 or Homology since the dates of the last financial statements made available to TD Cowen. TD Cowen did not make or obtain any independent evaluations, valuations or appraisals of the assets or liabilities (contingent, accrued, derivative, off-balance sheet or otherwise) of Q32, Homology or any other entity, nor was TD Cowen furnished with such materials. TD Cowen did not conduct nor did TD Cowen assume any obligation to conduct any physical inspection of the properties or facilities of Q32, Homology or any other entity. TD Cowen also did not evaluate the solvency or fair value of Q32, Homology or any other entity under any state, federal or foreign laws relating to bankruptcy, insolvency or similar matters. In addition, TD Cowen did not undertake an independent evaluation of any actual or potential litigation, settlements, governmental or regulatory proceedings or investigations, possible unasserted claims or other contingent liabilities to which Q32, Homology or any other entity may be a party or subject. TD Cowen assumed that the Merger would qualify for the intended tax treatment contemplated by the Merger Agreement. TD Cowen’s opinion did not address any legal, tax, accounting or regulatory matters related to the Merger Agreement, the Merger or any related transactions, as to which TD Cowen assumed that Homology and the Homology board of directors received such advice from legal, tax, accounting and regulatory advisors as each determined appropriate.

TD Cowen’s opinion addressed only the fairness of the Q32 Equity Value, from a financial point of view, to Homology. TD Cowen expressed no view as to any related transactions (including, without limitation, the Pre-Closing Financing), the CVRs or any other aspect or implication of the Merger, including, without limitation, any support or lock-up agreements, subscription agreements or any other agreement, arrangement or understanding entered into in connection with the Merger, any related transactions or otherwise. TD Cowen’s opinion was necessarily based upon economic and market conditions and other circumstances as they existed and could be evaluated by TD Cowen on the date of such opinion. It should be understood that although subsequent developments may affect TD Cowen’s opinion, TD Cowen does not have any obligation to update, revise or reaffirm its opinion and TD Cowen expressly disclaims any responsibility to do so.

TD Cowen did not consider any potential legislative or regulatory changes currently being considered or recently enacted by the United States or any foreign government, or any domestic or foreign regulatory body, or any changes in accounting methods or generally accepted accounting principles that may be adopted by the SEC, the Financial Accounting Standards Board, or any similar foreign regulatory body or board.

For purposes of rendering its opinion, TD Cowen assumed in all respects material to its analyses that the representations and warranties of each party contained in the Merger Agreement were true and correct, that each party would perform all of the covenants and agreements required to be performed by it under the Merger Agreement and that all conditions to the consummation of the Merger and related transactions would be satisfied without waiver thereof. TD Cowen also assumed that the executed form of the Merger Agreement would be substantially similar to the final form reviewed by TD Cowen. TD Cowen further assumed that all governmental, regulatory and other consents and approvals contemplated by the Merger Agreement would be obtained and that in the course of obtaining any of those consents no restrictions would be imposed or waivers made that would have an adverse effect on Q32, Homology, the Merger or related transactions (including the contemplated benefits thereof). In addition, TD Cowen assumed that the Merger and related transactions would be consummated in a manner that complies with the applicable provisions of the Securities Act, the Exchange Act and all other applicable state or federal statutes, rules and regulations.

 

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It was understood that TD Cowen’s opinion was intended for the benefit and use of the Homology board of directors (in its capacity as such) in its evaluation of the Q32 Equity Value. TD Cowen’s opinion did not and does not constitute a recommendation to the Homology board of directors, any securityholder or any other person as to how to vote or act with respect to the Merger, any related transactions or otherwise. TD Cowen expressed no opinion as to the actual value, price or trading range of any securities of Homology (including Homology common stock and the CVRs) or Q32 (including Q32 common stock, Q32 preferred stock and Q32 convertible notes) upon or following announcement or consummation of the Merger and related transactions. TD Cowen was not requested to opine as to, and its opinion did not in any manner address, Homology’s underlying business decision to effect the Merger or related transactions or the relative merits of the Merger or related transactions as compared to other business strategies or transactions that might be available to Homology, including a liquidation of Homology. In addition, TD Cowen was not requested to opine as to, and its opinion did not in any manner address, (i) the fairness of the amount or nature of the compensation to the officers, directors or employees, or class of such persons, of any parties to the Merger or any related transactions relative to the Q32 Equity Value or otherwise or (ii) the fairness of the Merger, any related transactions or the Q32 Equity Value to the holders of any class of securities, creditors or other constituencies of Homology or Q32.

Financial Analyses

The summary of the financial analyses described below under this heading “—Financial Analyses” is a summary of the material financial analyses performed by TD Cowen to arrive at its opinion. Some of the summaries of TD Cowen’s financial analyses include information presented in tabular format. In order to fully understand the financial analyses, the tables must be read together with the text of each summary. The tables alone do not constitute a complete description of the financial analyses. Considering the data set forth in the tables without considering the full narrative description of the financial analyses, including the methodologies and assumptions underlying the analyses, could create a misleading or incomplete view of the financial analyses. TD Cowen performed certain procedures, including each of the financial analyses described below, and reviewed with the Homology board of directors certain assumptions on which such analyses were based and other factors, including the historical and projected financial results of Q32. Approximate implied equity value reference ranges derived from the financial analyses described below were rounded to the nearest $5 million.

Selected Publicly Traded Companies Analysis. TD Cowen reviewed selected financial and stock market information of Q32 and certain publicly traded clinical-stage biotechnology companies that TD Cowen considered generally relevant for purposes of analysis as companies addressing autoimmune and inflammatory diseases that lack profitability and are in early stage clinical trials (collectively, the “selected companies”). These companies were:

 

  •  

Alpine Immune Sciences, Inc.

 

  •  

AnaptysBio, Inc.

 

  •  

Apogee Therapeutics, Inc.

 

  •  

Dianthus Therapeutics, Inc.

 

  •  

Tourmaline Bio, Inc.

 

  •  

Zura Bio Limited

The financial data reviewed included estimated enterprise values, calculated as implied equity values based on closing stock prices on November 14, 2023 plus total debt and less cash and cash equivalents. Financial data of the selected companies were based on publicly available Wall Street research analysts’ estimates, public filings and other publicly available information. Financial data of Q32 was based on financial information concerning Q32 provided to TD Cowen .

The clinical stages of development observed for the selected companies ranged from Phase I to Phase II-ready and the overall low to high estimated enterprise values observed for the selected companies was

 

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approximately $(33) million to $473 million (with a 25th percentile of $17 million, a 75th percentile of $359 million and a median of $132 million). TD Cowen then selected the observed range of enterprise values (rounded) derived from the selected companies of $15 million to $360 million for Q32. This analysis indicated the following approximate implied equity value reference range for Q32, as compared to the Q32 Equity Value:

 

Approximate Implied Equity Value Reference Range    Q32 Equity Value

 

  

 

$45 million – $385 million      $195 million

Although the selected companies were used for comparison purposes, none of those companies is directly comparable to Q32. Accordingly, an analysis of the results of such a comparison is not purely mathematical, but instead involves complex considerations and judgments concerning differences in historical and projected financial and operating characteristics of the selected companies and other factors that could affect the public trading values of the selected companies.

Discounted Cash Flow Analysis. TD Cowen performed a discounted cash flow analysis of Q32 by calculating the estimated present value of the standalone unlevered, after-tax free cash flows that Q32 was forecasted to generate during the fiscal years ending December 31, 2024 through December 31, 2050 to capture Q32’s cash flows through profitability and loss of regulatory and patent exclusivity based on the Q32 forecasts (inclusive of the impact of Q32’s potential net operating loss carryforwards per the management of Q32 and probability-adjusted by the management of Homology to reflect potential risks associated with the clinical development of Q32’s products). For purposes of this analysis, stock-based compensation was treated as a cash expense. TD Cowen calculated implied terminal values for Q32 by applying to Q32’s estimated unlevered, after-tax free cash flows for the fiscal year ending December 31, 2050 a perpetuity growth rate of (33)% and a selected range of probability of success rates of 15% to 30%. The present values of the cash flows and terminal values were then calculated using a selected range of discount rates of 14% to 17%. This analysis indicated the following approximate implied equity value reference range for Q32, as compared to the Q32 Equity Value:

 

Approximate Implied Equity Value Reference Range    Q32 Equity Value

 

  

 

$155 million – $790 million      $195 million

Miscellaneous

The summary set forth above does not purport to be a complete description of all the analyses performed by TD Cowen. The preparation of a fairness opinion involves various determinations as to the most appropriate and relevant methods of financial analysis and the application of these methods to the particular circumstances and, therefore, such an opinion is not readily susceptible to partial analysis or summary description. TD Cowen did not attribute any particular weight to any analysis or factor considered by it, but rather made qualitative judgments as to the significance and relevance of each analysis and factor. Accordingly, notwithstanding the separate factors summarized above, TD Cowen believes that its analyses must be considered as a whole and that selecting portions of its analyses and the factors considered by it, without considering all analyses and factors, could create an incomplete view of the process underlying its opinion. In performing its analyses, TD Cowen made numerous assumptions with respect to industry performance, business and economic conditions and other matters, many of which are beyond the control of Homology and Q32. The analyses performed by TD Cowen are not necessarily indicative of actual values or future results, which may be significantly more or less favorable than suggested by such analyses. In addition, analyses relating to the value of businesses do not purport to be appraisals or to reflect the prices at which businesses or securities may actually be sold. Accordingly, such analyses and estimates are inherently subject to uncertainty and are based upon numerous factors or events beyond the control of the parties or their respective advisors. None of Homology, Q32, TD Cowen or any other person assumes responsibility if future results are materially different from those projected. The analyses performed by TD Cowen and its opinion were only one among many factors taken into consideration by the Homology board of directors in evaluating the Q32 Equity Value and should not be considered as determinative of the views of the Homology board of directors or Homology management with respect to the Merger, the Q32 Equity Value or otherwise.

 

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TD Cowen was selected by Homology to act as financial advisor to Homology in connection with the Merger because TD Cowen is a nationally recognized investment banking firm and because, as part of its investment banking business, TD Cowen is continually engaged in the valuation of businesses and their securities in connection with mergers and acquisitions, negotiated underwritings, secondary distributions of listed and unlisted securities, private placements and valuations for corporate and other purposes.

For its services as financial advisor to Homology in connection with the Merger, TD Cowen will receive from Homology an aggregate fee of $2.5 million, of which a portion was payable in connection with TD Cowen’s opinion and $1.85 million is payable contingent upon consummation of the Merger. In addition, Homology has agreed to reimburse TD Cowen’s expenses, including fees and expenses of counsel, and indemnify TD Cowen for certain liabilities, including liabilities under federal securities laws, that may arise out of TD Cowen’s engagement.

TD Cowen in the past has provided, currently is providing and in the future may provide financial advisory and/or investment banking services to Homology and/or its affiliates unrelated to the Merger, for which services TD Cowen has received and expects to receive compensation, including during the two years preceding the date of TD Cowen’s opinion having served as sales agent for certain at-the-market offerings of Homology common stock, for which services TD Cowen received during such two-year period aggregate fees of less than $50,000 from Homology. Although TD Cowen has not had a material relationship with Q32 during the two years preceding the date of TD Cowen’s opinion, TD Cowen in the future may provide services to Q32 and/or its affiliates and may receive compensation for the rendering of such services. In addition, in the ordinary course of its business, TD Cowen and its affiliates may actively trade the securities of Homology and/or its affiliates for their own account and for the accounts of their customers, and, accordingly, may at any time hold a long or short position in such securities. The issuance of TD Cowen’s opinion was approved by TD Cowen’s fairness opinion review committee.

Certain Unaudited Financial Projections for Q32

As a matter of course, Q32 does not publicly disclose long-term projections of future financial performance given among other things, the inherent difficulty of predicting financial performance for future periods and the possibility that the underlying assumptions and estimates may not be realized. However, in connection with the exploration of strategic opportunities described in this proxy statement/prospectus, Q32 management prepared certain non-public, unaudited projections of financial performance for Q32, which were provided to Homology and adjusted by Homology as further detailed in this section, or the Q32 Projections, based on its view of the prospects of Q32.

The Q32 Projections did not give effect to any changes or expenses as a result of the Merger or any other effects of the Merger or any impact should the Merger fail to be consummated. The Q32 Projections were prepared solely for internal use and are subjective in many respects. As a result, there can be no assurance that the forecasted results will be realized or that actual results will not be significantly higher or lower than estimated. The estimates and assumptions underlying the Q32 Projections involve judgments with respect to, among other things, future economic, competitive, regulatory and financial market conditions that may not materialize and are inherently subject to significant uncertainties and contingencies, all of which are difficult to predict and many of which are beyond Q32’s control. There can be no assurance that the Q32 Projections will be realized and actual results may vary materially from those shown. Neither Homology’s independent auditors, nor any other independent accountants, have compiled, examined, or performed any procedures with respect to the prospective financial information contained herein, nor have they expressed any opinion or any other form of assurance on such information or its achievability, and assume no responsibility for, and disclaim any association with, the prospective financial information.

The prospective financial information included in this proxy statement/prospectus was not prepared with a view toward public dissemination or compliance with published guidelines of the SEC or established by the

 

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American Institute of Certified Public Accountants for preparation and presentation of prospective financial information or generally accepted accounting principles, or GAAP, but, in the view of Q32 management, was prepared on a reasonable basis, reflected, at the time the prospective financial information was prepared, the best currently available estimates and judgments of Q32 management, and presented, to the best of Q32 management’s knowledge and belief at that time, the expected course of action and the expected future financial performance of Q32. However, this information is not fact and should not be relied upon as necessarily predictive of actual future results and readers of this proxy statement/prospectus are cautioned not to place undue reliance, if any, on the prospective financial information.

The Q32 Projections are included in this proxy statement/prospectus solely to give Homology’s and Q32’s stockholders access to certain long-term financial analyses and forecasts that were made available to Homology and its financial advisor, and is not included in this proxy statement/prospectus to influence a Homology stockholder’s decision whether to vote for the Merger Proposal or for any other purpose. The inclusion of the Q32 Projections in this proxy statement/prospectus does not constitute an admission or representation that the information is material. The inclusion of the Q32 Projections should not be regarded as an indication that Q32 and/or its affiliates, officers, directors, advisors or other representatives consider the Q32 Projections to be necessarily predictive of actual future events and this information should not be relied upon as such. None of Q32, Homology and/or their respective affiliates, officers, directors, advisors or other representatives gives any stockholder of Homology or Q32 any assurance that actual results will not differ materially from the Q32 Projections. The Q32 Projections do not take into account any circumstances, transactions or events occurring after the date on which they were prepared.

Certain of the measures included in the Q32 Projections may be considered non-GAAP financial measures. Non-GAAP financial measures should not be considered in isolation from, or as a substitute for, financial information presented in compliance with GAAP, and non-GAAP financial measures as used by Q32 may not be comparable to similarly titled amounts used by other companies.

Financial measures provided to a financial advisor are excluded from the definition of non-GAAP financial measures and therefore, are not subject to SEC rules regarding disclosures of non-GAAP financial measures, which would otherwise require a reconciliation of a non-GAAP financial measure to a GAAP financial measure. Reconciliations of non-GAAP financial measures were not relied upon by the Homology Board in connection with its consideration of the Merger or by TD Cowen for purposes of its financial analyses. Accordingly, Q32 has not provided a reconciliation of the non-GAAP financial measures included in the Q32 Projections.

For the foregoing and other reasons, readers of this proxy statement/prospectus are cautioned that the inclusion of a summary of the Q32 Projections in this proxy statement/prospectus should not be regarded as a representation or guarantee that the targets will be achieved nor that they should place undue reliance, if any, on the Q32 Projections. The Q32 Projections constitute forward-looking statements and are subject to risks and uncertainties that could cause actual results to differ materially from the projected results. See also “Cautionary Statement Concerning Forward-Looking Statements” in this proxy statement/prospectus. The Q32 Projections are also subject to many risks and uncertainties and you are urged to review the section entitled “Risk Factors” in this proxy statement/prospectus for a description of risk factors relating to the Merger and Q32’s business.

The projections of financial performance for Q32 prepared by Q32 are based on numerous variables and assumptions that were deemed reasonable as of the date on which such projections were finalized, including, among other things, the following material assumptions:

 

  •  

the material product revenue streams being net sales of Q32’s bempikibart for the treatment of atopic dermatitis and alopecia areata and ADX-097 for AAV induction and maintenance in the United States;

 

  •  

a 2028 launch for a product to treat atopic dermatitis and alopecia areata in the United States and a 2030 launch for both an AAV induction therapy product and an AAV maintenance therapy product in the United States;

 

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  •  

peak market penetration in the United States ranging from 10-25%;

 

  •  

loss of regulatory and patent exclusivity in 2044 in the United States for Q32’s bempikibart and ADX-097 product candidates;

 

  •  

revenues outside the United States based on 20% royalty;

 

  •  

tiered royalty payments to Bristol Myers Squibb with percentages ranging from mid-single digit to low-double digits; and

 

  •  

a tax rate of 25% and a projected federal net operating loss (NOL) balance of $127 million as of December 31, 2023.

Following discussions with Q32 management, Homology management made adjustments to the projections of financial performance for Q32 prepared by Q32. The material differences and reasons for such differences in the Q32 Projections, compared to the projections of financial performance for Q32 prepared by Q32 are: (i) Homology management applied a probability of success rate of 25%, reflecting the probability of Q32 being able to successfully develop, obtain marketing approval for, and commercialize its ADX-097 and ADX-914 product candidates, including achieving market acceptance and obtaining adequate insurance coverage, (ii) Homology management estimated annual capital expenditures equivalent to 3% of the change in Q32’s annual U.S. revenue, (iii) Homology management applied a 3.0% growth rate to stock-based compensation expense until 2040 and a decrease based on revenue after such date and (iv) Homology management estimated an annual change in working capital equal to 8% of the change in Q32’s annual U.S. revenue, or (i) through (iv) collectively, the Homology Adjustments. The Homology Board considered, among other things, the Q32 Projections as adjusted by the Homology Adjustments in its evaluation of the Merger and determined that the time period and revenue figures presented in the Q32 Projections as adjusted by the Homology Adjustments were reasonable based on, among other things, the anticipated time needed for development, regulatory approval and commercialization of Q32’s ADX-097 and ADX-914 product candidates and projected revenue for ADX-097 and ADX-914 products. In evaluating these factors, the Homology Board considered the early-stage of development of Q32’s ADX-097 and ADX-914 product candidates, the years-long process of development and regulatory review required for a biopharmaceutical product candidate to be approved, the potential market for adaptive and innate immune system modulators, and the expected loss of regulatory and patent exclusivity for such products based on current regulations.

The following table presents a summary of the Q32 Projections prepared by Q32 management, as adjusted by the Homology Adjustments made by Homology management.

 

($ in millions)    2024E     2025E     2026E     2027E     2028E     2029E     2030E      2031E      2032E      2033E      2034E      2035E      2036E      2037E  

Total Adjusted Revenue(1)

     —         —         —         —        $ 16      $ 62     $ 170      $ 332      $ 526      $ 699      $ 839      $ 954      $ 980      $ 1,003  

Gross Profit(2)

     —         —         —         —        $ 14      $ 52     $ 146      $ 286      $ 454      $ 603      $ 721      $ 820      $ 843      $ 863  

EBIT(3)

   ($ 71 )    ($ 84 )    ($ 83 )    ($ 119 )    ($ 98 )    ($ 15 )    $ 71      $ 205      $ 319      $ 414      $ 530      $ 603      $ 620      $ 635  

NOPAT(4)

   ($ 71 )    ($ 84 )    ($ 83 )    ($ 119 )    ($ 98 )    ($ 15 )    $ 67      $ 195      $ 303      $ 341      $ 398      $ 452      $ 465      $ 476  

Unlevered Free Cash Flow(5)

   ($ 71 )    ($ 84 )    ($ 83 )    ($ 121 )    ($ 102 )    ($ 25 )    $ 52      $ 177      $ 286      $ 326      $ 386      $ 447      $ 463      $ 478  

 

($ in millions)    2038E      2039E      2040E      2041E      2042E      2043E      2044E      2045E      2046E      2047E      2048E      2049E      2050E  

Total Adjusted Revenue(1)

   $ 966      $ 915      $ 844      $ 788      $ 737      $ 704      $ 549      $ 427      $ 317      $ 245      $ 189      $ 146      $ 113  

Gross Profit(2)

   $ 837      $ 800      $ 746      $ 704      $ 664      $ 639      $ 498      $ 387      $ 288      $ 223      $ 172      $ 133      $ 103  

EBIT(3)

   $ 617      $ 592      $ 554      $ 524      $ 496      $ 478      $ 372      $ 289      $ 215      $ 166      $ 129      $ 99      $ 77  

NOPAT(4)

   $ 463      $ 444      $ 415      $ 393      $ 372      $ 359      $ 279      $ 217      $ 162      $ 125      $ 96      $ 74      $ 57  

Unlevered Free Cash Flow(5)

   $ 468      $ 450      $ 421      $ 399      $ 376      $ 371      $ 292      $ 228      $ 170      $ 131      $ 101      $ 78      $ 67  

(1) Total Adjusted Revenue is a non-GAAP financial measure that reflects risk-adjusted revenue associated with product sales.

(2) Gross Profit is a non-GAAP financial measure that reflects Total Adjusted Revenue, less costs of goods sold and royalties owed by Homology on ADX-914.

 

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(3) EBIT is a non-GAAP financial measure defined as Gross Profit less research and development expense, general and administrative expense, sales and marketing expense, stock-based compensation expense and other expense.

(4) NOPAT is a non-GAAP financial measure defined as EBIT less taxes.

(5) Unlevered Free Cash Flow is a non-GAAP financial measure defined as EBIT less tax expense (if profitable), capital expenditures and change in net working capital.

Homology management was provided with Q32’s estimates of Q32 cash of $33 million and Q32 debt of $6 million as of September 2023 and this financial information, together with the Q32 Projections as adjusted by the Homology Adjustments made by Homology management, were provided by Homology to TD Cowen for TD Cowen’s use and reliance in connection with its financial analyses and opinion described above under “—Opinion of Homology’s Financial Advisor.” Financial Advisor,” Q32’s estimates of Q32 cash of $33 million and Q32 debt of $6 million as of September 30, 2023.

Interests of Homology Directors and Executive Officers in the Merger

In considering the recommendation of the Homology board of directors with respect to issuing shares of Homology common stock in the Merger and the other matters to be acted upon by the Homology stockholders at the Homology Special Meeting, Homology stockholders should be aware that the directors and executive officers of Homology have interests in the Merger that may be different from, or in addition to, the interests of Homology stockholders generally. These interests may present such directors and executive officers with actual or potential conflicts of interest, and these interests, to the extent material, are described below.

The Homology board of directors was aware of and considered these potential conflicts of interest, among other matters, in reaching its decision to approve the Merger Agreement and the Merger, and to recommend that the Homology stockholders approve the proposals to be presented to the stockholders for consideration at the Homology Special Meeting as contemplated in this proxy statement/prospectus.

Ownership Interests

As of November 30, 2023, Homology’s non-employee directors and executive officers beneficially owned, in the aggregate, approximately 10.2% of the shares of Homology common stock, excluding any shares of Homology common stock issuable upon exercise or settlement of stock options or restricted stock units held by such individuals. The affirmative vote of the holders of a majority in voting power of the votes cast affirmatively or negatively at the Homology Special Meeting by the holders entitled to vote thereon, assuming a quorum is present, is required for approval of the Stock Issuance Proposal, the Reverse Stock Split Proposal, the Stock Option and Incentive Plan Proposal, the ESPP Proposal and the Adjournment Proposal. Certain Homology stockholders have also entered into support agreements in connection with the Merger. For a more detailed discussion of the support agreements, please see the section titled “Agreements Related to the Merger—Support Agreements” in this proxy statement/prospectus.

Treatment of Homology Equity Awards

Homology Options

Each outstanding option to purchase shares of Homology common stock that has an exercise price per share that is less than the closing trading price of a share of Homology common stock on the last full trading date on which the Homology common stock is traded prior to the date on which the Effective Time occurs, which is referred to as a Homology ITM Option, will vest in full immediately prior to the Effective Time, including those Homology ITM Options held by Homology’s executive officers and non-employee directors. The number of shares of Homology common stock underlying such options and the exercise price of such options will be adjusted in accordance with Homology’s 2018 Incentive Award Plan or 2015 Stock Incentive Plan, as applicable,

 

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to reflect the proposed Reverse Stock Split, as described under “Proposal No. 3: Approval of the Amendment to the Restated Certificate of Incorporation of Homology Effecting the Reverse Stock Split—Principal Effects of the Reverse Stock Split—Equity Compensation Plans and Outstanding Equity-Based Awards” in this proxy statement/prospectus, and the issuance of the CVRs.

Homology estimates that the aggregate amount that would be payable, net of exercise price, to all persons who are or have been an executive officer or non-employee director of Homology since January 1, 2022 if they exercised their Homology ITM Options, whether vested or unvested, and immediately sold the Homology common stock acquired upon exercise is approximately $40,000, based on the average closing trading price of Homology common stock over the first five business days following the first public announcement of the transactions contemplated by the Merger Agreement.

The table below sets forth information regarding the options to purchase Homology common stock held as of November 30, 2023 by each person who is or has been during the period beginning on January 1, 2022 through the date of this proxy statement/prospectus, an executive officer or non-employee director of Homology. The number of shares of Homology common stock underlying such options and the exercise price of such options will be adjusted in accordance with Homology’s 2018 Incentive Award Plan or 2015 Stock Incentive Plan, as applicable, to reflect the proposed Reverse Stock Split, as described under “Proposal No. 3: Approval of the Amendment to the Restated Certificate of Incorporation of Homology Effecting the Reverse Stock Split—Principal Effects of the Reverse Stock Split—Equity Compensation Plans and Outstanding Equity-Based Awards” in this proxy statement/prospectus, and the issuance of the CVRs. Depending on when the Effective Time occurs, certain options shown in the table may vest in accordance with their terms prior to the Effective Time.

 

Name

   Number of
Vested
Options
(#)
     Value
of Vested
Options
($)(1)
     Number of
Unvested
Options
(#)
     Value of
Unvested
Options
($)(1)
 

Executive Officers

           

Albert Seymour, Ph.D. (2)

     598,373        —          649,545        —    

W. Bradford Smith (3)

     586,027        —          277,084        —    

Paul Alloway, Ph.D.

     243,040        —          219,960        —    

Michael Blum (4)

     205,440        —          148,960        —    

Julie Jordan, M.D. (5)

     83,144        —          —          —    

Charles Michaud, Jr.

     47,348        —          55,752        —    

 

Name

   Number of
Vested
Options
(#)
     Value
of Vested
Options
($)(1)
     Number of
Unvested
Options
(#)
     Value of
Unvested
Options
($)(1)
 

Non-Employee Directors

           

Arthur Tzianabos, Ph.D.

     1,955,579        39,882      301,585        —    

Steven Gillis, Ph.D.

     100,740        —          23,000        —    

Matthew R. Patterson

     101,690        —          23,000        —    

Jeffrey V. Poulton

     72,000        —          23,000        —    

Alise S. Reicin, M.D.

     85,160        —          23,000        —    

Mary Thistle

     100,740        —          23,000        —    

 

(1)

The estimated value is the excess, if any, of (i) $0.56, which is the average closing trading price of Homology common stock over the first five business days following the first public announcement of the transactions contemplated by the Merger Agreement on November 16, 2023, over (ii) the exercise price of the option, multiplied by the number of shares underlying the vested or unvested portion, as applicable, of the option as of November 30, 2023.

(2)

Dr. Seymour, Homology’s former President and Chief Executive Officer, terminated employment with Homology on November 17, 2023. Under Dr. Seymour’s separation agreement, among other things, no

 

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  options to purchase shares of Homology common stock vested on his termination date. The shares underlying such options and the value thereof, are included in the “Number of Vested Options” and “Value of Vested Options” columns in the table. The remaining unvested options and the value thereof, remain outstanding and eligible to vest in accordance with the separation agreement and are included in the “Number of Unvested Options” and “Value of Unvested Options” columns in the table.
(3)

Mr. Smith, Homology’s former Chief Financial and Business Officer and Treasurer, terminated employment with Homology on November 17, 2023. Under Mr. Smith’s separation agreement, no options to purchase shares of Homology common stock vested on his termination date. The shares underlying such options and the value thereof are included in the “Number of Vested Options” and “Value of Vested Options” column in the table. The remaining unvested options and the value thereof remain outstanding and eligible to vest in accordance with the separation agreement and are included in the “Number of Unvested Options” and “Value of Unvested Options” columns in the table.

(4)

Mr. Blum, Homology’s former Chief Commercial Officer, terminated employment with Homology on August 3, 2023, but continues to provide services to Homology under a consulting agreement, dated August 3, 2023.

(5)

Dr. Jordan, Homology’s former Chief Medical Officer, terminated employment with Homology on August 3, 2023.

Homology Restricted Stock Units

Each restricted stock unit award covering shares of Homology common stock, which is referred to as a Homology Restricted Stock Unit, that is outstanding and unvested will vest in full immediately prior to the Effective Time, and the holder of each unsettled Homology Restricted Stock Unit will receive immediately prior to the Effective Time, the number of shares of Homology common stock equal to the number of vested and unsettled shares of Homology common stock underlying such Homology Restricted Stock Unit, including those Homology Restricted Stock Units held by Homology’s executive officers. Each Homology Restricted Stock Unit will be adjusted in accordance with Homology’s 2018 Incentive Award Plan to reflect the issuance of the CVRs.

Homology estimates that the aggregate value of the shares of Homology common stock that would be payable to all persons who are or have been an executive officer or non-employee director of Homology since January 1, 2022 upon vesting and settlement of the Homology Restricted Stock Units is approximately $146,000. This amount was determined using a per share Homology stock price of $0.56, which is the average closing trading price of Homology common stock over the first five business days following the first public announcement of the transactions contemplated by the Merger Agreement.

The table below sets forth information regarding the Homology Restricted Stock Units held as of November 30, 2023 by each person who is or has been during the period beginning on January 1, 2022 and the date of this proxy statement/prospectus, an executive officer of Homology. Other than Dr. Tzianabos, Homology’s non-employee directors did not hold any Homology Restricted Stock Units as of such date. The Homology Restricted Stock Units will be adjusted in accordance with Homology’s 2018 Incentive Award Plan to reflect the proposed Reverse Stock Split, as described under “Proposal No. 3: Approval of the Amendment to the Restated Certificate of Incorporation of Homology Effecting the Reverse Stock Split—Principal Effects of the Reverse Stock Split—Equity Compensation Plans and Outstanding Equity-Based Awards” in this proxy statement/prospectus, and the issuance of the CVRs. Depending on when the Effective Time occurs, certain Homology Restricted Stock Units shown in the table may vest in accordance with their terms prior to the Effective Time.

 

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Name

   Unvested
Restricted
Stock
Units
(#)
     Value of
Unvested
Restricted
Stock
Units
($)(1)
 

Executive Officers

     

Albert Seymour, Ph.D. (2)

     91,516        51,249  

W. Bradford Smith (3)

     34,347        19,234  

Paul Alloway, Ph.D.

     42,140        23,598  

Michael Blum (4)

     29,770        16,671  

Julie Jordan, M.D. (5)

     —          —    

Charles Michaud, Jr.

     10,688        5,985  

Non-Employee Directors

     

Arthur Tzianabos, Ph.D.

     53,140        29,758  

 

(1)

The estimated value of each unvested Homology Restricted Stock Unit is $0.56, which is the average closing trading price of Homology common stock over the first five business days following the first public announcement of the transactions contemplated by the Merger Agreement on November 16, 2023.

(2)

Dr. Seymour, Homology’s former President and Chief Executive Officer, terminated employment with Homology on November 17, 2023. Under Dr. Seymour’s separation agreement, among other things, 41,354 Homology Restricted Stock Units vested on his termination date. His remaining unvested Homology Restricted Stock Units and the value thereof, remain outstanding and eligible to vest in accordance with the separation agreement and are included in the “Unvested Restricted Stock Units” and “Value of Unvested Restricted Stock Units” columns in the table.

(3)

Mr. Smith, Homology’s former Chief Financial and Business Officer and Treasurer, terminated employment with Homology on November 17, 2023. Under Mr. Smith’s separation agreement, among other things, 22,523 Homology Restricted Stock Units vested on his termination date. His remaining unvested Homology Restricted Stock Units and the value thereof remain outstanding and eligible to vest in accordance with the separation agreement and are included in the “Unvested Restricted Stock Units” and “Value of Unvested Restricted Stock Units” columns in the table.

(4)

Mr. Blum, Homology’s former Chief Commercial Officer, terminated employment with Homology on August 3, 2023, but continues to provide services to Homology under a consulting agreement, dated August 3, 2023.

(5)

Dr. Jordan, Homology’s former Chief Medical Officer, terminated employment with Homology on August 3, 2023 and does not hold any restricted stock units.

Homology Employee Stock Purchase Plan

Homology sponsors its 2018 Employee Stock Purchase Plan, which is referred to as the Homology ESPP, in which executive officers and other employees are eligible to participate. In accordance with the Merger Agreement, Homology’s board of directors has adopted resolutions (i) providing that (a) no offering periods or purchase periods will begin after or in addition to the offering period underway as of the date of the Merger Agreement under the Homology ESPP, or the Current Offering Period, (b) no payroll deductions or other contributions will be made or effected after the Current Offering Period, and (c) each Homology ESPP participant’s accumulated contributions under the Homology ESPP will be returned to the participant in accordance with the terms of the Homology ESPP and (ii) terminating the Current Offering Period.

Executive Employment Arrangements

Albert Seymour, Ph.D.

Homology’s board of directors terminated the employment of Dr. Seymour, effective as of November 17, 2023. Under the terms of his separation agreement, subject to his continued compliance with restrictive covenants (including a non-competition covenant), Dr. Seymour is entitled to receive (i) base salary continuation for a period of 12 months, (ii) payment of all bonuses earned but unpaid as of the date of termination, (iii) direct payment of or reimbursement for

 

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continued medical, dental or vision coverage pursuant to COBRA for up to 12 months, less the amount he would have had to pay to receive such coverage as an active employee based on the cost sharing levels in effect on his termination date, (iv) a lump-sum cash payment equal to $85,759.88, (v) a lump-sum cash payment equal to 50% of his target annual bonus for 2023, (vi) an extension of the post-termination exercise period for his vested options until the first anniversary of his termination date, provided that no options will remain outstanding past the expiration date of the award and each option will be subject to early termination in connection with a corporate transaction, including the Merger, and (vii) accelerated vesting of a prorated portion of the number of his service-vesting restricted stock units that are scheduled to vest on the first annual vesting date of the applicable award following the date of termination, with the proration determined by reference to the portion of the vesting year that has elapsed since the last annual vesting date of the applicable award (or since the grant date if no vesting has occurred), rounded down to the nearest whole restricted stock unit. If the Merger closes on or before August 16, 2024, then, in addition to the foregoing severance benefits, Dr. Seymour is entitled to receive (a) an amount in cash equal to 0.5 times his base salary, (b) an amount in cash equal to 25% of his target annual bonus for the year of termination, (c) direct payment of or reimbursement for continued medical, dental or vision coverage pursuant to COBRA for up to 6 months, less the amount he would have had to pay to receive such coverage as an active employee based on the cost sharing levels in effect on his termination date, (d) accelerated vesting of all unvested options and restricted stock units that vest solely based

on the passage of time, with any such awards that vest based on the attainment of performance-vesting conditions being governed by the terms of the applicable award agreement, (e) if he provides transition services from his termination until closing of the Merger to the reasonable satisfaction of Homology, a lump sum cash payment of $85,759.88, and (f) an extension until the first anniversary of his termination date of the post-termination exercise period for options that vest upon closing of the Merger, provided that no options will remain outstanding past the expiration date of the award and each option will be subject to early termination in connection with a corporate transaction, including the Merger.

W. Bradford Smith

Homology’s board of directors terminated the employment of Mr. Smith, effective as of November 17, 2023. Under the terms of his separation agreement, subject to his continued compliance with restrictive covenants (including a non-competition covenant), Mr. Smith is entitled to receive (i) base salary continuation for a period of 12 months, (ii) payment of all bonuses earned but unpaid as of the date of termination, (iii) direct payment of or reimbursement for continued medical, dental or vision coverage pursuant to COBRA for up to 12 months, less the amount he would have had to pay to receive such coverage as an active employee based on the cost sharing levels in effect on his termination date, (iv) a lump-sum cash payment equal to $69,345.14, (v) a lump-sum cash payment equal to 50% of his target annual bonus for 2023; (vi) an extension of the post-termination exercise period for his vested options until the first anniversary of his termination date, provided that no options will remain outstanding past the expiration date of the award and each option will be subject to early termination in connection with a corporate transaction, including the Merger, and (vii) accelerated vesting of a prorated portion of the number of his service-vesting restricted stock units that are scheduled to vest on the first annual vesting date of the applicable award following the date of termination, with the proration determined by reference to the portion of the vesting year that has elapsed since the last annual vesting date of the applicable award (or since the grant date if no vesting has occurred), rounded down to the nearest whole restricted stock unit. If the Merger closes on or before August 16, 2024, then, in addition to the foregoing severance benefits, Mr. Smith is entitled to receive (a) accelerated vesting of all unvested options and restricted stock units that vest solely based on the passage of time, with any such awards that vest based on the attainment of performance-vesting conditions being governed by the terms of the applicable award agreement, (b) if he provides transition services from his termination until closing of the Merger to the reasonable satisfaction of Homology, a lump sum cash payment of $69,345.14, and (c) an extension until the first anniversary of his termination date of the post-termination exercise period for options that vest upon closing of the Merger, provided that no options will remain outstanding past the expiration date of the award and each option will be subject to early termination in connection with a corporate transaction, including the Merger.

 

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Mr. Smith also entered into a consulting agreement with Homology following his termination of employment on November 17, 2023 under which he will provide consulting services related to his former duties with Homology in exchange for a monthly consulting fee of $4,564.50. The consulting agreement will expire in February 2024 unless earlier terminated as provided in the agreement.

Paul Alloway, Ph.D.

Under Dr. Alloway’s amended and restated agreement, entered into on November 16, 2023, he is entitled to (a) an annual base salary of $462,425, (b) a payment equal to 50% of his target annual bonus for 2023, subject to his continued employment through the payment date, or the Alloway Annual Bonus, and (c) a lump sum cash payment in an amount equal to his base salary for the number of days elapsed from July 27, 2023 through the closing of the Merger, subject to his continued employment and a maximum of seven months of base salary (i.e., a maximum of $269,747.92), or the Alloway Change in Control Bonus. If Homology terminates Dr. Alloway without “cause” or he resigns for “good reason,” subject to his timely executing a separation agreement, including a release of claims, and his continued compliance with restrictive covenants (including a non-competition covenant), he is entitled to receive (i) an amount in cash equal to his base salary, (ii) payment of the Alloway Annual Bonus if it is unpaid as of the date of termination, (iii) direct payment of or reimbursement for continued medical, dental or vision coverage pursuant to COBRA for up to 12 months, less the amount he would have had to pay to receive such coverage as an active employee based on the cost sharing levels in effect on his termination date, (iv) an extension of the post-termination exercise period for his vested and outstanding options until the first anniversary of his termination date, provided that no options will remain outstanding past the expiration date of the award and each option will be subject to early termination in connection with a corporate transaction, including the Merger, (v) accelerated vesting of a prorated portion of the number of his unvested service-vesting restricted stock units that are scheduled to vest on the first annual vesting date of the applicable award following the date of termination, with the proration determined by reference to the portion of the vesting year that has elapsed since the last annual vesting date of the applicable award (or since the grant date if no vesting has occurred) rounded down to the nearest whole restricted stock unit, (vi) if the termination is before the Merger closes, a lump sum cash payment of $115,606.25, or the Partial Alloway Change in Control Bonus, (vii) if the termination is before the Merger closes, the Merger closes on or before August 16, 2024 and he provides transition services from his termination until closing of the Merger to the reasonable satisfaction of Homology, the excess of the Alloway Change in Control Bonus (determined disregarding the continued service requirement) over the Partial Alloway Change in Control Bonus, and (viii) if the termination is on or during the 12 months following the date the Merger closes, (A) accelerated vesting of all unvested service-vesting equity or equity-based awards and (B) an extension of the post-termination exercise period for his options that vest upon the closing of the Merger until the first anniversary of his termination date; provided that no options will remain outstanding past the expiration date of the award and each option will be subject to early termination in connection with a corporate transaction, including the Merger.

Charles Michaud, Jr.

Under Mr. Michaud’s employment agreement, entered into on November 16, 2023, he is entitled to (a) an annual base salary of $313,308, (b) a payment equal to 50% of his target annual bonus for 2023, subject to his continued employment through the payment date, or the Michaud Annual Bonus, and (c) a lump sum cash payment in an amount equal to his base salary for the number of days elapsed from July 27, 2023 through the closing of the Merger, subject to his continued employment and a maximum of seven months of salary (i.e., a maximum of $182,763), or the Michaud Change in Control Bonus. If Homology terminates Mr. Michaud without “cause” or he resigns for “good reason,” subject to his timely execution of a separation agreement, including a release of claims, and his compliance with restrictive covenants (including a non-competition covenant), he is entitled to receive (i) an amount in cash equal to nine months of his base salary, (ii) payment of the Michaud Annual Bonus if it is unpaid as of the date of termination, (iii) direct payment of or reimbursement for continued medical, dental or vision coverage pursuant to COBRA for up to 9 months, less the amount he would have had to pay to receive such coverage as an active employee based on the cost sharing levels in effect on his termination

 

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date, (iv) an extension of the post-termination exercise period for his vested and outstanding options until the first anniversary of his termination date, provided that no options will remain outstanding past the expiration date of the award and each option will be subject to early termination in connection with a corporate transaction, including the Merger, (v) accelerated vesting of a prorated portion of the number of his unvested service-vesting restricted stock units that are scheduled to vest on the first annual vesting date of the applicable award following the date of termination, with the proration determined by reference to the portion of the vesting year that has elapsed since the last annual vesting date of the applicable award (or since the grant date if no vesting has occurred) rounded down to the nearest whole restricted stock unit, (vi) if the termination is before the Merger closes, a lump sum cash payment of $78,327.00, or the Partial Michaud Change in Control Bonus, (vii) if the termination is before the Merger closes, the Merger closes on or before August 16, 2024 and he provides transition services from his termination until closing of the Merger to the reasonable satisfaction of Homology, the excess of the Michaud Change in Control Bonus (determined disregarding the continued service requirement) over the Partial Michaud Change in Control Bonus, and (viii) if the termination is on or during the 12 months following the date the Merger closes, (A) accelerated vesting of all unvested service-vesting equity or equity-based awards and (B) an extension of the post-termination exercise period for his options that vest upon the closing of the Merger until the first anniversary of his termination date, provided that no options will remain outstanding past the expiration date of the award and each option will be subject to early termination in connection with a corporate transaction, including the Merger.

Michael Blum

Mr. Blum previously terminated employment with Homology, but continues to provide services to Homology under a consulting agreement, dated August 3, 2023. Under his consulting agreement, Mr. Blum provides consulting services related to his former duties with Homology in exchange for (i) a consulting fee of $350 per hour, (ii) continued vesting of his outstanding options during the consulting period, (iii) if Homology terminates the consulting period on or within 12 months following a change in control (including the Merger) for any reason other than due to his breach of the consulting agreement or his restrictive covenants, accelerated vesting of his outstanding options and restricted stock units, and (iv) an extension of the post-termination exercise period for his vested options until August 3, 2024. The consulting agreement will expire on August 3, 2024 unless earlier terminated as provided in the agreement.

Julie Jordan, M.D.

Dr. Jordan and previously terminated employment with Homology and is not entitled to receive compensatory payments in connection with the Merger. Under her separation agreement, Dr. Jordan’s vested options remain outstanding and may be exercised until August 3, 2024.

Director Position Following the Merger

Arthur Tzianabos, Ph.D. and Mary Thistle are currently directors of Homology and will each continue as a director of the combined company after the Effective Time.

Interests of Q32 Directors and Executive Officers in the Merger

In considering the recommendation of the Q32 board of directors with respect to approving the Merger, stockholders should be aware that certain members of Q32’s directors and executive officers have interests in the Merger that are different from, or in addition to, the interests of Q32 stockholders generally. These interests may present them with actual or potential conflicts of interest, and these interests, to the extent material, are described below.

The board of directors of Q32 was aware of these potential conflicts of interest and considered them, among other matters, in reaching its decision to approve the Merger Agreement and the Merger, and to recommend that the Q32 stockholders approve the Merger as contemplated by this proxy statement/prospectus.

 

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Ownership Interests

As of November 30, 2023, Q32’s non-employee directors and executive officers beneficially owned, in the aggregate, approximately 42.7% of the shares of Q32 capital stock, which for purposes of this subsection excludes any Q32 shares issuable upon exercise of Q32 stock options held by such individuals. Such shares of Q32 capital stock will be converted into shares of Homology common stock at the Effective Time. Each of Q32’s officers, directors and affiliated stockholders have also entered into a support agreement in connection with the Merger. For a more detailed discussion of the support agreements, please see the section titled “Agreements Related to the Merger—Support Agreements” in this proxy statement/prospectus.

Stock Options

Q32’s directors and executive officers currently hold options, subject to vesting, to purchase shares of Q32 common stock. At the Effective Time, each option to purchase shares of Q32 common stock outstanding immediately prior to the Effective Time under the Q32 Bio Inc. 2017 Stock Option Plan and Grant Plan, as amended, or the Q32 2017 Plan, will automatically be converted into an option to purchase shares of Homology common stock equal to the number of shares of Q32 common stock subject to such option multiplied by the exchange ratio formula in the Merger Agreement and rounding that result down to the nearest whole number of shares at a per share exercise price equal to the existing exercise price of such option multiplied by the exchange ratio formula in the Merger Agreement, rounded up to the nearest whole cent. Homology will assume the Q32 2017 Plan. All rights with respect to Q32 common stock subject to Q32 options assumed by Homology will be converted into rights with respect to Homology common stock. Any restrictions on the exercise of any Q32 option assumed by Homology will continue following the conversion and the term, exercisability, vesting schedules and other provisions of assumed Q32 options will generally remain unchanged.

The following table details the outstanding options held by Q32’s directors and executive officers as of November 30, 2023.

 

Executive Officers    Shares of
Common
Stock
Underlying
Options (#)
     Volume
Weighted
Average
Option
Exercise
Price ($)
 

Jodie Morrison (1)

     6,712,593        0.38  

Lee Kalowski

     352,017        0.82  

Jason Campagna

     2,201,213        0.35  

Shelia Violette

     1,824,005        0.31  

Non-Employee Directors

     

Jayson Punwani

     —          —    

David Grayzel

     —          —    

Mark Iwicki

     933,848        0.35  

Kathy LaPorte

     266,814        0.35  

Bill Lundberg

     231,875        0.20  

Isaac Manke

     —          —    

Diyong Xu

     —          —    

 

  (1)

Ms. Morrison commenced part-time employment with Q32 on September 8, 2022 and became a full-time employee on November 1, 2022.

Management Following the Merger

As described elsewhere in this proxy statement/prospectus, including in the section titled “Management Following the Merger,”                of Q32’s directors and all of Q32’s executive officers are expected to become the directors and executive officers, respectively, of the combined company upon the closing of the Merger, in

 

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connection with which they may enter into employment agreements comparable to those of applicable executive officers of a publicly traded company, as disclosed in greater detail under “Q32 Executive Compensation – Employment Agreements” below.

Indemnification and Insurance

For a discussion of the indemnification and insurance provisions related to the Q32 directors and officers under the Merger Agreement, please see the section titled “The Merger Agreement-Indemnification and Insurance for Directors and Officers” below.

Compensation Committee Interlocks and Insider Participation

In connection with the closing of the Merger, the combined company’s board of directors is expected to select members of the compensation committee. Each member of the compensation committee is expected to be a “non-employee” director within the meaning of Rule 16b-3 of the rules promulgated under the Exchange Act and independent within the meaning of the independent director guidelines of Nasdaq. None of the proposed combined company’s executive officers serves as a member of the board of directors or compensation committee of any entity that has one or more executive officers who is proposed to serve on the combined company’s board of directors or compensation committee following the completion of the Merger.

Non-Employee Director Compensation

During the fiscal year ended December 31, 2022, Q32 did not have a formal non-employee director compensation program; however, Q32 has entered into letter agreements with its independent, non-employee directors that provide for quarterly payments of $10,000 for Ms. LaPorte and Mr. Lundberg and $12,500 for Mr. Iwicki. No non-employee director received any equity grants in 2022. Following completion of the Merger, it is expected that the combined company will provide compensation to non-employee directors pursuant to a new non-employee director compensation policy that is expected to be adopted post-closing, and which will be designed to enable the combined company to attract and retain, on a long-term basis, highly qualified non-employee directors.

2024 Stock Option and Incentive Plan

On                 , 2024, Homology’s board of directors, subject to stockholder approval and the closing, adopted the 2024 Stock Option and Incentive Plan, or the 2024 Plan. If Homology’s stockholders approve the 2024 Plan, it will become effective upon the closing of the Merger. For a summary of the 2024 Plan, see Proposal No. 4 in this proxy statement/prospectus.

2024 Employee Stock Purchase Plan

On                 , 2024, Homology’s board of directors, subject to stockholder approval and the closing, adopted the 2024 Employee Stock Purchase Plan, or the 2024 ESPP. If Homology’s stockholders approve the 2024 ESPP, it will become effective upon the closing of the Merger. For a summary of the 2024 ESPP, see Proposal No. 5 in this proxy statement/prospectus.

Effective Time of the Merger

The Merger Agreement requires the parties to consummate the Merger no later than the second (2nd) business day after all of the conditions to the consummation of the Merger contained in the Merger Agreement are satisfied or waived, including the adoption of the Merger Agreement by the Q32 stockholders and the approval by the Homology stockholders of the issuance of Homology common stock and the other transactions proposed under the Merger Agreement, other than those conditions that by their nature are to be satisfied at the

 

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closing of the Merger. The Merger will become effective upon the filing of a certificate of merger with the Secretary of State of the State of Delaware or at such later time as is agreed by Homology and Q32 and specified in the certificate of merger. Neither Homology nor Q32 can predict the exact timing of the consummation of the Merger.

Regulatory Approvals

In the United States, Homology must comply with applicable federal and state securities laws and the rules and regulations of Nasdaq in connection with the issuance of shares of Homology common stock to Q32’s stockholders in connection with the transactions contemplated by the Merger Agreement and the filing of this proxy statement/prospectus with the SEC. Homology does not intend to seek any regulatory approval from antitrust authorities to consummate the transactions.

Anticipated Accounting Treatment

The Merger is expected to be treated by Homology as a reverse merger and will be accounted for as a reverse recapitalization in accordance with U.S. GAAP. For accounting purposes, Q32 is considered to be issuing stock for primarily cash and cash equivalents, short term investments, and other non-operating assets of Homology based on the terms of the Merger Agreement and other factors, including: (i) Q32’s stockholders will own a substantial majority of the voting rights of the combined company; (ii) Q32 will designate a majority (seven of nine) of the initial members of the board of directors of the combined company; (iii) Q32’s executive management team will become the management of the combined company; and (iv) the combined company will be named Q32 Bio Inc. and be headquartered in Waltham, Massachusetts. Accordingly the Merger is expected to be treated as the equivalent of Q32 issuing stock for primarily cash and cash equivalents, short-term investments and non-operating assets. The net assets of Homology will be recorded as of the acquisition date in the financial statements of Q32 and the reported operating results prior to the Merger will be those of Q32. See the “Unaudited Pro Forma Condensed Combined Financial Information” elsewhere in this proxy statement/prospectus for additional information.

Nasdaq Stock Market Listing

Shares of Homology common stock are currently listed on Nasdaq under the symbol “FIXX.” Homology has agreed to use commercially reasonable efforts, to the extent required by the rules and regulations of the Nasdaq, to cause the shares of Homology common stock being issued in the Merger to be approved for listing (subject to notice of issuance) on Nasdaq at or prior to the Effective Time and to assist Q32 in preparing and filing an initial listing application on Nasdaq.

In addition, under the Merger Agreement, each of Homology’s and Q32’s obligation to complete the Merger is subject to the satisfaction or waiver by each of the parties, at or prior to the Merger, of various conditions, including that the shares of Homology common stock to be issued in the Merger have been approved for listing (subject to official notice of issuance) on Nasdaq as of the closing of the Merger.

If the Nasdaq Listing Application is accepted, Q32 anticipates that the common stock of the combined company will be listed on Nasdaq following the closing of the Merger under the trading symbol “QTTB.” As of December 14, 2023, the closing stock price of Homology common stock was $                .

Appraisal Rights and Dissenters’ Rights

Under the DGCL, Homology stockholders are not entitled to appraisal rights in connection with the Merger.

Q32 stockholders are entitled to appraisal rights in connection with the Merger under Section 262 of the DGCL.

The discussion below is not a complete summary regarding Q32 stockholders’ appraisal rights under Delaware law and is qualified in its entirety by reference to the text of the relevant provisions of Delaware law,

 

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which are attached as Annex K. Stockholders intending to exercise appraisal rights should carefully review Annex K. Failure to follow precisely any of the statutory procedures set forth in Annex K may result in a termination or waiver of these rights. This summary does not constitute legal or other advice, nor does it constitute a recommendation that Q32 stockholders exercise their appraisal rights under Delaware law.

Under Section 262, where a merger is adopted by stockholders by written consent in lieu of a meeting of stockholders pursuant to Section 228 of the DGCL, either the constituent corporation before the effective date of such merger or the surviving corporation, within ten days after the effective date of such merger, must notify each stockholder of the constituent corporation entitled to appraisal rights of the approval of such merger, the effective date of such merger and that appraisal rights are available.

If the Merger is completed, within ten days after the effective date of the Merger, Q32 will notify its stockholders that the Merger has been approved, the effective date of the Merger and that appraisal rights are available to any stockholder who has not approved the Merger. Holders of shares of Q32 common stock who desire to exercise their appraisal rights must deliver a written demand for appraisal to Q32 within 20 days after the date of mailing of that notice, and that stockholder must not have delivered a written consent approving the Merger. A demand for appraisal must reasonably inform Q32 of the identity of the stockholder and that such stockholder intends thereby to demand appraisal of the shares of Q32 common stock held by such stockholder. Failure to deliver a written consent approving the Merger will not in and of itself constitute a written demand for appraisal satisfying the requirements of Section 262. All demands for appraisal should be addressed to Q32 Bio Inc., c/o Goodwin Procter LLP, 100 Northern Avenue, Boston, MA 02210, Attention: John T. Haggerty; Jacqueline Mercier; Tevia K. Pollard; Sarah Ashfaq, and should be executed by, or on behalf of, the record holder of shares of Q32 common stock. ALL DEMANDS MUST BE RECEIVED BY Q32 WITHIN 20 DAYS AFTER THE DATE Q32 MAILS A NOTICE TO ITS STOCKHOLDERS NOTIFYING THEM THAT THE MERGER HAS BEEN APPROVED, THE EFFECTIVE DATE OF THE MERGER AND THAT APPRAISAL RIGHTS ARE AVAILABLE TO ANY STOCKHOLDER WHO HAS NOT APPROVED THE MERGER.

If you fail to deliver a written demand for appraisal within the time period specified above, you will be entitled to receive the merger consideration for your shares of Q32 common stock as provided for in the Merger Agreement, but you will have no appraisal rights with respect to your shares of Q32 common stock.

To be effective, a demand for appraisal by a holder of shares of Q32 common stock must be made by, or in the name of, the registered stockholder, fully and correctly, as the stockholder’s name appears on the stockholder’s stock certificate(s). Beneficial owners who do not also hold the shares of record may not directly make appraisal demands to Q32. The beneficial owner must, in these cases, have the registered owner, such as a broker, bank or other custodian, submit the required demand in respect of those shares. If shares are owned of record in a fiduciary capacity, such as by a trustee, guardian or custodian, execution of a demand for appraisal should be made by or for the fiduciary; and if the shares are owned of record by more than one person, as in a joint tenancy or tenancy in common, the demand should be executed by or for all joint owners. An authorized agent, including an authorized agent for two or more joint owners, may execute the demand for appraisal for a stockholder of record; however, the agent must identify the record owner or owners and expressly disclose the fact that, in executing the demand, he or she is acting as agent for the record owner. A record owner, such as a broker, who holds shares as a custodian for others, may exercise the record owner’s right of appraisal with respect to the shares held for one or more beneficial owners, while not exercising this right for other beneficial owners. In that case, the written demand should state the number of shares as to which appraisal is sought. Where no number of shares is expressly mentioned, the demand will be presumed to cover all shares held in the name of the record owner. In addition, the stockholder must continuously hold the shares of record from the date of making the demand through the Effective Time.

If you hold your shares of Q32 common stock in a brokerage account or in other custodian form and you wish to exercise appraisal rights, you should consult with your bank, broker or other custodian to determine the appropriate procedures for the making of a demand for appraisal by the custodian.

 

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At any time within 60 days after the Effective Time, any stockholder who has demanded an appraisal, but has neither commenced an appraisal proceeding or joined an appraisal proceeding as a named party, has the right to withdraw such stockholder’s demand and accept the terms of the Merger by delivering a written withdrawal to Q32. If, following a demand for appraisal, you have withdrawn your demand for appraisal in accordance with Section 262, you will have the right to receive the merger consideration for your shares of Q32 common stock.

Within 120 days after the effective date of the Merger, any stockholder who has delivered a demand for appraisal in accordance with Section 262 will, upon written request to the surviving corporation, be entitled to receive a written statement setting forth the aggregate number of shares not voted in favor of the Merger Agreement and with respect to which demands for appraisal rights have been received and the aggregate number of holders of these shares. This written statement will be mailed to the requesting stockholder within ten days after the stockholder’s written request is received by the surviving corporation or within ten days after expiration of the period for delivery of demands for appraisal, whichever is later. Within 120 days after the effective date of the Merger, either the surviving corporation or any stockholder who has delivered a demand for appraisal in accordance with Section 262 may file a petition in the Delaware Court of Chancery demanding a determination of the fair value of the shares held by all such stockholders. Upon the filing of the petition by a stockholder, service of a copy of the petition must be made upon the surviving corporation. The surviving corporation has no obligation to file a petition in the Delaware Court of Chancery in the event there are dissenting stockholders, and Q32, which is expected to be the surviving corporation, has no present intent to file a petition in the Delaware Court of Chancery. Accordingly, the failure of a stockholder to file a petition within the period specified could nullify the stockholder’s previously written demand for appraisal.

If a petition for appraisal is duly filed by a stockholder and a copy of the petition is delivered to the surviving corporation, the surviving corporation will then be obligated, within 20 days after receiving service of a copy of the petition, to provide the Delaware Court of Chancery with a duly verified list containing the names and addresses of all stockholders who have demanded an appraisal of their shares and with whom agreements as to the value of their shares have not been reached by the surviving corporation. After notice to dissenting stockholders who demanded appraisal of their shares, the Delaware Court of Chancery is empowered to conduct a hearing upon the petition, and to determine those stockholders who have complied with Section 262 and who have become entitled to the appraisal rights provided thereby. The Delaware Court of Chancery may require the stockholders who have demanded appraisal for their shares to submit their stock certificates to the Register in Chancery for notation thereon of the pendency of the appraisal proceedings; and if any stockholder fails to comply with that direction, the Delaware Court of Chancery may dismiss the proceedings as to that stockholder.

After determination of the stockholders entitled to appraisal of their shares, the Delaware Court of Chancery will appraise the “fair value” of the shares owned by those stockholders. This value will be exclusive of any element of value arising from the accomplishment or expectation of the Merger, but may include a fair rate of interest, if any, upon the amount determined to be the fair value. When the value is determined, the Delaware Court of Chancery will direct the payment of the value, with interest thereon accrued during the pendency of the proceeding, if the Delaware Court of Chancery so determines, to the stockholders entitled to receive the same, upon surrender by the holders of the certificates representing those shares. At any time before the entry of judgment in the proceedings, the surviving corporation may pay to each stockholder entitled to appraisal an amount in cash, in which case interest shall accrue thereafter only upon the sum of (i) the difference, if any, between the amount so paid and the fair value of the shares subject to appraisal as determined by the Delaware Court of Chancery and (ii) interest theretofore accrued, unless paid at that time.

In determining fair value, and, if applicable, a fair rate of interest, the Delaware Court of Chancery is required to take into account all relevant factors. In Weinberger v. UOP, Inc., the Delaware Supreme Court discussed the factors that could be considered in determining fair value in an appraisal proceeding, stating that “proof of value by any techniques or methods which are generally considered acceptable in the financial community and otherwise admissible in court” should be considered, and that “fair price obviously requires consideration of all relevant factors involving the value of a company.”

 

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Section 262 provides that fair value is to be “exclusive of any element of value arising from the accomplishment or expectation of the merger.” In Cede & Co. v. Technicolor, Inc., the Delaware Supreme Court stated that this exclusion is a “narrow exclusion [that] does not encompass known elements of value,” but which rather applies only to the speculative elements of value arising from such accomplishment or expectation. In Weinberger, the Delaware Supreme Court construed Section 262 to mean that “elements of future value, including the nature of the enterprise, which are known or susceptible of proof as of the date of the merger and not the product of speculation, may be considered.”

You should be aware that the fair value of your shares as determined under Section 262 could be more than, the same as, or less than the value that you are entitled to receive under the terms of the Merger Agreement. An opinion of an investment banking firm as to the fairness, from a financial point of view, of the consideration payable in a merger is not an opinion as to, and does not in any manner address, fair value under Section 262.

Costs of the appraisal proceeding may be imposed upon the surviving corporation and the stockholders participating in the appraisal proceeding by the Delaware Court of Chancery as the Court deems equitable in the circumstances. Upon the application of a stockholder, the Delaware Court of Chancery may order all or a portion of the expenses incurred by any stockholder in connection with the appraisal proceeding, including, without limitation, reasonable attorneys’ fees and the fees and expenses of experts, to be charged pro rata against the value of all shares entitled to appraisal. In the absence of such a determination of assessment, each party bears its own expenses. Any stockholder who had demanded appraisal rights will not, after the Effective Time, be entitled to vote shares subject to that demand for any purpose or to receive payments of dividends or any other distribution with respect to those shares, other than with respect to payment as of a record date prior to the Effective Time; however, if no petition for appraisal is filed within 120 days after the Effective Time, or if the stockholder delivers a written withdrawal of his or her demand for appraisal and an acceptance of the terms of the Merger within 60 days after the Effective Time, then the right of that stockholder to appraisal will cease and that stockholder will be entitled to receive the merger consideration for shares of his or her Q32 common stock pursuant to the Merger Agreement. Any withdrawal of a demand for appraisal made more than 60 days after the Effective Time may only be made with the written approval of the surviving corporation. No appraisal proceeding in the Delaware Court of Chancery will be dismissed as to any stockholder without the approval of the court.

Failure to follow the steps required by Section 262 for perfecting appraisal rights may result in the loss of appraisal rights. In view of the complexity of Section 262, stockholders who may wish to dissent from the Merger and pursue appraisal rights should consult their legal advisors.

 

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THE MERGER AGREEMENT

The following is a summary of the material terms of the Merger Agreement. A copy of the Merger Agreement is attached to this proxy statement/prospectus as Annex A and is incorporated by reference into this proxy statement/prospectus. The Merger Agreement has been attached to this proxy statement/prospectus to provide you with information regarding its terms. It is not intended to provide any other factual information about Homology, Q32 or Merger Sub. The following description does not purport to be complete and is qualified in its entirety by reference to the Merger Agreement. You should refer to the full text of the Merger Agreement for details of the Merger and the terms and conditions of the Merger Agreement.

The Merger Agreement contains representations and warranties that Homology and Merger Sub, on the one hand, and Q32, on the other hand, have made to one another as of specific dates. These representations and warranties have been made for the benefit of the other parties to the Merger Agreement and may be intended not as statements of fact but rather as a way of allocating the risk to one of the parties if those statements prove to be incorrect. In addition, the assertions embodied in the representations and warranties are qualified by information in confidential disclosure schedules exchanged by the parties in connection with signing the Merger Agreement. While Homology and Q32 do not believe that these disclosure schedules contain information required to be publicly disclosed under the applicable securities laws, other than information that has already been so disclosed, the disclosure schedules do contain information that modifies, qualifies and creates exceptions to the representations and warranties set forth in the attached Merger Agreement. Accordingly, you should not rely on the representations and warranties as current characterizations of factual information about Homology or Q32, because they were made as of specific dates, may be intended merely as a risk allocation mechanism between Homology, Merger Sub and Q32 and are modified by the disclosure schedules.

Structure

Subject to the terms and conditions of the Merger Agreement, and subject to the applicable provisions of Delaware law, at the completion of the Merger, Merger Sub, a wholly-owned subsidiary of Homology formed by Homology in connection with the Merger, will merge with and into Q32, with Q32 surviving as a wholly-owned subsidiary of Homology.

Completion and Effectiveness of the Merger

The closing of the Merger will take place remotely no later than the second business day after all of the conditions precedent set forth in Article VI of the Merger Agreement have been satisfied or waived (other than those conditions that, by their nature, are to be satisfied at the closing of the Merger) or at such other time, date and place as Homology and Q32 may mutually agree in writing. Homology and Q32 are working to complete the Merger as quickly as practicable and expect that the Merger will be completed during the first quarter of 2024, subject to the approval of Homology’s stockholders. However, Homology and Q32 cannot predict the completion of the Merger or the exact timing of the completion of the Merger because it is subject to various conditions.

Merger Consideration

At the Effective Time (after giving effect to the Pre-Closing Financing), each share of Q32 common stock (excluding Q32 common stock issued in the Pre-Closing Financing) will be converted solely into the right to receive a number of shares of Homology common stock equal to the total number of Q32 Merger Shares described in the section titled “The Merger Agreement–Q32 Merger Shares” multiplied by the applicable Q32 stockholder’s percentage interest in Q32 as set forth on the Allocation Certificate required under the Merger Agreement. If any Q32 common stock outstanding immediately prior to the Effective Time is unvested or is subject to a repurchase option or a risk of forfeiture under any applicable agreement with Q32, then the shares of Homology common stock issued in exchange for such shares of Q32 common stock will to the same extent be unvested and subject to the same repurchase option or risk of forfeiture, and such shares of Homology common stock will be marked with appropriate legends.

 

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At the Effective Time, by virtue of the Merger, upon the terms and subject to the conditions set forth in the Merger Agreement, each share of Q32 common stock issued in the Pre-Closing Financing will be converted solely into the right to receive a number of shares of Homology common stock equal to the amount of the Pre-Closing Financing Merger Shares described in the section titled “The Merger Agreement–Pre-Closing Financing Merger Shares” multiplied by the percentage of the proceeds of the Pre-Closing Financing represented by the applicable stockholder’s investment in the Pre-Closing Financing, as set forth on the Allocation Certificate required under the Merger Agreement.

No fractional shares of Homology common stock will be issued in connection with the Merger, and no certificates or scrip for any such fractional shares will be issued, with no cash being paid for any fractional share eliminated by such rounding. Any fractional shares of Homology common stock resulting from the conversion of Q32 capital stock into the right to receive a number of Homology common stock a holder of Q32 common stock would otherwise be entitled to receive shall be aggregated together first prior to eliminating any remaining fractional share.

At the Effective Time, by virtue of the Merger, upon the terms and subject to the conditions set forth in the Merger Agreement, each share of common stock, $0.01 par value per share, of Merger Sub issued and outstanding immediately prior to the Effective Time will be converted into and exchanged for one validly issued, fully paid and nonassessable share of common stock, $0.0001 par value per share, of the combined company. If applicable, each stock certificate of Merger Sub evidencing ownership of any such shares shall, as of the Effective Time, evidence ownership of such shares of common stock of the combined company until presented for transfer or exchange.

All Q32 preferred stock will be converted into Q32 common stock as of immediately prior to the Effective Time in accordance with, and pursuant to the terms and conditions of, the organizational documents of Q32.

Allocation Certificate

In accordance with the Merger Agreement, prior to the closing date, Q32 will prepare and deliver to Homology a certificate, or the Allocation Certificate, setting forth (as of immediately prior to the Effective Time): (a) the name and address of each holder of Q32 Capital Stock, Q32 Options or Q32 Warrants, and the number and type of Q32 Capital Stock held as of the closing date for each such holder or, with respect to each Q32 Option or Q32 Warrant, the grant date of such Q32 Option or Q32 Warrant and the number of shares subject to such Q32 Option or Q32 Warrant, (b) the number of shares of Homology common stock to be issued to such holder pursuant to the Merger Agreement in respect of the Q32 Capital Stock held by such holder as of immediately prior to the Effective Time or, with respect to each Q32 Option or Q32 Warrant, the number of shares of Homology common stock to be subject to the applicable assumed option or assumed warrant as of immediately prior to the Effective Time following the conversion of such Q32 Option or Q32 Warrant into an assumed option or assumed warrant in accordance with the Merger Agreement, and (c) each investor in the Pre-Closing Financing, the total investment to be made by such investor in the Pre-Closing Financing, the percentage of the proceeds of the Pre-Closing Financing represented by such stockholder’s investment in the Pre-Closing Financing, and the number of shares of Homology common stock to be issued to such holder pursuant to the Merger Agreement.

Q32 Merger Shares

The formula to calculate Q32 Merger Shares, subject to the terms and conditions of the Merger Agreement, is the product determined by multiplying (i) the Post-Closing Homology Shares by (ii) the Q32 Allocation Percentage, in which:

 

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“Aggregate Valuation” means the sum of (A) the Q32 Equity Value, plus (B) the Homology Valuation, plus (C) the proceeds of the Pre-Closing Financing.

 

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“Homology Allocation Percentage” means the quotient (rounded to four decimal places) determined by dividing (A) the Homology Valuation by (B) the Aggregate Valuation.

 

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“Homology Equity Value” means $80,000,000.

 

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“Homology Outstanding Shares” means, subject to the terms and conditions of the Merger Agreement (including, without limitation, the effects of the Reverse Stock Split), the total number of shares of Homology common stock outstanding immediately prior to the Effective Time expressed on a fully-diluted basis, and assuming, without limitation or duplication, (A) the issuance of shares of Homology common stock in respect of all Homology ITM Options that will be outstanding as of immediately prior to the Effective Time calculated on a “treasury method” basis, (B) the settlement in shares of Homology common stock of Homology Restricted Stock Units outstanding as of immediately prior to the Effective Time on a net settlement basis as provided in the Merger Agreement and (C) the exclusion of shares of Homology common stock held by Homology as treasury stock or owned by Q32 or any of its subsidiaries or any subsidiary of Homology immediately prior to the Effective Time.

 

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“Homology Valuation” means (A) the Homology Equity Value minus (B) the Homology Net Cash Deficiency (if any) plus (C) the Homology Net Cash Surplus (if any).

 

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“Q32 Allocation Percentage” means the quotient (rounded to four decimal places) determined by dividing (A) the Q32 Equity Value by (B) the Aggregate Valuation.

 

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“Q32 Equity Value” means $195,000,000.

 

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“Homology Net Cash Deficiency” means, if Homology Net Cash is less than $59,500,000, then the amount, if any, that $60,000,000 exceeds the Homology Net Cash, calculated as of 12:01 am Eastern time on the closing date of the Merger; provided, however, any such calculation with respect to Taxes shall be calculated as of the end of the closing date of the Merger.

 

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“Post-Closing Homology Shares” means the quotient determined by dividing (A) the Homology Outstanding Shares by (B) the Homology Allocation Percentage.

 

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“Homology Net Cash Surplus” means, if Homology Net Cash is greater than $60,500,000, then the amount, if any, that the Homology Net Cash exceeds $60,000,000, calculated as of 12:01 am Eastern time on the closing date of the Merger; provided, however, any such calculation with respect to Taxes shall be calculated as of the end of the closing date of the Merger.

For the avoidance of doubt, the proceeds from the Pre-Closing Financing will not be included in the calculation or determination of the Homology Valuation or any component thereof.

Pre-Closing Financing Merger Shares

The formula to calculate the Pre-Closing Financing Merger Shares, subject to the terms and conditions of the Merger Agreement, is the product determined by multiplying (i) the Post-Closing Homology Shares by (ii) the Pre-Closing Financing Allocation Percentage, in which:

 

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“Post-Closing Homology Shares” is defined above.

 

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“Pre-Closing Financing Allocation Percentage” means the quotient (rounded to four decimal places) determined by dividing (A) the proceeds of the Pre-Closing Financing by (B) the Aggregate Valuation.

 

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“Aggregate Valuation” is defined above.

Calculation of Homology’s Net Cash

Pursuant to the terms of the Merger Agreement, Homology’s “Net Cash” means the sum (without duplication) of the following:

 

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Homology’s cash and cash equivalents and marketable securities determined, to the extent in accordance with GAAP, in a manner consistent with the manner in which such items were historically

 

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determined and in accordance with the financial statements (including any related notes) contained or incorporated by reference in the Homology balance sheet;

minus:

 

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fees and expenses of Homology incurred in connection with the transactions contemplated by the Merger Agreement, including for the avoidance of doubt, transaction expenses of Homology to the extent unpaid as of the closing of the Merger;

 

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expenses of Homology incurred in connection with the disposition of Legacy Assets and any contingent obligations or liabilities arising from such dispositions;

 

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any and all liabilities of Homology (A) to any current or former employee, officer, director, independent contractor or other non-employee service provider of Homology or any of its subsidiaries for change in control or transaction bonuses, retention bonuses, severance or similar compensatory payments or benefits that are due and payable solely as a result of the completion of the transactions contemplated by the Merger Agreement (including the employer portion of any payroll or similar taxes payable with respect thereto), (B) with respect to the unfunded or underfunded portion of any accrued employer contributions to a defined contribution or any post-retirement health and welfare benefit plan, (C) accrued but unpaid bonuses, severance and vacation or paid time off (including the employer portion of payroll or similar taxes payable with respect thereto), (D) with respect to accounts payable, accruals or other current liabilities (which will include Homology’s total deductible under its director’ and officers’ insurance, less amounts paid prior to the closing date of the Merger (other than in connection with any stockholder litigation against Homology or any of its directors relating to the Merger Agreement or the transactions contemplated by the Merger Agreement), and (E) with respect to contractual commitments for future payments under Homology’s real estate leases to the extent such commitments are incurred prior to the closing of the Merger;

plus:

 

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all prepaid expenses set forth in the Homology disclosure schedule;

 

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expenses paid, or liabilities incurred, prior to closing, that are approved in writing by Q32 to be covered by Homology’s director’ and officers’ liability insurance in excess of the deductible and within overall policy limits;

 

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prepaid deposits set forth in the Homology disclosure schedule;

minus:

 

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that number of shares of Homology Common Stock calculated by multiplying the maximum statutory withholding rate for such holder in connection with such issuance by the number of shares of Homology common stock to be issued in connection with the vesting and settlement of each outstanding and unvested Homology restricted stock unit, and the employer portion of any payroll or similar taxes payable as a result of the vesting and settlement of each outstanding and unvested Homology restricted stock unit.

For the avoidance of doubt, (1) the cash and cash equivalents received in the Pre-Closing Financing will be excluded from the calculation of Homology Net Cash and (2) the cash, cash equivalents and marketable securities received from the disposition of Legacy Assets will be included in the calculation of Homology Net Cash.

Not less than ten business days prior to the anticipated date of the closing of the Merger as mutually agreed in good faith by Homology and Q32, Homology will deliver to Q32 a net cash schedule setting forth, in reasonable detail, Homology’s good faith estimated calculation of the Homology Net Cash as of the close of business on the closing date of the Merger, prepared and certified by Homology’s Chief Financial Officer (or if there is no Chief Financial Officer, the principal financial and accounting officer of Homology) together with the

 

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relevant work papers and back-up materials used or useful in preparing the Net Cash schedule as reasonably requested by Q32.

Within five business days after delivery of such Net Cash schedule (the last day of such period referred to as the response date), Q32 will have the right to dispute any part of the Net Cash schedule by delivering a written notice to that effect to Homology (referred to herein as a dispute notice). Any dispute notice will identify in reasonable detail and, to the extent known, the nature and amounts of any proposed revisions to Homology’s Net Cash calculation.

If Q32 disputes the Net Cash schedule, the parties shall attempt in good faith to resolve the disputed items and negotiate an agreed-upon determination of Net Cash. If the parties are unable to negotiate an agreed-upon determination of Net Cash or any component thereof within two calendar days after the delivery of Q32’s dispute notice, any remaining disagreements will be referred to an independent auditor of recognized national standing jointly selected by Homology and Q32 or another independent auditor of recognized national standing mutually agreed upon by Homology and Q32. The determination of the amount of Net Cash made by such accounting firm shall be final and binding on Homology and Q32.

Homology’s Net Cash balance is subject to numerous factors, some of which are outside of Homology’s control. The actual amount of Net Cash will depend significantly on the timing of the closing of the Merger. In addition, the closing of the Merger could be delayed if Homology and Q32 are not able to agree upon the amount of Homology’s Net Cash as of the cash determination time.

Treatment of Q32 Options

At the Effective Time, each option to purchase shares of Q32 common stock outstanding as of immediately prior to the Effective Time will be automatically converted into an option to acquire, on the same terms and conditions (including the same vesting and exercisability terms and conditions), the number of shares of Homology common stock equal to the number of shares of Q32 common stock subject to such option as of immediately prior to the Effective Time multiplied by the exchange ratio formula in the Merger Agreement and rounding that result down to the nearest whole number of shares, at a per share exercise price determined by dividing the per share exercise price of such Q32 Option immediately prior to the Effective Time by the exchange ratio formula in the Merger Agreement, rounding up to the nearest whole cent.

Treatment of Q32 Warrants

At the Effective Time, each Q32 Warrant, to the extent outstanding and unexercised, will automatically, without any action on the part of the holder thereof, be converted into a warrant to acquire a number of shares of Homology common stock. Each Assumed Warrant will be subject to the same terms and conditions as were applicable to such corresponding Q32 Warrant immediately prior to the Effective Time (including applicable vesting conditions), except (i) each Assumed Warrant will be exercisable (or will become exercisable in accordance with its terms) for that number of whole shares of Homology common stock equal to the product of the number of shares of Q32 common stock that were issuable upon exercise of such Q32 Warrant immediately prior to the Effective Time multiplied by the exchange ratio formula in the Merger Agreement, rounded down to the nearest whole number of shares of Homology common stock, (ii) the per share exercise price for the shares of Homology common stock issuable upon exercise of such Assumed Warrant will be equal to the quotient determined by dividing the exercise price per share of Q32 common stock at which such Q32 Warrant was exercisable immediately prior to the Effective Time by the exchange ratio formula in the Merger Agreement, rounded up to the nearest whole cent, and (iii) for terms rendered inoperative by reason of the transactions contemplated by the Merger Agreement.

Treatment of Homology Common Stock, Homology Options and Homology Restricted Stock Units

Each outstanding Homology ITM Option will vest in full immediately prior to the Effective Time and remain outstanding, subject to proportionate adjustment in accordance with the terms of Homology’s 2018

 

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Incentive Award Plan or 2015 Stock Incentive Plan, as applicable, to reflect the Reverse Stock Split and the issuance of the CVRs, and each option to purchase Homology common stock that is not a Homology ITM Option will be cancelled for no consideration immediately prior to the Effective Time. Each Homology Restricted Stock Unit that is outstanding will vest in full immediately prior to the Effective Time, and the holder of each unsettled Homology Restricted Stock Unit will receive immediately prior to the Effective Time, the number of shares of Homology common stock equal to the number of vested and unsettled shares of Homology common stock underlying such Homology Restricted Stock Unit.

Homology Employee Stock Purchase Plan

In accordance with the Merger Agreement, Homology’s board of directors has adopted resolutions (i) providing that (a) no offering periods or purchase periods will begin after or in addition to the Current Offering Period, (b) no payroll deductions or other contributions will be made or effected after the Current Offering Period, and (c) each Homology ESPP participant’s accumulated contributions under the Homology ESPP will be returned to the participant in accordance with the terms of the Homology ESPP and (ii) terminating the Current Offering Period.

Procedures for Exchanging Q32 Stock Certificates

On or prior to the closing date of the Merger, Homology and Q32 will jointly select an exchange agent and, at the Effective Time, Homology will deposit with the exchange agent evidence of book-entry shares representing the shares of Homology common stock issuable pursuant to the terms of the Merger Agreement in exchange for shares of Q32 common stock.

Promptly after the Effective Time, the exchange agent will mail to each record holder of Q32 common stock that were converted into the right to receive Q32 Merger Shares (i) a letter of transmittal and (ii) instructions effecting the surrender of Q32 common stock in exchange for book-entry shares of Homology common stock. Upon delivery to the exchange agent of a duly executed letter of transmittal and such other documents as may reasonably be required by the exchange agent or Homology, the holder of such Q32 common stock shall be entitled to receive in exchange therefor book-entry shares representing that Q32 Merger Shares that such holder has the right to receive pursuant to the Merger Agreement. No dividends or other distributions declared or made with respect to Homology common stock with a record date after the Effective Time shall be paid to the holder of any Q32 common stock with respect to the shares of Homology common stock that such holder has the right to receive in the Merger until such holder delivers a duly executed letter of transmittal (at which time such holder shall be entitled, subject to the effect of applicable abandoned property, escheat or similar laws, to receive all such dividends and distributions, without interest).

Any shares of Homology common stock deposited with the exchange agent that remain undistributed to holders of Q32 common stock as of the date that is 180 days after the closing date of the Merger shall be delivered to Homology upon demand, and any holders of Q32 common stock who have not theretofore delivered a duly executed letter of transmittal in accordance with the terms and conditions of the Merger Agreement shall thereafter look only to Homology for satisfaction of their claims for Homology common stock and any dividends or distributions with respect to shares of Homology common stock.

HOLDERS OF Q32 COMMON STOCK SHOULD NOT SEND IN THEIR Q32 STOCK CERTIFICATES UNTIL THEY RECEIVE A LETTER OF TRANSMITTAL FROM THE EXCHANGE AGENT WITH INSTRUCTIONS FOR THE SURRENDER OF Q32 STOCK CERTIFICATES.

Directors and Officers of Homology Following the Merger

Pursuant to the Merger Agreement, each of the directors and officers of Homology who will not continue as directors or officers of Homology following the Effective Time will resign effective as of the Effective Time.

 

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Effective as of the Effective Time, the Homology board of directors will consist of a total of nine directors, seven of whom will be designated by Q32, and two of whom will be designated by Homology. Q32 may designate individuals to serve as members of the combined company’s board of directors at any time prior to three business days before the Effective Time. Homology has designated Arthur Tzianabos, Ph.D. and Mary Thistle to serve as members of the board of directors.

In addition, upon the closing of the Merger, Jodie Morrison will serve as President and Chief Executive Officer, Lee Kalowski will serve as interim Chief Financial Officer, Shelia Violette, Ph.D. will serve as Chief Scientific Officer, and Jason Campagna, M.D., Ph.D. will serve as Chief Medical Officer.

Amendment of the Restated Certificate of Incorporation of Homology

Homology agreed to amend its Restated Certificate of Incorporation to (i) change the name of Homology to “Q32 Bio Inc.,” (ii) effect the proposed Reverse Stock Split and authorize sufficient Homology common stock for the issuance of Homology common stock to the stockholders of Q32 pursuant to the terms of the Merger Agreement and (iii) make such other changes as are mutually agreeable to Homology and Q32.

Potential Asset Sale

Homology is entitled, but is under no obligation, to sell, transfer, license, assign or otherwise divest any or all of the assets and rights primarily relating to Homology’s HMI-103 (Adult/Pediatric PKU), HMI-203 (MPS II (Hunter Syndrome)), HMI-204 (MLD) and Homology’s Capsids and AAVHSC Platform, or the Legacy Assets, including any equity interests held directly or indirectly by Homology in Oxford Biomedica Solutions LLC or its affiliates, or the Oxford Assets, in a transaction or series of transactions, or the Legacy Asset Disposition.

Each party acknowledges that Homology may not be successful in completing, or may determine not to proceed with, the Legacy Asset Disposition. Notwithstanding the foregoing, Homology may not enter into any agreement with respect to the Legacy Asset Disposition that would result in a material continuing obligation or liability without the prior written consent of Q32 (not to be unreasonably withheld, conditioned or delayed), provided, however, that Homology will provide Q32 with a copy of any agreement with respect to a Legacy Asset Disposition that would be reasonably likely to result in a material continuing obligation or liability of either Homology or Q32 on or after the Effective Time at least five business days prior to entry into such agreement.

If a Legacy Asset is sold on or prior to the closing date, the cash proceeds from such disposition will be included in the calculation of Homology Net Cash pursuant to the Merger Agreement, which will have the effect of decreasing the number of shares issuable as consideration to the Q32 securityholders as of immediately prior to the Merger and proportionately increasing the relative ownership of the combined company by Homology securityholders as of immediately prior to the Merger. Any sale, transfer, license, assignment or other divestiture of Legacy Assets (other then HMI-203) after the Closing Date shall be governed by the terms and conditions of the CVR Agreement as described below in the sections titled “The Merger Agreement–Contingent Value Rights” and “Agreements Related to the Merger–Contingent Value Rights Agreement.”

Representations and Warranties

The Merger Agreement contains customary representations and warranties of Homology and Q32 for a transaction of this type relating to, among other things:

 

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due organization; subsidiaries,

 

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organizational documents,

 

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authority; binding nature of the Merger Agreement,

 

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vote required,

 

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non-contravention; consents,

 

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capitalization,

 

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financial statements,

 

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absence of changes,

 

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absence of undisclosed liabilities,

 

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title to assets,

 

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real property; leasehold,

 

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intellectual property,

 

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agreements, contracts and commitments,

 

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compliance; permits; restrictions,

 

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legal proceedings; orders,

 

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tax matters,

 

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employee and labor matters; benefit plans,

 

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environmental matters,

 

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insurance,

 

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no financial advisors,

 

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transactions with affiliates,

 

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privacy and data security, and

 

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Pre-Closing Financing.

Q32 makes additional representations and warranties, relating to the Pre-Closing Financing described in the section titled “Q32 Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

Homology makes additional representations and warranties relating to, among other things, SEC filings and the valid issuance of Homology common stock in connection with the Merger.

The representations and warranties are, in many respects, qualified by materiality and knowledge, and will not survive the Merger, but their accuracy forms the basis of one of the conditions to the obligations of Homology and Q32 to complete the Merger.

Covenants; Conduct of Business Pending the Merger

Q32 has agreed that until the earlier of the Effective Time and the termination of the Merger Agreement, except as required by applicable law, as otherwise provided by the Merger Agreement and the transactions contemplated thereby or with Homology’s prior written consent (not to be unreasonably withheld, conditioned or delayed), Q32 will, and will cause its subsidiaries to, use their commercially reasonable efforts to conduct its operations in the ordinary course of its business and to preserve intact the present business organizations and goodwill of the business and the present relationships of the business with material customers and suppliers. Without limiting the generality of the foregoing, until the earlier of the Effective Time and the termination of the Merger Agreement, except as required by applicable law, as otherwise provided by the Merger Agreement and the transactions contemplated thereby or with Homology’s prior written consent (not to be unreasonably withheld, conditioned or delayed), Q32 will not, and will cause its subsidiaries not to:

 

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sell, lease, license or otherwise dispose of any material assets of Q32, or in either case, any interests therein, except (i) pursuant to existing contracts, (ii) for sales or licensing of products to customers or (iii) otherwise in the ordinary course of its business;

 

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take any action with respect to any equity interests of Q32 or any of its subsidiaries, including any issuance, sale, transfer, redemption, repurchase, recapitalization, adjustment, split, combination, reclassification, dividend, distribution or any other action in respect thereof;

 

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create, incur, assume, guarantee or repay (other than any mandatory repayments) any indebtedness, other than in the ordinary course of business or as approved by the Q32 board of directors;

 

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issue, deliver, sell, grant, pledge, transfer, subject to any encumbrance or dispose of any Q32 capital stock or the securities of any subsidiary of Q32;

 

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create or otherwise incur any encumbrance on any material asset of Q32 or any of its subsidiaries, other than permitted encumbrances pursuant to the Merger Agreement;

 

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make any loans, advances or capital contributions to, or investments in, any person other than Q32;

 

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adversely amend or otherwise adversely modify in any material respect or terminate (excluding any expiration in accordance with its terms) any material contract, other than any amendment or modification entered into in the ordinary course of its business and containing terms not materially less favorable to Q32 than the terms of such contract in effect as of the date of the Merger Agreement;

 

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enter into any contract that would be required to be disclosed as a material contract if such contract were in effect as of the date of the Merger Agreement, other than any such contract entered into in the ordinary course of its business;

 

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except as required by any Q32 employee plan or as required by applicable law, (i) increase any salary, wage or other compensation or benefit to, or enter into or amend any employment, retention, change-in-control, termination or severance agreement with, any current or former employee, consultant, officer, director, independent contractor or other non-employee service provider of Q32 or any of its subsidiaries, other than annual increases in the base compensation in the ordinary course of business with respect to employees whose annual base compensation is less than $500,000 and provided that such increases do not, individually or in the aggregate, result in any material increase in costs, obligations or liabilities for Q32 and its subsidiaries, (ii) grant or pay any bonuses to any current or former employee, consultant, officer, director, independent contractor or other non-employee service provider of Q32 or any of its subsidiaries, other than in the ordinary course of business, or (iii) establish, enter into or adopt any new material Q32 employee plan or any plan, program, policy, agreement or arrangement that would be a material Q32 employee plan if it was in effect on the closing date of the Merger or amend or modify, in a manner that would, individually or in the aggregate, materially increase costs, obligations or liabilities for Q32 and its subsidiaries or the combined company, any existing Q32 employee plan or accelerate the vesting of any compensation (including stock options, restricted stock, restricted stock units, phantom units, warrants, other shares of capital stock or rights of any kind to acquire any shares of capital stock or equity-based awards) for the benefit of any current or former employee, consultant, officer, director, independent contractor or other non-employee service provider of Q32 or any of its subsidiaries, other than in the ordinary course of its business;

 

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adopt, enter into, amend or terminate any collective bargaining agreement or contract with any labor union, works council or labor organization;

 

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settle any material legal proceeding involving Q32 or any of its subsidiaries or relating to the transactions contemplated by the Merger Agreement;

 

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make or change any material tax election, change any annual tax accounting period, enter into any closing agreement with a governmental authority with respect to material taxes or settle any tax claim with respect to material taxes, in each case, except if such action would not reasonably be expected to have a material and adverse effect on Q32 following the completion of the Merger;

 

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take any action, or knowingly fail to take any action, where such action or failure to act would reasonably be expected to prevent the Merger from qualifying as a “plan of reorganization” for

 

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purposes of Sections 354, 361 and 368 of the Code and within the meaning of Section 368 of the Code and Treasury Regulations Section 1.368-2(g);

 

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make any material change in any method of financial accounting or financial accounting practice of Q32 or any of its subsidiaries, except for any such change required by reason of a change in GAAP or other applicable financial accounting standards;

 

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other than in connection with actions contemplated by the Merger Agreement, adopt, approve, consent to or propose any change in the organizational documents of Q32 or any of its subsidiaries; or

 

  •  

agree or commit to do any of the foregoing.

Homology has agreed that until the earlier of the Effective Time and the termination of the Merger Agreement, except as required by applicable law, as otherwise provided by the Merger Agreement and the transactions contemplated thereby or with Q32’s prior written consent (not to be unreasonably withheld, conditioned or delayed), Homology will, and will cause its subsidiaries to, use their commercially reasonable efforts to conduct its operations in the ordinary course of its business and to preserve intact the present business organizations and goodwill of the business and the present relationships of the business with material customers and suppliers. Without limiting the generality of the foregoing, until the earlier of the Effective Time and the termination of the Merger Agreement, except as required by applicable law, as otherwise provided by the Merger Agreement and the transactions contemplated thereby or with Q32’s prior written consent (not to be unreasonably withheld, conditioned or delayed), Homology will not, and will cause its subsidiaries not to:

 

  •  

sell, lease, license or otherwise dispose of any material assets of Homology, or in either case, any interests therein, except (i) pursuant to existing contracts, (ii) for sales or licensing of products to customers or (iii) otherwise in the ordinary course of its business;

 

  •  

except for the issuance of securities under the Merger Agreement, take any action with respect to any equity interests of Homology or any of its subsidiaries, including any issuance, sale, transfer, redemption, repurchase, recapitalization, adjustment, split, combination, reclassification, dividend, distribution or any other action in respect thereof;

 

  •  

create, incur, assume, guarantee or repay (other than any mandatory repayments) any indebtedness;

 

  •  

issue, deliver, sell, grant, pledge, transfer, subject to any encumbrance or dispose of any Homology common stock or the securities of any subsidiary of Homology;

 

  •  

create or otherwise incur any encumbrance on any material asset of Homology or any of its subsidiaries, other than permitted encumbrances;

 

  •  

make any loans, advance or capital contributions to, or investments in, any person other than Homology;

 

  •  

adversely amend or otherwise adversely modify in any material respect or terminate (excluding any expiration in accordance with its terms) any material contract, other than any amendment or modification entered into in the ordinary course of its business and containing terms, not materially less favorable to Homology than the terms of such contract in effect as of the date of the Merger Agreement;

 

  •  

enter into any contract that would be required to be disclosed as a material contract if such contract were in effect as of the date the Merger Agreement, other than any such contract entered into in the ordinary course of business;

 

  •  

except as required by any Homology employee plan, as required by applicable law or the Merger Agreement or with respect to the adoption and approval of the 2024 Plan and the 2024 ESPP (i) increase any salary, wage or other compensation or benefit to, or enter into or amend any employment, retention, change-in-control, termination or severance agreement with, any current or former employee, officer, director, independent contractor or other non-employee service provider of

 

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Homology or any of its subsidiaries, other than as set forth in the Homology disclosure schedule to the Merger Agreement and provided that such increases do not, individually or in the aggregate, result in any material increase in costs, obligations or liabilities for Homology and its subsidiaries, (ii) grant or pay any bonuses to any current or former employee, officer, director, independent contractor or other non-employee service provider of Homology or any of its subsidiaries, (iii) establish, enter into or adopt any new Homology employee plan or any plan, program, policy, agreement or arrangement that would be a material Homology employee plan if it was in effect on the closing date of the Merger or amend or modify, in a manner that would, individually or in the aggregate, materially increase costs, obligations or liabilities for Homology and its subsidiaries or the combined company, any existing Homology employee plan or accelerate the vesting of any compensation (including stock options, restricted stock, restricted stock units, phantom units, warrants, other shares of capital stock or rights of any kind to acquire any shares of capital stock or equity-based awards) for the benefit of any current or former employee, officer, director, independent contractor or other non-employee service provider of Homology or any of its subsidiaries, (iv) grant any current or former employee, consultant, officer, director, independent contractor or other non-employee service provider of Homology or any of its subsidiaries any right to receive, or pay to any current or former employee, consultant, officer, director, independent contractor or other non-employee service provider of Homology or any of its subsidiaries any severance, change in control, transaction, retention, termination or similar compensation or benefits or increases therein, (v) take any action to accelerate any payment or benefit, or the funding of any payment or benefit, payable or to be provided to any current or former employee, officer, director, independent contractor or other non-employee service provider of Homology or any of its subsidiaries, (vi) grant any new long-term incentive or equity-based awards, or amend or modify the terms of any such outstanding awards under any Homology employee plan or (vii) hire, terminate (other than for cause), promote or change the employment status or title of any current or former employee, officer, director, independent contractor or other non-employee service provider of Homology or any of its subsidiaries;

 

  •  

adopt, enter into, amend or terminate any collective bargaining agreement or contract with any labor union, works council or labor organization;

 

  •  

settle any material legal proceeding involving Homology or relating to the transactions contemplated by the Merger Agreement;

 

  •  

make or change any material tax election, change any annual tax accounting period, enter into any closing agreement with a governmental authority with respect to material taxes or settle any tax claim with respect to material taxes, in each case, except if such action would not reasonably be expected to have a material and adverse effect on Homology following the completion of the Merger;

 

  •  

take any action, or knowingly fail to take any action, where such action or failure to act would reasonably be expected to prevent the Merger from qualifying as a “plan of reorganization” for purposes of Sections 354, 361 and 368 of the Code and within the meaning of Section 368 of the Code and Treasury Regulations Section 1.368-2(g);

 

  •  

make any material change in any method of financial accounting or financial accounting practice of Homology, except for any such change required by reason of a change in GAAP or other applicable financial accounting standards;

 

  •  

other than in connection with actions contemplated by the Merger Agreement, adopt, approve, consent to or propose any change in the organizational documents of Homology; or

 

  •  

agree or commit to do any of the foregoing.

Contingent Value Rights

Prior to the Effective Time, Homology will declare a distribution to its common stockholders of record of the right to receive one CVR for each outstanding share of Homology common stock held by such stockholder as

 

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of the record date, each representing the right to receive contingent payments upon the occurrence of certain events set forth in, and subject to and in accordance with the terms and conditions of, the CVR Agreement, discussed in greater detail under the section titled “Agreements Related to the Merger–Contingent Value Rights Agreement.” The record date for such distribution will be the close of business on the last business day prior to the day on which the Effective Time occurs and the payment date for which shall be three business days after the Effective Time; provided that the payment of such distribution may be conditioned upon the occurrence of the Effective Time. In connection with such distribution, Homology will cause the CVR Agreement to be duly authorized, executed and delivered by Homology and Equiniti Trust Company, LLC (or such other nationally recognized rights agent agreed to between Homology and Q32).

Non-Solicitation

Each of Homology and Q32 have agreed that, except as described below, Homology and Q32 and any of their respective subsidiaries will not, nor will either party or any of its subsidiaries authorize any of the directors, officers, employees, agents, attorneys, accountants, investment bankers, advisors or representatives retained by it or any of its subsidiaries to, directly or indirectly:

 

  •  

solicit, initiate or knowingly encourage, induce or facilitate the communication, making, submission or announcement of any Acquisition Proposal or Acquisition Inquiry or take any action not in the ordinary course of business that could reasonably be expected to lead to an Acquisition Proposal or Acquisition Inquiry;

 

  •  

furnish any non-public information regarding such party to any person (other than Q32 or Homology) in connection with or in response to an Acquisition Proposal or Acquisition Inquiry;

 

  •  

engage in discussions or negotiations with any person with respect to such Acquisition Proposal or Acquisition Inquiry;

 

  •  

approve, endorse or recommend any Acquisition Proposal;

 

  •  

execute or enter into any letter of intent or any contract contemplating or otherwise relating to any Acquisition Transaction; or

 

  •  

publicly propose to do any of the foregoing.

An “Acquisition Inquiry” means, with respect to a party, an inquiry, indication of interest or request for information (other than an inquiry, indication of interest or request for information made or submitted by Q32, on the one hand, or Homology, on the other hand, to the other party) that would reasonably be expected to lead to an Acquisition Proposal, other than, as applicable, with respect to the potential asset sale described in the section titled, “The Merger Agreement—Potential Asset Sale” or the Pre-Closing Financing described in the section titled, “Q32 Management’s Discussion and Analysis of Financial Condition and Results of Operations-Recent Developments-Proposed Merger & Pre-Closing Financing.”

An “Acquisition Proposal” means, with respect to a party, any offer or proposal, whether written or oral (other than an offer or proposal made or submitted by or on behalf of Q32 or any of its affiliates, on the one hand, or by or on behalf of Homology or any of its affiliates, on the other hand, to the other party) contemplating or otherwise relating to any Acquisition Transaction with such party, other than, as applicable, with respect to the potential asset sale described in the section titled, “The Merger Agreement—Potential Asset Sale” or the Pre-Closing Financing described in the section titled, “Q32 Management’s Discussion and Analysis of Financial Condition and Results of Operations—Recent Developments—Proposed Merger & Pre-Closing Financing.”

An “Acquisition Transaction” means any transaction or series of related transactions (other than, as applicable, with respect to the potential asset sale described in the section titled, “The Merger Agreement—Potential Asset Sale” or the Pre-Closing Financing Described in the section titled, “Q32 Management’s

 

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Discussion and Analysis of Financial Condition and Results of Operations—Recent Developments—Proposed Merger & Pre-Closing Financing”) involving:

 

  •  

any merger, consolidation, amalgamation, share exchange, business combination, issuance of securities, acquisition of securities, reorganization, recapitalization, tender offer, exchange offer or other similar transaction: (A) in which a party is a constituent entity, (B) in which a person or “group” (as defined in the Exchange Act and the rules promulgated thereunder) of persons directly or indirectly acquires beneficial or record ownership of securities representing more than 20% of the outstanding securities of any class of voting securities of a party or any of its subsidiaries or (C) in which a party or any of its subsidiaries issues securities representing more than 20% of the outstanding securities of any class of voting securities of such party or any of its subsidiaries; or

 

  •  

any sale, lease, exchange, transfer, license, acquisition or disposition of any business or businesses or assets that constitute or account for 20% or more of the consolidated book value or the fair market value of the assets of a party and its subsidiaries, taken as a whole.

Notwithstanding the foregoing, before obtaining the applicable approvals of the Homology stockholders required to consummate the Merger, Homology may furnish non-public information regarding Homology or its subsidiaries to, and may enter into discussions or negotiations with, any person in response to a bona fide written Acquisition Proposal by Homology, which Homology’s board of determines in good faith, after consultation with Homology’s financial advisors and outside legal counsel, constitutes or is reasonably likely to result in, a Superior Offer (and is not withdrawn) if:

 

  •  

neither Homology nor any representative of Homology shall have breached the non-solicitation provisions of the Merger Agreement in any material respect;

 

  •  

the Homology board of directors concludes in good faith based on the advice of outside legal counsel, that failure to take such action would reasonably be expected to be inconsistent with the fiduciary duties of the Homology board of directors under applicable law;

 

  •  

as promptly as possible after (and in any event within forty-eight hours of) initially furnishing any such non-public information to, or entering into discussions with, such person, Homology gives Q32 written notice of the identity of such person (unless such disclosure is prohibited pursuant to the terms of any confidentiality agreement with such person or group that is in effect on the date of the Merger Agreement) to Q32, and of Homology’s intention to furnish non-public information to, or enter into discussions with, such person;

 

  •  

Homology receives from such person an executed confidentiality agreement in accordance with the terms and conditions of the Merger Agreement; and

 

  •  

as promptly as possible after (and in any event within forty-eight hours of) furnishing any such non-public information to such person, Homology furnishes such non-public information to Q32 (to the extent such information has not been previously furnished by Homology to Q32).

Notwithstanding the foregoing, Homology and its representatives may, in any event (without the Homology board of directors having to make a determination as described in the second bullet point above, contact any person to (i) seek to clarify and understand the terms and conditions of any Acquisition Proposal made by such person solely to determine whether such Acquisition Proposal constitutes, or is reasonably likely to result in, a Superior Offer and (ii) inform such person that has made, or to the knowledge of Homology is considering making an Acquisition Proposal.

A “Superior Offer” means an unsolicited bona fide written Acquisition Proposal (with all references to 20% in the definition of Acquisition Transaction being treated as references to 50% for these purposes) that: (i) was not obtained or made as a direct or indirect result of a breach of (or violation of) the Merger Agreement and (ii) is on terms and conditions that the Q32 board of directors or the Homology board of directors, as applicable,

 

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determines in good faith, based on such matters that it deems relevant (including the likelihood of consummation thereof, the financing terms and any termination or break-up fees and conditions to consummation thereof), as well as any written offer by the other party to the Merger Agreement to amend the terms of the Merger Agreement, and following consultation with its outside legal counsel and financial advisors, if any, are more favorable, from a financial point of view, to Q32’s stockholders or Homology’s stockholders, as applicable, than the terms of the Merger Agreement and the transactions contemplated thereby and is not subject to any financing conditions (and if financing is required, such financing is then fully committed to the third party).

The Merger Agreement also provides that if any party or any representative of such party receives an Acquisition Proposal or Acquisition Inquiry, then such party shall promptly (and in no event later than one business day after such party becomes aware of such Acquisition Proposal or Acquisition Inquiry) advise the other party orally and in writing of such Acquisition Proposal or Acquisition Inquiry (including the identity of the person making or submitting such Acquisition Proposal or Acquisition Inquiry, and provide a copy of the Acquisition Proposal or Acquisition Inquiry, of if the Acquisition Proposal or Acquisition Inquiry is not written, the terms thereof). The Merger Agreement provides that such party shall keep the other party reasonably informed with respect to the status and terms of any such Acquisition Proposal or Acquisition Inquiry and any material modification or material proposed modification thereto. Additionally, each party shall provide the other party with at least four business days’ written notice of a meeting of its board of directors (or any committee thereof) at which its board of directors (or any committee thereof) is reasonably expected to consider an Acquisition Proposal or Acquisition Inquiry it has received.

Board Recommendation Change

Under the Merger Agreement, subject to certain exceptions described below, Homology agreed that its board of directors may not take any of the following actions, each of which are referred to in this proxy statement/prospectus as a “Homology Board Adverse Recommendation Change”:

 

  •  

withhold, amend, withdraw or modify (or publicly propose to withhold, amend, withdraw or modify) the recommendation of the Homology board of directors in a manner adverse to Q32;

 

  •  

resolve, or have any committee of the Homology board of directors resolve, to withdraw or modify the recommendation of the Homology board of directors in a manner adverse to Q32; or

 

  •  

adopt, approve or recommend (or publicly propose to adopt, approve or recommend) any Acquisition Proposal.

However, notwithstanding the foregoing, at any time prior to the approval of the proposals to be considered at the Homology stockholder meeting by the necessary vote of Homology stockholders, if Homology has received a bona fide written Superior Offer, the Homology board of directors may make a Homology Board Adverse Recommendation Change if, but only if, following the receipt of and on account of such Superior Offer:

 

  •  

the Homology board of directors determines in good faith, after consultation with its outside legal counsel, that the failure to make a Homology Board Adverse Recommendation Change would reasonably be expected to be inconsistent with its fiduciary duties under applicable law;

 

  •  

Homology has, and has caused its financial advisors and outside legal counsel to, during a three business day period commencing on the date that the Homology board of directors notifies Q32 in writing of its intent to make a Homology Board Adverse Recommendation Change, negotiated with Q32 in good faith to make such adjustments to the terms and conditions of the Merger Agreement so that such Acquisition Proposal ceases to constitute a Superior Offer; and

 

  •  

if after Q32 shall have delivered to Homology a written offer to alter the terms or conditions of the Merger Agreement during the three business day period commencing on the date that the Homology board of directors notifies Q32 in writing of its intent to make a Homology Board Adverse Recommendation Change (or if Q32 declines to do so), the Homology board of directors shall have

 

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determined in good faith, after consultation with its outside legal counsel, that the failure to withhold, amend, withdraw or modify the recommendation of the Homology board of directors would reasonably be expected to be inconsistent with its fiduciary duties under applicable law (after taking into account such alterations of the terms and conditions of the Merger Agreement, if any); provided that (x) Q32 receives written notice from Homology confirming that the Homology board of directors has determined to change its recommendation during such three business day period, which notice shall include a description in reasonable detail of the reasons for such Homology Board Adverse Recommendation Change, and written copies of any relevant proposed transaction agreements with any party making a potential Superior Offer, (y) during any such five business day period, Q32 shall be entitled to deliver to Homology one or more counterproposals to such Acquisition Proposal and Homology will, and cause its representatives to, negotiate with Q32 in good faith (to the extent Q32 desires to negotiate) to make such adjustments in the terms and conditions of the Merger Agreement so that the applicable Acquisition Proposal ceases to constitute a Superior Offer and (z) in the event of any material amendment to any Superior Offer (including any revision in price or percentage of the combined company that Homology’s stockholders would receive as a result of such potential Superior Offer), Homology shall be required to provide Q32 with notice of such material amendment and such three business day period shall be extended, if applicable, to ensure that at least two business days remain in the requisite notice period following such notification during which the parties shall comply again with the requirements of the Merger Agreement and the Homology board of directors shall not make a Homology Board Adverse Recommendation Change prior to the end of such notice period as so extended.

Under the Merger Agreement, subject to certain exceptions described below, Q32 has agreed that its board of directors may not take any of the following actions:

 

  •  

withdraw or modify (or publicly propose to withdraw or modify) the recommendation of the Q32 board of directors in a manner adverse to Homology;

 

  •  

resolve, or have any committee of the Q32 board of directors resolve, to withdraw or modify the recommendation of the Q32 board of directors in a manner adverse to Homology; or

 

  •  

adopt, approve or recommend (or publicly propose to adopt, approve or recommend) any Acquisition Proposal.

Meeting of Homology’s Stockholders and Written Consent of Q32’s Stockholders

Homology is obligated under the Merger Agreement to take all action necessary under applicable law to call, give notice of and hold a meeting of the holders of Homology common stock to consider and vote to approve the Merger Agreement and the transactions contemplated thereby, including the issuance of the shares of Homology common stock to the stockholders of Q32 pursuant to the terms of the Merger Agreement and the amendments to the Restated Certificate of Incorporation of Homology described in the section titled “The Merger Agreement-Amendment of the Restated Certificate of Incorporation of Homology”, or the Required Homology Stockholder Vote. The Homology stockholder meeting shall be held as promptly as practicable after the Registration Statement is declared effective under the Securities Act, and in any event no later than 45 days after the effective date of the Registration Statement. Homology shall take reasonable measures to ensure that all proxies solicited in connection with the Homology stockholder meeting are solicited in compliance with all applicable law.

Notwithstanding anything to the contrary contained in the Merger Agreement, if on the date of the Homology stockholder meeting, or a date preceding the date on which the Homology stockholder meeting is scheduled, Homology reasonably believes that (i) it will not receive proxies sufficient to obtain the requisite Homology stockholder vote, whether or not a quorum would be present or (ii) it will not have sufficient shares of Homology common stock represented (whether in person or by proxy) to constitute a quorum necessary to

 

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conduct the business of the Homology stockholder meeting, Homology may postpone or adjourn, or make one or more successive postponements or adjournments of, the Homology stockholder meeting as long as the date of the Homology stockholder meeting is not postponed or adjourned more than an aggregate of 30 calendar days in connection with any postponements or adjournments.

Promptly after the Registration Statement has been declared effective under the Securities Act, and in any event no later than two business days thereafter, Q32 shall prepare, with the cooperation of Homology, and cause to be mailed to the stockholders of Q32 an information statement, which shall include a copy of the Proxy Statement, and the Q32 stockholder written consent, in order to solicit the approval of Q32’s stockholders, including but not limited to Q32’s stockholders sufficient for the requisite Q32 stockholder vote in lieu of a meeting pursuant to Section 228 of Delaware law, for purposes of (i) adopting and approving the Merger Agreement and the transaction contemplated thereby, (ii) acknowledging that the approval given thereby is irrevocable, or (i) and (ii) together, the Required Q32 Stockholder Vote. Q32 shall use its reasonable best efforts to cause Q32 stockholders sufficient for the requisite Q32 stockholder vote to execute and deliver to Q32 the Q32 stockholder written consent promptly following delivery thereof, and in any event no later than fifteen days after the Registration Statement has been declared effective.

Regulatory Approvals

Each of the parties will use commercially reasonable efforts to file or otherwise submit, as soon as practicable after the date of the Merger Agreement, all applications, notices, reports and other documents reasonably required to be filed by such party with or otherwise submitted by such party to any governmental authority with respect to the transactions contemplated by the Merger Agreement, and to submit promptly any additional information requested by any such governmental authority. Homology and Q32 will respond as promptly as is practicable to respond in compliance with: (i) any inquiries or requests received from the Federal Trade Commission or the Department of Justice for additional information or documentation and (ii) any inquiries or requests received from any state attorney general, foreign antitrust or competition authority or other governmental authority in connection with antitrust or competition matters.

Indemnification and Insurance for Directors and Officers

Under the Merger Agreement, from the Effective Time through the sixth anniversary of the date on which the Effective Time occurs (or such period in which a director or officer of Homology or Q32, respectively, is asserting a claim for indemnification or other protections pursuant to the Merger Agreement to the extent arising prior to the end of such six-year period), each of Homology and the combined company agreed to indemnify and hold harmless each person who is now, or has been at any time prior to the date of the Merger Agreement, or who becomes prior to the Effective Time, a director or officer of Homology or Q32, respectively, against all claims, losses, liabilities, settlements, damages, judgments, fines and penalties and reasonable fees, costs and expenses, including attorneys’ fees and disbursements, incurred in connection with any claim, action, suit, proceeding or investigation, whether civil, criminal, administrative or investigative, formal or informal, arising out of or pertaining to the fact that the indemnified officer or director is or was a director or officer of Homology or of Q32, whether asserted or claimed prior to, at or after the Effective Time (including in connection with the Merger Agreement or the transactions contemplated thereby).

The Merger Agreement also provides that the provisions of the certificate of incorporation and bylaws of Homology with respect to indemnification, advancement of expenses and exculpation of present and former directors and officers of Homology that are presently set forth in the certificate of incorporation and bylaws of Homology will not be amended modified or repealed for a period of six years from the Effective Time in a manner that would adversely affect the rights thereunder of individuals who, at or prior to the Effective Time, were officers or directors of Homology, unless such modification is required by applicable law. The certificate of incorporation and bylaws of the combined company will contain, and Homology will cause the certificate of incorporation and bylaws of the combined company to so contain, provisions no less favorable with respect to

 

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indemnification, advancement of fees, costs and expenses and exculpation of future, present and former directors and officers as those presently set forth in the certificates of incorporation and bylaws of each of Homology and Q32.

From and after the Effective Time, Homology will maintain director’ and officers’ liability insurance policies, with an effective date as of the closing date of the Merger, on commercially available terms and conditions and with coverage limits customary for U.S. public companies similarly situated to Homology. In addition, Homology will secure and purchase a six year “tail policy” on Homology’s existing directors’ and officers’ liability insurance policy with an effective date as of the date of the closing of the Merger.

Section 16 Matters

Prior to the Effective Time, Homology will take all such steps as may be required to cause any acquisitions of Homology common stock and any options to purchase Homology common stock in connection with the Contemplated Transactions, by each individual who is reasonably expected to become subject to the reporting requirements of Section 16(a) of the Exchange Act with respect to Homology, to be exempt under Rule 16b-3 promulgated under the Exchange Act.

2024 Plan and 2024 ESPP

Prior to the Effective Time, the Homology board of directors will adopt the 2024 Plan and 2024 ESPP, each in form and substance as agreed to by Homology and Q32, reserving for issuance a number of shares of Homology common stock to be mutually agreed upon by Q32 and Homology (described in the sections titled “Interests of Q32 Directors and Executive Officers in the Merger—2024 Stock Incentive Plan” and “Interests of Q32 Bio Directors and Executive Officers in the Merger—2024 Employee Stock Purchase Plan”). Approval of the 2024 Plan and the 2024 ESPP by Homology’s stockholders is not a condition to closing.

Homology 401(k) Plan

Unless Q32 requests otherwise, Homology will, effective as of at least one day prior to the closing date of the Merger but subject to the closing of the Merger, terminate any Homology employee plan that is intended to meet the requirements of Section 401(k) of the Code and no further contributions will be made to such plan and all participant account balances will become 100% vested.

Additional Agreements

Each of Homology and Q32 has agreed to use commercially reasonable efforts to consummate the Merger and the other transactions contemplated by the Merger Agreement. In connection therewith, each party has agreed to:

 

  •  

make all filings and other submissions (if any) and give all notices (if any) required to be made and given by such party in connection with the transactions contemplated by the Merger Agreement;

 

  •  

use commercially reasonable efforts to obtain each consent (if any) reasonably required to be obtained (pursuant to any applicable law or contract, or otherwise) in connection with the transactions contemplated by the Merger Agreement or for such contract to remain in full force and effect;

 

  •  

use commercially reasonable efforts to lift any injunction prohibiting, or any other legal bar to, the transactions contemplated by the Merger Agreement; and

 

  •  

use commercially reasonable efforts to satisfy the conditions precedent to the consummation of the Merger Agreement.

 

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Pursuant to the Merger Agreement, Homology and Q32 have further agreed, among other things, that:

 

  •  

Homology will use commercially reasonable efforts to (a) maintain a listing on Nasdaq until the Effective Time and, to the extent required by the rules and regulations of Nasdaq, obtain approval of the listing of the combined company on Nasdaq, (b) to the extent required by the rules and regulations of Nasdaq, prepare and submit to Nasdaq a notification form for the listing of the shares of Homology common stock to be issued in connection with the transactions contemplated by the Merger Agreement and to cause such shares to be approved for listing; (c) prepare and timely submit to Nasdaq a notification form of the Reverse Stock Split and to submit a copy of the amendment to Homology’s certificate of incorporation to effect the Reverse Stock Split and other amendments contemplated by the Merger Agreement certified by the Secretary of State of the State of Delaware, to Nasdaq on or before the closing of the Merger; and (d) to the extent required by Nasdaq Marketplace Rule 5110, assist Q32 in preparing and filing an initial listing application for the Homology common stock on Nasdaq.

 

  •  

Each party will keep the other party reasonably informed regarding any stockholder litigation against Homology or any of its directors relating to Merger Agreement or the transactions contemplated by the Merger Agreement. Prior to the closing of the Merger, Homology will have the right to control the defense and settlement of any such stockholder litigation, but will reasonably consult with Q32 and consider any advice from Q32 and its representatives. Homology will promptly advise Q32 of the initiation of, and will keep Q32 reasonably apprised of any material developments in connection with, any such stockholder litigation.

 

  •  

Each party intends that the Merger will qualify as a “reorganization” within the meaning of Section 368(a) of the Code. Each party will for all tax purposes report consistently with the foregoing, and no party will take any position on any tax return that is inconsistent with the foregoing, unless otherwise required by a governmental authority as a result of a “determination” within the meaning of Section 1313(a) of the Code. In addition, each party will use commercially reasonable efforts to promptly notify each other if such party becomes aware of any non-public fact or circumstance that would reasonably be likely to prevent or impede the Merger from qualifying for the foregoing tax treatment.

Conditions to the Completion of the Merger

Each party’s obligation to effect the Merger and otherwise consummate the transactions contemplated under the Merger Agreement are subject to the satisfaction or, to the extent permitted by applicable law, the written waiver by each of the parties, at or prior to the completion of the Merger, of each of the following conditions:

 

  •  

No temporary restraining order, preliminary or permanent injunction or other order preventing the consummation of the transactions contemplated by the Merger Agreement shall have been issued by any court of competent jurisdiction or other governmental authority of competent jurisdiction and remain in effect and there shall not be any law which has the effect of making the consummation of the transactions contemplated by the Merger Agreement illegal.

 

  •  

The Required Homology Stockholder Vote and the Required Q32 Stockholder Vote shall have been obtained.

 

  •  

The approval of the listing of additional shares of Homology common stock on Nasdaq shall have been obtained and the shares of Homology common stock to be issued in the Merger pursuant to the Merger Agreement shall have been approved for listing (subject to official notice of issuance) on Nasdaq.

 

  •  

The lock-up agreements will continue to be in full force and effect as of immediately following the Effective Time.

 

  •  

The Registration Statement shall have become effective in accordance with the provisions of the Securities Act, and shall not be subject to any stop order or proceeding seeking a stop order with respect to the Registration Statement that has not been withdrawn.

 

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  •  

Q32 shall have effected the conversion of Q32 preferred stock to Q32 common stock immediately prior to the Effective Time in accordance with, and pursuant to the terms and conditions of, the organizational documents of Q32.

 

  •  

The representations and warranties of each of Homology and Q32 with respect to due organization, subsidiaries, organizational documents, authority, the binding nature of the Merger Agreement, required vote and no financial advisors shall have been true and correct in all material respects as of the date of the Merger Agreement and shall be true and correct on and as of the date of the completion of the Merger with the same force and effect as if made on and as of such date (except to the extent such representations and warranties are specifically made as of a particular date, in which case such representations and warranties shall be true and correct as of such date).

 

  •  

The representations and warranties of each of Homology and Q32 with respect to capitalization shall have been true and correct in all respects as of the date of the Merger Agreement and shall be true and correct on and as of the date of the completion of the Merger with the same force and effect as if made on and as of such date, except, in each case, (x) for such inaccuracies which are de minimis, individually or in the aggregate or (y) for those representations and warranties which address matters only as of a particular date (which representations and warranties shall have been true and correct, subject to the qualifications as set forth in the preceding clause (x), as of such particular date).

 

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The remaining representations and warranties of each of Homology and Q32 shall have been true and correct as of the date of the Merger Agreement and shall be true and correct in all respects on and as of the date of the completion of the Merger with the same force and effect as if made on such date except (i) in each case, or in the aggregate, where the failure to be so true and correct would not reasonably be expected to have a material adverse effect (without giving effect to any references therein to any Homology material adverse effect or Q32 material adverse effect, as applicable, or other materiality qualifications), (ii) where the failure to be true and correct as of the date of the completion of the Merger is the result of a Legacy Asset Disposition or abandonment of or failure to file, prosecute or maintain certain intellectual property rights of Homology (except for liability with respect to such intellectual property rights that remains with the surviving corporation), or (iii) for those representations and warranties which address matters only as of a particular date (which representations shall have been true and correct, subject to the qualifications as set forth in the preceding clause (i) and (ii), as of such particular date).

 

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Each party shall have performed and complied in all material respects with all covenants and agreements required to be performed or complied with by it under the Merger Agreement at or prior to the date of the completion of the Merger.

 

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A material adverse effect with respect to either party shall not have occurred since the date of the Merger Agreement and be continuing.

 

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Each party shall have delivered to the other party customary closing certificates signed by an executive officer of such party.

 

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The subscription agreement relating to the Pre-Closing Financing will continue to be full force and effect and cash proceeds of not less than $42.0 million have been received by Q32, or will be received by Q32 substantially simultaneously with the completion of the Merger, in connection with the consummation of the transactions contemplated by the subscription agreement.

Termination and Termination Fees

Termination of the Merger Agreement

The Merger Agreement may be terminated at any time before the Effective Time, whether before or after the required stockholder approvals to complete the Merger have been obtained, as set forth below:

(a)    by mutual written consent of Homology and Q32;

 

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(b)    by either Homology or Q32, if the Merger has not been consummated by May 16, 2024 (subject to possible extension as provided in the Merger Agreement); provided, however, that this right to terminate the Merger Agreement will not be available to any party whose action or failure to act has been a principal cause of the failure of the Merger to occur on or before May 16, 2024 and such action or failure to act constitutes a breach of the Merger Agreement; and provided, further, that such date will be extended by 90 days upon request of either party in the event that the SEC has not declared effective the registration statement on Form S-4, of which this proxy statement/prospectus is a part, by the date which is 25 business prior to May 16, 2024;

(c)    by either Homology or Q32 if a court of competent jurisdiction or governmental authority has issued a final and non-appealable order or taken any other action that permanently restrains, enjoins or otherwise prohibits the Merger or any of the other transactions contemplated by the Merger Agreement;

(d)    by Homology, if the required Q32 Stockholder Vote has not been obtained within fifteen days of the registration statement on Form S-4, of which this proxy statement/prospectus is a part, becoming effective; provided that this right to terminate the Merger Agreement will not be available to Homology once Q32 obtains such stockholder consent;

(e)    by either Homology or Q32, if the Homology stockholder meeting has been held and completed and Homology stockholders have taken a final vote on the proposals set forth herein to be considered at the Homology stockholder meeting, and the Required Homology Stockholder Vote has not been obtained;

(f)    by Q32, at any time prior to the approval by Homology stockholders by the Required Homology Stockholder Vote, if any of the following circumstances shall occur:

(i)    Homology fails to include in this proxy statement/prospectus the Homology board of directors’ recommendation that Homology stockholders approve the Merger proposal set forth herein to be considered at the Homology stockholder meeting;

(ii)    the Homology board of directors, or any committee thereof, makes a recommendation change adverse to Q32 or approves, endorses or recommends any Acquisition Proposal (other than with Q32); or

(iii)    Homology enters into any letter of intent or similar document or any contract relating to any Acquisition Proposal, other than a confidentiality agreement permitted pursuant to the Merger Agreement;

(g)    by Homology, at any time prior to the adoption of the Merger Agreement and the approval of the transactions contemplated therein by the Required Q32 Stockholder Vote, if any of the following circumstances shall occur:

(i)    the Q32 board of directors approves, endorses or recommends any Acquisition Proposal (other than with Homology); or

(ii)    Q32 enters into any letter of intent or similar document or any contract relating to any Acquisition Proposal, other than a confidentiality agreement permitted pursuant to the Merger Agreement.

(iii)    Homology enters into any letter of intent or similar document or any contract relating to any Acquisition Proposal, other than a confidentiality agreement permitted pursuant to the Merger Agreement;

(h)    by Q32, if Homology or Merger Sub has breached any of its representations, warranties, covenants or agreements contained in the Merger Agreement or if any representation or warranty of Homology or Merger Sub has become inaccurate, in either case, such that the conditions to the closing would not be satisfied as of time of such breach or inaccuracy; provided that Q32 is not then in material breach of any representation, warranty, covenant or agreement under the Merger Agreement; provided, further, that if such breach or inaccuracy is curable by Homology or Merger Sub, then the Merger Agreement will not terminate pursuant to this paragraph as a result of a particular breach or inaccuracy until the expiration of a 30-day period commencing upon delivery of written notice, from Q32 to Homology or Merger Sub, of such breach or inaccuracy and Q32’s intention to

 

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terminate pursuant to this paragraph (it being understood that the Merger Agreement will not terminate pursuant to this paragraph as a result of such particular breach or inaccuracy if such breach by Homology or Merger Sub is cured prior to such termination becoming effective); or

(i)    by Homology, if Q32 has breached any of its representations, warranties, covenants or agreements contained in the Merger Agreement or if any representation or warranty of Q32 has become inaccurate, in either case, such that the conditions to the closing would not be satisfied as of time of such breach or inaccuracy; provided that Homology is not then in material breach of any representation, warranty, covenant or agreement under the Merger Agreement; provided, further, if such breach or inaccuracy is curable by Q32, then the Merger Agreement will not terminate pursuant to this paragraph as a result of a particular breach or inaccuracy until the earlier of the expiration of a 30-day period after delivery of written notice, from Homology to Q32, of such breach or inaccuracy and Homology’s intention to terminate pursuant to this paragraph (it being understood that the Merger Agreement will not terminate pursuant to this paragraph as a result of such particular breach or inaccuracy if such breach by Q32 is cured prior to such termination becoming effective).

The party desiring to terminate the Merger Agreement will give the other party written notice of such termination, specifying the provisions thereof pursuant to which such termination is made and the basis for termination described in reasonable detail.

Termination Fees Payable by Homology

Homology must pay Q32 a termination fee of $2.4 million if (i) the Merger Agreement is terminated by (A) Homology or Q32 pursuant to clause (e) above, (B) at any time after the date of the Merger Agreement and prior to the Homology stockholder meeting an Acquisition Proposal with respect to Homology will have been publicly announced, disclosed or otherwise communicated to the Homology board of directors (and will not have been withdrawn), and (C) within 12 months after the date of such termination, Homology enters into a definitive agreement with respect to a subsequent transaction or consummates a subsequent transaction, or (ii) the Merger Agreement is terminated by Q32 pursuant to clause (f) above.

Termination Fees Payable by Q32

Q32 must pay Homology a termination fee of $5.85 million if the Merger Agreement is terminated pursuant to clause (d) or (g) above.

Amendment and Waiver

The Merger Agreement may not be amended except by an instrument in writing signed on behalf of each of Q32, Merger Sub and Homology. Such amendment requires the approval of the respective boards of directors of Q32, Merger Sub and Homology at any time, except that after the Merger Agreement has been adopted and approved by the Q32 stockholders or Homology stockholders, no amendment which by law requires further approval of the Q32 stockholders or Homology stockholders, as the case may be, may be made without such further approval.

Any provision of the Merger Agreement may be waived by any party solely on that party’s behalf, without the consent of any other party. The waiver must be expressly set forth in a written instrument duly executed and delivered on behalf of such party, which will only be valid in the specific instance in which it is given. No failure or delay on the part of any party with respect to the exercise of any power, right, privilege or remedy under the Merger Agreement will operate as a waiver of that said power, right, privilege or remedy. Furthermore, no single or partial exercise of any such power, right, privilege or remedy will preclude any other or further exercise thereof or of any other power, right, privilege or remedy.

Homology and Q32 have determined that, in light of the Reverse Stock Split, Homology will not need to authorize additional shares of Homology common stock. Accordingly, the parties have agreed that the

 

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authorization of additional shares of Homology common stock will not be required under the terms and conditions of the Merger Agreement and will not be a condition to closing under the Merger Agreement.

Fees and Expenses

The Merger Agreement provides all fees and expenses incurred in connection with the Merger Agreement and the transactions contemplated thereby shall be paid by the party incurring such expenses, whether or not the Merger is consummated, except as described above in the section titled “The Merger Agreement-Termination and Termination Fees,” and except that Homology and Q32 will pay the costs and expenses incurred in relation to the filings by the parties under any antitrust law applicable to the Merger Agreement and the transactions contemplated by the Merger Agreement, and Homology and Q32 will share equally in all fees and expenses incurred in relation to the printing and filing with the SEC of the registration statement on Form S-4 (including any financial statements and exhibits) and any related amendments or supplements.

 

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AGREEMENTS RELATED TO THE MERGER

Support Agreements

In order to induce Homology to enter into the Merger Agreement, certain Q32 stockholders are party to support agreements with Homology pursuant to which, among other things, each such stockholder has agreed, solely in his, her or its capacity as a Q32 stockholder, to vote all of his, her or its shares of Q32 capital stock in favor of (i) the adoption of the Merger Agreement and approval of the Merger, (ii) the approval of the related transactions contemplated by the Merger Agreement, (iii) to the extent applicable, the conversion of each share of Q32 preferred stock into shares of Q32 common stock immediately prior to and contingent upon the closing and (iv) the approval of certain additional proposals in connection with the Merger that the Q32 board of directors may recommend, including, if applicable, to approve any proposal to adjourn or postpone the meeting to a later date, if there are not sufficient votes for the adoption of the Merger Agreement on the date on which a meeting of such stockholders is held. These Q32 stockholders also agreed to vote against (i) any action or agreement that would result in a breach of any representation, warranty, covenant or obligation of Q32 in the Merger Agreement, (ii) any competing Acquisition Proposal with respect to Q32 and (iii) any agreement, transaction or other matter that is intended to, or would reasonably be expected to, impede, interfere with, delay, postpone, discourage or materially and adversely affect the Merger or any of the other transactions contemplated by the Merger Agreement, subject to certain specified exceptions.

These Q32 stockholders have also granted Q32 an irrevocable proxy to vote their respective shares of Q32 common stock or Q32 preferred stock in accordance with the support agreements. The Q32 stockholders may vote their shares of Q32 common stock or Q32 preferred stock on all other matters not referred to in such proxy.

As of October 31, 2023, the Q32 stockholders that are party to support agreements with Homology owned an aggregate of 1,693,680 shares of Q32 common stock and 84,305,730 shares of Q32 preferred stock, representing approximately 74.1% of the outstanding shares of Q32 common stock and Q32 preferred stock. These stockholders include executive officers and directors of Q32, as well as certain other stockholders owning a significant portion of the outstanding shares of Q32 capital stock. Following the effectiveness of the registration statement on Form S-4 of which this proxy statement/prospectus is a part and pursuant to the Merger Agreement, Q32 stockholders holding a sufficient number of shares of Q32 capital stock to adopt the Merger Agreement and approve the Merger and related transactions will execute written consents providing for such adoption and approval. Therefore, holders of a sufficient number of shares of Q32 capital stock required to adopt the Merger Agreement and approve the Merger and related transactions that are contractually obligated to adopt the Merger Agreement are expected to adopt the Merger Agreement via written consent.

Under these support agreements, subject to certain exceptions, such stockholders have also agreed not to sell or transfer their shares of Q32 capital stock and securities convertible into shares of Q32 capital stock held by them, or any voting rights with respect thereto, until the earlier of the termination of the Merger Agreement and the completion of the Merger, subject to certain exceptions. To the extent that any such sale or transfer is permitted pursuant to the exceptions included in the support agreement, each person to which any shares of Q32 capital stock or securities convertible into shares of Q32 capital stock are so sold or transferred must agree in writing to be bound by the terms and provisions of the support agreement.

In addition, in order to induce Q32 to enter into the Merger Agreement, certain Homology stockholders have entered into support agreements with Q32 pursuant to which, among other things, each such stockholder has agreed, solely in his, her or its capacity as a Homology stockholder, to vote all of his, her or its shares of Homology common stock in favor of (i) the approval of the Merger Agreement, (ii) the transactions contemplated thereby, including the issuance of Homology common stock to Q32 stockholders, (iii) an amendment to the restated certificate of incorporation of Homology to effect the proposed Reverse Stock Split, (iv) any proposal to adjourn or postpone the meeting to a later date, if there are not sufficient votes for the approval of the Merger Agreement and the transactions contemplated therein and (v) the approval of certain

 

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additional proposals in connection with the Merger that the Homology board of directors may recommend. These Homology stockholders also agreed to vote against (i) any action or agreement that would result in a breach of any representation, warranty, covenant or obligation of Homology in the Merger Agreement, (ii) any competing Acquisition Proposal with respect to Homology and (iii) any action, proposal, agreement, transaction or proposed transaction that would reasonably be expected to materially impede, interfere with, delay, postpone, discourage or adversely affect the Merger or any of the other transactions contemplated by the Merger Agreement, subject to certain specified exceptions.

These Homology Stockholders have also granted Q32 an irrevocable proxy to vote their respective shares of Homology common stock in accordance with the support agreements. Homology stockholders may vote their shares of Homology common stock on all other matters not referred to in such proxy.

As of November 30, 2023, the Homology stockholders that are party to a support agreement owned approximately 18.3% of the outstanding shares of Homology common stock. These stockholders include certain executive officers and directors of Homology.

Under these support agreements, subject to certain exceptions, such stockholders have also agreed not to sell or transfer their shares of Homology common stock and securities convertible into shares of Homology common stock held by them until the earlier of the termination of the Merger Agreement and the completion of the Merger, subject to certain exceptions. To the extent that any such sale or transfer is permitted pursuant to the exceptions included in the support agreements, each person to which any shares of Homology common stock or securities convertible into shares of Homology common stock are so sold or transferred must agree in writing to be bound by the terms and provisions of the support agreement.

The foregoing description of the support agreements does not purport to be complete and is qualified in its entirety by the full text of the forms of support agreements, which are attached hereto as Annex B and Annex C.

Lock-Up Agreements

Certain of Q32’s executive officers, directors and stockholders have entered into lock-up agreements, pursuant to which such parties have agreed not to, except in limited circumstances, offer, pledge, sell, contract to sell, sell any option to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, any shares of Homology’s common stock, including, as applicable, shares received in the Merger and shares issuable upon exercise of options, warrants or convertible securities, until 180 days after the Effective Time.

The Q32 stockholders who have executed lock-up agreements as of November 16, 2023, owned in the aggregate, approximately 74.1% of the outstanding shares of Q32 common stock and Q32 preferred stock.

Certain of Homology’s directors have entered into lock-up agreements, pursuant to which such stockholders have agreed not to, except in limited circumstances, offer, pledge, sell, contract to sell, sell any option to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, any Homology securities or shares of Homology common stock, including, as applicable, shares issuable upon exercise of certain options, warrants or convertible securities, until 180 days after the Effective Time.

Homology stockholders who have executed lock-up agreements as of November 30, 2023 owned, in the aggregate, less than 1% of the shares of outstanding Homology common stock.

The foregoing description of the lock-up agreements does not purport to be complete and is qualified in its entirety by the full text of the form of lock-up agreement, which is attached hereto as Annex E and Annex F.

 

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The Q32 Pre-Closing Financing

On November 16, 2023, concurrently with the execution and delivery of the Merger Agreement, Q32 entered into a subscription agreement, or the Subscription Agreement, with certain accredited investors named therein, or the investors, pursuant to which the investors agreed to purchase shares of Q32 common stock for aggregate gross proceeds of approximately $42.0 million to Q32, which private placement is referred to herein as the Pre-Closing Financing. The closing of the Pre-Closing Financing is conditioned upon the satisfaction or waiver of the conditions to the Merger as well as certain other conditions. Immediately after the Merger, the shares of Q32 common stock issued in the Pre-Closing Financing are expected to represent approximately 13.2% of the outstanding shares of the combined company. Q32 and the investors participating in the Pre-Closing Financing have also agreed to enter into the registration rights agreement at the closing of the Pre-Closing Financing, pursuant to which, among other things, the combined company will agree to provide for the registration and resale of certain shares of Homology common stock that are held by the investors participating in the Pre-Closing Financing from time to time.

Contingent Value Rights Agreement

CVR Agreement

As provided in the Merger Agreement and discussed under the section titled “The Merger Agreement —Contingent Value Rights” in this proxy statement/prospectus, Homology will declare a distribution to its common stockholders of record (determined as of the close of business on the last business day prior to the day on which the Effective Time occurs) the right to receive one CVR for each outstanding share of Homology common stock held by such stockholder as of such date, each representing the non-transferable contractual right to receive certain contingent payments from Homology upon the occurrence of certain events.

The CVRs will be governed by the terms of the CVR Agreement, which will be entered into at or prior to the Effective Time by Homology and Equiniti Trust Company, LLC, the Rights Agent.

Characteristics of the CVRs; Restrictions on Transfer

The CVRs may not be transferred, pledged, hypothecated, encumbered, assigned or otherwise disposed of (whether by sale, merger, consolidation, liquidation, dissolution, dividend, distribution or otherwise), in whole or in part, other than pursuant to any of the following permitted transfers: (i) upon death, by will or intestacy; (ii) by instrument to an inter vivos or testamentary trust in which the CVRs are to be passed to beneficiaries upon the death of the trustee; (iii) pursuant to a court order of a court of competent jurisdiction (such as in connection with divorce, bankruptcy or liquidation); (iv) by operation of law (including a consolidation or merger) or without consideration in connection with the dissolution, liquidation or termination of any corporation, limited liability company, partnership or other entity; (v) in the case of CVRs payable to a nominee, from a nominee to a beneficial owner (and, if applicable, through an intermediary) or from such nominee to another nominee for the same beneficial owner, in each case as permitted by The Depository Trust Company; (vi) to Homology or its subsidiaries; or (vii) upon abandonment of a CVR by the holder thereof in accordance with the CVR Agreement.

The CVRs will not be evidenced by a certificate or any other instrument. The CVRs will not have any voting or dividend rights, and interest will not accrue on any amounts payable in respect of the CVRs. The CVRs will not represent any equity or ownership interest in Homology, any constituent company to the Merger, or any of its subsidiaries. The Rights Agent will maintain an up-to-date register, or the CVR Register, for the purposes of (i) identifying the holders of CVRs, (ii) determining holders’ entitlement to CVRs, and (iii) registering the CVRs and permitted transfers thereof. Homology’s obligation to make the CVR payment, if any becomes due, is neither secured nor guaranteed by Homology or any of its subsidiaries.

CVR Payments

Pursuant to the CVR Agreement, each CVR holder is entitled to certain contingent cash payments, which are payable by Homology to the Rights Agent for subsequent distribution to the CVR holders (such payments,

 

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the CVR Payments), of the CVR Proceeds, which will equal the net amount (calculated in accordance with GAAP consistently applied) of:

 

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The cash proceeds actually received by Homology or its subsidiaries, collectively, the Gross Proceeds, as a result of the sale, transfer, license, assignment or other divestiture, disposition or commercialization of the following assets after the Closing and prior to the 18-month anniversary of the Closing (or prior to the 24-month anniversary of the Closing in the case of the of the Oxford Assets) (collectively, the “Legacy Assets”):

 

  •  

in respect of any equity interests held directly or indirectly by Homology in Oxford Biomedica Solutions LLC or its affiliates, or OXB Solutions, pursuant to that certain Equity Securities Purchase Agreement, dated as of January 28, 2022, by and between Homology and OXB Solutions, in which Homology currently owns twenty percent (20%) of the fully diluted equity interests in OXB Solutions and Homology is entitled to exercise a put option to sell or transfer Homology’s equity interests in OXB Solutions set forth therein on March 10, 2025 (such interests, the “Oxford Assets”); and

 

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in respect of HMI-103 (Adult/Pediatric PKU), HMI-204 (MLD) and Homology’s Capsids and AAVHSC Platform, including the Oxford Assets,

 

  •  

less all applicable reasonably documented permitted deductions, collectively, the Permitted Deductions, as of the date of payment, which include:

 

  •  

any applicable and non-recoverable value added, sales or similar taxes imposed upon the Gross Proceeds and payable in cash by Homology or any of its subsidiaries, certain income taxes required to be paid in cash as a result of the receipt of the Gross Proceeds;

 

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any documented out-of-pocket costs and expenses incurred by Homology or its subsidiaries in respect of its performance of the CVR Agreement, or in respect of its performance of any agreement, in connection with the Legacy Assets;

 

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any documented out-of-pocket costs and expenses incurred or accrued by Homology or its subsidiaries in respect of the negotiation, entry into or the closing of any sale, transfer, license, assignment or other divestiture, disposition or commercialization of the Legacy Assets during the Disposition Period, or a Legacy Asset Disposition;

 

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any losses incurred or reasonably expected to be incurred by Homology or its subsidiaries arising out of any third-party claims relating to or in connection with any Legacy Assets or any Legacy Asset Disposition, including the maximum amount that could be payable under any obligations of Homology or any of its subsidiaries (including contingent or indemnification obligations in connection with any agreement relating to any Legacy Asset Disposition), provided that any amounts deduced in respect of such contingent or indemnification obligations that have not been used to pay such contingent or indemnification obligations upon the lapse in survival of such obligations (or resolution of any dispute related to such obligations) prior to the tenth anniversary of the Closing Date will be paid over to the Rights Agent; and

 

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any liabilities borne by Homology or its subsidiaries pursuant to contracts related to the Legacy Assets, including costs arising from the termination thereof.

If a Legacy Asset Disposition is consummated:

 

  •  

on or prior to the closing date, then the proceeds from such disposition will be included in the calculation of Homology Net Cash pursuant to the Merger Agreement, which will have the effect of decreasing the number of shares issuable as consideration to the Q32 securityholders as of immediately prior to the Merger and proportionately increasing the relative ownership of the combined company by Homology securityholders as of immediately prior to the Merger; or

 

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  •  

following the closing date and for a period of ten years thereafter, then CVR holders will receive 100% of the CVR Proceeds, as a CVR Payment.

If any Gross Proceeds result from any Legacy Asset Disposition or from the ownership of equity securities in any subsidiary established by Homology during the Disposition Period, then CVR holders will receive 100% of the CVR Proceeds, as a CVR Payment, regardless of when such disposition is consummated.

Withholding

The CVR Agreement provides that Homology and the Rights Agent will be entitled to deduct and withhold, or cause to be deducted and withheld, from any payment payable to CVR holders pursuant to the CVR Agreement, such amounts as they are required to deduct and withhold with respect to the making of such payment under any provision of applicable law relating to taxes. To the extent that amounts are so deducted and withheld and paid over to the appropriate governmental authority, such deducted and withheld amounts will be treated for all purposes of the CVR Agreement as having been paid to the CVR holder in respect of which such deduction and withholding was made. Prior to making any such tax deductions or withholdings or causing any such tax deductions or withholdings to be made with respect to any CVR holder, the Rights Agent will, to the extent reasonably practicable, provide notice to the CVR holder of such potential tax deduction or withholding and a reasonable opportunity for the CVR holder to provide any necessary tax forms in order to avoid or reduce such withholding amounts. However, the time period for the payment of amounts payable to such CVR holder in accordance with the CVR Agreement will be extended by a period equal to any delay caused by the CVR holder in providing such forms, and in no event will such period be extended for more than ten business days (unless otherwise requested by the CVR holder for the purpose of delivering such forms and agreed to by the Rights Agent).

Payment Procedures

As promptly as practicable after CVR Proceeds are actually received, but no later than 45 days following the end of each fiscal quarter of Homology following the closing, Homology will (i) deliver to the Rights Agent an officer’s certificate certifying for such fiscal quarter the aggregate amount of (a) the CVR Proceeds received by Homology or its subsidiaries during such fiscal quarter (or in the case of the first delivery of such certificate, all CVR Proceeds received through the end of such fiscal quarter), (b) the Permitted Deductions reflected in such CVR Proceeds and (c) the CVR payment payable to the CVR holders, if any, and (d) deliver to the Rights Agent, or as the Rights Agent directs, the CVR payments (if any) by wire transfer of immediately transferable funds to an account designated by the Rights Agent. Upon receipt of the wire transfer referred to in the foregoing sentence, the Rights Agent shall promptly (and in any event, within ten business days) pay, by check mailed, first-class postage prepaid, to the address of each CVR holder set forth in the CVR Register at such time or by other method of delivery as specified by the applicable holder in writing to the Rights Agent, an amount equal to the product determined by multiplying (i) the quotient determined by dividing (A) the applicable CVR Payment by (B) the total number of CVRs registered in the CVR Register at such time, by (ii) the number of CVRs registered to such holder in the CVR Register at such time. For the avoidance of doubt Homology shall have no further liability in respect of the relevant CVR Payment upon delivery of such CVR Payment to the Rights Agent and the satisfaction of each of Homology’s obligations set forth hereunder.

CVR Special Committee

The CVR Agreement provides that the Homology board of directors shall have delegated to a special committee of Homology board of directors, or the CVR Special Committee, comprised of four (4) directors of the Homology board the sole responsibility, authority and discretion during the Disposition Period, with respect to (i) managing the Legacy Assets and (ii) negotiating any Legacy Asset Disposition during the Disposition Period, provided that the special committee may not cause Q32 to incur costs, expenses or obligations in excess of an amount specified in the CVR Agreement without the prior written consent of the Homology board of

 

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directors. The CVR Special Committee shall also be empowered with the authority to authorize and direct any officer of Homology to negotiate, execute and deliver a definitive written agreement with respect to any Legacy Asset in the name and on behalf of Homology, provided that no such agreement shall be entered into without the approval of the Homology board of directors (such approval not to be unreasonably withheld, conditioned or delayed).

During the six months immediately following the Closing Date, Homology will, and will cause its subsidiaries to, use commercially reasonable efforts to effect dispositions of the then-existing Legacy Assets (i) pursuant to a letter of intent for such Legacy Asset Disposition that was executed prior to the Closing Date, and (ii) to a third party that has delivered a bona fide indication of interest to Homology subsequent to the Closing Date, provided that such obligation will not apply to the Oxford Assets. Homology will use commercially reasonable efforts to exercise the put option in the Oxford Assets contemplated by the Amended and Restated Limited Liability Company Agreement, dated March 10, 2022, by and among Oxford Biomedica Solutions LLC (f/k/a Roadrunner Solutions LLC), Homology and Oxford Biomedica (US) Inc., promptly after such put option becomes exercisable on March 10, 2025.

During the Disposition Period, if and to the extent the CVR Special Committee recommends, and the Homology board of directors authorizes and directs, the execution and delivery of a definitive written agreement with respect to any Legacy Asset, Homology will, and will cause its subsidiaries to, use commercially reasonable efforts to effectuate the disposition of such Legacy Asset(s) pursuant to such agreement in accordance with its terms. Unless approved by the CVR Special Committee, Homology will have no obligation to enter into any sale agreement or other agreement in connection with a Legacy Asset Disposition that imposes on Homology or requires Homology to retain or assume, any material obligations or liabilities, monetary or otherwise, following the consummation of such transaction.

Following the Disposition Period, Homology will be permitted to take any action in respect of the Legacy Assets in order to satisfy any liabilities of or arising from the Legacy Assets, including any wind-down or termination costs of the Legacy Assets.

Amendment and Termination of the CVR Agreement

Homology may, at any time and from time to time, unilaterally enter into one or more amendments to the CVR Agreement for any of the following purposes, without the consent of any of the holders of CVRs or the Rights Agent:

 

  •  

to evidence the appointment of another person as a successor Rights Agent and the assumption by any successor Rights Agent of the covenants and obligations of the Rights Agent pursuant to the CVR Agreement;

 

  •  

to evidence the succession of another person to Homology and the assumption of any such successor of the covenants of Homology pursuant to the CVR Agreement;

 

  •  

to add to the covenants of Homology further covenants, restrictions, conditions or provisions for the protection and benefit of the holders of CVRs, provided that in each case, such provisions shall not adversely affect the interests of the holders of CVRs;

 

  •  

to cure any ambiguity, to correct or supplement any provision in the CVR Agreement that may be defective or inconsistent with any other provision in the CVR Agreement, or to make any other provisions with respect to matters or questions arising under the CVR Agreement, provided that in each case, such provisions shall not adversely affect the interests of the holders of CVRs;

 

  •  

as may be necessary or appropriate to ensure that CVRs are not subject to registration under the Securities Act or the Exchange Act and the rules and regulations made thereunder, or any applicable state securities or “blue sky” laws;

 

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  •  

as may be necessary or appropriate to ensure that Homology is not required to produce a prospectus or an admission document in order to comply with applicable law;

 

  •  

to cancel CVRs (i) in the event that any holder of CVRs has abandoned its rights to such CVRs or (ii) following a transfer of such CVRs to Homology or its subsidiaries;

 

  •  

as may be necessary or appropriate to ensure that Homology complies with applicable law; or

 

  •  

to effect any other amendment to the CVR Agreement that would provide any additional rights or benefits to the holders of CVRs or that does not adversely affect the legal rights under the CVR Agreement of any such holder of CVRs.

With the consent of the holders of not less than a majority of the outstanding CVRs, Homology and the Rights Agent may enter into any amendment to the CVR Agreement, even if such amendment is adverse to the interests of the holders of the CVRs.

Homology will (or will cause the Rights Agent to) provide notice in general terms of the substance of any amendment to the CVR Agreement to the holders of the CVRs promptly after execution by Homology and the Rights Agent, if applicable, of such amendment.

The CVR Agreement will automatically terminate and of no force or effect, and the parties will have no liability thereunder, upon the tenth anniversary of the closing date. 

Other Provisions of the CVR Agreement

The CVR Agreement also provides, among other things, for:

 

  •  

the duties, responsibilities, rights and immunities of the Rights Agent, and procedures for the resignation or removal of the Rights Agent and appointment of a successor;

 

  •  

a prohibition on Homology granting any lien, security, interest, pledge or similar interest in any Legacy Asset or any CVR Proceeds, unless approved by the CVR Special Committee; and

 

  •  

the application of laws of the State of Delaware, exclusive jurisdiction over the parties by the Chancery Court of the State of Delaware, County of New Castle, or, if under applicable law exclusive jurisdiction is vested in the Federal courts, the United States District Court for the District of Delaware (and appellate courts thereof), and waiver of trial by jury.

The foregoing description of the CVR Agreement does not purport to be complete and is qualified in its entirety by the full text of the form of CVR Agreement, which is attached hereto as Annex D.

Material U.S. Federal Income Tax Consequences of the CVRs to Holders of Homology Common Stock

The following discussion is a summary of the material U.S. federal income tax consequences of the issuance of the CVRs and payments (if any) thereon to holders of Homology common stock, but does not purport to be a complete analysis of all potential tax effects. The effects of other U.S. federal tax laws, such as estate and gift tax laws, and any applicable state, local, or non-U.S. tax laws are not discussed. Furthermore, the following discussion does not address any tax consequences of transactions effectuated before, after or at the same time as the distribution of the CVRs (except, to the limited extent discussed below, the Reverse Stock Split), whether or not they are in connection with the distribution of the CVRs. The CVRs generally may not be transferred or assigned except for certain permitted transfers; accordingly, this discussion assumes the CVRs are not transferable or assignable and does not address any consequences of transferring, assigning or otherwise disposing of the CVRs or any interest therein.

This discussion is based on the Code, Treasury Regulations promulgated thereunder, judicial decisions, and published rulings and administrative pronouncements of the IRS, in each case, as in effect as of the date hereof.

 

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These authorities may change or be subject to differing interpretations. Any such change or differing interpretation may be applied retroactively in a manner that could adversely affect a holder of Homology common stock. Homology has not sought and will not seek an opinion of counsel or any rulings from the IRS regarding the matters discussed below. There can be no assurance the IRS or a court will not take a contrary position to that discussed below regarding the tax consequences of the issuance of the CVRs and payments (if any) thereon.

This discussion is limited to holders of Homology common stock who hold their Homology common stock as a “capital asset” within the meaning of Section 1221 of the Code (generally, property held for investment). This discussion does not address all U.S. federal income tax consequences relevant to the particular circumstances of a holder of Homology common stock, including the impact of the Medicare contribution tax on net investment income and the alternative minimum tax. In addition, it does not address consequences relevant to holders of Homology common stock that are subject to particular rules, including, without limitation:

 

  •  

U.S. expatriates or former citizens or long-term residents of the United States;

 

  •  

U.S. Holders (as defined below) whose functional currency is not the U.S. dollar;

 

  •  

persons holding Homology common stock as part of a hedge, straddle, or other risk-reduction strategy or as part of a conversion transaction or other integrated investment;

 

  •  

banks, insurance companies, and other financial institutions;

 

  •  

real estate investment trusts or regulated investment companies;

 

  •  

brokers, dealers, or traders in securities;

 

  •  

S corporations, partnerships, or other entities or arrangements treated as pass-through entities for U.S. federal income tax purposes (and investors therein);

 

  •  

tax-exempt organizations, qualified retirement plans, individual retirement accounts or other tax deferred accounts, or governmental organizations;

 

  •  

persons deemed to sell Homology common stock under the constructive sale provisions of the Code;

 

  •  

persons who hold or receive Homology common stock pursuant to the exercise of any employee stock options or otherwise as compensation;

 

  •  

controlled foreign corporations, passive foreign investment companies, and corporations that accumulate earnings to avoid U.S. federal income tax;

 

  •  

“qualified foreign pension funds” as defined in Section 897(l)(2) of the Code and entities all of the interests of which are held by one or more qualified foreign pension funds; and

 

  •  

persons subject to special tax accounting rules as a result of any item of gross income with respect to the Homology common stock or the CVRs being taken into account in an applicable financial statement.

If a partnership, or an entity treated as a partnership for U.S. federal income tax purposes, holds Homology common stock, the tax treatment of a partner in the partnership will depend on the status of the partner, the activities of the partnership, and certain determinations made at the partner level. Accordingly, partnerships holding Homology common stock and the partners in such partnerships should consult their tax advisors regarding the U.S. federal income tax consequences to them.

THIS DISCUSSION IS NOT TAX ADVICE. HOLDERS OF HOMOLOGY COMMON STOCK SHOULD CONSULT THEIR TAX ADVISORS WITH RESPECT TO THE APPLICATION OF THE U.S. FEDERAL INCOME TAX LAWS TO THEIR PARTICULAR SITUATIONS AS WELL AS ANY TAX CONSEQUENCES OF THE ISSUANCE OF THE CVRS, AND PAYMENTS (IF ANY) THEREON,

 

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ARISING UNDER OTHER U.S. FEDERAL TAX LAWS (INCLUDING ESTATE AND GIFT TAX LAWS), UNDER THE LAWS OF ANY STATE, LOCAL, OR NON-U.S. TAXING JURISDICTION OR UNDER ANY APPLICABLE TAX TREATY.

Material U.S. Federal Income Tax Consequences for U.S. Holders

For purposes of this discussion, a “U.S. Holder” is any beneficial owner of Homology common stock that, for U.S. federal income tax purposes, is or is treated as:

 

  •  

an individual who is a citizen or resident of the United States;

 

  •  

a corporation created or organized in or under the laws of the United States, any state thereof, or the District of Columbia;

 

  •  

an estate, the income of which is subject to U.S. federal income tax regardless of its source; or

 

  •  

a trust that (1) is subject to the primary supervision of a U.S. court and all substantial decisions of which are subject to the control of one or more “United States persons” (within the meaning of Section 7701(a)(30) of the Code), or (2) has a valid election in effect to be treated as a United States person for U.S. federal income tax purposes.

Tax Treatment of the CVRs and the Proposed Reverse Stock Split

Although the matter is not free from doubt, Homology intends to treat the issuance of the CVRs (together with any payments on the CVRs) and the proposed Reverse Stock Split as separate transactions for U.S. federal income tax purposes, and the following discussion (except as discussed below under “—Alternative Treatment of the CVRs and the Reverse Stock Split as a Single Recapitalization”) assumes this treatment will be respected. The IRS could successfully challenge this position, however. Homology urges you to consult your tax advisor with respect to whether the issuance of the CVRs (and any payments on the CVRs), on the one hand, and the proposed Reverse Stock Split, on the other, constitute separate transactions.

Tax Treatment of the CVRs

There is no authority that directly addresses whether contingent value rights with characteristics similar to the CVRs should be treated for federal income tax purposes as a distribution of property with respect to Homology stock, an “open transaction,” or in some other manner, and such questions are inherently factual in nature. Accordingly, holders are urged to consult with their tax advisors regarding this issue.

However, based on the specific characteristics of the CVRs, and unless otherwise required by a change in law after the date of the CVR Agreement, Homology intends to take the position that the fair market value of the CVRs cannot be reasonably ascertained on the date of the issuance of the CVRs, or the CVR Distribution Date, and, accordingly, the issuance of the CVRs constitutes an “open transaction.” Accordingly, absent a change in law requiring otherwise, the combined company will not report the issuance of the CVRs as a current distribution of property with respect to its stock and will instead report each future cash payment (if any) on the CVRs as a distribution by the combined company for U.S. federal income tax purposes, with each such payment being reported as a dividend to the extent of the combined company’s current and accumulated earnings and profits in the year in which such payment is made.

If Homology’s intended reporting position is correct, a U.S. Holder would generally not recognize income in respect of the CVRs on the CVR Distribution Date and would take no tax basis in the CVRs. Any future cash payments would constitute a dividend to the extent of Homology’s current and accumulated earnings and profits (as determined for U.S. federal income tax purposes) in the taxable year of such payment, then as a non-taxable return of capital to the extent of such holder’s basis in its Homology common stock, and finally as capital gain from the sale or exchange of Homology common stock. Dividends received by individual U.S. Holders are generally eligible for reduced rates of taxation applicable to long-term capital gains, provided certain requirements are met.

 

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However, the IRS could instead assert that the issuance of the CVRs should be treated as a “closed transaction.” Under “closed transaction” treatment, a U.S. Holder would be treated as receiving a distribution equal to the fair market value (determined on the CVR Distribution Date) of the CVRs issued to such U.S. Holder on the CVR Distribution Date. The amount of this distribution generally would be treated first as a taxable dividend to the extent of the U.S. Holder’s pro rata share of Homology’s current or accumulated earnings and profits (as determined for U.S. federal income tax purposes), then as a non-taxable return of capital to the extent of the U.S. Holder’s basis in its Homology common stock, and finally as capital gain from the sale or exchange of Homology common stock. A U.S. Holder’s tax basis in the CVRs received would equal the fair market value of the CVRs on the CVR Distribution Date and the holding period of the CVRs received would begin on the day following the CVR Distribution Date. Although not free from doubt, a future cash payment under a CVR would likely be treated as a non-taxable return of a U.S. Holder’s adjusted tax basis in the CVR to the extent thereof, although the timing of the recovery of a U.S. Holder’s tax basis is unclear. A payment in excess of such amount may be treated as a payment with respect to a sale of a capital asset, ordinary income or a dividend. Additionally, it is possible that a portion of future cash payments would constitute imputed interest and taxed as such. A U.S. Holder might recognize loss, which might be a capital loss and could be a long-term capital loss, upon the expiration of the CVR to the extent cash payments ultimately received pursuant to such CVR were less than the U.S. Holder’s adjusted tax basis in the CVRs, but whether and when such a loss would be recognized is unclear. The deductibility of capital losses is subject to limitations.

It is possible, although Homology believes unlikely, that the issuance of the CVRs could be treated as one or more “debt instruments” or as a distribution of equity.

U.S. Holders are urged to consult their tax advisors with respect to the proper characterization of the CVRs and the tax consequences thereof (including any future cash payments made under the CVRs).

Alternative Treatment of the CVRs and the Proposed Reverse Stock Split as a Single Recapitalization

Notwithstanding Homology’s position that the CVRs and the proposed Reverse Stock Split are appropriately treated as separate transactions, it is possible that the IRS or a court could determine that the issuance of the CVRs (and/or any payments thereon) and the proposed Reverse Stock Split constitute a single “recapitalization” for U.S. federal income tax purposes with the CVRs constituting taxable “boot” received in such recapitalization exchange. In such case, the tax consequences of the CVRs and the proposed Reverse Stock Split would differ from those described above, including the timing and character of income, which would depend in part on many of the same considerations described above.

DUE TO THE SUBSTANTIAL UNCERTAINTY REGARDING THE TAX TREATMENT OF THE CVRS (AND ANY FUTURE CASH PAYMENTS UNDER THE CVRS) AND THE POSSIBLE INTEGRATION OF THE CVRS AND THE PROPOSED REVERSE STOCK SPLIT, U.S. HOLDERS ARE URGED TO CONSULT THEIR TAX ADVISORS CONCERNING THE RECOGNITION OF GAIN, INCOME AND/OR LOSS IN CONNECTION WITH THE CVRS AND THE PROPOSED REVERSE STOCK SPLIT AND THE APPLICABILITY OF INFORMATION REPORTING AND BACKUP WITHHOLDING.

Material U.S. Federal Income Tax Consequences for Non-U.S. Holders

The discussion below applies to beneficial owners of Homology common stock that are not U.S. Holders or entities treated as partnerships or other pass-through entities for U.S. federal income tax purposes (such beneficial owners, Non-U.S. Holders).

As discussed above under “Material U.S. Federal Income Tax Consequences for U.S. Holders—Tax Treatment of the CVRs and the Proposed Reverse Stock Split” and “Material U.S. Federal Income Tax Consequences for U.S. Holders—Tax Treatment of the CVRs,” Homology intends to take the position that any

 

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future cash payments on the CVRs are distributions with respect to Homology common stock and that such distributions constitute dividends to the extent payable out of Homology’s current and accumulated earnings and profits (as determined under U.S. federal income tax principles) in the taxable year of such future cash payment. Assuming such position is correct, amounts not treated as dividends for U.S. federal income tax purposes would constitute a return of capital and first be applied against and reduce a Non-U.S. Holder’s adjusted tax basis in its common stock, but not below zero, and any excess would be treated as capital gain with respect to such Non-U.S. Holder’s Homology common stock. However, this intended position is subject to substantial uncertainty, and, accordingly, Non-U.S. Holders are urged to consult their tax advisors with respect to the proper characterization of the CVRs and the tax consequences thereof (including any future cash payments made under the CVRs).

In light of Homology’s intended reporting position, it is expected that Non-U.S. Holders would generally be subject to U.S. federal withholding tax at a rate of 30% on any future cash payments on the CVRs. Such withholding may be reduced or eliminated if the Non-U.S. Holder properly certifies qualification for a lower withholding rate under an applicable tax treaty or an exemption from withholding as a result of dividends on the Homology common stock being effectively connected with the Non-U.S. Holder’s conduct of a trade or business within the United States (and, if required by an applicable tax treaty, the Non-U.S. Holder maintains a permanent establishment in the United States to which such dividends are attributable). A Non-U.S. Holder that is a corporation also could be subject to a branch profits tax at a rate of 30% (or such lower rate specified by an applicable tax treaty) on income attributable to the CVRs.

DUE TO THE LEGAL AND FACTUAL UNCERTAINTY REGARDING THE TAX TREATMENT OF THE CVRS (AND ANY FUTURE CASH PAYMENTS UNDER THE CVRS), NON-U.S. HOLDERS ARE URGED TO CONSULT THEIR TAX ADVISORS CONCERNING THE RECOGNITION OF GAIN, INCOME AND/OR LOSS OR WITHHOLDING THAT MAY APPLY IN CONNECTION WITH THE CVRS. NON-U.S. HOLDERS SHOULD CONSULT THEIR TAX ADVISORS REGARDING THE APPLICABILITY OF INFORMATION REPORTING AND BACKUP WITHHOLDING AND/OR WITHHOLDING UNDER THE FOREIGN ACCOUNT TAX COMPLIANCE ACT WITH RESPECT TO THE CVRS AND ANY FUTURE CASH PAYMENTS UNDER THE CVRS, PARTICULARLY IN LIGHT OF THE UNCERTAINTY UNDER U.S. FEDERAL INCOME TAX LAW RELATING TO THE TAX TREATMENT OF THE CVRS.

 

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MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES OF THE MERGER

The following discussion is a summary of the material U.S. federal income tax consequences for certain holders of Q32 common stock that exchange, pursuant to the Merger, their Q32 common stock for Homology common stock. The effects of other U.S. federal tax laws, such as estate and gift tax laws, and any applicable state, local, or non-U.S. tax laws are not discussed. This discussion is based on the Code, Treasury Regulations promulgated thereunder, judicial decisions, and published rulings and administrative pronouncements of the IRS, in each case, as in effect as of the date hereof. These authorities may change or be subject to differing interpretations. Any such change may be applied retroactively in a manner that could adversely affect a holder of Q32 common stock. Neither Homology nor Q32 has sought or will seek an opinion of counsel or any rulings from the IRS regarding the matters discussed below.

This discussion is limited to holders of Q32 common stock who hold their Q32 common stock as a “capital asset” within the meaning of Section 1221 of the Code (generally, property held for investment). In addition, this discussion does not address (a) all U.S. federal income tax consequences relevant to the particular circumstances of a stockholder of Q32 common stock, including the impact of the Medicare contribution tax on net investment income and the alternative minimum tax, (b) the tax consequences of transactions effectuated before, after or at the same time as the Merger, whether or not they are in connection with the Merger, including, without limitation, transactions in which shares of Q32 common stock are acquired or disposed of other than in exchange for shares of Homology common stock in the Merger; (c) the tax consequences to holders of Q32 convertible notes, or options or warrants issued by Q32 which are assumed in connection with the Merger; (c) the tax consequences of the ownership of shares of Homology common stock following the Merger; or (d) consequences relevant to holders of Q32 common stock that are subject to particular rules, including, without limitation:

 

  •  

brokers, dealers, or traders;

 

  •  

U.S. holders (as defined below) whose functional currency is not the U.S. dollar;

 

  •  

tax-exempt organizations, qualified retirement plans, individual retirement accounts or other tax deferred accounts, or governmental organizations;

 

  •  

banks or other financial institutions, underwriters, insurance companies, real estate investment trusts or regulated investment companies;

 

  •  

U.S. expatriates or former citizens or long-term residents of the United States;

 

  •  

persons that own (directly, indirectly, or by attribution) 5% or more (by vote or value) of the stock of Q32 prior to the Merger or of Homology after the Merger (except as specifically addressed herein);

 

  •  

S corporations, partnerships or other pass-through entities or arrangements for U.S. federal income tax purposes or beneficial owners of partnerships or other pass-through entities or arrangements;

 

  •  

persons holding Q32 common stock as part of a straddle, hedging or conversion transaction, constructive sale, or other arrangement involving more than one position;

 

  •  

persons subject to special tax accounting rules as a result of any item of income relating to Q32 common stock being recognized on an applicable financial statement;

 

  •  

U.S. Holders (as defined below) that hold Q32 common stock in connection with a trade or business conducted outside the United States;

 

  •  

persons that hold or received Q32 common stock pursuant to the exercise of any employee stock option or otherwise as compensation for services;

 

  •  

U.S. Holders of Q32 common stock that hold such stock as Section 306 stock (within the meaning of Section 306(c) of the Code);

 

  •  

“qualified foreign pension funds” as defined in Section 897(l)(2) of the Code and entities all of the interests of which are held by one or more qualified foreign pension funds; and

 

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  •  

controlled foreign corporations, passive foreign investment companies, and corporations that accumulate earnings to avoid U.S. federal income tax.

If a partnership, or an entity treated as a partnership for U.S. federal income tax purposes, holds Q32 common stock, the tax treatment of a partner in the partnership will depend on the status of the partner, the activities of the partnership, and certain determinations made at the partner level. Accordingly, partnerships holding Q32 common stock and the partners in such partnerships should consult their tax advisors regarding the U.S. federal income tax consequences to them.

THIS DISCUSSION IS NOT TAX ADVICE. HOLDERS OF Q32 STOCK SHOULD CONSULT THEIR TAX ADVISORS WITH RESPECT TO THE APPLICATION OF THE U.S. FEDERAL INCOME TAX LAWS TO THEIR PARTICULAR SITUATIONS AS WELL AS ANY TAX CONSEQUENCES OF THE MERGER ARISING UNDER OTHER U.S. FEDERAL TAX LAWS (INCLUDING ESTATE AND GIFT TAX LAWS), UNDER THE LAWS OF ANY STATE, LOCAL, OR NON-U.S. TAXING JURISDICTION OR UNDER ANY APPLICABLE TAX TREATY.

It is intended that the Merger shall qualify as a “reorganization” within the meaning of Section 368(a) of the Code and the Treasury Regulations promulgated thereunder. The parties to the Merger Agreement have agreed to report the Merger as qualifying as a “reorganization” within the meaning of Section 368(a) of the Code for U.S. federal income tax purposes.

The closing of the Merger is not conditioned upon the receipt of an opinion of counsel or a ruling from the IRS regarding the U.S. federal income tax treatment of the Merger, and no opinion of counsel or ruling from the IRS has been or will be requested regarding such treatment. Accordingly, there can be no assurance that the IRS will not challenge the qualification of the Merger as a “reorganization” within the meaning of Section 368(a) of the Code or that a court will not sustain such a challenge by the IRS. The remainder of this summary assumes that the Merger qualifies as a “reorganization” within the meaning of Section 368(a) of the Code.

Material U.S. Federal Income Tax Consequences for U.S. Holders

For purposes of this discussion, a “U.S. Holder” is any beneficial owner of Q32 common stock that, for U.S. federal income tax purposes, is or is treated as:

 

  •  

an individual who is a citizen or resident of the United States;

 

  •  

a corporation created or organized in or under the laws of the United States, any state thereof, or the District of Columbia;

 

  •  

an estate, the income of which is subject to U.S. federal income tax regardless of its source; or

 

  •  

a trust that (1) is subject to the primary supervision of a U.S. court and all substantial decisions of which are subject to the control of one or more “United States persons” (within the meaning of Section 7701(a)(30) of the Code), or (2) has a valid election in effect to be treated as a United States person for U.S. federal income tax purposes.

The Merger

If the Merger qualifies as a “reorganization” within the meaning of Section 368(a) of the Code, a U.S. Holder that exchanges shares of Q32 common stock in the Merger for Homology common stock generally should not recognize any gain or loss on such exchange. In such case, the aggregate adjusted tax basis of the Homology common stock received in the Merger by a U.S. Holder should be equal to the adjusted tax basis of the Q32 common stock surrendered in the Merger in exchange therefor and the holding period of the Homology common stock should include the holding period during which the Q32 common stock surrendered in the Merger in exchange therefor.

 

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If the Merger does not qualify as a “reorganization” within the meaning of Section 368(a) of the Code, a U.S. Holder that exchanges Q32 common stock in the Merger for Homology common stock generally would be required to recognize gain or loss equal to the difference, if any, between (i) the fair market value as of the Effective Time of the Homology common stock received by such U.S. Holder and (ii) such U.S. Holder’s adjusted tax basis in the Q32 common stock exchanged therefor. Such gain or loss would be capital gain or loss and generally would be long-term capital gain or loss if the U.S. Holder’s holding period for such shares of Q32 common stock exceeds one year. Net short-term capital gain generally is taxed at regular ordinary income tax rates. Long-term capital gain recognized by non-corporate U.S. Holders may be taxed at reduced rates. The deductibility of capital losses is subject to limitations. A U.S. Holder would have an aggregate tax basis in any Homology common stock received in the Merger that is equal to the fair market value of such Homology common stock as of the Effective Time, and the holding period of such Homology common stock would begin on the day following the Merger.

The Homology common stock received in the Merger by a U.S. Holder that acquired different blocks of Q32 common stock at different times or at different prices will be allocated pro rata to each block of Q32 common stock of such U.S. Holder, and the basis and holding period of such shares of Homology common stock will be determined using a block for block approach and will depend on the basis and holding period of each block of Q32 common stock exchanged for such Homology common stock.

Material U.S. Federal Income Tax Consequences for Non-U.S. Holders

The discussion below applies to beneficial owners of Homology common stock that are not U.S. Holders or entities or arrangements treated as partnerships or other pass-through entities for U.S. federal income tax purposes (such beneficial owners, Non-U.S. Holders).

In general, the U.S. federal income tax consequences relating to the Merger for a Non-U.S. Holder that exchanges its shares of Q32 common stock for Homology common stock in the Merger will be the same as those described above for a U.S. Holder, except that, even if the Merger did not qualify as a “reorganization” within the meaning of Section 368(a) of the Code, a Non-U.S. Holder generally will not be subject to U.S. federal income tax on any gain realized in connection with the Merger unless:

 

  •  

such gain is effectively connected with the Non-U.S. Holder’s conduct of a trade or business within the United States (and, if required by an applicable tax treaty, is attributable to a permanent establishment of the Non-U.S. Holder in the United States);

 

  •  

the Non-U.S. Holder is an individual who is present in the United States for a period or periods aggregating 183 days or more in the taxable year in which the Merger occurs and certain other conditions are met; or

 

  •  

shares of Q32 common stock constituted a “United States real property interest”, or a USRPI, by reason of Q32’s status as a “United States real property holding corporation”, or a USRPHC, for U.S. federal income tax purposes at any time during the shorter of the five-year period ending on the date of the Merger or the period that such Non-U.S. Holder held shares of Q32 common stock.

Gain described in the first bullet point above generally will be subject to U.S. federal income tax on a net income basis at the regular U.S. federal income tax rates in the same manner as if such Non-U.S. Holder were a U.S. Holder. A Non-U.S. Holder that is a corporation also may be subject to an additional branch profits tax at a rate of 30% (or such lower rate as may be specified by an applicable tax treaty) on its effectively connected earnings and profits for the taxable year, subject to certain adjustments.

A Non-U.S. Holder described in the second bullet point above will be subject to U.S. federal income tax with respect to such gain at a 30% rate (or such lower rate as may be specified by an applicable tax treaty), which may be offset by such Non-U.S. Holder’s U.S. source capital losses, if any, provided the Non-U.S. Holder has timely filed U.S. federal income tax returns with respect to such losses.

 

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With respect to the third bullet point above, Q32 does not believe it is, or has been during the five-year period ending on the date of the Merger, a USRPHC.

Non-U.S. Holders should consult their tax advisors regarding the potential application of tax treaties that may provide for different rules with respect to any gain recognized by a Non-U.S. Holder.

Reporting Requirements

If the Merger qualifies as a “reorganization” within the meaning of Section 368(a) of the Code, each U.S. Holder that is a “significant transferor” must include a statement on or with such transferor’s U.S. federal income tax return for the taxable year of the Merger. For this purpose, a significant transferor is generally a person that transferred property to a corporation and received stock of the transferee corporation if, immediately after the exchange, such person (i) owns at least five percent (5%) (by vote or value) of the total outstanding stock of the transferee corporation if the stock owned by such person is publicly traded, or (ii) owned at least one percent (1%) (by vote or value) of the total outstanding stock of the transferee corporation if the stock owned by such person is not publicly traded. It is expected that the Homology common stock will be publicly traded for this purpose.

THE PRECEDING DISCUSSION IS INTENDED ONLY AS A SUMMARY OF CERTAIN U.S. FEDERAL INCOME TAX CONSEQUENCES RELATING TO THE MERGER. IT IS NOT A COMPLETE ANALYSIS OR DISCUSSION OF ALL POTENTIAL TAX EFFECTS THAT MAY BE IMPORTANT TO A PARTICULAR HOLDER OF SHARES OF Q32 COMMON STOCK. ALL HOLDERS OF SHARES OF Q32 COMMON STOCK ARE STRONGLY ENCOURAGED TO CONSULT THEIR TAX ADVISORS WITH RESPECT TO THE U.S. FEDERAL INCOME TAX CONSEQUENCES RELATING TO THE MERGER FOR THEM IN LIGHT OF THEIR PARTICULAR CIRCUMSTANCES, INCLUDING THE APPLICABILITY AND EFFECT OF TAX REPORTING REQUIREMENTS, AND THE APPLICABILITY AND EFFECT OF ANY OTHER U.S. FEDERAL TAX LAWS, AND U.S. STATE OR LOCAL, NON-U.S. OR OTHER TAX LAWS.

 

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THE SPECIAL MEETING OF HOMOLOGY STOCKHOLDERS

Date, Time and Place

The Homology Special Meeting will be held on         , 2024, commencing at              a.m. Eastern Time, unless postponed or adjourned to a later date. The Homology Special Meeting will be held entirely online. Homology is sending this proxy statement/prospectus to its stockholders in connection with the solicitation of proxies by Homology’s board of directors for use at the Homology Special Meeting and any adjournments or postponements of the Homology Special Meeting. This proxy statement/prospectus is first being sent to Homology stockholders on or about             , 2024.

Purposes of the Homology Special Meeting

The purpose of the Homology Special Meeting is:

 

  1.

To approve the issuance of shares of common stock of Homology to stockholders of Q32 pursuant to the terms of the Merger Agreement, a copy of which is attached as Annex A to this proxy statement/prospectus, pursuant to which Merger Sub will merge with and into Q32, with Q32 surviving as a wholly owned subsidiary of Homology, and the surviving corporation of the Merger, and the change of control resulting from the Merger, or the Stock Issuance Proposal;

 

  2.

To approve an amendment to the Restated Certificate of Incorporation of Homology, a copy of which is attached as Annex G to the accompanying proxy statement/prospectus, to increase the number of authorized shares of Homology common stock to 400,000,000, subject to the Homology board of directors’ authority to abandon such amendment, or the Authorized Share Increase Proposal;

 

  3.

To approve an amendment to the Restated Certificate of Incorporation of Homology, a copy of which is attached as Annex G to this proxy statement/prospectus, to effect a reverse stock split of Homology’s issued and outstanding common stock at a ratio ranging from any whole number between 1-for-            and 1-for-            , as determined by the Homology board of directors in its discretion, subject to the Homology board of directors’ authority to abandon such amendment, or the Reverse Stock Split Proposal;

 

  4.

To approve the 2024 Stock Option and Incentive Plan, a copy of which is attached as Annex I to the accompanying proxy statement/prospectus, or the Stock Option and Incentive Plan Proposal;

 

  5.

To approve the 2024 Employee Stock Purchase Plan, a copy of which is attached as Annex J to the accompanying proxy statement/prospectus, or the ESPP Proposal; and

 

  6.

To consider and vote upon an adjournment of the Homology Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of the Stock Issuance Proposal, the Authorized Share Increase Proposal and the Reverse Stock Split Proposal, or the Adjournment Proposal.

The Stock Issuance Proposal is a condition to completion of the Merger. The issuance of Homology common stock in connection with the Merger cannot take place unless the Stock Issuance Proposal is approved by the Homology stockholders. Approval of the Authorized Share Increase Proposal and the Reverse Stock Split Proposal, to amend Homology’s Restated Certificate of Incorporation to effect the Authorized Share Increase and the Reverse Stock Split, are also conditions to completion of the Merger. Therefore, the Merger cannot be consummated without the approval of the Stock Issuance Proposal, the Authorized Share Increase Proposal and the Reverse Stock Split Proposal.

Recommendation of the Homology Board of Directors

The Homology board of directors recommends that you vote:

 

  •  

FOR the approval of the issuance of shares of Homology common stock pursuant to terms of the Merger Agreement and the change of control resulting from the Merger, or the Stock Issuance Proposal.

 

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  •  

FOR the approval of an amendment to the Restated Certificate of Incorporation of Homology to effect the Authorized Share Increase, subject to the Homology board of directors’ authority to abandon such amendment, as described in this proxy statement/prospectus, or the Authorized Share Increase Proposal.

 

  •  

FOR the approval of an amendment to the Restated Certificate of Incorporation of Homology to effect the Reverse Stock Split, subject to the Homology board of directors’ authority to abandon such amendment, as described in this proxy statement/prospectus, or the Reverse Stock Split Proposal.

 

  •  

FOR the approval of the 2024 Stock Option and Incentive Plan.

 

  •  

FOR the approval of the 2024 Employee Stock Purchase Plan.

 

  •  

FOR the adjournment of the Homology Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes at the time of the Homology Special Meeting to approve the Stock Issuance Proposal, the Authorized Share Increase Proposal and the Reverse Stock Split Proposal, or the Adjournment Proposal.

Record Date and Voting Power

Only stockholders of record of Homology common stock at the close of business on the record date             , are entitled to notice of, and to vote at, the Homology Special Meeting. As of the Record Date, there were              stockholders of record and shares of Homology common stock issued and outstanding. Each share of Homology common stock entitles the stockholder thereof to one vote on each matter submitted for stockholder approval.

Voting and Revocation of Proxies

The proxy accompanying this proxy statement/prospectus is solicited on behalf of Homology’s board of directors for use at the Homology Special Meeting.

If, as of the Record Date, your shares were registered directly in your name with the transfer agent for Homology common stock, Equiniti Trust Company, LLC, then you are a stockholder of record. Whether or not you plan to attend the Homology Special Meeting online, Homology urges you to fill out and return the proxy card or vote over the telephone or on the Internet as instructed below to ensure your vote is counted.

The procedures for voting are as follows:

If you are a stockholder of record, you may vote at the Homology Special Meeting. Alternatively, you may vote by proxy by using the accompanying proxy card, over the Internet or by telephone. Whether or not you plan to attend the Homology Special Meeting, Homology encourages you to vote by proxy to ensure your vote is counted. Even if you have submitted a proxy before the Homology Special Meeting, you may still attend and participate in the Homology Special Meeting online by accessing              . In such case, your previously submitted proxy will be disregarded.

 

  •  

To vote at the Homology Special Meeting, attend the Homology Special Meeting online and follow the instructions posted at .

 

  •  

To vote using the proxy card, simply complete, sign and date the accompanying proxy card and return it promptly in the envelope provided. If you return your signed proxy card before the Homology Special Meeting, Homology will vote your shares in accordance with the proxy card.

 

  •  

To vote by proxy over the Internet at             , follow the instructions on the proxy card.

 

  •  

To vote by telephone by calling , follow the instructions on the proxy card.

 

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If you are a beneficial owner of shares registered in the name of your broker, bank or other nominee, you should have received a voting instruction card and voting instructions with these proxy materials from your broker, bank or other nominee. Simply complete and mail the voting instruction card to ensure that your vote is counted. To vote live at the Homology Special Meeting, you must obtain a valid proxy from your broker, bank or other nominee. Follow the instructions from your broker, bank or other nominee included with these proxy materials, or contact your broker, bank or other nominee to request a proxy form.

It is anticipated that all of the proposals currently scheduled for consideration at the Homology Special Meeting will be considered “non-routine” matters, and a broker will lack the authority to vote shares at its discretion on such proposals. If you are a beneficial owner and you do not instruct your bank, broker or other nominee on how to vote your shares, your bank, broker or other nominee may not vote your shares on any of the proposals, and your shares will not be represented and will not be voted on any matter.

All properly executed proxies that are not revoked will be voted at the Homology Special Meeting and at any adjournments or postponements of the Homology Special Meeting in accordance with the instructions contained in the proxy. If a holder of Homology common stock executes and returns a proxy and does not specify otherwise, the shares represented by that proxy will be voted “FOR” all of the proposals in accordance with the recommendation of Homology’s board of directors.

If you are a stockholder of record of Homology and you have not executed a support agreement, you may change your vote at any time before your proxy is voted at the Homology Special Meeting in any one of the following ways:

 

  •  

You may submit another properly completed proxy with a later date by mail or via the Internet.

 

  •  

You can provide your proxy instructions via telephone at a later date.

 

  •  

You may send a written notice that you are revoking your proxy to Homology’s Corporate Secretary at One Patriots Park, Bedford, MA 01730.

 

  •  

You may attend the Homology Special Meeting online and vote by following the instructions at . Simply attending the Homology Special Meeting will not, by itself, revoke your proxy.

If your shares are held by your broker, bank or other agent, you should follow the instructions provided by them.

If your shares are held in “street name” by a bank, broker or other nominee, you will receive instructions on how to vote from the bank, broker or other nominee. You must follow the instructions of such bank, broker or other nominee in order for your shares to be voted.

Required Vote

The presence, remote communication or represented by proxy, at the Homology Special Meeting of the stockholders of a majority in voting power of Homology capital stock issued and outstanding and entitled to vote at the Homology Special Meeting is necessary to constitute a quorum at the meeting. Abstentions and broker non-votes will be counted towards a quorum. The affirmative vote of the holders of a majority in voting power of the votes cast affirmatively or negatively at the Homology Special Meeting by the holders entitled to vote thereon, assuming a quorum is present, is required for approval of all of the proposals. Approval of the Stock Issuance Proposal, the Authorized Share Increase Proposal and the Reverse Stock Split Proposal is a condition to the completion of the Merger. Therefore, the Merger cannot be consummated without the approval of the Stock Issuance Proposal, the Authorized Share Increase Proposal and the Reverse Stock Split Proposal.

 

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The table below summarizes the proposals that will be voted on, the vote required to approve each item and how votes are counted:

 

Proposal

  

Votes Required

  

Voting Options

  

Impact of

“Withhold”

or

“Abstain”

Votes

Proposal No. 1:
Approval of the Issuance of Common Stock in the Merger and the Change of Control Resulting from the Merger
   The affirmative vote of the stockholders of a majority in voting power of the votes cast affirmatively or negatively at the Homology Special Meeting by the stockholders entitled to vote thereon.   

“FOR”

“AGAINST”            

“ABSTAIN”

   None(1)
Proposal No. 2:
Approval of the Amendment to the Restated Certificate of Incorporation of Homology Effecting the Authorized Share Increase
   The affirmative vote of the stockholders of a majority in voting power of the votes cast affirmatively or negatively at the Homology Special Meeting by the stockholders entitled to vote thereon.   

“FOR”

“AGAINST”

“ABSTAIN”

   None(1)
Proposal No. 3:
Approval of the Amendment to the Restated Certificate of Incorporation of Homology Effecting the Reverse Stock Split
   The affirmative vote of the stockholders of a majority in voting power of the votes cast affirmatively or negatively at the Homology Special Meeting by the stockholders entitled to vote thereon.   

“FOR”

“AGAINST”

“ABSTAIN”

   None(1)
Proposal No. 4: Approval of the 2024 Stock Option and Incentive Plan    The affirmative vote of the stockholders of a majority in voting power of the votes cast affirmatively or negatively at the Homology Special Meeting by the stockholders entitled to vote thereon.   

“FOR”

“AGAINST”

“ABSTAIN”

   None(1)
Proposal No. 5: Approval of the 2024 Employee Stock Purchase Plan    The affirmative vote of the stockholders of a majority in voting power of the votes cast affirmatively or negatively at the Homology Special Meeting by the stockholders entitled to vote thereon.   

“FOR”

“AGAINST”

“ABSTAIN”

   None(1)
Proposal No. 6: Approval of Adjournment of the Homology Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of Proposals Nos. 1 and 2    The affirmative vote of the stockholders of a majority in voting power of the votes cast affirmatively or negatively at the Homology Special Meeting by the stockholders entitled to vote thereon.   

“FOR”

“AGAINST”

“ABSTAIN”

   None(1)

 

(1)

A vote marked as an “Abstention” is not considered a vote cast and will, therefore, not affect the outcome of this proposal.

Certain stockholders of Homology have entered into stockholder support agreements pursuant to which they have agreed to vote all shares of Homology common stock owned by them as of the Record Date in favor of the Stock Issuance Proposal, the Authorized Share Increase Proposal and the Reverse Stock Split Proposal and against any competing “acquisition proposal” (as defined in the support agreements). As of the Record Date, the directors and certain executive officers of Homology owned or controlled     % of the outstanding shares of Homology common stock entitled to vote at the Homology Special Meeting.

 

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Solicitation of Proxies

In addition to solicitation by mail, the directors, officers, employees and agents of Homology may solicit proxies from Homology stockholders by personal interview, telephone, email, fax or otherwise. Homology will pay the cost of printing and filing of this proxy statement/prospectus and the proxy card. Arrangements will also be made with brokerage firms and other custodians, nominees and fiduciaries who are record holders of Homology common stock for the forwarding of solicitation materials to the beneficial owners of Homology common stock. Homology will reimburse these brokers, custodians, nominees and fiduciaries for the reasonable out-of-pocket expenses they incur in connection with the forwarding of solicitation materials. Homology has retained Morrow Sodali to assist it in soliciting proxies. Homology will pay the fees of Morrow Sodali, which Homology expects to be approximately $25,000, plus reimbursement of out-of-pocket expenses.

 

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MATTERS BEING SUBMITTED TO A VOTE OF HOMOLOGY STOCKHOLDERS

PROPOSAL NO. 1: APPROVAL OF THE ISSUANCE OF COMMON STOCK IN THE MERGER AND THE CHANGE OF CONTROL RESULTING FROM THE MERGER

At the Homology Special Meeting, Homology stockholders will be asked to approve the issuance of Homology common stock in the Merger. Immediately following the Merger, it is expected that the former Q32 securityholders will own approximately 75% of the fully-diluted common stock of Homology, with the Homology securityholders as of immediately prior to the Merger holding approximately 25% of the fully-diluted common stock of Homology, subject to certain assumptions, including, but not limited to, Homology’s net cash as of closing being equal to $60.0 million and Q32 issuing approximately $42.0 million of Q32 common stock in the Pre-Closing Financing described elsewhere in this proxy statement/prospectus.

The terms of, reasons for and other aspects of the Merger Agreement, the Merger and the issuance of Homology common stock in the Merger and securities of the combined company are described in detail in the other sections in this proxy statement/prospectus. A copy of the Merger Agreement is attached as Annex A to this proxy statement/prospectus.

Under Nasdaq Listing Rule 5635(a)(1), a company listed on Nasdaq is required to obtain stockholder approval prior to the issuance of common stock in connection with the acquisition of another company’s stock, if the number of shares of common stock to be issued will have, upon issuance, voting power equal to or in excess of 20% of the voting power of the shares of common stock outstanding before such issuance. The potential issuance of the shares of Homology common stock in the Merger exceeds the 20% threshold under Nasdaq Listing Rule 5635(a)(1) and is expected to represent approximately     % of the voting power of Homology common stock following the Merger. Accordingly, in order to ensure compliance with Nasdaq Listing Rule 5635(a)(1), Homology must obtain the approval of Homology stockholders for the issuance of the shares of common stock to be issued in the Merger.

Under Nasdaq Listing Rule 5635(b), a company listed on Nasdaq is required to obtain stockholder approval prior to an issuance of securities that will result in a “change of control” of the company. Although Nasdaq has not adopted any rule as to what constitutes a “change of control” for purposes of Rule 5635(b), Nasdaq has previously indicated that the acquisition of, or right to acquire, by a single investor or affiliated investor group, as little as 20% of the common stock (or securities convertible into or exercisable for common stock) or voting power of an issuer could constitute a change of control. Accordingly, in order to ensure compliance with Nasdaq Listing Rule 5635(b), Homology must obtain the approval of Homology stockholders of the change of control resulting from the Merger.

If Homology reasonably believes that (i) it will not receive proxies sufficient to obtain the required Homology stockholder vote, whether or not a quorum would be present or (ii) it will not have sufficient shares of Homology Common Stock represented to constitute a quorum necessary to conduct the business of the Homology Special Meeting, Homology may postpone or adjourn the Homology Special Meeting as long as the date of the Homology Special Meeting is not postponed or adjourned more than an aggregate of 30 days in connection with any postponements or adjustments. Homology current does not intend to propose postponement or adjournment at the Homology Special Meeting if there are sufficient votes to approve this proposal and the Authorized Share Increase Proposal and the Reverse Stock Split Proposal.

Required Vote

The affirmative vote of a majority in voting power of the votes cast affirmatively or negatively in attendance or represented by proxy at the Homology Special Meeting and entitled to vote on the matter is required to approve the issuance of Homology common stock in the Merger and the change of control of Homology resulting from the Merger.

 

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HOMOLOGY’S BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS A VOTE “FOR” THIS PROPOSAL NO. 1 TO APPROVE THE ISSUANCE OF HOMOLOGY COMMON STOCK IN THE MERGER AND THE CHANGE OF CONTROL OF HOMOLOGY RESULTING FROM THE MERGER.

Unless otherwise instructed, it is the intention of the persons named in the accompanying proxy card to vote shares represented by properly executed proxy cards “FOR” the approval of the issuance of Homology common stock in the Merger and the change of control of Homology resulting from the Merger.

 

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PROPOSAL NO. 2: APPROVAL OF THE AMENDMENT TO THE RESTATED CERTIFICATE OF INCORPORATION OF HOMOLOGY EFFECTING THE AUTHORIZED SHARE INCREASE

General

At the Homology Special Meeting, Homology stockholders will be asked to approve a proposal to adopt an amendment to the Restated Certificate of Incorporation of Homology to increase the number of authorized shares of Homology common stock from 200,000,000 shares to 400,000,000 shares.

The Restated Certificate of Incorporation of Homology currently authorizes 200,000,000 shares of common stock, par value $0.0001 per share, and 10,000,000 shares of preferred stock, par value $0.0001 per share, of which                  shares of common stock and no shares of preferred stock were outstanding as of                , the record date for the Homology Special Meeting. The proposed amendment to Restated Certificate of Incorporation of Homology would not increase or otherwise affect its authorized preferred stock. Homology common stock is all of a single class, with equal voting, distribution, liquidation and other rights. The additional Homology common stock to be authorized by adoption of the amendment would have rights identical to Homology’s currently outstanding common stock.

The form of the amendment to the Restated Certificate of Incorporation of Homology to increase the number of authorized shares of Homology common stock, which Homology’s board of directors approved and declared advisable on                     , is attached as Annex G to this proxy statement/prospectus. If Homology’s stockholders approve this proposal, subject to the discretion of Homology’s board of directors, Homology intends to file the amendment to the Restated Certificate of Incorporation of Homology with the Secretary of State of the State of Delaware prior to the Effective Time. In the event that Homology’s board of directors determines to effect the authorized share increase that is the subject of this Authorized Share Increase Proposal and the Reverse Stock Split that is the subject of the Reverse Stock Split Proposal, assuming that each proposal is approved by the Homology stockholders, Homology’s board of directors would effect the authorized share increase before effecting the Reverse Stock Split.

Background and Reasons for the Charter Amendment

As described in greater detail in the Stock Issuance Proposal, Homology will be required to issue shares of Homology common stock to Q32 stockholders pursuant to the terms of the Merger Agreement. In addition, if the Stock Option and Incentive Plan Proposal and the ESPP Proposal are approved, Homology will reserve additional shares of Homology common stock for future issuance under the 2024 Stock Option and Incentive Plan and the 2024 Employee Stock Purchase Plan. To the extent the Reverse Stock Split Proposal is approved and the Reverse Stock Split is implemented, the authorized shares of Homology will be proportionately reduced in accordance with the split to be determined in the discretion of Homology’s board of directors as described in greater detail in the Reverse Stock Split Proposal.

Homology’s board of directors believes that as a result of the foregoing, the number of authorized shares of Homology common stock that would be authorized and unissued and not reserved for issuance will not be an adequate number of shares to assure that there will be sufficient shares available for (i) the issuance of shares of Homology common stock to Q32 stockholders pursuant to the terms of the Merger Agreement, (ii) the issuance of shares of Homology common stock pursuant to the terms of the Merger Agreement, (iii) future issuance under the 2024 Stock Option and Incentive Plan, (iv) future issuance under the 2024 Employee Stock Purchase Plan and (v) the issuance of shares of Homology common stock underlying Homology options, including Homology ITM Options, and Homology Restricted Stock Units. In addition, there will not be sufficient shares available for issuance in connection with possible future acquisitions, equity and equity-based financings, possible future awards under employee benefit plans and other corporate purposes. Therefore, Homology’s board of directors has determined that it is in the best interests of Homology and its stockholders to amend the Restated Certificate of Incorporation of Homology as described herein.

 

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Except for (i) the issuance of shares of Homology common stock to Q32 stockholders pursuant to the terms of the Merger Agreement, which is the subject of the Stock Issuance Proposal and which is described elsewhere in this proxy statement/prospectus, (ii) the issuance of shares of Homology common stock pursuant to the terms of the Merger Agreement, which is described elsewhere in this proxy statement/prospectus, (iii) future issuance under the 2024 Stock Option and Incentive Plan, which is the subject of the Stock Option and Incentive Plan Proposal and which is described elsewhere in this proxy statement/prospectus, (iv) future issuance under the 2024 Employee Stock Purchase Plan, which is the subject of the ESPP Proposal and which is described elsewhere in this proxy statement/prospectus and (v) the issuance of shares of Homology common stock underlying Homology options, including Homology ITM Options, and Homology Restricted Stock Units, Homology does not currently have any plans, proposals or arrangement to issue any of its authorized but unissued shares of common stock.

Possible Effects of the Amendment

If the amendment to the Restated Certificate of Incorporation of Homology is approved, the additional authorized shares would be available for issuance at the discretion of Homology’s board of directors and without further stockholder approval, except as may be required by law or the rules of The Nasdaq Stock Market on which Homology common stock is listed. The additional shares of authorized common stock would have the same rights and privileges as the shares of Homology common stock currently issued and outstanding. Holders of Homology common stock have no preemptive rights.

The issuance of additional shares of Homology common stock may, among other things, have a dilutive effect on earnings per share and on stockholders’ equity and voting rights. Furthermore, future sales of substantial amounts of Homology common stock, or the perception that these sales might occur, could adversely affect the prevailing market price of Homology common stock or limit Homology’s ability to raise additional capital. Stockholders should recognize that, as a result of this proposal, they will own a smaller percentage of shares relative to the total authorized shares of the company than they presently own.

Required Vote

The affirmative vote of a majority in voting power of the votes cast affirmatively or negatively in attendance or represented by proxy at the Homology Special Meeting and entitled to vote on the matter is required to approve the amendment to the Restated Certificate of Incorporation of Homology effecting the Authorized Share Increase, subject to the Homology board of directors’ authority to abandon such amendment.

HOMOLOGY’S BOARD OF DIRECTORS RECOMMENDS A VOTE “FOR” THIS PROPOSAL NO. 2 TO APPROVE THE AMENDMENT TO THE RESTATED CERTIFICATE OF INCORPORATION EFFECTING THE AUTHORIZED SHARE INCREASE.

Unless otherwise instructed, it is the intention of the persons named in the accompanying proxy card to vote shares represented by properly executed proxy cards “FOR” the approval of the amendment to the Restated Certificate of Incorporation of Homology to effect the Authorized Share Increase.

 

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PROPOSAL NO. 3: APPROVAL OF THE AMENDMENT TO THE RESTATED CERTIFICATE OF INCORPORATION OF HOMOLOGY EFFECTING THE REVERSE STOCK SPLIT

The Homology board of directors has approved and, subject to stockholder approval, adopted a resolution (1) declaring advisable, and recommending to the Homology stockholders for their approval, an amendment to the Restated Certificate of Incorporation, to give the Homology’s board of directors discretionary authority to effect a Reverse Stock Split of Homology’s issued and outstanding common stock at a ratio ranging from any whole number between 1-for-                 and 1-for-                 , as determined by the Homology board of directors in its discretion, subject to the Homology board of directors’ authority to determine when to file the amendment and to abandon the other amendments notwithstanding prior stockholder approval of such amendments, (2) directing that such proposed amendments to Homology’s Restated Certificate of Incorporation be submitted to the Homology stockholders for their approval and adoption, and (3) recommending that the Homology stockholders approve and adopt the proposed amendment. The text of the form of Certificate of Amendment would be filed with the Delaware Secretary of State to effect the Reverse Stock Split, are set forth in Annex G to this proxy statement/prospectus.

Reverse Stock Split Amendment

By approving this proposal, stockholders will approve alternative amendments to the Homology Restated Certificate of Incorporation pursuant to which a number of outstanding shares of Homology common stock between                  and                 , inclusive, would be combined into one share of Homology common stock. The number of shares of common stock underlying outstanding equity awards and available for future awards under Homology’s equity incentive plans, would also be proportionately reduced in the same manner as a result of the Reverse Stock Split. Upon receiving stockholder approval, the Homology board of directors will have the authority, but not the obligation, in its sole discretion, to elect, without further action on the part of the stockholders, whether to effect the Reverse Stock Split and, if so, to determine the Reverse Stock Split ratio from among the approved range described above and to effect the Reverse Stock Split by filing a Certificate of Amendment with the Secretary of State of the State of Delaware to be effective prior to the Effective Time, and all other amendments will be abandoned.

The Homology board of directors’ decision as to whether and when to effect the Reverse Stock Split will be based on a number of factors, including, without limitation, general market and economic conditions, the historical and then-prevailing trading price and trading volume of Homology common stock, the anticipated impact of the Reverse Stock Split on the trading price and trading volume of Homology common stock, the anticipated impact on Homology’s market capitalization, and the continued listing requirements of Nasdaq. Although the Homology stockholders may approve the Reverse Stock Split, Homology will not effect the Reverse Stock Split if the Homology board of directors does not deem it to be in the best interests of Homology and its stockholders.

Because the Reverse Stock Split will decrease the number of outstanding shares of Homology common stock by a ratio in the range of 1-for-                 to 1-for-                 but would not effect a decrease to the number of shares of common stock that Homology will be authorized to issue, the proposed Reverse Stock Split Amendments would result in a relative increase in the number of authorized and unissued shares of Homology common stock. For more information on the relative increase in the number of authorized shares of Homology common stock, see “—Principal Effects of the Reverse Stock Split—Issued and Outstanding Shares of Common Stock” below.

Purpose of the Reverse Stock Split

The Homology board of directors submits the Reverse Stock Split Proposal to its stockholders for approval and adoption with the primary intent of increasing the per share price of Homology common stock for the following principal reasons:

 

  •  

to encourage increased investor interest in Homology common stock and promote greater liquidity for its stockholders;

 

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  •  

to help attract, retain, and motivate employees; and

 

  •  

to ensure the continued listing of Homology common stock to facilitate the closing of the Merger.

Investor Interest and Liquidity

In addition, in approving the proposed Reverse Stock Split Amendments, the Homology board of directors considered that the Reverse Stock Split and the resulting increase in the per share price of Homology common stock could encourage increased investor interest in Homology common stock and promote greater liquidity for its stockholders.

In the event that Homology common stock were to be delisted from Nasdaq, Homology common stock would likely trade in the over-the-counter market. If Homology common stock were to trade on the over-the-counter market, selling Homology common stock could be more difficult because smaller quantities of shares would likely be bought and sold, and transactions could be delayed. In addition, many brokerage houses and institutional investors have internal policies and practices that prohibit them from investing in low-priced stocks or tend to discourage individual brokers from recommending low-priced stocks to their customers, further limiting the liquidity of Homology common stock. These factors could result in lower prices and larger spreads in the bid and ask prices for Homology common stock. Additionally, investors may be dissuaded from purchasing lower priced stocks because the brokerage commissions, as a percentage of the total transaction, tend to be higher for such stocks. Moreover, the analysts at many brokerage firms do not monitor the trading activity or otherwise provide coverage of lower priced stocks. A greater price per share of Homology common stock could allow a broader range of institutions to invest in Homology common stock. For all of these reasons, Homology believes the Reverse Stock Split could potentially increase marketability, trading volume, and liquidity of Homology common stock.

Employee Retention

The Homology board of directors believe that Homology’s employees and directors who are compensated in the form of Homology’s equity-based securities may be less incentivized and invested in Homology if Homology is no longer listed on Nasdaq. Accordingly, the Homology board of directors believe that maintaining Nasdaq listing qualifications for Homology common stock, can help attract, retain, and motivate employees and members of the Homology board of directors.

In light of the factors mentioned above, the Homology board of directors unanimously approved the proposed Reverse Stock Split Amendments to effect the Reverse Stock Split as Homology’s best means of increasing and maintaining the price of Homology common stock to above $1.00 per share in compliance with Nasdaq requirements.

Homology Board of Directors Discretion to Implement the Reverse Stock Split

The Homology board of directors believe that stockholder approval of a range of ratios (as opposed to a single Reverse Stock Split ratio) is in the best interests of Homology and stockholders because it is not possible to predict market conditions at the time the Reverse Stock Split would be effected. Homology believes that a range of Reverse Stock Split ratios provides Homology with the most flexibility to achieve the desired results of the Reverse Stock Split. The Reverse Stock Split ratio to be selected by the Homology board of directors will be a whole number in a range of 1-for-                 to 1-for-                . The Homology board of directors can only authorize the filing of one Reverse Stock Split Amendment and all other Reverse Stock Split Amendments will be abandoned. The Homology board of directors also has the authority to abandon all Reverse Stock Split Amendments.

In determining the Reverse Stock Split ratio and whether and when to effect the Reverse Stock Split following the receipt of stockholder approval, the Homology board of directors will consider a number of factors, including, without limitation:

 

  •  

Homology’s ability to maintain the listing of its common stock on Nasdaq;

 

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  •  

the historical trading price and trading volume of Homology common stock;

 

  •  

the number of shares of Homology common stock outstanding immediately before and after the Reverse Stock Split;

 

  •  

the then-prevailing trading price and trading volume of Homology common stock and the anticipated impact of the Reverse Stock Split on the trading price and trading volume of its common stock;

 

  •  

the anticipated impact of a particular ratio on Homology’s market capitalization; and

 

  •  

prevailing general market and economic conditions.

Homology believes that granting the Homology board of directors the authority to set the ratio for the Reverse Stock Split is essential because it allows Homology to take these factors into consideration and to react to changing market conditions. If the Homology board of directors choose to implement the Reverse Stock Split, Homology will make a public announcement regarding the determination of the Reverse Stock Split ratio.

Risks Associated with the Reverse Stock Split

There are risks associated with the Reverse Stock Split, including that the Reverse Stock Split may not result in a sustained increase in the per share price of Homology common stock. For risks associated with the Reverse Stock Split see “Risk Factors—Risks Related to the Proposed Reverse Stock Split” in this proxy statement/prospectus. Stockholders should note that the effect of the Reverse Stock Split, if any, upon the trading price of Homology common stock cannot be accurately predicted. In particular, Homology cannot assure you that the price for a share of Homology common stock after the Reverse Stock Split will increase in proportion to the reduction in the number of shares of Homology common stock outstanding before the Reverse Stock Split or, even if it does, that such price will be maintained for any period of time.

Even if an increased per share price can be maintained, the Reverse Stock Split may not achieve the desired results that have been outlined above under “Purpose of the Reverse Stock Split.” Moreover, because some investors may view the Reverse Stock Split negatively, Homology cannot assure you that the Reverse Stock Split will not adversely impact the market price of the common stock.

While Homology’s aim is that the Reverse Stock Split will be sufficient to maintain Homology’s listing on Nasdaq, it is possible that, even if the Reverse Stock Split results in a bid price for Homology common stock that exceeds $1.00 per share of common stock, Homology may not be able to continue to satisfy Nasdaq’s additional requirements and standards for continued listing of Homology common stock on Nasdaq.

Homology believes that the Reverse Stock Split may result in greater liquidity for its stockholders. However, it is also possible that such liquidity could be adversely affected by the reduced number of shares outstanding after the Reverse Stock Split, particularly if the price of Homology common stock does not increase as a result of the Reverse Stock Split.

Additionally, if the Reverse Stock Split is implemented, it may increase the number of stockholders who own “odd lots” of less than 100 shares of common stock. A purchase or sale of less than 100 shares (an “odd lot” transaction) may result in incrementally higher trading costs through certain brokers, particularly “full service” brokers. Therefore, those stockholders who own fewer than 100 shares of Homology common stock following the Reverse Stock Split may be required to pay higher transaction costs if they sell their shares of Homology common stock.

Principal Effects of the Reverse Stock Split

Issued and Outstanding Shares of Common stock

If the Reverse Stock Split is approved and effected, each holder of Homology common stock outstanding immediately prior to the effectiveness of the Reverse Stock Split will own a reduced number of shares of

 

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Homology common stock upon effectiveness of the Reverse Stock Split. The Reverse Stock Split would be effected simultaneously at the same exchange ratio for all outstanding shares of common stock, as required by Homology’s Restated Certificate of Incorporation. Except for adjustments that may result from the treatment of fractional shares (as described below), the Reverse Stock Split would affect all stockholders uniformly and would not change any stockholder’s relative percentage ownership interest in Homology, voting rights, or other rights that accompany shares of Homology common stock. Shares of Homology common stock issued pursuant to the Reverse Stock Split will remain fully paid and non-assessable, and the par value per share of common stock will remain $0.0001.

Relative Increase in Number of Authorized Shares of Common stock for Issuance

In the event that Homology’s board of directors determines to effect the Authorized Share Increase that is the subject of the Authorized Share Increase Proposal described under the heading “PROPOSAL NO. 2: APPROVAL OF THE AMENDMENT TO THE RESTATED CERTIFICATE OF INCORPORATION OF HOMOLOGY EFFECTING THE AUTHORIZED SHARE INCREASE,” the Restated Certificate of Incorporation will be amended to increase the number of authorized shares of Homology Common Stock from 200,000,000 shares to 400,000,000 shares. The Reverse Stock Split will not change the number of authorized shares of common stock. Although the number of authorized shares will not change as a result of the Reverse Stock Split, the number of issued and outstanding shares of Homology Common Stock will be reduced in proportion to the ratio selected by the Homology board of directors. Thus, the Reverse Stock Split will effectively increase the number of shares of Homology Common Stock the board of directors is authorized to issue under the Restated Certificate of Incorporation.

If the proposed Reverse Stock Split Amendment is approved, all or any of the authorized and unissued shares of Homology common stock may be issued in the future for such corporate purposes and such consideration as the Homology board of directors deem advisable from time to time, without further action by the stockholders of Homology and without first offering such shares to its stockholders. When and if additional shares of Homology common stock are issued, these new shares would have the same voting and other rights and privileges as the currently issued and outstanding shares of common stock, including the right to cast one vote per share.

Except pursuant to Homology’s equity incentive plans, Homology presently has no plan, commitment, arrangement, understanding, or agreement regarding the issuance of common stock other than the Merger Agreement and the Merger. However, Homology regularly considers its capital requirements and may conduct securities offerings, including equity and/or equity linked offerings, in the future. Any shares issuable pursuant to the above-described plans will be subject to the Reverse Stock Split ratio determined by the Homology board of directors.

Because Homology’s stockholders have no preemptive rights to purchase or subscribe for any of the unissued shares of common stock, the future issuance of additional shares of common stock will reduce Homology’s current stockholders’ percentage ownership interest in the total outstanding shares of common stock. In the absence of a proportionate increase in Homology’s future earnings and book value, an increase in the number of Homology’s outstanding shares of common stock would dilute Homology’s projected future earnings per share, if any, and book value per share of all Homology’s outstanding shares of common stock. If these factors were reflected in the price per share of Homology common stock, the potential realizable value of a stockholder’s investment could be adversely affected. An issuance of additional shares could therefore have an adverse effect on the potential realizable value of a stockholder’s investment.

Equity Compensation Plans and Outstanding Equity-Based Awards

Homology maintains the Homology Medicines, Inc. 2015 Stock Incentive Plan, or the Homology 2015 Plan, the Homology Medicines, Inc. 2018 Incentive Award Plan, or the Homology 2018 Plan, and the Homology

 

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Medicines, Inc. 2018 Employee Stock Purchase Plan, or the Homology ESPP, and collectively and together with any sub-plans thereunder, the Homology Plans, which are designed primarily to provide stock-based incentives to individual service providers of Homology.

The Homology board of directors generally has the discretion to determine the appropriate adjustments to the Homology Plans and outstanding awards and purchase rights under the Homology Plans in the event of a Reverse Stock Split. Accordingly, if the Reverse Stock Split is approved and effected, consistent with the terms of the Homology Plans and outstanding award agreements, the total number of shares of common stock issuable upon exercise, vesting or settlement of such awards or purchase rights and the total number of shares of common stock remaining available for future awards or purchase under the Homology Plans, as well as any share-based limits in the Homology Plans, would be proportionately reduced based on the Reverse Stock Split ratio selected by the Homology board of directors, and any fractional shares that may result therefrom shall be rounded down to the nearest whole share. Furthermore, the exercise or purchase price of any outstanding Homology options or purchase rights would be proportionately increased based on the Reverse Stock Split ratio selected by the Homology board of directors, and any fractional cents that may result therefrom shall be rounded up to the nearest whole cent. In addition, the numbers of shares subject to awards to be automatically granted in the future under the Homology Plans pursuant to the non-employee director compensation program will be proportionately reduced based on the Reverse Stock Split ratio selected by the Homology board of directors.

Illustration

For purposes of illustration, the following table contains approximate information relating to Homology common stock if the Reverse Stock Split is effected at a ratio of: 1-for-     , 1-for-                 , 1-for-                 , or 1-                 , based on share information as of the close of business on             , 2023, but does not give effect to any other changes, including any issuance of securities after             , 2023:

 

    Pre-Reverse
Split
    1-
for-
    1-
for-
    1-
for-
    1-
for-
 

Authorized

    200,000,000          

Issued and Outstanding

         

Reserved for future issuance pursuant to equity incentive and employee benefit plans(1)

         

Number of shares issuable upon exercise of outstanding Homology Options

         

Number of shares issuable upon vesting of outstanding Homology Restricted Stock Units

         

Authorized but unissued and unreserved(2)

         

 

(1)

Excludes shares issuable under outstanding equity-based awards (other than outstanding purchase rights under the Homology ESPP).

(2)

Shares authorized but unissued and unreserved represent common stock available for future issuance beyond shares issuable under outstanding equity-based awards and shares reserved for future issuance pursuant to equity incentive and employee benefit plans, and includes shares of common stock, if any, that may be issued under the ATM Program. See also note (1) above.

Procedure for Effecting the Reverse Stock Split and Exchange of Stock Certificates, if Applicable

If the proposed Reverse Stock Split Amendments are approved by Homology’s stockholders and Homology’s board of directors determines to effect the Reverse Stock Split, the Reverse Stock Split will become effective upon the filing of the Certificate of Amendment with the Secretary of State of the State of Delaware. At the Effective Time, shares of Homology common stock issued and outstanding immediately prior thereto will be combined, automatically and without any action on the part of the stockholders, into new shares of common stock, in accordance with the Reverse Stock Split ratio contained in the Certificate of Amendment.

 

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Registered “Book-Entry” Stockholders of Homology Common Stock

As soon as practicable after the Effective Time, stockholders will be notified by the transfer agent that the Reverse Stock Split has been effected. As all of the outstanding shares of Homology common stock are held in book-entry form, you will not need to take any action to receive post-Reverse Stock Split shares of Homology common stock upon the filing of the Certificate of Amendment. As soon as practicable after the Effective Time, the transfer agent will send to your registered address a transmittal letter along with a statement of ownership indicating the number of post-Reverse Stock Split shares of common stock you hold. If applicable, a check representing a cash payment in lieu of fractional shares will also be mailed to your registered address as soon as practicable after the Effective Time (see “—Fractional Shares” below).

Beneficial Stockholders of Homology Common Stock

Upon the implementation of the Reverse Stock Split, Homology intends to treat shares of common stock held by stockholders in “street name” (i.e., through a bank, broker, custodian, or other nominee), in the same manner as registered “book-entry” stockholders of common stock. Banks, brokers, custodians or other nominees will be instructed to effect the Reverse Stock Split for their beneficial stockholders holding Homology common stock in street name. However, these banks, brokers, custodians or other nominees may have different procedures than registered stockholders for processing the Reverse Stock Split and making payment for fractional shares. If a stockholder holds shares of Homology common stock with a bank, broker, custodian, or other nominee and has any questions in this regard, stockholders are encouraged to contact their bank, broker, custodian, or other nominee.

Stockholders of Certificated Shares of Homology Common Stock

The transfer agent will act as exchange agent for purposes of implementing the exchange of stock certificates, if applicable. If you are a stockholder holding pre-Reverse Stock Split shares in certificate form, you will receive a transmittal letter from the transfer agent as soon as practicable after the Effective Time. The transmittal letter will be accompanied by instructions specifying how you can exchange your certificate or certificates representing the pre-Reverse Stock Split shares of Homology common stock for a statement of ownership. When you submit your certificate or certificates representing the pre-Reverse Stock Split shares of Homology common stock, your post-Reverse Stock Split shares of Homology common stock will be held electronically in book-entry form in the Direct Registration System. This means that, instead of receiving a new stock certificate representing the aggregate number of post-Reverse Stock Split shares you own, you will receive a statement indicating the number of post-Reverse Stock Split shares you own in book-entry form. Homology will no longer issue physical stock certificates unless you make a specific request for a certificate representing your post-Reverse Stock Split ownership interest.

Fractional Shares

No scrip or fractional shares would be issued if, as a result of the Reverse Stock Split, a stockholder would otherwise become entitled to a fractional share because the number of shares of common stock they hold before the Reverse Stock Split is not evenly divisible by the split ratio ultimately determined by the Homology board of directors. Instead, each stockholder will be entitled to receive a cash payment in lieu of such fractional share. The cash payment to be paid will be equal to the fraction of a share to which such stockholder would otherwise be entitled multiplied by the closing price per share of common stock on the date of the Effective Time as reported by Nasdaq (as adjusted to give effect to the Reverse Stock Split). No transaction costs would be assessed to stockholders for the cash payment. Stockholders would not be entitled to receive interest for their fractional shares for the period of time between the Effective Time and the date payment is issued or received.

After the Reverse Stock Split, then-current stockholders would have no further interest in Homology with respect to their fractional shares. A person entitled to a fractional share would not have any voting, dividend or other rights in respect of their fractional share except to receive the cash payment as described above. Such cash

 

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payments would reduce the number of post-Reverse Stock Split stockholders to the extent that there are stockholders holding fewer than that number of pre-Reverse Stock Split shares within the Reverse Stock Split ratio that is determined by the Homology board of directors as described above. Reducing the number of post-Reverse Stock Split stockholders, however, is not the purpose of this proposal.

Stockholders should be aware that, under the escheat laws of the various jurisdictions where stockholders reside, where Homology is domiciled and where the funds for fractional shares would be deposited, sums due to stockholders in payment for fractional shares that are not timely claimed after the Effective Time may be required to be paid to the designated agent for each such jurisdiction. Thereafter, stockholders otherwise entitled to receive such funds may have to seek to obtain them directly from the state to which they were paid.

No Appraisal Rights

Under the DGCL, Homology’s stockholders will not be entitled to appraisal rights with respect to the Reverse Stock Split, and Homology does not intend to independently provide stockholders with any such right.

No Going Private Transaction

Notwithstanding the decrease in the number of outstanding shares following the Reverse Stock Split, the Homology board of directors does not intend for this transaction to be the first step in a series of plans or proposals of a “going private transaction” within the meaning of Rule 13e-3 of the Exchange Act.

Interests of Certain Persons in the Proposal

Certain of Homology’s officers and directors have an interest in this proposal as a result of their ownership of shares of Homology common stock, as set forth below in the section entitled “Principal Stockholders of Homology”. However, Homology does not believe that its officers or directors have interests in this proposal that are different from or greater than those of any of the other stockholders.

Anti-Takeover Effects of Proposed Amendment

Release No. 34-15230 of the staff of the SEC requires disclosure and discussion of the effects of any action, including the proposed Reverse Stock Split Amendments discussed herein, that may be used as an anti-takeover mechanism. An additional effect of the Reverse Stock Split would be to increase the relative amount of authorized but unissued shares of common stock, which may, under certain circumstances, be construed as having an anti-takeover effect. Although not designed or intended for such purposes, the effect of the increased available shares might be to make more difficult or to discourage an attempt to take over or otherwise acquire control of Homology (for example, by permitting issuances that would dilute the stock ownership of a person or entity seeking to effect a change in the composition of the board of directors or contemplating a tender offer or other change in control transaction). In addition, Homology’s Restated Certificate of Incorporation and Amended and Restated Bylaws include provisions that may have an anti-takeover effect. These provisions, among things, permit the Homology board of directors to issue preferred stock with rights senior to those of the common stock without any further vote or action by the stockholders and do not provide for cumulative voting rights, which could make it more difficult for stockholders to effect certain corporate actions and may delay or discourage a change in control.

The Homology board of directors is not presently aware of any attempt, or contemplated attempt, to acquire control of Homology, and the Reverse Stock Split Proposal is not part of any plan by the Homology board of directors to recommend or implement a series of anti-takeover measures.

Accounting Treatment of the Reverse Stock Split

If the Reverse Stock Split is effected, the par value per share of Homology common stock will remain unchanged at $0.0001. Accordingly, at the Effective Time, the stated capital on Homology’s consolidated

 

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balance sheets attributable to Homology common stock will be reduced in proportion to the size of the Reverse Stock Split ratio, and the additional paid-in-capital account will be increased by the amount by which the stated capital is reduced. The stockholders’ equity, in the aggregate, will remain unchanged. Per share net income or loss will be increased because there will be fewer shares of common stock outstanding. Homology does not anticipate that any other accounting consequences, including changes to the amount of stock-based compensation expense to be recognized in any period, will arise as a result of the Reverse Stock Split.

Material U.S. Federal Income Tax Consequences of the Reverse Stock Split to U.S. Holders of Homology Common Stock

The following discussion is a summary of the material U.S. federal income tax consequences of the Reverse Stock Split to U.S. Holders of Homology common stock, but does not purport to be a complete analysis of all potential tax effects. The effects of other U.S. federal tax laws, such as estate and gift tax laws, and any applicable state, local, or non-U.S. tax laws are not discussed. Furthermore, the following discussion does not address any tax consequences of transactions effectuated before, after or at the same time as the Reverse Stock Split (except, to the limited extent discussed in the section entitled “Agreements Related to the Merger—Contingent Value Rights Agreement—Material U.S. Federal Income Tax Consequences of the CVRs to Holders of Homology Common Stock,” the distribution of the CVRs), whether or not they are in connection with the Reverse Stock Split.

This discussion is based on the Code, Treasury Regulations promulgated thereunder, judicial decisions, and published rulings and administrative pronouncements of the IRS, in each case, as in effect as of the date hereof. These authorities may change or be subject to differing interpretations. Any such change or differing interpretation may be applied retroactively in a manner that could adversely affect a U.S. Holder. Homology has not sought and will not seek an opinion of counsel or any rulings from the IRS regarding the matters discussed below. There can be no assurance the IRS or a court will not take a contrary position to that discussed below regarding the tax consequences of the Reverse Stock Split.

This discussion is limited to U.S. Holders who hold their Homology common stock as a “capital asset” within the meaning of Section 1221 of the Code (generally, property held for investment). This discussion does not address all U.S. federal income tax consequences relevant to the particular circumstances of a U.S. Holder, including the impact of the Medicare contribution tax on net investment income and the alternative minimum tax. In addition, it does not address consequences relevant to U.S. Holders that are subject to particular rules, including, without limitation:

 

  •  

U.S. expatriates or former citizens or long-term residents of the United States;

 

  •  

persons whose functional currency is not the U.S. dollar;

 

  •  

persons holding Homology common stock as part of a hedge, straddle, or other risk reduction strategy or as part of a conversion transaction or other integrated investment;

 

  •  

banks, insurance companies, and other financial institutions;

 

  •  

real estate investment trusts or regulated investment companies;

 

  •  

brokers, dealers, or traders in securities;

 

  •  

S corporations, partnerships, or other entities or arrangements treated as pass-through entities for U.S. federal income tax purposes (and investors therein);

 

  •  

tax-exempt organizations, qualified retirement plans, individual retirement accounts or other tax deferred accounts, or governmental organizations;

 

  •  

persons deemed to sell Homology common stock under the constructive sale provisions of the Code;

 

  •  

persons who hold or receive Homology common stock pursuant to the exercise of any employee stock options or otherwise as compensation;

 

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  •  

persons who are not U.S. Holders;

 

  •  

corporations that accumulate earnings to avoid U.S. federal income tax; and

 

  •  

persons subject to special tax accounting rules as a result of any item of gross income with respect to the Homology common stock being taken into account in an applicable financial statement.

If a partnership, or an entity treated as a partnership for U.S. federal income tax purposes, holds Homology common stock, the tax treatment of a partner in the partnership will depend on the status of the partner, the activities of the partnership, and certain determinations made at the partner level. Accordingly, partnerships holding Homology common stock and the partners in such partnerships should consult their tax advisors regarding the U.S. federal income tax consequences to them.

THIS DISCUSSION IS NOT TAX ADVICE. HOLDERS OF HOMOLOGY COMMON STOCK SHOULD CONSULT THEIR TAX ADVISORS WITH RESPECT TO THE APPLICATION OF THE U.S. FEDERAL INCOME TAX LAWS TO THEIR PARTICULAR SITUATIONS AS WELL AS ANY TAX CONSEQUENCES OF THE REVERSE STOCK SPLIT ARISING UNDER OTHER U.S. FEDERAL TAX LAWS (INCLUDING ESTATE AND GIFT TAX LAWS), UNDER THE LAWS OF ANY STATE, LOCAL, OR NON-U.S. TAXING JURISDICTION OR UNDER ANY APPLICABLE TAX TREATY.

Material U.S. Federal Income Tax Consequences for U.S. Holders

For purposes of this discussion, a “U.S. Holder” is any beneficial owner of Homology common stock that, for U.S. federal income tax purposes, is or is treated as:

 

  •  

an individual who is a citizen or resident of the United States;

 

  •  

a corporation created or organized in or under the laws of the United States, any state thereof, or the District of Columbia;

 

  •  

an estate, the income of which is subject to U.S. federal income tax regardless of its source; or

 

  •  

a trust that (1) is subject to the primary supervision of a U.S. court and all substantial decisions of which are subject to the control of one or more “United States persons” (within the meaning of Section 7701(a)(30) of the Code), or (2) has a valid election in effect to be treated as a United States person for U.S. federal income tax purposes.

The Reverse Stock Split should constitute a “recapitalization” for U.S. federal income tax purposes. As a result, a U.S. Holder generally should not recognize gain or loss upon the Reverse Stock Split, except as described below with respect to cash received in lieu of fractional shares. A U.S. Holder’s aggregate tax basis in the shares of the Homology common stock received pursuant to the Reverse Stock Split should equal such holder’s aggregate tax basis in the shares of the Homology common stock surrendered (excluding any portion of such basis that is allocated to any fractional share of Homology common stock), and such holder’s holding period in the shares of the Homology common stock received should include the holding period of the shares of the Homology common stock surrendered. Treasury Regulations promulgated under the Code provide detailed rules for allocating the tax basis and holding period of the shares of Homology common stock surrendered pursuant to the Reverse Stock Split to the shares of Homology common stock received pursuant to the Reverse Stock Split. U.S. Holders holding shares of Homology common stock that were acquired on different dates and at different prices should consult their tax advisors regarding the allocation of the tax basis and holding period of such shares.

A U.S. Holder who receives cash in lieu of a fractional share of Homology common stock should be treated as first receiving such fractional share and then receiving cash in redemption of such fractional share. A U.S. Holder who receives cash in lieu of a fractional share in the Reverse Stock Split should recognize capital gain or

 

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loss in an amount equal to the difference between the amount of the cash received in lieu of a fractional share and the portion of such stockholder’s adjusted tax basis allocable to the fractional share. Such capital gain or loss should be long-term capital gain or loss if the U.S. Holder’s holding period for the Homology common stock surrendered exceeded one year at the Effective Time of the Reverse Stock Split. The deductibility of capital losses is subject to limitations. U.S. Holders should consult their tax advisors regarding the tax effects to them of receiving cash in lieu of fractional shares based on their particular circumstances.

U.S. Holders (other than corporations and certain other exempt recipients) may be subject to information reporting with respect to any cash received in exchange for a fractional share interest in a new share in the Reverse Stock Split. U.S. Holders who are subject to information reporting and who do not provide a correct taxpayer identification number and other required information (such as by submitting a properly completed IRS Form W-9) may also be subject to backup withholding at the applicable rate. Backup withholding is not an additional tax. Any amounts withheld under the backup withholding rules may be refunded or credited against the U.S. Holder’s U.S. federal income tax liability, if any, provided that the required information is properly furnished in a timely manner to the IRS. U.S. Holders should consult their tax advisors regarding their qualification for an exemption from backup withholding and the procedures for obtaining such an exemption.

Required Vote

The affirmative vote of a majority in voting power of the votes cast affirmatively or negatively in attendance or represented by proxy at the Homology Special Meeting and entitled to vote on the matter is required to approve the amendment to the Restated Certificate of Incorporation of Homology effecting the Reverse Stock Split, subject to the Homology board of directors’ authority to abandon such amendment.

HOMOLOGY’S BOARD OF DIRECTORS RECOMMENDS A VOTE “FOR” THIS PROPOSAL NO. 3 TO APPROVE THE AMENDMENT TO THE RESTATED CERTIFICATE OF INCORPORATION EFFECTING THE REVERSE STOCK SPLIT.

Unless otherwise instructed, it is the intention of the persons named in the accompanying proxy card to vote shares represented by properly executed proxy cards “FOR” the approval of the amendment to the Restated Certificate of Incorporation of Homology to effect the Reverse Stock Split.

 

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PROPOSAL NO. 4: APPROVAL OF THE 2024 STOCK OPTION AND INCENTIVE PLAN

Overview

As discussed in this proxy statement/prospectus, Homology is asking its stockholders to consider and vote upon a proposal to approve and adopt the Q32 Inc. 2024 Stock Option and Incentive Plan, or the 2024 Plan, a copy of which is attached to this proxy statement/prospectus as Annex I, or the Stock Option and Incentive Plan Proposal.

The 2024 Plan is intended to replace the Q32 2017 Stock Option Plan and Grant Plan, or the Q32 2017 Plan, as well as the Homology 2015 Stock Incentive Plan, or the Homology 2015 Plan, and the Homology 2018 Plan, or, together with the Homology 2015 Plan, the Homology Incentive Plans. If the 2024 Plan becomes effective, then no additional awards will be granted under the Q32 2017 Plan as in effect immediately prior to the closing date of the Merger or the Homology Incentive Plans, although all outstanding stock awards granted under the Q32 2017 Plan as in effect immediately prior to the closing of the Merger will be assumed and converted into stock awards of the combined company and will remain subject to the terms and conditions of the agreements evidencing such awards and the terms of the Q32 2017 Plan. Each Homology restricted stock unit award that is outstanding immediately prior to the Effective Time will be accelerated in full immediately prior to the Effective Time. In addition, all outstanding and unvested options to purchase Homology common stock shall vest in full in accordance with the terms of the Merger Agreement and remain outstanding following the Effective Time, provided that any such Homology options that have an exercise price equal to or greater than the closing trading price of a share of Homology Common Stock on the last full trading day on which the Homology Common Stock is traded prior to the Effective Time shall be cancelled for no consideration.

Reasons to Approve the 2024 Plan

The purpose of the 2024 Plan is to enhance the ability of the combined company to attract, retain and incentivize employees, independent contractors and directors and promote the success of its business. Equity compensation can play an important role in the success of the combined company by encouraging and enabling employees, independent contractors and directors, upon whose judgment, initiative and efforts the combined company largely depends for the successful conduct of its business, to acquire a proprietary interest in the combined company. Accordingly, the ability to grant stock awards at competitive levels will be a vital element of the combined company’s compensation program and is, therefore, in the best interest of the combined company and its stockholders. If Homology’s stockholders do not approve the 2024 Plan, the Homology Incentive Plans will remain in effect in accordance with their terms. In such event, the combined company’s board of directors may consider whether to adopt alternative arrangements based on its assessment of the combined company’s needs. Without stockholder approval of the 2024 Plan, the combined company could be limited in its ability to offer a competitive equity compensation program to attract, retain and motivate the talented and qualified employees necessary for the continued growth and success of the combined company, especially in an industry that increasingly relies on equity compensation as a key component of overall employee compensation.

Approval of the 2024 Plan by Homology’s stockholders is required, among other things, in order to comply with stock exchange rules requiring stockholder approval of equity compensation plans and allow the grant of incentive stock options under the 2024 Plan. If the 2024 Plan is approved by Homology’s stockholders, the 2024 Plan will become effective as of the Effective Time and the combined company will register the necessary shares of its common stock on a Registration Statement on Form S-8.

A total of              shares (before giving effect to the proposed Reverse Stock Split) will be reserved for issuance under the 2024 Plan. As of                 , the closing price on Nasdaq per share of Homology common stock was $        . Based upon a price per share of $        , the maximum aggregate market value that could potentially be issued under the 2024 Plan at the Effective Time is $        . The Homology board of directors approved the 2024 Plan on             , 2024, subject to the approval by Homology’s stockholders and effective as of the Effective Time. If the closing of the Merger does not occur or the 2024 Plan is not approved by Homology’s

 

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stockholders, the 2024 Plan will not become effective and no stock awards will be granted thereunder, and the Homology Incentive Plans will remain in full force and effect and available for the grant of stock awards thereunder (subject to the terms of the plans).

The following is a summary of the material features of the 2024 Plan. This summary is qualified in its entirety by the full text of the 2024 Plan, a copy of which is included as Annex I to this proxy statement/prospectus.

Summary of the Material Provisions of the Q32 Inc. 2024 Stock Option and Incentive Plan

The 2024 Plan is intended to allow the combined company to make equity and equity-based incentive awards to officers, employees, directors and consultants. The combined company anticipates that providing such persons with a direct stake in the combined company will assure a closer alignment of the interests of such individuals with those of the combined company and its stockholders, thereby stimulating their efforts on the combined company’s behalf and strengthening their desire to remain with the combined company.

The maximum aggregate number of shares that may be issued under the 2024 Plan is                  shares (before giving effect to the proposed Reverse Stock Split), or the Initial Limit. The 2024 Plan provides that the number of shares reserved and available for issuance under the 2024 Plan will automatically increase each January 1, beginning on January 1, 2025, by 5% of the outstanding number of shares on the immediately preceding December 31, or such lesser amount as determined by the plan administrator, or the Annual Increase. This limit is subject to adjustment in the event of a reorganization, recapitalization, reclassification, stock split, stock dividend, reverse stock split or other similar change in the combined company’s capitalization. The maximum aggregate number of shares that may be issued upon exercise of incentive stock options under the 2024 Plan shall not exceed the Initial Limit cumulatively increased on January 1, 2025 and on each January 1 thereafter by the lesser of the Annual Increase or                  shares (before giving effect to the proposed Reverse Stock Split). Shares underlying any awards under the 2024 Plan and the shares underlying awards under the Q32 2017 Plan or Homology Incentive Plans that are forfeited, canceled, held back upon exercise of an option or settlement of an award to cover the exercise price or tax withholding, reacquired by the combined company prior to vesting, satisfied without the issuance of stock or otherwise terminated (other than by exercise) shall be added back to the shares available for issuance under the 2024 Plan and, to the extent permitted under Section 422 of the Code and the regulations promulgated thereunder, the shares that may be issued as incentive stock options. Awards that may be settled solely in cash will not be counted against the shares available for issuance under the 2024 Plan and will not reduce the shares authorized for grant to a grantee in any calendar year.

The 2024 Plan contains a limitation whereby the value of all awards under the 2024 Plan and all other cash compensation paid to any non-employee director for services as a non-employee director may not exceed $                 in any calendar year; provided, however, that such amount will be $                 for the first calendar year a non-employee director is initially appointed to the combined company’s board of directors.

The 2024 Plan will be administered by the combined company’s board of directors, the compensation committee of the combined company’s board of directors or such other similar committee pursuant to the terms of the 2024 Plan. The plan administrator, which initially will be the compensation committee of the combined company’s board of directors, will have full power to select, from among the individuals eligible for awards, the individuals to whom awards will be granted, to make any combination of awards to participants, and to determine the specific terms and conditions of each award, subject to the provisions of the 2024 Plan. The plan administrator may delegate to a committee consisting of one or more officers the authority to grant stock options and other awards to employees who are not subject to the reporting and other provisions of Section 16 of the Exchange Act and not members of the delegated committee, subject to certain limitations and guidelines. Persons eligible to participate in the 2024 Plan will be officers, employees, non-employee directors and consultants of the combined company as selected from time to time by the plan administrator in its discretion.

 

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Immediately following completion of the Merger, the combined company is expected to have a total of approximately                      employees,                  consultants and                  non-employee directors who will be eligible to be granted stock awards from the 2024 Plan.

The 2024 Plan permits the granting of both options to purchase shares intended to qualify as incentive stock options under Section 422 of the Code and options that do not so qualify. Options granted under the 2024 Plan will be non-qualified options if they fail to qualify as incentive stock options or exceed the annual limit on incentive stock options. Incentive stock options may only be granted to employees of the combined company and its subsidiaries. Non-qualified options may be granted to any persons eligible to receive awards under the 2024 Plan. The option exercise price of each option will be determined by the plan administrator but generally may not be less than 100% of the fair market value of the combined company’s share on the date of grant or, in the case of an incentive stock option granted to a 10% stockholder, 110% of such share’s fair market value. The term of each option will be fixed by the plan administrator and may not exceed ten years from the date of grant or, in the case of an incentive stock option granted to a ten percent stockholder, five years from the date of grant. The plan administrator will determine at what time or times each option will vest and may be exercised, including the ability to accelerate the vesting of such options.

Upon exercise of options, the option exercise price must be paid in full either in cash, by certified or bank check or other instrument acceptable to the plan administrator or by delivery (or attestation to the ownership) of shares that are beneficially owned by the optionee free of restrictions or were purchased in the open market. Subject to applicable law, the exercise price may also be delivered by a broker pursuant to irrevocable instructions to the broker from the optionee. In addition, the plan administrator may permit non-qualified options to be exercised using a “net exercise” arrangement that reduces the number of shares issued to the optionee by the largest whole number of shares with fair market value that does not exceed the aggregate exercise price.

The plan administrator may award stock appreciation rights subject to such conditions and restrictions as it may determine. Stock appreciation rights entitle the recipient to shares or cash, equal to the value of the appreciation in the combined company’s stock price over the exercise price. The exercise price generally may not be less than 100% of the fair market value of the combined company’s share on the date of grant. The term of each stock appreciation right will be fixed by the plan administrator and may not exceed ten years from the date of grant. The plan administrator will determine at what time or times each stock appreciation right will vest and may be exercised, including the ability to accelerate the vesting of such stock appreciation right.

The plan administrator may award restricted shares and restricted stock units to participants subject to such conditions and restrictions as it may determine. These conditions and restrictions may include the achievement of certain performance goals and/or continued employment with the combined company through a specified vesting period. The plan administrator may also grant shares that are free from any restrictions under the 2024 Plan. Unrestricted stock may be granted to participants in recognition of past services or for other valid consideration and may be issued in lieu of cash compensation due to such participant. The plan administrator may grant dividend equivalent rights to participants that entitle the recipient to receive credits for dividends that would be paid if the recipient had held a specified number of shares.

The plan administrator may grant cash-based awards under the 2024 Plan to participants.

The 2024 Plan requires the plan administrator to make appropriate adjustments to the number of shares of common stock that are subject to the 2024 Plan, to certain limits in the 2024 Plan, and to any outstanding awards to reflect stock dividends, stock splits, extraordinary cash dividends and similar events.

The 2024 Plan provides that upon the effectiveness of a “sale event,” as defined in the 2024 Plan, an acquirer or successor entity may assume, continue or substitute for the outstanding awards under the 2024 Plan. To the extent that awards granted under the 2024 Plan are not assumed, continued or substituted by the successor entity, all awards granted under the 2024 Plan shall terminate. In addition, except as may be otherwise provided

 

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in the relevant award agreement, all stock options and stock appreciation rights with time-based vesting conditions or restrictions that are not vested and/or exercisable immediately prior to the effective time of the sale event shall become fully vested and exercisable as of the effective time of the sale event, all other awards with time-based vesting conditions or restrictions shall become fully vested and nonforfeitable as of the effective time of the sale event, and all awards with conditions and restrictions relating to the attainment of performance goals shall become vested and nonforfeitable in connection with a sale event at the greater of (A) target levels or (B) actual performance. In the event of such termination, individuals holding options and stock appreciation rights will, for each such award, either (a) receive a payment in cash or in kind for each share subject to such award that is exercisable in an amount equal to the per share cash consideration payable to stockholders in the sale event less the applicable per share exercise price (provided that, in the case of an option or stock appreciation right with an exercise price equal to or greater than the per share cash consideration payable to stockholders in the sale event, such option or stock appreciation right shall be cancelled for no consideration) or (b) be permitted to exercise such options and stock appreciation rights (to the extent exercisable) within a specified period of time prior to the sale event. The plan administrator shall also have the option (in its sole discretion) to make or provide for a payment, in cash or in kind, to the grantees holding other awards in an amount equal to the per share cash consideration payable to stockholders in the sale event multiplied by the number of vested shares under such awards.

Participants in the 2024 Plan are responsible for the payment of any federal, state or local taxes that the combined company is required by law to withhold upon the exercise of options or stock appreciation rights or vesting of other awards. The plan administrator may cause any tax withholding obligation of the combined company to be satisfied, in whole or in part, by the combined company withholding from shares to be issued pursuant to an award a number of shares with an aggregate fair market value that would satisfy the withholding amount due. The plan administrator may also require any tax withholding obligation of the combined company to be satisfied, in whole or in part, by an arrangement whereby a certain number of shares issued pursuant to any award are immediately sold and proceeds from such sale are remitted to the combined company in an amount that would satisfy the withholding amount due.

The 2024 Plan generally does not allow for the transfer or assignment of awards, other than by will or by the laws of descent and distribution or pursuant to a domestic relations order; however, the plan administrator may permit the transfer of non-qualified stock options by gift to an immediate family member, to trusts for the benefit of family members, or to partnerships in which such family members are the only partners. All awards will be subject to any combined company clawback policy as set forth in such clawback policy or the applicable award agreement.

The plan administrator may amend or discontinue the 2024 Plan and the plan administrator may amend or cancel outstanding awards for purposes of satisfying changes in law or any other lawful purpose, but no such action may materially and adversely affect rights under an award without the holder’s consent. The plan administrator is specifically authorized to reduce the exercise price of outstanding options or stock appreciation rights, effect the repricing of such awards through cancellation and re-grants or cancel such awards in exchange for cash or other awards without prior stockholder approval. Certain amendments to the 2024 Plan require the approval of the combined company’s stockholders.

No awards may be granted under the 2024 Plan after the date that is ten years from the Effective Time. No awards under the 2024 Plan have been made prior to the date hereof.

Form S-8

Following the consummation of the Merger, the combined company will file with the SEC a registration statement on Form S-8 covering the shares issuable under the 2024 Plan.

 

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Certain U.S. Federal Income Tax Consequences

The following is a summary of the principal U.S. federal income tax consequences of certain transactions under the 2024 Plan. It does not describe all federal tax consequences under the 2024 Plan, nor does it describe state or local tax consequences.

Incentive Stock Options. No taxable income is generally recognized by the optionee upon the grant or exercise of an incentive stock option. If shares issued to an optionee pursuant to the exercise of an incentive stock option are sold or transferred after two years from the date of grant and after one year from the date of exercise, then generally (i) upon sale of such shares, any amount realized in excess of the option exercise price (the amount paid for the shares) will be taxed to the optionee as a long-term capital gain, and any loss sustained will be a long-term capital loss, and (ii) the combined company will not be entitled to any deduction for federal income tax purposes; provided that such incentive stock option otherwise meets all of the technical requirements of an incentive stock option. The exercise of an incentive stock option will give rise to an item of tax preference that may result in alternative minimum tax liability for the optionee.

If shares acquired upon the exercise of an incentive stock option are disposed of prior to the expiration of the two-year and one-year holding periods described above (a “disqualifying disposition”), generally (i) the optionee will recognize ordinary income in the year of disposition in an amount equal to the excess (if any) of the fair market value of the shares at exercise (or, if less, the amount realized on a sale of such shares) over the option price thereof, and (ii) the combined company will be entitled to deduct such amount. Special rules will apply where all or a portion of the exercise price of the incentive stock option is paid by tendering shares.

If an incentive stock option is exercised at a time when it no longer qualifies for the tax treatment described above, the option is treated as a non-qualified option. Generally, an incentive stock option will not be eligible for the tax treatment described above if it is exercised more than three months following termination of employment (or one year in the case of termination of employment by reason of disability). In the case of termination of employment by reason of death, the three-month rule does not apply.

No income is generally recognized by the optionee at the time a non-qualified option is granted. Generally (i) at exercise, ordinary income is recognized by the optionee in an amount equal to the difference between the option exercise price and the fair market value of the shares on the date of exercise, and the combined company will receive a tax deduction for the same amount, and (ii) at disposition, appreciation or depreciation after the date of exercise is treated as either short-term or long-term capital gain or loss depending on how long the shares have been held. Special rules will apply where all or a portion of the exercise price of the non-qualified option is paid by tendering shares. Upon exercise, the optionee will also be subject to social security taxes on the excess of the fair market value over the exercise price of the option.

All Other Awards. For all other awards under the 2024 Plan, the combined company generally will be entitled to a tax deduction in connection with other awards under the 2024 Plan in an amount equal to the ordinary income recognized by the participant at the time the participant recognizes such income. Participants typically are subject to income tax and recognize such tax at the time that an award is exercised, vests or becomes non-forfeitable, unless the award provides for deferred settlement.

Section 162(m) of the Code limits the deduction certain employers may take for otherwise deductible compensation payable to certain executive officers of the employer to the extent the compensation paid to such an officer for the year exceeds $1 million.

The vesting of any portion of an award that is accelerated due to the occurrence of a change in control (such as a sale event) may cause all or a portion of the payments with respect to such accelerated awards to be treated as “excess parachute payments” as defined in Section 280G of the Code. Any such excess parachute payments may be non-deductible to the combined company, in whole or in part, and may subject the recipient to a non-deductible 20% federal excise tax on all or a portion of such payment (in addition to other taxes ordinarily payable).

 

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Application of Section 409A of the Code

Section 409A of the Code imposes an additional 20% tax and interest on an individual receiving nonqualified deferred compensation under a plan that fails to satisfy certain requirements. For purposes of Section 409A, “nonqualified deferred compensation” includes equity-based incentive programs, including some stock options, stock appreciation rights and restricted stock units. Generally speaking, Section 409A does not apply to incentive stock options, and non-discounted non-qualified stock options and stock appreciation rights if no deferral is provided beyond exercise, or restricted stock.

The awards made pursuant to the 2024 Plan are expected to be designed in a manner intended to comply with the requirements of Section 409A of the Code such that no adverse tax consequences under Section 409A apply to the extent the awards granted under the 2024 Plan are not exempt from coverage. However, if the 2024 Plan fails to comply with Section 409A in operation, a participant could be subject to the additional taxes and interest.

State, local and foreign tax consequences may in some cases differ from the U.S. federal income tax consequences described above. The aforementioned summary of the U.S. federal income tax consequences in respect of the 2024 Plan is for general information only.

Interested parties should consult their own advisors as to specific tax consequences of their awards. The 2024 Plan is not subject to the Employee Retirement Income Security Act of 1974, as amended, and is not intended to be qualified under Section 401(a) of the Code.

New Plan Benefits

No awards have been previously granted under the 2024 Plan and no awards have been granted that are contingent on stockholder approval of the 2024 Plan. The awards that are to be granted to any participant or group of participants are indeterminable at the date of this proxy statement/prospectus because participation and the types of awards that may be granted under the 2024 Plan are subject to the discretion of the plan administrator. Consequently, no new plan benefits table is included in this proxy statement/prospectus.

Interests of Certain Persons in this Proposal

The existence of financial and personal interests of one or more of Homology’s directors may result in a conflict of interest on the part of such director(s) between what he or she may believe is in the best interests of Homology and its stockholders and what he or she may believe is best for himself or herself in determining to recommend that stockholders vote for the proposals. In addition, Homology’s officers have interests in the Merger that may conflict with the interests of Homology’s stockholders. See the section entitled “The Merger—Interests of Homology Directors and Executive Officers in the Merger” for a further discussion of these considerations.

 

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Equity Compensation Plan Information

The following table sets forth information as of December 31, 2022 regarding shares of common stock that may be used under Homology’s equity compensation plans.

 

Plan category

   Number of securities to
be issued upon exercise
of outstanding options,
warrants and rights
    Weighted-average
exercise price of
outstanding options,
warrants and rights
    Number of securities
remaining available for
future issuance under

equity compensation
plans (excluding
securities reflected in
column (a))(4)
 
     (a)     (b)     (c)  

Equity compensation plans approved by security holders(1)

     10,408,913 (2)    $ 10.96 (3)      3,964,791  

Equity compensation plans not approved by security holders

     —         —         —    
  

 

 

   

 

 

   

 

 

 

Total

     10,408,913     $ 10.96       3,964,791  

 

(1)

Consists of the 2015 Stock Incentive Plan, as amended, or the 2015 Plan, the 2018 Incentive Award Plan, or the 2018 Plan, and the 2018 Employee Stock Purchase Plan, or the 2018 ESPP.

(2)

Includes 1,569,782 outstanding options to purchase stock under the 2015 Plan, 8,295,952 outstanding options to purchase stock under the 2018 Plan and 543,179 outstanding restricted stock units under the 2018 Plan.

(3)

As of December 31, 2022, the weighted-average exercise price of outstanding options under the 2015 Plan was $3.96 and the weighted-average exercise price of outstanding options under the 2018 Plan was $12.28. This amount does not take into account restricted stock units, which have no exercise price.

(4)

Includes 2,188,360 shares available for future issuance under the 2018 Plan and 1,776,431 shares available for future issuance under the 2018 ESPP (of which 116,332 shares were issued with respect to the purchase period in effect as of December 31, 2022, which purchase period ended on February 28, 2023). As of March 26, 2018, in connection with Homology’s initial public offering, no further grants are made under the 2015 Plan. The 2018 Plan provides for an annual increase on the first day of each calendar year beginning on January 1, 2019 and ending on and including January 1, 2028, by an amount equal to the lesser of (i) 4% of the aggregate number of shares of common stock outstanding on the final day of the immediately preceding calendar year and (ii) such smaller number of shares of common stock as determined by Homology’s board of directors (but no more than 20,887,347 shares may be issued upon the exercise of incentive stock options), plus any shares that were subject to awards outstanding under the 2015 Plan as of the effective date of the 2018 Plan which are forfeited, expire, lapse for any reason or are settled for cash without the issuance of shares. The 2018 ESPP provides for an annual increase on the first day of each calendar year beginning on January 1, 2019 and ending on and including January 1, 2028, by an amount equal to the lesser of (i) 1% of the aggregate number of shares of common stock outstanding on the final day of the immediately preceding calendar year and (ii) such smaller number of shares of common stock as is determined by Homology’s board of directors, provided that no more than 4,778,738 shares of our common stock may be issued under the 2018 ESPP.

Required Vote

The affirmative vote of the holders of a majority in voting power of the votes cast affirmatively or negatively at the Homology Special Meeting by the holders entitled to vote on the matter is required to approve the Stock Option and Incentive Plan Proposal.

HOMOLOGY’S BOARD OF DIRECTORS RECOMMENDS A VOTE “FOR” THIS PROPOSAL NO. 4 TO APPROVE THE 2024 STOCK OPTION AND INCENTIVE PLAN.

Unless otherwise instructed, it is the intention of the persons named in the accompanying proxy statement/prospectus to vote shares “FOR” the approval of the Stock Option and Incentive Plan Proposal.

 

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PROPOSAL NO. 5: APPROVAL OF THE 2024 EMPLOYEE STOCK PURCHASE PLAN

Overview

As discussed in this proxy statement/prospectus, Homology is asking its stockholders to consider and vote upon a proposal to approve the Q32 Inc. 2024 Employee Stock Purchase Plan, or the 2024 ESPP, a copy of which is attached to this proxy statement/prospectus as Annex J, or the ESPP Proposal.

If the 2024 ESPP becomes effective, then no additional awards will be granted under the Homology 2018 Employee Stock Purchase Plan, or the Homology ESPP. If the 2024 ESPP does not become effective, the Homology ESPP will remain in full force and effect and available for the grant of awards thereunder.

Reasons to Approve the 2024 ESPP

The purpose of the 2024 ESPP is to provide employees of the combined company with an opportunity to acquire shares, which will enable the combined company to attract, retain and motivate valued employees. Approval of the 2024 ESPP by Homology’s stockholders is required, among other things, in order to comply with stock exchange rules requiring stockholder approval of equity compensation plans. A component of the 2024 ESPP is intended to qualify as an “employee stock purchase plan” under Section 423 of the Code. If the 2024 ESPP is approved by Homology’s stockholders, the 2024 ESPP will become effective as of the Effective Time and the combined company will register the necessary shares of its common stock on a Registration Statement on Form S-8.

A total of                shares (before giving effect to the proposed Reverse Stock Split) will be reserved for issuance under the 2024 ESPP. As of , the closing price on Nasdaq per share of Homology common stock was $        . Based upon a price per share of $        , the maximum aggregate market value that could potentially be issued under the 2024 ESPP at the Effective Time is $        . The Homology board of directors approved the 2024 ESPP on            , 2024, subject to approval by Homology’s stockholders. If the 2024 ESPP is approved by Homology’s stockholders, the 2024 ESPP will become effective at the Effective Time.

The following is a summary of the material features of the 2024 ESPP. This summary is qualified in its entirety by the full text of the 2024 ESPP, a copy of which is included as Annex J to this proxy statement/prospectus.

Summary of the Material Provisions of the 2024 ESPP

An aggregate of                shares (before giving effect to the proposed Reverse Stock Split), or the Initial Reserve, will be reserved and available for issuance under the 2024 ESPP. The 2024 ESPP provides that the number of shares reserved and available for issuance under the plan will automatically increase each January 1, beginning on January 1, 2025, by the lesser of a number of shares equal to the Initial Reserve, 1% of the outstanding number of shares on the immediately preceding December 31, or such lesser amount as determined by the plan administrator. If the combined company’s capital structure changes because of a stock dividend, stock split or similar event, the number of shares that can be issued under the 2024 ESPP will be appropriately adjusted.

The 2024 ESPP will be administered by the person or persons appointed by the combined company’s board of directors. Initially, the compensation committee of the combined company’s board of directors will administer the plan and will have full authority to make, administer and interpret such rules and regulations regarding the 2024 ESPP as it deems advisable.

Any employee of the combined company or one of its subsidiaries that has been designated to participate in the 2024 ESPP is eligible to participate in the 2024 ESPP so long as the employee is customarily employed for more than 20 hours a week. No person who owns or holds, or as a result of participation in the 2024 ESPP would

 

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own or hold, shares or options to purchase shares, that together equal to 5% or more of total combined voting power or value of all classes of stock of the combined company or any parent or subsidiary is entitled to participate in the 2024 ESPP. No employee may exercise an option granted under the 2024 ESPP that permits the employee to purchase shares having a value of more than $25,000 (determined using the fair market value of the stock at the time such option is granted) in any calendar year.

Participation in the 2024 ESPP is limited to eligible employees who authorize payroll deductions equal to a whole percentage of base pay to the 2024 ESPP. Employees may authorize payroll deductions, with a minimum of 1% of base pay and a maximum of 15% of base pay.

Immediately following completion of the Merger, the combined company is expected to have a total of approximately                employees who will be eligible participate the 2024 ESPP. Once an employee becomes a participant in the 2024 ESPP, that employee will automatically participate in successive offering periods, as described below, until such time as that employee withdraws from the 2024 ESPP, becomes ineligible to participate in the 2024 ESPP, or his or her employment ceases.

The combined company may make one or more offerings under the 2024 ESPP, consisting of one or more purchase periods, for employees to purchase shares under the 2024 ESPP, which is referred to as an “offering period.” The plan administrator may, in its discretion, determine when each offering shall occur, including the duration of any offering period; provided, that no offering period will exceed 27 months in duration. Shares are purchased on the last day of each purchase period or if such purchase period is the last purchase period of the offering period, the last day of such offering period, with that day being referred to as an “exercise date.” Unless otherwise determined by the plan administrator, participants will only be permitted to participate in one offering at a time.

On the first day of an offering period, employees participating in that offering period will be granted an option to purchase shares. On the exercise date of each purchase period, the employee is deemed to have exercised the option, at the exercise price, for the lowest of (i) a number of shares determined by dividing such employee’s accumulated payroll deductions or contributions on such exercise date by the exercise price; (ii) a number of shares determined by dividing $25,000 by the fair market value per share on the first day of the offering period; or (iii) such lesser number as established by the plan administrator in advance of the offering. The exercise price is equal to the lesser of (i) 85% the fair market value per share on the first day of the offering period or (ii) 85% of the fair market value per share on the exercise date. The maximum number of shares that may be issued to any employee under the 2024 ESPP in a calendar year is a number of shares determined by dividing $25,000, valued at the start of the offering period, or such other lesser number of shares as determined by the plan administrator from time to time.

In general, if an employee is no longer a participant on an exercise date, the employee’s option will be automatically terminated, and the amount of the employee’s accumulated payroll deductions will be refunded.

Except as may be permitted by the plan administrator in advance of an offering, a participant may not increase or decrease the amount of his or her payroll deductions during any offering period but may increase or decrease his or her payroll deduction with respect to the next offering period by filing a new enrollment form at least 15 business days before the first day of such offering period, or such other deadline established by the plan administrator. A participant may withdraw from an offering period at any time without affecting his or her eligibility to participate in future offering periods. If a participant withdraws from an offering period, that participant may not again participate in the same offering period, but may enroll in subsequent offering periods. An employee’s withdrawal will be effective as of the next business day following the date that the plan administrator receives the employee’s written notice of withdrawal under the 2024 ESPP.

In the case of and subject to the consummation of a “sale event,” the plan administrator, in its discretion, and on such terms and conditions as it deems appropriate, is hereby authorized to take any one or more of the

 

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following actions under the 2024 ESPP or with respect to any right under the 2024 ESPP or to facilitate such transactions or events: (a) to provide for either (i) termination of any outstanding option in exchange for an amount of cash, if any, equal to the amount that would have been obtained upon the exercise of such option had such option been currently exercisable or (ii) the replacement of such outstanding option with other options or property selected by the plan administrator in its sole discretion; (b) to provide that the outstanding options under the 2024 ESPP shall be assumed by the successor or survivor corporation, or a parent or subsidiary thereof, or shall be substituted for similar options covering the stock of the successor or survivor corporation, or a parent or subsidiary thereof, with appropriate adjustments as to the number and kind of shares and prices; (c) to make adjustments in the number and type of shares (or other securities or property) subject to outstanding options under the 2024 ESPP and/or in the terms and conditions of outstanding options and options that may be granted in the future; (d) to provide that the offering with respect to which an option relates will be shortened by setting a new exercise date on which such offering will end; and (e) to provide that all outstanding options shall terminate without being exercised and all amounts in the accounts of participants shall be promptly refunded.

The 2024 ESPP will automatically terminate on the 10-year anniversary of the Effective Time. The combined company’s board of directors may, in its discretion, at any time, terminate or amend the 2024 ESPP.

Form S-8

Following the Effective Time and subject to the approval of the 2024 ESPP by Homology’s stockholders, the combined company will file with the SEC a registration statement on Form S-8 covering the shares issuable under the 2024 ESPP.

Certain U.S. Federal Income Tax Consequences

The following is only a summary of the effect of the U.S. income tax laws and regulations upon an employee and the combined company with respect to an employee’s participation in the 2024 ESPP. This summary does not purport to be a complete description of all federal tax implications of participation in the 2024 ESPP, nor does it discuss the income tax laws of any municipality, state or foreign country in which a participant may reside or otherwise be subject to tax.

A participant in the 2024 ESPP generally recognizes no taxable income either as a result of participation in the 2024 ESPP or upon exercise of an option to purchase shares under the terms of the 2024 ESPP.

If a participant disposes of shares purchased upon exercise of an option granted under the 2024 ESPP within two years from the first day of the applicable offering period or within one year from the exercise date, which is referred to as a “disqualifying disposition,” the participant will generally recognize ordinary income in the year of that disposition equal to the amount by which the fair market value of the shares on the date the shares were purchased exceeds the purchase price. The amount of ordinary income will be added to the participant’s basis in the shares, and any additional gain or resulting loss recognized on the disposition of the shares will be a capital gain or loss. A capital gain or loss will generally be long-term if the participant’s holding period is more than 12 months, or short-term if the participant’s holding period is 12 months or less.

If the participant disposes of shares purchased upon exercise of an option granted under the 2024 ESPP at least two years after the first day of the applicable offering period and at least one year after the exercise date, the participant will recognize ordinary income in the year of disposition equal to the lesser of (1) the excess of the fair market value of the shares at the time the option was granted over the amount paid and (2) the excess of the amount actually received for the shares over the amount paid. The amount of any ordinary income will be added to the participant’s basis in the shares, and any additional gain recognized upon the disposition after that basis adjustment will be a long-term capital gain. If the fair market value of the shares on the date of disposition is less than the exercise price, there will be no ordinary income and any loss recognized will be a long-term capital loss.

 

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The combined company is generally entitled to a tax deduction in the year of a disqualifying disposition equal to the amount of ordinary income recognized by the participant as a result of that disposition. In all other cases, the combined company is not allowed a deduction.

New Plan Benefits

Because participation in the 2024 ESPP is voluntary, the benefits or amounts that will be received by or allocated to any individual or group of individuals under the 2024 ESPP in the future are not determinable and no awards have been granted that are contingent on stockholder approval of the 2024 ESPP.

Interests of Certain Persons in this Proposal

The existence of financial and personal interests of one or more of Homology’s directors may result in a conflict of interest on the part of such director(s) between what he or she may believe is in the best interests of Homology and its stockholders and what he or she may believe is best for himself or herself in determining to recommend that stockholders vote for the proposals. In addition, Homology’s officers have interests in the Merger that may conflict with the interests of Homology’s stockholders. See the section entitled “The Merger—Interests of Homology Directors and Executive Officers in the Merger” for a further discussion of these considerations.

Required Vote

The affirmative vote of the holders of a majority in voting power of the votes cast affirmatively or negatively at the Homology Special Meeting by the holders entitled to vote on the matter is required to approve the ESPP Proposal.

HOMOLOGY’S BOARD OF DIRECTORS RECOMMENDS A VOTE “FOR” THIS PROPOSAL NO. 5 TO APPROVE THE 2024 EMPLOYEE STOCK PURCHASE PLAN.

Unless otherwise instructed, it is the intention of the persons named in the accompanying proxy statement/ prospectus to vote shares “FOR” the approval of the ESPP Proposal.

 

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PROPOSAL NO. 6: APPROVAL OF ADJOURNMENT OF THE HOMOLOGY SPECIAL MEETING

If Homology fails to receive a sufficient number of votes to approve the Stock Issuance Proposal, the Authorized Share Increase Proposal and the Reverse Stock Split Proposal, Homology may propose to adjourn the Homology Special Meeting, for a period of not more than 30 days, for the purpose of soliciting additional proxies to approve the Stock Issuance Proposal, the Authorized Share Increase Proposal and the Reverse Stock Split Proposal. Homology currently does not intend to propose adjournment at the Homology Special Meeting if there are sufficient votes to approve the Stock Issuance Proposal, the Authorized Share Increase Proposal and the Reverse Stock Split Proposal.

Required Vote

The affirmative vote of a majority in voting power of the votes cast affirmatively or negatively in attendance or represented by proxy at the Homology Special Meeting and entitled to vote on the matter is required to approve the adjournment of the Homology Special Meeting for the purpose of soliciting additional proxies to approve the Stock Issuance Proposal, the Authorized Share Increase Proposal and the Reverse Stock Split Proposal.

HOMOLOGY’S BOARD OF DIRECTORS RECOMMENDS A VOTE “FOR” THIS PROPOSAL NO. 6 TO ADJOURN THE HOMOLOGY SPECIAL MEETING, IF NECESSARY, TO SOLICIT ADDITIONAL PROXIES IF THERE ARE NOT SUFFICIENT VOTES IN FAVOR OF THE STOCK ISSUANCE PROPOSAL, THE AUTHORIZED SHARE INCREASE PROPOSAL AND THE REVERSE STOCK SPLIT PROPOSAL.

Unless otherwise instructed, it is the intention of the persons named in this proxy statement/prospectus to vote shares “FOR” the ratification to adjourn the Homology Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of the Stock Issuance Proposal, the Authorized Share Increase Proposal and the Reverse Stock Split Proposal.

 

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HOMOLOGY’S BUSINESS

Overview

Homology is a clinical-stage genetic medicines company historically focused on transforming the lives of patients suffering from rare genetic diseases with significant unmet medical needs by addressing the underlying cause of the disease. Homology’s proprietary platform is designed to utilize its human hematopoietic stem cell-derived adeno-associated virus vectors, or AAVHSCs, to precisely and efficiently deliver single administration genetic medicines in vivo through a nuclease-free gene editing modality, gene therapy, or gene therapy to express antibodies platform, or GTx-mAb, which is designed to produce antibodies throughout the body.

In July 2023, Homology completed a review of its business and its Board of Directors approved a plan to explore, review and evaluate a range of potential strategic options available to it, including, without limitation, an acquisition, merger, reverse merger, sale of assets, strategic partnerships or other transactions. Based on the financing environment and the anticipated clinical development timeline for its lead program, HMI-103, Homology stopped further development of its programs and reduced its workforce by 86% to significantly reduce its ongoing operating costs as it evaluated strategic alternatives.

After a comprehensive review of strategic alternatives, on November 16, 2023, Homology entered into an Agreement and Plan of Merger, or the Merger Agreement, with Q32 Bio Inc., a Delaware corporation, or Q32, and Kenobi Merger Sub, Inc., a Delaware corporation and Homology’s direct, wholly owned subsidiary, or Merger Sub, pursuant to which, among other matters, and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, Merger Sub will merge with and into Q32, with Q32 continuing as Homology’s wholly owned subsidiary and the surviving corporation of the merger, or the Merger. Homology’s future operations are highly dependent on the success of the Merger and there can be no assurance that the Merger will be successfully consummated. If the Merger is completed, the business of Q32 will continue as the business of the combined company.

Homology’s former clinical programs include: HMI-103, an investigational gene editing candidate for the treatment of patients with phenylketonuria, or PKU, HMI-203, an investigational gene therapy candidate for the treatment of patients with mucopolysaccharidosis type II (MPS II), or Hunter syndrome, and HMI-102, an investigational gene therapy candidate for the treatment of adult patients with PKU. Homology’s former preclinical programs include: HMI-104, a GTx-mAb gene therapy candidate for the treatment of patients with paroxysmal nocturnal hemoglobinuria, or PNH, and HMI-204, a gene therapy candidate for metachromatic leukodystrophy, or MLD. Homology is currently exploring strategic alternatives for HMI-103 (Adult/Pediatric PKU), HMI-204 (MLD) and Homology’s Capsids and AAVHSC Platform, including the sale of these programs.

In August 2023, Homology withdrew its Clinical Trial Application, or CTA, for HMI-203 in Canada. In September 2023, Homology withdrew its IND for HMI-102 (Adult PKU), which the FDA formally acknowledged in November 2023. Also in September 2023, Homology requested that the FDA place its HMI-103 (Adult/Pediatric PKU) program on inactive status, which request remains pending. In December 2023, Homology withdrew its IND for HMI-203 (Hunter Syndrome). All clinical trial sites have been notified that all studies conducted by Homology for its programs have been terminated and have been duly notified of their responsibilities. Homology has also withdrawn all orphan drug designations for its programs in both the United States and the EU.

Clinical Programs

In September 2023, Homology inactivated its pheEDIT Phase 1 gene editing clinical trial evaluating HMI-103 in adults with classical PKU (NCT05222178). In October 2023, Homology reported clinical data from the first dose cohort in the pheEDIT trial. As of the data cut-off date of September 14, 2023, HMI-103 was generally well-tolerated in all three participants with no serious adverse events, and the majority of treatment-related adverse events were mild

 

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and transient. All liver function tests remained in the normal range during the prophylactic immunosuppression regimen incorporating the T-cell inhibitor tacrolimus in combination with corticosteroid. Participant 1 experienced a reduction in plasma phenylalanine, or Phe, levels to below the U.S. American College of Medical Genetics and Genomics PKU treatment guideline threshold of <360 µmol/L, and the majority of Phe levels were below 360 mmol/L through 39 weeks post-dose, including after the initiation of dietary protein supplementation. Participant 2 experienced a meaningful plasma Phe reduction of 50% at 23 weeks post-dose. Participant 3 experienced a meaningful plasma Phe reduction of 60% at 14 weeks post-dose.

In August 2023, Homology terminated both its pheNIX Phase 1/2 gene therapy clinical trial evaluating HMI-102 in adults with classical PKU and its juMPStart Phase 1 gene therapy clinical trial evaluating HMI-203 in adults with Hunter Syndrome. INDs for both the pheNIX Phase 1/2 and juMPStart Phase 1 clinical trials have been withdrawn.

Earlier-Stage Product Candidates

Homology completed IND-enabling studies with HMI-202, an investigational gene therapy for the treatment of patients with MLD. Applying the learnings from these IND-enabling studies, in August 2022, Homology announced the details of HMI-204, an optimized, in vivo, one-time gene therapy product candidate for the treatment of MLD. Following a single I.V. administration in the MLD murine model, this optimized candidate, which uses one of Homology’s proprietary AAVHSC capsids, crossed the blood-brain-barrier to the CNS and reached key peripheral organs involved in MLD. This resulted in expression of human ARSA, or hARSA, levels in multiple brain regions and cell types above the minimum level of enzyme needed to correct the MLD disease phenotype, hARSA activity levels in the brain predictive of functional assay improvements and hARSA activity in the serum. Additionally, these optimizations led to significant improvements in vector yield and superior packaging for the product candidate.

HMI-104 was a candidate for PNH from Homology’s GTx-mAb platform. This platform represents an additional way that Homology could potentially leverage its AAVHSCs in an effort to deliver one-time in vivo gene therapy to express and secrete antibodies from the liver, which it believes may allow it to target diseases with larger patient populations. In support of this program, Homology generated and presented preclinical data targeting complement protein 5, demonstrating preclinical proof-of-concept in PNH. A single I.V. dose of an AAVHSC GTx-mAb showed expression of full-length antibodies from the liver consistent with levels associated with anti-C5 therapeutics, sustained and robust Immunoglobulin G, or IgG, expression in vivo in a humanized murine liver model and a murine NOD-SCID model, and in vivo vector-expressed C5 mAb had potent functional activity as shown by an ex vivo hemolysis assay. Additionally, Homology observed sustained expression of C5 mAb in the presence of murine and human neonatal fragment crystallizable (Fc) receptor, or FcRn. Homology completed IND-enabling studies with HMI-104.

Oxford Biomedica Solutions Transaction

On March 10, 2022, Homology closed a transaction with Oxford Biomedica Solutions LLC (f/k/a Roadrunner Solutions LLC), or OXB Solutions, Oxford Biomedica (US), Inc., or OXB, and Oxford Biomedica plc, or OXB Parent, and collectively with OXB, Oxford, pursuant to the Equity Securities Purchase Agreement, or the Purchase Agreement, dated as of January 28, 2022, by and among Homology, OXB Solutions and Oxford, whereby, among other things, Homology and Oxford agreed to collaborate to operate OXB Solutions, which provides AAV vector process development and manufacturing services to biotechnology companies, which Homology refers to as the Oxford Biomedica Solutions Transaction, or the OXB Solutions Transaction. OXB Solutions incorporates Homology’s proven ‘plug and play’ process development and manufacturing platform, as well as its experienced team and high-quality GMP vector production capabilities that was built and operated since 2019.

Pursuant to the terms of the Purchase Agreement and a contribution agreement, or the Contribution Agreement, entered into between Homology and OXB Solutions prior to the closing of the OXB Solutions

 

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Transaction, or the Closing, Homology agreed to assign and transfer to OXB Solutions all of its assets that are primarily used in the manufacturing of AAV vectors for use in gene therapy or gene editing products, but excluding certain assets related to manufacturing or testing of its proprietary AAV vectors, or collectively, the Transferred Assets, in exchange for 175,000 common equity units in OXB Solutions, or Units, and OXB Solutions assumed from Homology, and agreed to pay, perform and discharge when due, all of Homology’s duties, obligations, liabilities, interests and commitments of any kind under, arising out of or relating to the Transferred Assets.

Effective as of the Closing, Homology sold to OXB, and OXB purchased from Homology, 130,000 Units, or the Transferred Units, in exchange for $130.0 million. In connection with the Closing, OXB contributed $50.0 million in cash to OXB Solutions in exchange for an additional 50,000 Units. Immediately following the Closing, (i) OXB owned 180,000 Units, representing 80 percent (80%) of the fully diluted equity interests in OXB Solutions, and (ii) Homology owned 45,000 Units, representing 20 percent (20%) of the fully diluted equity interests in OXB Solutions.

Pursuant to the Amended and Restated Limited Liability Company Agreement of OXB Solutions, or the OXB Solutions Operating Agreement, which was executed in connection with the Closing, at any time following the three-year anniversary of the Closing, (i) OXB has an option to cause Homology to sell and transfer to OXB, and (ii) Homology has an option to cause OXB to purchase from Homology, in each case all of Homology’s equity ownership interest in OXB Solutions at a price equal to 5.5 times the revenue for the immediately preceding 12-month period, subject to a maximum amount of $74.1 million. Pursuant to the terms of the OXB Solutions Operating Agreement, Homology is entitled to designate one director on the board of directors of OXB Solutions, currently Paul Alloway, Ph.D., Homology’s President and Chief Operating Officer.

Concurrently with the Closing, Homology entered into certain ancillary agreements with OXB Solutions including a license and patent management agreement whereby OXB Solutions granted certain licenses to Homology, a supply agreement, or the Supply Agreement, for a term of three years which includes certain annual minimum purchase commitments, a lease assignment pursuant to which Homology assigned all of its right, title and interest in, to and under its facility lease to OXB Solutions, a sublease agreement whereby OXB Solutions subleased certain premises in its facility to Homology, as well as several additional ancillary agreements.

Corporate Headquarters Lease

In November 2021, Homology entered into an amendment of its December 2017 lease agreement, or the Lease Amendment, for its corporate headquarters in Bedford, Massachusetts. The Lease Amendment increases the space under lease by approximately 23,011 square feet, or the Expansion Premises, and extends the expiration date of the existing premises under the lease from February 2027 to June 2030. The term with respect to the Expansion Premises commenced on May 1, 2022 and continues for a period of ten years and five months. The term of the Expansion Premises and the existing premises are not coterminous. Annual base rent for the existing premises under the Lease Amendment is approximately $4.7 million beginning on March 1, 2027, and increases by three percent annually; annual base rent for the Expansion Premises is approximately $1.4 million per year and increases by three percent annually. The Lease Amendment allows for tenant improvement allowances not to exceed $6.3 million in the aggregate. Under the terms of the agreement with Oxford, Homology’s lease for its corporate headquarters, including the Expansion Premises, has been assigned to OXB Solutions with Homology subleasing a portion of lab and office space back from the newly created company until December 31, 2024. Homology was released from being primary obligor under such lease, effective as of October 1, 2023. See Notes 9 and 13 to Homology’s unaudited condensed consolidated financial statements included elsewhere in this proxy statement/prospectus for additional information regarding Homology’s lease agreement.

License Agreements

In April 2016, Homology entered into an exclusive license agreement with City of Hope, or COH, pursuant to which COH granted Homology an exclusive, sublicensable, worldwide license, or the COH License, to certain

 

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AAV vector-related patents and know-how owned by COH to develop, manufacture, use and commercialize products and services covered by such patents and know-how in any and all fields. On August 6, 2021, Homology received notice from COH that Homology did not accomplish at least one of the partnering milestones by the applicable deadline, as set forth in the COH License. This notice does not affect Homology’s exclusive license in the field of mammalian therapeutics, including all human therapeutics, associated diagnostics, and target validation, or the Mammalian Therapeutic Field, where Homology retains exclusive rights. Instead, the notice served as written notice that the exclusive license granted pursuant to the COH License in all fields except the Mammalian Therapeutic Field converted from exclusive to non-exclusive effective as of September 20, 2021, which was forty-five days from the receipt of notice. In connection with the conversion, any royalty obligations and sublicensee fees relating to fields outside of the Mammalian Therapeutic Field shall be reduced by a certain percentage. This change to Homology’s exclusive worldwide license with COH does not impact any of Homology’s therapeutic product development candidates, including HMI-102, HMI-103, HMI-203, HMI-204 and HMI-104.

Financial Overview

Since its inception in 2015 through September 30, 2023, Homology has raised approximately $721 million in aggregate net proceeds through its initial public offering, or IPO, in April 2018, follow-on public offerings of common stock in April 2019 and April 2021, proceeds from the sale of common stock under an “at-the-market” sales agreement, equity investments from pharmaceutical companies, preferred stock financings and Homology’s agreement with Oxford. Included in Homology’s net proceeds is a $130.0 million up-front cash payment from its agreement with Oxford, $50.0 million from a former collaboration partner, comprised of an up-front payment of $35.0 million and a $15.0 million equity investment, and a $60.0 million equity investment from Pfizer Inc., or Pfizer, through a private placement transaction. Should Homology resume development of one or more of its product candidates, it will require additional capital in order to advance its product candidates through clinical development and commercialization.

Homology’s Opportunity in Genetic Medicines

Homology was historically focused on monogenic diseases where the genetic abnormality is known to occur in a single gene. The majority of monogenic diseases harbor thousands of individual mutations within the diseased gene, each resulting in a loss of function. Adding a functional gene to the cell where there is a missing or mutated gene (gene therapy), replacing an entire diseased gene with a whole functional gene (gene editing), or expressing an antibody to address the underlying genetic disease mechanism (GTx-mAb), are the optimal therapeutic approaches for addressing these monogenic disorders. This can be accomplished either through a method of gene therapy called gene transfer in slowly or non-dividing cells, or through a method of gene editing called gene integration in rapidly dividing cells.

The current focus of most nuclease-based gene editing companies is gene knockout, or knocking out a diseased gene to prevent the expression of an undesired protein. Since gene knockout does not result in a fully-corrected gene, this method can only potentially address the minority of monogenic diseases where a diseased protein requires knock-down or inactivation. Homology’s HR-driven gene editing approach aims to achieve functional gene integration into the patient’s genome and potentially address the majority of monogenic diseases by replacing an entire diseased gene with a whole functional gene. Homology’s gene therapy approach, on the other hand, seeks to introduce a functional copy of a defective gene into a patient’s own cells, but not incorporate such copy into the patient’s genome. This method results in the expression of the therapeutic protein of interest without changing the genome.

DNA Repair Pathways

Human cells harbor two primary independent pathways to maintain the integrity of DNA: homologous recombination, or HR, and non-homologous end joining, or NHEJ, which are described below:

 

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HR is a process in which cells repair DNA through highly precise incorporation of correct DNA sequences that are homologous, or matching, to the site of damage. HR has evolved to repair DNA

 

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with high fidelity and avoids the introduction of unwanted mutations at the site of correction. In the late 1990s, researchers discovered that certain AAV vectors delivered long single strands of homologous DNA to specific regions in the genome and induced the HR pathway, but their low efficiency of approximately 1% limited their use as a viable option for in vivo therapeutics.

 

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NHEJ is a less selective, error-prone process that rapidly joins the ends of broken DNA resulting in a high frequency of insertions or deletions at the break site. The discovery of nuclease-based gene editing technologies provided researchers with novel tools to specifically introduce DNA breaks into the genome. Despite high potential for error, the majority of nuclease-based gene editing approaches primarily utilize the NHEJ pathway.

Homology believes the major limitation of nuclease-based gene editing is the preferential utilization of the error-prone NHEJ pathway instead of the HR pathway. Because of this preference, the greatest utility of nuclease-based gene editing technologies may lie in their ability to knockout genes rather than replace an entire diseased gene in the genome with a whole functional copy. Furthermore, the use of nuclease-based gene editing technologies for insertion of a corrective sequence carries the risk of unwanted mutations from NHEJ including insertions and deletions or opposite orientation insertion of the template DNA, and also requires the separate delivery of both the nuclease and the DNA template to the same location at the same time.

Homology believes the unique characteristics of its genetic medicines platform will allow it to focus on the HR pathway, enabling precise nuclease-free gene integration with improved efficiency and a broader set of disease targets.

Homology’s Platform & Approach

In developing a genetic medicine product candidate, Homology’s strategy was to choose the AAVHSC that reaches the area(s) of the body needed to address the specific disease Homology was targeting. Homology then designed the product candidate to precisely and efficiently deliver genetic medicines following a one-time I.V. infusion (in vivo) using a gene therapy, nuclease-free gene editing, or GTx-mAb modality. Refer to Figure 1 below for a graphical depiction of Homology’s platform.

 

LOGO

Figure 1. Homology’s Genetic Medicines Platform.

Homology’s novel AAVHSCs are packaged with either a gene therapy or a gene editing construct. Homology’s gene therapy construct includes a functional copy of the gene and a promoter sequence that is designed to enable the gene to be turned on in the cell and ultimately transcribed to express the therapeutic protein of interest without integrating into the genome. Homology’s gene editing construct includes lengthy guide sequences, or homology arms, which are designed to enable the specific alignment to the desired genomic location and then, through the natural process of HR, enable correction of the diseased gene in the genome by replacement with a whole functional copy. Homology’s GTx-mAb platform is an extension of Homology’s gene therapy approach. It is designed to utilize AAVHSCs to deliver therapeutic DNA for heavy chain and light chain antibody proteins that can be delivered to the liver where they form fully functional, full-length Immunoglobulin G (IgG) antibodies and are secreted throughout the body.

 

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While others are working on identifying and testing ways to mitigate the inherent risk in working with nucleases for gene editing, Homology’s approach avoids the use of nucleases entirely. By targeting the HR pathway, Homology’s proprietary AAVHSCs mitigate the risks of nuclease-based technologies and have the potential to overcome other AAV vector limitations by combining the precision and high fidelity of HR with highly efficient in vivo gene integration, which Homology believes is capable of providing potential cures for a wide range of rare genetic diseases. Refer to Figure 2 below for a graphical depiction of how Homology’s AAVHSCs are designed to enable each therapeutic modality.

 

 

LOGO

Figure 2. How Homology’s AAVHSCs are designed to enable each therapeutic modality.

Homology believes its approach has several key advantages, including:

 

  •  

Homology’s proprietary AAVHSC platform enables a nuclease-free gene editing modality, gene therapy, or GTx-mAb. Homology’s platform provides it the flexibility to deliver genetic medicines through the best suited modality for each disease it pursues based on such factors as the targeted disease biology, the biodistribution of its AAVHSCs to key tissues, and the rate of cell division the tissues exhibit. Homology’s AAVHSCs are naturally occurring as they were originally isolated from normal human CD34 cells and have the potential to result in an improved safety profile.

 

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Ability to perform nuclease-free gene editing mediated by HR with gene integration efficiencies that achieve therapeutic ranges. Homology’s family of 15 novel AAVHSCs are designed to enable it to take advantage of the precise and high-fidelity process of HR-directed gene insertion for nuclease-free gene editing while achieving gene integration efficiencies that Homology believes are in therapeutic ranges and significantly higher than both nuclease-based and other AAV-based approaches. While nuclease-based gene editing technologies have achieved high gene knockout efficiencies in preclinical studies, which is only potentially useful for the minority of monogenic diseases, they have shown limited published evidence of gene integration efficiencies to date.

 

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Ability to introduce an entire gene into the genome or the precise repair of individual mutated nucleotides in addition to gene knockout. Homology’s HR-based gene editing approach provides the flexibility to introduce an entire copy of a functional gene into the genome also known as gene integration, in addition to repairing single mutations or knocking out entire genes, thus allowing Homology to potentially address the significant majority of monogenic diseases.

 

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  •  

High precision and lack of unwanted off-target or on-target DNA modifications. Homology’s gene editing approach leverages HR, which makes DNA repairs with high fidelity, and enables Homology to precisely perform gene integration without unwanted off- and on-target modifications. Furthermore, Homology is able to directly measure and confirm those modifications throughout the entire genome to ensure only the intended changes are made.

 

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Ability to target multiple tissues. In preclinical studies, intravenous administration of Homology’s family of AAVHSCs has demonstrated unique biodistribution properties across the serotypes and the ability to target a wide variety of tissues including the liver, CNS, including the ability to cross the blood-brain-barrier, PNS, muscle, bone marrow, eye and heart, enabling Homology to potentially address a broad range of monogenic diseases. The diversity of Homology’s AAVHSC library of capsids can also be expanded through targeted shuffling of the capsid sequences.

 

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In vivo administration with a single component delivery system. Homology’s platform is designed to perform gene editing at high efficiency without the use of a nuclease, enabling Homology to deliver genetic medicines in vivo using a single vector system that contains everything required to edit DNA. These characteristics simplify the manufacturing and delivery of Homology’s therapeutic candidates relative to existing nuclease-based gene editing approaches.

 

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Ability to target a broad range of patients given low frequency of pre-existing neutralizing antibodies. Homology believes its AAVHSCs can target a broad range of patient populations given the low prevalence of pre-existing neutralizing antibodies relative to other AAV vectors.

Homology’s Former Pipeline Strategy

Homology initially pursued monogenic diseases where it knew exactly what it was seeking to correct and exactly which gene to insert into patients’ cells, including delivery via Homology’s GTx-mAb platform to express and secrete antibodies from the liver. Homology prioritized monogenic diseases with significant unmet medical needs, validated regulatory pathways, well-accepted biomarkers and significant commercial opportunities. Homology was formerly focused on developing product candidates to treat monogenic diseases in the liver, CNS and peripheral tissues, bone marrow, and the eye, given that Homology’s AAVHSCs naturally show a high degree of tropism or ability to enter cells in these organs and organ systems. These tissues are affected in many rare genetic diseases.

Homology’s initial focus areas included developing product candidates for intracellular, inborn errors of metabolism and other genetic conditions that are especially well-suited to correction by its gene editing or gene therapy methods. In slow- or non-dividing cells (e.g., CNS and adult liver cells), gene therapy can potentially be curative, while rapidly dividing cells (e.g., hematopoietic CD34+ cells and pediatric liver cells) require a gene editing approach to provide a permanent correction in the genome that can be replicated with each cell division. Homology was purposefully deploying its proprietary AAVHSCs in certain indications first with a gene therapy approach followed by a gene editing approach, in order to maximize the likelihood of translating its platform into widespread clinical and commercial success.

Homology believes that it has validated its AAVHSC platform in the liver based on the results observed in the dose-escalation portion of its Phase 1/2 trial with HMI-102, and in the first dose cohort of its Phase 1 trial with HMI-103. Homology completed a comprehensive in vivo biodistribution study in NHPs in which all 11 of the AAVHSCs tested crossed the blood-brain-barrier and the blood-nerve-barrier.

Homology’s Genetic Medicines Platform

Homology’s proprietary genetic medicines platform is built on its novel AAVHSCs, which allow Homology to choose the best-suited modality from either a gene therapy, nuclease-free gene editing, or GTx-mAb modality for each disease it pursues, based on such factors as the targeted disease biology, the biodistribution of

 

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Homology’s AAVHSCs to key tissues, and the rate of cell division the target tissues exhibit. The unique characteristics of Homology’s platform enable nuclease-free gene editing, specifically gene integration, and broad, systemic tissue distribution. Homology’s AAVHSCs are designed to directly integrate corrective DNA through HR with therapeutically relevant efficiencies. Homology’s HR-based gene editing approach utilizes a single component AAV system that contains everything required to selectively edit DNA with no need for exogenous nucleases or editing machinery. This single-component system simplifies the manufacturing and delivery of Homology’s therapeutics. Homology believes its gene editing approach has the potential to be curative as it provides a permanent correction in the genome that is then replicated with each cell division so that new generations of cells will carry the corrected gene. Homology’s AAVHSCs are naturally occurring and have been modified to be non-replicating to minimize potential safety issues. Homology believes its platform’s combined attributes will allow for more efficient and safer therapeutics for a wide range of genetic diseases.

Homologous Recombination—A Powerful Basis for Gene Editing

Homology’s technology is based on the natural DNA repair process of HR and is designed to enable precise and efficient gene integration without an exogenous nuclease.

Homology’s genetic medicines platform induces the endogenous HR cellular process using its AAVHSCs to insert replacement or corrective genes into cells that contain mutated or deleterious genes (refer to Figure 3 below). Homology engineers its AAVHSCs to contain long, single-stranded DNA corrective sequences highly specific to the target region in the genome. These single-stranded DNA molecules are then delivered to cells in Homology’s AAVHSC vectors, which Homology believes results in precise and efficient gene integration via the HR pathway. The design of Homology’s long and specific sequences, up to the 4.7 kilobase packaging limit of Homology’s AAVHSCs, is intended to significantly reduce the risk of off-target integration. Based on the packaging size of its AAVHSCs, Homology believes its capsids are capable of accommodating and delivering up to approximately 85% of the genes in the human genome and thus have the ability to address a significant majority of genetic disorders. Homology typically uses homology arms as long as 1,600 base pairs of DNA to target corrective gene sequences into precise regions of the genome, in contrast to the guide sequences used in CRISPR/Cas 9-based gene editing, which are typically less than 30 base pairs in length. Homology also benefits from the ability of its platform to utilize HR to precisely insert gene sequences into the DNA of cells, similar to how mammalian cells repair their own DNA. In order to bring about the excision and subsequent replacement that some forms of gene editing require, those other approaches must combine multiple additional techniques and deliver into the cell the requisite cellular machinery at the right place at the same time, increasing the complexity of the task, introducing the possibility of integrating the wrong DNA due to non-HR-based repair mechanisms, and reducing the likelihood of success.

 

 

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LOGO

Figure 3. Schematic of homologous recombination.

Homology’s Proprietary AAVHSCs

Homology’s genetic medicines platform is based on a family of 15 proprietary AAVHSCs which it can deploy with a gene therapy, gene editing or GTx-mAb construct. Homology has the opportunity to expand on this family through capsid shuffling. Both applications rely on the unique ability of Homology’s AAVHSCs to efficiently target multiple tissues in the body. Homology’s AAVHSCs were isolated from human stem cells, and Homology believes they can direct nuclease-free gene integration with higher efficiency relative to that indicated in published data for other AAV-based gene editing approaches. Homology’s AAVHSCs display the following advantages:

Single AAVHSC Platform for Both Gene Therapy and Gene Editing Modalities

Homology’s platform provides it the flexibility to deliver genetic medicines through the best suited modality from either gene therapy or gene editing for each disease it pursues, based on factors such as the targeted disease biology, the biodistribution of Homology’s AAVHSCs to key tissues, and the rate of cell division the tissues exhibit.

Ability to Perform In Vivo Nuclease-free Gene Editing Mediated by HR

To demonstrate the utility of AAVHSC-mediated gene editing in vivo, Homology conducted a series of initial experiments utilizing AAVHSC15.

Homology obtained initial preclinical proof-of-concept for in vivo editing efficiency and tissue-specific expression through the design of a promoter-less luciferase construct targeting the murine Factor 8, or F8, locus using AAVHSC15. F8 is a locus in the murine genome that is known to have a strong promoter but is expressed only in the liver.

 

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AAVHSC15 packaging the promoter-less F8 targeting cassette (AAVHSC15-mF8-Luc) was administered by a single intravenous injection to albino-B6 mice and high levels of luciferase expression in livers were observed. Bioluminescence increased within a week post-dosing, reached a maximum within 1-2 months and remained significantly above that observed in vehicle-treated mice until the end of the study at 470 days post-dosing (*= P<0.0001 vs vehicle). Ex vivo imaging of tissues harvested on Day 470 showed highest luciferase expression within liver (*=p<0.008 vs vehicle), greater than 100-fold higher than other tissues assessed (**=P<0.0001 vs other tissues), which demonstrated specificity of tissue targeting by AAVHSC15-mF8-Luc. At 470 days post-dosing, vector genome levels within livers of treated mice were on average 4.7 ± 2.7 vector genomes/allele.

To molecularly characterize AAVHSC15-mF8-Luc-mediated genome editing, a ddPCR-based quantitative F8 editing assay was established. A combination of an F8 locus-specific primer and probe and editing vector specific primer and probe in the FAM and HEX channel, respectively, were used to calculate the fraction of F8 loci that had an inserted luciferase transgene. Genomic DNA was isolated from livers of treated mice at termination of the study at 470 days post-dosing. Mice treated with AAVHSC15-mF8-Luc at this initial low dose of 5e12 vg/kg showed a statistically significant increase in genome editing efficiencies with up to 2.8% of alleles edited (mean 0.8% of alleles edited with a range of editing efficiencies 0.2-2.8%; p<0.03 vs. vehicle). These data demonstrate that AAVHSC15 mediated long-term in vivo editing of the targeted locus within the liver of mice at this dose.

To assess whether expression from AAVHSC15-mF8-Luc was episomal, an AAVHSC15-Luc editing vector was prepared with the splice acceptor sequences removed (designated AAVHSC15-Δ2AmF8-Luc) but maintained an intact Met initiator codon. Relative to an IV injection of vehicle alone, injection of AAVHSC15-mF8-Luc increased luciferase expression at Days 3, 7, and 14 post-dosing, similar to the results described above. By contrast, luciferase expression was reduced >95% for mice that received an identical dose of AAVHSC15-Δ2AmF8-Luc.

Ability to Introduce Entire Gene into the Genome Mediated via HR

This preliminary proof-of-principle described above provided data confirming the ability to edit the genome via nuclease free HR. Expanding on these initial data led to the discovery and development of a therapeutic program for PKU focused on the targeted integration of a full-length PAH cDNA into the human PAH locus.

Homology has successfully inserted full-length cDNA encoding PAH in vivo reaching levels of efficiency required for therapeutic efficacy. The preclinical data that supports HMI-103 is described in detail below in the Homology’s Former Product Candidates section.

The ability to introduce entire genes specifically into the genome at these efficiencies provides an opportunity to target multiple monogenic diseases where the correction of a defective gene would result in therapeutic benefit. Given that a majority of monogenic diseases harbor mutations that render the gene inactive, Homology believes its gene integration modality can be expanded well beyond its initial focus on liver-based inborn errors of metabolism.

High Precision and Lack of Unwanted Off-target or On-target DNA Modifications

Using next-generation sequencing technologies, Homology has developed methodologies to test for on-target mutations at the site of integration. Using these methods, Homology observed that HR using Homology’s AAVHSCs is very precise at the site of correction. Homology did not detect any co-incident random mutations at or above Homology’s lower limit of detection (0.5%) or inverted terminal repeat, or ITR, sequences at the site of integration.

Homology developed a method to enable whole genome unbiased next-generation sequencing for the detection and mapping of off-target integration sites. By leveraging the potential ability of Homology’s AAVHSCs to drive HR-based targeted integration, Homology can utilize next-generation sequencing technologies to identify and quantify where the inserted sequence maps. Using this method, and testing integration into the human AAVS1 locus, Homology estimates that 99.967% of insertions (>2.2 million reads)

 

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are at the targeted site and that the balance is within expected background of the assay. Homology has expanded on this assay to characterize the on-target precision of integration at the PAH locus in support of HMI-103. In a humanized in vivo liver model, HMI-103 showed precise on-target integration and no off-target edits. These data were peer-reviewed and published in PLOS ONE in 2020 and are described below.

Ability to Target Multiple Tissues

In preclinical studies, intravenous administration of Homology’s family of AAVHSCs has demonstrated the ability to target a wide variety of tissues including the liver, CNS, PNS, muscle, bone marrow, eye and heart (refer to Figure 4 below). Specifically, Homology has generated evidence of its AAVHSCs’ ability to target a number of tissues including:

 

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neurons throughout the brain, spinal cord, and dorsal root ganglion by crossing the blood-brain-barrier and the blood-nerve-barrier;

 

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retinal ganglion cells and neurons of the retinal outer nuclear layer; Homology has also demonstrated the ability to target retinal tissue via intravenous injection as well as multiple layers of target cells, including photoreceptors, retinal pigment epithelial cells and horizontal cells, through sub-retinal injection;

 

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skeletal muscle myocytes in all skeletal muscle tissues examined, including gastrocnemius, soleus, diaphragm, esophagus, and biceps;

 

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cardiomyocytes throughout the heart; and

 

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extensive liver tropism.

Homology generated preclinical data showing that AAVHSC16, one of the capsids in its family of 15 naturally occurring AAVHSCs, demonstrated low levels of tropism to the liver and no elevations in liver enzymes while maintaining robust distribution to the CNS and peripheral organs following a single I.V. administration (refer to Figure 5 below). Homology believes the unique properties of AAVHSC16 make it an attractive capsid for development in new disease indications with Homology’s genetic medicines platform. The data were peer-reviewed and published in the journal Molecular Therapy—Methods & Clinical Development.

 

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Figure 4. Homology’s family of AAVHSCs has demonstrated the ability to target a wide variety of tissues.

 

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Figure 5. AAVHSC16 has reduced in vivo liver tropism in NHPs while exhibiting robust distribution to other peripheral organs and the CNS.

In vivo Administration with a Single Component Delivery System

Homology’s platform is designed to perform gene integration at higher efficiency without the use of a nuclease, enabling it to deliver genetic medicines in vivo using a single vector system (refer to Figure 6 below). Existing nuclease-based gene editing technologies, when replacing a defective gene with a functional gene through gene editing, require the use of two or more different vector constructs in combination to perform their gene editing functions. One or more vector constructs house the nuclease, and the other vector construct houses the DNA template, and all vectors must reach and penetrate the specific target cell at the same time to edit the DNA. In contrast to these nuclease-based gene editing technologies, Homology’s AAVHSC technology is a single component system that contains everything required to selectively integrate DNA with no need for additional exogenous nucleases, template DNA or editing machinery.

Homology believes its ability to perform gene integration at efficiencies that are greater than both nuclease-based and other AAV-based approaches, coupled with its single component delivery system, enable it to administer genetic medicines in vivo. Homology believes the advantages of in vivo administration of therapeutics via a single component delivery system include the following:

 

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simpler and faster manufacturing relative to ex vivo therapeutic approaches resulting in reduced manufacturing costs;

 

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improved delivery of therapeutics as only a single vector is required to reach a cell instead of multiple vectors;

 

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ease of use for the patient, eliminating the need for mobilization and myeloablation, a common requirement for many ex vivo gene editing therapies; and

 

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improved safety profile, as compared to an ex vivo therapy.

 

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Figure 6. Homology’s nuclease-free AAVHSC single-component gene editing construct vs. nuclease-based multiple-component gene editing construct for gene editing applications.

Ability to Target a Broad Range of Patients Given Low Frequency of Pre-Existing Neutralizing Antibodies

A potential concern for all AAV vectors is the presence of pre-existing neutralizing antibodies that have the potential to reduce their effectiveness. Homology conducted a study across 100 human serum donors representing different ethnic segments of the U.S. population. Based on the initial results, Homology believes the findings suggest that approximately 80% of individuals lack antibodies that recognize AAVHSCs, which is comparable to AAV9, a commonly used vector for development of other gene therapies. These findings were published in Human Gene Therapy Clinical Development in March 2018.

 

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Homology’s Former Product Candidates

HMI-103 Gene Editing Candidate for the Treatment of Adult Patients with PKU

Homology’s lead gene editing program, HMI-103, was a one-time, in vivo, nuclease-free gene editing candidate for the treatment of classical PKU. HMI-103 was designed to harness the body’s natural DNA repair process of homologous recombination to replace the disease-causing gene with a functional gene and liver-specific promoter and to maximize PAH expression in all transduced liver cells through episomal expression.

PKU Disease Overview

PKU is an inborn error of metabolism that results from mutations in the PAH gene. PAH is an enzyme that is normally expressed in the liver and is necessary to metabolize dietary phenylalanine, or Phe, to the amino acid tyrosine, or Tyr. Tyr is a product of Phe metabolism and a precursor to neurotransmitters, and its increase indicates increased enzymatic activity. PKU results from mutations in PAH that render its enzymatic activity deficient. If it is not metabolized by PAH, Phe builds up throughout the body, including in the blood and the nervous system. Approximately 75% of all dietary Phe is typically metabolized by PAH, so the absence of PAH leads directly to the pathological excess of Phe as well as a deficiency of Tyr. Excessive blood Phe and low levels of Tyr result in intellectual disability, which is possibly caused by a variety of mechanisms including effects on neuronal development, myelination, and neurotransmitter synthesis. Blood Phe is an easily measurable and translatable biomarker. It is also a validated clinical endpoint in clinical trials for PKU, facilitating both a rapid path to the clinic and characterization of therapeutic response.

Newborns in all 50 states are screened for PKU. It has been estimated that the incidence of PKU in the United States is one in 12,707, which translates to approximately 350 cases per year with an overall prevalence of 16,500. It has also been estimated that the prevalence of PKU in the European Union is 25,000. Worldwide, the estimated prevalence is 50,000 with 1,000 to 1,500 new cases annually.

The majority of patients are identified soon after birth and are primarily treated by dietary restriction of Phe. While Phe-restricted diets have dramatically reduced the intellectual deficiencies associated with this disease, they fail to address the cognitive and behavioral problems that continue throughout a patient’s life. Lifetime adherence to a Phe-restricted diet is challenging and blood Phe within the recommended range is not achievable for the vast majority of patients. The inability to achieve recommended levels of Phe results in neurological as well as metabolic problems. Long-term studies in adults identify neurocognitive, psychosocial, quality of life, growth, nutrition, bone pathology and maternal PKU outcomes that are suboptimal despite early and continuous treatment with diet. In a retrospective study of PKU patients, peer-reviewed and published in the journal of Molecular Genetics & Metabolism, young children were adherent to Phe-restricted diet, whereas most adolescents (79%) did not achieve recommended Phe levels, and 88% of adults were no longer on a Phe-restricted diet. Relaxing of dietary restrictions beyond preschool years, or failure to adhere to physician-assigned diets, which is the current guideline for most adolescents and adults, results in loss of metabolic control and wide fluctuations in Phe levels that are both directly associated with progressive neurological damage.

 

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Homology conducted a five-year retrospective chart review of PKU patients, which confirmed key elements of Homology’s PKU programs. Consistent findings from two PKU academic centers of excellence in the U.S. in 152 PKU patients showed that actively monitored patients, including those on restrictive low Phe diet, had Phe levels well-above the recommended threshold of 360 umol/L, based on current U.S. treatment guidelines, underscoring the need for treatments that restore the normal biochemical pathway (refer to Figure 7 below). Furthermore, Homology confirmed that Phe continues to be higher, even on standard of care, in the classical PKU population, defined as patients with Phe levels greater than 1200 umol/L (66% of the study population) without treatment, and was significantly elevated in the adult population compared to those patients who were less than 18 years of age. These findings were published in Molecular Genetics and Metabolism in December 2019.

 

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Figure 7. Retrospective five-year chart review demonstrates actively monitored adult classical PKU patients across two academic centers have Phe levels >700 umol/L.

Current Treatments

There are currently no available treatments that address the core underlying genetic biochemical defect in PKU, the deficiency of PAH.

Saproterin dihydrochloride, or Kuvan(R), is an FDA-approved therapy to reduce elevations in serum Phe. Kuvan is a synthetic version of BH4, a cofactor that is required for PAH activity. Treatment with BH4 can activate residual PAH enzyme activity, improve the normal oxidative metabolism of Phe, and decrease Phe levels in some patients; however, clinical data suggests that Kuvan is not fully effective in lowering high serum levels of Phe back to normal levels and must be used in conjunction with a low Phe diet. While this approach can increase residual PAH activity, it does not fully correct the underlying genetic disorder (PAH deficiency). Worldwide sales of Kuvan were approximately $228 million in 2022. Generic versions of Kuvan are available in several countries around the world, including multiple generic versions in the U.S.

Pegvaliase, or Palynziq(R), is a pegylated plant-derived enzyme called phenylalanine ammonia lyase that was approved in the U.S. by the FDA in 2018 and in Europe by the EC in 2019. Similar to Kuvan, this approach does not correct the underlying genetic disorder (PAH deficiency) and will not reconstitute the natural pathway. Homology believes Palynziq to have certain limitations including that it must be administered via daily injections and its label contains a black box warning that it can cause severe allergic reaction (anaphylaxis) that may be life-threatening and can happen at any time during treatment with Palynziq. The label states that patients must carry auto-injectable epinephrine with them at all times during Palynziq treatment. Patients in its Phase 3 trials did not meet the secondary efficacy endpoints for cognitive benefit. Worldwide sales of Palynziq were approximately $255 million in 2022.

 

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Homology’s Gene Editing Approach to PKU

The goal of Homology’s gene integration approach is to enable production of functional PAH, thus restoring the normal biochemical pathway of Phe metabolism. This can reduce the abnormally high levels of Phe in the blood, while also increasing Tyr levels, the product of PAH-driven Phe metabolism. Homology believes the gene integration approach would be optimal for newborn and pediatric patients due to the higher rate of dividing cells as the child grows. Using gene editing to correct the defective PAH gene in young patients has the potential to provide long-term benefit as the corrected gene will persist as cells replicate. Correcting the gene has the potential to normalize not only Phe levels, but also Tyr levels, the product of the Phe metabolism and a precursor to neurotransmitter synthesis. This may allow affected children to avoid many of the serious neurological consequences associated with PKU.

Homology believes that an effective gene editing treatment for PKU has the potential to eliminate the need for Phe-restricted diet and may lead to significant improvements in the morbidity and quality of life for patients. Published estimates suggest that restoration of PAH activity to 10% or more of normal levels would lead to significant improvements in serum Phe levels and potentially represent a curative therapy.

The gene editing vector transgene is flanked by left and right homology arms, containing sequences that are identical and specific to the genomic target. The arms were designed to integrate by non-nuclease-based, AAV-mediated HR into the target human PAH locus. This therapy aims to correct the genetic defect within the treated liver cells then directing the expression of the PAH protein. HR-based integration via AAVHSCs is highly precise, without the introduction of insertions, deletions or viral ITRs. The corrected copy of the PAH gene would be retained as cells divide into daughter cells as the liver grows. Screening for PKU of all newborns in the United States allows for the identification of affected individuals before serious neurological complications develop. Homology believes its HR approach possesses the efficacy and durability characteristics that would be appropriate to treat PKU in newly identified patients.

 

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Preclinical Studies with HMI-103

Homology has conducted in vivo experiments showing the integration of a human PAH cDNA into the human PAH gene locus using a humanized liver mouse model. In this model, human hepatocytes constitute the majority of the liver cells, providing an in vivo model to test human-specific editing constructs. Injection of the HMI-103 gene editing candidate in this model resulted in the insertion of a codon-optimized human PAH cDNA into the human PAH locus and mRNA expression of the PAH cDNA. The in vivo integration rate at the target locus, shown in Figure 8, was calculated at a frequency of 6%. This level of editing has been shown to be sufficient to normalize Phe levels in the murine model. A second assay was also performed on DNA that was specific for human and murine hepatocytes obtained from this study. The assay provides an orthogonal approach for characterizing the frequency of targeted integration and enables testing the species-selectivity of the targeted integration. The results of this assay showed integration only in the human hepatocytes and not in the murine hepatocytes, demonstrating selectivity for the human locus. Figure 9 below shows data following I.V. administration of the murine surrogate, or the murine version of HMI-103. The human construct is designed with human-specific homology arms, so a murine surrogate is necessary for testing in the PKU murine model. As depicted, Homology observed that PAH gene integration was durable out to 43 weeks (end of study) and resulted in marked and durable serum Phe reduction.

 

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Figure 8. Human-specific AAVHSC PAH gene editing candidate resulted in a targeted integration rate of 6%, as measured by NGS in an in vivo humanized liver murine model.

 

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Figure 9. I.V. administration of murine surrogate (with murine homology arms) of HMI-103 showed durable gene integration in the Pahenu2 model of PKU.

The fidelity of the integration of the cDNA into the target locus was evaluated by NGS sequencing. There were no de novo mutations detected in either homology arm target site. Homology also evaluated the samples for the presence of ITRs. Viral ITRs are non-homologous sequences that lie beyond the extent of the recombination event and thus should not be integrated into the target site. The integrated alleles were free of ITR sequence, consistent with HR as the main mechanism for integration. Together, these data showed that the targeted integration of the human PAH cDNA into the human PAH locus displayed sequence fidelity with no evidence of mutations. A genome-wide integration assay using long-read NGS was developed to assess for off-target HR-mediated integration in human hepatocytes. No off-target HR-mediated integration sites were detected above the limit of detection.

The potency of HMI-103 was compared to non-integrating gene therapy vector HMI-102. In a dose-range finding study, the murine surrogate of HMI-103 and gene therapy vector HMI-102 were administered via one-time I.V. infusions to the Pahenu2 model, and the murine surrogate of HMI-103 was ten times more potent than HMI-102, which was consistent across all time points tested.

 

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Figure 10. HMI-103 was ten times more potent than non-integrating gene therapy construct HMI-102 in the Pahenu2 model of PKU. The analysis compared the dose at which fifty percent Phe reduction was achieved in the model.

In 2023, Homology presented preclinical data at WORLDSymposium™, which supported the immunosuppression regimen that was incorporated in its former clinical trials. In NHPs, Homology’s data

 

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demonstrated that modulating T-cell activity using tacrolimus together with dexamethasone was important in reducing B-and T-cell activity, neutralizing antibody, or nAb, formation, and maintaining transgene expression following rAAV administration in NHPs.

pheEDIT Phase 1 Clinical Trial with HMI-103

In September 2023, Homology inactivated its pheEDIT Phase 1 gene editing clinical trial evaluating HMI-103 in adults with classical PKU (NCT05222178).

The pheEDIT clinical trial was an open-label, dose-escalation study evaluating the safety and efficacy of a single I.V. administration of HMI-103 in patients ages 18-55 years old who were diagnosed with classical PKU due to phenylalanine hydroxylase, or PAH, deficiency. In addition to safety endpoints, the trial measured serum Phe changes. The trial incorporated an immunosuppressive regimen that included a T-cell inhibitor used in combination with a steroid-sparing regimen. Patients were dosed following requisite Institutional Biosafety Committee and Institutional Review Board approvals at the clinical sites, and completion of an 82-day screening/run-in period to account for and more closely understand day-to-day Phe fluctuations of participants.

In October 2023, Homology reported clinical data from the first dose cohort in the pheEDIT trial. As of the data cut-off date of September 14, 2023, HMI-103 was generally well-tolerated in all three participants with no serious adverse events, and the majority of treatment-related adverse events were mild and transient. All liver function tests remained in the normal range during the prophylactic immunosuppression regimen incorporating the T-cell inhibitor tacrolimus in combination with corticosteroid. Participant 1 experienced a reduction in plasma phenylalanine, or Phe, levels to below the U.S. American College of Medical Genetics and Genomics PKU treatment guideline threshold of <360 µmol/L, and the majority of Phe levels were below 360 µmol/L through 39 weeks post-dose, including after the initiation of dietary protein supplementation. Participant 2 experienced a meaningful plasma Phe reduction of 50% at 23 weeks post-dose. Participant 3 experienced a meaningful plasma Phe reduction of 60% at 14 weeks post-dose.

HMI-102 Investigational Gene Therapy for the Treatment of Adult Patients with PKU

HMI-102 was an AAVHSC vector gene therapy candidate designed to treat PAH deficiency, the underlying genetic cause of PKU. HMI-102 consisted of an AAVHSC15 vector containing the coding sequence of human PAH under control of a promoter designed to continuously express PAH, specifically in the liver. Homology chose AAVHSC15 as the basis of this product candidate because of its tropism for the liver, the normal site for PAH protein expression.

pheNIX Phase 1/2 Clinical Trial with HMI-102

In August 2023, Homology terminated its pheNIX Phase 1/2 gene therapy clinical trial evaluating HMI-102 in adults with classical PKU. In September 2023, Homology withdrew its IND for the pheNIX Phase 1/2 clinical trial.

The pheNIX clinical trial was designed to evaluate the safety and efficacy of the investigational gene therapy in a randomized, concurrently controlled, dose-escalation study in adult patients aged 18–55 years old with classical PKU. The dose-escalation phase of the trial was designed to evaluate safety and efficacy of ascending doses of HMI-102 to enable the selection of a dose for the randomized, concurrently controlled Phase 2 portion of the trial. Homology enrolled six patients in the dose-escalation phase across three dose cohorts.

In November 2020, Homology reported positive clinical data from the dose-escalation phase of the trial. Safety data from the six patients as of the cutoff date of October 19, 2020, showed HMI-102 was generally well-tolerated, and there were no treatment-related serious adverse events. There were no clinically significant

 

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changes in electrocardiogram or vital signs, no clinical signs of complement activation and no adverse events related to bilirubin. Alanine aminotransferase, or ALT, elevations, which are common in AAV-based gene therapy trials, were asymptomatic and managed with increased steroids when necessary and all ALT elevations were resolved. Efficacy data showed significant plasma Phe reductions in Cohorts 2 and 3, compared to Cohort 1 (P<0.004 post-hoc comparison using repeated measures MANOVA, or multivariate analysis of variance regression analysis), with two patients achieving target Phe levels per treatment guidelines, even while self-liberalizing diet. Compared to baseline, patients in Cohorts 2 and 3 also displayed Tyr increases and Phe-to-Tyr ratio decreases consistent with PAH enzymatic activity.

Based on the safety and efficacy results observed in the dose-escalation phase as of the cutoff date, in early 2021, Homology advanced to the Phase 2 randomized, concurrently controlled, expansion phase of the pheNIX trial. Homology selected two doses for the expansion phase: 6E13 vg/kg and 8E13 vg/kg. In October 2021, Homology announced that as of September 30, 2021, both doses in the expansion phase of the trial were generally well-tolerated and showed evidence of biological activity, including clinically meaningful reductions in Phe levels, increases in Tyr and reductions in the Phe-to-Tyr ratio.

On February 18, 2022, Homology announced that its pheNIX gene therapy trial was placed on clinical hold due to the need to modify risk-mitigation measures in the study in response to observations of elevated liver function tests, or LFTs. On March 17, 2022, Homology received the official clinical hold letter from the FDA requesting information on elevated LFTs observed in some patients in the trial and modified clinical risk-mitigation measures. In patients who experienced elevated LFTs, all have resolved and no hospitalizations were required. Homology responded to the FDA regarding the clinical hold, and included in its response was a protocol amendment designed to address the FDA’s requests and reduce the risk of observing further elevated LFTs in the trial, including among other things, a new, more targeted immunosuppressive regimen that utilized a T-cell inhibitor and a shorter duration and earlier tapering of steroids. The use of T-cell inhibitors has been shown to be effective in dampening the anticipated immune response to AAV capsids in the clinical setting. This proposed immunosuppressive regimen was incorporated into Homology’s pheEDIT clinical trial for the treatment of patients with PKU. On June 13, 2022, Homology announced that the FDA lifted the clinical hold, with the FDA noting in its response that Homology satisfactorily addressed all clinical hold issues identified in the March 17, 2022 letter.

On August 15, 2022, Homology paused the enrollment of its Phase 1/2 pheNIX clinical trial with HMI-102, in order to focus resources and efforts on its Phase 1 pheEDIT clinical trial evaluating in vivo gene editing candidate HMI-103 for PKU. In August 2023, Homology terminated its pheNIX Phase 1/2 gene therapy clinical trial evaluating HMI-102 in adults with classical PKU and in September 2023, Homology withdrew its IND for the pheNIX clinical trial.

HMI-203 Investigational Gene Therapy for the Treatment of Adult Patients with MPS II (Hunter Syndrome)

HMI-203 was a one-time gene therapy candidate for the treatment of patients with Hunter syndrome. HMI-203 was designed to use one of Homology’s AAVHSC vectors to deliver functional copies of the IDS gene to multiple target organs, including the PNS and CNS, following a single I.V. administration, where there are missing or mutated copies of the gene.

Hunter Syndrome Disease Overview

Hunter syndrome is a rare, X-linked lysosomal storage disorder caused by mutations in the iduronate-2-sulfatase, or IDS, gene, which is responsible for producing the I2S enzyme that breaks down large sugar molecules, or cellular waste, called glycosaminoglycans, or GAGs. Severe Hunter syndrome results in toxic lysosomal accumulation of GAGs that causes progressive debilitation and decline in intellectual function. Hunter syndrome occurs in approximately 1 in 100,000 to 1 in 170,000 males, and the severe form leads to life expectancy of 10 to 20 years. In August 2022, the Department of Health and Human Services approved the addition of MPS II as a condition to the recommended uniform screening panel for newborns.

 

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Current Treatments

The standard of care for treating Hunter syndrome is enzyme replacement therapy, or ERT, which can delay some complications but does not treat CNS manifestations of Hunter syndrome given that the enzyme cannot cross the blood-brain-barrier. In 2006, the recombinant form of human I2S (Elaprase), an ERT for the treatment of Hunter syndrome was approved by the FDA and subsequently approved for use internationally. In January 2021, the recombinant form of idursulfase-beta (Hunterase), an ERT for the treatment of Hunter syndrome received manufacturing and marketing approval in Japan and in March 2021, pabinafusp alfa, a recombinant iduronate-2-sulfatase ERT that delivers therapeutics across the blood-brain barrier was approved by the Ministry of Health, Labour and Welfare in Japan and has been marketed since May 2021 under the brand name “IZCARGO® I.V. Infusion 10mg.” However, specific treatment to address the neurological manifestations of Hunter syndrome and prevent or stabilize cognitive decline remains a significant unmet medical need outside of Japan.

Preclinical Studies with HMI-203

In preclinical studies, a single I.V. administration of HMI-203 led to robust biodistribution and sustained human I2S (hI2S) enzyme expression, which resulted in significant reductions in key Hunter syndrome biomarkers of heparan sulfate GAGs and lysosomal-associated membrane protein 1 (LAMP-1) in the brain, liver, heart, spleen, lungs and kidneys compared with the vehicle. Significant reductions in heparan sulfate GAGs in the cerebrospinal fluid (CSF) compared with vehicle were also observed, as well as ameliorated paw deformities, as shown by significant changes in measurements of ankle depth, paw width, paw depth and ankle width compared with vehicle. Finally, HMI-203 administration led to uptake of hI2S from the serum of the HMI-203-treated model in human cell lines, which demonstrated the potential for cell cross-correction. These data were presented at WORLDSymposium™ in 2021 and 2022 (refer to Figure 11 below).

 

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Figure 11. Single IV administration of HMI-203 demonstrated systemic expression, reduction of GAGs, and correction of phenotype in murine model.

juMPStart Phase 1 Clinical Trial with HMI-203

In August 2023, Homology terminated its juMPStart Phase 1 gene therapy clinical trial evaluating HMI-203 in adults with Hunter Syndrome and in December 2023, withdrew its IND for the juMPStart clinical trial.

 

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The juMPStart clinical trial was an open-label, dose-escalation study evaluating the safety and efficacy of a single I.V. administration of HMI-203, expected to enroll up to nine male patients in up to three dose cohorts, ages 18-45 years old, who had been diagnosed with Hunter syndrome and were receiving enzyme replacement therapy. In addition to safety endpoints, the trial was designed to measure plasma I2S activity, urinary GAG levels and other peripheral disease manifestations. Qualitative data on unmet medical needs from ERT-treated adult MPS II patients and/or their caregivers helped inform Homology’s trial design. Patients and caregivers reported that weekly ERT infusions, surgeries and supportive therapies inadequately address range of motion and mobility, pain, and hearing loss, that there are burdens associated with ERT and other therapies, including frequency and duration of treatment, and painful and extended recoveries, that there is a high degree of anxiety regarding prognosis, longevity, need for more invasive surgeries, and financial challenges and that the expectations for a potential one-time gene therapy include the ability to maintain their current quality of life with ERT independence. Also, key opinion leaders surveyed supported Homology’s planned design for the juMPStart clinical trial, including Homology’s plan to discontinue ERT.

HMI-204 for Treatment of Adult Patients with MLD

Homology completed IND-enabling studies with HMI-202, an investigational gene therapy for the treatment of patients with MLD. Applying the learnings from these IND-enabling studies, in August 2022, Homology announced the details of HMI-204, an optimized, in vivo, one-time gene therapy product candidate for the treatment of MLD. Homology is no longer developing HMI-204.

MLD is a lysosomal storage disease caused by mutation of a gene called arylsulfatase A, or ARSA. The protein ARSA is required for the breakdown of cellular metabolic products that in MLD accumulate in all cells of the body. Cells responsible for the production of myelin are especially sensitive to the toxic build-up of these cellular metabolic products, leading to progressive serious neurological deterioration. The late infantile form of MLD, which is the most common form, includes rapidly progressive motor and cognitive decline and loss of vision. The majority of these patients do not survive past the first decade of life.

In Europe, Libmeldy (autologous CD34+ cells encoding the ARSA gene), a lentiviral vector-based gene therapy for the treatment of MLD, became the first therapy approved for eligible patients with early-onset MLD in December 2020 following receipt of full (standard) market authorization by the EC. This treatment is not currently approved in the United States. While efficacious in late infantile and early juvenile children (with no or very early onset of symptoms), it has significant drawbacks, including myeloablation, the use of immunosuppression therapy, delayed onset of ARSA expression post-engraftment, conditioning regimens, and the risk of death from stem cell transplantation.

 

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At WORLDSymposium™ in 2023, Homology reported the outcome of the optimization of HMI-202 resulting in the nomination of HMI-204. The design optimization focused on achieving near-normal (or higher) ARSA expression in all disease-relevant tissues, in addition to overall manufacturing improvements. HMI-204 is a single-stranded codon-optimized ARSA sequence driven by a ubiquitous promoter (AAVHSCcoARSA). Following a single intravenous administration, HMI-204 resulted in broad and targeted systemic biodistribution and robust expression in the central nervous system, consistent with Homology’s previously reported crossing of the blood-brain barrier in the Arsa knockout murine model of MLD.

 

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Figure 12. Single administration of HMI-204 crossed the blood-brain barrier and resulted in a dose-response in ARSA activity in the brain of Arsa KO mice, as assessed 12 weeks post dosing. HMI-204 achieved levels of ARSA expression (doses X, Y and Z) predicted to lead to a direct motor benefit in the rotarod assay, as previously demonstrated with HMI-202.

 

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In the brain of HMI-204-treated adult Arsa knockout mice, ARSA cellular expression patterns were nearly identical to that of murine Arsa distribution in wildtype age-matched littermates, as previously demonstrated with HMI-202. Moreover, the optimized HMI-204 construct showed lowered expression in the heart (as compared with HMI-202), while maintaining strong liver expression, as demonstrated by anti-ARSA immunohistochemistry (refer to Figure 13 below). Lastly, an overall improvement in HMI-204 productivity was achieved (refer to Figure 14 below).

 

LOGO

Figure 13. In Arsa KO mice, HMI-204 maintained a robust and broad distribution of ARSA across the entire axis of the brain and liver while lowering its expression in heart tissue, as compared with the anti-ARSA biodistribution achieved with HMI-202.

 

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Figure 14. Outcome of HMI-204 packaging productivity achieved leading to an ~120% improvement in vector genome yields compared with historical HMI-202 data.

 

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HMI-104 for the Treatment of Adult Patients with PNH

In August 2021, Homology named a clinical development candidate for PNH, HMI-104, from Homology’s GTx-mAb platform. Homology is no longer developing HMI-104.

PNH is a rare, acquired, life-threatening blood disease caused by mutations in the PIGA gene that result in intravascular hemolysis, or red blood cell destruction, mediated by uncontrolled activation of the complement system. PNH results in thromboses, recurrent pain, severe anemia, kidney disease and impaired quality of life, among other outcomes.

Homology’s GTx-mAb platform represents an additional way that Homology could potentially leverage its AAVHSCs to deliver one-time in vivo gene therapy to express and secrete antibodies from the liver, which Homology believes may allow it to target diseases with larger patient populations. In support of this program, Homology generated and presented preclinical data targeting complement protein 5, demonstrating preclinical proof-of-concept in PNH. A single I.V. dose of an AAVHSC GTx-mAb showed expression of full-length antibodies from the liver consistent with anti-C5 therapeutics levels, sustained and robust Immunoglobulin G, or IgG, expression in vivo in a humanized murine liver model and a murine NOD-SCID model, and in vivo vector-expressed C5 mAb had potent functional activity as shown by an ex vivo hemolysis assay. Additionally, Homology observed sustained expression of C5 mAb in the presence of murine and human FcRn. Homology completed IND-enabling studies with HMI-104.

 

 

LOGO

Figure 15. Preclinical C5 Data Demonstrated Potential when Administered as a Sustained, Low Dose, One-Time Treatment.

Manufacturing

In 2022, Homology established OXB Solutions, an AAV manufacturing and innovation business which incorporated Homology’s process development and manufacturing platform and process that supports both gene therapy, gene editing and Homology’s GTx-mAb platform, and is scalable from preclinical to GMP. Homology’s process development and manufacturing strategy leveraged a single platform for gene therapy, gene editing and Homology’s GTx-mAb platform that is scalable and facilitates rapid development to the clinic. Homology leveraged its manufacturing platform across its entire pipeline, from its research programs to its preclinical and

 

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clinical programs. Homology’s platform was designed from its inception to be its commercial process, allowing it to rapidly transition from research into the clinic and eventually to commercialization. Prior to the transaction with Oxford, Homology’s manufacturing platform was scaled and tested across more than 450 different constructs with more than 550 unique lots of vector successfully executed. OXB Solutions announced that its platform has produced high-quality titers of E15 vg/L and achieved over 90% fully intact vector. Homology’s manufacturing platform has been scaled to 2000L in non-GMP and 500L in GMP.

Homology’s manufacturing strategy utilized mammalian cells for its AAVHSC vector-based product candidates. All of Homology’s former programs utilized HEK293 transfection in a serum-free suspension bioreactor process. HEK293 is a well-characterized and commonly used system for many clinical-stage AAV vector products. Additionally, HEK293 cells are familiar to regulatory authorities, and commercial raw materials and reagents are readily available. Homology’s purification leveraged chromatography-based operations to provide high quality vector and ensure robust commercial-scale operations. In addition to its process development, Homology also internally developed 45 analytical methods to test, monitor, and characterize its products.

Oxford Biomedica Solutions Transaction

On March 10, 2022, Homology closed a transaction with OXB Solutions, OXB, and OXB Parent pursuant to the Purchase Agreement, dated as of January 28, 2022, by and among Homology, OXB Solutions and Oxford, whereby, among other things, Homology and Oxford agreed to collaborate to operate OXB Solutions, which provides AAV vector process development and manufacturing services to biotechnology companies, which Homology refers to as the Oxford Biomedica Solutions Transaction, or the OXB Solutions Transaction. OXB Solutions incorporates Homology’s proven ‘plug and play’ process development and manufacturing platform, as well as Homology’s experienced team and high-quality GMP vector production capabilities that Homology built and operated since 2019.

Pursuant to the terms of the Purchase Agreement and a contribution agreement, or the Contribution Agreement, entered into between Homology and OXB Solutions prior to the closing of the OXB Solutions Transaction, or the Closing, Homology agreed to assign and transfer to OXB Solutions all of Homology’s assets that are primarily used in the manufacturing of AAV vectors for use in gene therapy or gene editing products, but excluding certain assets related to manufacturing or testing of Homology’s proprietary AAV vectors, or collectively, the Transferred Assets, in exchange for 175,000 common equity units in OXB Solutions, or Units, and OXB Solutions assumed from Homology, and agreed to pay, perform and discharge when due, all of Homology’s duties, obligations, liabilities, interests and commitments of any kind under, arising out of or relating to the Transferred Assets.

Effective as of the Closing, Homology sold to OXB, and OXB purchased from Homology, 130,000 Units, or the Transferred Units, in exchange for $130.0 million. In connection with the Closing, OXB contributed $50.0 million in cash to OXB Solutions in exchange for an additional 50,000 Units. Immediately following the Closing, (i) OXB owned 180,000 Units, representing 80 percent (80%) of the fully diluted equity interests in OXB Solutions, and (ii) Homology owned 45,000 Units, representing 20 percent (20%) of the fully diluted equity interests in OXB Solutions.

Pursuant to the Amended and Restated Limited Liability Company Agreement of OXB Solutions, or the OXB Solutions Operating Agreement, which was executed in connection with the Closing, at any time following the three-year anniversary of the Closing, (i) OXB will have an option to cause Homology to sell and transfer to OXB, and (ii) Homology will have an option to cause OXB to purchase from Homology, in each case all of Homology’s equity ownership interest in OXB Solutions at a price equal to 5.5 times the revenue for the immediately preceding 12-month period, subject to a specified maximum amount. Pursuant to the terms of the OXB Solutions Operating Agreement, Homology is entitled to designate one director on the board of directors of OXB Solutions, currently Paul Alloway, Ph.D., Homology’s President and Chief Operating Officer.

 

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Concurrently with the Closing, Homology entered into certain ancillary agreements with OXB Solutions including a license and patent management agreement whereby OXB Solutions granted certain licenses to Homology, a supply agreement for a term of three years which includes certain annual minimum purchase commitments, a lease assignment pursuant to which Homology assigned all of its right, title and interest in, to and under Homology’s facility lease to OXB Solutions, a sublease agreement whereby OXB Solutions subleased certain premises in its facility to Homology, as well as several additional ancillary agreements.

Competition

The biotechnology and pharmaceutical industries, including in the gene therapy and gene editing fields, are characterized by rapidly advancing technologies, intense competition and a strong emphasis on intellectual property and proprietary products. While Homology believes that its technology, development experience and scientific knowledge provide it with competitive advantages, Homology has requested withdrawal or discontinuation of each of its previously open INDs. Should Homology resume development of its product candidates, Homology will face potential competition from many different sources, including major pharmaceutical, specialty pharmaceutical and biotechnology companies, academic institutions and governmental agencies, and public and private research institutions that conduct research, seek patent protection, and establish collaborative arrangements for research, development, manufacturing, and commercialization. Not only would Homology compete with other companies that are focused on gene therapy and/or gene editing technologies, any product candidates that Homology successfully develops and commercializes would compete with existing therapies and new therapies that may become available in the future.

Homology competes in the segments of the pharmaceutical, biotechnology and other related markets that utilize technologies encompassing genomic medicines to create therapies, including gene therapy and gene editing. There are additional companies that are working to develop therapies in areas related to Homology’s research programs.

Homology’s platform and product focus was the development of genetic medicines using its proprietary AAVHSCs in vivo through a nuclease-free gene editing modality, gene therapy, or GTx-mAb, which is designed to produce antibodies throughout the body. If Homology were to resume development of one or more of its product candidates and any of those product candidates were approved for the indications for which Homology’s clinical trials were originally designed, they may compete with other products currently under development, including gene therapy and gene editing products or other types of therapies, such as small molecule, antibody or protein therapies. If Homology were to resume development of its PKU HMI-103 product candidate and it were to be approved, it may compete with therapies from American Gene Technologies, BioMarin, Generation Bio, Moderna, Nestlé Health Science, PTC Therapeutics, Jnana Therapeutics, Poseida Therapeutics and Synlogic. However, Homology believes that only gene therapy or gene editing approaches have the potential to restore the normal Phe biochemical pathway with a single administration.

There are a number of companies developing nuclease-based gene editing technologies using CRISPR/Cas9, TALENs, meganucleases, Mega-TALs and ZFNs, including Beam Therapeutics, bluebird bio, Caribou Biosciences, Cellectis, CRISPR Therapeutics, Editas Medicine, Intellia Therapeutics, Precision BioSciences and Sangamo Therapeutics and non-nuclease-based technology, including LogicBio Therapeutics.

If Homology were to resume development of its Hunter syndrome HMI-203 product candidate and it were to be approved, it may compete with approved products, such as IZCARGO(R), a blood-brain-barrier-penetrating recombinant iduronate-2-sulfatase approved in Japan, Elaprase®, an enzyme replacement therapy, or ERT, from Takeda, and Hunterase ICV Injection, an ERT from GC Pharma, as well as investigational product candidates from Avrobio, Denali Therapeutics and REGENXBIO. However, Homology believes that only an I.V. gene therapy approach with the ability to cross the blood-brain-barrier has the potential to treat the peripheral and neurological manifestations.

If Homology were to resume development of its MLD HMI-204 product candidate and it were to be approved, it may compete with approved products, such as Libmeldy, a lentiviral vector-based ex vivo gene

 

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therapy from Orchard Therapeutics, which is approved in the EU and a select group of additional countries for the treatment of MLD in pre-symptomatic and early symptomatic patients, as well as investigational product candidates from Takeda and Passage Bio. Homology believes that its optimized in vivo gene therapy approach for MLD could be used early in the disease progression with the potential for earlier protein expression, potentially offering advantages over Orchard Therapeutics’ ex vivo approach, as well as advantages over chronic, intrathecal ERTs, such as Takeda’s approach.

In addition, many of Homology’s current or potential competitors, either alone or with their collaboration partners, have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials and marketing approved products. Homology has paused development of each of its product candidates. Mergers and acquisitions in the pharmaceutical, biotechnology and gene therapy industries may result in even more resources being concentrated among a smaller number of Homology’s competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with Homology in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, Homology’s programs. Homology’s competitors may also develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that Homology may develop in the future. The key competitive factors affecting the success of all of Homology’s programs are likely to be their efficacy, safety, convenience and availability of reimbursement.

Furthermore, Homology has relied upon a combination of patents and trade secret protection, as well as license and confidentiality agreements to protect the intellectual property related to its proprietary technologies, product candidate development programs and product development candidates. Homology’s success has depended in large part on its ability to secure and maintain patent protection in the United States and other countries with respect to Homology’s former and any future product development candidates. Moreover, Homology’s industry is characterized by the existence of large numbers of patents and frequent allegations of patent infringement. If, therefore, Homology is unable to obtain and maintain patent protection for its technology and products or if the scope of the patent protection obtained or in-licensed is not sufficiently broad or if the validity of such patent is threatened, it could create opportunities for competitors to enter the market or dissuade other companies from collaborating with it to develop products and technology, any of which would hurt Homology’s competitive position and could impair its ability to successfully commercialize its product development candidates in the future. For more information regarding these competitive risks, see Item 1A. “Risk Factors—Risks Related to Homology’s Intellectual Property.”

Intellectual Property

Homology’s success depended in large part upon its ability to secure and maintain proprietary protection for its technologies and products and to operate without infringing the proprietary rights of others. Homology’s policy is to protect its proprietary position by, among other methods, filing, or collaborating with its licensors to file, U.S. and foreign patent applications related to its proprietary technology, inventions, and improvements and trademarks that are important to the development and implementation of its business. Homology requires employees who are inventors on any company-owned patent applications to assign the rights to it. Also, Homology uses other forms of protection, particularly where it does not believe patent protection is appropriate or obtainable. Homology relies on trade secrets, technical know-how, and continuing innovation to develop and maintain its competitive advantage. In addition, Homology relies on confidentiality agreements with its employees, consultants, and other advisors to protect its proprietary information. Homology’s policy is to require third parties that receive material confidential information to enter into confidentiality agreements with it.

Homology’s patent portfolio includes a combination of issued patents and pending patent applications that are licensed from third parties. Homology is exploring strategic alternatives for certain of its programs and the related intellectual property, and is in the process of abandoning non-core intellectual property.

 

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For any individual patent, the term depends on the applicable law in the country in which the patent is granted. In most countries where Homology has filed patent applications or in-licensed patents and patent applications, patents have a term of 20 years from the application filing date or earliest claimed non-provisional priority date. In the United States, the patent term is 20 years but may be shortened if a patent is terminally disclaimed over another patent that expires earlier. The term of a U.S. patent may also be lengthened by a patent term adjustment, in order to address administrative delays by the United States Patent and Trademark Office in granting a patent.

In the United States, the term of a patent that covers an FDA-approved drug or biologic may be eligible for patent term extension in order to restore the period of a patent term lost during the premarket FDA regulatory review process. The Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Act, permits a patent term extension of up to five years beyond the natural expiration of the patent. The patent term restoration period is generally equal to the regulatory review period for the approved product which period occurs after the date the patent issued, subject to certain exceptions. Only one patent may be extended for a regulatory review period for any product, and the application for the extension must be submitted prior to the expiration of the patent. In the future, Homology may decide to apply for restoration of patent term for one of its currently owned or licensed patents to extend its current expiration date, depending on the expected length of the clinical studies and other factors involved in the filing of the relevant Biologics License Application, or BLA. Similarly, certain foreign jurisdictions also have mechanisms for extending patent term and, to the extent Homology has granted patents that are eligible, Homology may decide to apply for patent term extensions in those jurisdictions.

U.S. Patent Term Restoration and Marketing Exclusivity

Depending upon the timing, duration and specifics of the FDA approval of the use of Homology’s product candidates, some of Homology’s U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent restoration term of up to five years as compensation for patent term lost during product development and the FDA regulatory review process. However, patent term restoration cannot extend the remaining term of a patent beyond a total of 14 years from the product’s approval date. The patent term restoration period is generally equal to the regulatory review period for the approved product which period occurs after the date the patent issued, subject to certain exceptions. Only one patent may be extended for a regulatory review period for any product, and the application for the extension must be submitted prior to the expiration of the patent. The U.S. Patent and Trademark Office, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration. In the future, Homology may intend to apply for restoration of patent term for one of Homology’s currently owned or licensed patents to extend its current expiration date, depending on the expected length of the clinical studies and other factors involved in the filing of the relevant BLA.

For patents that might expire during the BLA review phase, the patent owner may request an interim patent term extension. If eligible, an interim patent term extension may be granted for a period of not more than one year. The patent owner may apply for not more than four subsequent interim extensions. Any interim extension granted will not be longer than the maximum period of extension allowed post-approval.

Licensed Intellectual Property

Certain of Homology’s issued patents and pending patent applications are exclusively licensed to it from COH.

The City of Hope Portfolio

In April 2016, Homology exclusively licensed two families of patents and patent applications directed to novel AAV capsids and their manufacture and methods of use, including their use in genome editing from COH.

 

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These two families of patents and patent applications together include thirteen granted patents in the United States, seven foreign granted patents, and 15 pending applications in the United States, Europe, Canada, Australia and other selected countries in Latin America and Asia. The first family of issued patents and patent applications relates to Homology’s novel AAV vectors and their use in cellular transduction. The ten issued U.S. patents in this family are expected to expire in 2031 and may be extended by up to five years in the United States via patent term extension depending on the regulatory pathway of the products covered by such patents. The second family includes three issued U.S. patents relating to Homology’s AAV vectors and their use in genome editing. The issued patents in this family are expected to expire in 2035 and may be extended by up to five years in the United States and in certain other countries via patent term extension depending on the regulatory pathway of the products covered by such patents.

Trademarks

Homology’s trademarks Homology Medicines, HMI, the H logo, the HOMOLOGY MEDICINES, INC. logo and AMENDR, are pending or registered in the United States and/or certain international countries. As of September 30, 2023, Homology owned three registered trademarks and two pending trademark applications in the United States, 38 registered foreign trademarks, and seven pending foreign trademark applications.

Strategic Collaborations

City of Hope License Agreement

In April 2016, Homology entered into an exclusive license agreement with City of Hope, or COH, pursuant to which COH granted Homology an exclusive, sublicensable, worldwide license to certain AAV vector-related patents and know-how owned by COH to develop, manufacture, use and commercialize products and services covered by such patents and know-how in any and all fields. COH also granted Homology a non-exclusive, sublicensable, worldwide license to certain background patents owned by COH to develop, manufacture, use and commercialize licensed products and licensed services in any and all fields.

Under the agreement, Homology paid COH an initial licensing fee of $75,000, and made a subsequent payment of $4.5 million representing a percentage of sublicensing revenue. Homology is also required to pay COH an annual license maintenance fee; up to a total of $3.2 million in potential milestone fees; a royalty in the low single-digit percentages on net sales of licensed products or services, subject to certain reductions in certain circumstances, with a certain annual minimum royalty; and low double-digit percentages of sublicensing revenues. As partial consideration for the licenses granted under the agreement, Homology issued 154,837 shares of its common stock to COH.

The COH agreement will expire on a country-by-country and on a licensed patent-by-licensed patent basis upon the expiration of the last-to-expire valid claim of such patent in such country. Homology agreed to use commercially reasonable efforts to develop and commercialize licensed products and licensed services. If Homology fails to achieve certain diligence milestones, COH may terminate the agreement or convert the exclusive rights under the agreement from exclusive to non-exclusive. Either party may terminate the agreement in the event of the other party’s material breach, subject to an opportunity to cure, and in the event of the other party’s bankruptcy or insolvency. Homology may terminate the agreement for convenience.

On August 6, 2021, Homology received notice from COH that Homology did not accomplish at least one of the partnering milestones by the applicable deadline, as set forth in the COH License. This notice does not affect Homology’s exclusive license in the field of mammalian therapeutics, including all human therapeutics, associated diagnostics, and target validation, or the Mammalian Therapeutic Field, where Homology retains exclusive rights. Instead, the notice served as written notice that the exclusive license granted pursuant to the COH License in all fields except the Mammalian Therapeutic Field converted from exclusive to non-exclusive effective as of September 20, 2021, which was forty-five days from the receipt of notice. In connection with the

 

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conversion, any royalty obligations and sublicensee fees relating to fields outside of the Mammalian Therapeutic Field shall be reduced by a certain percentage. This change to Homology’s exclusive worldwide license with COH does not impact any of Homology’s therapeutic product candidates, including HMI-102, HMI-103, HMI-203, HMI-204 and HMI-104.

Government Regulation and Product Approval

Governmental authorities in the U.S., at the federal, state and local level, and other countries extensively regulate, among other things, the research, development, testing, manufacture, labeling, packaging, promotion, storage, advertising, distribution, marketing, post-approval monitoring and reporting and export and import of products such as those Homology is developing. The processes for obtaining regulatory approvals in the United States and in foreign countries and jurisdictions, along with subsequent compliance with applicable statutes and regulations and other regulatory authorities, are extensive and require the expenditure of substantial time and financial resources. For the purposes of this Section, the term “gene therapy” includes both traditional gene therapy products as well as gene editing and Homology’s gene integration product candidates.

FDA Approval Process

If Homology resumes development of its product candidates, Homology expects its product candidates to be regulated as biologics. Biological products, including gene therapy products, are subject to extensive regulation by the FDA under the Federal Food, Drug, and Cosmetic Act, or FDCA, and the Public Health Service Act, or PHS Act, and other federal, state, local and foreign statutes and regulations. Both the FDCA and the PHS Act and their corresponding regulations govern, among other things, the research, development, safety, testing, packaging, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of biological products.

Homology, along with third-party contractors, will be required to navigate the various preclinical, clinical and commercial approval requirements of the governing regulatory agencies of the countries in which Homology wishes to conduct studies or seek approval or licensure of its product candidates. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources.

U.S. Biological Products Development Process

The process required by the FDA before a biologic may be marketed in the United States generally involves the following:

 

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completion of extensive nonclinical, sometimes referred to as preclinical laboratory tests, animal studies and formulation studies in accordance with applicable regulations, including good laboratory practices, or GLP, requirements;

 

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submission to the FDA of an IND, which must become effective before human clinical trials may begin;

 

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approval by an independent Institutional Review Board, or IRB, or ethics committee at each clinical site before the trial is commenced;

 

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performance of adequate and well-controlled human clinical trials according to good clinical practice, or GCP, requirements and any additional requirements needed for the protection of human research subjects and their health information, to establish the safety and efficacy of the proposed biological product for its intended use;

 

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preparation and submission to the FDA of a BLA for marketing approval that includes substantive evidence of safety, purity and potency from results of nonclinical testing and clinical trials;

 

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a determination by the FDA within 60 days of its receipt of a BLA to file the application for review;

 

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  •  

completion of an FDA Advisory Committee review, if applicable;

 

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satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the biological product is produced to assess compliance with GMP to assure that the facilities, methods and controls are adequate to preserve the biological product’s identity, strength, quality and purity;

 

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potential FDA audit of the nonclinical and clinical study sites that generated the data in support of the BLA; and

 

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FDA review and approval, or licensure, of the BLA.

Before testing any biological product candidate, including a gene therapy product candidate, in humans, the product candidate enters the preclinical testing stage. Preclinical tests, also referred to as nonclinical studies, include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies to assess the potential safety and activity of the product candidate. The conduct of the preclinical tests must comply with federal regulations and requirements, including GLP.

The clinical study sponsor must submit the results of the preclinical tests, together with manufacturing and controls, information about product chemistry, analytical data, any available clinical data or literature and a proposed clinical protocol, to the FDA as part of an IND. An IND is a request for authorization from the FDA to administer an investigational new drug to humans. Some preclinical testing, such as reproductive toxicity tests and carcinogenicity in animals, may continue even after the IND is submitted. The IND automatically becomes effective 30 days after receipt by the FDA, after which human clinical trials may begin unless the FDA places the clinical study on a clinical hold within that 30-day time period. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical study can begin.

In addition to the IND submission process, under the National Institutes of Health, or NIH, Guidelines for Research Involving Recombinant DNA Molecules, or the NIH Guidelines, supervision of human gene transfer trials includes evaluation and assessment by an institutional biosafety committee, or IBC, a local institutional committee that reviews and oversees research utilizing recombinant or synthetic nucleic acid molecules at that institution. The IBC assesses the safety of the research and identifies any potential risk to public health or the environment, and such review may result in some delay before initiation of a clinical trial. While the NIH Guidelines are not mandatory unless the research in question is being conducted at or sponsored by institutions receiving NIH funding of recombinant or synthetic nucleic acid molecule research, many companies and other institutions not otherwise subject to the NIH Guidelines voluntarily follow them.

Clinical trials involve the administration of the biological product candidate to healthy volunteers or patients under the supervision of qualified investigators, generally physicians not employed by or under the study sponsor’s control. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical study, dosing procedures, subject selection and exclusion criteria, the efficacy measurements to be evaluated and the parameters to be used to monitor subject safety, including stopping rules that assure a clinical study will be stopped if certain adverse events should occur. Each protocol and any amendments to the protocol must be submitted to the FDA as part of the IND. Clinical trials must be conducted and monitored in accordance with the FDA’s regulations comprising the GCP requirements, including the requirement that all research subjects provide informed consent. Further, each clinical study must be reviewed and approved by an independent IRB or ethics committee at or servicing each institution at which the clinical study will be conducted. An IRB is charged with protecting the welfare and rights of study participants and considers such items as whether the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the form and content of the informed consent that must be signed by each clinical study subject or his or her legal representative and must monitor the clinical study until completed. Some studies also include oversight by an independent group of qualified experts organized by the clinical study sponsor, known as a data safety monitoring board or a data monitoring committee, which provides guidance for whether or not a study may move forward at designated check points based on access to certain data

 

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from the study and may halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or other grounds, such as no demonstration of efficacy. There are also requirements governing the reporting of ongoing clinical studies and clinical study results to public registries.

Human clinical trials are typically conducted in three sequential phases that may overlap or be combined:

 

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Phase 1. The biological product candidate is initially introduced into healthy human subjects and tested for safety. In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.

 

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Phase 2. The biological product candidate is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance, optimal dosage and dosing schedule.

 

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Phase 3. The biological product candidate is further evaluated for dosage, clinical efficacy, potency, and safety in an expanded patient population, generally at geographically dispersed clinical study sites. These clinical trials are intended to establish the overall risk/benefit ratio of the product and provide an adequate basis for product labeling.

In some cases, the FDA may require, or companies may voluntarily pursue, additional clinical trials after a product is approved to gain more information about the product. These so-called Phase 4 studies may also be made a condition to approval of the BLA.

During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data, and clinical study investigators. Annual progress reports detailing the results of the clinical trials and nonclinical studies performed since the last progress report, among other information, must be submitted to the FDA. Written IND safety reports must be promptly submitted to the FDA and the investigators for serious and unexpected adverse events, any findings from other trials, tests in laboratory animals or in vitro testing that suggest a significant risk for human subjects, or any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure. The sponsor must submit an IND safety report within 15 calendar days after the sponsor determines that the information qualifies for reporting. The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction within seven calendar days after the sponsor’s initial receipt of the information. The FDA or the sponsor or its data safety monitoring board may suspend or permanently discontinue a clinical study at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk or the clinical study is not being conducted in accordance with FDA regulations. Similarly, an IRB can suspend or terminate approval of a clinical study at its institution if the clinical study is not being conducted in accordance with the IRB’s requirements or if the biological product candidate has been associated with unexpected serious harm to patients. The FDA and the IRB may also halt, terminate or impose other conditions if either believes the patients are subject to unacceptable risk.

Concurrent with clinical trials, companies usually complete additional animal trials and must also develop additional information about the physical characteristics of the biological product candidate as well as finalize a process for manufacturing the product in commercial quantities in accordance with GMP requirements. To help reduce the risk of the introduction of adventitious agents with use of biological products, the PHS Act emphasizes the importance of manufacturing control for products whose attributes cannot be precisely defined. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, the sponsor must develop methods for testing the identity, strength, quality, potency and purity of the final biological product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the biological product candidate does not undergo unacceptable deterioration over its shelf life.

 

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U.S. Review and Approval Processes

After the completion of clinical trials of a biological product candidate, FDA approval of a BLA must be obtained before commercial marketing and distribution of the biological product. The BLA must include results of product development, laboratory and animal trials, human trials, information on the manufacture, pharmacology, chemistry and controls of the product, proposed labeling and other relevant information. In addition, under the Pediatric Research Equity Act, or PREA, a BLA or supplement to a BLA must contain data to assess the safety and effectiveness of the biological product candidate for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The sponsor or FDA may request a deferral of pediatric clinical trials for some or all of the pediatric subpopulations. A deferral may be granted for several reasons, including a finding that the drug or biologic is ready for approval for use in adults before pediatric clinical trials are complete or that additional safety or effectiveness data needs to be collected before the pediatric clinical trials begin. Unless otherwise required by regulation, PREA does not apply to any biological product for an indication for which orphan designation has been granted.

Under the Prescription Drug User Fee Act, or PDUFA, as amended, each BLA must be accompanied by a user fee. The FDA adjusts the PDUFA user fees on an annual basis. PDUFA also imposes an annual program fee for marketed products. Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first human drug application filed by a small business. Additionally, no user fees are assessed on BLAs for products designated as orphan drugs, unless the product also includes a non-orphan indication.

Within 60 days following submission of the application, the FDA reviews the submitted BLA to determine if it is substantially complete before the agency accepts it for filing. The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at the time of submission and may request additional information. In this event, the BLA must be resubmitted with the additional information. The resubmitted application also is subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review of the BLA. Under PDUFA, the FDA has agreed to certain performance goals to complete the review of BLAs. For example, the FDA may give a priority review to BLAs submitted for biological products that are designed to treat a serious or life-threatening disease or condition, and if approved, would offer a significant improvement in safety or efficacy compared to marketed products. A priority review means that the goal for the FDA to review an application is six months, rather than the standard review of ten months under current PDUFA guidelines. Under the current PDUFA agreement, these six-and ten-month review periods are measured from the “filing” date rather than the receipt date for original BLAs, which typically adds approximately two months to the timeline for review and decision from the date of submission.

The FDA reviews the BLA to determine, among other things, whether the proposed product is safe, pure and potent, or effective, for its intended use, and whether the product is being manufactured in accordance with GMP requirements to assure and preserve the product’s identity, safety, strength, quality, potency and purity. The FDA may refer applications for novel biological products or biological products that present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.

Before approving a BLA, the FDA will inspect the facilities at which the product is manufactured. The FDA will not approve the product unless it determines that the manufacturing processes and facilities are in compliance with GMP requirements and are adequate to assure consistent production of the product within required specifications. Additionally, before approving a BLA, the FDA will typically inspect one or more clinical sites to assure that the clinical trials were conducted in compliance with GCP.

After the FDA evaluates a BLA, conducts inspections of manufacturing facilities where the investigational product and/or its drug substance will be produced and conducts inspections at select clinical sites, the FDA may

 

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issue an approval letter or a Complete Response Letter, or CRL. An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications. A CRL will describe all of the deficiencies that the FDA has identified in the BLA, except that where the FDA determines that the data supporting the application are inadequate to support approval, the FDA may issue the CRL without first conducting required inspections, testing submitted product lots, and/or reviewing proposed labeling. In issuing the CRL, the FDA may recommend actions that the applicant might take to place the BLA in condition for approval, including requests for additional information or clarification. The FDA may delay or refuse approval of a BLA if applicable regulatory criteria are not satisfied, require additional testing or information and/or require post-marketing testing and surveillance to monitor safety or efficacy of a product.

If regulatory approval of a product is granted, such approval will be granted for particular indications and may entail limitations on the indicated uses for which such product may be marketed. For example, the FDA may approve the BLA with a Risk Evaluation and Mitigation Strategy, or REMS, to ensure the benefits of the product outweigh its potential risks. A REMS is a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use, and could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. The FDA also may condition approval on, among other things, changes to proposed labeling or the development of adequate controls and specifications. The requirement for a REMS can materially affect the potential market and profitability of the product.

Once approved, the FDA may withdraw the product approval if compliance with pre- and post-marketing requirements is not maintained or if problems occur after the product reaches the marketplace. Changes to some of the conditions established in an approved BLA, including changes in indications, product labeling, manufacturing processes or facilities, require submission and FDA approval of a new BLA or BLA supplement before the change can be implemented. A BLA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing BLA supplements as it does in reviewing BLAs. The FDA may require one or more post-market studies or surveillance to further assess and monitor the product’s safety and effectiveness after commercialization, and may limit further marketing of the product based on the results of these post-marketing studies.

Orphan Drug Designation

The FDA may grant orphan drug designation to drugs or biologics intended to treat a rare disease or condition that affects fewer than 200,000 individuals in the United States, or if it affects more than 200,000 individuals in the United States, there is no reasonable expectation that the cost of developing and marketing the drug or biologic for this type of disease or condition will be recovered from its sales in the United States. Orphan product designation must be requested before submitting a BLA. After the FDA grants orphan product designation, the identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. Orphan product designation does not convey any advantage in or shorten the duration of the regulatory review and approval process.

In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and BLA user-fee waivers. In addition, if a product receives the first FDA approval for the disease or condition for which it has orphan designation, the product is entitled to orphan drug exclusivity, which means the FDA may not approve any other application, including a full BLA, to market the same drug or biologic for the same disease or condition for a period of seven years, except in limited circumstances, such as a showing of clinical superiority over the product with orphan exclusivity or where the manufacturer with orphan exclusivity is unable to assure sufficient quantities of the approved orphan-designated product. Competitors, however, may receive approval of different products for the disease or condition for which the orphan product has exclusivity or obtain approval for the same product but for a different disease or condition for which the orphan product has exclusivity. Orphan product exclusivity also could block

 

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the approval of a product for seven years if a competitor obtains approval of the same biological product as defined by the FDA or if such product candidate is determined to be contained within the competitor’s product for the same condition or disease. If a drug or biological product designated as an orphan product receives marketing approval for a disease or condition broader than what is designated, it may not be entitled to orphan product exclusivity. In addition, exclusive marketing rights in the United States may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition.

Rare Pediatric Disease Priority Review Voucher Program

In 2012, Congress authorized the FDA to award priority review vouchers to sponsors of certain rare pediatric disease product applications. This program is designed to encourage development of new drug and biological products for prevention and treatment of certain rare pediatric diseases. Specifically, under this program, a sponsor who receives an approval for a drug or biologic for a “rare pediatric disease” may qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product. The sponsor of a rare pediatric disease drug product receiving a priority review voucher may transfer (including by sale) the voucher to another sponsor. The voucher may be further transferred any number of times before the voucher is used, as long as the sponsor making the transfer has not yet submitted the application. The FDA may also revoke any priority review voucher if the rare pediatric disease drug for which the voucher was awarded is not marketed in the U.S. within one year following the date of approval.

For purposes of this program, a “rare pediatric disease” is a (a) serious or life-threatening disease in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents; and (b) rare diseases or conditions within the meaning of the Orphan Drug Act. Congress has only authorized the Rare Pediatric Disease Priority Review Voucher program until September 30, 2024. Consequently, sponsors of marketing applications approved after that date will not receive the voucher unless Congress reauthorizes the Rare Pediatric Disease Priority Review Voucher program before that time. However, even if the program is not reauthorized, if a drug candidate receives Rare Pediatric Disease Designation before October 1, 2024, the sponsor of the marketing application for such drug will be eligible to receive a voucher if the application for the designated drug is approved by the FDA before October 1, 2026.

Expedited Development and Review Programs

The FDA has a Fast Track program that is intended to expedite or facilitate the process for reviewing new biological products that meet certain criteria. Specifically, biological products are eligible for Fast Track designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition. Fast Track designation applies to the combination of the product candidate and the specific indication for which it is being studied. The sponsor of a biologic product candidate may request that the FDA designate the biologic as a Fast Track product at any time during the clinical development of the product. The FDA must determine if the biologic product candidate qualifies for Fast Track designation within 60 days of receipt of the sponsor’s request. With regard to a Fast Track product, the FDA may consider for review sections of the marketing application on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the application, the FDA agrees to accept sections of the application and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the application.

A biological product candidate intended to treat a serious or life-threatening disease or condition may also be eligible for Breakthrough Therapy designation to expedite its development and review. A biologic can receive Breakthrough Therapy designation if preliminary clinical evidence indicates that the biologic, alone or in combination with one or more other drugs or biologics, may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in

 

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clinical development. The designation includes all of the Fast Track program features, as well as more intensive FDA interaction and guidance beginning as early as Phase 1 and an organizational commitment to expedite the development and review of the product candidate, including involvement of senior managers.

Any product candidate submitted to the FDA for marketing, including a product candidate with a Fast Track designation or Breakthrough Therapy designation, may be eligible for other types of FDA programs intended to expedite development and review, such as priority review and accelerated approval. A BLA is eligible for priority review if the biological product candidate has the potential to treat a serious or life-threatening condition and, if approved, would provide a significant improvement in the treatment, diagnosis or prevention of a disease compared to marketed products. The FDA will attempt to direct additional resources to the evaluation of an application for a new biological product designated for priority review in an effort to facilitate the review. Additionally, a product candidate may be eligible for accelerated approval. Biological product candidates studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may be eligible for accelerated approval, which means that such product candidates be approved on the FDA’s determination that the product candidate has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit, or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. As a condition of approval, the FDA may require that a sponsor of a biological product receiving accelerated approval perform adequate and well-controlled confirmatory clinical studies to verify and describe the predicted clinical benefit and, under FDORA, the FDA may require, as appropriate, that such trials be underway prior to approval or within a specific time period after the date of approval for a product granted accelerated approval. Failure to conduct required confirmatory trials in a timely manner, or to verify a clinical benefit during such confirmatory trials, will allow the FDA to withdraw the approved biologic product from the market on an expedited basis. In addition, the FDA generally requires, unless otherwise informed by the agency, pre-approval of promotional materials for products approved under the accelerated approval pathway, which could adversely impact the timing of the commercial launch of the product.

Moreover in 2017, the FDA established the Regenerative Medicine Advanced Therapy, or RMAT, designation as part of its implementation of the 21st Century Cures Act. An investigational drug is eligible for RMAT designation if: (1) it meets the definition of a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, with limited exceptions; (2) it is intended to treat, modify, reverse, or cure a serious disease or condition; and (3) preliminary clinical evidence indicates that the investigational drug has the potential to address unmet medical needs for such disease or condition. In a February 2019 final guidance, the FDA also stated that certain gene therapies that lead to a sustained effect on cells or tissues may meet the definition of a regenerative medicine therapy. RMAT designation provides potential benefits that include more frequent meetings with FDA to discuss the development plan for the product candidate, and eligibility for rolling review of BLAs and priority review. Product candidates granted RMAT designation may also be eligible for accelerated approval if the relevant statutory conditions are met.

Fast Track designation, priority review, RMAT designation and Breakthrough Therapy designation do not change the standards for approval but may expedite the development or approval process. Even if Homology receives one or both of these designations for its product candidates, the FDA may later decide that Homology’s product candidates no longer meet the conditions for qualification. In addition, receiving these designations may not provide Homology with a material commercial advantage.

Post-Approval Requirements

Maintaining substantial compliance with applicable federal, state, and local statutes and regulations requires the expenditure of substantial time and financial resources. Rigorous and extensive FDA regulation of biological products continues after approval, particularly with respect to GMP requirements, record-keeping, reporting of

 

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adverse experiences, periodic reporting, product sampling and distribution, and advertising and promotion of the product. Biological product manufacturers and other entities involved in the manufacture and distribution of approved biological products are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with GMP requirements and other laws. Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain GMP compliance. Discovery of problems with a product after approval may result in restrictions on a product, manufacturer, or holder of an approved BLA, including withdrawal of the product from the market. In addition, changes to the manufacturing process or facility generally require prior FDA approval before being implemented and other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject to further FDA review and approval.

After a BLA is approved, the product also may be subject to official lot release. As part of the manufacturing process, the manufacturer is required to perform certain tests on each lot of the product before it is released for distribution. If the product is subject to official release by the FDA, the manufacturer submits samples of each lot of product to the FDA together with a release protocol showing a summary of the history of manufacture of the lot and the results of all of the manufacturer’s tests performed on the lot. The FDA also may perform certain confirmatory tests on lots of some products, such as viral vaccines, before releasing the lots for distribution by the manufacturer. In addition, the FDA conducts laboratory research related to the regulatory standards on the safety, purity, potency, and effectiveness of biological products.

To help reduce the increased risk of the introduction of adventitious agents, the PHS Act emphasizes the importance of manufacturing controls for products whose attributes cannot be precisely defined. The PHS Act also provides authority to the FDA to immediately suspend biologics licenses in situations where there exists a danger to public health, to prepare or procure products in the event of shortages and critical public health needs, and to authorize the creation and enforcement of regulations to prevent the introduction or spread of communicable diseases within the United States.

The FDA closely regulates the marketing, labeling, advertising and promotion of biologics. A company can make only those claims relating to safety and efficacy, purity and potency that are consistent with the provisions of the FDA-approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. Failure to comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties. Physicians may prescribe legally available products for uses that are not described in the product’s labeling and that differ from those tested and approved by the FDA. Such off-label uses are common across medical specialties. Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, restrict manufacturer’s communications on the subject of off-label use of their products.

Discovery of previously unknown problems or the failure to comply with the applicable regulatory requirements may result in restrictions on the marketing of a product or withdrawal of the product from the market as well as possible civil or criminal sanctions. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or after approval, may subject an applicant or manufacturer to administrative or judicial civil or criminal sanctions and adverse publicity. FDA sanctions could include refusal to approve pending applications, withdrawal of an approval, clinical hold, warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, mandated corrective advertising or communications with doctors, debarment, restitution, disgorgement of profits, or civil or criminal penalties.

Biosimilars and Exclusivity

The Patient Protection and Affordable Care Act, or Affordable Care Act, signed into law on March 23, 2010, includes a subtitle called the Biologics Price Competition and Innovation Act of 2009, or BPCIA, which created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-licensed reference biological product.

 

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Biosimilarity, which requires that there be no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency, can be shown through analytical studies, animal studies, and a clinical study or studies. Interchangeability requires that a product is biosimilar to the reference product and the product must demonstrate that it can be expected to produce the same clinical results as the reference product in any given patient and, for products that are administered multiple times to an individual, the biologic and the reference biologic may be alternated or switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic.

Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that the reference product was first licensed by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from the date on which the reference product was first licensed. During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing the sponsor’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of their product. The BPCIA also created certain exclusivity periods for biosimilars approved as interchangeable products. At this juncture, it is unclear whether products deemed “interchangeable” by the FDA will, in fact, be readily substituted by pharmacies, which are governed by state pharmacy law.

A biological product can also obtain pediatric market exclusivity in the United States. Pediatric exclusivity, if granted, adds six months to existing exclusivity periods and patent terms. This six-month exclusivity, which runs from the end of other exclusivity protection or patent term, may be granted based on the voluntary completion of a pediatric study in accordance with an FDA-issued “Written Request” for such a study.

Other Healthcare Laws and Compliance Requirements

Pharmaceutical companies are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which they conduct their business. Such laws include, without limitation, state and federal anti-kickback, fraud and abuse, false claims and transparency laws and regulations regarding drug pricing and payments and other transfers of value made to physician and other licensed healthcare professionals. If their operations are found to be in violation of any of such laws or any other governmental regulations that apply, they may be subject to penalties, including, without limitation, civil and criminal penalties, damages, fines, the curtailment or restructuring of operations, exclusion from participation in federal and state healthcare programs and individual imprisonment. See section entitled “Risk Factors—Risks Related to Healthcare Laws and Other Legal Compliance Matters—Homology’s business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable healthcare regulatory laws, which could expose Homology to penalties.”

Moreover, analogous state and foreign laws and regulations may be broader in scope than the provisions described above and may apply regardless of payor. These laws and regulations may differ from one another in significant ways, thus further complicating compliance efforts. For instance, in the European Union, or EU, many EU member states have adopted specific anti-gift statutes that further limit commercial practices for medicinal products, in particular vis-à-vis healthcare professionals and organizations. Additionally, there has been a recent trend of increased regulation of payments and transfers of value provided to healthcare professionals or entities and many EU member states have adopted national “Sunshine Acts” which impose reporting and transparency requirements (often on an annual basis), similar to the requirements in the United States, on pharmaceutical companies. Certain countries also mandate implementation of commercial compliance programs, or require disclosure of marketing expenditures and pricing information. Violation of any of such laws or any other governmental regulations that apply may result in penalties, including, without limitation, significant administrative, civil and criminal penalties, damages, fines, disgorgement, additional reporting obligations and oversight if a manufacturer becomes subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, the curtailment or restructuring of operations, exclusion from participation in governmental healthcare programs and imprisonment.

 

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Coverage and Reimbursement

Sales of any product depend, in part, on the extent to which such product will be covered by third-party payors, such as federal, state, and foreign government healthcare programs, commercial insurance and managed healthcare organizations, and the level of reimbursement for such product by third-party payors. Decisions regarding the extent of coverage and amount of reimbursement to be provided are made on a plan-by-plan basis. These third-party payors are increasingly reducing reimbursements for medical products, drugs and services. Moreover, for drugs and biologics administered under the supervision of a physician, obtaining coverage and adequate reimbursement may be particularly difficult because of the higher prices often associated with such products. In addition, the U.S. government, state legislatures and foreign governments have continued implementing cost-containment programs, including price controls, restrictions on coverage and reimbursement and requirements for substitution of generic products. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit sales of any product. Decreases in third-party reimbursement for any product or a decision by a third-party payor not to cover a product could reduce physician usage and patient demand for the product and also have a material adverse effect on sales. See section entitled “Risk Factors—Risks Related to Healthcare Laws and Other Legal Compliance Matters—The successful commercialization of Homology’s product candidates will depend in part on the extent to which governmental authorities and health insurers establish adequate coverage, reimbursement levels and pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for Homology’s product candidates, if approved, could limit Homology’s ability to market those products and decrease its ability to generate revenue.”

In addition, in many countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing and reimbursement vary widely from country to country. In the EU, governments influence the price of products through their pricing and reimbursement rules and control of national healthcare systems that fund a large part of the cost of those products to consumers. Member states are free to restrict the range of pharmaceutical products for which their national health insurance systems provide reimbursement, and to control the prices and reimbursement levels of pharmaceutical products for human use. Some jurisdictions operate positive and negative list systems under which products may only be marketed once a reimbursement price has been agreed to by the government. Member states may approve a specific price or level of reimbursement for the pharmaceutical product, or alternatively adopt a system of direct or indirect controls on the profitability of the company responsible for placing the pharmaceutical product on the market, including volume-based arrangements, caps and reference pricing mechanisms. To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost effectiveness of a particular product to currently available therapies. Other member states allow companies to fix their own prices for medicines, but monitor and control company profits. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of Homology’s products. The downward pressure on healthcare costs in general, particularly prescription products, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products. In addition, in some countries, cross border imports from low priced markets exert a commercial pressure on pricing within a country.

Healthcare Reform

The United States and several other jurisdictions are considering, or have already enacted, a number of legislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell any of our product candidates profitably, if approved. Among policy-makers and payers in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access to healthcare. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives. There have been, and likely will continue to be, legislative and regulatory proposals at the federal and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. See section entitled “Risk Factors – Risks Related to Healthcare Laws and Other Legal Compliance

 

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Matters – If Homology resumes development of its product candidates, enacted and future healthcare legislation could increase the difficulty and cost for Homology to obtain marketing approval of and commercialize its product candidates and may affect the prices Homology may set.”

The continuing efforts of the government, insurance companies, managed care organizations and other payers of healthcare services to contain or reduce costs of healthcare may adversely affect:

 

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the demand for any of our product candidates, if approved;

 

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the ability to set a price that we believe is fair for any of our product candidates, if approved;

 

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our ability to generate revenues and achieve or maintain profitability;

 

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the level of taxes that we are required to pay; and

 

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the availability of capital.

Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical and biologic products. We cannot be sure whether additional legislative changes will be enacted, or whether FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of our product candidates, if any, may be. In addition, increased scrutiny by Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirements.

Moreover, increasing efforts by governmental and third-party payors in the United States and abroad to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for our product candidates. There has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.

Similar political, economic and regulatory developments are occurring in the EU and may affect the ability of pharmaceutical companies to profitably commercialize their products. In addition to continuing pressure on prices and cost containment measures, legislative developments at the EU or member state level may result in significant additional requirements or obstacles. The delivery of healthcare in the EU, including the establishment and operation of health services and the pricing and reimbursement of medicines, is almost exclusively a matter for national, rather than EU, law and policy. National governments and health service providers have different priorities and approaches to the delivery of health care and the pricing and reimbursement of products in that context. In general, however, the healthcare budgetary constraints in most EU member states have resulted in restrictions on the pricing and reimbursement of medicines by relevant health service providers. Coupled with ever-increasing EU and national regulatory burdens on those wishing to develop and market products, this could restrict or regulate post-approval activities and affect the ability of pharmaceutical companies to commercialize their products. In international markets, reimbursement and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies.

On December 13, 2021, Regulation No 2021/2282 on Health Technology Assessment, or HTA, amending Directive 2011/24/EU, was adopted in the EU. While the regulation entered into force in January 2022, it will only begin to apply from January 2025 onwards, with preparatory and implementation-related steps to take place in the interim. Once the regulation becomes applicable, it will have a phased implementation depending on the concerned products. This regulation intends to boost cooperation among EU member states in assessing health technologies, including new medicinal products, and providing the basis for cooperation at the EU level for joint clinical assessments in these areas. The regulation will permit EU member states to use common HTA tools,

 

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methodologies, and procedures across the EU, working together in four main areas, including joint clinical assessment of the innovative health technologies with the most potential impact for patients, joint scientific consultations whereby developers can seek advice from HTA authorities, identification of emerging health technologies to identify promising technologies early, and continuing voluntary cooperation in other areas. Individual EU member states will continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) aspects of health technology, and making decisions on pricing and reimbursement.

We expect that the healthcare reform measures that have been adopted and may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved product and could seriously harm our future revenues. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize our products.

Data Privacy and Security Laws

Numerous state, federal and foreign laws, including consumer protection laws and regulations, govern the collection, dissemination, use, access to, confidentiality and security of personal information, including health-related information. In the United States, numerous laws and regulations, including data breach notification laws, health information privacy and security laws, and consumer protection laws and regulations that govern the collection, use, disclosure, and protection of health-related and other personal information and could apply to Homology’s operations or the operations of Homology’s partners. In addition, certain foreign laws govern the privacy and security of personal data, including health-related data. Failure to comply with these laws, where applicable, can result in the imposition of significant civil and/or criminal penalties and private litigation. Privacy and security laws, regulations, and other obligations are constantly evolving, may conflict with each other to complicate compliance efforts, and can result in investigations, proceedings, or actions that lead to significant civil and/or criminal penalties and restrictions on data processing.

Additional Regulation

In addition to the foregoing, state and federal laws regarding environmental protection and hazardous substances, including the Occupational Safety and Health Act, the Resource Conservancy and Recovery Act and the Toxic Substances Control Act, affect Homology’s business. These and other laws govern Homology’s use, handling and disposal of various biological, chemical and radioactive substances used in, and wastes generated by, its operations. If Homology’s operations result in contamination of the environment or expose individuals to hazardous substances, Homology could be liable for damages and governmental fines. Homology believes that it is in material compliance with applicable environmental laws and that continued compliance therewith will not have a material adverse effect on its business. Homology cannot predict, however, how changes in these laws may affect its future operations.

Government Regulation Outside of the United States

In addition to regulations in the United States, Homology may be subject to a variety of regulations in other jurisdictions, for instance in the European Union, or EU, governing, among other things, clinical trials, marketing authorizations, post-marketing authorization requirements and any commercial sales and distribution of Homology’s products. Because biologically sourced raw materials are subject to unique contamination risks, their use may be restricted in some countries.

In addition, ethical, social and legal concerns about gene-editing technology, gene therapy, genetic testing and genetic research could result in additional regulations restricting or prohibiting the processes Homology may use. Whether or not Homology obtains FDA approval of a product, Homology must obtain the requisite approvals from regulatory authorities in foreign countries prior to the commencement of clinical trials or marketing of the product

 

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in those countries. The requirements and process governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country. Failure to comply with applicable foreign regulatory requirements, may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

Non-clinical Studies and Clinical Trials

Similarly to the United States, the various phases of non-clinical and clinical research in the EU are subject to significant regulatory controls.

Non-clinical studies are performed to demonstrate the health or environmental safety of new chemical or biological substances. Non-clinical (pharmaco-toxicological) studies of medicinal products must be conducted in compliance with the principles of good laboratory practice, or GLP, as set forth in EU Directive 2004/10/EC (unless otherwise justified for certain particular medicinal products – e.g., radio-pharmaceutical precursors for radio-labelling purposes). Such GLP standards reflect the Organization for Economic Co-operation and Development requirements.

Clinical trials of medicinal products in the EU must be conducted in accordance with EU and national regulations and the International Conference on Harmonization, or ICH, guidelines on Good Clinical Practices, or GCP, as well as the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki. Additional GCP guidelines from the EC, focusing in particular on traceability, apply to clinical trials of advanced therapy medicinal products, or ATMPs. If the sponsor of the clinical trial is not established within the EU, it must appoint an EU entity to act as its legal representative. The sponsor must take out a clinical trial insurance policy, and in most EU member states, the sponsor is liable to provide ‘no fault’ compensation to any study subject injured in the clinical trial.

The regulatory landscape related to clinical trials in the EU has been subject to recent changes. The EU Clinical Trials Regulation, or CTR, which was adopted in April 2014 and repealed the EU Clinical Trials Directive, became applicable on January 31, 2022. Unlike directives, the CTR is directly applicable in all EU member states without the need for member states to further implement it into national law. The CTR notably harmonizes the assessment and supervision processes for clinical trials throughout the EU via a Clinical Trials Information System, which contains a centralized EU portal and database.

While the Clinical Trials Directive required a separate clinical trial application, or CTA, to be submitted in each member state in which the clinical trial was to take place, to both the competent national health authority and an independent ethics committee, much like the FDA and IRB respectively, the CTR introduces a centralized process and only requires the submission of a single application for multi-center trials. The CTR allows sponsors to make a single submission to both the competent authority and an ethics committee in each member state, leading to a single decision per member state. The CTA must include, among other things, a copy of the trial protocol and an investigational medicinal product dossier containing information about the manufacture and quality of the medicinal product under investigation. The assessment procedure of the CTA has been harmonized as well, including a joint assessment by all member states concerned, and a separate assessment by each member state with respect to specific requirements related to its own territory, including ethics rules. Each member state’s decision is communicated to the sponsor via the centralized EU portal. Once the CTA is approved, clinical study development may proceed.

The CTR provides for a three-year transition period. Clinical trials for which an application was submitted (i) prior to January 31, 2022 under the Clinical Trials Directive, or (ii) between January 31, 2022 and January 31, 2023 and for which the sponsor has opted for the application of the Clinical Trials Directive remain governed by said Clinical Trials Directive until January 31, 2025. After this date, all clinical trials (including those which are ongoing) will become subject to the provisions of the CTR.

Medicines used in clinical trials must be manufactured in accordance with Good Manufacturing Practice, or GMP. Other national and EU-wide regulatory requirements may also apply.

 

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During the development of a medicinal product, the European Medicines Agency, or EMA, and national regulators provide the opportunity for dialogue and guidance on the development program. At the EMA level, this is usually done in the form of scientific advice, which is given by the Scientific Advice Working Party of the Committee for Medicinal Products for Human Use, or CHMP. A fee is incurred with each scientific advice procedure. Advice from the EMA is typically provided based on questions concerning, for example, quality (chemistry, manufacturing and controls testing), nonclinical testing and clinical trials, and pharmacovigilance plans and risk-management programs. Advice is not legally binding with regard to any future marketing authorization application of the product concerned.

Marketing Authorization

In order to market Homology’s product candidates in the EU and many other foreign jurisdictions, Homology must obtain separate regulatory approvals. In the EU, medicinal products can only be placed on the market after obtaining a marketing authorization, or MA. The process for obtaining an MA in the EU depends, among other things, on the nature of the medicinal product. There are two types of MAs.

“Centralized MAs” are issued by the EC through the centralized procedure, based on the opinion of the EMA’s CHMP, and are valid across the entire territory of the EU. The centralized procedure is compulsory for certain types of product candidates such as: (i) medicinal products derived from biotechnology processes, such as genetic engineering, (ii) medicinal products containing a new active substance indicated for the treatment of certain diseases, such as HIV/AIDS, cancer, diabetes, neurodegenerative diseases, autoimmune and other immune dysfunctions and viral diseases, (iii) designated orphan medicines and (iv) ATMPs (i.e., gene therapy, somatic cell therapy or tissue-engineered medicines). The centralized procedure is optional for product candidates containing a new active substance not yet authorized in the EU, or for product candidates that constitute a significant therapeutic, scientific or technical innovation or which are in the interest of public health in the EU. It is very likely that the centralized procedure would apply to the products Homology is developing.

The Committee for Advanced Therapies, or CAT, is responsible in conjunction with the CHMP for the evaluation of ATMPs. The CAT is primarily responsible for the scientific evaluation of ATMPs and prepares a draft opinion on the quality, safety and efficacy of each ATMP for which a marketing authorization application, or MAA, is submitted. The CAT’s opinion is then considered by the CHMP when giving its final recommendation regarding the authorization of a product in view of the balance of benefits and risks identified. Although the CAT’s draft opinion is submitted to the CHMP for final approval, the CHMP may depart from the draft opinion, if it provides detailed scientific justification. The CHMP and CAT are also responsible for providing guidelines on ATMPs and have published numerous guidelines, including specific guidelines on gene therapies and cell therapies. These guidelines provide additional guidance on the factors that the EMA will consider in relation to the development and evaluation of ATMPs and include, among other things, the preclinical studies required to characterize ATMPs; the manufacturing and control information that should be submitted in an MAA; and post-approval measures required to monitor patients and evaluate the long-term efficacy and potential adverse reactions of ATMPs.

Under the centralized procedure, the maximum timeframe for the evaluation of an MAA by the EMA is 210 days. This excludes so-called clock stops, during which additional written or oral information is to be provided by the applicant in response to questions asked by the CHMP. At the end of the review period, the CHMP provides an opinion to the EC. If this opinion is favorable, the EC may then adopt a decision to grant an MA.

In exceptional cases, the CHMP might perform an accelerated review of an MAA in no more than 150 days (not including clock stops). Innovative products that target an unmet medical need and are expected to be of major public health interest may be eligible for a number of expedited development and review programs, such as the PRIME scheme, which provides incentives similar to the breakthrough therapy designation in the U.S. PRIME is a voluntary scheme aimed at enhancing the EMA’s support for the development of medicines that target unmet medical needs. It is based on increased interaction and early dialogue with companies developing promising medicines, to optimize their product development plans and speed up their evaluation to help them reach patients

 

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earlier. Many benefits accrue to sponsors of product candidates with PRIME designation, including but not limited to, early and proactive regulatory dialogue with the EMA, frequent discussions on clinical trial designs and other development program elements, and accelerated MAA assessment once a dossier has been submitted, but this is not guaranteed. Importantly, a dedicated contact and rapporteur from the CHMP is appointed early in the PRIME scheme facilitating increased understanding of the product at the EMA’s committee level. An initial meeting initiates these relationships and includes a team of multidisciplinary experts at the EMA to provide guidance on the overall development and regulatory strategies.

“National MAs” are issued by the competent authorities of the EU member states, only cover their respective territory, and are available for products not falling within the mandatory scope of the centralized procedure. Where a product has already been authorized for marketing in an EU member state, this national MA can be recognized in another member state through the mutual recognition procedure. If the product has not received a national MA in any member state at the time of application, it can be approved simultaneously in various member state through the decentralized procedure. Under the decentralized procedure an identical dossier is submitted to the national competent authority of each of the member states in which the MA is sought, one of which is selected by the applicant as the reference member state.

Under the above-described procedures, in order to grant the MA, the EMA or the competent authorities of the EU member states make an assessment of the risk benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy. MAs have an initial duration of five years. After these five years, the authorization may be renewed on the basis of a reevaluation of the risk-benefit balance. Once renewed, the MA is valid for an unlimited period unless the EC or the national competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal period.

Moreover, in the EU, a “conditional” MA may be granted in cases where all the required safety and efficacy data are not yet available. The conditional MA is subject to conditions to be fulfilled for generating the missing data or ensuring increased safety measures. It is valid for one year and has to be renewed annually until fulfillment of all the conditions. Once the pending studies are provided, it can become a “standard” MA. However, if the conditions are not fulfilled within the timeframe set by the EMA, the MA ceases to be renewed. Furthermore, an MA may also be granted “under exceptional circumstances” when the applicant can show that it is unable to provide comprehensive data on the efficacy and safety under normal conditions of use even after the product has been authorized and subject to specific procedures being introduced. This may arise in particular when the intended indications are very rare and, in the present state of scientific knowledge, it is not possible to provide comprehensive information, or when generating data may be contrary to generally accepted ethical principles. This MA is close to the conditional MA as it is reserved to medicinal products to be approved for severe diseases or unmet medical needs and the applicant does not hold the complete data set legally required for the grant of an MA. However, unlike the conditional MA, the applicant does not have to provide the missing data and will never have to. Although the MA “under exceptional circumstances” is granted definitively, the risk-benefit balance of the medicinal product is reviewed annually and the MA is withdrawn if the risk-benefit ratio is no longer favorable.

Advanced Therapy Classification

The EMA offers sponsors who are developing ATMPs (i.e., gene therapy, somatic cell therapy or tissue engineered medicines) a variety of benefits similar to those associated with the PRIME scheme, including scientific and regulatory guidance, additional opportunities for dialogue with regulators, and pre-submission review and certification of the chemistry, manufacturing and controls, and nonclinical data proposed for submission in a forthcoming MAA for micro-, small-, or medium-sized enterprises. Companies can consult the EMA to determine whether a medicine they are developing is an ATMP through the ATMP classification procedure.

 

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Data and Marketing Exclusivity

The EU also provides opportunities for data and market exclusivity. Upon receiving an MA, reference products generally receive eight years of data exclusivity and an additional two years of market exclusivity. If granted, the data exclusivity period prevents generic or biosimilar applicants from relying on the preclinical and clinical trial data contained in the dossier of the reference product when applying for a generic or biosimilar MA in the EU during a period of eight years from the date on which the reference product was first authorized in the EU. The market exclusivity period prevents a successful generic or biosimilar applicant from commercializing its product in the EU until 10 years have elapsed from the grant of the initial MA for the reference product in the EU. The overall ten-year market exclusivity period may be extended to a maximum of eleven years if, during the first eight years of those ten years, the MA holder obtains an authorization for one or more therapeutic indications, which, during the scientific evaluation prior to their authorization, are held to bring significant clinical benefit over existing therapies. However, there is no guarantee that a product will be considered by the EU regulatory authorities to be a new chemical or biological entity, and products may not qualify for data exclusivity.

There is a special regime for biosimilars, or biological medicinal products that are similar to a reference medicinal product but that do not meet the definition of a generic medicinal product, for example, because of differences in raw materials or manufacturing processes. For such products, the results of appropriate preclinical or clinical trials must be provided, and guidelines from the EMA detail the type and quantity of supplementary data to be provided for different types of biological product. There are no such guidelines for complex biological products, such as gene or cell therapy medicinal products, and so it is unlikely that biosimilars of those products will currently be approved in the EU. However, guidance from the EMA states that they will be considered in the future in light of the scientific knowledge and regulatory experience gained at the time.

Orphan Medicinal Products

The criteria for designating an “orphan medicinal product” in the EU are similar in principle to those in the United States. A medicinal product may be designated as orphan if its sponsor can establish that: (1) the product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition; (2) either (a) such condition affects no more than five in 10,000 persons in the EU when the application is made, or (b) the product, without the benefits derived from orphan status, would not generate sufficient return in the EU to justify the necessary investment in its development; and (3) there exists no satisfactory method of diagnosis, prevention or treatment of such condition authorized for marketing in the EU, or if such a method exists, the product will be of significant benefit to those affected by the condition.

The application for orphan designation must be submitted before the MAA. An EU orphan designation entitles a party to incentives such as reduction of fees or fee waivers, protocol assistance, and access to the centralized procedure. Upon grant of an MA, orphan medicinal products are entitled to ten years of market exclusivity for the approved therapeutic indication. During the ten-year market exclusivity period, the regulatory authorities cannot accept an MAA, or grant an MA, or accept an application to extend an MA, for the same indication, in respect of a similar medicinal product. The period of market exclusivity is extended by two years for orphan medicinal products that have also complied with an agreed pediatric investigation plan, or PIP. No extension to any supplementary protection certificate can be granted on the basis of pediatric studies for orphan indications. Orphan designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.

The 10-year orphan market exclusivity period may be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria for which it received orphan designation, for example, where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity or where the prevalence of the condition has increased above the threshold. Additionally, an MA may be granted to a similar product for the same indication at any time if (1) the second applicant can establish that its product,

 

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although similar, is safer, more effective or otherwise clinically superior to the authorized orphan product; (2) the MA holder for the authorized orphan product consents to a second orphan medicinal product application; or (3) the MA holder for the authorized orphan product cannot supply enough orphan medicinal product.

Pediatric Development

In the EU, MAAs for new medicinal products have to include the results of trials conducted in the pediatric population, in compliance with a PIP agreed with the EMA’s Pediatric Committee, or PDCO. The PIP sets out the timing and measures proposed to generate data to support a pediatric indication of the drug for which an MA is being sought. The PDCO can grant a deferral of the obligation to implement some or all of the measures of the PIP until there are sufficient data to demonstrate the efficacy and safety of the product in adults. Further, the obligation to provide pediatric clinical trial data can be waived by the PDCO when these data are not needed or appropriate because the product is likely to be ineffective or unsafe in children, the disease or condition for which the product is intended occurs only in adult populations, or when the product does not represent a significant therapeutic benefit over existing treatments for pediatric patients. Once the MA is obtained in all member states and study results are included in the product information, even when negative, the product is eligible for a six-month supplementary protection certificate, or SPC, extension (provided an application for such extension is made at the same time as filing the SPC application for the product, or at any point up to two years before the SPC expires) or, in the case of orphan pharmaceutical products, a two year extension of the orphan market exclusivity is granted (as described above).

Post-Approval Requirements

Similar to the United States, both MA holders and manufacturers of medicinal products are subject to comprehensive regulatory oversight by the EMA, the EC and/or the competent regulatory authorities of the member states. The holder of an MA must establish and maintain a pharmacovigilance system and appoint an individual qualified person for pharmacovigilance, or QPPV, who is responsible for the establishment and maintenance of that system, and oversees the safety profiles of medicinal products and any emerging safety concerns. Key obligations include expedited reporting of suspected serious adverse reactions and submission of periodic safety update reports, or PSURs.

All new MAAs must include a risk management plan, or RMP, describing the risk management system that the company will put in place and documenting measures to prevent or minimize the risks associated with the product. The regulatory authorities may also impose specific obligations as a condition of the MA. Such risk-minimization measures or post-authorization obligations may include additional safety monitoring, more frequent submission of PSURs, or the conduct of additional clinical trials or post-authorization safety studies.

The advertising and promotion of medicinal products is also subject to laws concerning promotion of medicinal products, interactions with physicians, misleading and comparative advertising and unfair commercial practices. All advertising and promotional activities for the product must be consistent with the approved summary of product characteristics, and therefore all off-label promotion is prohibited. Direct-to-consumer advertising of prescription medicines is also prohibited in the EU. Although general requirements for advertising and promotion of medicinal products are established under EU directives, the details are governed by regulations in each member state and can differ from one country to another.

Failure to comply with EU and member state laws that apply to the conduct of clinical trials, manufacturing approval, MA of medicinal products and marketing of such products, both before and after grant of the MA, manufacturing of pharmaceutical products, statutory health insurance, bribery and anti-corruption or with other applicable regulatory requirements may result in administrative, civil or criminal penalties. These penalties could include delays or refusal to authorize the conduct of clinical trials, or to grant an MA, product withdrawals and recalls, product seizures, suspension, withdrawal or variation of the MA, total or partial suspension of production, distribution, manufacturing or clinical trials, operating restrictions, injunctions, suspension of licenses, fines and criminal penalties.

 

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The aforementioned EU rules are generally applicable in the European Economic Area, or EEA, which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland.

UK-specific requirements

Since the end of the Brexit transition period on January 1, 2021, Great Britain (England, Scotland and Wales) has not been directly subject to EU laws, however under the terms of the Ireland/Northern Ireland Protocol, EU laws generally apply to Northern Ireland. The EU laws that have been transposed into United Kingdom law through secondary legislation remain applicable in Great Britain. However, under the Retained EU Law (Revocation and Reform) Bill 2022, which is currently before the UK parliament, any retained EU law not expressly preserved and “assimilated” into domestic law or extended by ministerial regulations (to no later than June 23, 2026) will automatically expire and be revoked by December 31, 2023. Legislation which came into force after the expiry of the Brexit transition period, such as the EU CTR, is not applicable in Great Britain, or GB .

Under the Medicines and Medical Devices Act 2021, the Secretary of State or an ‘appropriate authority’ has delegated powers to amend or supplement existing regulations in the area of medicinal products and medical devices. This allows new rules to be introduced in the future by way of secondary legislation, which aims to allow flexibility in addressing regulatory gaps and future changes in the fields of human medicines, clinical trials and medical devices.

Since January 1, 2021, the Medicines and Healthcare products Regulatory Agency, or MHRA, has been the UK’s standalone medicines and medical devices regulator. As a result of the Northern Ireland Protocol, Northern Ireland will continue to follow the EU regulatory regime, but its national competent authority will remain the MHRA.

The MHRA has introduced changes to national licensing procedures, including procedures to prioritize access to new medicines that will benefit patients, including a 150-day assessment and a rolling review procedure. All existing EU MAs for centrally authorized products were automatically converted or grandfathered into UK MAs, effective in GB (only), free of charge on January 1, 2021, unless the MA holder opted-out. In order to use the centralized procedure to obtain an MA that will be valid throughout the EEA, companies must be established in the EEA. Therefore since Brexit, companies established in the UK can no longer use the EU centralized procedure and instead an EEA entity must hold any centralized MAs. Until January 1, 2024, the MHRA may rely on a decision taken by the EC on the approval of a new MA in the centralized procedure, in order to more quickly grant a new GB MA. A new international recognition framework will be put in place from January 1, 2024, whereby the MHRA will have regard to decisions on the approval of MAs made by the EMA and certain other regulators when determining an application for a new GB MA.

There is now no pre-MA orphan designation in GB. Instead, the MHRA reviews applications for orphan designation in parallel to the corresponding MA application. The criteria are essentially the same, but have been tailored for the market, i.e., the prevalence of the condition in GB, rather than the EU, must not be more than five in 10,000. Should an orphan designation be granted, the period or market exclusivity will be set from the date of first approval of the product in GB.

The UK regulatory framework in relation to clinical trials is derived from the previous EU Clinical Trials Directive (as implemented into UK law, through secondary legislation). On January 17, 2022, the MHRA launched an eight-week consultation on reframing the UK legislation for clinical trials. The consultation closed on March 14, 2022 and aims to streamline clinical trials approvals, enable innovation, enhance clinical trials transparency, enable greater risk proportionality, and promote patient and public involvement in clinical trials. The outcome of the consultation is being closely watched and will determine whether the UK chooses to align with the CTR or diverge from it to maintain regulatory flexibility.

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new framework fundamentally changes the existing system under the Northern Ireland Protocol, including with respect to the regulation of medicinal products in the UK. In particular, the MHRA will be responsible for approving all medicinal products destined for the UK market (i.e., GB and Northern Ireland), and the EMA will no longer have any role in approving medicinal products destined for Northern Ireland. A single UK-wide MA will be granted by the MHRA for all medicinal products to be sold in the UK, enabling products to be sold in a single pack and under a single authorization throughout the UK. The Windsor Framework was approved by the European Union-United Kingdom Joint Committee on March 24, 2023, so the UK government and the EU will enact legislative measures to bring it into law. On June 9, 2023, the MHRA announced that the medicines aspects of the Windsor Framework will apply from January 1, 2025.

If Homology fails to comply with applicable foreign regulatory requirements, it may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

Employees and Human Capital

As November 30, 2023, Homology had 7 full-time employees, including one employee with a M.D. or Ph.D. degree. None of Homology’s employees is represented by a labor union or covered by a collective bargaining agreement. Homology considers its relationships with its employees to be good.

Homology’s Corporate Information

Homology was incorporated in Delaware in March 2015. Homology’s principal executive offices are located at One Patriots Park, Bedford, MA 01730 and its telephone number is (781) 327-2633. Homology’s website address is www.homologymedicines.com. Information contained on or accessible through Homology’s website is not a part of this proxy statement/prospectus, and the inclusion of Homology’s website address in this proxy statement/prospectus is an inactive textual reference only.

Properties

Homology currently occupies approximately 26,850 square feet of office and research and development laboratory space in Bedford, Massachusetts, under a sublease agreement with OXB Solutions that is scheduled to expire in 2024. Homology believes that its facilities are sufficient to meet its current needs and that suitable additional space will be available as and when needed.

Legal Proceedings

From time to time, Homology may become involved in litigation relating to claims arising from the ordinary course of business. Homology’s management believes that there are currently no claims or actions pending against it, the ultimate disposition of which could have a material adverse effect on Homology’s results of operations or financial condition.

On March 25, 2022, a stockholder of Homology, Michael C. Pizzuto, filed a putative class action complaint alleging violations of Sections 10(b) and 20(a) of the Securities and Exchange Act of 1934, as amended, against Homology and certain of its executives. Pizzuto v. Homology Medicines, Inc., No. 2:22– CV – 01968 (C.D. Cal 2022). The complaint alleges that Homology failed to disclose certain information regarding efficacy and safety in connection with a Phase I/II HMI-102 clinical trial, and seeks damages in an unspecified amount. The case is in its early stages. Homology believes the claims alleged lack merit and has filed a motion to transfer venue (filed September 2, 2022) and a motion to dismiss (filed October 17, 2022). On April 18, 2023, the court granted the motion to transfer, finding that venue was not proper in the Central District of California and transferring the case to the District of Massachusetts. Following the transfer, the case number changed to 1:23-cv-10858-AK (D. Mass.). On May 9, 2023, the Massachusetts court issued an order permitting the parties to submit updated

 

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briefs in connection with the motion to dismiss, which were submitted on June 8, 2023, July 13, 2023, and August 3, 2023. The motion to dismiss remains pending. As the outcome is not presently determinable, any loss is neither probable nor reasonably estimable.

 

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Q32’S BUSINESS

Overview

Q32 is a clinical stage biotechnology company focused on developing novel biologics to effectively and safely restore healthy immune balance in patients with autoimmune and inflammatory diseases driven by pathological immune dysfunction. To achieve the goal of restoring homeostasis to a dysregulated immune system, Q32 is advancing antibody-based therapeutic candidates designed to target two central pathways of adaptive and innate immunity. The adaptive immune system is largely composed of T- and B-cell mediated cellular and antibody responses, while the innate immune system is the body’s first line of defense employing leukocytes that are responsible for clearing pathogens and cellular debris and modulating T- and B-cell function. Q32 believes that targeting these key pathways of immune dysregulation in autoimmune and inflammatory diseases will deliver therapeutics for indications with clear unmet medical need in the near term, while enabling it to build a broad and diverse pipeline in the long term. Q32 has multiple product candidates across a variety of autoimmune and inflammatory diseases with clinical readouts for Q32’s two lead programs expected in 2024 and 2025.

Bempikibart (ADX-914), Q32’s most advanced product candidate, is a fully human anti–interleukin-7 receptor alpha, or IL-7Rα, antagonist monoclonal antibody designed to re-regulate adaptive immune function by blocking signaling mediated by interleukin-7, or IL-7, and thymic stromal lymphopoietin, or TSLP. Bempikibart is being studied in two double-blind, placebo-controlled Phase 2 clinical trials designed to establish proof of clinical concept and evaluate Q32’s selected Phase 2 dose. One trial is evaluating the use of bempikibart for the treatment of atopic dermatitis, or AD, and one is evaluating bempikibart for the treatment of alopecia areata, or AA. Enrollment in both clinical trials remains ongoing and Q32 expects to report topline data from both Phase 2 clinical trials in the second half of 2024.

ADX-097, the lead product candidate from Q32’s complement inhibitor platform, is a humanized anti-C3d monoclonal antibody, or mAb, fusion protein. ADX-097 is designed to restore complement regulation—an integral part of the innate immune system—through a tissue-targeted mechanism. ADX-097 is designed to inhibit alternative pathway complement activation locally in diseased tissues where complement-mediated pathology is actively manifest. Q32 believes ADX-097 has the potential to drive improved clinical activity and address the limitations of the currently available systemic approaches to complement inhibition, including infection risk and the need for high drug doses and frequent administration, to achieve therapeutic levels of inhibition. Q32 is developing ADX-097 for the treatment of renal and other complement-mediated diseases of high unmet need, including lupus nephritis, or LN, immunoglobulin A, or IgA, nephropathy, or IgAN, complement component 3 glomerulopathy, or C3G, and anti-neutrophil cytoplasmic antibody, or ANCA, associated vasculitis, or AAV. Q32 has completed dosing of healthy volunteers in a Phase 1 trial of ADX-097. Q32 expects to initiate an open-label Phase 2 renal basket program in the first half of 2024, with initial data expected by year-end 2024, and initiate a Phase 2 clinical trial in AAV, with topline data from both the renal basket and AAV trials anticipated in the second half of 2025.

In addition to ADX-097, Q32 is also engaged in additional pipeline efforts to expand therapeutic opportunities within complement-mediated diseases.

 

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Q32’s development pipeline is shown in the figure below.

Figure 16: Q32’s Development Pipeline

 

LOGO

Note: AAV = Anti-Neutrophil Cytoplasmic Autoantibody (ANCA)-Associated Vasculitis; IgAN = IgA Nephropathy; LN = Lupus Nephritis; C3G = C3 Glomerulopathy. (1) Regained full development and commercial rights in November 2023.

Bempikibart (ADX-914)

Q32’s most advanced product candidate, bempikibart, is a fully human antibody anticipated to block IL-7- and TSLP-mediated signaling via their cognate receptors. Increased levels of IL-7 and TSLP are associated with inflammatory and autoimmune diseases.

In October 2023, Amgen, Inc., or Amgen, completed the acquisition of Horizon Therapeutics public limited company, or Horizon plc. Following its acquisition of Horizon plc, Q32 agreed with Amgen to mutually terminate the Collaboration and Option Agreement, or the Horizon Collaboration Agreement, and the Asset Purchase Agreement, or the Purchase Agreement, and together with the Horizon Collaboration Agreement, the Horizon Agreements, each between Q32 and Horizon Therapeutics Ireland DAC, or Horizon. In November 2023, Q32 and Horizon entered into a termination agreement, or the Horizon Termination Agreement, pursuant to which Horizon’s option to acquire the bempikibart program was terminated. As a result, Q32 retained the initial consideration and development funding received under the Horizon Collaboration Agreement and regained full development and commercial rights to bempikibart. In consideration for the Horizon Termination Agreement, Q32 agreed to pay Horizon regulatory and sales milestones payments of up to an aggregate amount of $75.1 million upon the first achievement of certain regulatory and sales milestones with respect to bempikibart. For more information see the section titled “Q32’s Business—Collaboration and License Agreements.”

Q32 has completed a Phase 1 study that showed bempikibart was well tolerated and exhibited a pharmacokinetics, or PK, / pharmacodynamic, or PD, profile supporting dosing of no more frequently than once every two weeks. There were no severe or serious adverse events, or AEs, reported and there was no impact of any observed anti-drug antibodies, or ADAs, on pharmacology or safety. Q32 is currently conducting two Phase 2 clinical trials, one in each of AA and AD, with topline data for both clinical trials expected in the second half of 2024.

T cell pathology has been strongly implicated in AD and AA. Accumulating evidence suggests that multiple pathways are important in the pathogenesis of AD. This emerging view supports the belief that novel therapeutics, such as bempikibart, that more specifically address the underlying immune-phenotypic progression of the disease are needed. TH1 has long been implicated in the pathogenesis of AA supporting the potential for bempikibart to

 

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directly address the underlying driver of follicle damage and hair loss. In addition, given that AA is a disease often diagnosed in young adults, there is a critical need for effective novel treatments with a safety profile suitable for long-term, chronic treatment.

Q32 owns and has in-licensed various patents, patent applications, know-how and trade secrets relating to the development and commercialization of Q32’s IL-7Rα -targeted antagonistic antibody therapy candidates and platform technologies. Patents that have issued or may issue in the future protect composition of the bempikibart product candidate to the beginning of 2040, and protect methods of use to 2044, excluding any patent term adjustments and/or any patent term extensions.

ADX-097

ADX-097 is an anti-C3d antibody linked to two moieties of a fragment of human factor H, or fH. C3d is a ubiquitous marker of complement activation, located adjacent to C3 convertase complexes. Factor H is an important negative regulator of the complement alternative pathway, or AP. While complement can be activated through three pathways, the AP is central to all because it amplifies signaling. This aspect of AP activation is commonly known as the “amplification loop” and is responsible for much of the damage observed in complement-mediated diseases.

Q32 has evaluated ADX-097 in a Phase 1 clinical trial in healthy volunteers where Q32 observed circulating PK/PD consistent with preclinical studies, which established in vivo ADX-097 integrity and informed Q32’s dosing strategy for next stage clinical testing. In addition, no severe or serious AEs were reported and minimal ADAs were observed in this Phase 1 clinical trial.

These Phase 1 data and Q32’s preclinical studies have enabled targeted indication selection for Q32’s Phase 2 program as well as informed Q32’s key Phase 2 dose. Q32 expects to initiate an open-label Phase 2 renal basket program in the first half of 2024 and a Phase 2 clinical trial in AAV in the first half of 2025.

In complement mediated proteinuric renal diseases (e.g., LN, IgAN and C3G), there remains substantial unmet need for therapeutics that can more effectively mitigate proteinuria and improve long-term kidney outcomes. Additionally, in AAV, even with optimal treatment, successful attainment and long-term maintenance of remission remains challenging and the therapeutics used as part of standard of care, or SOC, treatment are themselves associated with significant infection related morbidity. Q32 believes that the tissue-directed approach to addressing complement dysregulation has the potential to drive improved efficacy and better safety across these indications. This tissue directed AP approach also has the potential to avoid the additive infection risk associated with systemic complement treatments, which is of significant importance to patients where the underlying condition is marked by high mortality due to infection (e.g., LN and AAV).

Complement activation is an essential part of innate and humoral immunity, and uncontrolled and sustained tissue complement activity plays a significant role in the pathogenesis of multiple human inflammatory and autoimmune diseases. The first approved complement inhibitor, eculizumab, targets C5 systemically, one of the effector arms of the complement pathway. The next generation of marketed and development stage complement therapeutics continue to rely on systemic complement blockade. To date, eight complement inhibitors have been approved for various indications with cumulative sales of nearly $6 billion in 2022. While commercial and clinical success provide validation of complement as a therapeutic target, clinical experience reveals the inherent drawbacks of systemic inhibition as a therapeutic approach, including:

 

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limited activity due to reliance on systemic blockade for control of complement dysregulation at the tissue level;

 

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high treatment burden, including high doses and/or frequent administration due to high abundance and rapid turnover of most target complement proteins; and

 

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infection risk due to systemic blockade.

 

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Q32’s aim is to solve for these inherent drawbacks with Q32’s proprietary approach designed to generate tissue targeted inhibitors of complement activation, which have the following advantages:

 

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enhanced activity through tissue targeted inactivation of convertases directly at the site of destruction;

 

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convenient dosing with a subcutaneous route and weekly dosing, with potential for every 2 week dosing; and

 

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improved risk/benefit profile by maximizing therapeutic index while maintaining intact systemic immune surveillance.

Q32 owns various patents, patent applications, know-how and trade secrets relating to the development and commercialization of Q32’s targeted complement inhibitor candidates and platform technologies. Patents that have issued or may issue in the future protect composition of the ADX-097 complement product candidate to the end of 2039, and protect methods of use to the end of 2044, excluding any patent term adjustments and/or any patent term extensions.

Q32’s Team

Q32 has assembled a team of industry-leading research, drug development, and operational experts, who have deep experience in advancing drug candidates in autoimmune and inflammatory diseases. The team is led by Jodie Morrison, Q32’s Chief Executive Officer, who brings extensive biopharma leadership experience from early stage through mid-size public biotech and pharmaceutical companies; Shelia Violette, Ph.D. Founder, Chief Scientific Officer and President of Research, has more than 30 years of biotech experience in inflammatory and autoimmune diseases and served as an Entrepreneur in Residence at Atlas Venture; Jason Campagna, M.D., Ph.D., Chief Medical Officer, has more than 15 years of experience advancing all stages of clinical development pipelines; Lee Kalowski, interim Chief Financial Officer, has 20 years of life science industry experience and has previously served as CFO at multiple biotech companies and in equity research; and Saul Fink, Ph.D., Chief Technical Officer, has extensive experience in leading manufacturing and nonclinical development of small molecules and biologics.

Q32 was built upon the discoveries and findings from renowned researchers in immunology: Michael Holers, M.D. and Joshua Thurman, M.D., from the University of Colorado and Stephen Tomlinson, Ph.D. from the Medical University of South Carolina. They are pioneers in the field of tissue targeted regulation of complement system.

Q32 is supported by leading biotechnology investors and pharmaceutical companies including OrbiMed, Atlas Venture, Abingworth, BMS, Acorn Bioventures, Osage University Partners, CU Healthcare Innovation Fund and Sanofi Ventures.

Q32’s Strategy

Q32’s mission is to develop therapeutics that restore healthy immune regulation for patients with severe autoimmune and inflammatory diseases. Q32’s strategic initiatives are to:

 

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Complete Q32’s Phase 2 AD trial with bempikibart. Q32 plans to complete the ongoing Phase 2 clinical trial for bempikibart in AD with topline results expected in the second half of 2024.

 

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Complete Q32’s Phase 2 AA trial with bempikibart. Q32 plans to complete the ongoing Phase 2 clinical trial for bempikibart in AA with topline results expected in the second half of 2024.

 

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Complete a renal basket program with ADX-097. Subject to regulatory clearance, Q32 plans to initiate a renal basket program in the first half of 2024 with initial data expected by year-end 2024.

 

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Complete Part A of Q32’s Phase 2 AAV trial with ADX-097. Q32 plans to initiate Part A of Q32’s Phase 2 AAV trial in the first half of 2025 with topline results expected in the second half of 2025.

 

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Leverage Q32’s deep expertise in tissue targeted complement therapeutic development to build a broad portfolio. Q32 is engaged in research activities to advance Q32’s pipeline of additional candidates targeting complement inhibition.

 

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Q32’s Programs

Bempikibart in AD and AA

Bempikibart blocks both IL-7 and TSLP cytokine signaling pathways. IL-7 lowers the threshold needed for T cells to respond in low antigen microenvironments promoting pathogenic T-effector cell function, induces TH2 cell-mediated antibody production, and inhibits the immunosuppressive properties of T regulatory cells. When uncontrolled, IL-7 can promote inflammation and autoimmune disease. By blocking IL-7 signaling, Q32 believes bempikibart has the potential to re-regulate immunity by rebalancing the T-effector / T-regulatory ratio to inhibit inflammation and invoke tolerance, and mitigating T-cell dependent autoantibody responses. TSLP is a cytokine that promotes TH2 cell differentiation and production of TH2 cytokines, such as IL-4, IL-5, and IL-13, and promotes inflammation, particularly at the epidermis, in response to environmental stimuli. IL-7 and TSLP signaling have been biologically linked to numerous inflammatory and autoimmune diseases including Q32’s initial target diseases of AD and AA. The figures below illustrate the mechanistic rationale for bempikibart in AD and AA.

Figure 17: Bempikibart Has the Potential to Modulate Immune Cells Important in Both Acute and Chronic AD Pathogenesis

 

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Figure 18: Bempikibart Has the Potential to Block TH1-and TH2-Driven Disease Pathology in AA

 

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In October 2023, Amgen, Inc., or Amgen, completed the acquisition of Horizon plc. Following its acquisition of Horizon plc, Q32 agreed with Amgen to mutually terminate the Horizon Agreements. In November 2023, Q32 and Horizon entered into the Horizon Termination Agreement pursuant to which Horizon’s option to acquire the bempikibart program was terminated. As a result, Q32 retained the initial consideration and development funding received under the Horizon Collaboration Agreement and regained full development and commercial rights to bempikibart. In consideration for the Horizon Termination Agreement, Q32 agreed to pay Horizon regulatory and sales milestones payments of up to an aggregate amount of $75.1 million upon the first achievement of certain regulatory and sales milestones with respect to bempikibart. For more information, see the section titled “Q32’s Business—Collaboration and License Agreements.”

Bempikibart Preclinical and Clinical Data

Bempikibart was evaluated in a series of in vitro assays and demonstrated potent inhibition of IL-7-and TSLP-mediated intracellular signaling.

Bempikibart, or a mouse surrogate, SB14, was evaluated in vivo in animal models of inflammation and autoimmunity. Activity was observed as determined by various endpoints, including disease activity measures, body weight, inflammatory cytokine production and tissue damage.

 

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Preclinical studies evaluating bempikibart PK, PD and toxicology were carried out in non-Good Laboratory Practice, or GLP, single dose and GLP repeat dose studies of 6 weeks, 3-months, and 6-months duration in cynomolgus monkeys. Bempikibart exposure was maintained above the desired PK threshold throughout the dosing phase in most animals despite detectable ADAs. PD evaluations included T cell receptor occupancy, or RO, inhibition of IL-7–induced phosphorylation of STAT5, or pSTAT5, an immediate proximal marker of IL-7R intracellular signaling, and keyhole limpet hemocyanin, or KLH-induced T cell dependent antibody response. There was a favorable PK/PD relationship, with bempikibart demonstrating >95% RO, ≥90% inhibition of pSTAT5 and up to 80% suppression of a KLH-induced IgG response.

Bempikibart was generally well tolerated in all preclinical studies described above. The no-observed-adverse-effect level, or NOAEL, in the 6-month GLP study was 150 mg/kg, the highest dose tested, with exposure >50x the anticipated area under the curve at the dose presently being utilized for the ongoing Phase 2 studies.

Phase 1 Clinical Trial Results

Q32 has completed a Phase 1 study, ADX-914-001, to assess the safety, PK, and PD of bempikibart after subcutaneous, or SC, administration in healthy volunteers. Pharmacodynamic analyses showed bempikibart treatment at doses achieving ≥95% RO demonstrated >90% inhibition of pSTAT5. Doses of bempikibart as low as 0.3mg/kg achieved full RO and pSTAT5 inhibition over a period of up to 48 hours; doses greater than 1 mg/kg demonstrated sustained full RO for at least 2 weeks. In addition, analysis of overall numbers of lymphocytes and lymphocyte subsets demonstrated modest, dose-dependent effects consistent with the expected and desired bempikibart pharmacology.

Safety data showed that bempikibart demonstrated a favorable safety profile at single doses up to 4 mg/kg and repeat doses of 1 mg/kg every 2 weeks in healthy subjects. There were no safety-related treatment discontinuations, no serious or severe AEs reported, and no deaths.

See the Figure 19 for a summary of the data from Q32’s Phase 1 clinical trial of bempikibart.

Figure 19: Bempikibart Phase 1 Clinical Data Support Clinical Development

 

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RO: Receptor occupancy; pSTAT5: phosphorylated STAT5; Q2W: once every 2 weeks; MAD: multiple ascending dose; NHV: normal healthy volunteers; SAD: single ascending dose; SC: subcutaneous; Teff: T effector; Treg: T regulatory; ADA: anti-drug antibody; Ab: antibody

 

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Pharmacology Sub-study in Patients with AD

Study ADX-914-202 is an ongoing, two-part, Phase 2, randomized, double-blind, placebo-controlled, proof-of-concept study in adult subjects with persistent moderate to severe AD, consisting of Part A and Part B. Part A evaluated PK/PD, as well as preliminary efficacy and tolerability, to support dose selection for Part B, which is evaluating the efficacy of bempikibart in AD, as well as for ADX-914-203, a trial evaluating the safety, efficacy, and dose selection of bempikibart in AA. To date, bempikibart has been generally well tolerated, with no notable safety findings (see figure below for a summary of this interim blinded data from Part A). Based on data from both ADX-914-001 and Part A of ADX-914-202, a dose of 200 mg administered subcutaneously every two weeks has been selected as the Phase 2 dose for both Part B of ADX-914-202 and for ADX-914-203 and enrollment in both trials is ongoing. Figure 20 shows PK data from Part A of ADX-914-202, which supports the ongoing development program.

Figure 20: Bempikibart Phase 2 AD Part A PK Data

 

 

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The Role of IL-7 and TSLP in AD and AA

AD

There is evidence for the involvement of IL-7 and its actions on T cells in the pathobiology underlying AD. IL-7–overexpressing mice spontaneously develop chronic dermatitis and show an increased number of lymphocytes in skin. There is a growing body of evidence from mouse, non-human primates, or NHPs, and man on the importance of tissue-resident memory cells, or TRMs, in skin inflammatory disorders, including AD.

TSLP is also strongly implicated in the pathogenesis of AD and this cytokine is highly expressed in AD skin lesions. TSLP plays a role in activating group 2 innate lymphoid cells, which are enriched in the skin of patients with AD. In rodent models of disease, attenuation of TSLP signaling leads to improvement in keratosis, acanthosis, and dermal mononuclear cell infiltration.

Rationale for Dual IL7-R/TSLP-R Inhibition in AD

Early AD is characterized by activation of the skin innate immune response alongside a core Th2-T helper cell adaptive response. Later in the disease, a widening of the adaptive immunity is evident with Th1, Th17, and Th22 responses becoming more relevant. Within this framework, TSLP and IL-7 may act as sequential mediators of AD initiation (via Th2 pathways) and progression (via Th1 and/or Th17), respectively (see figure 17 above).

 

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Dual IL-7/TSLP blockade with bempikibart could represent an important therapeutic modality considering the evolving understanding of the immunopathology underlying AD in humans.

AA

AA is an immune-mediated disorder that results in hair loss and shares some similarity in pathophysiology with AD. Studies have indicated that multiple immunomodulators are involved in the development of AA, with hair follicle immune privilege collapse being a key marker in the course of the disease. Immune system activation in lesional skin contributes to the progression of disease.

IL-7 has been shown to be involved in the pathogenesis of AA. IL-7 expression is upregulated at the site of AA lesions and animal studies demonstrated IL-7–dependent acceleration of disease progression and beneficial effects with IL-7Rα inhibition. Cumulatively, substantial evidence suggests that inhibition of IL-7Rα may be an effective modulator of the T-cell response that could act to reverse alopecia.

Current Treatment Landscape and Unmet Need in AD and AA

AD is the most common chronic inflammatory skin disease. The majority of AD starts in infancy or childhood, with the remaining disease burden developing during adulthood. The prevalence in children varies from 2.7% to 20.1% by geography and ranges from 2.1% to 4.9% in adults. The disease is heterogeneous in its natural history, and individual trajectories are variable.

Historically, the main therapeutic approaches have included avoidance of triggers, paired with the use of topical agents that are intended to exert local control of skin lesions and/or itch, and broad-spectrum immunosuppressive agents for more severe or high surface area disease. Many of these commonly used treatments have provided limited improvements in affected total body surface, severity of disease for any given body area involvement and/or resolution in itch varying among treated populations, and potentially not all have been achieved in the same patient. Approved topical therapeutics have also been associated with substantial safety concerns. For example, topical calcineurin inhibitors including tacrolimus and pimecrolimus, both of which carry boxed warnings for potential safety risks, including skin cancers and lymphomas.

More recently, systemic, targeted, immunomodulating biologics have been approved for use in AD. The anti–IL-4Rα antibody dupilumab, which inhibits IL-4 and IL-13 signaling (and obtained U.S. approval in 2016 and European Union, or EU, approval in 2017), was the first systemic biologic to become available for the treatment of patients with AD. The small-molecule Janus kinase, or JAK, inhibitors baricitinib (EU 2020 approval date), upadacitinib and abrocitinib (US 2021 approval dates) and the anti–IL-13 antibody tralokinumab (US 2021 approval date) have also been approved for use in AD. Despite these recent approvals, these therapeutics either narrowly address only partial elements of the disease biology or are associated with potential serious, long-term safety concerns, thus there remains a continued unmet medical need. Ideally, disease management evolves to account for the clinical, and likely biologic, heterogeneity characteristic of the disease.

AA is an autoimmune condition that affects hair follicles and leads to hair loss. This condition may develop at any age and in both sexes, and the incidence of this disease has been estimated to be 2% of the population worldwide. The disease most commonly affects scalp and facial hair and although some patients recover spontaneously, many patients progress to alopecia totalis (total scalp hair loss) or alopecia universalis (total body hair loss). The disease is associated with significant quality of life impairment and is associated with a high burden of psychosocial comorbidities, such as depression. Although pathophysiology has not been fully delineated, development of the condition is mediated by inflammatory mechanisms, and it is thought to have genetic and environmental components. IL-7 upregulation has been shown to be involved in the pathogenesis of AA, and evidence suggests that inhibition of IL-7Rα may be an effective modulator of the T-cell response driving injury in the disease.

Baricitinib and ritlecitinib, both JAK inhibitors, are the only current FDA-approved treatments for AA. Although JAK inhibitors have demonstrated hair regrowth in patients with severe disease (≥50% hair loss),

 

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increased risk of serious side effects may preclude this option for some patient populations. Other standard-of-care approaches for alopecia include topical corticosteroids, immunotherapy, and light therapy. Because hair loss can affect such disparate body locations, these treatments often have limited usefulness across the patient population.

Further Clinical Development of Bempikibart: Clinical Trial Plan

For patients with a wide range of autoimmune diseases, including AD and AA, Q32 believes the blockade of IL-7 and/or TSLP signaling may offer a new therapeutic approach to modulate the autoimmune response. A high unmet medical need exists for more broadly effective therapies in these conditions, and Q32 is developing bempikibart with the goal of addressing this need. Based on the totality of data to date, bempikibart has shown a favorable safety profile and has not been associated with clinically meaningful ADA. At exposures that can be achieved via SC administration, bempikibart has shown full receptor occupancy and signaling inhibition.

Overall, the available clinical and nonclinical data for bempikibart support the continued clinical development of bempikibart. To this end, Q32 has advanced bempikibart into two ongoing Phase 2 studies, ADX-914-202 (AD) and ADX-914-203 (AA).

Study ADX-914-202

This is an ongoing, two-part, Phase 2, proof-of-concept study in adults with persistent moderate to severe disease as defined by the EASI score. Part A is the PK/PD run-in portion of the study and was conducted to inform dose selection for the subsequent Part B portion and for the Phase 2 study in AA. Bempikibart or placebo will be dosed SC every two weeks for 12 weeks, with a follow-up period of 12 weeks.

 

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The study will recruit adults with chronic AD who have moderate to severe disease activity at the time of consent and who, in the opinion of the Investigator, have a history of inadequate response to previous therapy. In total, approximately 110 subjects will be enrolled.

 

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The primary objective of Part A is to identify the recommended bempikibart dose for Part B. Q32 conducted an interim analysis to review the preliminary PK and safety data from Part A, and 200 mg was selected as the recommended Phase 2 dose for Part B.

 

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The primary objective of Part B is to evaluate the efficacy of bempikibart vs placebo. The primary endpoint of Part B is the mean percentage change from Baseline in EASI score at Week 14 for bempikibart (200 mg) vs placebo.

Study ADX-914-203

Study ADX-914-203 is an ongoing Phase 2 proof-of-concept trial to assess the efficacy, safety, and tolerability of bempikibart in participants with severe AA, as defined by the SALT score. In the study, bempikibart or placebo will be dosed SC for 24 weeks, with a follow-up period of 12 weeks.

 

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The study will recruit adults with a current episode of severe hair loss with no spontaneous improvement over the past 6 months, along with the Investigator’s assessment that hair loss has been stable for at least 3 months and regrowth is possible.

 

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Approximately 40 participants will be enrolled and randomly assigned (3:1) to receive 200 mg bempikibart or matching placebo administered SC every two weeks for 24 weeks. The primary efficacy endpoint is the mean relative percent change in SALT score at 24 weeks compared with baseline.

ADX-097 in LN, IgAN, C3G and AAV

Complement is an integral part of the innate immune system used as a first line of defense for removing bacteria and other pathogens, as well as damaged cells, and for modulating an adaptive immune response. In spite of these beneficial functions, when the complement system becomes dysregulated it can be a critical driver of chronic inflammatory and autoimmune diseases.

 

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There are three main branches of the complement system: the classical, or CP, the lectin, or LP, and the AP. These pathways can lead to the generation of cellular/tissue bound protein complexes, called convertases, the gatekeepers that catalyze the cleavage of the complement component 3 and 5 proteins, or C3 and C5, respectively. This cleavage, predominantly happening on the cellular/tissue surface, ultimately leads to the formation of C3a and C5a, chemotactic factors that recruit inflammatory immune cells, and the assembly of C5b-9 forming the membrane attack complex, or MAC, on cell membranes. Uncontrolled and persistent production of these complement activation products ultimately leads to pathological tissue inflammation and cellular damage.

The AP is central to the complement system. It provides for amplification of complement signaling downstream of all 3 complement pathways, commonly referred to as the “amplification loop” (see figure below). Consequently, sustained overactivation of the complement system in many diseases is driven by AP activation.

Figure 21: Schematic of the Complement System Showing Critical Elements of the Three Pathways.

 

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MAC: Membrane attack complex.

Under normal conditions, inactivation of convertases, to maintain proper balance of the complement system, is endogenously controlled by several complement negative regulatory proteins. Among these is fH, a protein that binds and inactivates AP convertases. Factor H both catalyzes dissociation of AP C3 and C5 convertases and, in combination with Factor I, leads to irreversible catalytic degradation.

Given the central role of the AP in driving complement activity, gaining control of this pathway provides a mechanism to restore proper regulation of the complement system when it becomes dysregulated in disease.

ADX-097

ADX-097 is a C3d mAb recombinantly linked to 2 moieties of human fH1-5. ADX-097 was designed to provide a unique tissue targeted therapeutic approach to restore proper complement regulation on the surfaces of cells in diseased tissue where AP convertase assembly occurs and the amplification loop magnifies complement activation. The fH1-5 component of ADX-097 consists of the first five N-terminal domains of fH, which catalyzes the dissociation and irreversible proteolytic degradation of the AP C3/C5 convertases. When C3 is cleaved as a

 

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consequence of complement activation it leads to the generation of high-density surface bound C3d deposits positioned adjacent to the AP C3/C5 convertases. Q32’s preclinical studies demonstrate that the binding of the antibody portion of ADX-097 to C3d brings the human fH1-5 protein into proximity with surface-bound C3/C5 AP convertases, allowing fH1-5 to interrupt complement activation. Thus, Q32 believes, based on preclinical studies, that ADX-097 has the potential to durably restore control of the complement system at specific sites of ongoing injury and at doses where complement surveillance is maintained in circulation. See Figure 22 for a depiction of ADX-097’s targeted mechanism of action.

Figure 22: Schematic of ADX-097 Targeted Mechanism of Action

 

 

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fH1-5: first 5 N-terminal short consensus repeats of human factor H; mAb: monoclonal antibody

Given the ubiquitous nature of C3d deposition in tissue where complement is activated, and the importance of the AP in maintaining complement activation, Q32 believes ADX-097 has therapeutic potential for multiple diseases. Q32 also believes that by inhibiting complement in a tissue-directed manner, a greater potential for clinical activity is possible, particularly in Q32’s renal basket program and AAV Phase 2 clinical trial.

Q32 has completed a robust preclinical and translational package and dosing of healthy volunteers in a Phase 1 clinical trial. Q32 plans to initiate Q32’s clinical program in patients with ADX-097 in the first half of 2024 subject to regulatory feedback.

Q32 intends to further evaluate ADX-097’s efficacy and safety profile using biomarkers and functional endpoints in Q32’s planned clinical studies. AAV and other renal diseases have established biomarkers and defined clinical trial endpoints. Current standard of care allows for the possibility of attaining biopsies and, therefore, detailed examination of ADX-097 binding to its target and impact on the relevant complement fragments. Together with urinary markers of complement activation, this data set is expected to provide supportive proof of mechanism and demonstration of target engagement in the diseased tissue.

 

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ADX-097 Preclinical and Clinical Data

Preclinical pharmacology, PD, PK, and toxicology of ADX-097 were assessed in a wide range of in vitro experiments and in vivo nonclinical studies in mice, rats and NHPs. Three non-GLP and two GLP PK, PD and toxicology studies were completed to support clinical development of ADX-097.

These studies have provided compelling evidence for the therapeutic potential of ADX-097. These studies have demonstrated that ADX-097 or a pharmacologically equivalent mouse homolog, ADX-118, which contains the parent mouse anti-C3d antibody used in ADX-097 recombinantly linked to mouse fH1-5, were able to:

 

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Bind C3d and inhibit complement in in vitro assays

 

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Distribute and bind C3d present in rodent kidney, liver, and skin and to NHP skin.

 

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Provide durable anti-complement activity in rodent and NHP tissue, with limited and transient systemic inhibition: durable (>7 days) tissue PD after 1-3 mg/kg SC dosing.

 

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Reduce glomerular C3 fragment deposition, proteinuria/albuminuria, and additional biomarkers of renal injury in rodent models of kidney disease.

 

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Demonstrate increased functional potency compared to similar non-targeted fH1-5 in a passive Heymann nephritis, or PHN, model of kidney disease.

The ADX-097 preclinical toxicology studies were conducted in pharmacologically relevant species, mice and cynomolgus monkeys. It included a cross-reactivity study using human tissues to identify any potential off-target tissue binding, repeat-dose non-GLP studies of 28-day duration in mice and cynomolgus monkeys by SC or intravenous, or IV, administration, and a 29-day GLP repeat-dose toxicology study in cynomolgus monkeys by SC or IV administration. It also included a non-GLP 28-day study and a GLP 3-month study with ADX-118, a mouse homolog protein of ADX-097 with equivalent pharmacological activity, to minimize immunogenicity with long-term dosing. No ADX-097-mediated pharmacological adverse effects were observed in up to 29-day repeat-dose studies in either mice or monkeys. All adverse effects were attributable to an immune-mediated response to a humanized/human fusion protein in NHPs and mice. Consistent with all ADX-097 adverse events being mediated by an immune response to the humanize/human protein, no ADX-118-mediated adverse effects were observed in the 3-month repeat dose studies in mice. The NOAEL was determined at 250 mg/kg by IV weekly dosing (QW), the highest dose tested in the 3-month mouse study, providing support for chronic administration of ADX-097. Overall, the ADX-097 preclinical toxicology analysis provided a > 40x safety margin that Q32 believes supports Q32’s planned dosing for Q32’s Phase 2 renal basket program and AAV clinical trial.

Preliminary Phase 1 Clinical Trial Data

ADX-097 has been evaluated in a completed Phase 1 study conducted in healthy volunteers, study ADX-097-101.

This was a randomized, double-blind, placebo-controlled, single ascending dose, or SAD, and multiple dose study to assess the safety, tolerability, PK, and PD of ADX-097. Data from this study provided initial characterization of the safety, PK, PD, and immunogenicity profile of ADX-097 across a wide range of dose levels, using both IV and SC routes of administration.

In total, 56 healthy volunteers were dosed (randomized 2:1; n=4 ADX-097 and n=2 placebo per cohort): 49 volunteers in the SAD portion of the study and 7 participants in the multiple dose portion. The SAD portion of the study included Cohort 1 (0.1 mg/kg IV), Cohort 2 (0.3 mg/kg IV), Cohort 3 (1 mg/kg IV), Cohort 4a (3 mg/kg IV), Cohort 4b (3 m/kg [actual: 3.75 mg/kg] SC), Cohort 6a (10 mg/kg IV), Cohort 6b (10 mg/kg SC), and Cohort 8 (30 mg/kg IV). The multiple dose portion of the study included multiple ascending dose, or MAD, Cohort 1 (450 mg SC fixed weekly dose).

 

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Blinded safety data indicated that ADX-097 was generally well tolerated across all dose levels with single or repeat dosing with no observed clinically significant drug-related safety findings or trends. All observed treatment-emergent adverse events, or TEAEs, were mild or moderate in severity. There were no observed serious adverse events, no severe TEAEs, no discontinuations due to study drug, and no dose-related trends in TEAEs. Except for one observed TEAE of blood creatine phosphokinase increase in SAD Cohort 1 that was deemed mild by the investigator, there were no observed clinically significant drug-related laboratory findings or trends. In addition, there were no observed clinically significant findings related to vital signs or electrocardiograms, no TEAEs related to immunogenicity, and SC administration was generally well tolerated with only mild injection site reactions observed.

In the PK analysis, ADX-097 demonstrated dose-dependent PK and the minimum drug concentration at a dose of 450 mg SC weekly dosing is estimated to achieve a target threshold associated with tissue pharmacological activity in over 90% of patients. The PD analysis demonstrated increasing inhibition of circulating AP activity and more sustained inhibition with increasing doses. No apparent change in circulating AP activity was observed following 450mg SC weekly dosing. No clinically significant ADA was identified in the ADX-097-101 study, consistent with low immunogenicity potential of ADX-097 in humans. See Figure 23 and Figure 24 for a summary of ADX-0972-101 PK and PD data.

Figure 23: ADX-097-101: Plasma ADX-097 Concentrations and % of Baseline Wieslab AP Activity After Single Dose IV of ADX-097

 

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Figure 24: ADX-097-101: Plasma ADX-097 Concentrations and % of Baseline Wieslab AP Activity After Single/Multiple Dose SC of ADX-097

 

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The Role of Complement in LN, IgAN and C3G

LN is an autoimmune disease that occurs in approximately 50% of patients with systemic lupus erythematosus. It is associated with glomerular immune complex, or IC, deposition, derived either from the circulation or formed in situ from autoantibodies directed against nuclear and cellular antigens, that activates complement resulting in intrarenal inflammation. AP activation has been shown to contribute to complement-mediated tissue injury in LN. LN is divided into 6 histopathological classes according to the International Society of Nephrology/Renal Pathology Society system, based on glomerular IC deposit location, the extent of glomerular involvement, and whether the injury pattern reflects active or chronic disease. The use of immunosuppressive medications is common in the treatment of lupus nephritis. While these drugs can help control the autoimmune response that leads to kidney inflammation, they also increase the risk of infectious complications. Treating physicians are seeking to reduce immunosuppressive medications and enhance safety.

IgAN is an IC-mediated glomerulonephritis characterized by mesangial IgA deposition, activation of complement and glomerular inflammation. The role of complement in mediating local tissue injury in IgAN is widely recognized. Kidney biopsies reveal deposition of complement proteins such as fH, properdin, C4d, mannose-binding lectin, active C3 fragments, and C5b-9, supporting involvement of both the AP and LP. Immune complexes formed from immunoglobulin G, or IgG, autoantibodies and the altered galactose-deficient IgA1 molecules to which they are directed, together with C3 products, contribute to mesangial proliferation and glomerular inflammation. C3 fragments are found in the same distribution as IgA in up to 90% of cases, with increasing mesangial C3 fragment deposition adversely affecting kidney survival. In contrast, individuals with the protective complement fH related protein 3, or CFHR3-1, deletion have reduced glomerular C3 fragment deposition, believed to result from the more effective AP regulation.

C3G is a rare kidney disease caused by dysregulation of the complement AP. Comprising 2 major subgroups, dense deposit disease, or DDD, and C3 glomerulonephritis, or C3GN, it is characterized by C3-dominant glomerular staining by immunofluorescence, of at least 2 orders of intensity greater (on a 0 – 3+ scale) than any other immune reactant (e.g., immunoglobulins). Complement dysregulation can result from genetic mutations in both fluid-phase and surface-bound negative regulator protein fH, or activating proteins, and may also be acquired in the setting of autoantibodies (e.g., directed against fH or which stabilize the C3 convertases (C3 nephritic factors)). Such autoantibodies are more commonly reported in DDD than C3GN. The uncontrolled AP activation common to all results in glomerular C3 fragment deposition and MAC formation.

Current Treatment Landscape and Unmet Need in LN, IgAN and C3G

LN affects 10-250 individuals per million and predominantly women of reproductive age. With heterogeneous pathophysiology, to which genetic and environmental factors likely contribute, the incidence of LN in the U.S. is higher in black (34%-51%), Hispanic (31%-43%), and Asian (33%-55%) patients, compared with white (14%-23%) patients.

The presence of LN increases mortality, with death attributable to renal involvement occurring in 5-25% of patients with proliferative disease (class III, IV, or III/IV + V) within 5 years of onset. Progression to end-stage kidney disease, or ESKD, occurs in 10-30% of those affected by LN, in whom those with proliferative disease are most at risk. Patients with persistently low isolated C3 hypocomplementemia also have an increased risk of ESKD and death. Critical to renal survival is the attainment of a complete clinical response, associated with 92% kidney survival at 10 years, compared to only 43% in partial responders and 13% in non-responders. Despite the continuing development of immunomodulatory agents and supportive care, the prognosis associated with LN has not improved substantially in the past decade, with ESKD still developing in 5-30% of patients within 10 years of LN diagnosis. In prior studies, repeat biopsies after approximately 6 months of treatment in patients with a complete clinical response showed significant persistent histologic activity in a number of cases.

Patient management is determined by disease severity, with non-proliferative forms of LN (with sub–nephrotic range proteinuria and normal glomerular filtration rate, or GFR) typically treated conservatively with renin angiotensin aldosterone system, or RAAS, blockade and immunomodulation with antimalarials (e.g.,

 

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hydroxychloroquine). Immunosuppression is reserved in these classes for extrarenal manifestations only, while proliferative forms of LN (class III, IV, or III/IV+V) and class V LN with nephrotic syndrome are treated with systemic immunosuppression, combined with high-dose corticosteroids, in an induction phase typically lasting 3 to 6 months. Immunosuppression is continued and gradually reduced in an extended maintenance phase (to reduce the risk of flare), potentially lasting several years. While there have been recent approvals for the treatment of LN (with belimumab and voclosporin), unmet therapeutic need remains due to the limited number of treatment options.

IgAN is the most common primary glomerular disease worldwide, with an estimated incidence of 2-28 individuals per million population per year, dependent on geography. Typically occurring in patients aged between 20 and 30 years, up to 50% of patients progress to ESKD within 20 years of clinical presentation. Patients who undergo transplantation are also at risk of disease recurrence, which occurs in approximately 30% of transplant recipients.

Proteinuria is a recognized risk factor for the progression of IgAN, with time-average proteinuria shown to be the most important predictor of rate of kidney function decline. A quantitative estimate determined that each incremental gram of proteinuria above 1g per day was associated with a 10- to 25-fold more rapid rate of kidney function decline. Reducing proteinuria to below 1g/d is therefore regarded as a treatment target in IgAN, with patients achieving this target observed to have a similar rate of disease progression and kidney survival, irrespective of their initial proteinuria and comparable to those whose proteinuria never exceeded 1g/d.

Current SOC for IgAN as described in the Kidney Disease Improving Global Outcomes 2021 guidelines, consists of RAAS inhibition as first line therapy. However, RAAS inhibition does not affect the underlying disease pathology, with less than half of patients achieving sustained proteinuria levels of < 1g/d (partial remission). The long-term clinical benefit of glucocorticoids, or GCs, has not been established and a 6-month course is only suggested with extreme caution in those at high risk of progressive chronic kidney disease. Antibody depleting strategies, such as rituximab, are not recommended due to the paucity of evidence for their efficacy and both treatment approaches carry safety concerns, which are reflected in current treatment guidelines (e.g., KDIGO).

C3G is a rare kidney disease caused by dysregulation of the complement AP. Comprising 2 major subgroups, DDD and C3GN, it is characterized by C3-dominant glomerular staining by immunofluorescence, of at least 2 orders of intensity greater (on a 0–3+ scale) than any other immune reactant (e.g., immunoglobulins).

With an estimated incidence of 1-3 patients per million, C3GN is reportedly more common than DDD in patients with familial C3G. DDD tends to be diagnosed at a younger age, predominantly in children and young adults, but has been reported in older adults. Presentation varies from nephritic syndrome, asymptomatic and low-grade proteinuria to nephrotic syndrome, or rapidly progressive glomerulonephritis, with 50% progressing to ESKD within 10 years. Isolated C3 hypocomplementemia is seen in most patients.

The treatment paradigm for C3G has not been well established. In addition to the standard conservative measures, such as RAAS inhibition and blood pressure control, other tested approaches have included immunosuppression, plasma exchange and complement inhibition with varying degrees of success, and significant therapeutic need remains.

The Role of Complement in AAV

The ANCA-associated vasculitides are a group of autoimmune disorders characterized by severe inflammation of small blood vessels induced by infiltration of neutrophils into vessel walls. Autoimmunity is characterized by the development of autoantibodies to the neutrophil proteins leukocyte proteinase 3 or myeloperoxidase. Patients with AAV typically present with severe organ-threatening or life-threatening disease, although less severe presentations can also occur.

AP complement activation is detected in AAV tissue lesions and is thought to be a major driver of disease pathogenesis. Complement factor B-or C5-deficient mice do not develop glomerulonephritis in an anti-MPO

 

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induced model of AAV. Biomarkers of AP activation, including deposits of C3d, Bb fragment of factor B, or Bb, and C5b-9 are detected in glomeruli and extraglomerular small vessels of AAV kidneys, and Bb, C3a, C5a, and C5b-9 are elevated in urine and serum from AAV patients. Furthermore, serum Bb correlates with disease activity and outcome, and serum C3c concentration correlates with severity of AAV lesions in the kidney. In AAV, hypocomplementemia, as a result of complement overactivation, is reported to be associated with more advanced renal involvement, higher likelihood of treatment resistance, and worse prognosis.

Current Treatment Landscape and Unmet Need in AAV

AAV is a rare disease with a historical estimated global prevalence of 46 to 421 cases per million persons, depending on the population studied and the specific subtype of AAV. The annual incidence of AAV ranges from 10 to 20 cases per million population, with wide variation across geographic regions and substantial variation in the relative incidence of granulomatosis with polyangiitis, or GPA, and microscopic polyangiitis, or MPA, among Europe, the U.S., and Asia.

The presentation and natural history of AAV can be highly variable, and the spectrum of disease may range from relatively mild and localized to the upper respiratory tract, to life-threatening involvement of multiple organ systems. Additionally, disease activity can fluctuate, and relapses may occur. In the current era with SOC, 1-year mortality rates range from approximately 5% to 20% and 5-year mortality can be as high as 50% for the MPA subtype. The highest mortality rates are observed in patients with severe renal involvement, pulmonary hemorrhage, or other life-threatening complications. Severe AAV requires intensive treatment, including high-dose GCs immunosuppressive agents, and sometimes plasma exchange. Despite aggressive therapy, managing severe disease can be challenging, and many patients experience treatment-resistant disease or suffer from irreversible organ damage prior to attainment of disease remission. Furthermore, infections are a leading cause of adverse outcomes, including death, in patients with AAV, a risk generally ascribed to immune-suppressive effects of the treatment regimens used to achieve disease remission. In recent years, intense focus has been on the likely role of GCs in conferring this risk, and there is general acceptance that the reduction and/or elimination of GC in the treatment of AAV is a desirable goal. Avacopan, a recently approved complement C5a receptor inhibitor for AAV, supports complement involvement in the disease but labelling language states that it “does not eliminate glucocorticoid use” and includes warning and precaution language guiding around its use “in patients with underlying conditions that may predispose them to infection.”

Further Clinical Development of ADX-097: Clinical Trial Plan

Based on the preliminary data from Q32’s Phase 1 clinical trial, Q32 plans to initiate a program in human complement-mediated kidney diseases in 2024 and a Phase 2 clinical trial in AAV in the first half of 2025.

The Renal Basket Program

The planned ADX-097-201 study is designed as a basket program to evaluate the safety, PK, PD, and clinical activity of ADX-097 in patients with LN, IgAN or C3G. The primary objective of the study is to evaluate the safety and tolerability of ADX-097 when administered weekly to patients. Key secondary efficacy and exploratory objectives include clinical markers of disease activity, biomarkers of complement activation and organ injury, and pharmacology.

All disease groups will be open label, with a total of up to 30 participants planned for enrollment. Patients will be dosed with a single SC dose weekly for up to 26 weeks. Participants in each disease group will be open to enroll into the study.

AAV

The planned ADX-097-202 study is a Phase 2 study in adults with AAV, specifically GPA and MPA. The study is composed of 2 parts: an open-label Part A, and a randomized, blinded Part B. Part A of the study will

 

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assess the treatment effect of ADX-097 when given as an adjunct to SOC therapy, with the goal of demonstrating initial proof of clinical efficacy. The intent of Part B of the study is to assess the ability of ADX-097 to reduce or eliminate the use of oral glucocorticoids to support induction of remission.

Expanding Q32’s Pipeline of Complement Therapeutics

By leveraging Q32’s extensive experience building fusion biologics and Q32’s deep understanding of the complement system, Q32 aims to create a sustainable pipeline of novel and localized complement inhibitors that are customized for diverse indications. Q32 expects additional preclinical data in 2024 from Q32’s ongoing pipeline efforts in support of advancement of one or more research and development candidates in 2025.

Collaboration and License Agreements

ADX-097—License Agreement – The Regents of the University of Colorado

In August 2017, Q32 entered into an exclusive license agreement, as amended in February 2018, September 2018, and April 2019, or the Colorado License Agreement, with The Regents of the University of Colorado, or Colorado, pursuant to which Q32 obtained worldwide, royalty-bearing, sublicensable licenses under certain patents and know-how owned by Colorado and Medical University of South Carolina, or MUSC, relating to the research, development and commercialization of ADX-097. The licenses granted to Q32 are exclusive with respect to certain patent families and know-how and non-exclusive with certain other patent families and know-how. The licenses granted to Q32 are also subject to certain customary retained rights of Colorado and MUSC and rights of the United States government owing to federal funding giving rise to inventions covered by the licensed patents. Q32 agreed to use commercially reasonable efforts to develop, manufacture and commercialize ADX-097, including by using commercially reasonable efforts to achieve specified development and regulatory milestones by specified dates.

In addition, Q32 agreed to pay Colorado (i) development and sales milestone payments in an aggregate amount of up to $2.2 million per licensed product for the first three products, (ii) tiered royalty rates on cumulative net sales of licensed products in the low single digit percentages, (iii) 15% of sublicense income and (iv) ongoing fees associated with the prosecution, maintenance, or filing of the licensed patents. Q32’s obligation to pay royalties to Colorado commences, on a licensed product-by-licensed product and country-by-country basis, from the first commercial sale of a licensed product in any country and expires on the later of (i) the last to expire valid claim within the licensed patents covering such licensed product in such country, and (ii) 20 years following the effective date of the Colorado License Agreement, or April 2037, or the Royalty Term.

Unless earlier terminated by either party pursuant to its terms, the Colorado License Agreement will expire upon the expiration of the Royalty Term in all countries. Q32 may terminate the Colorado License Agreement for convenience upon providing prior written notice to Colorado. Colorado may terminate the Colorado License Agreement or convert Q32’s exclusive license to a non-exclusive license if Q32 breaches certain obligations under the Colorado License Agreement and fails to cure such breach. The Colorado License Agreement will terminate automatically upon Q32’s dissolution, insolvency, or bankruptcy.

Bempikibart—License Agreement – Bristol-Myers Squibb Company

In September 2019, Q32 entered into a license agreement, as amended in August 2021 and July 2022, or the BMS License Agreement, with Bristol-Myers Squibb Company, or BMS, pursuant to which Q32 obtained sublicensable licenses from BMS to research, develop and commercialize licensed products, including bempikibart, for any and all uses worldwide. The licenses granted to Q32 are exclusive with respect to BMS’s patent rights and know-how relating to certain antibody fragments (including certain fragments of bempikibart) and non-exclusive with respect to BMS’s patent rights and know-how relating to the composition of matter and use of a specific region of bempikibart. BMS retained the right for it and its affiliates to use the exclusively licensed patents and know-how for internal, preclinical research purposes. Under the BMS License Agreement,

 

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Q32 is prohibited from engaging in certain clinical development or commercialization of any antibody other than a licensed compound with the same mechanism of action until the earlier of the expiration of Q32’s obligation to pay BMS royalties or September 2029.

In consideration for the license, Q32 made an upfront payment to BMS of $8 million, issued 6,628,788 Series A preferred shares to BMS and agreed to use commercially reasonable efforts to develop and commercialize at least one licensed product in key geographic markets. In addition, Q32 agreed to pay BMS (i) development and regulatory milestone payments in aggregate amounts ranging from $32 million to $49 million per indication for the first three indications and commercial milestone payments in an aggregate amount of up to $215 million on net sales of licensed products, (ii) tiered royalties ranging from rates in the mid-single digit percentages to up to 10% of net sales, with increasing rates depending on the cumulative net sales, (iii) up to 60% of sublicense income, which percentage decreases based on the development stage of bempikibart at the time of the sublicensing event, and (iv) ongoing fees associated with the prosecution, maintenance, or filing of the licensed patents.

Q32’s obligation to pay BMS royalties under subsection (ii) above commences, on a licensed product-by-licensed product and country-by-country basis, on the first commercial sale of a licensed product in a country and expires on the later of (x) 12 years from the first commercial sale of such Licensed Product in such country, (y) the last to expire licensed patent right covering bempikibart or such licensed product in such country, and (z) the expiration or regulatory or marketing exclusivity for such licensed product in such country, or the Royalty Term. If Q32 undergoes a change of control prior to certain specified phase of development, the development and milestone payments are subject to increase by a low double-digit percentage and the royalty rates are subject to increase by a low sub-single-digit percentage.

Unless terminated earlier by either party pursuant to its terms, the BMS License Agreement will expire on a country-by-country and licensed product-by-licensed product basis upon the expiration of the last to expire Royalty Term with respect to such licensed product in such country. Either party may terminate the BMS License Agreement for the other party’s material breach, subject to a specified notice and cure period. BMS may terminate the BMS License Agreement if Q32 fails to meet its diligence obligations under the BMS License Agreement, for Q32’s insolvency, or if Q32 or its affiliates challenges the validity, scope, enforceability, or patentability of any of the licensed patents. Q32 may terminate the BMS License Agreement for any reason upon prior written notice to BMS, with a longer notice period if a licensed product has received regulatory approval. If the BMS Agreement is terminated for Q32’s material breach, BMS will regain rights to bempikibart and Q32 must grant BMS an exclusive license under Q32’s patent rights covering bempikibart, subject to a low single-digit percentage royalty on net sales of bempikibart payable to Q32 by BMS.

Bempikibart – Collaboration and Option Agreement, Asset Purchase Agreement and Termination Agreement – Horizon Therapeutics Ireland DAC)

From August 2022 until November 2023, Q32 was a party to the Collaboration and Option Agreement, or the Horizon Collaboration Agreement, and the Asset Purchase Agreement, or the Purchase Agreement, and together with the Horizon Collaboration Agreement, the Horizon Agreements each with Horizon Therapeutics Ireland DAC, or Horizon, pursuant to which Q32 received $55.0 million in initial consideration and staged development funding to complete two ongoing Phase 2 trials for bempikibart, and granted Horizon an option to acquire the bempikibart program at a prespecified price, subject to certain adjustments.

In October 2023, Amgen, Inc., or Amgen, completed the acquisition of Horizon Therapeutics public limited company, or Horizon plc. Following its acquisition of Horizon plc, Q32 agreed with Amgen to mutually terminate the Horizon Agreements and in November 2023, Q32 and Horizon entered into a termination agreement, or the Horizon Termination Agreement, pursuant to which Horizon’s option to acquire the bempikibart program was terminated. As a result, Q32 retained all initial consideration and development funding received under the Horizon Collaboration Agreement and regained full development and commercial rights to

 

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bempikibart. In consideration for the Horizon Termination Agreement, Q32 agreed to pay Horizon regulatory and sales milestones payments of up to an aggregate amount of $75.1 million upon the first achievement of certain regulatory and sales milestones with respect to bempikibart.

Competition

Q32 expects to face intense competition from other biopharmaceutical companies that are developing agents for the treatment of autoimmune and inflammatory diseases. Drug development is highly competitive and subject to rapid and significant technological advancements. Q32’s ability to compete will significantly depend upon Q32’s ability to complete necessary clinical trials and regulatory approval processes, and effectively market any drug that Q32 may successfully develop. Q32’s current and potential future competitors include pharmaceutical and biotechnology companies, as well as academic institutions and government agencies. The primary competitive factors that will affect the commercial success of any product candidate for which Q32 may receive marketing approval include efficacy, safety and tolerability profile, dosing convenience, price, coverage, reimbursement and public opinion. Many of Q32’s existing or potential competitors have substantially greater financial, technical and human resources than Q32 does and significantly greater experience in the discovery and development of product candidates, as well as in obtaining regulatory approvals of those product candidates in the U.S. and in foreign countries. Q32’s current and potential future competitors also have significantly more experience commercializing drugs that have been approved for marketing. Mergers and acquisitions in the biopharmaceutical industry could result in even more resources being concentrated among a small number of Q32’s competitors. Accordingly, competitors may be more successful than Q32 in obtaining regulatory approval for therapies and in achieving widespread market acceptance of their drugs. It is also possible that the development of a cure or more effective treatment method for any of Q32’s targeted indications by a competitor could render Q32’s product candidate non-competitive or obsolete, or reduce the demand for Q32’s product candidate before Q32 can recover its development and commercialization expenses.

Manufacturing

Q32 does not currently own or operate facilities for product manufacturing, testing, storage, and distribution. Q32 contracts with third parties for the manufacture and distribution of Q32’s product candidates. Because Q32 relies on contract manufacturers, Q32 employs and contracts with personnel with extensive technical, manufacturing, analytical and quality experience. Q32’s staff has strong knowledge and understanding of the extensive regulations that govern manufacturing, documentation, quality assurance, and quality control of drug supply that are required to support Q32’s regulatory filings.

Intellectual Property

Q32 strives to protect and enhance the proprietary technology, inventions, and improvements that are commercially important to Q32’s business, including by seeking, maintaining, and defending patent rights, whether developed internally or licensed from third parties. Q32 also relies on trade secrets and know-how relating to Q32’s proprietary technology and product candidates, continuing technological innovation, and in-licensing opportunities to develop, strengthen, and maintain Q32’s proprietary position in the field of autoimmune and inflammatory diseases. Q32’s future success depends, in part, on Q32’s ability to obtain and maintain patent and other proprietary protection for Q32’s commercially important technology, inventions, and know-how, defend and enforce Q32’s intellectual property rights (in particular Q32’s patent rights), preserve the confidentiality of Q32’s trade secrets, and operate without infringing, misappropriating, or violating the valid and enforceable patents and proprietary rights of third parties. Q32’s ability to stop third parties from making, using, selling, offering to sell, or importing products identical or similar to Q32’s may depend on the extent to which Q32 has rights under valid and enforceable patents that cover these activities.

The patent position of biotechnology and pharmaceutical companies are generally uncertain and can involve complex legal, scientific, and factual issues. Q32 cannot predict whether the patent applications Q32 is currently

 

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pursuing will issue as patents in any particular jurisdiction or whether the claims of any issued patents will provide sufficient proprietary protection from competitors. Q32 also cannot ensure that patents will issue with respect to any patent applications that Q32 or Q32’s licensors may file in the future, nor can Q32 ensure that any of Q32’s owned or licensed patents or future patents will be commercially useful in protecting Q32’s product candidates and methods of manufacturing. In addition, the coverage claimed in a patent application may be significantly reduced before a patent is issued, and its scope can be reinterpreted and even challenged after issuance. As a result, Q32 cannot guarantee that any of Q32’s products will be protected or remain protectable by valid and enforceable patents. Moreover, any of Q32’s patents may be challenged, circumvented, or invalidated by third parties.

Prosecution is a lengthy process, during which the scope of the claims initially submitted for examination by the U.S. Patent and Trademark Office, or USPTO, may be significantly narrowed before issuance, if issued at all. Q32 expects this may be the case with respect to some of Q32’s pending patent applications referred to below.

With respect to Q32’s ADX-097 program, as of October 1, 2023, Q32 owns one patent family relating to ADX-097, other fusion constructs of anti-C3d antibodies and different complement modulators. This family includes two issued U.S. patents, one allowed U.S. patent application, and 24 pending applications in Australia, Canada, China, Europe, Hong Kong, India, Indonesia, Israel, Japan, South Korea, Malaysia, Mexico, New Zealand, Philippines, Russia, Saudi Arabia, Singapore, South Africa, United Arab Emirates, Qatar, Bahrain, Kuwait, and Oman. The issued patent that covers ADX-097, and any patents that issue from these pending patent applications are expected to expire in December 2039, without accounting for potentially available patent term adjustments or extensions in the U.S. or abroad.

With respect to bempikibart, as of October 1, 2023, Q32 exclusively licensed from Bristol Myers Squibb, or BMS, one patent family relating to antibodies against the IL-7R alpha subunit and uses thereof comprising one issued U.S. patent, one issued patent in each of Japan, South Korea, and Singapore, one pending U.S. patent application, and 32 pending patent applications in Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Europe, Hong Kong, India, Indonesia, Israel, Japan, South Korea, Malaysia, Mexico, New Zealand, Peru, Philippines, Russia, Saudi Arabia, South Africa, Taiwan, Thailand, United Arab Emirates Qatar, Bahrain, Egypt, Kuwait, and Oman. The issued patent is expected to expire in January 2040 and any patents that issue from these pending patent applications are expected to expire in 2040, without accounting for potentially available patent term adjustments or extensions in the U.S. or abroad. Q32 also owns two pending U.S. provisional patent applications related to the use of bempikibart for the treatment of atopic dermatitis and hair loss disorders. Any patents that issue from patent applications that claim priority to this U.S. provisional application are expected to expire in 2044, without accounting for potentially available patent term adjustments or extensions.

Q32 also owns one pending U.S. provisional patent application relating to targeted treatment of complement-media disease through local complement inhibition based on detection of a urinary biomarker. Any patents that issue from patent applications that claim priority to this U.S. provisional application are expected to expire in 2044, without accounting for potentially available patent term adjustments or extensions in the U.S. or abroad.

Q32 has licensed from various institutions additional patent families that are generally related to C3d targeted complement inhibitors, but that do not specifically cover ADX-097:

 

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One patent family from the Regents of the University of Colorado, or CU, the MUSC Foundation For Research Development, or MUSC, and the U.S. Department of Veterans Affairs, or USDVA, relating to targeted complement inhibitor constructs based on natural antibodies and uses thereof includes two granted Australian patents and one granted patent in each of Israel and Japan. These patents are expected to expire in 2034, without accounting for potentially available patent term adjustments or extensions in the U.S. or abroad.

 

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Two patent families from CU, the first relating to MAP44 polypeptides and tissue-targeted fusion constructs and uses thereof, and the second relating to modulating the alternative complement pathway.

 

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The first patent family includes one granted patent in each of Australia and Israel and pending patent applications in the U.S., Canada and Australia. The issued patents and any patents that issue from the pending patent applications are expected to expire in 2035, without accounting for potentially available patent term adjustments or extensions in the U.S. or abroad. The second patent family includes three issued U.S. patents, which are expected to expire in 2029, without accounting for potentially available patent term adjustments or extensions in the U.S. or abroad.

 

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Two patent families from MUSC and USDVA, the first relating to compositions and methods for treating central nervous system injury using a targeted complement inhibitor and another agent or therapy and the second relating to compositions and methods for treating and preventing transplant-associated injury. The first patent family includes one issued U.S. patent, one pending U.S. patent application, and one pending patent application in Europe. The issued patent and any patents that issue from the pending patent applications are expected to expire in 2037, without accounting for potentially available patent term adjustments or extensions in the U.S. or abroad. The second patent family includes one pending U.S. patent application and one pending patent application in Europe. Any patents that issue from these pending patent applications are expected to expire in 2037, without accounting for potentially available patent term adjustments or extensions in the U.S. or abroad.

 

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One patent family from CU and MUSC relating to antibodies against the C3d fragment of complement component 3 includes one reissue patent in the U.S. This patent is expected to expire in 2037, without accounting for potentially available patent term adjustments or extensions in the U.S. or abroad.

While Q32 believes that the specific and generic claims contained in Q32’s patents provide protection for the claimed compounds, pharmaceutical compositions and methods of use, third parties may nevertheless challenge such claims. If any such claims are invalidated or rendered unenforceable for any reason, Q32 could lose valuable intellectual property rights and Q32’s ability to prevent others from competing with Q32’s products and technology would be impaired.

The term of individual patents depends upon the legal term of the patents in the countries in which they are obtained. In most countries in which Q32 pursues patent protection, the patent term is 20 years from the earliest date of filing a non-provisional patent application. In the United States, the term of a patent covering an FDA-approved drug may, in certain cases, be eligible for a patent term extension under the Hatch-Waxman Act as compensation for the loss of patent term during the FDA regulatory review process. The period of extension may be up to five years, but the remaining term of a patent cannot be extended beyond a total of 14 years from the date of product approval. Only one patent among those eligible for an extension and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended. Similar provisions are available in Europe and in certain other jurisdictions to extend the term of a patent that covers an approved drug. Q32 intends to seek patent term extension for patents covering Q32’s products if available.

In addition to patent protection, Q32 may also rely, in some circumstances, on trade secrets to protect Q32’s technology. To that end, Q32 also enters into confidentiality agreements with those who have access to Q32’s confidential information, including Q32’s employees, contractors, consultants, collaborators and advisors. Q32 also enters into agreements requiring assignment of inventions with selected consultants, scientific advisors, and collaborators. However, trade secrets are difficult to protect. These agreements may not provide meaningful protection and may be breached without an adequate remedy for any such breach. In addition, Q32’s trade secrets and/or confidential information and know-how may become known or be independently developed by a third party, or misused by any collaborator to whom Q32 discloses such information. Despite any measures taken to protect Q32’s intellectual property, unauthorized parties may attempt to copy aspects of Q32’s products or obtain or use information that Q32 regards as proprietary. Although Q32 takes steps to protect Q32’s proprietary information, third parties may independently develop the same or similar proprietary information or may otherwise gain access to Q32’s proprietary information. As a result, Q32 may be unable to meaningfully protect Q32’s trade secrets and proprietary information.

 

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Q32’s success will also depend in part on not infringing upon the proprietary rights of third parties. It is uncertain whether the issuance of any third-party patent would require Q32 to alter Q32’s strategies, obtain licenses, or cease certain activities. Q32’s breach of any license agreements or failure to obtain a license to proprietary rights that Q32 needs may have an adverse impact on Q32’s business.

For more information and comprehensive risks related to Q32’s proprietary technology, inventions, improvements and product candidates, see the section titled “Risk Factors—Risks Relating to Q32’s Intellectual Property.”

Government Regulation

The U.S. Food and Drug Administration, or the FDA, and other regulatory authorities at federal, state and local levels, as well as in foreign countries, extensively regulate, among other things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, record keeping, approval, advertising, promotion, marketing, post-approval monitoring and post-approval reporting of biologics such as those we are developing. We, along with third-party contractors, will be required to navigate the various preclinical, clinical and commercial approval requirements of the governing regulatory agencies of the countries in which we are currently conducting and in the future may conduct studies or seek approval or licensure of our product candidates. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or post-market may subject an applicant to administrative or judicial sanctions. These sanctions could include, among other actions, the FDA’s refusal to approve pending applications, withdrawal of an approval, a clinical hold, untitled or warning letters, product recalls or market withdrawals, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement and civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on our business.

U.S. Biologics Regulation

In the United States, biological products are subject to regulation under the Federal Food, Drug, and Cosmetic Act, or the FDCA, and the Public Health Service Act, or the PHSA, and their implementing regulations, as well as other federal, state, local, and foreign statutes and regulations. The process required by the FDA before biologic product candidates may be marketed in the United States generally involves the following:

 

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completion of preclinical laboratory tests and animal studies performed in accordance with applicable regulations, including the FDA’s Good Laboratory Practices, or GLP;

 

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submission to the FDA of an investigational new drug application, or IND, which must become effective before clinical trials may begin and must be updated annually or when significant changes are made;

 

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approval by an independent institutional review board, or IRB, or independent ethics committee at each clinical site before the trial may be commenced;

 

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manufacture of the proposed biologic candidate in accordance with current Good Manufacturing Practices, or cGMPs;

 

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performance of adequate and well-controlled human clinical trials in accordance with applicable IND regulations, Good Clinical Practice, or GCP, requirements and other clinical-trial related regulations to establish the safety, purity and potency of the proposed biologic product candidate for its intended purpose;

 

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preparation of and submission to the FDA of a biologics license application, or BLA, after completion of all pivotal clinical trials;

 

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satisfactory completion of an FDA Advisory Committee review, if applicable;

 

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a determination by the FDA within 60 days of its receipt of a BLA to file the application for review;

 

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satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced to assess compliance with cGMPs, and to assure that the facilities, methods and controls are adequate to preserve the biological product’s continued safety, purity and potency, and potential audit of selected clinical investigation sites to assess compliance with GCPs;

 

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payment of user fees for FDA review of the BLA, unless a waiver is applicable; and

 

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FDA review and approval of a BLA to permit commercial marketing of the product for a particular indication(s) for use in the United States.

Preclinical and Clinical Development

Prior to beginning the first clinical trial with a product candidate, a sponsor must submit an IND to the FDA. An IND is a request for authorization from the FDA to administer an investigational new drug product to humans. The central focus of an IND submission is on the general investigational plan and the protocol or protocols for preclinical studies and clinical trials. The IND also includes results of animal and in vitro studies assessing the toxicology, pharmacokinetics, pharmacology and pharmacodynamic characteristics of the product, chemistry, manufacturing and controls information, and any available human data or literature to support the use of the investigational product. An IND must become effective before clinical trials may begin. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day period, raises safety concerns or questions about the proposed clinical trial. In such a case, the IND may be placed on clinical hold and the IND sponsor and the FDA must resolve any outstanding concerns or questions before the clinical trial can begin. Submission of an IND therefore may or may not result in FDA authorization to begin a clinical trial.

Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in accordance with GCPs, which include the requirement that all research participants provide their informed consent for their participation in any clinical study. Clinical trials are conducted under protocols detailing, among other things, the objectives of the study, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A separate submission to the existing IND must be made for each successive clinical trial conducted during product development and for any subsequent protocol amendments. Furthermore, an independent IRB for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent form before the clinical trial begins at that site, and must monitor the study until completed.

Regulatory authorities, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives. Some studies also include oversight by an independent group of qualified experts organized by the clinical study sponsor, known as a data safety monitoring board, which provides authorization for whether or not a study may move forward at designated check points based on access to certain data from the study and may recommend halting the clinical trial if it determines that there is an unacceptable safety risk for subjects or other grounds, such as no demonstration of efficacy. There are also requirements governing the reporting of ongoing preclinical studies and clinical trials and clinical study results to public registries. Sponsors of clinical trials of FDA-regulated products, including biological products, are required to register and disclose certain clinical trial information, which is publicly available at www.clinicaltrials.gov.

A sponsor who wishes to conduct a clinical trial outside of the United States may, but need not, obtain FDA authorization to conduct the clinical trial under an IND. If a foreign clinical trial is not conducted under an IND, the sponsor may submit data from the clinical trial to the FDA in support of a BLA. The FDA will accept a well-designed and well-conducted foreign clinical trial not conducted under an IND if the trial was conducted in accordance with GCP requirements and the FDA is able to validate the data through an onsite inspection if deemed necessary.

 

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For purposes of BLA approval, human clinical trials are typically conducted in three sequential phases that may overlap.

 

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Phase 1. The investigational product is initially introduced into healthy human subjects or patients with the target disease or condition. These studies are designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.

 

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Phase 2. The investigational product is administered to a limited patient population with a specified disease or condition to evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks. Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials.

 

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Phase 3. The investigational product is administered to an expanded patient population to further evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval.

In some cases, the FDA may require, or companies may voluntarily pursue, additional clinical trials after a product is approved to gain more information about the product. These so-called Phase 4 studies may be made a condition to approval of the BLA. Concurrent with clinical trials, companies may complete additional animal studies and develop additional information about the biological characteristics of the product candidate, and must finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, must develop methods for testing the safety, purity and potency of the final product. Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.

During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data and clinical study investigators. Written IND safety reports must be promptly submitted to the FDA and the investigators for serious and unexpected suspected adverse events, any findings from other studies, tests in laboratory animals or in vitro testing that suggest a significant risk for human subjects, or any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure. The sponsor must submit an IND safety report within 15 calendar days after the sponsor determines that the information qualifies for reporting. The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction within seven calendar days after the sponsor’s initial receipt of the information.

BLA Submission and Review

Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development, preclinical studies and clinical trials are submitted to the FDA as part of a BLA requesting approval to market the product for one or more indications. FDA approval of a BLA must be obtained before a biologic may be marketed in the United States. The BLA must include all relevant data available from pertinent preclinical studies and clinical trials, including negative or ambiguous results as well as positive findings, together with detailed information relating to the product’s chemistry, manufacturing, controls, and proposed labeling, among other things. Data can come from company-sponsored clinical studies intended to test the safety and effectiveness of the product, or from a number of alternative sources, including studies initiated and sponsored by investigators. The submission of a BLA requires payment of a substantial application user fee to the FDA, unless a waiver or exemption applies.

In addition, under the Pediatric Research Equity Act, or PREA, a BLA or supplement to a BLA must contain data to assess the safety and effectiveness of the biological product candidate for the claimed indications

 

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in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The Food and Drug Administration Safety and Innovation Act requires that a sponsor who is planning to submit a marketing application for a biological product that includes a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration submit an initial pediatric study plan, or PSP, within sixty days after an end-of-Phase 2 meeting or, if there is no such meeting, as early as practicable before the initiation of the Phase 3 or Phase 2/3 study as may be agreed between the sponsor and FDA. The initial PSP must include an outline of the pediatric study or studies that the

sponsor plans to conduct, including study objectives and design, age groups, relevant endpoints and statistical approach, or a justification for not including such detailed information, and any request for a deferral of pediatric assessments or a full or partial waiver of the requirement to provide data from pediatric studies along with supporting information. The FDA and the sponsor must reach an agreement on the PSP. A sponsor can submit amendments to an agreed-upon initial PSP at any time if changes to the pediatric plan need to be considered based on data collected from preclinical studies, early phase clinical trials and/or other clinical development programs. Unless otherwise required by regulation, PREA does not apply to any biological product for an indication for which orphan designation has been granted.

Within 60 days following submission of the application, the FDA reviews the BLA to determine if it is substantially complete before the agency accepts it for filing. The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at the time of submission and may request additional information. In this event, the BLA must be resubmitted with the additional information. Once a BLA has been accepted for filing, the FDA’s goal is to review standard applications within ten months after the filing date, or, if the application qualifies for priority review, six months after the FDA accepts the application for filing. In both standard and priority reviews, the review process may also be extended by FDA requests for additional information or clarification. The FDA reviews a BLA to determine, among other things, whether a product is safe, pure and potent and the facility in which it is manufactured, processed, packed or held meets standards designed to assure the product’s continued safety, purity and potency. The FDA may convene an advisory committee to provide clinical insight on application review questions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.

Before approving a BLA, the FDA will typically inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving a BLA, the FDA will typically inspect one or more clinical sites to assure compliance with GCPs. If the FDA determines that the application, manufacturing process or manufacturing facilities are not acceptable, it typically will outline the deficiencies in the submission and often will request additional testing or information. Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.

After the FDA evaluates a BLA and conducts inspections of manufacturing facilities where the investigational product and/or its drug substance will be produced, the FDA may issue an approval letter or a Complete Response Letter. An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications. A Complete Response Letter will describe all of the deficiencies that the FDA has identified in the BLA, except that where the FDA determines that the data supporting the application are inadequate to support approval, the FDA may issue the Complete Response Letter without first conducting required inspections, testing submitted product lots and/or reviewing proposed labeling. In issuing the Complete Response Letter, the FDA may recommend actions that the applicant might take to place the BLA in condition for approval, including requests for additional information or clarification. If a Complete Response Letter is issued, the applicant may either resubmit the BLA, addressing all of the deficiencies identified in the letter, or withdraw the application or request an opportunity for a hearing. The FDA may delay or refuse approval of a BLA if applicable regulatory criteria are not satisfied, require additional testing or information and/or require post-marketing testing and surveillance to monitor safety or efficacy of a product.

 

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If regulatory approval of a product is granted, such approval will be granted for particular indications and may entail limitations on the indicated uses for which such product may be marketed. For example, the FDA may approve the BLA with a Risk Evaluation and Mitigation Strategy, or REMS, to ensure the benefits of the product outweigh its risks. A REMS is a safety strategy to manage a known or potential serious risk associated with a product and to enable patients to have continued access to such medicines by managing their safe use, and could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. The FDA also may condition approval on, among other things, changes to proposed labeling or the development of adequate controls and specifications. Once approved, the FDA may withdraw the product approval if compliance with pre-and post-marketing requirements is not maintained or if problems occur after the product reaches the marketplace. The FDA may require one or more Phase 4 post-market studies and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization, and may limit further marketing of the product based on the results of these post-marketing studies.

Expedited Development and Review Programs

The FDA offers a number of expedited development and review programs for qualifying product candidates. The fast track program is intended to expedite or facilitate the process for reviewing new products that meet certain criteria. Specifically, new product candidates are eligible for fast track designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition. Fast track designation applies to the combination of the product candidate and the specific indication for which it is being studied. The sponsor of a fast track product candidate has opportunities for more frequent interactions with the review team during product development and, once a BLA is submitted, the product candidate may be eligible for priority review. A fast track product candidate may also be eligible for rolling review, where the FDA may consider for review sections of the BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the BLA, the FDA agrees to accept sections of the BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the BLA.

A product candidate intended to treat a serious or life-threatening disease or condition may also be eligible for breakthrough therapy designation to expedite its development and review. A product candidate can receive breakthrough therapy designation if preliminary clinical evidence indicates that the product candidate, alone or in combination with one or more other drugs or biologics, may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. The designation includes all of the fast track program features, as well as more intensive FDA interaction and guidance beginning as early as Phase 1 and an organizational commitment to expedite the development and review of the product, including involvement of senior managers.

Any marketing application for a biologic submitted to the FDA for approval, including a product candidate with a fast track designation and/or breakthrough therapy designation, may be eligible for other types of FDA programs intended to expedite the FDA review and approval process, such as priority review and accelerated approval. A product candidate is eligible for priority review if it has the potential to provide a significant improvement in the treatment, diagnosis or prevention of a serious disease or condition. For original BLAs, priority review designation means the FDA’s goal is to take action on the marketing application within six months of the 60-day filing date (as compared to ten months under standard review).

Additionally, product candidates studied for their safety and effectiveness in treating serious or life-threatening diseases or conditions may receive accelerated approval upon a determination that the product candidate has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. As a condition of accelerated

 

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approval, the FDA will generally require the sponsor to perform adequate and well-controlled post-marketing clinical studies with due diligence to verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit. Under the Food and Drug Omnibus Reform Act of 2022, or FDORA, the FDA may require, as appropriate, that such studies be underway prior to approval or within a specific time period after the date of approval for a product granted accelerated approval. Under FDORA, the FDA has increased authority for expedited procedures to withdraw approval of a product or indication approved under accelerated approval if the sponsor fails to conduct the required post-marketing studies or if such studies fail to verify the predicted clinical benefit. In addition, the FDA currently requires as a condition for accelerated approval pre-approval of promotional materials, which could adversely impact the timing of the commercial launch of the product.

Fast track designation, breakthrough therapy designation and priority review do not change the standards for approval but may expedite the development or approval process. Even if a product candidate qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.

Orphan Drug Designation and Exclusivity

Under the Orphan Drug Act of 1983, the FDA may grant orphan drug designation to a product candidate intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or 200,000 or more individuals in the United States for which there is no reasonable expectation that the cost of developing and making available in the United States a drug or biologic for this type of disease or condition will be recovered from sales in the United States for that product candidate. Orphan drug designation must be requested before submitting a BLA. After the FDA grants orphan drug designation, the identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. The orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review or approval process.

If a product that has orphan drug designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan drug exclusive approval (or exclusivity), which means that the FDA may not approve any other applications, including a full BLA, to market the same product for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity by means of greater effectiveness, greater safety or providing a major contribution to patient care or if the holder of the orphan drug exclusivity cannot assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the product was designated. Orphan drug exclusivity does not prevent the FDA from approving a different drug or biologic for the same disease or condition, or the same drug or biologic for a different disease or condition. Among the other benefits of orphan drug designation are tax credits for certain research and a waiver of the BLA application fee.

A designated orphan drug may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which it received orphan drug designation. In addition, exclusive marketing rights in the United States may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition.

Post-Approval Requirements

Any products manufactured or distributed by us pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and distribution, and advertising and promotion of the product. As part of the manufacturing process, the manufacturer is required to perform certain tests on each lot of the product before it is released for distribution. After a BLA is approved for a biological

 

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product, the product also may be subject to official lot release. If the product is subject to official release by the FDA, the manufacturer submits samples of each lot of product to the FDA together with a release protocol showing a summary of the history of manufacture of the lot and the results of all of the manufacturer’s tests performed on the lot. The FDA also may perform certain confirmatory tests on lots of some products before releasing the lots for distribution by the manufacturer. In addition, the FDA conducts laboratory research related to the regulatory standards on the safety, purity, potency and effectiveness of biologics. After approval, most

changes to the approved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval. There also are continuing user fee requirements, under which the FDA assesses an annual program fee for each product identified in an approved BLA. Biologic manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMPs, which impose certain procedural and documentation requirements upon us and our third-party manufacturers. Changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMPs and impose reporting requirements upon us and any third-party manufacturers that we may decide to use. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain compliance with cGMPs and other aspects of regulatory compliance.

The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical studies to assess new safety risks; or imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among other things:

 

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restrictions on the marketing or manufacturing of a product, complete withdrawal of the product from the market or product recalls;

 

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fines, warning letters or holds on post-approval clinical studies;

 

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refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of existing product approvals;

 

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product seizure or detention, or refusal of the FDA to permit the import or export of products;

 

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consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs;

 

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mandated modification of promotional materials and labeling and the issuance of corrective information;

 

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the issuance of safety alerts, Dear Healthcare Provider letters, press releases and other communications containing warnings or other safety information about the product; or

 

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injunctions or the imposition of civil or criminal penalties.

The FDA closely regulates the marketing, labeling, advertising and promotion of biologics. A company can make only those claims relating to safety and efficacy, purity and potency that are approved by the FDA and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. Failure to comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties. Physicians may prescribe legally available products for uses that are not described in the product’s labeling and that differ from those tested by the sponsor and approved by the FDA. Such off-label uses are common across medical specialties. Physicians may believe that such off-label uses are the best treatment for

 

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many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, restrict manufacturer’s communications on the subject of off-label use of their products.

Biosimilars and Reference Product Exclusivity

The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the ACA, includes a subtitle called the Biologics Price Competition and Innovation Act of 2009, or BPCIA, which created an abbreviated approval pathway for biological products that are highly similar, or “biosimilar,” to or interchangeable with an FDA-approved reference biological product. The FDA has issued several guidance documents outlining an approach to review and approval of biosimilars.

Biosimilarity, which requires that there be no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency, is generally shown through analytical studies, animal studies, and a clinical study or studies. Interchangeability requires that a product is biosimilar to the reference product and the product must demonstrate that it can be expected to produce the same clinical results as the reference product in any given patient and, for products that are administered multiple times to an individual, the biologic and the reference biologic may be alternated or switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic. A product shown to be biosimilar or interchangeable with an FDA-approved reference biological product may rely in part on the FDA’s previous determination of safety and effectiveness for the reference product for approval, which can potentially reduce the cost and time required to obtain approval to market the product.

Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that the reference product was first licensed by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from the date on which the reference product was first licensed. During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing that applicant’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of its product. The BPCIA also created certain exclusivity periods for biosimilars approved as interchangeable products. FDA-approved interchangeable biosimilars may be substituted for the reference product without the intervention of the prescribing health care provider, subject to state laws, which differ by state.

A biological product can also obtain pediatric market exclusivity in the United States. Pediatric exclusivity, if granted, adds six months to existing exclusivity periods and patent terms. This six-month exclusivity, which runs from the end of other exclusivity protection or patent term, may be granted based on the voluntary completion of a pediatric study in accordance with an FDA-issued “Written Request” for such a study.

The BPCIA is complex and continues to be interpreted and implemented by the FDA. In July 2018, the FDA announced an action plan to encourage the development and efficient review of biosimilars, including the establishment of a new office within the agency that will focus on therapeutic biologics and biosimilars. On December 20, 2020, Congress amended the PHSA as part of the COVID-19 relief bill to further simplify the biosimilar review process by making it optional to show that conditions of use proposed in labeling have been previously approved for the reference product, which used to be a requirement of the application. In addition, government proposals have sought to reduce the 12-year reference product exclusivity period. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject of recent litigation. As a result, the ultimate impact, implementation, and impact of the BPCIA is subject to significant uncertainty.

As discussed below, the Inflation Reduction Act of 2022, or IRA, is a significant new law that intends to foster generic and biosimilar competition and to lower drug and biologic costs.

 

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Other Healthcare Laws and Compliance Requirements

Pharmaceutical companies are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which they conduct their business. Such laws include, without limitation: the federal Anti-Kickback Statute, or AKS; the federal False Claims Act, or FCA; the Health Insurance Portability and Accountability Act of 1996, or HIPAA, and similar foreign, federal and state fraud, abuse and transparency laws.

The AKS prohibits, among other things, persons and entities from knowingly and willfully soliciting, receiving, offering or paying remuneration, to induce, or in return for, either the referral of an individual, or the purchase, lease, order, arrangement, or recommendation of an item or service for which payment may be made under any federal healthcare program. The term remuneration has been interpreted broadly to include anything of value. The AKS has been interpreted to apply to arrangements between pharmaceutical manufacturers on one hand, and prescribers and purchasers on the other. The government often takes the position that to violate the AKS, only one purpose of the remuneration need be to induce referrals, even if there are other legitimate purposes for the remuneration. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to have committed a violation. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from AKS prosecution, but they are drawn narrowly and practices that involve remuneration, such as consulting agreements, that may be alleged to be intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do not qualify for an exception or safe harbor. Our practices may not in all cases meet all of the criteria for protection under a statutory exception or regulatory safe harbor. Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the AKS. Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of its facts and circumstances. Violations are subject to civil and criminal fines and penalties for each violation, plus up to three times the remuneration involved, imprisonment, and exclusion from government healthcare programs. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act or federal civil monetary penalties.

Civil and criminal false claims laws, including the FCA, and civil monetary penalty laws, which impose criminal and civil penalties and can be enforced through civil whistleblower or qui tam actions, prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment of federal government funds, including in federal healthcare programs, that are false or fraudulent; knowingly making, using or causing to be made or used, a false statement of record material to a false or fraudulent claim or obligation to pay or transmit money or property to the federal government or knowingly concealing or knowingly and improperly avoiding or decreasing an obligation to pay money to the federal government. Pharmaceutical and other healthcare companies have been prosecuted under these laws for engaging in a variety of different types of conduct that “caused” the submission of false claims to federal healthcare programs. Under the AKS, for example, a claim resulting from a violation of the AKS is deemed to be a false or fraudulent claim for purposes of the FCA. Manufacturers can be held liable under the federal False Claims Act even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims. The federal False Claims Act also permits a private individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the federal False Claims Act and to share in any monetary recovery.

HIPAA created additional federal criminal statutes that prohibit, among other things, executing a scheme to defraud any healthcare benefit program, including private third-party payors, and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements or representations relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.

 

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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH and their respective implementing regulations, including the Final Omnibus Rule published in January 2013, which impose requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates, independent contractors or agents of covered entities, that perform services for them that involve the creation, maintenance, receipt, use, or disclosure of, individually identifiable health information relating to the privacy, security and transmission of individually identifiable health information. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions. In addition, there may be additional federal, state and non-U.S. laws which govern the privacy and security of health and other personal information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

The FDCA addresses, among other things, the design, production, labeling, promotion, manufacturing, and testing of drugs, biologics and medical devices, and prohibits such acts as the introduction into interstate commerce of adulterated or misbranded drugs or devices. The PHSA also prohibits the introduction into interstate commerce of unlicensed or mislabeled biological products.

The U.S. federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to annually report to the Centers for Medicaid & Medicare Services, or CMS, information related to payments or other transfers of value made to various healthcare professionals including physicians, certain other licensed health care practitioners, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.

We are also subject to federal price reporting laws and federal consumer protection and unfair competition laws. Federal price reporting laws require manufacturers to calculate and report complex pricing metrics to government programs, where such reported prices may be used in the calculation of reimbursement and/ or discounts on approved products. Federal consumer protection and unfair competition laws broadly regulate marketplace activities and activities that potentially harm consumers.

Further, we are subject to additional similar U.S. state and foreign law equivalents of each of the above federal laws, which, in some cases, differ from each other in significant ways, and may not have the same effect, thus complicating compliance efforts. If our operations are found to be in violation of any of such laws or any other governmental regulations that apply, it may be subject to penalties, including, without limitation, civil, criminal and administrative penalties, damages, fines, exclusion from government-funded healthcare programs, such as Medicare and Medicaid or similar programs in other countries or jurisdictions, integrity oversight and reporting obligations to resolve allegations of non-compliance, disgorgement, individual imprisonment, contractual damages, reputational harm, diminished profits and the curtailment or restructuring of its operations.

Data Privacy and Security

Numerous state, federal and foreign laws govern the collection, dissemination, use, access to, confidentiality and security of personal information, including health-related information. As our operations and business grow, we may become subject to or affected by U.S. federal and state laws and regulations, including the Health Information Portability and Accountability Act of 1996, and its implementing regulations, as amended, or HIPAA, that govern the collection, use, disclosure, and protection of health-related and other personal information. In California the California Consumer Protection Act, or CCPA, which went into effect on January 1, 2020 and was amended effective January 1, 2023, establishes a new privacy framework for covered businesses by creating an expanded definition of personal information, establishing new data privacy rights for consumers in the State of California, imposing special rules on the collection of consumer data from minors, and

 

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creating a new and potentially severe statutory damages framework for violations of the CCPA and for businesses that fail to implement reasonable security procedures and practices to prevent data breaches. While clinical trial data and information governed by HIPAA are currently exempt from the current version of the CCPA, other personal information may be applicable and possible changes to the CCPA may broaden its scope. Other states, including Virginia (effective January 1, 2023), Colorado (effective July 1, 2023), Connecticut (effective July 1, 2023), and Utah (effective December 31, 2023) have passed privacy legislation and more states may do so in the future, including Iowa, where the Iowa state legislature passed a comprehensive privacy legislation on March 15, 2023. State and non-U.S. laws, including for example the EU General Data Protection

Regulation, also govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. Failure to comply with these laws, where applicable, can result in the imposition of significant civil and/or criminal penalties and private litigation. Privacy and security laws, regulations, and other obligations are constantly evolving, may conflict with each other to complicate compliance efforts, and can result in investigations, proceedings, or actions that lead to significant civil and/or criminal penalties and restrictions on data processing.

Coverage and Reimbursement

In the United States and markets in other countries, patients generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Adequate coverage and reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors is critical to new product acceptance. Our ability to successfully commercialize its product candidates will depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from government health administration authorities, private health insurers and other organizations. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow it to establish or maintain pricing sufficient to realize a sufficient return on its investment. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which medications they will pay for and establish reimbursement levels.

Significant uncertainty exists as to the coverage and reimbursement status of any pharmaceutical or biological product for which we obtain regulatory approval. Sales of any product, if approved, depend, in part, on the extent to which such product will be covered by third-party payors, such as federal, state, and foreign government healthcare programs, commercial insurance and managed healthcare organizations, and the level of reimbursement, if any, for such product by third-party payors. Decisions regarding whether to cover any of its product candidates, if approved, the extent of coverage and amount of reimbursement to be provided are made on a plan-by-plan basis. Further, no uniform policy for coverage and reimbursement exists in the United States, and coverage and reimbursement can differ significantly from payor to payor. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement rates, but also have their own methods and approval process apart from Medicare determinations. As a result, the coverage determination process is often a time-consuming and costly process that will require it to provide scientific and clinical support for the use of its product candidates to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. Factors payors consider in determining reimbursement are based on whether the product is:

 

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a covered benefit under its health plan;

 

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safe, effective and medically necessary;

 

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appropriate for the specific patient;

 

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cost-effective; and

 

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neither experimental nor investigational.

Third-party payors are increasingly challenging the prices charged for medical products and services, examining the medical necessity and reviewing the cost effectiveness of pharmaceutical or biological products,

 

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medical devices and medical services, in addition to questioning safety and efficacy. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit sales of any product that receives approval. Decreases in third-party reimbursement for any product or a decision by a third-party not to cover a product could reduce physician usage and patient demand for the product.

For products administered under the supervision of a physician, obtaining coverage and adequate reimbursement may be particularly difficult because of the higher prices often associated with such drugs. Additionally, separate reimbursement for the product itself or the treatment or procedure in which the product is used may not be available, which may impact physician utilization. In addition, companion diagnostic tests require coverage and reimbursement separate and apart from the coverage and reimbursement for their companion pharmaceutical or biological products. Similar challenges to obtaining coverage and reimbursement, applicable to pharmaceutical or biological products, will apply to companion diagnostics.

In addition, net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States. Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products. We cannot be sure that reimbursement will be available for any product candidate that it commercializes and, if reimbursement is available, the level of reimbursement. In addition, many pharmaceutical manufacturers must calculate and report certain price reporting metrics to the government, such as average sales price, or ASP, and best price. Penalties may apply in some cases when such metrics are not submitted accurately and timely. Further, these prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs.

Finally, in some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing vary widely from country to country. For example, the European Union, or EU, provides options for its member states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost effectiveness of a particular product candidate to currently available therapies. A member state may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of its product candidates. Historically, products launched in the EU do not follow price structures of the U.S. and generally prices tend to be significantly lower.

Healthcare Reform

The United States and some foreign jurisdictions are considering or have enacted a number of reform proposals to change the healthcare system. There is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by federal and state legislative initiatives, including those designed to limit the pricing, coverage, and reimbursement of pharmaceutical and biopharmaceutical products, especially under government-funded health care programs, and increased governmental control of drug pricing.

The ACA, which was enacted in 2010, substantially changed the way healthcare is financed by both governmental and private insurers in the United States, and significantly affected the pharmaceutical industry. The ACA contains a number of provisions of particular import to the pharmaceutical and biotechnology

 

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industries, including, but not limited to, those governing enrollment in federal healthcare programs. Since its enactment, there have been judicial and Congressional challenges to certain aspects of the ACA, and we expect there will be additional challenges and amendments to the ACA in the future.

Other legislative changes have been proposed and adopted since the ACA was enacted. For example, on March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, beginning January 1, 2024. The Budget Control Act of 2011 and subsequent legislation, among other things, created measures for spending reductions by Congress that include aggregate reductions of Medicare payments to providers of 2% per fiscal year, which remain in effect through 2031. Due to the Statutory Pay-As-You-Go Act of 2010, estimated budget deficit increases resulting from the American Rescue Plan Act of 2021, and subsequent legislation, Medicare payments to providers will be further reduced starting in 2025 absent further legislation. The U.S. American Taxpayer Relief Act of 2012 further reduced Medicare payments to several types of providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

In addition, the Bipartisan Budget Act of 2018, among other things, amended the Medicare Act (as amended by the ACA) to increase the point-of-sale discounts that manufacturers must agree to offer under the Medicare Part D coverage discount program to 70% off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs being covered under Medicare Part D. Further, on May 30, 2018, the Right to Try Act, was signed into law. The law, among other things, provides a federal framework for certain patients to access certain investigational new drug products that have completed a Phase 1 clinical trial and that are undergoing investigation for FDA approval. Under certain circumstances, eligible patients can seek treatment without enrolling in clinical trials and without obtaining FDA permission under the FDA expanded access program. There is no obligation for a pharmaceutical manufacturer to make its drug products available to eligible patients as a result of the Right to Try Act.

Moreover, there has recently been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state measures designed to, among other things, reduce the cost of prescription drugs, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. For example, in May 2019, CMS adopted a final rule allowing Medicare Advantage Plans the option to use step therapy for Part B drugs, permitting Medicare Part D plans to apply certain utilization controls to new starts of five of the six protected class drugs, and requiring the Explanation of Benefits for Part D beneficiaries to disclose drug price increases and lower cost therapeutic alternatives.

In addition, the U.S. government, state legislatures and foreign governments have continued implementing cost-containment programs, including price controls, restrictions on coverage and reimbursement and requirements for substitution of generic products. The IRA includes several provisions that may impact our business to varying degrees, including provisions that reduce the out-of-pocket spending cap for Medicare Part D beneficiaries from $7,050 to $2,000 starting in 2025, thereby effectively eliminating the coverage gap; impose new manufacturer financial liability on certain drugs under Medicare Part D, allow the U.S. government to negotiate Medicare Part B and Part D price caps for certain high-cost drugs and biologics without generic or biosimilar competition; require companies to pay rebates to Medicare for certain drug prices that increase faster than inflation; and delay until January 1, 2032 the implementation of the HHS rebate rule that would have limited the fees that pharmacy benefit managers can charge. Further, under the IRA, orphan drugs are exempted from the Medicare drug price negotiation program, but only if they have one rare disease designation and for which the only approved indication is for that disease or condition. If a product receives multiple rare disease designations or has multiple approved indications, it may not qualify for the orphan drug exemption. The implementation of the IRA is currently subject to ongoing litigation challenging the constitutionality of the IRA’s Medicare drug price negotiation program. The effects of the IRA on its business and the healthcare industry in general is not yet known.

 

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President Biden has also issued multiple executive orders that have sought to reduce prescription drug costs. In February 2023, HHS also issued a proposal in response to an October 2022 executive order from President Biden that includes a proposed prescription drug pricing model that will test whether targeted Medicare payment adjustments will sufficiently incentivize manufacturers to complete confirmatory trials for drugs approved through FDA’s accelerated approval pathway. Although a number of these and other proposed measures may require authorization through additional legislation to become effective, and the Biden administration may reverse or otherwise change these measures, both the Biden administration and Congress have indicated that they will continue to seek new legislative measures to control drug costs.

Notwithstanding the IRA and President Biden’s executive orders, continued legislative and enforcement interest exists in the United States with respect to specialty drug pricing practices. Specifically, we expect regulators to continue pushing for transparency to drug pricing, reducing the cost of prescription drugs under Medicare, reviewing the relationship between pricing and manufacturer patient programs, and reforming government program reimbursement methodologies for drugs.

Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain drug access and marketing cost disclosure and transparency measures, and designed to encourage importation from other countries and bulk purchasing. Legally mandated price controls on payment amounts by third-party payors or other restrictions could harm our business, financial condition, results of operations and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce the ultimate demand for its drugs or put pressure on its drug pricing, which could negatively affect our business, financial condition, results of operations and prospects.

Other Government Regulation Outside of the United States

Regulation Outside of the United States

EU Drug Development

In addition to regulations in the United States, we are subject to a variety of regulations in other jurisdictions governing clinical studies, commercial sales, and distribution of our products. Most countries outside of the United States require that clinical trial applications be submitted to and approved by the local regulatory authority for each clinical study. In the EU, for example, an application must be submitted to the national competent authority and an independent ethics committee in each country in which we intend to conduct clinical trials, much like the FDA and IRB, respectively. Under the new Clinical Trials Regulation (EU) No 536/2014, which replaced the Clinical Trials Directive 2001/20/EC on January 31, 2022, a single application is now made through the Clinical Trials Information System for clinical trial authorization in up to 30 EU/EEA countries at the same time and with a single set of documentation.

The assessment of applications for clinical trials is divided into two parts (Part I contains scientific and medicinal product documentation and Part II contains the national and patient-level documentation). Part I is assessed by a coordinated review by the competent authorities of all EU Member States in which an application for authorization of a clinical trial has been submitted (Member States Concerned) of a draft report prepared by a Reference Member State. Part II is assessed separately by each Member State Concerned. The role of the relevant ethics committees in the assessment procedure will continue to be governed by the national law of the Member State Concerned, however overall related timelines are defined by the Clinical Trials Regulation. The new Clinical Trials Regulation also provides for simplified reporting procedures for clinical trial sponsors.

EU Drug Review and Approval

In addition, whether or not we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory authorities of countries outside the United States before we can commence marketing

 

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of the product in those countries. The approval process and requirements vary from country to country, so the number and type of nonclinical, clinical, and manufacturing studies needed may differ, and the time may be longer or shorter than that required for FDA approval.

To obtain regulatory approval for our medicinal products under the EU regulatory system, a marketing authorization application, or MAA, needs to be submitted. There are a number of potential routes open to obtain a marketing authorization, or MA. The centralized procedure allows applicants to obtain a MA that is valid throughout the EU, and the additional Member States of the European Economic Area (Iceland, Liechtenstein and Norway), or EEA. It is compulsory for medicinal products manufactured using biotechnological processes, orphan medicinal products, advanced therapy medicinal products (gene-therapy, somatic cell-therapy or tissue-engineered medicines) and human products containing a new active substance which is not authorized in the EU and which is intended for the treatment of HIV, AIDS, cancer, neurodegenerative disorders, auto-immune and other immune dysfunctions, viral diseases or diabetes. The centralized procedure is optional for any other products containing new active substances not authorized in the EU or for products which constitute a significant therapeutic, scientific, or technical innovation or for which a centralized authorization is in the interests of patients at EU level. When a company wishes to place on the market a medicinal product that is eligible for the centralized procedure, it sends an application directly to the European Medicines Agency, or EMA, to be assessed by the Committee for Medicinal Products for Human Use, or CHMP. The CHMP is responsible for conducting the assessment of whether a medicine meets the required quality, safety, and efficacy requirements, and whether the product has a positive risk/benefit profile. The procedure results in a European Commission decision, which is valid in all EU Member States. The centralized procedure is as follows: full copies of the MAA are sent to a rapporteur and a co-rapporteur designated by the competent EMA scientific committee. They coordinate the EMA’s scientific assessment of the medicinal product and prepare draft reports. Once the draft reports are prepared (other experts might be called upon for this purpose), they are sent to the CHMP, whose comments or objections are communicated to the applicant. The rapporteur acts as an EMA contact person for the applicant and continues to play this role, even after the MA has been granted.

The rapporteur and co-rapporteur then assess the applicant’s replies, submit them for discussion to the CHMP, and taking into account the conclusions of this debate, prepare a final assessment report. Once the evaluation is completed, the CHMP gives a favorable or unfavorable opinion as to whether to grant the authorization. When the opinion is favorable, it shall include the draft summary of product characteristics, or SmPC, the package leaflet, and the texts proposed for the various packaging materials. The time limit for the evaluation procedure is 210 days (excluding clock stops, when additional written or oral information is to be provided by the applicant in response to questions asked by the CHMP). The EMA then has fifteen days to forward its opinion to the European Commission, which will make a binding decision on the grant of an MA within 67 days of the receipt of the CHMP opinion.

There are two other procedures in the EU for the grant of an MA in multiple EU Member States. The decentralized procedure provides for approval by one or more other, or Concerned Member States, of an assessment of an application performed by one Member State, known as the Reference Member State. Under this procedure, an applicant submits an application, or dossier, and related materials including a draft SmPC, and draft labeling and package leaflet, to the Reference Member State and Concerned Member States. The Reference Member State prepares a draft assessment and drafts of the related materials within 120 days after receipt of a valid application. Within 90 days of receiving the Reference Member State’s assessment report, each Concerned Member State must decide whether to approve the assessment report and related materials. If a Member State cannot approve the assessment report and related materials on the grounds of potential serious risk to the public health, the disputed points may eventually be referred to the European Commission, whose decision is binding on all Member States. Where a product has already been authorized for marketing in a EU Member State, this national MA can be recognized in other Member States through the mutual recognition procedure.

EU New Chemical Entity Exclusivity

In the EU, innovative medicinal products approved on the basis of a complete and independent data package qualify for eight years of data exclusivity upon marketing authorization and an additional two years of market

 

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exclusivity. The data exclusivity, if granted, prevents generic or biosimilar applicants from referencing the innovator’s preclinical and clinical trial data contained in the dossier of the reference product when applying for a generic or biosimilar MA in the EU, during a period of eight years from the date on which the reference product was first authorized in the EU. During the additional two-year period of market exclusivity, a generic or biosimilar MAA can be submitted, and the innovator’s data may be referenced, but no generic or biosimilar product can be placed on the EU market until the expiration of the market exclusivity. The overall ten-year period will be extended to a maximum of 11 years if, during the first eight years of those ten years, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are determined to bring a significant clinical benefit in comparison with currently approved therapies. There is no guarantee that a product will be considered by the EMA to be an innovative medicinal product, and products may not qualify for data exclusivity. Even if a product is considered to be an innovative medicinal product so that the innovator gains the prescribed period of data exclusivity, however, another company could nevertheless also market another version of the product if such company obtained an MA based on an MAA with a complete and independent data package of pharmaceutical tests, preclinical tests and clinical trials.

EU Orphan Designation and Exclusivity

The criteria for designating an “orphan medicinal product” in the EU are similar in principle to those in the United States. Under Article 3 of Regulation (EC) 141/2000, a medicinal product may be designated as an orphan medicinal product if it is intended for the diagnosis, prevention, or treatment of a life-threatening or chronically debilitating condition that affects no more than five in 10,000 persons in the EU when the application is made. In addition, orphan designation can be granted if the product is intended for a life threatening, seriously debilitating, or serious and chronic condition in the EU and, without incentives, it is unlikely that sales of the product in the EU would be sufficient to justify the necessary investment in its development. Orphan designation is only available if there is no other satisfactory method approved in the EU of diagnosing, preventing, or treating the applicable orphan condition, or if such a method exists, the proposed orphan medicinal product will be of significant benefit to patients affected by such condition, as defined in Regulation (EC) 847/2000.

Orphan designation provides opportunities for fee reductions, protocol assistance, and access to the centralized procedure. Fee reductions are limited to the first year after an MA, except for small and medium enterprises. In addition, if a product which has an orphan designation subsequently receives a centralized MA for the indication for which it has such designation, the product is entitled to orphan market exclusivity, which means the EMA may not approve any other application to market a similar medicinal product for the same indication for a period of ten years. A “similar medicinal product” is defined as a medicinal product containing a similar active substance or substances as contained in an authorized orphan medicinal product, and which is intended for the same therapeutic indication. The exclusivity period may be reduced to six years if, at the end of the fifth year, it is shown that the designation criteria are no longer met, including where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity. Additionally, an MA may be granted to a similar medicinal product for the same indication at any time if:

 

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the second applicant can establish that its product, although similar to the authorized product, is safer, more effective or otherwise clinically superior;

 

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the MA holder of the authorized product consents to a second orphan medicinal product application; or

 

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the MA holder of the authorized product cannot supply enough orphan medicinal product.

EU Pediatric Investigation Plan

A pediatric investigation plan, or PIP, in the EU is aimed at ensuring that the necessary data are obtained to support the authorization of a medicine for children, through studies in children. All applications for MAs for new medicines have to include the results of studies as described in an agreed PIP, unless the medicine is exempt because of a deferral or waiver. This requirement also applies when an MA holder wants to add a new indication,

 

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pharmaceutical form, or route of administration for a medicine that is already authorized and covered by intellectual property rights. Several rewards and incentives for the development of pediatric medicines for children are available in the EU. Medicines authorized across the EU with the results of studies from a PIP included in the product information are eligible for an extension of their supplementary protection certificate, or SPC, by six months (provided an application for such extension is made at the same time as filing the SPC application for the product, or at any point up to two years before the SPC expires). This is the case even when the studies’ results are negative. For orphan medicinal products, the incentive is an additional two years of market exclusivity. Scientific advice and protocol assistance at the EMA are free of charge for questions relating to the development of pediatric medicines. Medicines developed specifically for children that are already authorized but are not protected by a patent or supplementary protection certificate are eligible for a pediatric-use MA, or PUMA. If a PUMA is granted, the product will benefit from ten years of market protection as an incentive.

PRIME Scheme

In March 2016, the EMA launched an initiative, the PRIority Medicines, or PRIME, scheme, to facilitate development of product candidates in indications, often rare, for which few or no therapies currently exist. The PRIME scheme is intended to encourage development of products in areas of unmet medical need and provides accelerated assessment of products representing substantial innovation reviewed under the centralized procedure. Products from small- and medium-sized enterprises may qualify for earlier entry into the PRIME scheme than larger companies on the basis of compelling non-clinical data and tolerability data from initial clinical trials. Many benefits accrue to sponsors of product candidates with PRIME designation, including but not limited to, early and proactive regulatory dialogue with the EMA, frequent discussions on clinical trial designs and other development program elements, and potentially accelerated MAA assessment once a dossier has been submitted. Importantly, once a candidate medicine has been selected for the PRIME scheme, a dedicated contact and rapporteur from the CHMP or from the Committee for Advanced Therapies, or CAT, are appointed early in the PRIME scheme facilitating increased understanding of the product at the EMA’s committee level. An initial meeting with the CHMP/CAT rapporteur initiates these relationships and includes a team of multidisciplinary experts at the EMA to provide guidance on the overall development and regulatory strategies. PRIME eligibility does not change the standards for product approval, and there is no assurance that any such designation or eligibility will result in expedited review or approval.

The aforementioned EU rules are generally applicable in the EEA.

Reform of the Regulatory Framework in the EU

The European Commission introduced legislative proposals in April 2023, that if implemented, will replace the current regulatory framework in the EU for all medicines (including those for rare diseases and for children). The European Commission has provided the legislative proposals to the European Parliament and the European Council for their review and approval. The European Parliament and the European Council may propose amendments to the proposals. Once the proposals are approved (with or without amendment), they will be adopted into EU law.

Brexit and the Regulatory Framework in the United Kingdom

The United Kingdom left the EU on January 31, 2020, and the United Kingdom and the EU have concluded a trade and cooperation agreement, or TCA, which was provisionally applicable since January 1, 2021 and has been formally applicable since May 1, 2021.

The TCA includes specific provisions concerning pharmaceuticals, which include the mutual recognition of GMP, inspections of manufacturing facilities for medicinal products and GMP documents issued, but does not provide for wholesale mutual recognition of United Kingdom and EU pharmaceutical regulations. At present, Great Britain has implemented EU legislation on the marketing, promotion and sale of medicinal products through the

 

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Human Medicines Regulations 2012 (as amended). Except in respect of the new EU Clinical Trials Regulation, the regulatory regime in Great Britain therefore largely aligns with current EU medicines regulations, however it is possible that these regimes will diverge more significantly in future now that Great Britain’s regulatory system is independent from the EU and the TCA does not provide for mutual recognition of United Kingdom and EU pharmaceutical legislation. However, notwithstanding that there is no wholesale recognition of EU pharmaceutical legislation under the TCA, under a new framework mentioned below which will be put in place by the Medicines and Healthcare products Regulatory Agency, or MHRA, the United Kingdom’s medicines regulator, from January 1, 2024, the MHRA has stated that it will take into account decisions on the approval of MAs from the EMA (and certain other regulators) when considering an application for a Great Britain MA.

On February 27, 2023, the United Kingdom government and the European Commission announced a political agreement in principle to replace the Northern Ireland Protocol with a new set of arrangements, known as the “Windsor Framework”. This new framework fundamentally changes the existing system under the Northern Ireland Protocol, including with respect to the regulation of medicinal products in the United Kingdom. In particular, the MHRA will be responsible for approving all medicinal products destined for the United Kingdom market (i.e., Great Britain and Northern Ireland), and the EMA will no longer have any role in approving medicinal products destined for Northern Ireland. A single United Kingdom-wide MA will be granted by the MHRA for all medicinal products to be sold in the United Kingdom, enabling products to be sold in a single pack and under a single authorization throughout the United Kingdom. The Windsor Framework was approved by the EU-United Kingdom Joint Committee on March 24, 2023, so the United Kingdom government and the EU will enact legislative measures to bring it into law. On June 9, 2023, the MHRA announced that the medicines aspects of the Windsor Framework will apply from January 1, 2025.

The MHRA has introduced changes to national licensing procedures, including procedures to prioritize access to new medicines that will benefit patients, an accelerated assessment procedure and new routes of evaluation for novel products and biotechnological products. All existing EU MAs for centrally authorized products were automatically converted (grandfathered) into United Kingdom MAs free of charge on January 1, 2021. For a period of three years from January 1, 2021, the MHRA may rely on a decision taken by the European Commission on the approval of a new MA in the centralized procedure, in order to more quickly grant a new Great Britain MA. A separate application will, however, still be required. On January 24, 2023, the MHRA announced that a new international recognition framework will be put in place from January 1, 2024, which will have regard to decisions on the approval of MAs made by the EMA and certain other regulators when determining an application for a new Great Britain MA. There is now no pre-MA orphan designation in Great Britain. Instead, the MHRA reviews applications for orphan designation in parallel to the corresponding MAA. The criteria are essentially the same, but have been tailored for the Great Britain market, i.e., the prevalence of the condition in Great Britain (rather than the EU) must not be more than five in 10,000. Should an orphan designation be granted, the period of market exclusivity will be set from the date of first approval of the product in Great Britain.

Human Capital

As of November 30, 2023, Q32 had 34 full-time employees, of which 7 have M.D. or Ph.D. degrees. Within Q32’s workforce, 25 employees are engaged in research and development and 9 are engaged in general management and administration. None of Q32’s employees are represented by labor unions or covered by collective bargaining agreements. Q32 considers its relationship with its employees to be good.

Q32’s human capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating Q32’s existing and new employees, advisors and consultants. The principal purposes of Q32’s equity incentive plans are to attract, retain and reward personnel through the granting of equity-based compensation awards in order to increase shareholder value and the success of Q32’s company by motivating such individuals to perform to the best of their abilities and achieve Q32’s objectives.

 

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Facilities

Q32’s principal office is located at 830 Winter Street, Waltham, Massachusetts 02451, where Q32 leases approximately 15,771 square feet of office space. The lease term began in January 2022 and will end in December 2031. Q32 believes that this facility will be adequate to meet Q32’s near-term needs. If required, Q32 believes that suitable additional or substitute space will be available in the future on commercially reasonable terms to accommodate any such expansion Q32’s operations.

Legal Proceedings

From time to time, Q32 may become involved in legal proceedings arising from the ordinary course of business. Q32 records a liability for such matters when it is probable that future losses will be incurred and that such losses can be reasonably estimated.

 

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HOMOLOGY MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion and analysis of Homology’s financial condition and results of operations together with the section titled “Unaudited Pro Forma Combined Financial Data” and Homology’s consolidated financial statements and related notes included elsewhere in this proxy statement/prospectus. This discussion and other parts of this proxy statement/prospectus contain forward-looking statements that involve risks and uncertainties, such as its plans, objectives, expectations, intentions, and beliefs. Homology’s actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those discussed in the section titled “Risk Factors—Risks Related to Homology’s Business” included elsewhere in this proxy statement/prospectus.

Overview

Homology is a clinical-stage genetic medicines company historically focused on transforming the lives of patients suffering from rare genetic diseases with significant unmet medical needs by addressing the underlying cause of the disease. Homology’s proprietary platform is designed to utilize its human hematopoietic stem cell-derived adeno-associated virus vectors, or AAVHSCs, to precisely and efficiently deliver single administration genetic medicines in vivo through a nuclease-free gene editing modality, gene therapy, or gene therapy to express antibodies platform, or GTx-mAb, which is designed to produce antibodies throughout the body.

In July 2023, Homology completed a review of its business and its Board of Directors approved a plan to explore, review and evaluate a range of potential strategic options available to it, including, without limitation, an acquisition, merger, reverse merger, sale of assets, strategic partnerships or other transactions. Based on the financing environment and the anticipated clinical development timeline for its lead program, HMI-103, Homology stopped further development of its programs and reduced its workforce by 86% to significantly reduce its ongoing operating costs as it evaluates strategic alternatives.

After a comprehensive review of strategic alternatives, on November 16, 2023, Homology entered into an Agreement and Plan of Merger, or the Merger Agreement, with Q32 Bio Inc., a Delaware corporation, or Q32, and Kenobi Merger Sub, Inc., a Delaware corporation and Homology’s direct, wholly owned subsidiary, or Merger Sub, pursuant to which, among other matters, and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, Merger Sub will merge with and into Q32, with Q32 continuing as Homology’s wholly owned subsidiary and the surviving corporation of the merger, or the Merger. Homology’s future operations are highly dependent on the success of the Merger and there can be no assurance that the Merger will be successfully consummated.

Homology’s former clinical programs include: HMI-103, an investigational gene editing candidate for the treatment of patients with phenylketonuria, or PKU, HMI-203, an investigational gene therapy candidate for the treatment of patients with mucopolysaccharidosis type II (MPS II), or Hunter syndrome and HMI-102, an investigational gene therapy candidate for the treatment of adult patients with PKU. Homology’s former preclinical programs include: HMI-104, a GTx-mAb gene therapy candidate for the treatment of patients with paroxysmal nocturnal hemoglobinuria, or PNH, and HMI-204, a gene therapy candidate for metachromatic leukodystrophy, or MLD. Homology is currently exploring strategic alternatives for HMI-103 (Adult/Pediatric PKU), HMI-204 (MLD) and Capsids and AAVHSC Platform, including the sale of these programs.

In September 2023, Homology withdrew its IND for HMI-102 (Adult PKU), which the FDA formally acknowledged in November 2023. Also in September 2023, Homology requested that the FDA place its HMI-103 (Adult/Pediatric PKU) and HMI-203 (Hunter Syndrome) programs on inactive status, which requests remain pending. Homology withdrew its IND for HMI-203 in December 2023. In August 2023, Homology withdrew its CTA for HMI-203 in Canada. All clinical trial sites have been notified that all studies conducted by Homology

 

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for its programs have been terminated and have been duly notified of their responsibilities. Homology has also withdrawn all orphan drug designations for its programs in both the United States and the EU.

HMI-103: Gene Editing Candidate for the Treatment of Patients with PKU

In September 2023, Homology inactivated its pheEDIT Phase 1 gene editing clinical trial evaluating HMI-103 in adults with classical PKU (NCT05222178). In October 2023, Homology reported clinical data from the first dose cohort in the pheEDIT trial. As of the data cut-off date of September 14, 2023, HMI-103 was generally well-tolerated in all three participants with no serious adverse events, and the majority of treatment-related adverse events were mild and transient. All liver function tests remained in the normal range during the prophylactic immunosuppression regimen incorporating the T-cell inhibitor tacrolimus in combination with corticosteroid. Participant 1 experienced a reduction in plasma phenylalanine, or Phe, levels to below the U.S. American College of Medical Genetics and Genomics PKU treatment guideline threshold of <360 µmol/L, and the majority of Phe levels were below 360 µmol/L through 39 weeks post-dose, including after the initiation of dietary protein supplementation. Participant 2 experienced a meaningful plasma Phe reduction of 50% at 23 weeks post-dose. Participant 3 experienced a meaningful plasma Phe reduction of 60% at 14 weeks post-dose.

In August 2023, Homology terminated both its pheNIX Phase 1/2 gene therapy clinical trial evaluating HMI-102 in adults with classical PKU and its juMPStart Phase 1 gene therapy clinical trial evaluating HMI-203 in adults with Hunter Syndrome. INDs for both the pheNIX Phase 1/2 and juMPStart Phase 1 clinical trials have been withdrawn.

Earlier-Stage Product Candidates

Homology completed IND-enabling studies with HMI-202, an investigational gene therapy for the treatment of patients with MLD. Applying the learnings from these IND-enabling studies, in August 2022, Homology announced the details of HMI-204, an optimized, in vivo, one-time gene therapy product candidate for the treatment of MLD. Following a single I.V. administration in the MLD murine model, this optimized candidate, which uses one of Homology’s proprietary AAVHSC capsids, crossed the blood-brain-barrier to the CNS and reached key peripheral organs involved in MLD. This resulted in expression of human ARSA, or hARSA, levels in multiple brain regions and cell types above the minimum level of enzyme needed to correct the MLD disease phenotype, hARSA activity levels in the brain predictive of functional assay improvements and hARSA activity in the serum. Additionally, these optimizations led to significant improvements in vector yield and superior packaging for the product candidate.

HMI-104 is a clinical development candidate for PNH from Homology’s GTx-mAb platform. This platform represents an additional way that Homology could potentially leverage its AAVHSCs in an effort to deliver one-time in vivo gene therapy to express and secrete antibodies from the liver, which it believes may allow it to target diseases with larger patient populations. In support of this program, Homology generated and presented preclinical data targeting complement protein 5, demonstrating preclinical proof-of-concept in PNH. A single I.V. dose of an AAVHSC GTx-mAb showed expression of full-length antibodies from the liver consistent with levels associated with anti-C5 therapeutics, sustained and robust Immunoglobulin G, or IgG, expression in vivo in a humanized murine liver model and a murine NOD-SCID model, and in vivo vector-expressed C5 mAb had potent functional activity as shown by an ex vivo hemolysis assay. Additionally, Homology observed sustained expression of C5 mAb in the presence of murine and human neonatal fragment crystallizable (Fc) receptor, or FcRn. Homology has completed IND-enabling studies with HMI-104.

Oxford Biomedica Solutions Transaction

On March 10, 2022, Homology closed a transaction with Oxford Biomedica Solutions LLC (f/k/a Roadrunner Solutions LLC), or OXB Solutions, Oxford Biomedica (US), Inc., or OXB, and Oxford Biomedica plc, or OXB Parent, and collectively with OXB, Oxford, pursuant to the Equity Securities Purchase Agreement, or the Purchase Agreement, dated as of January 28, 2022, by and among Homology, OXB Solutions and Oxford,

 

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whereby, among other things, Homology and Oxford agreed to collaborate to operate OXB Solutions, which provides AAV vector process development and manufacturing services to biotechnology companies, which Homology refers to as the Oxford Biomedica Solutions Transaction, or the OXB Solutions Transaction. OXB Solutions incorporates its proven ‘plug and play’ process development and manufacturing platform, as well as its experienced team and high-quality GMP vector production capabilities that Homology built and operated since 2019.

Pursuant to the terms of the Purchase Agreement and a contribution agreement, or the Contribution Agreement, entered into between Homology and OXB Solutions prior to the closing of the OXB Solutions Transaction, or the Closing, Homology agreed to assign and transfer to OXB Solutions all of its assets that are primarily used in the manufacturing of AAV vectors for use in gene therapy or gene editing products, but excluding certain assets related to manufacturing or testing of its proprietary AAV vectors, or collectively, the Transferred Assets, in exchange for 175,000 common equity units in OXB Solutions, or Units, and OXB Solutions assumed from Homology, and agreed to pay, perform and discharge when due, all of its duties, obligations, liabilities, interests and commitments of any kind under, arising out of or relating to the Transferred Assets.

Effective as of the Closing, Homology sold to OXB, and OXB purchased from Homology, 130,000 Units, or the Transferred Units, in exchange for $130.0 million. In connection with the Closing, OXB contributed $50.0 million in cash to OXB Solutions in exchange for an additional 50,000 Units. Immediately following the Closing, (i) OXB owned 180,000 Units, representing 80 percent (80%) of the fully diluted equity interests in OXB Solutions, and (ii) Homology owned 45,000 Units, representing 20 percent (20%) of the fully diluted equity interests in OXB Solutions.

Pursuant to the Amended and Restated Limited Liability Company Agreement of OXB Solutions, or the OXB Solutions Operating Agreement, which was executed in connection with the Closing, at any time following the three-year anniversary of the Closing, (i) OXB will have an option to cause Homology to sell and transfer to OXB, and (ii) Homology will have an option to cause OXB to purchase from Homology, in each case all of its equity ownership interest in OXB Solutions at a price equal to 5.5 times the revenue for the immediately preceding 12-month period, subject to a maximum amount of $74.1 million. Pursuant to the terms of the OXB Solutions Operating Agreement, Homology is entitled to designate one director on the board of directors of OXB Solutions, currently Paul Alloway, Ph.D., Homology’s President and Chief Operating Officer.

Concurrently with the Closing, Homology entered into certain ancillary agreements with OXB Solutions including a license and patent management agreement whereby OXB Solutions granted certain licenses to us, a supply agreement, or the Supply Agreement, for a term of three years which includes certain annual minimum purchase commitments, a lease assignment pursuant to which Homology assigned all of its right, title and interest in, to and under its facility lease to OXB Solutions, a sublease agreement whereby OXB Solutions subleased certain premises in its facility to Homology, as well as several additional ancillary agreements.

Corporate Headquarters Lease

In November 2021, Homology entered into an amendment of its December 2017 lease agreement, or the Lease Amendment, for its corporate headquarters in Bedford, Massachusetts. The Lease Amendment increases the space under the lease by approximately 23,011 square feet, or the Expansion Premises, and extends the expiration date of the existing premises under the lease from February 2027 to June 2030. The term with respect to the Expansion Premises commenced on May 1, 2022 and continues for a period of ten years and five months. The term of the Expansion Premises and the existing premises are not coterminous. Annual base rent for the existing premise under the Lease Amendment is approximately $4.7 million beginning on March 1, 2027, and increases by three percent annually; annual base rent for the Expansion Premises is approximately $1.4 million per year and increases by three percent annually. The Lease Amendment allows for tenant improvement allowances not to exceed $6.3 million in the aggregate. Under the terms of the agreement with Oxford,

 

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Homology’s lease for its corporate headquarters, including the Expansion Premises, has been assigned to OXB Solutions with Homology subleasing a portion of lab and office space back from the newly created company until December 31, 2024. Homology was released from being primary obligor under such lease, effective as of October 1, 2023. See Notes 9 and 13 to Homology’s condensed consolidated financial statements included elsewhere in this proxy statement/prospectus for additional information regarding Homology’s lease agreement.

License Agreements

In April 2016, Homology entered into an exclusive license agreement with City of Hope, or COH, pursuant to which COH granted Homology an exclusive, sublicensable, worldwide license, or the COH License, to certain AAV vector-related patents and know-how owned by COH to develop, manufacture, use and commercialize products and services covered by such patents and know-how in any and all fields. On August 6, 2021, Homology received notice from COH that Homology did not accomplish at least one of the partnering milestones by the applicable deadline, as set forth in the COH License. This notice does not affect its exclusive license in the field of mammalian therapeutics, including all human therapeutics, associated diagnostics, and target validation, or the Mammalian Therapeutic Field, where Homology retains exclusive rights. Instead, the notice served as written notice that the exclusive license granted pursuant to the COH License in all fields except the Mammalian Therapeutic Field converted from exclusive to non-exclusive effective as of September 20, 2021, which was forty-five days from the receipt of notice. In connection with the conversion, any royalty obligations and sublicensee fees relating to fields outside of the Mammalian Therapeutic Field shall be reduced by a certain percentage. This change to Homology’s exclusive worldwide license with COH does not impact any of its therapeutic product development candidates, including HMI-102, HMI-103, HMI-104, HMI-203 and HMI-204.

Financial Overview

Since its inception in 2015 through September 30, 2023, Homology has raised approximately $721 million in aggregate net proceeds through its initial public offering, or IPO, in April 2018, follow-on public offerings of common stock in April 2019 and April 2021, proceeds from the sale of common stock under an “at-the-market” sales agreement, equity investments from pharmaceutical companies, preferred stock financings and its agreement with Oxford. Included in its net proceeds is a $130.0 million up-front cash payment from its agreement with Oxford, $50.0 million from a former collaboration partner, comprised of an up-front payment of $35.0 million and a $15.0 million equity investment, and a $60.0 million equity investment from Pfizer Inc., or Pfizer, through a private placement transaction. Should Homology resume development of one or more of its product candidates, it will require additional capital in order to advance its product candidates through clinical development and commercialization.

Homology was incorporated and commenced operations in 2015. Since its incorporation and until recently, Homology has devoted substantially all of its resources to organizing and staffing its Company, business planning, raising capital, developing its technology platform, advancing HMI-102, HMI-103 and HMI-203 through IND-enabling studies and into clinical trials, advancing HMI-202 and HMI-104 into IND-enabling studies, researching and identifying additional product candidates, developing and implementing manufacturing processes and manufacturing capabilities, building out its manufacturing and research and development space, enhancing its intellectual property portfolio and providing general and administrative support for these operations. To date, Homology has financed its operations primarily through the sale of common stock, through the sale of preferred stock, through funding from its collaboration partner and through proceeds received as a result of its transaction with OXB Solutions.

To date, Homology has not generated any revenue from product sales and does not expect to generate any revenue from the sale of products in the foreseeable future, if at all. Homology recognized $1.2 million in collaboration revenue for the nine months ended September 30, 2023, and $0.8 million and $2.4 million for the three and nine months ended September 30, 2022, respectively. Homology did not recognize any collaboration revenue for the three months ended September 30, 2023.

 

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Since inception, Homology has incurred significant operating losses. Homology’s net loss was $33.0 million and $96.8 million for the three and nine months ended September 30, 2023, respectively. For the three months ended September 30, 2022, its net loss was $33.7 million and for the nine months ended September 30, 2022, its net income was $29.3 million as a result of its transaction with OXB Solutions, as Homology recorded a gain of $131.2 million on the sale of its manufacturing business (see Note 5 to Homology’s condensed consolidated financial statements included elsewhere in this proxy statement/prospectus for additional information regarding the OXB Solutions Transaction). As of September 30, 2023 and December 31, 2022, Homology had an accumulated deficit of $526.0 million and $429.1 million, respectively.

Homology’s total operating expenses were $31.0 million and $90.5 million for the three and nine months ended September 30, 2023, respectively, and $33.7 million and $101.2 million for the three and nine months ended September 30, 2022, respectively. Homology expects operating expenses to continue to decrease over the prior year as Homology recently reduced its workforce by 86% and stopped all further program development efforts. Homology expects to continue to incur costs and expenditures in connection with activities related to the Merger and Homology will continue to incur costs associated with operating as a public company. There can be no assurance, however, that Homology will be able to successfully consummate the Merger. The process of evaluating strategic transactions has been and, if the Merger is not consummated, may continue to be costly, time-consuming and complex, and Homology may incur significant costs related to these processes, such as legal, accounting and advisory fees and expenses and other related charges. A considerable portion of these costs were and will continue to be incurred regardless of whether the Merger is completed. Such expenses decrease the remaining cash available for use in its business. Failure to consummate the Merger could significantly impair Homology’s ability to enter into any future strategic transactions and may significantly diminish or delay any future distributions to its stockholders.

Should Homology resume development of product candidates, its ability to generate product revenue sufficient to achieve profitability would depend heavily on the successful development and eventual commercialization of one or more product candidates. Homology’s future operating requirements will depend on many factors, including:

 

  •  

the costs, timing, and results of research and development efforts for any product candidates, including clinical trials;

 

  •  

the costs and timing of process development scale-up activities, and the adequacy of supply of any product candidates for preclinical studies and clinical trials through CMOs, including OXB Solutions;

 

  •  

the costs and timing of preparing, filing, and prosecuting patent applications, maintaining and enforcing its intellectual property rights and defending any intellectual property-related claims, including any claims by third parties that Homology is infringing upon their intellectual property rights;

 

  •  

the effect of competitors and market developments; and

 

  •  

its ability to establish and maintain strategic collaborations, licensing or other agreements and the financial terms of such agreements for its product candidates.

As of September 30, 2023, Homology had cash, cash equivalents, and short-term investments of $103.3 million. Based on its current projections, including its recent reduction in force and stopping further program development efforts, Homology believes that its existing cash, cash equivalents, and short-term investments will enable Homology to continue its operations for at least one year from the date of the filing of its Quarterly Report on Form 10-Q for the period ended September 30, 2023. However, due to the discontinuation of all of Homology’s clinical trials and research activities, as well as its recent reduction in force of all but a few custodial employees, Homology’s management has concluded that there is a substantial doubt regarding its ability to continue as a going concern for more than twelve months after the date the unaudited condensed consolidated financial statements included in its Quarterly Report on Form 10-Q for the period ended September 30, 2023 have been issued. See “Liquidity and Capital Resources.”

 

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Components of Homology’s Results of Operations

Revenue

To date, Homology has not generated any revenue from product sales and does not expect to generate any revenue from the sale of products in the foreseeable future. Homology recorded $1.2 million and $2.4 million in collaboration revenue for the nine months ended September 30, 2023 and 2022, respectively, related to the Stock Purchase Agreement with Pfizer (see Note 12 to Homology’s condensed consolidated financial statements included elsewhere in this proxy statement/prospectus for additional information regarding revenue recognition discussions).

Operating Expenses

Homology’s operating expenses since inception have consisted solely of research and development costs and general and administrative costs.

Research and Development Expenses

Research and development expenses consist primarily of costs incurred for research activities, including discovery efforts, and the development of its product candidates, and include:

 

  •  

salaries, benefits and other related costs, including stock-based compensation expense, for personnel engaged in research and development functions;

 

  •  

expenses incurred under agreements with third parties, including contract research organizations, or CROs, and other third parties that conduct research, preclinical activities and clinical trials on its behalf as well as CMOs, including OXB Solutions, that manufacture its product candidates for use in preclinical testing and clinical trials;

 

  •  

costs of outside consultants, including their fees and related travel expenses;

 

  •  

costs of laboratory supplies and acquiring, developing and manufacturing preclinical study and clinical trial materials; and

 

  •  

allocated expenses for rent and other operating costs.

Homology expenses research and development costs as incurred.

Research and development activities have historically been central to Homology’s business model. Homology expects its research and development expenses to continue to decrease significantly given the discontinuation of all of its clinical trials and research activities. Should Homology resume development of product candidates, Homology would expect research and development costs to increase significantly for the foreseeable future as the product candidate development programs progress.

Should Homology resume development of product candidates, the duration, costs and timing of development activities including clinical trials would depend on a variety of factors, including:

 

  •  

the scope, rate of progress, expense and results of clinical trials and other research and development activities that it may conduct;

 

  •  

uncertainties in clinical trial design and patient enrollment rates;

 

  •  

the actual probability of success for its product candidates, including the safety and efficacy results, early clinical data, competition, manufacturing capability and commercial viability;

 

  •  

significant and changing government regulation and regulatory guidance;

 

  •  

the timing and receipt of any marketing approvals; and

 

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  •  

the expense of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights.

Should Homology resume development of product candidates, a change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate. For example, if the FDA or another regulatory authority were to require Homology to conduct clinical trials beyond those that Homology anticipates will be required for the completion of clinical development of a product candidate, or if Homology experiences significant delays in its clinical trials due to patient enrollment or other reasons, Homology would be required to expend significant additional financial resources and time on the completion of clinical development.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in Homology’s executive, finance, human resources, legal, business development and administrative functions. General and administrative expenses also include legal fees relating to intellectual property and corporate matters; professional fees for accounting, auditing, tax and consulting services; insurance costs; travel expenses; and facility-related expenses, which include direct depreciation costs, rent expense, maintenance of facilities and other operating costs including expenses associated with being a public company.

Homology expects its general and administrative expenses to decrease in the near future due to its recent workforce reductions. Homology has incurred and expects to continue to incur significant costs, however, related to its exploration of strategic alternatives, including legal, accounting and advisory expenses and other related charges.

Other Income

Other income consists of a gain on the sale of Homology’s manufacturing business and interest income earned on its cash, cash equivalents, and short-term investments. Homology’s interest income has increased due to significantly higher yields on invested funds during the three and nine months ended September 30, 2023 as compared to the prior year.

Critical Accounting Policies and Use of Estimates

Homology’s management’s discussion and analysis of financial condition and results of operations is based on its condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of its condensed consolidated financial statements and related disclosures requires Homology to make estimates, assumptions and judgments that affect the reported amount of assets, liabilities, revenue, costs and expenses, and related disclosures. Homology bases its estimates on historical experience, known trends and events and various other factors that Homology believes are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Homology evaluates its estimates and assumptions on an ongoing basis. Homology’s actual results may differ from these estimates under different assumptions or conditions.

While Homology’s significant accounting policies are described in more detail in the notes to its consolidated financial statements included elsewhere in this proxy statement/prospectus, Homology believes that the following accounting policies are those most critical to the judgments and estimates used in the preparation of its consolidated financial statements.

Revenue Recognition—Homology recognizes revenue in accordance with the Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts

 

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with Customers, or ASC 606. Accordingly, Homology recognizes revenue when it obtains control of promised goods or services, in an amount that reflects the consideration which Homology expects to receive in exchange for those goods or services. To determine the appropriate amount of revenue to be recognized for arrangements determined to be within the scope of ASC 606, Homology performs the following five steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) Homology satisfies each performance obligation. Homology only applies the five-step model to contracts when it is probable that Homology will collect consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, Homology assesses the goods or services promised within each contract and determines those that are performance obligations, and whether each promised good or service is distinct. Homology then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

As part of the accounting for these arrangements, Homology must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. For example, a significant portion of revenue recognized from Homology’s former collaboration with Novartis was related to research and preclinical development work performed whereby revenue was recognized as the underlying services were performed using a cost-to-cost model. Prior to the termination of the collaboration with Novartis, Homology measured the extent of progress towards completion based on the ratio of actual costs incurred to the total estimated costs expected upon satisfying the identified performance obligation.

Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue in Homology’s consolidated balance sheets.

Accrued Research and Development Expenses—As part of the process of preparing its financial statements, Homology is required to estimate its accrued research and development expenses. This process involves reviewing open contracts and purchase orders, communicating with Homology personnel and vendors to identify services that have been performed on Homology’s behalf and estimating the level of service performed and the associated costs incurred for the services when Homology has not yet been invoiced or otherwise notified of the actual costs. The majority of Homology’s service providers invoice Homology in arrears for services performed, on a pre-determined schedule or when contractual milestones are met; however, some require advanced payments. Homology makes estimates of its accrued expenses as of each balance sheet date in its financial statements based on facts and circumstances known to Homology at that time. Examples of estimated accrued research and development expenses include fees paid to contract research organizations and other third parties in connection with performing research activities on Homology’s behalf and conducting preclinical studies and clinical trials on Homology’s behalf and contract manufacturing organizations, including OXB Solutions, in connection with producing product for Homology’s clinical studies, vendors in connection with preclinical development activities and vendors related to product manufacturing and development and distribution of preclinical supplies.

Homology bases accrued expenses related to preclinical and clinical studies on estimates of the services received and efforts expended pursuant to quotes and contracts with CROs that conduct and manage preclinical studies and clinical trials and CMOs, including OXB Solutions, that manufacture product for research and development activities on Homology’s behalf. The financial terms of these agreements are sometimes subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to vendors will exceed the level of services provided and result in a prepayment of the expense. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical milestones. In accruing fees, Homology estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, Homology adjusts the accrual or amount of prepaid expense accordingly.

Although Homology does not expect its estimates to be materially different from expenses actually incurred, if estimates of the status and timing of services performed differ from the actual status and timing of services

 

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performed, Homology may report amounts that are too high or too low in any particular period. To date, Homology has not made any material adjustments to its prior estimates of accrued research and development expenses.

Results of Operations

Comparison of Three Months Ended September 30, 2023 and 2022

The following table summarizes Homology’s results of operations for the three months ended September 30, 2023 and 2022:

 

     Three months ended September 30,         
(in thousands)            2023                      2022              Change  

Collaboration revenue

   $ —        $ 802      $ (802 ) 

Operating expenses:

        

Research and development

     17,519        25,854        (8,335 ) 

General and administrative

     6,842        7,810        (968 ) 

Restructuring and other charges

     6,640        —          6,640  

Total operating expenses

     31,001        33,664        (2,663 ) 

Loss from operations

     (31,001 )       (32,862 )       1,861  

Other income:

        

Interest income

     1,423        1,269        154  

Total other income

     1,423        1,269        154  

Loss before income taxes

     (29,578 )       (31,593 )       2,015  

Benefit from income taxes

     —          46        (46 ) 

Loss from equity method investment

     (3,376 )       (2,179 )       (1,197 ) 

Net loss

   $ (32,954 )     $ (33,726 )     $ 772  

Collaboration Revenue

Collaboration revenue for the three months ended September 30, 2023 was $0.8 million and was due to the recognition of deferred revenue related to the Stock Purchase Agreement with Pfizer. Homology previously recognized deferred revenue from Pfizer over Pfizer’s right of first refusal, or ROFR, period of 30 months during which Pfizer could have negotiated a potential collaboration on the development and commercialization of HMI-102 and HMI-103. The ROFR period expired in May 2023.

Research and Development Expenses

 

     Three months ended September 30,         
(in thousands)            2023                      2022              Change  

External development costs for clinical programs:

        

HMI-102

   $ 3,046      $ 3,866      $ (820 ) 

HMI-103

     7,258        5,459        1,799  

HMI-203

     (366 )       5,984        (6,350 ) 

Other development-stage programs’ external development costs

     5,221        2,498        2,723  

Employee-related costs

     1,193        5,684        (4,491 ) 

Other research and development costs

     1,167        2,363        (1,196 ) 

Total research and development expenses

   $ 17,519      $ 25,854      $ (8,335 ) 

Research and development expenses for the three months ended September 30, 2023 were $17.5 million, compared to $25.9 million for the three months ended September 30, 2022. The decrease of $8.3 million was

 

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primarily associated with Homology’s decision to stop further development of its programs and reduce its workforce by 86% in July 2023 in an effort to decrease its ongoing operating costs. External costs for Homology’s three clinical programs for the three months ended September 30, 2023 reflect the results of reconciliations performed at its CRO and other vendors associated with its clinical trials, as well as the recognition of expense for contractual obligations owed under its Supply Agreement with OXB Solutions. In addition, employee-related costs decreased over the prior quarter primarily due to Homology’s workforce reduction, which it instituted during the three months ended September 30, 2023.

General and Administrative Expenses

General and administrative expenses for the three months ended September 30, 2023 were $6.8 million, compared to $7.8 million for the three months ended September 30, 2022. The decrease of $1.0 million was primarily due to lower consulting, market research costs and facility-related costs.

Restructuring and Other Charges

In connection with the corporate restructuring that reduced Homology’s current workforce by approximately 80 employees, or 86%, Homology recorded a restructuring charge for severance and related costs of $6.9 million during the three months ended September 30, 2023. Homology also modified certain stock options and restricted stock units granted to the terminated employees in a prior period. These equity modifications resulted in a net reduction to stock-based compensation expense of $0.3 million reflected within restructuring and other charges during the three months ended September 30, 2023. See Notes 8 and 10 to Homology’s condensed consolidated financial statements included elsewhere in this proxy statement/prospectus for additional information regarding its corporate restructuring and other charges. Homology did not record restructuring and other charges for the three months ended September 30, 2022.

Interest Income

Interest income for the three months ended September 30, 2023 was $1.4 million, compared to $1.3 million for the three months ended September 30, 2022. The increase of $0.1 million was primarily the result of interest income generated at higher yields on invested funds for the three months ended September 30, 2023, compared to the three months ended September 30, 2022.

Income Tax Benefit

Homology recorded an income tax benefit of less than $0.1 million for the three months ended September 30, 2022. Homology did not record an income tax provision (benefit) for the three months ended September 30, 2023.

Loss from Equity Method Investment

Homology records its share of gains or losses from OXB Solutions on a quarterly basis. For the three months ended September 30, 2023 and 2022, Homology recorded a loss from equity method investment of $3.4 million and $2.2 million, respectively, representing its share of OXB Solutions’ net loss. See Notes 2 and 5 to Homology’s condensed consolidated financial statements included elsewhere in this proxy statement/prospectus for more information regarding the equity method of accounting.

Net Loss

Net loss for the three months ended September 30, 2023 was $33.0 million, compared to $33.7 million for the three months ended September 30, 2022. The decrease in net loss was primarily due to the decrease in operating expenses discussed above.

 

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Comparison of Nine Months Ended September 30, 2023 and 2022

The following table summarizes Homology’s results of operations for the nine months ended September 30, 2023 and 2022:

 

     Nine months ended September 30,         
(in thousands)            2023                      2022              Change  

Collaboration revenue

   $ 1,156      $ 2,406      $ (1,250 ) 

Operating expenses:

        

Research and development

     60,489        71,202        (10,713 ) 

General and administrative

     23,355        29,991        (6.636 ) 

Restructuring and other charges

     6,640        —          6,640  

Total operating expenses

     90,484        101,193        (1,709 ) 

Loss from operations

     (89,328 )       (98,787 )       9,459  

Other income:

        

Gain on sale of business

     —          131,249        (131,249 ) 

Interest income

     4,430        1775        2,628  

Total other income

     4,430        133,024        (128,621 ) 

Income (loss) before income taxes

     (84,925 )       34,237        (119,162 ) 

Provision for income taxes

     —          (816 )       816  

Loss from equity method investment

     (11,917 )       (4,131 )       (7,786 ) 

Net income (loss)

   $ (96,842 )     $ 29,290      $ (126,132 ) 

Collaboration Revenue

Collaboration revenue for the nine months ended September 30, 2023 was $1.2 million, compared to $2.4 million for the nine months ended September 30, 2022, and was due to the recognition of deferred revenue related to the Stock Purchase Agreement with Pfizer in both periods.

Research and Development Expenses

 

     Nine months ended September 30,         
(in thousands)            2023                      2022              Change  

External development costs for clinical programs:

        

HMI-102

   $ 5,822      $ 13,643      $ (7,821 ) 

HMI-103

     16,371        10,767        5,604  

HMI-203

     8,942        11,095        (2,153 ) 

Other development-stage programs’ external development costs

     13,685        6,330        7,355  

Employee-related costs

     11,631        24,025        (12,394 ) 

Other research and development costs

     4,038        5,342        (1,304 ) 

Total research and development expenses

   $ 60,489      $ 71,202      $ (10,713 ) 

Research and development expenses for the nine months ended September 30, 2023 were $60.5 million, compared to $71.2 million for the nine months ended September 30, 2022. The decrease of $10.7 million was primarily due to lower employee-related costs as a result of the reduction in workforce Homology instituted during the three months ended September 30, 2023, in addition to transferring employees to OXB Solutions upon the sale of Homology’s manufacturing business to Oxford in March 2022. In addition, external development costs related to HMI-102, including costs incurred with Homology’s CRO to conduct and manage its pheNIX clinical trial, decreased as the trial was placed on clinical hold in February 2022 and enrollment was paused in August 2022. Partially offsetting these decreases were increased external development costs in the first half of

 

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2023 related to its development-stage programs, including higher spending on HMI-104, its GTx-mAb product candidate for PNH. In addition, external development costs for the HMI-103 clinical program increased over the nine months ended September 30, 2022.

General and Administrative Expenses

General and administrative expenses for the nine months ended September 30, 2023 were $23.4 million, compared to $30.0 million for the nine months ended September 30, 2022. The decrease of $6.6 million was primarily due to a $3.3 million decrease in consulting expenses as the prior year included a fee of $2.5 million paid to a strategic advisory firm that assisted Homology with the OXB Solutions transaction. Employee-related costs decreased by $1.5 million as a result of the reduction in workforce Homology instituted in the three months ended September 30, 2023. In addition, professional fees decreased $0.8 million as Homology incurred higher legal fees in the prior year related to the OXB Solutions Transaction, and depreciation expense and overall facilities costs decreased $0.7 million as compared to the prior year period.

Restructuring and Other Charges

In connection with the corporate restructuring that reduced Homology’s workforce by approximately 80 employees, or 86%, Homology recorded a restructuring charge for severance and related costs of $6.9 million during the nine months ended September 30, 2023. Homology also modified certain stock options and restricted stock units granted to the terminated employees in a prior period. These equity modifications resulted in a net reduction to stock-based compensation expense of $0.3 million reflected within restructuring and other charges during the nine months ended September 30, 2023. See Notes 8 and 10 to Homology’s condensed consolidated financial statements included elsewhere in this proxy statement/prospectus for additional information regarding restructuring and other charges. Homology did not record restructuring and other charges for the nine months ended September 30, 2022.

Gain on Sale of Business

Gain on sale of business for the nine months ended September 30, 2022 was $131.2 million. On March 10, 2022, Homology closed its transaction with Oxford and recorded a gain of $131.2 million on the sale of its manufacturing business. See Note 5 to Homology’s condensed consolidated financial statements included elsewhere in this proxy statement/prospectus for details surrounding the sale.

Interest Income

Interest income for the nine months ended September 30, 2023 was $4.4 million, compared to $1.8 million for the nine months ended September 30, 2022. The increase of $2.6 million was primarily the result of interest income generated at higher yields on invested funds for the nine months ended September 30, 2023 compared to the nine months ended September 30, 2022.

Provision for Income Taxes

Homology recorded an income tax provision of $0.8 million for the nine months ended September 30, 2022. The tax provision predominately resulted from the gain associated with the sale of its manufacturing business due to the transaction with Oxford. Though Homology had substantial pre-tax income for the nine months ended September 30, 2022, Homology had federal and state net operating loss carryforwards and research and development tax credits available to offset most of that taxable income for the period. Homology did not record an income tax provision (benefit) for the nine months ended September 30, 2023.

Loss from Equity Method Investment

Homology records its share of gains or losses from OXB Solutions on a quarterly basis. For the nine months ended September 30, 2023 and 2022, Homology recorded a loss from equity method investment of $11.9 million

 

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and $4.1 million, respectively, representing its share of OXB Solutions’ net loss. The loss from equity method investment for the nine months ended September 30, 2023 includes an other-than-temporary impairment charge of approximately $3.8 million Homology recorded because it was determined that the fair value of its equity method investment in OXB Solutions was less than its carrying value. See Notes 2 and 5 to Homology’s condensed consolidated financial statements included elsewhere in this proxy statement/prospectus for more information regarding the equity method of accounting.

Net Income (Loss)

Net loss for the nine months ended September 30, 2023 was $96.8 million, compared to net income of $29.3 million for the nine months ended September 30, 2022. Net income for the nine months ended September 30, 2022 was primarily due to a gain of $131.2 million on the sale of its manufacturing business, offset by its operating expenses of $101.2 million as described above.

Comparison of Years Ended December 31, 2022 and 2021

The following table summarizes Homology’s results of operations for the years ended December 31, 2022 and 2021:

 

     For the Year Ended December 31,         
(in thousands)            2022                      2021              Change  

Collaboration revenue

   $ 3,208      $ 33,971      $ (30,763 ) 

Operating expenses:

        

Research and development

     98,351        93,085        5,266  

General and administrative

     38,138        36,835        1,303  

Total operating expenses

     136,489        129,920        6,569  

Loss from operations

     (133,281 )       (95,949 )       (37,332 ) 

Other income:

        

Gain on sale of business

     131,249        —          131,249  

Interest income

     3,230        185        3,045  

Total other income

     134,479        185        134,294  

Income (loss) before income taxes

     1,198        (95,764 )       96,962  

Provision for income taxes

     (715 )       —          (715 ) 

Loss from equity method investment

     (5,488 )       —          (5,488 ) 

Net loss

   $ (5,005 )     $ (95,764 )     $ 90,759  

Collaboration Revenue

Collaboration revenue for the year ended December 31, 2022 was $3.2 million, compared to $34.0 million for the year ended December 31, 2021. Collaboration revenue in both periods includes the recognition of collaboration revenue related to the Stock Purchase Agreement with Pfizer. Collaboration revenue for the year ended December 31, 2021 also includes the recognition of deferred revenue and reimbursements incurred under the collaboration and license agreement with Novartis, which terminated in August 2021. As a result of the termination, all remaining deferred revenue pursuant to the collaboration and license agreement with Novartis was recognized as Homology performed the final activities under the collaboration and license agreement through the termination date.

 

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Research and Development Expenses

 

     For the Year Ended December 31,         
(in thousands)            2022                      2021              Change  

External development costs for clinical programs:

   $ 16,245      $ 18,501      $ (2,256 ) 

HMI-102

        

HMI-103

     19,358        10,034        9,324  

HMI-203

     15,839        11,981        3,858  

Other development-stage programs’ external development costs

     9,794        4,035        5,759  

Employee-related costs

     29,654        45,227        (15,573 ) 

Other research and development costs

     7,461        3,307        4,154  

Total research and development expenses

   $ 98,351      $ 93,085      $ 5,266  

Research and development expenses for the year ended December 31, 2022 were $98.4 million, compared to $93.1 million for the year ended December 31, 2021. The increase of $5.3 million was primarily due to increases in direct costs of $9.3 million related to pheEDIT, Homology’s Phase 1 clinical trial with HMI-103 and $3.9 million related to juMPStart, Homology’s Phase 1 clinical trial with HMI-203, as Homology incurred costs to initiate sites and enroll patients in both trials. Additionally, there was a $5.8 million increase in direct research expenses related to its other development-stage programs, primarily due to higher spending on HMI-104, its GTx-mAb product candidate for PNH. Other research and development costs related to laboratory supplies and research materials for its early-stage research programs and platform-development work increased $4.1 million over the prior year. Partially offsetting these increases was a $15.6 million decrease in employee-related costs as a result of transferring employees to OXB Solutions upon the sale of its manufacturing business to Oxford. Homology also experienced a decrease of $2.3 million in direct research expenses for HMI-102 including costs incurred with its CRO to conduct and manage its Phase 2 pheNIX clinical trial as the trial was placed on clinical hold in February 2022 and enrollment was paused in August 2022.

General and Administrative Expenses

General and administrative expenses for the year ended December 31, 2022 were $38.1 million, compared to $36.8 million for the year ended December 31, 2021. The increase of $1.3 million was largely due to the OXB Solutions Transaction, as Homology had an increase in consulting fees of $2.3 million which included a fee of $2.5 million paid to a strategic advisory firm that assisted Homology with the transaction, as well as increased legal and audit fees of $1.8 million, which were primarily related to the OXB Solutions Transaction. In addition, insurance costs increased by $0.2 million. Partially offsetting these increases was a decrease of $1.0 million in depreciation expense as its leasehold improvements were transferred to OXB Solutions upon the sale of its manufacturing business in the first quarter of 2022, as well as a decrease of $0.9 million in market research expense resulting from program prioritization efforts implemented in the second half of 2022. Recruiting costs also decreased by $0.5 million as compared to the prior year.

Gain on Sale of Business

Gain on sale of business for the year ended December 31, 2022 was $131.2 million. On March 10, 2022, Homology closed its transaction with Oxford and recorded a gain of $131.2 million on the sale of its manufacturing business. See Note 6 to Homology’s consolidated financial statements for the years ended December 31, 2021 and 2022 included elsewhere in this proxy statement/prospectus for details surrounding the sale.

 

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Interest Income

Interest income for the year ended December 31, 2022 was $3.2 million, compared to $0.2 million for the year ended December 31, 2021. The increase was the result of significantly higher yields on invested funds for the year ended December 31, 2022 compared to the year ended December 31, 2021.

Provision for Income Taxes

Homology recorded an income tax provision of $0.7 million for the year ended December 31, 2022. The tax provision predominately resulted from the gain associated with the sale of its manufacturing business due to the transaction with Oxford. Though Homology had taxable income for the year ended December 31, 2022, Homology had federal and state net operating loss carryforwards and research and development tax credits available to offset most of that taxable income for the period. Homology did not record an income tax provision (benefit) for the year ended December 31, 2021.

Loss from Equity Method Investment

Homology records its share of gains or losses from OXB Solutions on a quarterly basis. For the year ended December 31, 2022, Homology recorded a loss from equity method investment of $5.5 million representing its share of OXB Solutions’ net loss during the period from March 11, 2022 through December 31, 2022. See Notes 2 and 6 to Homology’s consolidated financial statements for the years ended December 31, 2021 and 2022 included elsewhere in this proxy statement/prospectus for more information regarding the equity method of accounting.

Net Loss

Net loss for the year ended December 31, 2022 was $5.0 million, compared to $95.8 million for the year ended December 31, 2021. The decrease in net loss was primarily due to a gain of $131.2 million on the sale of Homology’s manufacturing business, offset by its operating expenses as described above.

Liquidity and Capital Resources

Since its inception, Homology has incurred significant operating losses. Homology does not have any approved products and has never generated any revenue from product sales. To date, Homology has financed its operations primarily through the sale of common stock, the sale of preferred stock, through an up-front payment and funding of research candidates from a collaboration partner and through the gross proceeds from its transaction with OXB Solutions. Since its inception in 2015, Homology has raised approximately $721 million in aggregate net proceeds through its IPO in April 2018, follow-on public offerings of common stock in April 2019 and April 2021, proceeds from the sale of common stock under an “at-the-market” sales agreement, equity investments from pharmaceutical companies, preferred stock financings and its agreement with Oxford. Included in its net proceeds is a $130.0 million up-front cash payment from its agreement with Oxford, $50.0 million from a former collaboration partner, comprised of an up-front payment of $35.0 million and a $15.0 million equity investment, and a $60.0 million equity investment from Pfizer through a private placement transaction.

ATM Program

On March 9, 2023, Homology filed a Registration Statement on Form S-3 (File No. 333-270414) (the “Shelf”) with the SEC in relation to the registration of up to an aggregate of $250.0 million of its common stock, preferred stock, debt securities, warrants and/or units of any combination thereof for a period up to three years from the date of the filing. The Shelf became effective on March 17, 2023. Homology also simultaneously entered into a sales agreement with TD Cowen, as sales agent, providing for the offering, issuance and sale by Homology of up to an aggregate of $75.0 million of its common stock from time to time in “at-the-market”

 

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offerings under the Shelf (the “ATM”). Homology did not sell any shares of common stock under the ATM during the nine months ended September 30, 2023. As of September 30, 2023, there remained $75.0 million of common stock available for sale under the ATM.

Oxford Biomedica Solutions Transaction

On March 10, 2022, Homology closed a transaction with Oxford pursuant to the Purchase Agreement, dated as of January 28, 2022, by and among Homology, OXB Solutions and Oxford, whereby, among other things, Homology and Oxford agreed to collaborate to operate OXB Solutions, which provides AAV vector process development services and manufacturing services to pharmaceutical and biotechnology companies. Pursuant to the terms of the agreements entered into as part of the OXB Solutions Transaction, Homology assigned and transferred to OXB Solutions all of its assets that are primarily used in the manufacturing of AAV vectors for use in gene therapy and gene editing products. Oxford paid Homology $130.0 million upfront and invested $50.0 million to fund the new company in exchange for an 80 percent ownership stake, while Homology owns 20 percent of the new company. Also, at any time following the three-year anniversary of the closing of the transaction, Oxford has an option to cause Homology to sell and transfer to Oxford and Homology has an option to cause Oxford to purchase from Homology, in each case all of its equity ownership interest in OXB Solutions at a price equal to 5.5 times the revenue for the immediately preceding 12-month period, subject to a maximum amount of $74.1 million. See Note 5 to Homology’s condensed consolidated financial statements included elsewhere in this proxy statement/prospectus for additional information regarding the Oxford transaction.

Strategic Collaborations and Investments

On November 9, 2020, Homology entered into the Stock Purchase Agreement with Pfizer, pursuant to which Pfizer purchased 5,000,000 shares of Homology’s common stock through a private placement transaction at a purchase price of $12.00 per share, for an aggregate purchase price of $60.0 million. Under the Stock Purchase Agreement, Pfizer was granted an exclusive right of first refusal, or ROFR, for a 30-month period to negotiate a potential collaboration on the development and commercialization of HMI-102 and HMI-103. The 30-month ROFR period expired on May 9, 2023. In addition to the ROFR, the Stock Purchase Agreement provided for an information sharing committee comprised of representatives of each company which served as a forum for sharing information regarding the development of HMI-102 and HMI-103 during the ROFR period. Additionally, Pfizer designated a member to join Homology’s Scientific Advisory Board to participate in matters related to the development of these programs.

Strategic Review and Reduction in Force

On July 25, 2023, Homology’s board of directors approved a process to explore, review and evaluate a range of potential strategic options available to Homology, including, without limitation, an acquisition, merger, reverse merger, sale of assets, strategic partnerships or other transactions. Therefore, based on cost-reduction initiatives intended to reduce Homology’s ongoing operating expenses and maximize shareholder value as Homology evaluated strategic options, its board of directors also approved a reduction in Homology’s current workforce by approximately 80 employees. In connection with this corporate restructuring, Homology recorded a restructuring charge for severance and related costs of $6.9 million in its condensed consolidated statements of operations during the three months ended September 30, 2023.

Cash Flows

Homology’s cash, cash equivalents, and short-term investments totaled $103.3 million and $175.0 million as of September 30, 2023 and December 31, 2022, respectively. Homology had no indebtedness as of September 30, 2023 and December 31, 2022.

 

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The following table summarizes Homology’s sources and uses of cash for each of the periods presented:

 

     Nine months ended September 30,  
(in thousands)            2023                      2022          

Net cash used in operating activities

   $ (74,655 )     $ (86,462 ) 

Net cash provided by investing activities

     69,610        18,725  

Net cash provided by financing activities

     170        564  

Net change in cash, cash equivalents and restricted cash

   $ (4,875 )     $ (67,173 ) 

Operating Activities

Net cash used in operating activities for the nine months ended September 30, 2023 was $74.7 million, which was primarily utilized for the funding of Homology’s operating expenses of $90.5 million, as Homology incurred expenses associated with research and development activities including clinical trial activities associated with its HMI-103 and HMI-203 programs, preclinical development activities including IND-enabling studies for HMI-104 and research activities on other applications for its technology, adjusted for non-cash expenses of $17.9 million. Non-cash expenses includes an $11.9 million loss from its equity method investment in OXB Solutions, $6.5 million of stock-based compensation expense and noncash lease expense of $1.1 million, partially offset by accretion on short-term investments of $2.3 million. The change in operating assets and liabilities of $4.3 million was driven by increased accounts payable of $6.7 million and decreased prepaid expenses and other current assets of $3.0 million, partially offset by decreased accrued expenses and other liabilities of $3.0 million and decreased deferred revenue of $1.2 million.

Net cash used in operating activities for the nine months ended September 30, 2022 was $86.5 million, primarily due to its net income of $2.3 million offset by the $131.2 million gain recognized on the sale of its manufacturing business to Oxford. Further offsetting its net income was an increase in prepaid expenses and other current assets of $5.3 million primarily due to the receivable from OXB Solutions, as well as a decrease in deferred revenue of $2.4 million. Conversely, Homology had net non-cash expenses of $15.2 million, which included $10.0 million of stock-based compensation expense and a $4.1 million loss from its equity method investment in OXB Solutions, $5.7 million of increased accrued expenses and other liabilities and $2.7 million of increased accounts payable, all of which reduced its net cash used in operating activities for the nine months ended September 30, 2022.

Investing Activities

Net cash provided by investing activities for the nine months ended September 30, 2023 was $69.6 million, primarily due to proceeds from maturities of short-term investments of $142.7 million, offset by purchases of short-term investments of $73.2 million.

Net cash provided by investing activities for the nine months ended September 30, 2022 was $18.7 million, primarily due to $130.0 million of cash received from Oxford pursuant to the OXB Solutions Transaction (see Note 5 to Homology’s condensed consolidated financial statements included elsewhere in this proxy statement/prospectus). Homology also had proceeds from maturities of short-term investments of $157.5 million, offset by purchases of short-term investments of $49.2 million and purchases of property and equipment of $1.3 million.

Financing Activities

Net cash provided by financing activities for the nine months ended September 30, 2023 was $0.2 million, due to proceeds from the issuance of common stock pursuant to Homology’s employee stock purchase plan.

Net cash provided by financing activities for the nine months ended September 30, 2022 was $0.6 million, due to proceeds from the issuance of common stock pursuant to Homology’s employee stock purchase plan.

 

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Homology’s cash, cash equivalents and short-term investments totaled $175.0 million and $155.9 million as of December 31, 2022 and 2021, respectively. Homology had no indebtedness as of December 31, 2022 and 2021.

The following table summarizes Homology’s sources and uses of cash for each of the periods presented:

 

     For the Year Ended December 31,  
(in thousands)            2022                      2021          

Net cash used in operating activities

   $ (113,661 )     $ (109,751 ) 

Net cash provided by (used in) investing activities

     36,716        (50,788 ) 

Net cash provided by financing activities

     596        52,169  

Net change in cash, cash equivalents and restricted cash

   $ (76,349 )     $ (108,370 ) 

Though Homology’s net change in cash, cash equivalents and restricted cash for the year ended December 31, 2022 was a decrease of $76.3 million, Homology had a net increase of $93.5 million in short-term investments primarily due to the $130.0 million up-front payment Homology received from Oxford in connection with the OXB Solutions Transaction.

Operating Activities

Net cash used in operating activities for the year ended December 31, 2022 was $113.7 million, which was primarily utilized for the funding of Homology’s operating expenses of $136.5 million, as Homology incurred expenses associated with research and development activities including clinical trial activities associated with its HMI-103, HMI-203 and HMI-102 programs, preclinical development activities including IND-enabling studies for HMI-104 and research activities on other applications for its technology, adjusted for non-cash expenses of $112.0 million, which includes the one-time gain of $131.2 million recognized on the sale of its manufacturing business to Oxford, and a change in operating assets and liabilities of $3.4 million. The change in operating assets and liabilities was driven by increased accrued expenses and other liabilities of $7.4 million largely due to materials produced for Homology by OXB Solutions and accrued for at year-end, offset by decreased deferred revenue of $3.2 million and decreased accounts payable of $1.0 million.

Net cash used in operating activities for the year ended December 31, 2021 was $109.8 million, driven primarily by its net loss of $95.8 million as Homology incurred expenses associated with research and development activities on HMI-102, HMI-103 and HMI-203, including the Phase 2 pheNIX trial for its HMI-102 program, and research activities on other applications for its technology, a decrease in deferred revenue of $33.4 million, and a decrease in operating lease liabilities of $2.4 million. These items were partially offset by net non-cash expenses of $27.8 million, which includes $17.2 million of stock-based compensation expense and $8.4 million of depreciation expense.

Investing Activities

Net cash provided by investing activities for the year ended December 31, 2022 was $36.7 million, primarily due to $130.0 million of cash received from Oxford pursuant to the OXB Solutions Transaction (see Note 6 to Homology’s consolidated financial statements for the years ended December 31, 2021 and 2022 included elsewhere in this proxy statement/prospectus). Homology also had proceeds from maturities of short-term investments of $65.5 million. These two items were offset by purchases of short-term investments of $157.5 million and purchases of property and equipment of $1.3 million.

Net cash used in investing activities for the year ended December 31, 2021 was $50.8 million, attributable to maturities of short-term investments of $49.0 million, offset by purchases of short-term investments of $97.4 million and purchases of property and equipment of $2.4 million.

 

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Financing Activities

Net cash provided by financing activities for the year ended December 31, 2022 was $0.6 million, due to proceeds from the issuance of common stock pursuant to Homology’s employee stock purchase plan.

Net cash provided by financing activities for the year ended December 31, 2021 was $52.2 million, primarily due to $49.7 million of net proceeds from the issuance of common stock in follow-on public offerings and $1.5 million of net proceeds from the issuance of common stock pursuant to ATM financing.

Funding Requirements

Operating expenses decreased during the nine months ended September 30, 2023 as compared to the nine months ended September 30, 2022. Homology currently expects its expenses to continue to decrease in 2023 compared to 2022 due to its decision to stop all further development of its product candidates and the recent implementation of an 86% workforce reduction. Homology will continue to incur costs associated with operating as a public company. If Homology decides to resume the development of its product candidates, however, Homology expect its expenses to increase in order to advance preclinical activities and clinical trials for product candidates in development. After a comprehensive review of strategic alternatives, on November 16, 2023, Homology entered into the Merger Agreement. Following the Merger, if successfully consummated, Homology does not anticipate any further development of its product candidates or programs.

As of September 30, 2023, Homology had cash, cash equivalents, and short-term investments of $103.3 million. Based on Homology’s current projections, Homology believes that its existing cash, cash equivalents, and short-term investments as of September 30, 2023 will enable Homology to continue its operations for at least one year from the date of its Quarterly Report on Form 10-Q for the period ended September 30, 2023. However, in light of the discontinuation of all of Homology’s clinical trials and research activities, as well as its recent reduction in force of all but a few custodial employees, Homology has concluded that there is a substantial doubt regarding its ability to continue as a going concern for more than twelve months after the date the unaudited condensed consolidated financial statements included elsewhere in this proxy statement/prospectus have been issued.

Homology has based these estimates on assumptions that may prove to be imprecise, and Homology may use its available capital resources sooner than it currently expects. In addition, its resource requirements could materially change if it is unable to consummate the Merger. As a result, Homology is unable to estimate the exact amount of its working capital requirements. Should Homology resume development of product candidates in the future, its future funding requirements would depend on and could increase significantly as a result of many factors, including:

 

  •  

the costs, timing, and results of research and development efforts, including clinical trials;

 

  •  

the costs and timing of process development scale-up activities, and the adequacy of supply of product candidates for preclinical studies and clinical trials through CMOs, including OXB Solutions;

 

  •  

the costs and timing of preparing, filing, and prosecuting patent applications, maintaining and enforcing its intellectual property rights and defending any intellectual property-related claims, including any claims by third parties that Homology is infringing upon their intellectual property rights;

 

  •  

the effect of competitors and market developments; and

 

  •  

its ability to establish and maintain strategic collaborations, licensing or other agreements and the financial terms of such agreements for its product candidates.

Homology maintains the majority of its cash and cash equivalents in accounts with major highly rated multi-national and local financial institutions, and its deposits at these institutions exceed insured limits. Market

 

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conditions can impact the viability of these institutions, and any inability to access or delay in accessing these funds could adversely affect its business and financial position. In the event of failure of any of the financial institutions where Homology maintains its cash and cash equivalents, there can be no assurance that Homology will be able to access uninsured funds in a timely manner or at all.

Further, the global economy, including credit and financial markets, has recently experienced extreme volatility and disruptions, including severely diminished liquidity and credit availability, rising interest and inflation rates, declines in consumer confidence, declines in economic growth, increases in unemployment rates, uncertainty about economic stability, and COVID-19. All of these factors could impact its liquidity and future funding requirements, including but not limited to its ability to raise additional capital when needed on acceptable terms, if at all. The duration of this economic slowdown is uncertain and the impact on its business is difficult to predict. See “Risk Factors—Unstable global political or economic conditions may have serious adverse consequences on Homology’s business, financial condition and share price” included elsewhere in this proxy statement/prospectus.

Until such time, if ever, that Homology can generate product revenue, and subject to its pursuit of a potential strategic transaction and the consummation of such potential transaction, Homology expects to finance its cash needs through a combination of equity offerings, debt financings, collaboration agreements, other third-party funding, strategic alliances, licensing arrangements and marketing and distribution arrangements. To the extent that Homology raises additional capital through the sale of equity or convertible debt securities, the ownership interests of its stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of its stockholders as common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting its ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If Homology raises additional funds through other third-party funding, collaboration agreements, strategic alliances, licensing arrangements or marketing and distribution arrangements, Homology may have to relinquish valuable rights to its technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to Homology. If Homology resumes the development of product candidates and is unable to raise additional funds through equity or debt financings when needed, Homology may be required to delay, limit, reduce or terminate its product development or future commercialization efforts, or grant rights to develop and market products or product candidates that Homology would otherwise prefer to develop and market itself.

Contractual Obligations

As of September 30, 2023, Homology had non-cancelable operating leases with total future minimum lease payments of $41.5 million, of which $1.1 million will be payable in 2023. These minimum lease payments exclude Homology’s share of the facility operating expenses, real-estate taxes and other costs that are reimbursable to the landlord under the leases. These payments are for operating leases for Homology’s corporate headquarters in Bedford, Massachusetts, comprised of office, manufacturing and lab space that expire in June 2030 and May 2032. Under the terms of the OXB Solutions Transaction, Homology’s leases for this space has been assigned to OXB Solutions effective March 10, 2022, with Homology subleasing a portion of lab and office space back from OXB Solutions. This assignment significantly decreases Homology’s contractual obligations under Homology’s operating leases to approximately $9.0 million through 2024 when the sublease expires.

On September 25, 2023, Homology signed and executed a release letter with its lessor related to its headquarters in Bedford, MA. The lessor agreed to release Homology of all obligations under the lease effective October 1, 2023 in exchange for a $0.1 million cash payment. On October 1, 2023, Homology wrote off the right-of-use asset and operating lease liability and record the difference as a gain within other income on the condensed consolidated statements of operations. See Note 14 to Homology’s unaudited condensed consolidated financial statements included elsewhere in this proxy statement/prospectus for additional information regarding its lease agreement.

 

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Homology’s agreements with certain institutions to license intellectual property include potential milestone and success fees, sublicense fees, royalty fees, licensing maintenance fees, and reimbursement of patent maintenance costs that Homology may be required to pay. Homology’s agreements to license intellectual property include potential milestone payments that are dependent upon the development of products using the intellectual property licensed under the agreements and contingent upon the achievement of development or regulatory approval milestones, as well as commercial milestones. These potential obligations are contingent upon the occurrence of future events and the timing and likelihood of such potential obligations are not known with certainty. For further information regarding these agreements, please see “Strategic Collaborations.”

Homology enters into contracts in the normal course of business with CROs and CMOs for clinical trials, preclinical research studies and testing, manufacturing and other services and products for operating purposes. These contracts generally do not contain any minimum purchase commitments and are cancelable by Homology upon prior notice of 30 days and, as a result, are not included in the table of contractual obligations above. Pursuant to the terms of the Supply Agreement with OXB Solutions entered into in March 2022, Homology agreed to purchase from OXB Solutions at least 50% of its clinical supply requirements of AAV-based products during the initial term of the Supply Agreement. Homology was committed to purchase a minimum number of batches of drug substance and drug product, as well as process development services, totaling approximately $29.7 million in 2023 under the Supply Agreement. Homology does not have any commitments to purchase products or services from OXB in 2024. The Supply Agreement provides for an initial term of three years, which period may be extended for an additional one-year term. After the initial term, Homology will have the right to terminate the Supply Agreement for convenience or other reasons specified in the Supply Agreement upon prior written notice. Either Party may terminate the Supply Agreement upon an uncured material breach by the other Party or upon the bankruptcy or insolvency of the other Party.

Quantitative and Qualitative Disclosures About Market Risk.

Homology is exposed to market risks in the ordinary course of its business. These risks primarily include interest rate sensitivities.

Interest Rate Risk

Homology’s interest-earning assets consist of cash and cash equivalents and short-term investments of $103.3 million, or 73.8% of its total assets as of September 30, 2023, and $175.0 million, or 76.6% of its total assets as of December 31, 2022. Interest income earned on these assets was approximately $4.4 million and $1.8 million for the nine months ended September 30, 2023 and 2022, respectively. Homology’s interest income is sensitive to changes in the general level of interest rates, primarily U.S. interest rates. If a 10% change in interest rates were to have immediately occurred on September 30, 2023, this change would not have had a material effect on the fair value of its investment portfolio as of that date. As of September 30, 2023, Homology’s cash equivalents consisted of bank deposits and money market funds. Such interest-earning instruments carry a degree of interest rate risk; however, historical fluctuations in interest income have not been significant for Homology. Homology had no debt outstanding as of September 30, 2023 and December 31, 2022.

Inflation Rate Risk

As of September 30, 2023, Homology does not believe that inflation has had a material effect on its business, financial condition or results of operations. To the extent inflation results in rising interest rates and has other adverse effects on the market, it may adversely affect Homology’s business, financial condition and results of operations.

 

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Q32 MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of Q32’s financial condition and results of operations should be read together with Q32’s consolidated financial statements and the related notes appearing elsewhere in this proxy statement/prospectus. This discussion and other parts of this proxy statement/prospectus contain forward-looking statements that involve risks and uncertainties, such as statements regarding Q32’s plans, objectives, expectations, intentions and projections. Q32’s actual results could differ materially from those described in or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the “Risk Factors” section of this proxy statement/prospectus.

Overview

Q32 Bio Inc., or Q32, is a clinical stage biotechnology company focused on developing novel biologics to effectively and safely restore healthy immune balance in patients with autoimmune and inflammatory diseases driven by pathological immune dysfunction. To achieve this goal of restoring homeostasis to a dysregulated immune system, Q32 is advancing antibody-based therapeutic candidates designed to target two central pathways of adaptive and innate immunity. The adaptive immune system is largely composed of T- and B-cell mediated cellular and antibody responses: while the innate immune system is a first line of defense employing leukocytes such as monocytes, macrophages, neutrophils, dendritic cells and natural killer cells that are responsible for clearing pathogens and cellular debris, and modulating T- and B-cell function. Q32 believes that targeting these key pathways of immune dysregulation in autoimmune and inflammatory diseases will deliver therapeutics for indications with clear unmet medical need in the near term, while enabling Q32 to build a broad and diverse pipeline in the long term. Q32 has multiple product candidates across a variety of these diseases with clinical readouts for Q32’s two lead programs expected in 2024 and 2025.

Bempikibart (ADX-914), Q32’s most advanced product candidate, is a fully human anti-interleukin-7 receptor alpha, or IL-7Rα, antagonist monoclonal antibody designed to re-regulate adaptive immune function by blocking signaling mediated by interleukin-7, or IL-7, and thymic stromal lymphopoietin, or TSLP. Bempikibart is being studied in two double-blind, placebo-controlled Phase 2 clinical trials designed to establish proof of clinical concept and evaluate Q32’s selected Phase 2 dose. One trial is evaluating the use of bempikibart for the treatment of atopic dermatitis, or AD, and one is evaluating bempikibart for the treatment of alopecia areata, or AA. Enrollment in both clinical trials remains ongoing and Q32 remains on track to report topline data from both Phase 2 clinical trials in the second half of 2024.

ADX-097, the lead product candidate from Q32’s complement inhibitor platform, is a humanized anti-C3d monoclonal antibody, or mAb, fusion protein. ADX-097 is designed to restore complement regulation—an integral part of the innate immune system—through a tissue targeted mechanism. ADX-097 is designed to inhibit alternative pathway complement activation locally in diseased tissues where complement-mediated pathology is actively manifest. Q32 believes ADX-097 has the potential to drive improved clinical activity and address the limitations of the currently available systemic approaches to complement inhibition, including infection risk and the need for high drug doses and frequent administration, to achieve therapeutic levels of inhibition. Q32 is developing ADX-097 for the treatment of renal and other complement-mediated diseases of high unmet need, including lupus nephritis, or LN, immunoglobulin A, or IgA, nephropathy, or IgAN, complement component 3 glomerulopathy, or C3G, and anti-neutrophil cytoplasmic antibody, or ANCA-associated vasculitis, or AAV. Q32 has completed dosing of healthy volunteers in a Phase 1 trial of ADX-097. Q32 expects to initiate an open-label Phase 2 renal basket program in the first half of 2024, with initial data expected by year-end 2024, and initiate a Phase 2 clinical trial in AAV, with topline data from both the renal basket and AAV trials anticipated in the second half of 2025.

In addition to bempikibart and ADX-097, Q32 is also engaged in additional pipeline efforts to expand therapeutic opportunities within complement mediated diseases.

 

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Recent Developments

Rights to Bempikibart

From August 2022 until November 2023, Q32 was a party to the Collaboration and Option Agreement, or the Horizon Collaboration Agreement, and the Asset Purchase Agreement, or the Purchase Agreement, and together with the Horizon Collaboration Agreement, the Horizon Agreements, each between Q32 and Horizon Therapeutics Ireland DAC, or Horizon, pursuant to which Q32 received $55.0 million in initial consideration and staged development funding for the completion of the two ongoing Phase 2 trials for bempikibart, and Horizon had an option to acquire the bempikibart program at a prespecified price, subject to certain adjustments.

In October 2023, Amgen, Inc., or Amgen, completed the acquisition of Horizon Therapeutics public limited company, or Horizon plc. Following its acquisition of Horizon plc, Q32 agreed with Amgen to mutually terminate the Horizon Agreements and on November 2023, Q32 and Horizon entered into a termination agreement, or the Horizon Termination Agreement, pursuant to which Horizon’s option to acquire the bempikibart program was terminated. As a result, Q32 retained the initial consideration and all development funding received under the Horizon Collaboration Agreement and regained full development and commercial rights to bempikibart. In consideration for the Horizon Termination Agreement, Q32 agreed to pay Horizon regulatory and sales milestones payments of up to an aggregate amount of $75.1 million upon the first achievement of certain regulatory and sales milestones with respect to bempikibart.

Proposed Merger and Pre-Closing Financing

On November 16, 2023, Q32 entered into an Agreement and Plan of Merger and Reorganization, or the Merger Agreement, with Homology Medicines, Inc, or Homology, and Kenobi Merger Sub, Inc., a wholly owned subsidiary of Homology, or Merger Sub. Pursuant to the Merger Agreement and subject to the satisfaction or waiver of the conditions therein, Merger Sub will merge with and into Q32, with Q32 continuing as the surviving company and as a wholly owned subsidiary of Homology, or the Merger. If the Merger is completed, the business of Q32 will continue as the business of the combined company. The Merger is intended to qualify for federal income tax purposes as a tax-free reorganization under the provisions of Section 368(a) of the Internal Revenue Code of 1986, as amended. After completion of the Merger, Homology will be renamed “Q32 Bio Inc.” and the business of Q32 will continue as the business of the combined company.

The Merger is expected to close in the first quarter of 2024 and is subject to approval by the stockholders of Q32 and Homology as well as other customary closing conditions, including the effectiveness of a registration statement filed with the SEC in connection with the transaction. If Homology is unable to satisfy certain closing conditions or if other mutual closing conditions are not satisfied, Q32 will not be obligated to complete the Merger.

Subject to the terms and conditions of the Merger Agreement, at the effective time of the Merger, or the Effective Time, each then outstanding share of Q32’s common stock (including shares of common stock issued upon conversion of Q32’s preferred stock, shares of Q32’s common stock issued upon conversion of Q32’s convertible notes and shares of Q32’s common stock issued in the Q32 Pre-Closing Financing defined below) will be converted into the right to receive a number of shares of Homology’s common stock calculated in accordance with the Merger Agreement, or the exchange ratio.

In connection with the Merger Agreement, certain third parties have entered into a subscription agreement with Q32 to purchase shares of Q32’s common stock for an aggregate purchase price of approximately $42.0 million, or the Q32 Pre-Closing Financing. The Q32 Pre-Closing Financing is contingent on and will occur prior to the closing of the Merger, subject to customary closing conditions. Shares of Q32’s common stock issued pursuant to the Q32 Pre-Closing Financing will be converted into shares of Homology common stock in accordance with the exchange ratio at the Effective Time.

Each share of Homology common stock that is issued and outstanding at the Effective Time will remain issued and outstanding and such shares, subject to the Reverse Stock Split, will be unaffected by the Merger.

 

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At the Effective Time, each person who as of immediately prior to the Effective Time was a stockholder of record of Homology or had the right to receive Homology’s common stock will be entitled to receive a contractual contingent value right, or CVR, issued by Homology subject to and in accordance with the terms and conditions of a Contingent Value Rights Agreement between Homology and the rights agent, or the CVR Agreement, representing the contractual right to receive cash payments from the combined company upon the receipt of certain proceeds from a disposition of Homology’s pre-merger assets, calculated in accordance with the CVR Agreement.

The Merger is expected to be treated as a reverse recapitalization in accordance with accounting principles generally accepted in the United States, or GAAP, because on the effective date of the Merger, the pre-combination assets of Homology are expected to be primarily cash and cash equivalents, short-term investments, and other non-operating assets. Q32 concluded that any in-process research and development assets potentially remaining as of the combination would be de minimis when compared to the cash, cash equivalents, short-term investments obtained through the Merger.

Financial Operations Overview

Revenue

Since its inception, Q32 has not generated any revenue from product sales, and management does not expect Q32 to generate any revenue from the sale of products in the foreseeable future.

Q32 entered into the Horizon Agreements on August 12, 2022. Per the terms of the Horizon Collaboration Agreement, Q32 received a total of $55.0 million upon initiation of certain development activities associated with the planned clinical trials and related activities. Prior to its termination, the Purchase Agreement also provided Horizon the option to purchase bempikibart, which would have triggered a prespecified payment to Q32, if exercised. Q32 was also entitled to receive from Horizon additional payments based on the achievement of future development and regulatory milestones as well as royalty payments on annual net sales.

Q32 concluded that the arrangement is partially within the scope of Topic 606. Specifically, Q32 concluded that the research services required to be performed as part of the Horizon Collaboration Agreement represent an output of Q32’s ordinary activities, and this represents a contract with a customer. Q32 concluded that the potential sale of bempikibart is not an output of Q32’s ordinary activities and therefore this component of the Horizon Agreements is considered to be a sale of an asset and not accounted for under Topic 606.

There are two performance obligations related to the development activities of bempikibart, one of each of the specified clinical trials in AD and AA, with each composing the services related to the clinical trial and other related development activity. Q32 also identified a material right related to the option for Horizon to purchase bempikibart. The material right was considered a separate performance obligation pursuant to the provisions of Topic 606. Q32 determined the transaction price to be $55.0 million which it allocated to the three performance obligations based on the estimated stand-alone selling price of each performance obligation. Q32 concluded that the consideration allocated to the research service performance obligations should be recognized over time as Horizon receives the benefit of the research activities as the activities are performed. Q32 determined that the most appropriate method to track progress towards completion of these two performance obligations is an input method that is based on costs incurred. Any changes to these estimates will be recognized in the period in which they change as a cumulative catch-up. The consideration allocated to the material right will be included in the arrangement consideration upon exercise of the option or recognized upon expiration of the option.

Revenue recognition will vary period over period based on the ongoing research performed on behalf of Horizon. Q32 recognized $8.0 million of collaboration arrangement revenue for the nine months ended September 30, 2023. As of September 30, 2023, approximately $40.3 million remained in deferred collaboration revenue, of which $24.8 million was included in deferred revenue, current portion and $15.5 million was included in deferred revenue, net of current portion on the consolidated balance sheets, based on anticipating timing of recognition of the amounts.

 

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On November 10, 2023, Q32 entered into a termination agreement with Horizon terminating the Horizon Agreements, as described under “—Recent Developments” above.

Operating Expenses

Research and Development

Research and development expenses account for a significant portion of Q32’s operating expenses and consist primarily of external and internal expenses incurred in connection with the discovery and development of its product candidates. External expenses include:

 

  •  

expenses incurred in connection with Q32’s research and development activities, including costs related to agreements with third parties such as consultants, contractors and clinical research organizations, or CROs;

 

  •  

costs related to contract development and manufacturing organizations, or CDMOs, that are primarily engaged to provide drug substance and product for Q32’s preclinical studies, clinical trials and research and development programs, as well as investigative sites and consultants that conduct Q32’s clinical trials, preclinical studies and other scientific development services;

 

  •  

costs related to compliance with quality and regulatory requirements;

 

  •  

employee-related expenses, including salaries, benefits, and stock-based compensation expense, for personnel engaged in research and development functions; and

 

  •  

facilities-related expenses, depreciation, supplies, travel expenses and other allocated expenses.

Q32 expenses research and development costs as incurred. Costs are recognized based on an evaluation of the progress to completion of specific tasks using information provided to Q32 by its service providers or its estimate of the level of service that has been performed at each reporting date. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and may be reflected in Q32’s consolidated financial statements as prepaid or accrued expenses. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses and expensed as the related goods are delivered or the services are performed or when it is no longer expected that the goods will be delivered or the services rendered.

Q32 does not allocate direct external research and development costs to specific programs or product candidates until there is an internally designated development candidate. Q32 typically uses its employee and infrastructure resources across its product candidates and development programs. Q32 does not allocate personnel costs or other internal costs to research and development programs and product candidates.

Q32 expects that future changes to its research and development expenses will depend significantly on the success of its clinical data. Q32 expects that research and development expenses will increase substantially as Q32 continues to advance its programs into and through clinical development. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. At this time, Q32 cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any product candidates. A change in the outcome of any number of variables with respect to product candidates Q32 may develop could significantly change the costs and timing associated with the development of that product candidate. Q32 may never succeed in obtaining regulatory approval for any product candidates it may develop. The successful development of any product candidate is highly uncertain. This is due to the numerous risks and uncertainties associated with product development, including the following:

 

  •  

the timing and progress of preclinical and clinical development activities;

 

  •  

the number and scope of preclinical and clinical programs Q32 decides to pursue;

 

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  •  

the ability to raise additional funds necessary to complete clinical development of and commercialize of Q32’s product candidates;

 

  •  

the successful initiation, enrollment and completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority;

 

  •  

the receipt and related terms of regulatory approvals from applicable regulatory authorities for any product candidates;

 

  •  

the availability of raw materials for use in production of Q32’s product candidates;

 

  •  

establishing agreements with third-party manufacturers for supply of product candidate components for Q32’s clinical trials;

 

  •  

Q32’s ability to maintain its current research and development programs and to establish new programs;

 

  •  

significant and changing government regulations;

 

  •  

Q32’s ability to obtain and maintain patents, trade secret protection and regulatory exclusivity, both in the United States and internationally;

 

  •  

Q32’s ability to protect its other rights in its intellectual property portfolio;

 

  •  

commercializing product candidates, if and when approved, whether alone or in collaboration with others; and

 

  •  

obtaining and maintaining third-party insurance coverage and adequate reimbursement for any approved products.

General and Administrative Expenses

General and administrative expenses primarily consist of salaries, bonuses, related benefits, and stock-based compensation expense for personnel in executive, finance, and administrative functions; professional fees for corporate legal and patent matters, consulting, accounting, and audit services; and travel expenses, insurance, technology costs and other allocated expenses. General and administrative expenses also include corporate facility costs, including rent, utilities, depreciation, and maintenance, not otherwise included in research and development expense. Q32 recognizes general and administrative expenses in the periods in which they are incurred. General and administrative expenses are expected to increase as a public company.

Change in Fair Value of Convertible Notes

During 2022, Q32 recognized a liability as a result of the issuance of convertible promissory notes, or the Convertible Notes. Q32 accounts for all Convertible Notes issued under the fair value option election of ASC 825, Financial Instruments (ASC 825). The financial instrument is initially measured at its issue-date estimated fair value and then subsequently remeasured at estimated fair value on a recurring basis at each reporting period date. The estimated fair value adjustment is recognized within other income (expense) in the accompanying consolidated statements of operations and the portion of the fair value adjustment attributed to a change in the instrument-specific credit risk is recognized as a component of other comprehensive loss, if any.

The change in fair value of the Convertible Notes is expected to vary period over period, based on changes in the estimated fair value of the equity into which the Convertible Notes will be issued, the pending Merger with Homology, or other future financing, and other factors.

Other income (expense), net

Other income (expense), net consists of interest income primarily earned on money market fund accounts and other short-term investments and interest expense related to Q32’s debt obligations.

 

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Results of Operations

Comparison of the Nine Months Ended September 30, 2023 and 2022

The following table summarizes Q32’s results of operations for the nine months ended September 30, 2023 and 2022:

 

     Nine Months Ended
September 30,
        
     2023      2022      Change  
     (in thousands)         

Collaboration arrangement revenue

   $ 8,011      $ 2,871      $ 5,140  

Operating expenses:

        

Research and development

     23,390        26,624        (3,234 ) 

General and administrative

     7,067        7,561        (494 ) 
  

 

 

    

 

 

    

 

 

 

Total operating expense

     30,457        34,185        (3,728 ) 
  

 

 

    

 

 

    

 

 

 

Loss from operations

     (22,446 )       (31,314 )       8,868  

Change in fair value of convertible notes

     (4,992 )       (997 )       (3,995 ) 

Other income (expense), net

     827        (765 )       1,592  
  

 

 

    

 

 

    

 

 

 

Loss before provision for income taxes

     (26,611 )       (33,076 )       6,465  

Provision for income taxes

     (65 )       (45 )       (20 ) 

Net loss

   $ (26,676 )     $ (33,121 )     $ 6,445  
  

 

 

    

 

 

    

 

 

 

Collaboration Arrangement Revenue

Q32 recognized $8.0 million of collaboration arrangement revenue for the nine months ended September 30, 2023 compared to $2.9 million for the nine months ended September 30, 2022. Q32 executed the Horizon Collaboration Agreement in August 2022 and began performing research services; therefore, there was increased revenue during fiscal 2023 due to the length of time services were performed.

Research and Development Expenses

The following table summarizes Q32’s research and development expenses for the nine months ended September 30, 2023 and 2022:

 

     Nine Months Ended
September 30,
        
     2023      2022      Change  
     (in thousands)         

Direct research and development expense by program:

        

ADX-097

   $ 5,784      $ 7,070      $ (1,286 ) 

Bempikibart

     8,139        8,773        (634 ) 

Discovery and other

     589        909        (320 ) 

Unallocated expenses:

        

Personnel-related and consulting (including stock-based compensation)

     7,149        7,950        (801 ) 

Indirect research and development expense

     1,729        1,922        (193 ) 
  

 

 

    

 

 

    

 

 

 

Total research and development expenses

   $ 23,390      $ 26,624      $ (3,234 ) 
  

 

 

    

 

 

    

 

 

 

Research and development expenses were $23.4 million for the nine months ended September 30, 2023, compared to $26.6 million for the nine months ended September 30, 2022. Expenses related to Q32’s ADX-097

 

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program decreased as the program was winding down both CMC redevelopment costs of $0.9 million and toxicology and other activities of $0.8 million in the first half of 2023 partially offset by higher clinical costs $0.4 million as the program entered Phase 1 clinical trials, which have higher ongoing costs than the previous pre-clinical studies. Expenses related to Q32’s bempikibart program decreased due to decrease in toxicology cost of $1.9 million as the program substantially completed its six-month toxicology study in fiscal year 2022 and a decrease in CMC and regulatory costs of $0.3 million offset by an increase of $1.6 million in clinical spend. Q32 completed its Phase 1 clinical trial in the first half of 2022 and subsequently incurred start-up costs related to two planned Phase 2 trials, the first of which was initiated in October 2022 which expenses increased as the Phase 2 trial advanced throughout 2023.

The decrease in personnel-related and consultant costs were primarily related to a decrease in headcount and use of consultants. Personnel-related and consultant costs for the nine months ended September 30, 2023 and 2022 included stock-based compensation expense of $0.4 million and $0.3 million, respectively. The decrease in indirect research and development costs related to facility and other costs primarily associated with Q32 incurring additional facility and start-up costs associated with moving into a new office and lab facility during 2022.

General and Administrative Expenses

General and administrative expenses were $7.1 million for the nine months ended September 30, 2023, compared to $7.6 million for the nine months ended September 30, 2022. The decrease is due to lower recruiting costs and market research studies.

Change in Fair Value of Convertible Notes

Change in the fair value of the convertible notes was $5.0 million for the nine months ended September 30, 2023, compared to $1.0 million for the nine months ended September 30, 2022.

Other Income (Expense), Net

Other income (expense), net was $0.8 million for the nine months ended September 30, 2023, compared to an expense of $(0.8 million) for the nine months ended September 30, 2022. Other income (expense), net for the nine months ended September 30, 2023 is made up primarily of interest expense on Q32’s venture debt of $0.4 million offset by interest income of $0.9 million. The increase in other income (expense), net is due to a higher average cash balance resulting in higher interest income for the nine months ended September 30, 2023.

Provision for income taxes

Provision for income taxes was $65 thousand for the nine months ended September 30, 2023 compared to $45 thousand for the nine months ended September 30, 2022.

 

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Comparison of the Years Ended December 31, 2022 and 2021

The following table summarizes Q32’s results of operations for the years ended December 31, 2022 and 2021:

 

     Year Ended
December 31,
        
     2022      2021      Change  
     (in thousands)         

Collaboration arrangement revenue

   $ 6,651      $ —        $ 6,651  

Operating expenses:

        

Research and development

     35,814        29,929        5,885  

General and administrative

     10,062        6,764        3,298  
  

 

 

    

 

 

    

 

 

 

Total operating expenses

     45,876        36,693        9,183  
  

 

 

    

 

 

    

 

 

 

Loss from operations

     (39,225 )       (36,693 )       (2,532 ) 

Change in fair value of convertible notes

     (2,402 )       —          (2,402 ) 

Other income (expense), net

     (1,120 )       (324 )       (796 ) 
  

 

 

    

 

 

    

 

 

 

Loss before provision for income taxes

     (42,747 )       (37,017 )       (5,730 ) 

Provision for income taxes

     (62 )       (547 )       485  
  

 

 

    

 

 

    

 

 

 

Net loss

   $ (42,809 )     $ (37,564 )     $ (5,245 ) 
  

 

 

    

 

 

    

 

 

 

Collaboration Arrangement Revenue

Q32 recognized $6.7 million of collaboration arrangement revenue for the year ended December 31, 2022. Q32 executed the Horizon Collaboration Agreement in August 2022 and began performing research services. As a result, there is no corresponding activity in the fiscal year ended December 31, 2021.

Research and Development Expenses

The following table summarizes Q32’s research and development expenses for the years ended December 31, 2022 and 2021:

 

     Year Ended
December 31,
        
     2022      2021      Change  
     (in thousands)         

Direct research and development expenses by program:

        

ADX-097

   $ 10,109      $ 13,332      $ (3,223 ) 

Bempikibart

     11,892        7,402        4,490  

Discovery and other

     1,270        252        1,018  

Unallocated expenses:

        

Personnel-related and consulting (including stock-based compensation)

     9,990        7,566        2,424  

Indirect research and development expense

     2,553        1,377        1,176  
  

 

 

    

 

 

    

 

 

 

Total research and development expenses

   $ 35,814      $ 29,929      $ 5,885  
  

 

 

    

 

 

    

 

 

 

Research and development expenses were $35.8 million for the year ended December 31, 2022, compared to $29.9 million for the year ended December 31, 2021. Expenses related to Q32’s ADX-097 program decreased primarily due to a decrease of $4.6 million in costs related to the completion of good manufacturing practice, or GMP, product manufacturing to support Phase 1 and Phase 2 clinical trials, a decrease of $1.5 million for non-clinical toxicology studies, and a decrease in preclinical research of $0.7 million, offset by an increase in

 

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clinical cost of $3.6 million to initiate ADX-097 Phase 1 clinical trials. Expenses related to Q32’s bempikibart program increased primarily due to an increase of $6.5 million in costs related to the initiation and advancement of a Phase 2 clinical trial for bempikibart, a $0.3 million increase in CMC activity to support ongoing product needs and an increase in non-clinical costs of $1.0 million for on-going toxicology studies, offset by a decrease in costs of $3.3 million related to the completion of the Phase 1 clinical study for bempikibart. Discovery and other costs increased by $1.0 million due to an increased focus on new discovery and pipeline activities after ADX-097 entered into clinical trials. Personnel-related and consultant expenses increased by $2.4 million due to higher research and development headcount. Indirect research and development expenses increased by $1.2 million largely associated with the costs related to Q32’s move into a new facility during fiscal year 2022.

General and Administrative Expenses

General and administrative expenses were $10.1 million for the year ended December 31, 2022, compared to $6.8 million for the year ended December 31, 2021. The increase of $3.3 million in general and administrative expenses was primarily due to a $2.8 million increase in personnel-related costs related to higher general and administrative headcount and a $0.4 million increase in legal, audit and other professional services related to ongoing business activities.

Change in Fair Value of Convertible Notes

Change in the fair value of the convertible notes was $2.4 million for the year ended December 31, 2022, compared to zero for the period ended December 31, 2021. Q32 did not have any convertible notes in fiscal 2021.

Other Income (Expense), Net

Other expense, net was $1.1 million for the year ended December 31, 2022, compared to an expense, net of $0.3 million for the year ended December 31, 2021. The increase in expense, net was due to rising higher interest rates on venture debt during the year ending December 31, 2022.

Income taxes

Since inception, Q32 has not recorded any U.S. federal or state income tax benefits for the net losses it has incurred in each year or for its earned research and development tax credits, due to its uncertainty of realizing a benefit from those items. As of December 31, 2022, Q32 had no gross unrecognized tax benefits. During 2022, it amended its prior year tax filings and settled an unrecognized tax benefit recorded in the prior year and primarily driven by transfer pricing reimbursement from the U.S. to Australia including interest and penalties which explains the year-over-year decrease in income tax expenses.

Liquidity and Capital Resources

Sources of Liquidity

Since its inception, Q32 has incurred significant operating losses and negative cash flows from operations. Q32 has not yet commercialized any of its product candidates, which are in various phases of preclinical and clinical development, and it does not expect to generate revenue from sales of any products for several years, if at all. To date, Q32 has funded its operations primarily from proceeds from the sales of its convertible preferred stock, convertible notes, venture debt, and proceeds from the Horizon Collaboration Agreement. From inception through September 30, 2023, Q32 raised $111.4 million in aggregate cash proceeds, net of issuance costs, from the sales of its Series A convertible preferred stock, Series A1 convertible preferred stock and Series B convertible preferred stock and received payments of $55.0 million in connection with its collaboration agreement with Horizon. Q32 also received $30.0 million, net of issuance costs from the sales of convertible notes and $5.5 million from its venture debt. As of September 30, 2023, Q32 had cash and cash equivalents of $36.3 million.

 

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Going Concern

Q32 has incurred significant operating losses since inception and, as of September 30, 2023, had an accumulated deficit of $160.0 million. Q32 expects negative cash flows from operations and net losses for the foreseeable future as it continues to invest significantly in research and development of its product candidates and platform. Q32 expects its existing cash and cash equivalents will not be sufficient to allow Q32 to fund its operating expenses and capital expenditures requirements through at least the next twelve months from the issuance of the consolidated financial statements included herein. Based on its recurring losses from operations incurred since inception, the expectation of continuing operating losses for the foreseeable future, and the need to raise additional capital to finance its future operations, Q32 has concluded that there is substantial doubt about its ability to continue as a going concern within one year after the date that the consolidated financial statements included herein are issued.

Q32 is seeking to complete the proposed Merger with Homology as well as complete a concurrent private placement to raise additional capital. Following the completion of the proposed Merger and the Q32 Pre-Closing Financing, Q32 will also incur additional costs associated with operating as a public company. Accordingly, Q32 will require substantial additional funding to continue its operations. Upon the completion of the proposed Merger and the Q32 Pre-Closing Financing, based on its current operating plan, Q32 believes that its existing cash and cash equivalents should be sufficient to fund its operations through mid-2026. Management based its projections of operating capital requirements on Q32’s current operating plan, which includes several assumptions that may prove to be incorrect, and Q32 may use all of its available capital resources sooner than management expects. Q32 expects to seek to raise additional capital through private or public equity or debt financings, loans or other capital sources, which could include collaborations, partnerships or other marketing, distribution, licensing or other strategic arrangements with third parties, or from grants, and may be required to seek additional capital sooner than planned. However, there can be no assurances that Q32 will be able to raise additional capital from these sources on favorable terms, or at all.

Cash Flows

The following table summarizes the Q32’s cash flows for the periods indicated:

 

     Nine Months Ended
September 30,
     Year Ended
December 31,
 
     2023      2022      2022      2021  
     (in thousands)      (in thousands)  

Net cash used in operating activities

   $ (7,963 )     $ (20,477 )     $ (10,957 )     $ (32,979 ) 

Net cash used in investing activities

     (5 )       (2,485 )       (2,466 )       (157 ) 

Net cash flows provided by financing activities

     331        13,402        30,069        20,105  
  

 

 

    

 

 

    

 

 

    

 

 

 

Increase/(decrease) in cash, cash equivalents and restricted cash

   $ (7,637 )     $ (9,560 )     $ 16,646      $ (13,031 ) 
  

 

 

    

 

 

    

 

 

    

 

 

 

Operating Activities

Q32’s cash flows from operating activities are greatly influenced by Q32’s use of cash for operating expenses and working capital requirements to support Q32’s business. Q32 has historically experienced negative cash flows from operating activities as Q32 invested in developing clinical programs, drug discovery efforts and related infrastructure.

For the nine months ended September 30, 2023, net cash used in operating activities of $8.0 million was primarily due to a net loss of $26.7 million partially offset by a change in net operating assets and liabilities of $12.0 million and net non-cash operating expenses of $6.7 million. The change in net operating assets and liabilities was primary attributable to an increase in deferred revenue, accounts payables and other non-current

 

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assets of $14.4 million, partially offset by a decrease in prepaid expenses and other current assets, operating lease liability and accrued expenses and other current liabilities of $2.4 million. The non-cash operating expenses consisted of a $5.0 million change in fair value of convertible notes, stock-based compensation expense of $0.9 million, non-cash lease expenses of $0.4 million, and depreciation and amortization of $0.4 million.

For the nine months ended September 30, 2022, net cash used in operating activities of $20.5 million was primarily due to a net loss of $33.1 million, partially offset by a change in net operating assets and liabilities of $9.7 million, and net non-cash operating expenses of $2.9 million. The change in net operating assets and liabilities was primary attributable to an increase in deferred revenue, accrued expenses and other current liabilities and prepaid expenses and other current assets of $11.4 million and a decrease in accounts payable, operating lease liability and other non-current assets of $1.7 million. The non-cash operating expenses consisted of a $1.0 million change in fair value of convertible notes, stock-based compensation expense of $0.9 million, non-cash lease expenses of $0.7 million, and depreciation and amortization of $0.3 million.

During the year ended December 31, 2022, net cash used in operating activities of $11.0 million consisted of a net loss of $42.8 million, partially offset by a change in net operating assets and liabilities of $26.9 million and net non-cash operating expenses of $4.9 million. The change in net operating assets and liabilities was primarily attributable to an increase in prepaid expenses, accrued expenses and deferred revenue of $28.4 million, partially offset by a decrease in other current assets, accounts payable and operating lease liability of $1.5 million. The non-cash operating expenses consisted mainly of a $2.4 million change in fair value of convertible notes, stock-based compensation expense of $1.2 million, non-cash lease expenses of $0.8 million and depreciation expense of $0.5 million.

During the year ended December 31, 2021, net cash used in operating activities of $33.0 million consisted of a net loss of $37.6 million and a change in net operating assets and liabilities of $3.7 million, partially offset by net non-cash operating expenses of $0.9 million. The change in net operating assets and liabilities was primary attributable to an increase in prepaid expenses, other noncurrent assets, accounts payable and accrued expenses and other current liabilities of $3.7 million. The non-cash operating expenses consisted mainly of stock-based compensation expense of $0.8 million and amortization of debt costs of $0.1 million.

Investing Activities

For the nine months ended September 30, 2023 and 2022, and the years ended December 31, 2022 and 2021, net cash used in investing activities consisted of purchases for property and equipment.

Financing Activities

For the nine months ended September 30, 2023, net cash provided by financing activities consisted of $5.5 million of proceeds from the borrowings under a new loan and security agreement and $31 thousand of proceeds from the exercise of common stock options offset by payments of $5.3 million associated with the repayment of Q32’s initial loan and security agreement.

For the nine months ended September 30, 2022, net cash provided by financing activities consisted of $13.3 million of proceeds from the issuance of Q32’s convertible notes and $69 thousand of proceeds from the exercise of common stock options.

For the year ended December 31, 2022, net cash provided by financing activities consisted of $30.0 million of proceeds from the issuance of Q32’s convertible notes and $69 thousand of proceeds from the exercise of common stock options.

For the year ended December 31, 2021, net cash provided by financing activities consisted of $20.0 million for proceeds from the issuance of Q32’s Series B convertible preferred stock and $0.1 million of proceeds from the exercise of common stock options.

 

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Pre-Closing Financing

In connection with the Merger Agreement, certain third parties have entered into the Q32 Pre-Closing Financing as described above under “—Recent Developments—Proposed Merger with Homology and the Q32 Pre-Closing Financing.” The Q32 Pre-Closing Financing is contingent upon, and will occur immediately prior to, the closing of the Merger, subject to customary closing conditions. Shares of Q32 common stock issued pursuant to the Q32 Pre-Closing Financing will be converted into shares of Homology common stock in accordance with the exchange ratio at the Effective Time as calculated pursuant to the Merger Agreement.

Future Funding Requirements

Management expects Q32’s expenses to increase substantially in connection with its ongoing research and development activities, particularly as it advances the preclinical activities and clinical trials of its product candidates. In addition, upon the completion of the Merger, Q32 expects to incur additional costs associated with operating as a public company.

Because of the numerous risks and uncertainties associated with research, development and commercialization of product candidates, Q32 is unable to estimate the exact amount and timing of its capital requirements. Q32’s future funding requirements will depend on many factors, including:

 

  •  

the scope, timing, progress, results, and costs of researching and developing bempikibart and ADX-097, and conducting larger and later-stage clinical trials;

 

  •  

the scope, timing, progress, results, and costs of researching and developing other product candidates that Q32 may pursue;

 

  •  

the costs, timing, and outcome of regulatory review of Q32’s product candidates;

 

  •  

the costs of future activities, including product sales, medical affairs, marketing, manufacturing, and distribution, for any of Q32’s product candidates for which it receives marketing approval;

 

  •  

the costs of manufacturing commercial-grade products and sufficient inventory to support commercial launch;

 

  •  

the revenue, if any, received from commercial sale of Q32’s products, should any of product candidates receive marketing approval;

 

  •  

the cost and timing of attracting, hiring, and retaining skilled personnel to support Q32’s operations and continued growth;

 

  •  

the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing Q32’s intellectual property rights and defending intellectual property-related claims;

 

  •  

Q32’s ability to establish, maintain, and derive value from collaborations, partnerships or other marketing, distribution, licensing, or other strategic arrangements with third parties on favorable terms, if at all;

 

  •  

the extent to which Q32 acquires or in-licenses other product candidates and technologies, if any; and

 

  •  

the costs associated with operating as a public company.

A change in the outcome of any of these or other factors with respect to the development of any of Q32’s product candidates could significantly change the costs and timing associated with the development of that product candidate. Furthermore, Q32’s operating plans may change in the future, and Q32 may need additional capital to meet the capital requirements associated with such operating plans.

Q32 believes that, based on its current operating plan, the anticipated net proceeds of the Q32 Pre-Closing Financing, together with the combined company’s cash and cash equivalents will enable Q32 to fund its operating expenses and capital expenditure requirements into mid-2026. Management based its projections of operating capital requirements on Q32’s current operating plan, which includes several assumptions that may prove to be incorrect, and Q32 may use all of its available capital resources sooner than management expects.

 

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To complete the development of Q32’s product candidates and to build the sales, marketing and distribution infrastructure that management believes will be necessary to commercialize product candidates, if approved, Q32 will require substantial additional capital. Accordingly, until such time that Q32 can generate a sufficient revenue from product sales or other sources, if ever, management expects to seek to raise any necessary additional capital through private or public equity or debt financings, loans or other capital sources, which could include income from collaborations, partnerships or other marketing, distribution, licensing or other strategic arrangements with third parties, or from grants. To the extent that Q32 raises additional capital through equity financings or convertible debt securities, the ownership interest of its stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of its common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting Q32 ability to take specific actions, including restricting its operations and limiting its ability to incur liens, issue additional debt, pay dividends, repurchase its own common stock, make certain investments or engage in merger, consolidation, licensing, or asset sale transactions. If Q32 raises capital through collaborations, partnerships, and other similar arrangements with third parties, it may be required to grant rights to develop and market product candidates that Q32 would otherwise prefer to develop and market themselves. Q32 may be unable to raise additional capital from these sources on favorable terms, or at all. Q32’s ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from recent bank failures. The failure to obtain sufficient capital on acceptable terms when needed could have a material adverse effect on Q32’s business, results of operations or financial condition, including requiring Q32 to delay, reduce or curtail its research, product development or future commercialization efforts. Q32 may also be required to license rights to product candidates at an earlier stage of development or on less favorable terms than Q32 would otherwise choose. Management cannot provide assurance that Q32 will ever generate positive cash flow from operating activities.

Contractual Obligations and Commitments

Lease Obligations

Q32 leases space under an operating lease for administrative offices and lab space in Waltham, Massachusetts, which expires in December 2031.

The following table summarizes Q32’s contractual obligations and commitments as of September 30, 2023 (in thousands):

 

     Payments Due by Period  
     Total      Less
than 1
Year
     1 to 3
years
     3 to 5
years
     More
than 5
years
 

Operating lease obligation

   $ 9,399      $ 249      $ 3,181      $ 3,475      $ 2,494  

Q32 has agreements with certain vendors for various services, including services related to preclinical and clinical operations and support, for which Q32 is not contractually able to terminate for convenience and avoid any and all future obligations to the vendors. Q32’s most significant contracts relate to agreements with CROs for clinical trials and preclinical studies and CDMOs, which Q32 enters into in the normal course of business. Certain agreements provide for termination rights subject to termination fees or wind down costs. Under such agreements, Q32 is contractually obligated to make certain payments to vendors to reimburse them for their unrecoverable outlays incurred prior to cancellation. The exact amounts of such obligations are dependent on the timing of termination and the exact terms of the relevant agreement and cannot be reasonably estimated. Q32 does not include these payments in the table above as they are not fixed and estimable.

In addition, Q32 enters into standard indemnification agreements and/or indemnification sections in other agreements in the ordinary course of business. Pursuant to these agreements, Q32 agrees to indemnify, hold

 

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harmless and reimburse the indemnified party for losses suffered or incurred by the indemnified party, generally its business partners. The term of these indemnification agreements is generally perpetual upon execution of the agreement. The maximum potential amount of future payments Q32 could be required to make under these indemnification agreements cannot be reasonably estimated and therefore is not included in the table above.

Collaboration and License Agreements

ADX-097 - License Agreement – The Regents of the University of Colorado

In August 2017, Q32 entered into an exclusive license agreement, as amended in February 2018, September 2018, and April 2019, or the Colorado License Agreement, with The Regents of the University of Colorado, or Colorado, pursuant to which Q32 obtained worldwide, royalty-bearing, sublicensable licenses under certain patents and know-how owned by Colorado and Medical University of South Carolina, or MUSC, relating to the research, development and commercialization of ADX-097. The licenses granted to Q32 are exclusive with respect to certain patent families and know-how and non-exclusive with certain other patent families and know-how. The licenses granted to Q32 are also subject to certain customary retained rights of Colorado and MUSC and rights of the United States government owing to federal funding giving rise to inventions covered by the licensed patents. Q32 agreed to use commercially reasonable efforts to develop, manufacture and commercialize ADX-097, including by using commercially reasonable efforts to achieve specified development and regulatory milestones by specified dates.

In addition, Q32 agreed to pay Colorado (i) development and sales milestone payments in an aggregate amount of up to $2.2 million per licensed product for the first three products, (ii) tiered royalty rates on cumulative net sales of licensed products in the low single digit percentages, (iii) 15% of sublicense income and (iv) ongoing fees associated with the prosecution, maintenance, or filing of the licensed patents. Q32’s obligation to pay royalties to Colorado commences, on a licensed product-by-licensed product and country-by-country basis, from the first commercial sale of a licensed product in any country and expires on the later of (i) the last to expire valid claim within the licensed patents covering such licensed product in such country, and (ii) 20 years following the effective date of the Colorado License Agreement, or April 2037, or the Royalty Term.

Unless earlier terminated by either party pursuant to its terms, the Colorado License Agreement will expire upon the expiration of the Royalty Term in all countries. Q32 may terminate the Colorado License Agreement for convenience upon providing prior written notice to Colorado. Colorado may terminate the Colorado License Agreement or convert Q32’s exclusive license to a non-exclusive license if Q32 breaches certain obligations under the Colorado License Agreement and fails to cure such breach. The Colorado License Agreement will terminate automatically upon Q32’s dissolution, insolvency, or bankruptcy. Q32 has the right to terminate the agreement for any reason upon written notice, and therefore, this agreement has not been included in the discussion above.

Bempikibart - License Agreement – Bristol-Myers Squibb Company

In September 2019, Q32 entered into a license agreement, as amended in August 2021 and July 2022, or the BMS License Agreement, with Bristol-Myers Squibb Company, or BMS, pursuant to which Q32 obtained sublicensable licenses from BMS to research, develop and commercialize licensed products, including bempikibart, for any and all uses worldwide. The licenses granted to Q32 are exclusive with respect to BMS’s patent rights and know-how relating to certain antibody fragments (including certain fragments of bempikibart) and non-exclusive with respect to BMS’s patent rights and know-how relating to the composition of matter and use of a specific region of bempikibart. BMS retained the right for it and its affiliates to use the exclusively licensed patents and know-how for internal, preclinical research purposes. Under the BMS License Agreement, Q32 is prohibited from engaging in certain clinical development or commercialization of any antibody other than a licensed compound with the same mechanism of action until the earlier of the expiration of Q32’s obligation to pay BMS royalties or September 2029.

 

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In consideration for the license, Q32 made an upfront payment to BMS of $8 million, issued 6,628,788 Series A preferred shares to BMS and agreed to use commercially reasonable efforts to develop and commercialize at least one licensed product in key geographic markets. In addition, Q32 agreed to pay BMS (i) development and regulatory milestone payments in aggregate amounts ranging from $32 million to $49 million per indication for the first three indications and commercial milestone payments in an aggregate amount of up to $215 million on net sales of licensed products, (ii) tiered royalties ranging from rates in the mid-single digit percentages to up to 10% of net sales, with increasing rates depending on the cumulative net sales, (iii) up to 60% of sublicense income, which percentage decreases based on the development stage of bempikibart at the time of the sublicensing event, and (iv) ongoing fees associated with the prosecution, maintenance, or filing of the licensed patents.

Q32’s obligation to pay BMS royalties under subsection (ii) above commences, on a licensed product-by-licensed product and country-by-country basis, on the first commercial sale of a licensed product in a country and expires on the later of (x) 12 years from the first commercial sale of such Licensed Product in such country, (y) the last to expire licensed patent right covering bempikibart or such licensed product in such country, and (z) the expiration or regulatory or marketing exclusivity for such licensed product in such country, or the Royalty Term). If Q32 undergoes a change of control prior to certain specified phase of development, the development and milestone payments are subject to increase by a low double digit percentage and the royalty rates are subject to increase by a low sub-single digit percentage.

Unless terminated earlier by either party pursuant to its terms, the BMS License Agreement will expire on a country-by-country and licensed product-by-licensed product basis upon the expiration of the last to expire Royalty Term with respect to such licensed product in such country. Either party may terminate the BMS License Agreement for the other party’s material breach, subject to a specified notice and cure period. BMS may terminate the BMS License Agreement if Q32 fails to meet its diligence obligations under the BMS License Agreement, for Q32’s insolvency, or if Q32 or its affiliates challenges the validity, scope, enforceability, or patentability of any of the licensed patents. Q32 may terminate the BMS License Agreement for any reason upon prior written notice to BMS, with a longer notice period if a licensed product has received regulatory approval. If the BMS Agreement is terminated for Q32’s material breach, BMS will regain rights to bempikibart and Q32 must grant BMS an exclusive license under Q32’s patent rights covering bempikibart, subject to a low single digit percentage royalty on net sales of bempikibart payable to Q32 by BMS. Q32 has the right to terminate the agreement for any reason upon written notice, and therefore, this agreement has not been included in the discussion above.

Bempikibart – Collaboration and Option Agreement, Asset Purchase Agreement and Termination Agreement – Horizon Therapeutics Ireland DAC)

From August 2022 until November 2023, Q32 was a party to the Collaboration and Option Agreement, or the Horizon Collaboration Agreement, and the Asset Purchase Agreement, or the Purchase Agreement, and together with the Horizon Collaboration Agreement, the Horizon Agreements, each with Horizon, pursuant to which Q32 received $55.0 million in initial consideration and staged development funding to complete two ongoing Phase 2 trials for bempikibart, and granted Horizon an option to acquire the bempikibart program at a prespecified price, subject to certain adjustments.

In October 2023, Amgen completed the acquisition of Horizon plc. Following its acquisition of Horizon plc, Q32 agreed with Amgen to mutually terminate the Horizon Agreements and in November 2023, Q32 and Horizon entered into a termination agreement, or the Horizon Termination Agreement, pursuant to which Horizon’s option to acquire the bempikibart program was terminated. As a result, Q32 retained all initial consideration and development funding received under the Horizon Collaboration Agreement and regained full development and commercial rights to bempikibart. In consideration for the Horizon Termination Agreement, Q32 agreed to pay Horizon regulatory and sales milestones payments of up to an aggregate amount of $75.1 million upon the first achievement of certain regulatory and sales milestones with respect to bempikibart.

 

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Critical Accounting Policies and Significant Judgments and Estimates

Management’s discussion and analysis of its financial condition and results of operations is based on its consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of these consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, as well as the reported expenses incurred during the reporting periods. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these consolidated financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. Actual results could materially differ from those estimates.

While Q32’s significant accounting policies are described in more detail in the notes to its consolidated financial statements and the notes to its unaudited interim condensed consolidated financial statements appearing elsewhere in this proxy statement/prospectus, management believes that the following accounting policies are those most critical to the judgments and estimates used in the preparation of Q32’s consolidated financial statements.

Revenue Recognition

Under ASC Topic 606, Revenue from Contracts with Customers (Topic 606), an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. Q32 only applies the five-step model to contracts when it is probable that the entity will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer.

Once a contract is determined to be within the scope of Topic 606, Q32 assesses the goods or services promised within each contract and determines those that are performance obligations.

Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. Q32 assesses if these options provide a material right to the customer and if so, they are considered performance obligations. The identification of material rights requires judgments related to the determination of the value of the underlying good or service relative to the option exercise price. The exercise of a material right is accounted for as a contract modification for accounting purposes.

Q32 assesses whether each promised good or service is distinct for the purpose of identifying the performance obligations in the contract. This assessment involves subjective determinations and requires management to make judgments about the individual promised goods or services and whether such are separable from the other aspects of the contractual relationship. Promised goods and services are considered distinct provided that: (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (that is, the good or service is capable of being distinct) and (ii) the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (that is, the promise to transfer the good or service is distinct within the context of the contract). In assessing whether a promised good or service is distinct, Q32 considers factors such as the license

 

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terms, the research, manufacturing and commercialization capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace. Q32 also considers the intended benefit of the contract in assessing whether a promised good or service is separately identifiable from other promises in the contract. If a promised good or service is not distinct, an entity is required to combine that good or service with other promised goods or services until it identifies a bundle of goods or services that is distinct.

The transaction price is determined and allocated to the identified performance obligations in proportion to their stand-alone selling prices (SSP) on a relative SSP basis. SSP is determined at contract inception and is not updated to reflect changes between contract inception and when the performance obligations are satisfied. Determining the SSP for performance obligations requires significant judgment. In developing the SSP for a performance obligation, Q32 considers applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer and estimated costs. Q32 validates the SSP for performance obligations by evaluating whether changes in the key assumptions used to determine the SSP will have a significant effect on the allocation of arrangement consideration between multiple performance obligations.

If the consideration promised in a contract includes a variable amount, Q32 estimates the amount of consideration to which it will be entitled in exchange for transferring the promised goods or services to a customer. Q32 determines the amount of variable consideration by using the expected value method or the most likely amount method. The amount of variable consideration included in the transaction price is constrained to the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty related to the variable consideration is resolved. At the end of each subsequent reporting period, Q32 re-evaluates the estimated variable consideration included in the transaction price and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment.

If an arrangement includes development and regulatory milestone payments, Q32 evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within Q32’s control or the licensee’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received.

For arrangements with licenses of intellectual property that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, Q32 recognizes royalty revenue and sales-based milestones at the later of (i) when the related sales occur, or (ii) when the performance obligation to which the royalty has been allocated has been satisfied.

In determining the transaction price, Q32 adjusts consideration for the effects of the time value of money if the timing of payments provides Q32 with a significant benefit of financing. Q32 does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less.

Q32 recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) each performance obligation is satisfied, either at a point in time or over time, and if over time recognition is based on the use of an output or input method.

Research and Development Expenses and Related Accrued Expenses

Research and development costs are expensed as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including salaries, stock-based

 

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compensation and benefits, costs for clinical research organizations, manufacturing expenses and costs of other outside vendors and other outsourced activities; laboratory supplies; technology licenses, software and other information technology support; facilities and depreciation.

Upfront payments and milestone payments made for the licensing of technology are expensed as research and development expenses in the period in which they are incurred. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed.

As part of the process of preparing Q32’s consolidated financial statements, management is required to estimate its accrued research and development expenses. This process involves reviewing open contracts and purchase orders, communicating with its personnel to identify services that have been performed on its behalf and estimating the level of service performed and the associated costs incurred for the services when Q32 has not yet been invoiced or otherwise notified of the actual costs. The majority of its service providers invoice Q32 in arrears for services performed, on a pre-determined schedule or when contractual milestones are met; however, some require advanced payments. Management makes estimates of its accrued expenses as of each balance sheet date in its financial statements based on facts and circumstances known to Q32 at that time. Management periodically confirms the accuracy of the estimates with the service providers and make adjustments if necessary. Examples of estimated accrued research and development expenses include fees paid to:

 

  •  

CROs and investigative sites in connection with performing research services, preclinical studies and clinical trials;

 

  •  

vendors, including research laboratories, in connection with preclinical and clinical development activities; and

 

  •  

vendors, including CDMOs, related to product manufacturing, development and distribution of preclinical studies and clinical trial materials.

Management bases the expense recorded related to contract research and manufacturing on its estimates of the services received and efforts expended pursuant to quotes and contracts with multiple CDMOs and CROs that supply materials and conduct services. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to its vendors will exceed the level of services provided and result in a prepayment of the expense. In accruing service fees, management estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, management adjusts the accrual or prepaid expense accordingly. Although Q32 does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period.

Convertible Notes

Q32 accounts for all Convertible Notes issued under the fair value option election of ASC 825, Financial Instruments (ASC 825). The financial instrument is initially measured at its issue-date estimated fair value and then subsequently remeasured at estimated fair value on a recurring basis at each reporting period date. The estimated fair value adjustment is recognized within other income (expense) in the accompanying consolidated statements of operations and the portion of the fair value adjustment attributed to a change in the instrument-specific credit risk is recognized as a component of other comprehensive loss, if any. The fair value is based on significant inputs not observable in the market, namely potential financing scenarios, the likelihood of such scenarios, the expected time for each scenario to occur, and the required market rates of return utilized in modeling these scenarios. Q32 recorded $5.0 million. and $2.4 million loss related to the change in fair value of the Convertible Notes for the nine months ended September 30, 2023 and for the year ended December 31, 2022, respectively.

 

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Stock-Based Compensation Expense

Q32 accounts for stock-based awards in accordance with ASC Topic 718, Compensation—Stock Compensation (ASC 718). ASC 718 requires all stock-based awards issued to employees and members of Q32’s board of directors (the “Board”) for their services to be recognized as expense in the statements of operations based on their grant date fair values. Q32 uses the value of its common stock to determine the fair value of its stock-based awards. For stock options and time-based restricted stock awards, Q32 expenses the fair value of the awards on a straight-line basis over each award’s service period, which is generally the period in which the related services are received. For performance-based stock awards, Q32 uses the accelerated attribution method to expense the awards over the implicit service period based on the probability of achieving the performance conditions. Q32 accounts for stock-based awards to non-employees consistently with the accounting for awards to employees and measures stock-based awards granted to non-employees based on their grant date fair value and recognizes the resulting value as stock-based compensation expense during the period the related services are rendered. Q32 accounts for forfeitures as they occur.

Fair Value of Stock-Based Awards

Q32 determines the fair value of restricted stock awards in reference to the fair value of its common stock less any applicable purchase price. Management estimates the fair value of Q32’s stock options granted with service-based conditions using the Black-Scholes option pricing model, which requires inputs of subjective assumptions, including: (i) the expected volatility of our common stock, (ii) the expected term of the award, (iii) the risk-free interest rate, (iv) expected dividends and (v) the fair value of its common stock. Due to the lack of a public market for the trading of our common stock and a lack of company-specific historical and implied volatility data, management bases the estimate of expected volatility on the historical volatilities of a representative group of publicly traded guideline companies. For these analyses, it selects companies with comparable characteristics and with historical share price information that approximates the expected term of the stock-based awards. Management computes the historical volatility data using the daily closing prices for the selected companies’ shares during the equivalent period that approximates the calculated expected term of its stock options. Management will continue to apply this method until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. Q32 estimates the expected term of its stock options granted to employees and directors using the simplified method, whereby the expected term equals the average of the vesting term and the original contractual term of the option. It utilizes this method as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term. The expected dividend yield is assumed to be zero as Q32 has no current plans to pay any dividends on common stock. Q32 has elected to use the expected term for stock options granted to non-employees, using the simplified method, as the basis for the expected term assumption. However, we may elect to use either the contractual term or the expected term for stock options granted to non-employees on an award-by-award basis.

Determination of the Fair Value of Common Stock

Given the absence of an active market for its common stock, the fair values of the shares of common stock underlying Q32’s stock-based awards were determined on each grant date by the Board with input from management, considering its most recently available third-party valuations of its common stock and the Board’s assessment of additional objective and subjective factors that it believed were relevant and which may have changed from the date of the most recent valuation through the grant date. Historically, these independent third-party valuations of its equity instruments were performed contemporaneously with identified value inflection points. The third-party valuations were prepared in accordance with the framework of the American Institute of Certified Public Accountants’ Technical Practice Aid, Valuation of Privately-Held Company Equity Securities Issued as Compensation, or the Practice Aid. The Practice Aid identifies various available methods for allocating enterprise value across classes and series of capital stock to determine the estimated fair value of common stock at each valuation date.

 

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In addition to considering the results of these third-party valuations, the Board considered various objective and subjective factors to determine the fair value of Q32’s equity instruments as of each grant date, which may be later than the most recently available third-party valuation date, including:

 

  •  

the lack of liquidity of its equity as a private company;

 

  •  

the prices of its convertible preferred stock sold to outside investors in arm’s length transactions and the rights, preferences and privileges of its convertible preferred stock as compared to those of its common stock, including the liquidation preferences of its convertible preferred stock;

 

  •  

the progress of its research and development efforts, including the status of preclinical studies and clinical trials for its product candidates;

 

  •  

its stage of development and business strategy and the material risks related to its business and industry;

 

  •  

the achievement of enterprise milestones, including entering into strategic collaborative and license agreements;

 

  •  

the valuation of publicly traded companies in the life sciences and biotechnology sectors, as well as recently completed mergers and acquisitions of peer companies;

 

  •  

any external market conditions affecting the biotechnology industry and trends within the biotechnology industry;

 

  •  

the likelihood of achieving a liquidity event, such as an initial public offering or a sale of Q32, given prevailing market conditions; and

 

  •  

the analysis of initial public offerings and the market performance of similar companies in the biotechnology industry.

For financial statement purposes, management performed common stock valuations at various dates, which resulted in valuation of its common stock of $0.81 per share as of September 15, 2023, $0.36 per share as of September 30, 2022, and $0.35 per share as of December 27, 2021. There are significant judgments and estimates inherent in these valuations. These judgments and estimates include assumptions regarding its future operating performance, the stage of development of our product candidates, the timing and probability of a potential initial public offering or other liquidity event and the determination of the appropriate valuation methodology at each valuation date. The assumptions underlying these valuations represent management’s best estimates, which involve inherent uncertainties and the application of management judgment. As a result, if factors or expected outcomes change and management uses significantly different assumptions or estimates, its stock-based compensation expense could be materially different.

Once a public trading market for its common stock has been established in connection with the completion of the merger, it will no longer be necessary for the Board to estimate the fair value of its common stock in connection with its accounting for granted stock options and restricted stock awards, as the fair value of its common stock will be determined based on the trading price of its common stock on Nasdaq.

Valuation Methodologies

Q32 used a hybrid of the probability-weighted expected returns method, or PWERM, and the Option Pricing Method, or OPM, when allocating enterprise value to classes of securities.

Under the PWERM, the value of an enterprise, and its underlying common stock are estimated based on an analysis of future values for the enterprise, assuming various outcomes. The value of the common stock is based on the probability-weighted present value of expected future investment returns considering each of the possible outcomes and the rights of each class of equity. The future values of the common stock under the various outcomes are discounted back to the valuation date at an appropriate risk-adjusted discount rate and then probability weighted to determine the value for the common stock.

 

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The OPM treats common stock and preferred stock as call options on the enterprise’s equity value, with exercise prices based on the liquidation preferences of the preferred stock. Under this method, the common stock has value only if the funds available for distribution to stockholders exceed the value of the liquidation preferences at the time of a liquidity event. The Black-Scholes option pricing model is used to price the call option, and the model includes assumptions for the time to liquidity and the volatility of equity value.

The hybrid method is a blend of the PWERM and OPM, estimating the probability-weighted value across multiple scenarios and then using the OPM to estimate the allocation of value within one or more of those scenarios. When using the hybrid method, Q32 assumed three scenarios: an early initial public offering, or IPO, scenario, a late IPO scenario and a remain-private scenario. The IPO scenarios reflect an exit or liquidity event by means of a sale of common stock to the public where the estimated IPO price is based, in part, on a review of recent IPO information of comparable public companies at a similar stage to us at the time of their IPO. The comparable IPO companies considered for these scenarios consisted of biopharmaceutical companies at various stages of development ranging from discovery stage to completion of early-stage clinical trials. Additional comparable IPO companies at similar product development stages in the broader biopharmaceutical industry were also considered. We converted the estimated future value in an IPO to present value using a risk-adjusted discount rate. The equity value for the remain-private scenario was estimated using the discounted cash flow method or by back-solving to the price of recently issued preferred stock. In the remain-private scenario, value is allocated to our equity securities using the OPM. In the OPM, volatility is estimated based on the trading histories of selected guideline public companies. The relative probability of each scenario was determined based on an assessment of then-current market conditions and our expectations as to timing and prospects of an IPO.

Recently Issued and Adopted Accounting Pronouncements

A description of recently issued and certain recently adopted accounting pronouncements that have or may potentially impact Q32’s financial position and results of operations is included in Note 2 to Q32’s audited consolidated financial statements and in Note 2 to its unaudited condensed consolidated financial statements both appearing elsewhere in this proxy statement/prospectus.

Quantitative and Qualitative Disclosures About Market Risk

As of December 31, 2022 and 2021, and September 30, 2023, Q32 had cash, cash equivalents, restricted cash, and restricted cash equivalents of $49.5 million, $32.9 million, and $41.9 million, respectively, which consisted of cash and money market funds. Interest income is sensitive to changes in the general level of interest rates; however, due to the nature of these investments, an immediate 10% change in market interest rates would not have a material effect on the fair market value of Q32’s cash or cash equivalents.

All of Q32’s employees and operations are currently located in the United States. Q32 has, from time to time, engaged in contracts with contractors or other vendors in a currency other than the U.S. dollar. To date, Q32 has had minimal exposure to fluctuations in foreign currency exchange rates as the time period between the date that transactions are initiated, and the date of payment or receipt of payment is generally of short duration. Accordingly, Q32 believes it does not have a material exposure to foreign currency risk.

Inflation generally affects Q32 by increasing its cost of labor. Q32 does not believe that inflation had a material effect on its business, financial condition or results of operations during the years ended December 31, 2022 or 2021 or during the nine months ended September 30, 2023 and 2022.

 

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MANAGEMENT FOLLOWING THE MERGER

Executive Officers and Directors

Executive Officers and Directors of the Combined Company Following the Merger

The combined company’s board of directors will initially be fixed at nine members, consisting of (i) seven members designated by the Q32 board of directors, including                current Q32 board members, namely Jodie Morrison,                ,                , and                , and (ii) two current Homology board members, namely Arthur Tzianabos and Mary Thistle. The staggered structure of the current Homology board of directors will remain in place for the combined company following the completion of the Merger. The Homology board of directors has determined that each of the directors other than Jodie Morrison and                meet the Nasdaq independence requirements.

The following table lists the names and ages, as of November 30, 2023, and positions of the individuals who are expected to serve as executive officers and directors of the combined company upon completion of the Merger:

 

Name     Age      

Position

Executive Officers:

     

Jodie Morrison

     48      Chief Executive Officer and Director

Lee Kalowski

     42      Interim Chief Financial Officer

Jason A. Campagna

     53      Chief Medical Officer

Shelia M. Violette

     63      Chief Scientific Officer and President of Research

Non-Employee Directors:

     

Arthur Tzianabos

     60      Director

Mary Thistle

     64      Director

Executive Officers

Jodie Morrison. Ms. Morrison has served as a member of Q32’s board of directors since September 2022. Ms. Morrison is currently the Chief Executive Officer of Q32, where she has been employed since September 2022. Prior to joining Q32, Ms. Morrison was a Venture Partner at Atlas Venture from July 2021 to September 2022, Chief Executive Officer of Cadent Therapeutics from January 2019 to March 2021, and Chief Executive Officer of Keryx Biopharmaceuticals from April 2018 until December 2018. Ms. Morrison has also served as an Advisor at Atlas Venture since January 2019. She also currently sits as Chair of the board of directors for Ribon Therapeutics and on the board of directors of Rectify Pharmaceuticals. She has previously held board positions at Aileron Therapeutics, Akebia and Keryx. Ms. Morrison received a certificate through the Greater Boston Executive Program at the MIT Sloan School of Management, a clinical research certification from Boston University School of Medicine, and B.A. in Neuroscience from Mount Holyoke College. Q32 believes Ms. Morrison’s experience in the biopharmaceutical industry provides her with the qualifications and skills to serve as a director of the combined company.

Lee Kalowski. M.B.A. Mr. Kalowski has served as Q32’s Interim Chief Financial Officer since October 2023 and has also served as a consultant to the life sciences industry since October 2023. Prior to joining Q32, Mr. Kalowski served as Chief Financial Officer from July 2017 to June 2023 and as President from January 2019 to June 2023 of Bicycle Therapeutics. Previously, Mr. Kalowski was Chief Financial Officer of Tokai Pharmaceuticals. Prior to Tokai, Mr. Kalowski served in global biotechnology equity research at Credit Suisse, where he covered companies in the biopharmaceutical industry as a Senior Analyst. Mr. Kalowski received a B.A. in biology and economics from Union College and an M.B.A. from The Wharton School of the University of Pennsylvania.

Jason A. Campagna, M.D., Ph.D.. Dr. Campagna is currently the Chief Medical Officer of Q32, where he has been employed since March 2021. Prior to this role, Dr. Campagna was Chief Medical Officer at Intercept

 

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Pharmaceuticals from November 2019 to March 2021, and where he also served as Senior Vice President and Global NASH Lead from August 2016 to November 2019. From December 2020 to March 2023, Dr. Campagna served on the board of directors for Plantable Health. Dr. Campagna holds an M.D./Ph.D. in Molecular and Cellular Pharmacology from the University of Miami Miller School of Medicine and a B.S. in Biology from the University of Miami.

Shelia M. Violette, Ph.D. Dr. Violette is currently the Chief Scientific Officer and President of Research of Q32, where she has been employed since September 2017. Prior to this role, Dr. Violette was an Entrepreneur in Residence at Atlas Venture from November 2016 to September 2017, and she has continued to serve as an Advisor since September 2017. From July 2016 to June 2021, Dr. Violette was an Adjunct Associate Professor at Yale University School of Medicine’s Department of Internal Medicine. Prior to that position, Dr. Violette held several senior roles in research at Biogen from March 2012 to October 2016. Dr. Violette currently serves on the Scientific Advisory Boards of Triveni Bio Inc., Morphic Therapeutics, Inc., Mediar Therapeutics Inc., and APIE Therapeutics Inc. Dr. Violette also served on the board of directors of Cytimmune Science from October 2021 to June 2023, and she was on the Scientific Advisory Boards of Scholar Rock Holding Corporation from April 2017 to December 2022, Enleofen Bio Pte Ltd from June 2017 to April 2020, and NuMedii, Inc. from February 2018 to February 2019. Dr. Violette holds a Ph.D. in Pharmacology from Yale University and a B.S. in Pharmacology from the Massachusetts College of Pharmacy.

Non-Employee Directors

Arthur O. Tzianabos, Ph.D. Dr. Tzianabos has served as the Chairman of Homology’s board of directors since September 2022 and he has served as a member of Homology’s board of directors since April 2016. Dr. Tzianabos has served as Venture Partner at 5AM Ventures since September 2022. Dr. Tzianabos was Homology’s President and Chief Executive Officer from April 2016 to September 2022. Dr. Tzianabos joined Homology from OvaScience, Inc., a biotechnology company (which has since merged with and into Millendo Therapeutics, Inc.), where he served as President and Chief Scientific Officer from September 2013 to March 2016. Prior to OvaScience, Dr. Tzianabos spent eight years at Shire plc, a biotechnology company, where he served in positions of increasing responsibility, including Senior Director, Discovery Research, Vice President, Program Management and Senior Vice President and Head, Research and Early Development. From 1992 to 2005, Dr. Tzianabos was a faculty member at Harvard Medical School and maintained laboratories at the Channing Laboratory, Brigham and Women’s Hospital and the Department of Microbiology and Molecular Genetics at Harvard Medical School. Dr. Tzianabos has served as a director of Stoke Therapeutics, Inc., a public biotechnology company, since April 2018. Dr. Tzianabos previously served as chairman of the board of directors of Akouos, Inc., a public biotechnology company, from July 2018 until its acquisition by Eli Lilly in December 2022, and a director of BIND Therapeutics, Inc., a biotechnology company, from October 2015 until its acquisition by Pfizer in July 2016. Dr. Tzianabos holds a B.S. in Biology from Boston College and a Ph.D. in Microbiology from the University of New Hampshire, and completed a Post-Doctoral Fellowship in Immunology at Harvard Medical School. Dr. Tzianabos’ extensive academic and clinical experience, as well as his knowledge of Homology and the industry, qualifies him to serve on the combined company’s board of directors.

Mary Thistle. Ms. Thistle has served as a member of Homology’s board of directors since 2018. Ms. Thistle has served as Special Advisor to the Bill & Melinda Gates Medical Research Institute, a non-profit biotech organization, from the fall of 2020 to June 2022, and previously served as the organization’s Chief of Staff from January 2018 to the fall of 2020. Prior to that, she held senior leadership positions at Dimension Therapeutics, Inc., a gene therapy company, including Chief Operating Officer from 2016 to 2017 and Chief Business Officer from 2015 to 2016. Prior to joining Dimension Therapeutics, Inc., she spent six years at Cubist Pharmaceuticals, Inc., a biopharmaceutical company, where she held various leadership positions, including Senior Vice President, Business Development from 2014 to 2015, Vice President, Business Development from 2012 to 2013 and Senior Director, Business Development from 2009 to 2012. Prior to that, she held various positions at ViaCell, Inc. and PerkinElmer Inc. Ms. Thistle has served on the board of directors of Alaunos Therapeutics, Inc., formerly known as Ziopharm Oncology, Inc. since November 2020, Entrada Therapeutics, Inc. since May 2021 and Vigil

 

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Neuroscience, Inc. since April 2022. Ms. Thistle holds a B.S. in Business and Accounting from the University of Massachusetts, Boston and is a former Certified Public Accountant. Ms. Thistle is qualified to serve on the combined company’s board of directors due to her finance and business development background and industry experience.

Election of Officers

Q32’s executive officers are appointed by, and serve at the discretion of, Q32’s board of directors. There are no family relationships among any of Q32’s directors or executive officers.

Board of Directors of the Combined Company Following the Merger

Homology’s board of directors currently consists of eight directors divided into three staggered classes, with one class to be elected at each annual meeting to serve for a three-year term. The classified structure of the combined company board of directors will remain in place for the combined company following the completion of the Merger. It is anticipated that the incoming directors will be appointed to applicable vacant director seats of the combined company board of directors.

There are no family relationships among any of the proposed combined company directors and officers.

Committees of the Combined Company’s Board of Directors

In connection with the completion of the Merger, the standing committees of the board of directors of the combined company will continue to be the following: audit committee, compensation committee and a nominating and corporate governance committee, and each will continue to operate pursuant to a charter, which is expected to be amended and restated by the combined company’s board of directors in connection with the completion of the Merger. The combined company’s board of directors may establish other committees from time to time to assist it and its board of directors.

Audit Committee

The combined company’s audit committee will oversee its corporate accounting and financial reporting process. Among other matters, the audit committee’s responsibilities will include:

 

  •  

appointing, approving the compensation of, and assessing the independence of, the combined company’s independent registered public accounting firm;

 

  •  

overseeing the work of the combined company’s independent registered public accounting firm, including through the receipt and consideration of reports from such firm;

 

  •  

reviewing and discussing with management and the independent registered public accounting firm the combined company’s annual and quarterly financial statements and related disclosures;

 

  •  

monitoring the combined company’s internal control over financial reporting, disclosure controls and procedures and code of business conduct and ethics;

 

  •  

discussing the combined company’s risk management policies;

 

  •  

establishing policies regarding hiring employees from the independent registered public accounting firm and procedures for the receipt and retention of accounting-related complaints and concerns;

 

  •  

meeting independently with the combined company’s internal auditing staff, if any, independent registered public accounting firm and management;

 

  •  

reviewing and approving or ratifying any related person transactions; and

 

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  •  

preparing the audit committee report required by SEC rules to be included in the combined company’s annual proxy statement;

Following the consummation of the Merger, the members of the audit committee are expected to be                ,                and                .                is expected to be the chair of the audit committee and is a financial expert under the rules of the SEC. To qualify as independent to serve on the combined company’s audit committee, listing standards of Nasdaq and the applicable SEC rules require that a director not accept any consulting, advisory or other compensatory fee from the combined company, other than for service as a director, or be an affiliated person of the combined company. Homology and Q32 believe that, following the completion of the Merger, the composition of the audit committee will comply with the applicable requirements of the rules and regulations of Nasdaq and the SEC.

Compensation Committee

The combined company’s compensation committee will oversee policies relating to compensation and benefits of its officers and employees. Among other matters, the compensation committee’s responsibilities include:

 

  •  

reviewing and approving, or recommending for approval by the combined company’s board of directors, the compensation of the combined company’s CEO and its other executive officers;

 

  •  

overseeing and administering the combined company’s cash and equity incentive plans;

 

  •  

reviewing and making recommendations to the combined company’s board of directors with respect to director compensation;

 

  •  

periodically evaluating the combined company’s succession plans for the CEO and other executive officers;

 

  •  

overseeing and periodically reviewing matters related to the combined company’s human capital management as well as the combined company’s human key capital policies and practices, including with respect to diversity, equity and inclusion, workplace culture, and equitable pay practices;

 

  •  

reviewing and discussing annually with management the combined company’s “Compensation Discussion and Analysis,” to the extent required; and

 

  •  

preparing the annual compensation committee report, to the extent required by SEC rules.

Following the consummation of the Merger, the members of the compensation committee are expected to be                    ,                and                .                is expected to be the chair of the compensation committee. Each member of the combined company’s compensation committee is expected to be a “non-employee” director within the meaning of Rule 16b-3 of the rules promulgated under the Exchange Act and independent within the meaning of the independent director guidelines of Nasdaq. Homology and Q32 believe that, following the completion of the Merger, the composition of the compensation committee will comply with the applicable requirements of the rules and regulations of Nasdaq.

Nominating and Corporate Governance Committee

The nominating and corporate governance committee’s responsibilities will include:

 

  •  

identifying individuals qualified to become board members;

 

  •  

recommending to the combined company’s board of directors the persons to be nominated for election as directors and to each board committee;

 

  •  

reviewing the combined company’s board of director’s leadership structure;

 

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  •  

developing and recommending to the combined company’s board of directors corporate governance guidelines;

 

  •  

overseeing the combined company’s policies, programs and strategies related to environmental, social and governance matters (except with respect to human capital management matters that pertain to the authority and/or responsibilities of the combined company’s compensation committee); and

 

  •  

overseeing an annual evaluation of the board of directors.

Following the consummation of the Merger, the members of the nominating and corporate governance committee are expected to be                ,                 , and                 .                is expected be the chair of the nominating and corporate governance committee. Homology and Q32 believe that, after the completion of the Merger, the composition of the nominating and corporate governance committee will meet the requirements for independence under, and the functioning of such nominating and corporate governance committee will comply with, any applicable requirements of the rules and regulations of Nasdaq.

Compensation Committee Interlocks and Insider Participation

Each member of the compensation committee will be a “non-employee” director within the meaning of Rule 16b-3 of the rules promulgated under the Exchange Act and independent within the meaning of the independent director guidelines of Nasdaq. None of the proposed combined company’s executive officers serves as a member of the board of directors or compensation committee of any entity that has one or more executive officers who is proposed to serve on the combined company’s board of directors or compensation committee following the completion of the Merger.

Non-Employee Director Compensation

Prior to the Merger, Q32 did not have a formal policy to provide any cash or equity compensation to its non-employee directors for their service on its board of directors or committees of its board of directors, nor did any non-employee director receive any compensation for serving on Q32’s board of directors, except for Mark Iwicki who received an annual payment of $50,000, and Kathy LaPorte and Bill Lundberg, who each received an annual payment of $40,000.

In connection with closing of the Merger, it is expected that the combined company will provide compensation to non-employee directors pursuant to a new non-employee director compensation policy that is expected to be adopted post-closing.

 

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SELECTED HISTORICAL CONSOLIDATED FINANCIAL DATA

Selected Historical Consolidated Financial Data of Homology

The following tables summarize Homology’s consolidated financial data. The consolidated statement of operations data for the years ended December 31, 2022 and 2021 and the consolidated balance sheet data as of December 31, 2022 and 2021 have been derived from the audited consolidated financial statements included elsewhere in this proxy statement/prospectus. The consolidated statement of operations data for the nine months ended September 30, 2023 and 2022 and the consolidated balance sheet data as of September 30, 2023 have been derived from the unaudited condensed consolidated financial statements included elsewhere in this proxy statement/prospectus. You should read the following selected consolidated financial data together with “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and Homology’s financial statements and the related notes included elsewhere in this proxy statement/prospectus. Homology’s historical results are not necessarily indicative of results that should be expected in any future period and Homology’s results for the interim period are not necessarily indicative of the results that should be expected for the full year ending December 31, 2023.

 

     Nine-Months
Ended

September 30,
    Year Ended
December 31,
 
     2023     2022     2022     2021  
     (in thousands, except share and per share data)  

Collaboration revenue

   $ 1,156     $ 2,406     $ 3,208     $ 33,971  

Operating expenses:

        

Research and development

     60,489       71,202       98,351       93,085  

General and administrative

     23,355       29,991       38,138       36,835  

Restructuring and other charges

     6,640       —         —         —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     90,484       101,193       136,489       129,920  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (89,328 )      (98,787 )      (133,281 )      (95,949 ) 
  

 

 

   

 

 

   

 

 

   

 

 

 

Gain on sale of business

     —         131,249       131,249       —    

Interest income

     4,403       1,775       3,230       185  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other income

     4,403       133,024       134,479       185  
  

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) before income taxes

     (84,925 )      34,237       1,198       (95,764 ) 
  

 

 

   

 

 

   

 

 

   

 

 

 

Provision for income taxes

     —         (816 )      (715 )      —    

Loss from equity method investment

     (11,917 )      (4,131 )      (5,488 )      —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

   $ (96,842 )    $ 29,290     $ (5,005 )    $ (95,764 ) 
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)per share—basic

   $ (1.68 )    $ 0.51     $ (0.09 )    $ (1.73 ) 
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)per share—diluted

   $ (1.68 )    $ 0.51     $ (0.09 )    $ (1.73 ) 
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average common shares outstanding—basic

     57,788,755       57,372,399       57,399,762       55,283,318  

Weighted-average common shares outstanding—diluted

     57,788,755       57,901,298       57,399,762       55,283,318  

 

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     As of
September 30
     As of
December 31,
 
     2023      2022      2021  
     (in thousands)  

Consolidated Balance Sheet Data:

        

Cash and cash equivalents

   $ 29,111      $ 33,986      $ 108,382  

Short-term investments

     74,187        141,040        47,491  

Assets held for sale

     314        —          28,907  

Working capital (1)

     81,343        158,439        174,683  

Total assets

     140,063        228,470        211,721  

Total liabilities

     51,852        50,492        42,070  

Accumulated deficit

     (525,979 )       (429,137 )       (424,132 ) 

Stockholders’ equity

   $ 88,211      $ 177,978      $ 169,651  

 

  (1)

Working capital is defined as current assets less current liabilities

Selected Historical Consolidated Financial Data of Q32

The following tables summarize Q32’s consolidated financial data. The consolidated statement of operations data for the years ended December 31, 2022 and 2021 and the consolidated balance sheet data as of December 31, 2022 and 2021 have been derived from Q32’s audited consolidated financial statements included elsewhere in this proxy statement/prospectus. The consolidated statement of operations data for the nine months ended September 30, 2023 and 2022 and the consolidated balance sheet data as of September 30, 2023 have been derived from Q32’s unaudited condensed consolidated financial statements included elsewhere in this proxy statement/prospectus. You should read the following selected consolidated financial data together with “Q32 Management’s Discussion and Analysis of Financial Condition and Results of Operations” and Q32’s consolidated financial statements and the related notes included elsewhere in this proxy statement/prospectus. Q32’s historical results are not necessarily indicative of results that should be expected in any future period and Q32’s results for the interim period are not necessarily indicative of the results that should be expected for the full year ending December 31, 2023.

 

     Nine Months
Ended
September 30,
    Year Ended
December 31,
 
     2023     2022     2022     2021  
     (in thousands, except share and per share data)  

Collaboration arrangement revenue

   $ 8,011     $ 2,871     $ 6,651     $ —    

Operating expenses:

        

Research and development

     23,390       26,624       35,814       29,929  

General and administrative

     7,067       7,561       10,062       6,764  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     30,457       34,185       45,876       36,693  

Loss from operations

     (22,446 )      (31,314 )      (39,225 )      (36,693 ) 

Change in fair value of convertible notes

     (4,992 )      (997 )      (2,402 )      —    

Other income (expense), net

     827       (765 )      (1,120 )      (324 ) 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other income (expense), net

     (4,165 )      (1,762 )      (3,522 )      (324 ) 
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before provision for income taxes

     (26,611 )      (33,076 )      (42,747 )      (37,017 ) 

Provision for income taxes

     (65 )      (45 )      (62 )      (547 ) 
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss and comprehensive loss

     (26,676 )      (33,121 )      (42,809 )      (37,564 ) 
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss attributable to common stockholders—basic and diluted

   $ (3.70 )    $ (4.74 )    $ (6.09 )    $ (5.81 ) 
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average common shares—basic and diluted

     7,217,158       6,987,071       7,025,420       6,470,930  

 

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     As of
September 30
     As of
December 31,
 
     2023      2022      2021  
     (in thousands)  

Consolidated Balance Sheet Data:

        

Cash and cash equivalents

   $ 36,256      $ 43,893      $ 32,247  

Working capital (1)

     (32,737 )       (11,012 )       26,782  

Total assets

     53,769        61,774        35,151  

Total liabilities

     98,775        81,041        12,916  

Convertible preferred stock

     111,445        111,445        111,445  

Accumulated deficit

     (160,014 )       (133,338 )       (90,529 ) 

Stockholders’ deficit

   $ (156,451 )     $ (130,712 )     $ (89,210 ) 

 

  (1)

Working capital is defined as current assets less current liabilities

 

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SUMMARY OF UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL DATA

Selected Unaudited Pro Forma Condensed Combined Financial Data of Homology and Q32

The following unaudited pro forma condensed combined financial information was prepared based on the expectation that the Merger will be treated as a reverse recapitalization in accordance with U.S. generally accepted accounting principles, or GAAP. For accounting purposes, Q32 is considered to be completing an equity financing through the acquisition of Homology in the Merger. This determination is based on the expectations that, immediately following the Merger: (i) Q32’s equity holders will own a substantial majority of the voting rights in the combined organization, (ii) Q32 will designate a majority (seven of nine) of the initial board of directors of the combined organization, (iii) Q32’s senior management will hold all positions in the senior management of the combined organization and no employees from Homology will be retained and (iv) Homology primarily holds non-operating assets and the purpose of the transaction was to obtain additional capital to fund the operations of Q32.

Accordingly, for accounting purposes: (i) the Merger will be treated as the equivalent of Q32 issuing stock to acquire primarily cash and cash equivalents, short-term investments, and other non-operating assets, (ii) the net assets of Homology will be recorded based upon the fair values in the financial statements at the time of closing, which are primarily comprised of cash, cash equivalents, short-term investments and other non-operating assets and therefore expected to approximate the historical carrying value of the assets and (iii) the reported historical operating results of the combined company prior to the Merger will be those of Q32.

The unaudited pro forma condensed combined balance sheet assumes that Q32’s Pre-Closing Financing and the Merger were consummated as of September 30, 2023 and combines the historical balance sheets of Homology and Q32 as of such date. The unaudited pro forma condensed combined statement of operations for the year ended December 31, 2022 and the nine months ended September 30, 2023 assumes that Q32’s pre-closing financing and the merger were consummated as of January 1, 2022 and combines the historical results of Homology and Q32 for the respective periods presented.

The selected unaudited pro forma condensed combined financial data are presented for illustrative purposes only and are not necessarily indicative of the combined financial position or results of operations of future periods or the results that actually would have been realized had the entities been a single entity during these periods. The selected unaudited pro forma condensed combined financial data for the year ended December 31, 2022 and as of and for the nine months ended September 30, 2023 are derived from the unaudited pro forma condensed combined financial information and should be read in conjunction with that information. For more information, please see the section entitled “Unaudited Pro Forma Condensed Combined Financial Information” in this proxy statement/ prospectus.

 

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Selected Unaudited Pro Forma Condensed Combined Statements of Operations Data

 

     Nine Months
Ended September 30,
2023
    Year Ended
December 31, 2022
 
     (in thousands, except share and per share data)  

Collaboration arrangement revenue

   $ 9,167     $ 9,859  

Research and development expense

     83,879       134,165  

General and administrative expense

     30,422       56,400  

Restructuring and other charges

     6,640       —    

Other income/(expense), net

     5,230       149,744  

Provision for income taxes

     (65 )      (777 ) 

Loss on equity method investment

     (11,917 )      (5,488 ) 
  

 

 

   

 

 

 

Loss from operations

     (118,526 )      (37,227  

Net loss attributable to common stockholders—basis and diluted

     (118,526 )      (37,227 ) 
  

 

 

   

 

 

 

Net loss per share attributable to common stockholders—basic and diluted

   $ (0.54 )    $ (0.17 ) 
  

 

 

   

 

 

 

Selected Unaudited Pro Forma Condensed Combined Balance Sheet Data

 

     As of
September 30,
2023
 

Consolidated Balance Sheet Data:

  

Cash and cash equivalents

   $ 107,367  

Short-term investments

     74,187  

Working capital, net

     108,060  

Total assets

     235,092  

Total liabilities

     146,704  

Accumulated deficit

     (144,435 ) 

Total stockholders’ deficit

   $ 88,388  

 

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UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION

The following unaudited pro forma condensed combined financial statements are based on the Q32 Bio Inc.’s historical consolidated financial statements and Homology Medicine Inc.’s historical consolidated financial statements as adjusted to give effect to the merger of the companies, accounted for as a reverse recapitalization, and to the issuance of shares in the Q32 Pre-Closing Financing. The unaudited pro forma condensed combined financial information does not give effect to the proposed Reverse Stock Split because the Reverse Stock Split is not final.

The Merger

On November 16, 2023, Q32 Bio Inc’s (“Q32”) entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”) with Homology, Inc. (“Homology”) and Kenobi Merger Sub, Inc. a wholly owned subsidiary of Homology (“Merger Sub”). Pursuant to the Merger Agreement and subject to the satisfaction or waiver of the conditions therein, Merger Sub will merge with and into Q32, with Q32 continuing as the surviving company and as a wholly owned subsidiary of Homology (the “Merger”). If the Merger is completed, the business of Q32 will continue as the business of the combined company. The Merger is intended to qualify for federal income tax purposes as a tax-free reorganization under the provisions of Section 368(a) of the Internal Revenue Code of 1986, as amended.

Subject to the terms and conditions of the Merger Agreement, at the effective time of the Merger (the “Effective Time”), each then outstanding share of Q32 common stock (including shares of common stock issued upon conversion of Q32 preferred stock, conversion of Q32 convertible notes and shares of Q32 common stock issued in the Q32 pre-closing financing (as defined below) will be converted into the right to receive a number of shares of Homology’s common stock (ignoring rounding of fractional shares) calculated in accordance with the Merger Agreement (the “exchange ratio”).

At the Effective Time, Homology will assume outstanding and unexercised options to purchase shares of Q32 common stock, and in connection with the Merger they will be converted into options to purchase Homology Common Stock based on the exchange ratio formula in the Merger Agreement. At the Effective Time, Homology will assume outstanding and unexercised warrants to purchase shares of Q32 common stock, and in connection with the Merger they will be converted into warrants to purchase Homology common stock based on the exchange ratio formula in the Merger Agreement.

Immediately prior to the Effective Time, Q32 will cause the outstanding principal and accrued but unpaid interest on the Q32 convertible notes to be converted into shares of Q32 common stock. In addition, the Q32 preferred stock will be converted into Q32 common stock immediately prior to the Effective Time.

At the Effective Time, each person who, as of immediately prior to the Effective Time, was a stockholder of record of Homology or had the right to receive Homology’s common stock will be entitled to receive a contractual contingent value right (“CVR”) issued by Homology subject to and in accordance with the terms and conditions of a Contingent Value Rights Agreement between Homology, the holder’s representative and the rights agent (the “CVR Agreement”), representing the contractual right to receive consideration from the post-closing combined company upon the receipt of certain proceeds from a disposition of Homology’s pre-merger assets, calculated in accordance with the CVR Agreement. The unaudited pro forma condensed combined balance sheet includes $14.3 million of contingent consideration with respect to the CVRs.

The Merger is expected to be treated as a reverse recapitalization in accordance with GAAP because on the effective date of the Merger, the pre-combination assets of Homology are expected to be primarily cash and cash equivalents, short-term investments and other non-operating assets. Any in-process research and development assets potentially remaining as of the combination would have de minimis value when compared to the cash, cash equivalents and short-term investments obtained through the Merger.

 

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Immediately after the consummation of the Merger, based on the estimated exchange ratio as described in this proxy statement/prospectus, Q32 securityholders would own approximately 75% of the Homology common stock as defined in the Merger Agreement, and Homology securityholders would own approximately 25% of the Homology common stock as defined in the Merger Agreement, after giving effect to the Q32 pre-closing financing, and subject to adjustment of the exchange ratio as set forth in the Merger Agreement. Under certain circumstances further described in the Merger Agreement, the ownership percentages are subject to adjustment to the extent that Homology’s net cash as of the closing, as defined in the Merger Agreement (“Net Cash”) is less than $59.5 million or greater than $60.5 million and to the extent there are any changes to the amount of the Q32 Pre-Closing Financing (as defined below).

The percentage ownership of the combined company was derived using a stipulated value of Q32 of approximately $237.0 million, inclusive of the Q32 Pre-Closing Financing, and a stipulated value of Homology of approximately $80.0 million. The valuation of Homology was determined based on a projected net cash as defined in the Merger Agreement, of approximately $60.0 million at a determination date prior to the closing of the Merger, but subject to adjustment, plus an additional $20.0 million of equity value. The value from any future monetization of Homology operating assets, including fixed assets, intellectual property, and the equity method investment, will be delivered to the historical Homology equity holders via a cash dividend as stipulated in the CVR. The fair value of consideration transferred is not indicative of the combined entities’ enterprise value upon consummation of the Merger.

Because, among other things, the number of shares of Homology common stock issuable to Q32’s securityholders is determined based on Homology’s net cash balance on the business day prior to the anticipated closing date of the merger, Q32 securityholders cannot be certain of the exact number of shares that will be issued to (or reserved for issuance to) Q32 stockholders. The assumed exchange ratio referenced above is an estimate only and the final exchange ratio will be determined pursuant to a formula described in detail in the Merger Agreement included elsewhere in this proxy statement/prospectus.

The Q32 Pre-Closing Financing

In connection with the Merger Agreement, certain investors have entered into a subscription agreement with Q32 to purchase shares of Q32 common stock for an aggregate purchase price of approximately $42.0 million (the “Q32 Pre-Closing Financing”). The Q32 Pre-Closing Financing is contingent on and will occur prior to the closing of the merger, subject to customary closing conditions. Shares of the Q32 common stock issued pursuant to the Q32 Pre Closing Financing will be converted into shares of Homology common stock in accordance with the exchange ratio at the Effective Time.

The unaudited pro forma condensed combined balance sheet assumes that the Q32 Pre-Closing Financing, and the Merger were consummated as of September 30, 2023 and combines the historical balance sheets of Homology and Q32 as of such date. The unaudited pro forma condensed combined statement of operations for the year ended December 31, 2022 and the nine months ended September 30, 2023 assumes that the Q32 Pre-Closing Financing and the Merger were consummated as of January 1, 2022 and combines the historical results of Homology and Q32 for the respective periods presented.

The selected unaudited pro forma condensed combined financial data are presented for illustrative purposes only and are not necessarily indicative of the combined financial position or results of operations of future periods or the results that actually would have been realized had the entities been a single entity during these periods.

The unaudited pro forma condensed combined financial information is based on the assumptions and adjustments that are described in the accompanying notes. The accounting for the Merger requires the final calculation of Homology’s net cash. Accordingly, the pro forma adjustments are preliminary, subject to further revision as additional information becomes available and additional analyses are performed and have been made

 

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solely for the purpose of providing unaudited pro forma condensed combined financial information. Differences between these preliminary estimates and the final accounting, expected to be completed after the closing, will occur and these differences could have a material impact on the accompanying unaudited pro forma condensed combined financial information and the combined organization’s future results of operations and financial position.

The unaudited pro forma condensed combined financial information does not give effect to the potential impact of current financial conditions, regulatory matters, operating efficiencies or other savings or expenses that may be associated with the integration of the two companies. The unaudited pro forma condensed combined financial information is not necessarily indicative of the financial position or results of operations in future periods or the results that actually would have been realized had Homology and Q32 been a combined organization during the specified periods. The actual results reported in periods following the merger may differ significantly from those reflected in the unaudited pro forma condensed combined financial information presented herein for a number of reasons, including, but not limited to, differences in the assumptions used to prepare this pro forma financial information.

The unaudited pro forma condensed combined financial information, including the notes thereto, should be read in combination with the separate historical financial statements of Homology and Q32, and each company’s respective Management’s Discussion and Analysis of Financial Condition and Results of Operations included elsewhere in this proxy statement/prospectus.

Accounting rules require evaluation of certain assumptions, estimates, or determination of financial statement classifications. The accounting policies of Homology may materially vary from those of Q32. During preparation of the unaudited pro forma condensed combined financial information, management has performed a preliminary analysis and is not aware of any material differences, and accordingly, this unaudited pro forma condensed combined financial information assumes no material differences in accounting policies. Following the closing, management will conduct a final review of Homology’s accounting policies in order to determine if differences in accounting policies require adjustment or reclassification of Homology’s results of operations or reclassification of assets or liabilities to conform to Q32’s accounting policies and classifications. As a result of this review, management may identify differences that, when conformed, could have a material impact on these unaudited pro forma condensed combined financial statements.

 

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Unaudited Pro Forma Condensed Combined Balance Sheet

September 30, 2023

(in thousands)

 

    Q32     Homology     Q32
Pre-closing
Financing
Adjustments
    Pro Forma
Merger
Adjustments
   

Notes

(See Note 4)

  Pro
Forma
Combined
 

Assets

           

Current assets:

           

Cash and cash equivalents

  $ 36,256     $ 29,111     $ 42,000     $ —       A   $ 107,367  

Short-term investments

    —         74,187       —         —           74,187  

Assets held for sale

    —         314       —         —           314  

Prepaid expenses and other current assets

    2,845       3,023       —         (740 )    G     5,128  
 

 

 

   

 

 

   

 

 

   

 

 

     

 

 

 

Total current assets

    39,101       106,635       42,000       (740 )        186,996  
 

 

 

   

 

 

   

 

 

   

 

 

     

 

 

 

Restricted cash

    5,647       —         —         —           5,647  

Equity method investment

    —         13,957       —         —           13,957  

Property and equipment, net

    1,906       —         —         —           1,906  

Right-of-use asset, operating leases

    6,438       19,471       —         —           25,909  

Other non-current assets

    677       —         —         —           677  
 

 

 

   

 

 

   

 

 

   

 

 

     

 

 

 

Total assets

  $ 53,769     $ 140,063     $ 42,000     $ (740 )      $ 235,092  
 

 

 

   

 

 

   

 

 

   

 

 

     

 

 

 

Liabilities, Convertible Preferred Stock and Stockholders’ Deficit

           

Current liabilities:

           

Accounts payable

  $ 1,829     $ 7,803     $ —       $ —         $ 9,632  

Accrued expenses and other current liabilities

    7,399       15,711       —         19,200     D, E, F,G     42,310  

Convertible notes

    37,394       —         —         (37,394 )    B     —    

Venture debt, current portion

    418       —         —         —           418  

Operating lease liabilities, current portion

    —         1,778       —         —           1,778  

Deferred revenue, current portion

    24,798       —         —         —           24,798  
 

 

 

   

 

 

   

 

 

   

 

 

     

 

 

 

Total current liabilities

    71,838       25,292       —         (18,194 )        78,936  

Deferred revenue, net of current portion

    15,540       —         —         —           15,540  

Operating lease liabilities, net of current portion

    6,386       26,560       —         —           32,946  

CVR derivative liability

    —         —         —         14,271     H     14,271  

Venture debt

    5,011       —         —         —           5,011  
 

 

 

   

 

 

   

 

 

   

 

 

     

 

 

 

Total liabilities

    98,775       51,852         (3,923 )        146,704  

Series A convertible preferred stock

    47,458       —         —         (47,458 )    C     —    

Series A-1 convertible preferred stock

    4,132       —         —         (4,132 )    C     —    

Series B convertible preferred stock

    59,855       —         —         (59,855 )    C     —    
 

 

 

   

 

 

   

 

 

   

 

 

     

 

 

 

Total convertible preferred stock

    111,445       —         —         (111,445 )        —    
 

 

 

   

 

 

   

 

 

   

 

 

     

 

 

 

Stockholders’ deficit:

           

Preferred stock

    —         —         —         —           —    

Common stock

    1       6       4       12     K     23  

Additional paid-in-capital

    3,562       614,220       41,996       (426,978 )    K     232,800  

Accumulated other comprehensive loss

    —         (36 )      —         36     K     —    

Accumulated deficit

    (160,014 )      (525,979 )      —         541,558     K     (144,435 ) 
 

 

 

   

 

 

   

 

 

   

 

 

     

 

 

 

Total stockholders’ deficit

    (156,451 )      88,211       42,000       114,628         88,388  
 

 

 

   

 

 

   

 

 

   

 

 

     

 

 

 

Total liabilities, convertible preferred stock and stockholders’ deficit

  $ 53,769     $ 140,063     $ 42,000     $ (740 )      $ 235,092  
 

 

 

   

 

 

   

 

 

   

 

 

     

 

 

 

The accompanying notes are an integral part of this pro forma condensed financial information.

 

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Unaudited Pro Forma Condensed Combined Statement of Operations

For the Nine Months Ended September 30, 2023

(in thousands, except share and per share amounts)

 

    Q32     Homology     Q32
Pre-closing
Financing
Adjustments
    Pro Forma
Merger
Adjustments
    Notes   Pro Forma
Combined
 

Collaboration arrangement revenue

  $ 8,011     $ 1,156     $ —       $ —         $ 9,167  

Operating expense:

           

Research and development

    23,390       60,489       —         —           83,879  

General and administrative

    7,067       23,355       —         —           30,422  

Restructuring and other charges

    —         6,640       —         —           6,640  
 

 

 

   

 

 

   

 

 

   

 

 

     

 

 

 

Total operating expense

    30,457       90,484       —         —           120,941  
 

 

 

   

 

 

   

 

 

   

 

 

     

 

 

 

Loss from operations

    (22,446 )      (89,328 )      —         —           (111,774 ) 

Change in fair value of convertible notes

    (4,992 )      —         —         4,992     J     —    

Other income (expense), net

    827       4,403       —         —           5,230  
 

 

 

   

 

 

   

 

 

   

 

 

     

 

 

 

Total other income (expense), net

    (4,165 )      4,403       —         4,992         5,230  
 

 

 

   

 

 

   

 

 

   

 

 

     

 

 

 

Loss before provision for income taxes

    (26,611 )      (84,925 )      —         4,992         (106,544 ) 

Provision for income taxes

    (65 )      —         —         —           (65 ) 

Loss from equity method investment

    —         (11,917 )      —         —           (11,917 ) 
 

 

 

   

 

 

   

 

 

   

 

 

     

 

 

 

Net loss and comprehensive loss

  $ (26,676 )    $ (96,842 )    $ —       $ 4,992       $ (118,526 ) 
 

 

 

   

 

 

   

 

 

   

 

 

     

 

 

 

Net loss attributable to common stockholders’—basic and diluted

  $ (3.70 )    $ (1.68 )        L   $ (0.54 ) 
 

 

 

   

 

 

         

 

 

 

Weighted-average common shares—basic and diluted

    7,217,158       57,788,755         L     217,509,492  
 

 

 

   

 

 

         

 

 

 

The accompanying notes are an integral part of this pro forma condensed financial information.

 

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Unaudited Pro Forma Condensed Combined Statement of Operations

For the Year Ended December 31, 2022

(in thousands, except share and per share amounts)

 

    Q32     Homology     Q32
Pre-closing
Financing
Adjustments
    Pro Forma
Merger
Adjustments
    Notes   Pro Forma
Combined
 

Collaboration arrangement revenue

  $ 6,651     $ 3,208     $ —       $ —         $ 9,859  

Operating expense:

           

Research and development

    35,814       98,351       —         —           134,165  

General and administrative

    10,062       38,138       —         8,200     F, G     56,400  
 

 

 

   

 

 

   

 

 

   

 

 

     

 

 

 

Total operating expense

    45,876       136,489       —         8,200         190,565  
 

 

 

   

 

 

   

 

 

   

 

 

     

 

 

 

Loss from operations

    (39,225 )      (133,281 )      —         (8,200 )        (180,706 ) 

Other income (expense), net

           

Gain on sale of business

    —         131,249       —         —           131,249  

Change in fair value of convertible notes

    (2,402 )      —         —         (4,992 )    J     (7,394 ) 

Gain on conversion of convertible notes

    —         —           23,779     B     23,779  

Other income (expense), net

    (1,120 )      3,230       —         —           2,110  
 

 

 

   

 

 

   

 

 

   

 

 

     

 

 

 

Total other income (expense), net

    (3,522 )      134,479       —         18,787         149,744  
 

 

 

   

 

 

   

 

 

   

 

 

     

 

 

 

Income (loss) before provision for income taxes

    (42,747 )      1,198       —         10,587         (30,962 ) 

Provision for income taxes

    (62 )      (715 )        —           (777 ) 

Loss from equity method investment

    —         (5,488 )      —         —           (5,488 ) 
 

 

 

   

 

 

   

 

 

   

 

 

     

 

 

 

Net loss and comprehensive loss

  $ (42,809 )    $ (5,005 )    $ —       $ 10,587       $ (37,227 ) 
 

 

 

   

 

 

   

 

 

   

 

 

     

 

 

 

Net loss attributable to common stockholders’—basic and diluted

  $ (6.09 )    $ (0.09 )        L   $ (0.17 ) 
 

 

 

   

 

 

         

 

 

 

Weighted-average common shares—basic and diluted

    7,025,420       57,399,762         L     217,326,236  
 

 

 

   

 

 

         

 

 

 

The accompanying notes are an integral part of this pro forma condensed financial information.

 

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Notes to the Unaudited Pro Forma Condensed Combined Financial Information

All amounts below are in thousands, unless specifically noted otherwise, except share and per share amounts.

1. Description of Transaction

Upon the Effective Time, all shares of Q32 common stock outstanding immediately prior to the Effective Time, after giving effect to the preferred stock conversion, convertible notes conversion, and the Q32 Pre-Closing Financing, will be converted into the right to receive approximately 158,642,164 shares of Homology’s common stock in the aggregate, based on an assumed exchange ratio of 0.88, which has not been adjusted to reflect the proposed Reverse Stock Split because the Reverse Stock Split is not final and is subject to certain adjustments, including Homology’s final Net Cash at closing. This exchange ratio is an estimate only and the final exchange ratio at closing will be determined pursuant to a formula described in more detail in the Merger Agreement.

Q32 estimates that the aggregate value of the consideration to be paid in the merger will be approximately $45.3 million. The fair value of consideration transferred is based on the number of common shares Homology stockholders will own of the combined company upon consummation of the merger, multiplied by the closing price or fair value of Homology common stock on November 30, 2023, the most recent practicable date prior to the filing of this registration statement, as well as the fair value of outstanding options to purchase Homology common stock and the fair value of the CVR. The number and value of the shares of Homology common stock and options to purchase Homology common stock to be held by Homology stockholders to be outstanding following the Merger and the fair value of the CVRs will not be determined until the completion of the Merger and therefore, the final aggregate value of the consideration paid in the Merger may be more or less than $45.3 million. The fair value of consideration transferred is not indicative of the combined entities enterprise value upon consummation of the Merger. As the Merger will be accounted for as a reverse recapitalization, any difference between the consideration to be transferred in the merger and the fair value of the net assets acquired will be recorded as an adjustment to additional paid-in capital.

Consummation of the merger is subject to certain closing conditions, including, among other things, approval by the Homology stockholders and the Q32 stockholders.

2. Basis of Pro Forma Presentation

The unaudited pro forma condensed combined financial information does not give effect to the proposed Reverse Stock Split because the Reverse Stock Split has not yet been determined.

The unaudited pro forma condensed combined financial information has been prepared in accordance with SEC Regulation S-X Article 11. The unaudited pro forma condensed combined statements of operations for the year ended December 31, 2022 and the nine months ended September 30, 2023, give effect to the Q32 Pre-Closing Financing and Merger as if they had been consummated on January 1, 2022. The unaudited pro forma condensed combined balance sheet as of September 30, 2023 gives effect to the Q32 Pre-Closing Financing and the Merger as if they had been consummated on September 30, 2023.

For accounting purposes, Q32 is considered to be the acquiring company and the Merger is expected to be accounted for as a reverse recapitalization of Q32 because on the Merger date, the pre-combination assets of Homology are expected to be primarily cash, cash equivalents, short-term investments and other non-operating assets.

 

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For purposes of these pro forma financial statements, the total estimated purchase price is summarized as follows (in thousands, except share and per share amounts):

 

Estimated number of shares of the combined company to be owned by Homology stockholders (i)

    58,017,412  

Multiplied by the assumed price per share of Homology stock (ii)

  $ 0.53  
 

 

 

 

Total

    30,749  

Estimated fair value of assumed Homology equity awards based on pre-combination service (iii)

    273  

Estimated fair value of the contingent value right (iv)

    14,271  
 

 

 

 

Total estimated purchase price

  $ 45,293  
 

 

 

 

 

  i.

Reflects the number of shares of common stock of the combined company that Homology equity holders would own as of the closing pursuant to the Merger Agreement. This amount is calculated, for purposes of this unaudited pro forma condensed combined financial information, based on shares of Homology common stock outstanding as of November 30, 2023. The estimated number of shares does not reflect the impact of the reverse stock split that is expected to be effective prior to consummation of the merger because the reverse stock split is not final.

  ii.

Reflects the price per share of Homology common stock, which is the closing trading price of Homology common stock outstanding as of November 30, 2023.

  iii.

The estimated purchase price includes the estimated acquisition-date fair value of the assumed Homology equity awards attributable to pre-combination service (which amount is determined based on the closing trading price of Homology common stock on November 30, 2023, the number of Homology equity awards outstanding on this date, and the period of service provided by the holders of the awards prior to the merger closing date). The following table presents on a weighted average basis, the assumptions used in the Black-Scholes option-pricing model to determine the estimated acquisition date fair value of the assumed Homology equity awards:

 

Expected term (in years)

     1  

Volatility

     64.18 % 

Risk free interest rate

     5.23 % 

Dividend yield

     —    

 

  iv.

The estimated fair value of the CVR is $14.3 million, which is the fair value of the estimated cash dividend expected to be paid.

The actual purchase consideration for the net assets of Homology will vary based on the Homology share price at closing and the fair value of the CVR; however, any difference between the consideration transferred and the fair value of the net assets of Homology following determination of the actual purchase consideration for Homology will be reflected as an adjustment to additional paid-in capital. The estimated purchase consideration reflected in these unaudited pro forma condensed combined financial information does not purport to represent what the actual purchase consideration will be when the Merger is completed. The actual purchase price will fluctuate until the Effective Time of the Merger.

Under reverse recapitalization accounting, the subsequent financial statements of Q32 will reflect the operations of the acquirer for accounting purposes together with a deemed issuance of shares, equivalent to the shares held by the former stockholders of the legal acquirer and a recapitalization of the equity of the accounting acquirer. The accompanying unaudited pro forma condensed combined financial information is derived from the historical financial statements of Homology and Q32, and include adjustments to give pro forma effect to reflect the accounting for the transaction in accordance with U.S. GAAP. The historical financial statements of Q32 will become the historical financial statements of the combined company.

Q32 and Homology may incur significant costs associated with integrating the operations of Q32 and Homology after the Merger is completed. The unaudited pro forma condensed combined financial information

 

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does not reflect the costs of any integration activities or benefits that may result from realization of future cost savings from operating efficiencies which may result from the Merger.

3. Shares of Homology Common Stock Issued to Q32 Stockholders upon Closing of the Merger

Prior to the Merger, all Convertible Notes and outstanding shares of Q32 convertible preferred stock are expected to convert into Q32 common stock, which will be exchanged for shares of Homology common stock based on the exchange ratio determined in accordance with the Merger Agreement. The estimated exchange ratio for purposes of the unaudited pro forma condensed combined financial information was derived using a stipulated value of Q32 of approximately $237.0 million (including the Q32 pre-closing financing disclosed above) and of Homology of approximately $80.0 million. The estimated number of shares of common stock that Homology expects to issue to Q32’s common stockholders, preferred stockholders and convertible note holders as of November 30, 2023 (ignoring rounding of fractional shares) is determined as follows:

 

Shares of Q32 common stock outstanding

     7,233,665  

Estimated shares of Q32’s common stock to be issued upon consummation of the Q32 Concurrent Financing

     35,032,111  

Shares of Q32 common stock to be issued upon conversion of Q32 preferred stock

     108,818,415  

Shares of Q32 common stock to be issued upon conversion of Q32 convertible notes

     29,190,995  
  

 

 

 

Total

     180,275,186  
  

 

 

 

Exchange ratio

     0.88  
  

 

 

 

Estimated shares of Homology common stock to be issued to Q32 shareholders upon closing of the Merger

     158,642,164  

The exchange ratio and estimated shares of Homology common stock issued to Q32’s securityholders have not been adjusted to give effect to the proposed Reverse Stock Split because the Reverse Stock Split is not final.

4. Pro Forma Adjustments

Adjustments included in the column under the heading “Q32 Pre-Closing Financing Adjustments” are primarily based on information contained within the subscription agreement for the Q32 Pre-Closing Financing and adjustments included in the column under the heading “Pro Forma Merger Adjustments” are primarily based on information contained within the Merger Agreement. Further analysis will be performed after the completion of the Merger to confirm these estimates.

Both Q32 and Homology have a history of generating net operating losses and maintain a full valuation allowance against their net deferred tax assets. For the year ended December 31, 2022, Homology recorded an income tax provision of $0.7 million. Q32 has recorded a tax provision of $65 thousand for the nine months ended September 30, 2023 and $62 thousand for the year ended December 31, 2022. Management of both entities have not identified any changes to the income tax positions due to the merger that would result in an incremental tax expense or benefit. Accordingly, no tax related adjustments have been reflected for the pro forma adjustments.

The pro forma adjustments, based on preliminary estimates that could change materially as additional information is obtained, are as follows:

A. The Q32 Pre-Closing Financing is contingent on the Merger and is expected to close immediately prior to the consummation of the Merger. The adjustment reflects cash proceeds of $42.0 million from the sale and issuance of 35,032,111 shares of Q32 common stock at a purchase price of $1.20 per share pursuant to the subscription agreement entered into in connection with the Q32 Pre-Closing Financing. The issuance of common stock related to this Pre-Closing Financing results in an increase of $4 thousand to common stock and an increase of $42.0 million to additional paid-in-capital in the unaudited pro forma condensed combined balance sheet. The potential use of proceeds from the Q32 pre-closing financing has not yet been

 

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finalized, and as a result, for the purposes of the unaudited pro forma condensed combined statement of operations, no adjustments were made to reflect interest income from the potential investment of the proceeds or any other use of proceeds from the Q32 pre-closing financing.

B. As a condition of the closing, Q32 is required to convert its outstanding convertible notes plus accrued interest into shares of common stock at 90% of the purchase price of the mandatory conversion event. For the purposes of the unaudited pro forma condensed combined statements of operations, Q32’s conversion of its convertible notes is reflected as if it occurred on January 1, 2022, resulting in the issuance of 29,190,995 shares of Q32 common stock. As the convertible notes are recorded at fair value, a gain of $23.8 million on conversion of convertible stock reflected in the unaudited pro forma condensed combined statement of operation for the year ended December 31, 2022. The conversion of the Q32 convertible notes into shares of Q32 common stock results in an increase of $1 thousand to Common stock and an increase of $13.6 million to additional paid-in-capital in the unaudited pro forma condensed combined balance sheet.

C. Immediately prior to completing the Merger, all classes of convertible preferred stock of Q32 will be converted to Q32 common stock. The Series A convertible preferred stock is expected to convert to 47,628,788 shares of Q32 common stock, the Series A-1 convertible preferred stock is expected convert to 6,500,000 shares of Q32 common stock and the Series B convertible preferred stock is expected to convert to 54,689,627 shares of Q32 common stock. The conversion of the Q32 preferred stock into shares of Q32 common stock results in an increase of $11 thousand to Common stock and an increase of $111.4 million to additional paid-in-capital in the unaudited pro forma condensed combined balance sheet.

D. To reflect Homology’s estimated transaction costs of $4.5 million that were not accrued as of September 30, 2023, consisting of legal and accounting related fees of approximately $2.0 million, and investment banking fees of approximately $2.5 million as an increase to accrued expenses and an increase to accumulated deficit of $4.5 million in the unaudited pro forma condensed combined balance sheet.

E. To reflect Q32’s estimated transaction costs of $6.5 million that were not accrued as of September 30, 2023, consisting of legal and accounting related fees of approximately $4.7 million and investment banking fees of approximately $1.8 million as an increase to accrued expenses and a reduction to additional paid-in capital of $6.5 million in the unaudited pro forma condensed combined balance sheet. As the merger will be accounted for as a reverse recapitalization equivalent to the issuance of equity for the primarily cash and cash equivalents, short-term investments, and other non-operating assets of Homology, these direct and incremental costs are treated as a reduction of the net proceeds received within additional paid-in capital. The adjustments for transaction costs exclude costs related to Q32’s ongoing operations as a public company, which will be charged to expense as incurred.

F. Estimated compensation expense of $6.1 million related to change-in-control cash payments, retention and severance payments resulting from pre-existing employment agreements that will be payable in cash in connection with the Merger but were not incurred as of September 30, 2023 is reflected as an increase to accrued expenses and accumulated deficit in the unaudited pro forma condensed combined balance sheet. Homology’s compensation costs of $6.1 million are reflected as general and administrative expense in the unaudited pro forma condensed combined statement of operations for the year ended December 31, 2022.

G. To remove Homology’s prepaid D&O Insurance policy of $0.8 million as a reduction to prepaid expenses and other current assets and accumulated deficit of $0.8 million in the unaudited pro forma condensed combined balance sheet, and replace it with a $2.1 million D&O tail policy as an increase to accrued expenses and accumulated deficit of $2.1 million in the unaudited pro forma condensed combined balance sheet. Homology’s D&O tail policy expense of $2.1 million is reflected as general and administrative expense in the unaudited pro forma condensed combined statement of operations for the year ended December 31, 2022.

H. The estimated fair value of the CVR is $14.3 million, which is the fair value of the estimated cash dividend expected to be paid.

I. Homology’s historical financial statements were adjusted to give pro forma effect to events in connection with the Merger that include the elimination of Homology’s historical common stock, additional paid-in

 

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capital and accumulated deficit balances and the capitalization of the fair value of the estimated number of common shares of the combined company to be owned by Homology stockholders.

J. To remove $5.0 million of change in fair value of convertible notes for the nine months ended September 30, 2023 and add it to the year ended December 31, 2022.

K. The impacts of the adjustments from the Merger for the Pre-Closing Financing and pro forma adjustments on the equity accounts are included in the table below.

The amounts of the elimination of Homology’s historical equity carrying values within the table above include the impacts of the pro forma adjustments related to pre-merger expenses of Homology. A reconciliation from the amounts of Homology’s historical equity carrying values contained within the unaudited pro forma condensed combined balance sheet as of September 30, 2023 is as follows:

 

    Common                                
    Q32     Homology                                

(amounts in thousands, except share
amounts)

  Shares     Amount     Shares     Amount     Additional
Paid-In-
Capital
    Accumulated
Deficit
    Accumulated
Other
Comprehensive
Loss
    Total
Shareholders’
Deficit
    Notes  

Q32 historical equity carrying values as of September 30, 2023

    7,233,665       1       —         —         3,562       (160,014 )      —         (156,451 )   

Homology historical equity carrying values as of September 30, 2023 (i)

    —         —         58,017,412       6       614,220       (525,979 )      (36 )      88,211    
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Combined historical equity carrying values as of September 30, 2023

    7,233,665       1       58,017,412       6       617,782       (685,993 )      (36 )      (68,240 )   

Effect of Consummation of Q32 pre-closing financing

    35,032,111       4       —         —         41,996       —         —         42,000       A  

Total Q32 Pre-closing Financing Adjustments

    35,032,111       4       —         —         41,996       —         —         42,000    
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Conversion of Q32 convertible notes into Q32 common stock

    29,190,995       1       —         —         13,613       23,779       —         37,393       B  

Conversion of outstanding Q32 convertible preferred stock into Q32 common stock

    108,818,415       11       —         —         111,434       —         —         111,445       C  

Stock-based compensation costs recognized by Homology related to acceleration of vesting of equity awards upon closing (ii)

    —         —         849,916       1       272       (273 )      —         —      

Derecognition of Homology prepaid item being written off (ii)

    —         —         —         —         —         (740 )      —         (740 )      G  

Homology transaction costs assoicated with the transaction

    —         —         —         —         —         (4,500 )      —         (4,500 )      D  

Elimination of Homology’s historical equity carrying values, after pro forma adjustments

    —         —         —         —         (531,528 )      531,492       36       —         I  

Issuance of CVR

    —         —         —         —         (14,271 )      —         —         (14,271 )      H  

Exchange of outstanding Q32’s common stock based on the assumed Exchange Ratio for purposes of these pro forma condensed combined financial statements

    (180,275,186 )      (17 )      158,642,164       16       1       —         —         —      

Payment of transaction costs associated with the merger

    —         —         —         —         (6,499 )      —         —         (6,499 )      E  

Payment of transaction related insurance costs

    —         —         —         —         —         (2,100 )      —         (2,100 )      G  

Payment of change-in-control, retention and severance in connection with the merger

    —         —         —         —         —         (6,100 )      —         (6,100 )      F  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total Pro Forma Merger Adjustments

    (42,265,776 )      (5 )      159,492,080       17       (426,978 )      541,558       36       114,628    
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Pro Forma Combined

    —         —         217,509,492       23       232,800       (144,435 )      —         88,388    
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

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(i)

Homology shares are as of November 30, 2023.

 

(ii)

Homology shares are as of November 30 2023. This adjustment reflects the acceleration of Homology share-based compensation and is treated as a precombination expense.

L. The pro forma combined basic and diluted earnings per share have been adjusted to reflect the pro forma net loss for the year ended December 31, 2022 and the nine months ended September 30, 2023. In addition, the weighted average shares outstanding for these periods have been adjusted to give effect to the issuance of Homology’s common stock in connection with the Q32 pre-closing financing and the merger as of November 30, 2023. As the combined organization is in a net loss position for both periods presented, any adjustment for potentially dilutive shares would be anti-dilutive, and as such basic and diluted loss per share are the same for both periods presented. The following table presents the calculation of the pro forma

 

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weighted average number of common stock outstanding. The estimated number of shares does not reflect the impact of the proposed Reverse Stock Split that is expected to be effected prior to consummation of the merger because the Reverse Stock Split is not final:

 

     Nine Months
Ended September 30,
2023
     Year Ended
December 31, 2022
 

Weighted-average Q32 common shares outstanding—basic and diluted

     7,233,665        7,025,420  

Impact of Q32 pre-closing financing assuming consummation as of January 1, 2022

     35,032,111        35,032,111  

Impact of Q32 convertible notes assuming conversion as of January 1, 2022

     29,190,995        29,190,995  

Impact of Q32 convertible preferred stock assuming conversion as of January 1, 2022

     108,818,415        108,818,415  
  

 

 

    

 

 

 

Total

     180,275,186        180,066,941  

Application of exchange ratio to historical Q32 weighted-average shares outstanding

     0.88        0.88  
  

 

 

    

 

 

 

Adjusted Q32 weighted-average shares outstanding

     158,642,164        158,458,908  

Impact of Homology common stock related to stock units that accelerated vesting as of January 1, 2022

     350,759        350,759  

Impact of common shares issued upon vesting of equity awards for the combined company as of January 1, 2022

     499,157        499,157  

Weighted-average Homology common shares outstanding—basic and diluted

     58,017,412        58,017,412  
  

 

 

    

 

 

 

Pro forma combined weighted-average number of shares of common stock—basic and diluted

     217,509,492        217,326,236  
  

 

 

    

 

 

 

 

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Q32 EXECUTIVE AND DIRECTOR COMPENSATION

2022 Director Compensation Table

The following table presents the total compensation for each person who served as a non-employee director of the Q32 board of directors during 2022. Ms. Morrison, Q32’s Chief Executive Officer and President, and Mr. Broxson, Q32’s former Chief Executive Officer, did not receive any additional compensation from Q32 for their services on Q32’s board of directors. The compensation received by each of Ms. Morrison and Mr. Broxson as a named executive officer, or NEO, is set forth below in “Executive Compensation—2022 Summary Compensation Table.”

 

Name

   Fees Paid
or Earned
in Cash ($)
     Total
($)
 

Jayson Punwami (1)

     —          —    

David Grayzel (2)

     —          —    

Mark Iwicki (3)

     50,000        50,000  

Kathy LaPorte (4)

     40,000        40,000  

Bill Lundberg (5)

     40,000        40,000  

Isaac Manke (6)

     —          —    

Diyong Xu (7)

     —          —    

 

(1)

As of December 31, 2022, Mr. Punwami did not hold any outstanding equity awards.

(2)

As of December 31, 2022, Mr. Grayzel did not hold any outstanding equity awards.

(3)

As of December 31, 2022, Mr. Iwicki held options to purchase 933,848 shares of Q32’s common stock.

(4)

As of December 31, 2022, Ms. LaPorte held options to purchase 153,690 shares of Q32’s common stock and holds 113,124 shares of common stock.

(5)

As of December 31, 2022, Mr. Lundberg held options to purchase 231,875 shares of Q32’s common stock and holds 25,000 shares of common stock.

(6)

As of December 31, 2022, Mr. Manke did not hold any outstanding equity awards.

(7)

As of December 31, 2022, Mr. Xu did not hold any outstanding equity awards.

Narrative to 2022 Director Compensation Table

Q32 does not currently have a formal non-employee director compensation program but has entered into letter agreements with certain of its independent, non-employee directors that provide for quarterly payments of $10,000 for Ms. LaPorte and Mr. Lundberg and $12,500 for Mr. Iwicki. No non-employee director received any equity grants in 2022.

Executive Compensation Prior to the Merger

Unless the context otherwise requires, any reference in this section of this proxy statement/prospectus to “Q32” refers to Q32 and its consolidated subsidiaries prior to the consummation of the Merger and to Q32 and its consolidated subsidiaries following the Merger. As an emerging growth company, Q32 has opted to comply with the executive compensation disclosure rules applicable to “smaller reporting companies” as such term is defined in the rules promulgated under the Securities Act, which require compensation disclosure for its principal executive officer and its two other most highly compensated executive officers.

This section discusses the material components of the executive compensation program offered to the executive officers of Q32 who would have been “named executive officers” for 2022 and who will serve as the executive officers of the combined company following the consummation of the Merger, other than Michael Broxson, who separated from Q32 on September 30, 2022, and Adam Cutler, who resigned as Q32’s Chief

 

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Financial Officer in October 2023. Such executive officers consist of the following persons, referred to herein as our NEOs:

 

  •  

Jodie Morrison, Q32’s Chief Executive Officer and President;

 

  •  

Michael Broxson, Q32’s former Chief Executive Officer;

 

  •  

Jason Campagna, Q32’s Chief Medical Officer; and

 

  •  

Adam Cutler, Q32’s former Chief Financial Officer.

Each of our NEOs will serve us in the same capacities after the consummation of the Merger, other than Michael Broxson, who separated from Q32 on September 30, 2022, and Adam Cutler, who resigned as Q32’s Chief Financial Officer in October 2023.

This discussion may contain forward-looking statements that are based on Q32’s current plans, considerations, expectations and determinations regarding future compensation programs. Actual compensation programs that Q32 adopts following the consummation of the Merger could vary significantly from Q32’s historical practices and currently planned programs summarized in this discussion.

2022 Summary Compensation Table

The following table presents information regarding the total compensation awarded to, earned by and paid to Q32’s NEOs for services during the fiscal year ended December 31, 2022.

 

Name and Principal Position

  Year     Salary
($)(1)
    Bonus
($)(2)
    Option Awards
($)(3)
    All Other
Compensation
($)
    Total
($)
 

Jodie Morrison (4)

Chief Executive Officer & President

    2022       120,353       100,000       1,667,171       150       1,887,674  

Michael Broxson (5)

Former Chief Executive Officer

    2022       364,237       —         182,420 (6)      454,450 (7)      1,001,107  

Jason Campagna

Chief Medical Officer

    2022       442,000       176,800       —         600       619,400  

Adam Cutler (8)

Former Chief Financial Officer

    2022       430,000       142,975       —         600       573,575  

 

(1)

The amounts in this column represent the total base salaries earned in fiscal year 2022.

(2)

Amounts in this column represent discretionary annual bonuses earned for performance in fiscal year 2022, which were paid in early 2023. For more information regarding the annual bonuses, see “—Narrative Disclosure to Summary Compensation Table—Annual Bonuses” below.

(3)

The amounts reported represent the aggregate grant date fair value of the stock option awards granted to our named executive officers during 2022, calculated in accordance with FASB ASC Topic 718. Such grant date fair values do not take into account any estimated forfeitures. The assumptions used in calculating the grant date fair value of the stock option awards reported in this column are set forth in note 10 of Q32’s audited financial statements included elsewhere in this proxy statement/prospectus. The amounts reported in this column reflect the accounting cost for these stock option awards and do not correspond to the actual economic value that may be received by Q32’s named executive officers upon the exercise of the stock option awards or any sale of the underlying shares of Q32 common stock.

(4)

Ms. Morrison commenced part-time employment with Q32 on September 8, 2022 and became a full-time employee on November 1, 2022.

(5)

Mr. Broxson separated from Q32 on September 30, 2022. His base salary represents amounts paid up until his termination date.

 

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(6)

This amount reflects the incremental fair value of the portion of Mr. Broxson’s options that accelerated vesting and the extension of his post-termination exercise period, which Mr. Broxson received in connection with his termination, as calculated in accordance with FASB ASC Topic 718.

(7)

The amount reported represents a wellness payment in the amount of $450 and severance payments in connection with his termination in the amount of $446,706 in base salary continuation and $7,294 in COBRA continuation.

(8)

Mr. Cutler resigned as Q32’s Chief Financial Officer in October 2023.

Narrative Disclosure to the 2022 Summary Compensation Table

2022 Base Salaries

Each NEO’s base salary is a fixed component of annual compensation for performing specific duties and functions. Base salaries are adjusted from time to time to realign salaries with market levels after taking into account individual responsibilities, performance and experience. For the fiscal year ended December 31, 2022, the base salaries for Ms. Morrison and Mr. Broxson, Campagna and Cutler were $500,000 (increased from $250,000 when Ms. Morrison became a full-time employee on November 1, 2022), $446,706, $442,000, and $430,000, respectively.

2022 Annual Bonuses

Each NEO is eligible to earn an annual incentive bonus for each year they are employed by Q32, with the target amount of such bonus opportunity set as a percentage of each NEO’s annual base salary and based on achievement of certain corporate goals. The actual bonus amounts were determined by Q32’s Chief Executive Officer (except with respect to her own bonus) and its board of directors, in their absolute discretion. For the year ended December 31, 2022, the target annual bonuses for Ms. Morrison and Mr. Broxson, Campagna and Cutler were equal to 50%, 40%, 40%, and 35%, respectively, of their applicable annual base salary.

Equity Incentive Compensation

On December 7, 2017, Q32’s board of directors adopted the 2017 Plan. Although Q32 does not have a formal policy with respect to the grant of equity incentive awards to Q32’s executive officers, Q32 believes that equity awards provide Q32’s executive officers with a strong link to Q32’s long-term performance, create an ownership culture and help to align the interests of Q32’s executives and Q32’s stockholders. In addition, Q32 believes that equity awards with a time-based vesting feature promote executive retention because this feature incentivizes Q32’s executive officers to remain in Q32’s employment during the applicable vesting period. Accordingly, Q32’s board of directors periodically reviews the equity incentive compensation of Q32’s NEOs and from time to time may grant equity incentive awards to them. In 2022, Q32 granted options to Q32’s NEOs with the aggregate grant date fair values set forth in the Summary Compensation Table above.

Perquisites

Q32 generally does not provide perquisites to its employees, other than certain de minimis perquisites available to all of our employees, including its NEOs.

401(k) Plan

Q32 maintains the Q32 Bio Inc. 401(K) Plan, a tax-qualified retirement plan that provides eligible employees, including the NEOs, with an opportunity to save for retirement on a tax-advantaged basis. Plan participants are able to defer eligible compensation subject to applicable annual limits under the Code. Participants pre-tax or Roth contributions are allocated to each participant’s individual account and are then invested in selected investment alternatives according to the participants’ directions. Participants are immediately and fully vested in their contributions. Q32’s 401(k) plan is intended to be qualified under Section 401(a) of the Code with its 401(k) plan’s related trust intended to be tax exempt under Section 501(a) of the Code.

 

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Offer Letters with Q32’s Named Executive Officers

Q32 has entered into offer letters with each of its NEOs, which set forth the terms and conditions of each executive’s employment relationship. The terms of which are described below.

Offer Letter with Ms. Jodie Morrison

Q32 entered into an offer letter with Ms. Morrison, dated September 8, 2022, as amended on October 19, 2023, pursuant to which Q32 employs Ms. Morrison as its Chief Executive Officer and President. Pursuant to her offer letter, Ms. Morrison receives an initial annual base salary of $250,000, which increased to $500,000 effective as of November 1, 2022 in connection with the commencement of her full-time employment and subsequently increased to $545,000 effective as of October 19, 2023 in connection with her amendment to her offer letter. Ms. Morrison is also eligible to receive a target annual bonus of 50% her base salary and is eligible to participate in the employee benefit plans generally available to Q32’s employees, subject to the terms of such plans. Pursuant to Ms. Morrison’s amendment to her offer letter, she will be entitled to a base salary and target annual bonus adjustment in which such compensation will be adjusted to be no less than the seventy-fifth (75th) percentile for chief executive officers at public biotechnology companies that are similar in size, development stage and location as Q32, as determined by the board of directors in its discretion, subject to Q32 going public, which such adjustment provision is expected to be triggered upon the consummation of the Merger. Finally, Ms. Morrison’s offer letter provides that she is eligible for two initial equity grants in the form of stock options, which were issued to Ms. Morrison in fiscal year 2022 and are included in the “Outstanding Equity Awards at 2022 Fiscal Year-End” below, with a third grant to be made upon Ms. Morrison becoming Q32’s full-time Chief Executive Officer and, until Q32’s public listing (which will be satisfied upon the consummation of the Merger), one or more true-up stock option awards following the consummation of each preferred stock financing and Q32’s public listing in which, together with previously granted awards, will represent 5% of Q32’s capital stock. Such grants shall not be made in connection with Q32’s public listing if such event occurs later than six months following October 19, 2023.

In the event of a “qualifying termination” (as defined in her offer letter), subject to Ms. Morrison’s execution of a separation agreement and a general release of claims in favor of Q32 (and, in its sole discretion, subject to a one-year post-employment noncompetition agreement), Ms. Morrison will be entitled to receive: (i) base salary continuation for twelve (12) months following her date of termination; (ii) pro-rated annual target bonus in the amount she would have received in the year of termination (payable on the same schedule as her base salary continuation); and (iii) if Ms. Morrison elects continued COBRA healthcare coverage, continued healthcare coverage in the amount contributed by Q32 for a period of nine (9) months.

In lieu of the severance payments and benefits described in the preceding paragraph, in the event that Ms. Morrison’s employment is terminated due to a qualifying termination, on or within twelve (12) months following a “change in control” (as defined in her offer letter), Ms. Morrison will be entitled to receive (i) a lump sum payment equal to base salary continuation for eighteen (18) months following her date of termination; (ii) 100% of the annual target bonus she would have received in the year of termination, payable in lump sum; (iii) if Ms. Morrison elects continued COBRA healthcare coverage, continued healthcare coverage in the amount contributed by Q32 for a period of nine (9) months; and (iv) full acceleration of any unvested time-based equity.

Offer Letter with Mr. Jason Campagna

Q32 entered into an offer letter with Mr. Campagna, dated February 11, 2021, pursuant to which Q32 employs Mr. Campagna as its Chief Medical Officer. Pursuant to his offer letter, Mr. Campagna receives an initial annual base salary of $425,000, which is subject to annual review and periodic adjustment. Mr. Campagna is also eligible to receive a target annual bonus of 40% his base salary and is also eligible to participate in the employee benefit plans generally available to Q32’s employees, subject to the terms of such plans. Finally, Mr. Campagna’s offer letter provides that he is eligible for two initial equity grants in the form of stock options, which were issued to Mr. Campagna in fiscal year 2021 and are included in the “Outstanding Equity Awards at 2022 Fiscal Year-End” below.

 

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In the event of a termination of Mr. Campagna’s employment by Q32 without “cause” or Mr. Campagna resigns for “good reason” (as each term is defined in his offer letter), subject to Mr. Campagna’s execution of a separation agreement and a general release of claims in favor of Q32, Mr. Campagna will be entitled to receive (i) base salary continuation for nine (9) months following his date of termination; and (ii) if Mr. Campagna elects continued COBRA healthcare coverage, continued healthcare coverage in the amount contributed by Q32 for a period of six (6) months.

In addition to the severance payments and benefits described in the preceding paragraph, in the event that Mr. Campagna’s employment is terminated by Q32 without cause or Mr. Campagna resigns for good reason, in each case, within twelve (12) months following a “sale event” (as defined in the 2017 Plan), Mr. Campagna will also be entitled to receive (i) an additional six (6) months of continued healthcare, resulting in a total of twelve (12) months of continued healthcare; and (ii) full acceleration of the unvested equity awards referenced in his offer letter.

Offer Letter with Mr. Adam Cutler

Q32 entered into an offer letter with Mr. Cutler, dated May 25, 2021, pursuant to which Q32 previously employed Mr. Cutler as our Chief Financial Officer. Pursuant to his offer letter, Mr. Cutler received an initial annual base salary of $415,000, which was subject to annual review and periodic adjustment. Mr. Cutler was also eligible to receive a target annual bonus of 35% his base salary and was eligible to participate in the employee benefit plans generally available to Q32’s employees, subject to the terms of such plans. Finally, Mr. Cutler’s offer letter provided that he was eligible for two initial equity grants in the form of stock options, which were issued to Mr. Cutler in fiscal year 2021 and are included in the “Outstanding Equity Awards at 2022 Fiscal Year-End” below.

In the event of a termination of Mr. Cutler’s employment by Q32 without “cause” or Mr. Cutler resigns for “good reason” (as each term is defined in his offer letter), subject to Mr. Cutler’s execution of a separation agreement and a general release of claims in favor of Q32 Mr. Cutler will be entitled to receive: (i) base salary continuation for nine (9) months following his date of termination; and (ii) if Mr. Cutler elects continued COBRA healthcare coverage, continued healthcare coverage in the amount contributed by Q32 for a period of six (6) months.

In addition to the severance payments and benefits described in the preceding paragraph, in the event that Mr. Cutler’s employment is terminated by Q32 without cause or Mr. Cutler resigns for good reason, in each case, within three (3) months prior to or twelve (12) months following a “sale event” (as defined in the 2017 Plan), Mr. Cutler will also be entitled to receive (i) an additional six (6) months of continued healthcare, resulting in a total of twelve (12) months of continued healthcare; and (ii) full acceleration of the unvested equity awards referenced in his offer letter.

Arrangements with Mr. Broxson

Q32 entered into a separation agreement, dated September 5, 2022, with Mr. Broxson in connection with his termination. Pursuant to his separation agreement, Mr. Broxson was entitled to receive (i) base salary continuation for a period of twelve (12) months, (ii) if Mr. Broxson elects continued COBRA healthcare coverage, continued healthcare coverage in the amount contributed by Q32 until the earlier of (A) September 30, 2023 and (B) the date he becomes eligible for health benefits through another employer or otherwise becomes ineligible for COBRA, (iii) acceleration of vesting of the portion of options that would have vested on or before December 31, 2022, and (iv) an extended post-termination exercise period for a period of two years following the date of termination for any vested shares subject to his stock options.

 

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Outstanding Equity Awards at 2022 Fiscal Year-End

The following table sets forth information concerning outstanding equity awards held by each of the NEOs as of December 31, 2022.

 

     Option Awards (1)  

Name

   Vesting
Commencement
Date
    Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
     Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
     Option
Exercise
Price
($)
     Option
Expiration
Date
 

Jodie Morrison

     09/08/2022  (2)      198,768        2,981,520        0.36        11/16/2032  
     11/01/2022  (2)      66,256        3,114,032        0.36        11/16/2032  

Michael Broxson

     02/18/2020  (3)      1,995,541        —        0.33        03/03/2030  
     12/02/2020  (4)      750,000        —        0.35        12/01/2030  

Adam Cutler

     07/06/2021  (3)      560,906        1,022,830        0.35        09/16/2031  
     12/17/2021  (3)      70,990        212,970        0.35        12/16/2031  

Jason Campagna

     03/08/2021  (5)      799,459        1,027,877        0.35        03/24/2031  
     12/17/2021  (3)      93,469        280,408        0.35        12/16/2031  

 

(1)

Each equity award is subject to the terms of Q32’s 2017 Plan and the applicable award agreement.

(2)

The shares subject to the stock option vest in 48 equal monthly installments following the vesting commencement date, in each case, subject to the NEO’s continuous service relationship with Q32 through each applicable vesting date; provided that, in the event that Ms. Morrison is experiences a “qualifying termination” on or within the twelve month period following a “change in control,” all unvested options shall accelerate and become fully vested and exercisable.

(3)

1/4 of the shares subject to the stock option vest on the first anniversary of the vesting commencement date, and 1/48 of the shares subject to the stock option vest each month thereafter, in each case, subject to the NEO’s continuous service relationship with Q32 through each applicable vesting date; provided that, for Mr. Cutler and Campagna, in the event that any such executive is terminated by Q32 without “cause” or any executive resigns for “good reason,” in each case, within twelve months following a “sale event,” all unvested options shall accelerate and become fully vested and exercisable; provided further, for Mr. Broxson, in connection with his termination, the portion of options that would have vested on or before December 31, 2022 were accelerated and became fully vested and exercisable.

(4)

The shares subject to the stock option vest in 16 equal quarterly installments following the vesting commencement date, in each case, subject to the NEO’s continuous service relationship with Q32 through each applicable vesting date; provided that, for Mr. Broxson, in connection with his termination, the portion of options that would have vested on or before December 31, 2022 were accelerated and became fully vested and exercisable.

Employee benefit and equity compensation plans and arrangements

2017 Stock Option and Grant Plan

Q32’s 2017 Plan was initially adopted by its board of directors, and subsequently approved by its stockholders, on December 7, 2017.

Authorized Shares. Under Q32’s 2017 Plan, Q32 has reserved for issuance an aggregate of 25,956,535 shares of our common stock, which number is subject to adjustment in the event of a reorganization, stock split, reverse stock split, stock dividend, recapitalization, reclassification or other similar change in capitalization or event. The shares of common stock underlying any awards granted under its 2017 Plan that are forfeited, cancelled, reacquired by Q32 prior to vesting, satisfied without the issuance of common stock or otherwise terminated (other than by exercise) and shares that are withheld upon exercise of an option or settlement of an award to cover the

 

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exercise price or tax withholding are currently added to the shares of common stock available for issuance under Q32’s 2017 Plan.

Administration. Q32’s board of directors has acted as administrator of Q32’s 2017 Plan. The administrator has full power to select, from among the individuals eligible for awards, the individuals to whom awards will be granted and to determine the specific terms and conditions of each award, subject to the provisions of Q32’s 2017 Plan.

Eligibility. Persons eligible to participate in Q32’s 2017 Plan are Q32’s full or part-time officers, employees, directors, consultants and other key persons as selected from time to time by the administrator in its discretion.

Awards. Q32’s 2017 Plan permits the granting of (i) options to purchase common stock intended to qualify as incentive stock options under Section 422 of the Code and (ii) options that do not so qualify. The option exercise price of each option is determined by the administrator but may not be less than 100% of the fair market value of the common stock on the date of grant. The term of each option is fixed by the administrator and may not exceed ten years from the date of grant. The administrator determines at what time or times each option may be exercised. In addition, Q32’s 2017 Plan permits the granting of restricted shares of common stock, unrestricted shares of common stock and restricted stock units.

Sale Events. Q32’s 2017 Plan provides that upon the occurrence of a “sale event” (as defined in Q32’s 2017 Plan), all outstanding stock options will terminate at the effective time of such sale event, unless the parties to the sale event agree that such awards will be assumed or continued by the successor entity. In the event of a termination of Q32’s 2017 Plan and all options issued thereunder in connection with a sale event, optionees will be provided an opportunity to exercise options that are then exercisable or will become exercisable as of the effective time of the sale event prior to the consummation of the sale event. In addition, Q32 has the right to provide for cash payment to holders of options, in exchange for the cancellation thereof, in an amount equal to the difference between the value of the consideration payable per share of common stock in the sale event and the per share exercise price of such options, multiplied by the number of shares subject to such option to the extent then vested and exercisable. In the event of and subject to the consummation of a sale event, unvested restricted stock and restricted stock units (other than those becoming vested as a result of the sale event) will be forfeited immediately prior to the effective time of a sale event unless such awards are assumed or continued by the successor entity. If shares of restricted stock are forfeited in connection with a sale event, those shares of restricted stock shall be repurchased at a price per share equal to the original per share purchase price of such shares. Q32 has the right to provide for cash payment to holders of restricted stock or restricted stock units, in exchange for the cancellation thereof, in an amount per share equal to the value of the consideration payable per share of common stock in the sale event.

Amendment. Q32’s board of directors may amend or discontinue Q32’s 2017 Plan at any time, subject to stockholder approval where required by applicable law. The administrator of Q32’s 2017 Plan may also amend or cancel any outstanding award, provided that no amendment to an award may adversely affect a participant’s rights without his or her consent. The administrator of Q32’s 2017 Plan is specifically authorized to exercise its discretion to reduce the exercise price of outstanding stock options or effect the repricing of such awards through cancellation and re-grants.

As of November 30, 2023, options to purchase up to 24,131,511 shares of Q32’s common stock were outstanding under Q32’s 2017 Plan.

2024 Stock Option and Incentive Plan

On                , 2024, Homology’s board of directors, subject to stockholder approval, adopted the 2024 Plan. If Homology’s stockholders approve the 2024 Plan, it will become effective upon the closing of the Merger. For a summary of the 2024 Plan, see Proposal No. 4 in this proxy statement/prospectus.

 

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2024 Employee Stock Purchase Plan

On                , 2024, Homology’s board of directors, subject to stockholder approval, adopted the 2024 ESPP. If Homology’s stockholders approve the 2024 ESPP, it will become effective upon the closing of the Merger. For a summary of the 2024 ESPP, see Proposal No. 5 in this proxy statement/prospectus.

 

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CERTAIN RELATED PERSON TRANSACTIONS OF HOMOLOGY

Policies and Procedures for Related Person Transactions

Homology’s board of directors has adopted a written Related Person Transaction Policy, setting forth the policies and procedures for the review and approval or ratification of related person transactions. Under the policy, Homology’s finance department is primarily responsible for developing and implementing processes and procedures to obtain information regarding related persons with respect to potential related person transactions and then determining, based on the facts and circumstances, whether such potential related person transactions do, in fact, constitute related person transactions requiring compliance with the policy. If Homology’s finance department determines that a transaction or relationship is a related person transaction requiring compliance with the policy, its Chief Financial Officer is required to present to the audit committee all relevant facts and circumstances relating to the related person transaction. Homology’s audit committee must review the relevant facts and circumstances of each related person transaction, including if the transaction is on terms comparable to those that could be obtained in arm’s length dealings with an unrelated third party and the extent of the related person’s interest in the transaction, take into account the conflicts of interest and corporate opportunity provisions of Homology’s code of business conduct and ethics, and either approve or disapprove the related person transaction. If advance audit committee approval of a related person transaction requiring the audit committee’s approval is not feasible, then the transaction may be preliminarily entered into by management upon prior approval of the transaction by the chair of the audit committee subject to ratification of the transaction by the audit committee at the audit committee’s next regularly scheduled meeting; provided, that if ratification is not forthcoming, management will make all reasonable efforts to cancel or annul the transaction. If a transaction was not initially recognized as a related person, then upon such recognition the transaction will be presented to the audit committee for ratification at the audit committee’s next regularly scheduled meeting; provided, that if ratification is not forthcoming, management will make all reasonable efforts to cancel or annul the transaction. Homology’s management will update the audit committee as to any material changes to any approved or ratified related person transaction and will provide a status report at least annually of all then current related person transactions. No director may participate in approval of a related person transaction for which he or she is a related person.

The following are currently proposed transactions and certain transactions, arrangements and relationships since January 1, 2021 with Homology’s directors, executive officers and stockholders owning 5% or more of its outstanding common stock.

Stock Purchase Agreement with Pfizer

On November 9, 2020, Homology entered into a stock purchase agreement, or the Stock Purchase Agreement, with Pfizer Inc., or Pfizer, which holds approximately 8.7% of Homology’s common stock as of March 1, 2023, pursuant to which Pfizer purchased 5,000,000 shares of Homology’s common stock through a private placement transaction at a purchase price of $12.00 per share, for an aggregate purchase price of $60.0 million. Under the Stock Purchase Agreement, Pfizer was granted an exclusive ROFR for a 30-month period beginning on the date of the closing of the private placement to negotiate a potential collaboration on the development and commercialization of HMI-102 and HMI-103. Pfizer may exercise its right of first refusal under the ROFR one time for each of HMI-102 and HMI-103 during the ROFR period. Additionally, Pfizer has designated a member to join Homology’s Scientific Advisory Board to participate in matters related to the development of these programs. For more information regarding Pfizer and its equity holdings, see the section in this proxy statement/prospectus entitled “Principal Stockholders of Homology.”

Employment Agreements

Homology has entered into employment agreements with its named executive officers.

 

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Indemnification Agreements

Homology has entered into indemnification agreements with each of its directors and executive officers. These agreements, among other things, require Homology or will require Homology to indemnify each director (and in certain cases their related venture capital funds) and executive officer to the fullest extent permitted by Delaware law, including indemnification of expenses such as attorneys’ fees, judgments, fines and settlement amounts incurred by the director or executive officer in any action or proceeding, including any action or proceeding by or in right of Homology, arising out of the person’s services as a director or executive officer.

 

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CERTAIN RELATED PERSON TRANSACTIONS OF THE COMBINED COMPANY

In addition to the compensation arrangements, including employment, termination of employment and change in control arrangements, with Q32’s and Homology’s directors and executive officers, including those discussed in the sections titled “Directors and Officers of Homology Following the Merger,” “Q32 Executive and Director Compensation” and “Homology Executive and Director Compensation,” the following is a description of each transaction involving Homology since January 1, 2021, each transaction involving Q32 since January 1, 2021 and each currently proposed transaction in which:

 

  •  

either Q32 or Homology has been or is to be a participant;

 

  •  

the amounts involved exceeded or will exceed the lesser of $120,000 and 1% of the average of Q32’s or Homology’s total assets at year-end for the last two completed fiscal years, as applicable; and

 

  •  

in the case of Homology, any of Homology’s directors, executive officers or holders of more than 5% of Homology’s capital stock, or an affiliate or immediate family member of the foregoing persons, had or will have a direct or indirect material interest; and in the case of Q32 any of Q32’s directors or executive officers who will become directors or executive officers of the combined company, or holders of more than 5% of Q32’s capital stock who will become holders of more than 5% of the combined company’s capital stock, or an affiliate or immediate family member of the foregoing persons, had or will have a direct or indirect material interest.

Homology Transactions

The following are certain transactions, arrangements and relationships with Homology’s directors, executive officers and stockholders owning 5% or more of Homology’s outstanding common stock since January 1, 2021.

Stock Purchase Agreement with Pfizer

On November 9, 2020, Homology entered into a stock purchase agreement, or the Stock Purchase Agreement, with Pfizer Inc., or Pfizer, which holds approximately 8.6% of Homology’s common stock as of November 30, 2023, pursuant to which Pfizer purchased 5,000,000 shares of Homology common stock through a private placement transaction at a purchase price of $12.00 per share, for an aggregate purchase price of $60.0 million. Under the Stock Purchase Agreement, Pfizer was granted an exclusive ROFR for a 30-month period beginning on the date of the closing of the private placement to negotiate a potential collaboration on the development and commercialization of HMI-102 and HMI-103. Pfizer had a right of first refusal under the ROFR one time for each of HMI-102 and HMI-103 during the ROFR period. Additionally, Pfizer has designated a member to join our Scientific Advisory Board to participate in matters related to the development of these programs. The ROFR period expired in May 2023. For more information regarding Pfizer and its equity holdings, see the section titled “Principal Stockholders of Homology” in this proxy statement/prospectus.

Employment Agreements

Homology has entered into employment agreements with certain executive officers. Compensation arrangements for Homology executive officers are described elsewhere in this proxy statement/prospectus in the section titled “Interests of Homology Directors and Executive Officers in the Merger.”

Indemnification Agreements

Homology has entered into indemnification agreements with each of its directors and executive officers. These agreements, among other things, require Homology or will require Homology to indemnify each director (and in certain cases their related venture capital funds) and executive officer to the fullest extent permitted by Delaware law, including indemnification of expenses such as attorneys’ fees, judgments, fines and settlement amounts incurred by the director or executive officer in any action or proceeding, including any action or proceeding by or in right of us, arising out of the person’s services as a director or executive officer.

 

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Q32 Transactions

The following is a description of transactions or series of transactions since January 1, 2021, to which Q32 was or will be a party, in which:

 

  •  

the amount involved in the transaction exceeds, or will exceed, the lesser of $120,000 or one percent of the average of Q32’s total assets for the last two completed fiscal years; and

 

  •  

in which any of Q32’s directors or executive officers who will become directors or executive officers of the combined company, or holders of more than 5% of Q32’s capital stock who will become holders of more than 5% of the combined company’s capital stock, or an affiliate or immediate family member of the foregoing persons, had or will have a direct or indirect material interest.

Compensation arrangements for Q32 named executive officers and directors are described elsewhere in this proxy statement/prospectus in the section titled “Q32 Executive and Director Compensation.”

Private Placements of Securities

Series B Convertible Preferred Stock Financing – Second Closing

In November and December 2021, Q32 sold an aggregate of 18,229,873 shares of Series B preferred stock at a purchase price of $1.0971 per share for aggregate gross proceeds of approximately $19.9 million in the second closing of Series B preferred stock, or the Second Series B Closing. The following table summarizes purchases of Q32’s Series B preferred stock by related persons in the Second Series B Closing:

 

Participant    Shares of
Series B
Preferred
Stock
     Total Cash
Purchase
Price
($)
 

Abingworth Bioventures VII LP (1)

     1,671,072        1,833,333  

Acorn Bioventures, L.P. (2)

     3,465,975        3,999,999  

Atlas Venture Opportunity Fund I, L.P. (3)

     3,494,060        3,833,333  

OrbiMed Private Investments VII, LP (4)

     4,557,469        4,999,999  

 

(1)

Abingworth Bioventures VII LP, or ABV VII, may be deemed to beneficially own more than 5% of Q32’s outstanding capital stock. Jayson Punwani is a Partner at Abingworth LLP, which has the power to control investment decisions with respect to the securities held of record by ABV VII, and a member of Q32’s board of directors.

(2)

Acorn Bioventures, L.P., or Acorn, beneficially owns more than 5% of Q32’s outstanding capital stock. Isaac Manke is a General Partner at Acorn and a member of Q32’s board of directors.

(3)

Atlas Venture Opportunity Fund I, L.P., or Atlas Opportunity I, and entities affiliated with Atlas Opportunity I, beneficially own more than 5% of Q32’s outstanding capital stock. David Grayzel is a Partner at Atlas Venture Life Science Advisors, LLC and a member of Q32’s board of directors.

(4)

These shares are held by OrbiMed Private Investments VII, LP, or OPI VII. OrbiMed Capital VII LLC, or GP VII, is the general partner of OPI VII. OrbiMed Advisors LLC, or OrbiMed Advisors, is the managing member of GP VII. By virtue of such relationships, GP VII and OrbiMed Advisors may be deemed to have beneficial ownership over such shares. OrbiMed Advisors exercises investment and voting power through a management committee comprised of Carl L. Gordon, Sven H. Borho, and W. Carter Neild. Diyong Xu, a member of Q32’s board of directors, is an employee of OrbiMed Advisors. Each of Dr. Gordon and Messrs. Borho, Neild, and Xu disclaim beneficial ownership of the shares held by OPI VII.

Q32 Convertible Note Financing

In May 2022, Q32 entered into a note purchase agreement with certain existing investors to purchase up to an aggregate of $30.0 million in convertible notes, or the Convertible Notes, through December 31, 2022. The Convertible Notes bear interest at 5.0% per annum. The Convertible Notes become due on demand of the holders

 

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of the Convertible notes one year from the date of issuance. In May, August and December 2022, Q32 received $8.3 million, $5.0 million, and $16.7 million, respectively, in exchange for issuance of the Convertible Notes.

The Convertible Notes contain mandatory conversion features whereby the total outstanding amount of principal and accrued and unpaid interest of the Convertible Notes shall automatically convert into shares of Q32’s common stock or preferred stock, as applicable, (i) upon an initial public offering of the Q32’s common stock, (ii) upon the Q32’s issuance and sale of shares of a new series of preferred stock to one or more investors in a private transaction provided, in each case, Q32 receives aggregate gross proceeds of at least $25.0 million, or, (i) and (ii) collectively, a mandatory conversion event. The value of the Convertible Notes plus accrued interest, if any, convert into shares of Q32’s common stock or preferred stock, as applicable, at 90% of the purchase price of the per share purchase price of common stock or preferred stock, as applicable, in a mandatory conversion event.

If the mandatory conversion events do not occur and if the Convertible Notes have not been repaid by the maturity date for the Convertible Notes, the holders of the Convertible Notes may request the Convertible Notes plus accrued interest, if any, to be converted into Series B preferred stock at the Series B preferred stock convertible price of $1.0971.

In August 2022, Q32 entered into an amendment to the note purchase agreement with an aggregate principal amount of $5,000,001 Convertible Notes sold to Bristol-Myers Squibb Company, or BMS. In June 2023, Q32 entered into an amendment to the Convertible Notes extending the maturity date of the Convertible Notes to December 23, 2023. Immediately prior to the Effective Time, the Company shall cause the outstanding principal and accrued but unpaid interest on Q32 Convertible Notes to be converted into the applicable number of shares of Q32 Common Stock provided for under the terms of such Q32 Convertible Note, or the Convertible Notes Conversion,. All of Q32 Convertible Notes converted into shares of Q32 Common Stock shall no longer be outstanding and shall cease to exist, and each holder of Q32 Convertible Notes shall thereafter cease to have any rights with respect to Q32 Convertible Notes. Immediately following the Convertible Notes Conversion, at the Effective Time and by virtue of the Merger, all shares of Q32 Common Stock issued in the Convertible Notes Conversion shall be canceled and converted into the right to receive Homology Common Stock pursuant to the Merger Agreement.

The following table summarizes the aggregate amount of Convertible Notes purchased by related persons.

 

Participant    Aggregate Amount of
Convertible Notes
($)
 

Abingworth Bioventures VII LP (1)

     3,644,352  

Acorn Bioventures, L.P. (2)

     2,655,105  

Atlas Venture Opportunity Fund II, L.P. (3)

     6,913,845  

Bristol-Myers Squibb Company (4)

     5,000,001  

OrbiMed Private Investments VII, LP (5)

     7,445,508  

 

(1)

Abingworth Bioventures VII LP, or ABV VII, may be deemed to beneficially own more than 5% of Q32’s outstanding capital stock. Jayson Punwani is a Partner at Abingworth LLP, which has the power to control investment decisions with respect to the securities held of record by ABV VII, and a member of Q32’s board of directors.

(2)

Acorn Bioventures, L.P., or Acorn, beneficially owns more than 5% of Q32’s outstanding capital stock. Isaac Manke is a General Partner at Acorn and a member of Q32’s board of directors.

(3)

Atlas Venture Opportunity Fund II, L.P., or Atlas Opportunity II, and entities affiliated with Atlas Opportunity II beneficially own more than 5% of Q32’s outstanding capital stock. David Grayzel is a Partner at Atlas Venture Life Science Advisors, LLC and a member of Q32’s board of directors.

(4)

BMS beneficially owns more than 5% of Q32’s outstanding capital stock.

 

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(5)

These convertible notes are held by OrbiMed Private Investments VII, LP, or OPI VII. OrbiMed Capital VII LLC, or GP VII, is the general partner of OPI VII. OrbiMed Advisors LLC, or OrbiMed Advisors, is the managing member of GP VII. By virtue of such relationships, GP VII and OrbiMed Advisors may be deemed to have beneficial ownership over such shares. OrbiMed Advisors exercises investment and voting power through a management committee comprised of Carl L. Gordon, Sven H. Borho, and W. Carter Neild. Diyong Xu, a member of Q32’s board of directors, is an employee of OrbiMed Advisors. Each of Dr. Gordon and Messrs. Borho, Neild, and Xu disclaim beneficial ownership of the convertible notes held by OPI VII.

Q32 Pre-Closing Financing

In connection with the Merger Agreement, Q32 entered into a Subscription Agreement in November 2023 with certain investors to consummate the Pre-Closing Financing. Pursuant to the Subscription Agreement, the investors agreed to purchase an aggregate of 35,032,111 shares of Q32 common stock, at a price of $1.989 per share, for aggregate gross proceeds of approximately $42.0 million. The closing of the Pre-Closing Financing is conditioned upon the satisfaction or waiver of the conditions to the Merger as well as certain other conditions. Five of the investors or their affiliates are beneficial holders of more than 5% of Q32’s capital stock, and the table below sets forth the number of shares of Q32 common stock expected to be purchased by such holders at the closing of the Pre-Closing Financing:

 

Participant    Shares of
Q32
Common
Stock
     Total
Purchase
Price
($)
 

Abingworth Bioventures VII LP (1)

     4,332,673        5,194,442  

Acorn Bioventures, L.P. (2)

     3,156,665        3,784,526  

Atlas Venture Opportunity Fund II, L.P. (3)

     8,219,904        9,854,843  

Bristol-Myers Squibb Company (4)

     4,170,490        5,000,000  

OrbiMed Private Investments VII, LP (5)

     8,852,000        10,612,663  

 

(1)

Abingworth Bioventures VII LP, or ABV VII, may be deemed to beneficially own more than 5% of Q32’s outstanding capital stock. Jayson Punwani is a Partner at Abingworth LLP, which has the power to control investment decisions with respect to the securities held of record by ABV VII, and a member of Q32’s board of directors.

(2)

Acorn Bioventures, L.P., or Acorn, beneficially owns more than 5% of Q32’s outstanding capital stock. Isaac Manke is a General Partner at Acorn and a member of Q32’s board of directors.

(3)

Atlas Venture Opportunity Fund II, L.P., or Atlas Opportunity II, and entities affiliated with Atlas Opportunity II beneficially own more than 5% of Q32’s outstanding capital stock. David Grayzel is a Partner at Atlas Venture Life Science Advisors, LLC and a member of Q32’s board of directors.

(4)

BMS beneficially owns more than 5% of Q32’s outstanding capital stock.

(5)

These shares will be held by OrbiMed Private Investments VII, LP, or OPI VII. OrbiMed Capital VII LLC, or GP VII, is the general partner of OPI VII. OrbiMed Advisors LLC, or OrbiMed Advisors, is the managing member of GP VII. By virtue of such relationships, GP VII and OrbiMed Advisors may be deemed to have beneficial ownership over such shares. OrbiMed Advisors exercises investment and voting power through a management committee comprised of Carl L. Gordon, Sven H. Borho, and W. Carter Neild. Diyong Xu, a member of Q32’s board of directors, is an employee of OrbiMed Advisors. Each of Dr. Gordon and Messrs. Borho, Neild, and Xu disclaim beneficial ownership of the shares to be held by OPI VII.

Other Agreements with Q32 Stockholders

In connection with Q32’s Series B convertible preferred stock financing, Q32 entered into investors’ rights, voting and right of first refusal and co-sale agreements containing registration rights, information rights, voting

 

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rights and rights of first refusal, among other things, with certain holders of Q32 preferred stock and certain holders of Q32 common stock. These stockholder agreements will terminate upon the closing of the Merger.

Indemnification Agreements

Q32 has entered into agreements to indemnify its directors and executive officers. These agreements will, among other things, require Q32 to indemnify these individuals for certain expenses (including attorneys’ fees), judgments, fines and settlement amounts reasonably incurred by such person in any action or proceeding, including any action by or in Q32’s right, on account of any services undertaken by such person on Q32’s behalf or that person’s status as a member of Q32’s board of directors to the maximum extent allowed under Delaware law.

Policies for Approval of Related Party Transactions

Q32’s board of directors reviews and approves transactions with its directors, officers and holders of 5% or more of its voting securities and their affiliates, each a related party. Prior such transaction, the material facts as to the related party’s relationship or interest in the transaction are disclosed to Q32’s board of directors prior to their consideration of such transaction, and the transaction is not considered approved by the board of directors unless a majority of the directors who are not interested in the transaction approve the transaction. Further, when stockholders are entitled to vote on a transaction with a related party, the material facts of the related party’s relationship or interest in the transaction are disclosed to the stockholders, who must approve the transaction in good faith.

 

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HOMOLOGY’S DESCRIPTION OF CAPITAL STOCK

The following description summarizes some of the terms of Homology’s restated certificate of incorporation and its amended and restated bylaws and of the DGCL This description is summarized from, and qualified in its entirety by reference to, Homology’s restated certificate of incorporation and its amended and restated bylaws, each of which has been publicly filed with the SEC.

Homology’s authorized capital stock consists of:

 

  •  

200,000,000 shares of common stock, par value $0.0001 per share; and

 

  •  

10,000,000 shares of preferred stock, par value $0.0001 per share.

Common Stock

Homology’s common stock is listed on the Nasdaq Global Select Market under the symbol “FIXX.”

Voting Rights. Holders of Homology’s common stock are entitled to one vote for each share held on all matters submitted to a vote of stockholders and do not have cumulative voting rights. An election of directors by Homology’s stockholders shall be determined by a plurality of the votes cast by the stockholders entitled to vote on the election. Subject to the supermajority votes for some matters, other matters shall be decided by the affirmative vote of Homology’s stockholders having a majority in voting power of the votes cast by the stockholders present or represented and voting on such matter. Homology’s restated certificate of incorporation and amended and restated bylaws also provide that its directors may be removed only for cause and only by the affirmative vote of the holders of at least two-thirds in voting power of the outstanding shares of capital stock entitled to vote thereon. In addition, the affirmative vote of the holders of at least two-thirds in voting power of the outstanding shares of capital stock entitled to vote thereon is required to amend or repeal, or to adopt any provision inconsistent with, several of the provisions of Homology’s restated certificate of incorporation. See below under “—Anti-Takeover Effects of Delaware Law and Homology’s Certificate of Incorporation and Bylaws—Amendment of Charter Provisions.”

Rights Upon Liquidation. In the event of Homology’s liquidation or dissolution, the holders of common stock are entitled to receive proportionately Homology’s net assets available for distribution to stockholders after the payment of all debts and other liabilities and subject to the prior rights of any outstanding preferred stock.

Other Rights. Holders of common stock have no preemptive, subscription, redemption or conversion rights. Homology’s outstanding shares of common stock are, when issued and paid for, validly issued, fully paid and nonassessable. The rights, preferences and privileges of holders of common stock are subject to and may be adversely affected by the rights of the holders of shares of any series of preferred stock that Homology may designate and issue in the future.

Transfer Agent

The transfer agent and registrar for Homology’s common stock is American Stock Transfer & Trust Company, LLC.

Dividend

Holders of common stock are entitled to receive proportionately any dividends as may be declared by Homology’s board of directors, subject to any preferential dividend rights of outstanding preferred stock. Homology has never declared or paid any cash dividends on its common stock. Homology does not intend to declare or pay cash dividends for the foreseeable future. Homology currently expects to retain all future earnings, if any, for use in the development, operation and expansion of its business. Any determination to pay cash

 

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dividends in the future will depend upon, among other things, Homology’s results of operations, plans for expansion, tax considerations, available net profits and reserves, limitations under law, financial condition, capital requirements and other factors that Homology’s board of directors considers to be relevant.

Preferred Stock

Under the terms of Homology’s restated certificate of incorporation, Homology’s board of directors is authorized to issue shares of preferred stock in one or more series without stockholder approval. Homology’s board of directors has the discretion to determine the rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences, of each series of preferred stock.

The purpose of authorizing Homology’s board of directors to issue preferred stock and determine its rights and preferences is to eliminate delays associated with a stockholder vote on specific issuances. The issuance of preferred stock, while providing flexibility in connection with possible acquisitions, future financings and other corporate purposes, could have the effect of making it more difficult for a third party to acquire, or could discourage a third party from seeking to acquire, a majority of Homology’s outstanding voting stock.

Anti-Takeover Effects of Delaware Law and Homology’s Certificate of Incorporation and Bylaws

Some provisions of Delaware law, Homology’s restated certificate of incorporation and its amended and restated bylaws could make the following transactions more difficult: an acquisition of Homology by means of a tender offer; an acquisition of Homology by means of a proxy contest or otherwise; or the removal of Homology’s incumbent officers and directors. It is possible that these provisions could make it more difficult to accomplish or could deter transactions that stockholders may otherwise consider to be in their best interest or in Homology’s best interests, including transactions which provide for payment of a premium over the market price for its shares.

These provisions, summarized below, are intended to discourage coercive takeover practices and inadequate takeover bids. These provisions are also designed to encourage persons seeking to acquire control of Homology to first negotiate with its board of directors. Homology believes that the benefits of the increased protection of its potential ability to negotiate with the proponent of an unfriendly or unsolicited proposal to acquire or restructure Homology outweigh the disadvantages of discouraging these proposals because negotiation of these proposals could result in an improvement of their terms.

Undesignated Preferred Stock

The ability of Homology’s board of directors, without action by the stockholders, to issue up to 10,000,000 shares of undesignated preferred stock with voting or other rights or preferences as designated by its board of directors could impede the success of any attempt to change control of it. These and other provisions may have the effect of deferring hostile takeovers or delaying changes in control or management of Homology.

Stockholder Meetings

Homology’s amended and restated bylaws provide that a special meeting of stockholders may be called only by its chairman of the board, chief executive officer or president (in the absence of a chief executive officer), or by a resolution adopted by a majority of its board of directors.

Requirements for Advance Notification of Stockholder Nominations and Proposals

Homology’s amended and restated bylaws establish advance notice procedures with respect to stockholder proposals to be brought before a stockholder meeting and the nomination of candidates for election as directors, other than nominations made by or at the direction of the board of directors or a committee of the board of directors.

 

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Elimination of Stockholder Action by Written Consent

Homology’s restated certificate of incorporation eliminates the right of stockholders to act by written consent without a meeting.

Staggered Board

Homology’s board of directors is divided into three classes. The directors in each class will serve for a three-year term, one class being elected each year by Homology’s stockholders. This system of electing and removing directors may tend to discourage a third party from making a tender offer or otherwise attempting to obtain control of Homology, because it generally makes it more difficult for stockholders to replace a majority of the directors.

Removal of Directors

Homology’s restated certificate of incorporation and amended and restated bylaws provide that, subject to the rights of holders of any series of preferred stock, no member of its board of directors may be removed from office by its stockholders except for cause and, in addition to any other vote required by law, upon the approval of the holders of at least two-thirds in voting power of the outstanding shares of capital stock entitled to vote in the election of directors. Subject to the rights of holders of any series of preferred stock, any vacancy on Homology’s board of directors, including a vacancy resulting from an enlargement of its board of directors, may be filled only by vote of a majority of its directors then in office, unless its board of directors determines by resolution that any such vacancy or newly created directorship shall be filled by its stockholders.

Stockholders Not Entitled to Cumulative Voting

Homology’s restated certificate of incorporation does not permit stockholders to cumulate their votes in the election of directors. Accordingly, the holders of a majority of the outstanding shares of Homology’s common stock entitled to vote in any election of directors can elect all of the directors standing for election, if they choose, other than any directors that holders of its preferred stock may be entitled to elect.

Delaware Anti-Takeover Statute

Homology is subject to Section 203 of the General Corporation Law of the State of Delaware, which prohibits persons deemed to be “interested stockholders” from engaging in a “business combination” with a publicly held Delaware corporation for three years following the date these persons become interested stockholders unless the business combination is, or the transaction in which the person became an interested stockholder was, approved in a prescribed manner or another prescribed exception applies. Generally, an “interested stockholder” is a person who, together with affiliates and associates, owns, or within three years prior to the determination of interested stockholder status did own, 15% or more of a corporation’s voting stock. Generally, a “business combination” includes a merger, asset or stock sale, or other transaction resulting in a financial benefit to the interested stockholder. The existence of this provision may have an anti-takeover effect with respect to transactions not approved in advance by the board of directors.

Choice of Forum

Homology’s restated certificate of incorporation provides that, unless it consents in writing to an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for: (1) any derivative action or proceeding brought on its behalf; (2) any action asserting a claim of breach of a fiduciary duty or other wrongdoing by any of its directors, officers, employees or agents to it or its stockholders; (3) any action asserting a claim against it arising pursuant to any provision of the General Corporation Law of the State of Delaware or its restated certificate of incorporation or amended and restated bylaws; or (4) any action

 

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asserting a claim governed by the internal affairs doctrine. Homology’s restated certificate of incorporation also provides that any person or entity purchasing or otherwise acquiring any interest in shares of its capital stock will be deemed to have notice of and to have consented to this choice of forum provision. It is possible that a court of law could rule that the choice of forum provision contained in Homology’s restated certificate of incorporation is inapplicable or unenforceable if it is challenged in a proceeding or otherwise.

In addition, Homology’s amended and restated bylaws provide that unless it consents in writing to the selection of an alternative forum, to the fullest extent permitted by law, the federal district courts of the United States of America shall be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act of 1933, as amended, and any person or entity purchasing or otherwise acquiring or holding any interest in Homology’s shares of capital stock shall be deemed to have notice of and consented to this choice of forum provision.

Amendment of Charter Provisions

The amendment of any of the above provisions, except for the provision making it possible for Homology’s board of directors to issue preferred stock and the provision prohibiting cumulative voting, would require approval by holders of at least two-thirds in voting power of the outstanding shares of capital stock entitled to vote thereon.

The provisions of Delaware law, Homology’s restated certificate of incorporation and its amended and restated bylaws could have the effect of discouraging others from attempting hostile takeovers and, as a consequence, they may also inhibit temporary fluctuations in the market price of Homology’s common stock that often result from actual or rumored hostile takeover attempts. These provisions may also have the effect of preventing changes in the composition of Homology’s board and management. It is possible that these provisions could make it more difficult to accomplish transactions that stockholders may otherwise deem to be in their best interests.

 

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COMPARISON OF RIGHTS OF HOLDERS OF HOMOLOGY CAPITAL STOCK AND Q32 CAPITAL STOCK

If the Merger is completed, Q32 stockholders will receive shares of Homology common stock, pursuant to the terms of the Merger Agreement. Immediately prior to the closing of the Merger, Homology’s Restated Certificate of Incorporation will be amended to effect the Authorized Share Increase and the Reverse Stock Split, as set forth in the form of Certificate of Amendment attached as Annex G to this proxy statement/prospectus. In addition, after the completion of the Merger, Homology’s Restated Certificate of Incorporation will be amended to change its corporate name to “Q32 Bio Inc.”

Homology and Q32 are both incorporated under the laws of the State of Delaware. The rights of Homology stockholders and Q32 stockholders are generally governed by the DGCL. Upon completion of the Merger, Q32 stockholders will become Homology stockholders, and their rights will be governed by the DGCL, the Amended and Restated Bylaws of Homology and the Restated Certificate of Incorporation of Homology.

The material differences between the current rights of Q32 stockholders under the Q32 Second Amended and Restated Certificate of Incorporation and Bylaws and their rights as Homology stockholders, after the Merger, under the Homology Restated Certificate of Incorporation and the Amended and Restated Bylaws, both as will be in effect immediately following the completion of the Merger, are summarized below. The summary below does not purport to be complete and is subject to, and qualified in its entirety by reference to, the DGCL and the governing corporate instruments that are subject to amendment in accordance with their terms. You should carefully read this entire document and the other referenced documents, including the governing corporate instruments, for a more complete understanding of the differences between being a stockholder of Homology or Q32 before the Merger and being a Homology stockholder following the completion of the Merger.

 

Homology

  

Q32

Organizational Documents
The rights of Homology stockholders are governed by Homology’s Restated Certificate of Incorporation, Homology’s Amended and Restated Bylaws and the DGCL.    The rights of Q32 stockholders are governed by Q32’s Second Amended and Restated Certificate of Incorporation, Q32’s Bylaws and the DGCL.
Authorized Capital Stock

Homology is authorized to issue two classes of capital stock which are designated, respectively, “common stock” and “preferred stock.” The total number of shares that Homology is authorized to issue is 210,000,000, of which 200,000,000 shares are common stock, par value $0.0001 per share, and 10,000,000 shares are preferred stock, par value $0.0001 per share. The number of authorized shares of common stock may be increased or decreased (but not below the number of shares thereof then outstanding) by the affirmative vote of the holders of a majority of the stock of Homology entitled to vote,

irrespective of the provisions of Section 242(b)(2) of the DGCL. The number of authorized shares of Homology preferred stock may be increased or decreased (but not below the number of shares thereof then outstanding) by the affirmative vote of the holders of a majority of the

   Q32 is authorized to issue two classes of capital stock, which are designated, respectively, “common stock” and “preferred stock.” The total number of shares that Q32 is authorized to issue is 259,833,356, of which 141,900,000 shares are common stock, par value $0.0001 per share, and 117,933,356 shares are preferred stock, par value $0.0001 per share. The number of authorized shares of Q32 preferred stock may be increased or decreased (but not below the number of shares thereof then outstanding) by the affirmative vote of the holders of a majority of the outstanding shares of preferred stock, voting or consenting together as a single class on an as-converted basis, or the Required Vote, and, under certain circumstances, (i) the number of authorized shares of Q32’s Series B Preferred Stock may be increased or decreased only by the affirmative vote of

 

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Homology

  

Q32

stock of Homology entitled to vote, irrespective of the provisions of Section 242(b)(2) of the DGCL.    the holders of a majority of the outstanding shares of Series B Preferred Stock, and (ii) the number of authorized shares of Q32’s Series A Preferred Stock may be increased or decreased only by the affirmative vote of the holders of a majority of the outstanding shares of Series A Preferred Stock. The number of authorized shares of common stock may be increased or decreased (but not below the number of shares thereof then outstanding) by the affirmative vote of the Required Vote and the holders of a majority of the outstanding shares of Q32’s capital stock, given in writing or by vote at a meeting, irrespective of the provisions of Section 242(b)(2) of the DGCL.
Common Stock
Homology’s authorized common stock consists of 200,000,000 shares of common stock. Each holder of a share of Homology common stock is entitled to one vote for each such share held of record on the applicable record date on each matter voted on at a meeting of stockholders, provided, however, that, except as otherwise required by law, holders of Homology common stock will not be entitled to vote on any amendment to the Homology’s Restated Certificate of Incorporation, that relates solely to the terms of one or more outstanding series of Homology preferred stock if the holders of such affected series are entitled, either separately or together as a class with the holders of one or more other such series, to vote thereon pursuant to the Homology’s Restated Certificate of Incorporation or the DGCL.   

Q32’s authorized common stock consists of 141,900,000 shares of common stock.

 

Each holder of a share of Q32 common stock is entitled to one vote for each such share held of record on the applicable record date on each matter voted on at a meeting of stockholders.

Preferred Stock
Homology’s authorized preferred stock consists of 10,000,000 shares of preferred stock. No shares of Homology preferred stock are currently outstanding.    Q32’s authorized preferred stock consists of 117,933,356 shares of preferred stock, of which (a) 6,500,000 shares have been designated “Series A1 Preferred Stock”, all of which are currently issued and outstanding, (b) 47,628,788 shares have been designated “Series A Preferred Stock”, all of which are currently issued and outstanding, (c) 63,804,568 shares have been designated “Series B Preferred Stock”, of which 54,689,627 shares are currently issued and outstanding.
Number and Qualification of Directors
The Homology board of directors consists of one or more members, and the number of directors is fixed from time to time by resolution of the Homology board    The Q32 board of directors consists of one or more members, and the number of directors is fixed from time to time by resolution of the Q32 board of

 

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of directors. The Homology board of directors currently consists of six members. No decrease in the authorized number of directors constituting the Homology board of directors will shorten the term of any incumbent director. Directors of Homology need not be stockholders of Homology.    directors and by the written consent or vote of the requisite stockholders of Q32. The Q32 board of directors currently consists of eight members. No decrease in the authorized number of directors constituting the Q32 board of directors will shorten the term of any incumbent director. Directors of Q32 need not be stockholders of Q32.
Structure of Board of Directors; Term of Directors; Election of Directors
Other than any directors elected by the separate vote of the holders of any series of Homology preferred stock, the Homology board of directors is divided into three classes, designated as Class I, Class II and Class III, respectively. Directors are assigned to each class in accordance with a resolution or resolutions adopted by the Homology board of directors. Subject to the rights of holders of any series of Homology preferred stock to elect directors, each director will serve for a term ending on the date of the third annual meeting of stockholders following the annual meeting of stockholders at which such director was elected; provided that each director initially assigned to Class I will serve for a term expiring at Homology’s first annual meeting of stockholders held after the effectiveness of the Homology’s Restated Certificate of Incorporation; each director initially assigned to Class II will serve for a term expiring at Homology’s second annual meeting of stockholders held after the effectiveness of the Homology’s Restated Certificate of Incorporation; and each director initially assigned to Class III shall serve for a term expiring at Homology’s third annual meeting of stockholders held after the effectiveness of the Homology’s Restated Certificate of Incorporation. The term of each director will continue until the election and qualification of his or her successor and be subject to his or her earlier death, resignation or removal.    The holders of record of shares of Series B Preferred Stock, exclusively and as a separate class, are entitled to elect two directors of the Q32 board of directors, the holders of record of shares of Series A Preferred Stock, exclusively and as a separate class, are entitled to elect three directors of the Q32 board of directors and the holders of record of shares of Common Stock, exclusively and as a separate class, are entitled to elect one director of the Q32 board of directors. If the holders of shares of Preferred Stock or Common Stock, as the case may be, fail to elect a sufficient number of directors to fill all directorships for which they are entitled to elect directors, then any directorship not so filled shall remain vacant until such time as the holders of the applicable shares of Preferred Stock or Common Stock, as the case may be, elect a person to fill such directorship. The holders of record of the shares of Common Stock and of any other class or series of voting stock (including the Preferred Stock), exclusively and voting together as a single class on an as-as converted to Common Stock basis, shall be entitled to elect the balance of the total number of directors of Q32. The members of the board of directors serve on the Q32 board of directors until their successors are elected and qualified or until their earlier resignation or removal.
Removal of Directors
Subject to the rights of the holders of any series of Homology preferred stock, or except as otherwise provided by the DGCL, the Homology board of directors or any individual director may be removed from office but only for cause and only by the affirmative vote of the holders of at least two-thirds in voting power of the outstanding shares of capital stock of Homology entitled to vote at an election of directors.    Subject to the special rights of the holders of one or more series of Q32 preferred stock to elect directors, or except as otherwise provided by the DGCL or the Q32 Second Amended and Restated Certificate of Incorporation, the Q32 board of directors or any individual director may be removed from office at any time, with or without cause, by the holders of a majority of shares entitled to vote at an election of directors, provided that (i) such removal is directed or approved by the affirmative vote of the person or groups with the right to designate the applicable

 

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   directors, or (ii) the person or groups originally entitled to designate or approve such director is no longer so entitled to designate or approve such director.
Vacancies on the Board of Directors
Subject to the rights of holders of any series of Homology preferred stock, any vacancy or newly created directorship in the Homology board of directors will be filled only by vote of a majority of the directors then in office, although less than a quorum, or by a sole remaining director and will not be filled by the stockholders, unless the Homology board of directors determines by resolution that any such vacancy or newly created directorship will be filled by the stockholders. A director elected to fill a vacancy will hold office until the next election of the class for which such director has been chosen, subject to the election and qualification of a successor and to such director’s earlier death, resignation or removal.    Any director may resign at any time upon notice in writing or electronic transmission to Q32. Such resignation is effective upon Q32’s receipt unless it is specified to be effective at some other time or upon the happening of some other event. Subject to any limitations imposed by applicable law and subject to the rights of the holders of any series of Q32 preferred stock, any vacancies resulting from, resignation, removal or other causes and any newly created directorships resulting from any increase in the number of directors, will, unless the Q32 board of directors determines by resolution that any such vacancies or newly created directorships will be filled by the stockholders and except as otherwise provided by applicable law, be filled only by the affirmative vote of a majority of the directors then in office, even though less than a quorum, or by a sole remaining director, and not by the stockholders.
Stockholder Action by Written Consent
No action that is required or permitted to be taken by the stockholders of Homology at any annual or special meeting of stockholders may be effected by written consent of stockholders in lieu of a meeting.    Action may be taken by the stockholders at an annual or special meeting of stockholders called in accordance with Q32’s Bylaws, or by the written consent or electronic transmission of the Q32 stockholders entitled to vote thereon.
Quorum
Unless otherwise provided by law, Homology’s Restated Certificate of Incorporation or Homology’s Amended and Restated Bylaws, the holders of a majority in voting power of the capital stock issued and outstanding and entitled to vote, present in person, or by remote communication, if applicable, or represented by proxy, will constitute a quorum for the transaction of business at all meetings of the stockholders. If a quorum is not present or represented at any meeting of the stockholders, then either (a) the chairperson of the meeting or (b) a majority in voting power of the stockholders entitled to vote thereon, present in person, or by remote communication, if applicable, or represented by proxy, will have power to adjourn the meeting from time to time until a quorum is present or represented. At such adjourned meeting at which a    Unless otherwise provided by law, Q32’s Second Amended and Restated Certificate of Incorporation, or Q32’s Bylaws, at each meeting of stockholders, the holders of a majority in interest of all stock issued, outstanding and entitled to vote at the meeting, present in person, by remote communication, if applicable, or represented by proxy, will constitute a quorum for the transaction of business. Any meeting may be adjourned from time to time by a majority of the votes properly cast upon the question, whether or not a quorum is present.

 

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quorum is present or represented, any business may be transacted that might have been transacted at the meeting as originally noticed.   
Special Meetings of Stockholders
Special meetings of stockholders for any purpose or purposes may be called at any time only by the Homology board of directors, the chairperson of the Homology board of directors, the chief executive officer or the president (in the absence of a chief executive officer) of Homology. The Homology board of directors will determine the time and place, if any, of such special meeting. Special meetings may not be called by any other person or persons.    Special meetings of stockholders for any purpose or purposes may be called at any time by the Chief Executive Officer, if one is elected, or, if there is no Chief Executive Officer, a President, or by the Board of Directors. The call for the meeting will state the time and place, date, hour and purpose of such meeting. Special meetings may not be called by any other person or persons. Only the purposes specified in the notice of special meeting shall be considered or dealt with at such special meeting.
Notice of Stockholder Meetings
Notice of all meetings of stockholders is to be given in writing or by electronic transmission in the manner provided by law and Homology’s Amended and Restated Bylaws, stating the place, if any, date and hour, of the meeting, and, in the case of a special meeting, the purpose or purposes of the meeting, the record date for determining the stockholders entitled to vote at the meeting (if such date is different from the record date for stockholders entitled to notice of the meeting), and the means of remote communications, if any, by which stockholders and proxy holders may be deemed to be present in person and vote at any such meeting. Unless otherwise required by applicable law, such notice is to be given not less than ten (10) nor more than sixty (60) days before the date of the meeting to each stockholder of record entitled to vote at such meeting.    Notice of all meetings of stockholders is to be given in writing or by electronic transmission in the manner provided by law and Q32’s Bylaws, stating the place, if any, date and hour of the meeting, the means of remote communications, if any, by which stockholders and proxyholders may be deemed to be present and vote at such meeting, and, in the case of a special meeting, the purpose or purposes of the meeting, shall be given by the Secretary (or other person authorized by Q32’s Bylaws or by law) not less than ten (10) nor more than sixty (60) days before the meeting to each stockholder entitled to vote thereat and to each stockholder who, under Q32’s Second Amended and Restated Certificate of Incorporation or under bylaws is entitled to such notice.
Advance Notice Requirements for Stockholder Proposals
Nominations of persons for election to the Homology board of directors and the proposal of business other than nominations to be considered by the stockholders may be made at an annual meeting of stockholders only (i) by or at the direction of the Homology board of directors or any committee thereof, or (ii) by any stockholder of Homology who is a stockholder of record at the time the written notice provided is delivered to the Corporate Secretary of Homology, who is entitled to vote at the meeting and who complies with the notice procedures set forth in Homology’s Amended and Restated Bylaws. For the avoidance of doubt, the foregoing clause (ii) is the exclusive means for a stockholder to make director nominations and submit    Nominations of persons for election to the Q32 board of directors to be considered by the stockholders may be made at an annual meeting of stockholders only (i) pursuant to Q32’s notice of such meeting, (ii) by or at the direction of the Q32 board of directors or (iii) by any stockholder of Q32 who is a stockholder of record at the time the notice provided is delivered to Q32, who is entitled to vote at the meeting and who complies with the notice procedures set forth in Q32’s Bylaws.

 

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other business (other than matters properly included in the corporation’s notice of meeting of stockholders and proxy statement under Rule 14a-8 under the Exchange Act) before an annual meeting of stockholders.   
Amendment of Restated Certificate of Incorporation

The affirmative vote of holders of at least two-thirds in voting power of the outstanding shares of capital stock of Homology entitled to vote thereon will be required to amend certain provisions of Homology’s Restated Certificate of Incorporation, including removal of directors, actions by written consent, and forum selection.

 

Notwithstanding any other provisions of Homology’s Restated Certificate of Incorporation, Homology’s Amended and Restated Bylaws, or any provision of law which might otherwise permit a lesser vote or no vote, stockholders may vote to amend Homology’s Restated Certificate of Incorporation pursuant to Section 242 of the DGCL.

   The affirmative vote of holders of at least a majority of the outstanding shares of Series B Preferred Stock, voting together as a separate class, will be required to amend certain provisions of Q32’s Second Amended and Restated Certificate of Incorporation, in a manner that adversely affects the Series B Preferred Stock. The affirmative vote of holders of at least a majority of the outstanding shares of Series A Preferred Stock, voting together as a separate class, will be required to amend certain provisions of Q32’s Second Amended and Restated Certificate of Incorporation, in a manner that adversely affects the Series A Preferred Stock. The affirmative vote of holders of at least a majority of the outstanding shares of Series A1 Preferred Stock, voting together as a separate class, will be required to amend certain provisions of Q32’s Second Amended and Restated Certificate of Incorporation, in a manner that adversely affects the Series A1 Preferred Stock. The affirmative vote of the holders representing the Required Vote, will be required to amend Q32’s Second Amended and Restated Certificate of Incorporation, including provisions relating to increasing the authorized capital stock and authorizing the creation of additional series of capital stock. Notwithstanding any other provisions of Q32’s Second Amended and Restated Certificate of Incorporation, Q32’s Bylaws, or any provision of law which might otherwise permit a lesser vote or no vote, stockholders may vote to amend Q32’s Second Amended and Restated Certificate of Incorporation pursuant to Section 242 of the DGCL.
Amendment of Bylaws
The affirmative vote of holders of at least two-thirds in voting power of the outstanding shares of capital stock of Homology is required to amend or repeal Homology’s Amended and Restated Bylaws. The Homology board of directors also has the power to adopt, amend or repeal Homology’s Amended and Restated Bylaws by the approval of a majority of the authorized number of directors.    Stockholders or board of directors of Q32 may alter, amend or repeal Q32’s Bylaws; provided, (a) the board of directors may not alter, amend or repeal any provision of Q32’s Bylaws which by law, by Q32’s Second Amended and Restated Certificate of Incorporation or by Q32’s Bylaws requires action by the stockholders and (b) any alteration, amendment or repeal of Q32’s Bylaws by the board of directors and any new by-law adopted by the board of directors may be altered, amended or repealed by the

 

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   stockholders. The affirmative vote of the holders representing the Required Vote, is required to amend Q32’s Bylaws. The affirmative vote of holders of at least a majority of the outstanding shares of Series B Preferred Stock, voting together as a separate class, will be required to amend certain provisions of Q32’s Bylaws, in a manner that adversely affects the Series B Preferred Stock. The affirmative vote of holders of at least a majority of the outstanding shares of Series A Preferred Stock, voting together as a separate class, will be required to amend certain provisions of Q32’s Bylaws, in a manner that adversely affects the Series A Preferred Stock. The affirmative vote of holders of at least a majority of the outstanding shares of Series A1 Preferred Stock, voting together as a separate class, will be required to amend certain provisions of Q32’s Bylaws, in a manner that adversely affects the Series A1 Preferred Stock.
Limitation on Director Liability
The liability of the Homology directors for monetary damages is and will be eliminated to the fullest extent under applicable law. If applicable law is amended to authorize corporate action further eliminating or limiting the personal liability of directors, then the liability of a director to Homology will be eliminated or limited to the fullest extent permitted by applicable law as so amended.    The liability of the Q32 directors for monetary damages is and will be eliminated to the fullest extent under applicable law. If applicable law is amended to authorize corporate action further eliminating or limiting the personal liability of directors, then the liability of a director to Q32 will be eliminated or limited to the fullest extent permitted by applicable law as so amended.
Indemnification
To the fullest extent permitted by applicable law, Homology’s is authorized to provide indemnification of (and advancement of expenses to) directors and officers and agents of Homology (and any other persons to which applicable law permits Homology to provide indemnification) through provisions of Homology’s Amended and Restated Bylaws, agreements with such agents or other persons, vote of stockholders or disinterested directors or otherwise in excess of the indemnification and advancement otherwise permitted by such applicable law. If applicable law is amended to authorize corporate action further eliminating or limiting the personal liability of directors, then the liability of a director to Homology will be eliminated or limited to the fullest extent permitted by applicable law as so amended    To the fullest extent permitted by applicable law, Q32 is authorized to provide indemnification of (and advancement of expenses to) directors, officers and agents of Q32 (and any other persons to which applicable law permits Q32 to provide indemnification) through provisions of Q32’s Bylaws, agreements with such agents or other persons, vote of stockholders or disinterested directors or otherwise in excess of the indemnification and advancement otherwise permitted by such applicable law. If applicable law is amended to authorize corporate action further eliminating or limiting the personal liability of directors, then the liability of a director to Q32 will be eliminated or limited to the fullest extent permitted by applicable law as so amended.
Conversion Rights
Homology does not have any outstanding shares of preferred stock.    Q32’s Second Amended and Restated Certificate of Incorporation provides that holders of Q32 preferred

 

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   stock have the right to convert such shares into shares of common stock at any time at a conversion rate in accordance with the terms of Q32’s Second Amended and Restated Certificate of Incorporation. In addition, upon the closing of the sale of shares of common stock in a firm-commitment underwritten public offering which results in at least $50 million of proceeds or upon the affirmative election of the holders representing the Required Vote, all outstanding shares of preferred stock will be converted into shares of common stock and such shares may not be reissued by Q32.
Right of First Refusal
Homology does not have a right of first refusal in place.    Pursuant to the Amended and Restated Right of First Refusal and Co-Sale Agreement dated August 31, 2020, or the Right of First Refusal Agreement, certain stockholders party to the Right of First Refusal Agreement, or a Key Holder, wishing to transfer any shares of Q32 Common Stock must first provide Q32 with the right to purchase such shares. In such an event, if Q32 does not elect to exercise its right of first refusal in full, any holder of preferred stock that is party to the Right of First Refusal Agreement, or a Q32 Investor, has a secondary refusal right to purchase all or any portion of the shares of Q32 Common Stock which are proposed for sale or transfer by the Key Holders.
Right of Co-Sale
Homology does not have a right of co-sale in place.    Pursuant to the Right of First Refusal Agreement, each Q32 Investor has a right of co-sale with respect to any Q32 Common Stock proposed to be transferred or sold by any Key Holder which is not earlier purchased by Q32 by exercise of its right of first refusal (as further described above) or by any Q32 Investor by exercise of their secondary right of first refusal (as further described above).
Preemptive Rights
Homology stockholders do not have pre-emptive rights. Thus, if additional shares of Homology common stock are issued, the current holders of Homology common stock will own a proportionately smaller interest in a larger number of outstanding shares of common stock to the extent that they do not participate in the additional issuance.    Pursuant to the Second Amended and Restated Investors’ Rights Agreement, dated August 31, 2020, or the IRA, if Q32 proposes to offer or sell new equity securities, Q32 shall first offer such securities to certain holders of Q32 preferred stock, or the Q32 Investors. Each of the Q32 Investors will then have the right to purchase securities in such new offering equal to the proportion of the ownership interest of such Q32 Investor prior to such offering.

 

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Distributions to Stockholders
Dividends upon Homology capital stock, subject to the provisions of Homology’s Restated Certificate of Incorporation and applicable law, if any, may be declared by the Homology board of directors pursuant to law at any regular or special meeting. Dividends may be paid in cash, in property, or in shares of the capital stock, subject to the provisions of Homology’s Restated Certificate of Incorporation and applicable law.    Dividends upon Q32 capital stock, subject to the provisions of Q32’s Second Amended and Restated Certificate of Incorporation and applicable law, if any, may be declared by the Q32 board of directors pursuant to law at any regular or special meeting. Dividends may be paid in cash, in property, or in shares of the capital stock, subject to the provisions of Q32’s amended and restated certificate of incorporation and applicable law. The Q32 board of directors may fix a record date for the determination of holders of Q32 common stock entitled to receive payment of a dividend or distribution declared thereon, which record date is not to precede the date upon which the resolution fixing the record date is adopted, and which record date may not be more than 60 days nor less than 10 days prior to the date fixed for the payment thereof.
Exclusive Forum
Unless Homology consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for (i) any derivative action or proceeding brought on behalf of Homology; (ii) any action asserting a claim of breach of a fiduciary duty owed by any director, officer, employee or stockholder of Homology to Homology or Homology stockholders; (iii) any action asserting a claim against Homology arising pursuant to any provision of the DGCL, Homology’s Restated Certificate of Incorporation or Homology’s Amended and Restated Bylaws; or (iv) any action asserting a claim against Homology governed by the internal affairs doctrine. The federal district courts of the United States will be the exclusive forum for the resolution of any complaint asserting a cause of action under the Securities Act. Any person or entity purchasing or otherwise acquiring any interest in shares of capital stock of Homology will be deemed to have notice of and to have consented to the forum selection provision of Homology’s Restated Certificate of Incorporation.    Unless Q32 consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for (i) any derivative action or proceeding brought on behalf of Q32; (ii) any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee of Q32 to Q32 or Q32’s stockholders; (iii) any action asserting a claim against Q32 arising pursuant to any provision of the DGCL, Q32’s Second Amended and Restated Certificate of Incorporation or Q32’s Bylaws; or (iv) any action asserting a claim against Q32 governed by the internal affairs doctrine. Any person or entity purchasing or otherwise acquiring any interest in shares of capital stock of Q32 will be deemed to have notice of and to have consented to the forum selection provision of Q32’s Second Amended and Restated Certificate of Incorporation.
Registration Rights
See “Certain Related Person Transactions of Homology” in this proxy statement/prospectus.    Under the IRA, certain holders of Q32 preferred stock that are party to the IRA have certain registration rights, including the right to demand that Q32 file a registration statement, so called “demand” registration rights, or request that their shares be covered by a registration statement that Q32 is otherwise filing, so-called “piggyback” registration rights.

 

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Stock Transfer Restrictions Applicable to Stockholders
Shares of Homology are transferable in the manner prescribed by law and Homology’s Amended and Restated Bylaws.    Shares of Q32 are transferable in the manner prescribed by the DGCL.

 

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PRINCIPAL STOCKHOLDERS OF HOMOLOGY

The following table sets forth information relating to the beneficial ownership of Homology common stock as of November 30, 2023, by (i) each person, or group of affiliated persons, known by Homology to beneficially own more than 5% of Homology’s outstanding shares of common stock; (ii) each of its directors; (iii) each of its named executive officers; and (iv) all directors and executive officers as a group.

The number of shares beneficially owned by each stockholder is determined under rules issued by the SEC. Under these rules, a person is deemed to be a “beneficial” owner of a security if that person has or shares voting power or investment power, which includes the power to dispose of or to direct the disposition of such security. Except as indicated in the footnotes below, Homology believes, based on the information furnished and information filed with the SEC, that the individuals and entities named in the table below have sole voting and investment power with respect to all shares of common stock beneficially owned by them, subject to any applicable community property laws.

The percentage of shares beneficially owned is computed on the basis of 58,017,412 shares of Homology common stock outstanding as of November 30, 2023. Shares of Homology common stock that a person has the right to acquire within 60 days of November 30, 2023 are deemed outstanding for purposes of computing the percentage ownership of the person holding such rights, but are not deemed outstanding for purposes of computing the percentage ownership of any other person, except with respect to the percentage ownership of all directors and executive officers as a group. Unless otherwise indicated, the address for each of the stockholders in the table below is c/o Homology Medicines, Inc., One Patriots Park, Bedford, MA 01730.

 

     Beneficial Ownership
Prior to this Offering
 
Name of Beneficial Owner    Number      Percent  

5% or Greater Stockholders

     

Entities affiliated with ARCH Venture Fund (1)

     5,768,694        9.9 % 

TLS Beta Pte. Ltd. (2)

     5,650,996        9.7 % 

Pfizer Inc. (3)

     5,000,000        8.6 % 

Entities affiliated with 5AM Ventures (4)

     4,535,919        7.8 % 

Named Executive Officers and Directors

     

Albert Seymour (5)

     825,437        1.4 % 

W. Bradford Smith (6)

     643,510        1.1 % 

Paul Alloway, Ph.D. (7)

     297,649        *  

Steven Gillis, Ph.D. (1)(8)

     5,869,434        10.1 % 

Matthew R. Patterson (9)

     101,690        *  

Jeffrey V. Poulton (10)

     72,000        *  

Alise S. Reicin, M.D. (11)

     85,160        *  

Mary Thistle (12)

     100,740        *  

Arthur O. Tzianabos, Ph.D. (13)

     2,137,479        3.6 % 

All executive officers and directors as a group (8 persons) (14)

     8,729,103        14.4 % 

 

*

Represents beneficial ownership of less than 1%.

(1)

Based on a Schedule 13G/A filed with the SEC on February 13, 2020 and Homology’s records. Consists of 4,631,031 shares of common stock held by ARCH Venture Fund VIII, L.P. (“ARCH Fund VIII”) and 1,137,663 shares of common stock held by ARCH Venture Fund VIII Overage, L.P. (“ARCH Fund Overage”). The sole general partner of ARCH Fund VIII is ARCH Venture Partners VIII, L.P. (“ARCH Partners VIII”), which may be deemed to beneficially own the shares held by ARCH Fund VIII. The sole general partner of ARCH Partners VIII and ARCH Fund Overage is ARCH Venture Partners VIII, LLC (“ARCH VIII LLC”), which has shared voting and dispositive power over the shares of common stock held by each of ARCH Fund VIII and ARCH Fund Overage. ARCH Partners VIII and ARCH VIII LLC disclaim beneficial ownership of such shares, except to the extent of any pecuniary interest therein. The managing directors of ARCH VIII LLC are Keith L. Crandell, Clinton Bybee and Robert Nelsen, and they may be deemed to have shared voting and dispositive power over the

 

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  shares of common stock held by ARCH Fund VIII and ARCH Fund Overage. Messrs. Crandell, Bybee and Nelsen disclaim beneficial ownership of such shares, except to the extent of any pecuniary interest therein. Steven Gillis, M.D., Ph.D., one of our directors, is a managing director at ARCH Venture Partners. Director Steven Gillis owns an interest in ARCH Partners VIII but does not have voting or investment control over the shares held by ARCH Fund VIII, and disclaims beneficial ownership of such shares, except to the extent of any pecuniary interest therein. The address of ARCH Fund VIII and ARCH Fund Overage is 8755 West Higgins Road, Suite 1025, Chicago, Illinois 60631.
(2)

Based on a Schedule 13G/A filed with the SEC on February 14, 2022, Temasek Holdings (Private) Limited, Fullerton Management Pte Ltd and Temasek Life Sciences Private Limited each has shared voting and dispositive power over 5,650,996 shares of common stock, V- Sciences Investments Pte Ltd has shared voting and dispositive power over 3,055,703 shares of common stock, and TLS Beta Pte. Ltd. has shared voting and dispositive power over 2,595,293 shares of common stock. The principal business address of Temasek Holdings (Private) Limited, Fullerton Management Pte Ltd, Temasek Life Sciences Private Limited, V-Sciences Investments Pte Ltd and TLS Beta Pte. Ltd. is 60B Orchard Road #06-18 Tower 2, The Atrium@Orchard, Singapore 238891.

(3)

Based on a Schedule 13G filed with the SEC on November 19, 2020, Pfizer Inc. has sole voting and dispositive power over all 5,000,000 shares. The address of Pfizer Inc. is 235 East 42nd Street, New York, NY 10017.

(4)

Based on a Schedule 13G/A filed with the SEC on February 16, 2021 and Homology’s records. Consists of 4,354,484 shares of common stock held by 5AM Ventures IV, L.P. (“Ventures IV”), as to which Ventures IV has shared voting and dispositive power, and 181,435 shares of common stock held by 5AM Co-Investors IV, L.P. (“Co-Investors IV”), as to which Co-Investors IV has shared voting and dispositive power. 5AM Partners IV, LLC (“Partners IV”) is the sole general partner of Ventures IV and Co-Investors IV. Dr. John Diekman, Andrew J. Schwab and Dr. Scott M. Rocklage, are the managing members of Partners IV and, along with Partners IV, have shared voting and investment power over the shares beneficially owned by Ventures IV and Co-Investors IV. Kush M. Parmar, M.D., Ph.D., one of our directors, is an affiliate of Ventures IV. Each of Partners IV, Dr. Diekman, Mr. Schwab and Dr. Rocklage disclaim beneficial ownership of such shares except to the extent of its or their recurring interest therein. The address of all entities affiliated with 5AM Ventures is 501 2nd Street, Suite 350, San Francisco, CA 94107.

(5)

Includes options to purchase 641,333 shares of common stock that are or will be immediately exercisable by Dr. Seymour within 60 days of November 30, 2023 and 5,545 restricted stock units that will vest within 60 days of November 30, 2023.

(6)

Includes options to purchase 609,861 shares of common stock that are or will be immediately exercisable by Mr. Smith within 60 days of November 30, 2023 and 3,087 restricted stock units that will vest within 60 days of November 30, 2023.

(7)

Includes options to purchase 262,333 shares of common stock that are or will be immediately exercisable by Dr. Alloway within 60 days of November 30, 2023 and 18,610 restricted stock units that will vest within 60 days of November 30, 2023.

(8)

Includes options to purchase 100,740 shares of common stock that are or will be immediately exercisable by Dr. Gillis within 60 days of November 30, 2023.

(9)

Consists of options to purchase 101,690 shares of common stock that are or will be immediately exercisable by Mr. Patterson within 60 days of November 30, 2023.

(10)

Consists of options to purchase 72,000 shares of common stock that are or will be immediately exercisable by Mr. Poulton within 60 days of November 30, 2023.

(11)

Consists of options to purchase 85,160 shares of common stock that are or will be immediately exercisable by Dr. Reicin within 60 days of November 30, 2023.

(12)

Consists of options to purchase 100,740 shares of common stock that are or will be immediately exercisable by Ms. Thistle within 60 days of November 30, 2023.

(13)

Includes options to purchase 1,995,664 shares of common stock that are or will be immediately exercisable by Dr. Tzianabos within 60 days of November 30, 2023 and 33,420 restricted stock units that will vest within 60 days of November 30, 2023.

(14)

Includes options to purchase 2,769,972 shares of common stock that are or will be immediately exercisable within 60 days of November 30, 2023 and 56,270 restricted stock units that will vest within 60 days of November 30, 2023.

 

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PRINCIPAL STOCKHOLDERS OF Q32

The following table and accompanying footnotes set forth certain information with respect to the beneficial ownership of Q32 common stock as of November 30, 2023 for:

 

  •  

each of Q32’s directors;

 

  •  

each of Q32’s named executive officers;

 

  •  

all of Q32’s directors and executive officers as a group; and

 

  •  

each person, or group of affiliated persons, who beneficially owned more than 5% of Q32’s outstanding shares of common stock.

Q32 has determined beneficial ownership in accordance with the rules of the Securities and Exchange Commission, and the information is not necessarily indicative of beneficial ownership for any other purpose. Except as indicated by the footnotes below, Q32 believes, based on information furnished to it, that the persons and entities named in the table below have sole voting and sole investment power with respect to all shares of common stock that they beneficially owned, subject to applicable community property laws.

Beneficial ownership prior to the completion of the Merger is based on 116,092,897 shares of Q32 common stock outstanding as of November 30, 2023, after giving effect to the conversion of all outstanding shares of Q32’s Preferred Stock (including warrants convertible into 377,899 shares of Q32 common stock) into an aggregate of 109,196,314 shares of Q32 common stock and without giving effect to any purchases in the Pre-Closing Financing or conversion of the Convertible Notes.

In computing the number of shares of common stock beneficially owned by a person and the percentage ownership of that person, Q32 deemed to be outstanding all shares of common stock subject to options held by that person or entity that are currently exercisable or that will become exercisable within 60 days of November 30, 2023. Q32 did not deem these shares outstanding, however, for the purpose of computing the percentage ownership of any other person. Unless otherwise indicated, the address of each beneficial owner listed in the table below is c/o Q32, Bio Inc., 830 Winter St., Waltham, MA 02451.

 

     Beneficial Ownership
Prior to the Merger
 
Name of Beneficial Owner    Number      Percent  

5% or Greater Stockholders:

     

OrbiMed Private Investments VII, LP (1)

     30,672,408        26.42 % 

Entities affiliated with Atlas Venture (2)

     28,482,180        24.53 % 

Abingworth Bioventures VII LP (3)

     15,013,216        12.93 % 

Acorn Bioventures, L.P. (4)

     10,937,926        9.42 % 

Osage University Partners III, LP (5)

     7,291,951        6.28 % 

Bristol-Myers Squibb Company (6)

     6,628.788        5.71 % 

Directors and Named Executive Officers:

     

Jason A. Campagna (7)

     1,451,020        1.14 % 

Jodie Morrison (8)

     2,002,346        1.70 % 

Michael Broxson (9)

     2,745,541        2.36 % 

Adam Cutler (10)

     1,098,820        *  

Bill Lundberg (11)

     241,875        *  

Kathleen LaPorte (12)

     274,812        *  

Mark Iwicki (13)

     660,731        *  

Jayson Punwani

     —          —    

David Grayzel (14)

     28,482,180        24.53 % 

Isaac Manke

     —          —    

Diyong Xu (15)

    
30,672,408
 
     26.42 % 

All executive officers and directors as a group (11 persons) (16)

     41,854,605        36.05 % 

 

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*

Represents beneficial ownership of less than 1%.

(1)

Consists of (i) 17,000,000 shares of Q32 common stock issuable upon conversion of Q32 Series A preferred stock held by OrbiMed Private Investments VII, LP, or OPI VII, and (ii) 13,672,408 shares of Q32 common stock issuable upon conversion of Q32 Series B preferred stock held by OPI VII. OrbiMed Capital VII LLC, or GP VII, is the general partner of OPI VII. OrbiMed Advisors LLC, or OrbiMed Advisors, is the managing member of GP VII. By virtue of such relationships, GP VII and OrbiMed Advisors may be deemed to have beneficial ownership over such shares. OrbiMed Advisors exercises investment and voting power through a management committee comprised of Carl L. Gordon, Sven H. Borho, and W. Carter Neild. Diyong Xu, a member of Q32’s board of directors, is an employee of OrbiMed Advisors. Each of Dr. Gordon and Messrs. Borho, Neild, and Xu disclaim beneficial ownership of the shares held by OPI VII. The address for the OrbiMed entities is c/o OrbiMed Advisors LLC, 601 Lexington Avenue, 54th Floor, New York, NY 10022.

(2)

Consists of (i) 800,000 shares of Q32 common stock held by Atlas Venture Fund X, L.P., or Atlas Venture X, (ii) 5,200,000 shares of Q32 common stock issuable upon conversion of Q32 Series A1 preferred stock held by Atlas X, (iii) 12,000,000 shares of Q32 common stock issuable upon conversion of Q32 Series A preferred stock held by Atlas X, and (iv) 10,482,180 shares of Q32 common stock issuable upon conversion of Q32 Series B preferred stock held by Atlas Venture Opportunity Fund I, L.P., or Atlas Opportunity I. The general partner of Atlas X is Atlas Venture Associates X, L.P., or AVA X, and the general partner of AVA X is Atlas Ventures Associates X, LLC, or AVA X LLC. The general partner of Atlas Opportunity I is Atlas Venture Associates Opportunity I, L.P., or AVAO I, and the general partner of AVAO I is Atlas Venture Associates Opportunity I, LLC, or AVAO I LLC. David Grayzel is a member of AVA X LLC and AVAO I LLC, and is a member of Q32’s board of directors. Each of AVA X, AVA X LLC, AVAO I, AVAO I LLC, and Mr. Grayzel may be deemed to beneficially own the shares held by Atlas X and Atlas Opportunity I. Each of AVA X, AVA X LLC, AVAO I, AVAO I LLC, and Mr. Grayzel expressly disclaim beneficial ownership of the securities owned by Atlas X and Atlas Opportunity I, except to the extent of its pecuniary interest therein, if any. The address for Atlas X, AVA X, AVA X LLC, Atlas Venture Opportunity I, AVAO I, and AVAO I LLC is 300 Technology Sq., 8th Floor, Cambridge, MA 02139.

(3)

Consists of (i) 10,000,000 shares of Q32 common stock issuable upon conversion of Q32 Series A preferred stock held by Abingworth Bioventures VII LP, or ABV VII, and (ii) 5,013,216 shares of Q32 common stock issuable upon conversion of Q32 Series B preferred stock held by ABV VII. The Carlyle Group Inc., which is a publicly traded entity listed on Nasdaq, is the sole shareholder of Carlyle Holdings I GP Inc., which is the sole member of Carlyle Holdings I GP Sub L.L.C., which is the general partner of Carlyle Holdings I L.P., which, with respect to the securities reported herein, is the managing member of CG Subsidiary Holdings L.L.C., which is the managing member of TC Group, L.L.C., which is the managing member of Carlyle Investment Management, L.L.C., which is the sole member of Carlyle Genesis UK LLC. Carlyle Genesis UK LLC is the principal member of Abingworth LLP. ABV VII has delegated to Abingworth LLP all investment and dispositive power over the securities held of record by ABV VII. As a result, each of the foregoing entities may be deemed to share beneficial ownership of the securities held of record by ABV VII, but each disclaims such beneficial ownership. Voting and investment determinations with respect to the securities held by ABV VII are made by an investment committee of Abingworth LLP, which is comprised of Timothy Haines, Kurt von Emster, Bali Muralidhar and Andrew Sinclair. Each member of the investment committee disclaims beneficial ownership of the securities beneficially held by ABV VII. The address for each of the Carlyle entities is c/o The Carlyle Group, 1001 Pennsylvania Ave. NW, Suite 220 South, Washington, DC 20004-2505. The address for each of Abingworth LLP and ABV VII is c/o Abingworth LLP, 38 Jermyn Street, London, England SW1Y 6DN..

(4)

Consists of 10,937,926 shares of Q32 common stock issuable upon conversion of Q32 Series B preferred stock held by Acorn Bioventures, L.P., or Acorn. The general partner of Acorn is Acorn Capital Advisors GP, LLC. Isaac Manke is a General Partner at Acorn and a member of Q32’s board of directors. The address for Acorn and Acorn Capital Advisors GP, LLC is 410 Lexington Ave, Suite 2626, New York, NY 10170.

(5)

Consists of 7,291,951 shares of Q32 common stock issuable upon conversion of Q32 Series B preferred stock held by Osage University Partners III, LP, or Osage. The general partner of Osage is Osage University

 

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  GP III, LLC (“OUP GP III”). Robert Adelson, William Harrington and Marc Singer (the “OUP Managers”) are the managers of OUP GP III. OUP GP III and each OUP Manager may be deemed to share voting, investment and dispositive power over the shares held by OUP III and as a result may be deemed to have beneficial ownership over such securities. OUP GP III and each OUP Manager disclaims beneficial ownership over the securities held by OUP III, except to the extent of their respective pecuniary interests therein. The address of the principal business office of Osage University Partners III, L.P. is 50 Monument Road, Suite 201, Bala Cynwyd, PA 19004.
(6)

Consists of 6,628,788 shares of Q32 common stock issuable upon conversion of Q32 Series A preferred stock held by Bristol-Myers Squibb Company, or BMS. The address for BMS is Route 206 & Province Line Road, Princeton, NJ 08543-4000.

(7)

Consists of 1,451,020 shares of Q32 common stock underlying options which are exercisable or will become exercisable within 60 days of November 30, 2023.

(8)

Consists of 2,002,346 shares of Q32 common stock underlying options which are exercisable or will become exercisable within 60 days of November 30, 2023.

(9)

Consists of 2,745,541 shares of Q32 common stock underlying options which are exercisable or will become exercisable within 60 days of November 30, 2023. Mr. Broxson separated from Q32 on September 30, 2022.

(10)

Consists of 1,098,820 shares of Q32 common stock underlying options which are exercisable or will become exercisable within 60 days of November 30, 2023. Mr. Cutler resigned as Q32’s Chief Financial Officer in October 2023.

(11)

Consists of (i) 25,000 shares of Q32 common stock held by Mr. Lundberg, and (ii) 216,875 shares of Q32 common stock underlying options which are exercisable or will become exercisable within 60 days of November 30, 2023.

(12)

Consists of (i) 113,124 shares of Q32 common stock held by The Kathleen D. LaPorte Revocable Trust, or the LaPorte Trust, and (ii) 161,688 shares of Q32 common stock underlying options which are exercisable or will become exercisable within 60 days of November 30, 2023. The address of the LaPorte Trust is c/o Kathleen D. LaPorte 30 Quail Ct., Portola Valley CA 94028.

(13)

Consists of 660,731 shares of Q32 common stock underlying options which are exercisable or will become exercisable within 60 days of November 30, 2023.

(14)

Consists of (i) 800,000 shares of Q32 common stock held by Atlas Venture Fund X, L.P., or Atlas Venture X, (ii) 5,200,000 shares of Q32 common stock issuable upon conversion of Q32 Series A1 preferred stock held by Atlas X, (iii) 12,000,000 shares of Q32 common stock issuable upon conversion of Q32 Series A preferred stock held by Atlas X, and (iv) 10,482,180 shares of Q32 common stock issuable upon conversion of Q32 Series B preferred stock held by Atlas Venture Opportunity Fund I, L.P., or Atlas Opportunity I. The general partner of Atlas X is Atlas Venture Associates X, L.P., or AVA X, and the general partner of AVA X is Atlas Ventures Associates X, LLC, or AVA X LLC. The general partner of Atlas Opportunity I is Atlas Venture Associates Opportunity I, L.P., or AVAO I, and the general partner of AVAO I is Atlas Venture Associates Opportunity I, LLC, or AVAO I LLC.. David Grayzel is a member of AVA X LLC and AVAO I LLC, and is a member of Q32’s board of directors. Each of AVA X, AVA X LLC, AVAO I, AVAO I LLC, and Mr. Grayzel may be deemed to beneficially own the shares held by Atlas X and Atlas Opportunity I. Each of AVA X, AVA X LLC, AVAO I, AVAO I LLC, and Mr. Grayzel expressly disclaim beneficial ownership of the securities owned by Atlas X and Atlas Opportunity I, except to the extent of its pecuniary interest therein, if any. The address for Atlas X, AVA X, AVA X LLC, Atlas Venture Opportunity I, AVAO I, and AVAO I LLC is 300 Technology Sq., 8th Floor, Cambridge, MA 02139.

(15)

Consists of (i) 17,000,000 shares of Q32 common stock issuable upon conversion of Q32 Series A preferred stock held by OrbiMed Private Investments VII, LP, or OPI VII, and (ii) 13,672,408 shares of Q32 common stock issuable upon conversion of Q32 Series B preferred stock held by OPI VII. OrbiMed Capital VII LLC, or GP VII, is the general partner of OPI VII. OrbiMed Advisors LLC, or OrbiMed Advisors, is the managing member of GP VII. By virtue of such relationships, GP VII and OrbiMed Advisors may be deemed to have beneficial ownership over such shares. OrbiMed Advisors exercises investment and voting power through a management committee comprised of Carl L. Gordon, Sven H. Borho, and W. Carter Neild. Diyong Xu, a member of Q32’s board of directors, is an employee of OrbiMed Advisors. Each of

 

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  Dr. Gordon and Messrs. Borho, Neild, and Xu disclaim beneficial ownership of the shares held by OPI VII.
  The address for the OrbiMed entities is c/o OrbiMed Advisors LLC, 601 Lexington Avenue, 54th Floor, New York, NY 10022.
(16)

Consists of (i) 1,693,680 shares of Q32 common stock, (ii) 5,200,000 shares of Q32 common stock issuable upon conversion of Q32 Series A1 preferred stock, (iii) 29,000,000 shares of Q32 common stock issuable upon conversion of Q32 Series A preferred stock, (iv) 24,154,588 shares of Q32 common stock issuable upon conversion of Q32 Series B preferred stock, and (v) 5,960,925 shares of Q32 common stock underlying options which are exercisable or will become exercisable within 60 days of November 30, 2023.

 

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PRINCIPAL STOCKHOLDERS OF COMBINED COMPANY

Except where specifically noted, the following information and all other information contained in this proxy statement/prospectus does not give effect to the proposed Reverse Stock Split.

The following table sets forth certain information regarding beneficial ownership of the combined company’s common stock immediately after consummation of the Merger, assuming the consummation of the Merger occurred on November 30, 2023 for: each stockholder expected by Homology and Q32 to become the beneficial owner of more than 5% of the combined company’s outstanding common stock, each person expected to be a named executive officer of the combined company, each person expected to be a director of the combined company, and all of the combined company’s expected directors and executive officers as a group.

Beneficial ownership is determined in accordance with the rules of the SEC and generally includes voting or investment power with respect to securities. Under those rules, beneficial ownership includes any shares as to which the individual or entity has sole or shared voting power or investment power with respect to the securities as well as any shares of common stock that the individual or entity has the right to acquire within 60 days of November 30, 2023 the exercise of stock options or other rights. These shares are deemed to be outstanding and beneficially owned by the person holding those options for the purpose of computing the percentage ownership of that person, but they are not treated as outstanding for the purpose of computing the percentage ownership of any other person. Except as noted by footnote, and subject to community property laws where applicable, Homology and Q32 believe, based on the information provided to them, that the persons and entities named in the table below have sole voting and investment power with respect to all common stock shown as beneficially owned by them.

The table lists applicable percentage ownership based on 216,617,668 shares of common stock of the combined company expected to be outstanding upon consummation of the Merger, after giving effect to the Pre-Closing Financing and prior to giving effect to the proposed Reverse Stock Split. The number of shares beneficially owned includes shares of common stock that each person has the right to acquire within 60 days, including upon the exercise of stock options and the vesting of restricted stock units. These stock options and restricted stock units shall be deemed to be outstanding for the purpose of computing the percentage of outstanding shares of the combined company’s common stock expected to be owned by such person but shall not be deemed to be outstanding for the purpose of computing the percentage of outstanding shares of the combined organization’s common stock expected to be owned by any other person.

Immediately after the Merger, Homology securityholders as of immediately prior to the Merger are expected to own approximately 25% of the outstanding shares of the combined company, former Q32 securityholders, including shares purchased in the Pre-Closing Financing and shares converted in connection with the Convertible Notes, are expected to own approximately 75% of the outstanding shares of the combined company and shares issued in the Pre-Closing Financing are expected to represent approximately 13 % of the outstanding shares of capital stock of the combined company, subject to certain assumptions, including, but not limited to, Homology’s net cash as of the closing date of the Merger being equal to $60.0 million and Q32 issuing approximately $42.0 million of Q32 common stock in the Pre-Closing Financing. The table below assumes that, based on Homology’s and Q32’s capitalization as of November 16, 2023, the date the Merger Agreement was executed, the exchange ratio is estimated to be equal to approximately 0.8800 shares of Homology common stock, prior to giving effect to the proposed Reverse Stock Split. The estimated exchange ratio was derived on a fully-diluted basis as of November 16, 2023 using a stipulated value of Q32 of approximately $237.0 million (including the Pre-Closing Financing) and of Homology of approximately $80.0 million.

 

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    Beneficial Ownership
After the Merger
 
Name of Beneficial Owner   Number     Percent  

5% or Greater Stockholders:

   

OrbiMed Private Investments VII, LP (1)

    41,158,176       19.00 % 

Entities affiliated with Atlas Venture (2)

    38,219,189       17.64 % 

Abingworth Bioventures VII LP (3)

    20,145,582       9.30 % 

Acorn Bioventures, L.P. (4)

    14,677,201       6.78 % 

Bristol-Myers Squibb Company (5)

    13,785,357       6.36 % 

Directors and Named Executive Officers:

   

Jason A. Campagna (6)

    1,176,394       *  

Jodie Morrison (7)

    1,762,064       *  

Mary Thistle (8)

    100,740       *  

Arthur Tzianabos (9)

    2,137,479       *  

Shelia M. Violette (10)

    1,802,074       *  
   
   
   

All executive officers and directors as a group (                 persons) (11)

               % 

 

*

Represents beneficial ownership of less than 1%.

(1)

Consists of 41,158,176 shares of the combined company’s common stock held by OrbiMed Private Investments VII, LP, or OPI VII. OrbiMed Capital VII LLC, or GP VII, is the general partner of OPI VII. OrbiMed Advisors LLC, or OrbiMed Advisors, is the managing member of GP VII. By virtue of such relationships, GP VII and OrbiMed Advisors may be deemed to have beneficial ownership over such shares. OrbiMed Advisors exercises investment and voting power through a management committee comprised of Carl L. Gordon, Sven H. Borho, and W. Carter Neild. Diyong Xu, a member of Q32’s board of directors, is an employee of OrbiMed Advisors. Each of Dr. Gordon and Messrs. Borho, Neild, and Xu disclaim beneficial ownership of the shares held by OPI VII. The address for the OrbiMed entities is c/o OrbiMed Advisors LLC, 601 Lexington Avenue, 54th Floor, New York, NY 10022.

(2)

Consists of (i) 15,840,288 shares of the combined company’s common stock held by Atlas Venture Fund X, L.P., or Atlas X, (ii) 9,224,486 shares of the combined company’s common stock held by Atlas Venture Opportunity Fund I, L.P., or Atlas Opportunity I, and (iii) 13,154,415 shares of the combined company’s common stock held by Atlas Venture Opportunity Fund II, L.P., or Atlas Opportunity II. The general partner of Atlas X is Atlas Venture Associates X, L.P., or AVA X, and the general partner of AVA X is Atlas Ventures Associates X, LLC, or AVA X LLC. The general partner of Atlas Opportunity I is Atlas Venture Associates Opportunity I, L.P., or AVAO I, and the general partner of AVAO I is Atlas Venture Associates Opportunity I, LLC, or AVAO I LLC. The general partner of Atlas Opportunity II is Atlas Venture Associates Opportunity II, L.P., or AVAO II, and the general partner of AVAO II is Atlas Venture Associates Opportunity II, LLC, or AVAO II LLC. David Grayzel is a member of AVA X LLC, AVAO I LLC, and AVAO II LLC, and is a member of Q32’s board of directors. Each of AVA X, AVA X LLC, AVAO I, AVAO I LLC, AVAO II, AVAO II LLC, and Mr. Grayzel may be deemed to beneficially own the shares held by Atlas X, Atlas Opportunity I, and Atlas Opportunity II. Each of AVA X, AVA X LLC, AVAO I, AVAO I LLC, AVAO II, AVAO II LLC, and Mr. Grayzel expressly disclaim beneficial ownership of the securities owned by Atlas X, Atlas Opportunity I, and Atlas Opportunity II, except to the extent of its pecuniary interest therein, if any. The address for Atlas X, AVA X, AVA X LLC, Atlas Opportunity I, AVAO I, AVAO I LLC, Atlas Opportunity II, AVAO II, AVAO II LLC is 300 Technology Sq., 8th Floor, Cambridge, MA 02139.

(3)

Consists of 20,145,582 shares of the combined company’s common stock held by Abingworth Bioventures VII LP, or ABV VII. The Carlyle Group Inc., which is a publicly traded entity listed on Nasdaq, is the sole shareholder of Carlyle Holdings I GP Inc., which is the sole member of Carlyle Holdings I GP Sub L.L.C., which is the general partner of Carlyle Holdings I L.P., which, with respect to the securities reported herein,

 

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  is the managing member of CG Subsidiary Holdings L.L.C., which is the managing member of TC Group, L.L.C., which is the managing member of Carlyle Investment Management, L.L.C., which is the sole member of Carlyle Genesis UK LLC. Carlyle Genesis UK LLC is the principal member of Abingworth LLP. ABV VII has delegated to Abingworth LLP all investment and dispositive power over the securities held of record by ABV VII. As a result, each of the foregoing entities may be deemed to share beneficial ownership of the securities held of record by ABV VII, but each disclaims such beneficial ownership. Voting and investment determinations with respect to the securities held by ABV VII are made by an investment committee of Abingworth LLP, which is comprised of Timothy Haines, Kurt von Emster, Bali Muralidhar and Andrew Sinclair. Each member of the investment committee disclaims beneficial ownership of the securities beneficially held by ABV VII.
(4)

Consists of 14,677,201 shares of the combined company’s common stock held by Acorn Bioventures, L.P., or Acorn. The general partner of Acorn is Acorn Capital Advisors GP, LLC. Isaac Manke is a General Partner at Acorn and a member of Q32’s board of directors. The address for Acorn and Acorn Capital Advisors GP, LLC is 410 Lexington Ave, Suite 2626, New York, NY 10170.

(5)

Consists of 13,785,357 shares of the combined company’s common stock held by Bristol-Myers Squibb Company, or BMS. The address for BMS is Route 206 & Province Line Road, Princeton, NJ 08543-4000.

(6)

Consists of 1,176,394 shares of the combined company’s common stock underlying options which are exercisable or will become exercisable within 60 days of November 30, 2023.

(7)

Consists of 1,762,064 shares of the combined company’s common stock underlying options which are exercisable or will become exercisable within 60 days of November 30, 2023.

(8)

Consists of 100,740 shares of the combined company’s common stock underlying options which are exercisable or will become exercisable within 60 days of November 30, 2023.

(9)

Consists of (i) 1,995,664 shares of the combined company’s common stock underlying options which are exercisable or will become exercisable within 60 days of November 30, 2023, and (i) 33,420 of the combined company’s common stock underlying restricted stock units that will vest within 60 days of November 30, 2023.

(10)

Consists of (i) 664,889 shares of the combined company’s common stock held by Violette Holdings LLC, or Violette Holdings, and (ii) 1,137,185 shares of the combined company’s common stock underlying options which are exercisable or will become exercisable within 60 days of November 30, 2023. The address of Violette Holdings is c/o Shelia Violette, 91 Simonds Road, Lexington, MA 02420.

(11)

Consists of (i)              shares of the combined company’s common stock and (ii)              shares of the combined company’s common stock underlying options which are exercisable or will become exercisable within 60 days of November 30, 2023.

 

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LEGAL MATTERS

Latham & Watkins LLP will pass upon the validity of Homology common stock offered by this proxy statement/prospectus.

EXPERTS

The financial statements of Homology Medicines, Inc. as of December 31, 2022 and 2021, and for each of the two years in the period ended December 31, 2022, included in this proxy statement/prospectus, have been audited by Deloitte & Touche LLP, an independent registered public accounting firm, as stated in their report. Such financial statements are included in reliance upon the report of such firm given their authority as experts in accounting and auditing.

The consolidated financial statements of Q32 Bio, Inc. at December 31, 2022 and 2021, and for each of the two years in the period ended December 31, 2022, included in the Proxy Statement of Homology Medicines, Inc., which is referred to and made a part of this Prospectus and Registration Statement, have been audited by Ernst & Young LLP, independent registered public accounting firm, as set forth in their report (which contains an explanatory paragraph describing conditions that raise substantial doubt about the Company’s ability to continue as a going concern as described in Note 1 to the consolidated financial statements) appearing elsewhere herein, and are included in reliance upon such report given on the authority of such firm as experts in accounting and auditing.

 

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WHERE YOU CAN FIND MORE INFORMATION

Homology is subject to the informational requirements of the Exchange Act and in accordance therewith, files annual, quarterly and current reports, proxy statements and other information with the SEC electronically, and the SEC maintains a website that contains Homology’s filings as well as reports, proxy and information statements, and other information issuers file electronically with the SEC at www.sec.gov.

Homology also makes available free of charge on or through its website at www.homologymedicines.com, its Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after Homology electronically files such material with or otherwise furnishes it to the SEC. The website addresses for the SEC and Homology are inactive textual references and except as specifically incorporated by reference into this proxy statement/prospectus, information on those websites is not part of this proxy statement/prospectus.

Homology has filed with the SEC a registration statement on Form S-4, of which this proxy statement/prospectus is a part, under the Securities Act to register the shares of Homology common stock to be issued to Q32 stockholders in the Merger. The registration statement, including the attached annexes, exhibits and schedules, contains additional relevant information about Homology and Homology common stock. This proxy statement/prospectus does not contain all of the information set forth in the registration statement because certain parts of the registration statement are omitted in accordance with the rules and regulations of the SEC.

Homology has supplied all information contained in this proxy statement/prospectus relating to Homology and Q32 has supplied all information contained in this proxy statement/prospectus relating to Q32.

If you would like to request documents from Homology or Q32, please send a request in writing or by telephone to either Homology or Q32 at the following addresses:

 

Homology Medicines, Inc.

One Patriots Park

Bedford, MA 01730

(781) 327-2633

Attn: Corporate Secretary

Email: IR@homologymedicines.com

 

Q32 Bio Inc.

830 Winter Street

Waltham, MA 02451

Attn: Investor Relations

(781) 999-0232

Email: IR@q32bio.com

If you are a Homology stockholder and would like additional copies, without charge, of this proxy statement/prospectus or if you have questions about the Merger, including the procedures for voting your shares, you should contact Homology’s proxy solicitor, Morrow Sodali, at the following address and telephone number:

Morrow Sodali LLC

430 Park Avenue, 14th Floor

New York, NY 10022

Banks and Brokers Call: (203) 658-9400

Stockholders Call Toll Free: (800) 662-5200

 

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OTHER MATTERS

Stockholder Proposals and Director Nominations

Homology stockholders who intend to have a proposal considered for inclusion in Homology’s proxy materials for presentation at the Homology annual meeting of stockholders to be held in 2024, or the 2024 Annual Meeting, pursuant to Rule 14a-8 under the Exchange Act must submit the proposal to Homology’s Secretary at Homology’s offices at One Patriots Park, Bedford, MA 01730 in writing not later than December 30, 2023.

Homology stockholders intending to present a proposal at Homology’s 2024 Annual Meeting, but not to include the proposal in its proxy statement, or to nominate a person for election as a director, must comply with the requirements set forth in the Amended and Restated Bylaws of Homology. The Amended and Restated Bylaws of Homology require, among other things, that Homology’s Secretary receive written notice from a stockholder of record of their intent to present such a proposal or nomination not earlier than the 120th day and not later than the 90th day prior to the anniversary of the preceding year’s annual meeting of stockholders. Therefore, Homology must receive notice of such a proposal or nomination for the 2024 Annual Meeting no earlier than February 15, 2024 and no later than March 16, 2024. The notice must contain the information required by the Amended and Restated Bylaws of Homology. In the event that the date of the 2024 Annual Meeting is more than 30 days before or more than 60 days after June 14, 2024, then Homology’s Secretary must receive such written notice not earlier than the close of business on the 120th day prior to the 2024 Annual Meeting and not later than the close of business of the 90th day prior to the 2024 Annual Meeting or, if later, the close of business of the 10th day following the day on which public disclosure of the date of such meeting is first made by Homology. SEC rules permit management to vote proxies in its discretion in certain cases if the stockholder does not comply with this deadline and, in certain other cases notwithstanding the Homology stockholder’s compliance with this deadline. In addition to satisfying the foregoing requirements under the Amended and Restated Bylaws of Homology, to comply with the universal proxy rules (once they become effective), Homology stockholders who intend to solicit proxies in support of director nominees other than Homology’s nominees must provide notice that sets forth the information required by Rule 14a-19 under the Exchange Act.

Homology reserves the right to reject, rule out of order or take other appropriate action with respect to any proposal that does not comply with these or other applicable requirements.

Homology intends to file a proxy statement and WHITE proxy card with the SEC in connection with the solicitation of proxies for Homology’s 2024 Annual Meeting of Homology stockholders. Homology stockholders may obtain the proxy statement (and any amendments and supplements thereto) and other documents as and when filed by Homology with the SEC without charge from the SEC’s website at: www.sec.gov.

Householding of Proxy Statement/Prospectus

SEC rules permit companies and intermediaries such as brokers to satisfy delivery requirements for proxy statements and notices with respect to two or more stockholders sharing the same address by delivering a single proxy statement or a single notice addressed to those stockholders. This process, which is commonly referred to as “householding”, provides cost savings for companies and helps the environment by conserving natural resources. Some brokers also household proxy materials, delivering a single proxy statement or notice to multiple stockholders sharing an address unless contrary instructions have been received from the affected stockholders. Homology agrees to deliver promptly, upon written or oral request, a separate copy of the notice or proxy materials, as requested, to any Homology stockholder at the shared address to which a single copy of those documents was delivered. If you would like to receive a separate copy of these documents, or if you receive multiple copies and would like to receive a single copy of these documents, contact Broadridge Financial Solutions, Inc. at 1-866-540-7095 or in writing at Broadridge, Householding Department, 51 Mercedes Way, Edgewood, New York 11717.

 

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0.030.030.030.030.030.03
INDEX TO FINANCIAL STATEMENTS
Consolidated Financial Statements of Homology Medicines, Inc. for the Years Ended December 31, 2022 and 2021
 
     F-2  
    
F-3
 
    
F-4
 
    
F-5
 
    
F-6
 
    
F-7
 
    
F-8
 
Unaudited Condensed Consolidated Financial Statements of Homology Medicines, Inc. for the Three and Nine Months Ended September 30, 2023 and 2022
 
    
F-33
 
    
F-34
 
    
F-35
 
    
F-36
 
    
F-38
 
    
F-39
 
Consolidated Financial Statements of Q32 Bio Inc. for the Years Ended December 31, 2022 and 2021
 
     F-61  
     F-62  
     F-63  
     F-64  
     F-65  
     F-66  
Unaudited Condensed Consolidated Financial Statements of Q32 Bio Inc. for the Nine Months Ended September 30, 2023 and 2022
 
     F-98  
     F-99  
     F-100  
     F-101  
     F-102  

Table of Contents
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the stockholders and the Board of Directors of Homology Medicines, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Homology Medicines, Inc. and its subsidiary (the “Company”) as of December 31, 2022 and 2021, the related consolidated statements of operations, comprehensive loss, stockholders’ equity, and cash flows, for the years then ended, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Deloitte & Touche LLP
Boston, Massachusetts
March 9, 2023
We have served as the Company’s auditor since 2017.
 
F-2

Table of Contents
HOMOLOGY MEDICINES, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts)
 
    
December 31,
 
    
2022
   
2021
 
Assets
    
Current assets:
    
Cash and cash equivalents
   $ 33,986     $ 108,382  
Short-term investments
     141,040       47,491  
Assets held for sale
     —         28,907  
Prepaid expenses and other current assets
     5,989       7,129  
  
 
 
   
 
 
 
Total current assets
     181,015       191,909  
Equity method investment
     25,814       —    
Property and equipment, net
     1,078       2,252  
Right-of-use
assets
     20,563       15,607  
Restricted cash
     —         1,953  
  
 
 
   
 
 
 
Total assets
   $ 228,470     $ 211,721  
  
 
 
   
 
 
 
Liabilities and stockholders’ equity
    
Current liabilities:
    
Accounts payable
   $ 1,144     $ 2,366  
Accrued expenses and other liabilities
     18,715       11,406  
Operating lease liabilities
     1,561       246  
Deferred revenue
     1,156       3,208  
  
 
 
   
 
 
 
Total current liabilities
     22,576       17,226  
Non-current
liabilities:
    
Operating lease liabilities, net of current portion
     27,916       23,688  
Deferred revenue, net of current portion
     —         1,156  
  
 
 
   
 
 
 
Total liabilities
     50,492       42,070  
  
 
 
   
 
 
 
Stockholders’ equity:
    
Preferred stock, $0.0001 par value, 10,000,000 shares authorized as of
December 31, 2022 and 2021; no shares issued and outstanding at
December 31, 2022 and 2021
     —         —    
Common stock, $0.0001 par value; 200,000,000 shares authorized as of
December 31, 2022 and 2021; 57,483,910 and 57,150,274
shares issued and outstanding as of December 31, 2022 and 2021,
respectively
     6       6  
Additional
paid-in
capital
     607,513       593,784  
Accumulated other comprehensive gain
     (404 )      (7 ) 
Accumulated deficit
     (429,137 )      (424,132 ) 
  
 
 
   
 
 
 
Total stockholders’ equity
     177,978       169,651  
  
 
 
   
 
 
 
Total liabilities and stockholders’ equity
   $ 228,470     $ 211,721  
  
 
 
   
 
 
 
See notes to consolidated financial statements.
 
F-
3

HOMOLOGY MEDICINES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
 
    
For the Year Ended
December 31,
 
    
        2022            
   
        2021        
 
Collaboration revenue
   $ 3,208     $ 33,971  
Operating expenses:
    
Research and development
     98,351       93,085  
General and administrative
     38,138       36,835  
  
 
 
   
 
 
 
Total operating expenses
     136,489       129,920  
  
 
 
   
 
 
 
Loss from operations
     (133,281 )      (95,949 ) 
  
 
 
   
 
 
 
Other income:
    
Gain on sale of business
     131,249       —    
Interest income
     3,230       185  
  
 
 
   
 
 
 
Total other income
     134,479       185  
  
 
 
   
 
 
 
Income (loss) before income taxes
     1,198       (95,764 ) 
  
 
 
   
 
 
 
Provision for income taxes
     (715 )      —    
Loss from equity method investment
     (5,488 )      —    
  
 
 
   
 
 
 
Net loss
   $ (5,005 )    $ (95,764 ) 
  
 
 
   
 
 
 
Net loss per share-basic and diluted
   $ (0.09 )    $ (1.73 ) 
  
 
 
   
 
 
 
Weighted average common shares outstanding-basic and diluted
     57,399,762       55,283,318  
  
 
 
   
 
 
 
See notes to consolidated financial statements.
 
F-
4

HOMOLOGY MEDICINES, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands)
 
    
For the Year Ended
December 31,
 
    
2022
   
2021
 
Net loss
   $ (5,005 )    $ (95,764 ) 
Other comprehensive gain (loss):
    
Change in unrealized gain (loss) on available for sale securities, net
     (397 )      (7 ) 
  
 
 
   
 
 
 
Total other comprehensive gain (loss)
     (397 )      (7 ) 
  
 
 
   
 
 
 
Comprehensive loss
   $ (5,402 )    $ (95,771 ) 
  
 
 
   
 
 
 
See notes to consolidated financial statements.
 
F-
5

HOMOLOGY MEDICINES, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands, except share and per share amounts)
 
    
Common Stock
$0.0001 Par Value
    
Additional
Paid-in
    
Accumulated
Other
Comprehensive
   
Accumulated
   
Total
Stockholders’
 
    
Shares
    
Amount
    
Capital
    
Gain (Loss)
   
Deficit
   
Equity
 
Balance at January 1, 2021
     50,265,575      $ 5      $ 524,358      $ —       $ (328,368 )      195,995  
Issuance of common stock in
follow-on
offering,
net of discounts and issuance costs
     6,596,306        1        49,743        —         —         49,744  
Vesting of common stock from
option exercises
     3,091        —          13        —         —         13  
Issuance of common stock from
option exercises
     59,465        —          145        —         —         145  
Issuance of common stock pursuant to
employee stock purchase plan
     110,923        —          826        —         —         826  
Issuance of common stock pursuant to ATM,
net of discounts and issuance costs
     114,914        —          1,454        —         —         1,454  
Stock-based compensation
     —          —          17,245        —         —         17,245  
Other comprehensive loss
     —          —          —          (7 )      —         (7 ) 
Net loss
     —          —          —          —         (95,764 )      (95,764 ) 
  
 
 
    
 
 
    
 
 
    
 
 
   
 
 
   
 
 
 
Balance at December 31, 2021
     57,150,274      $ 6      $ 593,784      $ (7 )    $ (424,132 )    $ 169,651  
  
 
 
    
 
 
    
 
 
    
 
 
   
 
 
   
 
 
 
Issuance of common stock from RSU vesting
     106,890                  —    
Issuance of common stock from
option exercises
     293        —          1        —         —         1  
Issuance of common stock pursuant to
employee stock purchase plan
     226,453        —          595        —         —         595  
Stock-based compensation
     —          —          13,054        —         —         13,054  
Stock-based compensation for equity method investee
           79            79  
Other comprehensive loss
     —          —          —          (397 )      —         (397 ) 
Net loss
     —          —          —          —         (5,005 )      (5,005 ) 
  
 
 
    
 
 
    
 
 
    
 
 
   
 
 
   
 
 
 
Balance at December 31, 2022
     57,483,910      $ 6      $ 607,513      $ (404 )    $ (429,137 )    $ 177,978  
  
 
 
    
 
 
    
 
 
    
 
 
   
 
 
   
 
 
 
See notes to consolidated financial statements.
 
F-
6

HOMOLOGY MEDICINES, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
 
    
For the Year Ended
December 31,
 
    
2022
   
2021
 
Cash flows from operating activities:
    
Net loss
   $ (5,005 )    $ (95,764 ) 
Adjustments to reconcile net loss to net cash used in operating activities:
    
Depreciation
     1,293       8,353  
Noncash lease expense
     1,306       1,191  
Loss from equity method investment
     5,488       —    
Stock-based compensation expense
     13,054       17,245  
(Accretion of discount) amortization of premium on short-term investments
     (1,947 )      894  
Loss on disposal of property and equipment
     49       133  
Gain on sale of business
     (131,249 )      —    
Changes in operating assets and liabilities:
    
Prepaid expenses and other current assets
     840       (4,996 ) 
Accounts payable
     (981 )      (2,487 ) 
Accrued expenses and other liabilities
     7,418       1,500  
Deferred revenue
     (3,208 )      (33,411 ) 
Operating lease liabilities
     (719 )      (2,409 ) 
  
 
 
   
 
 
 
Net cash used in operating activities
     (113,661 )      (109,751 ) 
  
 
 
   
 
 
 
Cash flows from investing activities:
    
Purchases of short-term investments
     (157,460 )      (97,392 ) 
Maturities of short-term investments
     65,461       49,000  
Proceeds from sale of business
     130,000       —    
Purchases of property and equipment
     (1,285 )      (2,396 ) 
  
 
 
   
 
 
 
Net cash provided by (used in) investing activities
     36,716       (50,788 ) 
  
 
 
   
 
 
 
Cash flows from financing activities:
    
Proceeds from issuance of common stock in
follow-on
public offering,
net of discounts and issuance costs
     —         49,744  
Proceeds from issuance of common stock pursuant to ATM financing,
net of discounts and issuance costs
     —         1,454  
Proceeds from issuance of common stock from option exercises
     1       145  
Proceeds from issuance of common stock pursuant to employee stock purchase plan
     595       826  
  
 
 
   
 
 
 
Net cash provided by financing activities
     596       52,169  
  
 
 
   
 
 
 
Net change in cash, cash equivalents and restricted cash
     (76,349 )      (108,370 ) 
Cash, cash equivalents and restricted cash, beginning of period
     110,335       218,705  
  
 
 
   
 
 
 
Cash, cash equivalents and restricted cash, end of period
   $ 33,986     $ 110,335  
  
 
 
   
 
 
 
Supplemental disclosures of noncash investing and financing activities:
    
Cash paid for income taxes
   $ 720     $ —    
  
 
 
   
 
 
 
Reclassification of liability for common stock vested
   $ —       $ 13  
  
 
 
   
 
 
 
Property and equipment additions included in accounts payable
   $ —       $ 241  
  
 
 
   
 
 
 
Property and equipment additions included in accrued expenses and other liabilities
   $ 8     $ 116  
  
 
 
   
 
 
 
Unrealized loss on available for sale securities, net
   $ (397 )    $ (7 ) 
  
 
 
   
 
 
 
See notes to consolidated financial statements.
 
F-
7

HOMOLOGY MEDICINES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
1. NATURE OF BUSINESS AND BASIS OF PRESENTATION
Nature of Business
—Homology Medicines, Inc. (the “Company”) is a clinical-stage genetic medicines company dedicated to transforming the lives of patients suffering from rare diseases by addressing the underlying cause of the disease with
one-time
gene therapy and gene editing treatments. The Company was founded in March 2015 as a Delaware corporation. Its principal offices are in Bedford, Massachusetts.
Since its inception, the Company has devoted substantially all of its resources to recruiting personnel, developing its technology platform and advancing its pipeline of product candidates through discovery, preclinical and clinical trials, developing and implementing manufacturing processes, building out manufacturing and research and development space, and maintaining and building its intellectual property portfolio. The Company is subject to a number of risks similar to those of other companies conducting high-risk, early-stage research and development of product candidates. Principal among these risks are dependency on key individuals and intellectual property, competition from other products and companies, and the technical and regulatory risks associated with the successful research, development and manufacturing of its product candidates. The Company’s success is dependent upon its ability to continue to raise additional capital in order to fund ongoing research and development, conduct clinical trials, obtain regulatory approval of its products, further expand access to manufacturing capacity, successfully commercialize its products, generate revenue, meet its obligations, and, ultimately, attain sustainable profitable operations.
On March 10, 2022, the Company closed a transaction with Oxford Biomedica plc (“Oxford”), to establish a new adeno-associated virus (“AAV”) vector manufacturing company, Oxford Biomedica Solutions (“OXB Solutions”) that provides AAV vector process development and manufacturing services to biotechnology companies. Under the terms of the agreement, the Company contributed its manufacturing team of 125 employees, manufacturing facility and equipment, manufacturing-related intellectual property and
know-how
and certain other assets. Oxford paid the Company $130.0 million of upfront cash and invested $50.0 million of cash to fund OXB Solutions in exchange for an 80 percent ownership interest, while Homology retained a 20 percent ownership interest in the new company and received a put option on this ownership position (see Note 6).
On April 6, 2021, the Company completed a
follow-on
public offering of its common stock. The Company sold 6,596,306 shares of its common stock at a price of $7.58 per share and received net proceeds of $49.7 million, after deducting offering expenses of $0.3 million. Under the terms of the underwriting agreement, the Company also granted the underwriter an option exercisable for 30 days to purchase up to an additional 989,445 shares of its common stock at a price of $7.58 per share. The underwriters did not exercise this option. The offering closed on April 9, 2021. The shares were sold pursuant to the Company’s effective shelf registration statement on Form
S-3,
as amended, and a related prospectus supplement filed with the Securities and Exchange Commission (“SEC”) on April 8, 2021.
On March 12, 2020, the Company filed a Registration Statement on Form
S-3
(File
No. 333-237131)
(as amended, the “Shelf”) with the SEC in relation to the registration of common stock, preferred stock, debt securities, warrants and/or units of any combination thereof for a period up to three years from the date of the filing. The Shelf became effective on March 12, 2020. The Company also simultaneously entered into a sales agreement with Cowen and Company, LLC (“TD Cowen”), as sales agent, providing for the offering, issuance and sale by the Company of up to an aggregate of $
150.0 million of its common stock from time to time in
“at-the-market”
offerings under the Shelf (the “ATM”). In connection with the filing of certain post-effective amendments to the Shelf, the sales agreement prospectus supplement now covers the offering, issuance and sale by the Company of up to an aggregate of $148.4 million of its common stock. The Company did not sell any
 
F-
8

shares of common stock under the Sales Agreement during the during the year ended December 31, 2022. As of December 31, 2022, there remained $148.4 million of common stock available for sale under the ATM. The Shelf will expire and no longer be effective, and accordingly will not be available for use for ATM offerings under the Sales Agreement, after March 12, 2023.
To date, the Company has not generated any revenue from product sales and does not expect to generate any revenue from the sale of product in the foreseeable future. Through December 31, 2022, the Company has financed its operations primarily through public offerings of its common stock, the issuance of convertible preferred stock, and with proceeds from its from its transaction with Oxford (see Note 6), its collaboration and license agreement with Novartis Institutes of BioMedical Research, Inc. (“Novartis”) (see Note 10) and its private placement with Pfizer (see Note 15). During the year ended December 31, 2022, the Company incurred a loss from operations of $133.3 million and as of December 31, 2022, had $429.1 million in accumulated deficit. The Company expects to incur additional operating losses and negative operating cash flows for the foreseeable future.
Based on current projections, management believes that cash and cash equivalents and short-term investments as of December 31, 2022 will enable the Company to continue its operations for at least one year from the date of this filing. In the absence of a significant source of recurring revenue, the continued viability of the Company beyond that point is dependent on its ability to continue to raise additional capital to finance its operations. There can be no assurance that the Company will be able to obtain sufficient capital to cover its costs on acceptable terms, if at all.
Basis of Presentation
—The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Principles of Consolidation
—The Company’s consolidated financial statements include the accounts of the Company and its subsidiary, Homology Medicines Securities Corporation, a wholly owned Massachusetts corporation, for the sole purpose of buying, selling, and holding securities on the Company’s behalf. All intercompany balances and transactions have been eliminated in the consolidated financial statements.
Use of Estimates
—The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, and expenses, and the disclosure of contingent assets and liabilities as of and during the reporting period. The Company bases its estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, revenue recognition, accrued research and development expenses and the valuation of the Company’s equity method investment. The Company assesses estimates on an ongoing basis; however, actual results could materially differ from those estimates.
Comprehensive Income (Loss) —
Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from
non-owner
sources. The Company’s only element of other comprehensive income (loss) is unrealized gains and losses on
available-for-sale
investments.
Cash and Cash Equivalents and Restricted Cash
—Cash and cash equivalents consist of standard checking accounts, money market accounts and certain investments. The Company considers all highly liquid investments with original or remaining maturities at the time of purchase of 90 days or less to be cash equivalents. Restricted cash consists of cash serving as collateral for letters of credit issued for security deposits for the Company’s facility leases in Bedford, Massachusetts.
 
F-
9

The following table provides a reconciliation of cash, cash equivalents and restricted cash to amounts shown in the consolidated statements of cash flows:
 
    
December 31,
 
    
2022
    
2021
 
    
(in thousands)
 
Cash and cash equivalents
   $ 33,986      $ 108,382  
Restricted cash
     —          1,953  
  
 
 
    
 
 
 
Total cash, cash equivalents and restricted cash
   $ 33,986      $ 110,335  
  
 
 
    
 
 
 
Short-Term Investments
—Short-term investments represent holdings of
available-for-sale
marketable securities in accordance with the Company’s investment policy and cash management strategy. Short-term investments have maturities of greater than 90 days at the time of purchase and mature within
one-year
from the balance sheet date. Investments in marketable securities are recorded at fair value, with any unrealized gains and losses, reported within accumulated other comprehensive income as a separate component of stockholders’ equity until realized or until a determination is made that an other-than-temporary decline in market value has occurred. Any premium or discount arising at purchase is amortized and/or accreted to interest income and/or expense over the life of the underlying security. Such amortization and accretion, together with interest on securities, are included in interest income in the Company’s consolidated statements of operations. The cost of marketable securities sold is determined based on the specific identification method and any realized gains or losses on the sale of investments are reflected as a component of other income.
Concentrations of Credit Risk
—Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash, cash equivalents and short-term investments. Periodically, the Company may maintain deposits in financial institutions in excess of government insured limits. The Company believes that it is not exposed to significant credit risk as its deposits are held at financial institutions that management believes to be of high credit quality and the Company has not experienced any losses on these deposits. The Company regularly invest excess cash with major financial institutions in money market funds, U.S. government and corporate debt securities and commercial paper, all of which can be readily purchased and sold using established markets. As of December 31, 2022, the Company’s cash and cash equivalents were held with two financial institutions. The Company believes that the market risk arising from its holdings of these financial instruments is mitigated based on the fact that many of these securities are either government-backed or of high credit rating.
Equity Method Investment—
The Company uses the equity method of accounting to account for an investment in an entity that it does not control, but in which it has the ability to exercise significant influence over operating and financial policies. The Company’s proportionate share of the net income or loss of the entity is included in consolidated net loss. Judgments regarding the level of influence over the equity method investment include consideration of key factors such as the Company’s ownership interest, representation on the board of directors or other management body and participation in policy-making decisions.
Under the equity method of accounting, the Company’s investment is initially recorded at fair value on the consolidated balance sheets. Upon initial investment, the Company evaluates whether there are basis differences between the carrying value and fair value of the Company’s proportionate share of the investee’s underlying net assets. Typically, the Company amortizes basis differences identified on a straight-line basis over the underlying assets’ estimated useful lives when calculating the attributable earnings or losses, excluding the basis differences attributable to
in-process
research and development that has no alternative future use. If the Company is unable to attribute all of the basis differences to specific assets or liabilities of the investee, the residual excess of the cost of the investment over the proportional fair value of the investee’s assets and liabilities is considered to be equity method goodwill and is recognized within the equity investment balance, which is tracked separately within the Company’s memo accounts. The Company subsequently records in the statements of operations its
 
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share of income or loss of the other entity within other income/expense, which results in an increase or decrease to the carrying value of the investment. If the share of losses exceeds the carrying value of the Company’s investment, the Company will suspend recognizing additional losses and will continue to do so unless it commits to providing additional funding; however, if there are intra-entity profits this can cause the investment balance to go negative.
The Company evaluates its equity method investments for impairment whenever events or changes in circumstances indicate that a decline in value has occurred that is other than temporary. Evidence considered in this evaluation includes, but would not necessarily be limited to, the financial condition and near-term prospects of the investee, recent operating trends and forecasted performance of the investee, market conditions in the geographic area or industry in which the investee operates and the Company’s strategic plans for holding the investment in relation to the period of time expected for an anticipated recovery of its carrying value. If the investment is determined to have a decline in value deemed to be other than temporary it is written down to estimated fair value.
At December 31, 2022, the Company accounted for its investment in OXB Solutions using the equity method of accounting (see Note 6).
Offering Costs
—The Company capitalizes incremental legal, professional accounting and other third-party fees that are directly associated with equity financings as other current assets until the transactions are completed. After equity financings are complete, these costs are recorded in stockholders’ equity as a reduction of additional
paid-in
capital generated as a result of the offering.
Leases
— The Company determines if an arrangement is a lease at contract inception. The Company’s contracts are determined to contain a lease when all of the following criteria based on the specific circumstances of the arrangement are met: (1) there is an identified asset for which there are no substantive substitution rights; (2) the Company has the right to obtain substantially all of the economic benefits from the identified asset; and (3) the Company has the right to direct the use of the identified asset.
At the commencement date, operating lease liabilities and their corresponding
right-of-use
assets are recorded based on the present value of future lease payments over the expected lease term. The Company’s lease agreements do not provide an implicit rate. As a result, the Company utilizes an estimated incremental borrowing rate to discount lease payments, which is based on the rate of interest the Company would have to pay to borrow a similar amount on a collateralized basis over a similar term. Certain adjustments to the
right-of-use
asset may be required for items such as initial direct costs paid or lease incentives received. Operating lease cost is recognized over the expected term on a straight-line basis. The expected lease term includes noncancelable lease periods and, when applicable, periods covered by an option to extend the lease if the Company is reasonably certain to exercise that option, as well as periods covered by an option to terminate the lease if the Company is reasonably certain not to exercise that option. Variable lease cost is recognized as incurred.
Right-of-use
assets are periodically evaluated for impairment.
The Company acts as sublessor related to a sublease of a substantial portion of the Company’s headquarters that is now occupied by OXB Solutions (see Note 16). Fixed sublease payments received are recorded as a reduction to lease cost. Although Homology assigned all of its right, title and interest in, to and under this lease to OXB Solutions, the Company remains jointly and severally liable for the payment of rent under this lease and was not released from being the primary obligor under such lease. Therefore, the related
right-of-use
asset and operating lease liability were not derecognized and remain on the Company’s consolidated balance sheets.
Guarantees and Indemnifications
—As permitted under Delaware law, the Company indemnifies its officers, directors, consultants and employees for certain events or occurrences that happen by reason of the relationship with, or position held at, the Company. Through December 31, 2022, the Company had not experienced any losses related to these indemnification obligations, and no claims were outstanding. The
 
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Company does not expect significant claims related to these indemnification obligations and, consequently, concluded
that
the fair value of these obligations is negligible, and no related liabilities have been established.
Property and Equipment
—Property and equipment are recorded at cost. Expenditures for repairs and maintenance are expensed as incurred. When assets are retired or disposed of, the assets and related accumulated depreciation are derecognized from the accounts, and any resulting gain or loss is included in the determination of net loss. Depreciation is provided using the straight-line method over the estimated useful lives of the related assets. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the asset.
 
Computer equipment and software    3 years
Laboratory equipment and office furniture    5 years
Manufacturing equipment    5 - 7 years
Leasehold improvements    Shorter of the lease term
or estimated useful life
Assets Held for Sale
—The Company classifies assets as held for sale when the following conditions are met: (1) management has committed to a plan to sell, (2) the assets are available for immediate sale in their present condition, (3) the Company has initiated an active program to identify a buyer, (4) it is probable that a sale will occur within one year, (5) the assets are actively marketed for sale at a reasonable price in relation to their current fair value, and (6) there is a low likelihood of significant changes to the plan or that the plan will be withdrawn. If all of the criteria are met as of the balance sheet date, the assets are presented separately in the consolidated balance sheet as held for sale at the lower of the carrying amount or fair value less costs to sell. The assets are then no longer depreciated or amortized while classified as held for sale.
Impairment of Long-Lived Assets
—The Company evaluates its long-lived assets, which consist primarily of property and equipment and
right-of-use
assets, for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the future undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the asset exceeds the fair value of the asset. To date, no impairments have been recognized for these assets.
Research and Development Costs
—Research and development costs are charged to expense as incurred. Research and development expense consists of expenses incurred in performing research and development activities, including salaries and benefits, materials and supplies, preclinical and clinical expenses, stock-based compensation expense, depreciation of equipment, contract services, and other outside expenses.
Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasks using information provided to the Company by its vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the consolidated financial statements as prepaid expense or accrued research and development expense.
Income Taxes
—The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the Company’s consolidated financial statements and tax returns. Deferred tax assets and liabilities are determined based upon the differences between the financial statement carrying amounts and the tax bases of existing assets and liabilities and for loss and credit carryforwards, using enacted tax rates expected to be in effect in the year in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if it is more likely than not that these assets may not be realized. The Company determines whether it is more likely than not that a tax position will be sustained upon examination. The tax benefit to be recognized for any tax position that meets the more-likely-
 
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than-not
recognition threshold is calculated as the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement. If it is not more likely than not that a position will be sustained, none of the benefit attributable to the position is recognized.
The Company accounts for interest and penalties related to uncertain tax positions as part of its provision for income taxes. Since inception, the Company has provided a valuation allowance for
the
full amount of the net deferred tax assets as the realization of the net deferred tax assets has not been determined to be more likely than not.
Segment Information
—Operating segments are identified as components of an enterprise about which separate discrete financial information is made available for evaluation by the chief operating decision maker (“CODM”) in making decisions regarding resource allocation and assessing performance. The CODM is the Company’s Chief Executive Officer. The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company’s singular focus is dedicated to translating proprietary gene editing and gene therapy technology into novel treatments for patients with rare genetic diseases. All of the Company’s tangible assets are held in the United States.
Revenue Recognition—
Revenue is recognized in accordance with FASB Accounting Standards Codification (“ASC”) Topic 606,
Revenue from Contracts with Customers
(“ASC 606”). Under ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine the appropriate amount of revenue to be recognized for arrangements determined to be within the scope of ASC 606, the Company performs the following five steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect consideration it is entitled to in exchange for the goods or services it transfers to the customer.
The promised goods or services in the Company’s arrangements would likely consist of a license, rights to the Company’s intellectual property or research, development and manufacturing services. Performance obligations are promised goods or services in a contract to transfer a distinct good or service to the customer and are considered distinct when (i) the customer can benefit from the good or service on its own or together with other readily available resources and (ii) the promised good or service is separately identifiable from other promises in the contract. In assessing whether promised goods or services are distinct, the Company considers factors such as the stage of development of the underlying intellectual property, the capabilities of the customer to develop the intellectual property on its own or whether the required expertise is readily available and whether the goods or services are integral or dependent to other goods or services in the contract.
The Company estimates the transaction price based on the amount expected to be received for transferring the promised goods or services in the contract. The consideration may include fixed consideration and variable consideration. At the inception of each arrangement that includes variable consideration, the Company evaluates the amount of consideration to which the Company expects to be entitled to. The Company utilizes either the most likely amount method or expected value method to estimate the amount expected to be received based on which method best predicts the amount expected to be received. The amount of variable consideration that is included in the transaction price may be constrained and is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period.
The Company’s contracts may include development and regulatory milestone payments that are assessed under the most likely amount method and constrained until it is probable that a significant revenue reversal would not occur. Milestone payments that are not within the Company’s control, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. At the end of each reporting
 
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period, the Company
re-evaluates
the probability of achievement of such development and regulatory milestones and any related constraint, and if necessary, adjust its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative
catch-up
basis, which would affect collaboration revenue in the period of adjustment.
For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from the Company’s collaboration arrangement.
The Company allocates the transaction price based on the estimated standalone selling price of each performance obligation. The Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. The Company utilizes key assumptions to determine the stand-alone selling price, which may include other comparable transactions, pricing considered in negotiating the transaction and the estimated costs. Variable consideration is allocated specifically to one or more performance obligations in a contract when the terms of the variable consideration relate to the satisfaction of the performance obligation and the resulting amounts allocated are consistent with the amounts the Company would expect to receive for the satisfaction of each performance obligation.
The consideration allocated to each performance obligation is recognized as revenue when control is transferred for the related goods or services. For performance obligations which consist of licenses and other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress. The Company evaluates the measure of progress for its over-time arrangements at each reporting period and, if necessary, updates the measure of progress and revenue recognized.
Stock-based Compensation
—The Company recognizes compensation expense for awards to employees and
non-employees
based on the grant date fair value of stock-based awards on a straight-line basis over the period during which an award holder provides service in exchange for the award. The fair value of options on the date of grant is calculated using the Black-Scholes option pricing model based on key assumptions such as stock price, expected volatility and expected term. The Company’s estimates of these assumptions are primarily based on the trading price of the Company’s stock, historical data, peer company data and judgment regarding future trends and factors. The Company recognizes forfeitures as they occur.
The purchase price of common stock under the Company’s employee stock purchase plan (“ESPP”) is equal to 85% of the lesser of (i) the fair market value per share of the common stock on the first business day of an offering period and (ii) the fair market value per share of the common stock on the purchase date. The fair value of the look-back provision under the ESPP is calculated using the Black-Scholes option pricing model. The fair value of the look-back provision plus the 15% discount is recognized as compensation expense over the
180-day
purchase period.
Fair Value Measurements
—Certain assets and liabilities are reported on a recurring basis at fair value. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:
 
  •  
Level 1—Quoted prices (unadjusted) in active markets for identical assets or liabilities.
 
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  •  
Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
 
  •  
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
Net Loss per Share
—Basic net loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding during the period. Diluted net loss per share is computed using the weighted-average number of common shares outstanding during the period and, if dilutive, the weighted-average number of potential shares of common stock. The weighted-average number of common shares included in the computation of diluted net loss gives effect to all potentially dilutive common equivalent shares, including outstanding stock options, restricted stock units and unvested shares of common stock.
Common stock equivalent shares are excluded from the computation of diluted net loss per share if their effect is antidilutive. In periods in which the Company reports a net loss attributable to common stockholders, diluted net loss per share attributable to common stockholders is generally the same as basic net loss per share attributable to common stockholders, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive.
Recent Accounting Pronouncements
—The Jumpstart Our Business Startups Act of 2012 permits an emerging growth company to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. As an emerging growth company, the Company has elected to take advantage of this extended transition period.
In June 2016, the FASB issued ASU
No. 2016-13,
Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU
2016-13”)
to improve financial reporting by requiring more timely recording of credit losses on loans and other financial instruments held by financial institutions and other organizations. ASU
2016-13
requires the measurement of all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. ASU
2016-13
also requires enhanced disclosures to help investors and other financial statement users better understand significant estimates and judgments used in estimating credit losses, as well as the credit quality and underwriting standards of an organization’s portfolio. The Company adopted ASU
2016-13
on January 1, 2023. The adoption of ASU
2016-13
did not have a material impact on the Company’s consolidated financial statements and related disclosures.
3. CASH AND CASH EQUIVALENTS
From time to time, the Company may have cash balances in financial institutions in excess of federal deposit insurance limits. The Company has never experienced any losses related to these balances. The Company considers only those investments that are highly liquid, readily convertible to cash, and that mature within three months from date of purchase to be cash equivalents.
The following table summarizes the Company’s cash and cash equivalents:
 
    
December 31,
 
    
2022
    
2021
 
    
(in thousands)
 
Cash
   $ 19      $ 59  
Money market funds
     33,967        108,323  
  
 
 
    
 
 
 
Total cash and cash equivalents
   $ 33,986      $ 108,382  
  
 
 
    
 
 
 
 
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4. SHORT-TERM INVESTMENTS
The Company may invest its excess cash in fixed income instruments denominated and payable in U.S. dollars including U.S. treasury securities, commercial paper, corporate debt securities and asset-backed securities in accordance with the Company’s investment policy that primarily seeks to maintain adequate liquidity and preserve capital.
The following table summarizes the Company’s short-term investments as of December 31, 2022 and December 31, 2021:
 
As of December 31, 2022
  
Amortized
Cost
    
Unrealized
Gains
    
Unrealized
Losses
    
Fair Value
 
    
(in thousands)
 
Commercial paper
   $ 57,138      $ —        $ —        $ 57,138  
US Treasury securities
     65,160        —          (335 )       64,825  
Corporate debt securities
     19,146        —          (69 )       19,077  
  
 
 
    
 
 
    
 
 
    
 
 
 
Total
   $ 141,444      $ —        $ (404 )     $ 141,040  
  
 
 
    
 
 
    
 
 
    
 
 
 
 
As of December 31, 2021
  
Amortized
Cost
    
Unrealized
Gains
    
Unrealized
Losses
    
Fair Value
 
    
(in thousands)
 
Commercial paper
   $ 27,992      $ —        $ —        $ 27,992  
Corporate debt securities
     19,506        —          (7 )       19,499  
  
 
 
    
 
 
    
 
 
    
 
 
 
Total
   $ 47,498      $ —        $ (7 )     $ 47,491  
  
 
 
    
 
 
    
 
 
    
 
 
 
The Company utilizes the specific identification method in computing realized gains and losses. The Company had no realized gains and losses on its
available-for-sale
securities for the years ended December 31, 2022 and 2021. The contractual maturity dates of all of the Company’s investments are less than one year.
5. FAIR VALUE MEASUREMENTS
The Company’s financial instruments consist of cash and cash equivalents, short-term investments, restricted cash and accounts payable. The carrying amount of cash, restricted cash and accounts payable are each considered a reasonable estimate of fair value due to the short-term maturity.
Assets measured at fair value on a recurring basis were as follows:
 
Description
  
December 31,
2022
    
Quoted Prices
(Unadjusted) in
Active Markets
for Identical
Assets
(Level 1)
    
Significant
Other
Observable
Inputs
(Level 2)
    
Significant
Unobservable
Inputs
(Level 3)
 
    
(in thousands)
 
Cash equivalents:
           
Money market mutual funds
   $ 33,967      $ 33,967      $ —        $ —    
  
 
 
    
 
 
    
 
 
    
 
 
 
Total cash equivalents
   $ 33,967      $ 33,967      $ —        $ —    
  
 
 
    
 
 
    
 
 
    
 
 
 
Short-term investments:
           
Commercial paper
   $ 57,138      $ —        $ 57,138      $ —    
US Treasury securities
     64,825        —          64,825        —    
Corporate debt securities
     19,077        —          19,077        —    
  
 
 
    
 
 
    
 
 
    
 
 
 
Total short-term investments
   $ 141,040      $ —        $ 141,040      $ —    
  
 
 
    
 
 
    
 
 
    
 
 
 
Total financial assets
   $ 175,007      $ 33,967      $ 141,040      $ —    
  
 
 
    
 
 
    
 
 
    
 
 
 
 
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Description
  
December 31,
2021
    
Quoted Prices
(Unadjusted) in
Active Markets
for Identical
Assets
(Level 1)
    
Significant
Other
Observable
Inputs
(Level 2)
    
Significant
Unobservable
Inputs
(Level 3)
 
    
(in thousands)
 
Cash equivalents:
           
Money market mutual funds
   $ 108,323      $ 108,323      $ —        $ —    
  
 
 
    
 
 
    
 
 
    
 
 
 
Total cash equivalents
   $ 108,323      $ 108,323      $ —        $ —    
  
 
 
    
 
 
    
 
 
    
 
 
 
Short-term investments:
           
Commercial paper
   $ 27,992      $ —        $ 27,992      $ —    
Corporate debt securities
     19,499        —          19,499        —    
  
 
 
    
 
 
    
 
 
    
 
 
 
Total short-term investments
   $ 47,491      $ —        $ 47,491      $ —    
  
 
 
    
 
 
    
 
 
    
 
 
 
Total financial assets
   $ 155,814      $ 108,323      $ 47,491      $ —    
  
 
 
    
 
 
    
 
 
    
 
 
 
Short-term securities are valued using models or other valuation methodologies that use Level 2 inputs. These models are primarily industry-standard models that consider various assumptions, including time value, yield curve, volatility factors, default rates, current market and contractual prices for the underlying financial instruments, as well as other relevant economic measures. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace.
There were no transfers between fair value measurement levels during the years ended December 31, 2022 and 2021.
6. EQUITY METHOD INVESTMENT
Summary of Transaction
On March 10, 2022, the Company closed a transaction with OXB Solutions, Oxford Biomedica (US), Inc., (“OXB”), and Oxford, pursuant to the Equity Securities Purchase Agreement (the “Purchase Agreement”), dated as of January 28, 2022, by and among Homology, OXB Solutions and Oxford, whereby, among other things, Homology and Oxford agreed to collaborate to operate OXB Solutions, which provides AAV vector process development and manufacturing services to pharmaceutical and biotechnology companies (the “OXB Solutions Transaction”).
Pursuant to the terms of the Purchase Agreement and a contribution agreement (the “Contribution Agreement”) entered into between Homology and OXB Solutions prior to the closing of the OXB Solutions Transaction (the “Closing”), Homology contributed its manufacturing team of 125 employees and assigned and transferred to OXB Solutions all of its assets that are primarily used in the manufacturing of AAV vectors for use in gene therapy and gene editing products, including its manufacturing facility and equipment and manufacturing-related intellectual property and
know-how,
but excluding certain assets related to manufacturing or testing of Homology’s proprietary AAV vectors (collectively, the “Transferred Assets”), in exchange for 175,000 common equity units in OXB Solutions (“Units”), representing 100 percent (100%) of the ownership interest of OXB Solutions, and OXB Solutions assumed from the Company, and agreed to pay, perform and discharge when due, all of the Company’s duties, obligations, liabilities, interests and commitments of any kind under, arising out of or relating to the Transferred Assets.
Effective as of the Closing, Homology sold to OXB, and OXB purchased from Homology, 130,000 Units, (the “Transferred Units”) in exchange for $130.0 million of cash consideration. In connection with the Closing, OXB contributed $50.0 million in cash to OXB Solutions in exchange for an additional, newly issued 50,000
 
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Units. Immediately following the Closing, (i) OXB owned 180,000 Units, representing 80 percent (80%) of the fully diluted equity interests in OXB Solutions, and (ii) Homology owned 45,000 Units, representing 20 percent (20%) of the fully diluted equity interests in OXB Solutions.
Pursuant to the Amended and Restated Limited Liability Company Agreement of OXB Solutions (the “OXB Solutions Operating Agreement”) which was executed in connection with the Closing, at any time following the three-year anniversary of the Closing, (i) OXB will have an option to cause Homology to sell and transfer to OXB, and (ii) Homology will have an option to cause OXB to purchase from Homology, in each case all of Homology’s equity ownership interest in OXB Solutions at a price equal to 5.5 times the revenue for the immediately preceding
12-month
period (together, the “Options”), subject to a maximum amount of $74.1 million.
Pursuant to the terms of the OXB Solutions Operating Agreement, Homology is entitled to designate one director to the board of directors of OXB Solutions, currently Albert Seymour, Homology’s Chief Executive Officer. Further, Tim Kelly, Homology’s former Chief Operating Officer, serves as the Chief Executive Officer and chairman of the board of OXB Solutions.
The fixed assets transferred to the new company as part of this transaction met the assets held for sale criteria and were reclassified to assets held for sale as of December 31, 2021. The Company determined that the carrying value of the assets held for sale did not exceed fair value less costs to sell, which resulted in no impairment charge for the year ended December 31, 2021. As of December 31, 2021, the Company presented $28.9 million of fixed assets transferred to OXB Solutions as a current asset under the caption of “assets held for sale” in its consolidated balance sheet.
Pursuant to the OXB Solutions Transaction, the Company also assigned all of its right, title and interest in, to and under its facility lease to the new company. However, as the Company remains jointly and severally liable for the payment of rent under the facility lease, the Company has not been released from being the primary obligor under such lease and therefore the related
right-of-use
asset and lease liability are not derecognized and will remain on the Company’s balance sheet. The Company determined that the expected disposal of the fixed assets did not qualify for reporting as a discontinued operation since it did not represent a strategic shift that has or will have a major effect on the Company’s operations and financial results.
Equity Method of Accounting
The Company has significant influence over, but does not control, OXB Solutions through its noncontrolling representation on OXB’s board of directors and the Company’s equity interest in OXB Solutions. In addition, the Company and OXB Solutions have intra-entity transactions through a series of agreements entered into in conjunction with the OXB Solutions Transaction, OXB Solutions granted certain licenses to the Company, and the Company has representation on the joint steering committee which oversees the activities governed by the Supply Agreement. Accordingly, the Company does not consolidate the financial statements of OXB Solutions and accounts for its investment using the equity method of accounting.
The Company recorded its equity method investment in OXB Solutions at fair value upon deconsolidation of OXB Solutions as of the Closing. The fair value of the equity method investment was determined based on the market approach. This approach estimated the fair value of OXB Solutions based on the implied value for the entity using the consideration paid, including the Options, for a controlling interest in OXB Solutions at the entity’s formation. As part of its fair value analysis, the Company determined that the Options are embedded in the common equity units because the Options are not legally detachable or separately exercisable. Accordingly, the equity method investment and the Options represent one unit of account and the fair value recorded reflects the value of the equity interest and the Options. The valuation included certain subjective assumptions including discounts for lack of control and marketability given the consideration paid for OXB Solutions was for a controlling interest in the entity and the Company owns a noncontrolling interest.
 
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As of March 10, 2022, the Closing, the fair value of the Company’s investment in OXB Solutions was $31.2 million and the Company recorded a gain of $131.2 million on the sale of its manufacturing business in other income in the Company’s consolidated statements of operations. The gain was computed as follows:
 
(in thousands)
  
March 10, 2022
 
Cash received
   $ 130,000  
Plus: Fair value of equity method investment
     31,223  
Less: Carrying value of transferred assets
     (29,974 ) 
  
 
 
 
Gain on sale of business
   $ 131,249  
  
 
 
 
In addition, the Company records its share of income or losses from OXB Solutions on a quarterly basis. For the year ended December 31, 2022, the Company recorded $5.5 million representing its share of OXB Solution’s net loss. As of December 31, 2022, the carrying value of the equity method investment was $25.8 million.
Summarized Financial Information
Summarized financial information for OXB Solutions is as follows:
 
    
December 31,
2022
 
Balance Sheet Data
  
(in thousands)
 
Current assets
   $ 39,237  
Noncurrent assets
   $ 228,745  
Current liabilities
   $ 12,352  
Noncurrent liabilities
   $ 37,718  
 
    
December 31,
2022
 
Statement of Operations Data
  
(in thousands)
 
Revenues
   $ 29,380  
Net loss
   $ 29,036  
See Note 16 for information regarding the Company’s related party transactions with OXB Solutions.
7. PROPERTY AND EQUIPMENT
Property and equipment, net consists of the following:
 
    
December 31,
 
    
2022
    
2021
 
    
(in thousands)
 
Laboratory equipment
   $ 6,025      $ 5,857  
Computers and purchased software
     644        1,596  
Furniture and fixtures
     645        645  
  
 
 
    
 
 
 
Property and equipment, at cost
     7,314        8,098  
Less accumulated depreciation and amortization
     (6,236 )       (5,846 ) 
  
 
 
    
 
 
 
Property and equipment, net
   $ 1,078      $ 2,252  
  
 
 
    
 
 
 
Depreciation expense for the years ended December 31, 2022 and 2021 was approximately $1.3 million and $8.4 million, respectively. The Company disposed of approximately $0.1 million of property and equipment, net during each of the years ended December 31, 2022 and 2021. As of December 31, 2021, the Company has classified an additional $28.9 million of property and equipment, net in assets held for sale (see Note 6).
 
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8. ACCRUED EXPENSES AND OTHER LIABILITIES
Accrued expenses and other liabilities consist of the following:
 
    
December 31,
 
    
2022
    
2021
 
    
(in thousands)
 
Accrued research and development expenses
   $ 9,447      $ 2,193  
Accrued compensation and benefits
     5,953        7,805  
Accrued professional fees
     1,052        1,371  
Accrued other
     2,263        37  
  
 
 
    
 
 
 
Total accrued expenses and other liabilities
   $ 18,715      $ 11,406  
  
 
 
    
 
 
 
9. COMMITMENTS AND CONTINGENCIES
Operating Leases
—In September 2016, the Company entered into a noncancelable operating lease beginning in November 2016 for office, laboratory and manufacturing space in Bedford, Massachusetts, that expired in October 2021, with an option for an additional three-year term that was not exercised. In 2018, the Company entered into a sublease agreement for the entire leased premises. The rent commencement date of the sublease was December 2018, and the sublease terminated on the scheduled termination date of the original lease. Under the terms of the sublease, the subtenant was obligated to pay the Company aggregate base rent of approximately $2.7 million over the term of the sublease, based on the same level of rent the Company was obligated to pay the landlord, in addition to a passthrough of operating expenses and real estate taxes charged by the landlord.
In December 2017, the Company entered into a noncancelable operating lease for approximately 67,000 square feet of research and development, manufacturing and general office space in Bedford, Massachusetts. Prior to a subsequent amendment described below, the lease was set to expire in February 2027 with an option for an additional five-year term. Rent became due under the lease in two phases; rent on the first 46,000 square feet started in September 2018 and rent on the remaining 21,000 square feet started in March 2019. The initial annual base rent was $39.50 per square foot and increases by
three
percent
annually. The Company is obligated to pay, on a
pro-rata
basis, real estate taxes and operating costs related to the premises. The lease agreement entered into in December 2017 allowed for a tenant improvement allowance not to exceed $10.9 million, which the Company received in full, to be applied to the total cost of tenant improvements to the leased premises. The unamortized balance of the tenant improvement allowance was included in deferred rent incentives and has been recorded as a reduction to operating
right-of-use
asset upon adoption of the new leasing standards.
In November 2021, the Company entered into an amendment of its December 2017 lease agreement (the “Lease Amendment”) for its corporate headquarters in Bedford, Massachusetts. The Lease Amendment increases the space under lease by approximately 23,011 square feet (the “Expansion Premises”) and extended the expiration date of the existing premises under the lease from February 2027 to June 2030. The payment term with respect to the Expansion Premises commences on the earlier of (i) the date of the Substantial Completion of the Tenant’s Work (as both terms are defined in the Lease Amendment), (ii) the Company’s occupancy of any portion of the Expansion Premises, and (iii) May 1, 2022, and continues for a period of ten years and five months. The term of the Expansion Premises and the existing premises are not coterminous. Annual base rent for the existing premise under the Lease Amendment is approximately $4.7 million beginning on March 1, 2027, and increases by three percent annually; annual base rent for the Expansion Premises is approximately $1.4 million per year and increases by three percent annually. The Lease Amendment allows for tenant improvement allowances not to exceed $6.3 million in the aggregate. The Lease Amendment was accounted for as a lease modification and the
right-of-use
asset and operating lease liability for the existing premises were remeasured at the modification date, which resulted in an increase of $10.9 million to both the
right-of-use
asset and operating lease liabilities. In February 2022, the Company revised its assumption for when it expects to utilize the tenant
 
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improvement allowances. This change in assumption was accounted for as a lease modification and the
right-of-use
asset and operating lease liability for the existing premises were remeasured at the modification date, which resulted in an increase of $0.2 million to both the
right-of-use
asset and operating lease liabilities.
In March 2022, in accordance with its transaction with OXB Solutions, the Company assigned all of its right, title and interest in, to and under its corporate headquarters lease to OXB Solutions and entered into a sublease agreement whereby OXB Solutions subleased certain premises in its facility to Homology. However, as the Company has not been released from being the primary obligor under such lease, the related
right-of-use
asset and operating lease liability were not derecognized and remain on the Company’s balance sheet and the Company acts as sublessor to OXB Solutions for accounting purposes. See Note 6 for details. For the year ended December 31, 2022, the Company received $2.0 million in sublease payments from OXB Solutions, which is recorded as a reduction to lease cost.
In September 2022, the Company concluded that 100% of the tenant improvement allowances would be utilized by OXB Solutions. This change in assumption was accounted for as a lease modification and the
right-of-use
asset and operating lease liability for the existing premises were remeasured at the modification date, which resulted in an increase of $6.1 million to both the
right-of-use
asset and operating lease liabilities.
The Company maintained letters of credit, secured by restricted cash, for security deposits totaling $2.0 million as of December 31, 2021 in conjunction with its leases. The Company had no security deposit or restricted cash as of December 31, 2022.
The following table summarizes operating lease costs and variable lease costs, as well as sublease income for the year ended December 31, 2022:
 
    
Years ended December 31,
 
    
        2022        
    
        2021        
 
    
(in thousands)
 
Operating lease costs
   $ 3,913      $ 2,592  
Variable lease costs
     2,142        2,127  
Sublease income
     (1,979 )       (861 ) 
  
 
 
    
 
 
 
Net lease cost
   $ 4,076      $ 3,858  
  
 
 
    
 
 
 
The maturities of our operating lease liabilities as of December 31, 2022 were as follows:
 
For the Years Ending December 31,
  
Amount
(in thousands)
 
2023
     4,444  
2024
     4,578  
2025
     4,715  
2026
     4,857  
Thereafter
     26,266  
  
 
 
 
Total undiscounted lease payments
   $ 44,860  
Less: imputed interest
     (15,383 ) 
  
 
 
 
Present value of operating lease liabilities
   $ 29,477  
  
 
 
 
 
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1

The following table summarizes the lease term and discount rate as of December 31, 2022:
 
    
As of
December 31, 2022
 
Weighted-average remaining lease term (years)
  
Operating leases
     8.2  
Weighted-average discount rate
  
Operating leases
       10.6 % 
The following table summarizes the supplemental cash flow information related to the Company’s operating leases for the year ended December 31, 2022.
 
    
Years ended December 31,
 
    
2022
    
2021
 
    
(in thousands)
 
Cash paid for amounts included in the measurement of lease liabilities
   $ 3,326      $ 3,810  
Increase in lease liabilities and
right-of-use
assets due to lease remeasurement
   $ 6,262      $ 10,901  
Legal Proceedings
—On March 25, 2022, the Company and certain of its executives were named as defendants in a putative securities class action lawsuit filed in the United States District Court for the Central District of California; Pizzuto v. Homology Medicines, Inc., No. 2:22–CV–01968 (C.D. Cal 2022). The complaint alleges that the Company failed to disclose certain information regarding efficacy and safety in connection with a Phase I/II
HMI-102
clinical trial, and seeks damages in an unspecified amount. The case is in its early stages. The Company believes the claims alleged lack merit and has filed a motion to transfer venue (filed September 2, 2022) and a motion to dismiss (filed October 17, 2022). Both of these motions remain pending. As the outcome is not presently determinable, any loss is neither probable nor reasonably estimable.
10. LICENSE AGREEMENTS
Novartis
In November 2017, the Company entered into a collaboration and license agreement with Novartis (as amended, the “Collaboration Agreement”) for the research, development, manufacturing and commercialization of products using the Company’s gene-editing technology for the treatment of certain ophthalmic targets and sickle cell disease. On February 26, 2021, Homology received notice from Novartis that they had elected to terminate the Collaboration Agreement with the Company with respect to the remaining ophthalmic target under the Collaboration Agreement and as a result, the Company regained worldwide exclusive rights to this target. Accordingly, the notice served as notice of Novartis’ termination of the Collaboration Agreement in its entirety, which became effective on August 26, 2021.
The Company recognized revenue under the Collaboration Agreement over time using a
cost-to-cost
method, which it believed best depicted the transfer of control to the customer. The delivery of the termination notice caused a change in the estimate of total costs to satisfy the single performance obligation under the Collaboration Agreement. The cumulative effect of revisions to the total estimated costs to complete the Company’s single performance obligation was recorded in the current period when the changes were identified and amounts could be reasonably estimated. As such, the Company recognized a cumulative effect adjustment of approximately $26.9 million in collaboration revenue during the year ended December 31, 2021.
As the Collaboration Agreement terminated in 2021, there was no revenue recorded in the year ended December 31, 2022. During the year ended December 31, 2021, the Company recognized revenue under the Collaboration Agreement of $30.8 million, of which $30.2 million was included in deferred revenue at the
 
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beginning of 2021. As of December 31, 2022 and 2021, there was no deferred revenue related to the Collaboration Agreement. There was no accounts receivable or deferred revenue on the Company’s consolidated balance sheets related to the Collaboration Agreement in either period presented.
City of Hope
In April 2016, the Company entered into an exclusive license agreement with City of Hope, or COH, an academic research and medical center. COH granted the Company an exclusive, sublicensable, worldwide license, or the COH License, to certain AAV vector-related patents and
know-how
owned by COH to develop, manufacture, use and commercialize products and services covered by such patents and
know-how
in any and all fields.
The Company is required to pay an annual license fee of $25,000, reimburse COH for patent costs incurred, pay amounts up to $3.2 million upon the achievement of certain development and commercialization milestones for each product under the license, pay royalties on future sales in the low single-digits and royalties on sublicense revenue in the low double-digits, if any. Other than the annual license fee, there were no payments to COH in 2021 or 2022. In January 2023, the Company paid $50,000 to COH upon dosing the first patient in the pheEDIT Phase 1 clinical trial.
On August 6, 2021, the Company received notice from COH that it did not accomplish at least one of the partnering milestones by the applicable deadline, as set forth in the COH License. This notice does not affect the Company’s exclusive license in the field of mammalian therapeutics, including all human therapeutics, associated diagnostics, and target validation, or the Mammalian Therapeutic Field, where the Company retains exclusive rights. Instead, the notice served as written notice that the exclusive license granted pursuant to the COH License in all fields except the Mammalian Therapeutic Field converted from exclusive to
non-exclusive
effective as of September 20, 2021, which was forty-five days from the receipt of notice. In connection with the conversion, any royalty obligations and sublicensee fees relating to fields outside of the Mammalian Therapeutic Field shall be reduced by a certain percentage. This change to the Company’s exclusive worldwide license with COH does not impact any of its current therapeutic product candidates in development, including
HMI-102,
HMI-103,
HMI-203,
HMI-204
and
HMI-104,
nor will it impact any potential future therapeutic product development candidates.
California Institute of Technology
In September 2016, the Company entered into a
co-exclusive
license agreement with the California Institute of Technology (“Caltech”), an academic research institute. The license term extends until the expiration, revocation, invalidation or unenforceability of the licensed patent rights. The Company is required to pay an annual minimal royalty fee of $20,000, reimburse for patent costs incurred, pay an amount up to $7.2 million upon the achievement of certain development and regulatory milestones and pay royalties on future sales in the low single-digits and royalties on sublicense revenue in the mid to high single-digits, if any. As of the date of this Annual Report, the Caltech technology is not utilized in any of the Company’s current therapeutic product candidates in development and the Company’s ongoing efforts with respect to the Caltech agreement are primarily focused on sublicensing the
AAV-related
patents owned by Caltech.
 
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11. INCOME TAXES
Provision for income taxes consists of the following:
 
    
For the Year Ended December 31,
 
    
        2022        
    
        2021        
 
    
(in thousands)
 
Federal tax provision:
     
Current
   $ 698      $ —    
Deferred
     —          —    
  
 
 
    
 
 
 
Total federal tax provision
     698        —    
State tax provision:
     
Current
     17        —    
Deferred
     —          —    
  
 
 
    
 
 
 
Total state tax provision
     17        —    
  
 
 
    
 
 
 
Total tax provision
   $ 715      $ —    
  
 
 
    
 
 
 
A reconciliation between the U.S. federal statutory tax and the Company’s tax provision is summarized below. The Company has changed the presentation of its rate reconciliation from percentages to dollar amounts in the current year.
 
      
For the Year Ended December 31,
 
      
        2022        
    
        2021        
 
      
(in thousands)
 
Federal statutory tax
     $ (901 )     $ (20,111 ) 
Tax credits
       (13,955 )       (8,940 ) 
State taxes, net of federal tax benefit
       (2,994 )       (8,240 ) 
Non-deductible
expenses
       875        1,331  
Other
       1,410        (2,401 ) 
Change in valuation allowance
       16,280        38,361  
    
 
 
    
 
 
 
Tax provision
     $ 715      $ —    
    
 
 
    
 
 
 
The principal components of the Company’s deferred tax assets and liabilities consist of the following:
 
    
December 31,
 
    
2022
    
2021
 
    
(in thousands)
 
Deferred tax assets:
     
Net operating losses
   $ 76,735      $ 100,417  
R&D credits
     66,761        51,705  
Equity compensation
     7,888        6,919  
Operating lease liabilities
     8,003        6,520  
Accrued expense and other
     1,479        2,072  
Deferred revenue
     314        1,189  
Capitalized R&D costs
     24,477        868  
  
 
 
    
 
 
 
Total deferred tax assets
     185,657        169,690  
 
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4

    
December 31,
 
    
2022
    
2021
 
    
(in thousands)
 
Deferred tax liabilities:
     
Right-of-use
assets
     (5,583 )       (4,252 ) 
Depreciation
     (171 )       (1,541 ) 
Other
     (251 )       (503 ) 
  
 
 
    
 
 
 
Total deferred tax liabilities
     (6,005 )       (6,296 ) 
  
 
 
    
 
 
 
Valuation allowance
     (179,652 )       (163,394 ) 
  
 
 
    
 
 
 
Net deferred taxes
   $ —        $ —    
  
 
 
    
 
 
 
The Company recorded an income tax provision of $0.7 million for the year ended December 31, 2022. The
year-to-date
tax provision predominately results from the gain associated with the sale of the Company’s manufacturing business due to the transaction with Oxford (see Note 6), offset by available federal and state net operating loss carryforwards and research and development tax credits which are subject to certain limitations as to their utilization. The Company did not record an income tax provision (benefit) for the year ended December 31, 2021.
At December 31, 2022, the Company had $283.5 million and $272.1 million of federal and state net operating loss carryforwards, respectively. Federal net operating loss carryforwards of $0.4 million, generated before 2018, will begin expiring in varying amounts through 2035 unless utilized. The remaining federal net operating loss carryforwards of $283.1 million, generated after 2017, will be carried forward indefinitely. The state net operating losses will begin expiring in varying amounts through 2041 unless utilized. At December 31, 2022, the Company had $55.1 million and $14.8 million of federal and state research and development credit carryforwards, respectively, that expire at various dates through 2041. Included in the $55.1 million of federal research and development credit carryforwards is $45.2 million of orphan drug credit carryforwards.
A valuation allowance is recorded against deferred tax assets if it is more likely than not that some or all of the deferred tax assets will not be realized. Due to the uncertainty surrounding the realization of the favorable tax attributes in future tax returns, the Company has recorded a full valuation allowance against the Company’s otherwise recognizable net deferred tax assets. A roll forward of the valuation allowance is as follows:
 
    
Valuation
Allowance
 
    
(in thousands)
 
Balance at December 31, 2021
   $ (163,394 ) 
Utilization of net operating losses against taxable income
     23,654  
Increase in net deferred taxes
     (39,912 ) 
  
 
 
 
Balance at December 31, 2022
   $ (179,652 ) 
  
 
 
 
For all years through December 31, 2022, the Company generated research credits but has not conducted a study to document the qualified activities. This study may result in an adjustment to the Company’s research and development credit carryforwards. Since a full valuation allowance has been provided against the Company’s research and development credits, any reduction in the gross deferred tax asset established for the research and development credit carryforwards would not result in any net impact to the Company’s consolidated financial statements.
 
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Realization of the future tax benefits is dependent on many factors, including the Company’s ability to generate taxable income within the net operating loss carryforward period. Under the provisions of the Internal Revenue Code, certain substantial changes in the Company’s ownership, including a sale of the Company or significant changes in ownership due to sales of equity, may have limited, or may limit in the future, the amount of net operating loss carryforwards that could be used annually to offset future taxable income. The Company completed a study to assess ownership changes through December 31, 2022. Based on this analysis, the net operating losses are limited but the Company does not believe that any of its net operating losses or research and development credit carryforwards will expire unutilized due to Section 382 limitations.
The Company files tax returns in the United States, Massachusetts and several other states. All tax years since inception remain open to examination by the major taxing jurisdictions to which the Company is subject, as carryforward attributes generated in years past may still be adjusted upon examination by the Internal Revenue Service (“IRS”) or other authorities if they have or will be used in a future period. The Company is not currently under examination by the IRS or any other jurisdictions for any tax years.
As of December 31, 2022, the Company had no uncertain tax positions. The Company has elected to recognize interest and penalties related to income tax matters as a component of income tax expense, of which no interest or penalties were recorded for the years ended December 31, 2022 and 2021.
12. STOCKHOLDERS’ EQUITY
Common Stock
—Voting, dividend and liquidation rights of the holders of the common stock are subject to and qualified by the rights, powers and preferences of the holders of the preferred stock.
Voting
—Each holder of outstanding shares of common stock are entitled to one vote in respect of each share. The holders of outstanding shares of common stock, voting together as a single class, shall be entitled to elect one director. The number of authorized shares of common stock may be increased or decreased by the affirmative vote of a majority of the outstanding shares of common stock and preferred stock voting together as a single class.
Dividends
—Subject to the payment in full of any preferential dividends to which the holders of preferred stock are entitled, the holders of common stock shall be entitled to receive dividends out of funds legally available therefore at such times and in such amounts as the Board of Directors may determine in its sole discretion.
Liquidation Rights
—In the event of any voluntary or involuntary liquidation, dissolution or
winding-up
of the Company, after the payment or provision for payment of all debts and liabilities of the Company and any preferential amounts to which the holders of preferred stock are entitled with respect to the distribution of assets in liquidation, the holders of common stock shall be entitled to share ratably in the remaining assets of the Company available for distribution.
There were 57,483,910 and 57,150,274 shares of common stock outstanding at December 31, 2022 and 2021, respectively.
Preferred Stock
—As of December 31, 2022 and 2021, there were no shares of preferred stock issued and outstanding.
 
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13. STOCK INCENTIVE PLANS
2015 Stock Incentive Plan
In December 2015, the Company’s Board of Directors adopted the 2015 Stock Incentive Plan (the “2015 Plan”), which provided for the grant of incentive stock options, nonqualified stock options and restricted stock awards to the Company’s employees, officers, directors, advisors, and outside consultants. Stock options granted under the 2015 Plan generally vest over a four-year period and expire ten years from the date of grant. Certain options provide for accelerated vesting if there is a change in control, as defined in the 2015 Plan. At December 31, 2022, there were no additional shares available for future grant under the 2015 Plan.
2018 Incentive Award Plan
In March 2018, the Company’s Board of Directors adopted and the Company’s stockholders approved the Homology Medicines, Inc. 2018 Incentive Award Plan (the “2018 Plan” and, together with the 2015 Plan, the “Plans”), which became effective on the day prior to the first public trading date of the Company’s common stock. Upon effectiveness of the 2018 Plan, the Company ceased granting new awards under the 2015 Plan.
The 2018 Plan provides for the grant of incentive stock options, nonqualified stock options, restricted stock awards, restricted stock units, stock appreciation rights and other stock or cash-based awards to employees and consultants of the Company and certain affiliates and directors of the Company. The number of shares of common stock initially available for issuance under the 2018 Plan was 3,186,205 shares of common stock plus the number of shares subject to awards outstanding under the 2015 Plan that expire, terminate or are otherwise surrendered, cancelled, forfeited or repurchased by the Company on or after the effective date of the 2018 Plan. In addition, the number of shares of common stock available for issuance under the 2018 Plan is subject to an annual increase on the first day of each calendar year beginning on January 1, 2019 and ending on and including January 1, 2028 equal to the lesser of (i) 4% of the Company’s outstanding shares of common stock on the final day of the immediately preceding calendar year and (ii) such smaller number of shares of common stock as determined by the Company’s Board of Directors, provided that not more than 20,887,347 shares of common stock may be issued under the 2018 Plan upon the exercise of incentive stock options. As of December 31, 2022, there were 2,188,360 shares available for future grant under the 2018 Plan. On January 1, 2023, an additional 2,299,356 shares were added to the 2018 Plan, representing 4% of total common shares outstanding at December 31, 2022.
2018 Employee Stock Purchase Plan
In March 2018, the Company’s Board of Directors adopted, and the Company’s stockholders approved, the Homology Medicines, Inc. 2018 Employee Stock Purchase Plan (the “2018 ESPP”). The 2018 ESPP allows employees to buy Company stock through
after-tax
payroll deductions at a discount from market value. The 2018 ESPP is intended to qualify as an “employee stock purchase plan” under Section 423 of the Internal Revenue Code. The number of shares of common stock initially available for issuance under the 2018 ESPP was 353,980 shares of common stock plus an annual increase on the first day of each calendar year beginning on January 1, 2019 and ending on and including January 1, 2028 equal to the lesser of (i) 1% of the Company’s outstanding shares of common stock on the final day of the immediately preceding calendar year and (ii) such smaller number of shares of common stock as determined by the Company’s Board of Directors, provided that not more than 4,778,738 shares of common stock may be issued under the 2018 ESPP. As of December 31, 2022, there were 1,776,431 shares available for future grant under the 2018 ESPP. On January 1, 2023, an additional 574,839 shares were added to the 2018 ESPP, representing 1% of total common shares outstanding at December 31, 2022.
Under the 2018 ESPP, employees may purchase common stock through
after-tax
payroll deductions at a price equal to 85% of the lower of the fair market value on the first trading day of an offering period or the last trading day of an offering period. The 2018 ESPP generally provides for offering periods of six months in duration that end on the final trading day of each February and August. In accordance with the Internal Revenue
 
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Code, no employee will be permitted to accrue the right to purchase stock under the 2018 ESPP at a rate in excess of $25,000 worth of shares during any calendar year during which such a purchase right is outstanding (based on the fair market value per share of the Company’s common stock as of the first day of the offering period).
During the year ended December 31, 2022, 226,453 shares were issued under the 2018 ESPP for aggregate proceeds to the Company of $0.6 million. During the year ended December 31, 2021, 110,923 shares were issued under the 2018 ESPP for aggregate proceeds to the Company of $0.8 million. Pursuant to the 2018 ESPP, the Company recorded stock-based compensation of less than $0.1 million and $0.1 million for the years ended December 31, 2022 and 2021, respectively.
Stock Options
The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing model, with the assumptions noted in the table below. Expected volatility for the Company’s common stock was determined based on an average of the historical volatility of a peer group of publicly traded companies that are similar to the Company. The expected term of options was calculated using the simplified method, which represents the average of the contractual term of the option and the weighted-average vesting period of the option. The Company uses the simplified method because it does not have sufficient historical option exercise data to provide a reasonable basis upon which to estimate expected term. The assumed dividend yield is based upon the Company’s expectation of not paying dividends in the foreseeable future. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for periods commensurate with the expected term of the award. The Company recognizes forfeitures as they occur.
The assumptions used in the Black-Scholes option pricing model are as follows:
 
    
For the Year Ended December 31,
    
2022
  
2021
Expected volatility
  
68.7% - 70.1%
   64.6% - 71.7%
Weighted-average risk-free interest rate
   1.46% - 4.16%   
0.50% - 1.33%
Expected dividend yield
   —  %    —  %
Expected term (in years)
   5.5 - 6.25    5.5 - 6.25
Underlying common stock fair value
   $1.40 - $4.17    $4.85 - $13.91
A summary of option activity under the Plans during the year ended December 31, 2022 is as follows:
 
    
Number of
Options
    
Weighted-
Average
Exercise
Price per
Share
    
Weighted-
Average
Remaining
Contractual
Term (in
Years)
    
Aggregate
Intrinsic
Value
 
                         
(in thousands)
 
Outstanding at January 1, 2022
     7,624,306      $ 14.25        7.5      $ 2,069  
Granted
     3,089,655      $ 2.64        
Exercised
     (293 )     $ 2.71        
Cancelled/Forfeited
     (847,934 )     $ 10.25        
  
 
 
          
Outstanding at December 31, 2022
     9,865,734      $ 10.96        7.2      $ 493  
  
 
 
          
Vested and expected to vest at
December 31, 2022
     9,865,734      $ 10.96        7.2      $ 493  
  
 
 
          
Exercisable at December 31, 2022
     6,111,596      $ 13.19        6.3      $ 493  
  
 
 
          
 
F-2
8

The total intrinsic value of options exercised during the year ended December 31, 2022 and 2021 was immaterial and $0.6 million, respectively. The weighted-average grant date fair value of options granted during the years ended December 31, 2022 and 2021 was $1.68 and $7.26, respectively.
Stock Awards Modifications
As part of the transaction with OXB Solutions (see Note 6), the Company transferred employees to OXB Solutions and modified approximately 1.6 million existing stock options and approximately 0.1 million existing restricted stock units granted to these transferred employees in prior periods in order to permit such individuals to continue vesting in their awards and exercise their vested options as long as they are employed by and provide services to OXB Solutions. The modification of the unvested stock awards to continue vesting was accounted for as a Type III (improbable to probable) modification under FASB ASC Topic 718,
Compensation—Stock Compensation
(“ASC 718”)
.
Accordingly, the Company reversed all compensation cost previously recorded on the awards that were not expected to vest under the original terms. Total compensation cost reversed in the year ended December 31, 2022 was less than $0.1 million. Total compensation cost of $0.8 million, equal to the modification date fair value, will be recognized over the remaining service period. A portion of this total compensation cost will be included as a component of the loss from equity method investment.
The modification of the vested stock awards to permit transferred employees to exercise their options over the remaining life of the award, rather than the
90-day
window for terminated employees, was accounted for as a modification under ASC 718. Accordingly, the Company recognized incremental compensation cost on the modification date in an amount equal to the difference between the fair value of the awards before and after modification. The fair value of the awards immediately before modification assumed a
90-day
expected term, whereas the fair value immediately after assumed an expected term equal to the remaining life of the modified options. Total incremental compensation cost recognized in the year ended December 31, 2022 related to awards that were vested as of the modification date was $0.4 million.
Restricted Stock Units
The fair value of restricted stock units (“RSUs”) is based on the fair market value of the Company’s common stock on the date of grant. Each RSU represents a contingent right to receive one share of the Company’s common stock upon vesting. In general, RSUs vest annually in two or three equal installments on January 1st of each year after the grant date. The following table summarizes the Company’s RSU activity for the year ended December 31, 2022:
 
    
Number of
Restricted
Stock Units
    
Weighted-
Average Grant
Date Fair Value
 
Outstanding at January 1, 2022
     307,600      $ 12.75  
Granted
     400,495      $ 2.70  
Vested
     (106,890 )     $ 12.42  
Forfeited
     (58,026 )     $ 6.05  
  
 
 
    
Outstanding at December 31, 2022
     543,179      $ 6.12  
  
 
 
    
Stock-based Compensation Expense
The Company recognizes compensation expense for awards to employees based on the grant date fair value of stock-based awards on a straight-line basis over the period during which an award holder provides service in
 
F-2
9

exchange for the award, which is generally the vesting period. The Company recorded stock-based compensation expense related to stock options, shares purchased under the 2018 ESPP and restricted stock units as follows:
 
    
For the Year Ended December 31,
 
    
        2022        
    
        2021        
 
    
(in thousands)
 
General and administrative
   $ 7,867      $ 8,450  
Research and development
     5,187        8,795  
  
 
 
    
 
 
 
   $ 13,054      $ 17,245  
  
 
 
    
 
 
 
As of December 31, 2022, there was $14.6 million of unrecognized compensation expense related to unvested employee and
non-employee
share-based compensation arrangements granted under the Plans. The unrecognized compensation expense is estimated to be recognized over a period of 2.3 years at December 31, 2022.
14. DEFINED CONTRIBUTION PLAN
The Company has a 401(k) defined contribution plan (the “401(k) Plan”) for all of its employees. Eligible employees may make pretax contributions to the 401(k) Plan up to statutory limits, while the Company contributes to the plan at the discretion of the Board of Directors. The Company’s discretionary match made under the 401(k) Plan for the years ended December 31, 2022 and 2021 was $0.6 million and $0.8 million, respectively.
15. PFIZER STOCK PURCHASE AGREEMENT
On November 9, 2020, the Company entered into a common stock purchase agreement (the “Stock Purchase Agreement”) with Pfizer Inc. (“Pfizer”), pursuant to which the Company agreed to issue and sell to Pfizer 5,000,000 shares of the Company’s common stock through a private placement transaction (the “Private Placement”) at a purchase price of $12.00 per share, for an aggregate purchase price of $60.0 million. The shares of common stock sold to Pfizer were subject to a
one-year
lock-up
from closing, during which time Pfizer was prohibited from selling or otherwise disposing of such shares.
Under the Stock Purchase Agreement, Pfizer was granted an exclusive right of first refusal (the “ROFR”) for a
30-month
period (the “ROFR Period”) beginning on the date of the closing of the Private Placement (collectively, the “ROFR Provision”), to negotiate a potential collaboration on the development and commercialization of
HMI-102
and
HMI-103.
Pfizer may exercise its right of first refusal under the ROFR Provision one time for each of
HMI-102
and
HMI-103
during the ROFR period. In addition to the ROFR, the Stock Purchase Agreement provides for an information sharing committee (the “Information Committee”), comprised of representatives of each company which will serve as a forum for sharing information regarding the development of
HMI-102
and
HMI-103
during the ROFR Period.
The Company recorded the issuance of common stock at its estimated fair value of $52.0 million, which reflects a discount for the lack of marketability of the shares. The remaining $8.0 million of aggregate purchase price was allocated to the other elements of the Stock Purchase Agreement, which represent a contract with a customer. The Company concluded that the Information Committee represents the only performance obligation under the contract. The ROFR does not provide Pfizer with a material right and is therefore not a performance obligation. As such, the Company allocated the $8.0 million to the Information Committee obligation.
The Company recognizes revenue over time as the measure of progress which it believes best depicts the transfer of control to Pfizer. The Information Committee will meet regularly over the ROFR Period to share information which results in recognition of the transaction price over the
30-month
ROFR Period.
 
F-
30

The Company recognized collaboration revenue of $3.2 million during each of the years ended December 31,
2022
and 2021. As of December 31, 2022 and 2021, there was approximately $1.2 million and $4.4 million of deferred revenue related to the Company’s obligation to Pfizer, respectively.
16. RELATED PARTY TRANSACTIONS
Oxford Biomedica Solutions LLC
As described in Note 6, the Company has significant influence over, but does not control, OXB Solutions through its noncontrolling representation on OXB Solution’s board of directors and the Company’s equity interest in OXB Solutions. In March 2022, concurrently with the closing of the transaction with OXB Solutions, the Company entered into certain ancillary agreements with OXB Solutions including a supply agreement, a lease assignment and assumption agreement, a sublease agreement and a transitional services agreement.
Supply Agreement
Pursuant to the terms of the Manufacturing and Supply Agreement with OXB Solutions entered into in March 2022 (the “Supply Agreement”), the Company has agreed to purchase from OXB Solutions at least 50% of its clinical supply requirements of
AAV-based
products during the initial term of the supply agreement. The Supply Agreement will provide for an initial term of three years, which may be extended for an additional
one-year
term. Under the Supply Agreement, the Company is committed to purchase a minimum number of batches of drug substance and drug product, as well as process development services, totaling approximately $29.7 million in 2023. There are no minimum purchase commitments in 2024 (year three) of the Supply Agreement. After the initial term, the Company will have the right to terminate the Supply Agreement for convenience or other reasons specified in the Supply Agreement upon prior written notice. Either party may terminate the Supply Agreement upon an uncured material breach by the other party or upon the bankruptcy or insolvency of the other party.
During the year ended December 31, 2022, the Company recorded purchases of drug substance from OXB Solutions related to the Supply Agreement of approximately $13.9 million, purchases of process development services of approximately $12.5 million and stability and other support of approximately $1.8 million. These amounts are included within research and development expenses on the Company’s consolidated statements of operations. As of December 31, 2022, the amount due to OXB Solutions under the Supply Agreement was $5.2 million and was included in accrued expenses and other liabilities on the Company’s consolidated balance sheets.
Lease Assignment and Sublease Agreement
As described in Note 9, the Company leases space for research and development, manufacturing and general office space in Bedford, Massachusetts. The Company and OXB Solutions entered into a lease assignment and assumption agreement pursuant to which Homology assigned all of its right, title and interest in, to and under this lease to OXB Solutions and a sublease agreement whereby OXB Solutions subleased certain premises in its facility to Homology. However, as the Company remains jointly and severally liable for the payment of rent under this lease, the Company has not been released from being the primary obligor under such lease and therefore the related
right-of-use
asset and operating lease liability were not derecognized and remain on the Company’s consolidated balance sheets. Therefore, the Company is recording sublease income from OXB Solutions as if it were subleasing the space to OXB Solutions.
During the year ended December 31, 2022, the Company recorded sublease income of $2.0 million related to the sublease agreement with OXB Solutions. This amount was recognized as a reduction to lease expense in the Company’s consolidated statements of operations. As of December 31, 2022, the amount of sublease income receivable from OXB Solutions was $0.5 million and was included in accrued expenses and other liabilities on the Company’s condensed consolidated balance sheets.
 
F-3
1

Transitional Services Agreement
Under the transitional services agreement with OXB Solutions (the “Services Agreement”), the Company is performing certain services for the benefit of OXB Solutions and OXB Solutions is performing certain services for the benefit of the Company. The term of the Services Agreement will not exceed eighteen months and lasts until the earlier of termination for convenience, termination for cause in the event of an uncured material breach, termination as a result of bankruptcy of either party, and expiration or termination of the only remaining outstanding service as set forth in the Services Agreement. Each company is fully reimbursing the other for these services.
Expenses incurred by the Company for services provided by OXB Solutions recognized under the Services Agreement totaled approximately $0.7 million for the year ended December 31, 2022, and is presented within research and development expenses in the consolidated statements of operations as the services related to facilities support within the Company’s research and development labs. As of December 31, 2022, the amount due to OXB Solutions under the Services Agreement was $0.1 million and was included in accrued expenses and other liabilities on the Company’s condensed consolidated balance sheets.
The Company provided finance, human resources, IT and legal services to OXB Solutions under the Services Agreement and recognized $1.7 million for the year ended December 31, 2022, for amounts reimbursed by OXB Solutions as a reduction to general and administrative expense in the Company’s consolidated statements of operations. As of December 31, 2022, the Company had a receivable balance of $0.3 million from OXB Solutions which was recorded as a component of prepaid expenses and other current assets in the Company’s condensed consolidated balance sheets. Pursuant to the Services Agreement, the Company has been paying vendors on OXB Solutions’ behalf; this process will be fully transitioned to OXB Solutions in 2023. As of December 31, 2022, the amount receivable from OXB Solutions for amounts paid to vendors on their behalf was $1.1 million and was included in prepaid expenses and other current assets on the Company’s consolidated balance sheets. In addition, the Company had an amount due to OXB Solutions of $2.0 million as a result of a
year-end
reconciliation between the two companies related to vendor invoicing.
 
F-3
2

HOMOLOGY MEDICINES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts)
(UNAUDITED)
 
    
As of
 
    
September 30,
2023
   
December 31,
2022
 
Assets
    
Current assets:
    
Cash and cash equivalents
   $ 29,111     $ 33,986  
Short-term investments
     74,187       141,040  
Assets held for sale
     314       —    
Prepaid expenses and other current assets
     3,023       5,989  
  
 
 
   
 
 
 
Total current assets
     106,635       181,015  
Equity method investment
     13,957       25,814  
Property and equipment, net
     —         1,078  
Right-of-use
assets
     19,471       20,563  
  
 
 
   
 
 
 
Total assets
   $ 140,063     $ 228,470  
  
 
 
   
 
 
 
Liabilities and stockholders’ equity
    
Current liabilities:
    
Accounts payable
   $ 7,803     $ 1,144  
Accrued expenses and other liabilities
     15,711       18,715  
Operating lease liabilities
     1,778       1,561  
Deferred revenue
     —         1,156  
  
 
 
   
 
 
 
Total current liabilities
     25,292       22,576  
Non-current
liabilities:
    
Operating lease liabilities, net of current portion
     26,560       27,916  
  
 
 
   
 
 
 
Total liabilities
     51,852       50,492  
  
 
 
   
 
 
 
Commitments and contingencies (Note 9)
       —    
Stockholders’ equity:
    
Preferred stock, $0.0001 par value, 10,000,000 shares authorized; no shares issued and outstanding at September 30, 2023 and December 31, 2022
     —         —    
Common stock, $0.0001 par value; 200,000,000 shares authorized; 57,902,210 and 57,483,910 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively
     6       6  
Additional
paid-in
capital
     614,220       607,513  
Accumulated other comprehensive loss
     (36 )      (404 ) 
Accumulated deficit
     (525,979 )      (429,137 ) 
  
 
 
   
 
 
 
Total stockholders’ equity
     88,211       177,978  
  
 
 
   
 
 
 
Total liabilities and stockholders’ equity
   $ 140,063     $ 228,470  
  
 
 
   
 
 
 
See notes to condensed consolidated financial statements.
 
F-3
3

HOMOLOGY MEDICINES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
(UNAUDITED)
 
   
Three months ended
September 30,
   
Nine months ended
September 30,
 
   
2023
   
2022
   
2023
   
2022
 
Collaboration revenue
  $ —       $ 802     $ 1,156     $ 2,406  
Operating expenses:
       
Research and development
    17,519       25,854       60,489       71,202  
General and administrative
    6,842       7,810       23,355       29,991  
Restructuring and other charges
    6,640       —         6,640       —    
 
 
 
   
 
 
   
 
 
   
 
 
 
Total operating expenses
    31,001       33,664       90,484       101,193  
 
 
 
   
 
 
   
 
 
   
 
 
 
Loss from operations
    (31,001 )      (32,862 )      (89,328 )      (98,787 ) 
 
 
 
   
 
 
   
 
 
   
 
 
 
Other income:
       
Gain on sale of business
    —         —         —         131,249  
Interest income
    1,423       1,269       4,403       1,775  
 
 
 
   
 
 
   
 
 
   
 
 
 
Total other income
    1,423       1,269       4,403       133,024  
 
 
 
   
 
 
   
 
 
   
 
 
 
Income (loss) before income taxes
    (29,578 )      (31,593 )      (84,925 )      34,237  
 
 
 
   
 
 
   
 
 
   
 
 
 
Benefit from (provision for) income taxes
    —         46       —         (816 ) 
Loss from equity method investment
    (3,376 )      (2,179 )      (11,917 )      (4,131 ) 
 
 
 
   
 
 
   
 
 
   
 
 
 
Net income (loss)
  $ (32,954 )    $ (33,726 )    $ (96,842 )    $ 29,290  
 
 
 
   
 
 
   
 
 
   
 
 
 
Net income (loss) per share-basic
  $ (0.57 )    $ (0.59 )    $ (1.68 )    $ 0.51  
 
 
 
   
 
 
   
 
 
   
 
 
 
Net income (loss) per share-diluted
  $ (0.57 )    $ (0.59 )    $ (1.68 )    $ 0.51  
 
 
 
   
 
 
   
 
 
   
 
 
 
Weighted-average common shares outstanding-basic
    57,853,132       57,447,192       57,788,755       57,372,399  
Weighted-average common shares outstanding-diluted
    57,853,132       57,447,192       57,788,755       57,901,298  
See notes to condensed consolidated financial statements.
 
F-3
4

HOMOLOGY MEDICINES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(in thousands)
(UNAUDITED)
 
    
Three months ended
September 30,
   
Nine months ended
September 30,
 
    
2023
   
2022
   
2023
   
2022
 
Net income (loss)
   $ (32,954 )    $ (33,726 )    $ (96,842 )    $ 29,290  
Other comprehensive gain (loss):
        
Change in unrealized gain (loss) on available for sale securities, net
     52       (416 )      368       (450 ) 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total other comprehensive gain (loss)
     52       (416 )      368       (450 ) 
  
 
 
   
 
 
   
 
 
   
 
 
 
Comprehensive income (loss)
   $ (32,902 )    $ (34,142 )    $ (96,474 )    $ 28,840  
  
 
 
   
 
 
   
 
 
   
 
 
 
See notes to condensed consolidated financial statements.
 
F-3
5

HOMOLOGY MEDICINES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands, except share and per share amounts)
(UNAUDITED)
 
    
Common Stock
$0.0001 Par Value
    
Additional
Paid-in
    
Accumulated
Other
Comprehensive
   
Accumulated
   
Total
Stockholders’
 
    
Shares
    
Amount
    
Capital
    
Gain (Loss)
   
Deficit
   
Equity
 
Balance at January 1, 2022
     57,150,274      $ 6      $ 593,784      $ (7 )    $ (424,132 )    $ 169,651  
Issuance of common stock from RSU vesting
     87,140        —          —          —         —         —    
Issuance of common stock from option exercises
     293        —          1        —         —         1  
Issuance of common stock pursuant to employee stock purchase plan
     147,871        —          439        —         —         439  
Stock-based compensation
     —          —          4,051        —         —         4,051  
Other comprehensive gain
     —          —          —          7       —         7  
Net income
     —          —          —          —         92,105       92,105  
  
 
 
    
 
 
    
 
 
    
 
 
   
 
 
   
 
 
 
Balance at March 31, 2022
     57,385,578      $ 6      $ 598,275      $ —       $ (332,027 )    $ 266,254  
Stock-based compensation
     —          —          3,143        —         —         3,143  
Stock-based compensation for equity method investee
     —          —          21        —         —         21  
Other comprehensive loss
     —          —          —          (41 )      —         (41 ) 
Net loss
     —          —          —          —         (29,089 )      (29,089 ) 
  
 
 
    
 
 
    
 
 
    
 
 
   
 
 
   
 
 
 
Balance at June 30, 2022
     57,385,578      $ 6      $ 601,439      $ (41 )    $ (361,116 )    $ 240,288  
Issuance of common stock from RSU vesting
     16,450        —          —          —         —         —    
Issuance of common stock pursuant to employee stock purchase plan
     78,582        —          124        —         —         124  
Stock-based compensation
     —          —          2,771        —         —         2,771  
Stock-based compensation for equity method investee
     —          —          20        —         —         20  
Other comprehensive loss
     —          —          —          (416 )      —         (416 ) 
Net loss
     —          —          —          —         (33,726 )      (33,726 ) 
  
 
 
    
 
 
    
 
 
    
 
 
   
 
 
   
 
 
 
Balance at September 30, 2022
     57,480,610      $ 6      $ 604,354      $ (457 )    $ (394,842 )    $ 209,061  
  
 
 
    
 
 
    
 
 
    
 
 
   
 
 
   
 
 
 
 
F-3
6

    
Common Stock
$0.0001 Par Value
    
Additional
Paid-in
    
Accumulated
Other
Comprehensive
   
Accumulated
   
Total
Stockholders’
 
    
Shares
    
Amount
    
Capital
    
Gain (Loss)
   
Deficit
   
Equity
 
Balance at January 1, 2023
     57,483,910      $ 6      $ 607,513      $ (404 )    $ (429,137 )    $ 177,978  
Issuance of common stock from RSU vesting
     194,525        —          —          —         —         —    
Issuance of common stock pursuant to employee stock purchase plan
     116,332        —          150        —         —         150  
Stock-based compensation
     —          —          2,369        —         —         2,369  
Stock-based compensation for equity method investee
     —          —          24        —         —         24  
Other comprehensive gain
     —          —          —          222       —         222  
Net loss
     —          —          —          —         (28,844 )      (28,844 ) 
  
 
 
    
 
 
    
 
 
    
 
 
   
 
 
   
 
 
 
Balance at March 31, 2023
     57,794,767      $ 6      $ 610,056      $ (182 )    $ (457,981 )    $ 151,899  
Issuance of common stock from option exercises
     3,366        —          2        —         —         2  
Stock-based compensation
     —          —          2,402        —         —         2,402  
Stock-based compensation for equity method investee
     —          —          22        —         —         22  
Other comprehensive gain
     —          —          —          94       —         94  
Net loss
     —          —          —          —         (35,044 )      (35,044 ) 
  
 
 
    
 
 
    
 
 
    
 
 
   
 
 
   
 
 
 
Balance at June 30, 2023
     57,798,133      $ 6      $ 612,482      $ (88 )    $ (493,025 )    $ 119,375  
Issuance of common stock from RSU vesting
     86,592        —          —          —         —         —    
Issuance of common stock pursuant to employee stock purchase plan
     17,485        —          18        —         —         18  
Stock-based compensation
     —          —          1,706        —         —         1,706  
Stock-based compensation for equity method investee
     —          —          14        —         —         14  
Other comprehensive gain
     —          —          —          52       —         52  
Net loss
     —          —          —          —         (32,954 )      (32,954 ) 
  
 
 
    
 
 
    
 
 
    
 
 
   
 
 
   
 
 
 
Balance at September 30, 2023
     57,902,210      $ 6      $ 614,220      $ (36 )    $ (525,979 )    $ 88,211  
  
 
 
    
 
 
    
 
 
    
 
 
   
 
 
   
 
 
 
See notes to condensed consolidated financial statements.
 
F-3
7

HOMOLOGY MEDICINES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(UNAUDITED)
 
    
Nine months ended
September 30,
 
    
2023
   
2022
 
Cash flows from operating activities:
    
Net income (loss)
   $ (96,842 )    $ 29,290  
Adjustments to reconcile net loss to net cash used in operating activities:
    
Depreciation
     578       997  
Noncash lease expense
     1,091       969  
Loss from equity method investment
     11,917       4,131  
Stock-based compensation expense
     6,477       9,965  
Accretion of discount on short-term investments
     (2,279 )      (872 ) 
Loss on disposal of property and equipment
     68       —    
Gain on sale of business
     —         (131,249 ) 
Changes in operating assets and liabilities:
    
Prepaid expenses and other current assets
     2,966       (5,301 ) 
Accounts payable
     6,659       2,711  
Accrued expenses and other liabilities
     (2,996 )      5,672  
Deferred revenue
     (1,156 )      (2,406 ) 
Operating lease liabilities
     (1,138 )      (369 ) 
  
 
 
   
 
 
 
Net cash used in operating activities
     (74,655 )      (86,462 ) 
  
 
 
   
 
 
 
Cash flows from investing activities:
    
Purchases of short-term investments
     (73,240 )      (157,460 ) 
Maturities of short-term investments
     142,740       47,461  
Proceeds from sale of business
     —         130,000  
Proceeds from sale of property and equipment
     338       —    
Purchases of property and equipment
     (228 )      (1,276 ) 
  
 
 
   
 
 
 
Net cash provided by investing activities
     69,610       18,725  
  
 
 
   
 
 
 
Cash flows from financing activities:
    
Proceeds from issuance of common stock pursuant to employee
stock purchase plan
     168       563  
Proceeds from issuance of common stock from option exercises
     2       1  
  
 
 
   
 
 
 
Net cash provided by financing activities
     170       564  
  
 
 
   
 
 
 
Net change in cash, cash equivalents and restricted cash
     (4,875 )      (67,173 ) 
Cash, cash equivalents and restricted cash, beginning of period
     33,986       110,335  
  
 
 
   
 
 
 
Cash, cash equivalents and restricted cash, end of period
   $ 29,111     $ 43,162  
  
 
 
   
 
 
 
Supplemental disclosures of noncash investing and financing activities:
    
Property and equipment additions included in accrued expenses and other liabilities
   $ —       $ 8  
  
 
 
   
 
 
 
Unrealized gain (loss) on available for sale securities, net
   $ 368     $ (450 ) 
  
 
 
   
 
 
 
See notes to condensed consolidated financial statements.
 
F-3
8

HOMOLOGY MEDICINES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
(UNAUDITED)
1. NATURE OF BUSINESS AND BASIS OF PRESENTATION
Nature of Business
—Homology Medicines, Inc. (the “Company” or “Homology”) is a clinical-stage genetic medicines company historically focused on transforming the lives of patients suffering from rare diseases by addressing the underlying cause of the disease with
one-time
gene therapy and gene editing treatments. The Company was founded in March 2015 as a Delaware corporation. Its principal offices are in Bedford, Massachusetts.
On July 27, 2023, the Company announced that it had completed a review of its business and the Company’s Board of Directors had approved a plan to explore, review and evaluate a range of potential strategic options available to the Company, including, without limitation, an acquisition, merger, reverse merger, sale of assets, strategic partnerships or other transactions. Based on the current financing environment and the Company’s anticipated clinical development timeline for its lead program,
HMI-103,
the Company also announced that it was stopping further development of its programs and reduced its workforce by 86% in an effort to significantly reduce its ongoing operating costs as it evaluates strategic alternatives. The workforce reduction was substantially completed in the third quarter of 2023 (see Note 8).
On March 9, 2023, the Company filed a Registration Statement on Form
S-3
(File
No. 333-270414)
(the “Shelf”) with the SEC in relation to the registration of up to an aggregate of $250.0 
million of its common stock, preferred stock, debt securities, warrants and/or units of any combination thereof for a period up to three years from the date of the filing. The Shelf became effective on March 17, 2023. The Company also simultaneously entered into a sales agreement with TD Cowen, as sales agent, providing for the offering, issuance and sale by the Company of up to an aggregate of $
75.0 million of its common stock from time to time in
“at-the-market”
offerings under the Shelf (the “ATM”). The Company did not sell any shares of common stock under the ATM during the nine months ended September 30, 2023. As of September 30, 2023, there remained $75.0 million of common stock available for sale under the ATM.
On March 10, 2022, the Company closed a transaction with Oxford Biomedica plc (“Oxford”), to establish a new adeno-associated virus (“AAV”) vector manufacturing company, Oxford Biomedica Solutions (“OXB Solutions”) that provides AAV vector process development and manufacturing services to biotechnology companies. Under the terms of the agreement, the Company contributed its manufacturing team of 125 employees, manufacturing facility and equipment, manufacturing-related intellectual property and
know-how
and certain other assets. Oxford paid the Company $130.0 million of upfront cash and invested $50.0 million of cash to fund OXB Solutions in exchange for an 80 percent ownership interest, while Homology retained a 20 percent ownership interest in the new company and received a put option on this ownership position (see Note 5).
Since its inception and until recently, the Company devoted substantially all of its resources to recruiting personnel, developing its technology platform and advancing its pipeline of product candidates through discovery, preclinical and clinical trials, developing and implementing manufacturing processes, building out manufacturing and research and development space, and maintaining and building its intellectual property portfolio. The Company is subject to a number of risks similar to those of other companies conducting high-risk, early-stage research and development of product candidates. Principal among these risks are dependency on key individuals and intellectual property, competition from other products and companies, and the technical and regulatory risks associated with the successful research, development and manufacturing of its product candidates.
 
F-3
9

To date, the Company has not generated any revenue from product sales and does not expect to generate any revenue from the sale of product in the foreseeable future. Through September 30, 2023, the Company has financed its operations primarily through public offerings of its common stock, the issuance of convertible preferred stock, and with proceeds from its transaction with Oxford (see Note 5), its collaboration and license agreement with a former collaboration partner and its private placement with Pfizer (see Note 12). During the nine months ended September 30, 2023, the Company incurred a loss from operations of $96.8 million and as of September 30, 2023, the Company had $526.0 million in accumulated deficit.
The Company has incurred and expects to continue to incur costs and expenditures in connection with the process of evaluating strategic alternatives. There can be no assurance, however, that the Company will be able to successfully consummate any particular strategic transaction. The process of evaluating strategic options has been and may continue to be costly, time-consuming and complex and the Company may incur significant costs related to this continued evaluation, such as legal, accounting and advisory fees and expenses and other related charges.
Based on current projections, management believes that the Company’s existing cash and cash equivalents and short-term investments as of September 30, 2023 will enable the Company to continue its operations for at least one year from the date of this filing. However, due to the consideration of certain qualitative factors, including the discontinuation of all clinical trials and research activities, as well as the Company’s workforce reduction of all but a few custodial employees, management has concluded there is substantial doubt regarding the Company’s ability to continue as a going concern for more than twelve months from the issuance date of the unaudited condensed consolidated financial statements for the period ended September 30, 2023. These financial statements do not include any adjustments that might result from the outcome of this uncertainty. Should the Company resume the development of product candidates, it would need to obtain substantial additional funding in connection with continuing operations, particularly as the Company resumes its preclinical activities and clinical trials for its product candidates. There can be no assurance that the Company will be able
to o
btain sufficient capital to cover its costs on acceptable terms, if at all.
Basis of Presentation
— The accompanying unaudited condensed consolidated financial statements have been prepared by the Company in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the rules and regulations of the SEC for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2022, included in the Company’s
audited consolidated financial statements and the notes thereto for the year ended December 31, 2022, included elsewhere in this proxy/registration statement.
The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements. In the opinion of management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments which are necessary for a fair statement of the Company’s financial position as of September 30, 2023, and consolidated results of operations for the three and nine months ended September 30, 2023 and 2022, and cash flows for the nine months ended September 30, 2023 and 2022. Such adjustments are of a normal and recurring nature. The results of operations for the three and nine months ended September 30, 2023 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2023.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Principles of Consolidation
—The Company’s condensed consolidated financial statements include the accounts of the Company and its subsidiary, Homology Medicines Securities Corporation, a wholly owned Massachusetts corporation, for the sole purpose of buying, selling, and holding securities on the Company’s
 
F-
40

behalf. All intercompany balances and transactions have been eliminated in the condensed consolidated financial statements.
Use of Estimates
—The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, and expenses, and the disclosure of contingent assets and liabilities as of and during the reporting period. The Company bases its estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, revenue recognition, accrued research and development expenses and the valuation of the Company’s equity method investment. The Company assesses estimates on an ongoing basis; however, actual results could materially differ from those estimates.
Comprehensive Income (Loss)
—Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from
non-owner
sources. The Company’s only element of other comprehensive income (loss) is unrealized gains and losses on
available-for-sale
investments.
Cash and Cash Equivalents and Restricted Cash
—Cash and cash equivalents consist of standard checking accounts, money market accounts and certain investments. The Company considers all highly liquid investments with original or remaining maturities at the time of purchase of 90 days or less to be cash equivalents. The Company did not have any restricted cash at September 30, 2023 or December 31, 2022.
Short-Term Investments
—Short-term investments represent holdings of
available-for-sale
marketable securities in accordance with the Company’s investment policy and cash management strategy. Short-term investments have maturities of greater than 90 days at the time of purchase and mature within one year from the balance sheet date. Investments in marketable securities are recorded at fair value, with any unrealized gains and losses reported within accumulated other comprehensive income as a separate component of stockholders’ equity until realized or until a determination is made that an other-than-temporary decline in market value has occurred. Any premium or discount arising at purchase is amortized and/or accreted to interest income and/or expense over the life of the underlying security. Such amortization and accretion, together with interest on securities, are included in interest income in the Company’s condensed consolidated statements of operations. The cost of marketable securities sold is determined based on the specific identification method and any realized gains or losses on the sale of investments are reflected as a component of other income.
Assets Held for Sale
—The Company classifies assets as held for sale when the following conditions are met: (1) management has committed to a plan to sell, (2) the assets are available for immediate sale in their present condition, (3) the Company has initiated an active program to identify a buyer, (4) it is probable that a sale will occur within one year, (5) the assets are actively marketed for sale at a reasonable price in relation to their current fair value, and (6) there is a low likelihood of significant changes to the plan or that the plan will be withdrawn. If all of the aforementioned criteria are met as of the balance sheet date, the assets are presented separately in the consolidated balance sheet as held for sale at the lower of the carrying amount or fair value less costs to sell. The assets are then no longer depreciated or amortized while classified as held for sale
.
Equity Method Investment
—The Company uses the equity method of accounting to account for an investment in an entity that it does not control, but in which it has the ability to exercise significant influence over operating and financial policies. The Company’s proportionate share of the net income or loss of the entity is included in consolidated net loss. Judgments regarding the level of influence over the equity method investment include consideration of key factors such as the Company’s ownership interest, representation on the board of directors or other management body and participation in policy-making decisions.
Under the equity method of accounting, the Company’s investment is initially recorded at fair value on the condensed consolidated balance sheets. Upon initial investment, the Company evaluates whether there are basis
 
F-4
1

differences between the carrying value and fair value of the Company’s proportionate share of the investee’s underlying net assets. Typically, the Company amortizes basis differences identified on a straight-line basis over the underlying assets’ estimated useful lives when calculating the attributable earnings or losses, excluding the basis differences attributable to
in-process
research and development that has no alternative future use. If the Company is unable to attribute all of the basis differences to specific assets or liabilities of the investee, the residual excess of the cost of the investment over the proportional fair value of the investee’s assets and liabilities is considered to be equity method goodwill and is recognized within the equity investment balance, which is tracked separately within the Company’s memo accounts. The Company subsequently records in the condensed consolidated statements of operations its share of income or loss of the other entity within other income/expense, which results in an increase or decrease to the carrying value of the investment. If the share of losses exceeds the carrying value of the Company’s investment, the Company will suspend recognizing additional losses and will continue to do so unless it commits to providing additional funding; however, if there are intra-entity profits this can cause the investment balance to go negative.
The Company evaluates its equity method investments for impairment whenever events or changes in circumstances indicate that a decline in value has occurred that is other than temporary. Evidence considered in this evaluation includes, but would not necessarily be limited to, the financial condition and near-term prospects of the investee, recent operating trends and forecasted performance of the investee, market conditions in the geographic area or industry in which the investee operates and the Company’s strategic plans for holding the investment in relation to the period of time expected for an anticipated recovery of its carrying value. If the investment is determined to have a decline in value deemed to be other than temporary it is written down to estimated fair value.
At September 30, 2023, the Company accounted for its investment in OXB Solutions using the equity method of accounting (see Note 5).
Offering Costs
—The Company capitalizes incremental legal, professional accounting and other third-party fees that are directly associated with equity financings as other current assets until the transactions are completed. After equity financings are complete, these costs are recorded in stockholders’ equity as a reduction of additional
paid-in
capital generated as a result of the offering.
Leases
—The Company determines if an arrangement is a lease at contract inception. The Company’s contracts are determined to contain a lease when all of the following criteria based on the specific circumstances of the arrangement are met: (1) there is an identified asset for which there are no substantive substitution rights; (2) the Company has the right to obtain substantially all of the economic benefits from the identified asset; and (3) the Company has the right to direct the use of the identified asset.
At the commencement date, operating lease liabilities and their corresponding
right-of-use
assets are recorded based on the present value of future lease payments over the expected lease term. The Company’s lease agreements do not provide an implicit rate. As a result, the Company utilizes an estimated incremental borrowing rate to discount lease payments, which is based on the rate of interest the Company would have to pay to borrow a similar amount on a collateralized basis over a similar term. Certain adjustments to the
right-of-use
asset may be required for items such as initial direct costs paid or lease incentives received. Operating lease cost is recognized over the expected term on a straight-line basis. The expected lease term includes noncancelable lease periods and, when applicable, periods covered by an option to extend the lease if the Company is reasonably certain to exercise that option, as well as periods covered by an option to terminate the lease if the Company is reasonably certain not to exercise that option. Variable lease cost is recognized as incurred.
Right-of-use
assets are periodically evaluated for impairment.
The Company acts as sublessor related to a sublease of a substantial portion of the Company’s headquarters that is now occupied by OXB Solutions. Fixed sublease payments received are recorded as a reduction to lease cost. Although Homology assigned all of its right, title and interest in, to and under this lease to OXB Solutions,
 
F-4
2

the Company remained jointly and severally liable for the payment of rent under this lease as of and for the three and nine months ended September 30, 2023. Therefore, the related
right-of-use
asset and operating lease liability were not derecognized and remained on the Company’s condensed consolidated balance sheets as of September 30, 2023. The Company was released from being the primary obligor under such lease effective October 1, 2023 (see Note 14).
Research and Development Costs
—Research and development costs are charged to expense as incurred. Research and development expense consists of expenses incurred in performing research and development activities, including salaries and benefits, materials and supplies, preclinical and clinical expenses, stock-based compensation expense, depreciation of equipment, contract services, and other outside expenses.
Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasks using information provided to the Company by its vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the consolidated financial statements as prepaid expense or accrued research and development expense.
Income Taxes—
The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the Company’s condensed consolidated financial statements and tax returns. Deferred tax assets and liabilities are determined based upon the differences between the financial statement carrying amounts and the tax bases of existing assets and liabilities and for loss and credit carryforwards, using enacted tax rates expected to be in effect in the year in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if it is more likely than not that these assets may not be realized. The Company determines whether it is more likely than not that a tax position will be sustained upon examination. The tax benefit to be recognized for any tax position that meets the
more-likely-than-not
recognition threshold is calculated as the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement. If it is not more likely than not that a position will be sustained, none of the benefit attributable to the position is recognized.
The Company accounts for interest and penalties related to uncertain tax positions as part of its provision for income taxes. Since inception, the Company has provided a valuation allowance for the full amount of the net deferred tax assets as the realization of the net deferred tax assets has not been determined to be more likely than not.
The Company recorded an income tax benefit of less than $0.1 million and an income tax provision of $0.8 million for the three and nine months ended September 30, 2022, respectively. The
year-to-date
tax provision predominately resulted from the gain associated with the sale of the Company’s manufacturing business due to the transaction with Oxford (see Note 5), offset by available federal and state net operating loss carryforwards and research and development tax credits which are subject to certain limitations as to their utilization. The Company did not record an income tax provision (benefit) for the three and nine months ended September 30, 2023.
Revenue Recognition—
Revenue is recognized in accordance with FASB Accounting Standards Codification (“ASC”) Topic 606,
Revenue from Contracts with Customers
(“ASC 606”).
Under ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine the appropriate amount of revenue to be recognized for arrangements determined to be within the scope of ASC 606, the Company performs the following five steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect consideration it is entitled to in exchange for the goods or services it transfers to the customer.
 
F-4
3

The promised goods or services in the Company’s arrangements would likely consist of a license, rights to the Company’s intellectual property or research, development and manufacturing services. Performance obligations are promised goods or services in a contract to transfer a distinct good or service to the customer and are considered distinct when (i) the customer can benefit from the good or service on its own or together with other readily available resources and (ii) the promised good or service is separately identifiable from other promises in the contract. In assessing whether promised goods or services are distinct, the Company considers factors such as the stage of development of the underlying intellectual property, the capabilities of the customer to develop the intellectual property on its own or whether the required expertise is readily available and whether the goods or services are integral or dependent to other goods or services in the contract.
The Company estimates the transaction price based on the amount expected to be received for transferring the promised goods or services in the contract. The consideration may include fixed consideration and variable consideration. At the inception of each arrangement that includes variable consideration, the Company evaluates the amount of consideration to which the Company expects to be entitled to. The Company utilizes either the most likely amount method or expected value method to estimate the amount expected to be received based on which method best predicts the amount expected to be received. The amount of variable consideration that is included in the transaction price may be constrained and is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period.
The Company’s contracts may include development and regulatory milestone payments that are assessed under the most likely amount method and constrained until it is probable that a significant revenue reversal would not occur. Milestone payments that are not within the Company’s control, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. At the end of each reporting period, the Company
re-evaluates
the probability of achievement of such development and regulatory milestones and any related constraint, and if necessary, adjust its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative
catch-up
basis, which would affect collaboration revenue in the period of adjustment.
For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from the Company’s collaboration arrangement.
The Company allocates the transaction price based on the estimated standalone selling price of each performance obligation. The Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. The Company utilizes key assumptions to determine the stand-alone selling price, which may include other comparable transactions, pricing considered in negotiating the transaction and the estimated costs. Variable consideration is allocated specifically to one or more performance obligations in a contract when the terms of the variable consideration relate to the satisfaction of the performance obligation and the resulting amounts allocated are consistent with the amounts the Company would expect to receive for the satisfaction of each performance obligation.
The consideration allocated to each performance obligation is recognized as revenue when control is transferred for the related goods or services. For performance obligations which consist of licenses and other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress. The Company evaluates the measure of progress for its over-time arrangements at each reporting period and, if necessary, updates the measure of progress and revenue recognized.
 
F-4
4

Net Income (Loss) per Share—
Basic net income (loss) per share is computed by dividing net income (loss) by the weighted-average number of common shares outstanding during the period. Diluted net income (loss) per share is computed using the weighted-average number of common shares outstanding during the period and, if dilutive, the weighted-average number of potential shares of common stock. The weighted-average number of common shares included in the computation of diluted net income (loss) gives effect to all potentially dilutive common equivalent shares, including outstanding stock options, restricted stock units and unvested shares of common stock.
Common stock equivalent shares are excluded from the computation of diluted net income (loss) per share if their effect is antidilutive. In periods in which the Company reports a net (loss) attributable to common stockholders, diluted net (loss) per share attributable to common stockholders is generally the same as basic net (loss) per share attributable to common stockholders, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive.
Recent Accounting Pronouncements
—The Jumpstart Our Business Startups Act of 2012 permits an emerging growth company to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. As an emerging growth company, the Company has elected to take advantage of this extended transition period.
In June 2016, the FASB issued ASU
No. 2016-13,
Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments
(“ASU
2016-13”)
to improve financial reporting by requiring more timely recording of credit losses on loans and other financial instruments held by financial institutions and other organizations. ASU
2016-13
requires the measurement of all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. ASU
2016-13
also requires enhanced disclosures to help investors and other financial statement users better understand significant estimates and judgments used in estimating credit losses, as well as the credit quality and underwriting standards of an organization’s portfolio. The Company adopted ASU
2016-13
on January 1, 2023. The adoption of ASU
2016-13
did not have a material impact on the Company’s condensed consolidated financial statements and related disclosures.
3. SHORT-TERM INVESTMENTS
The Company may invest its excess cash in fixed income instruments denominated and payable in U.S. dollars, including U.S. treasury securities, commercial paper, corporate debt securities and asset-backed securities in accordance with the Company’s investment policy that primarily seeks to maintain adequate liquidity and preserve capital.
The following table summarizes the Company’s short-term investments as of September 30, 2023 and December 31, 2022:
 
As of September 30, 2023
  
Amortized
Cost
    
Unrealized
Gains
    
Unrealized
Losses
    
Fair
Value
 
    
(in thousands)
 
Commercial paper
   $ 3,965      $ —        $ (2 )     $ 3,963  
US Treasury securities
     55,268        6        (7 )       55,267  
Corporate debt securities
     14,990        —          (33 )       14,957  
  
 
 
    
 
 
    
 
 
    
 
 
 
Total
   $ 74,223      $ 6      $ (42 )     $ 74,187  
  
 
 
    
 
 
    
 
 
    
 
 
 
 
F-4
5

As of December 31, 2022
  
Amortized
Cost
    
Unrealized
Gains
    
Unrealized
Losses
    
Fair Value
 
    
(in thousands)
 
Commercial paper
   $ 57,138      $ —        $ —        $ 57,138  
US Treasury securities
     65,160        —          (335 )       64,825  
Corporate debt securities
     19,146        —          (69 )       19,077  
  
 
 
    
 
 
    
 
 
    
 
 
 
Total
   $ 141,444      $ —        $ (404 )     $ 141,040  
  
 
 
    
 
 
    
 
 
    
 
 
 
The Company utilizes the specific identification method in computing realized gains and losses. The Company had no realized gains and losses on its
available-for-sale
securities for the three and nine months ended September 30, 2023 and 2022. The contractual maturity dates of all of the Company’s investments are less than one year.
4. FAIR VALUE MEASUREMENTS
The Company’s financial instruments consist of cash and cash equivalents, short-term investments, restricted cash and accounts payable. The carrying amount of cash, restricted cash and accounts payable are each considered a reasonable estimate of fair value due to the short-term maturity.
Assets measured at fair value on a recurring basis were as follows:
 
Description
  
September 30,
2023
    
Quoted Prices
(Unadjusted) in
Active Markets
for Identical
Assets
(Level 1)
    
Significant Other
Observable
Inputs
(Level 2)
    
Significant
Unobservable
Inputs
(Level 3)
 
    
(in thousands)
 
Cash equivalents:
           
Money market mutual funds
   $ 28,375      $ 28,375      $ —        $ —    
  
 
 
    
 
 
    
 
 
    
 
 
 
Total cash equivalents
   $ 28,375      $ 28,375      $ —        $ —    
  
 
 
    
 
 
    
 
 
    
 
 
 
Short-term investments:
           
Commercial paper
   $ 3,963      $ —        $ 3,963      $ —    
US Treasury securities
     55,267        —          55,267        —    
Corporate debt securities
     14,957        —          14,957        —    
  
 
 
    
 
 
    
 
 
    
 
 
 
Total
short-term
investments
   $ 74,187      $ —        $ 74,187      $ —    
  
 
 
    
 
 
    
 
 
    
 
 
 
Total financial assets
   $ 102,562      $ 28,375      $ 74,187      $ —    
  
 
 
    
 
 
    
 
 
    
 
 
 
 
Description
  
December 31,
2022
    
Quoted Prices
(Unadjusted) in
Active Markets
for Identical
Assets
(Level 1)
    
Significant Other
Observable
Inputs
(Level 2)
    
Significant
Unobservable
Inputs
(Level 3)
 
    
(in thousands)
 
Cash equivalents:
           
Money market mutual funds
   $ 33,967      $ 33,967      $ —        $ —    
  
 
 
    
 
 
    
 
 
    
 
 
 
Total cash equivalents
   $ 33,967      $ 33,967      $ —        $ —    
  
 
 
    
 
 
    
 
 
    
 
 
 
Short-term investments:
           
Commercial paper
   $ 57,138      $ —        $ 57,138      $ —    
US Treasury securities
     64,825        —          64,825        —    
Corporate debt securities
     19,077        —          19,077        —    
  
 
 
    
 
 
    
 
 
    
 
 
 
Total short-term investments
   $ 141,040      $ —        $ 141,040      $ —    
  
 
 
    
 
 
    
 
 
    
 
 
 
Total financial assets
   $ 175,007      $ 33,967      $ 141,040      $ —    
  
 
 
    
 
 
    
 
 
    
 
 
 
 
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Short-term securities are valued using models or other valuation methodologies that use Level 2 inputs. These models are primarily industry-standard models that consider various assumptions, including time value, yield curve, volatility factors, default rates, current market and contractual prices for the underlying financial instruments, as well as other relevant economic measures. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace.
There were no transfers between fair value measurement levels during the three and nine months ended September 30, 2023 and 2022.
5. EQUITY METHOD INVESTMENT
Summary of Transaction
On March 10, 2022, the Company closed a transaction with OXB Solutions, Oxford Biomedica (US), Inc., (“OXB”), and Oxford, pursuant to the Equity Securities Purchase Agreement (the “Purchase Agreement”), dated as of January 28, 2022, by and among Homology, OXB Solutions and Oxford, whereby, among other things, Homology and Oxford agreed to collaborate to operate OXB Solutions, which provides AAV vector process development and manufacturing services to pharmaceutical and biotechnology companies (the “OXB Solutions Transaction”).
Pursuant to the terms of the Purchase Agreement and a contribution agreement (the “Contribution Agreement”) entered into between Homology and OXB Solutions prior to the closing of the OXB Solutions Transaction (the “Closing”), Homology contributed its manufacturing team of 125 employees and assigned and transferred to OXB Solutions all of its assets that are primarily used in the manufacturing of AAV vectors for use in gene therapy and gene editing products, including its manufacturing facility and equipment and manufacturing-related intellectual property and
know-how,
but excluding certain assets related to manufacturing or testing of Homology’s proprietary AAV vectors (collectively, the “Transferred Assets”), in exchange for 175,000 common equity units in OXB Solutions (“Units”), representing 100 percent (100%) of the ownership interest of OXB Solutions, and OXB Solutions assumed from the Company, and agreed to pay, perform and discharge when due, all of the Company’s duties, obligations, liabilities, interests and commitments of any kind under, arising out of or relating to the Transferred Assets.
Effective as of the Closing, Homology sold to OXB, and OXB purchased from Homology, 130,000 Units, (the “Transferred Units”) in exchange for $130.0 million of cash consideration. In connection with the Closing, OXB contributed $50.0 million in cash to OXB Solutions in exchange for an additional, newly issued 50,000 Units. Immediately following the Closing, (i) OXB owned 180,000 Units, representing 80 percent (80%) of the fully diluted equity interests in OXB Solutions, and (ii) Homology owned 45,000 Units, representing 20 percent (20%) of the fully diluted equity interests in OXB Solutions.
Pursuant to the Amended and Restated Limited Liability Company Agreement of OXB Solutions (the “OXB Solutions Operating Agreement”) which was executed in connection with the Closing, at any time following the three-year anniversary of the Closing, (i) OXB will have an option to cause Homology to sell and transfer to OXB, and (ii) Homology will have an option to cause OXB to purchase from Homology, in each case all of Homology’s equity ownership interest in OXB Solutions at a price equal to 5.5 times the revenue for the immediately preceding
12-month
period (together, the “Options”), subject to a maximum amount of $74.1 million.
Pursuant to the terms of the OXB Solutions Operating Agreement, Homology is entitled to designate one director to the board of directors of OXB Solutions, currently Albert Seymour, Homology’s Chief Executive Officer.
Pursuant to the OXB Solutions Transaction, the Company also assigned all of its right, title and interest in, to and under its facility lease to OXB Solutions. However, as the Company remained jointly and severally liable
 
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for the payment of rent under the facility lease, the Company had not been released from being the primary obligor under such lease as of September 30, 2023 and therefore the related
right-of-use
asset and lease liability were not derecognized and remained on the Company’s balance sheet. The Company determined that the expected disposal of the fixed assets did not qualify for reporting as a discontinued operation since it did not represent a strategic shift that has or will have a major effect on the Company’s operations and financial results. Subsequently, the Company was released from being the primary obligor under such lease effective as of October 1, 2023 (see Note 14).
Equity Method of Accounting
The Company has significant influence over, but does not control, OXB Solutions through its noncontrolling representation on OXB’s board of directors and the Company’s equity interest in OXB Solutions. In addition, the Company and OXB Solutions have intra-entity transactions through a series of agreements entered into in conjunction with the OXB Solutions Transaction, OXB Solutions granted certain licenses to the Company, and the Company has representation on the joint steering committee which oversees the activities governed by the Supply Agreement. Accordingly, the Company does not consolidate the financial statements of OXB Solutions and accounts for its investment using the equity method of accounting.
The Company recorded its equity method investment in OXB Solutions at fair value upon deconsolidation of OXB Solutions as of the Closing. The fair value of the equity method investment was determined based on the market approach. This approach estimated the fair value of OXB Solutions based on the implied value for the entity using the consideration paid, including the Options, for a controlling interest in OXB Solutions at the entity’s formation. As part of its fair value analysis, the Company determined that the Options are embedded in the common equity units because the Options are not legally detachable or separately exercisable. Accordingly, the equity method investment and the Options represent one unit of account and the fair value recorded reflects the value of the equity interest and the Options. The valuation included certain subjective assumptions including discounts for lack of control and marketability given the consideration paid for OXB Solutions was for a controlling interest in the entity and the Company owns a noncontrolling interest. As of March 10, 2022, the Closing, the fair value of the Company’s investment in OXB Solutions was $31.2 million and the Company recorded a gain of $131.2 million on the sale of its manufacturing business in other income in the Company’s condensed consolidated statements of operations. The gain was computed as follows:
 
(in thousands)
  
March 10, 2022
 
Cash received
   $ 130,000  
Plus: Fair value of equity method investment
     31,223  
Less: Carrying value of transferred assets
     (29,974 ) 
  
 
 
 
Gain on sale of business
   $ 131,249  
  
 
 
 
During the nine months ended September 30, 2023, the Company determined that the fair value of its investment in OXB Solutions was negatively impacted due to a change in OXB Solutions’ forecasted performance relative to expected performance when the Company initially invested in OXB Solutions. The Company determined that the decline in value was deemed to be other than temporary and recorded an impairment charge of $3.8 million to reduce its equity method investment to fair value. The impairment charge is included in the loss on equity method investment in the Company’s condensed consolidated statements of operations.
In addition, the Company records its share of income or losses from OXB Solutions on a quarterly basis. For the nine months ended September 30, 2023, the Company recorded $8.1 million representing its share of OXB Solution’s net loss for the period. As of September 30, 2023, the carrying value of the equity method investment was $14.0 million.
 
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6. PROPERTY AND EQUIPMENT, NET
Property and equipment, net consists of the following:
 
    
As of
 
    
September 30, 2023
    
December 31, 2022
 
    
(in thousands)
 
Laboratory equipment
   $ —        $ 6,025  
Computers and purchased software
     —          644  
Furniture and fixtures
     —          645  
  
 
 
    
 
 
 
Property and equipment, at cost
     —          7,314  
Less: accumulated depreciation and amortization
     —          (6,236 ) 
  
 
 
    
 
 
 
Property and equipment, net
   $ —        $ 1,078  
  
 
 
    
 
 
 
In August 2023, consistent with its decision to stop further development of its programs and explore, review and evaluate a range of potential strategic options available to the Company, the Company committed to a plan to sell its remaining property and equipment and therefore has classified the amount as assets held for sale on the consolidated balance sheet as of September 30, 2023. The assets held for sale were reported at the lower of the carrying amount or fair value with no depreciation expense taken after August 2023.
Depreciation expense for the three and nine months ended September 30, 2023 was approximately $0.1 million and $0.6 million, respectively, compared to $0.3 million and $1.0 million, respectively for the three and nine months ended September 30, 2022. The Company had approximately $0.4 million of disposals of property and equipment during the three and nine months ended September 30, 2023. The Company had no disposals of property and equipment during the three and nine months ended September 30, 2022.
7. ACCRUED EXPENSES AND OTHER LIABILITIES
Accrued expenses and other liabilities consist of the following:
 
    
As of
 
    
September 30, 2023
    
December 31, 2022
 
    
(in thousands)
 
Accrued research and development expenses
   $ 8,198      $ 9,447  
Accrued compensation and benefits
     6,660        5,953  
Accrued professional fees
     648        1,052  
Accrued other
     205        2,263  
  
 
 
    
 
 
 
Total accrued expenses and other liabilities
   $ 15,711      $ 18,715  
  
 
 
    
 
 
 
8. RESTRUCTURING AND OTHER CHARGES
On July 25, 2023, the Company’s Board of Directors approved a process to explore, review and evaluate a range of potential strategic options available to the Company, including, without limitation, an acquisition, merger, reverse merger, sale of assets, strategic partnerships or other transactions. Therefore, based on cost-reduction initiatives intended to reduce the Company’s ongoing operating expenses and maximize shareholder value as the Company plans to pursue strategic options, the Company’s Board of Directors also approved a reduction in the Company’s workforce by approximately 80 employees, or 86% of the Company’s workforce as of July 2023. In connection with this corporate restructuring, the Company recorded a restructuring charge for
 
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severance and related costs of $6.9 million in the Company’s condensed consolidated statements of operations during the three months ended September 30, 2023.
The Company’s restructuring liability, which was included in accrued compensation and benefits, consisted of the following:
 
(in thousands)
  
Employee-Related

Costs
 
Accrued restructuring balance at January 1, 2023
   $ —    
Expenses incurred
     6,895  
Payments
     (2,154 ) 
  
 
 
 
Accrued restructuring balance at September 30, 2023
   $ 4,741  
  
 
 
 
The Company had previously granted certain of the terminated employees restricted stock units (“RSUs”) that vest in annual installments based on continued service to the Company, as well as options to purchase shares of the Company’s common stock that typically vest over a period of four years. In connection with the reduction in workforce, the Company agreed to accelerate the vesting of a portion of the RSUs that were unvested as of the employees’ termination dates, and also modify the stock options for terminated employees such that subject to the satisfaction of severance conditions, the terminated employees’ vested options will remain outstanding and exercisable until the first anniversary of each employee’s termination date. These equity modifications, described in detail in Note 10, resulted in a net reduction to stock based compensation expense of $0.3 million reflected within restructuring and other charges in the Company’s condensed consolidated statements of operations during the three months ended September 30, 2023.
9. COMMITMENTS AND CONTINGENCIES
Operating Leases
—In December 2017, the Company entered into a noncancelable operating lease for approximately 67,000 square feet of research and development, manufacturing and general office space in Bedford, Massachusetts. Prior to a subsequent amendment described below, the lease was set to expire in February 2027 with an option for an additional five-year term. Rent became due under the lease in two phases; rent on the first 46,000 square feet started in September 2018 and rent on the remaining 21,000 square feet started in March 2019. The initial annual base rent was $39.50 per square foot and increases by
three
percent annually. The Company is obligated to pay, on a
pro-rata
basis, real estate taxes and operating costs related to the premises. The lease agreement allowed for a tenant improvement allowance not to exceed $10.9 million, which the Company received in full, to be applied to the total cost of tenant improvements to the leased premises. The unamortized balance of the tenant improvement allowance was included in deferred rent incentives and recorded as a reduction to operating
right-of-use
asset upon adoption of the new leasing standards.
In November 2021, the Company entered into an amendment of its December 2017 lease agreement (the “Lease Amendment”) for its corporate headquarters in Bedford, Massachusetts. The Lease Amendment increases the space under lease by approximately 23,011 square feet (the “Expansion Premises”) and extended the expiration date of the existing premises under the lease from February 2027 to June 2030. The payment term with respect to the Expansion Premises commenced on May 1, 2022 and continues for a period of ten years and five months. The term of the Expansion Premises and the existing premises are not coterminous. Annual base rent for the existing premise under the Lease Amendment is approximately $4.7 million beginning on March 1, 2027, and increases by
three
percent annually; annual base rent for the Expansion Premises is approximately $1.4 million per year and increases by three percent annually. The Lease Amendment allows for tenant improvement allowances not to exceed $6.3 million in the aggregate. The Lease Amendment was accounted for as a lease modification and the
right-of-use
asset and operating lease liability for the existing premises were remeasured at the modification date, which resulted in an increase of $10.9 million to both the
right-of-use
asset and operating
 
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lease liabilities. In February 2022, the Company revised its assumption for when it expects to utilize the tenant improvement allowances. This change in assumption was accounted for as a lease modification and the
right-of-use
asset and operating lease liability for the existing premises were remeasured at the modification date, which resulted in an increase of $0.2 million to both the
right-of-use
asset and operating lease liabilities.
In March 2022, in accordance with its transaction with OXB Solutions, the Company assigned all of its right, title and interest in, to and under its corporate headquarters lease to OXB Solutions and entered into a sublease agreement whereby OXB Solutions subleased certain premises in its facility to Homology. The Company was not released from being the primary obligor under such lease as of September 30, 2023 and therefore the related
right-of-use
asset and operating lease liability were not derecognized and remained on the Company’s balance sheet and the Company acted as sublessor to OXB Solutions for accounting purposes. See Note 5 for details. During the nine months ended September 30, 2023, the Company received $2.3 million in sublease payments from OXB Solutions, which is recorded as a reduction to lease cost. In October 2023, the Company was released from being primary obligor under the lease (see Note 14).
In September 2022, the Company concluded that 100% of the tenant improvement allowances would be utilized by OXB Solutions. This change in assumption was accounted for as a lease modification and the
right-of-use
asset and operating lease liability for the existing premises were remeasured at the modification date, which resulted in an increase of $6.1 million to both the
right-of-use
asset and operating lease liabilities.
The following table summarizes operating lease costs and variable lease costs, as well as sublease income:
 
    
Nine months ended September 30,
 
    
        2023        
    
        2022        
 
    
(in thousands)
 
Operating lease costs
   $ 3,263      $ 2,826  
Variable lease costs
     1,551        1,698  
Sublease income
     (2,312 )       (1,210 ) 
  
 
 
    
 
 
 
Net lease cost
   $ 2,502      $ 3,314  
  
 
 
    
 
 
 
The maturities of the Company’s operating lease liabilities and minimum lease payments as of September 30, 2023 were as follows:
 
For the Years Ending December 31,
  
Amount
(in thousands)
 
2023
     1,134  
2024
     4,578  
2025
     4,715  
2026
     4,857  
Thereafter
     26,265  
  
 
 
 
Total undiscounted lease payments
   $ 41,549  
Less: imputed interest
     (13,211 ) 
  
 
 
 
Present value of operating lease liabilities
   $ 28,338  
  
 
 
 
The following table summarizes the lease term and discount rate as of September 30, 2023:
 
    
September 30, 2023
 
Weighted-average remaining lease term (years)
  
Operating leases
     7.5  
Weighted-average discount rate
  
Operating leases
     10.6 % 
 
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The following table summarizes the supplemental cash flow information related to the Company’s operating lease:
 
    
Nine months ended September 30,
 
    
        2023        
    
        2022        
 
    
(in thousands)
 
Cash paid for amounts included in the measurement of lease liabilities
   $ 3,310      $ 2,226  
Increase in lease liabilities and
right-of-use
assets due to lease remeasurements
   $ —        $ 6,262  
Legal Proceedings
—On March 25, 2022, the Company and certain of its executives were named as defendants in a putative securities class action lawsuit filed in the United States District Court for the Central District of California;
Pizzuto v. Homology Medicines, Inc.
, No. 2:22–CV–01968 (C.D. Cal 2022). The complaint alleges that the Company failed to disclose certain information regarding efficacy and safety in connection with a Phase I/II
HMI-102
clinical trial, and seeks damages in an unspecified amount. The case is in its early stages. The Company believes the claims alleged lack merit and filed a motion to transfer venue (filed September 2, 2022) and a motion to dismiss (filed October 17, 2022). On April 18, 2023, the court granted the motion to transfer, finding that venue was not proper in the Central District of California and transferring the case to the District of Massachusetts. Following the transfer, the case number changed to
1:23-cv-10858-AK
(D. Mass.). On May 9, 2023, the Massachusetts court issued an order permitting the parties to submit updated briefs in connection with the motion to dismiss, which were submitted on June 8, 2023, July 13, 2023, and August 3, 2023. The motion to dismiss remains pending. As the outcome is not presently determinable, any loss is neither probable nor reasonably estimable.
10. STOCK INCENTIVE PLANS
2015 Stock Incentive Plan
In December 2015, the Company’s Board of Directors adopted the 2015 Stock Incentive Plan (the “2015 Plan”), which provided for the grant of incentive stock options, nonqualified stock options and restricted stock awards to the Company’s employees, officers, directors, advisors, and outside consultants. Stock options granted under the 2015 Plan generally vest over a four-year period and expire ten years from the date of grant. Certain options provide for accelerated vesting if there is a change in control, as defined in the 2015 Plan. At September 30, 2023, there were no additional shares available for future grant under the 2015 Plan.
2018 Incentive Award Plan
In March 2018, the Company’s Board of Directors adopted and the Company’s stockholders approved the Homology Medicines, Inc. 2018 Incentive Award Plan (the “2018 Plan” and, together with the 2015 Plan, the “Plans”), which became effective on the day prior to the first public trading date of the Company’s common stock. Upon effectiveness of the 2018 Plan, the Company ceased granting new awards under the 2015 Plan.
The 2018 Plan provides for the grant of incentive stock options, nonqualified stock options, restricted stock awards, restricted stock units, stock appreciation rights and other stock or cash-based awards to employees and consultants of the Company and certain affiliates and directors of the Company. The number of shares of common stock initially available for issuance under the 2018 Plan was 3,186,205 shares of common stock plus the number of shares subject to awards outstanding under the 2015 Plan that expire, terminate or are otherwise surrendered, cancelled, forfeited or repurchased by the Company on or after the effective date of the 2018 Plan. In addition, the number of shares of common stock available for issuance under the 2018 Plan is subject to an annual increase on the first day of each calendar year beginning on January 1, 2019, and ending on and including January 1, 2028, equal to the lesser of (i) 4% of the Company’s outstanding shares of common stock on the final
 
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day of the immediately preceding calendar year and (ii) such smaller number of shares of common stock as determined by the Company’s Board of Directors, provided that not more than 20,887,347 shares of common stock may be issued under the 2018 Plan upon the exercise of incentive stock options. Therefore, on January 1, 2023, an additional 2,299,356 shares were added to the 2018 Plan, representing 4% of total common shares outstanding at December 31, 2022. As of September 30, 2023, there were 1,978,793 shares available for future grant under the 2018 Plan.
2018 Employee Stock Purchase Plan
In March 2018, the Company’s Board of Directors adopted and the Company’s stockholders approved the Homology Medicines, Inc. 2018 Employee Stock Purchase Plan (the “2018 ESPP”). The 2018 ESPP allows employees to buy Company stock through
after-tax
payroll deductions at a discount from market value. The 2018 ESPP is intended to qualify as an “employee stock purchase plan” under Section 423 of the Internal Revenue Code. The number of shares of common stock initially available for issuance under the 2018 ESPP was 353,980 shares of common stock plus an annual increase on the first day of each calendar year, beginning on January 1, 2019, and ending on and including January 1, 2028 equal to the lesser of (i) 1% of the Company’s outstanding shares of common stock on the final day of the immediately preceding calendar year and (ii) such smaller number of shares of common stock as determined by the Company’s Board of Directors, provided that not more than 4,778,738 shares of common stock may be issued under the 2018 ESPP. Therefore, on January 1, 2023, an additional 574,839 shares were added to the 2018 ESPP, representing 1% of total common shares outstanding at December 31, 2022. As of September 30, 2023, there were 2,693,911 shares available for future issuance under the 2018 ESPP.
Under the 2018 ESPP, employees may purchase common stock through
after-tax
payroll deductions at a price equal to 85% of the lower of the fair market value on the first trading day of an offering period or the last trading day of an offering period. The 2018 ESPP generally provides for offering periods of six months in duration that end on the final trading day of each February and August. In accordance with the Internal Revenue Code, no employee will be permitted to accrue the right to purchase stock under the 2018 ESPP at a rate in excess of $25,000 worth of shares during any calendar year during which such a purchase right is outstanding (based on the fair market value per share of the Company’s common stock as of the first day of the offering period).
During the nine months ended September 30, 2023, 133,817 shares were issued under the 2018 ESPP for aggregate proceeds to the Company of approximately $0.2 million. During the nine months ended September 30, 2022, 226,453 shares were issued under the 2018 ESPP for aggregate proceeds to the Company of approximately $0.6 million. Pursuant to the 2018 ESPP, the Company recorded stock-based compensation of less than $0.1 million during the three and nine months ended September 30, 2023 and 2022, respectively.
Stock Options
The fair value of each option award is estimated on the date of grant using the Black-Scholes option pricing model, with the assumptions noted in the table below. Expected volatility for the Company’s common stock was determined based on an average of the historical volatility of a peer group of publicly traded companies that are similar to the Company. The expected term of options was calculated using the simplified method, which represents the average of the contractual term of the option and the weighted-average vesting period of the option. The Company uses the simplified method because it does not have sufficient historical option exercise data to provide a reasonable basis upon which to estimate expected term. The assumed dividend yield is based upon the Company’s expectation of not paying dividends in the foreseeable future. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for periods commensurate with the expected term of the award. The Company recognizes forfeitures as they occur.
 
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The assumptions used in the Black-Scholes option pricing model are as follows (note that there were no options granted during the three months ended September 30, 2023):
 
    
Three months ended
   
Nine months ended September 30,
 
    
September 30, 2022
   
        2023        
   
        2022        
 
Expected volatility
     70.1 %     
69.2%-69.7%
     
68.7%-70.1%
 
Weighted-average risk-free interest rate
    
3.20%-3.66%
     
3.45%-4.22%
     
1.46%-3.66%
 
Expected dividend yield
     —   %      —   %      —   % 
Expected term (in years)
     6.25       5.5-6.25       5.5-6.25  
Underlying common stock fair value
   $
1.82-$2.82
    $
0.92-$1.60
    $
1.78-$4.17
 
The following table summarizes the Company’s stock option activity for the nine months ended September 30, 2023:
 
    
Number of
Options
    
Weighted-
Average Exercise
Price per Share
    
Weighted-
Average
Remaining
Contractual
Term
(in Years)
    
Aggregate
Intrinsic Value
 
                         
(in thousands)
 
Outstanding at January 1, 2023
     9,865,734      $ 10.96        7.2      $ 493  
Granted
     3,188,150      $ 1.53        
Exercised
     (3,366 )     $ 0.47        
Cancelled/Forfeited
     (623,776 )     $ 11.11        
  
 
 
          
Outstanding at September 30, 2023
     12,426,742      $ 8.55        4.9      $ 488  
  
 
 
          
Vested and expected to vest at September 30, 2023
     12,426,742      $ 8.55        4.9      $ 488  
  
 
 
          
Exercisable at September 30, 2023
     7,566,304      $ 11.80        4.5      $ 421  
  
 
 
          
The total intrinsic value of options exercised during the nine months ended September 30, 2023 and 2022 was insignificant for each period. The weighted-average grant date fair value per share of options granted during the nine months ended September 30, 2023 and 2022 was $1.01 and $1.72, respectively.
Stock Awards Modifications - Corporate Restructuring
In connection with the Company’s corporate restructuring (see Note 8), the Company terminated approximately 80 employees and modified approximately 3.3 million existing stock options and approximately 0.4 million existing restricted stock units (“RSUs”) granted to these terminated employees in prior periods. The modification of the vested stock options to permit terminated employees up to one year following their termination date to exercise their options, rather than the
90-day
window for terminated employees, is accounted for as a modification under FASB ASC Topic 718,
Compensation—Stock Compensation
(“ASC 718”). Accordingly, the Company recognized incremental compensation cost on the modification date in an amount equal to the difference between the fair value of the awards before and after the modification. The fair value of the awards immediately before assumes an expected term equal to 90 days from the termination date, whereas the fair value immediately after assumes an expected term equal to one year from the termination date. Total incremental compensation cost recognized in the three months ended September 30, 2023 related to awards that were vested as of the modification date was less than $0.1 million. All unvested stock options were forfeited upon termination and the Company reversed all compensation cost previously recorded on the forfeited awards. Total compensation cost reversed in the three months ended September 30, 2023 was less than $0.1 million.
 
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The terminated employees’ RSUs were modified to accelerate the vesting of a portion of the RSUs that were unvested as of the employees’ termination dates. The accelerated vesting of certain RSUs is accounted for as a Type III (improbable to probable) modification under ASC 718. Accordingly, the Company reversed all compensation cost previously recorded on the awards that are not expected to vest under the original terms. Total compensation cost reversed in the three months ended September 30, 2023 was approximately $0.2 million. Total compensation cost of less than $0.1 million, equal to the modification date fair value, was recognized over the remaining service period, beginning on the modification date and ending on each employee’s termination date.
Stock Awards Modifications - OXB Solutions Transaction
As part of the transaction with OXB Solutions (see Note 5), the Company transferred employees to OXB Solutions and modified approximately 1.6 million existing stock options and approximately 0.1 million existing restricted stock units granted to these transferred employees in prior periods in order to permit such individuals to continue vesting in their awards and exercise their vested options as long as they are employed by and provide services to OXB Solutions. The modification of the unvested stock awards to continue vesting was accounted for as a Type III (improbable to probable) modification under ASC 718. Accordingly, the Company reversed all compensation cost previously recorded on the awards that were not expected to vest under the original terms. Total compensation cost reversed in the three months ended March 31, 2022 was less than $0.1 million. Total compensation cost of $0.8 million, equal to the modification date fair value, will be recognized over the remaining service period. A portion of this total compensation cost will be included as a component of the loss from equity method investment.
The modification of the vested stock awards to permit transferred employees to exercise their options over the remaining life of the award, rather than the
90-day
window for terminated employees, was accounted for as a modification under ASC 718. Accordingly, the Company recognized incremental compensation cost on the modification date in an amount equal to the difference between the fair value of the awards before and after modification. The fair value of the awards immediately before modification assumed a
90-day
expected term, whereas the fair value immediately after assumed an expected term equal to the remaining life of the modified options. Total incremental compensation cost recognized in the year ended December 31, 2022 related to awards that were vested as of the modification date was $0.4 million.
Restricted Stock Units
The fair value of RSUs is based on the fair market value of the Company’s common stock on the date of grant. Each RSU represents a contingent right to receive one share of the Company’s common stock upon vesting. In general, RSUs vest annually in two or three equal installments on January 1st of each year after the grant date. The following table summarizes the Company’s RSU activity for the nine months ended September 30, 2023:
 
    
Number of
Restricted
Stock
Units
    
Weighted-
Average Grant
Date Fair Value
 
Outstanding at January 1, 2023
     543,179      $ 6.12  
Granted
     483,850      $ 1.60  
Vested
     (281,117 )     $ 5.31  
Forfeited
     (258,184 )     $ 2.54  
  
 
 
    
Outstanding at September 30, 2023
     487,728      $ 3.04  
  
 
 
    
 
F-5
5

Stock-based Compensation Expense
The Company recognizes compensation expense for awards to employees based on the grant date fair value of stock-based awards on a straight-line basis over the period during which an award holder provides service in exchange for the award, which is generally the vesting period. The Company recorded stock-based compensation expense related to stock options, shares purchased under the 2018 ESPP, restricted stock units and stock award modifications as follows:
 
    
Three months ended
September 30,
    
Nine months ended
September 30,
 
    
2023
    
2022
    
2023
    
2022
 
    
(in thousands)
 
Research and development
   $ 230      $ 889      $ 1,507      $ 4,143  
General and administrative
     1,477        1,882        4,970        5,822  
  
 
 
    
 
 
    
 
 
    
 
 
 
     $1,707      $2,771      $6,477      $9,965  
  
 
 
    
 
 
    
 
 
    
 
 
 
As of September 30, 2023, there was $10.5 million of unrecognized compensation expense related to unvested employee and
non-employee
share-based compensation arrangements granted under the Plans. The unrecognized compensation expense is estimated to be recognized over a period of 2.2
years at September 30, 2023.
11. NET INCOME (LOSS) PER SHARE
Basic net income (loss) per share is computed by dividing net income (loss) by the weighted-average number of common shares outstanding during the applicable period. Diluted net income (loss) per share incorporates the additional shares issuable upon assumed exercise of stock options and the vesting of restricted stock units, except in such case when their inclusion would be anti-dilutive.
 
    
Three months ended
September 30,
    
Nine months ended
September 30,
 
(in thousands, except per share amounts)
  
2023
    
2022
    
2023
    
2022
 
Numerator:
           
Net income (loss)
   $ (32,954 )     $ (33,726 )     $ (96,842 )     $ 29,290  
Denominator:
           
Weighted-average common shares outstanding-basic
     57,853,132        57,447,192        57,788,755        57,372,399  
Dilutive securities
     —        —        —        528,899  
  
 
 
    
 
 
    
 
 
    
 
 
 
Weighted-average common shares outstanding-diluted
     57,853,132        57,447,192        57,788,755        57,901,298  
Net income (loss) per share-basic
   $ (0.57 )     $ (0.59 )     $ (1.68 )     $ 0.51  
  
 
 
    
 
 
    
 
 
    
 
 
 
Net income (loss) per share-diluted
   $ (0.57 )     $ (0.59 )     $ (1.68 )     $ 0.51  
  
 
 
    
 
 
    
 
 
    
 
 
 
For the three and nine months ended September 30, 2023, as well as for the three months end September 30, 2022, the effect of dilutive securities including stock options, restricted stock units and unvested common stock from early exercise of options, was excluded from the denominator for the calculation of diluted net loss per share because the Company recognized a net loss for the periods and their inclusion would be anti-dilutive. Anti-dilutive securities excluded for the three months ended September 30, 2023 and 2022 were 12,993,266 and 9,933,508, respectively, and for the nine months ended September 30, 2023 and 2022 were 12,507,026 and 9,048,927, respectively.
 
F-5
6

12. PFIZER STOCK PURCHASE AGREEMENT
On November 9, 2020, the Company entered into a common stock purchase agreement (the “Stock Purchase Agreement”) with Pfizer Inc. (“Pfizer”), pursuant to which the Company agreed to issue and sell to Pfizer 5,000,000 shares of the Company’s common stock through a private placement transaction (the “Private Placement”) at a purchase price of $12.00 per share, for an aggregate purchase price of $60.0 million. The shares of common stock sold to Pfizer were subject to a
one-year
lock-up
from closing, during which time Pfizer was prohibited from selling or otherwise disposing of such shares.
Under the Stock Purchase Agreement, Pfizer was granted an exclusive right of first refusal (the “ROFR”) for a
30-month
period (the “ROFR Period”) beginning on the date of the closing of the Private Placement (collectively, the “ROFR Provision”), to negotiate a potential collaboration on the development and commercialization of
HMI-102
and
HMI-103.
The ROFR Period expired on May 9, 2023. In addition to the ROFR, the Stock Purchase Agreement provided for an information sharing committee (the “Information Committee”), comprised of representatives of each company, which served as a forum for sharing information regarding the development of
HMI-102
and
HMI-103
during the ROFR Period.
The Company recorded the issuance of common stock at its estimated fair value of $52.0 million, which reflected a discount for the lack of marketability of the shares. The remaining $8.0 million of aggregate purchase price was allocated to the other elements of the Stock Purchase Agreement, which represented a contract with a customer. The Company concluded that the Information Committee represented the only performance obligation under the contract. The ROFR did not provide Pfizer with a material right and was therefore not a performance obligation. As such, the Company allocated the $8.0 million to the Information Committee obligation.
The Company recognizes revenue over time as the measure of progress, which it believes best depicts the transfer of control to Pfizer. The Information Committee met regularly over the ROFR Period to share information which resulted in recognition of the transaction price over the
30-month
ROFR Period.
During the nine months ended September 30, 2023, the Company recognized collaboration revenue of $1.2 million, compared to $0.8 million and $2.4 million, respectively for the three and nine months ended September 30, 2022. As the ROFR Period expired in May 2023, there was
no
revenue recognized during the three months ended September 30, 2023. There was no deferred revenue related to the Company’s obligation to Pfizer as of September 30, 2023. As of December 31, 2022, there was approximately $1.2 million of deferred revenue related to the Company’s obligation to Pfizer.
13. RELATED PARTY TRANSACTIONS
Oxford Biomedica Solutions LLC
As described in Note 5, the Company has significant influence over, but does not control, OXB Solutions through its noncontrolling representation on OXB Solution’s board of directors and the Company’s equity interest in OXB Solutions. In March 2022, concurrently with the closing of the transaction with OXB Solutions, the Company entered into certain ancillary agreements with OXB Solutions including a supply agreement, a lease assignment and assumption agreement, a sublease agreement and a transitional services agreement.
Supply Agreement
Pursuant to the terms of the Manufacturing and Supply Agreement with OXB Solutions entered into in March 2022 (the “Supply Agreement”), the Company agreed to purchase from OXB Solutions at least 50% of its clinical supply requirements of
AAV-based
products during the initial term of the supply agreement. The Supply Agreement provides for an initial term of three years, which may be extended for an additional
one-year
term. Under the Supply Agreement, the Company is committed to purchase a minimum number of batches of drug substance and drug product, as well as process development services, totaling approximately $29.7 million by the
 
F-5
7

fiscal year ending December 31, 2023. As of September 30, 2023, the Company had approximately $1.4 million in remaining purchase obligations to OXB Solutions pursuant to the Supply Agreement. There are no minimum purchase commitments in 2024 (year three) of the Supply Agreement. After the initial term, the Company will have the right to terminate the Supply Agreement for convenience or other reasons specified in the Supply Agreement upon prior written notice. Either party may terminate the Supply Agreement upon an uncured material breach by the other party or upon the bankruptcy or insolvency of the other party.
During the three and nine months ended September 30, 2023, the Company recorded purchases of drug substance from OXB Solutions related to the Supply Agreement of $8.4 million and $21.7 million, respectively, as well as purchases of process development services of approximately $3.1 million and $5.8 million, respectively, and stability services and other support services of approximately $0.4 million and $1.2 million, respectively. During the three and nine months ended September 30, 2022, the Company recorded purchases of drug substance from OXB Solutions related to the Supply Agreement of $6.0 million and $7.5 million, respectively, as well as purchases of process development services of approximately $2.2 million and $10.2 million, respectively. These amounts are included within research and development expenses on the Company’s condensed consolidated statements of operations. The amounts due to OXB Solutions under the Supply Agreement were $12.6 million and $5.2 million as of September 30, 2023 and December 31, 2022, respectively, and were included in accounts payable and accrued expenses and other liabilities on the Company’s condensed consolidated balance sheets.
Lease Assignment and Sublease Agreement
As described in Note 9, the Company leases space for research and development, manufacturing and general office space in Bedford, Massachusetts. In March 2022, the Company and OXB Solutions entered into a lease assignment and assumption agreement pursuant to which Homology assigned all of its right, title and interest in, to and under this lease to OXB Solutions and a sublease agreement whereby OXB Solutions subleased certain premises in its facility to Homology. However, as of and for the three and nine months ended September 30, 2023, the Company remained jointly and severally liable for the payment of rent under this lease and had not been released from being the primary obligor under such lease and therefore the related
right-of-use
asset and operating lease liability were not derecognized and remained on the Company’s condensed consolidated balance sheets. Therefore, the Company is recording sublease income from OXB Solutions as if it were subleasing the space to OXB Solutions. On October 1, 2023, the Company was released from being the primary obligor under the lease (see Note 14).
During the three and nine months ended September 30, 2023, the Company recorded sublease income of $0.8 million and $2.3 million, respectively, related to the sublease agreement with OXB Solutions. During the three and nine months ended September 30, 2022, the Company recorded sublease income of $0.5 million and $1.2 million, respectively, related to the sublease agreement with OXB Solutions. This amount was recognized as a reduction to lease expense in the Company’s condensed consolidated statements of operations.
During 2023, OXB Solutions assumed responsibility for paying the landlord for invoices related to the leased property and, as such, the Company began making direct payments to OXB Solutions for amounts due to OXB Solutions under the sublease. Therefore, as of September 30, 2023, the amount of sublease income payable to OXB Solutions was $0.1 million and was included in accrued expenses on the Company’s condensed consolidated balance sheets. As of December 31, 2022, the amount of sublease income receivable from OXB Solutions was $0.5 million and was included in prepaid expenses and other current assets on the Company’s condensed consolidated balance sheets.
 
F-5
8

Transitional Services Agreement
Under the transitional services agreement with OXB Solutions (the “Services Agreement”), the Company is performing certain services for the benefit of OXB Solutions and OXB Solutions is performing certain services for the benefit of the Company. The term of the Services Agreement will not exceed eighteen months and lasts until the earlier of termination for convenience, termination for cause in the event of an uncured material breach, termination as a result of bankruptcy of either party, and expiration or termination of the only remaining outstanding service as set forth in the Services Agreement. Each company is fully reimbursing the other for these services. The Services Agreement was substantially complete as of September 30, 2023.
Expenses incurred by the Company for services provided by OXB Solutions recognized under the Services Agreement totaled $0.3 million for the nine months ended September 30, 2023, and $0.2 million and $0.5 million for the three and nine months ended September 30, 2022, respectively, and are presented within research and development expenses in the condensed consolidated statements of operations as the services related to facilities support within the Company’s research and development labs. As of September 30, 2023 and December 31, 2022, the amount due to OXB Solutions under the Services Agreement was $0.1 million at each balance sheet date, and was included in accrued expenses and other liabilities on the Company’s condensed consolidated balance sheets.
The Company provided finance, human resources, IT and legal services to OXB Solutions under the Services Agreement and recognized $0.5 million for the nine months ended September 30, 2023, and $0.8 million and $1.7 million for the three and nine months ended September 30, 2022, respectively, for amounts reimbursed by OXB Solutions as a reduction to general and administrative expense in the Company’s condensed consolidated statements of operations. The Company did not provide reimbursable services to OXB Solutions under the Services Agreement during the three months ended September 30, 2023. As of December 31, 2022, the Company had a receivable balance of $0.3 million from OXB Solutions which was recorded as a component of prepaid expenses and other current assets in the Company’s condensed consolidated balance sheets. Pursuant to the Services Agreement, the Company has been paying vendors on OXB Solutions’ behalf; this process will be fully transitioned to OXB Solutions in 2023. As of December 31, 2022, the amount receivable from OXB Solutions for amounts paid to vendors on their behalf was $1.1 million and was included in prepaid expenses and other current assets on the Company’s condensed consolidated balance sheets.
14. SUBSEQUENT EVENTS
Release Letter
On September 25, 2023, the Company signed and executed a release letter with its lessor related to its headquarters in Bedford, MA. The lessor agreed to release the Company of all obligations under the lease effective October 1, 2023 (the “Release Date”) in exchange for a $0.1 million cash payment. For accounting purposes, the release letter is not considered a modification of the lease until the Release Date as the Company is not released from its obligations under the lease until such date. As of September 30, 2023, the lease had a remaining
right-of-use
asset balance of $19.5 million and an operating lease liability balance of $28.3 million. On October 1, 2023, the Company will write off the
right-of-use
asset and operating lease liability and record the difference as a gain of $8.8 million within other income on the condensed consolidated statements of operations. Because the Company’s sublease agreement with OXB Solutions remains in effect after termination of the head lease, the Company will recognize a new
right-of-use
asset and an operating lease liability of $1.6 million, which equals the present value of the future sublease payments owed to OXB Solutions for the remaining term of the sublease. The Company is actively searching for a subtenant to take over its sublease with OXB Solutions and is evaluating whether there is any impairment of the related
right-of-use
asset.
 
F-59

Agreement and Plan of Merger
On November 16, 2023, the Company, Kenobi Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of the Company (“Merger Sub”), and Q32 Bio Inc., a Delaware corporation (“Q32”), entered into an Agreement and
Plan
of Merger (the “Merger Agreement”), pursuant to which, among other matters, and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, Merger Sub will merge with and into Q32, with Q32 continuing as a wholly owned subsidiary of the Company and the surviving corporation of the merger (the “Merger”).
The Merger Agreement contains customary representations, warranties and covenants made by the Company and Q32, including covenants relating to obtaining the requisite approvals of the stockholders of the Company and Q32, indemnification of directors and officers, and the Company’s and Q32’s conduct of their respective businesses between the date of signing the Merger Agreement and the closing of the Merger. The Merger Agreement also contains certain customary termination rights. The Merger Agreement further provides that, upon termination of the Merger Agreement under specified circumstances, Q32 may be required to pay the Company a termination fee of $5.9 million, or the Company may be required to pay Q32 a termination fee of $2.4 million.
 
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Table of Contents
Report of Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors of Q32 Bio Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Q32 Bio Inc. (the Company) as of December 31, 2022 and 2021, the related consolidated statements of operations and comprehensive loss, convertible preferred stock and stockholders’ deficit and cash flows for the years then ended, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2022 and 2021, and the results of its operations and its cash flows for the years then ended in conformity with U.S. generally accepted accounting principles.
The Company’s Ability to Continue as a Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has suffered recurring losses from operations, has a working capital deficiency, and has stated that substantial doubt exists about the Company’s ability to continue as a going concern. Management’s evaluation of the events and conditions and management’s plans regarding these matters are also described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB and in accordance with auditing standards generally accepted in the United States of America. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
We have served as the Company’s auditor since 2020.
/s/ Ernst & Young LLP
Boston, Massachusetts
December 15, 2023
 
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Table of Contents
Q32 BIO INC.
CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except share and per share data)
 
    
December 31,
 
    
2022
   
2021
 
Assets
    
Current assets:
    
Cash and cash equivalents
  
$
43,893
 
  $ 32,247  
Prepaid expenses and other current assets
  
 
2,960
 
    1,751  
  
 
 
   
 
 
 
Total current assets
  
 
46,853
 
    33,998  
Property and equipment, net
  
 
2,276
 
    203  
Right-of-use
asset, operating leases
  
 
6,890
 
    —    
Restricted cash and restricted cash equivalents
  
 
5,647
 
    647  
Other noncurrent assets
  
 
108
 
    303  
  
 
 
   
 
 
 
Total assets
  
$
61,774
 
  $ 35,151  
  
 
 
   
 
 
 
Liabilities, convertible preferred stock and stockholders’ deficit
    
Current liabilities:
    
Accounts payable
  
$
1,435
 
  $ 2,676  
Accrued expenses and other current liabilities
  
 
9,497
 
    4,540  
Convertible notes
  
 
32,402
 
    —    
Deferred revenue, current portion
  
 
14,531
 
    —    
  
 
 
   
 
 
 
Total current liabilities
  
 
57,865
 
    7,216  
Other noncurrent liabilities
  
 
—  
 
    728  
Deferred revenue, net of current portion
  
 
11,318
 
    —    
Lease liability, net of current portion
  
 
6,786
 
    —    
Venture debt
  
 
5,072
 
    4,972  
  
 
 
   
 
 
 
Total liabilities
  
 
81,041
 
    12,916  
Commitments and contingencies (Note 7)
    
Series A convertible preferred stock, $0.0001 par value, 47,628,788 shares authorized, issued and outstanding as of December 31, 2022 and 2021 (liquidation preference of $47,629 at December 31, 2022)
  
 
47,458
 
    47,458  
Series
A-1
convertible preferred stock, $0.0001 par value, 6,500,000 shares authorized, issued and outstanding at December 31, 2022 and 2021 (liquidation preference of $5,753 as of December 31, 2022)
  
 
4,132
 
    4,132  
Series B convertible preferred stock, $0.0001 par value, 54,689,627 shares authorized, issued and outstanding at December 31, 2022 and 2021 (liquidation preference of $60,000 as of December 31, 2022)
  
 
59,855
 
    59,855  
  
 
 
   
 
 
 
Total convertible preferred stock
  
 
111,445
 
    111,445  
Stockholders’ deficit:
    
Common stock, $0.0001 par value; 141,900,000 and 130,000,000 shares authorized, 7,139,216 and 6,831,357 shares issued and outstanding at December 31, 2022 and 2021, respectively
  
 
1
 
    1  
Additional
paid-in
capital
  
 
2,625
 
    1,318  
Accumulated deficit
  
 
(133,338
) 
    (90,529 ) 
  
 
 
   
 
 
 
Total stockholders’ deficit
  
 
(130,712
) 
    (89,210 ) 
  
 
 
   
 
 
 
Total liabilities, convertible preferred stock and stockholders’ deficit
  
$
61,774
 
  $ 35,151  
  
 
 
   
 
 
 
The accompanying notes are an integral part of these consolidated financial statements.
 
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Table of Contents
Q32 BIO INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(amounts in thousands, except share and per share data)
 
    
Year Ended December 31,
 
    
2022
   
2021
 
Collaboration arrangement revenue
  
$
6,651
 
  $ —    
Operating expenses:
    
Research and development
  
 
35,814
 
    29,929  
General and administrative
  
 
10,062
 
    6,764  
  
 
 
   
 
 
 
Total operating expenses
  
 
45,876
 
    36,693  
  
 
 
   
 
 
 
Loss from operations
  
 
(39,225
) 
    (36,693 ) 
Change in fair value of convertible notes
  
 
(2,402
) 
    —    
Other income (expense), net
  
 
(1,120
) 
    (324 ) 
  
 
 
   
 
 
 
Total other income (expense), net
  
 
(3,522
) 
    (324 ) 
  
 
 
   
 
 
 
Loss before provision for income taxes
  
 
(42,747
) 
    (37,017 ) 
Provision for income taxes
  
 
(62
) 
    (547 ) 
Net loss and comprehensive loss
  
$
(42,809
) 
  $ (37,564 ) 
  
 
 
   
 
 
 
Weighted-average common shares—basic and diluted
  
 
7,025,420
 
    6,470,930  
  
 
 
   
 
 
 
Net loss per share attributable to common stockholders—basic and diluted
  
$
(6.09
) 
  $ (5.81 ) 
  
 
 
   
 
 
 
The accompanying notes are an integral part of these consolidated financial statements.
 
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Table of Contents
Q32 BIO INC.
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT
(amounts in thousands, except share data)
 
   
Series A
Convertible
Preferred Stock
   
Series
A-1

Convertible
Preferred Stock
   
Series B
Convertible
Preferred Stock
   
Common Stock
   
Additional
Paid in

Capital
   
Accumulated

Deficit
   
Total
Stockholders’

Deficit
 
   
Shares
   
Amount
   
Shares
   
Amount
   
Shares
   
Amount
   
Shares
   
Amount
 
Balance as of December 31, 2020
    47,628,788     $ 47,458       6,500,000     $ 4,132       36,459,754     $ 39,865       6,222,829     $ 1     $ 450     $ (52,965 )    $ (52,514 ) 
Issuance of series B convertible preferred stock, net of issuance costs of $0.01 million
    —         —         —         —         18,229,873       19,990       —         —         —         —         —    
Exercise of stock options
    —         —         —         —         —         —         417,479       —         115       —         115  
Vesting of restricted stock
    —         —         —         —         —         —         187,817       —         —         —         —    
Stock-based compensation expense
    —         —         —         —         —         —         —         —         753       —         753  
Net loss
    —         —         —         —         —         —         —         —         —         (37,564 )      (37,654 ) 
 
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Balance as of December 31, 2021
    47,628,788       47,458       6,500,000       4,132       54,689,627       59,855       6,828,125       1       1,318       (90,529 )      (89,210 ) 
Exercise of stock options
    —         —         —         —         —         —      
 
307,859
 
    —      
 
69
 
    —      
 
69
 
Vesting of restricted stock
    —         —         —         —         —         —      
 
3,232
 
    —         —         —         —    
Stock-based compensation expense
    —         —         —         —         —         —         —         —      
 
1,238
 
    —      
 
1,238
 
Net loss
    —         —         —         —         —         —         —         —         —      
 
(42,809
)
 
 
 
(42,809
)
 
 
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Balance as of December 31, 2022
 
 
47,628,788
 
 
$
47,458
 
 
 
6,500,000
 
 
$
4,132
 
 
 
54,689,627
 
 
$
59,855
 
 
 
7,139,216
 
 
$
1
 
 
$
2,625
 
 
$
(133,338
) 
 
$
(130,712
) 
 
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
The accompanying notes are an integral part of these consolidated financial statements.
 
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Table of Contents
Q32 BIO INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(amounts in thousands)
 
    
Year Ended
December 31,
 
    
2022
   
2021
 
Cash flows from operating activities:
    
Net loss
  
$
(42,809
) 
  $ (37,564 ) 
Adjustments to reconcile net loss to net cash used in operating activities:
    
Amortization of debt discount and issuance costs
  
 
100
 
    102  
Depreciation expense
  
 
370
 
    47  
Loss on disposal of property and equipment
  
 
23
 
    —    
Stock-based compensation expense
  
 
1,238
 
    753  
Non-cash
lease expense
  
 
776
 
    —    
Change in fair value of convertible notes
  
 
2,402
 
    —    
Changes in operating assets and liabilities:
    
Prepaid expenses and other current assets
  
 
(1,209
) 
    (96 ) 
Other noncurrent assets
  
 
195
 
    (244 ) 
Accounts payable
  
 
(1,241
) 
    1,099  
Operating lease liability
  
 
(409
) 
    —    
Accrued expenses and other current liabilities
  
 
3,758
 
    2,924  
Deferred revenue
  
 
25,849
 
    —    
  
 
 
   
 
 
 
Net cash used in operating activities
  
 
(10,957
) 
    (32,979 ) 
Cash flows from investing activities:
    
Purchases of property and equipment
  
 
(2,485
) 
    (157 ) 
Proceeds from sale of property and equipment
  
 
19
 
    —    
  
 
 
   
 
 
 
Net cash used in investing activities
  
 
(2,466
) 
    (157 ) 
Cash flows from financing activities:
    
Proceeds from issuance of preferred stock, net of issuance costs
  
 
—  
 
    19,990  
Proceeds from exercise of common stock options
  
 
69
 
    115  
Proceeds from issuance of convertible debt
  
 
30,000
 
    —    
  
 
 
   
 
 
 
Net cash provided by financing activities
  
 
30,069
 
    20,105  
Net increase (decrease) in cash, cash equivalents, restricted cash and restricted cash equivalents
  
 
16,646
 
    (13,031 ) 
Cash, cash equivalents, restricted cash and restricted cash equivalents at beginning of period
  
 
32,894
 
    45,925  
  
 
 
   
 
 
 
Cash, cash equivalents, restricted cash and restricted cash equivalents at end of period
  
$
49,540
 
  $ 32,984  
  
 
 
   
 
 
 
Supplemental disclosure of
non-cash
operating, investing and financing activities:
    
Property and equipment additions included in accounts payable and accrued expenses
  
$
—  
 
  $ 20  
Right-of-use
asset obtained in exchange for new operating lease liability
  
$
7,666
 
  $ —    
The accompanying notes are an integral part of these consolidated financial statements.
 
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Q32 BIO INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. Nature of the Business
Q32 Bio Inc. (the Company) was formed on April 10, 2017 as Admirx, Inc. under the laws of the state of Delaware and is headquartered in Waltham, Massachusetts. On March 20, 2020, the Company changed its name to Q32 Bio Inc. The Company aims to bring safer, more efficacious therapeutics to patients suffering from a wide range of devastating autoimmune and inflammatory diseases, starting with those rooted in the complement system and
interleukin-7
(IL-7)
signaling pathways.
Since its inception, the Company’s operations have been focused on organizing and staffing, business planning, raising capital, establishing the Company’s intellectual property portfolio and performing research and development of its product candidates, programs and platform. The Company has primarily funded its operations with proceeds from the sale of convertible preferred stock, convertible notes, venture debt and its collaboration arrangement.
Risks and Uncertainties
The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including but not limited to, risks associated with completing preclinical studies and clinical trials, obtaining regulatory approvals for product candidates, development by competitors of new biopharmaceutical products, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Programs currently under development will require significant additional research and development efforts, including preclinical and clinical testing, and will need to obtain regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from product sales.
Liquidity and Going Concern
As of December 31, 2022, the Company had cash and cash equivalents of $43.9 million and an accumulated deficit of $133.3 million. The Company had a net working capital deficiency of $11.0 million for the year ended December 31, 2022, and a net loss of $42.8 million and $37.6 million for the years ended December 31, 2022 and 2021, respectively. The Company has funded its net losses principally through the sale of preferred stock, convertible notes, debt, and proceeds from a collaboration arrangement. The Company expects to experience negative cash flows from operations and net losses for the foreseeable future as it continues to invest significantly in research and development of its product candidates and platform.
All of the Company’s products candidates are in development. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products candidates developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapid change in technology and substantial competition. In addition, the Company is dependent upon the services of its employees and consultants.
The Company expects its existing cash and cash equivalents will not be sufficient to allow the Company to fund its operating expenses and capital expenditures requirements through at least the next twelve months from the issuance of these consolidated financial statements.
 
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As a result, the Company will need substantial additional funding to support its continued operations and growth strategy. Until such a time as the Company can generate significant revenue from product sales, if ever, the Company expects to finance its operations through the sale of equity, debt financings or other capital sources, including collaborations with other companies or other strategic transactions. The Company may be unable to raise additional funds or enter into such other agreements on terms acceptable to the Company, or at all. If the Company fails to raise capital or enter into such agreements, the Company may have to significantly delay, scale back or discontinue the development and commercialization of one or more of its product candidates or delay its pursuit of potential
in-licenses
or acquisitions. The Company is seeking to complete a transaction with Homology Medicines, Inc. (Homology) as well as complete a concurrent private placement to raise additional capital. However, there can be no assurances that such transactions will be completed.
Based on its recurring losses from operations incurred since inception, the expectation of continuing operating losses for the foreseeable future, and the need to raise additional capital to finance its future operations, the Company has concluded that there is substantial doubt about its ability to continue as a going concern within one year after the date that these consolidated financial statements are issued.
The accompanying consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties described above. Accordingly, the consolidated financial statements have been prepared on a basis that assumes the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.
2. Summary of Significant Accounting Policies
Basis of Presentation
The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (GAAP). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Update (ASU) of the Financial Accounting Standards Board (FASB).
Principles of Consolidation
The accompanying consolidated financial statements include those of the Company and its
wholly-owned
subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. Actual results could materially differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these consolidated financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the valuation of common stock awards, the valuation of convertible notes, the accruals of research and development expenses, the identification of material rights and estimation of standalone selling price for the identified performance obligations in the collaboration agreement and the inputs and assumptions to the over-time recognition of revenue under the collaboration agreement. Estimates are periodically reviewed considering changes in circumstances, facts and historical experience. Actual results may differ from the Company’s estimates.
 
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Segment Information
Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions on how to allocate resources and assess performance. The Company’s chief operating decision maker is the chief executive officer (CEO). The Company and the CEO view the Company’s operations and manage its business as one operating segment. All material long-lived assets of the Company reside in the United States.
Foreign Currency Transactions
The Company’s functional currency is the United States dollar. Foreign currency transaction gains and losses are recorded in the statement of operations and comprehensive loss.
Concentrations of Credit Risk and Significant Suppliers
Financial instruments that potentially expose the Company to credit risk primarily consist of cash, cash equivalents, restricted cash and restricted cash equivalents. The Company maintains its cash, cash equivalents, restricted cash and restricted cash equivalents balances with accredited financial institutions and, consequently, the Company does not believe it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships.
The Company’s cash management limits investment to investment-grade securities with the objective to preserve capital and to maintain liquidity until the funds can be used in business operations. The Company maintains its cash in bank deposit accounts that are Federal Deposit Insurance Corporation (FDIC) insured up to $250,000. At times, the Company’s bank accounts may exceed the federal insurance limit.
The Company is dependent on contract development and manufacturing organizations (CDMOs) to supply products for research and development activities in its programs. In particular, the Company relies and expects to continue to rely on a small number of manufacturers to supply it with its requirements for the active pharmaceutical ingredients, other raw materials and formulated drugs related to these programs. These programs could be adversely affected by a significant interruption in the supply of active pharmaceutical ingredients, other raw materials and formulated drugs. The Company is also dependent on contract research organization (CROs) which provide services related to the research and development activities in its programs.
Off-Balance
Sheet Risk
As of December 31, 2022 and 2021, the Company had no
off-balance-sheet
risk such as foreign exchange contracts, option contracts or other foreign hedging arrangements.
Fair Value Measurements
Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:
Level
 1 –
Quoted prices in active markets for identical assets or liabilities.
Level
 2 –
Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
 
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Level
 3 –
Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
Property and Equipment
Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the respective assets. Major additions and betterments are capitalized; maintenance and repairs, which do not improve or extend the life of the respective assets, are charged to operations as incurred. Upon retirement or sale, the cost and related accumulated depreciation of assets disposed of are removed from the accounts and any resulting gain or loss is included in loss from operations.
 
    
Estimated Useful Life (Years)
Lab equipment
   5
Furniture and fixtures
   3
Computer equipment
   3
Leasehold improvements
   Shorter of useful life or term
of associated lease
Leases
The Company adopted FASB ASU
No. 2016-02,
Leases (ASC 842)
, effective January 1, 2021 using the modified retrospective approach and utilizing the effective date as its date of initial application.
The Company evaluates whether an arrangement is or contains a lease at contract inception. If a contract is or contains a lease, lease classification is determined at lease commencement, which represents the date at which the underlying asset is made available for use by the Company. The Company’s lease terms are generally measured at the respective lease’s noncancelable term and exclude any optional extension terms as the Company is not reasonably certain to exercise such options. The Company elected the short-term lease exemption and therefore does not recognize lease liabilities and right of use assets for lease arrangements with the original lease terms of twelve months or less.
Lease liabilities represent the Company’s obligation to make lease payments under a lease arrangement. Lease liabilities are measured as the present value of fixed lease payments, discounted using an incremental borrowing rate, as interest rates implicit in the Company’s lease arrangements are generally not readily determinable. The Company elected the practical expedient to not separate lease and
non-lease
components for its real estate leases and therefore both are considered when determining the lease payments in a lease arrangement. Variable lease costs are expensed as incurred.
The incremental borrowing rate represents the interest rate at which the Company could borrow a fully collateralized amount equal to the lease payments, over a similar term, in a similar economic environment. The Company determines the incremental borrowing rate at lease commencement, generally using a synthetic credit rating based on the Company’s financial position and negative cash flows, factoring in adjustments for additional risks based on the Company’s economic condition, a survey of comparable companies with similar credit and financial profiles, as well as additional market risks, as may be applicable.
Right-of-use
assets represent the Company’s right to use an underlying asset over its lease term.
Right-of-use
assets are initially measured as the associated lease liability, adjusted for prepaid rent and tenant incentives. The Company remeasures
right-of-use
assets and lease liabilities when a lease is modified, and the modification is not accounted for as a separate contract. A modification is accounted for as a separate contract if the modification grants the Company an additional right of use not included in the original lease agreement and the increase in
 
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lease payments is commensurate with the additional right of use. The Company assesses its
right-of-use
assets for impairment consistent with its policy for impairment of long-lived assets held and used in operations.
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents
The Company considers all highly liquid investments that are readily convertible into cash with maturities of three months or less at the date of purchase to be cash equivalents. The Company maintains its cash in bank deposits accounts that are FDIC insured up the $250,000. At times, the Company’s bank accounts may exceed the federal insurance limits. Cash equivalents are comprised of money market accounts invested in U.S. Treasury securities.
Restricted cash and restricted cash equivalents are comprised of deposits held by financial institutions as collateral for the company’s venture debt and used to collateralize letters of credit related to the Company’s lease arrangements.
The company includes the restricted cash and restricted cash equivalents balance together with its cash and cash equivalents when reconciling
beginning-of-period
and
end-of-period
total amounts shown on the consolidated statements of cash flows.
Cash, cash equivalents, restricted cash and restricted cash equivalents consisted of the following (in thousands):
 
    
December 31,
 
    
2022
    
2021
 
Cash and cash equivalents
  
$
43,893
 
   $ 32,247  
Restricted cash and cash equivalents
  
 
5,647
 
     647  
  
 
 
    
 
 
 
Total cash, cash equivalents, restricted cash and restricted cash equivalents
  
$
49,540
 
   $ 32,894  
  
 
 
    
 
 
 
Impairment of Long-Lived Assets
The Company continually monitors events and changes in circumstances that could indicate carrying amounts of long-lived assets may be impaired, and assesses their recoverability based upon estimated future undiscounted future cash flows expected to be generated by the long-lived assets. If the estimated aggregate undiscounted cash flows are less than the carrying amount of the long-lived assets, an impairment charge, calculated as the amount by which the carrying amount of the assets exceeds the estimated fair value of the assets, is recorded. The estimated fair value of the long-lived assets is determined based on the estimated discounted cash flows expected to be generated from the long-lived assets.
Convertible notes
During 2022, the Company recognized a liability as a result of the issuance of convertible promissory notes (the Convertible Notes). The Company accounts for all Convertible Notes issued under the fair value option election of ASC 825,
Financial Instruments
(ASC 825). The financial instrument is initially measured at its issue-date estimated fair value and then subsequently remeasured at estimated fair value on a recurring basis at each reporting period date. The estimated fair value adjustment is recognized within other income (expense) in the accompanying consolidated statements of operations and the portion of the fair value adjustment attributed to a change in the instrument-specific credit risk is recognized as a component of other comprehensive loss, if any.
 
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Debt and Warrant Issuance Costs
The carrying value of the Company’s venture debt was recorded net of issuance costs and discount relating to the issuance of warrants. The amounts are amortized over the term of the debt using the effective interest method and recognized as interest expense.
Convertible Preferred Stock
The Company records all convertible preferred stock upon issuance at its respective fair value or original issuance price less issuance costs, as stipulated by its terms. The Company classifies its convertible preferred stock outside of stockholders’ deficit as the redemption of such shares is outside the Company’s control in certain circumstances, including upon liquidation or sale, as holders of the convertible preferred shares could cause redemption of the shares in these situations. The Company does not adjust the carrying value of the convertible preferred stock to redemption value until the contingent events that could give rise to redemption are considered probable of occurring.
Revenue Recognition
Under ASC Topic 606,
Revenue from Contracts with Customers
(Topic 606), an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer.
Once a contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations.
Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the customer and if so, they are considered performance obligations. The identification of material rights requires judgments related to the determination of the value of the underlying good or service relative to the option exercise price. The exercise of a material right is accounted for as a contract modification for accounting purposes.
The Company assesses whether each promised good or service is distinct for the purpose of identifying the performance obligations in the contract. This assessment involves subjective determinations and requires management to make judgments about the individual promised goods or services and whether such are separable from the other aspects of the contractual relationship. Promised goods and services are considered distinct provided that: (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (that is, the good or service is capable of being distinct) and (ii) the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (that is, the promise to transfer the good or service is distinct within the context of the contract). In assessing whether a promised good or service is distinct, the Company considers factors such as the license terms, the research, manufacturing and commercialization capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace. The Company also considers the intended benefit of the contract in assessing whether a promised good or service is separately identifiable from other promises in the contract. If a promised good or service is not distinct, an entity is required to combine that good or service with other promised goods or services until it identifies a bundle of goods or services that is distinct.
 
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The transaction price is determined and allocated to the identified performance obligations in proportion to their stand-alone selling prices (SSP) on a relative SSP basis. SSP is determined at contract inception and is not updated to reflect changes between contract inception and when the performance obligations are satisfied. Determining the SSP for performance obligations requires significant judgment. In developing the SSP for a performance obligation, the Company considers applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer and estimated costs. The Company validates the SSP for performance obligations by evaluating whether changes in the key assumptions used to determine the SSP will have a significant effect on the allocation of arrangement consideration between multiple performance obligations.
If the consideration promised in a contract includes a variable amount, the Company estimates the amount of consideration to which it will be entitled in exchange for transferring the promised goods or services to a customer. The Company determines the amount of variable consideration by using the expected value method or the most likely amount method. The amount of variable consideration included in the transaction price is constrained to the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty related to the variable consideration is resolved. At the end of each subsequent reporting period, the Company
re-evaluates
the estimated variable consideration included in the transaction price and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative
catch-up
basis in the period of adjustment.
If an arrangement includes development and regulatory milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s control or the licensee’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received.
For arrangements with licenses of intellectual property that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes royalty revenue and sales-based milestones at the later of (i) when the related sales occur, or (ii) when the performance obligation to which the royalty has been allocated has been satisfied.
In determining the transaction price, the Company adjusts consideration for the effects of the time value of money if the timing of payments provides the Company with a significant benefit of financing. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less.
The Company recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) each performance obligation is satisfied, either at a point in time or over time, and if over time recognition is based on the use of an output or input method.
Collaboration Arrangement
The Company analyzes first its collaboration arrangement to assess whether it is within the scope of FASB ASC Topic 808, Collaborative Arrangements (ASC 808) to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards that are dependent on the commercial success of such activities. To the extent the arrangement is within the scope of ASC 808, the Company assesses whether aspects of the arrangement between the Company and its collaboration partner are within the scope of other accounting literature, including ASC 606. If it is concluded that some or all aspects of the arrangement represent a transaction with a customer, the
 
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Company will account for those aspects of the arrangement within the scope of ASC 606. ASC 808 provides guidance for the presentation and disclosure of transactions in collaborative arrangements, but it does not provide recognition or measurement guidance.
Therefore, if the Company concludes a counterparty to a transaction is not a customer or otherwise not within the scope of ASC 606, the Company considers the guidance in other accounting literature, including the guidance in ASC 606, as applicable or by analogy to account for such transaction. The classification of transactions under the Company’s arrangements is determined based on the nature and contractual terms of the arrangement along with the nature of the operations of the participants.
Research and Development Expenses
Research and development costs are expensed as incurred. Research and Development expenses are comprised of costs incurred in performing research and development activities, including salaries, stock-based compensation and benefits, costs for clinical research organizations and other outsourced activities; laboratory supplies; technology licenses, software and other information technology support; facilities and depreciation.
Upfront payments and milestone payments made for the licensing of technology are expensed as research and development expenses in the period in which they are incurred. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed.
The Company has entered into various research and development related contracts with external parties. The payments under these agreements are recorded as research and development expenses as the underlying services are performed or the goods are received. The Company records accrued liabilities for estimated ongoing research costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the research activities, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. The Company’s historical accrual estimates have not been materially different from the actual costs.
Research and Development Tax Incentive
The Company is eligible under the AusIndustry Research and Tax Development Tax Incentive Program to obtain a cash amount from the Australian Taxation Office (ATO). The tax incentive is available to the Company on the basis of specific criteria with which the Company must comply related to research and development expenditures in Australia. The Company adopted on January 1, 2022, ASU
No. 2021-10,
Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance
. The Company applied a grant accounting model by analogy to IAS 20. The Company recognizes the Research and Development Tax Incentive (grant) as it incurs costs eligible for reimbursement under the AusIndustry Research and Tax Development Tax Incentive Program when it is reasonably assured that the grant funding will be received, as evidenced through enrollment in the program and when the applicable conditions under the program have been met. During the years ended December 31, 2022 and 2021, respectively, the Company recorded $0.4 million and $0.7 million of research and development tax incentives as contra-research and development expense over the periods in which the Company recognized the eligible research and development activities taking place in Australia.
Patent Costs
The Company expenses all costs as incurred in connection with patent applications, including direct application fees, and the legal and consulting expenses related to making such applications, and such costs are included in general and administrative expenses within the Company’s statement of operations.
 
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Stock-Based Compensation
The Company accounts for stock-based awards in accordance with ASC Topic 718,
Compensation – Stock Compensation
(ASC 718). ASC 718 requires all stock-based awards issued to employees and members of the Company’s board of directors for their services to be recognized as expense in the statements of operations based on their grant date fair values. The Company uses the value of its common stock to determine the fair value of its stock-based awards. For stock options and time-based restricted stock awards, the Company expenses the fair value of the awards on a straight-line basis over each award’s service period, which is generally the period in which the related services are received. For performance-based stock awards, the Company uses the accelerated attribution method to expense the awards over the implicit service period based on the probability of achieving the performance conditions. The Company accounts for stock-based awards to
non-employees
consistently with the accounting for awards to employees and measures stock-based awards granted to
non-employees
based on their grant date fair value and recognizes the resulting value as stock-based compensation expense during the period the related services are rendered. The Company has not issued any stock-based awards with market-based vesting conditions. The Company accounts for forfeitures as they occur.
The Company’s equity incentive plan allows for the issuance of restricted stock awards to employees and
non-employee
consultants that may be subject to vesting. The unvested shares of any restricted stock awards are held in escrow as the stock award vests or until award holder termination, whichever occurs first. In the event of a sale of the Company, the Company has the obligation to repurchase at cost, the portion of unvested stock awards from the award holder. For all unvested stock awards, a liability is established related to the Company’s obligation for unvested awards at cost.
Determination of Fair Value of Common Stock on Grant Dates
The fair value of each restricted common stock award is estimated on the date of grant based on the fair value of the Company’s common stock on that same date. The fair value of each option grant is estimated on the date of grant using the Black-Scholes option pricing model, which requires inputs based on certain subjective assumptions, including the fair value of the Company’s common stock, expected stock price volatility, the expected term of the award, the risk-free interest rate, and expected dividends (see Note 11). The Company has been a private company and lacks company-specific historical and implied volatility information for its stock. Therefore, it estimates its expected stock price volatility based on the historical volatility of publicly traded peer companies. The expected term of options was calculated using the simplified method, which represents the average of the contractual term of the option and the weighted-average vesting period of the option. The Company uses the simplified method because it does not have sufficient historical option exercise data to provide a reasonable basis upon which to estimate expected term. The expected term of options granted to
non-employees
is equal to the contractual term of the option award. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future.
Due to the absence of an active market for the Company’s common stock, the Company and the board of directors were required to determine the fair value of the Company’s common stock at the time of each grant of a stock-based award. The Company estimated the fair value of its common stock utilizing methodologies in accordance with the framework of the American Institute of Certified Public Accountants’ Technical Practice Aid,
Valuation of Privately-Held Company Equity Securities Issued as Compensation
. In determining the exercise prices for options granted, the Company has considered the estimated fair value of the common stock as of the measurement date. The estimated fair value of the common stock has been determined at each grant date based upon a variety of factors, including prices paid for the Company’s convertible preferred stock and the rights, preferences, and privileges of the Company’s Preferred Stock and common stock; the Company’s stage of development and status of technological developments within the Company’s research; the illiquid nature of securities in a private company; the prospects of a liquidity event; and the current business climate in the
 
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marketplace. Significant changes to the key assumptions underlying the factors used could result in different fair values of common stock at each valuation date. The Company’s common stock valuations were prepared using an option pricing method, or OPM. The OPM treats common stock and preferred stock as call options on the total equity value of a company, with exercise prices based on the value thresholds at which the allocation among the various holders of a company’s securities changes. Under this method, the common stock has value only if the funds available for distribution to stockholders exceeded the value of the preferred stock liquidation preferences at the time of the liquidity event, such as a strategic sale or a merger. A discount for lack of marketability of the common stock is then applied to arrive at an indication of value for the common stock. There are significant judgments and estimates inherent in the determination of the fair value of the Company’s common stock. These estimates and assumptions include a number of objective and subjective factors, including external market conditions, the prices at which the Company sold shares of preferred securities, the superior likelihood of, achieving a liquidity event, such as an IPO or sale. Significant changes to the key assumptions used in the valuations could result in different fair values of common stock at each valuation date.
The Company classifies stock-based compensation expense in its statements of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified.
Income Taxes
Income taxes are recorded in accordance with FASB ASC Topic 740,
Income Taxes
(ASC 740), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the consolidated financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. Should the actual amounts differ from these estimates, the amount of the Company’s valuation allowance could be materially impacted. Changes in these estimates may result in significant increases or decreases to the tax provision in a period in which such estimates are changed, which in turn would affect net income or loss.
Income taxes have been accounted for using the asset and liability method. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates applicable to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the period that includes the enactment date. A valuation allowance against deferred tax assets is recorded if, based upon the weight of all available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.
The Company accounts for uncertainty in income taxes recognized in the consolidated financial statements by applying a
two-step
process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed
more-likely-than-not
to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the consolidated financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties.
 
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Comprehensive Income (Loss)
Comprehensive loss includes net loss as well as other changes in stockholders’ equity (deficit) that result from transactions and economic events other than those with stockholders. There was no difference between net loss and comprehensive loss for each of the periods presented in the accompanying financial statements.
Net Loss per Share Attributable to Common Stockholders
Net loss per share attributable to common stockholders is determined using the
two-class
method, which is an earnings allocation formula that determines net loss per share for the holders of the Company’s common shares and participating securities. The Company’s preferred stock contains participation rights in any dividend paid by the Company and is deemed to be a participating security. In periods of income, the convertible preferred stock would be considered participating securities because the shares include rights to participate in dividends with the common stock; however, the convertible preferred stock is not considered a participating security in periods of loss as they do not have an obligation to share in the Company’s net losses and are not included in the calculation of net loss per share in the periods in which a net loss is recorded. Net loss attributable to common stockholders is equal to the net loss for the period.
Diluted net loss per share is computed using the more dilutive of (a) the
two-class
method or (b) the treasury stock method and
if-converted
method. The Company allocates earnings first to preferred stockholders based on dividend rights and then to common and preferred stockholders based on ownership interests. The weighted-average number of common shares included in the computation of diluted net loss gives effect to all potentially dilutive common equivalent shares, including outstanding stock options and Preferred Stock. Common stock equivalent shares are excluded from the computation of diluted net loss per share if their effect is antidilutive. In periods in which the Company reports a net loss attributable to common stockholders, diluted net loss per share attributable to common stockholders is generally the same as basic net loss per share attributable to common stockholders since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive.
Subsequent Event Considerations
The Company considers events or transactions that occur after the balance sheet date but prior to the issuance of the financial statements to provide additional evidence for certain estimates or to identify matters that require additional disclosure. The Company has evaluated events occurring after the date of its consolidated balance sheet through December 15, 2023, the date of these consolidated financial statements were available to be issued. See Note 17.
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.
In May 2021, the FASB issued ASU
No. 2021-04,
Earnings Per Share (Topic 260), Debt – Modifications and Extinguishments (Subtopic
470-50),
Compensation – Stock Compensation (Topic 718), and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic
815-40)
. This standard has an effective and transition date of January 1, 2022. This standard clarifies and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options, including warrants, that remain equity-classified after modification or exchange. The standard requires an entity to treat a modification or an exchange of a freestanding equity-classified written call option that remains equity-classified after the modification or exchange as an exchange of the original instrument for a new instrument. The standard additionally provides guidance on measuring and recognizing the effect of a modification or an exchange. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements.
 
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In November 2021, the FASB issued ASU
No. 2021-10,
Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance.
This standard has an effective and transition date of January 1, 2022. This standard increases the transparency of transactions with the government that are accounted for by applying a grant or contribution accounting model, and aims to reduce diversity that currently exists in the recognition, measurement, presentation, and disclosure of government assistance received by business entities due to the lack of specific authoritative guidance in GAAP. This standard requires an entity to provide information regarding the nature of the transaction with a government and the related accounting policy used to account for this transaction, the line item on the consolidated balance sheet and consolidated statement of operations and comprehensive loss that are affected by the transaction and the amounts applicable to each financial statement line item, and the significant terms and conditions of the transaction, including commitments and contingencies. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements.
In August 2020, the FASB issued ASU
No. 2020-06,
Debt – Debt with Conversion and Other Options (Subtopic
470-20)
and Derivatives and Hedging Contracts in Entity’s Own Equity (Subtopic
815-40)
(ASU
2020-06),
which reduces the number of accounting models for convertible debt instruments and convertible preferred stock as well as amends the derivatives scope exception for contracts in an entity’s own equity. ASU
2020-06
is effective for the Company on January 1, 2024, with early adoption permitted. The Company early adopted on January 1, 2022. The early adoption of this standard did not have a material impact on the Company’s consolidated financial statements.
Recently Issued Accounting Standards Not Yet Adopted
In June 2016, the FASB issued ASU
No. 2016-13,
Financial Instruments – Credit Losses (Topic 326) – Measurement of Credit Losses on Financial Instruments,
which has been subsequently amended by ASU
No. 2018-19,
ASU
No. 2019-04,
ASU
No. 2019-05,
ASU
No. 2019-10,
ASU
No. 2019-11
and ASU
No. 2020-03
(ASU
2016-13).
The provisions of ASU
2016-13
modify the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology and require a consideration of a broader range of reasonable and supportable information to inform credit loss estimates. ASU
2016-13
is effective for the Company on January 1, 2023, with early adoption permitted. The adoption of this standard is not expected to have a material impact on the Company’s consolidated financial statements and related disclosures.
3. Fair Value Measurements
The carrying values of the Company’s prepaid expenses and other current assets, accounts payable, and accrued expenses and other current liabilities approximate their fair value due to their short-term nature. The carrying value of the Company’s term loan as of December 31, 2022 (see Note 8) approximated fair value based on interest rates currently available to the Company.
The tables below presents information about the Company’s assets and liabilities that are regularly measured and carried at fair value on a recurring basis at December 31, 2022 and 2021 and indicate the level within the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value, which is described further within Note 2, Summary of Significant Accounting Policies.
 
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Financial assets and liabilities measured at fair value on a
recurring
basis as of
December 31, 2022
are summarized as follows (in thousands):
 
Description
  
Balance as of

December 31,

2022
    
Quoted Prices in

Active Markets

(Level 1)
    
Significant Other

Observable

Inputs (Level 2)
    
Significant

Other

Unobservable

Inputs (Level 3)
 
Assets
           
Cash equivalents:
           
Money market funds
   $ 42,496      $ 42,496      $ —        $ —    
  
 
 
    
 
 
    
 
 
    
 
 
 
Restricted cash equivalents:
           
Money market funds
   $ 5,000      $ 5,000        
  
 
 
    
 
 
    
 
 
    
 
 
 
Total
   $ 47,496      $ 47,496      $ —        $ —    
  
 
 
    
 
 
    
 
 
    
 
 
 
Liabilities
           
Convertible Notes
   $ 32,402      $ —        $ —        $ 32,402  
  
 
 
    
 
 
    
 
 
    
 
 
 
Total
   $ 32,402      $ —        $ —        $ 32,402  
  
 
 
    
 
 
    
 
 
    
 
 
 
Financial assets and liabilities measured at fair value on a recurring basis as of December 31, 2021 are summarized as follows (in thousands):
 
Description
  
Balance as of

December 31,

2021
    
Quoted Prices in

Active Markets

(Level 1)
    
Significant Other

Observable

Inputs (Level 2)
    
Significant

Other

Unobservable

Inputs (Level 3)
 
Assets
           
Cash equivalents:
           
Money market funds
   $ 29,899      $ 29,899      $ —        $ —    
  
 
 
    
 
 
    
 
 
    
 
 
 
Total
   $ 29,899      $ 29,899      $ —        $ —    
  
 
 
    
 
 
    
 
 
    
 
 
 
Money market funds were valued by the Company using quoted prices in active markets for identical securities, which represent a Level 1 measurement within the fair value hierarchy. During the years ended December 31, 2022 and 2021, there were no transfers between Level 1, Level 2 and Level 3. There have been no impairments of the Company’s assets measured and carried at fair value during the years ended December 31, 2022 and 2021.
The Company issued convertible notes (Convertible Notes) totaling $30,000,000 during the year ended December 31, 2022. The Company concluded that the Convertible Notes and its related features are within the scope of ASC 825,
Financial Instruments
, as a combined financial instrument, and the Company elected the fair value option where changes in fair value of the Convertible Notes are measured through the accompanying consolidated statement of operations and comprehensive loss until settlement. The Convertible Notes liability represents a Level 3 measurement within the fair value hierarchy as it has been valued using certain unobservable inputs. These inputs include the underlying fair value of the equity instrument into which the Convertible Notes are convertible. The fair value is based on significant inputs not observable in the market, namely potential financing scenarios, the likelihood of such scenarios, the expected time for each scenario to occur, and the required market rates of return utilized in modeling these scenarios.
 
Year ending
December 31, 2022
  
Scenario 1
   
Scenario 2
 
Probability of each scenario
     76.4 %      23.6 % 
Expected Term (years)
     0.75       0.75  
Required market rates of return
     15.0 %      15.0 % 
 
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The Convertible Notes had an estimated fair value of $32.4 million as of December 31, 2022. The Company recorded a charge of $2.4 million on the change in estimated fair value during the year ended December 31, 2022. There was no change in fair value attributable to the instrument-specific credit risk for the year ended December 31, 2022.
4. Property and Equipment, Net
Property and equipment, net consisted of the following as of (in thousands):
 
    
December 31,
 
    
2022
    
2021
 
Lab equipment
  
$
1,382
 
   $ 220  
Furniture and fixtures
  
 
341
 
     —    
Computer equipment
  
 
85
 
     85  
Leasehold improvements
  
 
935
 
     —    
  
 
 
    
 
 
 
Total property and equipment
  
 
2,743
 
     305  
Less accumulated depreciation
  
 
(467
) 
     (102 ) 
  
 
 
    
 
 
 
Property and equipment, net
  
$
2,276
 
   $ 203  
  
 
 
    
 
 
 
Depreciation expense for the years ended December 31, 2022 and 2021 was $370 thousand and $47 thousand, respectively. No impairment losses occurred in 2022 and 2021. The Company had a loss on disposal of fixed assets of $23 thousand for the year ended December 31, 2022.
5. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following as of (in thousands):
 
    
December 31,
 
    
2022
    
2021
 
Payroll tax credit
  
$
948
 
   $ 627  
Prepaid external research and development
  
 
1,329
 
     529  
Research credit receivable
  
 
116
 
     282  
Prepaid expenses
  
 
421
 
     240  
Other
  
 
146
 
     73  
  
 
 
    
 
 
 
Total prepaid expenses and other current assets
  
$
2,960
 
   $ 1,751  
  
 
 
    
 
 
 
6. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following as of (in thousands):
 
    
December 31,
 
    
2022
    
2021
 
Accrued external research and development
  
$
4,077
 
   $ 2,477  
Accrued compensation and related expenses
  
 
2,791
 
     1,489  
Accrued interest
  
 
376
 
     —    
Accrued taxes payable
  
 
570
 
     —    
Operating lease liability, current
  
 
471
 
     —    
Accrued professional services and other
  
 
1,212
 
     574  
  
 
 
    
 
 
 
Total accrued expenses and other current liabilities
  
$
9,497
 
   $ 4,540  
  
 
 
    
 
 
 
 
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7. Commitments and Contingencies
As of December 31, 2022, the Company has several ongoing clinical studies in various clinical trial stages. Its most significant contracts relate to agreements with clinical research organizations (CROs) for clinical trials and preclinical studies and contract development and manufacturing organizations (CMOs), which the Company enters into in the normal course of business. The contracts with CROs and CMOs are generally cancellable, with notice, at the Company’s option.
Operating lease
The Company maintained a
month-to-month
operating lease agreement for its office and laboratory space until the company moved to its current corporate headquarters in Waltham, Massachusetts. The lease for the Company’s corporate headquarters provides approximately 15,000 rentable square feet for general office use and research lab facilities. The lease commencement date began on January 1, 2022 and the Company did not take control or have the right to use the leased property until this time. The lease term ends in December 2031. The Company has an option to extend the lease term for an additional five years. The initial rent for the office space is approximately $970 thousand per year, increasing every year by 3% for total aggregate payment of $11.1 million. Upon the commencement date, the Company established a
right-of-use
asset and lease liability on the consolidated balance sheet. As part of the agreement, the Company arranged for a letter of credit for $647 thousand as a security for lease, which is considered restricted cash and included as restricted cash and restricted cash equivalents in the consolidated balance sheet. The Company received $0.4 million in a tenant improvement allowance that was applied against the
right-of-use
asset. Rent expense for the years ended December 31, 2022 and 2021 was $1.3 million and $0.6 million, respectively.
As of December 31, 2022, the Company’s operating lease had a weighted-average remaining lease term of nine years and weighted average incremental borrowing rate of 7.5%.
Amounts reported in the consolidated balance sheet for leases where the Company is the lessee as of December 31, 2022 and 2021 were as follows (in thousands):
 
    
December 31,
 
    
2022
    
2021
 
Assets:
                 
Operating lease
right-of-use
assets
  
$
6,890
 
   $ —    
    
 
 
    
 
 
 
Total operating lease
right-of-use
assets
  
$
6,890
 
   $ —    
    
 
 
    
 
 
 
Liabilities:
                 
Current:
                 
Operating lease liabilities
  
$
471
 
   $ —    
Noncurrent:
                 
Operating lease liabilities, net of current portion
  
 
6,786
 
  
 
—  
 
    
 
 
    
 
 
 
Total operating lease liabilities
  
$
7,257
 
   $ —    
    
 
 
    
 
 
 
The following table summarizes operating lease costs for the years ended December 31, 2022 and 2021 (in thousands):
 
    
December 31,
 
    
2022
    
2021
 
Fixed lease costs
  
$
1,232
 
   $ —    
Variable lease costs
  
 
103
 
     —    
Short-term lease costs
  
 
—  
 
  
 
642
 
    
 
 
    
 
 
 
Total lease costs
  
$
1,335
 
   $ 642  
    
 
 
    
 
 
 
 
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Future minimum lease payments under
non-cancelable
lease agreement as of December 31, 2022 and a reconciliation to the carrying amount of the lease liabilities presented in the consolidated balance sheet are as follows (in thousands):
 
    
Minimum
Rental
Payments
 
2023
   $ 999  
2024
     1,029  
2025
     1,060  
2026
     1,092  
2027
     1,124  
Thereafter
     4,845  
    
 
 
 
Total minimum lease payments
     10,149  
Less imputed interest
     (2,892 ) 
    
 
 
 
Total lease liability
   $ 7,257  
    
 
 
 
Lease liability, current portion
   $ 471  
Lease liability, net of current portion
     6,786  
    
 
 
 
Total
   $ 7,257  
    
 
 
 
License Agreements
License Agreement with the University of Colorado
In August 2017, the Company entered into an exclusive license agreement, as amended in February 2018, September 2018, and April 2019 (the Colorado License Agreement), with The Regents of the University of Colorado (Colorado), pursuant to which the Company obtained worldwide, royalty-bearing, sublicensable licenses under certain patents and
know-how
owned by Colorado and Medical University of South Carolina (MUSC) relating to the research, development and commercialization of
ADX-097.
The licenses granted to the Company are exclusive with respect to certain patent families and
know-how
and
non-exclusive
with certain other patent families and
know-how.
The licenses granted to the Company are also subject to certain customary retained rights of Colorado and MUSC and rights of the United States government owing to federal funding giving rise to inventions covered by the licensed patents. the Company agreed to use commercially reasonable efforts to develop, manufacture and commercialize
ADX-097,
including by using commercially reasonable efforts to achieve specified development and regulatory milestones by specified dates.
In addition, the Company agreed to pay Colorado (i) development and sales milestone payments in an aggregate amount of up to $2.2 million per licensed product for the first three products, (ii) tiered royalty rates on cumulative net sales of licensed products in the low single digit percentages, (iii) 15% of sublicense income and (iv) ongoing fees associated with the prosecution, maintenance, or filing of the licensed patents. the Company’s obligation to pay royalties to Colorado commences, on a licensed
product-by-licensed
product and
country-by-country
basis, from the first commercial sale of a licensed product in any country and expires on the later of (a) the last to expire valid claim within the licensed patents covering such licensed product in such country, and (b) 20 years following the effective date of the Colorado License Agreement, or April 2037 (the Royalty Term).
Unless earlier terminated by either party pursuant to its terms, the Colorado License Agreement will expire upon the expiration of the Royalty Term in all countries. The Company may terminate the Colorado License Agreement for convenience upon providing prior written notice to Colorado. Colorado may terminate the Colorado License Agreement or convert the Company’s exclusive license to a
non-exclusive
license if the Company breaches certain obligations under the Colorado License Agreement and fails to cure such breach. The Colorado License Agreement will terminate automatically upon the Company’s dissolution, insolvency, or bankruptcy.
 
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During the years ended December 31, 2022 and 2021, the Company recorded research and development expense of $50 thousand and zero, respectively for milestone related to the Colorado License Agreement. The financial statements as of December 31, 2022 and 2021 do not include liabilities with respect to royalty fees on the license agreement as the Company has not yet generated revenue and the achievement of certain milestones is not yet probable.
License Agreement with Bristol-Myers Squibb Company
In September 2019, the Company entered into a license agreement, as amended in August 2021 and July 2022 (the BMS License Agreement), with Bristol-Myers Squibb Company (BMS), pursuant to which the Company obtained sublicensable licenses from BMS to research, develop and commercialize licensed products, including bempikibart, for any and all uses worldwide. The licenses granted to the Company are exclusive with respect to BMS’s patent rights and
know-how
relating to certain antibody fragments (including certain fragments of bempikibart) and
non-exclusive
with respect to BMS’s patent rights and
know-how
relating to the composition of matter and use of a specific region of bempikibart. BMS retained the right for it and its affiliates to use the exclusively licensed patents and
know-how
for internal, preclinical research purposes. Under the BMS License Agreement, the Company is prohibited from engaging in certain clinical development or commercialization of any antibody other than a licensed compound with the same mechanism of action until the earlier of the expiration of Q32’s obligation to pay BMS royalties or September 2029.
In consideration for the license, the Company made an upfront payment to BMS of $8 million, issued 6,628,788 Series A preferred shares to BMS and agreed to use commercially reasonable efforts to develop and commercialize at least one licensed product in key geographic markets. In addition, the Company agreed to pay BMS (i) development and regulatory milestone payments in aggregate amounts ranging from $32 million to $49 million per indication for the first three indications and commercial milestone payments in an aggregate amount of up to $215 million on net sales of licensed products, (ii) tiered royalties ranging from rates in the
mid-single
digit percentages to up to 10% of net sales, with increasing rates depending on the cumulative net sales, (iii) up to 60% of sublicense income, which percentage decreases based on the development stage of bempikibart at the time of the sublicensing event, and (iv) ongoing fees associated with the prosecution, maintenance, or filing of the licensed patents.
The Company’s obligation to pay BMS royalties under subsection (ii) above commences, on a licensed
product-by-licensed
product and
country-by-country
basis on the first commercial sale of a licensed product in a country and expires on the later of (x) 12 years from the first commercial sale of such Licensed Product in such country, (y) the last to expire licensed patent right covering bempikibart or such licensed product in such country, and (z) the expiration or regulatory or marketing exclusivity for such licensed product in such country (Royalty Term). If the Company undergoes a change of control prior to certain specified phase of development, the development and milestone payments are subject to increase by a low double digit percentage and the royalty rates are subject to increase by a low sub single digit percentage.
Unless terminated earlier by either party pursuant to its terms, the BMS License Agreement will expire on a
country-by-country
and licensed
product-by-licensed
product basis upon the expiration of the last to expire Royalty Term with respect to such licensed product in such country. Either party may terminate the BMS License Agreement for the other party’s material breach, subject to a specified notice and cure period. BMS may terminate the BMS License Agreement if the Company fails to meet its diligence obligations under the BMS License Agreement, for the Company’s insolvency, or if the Company or its affiliates challenges the validity, scope, enforceability, or patentability of any of the licensed patents. The Company may terminate the BMS License Agreement for any reason upon prior written notice to BMS, with a longer notice period if a licensed product has received regulatory approval. If the BMS Agreement is terminated for the Company’s material breach, BMS will regain rights to bempikibart and the Company must grant BMS an exclusive license under the Company’s patent rights covering bempikibart, subject to a low single digit percentage royalty on net sales of bempikibart payable to the Company by BMS.
 
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During the year ended December 31, 2019, the Company recorded
in-process-research
and development expense of $14.6 million in the statement of operations related to the BMS License Agreement comprised of $8.0 million of cash consideration and $6.6 million of Series A preferred shares issued to BMS.
As of December 31, 2022, no events have occurred that would require payment of the milestones, royalties or sublicense fees.
Legal Proceedings
The Company is not currently party to any material legal proceedings. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of FASB ASC Topic 450,
Contingencies
. The Company expenses as incurred the costs related to its legal proceedings.
Indemnification Arrangements
As permitted under Delaware law, the Company has agreements whereby it indemnifies certain of its investors, stockholders, employees, officers, and directors (collectively, the Indemnified Parties) for certain events or occurrences while the Indemnified Parties are, or were serving, at its request in such capacity. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is unlimited; however, the Company has an Executive Liability insurance policy that limits its exposure and enables it to recover a portion of any future amounts paid up to $5.0 million. The Company believes the estimated fair value of these indemnification agreements is minimal. The Company enters into standard indemnification agreements in the ordinary course of business. Pursuant to these agreements, the Company indemnifies, holds harmless, and agrees to reimburse the Indemnified Parties for losses suffered or incurred by the Indemnified Parties, generally the Company’s business partners or customers, in connection with any U.S. patent or any copyright or other intellectual property infringement claim by any third party with respect to the Company’s products. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is unlimited. The Company has never incurred costs to defend lawsuits or settle claims related to these indemnification agreements.
8. Debt
Venture Debt
On December 11, 2020, the Company entered into a Loan and Security Agreement with Silicon Valley Bank, a California corporation (Loan Agreement) for a lending facility of up to $25 million. The Company received $5.0 million upon execution of the Agreement (2020 Term A Loan Advance) and had the ability to draw up to $20.0 million in three separate term loan advances if certain performance milestones are met. The term loan bears interest at an annual rate equal to the greater of the prime rate or 3.25%. The Loan Agreement provides for interest-only payments until April 30, 2022, and repayment of the aggregate outstanding principal balance of the term loan in monthly installments starting on July 1, 2022 through December 1, 2023. The commencement of principal payments and the maturity date will be deferred by one year upon the occurrence of a contingent event. In addition, the Company paid a fee of $91 thousand upon closing and is required to pay a fee of 2.0% of the aggregate amount of advances under the Loan Agreement at maturity. At its option, the Company may elect to prepay all or a portion of the outstanding advances by paying the principal balance, and all accrued and unpaid interest, and a prepayment premium. In connection with the Loan Agreement, the Company granted the lender a security interest in all of its personal property now owned or hereafter acquired, excluding intellectual property (but including the rights to payment and proceeds from the sale, licensing or disposition of intellectual property), and a negative pledge on intellectual property. The Loan Agreement also contains certain events of default, representations, warranties and
non-financial
covenants of the Company. If the Company fails to make payments when due or breaches any operational covenant or has any event of default, this could have a material adverse effect on its business and financial condition. The Company was in compliance with all covenants at December 31, 2022.
 
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On June 30, 2022, a second amendment to the Loan Agreement was entered into with the lender that extended the interest-only payment until December 31, 2022 followed by 24 equal monthly payments of principal plus interest. The loan matures on December 31, 2024. The amendment increases the final payment from 2.0% to 4.0% of the advanced payment and modifies the prepayment premium.
On August 10, 2022, a third amendment to the Loan Agreement was entered into with the lender. Per the terms of the amendment and in conjunction with the Collaboration Agreement (as defined below), the Company transferred $5.0 million into a restricted cash collateral money market account which is included as Restricted cash and restricted cash equivalents on the balance sheet. This restricted cash equivalent covers the amount of the debt outstanding as of the third amendment effective date.
On December 21, 2022, a fourth amendment to the Loan Agreement was entered into with the lender that extended the interest-only payment until July 1, 2023 followed by 18 equal monthly payments of principal plus interest. The loan matures on December 1, 2024.
On April 26, 2023, a fifth amendment to the Loan Agreement was entered into with the lender. The amendment provides that the Company must maintain at least 50% of its consolidated cash with the lender. In addition, the Company shall at all times have on deposit in operating and depository accounts maintained with the lender, unrestricted and unencumbered cash in an amount equal to the lesser of (i) 100% of the dollar value of the Company’s consolidated cash and (ii) 110% of the then-outstanding obligations of the Company to the bank. So long as, the Company is in compliance with those terms, the Company shall be permitted to maintain accounts with other banks or financial institutions.
On July 12, 2023, a sixth amendment to the Loan Agreement was entered into with the lender. The amendment provides for one term loan advance (the 2023 Term A loan advance) in an original principal amount of $5.5 million and required the Company to repay the outstanding 2020 Term A Loan Advance of $5.0 million, including the final payment of $0.2 million. Upon the occurrence of a contingent event, the lender shall make up to three additional term loan advances at the Company’s request in original principal amounts of $7.0 million, $7.5 million and $5.0 million. The amounts must be drawn by the Company before March 31, 2024, March 31, 2025 and July 1, 2025, respectively. The interest-only period extends through June 30, 2024 followed by 36 equal monthly payments of principal plus interest. The term loan bears interest at an annual rate equal to the greater of the prime rate minus 0.25% or 8.00%. Pursuant to this amendment, specifically the interest-only period through June 30, 2024, the Company classified the principal of its venture debt as noncurrent on the consolidated balance sheet as of December 31, 2022.
In conjunction with the Loan Agreement, the Company issued warrants to purchase 166,371 shares of common stock to the lender at a per share price of $0.33 with a maximum contractual term of 10 years. The warrants had a total relative fair value of $39 thousand upon issuance and were recorded as a debt discount.
In conjunction with the sixth amendment, the Company issued warrants to purchase 211,528 shares of common stock to the lender at a per share price of $0.36 with a maximum contractual term of 10 years. The warrants are issued in two separate tranches of 105,764 based upon certain milestone events. The warrants had a de minimis total relative fair value at the time of issuance.
Pursuant to ASC Topic 480,
Distinguishing Liabilities from Equity
and ASC Topic 815,
Derivatives and Hedging
, the Warrants were classified as equity and were initially measured at fair value. Subsequent changes to fair value will not be recognized so long as the instrument continues to be equity classified.
Interest expense was $327 thousand and $263 thousand for the years ended December 31, 2022 and 2021, respectively. The effective rate on the Loan Agreement, including the amortization of the debt discount and
 
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issuance costs was 9.49% and 5.23% at December 31, 2022 and 2021, respectively. The components of the long-term debt balance are as follows (in thousands):
 
    
December 31,
 
    
2022
    
2021
 
Principal amount of term loans
  
$
5,000
 
   $ 5,000  
Unamortized debt discount and issuance costs
  
 
72
 
     (28 ) 
  
 
 
    
 
 
 
Carrying amount
  
 
5,072
 
     4,972  
Less current portion
  
 
—  
 
     —    
  
 
 
    
 
 
 
Long-term debt, net
  
$
5,072
 
   $ 4,972  
  
 
 
    
 
 
 
Convertible Notes
On May 20, 2022, the Company entered into an agreement with the existing investors of the Company to purchase up to an aggregate of $30.0 million in convertible notes (the Convertible Notes). The Convertible Notes bear interest at 5.0% per annum. The Convertible Notes become due on demand of the Convertible Noteholders one year from the date of issuance. On May 20, August 5 and December 23, 2022, the Company received $8.3 million, $5.0 million, and $16.7 million, respectively, in exchange for issuance of the Convertible Notes. Interest expense was $376 thousand for the year ended December 31, 2022.
The Convertible Notes contain mandatory conversion features whereby the total outstanding amount of principal and accrued and unpaid interest of the Convertible Notes shall automatically convert into shares of common stock upon certain qualified financings. The total outstanding amount of principal and accrued and unpaid interest of the Convertible Notes convert into common shares at 90% of the purchase price of the mandatory conversion events. If the mandatory conversion events do not occur the holders of the Convertible Notes may request the Convertible Notes plus accrued interest be converted into Series B preferred stock at the Series B convertible price of $1.0971.
The Company has elected to account for the Convertible Notes at fair value. The Company recorded a $2.4 million loss related to the change in the fair value of the Convertible Notes for the year ended December 31, 2022.
9. Convertible Preferred Stock
In July 2018, the Company entered into a Series A and
A-1
Preferred Stock Purchase Agreement and issued 10,000,000 shares of Series A Preferred Stock at a price of $1.00 per share less issuance costs of $100 thousand for total net proceeds of $9.9 million. The Company also issued 6,500,000 shares of Series A1 preferred stock for the conversion of financial instruments that had been previously issued during the years ended December 31, 2018 and 2017.
In connection with the initial issuance of the Series A preferred stock, the holders received the right to purchase, and the Company the obligation to sell, an additional 31,000,000 shares of Series A preferred stock at the same purchase price as the initial closing upon achieving certain milestones. The specified milestones could be waived upon written consent of the holders of a majority of the shares of Series A preferred stock. The Company determined that the tranche rights did not meet the definition of a freestanding financial instrument because they are not legally detachable. Further, the Company determined that the tranche rights do not meet the definition of an embedded derivative that require bifurcation from the equity instrument.
In August 2019, the Company issued 3,000,000 shares of Series A preferred stock at a price of $1.00 per share less issuance costs of $30 thousand for net proceeds of $2.97 million upon the achievement of specified milestones. In September 2019, the Company issued 28,000,000 shares of Series A preferred stock at a price of $1.00 per share less issuance costs of $40 thousand for net proceeds of $27.96 million upon the receipt of a waiver of the final milestones being met.
 
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In September 2019, the Company issued 6,628,788 Series A preferred shares in association with the purchase of a license agreement with BMS as further described in Note 7.
On August 31, 2020, the Company entered into a Series B Preferred Stock Purchase Agreement and issued 34,636,767 shares of Series B Preferred Stock at a price of $1.0971 per share less issuance costs of $100 thousand for total net proceeds of $37.9 million.
In connection with the initial issuance of the Series B preferred stock, the holders received the right to purchase, and the Company the obligation to sell, an additional 17,318,383 shares of Series B preferred stock at the same purchase price as the initial closing upon achieving certain milestones. The specified milestones could be waived upon written consent of the holders of a majority of the shares of Series B preferred stock. The Company also had the right to issue additional shares of Series B Preferred Stock to new investors if the agreement was reached before December 31, 2020, a portion of which would be issued immediately and a portion upon achieving the specified milestones. The Company determined that the tranche rights did not meet the definition of a freestanding financial instrument because they are not legally detachable. Further, the Company determined that the tranche rights do not meet the definition of an embedded derivative that require bifurcation from the equity instrument.
On October 15, 2020, the Company issued an additional 1,822,987 shares of Series B Preferred Stock to new investors at a purchase price of $1.0971 per share for total net proceeds of $2.0 million.
In November and December of 2021, the Company issued 18,229,873 shares of Series B Preferred stock at a purchase price of $1.0971 per share less issuance cost of $10 thousand for total net proceeds of $ for $20.0 million upon the achievement of the specified milestones.
The Series A Preferred stock, the Series
A-1
preferred stock and the Series B preferred stock, (together the Preferred Stock) have the following rights and preferences:
Voting Rights
The holders of the Preferred Stock are entitled to vote, together with the holders of common stock, on all matters submitted to stockholders for a vote. Each holder of outstanding shares of Preferred Stock shall be entitled to cast the number of votes equal to the number of shares of common stock into which the shares of Preferred Stock held by such holder are convertible at the time of such vote. Except as provided by law or by the other provisions of the Company’s Second Amended and Restated Certificate of Incorporation, holders of Preferred Stock vote together with the holders of common stock as a single class and on an
as-converted
to Common Stock basis.
The holders of record of the shares of Series B Preferred Stock, exclusively and as a separate class, are entitled to elect two directors of the Company (the Series B Preferred Directors); the holders of record of the shares of Series A Preferred Stock, exclusively and as a separate class, are entitled to elect three directors of the Company (the Series A Preferred Directors and together with the Series B Directors, the Preferred Directors).
Conversion
Each share of Preferred Stock is convertible, at the option of the holder, at any time, and without the payment of additional consideration, into such number of fully paid and
non-assessable
shares of common stock as is determined by dividing the Applicable Preferred Stock Original Issue Price (as defined below) by the Applicable Preferred Stock Conversion Price (as defined below) in effect at the time of conversion.
The Applicable Preferred Stock Original Issue Price is $1.00 per Series A share, $0.885 per Series A1 share and $1.0971 per Series B share, subject to appropriate adjustment in the event of any stock dividend, stock split, combination, or other similar recapitalization with respect to the Preferred Stock. The Applicable Preferred Stock
 
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Conversion Price is initially $1.00 for Series A, $0.885 for Series A1 and $1.0971 for Series B, subject to appropriate adjustment in the event of any stock dividend, stock split, combination, or other similar recapitalization and other adjustments, as set forth in the Company’s Second Amended and Restated Certificate of Incorporation.
Each share of Preferred Stock will automatically convert into shares of common stock at the then effective conversion ratio (i) upon an initial public offering of the Company’s common stock, provided that such offering results in at least $50 million of gross proceeds, after deducting the underwriting discount and commissions, to the Company or (ii) upon the vote or written consent of the holders of a majority of the outstanding shares of Preferred Stock.
Dividends
The Company may not declare, pay or set aside any dividends on any other class or series of stock of the Company, other than dividends on common stock payable in common stock, unless the holders of the Preferred Stock first receive, or simultaneously receive, a dividend on each outstanding Preferred Stock of an amount equal to six percent (6%) of the applicable preferred stock original issue price (as defined below) per share of such series of Preferred Stock (subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to such series of Preferred Stock). Dividends are
non-cumulative.
No cash dividends were declared or paid during the years ended December 31, 2022 or 2021.
Liquidation Preference
In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company or Deemed Liquidation Event (as defined below), the holders of shares of Preferred Stock then outstanding shall be entitled, on a pari passu basis, to be paid out of the assets of the Company available for distribution to its stockholders before any payment will be made to the holders of common stock by reason of their ownership thereof, an amount per share equal to with respect to the Series A, A1 and B preferred stock, one times the original issue price, plus any dividends declared but unpaid. If upon any such liquidation, dissolution or winding up of the Company or Deemed Liquidation Event, the assets of the Company available for distribution to its stockholders shall be insufficient to pay the holders of shares of Preferred Stock the full amount to which they shall be entitled, the holders of the shares of Preferred Stock shall share ratably in any distribution of the assets available for distribution in proportion to the respective amounts which would otherwise be payable in respect of the shares held by them upon such distribution if all amounts payable on or with respect to such shares were paid in full.
After the payment of all preferential amounts required to be paid to the holders of shares of Preferred Stock, the remaining assets of the Company available for distribution to its stockholders will be distributed among the holders of the shares of Series A, A1 and B preferred stock, and common stock, pro rata based on the number of shares held by each such holder, treating for the purpose all such securities as if they had been converted to common stock. Unless the holders of a majority of the Preferred Stock, voting together as a single class, elect otherwise, a Deemed Liquidation Event shall include (i) a merger or consolidation (other than one in which stockholders of the Company own a majority by voting power of the outstanding shares of the surviving or acquiring corporation) or (ii) a sale, lease, transfer, exclusive license, or other disposition of substantially all of the assets of the Company.
Redemption
The Preferred Stock is not redeemable at the option of the holders thereof. However, the Preferred Stock is redeemable upon the occurrence of certain contingent events, unless otherwise determined by the holders.
As it relates to the payment upon the occurrence of a contingent event, the Company evaluated the Preferred Stock in accordance with the guidance in FASB ASC Topic 480,
Distinguishing Liabilities from Equity
, and
 
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determined that the payment upon the occurrence of a contingent event is not solely within its control and accordingly classified the Preferred Stock in temporary equity. The Preferred Stock is not currently redeemable, nor is it currently probable that the instruments will become redeemable, and therefore the instruments are not accreted to redemption value.
10. Common Stock
As of December 31, 2022 the Company’s Second Amended and Restated Certificate of Incorporation authorized the Company to issue 141,900,000 shares of common stock, $0.0001 par value per share, respectively. The voting, dividend and liquidation rights of the holders of the Company’s common stock are subject to and qualified by the rights, powers and preferences of the holders of the Preferred Stock set forth above. Each share of common stock entitles the holder to one vote, together with the holders of the Preferred Stock, on all matters submitted to the stockholders for a vote. On May 20, 2022 and December 8, 2022, the Company amended and restated the Certificate of Incorporation to increase the authorized common stock by 5,000,000 and 6,900,000, respectively to 141,900,000.
Common stockholders are entitled to receive dividends, as may be declared by the Company’s board of directors, if any, subject to the preferential dividend rights of the Preferred Stock. No dividends have been declared or paid during the years ended December 31, 2022 and 2021.
The Company has reserved the following shares of common stock for future issuance:
 
    
As of December 31,
 
    
2022
    
2021
 
Shares reserved upon the conversion of authorized Series A preferred stock
  
 
47,628,788
 
     47,628,788  
Shares reserved upon the conversion of authorized Series A1 preferred stock
  
 
6,500,000
 
     6,500,000  
Shares reserved upon the conversion of authorized Series B preferred stock
  
 
54,689,627
 
     54,689,627  
Shares reserved for future issuance under the 2017 Stock Incentive Plan
  
 
1,669,058
 
     691,090  
Shares reserved for stock option exercises
  
 
22,997,639
 
     16,877,957  
Shares reserved for warrants
  
 
166,371
 
     166,371  
  
 
 
    
 
 
 
  
 
133,651,483
 
     126,553,833  
  
 
 
    
 
 
 
11. Stock-Based Compensation
Grants under the 2017 Plan
The Company adopted the 2017 Stock Option and Grant Plan and subsequent amendments (the Plan) with 25,956,535 shares of common stock reserved for issuance to employees, directors, and consultants. The Plan allows for the grant of incentive stock options,
non-statutory
stock options, restricted stock awards, restricted stock unit awards and other stock awards. Recipients of stock options are eligible to purchase shares of the Company’s common stock at an exercise price equal to the estimated fair market value of such stock on the date of grant. The maximum contractual term of options granted under the Plan is ten years, and the awards vest under such terms prescribed by the Company’s board of directors.
Since inception, the Company has granted restricted stock awards,
non-qualified
stock options and incentive stock options. As of December 31, 2022, 1,669,058 shares remain available for future grant under the Plan.
 
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Restricted Stock
For the restricted stock awards, the purchase price equaled the estimated fair value of the common stock as determined by the board of directors on the date of grant. The Company has the right, but not the obligation to repurchase unvested shares at the original purchase price if employees or
non-employees
are terminated or cease their employment or service relationship with the Company. The vesting period is generally contingent upon continued employment or consulting services being provided to the Company. The shares typically vest over a
two-year
or four-year period. The unvested shares of restricted stock are not considered outstanding shares for accounting purposes until the shares vest.
The following table summarizes restricted stock activity:
 
    
Number of

Shares
    
Weighted

Average

Grant Date

Fair Value
 
Unvested as of December 31, 2021
     3,232      $ 0.0001  
Vested
     (3,232 )       0.0001  
  
 
 
    
 
 
 
Unvested as of December 31, 2022
     —        $ —    
  
 
 
    
 
 
 
The aggregate fair value of restricted stock awards that vested during the years ended December 31, 2022 was zero. No restricted stock awards were issued during the years ended December 31, 2022 and 2021. As of December 31, 2022, no shares remained subject to a repurchase right by the Company.
As of December 31, 2022, there was no unrecognized compensation cost related to the unvested restricted stock awards.
Stock Options
Stock options granted by the Company typically vest over a four-year period and have a
ten-year
contractual term. The following table summarizes the Company’s stock option activity under the 2017 Plan during the year ended December 31, 2022:
 
    
Number of
Shares
    
Weighted-
Average
Exercise
Price
    
Weighted-
Average
Remaining
Contractual
Term
(In Years)
    
Aggregate
Intrinsic
Value
(in
thousands)
 
Outstanding at December 31, 2021
     16,877,957      $ 0.32        8.85      $ 438  
Granted
     9,352,722        0.36        —       
Exercised
     (307,859 )       0.22        —       
Cancelled
     (2,925,181 )       0.34        —       
  
 
 
    
 
 
    
 
 
    
 
 
 
Outstanding at December 31, 2022
     22,997,639      $ 0.34        7.94      $ 362  
  
 
 
    
 
 
    
 
 
    
 
 
 
Exercisable at December 31, 2022
     8,635,922      $ 0.31        5.81      $ 315  
  
 
 
    
 
 
    
 
 
    
 
 
 
The weighted-average grant date fair value per share of options granted in the period ended December 31, 2022 was $0.26. The total fair value of options vested during 2022 was $1.2 million. As of December 31, 2022, total unrecognized compensation costs to the unvested stock options was approximately $3.5 million, which is expected to be recognized over a weighted-average period of 3.1 years.
 
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Stock-Based Compensation Expense
For purposes of calculating stock-based compensation, the Company estimates the fair value of stock options using the Black-Scholes option-pricing model. This model incorporates various assumptions, including the expected volatility, expected term, and interest rates.
The underlying assumptions used to value stock options granted using the Black-Scholes option-pricing model during the year ended December 31, 2022 were as follows:
 
    
Year Ended December 31,
 
    
2022
    
2021
 
Risk-free interest rate range
     1.74% – 3.90%        0.60% – 1.27%  
Expected dividend rate
     —          —    
Expected term (years) range
     5.94 – 6.11        5.94 – 6.11  
Expected stock price volatility range
     85.9% – 88.9%        83.9% – 86.4%  
Risk-Free Interest Rate –
The risk-free rate assumption is based on the U.S. Treasury instruments, the terms of which were consistent with the expected term of the Company’s stock options.
Expected Dividend –
The expected dividend assumption is based on the Company’s history and expectation of dividend payouts. The Company has not paid and does not intend to pay dividends.
Expected Term –
The expected term of stock options represents the weighted average period the stock options are expected to be outstanding. The Company uses the simplified method for estimating the expected term, which calculates the expected term as the average
time-to-vesting
and the contractual life of the options for stock options issued to employees. The expected term for options granted to
non-employees
is based on the contractual life of the options.
Expected Volatility –
Due to the Company’s limited operating history and lack of company-specific historical or implied volatility, the expected volatility assumption was determined by examining the historical volatilities of a group of industry peers whose share prices are publicly available. The Company expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded stock price.
Fair Value of Common Stock
– As there has been no public market for the Company’s common stock to date, the estimated fair value of its common stock has been determined by the Company using estimates and assumptions on the respective grant dates of the awards. These estimates and assumptions include a number of objective and subjective factors, including external market conditions, the prices at which the Company sold shares of preferred securities, the superior likelihood of, achieving a liquidity event, such as an IPO or sale. Significant changes to the key assumptions used in the valuations could result in different fair values of common stock at each valuation date.
Stock-Based Compensation Expense
The Company recorded stock-based compensation expense in the following expense categories of its statements of operations (in thousands):
 
    
Year Ended December 31,
 
    
        2022        
    
        2021        
 
Research and development
  
$
447
 
   $ 369  
General and administrative
  
 
791
 
     384  
  
 
 
    
 
 
 
Total stock-based compensation expense
  
$
1,238
 
   $ 753  
  
 
 
    
 
 
 
 
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12. Agreements with Horizon
The Company entered into a Collaboration and Option Agreement (the Horizon Collaboration Agreement) and an Asset Purchase Agreement (the Purchase Agreement, collectively with the Horizon Collaboration Agreement, the Horizon Agreements) with Horizon Therapeutics Ireland DAC (Horizon) on August 12, 2022. Prior to the execution of the Horizon Agreements, the Company had completed a Phase 1 study for bempikibart (formerly
ADX-914,
a fully humanized, high affinity
anti-inerleukin-7
receptor antagonist antibody) and was preparing to initiate two separate Phase 2 clinical trials. Under the terms of the Horizon Agreements, the Company is required to complete the two planned Phase 2 clinical trials as well as certain other development work agreed to by the parties. Horizon has the option to purchase bempikibart at any time up until the option termination date, which would have been shortly after the receipt of a data package from the second Phase 2 clinical trial. If Horizon elects to exercise the option to acquire bempikibart, Horizon would have received all tangible and
non-tangible
assets related to bempikibart, including the assignment of the license the Company obtained from BMS (see Note 7) when it initially acquired the technology, and would have assumed liabilities associated with bempikibart, including payment obligations under the BMS license.
Per the terms of the Horizon Collaboration Agreement, the Company received a total of $55.0 million for initiation of certain development activities associated with the planned clinical trials and related activities. If Horizon had exercised its option, the Company would have receive a prespecified fee, subject to certain adjustments, pursuant to the Purchase Agreement, subject to certain adjustments. The Company was also entitled to receive additional payment from Horizon based on the achievement of future development and regulatory milestones as well as royalty payments on annual net sales.
Accounting analysis
The Company concluded the arrangement was partially within the scope of Topic 606. Specifically, the Company concluded that the research services required to be performed as part of the Horizon Collaboration Arrangement represented an output of the Company’s ordinary activities, and this represents a contract with a customer. The Company concluded that the potential sale of bempikibart was not an output of the Company’s ordinary activities and therefore this component of the Agreements is considered to be a sale of an asset and not accounted for under Topic 606. At the commencement of the collaboration arrangement with Horizon, the Company identified two performance obligations related to the development activities of bempikibart, one of each of the specified clinical trials, with each composing the services related to the clinical trial and other related development activities. The Company also identified a material right related to the option for Horizon to purchase bempikibart. The material right was considered a separate performance obligation pursuant to the provisions of Topic 606. The Company determined the transaction price to be $55.0 million which it allocated to the three performance obligations based on the estimated stand-alone selling price of each performance obligation.
The following table summarizes the allocation of the transaction price allocated to each performance obligation (in thousands):
 
    
Transaction
Price
 
AD phase 2 research services
   $ 25,417  
AA phase 2 research services
     18,265  
Material right for the purchase of
ADX-914
     11,318  
  
 
 
 
Total
   $ 55,000  
  
 
 
 
The Company concluded that the consideration allocated to the research service performance obligations should be recognized over time as Horizon received the benefit of the research activities as the activities were performed. The Company has determined that this method was most appropriate as progress towards completion of research is largely driven by time and effort spent and costs incurred to perform this research. There are
 
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significant judgments and estimates inherent in the determination of the costs to be incurred for the research and development activities related to the collaboration with Horizon. These estimates and assumptions include a number of objective and subjective factors, including the potential third-party costs related to each of the Phase 2 clinical trials. Any changes to these estimates will be recognized in the period in which they change as a cumulative
catch-up.
As of December 31, 2022, the amounts of the allocated transaction price that are unsatisfied or partially satisfied for AD and AA phase 2 research services were $20.5 million and $16.5 million, respectively. The consideration allocated to the material right would have been included in the consideration associated with the sale of bempikibart when and if the option had been exercised by Horizon or would have been recognized upon expiration of the option.
As of December 31, 2022, the Company had received $32.5 million of the $55.0 million transaction price from Horizon. The Company recognized $6.7 million of collaboration agreement revenue for the year ended December 31, 2022. As of December 31, 2022, approximately $25.8 million remains in collaboration deferred revenue, of which $14.5 million is included in deferred revenue, current portion and $11.3 million is included in deferred revenue, net of current portion on the consolidated balance sheets, based on anticipating timing of recognition of the amounts.
13. Related Party Transactions
The Company has consulting and advisory agreements with certain investors and board members which are considered to be related party transactions. For the years ended December 31, 2022 and 2021, the Company recorded expense of $87 thousand and $60 thousand, respectively, related to services provided by these investors.
No amounts were due to related parties at December 31, 2022 or 2021.
14. Defined Contribution Plan
The Company has a defined contribution savings plan under Section 401(k) of the Internal Revenue Code (the 401(k) Plan). The 401(k) Plan covers all employees who meet defined minimum age and service requirements and allows participants the option to elect to defer a portion of their annual compensation on a pretax basis, as well as Roth post tax deferrals. As currently designed, the Company is not required to make and has not made any contributions to the 401(k) Plan.
15. Income Taxes
For the years ended December 31, 2022 and 2021, the Company recorded current and deferred income tax expense of $62 thousand and $0.6 million, respectively. The Company’s effective tax rate of 0.0% differs from the U.S. statutory tax rate of 21.0% primarily as a result of the valuation allowance maintained against the Company’s net deferred tax assets.
For financial reporting purposes, loss from operations before income taxes includes the following components (in thousands):
 
    
Year Ended
December 31,
 
    
2022
    
2021
 
Pretax loss:
     
United States
  
$
(42,722
) 
   $ (36,877 ) 
Foreign
  
 
(25
) 
     (40 ) 
  
 
 
    
 
 
 
Loss before income taxes
  
$
(42,747
) 
   $ (36,917 ) 
  
 
 
    
 
 
 
 
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The components of our provision for income taxes during the two years ended December 31, 2022, consisted of the following (in thousands):
 
    
Year Ended
December 31,
 
    
2022
    
2021
 
Current:
     
Federal
  
$
—  
 
   $ —    
State
  
 
—  
 
  
 
—  
 
Foreign
  
 
62
 
     547  
  
 
 
    
 
 
 
Total current
  
 
62
 
     547  
Deferred:
     
Federal
  
$
—  
 
   $ —    
State
  
 
—  
 
  
 
—  
 
Foreign
  
 
—  
 
  
 
—  
 
  
 
 
    
 
 
 
Total deferred
  
 
—  
 
  
 
—  
 
  
 
 
    
 
 
 
Total income tax provision
  
$
62
 
   $ 547  
  
 
 
    
 
 
 
A reconciliation of income tax expense (benefit) computed at the statutory federal income tax rate to income taxes as reflected in the financial statements is as follows:
 
    
Y
ear Ended
December 31,
 
    
2022
   
2021
 
Federal income tax expense at statutory rate
     21.0 %      21.0 % 
State income taxes, net of federal benefit
     6.9       6.9  
Permanent differences
     (0.4 )      (1.1 ) 
Foreign rate differential
     0.0       (0.2 ) 
Research and development tax credits
     4.1       4.0  
Change in valuation allowance
     (31.6 )      (30.6 ) 
  
 
 
   
 
 
 
Effective income tax rate
     —   %      —   % 
  
 
 
   
 
 
 
 
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Deferred taxes are recognized for temporary differences between the basis of assets and liabilities for financial statement and income tax purposes. The significant components of the Company’s deferred tax assets and liabilities consisted of the following (in thousands):
 
    
2022
    
2021
 
Deferred tax assets:
     
Federal net operating loss carryforwards
  
$
19,135
 
   $ 15,792  
State net operating loss carryforwards
  
 
5,401
 
     4,603  
Foreign net operating loss carryforwards
  
 
—  
 
     —    
Capitalized intangible assets
  
 
3,089
 
     3,360  
Tax credit carryforwards
  
 
4,745
 
     2,536  
Capitalized R&D expenditures
  
 
7,378
 
     —    
Lease liability
  
 
1,962
 
     —    
Stock compensation and other
  
 
977
 
     554  
  
 
 
    
 
 
 
Net deferred tax assets before valuation allowance
  
 
42,687
 
     26,845  
Deferred tax asset valuation allowance
  
 
(40,342
) 
     (26,740 ) 
  
 
 
    
 
 
 
Net deferred tax assets
  
 
2,345
 
     105  
  
 
 
    
 
 
 
Deferred tax liabilities:
     
Fixed assets
  
$
(483
) 
   $ (105 ) 
Right of use asset
  
 
(1,862
) 
     (105 ) 
  
 
 
    
 
 
 
Net deferred tax assets
  
$
—  
 
   $ —    
  
 
 
    
 
 
 
The Company had net deferred tax assets before valuation allowances of $42.7 million and $26.8 million as of December 31, 2022 and 2021, respectively, primarily attributable to net operating losses. The Company has provided a valuation allowance for the full amount of the net deferred tax assets as, based on all available evidence, it is considered more likely than not that all the recorded deferred tax assets will not be realized in a future period. The valuation allowance in 2022 increased due to the increase in the deferred tax assets by the same amount (primarily due to the increase in the net operating loss carryforwards).
As of December 31, 2022, the Company has $91.1 million of federal net operating loss carryforwards, of which $1.0 million will begin to expire in 2037 and $90.1 million can be carried forward indefinitely, and $85.5 million of state net operating loss carryforwards that expire at various dates beginning in 2037.
Subject to the limitations described below, as of December 31, 2022, the Company had federal and state research and development tax credit carryforwards of $3.6 million and $1.4 million, respectively available to reduce future tax liabilities which start to expire in 2038. The Company has generated federal and state research and development credits but has not conducted a study to document the qualified activity. This study may result in an adjustment to the Company’s research and development credit carryforwards; however, until a study is completed, and any adjustment is known, no amounts are being presented as uncertain tax position. A full valuation allowance has been provided against the Company’s research and development credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the deferred tax asset established for the research and development credit carryforwards and the valuation allowance.
Realization of the future tax benefits is dependent on many factors, including the Company’s ability to generate taxable income within the net operating loss carryforward period. Under the provisions of the Internal Revenue Code, the net operating loss and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service (IRS) and state tax authorities. Net operating loss and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code, respectively, as well as similar state provisions. This could limit the amount of tax attributes
 
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that can be utilized annually to offset future taxable income or tax liabilities. The amount of the annual limitation is determined based on the value of the Company immediately prior to the ownership change. As a result of ownership changes in the Company from its inception through December 31, 2022, the Company’s NOL and tax credit carryforwards allocable to the periods preceding each such ownership change could be subject to limitations under IRC Section 382, however the Company has not yet completed an IRC Section 382 study.
The Company files income tax returns in the United States, Australia and Massachusetts. The statute of limitations for assessment by the IRS and state tax authorities is closed prior to 2018, although carryforward attributes that were generated prior to tax year 2018 may still be adjusted upon examination by the IRS or state tax authorities if they either have been or will be used in a future period. The Company is currently not under examination by the IRS or any other jurisdictions for any tax years. The statute of limitations for assessment by the Australian Taxation Office is four years from the date of return filing. The Company is not currently under examination by the Australian Taxation Office for any tax years.
The Company’s current intention is to permanently reinvest the total amount of its unremitted earnings in the local international jurisdiction. As such, the Company has not provided for taxes on the unremitted earnings of its international subsidiary. As of December 31, 2022, the Company’s foreign subsidiary does not have any unremitted foreign earnings.
The Company establishes reserves for uncertain tax positions based on management’s assessment of exposures associated with tax positions taken on tax return filings. The tax reserves are analyzed periodically, and adjustments are made as events occur to warrant adjustments to the reserve.
As of December 31, 2022, the Company had no gross unrecognized tax benefits. During 2022 the Company amended its prior year tax filings and settled the $1.4 million unrecognized tax benefit that was previously recognized in the December 31, 2021 reporting period. The company does not expect the unrecognized tax benefits to change significantly over the next 12 months. The company recognizes both interest and penalties associated with uncertain tax positions as a component of income tax expense. As of December 31, 2022, the Company has not accrued penalties and provisions for interest.
16. Net Loss per Share
Basic and diluted loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average common shares outstanding.
The Company’s potentially dilutive securities, which include convertible preferred stock, convertible notes, unvested restricted common stock, and stock options, have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The Company excluded the following from the computation of diluted net loss per share attributable to common stockholders because including them would have had an anti-dilutive effect:
 
    
Year Ended
December 31,
 
    
2022
    
2021
 
Series A convertible preferred stock
     47,628,788        47,628,788  
Series
A-1
convertible preferred stock
     6,500,000        6,500,000  
Series B convertible preferred stock:
     54,689,627        54,689,627  
Unvested restricted common stock
     —          3,232  
Options to purchase common stock
     22,997,639        16,877,957  
Warrants to purchase common stock
     166,371        166,371  
 
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In addition, during the year ended December 31, 2022, the Company issued convertible notes with a principal balance of $30.0 million. These convertible notes and any accrued interest may convert into either a variable number of common shares or into shares of Series B Preferred Stock based on a fixed exchange ratio. Any shares of Series B Preferred Stock issued to settle the convertible notes would then be convertible into shares of common stock.    
17. Subsequent Events
The Company considers events or transactions that occur after the balance sheet date but prior to the date the financial statements are available to be issued for potential recognition or disclosure in the financial statements. The Company has completed an evaluation of all subsequent events after the audited balance sheet date of December 31, 2022 through December 15, 2023, the date the financial statements were issued, to ensure that these financial statements include appropriate disclosure of events both recognized in the financial statements as of December 31, 2022 and events which occurred subsequently but were not recognized in the financial statements.
Amendment to Loan Agreement
On April 26, 2023 and July 12, 2023, the Company executed a fifth and sixth amendments to the Loan Agreement. See Note 8 for details on the Loan Agreement and amendments.
On November 2, 2023, a seventh amendment to the Loan Agreement was entered into with the lender. The additional loan advance of $7.0 million, the first advance stated in the sixth amendment to the Loan Agreement, could be drawn down once the company received net proceeds of $75.0 million. The seventh amendment extends the time the Company has to receive the net proceeds to March 31, 2024 and provides that $37.5 million of the total $75 million requirement must be through the issuance and sale of equity securities.
Amendment to Convertible Notes
On April 27, 2023, the Company amended the maturity dates for the Convertible Notes. See Note 8 for details.
Rights to Bempikibart (formerly
ADX-914)
As more fully discussed in Note 12 on August 12, 2022, the Company entered into the Horizon Agreements. Under the terms of the Horizon Agreements, the Company received an initial consideration and development funding under the bempikibart program totaling $55.0 million, which funded two ongoing Phase 2 trials for bempikibart. Horizon had an option to acquire the program at a prespecified price, subject to certain adjustments. In October 2023, Amgen Inc. (Amgen) completed its acquisition of Horizon Therapeutics public limited company (Horizon plc). Following the closing of Amgen’s acquisition of Horizon plc, the Company agreed with Amgen to mutually terminate the Horizon Agreements and in November 2023, the Company and Horizon entered into a termination agreement (the Horizon Termination Agreement), pursuant to which Horizon’s option to acquire the bempikibart program was terminated. As a result, the Company retained all initial consideration and development funding received under the Horizon Collaboration Agreement and regained full development and commercial rights to bempikibart. In consideration for the Horizon Termination Agreement, the Company agreed to pay Horizon regulatory and sales milestones payments of up to an aggregate amount of $75.1 million upon the first achievement of certain regulatory and sales milestones with respect to bempikibart.
Proposed Merger with Homology
On November 16, 2023, the Company entered into an Agreement and Plan of Merger and Reorganization (the Merger Agreement) with Homology and Kenobi Merger Sub, Inc., a wholly owned subsidiary of Homology (Merger Sub). Pursuant to the Merger Agreement and subject to the satisfaction or waiver of the conditions
 
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therein, Merger Sub will merge with and into the Company, with the Company continuing as the surviving company and as a wholly owned subsidiary of Homology (the Merger). If the Merger is completed, the business of the Company will continue as the business of the combined company. The Merger is intended to qualify for federal income tax purposes as a
tax-free
reorganization under the provisions of Section 368(a) of the Internal Revenue Code of 1986, as amended.
The Merger is expected to close in the first quarter of 2024 and is subject to approval by the stockholders of the Company and Homology as well as other customary closing conditions, including the effectiveness of a registration statement filed with the SEC in connection with the transaction. If Homology is unable to satisfy certain closing conditions or if other mutual closing conditions are not satisfied, the Company will not be obligated to complete the Merger. The Merger Agreement contains certain termination rights of each of the Company and Homology. Under certain circumstances, the Company could be required to pay Homology a termination fee of $5.85 million. Homology could be required to pay the Company a termination fee of $2.4 million.
Subject to the terms and conditions of the Merger Agreement, at the effective time of the Merger (the Effective Time), each then outstanding share of the Company’s common stock (including shares of common stock issued upon conversion of the Company’s preferred stock, shares of the Company’s common stock issued upon conversion of Q32’s convertible notes and shares of the Company’s common stock issued in the Q32
pre-closing
financing defined below) will be converted into the right to receive a number of shares of Homology’s common stock calculated in accordance with the Merger Agreement (the exchange ratio).
In connection with the Merger Agreement, certain third parties have entered into a subscription agreement with the Company to purchase shares of the Company’s common stock for an aggregate purchase price of approximately $42.0 million (the Q32
Pre-Closing
Financing). The Q32
Pre-Closing
Financing is contingent on and will occur prior to the closing of the Merger, subject to customary closing conditions. Shares of the Company’s common stock issued pursuant to the Q32
Pre-Closing
Financing will be converted into shares of Homology common stock in accordance with the exchange ratio at the Effective Time.
Each share of Homology common stock that is issued and outstanding at the Effective Time will remain issued and outstanding and such shares, subject to the Reverse Stock Split, will be unaffected by the Merger.
At the Effective Time, each person who as of immediately prior to the Effective Time was a stockholder of record of Homology or had the right to receive Homology’s common stock will be entitled to receive a contractual contingent value right (CVR) issued by Homology subject to and in accordance with the terms and conditions of a Contingent Value Rights Agreement between Homology and the rights agent (the “CVR Agreement”), representing the contractual right to receive cash payments from the combined company upon the receipt of certain proceeds from a disposition of Homology’s
pre-merger
assets, calculated in accordance with the CVR Agreement.
Although the Company intends to consummate the merger, there is no assurance that it will be successful.
Amendment to Certificate of Incorporation
On November 16, 2023, the Company amended its Second Amended and Restated Certificate of Incorporation to increase the number of its authorized common stock by 83,100,000 shares from 141,900,000 shares to 225,000,000 shares.
Stock Option Grants
In November 2023, the Company granted under the 2017 Stock Option Plan, 1,123,354, stock options to five individuals, which included new employees, executives and one consultant. Stock options were issued with an exercise price of $0.82 per share. The stock option awards vest in accordance with terms typically granted under the 2017 Stock Option Plan.
 
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Q32 BIO INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except share and per share data)
(Unaudited)
 
    
September 30,
2023
   
December 31,
2022
 
Assets
    
Current assets:
    
Cash and cash equivalents
  
$
36,256
 
  $ 43,893  
Prepaid expenses and other current assets
  
 
2,845
 
    2,960  
  
 
 
   
 
 
 
Total current assets
  
 
39,101
 
    46,853  
Property and equipment, net
  
 
1,906
 
    2,276  
Right-of-use
asset, operating leases
  
 
6,438
 
    6,890  
Restricted cash and restricted cash equivalents
  
 
5,647
 
    5,647  
Other
non-current
assets
  
 
677
 
    108  
  
 
 
   
 
 
 
Total assets
  
$
53,769
 
  $ 61,774  
  
 
 
   
 
 
 
Liabilities, convertible preferred stock and stockholders’ deficit
    
Current liabilities:
    
Accounts payable
  
$
1,829
 
  $ 1,435  
Accrued expenses and other current liabilities
  
 
7,399
 
    9,497  
Convertible notes
  
 
37,394
 
    32,402  
Venture debt
  
 
418
 
    —    
Deferred Revenue, current portion
  
 
24,798
 
    14,531  
  
 
 
   
 
 
 
Total current liabilities
  
 
71,838
 
    57,865  
Deferred revenue, net of current portion
  
 
15,540
 
    11,318  
Lease liability, net of current portion
  
 
6,386
 
    6,786  
Venture debt, net of current portion
  
 
5,011
 
    5,072  
  
 
 
   
 
 
 
Total liabilities
  
 
98,775
 
    81,041  
Commitments and contingencies (Note 7)
    
Series A convertible preferred stock, $0.0001 par value, 47,628,788 shares authorized, issued and outstanding at September 30, 2023 and December 31, 2022 (liquidation preference of $47,629 at September 30, 2023)
  
 
47,458
 
    47,458  
Series
A-1
convertible preferred stock, $0.0001 par value, 6,500,000 shares authorized, issued and outstanding at September 30, 2023 and December 31, 2022 (liquidation preference of $5,753 as of September 30, 2023)
  
 
4,132
 
    4,132  
Series B convertible preferred stock, $0.0001 par value, 54,689,627 shares authorized, issued and outstanding at September 30, 2023 and December 31, 2022 (liquidation preference of $60,000 as of September 30, 2023)
  
 
59,855
 
    59,855  
  
 
 
   
 
 
 
Total convertible preferred stock
  
 
111,445
 
    111,445  
Stockholders’ deficit:
    
Common stock, $0.0001 par value; 141,900,000 and 141,900,000 shares authorized, 7,258,304 and 7,139,216 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively
  
 
1
 
    1  
Additional
paid-in
capital
  
 
3,562
 
    2,625  
Accumulated deficit
  
 
(160,014
) 
    (133,338 ) 
  
 
 
   
 
 
 
Total stockholders’ deficit
  
 
(156,451
) 
    (130,712 ) 
  
 
 
   
 
 
 
Total liabilities, convertible preferred stock and stockholders’ deficit
  
$
53,769
 
  $ 61,774  
  
 
 
   
 
 
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
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Q32 BIO INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(amounts in thousands, except share and per share data)
(Unaudited)
 
    
Nine Months Ended September 30,
 
    
          2023          
   
          2022          
 
Collaboration arrangement revenue
  
$
8,011
 
  $ 2,871  
Operating expenses:
    
Research and development
  
 
23,390
 
    26,624  
General and administrative
  
 
7,067
 
    7,561  
  
 
 
   
 
 
 
Total operating expenses
  
 
30,457
 
    34,185  
  
 
 
   
 
 
 
Loss from operations
  
 
(22,446
) 
    (31,314 ) 
  
 
 
   
 
 
 
Change in fair value of convertible notes
  
 
(4,992
) 
    (997 ) 
Other income (expense), net
  
 
827
 
    (765 ) 
  
 
 
   
 
 
 
Total other income (expense), net
  
 
(4,165
) 
    (1,762 ) 
  
 
 
   
 
 
 
Loss before provision for income taxes
  
 
(26,611
) 
    (33,076 ) 
Provision for income taxes
  
 
(65
) 
    (45 ) 
  
 
 
   
 
 
 
Net loss and comprehensive loss
  
$
(26,676
) 
  $ (33,121 ) 
  
 
 
   
 
 
 
Net loss attributable to common stockholders—basic and diluted
  
$
(26,676
) 
  $ (33,121 ) 
  
 
 
   
 
 
 
Weighted-average common shares—basic and diluted
  
 
  7,217,158
 
      6,987,071  
  
 
 
   
 
 
 
Net loss per share attributable to common stockholders—basic and diluted
  
$
(3.70
) 
  $ (4.74 ) 
  
 
 
   
 
 
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
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Q32 BIO INC.
CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT
(amounts in thousands, except share data)
(Unaudited)
 
   
Series A
Convertible
Preferred Stock
   
Series
A-1

Convertible
Preferred Stock
   
Series B
Convertible
Preferred Stock
   
Common Stock
   
Additional
Paid

in Capital
   
Accumulated

Deficit
   
Total
Stockholders’

Deficit
 
   
Shares
   
Amount
   
Shares
   
Amount
   
Shares
   
Amount
   
Shares
   
Amount
 
Balance as of December 31, 2021
    47,628,788     $ 47,458       6,500,000     $ 4,132       54,689,627     $ 59,855       6,828,125     $ 1     $ 1,318     $ (90,529 )    $ (89,210 ) 
Exercise of stock options
    —         —         —         —         —         —         307,859       —         69       —         69  
Vesting of restricted stock
    —         —         —         —         —         —         3,232       —         —         —         —    
Stock-based compensation expense
    —         —         —         —         —         —         —         —         920       —         920  
Net loss
    —         —         —         —         —         —         —         —         —         (33,121 )      (33,121 ) 
 
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Balance as of September 30, 2022
    47,628,788       47,458       6,500,000       4,132       54,689,627       59,855       7,139,216       1       2,307       (123,650 )      (121,342 ) 
Balance as of December 31, 2022
    47,628,788       47,458       6,500,000       4,132       54,689,627       59,855       7,139,216       1       2,625       (133,338 )      (130,712 ) 
Exercise of stock options
    —         —         —         —         —         —      
 
119,088
 
 
 
—  
 
 
 
31
 
 
 
—  
 
 
 
31
 
Stock-based compensation expense
    —         —         —         —         —         —      
 
—  
 
 
 
—  
 
 
 
906
 
 
 
—  
 
 
 
906
 
Net loss
    —         —         —         —         —         —      
 
—  
 
 
 
—  
 
 
 
—  
 
 
 
(26,676
) 
 
 
(26,676
) 
 
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Balance as of September 30, 2023
 
 
47,628,788
 
 
$
47,458
 
 
 
6,500,000
 
 
$
4,132
 
 
 
54,689,627
 
 
$
59,855
 
 
 
7,258,304
 
 
$
1
 
 
$
3,562
 
 
$
(160,014
) 
 
$
(156,451
) 
 
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
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Q32 BIO INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(amounts in thousands)
(Unaudited)
 
    
Nine Months Ended
September 30,
 
    
2023
   
2022
 
Cash flows from operating activities:
    
Net loss
  
$
(26,676
) 
  $ (33,121 ) 
Adjustments to reconcile net loss to net cash used in operating activities:
    
Amortization of debt discount and issuance costs
  
 
57
 
    75  
Depreciation expense
  
 
375
 
    242  
Stock-based compensation expense
  
 
906
 
    920  
Non-cash
lease expense
  
 
405
 
    643  
Changes in fair value of convertible notes
  
 
4,992
 
    997  
Changes in operating assets and liabilities:
    
Prepaid expenses and other current assets
  
 
162
 
    (1,625 ) 
Other
non-current
assets
  
 
(569
) 
    264  
Accounts payable
  
 
394
 
    (1,627 ) 
Operating lease liability
  
 
(350
) 
    (304 ) 
Accrued expenses and other current liabilities
  
 
(2,148
) 
    930  
Deferred revenue
  
 
14,489
 
    12,129  
  
 
 
   
 
 
 
Net cash used in operating activities
  
 
(7,963
) 
    (20,477 ) 
Cash flows from investing activities:
    
Purchases of property and equipment
  
 
(5
) 
    (2,485 ) 
  
 
 
   
 
 
 
Net cash used in investing activities
  
 
(5
) 
    (2,485 ) 
Cash flows from financing activities:
    
Proceeds from issuance of convertible notes, net of issuance costs
  
 
—  
 
    13,333  
Proceeds from borrowings under loan and security agreement, net
  
 
5,500
 
    —    
Payments on borrowings under loan and security agreement, net
  
 
(5,200
) 
    —    
Proceeds from exercise of common stock options
  
 
31
 
    69  
  
 
 
   
 
 
 
Net cash provided by financing activities
  
 
331
 
    13,402  
  
 
 
   
 
 
 
Net increase (decrease) in cash, cash equivalents, restricted cash and restricted cash equivalents
  
 
(7,637
) 
    (9,560 ) 
Cash, cash equivalents, restricted cash and restricted cash equivalents at beginning of period
  
 
49,540
 
    32,894  
  
 
 
   
 
 
 
Cash, cash equivalents, restricted cash and restricted cash equivalents at end of period
  
$
41,903
 
  $ 23,334  
  
 
 
   
 
 
 
Supplemental disclosure of
non-cash
operating, investing and financing activities:
    
Right-of-use
asset obtained in exchange for new operating lease liability
  
$
—  
 
  $ 7,666  
The accompanying notes are an integral part of these consolidated financial statements.
 
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Q32 BIO INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Nature of the Business
Q32 Bio Inc. (Q32 or the Company) was formed on April 10, 2017 as Admirx, Inc. under the laws of the state of Delaware and is headquartered in Waltham, Massachusetts. On March 20, 2020, the Company changed its name to Q32 Bio Inc. The Company aims to bring safer, more efficacious therapeutics to patients suffering from a wide range of devastating autoimmune and inflammatory diseases, starting with those rooted in the complement system and
interleukin-7
(IL-7)
signaling pathways.
Since its inception, the Company’s operations have been focused on organizing and staffing, business planning, raising capital, establishing the Company’s intellectual property portfolio and performing research and development of its product candidates, programs and platform. The Company has primarily funded its operations with proceeds from the sale of convertible preferred stock, convertible notes, venture debt and a collaboration arrangement.
Risks and Uncertainties
The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including but not limited to, risks associated with completing preclinical studies and clinical trials, obtaining regulatory approvals for product candidates, development by competitors of new biopharmaceutical products, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Programs currently under development will require significant additional research and development efforts, including preclinical and clinical testing and will need to obtain regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from product sales.
Liquidity and Going Concern
As of September 30, 2023, the Company had cash and cash equivalents of $36.3 million and an accumulated deficit of $159.9 million. The Company had a net working capital deficiency of $32.7 million and $11.0 million, a net loss of $26.6 million and $42.8 million for the nine months ended September 30, 2023 and the year ended December 31, 2022, respectively. The Company has funded its net losses principally through the sale of preferred stock, convertible notes, debt, and proceeds from a collaboration arrangement. The Company expects to experience negative cash flows from operations, and net losses for the foreseeable future as it continues to invest significantly in research and development of its product candidates and platform.
All of the Company’s products are in development. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapid change in technology and substantial competition. In addition, the Company is dependent upon the services of its employees and consultants.
The Company expects its existing cash and cash equivalents will not be sufficient to allow the Company to fund its operating expenses and capital expenditures requirements through at least the next twelve months from the issuance of these condensed consolidated financial statements.
 
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As a result, the Company will need substantial additional funding to support its continued operations and growth strategy. Until such a time as the Company can generate significant revenue from product sales, if ever, the Company expects to finance its operations through the sale of equity, debt financings or other capital sources, including collaborations with other companies or other strategic transactions. The Company may be unable to raise additional funds or enter into such other agreements on terms acceptable to the Company, or at all. If the Company fails to raise capital or enter into such agreements, needed, the Company may have to significantly delay, scale back or discontinue the development and commercialization of one or more of its product candidates or delay its pursuit of potential
in-licenses
or acquisitions. The Company is seeking to complete a transaction with Homology Medicines, Inc. (Homology) as well as complete a concurrent private placement to raise additional capital. However, there can be no assurances that such transactions will be completed.
Based on its recurring losses from operations incurred since inception, the expectation of continuing operating losses for the foreseeable future, and the need to raise additional capital to finance its future operations, the Company has concluded that there is substantial doubt about its ability to continue as a going concern within one year after the date that these consolidated financial statements are issued.
The accompanying consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties described above. Accordingly, the consolidated financial statements have been prepared on a basis that assumes the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.
Proposed Merger with Homology
On November 16, 2023, the Company entered into an Agreement and Plan of Merger (the Merger Agreement) with Homology, and Kenobi Merger Sub, Inc., a wholly owned subsidiary of Homology (Merger Sub). Pursuant to the Merger Agreement and subject to the satisfaction or waiver of the conditions therein, Merger Sub will merge with and into the Company, with the Company continuing as the surviving company and as a wholly owned subsidiary of Homology (the Merger). If the Merger is completed, the business of the Company will continue as the business of the combined company. The Merger is intended to qualify for federal income tax purposes as a
tax-free
reorganization under the provisions of Section 368(a) of the Internal Revenue Code of 1986, as amended.
The Merger is expected to close in the first quarter of 2024 and is subject to approval by the stockholders of the Company and Homology as well as other customary closing conditions, including the effectiveness of a registration statement filed with the SEC in connection with the transaction. If Homology is unable to satisfy certain closing conditions or if other mutual closing conditions are not satisfied, the Company will not be obligated to complete the Merger. The Merger Agreement contains certain termination rights of each of the Company and Homology. Under certain circumstances, the Company could be required to pay Homology a termination fee of $5.85 million. Homology could be required to pay the Company a termination fee of $2.4 million.
Subject to the terms and conditions of the Merger Agreement, at the effective time of the Merger (the Effective Time), each then outstanding share of the Company’s common stock (including shares of common stock issued upon conversion of the Company’s preferred stock, shares of Q32’s common stock issued upon conversion of Q32’s convertible notes and shares of the Company’s common stock issued in the Q32
pre-closing
financing defined below) will be converted into the right to receive a number of shares of Homology’s common stock calculated in accordance with the Merger Agreement (the “exchange ratio”).
In connection with the Merger Agreement, certain third parties have entered into a subscription agreement with the Company to purchase shares of the Company’s common stock for an aggregate purchase price of approximately $42.0 million (the Q32
Pre-Closing
Financing). The Q32
Pre-Closing
Financing is contingent on and will occur prior to the closing of the Merger, subject to customary closing conditions. Shares of the Company’s common stock issued pursuant to the Q32
pre-closing
financing will be converted into shares of Homology common stock in accordance with the exchange ratio at the Effective Time.
 
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Each share of Homology common stock that is issued and outstanding at the Effective Time will remain issued and outstanding and such shares, subject to the Reverse Stock Split, will be unaffected by the Merger
At the Effective Time, each person who as of immediately prior to the Effective Time was a stockholder of record of Homology or had the right to receive Homology’s common stock will be entitled to receive a contractual contingent value right (CVR) issued by Homology subject to and in accordance with the terms and conditions of a Contingent Value Rights Agreement between Homology and the rights agent (the CVR Agreement), representing the contractual right to receive cash payments from the combined company upon the receipt of certain proceeds from a disposition of Homology’s
pre-merger
assets, calculated in accordance with the CVR Agreement.
Although the Company intends to consummate the Merger, there is no assurance that it will be successful.
2. Summary of Significant Accounting Policies
Basis of Presentation
The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (GAAP). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Update (ASU) of the Financial Accounting Standards Board (FASB).
Principles of Consolidation
The accompanying consolidated financial statements include those of the Company and its
wholly-owned
subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
Unaudited Interim Condensed Consolidated Financial Information
The accompanying condensed consolidated financial statements as of September 30, 2023 and for the nine months ended September 30, 2023 and 2022 are unaudited. The financial data and other information contained in the notes hereto as of September 30, 2023 and for the nine months ended September 30, 2023 and 2022 are also unaudited. The condensed consolidated balance sheet data as of December 31, 2022 was derived from the Company’s audited consolidated financial statements included.
The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited annual consolidated financial statements, and in the opinion of management, reflect all adjustments, which include only normal recurring adjustments necessary for the fair presentation of the Company’s financial position as of September 30, 2023 and the results of its operations and cash flows for the nine months ended September 30, 2023 and 2022. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements as of and for the year ended December 31, 2022, and the notes thereto.
The results for the nine months ended September 30, 2023 are not necessarily indicative of results to be expected for the year ended December 31, 2023, or any other interim periods, or any future year or period.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. Actual results could materially differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the
 
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preparation of these consolidated financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, the valuation of common stock awards, the valuation of convertible notes, the accruals of research and development expenses, the identification of material rights and estimation of standalone selling price for the identified performance obligations in the collaboration agreement and the inputs and assumptions to the over-time recognition of revenue under the collaboration agreement. Estimates are periodically reviewed considering changes in circumstances, facts and historical experience. Actual results may differ from the Company’s estimates.
Concentrations of Credit Risk and Significant Suppliers
Financial instruments that potentially expose the Company to credit risk primarily consist of cash, cash equivalents, restricted cash and restricted cash equivalents. The Company maintains its cash, cash equivalents, restricted cash and restricted cash equivalents balances with accredited financial institutions and, consequently, the Company does not believe it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships.
The Company’s cash management limits investment to investment-grade securities with the objective to preserve capital and to maintain liquidity until the funds can be used in business operations. The Company maintains its cash in bank deposit accounts that are Federal Deposit Insurance Corporation (FDIC) insured up to $250,000. At times, the Company’s bank accounts may exceed the federal insurance limit.
The Company is dependent on contract development and manufacturing organizations (CDMOs) to supply products for research and development activities in its programs. In particular, the Company relies and expects to continue to rely on a small number of manufacturers to supply it with its requirements for the active pharmaceutical ingredients, other raw materials and formulated drugs related to these programs. These programs could be adversely affected by a significant interruption in the supply of active pharmaceutical ingredients, other raw materials and formulated drugs. The Company is also dependent on contract research organizations (CROs) which provide services related to the research and development activities in its programs.
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents
The Company considers all highly liquid investments that are readily convertible into cash with maturities of three months or less at the date of purchase to be cash equivalents. Cash equivalents are comprised of money market accounts invested in U.S. Treasury securities.
Restricted cash and restricted cash equivalents are comprised of deposits held by financial institutions used to collateralize letters of credit related to the Company’s lease arrangements and the Company’s venture debt.
The company includes the restricted cash and restricted cash equivalents balance in cash and cash equivalents when reconciling
beginning-of-period
and
end-of-period
total amounts shown on the consolidated statements of cash flows.
 
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Cash, cash equivalents, restricted cash and restricted cash equivalents consisted of the following (in thousands):
 
    
September 30,
2023
    
December 31,
2022
 
Cash and cash equivalents
  
$
36,256
 
   $ 43,893  
Restricted cash and cash equivalents
  
 
5,647
 
     5,647  
  
 
 
    
 
 
 
Total cash, cash equivalents, restricted cash and restricted cash equivalents
  
$
41,903
 
   $ 49,540  
  
 
 
    
 
 
 
Deferred Transaction Costs
The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with
in-process
equity financings as deferred transaction costs until such financings are consummated. After consummation of an equity financing, these costs are recorded as a reduction of the proceeds from the transaction, either as a reduction of the carrying value of the preferred stock or in stockholders’ deficit as a reduction of additional
paid-in
capital generated as a result of the transaction. Should the
in-process
equity financing be abandoned, the deferred transaction costs would be expensed immediately as a charge to operating expenses in the condensed consolidated statements of operations and comprehensive loss. During the nine months ended September 30, 2023, the Company has $0.6 million in deferred transactions costs related to the Merger.
Fair Value Measurements
Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the hierarchy, of which the first two are considered observable and the last is considered unobservable:
Level
 1 –
Quoted prices in active markets for identical assets or liabilities.
Level
 2 –
Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
Level
 3 –
Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
The carrying values of the Company’s cash, cash equivalents, restricted cash, restricted cash equivalents, prepaid expenses, and other current assets, accounts payable, and accrued expenses approximate their fair value due to their short-term nature. The carrying value of the Company’s term loan as of September 30, 2023 (see Note 8) approximated fair value based on interest rates currently available to the Company. During the year 2023, the Company’s convertible notes are carried at fair value determined in accordance with the fair value hierarchy (see Note 8).
Subsequent Event Considerations
The Company considers events or transactions that occur after the balance sheet date but prior to the issuance of the financial statements to provide additional evidence for certain estimates or to identify matters that require additional disclosure. Subsequent events have been evaluated as required.
 
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Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.
In June 2016, the FASB issued ASU
No. 2016-13,
Financial Instruments – Credit Losses (Topic 326) – Measurement of Credit Losses on Financial Instruments,
which has been subsequently amended by ASU
No. 2018-19,
ASU
No. 2019-04,
ASU
No. 2019-05,
ASU
No. 2019-10,
ASU
No. 2019-11
and ASU
No. 2020-03
(ASU
2016-13).
The provisions of ASU
2016-13
modify the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology and require a consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The Company adopted the standard on January 1, 2023. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements.
3. Fair Value Measurements
The carrying values of the Company’s prepaid expenses, and other current assets, accounts payable, and accrued expenses and other current liabilities approximate their fair value due to their short-term nature. The carrying value of the Company’s term loan as of September 30, 2023 (see Note 8) approximated fair value based on interest rates currently available to the Company.
The table below presents information about the Company’s assets and liabilities that are regularly measured and carried at fair value on a recurring basis at September 30, 2023 and December 31, 2022 and indicate the level within the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value, which is described further within Note 2, Summary of Significant Accounting Policies.
Financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2023 are summarized as follows (in thousands):
 
Description
  
Balance as of
September 30,
2023
    
Quoted
Prices in
Active
Markets
(Level 1)
    
Significant
Other
Observable
Inputs
(Level 2)
    
Significant
Other
Unobservable
Inputs
(Level 3)
 
Assets
           
Cash equivalents:
           
Money market funds
  
$
34,724
 
  
$
34,724
 
  
$
—  
 
  
$
—  
 
  
 
 
    
 
 
    
 
 
    
 
 
 
Restricted cash equivalents:
           
Money market funds
  
$
5,000
 
  
$
5,000
 
     
  
 
 
    
 
 
    
 
 
    
 
 
 
Total
  
$
39,724
 
  
$
39,724
 
  
$
—  
 
  
$
—  
 
  
 
 
    
 
 
    
 
 
    
 
 
 
Liabilities
           
Convertible Notes
  
$
37,394
 
  
$
—  
 
  
$
—  
 
  
$
37,394
 
  
 
 
    
 
 
    
 
 
    
 
 
 
Total
  
$
37,394
 
  
$
—  
 
  
$
—  
 
  
$
37,394
 
  
 
 
    
 
 
    
 
 
    
 
 
 
 
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Financial assets and liabilities measured at fair value on a recurring basis as of December 31, 2022 are summarized as follows (in thousands):
 
Description
  
Balance as of
December 31,
2022
    
Quoted
Prices in
Active
Markets
(Level 1)
    
Significant
Other
Observable
Inputs
(Level 2)
    
Significant
Other
Unobservable
Inputs
(Level 3)
 
Assets
           
Cash equivalents:
           
Money market funds
   $ 42,496      $ 42,496      $ —        $ —    
  
 
 
    
 
 
    
 
 
    
 
 
 
Restricted cash equivalents
           
Money market funds
   $ 5,000      $ 5,000      $ —        $ —    
  
 
 
    
 
 
    
 
 
    
 
 
 
Total
   $ 47,496      $ 47,496      $ —        $ —    
  
 
 
    
 
 
    
 
 
    
 
 
 
Liabilities
           
Convertible Notes
   $ 32,402      $ —        $ —        $ 32,402  
  
 
 
    
 
 
    
 
 
    
 
 
 
Total
   $ 32,402      $ —        $ —        $ 32,402  
  
 
 
    
 
 
    
 
 
    
 
 
 
Money market funds were valued by the Company using quoted prices in active markets for identical securities, which represent a Level 1 measurement within the fair value hierarchy. During the nine months ended September 30, 2023 and the year ended December 31, 2022, there were no transfers between Level 1, Level 2 and Level 3. There have been no impairments of the Company’s assets measured and carried at fair value during the nine months ended September 30, 2023 and the year ended December 31, 2022.
The Company issued convertible notes totaling $30,000,000 during the period year ended December 31, 2022. The Company concluded that the Convertible Notes and its related features are within the scope of ASC 825,
Financial Instruments
, as a combined financial instrument, and the Company elected the fair value option where changes in fair value of the Convertible Notes are measured through the accompanying consolidated statement of operations and comprehensive loss until settlement. The Convertible Notes liability represents a Level 3 measurement within the fair value hierarchy as it has been valued using certain unobservable inputs. These inputs include the underlying fair value of the equity instrument into which the Convertible Notes are convertible. The fair value is based on significant inputs not observable in the market, namely potential financing scenarios, the likelihood of such scenarios, the expected time for each scenario to occur, and the required m
a
rket rates of return utilized in modeling these scenarios.
 
September 30, 2023
  
Scenario 1
   
Scenario 2
   
Scenario 3
 
Probability of each scenario
     70.0 %      25.0 %      5.0 % 
Expected Term (years)
     0.34       0.34       0.50  
Required market rates of return
     15.0 %      15.0 %      15.0 % 
The Convertible Notes had an estimated fair value of $37.4 million as of September 30, 2023. The Company recorded in other income (expense), net an interest expense of $1.1 million and a charge of $3.9 million on the change in estimated fair value during the nine months ended September 30, 2023. There was no change in fair value attributable to the instrument-specific credit risk for the nine-month period ended September 30, 2023.
 
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4. Property and Equipment, Net
Property and equipment, net consisted of the following as of (in thousands):
 
    
September 30,
2023
    
December 31,
2022
 
Lab equipment
  
$
1,382
 
   $ 1,382  
Furniture and fixtures
  
 
341
 
     341  
Computer equipment
  
 
85
 
     85  
Leasehold improvements
  
 
940
 
     935  
  
 
 
    
 
 
 
Total property and equipment
  
 
2,748
 
     2,743  
Less accumulated depreciation
  
 
(842
) 
     (467 ) 
  
 
 
    
 
 
 
Property and equipment, net
  
$
1,906
 
   $ 2,276  
  
 
 
    
 
 
 
Depreciation expense for the nine months ended September 30, 2023 and 2022 was $0.4 million and $0.2 million, respectively. No impairment losses occurred in the nine months ended September 30, 2023 and 2022.
5. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following as of (in thousands):
 
    
September 30,
2023
    
December 31,
2022
 
Payroll tax credit
  
$
666
 
   $ 948  
Prepaid external research and development
  
 
1,543
 
     1,329  
Research credit receivable
  
 
14
 
     116  
Prepaid expenses
  
 
521
 
     421  
Other
  
 
101
 
     146  
  
 
 
    
 
 
 
Total prepaid expenses and other current assets
  
$
2,845
 
   $ 2,960  
  
 
 
    
 
 
 
6. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following as of (in thousands):
 
    
September 30,
2023
    
December 31,
2022
 
Accrued external research and development
  
$
2,990
 
   $ 4,077  
Accrued compensation and related expenses
  
 
2,174
 
     2,791  
Accrued interest
  
 
—  
 
     376  
Accrued taxes payable
  
 
65
 
     570  
Operating lease liability, current
  
 
521
 
     471  
Accrued professional services and other
  
 
1,649
 
     1,212  
  
 
 
    
 
 
 
Total accrued expenses and other current liabilities
  
$
7,399
 
   $ 9,497  
  
 
 
    
 
 
 
7. Commitments and Contingencies
As of September 30, 2023, the Company has several ongoing clinical studies in various clinical trial stages. Its most significant contracts relate to agreements with clinical research organizations (CROs) for clinical trials and preclinical studies and contract development and manufacturing organizations (CMOs), which the Company enters into in the normal course of business. The contracts with CROs and CMOs are generally cancellable, with notice, at the Company’s option.
 
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License Agreements
License Agreement with the University of Colorado
In August 2017, the Company entered into an exclusive license agreement, as amended in February 2018, September 2018, and April 2019 (the Colorado License Agreement), with The Regents of the University of Colorado (Colorado), pursuant to which the Company obtained worldwide, royalty-bearing, sublicensable licenses under certain patents and
know-how
owned by Colorado and Medical University of South Carolina (MUSC) relating to the research, development and commercialization of
ADX-097.
The licenses granted to the Company are exclusive with respect to certain patent families and
know-how
and
non-exclusive
with certain other patent families and
know-how.
The licenses granted to the Company are also subject to certain customary retained rights of Colorado and MUSC and rights of the United States government owing to federal funding giving rise to inventions covered by the licensed patents. the Company agreed to use commercially reasonable efforts to develop, manufacture and commercialize
ADX-097,
including by using commercially reasonable efforts to achieve specified development and regulatory milestones by specified dates.
In addition, the Company agreed to pay Colorado (i) development and sales milestone payments in an aggregate amount of up to $2.2 million per licensed product for the first three products, (ii) tiered royalty rates on cumulative net sales of licensed products in the low single digit percentages, (iii) 15% of sublicense income and (iv) ongoing fees associated with the prosecution, maintenance, or filing of the licensed patents. the Company’s obligation to pay royalties to Colorado commences, on a licensed
product-by-licensed
product and
country-by-country
basis, from the first commercial sale of a licensed product in any country and expires on the later of (a) the last to expire valid claim within the licensed patents covering such licensed product in such country, and (b) 20 years following the effective date of the Colorado License Agreement, or April 2037 (the Royalty Term).
Unless earlier terminated by either party pursuant to its terms, the Colorado License Agreement will expire upon the expiration of the Royalty Term in all countries. The Company may terminate the Colorado License Agreement for convenience upon providing prior written notice to Colorado. Colorado may terminate the Colorado License Agreement or convert the Company’s exclusive license to a
non-exclusive
license if the Company breaches certain obligations under the Colorado License Agreement and fails to cure such breach. The Colorado License Agreement will terminate automatically upon the Company’s dissolution, insolvency, or bankruptcy.
During the nine months ended September 30, 2023 and 2022, the Company recorded zero and $50 thousand, respectively in research and development expense for milestone related to the Colorado License Agreement. The financial statements as of September 30, 2023 and December 31, 2022 do not include liabilities with respect to royalty fees on the license agreement as the Company has not yet generated revenue and the achievement of certain milestones is not yet probable.
License Agreement with Bristol-Myers Squibb Company
In September 2019, the Company entered into a license agreement, as amended in August 2021 and July 2022 (the BMS License Agreement), with Bristol-Myers Squibb Company (BMS), pursuant to which the Company obtained sublicensable licenses from BMS to research, develop and commercialize licensed products, including bempikibart, for any and all uses worldwide. The licenses granted to the Company are exclusive with respect to BMS’s patent rights and
know-how
relating to certain antibody fragments (including certain fragments of bempikibart) and
non-exclusive
with respect to BMS’s patent rights and
know-how
relating to the composition of matter and use of a specific region of bempikibart. BMS retained the right for it and its affiliates to use the exclusively licensed patents and
know-how
for internal, preclinical research purposes. Under the BMS License Agreement, the Company is prohibited from engaging in certain clinical development or commercialization of any antibody other than a licensed compound with the same mechanism of action until the earlier of the expiration of Q32’s obligation to pay BMS royalties or September 2029.
 
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In consideration for the license, the Company made an upfront payment to BMS of $8 million, issued 6,628,788 Series A preferred shares to BMS and agreed to use commercially reasonable efforts to develop and commercialize at least one licensed product in key geographic markets. In addition, the Company agreed to pay BMS (i) development and regulatory milestone payments in aggregate amounts ranging from $32 million to $49 million per indication for the first three indications and commercial milestone payments in an aggregate amount of up to $215 million on net sales of licensed products, (ii) tiered royalties ranging from rates in the
mid-single
digit percentages to up to 10% of net sales, with increasing rates depending on the cumulative net sales, (iii) up to 60% of sublicense income, which percentage decreases based on the development stage of bempikibart at the time of the sublicensing event, and (iv) ongoing fees associated with the prosecution, maintenance, or filing of the licensed patents.
The Company’s obligation to pay BMS royalties under subsection (ii) above commences, on a licensed
product-by-licensed
product and
country-by-country
basis on the first commercial sale of a licensed product in a country and expires on the later of (x) 12 years from the first commercial sale of such Licensed Product in such country, (y) the last to expire licensed patent right covering bempikibart or such licensed product in such country, and (z) the expiration or regulatory or marketing exclusivity for such licensed product in such country (Royalty Term). If the Company undergoes a change of control prior to certain specified phase of development, the development and milestone payments are subject to increase by a low double digit percentage and the royalty rates are subject to increase by a low sub single digit percentage.
Unless terminated earlier by either party pursuant to its terms, the BMS License Agreement will expire on a
country-by-country
and licensed
product-by-licensed
product basis upon the expiration of the last to expire Royalty Term with respect to such licensed product in such country. Either party may terminate the BMS License Agreement for the other party’s material breach, subject to a specified notice and cure period. BMS may terminate the BMS License Agreement if the Company fails to meet its diligence obligations under the BMS License Agreement, for the Company’s insolvency, or if the Company or its affiliates challenges the validity, scope, enforceability, or patentability of any of the licensed patents. The Company may terminate the BMS License Agreement for any reason upon prior written notice to BMS, with a longer notice period if a licensed product has received regulatory approval. If the BMS Agreement is terminated for the Company’s material breach, BMS will regain rights to bempikibart and the Company must grant BMS an exclusive license under the Company’s patent rights covering bempikibart, subject to a low single digit percentage royalty on net sales of bempikibart payable to the Company by BMS.
During the year ended December 31, 2019, the Company recorded
in-process-research
and development expense of $14.6 million in the statement of operations related to the BMS License Agreement comprised of $8.0 million of cash consideration and $6.6 million of Series A preferred shares issued to BMS.
As of September 30, 2023, no events have occurred that would require payment of the milestones, royalties or sublicense fees.
Legal Proceedings
The Company is not currently party to any material legal proceedings. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of FASB ASC Topic 450,
Contingencies
. The Company expenses as incurred the costs related to its legal proceedings.
Indemnification Arrangements
As permitted under Delaware law, the Company has agreements whereby it indemnifies certain of its investors, stockholders, employees, officers, and directors (collectively, the Indemnified Parties) for certain events or occurrences while the Indemnified Parties are, or were serving, at its request in such capacity. The maximum
 
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potential amount of future payments the Company could be required to make under these indemnification agreements is unlimited; however, the Company has an Executive Liability insurance policy that limits its exposure and enables it to recover a portion of any future amounts paid up to $5.0 million. The Company believes the estimated fair value of these indemnification agreements is minimal. The Company enters into standard indemnification agreements in the ordinary course of business. Pursuant to these agreements, the Company indemnifies, holds harmless, and agrees to reimburse the Indemnified Parties for losses suffered or incurred by the Indemnified Parties, generally the Company’s business partners or customers, in connection with any U.S. patent or any copyright or other intellectual property infringement claim by any third party with respect to the Company’s products. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is unlimited. The Company has never incurred costs to defend lawsuits or settle claims related to these indemnification agreements.
8. Debt
Venture Debt
On December 11, 2020 (the Effective Date), the Company entered into a Loan and Security Agreement with Silicon Valley Bank, a California corporation (the Loan Agreement) for a lending facility of up to $25 million. The Company received $5.0 million loan upon execution of the Agreement (Term A Loan Advance) and had the ability to draw up to $20.0 million in three separate term loan advances if certain performance milestones are met. The term loan bears interest at an annual rate equal to the greater of the prime rate or 3.25%. The Loan Agreement provides for interest-only payments until April 30, 2022, and repayment of the aggregate outstanding principal balance of the term loan in monthly installments starting on July 1, 2022 through December 1, 2023. The commencement of principal payments and the maturity date will be deferred by one year upon the occurrence of a contingent event. In addition, the Company paid a fee of $91 thousand upon closing and is required to pay a fee of 2.0% of the aggregate amount of advances under the Loan Agreement at maturity. At its option, the Company may elect to prepay all or a portion of the outstanding advances by paying the principal balance and all accrued and unpaid interest and a prepayment premium. In connection with the Loan Agreement, the Company granted the lender a security interest in all of its personal property now owned or hereafter acquired, excluding intellectual property (but including the rights to payment and proceeds from the sale, licensing or disposition of intellectual property), and a negative pledge on intellectual property. The Loan Agreement also contains certain events of default, representations, warranties and
non-financial
covenants of the Company. If the Company fails to make payments when due or breaches any operational covenant or has any event of default, this could have a material adverse effect on its business and financial condition. The Company was in compliance with all covenants at September 30, 2023 and December 31, 2022.
On June 30, 2022, a second amendment to the Loan Agreement was entered into with the lender that extended the interest-only payment until December 31, 2022 followed by 24 equal monthly payments of principal plus interest. The loan matures on December 31, 2024. The amendment increases the final payment from 2.0% to 4.0% of the advanced payment and modifies the prepayment premium.
On August 10, 2022, a third amendment to the Loan Agreement was entered into with the lender. Per the terms of the amendment and in conjunction with the Collaboration Agreement (as defined below), the Company transferred $5.0 million into a restricted cash collateral money market account which is included as Restricted cash and restricted cash equivalents on the balance sheet. This restricted cash equivalent covers the amount of the debt outstanding as of the third amendment effective date.
On December 21, 2022, a fourth amendment to the Loan Agreement was entered into with the lender that extended the interest-only payment until July 1, 2023 followed by 18 equal monthly payments of principal plus interest. The loan matures on December 1, 2024.
On April 26, 2023, a fifth amendment to the Loan Agreement was entered into with the lender. The amendment provides that the Company must maintain at least 50% of its consolidated cash with the lender. In addition, the
 
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Company shall at all times have on deposit in operating and depository accounts maintained with the lender, unrestricted and unencumbered cash in an amount equal to the lesser of (i) 100% of the dollar value of the Company’s consolidated cash and (ii) 110% of the then-outstanding obligations of the Company to the bank. So long as, the Company is in compliance with those terms, the Company shall be permitted to maintain accounts with other banks or financial institutions.
On July 12, 2023, a sixth amendment to the Loan Agreement was entered into with the lender. The amendment provides for one term loan advance (the 2023 Term A loan advance) in an original principal amount of $5.5 million and required the Company to repay the outstanding 2020 Term A Loan Advance of $5.0 million, including the final payment of $0.2 million. Upon the occurrence of a contingent event, the lender shall make up to three additional term loan advances at the Company’s request in original principal amounts of $7.0 million, $7.5 million and $5.0 million. The amounts must be drawn by the Company before March 31, 2024, March 31, 2025 and July 1, 2025, respectively. The interest-only period extends through June 30, 2024 followed by 36 equal monthly payments of principal plus interest. The term loan bears interest at an annual rate equal to the greater of the prime rate minus 0.25%, or 8.00%.
On November 2, 2023, a seventh amendment to the Loan Agreement was entered into with the lender. The additional loan advance of $7.0 million, the first advance stated in the sixth amendment to the Loan Agreement, could be drawn down once the company received net proceeds of $75.0 million. The seventh amendment extends the time the Company has to receive the net proceeds to March 31, 2024 and provides that $37.5 million of the total $75 million requirement must be through the issuance and sale of equity securities.
In conjunction with the Loan Agreement, the Company issued warrants to purchase 166,371 shares of common stock to the lender at a per share price of $0.33 with a maximum contractual term of 10 years. The warrants had a total relative fair value of $39 thousand upon issuance and were recorded as a debt discount.
In conjunction with the sixth amendment, the Company issued warrants to purchase 211,528 shares of common stock to the lender at a per share price of $0.36 with a maximum contractual term of 10 years. The warrants are issued in two separate tranches of 105,764 based upon certain milestone events. The warrants had a de minimis total relative fair value at the time of issuance.
Pursuant to ASC Topic 480,
Distinguishing Liabilities from Equity
and ASC Topic 815,
Derivatives and Hedging
, the Warrants were classified as equity and were initially measured at fair value. Subsequent changes to fair value will not be recognized so long as the instrument continues to be equity classified.
Interest expense was $0.3 million and $0.2 million for the nine months ended September 30, 2023 and 2022, respectively. The effective rate on the Loan Agreement, including the amortization of the debt discount and issuance costs was 10.42% and 9.49% at September 30, 2023 and December 31, 2022, respectively. The components of the long-term debt balance are as follows (in thousands):
 
    
September 30,
2023
    
December 31,
2022
 
Principal amount of term loans
  
$
5,500
 
   $ 5,000  
Unamortized debt discount and issuance costs
  
 
(71
) 
     72  
  
 
 
    
 
 
 
Carrying amount
  
 
5,429
 
     5,072  
Less current portion
  
 
418
 
     —    
  
 
 
    
 
 
 
Long-term debt, net
  
$
5,011
 
   $ 5,072  
  
 
 
    
 
 
 
Convertible Notes
On May 20, 2022, the Company entered into an agreement with the existing investors of the company to purchase up to an aggregate of $30.0 million in convertible notes (the Convertible Notes) through December 31,
 
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2022. The Convertible Notes bear interest at 5.0% per annum. The Convertible Notes become due on demand of the Convertible Noteholders one year from the date of issuance. On May 20, August 5 and December 23, 2022, the Company received $8.3 million, $5.0 million, and $16.7 million, respectively, in exchange for issuance of the Convertible Notes.
The Convertible Notes contain mandatory conversion features whereby the total outstanding amount of principal and accrued and unpaid interest of the Convertible Notes shall automatically convert into shares of common stock upon certain qualified financings. The total outstanding amount of principal and accrued and unpaid interest of the Convertible Notes convert into common shares at 90% of the purchase price of the mandatory conversion events.
If the mandatory conversion events do not occur the holders of the Convertible Notes may request the Convertible Notes plus accrued interest to be converted into Series B preferred stock at the Series B convertible price of $1.0971.
The Company has elected to account for the Convertible Notes at fair value where changes in fair value of the notes are measured through the consolidated statements of operations and comprehensive loss until settlement. As the Convertible Notes are due on demand. the Company recorded the convertible notes at fair value totaling $37.4 million within current liabilities on its condensed consolidated balance sheet as of September 30, 2023. The Company recorded in other income (expense), net an interest expense of $1.1 million and a charge of $3.9 million related to the change in estimated fair value during the nine months ended September 30, 2023.
9. Common Stock
As of September 30, 2023 the Second Amended and Restated Certificate of Incorporation authorized the Company to issue 141,900,000 shares of common stock, $0.0001 par value per share, respectively.
The Company has reserved the following shares of common stock for future issuance:
 
    
As of
September 30,
2023
    
As of
December 31,
2022
 
Shares reserved upon the conversion of authorized Series A preferred stock
  
 
47,628,788
 
     47,628,788  
Shares reserved upon the conversion of authorized Series A1 preferred stock
  
 
6,500,000
 
     6,500,000  
Shares reserved upon the conversion of authorized Series B preferred stock
  
 
54,689,627
 
     54,689,627  
Shares reserved for future issuance under the 2017 Stock Incentive Plan
  
 
1,221,039
 
     1,669,058  
Shares reserved for stock option exercises
  
 
23,326,570
 
     22,997,639  
Shares reserved for warrants
  
 
377,899
 
     166,371  
  
 
 
    
 
 
 
  
 
133,743,923
 
     133,651,483  
  
 
 
    
 
 
 
10. Stock-Based Compensation
Grants under the 2017 Plan
The Company adopted the 2017 Stock Option and Grant Plan and subsequent amendments (the Plan) with 25,956,535 shares of common stock reserved for issuance to employees, directors, and consultants. The Plan allows for the grant of incentive stock options,
non-statutory
stock options, restricted stock awards, restricted stock unit awards and other stock awards. Recipients of stock options are eligible to purchase shares of the
 
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Company’s common stock at an exercise price equal to the estimated fair market value of such stock on the date of grant. The maximum contractual term of options granted under the Plan is ten years, and the awards vest under such terms prescribed by the Company’s Board.
Since inception, the Company has granted restricted stock awards,
non-qualified
stock options and incentive stock options. As of September 30, 2023, 1,221,039 shares remain available for future grant under the Plan.
Stock Options
Stock options granted by the Company typically vest over a four-year period and have a
ten-year
contractual term. The following table summarizes the Company’s stock option activity under the 2017 Plan during the nine months ended September 30, 2023:
 
    
Number of
Shares
    
Weighted-
Average
Exercise
Price
    
Weighted-
Average
Remaining
Contractual
Term
(In Years)
    
Aggregate
Intrinsic
Value (in
thousands)
 
Outstanding at December 31, 2022
     22,997,639      $ 0.34        7.94      $ 362  
Granted
     2,098,138        0.36        —       
Exercised
     (119,088 )       0.26        —       
Cancelled
     (1,650,119 )       0.35        —       
  
 
 
    
 
 
    
 
 
    
 
 
 
Outstanding at September 30, 2023
     23,326,570      $ 0.34        7.33      $ 349  
  
 
 
    
 
 
    
 
 
    
 
 
 
Exercisable at September 30, 2023
     11,937,586      $ 0.32        5.96      $ 348  
  
 
 
    
 
 
    
 
 
    
 
 
 
The weighted-average grant date fair value per share of options granted in the period ended September 30, 2023 was $0.26. The total fair value of options vested for the nine months ended September 30, 2023 was $1.0 million. As of September 30, 2023, total unrecognized compensation costs to the unvested stock options were approximately $2.9 million, which are expected to be recognized over a weighted-average period of 2.6 years.
Stock-Based Compensation Expense
For purposes of calculating stock-based compensation, the Company estimates the fair value of stock options using the Black-Scholes option-pricing model. This model incorporates various assumptions, including the expected volatility, expected term, and interest rates.
The underlying assumptions used to value stock options granted using the Black-Scholes option-pricing model during the nine months ended September 30, 2023 were as follows:
 
    
Nine months ended September 30,
 
    
2023
   
2022
 
Risk-free interest rate range
     3.59% –4.14 %      1.74% – 3.16 % 
Expected dividend rate
     —         —    
Expected term (years) range
     5.45 –6.12     6.00 – 6.11  
Expected stock price volatility range
     88.9% – 89.8 %      85.9% – 86.3 % 
Risk-Free Interest Rate –
The risk-free rate assumption is based on the U.S. Treasury instruments, the terms of which were consistent with the expected term of the Company’s stock options.
Expected Dividend –
The expected dividend assumption is based on the Company’s history and expectation of dividend payouts. The Company has not paid and does not intend to pay dividends.
 
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Expected Term –
The expected term of stock options represents the weighted average period the stock options are expected to be outstanding. The Company uses the simplified method for estimating the expected term, which calculates the expected term as the average
time-to-vesting
and the contractual life of the options for stock options issued to employees. The expected term for options granted to
non-employees
is based on the contractual life of the options.
Expected Volatility –
Due to the Company’s limited operating history and lack of company-specific historical or implied volatility, the expected volatility assumption was determined by examining the historical volatilities of a group of industry peers whose share prices are publicly available. The Company expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded stock price.
Fair Value of Common Stock
–
As there has been no public market for the Company’s common stock to date, the estimated fair value of its common stock has been determined by its most recently available third-party valuations of common stock. These third-party valuations were performed in accordance with the guidance outlined in the American Institute of Certified Public Accountants’ Accounting and Valuation Guide,
Valuation of Privately-Held-Company Equity Securities Issued as Compensation
. The Company’s common stock valuations were prepared using an option pricing method, or OPM. The OPM treats common stock and preferred stock as call options on the total equity value of a company, with exercise prices based on the value thresholds at which the allocation among the various holders of a company’s securities changes. Under this method, the common stock has value only if the funds available for distribution to stockholders exceeded the value of the preferred stock liquidation preferences at the time of the liquidity event, such as a strategic sale or a merger. A discount for lack of marketability of the common stock is then applied to arrive at an indication of value for the common stock. There are significant judgments and estimates inherent in the determination of the fair value of the Company’s common stock. These estimates and assumptions include a number of objective and subjective factors, including external market conditions, the prices at which the Company sold shares of preferred securities, the superior likelihood of, achieving a liquidity event, such as an IPO or sale. Significant changes to the key assumptions used in the valuations could result in different fair values of common stock at each valuation date.
Stock-Based Compensation Expense
The Company recorded stock-based compensation expense in the following expense categories of its statements of operations (in thousands):
 
    
Nine months ended
September 30,
 
    
2023
    
2022
 
Research and development
  
$
360
 
   $ 342  
General and administrative
  
 
546
 
     578  
  
 
 
    
 
 
 
Total stock-based compensation expense
  
$
906
 
   $ 920  
  
 
 
    
 
 
 
11. Agreements with Horizon
As of September 30, 2023, the Company has received $55.0 million of the $55.0 million transaction price from Horizon Therapeutics Ireland DAC (Horizon). The Company recognized $8.0 million of collaboration agreement revenue for the nine months ended September 30, 2023. As of September 30, 2023, approximately $40.3 million remains in collaboration deferred revenue, of which $24.8 million is included in deferred revenue, current portion and $15.5 million is included in deferred revenue, net of current portion on the consolidated balance sheets, based on anticipating timing of recognition of the amounts.
The Company concluded that the consideration allocated to the research service performance obligations should be recognized over time as Horizon receives the benefit of the research activities as the activities are performed.
 
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The Company determined that this method is most appropriate as progress towards completion of research is largely driven by time and effort spent and costs incurred to perform this research. There are significant judgments and estimates inherent in the determination of the costs to be incurred for the research and development activities related to the collaboration with Horizon. These estimates and assumptions include a number of objective and subjective factors, including the potential third-party costs related to each of the Phase 2 clinical trial. Any changes to these estimates will be recognized in the period in which they change as a cumulative
catch-up.
The consideration allocated to the material right would have been included in the consideration associated with the sale of
ADX-914
if the option had been exercised by Horizon or would have been recognized upon expiration of the option.
12. Related Party Transactions
The Company has consulting and advisory agreements with certain investors and board members which are considered related party transactions. For the nine months ended September 30, 2023 and the year ended December 31, 2022, the Company recorded expense of $19 thousand and $87 thousand, respectively, related to services provided by these investors.
No amounts were due to related parties at September 30, 2023 or December 31, 2022.
13. Income Taxes
The Company record a provision for income taxes of $65 thousand and $45 thousand for the nine months ended September 30, 2023 and September 30, 2022, respectively. The Company’s effective tax rate of 0.2% differs from the U.S. statutory tax rate of 21.0% primarily as a result of the valuation allowance maintained against the Company’s net deferred tax assets.
The Company has evaluated the positive and negative evidence involving its ability to realize its deferred tax assets and has considered its history of cumulative net losses incurred since inception and its lack of any commercially ready products. The Company has concluded that it is more likely than not that it will not realize the benefits of its deferred tax assets. The Company reevaluates the positive and negative evidence at each reporting period.
14. Net Loss per Share
Basic and diluted loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average common shares outstanding.
The Company’s potentially dilutive securities, which include convertible preferred stock, convertible notes, unvested restricted common stock, and stock options, have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The Company excluded the following from the computation of diluted net loss per share attributable to common stockholders because including them would have had an anti-dilutive effect:
 
    
Nine months ended
September 30,
 
    
2023
    
2022
 
Series A convertible preferred stock
     47,628,788        47,628,788  
Series
A-1
convertible preferred stock
     6,500,000        6,500,000  
Series B convertible preferred stock:
     54,689,627        54,689,627  
Unvested restricted common stock
     —          3,232  
Options to purchase common stock
     23,326,570        15,955,557  
 
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In addition, during the year ended December 31, 2022 the Horizon Agreements, the Company issued convertible notes with a principal balance of $30.0 million. These convertible notes and any accrued interest may convert into either a variable number of common shares or into shares of Series B Preferred Stock based on a fixed exchange ratio. Any shares of Series B Preferred Stock issued to settle the convertible notes would then be convertible into shares of common stock.
15. Subsequent Events
The Company has completed an evaluation of all subsequent events after the unaudited condensed consolidated balance sheet date of September 30, 2023 through December 15, 2023, the date these condensed consolidated financial statements were issued, to ensure that these condensed consolidated financial statements include appropriate disclosure of events both recognized in the condensed consolidated financial statements as of September 30, 2023, and events which occurred subsequently but were not recognized in the condensed consolidated financial statements.
Non-recognizable
subsequent events through December 15, 2023 are summarized below.
Rights to Bempikibart (formerly
ADX-914)
As more fully discussed in Note 1 and Note 11, on August 12, 2022, the Company entered into a Collaboration and Option Agreement (the Horizon Collaboration Agreement) and an Asset Purchase Agreement (the Purchase Agreement, collectively with the Horizon Collaboration Agreement, the Horizon Agreements) with Horizon Therapeutics Ireland DAC (Horizon). Under the terms of the Horizon Agreements, the Company received an initial consideration and development funding under the bempikibart program totaling $55.0 million, which funded two ongoing Phase 2 trials for bempikibart. Horizon had an option to acquire bempikibart the program at a prespecified price, subject to certain adjustments. In October 2023, Amgen Inc. (Amgen) completed its acquisition of Horizon Therapeutics public limited company (Horizon plc). Following the closing of Amgen’s acquisition of Horizon plc, the Company agreed with Amgen to mutually terminate the Horizon Agreements and in November 2023, the Company and Horizon entered into a termination agreement (the Horizon Termination Agreement), pursuant to which Horizon’s option to acquire the bempikibart program was terminated. As a result, the Company retained all initial consideration and development funding received under the Horizon Collaboration Agreement and regained full development and commercial rights to bempikibart. In consideration for the Horizon Termination Agreement, the Company agreed to pay Horizon regulatory and sales milestones payments of up to an aggregate amount of $75.1 million upon the first achievement of certain regulatory and sales milestones with respect to bempikibart.
Amendment to Loan Agreement
On November 2, 2023, the Company executed a seventh amendment to the Loan Agreement. See Note 8 for details on the Loan Agreement and amendments.
Proposed Merger with Homology
On November 16, 2023, the Company entered into the Merger Agreement with Homology. See Note 1 for details.
 
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Amendment to Certificate of Incorporation
On November 16, 2023, the Company amended its Second Amended and Restated Certificate of Incorporation to increase the number of its authorized common stock by 83,100,000 shares from 141,900,000 shares to 225,000,000 shares
Stock Option Grants
In November 2023, the Company granted under the 2017 Stock Option Plan, 1,123,354, stock options to five individuals, which included new employees, executives and one consultant. Stock options were issued with an exercise price of $0.82 per share. The stock option awards vest in accordance with terms typically granted under the 2017 Stock Option Plan.
 
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Annex A

Execution Version

 

AGREEMENT AND PLAN OF MERGER

by and among:

HOMOLOGY MEDICINES, INC.;

KENOBI MERGER SUB, INC.;

and

Q32 BIO INC.

Dated as of November 16, 2023


Table of Contents

TABLE OF CONTENTS

 

               Page  

ARTICLE I DEFINITIONS AND INTERPRETATIVE PROVISIONS

     2  
   1.1    Definitions      2  
   1.2    Other Definitional and Interpretative Provisions      16  

ARTICLE II THE MERGER

     17  
   2.1    The Merger      17  
   2.2    Closing      17  
   2.3    Organizational Documents; Directors and Officers      17  
   2.4    Conversion of Shares      17  
   2.5    Contingent Value Right.      19  
   2.6    Closing of Q32’s Transfer Books      20  
   2.7    Surrender of Q32 Common Stock      20  
   2.8    Calculation of Net Cash      20  
   2.9    Further Action      22  
   2.10    Withholding      22  

ARTICLE III REPRESENTATIONS AND WARRANTIES OF Q32

     22  
   3.1    Due Organization; Subsidiaries      22  
   3.2    Organizational Documents      23  
   3.3    Authority; Binding Nature of Agreement      23  
   3.4    Vote Required      23  
   3.5    Non-Contravention; Consents      23  
   3.6    Capitalization      24  
   3.7    Financial Statements      25  
   3.8    Absence of Changes      26  
   3.9    Absence of Undisclosed Liabilities      26  
   3.10    Title to Assets      26  
   3.11    Real Property; Leasehold      26  
   3.12    Intellectual Property      26  
   3.13    Agreements, Contracts and Commitments      30  
   3.14    Compliance; Permits; Restrictions      32  
   3.15    Legal Proceedings; Orders      33  
   3.16    Tax Matters      33  
   3.17    Employee and Labor Matters; Benefit Plans      35  
   3.18    Environmental Matters      37  
   3.19    Insurance      37  
   3.20    Transactions with Affiliates      37  
   3.21    No Financial Advisors      37  
   3.22    Privacy and Data Security      38  
   3.23    Concurrent Financing      38  
   3.24    No Other Representations or Warranties      39  

ARTICLE IV REPRESENTATIONS AND WARRANTIES OF HOMOLOGY AND MERGER SUB

     39  
   4.1    Due Organization; Subsidiaries      39  
   4.2    Organizational Documents      40  
   4.3    Authority; Binding Nature of Agreement      40  
   4.4    Vote Required      40  
   4.5    Non-Contravention; Consents      40  

 

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   4.6    Capitalization      41  
   4.7    SEC Filings; Financial Statements      42  
   4.8    Absence of Changes      44  
   4.9    Absence of Undisclosed Liabilities      44  
   4.10    Title to Assets      44  
   4.11    Real Property; Leasehold      44  
   4.12    Intellectual Property      44  
   4.13    Agreements      48  
   4.14    Compliance; Permits; Restrictions      50  
   4.15    Legal Proceedings; Orders      51  
   4.16    Tax Matters      52  
   4.17    Employee and Labor Matters; Benefit Plans      53  
   4.18    Environmental Matters      55  
   4.19    Insurance      55  
   4.20    Transactions with Affiliates      56  
   4.21    No Financial Advisors      56  
   4.22    Valid Issuance; No Bad Actor      56  
   4.23    Privacy and Data Security      56  
   4.24    No Other Representations or Warranties      57  

ARTICLE V COVENANTS

     57  
   5.1    Conduct of Q32’s Business      57  
   5.2    Conduct of Homology’s Business      58  
   5.3    Access and Investigation.      60  
   5.4    No Solicitation.      61  
   5.5    Notification of Certain Matters      62  
   5.6    Legacy Asset Disposition      62  
   5.7    Registration Statement; Proxy Statement      63  
   5.8    Q32 Stockholder Written Consent.      64  
   5.9    Homology Stockholder Meeting.      65  
   5.10    Efforts; Regulatory Approvals.      66  
   5.11    Disclosures      67  
   5.12    Homology Options      67  
   5.13    Homology Restricted Stock Unit Awards      67  
   5.14    Homology ESPP      67  
   5.15    Indemnification of Officers and Directors      68  
   5.16    Tax Matters      69  
   5.17    Listing      70  
   5.18    Legends      70  
   5.19    Officers and Directors      70  
   5.20    Termination of Certain Agreements and Rights      71  
   5.21    Section 16 Matters      71  
   5.22    Allocation Certificate      71  
   5.23    Nasdaq Reverse Split      71  
   5.24    Obligations of Merger Sub      71  
   5.25    Takeover Statutes      71  
   5.26    Stockholder Litigation      71  
   5.27    Concurrent Financing      72  
   5.28    Homology Equity Plans      72  
   5.29    Homology 401(k) Plan      73  

 

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ARTICLE VI CONDITIONS TO CONSUMMATION OF THE MERGER

     73  
   6.1    Conditions Precedent to Obligations of Each Party      73  
   6.2    Conditions Precedent to Obligations of Q32      74  
   6.3    Conditions Precedent to Obligations of      74  
   6.4    Frustration of Closing Conditions      75  

ARTICLE VII CLOSING DELIVERIES

     75  
   7.1    Closing Deliveries of Q32      75  
   7.2    Closing Deliveries of Homology      75  

ARTICLE VIII TERMINATION

     76  
   8.1    Termination      76  
   8.2    Effect of Termination      77  
   8.3    Expenses; Termination Fees.      77  

ARTICLE IX GENERAL PROVISIONS

     78  
   9.1    Non-Survival of Representations and Warranties      78  
   9.2    Amendment      78  
   9.3    Waiver      78  
   9.4    Entire Agreement; Counterparts; Exchanges by Electronic Transmission or Facsimile      79  
   9.5    Applicable Law; Jurisdiction      79  
   9.6    Assignability      79  
   9.7    Notices      79  
   9.8    Cooperation      80  
   9.9    Severability      80  
   9.10    Other Remedies; Specific Performance      80  
   9.11    No Third-Party Beneficiaries      81  

EXHIBITS

 

Exhibit A    Form of Homology Stockholder Support Agreement
Exhibit B    Form of Q32 Stockholder Support Agreement
Exhibit C    Form of Homology Lock-Up Agreement
Exhibit D    Form of Q32 Lock-Up Agreement
Exhibit E    Form of CVR Agreement

 

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AGREEMENT AND PLAN OF MERGER

THIS AGREEMENT AND PLAN OF MERGER (this “Agreement”) is made and entered into as of November 16, 2023, by and among HOMOLOGY MEDICINES, INC., a Delaware corporation (“Homology”), KENOBI MERGER SUB, INC., a Delaware corporation and a direct, wholly owned subsidiary of Homology (“Merger Sub”), and Q32 BIO INC., a Delaware corporation (“Q32”). Certain capitalized terms used in this Agreement are defined in Section 1.1.

RECITALS

A. Homology and Q32 intend to effect a merger of Merger Sub with and into Q32 (the “Merger”) in accordance with this Agreement and Delaware Law. Upon consummation of the Merger, Merger Sub will cease to exist and Q32 will become a wholly owned subsidiary of Homology.

B. The board of directors of Homology (the “Homology Board”) has (i) determined that the Contemplated Transactions are fair to, advisable and in the best interests of Homology and its stockholders, (ii) approved and declared advisable this Agreement and the Contemplated Transactions, including the issuance of shares of Homology Common Stock to the stockholders of Q32 pursuant to the terms of this Agreement, the change of control of Homology and the other actions contemplated by this Agreement, and (iii) determined to recommend, upon the terms and subject to the conditions set forth in this Agreement, that the stockholders of Homology vote to (a) approve the issuance of Homology Common Stock in the Merger and the change of control resulting from the Merger in accordance with Nasdaq Listing Rule 5635 (the “Nasdaq Issuance Proposal”), (b) approve an amendment to Homology’s certificate of incorporation to increase the number of authorized shares from 200,000,000 shares of Homology Common Stock to 400,000,000 shares of Homology Common Stock (the “Authorized Share Increase Proposal”) and (c) approve an amendment to Homology’s certificate of incorporation to effect the Nasdaq Reverse Split (the “Reverse Stock Split Proposal” and, together with the Authorized Share Increase Proposal, the “Charter Amendment Proposals”).

C. The board of directors of Merger Sub (the “Merger Sub Board”) has (i) determined that the Contemplated Transactions are fair to, advisable, and in the best interests of Merger Sub and its sole stockholder, (ii) approved and declared advisable this Agreement and the Contemplated Transactions and (iii) determined to recommend, upon the terms and subject to the conditions set forth in this Agreement, that the stockholder of Merger Sub votes to adopt this Agreement and thereby approve the Contemplated Transactions.

D. Concurrently with the execution and delivery of this Agreement and as a condition and inducement to Q32’s willingness to enter into this Agreement, the stockholders, officers and directors of Homology set forth on Section A of the Homology Disclosure Schedule (solely in their capacity as stockholders of Homology) are executing support agreements in favor of Q32 in substantially the form attached hereto as Exhibit A (the “Homology Stockholder Support Agreement”), pursuant to which such Persons have, subject to the terms and conditions set forth therein, agreed to vote all of their shares of Homology Common Stock in favor of this Agreement, the Nasdaq Issuance Proposal and the Charter Amendment Proposals.

E. Concurrently with the execution and delivery of this Agreement and as a condition and inducement to Homology’s willingness to enter into this Agreement, the officers, directors and stockholders (together with their Affiliates) of Q32 set forth on Section A of the Q32 Disclosure Schedule (solely in their capacity as stockholders of Q32) are executing support agreements in favor of Homology in substantially the form attached hereto as Exhibit B (the “Q32 Stockholder Support Agreement”), pursuant to which such Persons have, subject to the terms and conditions set forth therein, agreed to vote all of their shares of Q32 Capital Stock in favor of this Agreement.

F. Concurrently with the execution and delivery of this Agreement and as a condition and inducement to Q32’s willingness to enter into this Agreement, the officers and directors of Homology set forth on Section B of

 

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the Homology Disclosure Schedule are executing lock-up agreements in substantially the form attached hereto as Exhibit C (collectively, the “Homology Lock-Up Agreements”).

G. Concurrently with the execution and delivery of this Agreement and as a condition and inducement to Homology’s willingness to enter into this Agreement, the officers, directors and stockholders of Q32 set forth on Section B of the Q32 Disclosure Schedule are executing lock-up agreements in substantially the form attached hereto as Exhibit D (collectively, the “Q32 Lock-Up Agreements”).

H. It is expected that promptly after the Registration Statement is declared effective under the Securities Act, the stockholders of Q32 sufficient to adopt and approve this Agreement and the Merger as required under Delaware Law and Q32’s Organizational Documents will execute and deliver an action by written consent in order to obtain the Required Q32 Stockholder Vote in the form mutually agreed to by Homology and Q32 (each, a “Q32 Stockholder Written Consent” and collectively, the “Q32 Stockholder Written Consents”).

I. Concurrently with the execution and delivery of this Agreement, certain investors have executed a Subscription Agreement by and among Q32 and the Persons named therein (representing an aggregate commitment no less than the Concurrent Investment Amount), pursuant to which such Persons will have agreed to purchase the number of shares of Q32 Capital Stock set forth therein immediately prior to the Effective Time in connection with the Concurrent Financing (the “Subscription Agreement”).

J. Each of the parties hereto intends that, for United States federal income tax purposes, the Merger will qualify as a “reorganization” within the meaning of Section 368(a) of the Internal Revenue Code of 1986, as amended (the “Code”) and the Treasury Regulations, with respect to which each of Homology, Merger Sub, and Q32 are a “party to a reorganization” under Section 368(b) of the Code, and this Agreement is intended to constitute a “plan of reorganization” for purposes of Sections 354, 361 and 368 of the Code and within the meaning of Section 368 of the Code and Treasury Regulations Section 1.368-2(g) (the “Intended Tax Treatment”).

AGREEMENT

The Parties, intending to be legally bound, agree as follows:

ARTICLE I

DEFINITIONS AND INTERPRETATIVE PROVISIONS

1.1 Definitions.

For purposes of this Agreement (including this Section 1.1):

“2024 Equity Incentive Plan” shall mean an equity incentive plan of Homology in form and substance as agreed to by Homology and Q32 (such agreement not to be unreasonably withheld, conditioned or delayed by either Party), reserving for issuance a number of shares of Homology Common Stock to be mutually agreed upon by Homology and Q32 (such agreement not to be unreasonably withheld, conditioned or delayed by either Party).

“2024 ESPP” shall mean an “employee stock purchase plan” of Homology in form and substance as agreed to by Homology and Q32 (such agreement not to be unreasonably withheld, conditioned or delayed by either Party), reserving for issuance a number of shares of Homology Common Stock to be mutually agreed upon to by Homology and Q32 (such agreement not to be unreasonably withheld, conditioned or delayed by either Party).

“2024 Plans” shall mean both the 2024 ESPP and the 2024 Equity Incentive Plan.

 

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“Acceptable Confidentiality Agreement” means a confidentiality agreement containing terms not materially less restrictive in the aggregate to the counterparty thereto than the terms of the Confidentiality Agreement, except such confidentiality agreement need not contain any standstill, non-solicitation or no hire provisions.

“Acquisition Inquiry” means, with respect to a Party, an inquiry, indication of interest or request for information (other than an inquiry, indication of interest or request for information made or submitted by Q32, on the one hand, or Homology, on the other hand, to the other Party) that would reasonably be expected to lead to an Acquisition Proposal, other than, as applicable, with respect to the Legacy Asset Disposition and the Concurrent Financing.

“Acquisition Proposal” means, with respect to a Party, any offer or proposal, whether written or oral (other than an offer or proposal made or submitted by or on behalf of Q32 or any of its Affiliates, on the one hand, or by or on behalf of Homology or any of its Affiliates, on the other hand, to the other Party) contemplating or otherwise relating to any Acquisition Transaction with such Party, other than, as applicable, with respect to the Legacy Asset Disposition and the Concurrent Financing.

“Acquisition Transaction” means any transaction or series of related transactions (other than, as applicable, the Legacy Asset Disposition and the Concurrent Financing) involving:

(i) any merger, consolidation, amalgamation, share exchange, business combination, issuance of securities, acquisition of securities, reorganization, recapitalization, tender offer, exchange offer or other similar transaction: (A) in which a Party is a constituent entity, (B) in which a Person or “group” (as defined in the Exchange Act and the rules promulgated thereunder) of Persons directly or indirectly acquires beneficial or record ownership of securities representing more than 20% of the outstanding securities of any class of voting securities of a Party or any of its Subsidiaries or (C) in which a Party or any of its Subsidiaries issues securities representing more than 20% of the outstanding securities of any class of voting securities of such Party or any of its Subsidiaries; or

(ii) any sale, lease, exchange, transfer, license, acquisition or disposition of any business or businesses or assets that constitute or account for 20% or more of the consolidated book value or the fair market value of the assets of a Party and its Subsidiaries, taken as a whole.

“Affiliate” means, with respect to any Person, any other Person directly or indirectly controlling, controlled by, or under common control with such other Person. For purposes of this definition, “control” when used with respect to any Person means the power to direct the management and policies of such Person, directly or indirectly, whether through the ownership of voting securities or partnership or other ownership interests, by contract or otherwise, and the terms “controlling” and “controlled” have correlative meanings.

“Business Day” means any day other than a day on which banks in the State of New York are authorized or obligated to be closed.

“Cash and Cash Equivalents” means all (i) cash and cash equivalents and (ii) marketable securities, in each case determined in accordance with GAAP.

“COBRA” means the Consolidated Omnibus Budget Reconciliation Act of 1985, as set forth in Section 4980B of the Code and Part 6 of Title I of ERISA.

“Code” means the Internal Revenue Code of 1986, as amended.

“Concurrent Financing” means the issuance and sale of shares of Q32 Capital Stock in a private placement to be consummated immediately prior to the Effective Time pursuant to the Subscription Agreement with aggregate gross cash proceeds of at least the Concurrent Investment Amount.

 

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“Concurrent Financing Allocation Percentage” mean the quotient (rounded to four decimal places) determined by dividing (i) the Concurrent Financing Proceeds by (ii) the Aggregate Valuation.

“Concurrent Financing Merger Shares” means, subject to Section 2.4(g), the product determined by multiplying (i) the Post-Closing Homology Shares by (ii) the Concurrent Financing Allocation Percentage.

“Concurrent Financing Proceeds” means the proceeds resulting from the Concurrent Financing.

“Concurrent Investment Amount” means $42,000,000.

“Confidentiality Agreement” means the Confidentiality Agreement, dated as of July 31, 2023, by and between Q32 and Homology.

“Consent” means any approval, consent, ratification, permission, waiver or authorization (including any Governmental Authorization).

“Contemplated Transactions” means the Merger and the other transactions contemplated by this Agreement, including the CVR Agreement, the Concurrent Financing and the Charter Amendment Proposals.

“Contract” means, with respect to any Person, any written agreement, contract, subcontract, lease (whether for real or personal property), mortgage, license, or other legally binding commitment or undertaking of any nature to which such Person is a party or by which such Person or any of its assets are bound or affected under applicable Law.

“Delaware Law” means the General Corporation Law of the State of Delaware.

“Effect” means any effect, change, event, circumstance, or development.

“Employee Plan” means (i) each “employee benefit plan” within the meaning of Section 3(3) of ERISA whether or not subject to ERISA; (ii) any other plan, program, policy, agreement or arrangement providing for stock options, stock purchases, restricted stock, restricted stock units, phantom equity, other equity or equity-based incentives, employment agreements, bonuses, commissions, severance, retention, deferred compensation, change in control, transaction, supplemental income arrangements, vacation, retirement, pension, profit-sharing, post-retirement health and welfare, fringe, life insurance, perquisites, health, medical, dental, vision, welfare, employee assistance or similar benefits; and (iii) all other plans, programs, policies, agreements or arrangements (whether written or unwritten) providing compensation or benefits to any current or former employee, officer, director, individual independent contractor and other non-employee service provider.

“Encumbrance” means any lien, pledge, hypothecation, charge, mortgage, security interest, lease, license, option, easement, reservation, servitude, adverse title, claim, infringement, interference, option, right of first refusal, preemptive right, community property interest or restriction or encumbrance of any nature (including any restriction on the voting of any security, any restriction on the transfer of any security or other asset, any restriction on the receipt of any income derived from any asset, any restriction on the use of any asset and any restriction on the possession, exercise or transfer of any other attribute of ownership of any asset).

“Enforceability Exceptions” means the (i) Laws of general application relating to bankruptcy, insolvency and the relief of debtors and (ii) rules of law governing specific performance, injunctive relief and other equitable remedies.

“Entity” means any corporation (including any nonprofit corporation), partnership (including any general partnership, limited partnership or limited liability partnership), joint venture, estate, trust, company (including any company limited by shares, limited liability company or joint stock company), firm, society or other enterprise, association, organization or entity, and each of its successors.

 

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“Environmental Law” means any federal, state, local or foreign Law relating to pollution or protection of human health or the environment (including ambient air, surface water, ground water, land surface or subsurface strata), including any law or regulation relating to emissions, discharges, releases or threatened releases of Hazardous Materials, or otherwise relating to the manufacture, processing, distribution, use, treatment, storage, disposal, transport or handling of Hazardous Materials.

“ERISA” means the Employee Retirement Income Security Act of 1974, as amended.

“ERISA Affiliate” means, with respect to any Entity, any other Person that would be treated as a single employer with such Entity, part of the same “controlled group” as such Entity or under common control with such Entity under Sections 414(b), (c), (m) or (o) of the Code, as applicable.

“Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.

“GAAP” means United States generally accepted accounting principles.

“Governmental Authority” means any: (i) nation, state, commonwealth, province, territory, county, municipality, district or other jurisdiction of any nature, (ii) federal, state, local, municipal, foreign, supra-national or other government or institution, (iii) governmental or quasi-governmental authority of any nature (including any governmental division, department, agency, commission, bureau, instrumentality, official, ministry, fund, foundation, center, organization, unit, body or Entity and any court or other tribunal, and for the avoidance of doubt, any taxing authority) or (iv) self-regulatory organization (including Nasdaq).

“Governmental Authorization” means any: (i) permit, license, certificate, franchise, permission, variance, exception, order, approval, clearance, registration, qualification or authorization issued, granted, given or otherwise made available by or under the authority of any Governmental Authority or pursuant to any Law or (ii) right under any Contract with any Governmental Authority.

“Hazardous Materials” means any pollutant, chemical, substance and any toxic, infectious, carcinogenic, reactive, corrosive, ignitable or flammable chemical, or chemical compound, or hazardous substance, material or waste, whether solid, liquid or gas, that is subject to regulation, control or remediation under any Environmental Law, including without limitation, crude oil or any fraction thereof, and petroleum products or by-products.

“Homology Associate” means any current or former employee, officer, director, independent contractor or other non-employee service provider of Homology or any of its Subsidiaries.

“Homology Balance Sheet” means the audited balance sheet of Homology for the years ended December 31, 2021 and December 31, 2022.

“Homology Capitalization Representations” means the representations and warranties of Homology and Merger Sub set forth in Sections 4.6(a) and 4.6(d).

“Homology Contract” means any Contract: (i) to which Homology is a party, (ii) by which Homology or any Homology IP Rights or any other asset of Homology is or may become bound or under which Homology has, or may become subject to, any obligation or (iii) under which Homology has or may acquire any right or interest.

“Homology Covered Person” means, with respect to Homology as an “issuer” for purposes of Rule 506 promulgated under the Securities Act, any Person listed in the first paragraph of Rule 506(d)(1).

“Homology Employee Plan” means any Employee Plan that Homology or any of its Subsidiaries (i) sponsors, maintains, administers, or contributes to, or (ii) provides benefits under or through, or (iii) has any obligation to contribute to or provide benefits under or through, or (iv) may reasonably be expected to have any Liability with respect to, or (v) utilizes to provide benefits to or otherwise cover any Homology Associate.

 

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“Homology Equity Plans” means the Homology 2015 Stock Incentive Plan, as amended from time to time and the Homology 2018 Incentive Award Plan, as amended from time to time.

“Homology ESPP” means the Homology 2018 Employee Stock Purchase Plan, as amended from time to time.

“Homology Fundamental Representations” means the representations and warranties of Homology and Merger Sub set forth in Sections 4.1(a), 4.1(b), 4.2, 4.3, 4.4, and 4.21.

“Homology IP Rights” means all Intellectual Property that is (i) owned by or purported to be owned, whether wholly or jointly with others, by Homology or any of its Subsidiaries (“Homology Owned IP Rights”), or (ii) licensed or sublicensed to Homology or any of its Subsidiaries (“Homology Licensed IP Rights”), in each case (i) and (ii), that is necessary for, or used or held for use in, the operation of the business of Homology as presently conducted.

“Homology IP Rights Agreement” means any Contract governing, related or pertaining to any Homology IP Rights.

“Homology ITM Option” means each Homology Option with an exercise price per share less than the closing trading price of a share of Homology Common Stock on the last full trading day on which the Homology Common Stock is traded prior to the date on which the Effective Time occurs.

“Homology Lease Agreement” means that certain Lease Agreement, dated December 21, 2017, by and between Homology and BCFP One Patriots Park LLC, as may be amended or supplemented from time to time.

“Homology Legacy IP Rights” means all Intellectual Property that is (i) owned by or purported to be owned, whether wholly or jointly with others, by Homology or any of its Subsidiaries, or (ii) licensed or sublicensed to Homology or any of its Subsidiaries, in each case (i) and (ii), that is solely related to the Legacy Assets.

“Homology Material Adverse Effect” means any Effect that, considered together with all other Effects that have occurred prior to the date of determination of the occurrence of a Homology Material Adverse Effect, has had or would reasonably be expected to have a material adverse effect on the business, asset, liabilities, financial condition or results of operations of Homology or its Subsidiaries, taken as a whole; provided, however, that Effects arising or resulting from the following, alone or in combination, shall not be taken into account in determining whether there has been a Homology Material Adverse Effect: (i) the announcement of this Agreement, the pendency or the consummation of the Contemplated Transactions, including any adverse change in customer, supplier, governmental, landlord, employee or similar relationships resulting therefrom or with respect thereto (other than, in the case of this clause (i), for purposes of Section 4.3, Section 4.4, or Section 4.5) (ii) the taking of any action, or the failure to take any action, by Homology that is expressly required under the terms of this Agreement, (iii) any natural disaster or epidemics, pandemics or other force majeure events, or any act or threat of terrorism or war, any armed hostilities or terrorist activities (including any escalation or general worsening of any of the foregoing) anywhere in the world or any governmental or other response or reaction to any of the foregoing, (iv) any change in GAAP or applicable Law or the interpretation thereof, (v) general economic, financial and capital markets, political conditions or conditions, including any instability in the banking sector, including the failure or placement into receivership of any financial institution, in each case generally affecting the industries in which Homology and its Subsidiaries operate, (vi) any change in the cash position of Homology and its Subsidiaries which results from operations in the Ordinary Course of Business, or (vii) any failure of Homology to meet any projections, business plans or forecasts (provided that, this clause (vii) shall not prevent a determination that any change or effect underlying such failure to meet projections, business plans or forecasts has resulted in a Homology Material Adverse Effect (to the extent such change or effect is not otherwise excluded from this definition of Homology Material Adverse Effect)); except in each case with respect to clauses (iii), (iv) and (v), to the extent disproportionately affecting Homology and its Subsidiaries,

 

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taken as a whole, relative to other similarly situated companies in the industries in which Homology and its Subsidiaries operate.

“Homology Net Cash” means without duplication, (i) Homology’s Cash and Cash Equivalents determined, to the extent in accordance with GAAP, in a manner consistent with the manner in which such items were historically determined and in accordance with the financial statements (including any related notes) contained or incorporated by reference in the Homology Balance Sheet, minus (ii) fees and expenses of Homology incurred in connection with the Contemplated Transactions, including for the avoidance of doubt, Transaction Expenses of Homology to the extent unpaid as of the Closing, minus (iii) expenses of Homology incurred in connection with the disposition of Legacy Assets and any contingent obligations or liabilities arising from such dispositions (including the full amount of any indemnity obligations), (iv) minus any and all Liabilities of Homology (A) to any Homology Associate for change in control or transaction bonuses, retention bonuses, severance or similar compensatory payments or benefits that are due and payable as a result of the completion of the Contemplated Transactions, together with any other event (in each case, including the employer portion of any payroll or similar Taxes payable with respect thereto), (B) with respect to the unfunded or underfunded portion of any accrued employer contributions to a defined contribution or any post-retirement health and welfare benefit plan, (C) accrued but unpaid bonuses, severance and vacation or paid time off (including the employer portion of any payroll or similar Taxes payable with respect thereto), (D) with respect to accounts payable, accruals and other current liabilities (which will include the Company’s total deductible under its D&O Insurance less amounts paid prior to Closing (other than in connection with Transaction Litigation) that count toward such deductible), and (E) with respect to contractual commitments for future payments under Homology Real Estate Leases to the extent such commitments are incurred prior to Closing, plus (v) all prepaid expenses set forth on Section 1.1(a)(i) of the Homology Disclosure Schedule, plus (vi) expenses paid, or Liabilities incurred, prior to Closing, that are approved in writing to be covered and reimbursed by Homology’s D&O insurance in excess of the deductible and within overall policy limits; provided that Q32 shall have received true and complete copies of all documentation provided by Homology’s D&O insurance carrier reasonably evidencing that Homology will receive such reimbursements within ninety (90) days of the Anticipated Closing Date, plus (vii) prepaid deposits set forth on Section 1.1(b) of the Homology Disclosure Schedule, and minus (viii) the RSU Withholding Amount and the employer portion of any payroll or similar Taxes payable as a result of the vesting and settlement of each outstanding and unvested Homology Restricted Stock Unit pursuant to Section 5.13. For avoidance of doubt, (1) the Cash and Cash Equivalents received in the Concurrent Financing will be excluded from the calculation of Homology Net Cash and (2) the Cash and Cash Equivalents received from the disposition of Legacy Assets will be included in the calculation of Homology Net Cash.

“Homology Options” means options to purchase shares of Homology Common Stock granted by Homology under the Homology Equity Plans, but, for the avoidance of doubt, excluding the Homology ESPP.

“Homology Registered IP” means all Homology IP Rights that are owned or exclusively licensed by Homology or any of its Subsidiaries that are registered, filed or issued under the authority of, with or by any Governmental Authority, including all Patents, registered copyrights and registered trademarks and all applications for any of the foregoing.

“Homology Restricted Stock Unit Awards” means restricted stock unit awards covering shares of Homology Common Stock granted by Homology under the Homology 2018 Incentive Award Plan, as amended from time to time.

“Homology Triggering Event” shall be deemed to have occurred if: (i) Homology shall have failed to include in the Proxy Statement the Homology Board Recommendation, (ii) the Homology Board or any committee thereof shall have made a Homology Board Adverse Recommendation Change or approved, endorsed or recommended any Acquisition Proposal (other than with Q32), or (iii) Homology shall have entered into any letter of intent or similar document or any Contract relating to any Acquisition Proposal (other than an Acceptable Confidentiality Agreement pursuant to Section 5.4).

 

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“Intellectual Property” means any and all intellectual property and similar proprietary rights throughout the world, including any and all state, United States, international and/or foreign or other territorial or regional rights in, arising out of or associated with any of the following: (i) United States, foreign and international patents, patent applications, including all provisionals, nonprovisionals, substitutions, divisional, continuations, continuations-in-part, reissues, renewals, extensions, supplementary protection certificates, reexaminations, term extensions, confirmations, certificates of invention and the equivalents of any of the foregoing, statutory invention registrations, invention disclosures and inventions (collectively, “Patents”), (ii) trademarks, service marks, trade names, domain names, corporate names, brand names, URLs or other names and locators associated with the internet, trade dress, logos and other source identifiers, including registrations and applications for registration thereof and goodwill associated therewith and symbolized thereby, (iii) works of authorship (whether or not copyrightable) and all copyrights, copyrightable works, derivative works, including registrations and applications for registration thereof, and all renewals, extensions, restorations or reversions of the foregoing, including all rights of authorship, use, publication, publicity, reproduction, distribution, income, performance and transformation, (iv) software, including all source code, object code, firmware, development tools files, records and data, all media on which any of the foregoing is recorded, and all related documentation, (v) all inventions, invention disclosures, improvements, formulae, customer lists, trade secrets, know-how (including recipes, specifications, formulae, manufacturing and other processes, operating procedures, methods, techniques and all research and development information), technology, technical data, databases, data collections, confidential information and other proprietary rights and intellectual property, whether patentable or not, and all documentation relating to any of the foregoing, (vi) all rights to sue or recover and retain damages and costs and attorneys’ fees for the past, present or future infringement, dilution, misappropriation, or other violation of any of the foregoing anywhere in the world.

“IRS” means the United States Internal Revenue Service.

“Key Employee” means, with respect to any Person, (i) an executive officer of such Person; and (ii) any employee of such Person, that reports directly to the chief executive officer of such Person.

“Knowledge” means, with respect to an individual, that such individual is actually aware of the relevant fact or such individual would reasonably be expected to know such fact in the ordinary course of the performance of such individual’s employment responsibilities. Any Person that is an Entity shall have Knowledge if any executive officer or director of such Person as of the date such knowledge is imputed has or should reasonably be expected to have Knowledge of such fact or other matter. With respect to any matters relating to Intellectual Property, such awareness or reasonable expectation to have knowledge does not require any such individual to conduct or have conducted or obtain or have obtained any freedom to operate opinions of counsel or any Intellectual Property rights clearance searches.

“Law” means any federal, state, national, supra-national, foreign, local or municipal or other law. Statute, constitution, principle of common law, resolution, ordinance, code, edict, decree, rule, regulation, ruling or requirement issued, enacted, adopted, promulgated, implemented or otherwise put into effect by or under the authority of any Governmental Authority (including under the authority of Nasdaq or the Financial Industry Regulatory Authority).

“Legacy Asset Proceeds” means the net proceeds, if any, resulting from the Legacy Asset Disposition prior to or concurrently with the Closing.

“Legal Proceeding” means any action, suit, litigation, arbitration, proceeding (including any civil, criminal, administrative, investigative or appellate proceeding), hearing, inquiry, audit, examination or investigation commenced, brought, conducted or heard by or before, or otherwise involving, any court or other Governmental Authority or any arbitrator or arbitration panel.

“Multiemployer Plan” means a “multiemployer plan,” as defined in Section 3(37) or 4001 (a)(3) of ERISA.

 

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“Multiple Employer Plan” means a “multiple employer plan” as described in Section 413(e) of ERISA.

“Multiple Employer Welfare Arrangement” means a “multiple employer welfare arrangement” within the meaning of Section 3(40) of ERISA.

“Nasdaq” means The Nasdaq Stock Market.

“Nasdaq Reverse Split” means a reverse stock split of all outstanding shares of Homology Common Stock at a reverse stock split ratio as mutually agreed to by Homology and Q32 that is effected by Homology prior to the Effective Time.

“Notice Period” means a period of at least three (3) Business Days commencing on the date the Homology Board notifies Q32 in writing of its intent to make a Homology Board Adverse Recommendation Change.

“Order” means any judgment, order, writ, injunction, ruling, decision or decree of (that is binding on a Party), or any plea agreement, corporate integrity agreement, resolution agreement, or deferred prosecution agreement with, or any settlement under the jurisdiction of, any court or Governmental Authority.

“Ordinary Course of Business” means, in the case of each of Q32 and Homology, such actions taken in the ordinary course of its normal operations and consistent with its past practices.

“Organizational Documents” means, with respect to any Person (other than an individual), (i) the certificate or articles of association or incorporation or organization or limited partnership or limited liability company, and any joint venture, limited liability company, operating or partnership agreement and other similar documents adopted or filed in connection with the creation, formation or organization of such Person and (ii) all bylaws, regulations and similar documents or agreements relating to the organization or governance of such Person, in each case, as amended or supplemented.

“Party” or “Parties” means Q32, Homology and Merger Sub.

“Permitted Encumbrance” means (i) any statutory liens for Taxes not yet due and payable or for Taxes that are being contested in good faith and for which adequate reserves have been made on the Q32 Balance Sheet or the Homology Balance Sheet, as applicable, in accordance with GAAP, (ii) liens that have arisen in the Ordinary Course of Business and that do not (in any case or in the aggregate) materially detract from the value of the assets subject thereto or materially impair the operations of Q32 or Homology, as applicable, (iii) statutory liens to secure obligations to landlords, lessors or renters under leases or rental agreements, (iv) deposits or pledges made in connection with, or to secure payment of, workers’ compensation, unemployment insurance or similar programs mandated by Law, (v) statutory liens in favor of carriers, warehousemen, mechanics and materialmen, to secure claims for labor, materials or supplies and (vi) liens arising under applicable securities Law.

“Person” means any individual, Entity or Governmental Authority.

“Personal Information” means (i) data and information concerning an identifiable natural person, or (ii) any information that is regulated or protected by one or more Privacy Laws.

“Privacy Laws” mean Laws relating to privacy, security and/or collection, use or other processing of Personal Information.

“Q32 Associate” means any current or former employee, officer, director, independent contractor or other non-employee service provider of Q32 or any of its Subsidiaries.

“Q32 Balance Sheet” means the audited balance sheet of Q32 for the years ended December 31, 2021 and December 31, 2022.

 

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“Q32 Board” means the board of directors of Q32.

“Q32 Capital Stock” means Q32 Common Stock and Q32 Preferred Stock.

“Q32 Capitalization Representations” means the representations and warranties of Q32 set forth in Sections 3.6(a) and 3.6(d).

“Q32 Common Stock” means the common stock, $0.0001 par value per share, of Q32.

“Q32 Contract” means any Contract: (i) to which Q32 or any of its Subsidiaries is a Party, (ii) by which Q32 or any of its Subsidiaries is or may become bound or under which Q32 or any of its Subsidiaries has, or may become subject to, any obligation or (iii) under which Q32 or any of its Subsidiaries has or may acquire any right or interest.

“Q32 Convertible Notes” means the outstanding unsecured convertible promissory notes, as amended, issued by Q32 pursuant to the Q32 Note Purchase Agreement.

“Q32 Employee Plan” means any Employee Plan that Q32 or any of its Subsidiaries (i) sponsors, maintains, administers, or contributes to, or (ii) provides benefits under or through, or (iii) has any obligation to contribute to or provide benefits under or through, or (iv) may reasonably be expected to have any Liability with respect to, or (v) utilizes to provide benefits to or otherwise cover any Q32 Associate (or their spouses, dependents, or beneficiaries).

“Q32 Equity Plan” means the Q32 2017 Stock Option Plan and Grant Plan, as amended from time to time.

“Q32 Exchange Ratio” means the quotient obtained by dividing (i) the number of Q32 Merger Shares by (ii) the number of Q32 Outstanding Shares.

“Q32 Fundamental Representations” means the representations and warranties of Q32 set forth in Sections 3.1(a), 3.1(b), 3.2, 3.3, 3.4, and 3.20.

“Q32 IP Rights” means all Intellectual Property that is (i) owned by or purported to be owned, whether wholly or jointly with others, by Q32 or any of its Subsidiaries (“Q32 Owned IP Rights”), or (ii) licensed or sublicensed by Q32 or any of its Subsidiaries (“Q32 Licensed IP Rights”), in each case (i) and (ii), that is necessary for, or used or held for use in, the operation of the business of Q32 and its Subsidiaries as presently conducted.

“Q32 IP Rights Agreement” means any Contract governing, related to or pertaining to any Q32 IP Rights other than any confidential information provided under confidentiality agreements.

“Q32 Material Adverse Effect” means any Effect that, considered together with all other Effects that have occurred prior to the date of determination of the occurrence of a Q32 Material Adverse Effect, has had or would reasonably be expected to have a material adverse effect on the business, assets, liabilities, financial condition or results of operations of Q32 or its Subsidiaries, taken as a whole; provided, however, that Effects arising or resulting from the following, alone or in combination, shall not be taken into account in determining whether there has been a Q32 Material Adverse Effect: (i) the announcement of this Agreement, the pendency or the consummation of the Contemplated Transactions, including any adverse change in customer, supplier, governmental, landlord, employee or similar relationships resulting therefrom or with respect thereto (other than, in the case of this clause (i), for purposes of Section 3.3, Section 3.4, or Section 3.5), (ii) the taking of any action, or the failure to take any action, by Q32 that is expressly required under the terms of this Agreement, (iii) any natural disaster or epidemics, pandemics or other force majeure events, or any act or threat of terrorism or war, any armed hostilities or terrorist activities (including any escalation or general worsening of any of the foregoing)

 

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anywhere in the world or any governmental or other response or reaction to any of the foregoing, (iv) any change in GAAP or applicable Law or the interpretation thereof, (v) general economic, financial and capital markets, political conditions or conditions, including any instability in the banking sector, including the failure or placement into receivership of any financial institution, in each case generally affecting the industries in which Q32 and its Subsidiaries operate, (vi) any change in the cash position of Q32 and its Subsidiaries which results from operations in the Ordinary Course of Business, or (vii) any failure of Q32 to meet any projections, business plans or forecasts (provided that, this clause (vii) shall not prevent a determination that any change or effect underlying such failure to meet projections, business plans or forecasts has resulted in a Q32 Material Adverse Effect (to the extent such change or effect is not otherwise excluded from this definition of Q32 Material Adverse Effect)); except in each case with respect to clauses (iii), (iv) and (v), to the extent disproportionately affecting Q32 and its Subsidiaries, taken as a whole, relative to other similarly situated companies in the industries in which Q32 and its Subsidiaries operate.

“Q32 Merger Shares” means, subject to Section 2.4(f), the product determined by multiplying (i) the Post-Closing Homology Shares by (ii) the Q32 Allocation Percentage, in which:

 

  (i)

“Aggregate Valuation” means the sum of (A) the Q32 Equity Value, plus (B) the Homology Valuation, plus (C) the Concurrent Financing Proceeds.

 

  (ii)

“Homology Allocation Percentage” means the quotient (rounded to four decimal places) determined by dividing (A) the Homology Valuation by (B) the Aggregate Valuation.

 

  (iii)

“Homology Equity Value” means $80,000,000.

 

  (iv)

“Homology Outstanding Shares” means, subject to Section 2.4(f) (including, without limitation, the effects of the Nasdaq Reverse Split), the total number of shares of Homology Common Stock outstanding immediately prior to the Effective Time expressed on a fully-diluted basis, and assuming, without limitation or duplication, (A) the issuance of shares of Homology Common Stock in respect of all Homology ITM Options that will be outstanding as of immediately prior to the Effective Time calculated on a “treasury method” basis, (B) the settlement in shares of Homology Common Stock of Homology Restricted Stock Units outstanding as of immediately prior to the Effective Time on a net settlement basis as provided in Section 5.13 and (C) the exclusion of shares of Homology Common Stock held by Homology as treasury stock or owned by Q32 or any of its Subsidiaries or any Subsidiary of Homology immediately prior to the Effective Time.

 

  (v)

“Homology Valuation” means (A) the Homology Equity Value minus (B) the Homology Net Cash Deficiency (if any) plus (C) the Homology Net Cash Surplus (if any).

 

  (vi)

“Q32 Allocation Percentage” means the quotient (rounded to four decimal places) determined by dividing (A) the Q32 Equity Value by (B) the Aggregate Valuation.

 

  (vii)

“Q32 Equity Value” means $195,000,000.

 

  (viii)

“Homology Net Cash Deficiency” means, if Homology Net Cash is less than $59,500,000, then the amount, if any, that $60,000,000 exceeds the Homology Net Cash, calculated as of 12:01 am Eastern time on the Closing Date; provided, however, any such calculation with respect to Taxes shall be calculated as of the end of the Closing Date.

 

  (ix)

“Post-Closing Homology Shares” mean the quotient determined by dividing (A) the Homology Outstanding Shares by (B) the Homology Allocation Percentage.

 

  (x)

“Homology Net Cash Surplus” means, if Homology Net Cash is greater than $60,500,000, then the amount, if any, that the Homology Net Cash exceeds $60,000,000, calculated as of 12:01 am Eastern time on the Closing Date; provided, however, any such calculation with respect to Taxes shall be calculated as of the end of the Closing Date.

For the avoidance of doubt, the Concurrent Financing Proceeds shall not be included in the calculation or determination of the Homology Valuation or any component thereof. Set forth on Section 1.1(a)(ii) on the

 

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Homology Disclosure Schedule is an illustrative example of the calculation of the Q32 Merger Shares calculation.

“Q32 Note Purchase Agreement” means the Note Purchase Agreement, by and among Q32 and the other parties thereto, dated as of May 20, 2022, as may be amended or supplemented from time to time.

“Q32 Outstanding Shares” means, the total number of shares of Q32 Common Stock outstanding immediately prior to the Effective Time (after giving effect to the Q32 Preferred Stock Conversion and the conversion of the Q32 Convertible Notes) expressed on a fully-diluted and as-converted to Q32 Common Stock on a “treasury method” basis and assuming, without limitation or duplication, the issuance of all shares of Q32 Common Stock that would be issued assuming the acceleration and exercise and conversion of all Q32 Options and Q32 Warrants outstanding as of immediately prior to the Effective Time.

“Q32 Options” means options to purchase shares of Q32 Common Stock granted by Q32 under the Q32 Equity Plan.

“Q32 Preferred Stock” means, collectively, the Series A Preferred Stock, Series A1 Preferred Stock and Series B Preferred Stock,

“Q32 Registered IP” means all Q32 IP Rights that are owned or exclusively licensed by Q32 or any of its Subsidiaries that are registered, filed, issued or otherwise granted under the authority of, with or by any Governmental Authority, including all patents, registered copyrights and registered trademarks and all applications and registrations for any of the foregoing.

“Q32 Series A1 Preferred Stock” means the preferred stock, $0.0001 par value per share, of Q32, designated as Series A1 Preferred Stock.

“Q32 Series A Preferred Stock” means the preferred stock, $0.0001 par value per share, of Q32, designated as Series A Preferred Stock.

“Q32 Series B Preferred Stock” means the preferred stock, $0.0001 par value per share, of Q32, designated as Series B Preferred Stock.

“Q32 Triggering Event” shall be deemed to have occurred if: (i) Q32 Board or any committee thereof shall have approved, endorsed or recommended any Acquisition Proposal or (ii) Q32 shall have entered into any letter of intent or similar document or any Contract relating to any Acquisition Proposal (other than an Acceptable Confidentiality Agreement as pursuant to Section 5.4).

“Q32 Warrants” means options to purchase shares of Q32 Common Stock issued under the Warrant Agreements.

“Representatives” means, with respect to any Person, such Person’s directors, officers, employees, agents, attorneys, accountants, investment bankers, advisors and representatives.

“Sarbanes-Oxley Act” means the Sarbanes-Oxley Act of 2002.

“SEC” means the United States Securities and Exchange Commission.

“Securities Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.

 

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“Subsequent Transaction” means any Acquisition Transaction (with all references to 20% in the definition of Acquisition Transaction being treated as references to 50% for these purposes).

“Subsidiary” means, with respect to a Person, an Entity of which more than 50% of the voting power of the equity securities or equity interests is owned, directly or indirectly, by such Person.

“Superior Offer” means an unsolicited bona fide written Acquisition Proposal (with all references to 20% in the definition of Acquisition Transaction being treated as references to 50% for these purposes) that: (i) was not obtained or made as a direct or indirect result of a breach of (or in violation of) this Agreement and (ii) is on terms and conditions that the Q32 Board or the Homology Board, as applicable, determines in good faith, based on such matters that it deems relevant (including the likelihood of consummation thereof and the financing terms and any termination or break-up fees and conditions to consummation thereof), as well as any written offer by the other Party to this Agreement to amend the terms of this Agreement, and following consultation with its outside legal counsel and financial advisors, if any, are more favorable, from a financial point of view, to Q32’s stockholders or Homology’s stockholders, as applicable, than the terms of the Contemplated Transactions and is not subject to any financing conditions (and if financing is required, such financing is then fully committed to the third party).

“Tax” means (i) any U.S. federal, state or local or non-U.S. tax, including any income tax, franchise tax, capital gains tax, gross receipts tax, value-added tax, surtax, estimated tax, unemployment tax, excise tax, ad valorem tax, transfer tax, stamp tax, sales tax, use tax, property tax, business tax, withholding tax, imputed underpayment amount, payroll tax, customs duty, escheat, unclaimed property, alternative or add-on minimum or other tax or similar charge (whether imposed directly or through withholding and whether or not disputed), and including any fine, penalty, addition to tax, interest or additional amount imposed by a Governmental Authority with respect thereto (or attributable to the nonpayment thereof) and (ii) any liability for payment of amounts described in clause (i) whether as a result of transferee or successor liability, of being a member of an affiliated, consolidated, combined or unitary group for any period, pursuant to a Contract, through operation of Law or otherwise.

“Tax Return” means any return (including any information return), report, statement, declaration, claim or refund, estimate, schedule, notice, notification, form, election, certificate or other document or information, and any amendment or supplement to any of the foregoing, filed or required to be filed with any Governmental Authority (or provided to a payee) in connection with the determination, assessment, collection or payment of any Tax or in connection with the administration, implementation or enforcement of or compliance with any Law relating to any Tax.

“Transaction Expenses” means, with respect to a Party, the aggregate amount (without duplication) of all costs, fees, and expenses incurred by such Party or any of its Subsidiaries (including Merger Sub), or for which such Party or any of its Subsidiaries are or may become liable in connection with the Contemplated Transactions and the negotiation, preparation and execution of this Agreement or any other agreement, document, instrument, filing, certificate, schedule, exhibit, letter or other document prepared or executed in connection with the Contemplated Transactions, including (i) any fees and expenses of legal counsel and accountants, the maximum amount of fees and expenses payable to financial advisors, investment bankers, brokers, consultants, tax advisors, transfer agents, proxy solicitor and other advisors of such Party; (ii) the premiums, commissions and other fees paid or payable in connection with obtaining Homology’s D&O tail policy as set forth in Section 5.15(d); (iii) the premiums, commissions and other fees paid or payable in connection with obtaining Homology’s Clinical Trial Insurance tail policy; and (iv) the CVR Fees.

“Treasury Regulations” means the United States Treasury regulations promulgated under the Code.

“WARN Act” means the Worker Adjustment and Retraining Notification Act of 1988, as amended, and any similar or related law.

 

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“Warrant Agreements” means that certain (i) Warrant to Purchase Common Stock, by and between Q32 Bio Inc. and Silicon Valley Bank, issued on December 11, 2020 for 166,371 shares of Q32 Common Stock at an exercise price of $0.33 per share (subject to adjustments) and (ii) Warrant to Purchase Common Stock, by and between Q32 Bio Inc. and Silicon Valley Bank, issued on July 12, 2023 for 211,528 shares of Q32 Common Stock at an exercise price of $0.36 per share (subject to adjustments).

(ii) Each of the following terms is defined in the Section set forth opposite such term:

 

Term

  

Section

Abandoned Homology Legacy IP Rights

   5.2

Accounting Firm

   2.8(e)

Agreement

   Preamble

Allocation Certificate

   5.22

Anticipated Closing Date

   2.8(a)

Assumed Option

   2.4(g)

Assumed Option

   2.4(i)

Authorized Share Increase Proposal

   Recitals

Cash Determination Time

   2.8(a)

Capitalization Date

   4.6(a)

Certificate of Merger

   2.1

Charter Amendment Proposals

   Recitals

Closing

   2.2

Closing Date

   2.2

Code

   Recitals

Costs

   5.15(a)

Current Offering Period

   5.15(a)

CVR

   2.5(a)

CVR Agreement

   2.5(a)

CVR Fees

   2.5(b)

D&O Indemnified Parties

   5.15(a)

D&O tail policy

   5.15(d)

Delivery Date

   2.8(a)

Dispute Notice

   2.8(b)

Disqualifying Event

   4.22

Drug Regulatory Agency

   3.14(c)

Effective Time

   2.1

Exchange Agent

   2.7(a)

FDA

   3.14(c)

FDCA

   3.14(c)

Final Homology Net Cash

   2.8(c)

Form S-4

   5.7(a)

Homology

   Preamble

Homology Board

   Recitals

Homology Board Adverse Recommendation Change

   5.9(b)

Homology Board Recommendation

   5.9(b)

Homology Certifications

   4.7(a)

Homology Closing Certificate

   6.2(d)

Homology Common Stock

   4.6(a)

Homology Designee

   5.19(a)(i)

Homology Disclosure Schedule

   Article IV

Homology IT Systems

   4.23(b)

Homology Lease Agreement

   5.5(b)

 

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Term

  

Section

Homology Lock-Up Agreements

   Recitals

Homology Material Contract

   4.13(a)

Homology Net Cash Calculation

   2.8(a)

Homology Net Cash Schedule

   2.8(a)

Homology Permits

   4.14(b)

Homology Preferred Stock

   4.6(a)

Homology Product Candidates

   4.14(d)

Homology Regulatory Permits

   4.14(d)

Homology Real Estate Leases

   4.11

Homology Stockholder Matters

   5.9(a)

Homology Stockholder Meeting

   5.9(a)

Homology Stockholder Support Agreement

   Recitals

Information Statement

   5.8(a)

Intended Tax Treatment

   Recitals

Legacy Assets

   0

Legacy Asset Disposition

   0

Liability

   3.9

Merger

   Recitals

Merger Sub

   Preamble

Merger Sub Board

   Recitals

Nasdaq Issuance Proposal

   Recitals

Ordinary Course Agreement

   3.16(f)

Outside Date

   8.1(b)

PHSA

   3.14(c)

Pre-Closing Distribution

   2.5(a)

Pre-Closing Period

   5.1

Privacy Policies

   3.22(a)

Proxy Statement

   5.7(a)

Q32

   Preamble

Q32 Board Recommendation

   5.8(c)

Q32 Certification

   3.7(a)

Q32 Closing Certificate

   6.3(d)

Q32 Designee

   5.19(a)(i)

Q32 Disclosure Schedule

   Article III

Q32 Financial Statements

   3.7(a)

Q32 IT Systems

   3.22(b)

Q32 Lock-Up Agreements

   Recitals

Q32 Material Contract

   3.13(a)

Q32 Permits

   3.14(b)

Q32 Preferred Stock Conversion

   2.4(h)

Q32 Product Candidates

   3.14(d)

Q32 Real Estate Leases

   3.11

Q32 Regulatory Permits

   3.14(d)

Q32 Stockholder Support Agreement

   Recitals

Q32 Stockholder Written Consents

   Recitals

Registration Statement

   5.7(a)

Required Homology Stockholder Vote

   4.4

Required Q32 Stockholder Vote

   3.4

Response Date

   2.8(b)

Reverse Stock Split Proposal

   Recitals
RSU Withholding Amount    5.13

 

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Term

  

Section

Subscription Agreement    Recitals
Surviving Corporation    2.1
Transfer Tax    5.16(a)

1.2 Other Definitional and Interpretative Provisions. The words “hereof,” “herein” and “hereunder” and words of like import used in this Agreement shall refer to this Agreement as a whole and not to any particular provision of this Agreement. The captions herein are included for convenience of reference only and shall be ignored in the construction or interpretation hereof. References to Sections, Exhibits and Schedules are to Sections, Exhibits and Schedules of this Agreement unless otherwise specified. Any capitalized terms used in any Exhibit or Schedule but not otherwise defined therein shall have the meaning as defined in this Agreement. Any singular term in this Agreement shall be deemed to include the plural, and any plural term the singular, the masculine gender shall include the feminine and neuter genders; the feminine gender shall include the masculine and neuter genders; and the neuter gender shall include masculine and feminine gender. Whenever the words “include,” “includes” or “including” are used in this Agreement, they shall be deemed to be followed by the words “without limitation,” whether or not they are in fact followed by those words or words of like import. The word “or” is not exclusive. “Writing,” “written” and comparable terms refer to printing, typing and other means of reproducing words (including electronic media) in a visible form. References to any agreement or Contract are to that agreement or Contract as amended, modified or supplemented from time to time in accordance with the terms hereof and thereof. References to any Person include the successors and permitted assigns of that Person. References to any statute are to that statute and to the rules and regulations promulgated thereunder, in each case as amended, modified, re-enacted thereof, substituted, from time to time. References to “$” and “dollars” are to the currency of the United States. All accounting terms used herein will be interpreted, and all accounting determinations hereunder will be made, in accordance with GAAP unless otherwise expressly specified. References from or through any date shall mean, unless otherwise specified, from and including or through and including, respectively. All references to “days” shall be to calendar days unless otherwise indicated as a “Business Day.” Except as otherwise specifically indicated, for purposes of measuring the beginning and ending of time periods in this Agreement (including for purposes of “Business Day” and for hours in a day or Business Day), the time at which a thing, occurrence or event shall begin or end shall be deemed to occur in the Eastern time zone of the United States. The Parties agree that any rule of construction to the effect that ambiguities are to be resolved against the drafting Party shall not be applied in the construction or interpretation of this Agreement. The Parties agree that the Q32 Disclosure Schedule or the Homology Disclosure Schedule shall be arranged in sections and subsections corresponding to the numbered and lettered sections and subsections contained in Article III or Article IV respectively. The disclosures in any section or subsection of the Q32 Disclosure Schedule or the Homology Disclosure Schedule shall qualify other sections and subsections in Article III or Article IV respectively, to the extent it is readily apparent from a reading of the disclosure that such disclosure is applicable to such other sections and subsections. The words “delivered” or “made available” mean, with respect to any documentation, (a) that prior to 5:00 p.m. (New York City time) on the date that is the day prior to the date of this Agreement, a copy of such material has been posted to and made available by a Party to the other Party and its Representatives in the electronic data room maintained by such disclosing Party for the purposes of the Contemplated Transactions or (b) delivered by or on behalf of a Party or its Representatives to the other Party or its Representatives via electronic mail prior to the execution of this Agreement. The inclusion of any information in the Q32 Disclosure Schedule or Homology Disclosure Schedule (or any update thereto) shall not be deemed to be an admission or acknowledgement, in and of itself, that such information is required by the terms hereof to be disclosed, is material, has resulted in or would result in a Q32 Material Adverse Effect or Homology Material Adverse Effect, as the case may be, or is outside the Ordinary Course of Business.

 

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ARTICLE II

THE MERGER

2.1 The Merger. Upon the terms and subject to the conditions set forth in this Agreement and subject to the applicable provisions of Delaware Law, at the Closing, Homology and Q32 shall cause Merger Sub to be merged with and into Q32, whereupon the separate existence of Merger Sub shall cease and Q32 shall continue as the Surviving Corporation of the Merger and as a wholly owned subsidiary of Homology (the “Surviving Corporation”). At the Closing, Homology and Q32 shall cause the Merger to be consummated and effective under Delaware Law by executing and filing with the Secretary of State of the State of Delaware a certificate of merger, satisfying the applicable requirements of Delaware Law in a form to be mutually agreed by the Parties prior to the Closing (the “Certificate of Merger”). The Merger shall become effective at the time of the filing of such Certificate of Merger and the acceptance by the Secretary of State of the State of Delaware, or at such later time as may be specified in such Certificate of Merger with the consent of Homology and Q32 (the time as of which the Merger becomes effective being referred to as the “Effective Time”).

2.2 Closing. Subject to the satisfaction or waiver of the conditions set forth in this Agreement, the consummation of the Merger (the “Closing”) shall take place remotely, (a) no later than the second (2nd) Business Day after all the conditions precedent set forth in Article VI shall have been satisfied or waived (other than those conditions that, by their nature, are to be satisfied at the Closing (provided such conditions would be so satisfied)) or (b) at such other time, date and place as the Parties may mutually agree in writing. The date on which the Closing actually takes place is referred to as the “Closing Date”.

2.3 Organizational Documents; Directors and Officers.

(a) Certificate of Incorporation. The certificate of incorporation of the Surviving Corporation shall be amended and restated at or prior to the Effective Time as set forth in an exhibit to the Certificate of Merger, and as so amended and restated shall be the certificate of incorporation of the Surviving Corporation until thereafter amended as provided by Delaware Law. Homology shall further take all actions necessary so that the certificate of incorporation of Homology shall remain in effect following the Effective Time, until thereafter amended as provided by Delaware Law, provided, however, that at or prior to the Effective Time, Homology shall file one or more amendments to its certificate of incorporation to (i) change the name of Homology to Q32 Bio Inc., (ii) effect the Nasdaq Reverse Split and the Authorized Share Increase Proposal and (iii) make such other changes as are mutually agreeable to Homology and Q32.

(b) Bylaws. The bylaws of the Surviving Corporation shall be amended and restated as of the Effective Time to be the same as the bylaws of Merger Sub as in effect immediately prior to the Effective Time (with the name of Q32 as the Surviving Corporation’s name) until thereafter amended in accordance with Delaware Law and as provided in the Surviving Corporation’s Organizational Documents.

(c) Directors and Officers. The directors and officers, each to hold office in accordance with the provisions of Delaware Law and the Surviving Corporation’s Organizational Documents immediately after the Effective Time, shall be as set forth in Section 5.19.

2.4 Conversion of Shares.

(a) At the Effective Time (after giving effect to Q32 Preferred Stock Conversion), by virtue of the Merger and without any further action on the part of Homology, Merger Sub, Q32 or any stockholder of Q32, subject to Section 2.4(d), the Q32 Common Stock outstanding immediately prior to the Effective Time (excluding Q32 Common Stock issued in the Concurrent Financing) shall be converted solely into the right to receive a number of shares of Homology Common Stock equal to the amount of Q32 Merger Shares multiplied by the applicable stockholder’s percentage interest in Q32 as set forth on the Allocation Certificate.

 

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(b) At the Effective Time, by virtue of the Merger and without further action on the part of Homology, Merger Sub, Q32 or any stockholder of Q32, subject to Section 2.4(d), the Q32 Common Stock issued in the Concurrent Financing shall be converted solely into the right to receive a number of shares of Homology Common Stock equal to the amount of Concurrent Financing Merger Shares multiplied by the percentage of the Concurrent Financing Proceeds represented by the applicable stockholder’s investment in the Concurrent Financing, as set forth on the Allocation Certificate.

(c) If any Q32 Common Stock outstanding immediately prior to the Effective Time is unvested or is subject to a repurchase option or a risk of forfeiture under any applicable restricted stock, restricted stock unit award agreement or other similar agreement with Q32, then the shares of Homology Common Stock issued in exchange for such Q32 Common Stock will to the same extent be unvested and subject to the same repurchase option or risk of forfeiture, and such shares of Homology Common Stock shall accordingly be marked with appropriate legends. Q32 shall take all actions that may be necessary to ensure that, from and after the Effective Time, Homology is entitled to exercise any such repurchase option or other right set forth in any such restricted stock unit award agreement or other agreement.

(d) No fractional shares of Homology Common Stock shall be issued in connection with the Merger, and no certificates or scrip for any such fractional shares shall be issued, with no cash being paid for any fractional share eliminated by such rounding. Any fractional shares of Homology Common Stock a holder of Q32 Common Stock would otherwise be entitled to receive shall be aggregated together first prior to eliminating any remaining fractional share.

(e) At the Effective Time, by virtue of the Merger and without any further action on the part of Homology, Merger Sub, Q32 or any stockholder of Q32, each share of common stock, $0.01 par value per share, of Merger Sub issued and outstanding immediately prior to the Effective Time shall be converted into and exchanged for one validly issued, fully paid and nonassessable share of common stock, $0.0001 par value per share, of the Surviving Corporation. If applicable, each stock certificate of Merger Sub evidencing ownership of any such shares shall, as of the Effective Time, evidence ownership of such shares of common stock of the Surviving Corporation until presented for transfer or exchange.

(f) If, between the date of this Agreement and the Effective Time, the outstanding Q32 Common Stock or Homology Common Stock shall have been changed into, or exchanged for, a different number of shares or a different class, by reason of any stock dividend, subdivision, reclassification, recapitalization, split (including the Nasdaq Reverse Split to the extent such split has not previously been taken into account in calculating Q32 Merger Shares), combination or exchange of shares or other like change, Q32 Merger Shares shall, to the extent necessary, be equitably adjusted to reflect such change to the extent necessary to provide the holders of Q32 Common Stock and Homology Common Stock with the same economic effect as contemplated by this Agreement prior to such stock dividend, subdivision, reclassification, recapitalization, split, combination or exchange of shares or other like change; provided, however, that nothing herein will be construed to permit Q32 or Homology to take any action with respect to Q32 Common Stock or Homology Common Stock, respectively, that is prohibited or not expressly permitted by the terms of this Agreement.

(g) Each Q32 Option outstanding immediately prior to the Effective Time shall automatically without any further action on the part of Homology, Merger Sub, Q32 or any holder of a Q32 Option, be converted, at the Effective Time, into an option (an “Assumed Option”) to acquire, on the same terms and conditions (including the same vesting and exercisability terms and conditions) as were applicable under the Q32 Equity Plan and option agreement applicable to such Q32 Option immediately prior to the Effective Time, the number of shares of Homology Common Stock determined by multiplying the number of shares of Q32 Common Stock subject to such Q32 Option immediately prior to the Effective Time by the Q32 Exchange Ratio, rounding down to the nearest whole number of shares, at a per share exercise price determined by dividing the per share exercise price of such Q32 Option immediately prior to the Effective Time by the Q32 Exchange Ratio, rounding up to the nearest whole cent; provided, that the conversion of the Q32 Options will be made in a manner consistent with

 

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Treasury Regulations Section 1.424-1, such that the conversion will not constitute a “modification” of such Q32 Options for purposes of Section 409A or Section 424 of the Code. As of the Effective Time, Homology will assume the Q32 Equity Plan.

(h) All Q32 Preferred Stock shall be converted into Q32 Common Stock as of immediately prior to the Effective Time in accordance with, and pursuant to the terms and conditions of, the Organizational Documents of Q32 (the “Q32 Preferred Stock Conversion”).

(i) At the Effective Time, each Q32 Warrant, to the extent outstanding and unexercised, shall automatically, without any action on the part of the holder thereof, be converted into a warrant to acquire a number of shares of Homology Common Stock(each such resulting warrant, an “Assumed Warrant”). Each Assumed Warrant shall be subject to the same terms and conditions as were applicable to such corresponding Q32 Warrant immediately prior to the Effective Time (including applicable vesting conditions), except (i) each Assumed Warrant will be exercisable (or will become exercisable in accordance with its terms) for that number of whole shares of Homology Common Stock equal to the product of the number of Q32 Merger Shares that were issuable upon exercise of such Q32 Warrant immediately prior to the Effective Time multiplied by the Q32 Exchange Ratio, rounded down to the nearest whole number of shares of Homology Common Stock, (ii) the per share exercise price for the shares of Homology Common Stock issuable upon exercise of such Assumed Warrant will be equal to the quotient determined by dividing the exercise price per share of Q32 Common Stock at which such Q32 Warrant was exercisable immediately prior to the Effective Time by the Q32 Exchange Ratio, rounded up to the nearest whole cent, and (iii) for terms rendered inoperative by reason of the transactions contemplated by this Agreement (including any anti-dilution or other similar provisions that adjust the number of underlying shares that could become exercisable subject to such Q32 Warrant).

(j) Immediately prior to the Effective Time, the Company shall cause the outstanding principal and accrued but unpaid interest on Q32 Convertible Notes to be converted into the applicable number of shares of Q32 Common Stock provided for under the terms of such Q32 Convertible Note (the “Convertible Notes Conversion”). All of Q32 Convertible Notes converted into shares of Q32 Common Stock shall no longer be outstanding and shall cease to exist, and each holder of Q32 Convertible Notes shall thereafter cease to have any rights with respect to Q32 Convertible Notes. Immediately following the Convertible Notes Conversion, at the Effective Time and by virtue of the Merger, all shares of Q32 Common Stock issued in the Convertible Notes Conversion shall be canceled and converted into the right to receive Homology Common Stock pursuant to this Section 2.4.

2.5 Contingent Value Right.

(a) Prior to the Effective Time, Homology shall declare a distribution (the “Pre-Closing Distribution”) to holders of Homology Common Stock of record the right to receive one contingent value right (each, a “CVR”) for each outstanding share of Homology Common Stock held by such stockholder as of such date, each representing the right to receive contingent payments upon the occurrence of certain events set forth in, and subject to and in accordance with the terms and conditions of, the Contingent Value Rights Agreement in the form attached hereto as Exhibit E, to be entered into between Homology and Equiniti Trust Company, LLC (or such other nationally recognized rights agent agreed to between Homology and Q32) (the “Rights Agent”), with such revisions thereto requested by the Rights Agent that are not, individually or in the aggregate, materially detrimental to the holders of CVRs and reasonably acceptable to Homology and Q32 (the “CVR Agreement”). The record date for the Pre-Closing Distribution shall be the close of business on the last Business Day prior to the day on which the Effective Time occurs and the payment date for the Pre-Closing Distribution shall be three (3) Business Days after the Effective Time; provided that the payment of such distribution may be conditioned upon the occurrence of the Effective Time. In connection with the Pre-Closing Distribution, Homology shall cause the CVR Agreement to be duly authorized, executed and delivered by Homology and the Exchange Agent.

(b) Homology agrees to pay all reasonable costs and fees associated with any action contemplated by this Section 2.5 (the “CVR Fees”).

 

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2.6 Closing of Q32’s Transfer Books. At the Effective Time: (a) all Q32 Common Stock outstanding immediately prior to the Effective Time shall be treated in accordance with Section 2.4(a) and Section 2.4(b), as applicable, and all holders of certificates representing Q32 Common Stock that were outstanding immediately prior to the Effective Time shall cease to have any rights as stockholders of Q32 (other than the right to receive Q32 Merger Shares) and (b) the stock transfer books of Q32 shall be closed with respect to all Q32 Common Stock outstanding immediately prior to the Effective Time. No further transfer of any such Q32 Common Stock shall be made on such stock transfer books after the Effective Time.

2.7 Surrender of Q32 Common Stock.

(a) On or prior to the Closing Date, Homology and Q32 shall jointly select a reputable bank, transfer agent or trust company to act as exchange agent in the Merger (the “Exchange Agent”). At the Effective Time, Homology shall deposit with the Exchange Agent evidence of book-entry shares representing the shares of Homology Common Stock issuable pursuant to Section 2.4(a) in exchange for Q32 Common Stock.

(b) Promptly after the Effective Time, the Parties shall cause the Exchange Agent to mail to the Persons who were record holders of Q32 Common Stock that were converted into the right to receive Q32 Merger Shares: (i) a letter of transmittal in customary form and containing such provisions as Homology may reasonably specify and (ii) instructions for effecting the surrender of Q32 Common Stock in exchange for book-entry shares of Homology Common Stock. Upon surrender of a duly executed letter of transmittal and such other documents as may be reasonably required by the Exchange Agent or Homology, the holder of such Q32 Common Stock shall be entitled to receive in exchange therefor book-entry shares representing Q32 Merger Shares (in a number of whole shares of Homology Common Stock) that such holder has the right to receive pursuant to the provisions of Section 2.4(a).

(c) No dividends or other distributions declared or made with respect to Homology Common Stock with a record date after the Effective Time shall be paid to the holder of any Q32 Common Stock with respect to the shares of Homology Common Stock that such holder has the right to receive in the Merger until such holder delivers a duly executed letter of transmittal (at which time (or, if later, on the applicable payment date) such holder shall be entitled, subject to the effect of applicable abandoned property, escheat or similar Laws, to receive all such dividends and distributions, without interest).

(d) Any shares of Homology Common Stock deposited with the Exchange Agent that remain undistributed to holders of Q32 Common Stock as of the date that is 180 days after the Closing Date shall be delivered to Homology upon demand, and any holders of Q32 Common Stock who have not theretofore delivered a duly executed letter of transmittal in accordance with this Section 2.7 shall thereafter look only to Homology for satisfaction of their claims for Homology Common Stock and any dividends or distributions with respect to shares of Homology Common Stock.

(e) No Party shall be liable to any holder of any Q32 Common Stock or to any other Person with respect to any shares of Homology Common Stock (or dividends or distributions with respect thereto) or for any cash amounts delivered to any public official pursuant to any applicable abandoned property Law, escheat Law or similar Law.

2.8 Calculation of Net Cash.

(a) Not less than ten (10) Business Days prior to the anticipated date for Closing as mutually agreed in good faith by Homology and Q32 (the “Anticipated Closing Date”), Homology will deliver to Q32 a schedule (the “Homology Net Cash Schedule”, and the date of delivery of the Homology Net Cash Schedule, the “Delivery Date”) setting forth, in reasonable detail, Homology’s good faith, estimated calculation of Homology Net Cash (the “Homology Net Cash Calculation”) as of the close of business on the Closing Date (the “Cash Determination Time”) prepared and certified by Homology’s chief financial officer (or if there is no chief

 

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financial officer at such time, the principal financial and accounting officer for Homology). Homology shall make available to Q32 (electronically to the greatest extent possible), as reasonably requested by Q32, the work papers and back-up materials used or useful in preparing the Homology Net Cash Schedule and, if reasonably requested by Q32, Homology’s accountants and counsel at reasonable times and upon reasonable notice. The Homology Net Cash Calculation shall include Homology’s determination, as of the Cash Determination Time, of the defined terms in Section 1.1 necessary to calculate Q32 Merger Shares. Set forth on Section 2.8(a) of the Homology Disclosure Schedule is an illustrative example of Homology Net Cash calculation calculated on a hypothetical basis as of the date described therein.

(b) Within five (5) Business Days after the Delivery Date (the last day of such period, the “Response Date”), Q32 shall have the right to dispute any part of the Homology Net Cash Calculation by delivering a written notice to that effect to Homology (a “Dispute Notice”). Any Dispute Notice shall identify in reasonable detail and to the extent known the nature and amounts of any proposed revisions to the Homology Net Cash Calculation.

(c) If, on or prior to the Response Date, Q32 notifies Homology in writing that it has no objections to the Homology Net Cash Calculation or, if prior to 5:00 p.m. (New York City time) on the Response Date, Q32 has failed to deliver a Dispute Notice as provided in Section 2.8(b), then the Homology Net Cash Calculation as set forth in the Homology Net Cash Schedule shall be deemed to have been finally determined for purposes of this Agreement and to represent the Homology Net Cash at the Cash Determination Time (the “Final Homology Net Cash”) for purposes of this Agreement.

(d) If Q32 delivers a Dispute Notice on or prior to 5:00 p.m. (New York City time) on the Response Date, then Representatives of Homology and Q32 shall promptly, and in no event later than one calendar day after the Response Date, meet and attempt in good faith to resolve the disputed item(s) and negotiate an agreed-upon determination of Homology Net Cash, which agreed upon Homology Net Cash amount shall be deemed to have been finally determined for purposes of this Agreement and to represent the Final Homology Net Cash for purposes of this Agreement.

(e) If Representatives of Homology and Q32 are unable to negotiate an agreed-upon determination of Final Net Cash pursuant to Section 2.8(d) within two (2) calendar days after delivery of the Dispute Notice (or such other period as Homology and Q32 may mutually agree upon), then any remaining disagreements as to the calculation of Homology Net Cash shall be referred to an independent auditor of recognized national standing jointly selected by Homology and Q32 or another independent auditor of recognized national standing mutually agreed upon by Homology and Q32 (the “Accounting Firm”). Homology shall promptly deliver to the Accounting Firm all work papers and back-up materials used in preparing the Homology Net Cash Schedule, and Homology and Q32 shall use commercially reasonable efforts to cause the Accounting Firm to make its determination within five (5) calendar days of accepting its selection. Homology and Q32 shall be afforded the opportunity to present to the Accounting Firm any material related to the unresolved disputes and to discuss the issues with the Accounting Firm; provided, however, that no such presentation or discussion shall occur without the presence of a Representative of each of Homology and Q32. The determination of the Accounting Firm shall be limited to the disagreements submitted to the Accounting Firm. The determination of the amount of Homology Net Cash made by the Accounting Firm shall be made in writing delivered to each of Homology and Q32, shall be final and binding on Homology and Q32 and shall be deemed to have been finally determined for purposes of this Agreement and to represent the Final Homology Net Cash for purposes of this Agreement. The Parties shall delay the Closing until the resolution of the matters described in this Section 2.8(e). The fees and expenses of the Accounting Firm shall be allocated between Homology and Q32 in the same proportion that the disputed amount of the Homology Net Cash that was unsuccessfully disputed by such Party (as finally determined by the Accounting Firm) bears to the total disputed amount of the Homology Net Cash amount and such portion of the costs and expenses of the Accounting Firm borne by Q32 and any other fees, costs or expenses incurred by Q32 following the Anticipated Closing Date in connection with the procedures set forth in this Section 2.8(e) shall be deducted from the final determination of the amount of Homology Net Cash. If this

 

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Section 2.8(e) applies as to the determination of the Final Homology Net Cash described in Section 2.8(a), upon resolution of the matter in accordance with this Section 2.8(e), the Parties shall not be required to determine Homology Net Cash again even though the Closing Date may occur later than the Anticipated Closing Date, except that either Homology and Q32 may require a redetermination of the Final Homology Net Cash if the Closing Date is more than ten (10) calendar days after the Anticipated Closing Date.

2.9 Further Action. If, at any time after the Effective Time, any further action is determined by the Surviving Corporation to be necessary or desirable to carry out the purposes of this Agreement or to vest the Surviving Corporation with full right, title and possession of and to all rights and property of Q32, then the officers and manager of the Surviving Corporation shall be fully authorized, and shall use their and its commercially reasonable efforts (in the name of Q32, in the name of Merger Sub, in the name of the Surviving Corporation and otherwise) to take such action.

2.10 Withholding. Each of the Exchange Agent, Homology and the Surviving Corporation (each, a “Withholding Agent”) shall be entitled to deduct and withhold from any consideration deliverable pursuant to this Agreement (including the Pre-Closing Distribution) such amounts as are required to be deducted or withheld from such consideration under the Code or under any other applicable Law; provided, however, that if a Withholding Agent determines that any payment in connection with the Contemplated Transactions is subject to deduction and/or withholding, then, except with respect to compensatory payments or as a result of a failure to deliver the certificate described in Section 5.16(b), such Withholding Agent shall use commercially reasonable efforts to (i) provide reasonable advance notice to such recipient of any required deduction or withholding and (ii) reasonably cooperate with such recipient to reduce or eliminate any such deduction and/or withholding. To the extent such amounts are so deducted or withheld, such amounts shall be (i) timely remitted to the appropriate Governmental Authority and (ii) treated for all purposes under this Agreement as having been paid to the Person to whom such amounts would otherwise have been paid.

ARTICLE III

REPRESENTATIONS AND WARRANTIES OF Q32

Except as set forth in the written disclosure schedule delivered by Q32 to Homology (the “Q32 Disclosure Schedule”), Q32 represents and warrants to Homology and Merger Sub as follows:

3.1 Due Organization; Subsidiaries.

(a) Q32 is a corporation or other legal entity duly incorporated or otherwise organized, validly existing and in good standing under the Laws of the jurisdiction of its incorporation or organization and has all necessary power and authority: (i) to conduct its business in the manner in which its business is currently being conducted, (ii) to own or lease and use its property and assets in the manner in which its property and assets are currently owned or leased and used and (iii) to perform its obligations under all Contracts by which it is bound.

(b) Each of Q32 and its Subsidiaries is licensed and qualified to do business, and is in good standing (to the extent applicable in such jurisdiction), under the Laws of all jurisdictions where the nature of its business in the manner in which its business is currently being conducted requires such licensing or qualification other than in jurisdictions where the failure to be so qualified individually or in the aggregate would not be reasonably expected to have a Q32 Material Adverse Effect.

(c) Except as set forth on Section 3.1(c) of the Q32 Disclosure Schedule, Q32 has no Subsidiaries and Q32 does not directly or indirectly own any capital stock of, or any equity ownership or profit sharing interest of any nature in, or control directly or indirectly, any other Entity. Q32 is not and has not otherwise been, directly or indirectly, a party to, member of or participant in any partnership, joint venture or similar business entity. Q32

 

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has not agreed and is not obligated to make, or is bound by any Contract under which it may become obligated to make, any future investment in or capital contribution to any other Entity. Q32 has not, at any time, been a general partner of, and has not otherwise been liable for any of the debts or other obligations of, any general partnership, limited partnership or other Entity.

3.2 Organizational Documents. Q32 has delivered to Homology accurate and complete copies of Q32’s Organizational Documents. Q32 is not in breach or violation of its Organizational Documents in any material respect.

3.3 Authority; Binding Nature of Agreement. Q32 has all necessary corporate power and authority to enter into and to perform its obligations under this Agreement and to consummate the Contemplated Transactions. The Q32 Board (at meetings duly called and held) has (i) determined that the Contemplated Transactions are fair to, advisable and in the best interests of Q32 and its stockholders, (ii) approved and declared advisable this Agreement and the Contemplated Transactions and (iii) determined to recommend the Q32 Board Recommendation to the stockholders of Q32. This Agreement has been duly executed and delivered by Q32 and assuming the due authorization, execution and delivery by Homology and Merger Sub, constitutes the legal, valid and binding obligation of Q32, enforceable against Q32 in accordance with its terms, subject to the Enforceability Exceptions.

3.4 Vote Required. The affirmative vote of the holders of at least (i) a majority of the then outstanding shares of Q32 Common Stock outstanding on the record date for the Q32 Stockholder Written Consent and (ii) a majority of the then outstanding shares of Q32 Preferred Stock voting as a single class on an as-converted basis (together, the “Required Q32 Stockholder Vote”), is the only vote of the holders of any class or series of Q32 Capital Stock necessary to adopt and approve this Agreement and approve the Contemplated Transactions. No interest in Q32 is subject to any appraisal or dissenters rights in connection with the Contemplated Transactions.

3.5 Non-Contravention; Consents.

(a) Subject to obtaining the Required Q32 Stockholder Vote and the filing of the Certificate of Merger required by Delaware Law, neither (x) the execution, delivery or performance of this Agreement by Q32, nor (y) the consummation of the Contemplated Transactions, will directly or indirectly (with or without notice or lapse of time):

(i) contravene, conflict with or result in a violation of any of the provisions of the Organizational Documents of Q32 or its Subsidiaries;

(ii) contravene, conflict with or result in a material violation of, or give any Governmental Authority or other Person the right to challenge the Contemplated Transactions or to exercise any remedy or obtain any relief under, any Law or any Order to which Q32 or its Subsidiaries, or any of the assets owned or used by Q32 or its Subsidiaries, is subject;

(iii) contravene, conflict with or result in a material violation of any of the terms or requirements of, or give any Governmental Authority the right to revoke, withdraw, suspend, cancel, terminate or modify, any Governmental Authorization that is held by Q32 or its Subsidiaries or that otherwise relates to the business of Q32, or any of the assets owned, leased or used by Q32;

(iv) contravene, conflict with or result in a violation or breach of, or result in a default under, any provision of any Q32 Material Contract, or give any Person the right to: (A) declare a default or exercise any remedy under any Q32 Material Contract, (B) any material payment, rebate, chargeback, penalty or change in delivery schedule under any such Q32 Material Contract, (C) accelerate the maturity or performance of any Q32 Material Contract or (D) cancel, terminate or modify any term of any Q32 Material Contract, except in the case of any nonmaterial breach, default, penalty or modification; or

(v) result in the imposition or creation of any Encumbrance upon or with respect to any asset owned or used by Q32 or its Subsidiaries (except for Permitted Encumbrances).

 

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(b) Except for (i) any Consent set forth on Section 3.5 of the Q32 Disclosure Schedule under any Q32 Contract, (ii) the Required Q32 Stockholder Vote, (iii) the filing of the Certificate of Merger with the Secretary of State of the State of Delaware pursuant to Delaware Law and (iv) such consents, waivers, approvals, orders, authorizations, registrations, declarations and filings as may be required under applicable federal and state securities laws, neither Q32 nor any of its Subsidiaries was, is or will be required to make any filing with or give any notice to, or to obtain any Consent from, any Person in connection with (x) the execution, delivery or performance of this Agreement or (y) the consummation of the Contemplated Transactions.

(c) The Q32 Board has taken and will take all actions necessary to ensure that the restrictions applicable to business combinations contained in Section 203 of Delaware Law are, and will be, inapplicable to the execution, delivery and performance of this Agreement and to the consummation of the Contemplated Transactions. No other state takeover statute or similar Law applies or purports to apply to the Merger, this Agreement or any of the other Contemplated Transactions.

3.6 Capitalization.

(a) The authorized capital stock of Q32 consists of (i) 141,900,000 shares of Q32 Common Stock of which 7,274,482 shares have been issued and are outstanding as of November 12, 2023 , and (ii) 117,933,356 shares of Q32 Preferred Stock of which (a) 6,500,000 shares have been designated Q32 Series A1 Preferred Stock of which 6,500,000 shares have been issued and are outstanding as of November 12, 2023, (b) 47,628,788 shares have been designated Q32 Series A Preferred Stock of which 47,628,788 shares have been issued and are outstanding as of November 12, 2023 and (d) 63,804,568 shares have been designated Q32 Series B Preferred Stock of which 54,689,627 shares have been issued and are outstanding as of November 12, 2023. Q32 does not hold any shares of its capital stock in its treasury.

(b) All of the outstanding shares of Q32 Common Stock have been duly authorized and validly issued, and are fully paid and nonassessable and are free of any Encumbrances other than under applicable securities Laws. None of the outstanding shares of Q32 Common Stock is entitled or subject to any preemptive right, right of participation, right of maintenance or any similar right. None of the outstanding shares of Q32 Common Stock is subject to any right of first refusal in favor of Q32. Except as contemplated herein, there is no Q32 Contract relating to the voting or registration of, or restricting any Person from purchasing, selling, pledging or otherwise disposing of (or granting any option or similar right with respect to), any shares of Q32 Common Stock. Q32 is not under any obligation, nor is Q32 bound by any Contract pursuant to which it may become obligated, to repurchase, redeem or otherwise acquire any outstanding shares of Q32 Common Stock or other securities. Section (b) of the Q32 Disclosure Schedule accurately and completely describes all repurchase rights held by Q32 with respect to shares of Q32 Common Stock (including shares issued pursuant to the exercise of stock options) and specifies which of those repurchase rights are currently exercisable.

(c) Except for the Q32 Equity Plan and the Q32 Options granted thereunder, Q32 does not have any stock incentive plan or any other plan, program, agreement or arrangement providing for any equity or equity-based compensation for any Person and there were no other equity or equity-based awards outstanding as of the date of this Agreement. As of the date of this Agreement, Q32 has reserved 25,956,535 shares of Q32 Common Stock for issuance under the Q32 Equity Plan, of which 24,450,104 shares have been issued and are outstanding pursuant to the exercise of Q32 Options, 24,336,980 shares are subject to outstanding Q32 Options, and 97,505 shares remain available for future grant pursuant to the Q32 Equity Plan. Section 3.6(c) of the Q32 Disclosure Schedule sets forth a true and complete list, as of the date of this Agreement, of each outstanding Q32 Option, including: (i) the name of the holder, (ii) the number of shares of Q32 Common Stock subject to such Q32 Option, (iii) the exercise price of each Q32 Option, (iv) the date on which such Q32 Option, (v) the applicable vesting schedule, including any acceleration provisions, and the number of vested and unvested shares, (vi) the expiration date, as applicable, and (vii) whether the Q32 Option is intended to be an “incentive stock option” (as defined in the Code) or a non-qualified stock option. Q32 has made available to Homology accurate and complete copies of the following: (A) the standard form of agreement evidencing Q32 Options; and (B) each

 

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agreement evidencing a Q32 Option that does not conform in all material respects to the standard form agreement.

(d) Except as set forth on Section 3.6(c) of the Q32 Disclosure Schedule, there is no: (i) outstanding subscription, option, call, warrant or right (whether or not currently exercisable) to acquire any shares of the capital stock or other securities of Q32, (ii) outstanding security, instrument or obligation that is or may become convertible into or exchangeable for any shares of the capital stock or other securities of Q32, (iii) stockholder rights plan (or similar plan commonly referred to as a “poison pill”) or Contract under which Q32 is or may become obligated to sell or otherwise issue any shares of its capital stock or any other securities or (iv) condition or circumstance that may give rise to or provide a basis for the assertion of a claim by any Person to the effect that such Person is entitled to acquire or receive any shares of capital stock or other securities of Q32.

(e) All outstanding shares of Q32 Common Stock, and other securities of Q32 have been issued and granted in compliance with (i) all applicable securities laws and other applicable Law and (ii) all requirements set forth in applicable Contracts.

3.7 Financial Statements.

(a) Section 3.7(a) of the Q32 Disclosure Schedule includes true and complete copies of (i) the Q32 Balance Sheet and the related audited estimated statement of income, cash flow and changes in partners’ capital for the years ended December 31, 2021 and December 31, 2022 (the “Q32 Audited Financial Statements”), and (ii) Q32’s unaudited balance sheet and the related unaudited estimated statement of income, cash flow and changes in partners’ capital for the three and six (6) months ended June 30, 2023 (the “Q32 Interim Financial Statements” and collectively, with the Q32 Audited Financial Statements, the “Q32 Financial Statements”).

(b) The Q32 Financial Statements (i) were prepared in accordance with GAAP (except the Q32 Interim Financial Statements and are subject to normal and recurring year-end adjustments that are not reasonably expected to be material in amount) applied on a consistent basis unless otherwise noted therein throughout the periods indicated, (ii) fairly present, in all material respects, the financial position of Q32 as of the respective dates thereof and the results of operations and cash flows of Q32 for the periods covered thereby and (iii) when delivered by Q32 for inclusion in the Registration Statement (as defined below) for filing with the SEC following the date of this Agreement in accordance with Section 5.7, shall comply in all material respects with the applicable accounting requirements and with the rules and regulations of the SEC, the Exchange Act and the Securities Act applicable to a registrant, in effect as of the respective dates thereof. Other than as expressly disclosed in the Q32 Financial Statements, there has been no material change in Q32’s accounting methods or principles that would be required to be disclosed in Q32’s financial statements in accordance with GAAP. The books of account and other financial records of Q32 and each of its Subsidiaries are true and complete in all material respects.

(c) There have been no formal internal investigations regarding financial reporting or accounting policies and practices discussed with, reviewed by or initiated at the direction of the chief executive officer, chief financial officer, or general counsel of Q32, the Q32 Board or any committee thereof, other than ordinary course audits or reviews of accounting policies and practices or internal controls.

(d) Q32 and its Subsidiaries maintains a system of internal accounting controls designed to provide reasonable assurance that: (i) transactions are executed in accordance with management’s general or specific authorizations, (ii) transactions are recorded as necessary to permit preparation of the financial statements of Q32 and its Subsidiaries in conformity with GAAP and to maintain accountability of the Company’s and its Subsidiaries’ assets, (iii) access to Q32’s and its Subsidiaries’ assets is permitted only in accordance with management’s general or specific authorization and (iv) the recorded accountability for Q32 and its Subsidiaries’ assets is compared with the existing assets at regular intervals and appropriate action is taken with respect to any differences. Q32 and each of its Subsidiaries maintains internal control over financial reporting that provides

 

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reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP.

(e) Q32’s auditor has at all times since the date of enactment of the Sarbanes-Oxley Act been: (i) a registered public accounting firm (as defined in Section 2(a)(12) of the Sarbanes-Oxley Act), (ii) to the Knowledge of Q32, “independent” with respect to Q32 within the meaning of Regulation S-X under the Exchange Act and (iii) to the Knowledge of Q32, in compliance with subsections (g) through (l) of Section 10A of the Exchange Act and the rules and regulations promulgated by the SEC and the Public Company Accounting Oversight Board (“PCAOB”) thereunder (such firm, the “PCAOB Auditor”).

3.8 Absence of Changes. Except as set forth on Section 3.8 of the Q32 Disclosure Schedule, since January 1, 2022, Q32 and its Subsidiaries have conducted their business only in the Ordinary Course of Business (except for the execution and performance of this Agreement and the discussions, negotiations and transactions related thereto) and there has not been any (a) Q32 Material Adverse Effect or (b) action, event or occurrence that would have required consent of Homology pursuant to Section 5.1 of this Agreement had such action, event or occurrence taken place after the execution and delivery of this Agreement.

3.9 Absence of Undisclosed Liabilities. Neither Q32 nor any of its Subsidiaries has any liability, indebtedness, obligation, expense, claim, deficiency, guaranty or endorsement of any kind, whether accrued, absolute, contingent, matured, unmatured or otherwise (each a “Liability”), in each case, of a type required to be reflected or reserved for on a balance sheet prepared in accordance with GAAP, except for: (a) Liabilities disclosed, reflected or reserved against in the Q32 Balance Sheet, (b) normal and recurring current Liabilities that have been incurred by Q32 or its Subsidiaries since the date of the Q32 Balance Sheet in the Ordinary Course of Business (none of which relates to any breach of contract, breach of warranty, tort, infringement, or violation of Law), (c) Liabilities for performance of obligations of Q32 or any of its Subsidiaries under Q32 Contracts, (d) Liabilities incurred in connection with the Contemplated Transactions and (e) Liabilities described in Section 3.9 of the Q32 Disclosure Schedule.

3.10 Title to Assets. Each of Q32 and its Subsidiaries has good and valid title to, or, in the case of leased properties and assets, valid leasehold interests in, all tangible properties or tangible assets and equipment used or held for use in its business or operations or purported to be owned by it, including: (a) all tangible assets reflected on the Q32 Balance Sheet and (b) all other tangible assets reflected in the books and records of Q32 as being owned by Q32. All of such assets are owned or, in the case of leased assets, leased by Q32 or any of its Subsidiaries free and clear of any Encumbrances, other than Permitted Encumbrances.

3.11 Real Property; Leasehold. Neither Q32 nor any of its Subsidiaries owns or has ever owned any real property. Q32 has made available to Homology (a) an accurate and complete list of all real properties with respect to which Q32 directly or indirectly holds a valid leasehold interest as well as any other real estate that is in the possession of or leased by Q32 or any of its Subsidiaries and (b) copies of all leases under which any such real property is possessed (the “Q32 Real Estate Leases”), each of which is in full force and effect, with no existing material default thereunder.

3.12 Intellectual Property.

(a) Section 3.12(a) of the Q32 Disclosure Schedule is an accurate, true and complete listing of all Q32 Registered IP, including for each item (i) the record owner (and name of any other Person with an ownership interest in such item of Q32 Registered IP, if any), jurisdiction (or, with respect to domain names, the applicable registrar), status, date and registration or application number of each item, as applicable, (ii) the name of the record owner and any other Person that has an ownership interest in such item of Q32 Registered IP, and the nature of such ownership interest, and (iii) any actions that are required to be taken within 180 days of the date hereof for any Q32 Registered IP, including the payment of any registration, maintenance or renewal fees or the filing of or response to any documents, applications or certificates, for the purposes of prosecuting, obtaining,

 

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perfecting, maintaining or renewing any Q32 Registered IP. Section 3.12(a) of the Q32 Disclosure Schedule also sets forth, as of the date of this Agreement, a list of all internet domain names with respect to which Q32 or any of its Subsidiaries are the registrant and, with respect to each domain name, the record owner of such domain name and if different, the legal and beneficial owner(s) of such domain name and the applicable domain name registrar.

(b) Section 3.12(b) of the Q32 Disclosure Schedule accurately identifies all Q32 Contracts pursuant to which any material Q32 IP Rights are licensed to Q32 (other than (A) any non-customized software that (1) is so licensed solely in executable or object code form pursuant to a nonexclusive, internal use software license and other Intellectual Property associated with such software and (2) is not incorporated into, or material to the development, manufacturing, or distribution of, any of Q32’s or its Subsidiaries’ products or services, (B) any Intellectual Property licensed on a nonexclusive basis ancillary to the purchase or use of equipment, reagents or other materials, (C) any confidential information provided under confidentiality agreements and (D) agreements between Q32 or its Subsidiaries and their respective employees in Q32’s standard form thereof). To the Knowledge of Q32, each Q32 Contract listed in Section 3.12(b) of the Q32 Disclosure Schedule is in full force and effect and constitutes a legal, valid, and binding obligation of Q32, its Subsidiaries and each other party thereto, and is enforceable against Q32, its Subsidiaries and each other party thereto in accordance with its terms. To the Knowledge of Q32, neither Q32, its Subsidiaries, nor any other party to any Q32 Contract listed in Section 3.12(b) of the Q32 Disclosure Schedule has been or is, or has been or is alleged to be, in material default under, or has provided or received any notice of breach under, or intention to terminate (including by non-renewal), any Q32 Contract listed in Section 3.12(b) of the Q32 Disclosure Schedule, except as would not reasonably be expected to have, individually or in the aggregate, a Q32 Material Adverse Effect.

(c) Except for instances that would not reasonably be expected to have, individually or in the aggregate, a Q32 Material Adverse Effect, Section 3.12(c) of the Q32 Disclosure Schedule accurately identifies each Q32 Contract pursuant to which any Person has been granted any license under, or otherwise has received or acquired any right (whether or not currently exercisable) or interest in, any Q32 IP Rights (other than (i) any confidential information provided under confidentiality agreements and (ii) any Q32 IP Rights nonexclusively licensed to academic collaborators, suppliers or service providers for the sole purpose of enabling such academic collaborator, supplier or service providers to provide services for Q32’s or its Subsidiaries’ benefit). To the Knowledge of Q32, each Q32 Contract listed in Section 3.12(c) of the Q32 Disclosure Schedule is in full force and effect and constitutes a legal, valid, and binding obligation of Q32, its Subsidiaries and each other party thereto, and is enforceable against Q32, its Subsidiaries and each other party thereto in accordance with its terms. Neither Q32, its Subsidiaries nor, to the Knowledge of Q32, any other party to any Q32 Contract listed in Section 3.12(c) of the Q32 Disclosure Schedule has provided or received any written notice or allegation of breach under, or intention to terminate (including by non-renewal), any Q32 Contract listed in Section 3.12(c) of the Q32 Disclosure Schedule.

(d) Except as identified on Section 3.12(d) of the Q32 Disclosure Schedule, neither Q32 nor any of its Subsidiaries is bound by, no Q32 Owned IP Rights are subject to, and to the Knowledge of Q32, no Q32 Licensed IP Rights are subject to (other than the rights of the applicable licensors), any Contract containing any covenant or other provision that in any way limits or restricts the ability of Q32 or any of its Subsidiaries to use, exploit, assert, or enforce any Q32 IP Rights anywhere in the world, except as would not reasonably be expected to have, individually or in the aggregate, a Q32 Material Adverse Effect.

(e) Q32 or one of its Subsidiaries exclusively owns all right, title, and interest to and in the Q32 IP Rights (other than (i) Q32 Licensed IP Rights, or co-owned rights each as identified in Section 3.12(b) of the Q32 Disclosure Schedule, (ii) any non-customized software that (A) is licensed to Q32 or its Subsidiaries solely in executable or object code form pursuant to a nonexclusive, internal use software license and other Intellectual Property associated with such software and (B) is not incorporated into, or material to the development, manufacturing, or distribution of, any of Q32’s or its Subsidiaries’ products or services and (iii) any Intellectual Property licensed on a nonexclusive basis ancillary to the purchase or use of equipment, reagents or other materials), in each case, free and clear of any Encumbrances (other than Permitted Encumbrances).

 

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(f) To the Knowledge of Q32, (i) all documents and instruments necessary to register or apply for or renew registration of Q32 Registered IP owned by Q32, and (ii) all documents and instruments necessary to register or apply for or renew registration of Q32 Registered IP exclusively licensed to Q32, have been validly executed, delivered, and filed in a timely manner with the appropriate Governmental Authority. To the Knowledge of Q32, (i) Q32 has filed all statements of use and paid all renewal and maintenance fees, annuities and other fees with respect to the Q32 Registered IP owned by Q32 and (ii) Q32 has executed all documents and instruments necessary to register or apply for or renew registration of Q32 Registered IP exclusively licensed to Q32, in each case (i) and (ii), that are due and payable as of the date of this Agreement.

(g) Except for instances that would not reasonably be expected to have, individually or in the aggregate, a Q32 Material Adverse Effect, to the Knowledge of Q32 each Person who is or was an employee, contractor or consultant of Q32 or any of its Subsidiaries and who is or was involved in the creation, discovery, reduction to practice or development of any Intellectual Property for Q32 or any of its Subsidiaries has signed a valid, enforceable written agreement containing a present assignment of all right, title and interest in and to such Intellectual Property to Q32 or such Subsidiary and confidentiality provisions protecting trade secrets and confidential information of Q32 and its Subsidiaries.

(h) To the Knowledge of Q32, no current or former member, officer, director, or employee of Q32 or any of its Subsidiaries has any claim, right (whether or not currently exercisable), or interest to or in any Q32 IP Rights purported to be owned by Q32. To the Knowledge of Q32, no employee of Q32 or any of its Subsidiaries is (A) bound by or otherwise subject to any Contract restricting him or her from performing his or her duties for Q32 or such Subsidiary or (B) in breach of any Contract with any former employer or other Person concerning Q32 IP Rights purported to be owned by Q32 or such Subsidiary or confidentiality provisions protecting trade secrets and confidential information comprising Q32 IP Rights purported to be owned by Q32 or such Subsidiary.

(i) Except as set forth on Section 3.12(i) of the Q32 Disclosure Schedule, no funding, facilities, or personnel of any Governmental Authority were used, directly or indirectly, to develop or create, in whole or in part, any Q32 Owned IP Rights, or, to the Knowledge of Q32, any Q32 Licensed IP Rights, and no educational institution has any right to, or right to royalties for, or to impose any requirement on the manufacture or commercialization of any product incorporating, any Q32 Owned IP Rights, or, to the Knowledge of Q32, any Q32 Licensed IP Rights. To the Knowledge of Q32, no Governmental Authority has any right to (including any “step-in” or “march-in” rights with respect to), ownership of, commercialization of, or right to royalties or other payments for any Q32 Owned IP Rights, or, to the Knowledge of Q32, any Q32 Licensed IP Rights. Without limiting the generality of the foregoing, to the Knowledge of Q32, no invention claimed or covered by any Patent within the Q32 Owned IP Rights, or, to the Knowledge of Q32, any Q32 Licensed IP Rights, (A) was conceived or reduced to practice in connection with any research activities funded, in whole or in part, by the federal government of the United States or any agency thereof, (B) is a “subject invention” as that term is described in 35 U.S.C. Section 201(e), or (C) is otherwise subject to the provisions of the Bayh-Dole Act or any similar Law of any other jurisdiction, including with respect to any Patents that are part of the Q32 IP Rights.

(j) Q32 and each of its Subsidiaries has taken reasonable steps to maintain the confidentiality of and otherwise protect, maintain and enforce its rights in all proprietary information that Q32 or such Subsidiary holds, or purports to hold, as confidential or a trade secret. To the Knowledge of Q32, neither Q32 nor any of its Subsidiaries has made any of its trade secrets or other material confidential or proprietary information that it intended to maintain as confidential information available to any other Person except pursuant to written agreements requiring such Person to maintain the confidentiality of such trade secrets or confidential information. To the Knowledge of Q32, there have been no material security breaches, outages, violations or unauthorized access to any of the proprietary information that Q32 or any of its Subsidiaries holds, or purports to hold, as confidential or a trade secret, except as would not reasonably be expected to have, individually or in the aggregate, a Q32 Material Adverse Effect.

 

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(k) Except as set forth on Section 3.12(k) of the Q32 Disclosure Schedule, neither Q32 nor any of its Subsidiaries has assigned or otherwise transferred ownership of, or agreed to assign or otherwise transfer ownership of, any Q32 IP Rights to any other Person.

(l) To the Knowledge of Q32, neither Q32 nor any of its Subsidiaries has taken or failed to take any action that could be reasonably expected to result in the abandonment, invalidity, cancellation, forfeiture, relinquishing, invalidation or unenforceability of any Q32 IP Rights (including with respect to any trademark, a failure to exercise adequate quality controls or an assignment in gross without the accompanying goodwill). To the Knowledge of Q32, each item of Q32 IP Right has been duly maintained and is not expired, abandoned or cancelled. To the Knowledge of Q32, each of the Patents included in the Q32 IP Rights identifies each and every inventor of the claims thereof as determined in accordance with the applicable laws of the jurisdiction in which such Patent is issued or pending. To the Knowledge of Q32, neither Q32 nor any of its Subsidiaries has engaged in patent or copyright misuse or any fraud or inequitable conduct in connection with any Q32 IP Right. To the Knowledge of Q32, each of Q32 and its Subsidiaries and their respective patent counsel have complied with its duty of candor and disclosure and have made no material misrepresentations in the filings submitted to the applicable Governmental Authorities with respect to all Patents included in the Q32 IP Rights for which Q32 or any of its Subsidiaries is responsible for prosecuting.

(m) To the Knowledge of Q32, the Q32 IP Rights constitute all Intellectual Property necessary for Q32 to conduct its business as currently conducted or proposed to be conducted; provided, however, that the foregoing representation is not a representation with respect to non-infringement of Intellectual Property.

(n) Q32 has delivered, or made available to Homology, a complete and accurate copy of all material Q32 IP Rights Agreements.

(o) To the Knowledge of Q32, the manufacture, marketing, offering for sale, sale, importation, use or intended use or other disposal of any product as currently sold or under development by Q32 does not violate any license or agreement between Q32 or its Subsidiaries and any third party in any material respect, and, to the Knowledge of Q32, does not infringe or misappropriate any valid and issued Patent or other Intellectual Property of any other Person, which infringement or misappropriation would reasonably be expected to have a Q32 Material Adverse Effect. To the Knowledge of Q32, no third party is infringing upon any Patents owned by Q32 within the Q32 IP Rights, or otherwise violating any Q32 IP Rights Agreement.

(p) Except as set forth on Section 3.12(p) of the Q32 Disclosure Schedule, as of the date of this Agreement, neither Q32 nor any of its Subsidiaries is a party to any Legal Proceeding (including, but not limited to, opposition, interference or other proceeding in any patent or other government office) contesting the validity, ownership or right to use, sell, offer for sale, license or dispose of any Q32 IP Rights. None of the Q32 Owned IP Rights, and to the Knowledge of Q32, none of the Q32 Licensed IP rights, have been adjudged invalid or unenforceable in whole or part, and all Q32 Owned IP Rights, and to the Knowledge of Q32, all Q32 Licensed IP rights, are in full force and effect. No Patents within the Q32 Registered IP owned by Q32, or to the Knowledge of Q32, no Patents within the Q32 Registered IP exclusively licensed to Q32, have been subject to any interference, derivation, reexamination (including ex parte reexamination, inter partes reexamination, inter partes review, or post grant review), reissue, cancellation, opposition, claim, allegation or other action, including any proceeding in which the scope, validity, inventorship, ownership or enforceability of any such Patent is being, has been, or could reasonably be expected to be, contested or challenged. Neither Q32 nor any of its Subsidiaries have received any written notice asserting that any Q32 IP Rights or the proposed use, sale, offer for sale, license or disposition of products, methods, or processes claimed or covered thereunder infringes or misappropriates or violates the rights of any other Person or that Q32 or any of its Subsidiaries have otherwise infringed, misappropriated or otherwise violated any Intellectual Property of any Person.

(q) Except as set forth on Section 3.12(q) of the Q32 Disclosure Schedule, to the Knowledge of Q32, no trademark (whether registered or unregistered) or trade name owned, used, or applied for by Q32 conflicts or

 

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interferes with any trademark (whether registered or unregistered) or trade name owned, used, or applied for by any other Person except as would not have a Q32 Material Adverse Effect. To the Knowledge of Q32, none of the goodwill associated with or inherent in any trademark (whether registered or unregistered) in which Q32 or its Subsidiaries has or purports to have an ownership interest has been impaired as determined by Q32 in accordance with GAAP. Section 3.12(q) of the Q32 Disclosure Schedule sets forth all material unregistered trademarks included in the Q32 IP Rights.

(r) Except (i) as would reasonably not be expected to have a Q32 Material Adverse Effect, (ii) as may be set forth in Sections 3.12(a) or 3.12(b) of the Q32 Disclosure Schedule or (iii) as contained in license, distribution or service agreements entered into in the Ordinary Course of Business by Q32, to the Knowledge of Q32, (A) neither Q32 nor any of its Subsidiaries is bound by any Contract to indemnify, defend, hold harmless, or reimburse any other Person with respect to any Intellectual Property infringement, misappropriation, or similar claim which is material to Q32 or any of its Subsidiaries, taken as a whole and (B) neither Q32 nor any of its Subsidiaries has ever assumed, or agreed to discharge or otherwise take responsibility for, any existing or potential liability of another Person for infringement, misappropriation, or violation of any Intellectual Property right, which assumption, agreement or responsibility remains in force as of the date of this Agreement.

(s) To the Knowledge of Q32, neither Q32 nor any of its Subsidiaries is party to any Contract that, as a result of such execution, delivery and performance of this Agreement, will (i) cause the grant, assignment, or transfer to any other third party of any license or other right to or in any Q32 IP Rights, (ii) result in breach of, default under, termination of, or acceleration or modification of such Contract with respect to any Q32 IP Rights, (iii) alter, encumber, impair or extinguish, or result in any Encumbrance with respect to the right of Q32 or the Surviving Corporation and its Subsidiaries to use, sell or license or enforce any Q32 IP Rights or portion thereof, or (iv) result in Q32 or any of its Subsidiaries being bound by or subject to any exclusivity obligations, non-compete or other restrictions on the operation or scope of their respective businesses, or to any obligation to grant any rights in or to any Q32 IP Rights, except, in each of (i), (ii), (iii) and (iv), for the occurrence of any such grant or impairment that would not individually or in the aggregate, reasonably be expected to result in a Q32 Material Adverse Effect.

3.13 Agreements, Contracts and Commitments.

(a) Section 3.13(a) of the Q32 Disclosure Schedule lists the following Q32 Contracts in effect as of the date of this Agreement (each, a “Q32 Material Contract” and collectively, the “Q32 Material Contracts”):

(i) each Q32 Contract that is a collective bargaining agreement or other agreement or arrangement with any labor union, works council or labor organization;

(ii) each Q32 Contract for the employment or engagement of any individual on an employee, consulting or other basis that provides for annual base compensation in excess of $200,000;

(iii) each Q32 Contract with any Q32 Associate that provides for retention, change in control, transaction or other similar payments or benefits, whether or not payable as a result of the Contemplated Transactions;

(iv) each Q32 Contract relating to any agreement of indemnification or guaranty not entered into in the Ordinary Course of Business;

(v) each Q32 Contract containing (A) any covenant limiting the freedom of Q32 or any of its Subsidiaries or the Surviving Corporation to engage in any line of business or compete with any Person, or limiting the development, manufacture, or distribution of Q32’s products or services, (B) any most-favored pricing arrangement, (C) any exclusivity provision or (D) any non-solicitation provision;

(vi) each Q32 Contract (A) pursuant to which any Person granted Q32 an exclusive license under any Intellectual Property, or (B) pursuant to which Q32 granted any Person an exclusive license under any Q32 IP Rights;

 

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(vii) each Q32 Contract relating to capital expenditures and requiring payments after the date of this Agreement in excess of $500,000 pursuant to its express terms and not cancelable without penalty;

(viii) each Q32 Contract relating to the disposition or acquisition of material assets or any ownership interest in any Entity, in each case, involving payments in excess of $250,000 after the date of this Agreement;

(ix) each Q32 Contract relating to any mortgages, indentures, loans, notes or credit agreements, security agreements or other agreements or instruments relating to the borrowing of money or extension of credit in excess of $500,000 or creating any material Encumbrances with respect to any assets of Q32 or any loans or debt obligations with officers or directors of Q32;

(x) each Q32 Contract requiring payment by or to Q32 after the date of this Agreement in excess of $500,000 pursuant to its express terms relating to: (A) any distribution agreement (identifying any that contain exclusivity provisions), (B) any agreement involving provision of services or products with respect to any pre-clinical or clinical development activities of Q32, (C) any dealer, distributor, joint marketing, alliance, joint venture, cooperation, development or other agreement currently in force under which Q32 or any of its Subsidiaries has continuing obligations to develop or market any product, technology or service, or any agreement pursuant to which Q32 or any of its Subsidiaries has continuing obligations to develop any Intellectual Property that will not be owned, in whole or in part, by Q32 or such Subsidiary or (D) any Contract to license any Patent, trademark registration, service mark registration, trade name or copyright registration to or from any third party to manufacture or produce any product, service or technology of Q32 or any of its Subsidiaries or any Contract to sell, distribute or commercialize any products or service of Q32 or any of its Subsidiaries, in each case, except for Q32 Contracts entered into in the Ordinary Course of Business;

(xi) each Q32 Contract with any Person, including any financial advisor, broker, finder, investment banker or other Person, providing advisory services to Q32 in connection with the Contemplated Transactions;

(xii) each Q32 Contract to which Q32 or any of its Subsidiaries is a party or by which any of their assets and properties is currently bound, which involves annual obligations of payment by, or annual payments to, Q32 or such Subsidiary in excess of $500,000;

(xiii) a Q32 Real Estate Lease;

(xiv) a Contract disclosed in or required to be disclosed in Section 3.12(a) or Section 3.12(b) of the Q32 Disclosure Schedule; or

(xv) any other Q32 Contract that is not terminable at will (with no penalty or payment) by Q32 or any of its Subsidiaries, and (A) which involves payment or receipt by Q32 or such Subsidiary after the date of this Agreement under any such agreement, contract or commitment of more than $500,000 in the aggregate, or obligations after the date of this Agreement in excess of $1,000,000 in the aggregate or (B) that is material to the business or operations of Q32 and its Subsidiaries taken as a whole.

(b) Q32 has delivered or made available to Homology accurate and complete copies of all Q32 Material Contracts, including all amendments thereto. There are no Q32 Material Contracts that are not in written form. Q32 has not, nor to Q32’s Knowledge, as of the date of this Agreement, has any other party to a Q32 Material Contract, breached, violated or defaulted under, or received notice that it breached, violated or defaulted under, any of the terms or conditions of any Q32 Material Contract in such manner as would permit any other party to cancel or terminate any such Q32 Material Contract, or would permit any other party to seek damages which would reasonably be expected to have a Q32 Material Adverse Effect. As to Q32 and its Subsidiaries, as of the date of this Agreement, each Q32 Material Contract is valid, binding, enforceable and in full force and effect, subject to the Enforceability Exceptions. No Person is renegotiating, or has a right pursuant to the terms of any Q32 Material Contract to change, any material amount paid or payable to Q32 under any Q32 Material Contract or any other material term or provision of any Q32 Material Contract.

 

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3.14 Compliance; Permits; Restrictions.

(a) Q32 and each of its Subsidiaries is, and since January 1, 2020 has been, in material compliance with all applicable Laws. No investigation, claim, suit, proceeding, audit, Order, or other action by any Governmental Authority is pending or, to the Knowledge of Q32, threatened against Q32 or any of its Subsidiaries. There is no agreement or Order binding upon Q32 or any of its Subsidiaries which (i) has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Q32 or any of its Subsidiaries, any acquisition of material property by Q32 or any of its Subsidiaries or the conduct of business by Q32 or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Q32’s ability to comply with or perform any covenant or obligation under this Agreement or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.

(b) Each of Q32 and its Subsidiaries holds all required Governmental Authorizations that are material to the operation of the business of Q32 as currently conducted (collectively, the “Q32 Permits”). Section 3.14(b) of the Q32 Disclosure Schedule identifies each Q32 Permit. Each of Q32 and its Subsidiaries is in material compliance with the terms of Q32 Permits. No Legal Proceeding is pending or, to the Knowledge of Q32, threatened, which seeks to revoke, substantially limit, suspend, or materially modify any Q32 Permit.

(c) There are no Legal Proceedings pending or, to the Knowledge of Q32, threatened in writing with respect to an alleged material violation by Q32 or any of its Subsidiaries of the Federal Food, Drug, and Cosmetic Act (“FDCA”), the Public Health Service Act (“PHSA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substances Act or any other Law promulgated by the FDA or other Governmental Authority responsible for regulation of the research, development, testing, manufacturing, packaging, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of drug or biologic products (“Drug Regulatory Agency”).

(d) Each of Q32 and its Subsidiaries holds all required material Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Q32 as currently conducted, and, as applicable, the research, development, testing, manufacturing, packaging, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its product candidates (the “Q32 Product Candidates”) (collectively, the “Q32 Regulatory Permits”) and no such Q32 Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any material, adverse manner. Q32 has timely maintained and is in compliance in all material respects with the Q32 Regulatory Permits and neither Q32 nor any of its Subsidiaries has, since January 1, 2020, received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Q32 Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Q32 Regulatory Permit.

(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Q32 and its Subsidiaries, in which Q32 Product Candidates, have participated, were and, if still pending, are being conducted in compliance in all material respects with the applicable regulations of the Drug Regulatory Agencies and other applicable Law, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Neither Q32 nor any of its Subsidiaries has received any written notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to the Knowledge of Q32, any action to place a clinical hold order on, or otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, Q32 or any of its Subsidiaries or in which Q32 Product Candidates, have participated.

(f) Neither Q32 nor any of its Subsidiaries, and, to the Knowledge of Q32, any contract manufacturer with respect to any Q32 Product Candidate, is the subject of any pending or, to the Knowledge of Q32, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991)

 

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and any amendments thereto, or any other applicable Law. To the Knowledge of Q32, neither Q32 nor any of its Subsidiaries nor any contract manufacturer with respect to any Q32 Product Candidate has committed any acts, made any statement, or failed to make any statement, in each case in respect of Q32’s business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto, or any other applicable Law. None of Q32, any of its Subsidiaries, and to the Knowledge of Q32, any contract manufacturer with respect to any Q32 Product Candidate, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion under (i) 21 U.S.C. Section 335a, (ii) 42 U.S.C. § 1320a-7, or (iii) any other applicable Law. To the Knowledge of Q32, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Q32, any of its Subsidiaries, and to the Knowledge of Q32, any contract manufacturer with respect to any Q32 Product Candidate, or any of its respective officers, employees or agents. Neither Q32 nor any of its Subsidiaries is a party to or has any reporting obligations under any corporate integrity agreements, monitoring agreements, deferred or non-prosecution agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Authority.

(g) All manufacturing operations conducted by, or to the Knowledge of Q32, for the benefit of, Q32 or its Subsidiaries in connection with any Q32 Product Candidate, since January 1, 2020, have been and are being conducted in compliance in all material respects with applicable Laws, including the FDA’s standards for current good manufacturing practices, including applicable requirements contained in 21 C.F.R. Parts 210, 211 and 600-680 and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States.

(h) No laboratory or manufacturing site owned by Q32 or its Subsidiaries, and to the Knowledge of Q32, no manufacturing site of a contract manufacturer or laboratory, with respect to any Q32 Product Candidate, (i) is subject to a Drug Regulatory Agency shutdown or import or export prohibition or (ii) has since January 1, 2020 received any unresolved Form FDA 483, notice of violation, warning letter, untitled letter, or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting material noncompliance with any applicable Law, and, to the Knowledge of Q32, neither the FDA nor any other Governmental Authority is considering such action.

3.15 Legal Proceedings; Orders.

(a) There is no pending Legal Proceeding and, to the Knowledge of Q32, no Person has threatened in writing to commence any Legal Proceeding: (i) that involves Q32 or any of its Subsidiaries or any Q32 Associate (in his or her capacity as such) or any of the material assets owned or used by Q32 or any of its Subsidiaries or (ii) that challenges, or that may have the effect of preventing, delaying, making illegal or otherwise interfering with, the Contemplated Transactions.

(b) There is no Order to which Q32 or any of its Subsidiaries, or any of the material assets owned or used by Q32 or any of its Subsidiaries, is subject. To the Knowledge of Q32, no officer or other Key Employee of Q32 or any of its Subsidiaries is subject to any Order that prohibits such officer or employee from engaging in or continuing any conduct, activity or practice relating to the business of Q32 or any of its Subsidiaries or to any material assets owned or used by Q32 or any of its Subsidiaries.

3.16 Tax Matters.

(a) Each of Q32 and each of its Subsidiaries has timely filed all income Tax Returns and all other material Tax Returns that were required to be filed by or with respect to it under applicable Law. All such Tax Returns were correct and complete in all material respects and have been prepared in material compliance with all applicable Law. Subject to exceptions as would not be material, no claim has ever been made by a Governmental Authority in a jurisdiction where Q32 or any of its Subsidiaries does not file a particular type of Tax Return that

 

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Q32 or any of its Subsidiaries is subject to taxation by that jurisdiction that would require the filing of such a Tax Return.

(b) All material amounts of Taxes due and owing by Q32 and each of its Subsidiaries (whether or not shown on any Tax Return) have been timely paid. The unpaid Taxes of Q32 and each of its Subsidiaries for periods (or portions thereof) ending on or prior to the date of the Q32 Balance Sheet do not materially exceed the accruals for current Taxes set forth on the Q32 Balance Sheet. Since the date of the Q32 Balance Sheet, neither Q32 nor any of its Subsidiaries has incurred any material Liability for Taxes outside the Ordinary Course of Business or otherwise inconsistent with past custom and practice.

(c) Each of Q32 and each of its Subsidiaries has withheld and paid to the appropriate Governmental Authority all material Taxes required to have been withheld and paid in connection with any amounts paid or owing to any employee, independent contractor, creditor, stockholder, or other third party.

(d) There are no Encumbrances for material Taxes (other Encumbrances described in clause (i) of the definition of “Permitted Encumbrances”) upon any of the assets of Q32 or any of its Subsidiaries.

(e) No deficiencies for a material amount of Taxes with respect to Q32 or any of its Subsidiaries have been claimed, proposed or assessed by any Governmental Authority in writing that have not been timely paid in full. There are no pending (or, based on written notice, threatened) material audits, assessments, examinations or other actions for or relating to any Liability in respect of Taxes of Q32 or any of its Subsidiaries. Neither Q32 nor any of its Subsidiaries has waived any statute of limitations in respect of material Taxes or agreed to any extension of time with respect to a material Tax assessment or deficiency.

(f) Neither Q32 nor any of its Subsidiaries is a party to any Tax allocation, Tax sharing or similar agreement (including indemnity arrangements), other than customary indemnification provisions in commercial Contracts entered into in the Ordinary Course of Business with vendors, customers, lenders, or landlords (an “Ordinary Course Agreement”).

(g) Neither Q32 nor any of its Subsidiaries has been a member of an affiliated group filing a consolidated U.S. federal income Tax Return (other than a group the common parent of which is Q32). Neither Q32 nor any of its Subsidiaries has any material Liability for the Taxes of any Person (other than Q32) under Treasury Regulations Section 1.1502-6 (or any similar provision of state, local, or foreign law), as a transferee or successor, or by Contract (other than an Ordinary Course Agreement).

(h) Neither Q32 nor any of its Subsidiaries has distributed stock of another Person, or has had its stock distributed by another Person, in a transaction that was purported or intended to be governed in whole or in part by Section 355 of the Code or Section 361 of the Code.

(i) Neither Q32 nor any of its Subsidiaries has entered into any transaction identified as a “reportable transaction” for purposes of Treasury Regulations Section 1.6011-4(b)(2).

(j) Neither Q32 nor any of its Subsidiaries will be required to include any material item of income or gain in, or exclude any material item of deduction or loss from, taxable income for any taxable period (or portion thereof) ending after the Closing Date as a result of any: (i) change in, or use of improper, method of accounting for a taxable period ending on or prior to the Closing Date; (ii) “closing agreement” as described in Section 7121 of the Code (or any corresponding or similar provision of state, local or foreign income Tax law) executed on or prior to the Closing Date; (iii) installment sale or open transaction disposition made on or prior to the Closing Date; (iv) prepaid amount, advance payments or deferred revenue received or accrued on or prior to the Closing Date; or (v) intercompany transaction or excess loss amount described in Treasury Regulations under Section 1502 of the Code (or any corresponding or similar provision of state, local or foreign income Tax Law).

 

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(k) Section 3.16(k) of the Q32 Disclosure Schedule sets forth the entity classification of Q32 and each of its Subsidiaries for U.S. federal income tax purposes. Neither Q32 nor any of its Subsidiaries has made an election or taken any other action to change its federal and state income tax classification from such classification.

(l) Neither Q32 nor any of its Subsidiaries has taken or knowingly failed to take any action, nor to the Knowledge of Q32, are there any facts or circumstances, in each case, that would reasonably be expected to prevent or impede the Merger from qualifying for the Intended Tax Treatment.

3.17 Employee and Labor Matters; Benefit Plans.

(a) Section 3.17(a) of the Q32 Disclosure Schedule contains a complete and accurate list of all Q32 employees as of the date of this Agreement, setting forth for each employee: job title; classification as exempt or non-exempt for wage and hour purposes; annual base salary, hourly rate or other rates of compensation; bonus potential; full-time or part-time status; date of hire; business location; status (i.e., active or inactive and if inactive, the type of leave and estimated duration); and any visa or work permit status and the date of expiration, if applicable.

(b) Section 3.17(b) of the Q32 Disclosure Schedule contains a complete and accurate list as of the date hereof of all of the independent contractors, consultants, temporary employees, leased employees or other agents employed or used by Q32 and classified by Q32 as other than employees, or compensated other than through wages paid by Q32 through Q32’s payroll department (“Q32 Contingent Workers”), showing for each Q32 Contingent Worker such individual’s engagement date, role in the business, work location, and fee or compensation arrangements.

(c) Neither Q32 nor any of its Subsidiaries is a party to, bound by the terms of, or has a duty to bargain under, any collective bargaining agreement or other Contract with a labor union, works council or labor organization representing any Q32 Associate, and there are no labor unions, works council or labor organizations representing or, to the Knowledge of Q32, purporting to represent or seeking to represent any Q32 Associates, including through the filing of a petition for representation election.

(d) Section 3.17(d) of the Q32 Disclosure Schedule lists all material Q32 Employee Plans.

(e) As applicable with respect to each material Q32 Employee Plan, Q32 has made available to Homology, true and complete copies of (i) the plan document, including all amendments thereto, and in the case of an unwritten Employee Plan, a written description of all material terms thereof, (ii) all related trust instruments or other funding-related documents and insurance contracts, (iii) the summary plan description and each summary of material modifications thereto, (iv) the financial statements for the most recent year for which such financial statements are available (in audited form, if available or required by ERISA) and, where applicable, annual reports with any Governmental Authority (e.g., Form 5500 and all schedules thereto), (v) the most recent IRS determination or opinion letter, (vi) written results of any required compliance testing for the three most recent plan years, and (vii) all material, non-routine notices, filings or correspondence during the past three years with any Governmental Authority.

(f) Each Q32 Employee Plan that is intended to be qualified under Section 401(a) of the Code has received a favorable determination letter or may rely on a favorable opinion letter with respect to such qualified status from the IRS to the effect that such plan is qualified under Section 401(a) of the Code and the related trust is exempt from federal income Taxes under Section 501(a) of the Code. To the Knowledge of Q32, nothing has occurred that would reasonably be expected to cause the loss of the qualified status of any such Q32 Employee Plan or the Tax exempt status of any related trust.

(g) Each Q32 Employee Plan has been established, maintained and operated in compliance, in all material respects, with its terms and all applicable Laws, including, without limitation, the Code and ERISA. No Legal

 

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Proceeding (other than those relating to routine claims for benefits) is pending or, to the Knowledge of Q32, threatened with respect to any Q32 Employee Plan. All material payments and/or contributions required to have been made with respect to all Q32 Employee Plans have been made in accordance with the terms of the applicable Q32 Employee Plan and applicable Law in all material respects and neither Q32 nor any Q32 ERISA Affiliate has any material Liability for any such unpaid contributions with respect to any Q32 Employee Plan.

(h) Neither Q32, any of its Subsidiaries nor any of their ERISA Affiliates maintains, contributes to or is required to contribute to, or has any Liability with respect to (i) any “employee benefit plan” (within the meaning of Section 3(2) of ERISA) that is or was subject to Title IV or Section 302 of ERISA or Section 412 of the Code, (ii) a Multiemployer Plan, (iii) any Multiple Employer Plan, or (iv) any Multiple Employer Welfare Arrangement.

(i) No Q32 Employee Plan provides for medical or other welfare benefits to any service provider beyond termination of service or retirement, other than (i) pursuant to COBRA or an analogous state law requirement (the full cost of which is borne by such Person or such Person’s dependents or beneficiaries) or (ii) continuation coverage through the end of the month in which such termination or retirement occurs.

(j) No Q32 Employee Plan is subject to any law of a foreign jurisdiction outside of the United States.

(k) Each Q32 Employee Plan that constitutes in any part a nonqualified deferred compensation plan within the meaning of Section 409A of the Code has complied in all material respects with Section 409A of the Code, to the extent applicable, and no compensation has been or would reasonably be expected to be includable in the gross income of any Q32 Associate as a result of the operation of Section 409A of the Code.

(l) Q32 and its Subsidiaries are, and since January 1, 2020 have been, in compliance in all material respects with all applicable Laws respecting labor, employment and employment practices, including terms and conditions of employment, worker classification, tax withholding, unemployment compensation, workers’ compensation, prohibited discrimination, harassment, equal employment, fair employment practices, meal and rest periods, work authorization and immigration status, employee safety and health, wages (including overtime wages), pay equity, affirmative action, restrictive covenants, compensation, and hours of work. There are no Legal Proceedings pending or, to the Knowledge of Q32, threatened against Q32 or any of its Subsidiaries relating to any labor or employment matters or any Q32 Associate. Q32 is not a party to a conciliation agreement, consent decree or other agreement or Order with any federal, state, or local agency or Governmental Authority with respect to employment practices.

(m) Since January 1, 2020, (i) Q32 has not taken any action which would constitute a “plant closing”, “collective dismissal”, “group dismissal”, “group termination”, “mass termination”, or “mass layoff” within the meaning of the WARN Act, (ii) issued any written notification of a plant closing or mass layoff required by the WARN Act (nor has Q32 or any of its Subsidiaries has been under any requirement or obligation to issue any such notification), or (iii) incurred any Liability or obligation under the WARN Act that remains unsatisfied.

(n) Since January 1, 2020, there has never been, nor to the Knowledge of Q32 has there been any threat of, any strike, slowdown, work stoppage, lockout, job action, union, organizing activity, question concerning representation or any similar activity or dispute, affecting Q32 or its Subsidiaries. No event has occurred within the past six (6) months, and, to the Knowledge of Q32, no condition or circumstance exists, that would reasonably be expected to give rise to or provide a basis for the commencement of any such strike, slowdown, work stoppage, lockout, job action, union organizing activity, question concerning representation or any similar activity or dispute.

(o) There is no contract, agreement, plan or arrangement to which Q32 or any of its Subsidiaries is a party or by which it is bound to make any payment or compensate any Q32 Associate for Taxes incurred pursuant to the Code, including, but not limited to, Section 4999 or Section 409A of the Code.

 

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(p) Neither the execution and delivery of this Agreement, the shareholder approval of this Agreement, nor the consummation of the Contemplated Transactions (either alone or in conjunction with any other event, including without limitation, a termination of employment) will result in any (i) payment (including severance, forgiveness of indebtedness or otherwise) or benefit becoming due to Q32 Associate, (ii) increase in any benefits or the compensation payable under any Q32 Employee Plan, (iii) acceleration of the time of payment, funding or vesting of any such compensation or benefits or any loan forgiveness, (iv) restriction on the right of Q32 or any of its Subsidiaries or, after the consummation of Contemplated Transactions, the Surviving Corporation, to merge, amend, terminate or transfer any Q32 Employee Plan, or (v) “excess parachute payment” (within the meaning of Section 280G of the Code).

3.18 Environmental Matters. Since January 1, 2020, Q32 and each of its Subsidiaries has complied with all applicable Environmental Laws, which compliance includes the possession by Q32 of all permits and other Governmental Authorizations required under applicable Environmental Laws and compliance with the terms and conditions thereof, except for any failure to be in compliance that, individually or in the aggregate, would not result in a Q32 Material Adverse Effect. Neither Q32 nor any of its Subsidiaries has received since January 1, 2020, any written notice or other communication (in writing or otherwise), whether from a Governmental Authority, citizens group, employee or otherwise, that alleges that Q32 or any of its Subsidiaries is not in compliance with any Environmental law, and, to the Knowledge of Q32, there are no circumstances that may prevent or interfere with Q32’s or any of its Subsidiaries’ compliance with any Environmental Law in the future, except where such failure to comply would not reasonably be expected to have a Q32 Material Adverse Effect. To the Knowledge of Q32: (a) no current or prior owner of any property leased or controlled by Q32 or any of its Subsidiaries has received since January 1, 2020, any written notice or other communication relating to property owned or leased at any time by Q32 or any of its Subsidiaries, whether from a Governmental Authority, citizens group, employee or otherwise, that alleges that such current or prior owner or Q32 or any of its Subsidiaries is not in compliance with or violated any Environmental Law relating to such property and (b) neither Q32 nor any of its Subsidiaries has any material Liability under any Environmental Law.

3.19 Insurance. Q32 has made available to Homology accurate and complete copies of all material insurance policies and all material self-insurance programs and arrangements relating to the business, assets, liabilities and operations of Q32 and its Subsidiaries. Each of such insurance policies is in full force and effect and Q32 and its Subsidiaries are in compliance in all material respects with the terms thereof. Other than customary end of policy notifications from insurance carriers, since January 1, 2020, neither Q32 nor any of its Subsidiaries has received any notice or other communication regarding any actual or possible: (a) cancellation or invalidation of any insurance policy or (b) refusal or denial of any coverage, reservation of rights or rejection of any material claim under any insurance policy. Each of Q32 and its Subsidiaries has provided timely written notice to the appropriate insurance carrier(s) of each Legal Proceeding pending against Q32 or such Subsidiary for which Q32 or such Subsidiary has insurance coverage, and no such carrier has issued a denial of coverage or a reservation of rights with respect to any such Legal Proceeding, or informed Q32 of its intent to do so.

3.20 Transactions with Affiliates. Section 3.20 of the Q32 Disclosure Schedule describes any material transactions or relationships, since January 1, 2020, between, on one hand, Q32 and, on the other hand, any (a) executive officer or director of Q32 or any of such executive officer’s or director’s immediate family members, (b) owner of more than five percent of the voting power of the outstanding shares of Q32 Common Stock or (c) to the Knowledge of Q32, any “related person” (within the meaning of Item 404 of Regulation S-K under the Securities Act) of any such officer, director or owner (other than Q32) in the case of each of (a), (b) or (c) that is of the type that would be required to be disclosed under Item 404 of Regulation S-K under the Securities Act.

3.21 No Financial Advisors. Except as set forth on Section 3.20 of the Q32 Disclosure Schedule, no broker, finder or investment banker is entitled to any brokerage fee, finder’s fee, opinion fee, success fee, transaction fee or other fee or commission in connection with the Contemplated Transactions based upon arrangements made by or on behalf of Q32.

 

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3.22 Privacy and Data Security.

(a) Q32 and its Subsidiaries have complied with all applicable Privacy Laws and the applicable terms of any Q32 Contracts relating to privacy, security, collection or use of Personal Information of any individuals (including clinical trial participants, patients, patient family members, caregivers or advocates, physicians and other health care professionals, clinical trial investigators, researchers, pharmacists) that interact with Q32 or any of its Subsidiaries in connection with the operation of Q32’s and its Subsidiaries’ business, except for such noncompliance as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Q32 Material Adverse Effect. To the Knowledge of Q32, Q32 has implemented and maintains reasonable written policies and procedures, satisfying the requirements of applicable Privacy Laws and Q32 Contracts, concerning the privacy, security, collection and use of Personal Information (the “Q32 Privacy Policies”) and has complied with the same, except for such noncompliance as has not to the Knowledge of Q32 had, and would not reasonably be expected to have, individually or in the aggregate, a Q32 Material Adverse Effect. To the Knowledge of Q32, as of the date hereof, no claims have been asserted or threatened against Q32 by any Person alleging a violation of Privacy Laws, Q32 Privacy Policies and/or the applicable terms of any Q32 Contracts relating to privacy, security, collection or use of Personal Information of any individuals and Q32 has not received written notice of any of the same. To the Knowledge of Q32, there have been no data security incidents, personal data breaches or other adverse events or incidents related to Personal Information or Q32 data in the custody or control of Q32 or any service provider acting on behalf of Q32, in each case where such incident, breach or event would result in a notification obligation to any Person under applicable law or pursuant to the terms of any Q32 Contract.

(b) The information technology assets and equipment of Q32 and its Subsidiaries (collectively, “Q32 IT Systems”) are adequate for, and operate and perform in all material respects as required in connection with the operation of the business of Q32 and its Subsidiaries as currently conducted, and to the Knowledge of Q32, free and clear of all material bugs, errors, defects, Trojan horses, time bombs, malware and other corruptants. Q32 and its Subsidiaries have implemented and maintain commercially reasonable physical, technical and administrative safeguards to protect Personal Information processed by or on behalf of Q32 and its Subsidiaries, any other material confidential information and the integrity and security of Q32 IT Systems used in connection with their businesses, and during the past three years, there have been no breaches, violations, outages or unauthorized uses of or accesses to same, except for those that have been remedied without material cost or Liability or the duty to notify any other Person.

3.23 Concurrent Financing.

(a) Q32 has delivered to Homology true, correct and complete copies of all definitive agreements related to the Concurrent Financing, including the Subscription Agreement, pursuant to which the Purchasers (as defined in the Subscription Agreement) party thereto (collectively, the “Purchasers”) have agreed, subject to the terms and conditions set forth therein, to purchase the number of shares of Q32 Common Stock set forth therein in connection with the transactions contemplated by this Agreement. The Subscription Agreement has not been amended or modified prior to the date of this Agreement and as of the date hereof, no such amendment or modification is contemplated (other than amendments or modifications that are permitted by Section 5.27), and as of the date hereof, the respective obligations and commitments contained in the Subscription Agreement have not been withdrawn or rescinded in any respect.

(b) As of the date hereof, the Subscription Agreement is in full force and effect and is the legal, valid, binding and enforceable obligation of Q32, and, to the Knowledge of Q32, each of the Purchasers. There are no conditions precedent or other contingencies related to the funding of the full amount of the Concurrent Financing, other than as expressly set forth in the Subscription Agreement. As of the date hereof, no event has occurred which, with or without notice, lapse of time or both, would reasonably be expected to constitute a default or breach on the part of Q32 or, to the Knowledge of Q32, any Purchaser under the Subscription Agreement. As of the date hereof, Q32 has no reason to believe that any of the conditions to the Concurrent Financing as contemplated by the Subscription Agreement will not be satisfied.

 

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3.24 No Other Representations or Warranties. Q32 hereby acknowledges and agrees that, except for the representations and warranties contained in this Agreement, neither Homology nor any other person on behalf of Homology makes any express or implied representation or warranty with respect to Homology or with respect to any other information provided to Q32, any of its stockholders or any of their respective Affiliates in connection with the Contemplated Transactions, and (subject to the express representations and warranties of Homology set forth in Article IV (in each case as qualified and limited by the Homology Disclosure Schedule)) none of Q32, or any of its Representatives or stockholders, has relied on any such information (including the accuracy or completeness thereof).

ARTICLE IV

REPRESENTATIONS AND WARRANTIES OF HOMOLOGY AND MERGER SUB

Except (i) as set forth in the written disclosure schedule delivered by Homology to Q32 (the “Homology Disclosure Schedule”) or (ii) as disclosed in the Homology SEC Documents filed with the SEC on or before the day that is one (1) Business Day prior to the date hereof and publicly available on the SEC’s Electronic Data Gathering Analysis and Retrieval system (but (A) without giving effect to any amendment thereof filed with, or furnished to the SEC on or after the date hereof and (B) excluding any disclosures contained under the heading “Risk Factors” and any disclosure of risks included in any “forward-looking statements” disclaimer or in any other section to the extent they are forward-looking statements or cautionary, predictive or forward-looking in nature), it being understood that any matter disclosed in the Homology SEC Documents shall not be deemed disclosed for purposes of Section 4.1(a), 4.1(b) or 4.3, Homology and Merger Sub represent and warrant to Q32 as follows:

4.1 Due Organization; Subsidiaries.

(a) Each of Homology and its Subsidiaries (including Merger Sub) is a corporation or other legal entity duly incorporated or otherwise organized, validly existing and in good standing under the Laws of the jurisdiction of its incorporation or organization and has all necessary power and authority: (i) to conduct its business in the manner in which its business is currently being conducted, (ii) to own or lease and use its property and assets in the manner in which its property and assets are currently owned or leased and used and (iii) to perform its obligations under all Contracts by which it is bound. Since the date of its formation, Merger Sub has not engaged in any activities other than in connection with or as contemplated by this Agreement. All of Homology’s Subsidiaries are wholly owned by Homology.

(b) Each of Homology and its Subsidiaries is licensed and qualified to do business, and is in good standing (to the extent applicable in such jurisdiction), under the Laws of all jurisdictions where the nature of its business in the manner in which its business is currently being conducted requires such licensing or qualification other than in jurisdictions where the failure to be so qualified individually or in the aggregate would not be reasonably expected to have a Homology Material Adverse Effect.

(c) Except as set forth on Section 4.1(c) of the Homology Disclosure Schedule, Homology has no Subsidiaries other than Merger Sub and Homology does not directly or indirectly own any capital stock of, or any equity ownership or profit sharing interest of any nature in, or control directly or indirectly, any other Entity other than Merger Sub. Homology is not and has not otherwise been, directly or indirectly, a party to, member of or participant in any partnership, joint venture or similar business entity. Homology has not agreed and is not obligated to make, nor is Homology bound by any Contract under which it may become obligated to make, any future investment in or capital contribution to any other Entity. Homology has not, at any time, been a general partner of, and has not otherwise been liable for any of the debts or other obligations of, any general partnership, limited partnership or other Entity.

 

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4.2 Organizational Documents. Homology has delivered to Q32 accurate and complete copies of the Organizational Documents of Homology and Merger Sub. Neither Homology nor Merger Sub is in breach or violation of its Organizational Documents in any material respect.

4.3 Authority; Binding Nature of Agreement. Each of Homology and Merger Sub has all necessary corporate power and authority to enter into and to perform its obligations under this Agreement and to consummate the Contemplated Transactions. The Homology Board (at meetings duly called and held) has: (a) determined that the Contemplated Transactions are fair to, advisable and in the best interests of Homology and its stockholders, (b) approved and declared advisable this Agreement and the Contemplated Transactions, including the issuance of shares of Homology Common Stock to the stockholders of Q32 pursuant to the terms of this Agreement and (c) determined to recommend the Homology Board Recommendation to the stockholders of Homology, and (d) determined to approve and recommend the forms of the Charter Amendment Proposals to the stockholders of Homology as promptly as practicable after the forms thereof are mutually agreed to by Homology and Q32. The Merger Sub Board (by unanimous written consent) has: (x) determined that the Contemplated Transactions are fair to, advisable, and in the best interests of Merger Sub and its sole stockholder, (y) deemed advisable and approved this Agreement and the Contemplated Transactions and (z) determined to recommend, upon the terms and subject to the conditions set forth in this Agreement, that the stockholder of Merger Sub vote to adopt this Agreement and thereby approve the Contemplated Transactions. This Agreement has been duly executed and delivered by Homology and Merger Sub and, assuming the due authorization, execution and delivery by Q32, constitutes the legal, valid and binding obligation of Homology and Merger Sub, enforceable against each of Homology and Merger Sub in accordance with its terms, subject to the Enforceability Exceptions.

4.4 Vote Required. The affirmative vote of a majority of the votes cast at the Homology Stockholder Meeting is the only vote of the holders of any class or series of Homology Common Stock necessary to approve this Agreement and the Contemplated Transactions, including the issuance of the shares of Homology Common Stock to the stockholders of Q32 in the Merger pursuant to the terms of this Agreement (the “Required Homology Stockholder Vote”) .

4.5 Non-Contravention; Consents.

(a) Subject to obtaining the Required Homology Stockholder Vote and the filing of the Certificate of Merger required by Delaware Law, neither (x) the execution, delivery or performance of this Agreement by Homology or Merger Sub, nor (y) the consummation of the Contemplated Transactions, will directly or indirectly (with or without notice or lapse of time):

(i) contravene, conflict with or result in a violation of any of the provisions of the Organizational Documents of Homology or its Subsidiaries;

(ii) contravene, conflict with or result in a material violation of, or give any Governmental Authority or other Person the right to challenge the Contemplated Transactions or to exercise any remedy or obtain any relief under, any Law or any Order to which Homology or its Subsidiaries, or any of the assets owned or used by Homology or its Subsidiaries, is subject;

(iii) contravene, conflict with or result in a material violation of any of the terms or requirements of, or give any Governmental Authority the right to revoke, withdraw, suspend, cancel, terminate or modify, any Governmental Authorization that is held by Homology or its Subsidiaries or that otherwise relates to the business of Homology, or any of the assets owned, leased or used by Homology;

(iv) contravene, conflict with or result in a violation or breach of, or result in a default under, any provision of any Homology Material Contract, or give any Person the right to: (A) declare a default or exercise any remedy under any Homology Material Contract, (B) any material payment, rebate, chargeback, penalty or change in delivery schedule under any such Homology Material Contract, (C) accelerate the maturity or performance of any Homology Material Contract or (D) cancel, terminate or modify any term of

 

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any Homology Material Contract, except in the case of any nonmaterial breach, default, penalty or modification; or

(v) result in the imposition or creation of any Encumbrance upon or with respect to any asset owned or used by Homology or its Subsidiaries (except for Permitted Encumbrances).

(b) Except for (i) any Consent set forth on Section 4.5 of the Homology Disclosure Schedule under any Homology Contract, (ii) the Required Homology Stockholder Vote, (iii) the filing of the Certificate of Merger with the Secretary of State of the State of Delaware pursuant to Delaware Law and (iv) such consents, waivers, approvals, orders, authorizations, registrations, declarations and filings as may be required under applicable federal and state securities laws, neither Homology nor any of its Subsidiaries was, is or will be required to make any filing with or give any notice to, or to obtain any Consent from, any Person in connection with (x) the execution, delivery or performance of this Agreement or (y) the consummation of the Contemplated Transactions.

(c) The Homology Board and the Merger Sub Board have taken and will take all actions necessary to ensure that the restrictions applicable to business combinations contained in Section 203 of Delaware Law are, and will be, inapplicable to the execution, delivery and performance of this Agreement and to the consummation of the Contemplated Transactions. No other state takeover statute or similar Law applies or purports to apply to the Merger, this Agreement or any of the other Contemplated Transactions.

4.6 Capitalization.

(a) The authorized capital stock of Homology consists of (i) 200,000,000 shares of common stock, par value $0.0001 per share (“Homology Common Stock”), of which 57,934,332 shares have been issued and are outstanding as of November 10, 2023 and (ii) 10,000,000 shares of preferred stock, par value $0.0001 per share (“Homology Preferred Stock”), of which no shares have been issued and are outstanding as of November 10, 2023 (the “Capitalization Date”). Homology does not hold any shares of its capital stock in its treasury.

(b) All of the outstanding shares of Homology Common Stock have been duly authorized and validly issued, and are fully paid and nonassessable and are free of any Encumbrances other than under applicable securities Laws. None of the outstanding shares of Homology Common Stock is entitled or subject to any preemptive right, right of participation, right of maintenance or any similar right and none of the outstanding shares of Homology Common Stock is subject to any right of first refusal in favor of Homology. Except as contemplated herein, there is no Homology Contract relating to the voting or registration of, or restricting any Person from purchasing, selling, pledging or otherwise disposing of (or granting any option or similar right with respect to), any shares of Homology Common Stock. Homology is not under any obligation, nor is it bound by any Contract pursuant to which it may become obligated, to repurchase, redeem or otherwise acquire any outstanding shares of Homology Common Stock or other securities. Section 4.6(b) of the Homology Disclosure Schedule accurately and completely lists all repurchase rights held by Homology with respect to shares of Homology Common Stock (including shares issued pursuant to the exercise of options) and specifies which of those repurchase rights are currently exercisable.

(c) Except for the Homology Equity Plans and the Homology Options and Homology Restricted Stock Unit Awards granted thereunder, Homology does not have any stock incentive plan or any other plan, program, agreement or arrangement providing for any equity or equity-based compensation for any Person and there were no other equity or equity-based awards outstanding as of the date of this Agreement. As of the Capitalization Date, Homology has reserved 13,363,775 shares of Homology Common Stock for issuance under the Homology Equity Plans, of which 416,819 shares have been issued and are outstanding pursuant to the exercise of Homology Options or settlement of Homology Restricted Stock Units, 10,225,976 shares are subject to outstanding Homology Options, 460,388 shares are subject to outstanding Homology Restricted Stock Unit Awards, and 1,978,793 shares remain available for future grant pursuant to the Homology Equity Plans.

 

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Section 4.6(c) of the Homology Disclosure Schedule sets forth a true and complete list, as of November 1, 2023, of each outstanding Homology Option and Homology Restricted Stock Unit award, including: (i) the name of the holder, (ii) the number of shares of Homology Common Stock subject to such Homology Option and/or Homology Restricted Stock Unit Award, (iii) the exercise price of each Homology Option, (iv) the date of grant, (v) the applicable vesting schedule, including any acceleration provisions and the number of vested and unvested shares, (vi) the expiration date, as applicable, and (vii) whether the Homology Option is intended to be an “incentive stock option” (as defined in the Code) or a non-qualified stock option. Homology has made available to Q32 accurate and complete copies of the following (except for such documents that are filed as an exhibit to a Homology SEC Document): (A) the standard form of agreement evidencing Homology Options and Homology Restricted Stock Unit Awards; and (B) each agreement evidencing a Homology Option or Homology Restricted Stock Unit Award that does not conform in all material respects to the standard form agreement.

(d) Except as set forth on Section 4.6(c) of the Homology Disclosure Schedule, there is no: (i) outstanding subscription, option, call, warrant or right (whether or not currently exercisable) to acquire any shares of the capital stock or other securities of Homology, (ii) outstanding security, instrument or obligation that is or may become convertible into or exchangeable for any shares of the capital stock or other securities of Homology, (iii) stockholder rights plan (or similar plan commonly referred to as a “poison pill”) or Contract under which Homology is or may become obligated to sell or otherwise issue any shares of its capital stock or any other securities or (iv) condition or circumstance that may give rise to or provide a basis for the assertion of a claim by any Person to the effect that such Person is entitled to acquire or receive any shares of capital stock or other securities of Homology.

(e) All outstanding shares of Homology Common Stock and other securities of Homology have been issued and granted in material compliance with (i) all applicable securities laws and other applicable Law and (ii) all requirements set forth in applicable Contracts.

4.7 SEC Filings; Financial Statements.

(a) Homology has filed or furnished, as applicable, on a timely basis all forms, statements, certifications, reports and documents required to be filed or furnished by it with the SEC under the Exchange Act or the Securities Act since January 1, 2021 (the “Homology SEC Documents”). As of the time it was filed with the SEC (or, if amended or superseded by a filing prior to the date of this Agreement, then on the date of such filing), each of the Homology SEC Documents complied in all material respects with the applicable requirements of the Securities Act or the Exchange Act (as the case may be) and as of the time they were filed, none of the Homology SEC Documents contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. The certifications and statements required by (i) Rule 13a-14 under the Exchange Act and (ii) 18 U.S.C. §1350 (Section 906 of the Sarbanes-Oxley Act) relating to the Homology SEC Documents (collectively, the “Homology Certifications”) are accurate and complete and comply as to form and content with all applicable Laws. As used in this Section 4.7, the term “file” and variations thereof shall be broadly construed to include any manner in which a document or information is furnished, supplied or otherwise made available to the SEC.

(b) The financial statements (including any related notes) contained or incorporated by reference in the Homology SEC Documents: (i) complied as to form in all material respects with the Securities Act and the Exchange Act, as applicable, and the published rules and regulations of the SEC applicable thereto, (ii) were prepared in accordance with GAAP (except as may be indicated in the notes to such financial statements or, in the case of unaudited financial statements, as permitted by Form 10-Q of the SEC, and except that the unaudited financial statements are subject to normal and recurring year-end adjustments that are not reasonably expected to be material in amount) applied on a consistent basis unless otherwise noted therein throughout the periods indicated and (iii) fairly present, in all material respects, the financial position of Homology as of the respective dates thereof and the results of operations and cash flows of Homology for the periods covered thereby. Other

 

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than as expressly disclosed in the Homology SEC Documents filed prior to the date hereof, there has been no material change in Homology’s accounting methods or principles that would be required to be disclosed in Homology’s financial statements in accordance with GAAP. The books of account and other financial records of Homology and each of its Subsidiaries are true and complete in all material respects.

(c) Homology’s auditor has at all times since the date of enactment of the Sarbanes-Oxley Act been: (i) a registered public accounting firm (as defined in Section 2(a)(12) of the Sarbanes-Oxley Act), (ii) to the Knowledge of Homology, “independent” with respect to Homology within the meaning of Regulation S-X under the Exchange Act and (iii) to the Knowledge of Homology, in compliance with subsections (g) through (l) of Section 10A of the Exchange Act and the rules and regulations promulgated by the SEC and the Public Company Accounting Oversight Board thereunder.

(d) Except as set forth on Section 4.7(d) of the Homology Disclosure Schedule, Homology has not received any comment letter from the SEC or the staff thereof or any correspondence from Nasdaq or the staff thereof relating to the delisting or maintenance of listing of Homology Common Stock on Nasdaq. Homology has not disclosed any unresolved comments in the Homology SEC Documents.

(e) There have been no formal internal investigations regarding financial reporting or accounting policies and practices discussed with, reviewed by or initiated at the direction of the chief executive officer, chief financial officer, or general counsel of Homology, the Homology Board or any committee thereof, other than ordinary course audits or reviews of accounting policies and practices or internal controls required by the Sarbanes-Oxley Act.

(f) Except as set forth on Section 4.7(f) of the Homology Disclosure Schedule, Homology is in compliance in all material respects with the applicable provisions of the Sarbanes-Oxley Act, the Exchange Act and the applicable listing and governance rules and regulations of Nasdaq.

(g) Homology maintains a system of internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-l5(f) of the Exchange Act) that is sufficient to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP, including policies and procedures sufficient to provide reasonable assurance (i) that Homology maintains records that in reasonable detail accurately and fairly reflect Homology’s transactions and dispositions of assets, (ii) that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, (iii) that receipts and expenditures are made only in accordance with authorizations of management and the Homology Board and (iv) regarding prevention or timely detection of the unauthorized acquisition, use or disposition of Homology’s assets that could have a material effect on Homology’s financial statements. Homology has evaluated the effectiveness of Homology’s internal control over financial reporting and, to the extent required by applicable Law, presented in any applicable Homology SEC Document that is a report on Form 10-K or Form 10-Q (or any amendment thereto) its conclusions about the effectiveness of the internal control over financial reporting as of the end of the period covered by such report or amendment based on such evaluation. Homology has disclosed to Homology’s auditors and the Audit Committee of the Homology Board (and made available to Homology a summary of the significant aspects of such disclosure) (A) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting that are reasonably likely to adversely affect Homology’s ability to record, process, summarize and report financial information and (B) any known fraud, whether or not material, that involves management or other employees who have a significant role in Homology or its Subsidiaries’ internal control over financial reporting. Except as disclosed in the Homology SEC Documents filed prior to the date hereof, Homology’s internal control over financial reporting is effective and Homology has not identified any material weaknesses in the design or operation of Homology’s internal control over financial reporting.

(h) Homology’s “disclosure controls and procedures” (as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act) are designed to ensure that all information (both financial and nonfinancial) required to be

 

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disclosed by Homology in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC, and that all such information is accumulated and communicated to Homology’s principal executive officer and principal financial officer as appropriate to allow timely decisions regarding required disclosure and to make the Homology Certifications and such disclosure controls and procedures are effective. Homology has carried out evaluation of the effectiveness of its disclosure controls and procedures as required by Rule 13a-l5 of the Exchange Act.

(i) Homology has not been and is not currently a “shell company” as defined under Section 12b-2 of the Exchange Act.

4.8 Absence of Changes. Except as set forth on Section 4.8 of the Homology Disclosure Schedule, since January 1, 2023, Homology and its Subsidiaries have conducted its business only in the Ordinary Course of Business (except for the execution and performance of this Agreement and the discussions, negotiations and transactions related thereto) and there has not been any (a) Homology Material Adverse Effect or (b) action, event or occurrence that would have required consent of Homology pursuant to Section 5.2 of this Agreement had such action, event or occurrence taken place after the execution and delivery of this Agreement.

4.9 Absence of Undisclosed Liabilities. Neither Homology nor any of its Subsidiaries has any Liability of a type required to be reflected or reserved for on a balance sheet prepared in accordance with GAAP, except for: (a) Liabilities disclosed, reflected or reserved against in the Homology Balance Sheet, (b) normal and recurring current Liabilities that have been incurred by Homology or its Subsidiaries since the date of the Homology Balance Sheet in the Ordinary Course of Business (none of which relates to any breach of contract, breach of warranty, tort, infringement, or violation of Law), (c) Liabilities for performance of obligations of Homology or any of its Subsidiaries under Homology Contracts, (d) Liabilities incurred in connection with the Contemplated Transactions and the Subscription Agreement and (e) Liabilities listed in Section 4.9 of the Homology Disclosure Schedule.

4.10 Title to Assets. Each of Homology and its Subsidiaries owns, and has good and valid title to, or, in the case of leased properties and assets, valid leasehold interests in, all tangible properties or tangible assets and equipment used or held for use in its business or operations or purported to be owned by it, including: (a) all tangible assets reflected on the Homology Balance Sheet and (b) all other tangible assets reflected in the books and records of Homology as being owned by Homology. All of such assets are owned or, in the case of leased assets, leased by Homology or any of its Subsidiaries free and clear of any Encumbrances, other than Permitted Encumbrances.

4.11 Real Property; Leasehold. Neither Homology nor any of its Subsidiaries owns or has ever owned any real property. Homology has made available to Q32 (a) an accurate and complete list of all real properties with respect to which Homology directly or indirectly holds a valid leasehold interest as well as any other real estate that is in the possession of or leased by Homology or any of its Subsidiaries and (b) copies of all leases under which any such real property is possessed (the “Homology Real Estate Leases”), each of which is in full force and effect, with no existing material default thereunder.

4.12 Intellectual Property.

(a) Section 4.12(a) of the Homology Disclosure Schedule is an accurate, true and complete listing of all Homology Registered IP, including for each item (i) the record owner (and name of any other Person with an ownership interest in such item of Homology Registered IP, if any), jurisdiction (or, with respect to domain names, the applicable registrar), status, date and registration or application number of each item, as applicable, (ii) the name of the record owner and any other Person that has an ownership interest in such item of Homology Registered IP, and the nature of such ownership interest, and (iii) any actions that are required to be taken within 180 days of the date hereof for any Homology Registered IP, including the payment of any registration, maintenance or renewal fees or the filing of or response to any documents, applications or certificates, for the

 

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purposes of prosecuting, obtaining, perfecting, maintaining or renewing any Homology Registered IP. Section 4.12(a) of the Homology Disclosure Schedule also sets forth, as of the date of this Agreement, a list of all internet domain names with respect to which Homology or any of its Subsidiaries are the registrant and, with respect to each domain name, the record owner of such domain name and if different, the legal and beneficial owner(s) of such domain name and the applicable domain name registrar.

(b) Section 4.12(b) of the Homology Disclosure Schedule accurately identifies (all Homology Contracts pursuant to which any material Homology IP Rights are licensed to Homology (other than (A) any non-customized software that (1) is so licensed solely in executable or object code form pursuant to a nonexclusive, internal use software license and other Intellectual Property associated with such software and (2) is not incorporated into, or material to the development, manufacturing, or distribution of, any of Homology’s or its Subsidiaries’ products or services, (B) any Intellectual Property licensed on a nonexclusive basis ancillary to the purchase or use of equipment, reagents or other materials, (C) any confidential information provided under confidentiality agreements and (D) agreements between Homology or its Subsidiaries and their respective employees in Homology’s standard form thereof). To the Knowledge of Homology, each Homology Contract listed in Section 4.12(b) of the Homology Disclosure Schedule is in full force and effect and constitutes a legal, valid, and binding obligation of Homology, its Subsidiaries and each other party thereto, and is enforceable against Homology, its Subsidiaries and each other party thereto in accordance with its terms. To the Knowledge of Homology, neither Homology, its Subsidiaries, nor any other party to any Homology Contract listed in Section 4.12(b) of the Homology Disclosure Schedule has been or is, or has been or is alleged to be, in material default under, or has provided or received any notice of breach under, or intention to terminate (including by non-renewal), any Homology Contract listed in Section 4.12(b) of the Homology Disclosure Schedule, except as would not reasonably be expected to have, individually or in the aggregate, a Homology Material Adverse Effect.

(c) Except for instances that would not reasonably be expected to have, individually or in the aggregate, a Homology Material Adverse Effect, Section 4.12(c) of the Homology Disclosure Schedule accurately identifies each Homology Contract pursuant to which any Person has been granted any license under, or otherwise has received or acquired any right (whether or not currently exercisable) or interest in, any Homology IP Rights (other than (i) any confidential information provided under confidentiality agreements and (ii) any Homology IP Rights nonexclusively licensed to academic collaborators, suppliers or service providers for the sole purpose of enabling such academic collaborator, supplier or service providers to provide services for Homology’s or its Subsidiaries’ benefit). To the Knowledge of Homology, each Homology Contract listed in Section 4.12(c) of the Homology Disclosure Schedule is in full force and effect and constitutes a legal, valid, and binding obligation of Homology, its Subsidiaries and each other party thereto, and is enforceable against Homology, its Subsidiaries and each other party thereto in accordance with its terms. Neither Homology, its Subsidiaries nor, to the Knowledge of Homology, any other party to any Homology Contract listed in Section 4.12(c) of the Homology Disclosure Schedule has provided or received any written notice or allegation of breach under, or intention to terminate (including by non-renewal), any Homology Contract listed in Section 4.12(c) of the Homology Disclosure Schedule.

(d) Except as identified on Section 4.12(d) of the Homology Disclosure Schedule, neither Homology nor any of its Subsidiaries is bound by, no Homology Owned IP Rights are subject to, and to the Knowledge of Homology, no Homology Licensed IP Rights are subject to, any Contract containing any covenant or other provision that in any way limits or restricts the ability of Homology or any of its Subsidiaries to use, exploit, assert, or enforce any Homology IP Rights anywhere in the world, except as would not reasonably be expected to have, individually or in the aggregate, a Homology Material Adverse Effect.

(e) Homology or one of its Subsidiaries exclusively owns all right, title, and interest to and in the Homology IP Rights (other than (i) Homology Licensed IP Rights, or co-owned rights each as identified in Section 4.12(c) of the Homology Disclosure Schedule, (ii) any non-customized software that (A) is licensed to Homology or its Subsidiaries solely in executable or object code form pursuant to a nonexclusive, internal use software license and other Intellectual Property associated with such software and (B) is not incorporated into, or material to the

 

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development, manufacturing, or distribution of, any of Homology or its Subsidiaries’ products or services and (iii) any Intellectual Property licensed on a nonexclusive basis ancillary to the purchase or use of equipment, reagents or other materials), in each case, free and clear of any Encumbrances (other than Permitted Encumbrances).

(f) To the Knowledge of Homology, (i) all documents and instruments necessary to register or apply for or renew registration of Homology Registered IP owned by Homology, and (ii) all documents and instruments necessary to register or apply for or renew registration of Homology Registered IP exclusively licensed to Homology, have been validly executed, delivered, and filed in a timely manner with the appropriate Governmental Authority. To the Knowledge of Homology, (A) Homology has filed all statements of use and paid all renewal and maintenance fees, annuities and other fees with respect to the Homology Registered IP owned by Homology, and (B) Homology has executed all documents and instruments necessary to register or apply for or renew registration of Homology Registered IP exclusively licensed to Homology, in each case (A) and (B), that are due or payable as of the date of this Agreement.

(g) Except for instances that would not reasonably be expected to have, individually or in the aggregate, a Homology Material Adverse Effect, to the Knowledge of Homology each Person who is or was an employee, contractor or consultant of Homology or any of its Subsidiaries and who is or was involved in the creation, discovery, reduction to practice or development of any Intellectual Property for Homology or any of its Subsidiaries has signed a valid, enforceable written agreement containing a present assignment of all right, title and interest in and to such Intellectual Property to Homology or such Subsidiary and confidentiality provisions protecting trade secrets and confidential information of Homology and its Subsidiaries.

(h) To the Knowledge of Homology, no current or former member, officer, director, or employee of Homology or any of its Subsidiaries has any claim, right (whether or not currently exercisable), or interest to or in any Homology IP Rights purported to be owned by Homology. To the Knowledge of Homology, no employee of Homology or any of its Subsidiaries is (A) bound by or otherwise subject to any Contract restricting him or her from performing his or her duties for Homology or such Subsidiary or (B) in breach of any Contract with any former employer or other Person concerning Homology IP Rights purported to be owned by Homology or such Subsidiary or confidentiality provisions protecting trade secrets and confidential information comprising Homology IP Rights purported to be owned by Homology or such Subsidiary.

(i) No funding, facilities, or personnel of any Governmental Authority were used, directly or indirectly, to develop or create, in whole or in part, any Homology Owned IP Rights, or, to the Knowledge of Homology, any Homology Licensed IP Rights, and no educational institution has any right to, or right to royalties for, or to impose any requirement on the manufacture or commercialization of any product incorporating, any Homology Owned IP Rights, or, to the Knowledge of Homology, any Homology Licensed IP Rights. To the Knowledge of Homology, no Governmental Authority has any right to (including any “step-in” or “march-in” rights with respect to), ownership of, commercialization of, or right to royalties or other payments for any Homology Owned IP Rights, or, to the Knowledge of Homology, any Licensed IP Rights. Without limiting the generality of the foregoing, to the Knowledge of Homology, no invention claimed or covered by any Patent within the Homology Owned IP Rights, or, to the Knowledge of Homology, any Homology Licensed IP Rights, (A) was conceived or reduced to practice in connection with any research activities funded, in whole or in part, by the federal government of the United States or any agency thereof, (B) is a “subject invention” as that term is described in 35 U.S.C. Section 201(e), or (C) is otherwise subject to the provisions of the Bayh-Dole Act or any similar Law of any other jurisdiction, including with respect to any Patents that are part of the Homology IP Rights.

(j) Homology and each of its Subsidiaries has taken reasonable steps to maintain the confidentiality of and otherwise protect, maintain and enforce its rights in all proprietary information that Homology or such Subsidiary holds, or purports to hold, as confidential or a trade secret. To the Knowledge of Homology, neither Homology nor any of its Subsidiaries has made any of its trade secrets or other material confidential or proprietary information that it intended to maintain as confidential information available to any other Person except pursuant

 

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to written agreements requiring such Person to maintain the confidentiality of such trade secrets or confidential information. To the Knowledge of Homology, there have been no material security breaches, outages, violations or unauthorized access to any of the proprietary information that Homology or any of its Subsidiaries holds, or purports to hold, as confidential or a trade secret, except as would not reasonably be expected to have, individually or in the aggregate, a Homology Material Adverse Effect.

(k) Neither Homology nor any of its Subsidiaries has assigned or otherwise transferred ownership of, or agreed to assign or otherwise transfer ownership of, any Homology IP Rights, to any other Person.

(l) To the Knowledge of Homology, neither Homology nor any of its Subsidiaries has taken or failed to take any action that could be reasonably expected to result in the abandonment, invalidity, cancellation, forfeiture, relinquishing, invalidation or unenforceability of any Homology IP Rights (including with respect to any trademark, a failure to exercise adequate quality controls or an assignment in gross without the accompanying goodwill). To the Knowledge of Homology, each item of Homology IP Right has been duly maintained and is not expired, abandoned or cancelled. To the Knowledge of Homology, each of the Patents included in the Homology IP Rights identifies each and every inventor of the claims thereof as determined in accordance with the applicable laws of the jurisdiction in which such Patent is issued or pending. To the Knowledge of Homology, neither Homology nor any of its Subsidiaries has engaged in patent or copyright misuse or any fraud or inequitable conduct in connection with any Homology IP Right. To the Knowledge of Homology, each of Homology and its Subsidiaries and their respective patent counsel have complied with its duty of candor and disclosure and have made no material misrepresentations in the filings submitted to the applicable Governmental Authorities with respect to all Patents included in the Homology IP Rights for which Homology or any of its Subsidiaries is responsible for prosecuting.

(m) To the Knowledge of Homology, the Homology IP Rights constitute all Intellectual Property necessary for Homology to conduct its business as currently conducted or proposed to be conducted; provided, however, that the foregoing representation is not a representation with respect to non-infringement of Intellectual Property.

(n) Homology has delivered, or made available to Q32, a complete and accurate copy of all material Homology IP Rights Agreements.

(o) To the Knowledge of Homology, the manufacture, marketing, offering for sale, sale, importation, use or intended use or other disposal of any product as currently sold or under development by Homology does not violate any license or agreement between Homology or its Subsidiaries and any third party in any material respect, and, to the Knowledge of Homology, does not infringe or misappropriate any valid and issued Patent or other Intellectual Property of any other Person, which infringement or misappropriation would reasonably be expected to have a Homology Material Adverse Effect. To the Knowledge of Homology, no third party is infringing upon any Patents owned by Homology within the Homology IP Rights, or otherwise violating any Homology IP Rights Agreement.

(p) As of the date of this Agreement, neither Homology nor any of its Subsidiaries is a party to any Legal Proceeding (including, but not limited to, opposition, interference or other proceeding in any patent or other government office) contesting the validity, ownership or right to use, sell, offer for sale, license or dispose of any Homology IP Rights. None of the Homology IP Rights, and to the Knowledge of Homology, none of the Homology Licensed IP Rights, have been adjudged invalid or unenforceable in whole or part, and all Homology Owned IP Rights, and to the Knowledge of Homology, all Homology Licensed IP Rights, are in full force and effect. No Patent within the Homology Registered IP owned by Homology, or to the Knowledge of Homology, no Patents within the Homology Registered IP exclusively licensed to Homology, have been subject to any interference, derivation, reexamination (including ex parte reexamination, inter partes reexamination, inter partes review, or post grant review), reissue, cancellation, opposition, claim, allegation or other action, including any proceeding in which the scope, validity, inventorship, ownership or enforceability of any such Patent is being, has been, or could reasonably be expected to be, contested or challenged. Neither Homology nor any of its

 

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Subsidiaries have received any written notice asserting that any Homology IP Rights or the proposed use, sale, offer for sale, license or disposition of products, methods, or processes claimed or covered thereunder infringes or misappropriates or violates the rights of any other Person or that Homology or any of its Subsidiaries have otherwise infringed, misappropriated or otherwise violated any Intellectual Property of any Person.

(q) To the Knowledge of Homology, no trademark (whether registered or unregistered) or trade name owned, used, or applied for by Homology conflicts or interferes with any trademark (whether registered or unregistered) or trade name owned, used, or applied for by any other Person except as would not have a Homology Material Adverse Effect. To the Knowledge of Homology, none of the goodwill associated with or inherent in any trademark (whether registered or unregistered) in which Homology or its Subsidiaries has or purports to have an ownership interest has been impaired as determined by Homology in accordance with GAAP. Section 4.12(q) of the Homology Disclosure Schedule sets forth all material unregistered trademarks included in the Homology IP Rights.

(r) Except (i) as would reasonably be expected to have a Homology Material Adverse Effect, (ii) as may be set forth in Section 4.12(b) or 4.12(c) of the Homology Disclosure Schedule or (iii) as contained in license, distribution or service agreements entered into in the Ordinary Course of Business by Homology, to the Knowledge of Homology, (A) neither Homology nor any of its Subsidiaries is bound by any Contract to indemnify, defend, hold harmless, or reimburse any other Person with respect to any Intellectual Property infringement, misappropriation, or similar claim which is material to Homology or any of its Subsidiaries, taken as a whole and (B) neither Homology nor any of its Subsidiaries has ever assumed, or agreed to discharge or otherwise take responsibility for, any existing or potential liability of another Person for infringement, misappropriation, or violation of any Intellectual Property right, which assumption, agreement or responsibility remains in force as of the date of this Agreement.

(s) To the Knowledge of Homology, neither Homology nor any of its Subsidiaries is party to any Contract that, as a result of such execution, delivery and performance of this Agreement, will (i) cause the grant, assignment or transfer to any other third party of any license or other right to or in any Homology IP Rights, (ii) result in breach of, default under termination of, or acceleration or modification of such Contract with respect to any Homology IP Rights, (iii) alter, encumber impair or extinguish, or result in any Encumbrance with respect to the right of Homology or the Surviving Corporation and its Subsidiaries to use, sell or license or enforce any Homology IP Rights or portion thereof or (iv) result in Homology or any of its Subsidiaries being bound by or subject to any exclusivity obligations, non-compete or other restrictions on the operation or scope of their respective businesses, or to any obligation to grant any rights in or to any Homology IP Rights, except, in each of (i), (ii), (iii) and (iv), for the occurrence of any such grant or impairment that would not individually or in the aggregate, reasonably be expected to result in a Homology Material Adverse Effect.

4.13 Agreements, Contracts and Commitments.

(a) Section 4.13 of the Homology Disclosure Schedule lists the following Homology Contracts in effect as of the date of this Agreement other than the Subscription Agreement (each, a “Homology Material Contract” and collectively, the “Homology Material Contracts”):

(i) each Homology Contract that is a collective bargaining agreement or other agreement or arrangement with any labor union, works council or labor organization;

(ii) each Homology Contract for the employment or engagement of any individual on an employee, consulting or other basis that provides for annual base compensation in excess of $200,000;

(iii) each Homology Contract with any Homology Associate that provides for retention, change in control, transaction or other similar payments or benefits, whether or not payable as a result of the Contemplated Transactions;

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(v) each Homology Contract containing (A) any covenant limiting the freedom of Homology or any of its Subsidiaries to engage in any line of business or compete with any Person, or limiting the development, manufacture, or distribution of Homology’s products or services, (B) any most-favored pricing arrangement, (C) any exclusivity provision or (D) any non-solicitation provision;

(vi) each Homology Contract (A) pursuant to which any Person granted Homology an exclusive license under any Intellectual Property, or (B) pursuant to which Homology granted any Person an exclusive license under any Homology IP Rights;

(vii) each Homology Contract relating to capital expenditures and requiring payments after the date of this Agreement in excess of $500,000 pursuant to its express terms and not cancelable without penalty;

(viii) each Homology Contract relating to the disposition or acquisition of material assets or any ownership interest in any Entity, in each case, involving payments in excess of $250,000 after the date of this Agreement;

(ix) each Homology Contract relating to any mortgages, indentures, loans, notes or credit agreements, security agreements or other agreements or instruments relating to the borrowing of money or extension of credit in excess of $500,000 or creating any material Encumbrances with respect to any assets of Homology or any loans or debt obligations with officers or directors of Homology;

(x) each Homology Contract requiring payment by or to Homology after the date of this Agreement in excess of $500,000 pursuant to its express terms relating to: (A) any distribution agreement (identifying any that contain exclusivity provisions), (B) any agreement involving provision of services or products with respect to any pre-clinical or clinical development activities of Homology, (C) any dealer, distributor, joint marketing, alliance, joint venture, cooperation, development or other agreement currently in force under which Homology or any of its Subsidiaries has continuing obligations to develop or market any product, technology or service, or any agreement pursuant to which Homology or any of its Subsidiaries has continuing obligations to develop any Intellectual Property that will not be owned, in whole or in part, by Homology or such Subsidiary or (D) any Contract to license any Patent, trademark registration, service mark registration, trade name or copyright registration to or from any third party to manufacture or produce any product, service or technology of Homology or any of its Subsidiaries or any Contract to sell, distribute or commercialize any products or service of Homology or any of its Subsidiaries, in each case, except for Homology Contracts entered into in the Ordinary Course of Business;

(xi) each Homology Contract with any Person, including any financial advisor, broker, finder, investment banker or other Person, providing advisory services to Homology in connection with the Contemplated Transactions;

(xii) each Homology Contract to which Homology or any of its Subsidiaries is a party or by which any of their assets and properties is currently bound, which involves annual obligations of payment by, or annual payments to, Homology or such Subsidiary in excess of $500,000;

(xiii) a Homology Real Estate Lease;

(xiv) a Contract disclosed in or required to be disclosed in Section 4.12(b) or Section 4.12(c) of the Homology Disclosure Schedule; or

(xv) any other Homology Contract that is not terminable at will (with no penalty or payment) by Homology or any of its Subsidiaries, and (A) which involves payment or receipt by Homology or such Subsidiary after the date of this Agreement under any such agreement, contract or commitment of more than $500,000 in the aggregate, or obligations after the date of this Agreement in excess of $1,000,000 in the aggregate or (B) that is material to the business or operations of Homology and its Subsidiaries taken as a whole.

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written form. Homology has not, nor, to Homology’s Knowledge as of the date of this Agreement, has any other party to a Homology Material Contract, breached, violated or defaulted under, or received notice that it breached, violated or defaulted under, any of the terms or conditions of any Homology Material Contract in such manner as would permit any other party to cancel or terminate any such Homology Material Contract, or would permit any other party to seek damages which would reasonably be expected to have a Homology Material Adverse Effect. As to Homology and its Subsidiaries, as of the date of this Agreement, each Homology Material Contract is valid, binding, enforceable and in full force and effect, subject to the Enforceability Exceptions. No Person is renegotiating, or has a right pursuant to the terms of any Homology Material Contract to change, any material amount paid or payable to Homology under any Homology Material Contract or any other material term or provision of any Homology Material Contract.

4.14 Compliance; Permits; Restrictions.

(a) Homology and each of its Subsidiaries is, and since January 1, 2020, has been in material compliance with all applicable Laws. No investigation, claim, suit, proceeding, audit, Order, or other action by any Governmental Authority is pending or, to the Knowledge of Homology, threatened against Homology or any of its Subsidiaries. There is no agreement or Order binding upon Homology or any of its Subsidiaries which (i) has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Homology or any of its Subsidiaries, any acquisition of material property by Homology or any of its Subsidiaries or the conduct of business by Homology or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Homology’s ability to comply with or perform any covenant or obligation under this Agreement or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.

(b) Each of Homology and its Subsidiaries holds all required Governmental Authorizations that are material to the operation of the business of Homology and Merger Sub as currently conducted (collectively, the “Homology Permits”). Section 4.14(b) of the Homology Disclosure Schedule identifies each Homology Permit. Each of Homology and its Subsidiaries is in material compliance with the terms of the Homology Permits. No Legal Proceeding is pending or, to the Knowledge of Homology, threatened, which seeks to revoke, substantially limit, suspend, or materially modify any Homology Permit.

(c) There are no Legal Proceedings pending or, to the Knowledge of Homology, threatened in writing with respect to an alleged material violation by Homology or any of its Subsidiaries of the FDCA, PHSA, FDA regulations adopted thereunder, the Controlled Substances Act or any other Law promulgated by a Drug Regulatory Agency.

(d) Each of Homology and its Subsidiaries holds all required material Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Homology and Merger Sub as currently conducted, and, as applicable, the research, development, testing, manufacturing, packaging, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its product candidates (the “Homology Product Candidates”) (collectively, the “Homology Regulatory Permits”) and no such Homology Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any material, adverse manner. Homology has timely maintained and is in compliance in all material respects with the Homology Regulatory Permits and neither Homology nor any of its Subsidiaries has, since January 1, 2020, received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Homology Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Homology Regulatory Permit.

(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Homology or its Subsidiaries, in which Homology or its Subsidiaries or their respective product candidates, including the Homology Product Candidates, have participated, were and, if still pending, are being conducted in

 

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compliance in all material respects with the applicable regulations of the Drug Regulatory Agencies and other applicable Law, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Other than as set forth on Section 4.14(e) of the Homology Disclosure Schedule, neither Homology nor any of its Subsidiaries has received any written notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to the Knowledge of Homology, any action to place a clinical hold order on, or otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, Homology or any of its Subsidiaries or in which Homology or any of its Subsidiaries or its current product candidates, including the Homology Product Candidates, have participated.

(f) Neither Homology nor any of its Subsidiaries has, and, to the Knowledge of Homology, any contract manufacturer with respect to any Homology Product Candidate, is the subject of any pending or, to the Knowledge of Homology, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto, or any other applicable Law. To the Knowledge of Homology, neither Homology nor any of its Subsidiaries nor any contract manufacturer with respect to any Homology Product Candidate has committed any acts, made any statement, or failed to make any statement, in each case in respect of Homology’s business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto, or any other applicable Law. None of Homology, any of its Subsidiaries, and to the Knowledge of Homology, any contract manufacturer with respect to any Homology Product Candidate, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion under (i) 21 U.S.C. Section 335a (ii) 42 U.S.C. § 1320a-7, or (iii) any other applicable Law. To the Knowledge of Homology, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Homology, any of its Subsidiaries, and to the Knowledge of the Homology, any contract manufacturer with respect to any Homology Product Candidate, or any of its officers, employees or agents. Neither Homology nor any of its Subsidiaries is a party to or has any reporting obligations under any corporate integrity agreements, monitoring agreements, deferred or non-prosecution agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Authority.

(g) All manufacturing operations conducted by, or to the Knowledge of Homology, for the benefit of, Homology or its Subsidiaries in connection with any Homology Product Candidate, since January 1, 2020, have been and are being conducted in compliance in all material respects with applicable Laws, including the FDA’s standards for current good manufacturing practices, including applicable requirements contained in 21 C.F.R. Parts 210, 211, 600-680 and 1271, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States.

(h) No laboratory or manufacturing site owned by Homology or its Subsidiaries, and to the Knowledge of Homology, no manufacturing site of a contract manufacturer or laboratory, with respect to any Homology Product Candidate, (i) is subject to a Drug Regulatory Agency shutdown or import or export prohibition or (ii) has since January 1, 2020, received any unresolved Form FDA 483, notice of violation, warning letter, untitled letter, or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting material noncompliance with any applicable Law, and, to the Knowledge of Homology, neither the FDA nor any other Governmental Authority is considering such action.

4.15 Legal Proceedings; Orders.

(a) Except as set forth in Section 4.15 of the Homology Disclosure Schedule, there is no pending Legal Proceeding and, to the Knowledge of Homology, no Person has threatened in writing to commence any Legal Proceeding: (i) that involves Homology or any of its Subsidiaries or any Homology Associate (in his or her capacity as such) or any of the material assets owned or used by Homology or any of its Subsidiaries or (ii) that challenges, or that may have the effect of preventing, delaying, making illegal or otherwise interfering with, the Contemplated Transactions.

 

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(b) There is no Order to which Homology or any of its Subsidiaries, or any of the material assets owned or used by Homology or any of its Subsidiaries is subject. To the Knowledge of Homology, no officer or other Key Employee of Homology or any of its Subsidiaries is subject to any Order that prohibits such officer or employee from engaging in or continuing any conduct, activity or practice relating to the business of Homology or any of its Subsidiaries or to any material assets owned or used by Homology or any of its Subsidiaries.

4.16 Tax Matters.

(a) Each of Homology and each of its Subsidiaries has timely filed all income Tax Returns and all other material Tax Returns that were required to be filed by or with respect to it under applicable Law. All such Tax Returns were correct and complete in all material respects and have been prepared in material compliance with all applicable Law. Subject to exceptions as would not be material, no claim has ever been made by a Governmental Authority in a jurisdiction where Homology or any of its Subsidiaries does not file a particular type of Tax Return that Homology or any of its Subsidiaries is subject to taxation by that jurisdiction that would require the filing of such a Tax Return.

(b) All material amounts of Taxes due and owing by Homology and each of its Subsidiaries (whether or not shown on any Tax Return) have been timely paid. The unpaid Taxes of Homology and each of its Subsidiaries for periods (or portions thereof) ending on or prior to the date of the Homology Balance Sheet do not materially exceed the accruals for current Taxes set forth on the Homology Balance Sheet. Since the date of the Homology Balance Sheet, neither Homology nor any of its Subsidiaries has incurred any material Liability for Taxes outside the Ordinary Course of Business or otherwise inconsistent with past custom and practice.

(c) Each of Homology and each of its Subsidiaries has withheld and paid to the appropriate Governmental Authority all material Taxes required to have been withheld and paid in connection with any amounts paid or owing to any employee, independent contractor, creditor, stockholder, or other third party.

(d) There are no Encumbrances for material Taxes (other Encumbrances described in clause (i) of the definition of “Permitted Encumbrances”) upon any of the assets of Homology or any of its Subsidiaries.

(e) No deficiencies for a material amount of Taxes with respect to Homology or any of its Subsidiaries have been claimed, proposed or assessed by any Governmental Authority in writing that have not been timely paid in full. There are no pending (or, based on written notice, threatened) material audits, assessments, examinations or other actions for or relating to any Liability in respect of Taxes of Homology or any of its Subsidiaries. Neither Homology nor any of its Subsidiaries has waived any statute of limitations in respect of material Taxes or agreed to any extension of time with respect to a material Tax assessment or deficiency.

(f) Neither Homology nor any of its Subsidiaries is a party to any Tax allocation, Tax sharing or similar agreement (including indemnity arrangements), other than Ordinary Course Agreements.

(g) Neither Homology nor any of its Subsidiaries has been a member of an affiliated group filing a consolidated U.S. federal income Tax Return (other than a group the common parent of which is Homology). Neither Homology nor any of its Subsidiaries has any material Liability for the Taxes of any Person (other than Homology and Merger Sub) under Treasury Regulations Section 1.1502-6 (or any similar provision of state, local, or foreign law), as a transferee or successor, or by Contract (other than an Ordinary Course Agreement).

(h) Neither Homology nor any of its Subsidiaries has distributed stock of another Person, or has had its stock distributed by another Person, in a transaction that was purported or intended to be governed in whole or in part by Section 355 of the Code or Section 361 of the Code.

(i) Neither Homology nor any of its Subsidiaries has entered into any transaction identified as a “reportable transaction” for purposes of Treasury Regulations Section 1.6011-4(b)(2).

 

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(j) Neither Homology nor any of its Subsidiaries will be required to include any material item of income or gain in, or exclude any material item of deduction or loss from, taxable income for any taxable period (or portion thereof) ending after the Closing Date as a result of any: (i) change in, or use of improper, method of accounting for a taxable period ending on or prior to the Closing Date; (ii) “closing agreement” as described in Section 7121 of the Code (or any corresponding or similar provision of state, local or foreign income Tax law) executed on or prior to the Closing Date; (iii) installment sale or open transaction disposition made on or prior to the Closing Date; (iv) prepaid amount, advance payments or deferred revenue received or accrued on or prior to the Closing Date; or (v) intercompany transaction or excess loss amount described in Treasury Regulations under Section 1502 of the Code (or any corresponding or similar provision of state, local or foreign income Tax Law).

(k) Section 4.16(k) of the Homology Disclosure Schedule sets forth the entity classification of Homology and each of its Subsidiaries for U.S. federal income tax purposes. Neither Homology nor any of its Subsidiaries has made an election or taken any other action to change its federal and state income tax classification from such classification.

(l) Neither Homology nor any of its Subsidiaries has taken or knowingly failed to take any action, nor to the Knowledge of Homology, are there any facts or circumstances, in each case, that would reasonably be expected to prevent or impede the Merger from qualifying for the Intended Tax Treatment.

4.17 Employee and Labor Matters; Benefit Plans.

(a) Section 4.17(a) of the Homology Disclosure Schedule contains a complete and accurate list of all Homology employees as of the date of this Agreement, setting forth for each employee: job title; classification as exempt or non-exempt for wage and hour purposes; annual base salary, hourly rate or other rates of compensation; bonus potential; full-time or part-time status; date of hire; business location; status (i.e., active or inactive and if inactive, the type of leave and estimated duration); and any visa or work permit status and the date of expiration, if applicable.

(b) Section 4.17(b) of the Homology Disclosure Schedule contains a complete and accurate list as of the date hereof of all of the independent contractors, consultants, temporary employees, leased employees or other agents employed or used by Homology and classified by Homology as other than employees, or compensated other than through wages paid by Homology through Homology’s payroll department (“Homology Contingent Workers”), showing for each Homology Contingent Worker such individual’s engagement date, role in the business, work location, and fee or compensation arrangements.

(c) Neither Homology nor any of its Subsidiaries is a party to, bound by the terms of, or has a duty to bargain under, any collective bargaining agreement or other Contract with a labor union, works council or labor organization representing any Homology Associate, and there are no labor unions, works council or labor organizations representing or, to the Knowledge of Homology, purporting to represent or seeking to represent any Homology Associates, including through the filing of a petition for representation election.

(d) Section 4.17(d) of the Homology Disclosure Schedule lists all material Homology Employee Plans.

(e) As applicable with respect to each material Homology Employee Plan, Homology has made available to Q32, true and complete copies of (i) the plan document, including all amendments thereto, and in the case of an unwritten Employee Plan, a written description of all material terms thereof, (ii) all related trust instruments or other funding-related documents and insurance contracts, (iii) the summary plan description and each summary of material modifications thereto, (iv) the financial statements for the most recent year for which such financial statements are available (in audited form, if available or required by ERISA) and, where applicable, annual reports with any Governmental Authority (e.g., Form 5500 and all schedules thereto), (v) the most recent IRS determination or opinion letter, (vi) written results of any required compliance testing for the three most recent plan years, and (vii) all material, non-routine notices, filings or correspondence during the past three years with any Governmental Authority.

 

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(f) Each Homology Employee Plan that is intended to be qualified under Section 401(a) of the Code has received a favorable determination letter or may rely on a favorable opinion letter with respect to such qualified status from the IRS to the effect that such plan is qualified under Section 401(a) of the Code and the related trust is exempt from federal income Taxes under Section 501(a) of the Code. To the Knowledge of Homology, nothing has occurred that would reasonably be expected to cause the loss of the qualified status of any such Homology Employee Plan or the Tax exempt status of any related trust.

(g) Each Homology Employee Plan has been established, maintained and operated in compliance, in all material respects, with its terms and all applicable Laws, including, without limitation, the Code and ERISA. No Legal Proceeding (other than those relating to routine claims for benefits) is pending or, to the Knowledge of Homology, threatened with respect to any Homology Employee Plan. All material payments and/or contributions required to have been made with respect to all Homology Employee Plans have been made in accordance with the terms of the applicable Homology Employee Plan and applicable Law in all material respects and neither the Homology nor any Homology ERISA Affiliate has any material Liability for any such unpaid contributions with respect to any Homology Employee Plan.

(h) Neither Homology, any of its Subsidiaries nor any of their ERISA Affiliates maintains, contributes to or is required to contribute to, or has any Liability with respect to (i) any “employee benefit plan” (within the meaning of Section 3(2) of ERISA) that is or was subject to Title IV or Section 302 of ERISA or Section 412 of the Code, (ii) a Multiemployer Plan, (iii) any Multiple Employer Plan, or (iv) any Multiple Employer Welfare Arrangement.

(i) No Homology Employee Plan provides for medical or other welfare benefits to any service provider beyond termination of service or retirement, other than (i) pursuant to COBRA or an analogous state law requirement (the full cost of which is borne by such Person or such Person’s dependents or beneficiaries) or (ii) continuation coverage through the end of the month in which such termination or retirement occurs.

(j) No Homology Employee Plan is subject to any law of a foreign jurisdiction outside of the United States.

(k) Each Homology Employee Plan that constitutes in any part a nonqualified deferred compensation plan within the meaning of Section 409A of the Code has complied in all material respects with Section 409A of the Code, to the extent applicable, and no compensation has been or would reasonably be expected to be includable in the gross income of any Homology Associate as a result of the operation of Section 409A of the Code.

(l) Homology and its Subsidiaries are, and since January 1, 2020 have been, in compliance in all material respects with all applicable Laws respecting labor, employment and employment practices, including terms and conditions of employment, worker classification, tax withholding, unemployment compensation, workers’ compensation, prohibited discrimination, harassment, equal employment, fair employment practices, meal and rest periods, work authorization and immigration status, employee safety and health, wages (including overtime wages), pay equity, affirmative action, restrictive covenants, compensation, and hours of work. There are no Legal Proceedings pending or, to the Knowledge of Homology, threatened against Homology or any of its Subsidiaries relating to any labor or employment matters or any Homology Associate. Homology is not a party to a conciliation agreement, consent decree or other agreement or Order with any federal, state, or local agency or Governmental Authority with respect to employment practices.

(m) Since January 1, 2020, (i) Homology has not taken any action which would constitute a “plant closing”, “collective dismissal”, “group dismissal”, “group termination”, “mass termination”, or “mass layoff” within the meaning of the WARN Act, (ii) issued any written notification of a plant closing or mass layoff required by the WARN Act (nor has Homology or any of its Subsidiaries been under any requirement or obligation to issue any such notification), or (iii) incurred any Liability or obligation under the WARN Act that remains unsatisfied.

(n) Since January 1, 2020, there has never been, nor to the Knowledge of Homology has there been any threat of, any strike, slowdown, work stoppage, lockout, job action, union, organizing activity, question

 

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concerning representation or any similar activity or dispute, affecting Homology or its Subsidiaries. No event has occurred within the past six (6) months, and, to the Knowledge of Homology, no condition or circumstance exists, that would reasonably be expected to give rise to or provide a basis for the commencement of any such strike, slowdown, work stoppage, lockout, job action, union organizing activity, question concerning representation or any similar activity or dispute.

(o) There is no contract, agreement, plan or arrangement to which Homology or any of its Subsidiaries is a party or by which it is bound to make any payment or compensate any Homology Associate for Taxes incurred pursuant to the Code, including, but not limited to, Section 4999 or Section 409A of the Code.

(p) Neither the execution and delivery of this Agreement, the shareholder approval of this Agreement, nor the consummation of the Contemplated Transactions (either alone or in conjunction with any other event, including without limitation, a termination of employment) will result in any (i) payment (including severance, forgiveness of indebtedness or otherwise) or benefit becoming due to Homology Associate, (ii) increase in any benefits or the compensation payable under any Homology Employee Plan, (iii) acceleration of the time of payment, funding or vesting of any such compensation or benefits or any loan forgiveness, (iv) restriction on the right of Homology or any of its Subsidiaries or, after the consummation of Contemplated Transactions, the Surviving Corporation, to merge, amend, terminate or transfer any Homology Employee Plan, or (v) “excess parachute payment” (within the meaning of Section 280G of the Code).

4.18 Environmental Matters. Since January 1, 2020, Homology and each of its Subsidiaries has complied with all applicable Environmental Laws, which compliance includes the possession by Homology of all permits and other Governmental Authorizations required under applicable Environmental Laws and compliance with the terms and conditions thereof, except for any failure to be in compliance that, individually or in the aggregate, would not result in a Homology Material Adverse Effect. Neither Homology nor any of its Subsidiaries has received since January 1, 2020, any written notice or other communication (in writing or otherwise), whether from a Governmental Authority, citizens group, employee or otherwise, that alleges that Homology or any of its Subsidiaries is not in compliance with any Environmental Law, and, to the Knowledge of Homology, there are no circumstances that may prevent or interfere with Homology’s or any of its Subsidiaries’ compliance with any Environmental Law in the future, except where such failure to comply would not reasonably be expected to have a Homology Material Adverse Effect. To the Knowledge of Homology: (a) no current or prior owner of any property leased or controlled by Homology or any of its Subsidiaries has received since January 1, 2020, any written notice or other communication relating to property owned or leased at any time by Homology or any of its Subsidiaries, whether from a Governmental Authority, citizens group, employee or otherwise, that alleges that such current or prior owner or Homology or any of its Subsidiaries is not in compliance with or violated any Environmental Law relating to such property and (b) neither Homology nor any of its Subsidiaries has any material Liability under any Environmental Law.

4.19 Insurance. Homology has made available to Q32 accurate and complete copies of all material insurance policies and all material self-insurance programs and arrangements relating to the business, assets, liabilities and operations of Homology and its Subsidiaries (including Merger Sub). Each of such insurance policies is in full force and effect and Homology and its Subsidiaries (including Merger Sub) are in compliance in all material respects with the terms thereof. Other than customary end of policy notifications from insurance carriers, since January 1, 2020, neither Homology nor any of its Subsidiaries has received any notice or other communication regarding any actual or possible: (a) cancellation or invalidation of any insurance policy or (b) refusal or denial of any coverage, reservation of rights or rejection of any material claim under any insurance policy. Each of Homology and its Subsidiaries (including Merger Sub) has provided timely written notice to the appropriate insurance carrier(s) of each Legal Proceeding pending against Homology or such Subsidiary for which Homology or such Subsidiary has insurance coverage, and no such carrier has issued a denial of coverage or a reservation of rights with respect to any such Legal Proceeding, or informed Homology or any of its Subsidiaries of its intent to do so.

 

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4.20 Transactions with Affiliates. Except as set forth in the Homology SEC Documents filed prior to the date of this Agreement, since the date of Homology’s last proxy statement filed in 2022 with the SEC, no event has occurred that would be required to be reported by Homology pursuant to Item 404 of Regulation S-K promulgated by the SEC. Section 4.20 of the Homology Disclosure Schedule identifies each Person who is (or who may be deemed to be) an Affiliate of Homology as of the date of this Agreement.

4.21 No Financial Advisors. Except as set forth on Section 4.21 of the Homology Disclosure Schedule, no broker, finder or investment banker is entitled to any brokerage fee, finder’s fee, opinion fee, success fee, transaction fee or other fee or commission in connection with the Contemplated Transactions based upon arrangements made by or on behalf of Homology.

4.22 Valid Issuance; No Bad Actor. The Homology Common Stock to be issued in the Merger will, when issued in accordance with the provisions of this Agreement, be validly issued, fully paid and nonassessable. To the Knowledge of Homology, as of the date of this Agreement and as of the Closing, no “bad actor” disqualifying event described in Rule 506(d)(l)(i)-(viii) of the Securities Act (a “Disqualifying Event”) is applicable to Homology or, to Homology’s Knowledge, any Homology Covered Person, except for a Disqualifying Event as to which Rule 506(d)(2)(ii-iv) or (d)(3) of the Securities Act is applicable.

4.23 Privacy and Data Security.

(a) Homology and its Subsidiaries have complied with all applicable Privacy Laws and the applicable terms of any Homology Contracts relating to privacy, security, collection or use of Personal Information of any individuals (including clinical trial participants, patients, patient family members, caregivers or advocates, physicians and other health care professionals, clinical trial investigators, researchers, pharmacists) that interact with Homology or any of its Subsidiaries in connection with the operation of Homology’s and its Subsidiaries’ business, except for such noncompliance as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Homology Material Adverse Effect. To the Knowledge of Homology, Homology has implemented and maintains reasonable written policies and procedures, satisfying the requirements of applicable Privacy Laws and Homology Contracts, concerning the privacy, security, collection and use of Personal Information (“Homology Privacy Policies”) and has complied with the same, except for such noncompliance as has not to the Knowledge of Q32 had, and would not reasonably be expected to have, individually or in the aggregate, a Q32 Material Adverse Effect. To the Knowledge of Homology, as of the date hereof, no claims have been asserted or threatened against Homology by any Person alleging a violation of Privacy Laws, Privacy Policies and/or the applicable terms of any Homology Contracts relating to privacy, security, collection or use of Personal Information of any individuals and Homology has not received written notice of any of the same. To the Knowledge of Homology, there have been no data security incidents, personal data breaches or other adverse events or incidents related to Personal Information or Homology data in the custody or control of Homology or any service provider acting on behalf of Homology, in each case where such incident, breach or event would result in a notification obligation to any Person under applicable law or pursuant to the terms of any Homology Contract.

(b) The information technology assets and equipment of Homology and its Subsidiaries (collectively, “Homology IT Systems”) are adequate for, and operate and perform in all material respects as required in connection with the operation of the business of Homology and its Subsidiaries as currently conducted, and to the Knowledge of Homology, free and clear of all material bugs, errors, defects, Trojan horses, time bombs, malware and other corruptants. Homology and its Subsidiaries have implemented and maintain commercially reasonable physical, technical and administrative safeguards to protect Personal Information processed by or on behalf of Homology and its Subsidiaries, any other material confidential information and the integrity and security of Homology IT Systems used in connection with their businesses, and during the past three years, there have been no breaches, violations, outages or unauthorized uses of or accesses to same, except for those that have been remedied without material cost or liability or the duty to notify any other Person.

 

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4.24 No Other Representations or Warranties. Homology hereby acknowledges and agrees that, except for the representations and warranties contained in this Agreement, neither Homology nor any of its Subsidiaries nor any other person on behalf of Homology or its Subsidiaries makes any express or implied representation or warranty with respect to Homology or its Subsidiaries or with respect to any other information provided to Q32, its stockholders or any of its Affiliates in connection with the Contemplated Transactions, and (subject to the express representations and warranties of Homology set forth in Article IV (in each case as qualified and limited by the Homology Disclosure Schedule)) none of Q32, its Representatives, stockholders or members, has relied on any such information (including the accuracy or completeness thereof).

ARTICLE V

COVENANTS

5.1 Conduct of Q32’s Business. From the date hereof until the earlier of the Effective Time and the termination of this Agreement in accordance with Article VIII (the “Pre-Closing Period”), except as set forth on Section 5.1 of the Q32 Disclosure Schedule, as required by applicable Law, as otherwise provided by this Agreement and the Contemplated Transactions or with Homology’s prior written consent (not to be unreasonably withheld, conditioned or delayed), Q32 shall, and shall cause its Subsidiaries to, use their commercially reasonable efforts to conduct its operations in the Ordinary Course of Business and to preserve intact the present business organizations and goodwill of the business and the present relationships of the business with material customers and suppliers. Without limiting the generality of the foregoing, during the Pre-Closing Period, except as set forth in Section 5.1 of the Q32 Disclosure Schedule, as required by applicable Law, as otherwise specifically provided by this Agreement and the Contemplated Transactions or with Homology’s prior written consent (not to be unreasonably withheld, conditioned or delayed), Q32 shall not, and shall cause its Subsidiaries not to:

(a) sell, lease, license or otherwise dispose of any material assets of Q32, or in either case, any interests therein, except (i) pursuant to existing Contracts, (ii) for sales or licensing of products to customers or (iii) otherwise in the Ordinary Course of Business;

(b) take any action with respect to any equity interests of Q32 or any of its Subsidiaries, including any issuance, sale, transfer, redemption, repurchase, recapitalization, adjustment, split, combination, reclassification, dividend, distribution or any other action in respect thereof;

(c) create, incur, assume, guarantee or repay (other than any mandatory repayments) any indebtedness, other than in the Ordinary Course of Business or as approved by the Q32 Board;

(d) issue, deliver, sell, grant, pledge, transfer, subject to any Encumbrance or dispose of any Q32 Capital Stock or the securities of any Subsidiary of Q32;

(e) create or otherwise incur any Encumbrance on any material asset of Q32 or any of its Subsidiaries, other than Permitted Encumbrances;

(f) make any loans, advances or capital contributions to, or investments in, any Person other than Q32;

(g) adversely amend or otherwise adversely modify in any material respect or terminate (excluding any expiration in accordance with its terms) any Contract listed in Section 3.12 of the Q32 Disclosure Schedule, other than any amendment or modification entered into in the Ordinary Course of Business and containing terms not materially less favorable to Q32 than the terms of such Contract in effect as of the date of this Agreement;

(h) enter into any Contract that would be required to be disclosed in Section 3.12 of the Q32 Disclosure Schedule if such Contract were in effect as of the date of this Agreement, other than any such Contract entered into in the Ordinary Course of Business;

 

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(i) except as required by any Q32 Employee Plan or as required by applicable Law, (i) increase any salary, wage or other compensation or benefit to, or enter into or amend any employment, retention, change-in-control, termination or severance agreement with, any Q32 Associate, other than annual increases in base compensation in the Ordinary Course of Business with respect to employees whose annual base compensation is less than $500,000 and provided that such increases do not, individually or in the aggregate, result in any material increase in costs, obligations or liabilities for Q32 and its Subsidiaries, (ii) grant or pay any bonuses to any Q32 Associate, other than in the Ordinary Course of Business, or (iii) establish, enter into or adopt any new material Q32 Employee Plan or any plan, program, policy, agreement or arrangement that would be a material Q32 Employee Plan if it was in effect on the date hereof or amend or modify, in a manner that would, individually or in the aggregate, materially increase costs, obligations or liabilities for Q32 and its Subsidiaries or the Surviving Corporation, any existing Q32 Employee Plan or accelerate the vesting of any compensation (including stock options, restricted stock, restricted stock units, phantom units, warrants, other shares of capital stock or rights of any kind to acquire any shares of capital stock or equity-based awards) for the benefit of any Q32 Associate other than in the Ordinary Course of Business;

(j) adopt, enter into, amend or terminate any collective bargaining agreement or Contract with any labor union, works council or labor organization;

(k) settle any material Legal Proceeding involving Q32 or any of its Subsidiaries or relating to the transactions contemplated by this Agreement;

(l) make or change any material Tax election, change any annual Tax accounting period, enter into any closing agreement with a Governmental Authority with respect to material Taxes or settle any Tax claim with respect to material Taxes, in each case, except if such action would not reasonably be expected to have a material and adverse effect on Q32 following the Closing;

(m) take any action, or knowingly fail to take any action, where such action or failure to act would reasonably be expected to prevent the Merger from qualifying for the Intended Tax Treatment;

(n) make any material change in any method of financial accounting or financial accounting practice of Q32 or any of its Subsidiaries, except for any such change required by reason of a change in GAAP or other applicable financial accounting standards;

(o) other than in connection with actions contemplated by this Agreement, adopt, approve, consent to or propose any change in the Organizational Documents of Q32 or any of its Subsidiaries; or

(p) agree or commit to do any of the foregoing.

Notwithstanding the generality of the foregoing, nothing set forth in this Section 5.1 shall restrict Q32’s rights to effectuate the Concurrent Financing upon the terms set forth in the Subscription Agreement on the date hereof. Nothing contained in this Agreement shall give Homology, directly or indirectly, the right to control or direct the operations of Q32 prior to the Effective Time. Prior to the Effective Time, Q32 shall exercise, consistent with the terms and conditions of this Agreement, complete unilateral control and supervision over its business operations.

5.2 Conduct of Homology’s Business. During the Pre-Closing Period, except as set forth on Section 5.2 of the Homology Disclosure Schedule, as required by applicable Law, as otherwise provided by this Agreement and the Contemplated Transactions or with Q32’s prior written consent (not to be unreasonably withheld, conditioned or delayed), Homology shall, and shall cause its Subsidiaries to, use their commercially reasonable efforts to conduct its operations in the Ordinary Course of Business and to preserve intact the present business organizations and goodwill of the business and the present relationships of the business with material customers and suppliers. Without limiting the generality of the foregoing, during the Pre-Closing Period, except as set forth

 

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in Section 5.2 of the Homology Disclosure Schedule, as required by applicable Law, as otherwise specifically provided by this Agreement and the Contemplated Transactions or with Q32’s prior written consent (not to be unreasonably withheld, conditioned or delayed), Homology shall not, and shall cause its Subsidiaries not to:

(a) sell, lease, license or otherwise dispose of any material assets of Homology, or in either case, any interests therein, except (i) pursuant to existing Contracts, (ii) for sales or licensing of products to customers or (iii) otherwise in the Ordinary Course of Business;

(b) except for the issuance of securities under this Agreement, take any action with respect to any equity interests of Homology or any of its Subsidiaries, including any issuance, sale, transfer, redemption, repurchase, recapitalization, adjustment, split, combination, reclassification, dividend, distribution or any other action in respect thereof;

(c) create, incur, assume, guarantee or repay (other than any mandatory repayments) any indebtedness;

(d) issue, deliver, sell, grant, pledge, transfer, subject to any Encumbrance or dispose of any Homology Common Stock or the securities of any Subsidiary of Homology;

(e) create or otherwise incur any Encumbrance on any material asset of Homology, other than Permitted Encumbrances;

(f) make any loans, advances or capital contributions to, or investments in, any Person other than Homology;

(g) adversely amend or otherwise adversely modify in any material respect or terminate (excluding any expiration in accordance with its terms) any Contract listed in Section 4.13 of the Homology Disclosure Schedule, other than any amendment or modification entered into in the Ordinary Course of Business and containing terms, not materially less favorable to Homology than the terms of such Contract in effect as of the date of this Agreement;

(h) enter into any Contract that would be required to be disclosed in Section 4.13 of the Homology Disclosure Schedule if such Contract were in effect as of the date of this Agreement, other than any such Contract entered into in the Ordinary Course of Business;

(i) except as required by any Homology Employee Plan, applicable Law or this Agreement, (i) increase any salary, wage or other compensation or benefit to, or enter into or amend any employment, retention, change-in-control, termination or severance agreement with, any Homology Associate, other than as set forth in Section 5.2(i)of the Homology Disclosure Schedule and provided that such increases do not, individually or in the aggregate, result in any material increase in costs, obligations or liabilities for Homology and its Subsidiaries, (ii) grant or pay any bonuses to any Homology Associate, (iii) establish, enter into or adopt any new Homology Employee Plan or any plan, program, policy, agreement or arrangement that would be a material Homology Employee Plan if it was in effect on the date hereof or amend or modify, in a manner that would, individually or in the aggregate, materially increase costs, obligations or liabilities for Homology and its Subsidiaries or the Surviving Corporation, any existing Homology Employee Plan or accelerate the vesting of any compensation (including stock options, restricted stock, restricted stock units, phantom units, warrants, other shares of capital stock or rights of any kind to acquire any shares of capital stock or equity-based awards) for the benefit of any Homology Associate, (iv) grant to any Homology Associate any right to receive, or pay to any Homology Associate, any severance, change in control, transaction, retention, termination or similar compensation or benefits or increases therein, (v) take any action to accelerate any payment or benefit, or the funding of any payment or benefit, payable or to be provided to any Homology Associate, (vi) grant any new long-term incentive or equity-based awards, or amend or modify the terms of any such outstanding awards under any Homology Employee Plan or (vii) hire, terminate (other than for cause), promote or change the employment status or title of any Homology Associate;

 

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(j) adopt, enter into, amend or terminate any collective bargaining agreement or Contract with any labor union, works council or labor organization;

(k) settle any material Legal Proceeding involving Homology or relating to the transactions contemplated by this Agreement;

(l) make or change any material Tax election, change any annual Tax accounting period, enter into any closing agreement with a Governmental Authority with respect to material Taxes or settle any Tax claim with respect to material Taxes, in each case, except if such action would not reasonably be expected to have a material and adverse effect on Homology following the Closing;

(m) take any action, or knowingly fail to take any action, where such action or failure to act would reasonably be expected to prevent the Merger from qualifying for the Intended Tax Treatment;

(n) make any material change in any method of financial accounting or financial accounting practice of Homology, except for any such change required by reason of a change in GAAP or other applicable financial accounting standards;

(o) other than in connection with actions contemplated by this Agreement, adopt, approve, consent to or propose any change in the Organizational Documents of Homology; or

(p) agree or commit to do any of the foregoing.

Notwithstanding the generality of the foregoing, nothing set forth in this Section 5.2 shall restrict Homology’s right to (i) effectuate any Legacy Asset Disposition or (ii) encumber, abandon or not file, prosecute, maintain, defend, or enforce any Homology Legacy IP Rights (“Abandoned Homology Legacy IP Rights”). Nothing contained in this Agreement shall give Q32, directly or indirectly, the right to control or direct the operations of Homology prior to the Effective Time. Prior to the Effective Time, Homology shall exercise, consistent with the terms and conditions of this Agreement, complete unilateral control and supervision over its business operations.

5.3 Access and Investigation.

(a) Subject to the terms of the Confidentiality Agreement, which the Parties agree will continue in full force following the date of this Agreement, during the Pre-Closing Period, upon reasonable notice, Homology, on the one hand, and Q32, on the other hand, shall and shall use commercially reasonable efforts to cause such Party’s Representatives to: (i) provide the other Party and such other Party’s Representatives with reasonable access during normal business hours to such Party’s Representatives, personnel and assets and to all existing books, records, Tax Returns, work papers and other documents and information relating to such Party and its Subsidiaries, (ii) provide the other Party and such other Party’s Representatives with such copies of the existing books, records, Tax Returns, work papers, product data, and other documents and information relating to such Party and its Subsidiaries, and with such additional financial, operating and other data and information regarding such Party and its Subsidiaries as the other Party may reasonably request, (iii) permit the other Party’s officers and other employees to meet, upon reasonable notice and during normal business hours, with the chief financial officer and other officers and managers of such Party responsible for such Party’s financial statements and the internal controls of such Party to discuss such matters as the other Party may deem reasonably necessary or appropriate, and (iv) provide the other Party with copies, when available, of unaudited financial statements or management accounts, and communications sent by or on behalf of such Party to its stockholders or any material notice, report or other document filed with or sent to or received from any Governmental Authority in connection with the Contemplated Transactions. Any investigation conducted by either Homology or Q32 pursuant to this Section 5.3 shall be conducted in such manner as not to interfere unreasonably with the conduct of the business of the other Party.

 

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(b) Notwithstanding anything herein to the contrary in this Section 5.3, no access or examination contemplated by this Section 5.3 shall be permitted to the extent that it would require any Party or its Subsidiaries to waive the attorney-client privilege or attorney work product privilege, or violate any applicable Law; provided, that such Party or its Subsidiary (i) shall be entitled to withhold only such information that may not be provided without causing such violation or waiver, (ii) shall provide to the other Party all related information that may be provided without causing such violation or waiver (including, to the extent permitted, redacted versions of any such information) and (iii) shall enter into such effective and appropriate joint-defense agreements or other protective arrangements as may be reasonably requested by the other Party in order that all such information may be provided to the other Party without causing such violation or waiver.

5.4 No Solicitation.

(a) Each of Homology and Q32 agrees that, during the Pre-Closing Period, neither it nor any of its Subsidiaries shall, nor shall it or any of its Subsidiaries authorize any of its Representatives to, directly or indirectly: (i) solicit, initiate or knowingly encourage, induce or facilitate the communication, making, submission or announcement of any Acquisition Proposal or Acquisition Inquiry or take any action otherwise inconsistent with past practice that could reasonably be expected to lead to an Acquisition Proposal or Acquisition Inquiry, (ii) furnish any non-public information regarding such Party to any Person (other than Q32 or Homology) in connection with or in response to an Acquisition Proposal or Acquisition Inquiry, (iii) engage in discussions or negotiations with any Person with respect to any Acquisition Proposal or Acquisition Inquiry, (iv) approve, endorse or recommend any Acquisition Proposal (subject to Section 5.9), (v) execute or enter into any letter of intent or any Contract contemplating or otherwise relating to any Acquisition Transaction or (vi) publicly propose to do any of the foregoing; provided, however, that, notwithstanding anything contained in this Section 5.3(a) and subject to compliance with this Section 5.3(a), prior to the approval of this Agreement by Homology’s stockholders (i.e., the Required Homology Stockholder Vote), Homology may furnish non-public information regarding Homology and its Subsidiaries to, and enter into discussions or negotiations with, any Person in response to a bona fide written Acquisition Proposal by Homology which the Homology Board determines in good faith, after consultation with Homology’s financial advisors and outside legal counsel, constitutes, or is reasonably likely to result in, a Superior Offer (and is not withdrawn) if: (A) neither Homology nor any Representative of Homology shall have breached this Section 5.3(a) in any material respect, (B) the Homology Board concludes in good faith based on the advice of outside legal counsel, that the failure to take such action would reasonably be expected to be inconsistent with the fiduciary duties of the Homology Board under applicable Law, (C) as promptly as possible after (and in any event within forty-eight hours of) initially furnishing any such non-public information to, or entering into discussions with, such Person, Homology gives Q32 written notice of the identity of such Person to Q32, and of Homology’s intention to furnish non-public information to, or enter into discussions with, such Person, (D) Homology receives from such Person an executed Acceptable Confidentiality Agreement and (E) as promptly as possible after (and in any event within forty-eight hours of) furnishing any such non-public information to such Person, Homology furnishes such non-public information to Q32 (to the extent such information has not been previously furnished by Homology to Q32). Notwithstanding anything to the contrary set forth in this Agreement, Homology and its Representatives may, in any event (without the Homology Board having to make a determination in clause (B) of the preceding sentence), contact any person to (i) seek to clarify and understand the terms and conditions of any Acquisition Proposal made by such Person solely to determine whether such Acquisition Proposal constitutes, or is reasonably likely to result in, a Superior Offer and (ii) inform such Person that has made or, to the knowledge of Homology is considering making an Acquisition Proposal. Without limiting the generality of the foregoing, Homology acknowledges and agrees that, in the event any Representative of Homology takes any action that, if taken by Homology, would constitute a breach of this Section 5.3(a) by Homology, the taking of such action by such Representative shall be deemed to constitute a breach of this Section 5.3(a) by Homology for purposes of this Agreement.

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Business Day after such Party becomes aware of such Acquisition Proposal or Acquisition Inquiry) advise the other Party orally and in writing of such Acquisition Proposal or Acquisition Inquiry (including the identity of the Person making or submitting such Acquisition Proposal or Acquisition Inquiry, and provide a copy of the Acquisition Proposal or Acquisition Inquiry, of if the Acquisition Proposal or Acquisition Inquiry is not written, the terms thereof). Such Party shall keep the other Party reasonably informed with respect to the status and terms of any such Acquisition Proposal or Acquisition Inquiry and any material modification or material proposed modification thereto. In addition to the foregoing, each Party shall provide the other Party with at least forty-eight hours written notice of a meeting of its board of directors (or any committee thereof) at which its board of directors (or any committee thereof) is reasonably expected to consider an Acquisition Proposal or Acquisition Inquiry it has received.

(c) Each Party shall immediately cease and cause to be terminated any existing discussions, negotiations and communications with any Person that relate to any Acquisition Proposal or Acquisition Inquiry as of the date of this Agreement and request the destruction or return of any non-public information provided to such Person.

5.5 Notification of Certain Matters.

(a) During the Pre-Closing Period, each of Q32, on the one hand, and Homology, on the other hand, shall promptly notify the other (and, if in writing, furnish copies of) if any of the following occurs: (i) any notice or other communication is received from any Person alleging that the Consent of such Person is or may be required in connection with any of the Contemplated Transactions, (ii) any Legal Proceeding against or involving or otherwise affecting such Party or its Subsidiaries is commenced, or, to the Knowledge of such Party, threatened against such Party or, to the Knowledge of such Party, any director, officer or Key Employee of such Party, (iii) such Party becomes aware of any inaccuracy in any representation or warranty made by such Party in this Agreement or (iv) the failure of such Party to comply with any covenant or obligation of such Party; in each case that could reasonably be expected to make the timely satisfaction of any of the conditions set forth in Article VI impossible or materially less likely. No such notice shall be deemed to supplement or amend the Q32 Disclosure Schedule or the Homology Disclosure Schedule for the purpose of (A) determining the accuracy of any of the representations and warranties made by Q32 or Homology in this Agreement or (B) determining whether any condition set forth in Article VI has been satisfied. Any failure by either Party to provide notice pursuant to this Section 5.5 shall not be deemed to be a breach for purposes of Section 6.2(b) or 6.3(b), as applicable, unless such failure to provide such notice was knowing and intentional.

(b) During the Pre-Closing Period, Homology shall use reasonable best efforts to consult with Q32 during the negotiation process for, and prior to taking any material action with respect to, any amendment to, sublicense or the potential early termination of the Homology Lease, and shall consider any input received from Q32 in good faith prior to taking any such action.

(c) During the Pre-Closing Period, Homology shall provide to Q32 an updated list of Abandoned Homology Legacy IP Rights on a monthly basis starting from December 1, 2023, with the final such list to be delivered within three (3) days preceding Closing.

5.6 Legacy Asset Disposition.

(a) Prior to the Closing Date, Homology shall be entitled, but under no obligation, to sell, transfer, license, assign or otherwise divest any or all of the assets and rights primarily relating to Homology’s HMI-103 (Adult/Pediatric PKU), HMI-203 (MPS II (Hunter Syndrome)), HMI-204 (MLD), Capsids and AAVHSC Platform (the “Legacy Assets”), including any equity interests held directly or indirectly by Homology in Oxford Biomedica Solutions, LLC or its affiliates (the “Oxford Assets”) in a transaction or series of transactions (the “Legacy Asset Disposition”), provided that Homology as promptly as practicable thereafter notify Q32 of any such Legacy Asset Disposition. Each Party acknowledges that Homology may, in contemplation of the Legacy Asset Disposition, (a) establish one or more Subsidiaries to hold the Legacy Assets, (b) transfer to any such Subsidiary

 

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any or all of the Legacy Assets and the liabilities and obligations related thereto and (c) take such other steps that are reasonably necessary to prepare for the Legacy Asset Disposition. For clarity, if Homology transfers the Legacy Assets to one or more Subsidiaries, the terms of this Section 0 shall apply to such Subsidiaries in addition to Homology. Each Party further acknowledges that Homology may not be successful in completing, or may determine not to proceed, with the Legacy Asset Disposition. Notwithstanding the foregoing, Homology may not enter into any agreement with respect to the Legacy Asset Disposition that would result in a continuing obligation or liability without the prior written consent of Q32 (such consent shall not be unreasonably withheld, conditioned or delayed); provided, further, that Homology shall provide Q32 with a copy of any agreement with respect to an Legacy Asset Disposition that would be reasonably likely to result in a continuing obligation or liability of either Homology or Q32 on or after the Effective Time at least five Business Days prior to entry into such agreement.

(b) For the avoidance of doubt, any sale, transfer, license, assignment or other divestiture of Legacy Assets on or after the Closing Date shall be governed by the terms and conditions of the CVR Agreement.

5.7 Registration Statement; Proxy Statement.

(a) As promptly as practicable (but in any event, no later than twenty (20) Business Days) after the date of this Agreement, (i) Homology, in cooperation with Q32, shall prepare and file with the SEC a proxy statement relating to the Homology Stockholder Meeting to be held in connection with the Merger (together with any amendments thereof or supplements thereto, the “Proxy Statement”) and (ii) Homology, in cooperation with Q32, shall prepare and file with the SEC a registration statement on Form S-4 (the “Form S-4”), in which the Proxy Statement shall be included as a part (the Proxy Statement and the Form S-4, collectively, the “Registration Statement”), in connection with the registration under the Securities Act of the shares of Homology Common Stock to be issued by virtue of the Merger. Each of Homology and Q32 shall use their commercially reasonable efforts to respond promptly to any comments of the SEC or its staff and to cause the Registration Statement to become effective as promptly as practicable, and shall take all or any action required under any applicable federal, state, securities and other Laws in connection with the issuance of shares of Homology Common Stock pursuant to the Merger. Each of the Parties shall furnish all information concerning itself and their Affiliates, as applicable, to the other Parties as the other Parties may reasonably request in connection with such actions and the preparation of the Registration Statement and Proxy Statement.

(b) Homology covenants and agrees that the Registration Statement (and the letter to stockholders, notice of meeting and form of proxy included therewith) will not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary in order to make the statements made therein not misleading. Q32 covenants and agrees that the information supplied by or on behalf of Q32 and its Subsidiaries to Homology for inclusion in the Registration Statement (including the Q32 Financials) will not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary in order to make such information, in light of the circumstances under which they were made, not misleading. Notwithstanding the foregoing, Homology makes no covenant, representation or warranty with respect to statements made in the Registration Statement (and the letter to stockholders, notice of meeting and form of proxy included therewith), if any, based on information provided by Q32 or its Subsidiaries or any of their Representatives for inclusion therein. Q32 and its legal counsel shall be given reasonable opportunity to review and comment on the Registration Statement, including all amendments and supplements thereto, prior to the filing thereof with the SEC, and on the response to any comments on the SEC prior to the filing thereof with the SEC; provided, however, that the foregoing shall not apply to any amendment to the Registration Statement pertaining to a Homology Board Adverse Recommendation Change. Each of the Parties shall use commercially reasonable efforts to cause the Registration Statement to comply with the applicable rules and regulations promulgated by the SEC, to respond promptly to any comments of the SEC or its staff and to have the Registration Statement declared effective under the Securities Act as promptly as practicable after it is filed with the SEC.

 

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(c) Each of the Parties shall use commercially reasonable efforts to cause the Proxy Statement to be mailed to Homology’s stockholders as promptly as practicable after the Registration Statement is declared effective under the Securities Act. If Homology, Merger Sub or Q32 become aware of any event or information that, pursuant to the Securities Act or the Exchange Act, should be disclosed in an amendment or supplement to the Registration Statement or Proxy Statement, as the case may be, then such Party, as the case may be, shall promptly inform the other Parties thereof and shall cooperate with such other Parties in filing such amendment or supplement with the SEC and, if appropriate, in mailing such amendment or supplement to the Homology stockholders.

(d) Q32 shall reasonably cooperate with Homology and provide, and cause its Representatives to provide, Homology and its Representatives, with all true, correct and complete information regarding (i) Q32 and its Subsidiaries and (ii) the 2023 Plans that is, in each case, required by Law to be included in the Registration Statement or reasonably requested by Homology to be included in the Registration Statement. Q32 will use commercially reasonable efforts to cause Q32’s independent accounting firm to deliver any consent that Homology is required to file with the SEC with respect to the inclusion of the independent accounting firm’s opinion on the audited financial statements of Q32 in any filing of the Registration Statement with the SEC.

(e) As promptly as practicable following the date of this Agreement and no later than fifteen (15) Business Days after the date of this Agreement, Q32 shall deliver to Homology financial statements (including any related notes thereto) of Q32 and its consolidated Subsidiaries as of and for the fiscal years ended December 31, 2022 and 2021, with respect to which the PCAOB Auditor has substantially completed its audit work in accordance with the standards of the PCAOB, subject to providing the PCAOB Auditor’s report thereon for inclusion in the Registration Statement. As promptly as practicable following the date of this Agreement and no later than fifteen (15) Business Days after the date of this Agreement, Q32 shall deliver to Homology unaudited interim financial statements (including any related notes thereto) of Q32 and its consolidated Subsidiaries as of and for the nine months ended September 30, 2023 and 2022, with respect to which the PCAOB Auditor has substantially completed its review in accordance with the procedures specified by the PCAOB in AS 4105, Reviews of Interim Financial Information (the “interim review procedures”), for inclusion in the Registration Statement. All such financial statements included in the Registration Statement at the time of filing shall comply as to form in all material respects, shall be prepared in accordance with GAAP (as modified by the rules and regulations of the SEC) applied on a consistent basis throughout the periods involved, shall fairly present in all material respects the consolidated financial position at the date thereof and the results of its operations and cash flows as of and for the periods therein indicated and shall comply in all material respects with the applicable accounting requirements and with the rules and regulations of the SEC, the Exchange Act and the Securities Act applicable to a registrant, in effect as of the respective dates thereof.

5.8 Q32 Stockholder Written Consent.

(a) Promptly after the Registration Statement has been declared effective under the Securities Act, and in any event no later than two (2) Business Days thereafter, Q32 shall prepare, with the cooperation of Homology, and cause to be mailed to its stockholders an information statement, which shall include a copy of the Proxy Statement (the “Information Statement”), and the Q32 Stockholder Written Consent, in order to solicit the approval of Q32’s stockholders, including but not limited to Q32’s stockholders sufficient for the Required Q32 Stockholder Vote in lieu of a meeting pursuant to Section 228 of Delaware Law, for purposes of (i) adopting and approving this Agreement and the Contemplated Transactions, and (ii) acknowledging that the approval given thereby is irrevocable. Q32 shall use its reasonable best efforts to cause Q32’s stockholders sufficient for the Required Q32 Stockholder Vote to execute and deliver to Q32 the Q32 Stockholder Written Consent promptly following delivery thereof, and in any event no later than fifteen (15) days after the Registration Statement has been declared effective. Promptly following receipt of the duly executed Q32 Stockholder Written Consent, Q32 shall deliver a copy of the duly executed Q32 Stockholder Written Consent to Homology. Under no circumstances shall Q32 assert that any other approval or consent is necessary by its stockholders to approve this Agreement and the Contemplated Transactions.

 

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(b) Promptly following receipt of the Required Q32 Stockholder Vote, Q32 shall prepare and mail a notice to every stockholder of Q32 that did not execute the Q32 Stockholder Written Consent. Such notice shall (i) be a statement to the effect that the Q32 Board determined that the Merger is advisable in accordance with Section 251(b) of Delaware Law and in the best interests of the stockholders of Q32 and approved and adopted this Agreement, the Merger and the other Contemplated Transactions, and (ii) provide the stockholders of Q32 to whom it is sent with notice of the actions taken in the Q32 Stockholder Written Consent, including the adoption and approval of this Agreement, the Merger and the other Contemplated Transactions in accordance with Section 228(e) of Delaware Law and Q32’s Organizational Documents.

(c) Q32 agrees that: (i) the Q32 Board shall recommend that Q32’s stockholders vote to adopt and approve this Agreement and the Contemplated Transactions and shall use commercially reasonable efforts to solicit such approval within the time set forth in Section 5.8(a) (the recommendation of the Q32 Board that Q32’s stockholders vote to adopt and approve this Agreement being referred to as the “Q32 Board Recommendation”) and (ii) the Q32 Board Recommendation shall not be withdrawn or modified (and the Q32 Board shall not publicly propose to withdraw or modify the Q32 Board Recommendation) in a manner adverse to Homology, and no resolution by the Q32 Board or any committee thereof to withdraw or modify the Q32 Board Recommendation in a manner adverse to Homology or to adopt, approve or recommend (or publicly propose to adopt, approve or recommend) any Acquisition Proposal shall be adopted or proposed.

(d) Q32’s obligation to solicit the consent of its stockholders to sign the Q32 Stockholder Written Consent in accordance with Section 5.8(a) shall not be limited or otherwise affected by the commencement, disclosure, announcement or submission of any Superior Offer or other Acquisition Proposal.

5.9 Homology Stockholder Meeting.

(a) Homology shall take all action necessary under applicable Law to call, give notice of and hold a meeting of the holders of Homology Common Stock to consider and vote to approve this Agreement and the Contemplated Transactions, including the issuance of the shares of Homology Common Stock to the stockholders of Q32 pursuant to the terms of this Agreement and the Charter Amendment Proposal (collectively, the “Homology Stockholder Matters” and such meeting, the “Homology Stockholder Meeting”). The Homology Stockholder Meeting shall be held as promptly as practicable after the Registration Statement is declared effective under the Securities Act, and in any event no later than forty-five (45) days after the effective date of the Registration Statement. Homology shall take reasonable measures to ensure that all proxies solicited in connection with the Homology Stockholder Meeting are solicited in compliance with all applicable Law. Notwithstanding anything to the contrary contained herein, if on the date of the Homology Stockholder Meeting, or a date preceding the date on which the Homology Stockholder Meeting is scheduled, Homology reasonably believes that (i) it will not receive proxies sufficient to obtain the Required Homology Stockholder Vote, whether or not a quorum would be present or (ii) it will not have sufficient shares of Homology Common Stock represented (whether in person or by proxy) to constitute a quorum necessary to conduct the business of the Homology Stockholder Meeting, Homology may postpone or adjourn, or make one or more successive postponements or adjournments of, the Homology Stockholder Meeting as long as the date of the Homology Stockholder Meeting is not postponed or adjourned more than an aggregate of thirty (30) calendar days in connection with any postponements or adjournments.

(b) Homology agrees that, subject to Section 5.9(c): (i) the Homology Board shall recommend that the holders of Homology Common Stock vote to approve the Homology Stockholder Matters and shall use commercially reasonable efforts to solicit such approval within the timeframe set forth in Section 5.9(a) above, (ii) the Proxy Statement shall include a statement to the effect that the Homology Board recommends that Homology’s stockholders vote to approve the Homology Stockholder Matters (the recommendation of the Homology Board being referred to as the “Homology Board Recommendation”) and (iii) the Homology Board Recommendation shall not be withheld, amended, withdrawn or modified (and the Homology Board shall not publicly propose to withhold, amend, withdraw or modify the Homology Board Recommendation) in a manner

 

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adverse to Q32, and no resolution by the Homology Board or any committee thereof to withdraw or modify the Homology Board Recommendation in a manner adverse to Q32 or to adopt, approve or recommend (or publicly propose to adopt, approve or recommend) any Acquisition Proposal shall be adopted or proposed (the actions set forth in the foregoing clause (iii), collectively, a “Homology Board Adverse Recommendation Change”).

(c) Notwithstanding anything to the contrary contained in Section 5.9(b), and subject to compliance with Section 5.4 and Section 5.9, at any time prior to the approval of Homology Stockholder Matters by the Required Homology Stockholder Vote, Homology receives a bona fide written Superior Offer, the Homology Board may make a Homology Board Adverse Recommendation Change if, but only if, in the receipt of and on account of such Superior Offer, (i) the Homology Board determines in good faith, after consultation with its outside legal counsel, that the failure to make a Homology Board Adverse Recommendation Change would reasonably be expected to be inconsistent with its fiduciary duties under applicable Law, (ii) Homology has, and has caused its financial advisors and outside legal counsel to, during the Notice Period, negotiate with Q32 in good faith to make such adjustments to the terms and conditions of this Agreement so that such Acquisition Proposal ceases to constitute a Superior Offer and (iii) if after Q32 shall have delivered to Homology a written offer to alter the terms or conditions of this Agreement during the Notice Period (or if Q32 declines to do so), the Homology Board shall have determined in good faith, after consultation with its outside legal counsel, that the failure to withhold, amend, withdraw or modify the Homology Board Recommendation would reasonably be expected to be inconsistent with its fiduciary duties under applicable Law (after taking into account such alterations of the terms and conditions of this Agreement, if any); provided that (x) Q32 receives written notice from Homology confirming that the Homology Board has determined to change its recommendation during the Notice Period, which notice shall include a description in reasonable detail of the reasons for such Homology Board Adverse Recommendation Change, and written copies of any relevant proposed transaction agreements with any party making a potential Superior Offer, (y) during any Notice Period, Q32 shall be entitled to deliver to Homology one or more counterproposals to such Acquisition Proposal and Homology will, and cause its Representatives to, negotiate with Q32 in good faith (to the extent Q32 desires to negotiate) to make such adjustments in the terms and conditions of this Agreement so that the applicable Acquisition Proposal ceases to constitute a Superior Offer and (z) in the event of any material amendment to any Superior Offer (including any revision in price or percentage of the combined company that Homology’s stockholders would receive as a result of such potential Superior Offer), Homology shall be required to provide Q32 with notice of such material amendment and the Notice Period shall be extended, if applicable, to ensure that at least two (2) Business Days remain in the Notice Period following such notification during which the parties shall comply again with the requirements of this Section 5.9(c) and the Homology Board shall not make a Homology Board Adverse Recommendation Change prior to the end of such Notice Period as so extended (it being understood that there may be multiple extensions).

(d) Homology’s obligation to call, give notice of and hold the Homology Stockholder Meeting in accordance with Section 5.9(a) shall not be limited or otherwise affected by the commencement, disclosure, announcement or submission of any Superior Offer or Acquisition Proposal, or by any withdrawal or modification of the Homology Board Recommendation.

(e) Nothing contained in this Agreement shall prohibit Homology or the Homology Board from complying with Rules 14d-9 and 14e-2(a) promulgated under the Exchange Act; provided, however, that any disclosure made by Homology or the Homology Board pursuant to Rules 14d-9 and 14e-2(a) shall be limited to a statement that Homology is unable to take a position with respect to the bidder’s tender offer unless the Homology Board determines in good faith, after consultation with its outside legal counsel, that such statement would result in a breach of its fiduciary duties under applicable Law.

5.10 Efforts; Regulatory Approvals.

(a) The Parties shall use commercially reasonable efforts to consummate the Contemplated Transactions. Without limiting the generality of the foregoing, each Party: (i) shall make all filings and other submissions (if any) and give all notices (if any) required to be made and given by such Party in connection with the

 

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Contemplated Transactions, (ii) shall use commercially reasonable efforts to obtain each Consent (if any) reasonably required to be obtained (pursuant to any applicable Law or Contract, or otherwise) by such Party in connection with the Contemplated Transactions or for such Contract to remain in full force and effect, (iii) shall use commercially reasonable efforts to lift any injunction prohibiting, or any other legal bar to, the Contemplated Transactions and (iv) shall use commercially reasonable efforts to satisfy the conditions precedent to the consummation of this Agreement.

(b) Notwithstanding the generality of the foregoing, each Party shall use commercially reasonable efforts to file or otherwise submit, as soon as practicable after the date of this Agreement, all applications, notices, reports and other documents reasonably required to be filed by such Party with or otherwise submitted by such Party to any Governmental Authority with respect to the Contemplated Transactions, and to submit promptly any additional information requested by any such Governmental Authority.

5.11 Disclosures. Without limiting any Party’s obligations under the Confidentiality Agreement, no Party shall, and no Party shall permit any of its Subsidiaries or any of its Representative to, issue any press release or make any disclosure (to any customers or employees of such Party, to the public or otherwise) regarding the Contemplated Transactions unless: (a) the other Party shall have approved such press release or disclosure in writing, such approval not to be unreasonably conditioned, withheld or delayed; or (b) such Party shall have determined in good faith, upon the advice of outside legal counsel, that such disclosure is required by applicable Law and, to the extent practicable, before such press release or disclosure is issued or made, such Party advises the other Party of, and consults with the other Party regarding, the text of such press release or disclosure; provided, however, that each of Q32 and Homology may make any statement in response to questions by the press, analysts, investors or those attending industry conferences or financial analyst conference calls, so long as any such statements are consistent with previous press releases, public disclosures or public statements made by Q32 and Homology in compliance with this Section 5.11. Notwithstanding the foregoing, a Party need not consult with any other Parties in connection with such portion of any press release, public statement or filing to be issued or made pursuant to Section 5.9(d) or with an Acquisition Proposal, or Homology Board Adverse Recommendation Change with respect to Homology only pursuant to Section 5.9(e).

5.12 Homology Options. Prior to the Closing, the Homology Board shall have adopted appropriate resolutions and taken all other actions necessary and appropriate to provide (a) each outstanding Homology Option that is not a Homology ITM Option will be cancelled for no consideration and (b) that the vesting and exercisability of each unexpired, unexercised and unvested Homology ITM Option shall be accelerated in full, in each case, effective as of immediately prior to the Effective Time, contingent on the occurrence of the Closing.

5.13 Homology Restricted Stock Unit Awards. Prior to the Closing, the Homology Board shall have adopted appropriate resolutions and taken all other actions necessary and appropriate to provide that (a) the vesting of each outstanding and unvested Homology Restricted Stock Unit Award shall be accelerated in full effective as of immediately prior to the Effective Time, contingent on the occurrence of the Closing and (b) for each outstanding and unsettled Homology Restricted Stock Unit Award, the holder thereof shall receive, immediately prior to the Effective Time, a number of shares of Homology Common Stock equal to the number of vested and unsettled shares of Homology Common Stock underlying such Homology Restricted Stock Unit Award. Notwithstanding anything herein to the contrary, the Tax withholding obligations for each holder receiving shares of Homology Common Stock in accordance with the preceding sentence shall be satisfied by Homology withholding from issuance that number of shares of Homology Common Stock calculated by multiplying the maximum statutory withholding rate for such holder in connection with such issuance by the number of shares of Homology Common Stock to be issued in accordance with the preceding sentence, and rounding up to the nearest whole share and remitting such withholding in cash to the appropriate taxing authorities (the amount of such cash, the “RSU Withholding Amount”).

5.14 Homology ESPP. As soon as reasonably practicable following the date of this Agreement, the Homology Board shall adopt appropriate resolutions to provide that (a) no offering periods or purchase periods

 

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shall be commenced following or in addition to the offering period underway as of the date hereof under the Homology ESPP (the “Current Offering Period”), (b) no payroll deductions or other contributions shall be made or effected after the Current Offering Period with respect to the Homology ESPP, and (c) each Homology ESPP participant’s accumulated contributions under the Homology ESPP shall be returned to the participant in accordance with the terms of the Homology ESPP.

5.15 Indemnification of Officers and Directors.

(a) From the Effective Time through the sixth anniversary of the date on which the Effective Time occurs (or such period in which a D&O Indemnified Party (defined below) is asserting a claim for indemnification or other protections pursuant to this Section 5.15 to the extent arising prior to the end of such six-year period), each of Homology and the Surviving Corporation shall indemnify and hold harmless each person who is now, or has been at any time prior to the date hereof, or who becomes prior to the Effective Time, a director or officer of Homology or Q32, respectively (the “D&O Indemnified Parties”), against all claims, losses, liabilities, settlements, damages, judgments, fines and penalties and reasonable fees, costs and expenses, including attorneys’ fees and disbursements (collectively, “Costs”), incurred in connection with any claim, action, suit, proceeding or investigation, whether civil, criminal, administrative or investigative, formal or informal, arising out of or pertaining to the fact that the D&O Indemnified Party is or was a director or officer of Homology or of Q32, whether asserted or claimed prior to, at or after the Effective Time (including in connection with this Agreement or the Contemplated Transactions), in each case, to the fullest extent permitted under Delaware Law (including as it may be amended after the date of this Agreement to increase the extent to which a corporation may provide indemnification). Each D&O Indemnified Party will be entitled to advancement of fees, costs and expenses incurred in the defense of any such claim, action, suit, proceeding or investigation from each of Homology and the Surviving Corporation, jointly and severally, upon receipt by Homology or the Surviving Corporation from the D&O Indemnified Party of a request therefor; provided that any such person to whom fees, costs or expenses are advanced provides an undertaking to Homology, to the extent then required by Delaware Law, to repay such advances if it is ultimately determined that such person is not entitled to indemnification. Homology and the Surviving Corporation shall each cooperate with the D&O Indemnified Party in the defense of any actual or threatened claim, action, suit, proceeding or investigation.

(b) The provisions of Homology’s Organizational Documents with respect to indemnification, advancement of expenses and exculpation of present and former directors and officers of Homology that are presently set forth in Homology’s Organizational Documents shall not be amended, modified or repealed for a period of six years from the Effective Time in a manner that would adversely affect the rights thereunder of individuals who, at or prior to the Effective Time, were officers or directors of Homology, unless such modification is required by applicable Law. The Surviving Corporation’s Organizational Documents shall contain, and Homology shall cause the certificate of incorporation of the Surviving Corporation to so contain, provisions no less favorable with respect to indemnification, advancement of fees, costs and expenses and exculpation of future, present and former directors and officers as those presently set forth in Homology’s and Q32’s Organizational Documents, respectively.

(c) From and after the Effective Time, (i) the Surviving Corporation shall fulfill and honor in all respects the obligations of Q32 to its D&O Indemnified Parties as of immediately prior to the Effective Time pursuant to any indemnification, exculpation and advancement provisions under Q32’s Organizational Documents and pursuant to any indemnification agreements between Q32 and such D&O Indemnified Parties, with respect to any claim, action, suit, proceeding or investigation, whether civil, criminal, administrative or investigative, formal or informal, arising out of matters occurring at or prior to the Effective Time, whether asserted or claimed prior to, at or after the Effective Time (including in connection with this Agreement or the Contemplated Transactions), and (ii) Homology shall fulfill and honor in all respects the obligations of Homology to its D&O Indemnified Parties as of immediately prior to the Closing pursuant to any indemnification provisions under Homology’s Organizational Documents and pursuant to any indemnification agreements between Homology and such D&O Indemnified Parties, with respect to claims arising out of matters occurring at or prior to the Effective Time.

 

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(d) From and after the Effective Time, Homology and the Surviving Corporation shall maintain directors’ and officers’ liability insurance policies, with an effective date as of the Closing Date, on commercially available terms and conditions and with coverage limits customary for U.S. public companies similarly situated to Homology. In addition, Homology shall purchase, prior to the Effective Time, a six-year prepaid non-cancellable extension of directors’ and officers’ liability coverage of Homology’s existing directors’ and officers’ insurance policies for a claims reporting or discovery period of at least six years from and after the Effective Time with respect to any claim related to any period of time at or prior to the Effective Time “Homology D&O Tail Coverage” with the same or substantially the same terms, conditions, retentions and limits of liability as the coverage provided under Homology’s existing policies as of the date of this Agreement with respect to any actual or alleged error, misstatement, misleading statement, act, omission, neglect, breach of duty or any matter claimed against a director or officer of Homology by reason of him or her serving in such capacity that existed or occurred at or prior to the Effective Time (including in connection with this Agreement or the Contemplated Transactions or in connection with Homology’s initial public offering of shares of Homology Common Stock).

(e) From and after the Effective Time, each of Homology and the Surviving Corporation, jointly and severally, shall pay all expenses, including reasonable fees, costs and expenses, including attorneys’ fees and disbursements in advance, that are incurred by the persons referred to in this Section 5.15 in connection with their enforcement of the rights provided to such persons in this Section 5.15.

(f) The provisions of this Section 5.15 are intended to be in addition to the rights otherwise available to the current and former officers and directors of Homology and Q32 by Law, charter, statute, bylaw or agreement, and shall operate for the benefit of, and shall be enforceable by, each of the D&O Indemnified Parties, their heirs and their Representatives.

(g) In the event Homology or the Surviving Corporation or any of their respective successors or assigns (i) consolidates with or merges into any other Person and shall not be the continuing or surviving corporation or entity of such consolidation or merger or (ii) transfers all or substantially all of its properties and assets to any Person, then, and in each such case, proper provision shall be made so that the successors and assigns of Homology or the Surviving Corporation, as the case may be, shall succeed to the obligations set forth in this Section 5.15. Homology shall cause the Surviving Corporation to perform all of the obligations of the Surviving Corporation under this Section 5.15.

5.16 Tax Matters.

(a) All transfer, documentary, sales, use, stamp, registration, excise, recording, registration value added and other such similar Taxes and fees (including any penalties and interest) that become payable by Q32 or Homology in connection with or by reason of the execution of this Agreement and the transactions contemplated hereby (collectively, “Transfer Taxes”) shall be borne and paid by Homology. The Person required by applicable law shall timely file any Tax Return or other document with respect to such Transfer Taxes.

(b) At the Closing, Q32 shall deliver to Homology a certificate pursuant to Treasury Regulations Sections 1.1445-2(c) and 1.897-2(h), together with a form of notice to the IRS in accordance with the requirements of Treasury Regulations Section 1.897-2(h), in each case, in form and substance reasonably acceptable to Homology; provided, however, that Homology’s only remedy for Q32’s failure to provide such form or certificate will be to withhold from the payments to be made pursuant to this Agreement any required withholding Tax under Section 1445 of the Code, and Q32’s failure to provide any such form or certificate will not be deemed to be a failure of the conditions set forth in Article VI to have been met.

(c) The parties intend that, for United States federal income tax purposes, the Merger will qualify for the Intended Tax Treatment. The Merger shall be reported by the parties for all Tax purposes in accordance with the foregoing, unless otherwise required by a Governmental Authority as a result of a “determination” within the meaning of Section 1313(a) of the Code. The parties shall cooperate with each other and their respective counsel

 

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to document and support the Tax treatment of the Merger as qualifying for the Intended Tax Treatment, including by taking the actions described on Section 5.16(c) of the Q32 Disclosure Schedule.

5.17 Listing. At or prior to the Effective Time, Homology shall use commercially reasonable efforts to (a) maintain a listing on Nasdaq until the Effective Time and, to the extent required by the rules and regulations of Nasdaq, obtain approval of the listing of the combined company on Nasdaq; (b) to the extent required by the rules and regulations of Nasdaq, prepare and submit to Nasdaq a notification form for the listing of the shares of Homology Common Stock to be issued in connection with the Contemplated Transactions and to cause such shares to be approved for listing; (c) prepare and timely submit to Nasdaq a notification form of the Nasdaq Reverse Split and to submit a copy of the amendment to Homology’s certificate of incorporation to effect the Nasdaq Reverse Split and other amendments contemplated by Section 2.4 certified by the Secretary of State of the State of Delaware, to Nasdaq on or before the Closing Date; and (d) to the extent required by Nasdaq Marketplace Rule 5110, assist Q32 in preparing and filing an initial listing application for the Homology Common Stock on Nasdaq (the “Nasdaq Listing Application”). The Party not filing the Nasdaq Listing Application will cooperate with the other Party as reasonably requested by such filing Party with respect to the Nasdaq Listing Application and promptly furnish to such filing Party all information concerning itself and its stockholders that may be required or reasonably requested in connection with any action contemplated by this Section 5.17.

5.18 Legends. Homology shall be entitled to place appropriate legends on the book entries and/or certificates evidencing any shares of Homology Common Stock to be received in the Merger by equityholders of Q32 who may be considered “affiliates” of Homology for purposes of Rules 144 and 145 under the Securities Act reflecting the restrictions set forth in Rules 144 and 145 and to issue appropriate stop transfer instructions to the transfer agent for Homology Common Stock.

5.19 Officers and Directors.

(a) Directors and Officers of Homology.

(i) Homology shall cause, effective as of the Effective Time, the Homology Board to consist of nine (9) individuals, which shall consist of (A) seven (7) members selected by the Q32 Board (each, a “Q32 Designee”) and (B) two (2) members selected by the Homology Board as set forth on Section 5.19(a)(i) of the Homology Disclosure Schedule (each, a “Homology Designee”). Q32 shall deliver a notice to Homology identifying each of the Q32 Designees at least three (3) Business Days prior to the Closing Date. If any Q32 Designee or Homology Designee is unable or unwilling to serve as director of Homology, the Party appointing such Person shall designate a successor.

(ii) Homology shall cause the directors and officers of Homology listed on Section 5.19(a)(ii) of the Homology Disclosure Schedule to sign written resignations in forms reasonably satisfactory to Q32, dated on or before the Closing Date and effective as of the Effective Time.

(iii) Immediately following the Effective Time, Homology shall take all necessary action to appoint the officers of Q32 to become the equivalent officers of Homology until the earlier of their resignation or removal or until their respective successors are duly elected or appointed and qualified, as the case may be.

(b) Directors and Officers of the Surviving Corporation.

(i) The Parties shall take all actions necessary (A) so that from and after the Effective Time, the Surviving Corporation’s board of directors shall be constituted with those members as set forth on Section 5.19(b) of the Homology Disclosure Schedule and (B) to secure the resignations of the existing members of the committees of the Surviving Corporation, if any.

(ii) The Parties shall take all actions necessary so that the officers of Q32 immediately prior to the Effective Time shall, from and after the Effective Time, be the officers of the Surviving Corporation, until the earlier of their resignation or removal or until their respective successors are duly elected or appointed and qualified, as the case may be.

 

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(iii) On the Closing Date, the Surviving Corporation shall enter into customary indemnification agreements reasonably satisfactory to Q32 with each individual to be appointed to, or serving on, the board of directors of the Surviving Corporation upon the Closing, which indemnification agreements shall continue to be effective following the Closing.

5.20 Termination of Certain Agreements and Rights. Q32 shall cause any stockholder agreements, voting agreements, registration rights agreements, co-sale agreements and any other similar Contracts between Q32 and any holders of Q32 Capital Stock, including any such Contract granting any Person investor rights, rights of first refusal, registration rights or director registration rights to be terminated immediately prior to the Effective Time, without any liability being imposed on the part of Homology or the Surviving Corporation.

5.21 Section 16 Matters. Prior to the Effective Time, Homology shall take all such steps as may be required to cause any acquisitions of Homology Common Stock and any options to purchase Homology Common Stock in connection with the Contemplated Transactions, by each individual who is reasonably expected to become subject to the reporting requirements of Section 16(a) of the Exchange Act with respect to Homology, to be exempt under Rule 16b-3 promulgated under the Exchange Act.

5.22 Allocation Certificate. Q32 will prepare and deliver to Homology at least two (2) Business Days prior to the Closing Date a certificate signed by an executive officer of Q32 in a form reasonably acceptable to Homology setting forth (as of immediately prior to the Effective Time) (a) each holder of Q32 Capital Stock, (b) such holder’s name and address, (c) the number and type of Q32 Capital Stock held as of the Closing Date for each such holder and (d) the number of shares of Homology Common Stock to be issued to such holder pursuant to this Agreement in respect of the Q32 Capital Stock held by such holder as of immediately prior to the Effective Time, and (e) each investor in the Concurrent Financing, the total investment to be made by such investor in the Concurrent Financing, the percentage of the Concurrent Financing Proceeds represented by such stockholder’s investment in the Concurrent Financing, and the number of shares of Homology Common Stock to be issued to such holder pursuant to this Agreement (the “Allocation Certificate”). For the avoidance of doubt, the Allocation Certificate shall be prepared in good faith, in accordance with the Organizational Documents of Q32 and contracts applicable to Q32 Capital Stock, Q32 Options and Q32 Warrants], and shall show each holder’s percentage ownership interest in Q32 on a fully diluted basis.

5.23 Nasdaq Reverse Split. Homology shall submit to Homology’s stockholders at the Homology Stockholder Meeting the Reverse Stock Split Proposal, and the Parties shall take such other actions as shall be reasonably necessary to effectuate the Nasdaq Reverse Split.

5.24 Obligations of Merger Sub. Homology will take all action necessary to cause Merger Sub to perform its obligations under this Agreement and to consummate the Merger on the terms and conditions set forth in this Agreement.

5.25 Takeover Statutes. If any takeover statute is or may become applicable to the Contemplated Transactions, each of Q32, the Q32 Board, Homology and the Homology Board, as applicable, shall grant such approvals and take such actions as are necessary, to the extent permitted by Law, so that the Contemplated Transactions may be consummated as promptly as practicable on the terms contemplated by this Agreement and otherwise act to eliminate or minimize the effects of such statute or regulation on the Contemplated Transactions.

5.26 Stockholder Litigation. Each Party shall keep the other Party reasonably informed regarding any stockholder litigation against Homology or any of its directors relating to this Agreement or the Contemplated Transactions (“Transaction Litigation”). Prior to the Closing, Homology shall have the right to control the defense and settlement of any Transaction Litigation, but shall reasonably consult with Q32 and consider any advice from Q32 and its Representatives with respect to Transaction Litigation. Homology shall promptly advise Q32 of the initiation of, and shall keep Q32 reasonably apprised of any material developments in connection with, any such Transaction Litigation.

 

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5.27 Concurrent Financing.

(a) Subject to the terms and conditions of this Agreement, Q32 shall use commercially reasonable efforts to obtain the Concurrent Financing on the terms and conditions described in the Subscription Agreement and satisfy the conditions to the Concurrent Financing as described in the Subscription Agreement and shall not permit any termination, amendment or modification to be made to, or any waiver of any provision under, or any replacement of, the Subscription Agreement if such termination, amendment, modification, waiver or replacement (i) reduces the aggregate amount of the Concurrent Financing or (ii) imposes new or additional conditions or otherwise expands, amends or modifies any of the conditions to the receipt of the Concurrent Financing, or otherwise expands, amends or modifies any other provision of the Subscription Agreement, in a manner that would reasonably be expected to (x) delay or prevent the funding of the Concurrent Financing (or satisfaction of the conditions to the Concurrent Financing) at or substantially simultaneously with the Closing or (y) adversely impact the ability of Q32 to enforce its rights against other parties to the Subscription Agreement. Q32 shall promptly deliver to Homology copies of any such termination, amendment, modification, waiver or replacement.

(b) Q32 shall use commercially reasonable efforts (i) to maintain in effect the Subscription Agreement, (ii) to enforce its rights under the Subscription Agreement and (iii) to comply with its obligations under the Subscription Agreement.

(c) Q32 shall give Homology prompt notice (i) of any breach or default by any party to the Subscription Agreement or definitive agreements related to the Concurrent Financing of which Q32 becomes aware, (ii) of the receipt of any written notice or other written communication from any Purchaser with respect to any (x) actual breach, default, termination or repudiation by any party to the Subscription Agreement or definitive agreements related to the Concurrent Financing of any provisions of the Subscription Agreement or definitive agreements related to the Concurrent Financing or (y) material dispute or disagreement relating to the Concurrent Financing with respect to the obligation to fund the Concurrent Financing at or substantially simultaneously with the Closing, and (iii) if at any time for any reason Q32 believes in good faith that it will not be able to obtain all or any portion of the Concurrent Financing on the terms and conditions, in the manner or from the sources contemplated by the Subscription Agreement or definitive agreements related to the Concurrent Financing. Q32 shall promptly provide information reasonably requested by Homology relating to the circumstances referred to in clauses (i), (ii) or (iii) of the immediately preceding sentence.

5.28 Homology Equity Plans.

(a) Prior to the effectiveness of the Form S-4, Homology will use commercially reasonable efforts to cause the Homology Board to adopt the 2024 Equity Incentive Plan, subject to the Closing and the approval of the stockholders of Homology prior to the Effective Time and effective as of the Effective Time, and at Q32’s expense, will include provisions in the Proxy Statement for the stockholders of Homology to approve the 2024 Equity Incentive Plan. Subject to the approval of the 2024 Equity Incentive Plan by the stockholders of Homology prior to the Effective Time, Homology shall file with the SEC, promptly after the Effective Time and at Q32’s expense, a registration statement on Form S-8 (or any successor form), if available for use by Homology, relating to the shares of Homology Common Stock issuable with respect to the 2024 Equity Incentive Plan.

(b) Prior to the effectiveness of the Form S-4, Homology will use commercially reasonable efforts to cause the Homology Board to adopt the 2024 ESPP, subject to the Closing and the approval of the stockholders of Homology prior to the Effective Time and effective as of the Effective Time, and at Q32’s expense, will include provisions in the Proxy Statement for the stockholders of Homology to approve the 2024 ESPP. Subject to the approval of the 2024 ESPP by the stockholders of Homology prior to the Effective Time, Homology shall file with the SEC, promptly after the Effective Time and at Q32’s expense, a registration statement on Form S-8 (or any successor form), if available for use by Homology, relating to the shares of Homology Common Stock issuable with respect to the 2024 ESPP.

 

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(c) For the avoidance of doubt, approval of the 2024 Plans by the stockholders of Homology shall not be a condition to Closing.

5.29 Homology 401(k) Plan. Unless otherwise requested by Q32 in writing at least ten (10) Business Days prior to the Closing Date, the Homology Board or an authorized committee thereof shall take (or cause to be taken) all actions to adopt such resolutions as may be necessary or appropriate to terminate, effective no later than the day prior to the Closing Date but subject to the Closing, any Homology Employee Plan that contains a cash or deferred arrangement intended to qualify under Section 401(k) of the Code (a “Homology 401(k) Plan”). If Homology is required to terminate any Homology 401(k) Plan, then Homology shall provide to Q32 prior to the Closing Date written evidence of the adoption by the Homology Board or an authorized committee thereof of resolutions authorizing the termination of such Homology 401(k) Plan (the form and substance of which shall be subject to the reasonable prior review and approval of Q32, not to be unreasonably withheld, conditioned or delayed).

ARTICLE VI

CONDITIONS TO CONSUMMATION OF THE MERGER

6.1 Conditions Precedent to Obligations of Each Party. The obligations of each Party to effect the Merger and otherwise consummate the Contemplated Transactions are subject to the satisfaction or, to the extent permitted by applicable law, the written waiver by each of the Parties, at or prior to the Closing, of each of the following conditions:

(a) No temporary restraining order, preliminary or permanent injunction or other Order preventing the consummation of the Contemplated Transactions shall have been issued by any court of competent jurisdiction or other Governmental Authority of competent jurisdiction and remain in effect and there shall not be any Law which has the effect of making the consummation of the Contemplated Transactions illegal.

(b) Homology shall have obtained the Required Homology Stockholder Vote, and Q32 shall have obtained the Required Q32 Stockholder Vote.

(c) The approval of the listing of the additional shares of Homology Common Stock on Nasdaq shall have been obtained and the shares of Homology Common Stock to be issued in the Merger pursuant to this Agreement shall have been approved for listing (subject to official notice of issuance) on Nasdaq.

(d) The Subscription Agreement shall be in full force and effect and cash proceeds of not less than the Concurrent Investment Amount shall have been received by Homology, or will be received by Homology substantially simultaneously with the Closing, in connection with the consummation of the transactions contemplated by the Subscription Agreement.

(e) The Homology Lock-Up Agreements and Q32 Lock-Up Agreements will continue to be in full force and effect as of immediately following the Effective Time.

(f) The Registration Statement shall have become effective in accordance with the provisions of the Securities Act, and shall not be subject to any stop order or proceeding seeking a stop order with respect to such Registration Statement that has not been withdrawn.

(g) Q32 shall have effected the Q32 Preferred Stock Conversion.

 

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6.2 Conditions Precedent to Obligations of Q32. The obligations of Q32 to effect the Merger and otherwise consummate the Contemplated Transactions are subject to the satisfaction or, to the extent permitted by applicable law, the written waiver by Q32, at or prior to the Closing, of each of the following conditions:

(a) Each of the Homology Fundamental Representations shall have been true and correct in all respects as of the date of this Agreement and shall be true and correct in all material respects on and as of the Closing Date with the same force and effect as if made on and as of such date (except to the extent such representations and warranties are specifically made as of a particular date, in which case such representations and warranties shall be true and correct as of such date). The Homology Capitalization Representations shall have been true and correct in all respects as of the date of this Agreement and shall be true and correct on and as of the Closing Date with the same force and effect as if made on and as of such date, except, in each case, (x) for such inaccuracies which are de minimis, individually or in the aggregate or (y) for those representations and warranties which address matters only as of a particular date (which representations and warranties shall have been true and correct, subject to the qualifications as set forth in the preceding clause (x), as of such particular date). The representations and warranties of Homology and Merger Sub contained in this Agreement (other than the Homology Fundamental Representations and the Homology Capitalization Representations) shall have been true and correct in all respects as of the date of this Agreement and shall be true and correct on and as of the Closing Date with the same force and effect as if made on the Closing Date except (i) in each case, or in the aggregate, where the failure to be true and correct would not reasonably be expected to have a Homology Material Adverse Effect (without giving effect to any references therein to any Homology Material Adverse Effect or other materiality qualifications), (ii) where the failure to be true and correct as of the Closing Date is the result of (a) a Legacy Asset Disposition or (b) abandonment of or failure to file, prosecute or maintain any Abandoned Homology Legacy IP Rights (provided that this clause (ii) shall not cover any liability related to Legacy IP Rights (e.g., liability for infringement) that remains with the Company following Closing or (iii) for those representations and warranties which address matters only as of a particular date (which representations shall have been true and correct, subject to the qualifications as set forth in the preceding clause (i) and (ii), as of such particular date) (it being understood that, for purposes of determining the accuracy of such representations and warranties, any update of or modification to the Homology Disclosure Schedule made or purported to have been made after the date of this Agreement shall be disregarded).

(b) Homology and Merger Sub shall have performed or complied in all material respects with all covenants and agreements required to be performed or complied with by them under this Agreement at or prior to the Closing Date.

(c) A Homology Material Adverse Effect shall not have occurred since the date of this Agreement and be continuing.

(d) Homology shall have delivered to Q32 a certificate (the “Homology Closing Certificate”), dated the Closing Date and signed by an executive officer of Homology, certifying to the effect that the conditions set forth in Sections 6.2(a) and 6.2(b) have been satisfied.

6.3 Conditions Precedent to Obligations of Homology. The obligations of Homology and Merger Sub to effect the Merger and otherwise consummate the Contemplated Transactions are subject to the satisfaction or, to the extent permitted by applicable law, the written waiver by Homology, at or prior to the Closing, of each of the following conditions:

(a) Each of the Q32 Fundamental Representations shall have been true and correct in all respects as of the date of this Agreement and shall be true and correct in all material respects on and as of the Closing Date with the same force and effect as if made on and as of such date (except to the extent such representations and warranties are specifically made as of a particular date, in which case such representations and warranties shall be true and correct as of such date). The Q32 Capitalization Representations shall have been true and correct in all respects as of the date of this Agreement and shall be true and correct on and as of the Closing Date with the

 

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same force and effect as if made on and as of such date, except, in each case, (x) for such inaccuracies which are de minimis, individually or in the aggregate or (y) for those representations and warranties which address matters only as of a particular date (which representations and warranties shall have been true and correct, subject to the qualifications as set forth in the preceding clause (x), as of such particular date). The representations and warranties of Q32 contained in this Agreement (other than the Q32 Fundamental Representations and the Q32 Capitalization Representations) shall have been true and correct in all respects as of the date of this Agreement and shall be true and correct on and as of the Closing Date with the same force and effect as if made on the Closing Date except (i) in each case, or in the aggregate, where the failure to be so true and correct would not reasonably be expected to have a Q32 Material Adverse Effect (without giving effect to any references therein to any Q32 Material Adverse Effect or other materiality qualifications) or (ii) for those representations and warranties which address matters only as of a particular date (which representations shall have been true and correct, subject to the qualifications as set forth in the preceding clause (a), as of such particular date) (it being understood that, for purposes of determining the accuracy of such representations and warranties, any update of or modification to the Q32 Disclosure Schedule made or purported to have been made after the date of this Agreement shall be disregarded).

(b) Q32 shall have performed and complied in all material respects with all covenants and agreements required to be performed or complied with by it under this Agreement at or prior to the Closing Date.

(c) A Q32 Material Adverse Effect shall not have occurred since the date of this Agreement and be continuing.

(d) Q32 shall have delivered to Homology a certificate (the “Q32 Closing Certificate”), dated the Closing Date and signed by an executive officer of Q32, certifying to the effect that (i) the conditions set forth in Sections 6.3(a), 6.3(b) and 6.3(c) have been satisfied and (ii) the information set forth in the Allocation Certificate delivered by Q32 in accordance with Section 5.22 is true and accurate in all respects as of the Closing Date.

6.4 Frustration of Closing Conditions. Neither Homology nor Merger Sub may rely on the failure of any conditions set forth in Sections 6.1 or 6.3 to be satisfied if the primary cause of such failure was the failure of Homology or Merger Sub to perform any of its obligations under this Agreement. Q32 may not rely on the failure of any conditions set forth in Sections 6.1 or 6.2 to be satisfied if the primary cause of such failure was the failure of Q32 to perform any of its obligations under this Agreement.

ARTICLE VII

CLOSING DELIVERIES

7.1 Closing Deliveries of Q32. The obligations of Homology and Merger Sub to effect the Merger and otherwise consummate the Contemplated Transactions are subject to Homology receiving the following documents, each of which shall be in full force and effect, or the written waiver by Homology of delivery:

(a) the Q32 Stockholder Written Consents;

(b) the Allocation Certificate; and

(c) the Q32 Closing Certificate.

7.2 Closing Deliveries of Homology. The obligations of Q32 to effect the Merger and otherwise consummate the Contemplated Transactions are subject to Q32 receiving the following documents, each of which shall be in full force and effect, or the written waiver by Q32 of delivery:

(a) the Homology Net Cash Schedule;

(b) the Homology Closing Certificate;

 

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(c) subject to Section 2.5, the executed CVR Agreement; and

(d) written resignations in forms satisfactory to Q32, dated as of the Closing Date and effective as of the Closing executed by the officers and directors of Homology who are not to continue as officers or directors of Homology pursuant to Section 5.19 hereof.

ARTICLE VIII

TERMINATION

8.1 Termination. This Agreement may be terminated, and the Merger and the Contemplated Transactions may be abandoned at any time prior to the Effective Time, whether before or (subject to the terms hereof) after approval of the Homology Stockholder Matters by Homology’s stockholders, unless otherwise specified below:

(a) by mutual written consent of Homology and Q32;

(b) by either Homology and Q32 if the Merger shall not have been consummated by May 16, 2024 (subject to possible extension as provided in this Section 8.1(b), the “Outside Date”); provided, however, that the right to terminate this Agreement under this Section 8.1(b) shall not be available to Homology or Q32 if such Party’s action or failure to act has been a principal cause of the failure of the Merger to occur on or before the Outside Date and such action or failure to act constitutes a breach of this Agreement, provided, further, however, that, in the event that the SEC has not declared effective under the Securities Act the Registration Statement by the date which is twenty-five (25) days prior to the Outside Date, then either Homology or Q32 shall be entitled to extend the Outside Date for an additional ninety (90) days;

(c) by either Homology and Q32 if a court of competent jurisdiction or other Governmental Authority shall have issued a final and nonappealable Order, or shall have taken any other action, having the effect of permanently restraining, enjoining or otherwise prohibiting the Contemplated Transactions;

(d) by Homology if the Required Q32 Stockholder Vote shall not have been obtained and evidence thereof delivered to Homology within fifteen (15) days of the Registration Statement becoming effective in accordance with the provisions of the Securities Act; provided, however, that once the Required Q32 Stockholder Vote has been obtained, Homology may not terminate this Agreement pursuant to this Section 8.1(d);

(e) by either Homology or Q32 if (i) the Homology Stockholder Meeting (including any adjournments and postponements thereof) shall have been held and completed and Homology’s stockholders shall have taken a final vote on the Homology Stockholder Matters and (ii) the Homology Stockholder Matters shall not have been approved at the Homology Stockholder Meeting (or at any adjournment or postponement thereof) by the Required Homology Stockholder Vote;

(f) by Q32 (at any time prior to the approval of the Homology Stockholder Matters by the Required Homology Stockholder Vote) if a Homology Triggering Event shall have occurred;

(g) by Homology (at any time prior to the adoption of this Agreement and the approval of the Contemplated Transactions by the Required Q32 Stockholder Vote) if a Q32 Triggering Event shall have occurred;

(h) by Q32, upon a breach of any representation, warranty, covenant or agreement set forth in this Agreement by Homology or Merger Sub or if any representation or warranty of Homology or Merger Sub shall have become inaccurate, in either case, such that the conditions set forth in Section 6.2(a) or Section 6.2(b) would not be satisfied as of the time of such breach or as of the time such representation or warranty shall have become inaccurate; provided that Q32 is not then in material breach of any representation, warranty, covenant or agreement under this Agreement; provided, further, that if such inaccuracy in Homology’s or Merger Sub’s representations and warranties or breach by Homology or Merger Sub is curable by Homology or Merger Sub, then this Agreement shall not terminate pursuant to this Section 8.1(h) as a result of such particular breach or inaccuracy until the expiration of a 30-day period commencing upon delivery of written notice from Q32 to

 

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Homology or Merger Sub of such breach or inaccuracy and its intention to terminate pursuant to this Section 8.1(h) (it being understood that this Agreement shall not terminate pursuant to this Section 8.1(h) as a result of such particular breach or inaccuracy if such breach by Homology or Merger Sub is cured prior to such termination becoming effective); or

(i) by Homology, upon a breach of any representation, warranty, covenant or agreement set forth in this Agreement by Q32 or if any representation or warranty of Q32 shall have become inaccurate, in either case, such that the conditions set forth in Section 6.3(a) or Section 6.3(b) would not be satisfied as of the time of such breach or as of the time such representation or warranty shall have become inaccurate; provided that Homology is not then in material breach of any representation, warranty, covenant or agreement under this Agreement; provided, further, that if such inaccuracy in Q32’s representations and warranties or breach by Q32 is curable by Q32 then this Agreement shall not terminate pursuant to this Section 8.1(i) as a result of such particular breach or inaccuracy until the expiration of a 30-day period commencing upon delivery of written notice from Homology to Q32 of such breach or inaccuracy and its intention to terminate pursuant to this Section 8.1(i) (it being understood that this Agreement shall not terminate pursuant to this Section 8.1(i) as a result of such particular breach or inaccuracy if such breach by Q32 is cured prior to such termination becoming effective).

The Party desiring to terminate this Agreement pursuant to this Section 8.1 (other than pursuant to Section 8.1(a)) shall give a notice of such termination to the other Party specifying the provisions hereof pursuant to which such termination is made and the basis therefor described in reasonable detail.

8.2 Effect of Termination. In the event of the termination of this Agreement as provided in Section 8.1, this Agreement shall be of no further force or effect; provided, however, that (a) this Section 8.2, Section 8.3, and Article IX shall survive the termination of this Agreement and shall remain in full force and effect and (b) the termination of this Agreement and the provisions of Section 8.3 shall not relieve any Party of any liability for fraud or for any willful and material breach of any representation, warranty, covenant, obligation or other provision contained in this Agreement.

8.3 Expenses; Termination Fees.

(a) Except as set forth in this Section 8.3 all fees and expenses incurred in connection with this Agreement and the Contemplated Transactions shall be paid by the Party incurring such expenses, whether or not the Merger is consummated; provided, however, that (i) Homology and Q32 shall pay the costs and expenses incurred in relation to the filings by the Parties under any antitrust Law applicable to this Agreement and the transactions contemplated hereby, and (ii) Homology and Q32 shall share equally all fees and expenses incurred in relation to the printing and filing with the SEC of the Registration Statement (including any financial statements and exhibits) and any amendments or supplements thereto and paid to a financial printer or the SEC.

(b) If (i) this Agreement is terminated by Homology or Q32 pursuant to Section 8.1(b), (ii) at any time after the date of this Agreement and prior to the Homology Stockholder Meeting an Acquisition Proposal with respect to Homology shall have been publicly announced, disclosed or otherwise communicated to the Homology Board (and shall not have been withdrawn) and (iii) within twelve (12) months after the date of such termination, Homology enters into a definitive agreement with respect to a Subsequent Transaction or consummates a Subsequent Transaction, then Homology shall pay to Q32, within four (4) Business Days after termination (or, if applicable, upon such entry into a definitive agreement and/or consummation of a Subsequent Transaction), a nonrefundable fee in an amount equal to $2,400,000.

(c) If this Agreement is terminated by Q32 pursuant to Section 8.1(f), then Homology shall pay to Q32 within four (4) Business Days after termination, a nonrefundable fee in an amount equal to $2,400,000.

(d) If this Agreement is terminated by Homology pursuant to Section 8.1(d) or Section 8.1(g), then Q32 shall pay to Homology, within four (4) Business Days after termination, a nonrefundable fee in an amount equal to $5,850,000.

 

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(e) If either Party fails to pay when due any amount payable by it under this Section 8.3, then (i) such Party shall reimburse the other Party for reasonable costs and expenses (including reasonable fees and disbursements of counsel) incurred in connection with the collection of such overdue amount and the enforcement by the other Party of its rights under this Section 8.3 and (ii) such Party shall pay to the other Party interest on such overdue amount (for the period commencing as of the date such overdue amount was originally required to be paid and ending on the date such overdue amount is actually paid to the other Party in full) at a rate per annum equal to the “prime rate” (as announced by Bank of America or any successor thereto) in effect on the date such overdue amount was originally required to be paid plus three percent.

(f) The Parties agree that, subject to Section 8.2, the payment of the fees and expenses set forth in this Section 8.3 shall be the sole and exclusive remedy of each Party following a termination of this Agreement under the circumstances described in this Section 8.3 that result in the payment of such fees, it being understood that in no event shall either Homology or Q32 be required to pay the individual fees or damages payable pursuant to this Section 8.3 on more than one occasion. Subject to Section 8.2, following the termination of this Agreement under the circumstances described in this Section 8.3 and the payment of the fees set forth in this Section 8.3 by a Party, (i) such Party shall have no further liability to the other Party in connection with or arising out of this Agreement or the termination thereof, any breach of this Agreement by the other Party giving rise to such termination, or the failure of the Contemplated Transactions to be consummated, (ii) no other Party or their respective Affiliates shall be entitled to bring or maintain any other claim, action or proceeding against such Party or seek to obtain any recovery, judgment or damages of any kind against such Party (or any partner, member, stockholder, director, officer, employee, Subsidiary, affiliate, agent or other representative of such Party) in connection with or arising out of this Agreement or the termination thereof, any breach by such Party giving rise to such termination or the failure of the Contemplated Transactions to be consummated and (iii) all other Parties and their respective Affiliates shall be precluded from any other remedy against such Party and its Affiliates, at law or in equity or otherwise, in connection with or arising out of this Agreement or the termination thereof, any breach by such Party giving rise to such termination or the failure of the Contemplated Transactions to be consummated. Each of the Parties acknowledges that (x) the agreements contained in this Section 8.3 are an integral part of the Contemplated Transactions, (y) without these agreements, the Parties would not enter into this Agreement and (z) any amount payable pursuant to this Section 8.3 is not a penalty, but rather is liquidated damages in a reasonable amount that will compensate the Parties in the circumstances in which such amount is payable.

ARTICLE IX

GENERAL PROVISIONS

9.1 Non-Survival of Representations and Warranties. The representations and warranties of Q32, Homology and Merger Sub contained in this Agreement or any certificate or instrument delivered pursuant to this Agreement shall terminate at the Effective Time, and only the covenants that by their terms survive the Effective Time and this Article IX shall survive the Effective Time.

9.2 Amendment. This Agreement may be amended with the approval of the respective boards of directors of Q32, Merger Sub and Homology at any time (whether before or after obtaining the Required Q32 Stockholder Vote and the Required Homology Stockholder Vote); provided, however, that after any such approval of this Agreement by a Party’s stockholders or members, no amendment shall be made which by Law requires further approval of such stockholders or members without the further approval of such stockholders or members. This Agreement may not be amended except by an instrument in writing signed on behalf of each of Q32, Merger Sub and Homology.

9.3 Waiver.

(a) Any provision hereof may be waived by the waiving Party solely on such Party’s own behalf, without the consent of any other Party. No failure on the part of any Party to exercise any power, right, privilege or

 

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remedy under this Agreement, and no delay on the part of any Party in exercising any power, right, privilege or remedy under this Agreement, shall operate as a waiver of such power, right, privilege or remedy; and no single or partial exercise of any such power, right, privilege or remedy shall preclude any other or further exercise thereof or of any other power, right, privilege or remedy.

(b) No Party shall be deemed to have waived any claim arising out of this Agreement, or any power, right, privilege or remedy under this Agreement, unless the waiver of such claim, power, right, privilege or remedy is expressly set forth in a written instrument duly executed and delivered on behalf of such Party and any such waiver shall not be applicable or have any effect except in the specific instance in which it is given.

9.4 Entire Agreement; Counterparts; Exchanges by Electronic Transmission or Facsimile. This Agreement and the other schedules, exhibits, certificates, instruments and agreements referred to in this Agreement constitute the entire agreement and supersede all prior agreements and understandings, both written and oral, among or between any of the Parties with respect to the subject matter hereof and thereof; provided, however, that the Confidentiality Agreement shall not be superseded and shall remain in full force and effect in accordance with its terms. This Agreement may be executed in several counterparts, each of which shall be deemed an original and all of which shall constitute one and the same instrument. The exchange of a fully executed Agreement (in counterparts or otherwise) by all Parties by facsimile or electronic transmission in PDF format shall be sufficient to bind the Parties to the terms and conditions of this Agreement.

9.5 Applicable Law; Jurisdiction. This Agreement shall be governed by, and construed in accordance with, the laws of the State of Delaware, regardless of the laws that might otherwise govern under applicable principles of conflicts of laws. In any action or proceeding between any of the Parties arising out of or relating to this Agreement or any of the Contemplated Transactions, each of the Parties: irrevocably and unconditionally (a) consents and submits to the exclusive jurisdiction and venue of the Court of Chancery of the State of Delaware or, to the extent such court does not have subject matter jurisdiction, the Superior Court of the State of Delaware or the United States District Court for the District of Delaware, (b) agrees that all claims in respect of such action or proceeding shall be heard and determined exclusively in accordance with clause (a) of this Section 9.5, (c) waives any objection to laying venue in any such action or proceeding in such courts, (d) waives any objection that such courts are an inconvenient forum or do not have jurisdiction over any Party, (e) agrees that service of process upon such Party in any such action or proceeding shall be effective if notice is given in accordance with Section 9.7 of this Agreement and (f) irrevocably and unconditionally waives the right to trial by jury.

9.6 Assignability. This Agreement shall be binding upon, and shall be enforceable by and inure solely to the benefit of, the Parties and their respective successors and permitted assigns; provided, however, that neither this Agreement nor any of a Party’s rights or obligations hereunder may be assigned or delegated by such Party without the prior written consent of the other Party, and any attempted assignment or delegation of this Agreement or any of such rights or obligations by such Party without the other Party’s prior written consent shall be void and of no effect.

9.7 Notices. All notices and other communications hereunder shall be in writing and shall be deemed to have been duly delivered and received hereunder (a) one (1) Business Day after being sent for next Business Day delivery, fees prepaid, via a reputable international overnight courier service, (b) upon delivery in the case of delivery by hand or (c) on the date delivered in the place of delivery if sent by email or facsimile (with a written or electronic confirmation of delivery) prior to 6:00 p.m. New York City time, otherwise on the next succeeding Business Day, in each case to the intended recipient as set forth below:

if to Homology or Merger Sub:

Homology Medicines, Inc.

One Patriots Park

Bedford, MA 01730

Attention: Paul Alloway

Email: [***]

 

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with a copy to (which shall not constitute notice):

Latham & Watkins LLP

200 Clarendon Street

Boston, MA 02116

Attention: Peter Handrinos; Leah Sauter

Email: [***]

if to Q32:

Q32 Bio Inc.

830 Winter St.

Waltham, MA 02451

Attention: Jodie Morrison

Email: [***]

with a copy to (which shall not constitute notice):

Goodwin Procter LLP

100 Northern Avenue

Boston, MA 02210

Attention: John T. Haggerty; Jacqueline Mercier; Tevia K. Pollard

Email: [***]

9.8 Cooperation. Each Party agrees to cooperate fully with the other Party and to execute and deliver such further documents, certificates, agreements and instruments and to take such other actions as may be reasonably requested by the other Party to evidence or reflect the Contemplated Transactions and to carry out the intent and purposes of this Agreement.

9.9 Severability. Any term or provision of this Agreement that is invalid or unenforceable in any situation in any jurisdiction shall not affect the validity or enforceability of the remaining terms and provisions of this Agreement or the validity or enforceability of the offending term or provision in any other situation or in any other jurisdiction. If a final judgment of a court of competent jurisdiction declares that any term or provision of this Agreement is invalid or unenforceable, the Parties agree that the court making such determination shall have the power to limit such term or provision, to delete specific words or phrases or to replace such term or provision with a term or provision that is valid and enforceable and that comes closest to expressing the intention of the invalid or unenforceable term or provision, and this Agreement shall be valid and enforceable as so modified. In the event such court does not exercise the power granted to it in the prior sentence, the Parties agree to replace such invalid or unenforceable term or provision with a valid and enforceable term or provision that will achieve, to the extent possible, the economic, business and other purposes of such invalid or unenforceable term or provision.

9.10 Other Remedies; Specific Performance. Except as otherwise provided herein, any and all remedies herein expressly conferred upon a Party will be deemed cumulative with and not exclusive of any other remedy conferred hereby, or by law or equity upon such Party, and the exercise by a Party of any one remedy will not preclude the exercise of any other remedy. The Parties agree that irreparable damage for which monetary damages, even if available, would not be an adequate remedy, would occur in the event that any of the provisions of this Agreement were not performed in accordance with their specific terms (including failing to take such actions as are required of it hereunder to consummate this Agreement) or were otherwise breached. It is accordingly agreed that the Parties shall be entitled to an injunction or injunctions to prevent breaches of this Agreement and to enforce specifically the terms and provisions hereof in any court of the United States or any state having jurisdiction, this being in addition to any other remedy to which they are entitled at law or in equity, and each of the Parties waives any bond, surety or other security that might be required of any other Party with respect thereto. Each of the Parties further agrees that it will not oppose the granting of an injunction, specific performance or other equitable relief on the basis that any other Party has an adequate remedy at law or that any award of specific performance is not an appropriate remedy for any reason at law or in equity.

 

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9.11 No Third-Party Beneficiaries.

Nothing in this Agreement, express or implied, is intended to or shall confer upon any Person (other than the Parties and the D&O Indemnified Parties to the extent of their respective rights pursuant to Section 5.15) any right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the date first above written.

 

HOMOLOGY MEDICINES, INC.
By:   /s/ Albert Seymour
Name: Albert Seymour
Title:   President and Chief Executive Officer
KENOBI MERGER SUB, INC.
By:   /s/ Paul Alloway
Name: Paul Alloway
Title:   President
Q32 BIO INC.
By:   /s/ Jodie Morrison
Name: Jodie Morrison
Title:   Chief Executive Officer

[Signature Page to Merger Agreement]

 

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Exhibit A

Form of Homology Stockholder Support Agreement

[Intentionally Omitted]


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Exhibit B

Form of Q32 Stockholder Support Agreement

[Intentionally Omitted]


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Exhibit C

Form of Homology Lock-Up Agreement

[Intentionally Omitted]


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Exhibit D

Form of Q32 Lock-Up Agreement

[Intentionally Omitted]


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Exhibit E

Form of CVR Agreement

[Intentionally Omitted]


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Annex B

Execution Version

HOMOLOGY MEDICINES, INC.

SUPPORT AGREEMENT

THIS SUPPORT AGREEMENT (this “Agreement”), dated as of November 16, 2023 is made by and among Homology Medicines, Inc., a Delaware corporation (“Homology”), Q32 Bio Inc., a Delaware corporation (the “Company”), and the undersigned holders (each a “Stockholder”) of shares of capital stock (the “Shares”) of Homology.

WHEREAS, Homology, Kenobi Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Homology (“Merger Sub”), and the Company, have entered into an Agreement and Plan of Merger, dated as of even date herewith (the “Merger Agreement”), providing for the merger of Merger Sub with and into the Company (the “Merger”);

WHEREAS, each Stockholder beneficially owns and has sole or shared voting power with respect to the number of Shares, and holds Homology Options to acquire the number of Shares, indicated opposite such Stockholder’s name on Schedule 1 attached hereto;

WHEREAS, as an inducement and a condition to the willingness of the Company to enter into the Merger Agreement, each Stockholder has agreed to enter into and perform this Agreement; and

WHEREAS, all capitalized terms used in this Agreement without definition herein shall have the meanings ascribed to them in the Merger Agreement.

NOW, THEREFORE, in consideration of, and as a condition to, the Company’s entering into the Merger Agreement, each Stockholder, Homology and the Company agree as follows:

1. Agreement to Vote Shares. Each Stockholder agrees that, prior to the Expiration Date (as defined in Section 2 below), at any meeting of the stockholders of Homology or any adjournment or postponement thereof, or in connection with any written consent of the stockholders (or any class or series of stockholders, as applicable) of Homology, with respect to the Merger, the Merger Agreement or any Acquisition Proposal, such Stockholder shall:

(a) appear at such meeting or otherwise cause the Shares and any New Shares (as defined in Section 3 below) to be counted as present thereat for purposes of calculating a quorum;

(b) from and after the date hereof until the Expiration Date, vote (or cause to be voted), or deliver a written consent (or cause a written consent to be delivered) covering all of the Shares and any New Shares that Stockholder shall be entitled to so vote: (i) in favor of (A) all of the Homology Stockholder Matters and (B) any matter that could reasonably be expected to facilitate the Merger, the Concurrent Financing and the Contemplated Transactions; (ii) against any action or agreement that would result in a breach of any representation, warranty, covenant or obligation of Homology in the Merger Agreement; (iii) against any Acquisition Proposal, or any agreement, transaction or other matter that is intended to, or would reasonably be expected to, impede, interfere with, delay, postpone, discourage or materially and adversely affect the consummation of the Merger, the Concurrent Financing and all of the other Contemplated Transactions; (iv) to approve any proposal to adjourn or postpone the meeting to a later date, if there are not sufficient votes for the adoption of the Merger Agreement on the date on which such meeting is held.

2. Expiration Date. As used in this Agreement, the term “Expiration Date” shall mean the earlier to occur of (a) the Effective Time, (b) such date and time as the Merger Agreement shall be terminated pursuant to Article VIII thereof or otherwise, (c) any amendment to the Merger Agreement is effected without the Stockholder’s written consent that increases the amount, or changes the form, of consideration payable to all stockholders of the Company pursuant to the terms of the Merger Agreement or (d) the mutual written agreement of the parties to terminate this Agreement.

 

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3. Additional Acquisitions. Each Stockholder agrees that any shares of capital stock or other equity securities of Homology that such Stockholder acquires or with respect to which such Stockholder otherwise acquires sole or shared voting power (including any proxy) after the execution of this Agreement and prior to the Expiration Date, whether by the exercise of any Homology Options or otherwise, including, without limitation, by gift, succession, in the event of a stock split or as a dividend or distribution of any Shares (“New Shares”), shall be subject to the terms and conditions of this Agreement to the same extent as if they constituted the Shares.

4. Agreement to Retain Shares. From and after the date hereof until the Expiration Date, each Stockholder shall not, directly or indirectly, (a) sell, assign, transfer, tender, or otherwise dispose of (including, without limitation, by the creation of any Liens (as defined in Section 5(c) below)) any Shares or any New Shares, (b) deposit any Shares or New Shares into a voting trust or enter into a voting agreement or similar arrangement with respect to such Shares or New Shares or grant any proxy or power of attorney with respect thereto (other than this Agreement), (c) enter into any Contract, option, commitment or other arrangement or understanding with respect to the direct or indirect sale, transfer, assignment or other disposition of (including, without limitation, by the creation of any Liens) any Shares or New Shares, or (d) take any action that would make any representation or warranty of such Stockholder contained herein untrue or incorrect or have the effect of preventing or disabling such Stockholder from performing such Stockholder’s obligations under this Agreement. Any action taken in violation of the foregoing sentence shall be null and void ab initio. Notwithstanding the foregoing, each Stockholder may make (1) transfers by will or by operation of Law or other transfers for estate-planning purposes, in which case this Agreement shall bind the transferee, (2) with respect to such Stockholder’s Homology Options (and any Shares underlying such Homology Options) which expire on or prior to the Expiration Date, transfers, sale, or other disposition of Shares to Homology (or effecting a “net exercise” of a Homology Option) as payment for the (i) exercise price of such Stockholder’s Homology Options and (ii) taxes applicable to the exercise of such Stockholder’s Homology Options, (3) if Stockholder is an entity, partnership or limited liability company, a transfer to one or more equityholders, partners or members of Stockholder or to an Affiliated person, corporation, trust or other Entity controlling or under common control with Stockholder, or if Stockholder is a trust, a transfer to a beneficiary, provided that in each such case the applicable transferee has signed a voting agreement in substantially the form hereof, (4) make transfers that occur by operation of law pursuant to a qualified domestic relations order or in connection with a divorce settlement, and (5) transfers, sales or other dispositions as the Company may otherwise agree in writing in its sole discretion. If any voluntary or involuntary transfer of any Shares covered hereby shall occur (including a transfer or disposition permitted by Section 4(1) through Section 4(5), sale by a Stockholder’s trustee in bankruptcy, or a sale to a purchaser at any creditor’s or court sale), the transferee (which term, as used herein, shall include any and all transferees and subsequent transferees of the initial transferee) shall take and hold such Shares subject to all of the restrictions, liabilities and rights under this Agreement, which shall continue in full force and effect, notwithstanding that such transferee is not a Stockholder and has not executed a counterpart hereof or joinder hereto.

5. Representations and Warranties of Stockholder. Each Stockholder hereby, severally but not jointly, represents and warrants to Homology and the Company as follows:

(a) If such Stockholder is an Entity: (i) such Stockholder is duly organized, validly existing and in good standing under the laws of the jurisdiction in which it is incorporated, organized or constituted, (ii) such Stockholder has all necessary power and authority to execute and deliver this Agreement, to perform such Stockholder’s obligations hereunder and to consummate the transactions contemplated hereby, and (iii) the execution and delivery of this Agreement, performance of such Stockholder’s obligations hereunder and the consummation of the transactions contemplated hereby by such Stockholder have been duly authorized by all necessary action on the part of such Stockholder and no other proceedings on the part of such Stockholder are necessary to authorize this Agreement, or to consummate the transactions contemplated hereby. If such Stockholder is an individual, such Stockholder has the legal capacity to execute and deliver this Agreement, to perform such Stockholder’s obligations hereunder and to consummate the transactions contemplated hereby;

 

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(b) this Agreement has been duly executed and delivered by or on behalf of such Stockholder and, to such Stockholder’s knowledge and assuming this Agreement constitutes a valid and binding agreement of the Company and Homology, constitutes a valid and binding agreement with respect to such Stockholder, enforceable against such Stockholder in accordance with its terms, except as enforcement may be limited by general principles of equity whether applied in a court of Law or a court of equity and by bankruptcy, insolvency and similar Laws affecting creditors’ rights and remedies generally;

(c) Stockholder has had the opportunity to review the Merger Agreement and this Agreement with counsel of Stockholder’s own choosing. Stockholder has had an opportunity to review with its own tax advisors the tax consequences of the Merger and the Contemplated Transactions. Stockholder understands that it must rely solely on its advisors and not on any statements or representations made by Homology, the Company or any of their respective agents or representatives. Stockholder understands that such Stockholder (and not Homology, the Company or the Surviving Corporation) shall be responsible for such Stockholder’s tax liability that may arise as a result of the Merger or the transactions contemplated by the Merger Agreement. Stockholder understands and acknowledges that the Company, Homology and Merger Sub are entering into the Merger Agreement in reliance upon Stockholder’s execution, delivery and performance of this Agreement.

(d) such Stockholder beneficially owns the number of Shares indicated opposite such Stockholder’s name on Schedule 1, which constitute all of the Shares owned by the Stockholder as of the date hereof. Such Stockholder will own any New Shares, free and clear of any liens, claims, charges or other encumbrances or restrictions of any kind whatsoever (“Liens”), and has sole or shared, and otherwise unrestricted, voting power with respect to such Shares or New Shares and none of the Shares or New Shares is subject to any voting trust or other agreement, arrangement or restriction with respect to the voting of the Shares or the New Shares, except as contemplated by this Agreement and the stockholder agreements and arrangements referenced in the Merger Agreement and except for customary arrangements with the Stockholder’s prime broker and/or custodian;

(e) to the knowledge of such Stockholder, the execution and delivery of this Agreement by such Stockholder does not, and the performance by such Stockholder of his, her or its obligations hereunder and the compliance by such Stockholder with any provisions hereof will not, violate or conflict with, result in a material breach of or constitute a default (or an event that with notice or lapse of time or both would become a material default) under, or give to others any rights of termination, amendment, acceleration or cancellation of, or result in the creation of any Liens on any Shares or New Shares pursuant to, any agreement, instrument, note, bond, mortgage, Contract, lease, license, permit or other obligation or any order, arbitration award, judgment or decree to which such Stockholder is a party or by which such Stockholder is bound, or any Law, statute, rule or regulation to which such Stockholder is subject or, in the event that such Stockholder is a corporation, partnership, trust or other Entity, any bylaw or other Organizational Document of such Stockholder; except for any of the foregoing as would not reasonably be expected to prevent or delay the performance by such Stockholder of his, her or its obligations under this Agreement in any material respect;

(f) the execution and delivery of this Agreement by such Stockholder does not, and the performance of this Agreement by such Stockholder does not and will not, require any consent, approval, authorization or permit of, or filing with or notification to, any Governmental Authority or regulatory authority by such Stockholder except for applicable requirements, if any, of the Exchange Act, and except where the failure to obtain such consents, approvals, authorizations or permits, or to make such filings or notifications, would not prevent or delay the performance by such Stockholder of his, her or its obligations under this Agreement in any material respect;

(g) no investment banker, broker, finder or other intermediary is entitled to a fee or commission from Homology or the Company in respect of this Agreement based upon any Contract made by or on behalf of such Stockholder; and

 

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(h) as of the date of this Agreement, there is no Legal Proceeding pending or, to the knowledge of such Stockholder, threatened against such Stockholder that would reasonably be expected to prevent or delay the performance by such Stockholder of his, her or its obligations under this Agreement in any material respect.

6. Irrevocable Proxy. Subject to the penultimate sentence of this Section 6, by execution of this Agreement, each Stockholder does hereby appoint the Company and any of its designees with full power of substitution and resubstitution, as such Stockholder’s true and lawful attorney and irrevocable proxy, to the fullest extent of such Stockholder’s rights with respect to the Shares, to vote and exercise all voting and related rights, including the right to sign such Stockholder’s name (solely in its capacity as a stockholder) to any Stockholder consent, if such Stockholder fails to vote his, her or its Shares solely with respect to the matters set forth in Section 1 hereof by 5:00 p.m. (Eastern Time) on the day immediately preceding the meeting date (or date upon which written consents are requested to be submitted), provided the Stockholder has received information regarding the meeting or request for written consent at least five (5) Business Days before such shareholder meeting or any consent solicitation or other vote taken of the Company’s stockholders. Each Stockholder intends this proxy to be irrevocable and coupled with an interest hereunder until the Expiration Date, hereby revokes any proxy previously granted by such Stockholder with respect to the Shares and represents that none of such previously-granted proxies are irrevocable. The Stockholder hereby affirms that the proxy set forth in this Section 6 is given in connection with, and granted in consideration of, and as an inducement to the Company, Homology and Merger Sub to enter into the Merger Agreement and that such proxy is given to secure the obligations of the Stockholder under Section 1. The irrevocable proxy and power of attorney granted herein shall survive the death or incapacity of such Stockholder and the obligations of such Stockholder shall be binding on such Stockholder’s heirs, personal representatives, successors, transferees and assigns. Each Stockholder hereby agrees not to grant any subsequent powers of attorney or proxies with respect to any Shares with respect to the matters set forth in Section 1 until after the Expiration Date. With respect to any Shares that are owned beneficially by Stockholder but are not held of record by Stockholder (other than shares beneficially owned by Stockholder that are held in the name of a bank, broker or nominee), Stockholder shall take all action necessary to cause the record holder of such Shares to grant the irrevocable proxy and take all other actions provided for in this Section 6 with respect to such Shares. Notwithstanding anything contained herein to the contrary, this irrevocable proxy shall automatically terminate upon the Expiration Date.

7. No Legal Actions. Each Stockholder will not in its capacity as a stockholder of Homology bring, commence, institute, maintain, prosecute or voluntarily aid any Legal Proceeding which (i) challenges the validity or seeks to enjoin the operation of any provision of this Agreement or (ii) alleges that the execution and delivery of this Agreement by such Stockholder, either alone or together with the other voting agreements and proxies to be delivered in connection with the execution of the Merger Agreement, or the approval of the Merger Agreement and the Contemplated Transactions by the Homology Board, constitutes a breach of any fiduciary duty of the Homology Board or any member thereof.

8. Other Remedies; Specific Performance. Except as otherwise provided herein, any and all remedies herein expressly conferred upon a party will be deemed cumulative with, and not exclusive of, any other remedy conferred hereby, or by Law or equity upon such party, and the exercise by a party of any one remedy will not preclude the exercise of any other remedy. The parties hereto agree that irreparable damage would occur in the event that any of the provisions of this Agreement were not performed in accordance with their specific terms or were otherwise breached. It is accordingly agreed that the parties shall be entitled to an injunction or injunctions to prevent breaches of this Agreement and to enforce specifically the terms and provisions hereof without the need of posting bond in any court of the United States or any state having jurisdiction, this being in addition to any other remedy to which they are entitled at Law or in equity.

9. Directors and Officers. This Agreement shall apply to each Stockholder solely in such Stockholder’s capacity as a stockholder of Homology and/or holder of Homology Options and not in such Stockholder’s capacity as a director, officer or employee of Homology or any of its Subsidiaries or in such Stockholder’s capacity as a trustee or fiduciary of any employee benefit plan or trust. Notwithstanding any provision of this

 

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Agreement to the contrary, nothing in this Agreement shall (or require Stockholder to attempt to) limit or restrict a director and/or officer of Homology in the exercise of his or her fiduciary duties consistent with the terms of the Merger Agreement as a director and/or officer of Homology or in his or her capacity as a trustee or fiduciary of any employee benefit plan or trust or prevent or be construed to create any obligation on the part of any director and/or officer of Homology or any trustee or fiduciary of any employee benefit plan or trust from taking any action in his or her capacity as such director, officer, trustee and/or fiduciary.

10. No Ownership Interest. Nothing contained in this Agreement shall be deemed to vest in the Company any direct or indirect ownership or incidence of ownership of or with respect to any Shares. All rights, ownership and economic benefits of and relating to the Shares shall remain vested in and belong to such Stockholder, and the Company does not have authority to manage, direct, superintend, restrict, regulate, govern, or administer any of the policies or operations of Homology or exercise any power or authority to direct such Stockholder in the voting of any of the Shares, except as otherwise provided herein.

11. Termination. This Agreement shall terminate and shall have no further force or effect as of the Expiration Date. Notwithstanding the foregoing, upon termination or expiration of this Agreement, no party shall have any further obligations or liabilities under this Agreement; provided, however, nothing set forth in this Section 11 or elsewhere in this Agreement shall relieve any party from liability for any fraud or for any willful and material breach of this Agreement prior to termination hereof.

12. Further Assurances. Each Stockholder shall, from time to time, execute and deliver, or cause to be executed and delivered, such additional or further consents, documents and other instruments as the Company or Homology may reasonably request for the purpose of effectively carrying out the transactions contemplated by this Agreement and the Contemplated Transactions.

13. Disclosure. Each Stockholder hereby agrees that Homology and the Company may publish and disclose in the Proxy Statement, any prospectus filed with any regulatory authority in connection with the Contemplated Transactions and any related documents filed with such regulatory authority and as otherwise required by Law, such Stockholder’s identity and ownership of Shares and the nature of such Stockholder’s commitments, arrangements and understandings under this Agreement and may further file this Agreement as an exhibit to the Proxy Statement or prospectus or in any other filing made by Homology or the Company as required by Law or the terms of the Merger Agreement, including with the SEC or other regulatory authority, relating to the Contemplated Transactions, all subject to prior review and a reasonable opportunity to comment by Stockholder’s counsel. Prior to the Closing, each Stockholder shall not, and shall use its reasonable best efforts to cause its representatives not to, directly or indirectly, make any press release, public announcement or other public communication regarding the Merger without the prior written consent of Homology and the Company, provided that the foregoing shall not limit or affect any actions taken by such Stockholder (or any affiliated officer or director of such Stockholder) that would be permitted to be taken by such Stockholder, Homology or the Company pursuant to the Merger Agreement; provided, further, that the foregoing shall not effect any actions of Stockholder the prohibition of which would be prohibited under applicable Law and shall not prohibit Stockholder or its affiliates from making any publicly-available filings required by applicable law, regulation or legal process.

14. Notice. All notices and other communications hereunder shall be in writing and shall be deemed given if delivered personally or sent by overnight courier (providing proof of delivery), by facsimile transmission (providing confirmation of transmission) or by electronic transmission (providing confirmation of transmission) to the Company or Homology, as the case may be, in accordance with Section 9.7 of the Merger Agreement and to each Stockholder at his, her or its address or email address (providing confirmation of transmission) set forth on Schedule 1 attached hereto (or at such other address for a party as shall be specified by like notice).

 

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15. Severability. Any term or provision of this Agreement that is invalid or unenforceable in any situation in any jurisdiction shall not affect the validity or enforceability of the remaining terms and provisions of this Agreement or the validity or enforceability of the offending term or provision in any other situation or in any other jurisdiction. If a final judgment of a court of competent jurisdiction declares that any term or provision of this Agreement is invalid or unenforceable, the parties hereto agree that the court making such determination shall have the power to limit such term or provision, to delete specific words or phrases or to replace such term or provision with a term or provision that is valid and enforceable and that comes closest to expressing the intention of the invalid or unenforceable term or provision, and this Agreement shall be valid and enforceable as so modified. In the event such court does not exercise the power granted to it in the prior sentence, the parties hereto agree to replace such invalid or unenforceable term or provision with a valid and enforceable term or provision that will achieve, to the extent possible, the economic, business and other purposes of such invalid or unenforceable term or provision.

16. Assignability. This Agreement shall be binding upon, and shall be enforceable by and inure solely to the benefit of, the parties hereto and their respective successors and assigns; provided, however, that neither this Agreement nor any of a party’s rights or obligations hereunder may be assigned or delegated by such party without the prior written consent of the other parties hereto, and any attempted assignment or delegation of this Agreement or any of such rights or obligations by such party without the other party’s prior written consent shall be void and of no effect. Nothing in this Agreement, express or implied, is intended to or shall confer upon any Person (other than the parties hereto) any right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.

17. No Waivers. No waivers of any breach of this Agreement extended by the Company or Homology to such Stockholder shall be construed as a waiver of any rights or remedies of the Company or Homology, as applicable, with respect to any other stockholder of Homology who has executed an agreement substantially in the form of this Agreement with respect to Shares held or subsequently held by such stockholder or with respect to any subsequent breach of Stockholder or any other such stockholder of Homology. No waiver of any provisions hereof by any party shall be deemed a waiver of any other provisions hereof by any such party, nor shall any such waiver be deemed a continuing waiver of any provision hereof by such party.

18. Applicable Law; Jurisdiction. This Agreement shall be governed by, and construed in accordance with, the Laws of the state of Delaware, regardless of the Laws that might otherwise govern under applicable principles of conflicts of Laws. In any action or Legal Proceeding between any of the parties arising out of or relating to this Agreement, each of the parties: (i) irrevocably and unconditionally consents and submits to the exclusive jurisdiction and venue of the Court of Chancery of the state of Delaware or to the extent such court does not have subject matter jurisdiction, the Superior Court of the State of Delaware or the United States District Court for the District of Delaware, (ii) agrees that all claims in respect of such action or Legal Proceeding shall be heard and determined exclusively in accordance with clause (i) of this Section 18, (iii) waives any objection to laying venue in any such action or Legal Proceeding in such courts, (iv) waives any objection that such courts are an inconvenient forum or do not have jurisdiction over any party, and (v) agrees that service of process upon such party in any such action or Legal Proceeding shall be effective if notice is given in accordance with Section 14 of this Agreement. Each party irrevocably consents to service of process inside or outside the territorial jurisdiction of the courts referred to in this Section 18 in the manner provided for notices in Section 14. Nothing in this Agreement will affect the right of any party to serve process in any other manner permitted by applicable Law.

19. Waiver of Jury Trial. The parties hereto hereby waive any right to trial by jury with respect to any action or Legal Proceeding related to or arising out of this Agreement, any document executed in connection herewith and the matters contemplated hereby and thereby.

20. No Agreement Until Executed. Irrespective of negotiations among the parties or the exchanging of drafts of this Agreement, this Agreement shall not constitute or be deemed to evidence a Contract, agreement, arrangement or understanding between the parties hereto unless and until (a) the Homology Board has approved,

 

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for purposes of any applicable anti-takeover Laws and regulations and any applicable provision of the certificate of incorporation of Homology, the Merger Agreement and the Contemplated Transactions, (b) the Merger Agreement is executed by all parties thereto, and (c) this Agreement is executed by all parties hereto.

21. Entire Agreement; Counterparts; Exchanges by Electronic Transmission. This Agreement and the other agreements referred to in this Agreement constitute the entire agreement and supersede all prior agreements and understandings, both written and oral, among or between any of the parties with respect to the subject matter hereof and thereof. This Agreement may be executed in several counterparts, each of which shall be deemed an original and all of which shall constitute one and the same instrument. The exchange of a fully executed Agreement (in counterparts or otherwise) by all parties by facsimile or electronic transmission via “.pdf” shall be sufficient to bind the parties to the terms and conditions of this Agreement.

22. Amendment. This Agreement may not be amended, supplemented or modified, and no provisions hereof may be modified or waived, except by an instrument in writing signed on behalf of each party hereto; provided, however, that the rights or obligations of any Stockholder may be waived, amended or otherwise modified in a writing signed by Homology, the Company and such Stockholder.

23. Fees and Expenses. Except as otherwise specifically provided herein, the Merger Agreement or any other agreement contemplated by the Merger Agreement to which a party hereto is a party, each party hereto shall bear its own expenses in connection with this Agreement and the transactions contemplated hereby.

24. Voluntary Execution of Agreement. This Agreement is executed voluntarily and without any duress or undue influence on the part or behalf of the parties. Each of the parties hereby acknowledges, represents and warrants that (i) it has read and fully understood the Merger Agreement, this Agreement and the implications and consequences thereof; (ii) it has been represented in the preparation, negotiation, and execution of this Agreement by legal counsel of its own choice, or it has made a voluntary and informed decision to decline to seek such counsel; and (iii) it is fully aware of the legal and binding effect of this Agreement.

25. Definition of Merger Agreement. For purposes of this Agreement, the term “Merger Agreement” may include such agreement as amended or modified as long as such amendments or modifications (a) do not (i) change the form or amount of consideration payable under the Merger Agreement, (ii) extend the Outside Date past May 16, 2024 (other than any extension provided for in Section 8.1(b) of the Merger Agreement with respect to the Registration Statement), or (iii) otherwise change the terms and conditions of the Merger, the Concurrent Financing or the other Contemplated Transaction in a manner materially adverse to such Stockholder or (b) have been agreed to in writing by such Stockholder.

26. Construction.

(a) For purposes of this Agreement, whenever the context requires: the singular number shall include the plural, and vice versa; the masculine gender shall include the feminine and neuter genders; the feminine gender shall include the masculine and neuter genders; and the neuter gender shall include masculine and feminine genders.

(b) The parties hereto agree that any rule of construction to the effect that ambiguities are to be resolved against the drafting party shall not be applied in the construction or interpretation of this Agreement.

(c) As used in this Agreement, the words “include” and “including,” and variations thereof, shall not be deemed to be terms of limitation, but rather shall be deemed to be followed by the words “without limitation.”

(d) Except as otherwise indicated, all references in this Agreement to “Sections,” and “Schedules” are intended to refer to Sections of this Agreement and Schedules to this Agreement, respectively.

 

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(e) The underlined headings contained in this Agreement are for convenience of reference only, shall not be deemed to be a part of this Agreement and shall not be referred to in connection with the construction or interpretation of this Agreement.

[Remainder of Page has Intentionally Been Left Blank]

 

 

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EXECUTED as of the date first above written.
    [STOCKHOLDER]
    Signature:                                                                

[Signature Page to Homology Stockholder Support Agreement]


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EXECUTED as of the date first above written.

 

HOMOLOGY MEDICINES, INC.
By:  

 

Name:
Title:
Q32 BIO INC.
By:  

 

Name:
Title:

[Signature Page to Homology Stockholder Support Agreement]


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SCHEDULE 1

[Intentionally Omitted]


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Annex C

Final Form

Q32 BIO INC.

SUPPORT AGREEMENT

THIS SUPPORT AGREEMENT (this “Agreement”), dated as of November 16, 2023 is made by and among Homology Medicines, Inc., a Delaware corporation (“Homology”), Q32 Bio Inc., a Delaware corporation (the “Company”), and the undersigned holders (each a “Stockholder”) of shares of capital stock (the “Shares”) of the Company.

WHEREAS, Homology, Kenobi Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Homology (“Merger Sub”), and the Company, have entered into an Agreement and Plan of Merger, dated as of even date herewith (the “Merger Agreement”), providing for the merger of Merger Sub with and into the Company (the “Merger”);

WHEREAS, each Stockholder beneficially owns and has sole or shared voting power with respect to the number of Shares, and holds Q32 Options to acquire the number of Shares, indicated opposite such Stockholder’s name on Schedule 1 attached hereto;

WHEREAS, as an inducement and a condition to the willingness of the Company to enter into the Merger Agreement, each Stockholder has agreed to enter into and perform this Agreement; and

WHEREAS, all capitalized terms used in this Agreement without definition herein shall have the meanings ascribed to them in the Merger Agreement.

NOW, THEREFORE, in consideration of, and as a condition to, the Company’s entering into the Merger Agreement, each Stockholder, Homology and the Company agree as follows:

1. Agreement to Vote Shares. Each Stockholder agrees that, prior to the Expiration Date (as defined in Section 2 below), at any meeting of the stockholders of the Company or any adjournment or postponement thereof, or in connection with any written consent of the stockholders (or any class or series of stockholders, as applicable) of the Company, with respect to the Merger, the Merger Agreement or any Acquisition Proposal, such Stockholder shall:

(a) appear at such meeting or otherwise cause the Shares and any New Shares (as defined in Section 3 below) to be counted as present thereat for purposes of calculating a quorum;

(b) from and after the date hereof until the Expiration Date, vote (or cause to be voted), or deliver a written consent (or cause a written consent to be delivered) covering all of the Shares and any New Shares that Stockholder shall be entitled to so vote: (i) in favor of (A) all of the matters set forth in the Q32 Stockholder Written Consent [, which Q32 Stockholder Written Consent shall be in a form acceptable to Stockholder]1 and (B) any matter that could reasonably be expected to facilitate the Merger, the Concurrent Financing and the Contemplated Transactions; (ii) against any action or agreement that would result in a breach of any representation, warranty, covenant or obligation of the Company in the Merger Agreement; (iii) against any Acquisition Proposal, or any agreement, transaction or other matter or action that is intended to, or would reasonably be expected to, impede, interfere with, delay, postpone, discourage or materially and adversely affect the consummation of the Merger, the Concurrent Financing and all of the other Contemplated Transactions; (iv) to approve any proposal to adjourn or postpone the meeting to a later date, if there are not sufficient votes for the adoption of the Merger Agreement on the date on which such meeting is held; and (v) to the extent applicable, in favor of an election to convert all of the Company Preferred Stock held by Stockholder into Company Common Stock [in accordance with the provisions of the Company’s certificate of incorporation as in effect on the date hereof].1 Stockholder shall not take or commit or agree to take any action inconsistent with the foregoing.

 

 

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2. Expiration Date. As used in this Agreement, the term “Expiration Date” shall mean the earlier to occur of (a) the Effective Time, (b) such date and time as the Merger Agreement shall be terminated pursuant to Article VIII thereof or otherwise, (c) any amendment to the Merger Agreement is effected without the Stockholder’s written consent that [(i)] 1 decreases the amount, or changes the form, of consideration payable to all stockholders of the Company pursuant to the terms of the Merger Agreement or [(ii) otherwise changes the terms and conditions of the Merger, the Concurrent Financing or the other Contemplated Transaction in a manner materially adverse to such Stockholder,]1 (d) the mutual written agreement of the parties to terminate this Agreement [or (e) the one year anniversary of the date of this Agreement].1

3. Additional Acquisitions. Each Stockholder agrees that any shares of capital stock or other equity securities of the Company that such Stockholder acquires or with respect to which such Stockholder otherwise acquires sole or shared voting power (including any proxy) after the execution of this Agreement and prior to the Expiration Date, whether by the exercise of any Q32 Options, Q32 Warrants or otherwise, including, without limitation, by gift, succession, in the event of a stock split or as a dividend or distribution of any Shares (“New Shares”), shall be subject to the terms and conditions of this Agreement to the same extent as if they constituted the Shares.

4. Agreement to Retain Shares. From and after the date hereof until the Expiration Date, each Stockholder shall not, directly or indirectly, (a) sell, assign, transfer, tender, or otherwise dispose of (including, without limitation, by the creation of any Liens (as defined in Section 5(c) below)) any Shares or any New Shares, (b) deposit any Shares or New Shares into a voting trust or enter into a voting agreement or similar arrangement with respect to such Shares or New Shares or grant any proxy or power of attorney with respect thereto (other than this Agreement), (c) enter into any Contract, option, commitment or other arrangement or understanding with respect to the direct or indirect sale, transfer, assignment or other disposition of (including, without limitation, by the creation of any Liens) any Shares or New Shares, or (d) take any action that would make any representation or warranty of such Stockholder contained herein untrue or incorrect or have the effect of preventing or disabling such Stockholder from performing such Stockholder’s obligations under this Agreement. Any action taken in violation of the foregoing sentence shall be null and void ab initio. Notwithstanding the foregoing, each Stockholder may make (1) transfers by will or by operation of Law or other transfers for estate-planning purposes, in which case this Agreement shall bind the transferee, (2) with respect to such Stockholder’s Q32 Options (and any Shares underlying such Q32 Options) which expire on or prior to the Expiration Date, transfers, sale, or other disposition of Shares to the Company (or effecting a “net exercise” of a Q32 Option) as payment for the (i) exercise price of such Stockholder’s Q32 Options and (ii) taxes applicable to the exercise of such Stockholder’s Q32 Options, (3) if Stockholder is an entity, partnership or limited liability company, a transfer to one or more equityholders, partners or members of Stockholder or to an Affiliated person, corporation, trust or other Entity controlling or under common control with Stockholder [(including, for the avoidance of doubt, a fund managed by the same manager or managing member or general partner or management company or by an entity controlling, controlled by or under common control with such manager or managing member or general partner or management company of the undersigned)]1, or if Stockholder is a trust, a transfer to a beneficiary, provided that in each such case the applicable transferee has signed a voting agreement in substantially the form hereof, (4) make transfers that occur by operation of law pursuant to a qualified domestic relations order or in connection with a divorce settlement, and (5) transfers, sales or other dispositions as the Company may otherwise agree in writing in its sole discretion. If any voluntary or involuntary transfer of any Shares covered hereby shall occur (including a transfer or disposition permitted by Section 4(1) through Section 4(5), sale by a Stockholder’s trustee in bankruptcy, or a sale to a purchaser at any creditor’s or court sale), the transferee (which term, as used herein, shall include any and all transferees and subsequent transferees of the initial transferee) shall take and hold such Shares subject to all of the restrictions, liabilities and rights under this Agreement, which shall continue in full force and effect, notwithstanding that such transferee is not a Stockholder and has not executed a counterpart hereof or joinder hereto.

 

 

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5. Representations and Warranties of Stockholder. Each Stockholder hereby, severally but not jointly, represents and warrants to Homology and the Company as follows:

(a) If such Stockholder is an Entity: (i) such Stockholder is duly organized, validly existing and in good standing under the laws of the jurisdiction in which it is incorporated, organized or constituted, (ii) such Stockholder has all necessary power and authority to execute and deliver this Agreement, to perform such Stockholder’s obligations hereunder and to consummate the transactions contemplated hereby, and (iii) the execution and delivery of this Agreement, performance of such Stockholder’s obligations hereunder and the consummation of the transactions contemplated hereby by such Stockholder have been duly authorized by all necessary action on the part of such Stockholder and no other proceedings on the part of such Stockholder are necessary to authorize this Agreement, or to consummate the transactions contemplated hereby. If such Stockholder is an individual, such Stockholder has the legal capacity to execute and deliver this Agreement, to perform such Stockholder’s obligations hereunder and to consummate the transactions contemplated hereby;

(b) this Agreement has been duly executed and delivered by or on behalf of such Stockholder and, to such Stockholder’s knowledge and assuming this Agreement constitutes a valid and binding agreement of the Company and Homology, constitutes a valid and binding agreement with respect to such Stockholder, enforceable against such Stockholder in accordance with its terms, except as enforcement may be limited by general principles of equity whether applied in a court of Law or a court of equity and by bankruptcy, insolvency and similar Laws affecting creditors’ rights and remedies generally;

(c) Stockholder has had the opportunity to review the Merger Agreement, including the provisions relating to the payment and allocation of the consideration to be paid to the stockholders of the Company, and this Agreement with counsel of Stockholder’s own choosing. Stockholder has had an opportunity to review with its own tax advisors the tax consequences of the Merger and the Contemplated Transactions. Stockholder understands that it must rely solely on its advisors and not on any statements or representations made by Homology, the Company or any of their respective agents or representatives [, except as set forth in the Subscription Agreement (with respect to those Stockholders participating in the Concurrent Financing)]1. Stockholder understands that such Stockholder (and not Homology, the Company or the Surviving Corporation) shall be responsible for such Stockholder’s tax liability that may arise as a result of the Merger or the transactions contemplated by the Merger Agreement. Stockholder understands and acknowledges that the Company, Homology and Merger Sub are entering into the Merger Agreement in reliance upon Stockholder’s execution, delivery and performance of this Agreement.

(d) such Stockholder beneficially owns the number of Shares indicated opposite such Stockholder’s name on Schedule 1, which constitute all of the Shares owned by the Stockholder as of the date hereof. Such Stockholder will own any New Shares, free and clear of any liens, claims, charges or other encumbrances or restrictions of any kind whatsoever (“Liens”), and has sole or shared, and otherwise unrestricted, voting power with respect to such Shares or New Shares and none of the Shares or New Shares is subject to any voting trust or other agreement, arrangement or restriction with respect to the voting of the Shares or the New Shares, except as contemplated by this Agreement and the stockholder agreements and arrangements referenced in the Merger Agreement and except for customary arrangements with the Stockholder’s prime broker and/or custodian;

(e) to the knowledge of such Stockholder, the execution and delivery of this Agreement by such Stockholder does not, and the performance by such Stockholder of his, her or its obligations hereunder and the compliance by such Stockholder with any provisions hereof will not, violate or conflict with, result in a material breach of or constitute a default (or an event that with notice or lapse of time or both would become a material default) under, or give to others any rights of termination, amendment, acceleration or cancellation of, or result in the creation of any Liens on any Shares or New Shares pursuant to, any agreement, instrument, note, bond, mortgage, Contract, lease, license, permit or other obligation or any order, arbitration award, judgment or decree to which such Stockholder is a party or by which such

 

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Stockholder is bound, or any Law, statute, rule or regulation to which such Stockholder is subject or, in the event that such Stockholder is a corporation, partnership, trust or other Entity, any bylaw or other Organizational Document of such Stockholder; except for any of the foregoing as would not reasonably be expected to prevent or delay the performance by such Stockholder of his, her or its obligations under this Agreement in any material respect;

(f) the execution and delivery of this Agreement by such Stockholder does not, and the performance of this Agreement by such Stockholder does not and will not, require any consent, approval, authorization or permit of, or filing with or notification to, any Governmental Authority or regulatory authority by such Stockholder except for applicable requirements, if any, of the Exchange Act, and except where the failure to obtain such consents, approvals, authorizations or permits, or to make such filings or notifications, would not prevent or delay the performance by such Stockholder of his, her or its obligations under this Agreement in any material respect;

(g) no investment banker, broker, finder or other intermediary is entitled to a fee or commission from Homology or the Company in respect of this Agreement based upon any Contract made by or on behalf of such Stockholder; and

(h) as of the date of this Agreement, there is no Legal Proceeding pending or, to the knowledge of such Stockholder, threatened against such Stockholder that would reasonably be expected to prevent or delay the performance by such Stockholder of his, her or its obligations under this Agreement in any material respect.

6. Irrevocable Proxy. Subject to the penultimate sentence of this Section 6, by execution of this Agreement, each Stockholder does hereby appoint the Company and any of its designees with full power of substitution and resubstitution, as such Stockholder’s true and lawful attorney and irrevocable proxy, to the fullest extent of such Stockholder’s rights with respect to the Shares, to vote and exercise all voting and related rights, including the right to sign such Stockholder’s name (solely in its capacity as a stockholder) to any Stockholder consent, if such Stockholder fails to vote his, her or its Shares solely with respect to the matters set forth in Section 1 [(b)]1 hereof by 5:00 p.m. (Eastern Time) on the day immediately preceding the meeting date (or date upon which written consents are requested to be submitted), provided the Stockholder has received information regarding the meeting or request for written consent at least five (5) Business Days before such shareholder meeting or any consent solicitation or other vote taken of the Company’s stockholders. Each Stockholder intends this proxy to be irrevocable and coupled with an interest hereunder until the Expiration Date, hereby revokes any proxy previously granted by such Stockholder with respect to the Shares and represents that none of such previously-granted proxies are irrevocable. The Stockholder hereby affirms that the proxy set forth in this Section 6 is given in connection with, and granted in consideration of, and as an inducement to the Company, Homology and Merger Sub to enter into the Merger Agreement and that such proxy is given to secure the obligations of the Stockholder under Section 1. The irrevocable proxy and power of attorney granted herein shall survive the death or incapacity of such Stockholder and the obligations of such Stockholder shall be binding on such Stockholder’s heirs, personal representatives, successors, transferees and assigns. Each Stockholder hereby agrees not to grant any subsequent powers of attorney or proxies with respect to any Shares with respect to the matters set forth in Section 1 until after the Expiration Date. With respect to any Shares that are owned beneficially by Stockholder but are not held of record by Stockholder (other than shares beneficially owned by Stockholder that are held in the name of a bank, broker or nominee), Stockholder shall take all action necessary to cause the record holder of such Shares to grant the irrevocable proxy and take all other actions provided for in this Section 6 with respect to such Shares. Notwithstanding anything contained herein to the contrary, this irrevocable proxy shall automatically terminate upon the Expiration Date.

7. Waiver of Appraisal Rights. Each Stockholder hereby waives, and agrees not to exercise or assert, any appraisal rights under applicable Law, including Section 262 of Delaware Law, in connection with the Merger.

 

 

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8. No Legal Actions. Each Stockholder will not in its capacity as a stockholder of the Company bring, commence, institute, maintain, prosecute or voluntarily aid any Legal Proceeding which (i) challenges the validity or seeks to enjoin the operation of any provision of this Agreement or (ii) alleges that the execution and delivery of this Agreement by such Stockholder, either alone or together with the other voting agreements and proxies to be delivered in connection with the execution of the Merger Agreement, or the approval of the Merger Agreement and the Contemplated Transactions by the Company Board, constitutes a breach of any fiduciary duty of the Q32 Board or any member thereof.

9. Other Remedies; Specific Performance. Except as otherwise provided herein, any and all remedies herein expressly conferred upon a party will be deemed cumulative with, and not exclusive of, any other remedy conferred hereby, or by Law or equity upon such party, and the exercise by a party of any one remedy will not preclude the exercise of any other remedy. The parties hereto agree that irreparable damage would occur in the event that any of the provisions of this Agreement were not performed in accordance with their specific terms or were otherwise breached. It is accordingly agreed that the parties shall be entitled to an injunction or injunctions to prevent breaches of this Agreement and to enforce specifically the terms and provisions hereof without the need of posting bond in any court of the United States or any state having jurisdiction, this being in addition to any other remedy to which they are entitled at Law or in equity.

10. Directors and Officers. This Agreement shall apply to each Stockholder solely in such Stockholder’s capacity as a stockholder of the Company and/or holder of Q32 Options and/or Q32 Warrants not in such Stockholder’s capacity as a director, officer or employee of the Company or any of its Subsidiaries or in such Stockholder’s capacity as a trustee or fiduciary of any employee benefit plan or trust. Notwithstanding any provision of this Agreement to the contrary, nothing in this Agreement shall (or require Stockholder to attempt to) limit or restrict a director and/or officer of the Company in the exercise of his or her fiduciary duties consistent with the terms of the Merger Agreement as a director and/or officer of the Company or in his or her capacity as a trustee or fiduciary of any employee benefit plan or trust or prevent or be construed to create any obligation on the part of any director and/or officer of the Company or any trustee or fiduciary of any employee benefit plan or trust from taking any action in his or her capacity as such director, officer, trustee and/or fiduciary.

11. No Ownership Interest. Nothing contained in this Agreement shall be deemed to vest in the Company any direct or indirect ownership or incidence of ownership of or with respect to any Shares. All rights, ownership and economic benefits of and relating to the Shares shall remain vested in and belong to such Stockholder, and the Company does not have authority to manage, direct, superintend, restrict, regulate, govern, or administer any of the policies or operations of the Company or exercise any power or authority to direct such Stockholder in the voting of any of the Shares, except as otherwise provided herein.

12. Termination. This Agreement shall terminate and shall have no further force or effect as of the Expiration Date. Notwithstanding the foregoing, upon termination or expiration of this Agreement, no party shall have any further obligations or liabilities under this Agreement; provided, however, nothing set forth in this Section 12 or elsewhere in this Agreement shall relieve any party from liability for any fraud or for any willful and material breach of this Agreement prior to termination hereof.

13. Further Assurances. Each Stockholder shall, from time to time, execute and deliver, or cause to be executed and delivered, such additional or further consents, documents and other instruments as the Company or Homology may reasonably request for the purpose of effectively carrying out the transactions contemplated by this Agreement and the Contemplated Transactions. [Reserved]1

14. Disclosure. Each Stockholder hereby agrees that Homology and the Company may publish and disclose in the Proxy Statement, any prospectus filed with any regulatory authority in connection with the Contemplated Transactions and any related documents filed with such regulatory authority and as otherwise required by Law,

 

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such Stockholder’s identity and ownership of Shares and the nature of such Stockholder’s commitments, arrangements and understandings under this Agreement and may further file this Agreement as an exhibit to the Proxy Statement or prospectus or in any other filing made by Homology or the Company as required by Law or the terms of the Merger Agreement, including with the SEC or other regulatory authority, relating to the Contemplated Transactions, all subject to prior review and a reasonable opportunity to comment by Stockholder’s counsel. Prior to the Closing, each Stockholder shall not, and shall use its reasonable best efforts to cause its representatives not to, directly or indirectly, make any press release, public announcement or other public communication regarding the Merger without the prior written consent of Homology and the Company, provided that the foregoing shall not limit or affect any actions taken by such Stockholder (or any affiliated officer or director of such Stockholder) that would be permitted to be taken by such Stockholder, Homology or the Company pursuant to the Merger Agreement; provided, further, that the foregoing shall not effect any actions of Stockholder the prohibition of which would be prohibited under applicable Law and shall not prohibit Stockholder or its affiliates from making any publicly-available filings required by applicable law, regulation or legal process.

15. Notice. All notices and other communications hereunder shall be in writing and shall be deemed given if delivered personally or sent by overnight courier (providing proof of delivery), by facsimile transmission (providing confirmation of transmission) or by electronic transmission (providing confirmation of transmission) to the Company or Homology, as the case may be, in accordance with Section 9.7 of the Merger Agreement and to each Stockholder at his, her or its address or email address (providing confirmation of transmission) set forth on Schedule 1 attached hereto (or at such other address for a party as shall be specified by like notice).

16. Severability. Any term or provision of this Agreement that is invalid or unenforceable in any situation in any jurisdiction shall not affect the validity or enforceability of the remaining terms and provisions of this Agreement or the validity or enforceability of the offending term or provision in any other situation or in any other jurisdiction. If a final judgment of a court of competent jurisdiction declares that any term or provision of this Agreement is invalid or unenforceable, the parties hereto agree that the court making such determination shall have the power to limit such term or provision, to delete specific words or phrases or to replace such term or provision with a term or provision that is valid and enforceable and that comes closest to expressing the intention of the invalid or unenforceable term or provision, and this Agreement shall be valid and enforceable as so modified. In the event such court does not exercise the power granted to it in the prior sentence, the parties hereto agree to replace such invalid or unenforceable term or provision with a valid and enforceable term or provision that will achieve, to the extent possible, the economic, business and other purposes of such invalid or unenforceable term or provision.

17. Assignability. This Agreement shall be binding upon, and shall be enforceable by and inure solely to the benefit of, the parties hereto and their respective successors and assigns; provided, however, that neither this Agreement nor any of a party’s rights or obligations hereunder may be assigned or delegated by such party without the prior written consent of the other parties hereto, and any attempted assignment or delegation of this Agreement or any of such rights or obligations by such party without the other party’s prior written consent shall be void and of no effect. Nothing in this Agreement, express or implied, is intended to or shall confer upon any Person (other than the parties hereto) any right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.

18. No Waivers. No waivers of any breach of this Agreement extended by the Company or Homology to such Stockholder shall be construed as a waiver of any rights or remedies of the Company or Homology, as applicable, with respect to any other stockholder of the Company who has executed an agreement substantially in the form of this Agreement with respect to Shares held or subsequently held by such stockholder or with respect to any subsequent breach of Stockholder or any other such stockholder of the Company. No waiver of any provisions hereof by any party shall be deemed a waiver of any other provisions hereof by any such party, nor shall any such waiver be deemed a continuing waiver of any provision hereof by such party.

 

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19. Applicable Law; Jurisdiction. This Agreement shall be governed by, and construed in accordance with, the Laws of the state of Delaware, regardless of the Laws that might otherwise govern under applicable principles of conflicts of Laws. In any action or Legal Proceeding between any of the parties arising out of or relating to this Agreement, each of the parties: (i) irrevocably and unconditionally consents and submits to the exclusive jurisdiction and venue of the Court of Chancery of the state of Delaware or to the extent such court does not have subject matter jurisdiction, the Superior Court of the State of Delaware or the United States District Court for the District of Delaware, (ii) agrees that all claims in respect of such action or Legal Proceeding shall be heard and determined exclusively in accordance with clause (i) of this Section 19, (iii) waives any objection to laying venue in any such action or Legal Proceeding in such courts, (iv) waives any objection that such courts are an inconvenient forum or do not have jurisdiction over any party, and (v) agrees that service of process upon such party in any such action or Legal Proceeding shall be effective if notice is given in accordance with Section 15 of this Agreement. Each party irrevocably consents to service of process inside or outside the territorial jurisdiction of the courts referred to in this Section 19 in the manner provided for notices in Section 15. Nothing in this Agreement will affect the right of any party to serve process in any other manner permitted by applicable Law.

20. Waiver of Jury Trial. The parties hereto hereby waive any right to trial by jury with respect to any action or Legal Proceeding related to or arising out of this Agreement, any document executed in connection herewith and the matters contemplated hereby and thereby.

21. No Agreement Until Executed. Irrespective of negotiations among the parties or the exchanging of drafts of this Agreement, this Agreement shall not constitute or be deemed to evidence a Contract, agreement, arrangement or understanding between the parties hereto unless and until (a) the Q32 Board has approved, for purposes of any applicable anti-takeover Laws and regulations and any applicable provision of the certificate of incorporation of the Company, the Merger Agreement and the Contemplated Transactions, (b) the Merger Agreement is executed by all parties thereto, and (c) this Agreement is executed by all parties hereto.

22. Entire Agreement; Counterparts; Exchanges by Electronic Transmission. This Agreement and the other agreements referred to in this Agreement constitute the entire agreement and supersede all prior agreements and understandings, both written and oral, among or between any of the parties with respect to the subject matter hereof and thereof. This Agreement may be executed in several counterparts, each of which shall be deemed an original and all of which shall constitute one and the same instrument. The exchange of a fully executed Agreement (in counterparts or otherwise) by all parties by facsimile or electronic transmission via “.pdf” shall be sufficient to bind the parties to the terms and conditions of this Agreement.

23. Amendment. This Agreement may not be amended, supplemented or modified, and no provisions hereof may be modified or waived, except by an instrument in writing signed on behalf of each party hereto; provided, however, that the rights or obligations of any Stockholder may be waived, amended or otherwise modified in a writing signed by Homology, the Company and such Stockholder.

24. Fees and Expenses. Except as otherwise specifically provided herein, [or in any separate agreement with the Company,]1 the Merger Agreement or any other agreement contemplated by the Merger Agreement to which a party hereto is a party, each party hereto shall bear its own expenses in connection with this Agreement and the transactions contemplated hereby.

25. Voluntary Execution of Agreement. This Agreement is executed voluntarily and without any duress or undue influence on the part or behalf of the parties. Each of the parties hereby acknowledges, represents and warrants that (i) it has read and fully understood the Merger Agreement including the provisions relating to the payment and allocation of the consideration to be paid to stockholders of the Company as well as holders of Q32 Options, this Agreement, and the implications and consequences thereof; (ii) it has been represented in the

 

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preparation, negotiation, and execution of this Agreement by legal counsel of its own choice, or it has made a voluntary and informed decision to decline to seek such counsel; and (iii) it is fully aware of the legal and binding effect of this Agreement.

26. Definition of Merger Agreement. For purposes of this Agreement, the term “Merger Agreement” may include such agreement as amended or modified as long as such amendments or modifications (a) do not (i) change the form or amount of consideration payable under the Merger Agreement, (ii) extend the Outside Date past May 16, 2024 (other than any extension provided for in Section 8.1(b) of the Merger Agreement with respect to the Registration Statement), or (iii) otherwise change the terms and conditions of the Merger, the Concurrent Financing or the other Contemplated Transaction in a manner materially adverse to such Stockholder or (b) have been agreed to in writing by such Stockholder.

27. Construction.

(a) For purposes of this Agreement, whenever the context requires: the singular number shall include the plural, and vice versa; the masculine gender shall include the feminine and neuter genders; the feminine gender shall include the masculine and neuter genders; and the neuter gender shall include masculine and feminine genders.

(b) The parties hereto agree that any rule of construction to the effect that ambiguities are to be resolved against the drafting party shall not be applied in the construction or interpretation of this Agreement.

(c) As used in this Agreement, the words “include” and “including,” and variations thereof, shall not be deemed to be terms of limitation, but rather shall be deemed to be followed by the words “without limitation.”

(d) Except as otherwise indicated, all references in this Agreement to “Sections,” and “Schedules” are intended to refer to Sections of this Agreement and Schedules to this Agreement, respectively.

(e) The underlined headings contained in this Agreement are for convenience of reference only, shall not be deemed to be a part of this Agreement and shall not be referred to in connection with the construction or interpretation of this Agreement.

[Remainder of Page has Intentionally Been Left Blank]

 

 

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EXECUTED as of the date first above written.
    [STOCKHOLDER]
    Signature:                                                        

[Signature Page to Q32 Support Agreement]


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EXECUTED as of the date first above written.

 

HOMOLOGY MEDICINES, INC.
By:  

 

Name:
Title:
Q32 BIO INC.
By:  

 

Name:
Title:

[Signature Page to Q32 Support Agreement]


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SCHEDULE 1

[Intentionally Omitted]


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Annex D

CONTINGENT VALUE RIGHTS AGREEMENT

BETWEEN

HOMOLOGY MEDICINES, INC.

and

EQUINITI TRUST COMPANY, LLC, as Rights Agent

Dated as of [*]


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TABLE OF CONTENTS

 

         Page  

ARTICLE 1 DEFINITIONS

     1  

Section 1.1

  Definitions      1  

ARTICLE 2 CONTINGENT VALUE RIGHTS

     4  

Section 2.1

  Holders of CVRs; Appointment of Rights Agent      4  

Section 2.2

  Non-transferable      4  

Section 2.3

  No Certificate; Registration; Registration of Transfer; Change of Address      4  

Section 2.4

  Payment Procedures      5  

Section 2.5

  No Voting, Dividends or Interest; No Equity or Ownership Interest      6  

Section 2.6

  Ability to Abandon CVR      7  

ARTICLE 3 THE RIGHTS AGENT

     7  

Section 3.1

  Certain Duties and Responsibilities      7  

Section 3.2

  Certain Rights of Rights Agent      7  

Section 3.3

  Resignation and Removal; Appointment of Successor      9  

Section 3.4

  Acceptance of Appointment by Successor      10  

ARTICLE 4 COVENANTS

     10  

Section 4.1

  List of Holders      10  

Section 4.2

  CVR Committee; Efforts      10  

Section 4.3

  Prohibited Actions      12  

ARTICLE 5 AMENDMENTS

     12  

Section 5.1

  Amendments Without Consent of Holders or Rights Agent      12  

Section 5.2

  Amendments with Consent of Holders      13  

Section 5.3

  Effect of Amendments      13  

ARTICLE 6 CONSOLIDATION, MERGER, SALE OR CONVEYANCE

     13  

Section 6.1

  Homology May Not Consolidate, Etc.      13  

Section 6.2

  Successor Substituted      13  

ARTICLE 7 MISCELLANEOUS

     14  

Section 7.1

  Notices to Rights Agent and to Homology      14  

Section 7.2

  Notice to Holders      14  

Section 7.3

  Entire Agreement      14  

Section 7.4

  Merger or Consolidation or Change of Name of Rights Agent      15  

Section 7.5

  Successors and Assigns      15  

Section 7.6

  Benefits of Agreement; Action by Majority of Holders      15  

Section 7.7

  Governing Law      15  

Section 7.8

  Jurisdiction      15  

Section 7.9

  WAIVER OF JURY TRIAL      16  

Section 7.10

  Severability Clause      16  

Section 7.11

  Counterparts; Effectiveness      16  

Section 7.12

  Termination      16  

Section 7.13

  Force Majeure      17  

Section 7.14

  Construction      17  

 

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FORM OF

CONTINGENT VALUE RIGHTS AGREEMENT

THIS CONTINGENT VALUE RIGHTS AGREEMENT (this “Agreement”), dated as of [*], is entered into by and between Homology Medicines, Inc., a Delaware corporation (“Homology”), and Equiniti Trust Company, LLC, a New York limited liability company (“EQ”), as initial Rights Agent (as defined herein).

PREAMBLE

WHEREAS, Homology, Kenobi Merger Sub, Inc., a Delaware corporation and wholly-owned subsidiary of Homology (“Merger Sub”), and Q32 Bio Inc., a Delaware corporation (the “Company”), have entered into an Agreement and Plan of Merger, dated as of November 16, 2023 (the “Merger Agreement”), pursuant to which Merger Sub will merge with and into the Company (the “Merger”), with the Company surviving the Merger as a wholly-owned subsidiary of Homology (the “Surviving Corporation”);

WHEREAS, in connection with the Merger Agreement, Homology has agreed to provide to the Holders (as defined herein) contingent value rights as hereinafter described;

WHEREAS, the parties have done all things necessary to make the contingent value rights, when issued pursuant to this Agreement, the valid obligations of Homology and to make this Agreement a valid and binding agreement of Homology, in accordance with its terms; and

NOW, THEREFORE, in consideration of the premises and the consummation of the transactions referred to above, it is mutually covenanted and agreed, for the proportionate benefit of all Holders, as follows:

ARTICLE 1

DEFINITIONS

Section 1.1 Definitions.

Capitalized terms used but not otherwise defined herein have the meanings ascribed thereto in the Merger Agreement. The following terms have the meanings ascribed to them as follows:

“Business Day” means any day other than a day on which banks in the State of New York are authorized or obligated to be closed.

“Closing” means the closing of the Merger.

“Closing Date” means the date on which the Closing actually takes place.

“Commercially Reasonable Efforts” means with respect to the disposition of the Legacy Assets, carrying out those obligations and tasks in a good faith and diligent manner, including the fact that, following the Merger, the Legacy Assets are not part of Homology’s go-forward business plan, taking into account all commercial and other relevant factors that Homology, exercising good faith, would normally take into account with a disposition of non-core assets, provided that, notwithstanding the foregoing, such level of efforts and resources shall not require Homology to (i) hire or retain any business development personnel or third-party financial advisors specifically for the purpose of the Legacy Asset Disposition, or (ii) initiate any bona fide sale process or other pro-active efforts to identify potential counterparties with respect to any Legacy Assets, and provided, further,

 

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that such level of efforts and resources shall be determined without taking into account the CVR Payment payable in accordance with, and subject to, the terms hereof.

“CVR” means a contingent contractual right of Holders to receive CVR Payments under this Agreement.

“CVR Payment” means the CVR Proceeds for a given payment.

“CVR Period” means the period beginning immediately following the Effective Time and ending on the tenth anniversary of the Closing Date.

“CVR Proceeds” means, upon the consummation of any Legacy Asset Disposition following the Closing Date and prior to expiration of the Disposition Period or, if applicable, the fiscal quarter during the CVR Period in which the proceeds of any Legacy Asset Disposition are received, the amount of Gross Proceeds actually received by Homology or any of its Subsidiaries upon such consummation or during the applicable fiscal quarter, less Permitted Deductions with respect to such Gross Proceeds, in each case as calculated in accordance with GAAP consistently applied.

“Disposition Period” means the period beginning on the execution date of the Merger Agreement and ending on the 18 month anniversary of the Closing Date; provided, that, for any sale, transfer, license, assignment, or other divestiture, disposition or commercialization of any Oxford Assets, the Disposition Period means the period beginning on the execution date of the Merger Agreement and ending on the 24 month anniversary of the Closing Date solely with respect to such Oxford Assets.

“Effective Time” means the time at which the Merger shall become effective at the time of the filing of the Certificate of Merger and the acceptance by the Secretary of State of the State of Delaware, or at such later time as may be specified in such Certificate of Merger with the consent of Homology and the Company.

“Expense Reserve” means $[•]1.

“Gross Proceeds” means, without duplication, all cash consideration that is paid to, or is received by, Homology or any of its Subsidiaries during the CVR Period in consideration for a Legacy Asset Disposition.

“Holder” means, at the relevant time, a Person in whose name CVRs are registered in the CVR Register.

“Majority of Holders” means, at any time, the registered Holder or Holders of more than 50% of the total number of CVRs registered at such time, as set forth on the CVR Register.

“Legacy Assets” means the assets, rights and interests held by or on behalf of Homology or any of its Subsidiaries as of the execution date of the Merger Agreement relating to Homology’s HMI-103 (Adult/Pediatric PKU), HMI-204 (MLD), Capsids and AAVHSC Platform, including any equity interests held directly or indirectly by Homology in Oxford Biomedica Solutions, LLC or its affiliates (“OXB Solutions”) pursuant to that certain Equity Securities Purchase Agreement, dated as of January 28, 2022, by and between Homology and OXB Solutions, in which Homology owns twenty percent (20%) of the fully diluted equity interests in OXB Solutions and Homology is entitled to exercise a put option to sell or transfer Homology’s equity interests in OXB Solutions set forth therein on March 10, 2025 (such interests, the “Oxford Assets”); provided that Legacy Assets shall not include any Abandoned Homology Legacy IP Rights (as defined in the Merger Agreement).

“Legacy Asset Disposition” means the sale, transfer, license, assignment or other divestiture, disposition or commercialization of any Legacy Assets (including any such sale or disposition of equity securities in any

 

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Note to Draft: In connection with execution of the CVR Agreement at Closing, to insert the dollar amount actually deducted from Net Cash to cover expenses related to maintenance and disposition of Legacy Assets during the Disposition Period, which amount shall not exceed $400,000 in the aggregate.

 

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Subsidiary that was established by Homology during the Disposition Period solely to hold any right, title or interest in or to all or any Legacy Assets) in a transaction or series of transactions, in each case entered into during the Disposition Period.

“Officer’s Certificate” means a certificate signed by the chief executive officer or the chief financial officer of Homology, in their respective official capacities.

“Permitted Deductions” means the following costs or expenses, without duplication:

 

  (i)

any applicable and non-recoverable value added, sales or similar Taxes imposed on the Gross Proceeds and payable in cash by Homology or any of its Subsidiaries and any income Taxes required to be paid in cash by Homology or any of its Subsidiaries, in each case, with respect to the taxable year in which such Gross Proceeds were received which Taxes would not have been required to be paid by Homology or its applicable Subsidiary but for its receipt of Gross Proceeds; provided, that, for purposes of calculating any income Taxes of Homology or any of its Subsidiaries for this purpose, (a) such income Taxes shall be computed after taking into account any net operating loss carryforwards or other Tax attributes (including Tax credits) of Homology or any of its Subsidiaries that are available to offset income or gain, after taking into account any limits of the usability of such attributes under applicable Law, including under Section 382 of the Code, as reasonably determined by a nationally recognized tax advisor, which Tax attributes were generated either (I) prior to the Closing Date or (II) after the Closing Date, in the case of this clause (II) if such Tax attributes relate to the Legacy Assets, and (b) for the avoidance of doubt, any item(s) of income or gain resulting or arising from such Gross Proceeds shall be treated as the first item(s) of income or gain, as applicable, in the applicable taxable year;

 

  (ii)

any documented out-of-pocket costs and expenses incurred or accrued by Homology or any of its Subsidiaries in respect of its performance of this Agreement following the Closing Date or in respect of its negotiation, execution, delivery or performance of any agreement in connection with the Legacy Assets (for clarity, including any Sale Agreement), including (i) any costs related to the prosecution, maintenance or enforcement by Homology or any of its Subsidiaries of intellectual property rights (but excluding any costs related to a breach of this Agreement by Homology, including costs incurred in litigation in respect of the same), (ii) any costs related to Liabilities of or relating to the Legacy Assets that remain with Homology following the consummation of any Legacy Asset Disposition or (iii) any documented out-of-pocket fees of the Rights Agent in connection with this Agreement;

 

  (iii)

any documented out-of-pocket costs incurred or accrued by Homology or any of its Subsidiaries in connection with the negotiation, entry into and closing of any Legacy Asset Disposition, including any brokerage fee, finder’s fee, opinion fee, success fee, transaction fee, service fee, regulatory and other filing fees, or other fee, commission or expense owed to any broker, finder, investment bank, auditor, accountant, counsel, advisor or other third party in relation thereto;

 

  (iv)

any Losses incurred and paid or payable by Homology or any of its Subsidiaries arising out of any third party claims, demands, actions or other proceedings relating to or in connection with any Legacy Assets or any Legacy Asset Disposition, including in respect of its performance of this Agreement, any Sale Agreement or any other agreement relating to any Legacy Asset Disposition and, notwithstanding anything in this Agreement to the contrary, the maximum amount that could be payable under any obligations of Homology or any of its Subsidiaries (including contingent or indemnification obligations provided for, arising out of or in connection with any Sale Agreement or any other agreement relating to any Legacy Asset Disposition); provided that any amounts deducted in respect of contingent or indemnification obligations shall be held back by Homology in a separate account for the benefit of the Holders and to the extent such amounts have not been used to pay such contingent or indemnification obligations upon the lapse in survival of the such contingent or indemnification obligations (or, if applicable, until any dispute related to such provisions is finally resolved if such resolution occurs subsequent to such lapse) prior to the end of the CVR Period, shall be paid over to the Rights Agent within five (5) Business days of such lapse; and

 

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  (v)

any liabilities borne by Homology or any of its Subsidiaries pursuant to contracts related to the Legacy Assets, including costs arising from the termination thereof (in each case only to the extent not included in the calculation of Homology Net Cash (as defined in the Merger Agreement)).

“Permitted Transfer” means a Transfer of one or more CVRs (i) upon death of a Holder by will or intestacy; (ii) by instrument to an inter vivos or testamentary trust in which the CVRs are to be passed to beneficiaries upon the death of the trustee; (iii) made pursuant to a court order of a court of competent jurisdiction (such as in connection with divorce, bankruptcy or liquidation); (iv) made by operation of law (including a consolidation or merger) or without consideration in connection with the dissolution, liquidation or termination of any corporation, limited liability company, partnership or other entity; (v) in the case of CVRs payable to a nominee, from a nominee to a beneficial owner (and, if applicable, through an intermediary) or from such nominee to another nominee for the same beneficial owner, in each case as permitted by The Depository Trust Company; (vi) to Homology or its Subsidiaries; or (vii) as provided in Section 2.6.

“Person” means any individual, partnership, joint venture, limited liability company, firm, corporation, unincorporated association or organization, trust or other entity, and shall include any successor (by merger or otherwise) of any such Person.

“Record Date” means the close of business on the last Business Day prior to the day on which the Effective Time occurs.

“Rights Agent” means the Rights Agent named in the first paragraph of this Agreement, until a successor Rights Agent shall have been appointed pursuant to Article 3 of this Agreement, and thereafter “Rights Agent” will mean such successor Rights Agent.

“Transfer” means transfer, pledge, hypothecation, encumbrance, assignment or other disposition (whether by sale, merger, consolidation, liquidation, dissolution, dividend, distribution or otherwise), the offer to make such a transfer or other disposition, and each contract, arrangement or understanding, whether or not in writing, to effect any of the foregoing.

ARTICLE 2

CONTINGENT VALUE RIGHTS

Section 2.1 Holders of CVRs; Appointment of Rights Agent.

 

(a)

The CVRs shall be issued to the holders of shares of Homology Common Stock as of the Record Date.

 

(b)

Homology hereby appoints the Rights Agent to act as rights agent for Homology in accordance with the express terms and conditions set forth in this Agreement, and the Rights Agent hereby accepts such appointment.

Section 2.2 Non-transferable.

A Holder may not at any time Transfer CVRs, other than pursuant to a Permitted Transfer. Any attempted Transfer that is not a Permitted Transfer, in whole or in part, will be void ab initio and of no effect. The CVRs will not be listed on any quotation system or traded on any securities exchange.

Section 2.3 No Certificate; Registration; Registration of Transfer; Change of Address.

 

(a)

Holders’ rights and obligations in respect of CVRs derive solely from this Agreement; CVRs will not be evidenced by a certificate or other instrument.

(b)

The Rights Agent will maintain an up-to-date register (the “CVR Register”) for the purposes of (i) identifying the Holders of CVRs, (ii) determining Holders’ entitlement to CVRs and (iii) registering the

 

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  CVRs and Permitted Transfers thereof. The CVR Register will initially show one position for The Depository Trust Company (or its nominee) representing all of the CVRs provided to the holders of shares of Homology Common Stock held as of the Record Date. Except as expressly provided herein with respect to the rights of the Rights Agent, neither Homology nor its Subsidiaries will have any responsibility or liability whatsoever to any person other than the Holders.

 

(c)

Subject to the restriction on transferability set forth in Section 2.2, every request made to Transfer CVRs must be in writing and accompanied by a written instrument of Transfer reasonably acceptable to the Rights Agent, together with the signature guarantee of a guarantor institution which is a participant in a signature guarantee program approved by the Securities Transfer Association (a “signature guarantee”) and other requested documentation in a form reasonably satisfactory to the Rights Agent, duly executed and properly completed, as applicable, by the Holder or Holders thereof, or by the duly appointed legal representative, personal representative or survivor of such Holder or Holders, setting forth in reasonable detail the circumstances relating to the Transfer. Upon receipt of such written notice, the Rights Agent will, subject to its reasonable determination in accordance with its own internal procedures that the Transfer instrument is in proper form and the Transfer is a Permitted Transfer and otherwise complies on its face with the other terms and conditions of this Agreement, register the Transfer of the applicable CVRs in the CVR Register. All Transfers of CVRs registered in the CVR Register will be the valid obligations of Homology, evidencing the same right, and entitling the transferee to the same benefits and rights under this Agreement, as those held by the transferor. Each of Homology and the Rights Agent may require payment (without duplication) of a sum sufficient to cover any stamp or other transfer Tax or governmental charge that is imposed in connection with (and would not have been imposed but for) any such registration of transfer, unless the transferee shall have established to the reasonable satisfaction of Homology or the Rights Agent, as applicable, that such Tax, if any, has been paid. No transfer of CVRs shall be valid until registered in the CVR Register and any transfer not duly registered in the CVR Register shall be void. Homology shall not be responsible for any costs and expenses related to any transfer or assignment of the CVRs (including the cost of any transfer tax).

 

(d)

A Holder may make a written request to the Rights Agent to change such Holder’s address of record in the CVR Register. Such written request must be duly executed by such Holder. Upon receipt of such written notice, the Rights Agent shall promptly record the change of address in the CVR Register.

Section 2.4 Payment Procedures.

 

(a)

As promptly as practicable (and, in any event, within twenty (20) days) after the consummation of any Legacy Asset Dispositions and, in any event, not later than the date that is forty-five (45) days following the end of each fiscal quarter of Homology following the Closing in which CVR Proceeds are actually received by Homology or any of its Subsidiaries, Homology shall (i) deliver to the Rights Agent, an Officer’s Certificate certifying the aggregate amount of (A) the CVR Proceeds (if any) actually received by Homology or its Subsidiaries during such fiscal quarter (or, in the case of the first delivery of such an Officer’s Certificate hereunder, all CVR Proceeds actually received through the end of such fiscal quarter); (B) the Permitted Deductions reflected in such CVR Proceeds; and (C) the CVR Payment payable to Holders, if any, in respect of such CVR Proceeds, and (ii) deliver to the Rights Agent, or as the Rights Agent directs, the CVR Payment (if any) by wire transfer of immediately available funds to an account designated in writing by the Rights Agent. Upon receipt of the wire transfer referred to in the foregoing sentence, the Rights Agent shall promptly (and in any event, within ten (10) Business Days) pay, by check mailed, first-class postage prepaid, to the address of each Holder set forth in the CVR Register at such time or by other method of delivery as specified by the applicable Holder in writing to the Rights Agent, an amount equal to the product determined by multiplying (i) the quotient determined by dividing (A) the applicable CVR Payment by (B) the total number of CVRs registered in the CVR Register at such time, by (ii) the number of CVRs registered to such Holder in the CVR Register at such time. For the avoidance of doubt Homology shall have no further liability in respect of the relevant CVR Payment upon delivery of such CVR Payment in accordance with this Section 2.4(a) and the satisfaction of each of Homology’s obligations set forth in this Section 2.4(a).

 

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(b)

Except to the extent otherwise required pursuant to a change in applicable Law after the date hereof, the parties hereto agree to treat the issuance of the CVRs as not constituting a current distribution and all CVR Payments for U.S. federal (and applicable state and local) income Tax purposes as distributions of money governed by Section 301 of the U.S. Internal Revenue Code of 1986, as amended (the “Code”), which will constitute a dividend to the extent payable out of Homology and its Subsidiaries’ current and accumulated “earnings and profits” (pursuant to Section 316 of the Code) in the taxable year in which any such CVR Payment is made. The parties hereto will not take any position to the contrary on any Tax Return or for other Tax purposes except as required by a change in applicable Law after the date hereof.

 

(c)

Homology and the Rights Agent will be entitled to deduct and withhold, or cause to be deducted and withheld, from any CVR Payment otherwise payable pursuant to this Agreement, such amounts as it is required to deduct and withhold with respect to the making of such payment under any provision of applicable Law relating to Taxes. To the extent that amounts are so deducted and withheld and paid over to the appropriate Governmental Authority, such deducted and withheld amounts will be treated for all purposes of this Agreement as having been paid to the Holder in respect of which such deduction and withholding was made. Prior to making any such deductions or withholdings or causing any such deductions or withholdings to be made with respect to any Holder, the Rights Agent will, to the extent reasonably practicable, provide notice to the Holder of such potential Tax deduction or withholding and a reasonable opportunity for the Holder to provide any necessary Tax forms in order to avoid or reduce such withholding amounts; provided that the time period for payment of a CVR Payment by the Rights Agent set forth in Section 2.4(a) will be extended by a period equal to any delay caused by the Holder providing such forms; provided, further, that in no event shall such period be extended for more than ten (10) Business Days, unless otherwise requested by the Holder for the purpose of delivering such forms and agreed to by the Rights Agent.

 

(d)

Any portion of a CVR Payment that remains undistributed to the Holders six (6) months after the applicable fiscal quarter end (including by means of uncashed checks or invalid addresses on the CVR Register) will be delivered by the Rights Agent to Homology or a person nominated in writing by Homology (with written notice thereof from Homology to the Rights Agent), and any Holder will thereafter look only to Homology for payment of such CVR Payment (which shall be without interest).

 

(e)

Neither Homology nor the Rights Agent will be liable to any Person in respect of any CVR Payment amount delivered to a public official pursuant to any applicable abandoned property, escheat or similar legal requirement under applicable law. In addition to and not in limitation of any other indemnity obligation herein, Homology agrees to indemnify and hold harmless the Rights Agent with respect to any liability, penalty, cost or expense the Rights Agent may incur or be subject to in connection with transferring such property to Homology or a public official.

Section 2.5 No Voting, Dividends or Interest; No Equity or Ownership Interest.

 

(a)

CVRs will not have any voting or dividend rights, and interest will not accrue on any amounts payable in respect of CVRs.

 

(b)

CVRs will not represent any equity or ownership interest in Homology or any of its Subsidiaries or in the Surviving Corporation. The sole right of the Holders to receive property hereunder is the right to receive CVR Payments, if any, in accordance with the terms hereof. It is hereby acknowledged and agreed that a CVR shall not constitute a security of Homology or any of its Subsidiaries or of the Surviving Corporation.

 

(c)

It is hereby acknowledged and agreed that the CVRs and the possibility of any payment hereunder with respect thereto are highly speculative and subject to numerous factors outside of Homology’s control, and there is no assurance that Holders will receive any payments under this Agreement or in connection with the CVRs. Each Holder acknowledges that it is highly possible that there will not be any Gross Proceeds that may be the subject of a CVR Payment Amount. It is further acknowledged and agreed that neither Homology nor its Subsidiaries owe, by virtue of their obligations under this Agreement, a fiduciary duty or any implied duties to the Holders and the parties hereto intend solely the express provisions of this

 

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  Agreement to govern their contractual relationship with respect to the CVRs. It is acknowledged and agreed that this Section 2.5(c) is an essential and material term of this Agreement.

Section 2.6 Ability to Abandon CVR.

A Holder may at any time, at such Holder’s option, abandon all of such Holder’s remaining rights represented by CVRs by transferring such CVR to Homology or a person nominated in writing by Homology (with written notice thereof from Homology to the Rights Agent) without consideration or compensation therefor, and such rights will be cancelled, with the Rights Agent being promptly notified in writing by Homology of such transfer and cancellation. Nothing in this Agreement is intended to prohibit Homology or its Subsidiaries from offering to acquire or acquiring CVRs, in private transactions or otherwise, for consideration in its sole discretion.

ARTICLE 3

THE RIGHTS AGENT

Section 3.1 Certain Duties and Responsibilities.

 

(a)

The Rights Agent will not have any liability for any actions taken or not taken in connection with this Agreement, except to the extent such liability arises as a result of the willful misconduct, bad faith or gross negligence of the Rights Agent (in each case as determined by a final non-appealable judgment of court of competent jurisdiction). Notwithstanding anything in this Agreement to the contrary, any liability of the Rights Agent under this Agreement will be limited to the amount of annual fees paid by Homology to the Rights Agent during the twelve (12) months immediately preceding the event for which recovery from the Rights Agent is being sought, except in the case of the willful misconduct, bad faith or fraud of the Rights Agent (in each case as determined by a final non-appealable judgment of court of competent jurisdiction). Anything to the contrary notwithstanding, in no event will the Rights Agent be liable for special, punitive, indirect, incidental or consequential loss or damages of any kind whatsoever (including, without limitation, lost profits), even if the Rights Agent has been advised of the likelihood of such loss or damages, and regardless of the form of action.

 

(b)

The Rights Agent shall not have any duty or responsibility in the case of the receipt of any written demand from any Holder with respect to any action or default by any person or entity, including, without limiting the generality of the foregoing, any duty or responsibility to initiate or attempt to initiate any proceedings at law or otherwise or to make any demand upon Homology or the Company.

Section 3.2 Certain Rights of Rights Agent.

 

(a)

The Rights Agent undertakes to perform such duties and only such duties as are specifically set forth in this Agreement, and no implied covenants or obligations will be read into this Agreement against the Rights Agent.

 

(b)

The Rights Agent may rely and will be protected by Homology in acting or refraining from acting upon any resolution, certificate, statement, instrument, opinion, report, notice, request, direction, consent, order or other paper or document reasonably believed by it in the absence of bad faith to be genuine and to have been signed or presented by or on behalf of Homology.

 

(c)

The Rights Agent may engage and consult with counsel of its selection, and the advice or opinion of such counsel will, in the absence of bad faith, gross negligence or willful misconduct (in each case, as determined by a final, non-appealable judgment of a court of competent jurisdiction) on the part of the Rights Agent, be full and complete authorization and protection in respect of any action taken or not taken by the Rights Agent in reliance thereon.

 

(d)

Any permissive rights of the Rights Agent hereunder will not be construed as a duty.

 

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(e)

The Rights Agent will not be required to give any note or surety in respect of the execution of its powers or otherwise under this Agreement.

 

(f)

Homology agrees to indemnify the Rights Agent for, and to hold the Rights Agent harmless from and against, any loss, liability, damage, judgment, fine, penalty, cost or expense (each, a “Loss”) suffered or incurred by the Rights Agent and arising out of or in connection with the Rights Agent’s performance of its obligations under this Agreement, including the reasonable and documented costs and expenses of defending the Rights Agent against any claims, charges, demands, actions or suits arising out of or in connection in connection with the execution, acceptance, administration, exercise and performance of its duties under this Agreement, including the costs and expenses of defending against any claim of liability arising therefrom, directly or indirectly, or enforcing its rights hereunder, except to the extent such Loss has been determined by a final non-appealable decision of a court of competent jurisdiction to have resulted from the Rights Agent’s gross negligence, bad faith or willful misconduct (in each case, as determined by a final, non-appealable judgment of a court of competent jurisdiction).

 

(g)

In addition to the indemnification provided under Section 3.2(e), Homology agrees (i) to pay the fees of the Rights Agent in connection with the Rights Agent’s performance of its obligations hereunder, as agreed upon in writing by the Rights Agent and Homology on or prior to the date of this Agreement, and (ii) to reimburse the Rights Agent for all reasonable and documented out-of-pocket expenses and other disbursements incurred in the preparation, delivery, negotiation, amendment, administration and execution of this Agreement and the exercise and performance of its duties hereunder, including all taxes (other than income, receipt, franchise or similar taxes) and governmental charges, incurred by the Rights Agent in the performance of its obligations under this Agreement, except that Homology will have no obligation to pay the fees of the Rights Agent or reimburse the Rights Agent for the fees of counsel in connection with any lawsuit initiated by the Rights Agent on behalf of itself or the Holders, except in the case of any suit enforcing the provisions of Section 2.4(a), Section 2.4(b) or Section 3.2(e), if Homology is found by a court of competent jurisdiction to be liable to the Rights Agent or the Holders, as applicable in such suit.

 

(h)

No provision of this Agreement shall require the Rights Agent to expend or risk its own funds or otherwise incur any financial liability in the performance of any of its duties hereunder or in the exercise of any of its rights or powers if it believes that repayment of such funds or adequate indemnification against such risk or liability is not reasonably assured to it.

 

(i)

The Rights Agent will not be deemed to have knowledge of any event of which it was supposed to receive notice hereunder but has not received written notice of such event, and the Rights Agent will not incur any liability for failing to take action in connection therewith, in each case, unless and until it has received such notice in writing.

 

(j)

The Rights Agent may execute and exercise any of the rights or powers hereby vested in it or perform any duty hereunder either itself or by or through its attorney or agents and the Rights Agent shall not be answerable or accountable for any act, default, neglect or misconduct of any such attorney or agents or for any loss to Homology or the Company resulting from any such act, default, neglect or misconduct, absent gross negligence, bad faith or willful misconduct (each as determined by a final non-appealable judgment of a court of competent jurisdiction) in the selection and continued employment thereof.

 

(k)

Homology shall perform, acknowledge and deliver or cause to be performed, acknowledged and delivered all such further and other acts, documents, instruments and assurances as may be reasonably required by the Rights Agent for the carrying out or performing by the Rights Agent of the provisions of this Agreement.

 

(l)

The Rights Agent shall not be liable for or by reason of any of the statements of fact or recitals contained in this Agreement (except its countersignature thereof) or be required to verify the same, and all such statements and recitals are and shall be deemed to have been made by Homology only.

 

(m)

The Rights Agent shall act hereunder solely as agent for Homology and shall not assume any obligations or relationship of agency or trust with any of the owners or holders of the CVRs. The Rights Agent shall not have any duty or responsibility in the case of the receipt of any written demand from any Holders with

 

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  respect to any action or default by Homology, including, without limiting the generality of the foregoing, any duty or responsibility to initiate or attempt to initiate any proceedings at law or otherwise or to make any demand upon Homology.

 

(n)

The Rights Agent may rely on and be fully authorized and protected in acting or failing to act upon (i) any guaranty of signature by an “eligible guarantor institution” that is a member or participant in the Securities Transfer Agents Medallion Program or other comparable “signature guarantee program” or insurance program in addition to, or in substitution for, the foregoing; or (ii) any law, act, regulation or any interpretation of the same even though such law, act, or regulation may thereafter have been altered, changed, amended or repealed.

 

(o)

The Rights Agent shall not be liable or responsible for any failure of Homology to comply with any of its obligations relating to any registration statement filed with the Securities and Exchange Commission or this Agreement, including without limitation obligations under applicable Law.

 

(p)

Whenever the Rights Agent deems it desirable that a matter be proved or established prior to taking or omitting any action hereunder, the Rights Agent may (i) rely upon an Officer’s Certificate and (ii) incur no liability and be held harmless by the Company for or in respect of any action taken or omitted to be taken by it under the provisions of this Agreement in reliance upon such Officer’s Certificate.

 

(q)

All funds received by EQ under this Agreement that are to be distributed or applied by EQ in the performance of services hereunder (the “Funds”) shall be held by EQ as agent for Homology and deposited in one or more bank accounts to be maintained by EQ in its name as agent for Homology. Until paid pursuant to the terms of this Agreement, EQ will hold the Funds through such accounts in: deposit accounts of commercial banks with Tier 1 capital exceeding $1 billion or with an average rating above investment grade by S&P (LT Local Issuer Credit Rating), Moody’s (Long Term Rating) and Fitch Ratings, Inc. (LT Issuer Default Rating) (each as reported by Bloomberg Finance L.P.). EQ shall have no responsibility or liability for any diminution of the Funds that may result from any deposit made by EQ in accordance with this paragraph, including any losses resulting from a default by any bank, financial institution or other third party. EQ may from time to time receive interest, dividends or other earnings in connection with such deposits. EQ shall not be obligated to pay such interest, dividends or earnings to Homology, any holder or any other party.

 

(r)

The obligations of Homology and the rights of the Rights Agent under this Section 3.2, Section 3.1 and Section 2.4 shall survive the expiration of the CVRs and the termination of this Agreement and the resignation, replacement or removal of the Rights Agent.

Section 3.3 Resignation and Removal; Appointment of Successor.

 

(a)

The Rights Agent may resign at any time by written notice to Homology. Any such resignation notice shall specify the date on which such resignation will take effect (which shall be at least thirty (30) days following the date that such resignation notice is delivered), and such resignation will be effective on the earlier of (i) the date so specified and (ii) the appointment of a successor Rights Agent.

 

(b)

Homology will have the right to remove the Rights Agent at any time by written notice to the Rights Agent, specifying the date on which such removal will take effect. Such notice will be given at least thirty (30) days prior to the date so specified (or, if earlier, the appointment of the successor Rights Agent).

 

(c)

If the Rights Agent resigns, is removed or becomes incapable of acting, Homology will promptly appoint a qualified successor Rights Agent. Notwithstanding the foregoing, if Homology fails to make such appointment within a period of thirty (30) days after giving notice of such removal or after it has been notified in writing of such resignation or incapacity by the resigning or incapacitated Rights Agent, then the incumbent Rights Agent may apply to any court of competent jurisdiction for the appointment of a new Rights Agent. The successor Rights Agent so appointed will, upon its acceptance of such appointment in accordance with this Section 3.3(c) and Section 3.4, become the Rights Agent for all purposes hereunder.

 

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(d)

Homology will give notice to the Holders of each resignation or removal of the Rights Agent and each appointment of a successor Rights Agent in accordance with Section 7.2. Each notice will include the name and address of the successor Rights Agent. If Homology fails to send such notice within ten (10) Business Days after acceptance of appointment by a successor Rights Agent, the successor Rights Agent will cause the notice to be mailed at the expense of Homology.

 

(e)

Notwithstanding anything to the contrary in this Section 3.3, unless consented to in writing by the Majority of Holders, Homology will not appoint as a successor Rights Agent any Person that is not a stock transfer agent of national reputation or the corporate trust department of a commercial bank.

 

(f)

The Rights Agent will reasonably cooperate with Homology and any successor Rights Agent in connection with the transition of the duties and responsibilities of the Rights Agent to the successor Rights Agent, including the transfer of all relevant data, including the CVR Register, to the successor Rights Agent, but such predecessor Rights Agent shall not be required to make any additional expenditure or assume any additional liability in connection with the foregoing.

Section 3.4 Acceptance of Appointment by Successor.

Every successor Rights Agent appointed hereunder will, at or prior to such appointment, execute, acknowledge and deliver to Homology and to the resigning or removed Rights Agent an instrument accepting such appointment and a counterpart of this Agreement, and such successor Rights Agent, without any further act, deed or conveyance, will become vested with all the rights, powers, trusts and duties of the Rights Agent; provided that upon the request of Homology or the successor Rights Agent, such resigning or removed Rights Agent will execute and deliver an instrument transferring to such successor Rights Agent all the rights, powers and trusts of such resigning or removed Rights Agent.

ARTICLE 4

COVENANTS

Section 4.1 List of Holders.

Homology will furnish or cause to be furnished to the Rights Agent, in such form as Homology receives from Homology’s transfer agent (or other agent performing similar services for Homology), the names and addresses of the Holders within fifteen (15) Business Days following the Closing Date.

Section 4.2 CVR Committee; Efforts.

 

(a)

The Homology Board has delegated, to a special committee of the Homology Board (the “Special Committee”) comprised of four (4) directors of the Homology Board (the “Initial Special Committee Members”), the primary responsibility, authority and discretion during the Disposition Period with respect to (i) managing the Legacy Assets, (ii) negotiating any Legacy Asset Disposition during the Disposition Period; provided that the Special Committee may not cause the Company to incur costs, expenses or obligations in excess of the Expense Reserve without the prior consent of the Homology Board. The Special Committee shall also be empowered with the authority to authorize and direct any officer of Homology to negotiate, execute and deliver a definitive written agreement with respect to a Legacy Asset Disposition in a form approved by the Special Committee and consistent with this Agreement and the Merger Agreement (a “Sale Agreement”) in the name and on behalf of Homology; provided, however, that no Sale Agreement shall be entered into without the prior review and approval of the Homology Board (such approval not to be unreasonably withheld, conditioned or delayed). In the event (A) any Initial Special Committee Member no longer serves on the Special Committee during the Disposition Period, such vacancy on the Special Committee shall be filled with another director of the Homology Board, and (B) any Initial Special Committee Member who was designated by Homology no longer serves on the Special Committee during

 

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  the Disposition Period, such vacancy on the Special Committee shall be filled with a then-existing member of the Homology Board selected by the member of the post-Closing Homology Board designated by Homology. In each case of (A)-(B) above, the post-Closing Homology Board agrees to install the applicable replacement on the Special Committee.

 

(b)

The delegation of responsibility and authority to the Special Committee set forth in Section 4.2(a) shall not be revoked or modified at any time during the Disposition Period; provided, that the Special Committee shall automatically dissolve upon expiration of the Disposition Period and shall have no further responsibility or authority thereafter. The Special Committee and Homology Board shall not have any liability to the Holders for any actions taken or not taken in accordance with this Agreement in respect of the matters expressly contemplated hereby. No provision of this Agreement shall require the Special Committee or any members thereof to expend or risk its, his or her own funds or otherwise incur any financial liability in the performance of any duties hereunder or in the exercise of any rights or powers hereunder.

 

(c)

The Holders shall be intended third-party beneficiaries of the provisions of this Agreement; provided, that under no circumstances shall the rights of Holders as third-party beneficiaries pursuant to this Article 4 be enforceable by such Holders or any other Person acting for or on their behalf other than the Special Committee (or the Homology Board if the Special Committee no longer exists). The Special Committee (or the Homology Board if the Special Committee no longer exists) has the sole power and authority to act on behalf of the Holders in enforcing any of their rights hereunder.

 

(d)

During the six (6) months immediately following the Closing, Homology will, and will cause its Subsidiaries to, use Commercially Reasonable Efforts to effect Legacy Asset Dispositions with respect to the then-existing Legacy Assets (i) pursuant to a letter of intent for such Legacy Asset Disposition that was executed prior to the Closing Date, and (ii) to a third party that has delivered a bona fide indication of interest to Homology subsequent to the Closing Date, provided that such obligation will not apply to the Oxford Assets. Homology shall use Commercially Reasonable Efforts to exercise the put option on the Oxford Assets contemplated in Section 9.4 of the Limited Liability Company Agreement dated as of March 10, 2022 of OXB Solutions promptly after such put option becomes exercisable on March 10, 2025. During the Disposition Period, if and to the extent the Special Committee recommends, and the Homology Board authorizes and directs, the execution and delivery of any Sale Agreement, Homology will, and will cause its Subsidiaries to, use commercially reasonable efforts to (i) execute and deliver the Sale Agreement, and (ii) effectuate the Legacy Asset Disposition pursuant to such Sale Agreement in accordance with its terms. Notwithstanding anything in this Agreement to the contrary, unless approved by the Special Committee, Homology shall have no obligation whatsoever to enter into any Sale Agreement or other agreement in connection with a Legacy Asset Disposition that imposes on Homology or requires Homology to retain or assume, any material obligations or liabilities, monetary or otherwise, following the consummation of such transaction.

 

(e)

Except as expressly set forth in Article 3, Section 4.2(a), Section 4.2(b) or Section 4.2(d), none of Homology or any of its Subsidiaries shall have any obligation or liability whatsoever to any Person relating to or in connection with any action, or failure to act, with respect to any Legacy Asset Disposition.

 

(f)

Subject to the foregoing clause (d) and the other contractual obligations of Homology expressly set forth in this Agreement, (i) the Holders acknowledge that Homology has a fiduciary obligation to operate its business in the best interests of its stockholders, and any potential obligation to pay CVR Proceeds will not create any express or implied obligation to operate its business in any particular manner in order to maximize such CVR Proceeds, (ii) except as expressly set forth in this Agreement, the Holders are not relying on any representation of Homology or any other Person with regard to any Legacy Asset Disposition or other action involving the Legacy Assets following the Closing, and neither Homology nor any other Person has provided, or can provide, any assurance to the Holders that any CVR Proceeds will in fact be earned and paid, and (iii) none of Homology or any of its Subsidiaries, officers or directors shall have any obligation or liability whatsoever to any Person relating to or in connection with any action, or failure to act, with respect to any Legacy Asset Disposition.

 

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(g)

Following the Disposition Period, Homology shall be permitted to take any action in respect of the Legacy Assets in order to satisfy any Liabilities of or arising from the Legacy Assets, including any wind-down or termination Liabilities. For clarity, following the CVR Period and following the Disposition Period without a Legacy Asset Disposition, Homology may take any action in respect of the Legacy Assets in its sole and absolute discretion.

Section 4.3 Prohibited Actions.

Unless approved by the Special Committee (or the Homology Board if the Special Committee no longer exists), Homology shall not grant any lien, security interest, pledge or similar interest in any Legacy Assets (other than liens or security interests generally granted with respect to all assets of Homology, and not specific to the Legacy Assets, and which do not prohibit the ability of Homology to complete a Legacy Asset Disposition and, in connection therewith, to deliver title to the Legacy Assets to the purchaser thereof, free and clear of such liens and security interests) or any CVR Proceeds.

ARTICLE 5

AMENDMENTS

Section 5.1 Amendments Without Consent of Holders or Rights Agent.

 

(a)

Homology, at any time and from time to time, may (without the consent of any Person, other than the Rights Agent, which such consent not to be unreasonably withheld, conditioned, or delayed) enter into one or more amendments to this Agreement for any of the following purposes, without the consent of any of the Holders or the Rights Agent:

 

  (i)

to evidence the appointment of another Person as a successor Rights Agent and the assumption by any successor Rights Agent of the covenants and obligations of the Rights Agent herein in accordance with the provisions hereof;

 

  (ii)

subject to Section 6.1, to evidence the succession of another person to Homology and the assumption of any such successor of the covenants of Homology outlined herein in a transaction contemplated by Section 6.1;

 

  (iii)

to add to the covenants of Homology such further covenants, restrictions, conditions or provisions for the protection and benefit of the Holders; provided that in each case, such provisions shall not adversely affect the interests of the Holders;

 

  (iv)

to cure any ambiguity, to correct or supplement any provision in this Agreement that may be defective or inconsistent with any other provision in this Agreement, or to make any other provisions with respect to matters or questions arising under this Agreement; provided that in each case, such provisions shall not adversely affect the interests of the Holders;

 

  (v)

as may be necessary or appropriate to ensure that CVRs are not subject to registration under the U.S. Securities Act of 1933, as amended, or the U.S. Securities Exchange Act of 1934, as amended and the rules and regulations made thereunder, or any applicable state securities or “blue sky” laws;

 

  (vi)

as may be necessary or appropriate to ensure that Homology is not required to produce a prospectus or an admission document in order to comply with applicable Law;

 

  (vii)

to cancel CVRs (i) in the event that any Holder has abandoned its rights in accordance with Section 2.6, or (ii) following a transfer of such CVRs to Homology or its Subsidiaries in accordance with Section 2.2 or Section 2.3;

 

  (viii)

as may be necessary or appropriate to ensure that Homology complies with applicable Law; or

 

  (ix)

to effect any other amendment to this Agreement that would provide any additional rights or benefits to the Holders or that does not adversely affect the legal rights under this Agreement of any such Holder.

 

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(b)

Promptly after the execution by Homology of any amendment pursuant to this Section 5.1, Homology will (or will cause the Rights Agent to) notify the Holders in general terms of the substance of such amendment in accordance with Section 7.2.

Section 5.2 Amendments with Consent of Holders.

 

(a)

In addition to any amendments to this Agreement that may be made by Homology without the consent of any Holder or the Rights Agent pursuant to Section 5.1, with the consent of the Majority of Holders, Homology and the Rights Agent may enter into one or more amendments to this Agreement for the purpose of adding, eliminating or amending any provisions of this Agreement, even if such addition, elimination or amendment is adverse to the interests of the Holders.

 

(b)

Promptly after the execution by Homology and the Rights Agent of any amendment pursuant to the provisions of this Section 5.2, Homology will (or will cause the Rights Agent to) notify the Holders in general terms of the substance of such amendment in accordance with Section 7.2.

Section 5.3 Effect of Amendments.

Upon the execution of any amendment under this Article 5, this Agreement will be modified in accordance therewith, such amendment will form a part of this Agreement for all purposes and every Holder will be bound thereby. Upon the delivery of a certificate from an appropriate officer of Homology which states that the proposed supplement or amendment is in compliance with the terms of this Article 5, the Rights Agent shall execute such supplement or amendment. Notwithstanding anything in this Agreement to the contrary, the Rights Agent shall not be required to execute any supplement or amendment to this Agreement that it has determined would adversely affect its own rights, duties, obligations or immunities under this Agreement. No supplement or amendment to this Agreement shall be effective unless duly executed by the Rights Agent.

ARTICLE 6

CONSOLIDATION, MERGER, SALE OR CONVEYANCE

Section 6.1 Homology May Not Consolidate, Etc.

During the CVR Period, Homology shall not consolidate with or merge into any other Person or convey, transfer or lease all or substantially all of its properties and assets to any Person, unless:

 

(a)

the Person formed by such consolidation or into which Homology is merged or the Person that acquires by conveyance or transfer, or that leases, all or substantially all of the properties and assets of Homology (the “Surviving Person”) shall expressly assume Homology’s obligations under this Agreement, including payment of amounts on all CVRs in accordance with the applicable terms; and

 

(b)

Homology has delivered to the Rights Agent an Officer’s Certificate, stating that such consolidation, merger, conveyance, transfer or lease complies with this Article 6.

Section 6.2 Successor Substituted.

Upon any consolidation of or merger by Homology with or into any other Person, or any conveyance, transfer or lease of the properties and assets substantially as an entirety to any Person in accordance with Section 6.1, the Surviving Person shall succeed to, and be substituted for, and may exercise every right and power of, and shall assume all of the obligations of Homology under this Agreement with the same effect as if the Surviving Person had been named as Homology herein.

 

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ARTICLE 7

MISCELLANEOUS

Section 7.1 Notices to Rights Agent and to Homology.

All notices, requests and other communications (each, a “Notice”) to any party hereunder shall be in writing. Such Notice shall be deemed given (a) on the date of delivery, if delivered in person, by Fedex or other internationally recognized overnight courier service or, (except with respect to any Person other than the Rights Agent), by e-mail (upon confirmation of receipt) prior to 5:00 p.m. in the time zone of the receiving party or on the next Business Day, if delivered after 5:00 p.m. in the time zone of the receiving party or (b) on the first Business Day following the date of dispatch, if delivered by FedEx or by other internationally recognized overnight courier service (upon proof of delivery), addressed as follows:

if to the Rights Agent, to:

Equiniti Trust Company, LLC

6201 15th Avenue

Brooklyn, NY 11219

if to Homology, to:

Homology Medicines, Inc.

One Patriots Park

Bedford, MA 01730

Attention: Jodie Morrison

Email: [***]

with a copy, which shall not constitute notice, to:

Goodwin Procter LLP

100 Northern Avenue

Boston, Massachusetts 02210

Attention: John T. Haggerty; Jacqueline Mercier; Tevia K. Pollard

Email: [***]

or to such other address or facsimile number as such party may hereafter specify for the purpose by notice to the other parties hereto.

Section 7.2 Notice to Holders.

All Notices required to be given to the Holders will be given (unless otherwise herein expressly provided) in writing and mailed, first-class postage prepaid, to each Holder at such Holder’s address as set forth in the CVR Register, not later than the latest date, and not earlier than the earliest date, prescribed for the sending of such Notice, if any, and will be deemed given on the date of mailing. In any case where notice to the Holders is given by mail, neither the failure to mail such Notice, nor any defect in any Notice so mailed, to any particular Holder will affect the sufficiency of such Notice with respect to other Holders.

Section 7.3 Entire Agreement.

As between Homology and the Rights Agent, this Agreement constitutes the entire agreement between the parties with respect to the subject matter of this Agreement, notwithstanding the reference to any other agreement herein, and supersedes all prior agreements and understandings, both written and oral, among or between any of the parties with respect to the subject matter of this Agreement.

 

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Section 7.4 Merger or Consolidation or Change of Name of Rights Agent.

Any Person into which the Rights Agent or any successor Rights Agent may be merged or with which it may be consolidated, or Person resulting from any merger or consolidation to which the Rights Agent or any successor Rights Agent shall be a party, or any Person succeeding to the stock transfer or other shareholder services business of the Rights Agent or any successor Rights Agent, shall be the successor to the Rights Agent under this Agreement without the execution or filing of any paper or any further act on the part of any of the parties hereto, provided that such Person would be eligible for appointment as a successor Rights Agent under the provisions of Section 3.3. The purchase of all or substantially all of the Rights Agent’s assets employed in the performance of transfer agent activities shall be deemed a merger or consolidation for purposes of this Section 7.4.

Section 7.5 Successors and Assigns.

This Agreement will be binding upon, and will be enforceable by and inure solely to the benefit of, the Holders, Homology and the Rights Agent and their respective successors and assigns. Except for assignments pursuant to Section 7.4, the Rights Agent may not assign this Agreement without Homology’s prior written consent. Subject to Section 5.1(a)(ii) and Article 6 hereof, Homology may assign, in its sole discretion and without the consent of any other party, any or all of its rights, interests and obligations hereunder to one or more of its Affiliates or to any Person with whom Homology is merged or consolidated, or any entity resulting from any merger or consolidation to which Homology shall be a party (each, an “Assignee”); provided, however, that in connection with any assignment to an Assignee, Homology shall agree to remain liable for the performance by Homology of its obligations hereunder (to the extent Homology exists following such assignment). Homology or an Assignee may not otherwise assign this Agreement without the prior consent of the Majority of Holders. Any attempted assignment of this Agreement in violation of this Section 7.5 will be void ab initio and of no effect.

Section 7.6 Benefits of Agreement; Action by Majority of Holders.

Nothing in this Agreement, express or implied, will give to any Person (other than Homology, the Rights Agent, the Holders and their respective permitted successors and assigns hereunder) any benefit or any legal or equitable right, remedy or claim under this Agreement or under any covenant or provision herein contained, all such covenants and provisions being for the sole benefit of Homology, the Rights Agent, the Holders and their permitted successors and assigns. The Holders will have no rights hereunder except as are expressly set forth herein. Except for the rights of the Rights Agent set forth herein, the Majority of Holders will have the sole right, on behalf of all Holders, by virtue of or under any provision of this Agreement, to institute any action or proceeding at law or in equity with respect to this Agreement, and no individual Holder or other group of Holders will be entitled to exercise such rights.

Section 7.7 Governing Law.

This Agreement and the CVRs will be governed by, and construed in accordance with, the laws of the State of Delaware without regard to the conflicts of law rules of such state.

Section 7.8 Jurisdiction.

In any action or proceeding between any of the parties hereto arising out of or relating to this Agreement or any of the transactions contemplated hereby, each of the parties hereto: (a) irrevocably and unconditionally consents and submits to the exclusive jurisdiction and venue of the Chancery Court of the State of Delaware, County of New Castle, or, if under applicable Law exclusive jurisdiction is vested in the Federal courts, the United States District Court for the District of Delaware (and appellate courts thereof); (b) agrees that all claims in respect of such action or proceeding shall be heard and determined exclusively in accordance with clause (a) of this Section 7.8; (c) waives any objection to laying venue in any such action or proceeding in such courts;

 

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(d) waives any objection that such courts are an inconvenient forum or do not have jurisdiction over any Party; and (e) agrees that service of process upon such Party in any such action or proceeding shall be effective if notice is given in accordance with Section 7.1 or Section 7.2 of this Agreement.

Section 7.9 WAIVER OF JURY TRIAL.

EACH OF THE PARTIES HERETO (AND BY ACCEPTING THE CVR’ S, THE HOLDERS) HEREBY IRREVOCABLY WAIVES ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF OR RELATED TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY. EACH PARTY CERTIFIES AND ACKNOWLEDGES THAT (I) NO REPRESENTATIVE, AGENT OR ATTORNEY OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF LITIGATION, SEEK TO ENFORCE THE FOREGOING WAIVER, (II) EACH PARTY UNDERSTANDS AND HAS CONSIDERED THE IMPLICATION OF THIS WAIVER, (III) EACH PARTY MAKES THIS WAIVER VOLUNTARILY, AND (IV) EACH PARTY HAS BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION 7.9.

Section 7.10 Severability Clause.

In the event that any provision of this Agreement, or the application of any such provision to any Person or set of circumstances, is for any reason determined to be invalid, unlawful, void or unenforceable to any extent, the remainder of this Agreement, and the application of such provision to Persons or circumstances other than those as to which it is determined to be invalid, unlawful, void or unenforceable, will not be impaired or otherwise affected and will continue to be valid and enforceable to the fullest extent permitted by applicable Law. Upon such a determination, the parties hereto will negotiate in good faith to modify this Agreement so as to effect the original intent of the parties as closely as possible in a mutually acceptable manner in order that the transactions contemplated hereby be consummated as originally contemplated to the fullest extent possible; provided, however, that if an excluded provision shall affect the rights, immunities, liabilities, duties or obligations of the Rights Agent, the Rights Agent shall be entitled to resign immediately upon written notice to Homology.

Section 7.11 Counterparts; Effectiveness.

This Agreement may be signed in any number of counterparts, each of which will be deemed an original, with the same effect as if the signatures thereto and hereto were upon the same instrument. This Agreement or any counterpart may be executed and delivered by facsimile copies or delivered by electronic communications by portable document format (.pdf), each of which shall be deemed an original. This Agreement will become effective when each party hereto will have received a counterpart hereof signed by the other party hereto. Until and unless each party has received a counterpart hereof signed by the other party hereto, this Agreement will have no effect and no party will have any right or obligation hereunder (whether by virtue of any oral or written agreement or any other communication).

Section 7.12 Termination.

This Agreement will automatically terminate and be of no further force or effect and, except as provided in Section 3.2, the parties hereto will have no further liability hereunder, and the CVRs will expire without any consideration or compensation therefor, upon the expiration of the CVR Period. The termination of this Agreement will not affect or limit the right of Holders to receive the CVR Payments under Section 2.4 to the extent earned prior to the termination of this Agreement, and the provisions applicable thereto will survive the expiration or termination of this Agreement.

 

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Section 7.13 Force Majeure.

Notwithstanding anything to the contrary contained herein, none of the Rights Agent, Homology or any of its Subsidiaries (except as it relates to the obligations of the Company under Article 3) will be liable for any delays or failures in performance resulting from acts beyond its reasonable control including acts of God, pandemics (including COVID-19), terrorist acts, shortage of supply, breakdowns or malfunctions, interruptions or malfunctions of computer facilities, or loss of data due to power failures or mechanical difficulties with information storage or retrieval systems, labor difficulties, war or civil unrest.

Section 7.14 Construction.

 

(a)

For purposes of this Agreement, whenever the context requires: singular terms will include the plural, and vice versa; the masculine gender will include the feminine and neuter genders; the feminine gender will include the masculine and neuter genders; and the neuter gender will include the masculine and feminine genders.

 

(b)

As used in this Agreement, the words “include” and “including,” and variations thereof, will not be deemed to be terms of limitation, but rather will be deemed to be followed by the words “without limitation.”

 

(c)

The headings contained in this Agreement are for convenience of reference only, will not be deemed to be a part of this Agreement and will not be referred to in connection with the construction or interpretation of this Agreement.

 

(d)

Any reference in this Agreement to a date or time shall be deemed to be such date or time in New York City, United States, unless otherwise specified. The parties hereto and Homology have participated jointly in the negotiation and drafting of this Agreement. In the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the parties and Homology and no presumption or burden of proof shall arise favoring or disfavoring any Person by virtue of the authorship of any provision of this Agreement.

 

(e)

All references herein to “$” are to United States Dollars.

[Remainder of page intentionally left blank]

 

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IN WITNESS WHEREOF, each of the parties has caused this Agreement to be executed as of the day and year first above written.

 

[__]
By:  

 

Name:
Title:
EQUINITI TRUST COMPANY, LLC, as Rights Agent
By:  

 

Name:
Title:

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Annex E

Final Form

LOCK-UP AGREEMENT

November 16, 2023

Q32 Bio Inc.

830 Winter St.

Waltham, MA 02451

Ladies and Gentlemen:

The undersigned signatory of this lock-up agreement (this “Lock-Up Agreement”) understands that Homology Medicines, Inc., a Delaware corporation (“Homology”), has entered into an Agreement and Plan of Merger, dated as of November 16, 2023 (as the same may be amended from time to time, the “Merger Agreement”) with Kenobi Merger Sub, Inc., a Delaware corporation and a direct, wholly owned subsidiary of Homology, and Q32 Bio Inc., a Delaware corporation (the “Company”). Capitalized terms used but not otherwise defined herein shall have the respective meanings ascribed to such terms in the Merger Agreement.

As a condition and inducement to each of the parties to enter into the Merger Agreement, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the undersigned hereby irrevocably agrees that, subject to the exceptions set forth herein, without the prior written consent of Homology and, solely prior to the Closing, the Company, the undersigned will not, during the period commencing upon the Closing and ending on the date that is 180 days after the Closing Date (the “Restricted Period”):

 

  (i)

offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly, any shares of Homology Common Stock or any securities convertible into or exercisable or exchangeable for Homology Common Stock (including without limitation, Homology Common Stock or such other securities which may be deemed to be beneficially owned (as such term is used in Rule 13d-3 of the Exchange Act) by the undersigned in accordance with the rules and regulations of the SEC and securities of Homology which may be issued upon exercise of an option to purchase Homology Common Stock or warrant or settlement of a Homology Restricted Stock Unit) that are currently or hereafter owned of record or beneficially (including holding as a custodian) by the undersigned (collectively, the “Undersigned’s Shares”), or publicly disclose the intention to make any such offer, sale, pledge, grant, transfer or disposition;

 

  (ii)

enter into any swap, short sale, hedge or other agreement that transfers, in whole or in part, any of the economic consequences of ownership of the Undersigned’s Shares regardless of whether any such transaction described in clause (i) above or this clause (ii) is to be settled by delivery of Homology Common Stock or other securities, in cash or otherwise; or

 

  (iii)

make any demand for, or exercise any right with respect to, the registration of any shares of Homology Common Stock or any security convertible into or exercisable or exchangeable for Homology Common Stock (other than such rights set forth in the Merger Agreement).

The restrictions and obligations contemplated by this Lock-Up Agreement shall not apply to:

(a) transfers of the Undersigned’s Shares:

 

  (i)

if the undersigned is a natural person, (A) to any person related to the undersigned by blood or adoption who is an immediate family member of the undersigned, or by marriage or domestic partnership (a “Family Member”), or to a trust formed for the direct or indirect benefit of the undersigned or any of the undersigned’s Family Members, (B) to the undersigned’s estate,

 

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  following the death of the undersigned, by will, intestacy or other operation of Law, (C) as a bona fide gift or a charitable contribution, as such term is described in Section 501(c)(3) of the Internal Revenue Code of 1986, as amended, (D) by operation of Law pursuant to a qualified domestic order or in connection with a divorce settlement, or (E) to any partnership, corporation or limited liability company which is controlled by the undersigned and/or by any such Family Member(s);

 

  (ii)

if the undersigned is a corporation, partnership, limited liability company or other entity, (A) to another corporation, partnership, limited liability company, or other entity that is an affiliate (as defined under Rule 12b-2 of the Exchange Act) of the undersigned, including investment funds or other entities under common control or management or advisement with the undersigned (including, for the avoidance of doubt, where the undersigned is a partnership, to its general partner or a successor partnership or fund, or any other funds managed by such partnership), (B) as a distribution or dividend to equity holders, including, without limitation, current or former general or limited partners, members or managers (or to the estates of any of the foregoing), as applicable, of the undersigned (including upon the liquidation and dissolution of the undersigned pursuant to a plan of liquidation approved by the undersigned’s equity holders), (C) as a bona fide gift or a charitable contribution, as such term is described in Section 501(c)(3) of the Internal Revenue Code of 1986, as amended, (D) transfers or dispositions not involving a change in beneficial ownership or (E) with prior written consent of Homology; or

 

  (iii)

if the undersigned is a trust, to any grantors or beneficiaries of the trust;

provided that, in the case of any transfer or distribution pursuant to this clause (a), such transfer is not for value and each donee, heir, beneficiary or other transferee or distributee shall sign and deliver to Homology a lock-up agreement in the form of this Lock-Up Agreement with respect to the shares of Homology Common Stock or such other securities that have been so transferred or distributed;

(b) the exercise of an option to purchase Homology Common Stock (including a net or cashless exercise of an option to purchase Homology Common Stock), and any related transfer of shares of Homology Common Stock to Homology or sale of Homology Common Stock in the open market, in each case, for the purpose of paying the exercise price of such options or for paying taxes (including estimated taxes) during the Restricted Period due as a result of the exercise of such options; provided that, for the avoidance of doubt, the underlying shares of Homology Common Stock held by the undersigned following such exercise and any such open market sales shall continue to be subject to the restrictions on transfer set forth in this Lock-Up Agreement;

(c) the disposition (including a forfeiture or repurchase) to Homology of any shares of restricted stock granted pursuant to the terms of any employee benefit plan or restricted stock purchase agreement;

(d) the vesting of any restricted stock unit or settlement of any other equity award that represents the right to receive shares of Homology Common Stock, and transfers to Homology, or sales of Homology Common Stock in the open market, in connection with the vesting of any restricted stock unit or settlement of any other equity award that represents the right to receive shares of Homology Common Stock settled in Homology Common Stock, in each case, to pay any tax withholding obligations due during the Restricted Period; provided that, for the avoidance of doubt, the underlying shares of Homology Common Stock held by the undersigned following vesting or settlement and any such open market sales shall continue to be subject to the restrictions on transfer set forth in this Lock-Up Agreement;

(e) the establishment of a trading plan pursuant to Rule 10b5-1 under the Exchange Act (a “10b5-1 Plan”) for the transfer of Homology Common Stock; provided that such plan does not provide for any transfers of Homology Common Stock during the Restricted Period, or the sale of Homology Common Stock pursuant to a 10b5-1 Plan existing as of the date of the Merger Agreement (which, for clarity, shall not be amended during the Restricted Period, but may be terminated during the Restricted Period);

(f) transfers, sales, dispositions, or the entering into of transactions (including, without limitation, any swap, hedge or similar agreement) by the undersigned of or relating to shares of capital stock or other securities of

 

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Homology purchased or acquired by the undersigned on the open market, in a public offering by Homology, or that otherwise do not involve or relate to shares of Homology Common Stock issued pursuant to the Merger Agreement in respect of shares of the Company;

(g) pursuant to a bona-fide third party tender offer, merger, consolidation or other similar transaction made to all holders of Homology’s capital stock involving a change of control of Homology, provided that in the event that such tender offer, merger, consolidation or other such transaction is not completed, the Undersigned’s Shares shall remain subject to the restrictions contained in this Lock-Up Agreement; or

(h) pursuant to an order of a court or regulatory agency.

And provided, further, that, with respect to each of (a), (b), (c), (d) and (e) above, no filing by any party (including any donor, donee, transferor, transferee, distributor or distributee) under Section 16 of the Exchange Act or other public announcement shall be made voluntarily in connection with such transfer or disposition during the Restricted Period; provided that (i) any filing under Section 16 of the Exchange Act made during the Restricted Period shall clearly indicate in the footnotes thereto that such filing relates to the circumstances described in (a), (b), (c), (d) or (e), as applicable and (ii) the foregoing shall not prevent the undersigned from filing a Form 13F, Schedule 13G or Schedule 13D, or any amendment thereto, or from disclosing its holdings in Homology as required by law or regulation or its internal disclosure policies in the ordinary course of business.

Any attempted transfer in violation of this Lock-Up Agreement will be of no effect and null and void, regardless of whether the purported transferee has any actual or constructive knowledge of the transfer restrictions set forth in this Lock-Up Agreement, and will not be recorded on the share register of Homology. In furtherance of the foregoing, the undersigned agrees that Homology and any duly appointed transfer agent for the registration or transfer of the securities described herein are hereby authorized to decline to make any transfer of securities if such transfer would constitute a violation or breach of this Lock-Up Agreement. Homology may cause the legend set forth below, or a legend substantially equivalent thereto, to be placed upon any certificate(s) or other documents, ledgers or instruments evidencing the undersigned’s ownership of Homology Common Stock:

THE SHARES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO AND MAY ONLY BE TRANSFERRED IN COMPLIANCE WITH A LOCK-UP AGREEMENT, A COPY OF WHICH IS ON FILE AT THE PRINCIPAL OFFICE OF THE COMPANY.

The undersigned hereby represents and warrants that the undersigned has full power and authority to enter into this Lock-Up Agreement. All authority herein conferred or agreed to be conferred and any obligations of the undersigned shall be binding upon the successors, assigns, heirs or personal representatives of the undersigned.

The undersigned understands that if the Merger Agreement is terminated for any reason, the undersigned shall be released from all obligations under this Lock-Up Agreement. The undersigned understands that Homology and the Company are proceeding with the Contemplated Transactions in reliance upon this Lock-Up Agreement. Notwithstanding anything to the contrary contained herein, this letter agreement will automatically terminate and the undersigned shall be released from all obligations under this letter agreement upon the earliest to occur, if any, of (i) the Company advising the undersigned in writing that it has determined not to proceed with the Contemplated Transactions or (ii) the Merger Agreement being terminated.

Any and all remedies herein expressly conferred upon Homology or the Company will be deemed cumulative with and not exclusive of any other remedy conferred hereby, or by Law or equity, and the exercise by Homology or the Company of any one remedy will not preclude the exercise of any other remedy. The undersigned agrees that irreparable damage could occur to Homology and/or the Company in the event that any provision of this Lock-Up Agreement were not performed in accordance with its specific terms or were otherwise breached. It is accordingly agreed that Homology and the Company shall be entitled to seek an injunction or

 

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injunctions to prevent breaches of this Lock-Up Agreement and to enforce specifically the terms and provisions hereof in any court of the United States or any state having jurisdiction, this being in addition to any other remedy to which Homology or the Company is entitled at Law or in equity, and the undersigned waives any bond, surety or other security that might be required of Homology or the Company with respect thereto.

In the event that any holder of Homology’s securities that are subject to a substantially similar agreement entered into by such holder, other than the undersigned, is permitted by Homology (or prior to the Closing, the Company), including through any written consent granted under subparagraph a(ii)(E) above, to sell or otherwise transfer or dispose of shares of Homology Common Stock for value other than as permitted by this or a substantially similar agreement entered into by such holder or is granted an early release from the restrictions described herein during the Restricted Period, the same percentage of shares of the Undersigned’s Shares shall be immediately and fully released on the same terms from any remaining restrictions set forth herein (the “Pro-Rata Release”); provided, however, that such Pro-Rata Release shall not be applied unless and until permission or early release has been granted by Homology, and solely prior to the Closing, the Company, to an equity holder or equity holders to sell or otherwise transfer or dispose of all or a portion of such equity holder’s shares of Homology Common Stock that, when combined with all such other such permissions and early releases, represent an aggregate amount in excess of 1% of the number of shares of Homology Common Stock originally subject to a substantially similar agreements. Homology shall notify the undersigned of any Pro Rata Release of its shares on the same day that any permission that triggers the Pro Rata Release is granted.

Upon the release of any of the Undersigned’s Shares from this Lock-Up Agreement, Homology will cooperate with the undersigned to facilitate the timely preparation and delivery of certificates representing the Undersigned’s Shares without the restrictive legend above or the withdrawal of any stop transfer instructions.

This Lock-Up Agreement and any claim, controversy or dispute arising under or related to this Lock-Up Agreement shall be governed by and construed in accordance with the Laws of the State of Delaware, without regard to the conflict of Laws principles thereof.

This Lock-Up Agreement may be executed in several counterparts, each of which shall be deemed an original and all of which shall constitute one and the same instrument. The exchange of a fully executed Lock-Up Agreement (in counterparts or otherwise) by Homology, the Company and the undersigned by facsimile, electronic mail (including any electronic signature covered by the U.S. federal ESIGN Act of 2000, Uniform Electronic Transactions Act, the Electronic Signatures and Records Act or other applicable law, e.g., www.docusign.com) or electronic transmission in .pdf format shall be sufficient to bind such parties to the terms and conditions of this Lock-Up Agreement.

(Signature Page Follows)

 

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   Very truly yours,

Print Name of Stockholder:

   [                             ]
   Signature (for individuals):
  

 

 

Accepted and Agreed

By Homology Medicines, Inc.:

By:  

 

  Name:                                                                            
  Title:                                                                              
Accepted and Agreed by Q32 Bio Inc.:
By:  

 

  Name:                                                                            
  Title:                                                                              

[Signature Page to Lock-up Agreement]


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Annex F

Final Form

LOCK-UP AGREEMENT

November 16, 2023

Q32 Bio Inc.

830 Winter St.

Waltham, MA 02451

Ladies and Gentlemen:

The undersigned signatory of this lock-up agreement (this “Lock-Up Agreement”) understands that Homology Medicines, Inc., a Delaware corporation (“Homology”), has entered into an Agreement and Plan of Merger, dated as of November 16, 2023 (as the same may be amended from time to time, the “Merger Agreement”) with Kenobi Merger Sub, Inc., a Delaware corporation and a direct, wholly owned subsidiary of Homology, and Q32 Bio Inc., a Delaware corporation (the “Company”). Capitalized terms used but not otherwise defined herein shall have the respective meanings ascribed to such terms in the Merger Agreement.

As a condition and inducement to each of the parties to enter into the Merger Agreement, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the undersigned hereby irrevocably agrees that, subject to the exceptions set forth herein, without the prior written consent of Homology and, solely prior to the Closing, the Company, the undersigned will not, during the period commencing upon the Closing and ending on the date that is 180 days after the Closing Date (the “Restricted Period”):

 

  (i)

offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly, any shares of Homology Common Stock or any securities convertible into or exercisable or exchangeable for Homology Common Stock (including without limitation, Homology Common Stock or such other securities which may be deemed to be beneficially owned (as such term is used in Rule 13d-3 of the Exchange Act) by the undersigned in accordance with the rules and regulations of the SEC and securities of Homology which may be issued upon exercise of an option to purchase Homology Common Stock or warrant or settlement of a Homology Restricted Stock Unit) that are currently or hereafter owned of record or beneficially (including holding as a custodian) by the undersigned (collectively, the “Undersigned’s Shares”), or publicly disclose the intention to make any such offer, sale, pledge, grant, transfer or disposition;

 

  (ii)

enter into any swap, short sale, hedge or other agreement that transfers, in whole or in part, any of the economic consequences of ownership of the Undersigned’s Shares regardless of whether any such transaction described in clause (i) above or this clause (ii) is to be settled by delivery of Homology Common Stock or other securities, in cash or otherwise; or

 

  (iii)

make any demand for, or exercise any right with respect to, the registration of any shares of Homology Common Stock or any security convertible into or exercisable or exchangeable for Homology Common Stock (other than such rights set forth in the Merger Agreement or the obligations of the Company or the combined company under the Registration Rights Agreement).

The restrictions and obligations contemplated by this Lock-Up Agreement shall not apply to:

 

  (a)

transfers of the Undersigned’s Shares:

 

  (i)

if the undersigned is a natural person, (A) to any person related to the undersigned by blood or adoption who is an immediate family member of the undersigned, or by marriage or domestic partnership (a “Family Member”), or to a trust formed for the direct or indirect benefit of the undersigned or any of the undersigned’s Family Members, (B) to the undersigned’s estate,

 

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  following the death of the undersigned, by will, intestacy or other operation of Law, (C) as a bona fide gift or a charitable contribution, as such term is described in Section 501(c)(3) of the Internal Revenue Code of 1986, as amended, (D) by operation of Law pursuant to a qualified domestic order or in connection with a divorce settlement, or (E) to any partnership, corporation or limited liability company which is controlled by the undersigned and/or by any such Family Member(s);

 

  (ii)

if the undersigned is a corporation, partnership, limited liability company or other entity, (A) to another corporation, partnership, limited liability company, or other entity that is an affiliate (as defined under Rule 12b-2 of the Exchange Act) of the undersigned, including investment funds or other entities under common control or management or advisement with the undersigned (including, for the avoidance of doubt, where the undersigned is a partnership, to its general partner or a successor partnership or fund, or any other funds managed by such partnership), (B) as a distribution or dividend to equity holders, including, without limitation, current or former general or limited partners, members or managers (or to the estates of any of the foregoing), as applicable, of the undersigned (including upon the liquidation and dissolution of the undersigned pursuant to a plan of liquidation approved by the undersigned’s equity holders), (C) as a bona fide gift or a charitable contribution, as such term is described in Section 501(c)(3) of the Internal Revenue Code of 1986, as amended, (D) transfers or dispositions not involving a change in beneficial ownership or (E) with prior written consent of Homology; or

 

  (iii)

if the undersigned is a trust, to any grantors or beneficiaries of the trust;

provided that, in the case of any transfer or distribution pursuant to this clause (a), such transfer is not for value and each donee, heir, beneficiary or other transferee or distributee shall sign and deliver to Homology a lock-up agreement in the form of this Lock-Up Agreement with respect to the shares of Homology Common Stock or such other securities that have been so transferred or distributed;

(b) the exercise of an option to purchase Homology Common Stock (including a net or cashless exercise of an option to purchase Homology Common Stock), and any related transfer of shares of Homology Common Stock to Homology or sale of Homology Common Stock in the open market, in each case, for the purpose of paying the exercise price of such options or for paying taxes (including estimated taxes) during the Restricted Period due as a result of the exercise of such options; provided that, for the avoidance of doubt, the underlying shares of Homology Common Stock held by the undersigned following such exercise and any such open market sales shall continue to be subject to the restrictions on transfer set forth in this Lock-Up Agreement;

(c) the disposition (including a forfeiture or repurchase) to Homology of any shares of restricted stock granted pursuant to the terms of any employee benefit plan or restricted stock purchase agreement;

(d) the vesting of any restricted stock unit or settlement of any other equity award that represents the right to receive shares of Homology Common Stock, and transfers to Homology, or sales of Homology Common Stock in the open market, in connection with the vesting of any restricted stock unit or settlement of any other equity award that represents the right to receive shares of Homology Common Stock settled in Homology Common Stock, in each case, to pay any tax withholding obligations due during the Restricted Period; provided that, for the avoidance of doubt, the underlying shares of Homology Common Stock held by the undersigned following such vesting or settlement and any such open market sales shall continue to be subject to the restrictions on transfer set forth in this Lock-Up Agreement;

(e) the establishment of a trading plan pursuant to Rule 10b5-1 under the Exchange Act (a “10b5-1 Plan”) for the transfer of Homology Common Stock; provided that such plan does not provide for any transfers of Homology Common Stock during the Restricted Period, or the sale of Homology Common Stock pursuant to a 10b5-1 Plan existing as of the date of the Merger Agreement (which, for clarity, shall not be amended during the Restricted Period, but may be terminated during the Restricted Period);

 

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(f) transfers, sales, dispositions, or the entering into of transactions (including, without limitation, any swap, hedge or similar agreement) by the undersigned of or relating to shares of capital stock or other securities of Homology purchased or acquired by the undersigned on the open market, in a public offering by Homology, or that otherwise do not involve or relate to shares of Homology Common Stock issued pursuant to the Merger Agreement in respect of shares of the Company;

(g) pursuant to a bona-fide third party tender offer, merger, consolidation or other similar transaction made to all holders of Homology’s capital stock involving a change of control of Homology, provided that in the event that such tender offer, merger, consolidation or other such transaction is not completed, the Undersigned’s Shares shall remain subject to the restrictions contained in this Lock-Up Agreement; or

(h) pursuant to an order of a court or regulatory agency;

(i) Transfers, sales, dispositions, or the entering into of transactions (including, without limitation, any swap, hedge, or similar agreement), by the undersigned relating to shares of Homology Common Stock issued pursuant to the Merger Agreement in respect of shares of the Company, if any, purchased from the Company pursuant to the Concurrent Financing (as defined in the Merger Agreement) (the “Q32 Concurrent Financing Released Shares”) or issued in exchange for, or on conversion or exercise of, any securities issued as part of the Concurrent Financing. The number of Q32 Concurrent Financing Released Shares held by each stockholder of the Company is set forth opposite his, her or its name on Schedule I to this Lock-up Agreement under the heading “Q32 Concurrent Financing Released Shares”.

And provided, further, that, with respect to each of (a), (b), (c), (d) and (e) above, no filing by any party (including any donor, donee, transferor, transferee, distributor or distributee) under Section 16 of the Exchange Act or other public announcement shall be made voluntarily in connection with such transfer or disposition during the Restricted Period; provided that (i) any filing under Section 16 of the Exchange Act made during the Restricted Period shall clearly indicate in the footnotes thereto that such filing relates to the circumstances described in (a), (b), (c), (d) or (e), as applicable and (ii) the foregoing shall not prevent the undersigned from filing a Form 13F, Schedule 13G or Schedule 13D, or any amendment thereto, or from disclosing its holdings in Homology as required by law or regulation or its internal disclosure policies in the ordinary course of business.

Any attempted transfer in violation of this Lock-Up Agreement will be of no effect and null and void, regardless of whether the purported transferee has any actual or constructive knowledge of the transfer restrictions set forth in this Lock-Up Agreement, and will not be recorded on the share register of Homology. In furtherance of the foregoing, the undersigned agrees that Homology and any duly appointed transfer agent for the registration or transfer of the securities described herein are hereby authorized to decline to make any transfer of securities if such transfer would constitute a violation or breach of this Lock-Up Agreement. Homology may cause the legend set forth below, or a legend substantially equivalent thereto, to be placed upon any certificate(s) or other documents, ledgers or instruments evidencing the undersigned’s ownership of Homology Common Stock:

THE SHARES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO AND MAY ONLY BE TRANSFERRED IN COMPLIANCE WITH A LOCK-UP AGREEMENT, A COPY OF WHICH IS ON FILE AT THE PRINCIPAL OFFICE OF THE COMPANY.

The undersigned hereby represents and warrants that the undersigned has full power and authority to enter into this Lock-Up Agreement. All authority herein conferred or agreed to be conferred and any obligations of the undersigned shall be binding upon the successors, assigns, heirs or personal representatives of the undersigned.

The undersigned understands that if the Merger Agreement is terminated for any reason, the undersigned shall be released from all obligations under this Lock-Up Agreement. The undersigned understands that Homology and the Company are proceeding with the Contemplated Transactions in reliance upon this Lock-Up Agreement. Notwithstanding anything to the contrary contained herein, this letter agreement will automatically

 

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terminate and the undersigned shall be released from all obligations under this letter agreement upon the earliest to occur, if any, of (i) the Company advising the undersigned in writing that it has determined not to proceed with the Contemplated Transactions or (ii) the Merger Agreement being terminated.

Any and all remedies herein expressly conferred upon Homology or the Company will be deemed cumulative with and not exclusive of any other remedy conferred hereby, or by Law or equity, and the exercise by Homology or the Company of any one remedy will not preclude the exercise of any other remedy. The undersigned agrees that irreparable damage could occur to Homology and/or the Company in the event that any provision of this Lock-Up Agreement were not performed in accordance with its specific terms or were otherwise breached. It is accordingly agreed that Homology and the Company shall be entitled to seek an injunction or injunctions to prevent breaches of this Lock-Up Agreement and to enforce specifically the terms and provisions hereof in any court of the United States or any state having jurisdiction, this being in addition to any other remedy to which Homology or the Company is entitled at Law or in equity, and the undersigned waives any bond, surety or other security that might be required of Homology or the Company with respect thereto.

In the event that any holder of Homology’s securities that are subject to a substantially similar agreement entered into by such holder, other than the undersigned, is permitted by Homology (or prior to the Closing, the Company), including through any written consent granted under subparagraph a(ii)(E) above, to sell or otherwise transfer or dispose of shares of Homology Common Stock for value other than as permitted by this or a substantially similar agreement entered into by such holder or is granted an early release from the restrictions described herein during the Restricted Period, the same percentage of shares of the Undersigned’s Shares shall be immediately and fully released on the same terms from any remaining restrictions set forth herein (the “Pro-Rata Release”); provided, however, that such Pro-Rata Release shall not be applied unless and until permission or early release has been granted by Homology, and solely prior to the Closing, the Company, to an equity holder or equity holders to sell or otherwise transfer or dispose of all or a portion of such equity holder’s shares of Homology Common Stock that, when combined with all such other such permissions and early releases, represent an aggregate amount in excess of 1% of the number of shares of Homology Common Stock originally subject to a substantially similar agreements. Homology shall notify the undersigned of any Pro Rata Release of its shares on the same day that any permission that triggers the Pro Rata Release is granted.

Upon the release of any of the Undersigned’s Shares from this Lock-Up Agreement, Homology will cooperate with the undersigned to facilitate the timely preparation and delivery of certificates representing the Undersigned’s Shares without the restrictive legend above or the withdrawal of any stop transfer instructions.

This Lock-Up Agreement and any claim, controversy or dispute arising under or related to this Lock-Up Agreement shall be governed by and construed in accordance with the Laws of the State of Delaware, without regard to the conflict of Laws principles thereof.

This Lock-Up Agreement may be executed in several counterparts, each of which shall be deemed an original and all of which shall constitute one and the same instrument. The exchange of a fully executed Lock-Up Agreement (in counterparts or otherwise) by Homology, the Company and the undersigned by facsimile, electronic mail (including any electronic signature covered by the U.S. federal ESIGN Act of 2000, Uniform Electronic Transactions Act, the Electronic Signatures and Records Act or other applicable law, e.g., www.docusign.com) or electronic transmission in .pdf format shall be sufficient to bind such parties to the terms and conditions of this Lock-Up Agreement.

(Signature Page Follows)

 

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   Very truly yours,

Print Name of Stockholder:

   [                             ]
   Signature (for individuals):
  

 

   Signature (for entities):
   By:   

 

      Name:                               
      Title:                                  

 

Accepted and Agreed

By Homology Medicines, Inc.:

By:  

 

  Name:                                                                            
  Title:                                                                              
Accepted and Agreed by Q32 Bio Inc.:
By:  

 

  Name:                                                                            
  Title:                                                                              


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Annex G

PROPOSED AMENDMENT TO RESTATED CERTIFICATE OF INCORPORATION

CERTIFICATE OF AMENDMENT TO

RESTATED CERTIFICATE OF INCORPORATION

OF

HOMOLOGY MEDICINES, INC.

Homology Medicines, Inc., a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware (the “Corporation”), does hereby certify as follows:

 

FIRST:

That the board of directors of the Corporation duly adopted resolutions recommending and declaring advisable that the Restated Certificate of Incorporation of the Corporation be amended and that such amendment be submitted to the stockholders of the Corporation for their consideration, as follows:

 

  

RESOLVED, that the first sentence of Article FOURTH of the Restated Certificate of Incorporation be, and hereby is, amended and restated in its entirety to read as follows:

 

    

“Authorized Stock. The total number of shares of all classes of stock which the Corporation shall have authority to issue is 410,000,000 shares, consisting of (a) 400,000,000 shares of Common Stock, $0.0001 par value per share (“Common Stock”), and (b) 10,000,000 shares of Preferred Stock, $0.0001 par value per share (“Preferred Stock”).

 

    

Reverse Stock Split. That, effective at 5:00 p.m., Eastern time, on the date this Certificate of Amendment to the Restated Certificate of Incorporation is filed with the Secretary of State of the State of Delaware (the “Effective Time”), a one-for-[    ]1 reverse stock split of the Common Stock (as defined below) shall become effective, pursuant to which each [    ]3 shares of Common Stock issued and held of record by each stockholder of the Corporation (including treasury shares) immediately prior to the Effective Time shall be reclassified and combined into

  one validly issued, fully paid and nonassessable share of Common Stock automatically and without any action by the holder thereof upon the Effective Time and shall represent one share of Common Stock from and after the Effective Time (such reclassification and combination of shares, the “Reverse Stock Split”). No fractional shares of Common Stock shall be issued as a result of the Reverse Stock Split and, in lieu thereof, (a) with respect to holders of one or more certificates, if any, which formerly represented shares of Common Stock that were issued and outstanding immediately prior to the Effective Time, upon surrender after the Effective Time of such certificate or certificates, any holder who would otherwise be entitled to a fractional share of Common Stock as a result of the Reverse Stock Split, following the Effective Time, shall be entitled to receive a cash payment (the “Fractional Share Payment”) equal to the fraction of which such holder would otherwise be entitled multiplied by the closing price per share of Common Stock on the date of the Effective Time as reported by The Nasdaq Global Select Market (as adjusted to give effect to the Reverse Stock Split); provided that, whether or not fractional shares would be issuable as a result of the Reverse Stock Split shall be determined on the basis of (i) the total number of shares of Common Stock that were issued and outstanding immediately prior to the Effective Time formerly represented by certificates that the holder is at the time surrendering and (ii) the aggregate number of shares of Common Stock

 

1 

Shall be a whole number between and including 1-for-        and 1-for-        , which number is referred to as the “Reverse Split Factor” (it being understood that any Reverse Split Factor within such range shall, together with the remaining provisions of this Certificate of Amendment not appearing in brackets, constitute a separate amendment being approved and adopted by the Board and stockholders in accordance with Section 242 of the Delaware General Corporation Law).

 

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  after the Effective Time into which the shares of Common Stock formerly represented by such certificates shall have been reclassified; and (b) with respect to holders of shares of Common Stock in book-entry form in the records of the Corporation’s transfer agent that were issued and outstanding immediately prior to the Effective Time, any holder who would otherwise be entitled to a fractional share of Common Stock as a result of the Reverse Stock Split (after aggregating all fractional shares), following the Effective Time, shall be entitled to receive the Fractional Share Payment automatically and without any action by the holder.”

 

SECOND:

That, at a meeting of stockholders of the Corporation, the aforesaid amendment was duly adopted by the stockholders of the Corporation.

 

THIRD:

That the aforesaid amendment was duly adopted in accordance with the applicable provisions of Section 242 of the General Corporation Law of the State of Delaware.

IN WITNESS WHEREOF, the Corporation has caused this Certificate of Amendment to be signed by its [    ] on this [    ] day of [    ] 2024.

 

HOMOLOGY MEDICINES, INC.
By:  

 

Name:  
Title:  

 

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Annex H

Opinion of Cowen and Company, LLC

November 15, 2023

The Board of Directors

Homology Medicines, Inc.

One Patriots Park

Bedford, Massachusetts 01730

The Board of Directors:

In your capacity as the Board of Directors (the “Board of Directors”) of Homology Medicines, Inc. (“Homology”), you have requested our opinion (the “Opinion”), as investment bankers, as to the fairness, from a financial point of view, to Homology of the Q32 Equity Value (as defined below) provided for pursuant to the terms of an Agreement and Plan of Merger (the “Merger Agreement”) proposed to be entered into among Homology, Kenobi Merger Sub, Inc., a wholly owned subsidiary of Homology (“Merger Sub”), and Q32 Bio Inc. (“Q32”).

As more fully described in the Merger Agreement, and subject to the terms and conditions set forth therein, Merger Sub will be merged with and into Q32 (the “Merger”), with Q32 surviving the Merger as a wholly owned subsidiary of Homology, in connection with which Q32 will be ascribed an aggregate equity value of $195 million (the “Q32 Equity Value”).

We understand that, in connection with the Merger, (i) all outstanding shares of the common stock, par value $0.0001 per share, of Q32 (“Q32 Common Stock”) will be converted into the right to receive shares of the common stock, par value $0.0001 per share, of Homology (“Homology Common Stock”), (ii) Q32 will effect the conversion of all outstanding shares of preferred stock of Q32 (“Q32 Preferred Stock”) and all outstanding convertible notes of Q32 (“Q32 Convertible Notes”) into shares of Q32 Common Stock immediately prior to the effective time of the Merger, (iii) Homology may dispose of its assets and rights relating to its HMI-103 (Adult/Pediatric PKU), HMI-203 (MPS II (Hunter Syndrome)), HMI-204 (MLD), capsids and AAVHSC platform, including any equity interests held by Homology in Oxford Biomedica Solutions, LLC or its affiliates (collectively, the “Homology Legacy Assets”), and holders of Homology Common Stock will receive contingent value rights relating to the net proceeds received from any such disposition (or commercialization of any such assets) occurring within a specified disposition period (“Homology CVRs”), (iv) Q32 will consummate a financing immediately prior to the effective time of the Merger through the private placement of its capital stock for aggregate gross cash proceeds of at least $42 million based on a pre-money equity valuation for Q32 equal to the Q32 Equity Value (the “Concurrent Financing”) and (v) Homology will effect a reverse stock split of all outstanding shares of Homology Common Stock prior to the effective time of the Merger (the transactions described in the foregoing clauses (i) through (v) and the other transactions contemplated by the Merger Agreement (other than the Merger), collectively, the “related transactions”). The terms and conditions of the Merger and the related transactions are more fully set forth in the Merger Agreement and related documents.

Cowen and Company, LLC (“we” or “TD Cowen”), as part of its investment banking business, is continually engaged in the valuation of businesses and their securities in connection with mergers and acquisitions, negotiated underwritings, secondary distributions of listed and unlisted securities, private placements and valuations for corporate and other purposes. In the ordinary course of our business, we and our affiliates may actively trade the securities of Homology and/or its affiliates for our own account and for the accounts of our customers and, accordingly, may at any time hold a long or short position in such securities.

We are acting as financial advisor to Homology in connection with the Merger and will receive a fee from Homology for our services, a significant portion of which is contingent upon consummation of the Merger. We

 

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also will receive a fee in connection with this Opinion. In addition, Homology has agreed to reimburse our expenses and indemnify us for certain liabilities that may arise out of our engagement. TD Cowen in the past has provided, currently is providing and in the future may provide financial advisory and/or investment banking services to Homology and/or its affiliates unrelated to the Merger, for which services TD Cowen has received and expects to receive compensation, including during the two years preceding the date of this Opinion having served as sales agent for certain at-the-market offerings of Homology Common Stock. Although TD Cowen has not had a material relationship with Q32 during the two years preceding the date of this Opinion, TD Cowen in the future may provide services to Q32 and/or its affiliates and may receive compensation for the rendering of such services.

In connection with our Opinion, we have reviewed and considered such financial and other matters as we have deemed relevant, including, among other things:

 

  •  

a final form, provided to us on November 15, 2023, of the Merger Agreement;

 

  •  

certain publicly available financial and other information for Homology and certain other relevant financial and operating data furnished to TD Cowen by the management of Homology;

 

  •  

certain financial and other information for Q32 and certain other relevant financial and operating data furnished to TD Cowen by the managements of Homology and Q32;

 

  •  

certain internal financial analyses, probability-adjusted financial forecasts, reports and other information concerning Q32 prepared by the management of Q32 as adjusted by the management of Homology (as adjusted, the “Q32 Forecasts”);

 

  •  

discussions we have had with certain members of the managements of Homology and Q32, as the case may be, concerning the historical and current business operations, financial conditions and prospects of Homology and Q32 and such other matters that we deemed relevant;

 

  •  

certain operating results of, and financial information for, Q32 as compared to similar information for certain publicly traded companies that we deemed relevant; and

 

  •  

such other information, financial studies, analyses and investigations and such other factors that we deemed relevant for the purposes of this Opinion.

In conducting our review and arriving at our Opinion, we have, at your direction, assumed and relied, without independent investigation, upon the accuracy and completeness of all financial and other information provided to us by Homology and Q32 or which is publicly available or was otherwise reviewed by us. We have not undertaken any responsibility for the accuracy, completeness or reasonableness of, or independent verification of, such information. We have relied upon the respective representations of Homology and Q32 that all information provided to us by Homology and Q32 is accurate and complete in all material respects and we expressly disclaim any undertaking or obligation to advise any person of any change in any fact or matter affecting our Opinion of which we become aware after the date hereof.

We have been advised that, given that Homology’s assets and liabilities are comprised of cash (net of liabilities) and the Homology Legacy Assets (which currently are contemplated to be sold) and that Homology is not expected to have any continuing business operations on a standalone basis other than those incidental to Homology’s status as a publicly traded company, the management of Homology has not prepared financial forecasts relating to Homology. Accordingly, we have not performed a financial analysis of Homology or the Homology CVRs. We also have assumed that, when delivered as contemplated by the Merger Agreement, additional financial statements and other financial information relating to Q32 will not reflect any information that would be meaningful in any respect to our analyses or Opinion. We further have assumed, at your direction, that the Q32 Forecasts (as adjusted by the management of Homology) were reasonably prepared by the managements of Homology and Q32, as the case may be, on bases reflecting the best currently available estimates and good faith judgments of such managements as to the future performance of Q32 and the other matters covered thereby, and that such Q32 Forecasts utilized in our analyses provide a reasonable basis for our

 

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Opinion. We have relied on the assessments of the managements of Homology and Q32 as to, among other things, (i) the product pipeline, future products, technology and intellectual property of Q32, including the viability of and risks associated with such product pipeline, future products, technology and intellectual property, and (ii) the terms of the Concurrent Financing, including with respect to the timing, amount, valuation and other terms involved and potential impact thereof. We have assumed that there will be no developments with respect to any such matters that would have an adverse effect on Q32, Homology, the Merger or the related transactions (including the contemplated benefits thereof) or that otherwise would be meaningful in any respect to our analyses or Opinion. We express no opinion as to the Q32 Forecasts or the assumptions on which they are based.

In addition, we have assumed that there have been no material changes in the assets, liabilities, financial condition, results of operations, businesses or prospects of Q32 or Homology since the dates of the last financial statements made available to us. We have not made or obtained any independent evaluations, valuations or appraisals of the assets or liabilities (contingent, accrued, derivative, off-balance sheet or otherwise) of Q32, Homology or any other entity, nor have we been furnished with such materials. We have not conducted nor have we assumed any obligation to conduct any physical inspection of the properties or facilities of Q32, Homology or any other entity. We also have not evaluated the solvency or fair value of Q32, Homology or any other entity under any state, federal or foreign laws relating to bankruptcy, insolvency or similar matters. In addition, we have not undertaken an independent evaluation of any actual or potential litigation, settlements, governmental or regulatory proceedings or investigations, possible unasserted claims or other contingent liabilities to which Q32, Homology or any other entity may be a party or subject. We have assumed that the Merger will qualify for the intended tax treatment contemplated by the Merger Agreement. Our Opinion does not address any legal, tax, accounting or regulatory matters related to the Merger Agreement, the Merger or any related transactions, as to which we have assumed that Homology and the Board of Directors have received such advice from legal, tax, accounting and regulatory advisors as each has determined appropriate.

Our Opinion addresses only the fairness of the Q32 Equity Value, from a financial point of view, to Homology. We express no view as to any related transactions (including, without limitation, the Concurrent Financing), the Homology CVRs or any other aspect or implication of the Merger, including, without limitation, any support or lock-up agreements, subscription agreements or any other agreement, arrangement or understanding entered into in connection with the Merger, any related transactions or otherwise. Our Opinion is necessarily based upon economic and market conditions and other circumstances as they exist and can be evaluated by us on the date hereof. It should be understood that although subsequent developments may affect our Opinion, we do not have any obligation to update, revise or reaffirm our Opinion and we expressly disclaim any responsibility to do so.

We have not considered any potential legislative or regulatory changes currently being considered or recently enacted by the United States or any foreign government, or any domestic or foreign regulatory body, or any changes in accounting methods or generally accepted accounting principles that may be adopted by the Securities and Exchange Commission, the Financial Accounting Standards Board, or any similar foreign regulatory body or board.

For purposes of rendering our Opinion, we have assumed in all respects material to our analyses that the representations and warranties of each party contained in the Merger Agreement are true and correct, that each party will perform all of the covenants and agreements required to be performed by it under the Merger Agreement and that all conditions to the consummation of the Merger and the related transactions will be satisfied without waiver thereof. We also have assumed that the final executed form of the Merger Agreement will be substantially similar to the final form reviewed by us. We further have assumed that all governmental, regulatory and other consents and approvals contemplated by the Merger Agreement will be obtained and that in the course of obtaining any of those consents no restrictions will be imposed or waivers made that would have an adverse effect on Q32, Homology, the Merger or the related transactions (including the contemplated benefits thereof). In addition, we have assumed that the Merger and the related transactions will be consummated in a manner that complies with the applicable provisions of the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, and all other applicable state or federal statutes, rules and regulations.

 

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It is understood that our Opinion is intended for the benefit and use of the Board of Directors (in its capacity as such) in its evaluation of the Q32 Equity Value. Our Opinion should not be disclosed, referred to, or communicated (in whole or in part) to any third party for any purpose whatsoever except with our prior written approval. However, our Opinion may be reproduced in full in any proxy statement or registration statement relating to the Merger that Homology is required to file under the Securities Exchange Act of 1934, as amended, and mail to securityholders of Homology. Our Opinion does not constitute a recommendation to the Board of Directors on whether or not to approve the Merger or any related transactions or to any securityholder or any other person as to how to vote or act with respect to the Merger, any related transactions or otherwise. We are not expressing any opinion as to the actual value, price or trading range of any securities of Homology (including Homology Common Stock and Homology CVRs) or Q32 (including Q32 Common Stock, Q32 Preferred Stock and Q32 Convertible Notes) upon or following announcement or consummation of the Merger and the related transactions. We have not been requested to opine as to, and our Opinion does not in any manner address, Homology’s underlying business decision to effect the Merger or the related transactions or the relative merits of the Merger or the related transactions as compared to other business strategies or transactions that might be available to Homology, including a liquidation of Homology. In addition, we have not been requested to opine as to, and our Opinion does not in any manner address, (i) the fairness of the amount or nature of the compensation to the officers, directors or employees, or class of such persons, of any parties to the Merger or any related transactions relative to the Q32 Equity Value or otherwise or (ii) the fairness of the Merger, any related transactions or the Q32 Equity Value to the holders of any class of securities, creditors or other constituencies of Homology or Q32.

The issuance of this Opinion was reviewed and approved by TD Cowen’s Fairness Opinion Review Committee.

Based upon and subject to the foregoing, including the various assumptions and limitations set forth herein, it is our opinion that, as of the date hereof, the Q32 Equity Value provided for pursuant to the Merger Agreement is fair, from a financial point of view, to Homology.

Very truly yours,

COWEN AND COMPANY, LLC

 

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Annex I

 

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Annex J

 

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Annex K

SECTION 262 OF THE DELAWARE GENERAL CORPORATION LAW

§262 Appraisal rights.

(a) Any stockholder of a corporation of this state who holds shares of stock on the date of the making of a demand pursuant to subsection (d) of this section with respect to such shares, who continuously holds such shares through the effective date of the merger or consolidation, who has otherwise complied with subsection (d) of this section and who has neither voted in favor of the merger or consolidation nor consented thereto in writing pursuant to § 228 of this title shall be entitled to an appraisal by the Court of Chancery of the fair value of the stockholder’s shares of stock under the circumstances described in subsections (b) and (c) of this section. As used in this section, the word “stockholder” means a holder of record of stock in a corporation; the words “stock” and “share” mean and include what is ordinarily meant by those words; and the words “depository receipt” mean a receipt or other instrument issued by a depository representing an interest in 1 or more shares, or fractions thereof, solely of stock of a corporation, which stock is deposited with the depository.

(b) Appraisal rights shall be available for the shares of any class or series of stock of a constituent corporation in a merger or consolidation to be effected pursuant to § 251 (other than a merger effected pursuant to § 251(g) of this title), § 252, § 254, § 255, § 256, § 257, § 258, § 263 or § 264 of this title:

(1) Provided, however, that, except as expressly provided in § 363(b) of this title, no appraisal rights under this section shall be available for the shares of any class or series of stock, which stock, or depository receipts in respect thereof, at the record date fixed to determine the stockholders entitled to receive notice of the meeting of stockholders to act upon the agreement of merger or consolidation (or, in the case of a merger pursuant to § 251(h), as of immediately prior to the execution of the agreement of merger), were either: (i) listed on a national securities exchange or (ii) held of record by more than 2,000 holders; and further provided that no appraisal rights shall be available for any shares of stock of the constituent corporation surviving a merger if the merger did not require for its approval the vote of the stockholders of the surviving corporation as provided in § 251(f) of this title.

(2) Notwithstanding paragraph (b)(1) of this section, appraisal rights under this section shall be available for the shares of any class or series of stock of a constituent corporation if the holders thereof are required by the terms of an agreement of merger or consolidation pursuant to §§ 251, 252, 254, 255, 256, 257, 258, 263 and 264 of this title to accept for such stock anything except:

a. Shares of stock of the corporation surviving or resulting from such merger or consolidation, or depository receipts in respect thereof;

b. Shares of stock of any other corporation, or depository receipts in respect thereof, which shares of stock (or depository receipts in respect thereof) or depository receipts at the effective date of the merger or consolidation will be either listed on a national securities exchange or held of record by more than 2,000 holders;

c. Cash in lieu of fractional shares or fractional depository receipts described in the foregoing paragraphs (b)(2)a. and b. of this section; or

d. Any combination of the shares of stock, depository receipts and cash in lieu of fractional shares or fractional depository receipts described in the foregoing paragraphs (b)(2)a., b. and c. of this section.

(3) In the event all of the stock of a subsidiary Delaware corporation party to a merger effected under § 253 or § 267 of this title is not owned by the parent immediately prior to the merger, appraisal rights shall be available for the shares of the subsidiary Delaware corporation.

 

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(4) In the event of an amendment to a corporation’s certificate of incorporation contemplated by § 363(a) of this title, appraisal rights shall be available as contemplated by § 363(b) of this title, and the procedures of this section, including those set forth in subsections (d) and (e) of this section, shall apply as nearly as practicable, with the word “amendment” substituted for the words “merger or consolidation,” and the word “corporation” substituted for the words “constituent corporation” and/or “surviving or resulting corporation.”

(c) Any corporation may provide in its certificate of incorporation that appraisal rights under this section shall be available for the shares of any class or series of its stock as a result of an amendment to its certificate of incorporation, any merger or consolidation in which the corporation is a constituent corporation or the sale of all or substantially all of the assets of the corporation. If the certificate of incorporation contains such a provision, the provisions of this section, including those set forth in subsections (d),(e), and (g) of this section, shall apply as nearly as is practicable.

(d) Appraisal rights shall be perfected as follows:

(1) If a proposed merger or consolidation for which appraisal rights are provided under this section is to be submitted for approval at a meeting of stockholders, the corporation, not less than 20 days prior to the meeting, shall notify each of its stockholders who was such on the record date for notice of such meeting (or such members who received notice in accordance with § 255(c) of this title) with respect to shares for which appraisal rights are available pursuant to subsection (b) or (c) of this section that appraisal rights are available for any or all of the shares of the constituent corporations, and shall include in such notice a copy of this section and, if 1 of the constituent corporations is a nonstock corporation, a copy of § 114 of this title. Each stockholder electing to demand the appraisal of such stockholder’s shares shall deliver to the corporation, before the taking of the vote on the merger or consolidation, a written demand for appraisal of such stockholder’s shares; provided that a demand may be delivered to the corporation by electronic transmission if directed to an information processing system (if any) expressly designated for that purpose in such notice. Such demand will be sufficient if it reasonably informs the corporation of the identity of the stockholder and that the stockholder intends thereby to demand the appraisal of such stockholder’s shares. A proxy or vote against the merger or consolidation shall not constitute such a demand. A stockholder electing to take such action must do so by a separate written demand as herein provided. Within 10 days after the effective date of such merger or consolidation, the surviving or resulting corporation shall notify each stockholder of each constituent corporation who has complied with this subsection and has not voted in favor of or consented to the merger or consolidation of the date that the merger or consolidation has become effective; or

(2) If the merger or consolidation was approved pursuant to § 228, § 251(h), § 253, or § 267 of this title, then either a constituent corporation before the effective date of the merger or consolidation or the surviving or resulting corporation within 10 days thereafter shall notify each of the holders of any class or series of stock of such constituent corporation who are entitled to appraisal rights of the approval of the merger or consolidation and that appraisal rights are available for any or all shares of such class or series of stock of such constituent corporation, and shall include in such notice a copy of this section and, if 1 of the constituent corporations is a nonstock corporation, a copy of § 114 of this title. Such notice may, and, if given on or after the effective date of the merger or consolidation, shall, also notify such stockholders of the effective date of the merger or consolidation. Any stockholder entitled to appraisal rights may, within 20 days after the date of giving such notice or, in the case of a merger approved pursuant to § 251(h) of this title, within the later of the consummation of the offer contemplated by § 251(h) of this title and 20 days after the date of giving such notice, demand in writing from the surviving or resulting corporation the appraisal of such holder’s shares; provided that a demand may be delivered to the corporation by electronic transmission if directed to an information processing system (if any) expressly designated for that purpose in such notice. Such demand will be sufficient if it reasonably informs the corporation of the identity of the stockholder and that the stockholder intends thereby to demand the appraisal of such holder’s shares. If such notice did not notify stockholders of the effective date of the merger or consolidation, either (i) each such constituent corporation shall send a second notice before the effective date of the merger or consolidation notifying each of the holders of any class or series of stock of such constituent

 

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corporation that are entitled to appraisal rights of the effective date of the merger or consolidation or (ii) the surviving or resulting corporation shall send such a second notice to all such holders on or within 10 days after such effective date; provided, however, that if such second notice is sent more than 20 days following the sending of the first notice or, in the case of a merger approved pursuant to § 251(h) of this title, later than the later of the consummation of the offer contemplated by § 251(h) of this title and 20 days following the sending of the first notice, such second notice need only be sent to each stockholder who is entitled to appraisal rights and who has demanded appraisal of such holder’s shares in accordance with this subsection. An affidavit of the secretary or assistant secretary or of the transfer agent of the corporation that is required to give either notice that such notice has been given shall, in the absence of fraud, be prima facie evidence of the facts stated therein. For purposes of determining the stockholders entitled to receive either notice, each constituent corporation may fix, in advance, a record date that shall be not more than 10 days prior to the date the notice is given, provided, that if the notice is given on or after the effective date of the merger or consolidation, the record date shall be such effective date. If no record date is fixed and the notice is given prior to the effective date, the record date shall be the close of business on the day next preceding the day on which the notice is given.

(e) Within 120 days after the effective date of the merger or consolidation, the surviving or resulting corporation or any stockholder who has complied with subsections (a) and (d) of this section hereof and who is otherwise entitled to appraisal rights, may commence an appraisal proceeding by filing a petition in the Court of Chancery demanding a determination of the value of the stock of all such stockholders. Notwithstanding the foregoing, at any time within 60 days after the effective date of the merger or consolidation, any stockholder who has not commenced an appraisal proceeding or joined that proceeding as a named party shall have the right to withdraw such stockholder’s demand for appraisal and to accept the terms offered upon the merger or consolidation. Within 120 days after the effective date of the merger or consolidation, any stockholder who has complied with the requirements of subsections (a) and (d) of this section hereof, upon request given in writing (or by electronic transmission directed to an information processing system (if any) expressly designated for that purpose in the notice of appraisal), shall be entitled to receive from the corporation surviving the merger or resulting from the consolidation a statement setting forth the aggregate number of shares not voted in favor of the merger or consolidation (or, in the case of a merger approved pursuant to § 251(h) of this title, the aggregate number of shares (other than any excluded stock (as defined in § 251(h)(6)d. of this title)) that were the subject of, and were not tendered into, and accepted for purchase or exchange in, the offer referred to in § 251(h)(2)), and, in either case, with respect to which demands for appraisal have been received and the aggregate number of holders of such shares. Such statement shall be given to the stockholder within 10 days after such stockholder’s request for such a statement is received by the surviving or resulting corporation or within 10 days after expiration of the period for delivery of demands for appraisal under subsection (d) of this section hereof, whichever is later. Notwithstanding subsection (a) of this section, a person who is the beneficial owner of shares of such stock held either in a voting trust or by a nominee on behalf of such person may, in such person’s own name, file a petition or request from the corporation the statement described in this subsection.

(f) Upon the filing of any such petition by a stockholder, service of a copy thereof shall be made upon the surviving or resulting corporation, which shall within 20 days after such service file in the office of the Register in Chancery in which the petition was filed a duly verified list containing the names and addresses of all stockholders who have demanded payment for their shares and with whom agreements as to the value of their shares have not been reached by the surviving or resulting corporation. If the petition shall be filed by the surviving or resulting corporation, the petition shall be accompanied by such a duly verified list. The Register in Chancery, if so ordered by the Court, shall give notice of the time and place fixed for the hearing of such petition by registered or certified mail to the surviving or resulting corporation and to the stockholders shown on the list at the addresses therein stated. Such notice shall also be given by 1 or more publications at least 1 week before the day of the hearing, in a newspaper of general circulation published in the City of Wilmington, Delaware or such publication as the Court deems advisable. The forms of the notices by mail and by publication shall be approved by the Court, and the costs thereof shall be borne by the surviving or resulting corporation.

 

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(g) At the hearing on such petition, the Court shall determine the stockholders who have complied with this section and who have become entitled to appraisal rights. The Court may require the stockholders who have demanded an appraisal for their shares and who hold stock represented by certificates to submit their certificates of stock to the Register in Chancery for notation thereon of the pendency of the appraisal proceedings; and if any stockholder fails to comply with such direction, the Court may dismiss the proceedings as to such stockholder. If immediately before the merger or consolidation the shares of the class or series of stock of the constituent corporation as to which appraisal rights are available were listed on a national securities exchange, the Court shall dismiss the proceedings as to all holders of such shares who are otherwise entitled to appraisal rights unless (1) the total number of shares entitled to appraisal exceeds 1% of the outstanding shares of the class or series eligible for appraisal, (2) the value of the consideration provided in the merger or consolidation for such total number of shares exceeds $1 million, or (3) the merger was approved pursuant to § 253 or § 267 of this title.

(h) After the Court determines the stockholders entitled to an appraisal, the appraisal proceeding shall be conducted in accordance with the rules of the Court of Chancery, including any rules specifically governing appraisal proceedings. Through such proceeding the Court shall determine the fair value of the shares exclusive of any element of value arising from the accomplishment or expectation of the merger or consolidation, together with interest, if any, to be paid upon the amount determined to be the fair value. In determining such fair value, the Court shall take into account all relevant factors. Unless the Court in its discretion determines otherwise for good cause shown, and except as provided in this subsection, interest from the effective date of the merger through the date of payment of the judgment shall be compounded quarterly and shall accrue at 5% over the Federal Reserve discount rate (including any surcharge) as established from time to time during the period between the effective date of the merger and the date of payment of the judgment. At any time before the entry of judgment in the proceedings, the surviving corporation may pay to each stockholder entitled to appraisal an amount in cash, in which case interest shall accrue thereafter as provided herein only upon the sum of (1) the difference, if any, between the amount so paid and the fair value of the shares as determined by the Court, and (2) interest theretofore accrued, unless paid at that time. Upon application by the surviving or resulting corporation or by any stockholder entitled to participate in the appraisal proceeding, the Court may, in its discretion, proceed to trial upon the appraisal prior to the final determination of the stockholders entitled to an appraisal. Any stockholder whose name appears on the list filed by the surviving or resulting corporation pursuant to subsection (f) of this section and who has submitted such stockholder’s certificates of stock to the Register in Chancery, if such is required, may participate fully in all proceedings until it is finally determined that such stockholder is not entitled to appraisal rights under this section.

(i) The Court shall direct the payment of the fair value of the shares, together with interest, if any, by the surviving or resulting corporation to the stockholders entitled thereto. Payment shall be so made to each such stockholder, in the case of holders of uncertificated stock forthwith, and the case of holders of shares represented by certificates upon the surrender to the corporation of the certificates representing such stock. The Court’s decree may be enforced as other decrees in the Court of Chancery may be enforced, whether such surviving or resulting corporation be a corporation of this State or of any state.

(j) The costs of the proceeding may be determined by the Court and taxed upon the parties as the Court deems equitable in the circumstances. Upon application of a stockholder, the Court may order all or a portion of the expenses incurred by any stockholder in connection with the appraisal proceeding, including, without limitation, reasonable attorney’s fees and the fees and expenses of experts, to be charged pro rata against the value of all the shares entitled to an appraisal.

(k) From and after the effective date of the merger or consolidation, no stockholder who has demanded appraisal rights as provided in subsection (d) of this section shall be entitled to vote such stock for any purpose or to receive payment of dividends or other distributions on the stock (except dividends or other distributions payable to stockholders of record at a date which is prior to the effective date of the merger or consolidation); provided, however, that if no petition for an appraisal shall be filed within the time provided in subsection (e) of this section, or if such stockholder shall deliver to the surviving or resulting corporation a written withdrawal of

 

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such stockholder’s demand for an appraisal and an acceptance of the merger or consolidation, either within 60 days after the effective date of the merger or consolidation as provided in subsection (e) of this section or thereafter with the written approval of the corporation, then the right of such stockholder to an appraisal shall cease. Notwithstanding the foregoing, no appraisal proceeding in the Court of Chancery shall be dismissed as to any stockholder without the approval of the Court, and such approval may be conditioned upon such terms as the Court deems just; provided, however that this provision shall not affect the right of any stockholder who has not commenced an appraisal proceeding or joined that proceeding as a named party to withdraw such stockholder’s demand for appraisal and to accept the terms offered upon the merger or consolidation within 60 days after the effective date of the merger or consolidation, as set forth in subsection (e) of this section.

(l) The shares of the surviving or resulting corporation to which the shares of such objecting stockholders would have been converted had they assented to the merger or consolidation shall have the status of authorized and unissued shares of the surviving or resulting corporation.

 

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PART II

INFORMATION NOT REQUIRED IN PROXY

STATEMENT/PROSPECTUS

 

Item 20.

Indemnification of Directors and Officers

Subsection (a) of Section 145 of the DGCL empowers a corporation to indemnify any person who was or is a party or who is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of the corporation) by reason of the fact that the person is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by the person in connection with such action, suit or proceeding if the person acted in good faith and in a manner the person reasonably believed to be in or not opposed to the best interests of the corporation, and, with respect to any criminal action or proceeding, had no reasonable cause to believe the person’s conduct was unlawful.

Subsection (b) of Section 145 empowers a corporation to indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action or suit by or in the right of the corporation to procure a judgment in its favor by reason of the fact that the person acted in any of the capacities set forth above, against expenses (including attorneys’ fees) actually and reasonably incurred by the person in connection with the defense or settlement of such action or suit if the person acted in good faith and in a manner the person reasonably believed to be in or not opposed to the best interests of the corporation, except that no indemnification shall be made in respect of any claim, issue or matter as to which such person shall have been adjudged to be liable to the corporation unless and only to the extent that the Court of Chancery or the court in which such action or suit was brought shall determine upon application that, despite the adjudication of liability but in view of all the circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expenses which the Court of Chancery or such other court shall deem proper.

Section 145 further provides that to the extent a director or officer of a corporation has been successful on the merits or otherwise in the defense of any action, suit or proceeding referred to in subsections (a) and (b) of Section 145, or in defense of any claim, issue or matter therein, such person shall be indemnified against expenses (including attorneys’ fees) actually and reasonably incurred by such person in connection therewith; that indemnification provided for by Section 145 shall not be deemed exclusive of any other rights to which the indemnified party may be entitled; and the indemnification provided for by Section 145 shall, unless otherwise provided when authorized or ratified, continue as to a person who has ceased to be a director, officer, employee or agent and shall inure to the benefit of such person’s heirs, executors and administrators. Section 145 also empowers the corporation to purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise against any liability asserted against such person and incurred by such person in any such capacity, or arising out of his status as such, whether or not the corporation would have the power to indemnify such person against such liabilities under Section 145.

Section 102(b)(7) of the DGCL provides that a corporation’s certificate of incorporation may contain a provision eliminating or limiting the personal liability of a director to the corporation or its stockholders for monetary damages for breach of fiduciary duty as a director, provided that such provision shall not eliminate or limit the liability of a director (i) for any breach of the director’s duty of loyalty to the corporation or its stockholders, (ii) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law, (iii) under Section 174 of the DGCL, or (iv) for any transaction from which the director derived an improper personal benefit.

 

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Homology’s Restated Certificate of Incorporation contains provisions that eliminate, to the maximum extent permitted by the DGCL, the personal liability of directors and executive officers for monetary damages for breach of their fiduciary duties as a director or officer. Homology’s Restated Certificate of Incorporation and Amended and Restated Bylaws provide that Homology shall indemnify its directors and officers and may indemnify its employees and other agents to the fullest extent permitted by the DGCL. However, the DGCL prohibits Homology from limiting the liability of directors for (i) any breach of a director’s duty of loyalty to Homology or to Homology’s stockholders,(ii) acts or omissions not in good faith or that involve intentional misconduct or a knowing violation of law, unlawful payment of dividends or unlawful stock repurchases or redemptions, and (iv) any transaction from which a director derived an improper personal benefit.

If Delaware law is amended to authorize corporate action further eliminating or limiting the personal liability of a director, then the liability of Homology’s directors will be eliminated or limited to the fullest extent permitted by Delaware law, as so amended. Homology’s Restated Certificate of Incorporation does not eliminate a director’s duty of care and, in appropriate circumstances, equitable remedies, such as injunctive or other forms of nonmonetary relief, remain available under Delaware law. It also does not affect a director’s responsibilities under any other laws, such as the federal securities laws or other state or federal laws. Under Homology’s Amended and Restated Bylaws, Homology will also be empowered to enter into indemnification agreements with its directors, officers, employees and other agents and to purchase insurance on behalf of any person whom Homology is required or permitted to indemnify.

Homology entered into indemnification agreements with its directors and executive officers, in addition to the indemnification provided for in its Restated Certificate of Incorporation and Amended and Restated Bylaws, and intends to enter into indemnification agreements with any new directors and executive officers in the future. These agreements provide for the indemnification of such persons for all reasonable expenses and liabilities incurred in connection with any action or proceeding brought against them by reason of the fact that they are or were serving in such capacity. Homology believes that these Restated Certificate of Incorporation and Amended and Restated Bylaws provisions and indemnification agreements are necessary to attract and retain qualified persons as directors, officers and employees.

Homology has purchased and intends to maintain insurance on behalf of any person who is or was a director or officer of Homology against any loss arising from any claim asserted against him or her and incurred by him or her in any such capacity, subject to certain exclusions.

The limitation of liability and indemnification provisions in Homology’s Restated Certificate of Incorporation and Amended and Restated Bylaws may discourage stockholders from bringing a lawsuit against directors for breach of their fiduciary duties. They may also reduce the likelihood of derivative litigation against directors and officers, even though an action, if successful, might benefit Homology and its stockholders. A stockholder’s investment may be harmed to the extent Homology pays the costs of settlement and damage awards against directors and officers pursuant to these indemnification provisions. Insofar as indemnification for liabilities arising under the Securities Act, may be permitted to Homology’s directors, officers and controlling persons pursuant to the foregoing provisions, or otherwise, Homology has been advised that, in the opinion of the SEC, such indemnification is against public policy as expressed in the Securities Act, and is, therefore, unenforceable. There is no pending litigation or proceeding naming any of Homology’s directors or officers as to which indemnification is being sought, nor is Homology aware of any pending or threatened litigation that may result in claims for indemnification by any director or officer.

Under the Merger Agreement, from the closing of the Merger through the sixth anniversary of the closing, Homology and the surviving corporation agree that all rights to indemnification, exculpation or advancement of expenses now existing in favor of, and all limitations on the personal liability of, each present and former director or officer, of Homology or Q32 provided for in the respective organizational documents of Homology and Q32 in effect as of November 16, 2023, the date of the Merger Agreement, shall continue to be honored and in full force and effect.

 

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Under the Merger Agreement, the Restated Certificate of Incorporation and Homology Amended and Restated Bylaws and the surviving corporation in the Merger, will contain provisions no less favorable with respect to indemnification, advancement of expenses and exculpation of present and former directors and officers of Homology than are presently set forth in the Restated Certificate of Incorporation and Homology Amended and Restated Bylaws, which provisions shall not be amended, modified or repealed for a period of six years’ time from the closing of the Merger in a manner that would materially and adversely affect the rights thereunder of individuals who, at or prior to the closing, were officers or directors of Homology.

The Merger Agreement also provides that Homology shall purchase an insurance policy in effect for six years from the closing, providing at least the same coverage as the current directors’ and officers’ liability insurance policies maintained by Homology and containing terms and conditions that are not materially less favorable to current and former officers and directors of Homology.

 

Item 21.

Exhibits and Financial Statement Schedules

(a) Exhibit Index

 

         Incorporated by Reference (if applicable)  

Exhibit
Number

  

Exhibit Description

 

Form

   

File No.

   

Exhibit

   

Filing Date

 
  2.1*    Agreement and Plan of Merger, dated as of November 16, 2023, by and among Homology Medicines, Inc., Kenobi Merger Sub, Inc., and Q32 Bio Inc.        
  3.1    Restated Certificate of Incorporation of Homology Medicines, Inc.     8-K       001-38433       3.1       4/3/2018  
  3.2    Amended and Restated Bylaws of Homology Medicines, Inc.     8-K       001-38433       3.1       12/18/2020  
  4.1    Specimen Stock Certificate evidencing the shares of common stock.     S-1/A       333-223409       4.2       3/19/2018  
  4.2    Description of Securities.     10-K       001-38433       4.3       3/9/2023  
  5.1**    Opinion of Latham & Watkins LLP.        
10.1    Form of Support Agreement by and between Homology Medicines, Inc. and certain stockholders of Q32 Bio Inc.        
10.2    Form of Support Agreement by and between Q32 Bio Inc. and certain stockholders of Homology Medicines, Inc.        
10.3    Form of Lock-Up Agreement by and between Q32 Bio Inc. and directors, officers and certain stockholders of Q32 Bio Inc.     8-K       001-38433       10.3       11/16/2023  
10.4    Form of Lock-Up Agreement by and between Q32 Bio Inc. and certain directors of Homology Medicines, Inc.     8-K       001-38433       10.4       11/16/2023  
10.5    Form of CVR Agreement.        
10.6    Amendment to Amended and Restated Employment Agreement, dated November 16, 2023, by and between Homology Medicines, Inc. and Albert Seymour, Ph.D.     8-K       001-38433       10.6       11/16/2023  
10.7    Second Amendment to Employment Agreement, dated November 16, 2023, by and between Homology Medicines, Inc. and W. Bradford Smith     8-K       001-38433       10.7       11/16/2023  

 

II-3


Table of Contents
         Incorporated by Reference (if applicable)  

Exhibit
Number

  

Exhibit Description

 

Form

   

File No.

   

Exhibit

   

Filing Date

 
10.8    Amended and Restated Employment Agreement, dated November 16, 2023, by and between Homology Medicines, Inc. and Paul Alloway, Ph.D.        
10.9    Employment Agreement, dated November 16, 2023, by and between Homology Medicines, Inc. and Charles Michaud, Jr.        
10.10    Consulting Agreement, dated November 17, 2023, by and between Homology Medicines, Inc. and W. Bradford Smith        
10.11+    2015 Stock Incentive Plan, as amended, and forms of agreements thereunder.     S-1/A       333-223409       10.1       3/19/2018  
10.12+    2018 Incentive Award Plan, and forms of awards thereunder.     10-K       001-38433       10.2       3/11/2021  
10.13+    Non-Employee Director Compensation Program.     10-Q       001-38433       10.1       11/10/2022  
10.14    Form of Indemnification Agreement for Directors and Officers.     S-1/A       333-223409       10.5       3/19/2018  
10.15+    2018 Employee Stock Purchase Plan.     S-1/A       333-223409       10.3       3/19/2018  
10.16+    2018 Employee Stock Purchase Plan – Offering Document.     10-Q       001-38433       10.1       11/13/2018  
10.17    Lease Agreement, dated December 21, 2017, by and between Homology Medicines, Inc. and Patriots Park Owner, LLC, as amended by the First Amendment to Lease, dated February 8, 2019, the Second Amendment to Lease, dated March 15, 2019, and the Third Amendment to Lease, dated November 9, 2021.     10-Q       001-38433       10.1       11/15/2021  
10.18    Assignment and Assumption Agreement, dated March 10, 2022, between Homology Medicines, Inc. and Roadrunner Solutions LLC.     10-K       001-38433       10.8       3/23/2022  
10.19    Sublease Agreement, dated March 10, 2022, between Homology Medicines, Inc. and Roadrunner Solutions LLC.     10-K       001-38433       10.9       3/23/2022  
10.20+    Amended and Restated Employment Agreement, dated April 21, 2022, by and between Homology Medicines, Inc. and Albert Seymour, Ph.D.     8-K       001-38433       10.1       4/21/2022  
10.21+    Employment Agreement, dated March 18, 2018, by and between Homology Medicines, Inc. and W. Bradford Smith.     S-1/A       333-223409       10.13       3/19/2018  
10.22+    Amendment to Employment Agreement, dated as of September 6, 2022, by and between Homology Medicines, Inc. and W. Bradford Smith.     8-K       001-38433       10.2       9/8/2022  
10.23+    Consulting Agreement, dated as of September 6, 2022, by and between Homology Medicines, Inc. and Arthur Tzianabos, Ph.D.     8-K       001-38433       10.1       9/8/2022  

 

II-4


Table of Contents
         Incorporated by Reference (if applicable)  

Exhibit
Number

  

Exhibit Description

 

Form

   

File No.

   

Exhibit

   

Filing Date

 
10.24    Exclusive License Agreement, dated April 28, 2016, between Homology Medicines, Inc. and City of Hope.     S-1/A       333-223409       10.16       3/19/2018  
10.25    Stock Purchase Agreement, dated November 9, 2020, by and between Homology Medicines, Inc. and Pfizer Inc.     8-K       001-38433       10.1       11/9/2020  
10.26    Equity Securities Purchase Agreement, dated January 28, 2022, by and among Homology Medicines, Inc., Roadrunner Solutions LLC, Oxford Biomedica (US), Inc. and, solely for purposes of Article IX thereof, Oxford Biomedica plc.     10-K       001-38433       10.23       3/23/2022  
10.27    Amendment No. 1, dated as of March 10, 2022, to Equity Securities Purchase Agreement, dated as of January 28, 2022, by and among Homology Medicines, Inc., Roadrunner Solutions LLC, Oxford Biomedica (US), Inc. and, solely for purposes of Article IX thereof, Oxford Biomedica plc.     10-K       001-38433       10.24       3/23/2022  
10.28    Contribution Agreement, dated March 10, 2022, between Homology Medicines, Inc. and Roadrunner Solutions LLC.     10-K       001-38433       10.25       3/23/2022  
10.29    Amended and Restated Limited Liability Company Agreement, dated March 10, 2022, by and among Oxford Biomedica Solutions LLC (f/k/a Roadrunner Solutions LLC), Homology Medicines, Inc. and Oxford Biomedica (US) Inc.     10-K       001-38433       10.26       3/23/2022  
10.30    Manufacturing and Supply Agreement, dated March 10, 2022, by and among Homology Medicines, Inc., Roadrunner Solutions LLC and, solely for purposes of Section 2.3(b)(iii) thereof, Oxford Biomedica UK Limited.     10-K       001-38433       10.27       3/23/2022  
10.36*†    Asset Purchase Agreement, dated August 12, 2022, by and between Q32 Bio Inc. and Horizon Therapeutics Ireland DAC.        
10.37*†    Collaboration and Option Agreement, dated August 12, 2022, by and between Q32 Bio Inc. and Horizon Therapeutics Ireland DAC.        
10.38†    Termination Agreement, dated November 10, 2023, between Q32 Bio Inc. and Horizon Therapeutics DAC.        
10.39*†    Exclusive License Agreement, dated August 9, 2017, between Q32 Bio Inc. and The Regents of the University of Colorado.        
10.40†    First Amendment to the Exclusive License Agreement, dated February 8, 2017, between Q32 Bio Inc. and The Regents of the University of Colorado.        
10.41†    Second Amendment to the Exclusive License Agreement, dated September 27, 2018, between Q32 Bio Inc. and The Regents of the University of Colorado.        

 

II-5


Table of Contents
         Incorporated by Reference (if applicable)  

Exhibit
Number

  

Exhibit Description

 

Form

   

File No.

   

Exhibit

   

Filing Date

 
10.42†    Third Amendment to the Exclusive License Agreement, dated April 9, 2019, between Q32 Bio Inc. and The Regents of the University of Colorado.        
10.43*†    License Agreement, dated as of September 14, 2019, between Q32 Bio Inc. and Bristol-Myers Squibb Company.        
10.44†    First Amendment to License Agreement, dated as of August 13, 2021, between Q32 Bio Inc. and Bristol-Myers Squibb Company.        
10.45    Second Amendment to License Agreement, dated as of July 26, 2022, between Q32 Bio Inc. and Bristol-Myers Squibb Company.        
10.46†    Third Amendment to License Agreement, dated as of July 26, 2022, between Q32 Bio Inc. and Bristol-Myers Squibb Company.        
10.47*    Lease Agreement, dated March 20, 2021, by and between Q32 Bio Inc. and PPF OFF 828-830 WINTER STREET LLC.        
10.48*    Note Purchase Agreement, dated May 20, 2022, by and between Q32 Bio Inc. and the individuals and entities party thereto.        
10.49*   

Amendment No. 1 to Note Purchase Agreement, dated May 20, 2022, by and between Q32 Bio Inc. and the individuals and entities party thereto.

       
10.50*    Loan and Security Agreement, dated as of December 11, 2020, by and between Q32 Bio Inc. and Silicon Valley Bank, as amended.        
10.51    First Amendment to Loan and Security Agreement, dated December 30, 2021, by and between Q32 Bio Inc. and Silicon Valley Bank.        
10.52    Second Amendment to Loan and Security Agreement, dated June 30, 2022, by and between Q32 Bio Inc. and Silicon Valley Bank.        
10.53*    Third Amendment to Loan and Security Agreement, dated August 10, 2022, by and between Q32 Bio Inc. and Silicon Valley Bank.        
10.54*    Fourth Amendment to Loan and Security Agreement, dated December 21, 2022, by and between Q32 Bio Inc. and Silicon Valley Bank.        
10.55*    Fifth Amendment to Loan and Security Agreement, dated April 26, 2023, by and between Q32 Bio Inc. and Silicon Valley Bank.        

 

II-6


Table of Contents
         Incorporated by Reference (if applicable)  

Exhibit
Number

  

Exhibit Description

 

Form

   

File No.

   

Exhibit

   

Filing Date

 
10.56*    Sixth Amendment to Loan and Security Agreement, dated July12, 2023, by and between Q32 Bio Inc. and Silicon Valley Bank.        
10.57    Seventh Amendment to Loan and Security Agreement, dated November 2, 2023, by and between Q32 Bio Inc. and Silicon Valley Bank.        
10.58†    Q32 Bio Inc. 2017 Stock Option and Grant Plan        
10.59†**    Q32 Bio Inc. 2024 Stock Option and Incentive Plan        
10.60†**    Q32 Bio Inc. 2024 Employee Stock Purchase Plan        
21.1    Subsidiaries of Homology Medicines, Inc.     S-1       333-223409       21.1       3/2/2018  
23.1    Consent of Deloitte & Touche LLP, Independent Registered Public Accounting Firm.        
23.2    Consent of Ernst & Young LLP, Independent Registered Public Accounting Firm.        
24.1    Power of Attorney (included on signature page to registration statement).        
99.1    Form of Proxy Card.        
99.2**    Consent of Latham & Watkins LLP (included in Exhibit 5.1).        
99.3    Consent of Cowen and Company, LLC.        
99.4    Consent of Jodie Morrison to be named as a director.        
107    Filing Fee Table.        
101.INS    XBRL Instance Document.        
101.SCH    XBRL Taxonomy Extension Schema Document.        
101.CAL    XBRL Taxonomy Extension Calculation Linkbase Document.        
101.DEF    XBRL Taxonomy Extension Definitions Linkbase Document.        
101.LAB    XBRL Taxonomy Extension Label Linkbase Document.        
101.PRE    XBRL Taxonomy Extension Presentation Linkbase Document.        

 

*

Annexes, schedules and exhibits have been omitted pursuant to Item 601(b)(2) or 601(a)(5), as applicable, of Regulation S-K. The registrant agrees to furnish supplementally a copy of any omitted attachment to the SEC on a confidential basis upon request.

**

To be filed by amendment.

+

Indicates management contract or compensatory plan.

†

Certain confidential portions of this Exhibit were omitted by means of marking such portions with brackets (“[***]”) because the identified confidential portions (i) are not material and (ii) is the type of information that the registrant treats as private or confidential.

 

II-7


Table of Contents

(b) Financial Statements

The financial statements filed with this registration statement on Form S-4 are set forth on the Financial Statement Index and is incorporated herein by reference.

 

Item 22.

Undertakings

(a) The undersigned registrant hereby undertakes as follows:

(1) To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:

(i) to include any prospectus required by Section 10(a)(3) of the Securities Act;

(ii) to reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the SEC pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the “Calculation of Filing Fee Tables” in the effective registration statement.

(iii) To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement.

(2) That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

(3) To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.

(4) That, for purposes of determining liability under the Securities Act, each filing of the registrant’s annual report pursuant to Section 13(a) or 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Exchange Act) that is provided in this proxy statement/prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

(5) That prior to any public reoffering of the securities registered hereunder through use of a prospectus which is a part of this registration statement, by any person or party who is deemed to be an underwriter within the meaning of Rule 145(c), the issuer undertakes that such reoffering prospectus will contain the information called for by the applicable registration form with respect to reofferings by persons who may be deemed underwriters, in addition to the information called for by the other items of the applicable form.

(6) That every prospectus (i) that is filed pursuant to paragraph (a)(5) immediately preceding, or (ii) that purports to meet the requirements of Section 10(a)(3) of the Securities Act and is used in connection with an offering of securities subject to Rule 415, will be filed as a part of an amendment to the registration statement and will not be used until such amendment is effective, and that, for purposes of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

 

II-8


Table of Contents

(7) To respond to requests for information that is provided in this proxy statement/prospectus pursuant to Item 4, 10(b), 11, or 13 of Form S-4, within one business day of receipt of such request, and to send the incorporated documents by first class mail or other equally prompt means. This includes information contained in documents filed subsequent to the effective date of the registration statement through the date of responding to the request.

(8) To supply by means of a post-effective amendment all information concerning a transaction, and the company being acquired involved therein, that was not the subject of and included in the registration statement when it became effective.

(b) Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers, or persons controlling the registrant pursuant to the foregoing provisions the registrant has been informed that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

 

II-9


Table of Contents

SIGNATURES

Pursuant to the requirements of the Securities Act, the registrant has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Bedford, Commonwealth of Massachusetts, on the 15th day of December 2023.

 

Homology Medicines, Inc.
By:  

/s/ Paul Alloway, Ph.D.

Name:   Paul Alloway, Ph.D.
Title:   President and Chief Operating Officer

POWER OF ATTORNEY

We, the undersigned directors and officers of Homology Medicines, Inc. hereby severally constitute and appoint Paul Alloway, Ph.D. and Charles Michaud, Jr., each acting together or alone, his or her true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for such person and in his or her name, place and stead, in any and all capacities, to sign this Registration Statement on Form S-4 (including all pre-effective and post-effective amendments and registration statements filed pursuant to Rule 462 under the Securities Act), and to file the same, with all exhibits thereto, and other documents in connection therewith, with the SEC, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming that such attorney-in-fact and agent, or his or her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Act, this Registration Statement has been signed by the following persons in the capacities and on the dates indicated.

 

Signature

  

Title

 

Date

/s/ Paul Alloway, Ph.D.

Paul Alloway, Ph.D.

   President, Chief Operating Officer and Secretary (Principal Executive Officer)   December 15, 2023

/s/ Charles Michaud, Jr.

Charles Michaud, Jr.

   Vice President, Corporate Controller and Treasurer (Principal Financial and Accounting Officer)   December 15, 2023

/s/ Arthur O. Tzianabos, Ph.D.

Arthur O. Tzianabos, Ph.D.

   Chairman of the Board of Directors   December 15, 2023

/s/ Jeffrey V. Poulton

Jeffrey V. Poulton

   Lead Independent Director   December 15, 2023

/s/ Steven Gillis, Ph.D.

Steven Gillis, Ph.D.

   Director   December 15, 2023

/s/ Matthew R. Patterson

Matthew R. Patterson

   Director   December 15, 2023

/s/ Alise S. Reicin, M.D.

Alise S. Reicin, M.D.

   Director   December 15, 2023

/s/ Mary Thistle

Mary Thistle

   Director   December 15, 2023

 

1

Exhibit 2.1

Execution Version

 

AGREEMENT AND PLAN OF MERGER

by and among:

HOMOLOGY MEDICINES, INC.;

KENOBI MERGER SUB, INC.;

and

Q32 BIO INC.

Dated as of November 16, 2023


TABLE OF CONTENTS

 

               Page  

ARTICLE I DEFINITIONS AND INTERPRETATIVE PROVISIONS

     2  
   1.1    Definitions      2  
   1.2    Other Definitional and Interpretative Provisions      16  

ARTICLE II THE MERGER

     17  
   2.1    The Merger      17  
   2.2    Closing      17  
   2.3    Organizational Documents; Directors and Officers      17  
   2.4    Conversion of Shares      17  
   2.5    Contingent Value Right.      19  
   2.6    Closing of Q32’s Transfer Books      20  
   2.7    Surrender of Q32 Common Stock      20  
   2.8    Calculation of Net Cash      20  
   2.9    Further Action      22  
   2.10    Withholding      22  

ARTICLE III REPRESENTATIONS AND WARRANTIES OF Q32

     22  
   3.1    Due Organization; Subsidiaries      22  
   3.2    Organizational Documents      23  
   3.3    Authority; Binding Nature of Agreement      23  
   3.4    Vote Required      23  
   3.5    Non-Contravention; Consents      23  
   3.6    Capitalization      24  
   3.7    Financial Statements      25  
   3.8    Absence of Changes      26  
   3.9    Absence of Undisclosed Liabilities      26  
   3.10    Title to Assets      26  
   3.11    Real Property; Leasehold      26  
   3.12    Intellectual Property      26  
   3.13    Agreements, Contracts and Commitments      30  
   3.14    Compliance; Permits; Restrictions      32  
   3.15    Legal Proceedings; Orders      33  
   3.16    Tax Matters      33  
   3.17    Employee and Labor Matters; Benefit Plans      35  
   3.18    Environmental Matters      37  
   3.19    Insurance      37  
   3.20    Transactions with Affiliates      37  
   3.21    No Financial Advisors      37  
   3.22    Privacy and Data Security      38  
   3.23    Concurrent Financing      38  
   3.24    No Other Representations or Warranties      39  

ARTICLE IV REPRESENTATIONS AND WARRANTIES OF HOMOLOGY AND MERGER SUB

     39  
   4.1    Due Organization; Subsidiaries      39  
   4.2    Organizational Documents      40  
   4.3    Authority; Binding Nature of Agreement      40  
   4.4    Vote Required      40  
   4.5    Non-Contravention; Consents      40  

 

i


   4.6    Capitalization      41  
   4.7    SEC Filings; Financial Statements      42  
   4.8    Absence of Changes      44  
   4.9    Absence of Undisclosed Liabilities      44  
   4.10    Title to Assets      44  
   4.11    Real Property; Leasehold      44  
   4.12    Intellectual Property      44  
   4.13    Agreements      48  
   4.14    Compliance; Permits; Restrictions      50  
   4.15    Legal Proceedings; Orders      51  
   4.16    Tax Matters      52  
   4.17    Employee and Labor Matters; Benefit Plans      53  
   4.18    Environmental Matters      55  
   4.19    Insurance      55  
   4.20    Transactions with Affiliates      56  
   4.21    No Financial Advisors      56  
   4.22    Valid Issuance; No Bad Actor      56  
   4.23    Privacy and Data Security      56  
   4.24    No Other Representations or Warranties      57  

ARTICLE V COVENANTS

     57  
   5.1    Conduct of Q32’s Business      57  
   5.2    Conduct of Homology’s Business      58  
   5.3    Access and Investigation.      60  
   5.4    No Solicitation.      61  
   5.5    Notification of Certain Matters      62  
   5.6    Legacy Asset Disposition      62  
   5.7    Registration Statement; Proxy Statement      63  
   5.8    Q32 Stockholder Written Consent.      64  
   5.9    Homology Stockholder Meeting.      65  
   5.10    Efforts; Regulatory Approvals.      66  
   5.11    Disclosures      67  
   5.12    Homology Options      67  
   5.13    Homology Restricted Stock Unit Awards      67  
   5.14    Homology ESPP      67  
   5.15    Indemnification of Officers and Directors      68  
   5.16    Tax Matters      69  
   5.17    Listing      70  
   5.18    Legends      70  
   5.19    Officers and Directors      70  
   5.20    Termination of Certain Agreements and Rights      71  
   5.21    Section 16 Matters      71  
   5.22    Allocation Certificate      71  
   5.23    Nasdaq Reverse Split      71  
   5.24    Obligations of Merger Sub      71  
   5.25    Takeover Statutes      71  
   5.26    Stockholder Litigation      71  
   5.27    Concurrent Financing      72  
   5.28    Homology Equity Plans      72  
   5.29    Homology 401(k) Plan      73  

 

ii


ARTICLE VI CONDITIONS TO CONSUMMATION OF THE MERGER

     73  
   6.1    Conditions Precedent to Obligations of Each Party      73  
   6.2    Conditions Precedent to Obligations of Q32      74  
   6.3    Conditions Precedent to Obligations of      74  
   6.4    Frustration of Closing Conditions      75  

ARTICLE VII CLOSING DELIVERIES

     75  
   7.1    Closing Deliveries of Q32      75  
   7.2    Closing Deliveries of Homology      75  

ARTICLE VIII TERMINATION

     76  
   8.1    Termination      76  
   8.2    Effect of Termination      77  
   8.3    Expenses; Termination Fees.      77  

ARTICLE IX GENERAL PROVISIONS

     78  
   9.1    Non-Survival of Representations and Warranties      78  
   9.2    Amendment      78  
   9.3    Waiver      78  
   9.4    Entire Agreement; Counterparts; Exchanges by Electronic Transmission or Facsimile      79  
   9.5    Applicable Law; Jurisdiction      79  
   9.6    Assignability      79  
   9.7    Notices      79  
   9.8    Cooperation      80  
   9.9    Severability      80  
   9.10    Other Remedies; Specific Performance      80  
   9.11    No Third-Party Beneficiaries      81  

EXHIBITS

 

Exhibit A    Form of Homology Stockholder Support Agreement
Exhibit B    Form of Q32 Stockholder Support Agreement
Exhibit C    Form of Homology Lock-Up Agreement
Exhibit D    Form of Q32 Lock-Up Agreement
Exhibit E    Form of CVR Agreement

 

iii


AGREEMENT AND PLAN OF MERGER

THIS AGREEMENT AND PLAN OF MERGER (this “Agreement”) is made and entered into as of November 16, 2023, by and among HOMOLOGY MEDICINES, INC., a Delaware corporation (“Homology”), KENOBI MERGER SUB, INC., a Delaware corporation and a direct, wholly owned subsidiary of Homology (“Merger Sub”), and Q32 BIO INC., a Delaware corporation (“Q32”). Certain capitalized terms used in this Agreement are defined in Section 1.1.

RECITALS

A. Homology and Q32 intend to effect a merger of Merger Sub with and into Q32 (the “Merger”) in accordance with this Agreement and Delaware Law. Upon consummation of the Merger, Merger Sub will cease to exist and Q32 will become a wholly owned subsidiary of Homology.

B. The board of directors of Homology (the “Homology Board”) has (i) determined that the Contemplated Transactions are fair to, advisable and in the best interests of Homology and its stockholders, (ii) approved and declared advisable this Agreement and the Contemplated Transactions, including the issuance of shares of Homology Common Stock to the stockholders of Q32 pursuant to the terms of this Agreement, the change of control of Homology and the other actions contemplated by this Agreement, and (iii) determined to recommend, upon the terms and subject to the conditions set forth in this Agreement, that the stockholders of Homology vote to (a) approve the issuance of Homology Common Stock in the Merger and the change of control resulting from the Merger in accordance with Nasdaq Listing Rule 5635 (the “Nasdaq Issuance Proposal”), (b) approve an amendment to Homology’s certificate of incorporation to increase the number of authorized shares from 200,000,000 shares of Homology Common Stock to 400,000,000 shares of Homology Common Stock (the “Authorized Share Increase Proposal”) and (c) approve an amendment to Homology’s certificate of incorporation to effect the Nasdaq Reverse Split (the “Reverse Stock Split Proposal” and, together with the Authorized Share Increase Proposal, the “Charter Amendment Proposals”).

C. The board of directors of Merger Sub (the “Merger Sub Board”) has (i) determined that the Contemplated Transactions are fair to, advisable, and in the best interests of Merger Sub and its sole stockholder, (ii) approved and declared advisable this Agreement and the Contemplated Transactions and (iii) determined to recommend, upon the terms and subject to the conditions set forth in this Agreement, that the stockholder of Merger Sub votes to adopt this Agreement and thereby approve the Contemplated Transactions.

D. Concurrently with the execution and delivery of this Agreement and as a condition and inducement to Q32’s willingness to enter into this Agreement, the stockholders, officers and directors of Homology set forth on Section A of the Homology Disclosure Schedule (solely in their capacity as stockholders of Homology) are executing support agreements in favor of Q32 in substantially the form attached hereto as Exhibit A (the “Homology Stockholder Support Agreement”), pursuant to which such Persons have, subject to the terms and conditions set forth therein, agreed to vote all of their shares of Homology Common Stock in favor of this Agreement, the Nasdaq Issuance Proposal and the Charter Amendment Proposals.

E. Concurrently with the execution and delivery of this Agreement and as a condition and inducement to Homology’s willingness to enter into this Agreement, the officers, directors and stockholders (together with their Affiliates) of Q32 set forth on Section A of the Q32 Disclosure Schedule (solely in their capacity as stockholders of Q32) are executing support agreements in favor of Homology in substantially the form attached hereto as Exhibit B (the “Q32 Stockholder Support Agreement”), pursuant to which such Persons have, subject to the terms and conditions set forth therein, agreed to vote all of their shares of Q32 Capital Stock in favor of this Agreement.

F. Concurrently with the execution and delivery of this Agreement and as a condition and inducement to Q32’s willingness to enter into this Agreement, the officers and directors of Homology set forth on Section B of

 

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the Homology Disclosure Schedule are executing lock-up agreements in substantially the form attached hereto as Exhibit C (collectively, the “Homology Lock-Up Agreements”).

G. Concurrently with the execution and delivery of this Agreement and as a condition and inducement to Homology’s willingness to enter into this Agreement, the officers, directors and stockholders of Q32 set forth on Section B of the Q32 Disclosure Schedule are executing lock-up agreements in substantially the form attached hereto as Exhibit D (collectively, the “Q32 Lock-Up Agreements”).

H. It is expected that promptly after the Registration Statement is declared effective under the Securities Act, the stockholders of Q32 sufficient to adopt and approve this Agreement and the Merger as required under Delaware Law and Q32’s Organizational Documents will execute and deliver an action by written consent in order to obtain the Required Q32 Stockholder Vote in the form mutually agreed to by Homology and Q32 (each, a “Q32 Stockholder Written Consent” and collectively, the “Q32 Stockholder Written Consents”).

I. Concurrently with the execution and delivery of this Agreement, certain investors have executed a Subscription Agreement by and among Q32 and the Persons named therein (representing an aggregate commitment no less than the Concurrent Investment Amount), pursuant to which such Persons will have agreed to purchase the number of shares of Q32 Capital Stock set forth therein immediately prior to the Effective Time in connection with the Concurrent Financing (the “Subscription Agreement”).

J. Each of the parties hereto intends that, for United States federal income tax purposes, the Merger will qualify as a “reorganization” within the meaning of Section 368(a) of the Internal Revenue Code of 1986, as amended (the “Code”) and the Treasury Regulations, with respect to which each of Homology, Merger Sub, and Q32 are a “party to a reorganization” under Section 368(b) of the Code, and this Agreement is intended to constitute a “plan of reorganization” for purposes of Sections 354, 361 and 368 of the Code and within the meaning of Section 368 of the Code and Treasury Regulations Section 1.368-2(g) (the “Intended Tax Treatment”).

AGREEMENT

The Parties, intending to be legally bound, agree as follows:

ARTICLE I

DEFINITIONS AND INTERPRETATIVE PROVISIONS

1.1 Definitions.

For purposes of this Agreement (including this Section 1.1):

“2024 Equity Incentive Plan” shall mean an equity incentive plan of Homology in form and substance as agreed to by Homology and Q32 (such agreement not to be unreasonably withheld, conditioned or delayed by either Party), reserving for issuance a number of shares of Homology Common Stock to be mutually agreed upon by Homology and Q32 (such agreement not to be unreasonably withheld, conditioned or delayed by either Party).

“2024 ESPP” shall mean an “employee stock purchase plan” of Homology in form and substance as agreed to by Homology and Q32 (such agreement not to be unreasonably withheld, conditioned or delayed by either Party), reserving for issuance a number of shares of Homology Common Stock to be mutually agreed upon to by Homology and Q32 (such agreement not to be unreasonably withheld, conditioned or delayed by either Party).

“2024 Plans” shall mean both the 2024 ESPP and the 2024 Equity Incentive Plan.

 

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“Acceptable Confidentiality Agreement” means a confidentiality agreement containing terms not materially less restrictive in the aggregate to the counterparty thereto than the terms of the Confidentiality Agreement, except such confidentiality agreement need not contain any standstill, non-solicitation or no hire provisions.

“Acquisition Inquiry” means, with respect to a Party, an inquiry, indication of interest or request for information (other than an inquiry, indication of interest or request for information made or submitted by Q32, on the one hand, or Homology, on the other hand, to the other Party) that would reasonably be expected to lead to an Acquisition Proposal, other than, as applicable, with respect to the Legacy Asset Disposition and the Concurrent Financing.

“Acquisition Proposal” means, with respect to a Party, any offer or proposal, whether written or oral (other than an offer or proposal made or submitted by or on behalf of Q32 or any of its Affiliates, on the one hand, or by or on behalf of Homology or any of its Affiliates, on the other hand, to the other Party) contemplating or otherwise relating to any Acquisition Transaction with such Party, other than, as applicable, with respect to the Legacy Asset Disposition and the Concurrent Financing.

“Acquisition Transaction” means any transaction or series of related transactions (other than, as applicable, the Legacy Asset Disposition and the Concurrent Financing) involving:

(i) any merger, consolidation, amalgamation, share exchange, business combination, issuance of securities, acquisition of securities, reorganization, recapitalization, tender offer, exchange offer or other similar transaction: (A) in which a Party is a constituent entity, (B) in which a Person or “group” (as defined in the Exchange Act and the rules promulgated thereunder) of Persons directly or indirectly acquires beneficial or record ownership of securities representing more than 20% of the outstanding securities of any class of voting securities of a Party or any of its Subsidiaries or (C) in which a Party or any of its Subsidiaries issues securities representing more than 20% of the outstanding securities of any class of voting securities of such Party or any of its Subsidiaries; or

(ii) any sale, lease, exchange, transfer, license, acquisition or disposition of any business or businesses or assets that constitute or account for 20% or more of the consolidated book value or the fair market value of the assets of a Party and its Subsidiaries, taken as a whole.

“Affiliate” means, with respect to any Person, any other Person directly or indirectly controlling, controlled by, or under common control with such other Person. For purposes of this definition, “control” when used with respect to any Person means the power to direct the management and policies of such Person, directly or indirectly, whether through the ownership of voting securities or partnership or other ownership interests, by contract or otherwise, and the terms “controlling” and “controlled” have correlative meanings.

“Business Day” means any day other than a day on which banks in the State of New York are authorized or obligated to be closed.

“Cash and Cash Equivalents” means all (i) cash and cash equivalents and (ii) marketable securities, in each case determined in accordance with GAAP.

“COBRA” means the Consolidated Omnibus Budget Reconciliation Act of 1985, as set forth in Section 4980B of the Code and Part 6 of Title I of ERISA.

“Code” means the Internal Revenue Code of 1986, as amended.

“Concurrent Financing” means the issuance and sale of shares of Q32 Capital Stock in a private placement to be consummated immediately prior to the Effective Time pursuant to the Subscription Agreement with aggregate gross cash proceeds of at least the Concurrent Investment Amount.

 

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“Concurrent Financing Allocation Percentage” mean the quotient (rounded to four decimal places) determined by dividing (i) the Concurrent Financing Proceeds by (ii) the Aggregate Valuation.

“Concurrent Financing Merger Shares” means, subject to Section 2.4(g), the product determined by multiplying (i) the Post-Closing Homology Shares by (ii) the Concurrent Financing Allocation Percentage.

“Concurrent Financing Proceeds” means the proceeds resulting from the Concurrent Financing.

“Concurrent Investment Amount” means $42,000,000.

“Confidentiality Agreement” means the Confidentiality Agreement, dated as of July 31, 2023, by and between Q32 and Homology.

“Consent” means any approval, consent, ratification, permission, waiver or authorization (including any Governmental Authorization).

“Contemplated Transactions” means the Merger and the other transactions contemplated by this Agreement, including the CVR Agreement, the Concurrent Financing and the Charter Amendment Proposals.

“Contract” means, with respect to any Person, any written agreement, contract, subcontract, lease (whether for real or personal property), mortgage, license, or other legally binding commitment or undertaking of any nature to which such Person is a party or by which such Person or any of its assets are bound or affected under applicable Law.

“Delaware Law” means the General Corporation Law of the State of Delaware.

“Effect” means any effect, change, event, circumstance, or development.

“Employee Plan” means (i) each “employee benefit plan” within the meaning of Section 3(3) of ERISA whether or not subject to ERISA; (ii) any other plan, program, policy, agreement or arrangement providing for stock options, stock purchases, restricted stock, restricted stock units, phantom equity, other equity or equity-based incentives, employment agreements, bonuses, commissions, severance, retention, deferred compensation, change in control, transaction, supplemental income arrangements, vacation, retirement, pension, profit-sharing, post-retirement health and welfare, fringe, life insurance, perquisites, health, medical, dental, vision, welfare, employee assistance or similar benefits; and (iii) all other plans, programs, policies, agreements or arrangements (whether written or unwritten) providing compensation or benefits to any current or former employee, officer, director, individual independent contractor and other non-employee service provider.

“Encumbrance” means any lien, pledge, hypothecation, charge, mortgage, security interest, lease, license, option, easement, reservation, servitude, adverse title, claim, infringement, interference, option, right of first refusal, preemptive right, community property interest or restriction or encumbrance of any nature (including any restriction on the voting of any security, any restriction on the transfer of any security or other asset, any restriction on the receipt of any income derived from any asset, any restriction on the use of any asset and any restriction on the possession, exercise or transfer of any other attribute of ownership of any asset).

“Enforceability Exceptions” means the (i) Laws of general application relating to bankruptcy, insolvency and the relief of debtors and (ii) rules of law governing specific performance, injunctive relief and other equitable remedies.

“Entity” means any corporation (including any nonprofit corporation), partnership (including any general partnership, limited partnership or limited liability partnership), joint venture, estate, trust, company (including any company limited by shares, limited liability company or joint stock company), firm, society or other enterprise, association, organization or entity, and each of its successors.

 

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“Environmental Law” means any federal, state, local or foreign Law relating to pollution or protection of human health or the environment (including ambient air, surface water, ground water, land surface or subsurface strata), including any law or regulation relating to emissions, discharges, releases or threatened releases of Hazardous Materials, or otherwise relating to the manufacture, processing, distribution, use, treatment, storage, disposal, transport or handling of Hazardous Materials.

“ERISA” means the Employee Retirement Income Security Act of 1974, as amended.

“ERISA Affiliate” means, with respect to any Entity, any other Person that would be treated as a single employer with such Entity, part of the same “controlled group” as such Entity or under common control with such Entity under Sections 414(b), (c), (m) or (o) of the Code, as applicable.

“Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.

“GAAP” means United States generally accepted accounting principles.

“Governmental Authority” means any: (i) nation, state, commonwealth, province, territory, county, municipality, district or other jurisdiction of any nature, (ii) federal, state, local, municipal, foreign, supra-national or other government or institution, (iii) governmental or quasi-governmental authority of any nature (including any governmental division, department, agency, commission, bureau, instrumentality, official, ministry, fund, foundation, center, organization, unit, body or Entity and any court or other tribunal, and for the avoidance of doubt, any taxing authority) or (iv) self-regulatory organization (including Nasdaq).

“Governmental Authorization” means any: (i) permit, license, certificate, franchise, permission, variance, exception, order, approval, clearance, registration, qualification or authorization issued, granted, given or otherwise made available by or under the authority of any Governmental Authority or pursuant to any Law or (ii) right under any Contract with any Governmental Authority.

“Hazardous Materials” means any pollutant, chemical, substance and any toxic, infectious, carcinogenic, reactive, corrosive, ignitable or flammable chemical, or chemical compound, or hazardous substance, material or waste, whether solid, liquid or gas, that is subject to regulation, control or remediation under any Environmental Law, including without limitation, crude oil or any fraction thereof, and petroleum products or by-products.

“Homology Associate” means any current or former employee, officer, director, independent contractor or other non-employee service provider of Homology or any of its Subsidiaries.

“Homology Balance Sheet” means the audited balance sheet of Homology for the years ended December 31, 2021 and December 31, 2022.

“Homology Capitalization Representations” means the representations and warranties of Homology and Merger Sub set forth in Sections 4.6(a) and 4.6(d).

“Homology Contract” means any Contract: (i) to which Homology is a party, (ii) by which Homology or any Homology IP Rights or any other asset of Homology is or may become bound or under which Homology has, or may become subject to, any obligation or (iii) under which Homology has or may acquire any right or interest.

“Homology Covered Person” means, with respect to Homology as an “issuer” for purposes of Rule 506 promulgated under the Securities Act, any Person listed in the first paragraph of Rule 506(d)(1).

“Homology Employee Plan” means any Employee Plan that Homology or any of its Subsidiaries (i) sponsors, maintains, administers, or contributes to, or (ii) provides benefits under or through, or (iii) has any obligation to contribute to or provide benefits under or through, or (iv) may reasonably be expected to have any Liability with respect to, or (v) utilizes to provide benefits to or otherwise cover any Homology Associate.

 

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“Homology Equity Plans” means the Homology 2015 Stock Incentive Plan, as amended from time to time and the Homology 2018 Incentive Award Plan, as amended from time to time.

“Homology ESPP” means the Homology 2018 Employee Stock Purchase Plan, as amended from time to time.

“Homology Fundamental Representations” means the representations and warranties of Homology and Merger Sub set forth in Sections 4.1(a), 4.1(b), 4.2, 4.3, 4.4, and 4.21.

“Homology IP Rights” means all Intellectual Property that is (i) owned by or purported to be owned, whether wholly or jointly with others, by Homology or any of its Subsidiaries (“Homology Owned IP Rights”), or (ii) licensed or sublicensed to Homology or any of its Subsidiaries (“Homology Licensed IP Rights”), in each case (i) and (ii), that is necessary for, or used or held for use in, the operation of the business of Homology as presently conducted.

“Homology IP Rights Agreement” means any Contract governing, related or pertaining to any Homology IP Rights.

“Homology ITM Option” means each Homology Option with an exercise price per share less than the closing trading price of a share of Homology Common Stock on the last full trading day on which the Homology Common Stock is traded prior to the date on which the Effective Time occurs.

“Homology Lease Agreement” means that certain Lease Agreement, dated December 21, 2017, by and between Homology and BCFP One Patriots Park LLC, as may be amended or supplemented from time to time.

“Homology Legacy IP Rights” means all Intellectual Property that is (i) owned by or purported to be owned, whether wholly or jointly with others, by Homology or any of its Subsidiaries, or (ii) licensed or sublicensed to Homology or any of its Subsidiaries, in each case (i) and (ii), that is solely related to the Legacy Assets.

“Homology Material Adverse Effect” means any Effect that, considered together with all other Effects that have occurred prior to the date of determination of the occurrence of a Homology Material Adverse Effect, has had or would reasonably be expected to have a material adverse effect on the business, asset, liabilities, financial condition or results of operations of Homology or its Subsidiaries, taken as a whole; provided, however, that Effects arising or resulting from the following, alone or in combination, shall not be taken into account in determining whether there has been a Homology Material Adverse Effect: (i) the announcement of this Agreement, the pendency or the consummation of the Contemplated Transactions, including any adverse change in customer, supplier, governmental, landlord, employee or similar relationships resulting therefrom or with respect thereto (other than, in the case of this clause (i), for purposes of Section 4.3, Section 4.4, or Section 4.5) (ii) the taking of any action, or the failure to take any action, by Homology that is expressly required under the terms of this Agreement, (iii) any natural disaster or epidemics, pandemics or other force majeure events, or any act or threat of terrorism or war, any armed hostilities or terrorist activities (including any escalation or general worsening of any of the foregoing) anywhere in the world or any governmental or other response or reaction to any of the foregoing, (iv) any change in GAAP or applicable Law or the interpretation thereof, (v) general economic, financial and capital markets, political conditions or conditions, including any instability in the banking sector, including the failure or placement into receivership of any financial institution, in each case generally affecting the industries in which Homology and its Subsidiaries operate, (vi) any change in the cash position of Homology and its Subsidiaries which results from operations in the Ordinary Course of Business, or (vii) any failure of Homology to meet any projections, business plans or forecasts (provided that, this clause (vii) shall not prevent a determination that any change or effect underlying such failure to meet projections, business plans or forecasts has resulted in a Homology Material Adverse Effect (to the extent such change or effect is not otherwise excluded from this definition of Homology Material Adverse Effect)); except in each case with respect to clauses (iii), (iv) and (v), to the extent disproportionately affecting Homology and its Subsidiaries,

 

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taken as a whole, relative to other similarly situated companies in the industries in which Homology and its Subsidiaries operate.

“Homology Net Cash” means without duplication, (i) Homology’s Cash and Cash Equivalents determined, to the extent in accordance with GAAP, in a manner consistent with the manner in which such items were historically determined and in accordance with the financial statements (including any related notes) contained or incorporated by reference in the Homology Balance Sheet, minus (ii) fees and expenses of Homology incurred in connection with the Contemplated Transactions, including for the avoidance of doubt, Transaction Expenses of Homology to the extent unpaid as of the Closing, minus (iii) expenses of Homology incurred in connection with the disposition of Legacy Assets and any contingent obligations or liabilities arising from such dispositions (including the full amount of any indemnity obligations), (iv) minus any and all Liabilities of Homology (A) to any Homology Associate for change in control or transaction bonuses, retention bonuses, severance or similar compensatory payments or benefits that are due and payable as a result of the completion of the Contemplated Transactions, together with any other event (in each case, including the employer portion of any payroll or similar Taxes payable with respect thereto), (B) with respect to the unfunded or underfunded portion of any accrued employer contributions to a defined contribution or any post-retirement health and welfare benefit plan, (C) accrued but unpaid bonuses, severance and vacation or paid time off (including the employer portion of any payroll or similar Taxes payable with respect thereto), (D) with respect to accounts payable, accruals and other current liabilities (which will include the Company’s total deductible under its D&O Insurance less amounts paid prior to Closing (other than in connection with Transaction Litigation) that count toward such deductible), and (E) with respect to contractual commitments for future payments under Homology Real Estate Leases to the extent such commitments are incurred prior to Closing, plus (v) all prepaid expenses set forth on Section 1.1(a)(i) of the Homology Disclosure Schedule, plus (vi) expenses paid, or Liabilities incurred, prior to Closing, that are approved in writing to be covered and reimbursed by Homology’s D&O insurance in excess of the deductible and within overall policy limits; provided that Q32 shall have received true and complete copies of all documentation provided by Homology’s D&O insurance carrier reasonably evidencing that Homology will receive such reimbursements within ninety (90) days of the Anticipated Closing Date, plus (vii) prepaid deposits set forth on Section 1.1(b) of the Homology Disclosure Schedule, and minus (viii) the RSU Withholding Amount and the employer portion of any payroll or similar Taxes payable as a result of the vesting and settlement of each outstanding and unvested Homology Restricted Stock Unit pursuant to Section 5.13. For avoidance of doubt, (1) the Cash and Cash Equivalents received in the Concurrent Financing will be excluded from the calculation of Homology Net Cash and (2) the Cash and Cash Equivalents received from the disposition of Legacy Assets will be included in the calculation of Homology Net Cash.

“Homology Options” means options to purchase shares of Homology Common Stock granted by Homology under the Homology Equity Plans, but, for the avoidance of doubt, excluding the Homology ESPP.

“Homology Registered IP” means all Homology IP Rights that are owned or exclusively licensed by Homology or any of its Subsidiaries that are registered, filed or issued under the authority of, with or by any Governmental Authority, including all Patents, registered copyrights and registered trademarks and all applications for any of the foregoing.

“Homology Restricted Stock Unit Awards” means restricted stock unit awards covering shares of Homology Common Stock granted by Homology under the Homology 2018 Incentive Award Plan, as amended from time to time.

“Homology Triggering Event” shall be deemed to have occurred if: (i) Homology shall have failed to include in the Proxy Statement the Homology Board Recommendation, (ii) the Homology Board or any committee thereof shall have made a Homology Board Adverse Recommendation Change or approved, endorsed or recommended any Acquisition Proposal (other than with Q32), or (iii) Homology shall have entered into any letter of intent or similar document or any Contract relating to any Acquisition Proposal (other than an Acceptable Confidentiality Agreement pursuant to Section 5.4).

 

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“Intellectual Property” means any and all intellectual property and similar proprietary rights throughout the world, including any and all state, United States, international and/or foreign or other territorial or regional rights in, arising out of or associated with any of the following: (i) United States, foreign and international patents, patent applications, including all provisionals, nonprovisionals, substitutions, divisional, continuations, continuations-in-part, reissues, renewals, extensions, supplementary protection certificates, reexaminations, term extensions, confirmations, certificates of invention and the equivalents of any of the foregoing, statutory invention registrations, invention disclosures and inventions (collectively, “Patents”), (ii) trademarks, service marks, trade names, domain names, corporate names, brand names, URLs or other names and locators associated with the internet, trade dress, logos and other source identifiers, including registrations and applications for registration thereof and goodwill associated therewith and symbolized thereby, (iii) works of authorship (whether or not copyrightable) and all copyrights, copyrightable works, derivative works, including registrations and applications for registration thereof, and all renewals, extensions, restorations or reversions of the foregoing, including all rights of authorship, use, publication, publicity, reproduction, distribution, income, performance and transformation, (iv) software, including all source code, object code, firmware, development tools files, records and data, all media on which any of the foregoing is recorded, and all related documentation, (v) all inventions, invention disclosures, improvements, formulae, customer lists, trade secrets, know-how (including recipes, specifications, formulae, manufacturing and other processes, operating procedures, methods, techniques and all research and development information), technology, technical data, databases, data collections, confidential information and other proprietary rights and intellectual property, whether patentable or not, and all documentation relating to any of the foregoing, (vi) all rights to sue or recover and retain damages and costs and attorneys’ fees for the past, present or future infringement, dilution, misappropriation, or other violation of any of the foregoing anywhere in the world.

“IRS” means the United States Internal Revenue Service.

“Key Employee” means, with respect to any Person, (i) an executive officer of such Person; and (ii) any employee of such Person, that reports directly to the chief executive officer of such Person.

“Knowledge” means, with respect to an individual, that such individual is actually aware of the relevant fact or such individual would reasonably be expected to know such fact in the ordinary course of the performance of such individual’s employment responsibilities. Any Person that is an Entity shall have Knowledge if any executive officer or director of such Person as of the date such knowledge is imputed has or should reasonably be expected to have Knowledge of such fact or other matter. With respect to any matters relating to Intellectual Property, such awareness or reasonable expectation to have knowledge does not require any such individual to conduct or have conducted or obtain or have obtained any freedom to operate opinions of counsel or any Intellectual Property rights clearance searches.

“Law” means any federal, state, national, supra-national, foreign, local or municipal or other law. Statute, constitution, principle of common law, resolution, ordinance, code, edict, decree, rule, regulation, ruling or requirement issued, enacted, adopted, promulgated, implemented or otherwise put into effect by or under the authority of any Governmental Authority (including under the authority of Nasdaq or the Financial Industry Regulatory Authority).

“Legacy Asset Proceeds” means the net proceeds, if any, resulting from the Legacy Asset Disposition prior to or concurrently with the Closing.

“Legal Proceeding” means any action, suit, litigation, arbitration, proceeding (including any civil, criminal, administrative, investigative or appellate proceeding), hearing, inquiry, audit, examination or investigation commenced, brought, conducted or heard by or before, or otherwise involving, any court or other Governmental Authority or any arbitrator or arbitration panel.

“Multiemployer Plan” means a “multiemployer plan,” as defined in Section 3(37) or 4001 (a)(3) of ERISA.

 

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“Multiple Employer Plan” means a “multiple employer plan” as described in Section 413(e) of ERISA.

“Multiple Employer Welfare Arrangement” means a “multiple employer welfare arrangement” within the meaning of Section 3(40) of ERISA.

“Nasdaq” means The Nasdaq Stock Market.

“Nasdaq Reverse Split” means a reverse stock split of all outstanding shares of Homology Common Stock at a reverse stock split ratio as mutually agreed to by Homology and Q32 that is effected by Homology prior to the Effective Time.

“Notice Period” means a period of at least three (3) Business Days commencing on the date the Homology Board notifies Q32 in writing of its intent to make a Homology Board Adverse Recommendation Change.

“Order” means any judgment, order, writ, injunction, ruling, decision or decree of (that is binding on a Party), or any plea agreement, corporate integrity agreement, resolution agreement, or deferred prosecution agreement with, or any settlement under the jurisdiction of, any court or Governmental Authority.

“Ordinary Course of Business” means, in the case of each of Q32 and Homology, such actions taken in the ordinary course of its normal operations and consistent with its past practices.

“Organizational Documents” means, with respect to any Person (other than an individual), (i) the certificate or articles of association or incorporation or organization or limited partnership or limited liability company, and any joint venture, limited liability company, operating or partnership agreement and other similar documents adopted or filed in connection with the creation, formation or organization of such Person and (ii) all bylaws, regulations and similar documents or agreements relating to the organization or governance of such Person, in each case, as amended or supplemented.

“Party” or “Parties” means Q32, Homology and Merger Sub.

“Permitted Encumbrance” means (i) any statutory liens for Taxes not yet due and payable or for Taxes that are being contested in good faith and for which adequate reserves have been made on the Q32 Balance Sheet or the Homology Balance Sheet, as applicable, in accordance with GAAP, (ii) liens that have arisen in the Ordinary Course of Business and that do not (in any case or in the aggregate) materially detract from the value of the assets subject thereto or materially impair the operations of Q32 or Homology, as applicable, (iii) statutory liens to secure obligations to landlords, lessors or renters under leases or rental agreements, (iv) deposits or pledges made in connection with, or to secure payment of, workers’ compensation, unemployment insurance or similar programs mandated by Law, (v) statutory liens in favor of carriers, warehousemen, mechanics and materialmen, to secure claims for labor, materials or supplies and (vi) liens arising under applicable securities Law.

“Person” means any individual, Entity or Governmental Authority.

“Personal Information” means (i) data and information concerning an identifiable natural person, or (ii) any information that is regulated or protected by one or more Privacy Laws.

“Privacy Laws” mean Laws relating to privacy, security and/or collection, use or other processing of Personal Information.

“Q32 Associate” means any current or former employee, officer, director, independent contractor or other non-employee service provider of Q32 or any of its Subsidiaries.

“Q32 Balance Sheet” means the audited balance sheet of Q32 for the years ended December 31, 2021 and December 31, 2022.

 

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“Q32 Board” means the board of directors of Q32.

“Q32 Capital Stock” means Q32 Common Stock and Q32 Preferred Stock.

“Q32 Capitalization Representations” means the representations and warranties of Q32 set forth in Sections 3.6(a) and 3.6(d).

“Q32 Common Stock” means the common stock, $0.0001 par value per share, of Q32.

“Q32 Contract” means any Contract: (i) to which Q32 or any of its Subsidiaries is a Party, (ii) by which Q32 or any of its Subsidiaries is or may become bound or under which Q32 or any of its Subsidiaries has, or may become subject to, any obligation or (iii) under which Q32 or any of its Subsidiaries has or may acquire any right or interest.

“Q32 Convertible Notes” means the outstanding unsecured convertible promissory notes, as amended, issued by Q32 pursuant to the Q32 Note Purchase Agreement.

“Q32 Employee Plan” means any Employee Plan that Q32 or any of its Subsidiaries (i) sponsors, maintains, administers, or contributes to, or (ii) provides benefits under or through, or (iii) has any obligation to contribute to or provide benefits under or through, or (iv) may reasonably be expected to have any Liability with respect to, or (v) utilizes to provide benefits to or otherwise cover any Q32 Associate (or their spouses, dependents, or beneficiaries).

“Q32 Equity Plan” means the Q32 2017 Stock Option Plan and Grant Plan, as amended from time to time.

“Q32 Exchange Ratio” means the quotient obtained by dividing (i) the number of Q32 Merger Shares by (ii) the number of Q32 Outstanding Shares.

“Q32 Fundamental Representations” means the representations and warranties of Q32 set forth in Sections 3.1(a), 3.1(b), 3.2, 3.3, 3.4, and 3.20.

“Q32 IP Rights” means all Intellectual Property that is (i) owned by or purported to be owned, whether wholly or jointly with others, by Q32 or any of its Subsidiaries (“Q32 Owned IP Rights”), or (ii) licensed or sublicensed by Q32 or any of its Subsidiaries (“Q32 Licensed IP Rights”), in each case (i) and (ii), that is necessary for, or used or held for use in, the operation of the business of Q32 and its Subsidiaries as presently conducted.

“Q32 IP Rights Agreement” means any Contract governing, related to or pertaining to any Q32 IP Rights other than any confidential information provided under confidentiality agreements.

“Q32 Material Adverse Effect” means any Effect that, considered together with all other Effects that have occurred prior to the date of determination of the occurrence of a Q32 Material Adverse Effect, has had or would reasonably be expected to have a material adverse effect on the business, assets, liabilities, financial condition or results of operations of Q32 or its Subsidiaries, taken as a whole; provided, however, that Effects arising or resulting from the following, alone or in combination, shall not be taken into account in determining whether there has been a Q32 Material Adverse Effect: (i) the announcement of this Agreement, the pendency or the consummation of the Contemplated Transactions, including any adverse change in customer, supplier, governmental, landlord, employee or similar relationships resulting therefrom or with respect thereto (other than, in the case of this clause (i), for purposes of Section 3.3, Section 3.4, or Section 3.5), (ii) the taking of any action, or the failure to take any action, by Q32 that is expressly required under the terms of this Agreement, (iii) any natural disaster or epidemics, pandemics or other force majeure events, or any act or threat of terrorism or war, any armed hostilities or terrorist activities (including any escalation or general worsening of any of the foregoing)

 

10


anywhere in the world or any governmental or other response or reaction to any of the foregoing, (iv) any change in GAAP or applicable Law or the interpretation thereof, (v) general economic, financial and capital markets, political conditions or conditions, including any instability in the banking sector, including the failure or placement into receivership of any financial institution, in each case generally affecting the industries in which Q32 and its Subsidiaries operate, (vi) any change in the cash position of Q32 and its Subsidiaries which results from operations in the Ordinary Course of Business, or (vii) any failure of Q32 to meet any projections, business plans or forecasts (provided that, this clause (vii) shall not prevent a determination that any change or effect underlying such failure to meet projections, business plans or forecasts has resulted in a Q32 Material Adverse Effect (to the extent such change or effect is not otherwise excluded from this definition of Q32 Material Adverse Effect)); except in each case with respect to clauses (iii), (iv) and (v), to the extent disproportionately affecting Q32 and its Subsidiaries, taken as a whole, relative to other similarly situated companies in the industries in which Q32 and its Subsidiaries operate.

“Q32 Merger Shares” means, subject to Section 2.4(f), the product determined by multiplying (i) the Post-Closing Homology Shares by (ii) the Q32 Allocation Percentage, in which:

 

  (i)

“Aggregate Valuation” means the sum of (A) the Q32 Equity Value, plus (B) the Homology Valuation, plus (C) the Concurrent Financing Proceeds.

 

  (ii)

“Homology Allocation Percentage” means the quotient (rounded to four decimal places) determined by dividing (A) the Homology Valuation by (B) the Aggregate Valuation.

 

  (iii)

“Homology Equity Value” means $80,000,000.

 

  (iv)

“Homology Outstanding Shares” means, subject to Section 2.4(f) (including, without limitation, the effects of the Nasdaq Reverse Split), the total number of shares of Homology Common Stock outstanding immediately prior to the Effective Time expressed on a fully-diluted basis, and assuming, without limitation or duplication, (A) the issuance of shares of Homology Common Stock in respect of all Homology ITM Options that will be outstanding as of immediately prior to the Effective Time calculated on a “treasury method” basis, (B) the settlement in shares of Homology Common Stock of Homology Restricted Stock Units outstanding as of immediately prior to the Effective Time on a net settlement basis as provided in Section 5.13 and (C) the exclusion of shares of Homology Common Stock held by Homology as treasury stock or owned by Q32 or any of its Subsidiaries or any Subsidiary of Homology immediately prior to the Effective Time.

 

  (v)

“Homology Valuation” means (A) the Homology Equity Value minus (B) the Homology Net Cash Deficiency (if any) plus (C) the Homology Net Cash Surplus (if any).

 

  (vi)

“Q32 Allocation Percentage” means the quotient (rounded to four decimal places) determined by dividing (A) the Q32 Equity Value by (B) the Aggregate Valuation.

 

  (vii)

“Q32 Equity Value” means $195,000,000.

 

  (viii)

“Homology Net Cash Deficiency” means, if Homology Net Cash is less than $59,500,000, then the amount, if any, that $60,000,000 exceeds the Homology Net Cash, calculated as of 12:01 am Eastern time on the Closing Date; provided, however, any such calculation with respect to Taxes shall be calculated as of the end of the Closing Date.

 

  (ix)

“Post-Closing Homology Shares” mean the quotient determined by dividing (A) the Homology Outstanding Shares by (B) the Homology Allocation Percentage.

 

  (x)

“Homology Net Cash Surplus” means, if Homology Net Cash is greater than $60,500,000, then the amount, if any, that the Homology Net Cash exceeds $60,000,000, calculated as of 12:01 am Eastern time on the Closing Date; provided, however, any such calculation with respect to Taxes shall be calculated as of the end of the Closing Date.

For the avoidance of doubt, the Concurrent Financing Proceeds shall not be included in the calculation or determination of the Homology Valuation or any component thereof. Set forth on Section 1.1(a)(ii) on the

 

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Homology Disclosure Schedule is an illustrative example of the calculation of the Q32 Merger Shares calculation.

“Q32 Note Purchase Agreement” means the Note Purchase Agreement, by and among Q32 and the other parties thereto, dated as of May 20, 2022, as may be amended or supplemented from time to time.

“Q32 Outstanding Shares” means, the total number of shares of Q32 Common Stock outstanding immediately prior to the Effective Time (after giving effect to the Q32 Preferred Stock Conversion and the conversion of the Q32 Convertible Notes) expressed on a fully-diluted and as-converted to Q32 Common Stock on a “treasury method” basis and assuming, without limitation or duplication, the issuance of all shares of Q32 Common Stock that would be issued assuming the acceleration and exercise and conversion of all Q32 Options and Q32 Warrants outstanding as of immediately prior to the Effective Time.

“Q32 Options” means options to purchase shares of Q32 Common Stock granted by Q32 under the Q32 Equity Plan.

“Q32 Preferred Stock” means, collectively, the Series A Preferred Stock, Series A1 Preferred Stock and Series B Preferred Stock,

“Q32 Registered IP” means all Q32 IP Rights that are owned or exclusively licensed by Q32 or any of its Subsidiaries that are registered, filed, issued or otherwise granted under the authority of, with or by any Governmental Authority, including all patents, registered copyrights and registered trademarks and all applications and registrations for any of the foregoing.

“Q32 Series A1 Preferred Stock” means the preferred stock, $0.0001 par value per share, of Q32, designated as Series A1 Preferred Stock.

“Q32 Series A Preferred Stock” means the preferred stock, $0.0001 par value per share, of Q32, designated as Series A Preferred Stock.

“Q32 Series B Preferred Stock” means the preferred stock, $0.0001 par value per share, of Q32, designated as Series B Preferred Stock.

“Q32 Triggering Event” shall be deemed to have occurred if: (i) Q32 Board or any committee thereof shall have approved, endorsed or recommended any Acquisition Proposal or (ii) Q32 shall have entered into any letter of intent or similar document or any Contract relating to any Acquisition Proposal (other than an Acceptable Confidentiality Agreement as pursuant to Section 5.4).

“Q32 Warrants” means options to purchase shares of Q32 Common Stock issued under the Warrant Agreements.

“Representatives” means, with respect to any Person, such Person’s directors, officers, employees, agents, attorneys, accountants, investment bankers, advisors and representatives.

“Sarbanes-Oxley Act” means the Sarbanes-Oxley Act of 2002.

“SEC” means the United States Securities and Exchange Commission.

“Securities Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.

 

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“Subsequent Transaction” means any Acquisition Transaction (with all references to 20% in the definition of Acquisition Transaction being treated as references to 50% for these purposes).

“Subsidiary” means, with respect to a Person, an Entity of which more than 50% of the voting power of the equity securities or equity interests is owned, directly or indirectly, by such Person.

“Superior Offer” means an unsolicited bona fide written Acquisition Proposal (with all references to 20% in the definition of Acquisition Transaction being treated as references to 50% for these purposes) that: (i) was not obtained or made as a direct or indirect result of a breach of (or in violation of) this Agreement and (ii) is on terms and conditions that the Q32 Board or the Homology Board, as applicable, determines in good faith, based on such matters that it deems relevant (including the likelihood of consummation thereof and the financing terms and any termination or break-up fees and conditions to consummation thereof), as well as any written offer by the other Party to this Agreement to amend the terms of this Agreement, and following consultation with its outside legal counsel and financial advisors, if any, are more favorable, from a financial point of view, to Q32’s stockholders or Homology’s stockholders, as applicable, than the terms of the Contemplated Transactions and is not subject to any financing conditions (and if financing is required, such financing is then fully committed to the third party).

“Tax” means (i) any U.S. federal, state or local or non-U.S. tax, including any income tax, franchise tax, capital gains tax, gross receipts tax, value-added tax, surtax, estimated tax, unemployment tax, excise tax, ad valorem tax, transfer tax, stamp tax, sales tax, use tax, property tax, business tax, withholding tax, imputed underpayment amount, payroll tax, customs duty, escheat, unclaimed property, alternative or add-on minimum or other tax or similar charge (whether imposed directly or through withholding and whether or not disputed), and including any fine, penalty, addition to tax, interest or additional amount imposed by a Governmental Authority with respect thereto (or attributable to the nonpayment thereof) and (ii) any liability for payment of amounts described in clause (i) whether as a result of transferee or successor liability, of being a member of an affiliated, consolidated, combined or unitary group for any period, pursuant to a Contract, through operation of Law or otherwise.

“Tax Return” means any return (including any information return), report, statement, declaration, claim or refund, estimate, schedule, notice, notification, form, election, certificate or other document or information, and any amendment or supplement to any of the foregoing, filed or required to be filed with any Governmental Authority (or provided to a payee) in connection with the determination, assessment, collection or payment of any Tax or in connection with the administration, implementation or enforcement of or compliance with any Law relating to any Tax.

“Transaction Expenses” means, with respect to a Party, the aggregate amount (without duplication) of all costs, fees, and expenses incurred by such Party or any of its Subsidiaries (including Merger Sub), or for which such Party or any of its Subsidiaries are or may become liable in connection with the Contemplated Transactions and the negotiation, preparation and execution of this Agreement or any other agreement, document, instrument, filing, certificate, schedule, exhibit, letter or other document prepared or executed in connection with the Contemplated Transactions, including (i) any fees and expenses of legal counsel and accountants, the maximum amount of fees and expenses payable to financial advisors, investment bankers, brokers, consultants, tax advisors, transfer agents, proxy solicitor and other advisors of such Party; (ii) the premiums, commissions and other fees paid or payable in connection with obtaining Homology’s D&O tail policy as set forth in Section 5.15(d); (iii) the premiums, commissions and other fees paid or payable in connection with obtaining Homology’s Clinical Trial Insurance tail policy; and (iv) the CVR Fees.

“Treasury Regulations” means the United States Treasury regulations promulgated under the Code.

“WARN Act” means the Worker Adjustment and Retraining Notification Act of 1988, as amended, and any similar or related law.

 

13


“Warrant Agreements” means that certain (i) Warrant to Purchase Common Stock, by and between Q32 Bio Inc. and Silicon Valley Bank, issued on December 11, 2020 for 166,371 shares of Q32 Common Stock at an exercise price of $0.33 per share (subject to adjustments) and (ii) Warrant to Purchase Common Stock, by and between Q32 Bio Inc. and Silicon Valley Bank, issued on July 12, 2023 for 211,528 shares of Q32 Common Stock at an exercise price of $0.36 per share (subject to adjustments).

(ii) Each of the following terms is defined in the Section set forth opposite such term:

 

Term

  

Section

Abandoned Homology Legacy IP Rights

   5.2

Accounting Firm

   2.8(e)

Agreement

   Preamble

Allocation Certificate

   5.22

Anticipated Closing Date

   2.8(a)

Assumed Option

   2.4(g)

Assumed Option

   2.4(i)

Authorized Share Increase Proposal

   Recitals

Cash Determination Time

   2.8(a)

Capitalization Date

   4.6(a)

Certificate of Merger

   2.1

Charter Amendment Proposals

   Recitals

Closing

   2.2

Closing Date

   2.2

Code

   Recitals

Costs

   5.15(a)

Current Offering Period

   5.15(a)

CVR

   2.5(a)

CVR Agreement

   2.5(a)

CVR Fees

   2.5(b)

D&O Indemnified Parties

   5.15(a)

D&O tail policy

   5.15(d)

Delivery Date

   2.8(a)

Dispute Notice

   2.8(b)

Disqualifying Event

   4.22

Drug Regulatory Agency

   3.14(c)

Effective Time

   2.1

Exchange Agent

   2.7(a)

FDA

   3.14(c)

FDCA

   3.14(c)

Final Homology Net Cash

   2.8(c)

Form S-4

   5.7(a)

Homology

   Preamble

Homology Board

   Recitals

Homology Board Adverse Recommendation Change

   5.9(b)

Homology Board Recommendation

   5.9(b)

Homology Certifications

   4.7(a)

Homology Closing Certificate

   6.2(d)

Homology Common Stock

   4.6(a)

Homology Designee

   5.19(a)(i)

Homology Disclosure Schedule

   Article IV

Homology IT Systems

   4.23(b)

Homology Lease Agreement

   5.5(b)

 

14


Term

  

Section

Homology Lock-Up Agreements

   Recitals

Homology Material Contract

   4.13(a)

Homology Net Cash Calculation

   2.8(a)

Homology Net Cash Schedule

   2.8(a)

Homology Permits

   4.14(b)

Homology Preferred Stock

   4.6(a)

Homology Product Candidates

   4.14(d)

Homology Regulatory Permits

   4.14(d)

Homology Real Estate Leases

   4.11

Homology Stockholder Matters

   5.9(a)

Homology Stockholder Meeting

   5.9(a)

Homology Stockholder Support Agreement

   Recitals

Information Statement

   5.8(a)

Intended Tax Treatment

   Recitals

Legacy Assets

   0

Legacy Asset Disposition

   0

Liability

   3.9

Merger

   Recitals

Merger Sub

   Preamble

Merger Sub Board

   Recitals

Nasdaq Issuance Proposal

   Recitals

Ordinary Course Agreement

   3.16(f)

Outside Date

   8.1(b)

PHSA

   3.14(c)

Pre-Closing Distribution

   2.5(a)

Pre-Closing Period

   5.1

Privacy Policies

   3.22(a)

Proxy Statement

   5.7(a)

Q32

   Preamble

Q32 Board Recommendation

   5.8(c)

Q32 Certification

   3.7(a)

Q32 Closing Certificate

   6.3(d)

Q32 Designee

   5.19(a)(i)

Q32 Disclosure Schedule

   Article III

Q32 Financial Statements

   3.7(a)

Q32 IT Systems

   3.22(b)

Q32 Lock-Up Agreements

   Recitals

Q32 Material Contract

   3.13(a)

Q32 Permits

   3.14(b)

Q32 Preferred Stock Conversion

   2.4(h)

Q32 Product Candidates

   3.14(d)

Q32 Real Estate Leases

   3.11

Q32 Regulatory Permits

   3.14(d)

Q32 Stockholder Support Agreement

   Recitals

Q32 Stockholder Written Consents

   Recitals

Registration Statement

   5.7(a)

Required Homology Stockholder Vote

   4.4

Required Q32 Stockholder Vote

   3.4

Response Date

   2.8(b)

Reverse Stock Split Proposal

   Recitals
RSU Withholding Amount    5.13

 

15


Term

  

Section

Subscription Agreement    Recitals
Surviving Corporation    2.1
Transfer Tax    5.16(a)

1.2 Other Definitional and Interpretative Provisions. The words “hereof,” “herein” and “hereunder” and words of like import used in this Agreement shall refer to this Agreement as a whole and not to any particular provision of this Agreement. The captions herein are included for convenience of reference only and shall be ignored in the construction or interpretation hereof. References to Sections, Exhibits and Schedules are to Sections, Exhibits and Schedules of this Agreement unless otherwise specified. Any capitalized terms used in any Exhibit or Schedule but not otherwise defined therein shall have the meaning as defined in this Agreement. Any singular term in this Agreement shall be deemed to include the plural, and any plural term the singular, the masculine gender shall include the feminine and neuter genders; the feminine gender shall include the masculine and neuter genders; and the neuter gender shall include masculine and feminine gender. Whenever the words “include,” “includes” or “including” are used in this Agreement, they shall be deemed to be followed by the words “without limitation,” whether or not they are in fact followed by those words or words of like import. The word “or” is not exclusive. “Writing,” “written” and comparable terms refer to printing, typing and other means of reproducing words (including electronic media) in a visible form. References to any agreement or Contract are to that agreement or Contract as amended, modified or supplemented from time to time in accordance with the terms hereof and thereof. References to any Person include the successors and permitted assigns of that Person. References to any statute are to that statute and to the rules and regulations promulgated thereunder, in each case as amended, modified, re-enacted thereof, substituted, from time to time. References to “$” and “dollars” are to the currency of the United States. All accounting terms used herein will be interpreted, and all accounting determinations hereunder will be made, in accordance with GAAP unless otherwise expressly specified. References from or through any date shall mean, unless otherwise specified, from and including or through and including, respectively. All references to “days” shall be to calendar days unless otherwise indicated as a “Business Day.” Except as otherwise specifically indicated, for purposes of measuring the beginning and ending of time periods in this Agreement (including for purposes of “Business Day” and for hours in a day or Business Day), the time at which a thing, occurrence or event shall begin or end shall be deemed to occur in the Eastern time zone of the United States. The Parties agree that any rule of construction to the effect that ambiguities are to be resolved against the drafting Party shall not be applied in the construction or interpretation of this Agreement. The Parties agree that the Q32 Disclosure Schedule or the Homology Disclosure Schedule shall be arranged in sections and subsections corresponding to the numbered and lettered sections and subsections contained in Article III or Article IV respectively. The disclosures in any section or subsection of the Q32 Disclosure Schedule or the Homology Disclosure Schedule shall qualify other sections and subsections in Article III or Article IV respectively, to the extent it is readily apparent from a reading of the disclosure that such disclosure is applicable to such other sections and subsections. The words “delivered” or “made available” mean, with respect to any documentation, (a) that prior to 5:00 p.m. (New York City time) on the date that is the day prior to the date of this Agreement, a copy of such material has been posted to and made available by a Party to the other Party and its Representatives in the electronic data room maintained by such disclosing Party for the purposes of the Contemplated Transactions or (b) delivered by or on behalf of a Party or its Representatives to the other Party or its Representatives via electronic mail prior to the execution of this Agreement. The inclusion of any information in the Q32 Disclosure Schedule or Homology Disclosure Schedule (or any update thereto) shall not be deemed to be an admission or acknowledgement, in and of itself, that such information is required by the terms hereof to be disclosed, is material, has resulted in or would result in a Q32 Material Adverse Effect or Homology Material Adverse Effect, as the case may be, or is outside the Ordinary Course of Business.

 

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ARTICLE II

THE MERGER

2.1 The Merger. Upon the terms and subject to the conditions set forth in this Agreement and subject to the applicable provisions of Delaware Law, at the Closing, Homology and Q32 shall cause Merger Sub to be merged with and into Q32, whereupon the separate existence of Merger Sub shall cease and Q32 shall continue as the Surviving Corporation of the Merger and as a wholly owned subsidiary of Homology (the “Surviving Corporation”). At the Closing, Homology and Q32 shall cause the Merger to be consummated and effective under Delaware Law by executing and filing with the Secretary of State of the State of Delaware a certificate of merger, satisfying the applicable requirements of Delaware Law in a form to be mutually agreed by the Parties prior to the Closing (the “Certificate of Merger”). The Merger shall become effective at the time of the filing of such Certificate of Merger and the acceptance by the Secretary of State of the State of Delaware, or at such later time as may be specified in such Certificate of Merger with the consent of Homology and Q32 (the time as of which the Merger becomes effective being referred to as the “Effective Time”).

2.2 Closing. Subject to the satisfaction or waiver of the conditions set forth in this Agreement, the consummation of the Merger (the “Closing”) shall take place remotely, (a) no later than the second (2nd) Business Day after all the conditions precedent set forth in Article VI shall have been satisfied or waived (other than those conditions that, by their nature, are to be satisfied at the Closing (provided such conditions would be so satisfied)) or (b) at such other time, date and place as the Parties may mutually agree in writing. The date on which the Closing actually takes place is referred to as the “Closing Date”.

2.3 Organizational Documents; Directors and Officers.

(a) Certificate of Incorporation. The certificate of incorporation of the Surviving Corporation shall be amended and restated at or prior to the Effective Time as set forth in an exhibit to the Certificate of Merger, and as so amended and restated shall be the certificate of incorporation of the Surviving Corporation until thereafter amended as provided by Delaware Law. Homology shall further take all actions necessary so that the certificate of incorporation of Homology shall remain in effect following the Effective Time, until thereafter amended as provided by Delaware Law, provided, however, that at or prior to the Effective Time, Homology shall file one or more amendments to its certificate of incorporation to (i) change the name of Homology to Q32 Bio Inc., (ii) effect the Nasdaq Reverse Split and the Authorized Share Increase Proposal and (iii) make such other changes as are mutually agreeable to Homology and Q32.

(b) Bylaws. The bylaws of the Surviving Corporation shall be amended and restated as of the Effective Time to be the same as the bylaws of Merger Sub as in effect immediately prior to the Effective Time (with the name of Q32 as the Surviving Corporation’s name) until thereafter amended in accordance with Delaware Law and as provided in the Surviving Corporation’s Organizational Documents.

(c) Directors and Officers. The directors and officers, each to hold office in accordance with the provisions of Delaware Law and the Surviving Corporation’s Organizational Documents immediately after the Effective Time, shall be as set forth in Section 5.19.

2.4 Conversion of Shares.

(a) At the Effective Time (after giving effect to Q32 Preferred Stock Conversion), by virtue of the Merger and without any further action on the part of Homology, Merger Sub, Q32 or any stockholder of Q32, subject to Section 2.4(d), the Q32 Common Stock outstanding immediately prior to the Effective Time (excluding Q32 Common Stock issued in the Concurrent Financing) shall be converted solely into the right to receive a number of shares of Homology Common Stock equal to the amount of Q32 Merger Shares multiplied by the applicable stockholder’s percentage interest in Q32 as set forth on the Allocation Certificate.

 

17


(b) At the Effective Time, by virtue of the Merger and without further action on the part of Homology, Merger Sub, Q32 or any stockholder of Q32, subject to Section 2.4(d), the Q32 Common Stock issued in the Concurrent Financing shall be converted solely into the right to receive a number of shares of Homology Common Stock equal to the amount of Concurrent Financing Merger Shares multiplied by the percentage of the Concurrent Financing Proceeds represented by the applicable stockholder’s investment in the Concurrent Financing, as set forth on the Allocation Certificate.

(c) If any Q32 Common Stock outstanding immediately prior to the Effective Time is unvested or is subject to a repurchase option or a risk of forfeiture under any applicable restricted stock, restricted stock unit award agreement or other similar agreement with Q32, then the shares of Homology Common Stock issued in exchange for such Q32 Common Stock will to the same extent be unvested and subject to the same repurchase option or risk of forfeiture, and such shares of Homology Common Stock shall accordingly be marked with appropriate legends. Q32 shall take all actions that may be necessary to ensure that, from and after the Effective Time, Homology is entitled to exercise any such repurchase option or other right set forth in any such restricted stock unit award agreement or other agreement.

(d) No fractional shares of Homology Common Stock shall be issued in connection with the Merger, and no certificates or scrip for any such fractional shares shall be issued, with no cash being paid for any fractional share eliminated by such rounding. Any fractional shares of Homology Common Stock a holder of Q32 Common Stock would otherwise be entitled to receive shall be aggregated together first prior to eliminating any remaining fractional share.

(e) At the Effective Time, by virtue of the Merger and without any further action on the part of Homology, Merger Sub, Q32 or any stockholder of Q32, each share of common stock, $0.01 par value per share, of Merger Sub issued and outstanding immediately prior to the Effective Time shall be converted into and exchanged for one validly issued, fully paid and nonassessable share of common stock, $0.0001 par value per share, of the Surviving Corporation. If applicable, each stock certificate of Merger Sub evidencing ownership of any such shares shall, as of the Effective Time, evidence ownership of such shares of common stock of the Surviving Corporation until presented for transfer or exchange.

(f) If, between the date of this Agreement and the Effective Time, the outstanding Q32 Common Stock or Homology Common Stock shall have been changed into, or exchanged for, a different number of shares or a different class, by reason of any stock dividend, subdivision, reclassification, recapitalization, split (including the Nasdaq Reverse Split to the extent such split has not previously been taken into account in calculating Q32 Merger Shares), combination or exchange of shares or other like change, Q32 Merger Shares shall, to the extent necessary, be equitably adjusted to reflect such change to the extent necessary to provide the holders of Q32 Common Stock and Homology Common Stock with the same economic effect as contemplated by this Agreement prior to such stock dividend, subdivision, reclassification, recapitalization, split, combination or exchange of shares or other like change; provided, however, that nothing herein will be construed to permit Q32 or Homology to take any action with respect to Q32 Common Stock or Homology Common Stock, respectively, that is prohibited or not expressly permitted by the terms of this Agreement.

(g) Each Q32 Option outstanding immediately prior to the Effective Time shall automatically without any further action on the part of Homology, Merger Sub, Q32 or any holder of a Q32 Option, be converted, at the Effective Time, into an option (an “Assumed Option”) to acquire, on the same terms and conditions (including the same vesting and exercisability terms and conditions) as were applicable under the Q32 Equity Plan and option agreement applicable to such Q32 Option immediately prior to the Effective Time, the number of shares of Homology Common Stock determined by multiplying the number of shares of Q32 Common Stock subject to such Q32 Option immediately prior to the Effective Time by the Q32 Exchange Ratio, rounding down to the nearest whole number of shares, at a per share exercise price determined by dividing the per share exercise price of such Q32 Option immediately prior to the Effective Time by the Q32 Exchange Ratio, rounding up to the nearest whole cent; provided, that the conversion of the Q32 Options will be made in a manner consistent with

 

18


Treasury Regulations Section 1.424-1, such that the conversion will not constitute a “modification” of such Q32 Options for purposes of Section 409A or Section 424 of the Code. As of the Effective Time, Homology will assume the Q32 Equity Plan.

(h) All Q32 Preferred Stock shall be converted into Q32 Common Stock as of immediately prior to the Effective Time in accordance with, and pursuant to the terms and conditions of, the Organizational Documents of Q32 (the “Q32 Preferred Stock Conversion”).

(i) At the Effective Time, each Q32 Warrant, to the extent outstanding and unexercised, shall automatically, without any action on the part of the holder thereof, be converted into a warrant to acquire a number of shares of Homology Common Stock(each such resulting warrant, an “Assumed Warrant”). Each Assumed Warrant shall be subject to the same terms and conditions as were applicable to such corresponding Q32 Warrant immediately prior to the Effective Time (including applicable vesting conditions), except (i) each Assumed Warrant will be exercisable (or will become exercisable in accordance with its terms) for that number of whole shares of Homology Common Stock equal to the product of the number of Q32 Merger Shares that were issuable upon exercise of such Q32 Warrant immediately prior to the Effective Time multiplied by the Q32 Exchange Ratio, rounded down to the nearest whole number of shares of Homology Common Stock, (ii) the per share exercise price for the shares of Homology Common Stock issuable upon exercise of such Assumed Warrant will be equal to the quotient determined by dividing the exercise price per share of Q32 Common Stock at which such Q32 Warrant was exercisable immediately prior to the Effective Time by the Q32 Exchange Ratio, rounded up to the nearest whole cent, and (iii) for terms rendered inoperative by reason of the transactions contemplated by this Agreement (including any anti-dilution or other similar provisions that adjust the number of underlying shares that could become exercisable subject to such Q32 Warrant).

(j) Immediately prior to the Effective Time, the Company shall cause the outstanding principal and accrued but unpaid interest on Q32 Convertible Notes to be converted into the applicable number of shares of Q32 Common Stock provided for under the terms of such Q32 Convertible Note (the “Convertible Notes Conversion”). All of Q32 Convertible Notes converted into shares of Q32 Common Stock shall no longer be outstanding and shall cease to exist, and each holder of Q32 Convertible Notes shall thereafter cease to have any rights with respect to Q32 Convertible Notes. Immediately following the Convertible Notes Conversion, at the Effective Time and by virtue of the Merger, all shares of Q32 Common Stock issued in the Convertible Notes Conversion shall be canceled and converted into the right to receive Homology Common Stock pursuant to this Section 2.4.

2.5 Contingent Value Right.

(a) Prior to the Effective Time, Homology shall declare a distribution (the “Pre-Closing Distribution”) to holders of Homology Common Stock of record the right to receive one contingent value right (each, a “CVR”) for each outstanding share of Homology Common Stock held by such stockholder as of such date, each representing the right to receive contingent payments upon the occurrence of certain events set forth in, and subject to and in accordance with the terms and conditions of, the Contingent Value Rights Agreement in the form attached hereto as Exhibit E, to be entered into between Homology and Equiniti Trust Company, LLC (or such other nationally recognized rights agent agreed to between Homology and Q32) (the “Rights Agent”), with such revisions thereto requested by the Rights Agent that are not, individually or in the aggregate, materially detrimental to the holders of CVRs and reasonably acceptable to Homology and Q32 (the “CVR Agreement”). The record date for the Pre-Closing Distribution shall be the close of business on the last Business Day prior to the day on which the Effective Time occurs and the payment date for the Pre-Closing Distribution shall be three (3) Business Days after the Effective Time; provided that the payment of such distribution may be conditioned upon the occurrence of the Effective Time. In connection with the Pre-Closing Distribution, Homology shall cause the CVR Agreement to be duly authorized, executed and delivered by Homology and the Exchange Agent.

(b) Homology agrees to pay all reasonable costs and fees associated with any action contemplated by this Section 2.5 (the “CVR Fees”).

 

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2.6 Closing of Q32’s Transfer Books. At the Effective Time: (a) all Q32 Common Stock outstanding immediately prior to the Effective Time shall be treated in accordance with Section 2.4(a) and Section 2.4(b), as applicable, and all holders of certificates representing Q32 Common Stock that were outstanding immediately prior to the Effective Time shall cease to have any rights as stockholders of Q32 (other than the right to receive Q32 Merger Shares) and (b) the stock transfer books of Q32 shall be closed with respect to all Q32 Common Stock outstanding immediately prior to the Effective Time. No further transfer of any such Q32 Common Stock shall be made on such stock transfer books after the Effective Time.

2.7 Surrender of Q32 Common Stock.

(a) On or prior to the Closing Date, Homology and Q32 shall jointly select a reputable bank, transfer agent or trust company to act as exchange agent in the Merger (the “Exchange Agent”). At the Effective Time, Homology shall deposit with the Exchange Agent evidence of book-entry shares representing the shares of Homology Common Stock issuable pursuant to Section 2.4(a) in exchange for Q32 Common Stock.

(b) Promptly after the Effective Time, the Parties shall cause the Exchange Agent to mail to the Persons who were record holders of Q32 Common Stock that were converted into the right to receive Q32 Merger Shares: (i) a letter of transmittal in customary form and containing such provisions as Homology may reasonably specify and (ii) instructions for effecting the surrender of Q32 Common Stock in exchange for book-entry shares of Homology Common Stock. Upon surrender of a duly executed letter of transmittal and such other documents as may be reasonably required by the Exchange Agent or Homology, the holder of such Q32 Common Stock shall be entitled to receive in exchange therefor book-entry shares representing Q32 Merger Shares (in a number of whole shares of Homology Common Stock) that such holder has the right to receive pursuant to the provisions of Section 2.4(a).

(c) No dividends or other distributions declared or made with respect to Homology Common Stock with a record date after the Effective Time shall be paid to the holder of any Q32 Common Stock with respect to the shares of Homology Common Stock that such holder has the right to receive in the Merger until such holder delivers a duly executed letter of transmittal (at which time (or, if later, on the applicable payment date) such holder shall be entitled, subject to the effect of applicable abandoned property, escheat or similar Laws, to receive all such dividends and distributions, without interest).

(d) Any shares of Homology Common Stock deposited with the Exchange Agent that remain undistributed to holders of Q32 Common Stock as of the date that is 180 days after the Closing Date shall be delivered to Homology upon demand, and any holders of Q32 Common Stock who have not theretofore delivered a duly executed letter of transmittal in accordance with this Section 2.7 shall thereafter look only to Homology for satisfaction of their claims for Homology Common Stock and any dividends or distributions with respect to shares of Homology Common Stock.

(e) No Party shall be liable to any holder of any Q32 Common Stock or to any other Person with respect to any shares of Homology Common Stock (or dividends or distributions with respect thereto) or for any cash amounts delivered to any public official pursuant to any applicable abandoned property Law, escheat Law or similar Law.

2.8 Calculation of Net Cash.

(a) Not less than ten (10) Business Days prior to the anticipated date for Closing as mutually agreed in good faith by Homology and Q32 (the “Anticipated Closing Date”), Homology will deliver to Q32 a schedule (the “Homology Net Cash Schedule”, and the date of delivery of the Homology Net Cash Schedule, the “Delivery Date”) setting forth, in reasonable detail, Homology’s good faith, estimated calculation of Homology Net Cash (the “Homology Net Cash Calculation”) as of the close of business on the Closing Date (the “Cash Determination Time”) prepared and certified by Homology’s chief financial officer (or if there is no chief

 

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financial officer at such time, the principal financial and accounting officer for Homology). Homology shall make available to Q32 (electronically to the greatest extent possible), as reasonably requested by Q32, the work papers and back-up materials used or useful in preparing the Homology Net Cash Schedule and, if reasonably requested by Q32, Homology’s accountants and counsel at reasonable times and upon reasonable notice. The Homology Net Cash Calculation shall include Homology’s determination, as of the Cash Determination Time, of the defined terms in Section 1.1 necessary to calculate Q32 Merger Shares. Set forth on Section 2.8(a) of the Homology Disclosure Schedule is an illustrative example of Homology Net Cash calculation calculated on a hypothetical basis as of the date described therein.

(b) Within five (5) Business Days after the Delivery Date (the last day of such period, the “Response Date”), Q32 shall have the right to dispute any part of the Homology Net Cash Calculation by delivering a written notice to that effect to Homology (a “Dispute Notice”). Any Dispute Notice shall identify in reasonable detail and to the extent known the nature and amounts of any proposed revisions to the Homology Net Cash Calculation.

(c) If, on or prior to the Response Date, Q32 notifies Homology in writing that it has no objections to the Homology Net Cash Calculation or, if prior to 5:00 p.m. (New York City time) on the Response Date, Q32 has failed to deliver a Dispute Notice as provided in Section 2.8(b), then the Homology Net Cash Calculation as set forth in the Homology Net Cash Schedule shall be deemed to have been finally determined for purposes of this Agreement and to represent the Homology Net Cash at the Cash Determination Time (the “Final Homology Net Cash”) for purposes of this Agreement.

(d) If Q32 delivers a Dispute Notice on or prior to 5:00 p.m. (New York City time) on the Response Date, then Representatives of Homology and Q32 shall promptly, and in no event later than one calendar day after the Response Date, meet and attempt in good faith to resolve the disputed item(s) and negotiate an agreed-upon determination of Homology Net Cash, which agreed upon Homology Net Cash amount shall be deemed to have been finally determined for purposes of this Agreement and to represent the Final Homology Net Cash for purposes of this Agreement.

(e) If Representatives of Homology and Q32 are unable to negotiate an agreed-upon determination of Final Net Cash pursuant to Section 2.8(d) within two (2) calendar days after delivery of the Dispute Notice (or such other period as Homology and Q32 may mutually agree upon), then any remaining disagreements as to the calculation of Homology Net Cash shall be referred to an independent auditor of recognized national standing jointly selected by Homology and Q32 or another independent auditor of recognized national standing mutually agreed upon by Homology and Q32 (the “Accounting Firm”). Homology shall promptly deliver to the Accounting Firm all work papers and back-up materials used in preparing the Homology Net Cash Schedule, and Homology and Q32 shall use commercially reasonable efforts to cause the Accounting Firm to make its determination within five (5) calendar days of accepting its selection. Homology and Q32 shall be afforded the opportunity to present to the Accounting Firm any material related to the unresolved disputes and to discuss the issues with the Accounting Firm; provided, however, that no such presentation or discussion shall occur without the presence of a Representative of each of Homology and Q32. The determination of the Accounting Firm shall be limited to the disagreements submitted to the Accounting Firm. The determination of the amount of Homology Net Cash made by the Accounting Firm shall be made in writing delivered to each of Homology and Q32, shall be final and binding on Homology and Q32 and shall be deemed to have been finally determined for purposes of this Agreement and to represent the Final Homology Net Cash for purposes of this Agreement. The Parties shall delay the Closing until the resolution of the matters described in this Section 2.8(e). The fees and expenses of the Accounting Firm shall be allocated between Homology and Q32 in the same proportion that the disputed amount of the Homology Net Cash that was unsuccessfully disputed by such Party (as finally determined by the Accounting Firm) bears to the total disputed amount of the Homology Net Cash amount and such portion of the costs and expenses of the Accounting Firm borne by Q32 and any other fees, costs or expenses incurred by Q32 following the Anticipated Closing Date in connection with the procedures set forth in this Section 2.8(e) shall be deducted from the final determination of the amount of Homology Net Cash. If this

 

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Section 2.8(e) applies as to the determination of the Final Homology Net Cash described in Section 2.8(a), upon resolution of the matter in accordance with this Section 2.8(e), the Parties shall not be required to determine Homology Net Cash again even though the Closing Date may occur later than the Anticipated Closing Date, except that either Homology and Q32 may require a redetermination of the Final Homology Net Cash if the Closing Date is more than ten (10) calendar days after the Anticipated Closing Date.

2.9 Further Action. If, at any time after the Effective Time, any further action is determined by the Surviving Corporation to be necessary or desirable to carry out the purposes of this Agreement or to vest the Surviving Corporation with full right, title and possession of and to all rights and property of Q32, then the officers and manager of the Surviving Corporation shall be fully authorized, and shall use their and its commercially reasonable efforts (in the name of Q32, in the name of Merger Sub, in the name of the Surviving Corporation and otherwise) to take such action.

2.10 Withholding. Each of the Exchange Agent, Homology and the Surviving Corporation (each, a “Withholding Agent”) shall be entitled to deduct and withhold from any consideration deliverable pursuant to this Agreement (including the Pre-Closing Distribution) such amounts as are required to be deducted or withheld from such consideration under the Code or under any other applicable Law; provided, however, that if a Withholding Agent determines that any payment in connection with the Contemplated Transactions is subject to deduction and/or withholding, then, except with respect to compensatory payments or as a result of a failure to deliver the certificate described in Section 5.16(b), such Withholding Agent shall use commercially reasonable efforts to (i) provide reasonable advance notice to such recipient of any required deduction or withholding and (ii) reasonably cooperate with such recipient to reduce or eliminate any such deduction and/or withholding. To the extent such amounts are so deducted or withheld, such amounts shall be (i) timely remitted to the appropriate Governmental Authority and (ii) treated for all purposes under this Agreement as having been paid to the Person to whom such amounts would otherwise have been paid.

ARTICLE III

REPRESENTATIONS AND WARRANTIES OF Q32

Except as set forth in the written disclosure schedule delivered by Q32 to Homology (the “Q32 Disclosure Schedule”), Q32 represents and warrants to Homology and Merger Sub as follows:

3.1 Due Organization; Subsidiaries.

(a) Q32 is a corporation or other legal entity duly incorporated or otherwise organized, validly existing and in good standing under the Laws of the jurisdiction of its incorporation or organization and has all necessary power and authority: (i) to conduct its business in the manner in which its business is currently being conducted, (ii) to own or lease and use its property and assets in the manner in which its property and assets are currently owned or leased and used and (iii) to perform its obligations under all Contracts by which it is bound.

(b) Each of Q32 and its Subsidiaries is licensed and qualified to do business, and is in good standing (to the extent applicable in such jurisdiction), under the Laws of all jurisdictions where the nature of its business in the manner in which its business is currently being conducted requires such licensing or qualification other than in jurisdictions where the failure to be so qualified individually or in the aggregate would not be reasonably expected to have a Q32 Material Adverse Effect.

(c) Except as set forth on Section 3.1(c) of the Q32 Disclosure Schedule, Q32 has no Subsidiaries and Q32 does not directly or indirectly own any capital stock of, or any equity ownership or profit sharing interest of any nature in, or control directly or indirectly, any other Entity. Q32 is not and has not otherwise been, directly or indirectly, a party to, member of or participant in any partnership, joint venture or similar business entity. Q32

 

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has not agreed and is not obligated to make, or is bound by any Contract under which it may become obligated to make, any future investment in or capital contribution to any other Entity. Q32 has not, at any time, been a general partner of, and has not otherwise been liable for any of the debts or other obligations of, any general partnership, limited partnership or other Entity.

3.2 Organizational Documents. Q32 has delivered to Homology accurate and complete copies of Q32’s Organizational Documents. Q32 is not in breach or violation of its Organizational Documents in any material respect.

3.3 Authority; Binding Nature of Agreement. Q32 has all necessary corporate power and authority to enter into and to perform its obligations under this Agreement and to consummate the Contemplated Transactions. The Q32 Board (at meetings duly called and held) has (i) determined that the Contemplated Transactions are fair to, advisable and in the best interests of Q32 and its stockholders, (ii) approved and declared advisable this Agreement and the Contemplated Transactions and (iii) determined to recommend the Q32 Board Recommendation to the stockholders of Q32. This Agreement has been duly executed and delivered by Q32 and assuming the due authorization, execution and delivery by Homology and Merger Sub, constitutes the legal, valid and binding obligation of Q32, enforceable against Q32 in accordance with its terms, subject to the Enforceability Exceptions.

3.4 Vote Required. The affirmative vote of the holders of at least (i) a majority of the then outstanding shares of Q32 Common Stock outstanding on the record date for the Q32 Stockholder Written Consent and (ii) a majority of the then outstanding shares of Q32 Preferred Stock voting as a single class on an as-converted basis (together, the “Required Q32 Stockholder Vote”), is the only vote of the holders of any class or series of Q32 Capital Stock necessary to adopt and approve this Agreement and approve the Contemplated Transactions. No interest in Q32 is subject to any appraisal or dissenters rights in connection with the Contemplated Transactions.

3.5 Non-Contravention; Consents.

(a) Subject to obtaining the Required Q32 Stockholder Vote and the filing of the Certificate of Merger required by Delaware Law, neither (x) the execution, delivery or performance of this Agreement by Q32, nor (y) the consummation of the Contemplated Transactions, will directly or indirectly (with or without notice or lapse of time):

(i) contravene, conflict with or result in a violation of any of the provisions of the Organizational Documents of Q32 or its Subsidiaries;

(ii) contravene, conflict with or result in a material violation of, or give any Governmental Authority or other Person the right to challenge the Contemplated Transactions or to exercise any remedy or obtain any relief under, any Law or any Order to which Q32 or its Subsidiaries, or any of the assets owned or used by Q32 or its Subsidiaries, is subject;

(iii) contravene, conflict with or result in a material violation of any of the terms or requirements of, or give any Governmental Authority the right to revoke, withdraw, suspend, cancel, terminate or modify, any Governmental Authorization that is held by Q32 or its Subsidiaries or that otherwise relates to the business of Q32, or any of the assets owned, leased or used by Q32;

(iv) contravene, conflict with or result in a violation or breach of, or result in a default under, any provision of any Q32 Material Contract, or give any Person the right to: (A) declare a default or exercise any remedy under any Q32 Material Contract, (B) any material payment, rebate, chargeback, penalty or change in delivery schedule under any such Q32 Material Contract, (C) accelerate the maturity or performance of any Q32 Material Contract or (D) cancel, terminate or modify any term of any Q32 Material Contract, except in the case of any nonmaterial breach, default, penalty or modification; or

(v) result in the imposition or creation of any Encumbrance upon or with respect to any asset owned or used by Q32 or its Subsidiaries (except for Permitted Encumbrances).

 

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(b) Except for (i) any Consent set forth on Section 3.5 of the Q32 Disclosure Schedule under any Q32 Contract, (ii) the Required Q32 Stockholder Vote, (iii) the filing of the Certificate of Merger with the Secretary of State of the State of Delaware pursuant to Delaware Law and (iv) such consents, waivers, approvals, orders, authorizations, registrations, declarations and filings as may be required under applicable federal and state securities laws, neither Q32 nor any of its Subsidiaries was, is or will be required to make any filing with or give any notice to, or to obtain any Consent from, any Person in connection with (x) the execution, delivery or performance of this Agreement or (y) the consummation of the Contemplated Transactions.

(c) The Q32 Board has taken and will take all actions necessary to ensure that the restrictions applicable to business combinations contained in Section 203 of Delaware Law are, and will be, inapplicable to the execution, delivery and performance of this Agreement and to the consummation of the Contemplated Transactions. No other state takeover statute or similar Law applies or purports to apply to the Merger, this Agreement or any of the other Contemplated Transactions.

3.6 Capitalization.

(a) The authorized capital stock of Q32 consists of (i) 141,900,000 shares of Q32 Common Stock of which 7,274,482 shares have been issued and are outstanding as of November 12, 2023 , and (ii) 117,933,356 shares of Q32 Preferred Stock of which (a) 6,500,000 shares have been designated Q32 Series A1 Preferred Stock of which 6,500,000 shares have been issued and are outstanding as of November 12, 2023, (b) 47,628,788 shares have been designated Q32 Series A Preferred Stock of which 47,628,788 shares have been issued and are outstanding as of November 12, 2023 and (d) 63,804,568 shares have been designated Q32 Series B Preferred Stock of which 54,689,627 shares have been issued and are outstanding as of November 12, 2023. Q32 does not hold any shares of its capital stock in its treasury.

(b) All of the outstanding shares of Q32 Common Stock have been duly authorized and validly issued, and are fully paid and nonassessable and are free of any Encumbrances other than under applicable securities Laws. None of the outstanding shares of Q32 Common Stock is entitled or subject to any preemptive right, right of participation, right of maintenance or any similar right. None of the outstanding shares of Q32 Common Stock is subject to any right of first refusal in favor of Q32. Except as contemplated herein, there is no Q32 Contract relating to the voting or registration of, or restricting any Person from purchasing, selling, pledging or otherwise disposing of (or granting any option or similar right with respect to), any shares of Q32 Common Stock. Q32 is not under any obligation, nor is Q32 bound by any Contract pursuant to which it may become obligated, to repurchase, redeem or otherwise acquire any outstanding shares of Q32 Common Stock or other securities. Section (b) of the Q32 Disclosure Schedule accurately and completely describes all repurchase rights held by Q32 with respect to shares of Q32 Common Stock (including shares issued pursuant to the exercise of stock options) and specifies which of those repurchase rights are currently exercisable.

(c) Except for the Q32 Equity Plan and the Q32 Options granted thereunder, Q32 does not have any stock incentive plan or any other plan, program, agreement or arrangement providing for any equity or equity-based compensation for any Person and there were no other equity or equity-based awards outstanding as of the date of this Agreement. As of the date of this Agreement, Q32 has reserved 25,956,535 shares of Q32 Common Stock for issuance under the Q32 Equity Plan, of which 24,450,104 shares have been issued and are outstanding pursuant to the exercise of Q32 Options, 24,336,980 shares are subject to outstanding Q32 Options, and 97,505 shares remain available for future grant pursuant to the Q32 Equity Plan. Section 3.6(c) of the Q32 Disclosure Schedule sets forth a true and complete list, as of the date of this Agreement, of each outstanding Q32 Option, including: (i) the name of the holder, (ii) the number of shares of Q32 Common Stock subject to such Q32 Option, (iii) the exercise price of each Q32 Option, (iv) the date on which such Q32 Option, (v) the applicable vesting schedule, including any acceleration provisions, and the number of vested and unvested shares, (vi) the expiration date, as applicable, and (vii) whether the Q32 Option is intended to be an “incentive stock option” (as defined in the Code) or a non-qualified stock option. Q32 has made available to Homology accurate and complete copies of the following: (A) the standard form of agreement evidencing Q32 Options; and (B) each

 

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agreement evidencing a Q32 Option that does not conform in all material respects to the standard form agreement.

(d) Except as set forth on Section 3.6(c) of the Q32 Disclosure Schedule, there is no: (i) outstanding subscription, option, call, warrant or right (whether or not currently exercisable) to acquire any shares of the capital stock or other securities of Q32, (ii) outstanding security, instrument or obligation that is or may become convertible into or exchangeable for any shares of the capital stock or other securities of Q32, (iii) stockholder rights plan (or similar plan commonly referred to as a “poison pill”) or Contract under which Q32 is or may become obligated to sell or otherwise issue any shares of its capital stock or any other securities or (iv) condition or circumstance that may give rise to or provide a basis for the assertion of a claim by any Person to the effect that such Person is entitled to acquire or receive any shares of capital stock or other securities of Q32.

(e) All outstanding shares of Q32 Common Stock, and other securities of Q32 have been issued and granted in compliance with (i) all applicable securities laws and other applicable Law and (ii) all requirements set forth in applicable Contracts.

3.7 Financial Statements.

(a) Section 3.7(a) of the Q32 Disclosure Schedule includes true and complete copies of (i) the Q32 Balance Sheet and the related audited estimated statement of income, cash flow and changes in partners’ capital for the years ended December 31, 2021 and December 31, 2022 (the “Q32 Audited Financial Statements”), and (ii) Q32’s unaudited balance sheet and the related unaudited estimated statement of income, cash flow and changes in partners’ capital for the three and six (6) months ended June 30, 2023 (the “Q32 Interim Financial Statements” and collectively, with the Q32 Audited Financial Statements, the “Q32 Financial Statements”).

(b) The Q32 Financial Statements (i) were prepared in accordance with GAAP (except the Q32 Interim Financial Statements and are subject to normal and recurring year-end adjustments that are not reasonably expected to be material in amount) applied on a consistent basis unless otherwise noted therein throughout the periods indicated, (ii) fairly present, in all material respects, the financial position of Q32 as of the respective dates thereof and the results of operations and cash flows of Q32 for the periods covered thereby and (iii) when delivered by Q32 for inclusion in the Registration Statement (as defined below) for filing with the SEC following the date of this Agreement in accordance with Section 5.7, shall comply in all material respects with the applicable accounting requirements and with the rules and regulations of the SEC, the Exchange Act and the Securities Act applicable to a registrant, in effect as of the respective dates thereof. Other than as expressly disclosed in the Q32 Financial Statements, there has been no material change in Q32’s accounting methods or principles that would be required to be disclosed in Q32’s financial statements in accordance with GAAP. The books of account and other financial records of Q32 and each of its Subsidiaries are true and complete in all material respects.

(c) There have been no formal internal investigations regarding financial reporting or accounting policies and practices discussed with, reviewed by or initiated at the direction of the chief executive officer, chief financial officer, or general counsel of Q32, the Q32 Board or any committee thereof, other than ordinary course audits or reviews of accounting policies and practices or internal controls.

(d) Q32 and its Subsidiaries maintains a system of internal accounting controls designed to provide reasonable assurance that: (i) transactions are executed in accordance with management’s general or specific authorizations, (ii) transactions are recorded as necessary to permit preparation of the financial statements of Q32 and its Subsidiaries in conformity with GAAP and to maintain accountability of the Company’s and its Subsidiaries’ assets, (iii) access to Q32’s and its Subsidiaries’ assets is permitted only in accordance with management’s general or specific authorization and (iv) the recorded accountability for Q32 and its Subsidiaries’ assets is compared with the existing assets at regular intervals and appropriate action is taken with respect to any differences. Q32 and each of its Subsidiaries maintains internal control over financial reporting that provides

 

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reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP.

(e) Q32’s auditor has at all times since the date of enactment of the Sarbanes-Oxley Act been: (i) a registered public accounting firm (as defined in Section 2(a)(12) of the Sarbanes-Oxley Act), (ii) to the Knowledge of Q32, “independent” with respect to Q32 within the meaning of Regulation S-X under the Exchange Act and (iii) to the Knowledge of Q32, in compliance with subsections (g) through (l) of Section 10A of the Exchange Act and the rules and regulations promulgated by the SEC and the Public Company Accounting Oversight Board (“PCAOB”) thereunder (such firm, the “PCAOB Auditor”).

3.8 Absence of Changes. Except as set forth on Section 3.8 of the Q32 Disclosure Schedule, since January 1, 2022, Q32 and its Subsidiaries have conducted their business only in the Ordinary Course of Business (except for the execution and performance of this Agreement and the discussions, negotiations and transactions related thereto) and there has not been any (a) Q32 Material Adverse Effect or (b) action, event or occurrence that would have required consent of Homology pursuant to Section 5.1 of this Agreement had such action, event or occurrence taken place after the execution and delivery of this Agreement.

3.9 Absence of Undisclosed Liabilities. Neither Q32 nor any of its Subsidiaries has any liability, indebtedness, obligation, expense, claim, deficiency, guaranty or endorsement of any kind, whether accrued, absolute, contingent, matured, unmatured or otherwise (each a “Liability”), in each case, of a type required to be reflected or reserved for on a balance sheet prepared in accordance with GAAP, except for: (a) Liabilities disclosed, reflected or reserved against in the Q32 Balance Sheet, (b) normal and recurring current Liabilities that have been incurred by Q32 or its Subsidiaries since the date of the Q32 Balance Sheet in the Ordinary Course of Business (none of which relates to any breach of contract, breach of warranty, tort, infringement, or violation of Law), (c) Liabilities for performance of obligations of Q32 or any of its Subsidiaries under Q32 Contracts, (d) Liabilities incurred in connection with the Contemplated Transactions and (e) Liabilities described in Section 3.9 of the Q32 Disclosure Schedule.

3.10 Title to Assets. Each of Q32 and its Subsidiaries has good and valid title to, or, in the case of leased properties and assets, valid leasehold interests in, all tangible properties or tangible assets and equipment used or held for use in its business or operations or purported to be owned by it, including: (a) all tangible assets reflected on the Q32 Balance Sheet and (b) all other tangible assets reflected in the books and records of Q32 as being owned by Q32. All of such assets are owned or, in the case of leased assets, leased by Q32 or any of its Subsidiaries free and clear of any Encumbrances, other than Permitted Encumbrances.

3.11 Real Property; Leasehold. Neither Q32 nor any of its Subsidiaries owns or has ever owned any real property. Q32 has made available to Homology (a) an accurate and complete list of all real properties with respect to which Q32 directly or indirectly holds a valid leasehold interest as well as any other real estate that is in the possession of or leased by Q32 or any of its Subsidiaries and (b) copies of all leases under which any such real property is possessed (the “Q32 Real Estate Leases”), each of which is in full force and effect, with no existing material default thereunder.

3.12 Intellectual Property.

(a) Section 3.12(a) of the Q32 Disclosure Schedule is an accurate, true and complete listing of all Q32 Registered IP, including for each item (i) the record owner (and name of any other Person with an ownership interest in such item of Q32 Registered IP, if any), jurisdiction (or, with respect to domain names, the applicable registrar), status, date and registration or application number of each item, as applicable, (ii) the name of the record owner and any other Person that has an ownership interest in such item of Q32 Registered IP, and the nature of such ownership interest, and (iii) any actions that are required to be taken within 180 days of the date hereof for any Q32 Registered IP, including the payment of any registration, maintenance or renewal fees or the filing of or response to any documents, applications or certificates, for the purposes of prosecuting, obtaining,

 

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perfecting, maintaining or renewing any Q32 Registered IP. Section 3.12(a) of the Q32 Disclosure Schedule also sets forth, as of the date of this Agreement, a list of all internet domain names with respect to which Q32 or any of its Subsidiaries are the registrant and, with respect to each domain name, the record owner of such domain name and if different, the legal and beneficial owner(s) of such domain name and the applicable domain name registrar.

(b) Section 3.12(b) of the Q32 Disclosure Schedule accurately identifies all Q32 Contracts pursuant to which any material Q32 IP Rights are licensed to Q32 (other than (A) any non-customized software that (1) is so licensed solely in executable or object code form pursuant to a nonexclusive, internal use software license and other Intellectual Property associated with such software and (2) is not incorporated into, or material to the development, manufacturing, or distribution of, any of Q32’s or its Subsidiaries’ products or services, (B) any Intellectual Property licensed on a nonexclusive basis ancillary to the purchase or use of equipment, reagents or other materials, (C) any confidential information provided under confidentiality agreements and (D) agreements between Q32 or its Subsidiaries and their respective employees in Q32’s standard form thereof). To the Knowledge of Q32, each Q32 Contract listed in Section 3.12(b) of the Q32 Disclosure Schedule is in full force and effect and constitutes a legal, valid, and binding obligation of Q32, its Subsidiaries and each other party thereto, and is enforceable against Q32, its Subsidiaries and each other party thereto in accordance with its terms. To the Knowledge of Q32, neither Q32, its Subsidiaries, nor any other party to any Q32 Contract listed in Section 3.12(b) of the Q32 Disclosure Schedule has been or is, or has been or is alleged to be, in material default under, or has provided or received any notice of breach under, or intention to terminate (including by non-renewal), any Q32 Contract listed in Section 3.12(b) of the Q32 Disclosure Schedule, except as would not reasonably be expected to have, individually or in the aggregate, a Q32 Material Adverse Effect.

(c) Except for instances that would not reasonably be expected to have, individually or in the aggregate, a Q32 Material Adverse Effect, Section 3.12(c) of the Q32 Disclosure Schedule accurately identifies each Q32 Contract pursuant to which any Person has been granted any license under, or otherwise has received or acquired any right (whether or not currently exercisable) or interest in, any Q32 IP Rights (other than (i) any confidential information provided under confidentiality agreements and (ii) any Q32 IP Rights nonexclusively licensed to academic collaborators, suppliers or service providers for the sole purpose of enabling such academic collaborator, supplier or service providers to provide services for Q32’s or its Subsidiaries’ benefit). To the Knowledge of Q32, each Q32 Contract listed in Section 3.12(c) of the Q32 Disclosure Schedule is in full force and effect and constitutes a legal, valid, and binding obligation of Q32, its Subsidiaries and each other party thereto, and is enforceable against Q32, its Subsidiaries and each other party thereto in accordance with its terms. Neither Q32, its Subsidiaries nor, to the Knowledge of Q32, any other party to any Q32 Contract listed in Section 3.12(c) of the Q32 Disclosure Schedule has provided or received any written notice or allegation of breach under, or intention to terminate (including by non-renewal), any Q32 Contract listed in Section 3.12(c) of the Q32 Disclosure Schedule.

(d) Except as identified on Section 3.12(d) of the Q32 Disclosure Schedule, neither Q32 nor any of its Subsidiaries is bound by, no Q32 Owned IP Rights are subject to, and to the Knowledge of Q32, no Q32 Licensed IP Rights are subject to (other than the rights of the applicable licensors), any Contract containing any covenant or other provision that in any way limits or restricts the ability of Q32 or any of its Subsidiaries to use, exploit, assert, or enforce any Q32 IP Rights anywhere in the world, except as would not reasonably be expected to have, individually or in the aggregate, a Q32 Material Adverse Effect.

(e) Q32 or one of its Subsidiaries exclusively owns all right, title, and interest to and in the Q32 IP Rights (other than (i) Q32 Licensed IP Rights, or co-owned rights each as identified in Section 3.12(b) of the Q32 Disclosure Schedule, (ii) any non-customized software that (A) is licensed to Q32 or its Subsidiaries solely in executable or object code form pursuant to a nonexclusive, internal use software license and other Intellectual Property associated with such software and (B) is not incorporated into, or material to the development, manufacturing, or distribution of, any of Q32’s or its Subsidiaries’ products or services and (iii) any Intellectual Property licensed on a nonexclusive basis ancillary to the purchase or use of equipment, reagents or other materials), in each case, free and clear of any Encumbrances (other than Permitted Encumbrances).

 

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(f) To the Knowledge of Q32, (i) all documents and instruments necessary to register or apply for or renew registration of Q32 Registered IP owned by Q32, and (ii) all documents and instruments necessary to register or apply for or renew registration of Q32 Registered IP exclusively licensed to Q32, have been validly executed, delivered, and filed in a timely manner with the appropriate Governmental Authority. To the Knowledge of Q32, (i) Q32 has filed all statements of use and paid all renewal and maintenance fees, annuities and other fees with respect to the Q32 Registered IP owned by Q32 and (ii) Q32 has executed all documents and instruments necessary to register or apply for or renew registration of Q32 Registered IP exclusively licensed to Q32, in each case (i) and (ii), that are due and payable as of the date of this Agreement.

(g) Except for instances that would not reasonably be expected to have, individually or in the aggregate, a Q32 Material Adverse Effect, to the Knowledge of Q32 each Person who is or was an employee, contractor or consultant of Q32 or any of its Subsidiaries and who is or was involved in the creation, discovery, reduction to practice or development of any Intellectual Property for Q32 or any of its Subsidiaries has signed a valid, enforceable written agreement containing a present assignment of all right, title and interest in and to such Intellectual Property to Q32 or such Subsidiary and confidentiality provisions protecting trade secrets and confidential information of Q32 and its Subsidiaries.

(h) To the Knowledge of Q32, no current or former member, officer, director, or employee of Q32 or any of its Subsidiaries has any claim, right (whether or not currently exercisable), or interest to or in any Q32 IP Rights purported to be owned by Q32. To the Knowledge of Q32, no employee of Q32 or any of its Subsidiaries is (A) bound by or otherwise subject to any Contract restricting him or her from performing his or her duties for Q32 or such Subsidiary or (B) in breach of any Contract with any former employer or other Person concerning Q32 IP Rights purported to be owned by Q32 or such Subsidiary or confidentiality provisions protecting trade secrets and confidential information comprising Q32 IP Rights purported to be owned by Q32 or such Subsidiary.

(i) Except as set forth on Section 3.12(i) of the Q32 Disclosure Schedule, no funding, facilities, or personnel of any Governmental Authority were used, directly or indirectly, to develop or create, in whole or in part, any Q32 Owned IP Rights, or, to the Knowledge of Q32, any Q32 Licensed IP Rights, and no educational institution has any right to, or right to royalties for, or to impose any requirement on the manufacture or commercialization of any product incorporating, any Q32 Owned IP Rights, or, to the Knowledge of Q32, any Q32 Licensed IP Rights. To the Knowledge of Q32, no Governmental Authority has any right to (including any “step-in” or “march-in” rights with respect to), ownership of, commercialization of, or right to royalties or other payments for any Q32 Owned IP Rights, or, to the Knowledge of Q32, any Q32 Licensed IP Rights. Without limiting the generality of the foregoing, to the Knowledge of Q32, no invention claimed or covered by any Patent within the Q32 Owned IP Rights, or, to the Knowledge of Q32, any Q32 Licensed IP Rights, (A) was conceived or reduced to practice in connection with any research activities funded, in whole or in part, by the federal government of the United States or any agency thereof, (B) is a “subject invention” as that term is described in 35 U.S.C. Section 201(e), or (C) is otherwise subject to the provisions of the Bayh-Dole Act or any similar Law of any other jurisdiction, including with respect to any Patents that are part of the Q32 IP Rights.

(j) Q32 and each of its Subsidiaries has taken reasonable steps to maintain the confidentiality of and otherwise protect, maintain and enforce its rights in all proprietary information that Q32 or such Subsidiary holds, or purports to hold, as confidential or a trade secret. To the Knowledge of Q32, neither Q32 nor any of its Subsidiaries has made any of its trade secrets or other material confidential or proprietary information that it intended to maintain as confidential information available to any other Person except pursuant to written agreements requiring such Person to maintain the confidentiality of such trade secrets or confidential information. To the Knowledge of Q32, there have been no material security breaches, outages, violations or unauthorized access to any of the proprietary information that Q32 or any of its Subsidiaries holds, or purports to hold, as confidential or a trade secret, except as would not reasonably be expected to have, individually or in the aggregate, a Q32 Material Adverse Effect.

 

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(k) Except as set forth on Section 3.12(k) of the Q32 Disclosure Schedule, neither Q32 nor any of its Subsidiaries has assigned or otherwise transferred ownership of, or agreed to assign or otherwise transfer ownership of, any Q32 IP Rights to any other Person.

(l) To the Knowledge of Q32, neither Q32 nor any of its Subsidiaries has taken or failed to take any action that could be reasonably expected to result in the abandonment, invalidity, cancellation, forfeiture, relinquishing, invalidation or unenforceability of any Q32 IP Rights (including with respect to any trademark, a failure to exercise adequate quality controls or an assignment in gross without the accompanying goodwill). To the Knowledge of Q32, each item of Q32 IP Right has been duly maintained and is not expired, abandoned or cancelled. To the Knowledge of Q32, each of the Patents included in the Q32 IP Rights identifies each and every inventor of the claims thereof as determined in accordance with the applicable laws of the jurisdiction in which such Patent is issued or pending. To the Knowledge of Q32, neither Q32 nor any of its Subsidiaries has engaged in patent or copyright misuse or any fraud or inequitable conduct in connection with any Q32 IP Right. To the Knowledge of Q32, each of Q32 and its Subsidiaries and their respective patent counsel have complied with its duty of candor and disclosure and have made no material misrepresentations in the filings submitted to the applicable Governmental Authorities with respect to all Patents included in the Q32 IP Rights for which Q32 or any of its Subsidiaries is responsible for prosecuting.

(m) To the Knowledge of Q32, the Q32 IP Rights constitute all Intellectual Property necessary for Q32 to conduct its business as currently conducted or proposed to be conducted; provided, however, that the foregoing representation is not a representation with respect to non-infringement of Intellectual Property.

(n) Q32 has delivered, or made available to Homology, a complete and accurate copy of all material Q32 IP Rights Agreements.

(o) To the Knowledge of Q32, the manufacture, marketing, offering for sale, sale, importation, use or intended use or other disposal of any product as currently sold or under development by Q32 does not violate any license or agreement between Q32 or its Subsidiaries and any third party in any material respect, and, to the Knowledge of Q32, does not infringe or misappropriate any valid and issued Patent or other Intellectual Property of any other Person, which infringement or misappropriation would reasonably be expected to have a Q32 Material Adverse Effect. To the Knowledge of Q32, no third party is infringing upon any Patents owned by Q32 within the Q32 IP Rights, or otherwise violating any Q32 IP Rights Agreement.

(p) Except as set forth on Section 3.12(p) of the Q32 Disclosure Schedule, as of the date of this Agreement, neither Q32 nor any of its Subsidiaries is a party to any Legal Proceeding (including, but not limited to, opposition, interference or other proceeding in any patent or other government office) contesting the validity, ownership or right to use, sell, offer for sale, license or dispose of any Q32 IP Rights. None of the Q32 Owned IP Rights, and to the Knowledge of Q32, none of the Q32 Licensed IP rights, have been adjudged invalid or unenforceable in whole or part, and all Q32 Owned IP Rights, and to the Knowledge of Q32, all Q32 Licensed IP rights, are in full force and effect. No Patents within the Q32 Registered IP owned by Q32, or to the Knowledge of Q32, no Patents within the Q32 Registered IP exclusively licensed to Q32, have been subject to any interference, derivation, reexamination (including ex parte reexamination, inter partes reexamination, inter partes review, or post grant review), reissue, cancellation, opposition, claim, allegation or other action, including any proceeding in which the scope, validity, inventorship, ownership or enforceability of any such Patent is being, has been, or could reasonably be expected to be, contested or challenged. Neither Q32 nor any of its Subsidiaries have received any written notice asserting that any Q32 IP Rights or the proposed use, sale, offer for sale, license or disposition of products, methods, or processes claimed or covered thereunder infringes or misappropriates or violates the rights of any other Person or that Q32 or any of its Subsidiaries have otherwise infringed, misappropriated or otherwise violated any Intellectual Property of any Person.

(q) Except as set forth on Section 3.12(q) of the Q32 Disclosure Schedule, to the Knowledge of Q32, no trademark (whether registered or unregistered) or trade name owned, used, or applied for by Q32 conflicts or

 

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interferes with any trademark (whether registered or unregistered) or trade name owned, used, or applied for by any other Person except as would not have a Q32 Material Adverse Effect. To the Knowledge of Q32, none of the goodwill associated with or inherent in any trademark (whether registered or unregistered) in which Q32 or its Subsidiaries has or purports to have an ownership interest has been impaired as determined by Q32 in accordance with GAAP. Section 3.12(q) of the Q32 Disclosure Schedule sets forth all material unregistered trademarks included in the Q32 IP Rights.

(r) Except (i) as would reasonably not be expected to have a Q32 Material Adverse Effect, (ii) as may be set forth in Sections 3.12(a) or 3.12(b) of the Q32 Disclosure Schedule or (iii) as contained in license, distribution or service agreements entered into in the Ordinary Course of Business by Q32, to the Knowledge of Q32, (A) neither Q32 nor any of its Subsidiaries is bound by any Contract to indemnify, defend, hold harmless, or reimburse any other Person with respect to any Intellectual Property infringement, misappropriation, or similar claim which is material to Q32 or any of its Subsidiaries, taken as a whole and (B) neither Q32 nor any of its Subsidiaries has ever assumed, or agreed to discharge or otherwise take responsibility for, any existing or potential liability of another Person for infringement, misappropriation, or violation of any Intellectual Property right, which assumption, agreement or responsibility remains in force as of the date of this Agreement.

(s) To the Knowledge of Q32, neither Q32 nor any of its Subsidiaries is party to any Contract that, as a result of such execution, delivery and performance of this Agreement, will (i) cause the grant, assignment, or transfer to any other third party of any license or other right to or in any Q32 IP Rights, (ii) result in breach of, default under, termination of, or acceleration or modification of such Contract with respect to any Q32 IP Rights, (iii) alter, encumber, impair or extinguish, or result in any Encumbrance with respect to the right of Q32 or the Surviving Corporation and its Subsidiaries to use, sell or license or enforce any Q32 IP Rights or portion thereof, or (iv) result in Q32 or any of its Subsidiaries being bound by or subject to any exclusivity obligations, non-compete or other restrictions on the operation or scope of their respective businesses, or to any obligation to grant any rights in or to any Q32 IP Rights, except, in each of (i), (ii), (iii) and (iv), for the occurrence of any such grant or impairment that would not individually or in the aggregate, reasonably be expected to result in a Q32 Material Adverse Effect.

3.13 Agreements, Contracts and Commitments.

(a) Section 3.13(a) of the Q32 Disclosure Schedule lists the following Q32 Contracts in effect as of the date of this Agreement (each, a “Q32 Material Contract” and collectively, the “Q32 Material Contracts”):

(i) each Q32 Contract that is a collective bargaining agreement or other agreement or arrangement with any labor union, works council or labor organization;

(ii) each Q32 Contract for the employment or engagement of any individual on an employee, consulting or other basis that provides for annual base compensation in excess of $200,000;

(iii) each Q32 Contract with any Q32 Associate that provides for retention, change in control, transaction or other similar payments or benefits, whether or not payable as a result of the Contemplated Transactions;

(iv) each Q32 Contract relating to any agreement of indemnification or guaranty not entered into in the Ordinary Course of Business;

(v) each Q32 Contract containing (A) any covenant limiting the freedom of Q32 or any of its Subsidiaries or the Surviving Corporation to engage in any line of business or compete with any Person, or limiting the development, manufacture, or distribution of Q32’s products or services, (B) any most-favored pricing arrangement, (C) any exclusivity provision or (D) any non-solicitation provision;

(vi) each Q32 Contract (A) pursuant to which any Person granted Q32 an exclusive license under any Intellectual Property, or (B) pursuant to which Q32 granted any Person an exclusive license under any Q32 IP Rights;

 

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(vii) each Q32 Contract relating to capital expenditures and requiring payments after the date of this Agreement in excess of $500,000 pursuant to its express terms and not cancelable without penalty;

(viii) each Q32 Contract relating to the disposition or acquisition of material assets or any ownership interest in any Entity, in each case, involving payments in excess of $250,000 after the date of this Agreement;

(ix) each Q32 Contract relating to any mortgages, indentures, loans, notes or credit agreements, security agreements or other agreements or instruments relating to the borrowing of money or extension of credit in excess of $500,000 or creating any material Encumbrances with respect to any assets of Q32 or any loans or debt obligations with officers or directors of Q32;

(x) each Q32 Contract requiring payment by or to Q32 after the date of this Agreement in excess of $500,000 pursuant to its express terms relating to: (A) any distribution agreement (identifying any that contain exclusivity provisions), (B) any agreement involving provision of services or products with respect to any pre-clinical or clinical development activities of Q32, (C) any dealer, distributor, joint marketing, alliance, joint venture, cooperation, development or other agreement currently in force under which Q32 or any of its Subsidiaries has continuing obligations to develop or market any product, technology or service, or any agreement pursuant to which Q32 or any of its Subsidiaries has continuing obligations to develop any Intellectual Property that will not be owned, in whole or in part, by Q32 or such Subsidiary or (D) any Contract to license any Patent, trademark registration, service mark registration, trade name or copyright registration to or from any third party to manufacture or produce any product, service or technology of Q32 or any of its Subsidiaries or any Contract to sell, distribute or commercialize any products or service of Q32 or any of its Subsidiaries, in each case, except for Q32 Contracts entered into in the Ordinary Course of Business;

(xi) each Q32 Contract with any Person, including any financial advisor, broker, finder, investment banker or other Person, providing advisory services to Q32 in connection with the Contemplated Transactions;

(xii) each Q32 Contract to which Q32 or any of its Subsidiaries is a party or by which any of their assets and properties is currently bound, which involves annual obligations of payment by, or annual payments to, Q32 or such Subsidiary in excess of $500,000;

(xiii) a Q32 Real Estate Lease;

(xiv) a Contract disclosed in or required to be disclosed in Section 3.12(a) or Section 3.12(b) of the Q32 Disclosure Schedule; or

(xv) any other Q32 Contract that is not terminable at will (with no penalty or payment) by Q32 or any of its Subsidiaries, and (A) which involves payment or receipt by Q32 or such Subsidiary after the date of this Agreement under any such agreement, contract or commitment of more than $500,000 in the aggregate, or obligations after the date of this Agreement in excess of $1,000,000 in the aggregate or (B) that is material to the business or operations of Q32 and its Subsidiaries taken as a whole.

(b) Q32 has delivered or made available to Homology accurate and complete copies of all Q32 Material Contracts, including all amendments thereto. There are no Q32 Material Contracts that are not in written form. Q32 has not, nor to Q32’s Knowledge, as of the date of this Agreement, has any other party to a Q32 Material Contract, breached, violated or defaulted under, or received notice that it breached, violated or defaulted under, any of the terms or conditions of any Q32 Material Contract in such manner as would permit any other party to cancel or terminate any such Q32 Material Contract, or would permit any other party to seek damages which would reasonably be expected to have a Q32 Material Adverse Effect. As to Q32 and its Subsidiaries, as of the date of this Agreement, each Q32 Material Contract is valid, binding, enforceable and in full force and effect, subject to the Enforceability Exceptions. No Person is renegotiating, or has a right pursuant to the terms of any Q32 Material Contract to change, any material amount paid or payable to Q32 under any Q32 Material Contract or any other material term or provision of any Q32 Material Contract.

 

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3.14 Compliance; Permits; Restrictions.

(a) Q32 and each of its Subsidiaries is, and since January 1, 2020 has been, in material compliance with all applicable Laws. No investigation, claim, suit, proceeding, audit, Order, or other action by any Governmental Authority is pending or, to the Knowledge of Q32, threatened against Q32 or any of its Subsidiaries. There is no agreement or Order binding upon Q32 or any of its Subsidiaries which (i) has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Q32 or any of its Subsidiaries, any acquisition of material property by Q32 or any of its Subsidiaries or the conduct of business by Q32 or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Q32’s ability to comply with or perform any covenant or obligation under this Agreement or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.

(b) Each of Q32 and its Subsidiaries holds all required Governmental Authorizations that are material to the operation of the business of Q32 as currently conducted (collectively, the “Q32 Permits”). Section 3.14(b) of the Q32 Disclosure Schedule identifies each Q32 Permit. Each of Q32 and its Subsidiaries is in material compliance with the terms of Q32 Permits. No Legal Proceeding is pending or, to the Knowledge of Q32, threatened, which seeks to revoke, substantially limit, suspend, or materially modify any Q32 Permit.

(c) There are no Legal Proceedings pending or, to the Knowledge of Q32, threatened in writing with respect to an alleged material violation by Q32 or any of its Subsidiaries of the Federal Food, Drug, and Cosmetic Act (“FDCA”), the Public Health Service Act (“PHSA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substances Act or any other Law promulgated by the FDA or other Governmental Authority responsible for regulation of the research, development, testing, manufacturing, packaging, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of drug or biologic products (“Drug Regulatory Agency”).

(d) Each of Q32 and its Subsidiaries holds all required material Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Q32 as currently conducted, and, as applicable, the research, development, testing, manufacturing, packaging, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its product candidates (the “Q32 Product Candidates”) (collectively, the “Q32 Regulatory Permits”) and no such Q32 Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any material, adverse manner. Q32 has timely maintained and is in compliance in all material respects with the Q32 Regulatory Permits and neither Q32 nor any of its Subsidiaries has, since January 1, 2020, received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Q32 Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Q32 Regulatory Permit.

(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Q32 and its Subsidiaries, in which Q32 Product Candidates, have participated, were and, if still pending, are being conducted in compliance in all material respects with the applicable regulations of the Drug Regulatory Agencies and other applicable Law, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Neither Q32 nor any of its Subsidiaries has received any written notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to the Knowledge of Q32, any action to place a clinical hold order on, or otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, Q32 or any of its Subsidiaries or in which Q32 Product Candidates, have participated.

(f) Neither Q32 nor any of its Subsidiaries, and, to the Knowledge of Q32, any contract manufacturer with respect to any Q32 Product Candidate, is the subject of any pending or, to the Knowledge of Q32, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991)

 

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and any amendments thereto, or any other applicable Law. To the Knowledge of Q32, neither Q32 nor any of its Subsidiaries nor any contract manufacturer with respect to any Q32 Product Candidate has committed any acts, made any statement, or failed to make any statement, in each case in respect of Q32’s business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto, or any other applicable Law. None of Q32, any of its Subsidiaries, and to the Knowledge of Q32, any contract manufacturer with respect to any Q32 Product Candidate, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion under (i) 21 U.S.C. Section 335a, (ii) 42 U.S.C. § 1320a-7, or (iii) any other applicable Law. To the Knowledge of Q32, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Q32, any of its Subsidiaries, and to the Knowledge of Q32, any contract manufacturer with respect to any Q32 Product Candidate, or any of its respective officers, employees or agents. Neither Q32 nor any of its Subsidiaries is a party to or has any reporting obligations under any corporate integrity agreements, monitoring agreements, deferred or non-prosecution agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Authority.

(g) All manufacturing operations conducted by, or to the Knowledge of Q32, for the benefit of, Q32 or its Subsidiaries in connection with any Q32 Product Candidate, since January 1, 2020, have been and are being conducted in compliance in all material respects with applicable Laws, including the FDA’s standards for current good manufacturing practices, including applicable requirements contained in 21 C.F.R. Parts 210, 211 and 600-680 and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States.

(h) No laboratory or manufacturing site owned by Q32 or its Subsidiaries, and to the Knowledge of Q32, no manufacturing site of a contract manufacturer or laboratory, with respect to any Q32 Product Candidate, (i) is subject to a Drug Regulatory Agency shutdown or import or export prohibition or (ii) has since January 1, 2020 received any unresolved Form FDA 483, notice of violation, warning letter, untitled letter, or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting material noncompliance with any applicable Law, and, to the Knowledge of Q32, neither the FDA nor any other Governmental Authority is considering such action.

3.15 Legal Proceedings; Orders.

(a) There is no pending Legal Proceeding and, to the Knowledge of Q32, no Person has threatened in writing to commence any Legal Proceeding: (i) that involves Q32 or any of its Subsidiaries or any Q32 Associate (in his or her capacity as such) or any of the material assets owned or used by Q32 or any of its Subsidiaries or (ii) that challenges, or that may have the effect of preventing, delaying, making illegal or otherwise interfering with, the Contemplated Transactions.

(b) There is no Order to which Q32 or any of its Subsidiaries, or any of the material assets owned or used by Q32 or any of its Subsidiaries, is subject. To the Knowledge of Q32, no officer or other Key Employee of Q32 or any of its Subsidiaries is subject to any Order that prohibits such officer or employee from engaging in or continuing any conduct, activity or practice relating to the business of Q32 or any of its Subsidiaries or to any material assets owned or used by Q32 or any of its Subsidiaries.

3.16 Tax Matters.

(a) Each of Q32 and each of its Subsidiaries has timely filed all income Tax Returns and all other material Tax Returns that were required to be filed by or with respect to it under applicable Law. All such Tax Returns were correct and complete in all material respects and have been prepared in material compliance with all applicable Law. Subject to exceptions as would not be material, no claim has ever been made by a Governmental Authority in a jurisdiction where Q32 or any of its Subsidiaries does not file a particular type of Tax Return that

 

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Q32 or any of its Subsidiaries is subject to taxation by that jurisdiction that would require the filing of such a Tax Return.

(b) All material amounts of Taxes due and owing by Q32 and each of its Subsidiaries (whether or not shown on any Tax Return) have been timely paid. The unpaid Taxes of Q32 and each of its Subsidiaries for periods (or portions thereof) ending on or prior to the date of the Q32 Balance Sheet do not materially exceed the accruals for current Taxes set forth on the Q32 Balance Sheet. Since the date of the Q32 Balance Sheet, neither Q32 nor any of its Subsidiaries has incurred any material Liability for Taxes outside the Ordinary Course of Business or otherwise inconsistent with past custom and practice.

(c) Each of Q32 and each of its Subsidiaries has withheld and paid to the appropriate Governmental Authority all material Taxes required to have been withheld and paid in connection with any amounts paid or owing to any employee, independent contractor, creditor, stockholder, or other third party.

(d) There are no Encumbrances for material Taxes (other Encumbrances described in clause (i) of the definition of “Permitted Encumbrances”) upon any of the assets of Q32 or any of its Subsidiaries.

(e) No deficiencies for a material amount of Taxes with respect to Q32 or any of its Subsidiaries have been claimed, proposed or assessed by any Governmental Authority in writing that have not been timely paid in full. There are no pending (or, based on written notice, threatened) material audits, assessments, examinations or other actions for or relating to any Liability in respect of Taxes of Q32 or any of its Subsidiaries. Neither Q32 nor any of its Subsidiaries has waived any statute of limitations in respect of material Taxes or agreed to any extension of time with respect to a material Tax assessment or deficiency.

(f) Neither Q32 nor any of its Subsidiaries is a party to any Tax allocation, Tax sharing or similar agreement (including indemnity arrangements), other than customary indemnification provisions in commercial Contracts entered into in the Ordinary Course of Business with vendors, customers, lenders, or landlords (an “Ordinary Course Agreement”).

(g) Neither Q32 nor any of its Subsidiaries has been a member of an affiliated group filing a consolidated U.S. federal income Tax Return (other than a group the common parent of which is Q32). Neither Q32 nor any of its Subsidiaries has any material Liability for the Taxes of any Person (other than Q32) under Treasury Regulations Section 1.1502-6 (or any similar provision of state, local, or foreign law), as a transferee or successor, or by Contract (other than an Ordinary Course Agreement).

(h) Neither Q32 nor any of its Subsidiaries has distributed stock of another Person, or has had its stock distributed by another Person, in a transaction that was purported or intended to be governed in whole or in part by Section 355 of the Code or Section 361 of the Code.

(i) Neither Q32 nor any of its Subsidiaries has entered into any transaction identified as a “reportable transaction” for purposes of Treasury Regulations Section 1.6011-4(b)(2).

(j) Neither Q32 nor any of its Subsidiaries will be required to include any material item of income or gain in, or exclude any material item of deduction or loss from, taxable income for any taxable period (or portion thereof) ending after the Closing Date as a result of any: (i) change in, or use of improper, method of accounting for a taxable period ending on or prior to the Closing Date; (ii) “closing agreement” as described in Section 7121 of the Code (or any corresponding or similar provision of state, local or foreign income Tax law) executed on or prior to the Closing Date; (iii) installment sale or open transaction disposition made on or prior to the Closing Date; (iv) prepaid amount, advance payments or deferred revenue received or accrued on or prior to the Closing Date; or (v) intercompany transaction or excess loss amount described in Treasury Regulations under Section 1502 of the Code (or any corresponding or similar provision of state, local or foreign income Tax Law).

 

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(k) Section 3.16(k) of the Q32 Disclosure Schedule sets forth the entity classification of Q32 and each of its Subsidiaries for U.S. federal income tax purposes. Neither Q32 nor any of its Subsidiaries has made an election or taken any other action to change its federal and state income tax classification from such classification.

(l) Neither Q32 nor any of its Subsidiaries has taken or knowingly failed to take any action, nor to the Knowledge of Q32, are there any facts or circumstances, in each case, that would reasonably be expected to prevent or impede the Merger from qualifying for the Intended Tax Treatment.

3.17 Employee and Labor Matters; Benefit Plans.

(a) Section 3.17(a) of the Q32 Disclosure Schedule contains a complete and accurate list of all Q32 employees as of the date of this Agreement, setting forth for each employee: job title; classification as exempt or non-exempt for wage and hour purposes; annual base salary, hourly rate or other rates of compensation; bonus potential; full-time or part-time status; date of hire; business location; status (i.e., active or inactive and if inactive, the type of leave and estimated duration); and any visa or work permit status and the date of expiration, if applicable.

(b) Section 3.17(b) of the Q32 Disclosure Schedule contains a complete and accurate list as of the date hereof of all of the independent contractors, consultants, temporary employees, leased employees or other agents employed or used by Q32 and classified by Q32 as other than employees, or compensated other than through wages paid by Q32 through Q32’s payroll department (“Q32 Contingent Workers”), showing for each Q32 Contingent Worker such individual’s engagement date, role in the business, work location, and fee or compensation arrangements.

(c) Neither Q32 nor any of its Subsidiaries is a party to, bound by the terms of, or has a duty to bargain under, any collective bargaining agreement or other Contract with a labor union, works council or labor organization representing any Q32 Associate, and there are no labor unions, works council or labor organizations representing or, to the Knowledge of Q32, purporting to represent or seeking to represent any Q32 Associates, including through the filing of a petition for representation election.

(d) Section 3.17(d) of the Q32 Disclosure Schedule lists all material Q32 Employee Plans.

(e) As applicable with respect to each material Q32 Employee Plan, Q32 has made available to Homology, true and complete copies of (i) the plan document, including all amendments thereto, and in the case of an unwritten Employee Plan, a written description of all material terms thereof, (ii) all related trust instruments or other funding-related documents and insurance contracts, (iii) the summary plan description and each summary of material modifications thereto, (iv) the financial statements for the most recent year for which such financial statements are available (in audited form, if available or required by ERISA) and, where applicable, annual reports with any Governmental Authority (e.g., Form 5500 and all schedules thereto), (v) the most recent IRS determination or opinion letter, (vi) written results of any required compliance testing for the three most recent plan years, and (vii) all material, non-routine notices, filings or correspondence during the past three years with any Governmental Authority.

(f) Each Q32 Employee Plan that is intended to be qualified under Section 401(a) of the Code has received a favorable determination letter or may rely on a favorable opinion letter with respect to such qualified status from the IRS to the effect that such plan is qualified under Section 401(a) of the Code and the related trust is exempt from federal income Taxes under Section 501(a) of the Code. To the Knowledge of Q32, nothing has occurred that would reasonably be expected to cause the loss of the qualified status of any such Q32 Employee Plan or the Tax exempt status of any related trust.

(g) Each Q32 Employee Plan has been established, maintained and operated in compliance, in all material respects, with its terms and all applicable Laws, including, without limitation, the Code and ERISA. No Legal

 

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Proceeding (other than those relating to routine claims for benefits) is pending or, to the Knowledge of Q32, threatened with respect to any Q32 Employee Plan. All material payments and/or contributions required to have been made with respect to all Q32 Employee Plans have been made in accordance with the terms of the applicable Q32 Employee Plan and applicable Law in all material respects and neither Q32 nor any Q32 ERISA Affiliate has any material Liability for any such unpaid contributions with respect to any Q32 Employee Plan.

(h) Neither Q32, any of its Subsidiaries nor any of their ERISA Affiliates maintains, contributes to or is required to contribute to, or has any Liability with respect to (i) any “employee benefit plan” (within the meaning of Section 3(2) of ERISA) that is or was subject to Title IV or Section 302 of ERISA or Section 412 of the Code, (ii) a Multiemployer Plan, (iii) any Multiple Employer Plan, or (iv) any Multiple Employer Welfare Arrangement.

(i) No Q32 Employee Plan provides for medical or other welfare benefits to any service provider beyond termination of service or retirement, other than (i) pursuant to COBRA or an analogous state law requirement (the full cost of which is borne by such Person or such Person’s dependents or beneficiaries) or (ii) continuation coverage through the end of the month in which such termination or retirement occurs.

(j) No Q32 Employee Plan is subject to any law of a foreign jurisdiction outside of the United States.

(k) Each Q32 Employee Plan that constitutes in any part a nonqualified deferred compensation plan within the meaning of Section 409A of the Code has complied in all material respects with Section 409A of the Code, to the extent applicable, and no compensation has been or would reasonably be expected to be includable in the gross income of any Q32 Associate as a result of the operation of Section 409A of the Code.

(l) Q32 and its Subsidiaries are, and since January 1, 2020 have been, in compliance in all material respects with all applicable Laws respecting labor, employment and employment practices, including terms and conditions of employment, worker classification, tax withholding, unemployment compensation, workers’ compensation, prohibited discrimination, harassment, equal employment, fair employment practices, meal and rest periods, work authorization and immigration status, employee safety and health, wages (including overtime wages), pay equity, affirmative action, restrictive covenants, compensation, and hours of work. There are no Legal Proceedings pending or, to the Knowledge of Q32, threatened against Q32 or any of its Subsidiaries relating to any labor or employment matters or any Q32 Associate. Q32 is not a party to a conciliation agreement, consent decree or other agreement or Order with any federal, state, or local agency or Governmental Authority with respect to employment practices.

(m) Since January 1, 2020, (i) Q32 has not taken any action which would constitute a “plant closing”, “collective dismissal”, “group dismissal”, “group termination”, “mass termination”, or “mass layoff” within the meaning of the WARN Act, (ii) issued any written notification of a plant closing or mass layoff required by the WARN Act (nor has Q32 or any of its Subsidiaries has been under any requirement or obligation to issue any such notification), or (iii) incurred any Liability or obligation under the WARN Act that remains unsatisfied.

(n) Since January 1, 2020, there has never been, nor to the Knowledge of Q32 has there been any threat of, any strike, slowdown, work stoppage, lockout, job action, union, organizing activity, question concerning representation or any similar activity or dispute, affecting Q32 or its Subsidiaries. No event has occurred within the past six (6) months, and, to the Knowledge of Q32, no condition or circumstance exists, that would reasonably be expected to give rise to or provide a basis for the commencement of any such strike, slowdown, work stoppage, lockout, job action, union organizing activity, question concerning representation or any similar activity or dispute.

(o) There is no contract, agreement, plan or arrangement to which Q32 or any of its Subsidiaries is a party or by which it is bound to make any payment or compensate any Q32 Associate for Taxes incurred pursuant to the Code, including, but not limited to, Section 4999 or Section 409A of the Code.

 

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(p) Neither the execution and delivery of this Agreement, the shareholder approval of this Agreement, nor the consummation of the Contemplated Transactions (either alone or in conjunction with any other event, including without limitation, a termination of employment) will result in any (i) payment (including severance, forgiveness of indebtedness or otherwise) or benefit becoming due to Q32 Associate, (ii) increase in any benefits or the compensation payable under any Q32 Employee Plan, (iii) acceleration of the time of payment, funding or vesting of any such compensation or benefits or any loan forgiveness, (iv) restriction on the right of Q32 or any of its Subsidiaries or, after the consummation of Contemplated Transactions, the Surviving Corporation, to merge, amend, terminate or transfer any Q32 Employee Plan, or (v) “excess parachute payment” (within the meaning of Section 280G of the Code).

3.18 Environmental Matters. Since January 1, 2020, Q32 and each of its Subsidiaries has complied with all applicable Environmental Laws, which compliance includes the possession by Q32 of all permits and other Governmental Authorizations required under applicable Environmental Laws and compliance with the terms and conditions thereof, except for any failure to be in compliance that, individually or in the aggregate, would not result in a Q32 Material Adverse Effect. Neither Q32 nor any of its Subsidiaries has received since January 1, 2020, any written notice or other communication (in writing or otherwise), whether from a Governmental Authority, citizens group, employee or otherwise, that alleges that Q32 or any of its Subsidiaries is not in compliance with any Environmental law, and, to the Knowledge of Q32, there are no circumstances that may prevent or interfere with Q32’s or any of its Subsidiaries’ compliance with any Environmental Law in the future, except where such failure to comply would not reasonably be expected to have a Q32 Material Adverse Effect. To the Knowledge of Q32: (a) no current or prior owner of any property leased or controlled by Q32 or any of its Subsidiaries has received since January 1, 2020, any written notice or other communication relating to property owned or leased at any time by Q32 or any of its Subsidiaries, whether from a Governmental Authority, citizens group, employee or otherwise, that alleges that such current or prior owner or Q32 or any of its Subsidiaries is not in compliance with or violated any Environmental Law relating to such property and (b) neither Q32 nor any of its Subsidiaries has any material Liability under any Environmental Law.

3.19 Insurance. Q32 has made available to Homology accurate and complete copies of all material insurance policies and all material self-insurance programs and arrangements relating to the business, assets, liabilities and operations of Q32 and its Subsidiaries. Each of such insurance policies is in full force and effect and Q32 and its Subsidiaries are in compliance in all material respects with the terms thereof. Other than customary end of policy notifications from insurance carriers, since January 1, 2020, neither Q32 nor any of its Subsidiaries has received any notice or other communication regarding any actual or possible: (a) cancellation or invalidation of any insurance policy or (b) refusal or denial of any coverage, reservation of rights or rejection of any material claim under any insurance policy. Each of Q32 and its Subsidiaries has provided timely written notice to the appropriate insurance carrier(s) of each Legal Proceeding pending against Q32 or such Subsidiary for which Q32 or such Subsidiary has insurance coverage, and no such carrier has issued a denial of coverage or a reservation of rights with respect to any such Legal Proceeding, or informed Q32 of its intent to do so.

3.20 Transactions with Affiliates. Section 3.20 of the Q32 Disclosure Schedule describes any material transactions or relationships, since January 1, 2020, between, on one hand, Q32 and, on the other hand, any (a) executive officer or director of Q32 or any of such executive officer’s or director’s immediate family members, (b) owner of more than five percent of the voting power of the outstanding shares of Q32 Common Stock or (c) to the Knowledge of Q32, any “related person” (within the meaning of Item 404 of Regulation S-K under the Securities Act) of any such officer, director or owner (other than Q32) in the case of each of (a), (b) or (c) that is of the type that would be required to be disclosed under Item 404 of Regulation S-K under the Securities Act.

3.21 No Financial Advisors. Except as set forth on Section 3.20 of the Q32 Disclosure Schedule, no broker, finder or investment banker is entitled to any brokerage fee, finder’s fee, opinion fee, success fee, transaction fee or other fee or commission in connection with the Contemplated Transactions based upon arrangements made by or on behalf of Q32.

 

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3.22 Privacy and Data Security.

(a) Q32 and its Subsidiaries have complied with all applicable Privacy Laws and the applicable terms of any Q32 Contracts relating to privacy, security, collection or use of Personal Information of any individuals (including clinical trial participants, patients, patient family members, caregivers or advocates, physicians and other health care professionals, clinical trial investigators, researchers, pharmacists) that interact with Q32 or any of its Subsidiaries in connection with the operation of Q32’s and its Subsidiaries’ business, except for such noncompliance as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Q32 Material Adverse Effect. To the Knowledge of Q32, Q32 has implemented and maintains reasonable written policies and procedures, satisfying the requirements of applicable Privacy Laws and Q32 Contracts, concerning the privacy, security, collection and use of Personal Information (the “Q32 Privacy Policies”) and has complied with the same, except for such noncompliance as has not to the Knowledge of Q32 had, and would not reasonably be expected to have, individually or in the aggregate, a Q32 Material Adverse Effect. To the Knowledge of Q32, as of the date hereof, no claims have been asserted or threatened against Q32 by any Person alleging a violation of Privacy Laws, Q32 Privacy Policies and/or the applicable terms of any Q32 Contracts relating to privacy, security, collection or use of Personal Information of any individuals and Q32 has not received written notice of any of the same. To the Knowledge of Q32, there have been no data security incidents, personal data breaches or other adverse events or incidents related to Personal Information or Q32 data in the custody or control of Q32 or any service provider acting on behalf of Q32, in each case where such incident, breach or event would result in a notification obligation to any Person under applicable law or pursuant to the terms of any Q32 Contract.

(b) The information technology assets and equipment of Q32 and its Subsidiaries (collectively, “Q32 IT Systems”) are adequate for, and operate and perform in all material respects as required in connection with the operation of the business of Q32 and its Subsidiaries as currently conducted, and to the Knowledge of Q32, free and clear of all material bugs, errors, defects, Trojan horses, time bombs, malware and other corruptants. Q32 and its Subsidiaries have implemented and maintain commercially reasonable physical, technical and administrative safeguards to protect Personal Information processed by or on behalf of Q32 and its Subsidiaries, any other material confidential information and the integrity and security of Q32 IT Systems used in connection with their businesses, and during the past three years, there have been no breaches, violations, outages or unauthorized uses of or accesses to same, except for those that have been remedied without material cost or Liability or the duty to notify any other Person.

3.23 Concurrent Financing.

(a) Q32 has delivered to Homology true, correct and complete copies of all definitive agreements related to the Concurrent Financing, including the Subscription Agreement, pursuant to which the Purchasers (as defined in the Subscription Agreement) party thereto (collectively, the “Purchasers”) have agreed, subject to the terms and conditions set forth therein, to purchase the number of shares of Q32 Common Stock set forth therein in connection with the transactions contemplated by this Agreement. The Subscription Agreement has not been amended or modified prior to the date of this Agreement and as of the date hereof, no such amendment or modification is contemplated (other than amendments or modifications that are permitted by Section 5.27), and as of the date hereof, the respective obligations and commitments contained in the Subscription Agreement have not been withdrawn or rescinded in any respect.

(b) As of the date hereof, the Subscription Agreement is in full force and effect and is the legal, valid, binding and enforceable obligation of Q32, and, to the Knowledge of Q32, each of the Purchasers. There are no conditions precedent or other contingencies related to the funding of the full amount of the Concurrent Financing, other than as expressly set forth in the Subscription Agreement. As of the date hereof, no event has occurred which, with or without notice, lapse of time or both, would reasonably be expected to constitute a default or breach on the part of Q32 or, to the Knowledge of Q32, any Purchaser under the Subscription Agreement. As of the date hereof, Q32 has no reason to believe that any of the conditions to the Concurrent Financing as contemplated by the Subscription Agreement will not be satisfied.

 

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3.24 No Other Representations or Warranties. Q32 hereby acknowledges and agrees that, except for the representations and warranties contained in this Agreement, neither Homology nor any other person on behalf of Homology makes any express or implied representation or warranty with respect to Homology or with respect to any other information provided to Q32, any of its stockholders or any of their respective Affiliates in connection with the Contemplated Transactions, and (subject to the express representations and warranties of Homology set forth in Article IV (in each case as qualified and limited by the Homology Disclosure Schedule)) none of Q32, or any of its Representatives or stockholders, has relied on any such information (including the accuracy or completeness thereof).

ARTICLE IV

REPRESENTATIONS AND WARRANTIES OF HOMOLOGY AND MERGER SUB

Except (i) as set forth in the written disclosure schedule delivered by Homology to Q32 (the “Homology Disclosure Schedule”) or (ii) as disclosed in the Homology SEC Documents filed with the SEC on or before the day that is one (1) Business Day prior to the date hereof and publicly available on the SEC’s Electronic Data Gathering Analysis and Retrieval system (but (A) without giving effect to any amendment thereof filed with, or furnished to the SEC on or after the date hereof and (B) excluding any disclosures contained under the heading “Risk Factors” and any disclosure of risks included in any “forward-looking statements” disclaimer or in any other section to the extent they are forward-looking statements or cautionary, predictive or forward-looking in nature), it being understood that any matter disclosed in the Homology SEC Documents shall not be deemed disclosed for purposes of Section 4.1(a), 4.1(b) or 4.3, Homology and Merger Sub represent and warrant to Q32 as follows:

4.1 Due Organization; Subsidiaries.

(a) Each of Homology and its Subsidiaries (including Merger Sub) is a corporation or other legal entity duly incorporated or otherwise organized, validly existing and in good standing under the Laws of the jurisdiction of its incorporation or organization and has all necessary power and authority: (i) to conduct its business in the manner in which its business is currently being conducted, (ii) to own or lease and use its property and assets in the manner in which its property and assets are currently owned or leased and used and (iii) to perform its obligations under all Contracts by which it is bound. Since the date of its formation, Merger Sub has not engaged in any activities other than in connection with or as contemplated by this Agreement. All of Homology’s Subsidiaries are wholly owned by Homology.

(b) Each of Homology and its Subsidiaries is licensed and qualified to do business, and is in good standing (to the extent applicable in such jurisdiction), under the Laws of all jurisdictions where the nature of its business in the manner in which its business is currently being conducted requires such licensing or qualification other than in jurisdictions where the failure to be so qualified individually or in the aggregate would not be reasonably expected to have a Homology Material Adverse Effect.

(c) Except as set forth on Section 4.1(c) of the Homology Disclosure Schedule, Homology has no Subsidiaries other than Merger Sub and Homology does not directly or indirectly own any capital stock of, or any equity ownership or profit sharing interest of any nature in, or control directly or indirectly, any other Entity other than Merger Sub. Homology is not and has not otherwise been, directly or indirectly, a party to, member of or participant in any partnership, joint venture or similar business entity. Homology has not agreed and is not obligated to make, nor is Homology bound by any Contract under which it may become obligated to make, any future investment in or capital contribution to any other Entity. Homology has not, at any time, been a general partner of, and has not otherwise been liable for any of the debts or other obligations of, any general partnership, limited partnership or other Entity.

 

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4.2 Organizational Documents. Homology has delivered to Q32 accurate and complete copies of the Organizational Documents of Homology and Merger Sub. Neither Homology nor Merger Sub is in breach or violation of its Organizational Documents in any material respect.

4.3 Authority; Binding Nature of Agreement. Each of Homology and Merger Sub has all necessary corporate power and authority to enter into and to perform its obligations under this Agreement and to consummate the Contemplated Transactions. The Homology Board (at meetings duly called and held) has: (a) determined that the Contemplated Transactions are fair to, advisable and in the best interests of Homology and its stockholders, (b) approved and declared advisable this Agreement and the Contemplated Transactions, including the issuance of shares of Homology Common Stock to the stockholders of Q32 pursuant to the terms of this Agreement and (c) determined to recommend the Homology Board Recommendation to the stockholders of Homology, and (d) determined to approve and recommend the forms of the Charter Amendment Proposals to the stockholders of Homology as promptly as practicable after the forms thereof are mutually agreed to by Homology and Q32. The Merger Sub Board (by unanimous written consent) has: (x) determined that the Contemplated Transactions are fair to, advisable, and in the best interests of Merger Sub and its sole stockholder, (y) deemed advisable and approved this Agreement and the Contemplated Transactions and (z) determined to recommend, upon the terms and subject to the conditions set forth in this Agreement, that the stockholder of Merger Sub vote to adopt this Agreement and thereby approve the Contemplated Transactions. This Agreement has been duly executed and delivered by Homology and Merger Sub and, assuming the due authorization, execution and delivery by Q32, constitutes the legal, valid and binding obligation of Homology and Merger Sub, enforceable against each of Homology and Merger Sub in accordance with its terms, subject to the Enforceability Exceptions.

4.4 Vote Required. The affirmative vote of a majority of the votes cast at the Homology Stockholder Meeting is the only vote of the holders of any class or series of Homology Common Stock necessary to approve this Agreement and the Contemplated Transactions, including the issuance of the shares of Homology Common Stock to the stockholders of Q32 in the Merger pursuant to the terms of this Agreement (the “Required Homology Stockholder Vote”) .

4.5 Non-Contravention; Consents.

(a) Subject to obtaining the Required Homology Stockholder Vote and the filing of the Certificate of Merger required by Delaware Law, neither (x) the execution, delivery or performance of this Agreement by Homology or Merger Sub, nor (y) the consummation of the Contemplated Transactions, will directly or indirectly (with or without notice or lapse of time):

(i) contravene, conflict with or result in a violation of any of the provisions of the Organizational Documents of Homology or its Subsidiaries;

(ii) contravene, conflict with or result in a material violation of, or give any Governmental Authority or other Person the right to challenge the Contemplated Transactions or to exercise any remedy or obtain any relief under, any Law or any Order to which Homology or its Subsidiaries, or any of the assets owned or used by Homology or its Subsidiaries, is subject;

(iii) contravene, conflict with or result in a material violation of any of the terms or requirements of, or give any Governmental Authority the right to revoke, withdraw, suspend, cancel, terminate or modify, any Governmental Authorization that is held by Homology or its Subsidiaries or that otherwise relates to the business of Homology, or any of the assets owned, leased or used by Homology;

(iv) contravene, conflict with or result in a violation or breach of, or result in a default under, any provision of any Homology Material Contract, or give any Person the right to: (A) declare a default or exercise any remedy under any Homology Material Contract, (B) any material payment, rebate, chargeback, penalty or change in delivery schedule under any such Homology Material Contract, (C) accelerate the maturity or performance of any Homology Material Contract or (D) cancel, terminate or modify any term of

 

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any Homology Material Contract, except in the case of any nonmaterial breach, default, penalty or modification; or

(v) result in the imposition or creation of any Encumbrance upon or with respect to any asset owned or used by Homology or its Subsidiaries (except for Permitted Encumbrances).

(b) Except for (i) any Consent set forth on Section 4.5 of the Homology Disclosure Schedule under any Homology Contract, (ii) the Required Homology Stockholder Vote, (iii) the filing of the Certificate of Merger with the Secretary of State of the State of Delaware pursuant to Delaware Law and (iv) such consents, waivers, approvals, orders, authorizations, registrations, declarations and filings as may be required under applicable federal and state securities laws, neither Homology nor any of its Subsidiaries was, is or will be required to make any filing with or give any notice to, or to obtain any Consent from, any Person in connection with (x) the execution, delivery or performance of this Agreement or (y) the consummation of the Contemplated Transactions.

(c) The Homology Board and the Merger Sub Board have taken and will take all actions necessary to ensure that the restrictions applicable to business combinations contained in Section 203 of Delaware Law are, and will be, inapplicable to the execution, delivery and performance of this Agreement and to the consummation of the Contemplated Transactions. No other state takeover statute or similar Law applies or purports to apply to the Merger, this Agreement or any of the other Contemplated Transactions.

4.6 Capitalization.

(a) The authorized capital stock of Homology consists of (i) 200,000,000 shares of common stock, par value $0.0001 per share (“Homology Common Stock”), of which 57,934,332 shares have been issued and are outstanding as of November 10, 2023 and (ii) 10,000,000 shares of preferred stock, par value $0.0001 per share (“Homology Preferred Stock”), of which no shares have been issued and are outstanding as of November 10, 2023 (the “Capitalization Date”). Homology does not hold any shares of its capital stock in its treasury.

(b) All of the outstanding shares of Homology Common Stock have been duly authorized and validly issued, and are fully paid and nonassessable and are free of any Encumbrances other than under applicable securities Laws. None of the outstanding shares of Homology Common Stock is entitled or subject to any preemptive right, right of participation, right of maintenance or any similar right and none of the outstanding shares of Homology Common Stock is subject to any right of first refusal in favor of Homology. Except as contemplated herein, there is no Homology Contract relating to the voting or registration of, or restricting any Person from purchasing, selling, pledging or otherwise disposing of (or granting any option or similar right with respect to), any shares of Homology Common Stock. Homology is not under any obligation, nor is it bound by any Contract pursuant to which it may become obligated, to repurchase, redeem or otherwise acquire any outstanding shares of Homology Common Stock or other securities. Section 4.6(b) of the Homology Disclosure Schedule accurately and completely lists all repurchase rights held by Homology with respect to shares of Homology Common Stock (including shares issued pursuant to the exercise of options) and specifies which of those repurchase rights are currently exercisable.

(c) Except for the Homology Equity Plans and the Homology Options and Homology Restricted Stock Unit Awards granted thereunder, Homology does not have any stock incentive plan or any other plan, program, agreement or arrangement providing for any equity or equity-based compensation for any Person and there were no other equity or equity-based awards outstanding as of the date of this Agreement. As of the Capitalization Date, Homology has reserved 13,363,775 shares of Homology Common Stock for issuance under the Homology Equity Plans, of which 416,819 shares have been issued and are outstanding pursuant to the exercise of Homology Options or settlement of Homology Restricted Stock Units, 10,225,976 shares are subject to outstanding Homology Options, 460,388 shares are subject to outstanding Homology Restricted Stock Unit Awards, and 1,978,793 shares remain available for future grant pursuant to the Homology Equity Plans.

 

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Section 4.6(c) of the Homology Disclosure Schedule sets forth a true and complete list, as of November 1, 2023, of each outstanding Homology Option and Homology Restricted Stock Unit award, including: (i) the name of the holder, (ii) the number of shares of Homology Common Stock subject to such Homology Option and/or Homology Restricted Stock Unit Award, (iii) the exercise price of each Homology Option, (iv) the date of grant, (v) the applicable vesting schedule, including any acceleration provisions and the number of vested and unvested shares, (vi) the expiration date, as applicable, and (vii) whether the Homology Option is intended to be an “incentive stock option” (as defined in the Code) or a non-qualified stock option. Homology has made available to Q32 accurate and complete copies of the following (except for such documents that are filed as an exhibit to a Homology SEC Document): (A) the standard form of agreement evidencing Homology Options and Homology Restricted Stock Unit Awards; and (B) each agreement evidencing a Homology Option or Homology Restricted Stock Unit Award that does not conform in all material respects to the standard form agreement.

(d) Except as set forth on Section 4.6(c) of the Homology Disclosure Schedule, there is no: (i) outstanding subscription, option, call, warrant or right (whether or not currently exercisable) to acquire any shares of the capital stock or other securities of Homology, (ii) outstanding security, instrument or obligation that is or may become convertible into or exchangeable for any shares of the capital stock or other securities of Homology, (iii) stockholder rights plan (or similar plan commonly referred to as a “poison pill”) or Contract under which Homology is or may become obligated to sell or otherwise issue any shares of its capital stock or any other securities or (iv) condition or circumstance that may give rise to or provide a basis for the assertion of a claim by any Person to the effect that such Person is entitled to acquire or receive any shares of capital stock or other securities of Homology.

(e) All outstanding shares of Homology Common Stock and other securities of Homology have been issued and granted in material compliance with (i) all applicable securities laws and other applicable Law and (ii) all requirements set forth in applicable Contracts.

4.7 SEC Filings; Financial Statements.

(a) Homology has filed or furnished, as applicable, on a timely basis all forms, statements, certifications, reports and documents required to be filed or furnished by it with the SEC under the Exchange Act or the Securities Act since January 1, 2021 (the “Homology SEC Documents”). As of the time it was filed with the SEC (or, if amended or superseded by a filing prior to the date of this Agreement, then on the date of such filing), each of the Homology SEC Documents complied in all material respects with the applicable requirements of the Securities Act or the Exchange Act (as the case may be) and as of the time they were filed, none of the Homology SEC Documents contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. The certifications and statements required by (i) Rule 13a-14 under the Exchange Act and (ii) 18 U.S.C. §1350 (Section 906 of the Sarbanes-Oxley Act) relating to the Homology SEC Documents (collectively, the “Homology Certifications”) are accurate and complete and comply as to form and content with all applicable Laws. As used in this Section 4.7, the term “file” and variations thereof shall be broadly construed to include any manner in which a document or information is furnished, supplied or otherwise made available to the SEC.

(b) The financial statements (including any related notes) contained or incorporated by reference in the Homology SEC Documents: (i) complied as to form in all material respects with the Securities Act and the Exchange Act, as applicable, and the published rules and regulations of the SEC applicable thereto, (ii) were prepared in accordance with GAAP (except as may be indicated in the notes to such financial statements or, in the case of unaudited financial statements, as permitted by Form 10-Q of the SEC, and except that the unaudited financial statements are subject to normal and recurring year-end adjustments that are not reasonably expected to be material in amount) applied on a consistent basis unless otherwise noted therein throughout the periods indicated and (iii) fairly present, in all material respects, the financial position of Homology as of the respective dates thereof and the results of operations and cash flows of Homology for the periods covered thereby. Other

 

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than as expressly disclosed in the Homology SEC Documents filed prior to the date hereof, there has been no material change in Homology’s accounting methods or principles that would be required to be disclosed in Homology’s financial statements in accordance with GAAP. The books of account and other financial records of Homology and each of its Subsidiaries are true and complete in all material respects.

(c) Homology’s auditor has at all times since the date of enactment of the Sarbanes-Oxley Act been: (i) a registered public accounting firm (as defined in Section 2(a)(12) of the Sarbanes-Oxley Act), (ii) to the Knowledge of Homology, “independent” with respect to Homology within the meaning of Regulation S-X under the Exchange Act and (iii) to the Knowledge of Homology, in compliance with subsections (g) through (l) of Section 10A of the Exchange Act and the rules and regulations promulgated by the SEC and the Public Company Accounting Oversight Board thereunder.

(d) Except as set forth on Section 4.7(d) of the Homology Disclosure Schedule, Homology has not received any comment letter from the SEC or the staff thereof or any correspondence from Nasdaq or the staff thereof relating to the delisting or maintenance of listing of Homology Common Stock on Nasdaq. Homology has not disclosed any unresolved comments in the Homology SEC Documents.

(e) There have been no formal internal investigations regarding financial reporting or accounting policies and practices discussed with, reviewed by or initiated at the direction of the chief executive officer, chief financial officer, or general counsel of Homology, the Homology Board or any committee thereof, other than ordinary course audits or reviews of accounting policies and practices or internal controls required by the Sarbanes-Oxley Act.

(f) Except as set forth on Section 4.7(f) of the Homology Disclosure Schedule, Homology is in compliance in all material respects with the applicable provisions of the Sarbanes-Oxley Act, the Exchange Act and the applicable listing and governance rules and regulations of Nasdaq.

(g) Homology maintains a system of internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-l5(f) of the Exchange Act) that is sufficient to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP, including policies and procedures sufficient to provide reasonable assurance (i) that Homology maintains records that in reasonable detail accurately and fairly reflect Homology’s transactions and dispositions of assets, (ii) that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, (iii) that receipts and expenditures are made only in accordance with authorizations of management and the Homology Board and (iv) regarding prevention or timely detection of the unauthorized acquisition, use or disposition of Homology’s assets that could have a material effect on Homology’s financial statements. Homology has evaluated the effectiveness of Homology’s internal control over financial reporting and, to the extent required by applicable Law, presented in any applicable Homology SEC Document that is a report on Form 10-K or Form 10-Q (or any amendment thereto) its conclusions about the effectiveness of the internal control over financial reporting as of the end of the period covered by such report or amendment based on such evaluation. Homology has disclosed to Homology’s auditors and the Audit Committee of the Homology Board (and made available to Homology a summary of the significant aspects of such disclosure) (A) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting that are reasonably likely to adversely affect Homology’s ability to record, process, summarize and report financial information and (B) any known fraud, whether or not material, that involves management or other employees who have a significant role in Homology or its Subsidiaries’ internal control over financial reporting. Except as disclosed in the Homology SEC Documents filed prior to the date hereof, Homology’s internal control over financial reporting is effective and Homology has not identified any material weaknesses in the design or operation of Homology’s internal control over financial reporting.

(h) Homology’s “disclosure controls and procedures” (as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act) are designed to ensure that all information (both financial and nonfinancial) required to be

 

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disclosed by Homology in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC, and that all such information is accumulated and communicated to Homology’s principal executive officer and principal financial officer as appropriate to allow timely decisions regarding required disclosure and to make the Homology Certifications and such disclosure controls and procedures are effective. Homology has carried out evaluation of the effectiveness of its disclosure controls and procedures as required by Rule 13a-l5 of the Exchange Act.

(i) Homology has not been and is not currently a “shell company” as defined under Section 12b-2 of the Exchange Act.

4.8 Absence of Changes. Except as set forth on Section 4.8 of the Homology Disclosure Schedule, since January 1, 2023, Homology and its Subsidiaries have conducted its business only in the Ordinary Course of Business (except for the execution and performance of this Agreement and the discussions, negotiations and transactions related thereto) and there has not been any (a) Homology Material Adverse Effect or (b) action, event or occurrence that would have required consent of Homology pursuant to Section 5.2 of this Agreement had such action, event or occurrence taken place after the execution and delivery of this Agreement.

4.9 Absence of Undisclosed Liabilities. Neither Homology nor any of its Subsidiaries has any Liability of a type required to be reflected or reserved for on a balance sheet prepared in accordance with GAAP, except for: (a) Liabilities disclosed, reflected or reserved against in the Homology Balance Sheet, (b) normal and recurring current Liabilities that have been incurred by Homology or its Subsidiaries since the date of the Homology Balance Sheet in the Ordinary Course of Business (none of which relates to any breach of contract, breach of warranty, tort, infringement, or violation of Law), (c) Liabilities for performance of obligations of Homology or any of its Subsidiaries under Homology Contracts, (d) Liabilities incurred in connection with the Contemplated Transactions and the Subscription Agreement and (e) Liabilities listed in Section 4.9 of the Homology Disclosure Schedule.

4.10 Title to Assets. Each of Homology and its Subsidiaries owns, and has good and valid title to, or, in the case of leased properties and assets, valid leasehold interests in, all tangible properties or tangible assets and equipment used or held for use in its business or operations or purported to be owned by it, including: (a) all tangible assets reflected on the Homology Balance Sheet and (b) all other tangible assets reflected in the books and records of Homology as being owned by Homology. All of such assets are owned or, in the case of leased assets, leased by Homology or any of its Subsidiaries free and clear of any Encumbrances, other than Permitted Encumbrances.

4.11 Real Property; Leasehold. Neither Homology nor any of its Subsidiaries owns or has ever owned any real property. Homology has made available to Q32 (a) an accurate and complete list of all real properties with respect to which Homology directly or indirectly holds a valid leasehold interest as well as any other real estate that is in the possession of or leased by Homology or any of its Subsidiaries and (b) copies of all leases under which any such real property is possessed (the “Homology Real Estate Leases”), each of which is in full force and effect, with no existing material default thereunder.

4.12 Intellectual Property.

(a) Section 4.12(a) of the Homology Disclosure Schedule is an accurate, true and complete listing of all Homology Registered IP, including for each item (i) the record owner (and name of any other Person with an ownership interest in such item of Homology Registered IP, if any), jurisdiction (or, with respect to domain names, the applicable registrar), status, date and registration or application number of each item, as applicable, (ii) the name of the record owner and any other Person that has an ownership interest in such item of Homology Registered IP, and the nature of such ownership interest, and (iii) any actions that are required to be taken within 180 days of the date hereof for any Homology Registered IP, including the payment of any registration, maintenance or renewal fees or the filing of or response to any documents, applications or certificates, for the

 

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purposes of prosecuting, obtaining, perfecting, maintaining or renewing any Homology Registered IP. Section 4.12(a) of the Homology Disclosure Schedule also sets forth, as of the date of this Agreement, a list of all internet domain names with respect to which Homology or any of its Subsidiaries are the registrant and, with respect to each domain name, the record owner of such domain name and if different, the legal and beneficial owner(s) of such domain name and the applicable domain name registrar.

(b) Section 4.12(b) of the Homology Disclosure Schedule accurately identifies (all Homology Contracts pursuant to which any material Homology IP Rights are licensed to Homology (other than (A) any non-customized software that (1) is so licensed solely in executable or object code form pursuant to a nonexclusive, internal use software license and other Intellectual Property associated with such software and (2) is not incorporated into, or material to the development, manufacturing, or distribution of, any of Homology’s or its Subsidiaries’ products or services, (B) any Intellectual Property licensed on a nonexclusive basis ancillary to the purchase or use of equipment, reagents or other materials, (C) any confidential information provided under confidentiality agreements and (D) agreements between Homology or its Subsidiaries and their respective employees in Homology’s standard form thereof). To the Knowledge of Homology, each Homology Contract listed in Section 4.12(b) of the Homology Disclosure Schedule is in full force and effect and constitutes a legal, valid, and binding obligation of Homology, its Subsidiaries and each other party thereto, and is enforceable against Homology, its Subsidiaries and each other party thereto in accordance with its terms. To the Knowledge of Homology, neither Homology, its Subsidiaries, nor any other party to any Homology Contract listed in Section 4.12(b) of the Homology Disclosure Schedule has been or is, or has been or is alleged to be, in material default under, or has provided or received any notice of breach under, or intention to terminate (including by non-renewal), any Homology Contract listed in Section 4.12(b) of the Homology Disclosure Schedule, except as would not reasonably be expected to have, individually or in the aggregate, a Homology Material Adverse Effect.

(c) Except for instances that would not reasonably be expected to have, individually or in the aggregate, a Homology Material Adverse Effect, Section 4.12(c) of the Homology Disclosure Schedule accurately identifies each Homology Contract pursuant to which any Person has been granted any license under, or otherwise has received or acquired any right (whether or not currently exercisable) or interest in, any Homology IP Rights (other than (i) any confidential information provided under confidentiality agreements and (ii) any Homology IP Rights nonexclusively licensed to academic collaborators, suppliers or service providers for the sole purpose of enabling such academic collaborator, supplier or service providers to provide services for Homology’s or its Subsidiaries’ benefit). To the Knowledge of Homology, each Homology Contract listed in Section 4.12(c) of the Homology Disclosure Schedule is in full force and effect and constitutes a legal, valid, and binding obligation of Homology, its Subsidiaries and each other party thereto, and is enforceable against Homology, its Subsidiaries and each other party thereto in accordance with its terms. Neither Homology, its Subsidiaries nor, to the Knowledge of Homology, any other party to any Homology Contract listed in Section 4.12(c) of the Homology Disclosure Schedule has provided or received any written notice or allegation of breach under, or intention to terminate (including by non-renewal), any Homology Contract listed in Section 4.12(c) of the Homology Disclosure Schedule.

(d) Except as identified on Section 4.12(d) of the Homology Disclosure Schedule, neither Homology nor any of its Subsidiaries is bound by, no Homology Owned IP Rights are subject to, and to the Knowledge of Homology, no Homology Licensed IP Rights are subject to, any Contract containing any covenant or other provision that in any way limits or restricts the ability of Homology or any of its Subsidiaries to use, exploit, assert, or enforce any Homology IP Rights anywhere in the world, except as would not reasonably be expected to have, individually or in the aggregate, a Homology Material Adverse Effect.

(e) Homology or one of its Subsidiaries exclusively owns all right, title, and interest to and in the Homology IP Rights (other than (i) Homology Licensed IP Rights, or co-owned rights each as identified in Section 4.12(c) of the Homology Disclosure Schedule, (ii) any non-customized software that (A) is licensed to Homology or its Subsidiaries solely in executable or object code form pursuant to a nonexclusive, internal use software license and other Intellectual Property associated with such software and (B) is not incorporated into, or material to the

 

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development, manufacturing, or distribution of, any of Homology or its Subsidiaries’ products or services and (iii) any Intellectual Property licensed on a nonexclusive basis ancillary to the purchase or use of equipment, reagents or other materials), in each case, free and clear of any Encumbrances (other than Permitted Encumbrances).

(f) To the Knowledge of Homology, (i) all documents and instruments necessary to register or apply for or renew registration of Homology Registered IP owned by Homology, and (ii) all documents and instruments necessary to register or apply for or renew registration of Homology Registered IP exclusively licensed to Homology, have been validly executed, delivered, and filed in a timely manner with the appropriate Governmental Authority. To the Knowledge of Homology, (A) Homology has filed all statements of use and paid all renewal and maintenance fees, annuities and other fees with respect to the Homology Registered IP owned by Homology, and (B) Homology has executed all documents and instruments necessary to register or apply for or renew registration of Homology Registered IP exclusively licensed to Homology, in each case (A) and (B), that are due or payable as of the date of this Agreement.

(g) Except for instances that would not reasonably be expected to have, individually or in the aggregate, a Homology Material Adverse Effect, to the Knowledge of Homology each Person who is or was an employee, contractor or consultant of Homology or any of its Subsidiaries and who is or was involved in the creation, discovery, reduction to practice or development of any Intellectual Property for Homology or any of its Subsidiaries has signed a valid, enforceable written agreement containing a present assignment of all right, title and interest in and to such Intellectual Property to Homology or such Subsidiary and confidentiality provisions protecting trade secrets and confidential information of Homology and its Subsidiaries.

(h) To the Knowledge of Homology, no current or former member, officer, director, or employee of Homology or any of its Subsidiaries has any claim, right (whether or not currently exercisable), or interest to or in any Homology IP Rights purported to be owned by Homology. To the Knowledge of Homology, no employee of Homology or any of its Subsidiaries is (A) bound by or otherwise subject to any Contract restricting him or her from performing his or her duties for Homology or such Subsidiary or (B) in breach of any Contract with any former employer or other Person concerning Homology IP Rights purported to be owned by Homology or such Subsidiary or confidentiality provisions protecting trade secrets and confidential information comprising Homology IP Rights purported to be owned by Homology or such Subsidiary.

(i) No funding, facilities, or personnel of any Governmental Authority were used, directly or indirectly, to develop or create, in whole or in part, any Homology Owned IP Rights, or, to the Knowledge of Homology, any Homology Licensed IP Rights, and no educational institution has any right to, or right to royalties for, or to impose any requirement on the manufacture or commercialization of any product incorporating, any Homology Owned IP Rights, or, to the Knowledge of Homology, any Homology Licensed IP Rights. To the Knowledge of Homology, no Governmental Authority has any right to (including any “step-in” or “march-in” rights with respect to), ownership of, commercialization of, or right to royalties or other payments for any Homology Owned IP Rights, or, to the Knowledge of Homology, any Licensed IP Rights. Without limiting the generality of the foregoing, to the Knowledge of Homology, no invention claimed or covered by any Patent within the Homology Owned IP Rights, or, to the Knowledge of Homology, any Homology Licensed IP Rights, (A) was conceived or reduced to practice in connection with any research activities funded, in whole or in part, by the federal government of the United States or any agency thereof, (B) is a “subject invention” as that term is described in 35 U.S.C. Section 201(e), or (C) is otherwise subject to the provisions of the Bayh-Dole Act or any similar Law of any other jurisdiction, including with respect to any Patents that are part of the Homology IP Rights.

(j) Homology and each of its Subsidiaries has taken reasonable steps to maintain the confidentiality of and otherwise protect, maintain and enforce its rights in all proprietary information that Homology or such Subsidiary holds, or purports to hold, as confidential or a trade secret. To the Knowledge of Homology, neither Homology nor any of its Subsidiaries has made any of its trade secrets or other material confidential or proprietary information that it intended to maintain as confidential information available to any other Person except pursuant

 

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to written agreements requiring such Person to maintain the confidentiality of such trade secrets or confidential information. To the Knowledge of Homology, there have been no material security breaches, outages, violations or unauthorized access to any of the proprietary information that Homology or any of its Subsidiaries holds, or purports to hold, as confidential or a trade secret, except as would not reasonably be expected to have, individually or in the aggregate, a Homology Material Adverse Effect.

(k) Neither Homology nor any of its Subsidiaries has assigned or otherwise transferred ownership of, or agreed to assign or otherwise transfer ownership of, any Homology IP Rights, to any other Person.

(l) To the Knowledge of Homology, neither Homology nor any of its Subsidiaries has taken or failed to take any action that could be reasonably expected to result in the abandonment, invalidity, cancellation, forfeiture, relinquishing, invalidation or unenforceability of any Homology IP Rights (including with respect to any trademark, a failure to exercise adequate quality controls or an assignment in gross without the accompanying goodwill). To the Knowledge of Homology, each item of Homology IP Right has been duly maintained and is not expired, abandoned or cancelled. To the Knowledge of Homology, each of the Patents included in the Homology IP Rights identifies each and every inventor of the claims thereof as determined in accordance with the applicable laws of the jurisdiction in which such Patent is issued or pending. To the Knowledge of Homology, neither Homology nor any of its Subsidiaries has engaged in patent or copyright misuse or any fraud or inequitable conduct in connection with any Homology IP Right. To the Knowledge of Homology, each of Homology and its Subsidiaries and their respective patent counsel have complied with its duty of candor and disclosure and have made no material misrepresentations in the filings submitted to the applicable Governmental Authorities with respect to all Patents included in the Homology IP Rights for which Homology or any of its Subsidiaries is responsible for prosecuting.

(m) To the Knowledge of Homology, the Homology IP Rights constitute all Intellectual Property necessary for Homology to conduct its business as currently conducted or proposed to be conducted; provided, however, that the foregoing representation is not a representation with respect to non-infringement of Intellectual Property.

(n) Homology has delivered, or made available to Q32, a complete and accurate copy of all material Homology IP Rights Agreements.

(o) To the Knowledge of Homology, the manufacture, marketing, offering for sale, sale, importation, use or intended use or other disposal of any product as currently sold or under development by Homology does not violate any license or agreement between Homology or its Subsidiaries and any third party in any material respect, and, to the Knowledge of Homology, does not infringe or misappropriate any valid and issued Patent or other Intellectual Property of any other Person, which infringement or misappropriation would reasonably be expected to have a Homology Material Adverse Effect. To the Knowledge of Homology, no third party is infringing upon any Patents owned by Homology within the Homology IP Rights, or otherwise violating any Homology IP Rights Agreement.

(p) As of the date of this Agreement, neither Homology nor any of its Subsidiaries is a party to any Legal Proceeding (including, but not limited to, opposition, interference or other proceeding in any patent or other government office) contesting the validity, ownership or right to use, sell, offer for sale, license or dispose of any Homology IP Rights. None of the Homology IP Rights, and to the Knowledge of Homology, none of the Homology Licensed IP Rights, have been adjudged invalid or unenforceable in whole or part, and all Homology Owned IP Rights, and to the Knowledge of Homology, all Homology Licensed IP Rights, are in full force and effect. No Patent within the Homology Registered IP owned by Homology, or to the Knowledge of Homology, no Patents within the Homology Registered IP exclusively licensed to Homology, have been subject to any interference, derivation, reexamination (including ex parte reexamination, inter partes reexamination, inter partes review, or post grant review), reissue, cancellation, opposition, claim, allegation or other action, including any proceeding in which the scope, validity, inventorship, ownership or enforceability of any such Patent is being, has been, or could reasonably be expected to be, contested or challenged. Neither Homology nor any of its

 

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Subsidiaries have received any written notice asserting that any Homology IP Rights or the proposed use, sale, offer for sale, license or disposition of products, methods, or processes claimed or covered thereunder infringes or misappropriates or violates the rights of any other Person or that Homology or any of its Subsidiaries have otherwise infringed, misappropriated or otherwise violated any Intellectual Property of any Person.

(q) To the Knowledge of Homology, no trademark (whether registered or unregistered) or trade name owned, used, or applied for by Homology conflicts or interferes with any trademark (whether registered or unregistered) or trade name owned, used, or applied for by any other Person except as would not have a Homology Material Adverse Effect. To the Knowledge of Homology, none of the goodwill associated with or inherent in any trademark (whether registered or unregistered) in which Homology or its Subsidiaries has or purports to have an ownership interest has been impaired as determined by Homology in accordance with GAAP. Section 4.12(q) of the Homology Disclosure Schedule sets forth all material unregistered trademarks included in the Homology IP Rights.

(r) Except (i) as would reasonably be expected to have a Homology Material Adverse Effect, (ii) as may be set forth in Section 4.12(b) or 4.12(c) of the Homology Disclosure Schedule or (iii) as contained in license, distribution or service agreements entered into in the Ordinary Course of Business by Homology, to the Knowledge of Homology, (A) neither Homology nor any of its Subsidiaries is bound by any Contract to indemnify, defend, hold harmless, or reimburse any other Person with respect to any Intellectual Property infringement, misappropriation, or similar claim which is material to Homology or any of its Subsidiaries, taken as a whole and (B) neither Homology nor any of its Subsidiaries has ever assumed, or agreed to discharge or otherwise take responsibility for, any existing or potential liability of another Person for infringement, misappropriation, or violation of any Intellectual Property right, which assumption, agreement or responsibility remains in force as of the date of this Agreement.

(s) To the Knowledge of Homology, neither Homology nor any of its Subsidiaries is party to any Contract that, as a result of such execution, delivery and performance of this Agreement, will (i) cause the grant, assignment or transfer to any other third party of any license or other right to or in any Homology IP Rights, (ii) result in breach of, default under termination of, or acceleration or modification of such Contract with respect to any Homology IP Rights, (iii) alter, encumber impair or extinguish, or result in any Encumbrance with respect to the right of Homology or the Surviving Corporation and its Subsidiaries to use, sell or license or enforce any Homology IP Rights or portion thereof or (iv) result in Homology or any of its Subsidiaries being bound by or subject to any exclusivity obligations, non-compete or other restrictions on the operation or scope of their respective businesses, or to any obligation to grant any rights in or to any Homology IP Rights, except, in each of (i), (ii), (iii) and (iv), for the occurrence of any such grant or impairment that would not individually or in the aggregate, reasonably be expected to result in a Homology Material Adverse Effect.

4.13 Agreements, Contracts and Commitments.

(a) Section 4.13 of the Homology Disclosure Schedule lists the following Homology Contracts in effect as of the date of this Agreement other than the Subscription Agreement (each, a “Homology Material Contract” and collectively, the “Homology Material Contracts”):

(i) each Homology Contract that is a collective bargaining agreement or other agreement or arrangement with any labor union, works council or labor organization;

(ii) each Homology Contract for the employment or engagement of any individual on an employee, consulting or other basis that provides for annual base compensation in excess of $200,000;

(iii) each Homology Contract with any Homology Associate that provides for retention, change in control, transaction or other similar payments or benefits, whether or not payable as a result of the Contemplated Transactions;

(iv) each Homology Contract relating to any agreement of indemnification or guaranty not entered into in the Ordinary Course of Business;

 

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(v) each Homology Contract containing (A) any covenant limiting the freedom of Homology or any of its Subsidiaries to engage in any line of business or compete with any Person, or limiting the development, manufacture, or distribution of Homology’s products or services, (B) any most-favored pricing arrangement, (C) any exclusivity provision or (D) any non-solicitation provision;

(vi) each Homology Contract (A) pursuant to which any Person granted Homology an exclusive license under any Intellectual Property, or (B) pursuant to which Homology granted any Person an exclusive license under any Homology IP Rights;

(vii) each Homology Contract relating to capital expenditures and requiring payments after the date of this Agreement in excess of $500,000 pursuant to its express terms and not cancelable without penalty;

(viii) each Homology Contract relating to the disposition or acquisition of material assets or any ownership interest in any Entity, in each case, involving payments in excess of $250,000 after the date of this Agreement;

(ix) each Homology Contract relating to any mortgages, indentures, loans, notes or credit agreements, security agreements or other agreements or instruments relating to the borrowing of money or extension of credit in excess of $500,000 or creating any material Encumbrances with respect to any assets of Homology or any loans or debt obligations with officers or directors of Homology;

(x) each Homology Contract requiring payment by or to Homology after the date of this Agreement in excess of $500,000 pursuant to its express terms relating to: (A) any distribution agreement (identifying any that contain exclusivity provisions), (B) any agreement involving provision of services or products with respect to any pre-clinical or clinical development activities of Homology, (C) any dealer, distributor, joint marketing, alliance, joint venture, cooperation, development or other agreement currently in force under which Homology or any of its Subsidiaries has continuing obligations to develop or market any product, technology or service, or any agreement pursuant to which Homology or any of its Subsidiaries has continuing obligations to develop any Intellectual Property that will not be owned, in whole or in part, by Homology or such Subsidiary or (D) any Contract to license any Patent, trademark registration, service mark registration, trade name or copyright registration to or from any third party to manufacture or produce any product, service or technology of Homology or any of its Subsidiaries or any Contract to sell, distribute or commercialize any products or service of Homology or any of its Subsidiaries, in each case, except for Homology Contracts entered into in the Ordinary Course of Business;

(xi) each Homology Contract with any Person, including any financial advisor, broker, finder, investment banker or other Person, providing advisory services to Homology in connection with the Contemplated Transactions;

(xii) each Homology Contract to which Homology or any of its Subsidiaries is a party or by which any of their assets and properties is currently bound, which involves annual obligations of payment by, or annual payments to, Homology or such Subsidiary in excess of $500,000;

(xiii) a Homology Real Estate Lease;

(xiv) a Contract disclosed in or required to be disclosed in Section 4.12(b) or Section 4.12(c) of the Homology Disclosure Schedule; or

(xv) any other Homology Contract that is not terminable at will (with no penalty or payment) by Homology or any of its Subsidiaries, and (A) which involves payment or receipt by Homology or such Subsidiary after the date of this Agreement under any such agreement, contract or commitment of more than $500,000 in the aggregate, or obligations after the date of this Agreement in excess of $1,000,000 in the aggregate or (B) that is material to the business or operations of Homology and its Subsidiaries taken as a whole.

(b) Homology has delivered or made available to Q32 accurate and complete copies of all Homology Material Contracts, including all amendments thereto. There are no Homology Material Contracts that are not in

 

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written form. Homology has not, nor, to Homology’s Knowledge as of the date of this Agreement, has any other party to a Homology Material Contract, breached, violated or defaulted under, or received notice that it breached, violated or defaulted under, any of the terms or conditions of any Homology Material Contract in such manner as would permit any other party to cancel or terminate any such Homology Material Contract, or would permit any other party to seek damages which would reasonably be expected to have a Homology Material Adverse Effect. As to Homology and its Subsidiaries, as of the date of this Agreement, each Homology Material Contract is valid, binding, enforceable and in full force and effect, subject to the Enforceability Exceptions. No Person is renegotiating, or has a right pursuant to the terms of any Homology Material Contract to change, any material amount paid or payable to Homology under any Homology Material Contract or any other material term or provision of any Homology Material Contract.

4.14 Compliance; Permits; Restrictions.

(a) Homology and each of its Subsidiaries is, and since January 1, 2020, has been in material compliance with all applicable Laws. No investigation, claim, suit, proceeding, audit, Order, or other action by any Governmental Authority is pending or, to the Knowledge of Homology, threatened against Homology or any of its Subsidiaries. There is no agreement or Order binding upon Homology or any of its Subsidiaries which (i) has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Homology or any of its Subsidiaries, any acquisition of material property by Homology or any of its Subsidiaries or the conduct of business by Homology or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Homology’s ability to comply with or perform any covenant or obligation under this Agreement or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.

(b) Each of Homology and its Subsidiaries holds all required Governmental Authorizations that are material to the operation of the business of Homology and Merger Sub as currently conducted (collectively, the “Homology Permits”). Section 4.14(b) of the Homology Disclosure Schedule identifies each Homology Permit. Each of Homology and its Subsidiaries is in material compliance with the terms of the Homology Permits. No Legal Proceeding is pending or, to the Knowledge of Homology, threatened, which seeks to revoke, substantially limit, suspend, or materially modify any Homology Permit.

(c) There are no Legal Proceedings pending or, to the Knowledge of Homology, threatened in writing with respect to an alleged material violation by Homology or any of its Subsidiaries of the FDCA, PHSA, FDA regulations adopted thereunder, the Controlled Substances Act or any other Law promulgated by a Drug Regulatory Agency.

(d) Each of Homology and its Subsidiaries holds all required material Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Homology and Merger Sub as currently conducted, and, as applicable, the research, development, testing, manufacturing, packaging, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its product candidates (the “Homology Product Candidates”) (collectively, the “Homology Regulatory Permits”) and no such Homology Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any material, adverse manner. Homology has timely maintained and is in compliance in all material respects with the Homology Regulatory Permits and neither Homology nor any of its Subsidiaries has, since January 1, 2020, received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Homology Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Homology Regulatory Permit.

(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Homology or its Subsidiaries, in which Homology or its Subsidiaries or their respective product candidates, including the Homology Product Candidates, have participated, were and, if still pending, are being conducted in

 

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compliance in all material respects with the applicable regulations of the Drug Regulatory Agencies and other applicable Law, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Other than as set forth on Section 4.14(e) of the Homology Disclosure Schedule, neither Homology nor any of its Subsidiaries has received any written notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to the Knowledge of Homology, any action to place a clinical hold order on, or otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, Homology or any of its Subsidiaries or in which Homology or any of its Subsidiaries or its current product candidates, including the Homology Product Candidates, have participated.

(f) Neither Homology nor any of its Subsidiaries has, and, to the Knowledge of Homology, any contract manufacturer with respect to any Homology Product Candidate, is the subject of any pending or, to the Knowledge of Homology, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto, or any other applicable Law. To the Knowledge of Homology, neither Homology nor any of its Subsidiaries nor any contract manufacturer with respect to any Homology Product Candidate has committed any acts, made any statement, or failed to make any statement, in each case in respect of Homology’s business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto, or any other applicable Law. None of Homology, any of its Subsidiaries, and to the Knowledge of Homology, any contract manufacturer with respect to any Homology Product Candidate, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion under (i) 21 U.S.C. Section 335a (ii) 42 U.S.C. § 1320a-7, or (iii) any other applicable Law. To the Knowledge of Homology, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Homology, any of its Subsidiaries, and to the Knowledge of the Homology, any contract manufacturer with respect to any Homology Product Candidate, or any of its officers, employees or agents. Neither Homology nor any of its Subsidiaries is a party to or has any reporting obligations under any corporate integrity agreements, monitoring agreements, deferred or non-prosecution agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Authority.

(g) All manufacturing operations conducted by, or to the Knowledge of Homology, for the benefit of, Homology or its Subsidiaries in connection with any Homology Product Candidate, since January 1, 2020, have been and are being conducted in compliance in all material respects with applicable Laws, including the FDA’s standards for current good manufacturing practices, including applicable requirements contained in 21 C.F.R. Parts 210, 211, 600-680 and 1271, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States.

(h) No laboratory or manufacturing site owned by Homology or its Subsidiaries, and to the Knowledge of Homology, no manufacturing site of a contract manufacturer or laboratory, with respect to any Homology Product Candidate, (i) is subject to a Drug Regulatory Agency shutdown or import or export prohibition or (ii) has since January 1, 2020, received any unresolved Form FDA 483, notice of violation, warning letter, untitled letter, or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting material noncompliance with any applicable Law, and, to the Knowledge of Homology, neither the FDA nor any other Governmental Authority is considering such action.

4.15 Legal Proceedings; Orders.

(a) Except as set forth in Section 4.15 of the Homology Disclosure Schedule, there is no pending Legal Proceeding and, to the Knowledge of Homology, no Person has threatened in writing to commence any Legal Proceeding: (i) that involves Homology or any of its Subsidiaries or any Homology Associate (in his or her capacity as such) or any of the material assets owned or used by Homology or any of its Subsidiaries or (ii) that challenges, or that may have the effect of preventing, delaying, making illegal or otherwise interfering with, the Contemplated Transactions.

 

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(b) There is no Order to which Homology or any of its Subsidiaries, or any of the material assets owned or used by Homology or any of its Subsidiaries is subject. To the Knowledge of Homology, no officer or other Key Employee of Homology or any of its Subsidiaries is subject to any Order that prohibits such officer or employee from engaging in or continuing any conduct, activity or practice relating to the business of Homology or any of its Subsidiaries or to any material assets owned or used by Homology or any of its Subsidiaries.

4.16 Tax Matters.

(a) Each of Homology and each of its Subsidiaries has timely filed all income Tax Returns and all other material Tax Returns that were required to be filed by or with respect to it under applicable Law. All such Tax Returns were correct and complete in all material respects and have been prepared in material compliance with all applicable Law. Subject to exceptions as would not be material, no claim has ever been made by a Governmental Authority in a jurisdiction where Homology or any of its Subsidiaries does not file a particular type of Tax Return that Homology or any of its Subsidiaries is subject to taxation by that jurisdiction that would require the filing of such a Tax Return.

(b) All material amounts of Taxes due and owing by Homology and each of its Subsidiaries (whether or not shown on any Tax Return) have been timely paid. The unpaid Taxes of Homology and each of its Subsidiaries for periods (or portions thereof) ending on or prior to the date of the Homology Balance Sheet do not materially exceed the accruals for current Taxes set forth on the Homology Balance Sheet. Since the date of the Homology Balance Sheet, neither Homology nor any of its Subsidiaries has incurred any material Liability for Taxes outside the Ordinary Course of Business or otherwise inconsistent with past custom and practice.

(c) Each of Homology and each of its Subsidiaries has withheld and paid to the appropriate Governmental Authority all material Taxes required to have been withheld and paid in connection with any amounts paid or owing to any employee, independent contractor, creditor, stockholder, or other third party.

(d) There are no Encumbrances for material Taxes (other Encumbrances described in clause (i) of the definition of “Permitted Encumbrances”) upon any of the assets of Homology or any of its Subsidiaries.

(e) No deficiencies for a material amount of Taxes with respect to Homology or any of its Subsidiaries have been claimed, proposed or assessed by any Governmental Authority in writing that have not been timely paid in full. There are no pending (or, based on written notice, threatened) material audits, assessments, examinations or other actions for or relating to any Liability in respect of Taxes of Homology or any of its Subsidiaries. Neither Homology nor any of its Subsidiaries has waived any statute of limitations in respect of material Taxes or agreed to any extension of time with respect to a material Tax assessment or deficiency.

(f) Neither Homology nor any of its Subsidiaries is a party to any Tax allocation, Tax sharing or similar agreement (including indemnity arrangements), other than Ordinary Course Agreements.

(g) Neither Homology nor any of its Subsidiaries has been a member of an affiliated group filing a consolidated U.S. federal income Tax Return (other than a group the common parent of which is Homology). Neither Homology nor any of its Subsidiaries has any material Liability for the Taxes of any Person (other than Homology and Merger Sub) under Treasury Regulations Section 1.1502-6 (or any similar provision of state, local, or foreign law), as a transferee or successor, or by Contract (other than an Ordinary Course Agreement).

(h) Neither Homology nor any of its Subsidiaries has distributed stock of another Person, or has had its stock distributed by another Person, in a transaction that was purported or intended to be governed in whole or in part by Section 355 of the Code or Section 361 of the Code.

(i) Neither Homology nor any of its Subsidiaries has entered into any transaction identified as a “reportable transaction” for purposes of Treasury Regulations Section 1.6011-4(b)(2).

 

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(j) Neither Homology nor any of its Subsidiaries will be required to include any material item of income or gain in, or exclude any material item of deduction or loss from, taxable income for any taxable period (or portion thereof) ending after the Closing Date as a result of any: (i) change in, or use of improper, method of accounting for a taxable period ending on or prior to the Closing Date; (ii) “closing agreement” as described in Section 7121 of the Code (or any corresponding or similar provision of state, local or foreign income Tax law) executed on or prior to the Closing Date; (iii) installment sale or open transaction disposition made on or prior to the Closing Date; (iv) prepaid amount, advance payments or deferred revenue received or accrued on or prior to the Closing Date; or (v) intercompany transaction or excess loss amount described in Treasury Regulations under Section 1502 of the Code (or any corresponding or similar provision of state, local or foreign income Tax Law).

(k) Section 4.16(k) of the Homology Disclosure Schedule sets forth the entity classification of Homology and each of its Subsidiaries for U.S. federal income tax purposes. Neither Homology nor any of its Subsidiaries has made an election or taken any other action to change its federal and state income tax classification from such classification.

(l) Neither Homology nor any of its Subsidiaries has taken or knowingly failed to take any action, nor to the Knowledge of Homology, are there any facts or circumstances, in each case, that would reasonably be expected to prevent or impede the Merger from qualifying for the Intended Tax Treatment.

4.17 Employee and Labor Matters; Benefit Plans.

(a) Section 4.17(a) of the Homology Disclosure Schedule contains a complete and accurate list of all Homology employees as of the date of this Agreement, setting forth for each employee: job title; classification as exempt or non-exempt for wage and hour purposes; annual base salary, hourly rate or other rates of compensation; bonus potential; full-time or part-time status; date of hire; business location; status (i.e., active or inactive and if inactive, the type of leave and estimated duration); and any visa or work permit status and the date of expiration, if applicable.

(b) Section 4.17(b) of the Homology Disclosure Schedule contains a complete and accurate list as of the date hereof of all of the independent contractors, consultants, temporary employees, leased employees or other agents employed or used by Homology and classified by Homology as other than employees, or compensated other than through wages paid by Homology through Homology’s payroll department (“Homology Contingent Workers”), showing for each Homology Contingent Worker such individual’s engagement date, role in the business, work location, and fee or compensation arrangements.

(c) Neither Homology nor any of its Subsidiaries is a party to, bound by the terms of, or has a duty to bargain under, any collective bargaining agreement or other Contract with a labor union, works council or labor organization representing any Homology Associate, and there are no labor unions, works council or labor organizations representing or, to the Knowledge of Homology, purporting to represent or seeking to represent any Homology Associates, including through the filing of a petition for representation election.

(d) Section 4.17(d) of the Homology Disclosure Schedule lists all material Homology Employee Plans.

(e) As applicable with respect to each material Homology Employee Plan, Homology has made available to Q32, true and complete copies of (i) the plan document, including all amendments thereto, and in the case of an unwritten Employee Plan, a written description of all material terms thereof, (ii) all related trust instruments or other funding-related documents and insurance contracts, (iii) the summary plan description and each summary of material modifications thereto, (iv) the financial statements for the most recent year for which such financial statements are available (in audited form, if available or required by ERISA) and, where applicable, annual reports with any Governmental Authority (e.g., Form 5500 and all schedules thereto), (v) the most recent IRS determination or opinion letter, (vi) written results of any required compliance testing for the three most recent plan years, and (vii) all material, non-routine notices, filings or correspondence during the past three years with any Governmental Authority.

 

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(f) Each Homology Employee Plan that is intended to be qualified under Section 401(a) of the Code has received a favorable determination letter or may rely on a favorable opinion letter with respect to such qualified status from the IRS to the effect that such plan is qualified under Section 401(a) of the Code and the related trust is exempt from federal income Taxes under Section 501(a) of the Code. To the Knowledge of Homology, nothing has occurred that would reasonably be expected to cause the loss of the qualified status of any such Homology Employee Plan or the Tax exempt status of any related trust.

(g) Each Homology Employee Plan has been established, maintained and operated in compliance, in all material respects, with its terms and all applicable Laws, including, without limitation, the Code and ERISA. No Legal Proceeding (other than those relating to routine claims for benefits) is pending or, to the Knowledge of Homology, threatened with respect to any Homology Employee Plan. All material payments and/or contributions required to have been made with respect to all Homology Employee Plans have been made in accordance with the terms of the applicable Homology Employee Plan and applicable Law in all material respects and neither the Homology nor any Homology ERISA Affiliate has any material Liability for any such unpaid contributions with respect to any Homology Employee Plan.

(h) Neither Homology, any of its Subsidiaries nor any of their ERISA Affiliates maintains, contributes to or is required to contribute to, or has any Liability with respect to (i) any “employee benefit plan” (within the meaning of Section 3(2) of ERISA) that is or was subject to Title IV or Section 302 of ERISA or Section 412 of the Code, (ii) a Multiemployer Plan, (iii) any Multiple Employer Plan, or (iv) any Multiple Employer Welfare Arrangement.

(i) No Homology Employee Plan provides for medical or other welfare benefits to any service provider beyond termination of service or retirement, other than (i) pursuant to COBRA or an analogous state law requirement (the full cost of which is borne by such Person or such Person’s dependents or beneficiaries) or (ii) continuation coverage through the end of the month in which such termination or retirement occurs.

(j) No Homology Employee Plan is subject to any law of a foreign jurisdiction outside of the United States.

(k) Each Homology Employee Plan that constitutes in any part a nonqualified deferred compensation plan within the meaning of Section 409A of the Code has complied in all material respects with Section 409A of the Code, to the extent applicable, and no compensation has been or would reasonably be expected to be includable in the gross income of any Homology Associate as a result of the operation of Section 409A of the Code.

(l) Homology and its Subsidiaries are, and since January 1, 2020 have been, in compliance in all material respects with all applicable Laws respecting labor, employment and employment practices, including terms and conditions of employment, worker classification, tax withholding, unemployment compensation, workers’ compensation, prohibited discrimination, harassment, equal employment, fair employment practices, meal and rest periods, work authorization and immigration status, employee safety and health, wages (including overtime wages), pay equity, affirmative action, restrictive covenants, compensation, and hours of work. There are no Legal Proceedings pending or, to the Knowledge of Homology, threatened against Homology or any of its Subsidiaries relating to any labor or employment matters or any Homology Associate. Homology is not a party to a conciliation agreement, consent decree or other agreement or Order with any federal, state, or local agency or Governmental Authority with respect to employment practices.

(m) Since January 1, 2020, (i) Homology has not taken any action which would constitute a “plant closing”, “collective dismissal”, “group dismissal”, “group termination”, “mass termination”, or “mass layoff” within the meaning of the WARN Act, (ii) issued any written notification of a plant closing or mass layoff required by the WARN Act (nor has Homology or any of its Subsidiaries been under any requirement or obligation to issue any such notification), or (iii) incurred any Liability or obligation under the WARN Act that remains unsatisfied.

(n) Since January 1, 2020, there has never been, nor to the Knowledge of Homology has there been any threat of, any strike, slowdown, work stoppage, lockout, job action, union, organizing activity, question

 

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concerning representation or any similar activity or dispute, affecting Homology or its Subsidiaries. No event has occurred within the past six (6) months, and, to the Knowledge of Homology, no condition or circumstance exists, that would reasonably be expected to give rise to or provide a basis for the commencement of any such strike, slowdown, work stoppage, lockout, job action, union organizing activity, question concerning representation or any similar activity or dispute.

(o) There is no contract, agreement, plan or arrangement to which Homology or any of its Subsidiaries is a party or by which it is bound to make any payment or compensate any Homology Associate for Taxes incurred pursuant to the Code, including, but not limited to, Section 4999 or Section 409A of the Code.

(p) Neither the execution and delivery of this Agreement, the shareholder approval of this Agreement, nor the consummation of the Contemplated Transactions (either alone or in conjunction with any other event, including without limitation, a termination of employment) will result in any (i) payment (including severance, forgiveness of indebtedness or otherwise) or benefit becoming due to Homology Associate, (ii) increase in any benefits or the compensation payable under any Homology Employee Plan, (iii) acceleration of the time of payment, funding or vesting of any such compensation or benefits or any loan forgiveness, (iv) restriction on the right of Homology or any of its Subsidiaries or, after the consummation of Contemplated Transactions, the Surviving Corporation, to merge, amend, terminate or transfer any Homology Employee Plan, or (v) “excess parachute payment” (within the meaning of Section 280G of the Code).

4.18 Environmental Matters. Since January 1, 2020, Homology and each of its Subsidiaries has complied with all applicable Environmental Laws, which compliance includes the possession by Homology of all permits and other Governmental Authorizations required under applicable Environmental Laws and compliance with the terms and conditions thereof, except for any failure to be in compliance that, individually or in the aggregate, would not result in a Homology Material Adverse Effect. Neither Homology nor any of its Subsidiaries has received since January 1, 2020, any written notice or other communication (in writing or otherwise), whether from a Governmental Authority, citizens group, employee or otherwise, that alleges that Homology or any of its Subsidiaries is not in compliance with any Environmental Law, and, to the Knowledge of Homology, there are no circumstances that may prevent or interfere with Homology’s or any of its Subsidiaries’ compliance with any Environmental Law in the future, except where such failure to comply would not reasonably be expected to have a Homology Material Adverse Effect. To the Knowledge of Homology: (a) no current or prior owner of any property leased or controlled by Homology or any of its Subsidiaries has received since January 1, 2020, any written notice or other communication relating to property owned or leased at any time by Homology or any of its Subsidiaries, whether from a Governmental Authority, citizens group, employee or otherwise, that alleges that such current or prior owner or Homology or any of its Subsidiaries is not in compliance with or violated any Environmental Law relating to such property and (b) neither Homology nor any of its Subsidiaries has any material Liability under any Environmental Law.

4.19 Insurance. Homology has made available to Q32 accurate and complete copies of all material insurance policies and all material self-insurance programs and arrangements relating to the business, assets, liabilities and operations of Homology and its Subsidiaries (including Merger Sub). Each of such insurance policies is in full force and effect and Homology and its Subsidiaries (including Merger Sub) are in compliance in all material respects with the terms thereof. Other than customary end of policy notifications from insurance carriers, since January 1, 2020, neither Homology nor any of its Subsidiaries has received any notice or other communication regarding any actual or possible: (a) cancellation or invalidation of any insurance policy or (b) refusal or denial of any coverage, reservation of rights or rejection of any material claim under any insurance policy. Each of Homology and its Subsidiaries (including Merger Sub) has provided timely written notice to the appropriate insurance carrier(s) of each Legal Proceeding pending against Homology or such Subsidiary for which Homology or such Subsidiary has insurance coverage, and no such carrier has issued a denial of coverage or a reservation of rights with respect to any such Legal Proceeding, or informed Homology or any of its Subsidiaries of its intent to do so.

 

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4.20 Transactions with Affiliates. Except as set forth in the Homology SEC Documents filed prior to the date of this Agreement, since the date of Homology’s last proxy statement filed in 2022 with the SEC, no event has occurred that would be required to be reported by Homology pursuant to Item 404 of Regulation S-K promulgated by the SEC. Section 4.20 of the Homology Disclosure Schedule identifies each Person who is (or who may be deemed to be) an Affiliate of Homology as of the date of this Agreement.

4.21 No Financial Advisors. Except as set forth on Section 4.21 of the Homology Disclosure Schedule, no broker, finder or investment banker is entitled to any brokerage fee, finder’s fee, opinion fee, success fee, transaction fee or other fee or commission in connection with the Contemplated Transactions based upon arrangements made by or on behalf of Homology.

4.22 Valid Issuance; No Bad Actor. The Homology Common Stock to be issued in the Merger will, when issued in accordance with the provisions of this Agreement, be validly issued, fully paid and nonassessable. To the Knowledge of Homology, as of the date of this Agreement and as of the Closing, no “bad actor” disqualifying event described in Rule 506(d)(l)(i)-(viii) of the Securities Act (a “Disqualifying Event”) is applicable to Homology or, to Homology’s Knowledge, any Homology Covered Person, except for a Disqualifying Event as to which Rule 506(d)(2)(ii-iv) or (d)(3) of the Securities Act is applicable.

4.23 Privacy and Data Security.

(a) Homology and its Subsidiaries have complied with all applicable Privacy Laws and the applicable terms of any Homology Contracts relating to privacy, security, collection or use of Personal Information of any individuals (including clinical trial participants, patients, patient family members, caregivers or advocates, physicians and other health care professionals, clinical trial investigators, researchers, pharmacists) that interact with Homology or any of its Subsidiaries in connection with the operation of Homology’s and its Subsidiaries’ business, except for such noncompliance as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Homology Material Adverse Effect. To the Knowledge of Homology, Homology has implemented and maintains reasonable written policies and procedures, satisfying the requirements of applicable Privacy Laws and Homology Contracts, concerning the privacy, security, collection and use of Personal Information (“Homology Privacy Policies”) and has complied with the same, except for such noncompliance as has not to the Knowledge of Q32 had, and would not reasonably be expected to have, individually or in the aggregate, a Q32 Material Adverse Effect. To the Knowledge of Homology, as of the date hereof, no claims have been asserted or threatened against Homology by any Person alleging a violation of Privacy Laws, Privacy Policies and/or the applicable terms of any Homology Contracts relating to privacy, security, collection or use of Personal Information of any individuals and Homology has not received written notice of any of the same. To the Knowledge of Homology, there have been no data security incidents, personal data breaches or other adverse events or incidents related to Personal Information or Homology data in the custody or control of Homology or any service provider acting on behalf of Homology, in each case where such incident, breach or event would result in a notification obligation to any Person under applicable law or pursuant to the terms of any Homology Contract.

(b) The information technology assets and equipment of Homology and its Subsidiaries (collectively, “Homology IT Systems”) are adequate for, and operate and perform in all material respects as required in connection with the operation of the business of Homology and its Subsidiaries as currently conducted, and to the Knowledge of Homology, free and clear of all material bugs, errors, defects, Trojan horses, time bombs, malware and other corruptants. Homology and its Subsidiaries have implemented and maintain commercially reasonable physical, technical and administrative safeguards to protect Personal Information processed by or on behalf of Homology and its Subsidiaries, any other material confidential information and the integrity and security of Homology IT Systems used in connection with their businesses, and during the past three years, there have been no breaches, violations, outages or unauthorized uses of or accesses to same, except for those that have been remedied without material cost or liability or the duty to notify any other Person.

 

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4.24 No Other Representations or Warranties. Homology hereby acknowledges and agrees that, except for the representations and warranties contained in this Agreement, neither Homology nor any of its Subsidiaries nor any other person on behalf of Homology or its Subsidiaries makes any express or implied representation or warranty with respect to Homology or its Subsidiaries or with respect to any other information provided to Q32, its stockholders or any of its Affiliates in connection with the Contemplated Transactions, and (subject to the express representations and warranties of Homology set forth in Article IV (in each case as qualified and limited by the Homology Disclosure Schedule)) none of Q32, its Representatives, stockholders or members, has relied on any such information (including the accuracy or completeness thereof).

ARTICLE V

COVENANTS

5.1 Conduct of Q32’s Business. From the date hereof until the earlier of the Effective Time and the termination of this Agreement in accordance with Article VIII (the “Pre-Closing Period”), except as set forth on Section 5.1 of the Q32 Disclosure Schedule, as required by applicable Law, as otherwise provided by this Agreement and the Contemplated Transactions or with Homology’s prior written consent (not to be unreasonably withheld, conditioned or delayed), Q32 shall, and shall cause its Subsidiaries to, use their commercially reasonable efforts to conduct its operations in the Ordinary Course of Business and to preserve intact the present business organizations and goodwill of the business and the present relationships of the business with material customers and suppliers. Without limiting the generality of the foregoing, during the Pre-Closing Period, except as set forth in Section 5.1 of the Q32 Disclosure Schedule, as required by applicable Law, as otherwise specifically provided by this Agreement and the Contemplated Transactions or with Homology’s prior written consent (not to be unreasonably withheld, conditioned or delayed), Q32 shall not, and shall cause its Subsidiaries not to:

(a) sell, lease, license or otherwise dispose of any material assets of Q32, or in either case, any interests therein, except (i) pursuant to existing Contracts, (ii) for sales or licensing of products to customers or (iii) otherwise in the Ordinary Course of Business;

(b) take any action with respect to any equity interests of Q32 or any of its Subsidiaries, including any issuance, sale, transfer, redemption, repurchase, recapitalization, adjustment, split, combination, reclassification, dividend, distribution or any other action in respect thereof;

(c) create, incur, assume, guarantee or repay (other than any mandatory repayments) any indebtedness, other than in the Ordinary Course of Business or as approved by the Q32 Board;

(d) issue, deliver, sell, grant, pledge, transfer, subject to any Encumbrance or dispose of any Q32 Capital Stock or the securities of any Subsidiary of Q32;

(e) create or otherwise incur any Encumbrance on any material asset of Q32 or any of its Subsidiaries, other than Permitted Encumbrances;

(f) make any loans, advances or capital contributions to, or investments in, any Person other than Q32;

(g) adversely amend or otherwise adversely modify in any material respect or terminate (excluding any expiration in accordance with its terms) any Contract listed in Section 3.12 of the Q32 Disclosure Schedule, other than any amendment or modification entered into in the Ordinary Course of Business and containing terms not materially less favorable to Q32 than the terms of such Contract in effect as of the date of this Agreement;

(h) enter into any Contract that would be required to be disclosed in Section 3.12 of the Q32 Disclosure Schedule if such Contract were in effect as of the date of this Agreement, other than any such Contract entered into in the Ordinary Course of Business;

 

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(i) except as required by any Q32 Employee Plan or as required by applicable Law, (i) increase any salary, wage or other compensation or benefit to, or enter into or amend any employment, retention, change-in-control, termination or severance agreement with, any Q32 Associate, other than annual increases in base compensation in the Ordinary Course of Business with respect to employees whose annual base compensation is less than $500,000 and provided that such increases do not, individually or in the aggregate, result in any material increase in costs, obligations or liabilities for Q32 and its Subsidiaries, (ii) grant or pay any bonuses to any Q32 Associate, other than in the Ordinary Course of Business, or (iii) establish, enter into or adopt any new material Q32 Employee Plan or any plan, program, policy, agreement or arrangement that would be a material Q32 Employee Plan if it was in effect on the date hereof or amend or modify, in a manner that would, individually or in the aggregate, materially increase costs, obligations or liabilities for Q32 and its Subsidiaries or the Surviving Corporation, any existing Q32 Employee Plan or accelerate the vesting of any compensation (including stock options, restricted stock, restricted stock units, phantom units, warrants, other shares of capital stock or rights of any kind to acquire any shares of capital stock or equity-based awards) for the benefit of any Q32 Associate other than in the Ordinary Course of Business;

(j) adopt, enter into, amend or terminate any collective bargaining agreement or Contract with any labor union, works council or labor organization;

(k) settle any material Legal Proceeding involving Q32 or any of its Subsidiaries or relating to the transactions contemplated by this Agreement;

(l) make or change any material Tax election, change any annual Tax accounting period, enter into any closing agreement with a Governmental Authority with respect to material Taxes or settle any Tax claim with respect to material Taxes, in each case, except if such action would not reasonably be expected to have a material and adverse effect on Q32 following the Closing;

(m) take any action, or knowingly fail to take any action, where such action or failure to act would reasonably be expected to prevent the Merger from qualifying for the Intended Tax Treatment;

(n) make any material change in any method of financial accounting or financial accounting practice of Q32 or any of its Subsidiaries, except for any such change required by reason of a change in GAAP or other applicable financial accounting standards;

(o) other than in connection with actions contemplated by this Agreement, adopt, approve, consent to or propose any change in the Organizational Documents of Q32 or any of its Subsidiaries; or

(p) agree or commit to do any of the foregoing.

Notwithstanding the generality of the foregoing, nothing set forth in this Section 5.1 shall restrict Q32’s rights to effectuate the Concurrent Financing upon the terms set forth in the Subscription Agreement on the date hereof. Nothing contained in this Agreement shall give Homology, directly or indirectly, the right to control or direct the operations of Q32 prior to the Effective Time. Prior to the Effective Time, Q32 shall exercise, consistent with the terms and conditions of this Agreement, complete unilateral control and supervision over its business operations.

5.2 Conduct of Homology’s Business. During the Pre-Closing Period, except as set forth on Section 5.2 of the Homology Disclosure Schedule, as required by applicable Law, as otherwise provided by this Agreement and the Contemplated Transactions or with Q32’s prior written consent (not to be unreasonably withheld, conditioned or delayed), Homology shall, and shall cause its Subsidiaries to, use their commercially reasonable efforts to conduct its operations in the Ordinary Course of Business and to preserve intact the present business organizations and goodwill of the business and the present relationships of the business with material customers and suppliers. Without limiting the generality of the foregoing, during the Pre-Closing Period, except as set forth

 

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in Section 5.2 of the Homology Disclosure Schedule, as required by applicable Law, as otherwise specifically provided by this Agreement and the Contemplated Transactions or with Q32’s prior written consent (not to be unreasonably withheld, conditioned or delayed), Homology shall not, and shall cause its Subsidiaries not to:

(a) sell, lease, license or otherwise dispose of any material assets of Homology, or in either case, any interests therein, except (i) pursuant to existing Contracts, (ii) for sales or licensing of products to customers or (iii) otherwise in the Ordinary Course of Business;

(b) except for the issuance of securities under this Agreement, take any action with respect to any equity interests of Homology or any of its Subsidiaries, including any issuance, sale, transfer, redemption, repurchase, recapitalization, adjustment, split, combination, reclassification, dividend, distribution or any other action in respect thereof;

(c) create, incur, assume, guarantee or repay (other than any mandatory repayments) any indebtedness;

(d) issue, deliver, sell, grant, pledge, transfer, subject to any Encumbrance or dispose of any Homology Common Stock or the securities of any Subsidiary of Homology;

(e) create or otherwise incur any Encumbrance on any material asset of Homology, other than Permitted Encumbrances;

(f) make any loans, advances or capital contributions to, or investments in, any Person other than Homology;

(g) adversely amend or otherwise adversely modify in any material respect or terminate (excluding any expiration in accordance with its terms) any Contract listed in Section 4.13 of the Homology Disclosure Schedule, other than any amendment or modification entered into in the Ordinary Course of Business and containing terms, not materially less favorable to Homology than the terms of such Contract in effect as of the date of this Agreement;

(h) enter into any Contract that would be required to be disclosed in Section 4.13 of the Homology Disclosure Schedule if such Contract were in effect as of the date of this Agreement, other than any such Contract entered into in the Ordinary Course of Business;

(i) except as required by any Homology Employee Plan, applicable Law or this Agreement, (i) increase any salary, wage or other compensation or benefit to, or enter into or amend any employment, retention, change-in-control, termination or severance agreement with, any Homology Associate, other than as set forth in Section 5.2(i)of the Homology Disclosure Schedule and provided that such increases do not, individually or in the aggregate, result in any material increase in costs, obligations or liabilities for Homology and its Subsidiaries, (ii) grant or pay any bonuses to any Homology Associate, (iii) establish, enter into or adopt any new Homology Employee Plan or any plan, program, policy, agreement or arrangement that would be a material Homology Employee Plan if it was in effect on the date hereof or amend or modify, in a manner that would, individually or in the aggregate, materially increase costs, obligations or liabilities for Homology and its Subsidiaries or the Surviving Corporation, any existing Homology Employee Plan or accelerate the vesting of any compensation (including stock options, restricted stock, restricted stock units, phantom units, warrants, other shares of capital stock or rights of any kind to acquire any shares of capital stock or equity-based awards) for the benefit of any Homology Associate, (iv) grant to any Homology Associate any right to receive, or pay to any Homology Associate, any severance, change in control, transaction, retention, termination or similar compensation or benefits or increases therein, (v) take any action to accelerate any payment or benefit, or the funding of any payment or benefit, payable or to be provided to any Homology Associate, (vi) grant any new long-term incentive or equity-based awards, or amend or modify the terms of any such outstanding awards under any Homology Employee Plan or (vii) hire, terminate (other than for cause), promote or change the employment status or title of any Homology Associate;

 

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(j) adopt, enter into, amend or terminate any collective bargaining agreement or Contract with any labor union, works council or labor organization;

(k) settle any material Legal Proceeding involving Homology or relating to the transactions contemplated by this Agreement;

(l) make or change any material Tax election, change any annual Tax accounting period, enter into any closing agreement with a Governmental Authority with respect to material Taxes or settle any Tax claim with respect to material Taxes, in each case, except if such action would not reasonably be expected to have a material and adverse effect on Homology following the Closing;

(m) take any action, or knowingly fail to take any action, where such action or failure to act would reasonably be expected to prevent the Merger from qualifying for the Intended Tax Treatment;

(n) make any material change in any method of financial accounting or financial accounting practice of Homology, except for any such change required by reason of a change in GAAP or other applicable financial accounting standards;

(o) other than in connection with actions contemplated by this Agreement, adopt, approve, consent to or propose any change in the Organizational Documents of Homology; or

(p) agree or commit to do any of the foregoing.

Notwithstanding the generality of the foregoing, nothing set forth in this Section 5.2 shall restrict Homology’s right to (i) effectuate any Legacy Asset Disposition or (ii) encumber, abandon or not file, prosecute, maintain, defend, or enforce any Homology Legacy IP Rights (“Abandoned Homology Legacy IP Rights”). Nothing contained in this Agreement shall give Q32, directly or indirectly, the right to control or direct the operations of Homology prior to the Effective Time. Prior to the Effective Time, Homology shall exercise, consistent with the terms and conditions of this Agreement, complete unilateral control and supervision over its business operations.

5.3 Access and Investigation.

(a) Subject to the terms of the Confidentiality Agreement, which the Parties agree will continue in full force following the date of this Agreement, during the Pre-Closing Period, upon reasonable notice, Homology, on the one hand, and Q32, on the other hand, shall and shall use commercially reasonable efforts to cause such Party’s Representatives to: (i) provide the other Party and such other Party’s Representatives with reasonable access during normal business hours to such Party’s Representatives, personnel and assets and to all existing books, records, Tax Returns, work papers and other documents and information relating to such Party and its Subsidiaries, (ii) provide the other Party and such other Party’s Representatives with such copies of the existing books, records, Tax Returns, work papers, product data, and other documents and information relating to such Party and its Subsidiaries, and with such additional financial, operating and other data and information regarding such Party and its Subsidiaries as the other Party may reasonably request, (iii) permit the other Party’s officers and other employees to meet, upon reasonable notice and during normal business hours, with the chief financial officer and other officers and managers of such Party responsible for such Party’s financial statements and the internal controls of such Party to discuss such matters as the other Party may deem reasonably necessary or appropriate, and (iv) provide the other Party with copies, when available, of unaudited financial statements or management accounts, and communications sent by or on behalf of such Party to its stockholders or any material notice, report or other document filed with or sent to or received from any Governmental Authority in connection with the Contemplated Transactions. Any investigation conducted by either Homology or Q32 pursuant to this Section 5.3 shall be conducted in such manner as not to interfere unreasonably with the conduct of the business of the other Party.

 

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(b) Notwithstanding anything herein to the contrary in this Section 5.3, no access or examination contemplated by this Section 5.3 shall be permitted to the extent that it would require any Party or its Subsidiaries to waive the attorney-client privilege or attorney work product privilege, or violate any applicable Law; provided, that such Party or its Subsidiary (i) shall be entitled to withhold only such information that may not be provided without causing such violation or waiver, (ii) shall provide to the other Party all related information that may be provided without causing such violation or waiver (including, to the extent permitted, redacted versions of any such information) and (iii) shall enter into such effective and appropriate joint-defense agreements or other protective arrangements as may be reasonably requested by the other Party in order that all such information may be provided to the other Party without causing such violation or waiver.

5.4 No Solicitation.

(a) Each of Homology and Q32 agrees that, during the Pre-Closing Period, neither it nor any of its Subsidiaries shall, nor shall it or any of its Subsidiaries authorize any of its Representatives to, directly or indirectly: (i) solicit, initiate or knowingly encourage, induce or facilitate the communication, making, submission or announcement of any Acquisition Proposal or Acquisition Inquiry or take any action otherwise inconsistent with past practice that could reasonably be expected to lead to an Acquisition Proposal or Acquisition Inquiry, (ii) furnish any non-public information regarding such Party to any Person (other than Q32 or Homology) in connection with or in response to an Acquisition Proposal or Acquisition Inquiry, (iii) engage in discussions or negotiations with any Person with respect to any Acquisition Proposal or Acquisition Inquiry, (iv) approve, endorse or recommend any Acquisition Proposal (subject to Section 5.9), (v) execute or enter into any letter of intent or any Contract contemplating or otherwise relating to any Acquisition Transaction or (vi) publicly propose to do any of the foregoing; provided, however, that, notwithstanding anything contained in this Section 5.3(a) and subject to compliance with this Section 5.3(a), prior to the approval of this Agreement by Homology’s stockholders (i.e., the Required Homology Stockholder Vote), Homology may furnish non-public information regarding Homology and its Subsidiaries to, and enter into discussions or negotiations with, any Person in response to a bona fide written Acquisition Proposal by Homology which the Homology Board determines in good faith, after consultation with Homology’s financial advisors and outside legal counsel, constitutes, or is reasonably likely to result in, a Superior Offer (and is not withdrawn) if: (A) neither Homology nor any Representative of Homology shall have breached this Section 5.3(a) in any material respect, (B) the Homology Board concludes in good faith based on the advice of outside legal counsel, that the failure to take such action would reasonably be expected to be inconsistent with the fiduciary duties of the Homology Board under applicable Law, (C) as promptly as possible after (and in any event within forty-eight hours of) initially furnishing any such non-public information to, or entering into discussions with, such Person, Homology gives Q32 written notice of the identity of such Person to Q32, and of Homology’s intention to furnish non-public information to, or enter into discussions with, such Person, (D) Homology receives from such Person an executed Acceptable Confidentiality Agreement and (E) as promptly as possible after (and in any event within forty-eight hours of) furnishing any such non-public information to such Person, Homology furnishes such non-public information to Q32 (to the extent such information has not been previously furnished by Homology to Q32). Notwithstanding anything to the contrary set forth in this Agreement, Homology and its Representatives may, in any event (without the Homology Board having to make a determination in clause (B) of the preceding sentence), contact any person to (i) seek to clarify and understand the terms and conditions of any Acquisition Proposal made by such Person solely to determine whether such Acquisition Proposal constitutes, or is reasonably likely to result in, a Superior Offer and (ii) inform such Person that has made or, to the knowledge of Homology is considering making an Acquisition Proposal. Without limiting the generality of the foregoing, Homology acknowledges and agrees that, in the event any Representative of Homology takes any action that, if taken by Homology, would constitute a breach of this Section 5.3(a) by Homology, the taking of such action by such Representative shall be deemed to constitute a breach of this Section 5.3(a) by Homology for purposes of this Agreement.

(b) If any Party or any Representative of such Party receives an Acquisition Proposal or Acquisition Inquiry at any time during the Pre-Closing Period, then such Party shall promptly (and in no event later than one

 

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Business Day after such Party becomes aware of such Acquisition Proposal or Acquisition Inquiry) advise the other Party orally and in writing of such Acquisition Proposal or Acquisition Inquiry (including the identity of the Person making or submitting such Acquisition Proposal or Acquisition Inquiry, and provide a copy of the Acquisition Proposal or Acquisition Inquiry, of if the Acquisition Proposal or Acquisition Inquiry is not written, the terms thereof). Such Party shall keep the other Party reasonably informed with respect to the status and terms of any such Acquisition Proposal or Acquisition Inquiry and any material modification or material proposed modification thereto. In addition to the foregoing, each Party shall provide the other Party with at least forty-eight hours written notice of a meeting of its board of directors (or any committee thereof) at which its board of directors (or any committee thereof) is reasonably expected to consider an Acquisition Proposal or Acquisition Inquiry it has received.

(c) Each Party shall immediately cease and cause to be terminated any existing discussions, negotiations and communications with any Person that relate to any Acquisition Proposal or Acquisition Inquiry as of the date of this Agreement and request the destruction or return of any non-public information provided to such Person.

5.5 Notification of Certain Matters.

(a) During the Pre-Closing Period, each of Q32, on the one hand, and Homology, on the other hand, shall promptly notify the other (and, if in writing, furnish copies of) if any of the following occurs: (i) any notice or other communication is received from any Person alleging that the Consent of such Person is or may be required in connection with any of the Contemplated Transactions, (ii) any Legal Proceeding against or involving or otherwise affecting such Party or its Subsidiaries is commenced, or, to the Knowledge of such Party, threatened against such Party or, to the Knowledge of such Party, any director, officer or Key Employee of such Party, (iii) such Party becomes aware of any inaccuracy in any representation or warranty made by such Party in this Agreement or (iv) the failure of such Party to comply with any covenant or obligation of such Party; in each case that could reasonably be expected to make the timely satisfaction of any of the conditions set forth in Article VI impossible or materially less likely. No such notice shall be deemed to supplement or amend the Q32 Disclosure Schedule or the Homology Disclosure Schedule for the purpose of (A) determining the accuracy of any of the representations and warranties made by Q32 or Homology in this Agreement or (B) determining whether any condition set forth in Article VI has been satisfied. Any failure by either Party to provide notice pursuant to this Section 5.5 shall not be deemed to be a breach for purposes of Section 6.2(b) or 6.3(b), as applicable, unless such failure to provide such notice was knowing and intentional.

(b) During the Pre-Closing Period, Homology shall use reasonable best efforts to consult with Q32 during the negotiation process for, and prior to taking any material action with respect to, any amendment to, sublicense or the potential early termination of the Homology Lease, and shall consider any input received from Q32 in good faith prior to taking any such action.

(c) During the Pre-Closing Period, Homology shall provide to Q32 an updated list of Abandoned Homology Legacy IP Rights on a monthly basis starting from December 1, 2023, with the final such list to be delivered within three (3) days preceding Closing.

5.6 Legacy Asset Disposition.

(a) Prior to the Closing Date, Homology shall be entitled, but under no obligation, to sell, transfer, license, assign or otherwise divest any or all of the assets and rights primarily relating to Homology’s HMI-103 (Adult/Pediatric PKU), HMI-203 (MPS II (Hunter Syndrome)), HMI-204 (MLD), Capsids and AAVHSC Platform (the “Legacy Assets”), including any equity interests held directly or indirectly by Homology in Oxford Biomedica Solutions, LLC or its affiliates (the “Oxford Assets”) in a transaction or series of transactions (the “Legacy Asset Disposition”), provided that Homology as promptly as practicable thereafter notify Q32 of any such Legacy Asset Disposition. Each Party acknowledges that Homology may, in contemplation of the Legacy Asset Disposition, (a) establish one or more Subsidiaries to hold the Legacy Assets, (b) transfer to any such Subsidiary

 

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any or all of the Legacy Assets and the liabilities and obligations related thereto and (c) take such other steps that are reasonably necessary to prepare for the Legacy Asset Disposition. For clarity, if Homology transfers the Legacy Assets to one or more Subsidiaries, the terms of this Section 0 shall apply to such Subsidiaries in addition to Homology. Each Party further acknowledges that Homology may not be successful in completing, or may determine not to proceed, with the Legacy Asset Disposition. Notwithstanding the foregoing, Homology may not enter into any agreement with respect to the Legacy Asset Disposition that would result in a continuing obligation or liability without the prior written consent of Q32 (such consent shall not be unreasonably withheld, conditioned or delayed); provided, further, that Homology shall provide Q32 with a copy of any agreement with respect to an Legacy Asset Disposition that would be reasonably likely to result in a continuing obligation or liability of either Homology or Q32 on or after the Effective Time at least five Business Days prior to entry into such agreement.

(b) For the avoidance of doubt, any sale, transfer, license, assignment or other divestiture of Legacy Assets on or after the Closing Date shall be governed by the terms and conditions of the CVR Agreement.

5.7 Registration Statement; Proxy Statement.

(a) As promptly as practicable (but in any event, no later than twenty (20) Business Days) after the date of this Agreement, (i) Homology, in cooperation with Q32, shall prepare and file with the SEC a proxy statement relating to the Homology Stockholder Meeting to be held in connection with the Merger (together with any amendments thereof or supplements thereto, the “Proxy Statement”) and (ii) Homology, in cooperation with Q32, shall prepare and file with the SEC a registration statement on Form S-4 (the “Form S-4”), in which the Proxy Statement shall be included as a part (the Proxy Statement and the Form S-4, collectively, the “Registration Statement”), in connection with the registration under the Securities Act of the shares of Homology Common Stock to be issued by virtue of the Merger. Each of Homology and Q32 shall use their commercially reasonable efforts to respond promptly to any comments of the SEC or its staff and to cause the Registration Statement to become effective as promptly as practicable, and shall take all or any action required under any applicable federal, state, securities and other Laws in connection with the issuance of shares of Homology Common Stock pursuant to the Merger. Each of the Parties shall furnish all information concerning itself and their Affiliates, as applicable, to the other Parties as the other Parties may reasonably request in connection with such actions and the preparation of the Registration Statement and Proxy Statement.

(b) Homology covenants and agrees that the Registration Statement (and the letter to stockholders, notice of meeting and form of proxy included therewith) will not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary in order to make the statements made therein not misleading. Q32 covenants and agrees that the information supplied by or on behalf of Q32 and its Subsidiaries to Homology for inclusion in the Registration Statement (including the Q32 Financials) will not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary in order to make such information, in light of the circumstances under which they were made, not misleading. Notwithstanding the foregoing, Homology makes no covenant, representation or warranty with respect to statements made in the Registration Statement (and the letter to stockholders, notice of meeting and form of proxy included therewith), if any, based on information provided by Q32 or its Subsidiaries or any of their Representatives for inclusion therein. Q32 and its legal counsel shall be given reasonable opportunity to review and comment on the Registration Statement, including all amendments and supplements thereto, prior to the filing thereof with the SEC, and on the response to any comments on the SEC prior to the filing thereof with the SEC; provided, however, that the foregoing shall not apply to any amendment to the Registration Statement pertaining to a Homology Board Adverse Recommendation Change. Each of the Parties shall use commercially reasonable efforts to cause the Registration Statement to comply with the applicable rules and regulations promulgated by the SEC, to respond promptly to any comments of the SEC or its staff and to have the Registration Statement declared effective under the Securities Act as promptly as practicable after it is filed with the SEC.

 

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(c) Each of the Parties shall use commercially reasonable efforts to cause the Proxy Statement to be mailed to Homology’s stockholders as promptly as practicable after the Registration Statement is declared effective under the Securities Act. If Homology, Merger Sub or Q32 become aware of any event or information that, pursuant to the Securities Act or the Exchange Act, should be disclosed in an amendment or supplement to the Registration Statement or Proxy Statement, as the case may be, then such Party, as the case may be, shall promptly inform the other Parties thereof and shall cooperate with such other Parties in filing such amendment or supplement with the SEC and, if appropriate, in mailing such amendment or supplement to the Homology stockholders.

(d) Q32 shall reasonably cooperate with Homology and provide, and cause its Representatives to provide, Homology and its Representatives, with all true, correct and complete information regarding (i) Q32 and its Subsidiaries and (ii) the 2023 Plans that is, in each case, required by Law to be included in the Registration Statement or reasonably requested by Homology to be included in the Registration Statement. Q32 will use commercially reasonable efforts to cause Q32’s independent accounting firm to deliver any consent that Homology is required to file with the SEC with respect to the inclusion of the independent accounting firm’s opinion on the audited financial statements of Q32 in any filing of the Registration Statement with the SEC.

(e) As promptly as practicable following the date of this Agreement and no later than fifteen (15) Business Days after the date of this Agreement, Q32 shall deliver to Homology financial statements (including any related notes thereto) of Q32 and its consolidated Subsidiaries as of and for the fiscal years ended December 31, 2022 and 2021, with respect to which the PCAOB Auditor has substantially completed its audit work in accordance with the standards of the PCAOB, subject to providing the PCAOB Auditor’s report thereon for inclusion in the Registration Statement. As promptly as practicable following the date of this Agreement and no later than fifteen (15) Business Days after the date of this Agreement, Q32 shall deliver to Homology unaudited interim financial statements (including any related notes thereto) of Q32 and its consolidated Subsidiaries as of and for the nine months ended September 30, 2023 and 2022, with respect to which the PCAOB Auditor has substantially completed its review in accordance with the procedures specified by the PCAOB in AS 4105, Reviews of Interim Financial Information (the “interim review procedures”), for inclusion in the Registration Statement. All such financial statements included in the Registration Statement at the time of filing shall comply as to form in all material respects, shall be prepared in accordance with GAAP (as modified by the rules and regulations of the SEC) applied on a consistent basis throughout the periods involved, shall fairly present in all material respects the consolidated financial position at the date thereof and the results of its operations and cash flows as of and for the periods therein indicated and shall comply in all material respects with the applicable accounting requirements and with the rules and regulations of the SEC, the Exchange Act and the Securities Act applicable to a registrant, in effect as of the respective dates thereof.

5.8 Q32 Stockholder Written Consent.

(a) Promptly after the Registration Statement has been declared effective under the Securities Act, and in any event no later than two (2) Business Days thereafter, Q32 shall prepare, with the cooperation of Homology, and cause to be mailed to its stockholders an information statement, which shall include a copy of the Proxy Statement (the “Information Statement”), and the Q32 Stockholder Written Consent, in order to solicit the approval of Q32’s stockholders, including but not limited to Q32’s stockholders sufficient for the Required Q32 Stockholder Vote in lieu of a meeting pursuant to Section 228 of Delaware Law, for purposes of (i) adopting and approving this Agreement and the Contemplated Transactions, and (ii) acknowledging that the approval given thereby is irrevocable. Q32 shall use its reasonable best efforts to cause Q32’s stockholders sufficient for the Required Q32 Stockholder Vote to execute and deliver to Q32 the Q32 Stockholder Written Consent promptly following delivery thereof, and in any event no later than fifteen (15) days after the Registration Statement has been declared effective. Promptly following receipt of the duly executed Q32 Stockholder Written Consent, Q32 shall deliver a copy of the duly executed Q32 Stockholder Written Consent to Homology. Under no circumstances shall Q32 assert that any other approval or consent is necessary by its stockholders to approve this Agreement and the Contemplated Transactions.

 

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(b) Promptly following receipt of the Required Q32 Stockholder Vote, Q32 shall prepare and mail a notice to every stockholder of Q32 that did not execute the Q32 Stockholder Written Consent. Such notice shall (i) be a statement to the effect that the Q32 Board determined that the Merger is advisable in accordance with Section 251(b) of Delaware Law and in the best interests of the stockholders of Q32 and approved and adopted this Agreement, the Merger and the other Contemplated Transactions, and (ii) provide the stockholders of Q32 to whom it is sent with notice of the actions taken in the Q32 Stockholder Written Consent, including the adoption and approval of this Agreement, the Merger and the other Contemplated Transactions in accordance with Section 228(e) of Delaware Law and Q32’s Organizational Documents.

(c) Q32 agrees that: (i) the Q32 Board shall recommend that Q32’s stockholders vote to adopt and approve this Agreement and the Contemplated Transactions and shall use commercially reasonable efforts to solicit such approval within the time set forth in Section 5.8(a) (the recommendation of the Q32 Board that Q32’s stockholders vote to adopt and approve this Agreement being referred to as the “Q32 Board Recommendation”) and (ii) the Q32 Board Recommendation shall not be withdrawn or modified (and the Q32 Board shall not publicly propose to withdraw or modify the Q32 Board Recommendation) in a manner adverse to Homology, and no resolution by the Q32 Board or any committee thereof to withdraw or modify the Q32 Board Recommendation in a manner adverse to Homology or to adopt, approve or recommend (or publicly propose to adopt, approve or recommend) any Acquisition Proposal shall be adopted or proposed.

(d) Q32’s obligation to solicit the consent of its stockholders to sign the Q32 Stockholder Written Consent in accordance with Section 5.8(a) shall not be limited or otherwise affected by the commencement, disclosure, announcement or submission of any Superior Offer or other Acquisition Proposal.

5.9 Homology Stockholder Meeting.

(a) Homology shall take all action necessary under applicable Law to call, give notice of and hold a meeting of the holders of Homology Common Stock to consider and vote to approve this Agreement and the Contemplated Transactions, including the issuance of the shares of Homology Common Stock to the stockholders of Q32 pursuant to the terms of this Agreement and the Charter Amendment Proposal (collectively, the “Homology Stockholder Matters” and such meeting, the “Homology Stockholder Meeting”). The Homology Stockholder Meeting shall be held as promptly as practicable after the Registration Statement is declared effective under the Securities Act, and in any event no later than forty-five (45) days after the effective date of the Registration Statement. Homology shall take reasonable measures to ensure that all proxies solicited in connection with the Homology Stockholder Meeting are solicited in compliance with all applicable Law. Notwithstanding anything to the contrary contained herein, if on the date of the Homology Stockholder Meeting, or a date preceding the date on which the Homology Stockholder Meeting is scheduled, Homology reasonably believes that (i) it will not receive proxies sufficient to obtain the Required Homology Stockholder Vote, whether or not a quorum would be present or (ii) it will not have sufficient shares of Homology Common Stock represented (whether in person or by proxy) to constitute a quorum necessary to conduct the business of the Homology Stockholder Meeting, Homology may postpone or adjourn, or make one or more successive postponements or adjournments of, the Homology Stockholder Meeting as long as the date of the Homology Stockholder Meeting is not postponed or adjourned more than an aggregate of thirty (30) calendar days in connection with any postponements or adjournments.

(b) Homology agrees that, subject to Section 5.9(c): (i) the Homology Board shall recommend that the holders of Homology Common Stock vote to approve the Homology Stockholder Matters and shall use commercially reasonable efforts to solicit such approval within the timeframe set forth in Section 5.9(a) above, (ii) the Proxy Statement shall include a statement to the effect that the Homology Board recommends that Homology’s stockholders vote to approve the Homology Stockholder Matters (the recommendation of the Homology Board being referred to as the “Homology Board Recommendation”) and (iii) the Homology Board Recommendation shall not be withheld, amended, withdrawn or modified (and the Homology Board shall not publicly propose to withhold, amend, withdraw or modify the Homology Board Recommendation) in a manner

 

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adverse to Q32, and no resolution by the Homology Board or any committee thereof to withdraw or modify the Homology Board Recommendation in a manner adverse to Q32 or to adopt, approve or recommend (or publicly propose to adopt, approve or recommend) any Acquisition Proposal shall be adopted or proposed (the actions set forth in the foregoing clause (iii), collectively, a “Homology Board Adverse Recommendation Change”).

(c) Notwithstanding anything to the contrary contained in Section 5.9(b), and subject to compliance with Section 5.4 and Section 5.9, at any time prior to the approval of Homology Stockholder Matters by the Required Homology Stockholder Vote, Homology receives a bona fide written Superior Offer, the Homology Board may make a Homology Board Adverse Recommendation Change if, but only if, in the receipt of and on account of such Superior Offer, (i) the Homology Board determines in good faith, after consultation with its outside legal counsel, that the failure to make a Homology Board Adverse Recommendation Change would reasonably be expected to be inconsistent with its fiduciary duties under applicable Law, (ii) Homology has, and has caused its financial advisors and outside legal counsel to, during the Notice Period, negotiate with Q32 in good faith to make such adjustments to the terms and conditions of this Agreement so that such Acquisition Proposal ceases to constitute a Superior Offer and (iii) if after Q32 shall have delivered to Homology a written offer to alter the terms or conditions of this Agreement during the Notice Period (or if Q32 declines to do so), the Homology Board shall have determined in good faith, after consultation with its outside legal counsel, that the failure to withhold, amend, withdraw or modify the Homology Board Recommendation would reasonably be expected to be inconsistent with its fiduciary duties under applicable Law (after taking into account such alterations of the terms and conditions of this Agreement, if any); provided that (x) Q32 receives written notice from Homology confirming that the Homology Board has determined to change its recommendation during the Notice Period, which notice shall include a description in reasonable detail of the reasons for such Homology Board Adverse Recommendation Change, and written copies of any relevant proposed transaction agreements with any party making a potential Superior Offer, (y) during any Notice Period, Q32 shall be entitled to deliver to Homology one or more counterproposals to such Acquisition Proposal and Homology will, and cause its Representatives to, negotiate with Q32 in good faith (to the extent Q32 desires to negotiate) to make such adjustments in the terms and conditions of this Agreement so that the applicable Acquisition Proposal ceases to constitute a Superior Offer and (z) in the event of any material amendment to any Superior Offer (including any revision in price or percentage of the combined company that Homology’s stockholders would receive as a result of such potential Superior Offer), Homology shall be required to provide Q32 with notice of such material amendment and the Notice Period shall be extended, if applicable, to ensure that at least two (2) Business Days remain in the Notice Period following such notification during which the parties shall comply again with the requirements of this Section 5.9(c) and the Homology Board shall not make a Homology Board Adverse Recommendation Change prior to the end of such Notice Period as so extended (it being understood that there may be multiple extensions).

(d) Homology’s obligation to call, give notice of and hold the Homology Stockholder Meeting in accordance with Section 5.9(a) shall not be limited or otherwise affected by the commencement, disclosure, announcement or submission of any Superior Offer or Acquisition Proposal, or by any withdrawal or modification of the Homology Board Recommendation.

(e) Nothing contained in this Agreement shall prohibit Homology or the Homology Board from complying with Rules 14d-9 and 14e-2(a) promulgated under the Exchange Act; provided, however, that any disclosure made by Homology or the Homology Board pursuant to Rules 14d-9 and 14e-2(a) shall be limited to a statement that Homology is unable to take a position with respect to the bidder’s tender offer unless the Homology Board determines in good faith, after consultation with its outside legal counsel, that such statement would result in a breach of its fiduciary duties under applicable Law.

5.10 Efforts; Regulatory Approvals.

(a) The Parties shall use commercially reasonable efforts to consummate the Contemplated Transactions. Without limiting the generality of the foregoing, each Party: (i) shall make all filings and other submissions (if any) and give all notices (if any) required to be made and given by such Party in connection with the

 

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Contemplated Transactions, (ii) shall use commercially reasonable efforts to obtain each Consent (if any) reasonably required to be obtained (pursuant to any applicable Law or Contract, or otherwise) by such Party in connection with the Contemplated Transactions or for such Contract to remain in full force and effect, (iii) shall use commercially reasonable efforts to lift any injunction prohibiting, or any other legal bar to, the Contemplated Transactions and (iv) shall use commercially reasonable efforts to satisfy the conditions precedent to the consummation of this Agreement.

(b) Notwithstanding the generality of the foregoing, each Party shall use commercially reasonable efforts to file or otherwise submit, as soon as practicable after the date of this Agreement, all applications, notices, reports and other documents reasonably required to be filed by such Party with or otherwise submitted by such Party to any Governmental Authority with respect to the Contemplated Transactions, and to submit promptly any additional information requested by any such Governmental Authority.

5.11 Disclosures. Without limiting any Party’s obligations under the Confidentiality Agreement, no Party shall, and no Party shall permit any of its Subsidiaries or any of its Representative to, issue any press release or make any disclosure (to any customers or employees of such Party, to the public or otherwise) regarding the Contemplated Transactions unless: (a) the other Party shall have approved such press release or disclosure in writing, such approval not to be unreasonably conditioned, withheld or delayed; or (b) such Party shall have determined in good faith, upon the advice of outside legal counsel, that such disclosure is required by applicable Law and, to the extent practicable, before such press release or disclosure is issued or made, such Party advises the other Party of, and consults with the other Party regarding, the text of such press release or disclosure; provided, however, that each of Q32 and Homology may make any statement in response to questions by the press, analysts, investors or those attending industry conferences or financial analyst conference calls, so long as any such statements are consistent with previous press releases, public disclosures or public statements made by Q32 and Homology in compliance with this Section 5.11. Notwithstanding the foregoing, a Party need not consult with any other Parties in connection with such portion of any press release, public statement or filing to be issued or made pursuant to Section 5.9(d) or with an Acquisition Proposal, or Homology Board Adverse Recommendation Change with respect to Homology only pursuant to Section 5.9(e).

5.12 Homology Options. Prior to the Closing, the Homology Board shall have adopted appropriate resolutions and taken all other actions necessary and appropriate to provide (a) each outstanding Homology Option that is not a Homology ITM Option will be cancelled for no consideration and (b) that the vesting and exercisability of each unexpired, unexercised and unvested Homology ITM Option shall be accelerated in full, in each case, effective as of immediately prior to the Effective Time, contingent on the occurrence of the Closing.

5.13 Homology Restricted Stock Unit Awards. Prior to the Closing, the Homology Board shall have adopted appropriate resolutions and taken all other actions necessary and appropriate to provide that (a) the vesting of each outstanding and unvested Homology Restricted Stock Unit Award shall be accelerated in full effective as of immediately prior to the Effective Time, contingent on the occurrence of the Closing and (b) for each outstanding and unsettled Homology Restricted Stock Unit Award, the holder thereof shall receive, immediately prior to the Effective Time, a number of shares of Homology Common Stock equal to the number of vested and unsettled shares of Homology Common Stock underlying such Homology Restricted Stock Unit Award. Notwithstanding anything herein to the contrary, the Tax withholding obligations for each holder receiving shares of Homology Common Stock in accordance with the preceding sentence shall be satisfied by Homology withholding from issuance that number of shares of Homology Common Stock calculated by multiplying the maximum statutory withholding rate for such holder in connection with such issuance by the number of shares of Homology Common Stock to be issued in accordance with the preceding sentence, and rounding up to the nearest whole share and remitting such withholding in cash to the appropriate taxing authorities (the amount of such cash, the “RSU Withholding Amount”).

5.14 Homology ESPP. As soon as reasonably practicable following the date of this Agreement, the Homology Board shall adopt appropriate resolutions to provide that (a) no offering periods or purchase periods

 

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shall be commenced following or in addition to the offering period underway as of the date hereof under the Homology ESPP (the “Current Offering Period”), (b) no payroll deductions or other contributions shall be made or effected after the Current Offering Period with respect to the Homology ESPP, and (c) each Homology ESPP participant’s accumulated contributions under the Homology ESPP shall be returned to the participant in accordance with the terms of the Homology ESPP.

5.15 Indemnification of Officers and Directors.

(a) From the Effective Time through the sixth anniversary of the date on which the Effective Time occurs (or such period in which a D&O Indemnified Party (defined below) is asserting a claim for indemnification or other protections pursuant to this Section 5.15 to the extent arising prior to the end of such six-year period), each of Homology and the Surviving Corporation shall indemnify and hold harmless each person who is now, or has been at any time prior to the date hereof, or who becomes prior to the Effective Time, a director or officer of Homology or Q32, respectively (the “D&O Indemnified Parties”), against all claims, losses, liabilities, settlements, damages, judgments, fines and penalties and reasonable fees, costs and expenses, including attorneys’ fees and disbursements (collectively, “Costs”), incurred in connection with any claim, action, suit, proceeding or investigation, whether civil, criminal, administrative or investigative, formal or informal, arising out of or pertaining to the fact that the D&O Indemnified Party is or was a director or officer of Homology or of Q32, whether asserted or claimed prior to, at or after the Effective Time (including in connection with this Agreement or the Contemplated Transactions), in each case, to the fullest extent permitted under Delaware Law (including as it may be amended after the date of this Agreement to increase the extent to which a corporation may provide indemnification). Each D&O Indemnified Party will be entitled to advancement of fees, costs and expenses incurred in the defense of any such claim, action, suit, proceeding or investigation from each of Homology and the Surviving Corporation, jointly and severally, upon receipt by Homology or the Surviving Corporation from the D&O Indemnified Party of a request therefor; provided that any such person to whom fees, costs or expenses are advanced provides an undertaking to Homology, to the extent then required by Delaware Law, to repay such advances if it is ultimately determined that such person is not entitled to indemnification. Homology and the Surviving Corporation shall each cooperate with the D&O Indemnified Party in the defense of any actual or threatened claim, action, suit, proceeding or investigation.

(b) The provisions of Homology’s Organizational Documents with respect to indemnification, advancement of expenses and exculpation of present and former directors and officers of Homology that are presently set forth in Homology’s Organizational Documents shall not be amended, modified or repealed for a period of six years from the Effective Time in a manner that would adversely affect the rights thereunder of individuals who, at or prior to the Effective Time, were officers or directors of Homology, unless such modification is required by applicable Law. The Surviving Corporation’s Organizational Documents shall contain, and Homology shall cause the certificate of incorporation of the Surviving Corporation to so contain, provisions no less favorable with respect to indemnification, advancement of fees, costs and expenses and exculpation of future, present and former directors and officers as those presently set forth in Homology’s and Q32’s Organizational Documents, respectively.

(c) From and after the Effective Time, (i) the Surviving Corporation shall fulfill and honor in all respects the obligations of Q32 to its D&O Indemnified Parties as of immediately prior to the Effective Time pursuant to any indemnification, exculpation and advancement provisions under Q32’s Organizational Documents and pursuant to any indemnification agreements between Q32 and such D&O Indemnified Parties, with respect to any claim, action, suit, proceeding or investigation, whether civil, criminal, administrative or investigative, formal or informal, arising out of matters occurring at or prior to the Effective Time, whether asserted or claimed prior to, at or after the Effective Time (including in connection with this Agreement or the Contemplated Transactions), and (ii) Homology shall fulfill and honor in all respects the obligations of Homology to its D&O Indemnified Parties as of immediately prior to the Closing pursuant to any indemnification provisions under Homology’s Organizational Documents and pursuant to any indemnification agreements between Homology and such D&O Indemnified Parties, with respect to claims arising out of matters occurring at or prior to the Effective Time.

 

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(d) From and after the Effective Time, Homology and the Surviving Corporation shall maintain directors’ and officers’ liability insurance policies, with an effective date as of the Closing Date, on commercially available terms and conditions and with coverage limits customary for U.S. public companies similarly situated to Homology. In addition, Homology shall purchase, prior to the Effective Time, a six-year prepaid non-cancellable extension of directors’ and officers’ liability coverage of Homology’s existing directors’ and officers’ insurance policies for a claims reporting or discovery period of at least six years from and after the Effective Time with respect to any claim related to any period of time at or prior to the Effective Time “Homology D&O Tail Coverage” with the same or substantially the same terms, conditions, retentions and limits of liability as the coverage provided under Homology’s existing policies as of the date of this Agreement with respect to any actual or alleged error, misstatement, misleading statement, act, omission, neglect, breach of duty or any matter claimed against a director or officer of Homology by reason of him or her serving in such capacity that existed or occurred at or prior to the Effective Time (including in connection with this Agreement or the Contemplated Transactions or in connection with Homology’s initial public offering of shares of Homology Common Stock).

(e) From and after the Effective Time, each of Homology and the Surviving Corporation, jointly and severally, shall pay all expenses, including reasonable fees, costs and expenses, including attorneys’ fees and disbursements in advance, that are incurred by the persons referred to in this Section 5.15 in connection with their enforcement of the rights provided to such persons in this Section 5.15.

(f) The provisions of this Section 5.15 are intended to be in addition to the rights otherwise available to the current and former officers and directors of Homology and Q32 by Law, charter, statute, bylaw or agreement, and shall operate for the benefit of, and shall be enforceable by, each of the D&O Indemnified Parties, their heirs and their Representatives.

(g) In the event Homology or the Surviving Corporation or any of their respective successors or assigns (i) consolidates with or merges into any other Person and shall not be the continuing or surviving corporation or entity of such consolidation or merger or (ii) transfers all or substantially all of its properties and assets to any Person, then, and in each such case, proper provision shall be made so that the successors and assigns of Homology or the Surviving Corporation, as the case may be, shall succeed to the obligations set forth in this Section 5.15. Homology shall cause the Surviving Corporation to perform all of the obligations of the Surviving Corporation under this Section 5.15.

5.16 Tax Matters.

(a) All transfer, documentary, sales, use, stamp, registration, excise, recording, registration value added and other such similar Taxes and fees (including any penalties and interest) that become payable by Q32 or Homology in connection with or by reason of the execution of this Agreement and the transactions contemplated hereby (collectively, “Transfer Taxes”) shall be borne and paid by Homology. The Person required by applicable law shall timely file any Tax Return or other document with respect to such Transfer Taxes.

(b) At the Closing, Q32 shall deliver to Homology a certificate pursuant to Treasury Regulations Sections 1.1445-2(c) and 1.897-2(h), together with a form of notice to the IRS in accordance with the requirements of Treasury Regulations Section 1.897-2(h), in each case, in form and substance reasonably acceptable to Homology; provided, however, that Homology’s only remedy for Q32’s failure to provide such form or certificate will be to withhold from the payments to be made pursuant to this Agreement any required withholding Tax under Section 1445 of the Code, and Q32’s failure to provide any such form or certificate will not be deemed to be a failure of the conditions set forth in Article VI to have been met.

(c) The parties intend that, for United States federal income tax purposes, the Merger will qualify for the Intended Tax Treatment. The Merger shall be reported by the parties for all Tax purposes in accordance with the foregoing, unless otherwise required by a Governmental Authority as a result of a “determination” within the meaning of Section 1313(a) of the Code. The parties shall cooperate with each other and their respective counsel

 

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to document and support the Tax treatment of the Merger as qualifying for the Intended Tax Treatment, including by taking the actions described on Section 5.16(c) of the Q32 Disclosure Schedule.

5.17 Listing. At or prior to the Effective Time, Homology shall use commercially reasonable efforts to (a) maintain a listing on Nasdaq until the Effective Time and, to the extent required by the rules and regulations of Nasdaq, obtain approval of the listing of the combined company on Nasdaq; (b) to the extent required by the rules and regulations of Nasdaq, prepare and submit to Nasdaq a notification form for the listing of the shares of Homology Common Stock to be issued in connection with the Contemplated Transactions and to cause such shares to be approved for listing; (c) prepare and timely submit to Nasdaq a notification form of the Nasdaq Reverse Split and to submit a copy of the amendment to Homology’s certificate of incorporation to effect the Nasdaq Reverse Split and other amendments contemplated by Section 2.4 certified by the Secretary of State of the State of Delaware, to Nasdaq on or before the Closing Date; and (d) to the extent required by Nasdaq Marketplace Rule 5110, assist Q32 in preparing and filing an initial listing application for the Homology Common Stock on Nasdaq (the “Nasdaq Listing Application”). The Party not filing the Nasdaq Listing Application will cooperate with the other Party as reasonably requested by such filing Party with respect to the Nasdaq Listing Application and promptly furnish to such filing Party all information concerning itself and its stockholders that may be required or reasonably requested in connection with any action contemplated by this Section 5.17.

5.18 Legends. Homology shall be entitled to place appropriate legends on the book entries and/or certificates evidencing any shares of Homology Common Stock to be received in the Merger by equityholders of Q32 who may be considered “affiliates” of Homology for purposes of Rules 144 and 145 under the Securities Act reflecting the restrictions set forth in Rules 144 and 145 and to issue appropriate stop transfer instructions to the transfer agent for Homology Common Stock.

5.19 Officers and Directors.

(a) Directors and Officers of Homology.

(i) Homology shall cause, effective as of the Effective Time, the Homology Board to consist of nine (9) individuals, which shall consist of (A) seven (7) members selected by the Q32 Board (each, a “Q32 Designee”) and (B) two (2) members selected by the Homology Board as set forth on Section 5.19(a)(i) of the Homology Disclosure Schedule (each, a “Homology Designee”). Q32 shall deliver a notice to Homology identifying each of the Q32 Designees at least three (3) Business Days prior to the Closing Date. If any Q32 Designee or Homology Designee is unable or unwilling to serve as director of Homology, the Party appointing such Person shall designate a successor.

(ii) Homology shall cause the directors and officers of Homology listed on Section 5.19(a)(ii) of the Homology Disclosure Schedule to sign written resignations in forms reasonably satisfactory to Q32, dated on or before the Closing Date and effective as of the Effective Time.

(iii) Immediately following the Effective Time, Homology shall take all necessary action to appoint the officers of Q32 to become the equivalent officers of Homology until the earlier of their resignation or removal or until their respective successors are duly elected or appointed and qualified, as the case may be.

(b) Directors and Officers of the Surviving Corporation.

(i) The Parties shall take all actions necessary (A) so that from and after the Effective Time, the Surviving Corporation’s board of directors shall be constituted with those members as set forth on Section 5.19(b) of the Homology Disclosure Schedule and (B) to secure the resignations of the existing members of the committees of the Surviving Corporation, if any.

(ii) The Parties shall take all actions necessary so that the officers of Q32 immediately prior to the Effective Time shall, from and after the Effective Time, be the officers of the Surviving Corporation, until the earlier of their resignation or removal or until their respective successors are duly elected or appointed and qualified, as the case may be.

 

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(iii) On the Closing Date, the Surviving Corporation shall enter into customary indemnification agreements reasonably satisfactory to Q32 with each individual to be appointed to, or serving on, the board of directors of the Surviving Corporation upon the Closing, which indemnification agreements shall continue to be effective following the Closing.

5.20 Termination of Certain Agreements and Rights. Q32 shall cause any stockholder agreements, voting agreements, registration rights agreements, co-sale agreements and any other similar Contracts between Q32 and any holders of Q32 Capital Stock, including any such Contract granting any Person investor rights, rights of first refusal, registration rights or director registration rights to be terminated immediately prior to the Effective Time, without any liability being imposed on the part of Homology or the Surviving Corporation.

5.21 Section 16 Matters. Prior to the Effective Time, Homology shall take all such steps as may be required to cause any acquisitions of Homology Common Stock and any options to purchase Homology Common Stock in connection with the Contemplated Transactions, by each individual who is reasonably expected to become subject to the reporting requirements of Section 16(a) of the Exchange Act with respect to Homology, to be exempt under Rule 16b-3 promulgated under the Exchange Act.

5.22 Allocation Certificate. Q32 will prepare and deliver to Homology at least two (2) Business Days prior to the Closing Date a certificate signed by an executive officer of Q32 in a form reasonably acceptable to Homology setting forth (as of immediately prior to the Effective Time) (a) each holder of Q32 Capital Stock, (b) such holder’s name and address, (c) the number and type of Q32 Capital Stock held as of the Closing Date for each such holder and (d) the number of shares of Homology Common Stock to be issued to such holder pursuant to this Agreement in respect of the Q32 Capital Stock held by such holder as of immediately prior to the Effective Time, and (e) each investor in the Concurrent Financing, the total investment to be made by such investor in the Concurrent Financing, the percentage of the Concurrent Financing Proceeds represented by such stockholder’s investment in the Concurrent Financing, and the number of shares of Homology Common Stock to be issued to such holder pursuant to this Agreement (the “Allocation Certificate”). For the avoidance of doubt, the Allocation Certificate shall be prepared in good faith, in accordance with the Organizational Documents of Q32 and contracts applicable to Q32 Capital Stock, Q32 Options and Q32 Warrants], and shall show each holder’s percentage ownership interest in Q32 on a fully diluted basis.

5.23 Nasdaq Reverse Split. Homology shall submit to Homology’s stockholders at the Homology Stockholder Meeting the Reverse Stock Split Proposal, and the Parties shall take such other actions as shall be reasonably necessary to effectuate the Nasdaq Reverse Split.

5.24 Obligations of Merger Sub. Homology will take all action necessary to cause Merger Sub to perform its obligations under this Agreement and to consummate the Merger on the terms and conditions set forth in this Agreement.

5.25 Takeover Statutes. If any takeover statute is or may become applicable to the Contemplated Transactions, each of Q32, the Q32 Board, Homology and the Homology Board, as applicable, shall grant such approvals and take such actions as are necessary, to the extent permitted by Law, so that the Contemplated Transactions may be consummated as promptly as practicable on the terms contemplated by this Agreement and otherwise act to eliminate or minimize the effects of such statute or regulation on the Contemplated Transactions.

5.26 Stockholder Litigation. Each Party shall keep the other Party reasonably informed regarding any stockholder litigation against Homology or any of its directors relating to this Agreement or the Contemplated Transactions (“Transaction Litigation”). Prior to the Closing, Homology shall have the right to control the defense and settlement of any Transaction Litigation, but shall reasonably consult with Q32 and consider any advice from Q32 and its Representatives with respect to Transaction Litigation. Homology shall promptly advise Q32 of the initiation of, and shall keep Q32 reasonably apprised of any material developments in connection with, any such Transaction Litigation.

 

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5.27 Concurrent Financing.

(a) Subject to the terms and conditions of this Agreement, Q32 shall use commercially reasonable efforts to obtain the Concurrent Financing on the terms and conditions described in the Subscription Agreement and satisfy the conditions to the Concurrent Financing as described in the Subscription Agreement and shall not permit any termination, amendment or modification to be made to, or any waiver of any provision under, or any replacement of, the Subscription Agreement if such termination, amendment, modification, waiver or replacement (i) reduces the aggregate amount of the Concurrent Financing or (ii) imposes new or additional conditions or otherwise expands, amends or modifies any of the conditions to the receipt of the Concurrent Financing, or otherwise expands, amends or modifies any other provision of the Subscription Agreement, in a manner that would reasonably be expected to (x) delay or prevent the funding of the Concurrent Financing (or satisfaction of the conditions to the Concurrent Financing) at or substantially simultaneously with the Closing or (y) adversely impact the ability of Q32 to enforce its rights against other parties to the Subscription Agreement. Q32 shall promptly deliver to Homology copies of any such termination, amendment, modification, waiver or replacement.

(b) Q32 shall use commercially reasonable efforts (i) to maintain in effect the Subscription Agreement, (ii) to enforce its rights under the Subscription Agreement and (iii) to comply with its obligations under the Subscription Agreement.

(c) Q32 shall give Homology prompt notice (i) of any breach or default by any party to the Subscription Agreement or definitive agreements related to the Concurrent Financing of which Q32 becomes aware, (ii) of the receipt of any written notice or other written communication from any Purchaser with respect to any (x) actual breach, default, termination or repudiation by any party to the Subscription Agreement or definitive agreements related to the Concurrent Financing of any provisions of the Subscription Agreement or definitive agreements related to the Concurrent Financing or (y) material dispute or disagreement relating to the Concurrent Financing with respect to the obligation to fund the Concurrent Financing at or substantially simultaneously with the Closing, and (iii) if at any time for any reason Q32 believes in good faith that it will not be able to obtain all or any portion of the Concurrent Financing on the terms and conditions, in the manner or from the sources contemplated by the Subscription Agreement or definitive agreements related to the Concurrent Financing. Q32 shall promptly provide information reasonably requested by Homology relating to the circumstances referred to in clauses (i), (ii) or (iii) of the immediately preceding sentence.

5.28 Homology Equity Plans.

(a) Prior to the effectiveness of the Form S-4, Homology will use commercially reasonable efforts to cause the Homology Board to adopt the 2024 Equity Incentive Plan, subject to the Closing and the approval of the stockholders of Homology prior to the Effective Time and effective as of the Effective Time, and at Q32’s expense, will include provisions in the Proxy Statement for the stockholders of Homology to approve the 2024 Equity Incentive Plan. Subject to the approval of the 2024 Equity Incentive Plan by the stockholders of Homology prior to the Effective Time, Homology shall file with the SEC, promptly after the Effective Time and at Q32’s expense, a registration statement on Form S-8 (or any successor form), if available for use by Homology, relating to the shares of Homology Common Stock issuable with respect to the 2024 Equity Incentive Plan.

(b) Prior to the effectiveness of the Form S-4, Homology will use commercially reasonable efforts to cause the Homology Board to adopt the 2024 ESPP, subject to the Closing and the approval of the stockholders of Homology prior to the Effective Time and effective as of the Effective Time, and at Q32’s expense, will include provisions in the Proxy Statement for the stockholders of Homology to approve the 2024 ESPP. Subject to the approval of the 2024 ESPP by the stockholders of Homology prior to the Effective Time, Homology shall file with the SEC, promptly after the Effective Time and at Q32’s expense, a registration statement on Form S-8 (or any successor form), if available for use by Homology, relating to the shares of Homology Common Stock issuable with respect to the 2024 ESPP.

 

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(c) For the avoidance of doubt, approval of the 2024 Plans by the stockholders of Homology shall not be a condition to Closing.

5.29 Homology 401(k) Plan. Unless otherwise requested by Q32 in writing at least ten (10) Business Days prior to the Closing Date, the Homology Board or an authorized committee thereof shall take (or cause to be taken) all actions to adopt such resolutions as may be necessary or appropriate to terminate, effective no later than the day prior to the Closing Date but subject to the Closing, any Homology Employee Plan that contains a cash or deferred arrangement intended to qualify under Section 401(k) of the Code (a “Homology 401(k) Plan”). If Homology is required to terminate any Homology 401(k) Plan, then Homology shall provide to Q32 prior to the Closing Date written evidence of the adoption by the Homology Board or an authorized committee thereof of resolutions authorizing the termination of such Homology 401(k) Plan (the form and substance of which shall be subject to the reasonable prior review and approval of Q32, not to be unreasonably withheld, conditioned or delayed).

ARTICLE VI

CONDITIONS TO CONSUMMATION OF THE MERGER

6.1 Conditions Precedent to Obligations of Each Party. The obligations of each Party to effect the Merger and otherwise consummate the Contemplated Transactions are subject to the satisfaction or, to the extent permitted by applicable law, the written waiver by each of the Parties, at or prior to the Closing, of each of the following conditions:

(a) No temporary restraining order, preliminary or permanent injunction or other Order preventing the consummation of the Contemplated Transactions shall have been issued by any court of competent jurisdiction or other Governmental Authority of competent jurisdiction and remain in effect and there shall not be any Law which has the effect of making the consummation of the Contemplated Transactions illegal.

(b) Homology shall have obtained the Required Homology Stockholder Vote, and Q32 shall have obtained the Required Q32 Stockholder Vote.

(c) The approval of the listing of the additional shares of Homology Common Stock on Nasdaq shall have been obtained and the shares of Homology Common Stock to be issued in the Merger pursuant to this Agreement shall have been approved for listing (subject to official notice of issuance) on Nasdaq.

(d) The Subscription Agreement shall be in full force and effect and cash proceeds of not less than the Concurrent Investment Amount shall have been received by Homology, or will be received by Homology substantially simultaneously with the Closing, in connection with the consummation of the transactions contemplated by the Subscription Agreement.

(e) The Homology Lock-Up Agreements and Q32 Lock-Up Agreements will continue to be in full force and effect as of immediately following the Effective Time.

(f) The Registration Statement shall have become effective in accordance with the provisions of the Securities Act, and shall not be subject to any stop order or proceeding seeking a stop order with respect to such Registration Statement that has not been withdrawn.

(g) Q32 shall have effected the Q32 Preferred Stock Conversion.

 

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6.2 Conditions Precedent to Obligations of Q32. The obligations of Q32 to effect the Merger and otherwise consummate the Contemplated Transactions are subject to the satisfaction or, to the extent permitted by applicable law, the written waiver by Q32, at or prior to the Closing, of each of the following conditions:

(a) Each of the Homology Fundamental Representations shall have been true and correct in all respects as of the date of this Agreement and shall be true and correct in all material respects on and as of the Closing Date with the same force and effect as if made on and as of such date (except to the extent such representations and warranties are specifically made as of a particular date, in which case such representations and warranties shall be true and correct as of such date). The Homology Capitalization Representations shall have been true and correct in all respects as of the date of this Agreement and shall be true and correct on and as of the Closing Date with the same force and effect as if made on and as of such date, except, in each case, (x) for such inaccuracies which are de minimis, individually or in the aggregate or (y) for those representations and warranties which address matters only as of a particular date (which representations and warranties shall have been true and correct, subject to the qualifications as set forth in the preceding clause (x), as of such particular date). The representations and warranties of Homology and Merger Sub contained in this Agreement (other than the Homology Fundamental Representations and the Homology Capitalization Representations) shall have been true and correct in all respects as of the date of this Agreement and shall be true and correct on and as of the Closing Date with the same force and effect as if made on the Closing Date except (i) in each case, or in the aggregate, where the failure to be true and correct would not reasonably be expected to have a Homology Material Adverse Effect (without giving effect to any references therein to any Homology Material Adverse Effect or other materiality qualifications), (ii) where the failure to be true and correct as of the Closing Date is the result of (a) a Legacy Asset Disposition or (b) abandonment of or failure to file, prosecute or maintain any Abandoned Homology Legacy IP Rights (provided that this clause (ii) shall not cover any liability related to Legacy IP Rights (e.g., liability for infringement) that remains with the Company following Closing or (iii) for those representations and warranties which address matters only as of a particular date (which representations shall have been true and correct, subject to the qualifications as set forth in the preceding clause (i) and (ii), as of such particular date) (it being understood that, for purposes of determining the accuracy of such representations and warranties, any update of or modification to the Homology Disclosure Schedule made or purported to have been made after the date of this Agreement shall be disregarded).

(b) Homology and Merger Sub shall have performed or complied in all material respects with all covenants and agreements required to be performed or complied with by them under this Agreement at or prior to the Closing Date.

(c) A Homology Material Adverse Effect shall not have occurred since the date of this Agreement and be continuing.

(d) Homology shall have delivered to Q32 a certificate (the “Homology Closing Certificate”), dated the Closing Date and signed by an executive officer of Homology, certifying to the effect that the conditions set forth in Sections 6.2(a) and 6.2(b) have been satisfied.

6.3 Conditions Precedent to Obligations of Homology. The obligations of Homology and Merger Sub to effect the Merger and otherwise consummate the Contemplated Transactions are subject to the satisfaction or, to the extent permitted by applicable law, the written waiver by Homology, at or prior to the Closing, of each of the following conditions:

(a) Each of the Q32 Fundamental Representations shall have been true and correct in all respects as of the date of this Agreement and shall be true and correct in all material respects on and as of the Closing Date with the same force and effect as if made on and as of such date (except to the extent such representations and warranties are specifically made as of a particular date, in which case such representations and warranties shall be true and correct as of such date). The Q32 Capitalization Representations shall have been true and correct in all respects as of the date of this Agreement and shall be true and correct on and as of the Closing Date with the

 

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same force and effect as if made on and as of such date, except, in each case, (x) for such inaccuracies which are de minimis, individually or in the aggregate or (y) for those representations and warranties which address matters only as of a particular date (which representations and warranties shall have been true and correct, subject to the qualifications as set forth in the preceding clause (x), as of such particular date). The representations and warranties of Q32 contained in this Agreement (other than the Q32 Fundamental Representations and the Q32 Capitalization Representations) shall have been true and correct in all respects as of the date of this Agreement and shall be true and correct on and as of the Closing Date with the same force and effect as if made on the Closing Date except (i) in each case, or in the aggregate, where the failure to be so true and correct would not reasonably be expected to have a Q32 Material Adverse Effect (without giving effect to any references therein to any Q32 Material Adverse Effect or other materiality qualifications) or (ii) for those representations and warranties which address matters only as of a particular date (which representations shall have been true and correct, subject to the qualifications as set forth in the preceding clause (a), as of such particular date) (it being understood that, for purposes of determining the accuracy of such representations and warranties, any update of or modification to the Q32 Disclosure Schedule made or purported to have been made after the date of this Agreement shall be disregarded).

(b) Q32 shall have performed and complied in all material respects with all covenants and agreements required to be performed or complied with by it under this Agreement at or prior to the Closing Date.

(c) A Q32 Material Adverse Effect shall not have occurred since the date of this Agreement and be continuing.

(d) Q32 shall have delivered to Homology a certificate (the “Q32 Closing Certificate”), dated the Closing Date and signed by an executive officer of Q32, certifying to the effect that (i) the conditions set forth in Sections 6.3(a), 6.3(b) and 6.3(c) have been satisfied and (ii) the information set forth in the Allocation Certificate delivered by Q32 in accordance with Section 5.22 is true and accurate in all respects as of the Closing Date.

6.4 Frustration of Closing Conditions. Neither Homology nor Merger Sub may rely on the failure of any conditions set forth in Sections 6.1 or 6.3 to be satisfied if the primary cause of such failure was the failure of Homology or Merger Sub to perform any of its obligations under this Agreement. Q32 may not rely on the failure of any conditions set forth in Sections 6.1 or 6.2 to be satisfied if the primary cause of such failure was the failure of Q32 to perform any of its obligations under this Agreement.

ARTICLE VII

CLOSING DELIVERIES

7.1 Closing Deliveries of Q32. The obligations of Homology and Merger Sub to effect the Merger and otherwise consummate the Contemplated Transactions are subject to Homology receiving the following documents, each of which shall be in full force and effect, or the written waiver by Homology of delivery:

(a) the Q32 Stockholder Written Consents;

(b) the Allocation Certificate; and

(c) the Q32 Closing Certificate.

7.2 Closing Deliveries of Homology. The obligations of Q32 to effect the Merger and otherwise consummate the Contemplated Transactions are subject to Q32 receiving the following documents, each of which shall be in full force and effect, or the written waiver by Q32 of delivery:

(a) the Homology Net Cash Schedule;

(b) the Homology Closing Certificate;

 

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(c) subject to Section 2.5, the executed CVR Agreement; and

(d) written resignations in forms satisfactory to Q32, dated as of the Closing Date and effective as of the Closing executed by the officers and directors of Homology who are not to continue as officers or directors of Homology pursuant to Section 5.19 hereof.

ARTICLE VIII

TERMINATION

8.1 Termination. This Agreement may be terminated, and the Merger and the Contemplated Transactions may be abandoned at any time prior to the Effective Time, whether before or (subject to the terms hereof) after approval of the Homology Stockholder Matters by Homology’s stockholders, unless otherwise specified below:

(a) by mutual written consent of Homology and Q32;

(b) by either Homology and Q32 if the Merger shall not have been consummated by May 16, 2024 (subject to possible extension as provided in this Section 8.1(b), the “Outside Date”); provided, however, that the right to terminate this Agreement under this Section 8.1(b) shall not be available to Homology or Q32 if such Party’s action or failure to act has been a principal cause of the failure of the Merger to occur on or before the Outside Date and such action or failure to act constitutes a breach of this Agreement, provided, further, however, that, in the event that the SEC has not declared effective under the Securities Act the Registration Statement by the date which is twenty-five (25) days prior to the Outside Date, then either Homology or Q32 shall be entitled to extend the Outside Date for an additional ninety (90) days;

(c) by either Homology and Q32 if a court of competent jurisdiction or other Governmental Authority shall have issued a final and nonappealable Order, or shall have taken any other action, having the effect of permanently restraining, enjoining or otherwise prohibiting the Contemplated Transactions;

(d) by Homology if the Required Q32 Stockholder Vote shall not have been obtained and evidence thereof delivered to Homology within fifteen (15) days of the Registration Statement becoming effective in accordance with the provisions of the Securities Act; provided, however, that once the Required Q32 Stockholder Vote has been obtained, Homology may not terminate this Agreement pursuant to this Section 8.1(d);

(e) by either Homology or Q32 if (i) the Homology Stockholder Meeting (including any adjournments and postponements thereof) shall have been held and completed and Homology’s stockholders shall have taken a final vote on the Homology Stockholder Matters and (ii) the Homology Stockholder Matters shall not have been approved at the Homology Stockholder Meeting (or at any adjournment or postponement thereof) by the Required Homology Stockholder Vote;

(f) by Q32 (at any time prior to the approval of the Homology Stockholder Matters by the Required Homology Stockholder Vote) if a Homology Triggering Event shall have occurred;

(g) by Homology (at any time prior to the adoption of this Agreement and the approval of the Contemplated Transactions by the Required Q32 Stockholder Vote) if a Q32 Triggering Event shall have occurred;

(h) by Q32, upon a breach of any representation, warranty, covenant or agreement set forth in this Agreement by Homology or Merger Sub or if any representation or warranty of Homology or Merger Sub shall have become inaccurate, in either case, such that the conditions set forth in Section 6.2(a) or Section 6.2(b) would not be satisfied as of the time of such breach or as of the time such representation or warranty shall have become inaccurate; provided that Q32 is not then in material breach of any representation, warranty, covenant or agreement under this Agreement; provided, further, that if such inaccuracy in Homology’s or Merger Sub’s representations and warranties or breach by Homology or Merger Sub is curable by Homology or Merger Sub, then this Agreement shall not terminate pursuant to this Section 8.1(h) as a result of such particular breach or inaccuracy until the expiration of a 30-day period commencing upon delivery of written notice from Q32 to

 

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Homology or Merger Sub of such breach or inaccuracy and its intention to terminate pursuant to this Section 8.1(h) (it being understood that this Agreement shall not terminate pursuant to this Section 8.1(h) as a result of such particular breach or inaccuracy if such breach by Homology or Merger Sub is cured prior to such termination becoming effective); or

(i) by Homology, upon a breach of any representation, warranty, covenant or agreement set forth in this Agreement by Q32 or if any representation or warranty of Q32 shall have become inaccurate, in either case, such that the conditions set forth in Section 6.3(a) or Section 6.3(b) would not be satisfied as of the time of such breach or as of the time such representation or warranty shall have become inaccurate; provided that Homology is not then in material breach of any representation, warranty, covenant or agreement under this Agreement; provided, further, that if such inaccuracy in Q32’s representations and warranties or breach by Q32 is curable by Q32 then this Agreement shall not terminate pursuant to this Section 8.1(i) as a result of such particular breach or inaccuracy until the expiration of a 30-day period commencing upon delivery of written notice from Homology to Q32 of such breach or inaccuracy and its intention to terminate pursuant to this Section 8.1(i) (it being understood that this Agreement shall not terminate pursuant to this Section 8.1(i) as a result of such particular breach or inaccuracy if such breach by Q32 is cured prior to such termination becoming effective).

The Party desiring to terminate this Agreement pursuant to this Section 8.1 (other than pursuant to Section 8.1(a)) shall give a notice of such termination to the other Party specifying the provisions hereof pursuant to which such termination is made and the basis therefor described in reasonable detail.

8.2 Effect of Termination. In the event of the termination of this Agreement as provided in Section 8.1, this Agreement shall be of no further force or effect; provided, however, that (a) this Section 8.2, Section 8.3, and Article IX shall survive the termination of this Agreement and shall remain in full force and effect and (b) the termination of this Agreement and the provisions of Section 8.3 shall not relieve any Party of any liability for fraud or for any willful and material breach of any representation, warranty, covenant, obligation or other provision contained in this Agreement.

8.3 Expenses; Termination Fees.

(a) Except as set forth in this Section 8.3 all fees and expenses incurred in connection with this Agreement and the Contemplated Transactions shall be paid by the Party incurring such expenses, whether or not the Merger is consummated; provided, however, that (i) Homology and Q32 shall pay the costs and expenses incurred in relation to the filings by the Parties under any antitrust Law applicable to this Agreement and the transactions contemplated hereby, and (ii) Homology and Q32 shall share equally all fees and expenses incurred in relation to the printing and filing with the SEC of the Registration Statement (including any financial statements and exhibits) and any amendments or supplements thereto and paid to a financial printer or the SEC.

(b) If (i) this Agreement is terminated by Homology or Q32 pursuant to Section 8.1(b), (ii) at any time after the date of this Agreement and prior to the Homology Stockholder Meeting an Acquisition Proposal with respect to Homology shall have been publicly announced, disclosed or otherwise communicated to the Homology Board (and shall not have been withdrawn) and (iii) within twelve (12) months after the date of such termination, Homology enters into a definitive agreement with respect to a Subsequent Transaction or consummates a Subsequent Transaction, then Homology shall pay to Q32, within four (4) Business Days after termination (or, if applicable, upon such entry into a definitive agreement and/or consummation of a Subsequent Transaction), a nonrefundable fee in an amount equal to $2,400,000.

(c) If this Agreement is terminated by Q32 pursuant to Section 8.1(f), then Homology shall pay to Q32 within four (4) Business Days after termination, a nonrefundable fee in an amount equal to $2,400,000.

(d) If this Agreement is terminated by Homology pursuant to Section 8.1(d) or Section 8.1(g), then Q32 shall pay to Homology, within four (4) Business Days after termination, a nonrefundable fee in an amount equal to $5,850,000.

 

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(e) If either Party fails to pay when due any amount payable by it under this Section 8.3, then (i) such Party shall reimburse the other Party for reasonable costs and expenses (including reasonable fees and disbursements of counsel) incurred in connection with the collection of such overdue amount and the enforcement by the other Party of its rights under this Section 8.3 and (ii) such Party shall pay to the other Party interest on such overdue amount (for the period commencing as of the date such overdue amount was originally required to be paid and ending on the date such overdue amount is actually paid to the other Party in full) at a rate per annum equal to the “prime rate” (as announced by Bank of America or any successor thereto) in effect on the date such overdue amount was originally required to be paid plus three percent.

(f) The Parties agree that, subject to Section 8.2, the payment of the fees and expenses set forth in this Section 8.3 shall be the sole and exclusive remedy of each Party following a termination of this Agreement under the circumstances described in this Section 8.3 that result in the payment of such fees, it being understood that in no event shall either Homology or Q32 be required to pay the individual fees or damages payable pursuant to this Section 8.3 on more than one occasion. Subject to Section 8.2, following the termination of this Agreement under the circumstances described in this Section 8.3 and the payment of the fees set forth in this Section 8.3 by a Party, (i) such Party shall have no further liability to the other Party in connection with or arising out of this Agreement or the termination thereof, any breach of this Agreement by the other Party giving rise to such termination, or the failure of the Contemplated Transactions to be consummated, (ii) no other Party or their respective Affiliates shall be entitled to bring or maintain any other claim, action or proceeding against such Party or seek to obtain any recovery, judgment or damages of any kind against such Party (or any partner, member, stockholder, director, officer, employee, Subsidiary, affiliate, agent or other representative of such Party) in connection with or arising out of this Agreement or the termination thereof, any breach by such Party giving rise to such termination or the failure of the Contemplated Transactions to be consummated and (iii) all other Parties and their respective Affiliates shall be precluded from any other remedy against such Party and its Affiliates, at law or in equity or otherwise, in connection with or arising out of this Agreement or the termination thereof, any breach by such Party giving rise to such termination or the failure of the Contemplated Transactions to be consummated. Each of the Parties acknowledges that (x) the agreements contained in this Section 8.3 are an integral part of the Contemplated Transactions, (y) without these agreements, the Parties would not enter into this Agreement and (z) any amount payable pursuant to this Section 8.3 is not a penalty, but rather is liquidated damages in a reasonable amount that will compensate the Parties in the circumstances in which such amount is payable.

ARTICLE IX

GENERAL PROVISIONS

9.1 Non-Survival of Representations and Warranties. The representations and warranties of Q32, Homology and Merger Sub contained in this Agreement or any certificate or instrument delivered pursuant to this Agreement shall terminate at the Effective Time, and only the covenants that by their terms survive the Effective Time and this Article IX shall survive the Effective Time.

9.2 Amendment. This Agreement may be amended with the approval of the respective boards of directors of Q32, Merger Sub and Homology at any time (whether before or after obtaining the Required Q32 Stockholder Vote and the Required Homology Stockholder Vote); provided, however, that after any such approval of this Agreement by a Party’s stockholders or members, no amendment shall be made which by Law requires further approval of such stockholders or members without the further approval of such stockholders or members. This Agreement may not be amended except by an instrument in writing signed on behalf of each of Q32, Merger Sub and Homology.

9.3 Waiver.

(a) Any provision hereof may be waived by the waiving Party solely on such Party’s own behalf, without the consent of any other Party. No failure on the part of any Party to exercise any power, right, privilege or

 

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remedy under this Agreement, and no delay on the part of any Party in exercising any power, right, privilege or remedy under this Agreement, shall operate as a waiver of such power, right, privilege or remedy; and no single or partial exercise of any such power, right, privilege or remedy shall preclude any other or further exercise thereof or of any other power, right, privilege or remedy.

(b) No Party shall be deemed to have waived any claim arising out of this Agreement, or any power, right, privilege or remedy under this Agreement, unless the waiver of such claim, power, right, privilege or remedy is expressly set forth in a written instrument duly executed and delivered on behalf of such Party and any such waiver shall not be applicable or have any effect except in the specific instance in which it is given.

9.4 Entire Agreement; Counterparts; Exchanges by Electronic Transmission or Facsimile. This Agreement and the other schedules, exhibits, certificates, instruments and agreements referred to in this Agreement constitute the entire agreement and supersede all prior agreements and understandings, both written and oral, among or between any of the Parties with respect to the subject matter hereof and thereof; provided, however, that the Confidentiality Agreement shall not be superseded and shall remain in full force and effect in accordance with its terms. This Agreement may be executed in several counterparts, each of which shall be deemed an original and all of which shall constitute one and the same instrument. The exchange of a fully executed Agreement (in counterparts or otherwise) by all Parties by facsimile or electronic transmission in PDF format shall be sufficient to bind the Parties to the terms and conditions of this Agreement.

9.5 Applicable Law; Jurisdiction. This Agreement shall be governed by, and construed in accordance with, the laws of the State of Delaware, regardless of the laws that might otherwise govern under applicable principles of conflicts of laws. In any action or proceeding between any of the Parties arising out of or relating to this Agreement or any of the Contemplated Transactions, each of the Parties: irrevocably and unconditionally (a) consents and submits to the exclusive jurisdiction and venue of the Court of Chancery of the State of Delaware or, to the extent such court does not have subject matter jurisdiction, the Superior Court of the State of Delaware or the United States District Court for the District of Delaware, (b) agrees that all claims in respect of such action or proceeding shall be heard and determined exclusively in accordance with clause (a) of this Section 9.5, (c) waives any objection to laying venue in any such action or proceeding in such courts, (d) waives any objection that such courts are an inconvenient forum or do not have jurisdiction over any Party, (e) agrees that service of process upon such Party in any such action or proceeding shall be effective if notice is given in accordance with Section 9.7 of this Agreement and (f) irrevocably and unconditionally waives the right to trial by jury.

9.6 Assignability. This Agreement shall be binding upon, and shall be enforceable by and inure solely to the benefit of, the Parties and their respective successors and permitted assigns; provided, however, that neither this Agreement nor any of a Party’s rights or obligations hereunder may be assigned or delegated by such Party without the prior written consent of the other Party, and any attempted assignment or delegation of this Agreement or any of such rights or obligations by such Party without the other Party’s prior written consent shall be void and of no effect.

9.7 Notices. All notices and other communications hereunder shall be in writing and shall be deemed to have been duly delivered and received hereunder (a) one (1) Business Day after being sent for next Business Day delivery, fees prepaid, via a reputable international overnight courier service, (b) upon delivery in the case of delivery by hand or (c) on the date delivered in the place of delivery if sent by email or facsimile (with a written or electronic confirmation of delivery) prior to 6:00 p.m. New York City time, otherwise on the next succeeding Business Day, in each case to the intended recipient as set forth below:

if to Homology or Merger Sub:

Homology Medicines, Inc.

One Patriots Park

Bedford, MA 01730

Attention: Paul Alloway

Email: [***]

 

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with a copy to (which shall not constitute notice):

Latham & Watkins LLP

200 Clarendon Street

Boston, MA 02116

Attention: Peter Handrinos; Leah Sauter

Email: [***]

if to Q32:

Q32 Bio Inc.

830 Winter St.

Waltham, MA 02451

Attention: Jodie Morrison

Email: [***]

with a copy to (which shall not constitute notice):

Goodwin Procter LLP

100 Northern Avenue

Boston, MA 02210

Attention: John T. Haggerty; Jacqueline Mercier; Tevia K. Pollard

Email: [***]

9.8 Cooperation. Each Party agrees to cooperate fully with the other Party and to execute and deliver such further documents, certificates, agreements and instruments and to take such other actions as may be reasonably requested by the other Party to evidence or reflect the Contemplated Transactions and to carry out the intent and purposes of this Agreement.

9.9 Severability. Any term or provision of this Agreement that is invalid or unenforceable in any situation in any jurisdiction shall not affect the validity or enforceability of the remaining terms and provisions of this Agreement or the validity or enforceability of the offending term or provision in any other situation or in any other jurisdiction. If a final judgment of a court of competent jurisdiction declares that any term or provision of this Agreement is invalid or unenforceable, the Parties agree that the court making such determination shall have the power to limit such term or provision, to delete specific words or phrases or to replace such term or provision with a term or provision that is valid and enforceable and that comes closest to expressing the intention of the invalid or unenforceable term or provision, and this Agreement shall be valid and enforceable as so modified. In the event such court does not exercise the power granted to it in the prior sentence, the Parties agree to replace such invalid or unenforceable term or provision with a valid and enforceable term or provision that will achieve, to the extent possible, the economic, business and other purposes of such invalid or unenforceable term or provision.

9.10 Other Remedies; Specific Performance. Except as otherwise provided herein, any and all remedies herein expressly conferred upon a Party will be deemed cumulative with and not exclusive of any other remedy conferred hereby, or by law or equity upon such Party, and the exercise by a Party of any one remedy will not preclude the exercise of any other remedy. The Parties agree that irreparable damage for which monetary damages, even if available, would not be an adequate remedy, would occur in the event that any of the provisions of this Agreement were not performed in accordance with their specific terms (including failing to take such actions as are required of it hereunder to consummate this Agreement) or were otherwise breached. It is accordingly agreed that the Parties shall be entitled to an injunction or injunctions to prevent breaches of this Agreement and to enforce specifically the terms and provisions hereof in any court of the United States or any state having jurisdiction, this being in addition to any other remedy to which they are entitled at law or in equity, and each of the Parties waives any bond, surety or other security that might be required of any other Party with respect thereto. Each of the Parties further agrees that it will not oppose the granting of an injunction, specific performance or other equitable relief on the basis that any other Party has an adequate remedy at law or that any award of specific performance is not an appropriate remedy for any reason at law or in equity.

 

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9.11 No Third-Party Beneficiaries.

Nothing in this Agreement, express or implied, is intended to or shall confer upon any Person (other than the Parties and the D&O Indemnified Parties to the extent of their respective rights pursuant to Section 5.15) any right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.

[Remainder of page intentionally left blank]

 

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the date first above written.

 

HOMOLOGY MEDICINES, INC.
By:   /s/ Albert Seymour
Name: Albert Seymour
Title:   President and Chief Executive Officer
KENOBI MERGER SUB, INC.
By:   /s/ Paul Alloway
Name: Paul Alloway
Title:   President
Q32 BIO INC.
By:   /s/ Jodie Morrison
Name: Jodie Morrison
Title:   Chief Executive Officer

[Signature Page to Merger Agreement]

 

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Exhibit A

Form of Homology Stockholder Support Agreement

[Intentionally Omitted]


Exhibit B

Form of Q32 Stockholder Support Agreement

[Intentionally Omitted]


Exhibit C

Form of Homology Lock-Up Agreement

[Intentionally Omitted]


Exhibit D

Form of Q32 Lock-Up Agreement

[Intentionally Omitted]


Exhibit E

Form of CVR Agreement

[Intentionally Omitted]

Exhibit 10.1

Final Form

Q32 BIO INC.

SUPPORT AGREEMENT

THIS SUPPORT AGREEMENT (this “Agreement”), dated as of November 16, 2023 is made by and among Homology Medicines, Inc., a Delaware corporation (“Homology”), Q32 Bio Inc., a Delaware corporation (the “Company”), and the undersigned holders (each a “Stockholder”) of shares of capital stock (the “Shares”) of the Company.

WHEREAS, Homology, Kenobi Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Homology (“Merger Sub”), and the Company, have entered into an Agreement and Plan of Merger, dated as of even date herewith (the “Merger Agreement”), providing for the merger of Merger Sub with and into the Company (the “Merger”);

WHEREAS, each Stockholder beneficially owns and has sole or shared voting power with respect to the number of Shares, and holds Q32 Options to acquire the number of Shares, indicated opposite such Stockholder’s name on Schedule 1 attached hereto;

WHEREAS, as an inducement and a condition to the willingness of the Company to enter into the Merger Agreement, each Stockholder has agreed to enter into and perform this Agreement; and

WHEREAS, all capitalized terms used in this Agreement without definition herein shall have the meanings ascribed to them in the Merger Agreement.

NOW, THEREFORE, in consideration of, and as a condition to, the Company’s entering into the Merger Agreement, each Stockholder, Homology and the Company agree as follows:

1. Agreement to Vote Shares. Each Stockholder agrees that, prior to the Expiration Date (as defined in Section 2 below), at any meeting of the stockholders of the Company or any adjournment or postponement thereof, or in connection with any written consent of the stockholders (or any class or series of stockholders, as applicable) of the Company, with respect to the Merger, the Merger Agreement or any Acquisition Proposal, such Stockholder shall:

(a) appear at such meeting or otherwise cause the Shares and any New Shares (as defined in Section 3 below) to be counted as present thereat for purposes of calculating a quorum;

(b) from and after the date hereof until the Expiration Date, vote (or cause to be voted), or deliver a written consent (or cause a written consent to be delivered) covering all of the Shares and any New Shares that Stockholder shall be entitled to so vote: (i) in favor of (A) all of the matters set forth in the Q32 Stockholder Written Consent [, which Q32 Stockholder Written Consent shall be in a form acceptable to Stockholder]1 and (B) any matter that could reasonably be expected to facilitate the Merger, the Concurrent Financing and the Contemplated Transactions; (ii) against any action or agreement that would result in a breach of any representation, warranty, covenant or obligation of the Company in the Merger Agreement; (iii) against any Acquisition Proposal, or any agreement, transaction or other matter or action that is intended to, or would reasonably be expected to, impede, interfere with, delay, postpone, discourage or materially and adversely affect the consummation of the Merger, the Concurrent Financing and all of the other Contemplated Transactions; (iv) to approve any proposal to adjourn or postpone the meeting to a later date, if there are not sufficient votes for the adoption of the Merger Agreement on the date on which such meeting is held; and (v) to the extent applicable, in favor of an election to convert all of the Company Preferred Stock held by Stockholder into Company Common Stock [in accordance with the provisions of the Company’s certificate of incorporation as in effect on the date hereof].1 Stockholder shall not take or commit or agree to take any action inconsistent with the foregoing.

 

 

1 

The bracketed language is applicable to certain institutional investors.

 

1


2. Expiration Date. As used in this Agreement, the term “Expiration Date” shall mean the earlier to occur of (a) the Effective Time, (b) such date and time as the Merger Agreement shall be terminated pursuant to Article VIII thereof or otherwise, (c) any amendment to the Merger Agreement is effected without the Stockholder’s written consent that [(i)] 1 decreases the amount, or changes the form, of consideration payable to all stockholders of the Company pursuant to the terms of the Merger Agreement or [(ii) otherwise changes the terms and conditions of the Merger, the Concurrent Financing or the other Contemplated Transaction in a manner materially adverse to such Stockholder,]1 (d) the mutual written agreement of the parties to terminate this Agreement [or (e) the one year anniversary of the date of this Agreement].1

3. Additional Acquisitions. Each Stockholder agrees that any shares of capital stock or other equity securities of the Company that such Stockholder acquires or with respect to which such Stockholder otherwise acquires sole or shared voting power (including any proxy) after the execution of this Agreement and prior to the Expiration Date, whether by the exercise of any Q32 Options, Q32 Warrants or otherwise, including, without limitation, by gift, succession, in the event of a stock split or as a dividend or distribution of any Shares (“New Shares”), shall be subject to the terms and conditions of this Agreement to the same extent as if they constituted the Shares.

4. Agreement to Retain Shares. From and after the date hereof until the Expiration Date, each Stockholder shall not, directly or indirectly, (a) sell, assign, transfer, tender, or otherwise dispose of (including, without limitation, by the creation of any Liens (as defined in Section 5(c) below)) any Shares or any New Shares, (b) deposit any Shares or New Shares into a voting trust or enter into a voting agreement or similar arrangement with respect to such Shares or New Shares or grant any proxy or power of attorney with respect thereto (other than this Agreement), (c) enter into any Contract, option, commitment or other arrangement or understanding with respect to the direct or indirect sale, transfer, assignment or other disposition of (including, without limitation, by the creation of any Liens) any Shares or New Shares, or (d) take any action that would make any representation or warranty of such Stockholder contained herein untrue or incorrect or have the effect of preventing or disabling such Stockholder from performing such Stockholder’s obligations under this Agreement. Any action taken in violation of the foregoing sentence shall be null and void ab initio. Notwithstanding the foregoing, each Stockholder may make (1) transfers by will or by operation of Law or other transfers for estate-planning purposes, in which case this Agreement shall bind the transferee, (2) with respect to such Stockholder’s Q32 Options (and any Shares underlying such Q32 Options) which expire on or prior to the Expiration Date, transfers, sale, or other disposition of Shares to the Company (or effecting a “net exercise” of a Q32 Option) as payment for the (i) exercise price of such Stockholder’s Q32 Options and (ii) taxes applicable to the exercise of such Stockholder’s Q32 Options, (3) if Stockholder is an entity, partnership or limited liability company, a transfer to one or more equityholders, partners or members of Stockholder or to an Affiliated person, corporation, trust or other Entity controlling or under common control with Stockholder [(including, for the avoidance of doubt, a fund managed by the same manager or managing member or general partner or management company or by an entity controlling, controlled by or under common control with such manager or managing member or general partner or management company of the undersigned)]1, or if Stockholder is a trust, a transfer to a beneficiary, provided that in each such case the applicable transferee has signed a voting agreement in substantially the form hereof, (4) make transfers that occur by operation of law pursuant to a qualified domestic relations order or in connection with a divorce settlement, and (5) transfers, sales or other dispositions as the Company may otherwise agree in writing in its sole discretion. If any voluntary or involuntary transfer of any Shares covered hereby shall occur (including a transfer or disposition permitted by Section 4(1) through Section 4(5), sale by a Stockholder’s trustee in bankruptcy, or a sale to a purchaser at any creditor’s or court sale), the transferee (which term, as used herein, shall include any and all transferees and subsequent transferees of the initial transferee) shall take and hold such Shares subject to all of the restrictions, liabilities and rights under this Agreement, which shall continue in full force and effect, notwithstanding that such transferee is not a Stockholder and has not executed a counterpart hereof or joinder hereto.

 

 

1 

The bracketed language is applicable to certain institutional investors.

 

2


5. Representations and Warranties of Stockholder. Each Stockholder hereby, severally but not jointly, represents and warrants to Homology and the Company as follows:

(a) If such Stockholder is an Entity: (i) such Stockholder is duly organized, validly existing and in good standing under the laws of the jurisdiction in which it is incorporated, organized or constituted, (ii) such Stockholder has all necessary power and authority to execute and deliver this Agreement, to perform such Stockholder’s obligations hereunder and to consummate the transactions contemplated hereby, and (iii) the execution and delivery of this Agreement, performance of such Stockholder’s obligations hereunder and the consummation of the transactions contemplated hereby by such Stockholder have been duly authorized by all necessary action on the part of such Stockholder and no other proceedings on the part of such Stockholder are necessary to authorize this Agreement, or to consummate the transactions contemplated hereby. If such Stockholder is an individual, such Stockholder has the legal capacity to execute and deliver this Agreement, to perform such Stockholder’s obligations hereunder and to consummate the transactions contemplated hereby;

(b) this Agreement has been duly executed and delivered by or on behalf of such Stockholder and, to such Stockholder’s knowledge and assuming this Agreement constitutes a valid and binding agreement of the Company and Homology, constitutes a valid and binding agreement with respect to such Stockholder, enforceable against such Stockholder in accordance with its terms, except as enforcement may be limited by general principles of equity whether applied in a court of Law or a court of equity and by bankruptcy, insolvency and similar Laws affecting creditors’ rights and remedies generally;

(c) Stockholder has had the opportunity to review the Merger Agreement, including the provisions relating to the payment and allocation of the consideration to be paid to the stockholders of the Company, and this Agreement with counsel of Stockholder’s own choosing. Stockholder has had an opportunity to review with its own tax advisors the tax consequences of the Merger and the Contemplated Transactions. Stockholder understands that it must rely solely on its advisors and not on any statements or representations made by Homology, the Company or any of their respective agents or representatives [, except as set forth in the Subscription Agreement (with respect to those Stockholders participating in the Concurrent Financing)]1. Stockholder understands that such Stockholder (and not Homology, the Company or the Surviving Corporation) shall be responsible for such Stockholder’s tax liability that may arise as a result of the Merger or the transactions contemplated by the Merger Agreement. Stockholder understands and acknowledges that the Company, Homology and Merger Sub are entering into the Merger Agreement in reliance upon Stockholder’s execution, delivery and performance of this Agreement.

(d) such Stockholder beneficially owns the number of Shares indicated opposite such Stockholder’s name on Schedule 1, which constitute all of the Shares owned by the Stockholder as of the date hereof. Such Stockholder will own any New Shares, free and clear of any liens, claims, charges or other encumbrances or restrictions of any kind whatsoever (“Liens”), and has sole or shared, and otherwise unrestricted, voting power with respect to such Shares or New Shares and none of the Shares or New Shares is subject to any voting trust or other agreement, arrangement or restriction with respect to the voting of the Shares or the New Shares, except as contemplated by this Agreement and the stockholder agreements and arrangements referenced in the Merger Agreement and except for customary arrangements with the Stockholder’s prime broker and/or custodian;

(e) to the knowledge of such Stockholder, the execution and delivery of this Agreement by such Stockholder does not, and the performance by such Stockholder of his, her or its obligations hereunder and the compliance by such Stockholder with any provisions hereof will not, violate or conflict with, result in a material breach of or constitute a default (or an event that with notice or lapse of time or both would become a material default) under, or give to others any rights of termination, amendment, acceleration or cancellation of, or result in the creation of any Liens on any Shares or New Shares pursuant to, any agreement, instrument, note, bond, mortgage, Contract, lease, license, permit or other obligation or any order, arbitration award, judgment or decree to which such Stockholder is a party or by which such

 

1

The bracketed language is applicable to certain institutional investors.

 

3


Stockholder is bound, or any Law, statute, rule or regulation to which such Stockholder is subject or, in the event that such Stockholder is a corporation, partnership, trust or other Entity, any bylaw or other Organizational Document of such Stockholder; except for any of the foregoing as would not reasonably be expected to prevent or delay the performance by such Stockholder of his, her or its obligations under this Agreement in any material respect;

(f) the execution and delivery of this Agreement by such Stockholder does not, and the performance of this Agreement by such Stockholder does not and will not, require any consent, approval, authorization or permit of, or filing with or notification to, any Governmental Authority or regulatory authority by such Stockholder except for applicable requirements, if any, of the Exchange Act, and except where the failure to obtain such consents, approvals, authorizations or permits, or to make such filings or notifications, would not prevent or delay the performance by such Stockholder of his, her or its obligations under this Agreement in any material respect;

(g) no investment banker, broker, finder or other intermediary is entitled to a fee or commission from Homology or the Company in respect of this Agreement based upon any Contract made by or on behalf of such Stockholder; and

(h) as of the date of this Agreement, there is no Legal Proceeding pending or, to the knowledge of such Stockholder, threatened against such Stockholder that would reasonably be expected to prevent or delay the performance by such Stockholder of his, her or its obligations under this Agreement in any material respect.

6. Irrevocable Proxy. Subject to the penultimate sentence of this Section 6, by execution of this Agreement, each Stockholder does hereby appoint the Company and any of its designees with full power of substitution and resubstitution, as such Stockholder’s true and lawful attorney and irrevocable proxy, to the fullest extent of such Stockholder’s rights with respect to the Shares, to vote and exercise all voting and related rights, including the right to sign such Stockholder’s name (solely in its capacity as a stockholder) to any Stockholder consent, if such Stockholder fails to vote his, her or its Shares solely with respect to the matters set forth in Section 1 [(b)]1 hereof by 5:00 p.m. (Eastern Time) on the day immediately preceding the meeting date (or date upon which written consents are requested to be submitted), provided the Stockholder has received information regarding the meeting or request for written consent at least five (5) Business Days before such shareholder meeting or any consent solicitation or other vote taken of the Company’s stockholders. Each Stockholder intends this proxy to be irrevocable and coupled with an interest hereunder until the Expiration Date, hereby revokes any proxy previously granted by such Stockholder with respect to the Shares and represents that none of such previously-granted proxies are irrevocable. The Stockholder hereby affirms that the proxy set forth in this Section 6 is given in connection with, and granted in consideration of, and as an inducement to the Company, Homology and Merger Sub to enter into the Merger Agreement and that such proxy is given to secure the obligations of the Stockholder under Section 1. The irrevocable proxy and power of attorney granted herein shall survive the death or incapacity of such Stockholder and the obligations of such Stockholder shall be binding on such Stockholder’s heirs, personal representatives, successors, transferees and assigns. Each Stockholder hereby agrees not to grant any subsequent powers of attorney or proxies with respect to any Shares with respect to the matters set forth in Section 1 until after the Expiration Date. With respect to any Shares that are owned beneficially by Stockholder but are not held of record by Stockholder (other than shares beneficially owned by Stockholder that are held in the name of a bank, broker or nominee), Stockholder shall take all action necessary to cause the record holder of such Shares to grant the irrevocable proxy and take all other actions provided for in this Section 6 with respect to such Shares. Notwithstanding anything contained herein to the contrary, this irrevocable proxy shall automatically terminate upon the Expiration Date.

7. Waiver of Appraisal Rights. Each Stockholder hereby waives, and agrees not to exercise or assert, any appraisal rights under applicable Law, including Section 262 of Delaware Law, in connection with the Merger.

 

 

1 

The bracketed language is applicable to certain institutional investors.

 

4


8. No Legal Actions. Each Stockholder will not in its capacity as a stockholder of the Company bring, commence, institute, maintain, prosecute or voluntarily aid any Legal Proceeding which (i) challenges the validity or seeks to enjoin the operation of any provision of this Agreement or (ii) alleges that the execution and delivery of this Agreement by such Stockholder, either alone or together with the other voting agreements and proxies to be delivered in connection with the execution of the Merger Agreement, or the approval of the Merger Agreement and the Contemplated Transactions by the Company Board, constitutes a breach of any fiduciary duty of the Q32 Board or any member thereof.

9. Other Remedies; Specific Performance. Except as otherwise provided herein, any and all remedies herein expressly conferred upon a party will be deemed cumulative with, and not exclusive of, any other remedy conferred hereby, or by Law or equity upon such party, and the exercise by a party of any one remedy will not preclude the exercise of any other remedy. The parties hereto agree that irreparable damage would occur in the event that any of the provisions of this Agreement were not performed in accordance with their specific terms or were otherwise breached. It is accordingly agreed that the parties shall be entitled to an injunction or injunctions to prevent breaches of this Agreement and to enforce specifically the terms and provisions hereof without the need of posting bond in any court of the United States or any state having jurisdiction, this being in addition to any other remedy to which they are entitled at Law or in equity.

10. Directors and Officers. This Agreement shall apply to each Stockholder solely in such Stockholder’s capacity as a stockholder of the Company and/or holder of Q32 Options and/or Q32 Warrants not in such Stockholder’s capacity as a director, officer or employee of the Company or any of its Subsidiaries or in such Stockholder’s capacity as a trustee or fiduciary of any employee benefit plan or trust. Notwithstanding any provision of this Agreement to the contrary, nothing in this Agreement shall (or require Stockholder to attempt to) limit or restrict a director and/or officer of the Company in the exercise of his or her fiduciary duties consistent with the terms of the Merger Agreement as a director and/or officer of the Company or in his or her capacity as a trustee or fiduciary of any employee benefit plan or trust or prevent or be construed to create any obligation on the part of any director and/or officer of the Company or any trustee or fiduciary of any employee benefit plan or trust from taking any action in his or her capacity as such director, officer, trustee and/or fiduciary.

11. No Ownership Interest. Nothing contained in this Agreement shall be deemed to vest in the Company any direct or indirect ownership or incidence of ownership of or with respect to any Shares. All rights, ownership and economic benefits of and relating to the Shares shall remain vested in and belong to such Stockholder, and the Company does not have authority to manage, direct, superintend, restrict, regulate, govern, or administer any of the policies or operations of the Company or exercise any power or authority to direct such Stockholder in the voting of any of the Shares, except as otherwise provided herein.

12. Termination. This Agreement shall terminate and shall have no further force or effect as of the Expiration Date. Notwithstanding the foregoing, upon termination or expiration of this Agreement, no party shall have any further obligations or liabilities under this Agreement; provided, however, nothing set forth in this Section 12 or elsewhere in this Agreement shall relieve any party from liability for any fraud or for any willful and material breach of this Agreement prior to termination hereof.

13. Further Assurances. Each Stockholder shall, from time to time, execute and deliver, or cause to be executed and delivered, such additional or further consents, documents and other instruments as the Company or Homology may reasonably request for the purpose of effectively carrying out the transactions contemplated by this Agreement and the Contemplated Transactions. [Reserved]1

14. Disclosure. Each Stockholder hereby agrees that Homology and the Company may publish and disclose in the Proxy Statement, any prospectus filed with any regulatory authority in connection with the Contemplated Transactions and any related documents filed with such regulatory authority and as otherwise required by Law,

 

1 

The bracketed language is applicable to certain institutional investors.

 

5


such Stockholder’s identity and ownership of Shares and the nature of such Stockholder’s commitments, arrangements and understandings under this Agreement and may further file this Agreement as an exhibit to the Proxy Statement or prospectus or in any other filing made by Homology or the Company as required by Law or the terms of the Merger Agreement, including with the SEC or other regulatory authority, relating to the Contemplated Transactions, all subject to prior review and a reasonable opportunity to comment by Stockholder’s counsel. Prior to the Closing, each Stockholder shall not, and shall use its reasonable best efforts to cause its representatives not to, directly or indirectly, make any press release, public announcement or other public communication regarding the Merger without the prior written consent of Homology and the Company, provided that the foregoing shall not limit or affect any actions taken by such Stockholder (or any affiliated officer or director of such Stockholder) that would be permitted to be taken by such Stockholder, Homology or the Company pursuant to the Merger Agreement; provided, further, that the foregoing shall not effect any actions of Stockholder the prohibition of which would be prohibited under applicable Law and shall not prohibit Stockholder or its affiliates from making any publicly-available filings required by applicable law, regulation or legal process.

15. Notice. All notices and other communications hereunder shall be in writing and shall be deemed given if delivered personally or sent by overnight courier (providing proof of delivery), by facsimile transmission (providing confirmation of transmission) or by electronic transmission (providing confirmation of transmission) to the Company or Homology, as the case may be, in accordance with Section 9.7 of the Merger Agreement and to each Stockholder at his, her or its address or email address (providing confirmation of transmission) set forth on Schedule 1 attached hereto (or at such other address for a party as shall be specified by like notice).

16. Severability. Any term or provision of this Agreement that is invalid or unenforceable in any situation in any jurisdiction shall not affect the validity or enforceability of the remaining terms and provisions of this Agreement or the validity or enforceability of the offending term or provision in any other situation or in any other jurisdiction. If a final judgment of a court of competent jurisdiction declares that any term or provision of this Agreement is invalid or unenforceable, the parties hereto agree that the court making such determination shall have the power to limit such term or provision, to delete specific words or phrases or to replace such term or provision with a term or provision that is valid and enforceable and that comes closest to expressing the intention of the invalid or unenforceable term or provision, and this Agreement shall be valid and enforceable as so modified. In the event such court does not exercise the power granted to it in the prior sentence, the parties hereto agree to replace such invalid or unenforceable term or provision with a valid and enforceable term or provision that will achieve, to the extent possible, the economic, business and other purposes of such invalid or unenforceable term or provision.

17. Assignability. This Agreement shall be binding upon, and shall be enforceable by and inure solely to the benefit of, the parties hereto and their respective successors and assigns; provided, however, that neither this Agreement nor any of a party’s rights or obligations hereunder may be assigned or delegated by such party without the prior written consent of the other parties hereto, and any attempted assignment or delegation of this Agreement or any of such rights or obligations by such party without the other party’s prior written consent shall be void and of no effect. Nothing in this Agreement, express or implied, is intended to or shall confer upon any Person (other than the parties hereto) any right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.

18. No Waivers. No waivers of any breach of this Agreement extended by the Company or Homology to such Stockholder shall be construed as a waiver of any rights or remedies of the Company or Homology, as applicable, with respect to any other stockholder of the Company who has executed an agreement substantially in the form of this Agreement with respect to Shares held or subsequently held by such stockholder or with respect to any subsequent breach of Stockholder or any other such stockholder of the Company. No waiver of any provisions hereof by any party shall be deemed a waiver of any other provisions hereof by any such party, nor shall any such waiver be deemed a continuing waiver of any provision hereof by such party.

 

6


19. Applicable Law; Jurisdiction. This Agreement shall be governed by, and construed in accordance with, the Laws of the state of Delaware, regardless of the Laws that might otherwise govern under applicable principles of conflicts of Laws. In any action or Legal Proceeding between any of the parties arising out of or relating to this Agreement, each of the parties: (i) irrevocably and unconditionally consents and submits to the exclusive jurisdiction and venue of the Court of Chancery of the state of Delaware or to the extent such court does not have subject matter jurisdiction, the Superior Court of the State of Delaware or the United States District Court for the District of Delaware, (ii) agrees that all claims in respect of such action or Legal Proceeding shall be heard and determined exclusively in accordance with clause (i) of this Section 19, (iii) waives any objection to laying venue in any such action or Legal Proceeding in such courts, (iv) waives any objection that such courts are an inconvenient forum or do not have jurisdiction over any party, and (v) agrees that service of process upon such party in any such action or Legal Proceeding shall be effective if notice is given in accordance with Section 15 of this Agreement. Each party irrevocably consents to service of process inside or outside the territorial jurisdiction of the courts referred to in this Section 19 in the manner provided for notices in Section 15. Nothing in this Agreement will affect the right of any party to serve process in any other manner permitted by applicable Law.

20. Waiver of Jury Trial. The parties hereto hereby waive any right to trial by jury with respect to any action or Legal Proceeding related to or arising out of this Agreement, any document executed in connection herewith and the matters contemplated hereby and thereby.

21. No Agreement Until Executed. Irrespective of negotiations among the parties or the exchanging of drafts of this Agreement, this Agreement shall not constitute or be deemed to evidence a Contract, agreement, arrangement or understanding between the parties hereto unless and until (a) the Q32 Board has approved, for purposes of any applicable anti-takeover Laws and regulations and any applicable provision of the certificate of incorporation of the Company, the Merger Agreement and the Contemplated Transactions, (b) the Merger Agreement is executed by all parties thereto, and (c) this Agreement is executed by all parties hereto.

22. Entire Agreement; Counterparts; Exchanges by Electronic Transmission. This Agreement and the other agreements referred to in this Agreement constitute the entire agreement and supersede all prior agreements and understandings, both written and oral, among or between any of the parties with respect to the subject matter hereof and thereof. This Agreement may be executed in several counterparts, each of which shall be deemed an original and all of which shall constitute one and the same instrument. The exchange of a fully executed Agreement (in counterparts or otherwise) by all parties by facsimile or electronic transmission via “.pdf” shall be sufficient to bind the parties to the terms and conditions of this Agreement.

23. Amendment. This Agreement may not be amended, supplemented or modified, and no provisions hereof may be modified or waived, except by an instrument in writing signed on behalf of each party hereto; provided, however, that the rights or obligations of any Stockholder may be waived, amended or otherwise modified in a writing signed by Homology, the Company and such Stockholder.

24. Fees and Expenses. Except as otherwise specifically provided herein, [or in any separate agreement with the Company,]1 the Merger Agreement or any other agreement contemplated by the Merger Agreement to which a party hereto is a party, each party hereto shall bear its own expenses in connection with this Agreement and the transactions contemplated hereby.

25. Voluntary Execution of Agreement. This Agreement is executed voluntarily and without any duress or undue influence on the part or behalf of the parties. Each of the parties hereby acknowledges, represents and warrants that (i) it has read and fully understood the Merger Agreement including the provisions relating to the payment and allocation of the consideration to be paid to stockholders of the Company as well as holders of Q32 Options, this Agreement, and the implications and consequences thereof; (ii) it has been represented in the

 

1 

The bracketed language is applicable to certain institutional investors.

 

7


preparation, negotiation, and execution of this Agreement by legal counsel of its own choice, or it has made a voluntary and informed decision to decline to seek such counsel; and (iii) it is fully aware of the legal and binding effect of this Agreement.

26. Definition of Merger Agreement. For purposes of this Agreement, the term “Merger Agreement” may include such agreement as amended or modified as long as such amendments or modifications (a) do not (i) change the form or amount of consideration payable under the Merger Agreement, (ii) extend the Outside Date past May 16, 2024 (other than any extension provided for in Section 8.1(b) of the Merger Agreement with respect to the Registration Statement), or (iii) otherwise change the terms and conditions of the Merger, the Concurrent Financing or the other Contemplated Transaction in a manner materially adverse to such Stockholder or (b) have been agreed to in writing by such Stockholder.

27. Construction.

(a) For purposes of this Agreement, whenever the context requires: the singular number shall include the plural, and vice versa; the masculine gender shall include the feminine and neuter genders; the feminine gender shall include the masculine and neuter genders; and the neuter gender shall include masculine and feminine genders.

(b) The parties hereto agree that any rule of construction to the effect that ambiguities are to be resolved against the drafting party shall not be applied in the construction or interpretation of this Agreement.

(c) As used in this Agreement, the words “include” and “including,” and variations thereof, shall not be deemed to be terms of limitation, but rather shall be deemed to be followed by the words “without limitation.”

(d) Except as otherwise indicated, all references in this Agreement to “Sections,” and “Schedules” are intended to refer to Sections of this Agreement and Schedules to this Agreement, respectively.

(e) The underlined headings contained in this Agreement are for convenience of reference only, shall not be deemed to be a part of this Agreement and shall not be referred to in connection with the construction or interpretation of this Agreement.

[Remainder of Page has Intentionally Been Left Blank]

 

 

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EXECUTED as of the date first above written.
    [STOCKHOLDER]
    Signature:                                                         

[Signature Page to Q32 Support Agreement]


EXECUTED as of the date first above written.

 

HOMOLOGY MEDICINES, INC.
By:  

 

Name:
Title:
Q32 BIO INC.
By:  

 

Name:
Title:

[Signature Page to Q32 Support Agreement]


SCHEDULE 1

[Intentionally Omitted]

Exhibit 10.2

Execution Version

HOMOLOGY MEDICINES, INC.

SUPPORT AGREEMENT

THIS SUPPORT AGREEMENT (this “Agreement”), dated as of November 16, 2023 is made by and among Homology Medicines, Inc., a Delaware corporation (“Homology”), Q32 Bio Inc., a Delaware corporation (the “Company”), and the undersigned holders (each a “Stockholder”) of shares of capital stock (the “Shares”) of Homology.

WHEREAS, Homology, Kenobi Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Homology (“Merger Sub”), and the Company, have entered into an Agreement and Plan of Merger, dated as of even date herewith (the “Merger Agreement”), providing for the merger of Merger Sub with and into the Company (the “Merger”);

WHEREAS, each Stockholder beneficially owns and has sole or shared voting power with respect to the number of Shares, and holds Homology Options to acquire the number of Shares, indicated opposite such Stockholder’s name on Schedule 1 attached hereto;

WHEREAS, as an inducement and a condition to the willingness of the Company to enter into the Merger Agreement, each Stockholder has agreed to enter into and perform this Agreement; and

WHEREAS, all capitalized terms used in this Agreement without definition herein shall have the meanings ascribed to them in the Merger Agreement.

NOW, THEREFORE, in consideration of, and as a condition to, the Company’s entering into the Merger Agreement, each Stockholder, Homology and the Company agree as follows:

1. Agreement to Vote Shares. Each Stockholder agrees that, prior to the Expiration Date (as defined in Section 2 below), at any meeting of the stockholders of Homology or any adjournment or postponement thereof, or in connection with any written consent of the stockholders (or any class or series of stockholders, as applicable) of Homology, with respect to the Merger, the Merger Agreement or any Acquisition Proposal, such Stockholder shall:

(a) appear at such meeting or otherwise cause the Shares and any New Shares (as defined in Section 3 below) to be counted as present thereat for purposes of calculating a quorum;

(b) from and after the date hereof until the Expiration Date, vote (or cause to be voted), or deliver a written consent (or cause a written consent to be delivered) covering all of the Shares and any New Shares that Stockholder shall be entitled to so vote: (i) in favor of (A) all of the Homology Stockholder Matters and (B) any matter that could reasonably be expected to facilitate the Merger, the Concurrent Financing and the Contemplated Transactions; (ii) against any action or agreement that would result in a breach of any representation, warranty, covenant or obligation of Homology in the Merger Agreement; (iii) against any Acquisition Proposal, or any agreement, transaction or other matter that is intended to, or would reasonably be expected to, impede, interfere with, delay, postpone, discourage or materially and adversely affect the consummation of the Merger, the Concurrent Financing and all of the other Contemplated Transactions; (iv) to approve any proposal to adjourn or postpone the meeting to a later date, if there are not sufficient votes for the adoption of the Merger Agreement on the date on which such meeting is held.

2. Expiration Date. As used in this Agreement, the term “Expiration Date” shall mean the earlier to occur of (a) the Effective Time, (b) such date and time as the Merger Agreement shall be terminated pursuant to Article VIII thereof or otherwise, (c) any amendment to the Merger Agreement is effected without the Stockholder’s written consent that increases the amount, or changes the form, of consideration payable to all stockholders of the Company pursuant to the terms of the Merger Agreement or (d) the mutual written agreement of the parties to terminate this Agreement.

 

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3. Additional Acquisitions. Each Stockholder agrees that any shares of capital stock or other equity securities of Homology that such Stockholder acquires or with respect to which such Stockholder otherwise acquires sole or shared voting power (including any proxy) after the execution of this Agreement and prior to the Expiration Date, whether by the exercise of any Homology Options or otherwise, including, without limitation, by gift, succession, in the event of a stock split or as a dividend or distribution of any Shares (“New Shares”), shall be subject to the terms and conditions of this Agreement to the same extent as if they constituted the Shares.

4. Agreement to Retain Shares. From and after the date hereof until the Expiration Date, each Stockholder shall not, directly or indirectly, (a) sell, assign, transfer, tender, or otherwise dispose of (including, without limitation, by the creation of any Liens (as defined in Section 5(c) below)) any Shares or any New Shares, (b) deposit any Shares or New Shares into a voting trust or enter into a voting agreement or similar arrangement with respect to such Shares or New Shares or grant any proxy or power of attorney with respect thereto (other than this Agreement), (c) enter into any Contract, option, commitment or other arrangement or understanding with respect to the direct or indirect sale, transfer, assignment or other disposition of (including, without limitation, by the creation of any Liens) any Shares or New Shares, or (d) take any action that would make any representation or warranty of such Stockholder contained herein untrue or incorrect or have the effect of preventing or disabling such Stockholder from performing such Stockholder’s obligations under this Agreement. Any action taken in violation of the foregoing sentence shall be null and void ab initio. Notwithstanding the foregoing, each Stockholder may make (1) transfers by will or by operation of Law or other transfers for estate-planning purposes, in which case this Agreement shall bind the transferee, (2) with respect to such Stockholder’s Homology Options (and any Shares underlying such Homology Options) which expire on or prior to the Expiration Date, transfers, sale, or other disposition of Shares to Homology (or effecting a “net exercise” of a Homology Option) as payment for the (i) exercise price of such Stockholder’s Homology Options and (ii) taxes applicable to the exercise of such Stockholder’s Homology Options, (3) if Stockholder is an entity, partnership or limited liability company, a transfer to one or more equityholders, partners or members of Stockholder or to an Affiliated person, corporation, trust or other Entity controlling or under common control with Stockholder, or if Stockholder is a trust, a transfer to a beneficiary, provided that in each such case the applicable transferee has signed a voting agreement in substantially the form hereof, (4) make transfers that occur by operation of law pursuant to a qualified domestic relations order or in connection with a divorce settlement, and (5) transfers, sales or other dispositions as the Company may otherwise agree in writing in its sole discretion. If any voluntary or involuntary transfer of any Shares covered hereby shall occur (including a transfer or disposition permitted by Section 4(1) through Section 4(5), sale by a Stockholder’s trustee in bankruptcy, or a sale to a purchaser at any creditor’s or court sale), the transferee (which term, as used herein, shall include any and all transferees and subsequent transferees of the initial transferee) shall take and hold such Shares subject to all of the restrictions, liabilities and rights under this Agreement, which shall continue in full force and effect, notwithstanding that such transferee is not a Stockholder and has not executed a counterpart hereof or joinder hereto.

5. Representations and Warranties of Stockholder. Each Stockholder hereby, severally but not jointly, represents and warrants to Homology and the Company as follows:

(a) If such Stockholder is an Entity: (i) such Stockholder is duly organized, validly existing and in good standing under the laws of the jurisdiction in which it is incorporated, organized or constituted, (ii) such Stockholder has all necessary power and authority to execute and deliver this Agreement, to perform such Stockholder’s obligations hereunder and to consummate the transactions contemplated hereby, and (iii) the execution and delivery of this Agreement, performance of such Stockholder’s obligations hereunder and the consummation of the transactions contemplated hereby by such Stockholder have been duly authorized by all necessary action on the part of such Stockholder and no other proceedings on the part of such Stockholder are necessary to authorize this Agreement, or to consummate the transactions contemplated hereby. If such Stockholder is an individual, such Stockholder has the legal capacity to execute and deliver this Agreement, to perform such Stockholder’s obligations hereunder and to consummate the transactions contemplated hereby;

 

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(b) this Agreement has been duly executed and delivered by or on behalf of such Stockholder and, to such Stockholder’s knowledge and assuming this Agreement constitutes a valid and binding agreement of the Company and Homology, constitutes a valid and binding agreement with respect to such Stockholder, enforceable against such Stockholder in accordance with its terms, except as enforcement may be limited by general principles of equity whether applied in a court of Law or a court of equity and by bankruptcy, insolvency and similar Laws affecting creditors’ rights and remedies generally;

(c) Stockholder has had the opportunity to review the Merger Agreement and this Agreement with counsel of Stockholder’s own choosing. Stockholder has had an opportunity to review with its own tax advisors the tax consequences of the Merger and the Contemplated Transactions. Stockholder understands that it must rely solely on its advisors and not on any statements or representations made by Homology, the Company or any of their respective agents or representatives. Stockholder understands that such Stockholder (and not Homology, the Company or the Surviving Corporation) shall be responsible for such Stockholder’s tax liability that may arise as a result of the Merger or the transactions contemplated by the Merger Agreement. Stockholder understands and acknowledges that the Company, Homology and Merger Sub are entering into the Merger Agreement in reliance upon Stockholder’s execution, delivery and performance of this Agreement.

(d) such Stockholder beneficially owns the number of Shares indicated opposite such Stockholder’s name on Schedule 1, which constitute all of the Shares owned by the Stockholder as of the date hereof. Such Stockholder will own any New Shares, free and clear of any liens, claims, charges or other encumbrances or restrictions of any kind whatsoever (“Liens”), and has sole or shared, and otherwise unrestricted, voting power with respect to such Shares or New Shares and none of the Shares or New Shares is subject to any voting trust or other agreement, arrangement or restriction with respect to the voting of the Shares or the New Shares, except as contemplated by this Agreement and the stockholder agreements and arrangements referenced in the Merger Agreement and except for customary arrangements with the Stockholder’s prime broker and/or custodian;

(e) to the knowledge of such Stockholder, the execution and delivery of this Agreement by such Stockholder does not, and the performance by such Stockholder of his, her or its obligations hereunder and the compliance by such Stockholder with any provisions hereof will not, violate or conflict with, result in a material breach of or constitute a default (or an event that with notice or lapse of time or both would become a material default) under, or give to others any rights of termination, amendment, acceleration or cancellation of, or result in the creation of any Liens on any Shares or New Shares pursuant to, any agreement, instrument, note, bond, mortgage, Contract, lease, license, permit or other obligation or any order, arbitration award, judgment or decree to which such Stockholder is a party or by which such Stockholder is bound, or any Law, statute, rule or regulation to which such Stockholder is subject or, in the event that such Stockholder is a corporation, partnership, trust or other Entity, any bylaw or other Organizational Document of such Stockholder; except for any of the foregoing as would not reasonably be expected to prevent or delay the performance by such Stockholder of his, her or its obligations under this Agreement in any material respect;

(f) the execution and delivery of this Agreement by such Stockholder does not, and the performance of this Agreement by such Stockholder does not and will not, require any consent, approval, authorization or permit of, or filing with or notification to, any Governmental Authority or regulatory authority by such Stockholder except for applicable requirements, if any, of the Exchange Act, and except where the failure to obtain such consents, approvals, authorizations or permits, or to make such filings or notifications, would not prevent or delay the performance by such Stockholder of his, her or its obligations under this Agreement in any material respect;

(g) no investment banker, broker, finder or other intermediary is entitled to a fee or commission from Homology or the Company in respect of this Agreement based upon any Contract made by or on behalf of such Stockholder; and

 

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(h) as of the date of this Agreement, there is no Legal Proceeding pending or, to the knowledge of such Stockholder, threatened against such Stockholder that would reasonably be expected to prevent or delay the performance by such Stockholder of his, her or its obligations under this Agreement in any material respect.

6. Irrevocable Proxy. Subject to the penultimate sentence of this Section 6, by execution of this Agreement, each Stockholder does hereby appoint the Company and any of its designees with full power of substitution and resubstitution, as such Stockholder’s true and lawful attorney and irrevocable proxy, to the fullest extent of such Stockholder’s rights with respect to the Shares, to vote and exercise all voting and related rights, including the right to sign such Stockholder’s name (solely in its capacity as a stockholder) to any Stockholder consent, if such Stockholder fails to vote his, her or its Shares solely with respect to the matters set forth in Section 1 hereof by 5:00 p.m. (Eastern Time) on the day immediately preceding the meeting date (or date upon which written consents are requested to be submitted), provided the Stockholder has received information regarding the meeting or request for written consent at least five (5) Business Days before such shareholder meeting or any consent solicitation or other vote taken of the Company’s stockholders. Each Stockholder intends this proxy to be irrevocable and coupled with an interest hereunder until the Expiration Date, hereby revokes any proxy previously granted by such Stockholder with respect to the Shares and represents that none of such previously-granted proxies are irrevocable. The Stockholder hereby affirms that the proxy set forth in this Section 6 is given in connection with, and granted in consideration of, and as an inducement to the Company, Homology and Merger Sub to enter into the Merger Agreement and that such proxy is given to secure the obligations of the Stockholder under Section 1. The irrevocable proxy and power of attorney granted herein shall survive the death or incapacity of such Stockholder and the obligations of such Stockholder shall be binding on such Stockholder’s heirs, personal representatives, successors, transferees and assigns. Each Stockholder hereby agrees not to grant any subsequent powers of attorney or proxies with respect to any Shares with respect to the matters set forth in Section 1 until after the Expiration Date. With respect to any Shares that are owned beneficially by Stockholder but are not held of record by Stockholder (other than shares beneficially owned by Stockholder that are held in the name of a bank, broker or nominee), Stockholder shall take all action necessary to cause the record holder of such Shares to grant the irrevocable proxy and take all other actions provided for in this Section 6 with respect to such Shares. Notwithstanding anything contained herein to the contrary, this irrevocable proxy shall automatically terminate upon the Expiration Date.

7. No Legal Actions. Each Stockholder will not in its capacity as a stockholder of Homology bring, commence, institute, maintain, prosecute or voluntarily aid any Legal Proceeding which (i) challenges the validity or seeks to enjoin the operation of any provision of this Agreement or (ii) alleges that the execution and delivery of this Agreement by such Stockholder, either alone or together with the other voting agreements and proxies to be delivered in connection with the execution of the Merger Agreement, or the approval of the Merger Agreement and the Contemplated Transactions by the Homology Board, constitutes a breach of any fiduciary duty of the Homology Board or any member thereof.

8. Other Remedies; Specific Performance. Except as otherwise provided herein, any and all remedies herein expressly conferred upon a party will be deemed cumulative with, and not exclusive of, any other remedy conferred hereby, or by Law or equity upon such party, and the exercise by a party of any one remedy will not preclude the exercise of any other remedy. The parties hereto agree that irreparable damage would occur in the event that any of the provisions of this Agreement were not performed in accordance with their specific terms or were otherwise breached. It is accordingly agreed that the parties shall be entitled to an injunction or injunctions to prevent breaches of this Agreement and to enforce specifically the terms and provisions hereof without the need of posting bond in any court of the United States or any state having jurisdiction, this being in addition to any other remedy to which they are entitled at Law or in equity.

9. Directors and Officers. This Agreement shall apply to each Stockholder solely in such Stockholder’s capacity as a stockholder of Homology and/or holder of Homology Options and not in such Stockholder’s capacity as a director, officer or employee of Homology or any of its Subsidiaries or in such Stockholder’s capacity as a trustee or fiduciary of any employee benefit plan or trust. Notwithstanding any provision of this

 

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Agreement to the contrary, nothing in this Agreement shall (or require Stockholder to attempt to) limit or restrict a director and/or officer of Homology in the exercise of his or her fiduciary duties consistent with the terms of the Merger Agreement as a director and/or officer of Homology or in his or her capacity as a trustee or fiduciary of any employee benefit plan or trust or prevent or be construed to create any obligation on the part of any director and/or officer of Homology or any trustee or fiduciary of any employee benefit plan or trust from taking any action in his or her capacity as such director, officer, trustee and/or fiduciary.

10. No Ownership Interest. Nothing contained in this Agreement shall be deemed to vest in the Company any direct or indirect ownership or incidence of ownership of or with respect to any Shares. All rights, ownership and economic benefits of and relating to the Shares shall remain vested in and belong to such Stockholder, and the Company does not have authority to manage, direct, superintend, restrict, regulate, govern, or administer any of the policies or operations of Homology or exercise any power or authority to direct such Stockholder in the voting of any of the Shares, except as otherwise provided herein.

11. Termination. This Agreement shall terminate and shall have no further force or effect as of the Expiration Date. Notwithstanding the foregoing, upon termination or expiration of this Agreement, no party shall have any further obligations or liabilities under this Agreement; provided, however, nothing set forth in this Section 11 or elsewhere in this Agreement shall relieve any party from liability for any fraud or for any willful and material breach of this Agreement prior to termination hereof.

12. Further Assurances. Each Stockholder shall, from time to time, execute and deliver, or cause to be executed and delivered, such additional or further consents, documents and other instruments as the Company or Homology may reasonably request for the purpose of effectively carrying out the transactions contemplated by this Agreement and the Contemplated Transactions.

13. Disclosure. Each Stockholder hereby agrees that Homology and the Company may publish and disclose in the Proxy Statement, any prospectus filed with any regulatory authority in connection with the Contemplated Transactions and any related documents filed with such regulatory authority and as otherwise required by Law, such Stockholder’s identity and ownership of Shares and the nature of such Stockholder’s commitments, arrangements and understandings under this Agreement and may further file this Agreement as an exhibit to the Proxy Statement or prospectus or in any other filing made by Homology or the Company as required by Law or the terms of the Merger Agreement, including with the SEC or other regulatory authority, relating to the Contemplated Transactions, all subject to prior review and a reasonable opportunity to comment by Stockholder’s counsel. Prior to the Closing, each Stockholder shall not, and shall use its reasonable best efforts to cause its representatives not to, directly or indirectly, make any press release, public announcement or other public communication regarding the Merger without the prior written consent of Homology and the Company, provided that the foregoing shall not limit or affect any actions taken by such Stockholder (or any affiliated officer or director of such Stockholder) that would be permitted to be taken by such Stockholder, Homology or the Company pursuant to the Merger Agreement; provided, further, that the foregoing shall not effect any actions of Stockholder the prohibition of which would be prohibited under applicable Law and shall not prohibit Stockholder or its affiliates from making any publicly-available filings required by applicable law, regulation or legal process.

14. Notice. All notices and other communications hereunder shall be in writing and shall be deemed given if delivered personally or sent by overnight courier (providing proof of delivery), by facsimile transmission (providing confirmation of transmission) or by electronic transmission (providing confirmation of transmission) to the Company or Homology, as the case may be, in accordance with Section 9.7 of the Merger Agreement and to each Stockholder at his, her or its address or email address (providing confirmation of transmission) set forth on Schedule 1 attached hereto (or at such other address for a party as shall be specified by like notice).

 

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15. Severability. Any term or provision of this Agreement that is invalid or unenforceable in any situation in any jurisdiction shall not affect the validity or enforceability of the remaining terms and provisions of this Agreement or the validity or enforceability of the offending term or provision in any other situation or in any other jurisdiction. If a final judgment of a court of competent jurisdiction declares that any term or provision of this Agreement is invalid or unenforceable, the parties hereto agree that the court making such determination shall have the power to limit such term or provision, to delete specific words or phrases or to replace such term or provision with a term or provision that is valid and enforceable and that comes closest to expressing the intention of the invalid or unenforceable term or provision, and this Agreement shall be valid and enforceable as so modified. In the event such court does not exercise the power granted to it in the prior sentence, the parties hereto agree to replace such invalid or unenforceable term or provision with a valid and enforceable term or provision that will achieve, to the extent possible, the economic, business and other purposes of such invalid or unenforceable term or provision.

16. Assignability. This Agreement shall be binding upon, and shall be enforceable by and inure solely to the benefit of, the parties hereto and their respective successors and assigns; provided, however, that neither this Agreement nor any of a party’s rights or obligations hereunder may be assigned or delegated by such party without the prior written consent of the other parties hereto, and any attempted assignment or delegation of this Agreement or any of such rights or obligations by such party without the other party’s prior written consent shall be void and of no effect. Nothing in this Agreement, express or implied, is intended to or shall confer upon any Person (other than the parties hereto) any right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.

17. No Waivers. No waivers of any breach of this Agreement extended by the Company or Homology to such Stockholder shall be construed as a waiver of any rights or remedies of the Company or Homology, as applicable, with respect to any other stockholder of Homology who has executed an agreement substantially in the form of this Agreement with respect to Shares held or subsequently held by such stockholder or with respect to any subsequent breach of Stockholder or any other such stockholder of Homology. No waiver of any provisions hereof by any party shall be deemed a waiver of any other provisions hereof by any such party, nor shall any such waiver be deemed a continuing waiver of any provision hereof by such party.

18. Applicable Law; Jurisdiction. This Agreement shall be governed by, and construed in accordance with, the Laws of the state of Delaware, regardless of the Laws that might otherwise govern under applicable principles of conflicts of Laws. In any action or Legal Proceeding between any of the parties arising out of or relating to this Agreement, each of the parties: (i) irrevocably and unconditionally consents and submits to the exclusive jurisdiction and venue of the Court of Chancery of the state of Delaware or to the extent such court does not have subject matter jurisdiction, the Superior Court of the State of Delaware or the United States District Court for the District of Delaware, (ii) agrees that all claims in respect of such action or Legal Proceeding shall be heard and determined exclusively in accordance with clause (i) of this Section 18, (iii) waives any objection to laying venue in any such action or Legal Proceeding in such courts, (iv) waives any objection that such courts are an inconvenient forum or do not have jurisdiction over any party, and (v) agrees that service of process upon such party in any such action or Legal Proceeding shall be effective if notice is given in accordance with Section 14 of this Agreement. Each party irrevocably consents to service of process inside or outside the territorial jurisdiction of the courts referred to in this Section 18 in the manner provided for notices in Section 14. Nothing in this Agreement will affect the right of any party to serve process in any other manner permitted by applicable Law.

19. Waiver of Jury Trial. The parties hereto hereby waive any right to trial by jury with respect to any action or Legal Proceeding related to or arising out of this Agreement, any document executed in connection herewith and the matters contemplated hereby and thereby.

20. No Agreement Until Executed. Irrespective of negotiations among the parties or the exchanging of drafts of this Agreement, this Agreement shall not constitute or be deemed to evidence a Contract, agreement, arrangement or understanding between the parties hereto unless and until (a) the Homology Board has approved,

 

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for purposes of any applicable anti-takeover Laws and regulations and any applicable provision of the certificate of incorporation of Homology, the Merger Agreement and the Contemplated Transactions, (b) the Merger Agreement is executed by all parties thereto, and (c) this Agreement is executed by all parties hereto.

21. Entire Agreement; Counterparts; Exchanges by Electronic Transmission. This Agreement and the other agreements referred to in this Agreement constitute the entire agreement and supersede all prior agreements and understandings, both written and oral, among or between any of the parties with respect to the subject matter hereof and thereof. This Agreement may be executed in several counterparts, each of which shall be deemed an original and all of which shall constitute one and the same instrument. The exchange of a fully executed Agreement (in counterparts or otherwise) by all parties by facsimile or electronic transmission via “.pdf” shall be sufficient to bind the parties to the terms and conditions of this Agreement.

22. Amendment. This Agreement may not be amended, supplemented or modified, and no provisions hereof may be modified or waived, except by an instrument in writing signed on behalf of each party hereto; provided, however, that the rights or obligations of any Stockholder may be waived, amended or otherwise modified in a writing signed by Homology, the Company and such Stockholder.

23. Fees and Expenses. Except as otherwise specifically provided herein, the Merger Agreement or any other agreement contemplated by the Merger Agreement to which a party hereto is a party, each party hereto shall bear its own expenses in connection with this Agreement and the transactions contemplated hereby.

24. Voluntary Execution of Agreement. This Agreement is executed voluntarily and without any duress or undue influence on the part or behalf of the parties. Each of the parties hereby acknowledges, represents and warrants that (i) it has read and fully understood the Merger Agreement, this Agreement and the implications and consequences thereof; (ii) it has been represented in the preparation, negotiation, and execution of this Agreement by legal counsel of its own choice, or it has made a voluntary and informed decision to decline to seek such counsel; and (iii) it is fully aware of the legal and binding effect of this Agreement.

25. Definition of Merger Agreement. For purposes of this Agreement, the term “Merger Agreement” may include such agreement as amended or modified as long as such amendments or modifications (a) do not (i) change the form or amount of consideration payable under the Merger Agreement, (ii) extend the Outside Date past May 16, 2024 (other than any extension provided for in Section 8.1(b) of the Merger Agreement with respect to the Registration Statement), or (iii) otherwise change the terms and conditions of the Merger, the Concurrent Financing or the other Contemplated Transaction in a manner materially adverse to such Stockholder or (b) have been agreed to in writing by such Stockholder.

26. Construction.

(a) For purposes of this Agreement, whenever the context requires: the singular number shall include the plural, and vice versa; the masculine gender shall include the feminine and neuter genders; the feminine gender shall include the masculine and neuter genders; and the neuter gender shall include masculine and feminine genders.

(b) The parties hereto agree that any rule of construction to the effect that ambiguities are to be resolved against the drafting party shall not be applied in the construction or interpretation of this Agreement.

(c) As used in this Agreement, the words “include” and “including,” and variations thereof, shall not be deemed to be terms of limitation, but rather shall be deemed to be followed by the words “without limitation.”

(d) Except as otherwise indicated, all references in this Agreement to “Sections,” and “Schedules” are intended to refer to Sections of this Agreement and Schedules to this Agreement, respectively.

 

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(e) The underlined headings contained in this Agreement are for convenience of reference only, shall not be deemed to be a part of this Agreement and shall not be referred to in connection with the construction or interpretation of this Agreement.

[Remainder of Page has Intentionally Been Left Blank]

 

 

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EXECUTED as of the date first above written.
    [STOCKHOLDER]
    Signature:                                                                 

[Signature Page to Homology Stockholder Support Agreement]


EXECUTED as of the date first above written.

 

HOMOLOGY MEDICINES, INC.
By:  

 

Name:
Title:
Q32 BIO INC.
By:  

 

Name:
Title:

[Signature Page to Homology Stockholder Support Agreement]


SCHEDULE 1

[Intentionally Omitted]

Exhibit 10.5

CONTINGENT VALUE RIGHTS AGREEMENT

BETWEEN

HOMOLOGY MEDICINES, INC.

and

EQUINITI TRUST COMPANY, LLC, as Rights Agent

Dated as of [*]


TABLE OF CONTENTS

 

         Page  

ARTICLE 1 DEFINITIONS

     1  

Section 1.1

  Definitions      1  

ARTICLE 2 CONTINGENT VALUE RIGHTS

     4  

Section 2.1

  Holders of CVRs; Appointment of Rights Agent      4  

Section 2.2

  Non-transferable      4  

Section 2.3

  No Certificate; Registration; Registration of Transfer; Change of Address      4  

Section 2.4

  Payment Procedures      5  

Section 2.5

  No Voting, Dividends or Interest; No Equity or Ownership Interest      6  

Section 2.6

  Ability to Abandon CVR      7  

ARTICLE 3 THE RIGHTS AGENT

     7  

Section 3.1

  Certain Duties and Responsibilities      7  

Section 3.2

  Certain Rights of Rights Agent      7  

Section 3.3

  Resignation and Removal; Appointment of Successor      9  

Section 3.4

  Acceptance of Appointment by Successor      10  

ARTICLE 4 COVENANTS

     10  

Section 4.1

  List of Holders      10  

Section 4.2

  CVR Committee; Efforts      10  

Section 4.3

  Prohibited Actions      12  

ARTICLE 5 AMENDMENTS

     12  

Section 5.1

  Amendments Without Consent of Holders or Rights Agent      12  

Section 5.2

  Amendments with Consent of Holders      13  

Section 5.3

  Effect of Amendments      13  

ARTICLE 6 CONSOLIDATION, MERGER, SALE OR CONVEYANCE

     13  

Section 6.1

  Homology May Not Consolidate, Etc.      13  

Section 6.2

  Successor Substituted      13  

ARTICLE 7 MISCELLANEOUS

     14  

Section 7.1

  Notices to Rights Agent and to Homology      14  

Section 7.2

  Notice to Holders      14  

Section 7.3

  Entire Agreement      14  

Section 7.4

  Merger or Consolidation or Change of Name of Rights Agent      15  

Section 7.5

  Successors and Assigns      15  

Section 7.6

  Benefits of Agreement; Action by Majority of Holders      15  

Section 7.7

  Governing Law      15  

Section 7.8

  Jurisdiction      15  

Section 7.9

  WAIVER OF JURY TRIAL      16  

Section 7.10

  Severability Clause      16  

Section 7.11

  Counterparts; Effectiveness      16  

Section 7.12

  Termination      16  

Section 7.13

  Force Majeure      17  

Section 7.14

  Construction      17  

 

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FORM OF

CONTINGENT VALUE RIGHTS AGREEMENT

THIS CONTINGENT VALUE RIGHTS AGREEMENT (this “Agreement”), dated as of [*], is entered into by and between Homology Medicines, Inc., a Delaware corporation (“Homology”), and Equiniti Trust Company, LLC, a New York limited liability company (“EQ”), as initial Rights Agent (as defined herein).

PREAMBLE

WHEREAS, Homology, Kenobi Merger Sub, Inc., a Delaware corporation and wholly-owned subsidiary of Homology (“Merger Sub”), and Q32 Bio Inc., a Delaware corporation (the “Company”), have entered into an Agreement and Plan of Merger, dated as of November 16, 2023 (the “Merger Agreement”), pursuant to which Merger Sub will merge with and into the Company (the “Merger”), with the Company surviving the Merger as a wholly-owned subsidiary of Homology (the “Surviving Corporation”);

WHEREAS, in connection with the Merger Agreement, Homology has agreed to provide to the Holders (as defined herein) contingent value rights as hereinafter described;

WHEREAS, the parties have done all things necessary to make the contingent value rights, when issued pursuant to this Agreement, the valid obligations of Homology and to make this Agreement a valid and binding agreement of Homology, in accordance with its terms; and

NOW, THEREFORE, in consideration of the premises and the consummation of the transactions referred to above, it is mutually covenanted and agreed, for the proportionate benefit of all Holders, as follows:

ARTICLE 1

DEFINITIONS

Section 1.1 Definitions.

Capitalized terms used but not otherwise defined herein have the meanings ascribed thereto in the Merger Agreement. The following terms have the meanings ascribed to them as follows:

“Business Day” means any day other than a day on which banks in the State of New York are authorized or obligated to be closed.

“Closing” means the closing of the Merger.

“Closing Date” means the date on which the Closing actually takes place.

“Commercially Reasonable Efforts” means with respect to the disposition of the Legacy Assets, carrying out those obligations and tasks in a good faith and diligent manner, including the fact that, following the Merger, the Legacy Assets are not part of Homology’s go-forward business plan, taking into account all commercial and other relevant factors that Homology, exercising good faith, would normally take into account with a disposition of non-core assets, provided that, notwithstanding the foregoing, such level of efforts and resources shall not require Homology to (i) hire or retain any business development personnel or third-party financial advisors specifically for the purpose of the Legacy Asset Disposition, or (ii) initiate any bona fide sale process or other pro-active efforts to identify potential counterparties with respect to any Legacy Assets, and provided, further,

 

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that such level of efforts and resources shall be determined without taking into account the CVR Payment payable in accordance with, and subject to, the terms hereof.

“CVR” means a contingent contractual right of Holders to receive CVR Payments under this Agreement.

“CVR Payment” means the CVR Proceeds for a given payment.

“CVR Period” means the period beginning immediately following the Effective Time and ending on the tenth anniversary of the Closing Date.

“CVR Proceeds” means, upon the consummation of any Legacy Asset Disposition following the Closing Date and prior to expiration of the Disposition Period or, if applicable, the fiscal quarter during the CVR Period in which the proceeds of any Legacy Asset Disposition are received, the amount of Gross Proceeds actually received by Homology or any of its Subsidiaries upon such consummation or during the applicable fiscal quarter, less Permitted Deductions with respect to such Gross Proceeds, in each case as calculated in accordance with GAAP consistently applied.

“Disposition Period” means the period beginning on the execution date of the Merger Agreement and ending on the 18 month anniversary of the Closing Date; provided, that, for any sale, transfer, license, assignment, or other divestiture, disposition or commercialization of any Oxford Assets, the Disposition Period means the period beginning on the execution date of the Merger Agreement and ending on the 24 month anniversary of the Closing Date solely with respect to such Oxford Assets.

“Effective Time” means the time at which the Merger shall become effective at the time of the filing of the Certificate of Merger and the acceptance by the Secretary of State of the State of Delaware, or at such later time as may be specified in such Certificate of Merger with the consent of Homology and the Company.

“Expense Reserve” means $[•]1.

“Gross Proceeds” means, without duplication, all cash consideration that is paid to, or is received by, Homology or any of its Subsidiaries during the CVR Period in consideration for a Legacy Asset Disposition.

“Holder” means, at the relevant time, a Person in whose name CVRs are registered in the CVR Register.

“Majority of Holders” means, at any time, the registered Holder or Holders of more than 50% of the total number of CVRs registered at such time, as set forth on the CVR Register.

“Legacy Assets” means the assets, rights and interests held by or on behalf of Homology or any of its Subsidiaries as of the execution date of the Merger Agreement relating to Homology’s HMI-103 (Adult/Pediatric PKU), HMI-204 (MLD), Capsids and AAVHSC Platform, including any equity interests held directly or indirectly by Homology in Oxford Biomedica Solutions, LLC or its affiliates (“OXB Solutions”) pursuant to that certain Equity Securities Purchase Agreement, dated as of January 28, 2022, by and between Homology and OXB Solutions, in which Homology owns twenty percent (20%) of the fully diluted equity interests in OXB Solutions and Homology is entitled to exercise a put option to sell or transfer Homology’s equity interests in OXB Solutions set forth therein on March 10, 2025 (such interests, the “Oxford Assets”); provided that Legacy Assets shall not include any Abandoned Homology Legacy IP Rights (as defined in the Merger Agreement).

“Legacy Asset Disposition” means the sale, transfer, license, assignment or other divestiture, disposition or commercialization of any Legacy Assets (including any such sale or disposition of equity securities in any

 

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Note to Draft: In connection with execution of the CVR Agreement at Closing, to insert the dollar amount actually deducted from Net Cash to cover expenses related to maintenance and disposition of Legacy Assets during the Disposition Period, which amount shall not exceed $400,000 in the aggregate.

 

2


Subsidiary that was established by Homology during the Disposition Period solely to hold any right, title or interest in or to all or any Legacy Assets) in a transaction or series of transactions, in each case entered into during the Disposition Period.

“Officer’s Certificate” means a certificate signed by the chief executive officer or the chief financial officer of Homology, in their respective official capacities.

“Permitted Deductions” means the following costs or expenses, without duplication:

 

  (i)

any applicable and non-recoverable value added, sales or similar Taxes imposed on the Gross Proceeds and payable in cash by Homology or any of its Subsidiaries and any income Taxes required to be paid in cash by Homology or any of its Subsidiaries, in each case, with respect to the taxable year in which such Gross Proceeds were received which Taxes would not have been required to be paid by Homology or its applicable Subsidiary but for its receipt of Gross Proceeds; provided, that, for purposes of calculating any income Taxes of Homology or any of its Subsidiaries for this purpose, (a) such income Taxes shall be computed after taking into account any net operating loss carryforwards or other Tax attributes (including Tax credits) of Homology or any of its Subsidiaries that are available to offset income or gain, after taking into account any limits of the usability of such attributes under applicable Law, including under Section 382 of the Code, as reasonably determined by a nationally recognized tax advisor, which Tax attributes were generated either (I) prior to the Closing Date or (II) after the Closing Date, in the case of this clause (II) if such Tax attributes relate to the Legacy Assets, and (b) for the avoidance of doubt, any item(s) of income or gain resulting or arising from such Gross Proceeds shall be treated as the first item(s) of income or gain, as applicable, in the applicable taxable year;

 

  (ii)

any documented out-of-pocket costs and expenses incurred or accrued by Homology or any of its Subsidiaries in respect of its performance of this Agreement following the Closing Date or in respect of its negotiation, execution, delivery or performance of any agreement in connection with the Legacy Assets (for clarity, including any Sale Agreement), including (i) any costs related to the prosecution, maintenance or enforcement by Homology or any of its Subsidiaries of intellectual property rights (but excluding any costs related to a breach of this Agreement by Homology, including costs incurred in litigation in respect of the same), (ii) any costs related to Liabilities of or relating to the Legacy Assets that remain with Homology following the consummation of any Legacy Asset Disposition or (iii) any documented out-of-pocket fees of the Rights Agent in connection with this Agreement;

 

  (iii)

any documented out-of-pocket costs incurred or accrued by Homology or any of its Subsidiaries in connection with the negotiation, entry into and closing of any Legacy Asset Disposition, including any brokerage fee, finder’s fee, opinion fee, success fee, transaction fee, service fee, regulatory and other filing fees, or other fee, commission or expense owed to any broker, finder, investment bank, auditor, accountant, counsel, advisor or other third party in relation thereto;

 

  (iv)

any Losses incurred and paid or payable by Homology or any of its Subsidiaries arising out of any third party claims, demands, actions or other proceedings relating to or in connection with any Legacy Assets or any Legacy Asset Disposition, including in respect of its performance of this Agreement, any Sale Agreement or any other agreement relating to any Legacy Asset Disposition and, notwithstanding anything in this Agreement to the contrary, the maximum amount that could be payable under any obligations of Homology or any of its Subsidiaries (including contingent or indemnification obligations provided for, arising out of or in connection with any Sale Agreement or any other agreement relating to any Legacy Asset Disposition); provided that any amounts deducted in respect of contingent or indemnification obligations shall be held back by Homology in a separate account for the benefit of the Holders and to the extent such amounts have not been used to pay such contingent or indemnification obligations upon the lapse in survival of the such contingent or indemnification obligations (or, if applicable, until any dispute related to such provisions is finally resolved if such resolution occurs subsequent to such lapse) prior to the end of the CVR Period, shall be paid over to the Rights Agent within five (5) Business days of such lapse; and

 

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  (v)

any liabilities borne by Homology or any of its Subsidiaries pursuant to contracts related to the Legacy Assets, including costs arising from the termination thereof (in each case only to the extent not included in the calculation of Homology Net Cash (as defined in the Merger Agreement)).

“Permitted Transfer” means a Transfer of one or more CVRs (i) upon death of a Holder by will or intestacy; (ii) by instrument to an inter vivos or testamentary trust in which the CVRs are to be passed to beneficiaries upon the death of the trustee; (iii) made pursuant to a court order of a court of competent jurisdiction (such as in connection with divorce, bankruptcy or liquidation); (iv) made by operation of law (including a consolidation or merger) or without consideration in connection with the dissolution, liquidation or termination of any corporation, limited liability company, partnership or other entity; (v) in the case of CVRs payable to a nominee, from a nominee to a beneficial owner (and, if applicable, through an intermediary) or from such nominee to another nominee for the same beneficial owner, in each case as permitted by The Depository Trust Company; (vi) to Homology or its Subsidiaries; or (vii) as provided in Section 2.6.

“Person” means any individual, partnership, joint venture, limited liability company, firm, corporation, unincorporated association or organization, trust or other entity, and shall include any successor (by merger or otherwise) of any such Person.

“Record Date” means the close of business on the last Business Day prior to the day on which the Effective Time occurs.

“Rights Agent” means the Rights Agent named in the first paragraph of this Agreement, until a successor Rights Agent shall have been appointed pursuant to Article 3 of this Agreement, and thereafter “Rights Agent” will mean such successor Rights Agent.

“Transfer” means transfer, pledge, hypothecation, encumbrance, assignment or other disposition (whether by sale, merger, consolidation, liquidation, dissolution, dividend, distribution or otherwise), the offer to make such a transfer or other disposition, and each contract, arrangement or understanding, whether or not in writing, to effect any of the foregoing.

ARTICLE 2

CONTINGENT VALUE RIGHTS

Section 2.1 Holders of CVRs; Appointment of Rights Agent.

 

(a)

The CVRs shall be issued to the holders of shares of Homology Common Stock as of the Record Date.

 

(b)

Homology hereby appoints the Rights Agent to act as rights agent for Homology in accordance with the express terms and conditions set forth in this Agreement, and the Rights Agent hereby accepts such appointment.

Section 2.2 Non-transferable.

A Holder may not at any time Transfer CVRs, other than pursuant to a Permitted Transfer. Any attempted Transfer that is not a Permitted Transfer, in whole or in part, will be void ab initio and of no effect. The CVRs will not be listed on any quotation system or traded on any securities exchange.

Section 2.3 No Certificate; Registration; Registration of Transfer; Change of Address.

 

(a)

Holders’ rights and obligations in respect of CVRs derive solely from this Agreement; CVRs will not be evidenced by a certificate or other instrument.

(b)

The Rights Agent will maintain an up-to-date register (the “CVR Register”) for the purposes of (i) identifying the Holders of CVRs, (ii) determining Holders’ entitlement to CVRs and (iii) registering the

 

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  CVRs and Permitted Transfers thereof. The CVR Register will initially show one position for The Depository Trust Company (or its nominee) representing all of the CVRs provided to the holders of shares of Homology Common Stock held as of the Record Date. Except as expressly provided herein with respect to the rights of the Rights Agent, neither Homology nor its Subsidiaries will have any responsibility or liability whatsoever to any person other than the Holders.

 

(c)

Subject to the restriction on transferability set forth in Section 2.2, every request made to Transfer CVRs must be in writing and accompanied by a written instrument of Transfer reasonably acceptable to the Rights Agent, together with the signature guarantee of a guarantor institution which is a participant in a signature guarantee program approved by the Securities Transfer Association (a “signature guarantee”) and other requested documentation in a form reasonably satisfactory to the Rights Agent, duly executed and properly completed, as applicable, by the Holder or Holders thereof, or by the duly appointed legal representative, personal representative or survivor of such Holder or Holders, setting forth in reasonable detail the circumstances relating to the Transfer. Upon receipt of such written notice, the Rights Agent will, subject to its reasonable determination in accordance with its own internal procedures that the Transfer instrument is in proper form and the Transfer is a Permitted Transfer and otherwise complies on its face with the other terms and conditions of this Agreement, register the Transfer of the applicable CVRs in the CVR Register. All Transfers of CVRs registered in the CVR Register will be the valid obligations of Homology, evidencing the same right, and entitling the transferee to the same benefits and rights under this Agreement, as those held by the transferor. Each of Homology and the Rights Agent may require payment (without duplication) of a sum sufficient to cover any stamp or other transfer Tax or governmental charge that is imposed in connection with (and would not have been imposed but for) any such registration of transfer, unless the transferee shall have established to the reasonable satisfaction of Homology or the Rights Agent, as applicable, that such Tax, if any, has been paid. No transfer of CVRs shall be valid until registered in the CVR Register and any transfer not duly registered in the CVR Register shall be void. Homology shall not be responsible for any costs and expenses related to any transfer or assignment of the CVRs (including the cost of any transfer tax).

 

(d)

A Holder may make a written request to the Rights Agent to change such Holder’s address of record in the CVR Register. Such written request must be duly executed by such Holder. Upon receipt of such written notice, the Rights Agent shall promptly record the change of address in the CVR Register.

Section 2.4 Payment Procedures.

 

(a)

As promptly as practicable (and, in any event, within twenty (20) days) after the consummation of any Legacy Asset Dispositions and, in any event, not later than the date that is forty-five (45) days following the end of each fiscal quarter of Homology following the Closing in which CVR Proceeds are actually received by Homology or any of its Subsidiaries, Homology shall (i) deliver to the Rights Agent, an Officer’s Certificate certifying the aggregate amount of (A) the CVR Proceeds (if any) actually received by Homology or its Subsidiaries during such fiscal quarter (or, in the case of the first delivery of such an Officer’s Certificate hereunder, all CVR Proceeds actually received through the end of such fiscal quarter); (B) the Permitted Deductions reflected in such CVR Proceeds; and (C) the CVR Payment payable to Holders, if any, in respect of such CVR Proceeds, and (ii) deliver to the Rights Agent, or as the Rights Agent directs, the CVR Payment (if any) by wire transfer of immediately available funds to an account designated in writing by the Rights Agent. Upon receipt of the wire transfer referred to in the foregoing sentence, the Rights Agent shall promptly (and in any event, within ten (10) Business Days) pay, by check mailed, first-class postage prepaid, to the address of each Holder set forth in the CVR Register at such time or by other method of delivery as specified by the applicable Holder in writing to the Rights Agent, an amount equal to the product determined by multiplying (i) the quotient determined by dividing (A) the applicable CVR Payment by (B) the total number of CVRs registered in the CVR Register at such time, by (ii) the number of CVRs registered to such Holder in the CVR Register at such time. For the avoidance of doubt Homology shall have no further liability in respect of the relevant CVR Payment upon delivery of such CVR Payment in accordance with this Section 2.4(a) and the satisfaction of each of Homology’s obligations set forth in this Section 2.4(a).

 

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(b)

Except to the extent otherwise required pursuant to a change in applicable Law after the date hereof, the parties hereto agree to treat the issuance of the CVRs as not constituting a current distribution and all CVR Payments for U.S. federal (and applicable state and local) income Tax purposes as distributions of money governed by Section 301 of the U.S. Internal Revenue Code of 1986, as amended (the “Code”), which will constitute a dividend to the extent payable out of Homology and its Subsidiaries’ current and accumulated “earnings and profits” (pursuant to Section 316 of the Code) in the taxable year in which any such CVR Payment is made. The parties hereto will not take any position to the contrary on any Tax Return or for other Tax purposes except as required by a change in applicable Law after the date hereof.

 

(c)

Homology and the Rights Agent will be entitled to deduct and withhold, or cause to be deducted and withheld, from any CVR Payment otherwise payable pursuant to this Agreement, such amounts as it is required to deduct and withhold with respect to the making of such payment under any provision of applicable Law relating to Taxes. To the extent that amounts are so deducted and withheld and paid over to the appropriate Governmental Authority, such deducted and withheld amounts will be treated for all purposes of this Agreement as having been paid to the Holder in respect of which such deduction and withholding was made. Prior to making any such deductions or withholdings or causing any such deductions or withholdings to be made with respect to any Holder, the Rights Agent will, to the extent reasonably practicable, provide notice to the Holder of such potential Tax deduction or withholding and a reasonable opportunity for the Holder to provide any necessary Tax forms in order to avoid or reduce such withholding amounts; provided that the time period for payment of a CVR Payment by the Rights Agent set forth in Section 2.4(a) will be extended by a period equal to any delay caused by the Holder providing such forms; provided, further, that in no event shall such period be extended for more than ten (10) Business Days, unless otherwise requested by the Holder for the purpose of delivering such forms and agreed to by the Rights Agent.

 

(d)

Any portion of a CVR Payment that remains undistributed to the Holders six (6) months after the applicable fiscal quarter end (including by means of uncashed checks or invalid addresses on the CVR Register) will be delivered by the Rights Agent to Homology or a person nominated in writing by Homology (with written notice thereof from Homology to the Rights Agent), and any Holder will thereafter look only to Homology for payment of such CVR Payment (which shall be without interest).

 

(e)

Neither Homology nor the Rights Agent will be liable to any Person in respect of any CVR Payment amount delivered to a public official pursuant to any applicable abandoned property, escheat or similar legal requirement under applicable law. In addition to and not in limitation of any other indemnity obligation herein, Homology agrees to indemnify and hold harmless the Rights Agent with respect to any liability, penalty, cost or expense the Rights Agent may incur or be subject to in connection with transferring such property to Homology or a public official.

Section 2.5 No Voting, Dividends or Interest; No Equity or Ownership Interest.

 

(a)

CVRs will not have any voting or dividend rights, and interest will not accrue on any amounts payable in respect of CVRs.

 

(b)

CVRs will not represent any equity or ownership interest in Homology or any of its Subsidiaries or in the Surviving Corporation. The sole right of the Holders to receive property hereunder is the right to receive CVR Payments, if any, in accordance with the terms hereof. It is hereby acknowledged and agreed that a CVR shall not constitute a security of Homology or any of its Subsidiaries or of the Surviving Corporation.

 

(c)

It is hereby acknowledged and agreed that the CVRs and the possibility of any payment hereunder with respect thereto are highly speculative and subject to numerous factors outside of Homology’s control, and there is no assurance that Holders will receive any payments under this Agreement or in connection with the CVRs. Each Holder acknowledges that it is highly possible that there will not be any Gross Proceeds that may be the subject of a CVR Payment Amount. It is further acknowledged and agreed that neither Homology nor its Subsidiaries owe, by virtue of their obligations under this Agreement, a fiduciary duty or any implied duties to the Holders and the parties hereto intend solely the express provisions of this

 

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  Agreement to govern their contractual relationship with respect to the CVRs. It is acknowledged and agreed that this Section 2.5(c) is an essential and material term of this Agreement.

Section 2.6 Ability to Abandon CVR.

A Holder may at any time, at such Holder’s option, abandon all of such Holder’s remaining rights represented by CVRs by transferring such CVR to Homology or a person nominated in writing by Homology (with written notice thereof from Homology to the Rights Agent) without consideration or compensation therefor, and such rights will be cancelled, with the Rights Agent being promptly notified in writing by Homology of such transfer and cancellation. Nothing in this Agreement is intended to prohibit Homology or its Subsidiaries from offering to acquire or acquiring CVRs, in private transactions or otherwise, for consideration in its sole discretion.

ARTICLE 3

THE RIGHTS AGENT

Section 3.1 Certain Duties and Responsibilities.

 

(a)

The Rights Agent will not have any liability for any actions taken or not taken in connection with this Agreement, except to the extent such liability arises as a result of the willful misconduct, bad faith or gross negligence of the Rights Agent (in each case as determined by a final non-appealable judgment of court of competent jurisdiction). Notwithstanding anything in this Agreement to the contrary, any liability of the Rights Agent under this Agreement will be limited to the amount of annual fees paid by Homology to the Rights Agent during the twelve (12) months immediately preceding the event for which recovery from the Rights Agent is being sought, except in the case of the willful misconduct, bad faith or fraud of the Rights Agent (in each case as determined by a final non-appealable judgment of court of competent jurisdiction). Anything to the contrary notwithstanding, in no event will the Rights Agent be liable for special, punitive, indirect, incidental or consequential loss or damages of any kind whatsoever (including, without limitation, lost profits), even if the Rights Agent has been advised of the likelihood of such loss or damages, and regardless of the form of action.

 

(b)

The Rights Agent shall not have any duty or responsibility in the case of the receipt of any written demand from any Holder with respect to any action or default by any person or entity, including, without limiting the generality of the foregoing, any duty or responsibility to initiate or attempt to initiate any proceedings at law or otherwise or to make any demand upon Homology or the Company.

Section 3.2 Certain Rights of Rights Agent.

 

(a)

The Rights Agent undertakes to perform such duties and only such duties as are specifically set forth in this Agreement, and no implied covenants or obligations will be read into this Agreement against the Rights Agent.

 

(b)

The Rights Agent may rely and will be protected by Homology in acting or refraining from acting upon any resolution, certificate, statement, instrument, opinion, report, notice, request, direction, consent, order or other paper or document reasonably believed by it in the absence of bad faith to be genuine and to have been signed or presented by or on behalf of Homology.

 

(c)

The Rights Agent may engage and consult with counsel of its selection, and the advice or opinion of such counsel will, in the absence of bad faith, gross negligence or willful misconduct (in each case, as determined by a final, non-appealable judgment of a court of competent jurisdiction) on the part of the Rights Agent, be full and complete authorization and protection in respect of any action taken or not taken by the Rights Agent in reliance thereon.

 

(d)

Any permissive rights of the Rights Agent hereunder will not be construed as a duty.

 

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(e)

The Rights Agent will not be required to give any note or surety in respect of the execution of its powers or otherwise under this Agreement.

 

(f)

Homology agrees to indemnify the Rights Agent for, and to hold the Rights Agent harmless from and against, any loss, liability, damage, judgment, fine, penalty, cost or expense (each, a “Loss”) suffered or incurred by the Rights Agent and arising out of or in connection with the Rights Agent’s performance of its obligations under this Agreement, including the reasonable and documented costs and expenses of defending the Rights Agent against any claims, charges, demands, actions or suits arising out of or in connection in connection with the execution, acceptance, administration, exercise and performance of its duties under this Agreement, including the costs and expenses of defending against any claim of liability arising therefrom, directly or indirectly, or enforcing its rights hereunder, except to the extent such Loss has been determined by a final non-appealable decision of a court of competent jurisdiction to have resulted from the Rights Agent’s gross negligence, bad faith or willful misconduct (in each case, as determined by a final, non-appealable judgment of a court of competent jurisdiction).

 

(g)

In addition to the indemnification provided under Section 3.2(e), Homology agrees (i) to pay the fees of the Rights Agent in connection with the Rights Agent’s performance of its obligations hereunder, as agreed upon in writing by the Rights Agent and Homology on or prior to the date of this Agreement, and (ii) to reimburse the Rights Agent for all reasonable and documented out-of-pocket expenses and other disbursements incurred in the preparation, delivery, negotiation, amendment, administration and execution of this Agreement and the exercise and performance of its duties hereunder, including all taxes (other than income, receipt, franchise or similar taxes) and governmental charges, incurred by the Rights Agent in the performance of its obligations under this Agreement, except that Homology will have no obligation to pay the fees of the Rights Agent or reimburse the Rights Agent for the fees of counsel in connection with any lawsuit initiated by the Rights Agent on behalf of itself or the Holders, except in the case of any suit enforcing the provisions of Section 2.4(a), Section 2.4(b) or Section 3.2(e), if Homology is found by a court of competent jurisdiction to be liable to the Rights Agent or the Holders, as applicable in such suit.

 

(h)

No provision of this Agreement shall require the Rights Agent to expend or risk its own funds or otherwise incur any financial liability in the performance of any of its duties hereunder or in the exercise of any of its rights or powers if it believes that repayment of such funds or adequate indemnification against such risk or liability is not reasonably assured to it.

 

(i)

The Rights Agent will not be deemed to have knowledge of any event of which it was supposed to receive notice hereunder but has not received written notice of such event, and the Rights Agent will not incur any liability for failing to take action in connection therewith, in each case, unless and until it has received such notice in writing.

 

(j)

The Rights Agent may execute and exercise any of the rights or powers hereby vested in it or perform any duty hereunder either itself or by or through its attorney or agents and the Rights Agent shall not be answerable or accountable for any act, default, neglect or misconduct of any such attorney or agents or for any loss to Homology or the Company resulting from any such act, default, neglect or misconduct, absent gross negligence, bad faith or willful misconduct (each as determined by a final non-appealable judgment of a court of competent jurisdiction) in the selection and continued employment thereof.

 

(k)

Homology shall perform, acknowledge and deliver or cause to be performed, acknowledged and delivered all such further and other acts, documents, instruments and assurances as may be reasonably required by the Rights Agent for the carrying out or performing by the Rights Agent of the provisions of this Agreement.

 

(l)

The Rights Agent shall not be liable for or by reason of any of the statements of fact or recitals contained in this Agreement (except its countersignature thereof) or be required to verify the same, and all such statements and recitals are and shall be deemed to have been made by Homology only.

 

(m)

The Rights Agent shall act hereunder solely as agent for Homology and shall not assume any obligations or relationship of agency or trust with any of the owners or holders of the CVRs. The Rights Agent shall not have any duty or responsibility in the case of the receipt of any written demand from any Holders with

 

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  respect to any action or default by Homology, including, without limiting the generality of the foregoing, any duty or responsibility to initiate or attempt to initiate any proceedings at law or otherwise or to make any demand upon Homology.

 

(n)

The Rights Agent may rely on and be fully authorized and protected in acting or failing to act upon (i) any guaranty of signature by an “eligible guarantor institution” that is a member or participant in the Securities Transfer Agents Medallion Program or other comparable “signature guarantee program” or insurance program in addition to, or in substitution for, the foregoing; or (ii) any law, act, regulation or any interpretation of the same even though such law, act, or regulation may thereafter have been altered, changed, amended or repealed.

 

(o)

The Rights Agent shall not be liable or responsible for any failure of Homology to comply with any of its obligations relating to any registration statement filed with the Securities and Exchange Commission or this Agreement, including without limitation obligations under applicable Law.

 

(p)

Whenever the Rights Agent deems it desirable that a matter be proved or established prior to taking or omitting any action hereunder, the Rights Agent may (i) rely upon an Officer’s Certificate and (ii) incur no liability and be held harmless by the Company for or in respect of any action taken or omitted to be taken by it under the provisions of this Agreement in reliance upon such Officer’s Certificate.

 

(q)

All funds received by EQ under this Agreement that are to be distributed or applied by EQ in the performance of services hereunder (the “Funds”) shall be held by EQ as agent for Homology and deposited in one or more bank accounts to be maintained by EQ in its name as agent for Homology. Until paid pursuant to the terms of this Agreement, EQ will hold the Funds through such accounts in: deposit accounts of commercial banks with Tier 1 capital exceeding $1 billion or with an average rating above investment grade by S&P (LT Local Issuer Credit Rating), Moody’s (Long Term Rating) and Fitch Ratings, Inc. (LT Issuer Default Rating) (each as reported by Bloomberg Finance L.P.). EQ shall have no responsibility or liability for any diminution of the Funds that may result from any deposit made by EQ in accordance with this paragraph, including any losses resulting from a default by any bank, financial institution or other third party. EQ may from time to time receive interest, dividends or other earnings in connection with such deposits. EQ shall not be obligated to pay such interest, dividends or earnings to Homology, any holder or any other party.

 

(r)

The obligations of Homology and the rights of the Rights Agent under this Section 3.2, Section 3.1 and Section 2.4 shall survive the expiration of the CVRs and the termination of this Agreement and the resignation, replacement or removal of the Rights Agent.

Section 3.3 Resignation and Removal; Appointment of Successor.

 

(a)

The Rights Agent may resign at any time by written notice to Homology. Any such resignation notice shall specify the date on which such resignation will take effect (which shall be at least thirty (30) days following the date that such resignation notice is delivered), and such resignation will be effective on the earlier of (i) the date so specified and (ii) the appointment of a successor Rights Agent.

 

(b)

Homology will have the right to remove the Rights Agent at any time by written notice to the Rights Agent, specifying the date on which such removal will take effect. Such notice will be given at least thirty (30) days prior to the date so specified (or, if earlier, the appointment of the successor Rights Agent).

 

(c)

If the Rights Agent resigns, is removed or becomes incapable of acting, Homology will promptly appoint a qualified successor Rights Agent. Notwithstanding the foregoing, if Homology fails to make such appointment within a period of thirty (30) days after giving notice of such removal or after it has been notified in writing of such resignation or incapacity by the resigning or incapacitated Rights Agent, then the incumbent Rights Agent may apply to any court of competent jurisdiction for the appointment of a new Rights Agent. The successor Rights Agent so appointed will, upon its acceptance of such appointment in accordance with this Section 3.3(c) and Section 3.4, become the Rights Agent for all purposes hereunder.

 

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(d)

Homology will give notice to the Holders of each resignation or removal of the Rights Agent and each appointment of a successor Rights Agent in accordance with Section 7.2. Each notice will include the name and address of the successor Rights Agent. If Homology fails to send such notice within ten (10) Business Days after acceptance of appointment by a successor Rights Agent, the successor Rights Agent will cause the notice to be mailed at the expense of Homology.

 

(e)

Notwithstanding anything to the contrary in this Section 3.3, unless consented to in writing by the Majority of Holders, Homology will not appoint as a successor Rights Agent any Person that is not a stock transfer agent of national reputation or the corporate trust department of a commercial bank.

 

(f)

The Rights Agent will reasonably cooperate with Homology and any successor Rights Agent in connection with the transition of the duties and responsibilities of the Rights Agent to the successor Rights Agent, including the transfer of all relevant data, including the CVR Register, to the successor Rights Agent, but such predecessor Rights Agent shall not be required to make any additional expenditure or assume any additional liability in connection with the foregoing.

Section 3.4 Acceptance of Appointment by Successor.

Every successor Rights Agent appointed hereunder will, at or prior to such appointment, execute, acknowledge and deliver to Homology and to the resigning or removed Rights Agent an instrument accepting such appointment and a counterpart of this Agreement, and such successor Rights Agent, without any further act, deed or conveyance, will become vested with all the rights, powers, trusts and duties of the Rights Agent; provided that upon the request of Homology or the successor Rights Agent, such resigning or removed Rights Agent will execute and deliver an instrument transferring to such successor Rights Agent all the rights, powers and trusts of such resigning or removed Rights Agent.

ARTICLE 4

COVENANTS

Section 4.1 List of Holders.

Homology will furnish or cause to be furnished to the Rights Agent, in such form as Homology receives from Homology’s transfer agent (or other agent performing similar services for Homology), the names and addresses of the Holders within fifteen (15) Business Days following the Closing Date.

Section 4.2 CVR Committee; Efforts.

 

(a)

The Homology Board has delegated, to a special committee of the Homology Board (the “Special Committee”) comprised of four (4) directors of the Homology Board (the “Initial Special Committee Members”), the primary responsibility, authority and discretion during the Disposition Period with respect to (i) managing the Legacy Assets, (ii) negotiating any Legacy Asset Disposition during the Disposition Period; provided that the Special Committee may not cause the Company to incur costs, expenses or obligations in excess of the Expense Reserve without the prior consent of the Homology Board. The Special Committee shall also be empowered with the authority to authorize and direct any officer of Homology to negotiate, execute and deliver a definitive written agreement with respect to a Legacy Asset Disposition in a form approved by the Special Committee and consistent with this Agreement and the Merger Agreement (a “Sale Agreement”) in the name and on behalf of Homology; provided, however, that no Sale Agreement shall be entered into without the prior review and approval of the Homology Board (such approval not to be unreasonably withheld, conditioned or delayed). In the event (A) any Initial Special Committee Member no longer serves on the Special Committee during the Disposition Period, such vacancy on the Special Committee shall be filled with another director of the Homology Board, and (B) any Initial Special Committee Member who was designated by Homology no longer serves on the Special Committee during

 

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  the Disposition Period, such vacancy on the Special Committee shall be filled with a then-existing member of the Homology Board selected by the member of the post-Closing Homology Board designated by Homology. In each case of (A)-(B) above, the post-Closing Homology Board agrees to install the applicable replacement on the Special Committee.

 

(b)

The delegation of responsibility and authority to the Special Committee set forth in Section 4.2(a) shall not be revoked or modified at any time during the Disposition Period; provided, that the Special Committee shall automatically dissolve upon expiration of the Disposition Period and shall have no further responsibility or authority thereafter. The Special Committee and Homology Board shall not have any liability to the Holders for any actions taken or not taken in accordance with this Agreement in respect of the matters expressly contemplated hereby. No provision of this Agreement shall require the Special Committee or any members thereof to expend or risk its, his or her own funds or otherwise incur any financial liability in the performance of any duties hereunder or in the exercise of any rights or powers hereunder.

 

(c)

The Holders shall be intended third-party beneficiaries of the provisions of this Agreement; provided, that under no circumstances shall the rights of Holders as third-party beneficiaries pursuant to this Article 4 be enforceable by such Holders or any other Person acting for or on their behalf other than the Special Committee (or the Homology Board if the Special Committee no longer exists). The Special Committee (or the Homology Board if the Special Committee no longer exists) has the sole power and authority to act on behalf of the Holders in enforcing any of their rights hereunder.

 

(d)

During the six (6) months immediately following the Closing, Homology will, and will cause its Subsidiaries to, use Commercially Reasonable Efforts to effect Legacy Asset Dispositions with respect to the then-existing Legacy Assets (i) pursuant to a letter of intent for such Legacy Asset Disposition that was executed prior to the Closing Date, and (ii) to a third party that has delivered a bona fide indication of interest to Homology subsequent to the Closing Date, provided that such obligation will not apply to the Oxford Assets. Homology shall use Commercially Reasonable Efforts to exercise the put option on the Oxford Assets contemplated in Section 9.4 of the Limited Liability Company Agreement dated as of March 10, 2022 of OXB Solutions promptly after such put option becomes exercisable on March 10, 2025. During the Disposition Period, if and to the extent the Special Committee recommends, and the Homology Board authorizes and directs, the execution and delivery of any Sale Agreement, Homology will, and will cause its Subsidiaries to, use commercially reasonable efforts to (i) execute and deliver the Sale Agreement, and (ii) effectuate the Legacy Asset Disposition pursuant to such Sale Agreement in accordance with its terms. Notwithstanding anything in this Agreement to the contrary, unless approved by the Special Committee, Homology shall have no obligation whatsoever to enter into any Sale Agreement or other agreement in connection with a Legacy Asset Disposition that imposes on Homology or requires Homology to retain or assume, any material obligations or liabilities, monetary or otherwise, following the consummation of such transaction.

 

(e)

Except as expressly set forth in Article 3, Section 4.2(a), Section 4.2(b) or Section 4.2(d), none of Homology or any of its Subsidiaries shall have any obligation or liability whatsoever to any Person relating to or in connection with any action, or failure to act, with respect to any Legacy Asset Disposition.

 

(f)

Subject to the foregoing clause (d) and the other contractual obligations of Homology expressly set forth in this Agreement, (i) the Holders acknowledge that Homology has a fiduciary obligation to operate its business in the best interests of its stockholders, and any potential obligation to pay CVR Proceeds will not create any express or implied obligation to operate its business in any particular manner in order to maximize such CVR Proceeds, (ii) except as expressly set forth in this Agreement, the Holders are not relying on any representation of Homology or any other Person with regard to any Legacy Asset Disposition or other action involving the Legacy Assets following the Closing, and neither Homology nor any other Person has provided, or can provide, any assurance to the Holders that any CVR Proceeds will in fact be earned and paid, and (iii) none of Homology or any of its Subsidiaries, officers or directors shall have any obligation or liability whatsoever to any Person relating to or in connection with any action, or failure to act, with respect to any Legacy Asset Disposition.

 

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(g)

Following the Disposition Period, Homology shall be permitted to take any action in respect of the Legacy Assets in order to satisfy any Liabilities of or arising from the Legacy Assets, including any wind-down or termination Liabilities. For clarity, following the CVR Period and following the Disposition Period without a Legacy Asset Disposition, Homology may take any action in respect of the Legacy Assets in its sole and absolute discretion.

Section 4.3 Prohibited Actions.

Unless approved by the Special Committee (or the Homology Board if the Special Committee no longer exists), Homology shall not grant any lien, security interest, pledge or similar interest in any Legacy Assets (other than liens or security interests generally granted with respect to all assets of Homology, and not specific to the Legacy Assets, and which do not prohibit the ability of Homology to complete a Legacy Asset Disposition and, in connection therewith, to deliver title to the Legacy Assets to the purchaser thereof, free and clear of such liens and security interests) or any CVR Proceeds.

ARTICLE 5

AMENDMENTS

Section 5.1 Amendments Without Consent of Holders or Rights Agent.

 

(a)

Homology, at any time and from time to time, may (without the consent of any Person, other than the Rights Agent, which such consent not to be unreasonably withheld, conditioned, or delayed) enter into one or more amendments to this Agreement for any of the following purposes, without the consent of any of the Holders or the Rights Agent:

 

  (i)

to evidence the appointment of another Person as a successor Rights Agent and the assumption by any successor Rights Agent of the covenants and obligations of the Rights Agent herein in accordance with the provisions hereof;

 

  (ii)

subject to Section 6.1, to evidence the succession of another person to Homology and the assumption of any such successor of the covenants of Homology outlined herein in a transaction contemplated by Section 6.1;

 

  (iii)

to add to the covenants of Homology such further covenants, restrictions, conditions or provisions for the protection and benefit of the Holders; provided that in each case, such provisions shall not adversely affect the interests of the Holders;

 

  (iv)

to cure any ambiguity, to correct or supplement any provision in this Agreement that may be defective or inconsistent with any other provision in this Agreement, or to make any other provisions with respect to matters or questions arising under this Agreement; provided that in each case, such provisions shall not adversely affect the interests of the Holders;

 

  (v)

as may be necessary or appropriate to ensure that CVRs are not subject to registration under the U.S. Securities Act of 1933, as amended, or the U.S. Securities Exchange Act of 1934, as amended and the rules and regulations made thereunder, or any applicable state securities or “blue sky” laws;

 

  (vi)

as may be necessary or appropriate to ensure that Homology is not required to produce a prospectus or an admission document in order to comply with applicable Law;

 

  (vii)

to cancel CVRs (i) in the event that any Holder has abandoned its rights in accordance with Section 2.6, or (ii) following a transfer of such CVRs to Homology or its Subsidiaries in accordance with Section 2.2 or Section 2.3;

 

  (viii)

as may be necessary or appropriate to ensure that Homology complies with applicable Law; or

 

  (ix)

to effect any other amendment to this Agreement that would provide any additional rights or benefits to the Holders or that does not adversely affect the legal rights under this Agreement of any such Holder.

 

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(b)

Promptly after the execution by Homology of any amendment pursuant to this Section 5.1, Homology will (or will cause the Rights Agent to) notify the Holders in general terms of the substance of such amendment in accordance with Section 7.2.

Section 5.2 Amendments with Consent of Holders.

 

(a)

In addition to any amendments to this Agreement that may be made by Homology without the consent of any Holder or the Rights Agent pursuant to Section 5.1, with the consent of the Majority of Holders, Homology and the Rights Agent may enter into one or more amendments to this Agreement for the purpose of adding, eliminating or amending any provisions of this Agreement, even if such addition, elimination or amendment is adverse to the interests of the Holders.

 

(b)

Promptly after the execution by Homology and the Rights Agent of any amendment pursuant to the provisions of this Section 5.2, Homology will (or will cause the Rights Agent to) notify the Holders in general terms of the substance of such amendment in accordance with Section 7.2.

Section 5.3 Effect of Amendments.

Upon the execution of any amendment under this Article 5, this Agreement will be modified in accordance therewith, such amendment will form a part of this Agreement for all purposes and every Holder will be bound thereby. Upon the delivery of a certificate from an appropriate officer of Homology which states that the proposed supplement or amendment is in compliance with the terms of this Article 5, the Rights Agent shall execute such supplement or amendment. Notwithstanding anything in this Agreement to the contrary, the Rights Agent shall not be required to execute any supplement or amendment to this Agreement that it has determined would adversely affect its own rights, duties, obligations or immunities under this Agreement. No supplement or amendment to this Agreement shall be effective unless duly executed by the Rights Agent.

ARTICLE 6

CONSOLIDATION, MERGER, SALE OR CONVEYANCE

Section 6.1 Homology May Not Consolidate, Etc.

During the CVR Period, Homology shall not consolidate with or merge into any other Person or convey, transfer or lease all or substantially all of its properties and assets to any Person, unless:

 

(a)

the Person formed by such consolidation or into which Homology is merged or the Person that acquires by conveyance or transfer, or that leases, all or substantially all of the properties and assets of Homology (the “Surviving Person”) shall expressly assume Homology’s obligations under this Agreement, including payment of amounts on all CVRs in accordance with the applicable terms; and

 

(b)

Homology has delivered to the Rights Agent an Officer’s Certificate, stating that such consolidation, merger, conveyance, transfer or lease complies with this Article 6.

Section 6.2 Successor Substituted.

Upon any consolidation of or merger by Homology with or into any other Person, or any conveyance, transfer or lease of the properties and assets substantially as an entirety to any Person in accordance with Section 6.1, the Surviving Person shall succeed to, and be substituted for, and may exercise every right and power of, and shall assume all of the obligations of Homology under this Agreement with the same effect as if the Surviving Person had been named as Homology herein.

 

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ARTICLE 7

MISCELLANEOUS

Section 7.1 Notices to Rights Agent and to Homology.

All notices, requests and other communications (each, a “Notice”) to any party hereunder shall be in writing. Such Notice shall be deemed given (a) on the date of delivery, if delivered in person, by Fedex or other internationally recognized overnight courier service or, (except with respect to any Person other than the Rights Agent), by e-mail (upon confirmation of receipt) prior to 5:00 p.m. in the time zone of the receiving party or on the next Business Day, if delivered after 5:00 p.m. in the time zone of the receiving party or (b) on the first Business Day following the date of dispatch, if delivered by FedEx or by other internationally recognized overnight courier service (upon proof of delivery), addressed as follows:

if to the Rights Agent, to:

Equiniti Trust Company, LLC

6201 15th Avenue

Brooklyn, NY 11219

if to Homology, to:

Homology Medicines, Inc.

One Patriots Park

Bedford, MA 01730

Attention: Jodie Morrison

Email: [***]

with a copy, which shall not constitute notice, to:

Goodwin Procter LLP

100 Northern Avenue

Boston, Massachusetts 02210

Attention: John T. Haggerty; Jacqueline Mercier; Tevia K. Pollard

Email: [***]

or to such other address or facsimile number as such party may hereafter specify for the purpose by notice to the other parties hereto.

Section 7.2 Notice to Holders.

All Notices required to be given to the Holders will be given (unless otherwise herein expressly provided) in writing and mailed, first-class postage prepaid, to each Holder at such Holder’s address as set forth in the CVR Register, not later than the latest date, and not earlier than the earliest date, prescribed for the sending of such Notice, if any, and will be deemed given on the date of mailing. In any case where notice to the Holders is given by mail, neither the failure to mail such Notice, nor any defect in any Notice so mailed, to any particular Holder will affect the sufficiency of such Notice with respect to other Holders.

Section 7.3 Entire Agreement.

As between Homology and the Rights Agent, this Agreement constitutes the entire agreement between the parties with respect to the subject matter of this Agreement, notwithstanding the reference to any other agreement herein, and supersedes all prior agreements and understandings, both written and oral, among or between any of the parties with respect to the subject matter of this Agreement.

 

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Section 7.4 Merger or Consolidation or Change of Name of Rights Agent.

Any Person into which the Rights Agent or any successor Rights Agent may be merged or with which it may be consolidated, or Person resulting from any merger or consolidation to which the Rights Agent or any successor Rights Agent shall be a party, or any Person succeeding to the stock transfer or other shareholder services business of the Rights Agent or any successor Rights Agent, shall be the successor to the Rights Agent under this Agreement without the execution or filing of any paper or any further act on the part of any of the parties hereto, provided that such Person would be eligible for appointment as a successor Rights Agent under the provisions of Section 3.3. The purchase of all or substantially all of the Rights Agent’s assets employed in the performance of transfer agent activities shall be deemed a merger or consolidation for purposes of this Section 7.4.

Section 7.5 Successors and Assigns.

This Agreement will be binding upon, and will be enforceable by and inure solely to the benefit of, the Holders, Homology and the Rights Agent and their respective successors and assigns. Except for assignments pursuant to Section 7.4, the Rights Agent may not assign this Agreement without Homology’s prior written consent. Subject to Section 5.1(a)(ii) and Article 6 hereof, Homology may assign, in its sole discretion and without the consent of any other party, any or all of its rights, interests and obligations hereunder to one or more of its Affiliates or to any Person with whom Homology is merged or consolidated, or any entity resulting from any merger or consolidation to which Homology shall be a party (each, an “Assignee”); provided, however, that in connection with any assignment to an Assignee, Homology shall agree to remain liable for the performance by Homology of its obligations hereunder (to the extent Homology exists following such assignment). Homology or an Assignee may not otherwise assign this Agreement without the prior consent of the Majority of Holders. Any attempted assignment of this Agreement in violation of this Section 7.5 will be void ab initio and of no effect.

Section 7.6 Benefits of Agreement; Action by Majority of Holders.

Nothing in this Agreement, express or implied, will give to any Person (other than Homology, the Rights Agent, the Holders and their respective permitted successors and assigns hereunder) any benefit or any legal or equitable right, remedy or claim under this Agreement or under any covenant or provision herein contained, all such covenants and provisions being for the sole benefit of Homology, the Rights Agent, the Holders and their permitted successors and assigns. The Holders will have no rights hereunder except as are expressly set forth herein. Except for the rights of the Rights Agent set forth herein, the Majority of Holders will have the sole right, on behalf of all Holders, by virtue of or under any provision of this Agreement, to institute any action or proceeding at law or in equity with respect to this Agreement, and no individual Holder or other group of Holders will be entitled to exercise such rights.

Section 7.7 Governing Law.

This Agreement and the CVRs will be governed by, and construed in accordance with, the laws of the State of Delaware without regard to the conflicts of law rules of such state.

Section 7.8 Jurisdiction.

In any action or proceeding between any of the parties hereto arising out of or relating to this Agreement or any of the transactions contemplated hereby, each of the parties hereto: (a) irrevocably and unconditionally consents and submits to the exclusive jurisdiction and venue of the Chancery Court of the State of Delaware, County of New Castle, or, if under applicable Law exclusive jurisdiction is vested in the Federal courts, the United States District Court for the District of Delaware (and appellate courts thereof); (b) agrees that all claims in respect of such action or proceeding shall be heard and determined exclusively in accordance with clause (a) of this Section 7.8; (c) waives any objection to laying venue in any such action or proceeding in such courts;

 

15


(d) waives any objection that such courts are an inconvenient forum or do not have jurisdiction over any Party; and (e) agrees that service of process upon such Party in any such action or proceeding shall be effective if notice is given in accordance with Section 7.1 or Section 7.2 of this Agreement.

Section 7.9 WAIVER OF JURY TRIAL.

EACH OF THE PARTIES HERETO (AND BY ACCEPTING THE CVR’ S, THE HOLDERS) HEREBY IRREVOCABLY WAIVES ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF OR RELATED TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY. EACH PARTY CERTIFIES AND ACKNOWLEDGES THAT (I) NO REPRESENTATIVE, AGENT OR ATTORNEY OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF LITIGATION, SEEK TO ENFORCE THE FOREGOING WAIVER, (II) EACH PARTY UNDERSTANDS AND HAS CONSIDERED THE IMPLICATION OF THIS WAIVER, (III) EACH PARTY MAKES THIS WAIVER VOLUNTARILY, AND (IV) EACH PARTY HAS BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION 7.9.

Section 7.10 Severability Clause.

In the event that any provision of this Agreement, or the application of any such provision to any Person or set of circumstances, is for any reason determined to be invalid, unlawful, void or unenforceable to any extent, the remainder of this Agreement, and the application of such provision to Persons or circumstances other than those as to which it is determined to be invalid, unlawful, void or unenforceable, will not be impaired or otherwise affected and will continue to be valid and enforceable to the fullest extent permitted by applicable Law. Upon such a determination, the parties hereto will negotiate in good faith to modify this Agreement so as to effect the original intent of the parties as closely as possible in a mutually acceptable manner in order that the transactions contemplated hereby be consummated as originally contemplated to the fullest extent possible; provided, however, that if an excluded provision shall affect the rights, immunities, liabilities, duties or obligations of the Rights Agent, the Rights Agent shall be entitled to resign immediately upon written notice to Homology.

Section 7.11 Counterparts; Effectiveness.

This Agreement may be signed in any number of counterparts, each of which will be deemed an original, with the same effect as if the signatures thereto and hereto were upon the same instrument. This Agreement or any counterpart may be executed and delivered by facsimile copies or delivered by electronic communications by portable document format (.pdf), each of which shall be deemed an original. This Agreement will become effective when each party hereto will have received a counterpart hereof signed by the other party hereto. Until and unless each party has received a counterpart hereof signed by the other party hereto, this Agreement will have no effect and no party will have any right or obligation hereunder (whether by virtue of any oral or written agreement or any other communication).

Section 7.12 Termination.

This Agreement will automatically terminate and be of no further force or effect and, except as provided in Section 3.2, the parties hereto will have no further liability hereunder, and the CVRs will expire without any consideration or compensation therefor, upon the expiration of the CVR Period. The termination of this Agreement will not affect or limit the right of Holders to receive the CVR Payments under Section 2.4 to the extent earned prior to the termination of this Agreement, and the provisions applicable thereto will survive the expiration or termination of this Agreement.

 

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Section 7.13 Force Majeure.

Notwithstanding anything to the contrary contained herein, none of the Rights Agent, Homology or any of its Subsidiaries (except as it relates to the obligations of the Company under Article 3) will be liable for any delays or failures in performance resulting from acts beyond its reasonable control including acts of God, pandemics (including COVID-19), terrorist acts, shortage of supply, breakdowns or malfunctions, interruptions or malfunctions of computer facilities, or loss of data due to power failures or mechanical difficulties with information storage or retrieval systems, labor difficulties, war or civil unrest.

Section 7.14 Construction.

 

(a)

For purposes of this Agreement, whenever the context requires: singular terms will include the plural, and vice versa; the masculine gender will include the feminine and neuter genders; the feminine gender will include the masculine and neuter genders; and the neuter gender will include the masculine and feminine genders.

 

(b)

As used in this Agreement, the words “include” and “including,” and variations thereof, will not be deemed to be terms of limitation, but rather will be deemed to be followed by the words “without limitation.”

 

(c)

The headings contained in this Agreement are for convenience of reference only, will not be deemed to be a part of this Agreement and will not be referred to in connection with the construction or interpretation of this Agreement.

 

(d)

Any reference in this Agreement to a date or time shall be deemed to be such date or time in New York City, United States, unless otherwise specified. The parties hereto and Homology have participated jointly in the negotiation and drafting of this Agreement. In the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the parties and Homology and no presumption or burden of proof shall arise favoring or disfavoring any Person by virtue of the authorship of any provision of this Agreement.

 

(e)

All references herein to “$” are to United States Dollars.

[Remainder of page intentionally left blank]

 

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IN WITNESS WHEREOF, each of the parties has caused this Agreement to be executed as of the day and year first above written.

 

[__]
By:  

 

Name:
Title:
EQUINITI TRUST COMPANY, LLC, as Rights Agent
By:  

 

Name:
Title:

[Signature Page to CVR Agreement]

Exhibit 10.8

Amended and Restated Employment Agreement

This Amended and Restated Employment Agreement (this “Agreement”), dated as of November 16, 2023, is made by and between Homology Medicines, Inc., a Delaware corporation (together with any successor thereto, the “Company”), and Paul Alloway, Ph.D., J.D. (“Executive”) (collectively referred to herein as the “Parties” or individually referred to as a “Party”), and effective as of November 17, 2023 (the “Effective Date”).

RECITALS

 

A.

It is the desire of the Company to assure itself of the services of Executive as of the Effective Date and thereafter by entering into this Agreement, which shall supersede and replace any prior employment arrangement, including, but not limited to, that certain Employment Agreement, dated as of March 18, 2020, between the Parties, as amended as of September 6, 2020 (the “Prior Agreement”).

 

B.

Executive and the Company mutually desire that Executive provide services to the Company on the terms herein provided.

AGREEMENT

NOW, THEREFORE, in consideration of the foregoing and of the respective covenants and agreements set forth below, the Parties hereto agree as follows:

1. Employment.

(a) General. Effective on the Effective Date, the Company shall continue to employ Executive, and Executive shall remain employed by the Company, for the period and in the positions set forth in this Section 1, and subject to the other terms and conditions herein provided.

(b) At-Will Employment. The Company and Executive acknowledge that Executive’s employment is and shall continue to be at-will, as defined under applicable law, and that Executive’s employment with the Company may be terminated by either Party at any time for any or no reason (subject to the notice requirements of Section 3(b)). This “at-will” nature of Executive’s employment shall remain unchanged during Executive’s tenure as an employee and may not be changed, except in an express writing signed by Executive and a duly authorized officer of the Company. If Executive’s employment terminates for any reason, Executive shall not be entitled to any payments, benefits, damages, award or compensation other than as provided in this Agreement or otherwise agreed to in writing by the Company or as provided by applicable law. The term of this Agreement (the “Term”) shall commence on the Effective Date and end on the date this Agreement is terminated under Section 3.

(c) Positions and Duties. During the Term, Executive shall serve as President and Chief Operating Officer of the Company, with such responsibilities, duties and authority normally associated with such position and as may from time to time be assigned to Executive by the Board of Directors of the Company or an authorized committee thereof (in either case, the “Board”). Executive shall devote substantially all of Executive’s working time and efforts to the business and affairs of the Company (which shall include service to its affiliates, if applicable) and shall not engage in outside business activities (including serving on outside boards or committees) without the consent of the Board, provided that Executive shall be permitted to (i) manage Executive’s personal, financial and legal affairs, (ii) participate in trade associations, and (iii) serve on the board of directors of not-for-profit or tax-exempt


charitable organizations, in each case, subject to compliance with this Agreement and provided that such activities do not materially interfere with Executive’s performance of Executive’s duties and responsibilities hereunder. Executive agrees to observe and comply with the rules and policies of the Company as adopted by the Company from time to time, in each case, as amended from time to time, and as delivered or made available to Executive (each, a “Policy”).

2. Compensation and Related Matters.

(a) Annual Base Salary. During the Term, Executive shall receive a base salary at a rate of $462,425 per annum, which shall be paid in accordance with the customary payroll practices of the Company and shall be pro-rated for partial years of employment. Such annual base salary shall be reviewed (and may be adjusted) from time to time by the Board (such annual base salary, as it may be adjusted from time to time, the “Annual Base Salary”).

(b) 2023 Annual Bonus; Change in Control Bonus.

(i) Executive shall receive an amount in cash equal to 50% of Executive’s target annual bonus for the Company’s 2023 fiscal year (the “2023 Annual Bonus”), payable in a lump sum payment following completion of the 2023 fiscal year, but in any event no later than March 15, 2024. The payment of the 2023 Annual Bonus shall be subject to Executive’s continued employment with the Company through the date of payment, except as otherwise provided in Section 4(b)(ii).

(ii) Subject to Executive’s continued employment through the Closing (except as otherwise expressly provided in Section 4(b)(vi) and, if applicable, Section 4(c)(i)(A)), Executive shall receive an amount in cash equal to Executive’s Annual Base Salary, multiplied by a fraction, the numerator of which is the number of days elapsed from July 27, 2023 through the date of the Closing and the denominator of which is 365, up to a maximum of cash payment equal to $269,747.92 (the “Change in Control Bonus”). The Change in Control Bonus shall be payable in a lump sum payment on the first regular payroll date of the Company that is at least five (5) business days after the Closing, in accordance with the Company’s normal payroll practices.

(c) Benefits. During the Term, Executive shall be eligible to participate in employee benefit plans, programs and arrangements of the Company (including medical, dental and 401(k) plans), subject to the terms and eligibility requirements thereof and as such plans, programs and arrangements may be amended from time to time. In no event shall Executive be eligible to participate in any severance plan or program of the Company, except as set forth in Section 4 of this Agreement.

(d) Vacation. During the Term, Executive shall be entitled to paid personal leave in accordance with the Company’s Policies. Any vacation shall be taken at the reasonable and mutual convenience of the Company and Executive.

(e) Business Expenses. During the Term, the Company shall reimburse Executive for all reasonable travel and other business expenses incurred by Executive in the performance of Executive’s duties to the Company in accordance with the Company’s expense reimbursement Policy.

(f) Key Person Insurance. At any time during the Term, the Company shall have the right (but not the obligation) to insure the life of Executive for the Company’s sole benefit. The Company shall have the right to determine the amount of insurance and the type of policy. Executive shall reasonably cooperate with the Company in obtaining such insurance by submitting to physical examinations, by supplying all information reasonably required by any insurance carrier, and by executing all necessary documents reasonably required by any insurance carrier, provided that any information provided to an insurance company or broker shall not be provided to the Company without the prior written authorization of Executive. Executive shall incur no financial obligation by executing any required document, and shall have no interest in any such policy.

 

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3. Termination. Executive’s employment hereunder and the Term may be terminated by the Company or Executive, as applicable, without any breach of this Agreement under the following circumstances and the Term will end on the Date of Termination:

(a) Circumstances.

(i) Death. Executive’s employment hereunder shall terminate upon Executive’s death.

(ii) Disability. If Executive has incurred a Disability, as defined below, the Company may terminate Executive’s employment.

(iii) Termination for Cause. The Company may terminate Executive’s employment for Cause, as defined below.

(iv) Termination without Cause. The Company may terminate Executive’s employment without Cause.

(v) Resignation from the Company with Good Reason. Executive may resign Executive’s employment with the Company with Good Reason, as defined below.

(vi) Resignation from the Company without Good Reason. Executive may resign Executive’s employment with the Company for any reason other than Good Reason or for no reason.

(b) Notice of Termination. Any termination of Executive’s employment by the Company or by Executive under this Section 3 (other than termination pursuant to Section 3(a)(i)) shall be communicated by a written notice to the other Party hereto (i) indicating the specific termination provision in this Agreement relied upon, (ii) setting forth in reasonable detail the facts and circumstances claimed to provide a basis for termination of Executive’s employment under the provision so indicated, if applicable, and (iii) specifying a Date of Termination which, if submitted by Executive, shall be at least thirty (30) days following the date of such notice (a “Notice of Termination”); provided, however, that in the event that Executive delivers a Notice of Termination to the Company, the Company may, in its sole discretion, change the Date of Termination to any date that occurs following the date of the Company’s receipt of such Notice of Termination and is prior to the date specified in such Notice of Termination, but the termination will still be considered a resignation by Executive. A Notice of Termination submitted by the Company may provide for a Date of Termination on the date Executive receives the Notice of Termination, or any date thereafter elected by the Company. The failure by either Party to set forth in the Notice of Termination any fact or circumstance which contributes to a showing of Cause or Good Reason shall not waive any right of the Party hereunder or preclude the Party from asserting such fact or circumstance in enforcing the Party’s rights hereunder.

 

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(c) Company Obligations upon Termination. Upon termination of Executive’s employment pursuant to any of the circumstances listed in this Section 3, Executive (or Executive’s estate) shall be entitled to receive the sum of: (i) the portion of Executive’s Annual Base Salary earned through the Date of Termination, but not yet paid to Executive; (ii) any expense reimbursements owed to Executive pursuant to Section 2(e); and (iii) any amount accrued and arising from Executive’s participation in, or benefits accrued under any employee benefit plans, programs or arrangements, which amounts shall be payable in accordance with the terms and conditions of such employee benefit plans, programs or arrangements (collectively, the “Company Arrangements”). Except as otherwise expressly required by law (e.g., COBRA) or as specifically provided herein, all of Executive’s rights to salary, severance, benefits, bonuses and other compensatory amounts hereunder (if any) shall cease upon the termination of Executive’s employment hereunder. In the event that Executive’s employment is terminated by the Company for any reason, Executive’s sole and exclusive remedy shall be to receive the payments and benefits described in this Section 3(c) or Section 4, as applicable.

(d) Deemed Resignation. Upon termination of Executive’s employment for any reason, Executive shall be deemed to have resigned from all offices and directorships, if any, then held with the Company or any of its subsidiaries.

4. Severance Payments.

(a) Termination for Cause, or Termination Upon Death, Disability or Resignation from the Company Without Good Reason. If Executive’s employment shall terminate as a result of Executive’s death pursuant to Section 3(a)(i) or Disability pursuant to Section 3(a)(ii), pursuant to Section 3(a)(iii) for Cause, or pursuant to Section 3(a)(iv) due to Executive’s resignation from the Company without Good Reason, then Executive shall not be entitled to any severance payments or benefits, except as provided in Section 3(c).

(b) Termination without Cause, or Resignation from the Company with Good Reason. If Executive’s employment terminates without Cause pursuant to Section 3(a)(iv), or pursuant to Section 3(a)(v) due to Executive’s resignation with Good Reason (in either case, a “Qualifying Termination”), then, subject to Executive signing on or before the forty-fifth (45th) day following Executive’s Separation from Service (as defined below), and not revoking, a release of claims substantially in the form attached as Exhibit A to this Agreement (the “Release”), and Executive’s continued compliance with Section 5, Executive shall receive, in addition to payments and benefits set forth in Section 3(c), the following:

(i) an amount in cash equal to 1.0 times the Annual Base Salary, payable in the form of salary continuation in regular installments over the 12-month period following the date of Executive’s Separation from Service (the “Severance Period”) in accordance with the Company’s normal payroll practices;

(ii) to the extent unpaid as of the Date of Termination, the 2023 Annual Bonus shall be paid at such time that bonuses for the 2023 fiscal year are paid to actively employed employees of the Company, but in any event no later than March 15, 2024;

(iii) if Executive timely elects to receive continued medical, dental or vision coverage under one or more of the Company’s group medical, dental or vision plans pursuant to the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended (“COBRA”), then the Company shall directly pay, or reimburse Executive for, the COBRA premiums for Executive and Executive’s covered dependents under such plans, less the amount Executive would have had to pay to receive such coverage as an active employee based on the cost sharing levels in effect on the Date of Termination, during the period commencing on Executive’s Separation from

 

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Service and ending upon the earliest of (X) the last day of the Severance Period, (Y) the date that Executive and/or Executive’s covered dependents become no longer eligible for COBRA or (Z) the date Executive becomes eligible to receive medical, dental or vision coverage, as applicable, from a subsequent employer (and Executive agrees to promptly notify the Company of such eligibility). Notwithstanding the foregoing, if the Company determines in its sole discretion that it cannot provide the foregoing benefit without potentially violating applicable law (including, without limitation, Section 2716 of the Public Health Service Act) or incurring an excise tax, the Company shall in lieu thereof provide to Executive a taxable monthly payment in an amount equal to the monthly COBRA premium that Executive would be required to pay to continue Executive’s and Executive’s covered dependents’ group health coverage in effect on the Date of Termination (which amount shall be based on the premium for the first month of COBRA coverage), less the amount Executive would have had to pay to receive group health coverage as an active employee for Executive and his or her covered dependents based on the cost sharing levels in effect on the Date of Termination, which payments shall be made regardless of whether Executive elects COBRA continuation coverage and shall commence in the month following the month in which the Date of Termination occurs and shall end on the earliest of (X) the last day of the Severance Period, (Y) the date that Executive and/or Executive’s covered dependents become no longer eligible for COBRA or (Z) the date Executive becomes eligible to receive healthcare coverage from a subsequent employer (and Executive agrees to promptly notify the Company of such eligibility);

(iv) each outstanding option (“Option”) to purchase shares of the Company’s common stock that was granted to Executive under the Company’s 2018 Incentive Award Plan (the “2018 Plan”) or the Company’s 2015 Stock Incentive Plan (the “2015 Plan”) and that is vested and unexercised as of the date of Executive’s Separation from Service (each, a “Subject Option”) will remain outstanding and exercisable until the first anniversary of the date of Executive’s Separation from Service; provided, that (A) no Subject Option will remain outstanding past the final expiration date of such Subject Option set forth in the award agreement governing such Subject Option and (B) each Subject Option will in all events remain subject to earlier termination in connection with a corporate transaction or event (including the Closing (as defined below)) in accordance with the terms of the award agreement governing such Subject Option and the 2018 Plan or 2015 Plan, as applicable;

(v) the vesting of outstanding restricted stock units that were granted to Executive under the 2018 Plan that vest in annual installments based on continuous service to the Company and are unvested as of the date of Executive’s Separation from Service (“Subject RSUs”) will accelerate as to the portion of such Subject RSUs equal to, for a given award of Subject RSUs, the product of (A) the number of Subject RSUs scheduled to vest on the first annual vesting date of such award after the date of Executive’s Separation from Service multiplied by (B) a fraction, the numerator of which is the number of days elapsed since the last annual vesting date of such award (or the grant date if no vesting under such award has occurred) and the denominator of which is 365, rounded down to the nearest whole Subject RSU (the “Vested RSUs”); and

(vi) in the event such Qualifying Termination occurs prior to the Closing, an amount in cash equal to $115,606.25 (the “Partial Change in Control Bonus”), payable in a lump sum payment in accordance with the Company’s normal payroll practices.

(c) Change in Control. In the event Executive’s employment terminates due to a Qualifying Termination either (x) prior to the Closing and provided such Closing occurs during the Pre-CIC Protection Period or (y) during the Post-CIC Protection Period, then subject to Executive signing on or before the forty-fifth (45th) day following Executive’s Separation from Service, and not revoking, the Release, and Executive’s continued compliance with Section 5, Executive shall receive, in addition to the payments and benefits set forth in Section 4(b), the following:

(i) if such Qualifying Termination occurs during the Pre-CIC Protection Period:

 

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(A) if, to the reasonable satisfaction of the Company, Executive remains available from the date of Executive’s Separation from Service until the Closing to answer questions and provide transition advice to the Company relating to Executive’s former duties, area of work experience and expertise as are reasonably requested by the Company from time to time, an amount in cash equal to the excess of the Change in Control Bonus (determined in accordance with Section 2(b)(ii) (disregarding, for this purpose, the continued service requirement applicable thereunder) over the Partial Change in Control Bonus, payable in a lump sum payment in accordance with the Company’s normal payroll practices and in any event no earlier than the first regular payroll date of the Company that is at least five (5) business days after the Closing; and

(B) (I) all Subject RSUs that do not become Vested RSUs in accordance with Section 4(b)(v) and all outstanding Options that are not Subject Options shall vest upon the Closing (and for the avoidance of doubt, notwithstanding their contrary terms, shall remain outstanding and eligible to vest upon the Closing if the Closing occurs during the Pre-CIC Protection Period, and will be forfeited upon expiration of the Pre-CIC Protection Period if the Closing has not occurred or upon the earlier termination of the Merger Agreement without the Closing occurring) and (II) all outstanding Options that vest upon the Closing in accordance with this Section 4(c)(i)(B) shall remain outstanding and exercisable following vesting until the first anniversary of the date of Executive’s Separation from Service; provided, that (x) no such Option will remain outstanding past the final expiration date of such Option set forth in the award agreement governing such Option and (y) each Option will in all events remain subject to earlier termination in connection with a corporate transaction or event (including the Closing) in accordance with the terms of the award agreement governing such Subject Option and the 2018 Plan or 2015 Plan, as applicable; or

(ii) if such Qualifying Termination occurs during the Post-CIC Protection Period:

(A) all unvested equity or equity-based awards held by Executive under any Company equity compensation plans that vest solely based on the passage of time shall immediately become 100% vested (for the avoidance of doubt, with any such awards that vest in whole or in part based on the attainment of performance-vesting conditions being governed by the terms of the applicable award agreement); and

(B) all outstanding Options that vested upon the Closing in accordance with the Merger Agreement or that vest in accordance with Section 4(c)(ii)(A) shall remain outstanding and exercisable following vesting until the first anniversary of the date of Executive’s Separation from Service; provided, that (x) no such Option will remain outstanding past the final expiration date of such Option set forth in the award agreement governing such Option and (y) each Option will in all events remain subject to earlier termination in connection with a corporate transaction or event (including the Closing) in accordance with the terms of the award agreement governing such Option and the applicable Company equity compensation plan.

 

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(d) Survival. Notwithstanding anything to the contrary in this Agreement, the provisions of Sections 5 through 9 will survive the termination of Executive’s employment and the termination of the Term.

5. Restrictive Covenants. Executive previously executed and delivered to the Company a Nondisclosure, Nonsolicitation, and Assignment of Intellectual Property Agreement (the “Restrictive Covenant Agreement”). Executive acknowledges and agrees that, as a condition to the effectiveness of this Agreement, Executive continues to be bound by the terms of the Restrictive Covenant Agreement, which are hereby incorporated by reference into this Agreement. Executive acknowledges that the provisions of the Restrictive Covenant Agreement will survive the termination of Executive’s employment and the termination of the Term for the periods set forth in the Restrictive Covenant Agreement.

6. Assignment and Successors.

The Company may assign its rights and obligations under this Agreement to any of its affiliates or to any successor to all or substantially all of the business or the assets of the Company (by merger or otherwise), and may assign or encumber this Agreement and its rights hereunder as security for indebtedness of the Company and its affiliates. This Agreement shall be binding upon and inure to the benefit of the Company, Executive and their respective successors, assigns, personnel and legal representatives, executors, administrators, heirs, distributees, devisees, and legatees, as applicable. None of Executive’s rights or obligations may be assigned or transferred by Executive, other than Executive’s rights to payments hereunder, which may be transferred only by will or operation of law. Notwithstanding the foregoing, Executive shall be entitled, to the extent permitted under applicable law and applicable Company Arrangements, to select and change a beneficiary or beneficiaries to receive compensation hereunder following Executive’s death by giving written notice thereof to the Company.

7. Certain Definitions.

(a) Cause. The Company shall have “Cause” to terminate Executive’s employment hereunder upon:

(i) The Board’s reasonable, good faith determination that Executive has refused to (A) substantially perform the duties associated with Executive’s position with the Company or (B) carry out the reasonable and lawful instructions of the Board concerning duties or actions consistent with the Executive’s position with the Company;

(ii) Executive’s breach of a material provision of this Agreement that, to the extent capable of cure, has remained uncured for a period of thirty (30) days following written notice from the Company;

(iii) Executive’s conviction, plea of no contest, plea of nolo contendere, or imposition of unadjudicated probation for any felony or crime involving moral turpitude;

(iv) Executive’s unlawful use (including being under the influence) or possession of illegal drugs on the Company’s (or any of its affiliate’s) premises or while performing Executive’s duties and responsibilities under this Agreement; or

(v) Executive’s commission of any act of fraud, embezzlement, misappropriation, willful misconduct, or breach of fiduciary duty against the Company or any of its affiliates.

 

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(b) Change in Control. “Change in Control” shall have the meaning set forth in the Homology Medicines, Inc. 2018 Incentive Award Plan.

(c) Closing. “Closing” means the consummation of the transactions contemplated by the Merger Agreement.

(d) Code. “Code” shall mean the Internal Revenue Code of 1986, as amended, and the regulations and guidance promulgated thereunder.

(e) Date of Termination. “Date of Termination” shall mean (i) if Executive’s employment is terminated by Executive’s death, the date of Executive’s death; or (ii) if Executive’s employment is terminated pursuant to Section 3(a)(ii) – (vi) either the date indicated in the Notice of Termination or the date specified by the Company pursuant to Section 3(b), whichever is earlier.

(f) Disability. “Disability” shall mean, at any time the Company or any of its affiliates sponsors a long-term disability plan for the Company’s employees, “disability” as defined in such long-term disability plan for the purpose of determining a participant’s eligibility for benefits, provided, however, if the long-term disability plan contains multiple definitions of disability, “Disability” shall refer to that definition of disability which, if Executive qualified for such disability benefits, would provide coverage for the longest period of time. The determination of whether Executive has a Disability shall be made by the person or persons required to make disability determinations under the long-term disability plan. At any time the Company does not sponsor a long-term disability plan for its employees, “Disability” shall mean Executive’s inability to perform, with or without reasonable accommodation, the essential functions of Executive’s positions hereunder for a total of three months during any six-month period as a result of incapacity due to mental or physical illness as determined by a physician selected by the Company or its insurers and acceptable to Executive or Executive’s legal representative, with such agreement as to acceptability not to be unreasonably withheld or delayed. Any refusal by Executive to submit to a medical examination for the purpose of determining Disability shall be deemed to constitute conclusive evidence of Executive’s Disability.

(g) Good Reason. For the sole purpose of determining Executive’s right to severance payments and benefits as described above, Executive’s resignation will be with “Good Reason” if Executive resigns within ninety (90) days after any of the following events, unless Executive consents in writing to the applicable event: (i) a reduction in Executive’s Annual Base Salary or Target Annual Bonus, (ii) a material decrease in Executive’s authority or areas of responsibility as are commensurate with Executive’s title or position with the Company, (iii) the relocation of Executive’s primary office to a location more than twenty-five (25) miles from the Executive’s primary office as of the date of this Agreement or (iv) the Company’s breach of a material provision of this Agreement. Notwithstanding the foregoing, no Good Reason will have occurred unless and until Executive has: (a) provided the Company, within sixty (60) days of Executive’s knowledge of the occurrence of the facts and circumstances underlying the Good Reason event, written notice stating with specificity the applicable facts and circumstances underlying such finding of Good Reason; (b) provided the Company with an opportunity to cure the same within thirty (30) days after the receipt of such notice; and (c) the Company shall have failed to so cure within such period.

(h) Merger Agreement. “Merger Agreement” means that certain Agreement and Plan of Merger, by and among the Company, Kenobi Merger Sub, Inc. and Q32 Bio Inc., dated as of the Signing Date.

 

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(i) Post-CIC Protection Period. “Post-CIC Protection Period” means the period beginning on the effective date of a Change in Control and ending on the date that is twelve (12) months following the date of such Change in Control.

(j) Pre-CIC Protection Period. “Pre-CIC Protection Period” means the period commencing on the Signing Date and ending on the date that is nine (9) months after the Signing Date.

(k) Signing Date. “Signing Date” means the date of the Merger Agreement.

8. Parachute Payments.

(a) Notwithstanding any other provisions of this Agreement or any Company equity plan or agreement, in the event that any payment or benefit by the Company or otherwise to or for the benefit of Executive, whether paid or payable or distributed or distributable pursuant to the terms of this Agreement or otherwise (all such payments and benefits, including the payments and benefits under Section 4 hereof, being hereinafter referred to as the “Total Payments”), would be subject (in whole or in part) to the excise tax imposed by Section 4999 of the Code (the “Excise Tax”), then the Total Payments shall be reduced (in the order provided in Section 8(b)) to the minimum extent necessary to avoid the imposition of the Excise Tax on the Total Payments, but only if (i) the net amount of such Total Payments, as so reduced (and after subtracting the net amount of federal, state and local income and employment taxes on such reduced Total Payments and after taking into account the phase out of itemized deductions and personal exemptions attributable to such reduced Total Payments), is greater than or equal to (ii) the net amount of such Total Payments without such reduction (but after subtracting the net amount of federal, state and local income and employment taxes on such Total Payments and the amount of the Excise Tax to which Executive would be subject in respect of such unreduced Total Payments and after taking into account the phase out of itemized deductions and personal exemptions attributable to such unreduced Total Payments).

(b) The Total Payments shall be reduced in the following order: (i) reduction on a pro-rata basis of any cash severance payments that are exempt from Section 409A of the Code (“Section 409A”), (ii) reduction on a pro-rata basis of any non-cash severance payments or benefits that are exempt from Section 409A, (iii) reduction on a pro-rata basis of any other payments or benefits that are exempt from Section 409A, and (iv) reduction of any payments or benefits otherwise payable to Executive on a pro-rata basis or such other manner that complies with Section 409A; provided, in case of clauses (ii), (iii) and (iv), that reduction of any payments attributable to the acceleration of vesting of Company equity awards shall be first applied to Company equity awards that would otherwise vest last in time.

(c) All determinations regarding the application of this Section 8 shall be made by an accounting firm or consulting group with experience in performing calculations regarding the applicability of Section 280G of the Code and the Excise Tax selected by the Company (the “Independent Advisors”). For purposes of determinations, no portion of the Total Payments shall be taken into account which, in the opinion of the Independent Advisors, (i) does not constitute a “parachute payment” within the meaning of Section 280G(b)(2) of the Code (including by reason of Section 280G(b)(4)(A) of the Code) or (ii) constitutes reasonable compensation for services actually rendered, within the meaning of Section 280G(b)(4)(B) of the Code, in excess of the “base amount” (as defined in Section 280G(b)(3) of the Code) allocable to such reasonable compensation. The costs of obtaining such determination and all related fees and expenses (including related fees and expenses incurred in any later audit) shall be borne by the Company.

 

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(d) In the event it is later determined that a greater reduction in the Total Payments should have been made to implement the objective and intent of this Section 8, the excess amount shall be returned promptly by Executive to the Company.

9. Miscellaneous Provisions.

(a) Governing Law. This Agreement shall be governed, construed, interpreted and enforced in accordance with its express terms, and otherwise in accordance with the substantive laws of the Commonwealth of Massachusetts without reference to the principles of conflicts of law of the Commonwealth of Massachusetts or any other jurisdiction that would result in the application of the laws of a jurisdiction other than the Commonwealth of Massachusetts, and where applicable, the laws of the United States.

(b) Validity. The invalidity or unenforceability of any provision or provisions of this Agreement shall not affect the validity or enforceability of any other provision of this Agreement, which shall remain in full force and effect.

(c) Notices. Any notice, request, claim, demand, document and other communication hereunder to any Party shall be effective upon receipt (or refusal of receipt) and shall be in writing and delivered personally or sent by facsimile or certified or registered mail, postage prepaid, as follows:

(i) If to the Company, to the Chair of the Board at the Company’s headquarters,

(ii) If to Executive, to the last address that the Company has in its personnel records for Executive, or

(iii) At any other address as any Party shall have specified by notice in writing to the other Party.

(d) Counterparts. This Agreement may be executed in several counterparts, each of which shall be deemed to be an original, but all of which together will constitute one and the same Agreement. Signatures delivered by facsimile or PDF shall be deemed effective for all purposes.

(e) Entire Agreement. The terms of this Agreement, and the Restrictive Covenant Agreement incorporated herein by reference as set forth in Section 5, are intended by the Parties to be the final expression of their agreement with respect to the subject matter hereof and supersede all prior understandings and agreements, whether written or oral, including the Prior Agreement. The Parties further intend that this Agreement shall constitute the complete and exclusive statement of their terms and that no extrinsic evidence whatsoever may be introduced in any judicial, administrative, or other legal proceeding to vary the terms of this Agreement.

(f) Amendments; Waivers. This Agreement may not be modified, amended, or terminated except by an instrument in writing, signed by Executive and a duly authorized officer of Company. By an instrument in writing similarly executed, Executive or a duly authorized officer of the Company may waive compliance by the other Party with any specifically identified provision of this Agreement that such other Party was or is obligated to comply with or perform; provided, however, that such waiver shall not operate as a waiver of, or estoppel with respect to, any other or subsequent failure. No failure to exercise and no delay in exercising any right, remedy, or power hereunder will preclude any other or further exercise of any other right, remedy, or power provided herein or by law or in equity.

 

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(g) Construction. This Agreement shall be deemed drafted equally by both the Parties. Its language shall be construed as a whole and according to its fair meaning. Any presumption or principle that the language is to be construed against any Party shall not apply. The headings in this Agreement are only for convenience and are not intended to affect construction or interpretation. Any references to paragraphs, subparagraphs, sections or subsections are to those parts of this Agreement, unless the context clearly indicates to the contrary. Also, unless the context clearly indicates to the contrary, (i) the plural includes the singular and the singular includes the plural; (ii) “and” and “or” are each used both conjunctively and disjunctively; (iii) “any,” “all,” “each,” or “every” means “any and all,” and “each and every”; (iv) “includes” and “including” are each “without limitation”; (v) “herein,” “hereof,” “hereunder” and other similar compounds of the word “here” refer to the entire Agreement and not to any particular paragraph, subparagraph, section or subsection; and (vi) all pronouns and any variations thereof shall be deemed to refer to the masculine, feminine, neuter, singular or plural as the identity of the entities or persons referred to may require.

(h) Arbitration. Any controversy, claim or dispute arising out of or relating to this Agreement, shall be settled solely and exclusively by a binding arbitration process administered by JAMS/Endispute in Boston, Massachusetts. Such arbitration shall be conducted in accordance with the then-existing JAMS/Endispute Rules of Practice and Procedure, with the following exceptions if in conflict: (i) one arbitrator who is a retired judge shall be chosen by JAMS/Endispute; (ii) each Party to the arbitration will pay one-half of the expenses and fees of the arbitrator, together with other expenses of the arbitration incurred or approved by the arbitrator; and (iii) arbitration may proceed in the absence of any Party if written notice (pursuant to the JAMS/Endispute rules and regulations) of the proceedings has been given to such Party. Each Party shall bear its own attorney’s fees and expenses; provided that the arbitrator may assess the prevailing Party’s fees and costs against the non-prevailing Party as part of the arbitrator’s award. The Parties agree to abide by all decisions and awards rendered in such proceedings. Such decisions and awards rendered by the arbitrator shall be final and conclusive. All such controversies, claims or disputes shall be settled in this manner in lieu of any action at law or equity; provided, however, that nothing in this subsection shall be construed as precluding the bringing of an action for injunctive relief or specific performance as provided in this Agreement or the Restrictive Covenant Agreement. This dispute resolution process and any arbitration hereunder shall be confidential and neither any Party nor the neutral arbitrator shall disclose the existence, contents or results of such process without the prior written consent of all Parties, except where necessary or compelled in a court to enforce this arbitration provision or an award from such arbitration or otherwise in a legal proceeding. If JAMS/Endispute no longer exists or is otherwise unavailable, the Parties agree that the American Arbitration Association (“AAA”) shall administer the arbitration in accordance with its then-existing rules as modified by this subsection. In such event, all references herein to JAMS/Endispute shall mean AAA. Notwithstanding the foregoing, Executive and the Company each have the right to resolve any issue or dispute over intellectual property rights by court action instead of arbitration.

(i) Enforcement. If any provision of this Agreement is held to be illegal, invalid or unenforceable under present or future laws effective during the Term, such provision shall be fully severable; this Agreement shall be construed and enforced as if such illegal, invalid or unenforceable provision had never comprised a portion of this Agreement; and the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid or unenforceable provision or by its severance from this Agreement. Furthermore, in lieu of such illegal, invalid or unenforceable provision there shall be added automatically as part of this Agreement a provision as similar in terms to such illegal, invalid or unenforceable provision as may be possible and be legal, valid and enforceable.

(j) Withholding. The Company shall be entitled to withhold from any amounts payable under this Agreement any federal, state, local or foreign withholding or other taxes or charges which the Company is required to withhold. The Company shall be entitled to rely on the advice of counsel if any questions as to the amount or requirement of withholding shall arise.

 

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(k) Section 409A.

(i) General. The intent of the Parties is that the payments and benefits under this Agreement comply with or be exempt from Section 409A and, accordingly, to the maximum extent permitted, this Agreement shall be interpreted to be in compliance therewith.

(ii) Separation from Service. Notwithstanding anything in this Agreement to the contrary, any compensation or benefits payable under this Agreement that is designated under this Agreement as payable upon Executive’s termination of employment shall be payable only upon Executive’s “separation from service” with the Company within the meaning of Section 409A (a “Separation from Service”). Except as provided below, and notwithstanding anything in this Agreement to the contrary, any compensation or benefits described in Section 4 shall not be paid, or, in the case of installments, shall not commence payment, until the first regular payroll date of the Company that is at least five (5) business days following the date the Release becomes effective and irrevocable in accordance with its terms or, if Executive’s Separation from Service occurs on or after November 1st of any calendar year, on the first regular payroll date of the calendar year beginning immediately after the calendar year in which Executive’s Separation from Service occurs, with the first payment to include any installments that would have been paid earlier if the Release had become effective and irrevocable on the date of Executive’s Separation from Service.

(iii) Specified Employee. Notwithstanding anything in this Agreement to the contrary, if Executive is deemed by the Company at the time of Executive’s Separation from Service to be a “specified employee” for purposes of Section 409A, to the extent delayed commencement of any portion of the benefits to which Executive is entitled under this Agreement is required in order to avoid a prohibited distribution under Section 409A, such portion of Executive’s benefits shall not be provided to Executive prior to the earlier of (i) the expiration of the six-month period measured from the date of Executive’s Separation from Service with the Company or (ii) the date of Executive’s death. Upon the first business day following the expiration of the applicable Section 409A period, all payments deferred pursuant to the preceding sentence shall be paid in a lump sum to Executive (or Executive’s estate or beneficiaries), and any remaining payments due to Executive under this Agreement shall be paid as otherwise provided herein.

(iv) Expense Reimbursements. To the extent that any reimbursements under this Agreement are subject to Section 409A, any such reimbursements payable to Executive shall be paid to Executive no later than December 31 of the year following the year in which the expense was incurred; provided that, Executive submits Executive’s reimbursement request promptly following the date the expense is incurred, the amount of expenses reimbursed in one year shall not affect the amount eligible for reimbursement in any subsequent year, other than medical expenses referred to in Section 105(b) of the Code, and Executive’s right to reimbursement under this Agreement will not be subject to liquidation or exchange for another benefit.

(v) Installments. Executive’s right to receive any installment payments under this Agreement, including without limitation any continuation salary payments that are payable on Company payroll dates, shall be treated as a right to receive a series of separate payments and, accordingly, each such installment payment shall at all times be considered a separate and distinct payment as permitted under Section 409A. Except as otherwise permitted under Section 409A, no payment hereunder shall be accelerated or deferred unless such acceleration or deferral would not result in additional tax or interest pursuant to Section 409A.

 

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10. Executive Acknowledgement.

Executive acknowledges that Executive has read and understands this Agreement, is fully aware of its legal effect, has not acted in reliance upon any representations or promises made by the Company other than those contained in writing herein, and has entered into this Agreement freely based on Executive’s own judgment.

[Signature Page Follows]

 

 

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IN WITNESS WHEREOF, the Parties have executed this Agreement on the date and year first above written.

 

HOMOLOGY MEDICINES, INC.
By:  

/s/ Albert Seymour

  Name: Albert Seymour
  Title: President and Chief Executive Officer
EXECUTIVE

/s/ Paul Alloway, Ph.D., J.D.

Paul Alloway, Ph.D., J.D.

[Signature Page to Amended and Restated Employment Agreement]


EXHIBIT A

Separation Agreement and Release

This Separation Agreement and Release (“Agreement”) is made by and between Paul Alloway, Ph.D., J.D. (“Executive”) and Homology Medicines, Inc. (the “Company”) (collectively referred to as the “Parties” or individually referred to as a “Party”). Capitalized terms used but not defined in this Agreement shall have the meanings set forth in the Employment Agreement (as defined below).

WHEREAS, the Parties have previously entered into that certain Amended and Restated Employment Agreement, effective as of November     , 2023 (the “Employment Agreement”) and that certain Nondisclosure, Nonsolicitation, and Assignment of Intellectual Property Agreement, dated as of May 4, 2020 (the “Restrictive Covenant Agreement”); and

WHEREAS, in connection with Executive’s termination of employment with the Company or a subsidiary or affiliate of the Company effective ________, 20__, the Parties wish to resolve any and all disputes, claims, complaints, grievances, charges, actions, petitions, and demands that Executive may have against the Company and any of the Releasees as defined below, including, but not limited to, any and all claims arising out of or in any way related to Executive’s employment with or separation from the Company or its subsidiaries or affiliates but, for the avoidance of doubt, nothing herein will be deemed to release any rights or remedies in connection with Executive’s ownership of vested equity securities of the Company, vested benefits or Executive’s right to indemnification by the Company or any of its affiliates pursuant to contract, insurance policy or applicable law (collectively, the “Retained Claims”).

NOW, THEREFORE, in consideration of the severance payments and benefits described in Section 4 of the Employment Agreement, which, pursuant to the Employment Agreement, are conditioned on Executive’s execution and non-revocation of this Agreement, and in consideration of the mutual promises made herein, the Company and Executive hereby agree as follows:

1. Severance Payments and Benefits; Salary and Benefits. The Company agrees to provide Executive with the severance payments and benefits described in Section 4(b) and, if applicable, Section 4(c) of the Employment Agreement, payable at the times set forth in, and subject to the terms and conditions of, the Employment Agreement. In addition, to the extent not already paid, and subject to the terms and conditions of the Employment Agreement, the Company shall pay or provide to Executive all other payments or benefits described in Section 3(c) of the Employment Agreement, subject to and in accordance with the terms thereof.

2. Release of Claims. Executive agrees that, other than with respect to the Retained Claims, the foregoing consideration represents settlement in full of all outstanding obligations owed to Executive by the Company, any of its direct or indirect subsidiaries and affiliates, and any of its or their current and former officers, directors, equityholders, managers, employees, agents, investors, attorneys, shareholders, administrators, affiliates, benefit plans, plan administrators, insurers, trustees, divisions, and subsidiaries and predecessor and successor corporations and assigns (collectively, the “Releasees”). Executive, on Executive’s own behalf and on behalf of any of Executive’s affiliated companies or entities and any of their respective heirs, family members, executors, agents, and assigns, other than with respect to the Retained Claims, hereby and forever releases the Releasees from, and agrees not to sue concerning, or in any manner to institute, prosecute, or pursue, any claim, complaint, charge, duty, obligation, or cause of action relating to any matters of any kind, whether presently known or unknown, suspected or unsuspected, that Executive may possess against any of the Releasees arising from any omissions, acts, facts, or damages that have occurred up until and including the date Executive signs this Agreement, including, without limitation:


(a) any and all claims relating to or arising from Executive’s employment or service relationship with the Company or any of its direct or indirect subsidiaries or affiliates and the termination of that relationship;

(b) any and all claims relating to, or arising from, Executive’s right to purchase, or actual purchase of any shares of stock or other equity interests of the Company or any of its affiliates, including, without limitation, any claims for fraud, misrepresentation, breach of fiduciary duty, breach of duty under applicable state law, and securities fraud under any state or federal law;

(c) any and all claims for wrongful discharge of employment; termination in violation of public policy; discrimination; harassment; retaliation; breach of contract, both express and implied; breach of covenant of good faith and fair dealing, both express and implied; promissory estoppel; negligent or intentional infliction of emotional distress; fraud; negligent or intentional misrepresentation; negligent or intentional interference with contract or prospective economic advantage; unfair business practices; defamation; libel; slander; negligence; personal injury; assault; battery; invasion of privacy; false imprisonment; conversion; and disability benefits;

(d) any and all claims for violation of any federal, state, or municipal statute, including, but not limited to, Title VII of the Civil Rights Act of 1964; the Civil Rights Act of 1991; the Rehabilitation Act of 1973; the Americans with Disabilities Act of 1990; the Equal Pay Act; the Fair Labor Standards Act; the Fair Credit Reporting Act; the Age Discrimination in Employment Act of 1967; the Older Workers Benefit Protection Act; the Employee Retirement Income Security Act of 1974; the Worker Adjustment and Retraining Notification Act; the Family and Medical Leave Act; the Sarbanes-Oxley Act of 2002; the Colorado Anti-Discrimination Act; ch. 21 of the Texas Labor Code; the Massachusetts Fair Employment Practices Act., Mass. Gen. Laws ch. 151B, § 1 et seq.; the Massachusetts Civil Rights Act, Mass. Gen. Laws ch. 12, §§ 11H and 11I; the Massachusetts Equal Rights Act, Mass. Gen. Laws. ch. 93, § 102 and Mass. Gen. Laws ch. 214, § 1C; Mass. Gen. Laws ch. 214, § 1B (Massachusetts right of privacy law); the Massachusetts Infertility Insurance Mandate, Mass. Gen. Laws ch. 175, § 47H; the Massachusetts Parental Leave Act, Mass. Gen. Laws ch. 149, § 105D, and the Massachusetts Small Necessities Leave Act, Mass. Gen. Laws ch. 149, § 52D

(e) any and all claims for violation of the federal or any state constitution;

(f) any and all claims arising out of any other laws and regulations relating to employment or employment discrimination;

(g) any claim for any loss, cost, damage, or expense arising out of any dispute over the non-withholding or other tax treatment of any of the proceeds received by Executive as a result of this Agreement;

(h) any and all claims arising out of the wage and hour and wage payments laws and regulations of the state or states in which Executive has provided service to the Company or any of its affiliates (including without limitation the Massachusetts Payment of Wages Law); and

(i) any and all claims for attorneys’ fees and costs.

 

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Executive agrees that the release set forth in this section shall be and remain in effect in all respects as a complete general release as to the matters released. This release does not release claims that cannot be released as a matter of law, including, but not limited to, Executive’s right to report possible violations of federal law or regulation to any governmental agency or entity in accordance with the provisions of and rules promulgated under Section 21F of the Securities Exchange Act of 1934 or Section 806 of the Sarbanes-Oxley Act of 2002, or any other whistleblower protection provisions of state or federal law or regulation and any right to receive an award for information provided thereunder, Executive’s right to file a charge with or participate in a charge by the Equal Employment Opportunity Commission, or any other local, state, or federal administrative body or government agency that is authorized to enforce or administer laws related to employment, against the Company for discrimination (with the understanding that Executive’s release of claims herein bars Executive from recovering such monetary relief from the Company or any Releasee in connection with any charge, investigation, or proceeding, or any related complaint or lawsuit, filed by Execute or by anyone else on Executive’s behalf before the federal Equal Employment Opportunity Commission or a comparable state or local agency for any alleged discriminatory treatment), claims for unemployment compensation or any state disability insurance benefits pursuant to the terms of applicable state law, claims to continued participation in certain of the Company’s group benefit plans pursuant to the terms and conditions of COBRA, claims to any benefit entitlements vested as the date of separation of Executive’s employment, pursuant to written terms of any employee benefit plan of the Company or its affiliates and Executive’s right under applicable law and any Retained Claims. This release further does not release claims for breach of Section 3(c) or Section 4 of the Employment Agreement.

3. Acknowledgment of Waiver of Claims under ADEA. Executive understands and acknowledges that Executive is waiving and releasing any rights Executive may have under the Age Discrimination in Employment Act of 1967 (“ADEA”), and that this waiver and release is knowing and voluntary. Executive understands and agrees that this waiver and release does not apply to any rights or claims that may arise under the ADEA after the date Executive signs this Agreement. Executive understands and acknowledges that the consideration given for this waiver and release is in addition to anything of value to which Executive was already entitled. Executive further acknowledges receipt of the disclosure set forth on Exhibit A and understands and acknowledges that Executive has been advised by this writing that: (a) Executive should consult with an attorney prior to executing this Agreement; (b) Executive has [21/45] days within which to consider this Agreement, and the Parties agree that such time period to review this Agreement shall not be extended upon any material or immaterial changes to this Agreement; (c) Executive has 7 business days following Executive’s execution of this Agreement to revoke this Agreement pursuant to written notice to [insert notice party] of the Company; (d) this Agreement shall not be effective until after the revocation period has expired; and (e) nothing in this Agreement prevents or precludes Executive from challenging or seeking a determination in good faith of the validity of this waiver under the ADEA, nor does it impose any condition precedent, penalties, or costs for doing so, unless specifically authorized by federal law. In the event Executive signs this Agreement and returns it to the Company in less than the [21/45] day period identified above, Executive hereby acknowledges that Executive has freely and voluntarily chosen to waive the time period allotted for considering this Agreement.

4. Restrictive Covenants.

(a) Executive acknowledges and agrees that the restrictive covenants and other post-termination obligations set forth in the Restrictive Covenant Agreement, including without limitation Executive’s obligations relating to confidentiality, non-use and non-disclosure of Confidential Information (as such term is defined in the Restrictive Covenant Agreement), non-solicitation, cooperation, and return of property, are hereby incorporated by reference and shall remain in full force and effect pursuant to their terms to the maximum extent permitted by applicable law. Executive represents and warrants that Executive has complied with all provisions of the Restrictive Covenant Agreement at all times through the Effective Date.

 

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(b) In consideration for the severance payments and benefits set forth in Section 1 of this Agreement, Executive agrees for a period of one year after the Effective Date (the “Non-Competition Restricted Period”) to not, directly or indirectly, on Executive’s own behalf or for the benefit of any other individual or entity other than the Company: (i) operate, conduct, or engage in, or prepare to operate, conduct, or engage in the Business (as defined below); (ii) own, finance, or invest in (except as the holder of not more than one percent of the outstanding stock of a publicly-held company) any Business; or (iii) participate in, render services to, or assist any person or entity that engages in or is preparing to engage in the Business in any capacity (whether as an employee, consultant, contractor, partner, officer, director, or otherwise) (x) which involves the same or similar types of services Executive performed for the Company at any time during the last two years of Executive’s employment with the Company or (y) in which Executive could reasonably be expected to use or disclose Proprietary Information, in each case (i), (ii) or (iii) in the Restricted Territory (as defined below); provided, that Executive’s provision of legal advice or representation that does not violate applicable rules of professional conduct shall not constitute a violation of this paragraph. Without limiting the Company’s ability to seek other remedies available in law or equity, if Executive violates this Section 4(b), the Non-Competition Restricted Period shall be extended by one day for each day that Executive is in violation of such provisions, up to a maximum extension equal to the length of the Non-Competition Restricted Period, so as to give the Company the full benefit of the bargained-for length of forbearance.

(c) Executive’s continued compliance with the terms of the Restrictive Covenant Agreement and the noncompetition obligations set forth in Section 4(b) above (collectively, the “Restrictive Covenants”) is a material condition to receipt of the severance payments and benefits set forth in Section 1 of this Agreement. In the event Executive breaches any part of such Restrictive Covenants, then, in addition to any remedies and enforcement mechanisms set forth in the Restrictive Covenant Agreement, the Employment Agreement and this Agreement, and any other remedies available to the Company (including equitable and injunctive remedies), Executive shall forfeit any additional consideration owing and shall be obligated to promptly return to the Company (within fifteen (15) business days of any breach) the full gross amount of all severance payments and benefits provided.

(d) If any provision of the Restrictive Covenants shall be determined to be unenforceable by any court of competent jurisdiction or arbitrator by reason of its extending for too great a period of time or over too large a geographic area or over too great a range of activities, it shall be interpreted to extend only over the maximum period of time, geographic area or range of activities as to which it may be enforceable.

(e) As used in this Agreement:

(i) The term “Business” means any business or part thereof that develops, manufactures, markets, licenses, sells or provides any product or service that competes with any product or service developed, manufactured, marketed, licensed, sold or provided, or planned to be developed, manufactured, marketed, licensed, sold or provided, by the Company, in each case at any time during Executive’s employment or engagement with the Company.

 

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(ii) The term “Restricted Territory” means each city, county, state, territory and country in which (i) Executive provided services or had a material presence or influence at any time during the last two years of Executive’s employment or engagement with the Company or (ii) the Company is engaged in or has plans to engage in the Business as of the termination of Executive’s employment or engagement with the Company.

5. Severability. In the event that any provision or any portion of any provision hereof or any surviving agreement made a part hereof becomes or is declared by a court of competent jurisdiction or arbitrator to be illegal, unenforceable, or void, this Agreement shall continue in full force and effect without said provision or portion of provision.

6. No Oral Modification. This Agreement may only be amended in a writing signed by Executive and a duly authorized officer of the Company.

7. Governing Law; Notices; Dispute Resolution. This Agreement shall be subject to the provisions of Sections 9(a), 9(c) and 9(h) of the Employment Agreement.

8. Effective Date. Executive has seven business days after Executive signs this Agreement to revoke it and this Agreement will become effective upon the expiration of such seven business day period (the “Effective Date”), so long as it has been signed by the Parties and has not been revoked by Executive before that date.

9. Protected Disclosures. In accordance with 18 U.S.C. §1833, notwithstanding anything to the contrary in this Agreement, the Employment Agreement, the Restrictive Covenant Agreement or any other agreement between Executive and the Company or any of its subsidiaries in effect as of the date Executive receives this Agreement (together, the “Subject Documents”): (a) Executive will not be in breach of the Subject Documents, and shall not be held criminally or civilly liable under any federal or state trade secret law (i) for the disclosure of a trade secret that is made in confidence to a federal, state, or local government official or to an attorney solely for the purpose of reporting or investigating a suspected violation of law, or (ii) for the disclosure of a trade secret that is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal; and (b) if Executive files a lawsuit for retaliation by the Company for reporting a suspected violation of law, Executive may disclose the trade secret to Executive’s attorney, and may use the trade secret information in the court proceeding, if Executive files any document containing the trade secret under seal, and does not disclose the trade secret, except pursuant to court order. Further, the Parties agree that nothing in the Subject Documents prohibits Executive from (i) communicating directly with, cooperating with, or providing information to, or receiving financial awards from, any federal, state or local government agency, including without limitation the U.S. Securities and Exchange Commission, the U.S. Commodity Futures Trading Commission, the U.S. Department of Justice, the U.S. Equal Employment Opportunity Commission, or the U.S. National Labor Relations Board, without notifying or seeking permission from the Company, or (ii) discussing or disclosing information about unlawful acts in the workplace, such as harassment or discrimination based on a protected characteristic or any other conduct that Executive has reason to believe is unlawful.

10. Voluntary Execution of Agreement. Executive understands and agrees that Executive executed this Agreement voluntarily, without any duress or undue influence on the part or behalf of the Company or any third party, with the full intent of releasing all of Executive’s claims against the Company and any of the other Releasees. Executive acknowledges that: (a) Executive has read this Agreement; (b) Executive has not relied upon any representations or statements made by the Company

 

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that are not specifically set forth in this Agreement; (c) Executive has been represented in the preparation, negotiation, and execution of this Agreement by legal counsel of Executive’s own choice or has elected not to retain legal counsel; (d) Executive understands the terms and consequences of this Agreement and of the releases it contains; and (e) Executive is fully aware of the legal and binding effect of this Agreement.

IN WITNESS WHEREOF, the Parties have executed this Agreement on the respective dates set forth below.

 

    EXECUTIVE
   

 

Dated:     Paul Alloway, Ph.D., J.D.
    HOMOLOGY MEDICINES, INC.
Dated:                                 By:  

 

     

Name:

Title:

 

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Exhibit 10.9

Employment Agreement

This Employment Agreement (this “Agreement”), dated as of November 16, 2023, is made by and between Homology Medicines, Inc., a Delaware corporation (together with any successor thereto, the “Company”), and Charles Michaud, Jr. (“Executive”) (collectively referred to herein as the “Parties” or individually referred to as a “Party”), and effective as of November 17, 2023 (the “Effective Date”).

RECITALS

 

A.

It is the desire of the Company to assure itself of the services of Executive as of the Effective Date and thereafter by entering into this Agreement.

 

B.

Executive and the Company mutually desire that Executive provide services to the Company on the terms herein provided.

AGREEMENT

NOW, THEREFORE, in consideration of the foregoing and of the respective covenants and agreements set forth below, the Parties hereto agree as follows:

 

1.

Employment.

(a) General. Effective on the Effective Date, the Company shall continue to employ Executive, and Executive shall remain employed by the Company, for the period and in the positions set forth in this Section 1, and subject to the other terms and conditions herein provided.

(b) At-Will Employment. The Company and Executive acknowledge that Executive’s employment is and shall continue to be at-will, as defined under applicable law, and that Executive’s employment with the Company may be terminated by either Party at any time for any or no reason (subject to the notice requirements of Section 3(b)). This “at-will” nature of Executive’s employment shall remain unchanged during Executive’s tenure as an employee and may not be changed, except in an express writing signed by Executive and a duly authorized officer of the Company. If Executive’s employment terminates for any reason, Executive shall not be entitled to any payments, benefits, damages, award or compensation other than as provided in this Agreement or otherwise agreed to in writing by the Company or as provided by applicable law. The term of this Agreement (the “Term”) shall commence on the Effective Date and end on the date this Agreement is terminated under Section 3.

(c) Positions and Duties. During the Term, Executive shall serve as Treasurer of the Company, with such responsibilities, duties and authority normally associated with such position and as may from time to time be assigned to Executive by the President of the Company (the “Supervisor”). Executive shall devote substantially all of Executive’s working time and efforts to the business and affairs of the Company (which shall include service to its affiliates, if applicable) and shall not engage in outside business activities (including serving on outside boards or committees) without the consent of the Board of Directors of the Company or an authorized committee of the Board (in either case, the “Board”), provided that Executive shall be permitted to (i) manage Executive’s personal, financial and legal affairs, (ii) participate in trade associations, and (iii) serve on the board of directors of not-for-profit or tax-exempt charitable organizations, in each case, subject to compliance with this Agreement and provided that such activities do not materially interfere with Executive’s performance of Executive’s duties and responsibilities hereunder. Executive agrees to observe and comply with the rules and policies of the Company as adopted by the Company from time to time, in each case, as amended from time to time, and as delivered or made available to Executive (each, a “Policy”).


2.

Compensation and Related Matters.

(a) Annual Base Salary. During the Term, Executive shall receive a base salary at a rate of $313,308 per annum, which shall be paid in accordance with the customary payroll practices of the Company and shall be pro-rated for partial years of employment. Such annual base salary shall be reviewed (and may be adjusted) from time to time by the Board (such annual base salary, as it may be adjusted from time to time, the “Annual Base Salary”).

(b) 2023 Annual Bonus; Change in Control Bonus.

(i) Executive shall receive an amount in cash equal to 50% of Executive’ target annual bonus for the Company’s 2023 fiscal year (the “2023 Annual Bonus”), payable in a lump sum payment following completion of the 2023 fiscal year, but in any event no later than March 15, 2024 The payment of the 2023 Annual Bonus shall be subject to Executive’s continued employment with the Company through the date of payment, except as otherwise provided in Section 4(b)(ii).

(ii) Subject to Executive’s continued employment through the Closing (except as otherwise expressly provided in Section 4(b)(vi) and, if applicable, Section 4(c)(i)(A)), Executive shall receive an amount in cash equal to Executive’s Annual Base Salary, multiplied by a fraction, the numerator of which is the number of days elapsed from July 27, 2023 through the date of the Closing and the denominator of which is 365, up to a maximum of cash payment equal to $182,763.00 (the “Change in Control Bonus”). The Change in Control Bonus shall be payable in a lump sum payment on the first regular payroll date of the Company that is at least five (5) business days after the Closing, in accordance with the Company’s normal payroll practices.

(c) Benefits. During the Term, Executive shall be eligible to participate in employee benefit plans, programs and arrangements of the Company (including medical, dental and 401(k) plans), subject to the terms and eligibility requirements thereof and as such plans, programs and arrangements may be amended from time to time. In no event shall Executive be eligible to participate in any severance plan or program of the Company, except as set forth in Section 4 of this Agreement.

(d) Vacation. During the Term, Executive shall be entitled to paid personal leave in accordance with the Company’s Policies. Any vacation shall be taken at the reasonable and mutual convenience of the Company and Executive.

(e) Business Expenses. During the Term, the Company shall reimburse Executive for all reasonable travel and other business expenses incurred by Executive in the performance of Executive’s duties to the Company in accordance with the Company’s expense reimbursement Policy.

(f) Key Person Insurance. At any time during the Term, the Company shall have the right (but not the obligation) to insure the life of Executive for the Company’s sole benefit. The Company shall have the right to determine the amount of insurance and the type of policy. Executive shall reasonably cooperate with the Company in obtaining such insurance by submitting to physical examinations, by supplying all information reasonably required by any insurance carrier, and by executing all necessary documents reasonably required by any insurance carrier, provided that any information provided to an insurance company or broker shall not be provided to the Company without the prior written authorization of Executive. Executive shall incur no financial obligation by executing any required document, and shall have no interest in any such policy.

 

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3. Termination. Executive’s employment hereunder and the Term may be terminated by the Company or Executive, as applicable, without any breach of this Agreement under the following circumstances and the Term will end on the Date of Termination:

 

  (a)

Circumstances.

(i) Death. Executive’s employment hereunder shall terminate upon Executive’s death.

(ii) Disability. If Executive has incurred a Disability, as defined below, the Company may terminate Executive’s employment.

(iii) Termination for Cause. The Company may terminate Executive’s employment for Cause, as defined below.

(iv) Termination without Cause. The Company may terminate Executive’s employment without Cause.

(v) Resignation from the Company with Good Reason. Executive may resign Executive’s employment with the Company with Good Reason, as defined below.

(vi) Resignation from the Company without Good Reason. Executive may resign Executive’s employment with the Company for any reason other than Good Reason or for no reason.

(b) Notice of Termination. Any termination of Executive’s employment by the Company or by Executive under this Section 3 (other than termination pursuant to Section 3(a)(i)) shall be communicated by a written notice to the other Party hereto (i) indicating the specific termination provision in this Agreement relied upon, (ii) setting forth in reasonable detail the facts and circumstances claimed to provide a basis for termination of Executive’s employment under the provision so indicated, if applicable, and (iii) specifying a Date of Termination which, if submitted by Executive, shall be at least thirty (30) days following the date of such notice (a “Notice of Termination”); provided, however, that in the event that Executive delivers a Notice of Termination to the Company, the Company may, in its sole discretion, change the Date of Termination to any date that occurs following the date of the Company’s receipt of such Notice of Termination and is prior to the date specified in such Notice of Termination, but the termination will still be considered a resignation by Executive. A Notice of Termination submitted by the Company may provide for a Date of Termination on the date Executive receives the Notice of Termination, or any date thereafter elected by the Company. The failure by either Party to set forth in the Notice of Termination any fact or circumstance which contributes to a showing of Cause or Good Reason shall not waive any right of the Party hereunder or preclude the Party from asserting such fact or circumstance in enforcing the Party’s rights hereunder.

(c) Company Obligations upon Termination. Upon termination of Executive’s employment pursuant to any of the circumstances listed in this Section 3, Executive (or Executive’s estate) shall be entitled to receive the sum of: (i) the portion of Executive’s Annual Base Salary earned through the Date of Termination, but not yet paid to Executive; (ii) any expense reimbursements owed to Executive pursuant to Section 2(e); and (iii) any amount accrued and arising from Executive’s participation in, or benefits accrued under any employee benefit plans, programs or arrangements, which amounts shall be payable in accordance with the terms and conditions of such employee benefit plans, programs or arrangements (collectively, the “Company Arrangements”). Except as otherwise expressly required by law (e.g., COBRA) or as specifically provided herein, all of Executive’s rights to salary, severance, benefits, bonuses and other compensatory amounts hereunder (if any) shall cease upon the termination of Executive’s employment hereunder. In the event that Executive’s employment is terminated by the Company for any reason, Executive’s sole and exclusive remedy shall be to receive the payments and benefits described in this Section 3(c) or Section 4, as applicable.

 

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(d) Deemed Resignation. Upon termination of Executive’s employment for any reason, Executive shall be deemed to have resigned from all offices and directorships, if any, then held with the Company or any of its subsidiaries.

 

4.

Severance Payments.

(a) Termination for Cause, or Termination Upon Death, Disability or Resignation from the Company Without Good Reason. If Executive’s employment shall terminate as a result of Executive’s death pursuant to Section 3(a)(i) or Disability pursuant to Section 3(a)(ii), pursuant to Section 3(a)(iii) for Cause, or pursuant to Section 3(a)(iv) due to Executive’s resignation from the Company without Good Reason, then Executive shall not be entitled to any severance payments or benefits, except as provided in Section 3(c).

(b) Termination without Cause, or Resignation from the Company with Good Reason. If Executive’s employment terminates without Cause pursuant to Section 3(a)(iv), or pursuant to Section 3(a)(v) due to Executive’s resignation with Good Reason (in either case, a “Qualifying Termination”), then, subject to Executive signing on or before the forty-fifth (45th) day following Executive’s Separation from Service (as defined below), and not revoking, a release of claims substantially in the form attached as Exhibit A to this Agreement (the “Release”), and Executive’s continued compliance with Section 5, Executive shall receive, in addition to payments and benefits set forth in Section 3(c), the following:

(i) an amount in cash equal to 0.75 times the Annual Base Salary, payable in the form of salary continuation in regular installments over the nine (9) month period following the date of Executive’s Separation from Service (the “Severance Period”) in accordance with the Company’s normal payroll practices;

(ii) to the extent unpaid as of the Date of Termination, the 2023 Annual Bonus shall be paid at such time that bonuses for the 2023 fiscal year are paid to actively employed employees of the Company, but in any event no later than March 15, 2024;

(iii) if Executive timely elects to receive continued medical, dental or vision coverage under one or more of the Company’s group medical, dental or vision plans pursuant to the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended (“COBRA”), then the Company shall directly pay, or reimburse Executive for, the COBRA premiums for Executive and Executive’s covered dependents under such plans, less the amount Executive would have had to pay to receive such coverage as an active employee based on the cost sharing levels in effect on the Date of Termination, during the period commencing on Executive’s Separation from Service and ending upon the earliest of (X) the last day of the Severance Period, (Y) the date that Executive and/or Executive’s covered dependents become no longer eligible for COBRA or (Z) the date Executive becomes eligible to receive medical, dental or vision coverage, as applicable, from a subsequent employer (and Executive agrees to promptly notify the Company of such eligibility). Notwithstanding the foregoing, if the Company determines in its sole discretion that it cannot provide the foregoing benefit without potentially violating applicable law (including, without limitation, Section 2716 of the Public Health Service Act) or incurring an excise tax, the Company shall in lieu thereof provide to Executive a taxable monthly payment in an amount

 

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equal to the monthly COBRA premium that Executive would be required to pay to continue Executive’s and Executive’s covered dependents’ group health coverage in effect on the Date of Termination (which amount shall be based on the premium for the first month of COBRA coverage), less the amount Executive would have had to pay to receive group health coverage as an active employee for Executive and his or her covered dependents based on the cost sharing levels in effect on the Date of Termination, which payments shall be made regardless of whether Executive elects COBRA continuation coverage and shall commence in the month following the month in which the Date of Termination occurs and shall end on the earliest of (X) the last day of the Severance Period, (Y) the date that Executive and/or Executive’s covered dependents become no longer eligible for COBRA or (Z) the date Executive becomes eligible to receive healthcare coverage from a subsequent employer (and Executive agrees to promptly notify the Company of such eligibility);

(iv) each outstanding option (“Option”) to purchase shares of the Company’s common stock that was granted to Executive under the Company’s 2018 Incentive Award Plan (the “2018 Plan”) or the Company’s 2015 Stock Incentive Plan (the “2015 Plan”) and that is vested and unexercised as of the date of Executive’s Separation from Service (each, a “Subject Option”) will remain outstanding and exercisable until the first anniversary of the date of Executive’s Separation from Service; provided, that (A) no Subject Option will remain outstanding past the final expiration date of such Subject Option set forth in the award agreement governing such Subject Option and (B) each Subject Option will in all events remain subject to earlier termination in connection with a corporate transaction or event (including the Closing (as defined below)) in accordance with the terms of the award agreement governing such Subject Option and the 2018 Plan or 2015 Plan, as applicable;

(v) the vesting of outstanding restricted stock units that were granted to Executive under the 2018 Plan that vest in annual installments based on continuous service to the Company and are unvested as of the date of Executive’s Separation from Service (“Subject RSUs”) will accelerate as to the portion of such Subject RSUs equal to, for a given award of Subject RSUs, the product of (A) the number of Subject RSUs scheduled to vest on the first annual vesting date of such award after the date of Executive’s Separation from Service multiplied by (B) a fraction, the numerator of which is the number of days elapsed since the last annual vesting date of such award (or the grant date if no vesting under such award has occurred) and the denominator of which is 365, rounded down to the nearest whole Subject RSU (the “Vested RSUs”); and

(vi) in the event such Qualifying Termination occurs prior to the Closing, an amount in cash equal to $78,327.00 (the “Partial Change in Control Bonus”), payable in a lump sum payment in accordance with the Company’s normal payroll practices.

(c) Change in Control. In the event Executive’s employment terminates due to a Qualifying Termination either (x) prior to the Closing and provided such Closing occurs during the Pre-CIC Protection Period or (y) during the Post-CIC Protection Period, then subject to Executive signing on or before the forty-fifth (45th) day following Executive’s Separation from Service, and not revoking, the Release, and Executive’s continued compliance with Section 5, Executive shall receive, in addition to the payments and benefits set forth in Section 4(b), the following:

 

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(i) if such Qualifying Termination occurs during the Pre-CIC Protection Period:

(A) if, to the reasonable satisfaction of the Company, Executive remains available from the date of Executive’s Separation from Service until the Closing to answer questions and provide transition advice to the Company relating to Executive’s former duties, area of work experience and expertise as are reasonably requested by the Company from time to time, an amount in cash equal to the excess of the Change in Control Bonus (determined in accordance with Section 2(b)(ii) (disregarding, for this purpose, the continued service requirement applicable thereunder) over the Partial Change in Control Bonus, payable in a lump sum payment in accordance with the Company’s normal payroll practices and in any event no earlier than the first regular payroll date of the Company that is at least five (5) business days after the Closing; and

(B) (I) all Subject RSUs that do not become Vested RSUs in accordance with Section 4(b)(v) and all outstanding Options that are not Subject Options shall vest upon the Closing (and for the avoidance of doubt, notwithstanding their contrary terms, shall remain outstanding and eligible to vest upon the Closing if the Closing occurs during the Pre-CIC Protection Period, and will be forfeited upon expiration of the Pre-CIC Protection Period if the Closing has not occurred or upon the earlier termination of the Merger Agreement without the Closing occurring) and (II) all outstanding Options that vest upon the Closing in accordance with this Section 4(c)(i)(B) shall remain outstanding and exercisable following vesting until the first anniversary of the date of Executive’s Separation from Service; provided, that (x) no such Option will remain outstanding past the final expiration date of such Option set forth in the award agreement governing such Option and (y) each Option will in all events remain subject to earlier termination in connection with a corporate transaction or event (including the Closing) in accordance with the terms of the award agreement governing such Subject Option and the 2018 Plan or 2015 Plan, as applicable; or

(ii) if such Qualifying Termination occurs during the Post-CIC Protection Period:

(A) all unvested equity or equity-based awards held by Executive under any Company equity compensation plans that vest solely based on the passage of time shall immediately become 100% vested (for the avoidance of doubt, with any such awards that vest in whole or in part based on the attainment of performance-vesting conditions being governed by the terms of the applicable award agreement); and

(B) all outstanding Options that vested upon the Closing in accordance with the Merger Agreement or that vest in accordance with Section 4(c)(ii)(A) shall remain outstanding and exercisable following vesting until the first anniversary of the date of Executive’s Separation from Service; provided, that (x) no such Option will remain outstanding past the final expiration date of such Option set forth in the award agreement governing such Option and (y) each Option will in all events remain subject to earlier termination in connection with a corporate transaction or event (including the Closing) in accordance with the terms of the award agreement governing such Option and the applicable Company equity compensation plan.

(d) Survival. Notwithstanding anything to the contrary in this Agreement, the provisions of Sections 5 through 9 will survive the termination of Executive’s employment and the termination of the Term.

 

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5. Restrictive Covenants. Executive previously executed and delivered to the Company a Nondisclosure, Nonsolicitation, and Assignment of Intellectual Property Agreement (the “Restrictive Covenant Agreement”). Executive acknowledges and agrees that, as a condition to the effectiveness of this Agreement, Executive continues to be bound by the terms of the Restrictive Covenant Agreement, which are hereby incorporated by reference into this Agreement. Executive acknowledges that the provisions of the Restrictive Covenant Agreement will survive the termination of Executive’s employment and the termination of the Term for the periods set forth in the Restrictive Covenant Agreement.

 

6.

Assignment and Successors.

The Company may assign its rights and obligations under this Agreement to any of its affiliates or to any successor to all or substantially all of the business or the assets of the Company (by merger or otherwise), and may assign or encumber this Agreement and its rights hereunder as security for indebtedness of the Company and its affiliates. This Agreement shall be binding upon and inure to the benefit of the Company, Executive and their respective successors, assigns, personnel and legal representatives, executors, administrators, heirs, distributees, devisees, and legatees, as applicable. None of Executive’s rights or obligations may be assigned or transferred by Executive, other than Executive’s rights to payments hereunder, which may be transferred only by will or operation of law. Notwithstanding the foregoing, Executive shall be entitled, to the extent permitted under applicable law and applicable Company Arrangements, to select and change a beneficiary or beneficiaries to receive compensation hereunder following Executive’s death by giving written notice thereof to the Company.

 

7.

Certain Definitions.

(a) Cause. The Company shall have “Cause” to terminate Executive’s employment hereunder upon:

(i) The Board’s reasonable, good faith determination that Executive has refused to (A) substantially perform the duties associated with Executive’s position with the Company or (B) carry out the reasonable and lawful instructions of the Board concerning duties or actions consistent with the Executive’s position with the Company;

(ii) Executive’s breach of a material provision of this Agreement that, to the extent capable of cure, has remained uncured for a period of thirty (30) days following written notice from the Company;

(iii) Executive’s conviction, plea of no contest, plea of nolo contendere, or imposition of unadjudicated probation for any felony or crime involving moral turpitude;

(iv) Executive’s unlawful use (including being under the influence) or possession of illegal drugs on the Company’s (or any of its affiliate’s) premises or while performing Executive’s duties and responsibilities under this Agreement; or

(v) Executive’s commission of any act of fraud, embezzlement, misappropriation, willful misconduct, or breach of fiduciary duty against the Company or any of its affiliates.

(b) Change in Control. “Change in Control” shall have the meaning set forth in the Homology Medicines, Inc. 2018 Incentive Award Plan.

(c) Closing. “Closing” means the consummation of the transactions contemplated by the Merger Agreement.

 

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(d) Code. “Code” shall mean the Internal Revenue Code of 1986, as amended, and the regulations and guidance promulgated thereunder.

(e) Date of Termination. “Date of Termination” shall mean (i) if Executive’s employment is terminated by Executive’s death, the date of Executive’s death; or (ii) if Executive’s employment is terminated pursuant to Section 3(a)(ii) – (vi) either the date indicated in the Notice of Termination or the date specified by the Company pursuant to Section 3(b), whichever is earlier.

(f) Disability. “Disability” shall mean, at any time the Company or any of its affiliates sponsors a long-term disability plan for the Company’s employees, “disability” as defined in such long-term disability plan for the purpose of determining a participant’s eligibility for benefits, provided, however, if the long-term disability plan contains multiple definitions of disability, “Disability” shall refer to that definition of disability which, if Executive qualified for such disability benefits, would provide coverage for the longest period of time. The determination of whether Executive has a Disability shall be made by the person or persons required to make disability determinations under the long-term disability plan. At any time the Company does not sponsor a long-term disability plan for its employees, “Disability” shall mean Executive’s inability to perform, with or without reasonable accommodation, the essential functions of Executive’s positions hereunder for a total of three months during any six-month period as a result of incapacity due to mental or physical illness as determined by a physician selected by the Company or its insurers and acceptable to Executive or Executive’s legal representative, with such agreement as to acceptability not to be unreasonably withheld or delayed. Any refusal by Executive to submit to a medical examination for the purpose of determining Disability shall be deemed to constitute conclusive evidence of Executive’s Disability.

(g) Good Reason. For the sole purpose of determining Executive’s right to severance payments and benefits as described above, Executive’s resignation will be with “Good Reason” if Executive resigns within ninety (90) days after any of the following events, unless Executive consents in writing to the applicable event: (i) a reduction in Executive’s Annual Base Salary or Target Annual Bonus, (ii) a material decrease in Executive’s authority or areas of responsibility as are commensurate with Executive’s title or position with the Company, (iii) the relocation of Executive’s primary office to a location more than twenty-five (25) miles from the Executive’s primary office as of the date of this Agreement or (iv) the Company’s breach of a material provision of this Agreement. Notwithstanding the foregoing, no Good Reason will have occurred unless and until Executive has: (a) provided the Company, within sixty (60) days of Executive’s knowledge of the occurrence of the facts and circumstances underlying the Good Reason event, written notice stating with specificity the applicable facts and circumstances underlying such finding of Good Reason; (b) provided the Company with an opportunity to cure the same within thirty (30) days after the receipt of such notice; and (c) the Company shall have failed to so cure within such period.

(h) Merger Agreement. “Merger Agreement” means that certain Agreement and Plan of Merger, by and among the Company, Kenobi Merger Sub, Inc. and Q32 Bio Inc., dated as of the Signing Date.

(i) Post-CIC Protection Period. “Post-CIC Protection Period” means the period beginning on the effective date of a Change in Control and ending on the date that is twelve (12) months following the date of such Change in Control.

(j) Pre-CIC Protection Period. “Pre-CIC Protection Period” means the period commencing on the Signing Date and ending on the date that is nine (9) months after the Signing Date.

 

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(k) Signing Date. “Signing Date” means the date of the Merger Agreement.

 

8.

Parachute Payments.

(a) Notwithstanding any other provisions of this Agreement or any Company equity plan or agreement, in the event that any payment or benefit by the Company or otherwise to or for the benefit of Executive, whether paid or payable or distributed or distributable pursuant to the terms of this Agreement or otherwise (all such payments and benefits, including the payments and benefits under Section 4 hereof, being hereinafter referred to as the “Total Payments”), would be subject (in whole or in part) to the excise tax imposed by Section 4999 of the Code (the “Excise Tax”), then the Total Payments shall be reduced (in the order provided in Section 8(b)) to the minimum extent necessary to avoid the imposition of the Excise Tax on the Total Payments, but only if (i) the net amount of such Total Payments, as so reduced (and after subtracting the net amount of federal, state and local income and employment taxes on such reduced Total Payments and after taking into account the phase out of itemized deductions and personal exemptions attributable to such reduced Total Payments), is greater than or equal to (ii) the net amount of such Total Payments without such reduction (but after subtracting the net amount of federal, state and local income and employment taxes on such Total Payments and the amount of the Excise Tax to which Executive would be subject in respect of such unreduced Total Payments and after taking into account the phase out of itemized deductions and personal exemptions attributable to such unreduced Total Payments).

(b) The Total Payments shall be reduced in the following order: (i) reduction on a pro-rata basis of any cash severance payments that are exempt from Section 409A of the Code (“Section 409A”), (ii) reduction on a pro-rata basis of any non-cash severance payments or benefits that are exempt from Section 409A, (iii) reduction on a pro-rata basis of any other payments or benefits that are exempt from Section 409A, and (iv) reduction of any payments or benefits otherwise payable to Executive on a pro-rata basis or such other manner that complies with Section 409A; provided, in case of clauses (ii), (iii) and (iv), that reduction of any payments attributable to the acceleration of vesting of Company equity awards shall be first applied to Company equity awards that would otherwise vest last in time.

(c) All determinations regarding the application of this Section 8 shall be made by an accounting firm or consulting group with experience in performing calculations regarding the applicability of Section 280G of the Code and the Excise Tax selected by the Company (the “Independent Advisors”). For purposes of determinations, no portion of the Total Payments shall be taken into account which, in the opinion of the Independent Advisors, (i) does not constitute a “parachute payment” within the meaning of Section 280G(b)(2) of the Code (including by reason of Section 280G(b)(4)(A) of the Code) or (ii) constitutes reasonable compensation for services actually rendered, within the meaning of Section 280G(b)(4)(B) of the Code, in excess of the “base amount” (as defined in Section 280G(b)(3) of the Code) allocable to such reasonable compensation. The costs of obtaining such determination and all related fees and expenses (including related fees and expenses incurred in any later audit) shall be borne by the Company.

(d) In the event it is later determined that a greater reduction in the Total Payments should have been made to implement the objective and intent of this Section 8, the excess amount shall be returned promptly by Executive to the Company.

 

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9.

Miscellaneous Provisions.

(a) Governing Law. This Agreement shall be governed, construed, interpreted and enforced in accordance with its express terms, and otherwise in accordance with the substantive laws of the Commonwealth of Massachusetts without reference to the principles of conflicts of law of the Commonwealth of Massachusetts or any other jurisdiction that would result in the application of the laws of a jurisdiction other than the Commonwealth of Massachusetts, and where applicable, the laws of the United States.

(b) Validity. The invalidity or unenforceability of any provision or provisions of this Agreement shall not affect the validity or enforceability of any other provision of this Agreement, which shall remain in full force and effect.

(c) Notices. Any notice, request, claim, demand, document and other communication hereunder to any Party shall be effective upon receipt (or refusal of receipt) and shall be in writing and delivered personally or sent by facsimile or certified or registered mail, postage prepaid, as follows:

(i) If to the Company, to the President of the Company at the Company’s headquarters,

(ii) If to Executive, to the last address that the Company has in its personnel records for Executive, or

(iii) At any other address as any Party shall have specified by notice in writing to the other Party.

(d) Counterparts. This Agreement may be executed in several counterparts, each of which shall be deemed to be an original, but all of which together will constitute one and the same Agreement. Signatures delivered by facsimile or PDF shall be deemed effective for all purposes.

(e) Entire Agreement. The terms of this Agreement, and the Restrictive Covenant Agreement incorporated herein by reference as set forth in Section 5, are intended by the Parties to be the final expression of their agreement with respect to the subject matter hereof and supersede all prior understandings and agreements, whether written or oral, including any prior employment offer letter or employment agreement between Executive and the Company. The Parties further intend that this Agreement shall constitute the complete and exclusive statement of their terms and that no extrinsic evidence whatsoever may be introduced in any judicial, administrative, or other legal proceeding to vary the terms of this Agreement.

(f) Amendments; Waivers. This Agreement may not be modified, amended, or terminated except by an instrument in writing, signed by Executive and a duly authorized officer of Company. By an instrument in writing similarly executed, Executive or a duly authorized officer of the Company may waive compliance by the other Party with any specifically identified provision of this Agreement that such other Party was or is obligated to comply with or perform; provided, however, that such waiver shall not operate as a waiver of, or estoppel with respect to, any other or subsequent failure. No failure to exercise and no delay in exercising any right, remedy, or power hereunder will preclude any other or further exercise of any other right, remedy, or power provided herein or by law or in equity.

(g) Construction. This Agreement shall be deemed drafted equally by both the Parties. Its language shall be construed as a whole and according to its fair meaning. Any presumption or principle that the language is to be construed against any Party shall not apply. The headings in this Agreement are only for convenience and are not intended to affect construction or interpretation. Any references to paragraphs, subparagraphs, sections or subsections are to those parts of this Agreement, unless the context clearly indicates to the contrary. Also, unless the context clearly indicates to the contrary, (i) the plural includes the singular and the singular includes the plural; (ii) “and” and “or” are each used both conjunctively and disjunctively; (iii) “any,” “all,” “each,” or “every” means “any and all,” and “each and every”; (iv) “includes” and “including” are each “without limitation”; (v) “herein,” “hereof,” “hereunder” and other similar compounds of the word “here” refer to the entire Agreement and not to any particular paragraph, subparagraph, section or subsection; and (vi) all pronouns and any variations thereof shall be deemed to refer to the masculine, feminine, neuter, singular or plural as the identity of the entities or persons referred to may require.

 

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(h) Arbitration. Any controversy, claim or dispute arising out of or relating to this Agreement, shall be settled solely and exclusively by a binding arbitration process administered by JAMS/Endispute in Boston, Massachusetts. Such arbitration shall be conducted in accordance with the then-existing JAMS/Endispute Rules of Practice and Procedure, with the following exceptions if in conflict: (i) one arbitrator who is a retired judge shall be chosen by JAMS/Endispute; (ii) each Party to the arbitration will pay one-half of the expenses and fees of the arbitrator, together with other expenses of the arbitration incurred or approved by the arbitrator; and (iii) arbitration may proceed in the absence of any Party if written notice (pursuant to the JAMS/Endispute rules and regulations) of the proceedings has been given to such Party. Each Party shall bear its own attorney’s fees and expenses; provided that the arbitrator may assess the prevailing Party’s fees and costs against the non-prevailing Party as part of the arbitrator’s award. The Parties agree to abide by all decisions and awards rendered in such proceedings. Such decisions and awards rendered by the arbitrator shall be final and conclusive. All such controversies, claims or disputes shall be settled in this manner in lieu of any action at law or equity; provided, however, that nothing in this subsection shall be construed as precluding the bringing of an action for injunctive relief or specific performance as provided in this Agreement or the Restrictive Covenant Agreement. This dispute resolution process and any arbitration hereunder shall be confidential and neither any Party nor the neutral arbitrator shall disclose the existence, contents or results of such process without the prior written consent of all Parties, except where necessary or compelled in a court to enforce this arbitration provision or an award from such arbitration or otherwise in a legal proceeding. If JAMS/Endispute no longer exists or is otherwise unavailable, the Parties agree that the American Arbitration Association (“AAA”) shall administer the arbitration in accordance with its then-existing rules as modified by this subsection. In such event, all references herein to JAMS/Endispute shall mean AAA. Notwithstanding the foregoing, Executive and the Company each have the right to resolve any issue or dispute over intellectual property rights by court action instead of arbitration.

(i) Enforcement. If any provision of this Agreement is held to be illegal, invalid or unenforceable under present or future laws effective during the Term, such provision shall be fully severable; this Agreement shall be construed and enforced as if such illegal, invalid or unenforceable provision had never comprised a portion of this Agreement; and the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid or unenforceable provision or by its severance from this Agreement. Furthermore, in lieu of such illegal, invalid or unenforceable provision there shall be added automatically as part of this Agreement a provision as similar in terms to such illegal, invalid or unenforceable provision as may be possible and be legal, valid and enforceable.

(j) Withholding. The Company shall be entitled to withhold from any amounts payable under this Agreement any federal, state, local or foreign withholding or other taxes or charges which the Company is required to withhold. The Company shall be entitled to rely on the advice of counsel if any questions as to the amount or requirement of withholding shall arise.

(k) Section 409A.

(i) General. The intent of the Parties is that the payments and benefits under this Agreement comply with or be exempt from Section 409A and, accordingly, to the maximum extent permitted, this Agreement shall be interpreted to be in compliance therewith.

 

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(ii) Separation from Service. Notwithstanding anything in this Agreement to the contrary, any compensation or benefits payable under this Agreement that is designated under this Agreement as payable upon Executive’s termination of employment shall be payable only upon Executive’s “separation from service” with the Company within the meaning of Section 409A (a “Separation from Service”). Except as provided below, and notwithstanding anything in this Agreement to the contrary, any compensation or benefits described in Section 4 shall not be paid, or, in the case of installments, shall not commence payment, until the first regular payroll date of the Company that is at least five (5) business days following the date the Release becomes effective and irrevocable in accordance with its terms or, if Executive’s Separation from Service occurs on or after November 1st of any calendar year, on the first regular payroll date of the calendar year beginning immediately after the calendar year in which Executive’s Separation from Service occurs, with the first payment to include any installments that would have been paid earlier if the Release had become effective and irrevocable on the date of Executive’s Separation from Service.

(iii) Specified Employee. Notwithstanding anything in this Agreement to the contrary, if Executive is deemed by the Company at the time of Executive’s Separation from Service to be a “specified employee” for purposes of Section 409A, to the extent delayed commencement of any portion of the benefits to which Executive is entitled under this Agreement is required in order to avoid a prohibited distribution under Section 409A, such portion of Executive’s benefits shall not be provided to Executive prior to the earlier of (i) the expiration of the six-month period measured from the date of Executive’s Separation from Service with the Company or (ii) the date of Executive’s death. Upon the first business day following the expiration of the applicable Section 409A period, all payments deferred pursuant to the preceding sentence shall be paid in a lump sum to Executive (or Executive’s estate or beneficiaries), and any remaining payments due to Executive under this Agreement shall be paid as otherwise provided herein.

(iv) Expense Reimbursements. To the extent that any reimbursements under this Agreement are subject to Section 409A, any such reimbursements payable to Executive shall be paid to Executive no later than December 31 of the year following the year in which the expense was incurred; provided that, Executive submits Executive’s reimbursement request promptly following the date the expense is incurred, the amount of expenses reimbursed in one year shall not affect the amount eligible for reimbursement in any subsequent year, other than medical expenses referred to in Section 105(b) of the Code, and Executive’s right to reimbursement under this Agreement will not be subject to liquidation or exchange for another benefit.

(v) Installments. Executive’s right to receive any installment payments under this Agreement, including without limitation any continuation salary payments that are payable on Company payroll dates, shall be treated as a right to receive a series of separate payments and, accordingly, each such installment payment shall at all times be considered a separate and distinct payment as permitted under Section 409A. Except as otherwise permitted under Section 409A, no payment hereunder shall be accelerated or deferred unless such acceleration or deferral would not result in additional tax or interest pursuant to Section 409A.

 

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10.

Executive Acknowledgement.

Executive acknowledges that Executive has read and understands this Agreement, is fully aware of its legal effect, has not acted in reliance upon any representations or promises made by the Company other than those contained in writing herein, and has entered into this Agreement freely based on Executive’s own judgment.

[Signature Page Follows]

 

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IN WITNESS WHEREOF, the Parties have executed this Agreement on the date and year first above written.

 

HOMOLOGY MEDICINES, INC.
By:  

/s/ Paul Alloway

  Name: Paul Alloway
  Title: Chief Legal Officer and Secretary
EXECUTIVE

/s/ Charles Michaud, Jr.

Charles Michaud, Jr.

[Signature Page to Employment Agreement]


EXHIBIT A

Separation Agreement and Release

This Separation Agreement and Release (“Agreement”) is made by and between Charles Michaud, Jr. (“Executive”) and Homology Medicines, Inc. (the “Company”) (collectively referred to as the “Parties” or individually referred to as a “Party”). Capitalized terms used but not defined in this Agreement shall have the meanings set forth in the Employment Agreement (as defined below).

WHEREAS, the Parties have previously entered into that certain Employment Agreement, effective as of November     , 2023 (the “Employment Agreement”) and that certain Nondisclosure, Nonsolicitation, and Assignment of Intellectual Property Agreement, dated as of May 20, 2020 (the “Restrictive Covenant Agreement”); and

WHEREAS, in connection with Executive’s termination of employment with the Company or a subsidiary or affiliate of the Company effective ________, 20__, the Parties wish to resolve any and all disputes, claims, complaints, grievances, charges, actions, petitions, and demands that Executive may have against the Company and any of the Releasees as defined below, including, but not limited to, any and all claims arising out of or in any way related to Executive’s employment with or separation from the Company or its subsidiaries or affiliates but, for the avoidance of doubt, nothing herein will be deemed to release any rights or remedies in connection with Executive’s ownership of vested equity securities of the Company, vested benefits or Executive’s right to indemnification by the Company or any of its affiliates pursuant to contract, insurance policy or applicable law (collectively, the “Retained Claims”).

NOW, THEREFORE, in consideration of the severance payments and benefits described in Section 4 of the Employment Agreement, which, pursuant to the Employment Agreement, are conditioned on Executive’s execution and non-revocation of this Agreement, and in consideration of the mutual promises made herein, the Company and Executive hereby agree as follows:

1. Severance Payments and Benefits; Salary and Benefits. The Company agrees to provide Executive with the severance payments and benefits described in Section 4(b) and, if applicable, Section 4(c) of the Employment Agreement, payable at the times set forth in, and subject to the terms and conditions of, the Employment Agreement. In addition, to the extent not already paid, and subject to the terms and conditions of the Employment Agreement, the Company shall pay or provide to Executive all other payments or benefits described in Section 3(c) of the Employment Agreement, subject to and in accordance with the terms thereof.

2. Release of Claims. Executive agrees that, other than with respect to the Retained Claims, the foregoing consideration represents settlement in full of all outstanding obligations owed to Executive by the Company, any of its direct or indirect subsidiaries and affiliates, and any of its or their current and former officers, directors, equityholders, managers, employees, agents, investors, attorneys, shareholders, administrators, affiliates, benefit plans, plan administrators, insurers, trustees, divisions, and subsidiaries and predecessor and successor corporations and assigns (collectively, the “Releasees”). Executive, on Executive’s own behalf and on behalf of any of Executive’s affiliated companies or entities and any of their respective heirs, family members, executors, agents, and assigns, other than with respect to the Retained Claims, hereby and forever releases the Releasees from, and agrees not to sue concerning, or in any manner to institute, prosecute, or pursue, any claim, complaint, charge, duty, obligation, or cause of action relating to any matters of any kind, whether presently known or unknown, suspected or unsuspected, that Executive may possess against any of the Releasees arising from any omissions, acts, facts, or damages that have occurred up until and including the date Executive signs this Agreement, including, without limitation:


(a) any and all claims relating to or arising from Executive’s employment or service relationship with the Company or any of its direct or indirect subsidiaries or affiliates and the termination of that relationship;

(b) any and all claims relating to, or arising from, Executive’s right to purchase, or actual purchase of any shares of stock or other equity interests of the Company or any of its affiliates, including, without limitation, any claims for fraud, misrepresentation, breach of fiduciary duty, breach of duty under applicable state law, and securities fraud under any state or federal law;

(c) any and all claims for wrongful discharge of employment; termination in violation of public policy; discrimination; harassment; retaliation; breach of contract, both express and implied; breach of covenant of good faith and fair dealing, both express and implied; promissory estoppel; negligent or intentional infliction of emotional distress; fraud; negligent or intentional misrepresentation; negligent or intentional interference with contract or prospective economic advantage; unfair business practices; defamation; libel; slander; negligence; personal injury; assault; battery; invasion of privacy; false imprisonment; conversion; and disability benefits;

(d) any and all claims for violation of any federal, state, or municipal statute, including, but not limited to, Title VII of the Civil Rights Act of 1964; the Civil Rights Act of 1991; the Rehabilitation Act of 1973; the Americans with Disabilities Act of 1990; the Equal Pay Act; the Fair Labor Standards Act; the Fair Credit Reporting Act; the Age Discrimination in Employment Act of 1967; the Older Workers Benefit Protection Act; the Employee Retirement Income Security Act of 1974; the Worker Adjustment and Retraining Notification Act; the Family and Medical Leave Act; the Sarbanes-Oxley Act of 2002; the Colorado Anti-Discrimination Act; ch. 21 of the Texas Labor Code; the Massachusetts Fair Employment Practices Act., Mass. Gen. Laws ch. 151B, § 1 et seq.; the Massachusetts Civil Rights Act, Mass. Gen. Laws ch. 12, §§ 11H and 11I; the Massachusetts Equal Rights Act, Mass. Gen. Laws. ch. 93, § 102 and Mass. Gen. Laws ch. 214, § 1C; Mass. Gen. Laws ch. 214, § 1B (Massachusetts right of privacy law); the Massachusetts Infertility Insurance Mandate, Mass. Gen. Laws ch. 175, § 47H; the Massachusetts Parental Leave Act, Mass. Gen. Laws ch. 149, § 105D, and the Massachusetts Small Necessities Leave Act, Mass. Gen. Laws ch. 149, § 52D

(e) any and all claims for violation of the federal or any state constitution;

(f) any and all claims arising out of any other laws and regulations relating to employment or employment discrimination;

(g) any claim for any loss, cost, damage, or expense arising out of any dispute over the non-withholding or other tax treatment of any of the proceeds received by Executive as a result of this Agreement;

(h) any and all claims arising out of the wage and hour and wage payments laws and regulations of the state or states in which Executive has provided service to the Company or any of its affiliates (including without limitation the Massachusetts Payment of Wages Law); and

(i) any and all claims for attorneys’ fees and costs.

 

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Executive agrees that the release set forth in this section shall be and remain in effect in all respects as a complete general release as to the matters released. This release does not release claims that cannot be released as a matter of law, including, but not limited to, Executive’s right to report possible violations of federal law or regulation to any governmental agency or entity in accordance with the provisions of and rules promulgated under Section 21F of the Securities Exchange Act of 1934 or Section 806 of the Sarbanes-Oxley Act of 2002, or any other whistleblower protection provisions of state or federal law or regulation and any right to receive an award for information provided thereunder, Executive’s right to file a charge with or participate in a charge by the Equal Employment Opportunity Commission, or any other local, state, or federal administrative body or government agency that is authorized to enforce or administer laws related to employment, against the Company for discrimination (with the understanding that Executive’s release of claims herein bars Executive from recovering such monetary relief from the Company or any Releasee in connection with any charge, investigation, or proceeding, or any related complaint or lawsuit, filed by Execute or by anyone else on Executive’s behalf before the federal Equal Employment Opportunity Commission or a comparable state or local agency for any alleged discriminatory treatment), claims for unemployment compensation or any state disability insurance benefits pursuant to the terms of applicable state law, claims to continued participation in certain of the Company’s group benefit plans pursuant to the terms and conditions of COBRA, claims to any benefit entitlements vested as the date of separation of Executive’s employment, pursuant to written terms of any employee benefit plan of the Company or its affiliates and Executive’s right under applicable law and any Retained Claims. This release further does not release claims for breach of Section 3(c) or Section 4 of the Employment Agreement.

3. Acknowledgment of Waiver of Claims under ADEA. Executive understands and acknowledges that Executive is waiving and releasing any rights Executive may have under the Age Discrimination in Employment Act of 1967 (“ADEA”), and that this waiver and release is knowing and voluntary. Executive understands and agrees that this waiver and release does not apply to any rights or claims that may arise under the ADEA after the date Executive signs this Agreement. Executive understands and acknowledges that the consideration given for this waiver and release is in addition to anything of value to which Executive was already entitled. Executive further acknowledges receipt of the disclosure set forth on Exhibit A and understands and acknowledges that Executive has been advised by this writing that: (a) Executive should consult with an attorney prior to executing this Agreement; (b) Executive has [21/45] days within which to consider this Agreement, and the Parties agree that such time period to review this Agreement shall not be extended upon any material or immaterial changes to this Agreement; (c) Executive has 7 business days following Executive’s execution of this Agreement to revoke this Agreement pursuant to written notice to [insert notice party] of the Company; (d) this Agreement shall not be effective until after the revocation period has expired; and (e) nothing in this Agreement prevents or precludes Executive from challenging or seeking a determination in good faith of the validity of this waiver under the ADEA, nor does it impose any condition precedent, penalties, or costs for doing so, unless specifically authorized by federal law. In the event Executive signs this Agreement and returns it to the Company in less than the [21/45] day period identified above, Executive hereby acknowledges that Executive has freely and voluntarily chosen to waive the time period allotted for considering this Agreement.

4. Restrictive Covenants.

(a) Executive acknowledges and agrees that the restrictive covenants and other post-termination obligations set forth in the Restrictive Covenant Agreement, including without limitation Executive’s obligations relating to confidentiality, non-use and non-disclosure of Confidential Information (as such term is defined in the Restrictive Covenant Agreement), non-solicitation, cooperation, and return of property, are hereby incorporated by reference and shall remain in full force and effect pursuant to their terms to the maximum extent permitted by applicable law. Executive represents and warrants that Executive has complied with all provisions of the Restrictive Covenant Agreement at all times through the Effective Date.

 

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(b) In consideration for the severance payments and benefits set forth in Section 1 of this Agreement, Executive agrees for a period of one year after the Effective Date (the “Non-Competition Restricted Period”) to not, directly or indirectly, on Executive’s own behalf or for the benefit of any other individual or entity other than the Company: (i) operate, conduct, or engage in, or prepare to operate, conduct, or engage in the Business (as defined below); (ii) own, finance, or invest in (except as the holder of not more than one percent of the outstanding stock of a publicly-held company) any Business; or (iii) participate in, render services to, or assist any person or entity that engages in or is preparing to engage in the Business in any capacity (whether as an employee, consultant, contractor, partner, officer, director, or otherwise) (x) which involves the same or similar types of services Executive performed for the Company at any time during the last two years of Executive’s employment with the Company or (y) in which Executive could reasonably be expected to use or disclose Proprietary Information, in each case (i), (ii) or (iii) in the Restricted Territory (as defined below). Without limiting the Company’s ability to seek other remedies available in law or equity, if Executive violates this Section 4(b), the Non-Competition Restricted Period shall be extended by one day for each day that Executive is in violation of such provisions, up to a maximum extension equal to the length of the Non-Competition Restricted Period, so as to give the Company the full benefit of the bargained-for length of forbearance

(c) Executive’s continued compliance with the terms of the Restrictive Covenant Agreement and the noncompetition obligations set forth in Section 4(b) above (collectively, the “Restrictive Covenants”) is a material condition to receipt of the severance payments and benefits set forth in Section 1 of this Agreement. In the event Executive breaches any part of such Restrictive Covenants, then, in addition to any remedies and enforcement mechanisms set forth in the Restrictive Covenant Agreement, the Employment Agreement and this Agreement, and any other remedies available to the Company (including equitable and injunctive remedies), Executive shall forfeit any additional consideration owing and shall be obligated to promptly return to the Company (within fifteen (15) business days of any breach) the full gross amount of all severance payments and benefits provided.

(d) If any provision of the Restrictive Covenants shall be determined to be unenforceable by any court of competent jurisdiction or arbitrator by reason of its extending for too great a period of time or over too large a geographic area or over too great a range of activities, it shall be interpreted to extend only over the maximum period of time, geographic area or range of activities as to which it may be enforceable.

(e) As used in this Agreement:

(i) The term “Business” means any business or part thereof that develops, manufactures, markets, licenses, sells or provides any product or service that competes with any product or service developed, manufactured, marketed, licensed, sold or provided, or planned to be developed, manufactured, marketed, licensed, sold or provided, by the Company, in each case at any time during Executive’s employment or engagement with the Company.

(ii) The term “Restricted Territory” means each city, county, state, territory and country in which (i) Executive provided services or had a material presence or influence at any time during the last two years of Executive’s employment or engagement with the Company or (ii) the Company is engaged in or has plans to engage in the Business as of the termination of Executive’s employment or engagement with the Company.

 

A-4


5. Severability. In the event that any provision or any portion of any provision hereof or any surviving agreement made a part hereof becomes or is declared by a court of competent jurisdiction or arbitrator to be illegal, unenforceable, or void, this Agreement shall continue in full force and effect without said provision or portion of provision.

6. No Oral Modification. This Agreement may only be amended in a writing signed by Executive and a duly authorized officer of the Company.

7. Governing Law; Notices; Dispute Resolution. This Agreement shall be subject to the provisions of Sections 9(a), 9(c) and 9(h) of the Employment Agreement.

8. Effective Date. Executive has seven business days after Executive signs this Agreement to revoke it and this Agreement will become effective upon the expiration of such seven business day period (the “Effective Date”), so long as it has been signed by the Parties and has not been revoked by Executive before that date.

9. Protected Disclosures. In accordance with 18 U.S.C. §1833, notwithstanding anything to the contrary in this Agreement, the Employment Agreement, the Restrictive Covenant Agreement or any other agreement between Executive and the Company or any of its subsidiaries in effect as of the date Executive receives this Agreement (together, the “Subject Documents”): (a) Executive will not be in breach of the Subject Documents, and shall not be held criminally or civilly liable under any federal or state trade secret law (i) for the disclosure of a trade secret that is made in confidence to a federal, state, or local government official or to an attorney solely for the purpose of reporting or investigating a suspected violation of law, or (ii) for the disclosure of a trade secret that is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal; and (b) if Executive files a lawsuit for retaliation by the Company for reporting a suspected violation of law, Executive may disclose the trade secret to Executive’s attorney, and may use the trade secret information in the court proceeding, if Executive files any document containing the trade secret under seal, and does not disclose the trade secret, except pursuant to court order. Further, the Parties agree that nothing in the Subject Documents prohibits Executive from (i) communicating directly with, cooperating with, or providing information to, or receiving financial awards from, any federal, state or local government agency, including without limitation the U.S. Securities and Exchange Commission, the U.S. Commodity Futures Trading Commission, the U.S. Department of Justice, the U.S. Equal Employment Opportunity Commission, or the U.S. National Labor Relations Board, without notifying or seeking permission from the Company, or (ii) discussing or disclosing information about unlawful acts in the workplace, such as harassment or discrimination based on a protected characteristic or any other conduct that Executive has reason to believe is unlawful.

10. Voluntary Execution of Agreement. Executive understands and agrees that Executive executed this Agreement voluntarily, without any duress or undue influence on the part or behalf of the Company or any third party, with the full intent of releasing all of Executive’s claims against the Company and any of the other Releasees. Executive acknowledges that: (a) Executive has read this Agreement; (b) Executive has not relied upon any representations or statements made by the Company that are not specifically set forth in this Agreement; (c) Executive has been represented in the preparation, negotiation, and execution of this Agreement by legal counsel of Executive’s own choice or has elected not to retain legal counsel; (d) Executive understands the terms and consequences of this Agreement and of the releases it contains; and (e) Executive is fully aware of the legal and binding effect of this Agreement.

 

A-5


IN WITNESS WHEREOF, the Parties have executed this Agreement on the respective dates set forth below.

 

      EXECUTIVE
     

 

Dated:                                   Charles Michaud, Jr.
      HOMOLOGY MEDICINES, INC.
Dated:                                  

By:                                                                                                                      

        Name:

        Title:

 

A-6

Exhibit 10.10

CONSULTING AGREEMENT

THIS CONSULTING AGREEMENT (the “Agreement”), effective as of November 17, 2023 (the “Effective Date”), is made by and between Homology Medicines, Inc., a Delaware corporation (the “Company”), and W. Bradford Smith (“Consultant”).

WHEREAS, Consultant’s employment with the Company terminated on November 17, 2023 (the “Termination Date”); and

WHEREAS, in connection with Consultant’s cessation of employment, the Company and Consultant desire to set forth the terms and conditions under which Consultant will continue to provide services to the Company following the Effective Date.

NOW, THEREFORE, in consideration of the mutual covenants and promises contained herein and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged by the parties hereto, the parties agree as follows:

1. Term. This Agreement shall commence on the Effective Date and shall continue until February 28, 2024, unless sooner terminated in accordance with the provisions of Section 4 (the “Consultation Period”).

2. Services.

2.1 During the Term, Consultant agrees to perform such consulting, advisory and related services to and for the Company as may be reasonably requested by the President of the Company from time to time and relate to Consultant’s former duties with the Company (the “Services”). Consultant will perform the Services in a timely, professional and workmanlike manner, consistent with industry standards and will comply with all applicable laws, rules and regulations in connection with Consultant’s performance of the Services hereunder. For the avoidance of doubt, the parties intend for Consultant to incur a “separation from service” within the meaning of Section 409A of the Internal Revenue Code of 1986, as amended, as of the Termination Date and, accordingly, the level of services Consultant provides hereunder will in all events be less than 20% of the average level of bona fide services performed by Consultant for the Company and its subsidiaries as an employee prior to the Termination Date.

2.2 Notwithstanding Section 2.1, the parties agree that Consultant’s performance of Services hereunder will be considered Consultant’s continued “employment” with the Company under, and within the meaning of, the Employee Proprietary Information and Inventions Assignment Agreement between the Company and Consultant dated March 18, 2018 (the “Restrictive Covenant Agreement”) such that Consultant’s obligations relating to confidentiality, non-use and non-disclosure of Proprietary Information (as defined in the Restrictive Covenant Agreement), will continue during the Consultation Period.

3. Compensation.

3.1 Consulting Fees. In consideration of the Services, Consultant shall be entitled to a consulting fee (the “Consulting Fee”) in the amount of $4,564.60 per month, payable in accordance with the Company’s regular payment practices for Company consultants. All billable Services shall be directed by the President of the Company (or his successor or designee). In addition, the Company shall reimburse Consultant for or directly pay all reasonable, approved and documented business expenses incurred by Consultant in the performance of the Services in accordance with the Company’s expense reimbursement policy.


3.2 Benefits. Consultant shall not be entitled to any benefits, coverages or privileges, including, without limitation, social security, unemployment, medical or pension payments, made available to employees of the Company by reason of Consultant’s Services under this Agreement.

3.3 Equity Awards. For purposes of any equity or equity-based awards held by Consultant, Consultant hereby agrees that Consultant’s Services will not constitute continued service to the Company and Consultant will be deemed to have a termination of service for purposes of such awards effective as of the Separation Date (which awards will, for the avoidance of doubt, remain subject to the terms of any separation and release agreement between Consultant and the Company entered into in connection with Consultant’s cessation of employment (the “Separation Agreement”)).

4. Termination. Either party may terminate this Agreement at any time by written notice upon a material breach of the Agreement by the other party that remains uncured for ten (10) days following receipt of written notice thereof. The Company may terminate this Agreement for any or no reason upon written notice to Consultant. In the event of termination under this Section 4, Consultant shall be entitled to payment hereunder for Services performed and expenses incurred prior to the effective date of termination, but shall otherwise have no further rights under this Agreement. Such payments and benefits shall constitute full settlement of any and all claims of Consultant of every description against the Company under this Agreement.

5. Cooperation. Consultant shall use Consultant’s best efforts in the performance of Consultant’s obligations under this Agreement. The Company shall provide Consultant with such access to its information and property as the Company determines is reasonably required in order to permit Consultant to perform Consultant’s obligations hereunder. Consultant shall cooperate with the Company’s personnel, shall not interfere with the conduct of the Company’s business and shall observe all rules, regulations and security requirements of the Company concerning the safety of persons and property.

6. Protected Disclosures. In accordance with 18 U.S.C. §1833, notwithstanding anything to the contrary in this Agreement or any other agreement between Consultant and the Company or any of its subsidiaries in effect as of the date of this Agreement (together, the “Subject Documents”): (a) Consultant will not be in breach of the Subject Documents, and shall not be held criminally or civilly liable under any federal or state trade secret law (i) for the disclosure of a trade secret that is made in confidence to a federal, state, or local government official or to an attorney solely for the purpose of reporting or investigating a suspected violation of law, or (ii) for the disclosure of a trade secret that is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal; and (b) if Consultant files a lawsuit for retaliation by the Company for reporting a suspected violation of law, Consultant may disclose the trade secret to Consultant’s attorney, and may use the trade secret information

 

2


in the court proceeding, if Consultant files any document containing the trade secret under seal, and does not disclose the trade secret, except pursuant to court order. Further, the parties agree that nothing in the Subject Documents prohibits Consultant from (i) communicating directly with, cooperating with, or providing information to, or receiving financial awards from, any federal, state or local government agency, including without limitation the U.S. Securities and Exchange Commission, the U.S. Commodity Futures Trading Commission, the U.S. Department of Justice, the U.S. Equal Employment Opportunity Commission, or the U.S. National Labor Relations Board, without notifying or seeking permission from the Company, or (ii) discussing or disclosing information about unlawful acts in the workplace, such as harassment or discrimination based on a protected characteristic or any other conduct that Consultant has reason to believe is unlawful.

7. Other Agreements. Consultant hereby represents that Consultant is not bound by the terms of any agreement with any prior employer or other party to refrain from using or disclosing any trade secret or confidential or proprietary information in the course of Consultant’s relationship with the Company, to refrain from competing, directly or indirectly, with the business of such employer or any other party or to refrain from soliciting employees, customers or suppliers of such employer or other party. Consultant agrees to furnish the Company with a copy of any such agreement upon request.

8. Survival. Notwithstanding anything to the contrary, the application of the Restrictive Covenant Agreement, as provided in Section 2.2 hereof, and any non-competition covenants set forth in the Separation Agreement (the “Restrictive Covenants”) will survive termination of this Agreement and upon expiration of this Agreement for any reason, the obligations of Consultant shall continue under the Restrictive Covenant Agreement and the Restrictive Covenants in accordance with their terms.

9. Independent Contractor Status. Consultant and the Company acknowledge and agree that, during the Consultation Period, Consultant shall provide the Services as an independent contractor. If, during the Consultation Period, Consultant is reclassified by a state or federal agency or court as an employee, Consultant will become a reclassified employee and will receive no benefits except those mandated by state or federal law, even if by the terms of the Company’s benefit plans in effect at the time of such reclassification Consultant would otherwise be eligible for such benefits. During the Consultation Period and thereafter, Consultant shall not be an agent or employee of the Company and shall not be authorized to act on behalf of the Company. Payments due to Consultant hereunder shall not be subject to withholding except as required by law and Consultant shall be responsible for Consultant’s own tax liabilities.

10. Notices. All notices required or permitted under this Agreement shall be in writing and shall be deemed effective upon personal delivery, upon transmission by electronic mail or upon deposit in the United States Post Office, by registered or certified mail, postage prepaid, addressed to the other party as follows: (i) if to the Company, then to the attention of the Company’s President at the Company’s headquarters, (ii) if to Consultant, then to Consultant’s last known address shown in the Company’s personnel records, or (iii) at such other address or addresses as either party shall designate to the other in accordance with this Section 10.

 

3


11. Pronouns. Whenever the context may require, any pronouns used in this Agreement shall include the corresponding masculine, feminine or neuter forms, and the singular forms of nouns and pronouns shall include the plural, and vice versa.

12. Entire Agreement. This Agreement constitutes the entire agreement between the parties and supersedes all prior agreements and understandings, whether written or oral, relating to the subject matter of this Agreement; provided, for the avoidance of doubt, that nothing in this agreement supersedes the Restrictive Covenant Agreement or the Separation Agreement, each of which shall remain in full force and effect.

13. Amendment. This Agreement may be amended or modified only by a written instrument executed by both the Company and Consultant.

14. Governing Law. This Agreement shall be construed, interpreted and enforced in accordance with the internal laws of the Commonwealth of Massachusetts (without giving effect to any conflicts of laws principles that would result in the application of the law of any other jurisdiction).

15. Successors and Assigns. This Agreement shall be binding upon, and inure to the benefit of, both parties and their respective successors and assigns, including without limitation any corporation with which, or into which, the Company may be merged or which may succeed to its assets or business, provided, however, that the obligations of Consultant are personal and shall not be assigned by Consultant.

16. Miscellaneous.

16.1 No delay or omission by the Company in exercising any right under this Agreement shall operate as a waiver of that or any other right. A waiver or consent given by the Company on any one occasion shall be effective only in that instance and shall not be construed as a bar or waiver of any right on any other occasion.

16.2 The captions of the sections of this Agreement are for convenience of reference only and in no way define, limit or affect the scope or substance of any section of this Agreement.

16.3 In the event that any provision of this Agreement shall be invalid, illegal or otherwise unenforceable, the validity, legality and enforceability of the remaining provisions shall in no way be affected or impaired thereby.

16.4 This Agreement may be executed in multiple counterparts by facsimile or other reliable electronic reproduction (including, without limitation, transmission by pdf), each of which shall be taken together as one and the same instrument.

[Signature Page Follows]

 

 

4


IN WITNESS WHEREOF, the parties hereto have executed this Consulting Agreement as of the date set forth above.

 

HOMOLOGY MEDICINES, INC.
By:  

/s/ Paul Alloway, Ph.D., J.D.

Name: Paul Alloway, Ph.D., J.D.
Title: Chief Legal Officer and Secretary
CONSULTANT:

/s/ W. Bradford Smith

Print Name: W. Bradford Smith

[Signature Page to Consulting Agreement]

Exhibit 10.36

Confidential

Execution Version

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,

MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND IS

THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL

 

 

 

ASSET PURCHASE AGREEMENT

by and between

Q32 BIO INC.

and

HORIZON THERAPEUTICS IRELAND DAC

Dated as of August 12, 2022

 

 

 


TABLE OF CONTENTS

 

          Page  

1.

  

DEFINITIONS

     1  

2.

  

PURCHASE AND SALE OF ASSETS

     18  
  

2.1

  

Acquired Assets

     18  
  

2.2

  

Assumed Liabilities

     19  
  

2.3

  

Excluded Liabilities

     20  
  

2.4

  

Assets Incapable of Transfer

     20  

3.

  

CONSIDERATION

     20  
  

3.1

  

Consideration

     20  
  

3.2

  

Closing Payments

     20  
  

3.3

  

Milestone and Royalty Consideration

     21  
  

3.4

  

Withholding

     26  
  

3.5

  

Post-Closing Operations

     26  

4.

  

CLOSING

     28  
  

4.1

  

Closing

     28  
  

4.2

  

Deliveries at Closing

     28  
  

4.3

  

Possession

     29  

5.

  

REPRESENTATIONS AND WARRANTIES

     29  
  

5.1

  

Representations and Warranties of Seller

     29  
  

5.2

  

Representations and Warranties of Purchaser

     42  

6.

  

ADDITIONAL AGREEMENTS

     44  
  

6.1

  

Public Disclosures

     44  
  

6.2

  

Confidentiality

     44  
  

6.3

  

Conduct Pending the Closing

     44  
  

6.4

  

Filings, Consents and Approvals

     44  
  

6.5

  

Further Assurances and Cooperation; Non-Compete

     46  
  

6.6

  

Tax Matters

     48  
  

6.7

  

Employee Matters

     49  
  

6.8

  

Escrow Agent

     49  

 

-i-


TABLE OF CONTENTS

(continued)

 

          Page  

7.

  

CONDITIONS PRECEDENT TO OBLIGATIONS OF PURCHASER

     50  

7.1

  

Accuracy of Representations and Warranties

     50  
  

7.2

  

Performance of Covenants

     50  
  

7.3

  

No Restraints

     50  
  

7.4

  

Antitrust Approvals

     50  
  

7.5

  

No Material Adverse Effect

     50  
  

7.6

  

Third Party Consents

     50  
  

7.7

  

No Governmental Litigation

     50  
  

7.8

  

Closing Certificate

     51  
  

7.9

  

Option Exercise Notice

     51  
  

7.10

  

Related Agreements

     51  

8.

  

CONDITIONS PRECEDENT TO OBLIGATION OF SELLER

     51  
  

8.1

  

Accuracy of Representations

     51  
  

8.2

  

Performance of Covenants

     51  
  

8.3

  

No Restraints

     51  
  

8.4

  

Antitrust Approvals

     51  
  

8.5

  

Closing Certificate

     51  
  

8.6

  

Option Exercise Notice

     51  
  

8.7

  

Related Agreements

     51  

9.

  

INDEMNIFICATION

     51  
  

9.1

  

Indemnification by Seller and Purchaser

     51  
  

9.2

  

Survival

     53  
  

9.3

  

Limitations

     53  
  

9.4

  

Right to Set-Off

     55  
  

9.5

  

Resolution of Indemnification Disputes

     55  
  

9.6

  

Third Party Claim Procedures

     56  
  

9.7

  

Tax Treatment of Indemnification Payments

     58  

10.

  

TERMINATION

     58  
  

10.1

  

Automatic Termination

     58  
  

10.2

  

Termination of the Agreement

     58  
  

10.3

  

Effect of Termination

     59  

 

-ii-


TABLE OF CONTENTS

(continued)

 

          Page  

11.

  

MISCELLANEOUS

     59  
  

11.1

  

Governing Law; Dispute Resolution

     59  
  

11.2

  

Specific Performance

     59  
  

11.3

  

WAIVER OF JURY TRIAL

     60  
  

11.4

  

Entire Agreement; Severability

     60  
  

11.5

  

Incorporation by Reference

     60  
  

11.6

  

Amendments and Waivers

     60  
  

11.7

  

Notices

     60  
  

11.8

  

No Assignment; Binding Effect

     61  
  

11.9

  

Third Person Beneficiaries

     62  
  

11.10

  

Relationship of the Parties

     62  
  

11.11

  

Headings; Interpretation

     62  
  

11.12

  

Counterparts; Signatures

     62  
  

11.13

  

Expenses

     62  

 

-iii-


Confidential

ASSET PURCHASE AGREEMENT

This ASSET PURCHASE AGREEMENT (this “Agreement”) is made as of August 12, 2022 (the “Agreement Date”), by and between Q32 BIO INC. (f/k/a Admirx, Inc.), a Delaware corporation, (“Seller”), and HORIZON THERAPEUTICS IRELAND DAC, an Irish company, with its principal place of business located at 70 St. Stephen’s Green, Dublin 2, D02 E2X4, Ireland (“Purchaser”). Seller and Purchaser are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.

RECITALS

A. Concurrent with the execution and delivery of this Agreement, Purchaser and Seller are entering into a Collaboration and Option Agreement (as may be amended from time-to-time, the “Collaboration Agreement”).

B. At such time, if any, that Purchaser validly exercises the Option in accordance with the Collaboration Agreement, the Parties intend to provide for the purchase by Purchaser of the Acquired Assets, including the assumption of certain Liabilities relating to the Acquired Assets, all on the terms and subject to the conditions set forth in this Agreement.

C. Subject to, and in accordance with, this Agreement, the Parties desire to enter into (i) an Assignment and Assumption Agreement, (ii) a Bill of Sale and (iii) a Transition Services Agreement.

NOW, THEREFORE, in consideration of the premises and of the respective representations, warranties, covenants, agreements, and conditions contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound hereby, the Parties agree as follows:

AGREEMENT

1. DEFINITIONS.

In this Agreement and any Exhibit, Disclosure Schedule, and Schedule attached hereto, the following terms have the meanings specified or referred to in this Section 1 and shall be equally applicable to both the singular and plural forms.

“Abbreviated Application” means (a) a Biologics License Application submitted to the FDA under subsection (k) of Section 351 of the Public Health Service Act (PHSA) (42 USC 262(k)), (b) an abbreviated New Drug Application submitted to the FDA under Section 505(j) of the FDC Act (21 USC 355(j)), or (c) any analogous application to those applications set forth in clauses (a) or (b) submitted to a Regulatory Authority outside the United States.

“Acquired Assets” has the meaning set forth in Section 2.1(a).

“Acquired Business Contracts” has the meaning set forth in Section 2.1(a)(ii).

“Acquiring Parties” has the meaning set forth in Section 6.5(c)(ii).

 

1


Confidential

 

“Action” means any lawsuit, claim, hearing, enforcement, audit, investigation, lawsuit, action (including arbitration or mediation) or other regulatory, quasi-judicial, or judicial proceeding.

“Affiliate” means, as to any Person, any other Person that, directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with that Person, but only for so long as such control exists. For purposes of this definition, “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”), as used with respect to any Person or group of Persons, means possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of the Person, whether (a) through direct or indirect beneficial ownership of at least 50% (or such lesser percentage which is the maximum allowed to be owned by a foreign entity in a particular jurisdiction) of the voting stock or other ownership interest in such corporation or other entity, or (b) by contract.

“Agreement” has the meaning set forth in the preamble.

“Allocation Schedule” has the meaning set forth in Section 6.6(a).

“Annual Net Sales” has the meaning set forth in Section 3.3(e)(i).

“Antibody” means any antibody or antigen binding fragment thereof (including any bispecific or multispecific antibody, single chain antibody or domain antibody) and/or similar antigen binding protein, whether polyclonal, monoclonal, human, humanized, chimeric, murine, synthetic or from any other source.

“Anti-Corruption Laws” shall mean the Foreign Corrupt Practices Act of 1977, as amended, the Anti-Kickback Act of 1986 or any applicable Laws of similar effect, and the related regulations and published interpretations thereunder.

“Antitrust Laws” means the Sherman Act, as amended, the Clayton Act, as amended, the HSR Act, the Federal Trade Commission Act, as amended, state antitrust laws, and all other applicable Laws and regulations (including non-U.S. laws and regulations) issued by a Governmental Authority that are designed or intended to preserve or protect competition, prohibit and restrict agreements in restraint of trade or monopolization, attempted monopolization, restraints of trade and abuse of a dominant position, or to prevent acquisitions, mergers or other business combinations and similar transactions, the effect of which may be to lessen or impede competition or to tend to create or strengthen a dominant position or to create a monopoly.

“Assignment Agreements” means any agreement with Third Parties (other than an Inventor) assigning right, title, or interest to Seller Patents.

“Assignment and Assumption Agreement” means the Assignment and Assumption Agreement in substantially the form attached hereto as Exhibit A.

“Bill of Sale” means the Bill of Sale in substantially the form attached hereto as Exhibit B.

“BMS” means Bristol-Myers Squibb Company or its successors or assigns to the BMS License.

 

2


Confidential

 

“BMS License” means the License Agreement dated September 14, 2019 between Seller and BMS, as amended by Amendment 1 to License Agreement, dated as of August 13, 2021, as amended by Second Amendment to License Agreement, dated as of July 26, 2022, as amended by Third Amendment to License Agreement, dated as of July 26, 2022.

“Business Day” means any day that is not a Saturday, a Sunday or other day on which banks are required or authorized by Law to be closed in Ireland, the State of Illinois or the State of Massachusetts.

“Change in Control” means with respect to a Party, (a) a merger, consolidation, reorganization, amalgamation, arrangement, share exchange, tender or exchange offer, private purchase, business combination or other transaction of such Party with a Third Party that results in the voting securities of such Party outstanding immediately prior thereto, or any securities into which such voting securities have been converted or exchanged, ceasing to represent more than 50% of the combined voting power of the surviving entity or the parent of the surviving entity immediately after such merger or consolidation, (b) a transaction or series of related transactions in which a Third Party, together with its Affiliates, becomes the direct or indirect beneficial owner of more than 50% of the combined voting power of the outstanding securities of such Party, or (c) the sale or other transfer to a Third Party of all or substantially all of the assets of such Party and its direct and indirect subsidiaries; provided that a sale of securities for bona fide fundraising purposes shall not be deemed a Change in Control for purposes of this Agreement.

“Claim” means a claim for Losses.

“Claim Notice” means a written notice given by an Indemnified Party to the Indemnifying Party that the Indemnified Party is proposing a claim made in good faith.

“Closing” has the meaning set forth in Section 4.1.

“Closing Date” has the meaning set forth in Section 4.1.

“Closing Payment” means (a) $[***], plus (b) any portion of the Development Funding that is to be paid at Closing pursuant to the terms of the Collaboration Agreement, less (c) the Escrow Amount, less (d) the [***], to the extent not paid by Seller to BMS at or prior to Closing.

“Code” means the Internal Revenue Code of 1986, as amended.

“Combination Product” has the meaning set forth in Section 3.3(e)(ii).

“Commercialization” means the conduct of all activities undertaken in preparation for and following Regulatory Approval relating to the promotion, sales (including receiving, accepting, and filling product orders), marketing, and distribution (including importing, exporting, transporting, customs clearance, warehousing, invoicing, handling, and delivering) of a product, including sales force detailing, advertising, market research, market access (including price and reimbursement activities) and sales force training. “Commercialize” and “Commercializing” have correlative meanings.

“Company Delivery Period” has the meaning set forth in the Collaboration Agreement.

 

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“Competitive Activities” means discovery, research, development or commercialization activities with respect to any Antibody that acts through, and is designed to specifically bind to and inhibit either [***], in either case ((a) or (b)), as its primary mechanism of action.

“Compound” has the meaning set forth in the Collaboration Agreement.

“Confidential Information” has the meaning set forth the Collaboration Agreement.

“Confidentiality Agreements” has the meaning set forth the Collaboration Agreement.

“Conflict” has the meaning set forth in Section 5.1(c).

“Consideration” has the meaning set forth in Section 3.1.

“Contagion Event” means the outbreak, escalation or worsening of contagious disease, epidemic or pandemic (including the escalation or worsening of COVID-19).

“Contract” means any written or oral contract or agreement, including supply contracts, licenses, binding commitments, customer agreements, subcontracts, leases of personal property, notes, guarantees, pledges, and conditional sales agreements to which the Person referred to is a party or by which any of its assets are bound.

“Control” or “Controlled by” means, with respect to any Intellectual Property, the possession by a party of the ability (whether by ownership, license or other right) to grant access to, or a license or sublicense of, such Intellectual Property without violating the terms of any agreement or other arrangement with any Third Party. Notwithstanding the foregoing, following the Effective Date (as defined in the Collaboration Agreement) of the Collaboration Agreement, any Intellectual Property (including Patents) owned or licensed by a Third Party prior to the date that such Third Party becomes an Affiliate of a Party pursuant to a Change in Control shall be excluded from the definition of rights “Controlled” by such Party and its Affiliates on and after the date of consummation of such transaction, except to the extent such Intellectual Property (a) was Controlled by such Party immediately prior to the consummation of such Change in Control or (b) is used by or on behalf of such Party or such Affiliate after the consummation of such Change in Control in the Development, manufacture, use, Commercialization or other exploitation of any Compound or Product in any country or jurisdiction.

“Controlled Group” means Seller and any trade or business, whether or not incorporated, which is treated together with Seller as a single employer under Section 4001(b)(1) of ERISA or Sections 414(b), (c), (m), or (o) of the Code.

“Cover”, “Covering”, or “Covered” means, with respect to a product, technology, process, method, or mode of administration that, in the absence of ownership of or a license granted under a particular Patent, the manufacture, use, offer for sale, sale, or importation of such product or the practice of such technology, process, method, or mode of administration would infringe one or more Valid Claims of such Patent or, in the case of a claim in a pending patent application, would infringe such claim if it were to issue and become a Valid Claim.

 

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“Development” means all development activities for a pharmaceutical or biological product (whether alone or for use together, or in combination, with another active ingredient as a combination product or combination therapy) that are directed to obtaining Regulatory Approval(s) of such product and lifecycle management of such product in any country in the world, including all non-clinical, preclinical, and clinical studies and trials of such product; toxicology, pharmacokinetic, and pharmacological studies; statistical analyses; assay development; protocol design and development; the preparation, filing, and prosecution of any Regulatory Approval Application for such product; development activities directed to label expansion and/or obtaining Regulatory Approval for one or more additional indications following initial Regulatory Approval; development activities conducted after receipt of Regulatory Approval; and all regulatory affairs related to any of the foregoing. “Develop” and “Developing” have correlative meanings.

“Development Funding” has the meaning set forth in the Collaboration Agreement.

“Diligent Efforts” means, with respect to the efforts to be expended by Purchaser with respect to any objective, activity or decision to be undertaken under this Agreement with respect to the Development of a Product (including obtaining Regulatory Approval(s) for such Product), on a country-by-country basis, the carrying out of such Development activities with a level of effort and resources consistent with the commercially reasonable practices typically devoted by Purchaser and its Affiliates, including Horizon Therapeutics plc, for the Development of a pharmaceutical or biologic product at a similar stage of development, and of similar scientific data and validation, market potential, profit potential and strategic value and based on conditions then prevailing. Such efforts may take into account, without limitation, scientific data (including safety and efficacy data), Regulatory Authority-approved labeling, product profile, the competitiveness of alternative products, pricing and reimbursement for such Product in a country relative to other markets, the likely timing of such Product’s entry into the market, the proprietary position of such Product, the anticipated profitability of such Product and the other products in Purchaser’s and its Affiliates’ portfolio, including Horizon Therapeutics plc’s portfolio (including other products under development), the likelihood of Regulatory Approval and other relevant scientific, technical and commercial factors.

“Disclosure Schedules” has the meaning set forth in Section 5.1.

“DOJ” means the Antitrust Division of the U.S. Department of Justice.

“Domain Names” means domain names, uniform resource locators, and applications or registrations for the foregoing.

“EMA” means the European Medicines Agency or any successor agency thereto, the European Commission (or any successor agency thereto) or any other Regulatory Authority responsible for Regulatory Approval of biological products in the European Union.

“Employee Benefit Plan” means (i) all “employee benefit plans” (as defined in Section 3(3) of ERISA), (ii) all other employee benefit plans, policies, agreements or arrangements, (iii) all employment, individual consulting, executive compensation, or other compensation agreements, or bonus or other incentive compensation, stock purchase, equity or equity-based compensation, deferred compensation, change in control, retention, severance, sick leave,

 

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vacation, recreation, retirement, pension, loans, salary continuation, health, medical, dental, vision, accident, disability, cafeteria, life insurance and educational assistance plans, policies, agreements or arrangements, and (iv) any collective bargaining agreement or union contract, in each case, whether written or unwritten and whether or not subject to ERISA, that are sponsored or maintained by Seller or any member of the Controlled Group for the benefit of current or former employees or current or former consultants, independent contractors or directors of Seller or any of its subsidiaries or with respect to which Seller or any of its subsidiaries has any Liability.

“Employee Liabilities” means any and all Liabilities, whenever or however arising, including all costs and expenses relating thereto arising under Contract, Law or Permit, Order or any award of any arbitrator of any kind relating to any Employee Benefit Plan, employment agreement, natural person consulting or independent contractor agreement, or otherwise relating to an employee or other natural person service provider and his or her potential or actual service or employment with Seller or any member of the Controlled Group.

“Enforceability Exception” has the meaning set forth in Section 5.1(b).

“Escrow Agent” means an escrow agent reasonably acceptable to Purchaser and Seller.

“Escrow Amount” means US$[***].

“Excluded Assets” has the meaning set forth in Section 2.1(b).

“Excluded Liabilities” means all Liabilities of Seller and its Affiliates not expressly included in the definition of Assumed Liabilities, including:

(a) all Liabilities arising from Seller’s ownership or use of the Acquired Assets or the conduct of its business, including the Product Operations, prior to Closing;

(b) all Liabilities relating to Excluded Assets;

(c) all Seller Tax Liabilities;

(d) all Liabilities of Seller or any of its Affiliates for product liability, infringement, or misappropriation arising from preclinical or clinical trials of a Product or Product Operations conducted by or for Seller prior to Closing;

(e) all Employee Liabilities;

(f) any Liabilities that arose or were incurred under any Acquired Business Contract prior to Closing or that relate to any failure to perform, improper performance, warranty or other breach, default, or violation by Seller as of or prior to the Closing;

(g) all Liabilities for invoices, bills, accounts payable, or other trade payables due or owned by Seller or any of its Affiliates to any Third Party relating to or arising from the Development, Commercialization, manufacture (or having manufactured) of a Compound or Product prior to the Closing;

 

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(h) any Liability arising out of or resulting from non-compliance with any Law by Seller or its Affiliates with respect to the Product Operations or the Acquired Assets prior to the Closing; and

(i) any Liability of Seller or its Affiliates to pay any fees or commissions to any broker, finder, or agent with respect to this Agreement or any of the Transactions or the consummation thereof.

“Executives” has the meaning set forth in the Collaboration Agreement.

“Exercise Withdrawal Notice” has the meaning set forth in the Collaboration Agreement.

“FDA” means the U.S. Food and Drug Administration, or any successor agency thereto.

“FDC Act” means the U.S. Federal Food, Drug, and Cosmetic Act of 1938, as amended, and the regulations promulgated thereunder from time to time.

“First Commercial Sale” has the meaning set forth in Section 3.3(e)(i).

“Fraud” means an act in the making of a specific representation or warranty expressly set forth in this Agreement or the Collaboration Agreement, committed by the Party making such express representation or warranty, with intent to deceive another Party and requires (a) an intentional false representation of material fact; (b) actual knowledge that such representation is false, or reckless indifference to its truth; (c) a specific intention to induce the Party to whom such representation was made to act or refrain from acting in reliance upon it; (d) such Party to reasonably rely upon such false representation to take or refrain from taking action; and (e) such Party suffers damage by reason of such reliance.

“FTC” means the U.S. Federal Trade Commission or any successor agency thereto.

“Fundamental Representations” means the representations and warranties contained in Sections 5.1(a) (Organization and Existence), 5.1(b) (Authority and Approval), 5.1(c) (No Conflict), 5.1(e) (Taxes), 5.1(f) (Title), and 5.1(n) (No Brokers).

“GAAP” means U.S. generally accepted accounting principles, consistently applied by the relevant Person and its Affiliates.

“GCP” has the meaning set forth in the Collaboration Agreement.

“Generic Versions” has the meaning set forth in Section 3.3(f)(iii).

“GLP” has the meaning set forth in the Collaboration Agreement.

“GMP” has the meaning set forth in the Collaboration Agreement.

“Governmental Authority” means any United States federal, state, local, or any non-U.S. government, governmental, regulatory (including self-regulatory) or administrative authority, body, agency or commission or any court, tribunal, or judicial or arbitral body.

 

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“HSR Act” means the Hart-Scott Rodino Antitrust Improvements Act of 1976, as amended, and rules and regulations promulgated thereunder.

“IND” means an investigational new drug application relating to a Product (including any amendment or supplement thereto) submitted to the FDA pursuant to 21 CFR Part 312, or a comparable application submitted to the applicable Regulatory Authority outside the United States (including as applicable clinical trial applications (CTAs), clinical trial exemptions (CTXs), and investigational medicinal product dossiers), including any supplements and amendments thereto.

“Indemnified Party” means any Party entitled to indemnification hereunder.

“Indemnifying Party” means the Party from whom indemnification is claimed.

“Indication” has the meaning set forth in Section 3.3(b)(i).

“Initiation” has the meaning set forth in Section 3.3(b)(ii).

“Intellectual Property” means any and all of the following and any and all rights associated with the following, in any jurisdiction throughout the world, by whatever name or term known or designated, whether arising by operation of Law, Contract, or otherwise:

(a) Patents;

(b) Trademarks;

(c) Domain Names;

(d) all copyrights, mask work rights, moral rights, and common-law rights thereto, and all applications, registrations, and renewals in connection therewith throughout the world;

(e) all rights in databases and data collections;

(f) all Know-How;

(g) all similar, corresponding, or equivalent rights to any of the foregoing anywhere in the world;

(h) all inventions existing in any of the foregoing; and

(i) all rights to sue for past, present, or future infringement, violations, or misappropriation of any of the foregoing anywhere in the world.

“Inventor” means each of the named inventors of each of Seller Patents, as well as any inventor who should be or should have been named on each of Seller Patents.

“Inventor Assignment Agreement” means an agreement by Seller or its Affiliate with the respective Inventor assigning all right, title, and interest to Seller Patents to Seller or its Affiliates. For clarity, any agreement with an employee or contractor of Seller or its Affiliate that provides for the general assignment of inventions made in the course of employment by or providing services to Seller or its Affiliate shall not be an “Inventor Assignment Agreement”.

 

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“Inventory” means all inventories of active pharmaceutical ingredient for the Compounds and Products, all drug product for the Compounds and Products, all raw and pack materials, workin-process, finished goods, Products on stability, warehoused stock, supplies and packaging materials relating to the manufacturing of any Product, in each case to the extent owned or controlled by Seller or its Affiliates.

“IP Representations” means those representations and warranties of Seller set forth in Section 5.1(m) (Intellectual Property).

“Irish Allocation Schedule” has the meaning set forth in Section 6.6(a).

“JSC” has the meaning set forth in the Collaboration Agreement.

“Know-How” means data, knowledge, trade secrets, know-how, discoveries, inventions and technical, business or other proprietary information, including materials, samples, manufacturing data, chemistry, manufacturing, and controls information, toxicological data, pharmacological data, data from preclinical, clinical or non-clinical testing or studies, assays, processes, protocols, procedures, methods, devices, designs, results, technology, platforms, formulations, regulatory filings, applications, approvals and associated correspondence, specifications, quality control testing data, customer lists, mailing lists and business plans.

An individual shall be deemed to have “Knowledge” of a particular fact or other matter if (a) such individual is actually aware of such fact or other matter or (b) a prudent individual would be expected to discover or otherwise become aware of such fact or other matter in the course of conducting a reasonably diligent investigation, including reasonable inquiry with relevant employees, consultants and advisors, if any, who would reasonably be expected to have knowledge of the matters in question. Seller shall be deemed to have “Knowledge” of a particular fact or other matter if any executive officer of Seller, including the Chief Executive Officer, the Chief Financial Officer, the Chief Scientific Officer, the Chief Medical Officer, the Vice President of Clinical Development Operations and Senior Director, Global Manufacturing (or such individuals in similarly equivalent roles), has Knowledge of such fact or other matter.

“Laws” means any United States federal, state and local, and any non-U.S., laws, statutes, regulations, rules, codes or ordinances enacted, adopted, issued or promulgated by any Governmental Authority or common law, including GCP, GMP and GLP.

“Legal Proceeding” shall mean any action, suit, charge, complaint, litigation, arbitration, proceeding (including any civil, criminal, administrative, investigative or appellate proceeding), hearing, inquiry, audit, examination or investigation commenced, brought, conducted or heard by or before, or otherwise involving, any court or other Governmental Authority or any arbitrator or arbitration panel.

 

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“Liability” means, with respect to any Person, any debt, duty, liability or obligation of any kind (whether known or unknown, contingent, accrued, due or to become due, secured or unsecured, matured or otherwise), including accounts payable, royalties payable, and other reserves, accrued bonuses and commissions, accrued vacation and any other form of leave, termination payment obligations, employee expense obligations, and all other liabilities and obligations of such Person or any of its subsidiaries or Affiliates, regardless of whether such debts, duties, liabilities or obligations are required to be reflected on a balance sheet in accordance with GAAP.

“License Grants” means licenses, sublicenses, or other Contracts (whether royalty bearing or non-royalty bearing) under which rights in any Product IP have been granted to any Person by any of (a) Seller, (b) any Affiliate, and (c) any other Person that, at the time of the execution of the license, sublicense, or other Contract, as applicable, is or was an Affiliate of Seller.

“Lien” means any lien, statutory lien, pledge, mortgage, security interest, Claim, encumbrance, restriction on use or transfer, easement, right of way, option, conditional sale, or other title retention agreement of any kind or nature. In the case of an Intellectual Property Right that is subject to any in-license or out-license, “Lien” includes the terms and conditions of such in-license or out-license, as applicable.

“Look-Back Date” means the date that is [***] prior to the Agreement Date.

“Losses” means any damages, losses, expenses, costs, settlement payments, awards, judgments, fines or penalties, including reasonable attorneys’ fees and any amount payable as Taxes, except to the extent incurred or paid in connection with a Third Party Claim, “Losses” shall not include any diminution in value, lost profits, lost business opportunity or unforeseeable, exemplary, punitive, speculative, special, indirect or consequential damages.

“MAA” means a marketing authorization application filed for Regulatory Approval in the European Union, Japan or other countries, of the applicable Product.

“MAA Approval” means Regulatory Approval by the EMA of an MAA (including an Abbreviated Application) filed with the EMA for the applicable Product under the centralized European procedure; provided, that MAA Approval shall in any event be deemed achieved upon First Commercial Sale in any country in the European Union.

“made available” means that Seller has provided (or made available in the virtual data room hosted on behalf of Seller) to Purchaser that material in question, (a) with respect to material existing as of the Agreement Date, before the second Business Day prior to the Agreement Date, or (b) with respect to material not yet existing as of the Agreement Date, on or before the Schedule Delivery Date, other than, in each case, material that was delivered (or made available in the virtual data room hosted on behalf of Seller) to Purchaser following such time at the request of Purchaser or the Representatives of Purchaser.

“Master Cell Bank” means the master cell bank used by Seller in connection with the manufacture of the Compound.

“Material Adverse Effect” means any event, change, circumstance, occurrence, effect, result, or state of facts that, individually or in the aggregate, (i) is or would reasonably be expected to be materially adverse to the Acquired Assets, taken as a whole or (ii) materially impairs the ability of Seller to consummate, or prevents or materially delays, the Closing or would reasonably

 

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be expected to do so, provided, however, that none of the following will constitute a Material Adverse Effect, or will be considered in determining whether a Material Adverse Effect has occurred: (a) changes that are the result of factors generally affecting the industries or markets in which Seller operates; (b) any adverse change, effect or circumstance arising out of the announcement of the Transactions (other than of purposes of any representation or warranty contained in Section 5.1(c)), including losses or threatened losses of, or any adverse change in the relationship with, customers, suppliers, distributors, financing sources, licensors, licensees or others having relationships with Seller; (c) changes in Law or GAAP or the interpretation thereof including any Laws or actions taken by any Governmental Authority newly enacted for, relating to or arising out of efforts to address the spread of any Contagion Event; (d) changes that are the result of economic factors affecting the national, regional or world economy or financial or securities markets; (e) any earthquake, hurricane, tsunami, tornado, flood, mudslide, wild fire or other natural disaster or act of god, and other force majeure event including any Contagion Event; (f) any national or international political or social conditions in any jurisdiction in which Seller conducts business; and (g) the engagement by the United States in hostilities or the escalation thereof, whether or not pursuant to the declaration of a national emergency or war, or the occurrence or the escalation of any military or terrorist attack upon the United States, or any United States territories, possessions or diplomatic or consular offices or upon any United States military installation, equipment or personnel; except in each case of clauses (a) and (c) through (g), with respect to Seller, to the extent disproportionately affecting Seller relative to other similarly situated companies in the industries in which Seller operates.

“Milestone Event” has the meaning set forth in Section 3.3(a).

“Milestone Obligor” means each of (a) Purchaser or any of its subsidiaries or Affiliates, or (b) any (sub)licensee, assignee, or any other Person who has acquired, through license or otherwise, applicable Product IP from any of the Persons set forth in clause (a) and assumed responsibility or been delegated responsibility or granted rights under the Product IP to Develop or Commercialize any Product, but excluding any contract manufacturer of a Product or other contractor, or other service provider that is providing services ancillary to Development or Commercialization of Products on behalf of Purchaser or any of its subsidiaries or Affiliates.

“Milestone Payment” has the meaning set forth in Section 3.3(a).

“NDA” means a new drug application filed with the FDA required for marketing approval for the applicable Product in the U.S., or, if the Compound is a biologic, a biologics license application (BLA) filed with the FDA required for marketing approval for the applicable Product in the U.S.

“Net Sales” has the meaning set forth in Section 3.3(b)(iii).

“Nondisclosure Agreements” means any nondisclosure, confidentiality, or similar agreements in effect as of the date of this Agreement to which Seller is a party that primarily relate to the Acquired Assets or any Product IP, or any other Compound or Product.

“Non-Scheduled License Grants” has the meaning set forth in Section 5.1(m)(ii).

“Non-Transferable Assets” has the meaning set forth in Section 2.4.

 

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“Objection Deadline” has the meaning set forth in Section 9.5(a).

“Objection Notice” has the meaning set forth in Section 9.5(a).

“Option” has the meaning set forth in the Collaboration Agreement.

“Option Exercise Notice” has the meaning set forth in the Collaboration Agreement.

“Option Termination Date” has the meaning set forth in the Collaboration Agreement.

“Order” means and includes any writ, law, rule, regulation, executive order or decree, judgment, injunction, ruling, or other order, whether temporary, preliminary, or permanent enacted, issued, promulgated, enforced, or entered into by any Governmental Authority.

“Ordinary Course of Business” means, as of a particular time, the ordinary course of business of Seller consistent with Seller’s past custom and practice.

“Organizational Document” means (a) the articles or certificate of incorporation, association, or formation and the bylaws of a corporation; (b) operating agreement, limited liability company agreement, or similar document governing a limited liability company; (c) any charter or similar document adopted or filed in connection with the creation, formation, or organization of a Person; and (d) any amendment to any of the foregoing.

“Party” and “Parties” have the meaning set forth in the preamble.

“Patent Documents” means all (a) prosecution files and docketing reports for each of Seller Patents and any other Product Patents for which Seller or its Affiliate is responsible for prosecution and maintenance; (b) Assignment Agreements and all Inventor Assignment Agreements; (c) documents, records, and files in the possession and Control of Seller, or in the Control of Seller and in the possession of its counsel, or its agents (and including any and all of each Inventor) directly related to (i) the conception and reduction to practice (and diligence in reduction to practice) of the inventions of any of Seller Patents, or (ii) the filing, prosecution, registration, continuation, continuation-in-part, reissuance, correction, enforcement, defense, and maintenance of Seller Patents and any other Product Patents for which Seller or its Affiliate is responsible for prosecution and maintenance; and (d) all other material documentation or information in the possession and Control of Seller or its Affiliates, or in the Control of Seller or its Affiliates and in the possession of its or their counsel or agents, in each case to the extent directly related to the Product Patents.

“Patents” means (a) patents and patent applications, and (b) all divisionals, continuations, continuations-in-part thereof or any other patent application claiming priority directly or indirectly to (i) any of the patents or patent applications in subsection (a), or (ii) any patent or patent application from which the patents or patent applications in (a) claim direct or indirect priority, (c) all patents issuing on any of the foregoing in (a)-(b), (d) all foreign counterparts of any of the foregoing in (a)-(c), including PCT Applications, and (e) all registrations, reissues, reexaminations, supplemental protection certificates, or extensions of any of the foregoing in (a)- (d).

 

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“PCT Applications” means any Patent applications filed under the Patent Cooperation Treaty.

“Permits” means any license, permit, registration, listing, approval, qualification, letter, authorization, certificate of authority, qualification, notice, clearance, franchise, NDA, MAA IND, or similar document or authority issued or granted by any Regulatory Authority or pursuant to any Law.

“Permitted Liens” means (a) landlords’, materialmen’s, mechanics’, carriers’, workmen’s, warehousemen’s, repairmen’s and other like Liens arising in the ordinary course of business or deposits to obtain the release of such Liens; (b) Liens for Taxes and other governmental charges and assessments which are not yet due and payable or are being contested in good faith; (c) purchase money or equipment Liens incurred in the ordinary course of business; and (d) other Liens or imperfections on property which do not adversely affect title to, detract from the value of, or impair the existing use of, the property affected by such Lien or imperfection.

“Person” means any individual, corporation, partnership, joint venture, limited liability company, association, joint-stock company, trust, unincorporated organization or Governmental Authority.

“[***]” means the milestone payment due to BMS upon the achievement of the [***] (as each such term is defined in the BMS License).

“Phase 3 Clinical Trial” has the meaning set forth in Section 3.3(b)(iv).

“PMDA” means the Japanese Pharmaceuticals and Medical Devices Agency or its successor, in Ministry of Health, Labour and Welfare.

“PMDA Approval” means Regulatory Approval by the PMDA of an MAA (including an Abbreviated Application) filed with the PMDA for the applicable Product in Japan.

“Preexisting Affiliate” means, with respect to a Party that is subject to a Change in Control, any Affiliate of such Party or the Acquiring Party following such Change in Control that was an Affiliate of such Party prior to such Change in Control.

“Pre-Existing Competitive Activities” has the meaning set forth in Section 6.5(c)(ii).

“Proceeding” means any suit, Claim, complaint, investigation, litigation, audit, proceeding, or arbitration by or before any Person.

“Product” has the meaning set forth in the Collaboration Agreement.

“Product Employees” has the meaning set forth in Section 6.7.

“Product IP” means any and all (a) Product Patents, (b) Product Know-How and (c) other Intellectual Property Controlled by Seller or any of its Affiliates that primarily relates to any Compounds or Products but excluding (i) Domain Names and (ii) Trademarks.

 

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“Product Know-How” means all Know-How Controlled by Seller or any of its Affiliates as of the Closing Date that is used or held for use in, is necessary or reasonably useful for, or was generated in, the Product Operations, including, for the avoidance of doubt, Know-How Controlled by Seller and its Affiliates, made before the Closing Date that constitutes the composition of matter of any Compound or Product, or a method of manufacturing or using any Compound or Product.

“Product Operations” means the research, Development, manufacture, formulation, testing, use, distribution, marketing, sale, promotion, and other Commercialization and exploitation of any Compound or Product as conducted by Seller and its Affiliates, and any Affiliates of Seller as conducted prior to the Closing (except as expressly provided elsewhere in this Agreement).

“Product Patents” means each of the following, whether or not pending, issued, expired, withdrawn, rejected, canceled, abandoned, or closed: (a) the Patent applications and Patents listed on Schedule I, and (b) all divisionals, continuations, continuations-in-part thereof or any other patent application claiming priority directly or indirectly to (i) any of the patents or patent applications in subsection (a), or (ii) any patent or patent application from which the patents or patent applications in (a) claim direct or indirect priority, (c) all patents issuing on any of the foregoing in (a)-(b), (d) all foreign counterparts of any of the foregoing in (a)-(c), including PCT Applications, and (e) all registrations, reissues, re-examinations, supplemental protection certificates, or extensions of any of the foregoing in (a)-(d).

“Purchaser Indemnified Parties” has the meaning set forth in Section 9.1(a).

“Q32 Australia” means Q32 Bio Australia Pty Ltd, a Subsidiary of Seller organized under the laws of Australia.

“Regulatory Approval” means, with respect to any Product in any regulatory jurisdiction, approval from the applicable Regulatory Authority for the manufacture, distribution, use, marketing, and sale of the Product in such jurisdiction in accordance with applicable Laws provided, however that for purposes of the U.S., Regulatory Approval means NDA Approval, for purposes of the European Union, Approval means MAA Approval and for purposes of Japan, Regulatory Approval means PMDA Approval.

“Regulatory Approval Application” means an application submitted to the applicable Regulatory Authority in pursuit of receiving Regulatory Approval of a Product in a country, regulatory jurisdiction or region, and all amendments and supplements thereto.

“Regulatory Authority” means any applicable Governmental Authority with jurisdiction or authority over the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale, or other commercialization of pharmaceutical or biologic products in a given country or regulatory jurisdiction, including the FDA in the United States.

“Regulatory Documentation” means all books, records, files, documents, information and correspondence of Seller or its Affiliates to the extent (a) relating to the Compounds, Products, Acquired Assets, or Assumed Liabilities, (b) used or held for use in the Product Operations, or (c) generated in the conduct of the Product Operations, including to the extent applicable (i) all records with respect to supply sources with respect to the Compounds or Products or materials used in

 

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their manufacture; (ii) all market research data, market intelligence reports, statistical programs (if any) used for marketing and sales research with respect to the Products; (iii) promotional, advertising and marketing materials, sales forecasting models, medical education materials, sales training materials, web site content, and advertising and display materials relating to the Products; (iv) all records, including vendor and supplier lists, manufacturing records, sampling records, standard operating procedures and batch records, related to the manufacturing process for any Compounds or Products; (v) all data contained in laboratory notebooks to the extent relating to any Compounds or Products or the biological, physiological, mechanical or formula properties of any of the foregoing; (vi) all adverse experience reports and files related thereto (including source documentation) and all periodic adverse experience reports and all data contained in electronic data bases relating to periodic adverse experience reports with respect to any Compounds or Products; (vii) all analytical and quality control data relating to any Compounds or Products; and (viii) all correspondence, minutes, and other communications with the FDA or any other Regulatory Authority relating to any Compounds or Product, in each case owned or held by Seller or any of its Affiliates as of or prior to the Closing. For the avoidance of doubt, Regulatory Documentation shall not include any Excluded Assets.

“Regulatory Exclusivity” has the meaning set forth in Section 3.3(e)(iv).

“Regulatory Filings” means any and all regulatory applications, filings, approvals and associated correspondence required or related to the Development, manufacture or Commercialization of any Compound or Product in any country or jurisdiction, including any INDs or equivalent applications filed with the FDA, EMA or PMDA.

“Related Agreements” means the Bill of Sale, Assignment and Assumption Agreement, the Transition Services Agreement, Escrow Agreement, and the Confidentiality Agreements and any agreement, document, or instrument entered into or delivered in connection with this Agreement and the Transactions.

“Representatives” shall mean officers, directors, employees, agents, attorneys, accountants, advisors and representatives of a Person.

“Royalties” has the meaning set forth in Section 3.3(c).

“Royalty Term” has the meaning set forth in Section 3.3(d).

“Schedule Delivery Date” has the meaning set forth in Section 5.1.

“Seller” has the meaning set forth in the preamble.

“Seller Group” shall mean Seller, Q32 Australia and any other company which is or becomes, directly or indirectly, a Subsidiary of Seller.

“Seller Indemnified Parties” has the meaning set forth in Section 9.1(b).

“Seller IP” means any and all (a) Product Patents owned by Seller or its Affiliate, (b) Product Know-How owned by Seller or its Affiliate and (c) other Intellectual Property (including any Domain Names or Trademarks) owned by Seller or any of its Affiliates that primarily relates to any Compounds or Products.

 

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“Seller Patents” means any and all Product Patents owned by Seller or its Affiliate.

“Seller Tax Liabilities” means (i) all Taxes of Seller or its Affiliates, or for which Seller or any of its Affiliates is or are liable (including as a transferee or successor, or by contract or otherwise by operation of Law), for any taxable period (including any Tax of Seller or any of its Affiliates that becomes a Liability of Purchaser under any common law doctrine of de facto merger or transferee or successor liability or otherwise by operation of contract or Law), (ii) any Taxes of another Person that Seller is liable for (including under Treasury Regulation Section 1.1502-6 or any similar provision of state, local or non-U.S. applicable Law) as a result of being a member of an affiliated, consolidated, combined or unitary group for Tax purposes on or before the Closing Date or any similar provision of state, local or foreign applicable Law, (iii) any Taxes that arise out of the Transaction contemplated by this Agreement (including withholding Taxes imposed on payments under this Agreement (except as provided in Section 3.4 of this Agreement) and [***]% of any Transfer Taxes pursuant to Section 6.6(c)), (iv) any Taxes relating to the Excluded Assets or Excluded Liabilities for any taxable period; (v) all Taxes relating to the Acquired Assets or the Assumed Liabilities for any Pre-Closing Tax Period, including the portion of any Straddle Period ending on the Closing Date as determined by Section 6.6(b) and (vi) any Later Imposed Withholding.

“Straddle Period Tax” has the meaning set forth in Section 6.6(a).

“Settled Claims” has the meaning set forth in Section 9.5(c).

“Subsidiary” shall mean with respect to any Person, any other Person (a) of which the initial Person directly or indirectly owns or controls more than 50% of the voting equity interests or has the power to elect or direct the election of a majority of the members of the governing body of such Person or (b) which is required to be consolidated with such Person under GAAP.

“Tax” or “Taxes” means any and all federal, provincial, territorial, state, municipal, local, foreign or other taxes (including imposts, rates, levies, assessments, and other charges, in each case in the nature of a tax), including all income, excise, franchise, gains, capital, real property, goods and services, transfer, value added, gross receipts, windfall profits, severance, ad valorem, personal property, production, sales, use, license, stamp, documentary stamp, mortgage recording, employment, payroll, social security, unemployment, disability, estimated or withholding taxes, and all customs and import duties, together with all interest, penalties and additions to tax (and additional amounts imposed with respect to such amounts).

“Tax Contest” has the meaning set forth in Section 6.6(e).

“Tax Return” means all U.S. federal, state, local, provincial and non-U.S. returns, declarations, claims for refunds, forms, statements, reports, schedules, information returns or similar statements or documents and any amendments thereof (including any related or supporting information or schedule attached thereto) filed or required to be filed with any applicable Governmental Authority in connection with the determination, assessment or collection of any Tax.

 

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“Third Party” means any Person other than a Party or an Affiliate of a Party.

“Third Party Claim” has the meaning set forth in Section 9.6(a).

“Third Party Licenses” has the meaning set forth in Section 3.3(f).

“Third Party Notice” has the meaning set forth in Section 9.6(a).

“Trademarks” means trademarks, trade names, corporate names, service marks, brand names, logos, trade dress, slogans, and other indicia of source or origin together with all translations, adaptations, derivations, and including all goodwill associated with the foregoing and all common-law rights thereto, as well as all applications, registrations and renewals in connection therewith.

“Transactions” means the transactions contemplated pursuant to this Agreement, and the other Related Agreements, including the Closing of the transactions contemplated by this Agreement.

“Transfer Taxes” has the meaning set forth in Section 6.6(b).

“Transferred Permits” has the meaning set forth in Section 5.1(h).

“Transferring Employees” has the meaning set forth in Section 6.7.

“Transition Services Agreement” means the Transition Services Agreement in substantially the form attached hereto as Exhibit C.

“Unanimous Matter” has the meaning set forth in the Collaboration Agreement.

“Unobjected Claim” has the meaning set forth in Section 9.5(b).

“Update Report” has the meaning set forth in Section 3.5(c).

“U.S.” means the United States of America and its territories and possessions.

“U.S. Allocation Schedule” has the meaning set forth in Section 6.6(a).

“Valid Claim” means a claim of (i) an issued and unexpired patent or a supplementary protection certificate, which claim has not been held invalid or unenforceable by a court or other government agency of competent jurisdiction from which no appeal can be or has been taken and has not been held or admitted to be invalid or unenforceable through re-examination or disclaimer, opposition procedure, nullity suit or otherwise, or (ii) a pending patent application that has not been finally abandoned, finally rejected or expired; provided, however, that if a claim of a pending patent application shall not have issued within five years (or in Japan or Canada, seven years) after the earliest filing date from which such claim takes priority, such claim shall not constitute a Valid Claim for the purposes of this Agreement unless and until a patent issues with such claim.

“VAT” means value added tax, sales taxes, consumption taxes and other similar taxes imposed or required by applicable Law.

 

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“Withholding Action” means (i) a permitted assignment of this Agreement (in whole or in part) by Purchaser to any person outside of the United States or Ireland; (ii) the exercise by Purchaser of its rights under this Agreement (in whole or in part) through any person outside of the United States or Ireland (or the direct exercise of such rights by an Affiliate of such party outside of the United States or Ireland); and (iii) a redomiciliation of Purchaser, an assignee or a successor to a jurisdiction outside the United States or Ireland.

2. PURCHASE AND SALE OF ASSETS.

2.1 Acquired Assets.

(a) Purchase and Sale. In the event that Purchaser exercises the Option, Seller shall cause to be sold, transferred and conveyed to Purchaser, at the Closing, all of Seller’s right, title and interest at the Closing in the Acquired Assets, free and clear of all Liens other than Permitted Liens, upon the terms and subject to the conditions set forth in this Agreement. At the Closing, the sale, transfer, conveyance, assignment, and delivery of the Acquired Assets will be effected pursuant to the Assignment and Assumption Agreement and the Bill of Sale. Notwithstanding anything to the contrary contained in this Agreement, the transfer of the Acquired Assets will not include the assumption by Purchaser of any Liability of the Seller Group related to the Acquired Assets, unless Purchaser expressly assumes that Liability as an Assumed Liability pursuant to Section 2.2. “Acquired Assets” shall mean the following properties, assets, and rights of the Seller Group:

(i) all Seller IP together with (A) any and all goodwill symbolized thereby and associated therewith, (B) any and all rights to royalties, profits, compensation, license payments, and other payments or remuneration of any kind relating to the Acquired Assets, and (C) any and all rights to obtain renewals, reissues, reexaminations, supplemental examinations and certificates and extensions of registrations, exclusivities, or other legal protections directly related to Seller IP and all Patent Documents;

(ii) all rights in, to, and under the Contracts listed on Schedule 2.1(a)(ii) (including the BMS License (to the extent that the BMS License has not been novated to Purchaser prior to the Closing, in which case the BMS License will not be deemed an Acquired Business Contract) and any additional Contracts listed on Schedule 2.1(a)(ii)) as updated by Seller and delivered to Purchaser at least four Business Days prior to the anticipated Closing Date, in each case for which true, correct, and complete copies have been made available to Purchaser (collectively, the “Acquired Business Contracts”); provided that if the BMS License is an Acquired Business Contract, Purchaser shall deliver the required written notice to BMS in accordance with Section 15.4.2 of the BMS License, provided further that Purchaser shall have the right to reject inclusion of (i) any Contracts listed on Schedule 2.1(a)(ii) as of the Agreement Date, (ii) any Contracts proposed to be listed on the updated Schedule 2.1(a)(ii) or (iii) any Contracts listed on Schedule 2.1(a)(ii) that were materially amended, or under which material rights were waived, after the Agreement Date;

(iii) all Inventory;

 

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(iv) all Regulatory Filings and other Regulatory Documentation, including all copies thereof;

(v) all non-clinical, laboratory, research, preclinical, and clinical trial data, files, and other documentation (including plans, reports and records, in draft and final form) relating to any Compounds or Products, Acquired Assets, and Assumed Liabilities, including all data in the Option Package (as defined in the Collaboration Agreement) and all results of analyses or studies conducted under the Development Plan (as defined in the Collaboration Agreement), and any materials used in connection therewith, including all raw data relating to any such studies, all case report forms relating thereto, all statistical programs developed (or modified in a manner to the use or function thereof) to analyze such data, and all investigator brochures for such studies;

(vi) all cell lines and cell media (and any licenses necessary or reasonably useful therefor) for all Compounds, including the [***] (as defined in the BMS License) from [***] or Affiliates thereof expressing the Compound and the [***] and related materials manufactured by [***] or Affiliates thereof used for the Compound and including the right to use the BMS cell lines and cell media used in the manufacturing of the Compound;

(vii) all chemical or biological materials relating to the Compounds or Products or used in the development or manufacturing activities under the Collaboration Agreement that are owned or held by the Seller Group or their Affiliates;

(viii) the Master Cell Bank;

(ix) all rights, Claims, credits, guaranties, warranties, indemnities, causes of action or rights of set-off, and other similar rights against Third Parties to the extent primarily relating to or arising from the Acquired Assets or the Assumed Liabilities; and

(x) any equipment owned by the Seller Group or their Affiliates and used primarily in the Development or Manufacturing of the Compounds or Products, including any equipment set forth on Schedule 2.1(a)(x) (and any additional equipment listed on Schedule 2.1(a)(x) as updated by Seller and delivered to Purchaser prior to the anticipated Closing Date).

(b) Seller and Purchaser expressly agree and acknowledge that Purchaser is not acquiring any right, title, or interest in any assets that are not Acquired Assets (collectively, the “Excluded Assets”).

2.2 Assumed Liabilities. Upon the terms and subject to the conditions of this Agreement, at the Closing, Purchaser will assume and agree to pay, perform, and discharge only those Liabilities that are Assumed Liabilities. The assumption of the Assumed Liabilities by Purchaser will be effected pursuant to the Assignment and Assumption Agreement. For purposes of this Agreement, “Assumed Liabilities” shall mean only the following liabilities of the Seller Group:

(a) all Liabilities of the Seller Group and their Affiliates under the Acquired Business Contracts arising on or after the Closing Date, including any Liabilities imposed by applicable Law with respect to obligations under any Acquired Business Contract (but excluding (i) Liabilities resulting from any breach of or non-compliance with any such Acquired Business Contract by the Seller Group or any of their Affiliates as of or prior to the Closing Date or (ii) Seller Tax Liabilities); and

 

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(b) any Liabilities arising on or after the Closing Date under the BMS License (to the extent the BMS License has not been novated to Purchaser prior to the Closing including, if not paid by Seller to BMS at or prior to Closing, Liabilities with respect to the [***]).

2.3 Excluded Liabilities. The Parties acknowledge and agree that Purchaser will not, and in no event will Purchaser assume or be required to pay, perform, or discharge any Liabilities other than the Assumed Liabilities, and that, as between the Parties, Seller shall remain responsible for all Excluded Liabilities.

2.4 Assets Incapable of Transfer. Notwithstanding anything herein to the contrary, this Agreement will not constitute (a) an assignment or transfer of, (b) an attempted assignment or transfer of, or (c) an agreement to effect an assignment or transfer of Acquired Assets, in each case ((a)-(c)), that are not assignable or transferable without the consent of another Person (that has not been obtained prior to Closing) (the “Non-Transferable Assets”), if such assignment or transfer, attempted assignment or transfer, or agreement would constitute a breach of any Acquired Business Contract in the absence of such consent. For clarity, all known Non-Transferable Assets, if any, shall be listed in Section 2.4 of the Disclosure Schedules. For a period of [***] following the Closing Date, Seller will, at no cost to Purchaser, use commercially reasonable efforts to obtain the consent of such other Person to the assignment or transfer of any such Non-Transferable Asset to Purchaser in all cases in which such consent is required for such assignment or transfer. Purchaser will reasonably cooperate with Seller in its efforts to obtain such consents; provided, without limiting the generality of the foregoing, the beneficial interest in and to the Acquired Assets, to the fullest extent permitted by the relevant Contract or Permit and applicable Law, will pass to Purchaser as of the Closing Date.

3. CONSIDERATION.

3.1 Consideration. In consideration for the purchase and sale of the Acquired Assets, subject to the Closing and the terms and conditions set forth herein, Purchaser shall pay the Consideration. The “Consideration” means the sum of (a) the Closing Payment, (b) the Milestone Payments, (c) the Royalties, (d) any disbursements to Seller from the Escrow Amount and (e) the Assumed Liabilities; provided, in the case of clauses (b), (c) and (d), such payments shall be made only when and to the extent they are payable pursuant to the terms of this Agreement and in the case of clause (d), pursuant to the terms of the Escrow Agreement.

3.2 Closing Payments.

(a) At the Closing, Purchaser shall pay (or cause to be paid) to Seller the Closing Payment in immediately available funds, by wire transfer to one or more accounts provided to Purchaser by Seller prior to the Closing.

(b) At the Closing, Purchaser shall deposit the Escrow Amount with the Escrow Agent to be held by the Escrow Agent pursuant to the terms and conditions of an escrow agreement by and among Purchaser, Seller and the Escrow Agent, in a form reasonably acceptable to Purchaser and Seller (the “Escrow Agreement”).

 

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(c) At the Closing, Purchaser shall assume and agree, on and after the Closing Date, to pay, perform and discharge promptly and fully when due the Assumed Liabilities.

(d) All payments due under this Agreement are exclusive of VAT. If any VAT is chargeable in respect of amounts payable pursuant to this Agreement, VAT shall be charged at the applicable rate required by applicable Law and the party making such payment shall pay the VAT amount on receipt of a VAT invoice in the appropriate form.

3.3 Milestone and Royalty Consideration.

(a) Milestone Payments. Subject to Closing and the other applicable terms and conditions of this Agreement, from and after the Closing, when an event set forth in the table below is achieved by the first Product to achieve such event (each such event, a “Milestone Event”), Purchaser shall pay (or cause to be paid) to Seller, in accordance with and subject to the terms of this Agreement, the one-time, non-refundable, non-creditable payment equal to the corresponding amount of “Development Milestone Payment Payable to Seller” set forth in the table below (each such payment, a “Milestone Payment”), or such amounts as may otherwise be agreed by Purchaser and Seller pursuant to Section 3.3(j):

 

Development Milestone Event    Development Milestone Payment
payable to Seller
 

[***]

   $ [***]  

[***]

   $ [***]  

[***]

   $ [***]  

Total

   $ [***]  

Each of the Milestone Payments shall be payable only one time, for the first achievement of the corresponding Milestone Event, and no Milestone Payments would be due for subsequent or repeated achievements of the same Milestone Event, whether by the same Product or a different Product. Each Milestone Payment shall be paid within [***] after the achievement of the corresponding Milestone Event. The aggregate amount of Milestone Payments payable by Purchaser to Seller shall in no event exceed $[***].

(b) Selected Definitions.

(i) “Indication” means any separately defined, well-categorized class of human disease, syndrome or medical condition for which a separate Regulatory Approval Application is required to be filed with a Regulatory Authority. For clarity, (A) approval for the treatment and prevention of the same disease, syndrome or medical condition are the same Indication, except where the applicable patient population is materially expanded by virtue of such approval, in which case the approval for such treatment or prevention will be deemed to be a new Indication, and (B) the approved use in a different line of treatment or a different temporal position for the same disease, syndrome or medical condition (e.g., first line vs. second line therapy for the same disease) are the same Indication.

 

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(ii) “Initiation” means, when used with respect to a Clinical Trial, upon the dosing of the first patient with the first dose in such Clinical Trial.

(iii) “Phase 2 Clinical Trial” means a Clinical Trial of a Product, including a separate Clinical Trial or the second part of a fused “Phase 1/2” Clinical Trial, on a sufficient number of subjects that is designed to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population.

(iv) “Phase 3 Clinical Trial” means a Clinical Trial of a Product, including a separate Clinical Trial or the second part of a fused “Phase 2/3” Clinical Trial, that is designed to establish that a pharmaceutical or biological product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such pharmaceutical or biological product in the dosage range and dose duration to be prescribed, which trial is intended to support Regulatory Approval of a Product. “Clinical Trial” means any human clinical study of a pharmaceutical or biological product.

(c) Royalties. Subject to Closing and the other applicable terms and conditions of this Agreement, during the Royalty Term, on a Product-by-Product and country-by-country basis, Purchaser shall pay (or cause to be paid) to Seller royalties equal to the amount calculated by multiplying (i) the applicable royalty rate set forth in the table below by (ii) the corresponding amount of incremental Annual Net Sales of a Product (including all indications and formulations of such Product) during each calendar year (“Royalties”), or such amounts as may otherwise be agreed by Purchaser and Seller pursuant to Section 3.3(j):

 

Portion of Annual Net Sales of a Product in a calendar year that falls within the
following tiers:

   Seller
Royalty Rate
 

[***]

     [***] % 

[***]

     [***] % 

[***]

     [***] % 

[***]

     [***] % 

(d) Royalty Term. Royalties shall be payable on a Product-by-Product and country-by-country basis from the First Commercial Sale of a Product in a country until the later of: (i) [***] from such First Commercial Sale of such Product in such country; (ii) expiration of all Regulatory Exclusivity for such Product in such country; and (iii) expiration of the last-to- expire Valid Claim of the Product Patents Covering the manufacture, use, sale, offer for sale or import of such Product in such country (the “Royalty Term” for such Product in such country).

 

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(e) Selected Definitions.

(i) “Annual Net Sales” means, with respect to a Product, total worldwide Net Sales of such Product during a calendar year.

(ii) “Combination Product” means a Product that includes at least one additional active ingredient other than the Compound. Drug delivery vehicles, adjuvants, and excipients shall not be deemed to be “active ingredients”, except in the case where such delivery vehicle, adjuvant, or excipient is recognized by the FDA as an active ingredient in accordance with 21 CFR 210.3(b)(7).

(iii) “First Commercial Sale” means, with respect to a Product in a country, the first sale for use or consumption by the general public of such Product in such country after Regulatory Approval of such Product has been granted, or such marketing and sale is otherwise permitted, by the Regulatory Authority of such country. First Commercial Sale will not include distribution or other sale solely for Clinical Trials or under patient assistance, named patient use, compassionate use, or other patient access programs, in each case, where the Product is supplied without charge or below or at the actual manufacturing cost thereof or any early access programs before reimbursement approvals are obtained in countries where reimbursement approval is required.

(iv) “Net Sales” means, [***].

(v) “Regulatory Exclusivity” means, with respect to a Product in a country or other jurisdiction, any additional market protection, other than Patent protection, granted by a Regulatory Authority for such Product in such country or other jurisdiction which (a) confers an exclusive Commercialization period during which Purchaser or its Affiliates or (sub)licensees can exclusively market and sell such Product in such country or other jurisdiction through such regulatory exclusivity right, including such rights conferred in the U.S. under the Biologics Price Competition and Innovation Act (BPCIA), the Hatch Waxman Act, pediatric exclusivity, orphan drug exclusivity, or rights similar thereto outside the U.S., or (b) limits or prohibits a Person from relying on the Regulatory Approval or the safety or efficacy data supporting the Regulatory Approval of a Product to support an Abbreviated Application referencing such product.

(f) Reduction for No Valid Claim, No Valid Claim or Regulatory Exclusivity, or Generic Competition.

(i) On a Product-by-Product and country-by-country basis, during any portion of the Royalty Term for a Product in a country when no Valid Claim of any Product Patent in such country Covers such Product or the manufacture, use, sale, offer for sale or import of such Product in such country, but there is Regulatory Exclusivity for such Product in such country, the Royalties payable to Seller under Section 3.3(c) with respect to such Product in such country shall not be subject to any reduction on account thereof, unless applicable Law in such country requires a royalty reduction under such circumstances, in which event the Royalties payable to Seller under Section 3.3(c) with respect to such Product in such country shall be reduced to [***]% of the amount otherwise payable for the remainder of the Royalty Term for such Product in such country.

 

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(ii) On a Product-by-Product and country-by-country basis, during any portion of the Royalty Term for a Product in a country when no Valid Claim of a Product Patent in such country Covers such Product or the manufacture, use, sale, offer for sale or import of such Product in such country, and there is no Regulatory Exclusivity for such Product in such country, the Royalties payable to Seller under Section 3.3(c) with respect to such Product in such country shall be reduced to [***]% of the amount otherwise payable under Section 3.3(c) for the remainder of the Royalty Term for such Product in such country.

(iii) On a Product-by-Product and country-by-country basis, if during a calendar quarter during the Royalty Term one or more Generic Versions of a Product are commercialized in a given country, and the aggregate number of units of such Generic Versions included in total prescriptions (including both new prescriptions and refills) during such calendar quarter in such country equals or exceeds [***]% of the aggregate units of the sum of all such Generic Versions and such Product units included in total prescriptions (including both new prescriptions and refills) in such calendar quarter in such country (as determined by data obtained from a mutually agreed Third Party source), the Royalties payable to Seller under Section 3.3(c) with respect to such Product in such country shall be reduced to [***]% of the amount otherwise payable under Section 3.3(c) for the remainder of the Royalty Term for such Product in such country. “Generic Versions” means with respect to a Product being sold in a particular country, a pharmaceutical product that: (A) is sold in such country by a Third Party that is not a Selling Party and that did not purchase such product in a chain of distribution that included any Selling Party; (B) contains the same Compound (and, if such Product is a Combination Product, the same other active ingredient) as such Product in the same dosage form, strength (for each active ingredient and route of administration) as such Product; and (C) has been approved for marketing or sale by the relevant Regulatory Authority in such country by means of an abbreviated procedure that relies in whole or in part, on the safety and efficacy data contained or referenced in the NDA for such Product submitted by or on behalf of Purchaser or other Selling Party in such country.

(iv) In the event that a Selling Party obtains through license, acquisition or other rights under Patents of Third Parties (excluding any Selling Party) that would, in the absence of such rights, be infringed by the manufacture, use, sale, offer for sale or import of the Compound contained in a Product sold in a country (“Third Party Licenses”), then Purchaser may credit against the Royalties payable to Seller under Section 3.3(c) with respect to such Product in such country for a calendar quarter up to [***]% of the royalties or similar payments based on Net Sales in lieu of royalties (e.g., revenue share or profit share) actually paid by a Selling Party under such Third Party Licenses with respect to sales of such Product in such country for such calendar quarter.

(v) In no event will the Royalties payable to Seller under Section 3.3(c) with respect to such Product in such country for any calendar quarter be reduced as a result of any and all the reductions set forth in this Section 3.3(f) in the aggregate by more than [***]% of the Royalties that would otherwise be payable to Seller in such country during such calendar quarter without application of any reductions set forth in this Section 3.3(f), but any portion of payments made under Third Party Licenses with respect to sales of a Product in a country that Purchaser would have been entitled to credit against Royalties payable to Seller pursuant to Section 3.3(f)(iv) in the absence of the foregoing limitation on aggregate reductions in any calendar quarter shall be carried over and applied against Royalties payable to Seller in respect of such Product in such country in subsequent calendar quarters, subject in each such calendar quarter to the foregoing limitation, until the full deduction is taken.

 

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(g) Payment; Reports. Royalties shall be calculated and reported for each calendar quarter, and shall be paid within [***] after the end of the calendar quarter. Each such payment shall be accompanied or preceded by a report of Net Sales in such calendar quarter in sufficient detail to permit confirmation of the accuracy of the payment made, including, on a Product-by-Product and country-by-country basis, the number of each type of Product sold, gross amounts invoiced, Net Sales, deductions (by major category) from gross amounts invoiced to arrive at Net Sales, any reductions made or credits taken pursuant to Section 3.3(c) or (f) to determine Royalties payable, and the exchange rates used. All such reports (and any additional information provided under Section 3.3) shall be deemed the Confidential Information of Purchaser.

(h) Exchange Rate; Manner and Place of Payment; Late Payments. All payment amounts specified in this Agreement are expressed in U.S. Dollars, and all payments due hereunder shall be payable in U.S. Dollars. When conversion of payments from any currency other than U.S. Dollars is required, such conversion shall be calculated using the exchange rate published by The Wall Street Journal, Eastern U.S. Edition, on the last day of the calendar quarter in which the applicable Net Sales are made. All payments owed under this Agreement shall be made by wire transfer in immediately available funds to a bank and account designated in writing by Seller, unless otherwise specified in writing by Seller. If Seller does not receive payment of any sum due to it hereunder on or before the due date therefor, simple interest shall thereafter accrue on the sum due from the due date, including from when a payment was determined to have been due pursuant to Section 11.1, until the date of payment at a per-annum rate of [***]% above the prime rate as reported in The Wall Street Journal, Eastern U.S. Edition on the date such payment is due (or the next closest Business Day), or the maximum rate allowable by applicable Law, whichever is less (the “Late Interest Rate”).

(i) Tax Treatment. All payments made pursuant to this Section 3.3 shall be treated as additional Consideration for U.S. federal income Tax purposes, except as required by applicable law.

(j) Change of Control of Seller [***]. In the event that Seller intends to enter into a Change of Control (as defined in the BMS License) [***] (as such terms are defined in the BMS License): (i) Seller shall promptly notify Purchaser of such intent in writing; (ii) the Parties shall discuss in good faith and mutually agree on an amendment to this Agreement that provides for appropriate reductions (or changes) to the amount (or timing) of the Closing Payment, Milestone Payments and/or Royalties that may become payable by Purchaser to Seller under this Agreement to make Purchaser whole for the increase in milestones, sublicensing revenue and royalties payable to BMS under the BMS License following a Change of Control (as defined in the BMS License) of Seller that occurs [***] (as such terms are defined in the BMS License) in comparison to what BMS would be owed under the BMS License if a Change of Control (as defined in the BMS License) of Seller did not occur [***] (as such terms are defined in the BMS License); and (iii) until the Parties have amended this Agreement pursuant to this Section 3.3(j), Seller shall not consummate any such Change of Control (as defined in the BMS License) [***] (as such terms are defined in the BMS License) without Purchaser’s prior written consent.

 

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3.4 Withholding. Purchaser and its agents (as applicable) shall be entitled to deduct and withhold from any amounts payable or otherwise deliverable pursuant to this Agreement such amounts as such Person is required to deduct or withhold therefrom under any applicable Laws and shall pay the amounts withheld to the appropriate Governmental Authority. To the extent such amounts are so deducted or withheld and properly remitted to the appropriate Governmental Authority, Purchaser will send evidence of the obligation together with proof of Tax payment to Seller on a reasonable and timely basis following such Tax payment. Any amounts properly deducted and withheld by Purchaser or its agent from payment to Seller shall be treated for all purposes under this Agreement as having been paid to Seller. Each Party agrees to use commercially reasonable efforts to cooperate with the other Party in claiming refunds, reductions, or exemptions from such deductions or withholdings under any relevant agreement or treaty that is in effect. Seller will provide Purchaser with any Tax forms or other documentation reasonably necessary in order for Purchaser not to withhold or to withhold Tax at a reduced rate under an applicable bilateral income Tax treaty. Notwithstanding the foregoing, if withholding is required under applicable Laws and such withholding payments result from a Withholding Action by Purchaser or its affiliates then Purchaser shall pay an additional amount to Seller such that, after withholding from the payments provided for in this Agreement and such additional amount, Seller receives the same after-withholding amount as it would have received from Purchaser absent such deduction or withholding and such additional amount.

3.5 Post-Closing Operations.

(a) Development and Commercialization. Contingent upon and commencing upon the Closing, as between the Parties, Purchaser shall be solely responsible, in its discretion (subject to Section 3.5(b)) and at its own expense, for (i) research and Development of Compounds and Products, (ii) preparing any and all Regulatory Filings and other Regulatory Documentation for any Product and for interacting with all Regulatory Authorities with respect thereto, (iii) all pharmacovigilance and other safety-related activities in connection with Compounds and Products, (iv) manufacture of Compounds and Products, and (v) Commercialization of Products.

(b) Purchaser Diligence. Commencing upon the Closing, Purchaser shall use Diligent Efforts, itself or through other Milestone Obligors, to achieve the Milestone Events set forth in Section 3.3(a) and achieve Regulatory Approval for at least one Product in at least one Indication in the U.S.

(c) Updates. For so long as any Milestone Payments may become payable, Purchaser shall provide, by [***] of each calendar year following the Closing Date, a written report to Seller in reasonable detail regarding the status of efforts to achieve the Milestone Events (each such report, an “Update Report”). Within [***] after delivery of an Update Report, Seller or a Representative thereof shall have the right to seek a teleconference with a Representative of Purchaser, having appropriate expertise, to respond to Seller’s reasonable questions concerning such Update Report. Seller may not request more than one such meeting for any Update Report. Notwithstanding anything herein to the contrary, such Update Report will not include any patient or clinical trial subject-specific health information or personally-identifiable data. All information contained in any Update Report, or conveyed to Seller in any meeting or other communication regarding an Update Report, shall be deemed Confidential Information of Purchaser.

 

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(d) Audit Right. Purchaser will keep, and will cause the Selling Parties to keep, books and accounts of record in connection with the sale of Products in sufficient detail to permit verification of Royalties to be paid hereunder. Purchaser and its Affiliates will maintain such records for a period of three years after the end of the calendar quarter in which they were generated. Such records shall be available during normal business hours at Purchaser’s premises upon [***] prior written notice by Seller for inspection at the expense of Seller by a certified public accountant selected by Seller and acceptable to Purchaser (such acceptance not to be unreasonably withheld or delayed). The inspector’s review shall not interfere unreasonably with Purchaser’s business activities, and such review shall be in compliance with the other terms of this Agreement for the sole purpose of verifying reports and payments of Royalties in accordance with the terms of this Agreement. The inspector may inspect records for up to [***] after the end of the period to which they pertain. Audits may not take place more than [***] per calendar year and no period may be audited more than [***]. Such inspector shall not disclose to Seller or any Third Party any information other than information relating to the accuracy of reports and payments of Royalties made under this Agreement. Details of the inspector’s findings (including, for the avoidance of doubt, monetary values and supporting calculations) shall not be shared with Purchaser except in the form of a summary report. In any event, the results shall be communicated to Purchaser before being shared with Seller. Purchaser shall be given a period of [***] to review and respond to the inspector’s findings before the summary report may be provided to Seller, such reports to include Purchaser’s response to the findings. The inspector shall not be permitted to include any extrapolation calculations in the calculation of amounts underpaid to Seller. In the event that any such inspection shows an under reporting and underpayment of Royalties in excess of [***]% for any calendar year, then Purchaser shall pay the reasonable costs of the audit as well as any additional Royalties that would have been payable to Seller had Purchaser reported correctly, plus an interest charge on the additional Royalties (but not on the costs of the audit) at the Late Interest Rate, within [***] of Seller notifying Purchaser that the audit has been completed and Purchaser’s receipt of a written invoice with respect thereto. Such interest shall be calculated from the date the correct payment was due to Seller up to the date when such payment is actually made by Purchaser. If an audit reveals an overpayment (the amount of each such overpayment, an “Overpayment Amount”), then, as may be requested by Purchaser, (x) the Overpayment Amount will be credited against any future amounts payable to Seller by Purchaser, or (y) Seller shall reimburse Purchaser for such Overpayment Amount (or any portion thereof that has not been credited as set out in the foregoing clause (x)) within [***] after the date such inspector reveals to Purchaser such Overpayment.

(e) Non-Transferable Right. The right of Seller to receive any amounts with respect to Milestone Payments or Royalties (i) shall not be evidenced by a certificate or other instrument, (ii) shall not be assignable or otherwise transferable by Seller other than pursuant to a court Order, by operation of Law (including a consolidation or merger), without consideration in connection with the dissolution, liquidation or termination of any corporation, limited liability company, partnership or other entity, and (iii) does not represent any right other than the right to receive the Milestone Payments or Royalties pursuant to this Agreement. Any attempted transfer of the right to any amounts with respect to any such payment by any holder thereof (other than as specifically permitted by the immediately preceding sentence) shall be null and void. Nothing in this Section 3.5(e) shall prohibit an assignment of this Agreement in accordance with Section 11.8.

 

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4. CLOSING

4.1 Closing. Subject to the satisfaction or waiver of the conditions set forth in Article 7 and Article 8, and unless this Agreement shall have been validly terminated in accordance with Article 10, the consummation of the Transactions, including the closing of the sale of the Acquired Assets and the assumption of the Assumed Liabilities pursuant to this Agreement (the “Closing”) shall take place remotely via the electronic exchange of documents and signatures, on a date (no later than the third business day after the satisfaction or waiver of the last of the conditions set forth in Article 7 and Article 8 to be satisfied, other than those conditions that by their nature are to be satisfied at Closing, but subject to the satisfaction or waiver of such conditions) to be agreed upon by Purchaser and Seller. For purposes of this Agreement, “Closing Date” shall mean the date on which the Closing actually takes place.

4.2 Deliveries at Closing.

(a) Deliveries of Seller. On or before the Closing, Seller shall deliver or caused to be delivered to Purchaser the following:

(i) a duly executed counterpart of the Assignment and Assumption Agreement;

(ii) a duly executed counterpart of the Bill of Sale;

(iii) a duly executed counterpart of the Escrow Agreement;

(iv) a duly executed counterpart of the Transition Services Agreement;

(v) a duly executed and valid IRS Form W-9 from Seller;

(vi) duly executed counterparts of all approvals, consents, and waivers that are listed on Section 5.1(c) of the Disclosure Schedules, except to the extent waived by Purchaser;

(vii) evidence, reasonably satisfactory to Purchaser, that all Liens (other than Permitted Liens) relating to any of the Acquired Assets have been removed;

(viii) any letter of transfer required to transfer any Regulatory Filings;

(ix) evidence reasonably satisfactory to Purchaser of having the ongoing right to access and use, at no additional cost, from and after Closing all cell lines of BMS or any Third Party used in the development, manufacturing or commercialization of any Product;

(x) at Purchaser’s reasonable request, such other instruments as are necessary to document and to transfer good and valid title to all intangible Acquired Assets from Seller to Purchaser; and

(xi) [***], unless the Parties have agreed that Purchaser will be responsible for preparation of [***], and, except in the case of a Requested Option Package Trigger, any other Deliverables (each as defined in the Collaboration Agreement) to the extent not previously delivered to Purchaser.

 

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(b) Deliveries by Purchaser. On or before Closing, Purchaser shall deliver or caused to be delivered to Seller the following:

(i) a duly executed counterpart of the Assignment and Assumption Agreement;

(ii) a duly executed counterpart of the Bill of Sale;

(iii) a duly executed counterpart of the Escrow Agreement by both Purchaser and the Escrow Agent; and

(iv) a duly executed counterpart of the Transition Services Agreement.

4.3 Possession. Seller shall (a) place Purchaser in actual possession and operating control of all Acquired Assets that are tangible assets and all Patent Documents at Closing; and (b) deliver possession of all other Acquired Assets to Purchaser at Closing or as soon as reasonably practicable following the Closing. Without limiting the generality of the foregoing, Seller, at no additional cost, shall work with Purchaser to transfer all Acquired Assets stored in electronic form, wherever stored, in an agreed upon format as soon as reasonably practicable following the Closing and shall provide to Purchaser, at no additional cost, access to all such Acquired Assets as requested by Purchaser, prior to the transfer of such electronic data to Purchaser. Further, Seller shall make its employees reasonably available and shall support the transfer of all technology included with the Acquired Assets to Purchaser. Title to Inventory shall be conveyed by delivery to Purchaser upon Closing.

5. REPRESENTATIONS AND WARRANTIES.

5.1 Representations and Warranties of Seller. For purposes of this Section 5.1, references to “Seller” shall refer to Seller and each Subsidiary of Seller and/or corporation, limited liability company, or other entity or Person that has been liquidated or merged into Seller, unless the context clearly indicates otherwise. Except as set forth in the disclosure schedules delivered by Seller on the Agreement Date (the “Initial Schedules”) or the Updated APA Schedules delivered in accordance with Section 4.3 of the Collaboration Agreement (the “Schedule Delivery Date”) (the “Updated Schedules” and, collectively with the Initial Schedules, the “Disclosure Schedules”), as applicable, Seller makes the following representations and warranties to Purchaser as of the Agreement Date and as of the Schedule Delivery Date (except, in each case, to the extent such representations and warranties speak expressly as of a different date, and then, as of such date) as follows; provided, however, that (i) for purposes of determining the accuracy of the representations and warranties of Seller as of the Agreement Date, the representations and warranties shall be deemed qualified only by such exceptions as are disclosed in the Initial Schedules and the references herein to the Disclosure Schedules shall be deemed to be references only to the Initial Schedules, and (ii) for purposes of determining the accuracy of the representations and warranties of Seller as of the Schedule Delivery Date, the representations and warranties shall be deemed qualified only by such exceptions as are disclosed in the Updated Schedules and the references herein to the Disclosure Schedules shall be deemed to be references only to the Updated Schedules:

 

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(a) Organization and Existence. Seller is a corporation duly organized, validly existing and in good standing under the laws of its jurisdiction of organization. Seller has the requisite corporate power and authority to own, use and operate the Acquired Assets as currently conducted. Seller is duly qualified or licensed to do business and in good standing as a foreign corporation in each jurisdiction in which the ownership of the Acquired Assets or the conduct of its business requires such qualification or license, except for those jurisdictions where the failure to be so qualified or licensed and in good standing has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. Seller has delivered to Purchaser accurate and complete copies of the Organizational Documents of Seller, and since the Look-Back Date there has not been any violation of any of the provisions of Seller’s Organizational Documents. Other than Q32 Australia and Q32 Bio Securities Corporation, as Massachusetts securities corporation, Seller has no, and has never had had any, Subsidiaries, nor does Seller control, directly or indirectly, any other Person. Q32 Bio Securities Corporation does not own, control or possess, and has never owned, controlled or possessed any of the Acquired Assets.

(b) Authority; Binding Nature of Agreements. Seller has all requisite power and authority to enter into this Agreement, the Collaboration Agreement, the Related Agreements, and the other agreements, instruments, and documents to be executed and delivered in connection herewith and therewith to which Seller is (or becomes) a party, and to consummate the Transactions. The execution and delivery of this Agreement and the Related Agreements to which Seller is a party, the grant of the Option and the consummation of the Transactions by Seller, including the sale of the Acquired Assets, have been duly authorized by all necessary corporate and stockholder action, if required, and no further corporate or stockholder action is required on the part of Seller to authorize this Agreement or any Related Agreements to which Seller is a party or the Transactions or for Seller to perform its obligations under this Agreement or any other Related Agreements. This Agreement and the Collaboration Agreement have been duly executed and delivered by Seller and the Related Agreements will be duly executed and delivered by Seller, and, assuming the due execution and delivery of this Agreement the Collaboration Agreement by Purchaser and of the Related Agreements by the counterparties thereto, this Agreement the Collaboration Agreement constitute, and the Related Agreements when so executed and delivered will each constitute, a valid and legally binding obligation of Seller, enforceable against it in accordance with their respective terms, except as enforceability may be affected by bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and other similar Laws relating to or affecting creditors’ rights generally, and general equitable principles (whether considered in a Proceeding in equity or at Law) (collectively, the “Enforceability Exception”).

(c) No Conflict. The execution and delivery of this Agreement, the Collaboration Agreement and the Related Agreements does not, and the consummation of the Transactions will not, conflict with or result in any violation of or default under (with or without notice or lapse of time, or both) or give rise to, any payment obligation, or a right of termination, cancellation, modification or acceleration of any obligation or loss of any benefit under (any such event, a “Conflict”) (i) any provision of Seller’s Organizational Documents, (ii) any Acquired Business Contract, or (iii) any material Law or material Order applicable to the Acquired Assets,

 

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or any Product or Compound. The execution and delivery of this Agreement and the Related Agreements does not, and the consummation of the Transactions will not result in the creation or imposition of any Lien other than Permitted Liens on the Acquired Assets. Section 5.1(c) of the Disclosure Schedules sets forth (i) all necessary notices, consents, waivers and approvals of parties to any Acquired Business Contracts that are required thereunder in connection with the Transactions, or for any such Acquired Business Contract to remain in full force and effect without limitation, modification, or alteration after the Closing so as to preserve all rights of, and benefits to, Purchaser under such Acquired Business Contracts from and after the Closing, other than any limitation, modification, or alteration by Purchaser and (ii) all necessary notices, consents, waivers and approvals of any Third Parties required in order to consummate the Transactions.

(d) Governmental Approvals and Filings. No consent, notice, waiver, approval, order, or authorization of, or registration, declaration, or filing with, any Governmental Authority or any Third Party, including a party to any Acquired Business Contract (so as not to trigger any Conflict), is required by, or with respect to, Seller in connection with the execution and delivery of this Agreement, the Collaboration Agreement, the Related Agreements, or the consummation of the Transactions, except for filings under applicable securities laws or rules of the applicable stock exchange and except for any approvals or clearances required under Antitrust Laws in order to close the sale of the Acquired Assets under this Agreement.

(e) Taxes.

(i) All material Tax Returns required to be filed by Seller or its Affiliates with respect to the Acquired Assets have been filed and such Tax Returns are true and correct in all material respects. All material Taxes due and owing by Seller (whether or not shown on a Tax Return) attributable to the Acquired Assets have been paid. Seller has withheld all material Taxes required to be withheld in respect of payments to any Third Party to the extent related to the Acquired Assets and remitted all such withheld Taxes to the appropriate Governmental Authority. No power of attorney that is currently in effect has been granted by Seller with respect to the Acquired Assets (other than powers of attorney granted in the ordinary course of business, such as to a payroll provider).

(ii) There are no Liens for unpaid Taxes on the Acquired Assets (other than Permitted Liens). There is no Tax Contest pending or, to the Knowledge of Seller, threatened, that relates to the Acquired Assets.

(iii) Seller is not a foreign person as that term is defined in Treasury Regulations Section 1.1445-2.

(iv) The Acquired Assets do not include any tax-sharing agreements, United States real property assets, or stock or other ownership interests in any corporations, partnerships, joint ventures, limited liability companies, business trusts, or other entities (other than discarded entities).

 

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(v) No jurisdiction in which Seller does not file Tax returns in respect of the Acquired Assets, or the Product Operations, has ever asserted in writing that Seller may be required to file a Tax return in such jurisdiction with respect to the Acquired Assets or the Product Operations relating to the Acquired Assets. No Taxes have attached to the Acquired Assets and will become a liability of Purchaser as a result of the execution of this Agreement and purchase of the Acquired Assets.

(vi) Seller has not waived any statute of limitations in respect of Taxes attributable to the Product Operations or the Acquired Assets, which waiver is currently in effect.

(f) Title. None of the Acquired Assets is subject to any Liens (including Tax- related Liens). Seller has good title to all of the Acquired Assets (whether real or personal, tangible or intangible). At the Closing, Seller will transfer to Purchaser good and marketable title to all Acquired Assets, free and clear of any Liens other than Permitted Liens. No Affiliate of Seller has title to any of the Acquired Assets.

(g) Compliance with Laws.

(i) Seller is in compliance with, and during the past three years has complied in all material respects with, all Laws and Orders applicable to the Acquired Assets and the conduct of the Product Operations;

(ii) Seller, and to the Knowledge of Seller and its Affiliates and each Person acting on its behalf, is and during the past three years has been, in compliance, in all material respects, with (A) all applicable Laws relating to the privacy, data protection and security of any personal information, (B) all privacy, data protection and security policies of Seller concerning patient medical records and other personal information, and (C) any contractual requirements to which Seller and its Affiliates are subject that relate to any of the foregoing. The execution, delivery and performance of this Agreement and the consummation of the Transactions will comply, in all material respects, with all applicable (x) Laws, (y) policies of Seller concerning patient medical records and other personal information, and (z) contractual requirements to which Seller or its Affiliates are subject, in each case (x) through (z) relating to privacy, data protection and security of personal information; and

(iii) Since the Look-Back Date, Seller has received no written notification or communication from any Governmental Authority (A) asserting that Seller is not in compliance with any Law or Order with respect to the Acquired Assets or (B) threatening to revoke or suspend any Transferred Permit owned or held by Seller relating to the Acquired Assets or the Development, manufacturing of Commercialization of any Products or Compounds.

(h) Permits. Section 5.1(h) of the Disclosure Schedules contains a complete list of all Permits that constitute Acquired Assets (the “Transferred Permits”). Seller possesses all such Transferred Permits, and each such Transferred Permit is validly and presently in effect (and the continuing validity and effectiveness of such Transferred Permit will not be affected by the consummation of the Closing), and Seller is not in default (with or without notice or lapse of time, or both) under any Transferred Permit in any material respect. There are no Actions pending, nor to the Knowledge of Seller, threatened in writing, that seek the revocation, cancellation, suspension, failure to renew or materially adverse modification of any such Transferred Permit. Since the Look-Back Date, all required filings with respect to each such Transferred Permit have been timely made and all required applications for renewal thereof have been timely filed.

 

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(i) Material Contracts.

(i) Section 5.1(i)(i) of the Disclosure Schedules sets forth a true and accurate list of each Contract (other than purchase orders issued by Seller to a Third Party that are ancillary to another written Contract with the same Third Party and that do not constitute an Assumed Liability) in effect as of the date of this Agreement and as of the Schedule Delivery Date to which Seller is a party or by which any of the Acquired Assets is bound in the following categories (the “Material Contracts”):

(A) any Contract establishing a joint venture or collaboration, co-promotion or like arrangement, or involving a sharing with another Person of profits, losses, costs, royalties, milestone payments, or Liabilities of Seller relating to the Acquired Assets or the Development, manufacture, or Commercialization of any Compound or Product, including the conduct of any clinical trials;

(B) any Contract containing covenants prohibiting or limiting the right to compete or engage in any aspect of the Product Operations or prohibiting or restricting Seller’s ability to conduct the Product Operations with any Person or in any geographical area;

(C) any Contract granting most favored nation or exclusive rights relating to any Compound or Product to any other Person;

(D) any Contract pursuant to which Seller has obtained or granted any Intellectual Property included in the Acquired Assets (or that would have been included in the Acquired Assets but for such Contract), including any covenant not to enforce or assert, including any existing license agreement relating to any Compound or Product or the Product Operations and each other Contract under which Seller is a licensor or licensee of any Intellectual Property relating to any Compound or Product or the Product Operations other than any of the following entered into in the Ordinary Course of Business and, in each case, that are not Acquired Business Contracts and are deemed Excluded Liabilities: (i) Nondisclosure Agreements, (ii) services agreements containing non-exclusive licenses to Intellectual Property included in the Acquired Assets for the sole purpose of a service provider performing services for or on behalf of Seller, (iii) agreements with clinical investigators and clinical sites for the conduct of a clinical study, which study is complete or substantially complete at the relevant clinical sites as of the date of this Agreement, (iv) licenses to commercially available software or cloud or software as a service agreements, and (v) assignment agreements with employees, including proprietary information and invention assignment agreements with employees;

(E) any Contract under which Seller pays or receives royalty payments relating to any Compound or Product or any Product IP;

(F) any Contract relating to the creation of Liens on any Acquired Assets or the guarantee of the payment of Liabilities or performance of obligations of any other Person by Seller relating to any Compound or Product or any Acquired Assets;

(G) any Contract entered into by Seller or any of its Affiliates in settlement of any Proceeding or other dispute relating to the Acquired Assets or the Product Operations, including the conduct of any Clinical Trials;

 

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(H) any Contract that limits Seller’s ability to make generally available any versions of any Compound or Product developed by or for Seller;

(I) any Contract for the research or Development of any Compound or Product, other than any of the following entered into in the Ordinary Course of Business and, in each case that are not Acquired Business Contracts and are deemed Excluded Liabilities: (i) standalone indemnity arrangements with clinical trial sites or clinical trial investigators, (ii) powers of attorney, letters of delegation, declarations and similar instruments executed by Seller in connection with the regulatory and ethics committee submissions and data processing activities for clinical studies outside of the U.S. (other than local representative agreements and legal representative agreements or similar arrangements for local representation entered into with a contract research organization or similar service provider), (iii) Nondisclosure Agreements, (iv) licenses to commercially available software or cloud or software as a service agreements, and (v) service agreements with quality assurance auditors, meeting planners, Third Parties providing meeting support services, and non-physician advisory board participants (i.e. nurse advisors);

(J) any Contract for the ongoing or planned development, manufacture, supply, packaging, labeling, distribution, analytical testing, or storage of the active pharmaceutical ingredients and other raw materials for any Compound or Product, and related quality agreements, including all Contracts relating to cell lines for any Compound or Product;

(K) any Contract for the ongoing or planned analytical testing or storage of biological specimens collected from subjects participating in clinical trials of any Compound or Product;

(L) any Contract for the Commercialization of any Compound or Product;

(M) any Contract for the maintenance of the safety database for any Compound or Product, and any safety data exchange agreements or pharmacovigilance agreements directly related to any Compound or Product; and

(N) any Contract with any Governmental Authority directly relating to any Compound or Product or any of the Acquired Assets, other than clinical trial agreements and related ancillary agreements with public institutions; and

(O) any other Contract that is material to the Development, manufacture or sale of any Compound or Product, in each case, as currently conducted by Seller, other than any Contract relating to (i) real property, (ii) employees, or employee compensation or benefit matters, including any Employee Benefit Plan, (iii) indebtedness, other than indebtedness associated with any Lien on any Acquired Asset, (iv) general administration expenses, or (v) insurance.

(ii) All of the Material Contracts are valid and binding agreements of Seller, enforceable in accordance with their terms, subject to the Enforceability Exception. With the exception of financial terms that have been redacted from certain Material Contracts that are not Acquired Business Contracts, Seller has made available or delivered to Purchaser a correct and

 

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complete copy of each written Material Contract. Seller is not in material breach or material default of any of the Material Contracts or, to the Knowledge of Seller, the Nondisclosure Agreements, and no event has occurred that with notice or lapse of time, or both, would constitute a material default by Seller under any Material Contract or, to the Knowledge of Seller, the Nondisclosure Agreement. To the Knowledge of Seller, no other party to a Material Contract is in material breach or material default of such Material Contract and no event has occurred that with notice or lapse of time, or both, would constitute a material default by such other party under any Material Contract. No party has repudiated in writing or, to the Knowledge of Seller, otherwise provided notice of its intention to repudiate any provision of a Material Contract. To the Knowledge of Seller, none of the Material Contracts or Nondisclosure Agreements are subject to any Claims, charges, set offs, or defenses. Seller has not given to or received from any other Person any written or, to the Knowledge of Seller, other notice regarding any material violation or breach of, or default under, any Material Contract or Nondisclosure Agreement.

(j) Tangible Personal Property. Section 5.1(j) of the Disclosure Schedules lists all of the Inventory. The Inventory listed on Section 5.1(j) of the Disclosure Schedules has been maintained in accordance with Seller’s manufacturing practices and with GMP and is in usable condition for the Development of any Product or Compound, subject to its shelf life.

(k) Legal Proceedings.

(i) There are no Actions pending against or, to the Knowledge of Seller, threatened, related to the Product Operations, any Compound or Product, or any of the Acquired Assets, and there is no investigation, non-routine audit or other Proceeding pending or, to the Knowledge of Seller, threatened, related to the Product Operations, any Compound or Product, or any of the Acquired Assets, in each case, related to any Compound or Product or any of the Acquired Assets, by or before any Governmental Authority.

(ii) There is no Order to which Seller is subject or that is pending or, to the Knowledge of Seller, threatened that relates to the Acquired Assets or the Assumed Liabilities.

(l) Regulatory Compliance.

(i) Since the Look-Back Date, Seller has not been in violation of, and is not the subject of any Action with respect to the violation of, any Law or Order, and has not received any FDA Form 483, “warning letters”, or “untitled letters”, or other similar Governmental Authority notice of inspectional observations or deficiencies relating to the Product Operations. Since the Look-Back Date, no Compound or Product has been subject to any import detention or refusal by the FDA or other similar Regulatory Authority or any safety alert issued by the FDA or other similar Regulatory Authority. No Action is pending or, to the Knowledge of Seller, threatened with respect to any violation of any Law or Order by Seller, and Seller is and, since the Look-Back Date, has been in compliance in all material respects with all Laws and Orders, in each case related to the Product Operations. Since the Look-Back Date, Seller has not received any notice of any such Action or any Liability on the part of Seller to undertake or to bear all or any portion of the cost of any Product Operations remedial action of any nature. Since the Look-Back Date, Seller has not conducted any internal investigation with respect to any actual, potential or alleged material violation of any Law or Order by any director, officer or employee of Seller in

 

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connection with the Product Operations. Seller has filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Law or Permit for the Product Operations and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission).

(ii) Except to the extent not required to be conducted in accordance with GMP, all manufacturing operations and the manufacture of any Products and Compounds by or on behalf of Seller are being conducted and since the Look-Back Date, have been conducted in material compliance with applicable Laws and Orders and in accordance with GMP. The processes used to produce the Compounds and Products are adequate to ensure that the Compounds and Products will conform to the specifications established therefor. Seller has not received any complaints about the Compounds or Products. Since the Look-Back Date, Seller has not conducted any recalls of Products or Compounds.

(iii) Since the Look-Back Date, all preclinical testing and clinical trials in respect of the Product Operations conducted by or on behalf of Seller have been conducted in accordance with reasonable experimental protocols, procedures, and controls, as well as pursuant to applicable Laws and Orders and GCP and GLP, as applicable. Since the Look-Back Date, no clinical trial of any Product or Compound has been placed on clinical hold by the FDA or any similar Regulatory Authority. Seller has provided Purchaser with true and correct copies of available final study reports of all preclinical studies and clinical trials of any Products or Compounds that were completed prior to the date of this Agreement.

(iv) All human clinical trials conducted by or on behalf of Seller that are intended to be submitted to Governmental Authorities to support Regulatory Approval of the Compounds and Products have been and are being conducted in compliance in all material respects with applicable GCP, and all applicable Laws relating to protection of human subjects, including those contained in 21 CFR Parts 50, 54, 56 and 312, as amended, and any comparable state and foreign Laws.

(v) Since the Look-Back Date, Seller has complied with all adverse event reporting requirements applicable to the Products and Compounds. A list of all serious adverse events and suspected adverse reactions that occurred during any clinical trial in respect of the Product Operations, as well as any serious and unexpected suspected adverse reactions that were the subject of an IND safety report have been made available to Seller.

(vi) Seller is not the subject of any pending or, to the Knowledge of Seller, written threat of investigation by any Governmental Authority in respect of Seller or the Product Operations, including by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto or any other Governmental Authority that has jurisdiction over the operations of Seller under any similar policy. Neither Seller nor, to the Knowledge of Seller, any of its officers, employees, or agents acting for Seller, has committed any act, made any statement or failed to make any statement, relating to the Product Operations that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue

 

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Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. Since the Look-Back Date, neither Seller nor any current or former officer, employee or, to the Knowledge of Seller, agent of Seller with respect to the Product Operations has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in exclusion under 42 U.S.C. Section 1320a-7 or any similar state law or regulation or been debarred by the FDA under Article 306 of the FDC Act, 21 U.S.C. §335a, or any similar foreign or local law, rule, or regulation.

(vii) The Compounds and Products are being and have been researched, Developed, manufactured, labeled, stored, and tested in compliance in all material respects with all applicable requirements under the FDC Act, the Public Health Service Act, and their applicable implementing regulations, and all comparable state and foreign Laws in those jurisdictions outside the United States in which either (A) human clinical trials involving the Compounds and Products have been or are being conducted by Seller or (B) the Compounds and Products have been or are being manufactured by or for Seller.

(viii) Neither Seller nor any representative of Seller nor, to the Knowledge of Seller, any of its licensors, licensees or assignees of Product IP has received any notice that the FDA or any other Regulatory Authority has initiated, or threatened to initiate, any action to suspend any clinical trial sponsored by Seller with respect to the Compounds and Products, or to recall or suspend the manufacture of the Compounds and Products.

(ix) Seller has made available to Purchaser copies of any and all written notices of inspectional observations, establishment inspection reports, and any other documents, in each case, received by Seller prior to the Agreement Date from the FDA or comparable foreign Regulatory Authorities that identify lack of compliance with Laws of the FDA or comparable foreign Regulatory Authorities with respect to the Product Operations.

(x) There are no Proceedings pending or, to the Knowledge of Seller, threatened, relating to the Product Operations with respect to a material violation by Seller of the FDC Act or regulations promulgated thereunder or any other Law promulgated by any other Governmental Authorities.

(m) Intellectual Property.

(i) Section 5.1(m)(i) of the Disclosure Schedules identifies (A) all registered Product IP, (B) all applications for the registration of Product IP, and (C) all licenses, sublicenses, and other Contracts (excluding any agreement with an employee, consultant or contractor of Seller or its Affiliate in the Ordinary Course of Business that provides for the general assignment of inventions made in the course of employment by or providing services to Seller or its Affiliate, and non-exclusive licenses to commercially available or “off-the-shelf” software, or cloud or software as a service agreements, including so-called “shrink-wrap” or “click-wrap” licenses, which do not individually involve payments by Seller in excess of $[***]) (whether royalty bearing or non-royalty bearing) under which Seller is granted rights by others in any Product IP.

 

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(ii) Section 5.1(m)(ii) of the Disclosure Schedules identifies all License Grants in the Product IP, other than non-exclusive License Grants included in services agreements entered into in the Ordinary Course of Business for the sole purpose of a service provider performing services for or on behalf of Seller or its Affiliate, and non-exclusive licenses to commercially available or “off-the-shelf” software, or cloud or software as a service agreements, including so-called “shrink-wrap” or “click-wrap” licenses, which do not individually involve payments by Seller in excess of $[***] (“Non-Scheduled License Grants”) and Nondisclosure Agreements entered into in the Ordinary Course of Business.

(iii) Except for the rights identified in Section 5.1(m)(i) of the Disclosure Schedules and subject to the License Grants identified in Section 5.1(m)(ii) of the Disclosure Schedules, Seller owns and possesses all right, title, and interest in and to, free and clear of all Liens (other than Permitted Liens), all of Seller IP. There is no Intellectual Property owned or licensed (including by sublicense, covenant-not-to-assert, or any similar right or authorization) or purported to be owned or so licensed by Seller or its Affiliates that is necessary to the Product Operations other than the Product IP. All previously due fees associated with maintaining any Seller IP or other Product IP for which Seller is responsible for filing, prosecution or maintenance have been paid in full in a timely manner to the proper Governmental Authority, except where Seller has decided to (A) extend the deadline for payment, or (B) to the extent described in Section 5.1(m)(iii) of the Disclosure Schedules, abandon or cancel such Product IP (including any Intellectual Property that would have been Product IP but for such abandonment or cancelation). Upon the Agreement Date and the Closing, all of the Product IP shall be available for use by Purchaser on terms and conditions identical to those under which Seller owned or used the Product IP immediately prior to the Agreement Date or Closing, as applicable. No Product IP is subject to any outstanding consent or Order restricting the use thereof.

(iv) There is no Claim by any Third Party pending or, to Seller’s Knowledge, threatened against Seller contesting the validity, enforceability, or ownership of any Product IP. The validity or enforceability of registered Product IP or rights of Seller to use Product IP has not been challenged in any jurisdiction. Each item of registered Product IP is subsisting, enforceable and in full force and effect, and each item of registered Product IP that is not a Patent is valid, and in the case of registered Product IP that is a Patent, to Seller’s Knowledge, valid; no item of registered Product IP has been cancelled, expired, or abandoned. No Claim is pending or, to Seller’s Knowledge, threatened challenging Seller’s right to any Product IP or right to use any Product IP. No Claim is pending or, to Seller’s Knowledge, threatened to the effect that any registered Product IP is, or upon consummation of the Transactions will be, invalid or unenforceable.

(v) Seller has not misappropriated, and to Seller’s Knowledge, Seller has not infringed, diluted, violated, or otherwise conflicted, in each case, with any Intellectual Property of any Third Party in conducting the Product Operations. The Product Operations, including the use of the Compounds and Products, the manufacture, use, sale, and importation of the Compounds and Products, the possession, use, disclosure, copying, or distribution of any information, data, or other tangible or intangible assets in the possession of Seller regarding any Compound or Product included in the Acquired Assets, and the possession or use by Seller of the Product IP (A) has not and does not misappropriate(d), and to Seller’s Knowledge, has not and does not infringe(d), dilute(d), violate(d), or otherwise conflict(ed) with, in each case, any

 

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Intellectual Property of any other Person, and (B) to Seller’s Knowledge, if possessed and used in the same manner as Seller has in conducting the Product Operations, will not infringe, misappropriate, dilute, violate, or otherwise conflict with any Patents of any other Person. Seller has not received any written notice of any Claim (including by an offer to license any Intellectual Property) and there is no pending or, to Seller’s Knowledge, threatened Claim, or any basis for any Claim (whether or not pending or threatened), against Seller asserting that the Product Operations, or the manufacture, use, sale, and importation of any Compound or Product, may infringe, misappropriate, dilute, violate, or otherwise conflict with the Intellectual Property of any Person.

(vi) To Seller’s Knowledge, none of the Product IP is being infringed or is otherwise used or available for use by any Third Party other than by the License Grants as set forth on Section 5.1(m)(ii) of the Disclosure Schedules, the Non-Scheduled License Grants or confidentiality agreements entered into in the Ordinary Course of Business. Seller has not given any notice to any Person asserting infringement, misappropriation, dilution, or violation by any such Person of any of the Product IP. There are no pending, or, to Seller’s Knowledge, threatened or potential, claims of infringement, misappropriation, dilution, conflict, or violation of the Product IP by any Person.

(vii) Seller has obtained from all individuals who participated in any respect in the invention or authorship of any Seller IP effective written assignments of all ownership rights of such individuals in such Seller IP; and no Person who as of the Agreement Date claims to be an inventor of an invention claimed in any registered Seller IP is not identified as an inventor of such invention in the filed patent documents for such registered Seller IP.

(viii) Seller and its Affiliates have taken all reasonable measures to protect the secrecy, confidentiality, and value of all Product Know-How that constitutes trade secrets under applicable Laws (including requiring all employees, consultants, and independent contractors to execute agreements requiring all such employees, consultants, and independent contractors to maintain the confidentiality of such Product Know-How) and to Seller’s Knowledge, such Product Know-How has not been used by, or disclosed to, any Third Party except pursuant to such confidentiality agreements and there has not been a breach by any party to such confidentiality agreements.

(ix) Neither Seller nor any of its Affiliates has entered into a government funding relationship that would result in any payment obligations to any Governmental Authority or any rights to any Product or Acquired Asset residing in any Governmental Authority and neither the Product nor the Product Operations are subject to overriding obligations to the United States federal government as set forth in Public Law 96 517 (35 U.S.C. § 200 -204), as amended, or any similar obligations under the applicable Laws of any state or other country.

(x) The Product Patents constitute all Patents Controlled by Seller Covering any Compounds or Products.

 

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(xi) Seller and its Affiliates have the exclusive right to use all data generated in the course of, or as a result of, any clinical trial or other testing in humans conducted by or on behalf of Seller in respect of any of the Compounds or Products, except for (A) non-exclusive research licenses granted in the ordinary course of business to a Third Party university or institution that generated such data for non-commercial, medical and academic purposes, or to Third Party service providers or vendors solely to enable the performance of services on Seller’s behalf, or (B) data that constitutes or is included in the medical records of any individual.

(xii) Except for the Acquired Business Contracts set forth on Section 5.1(m)(xii) of the Disclosure Schedules, Seller is not bound by any Contract to indemnify, defend, hold harmless, or reimburse any other Person with respect to, or otherwise assumed or agreed to discharge or otherwise take responsibility for, any existing or potential intellectual property infringement, misappropriation, or similar claim.

(n) No Brokers. No broker, finder, or investment banker is entitled to any brokerage commission, finder’s fee or similar payment in connection with the Transactions based upon arrangements made by or on behalf of Seller.

(o) Affiliate Transactions. Neither Seller nor any of its Affiliates, nor, to the Knowledge of Seller, any current director or officer of Seller, (i) has any direct or indirect financial interest (excluding in their capacity as an employee or stockholder of Seller) (A) in, or is a director or officer of, any Person that is a material client, customer, supplier, lessor, lessee, debtor, creditor or competitor of Seller in respect of the Acquired Business Contracts or (B) in any material property, asset, or right that is owned or used by or on behalf of Seller exclusively in the conduct of the Product Operations or (ii) is, or during the last two calendar years has been, a party to any Acquired Business Contract.

(p) Certain Product Operations Activities. Since the Look-Back Date, neither Seller nor any of its officers, directors, and to the Knowledge of Seller, its employees, agents or representatives, or any Affiliate of or any Person associated with or acting for or on behalf of Seller, has directly or indirectly, acting for or on behalf of Seller, in each case, in connection with the Product Operations:

(i) used any funds for unlawful contributions, gifts, or entertainment or other unlawful payments, including having made or attempted to make any improper contribution or gift, bribe, rebate, payoff, influence payment, kickback, or other improper payment to any Person, private or public, regardless of what form, whether in money, property, or services to (A) obtain favorable treatment for business or Contracts secured, (B) pay for favorable treatment for business or Contracts secured, or (C) obtain special concessions or for special concessions already obtained, in each of clauses (A), (B), and (C) in violation of any requirement of applicable Law;

(ii) made or attempted to make any such contribution or gift, bribe, rebate, payoff, influence payment, kickback, or other improper payment in violation of any applicable written policy of Seller;

(iii) established or maintained any fund or asset for the purpose of making any such contribution or gift, bribe, rebate, payoff, influence payment, kickback, or other improper payment in violation of any applicable Law or applicable written policy of Seller. To the extent required by applicable Law, Seller has established and maintains a compliance program and reasonable internal controls and procedures that, for all periods prior to the Closing, were appropriate to satisfy the requirements of applicable Anti-Corruption Laws; or

 

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(iv) consummated any transaction, made any payment, entered into any contract or arrangement or taken any other action in violation of Section 1128B(b) of the U.S. Social Security Act, as amended.

(q) No Government Officials. To the Knowledge of Seller, no officer or director of Seller is a foreign or domestic government official or employee or a candidate for any foreign or domestic political office.

(r) Books and Records. Since the Look-Back Date, Seller has made and kept its books and records, including the Regulatory Documentation, in reasonable detail, and such books and records accurately and fairly reflect the activities of the Product Operations in all material respects.

(s) Solvency. Seller is solvent and currently: (i) is able to pay its debts as they become due; (ii) owns property that has a fair saleable value greater than the amounts required to pay its debts (including a reasonable estimate of the amount of all contingent liabilities); and (iii) has adequate capital to carry on its business. No transfer of property is being made and no obligation is being incurred in connection with the Transactions with the intent to hinder, delay or defraud either present or future creditors of Seller.

(t) Sufficiency of Acquired Assets. Except for the Material Contracts (other than the Acquired Business Contracts), the Acquired Assets are sufficient for the continued conduct of the Product Operations by Purchaser after the Agreement Date and Closing Date in substantially the same manner as currently conducted by Seller and constitute all of the material rights, property, and assets necessary to conduct the Product Operations as currently conducted by Seller except for services and the underlying assets used in connection with such services that are not specific exclusively to the Product Operations, including legal, compliance, pharmacovigilance, quality, regulatory, finance, accounting, corporate information and telecommunications technology services, equipment and software or software as a service, records management, human resources, personnel, insurance, safety/health/environment, payroll, employee benefit services, facilities, and real estate.

(u) Acquired Business Contracts. Immediately following the Closing, Purchaser will be permitted to exercise all of its rights under the Acquired Business Contracts without the payment of any additional amounts or consideration (unless otherwise agreed to by Purchaser) other than ongoing fees, royalties, or payments that Seller would otherwise have been required to pay pursuant to the terms of such Acquired Business Contracts had the Transactions not occurred.

(v) No Transfer of Employees. The Acquired Assets do not constitute all or substantially all of the assets of Seller, and Seller will continue to conduct other research and development unrelated to the Acquired Assets following the Closing. Unless Purchaser otherwise requests or agrees in writing, no employees of Seller will be transferred to Purchaser in connection with the Transactions.

 

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(w) Absence of Changes. Since the Look-Back Date, (i) there has not been any condition, change, effect, event occurrence, state of facts or development that, individually or in the aggregate, has resulted in or would be reasonably expected to result in a Material Adverse Effect and, (ii) there has not been any material loss, damage or destruction to, or any material interruption in the use of any Acquired Assets.

(x) Financial Statements. Seller will deliver to Purchaser (i) the most recently audited balance sheets of Seller and the related audited statements of operations and retained earnings and cash flows for such period, together with the notes thereto and (ii) the unaudited balance sheet of Seller as of close of Seller’s most recent fiscal quarter preceding the Schedule Delivery Date and the related unaudited statements of operations and retained earnings and cash flows for the number of months in the fiscal year ended as of the balance sheet date (the “Financial Statements”). Except as set forth on Section 5.1(x) of Disclosure Schedules and subject to the absence of footnotes and year-end audit adjustments with respect to any unaudited Financial Statement, the Financial Statements are accurate and complete in all material respects, have been prepared in accordance with GAAP on a consistent basis throughout the periods covered and present fairly the financial position of Seller as of the respective dates thereof and the results of operations and cash flows of Seller for the periods covered thereby.

5.2 Representations and Warranties of Purchaser. Purchaser hereby represents and warrants to Seller that:

(a) Organization and Existence. Purchaser is a corporation, duly organized, validly existing and in good standing under the laws of the state of its jurisdiction, with full power and authority to own, lease, and operate its business and properties and to carry on its business as and where such properties and assets are now owned or leased and such business is now conducted.

(b) Authority and Approval. Purchaser has the power to enter into this Agreement and each of the Related Agreements to which it is to be a party and to perform its obligations thereunder. The execution, delivery, and performance by Purchaser of this Agreement and the Related Agreements to which it is to be a party, and the consummation by Purchaser of the Transactions, have been duly authorized by all required action on the part of Purchaser. This Agreement has been duly executed and delivered by Purchaser and, when executed and delivered by Purchaser, the Related Agreements to which Purchaser is to be a party will have been duly executed and delivered by Purchaser. This Agreement is, and each of the Related Agreements to which Purchaser is to be a party when executed and delivered by Purchaser will be, the valid and binding obligations of Purchaser, enforceable against Purchaser in accordance with their respective terms, except as enforceability may be affected by the Enforceability Exception.

(c) No Conflict. The execution and delivery by Purchaser of this Agreement and each of the Related Agreements to which it is to be a party, and Purchaser’s compliance with the terms and conditions hereof and thereof, and the consummation by Purchaser of the Transactions, do not and will not (i) conflict with any of, or require any consent of any Person that has not been obtained under, Purchaser’s Organizational Documents, (ii) violate any provision of, or require any consent, authorization, or approval under, any Law or any Order applicable to Purchaser, (iii) conflict with, result in a breach of, constitute a default under (whether with or without notice or the lapse of time or both), accelerate or permit the acceleration of the

 

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performance required by, or require any consent, authorization, or approval under, any material Contract to which Purchaser is a party or by which it is bound or to which any of its assets or property is subject, or (iv) result in the creation of any Lien upon the assets or property of Purchaser, except in each case as would not reasonably be expected to have a material adverse effect on Purchaser or materially adversely affect the validity or enforceability of this Agreement against Purchaser or materially adversely affect the ability of Purchaser to consummate the Transactions.

(d) Governmental Approvals and Filing. No consent, authorization, approval, or action of, filing with, notice to, or exemption from any Governmental Authority on the part of Purchaser is required in connection with the execution, delivery and performance of this Agreement or any Related Agreements to which Purchaser is to be a party or the consummation of the Transactions, except for any approvals or clearances under Antitrust Laws required in connection with the acquisition of the Acquired Assets and except for any other consent, approval or action where the failure to obtain any such consent, approval, or action, to make any such filing, to give any such notice or obtain any such exemption would not be reasonably expected to (A) have a material adverse effect on Purchaser or (B) materially adversely affect the validity or enforceability against Purchaser of this Agreement or such Related Agreements or materially adversely affect the ability of Purchaser to consummate the Transactions.

(e) No Brokers. No broker, finder, or investment banker is entitled to any brokerage commission, finder’s fee, or similar payment in connection with the Transactions based upon arrangements made by or on behalf of Purchaser.

(f) Legal Proceedings. As of the Agreement Date, there are no Actions pending, or to the knowledge of Purchaser, threatened, against Purchaser that would reasonably be expected to prevent or delay the ability of Purchaser to enter into and perform its obligations under this Agreement, the Related Agreements, or the Transactions. There is no Order to which Purchaser is subject or that is pending or, to the knowledge of Purchaser, threatened that would reasonably be expected to prevent or delay the ability of Purchaser to enter into and perform its obligations under this Agreement, the Related Agreements or the Transactions.

(g) Availability of Funds; Solvency. If the Option is exercised, Purchaser will have available sufficient cash to enable it to pay the Consideration as required pursuant to Section 3.2. Purchaser is solvent and currently: (i) is able to pay its debts as they become due; (ii) owns property that has a fair saleable value greater than the amounts required to pay its debts (including a reasonable estimate of the amount of all contingent liabilities); and (iii) has adequate capital to carry on its business. No transfer of property is being made and no obligation is being incurred in connection with the Transactions with the intent to hinder, delay or defraud either present or future creditors of Purchaser.

 

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6. ADDITIONAL AGREEMENTS.

6.1 Public Disclosures. Seller shall only issue press releases related to the activities contemplated by this Agreement that have either (A) been approved by Purchaser or (B) are required to be issued by Seller under applicable Laws based upon advice of counsel. Seller shall provide Purchaser with a draft press release reasonably prior to its intended publication for Purchaser’s review. If Purchaser asks for modification, then Seller shall either make such modification or work with Purchaser to arrive at a press release that Purchaser approves. Notwithstanding the foregoing, each Party may make any public statement in response to questions by the press, analysts, investors or those attending industry conferences or financial analyst calls, or issue press releases, so long as any such public statement or press release is consistent with prior public disclosures or public statements approved pursuant to this Section 6.1 and which do not reveal nonpublic information about the other Party. If the filing of this Agreement with the U.S. Securities and Exchange Commission or any stock exchange on which securities issued by a Party or its Affiliate are traded is required by applicable Laws, the Parties shall coordinate in advance with each other in connection with such filing and each Party will use reasonable efforts to seek confidential treatment for the terms proposed to be redacted; provided that each Party will ultimately retain control over what information to disclose to any Governmental Authority or any stock exchange as the case may be.

6.2 Confidentiality. Seller agrees that for [***] following the Closing Date it shall hold in strict confidence, unless compelled to disclose by judicial or administrative process or by other Laws (and then only following reasonable prior written notice to Purchaser, to the extent practicable or legally permissible, so that Purchaser shall have an opportunity to object), all confidential information of Purchaser or the Acquired Assets to which it had access prior to the Closing and will not release or disclose such confidential information to any other Person, except to its auditors, attorneys, financial advisors and other consultants, agents and advisors who need to know such information in connection with Seller’s business (provided that Seller takes reasonable steps to ensure that each such Person maintain the confidentiality required hereunder); provided that the foregoing obligations shall not apply to any such information which comes into the public domain through no fault of Seller, or of any Person to whom Seller is authorized to release or disclose such information, or any information that the recipient of such information independently develops or discovers after the Closing without reference to the disclosed information or breach hereof.

6.3 Conduct Pending the Closing. From the Agreement Date until the earlier of the Closing Date or the termination of this Agreement pursuant to Section 10.1, Seller shall cause the Acquired Assets to be operated in the Ordinary Course of Business in all material respects.

6.4 Filings, Consents and Approvals.

(a) Following delivery of the Option Exercise Notice, Purchaser shall notify Seller whether it believes a filing may be required under any Antitrust Laws. Subject to the terms and conditions set forth in this Agreement, following and contingent upon the exercise of the Option, each of the Parties shall use their respective reasonable best efforts to take, or cause to be taken, all actions, to file, or cause to be filed, all documents and to do, or cause to be done, and to assist and cooperate with the other Party in doing, all things necessary, proper or advisable under applicable Antitrust Laws to consummate and make effective the Transactions as soon as reasonably practicable after exercise of the Option, including (i) the obtaining of all necessary actions or nonactions, waivers, consents, clearances, decisions, declarations, approvals and, expirations or terminations of waiting periods from Governmental Authorities and the making of all necessary registrations and filings and the taking of all steps as may be necessary to obtain any

 

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such consent, decision, declaration, approval, clearance or waiver, or expiration or termination of a waiting period by or from, or to avoid an action or Legal Proceeding by, any Governmental Authority in connection with any Antitrust Laws, (ii) the obtaining of all necessary consents, authorizations, approvals or waivers from Third Parties and (iii) the execution and delivery of any additional instruments necessary to consummate the Transactions.

(b) In furtherance of the foregoing and subject to the terms and conditions set forth in this Agreement, the Parties agree to use reasonable best efforts to take, and cause their Affiliates to use reasonable best efforts to, cause the prompt expiration or termination of any applicable waiting period and to resolve objections, if any, as the FTC or DOJ, or other Governmental Authorities of any other jurisdiction for which consents, permits, authorizations, waivers, clearances, approvals and expirations or terminations of waiting periods are sought with respect to the Transactions, so as to obtain such consents, permits, authorizations, waivers, clearances, approvals or termination of the waiting period under the HSR Act or other Antitrust Laws, and to avoid the commencement of a lawsuit by the FTC, the DOJ, other Governmental Authorities or any other Person under Antitrust Laws, and to avoid the entry of, or to effect the dissolution of, any injunction, temporary restraining order or other order in any suit or proceeding which would otherwise have the effect of preventing the Closing.

(c) Notwithstanding anything to the contrary in this Agreement, nothing shall require or be constructed to require (x) Purchaser or its Affiliates or (y) Seller (and Seller shall not, unless otherwise consented to in writing by Purchaser) to take any action to: (i) commit to or effect, by consent decree, hold separate order or otherwise, the sale, lease, license, divestiture or disposition of any assets, rights, product lines, or businesses of Purchaser or its Affiliates or any of the Acquired Assets, (ii) terminate any Acquired Business Contracts or any existing relationships, contractual rights or obligations of Purchaser or its Affiliates, (iii) terminate any venture or other arrangement, (iv) create any relationship, contractual rights or obligations of Purchaser or any of its Affiliates, (v) effectuate any other change or restructuring of Seller or any of its Affiliates, (vi) undertake or enter into agreements with any Governmental Authority or agree to the entry of an Order by any Governmental Authority, and (vii) otherwise take or commit to take any actions, in the case of Purchaser, with respect to the businesses, product lines or assets Purchaser or any of its Affiliates or, in the case of Seller, any of the Acquired Assets outside of the Ordinary Course of Business.

(d) Subject to the terms and conditions of this Agreement, following and contingent upon the exercise of the Option, upon the determination of Purchaser that any of the following are required, each of the Parties shall (and shall cause their respective Affiliates, if applicable, to): (i) promptly make an appropriate filing of all Notification and Report forms as required by the HSR Act with respect to the Transactions; (ii) promptly make all other filings, notifications or other consents as may be required to be made or obtained by such Party under foreign Antitrust Laws; and (iii) cooperate with each other in determining whether, and promptly preparing and making, any other filings or notifications or other consents required to be made with, or obtained from, any other Governmental Authorities in connection with the Transactions.

 

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(e) Without limiting the generality of anything contained in this Section 6.4, each Party hereto shall use its reasonable best efforts to (i) cooperate in all respects and consult with each other in connection with any filing or submission in connection with any investigation or other inquiry, including allowing the other Party to have a reasonable opportunity to review in advance and comment on drafts of filings and submissions, with respect to the Transactions, (ii) give the other Parties prompt notice of the making or commencement of any request or Legal Proceeding brought by a Governmental Authority or brought by a Third Party before any Governmental Authority, in each case, with respect to the Transactions, (iii) keep the other Parties informed as to the status of any such request or Legal Proceeding, (iv) promptly inform the other Parties of any communication to or from the FTC, DOJ or any other Governmental Authority in connection with any such request or Legal Proceeding, (v) upon request, promptly furnish to the other Parties, subject to an appropriate confidentiality agreement to limit disclosure to outside counsel and consultants retained by such counsel, with copies of documents provided to or received from any Governmental Authority in connection with any such filing, request or Legal Proceeding (documents provided pursuant to this provision may be redacted (1) as necessary to comply with contractual arrangements, (2) to remove references to valuation of Seller and (3) as necessary to address reasonable privilege or confidentiality concerns), (vi) subject to an appropriate confidentiality agreement to limit disclosure to counsel and outside consultants retained by such counsel, and to the extent reasonably practicable, consult in advance and cooperate with the other Parties and consider in good faith the views of the other Parties in connection with any substantive communication, analysis, appearance, presentation, memorandum, brief, argument, opinion or proposal to be made or submitted in connection with any such request or Legal Proceeding and (vii) except as may be prohibited by any Governmental Authority or by any applicable Law, in connection with any such request or Legal Proceeding in respect of the Transactions, each Party hereto shall provide advance notice of and permit authorized Representatives of the other Party to be present at each meeting or conference relating to such request or Legal Proceeding and to have access to and be consulted in advance in connection with any argument, opinion or proposal to be made or submitted to any Governmental Authority in connection with such request or Legal Proceeding. Each Party shall supply as promptly as practicable such information, documentation, other material or testimony that may be reasonably requested by any Governmental Authority, including by complying at the earliest reasonably practicable date with any reasonable request for additional information, documents or other materials, including any “second request” under the HSR Act, received by any Party or any of their respective Subsidiaries from any Governmental Authority in connection with such applications or filings for the Transactions. Purchaser shall pay all filing fees under the HSR Act and for any filings required under foreign Antitrust Laws, but Seller shall bear its own costs for the preparation of any such filings. No Party shall commit to or agree with any Governmental Authority to stay, toll or extend, directly or indirectly, any applicable waiting period with respect to the Transactions under the HSR Act or other applicable Antitrust Laws, or pull and refile under the HSR Act or other applicable Antitrust Laws, in each case, without the prior written consent of the other (such consent not to be unreasonably withheld, conditioned or delayed).

6.5 Further Assurances and Cooperation; Non-Compete.

(a) Further Assurances. Upon the terms and subject to the conditions set forth in this Agreement, each of the Parties agrees to use its commercially reasonable efforts to take, or cause to be taken, all actions, and to do, or cause to be done, and to assist and cooperate with the other Party in doing, all things necessary, proper, or advisable to consummate and make effective, in the most expeditious manner practicable, the Transactions, including using commercially

 

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reasonable efforts to accomplish the following: (i) the obtaining of all necessary actions or nonactions, waivers, consents, and approvals from Governmental Authorities and the making of all necessary registrations and filings (including filings with Governmental Authorities, if any) and recordings of license grants; (ii) the obtaining of all necessary consents, approvals, or waivers from Third Parties required in accordance with the transfer of any Acquired Asset from Seller to Purchaser pursuant to Section 2.1; (iii) the execution and delivery of any additional instruments necessary to consummate the Transactions, and to fully carry out the purposes of, this Agreement and the Related Agreements; and (iv) the identification and delivery of all Acquired Assets not previously identified and delivered.

(b) Cooperation. If, in order to properly prepare any documents or reports required to be filed with any Governmental Authority, it is necessary that either Purchaser or Seller be furnished with additional information, documents, or records relating to the Product Operations, the Acquired Assets, the Excluded Liabilities, or the Assumed Liabilities, and such information, documents, or records are in the possession or control of the other Party, such other Party will use its commercially reasonable efforts to furnish or make available such information, documents, or records (or copies thereof) at the recipient’s reasonable request and at recipient’s cost and expense; provided, further, that the Parties agree that any Party receiving such materials shall be subject to the same obligations of confidentiality described in Section 6.5(c)(i).

(c) Non-Compete.

(i) Seller agrees that, from the Agreement Date until [***] following the Closing Date, it shall not, and shall cause its Affiliates, successors and assigns not to, conduct, participate in, or fund (directly or indirectly), alone or with an Affiliate or Third Party, any Competitive Activities, except as contemplated by this Agreement or the Collaboration Agreement. Seller acknowledges that the time, geographic, and scope limitations of its obligations under this Section 6.5(c) are fair and reasonable in all respects. If any term of this provision is invalid or unenforceable in any jurisdiction, it shall not affect the validity or enforceability of the remaining terms and provisions hereof or the validity or enforceability of the offending term or provision in any other situation or in any other jurisdiction. Further, the Parties agree to replace such invalid or unenforceable term or provision with a valid and enforceable term or provision that will achieve, to the extent possible, the economic, business and other purposes of such invalid or unenforceable term. In addition, Seller will not waive or release any employee from any Contract between Seller and its employees that binds its employees to customary non-compete obligations consistent with this Section 6.5(c) and applicable Law.

(ii) In the event of a Change in Control of Seller, the exclusivity restrictions set forth in Section 6.5(c)(i) shall not apply to any Competitive Activities of the Third Party that is the acquirer in such Change in Control or Affiliates of such Third Party (other than Seller and its Preexisting Affiliates) (collectively, the “Acquiring Parties”) that exist prior to the closing of such Change in Control (“Pre-Existing Competitive Activities”), provided, that (A) no Seller IP is used by or on behalf of Seller, its Preexisting Affiliates or the Acquiring Parties in connection with any Pre-Existing Competing Activities, (B) no Seller IP or other Confidential Information of Seller or its Preexisting Affiliates can be accessed by personnel of such Acquiring Parties involved in performing any Pre-Existing Competitive Activities, and (C) such Acquiring Parties institute sufficient technical and administrative safeguards to ensure the requirements set forth in the foregoing clauses (A) and (B) are met, including by creating “firewalls” between the personnel teams charged with working on any Pre-Existing Competitive Activities.

 

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6.6 Tax Matters.

(a) Allocation. Purchaser and Seller acknowledge and agree that the purchase and sale of the Acquired Assets will be treated for all Tax purposes as a taxable asset purchase. The Consideration (including any Assumed Liabilities, to the extent properly taken into account for income Tax purposes) shall be allocated for US Tax purposes consistently with the allocation schedule prepared by Seller (the “U.S. Allocation Schedule”) and shall be allocated for Irish Tax purposes consistently with the allocation schedule prepared by Purchaser (the “Irish Allocation Schedule”). Neither Party shall file any Tax Return in the U.S. that is inconsistent with the U.S. Allocation Schedule, and neither Party shall file any Tax Return in Ireland that is inconsistent with the Irish Allocation Schedule.

(b) Straddle Period Taxes. In the case of any real or personal property Taxes (or other Taxes imposed on a periodic basis) attributable to the Acquired Assets that are reported on a Tax Return covering a period beginning on or before the Closing and ending thereafter (each, a “Straddle Period Tax”), any such Straddle Period Taxes shall be prorated between Purchaser and Seller on a per diem basis. The Party required by applicable Law to pay any such Straddle Period Tax (the “Paying Party”) shall file the Tax Return related to such Straddle Period Tax within the time period and in the manner required by applicable Law and shall timely pay such Straddle Period Tax. To the extent any such payment exceeds the obligation of the Paying Party hereunder, the Paying Party shall provide the other party (the “Non-Paying Party”) with notice of the amount of such Straddle Period Taxes, and within 10 days of receipt of such notice of payment, the Non-Paying Party shall reimburse the Paying Party for the Non-Paying Party’s share of such Straddle Period Taxes.

(c) Transfer Taxes. All transfer, documentary, sales, use, stamp, value added, goods and services, excise, registration and other similar Taxes, and all conveyance fees, recording charges and other fees and charges (including any penalties and interest) incurred in connection with consummation of the Transactions (“Transfer Taxes”) shall be borne [***]% by Purchaser and [***]% by Seller. The Party required under applicable Laws to file a Tax Return with respect to Transfer Taxes will, at its own expense, prepare or cause to be prepared, and file, or cause to be filed, all necessary Tax Returns and other documentation with respect to such Transfer Taxes, and if required by applicable Law, the Parties will, and will cause their Affiliates to, join in the execution of any such Tax Returns. The Parties agree to reasonably cooperate to minimize any Transfer Taxes to the extent permitted by applicable Law.

(d) Later Imposed Withholding. In the event that Purchaser does not withhold Taxes from a payment to Seller under this Agreement, and a Governmental Authority asserts that such payment was subject to withholding Taxes, Seller agrees to indemnify Purchaser for any withholding Taxes imposed on Purchaser with respect to such payments (except as otherwise provided in Section 3.4 of this Agreement) (collectively “Later Imposed Withholding”). At Purchaser’s election, (1) Purchaser may offset the amount of such Later Imposed Withholding from future payments due to Seller under this Agreement, or (2) Seller shall pay the amount of such Later Imposed Withholding to Purchaser promptly upon request. Promptly following Purchaser withholding any Later Imposed Withholding or Seller remitting any Later Imposed Withholding to Purchaser, Purchaser will (i) pay to the relevant Governmental Authority the amount of such Later Imposed Withholding; and (ii) provide evidence of such payment to Seller on a reasonable and timely basis.

 

 

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(e) Cooperation. To the extent relevant to the Product Operations or the Acquired Assets, each Party shall (i) provide the other with such assistance as may reasonably be requested in connection with the preparation of any Tax Return, claim for refund, and the conduct of any audit or other examination by any Governmental Authority or in connection with judicial or administrative proceedings relating to any Liability for Taxes and (ii) provide the other with all records or other information in its possession that is reasonably requested and may be relevant to the preparation of any Tax Returns, claim for refund, or the conduct of any audit, examination, or other proceeding (including any judicial or administrative proceeding) relating to Taxes (each, a “Tax Contest”). Such cooperation shall include obtaining and providing appropriate forms, retaining and providing records and information that are reasonably relevant to any such Tax Return, claim for refund, or Tax Contest, and making employees available on a mutually convenient basis to provide additional information and explanation of any materials provided hereunder. Notwithstanding the foregoing, no Party shall be required to provide or provide access to any income Tax Returns or related workpapers.

6.7 Employee Matters. Unless Purchaser requests or agrees in writing, no employees of Seller will be transferred to Purchaser in connection with the Transactions. However, Purchaser may consider hiring employees or individual contractors of Seller or its Affiliates who spend a substantial portion of their time on the Product Operations during the Option term or Pre-Closing Period (the “Product Employees”). Upon Purchaser’s written request, during the Pre-Closing Period, Seller shall (i) make reasonable efforts to permit Purchaser to conduct interviews with the Product Employees and (ii) provide to Purchaser compensation and benefits data and performance rankings information with respect to the interviewed employees. If Purchaser determines that it is interested in hiring any of the Product Employees, then prior to the Closing Date, Purchaser may extend to such Product Employees individualized written offers of employment that, if accepted, would contemplate that such Product Employee would commence employment with Purchaser or an Affiliate of Purchaser on the day of the Closing without a lapse in pay. Any such Product Employee who accepts an offer of employment from Purchaser or its Affiliates shall be a “Transferring Employee.” During [***] period commencing on the Closing Date, Seller shall not (and Seller shall ensure that its Affiliates do not) directly or indirectly encourage, induce, attempt to induce, solicit or attempt to solicit any Transferring Employee to leave employment with Purchaser or its Affiliates; provided, however, that Seller and its Affiliates may place general employment solicitations that are not intended to target the Transferring Employees. No provision of this Agreement shall create any third-party beneficiary rights in any current or former employees or consultants of Seller or any Seller Affiliates.

6.8 Escrow Agent. Purchaser shall use commercially reasonable efforts to engage the Escrow Agent as soon as reasonably practicable following the delivery of the Option Exercise Notice and in any event prior to the Closing.

 

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7. CONDITIONS PRECEDENT TO OBLIGATIONS OF PURCHASER.

The obligation of Purchaser to effect the Closing and consummate the Transactions is subject to the satisfaction (or waiver by Purchaser), at or prior to the Closing, of each of the following conditions:

7.1 Accuracy of Representations and Warranties. The representations and warranties of Seller set forth in this Agreement that are qualified as to materiality shall be true and correct, and all other representations and warranties of Seller set forth in this Agreement that are not so qualified shall be true and correct in all material respects, in each case as of the Agreement Date (as qualified by the Initial Schedule) and as of the Closing Date (as qualified by the Updated Schedules), with the same effect as though made as of the Closing Date, except that the accuracy of representations and warranties that by their terms speak as of a specified date will be determined as of such date.

7.2 Performance of Covenants. Seller shall have performed and complied with, in all material respects, all of its covenants contained in this Agreement at or before the Closing (to the extent that such covenants require performance by Seller at or before the Closing).

7.3 No Restraints. No temporary restraining order, preliminary or permanent injunction, or other Order preventing the consummation of any of the Transactions shall have been issued by any court of competent jurisdiction and remain in effect, and no material Law shall have been enacted that makes consummation of any of the Transactions illegal.

7.4 Antitrust Approvals. Any consent, approval or clearance with respect to, or terminations or expiration of any applicable mandatory waiting period (and any extensions thereof) imposed under the HSR Act and under any other applicable Antitrust Laws shall have been received or shall have terminated or expired.

7.5 No Material Adverse Effect. There shall have been no Material Adverse Effect since the Agreement Date that is continuing as of the Closing Date, and no event shall have occurred and no condition or circumstance shall exist that would reasonably be expected to give rise to any such Material Adverse Effect.

7.6 Third Party Consents. Seller shall have obtained all Third Party consents for the transfer or novation to Purchaser of all Acquired Business Contracts and such consents shall be in full force and effect.

7.7 No Governmental Litigation. There shall not be pending or threatened in writing before any court of competent jurisdiction or other Governmental Authority any Action (a) to which a Governmental Authority is a party, and (b) that would or would reasonably be expected to (i) restrain, enjoin, prevent, prohibit or make illegal the consummation of the Transactions or result in damages to Purchaser or any of its Affiliates in connection with the Transactions, or (ii) prohibit or limit the ownership or operation by Purchaser, its Affiliates of the Acquired Assets or the Assumed Liabilities, or (iii) compel Purchaser or its Affiliates to dispose of, hold separate or license any material portion of the business or assets (including the Acquired Assets) of Purchaser or its subsidiaries, as a result of the Transactions.

 

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7.8 Closing Certificate. Seller shall have delivered to Purchaser a certificate to the effect that each of the conditions specified above in Sections 7.1, 7.2 and 7.5 is satisfied in all respects as of the Closing (the “Seller Closing Certificate”).

7.9 Option Exercise Notice. Purchaser shall have delivered an Option Exercise Notice to Seller in accordance with the Collaboration Agreement.

7.10 Related Agreements. Seller shall have executed and delivered to Purchaser (or caused one or more of its Affiliates to execute and deliver to Purchaser, as applicable) each of the Related Agreements.

8. CONDITIONS PRECEDENT TO OBLIGATION OF SELLER.

The obligation of Seller to effect the Closing and consummate the Transactions is subject to the satisfaction (or waiver by Seller), at or prior to the Closing, of the following conditions:

8.1 Accuracy of Representations. The representations and warranties of Purchaser set forth in this Agreement that are qualified as to materiality shall be true and correct, and all other representations and warranties of Purchaser set forth in this Agreement that are not so qualified shall be true and correct in all material respects.

8.2 Performance of Covenants. Purchaser shall have performed and complied with, in all material respects, all of its covenants contained in this Agreement at or before the Closing (to the extent that such covenants require performance by Purchaser at or before the Closing).

8.3 No Restraints. No temporary restraining order, preliminary or permanent injunction, or other Order preventing the consummation of any of the Transactions by Seller shall have been issued by any court of competent jurisdiction and remain in effect, and no material Law shall have been enacted that makes consummation of any of the Transactions illegal.

8.4 Antitrust Approvals. Any consent, approval or clearance with respect to, or terminations or expiration of any applicable mandatory waiting period (and any extensions thereof) imposed under the HSR Act and under any other applicable Antitrust Laws shall have been received or shall have terminated or expired.

8.5 Closing Certificate. Purchaser shall have delivered to Seller a certificate to the effect that each of the conditions specified above in Sections 8.1 and 8.2 is satisfied in all respects.

8.6 Option Exercise Notice. Purchaser shall have delivered an Option Exercise Notice to Seller in accordance with the Collaboration Agreement.

8.7 Related Agreements. Purchaser shall have executed and delivered to Seller each of the Related Agreements.

9. INDEMNIFICATION.

9.1 Indemnification by Seller and Purchaser.

 

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(a) Indemnification by Seller. Subject to the terms and conditions of this Agreement, Seller will indemnify and hold harmless Purchaser, its Affiliates, and their respective officers, directors, managers, employees, agents, successors, and permitted assigns (collectively, the “Purchaser Indemnified Parties”) against and in respect of any Losses suffered or incurred by any Purchaser Indemnified Party resulting from or arising out of any of the following:

(i) any breach or inaccuracy of any representation or warranty of Seller contained in this Agreement or the Disclosure Schedules as of the Schedule Delivery Date or as of the Closing Date (as if given on the Closing Date), taking into account the Initial Schedules and, with respect to any representation or warranty made as of the Schedule Delivery Date or the Closing Date, the Updated Schedules, (in each case, except to the extent expressly made as of a specified date, in which case as of such date) and without giving effect to any materiality, Material Adverse Effect or similar qualifications limiting the scope of such representation or warranty;

(ii) any breach of or failure to perform any covenant, agreement, or obligation of Seller in this Agreement or the Collaboration Agreement;

(iii) any Excluded Liabilities, including Seller Tax Liabilities;

(iv) any Liability (other than the Assumed Liabilities) to which Purchaser or any of the other Purchaser Indemnitees may become subject and that arises from or relates to (A) the operation by Seller of its business, with respect to the Product Operations prior to the Closing, including any Liability arising from any Clinical Trials conducted by or for Seller prior to the Closing, or (B) any failure by Seller to comply with any bulk transfer law or similar Law in connection with any of the Transactions;

(v) any Fraud in connection with this Agreement or any Related Agreement; or

(vi) any Proceeding commenced by a Purchaser Indemnified Party for the purpose of enforcing any of its rights under this Section 9.1(a) and in which such Purchaser Indemnified Party is the prevailing party.

(b) Indemnification by Purchaser. Subject to the terms and conditions of this Agreement, Purchaser will indemnify and hold harmless Seller and its Affiliates and their respective officers, directors, managers, employees, agents, successors, and permitted assigns (collectively, the “Seller Indemnified Parties”) against and in respect of any Losses suffered or incurred by any Seller Indemnified Party resulting from or arising out of any of the following:

(i) any breach or inaccuracy of any representation or warranty of Purchaser contained in this Agreement or the Disclosure Schedules, as of the Schedule Delivery Date or as of the Closing Date (as if given on the Closing Date) (in each case, except to the extent expressly made as of a specified date, in which case as of such date) and without giving effect to any materiality, material adverse effect or similar qualifications limiting the scope of such representation or warranty;

(ii) any breach of or failure to perform any covenant, agreement, or obligation of Purchaser in this Agreement or the Collaboration Agreement;

 

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(iii) the operation by Purchaser of the Product Operations, following the Closing;

(iv) the Assumed Liabilities; or

(v) any Fraud in connection with this Agreement or any Related Agreement; or

(vi) any Legal Proceeding commenced by a Seller Indemnified Party for the purpose of enforcing any of its rights under this Section 9.1(b) and in which such Seller Indemnified Party is the prevailing party.

9.2 Survival.

(a) All representations and warranties contained in Article 5 of this Agreement (including the related portions of the Disclosure Schedules) will survive the Closing for a period ending [***] after the Closing Date, at which time they shall terminate, are void, and of no further force or effect; provided, the foregoing shall not apply to (i) the Fundamental Representations, which shall survive the Closing until 11:59 pm (Eastern time) on the date that is 90 days following the expiration of the longest applicable statute of limitations (including any extensions thereof) or (ii) the IP Representations, which IP Representations will survive for three years following the Closing Date. The covenants in this Agreement and the covenants in the Collaboration Agreement shall survive Closing and continue in effect and expire in accordance with their respective terms; provided, that, any Claim for Losses with respect to any covenants that expire at or prior to the Closing shall survive for a period ending [***] following the Closing Date.

(b) Notwithstanding the foregoing, any Fraud committed in connection with this Agreement will survive the Closing without limitation as to time.

(c) No indemnification will be payable for any Claim for Losses pursuant to Sections 9.1(a)(i) or 9.1(b)(i) with respect to any inaccuracy or breach of any representation or warranty after termination of the applicable survival period specified in this Section 9.2, except with respect to Claims made prior to such termination pursuant to Section 9.5 but not then resolved (such representation or warranty surviving with respect to such Claim until resolution of such Claim), or with respect to any covenants after the termination of the applicable survival period. The limitations set forth in this Section 9.2(c) shall not apply to any Claim for Losses pursuant to Sections 9.1(a)(iii), 9.1(a)(iv), 9.1(a)(v), 9.1(a)(vi), 9.1(b)(iii), 9.1(b)(v), or 9.1(b)(vi) regardless of whether such Claim also may be described in other subsections of Section 9.1(a) or Section 9.1(b), provided, however, that there shall not be any multiple recovery for any Losses for all purposes of this Agreement, or multiple recovery for duplicate Losses under this Agreement, the Collaboration Agreement or any Related Agreement.

9.3 Limitations. The rights to indemnification are subject to the following limitations:

(a) Cap. The aggregate amount which all of the Purchaser Indemnified Parties will be entitled to receive (i) for all Claims under Section 9.1(a)(i) (other than with respect to any misrepresentation or breach of any Fundamental Representations or any IP Representations) shall not exceed (i) the Escrow Amount and (ii) for all Claims under Section 9.1(a)(i) with respect to

 

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any misrepresentation or breach of any Fundamental Representations or any IP Representations and for all Claims under Section 9.1(a)(ii) shall not exceed (A) the Escrow Amount, plus (B) the Closing Payment, plus (C) the amount of the [***], to the extent the [***] is not paid by [***], plus (D) the amount of any Milestone Payments or Royalties (or portion thereof) that are paid or become payable, which Claims shall be satisfied first, for as long as there are remaining funds in the Escrow Account, from the Escrow Amount and second, to the extent that any Milestone Payments or Royalties are then payable to Seller under Section 3.3, pursuant to the setoff right set forth in Section 9.4.

(b) Deductible. Seller will have no obligation to indemnify any Purchaser Indemnified Parties for any Claims under Section 9.1(a)(i) (other than Section 9.1(a)(i) with respect to any misrepresentation or breach by Seller of any Fundamental Representations or any IP Representations for which the Deductible will not apply) until the aggregate amount of all Losses incurred by the Purchaser Indemnified Parties for which a Claim is brought under Section 9.1(a)(i) exceeds $[***] (the “Deductible”), and to the extent such Losses exceed the Deductible such Purchaser Indemnified Party shall be entitled to recover all such Losses in excess of the amount of the Deductible.

(c) Exclusions from Limitations. The limitations under Section 9.3(a) will not apply with respect to any Claims for indemnification arising under Sections 9.1(a)(iii)- through 9.1(a)(vi), the aggregate amount of which shall not be capped, regardless of whether such Claim(s) also may be described in any other subsection of Section 9.1(a).

(d) Other Limitations. Notwithstanding anything to the contrary contained in this Agreement or otherwise, the Parties expressly intend and agree as follows:

(i) The amount of any Losses incurred by the Indemnified Party shall be reduced by any amount actually recovered by such Indemnified Party with respect thereto under any insurance coverage (net any costs and expenses, including deductibles, costs of recovery and the amount of any insurance premium increases).

(ii) Each Indemnified Party shall use commercially reasonable efforts to, and shall cause its Affiliates to use commercially reasonable efforts to, mitigate any Losses for which it seeks indemnification under this Article 9; provided, however, that no such Indemnified Party shall be required to take any action or refrain from taking any action that is contrary to any applicable Contract or Laws binding on such Indemnified Party or any Affiliate thereof, make any insurance claims or commence litigation against any Third Party.

(iii) The indemnification provisions provided for in this Article 9 will be the exclusive remedy for any breach of any representation, warranty, covenant, or agreement contained in this Agreement; provided, however, that nothing in this Agreement shall limit the rights or remedies of any Indemnified Party in connection with (A) Fraud or (B) seeking any equitable remedies.

(iv) Seller shall have no obligation to indemnify the Indemnified Parties for any Losses attributable to Taxes for any taxable period (or portion thereof) beginning after the Closing Date.

 

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9.4 Right to Set-Off. Subject to all of the other restrictions and limitations contained in this Article 9 and in addition to any rights of set-off or other similar rights that Purchaser or any other Indemnified Party may have at common law or otherwise, Purchaser shall have the right, but not the obligation, to withhold from any unpaid future Milestone Payments and/or Royalties due and payable to Seller the amount of Losses described in any then-pending indemnification Claims made by any of the Purchaser Indemnified Parties pursuant to Section 9.5 (i.e., Purchaser may withhold an aggregate amount from any Milestone Payments and/or Royalties up to 100% of the amount of its Losses under any such indemnification Claims, subject to the limitations set forth in Section 9.3). If the final amount of such Losses is determined in accordance with this Article 9 to be less than the amounts withheld from the Milestone Payments and/or Royalties, then Purchaser shall promptly, and in any event within 15 Business Days following the final determination of the amount of such Losses, deliver the difference to Seller. If the final amount of such Losses is finally determined to exceed the amount by which the Milestone Payments and/or Royalties were reduced for such Claim, then Purchaser shall continue to be entitled to indemnification for the amount of such excess subject to the limitations set forth in this Article 9.

9.5 Resolution of Indemnification Disputes. In order to seek indemnification under this Article 9, the Indemnified Party shall deliver a Claim Notice to the Indemnifying Party which contains (a) a description and the amount, if known, of any Losses incurred or reasonably expected to be incurred by the Indemnified Party (which shall be calculated and estimated by the Indemnified Party in good faith), (b) a statement that the Indemnified Party is entitled to indemnification under this Article 9 for such Losses and a reasonable explanation of the basis therefor, and (c) a demand for payment in the amount of such Losses. Upon reasonable request, the Indemnified Party shall furnish the Indemnifying Party with any information to the extent that such information is reasonably necessary in order to evaluate the Claim Notice and the underlying Claims. If an Indemnifying Party disputes or contests the basis or amount of any Claim set forth in a Claim Notice delivered by an Indemnified Party in accordance with the provisions of Article 9, the dispute will be resolved as set forth below:

(a) An Indemnifying Party may object to a Claim for indemnification set forth in Claim Notice by delivering to the Indemnified Party seeking indemnification a written statement of objection to the Claim made in the Claim Notice (an “Objection Notice”); provided, however, that, to be effective, such Objection Notice must (i) be delivered to the Indemnified Party prior to the 30th day following the receipt of the applicable Claim Notice (such deadline, the “Objection Deadline” for such Claim Notice and the Claims for indemnification contained therein) and (ii) set forth in reasonable detail the nature of the objections to the Claims in respect of which the objection is made.

(b) To the extent the Indemnifying Party does not object in writing (as provided in Section 9.5(a)) to the Claims contained in such Claim Notice prior to the Objection Deadline for such Claim Notice, such failure to so object shall be an irrevocable acknowledgment by the Indemnifying Party that the Indemnified Party is entitled to the full amount of the Claims for Losses set forth in such Claim Notice (and such entitlement shall be conclusively and irrefutably established) (or, in the case of any notice in which the Losses (or any portion thereof) are estimated, the amount of such Losses (or such portion thereof) as finally determined) with respect to the applicable parties against the Indemnifying Party (any such Claim, an “Unobjected Claim”). Within 30 days of a Claim becoming an Unobjected Claim, the Indemnifying Party shall make the

 

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applicable payment to such Indemnified Party, subject to the limitations set forth in this Article 9 (provided, that, if all or any portion of such amount is to be recovered from the Escrow Account, Purchaser and Seller shall execute a joint written instruction directing the Escrow Agent to deliver such amount to the Indemnified Party).

(c) In case an Indemnifying Party timely delivers an Objection Notice in accordance with Section 9.5(a), the Indemnifying Party and the Indemnified Parties shall attempt in good faith to agree upon the rights of the respective parties with respect to each of such Claims. If the Indemnifying Party and the Indemnified Parties reach an agreement, a written memorandum setting forth such agreement shall be prepared and signed by all applicable parties (any Claims covered by such an agreement, “Settled Claims”). Any amounts required to be paid as a result of a Settled Claim shall be paid by the Indemnifying Party to the Indemnified Parties pursuant to the Settled Claim within 30 days of the applicable Claim becoming a Settled Claim (provided, that, if all or any portion of such amount is to be recovered from the Escrow Account, Purchaser and Seller shall execute a joint written instruction directing the Escrow Agent to deliver such amount to the Indemnified Party).

(d) If no such agreement can be reached after good faith negotiation prior to 45 days after delivery of an Objection Notice, then upon the expiration of such 45-day period either the Indemnifying Party or the Indemnified Parties may seek to resolve such dispute pursuant to Section 11.1(b) and upon such resolution if all or any portion of such disputed amount is to be recovered from the Escrow Account, Purchaser and Seller shall execute a joint written instruction directing the Escrow Agent to deliver such amount to the Indemnified Party.

9.6 Third Party Claim Procedures.

(a) Notice. If an Indemnified Party shall become aware of an indemnifiable matter arising from any pending or threatened Legal Proceeding by or against a Third Party (each such action or suit being a “Third Party Claim”), the Indemnified Party shall promptly, and in any event within 30 days after it first becomes aware of facts which give rise to the basis for such claim, give written notice (a “Third Party Notice”) to the applicable Indemnifying Party of the basis for such Third Party Claim, which notice shall set forth the nature of the Third Party Claim, including, if known, the estimated amount of such claim in reasonable detail and including copies of any documents served on the Indemnified Party with respect to such Third Party Claim. Notwithstanding the foregoing, failure to notify the Indemnifying Party in accordance with this Section 9.6(a) will not relieve the Indemnifying Party of any obligation that it may have to the Indemnified Party except to the extent the defense of such Third Party Claim is actually and materially prejudiced by the Indemnified Party’s failure to give such notice.

(b) Control. The Indemnifying Party, upon notice to the Indemnified Party, shall have the right to assume and control the defense of such Third Party Claim for which the Indemnifying Party is obligated to indemnify pursuant to this Article 9 at its own cost and through counsel of its choosing; provided, however, that the Indemnifying Party shall not have the right to assume and control such defense: (i) if such Third Party Claim involves criminal allegations, (ii) if outside counsel advises in writing the Indemnified Party that a reasonable likelihood exists of a conflict of interest between the Indemnifying Party and the Indemnified Party with respect to the Third Party Claim that cannot be waived, (iii) if such Third Party Claim seeks relief other than

 

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monetary damages, (iv) if the Indemnifying Party failed or is failing to diligently prosecute or defend with respect to such Third Party Claim and is provided with written notice of such failure by the Indemnified Party, and such failure is not reasonably cured within a reasonable period of time, or (v) if Seller is the Indemnifying Party and the Third Party Claim primarily relates to any Product IP. The Indemnifying Party shall from time to time apprise the Indemnified Party of the status of the Third Party Claim and any resulting Legal Proceeding and shall furnish the Indemnified Party with such documents and information filed or delivered in connection with such Third Party Claim as the Indemnified Party may reasonably request. The Indemnified Party shall not admit any liability to any Third Party in connection with any matter which is the subject of a Third Party Notice and shall cooperate fully in the manner requested by the Indemnifying Party in the defense of such claim.

(c) Indemnified Party. Notwithstanding anything herein stated, the Indemnified Party shall at all times have the right to fully participate in such defense at its own expense directly or through counsel. If no such notice of intent to defend is given by the Indemnifying Party, the Indemnified Party shall, at the expense of the Indemnifying Party, undertake (with counsel selected by the Indemnified Party and reasonably acceptable to the Indemnifying Party) the defense of such Third Party Claim and shall have the right to compromise or settle such Third Party Claim with the consent of the Indemnifying Party, which consent shall not be unreasonably withheld, conditioned, or delayed. The Indemnified Party shall furnish the Indemnifying Party with such information as it may have with respect to such Third Party Claim (including copies of any summons, complaint or other pleading which may have been served on such party and any written claim, demand, invoice, billing or other document evidencing or asserting the same) and shall otherwise cooperate with and assist the Indemnifying Party in the defense of such Third Party Claim.

(d) Additional Right. If the Indemnifying Party is not, or becomes not, entitled to assume the defense of such Third Party Claim or withdraws from such defense, the Indemnified Party shall have the right to undertake the defense or settlement thereof, at the Indemnified Party’s expense, subject to the final determination of whether such expenses are indemnifiable Losses. If the Indemnified Party controls the defense of any Third Party Claim pursuant to this Section 9.6(d), the Indemnified Party shall keep the Indemnifying Party reasonably and timely apprised of all developments in and the status of such Third Party Claim, and, such Indemnified Party shall have the right to compromise or settle such Third Party Claim as indemnifiable Losses with the consent of the Indemnifying Party, which consent shall not be unreasonably withheld, conditioned or delayed; provided, that, if the Indemnified Party settles, in good faith, any Third Party Claim without the Indemnifying Party’s consent (and the absence of the consent was not due to the Indemnifying Party unreasonably withholding or conditioning its consent), then any such settlement of a Third Party Claim by the Indemnified Party not consented to by an Indemnifying Party shall not be determinative of the validity or the amount of Losses with respect to any claim for indemnification by such Indemnifying Party under this Article 9. The existence of any Third Party Claim shall not create a presumption of any breach by a Party of any of its representations, warranties, or covenants set forth in this Agreement. If an Indemnified Party controls any such Third Party Claim, the Indemnifying Party shall be entitled to participate in the defense or handling of such Third Party Claim with its own counsel and at its own expense.

 

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9.7 Tax Treatment of Indemnification Payments. For all purposes hereunder, any indemnification payments made pursuant to Article 9 will be treated as an adjustment to the Consideration, except as otherwise required by applicable Law.

10. TERMINATION.

10.1 Automatic Termination. Notwithstanding anything contained in this Agreement to the contrary, unless earlier terminated pursuant to Section 10.2 or Section 2.5 of the Collaboration Agreement, this Agreement will automatically terminate on the Option Termination Date.

10.2 Termination of the Agreement. This Agreement may be terminated, and the Transactions may be abandoned, by written notice delivered by the terminating Party to the other Party (other than in the case of Section 10.2(a)) at any time prior to the Closing:

(a) by the mutual written agreement of Purchaser and Seller;

(b) by either Purchaser or Seller if any Governmental Authority of competent jurisdiction issues an Order permanently restraining, enjoining, or otherwise prohibiting the consummation of the Transactions, and such Order becomes final and non-appealable; provided, however, that the right to terminate this Agreement under this Section 10.2(b) shall not be available to a Party whose failure to perform its covenants or agreements contained in this Agreement has been the cause of or has resulted in the imposition of such Order or the failure of such Order to be resisted, resolved, or lifted;

(c) by either Party if the other Party breaches or fails to perform in any material respect any of its representations, warranties, covenants, or agreements contained in this Agreement, which breach or failure to perform, (i) if capable of being cured, has not been cured by the date that is [***] after receipt of written notice thereof from Purchaser, or (ii) is incapable of being cured; or by either Party by written notice to the other if the consummation of the Transactions contemplated hereby shall not have occurred on or before the date that is [***] following the Option Exercise Date, which date may be extended by either Party for up to [***] if any consents, approvals or clearances with respect to, or terminations or expiration of any applicable mandatory waiting period (and any extensions thereof) imposed under the HSR Act and under any other applicable Antitrust Laws have not been obtained by such date (the “Outside Date”); provided, that the right to terminate this Agreement under this Section 10.2(c) shall not be available to any Party then in material breach of its representations, warranties, covenants or other agreements under this Agreement;

(d) by Purchaser upon termination or expiration of the Option; or

(e) by Purchaser, upon written notice to Seller, at any time after the expiration of the Company Delivery Period if Seller has not delivered the Updated Schedules to Purchaser prior to the expiration of the Company Delivery Period.

 

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10.3 Effect of Termination. In the event of termination by either Party pursuant to Section 10.1, written notice thereof will forthwith be given to the other Party and the Transactions will be terminated, without further action by either Party. If the Transactions are terminated as provided herein, this Agreement shall become null and void and have no further force and effect and all obligations of the Parties under this Agreement shall terminate and there shall be no liability of any Party to any other Party, except that nothing herein will relieve or release any Party from liability arising from any breach by such Party of this Agreement prior to any such termination. Notwithstanding the foregoing, the following Sections of this Agreement shall remain in full force and effect: Section 6.2, this Section 10.3, and Article 11.

11. MISCELLANEOUS.

11.1 Governing Law; Dispute Resolution.

(a) Governing Law. This Agreement shall be governed by and construed and enforced under the substantive laws of the State of New York, excluding (i) any conflicts or choice of law rule or principle that might otherwise make this Agreement subject to the substantive law of another jurisdiction; (ii) the United Nations Conventions on Contracts for the International Sale of Goods; (iii) the 1974 Convention on the Limitation Period in the International Sale of Goods; and (iv) the Protocol amending the 1974 Convention, done at Vienna April 11, 1980.

(b) Dispute Resolution.

(i) General. Unless otherwise set forth in this Agreement, in the event of any dispute in connection with this Agreement, such dispute shall be referred to the respective Executive (as defined in the Collaboration Agreement) of the Parties or their designees, for good faith negotiations attempting to resolve the dispute.

(ii) Referral to Executives. Should the Executives of the parties be unable to resolve such dispute within two months after such dispute has first been referred to them, either Party may pursue any remedy available to such party at law or in equity, subject to the terms and conditions of this Agreement. Purchaser and Seller each hereby irrevocably: (i) consents to submit itself in any suit, action or proceeding arising out of or related to this Agreement or any of the transactions contemplated hereby to the exclusive personal jurisdiction of the courts of the State of New York sitting in New York County, New York; (ii) agrees that it will not attempt to defeat or deny such personal jurisdiction by motion or other request for leave from such court; and (iii) agrees that it will not bring any action arising out of or related to this Agreement or any of the transactions contemplated hereby in any court other than any such court.

11.2 Specific Performance. Subject to Section 9.3(d)(iii), the Parties agree that irreparable damage would occur in the event that any of the terms or provisions of this Agreement were not performed in accordance with their specific wording or were otherwise breached. The Parties accordingly agree that, in the event of any breach or threatened breach by any Party of any covenant, obligation or other provision set forth in this Agreement, for the benefit of any other Party: (a) such other Party shall be entitled (in addition to any other remedy that may be available to it) to: (i) a decree or order of specific performance or mandamus to enforce the observance and performance of such covenant, obligation or other provision; and (ii) an injunction restraining such breach or threatened breach; and (b) such other Party shall not be required to provide any bond or other security in connection with any such decree, order or injunction or in connection with any related Legal Proceeding.

 

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11.3 WAIVER OF JURY TRIAL. EACH OF PURCHASER AND SELLER HEREBY IRREVOCABLY AND UNCONDITIONALLY WAIVES ALL RIGHT TO TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM (WHETHER BASED ON CONTRACT, TORT OR OTHERWISE) ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE ACTIONS OF PURCHASER AND SELLER IN THE NEGOTIATION, ADMINISTRATION, PERFORMANCE AND ENFORCEMENT HEREOF.

11.4 Entire Agreement; Severability. This Agreement, together with the Disclosure Schedules, Related Agreements, all Exhibits and Schedules hereto and thereto constitute the entire agreement, and supersede all prior agreements and understandings, both written and oral, between the Parties with respect to the subject matter hereof and thereof, including the Confidentiality Agreements. If any term, condition or other provision of this Agreement is found to be invalid, illegal or incapable of being enforced by virtue of any rule of law, public policy or court determination, all other terms, conditions and provisions of this Agreement shall nevertheless remain in full force and effect. If the final determination of any arbitration process or final judgment of a court of competent jurisdiction, in each case, to the extent in accordance with the terms of this Agreement, declares that any term or provision hereof is invalid or unenforceable, the arbitrators or court making the determination of invalidity or unenforceability shall have the power to limit the term or provision, to delete specific words or phrases, or to replace any invalid or unenforceable term or provision with a term or provision that is valid and enforceable and that comes closest to expressing the intention of the invalid or unenforceable term or provision, and this Agreement shall be enforceable as so modified.

11.5 Incorporation by Reference. The Disclosure Schedules, the Schedules and Exhibits, and the documents referenced herein and therein constitute integral parts of this Agreement and are hereby incorporated by reference herein.

11.6 Amendments and Waivers. This Agreement may not be amended or modified, nor may compliance with any condition or covenant set forth herein be waived, except by a writing duly and validly executed by Purchaser or Seller or, in the case of a waiver, the party waiving compliance. Except as specifically set forth herein to the contrary, no delay or omission by either party in exercising any right or power occurring upon any noncompliance or default by the other party with respect to any of the terms of this Agreement shall impair any such right or power or be construed to be a waiver thereof. A waiver by either party of any of the covenants, conditions or agreements to be performed by the other shall not be construed to be a waiver of any succeeding breach thereof or of any other covenant, condition or agreement herein contained.

11.7 Notices. Any notice or other communication required or permitted to be delivered to any party under this Agreement shall be in writing and shall be deemed properly delivered, given and received (a) upon receipt when delivered by hand, (b) upon transmission, if sent by electronic transmission (in each case with receipt verified by electronic confirmation) or (c) one Business Day after being sent by courier or express delivery service, provided that in each case the notice or other communication is sent to the address set forth beneath the name of such party below (or to such other address as such party shall have specified in a written notice given to the other Party):

 

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  (1)

If to Seller, to:

Q32 Bio Inc.

Attn: Michael Broxson, CEO

830 Winter Street, 2nd Floor

Waltham, MA 02451

with required copies to:

Goodwin Procter LLP

Attn: Kingsley L. Taft and Laurie A. Burlingame

100 Northern Avenue

Boston, MA 02210

 

  (2)

If to Purchaser, to:

Horizon Therapeutics Ireland DAC

70 St. Stephen’s Green

Dublin 2, D02 E2X4

Ireland

Attention: General Counsel

with required copies to:

Horizon Therapeutics USA, Inc.

Horizon Way

Deerfield, IL 60015

USA

Attention: General Counsel

and

Cooley LLP

4401 Eastgate Mall

San Diego, CA 92121

USA

Attention: Barbara Borden, L. Kay Chandler

e-mail: [***]

11.8 No Assignment; Binding Effect. Neither this Agreement nor any of the rights, interests or obligations under this Agreement may be assigned, in whole or in part, by either Purchaser or Seller without the prior written consent of the other Party; provided, that, (a) Purchaser may assign this Agreement to any of its Affiliates or to a successor in interest in connection with the merger, consolidation, or sale of all or substantially all of its assets or that portion of its business pertaining to the subject matter of this Agreement, (b) Seller may assign this Agreement to a successor in interest in connection with the merger, consolidation, or sale of all or substantially all of its assets or that portion of its business pertaining to the subject matter of this Agreement, and (c) no assignment shall relieve either Party of its obligations hereunder. Any assignment in violation of the preceding sentence will be null and void. This Agreement will be binding upon, inure to the benefit of, and be enforceable by, the Parties and their respective successors and permitted assigns.

 

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11.9 Third Person Beneficiaries. Except as provided in Article 9, this Agreement shall not benefit or create any right or cause of action in or on behalf of any Person other than the Parties and their respective successors and permitted assigns and nothing herein, whether express or implied, is intended to or shall confer upon any other Person any legal or equitable right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.

11.10 Relationship of the Parties. Nothing contained in this Agreement shall be deemed or construed to create a partnership, joint venture, employment, franchise, agency or fiduciary relationship between Purchaser and Seller. Neither party shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other party or to bind the other party to any contract, agreement or undertaking with any Third Party.

11.11 Headings; Interpretation. The headings in this Agreement are intended solely for convenience of reference and will be given no effect in the construction or interpretation of this Agreement. Unless the context otherwise requires, the singular includes the plural, and the plural includes the singular. Whenever the words “include”, “includes”, or “including” are used in this Agreement, they are deemed to be followed by the words “without limitation”. Unless otherwise specified, references in this Agreement to any Article shall include all Sections, subsections, and paragraphs in such Article, references to any Section shall include all subsections and paragraphs in such Section, and references in this Agreement to any subsection shall include all paragraphs in such subsection. The word “or” means “and/or” unless the context dictates otherwise because the subjects of the conjunction are mutually exclusive. The words “herein”, “hereof”, and “hereunder” and other words of similar import refer to this Agreement as a whole and not to any particular Section or other subdivision. All references to days in this Agreement mean calendar days, unless otherwise specified. Ambiguities and uncertainties in this Agreement, if any, shall not be interpreted against either Party, irrespective of which Party may be deemed to have caused the ambiguity or uncertainty to exist. This Agreement has been prepared in the English language and the English language shall control its interpretation.

11.12 Counterparts; Signatures. This Agreement may be executed in one or more counterparts, all of which will be considered one and the same agreement and will become effective when one or more counterparts have been signed by each of the Parties and delivered to the other Party. This Agreement may be executed by facsimile signature or by an electronic scan delivered by electronic mail.

11.13 Expenses. Except as otherwise expressly provided in this Agreement, whether or not the Transactions are consummated, each Party hereto will pay its own costs and expenses incurred incident to its negotiation and preparation of this Agreement and the Related Agreements and to its performance and compliance with all agreements and conditions contained herein and therein on its part to be performed or complied with, including the fees, expenses and disbursements of its counsel and accountants.

{Signature Page to Follow}

 

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IN WITNESS WHEREOF, the Parties, intending legally to be bound, have caused this Asset Purchase Agreement to be duly executed and delivered as of the Agreement Date.

 

Q32 BIO INC.

By:

 

/s/ Michael Broxson

Print Name: Michael Broxson

Title:

 

CEO

{Signature Page to Asset Purchase Agreement}


IN WITNESS WHEREOF, the Parties, intending legally to be bound, have caused this Asset Purchase Agreement to be duly executed and delivered as of the Agreement Date.

 

HORIZON THERAPEUTICS IRELAND DAC

By:

 

/s/ William D. Gannon

Print Name: William D. Gannon

Title:

 

Director

{Signature Page to Asset Purchase Agreement}


EXHIBIT A

Form of Assignment and Assumption Agreement

[Intentionally Omitted]


EXHIBIT B

Form of Bill of Sale

[Intentionally Omitted]


EXHIBIT C

Transition Services Agreement

[Intentionally Omitted]

Exhibit 10.37

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,

MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND IS

THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

COLLABORATION

AND

OPTION AGREEMENT

dated as of August 12, 2022

by and between

Q32 BIO INC.

and

HORIZON THERAPEUTICS IRELAND DAC


TABLE OF CONTENTS

 

          Page  
Article I    DEFINITIONS      2  

1.1

   Definitions      2  

1.2

   Interpretation      12  
Article II    GOVERNANCE; JOINT STEERING COMMITTEE      12  

2.1

   Joint Steering Committee Formation; Composition      12  

2.2

   Responsibilities and Authority      12  

2.3

   Meetings; Minutes      14  

2.4

   Subcommittees      14  

2.5

   Decision-Making; Dispute Resolution      15  

2.6

   Limitation on Authority      16  

2.7

   Alliance Manager      17  
Article III    DEVELOPMENT PROGRAM      17  

3.1

   Development Plan      17  

3.2

   Performance of Development Program      17  

3.3

   Funding of Development Program      17  

3.4

   Regulatory Responsibilities      18  

3.5

   Reports; Records; Audit      19  

3.6

   Intellectual Property      20  

3.7

   Preparation and Delivery of Option Package      22  

3.8

   Exclusivity      23  

3.9

   Step-In Rights      24  
Article IV    OPTION; DELIVERIES      24  

4.1

   Grant of Option      24  

4.2

   Horizon’s Deliveries      25  

4.3

   The Company’s Deliveries      25  

4.4

   Option Exercise      25  
Article V    FINANCIAL TERMS      27  

5.1

   Option Fee      27  

5.2

   Development Funding      27  

5.3

   VAT on Payments      27  

5.4

   Withholding Tax; Cooperation      27  

5.5

   Later Imposed Withholding      28  

 

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TABLE OF CONTENTS

(continued)

 

          Page  
Article VI    REPRESENTATIONS AND WARRANTIES OF THE COMPANY      28  

6.1

   Due Organization      28  

6.2

   Authority; Binding Nature of Agreement      28  

6.3

   No Conflict, Consents      29  

6.4

   Consents and Approvals      29  

6.5

   Title to Assets      30  

6.6

   No Proceedings      30  

6.7

   No Other Representations or Warranties      30  
Article VII    REPRESENTATIONS AND WARRANTIES OF HORIZON      30  

7.1

   Organization and Authority      30  

7.2

   Consents and Approvals      31  

7.3

   Funding      31  

7.4

   No Proceedings      31  

7.5

   No Other Representations or Warranties      31  
Article VIII    ACTION PRIOR TO THE OPTION TERMINATION      31  

8.1

   Investigation by Horizon; Information Rights      31  

8.2

   Notification of Certain Matters      32  

8.3

   Covenants of the Company During the Pre-Closing Period      32  

8.4

   Restrictions on Conduct of Business by the Company      34  

8.5

   Acquisition Proposal      36  

8.6

   Financial Information      36  

8.7

   Required Post-Signing Third Party Consents      36  
Article IX    INDEMNIFICATION      36  

9.1

   Indemnification by the Company      36  

9.2

   Limitations      37  

9.3

   Notice of Claims      37  

9.4

   Indemnification Procedures      38  

9.5

   Tax Treatment of Indemnification Payments      39  

 

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TABLE OF CONTENTS

(continued)

 

          Page  
Article X    TERMINATION      39  

10.1

   Automatic Termination      39  

10.2

   Early Termination      39  

10.3

   Effect of Termination      40  
Article XI    CONFIDENTIALITY      40  

11.1

   Confidentiality      40  

11.2

   Publications      42  

11.3

   Prior Non-Disclosure Agreements      42  

11.4

   Equitable Relief      43  
Article XII    GENERAL PROVISIONS      43  

12.1

   Notices      43  

12.2

   Successors and Assigns      44  

12.3

   Entire Agreement; Severability      44  

12.4

   Export Control      45  

12.5

   Compliance with Applicable Laws      45  

12.6

   Performance by Affiliates      45  

12.7

   Further Actions      45  

12.8

   Amendments and Waivers      45  

12.9

   Third Person Beneficiaries      45  

12.10

   Expenses      46  

12.11

   Counterparts; Signatures      46  

12.12

   Attorneys’ Fees      46  

12.13

   Time is of the Essence      46  

12.14

   Specific Performance      46  

12.15

   Relationship of the Parties      46  

12.16

   Governing Law; Disputes      46  

12.17

   Waiver of Jury Trial      47  

12.18

   Independent Contractor      47  

 

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TABLE OF CONTENTS

(continued)

 

          Page
ANNEXES      
Annex I    Asset Purchase Agreement   
Annex II    Initial Development Plan   
Annex III    Patent Jurisdictions   
Annex IV    Option Package   
Annex V    Required Signing Third Party Consents   
Annex VI    Required Post-Signing Third Party Consents   
Annex VII    Development Funding Schedule   

 

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Confidential

Execution Version

COLLABORATION AND OPTION AGREEMENT

This COLLABORATION AND OPTION AGREEMENT (as may be amended in accordance with its terms, the “Agreement”), dated as of August 12, 2022 (the “Effective Date”), is made by and between Q32 BIO INC., a Delaware corporation (the “Company”), and HORIZON THERAPEUTICS IRELAND DAC, a company organized under the laws of Ireland (“Horizon”). Each of the Company and Horizon is referred to herein, individually, as a “Party” and, collectively, as the “Parties.”

RECITALS

A. The Company controls assets and rights for the development, manufacture and commercialization of Compounds (as defined below) for potential use in treating patients with severe inflammatory and autoimmune diseases;

B. Upon the terms and subject to the conditions contained herein, the Company will conduct development of Compounds for selected indications in accordance with a written development plan agreed to by the Company and Horizon;

C. Horizon desires to obtain from the Company, and the Company desires to grant to Horizon, an exclusive Option (defined below), exercisable on the terms and subject to the conditions set forth herein;

D. Concurrently with the execution and delivery of this Agreement, the Company and Horizon have entered into an asset purchase agreement, in the form attached as Annex I (as may be amended in accordance with its terms, the “Asset Purchase Agreement”), which provides for the acquisition by Horizon from the Company of all rights and assets related to, or necessary for the worldwide development, manufacture, use, registration, commercialization or other exploitation of, the Compounds and Products (defined below) (the “Asset Acquisition”), if Horizon exercises the Option, on the terms and subject to the conditions set forth in this Agreement and the Asset Purchase Agreement; and

E. The board of directors of the Company has approved and declared advisable this Agreement, the Option, the Asset Purchase Agreement and the Asset Acquisition and the other Contemplated Transactions.


Confidential

Execution Version

 

AGREEMENT

NOW, THEREFORE, in consideration of the mutual covenants and agreements hereinafter set forth, the Parties to this Agreement agree as follows:

ARTICLE I

DEFINITIONS

1.1 Definitions. In this Agreement, the following terms have the meanings specified or referred to in this Section 1.1 and shall be equally applicable to both the singular and plural forms.

“Abbreviated CSR” has the meaning specified in the Development Plan.

“Acquired Assets” has the meaning specified in the Asset Purchase Agreement.

“Acquired Business Contracts” has the meaning specified in the Asset Purchase Agreement.

“Acquiring Parties” has the meaning specified in Section 3.8(b).

“Acquisition Proposal” has the meaning specified in Section 8.5.

“Action” means any lawsuit, claim, hearing, enforcement, audit, investigation, lawsuit, action (including arbitration or mediation) or other regulatory, or judicial proceeding.

“Additional Excess Development Funding” has the meaning specified in Section 3.3(b).

“Affiliate” means, as to any Person, any other Person that, directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with that Person, but only for so long as such control exists. For purposes of this definition, “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”), as used with respect to any Person or group of Persons, means possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of the Person, whether (a) through direct or indirect beneficial ownership of at least 50% (or such lesser percentage which is the maximum allowed to be owned by a foreign entity in a particular jurisdiction) of the voting stock or other ownership interest in such corporation or other entity, or (b) by contract.

“Agreement” has the meaning set forth in the preamble of this Agreement.

“Alliance Manager” has the meaning specified in Section 2.7.

“Antibody” means any antibody or antigen binding fragment thereof (including any bispecific or multispecific antibody, single chain antibody or domain antibody) and/or similar antigen binding protein, whether polyclonal, monoclonal, human, humanized, chimeric, murine, synthetic or from any other source.

“Antitrust Laws” means the Sherman Act, as amended, the Clayton Act, as amended, the HSR Act, the Federal Trade Commission Act, as amended, state antitrust laws, and all other applicable Laws and regulations (including non-U.S. laws and regulations) issued by a Governmental Authority that are designed or intended to preserve or protect competition, prohibit and restrict agreements in restraint of trade or monopolization, attempted monopolization, restraints of trade and abuse of a dominant position, or to prevent acquisitions, mergers or other business combinations and similar transactions, the effect of which may be to lessen or impede competition or to tend to create or strengthen a dominant position or to create a monopoly.

“Asset Purchase Agreement” has the meaning set forth in the recitals of this Agreement.

“Asset Purchase Closing Notice” has the meaning specified in Section 4.4(b).

 

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Confidential

Execution Version

 

“Automatic Option Package Trigger” has the meaning specified in Section 3.7.

“BMS” has the meaning specified in Section 8.4(o).

“BMS License Agreement” has the meaning specified in Section 8.4(o).

“Breaching Party” has the meaning specified in Section 10.2(c).

“Business Day” means any day that is not a Saturday, a Sunday or other day on which banks are required or authorized by Law to be closed in Illinois, Ireland or Massachusetts.

“Certificate of Incorporation” means the certificate of incorporation of the Company, as currently in effect, and as amended from time to time.

“Chairperson” has the meaning specified in Section 2.1.

“Change in Control” means, with respect to a Party, (a) a merger, consolidation, reorganization, amalgamation, arrangement, share exchange, tender or exchange offer, private purchase, business combination or other transaction of such Party with a Third Party that results in the voting securities of such Party outstanding immediately prior thereto, or any securities into which such voting securities have been converted or exchanged, ceasing to represent more than 50% of the combined voting power of the surviving entity or the parent of the surviving entity immediately after such merger or consolidation, (b) a transaction or series of related transactions in which a Third Party, together with its Affiliates, becomes the direct or indirect beneficial owner of more than 50% of the combined voting power of the outstanding securities of such Party, provided that a sale of securities for bona fide fundraising purposes shall not be deemed a Change in Control for purposes of this Agreement, or (c) the sale or other transfer to a Third Party of all or substantially all of the assets of such Party and its direct and indirect subsidiaries.

“Claim Notice” has the meaning specified in Section 9.3(a).

“Clinical Trial” means any human clinical study of a pharmaceutical or biologic product.

“Clinical Trial Safety Concern Issue” has the meaning specified in Section 2.5(a).

“Closing” has the meaning specified in the Asset Purchase Agreement.

“Closing Date” has the meaning specified in the Asset Purchase Agreement.

“CMC” means chemistry, manufacturing, and controls.

“Code” means the Internal Revenue Code of 1986, as amended.

“Company” has the meaning specified in the preamble of this Agreement.

“Company Contract” has the meaning specified in Section 6.4(b).

“Company Contributors” means individuals conducting Development Program activities on behalf of the Company.

 

3


Confidential

Execution Version

 

“Company Delivery Period” has the meaning specified in Section 4.4(a).

“Company Disclosure Schedules” has the meaning specified in Article VI.

“Company Representatives” has the meaning specified in Section 11.1(a).

“Competitive Activities” means, except for activities conducted under this Agreement in accordance with the Development Plan, discovery, research, development or commercialization activities with respect to any Antibody that acts through, and is designed to specifically bind to and inhibit either [***] as its primary mechanism of action.

“Complete Final Data Set” has the meaning specified in the Development Plan.

“Compound” means the Lead Compound and all modifications, derivatives, fragments or variants thereof.

“Confidential Information” means any and all information, data or know-how (including Know-How), whether technical or non-technical, whether in oral, written, graphic, or electronic form, that is disclosed by one Party or its Affiliates (“Disclosing Party”) to the other Party or its Affiliates (“Receiving Party”), including any Confidential Information as defined in the Confidentiality Agreements disclosed by any Disclosing Party to a Receiving Party pursuant to the Confidentiality Agreements, prior to the Effective Date. Confidential Information shall not include any information, data or know-how that the Receiving Party can demonstrate by competent written proof:

(a) was generally available to the public at the time of disclosure, or information that becomes available to the public after disclosure by the Disclosing Party other than through any action or inaction of the Receiving Party;

(b) was already known to the Receiving Party prior to its receipt from the Disclosing Party;

(c) was disclosed to the Receiving Party on a non-confidential basis by a Third Party who, to the actual or constructive knowledge of the Receiving Party, had no obligation of confidentiality to the other Party; or

(d) is developed independently by the Receiving Party as evidenced by written records and without use or knowledge of Confidential Information.

The terms of this Agreement shall be considered Confidential Information of both Parties. Documents, materials and other information which the Receiving Party obtained from the Disclosing Party regarding the Disclosing Party during the course of the negotiations leading to the Contemplated Transactions (whether obtained before or after the Effective Date), the investigation provided for herein and the preparation of this Agreement, the Asset Purchase Agreement and other related documents shall be considered Confidential Information of the Disclosing Party.

“Confidentiality Agreements” means that certain [***] and the [***] as may be amended.

 

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“Consideration” has the meaning specified in the Asset Purchase Agreement.

“Contemplated Transactions” has the meaning set forth in Section 6.2.

“Contract” means any written or oral contract, or agreement, including supply contracts, licenses, binding commitments, customer agreements, subcontracts, leases of personal property, notes, guarantees, pledges, and conditional sales agreements to which the Person referred to is a Party or by which any of its assets are bound.

“Control” or “Controlled by” means, with respect to any Intellectual Property or asset, the possession by a Party of the ability (whether by ownership, license or other right) to grant access to, or a license or sublicense of, such Intellectual Property or asset without violating the terms of any agreement or other arrangement with any Third Party. Notwithstanding the foregoing, any Intellectual Property (including Patents) owned or licensed by a Third Party prior to the date that such Third Party becomes an Affiliate of a Party pursuant to Change in Control shall be excluded from the definition of rights “Controlled” by such Party and its Affiliates on and after the date of consummation of such transaction, except to the extent such Intellectual Property (a) was Controlled by such Party immediately prior to the consummation of such Change in Control or (b) is used by or on behalf of such Party or such Affiliate after the consummation of such Change in Control in the development, manufacture, use, commercialization or other exploitation of any Compound or Product in any country or jurisdiction.

“Deliverables” means the deliverables set forth in the Development Plan.

“Development Funding” has the meaning set forth in Section 5.2.

“Development Plan” means the written plan setting forth the development, regulatory, toxicology and manufacturing activities to be performed with respect to Compounds and Products, including the deliverables, budget (within the funding amounts set forth in this Agreement) and anticipated timelines for such activities, as such plan and budget may be updated from time to time in accordance with the terms of this Agreement, such Development Plan to be in accordance with the Company’s obligations to applicable Regulatory Authorities, ethics committees and/or institutional review boards as IND/CTA holder. The initial Development Plan is set forth on Annex II.

“Development Program” means all development, regulatory, toxicology and manufacturing activities with respect to Compounds and Products to be undertaken by or on behalf of the Company during the term of this Agreement, including all activities performed pursuant to the Development Plan.

“Effective Date” has the meaning specified in the Recitals.

“EMA” means the European Medicines Agency, or any successor agency thereto.

“Excess Development Funding” means direct costs incurred by the Company in the conduct of Development Program activities by or on behalf of the Company under the Development Plan that exceed $[***].

 

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“Executives” has the meaning specified in Section 2.5(a).

“Expert” has the meaning specified in Section 2.5(b).

“Expert Determination Notice” has the meaning specified in Section 2.5(b).

“FDA” means the U.S. Food and Drug Administration, or any successor agency thereto.

“Final CSR” has the meaning specified in the Development Plan.

“Futility Termination Date” has the meaning specified in Section 2.5(b).

“GAAP” means U.S. generally accepted accounting principles, consistently applied.

“GCP” means then-current good clinical practices, standards and procedures promulgated or endorsed by the FDA as set forth in the guidelines entitled “Guidance for Industry E6 Good Clinical Practice,” including related regulatory requirements imposed by the FDA, in 21 C.F.R parts 11, 16, 50, 54, 56, 58, 312, 324, 320, 511, 514, 601, 812, and 814, and comparable regulatory standards, practices and procedures promulgated by any other Regulatory Authority, including applicable quality guidelines promulgated under the ICH, in each case, as amended from time to time and applicable to relevant activities hereunder.

“GLP” means then-current good laboratory practices promulgated or endorsed by the FDA, as set forth in 21 C.F.R. Part 58, and comparable regulatory standards promulgated by any other Regulatory Authority, including applicable quality guidelines promulgated under the ICH, in each case, as amended from time to time and applicable to the relevant activities hereunder.

“GMP” means then-current good manufacturing practices and standards for the production of drugs and finished biologics promulgated or endorsed by the FDA, as set forth in 21 C.F.R. Parts 210, 211, 600 through 680, 820, and 1271, as applicable, and comparable regulatory standards promulgated by any other Regulatory Authority, including applicable guidelines promulgated under the ICH, in each case, as amended from time to time and applicable to the relevant activities hereunder.

“Governmental Authority” means any United States federal, state, local, or any non-U.S. government, governmental, regulatory or administrative authority, agency or commission or any court, tribunal, or judicial or arbitral body.

“Horizon” has the meaning specified in the first paragraph of this Agreement.

“Horizon Group Member” means (a) Horizon and its Affiliates, (b) the directors, officers, employees, agents, attorneys and consultants of each of Horizon and its Affiliates and (c) the respective successors and permitted assigns of each of the foregoing.

“Horizon Representatives” has the meaning specified in Section 11.1(a).

“HSR Act” shall mean the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.

 

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“ICH” means the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

“IND” means an investigational new drug application (including any amendment or supplement thereto) submitted to the FDA pursuant to 21 C.F.R. Part 312, or the comparable application submitted to the applicable Regulatory Authority, including any amendments or supplements thereto.

“Interest Withdrawal Notice” has the meaning specified in Section 4.4(c).

“Interest Withdrawal Period” has the meaning specified in Section 4.4(b).

“Indemnified Party” has the meaning specified in Section 9.3(a).

“Indemnitor” has the meaning specified in Section 9.3(a).

“Initial Excess Development Funding” has the meaning specified in Section 3.3(b).

“Initiation” means, when used with respect to a Clinical Trial, the randomization of the first patient for such Clinical Trial.

“Intellectual Property” means any and all of the following and any and all rights associated with the following, in any jurisdiction throughout the world, by whatever name or term known or designated, whether arising by operation of Law, Contract, or otherwise:

(a) Patents;

(b) trademarks, trade names, corporate names, service marks, brand names, generic names, logos, trade dress, slogans, and other indicia of source or origin together with all translations, adaptations, derivations, and combinations thereof and including all goodwill associated with the foregoing and all common-law rights thereto, as well as all applications, registrations and renewals in connection therewith;

(c) copyrights, mask work rights, moral rights, and common-law rights thereto, and all applications, registrations, and renewals in connection therewith throughout the world;

(d) domain names, uniform resource locators, other names and locators associated with the Internet, and applications or registrations for the foregoing;

(e) all rights in databases and data collections;

(f) all Know-How;

(g) all similar, corresponding, or equivalent rights to any of the foregoing anywhere in the world;

(h) all inventions and rights existing in any inventions; and

 

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(i) all rights to sue for past, present, or future infringement, violations, or misappropriation of any of the foregoing anywhere in the world.

“Invention” means an invention, including any improvement or modification, that is made during the term of this Agreement by one or more individuals conducting Development Program activities on behalf of the Company or any of its Affiliates.

“JSC” has the meaning specified in Section 2.1.

“Know-How” means data, knowledge, trade secrets, know-how, discoveries, inventions and technical, business or other proprietary information, including materials, samples, manufacturing data, chemistry, manufacturing, and controls information, toxicological data, pharmacological data, data from preclinical, clinical or non-clinical testing or studies, assays, processes, protocols, procedures, methods, devices, designs, results, technology, platforms, formulations, regulatory filings, applications, approvals and associated correspondence, specifications, quality control testing data, customer lists, mailing lists and business plans.

An individual shall be deemed to have “Knowledge” of a particular fact or other matter if (a) such individual is actually aware of such fact or other matter or (b) a prudent individual would be expected to discover or otherwise become aware of such fact or other matter in the course of conducting a reasonably diligent investigation, including reasonable inquiry with relevant employees and consultants, if any, who would reasonably be expected to have knowledge of the matters in question. The Company shall be deemed to have “Knowledge” of a particular fact or other matter if any executive officer of the Company, including the Chief Executive Officer, the Chief Financial Officer, the Chief Scientific Officer, the Chief Medical Officer, the Vice President of Clinical Development Operations and Senior Director, Global Manufacturing (or such individuals in similarly equivalent roles), has Knowledge of such fact or other matter.

“Later Imposed Withholding” has the meaning specified in Section 5.5.

“Laws” means any United States federal, state and local, and any non-U.S., laws, statutes, regulations, rules, codes or ordinances enacted, adopted, issued or promulgated by any Governmental Authority or common law, including GCP, GMP and GLP.

“Lead Compound” means the fully humanized, high affinity anti-interleukin-7 receptor α antagonist antibody known as ADX-914, as set forth on a schedule delivered to Horizon in connection with the execution and delivery of this Agreement on the Effective Date.

“Lien” means any lien, statutory lien, pledge, mortgage, security interest, claim, encumbrance, easement, right of way, option, conditional sale, or other title retention agreement of any kind or nature. In the case of Intellectual Property that is subject to any in-license or out- license, “Lien” includes the terms and conditions of such in-license or out-license, as applicable.

“Losses” means any damages, losses, expenses, costs, settlement payments, awards, judgments, fines or penalties, including reasonable attorneys’ fees (except as set forth in Section 12.12) and any amount payable as Taxes, but except to the extent incurred or paid in connection with a Third Party Claim, “Losses” shall not include unforeseeable, exemplary, punitive, speculative, or special damages.

 

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“Non-Breaching Party” has the meaning specified in Section 10.2(c).

“Notice of Intent” has the meaning specified in Section 4.1.

“Notice of Intent Date” has the meaning specified in Section 4.1.

“Option” has the meaning specified in Section 4.1.

“Option Exercise Date” has the meaning specified in Section 4.4(b).

“Option Exercise Notice” has the meaning specified in Section 4.4(b).

“Option Exercise Period” has the meaning specified in Section 4.1.

“Option Fee” has the meaning specified in Section 5.1.

“Option Package” has the meaning specified in Section 3.7.

“Option Package Delivery Date” has the meaning set forth in Section 3.7.

“Option Package Review Period” has the meaning set forth in Section 3.7.

“Option Package Trigger Date” has the meaning set forth in Section 3.7.

“Option Termination Date” means the date that is 45 days after the expiration of the Option Package Review Period.

“Order” means any writ, law, rule, regulation, executive order or decree, judgment, injunction, ruling, or other order, whether temporary, preliminary, or permanent enacted, issued, promulgated, enforced, or entered into by any Governmental Authority.

“Patents” means any and all (a) issued patents; (b) pending patent applications, including all priority patent applications, substitutions, continuations (in whole or in part), request for continued examination, divisions and renewals, and all patents granted thereon; (c) patents-of- addition, reissues, reexaminations, supplemental examinations and extensions or restorations by existing or future extension or restoration mechanisms, including patent term adjustments, patent term extensions, supplementary protection certificates or the equivalent thereof; (d) certificates of invention and applications for certificates of invention; (e) other forms of government-issued rights substantially similar to any of the foregoing; and (f) United States and foreign counterparts of any of the foregoing.

“Permitted Liens” means (a) landlords’, materialmen’s, mechanics’, carriers’, workmen’s, warehousemen’s, repairmen’s and other like Liens arising in the ordinary course of business or deposits to obtain the release of such Liens; (b) Liens for Taxes and other governmental charges and assessments which are not yet due and payable or are being contested in good faith; (c) purchase money or equipment Liens incurred in the ordinary course of business; and (d) other Liens or imperfections on property which do not adversely affect title to, detract from the value of, or impair the existing use of, the property affected by such Lien or imperfection.

 

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“Person” means any individual, corporation, partnership, joint venture, limited liability company, association, joint-stock company, trust, unincorporated organization or Governmental Authority.

“Phase 2 Clinical Trial” means a Clinical Trial of a Product, including a separate Clinical Trial or the second part of a fused “Phase 1/2” Clinical Trial, that is designed to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population.

“Phase 3 Clinical Trial” means a Clinical Trial of a Product, including a separate Clinical Trial or the second part of a fused “Phase 2/3” Clinical Trial, that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such pharmaceutical product in the dosage range and dose duration to be prescribed, which trial is intended to support Regulatory Approval of a Product.

“PMDA” means the Japanese Pharmaceuticals and Medical Devices Agency or its successor, or the Ministry of Health, Labour and Welfare.

“Post-Futility Action” has the meaning set forth in Section 2.5(b).

“Post-Futility Proceeds” means payments received by the Company from a Third Party in consideration for the transfer or license of rights to develop, commercialize or otherwise exploit any Compound or Product pursuant to a Post-Futility Action, including license fees, milestone payments, net sales revenue, and royalties, but specifically excluding (i) reimbursement of actual costs for research and development performed by the Company, (ii) reimbursement of actual costs for the manufacture or supply of Compounds or Products, and (iii) reimbursement of out-of-pocket patent expenses.

“Pre-Closing Period” has the meaning specified in Section 8.1(a).

“Pre-Existing Affiliate” has the meaning specified in Section 3.8(b).

“Pre-Existing Competitive Activities” has the meaning specified in Section 3.8(b).

“Proceeding” means any suit, claim, complaint, investigation, litigation, audit, proceeding, or arbitration by or before any Person.

“Product” means any product comprised of or containing a Compound, in any form or formulation.

“Program Technology” means the Intellectual Property Controlled by the Company or any of its Affiliates as of the Effective Date or during the Pre-Closing Period that is necessary or reasonably useful for the development, manufacture, use, commercialization or other exploitation of any Compound or Product in any country or jurisdiction.

“Proposed Publication” has the meaning specified in Section 11.2(b).

 

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“Prosecuted Patent” has the meaning specified in Section 3.6(b)(i).

“Publishing Notice” has the meaning specified in Section 11.2(b).

“Publishing Party” has the meaning specified in Section 11.2(b).

“Regulatory Approval” means all approvals from the relevant Regulatory Authority in a given country or regulatory jurisdiction that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale, or other commercialization of a product in such country or regulatory jurisdiction, including all licenses, registrations, and pricing or reimbursement approvals.

“Regulatory Authority” means any applicable Governmental Authority with jurisdiction or authority over the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale, or other commercialization of pharmaceutical or biologic products in a given country or regulatory jurisdiction, including the FDA in the United States.

“Regulatory Filings” means any and all regulatory applications, filings, approvals and associated correspondence required or related to the development, manufacture or commercialization of any Compound or Product in any country or jurisdiction.

“Requested Option Package Trigger” has the meaning specified in Section 3.7.

“Required Signing Third Party Consents” has the meaning specified in Section 4.3(c).

“Required Post-Signing Third Party Consents” has the meaning specified in Section 8.7.

“Schedule Delivery Date” has the meaning specified in Section 4.4(a).

“Step-In Activities” has the meaning specified in Section 3.9.

“Step-In Rights” has the meaning specified in Section 3.9.

“Specified Business” means the business of the Company and its Affiliates primarily related to the Acquired Assets, including the development, manufacture and commercialization of Compounds and Products.

“Tax” (and, with correlative meaning, “Taxes”) means any all federal, provincial, territorial, state, municipal, local, foreign or other taxes (including imposts, rates, levies, assessments, and other charges, in each case in the nature of a tax), including all income, excise, franchise, gains, capital, real property, goods and services, transfer, value added, gross receipts, windfall profits, severance, ad valorem, personal property, production, sales, use, license, stamp, documentary stamp, mortgage recording, employment, payroll, social security, unemployment, disability, estimated or withholding taxes, and all customs and import duties, together with all interest, penalties and additions to tax (and additional amounts imposed with respect to such amounts).

“Third Party” means any Person other than a Party hereto or an Affiliate of a Party hereto.

 

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“Third Party Claim” has the meaning specified in Section 9.3(a).

“Unanimous Matter” has the meaning specified in Section 2.5(b).

“Updated APA Schedules” has the meaning specified in Section 4.4(a).

“U.S.” or “United States” mean the United States of America and its territories and possessions.

“VAT” means value added tax, sales taxes, consumption taxes and other similar taxes imposed or required by applicable Law.

1.2 Interpretation. When a reference is made in this Agreement to an Article, Section, Schedule or Exhibit, such reference will be to an Article or Section of, or a Schedule or Exhibit to, this Agreement unless otherwise indicated. The table of contents and headings contained in this Agreement are for reference purposes only and will not affect in any way the meaning or interpretation of this Agreement. Whenever the words “include,” “includes” or “including” are used in this Agreement, they will be deemed to be followed by the words “without limitation.” The word “or” is used in the inclusive sense (and/or) unless the context dictates otherwise because the subjects of the conjunction are mutually exclusive. The words “hereof,” “herein” and “hereunder” and words of similar import when used in this Agreement will refer to this Agreement as a whole and not to any particular provision of this Agreement. All terms used herein with initial capital letters have the meanings ascribed to them herein. The definitions contained in this Agreement are applicable to the singular as well as the plural forms of such terms and to the masculine as well as to the feminine and neuter genders of such term. Any statute defined or referred to herein or in any agreement or instrument that is referred to herein means such statute as from time to time amended, including by succession of comparable successor statutes. References to a Person are also to its permitted successors and assigns. Unless otherwise indicated, all monetary amounts herein are in United States dollars.

ARTICLE II

GOVERNANCE; JOINT STEERING COMMITTEE

2.1 Joint Steering Committee Formation; Composition. Within [***] after the Effective Date, the Parties shall establish a Joint Steering Committee (the “JSC”) composed of three representatives of each of the Company and Horizon, each of whom shall have appropriate technical credentials, experience, knowledge, and authority within such Party’s organization. Each Party may change its representatives to the JSC from time to time in its sole discretion, effective upon written notice of such change to the other Party. The Company shall designate one of its JSC representatives as chairperson of the JSC (the “Chairperson”).

2.2 Responsibilities and Authority. The JSC’s overall responsibility shall be to encourage and facilitate ongoing cooperation and communication between the Parties regarding the Development Program and any other activities contemplated by this Agreement. Subject to the terms and conditions of this Agreement, the JSC shall have the authority to:

(a) Make decisions with respect to the following matters, which are deemed Unanimous Matters (as defined below) for purposes of this Agreement:

(i) review, discuss and approve any substantive changes or updates to the Development Plan, including the budget and timelines included in the Development Plan;

 

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(ii) review, discuss and approve the Company’s protocol, scope and design for any Clinical Trial of a Compound or Product contemplated by the Development Plan, and any material changes thereto;

(iii) review and approve (i) the engagement of Third Party subcontractors that are first engaged after the Effective Date to perform work related to the Development Program, or (ii) any new or additional work related to the Development Program, or in preparation for post-Development Program activities, to be performed by any Third Party subcontractor, in each case of clause (i) and (ii), in excess of $[***] in any calendar year or $[***] in the aggregate (for clarity, to the extent such amounts are related to the Development Program), including in each case of clause (i) and (ii), (A) any Third Party subcontractors responsible for process development, (B) any Third Party contract manufacturer of any Compound or Product (whether drug substance or drug product), including in preparation for Phase 3 Clinical Trials, or (C) any Third Party contract research organization that would manage any Clinical Trial of any Compound or Product;

(iv) to review and approve the acquisition or in-license by the Company of any Intellectual Property Controlled by a Third Party that is or would be reasonably likely to be necessary or reasonably useful for the exploitation of any Compound or Product; and

(v) periodically assess whether the Development Program is commercially reasonable, or scientifically or operationally viable, and determine whether the Development Program should be continued.

(b) Consider the following matters:

(i) review and discuss Development Program activities, and the results of such activities;

(ii) discuss progress reports and other information generated by the Company in performing the Development Program and request other information relating to the progress of the goals or performance of the Development Program;

(iii) review and discuss regulatory correspondences and ongoing regulatory strategy relating to any Compound or Product;

(iv) review and discuss CMC matters (including process development) relating to any Compound and Product;

(v) review and advise on filing, prosecution and maintenance strategy for Patents within the Program Technology, including any Patents arising in the Development Program; provided, that such filing, prosecution and maintenance shall be subject to the terms and conditions of the BMS License Agreement, as applicable;

 

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(vi) discuss and address scientific or technical issues arising in the course of the Development Program;

(vii) review on a monthly basis (which frequency can be changed by mutual agreement of the Parties) the status of the budget for the conduct of the Development Program, including actual costs incurred in performance of the Development Program as compared to the budget in the Development Plan, and the Company’s financial position;

(viii) encourage and facilitate cooperation and communication between the Parties with respect to the Development Program;

(ix) establish subcommittees, which will report to the JSC, as needed to further the purposes of this Agreement; and

(x) perform such other functions as are expressly delegated to it under this Agreement or as the Parties agree in writing.

2.3 Meetings; Minutes. The JSC shall meet, in person or by teleconference or videoteleconference, at least once per calendar quarter, or more often as unanimously agreed by the JSC members. The location of in-person JSC meetings will alternate between a location selected by the Company and a location selected by Horizon. Each Party shall be responsible for all of its own expenses of participating in JSC meetings. The Company and Horizon shall alternate responsibility for preparing definitive minutes of each JSC meeting. After each meeting, a JSC representative of the then-responsible Party shall circulate a draft of the minutes to all members of the JSC for comments within [***] after such meeting. Such minutes shall provide a description, in reasonable detail, of the discussions at the meeting and shall document all decisions and determinations made by the JSC at such meeting. The Parties shall promptly discuss any comments on such minutes and finalize the minutes no later than the date of the next JSC meeting, and a JSC representative of each Party shall sign any finalized minutes.

2.4 Subcommittees. The JSC shall promptly establish the following subcommittees, and may establish additional subcommittees to oversee particular projects or activities within the scope of authority of the JSC as it deems necessary or advisable: (a) a development subcommittee to perform data analysis, review and discuss the Company’s protocol, scope and design for any study or Clinical Trial, and to review and discuss other development and clinical matters, (b) an intellectual property subcommittee to oversee the filing, prosecution and maintenance strategy for Patents within the Program Technology, including any Patents arising in the Development Program, in accordance with Section 2.2(b)(v) and (c) a subcommittee to oversee CMC matters (including process development and manufacturing activities) relating to any Compound or Product as well as technology transfer matters. Each subcommittee shall consist of such number of members of each Party as the JSC determines is appropriate from time to time and shall meet at least once per month or with such other frequency as the JSC or the Parties shall determine. The subcommittees will make recommendations to the JSC, and will not have decision making authority unless expressly granted by the JSC. Any decision before a subcommittee shall require unanimous approval, including an affirmative vote of at least one representative of each Party. The Alliance Manager from each Party will attend each subcommittee meeting.

 

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2.5 Decision-Making; Dispute Resolution.

(a) Decisions of the JSC shall be made by unanimous vote, with the Company’s representatives on the JSC collectively having [***] and Horizon’s representatives on the JSC collectively having [***]. No vote of the JSC may be taken unless at least one of each Party’s representatives is present for the vote. Each Party shall be responsible for ensuring that, at all times, its representatives on the JSC act reasonably and in good faith in carrying out their respective responsibilities hereunder. If the JSC cannot reach consensus with regard to any matter within its authority within [***] ([***] for any issue to be addressed by the JSC under Section 2.2(a)(ii) with respect to the handling of a material safety concern that arises in a Clinical Trial under the Development Program (the “Clinical Trial Safety Concern Issue”)) after such matter has been brought to the JSC’s attention, then such matter shall be referred to the President and Chief Executive Officer of the Company and the Chief Strategy Officer of Horizon, or their designees (the “Executives”), who will promptly meet and attempt in good faith to resolve such issue [***] ([***] for any Clinical Trial Safety Concern Issue) from the date upon which such matter is referred to them, which resolution agreed to by the Executives shall be considered a decision made by the JSC.

(b) In the event that the Executives are unable to resolve such issue within 10 days of the issue being referred to them, then, subject to Section 2.6, (i) the JSC representatives of the Company shall have the tie-breaking vote of such matters, excluding the Unanimous Matters, and (ii) the unanimous vote of the JSC will be required for any matter set forth in Section 2.2(a) (any such matter described in this clause (ii), a “Unanimous Matter”); provided that (1) regarding any [***], (A) if the JSC and Executives are unable to resolve such issue pursuant to this Section 2.5, the Company shall have final decision-making authority with respect to any decision [***]; and (2) if, under Section 2.2(a)(v), the Company believes that the continuation of the Development Program would be scientifically or operationally non-viable, but Horizon does not agree with the Company’s assessment, and the JSC and Executives are unable to resolve such issue pursuant to this Section 2.5 within the time periods contemplated hereby, (A) either Party may elect by written notice to the other Party (an “Expert Determination Notice”) to have such matter resolved by an independent Third Party expert with appropriate scientific, technical and regulatory expertise regarding the research and development of pharmaceutical products who is not and has not been at any time within the previous five years an employee, consultant, officer or director of either Party (an “Expert”) who is mutually agreed to by the Parties (provided, that if the Parties cannot agree on a mutually acceptable Expert within [***] after an Expert Determination Notice, then within [***] after the expiration of such [***] period, each of Horizon and the Company shall appoint one Expert who shall jointly select a third Expert who shall serve as the “Expert” for purposes of this Section 2.5), with such Expert directed to decide such matter by selecting either the Company’s position or Horizon’s position, and such Expert’s decision shall be binding on both Parties, (B) the costs and expenses incurred for engaging such Expert shall be borne by the Party whose position such Expert’s decision is against, (C) except as otherwise mutually agreed by the Parties, in rendering his or her decision the Expert shall apply the Judicial Arbitration and Mediation Services (JAMS) Comprehensive Arbitration Rules and Procedures and the Final Offer (or Baseball) Arbitration rules set out in Section 33 thereof, or the equivalent successor rules in effect at the time such Dispute arises, subject to the provisions of this Section 2.5, (D) any proceedings conducted by the Expert shall take place in New York, New York, and (E) if such Expert agrees with the Company on such issue, Horizon shall have a period of 60 days following

 

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the date such Expert issues his or her opinion to deliver an Option Exercise Notice, and if Horizon has not delivered an Option Exercise Notice within such [***] period, then this Agreement shall automatically terminate following the expiration of such [***] period (the “Futility Termination Date”). In the event that this Agreement terminates pursuant to the preceding clause (E), and (x) the Company transfers or licenses for value to a Third Party the rights to develop, commercialize or otherwise exploit any Compound or Product (except (i) as part of a Change in Control (but this exclusion will not apply if the Compound or Product and related assets constitute substantially all of the assets of the Company other than cash or investments), (ii) in connection with the termination of the BMS License without the Company’s receipt of consideration to terminate the BMS License, or (iii) as reasonably required to enable an investigator-initiated trial in which the Company does not receive any consideration other than reimbursement of actual cost for supply of Compound or Product to be used for such trial), or (y) the Company (including any Affiliate or Third Party on its behalf) engages in substantive activities to develop, commercialize or otherwise exploit any Compound or Product, in each case of (x) and (y), within the [***] period following the Futility Termination Date (a “Post-Futility Action”), the Company shall reimburse Horizon for [***]% of the Development Funding paid by Horizon to the Company under this Agreement prior to the Futility Termination Date, within [***] following the first occurrence of any Post-Futility Action; provided that (A) in the event of a Post-Futility Action described in clause (x), the Company shall use no less than [***]% of the Post-Futility Proceeds received by the Company in such Post-Futility Action (within [***] of the receipt thereof) to reimburse Horizon for such Development Funding if such reimbursement has not otherwise been made, and (B) in the event of a Post-Futility Action described in clause (y), if development of the Compound or Product is limited to the [***] field, the Company shall only be obligated to reimburse Horizon out of any revenues of the Company (including any Affiliate or Third Party on its behalf) if and when received, without the obligation to reimburse Horizon within the aforementioned [***] period.

(c) Except as expressly set forth in this Section 2.5, if there is not a unanimous vote of the JSC to approve or determine any Unanimous Matter, then such matter shall not be approved or determined, unless otherwise subsequently agreed to by the Parties or the JSC. Subject to the foregoing decision-making and dispute resolution process for decisions of the JSC within the scope of its authority and compliance with the terms of this Agreement, the Asset Purchase Agreement and the Development Plan, the Company shall be responsible for and shall have final decision-making authority with respect to its day-to-day operations and the implementation of the activities under the Development Plan.

2.6 Limitation on Authority. The JSC shall have only such rights, powers and authority as are expressly delegated to it under this Agreement, and the JSC shall not be a substitute for the rights of the Parties hereunder. Notwithstanding any other provision of this Agreement to the contrary, the JSC shall not have any right, power or authority:

(a) to determine any issue in a manner that would conflict with the express terms and conditions of this Agreement;

(b) to require either Party to take any action or omit to take any action that a Party reasonably believes upon advice of counsel to be in violation of applicable Law; or

(c) to modify or amend the terms and conditions of this Agreement.

 

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2.7 Alliance Manager. Each Party shall appoint an individual to be the alliance manager within each Party (the “Alliance Manager”) with responsibility for facilitating communication between the Parties regarding the Development Program. The Alliance Manager of each Party may be a member of the JSC. If the Alliance Manager of each Party is not a JSC member, then the Alliance Manager may attend JSC meetings as a non-voting participant. The Alliance Manager shall facilitate resolution of potential and pending issues and potential disputes to enable the JSC to reach consensus and avert escalation of such issues or potential disputes. The Alliance Manager of each Party shall make reasonable efforts during normal business hours to meet with or otherwise address reasonable questions from the Alliance Manager of the other Party, if requested, in between the meetings of the JSC or any subcommittee established by the JSC and the reports provided under Section 3.5, regarding any matters under this Agreement.

ARTICLE III

DEVELOPMENT PROGRAM

3.1 Development Plan. The Company and Horizon have agreed to the initial Development Plan set forth on Annex II as of the Effective Date. After the Effective Date, updates to the Development Plan may be regularly proposed by the Company or Horizon, and any substantive changes or updates to the Development Plan shall be subject to review, discussion and approval by the JSC as set forth in Section 2.2(a)(i).

3.2 Performance of Development Program. The Company shall perform the Development Program in accordance with the Development Plan and all applicable Laws. The Company may perform some or all of the Development Program through its Affiliates or, subject to the JSC’s approval pursuant to Section 2.2(a)(iii), as applicable, one or more Third Party subcontractors. The Company shall remain responsible for the performance by any of its Affiliates or Third Party subcontractors and the compliance of its Affiliates or Third Party subcontractors with the provisions of this Agreement in connection with such performance. The Development Program shall commence on the Effective Date and shall continue until the end of the term of this Agreement.

3.3 Funding of Development Program.

(a) Responsibilities and Costs. Horizon will provide Development Funding for the Development Program as set forth in Section 5.2. The Company shall conduct or have conducted on its behalf, at its sole expense, all Development Program activities set forth in the Development Plan, including all clinical and regulatory activities and the manufacture and supply of Compounds and Products for use in performing the Development Program, in accordance with the Development Plan. The Company (a) shall use the Development Funding expressly for activities set forth in the Development Plan and for no purpose other than conducting the Development Plan and activities expressly contemplated by the Development Plan and (b) shall not use the Development Funding to cover any payments due to BMS under the BMS License Agreement, except for, in each case of (a) and (b), any Development Funding that remains unused on the Closing Date and is not required to pay for Development Program activities set forth in the Development Plan conducted prior to the Closing Date.

 

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(b) Excess Development Costs. In the event that Excess Development Funding is necessary for the Company to perform activities under the Development Plan, the Company shall fund the initial $[***] of Excess Development Funding (the “Initial Excess Development Funding”). In the event that Excess Development Funding above the Initial Excess Development Funding (any necessary Excess Development Funding above the Initial Excess Development Funding, the “Additional Excess Development Funding”) is necessary or is reasonably and in good faith expected by the Company to be necessary for the Company to perform activities under the Development Plan, the Company shall provide written notice of such requirement to Horizon, with details of the amount of Additional Excess Development Funding required for such activities and the reasons such funding is necessary. To the extent such Additional Excess Development Funding is necessary or is reasonably and in good faith expected by the Company to be necessary for the Company to perform activities under the Development Plan and is needed due to factors outside of the reasonable control of the Company, and provided that the Company has otherwise complied in all material respects with its obligations under this Agreement, Horizon will share equally on a [***] basis with the Company up to a total of $[***] of such Additional Excess Development Funding (i.e., Horizon will pay the Company up to $[***] for Horizon’s share of Additional Excess Development Funding), and will pay for its share of such Additional Excess Development Funding on a quarterly basis in arrears based on the Company’s invoices for the same. The Company shall fund any Additional Excess Development Funding that is needed due to factors within the reasonable control of the Company or above $[***] in Additional Excess Development Funding on its own; provided that, if Additional Excess Development Funding beyond $[***] is needed as a result of factors outside of the reasonable control of the Company, the Parties shall discuss in good faith the funding for such amounts, provided further that Horizon shall have no obligation to pay any portion of Additional Excess Development Funding beyond $[***] in Additional Excess Development Funding, regardless of whether Horizon exercises the Option and proceeds to the Closing, except if Horizon expressly agrees to do so in writing in its sole discretion.

3.4 Regulatory Responsibilities.

(a) Regulatory Filings. Prior to any submission of a substantive Regulatory Filing to the FDA, EMA, PMDA, or any other Regulatory Authority, the Company will provide a copy of such Regulatory Filing to Horizon with reasonably sufficient time for Horizon’s review and comment, will consider in good faith any reasonable comments timely made by Horizon with respect to such Regulatory Filing, and will implement such timely comments to the extent commercially reasonable.

(b) Interactions with Regulatory Authorities. The Company shall keep Horizon informed as to material interactions with Regulatory Authorities with respect to any Product. The Company shall notify Horizon within [***] of any request for a meeting or substantive conference with a Regulatory Authority regarding any Product, including with respect to an IND submission for any Product. To the extent not prohibited by applicable Law or the Regulatory Authority, Horizon shall have the right, but not the obligation, to have up to [***] Horizon representatives attend such meeting as non-participating observers. The Company will promptly furnish Horizon with copies of all substantive correspondence submitted to a Regulatory Authority or received from a Regulatory Authority with respect to any Product, including minutes from meetings with the Regulatory Authority.

 

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(c) Regulatory Inspection or Audit. If a Regulatory Authority notifies the Company that it plans to conduct an inspection or audit of the Company’s facility or a facility of any Affiliate or Third Party subcontractor with regard to any Product, the Company shall notify Horizon as soon as practicable after receipt of such notification of such audit or inspection and provide Horizon with copies of any materials provided to it by the applicable Regulatory Authority. In addition, if a Regulatory Authority conducts an unannounced inspection or audit of the Company’s facility or a facility of any Affiliate or Third Party subcontractor with regard to any Product, the Company shall notify Horizon as promptly as practicable of such audit or inspection. The Company shall cooperate, and shall cause the Affiliate or Third Party subcontractor to cooperate, with such Regulatory Authority during such inspection or audit. Following any such inspection or audit, (i) the Company will provide Horizon with a copy of any inspection or audit observations of such Regulatory Authority and copies of any other written communications received from Regulatory Authorities with respect to such facilities in a timely manner after its receipt thereof, and (ii) the Company will provide Horizon with a copy of any proposed written response to any such observations or communications with reasonably sufficient time for Horizon’s review and comment, will consider in good faith any reasonable comments timely made by Horizon with respect to such proposed response, and will implement such timely comments to the extent commercially reasonable.

3.5 Reports; Records; Audit.

(a) Progress Reports. The Company shall keep Horizon reasonably informed and updated regarding Development Program activities performed by it or on its behalf, and provide Horizon such other information required under the Development Plan relating to the progress of the goals or performance of the Development Program. In addition, at least [***] ([***] with respect to reports on Clinical Trial recruitment) during the term of this Agreement, the Company shall prepare and provide to Horizon a presentation of the progress of the work performed by the Company in the course of the Development Program during the preceding period ([***]) and actual and projected costs of conducting Development Program activities against the budget in the Development Plan, and in connection with delivery of the Option Package in accordance with Section 3.7, the Company shall provide to Horizon an update to the last presentation provided (such presentation may be accomplished through presentations to the JSC). Notwithstanding the foregoing, the Company shall promptly (and in any case within [***]) notify Horizon of any material development or update regarding development Program activities, including any material research and development, clinical, CMC, pharmacovigilance and intellectual property matters. Promptly following the delivery, if any, of the Asset Purchase Closing Notice by Horizon to the Company in accordance with Section 4.4, the Company shall provide to Horizon a final written report summarizing its activities under the Development Program and the results thereof to the extent not included in reports previously provided to Horizon. At the request of Horizon in connection with or following any such presentation or the final report, the Company and Horizon shall hold a meeting, either in person at a venue agreed by the Company and Horizon or by teleconference or videoconference, to discuss Horizon’s questions regarding such presentation or final report (such meeting may be accomplished through meetings of the JSC).

 

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(b) Records. The Company shall maintain (or cause to be maintained) records of the Development Program, including actual costs incurred in performance of the Development Program as compared to the budget in the Development Plan, in sufficient detail and in good scientific manner reasonably appropriate for patent, quality compliance, regulatory and financial tracking purposes. Such records will reflect all work done and results achieved by or on behalf the Company in performance of the Development Program and actual and planned use of the Development Funding. All laboratory notebooks shall be maintained for no less than the term of any Patents issuing therefrom, as applicable.

(c) Audit. Horizon shall have the right, at its own expense, to (i) cause an independent, certified public accounting firm reasonably acceptable to the Company to audit the Company’s records relating to costs incurred in performance of the Development Program to confirm compliance with this Agreement, (ii) to cause a quality compliance auditor reasonably acceptable to the Company to audit the Company’s records relating to performance of the Development Program (including CMC matters relating to any Compound or Product) to confirm compliance with regulatory and quality matters, and (iii) to have a representative located at the Company’s (or its contract manufacturer’s) manufacturing facilities to monitor CMC matters (including process development) relating to any Compound or Product; provided that in the case of a contract manufacturer under this clause (iii) such right is subject to such contract manufacturer’s agreement to allow such representative on site and such representative’s compliance with any requirements established by the contract manufacturer for on-site visitors; provided, further, that in the event that a contract manufacturer allows only one person as a visitor on site, the Company’s right to a monitor on site shall be primary and Horizon’s right shall be secondary. Each such audit right may only be exercised independently during normal business hours upon reasonable prior written notice to the Company, no more than [***] (for clarity, Horizon may exercise its audit right under each of clauses (i), (ii) and (iii) within the same [***]), except with respect to any “for cause” audit, which may be conducted more than [***] during any [***].

3.6 Intellectual Property.

(a) Ownership. Inventorship of Inventions shall be determined in accordance with U.S. patent laws. The Parties acknowledge and agree that the Company shall be responsible for conducting all Development Program activities in the Development Plan and that it is not intended that Horizon will perform any research or development activities relating to the Development Program. The Company shall own (and, for the avoidance of doubt, shall be treated as owning for U.S. federal and applicable state and local income Tax purposes) all Inventions, Know-How and Patents generated or made by or on behalf of the Company or any of its Affiliates in the course of conducting Development Program activities, including all such Inventions, KnowHow and Patents generated or made by Company Contributors. In the event that Horizon exercises its step-in rights specified in Section 3.9 and conducts research and development activities under the Development Plan or the Parties otherwise agree in writing that Horizon would conduct any such activities, Horizon will own any Know-How and Patents to be generated or made by or on behalf of Horizon, provided that prior to Horizon initiating any such activities the Parties will negotiate in good faith mutually agreeable terms and conditions with respect to (i) the Company granting Horizon such rights as are necessary for Horizon to conduct Development Program activities on behalf of the Company pursuant to the Development Plan and the terms of this Agreement, and (ii) Horizon granting the Company the non-exclusive rights to use any such KnowHow or Patents generated or made by or on behalf of Horizon pursuant to this Section 3.6(a) solely for the exploitation of the Compounds and Products; provided that such rights shall terminate upon Horizon’s exercise of the Option and consummation of the Closing, or termination of this Agreement pursuant to Section 10.2(a) or by Horizon pursuant to Section 10.2(c).

 

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(b) Prosecution and Maintenance.

(i) The Company shall, at its own expense and using counsel of its choice (which counsel shall be reasonably acceptable to Horizon), diligently prepare, file, prosecute, and defend in a national or regional patent office (including appeals, reissues, reexaminations, interferences, and derivation, post grant review (PGR), inter partes review (IPR) and opposition proceedings) and maintain (including appeals, reissues, re-examinations, interferences, and derivation, PGR, IPR and opposition proceedings) any and all (A) Patents owned by the Company and (B) Patents otherwise Controlled by the Company with respect to which the Company controls prosecution and maintenance, in each case of (A) and (B), within the Program Technology (each, a “Prosecuted Patent”). During the term of this Agreement, the Company shall furnish to Horizon copies of documents material to preparing, filing for, prosecuting and maintaining such Prosecuted Patents and implement any commercially reasonable comments timely made by Horizon regarding such matters, subject to the terms and conditions of the BMS License Agreement. The Company agrees to use commercially reasonable efforts to pursue additional patentable Inventions ([***]), and the Company agrees to consult with Horizon prior to filing patent applications to protect any such Inventions and implement any commercially reasonable comments timely made by Horizon regarding such matters. The Company agrees to use commercially reasonable efforts to file, prosecute and maintain Prosecuted Patents and patent applications filed by or on behalf of the Company on any patentable Inventions in at least the countries and jurisdictions listed in Annex III.

(ii) If, during the Pre-Closing Period, the Company decides not to prosecute and maintain any Prosecuted Patent (or not to pursue filing a patent application on any patentable Invention), or intends to allow such Prosecuted Patent to lapse or become abandoned without having first filed a substitute patent application covering the subject matter of such Prosecuted Patent that is actively prosecuted, it shall notify and consult with Horizon of such decision or intention at least [***] prior to the date upon which the subject matter of such Prosecuted Patent shall lapse or become abandoned, or in the case of a decision not to file on a patentable Invention, at least [***] prior to the date that Company intends to publicly disclose the subject matter of such patentable Invention. Subject to the rights of any owner or licensor of such Prosecuted Patent in the case of any in-licensed Patents or Patents to which the Company has an option to obtain a license and the terms and conditions of the BMS License Agreement, Horizon shall thereupon have the right (but not the obligation) to assume the prosecution and maintenance thereof at Horizon’s own expense with counsel of its choice in the name of the owner of such Patents.

(iii) Each Party agrees to cooperate fully in the prosecution and maintenance of Prosecuted Patents under this Section 3.6(b) and in the obtaining and maintenance of any patent extensions, supplementary protection certificates and the like with respect thereto respectively at its own costs.

 

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(c) Enforcement. Subject to the terms and conditions of any in-license agreements for Program Technology, including the BMS License Agreement:

(i) Each Party shall inform the other Party promptly if it becomes aware of any infringement or potential infringement of any Program Technology by a Third Party, and the Parties shall consult with each other to decide the best way to respond to such infringement.

(ii) The Company shall use commercially reasonable efforts to take action with respect to any Third Party infringements of any Program Technology. The Company agrees to keep Horizon reasonably informed of the progress with respect to such action and consider in good faith any timely suggestions by Horizon regarding such matters. The Company shall not, without the prior written consent of Horizon, enter into any compromise or settlement relating to such proceedings that (A) admits the invalidity or unenforceability of any Program Technology or (B) admits any wrongdoing by, or result in injunctive or other relief being imposed against Horizon.

(iii) If the Company decides not to act against a Third Party infringement of any Program Technology, subject to the rights of any owner of such Program Technology in the case of any in-licensed Program Technology or Program Technology to which the Company has an option to obtain a license, it shall notify Horizon in writing and Horizon may take such actions at its own cost and expense. Horizon shall not, without the prior written consent of the Company, enter into any compromise or settlement relating to such proceedings that (A) admits the invalidity or unenforceability of any Program Technology or (B) admits any wrongdoing by, or result in injunctive or other relief being imposed against the Company.

3.7 Preparation and Delivery of Option Package. The Company shall prepare and deliver to the JSC and Horizon a package of all of the data, information and other items listed on Annex IV to the extent not previously delivered or made available to Horizon (the “Option Package”) within [***] following the earlier of (a) the date of delivery of the second Complete Final Data Set (from the latter of the two completed Phase 2 Clinical Trials described in the Development Plan) (the “Automatic Option Package Trigger”), or (b) the date of the Company’s receipt of Horizon’s written notice requesting delivery of the Option Package, if Horizon elects to deliver such notice (the “Requested Option Package Trigger,” and the earlier of the date in clause (a) or (b), the “Option Package Trigger Date”). The date the Company delivers the Option Package to Horizon is referred to as the “Option Package Delivery Date”. Horizon shall have the opportunity to review and inspect the Option Package, and, when delivered, the Abbreviated CSRs from both Phase 2 Clinical Trials described in the Development Plan, if not included in the initial Option Package delivered to Horizon, from the Option Package Delivery Date (i) in the event the Option Package was delivered as a result of the Automatic Option Package Trigger, until the later of (A) the [***] following the Automatic Option Package Trigger, or (B) the [***] following the Company’s delivery of the second of the two Abbreviated CSRs to Horizon, or (ii) in the event the Option Package was delivered as a result of the Requested Option Package Trigger, until [***] after delivery of the Abbreviated CSR to Horizon (such period in clause (i) or (ii), as applicable, the “Option Package Review Period”). During the Option Package Review Period, Horizon may reasonably request from the Company and the Company shall provide (during the Option Package Review Period) to Horizon any such additional information that (1) is missing from the Option Package or (2) is either reasonably available to the Company or can be prepared expediently

 

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without unreasonable cost or disruption to the normal operations of the Company in order to enable Horizon to review and inspect the Option Package. In the event that the Company is required to deliver missing or additional information to Horizon in accordance with clause (1) or (2), the Option Package Review Period will be extended for an additional [***] period (or such longer period, up to [***], as reasonably requested by Horizon to accommodate its reasonable review) following the Company’s delivery of such missing or additional information to allow Horizon sufficient time to review such materials. Horizon may, in its sole and absolute discretion, exercise the Option pursuant to Section 4.1 and Section 4.4. In addition, the Company shall deliver the second of the two Final CSRs to Horizon prior to [***] after the initiation of the Interest Withdrawal Period, otherwise the Interest Withdrawal Period shall be extended until [***] after the Company’s delivery of the second of the two Final CSRs to Horizon. For clarity, regardless of the timing of the Option Package Trigger Date, the Company shall provide to Horizon the Abbreviated CSR, the Final CSR to the extent the Parties have not otherwise agreed in writing that Horizon would be responsible for generation of the Final CSR, and, except in the event that the Option Package was delivered as a result of the Requested Option Package Trigger, any other Deliverables (to the extent not previously delivered to Horizon), in each case as set forth in the Development Plan and in accordance with the anticipated timeline provided therein.

3.8 Exclusivity.

(a) During the term of this Agreement, the Company will not conduct, participate in, or fund (directly or indirectly), alone or with an Affiliate or Third Party, any Competitive Activities; provided, that the foregoing will not limit or prohibit the Company from entering into scientific consulting arrangements, in-license agreements and similar arrangements with Third Parties relating to development activities conducted in accordance with the Development Plan and subject, as applicable, to Section 2.2.

(b) In the event of a Change in Control of the Company, the exclusivity restrictions set forth in Section 3.8(a) shall not apply to any Competitive Activities of the Third Party that is the acquirer in such Change in Control or Affiliates of such Third Party (other than the Company and its Preexisting Affiliates) (collectively, the “Acquiring Parties”) that exist prior to the closing of such Change in Control (“Pre-Existing Competitive Activities”), provided, that (i) no Program Technology is used by or on behalf of the Company, its Preexisting Affiliates or the Acquiring Parties in connection with Pre-Existing Competing Activities, (ii) no Program Technology or other Confidential Information of the Company or its Preexisting Affiliates can be accessed by personnel of such Acquiring Parties involved in performing any Pre-Existing Competitive Activities, and (iii) such Acquiring Parties institute sufficient technical and administrative safeguards to ensure the requirements set forth in the foregoing clauses (i) and (ii) are met, including by creating “firewalls” between the personnel teams charged with working on any Pre-Existing Competitive Activities and any personnel teams charged with working on the activities under the Development Plan. “Preexisting Affiliate” means, with respect to the Company, any Affiliate of the Company or the Acquiring Party following such Change in Control that was an Affiliate of the Company prior to such Change in Control.

 

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(c) During the term of this Agreement, if Horizon conducts, participates in, or funds (directly or indirectly), alone or with an Affiliate or Third Party, any Competitive Activities, except as contemplated by this Agreement, Horizon shall (i) provide the Company with prompt written notice that Horizon is directly conducting or participating in such Competitive Activities; (ii) not allow the use of any Program Technology by or on behalf of Horizon or such Affiliate or Third Party in connection with such Competitive Activities, (iii) not allow Program Technology or other Confidential Information of the Company or its Preexisting Affiliates to be accessed by personnel of Horizon or such Affiliate or Third Party involved in performing such Competitive Activities, and (iv) cause the institution by Horizon or such Affiliate or Third Party of sufficient technical and administrative safeguards to ensure the requirements set forth in the foregoing clauses (ii) and (iii) are met, including by creating “firewalls” between the personnel teams charged with working on any such Competitive Activities and any Horizon personnel teams with access to Confidential Information regarding activities under the Development Plan.

3.9 Step-In Rights. If the Company materially breaches an obligation to perform the activities under the Development Plan, and fails to cure such material breach within [***] after written notice from Horizon requesting cure of such breach, then, without precluding Horizon’s rights to pursue all rights and remedies it may have under this Agreement, Horizon shall have the right, to the extent permitted under applicable Law, the BMS License Agreement, and any other applicable Contract to which the Company or any of its Affiliates is a party (the “Step-In Rights”), but not the obligation, to assume responsibility for performing or having performed any remaining activities under the Development Plan, but excluding any activities that would require granting Horizon a sublicense under the BMS License Agreement (collectively, the “Step-In Activities”). If Horizon exercises the Step-In Rights, the Company shall reasonably cooperate with Horizon to ensure that the Step-In Activities can be performed. Horizon shall have the right to offset any direct costs and expenses incurred by Horizon in conducting any Step-In Activities against the Consideration due to the Company, if Horizon exercises the Option pursuant to Article IV.

ARTICLE IV

OPTION; DELIVERIES

4.1 Grant of Option. The Company hereby grants to Horizon the exclusive, irrevocable option, but not the obligation, to acquire the Acquired Assets on the terms and subject to the conditions set forth in this Agreement and in the Asset Purchase Agreement (the “Option”), which Option is exercisable any time beginning on the Effective Date and ending at [***] Central Time on the Option Termination Date (the “Option Exercise Period”). At any time during the Option Exercise Period, Horizon may, in its sole and absolute discretion, deliver to the Company written notice of Horizon’s conditional intent (the “Notice of Intent”) to exercise the Option (the date of delivery of such notice, the “Notice of Intent Date”), and Section 4.4 shall apply. If Horizon exercises the Option prior to the earlier of (a) execution of a definitive agreement for a Change in Control of the Company or (b) the Company’s receipt of all Development Funding (except as stated in the next sentence), then, as a condition to the exercise of the Option, Horizon will agree to pay to the Company any Development Funding that has not been paid by Horizon prior to the Closing in accordance with the Asset Purchase Agreement. If Horizon exercises the Option after execution by the Company of a definitive agreement for a Change in Control, then Horizon will not be obligated to pay any unpaid Development Funding, if, and solely if, the Change in Control contemplated by such definitive agreement is consummated; provided that, for clarity, Horizon will not be obligated to pay any unpaid Development Funding until and unless such definitive agreement for the Change of Control is terminated without consummation of the Change of Control. The Parties acknowledge and agree that the Option shall be treated as an option for U.S. federal and applicable state and local income Tax purposes, and Horizon shall not be treated as having acquired the Acquired Assets for U.S. federal and applicable state and local income Tax purposes prior to the exercise of the Option in accordance with Section 4.4.

 

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4.2 Horizon’s Deliveries. Concurrently with the execution and delivery of this Agreement, Horizon is delivering to the Company the Asset Purchase Agreement, duly executed by Horizon.

4.3 The Company’s Deliveries. Concurrently with the execution and delivery of this Agreement, the Company is delivering to Horizon all of the following:

(a) a copy of (i) the Certificate of Incorporation and (ii) good standing, each as certified as of a recent date by the Secretary of the State of Delaware;

(b) a certificate signed by the Secretary of the Company and dated as of the Effective Date, in form and substance reasonably satisfactory to Horizon: (i) certifying the effectiveness, accuracy and completeness of the copies attached to such certificate of resolutions duly adopted by the Company’s board of directors authorizing the execution and delivery of this Agreement and the Asset Purchase Agreement by the Company, and the performance by the Company of its respective obligations hereunder and thereunder and the consummation of the Contemplated Transactions, and (ii) certifying the effectiveness, accuracy and completeness of action by written consent attached to such certificate pursuant to which stockholders of the Company holding the requisite number of shares of capital stock required to approve the sale of assets under the Asset Purchase Agreement pursuant to the Certificate of Incorporation and bylaws of the Company adopted this Agreement and the Asset Purchase Agreement and approved the Option, the Asset Acquisition and the other Contemplated Transactions;

(c) the consents, waivers or approvals set forth on Annex V (the “Required Signing Third Party Consents”); and

(d) the Asset Purchase Agreement, duly executed by the Company.

4.4 Option Exercise.

(a) Within [***] (which period of time may be automatically extended by the Company for one additional [***] period upon the Company’s written notice to Horizon) following the Notice of Intent Date or such later date as mutually agreed in writing by Horizon and the Company (the “Company Delivery Period”), the Company shall prepare and deliver to Horizon, dated the date of its delivery (the “Schedule Delivery Date”), a true, correct and complete updated schedule of assets (including a schedule of all Contracts proposed to be assigned to Horizon under the Asset Purchase Agreement) and disclosures and exceptions to the representations and warranties to be made by the Company pursuant to the Asset Purchase Agreement (which shall be arranged in sections and subsections corresponding to the numbered and lettered sections and subsections contained in the Asset Purchase Agreement) (the “Updated APA Schedules”), as if such representations and warranties were made as of the Schedule Delivery Date.

 

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(b) Subject to Section 4.4(d), Horizon shall have the right at any time before [***] Central Time on the date that is [***] following the Schedule Delivery Date, subject to extension as specified in this Section (such date, the “Interest Withdrawal Period”), to elect, in its sole discretion, to cause the Company and Horizon to consummate the Asset Acquisition by delivery to the Company of a written notice of such election (the “Option Exercise Notice”) to the Company of the exercise of the Option (the date of delivery of such notice, the “Option Exercise Date”). If the Interest Withdrawal Period does not expire before the Option Termination Date, the Option Termination Date shall be extended until the last day of the Interest Withdrawal Period.

(c) If the Company delivers the Updated APA Schedules pursuant to Section 4.4(a), at any time prior to the end of the Interest Withdrawal Period, Horizon may at its sole option deliver a written notice (the “Interest Withdrawal Notice”) to the Company stating that Horizon withdraws its Notice of Intent, and, upon delivery of the Interest Withdrawal Notice the Option shall be deemed not to have been exercised by Horizon and the Option shall remain in full force and effect until [***] Central Time on the Option Termination Date; provided that Horizon shall not be entitled to deliver more than two Interest Withdrawal Notices and provided further that the delivery of an Interest Withdrawal Notice shall not extend the Option Termination Date. If the Company delivers the Updated APA Schedules pursuant to Section 4.4(a), and if Horizon does not deliver an Option Exercise Notice by the last day of the Interest Withdrawal Period, the Notice of Intent will be deemed withdrawn at [***] Central Time on the last day of the Interest Withdrawal Period and the Option shall remain in full force and effect until [***] Central Time on the Option Termination Date, unless Horizon delivers a notice of termination of this Agreement pursuant to Section 10.2(b)(iii) concurrently with the delivery or deemed delivery of the Interest Withdrawal Notice. Horizon shall have the right to automatically extend the Interest Withdrawal Period up to [***] following written notice to the Company that Horizon, in good faith, has learned new information that raises a material concern regarding the Specified Business or the Development Program. Horizon’s delivery of a written notice to temporarily withdraw its Notice of Intent pursuant to Section 4.4(d)(i) shall not constitute an Interest Withdrawal Notice for purposes of this Section 4.4(c).

(d) Without limiting Horizon’s remedies hereunder, if the Company does not deliver the Updated APA Schedules to Horizon prior to the expiration of the Company Delivery Period, Horizon may, at its sole option;

(i) elect to temporarily withdraw its Notice of Intent by delivering written notice thereof to the Company during the [***] period following the end of the Company Delivery Period, and upon delivery of such notice the Option shall be deemed not to have been exercised by Horizon and each of the Option, the Option Termination Date and the Interest Withdrawal Period shall be extended by the number of days elapsed from the expiration of the Company Delivery Period until the date the Company delivers to Horizon the Updated APA Schedules; or

(ii) deliver an Option Exercise Notice, in which case, the Company Disclosure Schedules delivered on the Effective Date shall be deemed to be the Updated APA Schedules as of the Option Exercise Date for all purposes of this Agreement and the Asset Purchase Agreement, and all references to the Updated APA Schedules herein shall be deemed to refer to such Company Disclosure Schedules.

 

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(e) At or prior to the Closing, the Company and Horizon, as applicable, shall execute and deliver such other agreements, documents, instruments and certificates as are contemplated by the Asset Purchase Agreement to be executed and delivered by such Party concurrently therewith.

ARTICLE V

FINANCIAL TERMS

5.1 Option Fee. Within 15 days after the Effective Date, Horizon shall pay the Company $15,000,000 in immediately available funds to a bank account designed by the Company in writing in consideration for the Option (the “Option Fee”).

5.2 Development Funding. Horizon shall pay the Company $40,000,000 as funding of the Development Program in accordance with the Development Plan (the “Development Funding”) as provided in the schedule as Annex VII. If Horizon exercises the Step-In Rights pursuant to Section 3.9, Horizon shall have no obligation to pay the Company any Development Funding that was scheduled pursuant to this Section 5.2 to become payable after the effective date of Horizon’s exercise of the Step-In Rights. In the event Horizon delivers the Notice of Intent pursuant to Section 4.1 and has not withdrawn such notice pursuant to Section 4.4, any Development Funding that has not been paid by Horizon to the Company prior to such delivery of the Notice of Intent shall be added to the amount of the Closing Payment; except if the Company has executed a definitive agreement for a Change in Control of the Company before such delivery of the Notice of Intent, in which case Horizon shall not be responsible for any Development Funding that has not been paid by Horizon to the Company if, and solely if, the Company consummates the Change in Control contemplated by such definitive agreement; provided that, for clarity, Horizon will not be obligated to pay any unpaid Development Funding until and unless such definitive agreement for the Change of Control is terminated without consummation of the Change of Control. For U.S. federal and applicable state and local income Tax purposes, the Parties acknowledge and agree that the Development Funding is intended to be treated as payment for services provided by the Company pursuant to the Development Plan.

5.3 VAT on Payments. All payments due under this Agreement are exclusive of VAT. If any VAT is chargeable in respect of amounts payable pursuant to this Agreement, VAT shall be charged at the applicable rate required by applicable Law and the party making such payment shall pay the VAT amount on receipt of a VAT invoice in the appropriate form.

5.4 Withholding Tax; Cooperation. The Parties agree to cooperate with one another and use reasonable efforts to reduce or eliminate Tax withholding or similar obligations in respect of payments made by Horizon to the Company under this Agreement. To the extent Horizon is required under the Code, or any other Tax Laws to deduct and withhold Taxes on any payment to the Company, Horizon shall pay the amounts of such Taxes to the proper Governmental Authority in a timely manner and promptly transmit to the Company an official Tax certificate or other reasonable evidence of such withholding. If any Taxes are so deducted or withheld, such deducted or withheld amounts shall be treated for all purposes of this Agreement as having been paid to the Company. Upon Horizon’s reasonable request, the Company shall provide Horizon any Tax forms (including a United States Tax “residency certificate”, Internal Revenue Service Form W-8BEN or W-8ECI or other applicable Internal Revenue Service Form) that may be reasonably necessary

 

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in order for Horizon to determine whether to withhold Tax on any such payments or to withhold Tax on any such payments at a reduced rate under the Code or any other Tax Laws, including any applicable bilateral income Tax treaty. Horizon shall give reasonable support so that any withholding Tax or VAT may be minimized or avoided to the extent permitted under the applicable Laws and treaties. Each Party shall provide the other with reasonable assistance to enable the recovery, as permitted by applicable Laws, of withholding Taxes, VAT, or similar obligations resulting from payments made under this Agreement, such recovery to be for the benefit of the Party bearing such withholding Tax or VAT.

5.5 Later Imposed Withholding. In the event that Horizon does not withhold Taxes from a payment to the Company under this Agreement, and a Governmental Authority asserts that such payment was subject to withholding Taxes, the Company agrees to indemnify Horizon for any withholding Taxes imposed on Horizon with respect to such payments (the “Later Imposed Withholding”). At Horizon’s election, (a) Horizon may offset the amount of such Later Imposed Withholding from future payments due to the Company under this Agreement or the Asset Purchase Agreement, or (b) the Company shall pay the amount of such Later Imposed Withholding to Horizon promptly upon request. Promptly following Horizon withholding any Later Imposed Withholding or the Company remitting any Later Imposed Withholding to Horizon, Horizon will (i) pay to the relevant Governmental Authority the amount of such Later Imposed Withholding; and (ii) provide evidence of such payment to the Company on a reasonable and timely basis.

ARTICLE VI

REPRESENTATIONS AND WARRANTIES OF THE COMPANY

The disclosure schedule of the Company (the “Company Disclosure Schedules”) shall be arranged in sections and subsections corresponding to the numbered and lettered sections and subsections contained in this Article VI. As an inducement to Horizon to enter into this Agreement and to consummate the Contemplated Transactions, except as set forth in the Company Disclosure Schedules, the Company hereby represents and warrants to Horizon on the Effective Date, as follows:

6.1 Due Organization. The Company is a corporation, duly organized, validly existing and in good standing under the laws of the State of Delaware, with full power and authority to own, lease and operate its business and properties and to carry on its business as and where such properties and assets are now owned or leased and such business is now conducted. The Company is duly qualified, authorized, registered or licensed to do business and is in good standing under the laws of each jurisdiction in which either the ownership or use of the properties owned or used by it, or the nature of the activities conducted by it, requires such qualification, authorization, registration or licensure.

6.2 Authority; Binding Nature of Agreement. The Company has the requisite corporate power and authority to enter into and to perform its obligations under this Agreement and the execution and delivery of this Agreement and the performance by the Company of its obligations hereunder, and the consummation of the transactions contemplated hereby (the “Contemplated Transactions”), have been duly authorized by all necessary action on the part of the Company and its stockholders. This Agreement has been duly executed and delivered by the Company, and, assuming the due authorization, execution and delivery of this Agreement by

 

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Horizon, this Agreement constitutes the legal, valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, subject to any applicable bankruptcy, insolvency, reorganization, moratorium or similar laws now or hereinafter in effect relating to creditors’ rights generally or to general principles of equity.

6.3 No Conflict, Consents. Neither the execution and delivery by the Company of this Agreement and the Asset Purchase Agreement, nor the consummation by the Company of the Contemplated Transactions, conflicts with or results in a breach of any provisions of the Certificate of Incorporation or bylaws of the Company. Neither the execution, delivery or performance by the Company of this Agreement or the Asset Purchase Agreement, nor the consummation by the Company of the Contemplated Transactions will: (a) result in the creation or imposition of any Lien on any Acquired Asset; (b) subject to the receipt of those consents, waivers, approvals, authorizations or notices referred to in Section 6.4(b), require the consent of any Person (including to maintain in full force and effect any Company Contract as a result of the Contemplated Transactions), violate or conflict with, or result in a breach of, any provision of, or constitute a default under (or, with notice or lapse of time or both, would constitute a default under) or give rise to any right of any Person other than the Company of termination or cancellation, change of control rights of any Person other than the Company, a modification adverse to the Company, a notification required to be made by the Company, an enhancement of rights of any other Person, a revocation of a grant to the Company of rights or assets, a placement into or release from escrow of any assets of the Company or acceleration of any obligation of the Company or a loss of any benefit to which the Company is entitled, in each case under any of the terms, conditions or provisions of any Company Contract; or (c) subject to the receipt, taking, or making of those consents, approvals, permits, authorization, waivers, actions, filings or notification referred to in Section 6.4(a), violate or conflict with any Law or Order applicable to the Company or to which the assets of the Company are subject or bound.

6.4 Consents and Approvals.

(a) There are no consents, approvals, permits, authorizations, waivers or other actions by, or filings with or notifications to, any Governmental Authority that are required to be obtained or made by the Company in connection with the execution, delivery and performance by the Company of this Agreement or the Asset Purchase Agreement or the performance of the Company’s obligations hereunder or thereunder, other than as required by the HSR Act, if applicable, and any applicable filing, notification or approval in any foreign jurisdiction required by Antitrust Laws.

(b) Part 6.4(b) of the Company Disclosure Schedules sets forth a complete and accurate list of all consents, waivers, approvals, or authorizations of, or notices to, any Person (other than a Governmental Authority) that are required to be obtained or made by the Company under any Contract to which the Company is a Party or by which the Company or any of the assets of the Company are subject or bound (any such Contract, a “Company Contract”) in connection with the execution and delivery by the Company of this Agreement or the Asset Purchase Agreement or the performance of the Company’s obligations hereunder or thereunder. To the Knowledge of the Company, no condition or fact exists that would have the effect of preventing the Company from timely obtaining the Required Post-Signing Third Party Consents.

 

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6.5 Title to Assets. The Company and its Affiliates have, and at the Closing, the Company will deliver to Horizon, good, marketable and valid title to the Acquired Assets, free and clear of any Liens (other than Permitted Liens). The Acquired Assets include all of the tangible and intangible assets, properties and rights, of any nature whatsoever, that are necessary to conduct the Specified Business as presently conducted, except the Acquired Assets do not include (a) a facility or any infrastructure, including equipment, software, or telecommunications or operating infrastructure, such as compliance, pharmacovigilance, quality, regulatory, legal, finance, technical operations, human resources and back-office commercial operations necessary to operate the Specified Business, (b) working capital or (c) insurance. The Company has not received notice in writing or, to the Knowledge of the Company, no Person has asserted a claim of ownership or right of possession or use in and to any of the Specified Business or the Acquired Assets, other than Permitted Liens.

6.6 No Proceedings. There are no Proceedings pending, or to the Knowledge of the Company, threatened against or affecting the Company which has or might be reasonably expected to materially affect the Company’s ability to perform any of its obligations under this Agreement or the consummation of the Contemplated Transactions.

6.7 No Other Representations or Warranties. EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT AND THE ASSET PURCHASE AGREEMENT, THE COMPANY EXPRESSLY DISCLAIMS (AND HORIZON ACKNOWLEDGES AND AGREES) ANY REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR USE, NON-INFRINGEMENT, VALIDITY AND ENFORCEABILITY OF PATENTS, OR THE PROSPECTS OR LIKELIHOOD OF DEVELOPMENT OR COMMERCIAL SUCCESS OF COMPOUNDS OR PRODUCTS.

ARTICLE VII

REPRESENTATIONS AND WARRANTIES OF HORIZON

As an inducement to the Company to enter into this Agreement and to consummate the Contemplated Transactions, Horizon hereby represents and warrants to the Company on the Effective Date as follows:

7.1 Organization and Authority.

(a) Horizon is a designated activity company duly organized, validly existing and in good standing under the laws of Ireland. Horizon has the requisite corporate power and authority to enter into and perform its obligations under this Agreement and the Asset Purchase Agreement, and the execution and delivery and performance by Horizon hereunder and thereunder has been duly authorized by all necessary corporate action on the part of Horizon.

(b) Each of this Agreement and the Asset Purchase Agreement have been duly executed and delivered by the Horizon and, assuming the due authorization, execution and delivery of this Agreement and the Asset Purchase Agreement by the Company, this Agreement and the Asset Purchase Agreement constitute a legal, valid and binding obligation of Horizon, enforceable against Horizon in accordance with its respective terms, subject to any applicable bankruptcy, insolvency, reorganization, moratorium or similar laws now or hereinafter in effect relating to creditors’ rights generally or to general principles of equity.

 

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7.2 Consents and Approvals. There are no consents, approvals, permits, authorizations, waivers or other actions by, or filings with or notifications to, any Governmental Authority that are required to be obtained or made by Horizon in connection with the execution, delivery and performance by Horizon of this Agreement or the Asset Purchase Agreement or the performance of Horizon’s obligations hereunder or thereunder, except where the failure to obtain such consents or to make such filings or give such notice would not have a material adverse effect on Horizon’s ability to consummate the Contemplated Transactions, other than as required by the HSR Act, if applicable, and any applicable filing, notification or approval in any foreign jurisdiction required by Antitrust Laws.

7.3 Funding. As of the Effective Date, Horizon has sufficient unrestricted cash on hand or other sources of immediately available funds to enable Horizon to make all required payments set forth in Sections 5.1 and 5.2 to the Company. Horizon represents and warrants that all funds paid to the Company shall not have been derived from, or constitute, either directly or indirectly, the proceeds of any criminal activity under the anti-money laundering Laws of the United States or any other jurisdiction.

7.4 No Proceedings. There are no Proceedings pending, or to the knowledge of Horizon, threatened against or affecting Horizon which has or might be reasonably expected to materially affect the Horizon’s ability to perform any of its obligations under this Agreement or the consummation of the Contemplated Transactions.

7.5 No Other Representations or Warranties. EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT AND THE ASSET PURCHASE AGREEMENT, HORIZON EXPRESSLY DISCLAIMS (AND THE COMPANY ACKNOWLEDGES AND AGREES) ANY REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR USE, NON-INFRINGEMENT, VALIDITY AND ENFORCEABILITY OF PATENTS, OR THE PROSPECTS OR LIKELIHOOD OF DEVELOPMENT OR COMMERCIAL SUCCESS OF COMPOUNDS OR PRODUCTS.

ARTICLE VIII

ACTION PRIOR TO THE OPTION TERMINATION

8.1 Investigation by Horizon; Information Rights.

(a) Beginning on the Effective Date through the earlier of (i) the Closing and (ii) the termination of this Agreement pursuant to Article X (the “Pre-Closing Period”), the Company shall afford to the officers, employees and authorized representatives of Horizon and its Affiliates (including independent public accountants, financial advisors, environmental consultants and attorneys) reasonable access under the supervision of appropriate personnel of the Company during normal business hours (and subject to receipt of reasonable notice and such Persons being bound by enforceable confidentiality obligations) to the offices, properties, employees and scientific, business, financial, corporate and legal books and records of the

 

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Company to the extent related to the Development Program, the Acquired Assets or is otherwise reasonably necessary to enable Horizon or its representatives to evaluate whether it intends to exercise the Option and the Company shall furnish to Horizon or its authorized representatives such additional information concerning the assets, properties, operations and business of the Company pertaining to the Acquired Assets as shall be reasonably requested. Horizon agrees that such investigation shall be conducted in such a manner as to not interfere unreasonably with the operations of the Company. Nothing herein shall require the Company to disclose any information to Horizon if such disclosure would (A) based upon the advice of counsel, cause to be waived any attorney-client or other legal privilege or (B) contravene any applicable Law, fiduciary duty, binding agreement in effect as of the date hereof, or any confidentiality agreement in effect as of the date hereof to which the Company is a Party with respect to confidential information of the Parties thereto (other than the Company).

(b) Horizon will hold any information obtained pursuant to this Section 8.1 in confidence in accordance with, and will otherwise be subject to, the provisions of Article XI. No investigation made by Horizon or its representatives hereunder shall affect the representations and warranties of the Company under this Agreement or the Asset Purchase Agreement.

8.2 Notification of Certain Matters. During the Pre-Closing Period, each Party shall promptly notify the other of any Proceeding that shall be instituted or, to the Knowledge of the Company or the Knowledge of Horizon, as applicable, threatened against such Party to restrain, prohibit or otherwise challenge the legality of any transaction contemplated by this Agreement or the Asset Purchase Agreement.

8.3 Covenants of the Company During the Pre-Closing Period. At all times during the Pre-Closing Period, the Company shall:

(a) carry on and operate the Specified Business in the ordinary course (except as specifically required by this Agreement or the Asset Purchase Agreement) and use commercially reasonable efforts to (i) preserve intact the Specified Business, (ii) keep available, subject to turn-over and attrition in the ordinary course, the services of its employees and consultants and those employees and consultants of its Affiliates who conduct any Development Program activities, and (iii) preserve relationships with material suppliers, licensors, vendors and others having a business relationship with the Specified Business;

(b) conduct the Specified Business in such a manner as to comply in all material respects with applicable Laws;

(c) use commercially reasonable efforts to maintain the Acquired Assets in good operating condition and repair or restore such assets as necessary for the operation of the Specified Business in the ordinary course of business, ordinary wear and tear excepted and subject to the shelf life of any inventory;

(d) ensure that, except to the extent otherwise agreed in writing by Horizon, all employees and service providers of the Company or its Affiliates performing activities under the Development Plan have entered or will enter into written agreements with the Company or the applicable Affiliate (i) under which each such individual is obligated to maintain the

 

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confidentiality of the Company’s confidential information and (ii) to assign to the Company or to grant the Company an exclusive license (with the right to grant sublicenses and for sublicensees to further sublicense) for use with Products, under all right, title and interest in and to such Person’s Inventions covering the composition, manufacture or use of any Compound or Product, whether or not patentable, if any, as is reasonable and customary in agreements of that type if it is reasonably anticipated that material Inventions related to a Product will be made by such Person in performing such services for the Company; without limiting the foregoing, the Company will comply in all material respects with all applicable procedures related to assignments mandated by the applicable Laws;

(e) ensure that, except to the extent otherwise agreed in writing by Horizon and subject to applicable Laws, employees (at vice president level and above) and any service provider (who is engaged to perform a role equivalent to vice president level or above in lieu of an employee) of the Company or its Affiliate performing activities under the Development Plan enter into written agreements with the Company under which each such individual is obligated, during the term of their employment or engagement with the Company or its Affiliate not to engage in any employment or other business activities that are Competitive Activities;

(f) use commercially reasonable efforts to protect its ownership of, or rights in, all Program Technology, including Compounds or Products, and shall not make any of its trade secrets or other material Confidential Information related to Program Technology available to any other Person except (i) pursuant to written agreements requiring such Person to maintain the confidentiality of such information or (ii) to attorneys or advisors who otherwise have a legal or ethical obligation to maintain the confidentiality of such information;

(g) use commercially reasonable efforts to prosecute patent applications within, maintain issued patents within and, enforce against infringement (including not waiving any rights, and taking affirmative action to preserve any claims, to the extent the Company has the right to do so pursuant to the applicable license) Patents within or relating to the Program Technology, including Compounds or Products;

(h) prepare and maintain budgets and operating statements of expenses incurred in connection with the activities of the Company contemplated by this Agreement; and

(i) maintain, at its sole cost and expense, $[***] per occurrence and $[***] annual aggregate commercial general liability insurance and $[***] per occurrence and $[***] annual aggregate umbrella liability, as well as $[***] per event and $[***] annual aggregate, clinical trial insurance and products liability coverage (all policies must provide contractual liability coverage), and comply with the minimum insurance required in each country or jurisdiction in which it develops, manufactures, uses, commercializes or otherwise exploits any Compound or Product.

 

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8.4 Restrictions on Conduct of Business by the Company. Without limiting the generality of the provisions of Section 8.3, except as required by applicable Law, as expressly contemplated by this Agreement or the Development Plan, in furtherance of the Development Program, or as Horizon shall otherwise consent to in writing (such consent not to be unreasonably withheld, conditioned or delayed), the Company shall not, and shall cause its Affiliates not to, during the Pre-Closing Period:

(a) employ (or use any contractor or consultant that employs) any individual or entity that it knows (i) is debarred by the FDA (or subject to a similar sanction of any other applicable Regulatory Authority), (ii) is the subject of an FDA debarment investigation or proceeding (or similar proceeding of any other applicable Regulatory Authority), or (iii) has been charged with or convicted under applicable Laws for conduct relating to the Development Program activities, or otherwise relating to the regulation of any product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct of its activities under this Agreement;

(b) shall use commercially reasonable efforts to ensure that its and its Affiliates’ directors, officers, agents and employees shall not, in connection with the Company’s business, (i) use any funds for unlawful contributions, gifts, entertainment or other unlawful expenses, including expenses related to political activity, (ii) make any unlawful payment to foreign or domestic government officials or employees or to foreign or domestic political parties or campaigns, made any bribes or kickback payments or violated in any material respect any provision of the OECD antibribery convention, or (iii) make any payment to any customer or supplier of the Company or give any other consideration to any such customer or supplier in respect of the Company’s business, or make any other payment in respect of the Company’s business, that violates applicable Laws;

(c) declare, set aside or pay any dividends on, or make any other actual, constructive or deemed distributions in respect of, any of its stockholder interests, or otherwise make any payments to any stockholder in its capacity as such as would reasonably be expected to prohibit or materially interfere with or delay the Company’s ability to perform its obligations under this Agreement (including funding of development costs) or the Asset Purchase Agreement;

(d) amend the Certificate of Incorporation or the Company’s bylaws in a manner which would prohibit or materially interfere with or delay the exercise of the Option by Horizon or the consummation of the Contemplated Transactions;

(e) voluntarily dissolve or liquidate;

(f) file a voluntary petition in bankruptcy or commence a voluntary legal procedure for reorganization, arrangement, adjustment, release or composition of indebtedness in bankruptcy or other similar Laws now or hereafter in effect, consent to the entry of an order for relief in an involuntary case under any such Laws or apply for or consent to the appointment of a rescuer, liquidator, assignee, custodian or trustee (or similar office) of the Company;

(g) except as approved in accordance with Section 2.2(a)(iii) by the JSC, enter into, terminate or materially extend, amend, modify or waive any right with respect to any Acquired Business Contract or any contract relating to the activities under the Development Plan that are intended or would reasonably be expected to be an Acquired Business Contract, except for purchase orders entered in the ordinary course of business and clinical trial agreements;

 

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(h) enter into, or amend or otherwise modify any Contract (other than Contracts with Horizon or any of its Affiliates) (i) imposing non-competition restrictions on the Company, committing the Company to exclusivity, or pursuant to which the Company grants exclusive rights or licenses, in each case, primarily related to the Acquired Assets, (ii) that would, by its terms, reasonably be expected to grant any covenant not to sue, immunity from suit or similar rights, most favored nation pricing or exclusive rights to a counterparty, in each case, relating to any Compound, Product, Program Technology or Acquired Asset following the consummation of the Contemplated Transactions, (iii) that would require, in connection with the Contemplated Transactions, the procurement of any consent, waiver or novation or provide for any material change in the obligations of any Party in connection with, or accelerate or terminate as a result of the consummation of, the Contemplated Transactions (in each case, other than in the ordinary course of business), or (iv) except as permitted under this Agreement or the Development Plan, or as approved by the JSC, that grants any Person (other than Horizon or any of its Affiliates) development, marketing or other commercialization rights of any kind or scope with respect to Products or any Program Technology or other Acquired Assets, whether or not such grant is conditional or contingent;

(i) transfer, sell, lease, license or dispose of, or mortgage or pledge, or impose any Lien (other than Permitted Liens) on, any of the Acquired Assets or other material assets used by the Company in the performance of its obligations under this Agreement (real or personal, tangible or intangible), other than the sale of obsolete equipment for immaterial amounts in the ordinary course of business;

(j) sell, lease, license, abandon, permit to lapse, or otherwise transfer, or impose any Lien (other than Permitted Liens) on, any of the Program Technology (other than nonexclusive licenses in the ordinary course of business);

(k) commence, terminate or materially modify the Clinical Trials related to the Product, other than as set forth in the Development Plan;

(l) waive or release any claims or right of material value, in each case related to any Acquired Assets or any Assumed Liabilities (as defined in the Asset Purchase Agreement);

(m) commence any material Proceeding, or settle, pay, discharge, or satisfy any Proceeding where such settlement, payment, discharge, or satisfaction would reasonably be expected to impose any restrictions or limitations upon the Acquired Assets after the Closing;

(n) incur or guarantee any indebtedness or modify existing indebtedness that would reasonably be expected to prohibit or materially interfere with or delay the Company’s ability to perform its obligations under this Agreement or the Asset Purchase Agreement;

(o) terminate, amend, or waive any right, or fail to comply with any obligations, under the License Agreement (as amended to date, the “BMS License Agreement”), dated as of September 14, 2019, between the Company and Bristol-Myers Squibb Company (“BMS”) as amended by the Letter Agreement dated October 9, 2020, Amendment 1 dated August 13, 2021, Amendment 2 dated July, 26, 2022, and Amendment 3 dated July, 26, 2022; or

(p) enter into any agreement or make any commitment, in each case, to take any action expressly prohibited by this Section 8.4.

 

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Nothing contained herein shall give Horizon, directly or indirectly, the right to control or direct the operations of the Company or its Affiliates prior to the Closing. Prior to the Closing, each of Horizon and the Company shall exercise, consistent with the terms and conditions hereof, complete control and supervision of its and its Affiliates’ respective operations.

8.5 Acquisition Proposal. During the Pre-Closing Period, the Company shall not, nor shall it authorize or permit any of its Affiliates, enter into any agreement with respect to, otherwise approve or recommend, or consummate any Acquisition Proposal with any Third Party unless such Third Party guarantees in writing the Company’s continuing obligations under this Agreement and the Asset Purchase Agreement and such Third Party (a) has a market capitalization based on the volume weighted average stock price for the 30-day period ending 30 days prior to public announcement of such Acquisition Proposal of at least 500 million United States dollars, or (b) has a tangible net worth of at least 125 million United States dollars based on a balance sheet prepared in accordance with GAAP dated as of a month ended no more than 30 days prior to the anticipated closing of such Acquisition Proposal, or (c) has cash or cash equivalents, net of aggregate indebtedness and accrued liabilities, based on a balance sheet prepared in accordance with GAAP dated as of a month ended no more than 30 days prior to the anticipated closing of such Acquisition Proposal equal to or greater than 180 million United States dollars and the Company provides to Horizon a copy of such guarantee and evidence of the satisfaction of the market capitalization, tangible net worth or balance sheet cash criteria. The Company shall advise Horizon of the execution of a definitive agreement relating to any Acquisition Proposal (i) at least [***] prior to the closing of the anticipated transaction, if the Company is not publicly traded at such time, or (ii) after public announcement of such transaction, but at least [***] prior to the closing of the anticipated transaction, if the Company is publicly traded at such time. For purposes of this Agreement, “Acquisition Proposal” means any proposal specifically relating to a Change in Control of the Company.

8.6 Financial Information. During the Pre-Closing Period, the Company shall provide to Horizon monthly statements of direct expenses incurred in the Development Program reconciled against the budget included in the Development Plan, which statements shall be provided as promptly as practicable, but in any event within 21 days after the end of each month.

8.7 Required Post-Signing Third Party Consents. Promptly, but in no event later than 60 days, after the Effective Date, the Company shall deliver to Horizon the consents or authorizations (in a form reasonably acceptable to Horizon) set forth on Annex VI (the “Required Post-Signing Third Party Consents”).

ARTICLE IX

INDEMNIFICATION

9.1 Indemnification by the Company.

The Company agrees to indemnify and hold harmless each Horizon Group Member from and against any and all Losses incurred by such Horizon Group Member in connection with or arising from: (a) any breach by the Company of any of its covenants or agreements, or any failure of the Company to perform any of its obligations, in this Agreement, (b) any Third Party claim or claims against any Horizon Group Member to the extent arising out of any activities conducted by or on behalf of the Company, and (c) any Later Imposed Withholding.

 

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9.2 Limitations. The rights of the Horizon Group Members to indemnification are subject to the following limitations:

(a) The aggregate amount which all of the Horizon Group Members will be entitled to receive for indemnification claims under this Agreement shall not exceed the total amounts actually paid by Horizon to the Company under this Agreement.

(b) The amount of any Losses incurred by any Horizon Group Member shall be reduced by any amount actually recovered by such Horizon Group Member with respect thereto under any insurance coverage (net any costs and expenses, including deductibles, costs of recovery and the amount of any insurance premium increases).

(c) Each Horizon Group Member shall use commercially reasonable efforts to mitigate any Losses for which it seeks indemnification under this Article IX; provided, however, that no such Horizon Group Member shall be required to take any action or refrain from taking any action that is contrary to any applicable Contract or Laws binding on such Horizon Group Member, make any insurance claims or commence litigation against any Third Party.

(d) There shall be no multiple recovery for duplicate Losses under this Agreement, or multiple recovery for duplicate Losses under this Agreement, the Asset Purchase Agreement or any Related Agreement (as defined in the Asset Purchase Agreement).

9.3 Notice of Claims.

(a) Any Horizon Group Member (the “Indemnified Party”) seeking indemnification hereunder shall give to the Company (the “Indemnitor”) prompt written notice (a “Claim Notice”) describing in reasonable detail the facts giving rise to any claim for indemnification hereunder and shall include in such Claim Notice (to the extent then known) the amount or the method of computation of the amount of such claim, and a reference to the provision of this Agreement upon which such claim is based; provided, that a Claim Notice in respect of any pending or threatened action or proceeding at law or suit in equity by or against a Third Party as to which indemnification will be sought (each such action or suit being a “Third Party Claim”) shall be given promptly after the action or suit is commenced; provided, further, that failure to give such notice shall not relieve the Indemnitor of its obligations hereunder except to the extent it shall have been prejudiced by such failure.

(b) After the giving of any Claim Notice pursuant hereto, the amount of indemnification to which an Indemnified Party shall be entitled under this Article IX shall be determined as set forth in Section 12.16.

 

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9.4 Indemnification Procedures.

(a) The Indemnitor shall have the right to conduct and control, through counsel reasonably acceptable to the Indemnified Party, the defense, compromise or settlement of any Third Party Claim as to which indemnification will be sought by any Indemnified Party from any Indemnitor hereunder by delivering written notice to the Indemnified Party within 10 days after the Indemnitor’s receipt of the Claim Notice relating to such Third Party Claim, and in any such case the Indemnified Party shall cooperate in connection therewith and shall furnish such records, information and testimony and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested and subject to reasonable notice by the Indemnitor in connection therewith; provided, that:

(i) the Indemnitor shall keep the Indemnified Party reasonably informed of all material events related to such Third Party Claim;

(ii) the Indemnified Party may participate, through counsel chosen by it and at its own expense, in the defense of any such Third Party Claim as to which the Indemnitor has so elected to conduct and control the defense thereof; and

(iii) the Indemnitor shall not, without the prior written consent of the Indemnified Party (which written consent shall not be unreasonably withheld), pay, compromise or settle any such Third Party Claim.

Notwithstanding the foregoing, the Indemnitor shall have the right to pay, settle or compromise any such Third Party Claim without such consent; provided, that such payment, settlement or compromise by its terms obligates the Indemnitor to pay the full amount of the liability in connection with such Third Party Claim and includes an unconditional release of such Indemnified Party from all liability arising out of such Third Party Claim.

(b) Notwithstanding anything in Section 9.4(a) or anything else contained herein to the contrary, the Indemnitor shall not be entitled to have sole control over the defense, settlement or compromise of any Third Party Claim: (i) that seeks an order, injunction or other equitable relief against any Indemnified Party or any of its Affiliates; or (ii) in which both the Indemnitor and the Indemnified Party are named as parties and either the Indemnitor or the Indemnified Party reasonably determines with advice of counsel that there may be one or more material legal defenses available to it that are different from or additional to those available to the other party or that a conflict of interest between such parties may exist in respect of such Third Party Claim; provided, that:

(i) the Indemnified Party shall keep the Indemnitor reasonably informed of all material events related to such Third Party Claim;

(ii) the Indemnitor may participate, through counsel chosen by it and at its own expense, in the defense of any such Third Party Claim as to which the Indemnified Party has so elected to conduct and control the defense thereof; and

(iii) the Indemnified Party shall not, without the prior written consent of the Indemnitor (which written consent shall not be unreasonably withheld), pay, compromise or settle any such Third Party Claim.

Notwithstanding the foregoing, the Indemnified Party shall have the right to pay, settle or compromise any such Third Party Claim without such consent; provided, that in such event the Indemnified Party shall waive any right to indemnity therefor hereunder unless such consent is unreasonably withheld.

 

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9.5 Tax Treatment of Indemnification Payments. The Parties agree to treat any indemnification amount payable pursuant to this Agreement as an adjustment to the consideration paid pursuant to this Agreement to the extent permissible by applicable Law.

ARTICLE X

TERMINATION

10.1 Automatic Termination. Anything contained in this Agreement to the contrary notwithstanding, unless earlier terminated pursuant to Section 10.2 or clause (C) of Section 2.5, this Agreement will automatically terminate on the earliest to occur of: (i) the Option Termination Date, if the Option is not validly exercised prior to such date, or (ii) the Closing Date.

10.2 Early Termination. At any time prior to automatic termination of this Agreement in accordance with Section 10.1, this Agreement may be terminated:

(a) by either the Company or Horizon if the JSC determines that the continuation of the Development Program would be commercially unreasonable, or scientifically or operationally unviable; or

(b) by Horizon:

(i) upon written notice to the Company following the payment of all Development Funding to the Company;

(ii) upon [***] prior written notice to the Company, if Horizon determines in good faith that, based on (A) the feedback from FDA, (B) any clinical hold or FDA request for further information that cannot be resolved within a reasonable amount of time, or (C) any safety issue, it is commercially unreasonable, or scientifically or operationally unviable, to continue development of Compounds and Products;

(iii) concurrently with delivery of an Interest Withdrawal Notice pursuant to Section 4.4(c); or

(iv) at any time after the expiration of the Company Delivery Period if the Company has not delivered the Updated APA Schedules to Horizon prior to the expiration of the Company Delivery Period; or

(c) by the Company or Horizon (“Non-Breaching Party”) at any time in the event the other Party (“Breaching Party”) is in breach of any of its material obligations under this Agreement; provided that the right to terminate this Agreement for breach pursuant to this Section 10.2(c) shall not be available to a Party if such breach directly resulted from such Party’s breach of any of its material obligations under this Agreement; provided, further, that (i) the NonBreaching Party shall provide written notice to the Breaching Party, which notice shall identify the breach; (ii) the Breaching Party shall have a period of [***] after such written notice is provided to cure such breach; and (iii) if such breach is not cured within such [***] period, then absent withdrawal of the Non-Breaching Party’s request for termination, this Agreement shall terminate effective as of the expiration such [***] period.

 

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10.3 Effect of Termination. In the event that this Agreement is terminated pursuant to this Article X or Section 2.5, all rights and obligations of the Parties under this Agreement (other than with respect to the Company’s reimbursement obligations, and Horizon’s rights thereto, under Section 2.5, or under Article I (Definitions), Section 3.6(a) (Ownership), Section 6.7 (No Other Representations or Warranties), Section 7.5 (No Other Representations or Warranties), this Section 10.3 (Effect of Termination), Article XI (Confidentiality) and Article XII (General Provisions)) shall be terminated and automatically become void without further liability of either Party to the other; provided, however, that nothing herein shall relieve either Party of any obligation or liability accruing prior to such expiration or termination, nor shall expiration or any termination of this Agreement preclude either Party from pursuing all rights and remedies it may have under this Agreement, at law or in equity, with respect to breach of this Agreement.

ARTICLE XI

CONFIDENTIALITY

11.1 Confidentiality.

(a) Non-Use and Non-Disclosure. During the term of this Agreement and for 10 years thereafter, a Receiving Party shall (i) treat in confidence Confidential Information provided by a Disclosing Party as it would treat its own information of a similar nature, (ii) take all reasonable precautions not to disclose such Confidential Information to Third Parties, without the Disclosing Party’s prior written consent, provided that Horizon may disclose Confidential Information of the Company to its counsel, accountants and financial advisors, or its and its Affiliates’ employees, consultants and subcontractors (the “Horizon Representatives”), and the Company may disclose Confidential Information of Horizon its counsel, accountants and financial advisors, its and its Affiliates’ employees, consultants and subcontractors or the Representative (as defined in the Asset Purchase Agreement) (the “Company Representatives”), in either case who have a need to know such Confidential Information for purposes related to this Agreement or the Asset Purchase Agreement and are bound by obligations of confidentiality and non-use, and (iii) not use such Confidential Information (and ensure that the Horizon Representatives or the Company Representatives, as applicable do not use such Confidential Information) other than for exercising the Receiving Party’s rights or fulfilling its obligations under this Agreement, for the purpose of evaluating the proposed Asset Acquisition as permitted by the Asset Purchase Agreement; provided, however, that after the Closing, Horizon may use or disclose any Confidential Information related to the Acquired Assets and such information shall be deemed Confidential Information of Horizon.

(b) Permitted Disclosure. Notwithstanding the obligation of non-use and nondisclosure set forth in Section 11.1(a) and Section 11.1(c), the Parties recognize the need for certain exceptions to this obligation.

(i) Court or Administrative Order. A Receiving Party shall be entitled to disclose Confidential Information of Disclosing Party to the extent that such disclosure is required to comply with a court or administrative order provided that the Receiving Party furnishes prompt notice (in no event less than 3 days), to the extent legally permissible, to the Disclosing Party to enable it to resist such disclosure.

 

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(ii) Press Releases. The Company shall only issue press releases related to the activities contemplated by this Agreement that have either (A) been approved by Horizon, such approval not to be unreasonably withheld or (B) are required to be issued by the Company under applicable Laws based upon advice of counsel. The Company shall provide Horizon with a draft press release at least [***] prior to its intended publication for Horizon’s review. If Horizon asks for modification, then the Company shall either make such modification or work with Horizon to arrive at a press release that Horizon approves. Notwithstanding the foregoing, each Party may make any public statement in response to questions by the press, analysts, investors or those attending industry conferences or financial analyst calls, or issue press releases, so long as any such public statement or press release is consistent with prior public disclosures or public statements approved pursuant to this Section 11.1(b)(ii) and which do not reveal nonpublic information about the other Party. If the filing of this Agreement with the U.S. Securities and Exchange Commission or any stock exchange on which securities issued by a Party or its Affiliate are traded is required by applicable Laws, the Parties shall coordinate in advance with each other in connection with such filing and each Party will use reasonable efforts to seek confidential treatment for the terms proposed to be redacted; provided that each Party will ultimately retain control over what information to disclose to any Governmental Authority or any stock exchange as the case may be.

(iii) Legal Requirements. The Receiving Party may disclose Confidential Information of the Disclosing Party to the extent that such Confidential Information is required to be disclosed by the Receiving Party to comply with applicable Laws, to defend or prosecute litigation or to comply with governmental regulations, provided that the Receiving Party provides prior written notice of such disclosure to the Disclosing Party, to the extent legally permissible, and, to the extent practicable, takes reasonable and lawful actions to minimize the degree of such disclosure.

(c) Terms of this Agreement. The Parties agree that the terms of this Agreement will be considered Confidential Information of both Parties. Subject to Section 11.1(b) and except as set forth below, no Party shall, without the prior written consent of the other Party, disclose in any manner to any Third Party the terms of this Agreement, except for terms or subject matter which has been the subject of prior public disclosure or has been mutually approved by the Parties in writing for such disclosure. Each Party acknowledges that the other Party may be legally required to file this Agreement as an exhibit to its filings with an applicable securities regulator (for example, as may pertain to the U.S. Securities and Exchange Commission), subject to customary and legally permitted redaction of Confidential Information of the other Party. In addition: (i) either Party may disclose such terms as are required to be disclosed in its publicly-filed financial statements or other public statements, pursuant to applicable Laws and stock exchange rules (e.g., the rules of the U.S. Securities and Exchange Commission, or any other stock exchange on which securities issued by either Party may be listed); provided that, such Party shall, to the extent permitted and if feasible in light of applicable time constraints, provide the other Party with a copy of the proposed text of such statements or disclosure (including any exhibits containing this Agreement) sufficiently in advance (to the extent possible) of the scheduled release or publication thereof to afford such other Party a reasonable opportunity to review and comment

 

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upon the proposed text (including redacted versions of this Agreement), and (ii) either Party shall have the further right to disclose the terms of this Agreement under a confidentiality obligation substantially similar to those set forth in this Agreement (but of duration customary in confidentiality agreements entered into for a similar purpose), to any actual or potential sublicensee, strategic partner, collaborator, acquirer, merger partner, underwriter, investor, lender or other provider of financing, and the employees, directors, agents, consultants and advisors of any such Third Party. Notwithstanding the foregoing, the Company shall only disclose to BMS a redacted version of this Agreement and the Asset Purchase Agreement that is agreed to by the Parties in advance of such disclosure.

11.2 Publications. During the term of the Agreement, the following restrictions shall apply with respect to disclosure by either Party of Confidential Information relating to the Product in any publication or presentation:

(a) Policy Regarding Publication. The Parties acknowledge that it is their policy for the studies and results thereof to be registered and published in accordance with their internal guidelines. The Company shall have the right to publish all studies, Clinical Trials and results thereof on the Clinical Trial registries that are maintained by or on behalf of the Company. Horizon shall not publish any studies, Clinical Trials or results thereof on its Clinical Trial registry, provided, however, that the Company’s Clinical Trial registry can be accessed via a link from Horizon’s Clinical Trial registry.

(b) Review Procedure. A Party (“Publishing Party”) shall provide the other Party with a copy of any proposed publication or presentation that contains non-public information related to the Program Technology or any Compound or Product (each, a “Proposed Publication”) at least 30 days (or at 10 days in the case of oral presentations) prior to submission for publication or the applicable presentation so as to provide such other Party with an opportunity to recommend any changes it reasonably believes are necessary to continue to maintain the Confidential Information disclosed by the other Party to the Publishing Party in accordance with the requirements of this Agreement. The incorporation of such timely recommended changes shall not be unreasonably refused; and if such other Party notifies (“Publishing Notice”) the Publishing Party in writing, within 30 days after receipt of the copy of the Proposed Publication (or at least 10 days in the case of the Proposed Publication is an oral presentation), that such Proposed Publication (i) contains an Invention owned by the other Party, for which the other Party reasonably desires to obtain patent protection or (ii) would be expected to have a material adverse effect on the commercial value of any Confidential Information disclosed by the other Party to the Publishing Party, the Publishing Party shall prevent such publication or delay such Proposed Publication for a mutually agreeable period of time. In the case of Inventions, a delay shall be for a period reasonably sufficient to permit the timely preparation and filing of a patent application(s) on such Invention, and in no event less than 90 days from the date of the Publishing Notice. Once a Proposed Publication has been mutually agreed to, no additional approvals will be required to subsequently present or publish the same information that was covered in the Proposed Publication.

11.3 Prior Non-Disclosure Agreements. As of the Effective Date, the terms of this Article XI shall supersede any prior non-disclosure, secrecy or confidentiality agreement between the Parties (or their Affiliates), including the Confidentiality Agreements, dealing with the subject of this Agreement. Any information disclosed under such prior agreements shall be deemed disclosed under this Agreement.

 

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11.4 Equitable Relief. Given the nature and value of the Confidential Information and the competitive damage and irreparable harm that might result to a Party upon unauthorized disclosure, use or transfer of its Confidential Information to any Third Party, the Parties agree that monetary damages may not be a sufficient remedy for any breach of this Article XI. If the Receiving Party becomes aware of any breach or threatened breach of this Article XI by a Third Party to whom the Receiving Party disclosed the Disclosing Party’s Confidential Information, the Receiving Party promptly shall notify the Disclosing Party and cooperate with the Disclosing Party to regain possession of its Confidential Information and prevent any further breach. In addition to all other remedies, a party shall be entitled to specific performance pursuant to Section 12.14.

ARTICLE XII

GENERAL PROVISIONS

12.1 Notices. Any notice or other communication required or permitted to be delivered to any Party under this Agreement shall be in writing and shall be deemed properly delivered, given and received (a) upon receipt when delivered by hand, (b) upon transmission, if sent by electronic transmission (in each case with receipt verified by electronic confirmation) or (c) one Business Day after being sent by courier or express delivery service, provided that in each case the notice or other communication is sent to the address or facsimile telephone number set forth beneath the name of such Party below (or to such other address or facsimile telephone number as such Party shall have specified in a written notice given to the other Parties hereto):

If to the Company, to:         Q32 Bio Inc.

Attn: Michael Broxson, CEO

830 Winter Street, 2nd Floor

Waltham, MA 02451

USA

with a required copy (which shall not constitute notice):

Goodwin Procter LLP

Attn: Kingsley L. Taft and Laurie A. Burlingame

100 Northern Avenue

Boston, MA 02210

USA

If to Horizon, to:                 Horizon Therapeutics Ireland DAC

70 St. Stephen’s Green

Dublin 2, D02 E2X4

Ireland

Attn: General Counsel

 

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with copies (which shall not constitute notice) to:

Horizon Therapeutics USA, Inc.

1 Horizon Way

Deerfield, IL 60015

USA

Attn: General Counsel

Cooley LLP

4401 Eastgate Mall

San Diego, CA 92121

USA

Attention: Barbara Borden, L. Kay Chandler

e-mail: [***]

or to such other address as such Party may indicate by a notice delivered to the other Party hereto.

12.2 Successors and Assigns. Neither this Agreement nor any of the rights, interests or obligations under this Agreement may be assigned, in whole or in part, by either the Company or Horizon without the prior written consent of the other Party; provided, that, (a) Horizon may assign this Agreement to any of its Affiliates or to a successor in interest in connection with the merger, consolidation, or sale of all or substantially all of its assets or that portion of its business pertaining to the subject matter of this Agreement, (b) subject to Section 8.5, the Company may assign this Agreement to a successor in interest in connection with the merger, consolidation, or sale of all or substantially all of its assets or that portion of its business pertaining to the subject matter of this Agreement, and (c) no assignment shall relieve either Party of its obligations hereunder. Any assignment in violation of the preceding sentence will be null and void. This Agreement will be binding upon, inure to the benefit of, and be enforceable by, the Parties and their respective successors and permitted assigns.

12.3 Entire Agreement; Severability. This Agreement, the Asset Purchase Agreement and their respective annexes, schedules, exhibits, and agreements referred to herein and therein constitute the entire agreement, and supersede all prior agreements and understandings, both written and oral, among the Parties with respect to the subject matter hereof and thereof, including the Confidentiality Agreements. If any term, condition or other provision of this Agreement is found to be invalid, illegal or incapable of being enforced by virtue of any rule of law, public policy or court determination, all other terms, conditions and provisions of this Agreement shall nevertheless remain in full force and effect. If the final determination of any arbitration process or final judgment of a court of competent jurisdiction, in each case, to the extent in accordance with the terms of this Agreement, declares that any term or provision hereof is invalid or unenforceable, the arbitrators or court making the determination of invalidity or unenforceability shall have the power to limit the term or provision, to delete specific words or phrases, or to replace any invalid or unenforceable term or provision with a term or provision that is valid and enforceable and that comes closest to expressing the intention of the invalid or unenforceable term or provision, and this Agreement shall be enforceable as so modified.

 

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12.4 Export Control. This Agreement is made subject to any restrictions concerning the export of products or technical information from the U.S. or other countries which may be imposed upon or related to the Company or Horizon from time to time. Each Party agrees that it shall not export, directly or indirectly, any technical information acquired from the other Party under this Agreement or any products using such technical information to a location or in a manner that at the time of export requires an export license or other governmental approval, without first obtaining the written consent to do so from the appropriate agency or other Governmental Authority.

12.5 Compliance with Applicable Laws. Each Party shall comply with applicable Laws in the course of performing its obligations or exercising its rights pursuant to this Agreement. Neither Party (nor any of their Affiliates) shall be required under this Agreement to take any action or to omit to take any action otherwise required to be taken or omitted by it under this Agreement if the taking or omitting of such action, as the case may be, would in its opinion violate any settlement, consent order, corporate integrity agreement, or judgment to which it may be subject from time to time during the term of this Agreement. .

12.6 Performance by Affiliates. Subject to the terms and conditions of this Agreement, each Party may discharge any obligations and exercise any right hereunder through any of its Affiliates. Each Party hereby guarantees the performance by its Affiliates of such Party’s obligations under this Agreement, and shall cause its Affiliates to comply with the provisions of this Agreement in connection with such performance. Any breach by a Party’s Affiliate of any of such Party’s obligations under this Agreement shall be deemed a breach by such Party, and the other Party may proceed directly against such Party without any obligation to first proceed against such Party’s Affiliate.

12.7 Further Actions. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

12.8 Amendments and Waivers. This Agreement may not be amended or modified, nor may compliance with any condition or covenant set forth herein be waived, except by a writing duly and validly executed by Horizon and the Company or, in the case of a waiver, the Party waiving compliance. Except as specifically set forth herein to the contrary, no delay or omission by either Party in exercising any right or power occurring upon any noncompliance or default by the other Party with respect to any of the terms of this Agreement shall impair any such right or power or be construed to be a waiver thereof. A waiver by either Party of any of the covenants, conditions or agreements to be performed by the other shall not be construed to be a waiver of any succeeding breach thereof or of any other covenant, condition or agreement herein contained.

12.9 Third Person Beneficiaries. This Agreement shall not benefit or create any right or cause of action in or on behalf of any Person other than the Parties and their respective successors and permitted assigns and nothing herein, whether express or implied, is intended to or shall confer upon any other Person any legal or equitable right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.

 

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12.10 Expenses. Each Party will pay all costs and expenses incident to its negotiation and preparation of this Agreement and to its performance and compliance with all agreements and conditions contained herein on its part to be performed or complied with, including the fees, expenses and disbursements of its counsel and accountants.

12.11 Counterparts; Signatures. This Agreement may be executed in one or more counterparts, all of which will be considered one and the same agreement and will become effective when one or more counterparts have been signed by each of the Parties and delivered to the other Party. This Agreement may be executed by facsimile signature or by an electronic scan delivered by electronic mail.

12.12 Attorneys’ Fees. If any action or proceeding relating to this Agreement or the enforcement of any provision of this Agreement is brought against any Party hereto, the prevailing Party shall be entitled to recover reasonable attorneys’ fees, costs and disbursements (in addition to any other relief to which the prevailing Party may be entitled).

12.13 Time is of the Essence. Time is of the essence of this Agreement and the performance of the Parties’ respective rights and obligations hereunder.

12.14 Specific Performance. The Parties agree that irreparable damage would occur in the event that any of the terms or provisions of this Agreement were not performed in accordance with their specific wording or were otherwise breached. The Parties accordingly agree that, in the event of any breach or threatened breach by any Party of any covenant, obligation or other provision set forth in this Agreement, for the benefit of the other Party: (a) such other Party shall be entitled (in addition to any other remedy that may be available to it) to: (i) a decree or order of specific performance or mandamus to enforce the observance and performance of such covenant, obligation or other provision; and (ii) an injunction restraining such breach or threatened breach; and (b) such other Party shall not be required to provide any bond or other security in connection with any such decree, order or injunction or in connection with any related action or legal proceeding.

12.15 Relationship of the Parties. Nothing contained in this Agreement shall be deemed or construed to create a partnership, joint venture, employment, franchise, agency or fiduciary relationship between Horizon and the Company. Neither Party shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement or undertaking with any Third Party. Neither Party shall treat or report the relationship arising under this Agreement as a partnership for United States Tax purposes unless required pursuant to a determination under Section 1313 of the Code.

12.16 Governing Law; Disputes.

(a) Governing Law. This Agreement shall be governed by and construed and enforced under the substantive laws of the State of New York, excluding (i) any conflicts or choice of law rule or principle that might otherwise make this Agreement subject to the substantive law of another jurisdiction; (ii) the United Nations Conventions on Contracts for the International Sale of Goods; (iii) the 1974 Convention on the Limitation Period in the International Sale of Goods; and (iv) the Protocol amending the 1974 Convention, done at Vienna April 11, 1980. For clarification, any dispute relating to the inventorship, scope, validity, enforceability or infringement of any patent right shall be governed by and construed and enforced in accordance with the patent laws of the applicable jurisdiction.

 

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(b) Referral to Executives. In the event of any dispute in connection with this Agreement, subject to the authority of the JSC and final decision-making under Section 2.5, such dispute shall be referred to the respective Executive of the Parties or their designees, for good faith negotiations attempting to resolve the dispute.

(c) Jurisdiction. Should the Executives of the Parties be unable to resolve such dispute within two months after such dispute has first been referred to them, either Party may pursue any remedy available to such Party at law or in equity, subject to the terms and conditions of this Agreement. Horizon and the Company each hereby irrevocably: (i) consents to submit itself in any suit, action or proceeding arising out of or related to this Agreement or any of the Contemplated Transactions to the exclusive personal jurisdiction of the courts of the State of New York sitting in New York County, New York; (ii) agrees that it will not attempt to defeat or deny such personal jurisdiction by motion or other request for leave from such court; and (iii) agrees that it will not bring any action arising out of or related to this Agreement or any of the Contemplated Transactions in any court other than any such court.

(d) Tolling. All time periods set forth herein shall be tolled during pendency of any dispute brought in accordance with the terms of this Agreement.

12.17 Waiver of Jury Trial. EACH OF HORIZON AND THE COMPANY HEREBY IRREVOCABLY AND UNCONDITIONALLY WAIVES ALL RIGHT TO TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM (WHETHER BASED ON CONTRACT, TORT OR OTHERWISE) ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE ACTIONS OF HORIZON OR THE COMPANY IN THE NEGOTIATION, ADMINISTRATION, PERFORMANCE AND ENFORCEMENT HEREOF.

12.18 Independent Contractor. No employee or representative of either Party shall have any authority to bind or obligate the other Party for any sum or in any manner whatsoever or to create or impose any contractual or other liability on the other Party without said Party’s prior written approval. For all purposes, and notwithstanding any other provision of this Agreement to the contrary, the relationship between the Parties shall be that of independent contractors.

[Remainder of page intentionally left blank; signature page follows.]

 

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IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed the as of the Effective Date.

 

Q32 BIO INC.
By:   /s/ Michael Broxson
Name:   Michael Broxson
Title:   CEO
HORIZON THERAPEUTICS IRELAND DAC
By:    
Name:    
Title:    

Signature Page to Collaboration and Option Agreement

 

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HORIZON THERAPEUTICS IRELAND DAC
By:   /s/ William D. Gannon
Name:   William D. Gannon
Title:   Director

Signature Page to Collaboration and Option Agreement

 

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Annex I

Asset Purchase Agreement

[Intentionally Omitted]

 

50


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ANNEX II

Initial Development Plan

[Intentionally Omitted]

 

51


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ANNEX III

Patent Jurisdictions

[Intentionally Omitted]

 

52


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ANNEX IV

Option Package

[Intentionally Omitted]

 

53


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ANNEX V

Required Signing Third Party Consents

[Intentionally Omitted]

 

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ANNEX VI

Required Post-Signing Third Party Consents

[Intentionally Omitted]

 

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ANNEX VII

Development Funding Schedule – Following Payment of the Option Fee Set Forth in Section 5.1

 

1.

Within 20 days after the Initiation of the Phase 2 Clinical Trial of the Compound for Atopic Dermatitis: $17,500,000

 

2.

Within 20 days after ordering materials for the July ‘23 GMP run: $2,000,000, not to be ordered earlier than January 1, 2023

 

3.

Within 20 days after the Initiation of the Phase 2 Clinical Trial of the Compound for Alopecia Areata: $17,500,000

 

4.

Within 20 days after completion of the non-GMP confirmation run: $3,000,000

 

56

Exhibit 10.38

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

TERMINATION AGREEMENT

This Termination Agreement (this “Agreement”) is entered into as of November 10, 2023 (the “Termination Date”) by and between Q32 Bio Inc. (“Q32”) and Horizon Therapeutics Ireland DAC (“Horizon”). Each of Q32 and Horizon may be referenced hereto as a “Party” and collectively, the “Parties.”

RECITALS

WHEREAS, Q32 and Horizon are parties to that certain Collaboration and Option Agreement, dated as of August 12, 2022, by and between Q32 and Horizon (the “Collaboration Agreement”) and that certain Asset Purchase Agreement, dated as of August 12, 2022, by and between Q32 and Horizon (the “Purchase Agreement”).

WHEREAS, under the Collaboration Agreement, Q32 grants to Horizon an option to purchase certain assets of Q32, on the terms of and subject to the conditions set forth in the Collaboration Agreement and the Purchase Agreement (the “Option”).

WHEREAS, the Parties intend to terminate the Collaboration Agreement and the Purchase Agreement prior to the exercise of the Option.

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties hereto agree as follows:

AGREEMENT

1. Definitions. Capitalized terms shall have the meanings set forth in Annex I attached hereto or otherwise defined herein.

2. Termination of the Collaboration Agreement and the Purchase Agreement. The Parties mutually agree that, notwithstanding anything to the contrary in the Collaboration Agreement and the Purchase Agreement, effective as of the Termination Date, each of the Collaboration Agreement and the Purchase Agreement is hereby terminated, subject to the terms in this Agreement.

3. No Rights Transferred to Horizon. As of the Termination Date, Horizon has not exercised the Option and therefore, no right, title or interest in or to or otherwise relating to the Compound or Product (including any Product IP) has been or shall be licensed or otherwise transferred to Horizon, and the Option is hereby terminated. Horizon further confirms that, other than consulting services provided by Horizon to Q32 in connection with the Collaboration Agreement, neither Horizon nor any of its Affiliates has performed any research or development activities relating to the Compound or Product. For purposes of the preceding sentence, the term Affiliates does not include any entities that became affiliates of Horizon following the October 6, 2023 acquisition of Horizon by Amgen Inc.


4. Milestone Payments. In partial consideration of this Agreement, Q32 shall make the following payments (each, a “Milestone Payment”) to Horizon (or its designated Affiliates) within thirty (30) days after achieving each of the following milestone events (each, a “Milestone Event”):

 

Milestone Event

   Payment Amount  

[***]

   $ [***]  

[***]

   $ [***]  

[***]

   $ [***]  

[***]

   $ [***]  

[***]

   $ [***]  

[***]

   $ [***]  

If there is more than one Product sold by the Selling Party, then the Net Sales of all such Products shall be included for purposes of determining the applicable Milestone Event. For clarity, each Milestone Payment shall be payable only once and the maximum amount of Milestone Payments payable by Q32 shall be $75,100,000.

5. VAT on Payments. All payments due under this Agreement are exclusive of VAT. If any VAT is chargeable in respect of amounts payable pursuant to this Agreement, VAT shall be charged at the applicable rate required by applicable Law and the Party making such payment shall pay the VAT amount on receipt of a VAT invoice in the appropriate form.

6. Exchange Rate; Manner and Place of Payment; Late Payments. All payment amounts specified in this Agreement are expressed in U.S. Dollars, and all payments due hereunder shall be payable in U.S. Dollars. When conversion of payments from any currency other than U.S. Dollars is required, such conversion shall be calculated using the exchange rate published by The Wall Street Journal, Eastern U.S. Edition, on the last day of the calendar quarter in which the applicable Net Sales are made. All payments owed under this Agreement shall be made by wire transfer in immediately available funds to a bank and account designated in writing by Horizon, unless otherwise specified in writing by Horizon. If Horizon does not receive payment of any sum due to it hereunder on or before the due date therefor, simple interest shall thereafter accrue on the sum due from the due date, including from when a payment was determined to have been due until the date of payment at a per-annum rate of [***]% above the prime rate as reported in The Wall Street Journal, Eastern U.S. Edition on the date such payment is due (or the next closest Business Day), or the maximum rate allowable by applicable Law, whichever is less (the “Late Interest Rate”).

7. Withholding. Q32 and its agents (as applicable) shall be entitled to deduct and withhold from any amounts payable or otherwise deliverable pursuant to this Agreement such amounts as Q32 is required to deduct or withhold therefrom under any applicable Laws and shall pay the amounts withheld to the appropriate Governmental Authority. To the extent such amounts are so deducted or withheld and properly remitted to the appropriate Governmental Authority, Q32 will send evidence of the obligation together with proof of Tax payment to Horizon on a reasonable and timely basis following such Tax payment. Any amounts properly deducted and withheld by Q32 or its agent from payment to Horizon shall be treated for all purposes under this Agreement as having been paid to Horizon. Each Party agrees to use commercially reasonable efforts to cooperate with the other Party in claiming refunds, reductions, or exemptions from such deductions

 

2


or withholdings under any relevant agreement or treaty that is in effect. Horizon will provide Q32 with any Tax forms or other documentation reasonably necessary in order for Q32 not to withhold or to withhold Tax at a reduced rate under an applicable bilateral income Tax treaty. Notwithstanding the foregoing, if withholding is required under applicable Laws and such withholding payments result from a Withholding Action by Q32 or its Affiliates then Q32 shall pay an additional amount to Horizon such that, after withholding from the payments provided for in this Agreement and such additional amount, Horizon receives the same after-withholding amount as it would have received from Q32 absent such deduction or withholding and such additional amount.

8. Reports. Following the Termination Date, Q32 shall provide Horizon with a written report on an annual basis (or more frequently upon reasonable request of Horizon or its Affiliates) summarizing development, regulatory and commercialization activities of the Product(s). Each such report shall be Confidential Information of Q32.

9. Audit Rights. Q32 shall keep complete and accurate records of the underlying revenue and expense data relating to the calculations of Net Sales and payments required under this Agreement. Horizon shall have the right, for no more than [***], at its own expense, to have an independent, certified public accountant, selected by Horizon, review the records of Q32 upon reasonable notice (which shall be no less than [***] prior written notice) and during regular business hours. Horizon’s audit rights with respect to any calendar year shall expire [***] after the end of such year; provided, however, that the books and records for any particular calendar year shall only be subject to [***]. Should the inspection lead to the discovery that one or more Milestone Payments was due to Horizon, but not paid, Q32 shall pay [***]. In the event that an audit performed in accordance with the guidelines specified above does not resolve a dispute between the Parties, then such dispute shall be governed by the terms of Section 12.16 of the Collaboration Agreement (Governing Law; Disputes), which shall apply to this Agreement, mutandis mutatis.

10. BMS License. If the BMS License Agreement is terminated, then any amounts received by Q32 or any of its Affiliates from BMS or any of its Affiliates in connection with a Licensed Product or a BMS Reversion Product (each as defined in the BMS License Agreement) (including under Section 13.4.11 of the BMS License Agreement) shall be used to pay Horizon any amounts owed hereunder (including for achievement by Product(s) of the Milestone Events). Any Transfer to BMS, other than a Transfer that occurs solely as a result of the termination of the BMS License Agreement (which is addressed in the preceding sentence), shall be subject to the terms of Section 11 below.

11. Conditions to Transfer. Q32 shall not, and shall cause any Transferee not to, Transfer or permit a Transfer to any other Person, unless (a) such Person expressly agrees in writing to be bound by the payment and other obligations of Q32 to Horizon set forth in this Agreement, (b) Horizon is made an express third party beneficiary of the applicable portions of such written agreement, and (c) Q32 or its successor in interest remains primarily responsible to Horizon for the obligations of Q32 in this Agreement.

 

3


12. Surviving Obligations. Following the Termination Date, Section 10.3 (Effect of Termination) of the Collaboration Agreement and Section 10.3 (Effect of Termination) of the Purchase Agreement shall survive in accordance with the terms therein, and for clarity, Section 2.5 of the Collaboration Agreement shall not apply for purposes of this Agreement. Other than the foregoing, and the rights and obligations of each Party under this Agreement, nether Party shall have any rights or obligations (financial or otherwise) against the other Party under the Collaboration Agreement or the Purchase Agreement.

13. Confidentiality. This Agreement shall be governed by Article XI (Confidentiality) of the Collaboration Agreement, mutandis mutatis, provided that the term “Confidential Information” shall include any such information disclosed by a Party or its Affiliates to the other Party or its Affiliates in connection with or for the purposes of this Agreement. The terms of this Agreement shall be considered Confidential Information of both Parties.

14. Miscellaneous. The terms set forth in Article XII (General Provisions) of the Collaboration Agreement shall apply to this Agreement, mutandis mutatis, provided that (a) the phrase “subject to Section 8.5” in subclause (b) of Section 12.2 (Successors and Assigns) shall be removed for purposes of this Agreement, and (b) Section 12.3 (Entire Agreement; Severability) shall be construed to include this Agreement, the Collaboration Agreement, and the Purchase Agreement.

[Signature Pages Follow]

 

4


Confidential

IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed as of the date set forth above by their duly authorized representatives.

 

Q32 BIO INC.
By:   /s/ Jodie Morrison
Name:   Jodie Morrison
Title:   CEO
HORIZON THERAPEUTICS IRELAND DAC
By:   /s/ David Caraher
Name:   David Caraher
Title:   Director

 

Signature Page to Termination Agreement


Annex I

Definitions

“Acquired Assets” has the meaning given in the Purchase Agreement.

“Affiliate” means, as to any Person, any other Person that, directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with that Person, but only for so long as such control exists. For purposes of this definition, “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”), as used with respect to any Person or group of Persons, means possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of the Person, whether (a) through direct or indirect beneficial ownership of at least 50% (or such lesser percentage which is the maximum allowed to be owned by a foreign entity in a particular jurisdiction) of the voting stock or other ownership interest in such corporation or other entity, or (b) by contract.

“Annual Net Sales” means, with respect to a Product, total worldwide Net Sales of such Product during a calendar year.

“BMS License Agreement” means the License Agreement, dated as of September 14, 2019, between Q32 and Bristol-Myers Squibb Company (“BMS”) as amended, including by the Letter Agreement dated October 9, 2020, Amendment 1 dated August 13, 2021, Amendment 2 dated July 26, 2022, and Amendment 3 dated July 26, 2022.

“Business Day” means any day that is not a Saturday, a Sunday or other day on which banks are required or authorized by Law to be closed in Ireland, the State of Illinois, the State of California or the State of Massachusetts.

“Change in Control” means, with respect to a Party, (a) a merger, consolidation, reorganization, amalgamation, arrangement, share exchange, tender or exchange offer, private purchase, business combination or other transaction of such Party with a Third Party that results in the voting securities of such Party outstanding immediately prior thereto, or any securities into which such voting securities have been converted or exchanged, ceasing to represent more than 50% of the combined voting power of the surviving entity or the parent of the surviving entity immediately after such merger or consolidation, (b) a transaction or series of related transactions in which a Third Party, together with its Affiliates, becomes the direct or indirect beneficial owner of more than 50% of the combined voting power of the outstanding securities of such Party, provided that a sale of securities for bona fide fundraising purposes shall not be deemed a Change in Control for purposes of this Agreement, or (c) the sale or other transfer to a Third Party of all or substantially all of the assets of such Party and its direct and indirect subsidiaries.

“Combination Product” means a [***].

“Compound” means the fully humanized, high affinity anti-interleukin-7 receptor a antagonist antibody known as ADX-914, as set forth on a schedule delivered to Horizon in connection with the execution and delivery of the Collaboration Agreement and all modifications, derivatives, fragments or variants thereof.


“Exploitation” means, with respect to the Compound or Product, the research, development, manufacture, formulation, testing, use, distribution, marketing, sale, promotion, and other commercialization and exploitation of the Compound or Product.

“Governmental Authority” means any United States federal, state, local, or any non-U.S. government, governmental, regulatory (including self-regulatory) or administrative authority, body, agency or commission or any court, tribunal, or judicial or arbitral body.

“Invention” means an invention, including any improvement or modification, that was made during the term of the Collaboration Agreement by one or more individuals conducting development, regulatory, toxicology or manufacturing activities with respect to the Compound and Product(s) by or on behalf of a Party or any of its Affiliates.

“Know-How” means data, knowledge, trade secrets, know-how, discoveries, inventions and technical, business or other proprietary information, including materials, samples, manufacturing data, chemistry, manufacturing, and controls information, toxicological data, pharmacological data, data from preclinical, clinical or non-clinical testing or studies, assays, processes, protocols, procedures, methods, devices, designs, results, technology, platforms, formulations, regulatory filings, applications, approvals and associated correspondence, specifications, quality control testing data, customer lists, mailing lists and business plans.

“Laws” means any United States federal, state and local, and any non-U.S., laws, statutes, regulations, rules, codes or ordinances enacted, adopted, issued or promulgated by any Governmental Authority or common law.

“Net Sales” means, [***].

“Patents” means any and all (a) issued patents; (b) pending patent applications, including all priority patent applications, substitutions, continuations (in whole or in part), request for continued examination, divisions and renewals, and all patents granted thereon; (c) patents-of-addition, reissues, reexaminations, supplemental examinations and extensions or restorations by existing or future extension or restoration mechanisms, including patent term adjustments, patent term extensions, supplementary protection certificates or the equivalent thereof; (d) certificates of invention and applications for certificates of invention; (e) other forms of government-issued rights substantially similar to any of the foregoing; and (f) United States and foreign counterparts of any of the foregoing.

“Person” means any individual, corporation, partnership, joint venture, limited liability company, association, joint-stock company, trust, unincorporated organization or Governmental Authority.

“Product” means any product comprised of or containing the Compound, in any form or formulation.

“Product IP” means all Know-How and Patents that are (a) owned or controlled by Q32 or any of its Affiliates that are used or held for use in, are necessary or reasonably useful for, the Exploitation of the Compound or Product, or (b) generated by or on behalf of either Party or both Parties in the Exploitation of the Compound or Product under the Collaboration Agreement.


“Regulatory Approval” means, with respect to any Product in any regulatory jurisdiction, approval from the applicable regulatory authority for the manufacture, distribution, use, marketing, and sale of the Product in such jurisdiction in accordance with applicable Laws provided, however that for purposes of the U.S., Regulatory Approval means NDA Approval, for purposes of the European Union, Approval means MAA Approval. For purposes of this definition, “NDA” means a new drug application filed with the FDA required for marketing approval for the applicable Product in the U.S., or, if the Compound is a biologic, a biologics license application (BLA) filed with the FDA required for marketing approval for the applicable Product in the U.S. “MAA Approval” means Regulatory Approval by the EMA of a marketing authorization application (including an abbreviated application) filed with the EMA for the applicable Product under the centralized European procedure; provided, that MAA Approval shall in any event be deemed achieved upon First Commercial Sale in any country in the European Union. “First Commercial Sale” means, with respect to a Product in a country, the first sale for use or consumption by the general public of such Product in such country after Regulatory Approval of such Product has been granted, or such marketing and sale is otherwise permitted, by the regulatory authority of such country. First Commercial Sale will not include distribution or other sale solely for clinical trials or under patient assistance, named patient use, compassionate use, or other patient access programs, in each case, where the Product is supplied without charge or below or at the actual manufacturing cost thereof or any early access programs before reimbursement approvals are obtained in countries where reimbursement approval is required.

“Subject Assets” means all or substantially all of the assets and rights of Q32 or any subsidiary of Q32 relating to the development, manufacture or commercialization of Compounds and Products. The Acquired Assets and the BMS License Agreement are Subject Assets.

“Tax” or “Taxes” means any and all federal, provincial, territorial, state, municipal, local, foreign or other taxes (including imposts, rates, levies, assessments, and other charges, in each case in the nature of a tax), including all income, excise, franchise, gains, capital, real property, goods and services, transfer, value added, gross receipts, windfall profits, severance, ad valorem, personal property, production, sales, use, license, stamp, documentary stamp, mortgage recording, employment, payroll, social security, unemployment, disability, estimated or withholding taxes, and all customs and import duties, together with all interest, penalties and additions to tax (and additional amounts imposed with respect to such amounts).

“Third Party” means any Person other than a Party hereto or an Affiliate of a Party hereto.

“Transfer” means any transfer, sale, license, conveyance or assignment of Subject Assets, including any transfer, sale, license, conveyance assignment of the Acquired Assets or the BMS License Agreement, in any transaction or series of related transactions, including through a Change in Control of Q32 or any successor in interest, a merger, consolidation, reorganization, amalgamation, arrangement, share exchange, tender or exchange offer, business combination, sale of securities, sale of assets, license, or comparable transaction.

“Transferee” means any Affiliate of Q32 or Third Party to which a Transfer is made by Q32 or by any Affiliate or Third Party that acquired Subject Assets directly or indirectly from Q32.


“VAT” means value added tax, sales taxes, consumption taxes and other similar taxes imposed or required by applicable Law.

“Withholding Action” means (a) a permitted assignment of this Agreement (in whole or in part) by Q32 to any Person outside of the United States or Ireland; (b) the exercise by Q32 of its rights under this Agreement (in whole or in part) through any Person outside of the United States or Ireland (or the direct exercise of such rights by an Affiliate of such party outside of the United States or Ireland); and (c) a redomiciliation of Q32, an assignee or a successor to a jurisdiction outside the United States or Ireland.

Exhibit 10.39

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL

EXCLUSIVE LICENSE AGREEMENT

Parties to the Agreement: AdMiRx, University

University Case Numbers: [***]

TABLE OF CONTENTS

Article 1 - Definitions

Article 2 - Grant and Reservation of Rights

Article 3 - Economic Consideration

Article 4 - Sublicensing

Article 5 - U.S. Government Rights

Article 6 - Reports, Records, and Audits

Article 7 - Confidential Information

Article 8 - Export

Article 9 - Patent Prosecution

Article 10 - Patent Enforcement

Article 11 - Warranties, Indemnifications, and Insurance

Article 12 - Duration, Conditions, Termination, and Conversion

Article 13 – General

*****

Appendix A - Technology Specific Terms and Conditions

Appendix B - Diligence Report

Appendix C - Form of Royalty Report


This EXCLUSIVE LICENSE AGREEMENT between The Regents of the University of Colorado, a body corporate, for and on behalf of the University of Colorado Denver (the “University”) and AdMiRx, Inc. a Delaware corporation (“Licensee” has the meaning assigned to it in Article 1) is effective on 9th of August, 2017, (the “Effective Date”).

BACKGROUND

 

  1.

The University is the owner or co-owner of the Licensed Patents and Diagnostic Patents and is the owner of part of the Licensed Information (“Licensed Patents” and “Licensed Information” have the meanings assigned to them in Article 1) related to University Case Number(s) [***] and [***].

 

  2.

MUSC Foundation for Research Development (“MUSC FRD”) is a co-owner with University of the Licensed Patents related to University Case Number [***] and owner of part of the Licensed Information, and MUSC FRD has entered into an inter-institutional agreement with University whereby MUSC FRD has authorized University to license and administer MUSC FRD’s interest in such Licensed Patents and Licensed Information, on behalf of the Medical University of South Carolina (“MUSC”).

 

  3.

The University and MUSC FRD want the Licensed Information and the invention(s) described in the Licensed Patents, developed and marketed as soon as possible so that the resulting products may be available for public use and benefit.

 

  4.

The Licensee desires to license the Licensed Patents, Diagnostic Patents and Licensed Information for the purpose of developing and commercializing products covered by the Licensed Patents and Licensed Information.

Accordingly, the parties agree as follows:

GENERAL TERMS AND CONDITIONS

Article 1 Definitions

1.1 Definitions. The terms defined in the Preamble have their assigned meanings and the following terms, whether used in the singular or plural, have the meanings assigned to them.

 

  (a)

“Affiliate” means any entity that controls, is controlled by, or is under common control with Licensee. Control means the

 

  (i)

direct or indirect ownership of at least 50% of voting securities;

 

  (ii)

power to govern the financial and operating policies of the entity; or

 

  (iii)

power to appoint the management of the entity.

 

Exclusive License Agreement    Page 2 of 34    CU Case Numbers [***]


For the avoidance of doubt, Affiliates of Licensee excludes any entity other than Licensee and its subsidiaries controlled by [***] under common control of [***] or any investor in [***].

 

  (b)

“Agreement” means this Exclusive License Agreement, including all Appendices hereto, as amended from time to time.

(c) “Diagnostic Patents” means

 

  (i)

The United States and foreign patent(s) or nonprovisional patent application(s) or provisional patent applications listed in Appendix A, the patents issued therefrom, including any reissues, reexaminations, extensions of such patents, and any registrations, supplementary protection certificates and renewals of any such patents or patent applications, and all rights and priorities in any of the foregoing.

 

  (ii)

All divisionals and continuations that take priority from those patents and patent applications listed in Appendix A, and the patents issued therefrom, including any reissues, reexaminations, extensions of such patents, and any registrations, supplementary protection certificates and renewals of any such patents or patent applications, and all rights and priorities in any of the foregoing.

 

  (iii)

Claims of any continuations-in-part applications that take priority from those patents and patent applications listed in Appendix A and resulting patents that are directed to subject matter described in the patents and patent applications listed in Appendix A, registrations, supplementary protection certificates and renewals of any such patents or patent applications, and all rights and priorities in any of the foregoing.

 

  (d)

“Diligence Report” has the meaning assigned to it in Appendix B.

 

  (e)

“Fair Market Value” means the cash price that would be paid in an arm’s length transaction between two unrelated parties.

 

  (f)

“Field of Use” has the meaning assigned to it in Appendix A.

 

  (g)

“First Commercial Sale” means, with respect to a Licensed Product, the first sale for end use or consumption of such product in a country after marketing approval has been granted in such country. First Commercial Sale excludes any sale or other distribution of such product for use in a clinical trial or other development activity, promotional use (including samples) prior to marketing approval or for compassionate use or on a named patient basis.

 

  (h)

“Generic Product” means, with respect to a Licensed Product in a particular country, any product that (a) is sold by a third party under a marketing authorization granted by a regulatory authority in such country to such third party, (b) contains the same active pharmaceutical ingredient as such Licensed Product, and (c) is approved by the regulatory authority in such country pursuant to an approval process that relies in part on pivotal safety or efficacy data in such regulatory authority’s previous grant of marketing authorization for such Licensed Product.

 

Exclusive License Agreement    Page 3 of 34    CU Case Numbers [***]


  (i)

“Improvement” means (i) any invention, the practice of which would also require the practice of an invention claimed in or covered by the Licensed Patents or which is a modification or derivative of the inventions claimed in or covered by the Licensed Patents, and all patent rights arising therefrom, and (ii) at least one (and possibly both if there is further collaboration) of the following clauses (A) and (B):

 

  (A)

made solely by or on behalf of Dr. Michael Holers or Dr. Joshua Thurman or University researchers working in the laboratories of Dr. Michael Holers or Dr. Joshua Thurman, so long as Dr. Michael Holers or Dr. Joshua Thurman, respectively, is an employee of University.

 

  (B)

made solely by or on behalf of Dr. Stephen Tomlinson or MUSC researchers working in the laboratory of Dr. Stephen Tomlinson, so long as Dr. Stephen Tomlinson is an employee of MUSC.

(j) “Insolvency” means

 

  (i)

having generally ceased to pay debts in the ordinary course of business other than as a result of a bona fide dispute;

 

  (ii)

being unable to pay debts as they become due: or

 

  (iii)

being insolvent within the meaning of federal bankruptcy law.

 

  (k)

“Licensee” means the entity listed in the Preamble and any of its Affiliates.

 

  (l)

“Licensed Information” means all inventions, biological materials (including the biological materials set forth on Appendix D) and reagents, concepts, processes, information, data, and know-how that:

 

  (i)

Are owned by the University as of the Effective Date and were discovered in the laboratories of Dr. Michael Holers or Dr. Joshua Thurman, are owned by MUSC FRD as of the Effective Date and were discovered in the laboratory of Dr. Stephen Tomlinson, or are co-owned by University and MUSC-FRD as of the Effective Date and were discovered in the laboratories of Dr. Michael Holers, Dr. Joshua Thurman, and/or Dr. Stephen Tomlinson; and

 

  (ii)

Are useful for the discovery, development, manufacture, use, or sale of compositions that inhibit complement activation; and

 

  (iii)

Are not covered by any Valid Claim.

 

Exclusive License Agreement    Page 4 of 34    CU Case Numbers [***]


(m) “Licensed Patents” means

 

  (i)

The United States and foreign patent(s) or nonprovisional patent application(s) or provisional patent applications listed in Appendix A, the patents issued therefrom, including any reissues, reexaminations, extensions of such patents, and any registrations, supplementary protection certificates and renewals of any such patents or patent applications, and all rights and priorities in any of the foregoing.

 

  (ii)

All divisional and continuations that take priority from those patents and patent applications listed in Appendix A, and the patents issued therefrom, including any reissues, reexaminations, extensions of such patents, and any registrations, supplementary protection certificates and renewals of any such patents or patent applications, and all rights and priorities in any of the foregoing.

 

  (iii)

Claims of any continuations-in-part applications that take priority from those patents and patent applications listed in Appendix A and resulting patents that are directed to subject matter described in the patents and patent applications listed in Appendix A, registrations, supplementary protection certificates and renewals of any such patents or patent applications, and all rights and priorities in any of the foregoing.

(n) “Licensed Product” means

 

  (i)

Any product, service, or process the making, use, offer for sale, sale, or importation or rendering of which, absent a license, would infringe one or more Valid Claims in the country in which it is made, used, sold, offered for sale, imported, or rendered; or any product which is manufactured, or any service which is rendered, using a process which would infringe one or more Valid Claims in the country in which it is made, used, sold, offered for sale, imported or rendered.

 

  (ii)

Any product, service, or process, or any product which is manufactured, or any service which is rendered, using a process, that has been or is discovered or is further developed, in whole or in part, through the use of the Licensed Information, whether the Licensed Information was used prior to or after the Effective Date, or that requires the use of the Licensed Information for its manufacture, use or sale.

 

  (iii)

Any product, service, or process, or any product which is manufactured, or any service which is rendered, using a process, that has been or is discovered or is further developed, in whole or in part, through the use of any information, concepts, know-how, data, images, or figures that is disclosed in the specification of any of the Licensed Patents, whether such information, concepts, know-how, data, images, or figures were used prior to or after the Effective Date, or that requires the use of the information, data, or figures for its manufacture, use or sale.

 

Exclusive License Agreement    Page 5 of 34    CU Case Numbers [***]


  (o)

“MUSC” has the meaning assigned to it in the Background.

 

  (p)

“MUSC FRD” has the meaning assigned to it in the Background.

 

  (q)

“MUSC Entities” has the meaning assigned to it in Article 2.3(c).

 

  (r)

“Net Sales” means the gross amounts invoiced on sales of any Licensed Products by the Licensee or Sublicensees. Net Sales excludes the following items, but only to the extent they pertain to sales arising from any Licensed Products, are included in gross sales, are separately stated on purchase orders, invoices, or other documents of sale, and are reported on the relevant Royalty Report:

[***]

Net Sales also includes [***], for the sale of Licensed Products.

For the absence of doubt, Net Sales only includes the sale of Licensed Products between the Licensee and its Affiliates and Sublicensees where the purchaser is the end user, and, where such sales to Affiliates and Sublicensees are not final sales, includes the downstream sale to third party customers and distributors.

In the event that a Licensed Product is sold as a Combination Product, Net Sales, for the purposes of determining royalty payments on the Combination Product, means the gross amount collected for the Combination Product less the deductions set forth in [***] above, multiplied by a proration factor that is determined as follows:

[***]

 

  (s)

“Notice Date” means the date the party to whom notice is sent receives the notice at the address indicated in Article 13.2. Notice Date does not mean actual notice.

 

  (t)

“Option Period” has the meaning assigned to it in Article 2.5.

 

  (u)

“Option Rights” has the meaning assigned to it in Article 2.5.

 

  (v)

“Recipient” means a party who receives information from the other party to this Agreement.

 

  (w)

“Royalty Report” is included as Appendix C and described in Article 6.1.

 

  (x)

“Royalty Term” means the period beginning on the First Commercial Sale of a Licensed Product in any country and ending on the later of (a) on a Licensed Product-by-Licensed Product and country-by-country basis, the expiration date of the last to expire patents within the Licensed Patents that covers the making, use, offer for sale, sale, importation or rendering of such Licensed Product in the relevant country, or (b) twenty (20) years from the Effective Date.

 

Exclusive License Agreement    Page 6 of 34    CU Case Numbers [***]


  (y)

“Senior Executives” means a person with authority to contractually bind the party.

 

  (z)

“Sublicense” means a grant of rights to a third party under the rights granted under Article 2.1 hereof.

 

  (aa)

“Sublicensee” means any third party granted a Sublicense.

 

  (bb)

“Sublicense Income” means all consideration received by the Licensee from a Sublicensee as consideration for the grant of a Sublicense or an option for a Sublicense. Such consideration includes without limitation any upfront, license initiation or signing fees, license maintenance fees, milestone payments, unearned portion of any minimum annual royalty payment, payments associated with an acquisition or liquidation of the assets of the Sublicensee that may be deferred or trailing payments, equity and the Fair Market Value of any non-cash consideration paid to Licensee for the Sublicense.

Sublicense Income excludes

 

  (i)

sums received as royalties on Net Sales by the Sublicensees, such Net Sales being subject to the royalty on Net Sales in Appendix A, or, provided that such royalties for Net Sales of such Licensed Product are paid, sums received by Licensee as a percentage of profits earned by the Sublicensee on sales of Licensed Products. Licensee shall notify the University that a Sublicense includes such a profit share arrangement when it submits a copy of the executed Sublicense agreement under Article 4, or if the profit share arrangement is set forth in a separate agreement from the Sublicense agreement, Licensee shall provide the University with a copy of the agreement setting forth the profit share arrangement with the copy of the Sublicense agreement under Article 4.);

 

  (ii)

amounts paid for debt or equity of the Licensee up to its Fair Market Value;

 

  (iii)

payments or reimbursement of patent prosecution, defense, enforcement and maintenance and other related expenses to the extent such expenses were not already deducted from sums paid to the University; or,

 

  (iv)

payments or reimbursement for research and development and commercialization activities up to the actual cost of performing such research, development and commercialization activities and solely to the extent the payments are expressly identified in the relevant Sublicense as payments or reimbursement for research and development or for commercialization activities (it being understood that commercialization activities means those activities related to manufacturing for sale, marketing, promoting and selling any Licensed Products).

 

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Further, if Licensee pays to University a milestone payment under Appendix A for achieving a milestone for which Licensee receives from a Sublicensee, within [***] of said payment to University, a payment for achieving the same or substantially similar milestone, then the amount of Licensee’s payment to University under Appendix A may be deducted by Licensee from such Sublicensee’s payment and will not be included as Sublicense Income hereunder.

To the extent that patent rights, intellectual property rights or rights or obligations other than Licensed Patents or Licensed Information are licensed, sublicensed or granted by Licensee, that portion of the consideration received by Licensee and subject to inclusion as Sublicense Income will be equitably apportioned between the Licensed Patents and Licensed Information and those other rights and obligations, and such apportionment shall be reasonable and in accordance with customary standards in the industry. Licensee shall promptly, but no later than [***] after the date of the final signature to the Sublicense, deliver to University a written report setting forth such apportionment. In the event University disagrees with the determination made by Licensee, University shall so notify Licensee within [***] of receipt of Licensee’s report and the parties shall meet to discuss and resolve such disagreement in good faith. If the parties are unable to agree in good faith as to such fair market value within [***], then the matter shall be resolved in accordance with the dispute resolution process set forth in Article 13.9(a) through (c).

 

  (cc)

“Term” has the meaning assigned to it in Article 12.1.

 

  (dd)

“Territory” has the meaning assigned to it in Appendix A.

 

  (ee)

“University Indemnitees” includes the University, its regents, employees, students, officers, agents, affiliates, representatives, and inventors.

 

  (ff)

“Valid Claim” means a pending or an issued and unexpired claim of a Licensed Patent so long as the claim has not been irrevocably abandoned or declared to be invalid through no fault of the Licensee in a non-appealable decision of a court or other government agency of competent jurisdiction.

 

  1.2

Other Definitional Provisions.

 

  (a)

All references to statutes and related regulations include

 

  (i)

any past and future amendments of those statutes and related regulations; and

 

  (ii)

any successor statues and related regulations.

 

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  (b)

The words “including,” “includes,” and “include” are deemed to be followed by the words “without limitation.”

 

  (c)

The word “or” shall be construed as the inclusive meaning identified with the phrase “and/or.”

1.3 All references to currency in this Agreement such as “Dollars” or “S” refer to the lawful currency of the United States of America.

Article 2 Grant and Reservation of Rights

2.1 License. Subject to the terms and conditions of this Agreement, the University hereby grants to the Licensee

 

  (a)

an exclusive (as to the University and MUSC FRD), sublicensable (through multiple tiers) license to the Licensed Patents,

 

  (b)

an exclusive (as to the University), sublicensable (through multiple tiers) license, subject to any pre-existing third party rights, to the biological materials, reagents, processes and information in which the University has an ownership interest and identified as being exclusively licensed as set forth in Appendix D.

 

  (c)

a non-exclusive, sublicensable (through multiple tiers) license to the biological materials, reagents, processes and information in which the University has an ownership interest and identified as being non- exclusively licensed as set forth in Appendix D.

 

  (d)

an exclusive (as to MUSC-FRD), sublicensable (through multiple tiers) license, subject to any pre-existing third party rights, to the biological materials, reagents, processes and information in which MUSC-FRD has an ownership interest and identified as being exclusively licensed as set forth in Appendix D, and

 

  (e)

a non-exclusive, sublicensable (through multiple tiers) license to the biological materials, reagents, processes and information in which MUSC-FRD has an ownership interest and identified as being non- exclusively licensed as set forth in Appendix D, and

 

  (f)

a non-exclusive, sublicensable (through multiple tiers) license to the Licensed Information (other than the biological materials, reagents, processes and information set forth in Appendix D).

to research, have researched, develop, have developed, commercialize, have commercialized, make, have made, use, have used, import, have imported, offer to sell, have offered to sell, sell, Have Sold and practice the Licensed Products in the Field(s) of Use and the Territory. “Have Sold” means the sale of Licensed Products by distributors and other agents for and on behalf of the Licensee.

 

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2.2 Diagnostic Patents License. Subject to the terms and conditions of this Agreement, the University hereby grants to Licensee a non-exclusive, non- transferable, non-sublicensable, limited, fully paid-up license to the Diagnostic Patents to make, use and practice products or processes covered by the Diagnostic Patents for its own internal, non-commercial research purposes only, provided that the foregoing license is sublicensable to any Sublicensee (including via multiple tiers) for internal, non-commercial research purposes only.

2.3 Reservation of Rights.

 

  (a)

The licenses granted under Article 2.1(a) (b), and (d) are expressly made subject to the University’s reservation, on behalf of itself, MUSC, future not-for-profit employers of the inventors of the Licensed Patents, and all other not-for-profit academic and research institutions, of the right to practice the Licensed Patents and use the biological materials, reagents, processes and information listed on Appendix D for educational, research, non-clinical, or other non-commercial purposes (but in no case when sponsored by any for-profit entity). Notwithstanding the foregoing, University, MUSC-FRD, and MUSC shall not transfer any biological materials set forth on Appendix D as being exclusively licensed to Licensee to any third party without the consent of Licensee, provided that the University, MUSC-FRD, and MUSC may transfer such biological materials set forth on Appendix D to any not-for-profit academic and research institution upon advance written notice to Licensee and under a materials transfer agreement approved by Licensee and attached hereto as Appendix E.

 

  (b)

The exclusive licenses granted under Article 2.1(b) and (d) to the biological materials, reagents, processes and information set forth on Appendix D identified as exclusively licensed to Licensee and the restrictions with regard to the biological materials set forth on Appendix D under Article 2.3(a) are expressly made subject to the University’s, MUSC-FRD’s, and MUSC’s obligations under the National Institutes of Health “Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources,” if applicable, and the University, MUSC-FRD, and MUSC may transfer the biological materials set forth on Appendix D as being exclusively licensed to Licensee to a third party to the extent necessary to comply with the University’s, MUSC-FRD’s, or MUSC’s respective obligations under the National Institutes of Health “Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources.”

 

  (c)

The University retains on behalf of MUSC and the MUSC Entities, the use of Licensed Patents related to [***] and the biological materials, reagents, processes and information set forth on Appendix D as being exclusively licensed to Licensee for medical care purposes, provided that the rights extended for medical care purposes will only apply to circumstances in which MUSC has determined that there is a clinical need for such exercise of the rights, and such rights are limited to patient care provided directly by care providers at the MUSC Entities, “MUSC Entities” means MUSC, MUSC Physicians, the Medical University Hospital Authority, the MUSC Foundation and all entities with MUSC which are under the control of the Board of Trustees of MUSC.

 

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2.4 Limitation on Rights. This Agreement confers no license or rights by implication, estoppel, or otherwise under any patent applications or patents of the University or MUSC FRD other than the Licensed Patents and the Diagnostic Patents, regardless of whether such patents are dominant or subordinate to the Licensed Patents or the Diagnostic Patents.

2.5 Improvements. For a period of [***] from the Effective Date and unless the Agreement is earlier’ terminated. University hereby grants to Licensee an exclusive option to include such Improvements under the license granted in Article 2.1(a) to Licensee, provided that University is not contractually precluded as of the date the Improvement is first disclosed to the University’s CU Innovations from granting such option (the “Option Rights”). As to each such Improvement, the Option Rights terminate [***] from the date a first written disclosure of such Improvement is provided to Licensee by University (the “Option Period”). At any time during the Option Period, Licensee may exercise its Option Rights to the Improvement. In the event that Licensee exercises its Option Rights to any Improvement, this Agreement will be amended to add the Improvement to this Agreement and subject to the terms and conditions of this Agreement for no additional consideration beyond the reimbursement of patent expenses previously incurred by University or MUSC-FRD associated with such Improvements. For the sake of clarity, any Licensed Products based on the Improvements added under this Agreement will be subject to the same obligations regarding the payment of royalties and milestones as any other Licensed Products. In the event the Licensee declines to exercise its Option Rights to any Improvement within the Option Period, then neither party will be under any further obligation to the other with respect to that particular Improvement.

Article 3 Economic Consideration

3.1 As consideration for the license and rights granted under this Agreement, Licensee agrees to pay to the University the economic consideration specified in Appendix A.

Article 4 Sublicensing

4.1 Sublicenses Permitted. The Licensee may grant Sublicenses through multiple tiers.

4.2 Sublicensee Royalties. The Licensee shall do the following:

 

  (a)

Pay royalties on Net Sales by all Sublicensees and a percentage of Sublicense Income as specified in Appendix A.

 

  (b)

Include royalty payment terms, and require all Sublicensees to include royalty payment terms, in all Sublicenses that are consistent with and do not conflict with this Agreement.

 

  (c)

Retain all responsibility for the performance of all Sublicensees under a Sublicense as if the performance was carried out by the Licensee itself, including the payment to the University of any Net Sales royalties and milestone payments specified in Appendix A, regardless of whether the Sublicensee pays the Licensee.

 

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4.3 Required Provisions. The Licensee shall include, and shall require all Sublicensees to include, language consistent with and not in conflict with the following provisions in all Sublicenses:

 

  (a)

Article 3 Economic Consideration, Article 6 Reports, Records and Audits including the University’s direct right to audit the Sublicensee, and Article 11 Warranties, Indemnification, and Insurance.

4.4 Sublicensee Conduct. The Licensee shall cause all Sublicensees to covenant to do the following:

 

  (a)

Not to further sublicense the Licensed Patents or the Licensed Information, unless such further Sublicensee agrees to all relevant terms of this Agreement mutatis mutandis.

 

  (b)

Submit to the University and the Licensee

 

  (i)

Diligence Reports including at least the same level of detail as set forth in Appendix B; and

 

  (ii)

Royalty Reports in the form set forth in Appendix C.

 

  (c)

Agree to, and require its Sublicensee to agree to, terms substantially similar and consistent with Article 5 U.S. Government Rights and Requirements, Article 8 Export, Article 7 Confidential Information and Article 13.14 Survival, in each case, to the extent applicable to Sublicensees.

4.5 Termination of Licenses or Sublicense.

 

  (a)

The Licensee shall cause each Sublicense to be subject to the termination of this Agreement; provided, however, that the Sublicense shall not be subject to the termination of this Agreement if Licensee and its Sublicensee comply with Article 4.5(b) below.

 

  (b)

Notwithstanding Article 4.5(a), in the event this Agreement is terminated pursuant to Articles 12.2, 12.3 or 12.5, the Licensee and its Sublicensee shall agree to assign any Sublicense to the University and such Sublicense shall automatically be assigned to University without any further action at Sublicensee’s request so long as the Sublicensee complies with Article 4, the Sublicensee is not in breach of its Sublicense, and the University is not obligated to incur any obligations or make any representations or warranties in excess of those contained in this Agreement. Any follow-on Sublicenses under a Sublicense assigned to the University will continue according to its terms.

 

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  (c)

The Licensee shall require the automatic termination of a Sublicense and all follow-on Sublicenses under that Sublicense in the event the Sublicensee institutes a legal action challenging the validity of any Licensed Patent.

4.6 Copy of Sublicense. The Licensee shall submit to the University a copy of each fully executed Sublicense agreement and any amendments to Sublicenses granted under this Agreement, in each case, which may be redacted except with respect to matters relating to Licensee’s obligations under this Agreement. The Sublicense agreements and amendments must be postmarked within 30 days of their execution.

Article 5 U.S. Government Rights and Requirements

5.1 The Bayh-Dole Act. The Licensee understands that this Agreement is subject to all of the terms and conditions of 35 U.S.C. §§ 200-212, (“The Bayh- Dole Act”) and 37 C.F.R. § 401. Accordingly, the Licensee shall take all reasonable action necessary to enable the University to satisfy its obligations under The Bayh- Dole Act including the use of commercially diligent efforts to cause any Licensed Products to be manufactured substantially in the United States. Licensee may apply with the appropriate federal agency for a waiver of this manufacturing requirement.

Article 6 Reports, Records, and Audits

6.1 Reports. The Licensee shall submit the following reports to the University via email attachment and writing:

 

  (a)

Diligence Reports as set forth in Appendix B.

 

  (b)

[***] Royalty Reports as set forth in Appendixes A and C for each calendar quarter regardless of any Net Sales beginning in the calendar quarter of the First Commercial Sale.

If the first reporting period is not a complete year or quarter, the Licensee shall, or shall cause the Sublicensee to, report partial periods.

6.2 Records. The Licensee shall do the following:

 

  (a)

Keep accurate records and cause all Sublicensees to keep accurate records in sufficient detail to reflect its operations under this Agreement and to enable the royalties accrued and payable under this Agreement to be determined.

 

  (b)

Retain the records for at least [***] after the close of the period to which they pertain, or for such longer time as may be required to resolve any question or discrepancy raised by the University.

 

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6.3 Audits.

 

  (a)

Upon the request of the University, with reasonable notice, but not more frequently than once a calendar year, the Licensee shall permit an independent public accountant selected and paid by the University and reasonably acceptable to Licensee to have access during regular business hours to records, reports and other information relating to any Sublicense or this Agreement solely to the extent necessary to verify the accuracy of made or payable payments.

 

  (b)

The accountant will disclose information acquired to the University only to the extent that it should properly have been contained in the royalty reports required under this Agreement.

 

  (c)

If an inspection or audit shows an underreporting or underpayment in excess of [***] for any [***], then the Licensee shall reimburse the University for the cost of the inspection or audit and pay the amount of the underpayment including any interest as required by this Agreement.

Article 7 Confidential Information

7.1 Responsibilities. The parties shall vigilantly protect all confidential information disclosed by the other party under this Agreement from disclosure to third parties. The financial terms of this Agreement are considered the confidential information of both parties. The parties shall not make disclosures of the other party’s confidential information without the written permission of the other party, except that the University may disclose confidential information of the Licensee to MUSC FRD as necessary to comply with the terms of the inter-institutional agreement, provided that MUSC FRD has agreed in writing to confidentiality obligations no less strict than this Agreement with regard to Licensee’s confidential information.

7.2 Ownership. All written documents containing confidential information and other material in tangible form received by the Recipient under this Agreement remains the property of the disclosing party. Upon request of the disclosing party, the Recipient shall return such documents to the disclosing party or provide evidence of their destruction.

7.3 Future Information and Inventions. All invention disclosures, scientific data, and business information, reports and records disclosed by either party including the Sublicensees under this Agreement are considered confidential information of the disclosing party.

7.4 Exceptions. Confidential information does not include the following:

 

  (a)

Information which at the time of disclosure had been previously published or was otherwise publicly available through no fault of Recipient.

 

  (b)

Information which becomes public knowledge after disclosure unless such knowledge results from a breach of this Agreement.

 

  (c)

Information which was already in Recipient’s possession prior to the time of disclosure as evidenced by written records kept in the ordinary course of business or by proof of actual use.

 

  (d)

Information that is independently developed without use of the confidential information.

 

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7.5 Authorized Disclosure. Notwithstanding the foregoing, if a party is required by law, court order, or government regulation to disclose the confidential information of the other party, the party required to make such disclosure shall (a) promptly send a copy of the order or notice to the other party not less than [***] before the proposed disclosure (or such shorter period of time as may be reasonably practical under the circumstances): (b) reasonably cooperate with the other party if the other party wishes to object or condition such disclosure through a protective order or otherwise; (c) limit the extent of such disclosure to the minimum required to comply with the order or notice; and (d) use reasonable efforts to seek confidential treatment (i.e., filing “under seal”) for that disclosure, provided that party required to make such disclosure is not required to incur any substantial expenses in obtaining such treatment without reimbursement by the other party. In addition, Licensee may disclose confidential information of the other party to its Affiliates and employees, to actual and potential Sublicensees, collaborators and strategic partners, to investors or potential investors, or to an acquirer or potential acquirer under terms at least as stringent (but of commercially reasonable duration) as those contained herein.

7.6 CORA. The Licensee acknowledges that the University is subject to the Colorado Open Records Act, C.R.S. §§ 24-72-201, et seq. (CORA). All plans and reports marked “Confidential” shall be treated by the University as confidential to the extent permitted under § 24-72-204. Certain categories of information, including trade secrets and information implicating legal privileges, are not required to be released in response to requests for information under CORA.

Article 8 Export

8.1 Export Prohibition. Licensee shall not export or re-export Licensed Patents, Licensed Products, Licensed Information, or confidential information of University to any country, individual, or entity except when such export or reexport is authorized in full compliance with the laws and regulations of the United States, as applicable.

8.2 Applicable Law. Applicable laws and regulations may include but are not limited to the Export Administration Regulations, the International Traffic in Arms Regulations, and the economic sanctions regulations administered by the U.S. Department of the Treasury.

Article 9 [***]

9.1 Licensee’s Responsibilities. The Licensee shall assume primary responsibility for preparing, filing and prosecuting reasonably broad patent claims (based on the invention in question) for the Licensed Patents (including any interference or reexamination actions) for the University’s and MUSC FRD’s benefit. Within [***] of the Effective Date, the Licensee shall provide the University written notice of the name of the Licensee’s patent counsel and a copy of the engagement letter with patent counsel and shall inform the University before transferring the Licensed Patents to other counsel. Further, the Licensee shall assume primary responsibility for all patent activities, including all costs, associated with the perfection and maintenance of the

 

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Licensed Patents and shall provide the University with copies of all official documents and correspondence relating to the inventorship, prosecution, maintenance, and validity of the Licensed Patents prior to the filing of such documents. The Licensee shall provide sufficient notice and describe the proposed action to the University before taking any substantive actions in prosecuting the claims, and Licensee shall consider in good faith the University’s comments. To aid the Licensee in this process, the University shall provide information, execute and deliver documents and do other acts as Licensee may occasionally reasonably request. [***] The Licensee may not abandon prosecution of any U.S. or foreign patent application without first notifying the University of the Licensee’s intention and reason therefore at least [***] prior to any bar date and providing the University with reasonable opportunity to assume responsibility for prosecution and maintenance of such patents and patent applications.

9.2 On-Going Patent Prosecution. If the Licensee does not pursue patents in the U.S. or a foreign jurisdiction where patent protection may be available, the Licensee shall notify the University [***] prior to any patent prosecution bar date in the U.S. or foreign jurisdiction so that the University may prosecute patents in that jurisdiction if the University desires. If the University pursues such U.S. or foreign patent protection, then from that time forward all such patent applications and any patents arising therefrom will not be considered Licensed Patents under this Agreement and Licensee forfeits all rights under this Agreement to such patent applications and any patents arising therefrom. The University is solely responsible for all costs associated with those patent applications and patents it decides to pursue and maintain.

9.3 University’s Right to Resume Prosecution. If in the reasonable and good faith opinion of University’s patent counsel Licensee is endangering the University’s interest in the Licensed Patents based on the prosecution thereof, the University may provide the Licensee with written notice that the University wishes to resume control of the preparation, filing, prosecution, and maintenance of any patent applications or patents included in the Licensed Patents. If the University elects to resume these responsibilities, the Licensee shall cooperate fully with the University, its attorneys, and agents in the preparation, filing, prosecution, and maintenance of these patent applications or patents and shall provide the University with complete copies of all documents or other materials that the University deems necessary to undertake such responsibilities. University shall provide Licensee with copies of all official documents and correspondence relating to the inventorship, prosecution, maintenance, and validity of the Licensed Patents prior to the filing of such documents, and provide reasonable opportunity for Licensee to provide its comments. With respect to patent prosecution expenses incurred by the University after the University has resumed prosecution, the Licensee shall reimburse the University within [***] of receiving an invoice from the University. Notwithstanding the foregoing, Licensee may by written notice to the University omit any such patent application or patent from the Licensed Patents hereunder.

Article 10 Patent Enforcement

10.1 Notice of Infringement. The University and the Licensee shall inform the other party promptly in writing of any suspected infringement of the Licensed Patents by a third party. The parties shall include in the notice all evidence of infringement possessed by the suspecting party. Upon such notice and before proceeding with any action (e.g., cease and desist notice), the parties shall consult with each other.

 

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10.2 Licensee Suit. The Licensee has the first right to institute and prosecute alone a suit based on any suspected infringement. The University may be named as a party to any such suit, but only if:

 

  (a)

Licensee’s and the University’s respective legal counsel recommend that such action is necessary in their reasonable opinion to achieve standing;

 

  (b)

The University is not the first named party in the action; and

 

  (c)

The pleadings and any public statements about the action state that Licensee is pursuing the action and that Licensee has the right to join the University as a party.

If the Licensee (i) decides to institute suit or (ii) wishes to preserve its first right to institute and has developed a detailed plan to institute suit in the future, it shall provide written notice to the University within a commercially reasonable time, but no later than [***] after the date when a party receives notice of infringement. Licensee shall keep University reasonably apprised as to its plans related to instituting suit, and once a suit is instituted, of the status and progress of any litigation. [***].

10.3 Joint Suit. If the University and the Licensee agree to institute suit jointly, the parties to this Agreement shall bring the suit in both parties’ names, the out-of-pocket costs thereof will be borne equally, and any recovery or settlement will be [***]. The University and the Licensee will agree to the manner in which they will exercise control over such suit. Each party, at its option, may be represented by separate counsel of its own selection, the fees for which shall be paid by the party electing to retain its own counsel.

10.4 University Suit. If Licensee does not provide notice to University pursuant to Article 10.2 that it intends to initiate a suit or absent an agreement to institute a suit jointly pursuant to Article 10.3, the University may institute suit and may name Licensee for standing purposes. If the University decides to institute suit, it shall provide written notice to Licensee within [***] of the date when it receives notice that Licensee will not institute suit. If within [***] of such notice, Licensee does not notify the University in writing that it will jointly prosecute the suit. Licensee shall assign and hereby does assign to the University all rights, causes of action, and damages resulting from the alleged infringement. The University shall keep the Licensee reasonably apprised of the status and progress of any litigation. The University shall bear the entire cost of such litigation and [***].

Article 11 Warranties, Indemnifications, and Insurance

11.1 Representations and Warranties. The University represents and warrants to the best of the knowledge of its CU Innovations as of the Effective Date that: (a) it solely and exclusively owns or jointly owns with MUSC FRD the patents and applications included within the Licensed Patents and Diagnostic Patents as of the Effective Date; (b) it has the power and authority to grant the licenses provided for herein to the Licensee, and that it has not earlier granted, or assumed any obligation to grant, any rights in the Licensed Patents, Diagnostic Patents or the Licensed Information to any third party that would conflict with the rights granted to the Licensee herein; (c) CU Innovations has not granted any rights to any third party under the

 

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biological materials in which the University or MUSC has an ownership interest and that are identified as exclusively licensed as set forth in Appendix D; (d) the inter-institutional agreement between the University and MUSC FRD requires that MUSC FRD perform to the extent required hereunder (including with respect to the exclusive license grant); and (e) this Agreement constitutes the legal, valid and binding obligation of the University, enforceable against such University in accordance with its terms.

11.2 Disclaimer of Warranties.

 

  (a)

NEITHER THE UNIVERSITY NOR MUSC FRD MAKES AW REPRESENTATIONS, EXTENDS ANY WARRANTIES OF AW KIND, EITHER EXPRESS OR IMPLIED, NOR ASSUMES AW RESPONSIBILITIES WHATSOEVER WITH RESPECT TO USE, SALE, OR OTHER DISPOSITION BY LICENSEE OR AW SUBLICENSEE(S) OR VENDEES OR OTHER TRANSFEREES OF LICENSED PRODUCTS OR AW OTHER PRODUCTS OR PROCESSES INCORPORATING OR MADE BY USE OF THE LICENSED PATENTS, DIAGNOSTIC PATENTS OR LICENSED INFORMATION.

 

  (b)

THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OR SALE OF LICENSED PRODUCTS OR AW OTHER PRODUCTS OR PROCESSES INCORPORATING OR MADE BY USE OF THE LICENSED PATENTS. DIAGNOSTIC PATENTS OR LICENSED INFORMATION WILL NOT INFRINGE AW PATENT, COPYRIGHT. TRADEMARK, SERVICE MARK, OR OTHER RIGHTS.

 

  (c)

Nothing in this Agreement may be construed as

 

  (i)

a warranty or representation by the University or MUSC FRD as to the validity or scope of any of the rights included in the Licensed Patents or the Diagnostic Patents;

 

  (ii)

a warranty or representation that the Licensed Patents, Diagnostic Patents, Licensed Information, or anything made, used, sold or otherwise disposed of under this Agreement will or will not infringe patents, copyrights or other rights;

 

  (iii)

an obligation to furnish any know-how or services not agreed to in this Agreement, or

 

  (iv)

an obligation by the University or MUSC FRD to bring or prosecute actions or suits against third parties for infringement, or to provide any services other than those specified in this Agreement.

 

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11.3 Indemnification. The Licensee shall indemnify, defend, and hold University Indemnitees, MUSC FRD, and the MUSC Entities harmless from and against all liability, demands, damages, losses, and expenses (including attorney fees) for death, personal injury, illness, property damage, noncompliance with applicable laws and any other third party claim, proceeding, demand, expense and liability of any kind whatsoever in connection with or arising out of any of the following:

 

  (a)

The use by or on behalf of Licensee, any Sublicensees, directors, officers, employees, or third parties of any Licensed Patents, Diagnostic Patents, or Licensed Information;

 

  (b)

The design, manufacture, production, distribution, advertisement, consumption, sale, lease, sublicense or use of any Licensed Products or materials by Licensee, or other products or processes developed in connection with or arising out of the Licensed Patents, Diagnostic Patents, or Licensed Information; or

 

  (c)

Any breach by Licensee or Sublicensee of any obligation under this Agreement;

provided that Licensee has no obligation to indemnify MUSC FRD or any of the MUSC Entities to the extent liability arises from their medical use of the Licensed Patents reserved to MUSC and the MUSC Entities under Article 2.3(c).

11.4 Insurance. Prior to any Licensed Product being made, used, sold, distributed, imported or rendered, including for the purpose of obtaining regulatory approvals, by Licensee or a Sublicensee, and for a period of [***] after the Agreement expires or is terminated. Licensee shall, at its sole cost and expense, procure and maintain commercial general liability insurance in commercially reasonable and appropriate amounts for the Licensed Product being used, sold, distributed, imported or rendered. Licensee shall use commercially reasonable efforts to have the University and the University Indemnitees named as additional insureds. Such commercial general liability insurance must provide, without limitation: (i) product liability coverage before a Licensed Product is distributed to any third party for clinical or commercial use, or is used in the clinic or is used commercially, including for the purpose of obtaining regulatory approvals; (ii) broad form contractual liability coverage for Licensee’s indemnification under the Agreement; and (iii) coverage for litigation costs. Upon request by the University, Licensee shall provide the University with written evidence of such insurance. Additionally, Licensee shall provide the University with written notice of at least [***] prior to Licensee cancelling, not renewing, or materially changing such insurance. Licensee or any Sublicensee, once having more than [***] dollars in annual product sales, may elect to self-insure instead of the foregoing, provided that such self-insurance shall be adequate for the protection of itself and its officers, employees, and agents, and reasonably sufficient to ensure the performance of its obligations under Article 11.3 Indemnification.

Article 12 Duration, Conditions, Termination, and Conversion

12.1 Term. This Agreement is effective as of the Effective Date and continues in full force and effect until the end of the last Royalty Term unless earlier terminated pursuant to Article 12.2, 12.3, or 12.5. Upon expiration of the Royalty Term with respect to a Licensed Product in a particular country, the licenses granted in Article 2.1(b), (c), (d), (e) and (f) become non-exclusive, fully paid-up, royalty-free, perpetual and irrevocable for such Licensed Product in such country.

 

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12.2 Termination of Agreement by Licensee. The Licensee may terminate this Agreement at any time on 60 days prior written notice to the University, if the Licensee does all of the following:

 

  (a)

Pays all undisputed amounts due as well as all non-cancelable costs to the University through the termination date.

 

  (b)

Submits final payments as provided in Appendix A and a final report of the type described in Article 6 Reports, Records and Audits.

 

  (c)

Returns any confidential information provided to the Licensee by the University in connection with this Agreement.

 

  (d)

Suspends its use and sales of the Licensed Products; provided however, that subject to making the payments required by Article 3 and the reports required by Article 6, Licensee may, for a period of [***] after the effective date of such termination, sell all Licensed Products which may be in inventory; and provided further, that if the parties disagree on whether any product, service, or process constitutes a “Licensed Product” hereunder, then at the request of Licensee, the disputed matter shall be resolved in accordance with the dispute resolution process set forth in Article 13.9(a) through (c), and if decided against Licensee then (i) Licensee may revoke any termination under this Article 12.2, and (ii) [***].

12.3 Termination by University.

 

  (a)

The University may terminate this Agreement if Licensee does and fails to cure, within [***] of notice, any of the following:

 

  (i)

Is delinquent on any report or payment that is not in dispute;

 

  (ii)

Is in breach of the diligence obligations described in Appendix A.

 

  (iii)

Intentionally provides any false report, as determined between the parties pursuant to Article 13.9(a) through (c) of this Agreement, or is in breach of any other material provision of this Agreement.

 

  (iv)

Violates any laws or regulations of applicable governmental entities that have a material adverse effect on the

 

  (A)

University; or,

 

  (B)

Licensee’s ability to perform its obligations under this Agreement.

 

  (v)

Ceases to carry on development activities pertaining to the Licensed Products for a period of [***], except where such discontinuation is due to a force majeure event or other circumstances beyond Licensee’s reasonable control such as the action of regulatory authorities or a supply or manufacturing issue.

 

Exclusive License Agreement    Page 20 of 34    CU Case Numbers [***]


  (vi)

Licensee institutes a legal action challenging the validity of any Licensed Patent.

 

  (vii)

Asserts that its production, use, manufacture, rendering or sale of any product or process that the University reasonably believers is a Licensed Product does not infringe a Licensed Patent or was not developed using the Licensed Information; provided that if the parties disagree on the foregoing, then at the request of Licensee, the disputed matter shall be resolved in accordance with the dispute resolution process set forth in Article 13.9(a) through (c), and if decided against Licensee then Licensee will have the [***] cure period to maintain this Agreement.

 

  (viii)

Fails to maintain insurance as provided for in Article 11.

 

  (b)

Upon termination of this Agreement under this Article 12.3, Licensee shall suspend its use and sales of the Licensed Products.

12.4 Conversion to Non-Exclusive License. The University may at its reasonable discretion convert the exclusive license granted under Article 2.1(a) to a non-exclusive license if the Licensee does and fails to cure, within [***] of notice any of the following:

 

  (a)

Ceases to continue operating its material business.

 

  (b)

Does not use commercially reasonable efforts to develop the Licensed Patents including efforts consistent with the diligence milestones and obligations in Appendix A.

 

  (c)

After First Commercial Sale of the Licensed Products stops selling Licensed Product for two consecutive calendar quarters, except where a Sublicensee is selling Licensed Products or where such discontinuation of sales is due to a force majeure event or other circumstances beyond Licensee’s reasonable control such as the action of regulatory authorities or a supply or manufacturing issue.

12.5 12.5 Automatic Termination. This Agreement immediately terminates upon the Licensee’s dissolution, liquidation, Insolvency, or bankruptcy. In the case of a bankruptcy, this Agreement does NOT pass to a trustee in bankruptcy nor may the Agreement be held as an asset of said bankrupt.

Article 13 General

13.1 Assignment. This Agreement is binding upon and inures to the benefit of the respective successors and assigns of the parties to this Agreement.

 

  (a)

Assignment by Licensee. Subject to Articles 13.1 (b) and (c), the Licensee may assign this Agreement to a third party as part of a sale, regardless of whether such a sale occurs through an asset sale, stock sale, merger or other combination, or any other transfer of Licensee’s entire business.

 

Exclusive License Agreement    Page 21 of 34    CU Case Numbers [***]


  (b)

Conditions of Assignment. Within [***] of any such assignment : (i) the Licensee must provide the University with the new assignee’s contact information; and (ii) the new assignee must agree in writing with the University to be bound by this Agreement.

 

  (c)

Bankruptcy Petition. In the event the Licensee informs the University that the Licensee is considering filing a bankruptcy petition, the Licensee may assign this Agreement if the University determines in its sole discretion that the party has provided or can provide adequate assurance of future performance, including diligent development and sales, of the Licensed Patents.

 

  (d)

Any Other Assignment by Licensee. Any other attempt to assign this Agreement by the Licensee is null and void.

 

  13.2

General Notice.

 

  (a)

Notice under this Agreement is sufficient if given by registered mail, postage prepaid, and addressed to the party to receive such notice at the addresses given below, or such other address as may hereafter be designated by notice in writing. Notice is effective at the time of mailing.

The University shall mail all general notices to Licensee to the following address:

Admirx, Inc.

c/o [***]

[***]

Cambridge, MA 02139

Attn: [***]

The Licensee and Sublicensees shall mail all general notices to the University to the following address:

License Administrator, CU Case #[***]

CU Innovations

University of Colorado

[***]

Aurora, CO 80045

 

  (b)

Either party may change its address with written notice to the other party.

 

  (c)

Notwithstanding the other provisions in this Article 13, the University may email financial invoices to Licensee (i.e., accounting contact) to the following contact person:

Name: David Grayzel

Email: [***]

 

Exclusive License Agreement    Page 22 of 34    CU Case Numbers [***]


13.3 Invalidation Notice. Licensee shall provide written notice to the University at least [***] prior to bringing an action seeking to invalidate any Licensed Patent or a declaration of non-infringement. The Licensee shall include in such written notice an identification of all prior art it believes invalidates any claim of the patent.

13.4 Use of Names and Marks.

 

  (a)

The Licensee shall not identify the University in any promotional advertising, press releases, sales literature or other promotional materials to be disseminated to the public or any portion thereof without the University’s prior written consent in each case, except that the Licensee may state that it has a license for the Licensed Patents from the University. The University may state that it has a license for the Licensed Patents with the Licensee. The Licensee further shall not use the name of the University or any University faculty member, inventor, employee or student or any trademark, service mark, trade name, copyright or symbol of the University, without the prior written consent of the University, entity or person whose name is sought to be used.

 

  (b)

The Licensee shall not identify MUSC, MUSC FRD, or any MUSC Entity in any promotional advertising, press releases, sales literature or other promotional materials to be disseminated to the public or any portion thereof without the prior written consent of MUSC, MUSC FRD, or any MUSC Entity, as applicable, in each case. The Licensee further shall not use the name of MUSC, MUSC FRD, any MUSC Entity or any MUSC faculty member, inventor, employee or student or any trademark, service mark, trade name, copyright or symbol of MUSC, MLTSC FRD or any MUSC Entity, without the prior written consent of the entity or person whose name is sought to be used.

13.5 Marking. The Licensee shall cause Licensed Products sold under this Agreement to be marked with the notice of the patent numbers or patent pending, as may be appropriate.

13.6 University Rules and Regulations. The Licensee acknowledges that University employees who are engaged by the Licensee, whether as consultants, employees, or otherwise, or who possess a material financial interest in the

Licensee, are subject to the University’s rule regarding outside activities and financial interests as set forth in the University’s intellectual property policy and related policies regarding conflicts of interest and outside consulting, as may be amended from time to time. Any term or condition of an agreement between the Licensee and a University employee that seeks to vary or override such employee’s obligations to the University may not be enforced against such personnel or the University without the express written consent of the Principal Technology Transfer Officer as well as University Physicians, Inc., as applicable.

13.7 Compliance with the Law. The Licensee shall comply with all commercially material local, state, federal, and international laws and regulations relating to its obligations under this Agreement regarding the development, manufacture, use, and sale of Licensed Products.

 

Exclusive License Agreement    Page 23 of 34    CU Case Numbers [***]


13.8 Choice of Law. This Agreement is governed by and will be construed in accordance with the laws of Colorado.

13.9 Dispute Resolution. In the event of any dispute arising out of or relating to this Agreement, the affected party shall promptly provide notice to the other party, and the parties shall attempt in good faith to resolve the matter. Any termination of this Agreement (with a corresponding cure period) may be tolled by the non-terminating party until the completion of this Article 13.9(a) through (c).

 

  (a)

Any disputes not so resolved shall be referred to the Principal Technology Transfer Officer for the University and to Licensee’s Senior Executives with settlement authority, who shall meet at a mutually acceptable time and location within [***] of the Notice Date and shall attempt in good faith to negotiate a settlement.

 

  (b)

If the [***] for the University and [***] fail to meet within [***] after the Notice Date under Article 13.9(b) or such later date as may be agreed upon by the parties, or if the matter remains unresolved for a period of [***] after the Notice Date, then, upon request of either party, the parties shall appoint a mutually acceptable mediator to facilitate resolution of the dispute. The parties shall discuss their differences in good faith and shall attempt in good faith, with facilitation by the mediator, to reach a mutually acceptable resolution of the dispute within [***] after the mediator’s appointment or such later date as may be agreed upon by the parties.

 

  (c)

Neither party shall commence any legal action with respect to any dispute arising out of or relating to this Agreement unless and until the parties have exhausted the procedures set forth in Articles 13.9 (a) and (b). In such event, in connection with any legal action arising out of or relating to this Agreement, each party hereby irrevocably submits to the jurisdiction of a court of competent jurisdiction in Denver, Colorado, and, by execution and delivery of this Agreement, (i) accepts, generally and unconditionally, the jurisdiction of such court and any related appellate court, and (ii) irrevocably waives any objection it may now or hereafter have as to the venue of any such suit, action or proceeding brought in the court or that the court is an inconvenient forum.

13.10 Merger and Modification of Agreement. The terms and provisions contained in this Agreement, and all Appendices hereto, constitute the entire agreement between the parties and supersede all previous communications, representations, agreements or understandings, either oral or written, between the parties with respect to the subject matter, and no agreement or understanding varying or extending this Agreement will be binding upon either party to this Agreement, unless in a written amendment signed by duly authorized officers or representatives of the respective parties, and the provisions of this Agreement not specifically amended thereby remain in full force and effect according to their terms.

 

Exclusive License Agreement    Page 24 of 34    CU Case Numbers [***]


13.11 Severability. The provisions and clauses of this Agreement are severable, and in the event that any provision or clause is determined to be invalid or unenforceable under any controlling body of the law, such invalidity or unenforceability will not in any way affect the validity or enforce ability of the remaining provisions and clauses.

13.12 Scope. This Agreement does not establish a joint venture, agency or partnership between the parties, nor create an employer—employee relationship.

13.13 Preservation of Immunity. Nothing in this Agreement is intended or should be construed as a waiver, either express or implied, of any of the immunities, rights, benefits, defenses or protections provided to the University under governmental or sovereign immunity laws from time to time applicable to the University, including, without limitation, the Colorado Governmental Immunity Act (C.R.S. § 24-10-101, et seq.) and the Eleventh Amendment to the United States Constitution.

13.14 Headings. The headings are included for convenience only and may not be used to construe this Agreement.

13.15 Survival. The provisions of Articles 3 Economic Consideration; 6 Reports, Records, and Audits; 7 Confidential Information; 11 Warranties, Indemnifications, and Insurance; 12 Duration, Conditions, Termination, and Conversion; 13.1(a) Assignment by Licensee: 13.4 Use of Names and Marks; 13.8 Choice of Law; 13.9 Dispute Resolution; 13.13 Preservation of Immunity; 13.15 Survival; and any other provision of this Agreement that by its nature is intended to survive, will survive any termination or expiration of this Agreement.

* * *

 

Exclusive License Agreement    Page 25 of 34    CU Case Numbers [***]


To evidence the parties’ agreement to this Agreement, the parties have executed it in duplicate and delivered it on the date stated in the Preamble.

 

UNIVERSITY
By:   /s/ Kimberly Muller

Kimberly Muller, Managing Director

CU Innovations

University of Colorado

[***]

Aurora, CO 80045

 

LICENSEE
By:   /s/ David Grazel
Name: David Grayzel
Title: President and Treasurer

 

[Signature Page to Exclusive License Agreement]


APPENDIX A: SPECIFIC TERMS AND CONDITIONS

 

1.

Patents:

 

  (a)

The Licensed Patents are as follows:

 

[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]

 

  (i)

Field of Use: all fields.

 

  (ii)

Territory: Worldwide.

 

  (b)

The Diagnostic Patents are as follows:

 

Internal ID

  

Country

  

Serial No.

  

File Date

  

Title

[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]

 

Exclusive License Agreement    Page 27 of 34    CU Case Numbers [***]


[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]

 

2.

Financial Conditions:

 

  (a)

Patent Fees and Costs. The Licensee shall reimburse the University for patenting expenses incurred by the University. For expenses incurred by the University prior to the Effective Date, the Licensee shall pay the University in two installments as follows:

 

  (i)

The initial patent reimbursement payment of [***] is due within [***] of the Effective Date.

 

  (ii)

The second patent reimbursement payment of [***] if paid on or before [***] or [***] if paid after [***], is due no later than [***].

With respect to expenses incurred by the University after the Effective Date plus any other unreimbursed patent expenses, the Licensee shall reimburse the University within [***] of receiving an invoice from the University.

 

  (b)

Milestone Fees: For each of the first three Licensed Products, Licensee shall pay University Milestone fees of

(i) [***]

 

  (c)

Royalty on Net Sales. Licensee shall pay the University the following royalties on Net Sales, on a Licensed Product-by-Licensed Product basis:

 

  (i)

With respect to sales of each of the Licensed Products as defined in Article l(l)(i) of this Agreement : [***] of Net Sales up to cumulative Net Sales of [***] and [***] of Net Sales on cumulative Net Sales greater than [***].

 

  (ii)

With respect to sales of each of the Licensed Products as defined in Article l(l)(ii) or (iii), the making, use, offer for sale, sale, importation or rendering of which would not infringe one or more Valid Claims in the country in which it is made, used, sold, offered for sale, imported, or rendered: [***].

 

  (d)

Royalty on Sublicense Income. The Licensee shall pay the University an earned royalty at 15 percent of the Sublicense Income.

 

Exclusive License Agreement    Page 28 of 34    CU Case Numbers [***]


  (e)

Generic Products. In the event that during the Royalty Term for a Licensed Product in a country in the Territory, unit sales of all Generic Products in the relevant country in a calendar quarter equal or exceed [***] of the sum of unit sales of such Licensed Product, then, commencing upon the following calendar quarter and for so long as the sales of the Generic Product in such country in a calendar quarter continue to equal or exceed [***] of the sum of unit sales of such Licensed Products, the Net Sales royalty rates set forth in Section 2(c) of Appendix A, above, with respect to Net Sales in such country, will be reduced by [***].

 

  (f)

Royalty Stacking. In the event Licensee is of the reasonable view that it must enter into a license with a third party and agrees to pay a royalty thereunder in order to practice the Licensed Patents or to develop, make, use or sell a Licensed Product, then the Net Sales royalty applicable to such Licensed Product and owed to the University for the reporting period in which the payment is made may be reduced by [***] the amount of such third party royalty; provided, however, that the royalty paid to the University by Licensee may not be reduced by more than [***] in any reporting period.

 

  (g)

Minimum Net Sales Royalty Payment. In no event may the Net Sales royalty payments due in any reporting period be reduced by more than [***] of the unadjusted royalty payment that would be due in the absence of royalty stacking reductions, Combination Products reductions, and Generic Product reductions.

 

  (h)

Timing or Reporting and Payment Obligations. The Licensee shall

 

  (i)

prepare a [***] Royalty Report pursuant to Article 6 Reports. Records and Audits and Appendix C, Form of Royalty Report; and

 

  (ii)

submit the earned royalty payment, if any

within [***] after the end of [***].

 

  (i)

No Multiple Royalties. No multiple royalties are payable in the event any Licensed Products are covered by more than one of the Licensed Patents.

 

  (j)

Interest. Licensee shall pay past payments including interest at either the rate of [***], whichever is less.

 

  (k)

Payments After License Termination. After the Agreement terminates, the Licensee shall continue to submit earned royalty payments and reports required by Article 6 of this Agreement, until all Licensed Products made or imported under this Agreement have been sold and until all sublicense payments have been received by Licensee.

 

  (l)

Tax-exempt. All payments due under this Agreement shall be made without deduction for taxes, assessments, or other charges of any kind that may be imposed on the University by any government outside of the United States or any political subdivision of such government with respect to any amounts payable to the University pursuant to this Agreement. All such taxes, assessments, or other charges shall be assumed by the Licensee.

 

Exclusive License Agreement    Page 29 of 34    CU Case Numbers [***]


  (m)

Payments. The Licensee shall make or cause its Sublicensee to make all payments to the University payable to “The Regents of the University of Colorado’’ and mail them to the following address:

CU Innovations

University of Colorado

[***]

 

3.

Licensee Due Diligence Milestones and Obligations

 

  (a)

Due Diligence Milestones. The Licensee shall use, or shall cause its Sublicensee(s) to use, commercially reasonable efforts to develop, manufacture, sublicense, market and sell one or more Licensed Products in the Fields of Use and the Territory in accordance with the milestones defined here.

[***]

 

  (b)

Mandatory Sublicensing. [***]

 

4.

Miscellaneous Terms:

 

  (a)

[***]

 

Exclusive License Agreement    Page 30 of 34    CU Case Numbers [***]


APPENDIX B: DILIGENCE REPORT

 

1.

Diligence Reports General: Pursuant to Article 6 of this Agreement, the Licensee is obligated to submit Diligence Reports. The Licensee shall submit the following:

 

  (a)

A development plan initiated within [***] of securing the exclusive license agreement that covers a period of [***] from delivery.

 

  (b)

An annual Diligence Report within [***] and mark it as confidential.

 

2.

Diligence Report Details The Licensee shall include the following items in the Diligence Report:

 

  (a)

Development Report (4-8 paragraphs)

[***]

 

  (b)

Future development activities (4-8 paragraphs)

[***]

 

  (c)

Changes to initial development plan (2-4 paragraphs)

[***]

 

  (d)

Additional items to be provided:

[***]

 

Exclusive License Agreement    Page 31 of 34    CU Case Numbers [***]


APPENDIX C: FORM OF ROYALTY REPORT

[Intentionally Omitted]

 

Exclusive License Agreement    Page 32 of 34    CU Case Numbers [***]


Appendix D

[Intentionally Omitted]

 

Exclusive License Agreement    Page 33 of 34    CU Case Numbers [***]


APPENDIX E

FORM OF MATERIALS TRANSFER AGREEMENT

[Intentionally Omitted]

 

Exclusive License Agreement    Page 34 of 34    CU Case Numbers [***]

Exhibit 10.40

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

FIRST AMENDMENT TO THE EXCLUSIVE LICENSE AGREEMENT

This First Amendment to the Exclusive License Agreement (the “First Amendment”) is made and entered into this 8th day of February 2018 (“First Amendment Effective Date”) by and between the Regents of the University of Colorado, a body corporate, for and on behalf of the University of Colorado Denver (“University”), and AdMiRx, Inc. a Delaware corporation (“Licensee”).

Background

 

  A.

The parties entered into an Exclusive License Agreement on August 9, 2017, (the “Agreement”).

 

  B.

University and MUSC Foundation for Research Development (“MUSC FRD”) are co-owners of the Licensed Group II Patents (“Licensed Group II Patents”) has the meaning assigned to it in Article 1) related to University Case Number [***], and MUSC FRD has entered into an inter-institutional agreement with University whereby MUSC FRD has authorized University to license and administer MUSC FRD’s interest in such Licensed Group II Patents, on behalf of the Medical University of South Carolina (“MUSC”).

 

  C.

The Licensee desires to license the Licensed Group II Patents for the purpose of developing and commercializing products covered by the Licensed Group II Patents

 

  D.

The parties wish to amend the Agreement to include a grant of rights to the Licensed Group II Patents.

Accordingly, the parties agree as follows:

Article 1 Amendment

1.1    Any capitalized terms not defined herein have the same meaning as set forth in the Agreement.

1.2    Article 1.1(m) of the Agreement is hereby revised to read in its entirety as follows:

(m)    “Licensed Patents” means collectively, the Licensed Group I Patents and the Licensed Group II Patents.

1.3    Article 1.1 of the Agreement is hereby amended by the addition of the following:

(gg)    “Licensed Group I Patents” means:


  (i)

The United States and foreign patent(s) or nonprovisional patent application(s) or provisional patent applications listed in Appendix A as the Licensed Group I Patents, the patents issued therefrom, including any reissues, reexaminations, extensions of such patents, and any registrations, supplementary protection certificates and renewals of any such patents or patent applications, and all rights and priorities in any of the foregoing.

 

  (ii)

All divisionals and continuations that take priority from those patents and patent applications listed in Appendix A as the Licensed Group I Patents, and the patents issued therefrom, including any reissues, reexaminations, extensions of such patents, and any registrations, supplementary protection certificates and renewals of any such patents or patent applications, and all rights and priorities in any of the foregoing.

 

  (iii)

Claims of any continuations-in-part applications that take priority from those patents and patent applications listed in Appendix A and resulting patents that are directed to subject matter described in the patents and patent applications listed in Appendix A as the Licensed Group I Patents, registrations, supplementary protection certificates and renewals of any such patents or patent applications, and all rights and priorities in any of the foregoing.

(hh)    “Licensed Group II Patents” means:

 

  (i)

The United States and foreign patent(s) or nonprovisional patent application(s) or provisional patent applications listed in Appendix A as the Licensed Group II Patents, the patents issued therefrom, including any reissues, reexaminations, extensions of such patents, and any registrations, supplementary protection certificates and renewals of any such patents or patent applications, and all rights and priorities in any of the foregoing.

 

  (ii)

All divisionals and continuations that take priority from those patents and patent applications listed in Appendix A as the Licensed Group II Patents, and the patents issued therefrom, including any reissues, reexaminations, extensions of such patents, and any registrations, supplementary protection certificates and renewals of any such patents or patent applications, and all rights and priorities in any of the foregoing.

 

  (iii)

Claims of any continuations-in-part applications that take priority from those patents and patent applications listed in Appendix A and resulting patents that are directed to subject matter described in the patents and patent applications listed in Appendix A as the Licensed Group II Patents, registrations, supplementary protection certificates and renewals of any such patents or patent applications, and all rights and priorities in any of the foregoing.

 

First Amendment to Exclusive License Agreement    Page 2 of 6    CU Case No. [***]


1.4    Article 2.1 of the Agreement is hereby revised to read in its entirety as follows:

2.1    License. Subject to the terms and conditions of this Agreement, the University hereby grants to the Licensee

 

  (a)

an exclusive (as to the University and MUSC FRD), sublicensable (through multiple tiers) license to the Licensed Group I Patents, and

 

  (b)

an exclusive (as to the University), sublicensable (through multiple tiers) license, subject to any pre-existing third party rights, to the biological materials, reagents, processes and information in which the University has an ownership interest and identified as being exclusively licensed as set forth in Appendix D, and

 

  (c)

a non-exclusive, sublicensable (through multiple tiers) license to the biological materials, reagents, processes and information in which the University has an ownership interest and identified as being non- exclusively licensed as set forth in Appendix D, and

 

  (d)

an exclusive (as to MUSC-FRD), sublicensable (through multiple tiers) license, subject to any pre-existing third party rights, to the biological materials, reagents, processes and information in which MUSC-FRD has an ownership interest and identified as being exclusively licensed as set forth in Appendix D, and

 

  (e)

a non-exclusive, sublicensable (through multiple tiers) license to the biological materials, reagents, processes and information in which MUSC-FRD has an ownership interest and identified as being non- exclusively licensed as set forth in Appendix D, and

 

  (f)

a non-exclusive, sublicensable (through multiple tiers) license to the Licensed Information (other than the biological materials, reagents, processes and information set forth in Appendix D), and

 

  (g)

a non-exclusive, sublicensable (through multiple tiers) license to the Licensed Group II Patents,

to research, have researched, develop, have developed, commercialize, have commercialized, make, have made, use, have used, import, have imported, offer to sell, have offered to sell, sell, Have Sold and practice the Licensed Products in the Field(s) of Use and the Territory, “Have Sold” means the sale of Licensed Products by distributors and other agents for and on behalf of the Licensee.

1.5    Appendix A, Article 1(a) of the Agreement is hereby revised to read in its entirety as follows:

(a)    The Licensed Patents are as follows:

 

First Amendment to Exclusive License Agreement    Page 3 of 6    CU Case No. [***]


  (i)

Licensed Group I Patents:

 

[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]

 

  (1)

Field of Use: all fields.

 

  (2)

Territory: Worldwide.

 

  (ii)

Licensed Group II Patents:

 

[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]
[***]   [***]   [***]    [***]    [***]

 

  (1)

Field of Use: all fields.

 

  (2)

Territory: Worldwide.

1.6    Section 2(a) Royalty on Sublicense Income of Appendix A to the Agreement is hereby renumbered as Section 2(cc) Royalty on Sublicense Income.

1.7    A new subsection (m) is added to Section 2 of Appendix A to the Agreement as follows:

(m)    Payments to University Involving Licensed Group II Patents.

 

First Amendment to Exclusive License Agreement    Page 4 of 6    CU Case No. [***]


  (i)

Under Sections 2(b) Milestone Fees, 2(c) Royalty on Net Sales, and 2(cc) Royalty’ on Sublicense Income of this Appendix A, if the Licensed Product that is the subject of the payment is solely based on the Licensed Group II Patents (in reference to the Licensed Product definition) and not the Licensed Group I Patents, then the amounts otherwise payable to the University with respect to such Licensed Product under Sections 2(b) Milestone Fees, 2(c) Royalty on Net Sales, and 2(cc) Royalty on Sublicense Income of this Appendix A are reduced by [***], and the relevant royalty rates for a Licensed Product solely based on the Licensed Group II Patents for purposes of Sections 2(d) Generic Products, 2(e) Royalty Stacking and Section 2(f) Minimum Net Sales Royalty Payment are the royalties set forth in this Section 2(ni)(i) (that is, the royalty’ rate percentages are [***]).

 

  (ii)

In the event a third party who has a license under the Licensed Group II Patents, but who is not an Affiliate or a Sublicensee, begins commercial sales of a product based on the Licensed Group II Patents (in reference to the Licensed Product definition), upon written notice from Licensee to the University of such commercial sales, then thereafter under Sections 2(b) Milestone Fees, 2(c) Royalty on Net Sales, and 2(cc) Royalty on Sublicense Income of this Appendix A, if the Licensed Product that is the subject of the payment is solely based on the Licensed Group II Patents (in reference to the Licensed Product definition) and not the Licensed Group I Patents, then the amounts otherwise payable to the University with respect to such Licensed Product under Sections 2(b) Milestone Fees, 2(c) Royalty on Net Sales, and 2(cc) Royalty on Sublicense Income of this Appendix A will be reduced by [***], and the relevant royalty rates for a Licensed Product solely based on the Licensed Group II Patents for purposes of Sections 2(d) Generic Products, 2(e) Royalty Stacking and Section 2(f) Minimum Net Sales Royalty’ Payment are the royalties set forth in this Section 2(ni)(ii) (that is, the royalty rate percentages are reduced by [***]).

Article 2 Financial Consideration

2.1    Patent Fees and Costs for Licensed Group II Patents. The Licensee shall reimburse the University for patenting expenses incurred by the University with respect to the Licensed Group II Patents as provided in this Article 2.1. For expenses incurred by the University prior to the First Amendment Effective Date with respect to the Licensed Group II Patents, the Licensee shall pay the University [***] within [***] of the First Amendment Effective Date and [***] on or before [***]. With respect to expenses incurred by the University after the First Amendment Effective Date with respect to the Licensed Group II Patents, the Licensee shall reimburse the University within [***] of receiving an invoice from the University; provided that if there is another licensee who is granted commercial rights under the Licensed Group II Patents pursuant to an agreement entered into by the University after the First Amendment Effective Date, Licensee and each such other commercial licensee will share on a pro rata basis (based on the number of licensees) all patent expenses related thereto incurred after

 

First Amendment to Exclusive License Agreement    Page 5 of 6    CU Case No. [***]


the effective date of the relevant other license agreement., For clarity the patent cost reimbursement terms of Appendix A, Section 2(a) Patent Fees and Costs of the Agreement will not apply to the Licensed Group II Patents.

Article 3 Miscellaneous

3.1    Except as expressly amended by this First Amendment, all provisions of the Agreement remain in full force and effect.

3.2    This First Amendment shall be governed by and construed in accordance with the laws of the State of Colorado.

3.3    This First Amendment together with the Agreement contains the entire understanding and agreement between the parties respecting the subject matter thereof and supersedes all prior understandings and agreements.

3.4    The provisions and clauses of this First Amendment are severable, and in the event that any provision or clause is determined to be invalid or unenforceable under any controlling body of the law, such invalidity or unenforceability will not in any way affect the validity or enforceability of the remaining provisions and clauses hereof.

To evidence the parties’ agreement to this First Amendment, the parties have executed it in duplicate and delivered it on the First Amendment Effective Date.

 

University      Licensee

/s/ James Roberts

    

/s/ David Grayzel

Name:  James Roberts      Name:  David Grayzel, MD

Title:    Director of Licensing

            CU Innovations

     Title:    Chairman, Admirx

 

First Amendment to Exclusive License Agreement    Page 6 of 6    CU Case No. [***]

Exhibit 10.41

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

SECOND AMENDMENT TO THE EXCLUSIVE LICENSE AGREEMENT

This Second Amendment to the Exclusive License Agreement (the “Second Amendment”) is made and entered into this 27th day of September 2018 (the “Second Amendment Effective Date”) by and between the Regents of the University of Colorado, a body corporate, for and on behalf of the University of Colorado Denver at the Anschutz Medical Campus (“University”), and AdMiRx, Inc. a Delaware corporation (“Licensee”).

Background

 

  A.

The parties entered into an Exclusive License Agreement on August 9,2017, as amended by the First Amendment to the Exclusive License Agreement on February 8,2017(the “Agreement”).

 

  B.

University is willing to agree not to grant any further non-exclusive licenses under the Licensed Group II Patents as of the Second Amendment Effective Date.

 

  C.

The parties wish to include additional obligations on the part of University and MUSC-FRD related to the transfer of those biological materials that are exclusively licensed to Licensee to under its reservation of rights under Article 2.3(a) of the Agreement.

Accordingly, the parties agree as follows:

Article 1 Amendment

1.1    Any capitalized terms not defined herein have the same meaning as set forth in the Agreement.

1.2    ‘ Article 2.1(g) of the Agreement is hereby revised to read in its entirety as follows:

 

  (g)

a non-exclusive, sublicensable (through multiple tiers) license to the Licensed Group II Patents; provided that University and MUSC-FRD shall not grant any further licenses to the Licensed Group II Patents to any third party,

1.3    Article 2.3(a) of the Agreement is hereby revised to read in its entirety as follows:

 

  (a)

The licenses granted under Article 2.1(a) (b), (d) and (g) are expressly made subject to the University’s reservation, on behalf of itself, MUSC, future not-for-profit employers of the inventors of the Licensed Patents, and all other not-for-profit academic and research institutions, of the right to practice the Licensed Patents and use the biological materials, reagents,

 

Second Amendment to Exclusive License Agreement    1 of 4    CU Case No. [***]


processes and information listed on Appendix D for educational, research, non-clinical, or other non-commercial purposes (but in no case when sponsored by any for-profit entity). Notwithstanding the foregoing, University, MUSC-FRD, and MUSC shall not transfer any biological materials set forth on Appendix D as being exclusively licensed to Licensee to any third party without the consent of Licensee, provided that the University, MUSC-FRD, and MUSC may transfer such biological materials set forth on Appendix D to any not-for-profit academic and research institution upon advance written notice to Licensee and under a materials transfer agreement approved by Licensee and attached hereto as Appendix E. If such not-for-profit institution requests modifications to the material transfer agreement in Appendix E, University or MUSC shall submit the modified agreement to Licensee for approval. If Licensee does not respond to University or MUSC’s request for approval within [***] of its receipt of the modified agreement from University or MUSC, University or MUSC is free to transfer the materials to the not-for-profit institution under the modified agreement.

Notwithstanding the foregoing paragraph, prior to delivery of such material to a not-for-profit academic or research institution, University, MUSC-FRD or MUSC, as applicable, shall notify Licensee of such request, and Licensee may, but is not obligated to, provide such material to University, MUSC-FRD or MUSC, as the case may be, for delivery to the not-for-profit academic or research institution. If Licensee elects to provide such material, Licensee shall so notify University, MUSC-FRD or MUSC, as the case may be, within [***] of its receipt of the notice from University, MUSC-FRD or MUSC, as the case may be, and University, MUSC-FRD or MUSC, as the case may be, shall not deliver any material to the not-for-profit academic or research institution that it has not received from Licensee for such purpose. If Licensee does not notify University, MUSC-FRD or MUSC, as the case may be, within the [***] period that it will supply the material, University, MUSC-FRD or MUSC, as the case may be, is free to provide the material in its possession.

In the event that the University enters into a materials transfer agreement with a not-for-profit academic or research institution under this Article 2.3(a) in the form attached as Appendix E, and the not-for-profit academic or research institution provides notice to the University, MUSC-FRD or MUSC, as the case may be, of an invention in accordance with the terms of the materials transfer agreement, the University, MUSC-FRD or MUSC, as the case may be, shall promptly provide such notice to Licensee.

1.4    Article 2.3(c) of the Agreement is hereby revised to read in its entirety as follows:

 

  (c)

The University retains on behalf of MUSC and the MUSC Entities, the use for medical care purposes of the Licensed Patents related to [***], the

 

Second Amendment to Exclusive License Agreement    2 of 4    CU Case No. [***]


Licensed Group II Patents and the biological materials, reagents, processes and information set forth on Appendix D as being exclusively licensed to Licensee, provided that the rights extended for medical care purposes will only apply to circumstances in which MUSC has determined that there is a clinical need for such exercise of the rights, and such rights are limited to patient care provided directly by care providers at the MUSC Entities. “MUSC Entities” means MUSC, MUSC Physicians, the Medical University Hospital Authority, the MUSC Foundation and all entities with MUSC which are under the control of the Board of Trustees of MUSC.

Article 2 Miscellaneous

2.1    Except as expressly amended by this Second Amendment, all provisions of the Agreement remain in full force and effect.

2.2    This Second Amendment shall be governed by and construed in accordance with the laws of the State of Colorado.

2.3    This Second Amendment together with the Agreement contains the entire understanding and agreement between the parties respecting the subject matter thereof and supersedes all prior understandings and agreements.

2.4    The provisions and clauses of this Second Amendment are severable, and in the event that any provision or clause is determined to be invalid or unenforceable under any controlling body of the law, such invalidity or unenforceability will not in any way affect the validity or enforceability of the remaining provisions and clauses hereof.

2.5    This Agreement may be executed in counterparts, which taken together constitute a single legal document. A facsimile or portable document format (“.pdf’) copy of this Agreement, including the signature pages, is hereby deemed an original.

[Remainder of Page Intentionally Blank, Signature Page Follows]

 

Second Amendment to Exclusive License Agreement    3 of 4    CU Case No. [***]


To evidence the parties’ agreement to this Second Amendment, the parties have executed it in duplicate and delivered it on the Second Amendment Effective Date.

 

University   Licensee

/s/ Jim Roberts

 

/s/ Shelia Violette

Name: Jim Roberts

Title: Director, Licensing

 

Name: Shelia Violette

Title: Chief Scientific Officer

September 27, 2018

 

October 1, 2018

Date   Date

 

Second Amendment to Exclusive License Agreement    4 of 4    CU Case No. [***]

Exhibit 10.42

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

THIRD AMENDMENT TO THE EXCLUSIVE LICENSE AGREEMENT

This Third Amendment to the Exclusive License Agreement (the “Third Amendment”) is made and entered into this 9 th day of April 2019 (the “Third Amendment Effective Date”) by and between the Regents of the University of Colorado, a body corporate, for and on behalf of the University of Colorado Denver at the Anschutz Medical Campus (“University”), and AdMiRx, Inc. a Delaware corporation (“Licensee”).

Background

 

  A.

The parties entered into an Exclusive License Agreement on August 9, 2017, as amended by the First Amendment to the Exclusive License Agreement on February 8, 2017 and by the Second Amendment to the Exclusive License Agreement on September 27, 2018 (the “Agreement”).

 

  B.

MUSC Foundation for Research Development (“MUSC FRD”) is the owner of the patents related to University Case Numbers [***] (“MUSC FRD Patents”), and MUSC FRD has entered into an inter-institutional agreement with University whereby MUSC FRD has authorized University to license and administer MUSC FRD’s interest in such patents on behalf of the Medical University of South Carolina (“MUSC”).

 

  C.

The Licensee desires to license the MUSC FRD Patents for the purpose of developing and commercializing products covered by the MUSC FRD Patents.

 

  D.

The parties wish to amend the Agreement to include the MUSC FRD Patents.

Accordingly, the parties agree as follows:

Article 1 Amendment

1.1    Any capitalized terms not defined herein have the same meaning as set forth in the Agreement.

1.2    Appendix A, Article l(a)(i) of the Agreement is hereby revised to read in its entirety as follows:

 

  (i)

Licensed Group I Patents: [***]

 

  (1)

Field of Use: all fields.

 

  (2)

Territory: Worldwide.

 

Third Amendment to Exclusive License Agreement    1 of 3    CU Case No. [***]


Article 2 Miscellaneous

2.1    Except as expressly amended by this Third Amendment, all provisions of the Agreement remain in full force and effect.

2.2    This Third Amendment shall be governed by and construed in accordance with the laws of the State of Colorado.

2.3    This Third Amendment together with the Agreement contains the entire understanding and agreement between the parties respecting the subject matter thereof and supersedes all prior understandings and agreements.

2.4    The provisions and clauses of this Third Amendment are severable, and in the event that any provision or clause is determined to be invalid or unenforceable under any controlling body of the law, such invalidity or unenforceability will not in any way affect the validity or enforceability of the remaining provisions and clauses hereof.

2.5    . This Third Amendment may be executed in counterparts, which taken together constitute a single legal document. A facsimile or portable document format (“.pdf’) copy of this Third Amendment, including the signature pages, is hereby deemed an original.

[Remainder of Page Intentionally Blank, Signature Page Follows]

 

Third Amendment to Exclusive License Agreement    2 of 3    CU Case No. [***]


To evidence the parties’ agreement to this Third Amendment, the parties have executed it in duplicate and delivered it on the Third Amendment Effective Date.

 

University      Licensee

/s/ Jim Roberts

Name: Jim Roberts
Title: Director, Licensing

    

/s/ David Grayzel

Name: David Grayzel
Title: Chairman

April 11, 2019

Date

    

April 9, 2019

Date

 

Third Amendment to Exclusive License Agreement    3 of 3    CU Case No. [***]

Exhibit 10.43

 

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

LICENSE AGREEMENT

between

ADMIRX INC.

and

BRISTOL-MYERS SQUIBB COMPANY

 

 


LICENSE AGREEMENT

THIS LICENSE AGREEMENT (this “Agreement”) is made and entered into as of the date last signed by a party below (the “Effective Date”), by and between Bristol-Myers Squibb Company, a Delaware corporation, headquartered at 430 E. 29th Street, 14th Floor, New York, New York 10016 (“BMS”), and AdMIRx Inc., a Delaware corporation, with its principal offices at LabCentral, 700 Main Street, North, Cambridge, MA 02139 (“Company”). BMS and Company are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”

RECITALS

WHEREAS, BMS and its Affiliates Control (as defined below) certain intellectual property rights with respect to the Licensed Compounds (as defined below); and

WHEREAS, Company desires to obtain from BMS the licenses set forth herein, and BMS desires to grant such licenses to Company, all on the terms and conditions set forth in this Agreement;

NOW, THEREFORE in consideration of the foregoing and the mutual agreements set forth below, the Parties agree as follows:

ARTICLE 1

DEFINITIONS

The terms in this Agreement with initial letters capitalized, whether used in the singular or the plural, shall have the meaning set forth below or, if not listed below, the meaning designated in places throughout this Agreement.

1.1    “Abbreviated Application” means (a) an application submitted to the FDA under subsection (k) of Section 351 of the PHSA, (b) an abbreviated New Drug Application submitted to the FDA under Section 505(j) of the FD&C ACT (21 USC 355(j)), or (c) any analogous application to those applications set forth in clauses (a) or (b) submitted to a Regulatory Authority in the United States or in another country in the world.

1.2    “Act” means the United States Food, Drug and Cosmetic Act, as amended.

1.3    “Affiliate” of a Person means any other Person which (directly or indirectly) is controlled by, controls or is under common control with such Person. For the purposes of this definition, the term “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”) as used with respect to a Person, shall mean the possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of such Person, whether through the ownership of voting securities, by contract or otherwise, and “control” shall be presumed to exist if either of the following conditions is met: (i) in the case of a corporate entity, direct or indirect ownership of voting securities entitled to cast at least fifty percent (50%) of the votes in the election of directors or (ii) in the case of a non-corporate entity, direct or indirect ownership of at least fifty percent (50%) of the equity interests with the power to direct the management and policies of such entity. For the purposes of this Agreement, Company’s Affiliates shall not include [***], its affiliated funds and their respective portfolio companies.

 

2


1.4    “Antibody” means any antibody or antigen binding fragment thereof (including any bispecific or multispecific antibody, single chain antibody or domain antibody) and/or similar antigen binding protein, whether polyclonal, monoclonal, human, humanized, chimeric, murine, synthetic or from any other source.

1.5    “Approval” means, with respect to any Licensed Product in any regulatory jurisdiction, approval from the applicable Regulatory Authority sufficient for the manufacture, distribution, use, marketing, and sale of the Licensed Product in such jurisdiction in accordance with applicable Laws; provided, however that for purposes of the U.S., Approval means NDA Approval, for purposes of the EU, Approval means MAA Approval and for purposes of Japan, Approval means PMDA Approval.

1.6    “BMS Know-How” means Know-How that, as of the Effective Date, is Controlled by BMS or any of its Affiliates [***].

1.7    “BMS Patent Rights” means (a) the patents and patent applications listed in Appendix 1 or any Joint Patent Rights, (b) all divisionals, continuations, continuations-in-part thereof (excluding claims in continuations-in-part that necessarily rely on new matter invented by BMS after the Effective Date unless constituting any Joint Patent Right) or any other patent application claiming priority directly or indirectly to (i) any of the patents or patent applications in subsection (a), or (ii) any patent or patent application from which the patents or patent applications in (a) claim direct or indirect priority, (c) all patents issuing on any of the foregoing in (a) and (b), (d) all foreign counterparts of any of the foregoing in (a) through (c), including any patent applications filed under the Patent Cooperation Treaty (“PCT Applications”), and (e) all registrations, reissues, re-examinations, supplemental protection certificates, or extensions of any of the foregoing in (a) through (d). [***]

1.8    “BMS Platform Patent Rights” means (a) any claims in any patents or patent applications existing as of the Effective Date that are Controlled by BMS or any of its Affiliates and claim (1) the composition of matter or use of the [***] of the Licensed Compounds specifically, or (2) the composition of matter of any intermediate or starting material, or any process, reasonably necessary in or reasonably useful for the manufacture of any Licensed Compound as manufactured by or on behalf of BMS or any of its Affiliates as of the Effective Date, (b) all divisionals, continuations, continuations-in-part thereof (excluding claims in continuations-in-part that necessarily rely on new matter invented by BMS after the Effective Date) or any other patent application claiming priority directly or indirectly to (i) any of the patents or patent applications in subsection (a), or (ii) any patent or patent application from which the patents or patent applications in (a) claim direct or indirect priority, (c) all patents issuing on any of the foregoing in (a) and (b), (d) all foreign counterparts of any of the foregoing in (a) through(c), including any PCT Applications, and (e) all registrations, reissues, re-examinations, supplemental protection certificates, or extensions of any of the foregoing in (a) through (d). [***] For the sake of clarity, any Patent Right included in the definition of BMS Patent Rights is excluded from the definition of BMS Platform Patent Rights.

 

3


1.9    “Business Combination Transaction” means, with respect to a Party, the acquisition by such Party or any of its Affiliates, or merger or consolidation of such Party with, or the acquisition of a Party by, a Third Party or any business unit of a Third Party.

1.10    “Business Day” or “business day” means a day other than Saturday, Sunday or any day on which commercial banks located in New York, New York are authorized or obligated by Law to close.

1.11    “Calendar Quarter” means the respective periods of three consecutive calendar months ending on March 31, June 30, September 30 and December 31.

1.12    “Calendar Year” means each one-year period commencing on January 1 and ending on December 31.

1.13    “Change of Control” means with respect to any Party:

(a)    the acquisition, directly or indirectly, by any individual, entity or group (within the meaning of Section 13(d)(3) or 14(d)(2) of the Securities Exchange Act of 1934, as amended) (a “Specified Person” of beneficial ownership (within the meaning of Rule 13d-3 promulgated under the Securities Exchange Act of 1934, as amended) of fifty percent (50%) or more of either (i) the then Outstanding Common Stock of such Party or (ii) the combined voting power of the then Outstanding Voting Securities of such Party; provided, that for the purposes of this paragraph (a), the following acquisition of securities of such Party shall not constitute a Change of Control of such Party: (A) any acquisition by any employee benefit plan (or related trust) sponsored or maintained by such Party or any corporation controlled (as defined in the definition of “Affiliate”) by such Party or (B) any acquisition by any corporation or other entity (including such Party) pursuant to a transaction which complies with clauses (i) and (ii) of paragraph (b) of this definition;

(b)    the consummation by a Party of any Business Combination Transaction, unless immediately following such Business Combination Transaction, (i) the individuals and entities who were the beneficial owners, respectively, of the Outstanding Common Stock and Outstanding Voting Securities of such Party immediately prior to such Business Combination Transaction beneficially own, directly or indirectly, more than fifty percent (50%) of, respectively, the Outstanding Common Stock and the combined voting power of the Outstanding Voting Securities, as the case may be, of such Party or any other corporation or other entity resulting from such Business Combination Transaction (including such Party or a corporation or other entity which as a result of such transaction owns all the then-outstanding securities of such Party or all or substantially all of such Party’s assets either directly or through one or more subsidiaries) in substantially the same proportions as their ownership, immediately prior to such Business Combination Transaction, of the Outstanding Common Stock and Outstanding Voting Securities of such Party, as the case may be, and (ii) more than fifty percent (50%) of the members of the board of directors (or comparable governing body) of the corporation or other entity resulting from such Business Combination Transaction were members of the Incumbent Board at the time of the execution of the initial agreement, or of the action of the board of directors of such Party, providing for such Business Combination Transaction;

 

4


(c)    a Party or any of its Affiliates sells or transfers to any Specified Person(s) (other than (i) Affiliates of such Party, and (ii) the other Party or its Affiliates), in one or more related transactions, properties or assets representing all or substantially all of such Party’s business to which this Agreement relates at the time of such sale or transfer; or

(d)    the individuals who, as of the Effective Date, constitute the board of directors of such Party (the “Incumbent Board”) ceasing for any reason to constitute fifty percent (50%) or more of the board of directors of such Party; provided, that any individual becoming a director subsequent to the Effective Date whose election, or nomination for election by such Party’s stockholders, was approved by a vote of at least a majority of the directors then comprising the Incumbent Board shall be considered as though such individual were a member of the Incumbent Board, but excluding, for this purpose, any such individual whose initial assumption of office occurs as a result of an actual or threatened election contest with respect to the election or removal of directors or other actual or threatened solicitation of proxies or consents by or on behalf of a Specified Person other than the board of directors of such Party.

1.14    “Clinical Trial” means any human clinical study of a pharmaceutical product.

1.15    “Combination Product” means a Licensed Product that includes at least one additional active ingredient other than the Licensed Compound. Drug delivery vehicles, adjuvants, and excipients shall not be deemed to be “active ingredients”, except in the case where such delivery vehicle, adjuvant, or excipient is recognized by the FDA as an active ingredient in accordance with 21 CFR 210.3(b)(7).

1.16    “Commercialization” or “Commercialize” means activities directed to commercially manufacturing, obtaining pricing and reimbursement approvals and regulatory activities pertaining to same, marketing, promoting, distributing, importing, exporting or selling a Licensed Product.

1.17    “Commercially Reasonable Efforts” means, with respect to the efforts to be expended by a Party or its Affiliate with respect to any objective, activity or decision to be undertaken under this Agreement, those efforts that a similarly situated company within the biopharmaceutical industry ([***]) would reasonably use to accomplish such objective, activity or decision, [***].

1.18    “Competitive Compound” means any Antibody that is not a Licensed Compound and that acts through, and is designed to [***] as a primary mechanism of action.

1.19    “Confidential Information” means all trade secrets, processes, formulae, data, Know-How, improvements, inventions, chemical or biological materials, techniques, marketing plans, strategies, customer lists, or other information (including all information and materials of a Party’s customers and any other Third Party and their consultants) that has been disclosed by a Party to the other Party, regardless of whether any of the foregoing are marked “confidential” or “proprietary” or communicated to the other by the disclosing Party in oral, written, graphic, or electronic form. “Confidential Information” of BMS shall include the BMS Know-How.

 

5


1.20    “Controlled” or “Controls”, when used in reference to intellectual property, shall mean the legal authority or right of a Party (or any of its Affiliates) to grant a license or sublicense of intellectual property rights to the other Party or any Third Party, or to otherwise disclose proprietary or trade secret information to such other Party or to any Third Party, without breaching the terms of any agreement with any Third Party.

1.21    “Development” means non-clinical and clinical drug research and development activities , including for the development and submission of information to a Regulatory Authority, including chemistry, toxicology, pharmacology and other discovery and pre-clinical efforts, test method development and stability testing, process development, formulation development, research and development manufacturing, delivery system development, quality assurance and quality control development, clinical studies (including pre- and post-Approval studies but specifically excluding regulatory activities directed to obtaining pricing and reimbursement approvals), statistical analysis, and post-marketing commitments/requirements. When used as a verb, “Develop” means to engage in Development.

1.22    “Development Plan” means, with respect to a Licensed Product, a plan prepared by Company for the [***] setting forth a summary of the key Development activities to be conducted for such Licensed Product in all Major Market Countries, including the indications expected to be targeted, a good faith estimate of reasonable timelines for completing key Development activities and filing of key regulatory submissions (including estimated timelines for commencement of each stage of clinical Development), and including, where known, the primary endpoints and any comparator or any agents used in combination with a Licensed Compound or Licensed Product for any such studies and any go-no-go decision criteria for any such studies. The initial Development Plan as of the Effective Date is attached hereto as Appendix 2. All Development Plans will be Confidential Information of the Company. A copy of the study protocol for a given study will be provided to BMS if available and if requested by BMS.

1.23    “Distributor” means, with respect to a country, any Third Party that is used by pharmaceutical manufacturers generally in such country on a non-exclusive basis, and without any intellectual property right or license grant from the pharmaceutical manufacturers, to distribute, offer for sale and sell (but not to market or promote except to the extent reasonably necessary to so distribute) finished, packaged pharmaceutical products to pharmacies, managed care organizations, governmental agencies (e.g., federal, state and local), and other group purchasing organizations (e.g., pharmaceutical benefits managers) and the like in such country. For clarity, a Distributor of a Licensed Product in a country shall not include any person or entity that has been granted a right, whether by license or otherwise and whether express or implied (including by subcontract or agency), by a Party or its Affiliates to research, Develop or manufacture any such Licensed Product or that otherwise assumes any regulatory or other responsibilities with respect to obtaining or maintaining regulatory approvals for such Licensed Product in such country.

1.24    “Dollar” or “$” means the lawful currency of the United States.

1.25    “EMA” means the European Medicines Agency, or any successor agency thereto.

1.26    “EU” means the European Union, as its membership may be altered from time to time, and any successor thereto.

 

6


1.27    “FDA” means the U.S. Food and Drug Administration, or any successor agency thereto.

1.28    “Field” means all fields, including the prevention, treatment, diagnosis, detection, monitoring or pre-disposition treatment or control of any disease, disorder or condition in humans or animals.

1.29    “First Commercial Sale” means, with respect to any Licensed Product in a country in the Territory, the first sale for use or consumption by the general public of such Licensed Product in such country after Approval of such Licensed Product has been granted, or such marketing and sale is otherwise permitted, by the Regulatory Authority of such country.

1.30    “GAAP” means U.S. generally accepted accounting principles, consistently applied.

1.31    “Governmental Authority” means any multi-national, national, federal, state, local, municipal, provincial, county, or other political subdivision, agency or other body, domestic or foreign or other government authority of any nature (including any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, court, tribunal or other entity).

1.32    “Incoterms” means the year 2010 edition of the official International Chamber of Commerce’s rules for the interpretation of trade terms or any successor set of rules, guidelines or terms developed thereunder.

1.33    “IND” means an Investigational New Drug Application, as defined in the Act, filed with the FDA or its foreign counterparts, including as applicable clinical trial applications (CTAs), clinical trial exemptions (CTXs), and investigational medicinal product dossiers.

1.34    “Initiation” means, when used with respect to a Clinical Trial, the dosing of the first patient with the first dose in such Clinical Trial.

1.35    “Know-How” means tangible and intangible information, techniques, technology, practices, inventions (whether patentable or not), methods, knowledge, know-how, trade secrets, data and results (including all biological, chemical, pharmacological, toxicological, clinical, analytical and quality control data and methods (including any applicable reference standards), manufacturing assay and related data, data and results relating to drug substance, drug product, starting materials, cell culture media, and radiolabeled compounds, know-how and trade secrets).

1.36    “Knowledge” means, with respect to a Party or its Affiliates, the actual knowledge of [***] based on such individuals’ good faith understanding of the facts and information in their possession or control without any duty to conduct any additional investigations with respect to such facts and information.

1.37    “Laws” means all applicable laws, statutes, rules, regulations and other pronouncements having the effect of law of any Governmental Authority that may be in effect from time to time, including for clarity any applicable rules, regulations and other requirements of any Regulatory Authority that may be in effect from time to time.

 

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1.38    “Licensed Compound” means the [***] and all modifications, derivatives, fragments or variants thereof. A description of [***] is set forth in Appendix 3.

1.39    “Licensed Product” means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms. For clarity, “other active ingredients” does not include any other active ingredients or molecules that are proprietary to, or controlled by, BMS and its Affiliates.

1.40    “MAA” means a marketing authorization application filed for Approval in [***], of the applicable Licensed Product.

1.41    “MAA Approval” means Approval by [***] of a MAA (including an Abbreviated Application) filed with [***] for the applicable Licensed Product under the centralized European procedure. If the centralized [***] filing procedure is not used, MAA Approval shall be achieved upon the first Approval for the applicable Licensed Product in [***]; provided, that MAA Approval shall in any event be deemed achieved upon First Commercial Sale in any country in the [***].

1.42    “Major Market Countries” means the following countries: [***]. “Major Market Country” means any one of these countries.

1.43    “NDA” means a new drug application filed with the FDA required for marketing approval for the applicable Licensed Product in the U.S., or, if the Licensed Compound is a biologic, a biologics license application (BLA) filed with the FDA required for marketing approval for the applicable Licensed Product in the U.S.

1.44    “NDA Approval” means the final approval of an NDA (including an Abbreviated Application) for a given indication by the FDA for the applicable Licensed Product in the U.S.; provided, that, for milestone payment purposes, NDA Approval shall in any event be deemed achieved upon First Commercial Sale in the U.S. for such indication.

1.45    “Net Sales” means, with respect to any Licensed Product, the amount billed in arm’s-length transactions by a Party, an Affiliate of such Party, or any permitted Sublicensee (or such Sublicensee’s Affiliates) (all of the foregoing persons and entities, for purposes of this definition and Sections 8.4, 8.6, and 8.7, shall be considered a “Related Party”) for sales of such Licensed Product to a Third Party, less the sum of the following (to the extent not reimbursed by any Third Party):

[***]

No deduction shall be made for any item of cost incurred by any Related Party in Developing or Commercializing Licensed Products except as permitted pursuant to clauses [***] of the foregoing sentence; provided that, Licensed Products sold or transferred to Third Parties in connection with clinical and non-clinical research and trials, Licensed Product samples, compassionate sales or use, or an indigent program or for similar bona fide business purposes in accordance with applicable local laws and regulations in which a Related Party agrees to forego a normal profit margin for good faith business purposes shall give rise to Net Sales only to the extent that any Related Party invoices or receives amounts therefor exceeding the cost of goods.

 

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Such amounts shall be determined consistent with a Related Party’s customary practices and in accordance with GAAP.

It is understood that any accruals for individual items reflected in Net Sales are periodically (at least quarterly) trued up and adjusted by each Related Party consistent with its customary practices and in accordance with GAAP.

Sale or transfer of Licensed Products between any of the Related Parties shall not result in any Net Sales, with Net Sales to be based only on any subsequent sales or dispositions to a non-Related Party (including any Distributor). To the extent that any Related Party receives consideration other than or in addition to cash upon the sale or disposition of a Licensed Product to a non-Related Party, Net Sales shall be calculated based on the average price charged for such Licensed Product, as applicable, during the preceding royalty period, or in the absence of such sales, based on the fair market value of the Licensed Products, as determined by the Parties in good faith. For clarity, (i) Net Sales shall not include amounts or other consideration received by a Related Party from a non-Related Party in consideration of the grant of a (sub)license or copromotion or distribution right to such non-Related Party, provided that such consideration is not in lieu of all or a portion of the transfer price of the Licensed Product, (ii) sales to a Third Party Distributor, wholesaler, group purchasing organization, pharmacy benefit manager, or retail chain customer shall be considered sales to a non-Related Party and not to a Sublicensee, (iii) Net Sales by a Related Party to a non-Related Party consignee are not recognized as Net Sales by such Related Party until the non-Related Party consignee sells the Licensed Product and (iv) if a Related Party receives in-kind consideration for the sale of the Licensed Product, then Net Sales shall be calculated as the fair market value of the Licensed Product, as determined by the Parties in good faith.

In the case of any Combination Product sold in the Territory, Net Sales for such Combination Product shall be calculated by [***].

Should Company, its Affiliates or Sublicensees enter into a Third Party agreement for the purchase of a Licensed Product that provides discounts or rebates on such Licensed Product that are conditioned on pricing terms or conditions for purchase of another product or products owned or Controlled by Company, its Affiliates or Sublicensees, as the case may be, then the discount or rebate on such Licensed Product under such agreement shall be determined, for purposes of determining Net Sales under this Agreement for a given accounting period, based on the based on the lowest discount or rebate provided to any other product sold under such agreement.

1.46    “Outstanding Common Stock” means, with respect to a Person at any time, the then outstanding common stock of such Person.

1.47    “Outstanding Voting Securities” means, with respect to a Person at any time, the then outstanding voting securities of such Person entitled to vote generally in the election of directors of such Person.

1.48    “Patent Rights” means (a) patents and patent applications, (b) all divisionals, continuations, continuations-in-part thereof or any other patent application claiming priority directly or indirectly to (i) any of the patents or patent applications in subsection (a), or (ii) any

 

9


patent or patent application from which the patents or patent applications in (a) claim direct or indirect priority, (c) all patents issuing on any of the foregoing in (a)-(b), (d) all foreign counterparts of any of the foregoing in (a)-(c), including PCT Applications, and (e) all registrations, reissues, re-examinations, supplemental protection certificates, or extensions of any of the foregoing in (a)-(d).

1.49    “Person” means any individual, firm, corporation, partnership, limited liability company, trust, business trust, joint venture, governmental authority, association or other entity.

1.50    “Phase 1 Trial” means a Clinical Trial of a Licensed Product on a sufficient number of subjects that is designed to provide a preliminary determination of safety, pharmacokinetics, and pharmacodynamic parameters in healthy individuals or patients.

1.51    “Phase 2 Trial” means a Clinical Trial of a Licensed Product, including a separate Clinical Trial or the second part of a fused “Phase 1/2” Clinical Trial, on a sufficient number of subjects that is designed to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population.

1.52    “Phase 3 Trial” means a Clinical Trial of a Licensed Product, including a separate Clinical Trial or the second part of a fused “Phase 2/3” Clinical Trial, on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such pharmaceutical product in the dosage range and dose duration to be prescribed, which trial is intended to support Approval of a Licensed Product.

1.53    “PMDA” means the Japanese Pharmaceutical and Medical Device Agency or its successor, or Ministry of Health, Labour and Welfare.

1.54    “PMDA Approval” means Approval by the PMDA of an MAA (including an Abbreviated Application) filed with the PMDA for the applicable Licensed Product in Japan.

1.55    “Regulatory Authority” means any Governmental Authority, including the FDA, PMDA or EMA, that has responsibility in countries in the Territory over the Development and/or Commercialization of the Licensed Compounds and/or Licensed Products.

1.56    “Regulatory/Marketing Exclusivity” means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, any additional market protection, other than Patent Right protection, granted by a Regulatory Authority for such Licensed Product in such country or other jurisdiction which (a) confers an exclusive Commercialization period during which Company or its Affiliates or Sublicensees can exclusively market and sell such Licensed Product in such country or other jurisdiction through such regulatory exclusivity right, including rights conferred in the United States under the Biologics Price Competition and Innovation Act (BPCIA) (including pediatric exclusivity) and the Hatch Waxman Act or the FDA Modernization Act of 1997 (including pediatric exclusivity), orphan drug exclusivity, or rights similar thereto outside the United States, or (b) limits or prohibits a Person from relying on pivotal safety or efficacy data generated by or on behalf of a Party or the Parties with respect to such Licensed Product in an Abbreviated Application for Approval.

 

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1.57    “Sublicense Revenues” means all consideration paid or otherwise given by a Third Party Sublicensee to Company or any of its Affiliates with respect to the grant of a Sublicense, including any upfront payment, milestone payments, and collaboration fees, and premium on equity investments in Company (with the premium to be reasonably allocated to the value of the Licensed Compounds and Licensed Products as compared to any other compounds and products, if any, controlled by Company or any of its Affiliates), but excluding, for clarity, any amounts received by Company or any of its Affiliates: (a) as bona fide fair market value, reimbursement for research, development and/or commercialization activities performed plus a reasonable overhead, or paid for, by Company or any of its Affiliates after the grant of the Sublicense and only to the extent that they are documented and are reasonably detailed in a written report to BMS, (b) for reimbursement of Company’s (or its Affiliate’s) fully-burdened cost to manufacture and supply Licensed Compounds or Licensed Products plus a reasonable overhead, (c) in the form of bona fide loans made by the Sublicensee to Company or its Affiliates not forgiven by the Sublicensee to Company or its Affiliates, (d) payment or reimbursement of reasonable patent expenses actually incurred or paid by Company or its Affiliates and not otherwise reimbursed, (e) payments to Company or its Affiliates for purchase of equity in Company or its Affiliate at the fair market value for such equity and (f) any royalties, profit-sharing or other recurring payments based on Net Sales or other sales of Licensed Products for which a royalty is payable under this Agreement. For clarity, in the event that a Sublicense by Company includes both a grant of rights under any of the BMS Patent Right, BMS Platform Patent Rights or the BMS Know-How on the one hand, and any grant of rights to or sale of other patent rights or know-how controlled by Company (the “Other Sublicensed IP”), the Parties shall negotiate in good faith a reasonable adjustment to the applicable Sublicense Revenue (shared with BMS) that takes into account the relative value of the Other Sublicensed IP, provided that if they cannot agree on such adjustment, then the Parties will select an independent appraiser to determine such adjustment.

1.58    “Sublicense” means a grant of rights by Company to a Sublicensee under any of the rights licensed to Company by BMS under Section 2.1 with respect to the Development, manufacture, or Commercialization of any Licensed Product or Licensed Compound, and includes any reverse co-promotion agreements. For clarity, a Distributor is not considered a Sublicensee.

1.59    “Sublicense Agreement” means a written, definitive agreement for a Sublicense.

1.60    “Sublicensee” means any Third Party or Affiliate of the Company to whom rights are granted under any of the rights licensed to Company by BMS under Section 2.1 with respect to any Licensed Product or Licensed Compound, including through any license, sublicense, co-development, co-discovery, co-promotion, distribution, joint venture, Development and Commercialization collaboration or similar transaction between Company (or an Affiliate of Company) and a Third Party, that constitutes a Sublicense.

1.61    “Target” means interleukin-7 receptor (IL-7R).

1.62    “Territory” means worldwide.

1.63    “Third Party” means any Person other than Company, BMS, and their respective Affiliates.

 

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1.64    “United States” or “U.S.” means the United States of America including Puerto Rico and any U.S. territories and possessions.

1.65    “Valid Claim” means a claim of (i) an issued and unexpired patent or a supplementary protection certificate, which claim has not been held invalid or unenforceable by a court or other government agency of competent jurisdiction from which no appeal can be or has been taken and has not been held or admitted to be invalid or unenforceable through re-examination or disclaimer, opposition procedure, nullity suit or otherwise, or (ii) a pending patent application that has not been finally abandoned, finally rejected or expired; provided, however, that if a claim of a pending patent application shall not have issued within [***] (or in [***] or [***], [***]) after the earliest filing date from which such claim takes priority, such claim shall not constitute a Valid Claim for the purposes of this Agreement unless and until a patent issues with such claim.

Additional Definitions. In addition to those terms defined above, definitions for each of the following terms are found in the body of this Agreement as indicated below:

 

Defined Term

 

Section

Additional Third Party Licenses   8.4.4
Agreement   Preamble
BMS   Preamble
BMS Reversion Products   13.4.1
CHO Cell Line License   9.2.2
Company   Preamble
Company Improvements Patent Rights   2.4
Effective Date   Preamble
Force Majeure   15.3
Incumbent Board   1.13(d)
Indemnification Claim   12.3
Indemnitee   12.3
Indemnitor   12.3
Indication   8.2.1(iv)
Inventory Disposal Period   13.4.6
Investors’ Rights Agreement   8.1.2
Joint Invention   10.1
Joint IP   10.1
Joint Patent Rights   10.1
Know-How Transfer Period   3.1
Losses and Claims   12.1
Party or Parties   Preamble
PCT Application   1.7
Related Party   1.45
ROFN   5.7.1
Royalty Term   8.4.2
Series A Purchase Agreement   8.1.2
[***]   9.2.2

 

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Specified Person   1.13
Surviving Sublicensee   2.2.1(g)
TA Period   3.2
Title 11   13.9
Transferred Materials   4.1
Triggering Event   5.6.2
Voting Agreement   8.1.2

ARTICLE 2

LICENSE GRANT

2.1    BMS Patent Rights, BMS Platform Patent Rights and BMS Know-How.

2.1.1    Subject to all the terms and conditions set forth in this Agreement, BMS hereby grants to Company a non-transferable (except in accordance with Section 15.4), exclusive license, with the right to grant Sublicenses through multiple tiers in accordance with Section 2.2, under the BMS Patent Rights and BMS Know-How solely to the extent necessary to research, discover, Develop, Commercialize, make, have made, use, sell, offer to sell, export and import Licensed Compounds and/or Licensed Products in the Field in the Territory.

2.1.2    Subject to all the terms and conditions set forth in this Agreement, BMS hereby grants to Company a non-transferable (except in accordance with Section 15.4), non-exclusive license, with the right to grant Sublicenses through multiple tiers in accordance with Section 2.2, under the BMS Platform Patent Rights solely to the extent necessary to research, discover, Develop, Commercialize, make, have made, use, sell, offer to sell, export and import Licensed Compounds and/or Licensed Products in the Field in the Territory.

2.1.3    For clarification, nothing in this Section 2.1 or this Agreement shall be interpreted as a grant of rights to make, have made, sell, use, co-formulate or use in combination a Licensed Compound with any molecule (i) that is not a Licensed Compound and is proprietary to BMS or any of its Affiliates or would require a license from BMS with respect to the composition, method of use or manufacture of such other molecule, or (ii) that is or could be subject to a governmental grant providing marketing exclusivity with respect to such compound or such product (such as data exclusivity under the FDA’s Orange Book or under national implementations of Article 10.1 of Directive 2001/EC/83), including but not limited to, in each case (i) and (ii), any such compound or such product that is being developed or sold (as of the Effective Date or in the future) by BMS or its Affiliates or by contractors or collaborators with or on behalf of BMS or its Affiliates.

2.2    Sublicenses. Company shall have the right to grant Sublicenses through multiple tiers with respect to the rights licensed to Company under Section 2.1: (x) to an Affiliate without the prior written consent of BMS and (y) to a Third Party subject to BMS’ prior written consent (not to be unreasonably withheld, delayed or conditioned), provided that, in each case (x) and (y), such Sublicenses are granted solely in accordance with this Section 2.2:

 

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2.2.1    Company shall have the right to enter into a Sublicense Agreement with a Third Party, provided that:

(a)    such Sublicense Agreement shall refer to this Agreement and shall be subordinate to and consistent with the terms and conditions of this Agreement, and, shall not limit Company’s ability to fully perform all of its obligations under this Agreement or BMS’ rights under this Agreement;

(b)    in such Sublicense Agreement, the Sublicensee shall agree in writing to be bound to Company by terms and conditions that allow Company to fully perform the corresponding terms and conditions of this Agreement;

(c)    promptly after the execution of such Sublicense Agreement, Company shall provide a copy of such Sublicense Agreement to BMS subject to reasonable redactions to the extent not necessary to confirm Company compliance with this Agreement;

(d)    Company shall remain primarily responsible for all payments due and the making of reports under this Agreement by its Sublicensees and for compliance by its Sublicensees with all applicable terms of this Agreement (including, without limitation, its payment obligations under Sections 11.1 and Articles 8 and 10 hereof), and shall use Commercially Reasonable Efforts to monitor such Sublicensees’ compliance with the terms of such Sublicense. Company shall remain jointly and severally liable with each of its Sublicensees (whether or not such Sublicensee is an Affiliate of Company) for any failure by such Sublicensee to comply with the terms and conditions of this Agreement;

(e)    the Sublicensee shall assume and agree in writing to be bound by and comply with the terms and conditions of this Agreement in the same manner as Company, including, without limiting the generality of the foregoing, any such Sublicensee shall agree in writing (i) to maintain insurance coverage at no less than the levels set forth in Section 12.4, (ii) to keep books and records substantially in accordance with Section 8.7, including permitting audit and inspection rights in accordance with Sections 8.7.3 and 8.7.4, (iii) the right of termination provided in Section 13.2.4, and (iv) to grant to BMS rights consistent with Section 2.4;

(f)    such Sublicensee shall not have the right to grant further Sublicenses with respect to the Development or Commercialization of Licensed Products, except in accordance with and subject to all of the terms and conditions of this Section 2.2 and all of the other terms and conditions of this Agreement;

(g)    any Sublicense rights granted by Company in a Sublicense Agreement (to the extent such Sublicense rights are granted to Company in this Agreement) shall terminate effective upon the termination under Article 13 of the license from BMS to Company with respect to such sublicensed rights, provided that such Sublicense rights shall not terminate if, as of the effective date of such termination under Article 13, the

 

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Sublicensee is not in material breach of its obligations to Company under its Sublicense Agreement, the Sublicensee was previously granted an exclusive Sublicense to Develop and Commercialize the Licensed Products or Licensed Compounds, and within [***] of such termination the Sublicensee agrees in writing to be bound directly to BMS under a license agreement substantially similar to this Agreement with respect to the rights Sublicensed hereunder, substituting such Sublicensee (a “Surviving Sublicensee”) for Company, and provided further that (A) such license agreement shall not prejudice any remedy either Party may have against the other in connection with such termination of this Agreement (in whole or in part); (B) the scope of the rights granted to the Surviving Sublicensee under such license agreement (with respect to licensed activities, Licensed Products and territory) shall be less than or equal to the scope of the rights that had been sublicensed by Company to the Surviving Sublicensee pursuant to the Sublicense Agreement; (C) Company shall no longer be obligated under this Agreement to pay amounts set forth in this Agreement, to the extent such amounts are payable based on the activities of such Surviving Sublicensee, its Affiliates and its sublicensees from and after the effective date of such termination; (D) such license agreement shall obligate the Surviving Sublicensee to pay directly to BMS amounts corresponding to those set forth in Article 8 which are payable based on the activities of such Surviving Sublicensee, its Affiliates and its sublicensees from and after the effective date of such termination; (E) the Sublicensee cures any payment default of the Company to BMS as of the effective date of termination; and (F) such license agreement shall not modify the rights and obligations of the Parties following any termination of this Agreement in whole or in part; and

(h)    the provisions of this Section 2.2 shall also apply in the event of any subsequent amendment or modification of any such Sublicense Agreement.

2.2.2    For clarity, where provisions of this Agreement provide that Company shall be “solely” responsible or the like with respect to a matter (for example, Sections 5.4, 5.5, or 7.1), it is understood that such responsibilities may be carried out or borne on Company’s behalf by an Affiliate of Company or by a permitted Sublicensee or contractor of Company.

2.2.3    It shall be a material breach of this Agreement for Company to enter into any Sublicense hereunder not in compliance with this Section 2.2. Company or its Affiliates or Sublicensees may (i) engage a Third Party, including a contractor or contract research organization, to perform research or Development activities with respect to Licensed Compounds and/or Licensed Products on behalf of Company or its Affiliates or Sublicensees, (ii) engage a Third Party, including a contractor or contract manufacturing organization, to perform manufacturing activities with respect to Licensed Compounds and/or Licensed Products on behalf of Company or its Affiliates or Sublicensees, and (iii) engage a contract sales organization to perform promotional (but not sales) activities with respect to Licensed Compounds and/or Licensed Products on behalf of Company or its Affiliates or Sublicensees and such activities shall not be deemed a Sublicense if only the right to perform limited and specific research or Development activities hereunder or such manufacturing or promotional activities with respect to Licensed Compounds and/or Licensed Products on behalf of Company or its Affiliates or Sublicensees in furtherance of its obligations is granted under the BMS Patent Rights, BMS Platform Patent Rights or the

 

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BMS Know-How (or any other rights granted to Company under this Agreement); provided, that (a) none of the rights of BMS hereunder are diminished or otherwise adversely affected as a result of such engagement, (b) any such Third Party shall enter into an appropriate written agreement obligating such Third Party to be bound by obligations of confidentiality and restrictions on use of BMS’ Confidential Information that are no less restrictive than the obligations in this Agreement; and (c) Company shall at all times be responsible for the performance of such Third Party. Company or its Affiliates or Sublicensees (as applicable) shall use Commercially Reasonable Efforts to secure an agreement from such Third Party to assign or license (with the right to sublicense) to Company inventions to the extent relating to the Licensed Compounds and/or Licensed Products (and Patent Rights covering such inventions) made by such Third Party in performing such services for Company.

2.3    No Trademark License. No right or license, express or implied, is granted to Company to use any trademark, trade name, trade dress, domain name, logos, slogans, or service mark owned or Controlled by BMS or any of its Affiliates. Company, at its sole cost and expense, shall be responsible for the selection, registration and maintenance of all trademarks which it employs in connection with Licensed Products and its activities conducted pursuant to this Agreement, if any, and shall own and Control such trademarks.

2.4    License to BMS. Company hereby grants to BMS an irrevocable, perpetual, fully paid-up, royalty-free, sublicensable non-exclusive license under the Company Improvements Patent Rights. Such license shall survive the expiry or termination of this Agreement for any reason. “Company Improvements Patent Rights” means Patent Rights Controlled by Company claiming inventions by or on behalf of Company and its Affiliates and Sublicensees that are (a) improvements to the BMS Platform Patent Rights and (b) conceived or created by or on behalf of Company or its Affiliates or Sublicensees in furtherance of the Development or Commercialization of Licensed Compounds or Licensed Products pursuant to this Agreement. Company shall use Commercially Reasonable Efforts to secure an agreement from its Third Party contractors to assign or license (with the right to sublicense) to Company any improvements to any inventions claimed in the BMS Platform Patent Rights (and Patent Rights claiming such inventions) made by such Third Party in performing such services for Company in furtherance of the Development or Commercialization of Licensed Compounds or Licensed Products pursuant to this Agreement.

2.5    No Implied Licenses. No license or other right is or shall be created or granted hereunder by implication, estoppel or otherwise. All such licenses and rights are or shall be granted only as expressly provided in this Agreement.

2.6    Retained Rights. All rights not expressly granted by a Party hereunder are reserved by such Party and may be used by such Party for any purpose. Without limiting the foregoing, BMS retains all rights to use and for its Affiliates to use the Licensed Compounds, the BMS Know-How, the BMS Patent Rights and the BMS Platform Patent Rights for any internal preclinical research purposes in the Field, to research, develop and commercialize any molecules other than the Licensed Compounds and Licensed Product, and for the manufacture of any compound that is not a Licensed Compound. Nothing in this Agreement shall prevent BMS and its Affiliates from using for any purpose any BMS Know-How that is in the public domain as of the Effective Date (or enters the public domain thereafter) and is not covered by a Valid Claim of a BMS Patent Right licensed to Company hereunder.

 

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ARTICLE 3

TRANSFER OF KNOW-HOW, TECHNICAL ASSISTANCE

3.1    Documentation.

3.1.1    During the [***] period following the Effective Date (the “Know-How Transfer Period”) BMS shall provide Company with electronic (or tangible embodiments, if electronic is not available) of the Know-How listed on Appendix 5 (including upon request of Company within such [***] period, copies of originals of laboratory notebooks or pages thereof) and, where required by Company to fulfill its duties under applicable Law, copies of manufacturing run records required to be maintained by BMS under applicable Law; provided that, with respect to BMS Know-How contained in laboratory notebooks, BMS shall only be required to provide Company with copies of those laboratory notebook pages (electronic copies, if they exist) that can be readily located without unreasonable search and that contain BMS Know-How relating to Licensed Compounds. Such documentation is Confidential Information of BMS and shall not be used by Company for any purpose other than for the discovery, research, Development or Commercialization (including any import, manufacture, use, offer for sale, or sale) of Licensed Compounds and/or Licensed Products in accordance with this Agreement. Company shall assume full responsibility and liability to BMS for any unauthorized use or disclosure of such Confidential Information. BMS shall be responsible for the cost of providing one (1) set of copies (electronic, where they exist) only. BMS shall have no obligation to reformat or otherwise alter or modify any materials, or to create materials in electronic form, in order to provide them to Company. Any and all materials and other BMS Know-How delivered to Company pursuant to this Section 3.1 are and shall remain the sole property of BMS.

Without limiting the foregoing, if, within [***] after the Effective Date, Company reasonably determines that there is additional, specific BMS Know-How Controlled by BMS and its Affiliates that existed as of the Effective Date that is reasonably necessary for the continued Development or manufacture (but only those manufacturing and formulation processes, techniques and trade secrets used by BMS for making such Licensed Compounds as of the Effective Date) of any Licensed Compound or Licensed Product that has not been provided during the Know-How Transfer Period, then Company may request within such [***] period that BMS transfer to Company such additional BMS Know-How and BMS will endeavor to locate and provide same, provided that BMS shall not be required to conduct an unreasonable search for any such additional BMS Know-How.

3.1.2    Notwithstanding Section 3.1.1 or 3.2, nothing herein shall require BMS to transfer, disclose or provide to Company (i) any reagents, assays or other tangible biological or chemical materials that are not listed on Appendix 4, and (ii) any general information or know-how that should reasonably be known to a pharmaceutical company engaged in the research, development, manufacture or commercialization of Antibodies.

 

 

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3.2    Technical Assistance. During the [***] period following the Effective Date (the “TA Period”), BMS shall reasonably cooperate with Company to assist Company with understanding and using the BMS Know-How provided to Company under Section 3.1. Such cooperation shall include, without limitation, providing Company with reasonable access by teleconference or in-person at BMS’ facilities (subject to BMS’ customary rules and restrictions with respect to site visits by non-BMS personnel) to BMS personnel who are appropriately qualified and experienced for such purpose, directly involved in the research and Development of Licensed Compounds and Licensed Products. In no event shall BMS be obligated to provide Company with more than (x) [***] of technical assistance and consultation in connection with the BMS Know-How transferred under Section 3.1 to the extent the Know-How does not relate to manufacturing Know-How, and (y) [***] technical assistance and consultation in connection with the BMS Know-How transferred under Section 3.1 to the extent it relates to manufacturing Know-How; provided that upon Company’s request and at BMS’s sole discretion, BMS may provide additional technical assistance beyond the foregoing [***], at a mutually agreed commercially reasonable [***] rate, up to an additional [***]. Further: (i) such access shall be requested and coordinated through a single contact person to be designated by BMS, (ii) BMS makes no warranty, express or implied, that Company shall be able to successfully implement and use the BMS Know-How, and (iii) BMS shall not be in default hereunder for any inadvertent failure to disclose all pertinent information related to the BMS Know-How, provided that such information shall be supplied to Company promptly upon discovery of such failure to disclose or upon request of Company identifying with reasonable specificity the nature of the information to be disclosed. Company shall be responsible for ensuring that its personnel who receive such assistance are appropriately qualified and experienced for such purpose.

3.3    IND. As between the Parties, Company shall be solely responsible at its expense to prepare and file an IND for the Licensed Compound.

3.4    Media. Promptly following the Effective Date and during the term of this Agreement, BMS will authorize [***] (and during the term of this Agreement shall maintain such authorization) to manufacture for Company and its Affiliates and Sublicensees the cell culture media as used by BMS with respect to the Licensed Compounds as of the Effective Date. Company and its Affiliates and Sublicensees shall use such cell culture media solely for the Development and Commercialization of the Licensed Compounds and Licensed Products. Company shall not, and shall procure that its Affiliates, Sublicensees and Third Party contractors do not, reverse engineer or otherwise intentionally attempt to discern the structure, identity and/or components of such cell media. For clarity, such cell culture media is considered BMS Know-How, the use of which by Company and its Affiliates and Sublicensees is subject to the terms and conditions of this Agreement. Notwithstanding Section 3.1.1 or 3.2, BMS shall not be required to transfer, disclose or provide to Company any further BMS Know-How with respect to such cell media except as specifically set forth in this Section 3.4. Company shall at all times be responsible for compliance by its Affiliates, Sublicensees, and Third Parties with the terms of this Section 3.4.

 

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ARTICLE 4

TRANSFER OF MATERIALS

4.1    Materials. Within [***] after the Effective Date (except as otherwise set forth in Appendix 4), BMS shall deliver those licensed products and other materials identified in Appendix 4 ExWorks (as defined in INCOTERMS 2010) at the delivery location (at BMS sites located [***]) to a third party logistics provider, selected by Company and approved by BMS, such approval not to be unreasonable withheld, for each such material in the quantities set forth in Appendix 4 (any such materials that are actually transferred, the “Transferred Materials”). These Transferred Materials are provided free of charge to the Company. Title and risk of loss shall be transferred to and borne by Company upon the earlier to occur of (i) delivery of the Transferred Materials by BMS at such delivery locations [***] onto the carrier designated by Company or (ii) receipt by BMS of an agreement signed by Company and [***] to the effect that title and risk of loss of material located at [***] (see Appendix 4) has been accepted by Company and that the material will remain at the same location (or be transferred pursuant to an agreement between Company and [***]), and that Company shall be responsible for any direct or indirect taxes levied upon the transfer, including customs duties and import VAT if applicable. The Company will furnish to BMS an applicable, properly completed tax exempt certificate for each relevant jurisdiction for Transferred Materials provided for the benefit of research and development, in which case the expectation is that the Company will not be invoiced for sales and use taxes as such taxes are not applicable. Other than the Transferred Materials, BMS shall have no obligation to provide Company with any compounds or other materials, such as assays or biomaterials, under this Agreement. The Transferred Materials are provided “AS IS” and BMS makes no representations or warranties, express or implied, as to the Transferred Materials, including any warranty as to merchantability or fitness for a particular use or purpose. Any requalification required for Transferred Materials will be at Company’s expense and responsibility. Company agrees that: (a) Company shall be fully responsible for its and its Affiliates’, Sublicensees’ and contractors’ use, storage, handling and disposition of the Transferred Materials, (b) under no circumstances shall BMS be liable or responsible for Company’s or its Affiliates’, Sublicensees’ and contractors’ use, storage, handling or disposition of the Transferred Materials, and (c) Company assumes sole responsibility for any claims, liabilities, damages and losses that might arise as a result of Company’s and its Affiliates’, Sublicensees’ and contractors’ use, storage, handling or disposition of any Transferred Material. Company shall indemnify, defend and hold harmless BMS and its Affiliates, and their respective officers, directors, employees, agents, licensors, and their respective successors, heirs and assigns and representatives, from and against any and all damages, liabilities, losses, costs and expenses (including reasonable legal expenses, costs of litigation and reasonable attorney’s fees) arising in connection with any claims, suits, proceedings, whether for money damages or equitable relief, of any kind, arising out of or relating to Company’s, or any of its Affiliates’, Sublicensees’ or contractors’ use, storage, handling or disposition of any Transferred Material. Transferred Materials may only be provided by Company to Affiliates of Company, Sublicensees and contractors of Company.

 

 

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ARTICLE 5

DEVELOPMENT

5.1    Development. Company shall itself or through its Affiliates or Sublicensees use Commercially Reasonable Efforts to Develop one or more Licensed Products, including by (i) setting forth in the Development Plan a program of Development activities and reasonable estimated timelines therefor for each phase of pre-clinical and clinical Development for any such Licensed Compounds and Licensed Products, and (ii) assigning appropriately qualified and experienced personnel to perform and monitor the progress of, or overseeing Third Parties who perform, such Development activities on an on-going basis. The initial Development Plan as of the Effective Date is attached hereto as Appendix 2. During the term of this Agreement, Company shall (a) promptly provide BMS no later than [***] of each Calendar Year with a copy of the revised Development Plan for each Licensed Compound and Licensed Product for such Calendar Year and the next two Calendar Years and (b) promptly notify BMS as if, as a result of interactions with Regulatory Authorities in relation to the Licensed Product, Company reasonably determines that the estimated timelines for Development and Commercialization for Licensed Products set forth in the Development Plan are likely to be materially delayed, and shall promptly thereafter update the Development Plan to reflect such revised estimated timelines. Company shall promptly notify BMS of any material change in any study included in the Development Plan last provided to BMS of which it becomes aware and the reasons therefor.

5.2    Development Reports. Company shall provide BMS with written Development reports on or before [***] of each Calendar Year during the term of Development activities summarizing (but without disclosing specific data or results) such activities in sufficient detail to enable BMS to determine Company’s compliance with its diligence obligations in Section 5.1. Such reports shall include without limitation (a) the research and other Development activities accomplished by Company under the existing Development Plan through the end of the immediately preceding Calendar Year with respect to Licensed Compounds and Licensed Products, (b) updates on Company’s progress against the existing Development Plan, and (c) any revisions proposed to be made to any Development Plan for the then current Calendar Year; provided, however, that the first such report shall be due no later than [***]. If any such Development obligations have been sublicensed to a Sublicensee, Company shall require the Sublicensee to provide to BMS the same information as required of Company hereunder with respect to the progress of the development of Licensed Compounds and Licensed Products by such Sublicensee. If requested by BMS, Company (and, if applicable, Sublicensee) personnel who prepared the report will meet with BMS (which may be by teleconference) to discuss any reasonable questions or comments that BMS might have on the report and Company’s development activities.

5.3    Records. Company shall maintain complete and accurate records of all work conducted in furtherance of the research, Development and Commercialization of the Licensed Compounds and/or Licensed Products and all results, data and developments made in furtherance thereof to the extent required under applicable Laws. Such records shall properly reflect all work done and results achieved in sufficient detail and in good scientific manner to the extent required under applicable Laws.

 

 

20


5.4    Development Responsibilities and Costs. As between the Parties, Company shall have sole responsibility for, and shall bear the cost of conducting, research and Development with respect to the Licensed Compounds and/or Licensed Products. Company shall research and Develop the Licensed Compounds and/or Licensed Products in compliance with all applicable Laws, including all legal and regulatory requirements pertaining to the design and conduct of Clinical Trials.

5.5    Regulatory Responsibilities and Costs. As between the Parties, Company shall have sole responsibility for, and shall bear the cost of preparing, all regulatory filings and related submissions with respect to the Licensed Compounds and/or Licensed Products. Except as set forth in Article 13, as between the Parties, Company shall own all INDs, Approvals and submissions in connection therewith and all Approvals shall be obtained by and in the name of Company.

5.6    Competitive Compound.

5.6.1    

(a)    During the period that ends on the earlier of the date that (x) royalties are owed under this Agreement or (y) that is ten (10) years after the Effective Date, neither Company nor its Affiliates (or any Sublicensee of Company or any Affiliate of such Sublicensee) shall itself or through any Third Party, or in collaboration with any Third Party, engage, directly or indirectly in the clinical Development or Commercialization of a Competitive Compound.

(b)    During the period that ends on the [***] anniversary of the Effective Date, neither BMS or any of its Affiliates shall commence any internal discovery or development program with the intent of identifying or developing a Competitive Compound (but, for clarity, BMS may in-license or otherwise acquire a Competitive Compound).

(c)    During the period ending on the [***] anniversary of the Effective Date, neither BMS nor its Affiliates will out-license (or otherwise authorize any others to initiate or continue) the BMS Know-How for the purpose of clinically developing or commercializing a Competitive Compound.

5.6.2    Notwithstanding Section 5.6.1, if a Party or any of its Affiliates, either through its own development efforts or by acquisition, or obtains ownership of or a license to, or is acquired by or otherwise merges with an entity (or an Affiliate of such entity) that owns or has a license to, a Competitive Compound, in all such cases that would result in a violation of Section 5.6.1 (any such event, a “Triggering Event”), then such Party shall promptly notify the other Party in writing and elect (as applicable) one of the following actions within [***] after such Triggering Event:

(a)    (A) with respect to Company, terminate this Agreement pursuant to Section 13.3 with the resulting consequences, or (B) with respect to either Party, cease development or commercialization of, or divest itself of such Competitive Compound and notify the other Party in writing of such divestiture, which divestiture may occur by an outright sale to a Third Party of all of such Party’s and its Affiliate’s rights to such

 

 

21


Competitive Compound or by an outlicense arrangement under which such Party has no continuing active involvement in the development or commercialization of such Competitive Compound (for clarity, efforts in connection with (i) the receipt and audit of payments in respect of the Competitive Compound, (ii) the maintenance, defense and enforcement of any applicable licensed patents, and (iii) the receipt of information to ensure compliance with the applicable agreement (including efforts to enforce or terminate same, or seek damages, for breach) shall not constitute continuing active involvement) provided that such cessation or divestiture occurs within [***] after the applicable Triggering Event; provided, that such Party or its Affiliate shall (x) have an additional [***] to effect such divestiture in the event that such Party or its Affiliate can demonstrate it has used commercially reasonable efforts, but has been unable, to effect such divestiture during such [***] period; provided further that, (1) for purposes of this clause (B)(x) with respect to Company only, Company or its Affiliate shall be entitled to terminate this Agreement pursuant to Section 13.3 with the resulting consequences with the resulting consequences if Company or its Affiliate is unable to divest such Competitive Compound within the time period contemplated herein, and (y) have such additional time as may be necessary to cease any on-going clinical trials in a commercially reasonable manner in accordance with applicable Laws; or

(b)    with respect to Company, negotiate terms under which the Competitive Compound would be included as a Licensed Product within this Agreement. If the Parties can agree and execute a binding agreement, within [***] after notice from Company electing this option, on the terms (including compensation to BMS) for including the Competitive Compound as a Licensed Product or Licensed Compound within this Agreement and Company’s Commercially Reasonable Efforts obligations under Sections 5.1 and 6.1, then Company shall not be deemed in breach of Section 5.6.1; provided, that BMS shall not be under any obligation, express or implied to negotiate or enter into any such agreement. If the Parties are unable to reach written agreement during the applicable time period, then, this Agreement shall be deemed terminated pursuant to Section 13.3.2 hereof.

5.7    Right of First Negotiation.

5.7.1    If at any time prior to [***] for the first Licensed Compound or Licensed Product for which [***] is available in accordance with Section 5.7.2, Company determines that it wishes to Sublicense to a Third Party the right to commercialize any of the Licensed Compounds or the Licensed Products, Company will promptly notify BMS in writing of same and the territory as to which the sublicense will cover, and BMS will have the right to elect to exercise a right of first negotiation (“ROFN”) to regain the rights under the BMS Patent Rights, BMS Platform Patent Rights, and BMS Know-How as it relates to such Licensed Compounds or Licensed Products (either through a sublicense back to BMS or a buy-out of Company’s rights) for such territory, for a period of [***] thereafter. If the Parties, after using good faith efforts, are unable to execute a definitive agreement with respect to such transaction within such period, or BMS does not elect to exercise the ROFN, Company will have the right, subject to Section 5.7.2, to enter into discussions with and execute any sublicense or other transaction with respect to such Licensed Compounds or Licensed Products in such territory on financial terms in the

 

 

22


aggregate not better than those last offered to BMS by Company provided BMS exercised the ROFN (and further provided that Company may re-start this ROFN process at its election).

5.7.2    Upon delivery of the [***] for the first Licensed Compound or Licensed Product for which [***] is available, unless already sublicensed or otherwise transacted upon as provided pursuant to Section 5.7.1, Company will provide written notice thereof to BMS, including a summary of all data generated by Company as of such time, including any filings with FDA, with respect to such Licensed Compound or Licensed Product. Upon receipt of such notice, BMS will have the right to elect to exercise a ROFN to regain the rights under the BMS Patent Rights, BMS Platform Patent Rights, and BMS Know-How as it relates to such Licensed Compound or Licensed Product (either through a sublicense back to BMS or a buy-out of Company’s rights), for a period of [***] of the receipt of the notice. If the Parties, after using good faith efforts, are unable to execute a definitive agreement with respect to such transaction within such period, or BMS does not elect to exercise the ROFN, Company will have the right to enter into discussions with and execute any sublicense or other transaction with respect to such Licensed Compound or Licensed Product in the Territory on financial terms in the aggregate not better than those last offered to BMS by Company provided BMS exercised the ROFN (and further provided that Company may re-start this ROFN process at its election).

5.7.3    The rights granted to BMS under Sections 5.7.1 and 5.7.2 shall terminate in their entirety upon any Change of Control of Company, where the Third Party engaging with Company in such Change of Control transaction (or its Affiliate) has a market capitalization of [***] or more as of the last day of the Calendar Quarter ended prior to the consummation of such Change of Control and such Third Party (or its Affiliate or other entity resulting from such Change of Control transaction) intends to develop and commercialize after the consummation of the Change of Control transaction one or more Licensed Products on its own behalf.

5.7.4    For clarity, (a) nothing shall prevent Company or any of its Affiliates from negotiating or executing any confidentiality agreement or participating in general discussions with any existing or potential Sublicensees or collaborators (including existing or potential co-marketing and co-promotion contractors) or acquirers or merger candidates, and (b) Company shall have no obligation to provide BMS with (i) the identity of any Third Party or (ii) any terms of any transaction negotiated with a Third Party (except in connection with the performance of this Section 5.7).

ARTICLE 6

COMMERCIALIZATION

6.1    Company Obligations. Company shall use Commercially Reasonable Efforts to (i) obtain Approvals in each Major Market Country for [***], (ii) effect the First Commercial Sale of each Licensed Product for which such Approvals are obtained into each Major Market Country as soon as reasonably practicable after receipt of such Approvals and (iii) Commercialize each such Licensed Product in each such Major Market Country following such First Commercial Sale therein with the goal of maximizing the Net Sales of such Licensed Product in such Major Market Country.

 

 

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6.2    Continued Availability. Following the First Commercial Sale of a Licensed Product in a country in the Territory and until the expiration or termination of this Agreement, Company shall be responsible for manufacturing (or having manufactured) at its sole expense and using Commercially Reasonable Efforts to maintain supplies of such Licensed Product sufficient to satisfy Company’s expected Commercialization efforts in such country.

6.3    Reports. Following the First Commercial Sale of a Licensed Product in a country in the Territory, Company shall provide BMS with a written report within [***] of the filing of the Company Annual Report with the U.S. Securities and Exchange Commission (or if no such report is filed, then by [***] of a calendar year), summarizing [***]. If requested by BMS, Company personnel who prepared the report will meet with BMS, which may be by teleconference, to discuss and answer any questions or comments that BMS might have on the report and Company’s commercialization activities.

ARTICLE 7

MANUFACTURE AND SUPPLY

7.1    Manufacture and Supply. As between the Parties, Company shall be solely responsible at its expense for all of its requirements for making or having made all of its requirements of the Licensed Compounds and/or Licensed Products, except for Transferred Materials.

ARTICLE 8

FINANCIAL TERMS

In partial consideration of the rights granted by BMS to Company pursuant to this Agreement, Company shall make the payments provided for in this Article 8.

8.1    Initial Payment.

8.1.1    Within twenty (20) days after the Effective Date, Company shall pay to BMS a nonrefundable, noncreditable payment of Eight Million Dollars ($8,000,000) in cash by electronic funds transfer into an account designated in writing by BMS.

8.1.2    Within twenty (20) days after the Effective Date, Company shall issue to BMS Series A preferred stock of Company equal to [***] of Company’s capital stock on a fully-diluted basis at the time of issuance (as calculated based on Company’s capitalization table attached hereto as Appendix 6), and, notwithstanding anything in (a) the Amended and Restated Certificate of Incorporation of the Company as filed with the Secretary of State of Delaware on July 26, 2018, as amended (the “Series A Purchase Agreement”), (b) the Series A/A1 Preferred Stock Purchase Agreement, dated as of July 28, 2018, as amended, by and among the Company and the Purchasers party thereto, (c) the Investors’ Rights Agreement, dated as of July 26, 2018, as may be amended, by and

 

24


among the Company and the Investors party thereto (the “Investors’ Rights Agreement”), (d) the Voting Agreement, dated as of July 26, 2018, as may be amended, by and among the Company, the Investors and the Key Holders party thereto (the “Voting Agreement”), and (e) the Right of First Refusal and Co-Sale Agreement, dated as of July 26, 2018, as may be amended, by and among the Company, the Investors and the Key Holders party thereto, concurrent with any subsequent issuances of equity by Company, BMS shall be entitled to receive without any additional consideration that number of additional shares of Company preferred stock as is required for BMS to maintain its [***] equity ownership in Company (on a fully-diluted basis); provided that this anti-dilution right shall apply only until the date by which Company shall have raised [***] in proceeds from equity financings in the aggregate; provided further that with respect to equity financings prior to an initial public offering of the Company in excess of such [***], BMS shall have the right (but not the obligation) to participate, in its sole discretion, in any such financings on the same terms and conditions (including price) as the other investors in order to maintain its [***] ownership interest in Company (on a fully diluted basis), as set forth in that certain Investor Rights Agreement to which BMS will become a party. The shares of preferred stock issued by Company to BMS will have the same rights and privileges, and be subject to the same terms and conditions (e.g., voting rights, registration rights, rights of co-sale, etc.), as the preferred stock issued in connection with Company’s Series A financing, achieved by BMS executing a joinder to the applicable agreements substantially in the form attached hereto as Appendix 7.

8.2    Milestone Payments.

8.2.1    Development Milestones. Company shall pay to BMS the following milestone payments set forth in the table below within [***] after the first achievement of the specified milestone event by Company, its Affiliates, and Sublicensees for the first Licensed Product to achieve such milestone event. Company shall provide written notice to BMS within [***] after the first achievement of the specified milestone event by Company, Affiliates, and Sublicensees. Each milestone payment shall not be refundable or returnable in any event, nor shall it be creditable against royalties or other payments:

 

Milestone Event

   1st Indication   2nd Indication   3rd Indication

[***]

   [***]   [***]   [***]

[***]

   [***]   [***]   [***]

[***]

   [***]   [***]   [***]

[***]

   [***]   [***]   [***]

[***]

   [***]   [***]   [***]
  

 

 

 

 

 

Total

   [***]   [***]   [***]
  

 

 

 

 

 

For purposes of this Section 8.2.1:

(i)    The set of milestone payments in the table above shall be payable by Company to BMS upon the first achievement of each such milestone event for the first such Licensed Compound to achieve the milestone event.

 

 

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(ii)    For each such Licensed Compound as subsequently achieves the same milestone event as the first Licensed Compound has achieved, the milestone payment shall be (1) [***] of the payments set forth in the above table and (2) subject to the credit as set forth in clause (iii) below.

(iii)    If Development is discontinued for a Licensed Compound or Licensed Product before the Approval is obtained in [***] for that Licensed Compound or Licensed Product, the milestone payments achieved for the next most advanced subsequent Licensed Compound or Licensed Product in Development, will be waived for any previously paid milestone payments for that discontinued Licensed Compound or Licensed Product.

(iv)    For purposes of this Section, (i) “Indication” shall mean any separately defined, well-categorized class of human disease, syndrome or medical condition for which a separate marketing authorization application is required to be filed with a Regulatory Authority, (ii) new forms, presentations, dosages or formulations Developed for a given Licensed Compound shall not be deemed to create a new Licensed Compound for milestones purposes and shall be considered the same Licensed Compound, (iii) approval for the treatment and prevention of the same disease, syndrome or medical condition are the same Indication, except where the applicable patient population is materially expanded by virtue of such approval, in which case the approval for such treatment or prevention will be deemed to be a new Indication, and (iv) the approved use in a different line of treatment or a different temporal position for the same disease, syndrome or medical condition (e.g., first line vs. second line therapy for the same disease) are the same Indication.

(v)    Skipped Milestones. If a milestone payment becomes due with respect to a Licensed Product for an Indication before an earlier listed milestone payment became due for such Indication for any reason, then the earlier listed milestones for such Indication shall be payable upon achievement of the later listed milestone. For example, if the payment for [***] milestone event becomes due prior to the payment for [***] milestone event, then upon achievement of [***], both the [***] milestone payment [***] milestone event and the [***] milestone payment for the [***] milestone event would be payable.

8.2.2    Sales-Based Milestones. Each of the following milestone payments shall be paid by Company to BMS within [***] after the first achievement by Company, its Affiliates, and/or Sublicensees of the corresponding total Net Sales amount in a Calendar Year for Licensed Products set forth in the table below:

 

Calendar Year Worldwide Net Sales

   Milestone
Payment

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]
  

 

Total

   $215 million
  

 

 

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For clarity, the Net Sales of all Licensed Products shall be aggregated to determine the total Net Sales amount in a Calendar Year. Each milestone payment shall be paid only once. Each milestone payment shall not be refundable or returnable in any event, nor shall it be creditable against royalties or other payments.

8.3    Change of Control of Company and Sublicense Revenue Sharing.

8.3.1    Change of Control of Company.

(a)    If Company undergoes a Change of Control before initiating a [***] of a Licensed Product, each of the milestone payments payable to BMS pursuant to Section 8.2.1 and Section 8.2.2 shall be multiplied by a factor dependent upon the development stage of the Licensed Product at the time of such Change of Control of Company, as follows:

 

Development Stage as of the Date of Change of Control

   Milestone Multiple

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

(b)    If Company undergoes a Change of Control before initiating [***] of a Licensed Product, the royalty rate payable to BMS pursuant to Section 8.4 shall be increased at each tier by an amount dependent upon the stage of the Licensed Product at the time of such Change of Control of Company, as follows, with a maximum royalty rate of ten percent (10%):

 

Development Stage as of the Date of Acquisition

   Increase in Royalty

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

8.3.2    Sublicense Revenue Sharing. In addition to the milestones and royalty payments set forth in Sections 8.2 and 8.4, Company shall pay to BMS the following percentage of all Sublicense Revenues Company receives in connection with the grant of any Sublicense of the BMS Patent Rights, the BMS Platform Patent Rights, the Licensed Compounds and/or Licensed Products, depending on the stage of Development of the most advanced Licensed Compound or Licensed Product that is subject to the applicable Sublicense as of the effective date of such Sublicense:

 

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Development Stage as of the Date of Sublicense

   % of Sublicense Revenue
Payable to BMS

[***]

   60%

[***]

   [***]

[***]

   [***]

[***]

   [***]

For clarity (i) the percent stated above shall apply to any particular Sublicense Revenue that is received by Company from a Sublicensee but is not included in the Agreement (e.g., the upfront payment from the Sublicensee or a milestone payment for a milestone event not included in the Agreement), and (ii) if Company pays a milestone payment under Section 8.2 for achieving a milestone event for which Company receives Sublicense Revenue from a Sublicensee for achieving the same milestone, then the amount of Company’s payment to BMS under Section 8.2 shall be deducted from such Sublicensee’s payment for purposes of this Section 8.3.2 and shall not be subject to the percentage share.

8.4    Royalty Payments.

8.4.1    Subject to the terms of this Agreement Company shall pay to BMS tiered royalties based on the total annual worldwide Net Sales in the Territory of each Licensed Product (including all indications and formulations for such Licensed Product) during the applicable Royalty Term for such Licensed Product. The royalty payable with respect to each particular Licensed Product shall be calculated by multiplying the applicable royalty rate below by the portion of total annual worldwide Net Sales in the applicable tier in a Calendar Year of the applicable Licensed Product by Company, its Affiliates, and Sublicensees in the Territory, as follows.

 

Portion of total annual worldwide Net Sales in a
Calendar Year for such Licensed Product that
falls within the following tiers:

   Royalty Rate
[***]    [***]
[***]    [***]
[***]    [***]
[***]    10%

[***]

8.4.2    Royalty Term. In consideration of the licenses granted hereunder with respect to the BMS Patent Rights, the BMS Platform Patent Rights and the BMS Know-How, royalties shall be payable on a Licensed Product-by-Licensed Product and country-by-country basis on Net Sales of Licensed Products from the First Commercial Sale of a particular Licensed Product in a country during the period between the first commercial sale of such Licensed Product in such country until the later of (i) twelve (12) years from the First Commercial Sale in such country, or (ii) the expiration of the last to expire BMS Patent Right or BMS Platform Patent Right (with respect to a BMS Platform Patent Right, solely to the extent claiming the composition of matter or use of [***] of the Licensed Compounds specifically), (including any extension therefor under applicable

 

28


laws, such as patent term extensions, pediatric exclusivity or supplemental protection or their equivalent in any country) with a claim covering the applicable Licensed Compound or Licensed Product, their respective use, importation or manufacture with respect to such country, or (iii) the expiration of any Regulatory/Marketing Exclusivity for such Licensed Product in such country (the “Royalty Term”). The above royalty rates will be reduced during the Royalty Term for a given country where no BMS Patent Right or BMS Platform Patent Right (with respect to a BMS Platform Patent Right, solely to the extent claiming the composition of matter or use of [***] of the Licensed Compounds specifically) claims the Licensed Compound or Licensed Product, their respective use, importation or manufacture in that country. The royalty rate for such country in that event will be [***] of the weighted average royalty rate for all other countries in which the manufacture, use, sale or importation of the Licensed Compound or Licensed Product would otherwise infringe a BMS Patent Right but for the license rights granted hereunder; provided however that the royalty rate paid on Net Sales of a Licensed Product that is subject to clause (iii) shall be at the same rate as the normal (unadjusted) royalty rate described in the table above.

8.4.3    Royalty Conditions. The royalties under Section 8.4.1 shall be subject to the following conditions:

(a)    only one royalty shall be due with respect to the same unit of Licensed Product;

(b)    no royalties shall be due upon the sale or other transfer among any Related Party, but in such cases the royalty shall be due and calculated upon the Related Party’s Net Sales of Licensed Product to the first non-Related Party; and

(c)    no royalties shall accrue on the disposition of Licensed Product in reasonable quantities by any Related Party as part of an expanded access program or as bona fide samples or as donations to non-profit institutions or government agencies for non-commercial purposes or for the performance of clinical trials, provided, in each case, that such Related Party does not receive any payment for such Licensed Product exceeding the cost of goods.

8.4.4    Royalty Reduction. In the event Company determines that it will be necessary or useful to obtain additional licenses to patent rights of third parties (“Additional Third Party Licenses”) that cover the applicable Licensed Compound in such Licensed Product as a composition of matter or method of use in order to research, develop, manufacture and/or commercialize the Licensed Compounds or the Licensed Products, Company will be solely responsible for negotiating and obtaining any such Additional Third Party Licenses but will not be obligated to do so. Up to [***] of any royalties (but not upfront payments or milestones) paid under any such Additional Third Party Licenses will be credited towards the royalty payment above but not to more than [***] of the royalty amounts otherwise due and payable to BMS in relation to the Licensed Compound or Licensed Product for which the Additional Third Party Licenses were obtained by Company. For clarity, this credit will not apply with respect to third party patent rights covering the formulation or method of manufacture of a Licensed Compound or Licensed Product or the other active ingredient of a Combination Product. Notwithstanding the

 

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foregoing, if the royalty rates have been reduced in a given country due to a BMS Patent Right no longer covering the Licensed Product, then no additional offset for Additional Third Party License payments will be allowed for such country. Notwithstanding the royalty reductions based on lack of a BMS Patent Right covering a Licensed Product, and/or third party license payments, under no circumstances will the royalty payments due to BMS for any Licensed Product in any given period be less than [***] of the rate/payment otherwise applicable. For clarity, Company may not carry over and apply any such royalty reductions, which are incurred or accrued in a Calendar Quarter and are not deducted in such Calendar Quarter, to any subsequent Calendar Quarter(s).

8.4.5    Forecast. The Company shall provide on or before [***] of each Calendar Year a non-binding good faith forecast of (a) development milestones for the entire current and next Calendar Year and (b) sales and royalties for the entire current and next Calendar Year for such Licensed Product (starting with the Calendar Year during which the First Commercial Sale of a Licensed Product is expected).

8.4.6    Effect of Patent Challenge. In the event Company (or any of its Affiliates or Sublicensees) challenges or knowingly assists (other than in response to a subpoena or court order), including without limitation by providing information, documents, advice, and/or funding, a challenge to the validity, scope, patentability or enforceability of any of the BMS Patent Rights or BMS Platform Patent Rights, and such challenge is unsuccessful either because (i) Company (or any of its Affiliates or Sublicensees) files a suit or initiates another legal proceeding to challenging the validity or enforceability of any such BMS Patent Right or BMS Platform Patent Right and then withdraws or terminates the suit or proceeding, (ii) any challenged claim that would be infringed but for the license has been upheld, even in amended form, as determined by a court of competent jurisdiction or other legal tribunal, or (iii) Company (or any of its Affiliates or Sublicensees), in connection with such challenge, fails to produce reasonably credible evidence demonstrating the invalidity or unenforceability of all applicable patent claims in the BMS Patent Rights or BMS Platform Patent Rights in such country; then the royalty rates set forth in Section 8.4.1 above shall be increased by [***] of the percentages set forth above (e.g., [***] is increased to [***]), retroactively effective to the date that such suit or other legal proceeding was filed or otherwise formally initiated; provided that no such increase shall take effect if the foregoing prohibited activity was conducted by a Sublicensee and the Company terminates the applicable Sublicense Agreement in accordance with Section 13.2.4(b) or otherwise.

8.5    Manner of Payment. All payments to be made by Company under this Agreement shall be made in U.S. Dollars by wire transfer of immediately available funds to such bank account as shall be designated by BMS. Late payments shall bear interest at the rate provided in Section 8.10.

8.6    Sales Reports and Royalty Payments. After the First Commercial Sale of a Licensed Product and during the term of this Agreement, Company shall furnish to BMS a written report, within [***] after the end of each Calendar Quarter (or portion thereof, if this Agreement terminates during a Calendar Quarter), showing the amount of royalty due for such Calendar Quarter (or portion thereof). Royalty payments for each Calendar Quarter shall be due at the same

 

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time as such written report for the Calendar Quarter. With each quarterly payment, Company shall deliver to BMS a full and accurate accounting to include at least the following information:

8.6.1    the total gross sales for each Licensed Product (by country) by Company and its applicable Related Parties, if any, and the calculation of Net Sales from such gross sales;

8.6.2    the total Net Sales for each Licensed Product (by country) by Company and its applicable Related Parties, if any, and the calculation of Net Sales from such gross sales;

8.6.3    the calculation of royalties payable in Dollars which shall have accrued hereunder in respect of such Net Sales;

8.6.4    the deductions by category of permitted deductions set forth in the Net Sales definition, solely to the extent that any such deductions are not consistent with GAAP as applied by the party recording any such Net Sales;

8.6.5    withholding taxes, if any, required by applicable Law to be deducted in respect of such royalties; and

8.6.6    the exchange rates used in determining the amount of Dollars payable hereunder.

If no royalty or payment is due for any royalty period hereunder, Company shall so report.

8.7    Sales Record Audit.

8.7.1    Company shall keep, and shall cause each of its applicable Related Parties, if any, to keep, complete, true and accurate books of accounts and records in accordance with GAAP, including gross sales in accordance with GAAP and any deductions thereto in accordance with this Agreement’s Net Sales definition in connection with the calculation of Net Sales, sufficient to determine and establish the amounts payable incurred under this Agreement, and compliance with the other terms and conditions of this Agreement.

8.7.2    Such books of accounting of Company and its Affiliates shall be kept at their principal place of business and, with all necessary supporting data and records, shall during all reasonable times for the [***] next following the end of the Calendar Year to which each shall pertain, be open for inspection not more than once per Calendar Year at reasonable times by an independent certified public accountant selected by BMS and as to which Company has no reasonable objection, at BMS’ expense, for the purpose of verifying royalty statements and payments for compliance with this Agreement for any period within the preceding [***].

8.7.3    Company shall include in its Sublicense Agreements with any Sublicensees, a right for Company to have such an accountant inspect, not more than once

 

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during any Calendar Year, the books of accounting and such supporting data and records of such Sublicensees for the purpose of verifying royalty statements and payments for compliance with this Agreement for any period within the preceding [***].

8.7.4    Results of any inspection under Section 8.7.2 or 8.7.3 shall be made available to both Company and BMS. The independent, certified public accountant shall disclose to BMS only the amounts that the independent auditor believes to be due and payable hereunder to BMS, details concerning any discrepancy from the amount paid (including the reasons therefor) and the amount due, and shall disclose no other information revealed in such audit.

8.7.5    Such accountant must have agreed in writing to maintain all information learned in confidence, except as necessary to disclose to BMS such compliance or noncompliance by Company, and any applicable Related Parties (who must agree in the Sublicense Agreement that such audit report may be disclosed to BMS). The results of each inspection, if any, shall be binding on both Parties. BMS shall pay for such inspections, except that in the event there is any upward adjustment in aggregate royalties payable for any Calendar Year shown by such inspection of more than [***] of the amount paid, Company shall pay for such inspection. Any underpayments shall be paid by Company within [***] after notification of the results of such inspection. Any overpayments shall be fully creditable against amounts payable in subsequent payment periods.

8.8    Currency Exchange. The Company’s then current standard exchange rate methodology will be employed for the translation of foreign currency sales into Dollars, provided such methodology is used by the Company in the translation of its foreign currency operating results, is consistent with GAAP, and is audited by the Company’s independent certified public accountants in connection with the audit of the consolidated financial statements of Company, and is used for the Company’s external reporting of foreign currency operating results.

8.9    Taxes.

8.9.1    Each Party will pay any and all taxes levied on account of all payments it receives under this agreement.

8.9.2    If laws or regulations require that taxes be withheld with respect to any royalty payments by Company to BMS under this Agreement, Company will: (a) deduct those taxes from the remittable payment, (b) pay the taxes to the proper taxing authority, and (c) send evidence of the obligation together with proof of tax payment to BMS on a reasonable and timely basis following that tax payment. Each Party agrees to cooperate with the other Party in claiming refunds or exemptions from such deductions or withholdings under any relevant agreement or treaty which is in effect. The Parties shall discuss applicable mechanisms for minimizing such taxes to the extent possible in compliance with applicable Laws. BMS will pay any and all taxes levied on account of all payments it receives under this Agreement; provided, that notwithstanding the foregoing, in the event that payments are made by Company other than from the mainland U.S. (e.g., as a result of an assignment under Section 15.4.2), then Company shall, in addition to complying with the foregoing, pay an amount to BMS such that when any taxes that are

 

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required to be withheld have been deducted, BMS receives that amount it would have received had the payment been made from the mainland U.S.

8.9.3    The Parties shall cooperate in accordance with applicable Laws to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) in connection with this Agreement.

8.10    Interest Due. Without limiting any other rights or remedies available to BMS, Company shall pay BMS interest on any payments that are not paid on or before the date such payments are due under this Agreement at a rate of [***] above the prime rate (as published by the Wall Street Journal on the first day of the Calendar Quarter in which such payments are overdue) per month or the maximum applicable legal rate, if less, calculated on the total number of days payment is delinquent.

ARTICLE 9

REPRESENTATIONS AND WARRANTIES; DISCLAIMER;

LIMITATION OF LIABILITY

9.1    Mutual Representations and Warranties. Each Party represents and warrants to the other Party that, as of the Effective Date: (i) it is duly organized, validly existing and in good standing under the Laws of the jurisdiction of its incorporation and has all requisite corporate power and authority to enter into this Agreement and to perform its obligations under this Agreement, (ii) execution of this Agreement and the performance by such Party of its obligations hereunder have been duly authorized, (iii) this Agreement has been duly executed and delivered on behalf of such Party, and is legally binding and enforceable on each Party in accordance with its terms, (iv) the performance of this Agreement by it does not create a breach or default under any other agreement to which it is a Party, (v) the execution, delivery and performance of this Agreement by such Party does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any Law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party, (vi) no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any Laws currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements, and (vii) neither such Party, nor any of its employees, officers, subcontractors, or consultants who have rendered services relating to the Licensed Compounds: (a) has ever been debarred or is subject to debarment or convicted of a crime for which an entity or person could be debarred by the FDA under 21 U.S.C. Section 335a or (b) has ever been under indictment for a crime for which a person or entity could be so debarred.

9.2    Representations, Warranties, and Covenants of BMS.

9.2.1    BMS represents and warrants to Company that, as of the Effective Date: (a) there is no pending litigation, or litigation that has been threatened in writing, which alleges, or any written communication alleging, that BMS’ activities with respect to

 

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the research, Development or manufacture of the Licensed Compounds prior to the Effective Date have infringed or misappropriated, or would infringe or misappropriate, any of the Patent Rights or other intellectual property rights of any Third Party, (b) no Third Party has challenged in writing the ownership, scope, duration, validity, enforceability, priority or right to use any BMS Patent Rights or BMS Platform Patent Rights (including, by way of example, through the institution of or written threat of institution of interference, inter partes review, reexamination, protest, opposition, nullity or similar invalidity proceeding before the United States Patent and Trademark Office or any foreign patent authority or court), (c) all fees required to be paid by BMS in any jurisdiction in order to maintain the Patent Rights licensed to Company hereunder have, to BMS’ Knowledge, been timely paid as of the Effective Date and, to BMS’ Knowledge, the claims included in any issued patents included in such Patent Rights are in full force and effect as of the Effective Date, (d) BMS has not previously assigned, transferred, conveyed, or granted any license or other rights to its right, title and interest in the BMS Patent Rights, BMS Platform Patent Rights or the BMS Know-How, in any way that would conflict with or materially limit the scope of any of the rights or licenses granted to Company hereunder, (e) BMS’ right, title and interest to all the BMS Patent Rights and BMS Platform Patent Rights are free of any lien or security interest, (f) except as set forth in Appendix 1 and the BMS Platform Patent Rights, BMS and its Affiliates do not own or Control any other Patent Rights that are necessary or, to BMS’s reasonable belief as of the Effective Date, reasonably useful (in each case without taking into account the safe harbor under 35 USC § 271(e)(1) or any foreign equivalents) to carry out the Development of Licensed Compounds and/or Licensed Products as contemplated by the Development Plan attached as Appendix 2 hereto or Commercialization thereof, (g) subject to Section 3.1.2, to BMS’ Knowledge, the documents, data and information that are included in the BMS Know-How transferred to Company pursuant to Section 3.1 constitute all of the Know-How owned or Controlled by BMS that is reasonably necessary or useful for the Development or manufacture of the Licensed Compounds in accordance with the terms of this Agreement; and (h)the BMS Patent Rights constitute all Patent Rights Controlled by BMS or any of its Affiliates that claim as a composition of matter any Licensed Compound (other than (1) the composition of matter or use of [***] of the Licensed Compounds specifically, or (2) the composition of matter of any intermediate or starting material, or any process, reasonably necessary in or reasonably useful for the manufacture of any Licensed Compound as manufactured by or on behalf of BMS or any of its Affiliates as of the Effective Date).

9.2.2    BMS and [***]. BMS shall use Commercially Reasonable Efforts to obtain consent from [***] to (a) transfer to Company the [***] expressing the Licensed Compound to Company and (b) sublicense to Company BMS’s right to use the [***] expressing the Licensed Compound. For clarity, Commercially Reasonable Efforts shall not require BMS to pay any consideration for such consent. Upon receipt of such consent, and satisfaction of any conditions of such consent, the [***] expressing the Licensed Compound shall be considered Transferred Materials to be transferred to Company pursuant to Appendix 4 and such right to use the [***] expressing the Licensed Compound shall be deemed a BMS Platform Patent Right for purposes of this Agreement.

 

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9.2.3    As of the Effective Date, BMS is not internally developing, and has no active discovery program with respect to, any molecules that are designed to [***] the Target as a primary mechanism of action.

9.3    Representations, Warranties and Covenants of Company. Company represents, warrants and covenants that (a) it shall not engage in any activities that use the BMS Patent Rights, BMS Platform Patent Rights and/or BMS Know-How in a manner that is outside the scope of the license rights granted to it hereunder, (b) all of its activities related to its use of the BMS Patent Rights, BMS Platform Patent Rights, and BMS Know-How, and the research, Development and Commercialization of the Licensed Compounds and/or Licensed Products, or Licensed Products, pursuant to this Agreement shall comply with all applicable Law, (c) prior to issuance of Series A Preferred Stock to BMS in accordance with Section 8.1.2, the Company shall execute and deliver to BMS updated versions of the Investors’ Rights Agreement and Voting Agreement, each in the form attached hereto as Appendix 8, and in connection with the issuance of the Series A Preferred Stock to BMS, counsel for the Company shall issue to BMS a legal opinion in substantially the form issued to purchasers party to the Series A Purchase Agreement, and (d) a true and complete copy of the capitalization table of the Company as of the Effective Date has been made available to BMS.

9.4    DISCLAIMER. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO ANY LICENSED COMPOUNDS, LICENSED PRODUCTS, TRANSFERRED MATERIALS, THE BMS PATENT RIGHTS, BMS PLATFORM PATENT RIGHTS OR BMS KNOW-HOW OR ANY RIGHT OR LICENSE GRANTED BY BMS HEREUNDER, AND NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY BY BMS THAT ANY PATENT OR OTHER PROPRIETARY RIGHTS INCLUDED IN THE BMS PATENT RIGHTS OR BMS PLATFORM PATENT RIGHTS ARE VALID OR ENFORCEABLE OR THAT USE OF THE BMS PATENT RIGHTS, BMS PLATFORM PATENT RIGHTS, BMS KNOW-HOW AND TRANSFERRED MATERIALS CONTEMPLATED HEREUNDER DOES NOT INFRINGE ANY PATENT RIGHTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY.

9.5    Limitation of Liability. NOTWITHSTANDING ANYTHING IN THIS AGREEMENT OR OTHERWISE, NEITHER PARTY SHALL BE LIABLE TO THE OTHER WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT, WHETHER UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY, FOR ANY INCIDENTAL, INDIRECT, SPECIAL, EXEMPLARY, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES (INCLUDING, WITHOUT LIMITATION, LOST PROFITS, LOSS OF USE, DAMAGE TO GOODWILL, OR LOSS OF BUSINESS); PROVIDED, HOWEVER, THAT THE FOREGOING SHALL NOT APPLY TO ANY BREACH BY A PARTY OF ARTICLE 11 HEREOF, TO A BREACH BY EITHER PARTY OF SECTION 5.6, THE WILLFUL BREACH, WILLFUL MISCONDUCT, OR GROSS NEGLIGENCE BY A PARTY, OR FOR AMOUNTS SOUGHT BY THIRD PARTIES IN CLAIMS THAT ARE SUBJECT TO THE PARTIES’ RESPECTIVE INDEMNITY OBLIGATIONS UNDER ARTICLE 12. BMS SHALL NOT BE LIABLE FOR ANY DAMAGES

 

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OF ANY KIND (INCLUDING DIRECT DAMAGES) IN AN AMOUNT GREATER THAN THE AMOUNTS ACTUALLY PAID BY COMPANY TO BMS UNDER SECTIONS 8.1, 8.2 AND 8.4 OF THIS AGREEMENT; PROVIDED, HOWEVER, THAT THE FOREGOING SHALL NOT APPLY TO ANY BREACH BY BMS OF ARTICLE 11 HEREOF, TO A BREACH BY BMS OF SECTION 5.6, THE WILLFUL BREACH, WILLFUL MISCONDUCT, OR GROSS NEGLIGENCE BY BMS, OR FOR AMOUNTS SOUGHT BY THIRD PARTIES IN CLAIMS THAT ARE SUBJECT TO BMS’ INDEMNITY OBLIGATIONS UNDER ARTICLE 12. FOR THE AVOIDANCE OF DOUBT, THE FOREGOING LIMITATION SHALL NOT APPLY TO OR LIMIT ANY INFRINGEMENT CLAIM BROUGHT BY A PARTY UNDER THE PATENT LAWS OF ANY COUNTRY AND ANY DAMAGES IN THE NATURE OF LOST ROYALTIES TO BMS SHALL BE CONSIDERED DIRECT DAMAGES.

ARTICLE 10

PATENT MAINTENANCE; INFRINGEMENT; PATENT EXTENSIONS

10.1    Inventions. Inventorship of inventions conceived or reduced to practice in the course of research and other Development activities under this Agreement shall be determined by application of United States patent Laws pertaining to inventorship. If such inventions are jointly invented in the course of such Development activities by one or more employees or consultants or contractors of both Parties, such inventions shall be jointly owned (“Joint Invention”), and if one or more claims included in an issued patent or pending patent application which is filed in a patent office in the Territory claim such Joint Invention, such patent or patent application shall be jointly owned (“Joint Patent Rights”). In the event of Joint Patent Rights, the Parties shall agree on related issues, such as filing strategies, responsibilities, cost sharing and rights of use to such Joint Patent Rights. For clarity, nothing in this Agreement shall be interpreted as requiring either Party to file a patent application claiming a Joint Invention. If such an invention is solely invented by one or more employees or consultants or contractors of one Party, such invention shall be solely owned by such Party, and any issued patent or pending patent application only claiming such solely owned invention shall also be solely owned by such Party. This Agreement shall be understood to be a joint research agreement in accordance with 35 U.S.C. § 102(c), as amended, to develop the Licensed Compounds and/or Licensed Products. Each Party will have an undivided one half interest in and to the Joint Inventions and Joint Patent Rights (collectively, the “Joint IP”). Each Party will exercise its ownership rights in and to such Joint IP, including the right to license and sublicense or otherwise to exploit, transfer, or encumber its ownership interest, without an accounting or obligation to, or consent required from, the other Party, but subject to the licenses hereunder and the other terms and conditions of this Agreement. At the reasonable written request of a Party, the other Party will in writing grant such consents and confirm that no such accounting is required to effect the foregoing regarding Joint IP. Each Party shall enter into binding agreements obligating all employees and consultants performing activities under or contemplated by this Agreement, including activities related to the BMS Patent Rights, BMS Platform Patent Rights, Licensed Compounds or Licensed Products, to assign his/her interest in any invention conceived or reduced to practice in the course of such activities to the Party for which such employee or consultant is providing its services. With respect to contractors, Company shall use good faith and reasonable efforts to secure an agreement from such contractor to assign or license (with the right to sublicense) to Company inventions (and patent rights covering such inventions) made by such contractor in performing such services for Company.

 

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10.2    Filing, Prosecution and Maintenance of BMS Patent Rights. Company will have lead responsibility, using an outside patent counsel selected by Company (outside patent selection to be subject to BMS’ approval, such approval not to be unreasonably withheld, delayed or conditioned), for the preparation, prosecution (including any interferences, reissue proceedings and reexaminations) and maintenance of the BMS Patent Rights. Company shall be responsible for the costs incurred with respect to the preparation, filing, prosecution and maintenance of the BMS Patent Rights. Company will use diligent efforts no less than it uses for its own patents to prepare, file, prosecute and maintain all BMS Patent Rights, provided, however, that Company does not represent or warrant that any patent will issue or be granted based on BMS Patent Rights. Company shall provide BMS with semi-annual updates of the filing, prosecution and maintenance status for each of the BMS Patent Rights, and shall promptly provide BMS copies of any material official correspondence to or from patent offices. BMS shall have the right to comment on and to discuss such prosecution and maintenance activities with Company, and Company shall consider and incorporate such reasonable BMS comments. The Parties shall reasonably consult with and cooperate with respect to the preparation, filing, prosecution and maintenance of the BMS Patent Rights, including by providing assistance as described in Section 3.2; Company shall reimburse BMS for its reasonable expenses incurred in connection therewith. Company shall not take any action during preparation, filing, prosecution and maintenance of the BMS Patent Rights that would materially adversely affect them (including reduction in claims scope), without BMS’ prior express written consent (which consent not to be unreasonably withheld, delayed or conditioned, and shall be considered to be given if Company notifies BMS of proposed claim amendments or cancellations and BMS fails to object within [***] of such notification). Company may file a notice with governmental patent offices of the exclusive license to the BMS Patent Rights granted to Company hereunder. Post-grant patent office proceedings involving the BMS Patent Rights, including oppositions, cancellations, inter partes review, and the like, shall be conducted by Company at the expense of Company, and Company shall promptly notify BMS of the initiation of such proceeding (or vice versa), and Company shall give BMS the opportunity to participate, at the sole expense of BMS, and BMS shall also participate and appear as required by the applicable rules governing such proceedings. Any settlement or compromise of such post-grant proceeding shall be subject to the approval of BMS, which approval shall not be unreasonably withheld, delayed or conditioned.

10.3    Patent Abandonment.

10.3.1    The Parties will confer and must mutually agree before any of the BMS Patent Rights may be abandoned in any country; provided that BMS shall not unreasonably withhold, delay or condition its consent to a request by Company to abandon a BMS Patent Right if such abandonment will not adversely affect the amount or duration of any royalty payable to BMS hereunder. Company shall provide BMS with notice of (a) the allowance and expected issuance date of any patent within the BMS Patent Rights, and (b) any of the deadline for filing a new patent application (including continuations and divisionals), and BMS shall provide Company with prompt notice as to whether BMS desires Company to file such new patent application.

10.3.2    Subject to Section 10.3.1, in the event that Company decides either (a) not to continue the prosecution or maintenance of a patent application or patent within the BMS Patent Rights in any country, or (b) not to file any new patent application

 

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requested to be filed by BMS, Company shall provide BMS with express written notice of this decision at least [***] prior to any pending lapse, abandonment or deadline thereof, as the case may be, or if a decision not to continue prosecution or maintenance is responsive to an official communication from governmental agency that is received by Company less than [***] prior to a deadline for taking action in response thereto, then the deadline for giving such notice to BMS shall be [***] of the time remaining for response after such communication is received by Company. In such event, provided that the Parties have not expressly agreed to abandon a patent or not file a patent application under Section 10.3.1, then Company shall provide BMS with an opportunity to assume responsibility for all external costs reasonably associated with the maintenance of such patent, or filing, further prosecution and/or maintenance of such patent application and any patent issuing thereon (such filing to occur prior to the issuance of the patent to which the application claims priority or expiration of the applicable filing deadline, as set forth above). In the event that BMS assumes such responsibility for the costs of such filing, prosecution and maintenance, Company shall transfer the overall responsibility for such filing, prosecution and maintenance of such patent applications and patents to BMS and Company shall no longer have any right or license in and to such patents and patent applications and patents issuing therefrom under this Agreement. In such case, BMS shall have the right to transfer the responsibility for such filing, prosecution and maintenance of patent applications and patents to patent counsel (outside or internal) of its choice. In such case, Company shall provide BMS with an update of the filing, prosecution and maintenance status for each of such patent applications and patents, including copies of any material official correspondence to or from patent offices. Company shall reasonably consult with and cooperate with BMS with respect to the preparation, prosecution and maintenance of such patent applications and patents by BMS.

10.4    Enforcement of BMS Patent Rights against Infringers.

10.4.1    Enforcement by Company. In the event that BMS or Company becomes aware of a suspected infringement of any BMS Patent Right or BMS Platform Patent Right in the Field, including actual or alleged infringement under 35 USC §271(e)(2) that is or would be infringing activity involving the using, making, importing, offering for sale or selling of articles that the Party reasonably believes infringes any of the BMS Patent Rights or BMS Platform Patent Rights conferred under this Agreement, such Party shall notify the other Party promptly, including all information available to such Party with respect to such alleged infringement, and following such notification, the Parties shall confer. Company shall have the first right, but shall not be obligated, to bring an infringement action for suspected infringement of the BMS Patent Right or BMS Platform Patent Rights in the Field at its own expense, in its own name and entirely under its own direction and control, subject to the following: (a) with respect to any BMS Platform Patent Right, such right to bring an infringement action shall be subject to the prior written consent of BMS (which may be withheld in its sole discretion; provided that in such event, BMS will provide a good faith communication to Company of the rationale for such withholding and an opportunity for the Parties to discuss alternative strategies to address such infringement); (b) BMS shall reasonably assist Company (at Company’s expense) in any action or proceeding being prosecuted for suspected infringement in the Field if so requested, including by being named or joined as a plaintiff to such actions or proceedings

 

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if requested by Company or required by Law, (c) BMS shall have the right to participate and be represented in any such suit by its own counsel at its own expense, and (d) no settlement of any such action or proceeding which restricts the scope, or adversely affects the enforceability, of a BMS Patent Right or BMS Platform Patent Rights in the Field may be entered into by Company without the prior written consent of BMS, which consent shall not be unreasonably withheld, delayed or conditioned, and further, no settlement of any such action or proceeding which pertains to the infringement of the BMS Patent Rights or BMS Platform Patent Rights by virtue of the Development or Commercialization of a Licensed Compound in the Field by a Third Party that is not a Sublicensee may be entered into by Company without the prior written consent of BMS, which consent shall not be unreasonably withheld, delayed or conditioned.

10.4.2    Timing; Enforcement by BMS. Company will have a period of [***] after its receipt or delivery of notice and evidence pursuant to Section 10.4.1 or receipt of written notice from a Third Party that reasonably evidences such infringement of the BMS Patent Rights, to elect to so enforce such BMS Patent Rights in the applicable jurisdiction (or to settle or otherwise secure the abatement of such infringement in accordance with Section 10.4.1), provided however, that such period will be (i) more than [***] to the extent applicable Law prevents earlier enforcement of such BMS Patent Right, and provided further that if such period is extended because applicable Law prevents earlier enforcement, Company shall have until the date that is [***] following the date upon which applicable Law first permits such proceeding, and (ii) less than [***] to the extent that a delay in bringing such proceeding against such alleged Third Party infringer would limit or compromise the remedies (including monetary relief, and stay of regulatory approval) available against such alleged Third Party infringer. In the event Company does not so elect (or settle or otherwise secure the abatement of such infringement) before the first to occur of (A) the expiration of the applicable period of time set forth in the preceding subsections (i) and (ii), or (B) [***] before the expiration of any time period under applicable Law, that would, if a proceeding was not filed within such time period, limit or compromise the remedies available from such proceeding, it will so notify BMS in writing and in the case where BMS then desires to commence a suit or take action to enforce the applicable BMS Patent Right in the applicable jurisdiction, BMS will thereafter have the right to commence such a suit or take such action to enforce the applicable BMS Patent Right, as applicable, at BMS’ expense, provided that BMS shall first consult with Company concerning the reasons Company elected not to bring such action and shall consider those reasons in good faith in deciding whether to bring such action. Company shall reasonably assist BMS (at BMS’ expense) in any action or proceeding being prosecuted if so requested, including by being named or joined as a plaintiff to such actions or proceedings if requested by BMS or required by Law. Company shall have the right to participate and be represented in any such suit by its own counsel at its own expense. No settlement of any such action or proceeding which restricts the scope, or adversely affects the enforceability, of a BMS Patent Right may be entered into by BMS without the prior written consent of Company, which consent shall not be unreasonably withheld, delayed or conditioned.

10.4.3    Withdrawal. If either Party brings an action or proceeding under this Section 10.4 and subsequently ceases to pursue or withdraws from such action or proceeding, it shall promptly notify the other Party and the other Party may substitute itself for the withdrawing Party under the terms of this Section 10.4.

 

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10.4.4    Damages. In the event that either Party exercises the rights conferred in this Section 10.4 and recovers any damages or other sums in such action, suit or proceeding or in settlement thereof, such damages or other sums recovered shall first be applied [***]. If such recovery is insufficient to cover all such [***], it shall be shared [***]. If after such reimbursement any funds shall remain from such damages or other sums recovered, such funds shall be [***]; provided, however, that [***].

10.5    Infringement of Third Party Rights.

10.5.1    The Parties will promptly notify each other of any allegation that any activity under this Agreement infringes or may infringe the intellectual property rights of any Third Party.

10.5.2    In any legal allegation related to the infringement of a Third Party intellectual property right, Company will have the first right to control, at its expense, the defense of such allegation. BMS will have the right, at its own expense and with its own choice of counsel, to be represented in the defense of the allegation.

10.5.3    The Parties will reasonably cooperate with each other in all respects with all matters related to the defense of any legal allegation under this section.

10.6    Patent Extensions. BMS and Company shall each reasonably cooperate with one another and shall use Commercially Reasonable Efforts in obtaining patent term extension (including any pediatric exclusivity extensions as may be available) or supplemental protection certificates or their equivalents in any country with respect to any BMS Patent Rights covering the Licensed Products. If elections with respect to obtaining such patent term extensions are to be made, Company shall have the right, at its discretion, to make the election to seek patent term extension or supplemental protection with respect to the applicable BMS Patent Right(s) for which such extension or supplemental protection should be sought, provided that Company shall use Commercially Reasonable Efforts to make such election so as to maximize the period of marketing exclusivity for the Licensed Product. For such purpose, for all Approvals, Company shall provide BMS with written notice of any expected Approval at least [***] prior to the expected date of Approval, as well as notice within [***] following receipt of each Approval confirming the date of such Approval. Notification of the receipt of an Approval shall be in accordance with Section 15.2 except that the notification shall be sent to:

Bristol-Myers Squibb Company

P.O. Box 4000

Route 206 & Province Line Road

Princeton, New Jersey 08543-4000

Attention: Vice President and Chief Patent Counsel

Telephone: [***]

Facsimile: [***]

 

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10.7    Data Exclusivity and Orange Book Listings. With respect to data exclusivity periods (including any available pediatric extensions) or periods under national implementations of Article 10.1 of Directive 2001/EC/83 (and all international equivalents), Company shall use Commercially Reasonable Efforts consistent with its obligations under applicable Law to seek, maintain and enforce all such data exclusivity periods available for the Licensed Products. With respect to patent listing filings in any FDA Orange Book (and equivalents) for issued patents for a Licensed Product, Company shall, consistent with its obligations under applicable Law, list in a timely manner and maintain all applicable BMS Patent Rights. At least [***] prior to an anticipated deadline for the filing of patent listing information for BMS Patent Rights, Company shall consult with BMS regarding the content of such filing, and shall consider BMS’s comments in good faith, provided that Company shall have the final decision right with respect to such filing, including the Patent Rights to be listed in any FDA Orange Book or equivalent. BMS shall provide, consistent with its obligations under applicable Law, reasonable cooperation to Company in filing and maintaining such Orange Book (and foreign equivalent) listings.

10.8    Notification of Patent Certification. Company shall notify and provide BMS with copies of any allegations of alleged patent invalidity, unenforceability or non-infringement of a BMS Patent Right pursuant to (i) if the Licensed Compound is not a biologic, a Paragraph IV Patent Certification by a Third Party filing an Abbreviated New Drug Application, an application under §505(b)(2) or other similar patent certification by a Third Party, and any foreign equivalent thereof, and (ii) if the Licensed Compound is a biologic, a bioequivalent or biosimilar application other similar filing or patent certification by a Third Party, and any foreign equivalent thereof. Such notification and copies shall be provided to BMS within [***] after Company receives such certification, and shall be sent to the address set forth in Section 10.4. In addition, upon request by BMS, Company shall provide reasonable assistance and cooperation (including making available to BMS documents possessed by Company that are reasonably required by BMS and making available personnel for interviews and testimony), at BMS’ cost, in any actions reasonably undertaken by BMS to contest any such patent certification.

10.9    No Conflict Actions. BMS shall not be required to take any action pursuant to Sections 10.4, 10.7 or 10.8 that BMS reasonably determines in its sole judgment and discretion conflicts with or violates any court or government order or decree that BMS is then subject to or otherwise may create legal liability on the part of BMS.

10.10    Assignment of BMS Patent Rights and BMS Platform Patent Rights; BMS Platform Patent Rights. Notwithstanding any provision in this Agreement to the contrary, BMS shall have the right to transfer or assign ownership of any BMS Patent Rights and BMS Platform Patent Rights as long as any such transfer or assignment is made expressly subject to the rights and licenses granted to Company under this Agreement and the transferee or assignee of the transferred or assigned BMS Patent Rights agrees in writing to prosecute and maintain such BMS Patent Rights in accordance with the terms of this Article 10. For the sake of clarity, as between the Parties, BMS will have sole right and authority, but not the obligation, to prepare, prosecute, maintain and enforce all BMS Platform Patent Rights, subject to Section 10.4.

 

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ARTICLE 11

NONDISCLOSURE OF CONFIDENTIAL INFORMATION

11.1    Nondisclosure. Each Party agrees that, for so long as this Agreement is in effect and for a period of [***] thereafter, a Party receiving Confidential Information of the other Party (or that has received any such Confidential Information from the other Party prior to the Effective Date) shall (i) maintain in confidence such Confidential Information using not less than the efforts such Party uses to maintain in confidence its own proprietary industrial information of similar kind and value, (ii) not disclose such Confidential Information to any Third Party without the prior written consent of the other Party, except for disclosures expressly permitted below, and (iii) not use such Confidential Information for any purpose except those permitted by this Agreement (it being understood that this clause (iii) shall not create or imply any rights or licenses not expressly granted under Article 2 or elsewhere under this Agreement).

11.2    Exceptions. The obligations in Section 11.1 shall not apply with respect to any portion of the Confidential Information that the receiving Party can show by competent proof:

11.2.1    is publicly disclosed by the disclosing Party, either before or after it is disclosed to the receiving Party hereunder; or

11.2.2    was known to the receiving Party or any of its Affiliates, without any obligation to keep it confidential or any restriction on its use, prior to disclosure by the disclosing Party; or

11.2.3    is subsequently disclosed to the receiving Party or any of its Affiliates by a Third Party lawfully in possession thereof and is disclosed without any obligation to keep it confidential or any restriction on its use; or

11.2.4    is published by a Third Party or otherwise becomes publicly available or enters the public domain, either before or after it is disclosed to the receiving Party; or

11.2.5    has been independently developed by employees or contractors of the receiving Party or any of its Affiliates without the aid, application or use of Confidential Information of the disclosing Party.

11.3    Authorized Disclosure. The receiving Party may disclose Confidential Information belonging to the other Party to the extent (and only to the extent) such disclosure is reasonably necessary in the following instances:

11.3.1    filing or prosecuting Patents Rights as set forth in this Agreement;

11.3.2    Company’s (or its Affiliates’ or Sublicensees’) research, Development or Commercialization (including any import, manufacture, use, offer for sale, or sale) activities, including Company’s (or its Affiliates’ or Sublicensees’) regulatory filings, with respect to Licensed Compounds and/or Licensed Product, including any Approvals or applications therefor;

 

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11.3.3    prosecuting or defending litigation in relation to the BMS Patent Rights, BMS Platform Patent Rights, BMS Know-How or this Agreement, including responding to a subpoena in a Third Party litigation; provided it has used good faith and reasonable efforts to obtain a protective order for such Confidential Information;

11.3.4    subject to Section 11.4, complying with applicable Laws (including the rules and regulations of the Securities and Exchange Commission (including as part of a Company initial public offering) or any national securities exchange) and with judicial process, if in the reasonable opinion of the receiving Party’s counsel, such disclosure is necessary for such compliance; provided, however, that except where impracticable, the receiving Party shall give the disclosing Party reasonable advance notice of such disclosure requirement (which shall include a copy of any applicable subpoena or order) and shall afford the disclosing Party a reasonable opportunity to oppose, limit or secure confidential treatment for such required disclosure, and in the event of any such required disclosure, the receiving Party shall disclose only that portion of the Confidential Information of the disclosing Party that the receiving Party is legally required to disclose;

11.3.5    disclosure, in connection with the performance of this Agreement and solely on a “need to know basis”, to Affiliates, or to existing or potential Sublicensees or collaborators (including existing or potential co-marketing and co-promotion contractors), research collaborators, employees, consultants, or agents, each of whom prior to disclosure must be bound by written obligations of confidentiality and non-use no less restrictive than the obligations set forth in this Article 11; provided, however, that the receiving Party shall remain responsible for any failure by any Person who receives Confidential Information pursuant to this Article 11 to treat such Confidential Information as required under this Article 11; and

11.3.6    made by such Party to existing or potential acquirers or merger candidates; investment bankers; public and private sources of funding; existing or potential investors, venture capital firms or other financial institutions or investors for purposes of obtaining financing, provided that such Party has used good faith and reasonable efforts to secure an agreement from any such Third Party to be bound by obligations of confidentiality and restrictions on use of Confidential Information that are no less restrictive than the obligations in this Agreement (but of shorter duration if customary).

If and whenever any Confidential Information is disclosed in accordance with this Section 11.3, such disclosure shall not cause any such information to cease to be Confidential Information except to the extent that such disclosure results in a public disclosure of such information (otherwise than by breach of this Agreement).

11.4    Terms of this Agreement. The Parties acknowledge that the terms of this Agreement shall be treated as Confidential Information of both Parties. For the avoidance of doubt, this Section 11.4 shall in no way prevent a Party from disclosing the existence of this Agreement or any terms of this Agreement in order to seek legal advice whenever deemed appropriate by such Party or to enforce such Party’s rights under this Agreement, whether through arbitral proceedings, court proceedings or otherwise, or to defend itself against allegations or claims relating to this Agreement, or to comply with Laws (except as provided in Section 11.5 below) when advised by outside counsel that terms of the Agreement are required to be disclosed to comply with Laws.

 

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11.5    Securities Filings. Notwithstanding anything to the contrary in this Agreement, in the event either Party proposes to file with the Securities and Exchange Commission or the securities regulators of any state or other jurisdiction a registration statement or any other disclosure document which describes or refers to this Agreement under the Securities Act of 1933, as amended, the Securities Exchange Act, of 1934, as amended, any other applicable securities Law or the rules of any national securities exchange, the Party shall notify the other Party of such intention and shall use reasonable efforts to provide such other Party with a copy of relevant portions of the proposed filing not less than [***] prior to (but in no event later than [***] prior to) such filing (and any revisions to such portions of the proposed filing a reasonable time prior to the filing thereof), including any exhibits thereto relating to this Agreement, and shall use reasonable efforts to obtain confidential treatment of any information concerning this Agreement that such other Party requests be kept confidential, and shall only disclose Confidential Information which it is advised by counsel is legally required to be disclosed. No such notice shall be required under this Section 11.5 if the substance of the description of or reference to this Agreement contained in the proposed filing has been included in any previous filing made by the either Party hereunder or otherwise approved by the other Party.

11.6    Publication by Company. Company or its Affiliates or Sublicensees may publish or present data and/or results relating to a Licensed Compound or Licensed Product developed in the Field in scientific journals and/or at scientific conferences, provided that Company or its Affiliate or Sublicensee shall notify BMS at least [***] in advance of the intended submission for publication or presentation of any proposed abstract, manuscript or presentation which discloses Confidential Information of BMS or discloses a patentable invention in which BMS may have an ownership interest (such as a Joint Invention) by delivering a copy thereof to BMS. BMS shall have [***] from its receipt of any such abstract, manuscript or presentation in which to notify Company in writing of any specific, reasonable objections to the disclosure, based on concern regarding the specific disclosure of Confidential Information of BMS, and Company will delete any BMS Confidential Information if requested by BMS, and consider any other such objections in good faith, including whether it is necessary or advisable to delete any other information from such proposed publication. Once any such abstract or manuscript is accepted for publication, Company shall provide BMS with a copy of the final version of the manuscript or abstract. The contents of any publication or presentation that has been reviewed and approved by BMS may be re-released by Company without a requirement for reapproval; provided, however, that such re-release does not substantially change or expand the previously issued content. BMS shall not submit any publication or presentation relating to the Licensed Compounds or Licensed Products without Company’s prior written consent.

ARTICLE 12

INDEMNITY

12.1    Company Indemnity. Company shall indemnify, defend and hold harmless BMS and its Affiliates, and their respective officers, directors, employees, agents, licensors, and their respective successors, heirs and assigns and representatives, from and against any and all damages,

 

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liabilities, losses, costs and expenses (including reasonable legal expenses, costs of litigation and reasonable attorney’s fees) arising in connection with any claims, suits, proceedings, whether for money damages or equitable relief, of any kind brought by any Third Party (collectively “Losses and Claims”) and arising out of or relating to (a) the research, Development, Commercialization (including promotion, advertising, offering for sale, sale or other disposition), transfer, importation or exportation, manufacture, labeling, handling or storage, or use of, or exposure to, any Licensed Compound or any Licensed Product by or for Company or any of its Affiliates, Distributors, Sublicensees, agents and contractors, including claims and threatened claims based on product liability, bodily injury, risk of bodily injury, death or property damage, infringement or misappropriation of Third Party patents, copyrights, trademarks or other intellectual property rights (except to the extent such infringement or misappropriation results from a breach of Section 9.2.1), or the failure to comply with applicable Law related to the matters referred to in this subsection (a) with respect to any Licensed Compound or any Licensed Product, (b) the prosecution, maintenance, enforcement and defense of the BMS Patent Rights by Company, its Affiliates, Sublicensees, representatives and agents; and/or (c) the gross negligence, recklessness or willful misconduct of Company or its Affiliates or its or their respective directors, officers, employees and agents, in connection with Company’s performance of its obligations or exercise of its rights under this Agreement; except in any such case for Losses and Claims to the extent reasonably attributable to any material breach by BMS of Article 11, or BMS having committed an act or acts of gross negligence, recklessness or willful misconduct, or to the extent BMS has an indemnification obligation to Company pursuant to Section 12.2.

12.2    BMS Indemnity. BMS shall indemnify, defend and hold harmless Company and its Affiliates, and their respective officers, directors, employees, agents, licensors, and their respective successors, heirs and assigns and representatives, from and against any and all Losses payable to a Third Party based on Claims brought by a Third Party arising out of or relating to (a) a material breach by BMS of Article 11 or the representations, warranties and covenants of BMS set forth in Section 4.1 and/or Article 9, (b) the gross negligence, recklessness or willful misconduct of BMS or its Affiliates or its or their respective directors, officers, employees and agents, in connection with BMS’s performance of its obligations or exercise of its rights under this Agreement, and/or (c) any Development, use, manufacture, or Commercialization of BMS Reversion Products by BMS following the reversion thereof to BMS pursuant to Section 13.4 in the Territory, including any product liability claims in the Territory or any personal injury, property damage or other damage in the Territory arising therefrom; except in any such case for Losses and Claims to the extent reasonably attributable to any material breach by Company of Article 11 of this Agreement, failure of Company to comply with Laws with respect to its Development or Commercialization of the Licensed Compounds or Licensed Products, or Company having committed an act or acts of gross negligence, recklessness or willful misconduct, or to the extent Company has an indemnification obligation to BMS pursuant to Section 12.1.

12.3    Indemnification Procedure. A claim to which indemnification applies under Section 12.1 shall be referred to herein as an “Indemnification Claim”. If any Person or Persons (collectively, the “Indemnitee”) intends to claim indemnification under this Article 12, the Indemnitee shall notify the Party subject to the indemnification obligation (the “Indemnitor”) in writing promptly upon becoming aware of any claim that may be an Indemnification Claim (it being understood and agreed, however, that the failure by an Indemnitee to give such notice shall not relieve Indemnitor of its indemnification obligation under this Agreement except and only to

 

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the extent that the Indemnitor is actually prejudiced as a result of such failure to give notice). The Indemnitor shall have the right to assume and control the defense of the Indemnification Claim at its own expense with counsel selected by the Indemnitor and reasonably acceptable to the Indemnitee, provided, however, that an Indemnitee shall have the right to retain its own counsel, with the fees and expenses to be paid by the Indemnitee, if representation of such Indemnitee by the counsel retained by the Indemnitor would be inappropriate due to actual or potential differing interests between such Indemnitee and any other party represented by such counsel in such proceedings. If the Indemnitor does not assume the defense of the Indemnification Claim as aforesaid, the Indemnitee may defend the Indemnification Claim but shall have no obligation to do so. The Indemnitee shall not settle or compromise the Indemnification Claim without the prior written consent of the Indemnitor, and the Indemnitor shall not settle or compromise the Indemnification Claim in any manner which would have an adverse effect on the Indemnitee’s interests (including any rights under this Agreement or the scope or enforceability of the BMS Patents Rights or BMS Know-How), without the prior written consent of the Indemnitee, which consent, in each case, shall not be unreasonably withheld, delayed or conditioned if the settlement or compromise would impose no financial or other obligations or burdens on the Indemnitee. The Indemnitee shall reasonably cooperate with the Indemnitor at the Indemnitor’s expense and shall make available to the Indemnitor all pertinent information under the control of the Indemnitee, which information shall be subject to Article 11.

12.4    Insurance. Company shall, beginning with the initiation of the first clinical trial for a Licensed Product, maintain at all times thereafter during the term of this Agreement, and until the later of (i) [***] after termination or expiration of this Agreement or (ii) the date that all statutes of limitation covering claims or suits that may be brought for personal injury based on the sale or use of a Licensed Product have expired in all states in the U.S., insurance relating to the Licensed Product from a recognized, creditworthy insurance company, on a claims-made basis, with endorsements for contractual liability and for clinical trial and product liability, that is comparable in type and amount to the insurance customarily maintained by Company with respect to similar prescription pharmaceutical products that are marketed, distributed and sold in the Territory; provided that if Company does not market, distribute and sell any such similar pharmaceutical products, such insurance shall be comparable in type and amount to the insurance customarily maintained by a company within the biopharmaceutical industry. Within [***] following the Effective Date, and within [***] following any material change or cancellation in coverage, Company shall furnish to BMS a certificate of insurance evidencing such coverage as of such date, and in the case of cancellation, provide a certificate evidencing that Company’s replacement coverage meets the requirements in the first sentence of this Section 12.4. The foregoing insurance requirement shall not be construed to create a limit on the Company’s liability hereunder. For any Sublicensee that self-insures, or after a Change of Control of Company, if the Company acquirer self-insures, such self-insurance will be deemed to satisfy this Section 12.4, subject to BMS’s consent, such consent not to be unreasonably withheld, delayed or conditioned.

ARTICLE 13

TERM AND TERMINATION

13.1    Term. This Agreement shall commence as of the Effective Date and, unless sooner terminated in accordance with the terms hereof or by mutual written consent, shall expire on a country-by-country basis and Licensed Product-by-Licensed Product basis, upon the expiration of the Royalty Term with respect to a given Licensed Product in the applicable country.

 

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13.2    Termination by BMS. BMS shall have the right to terminate this Agreement, at BMS’ sole discretion, as follows:

13.2.1    Insolvency. To the extent permitted under applicable Laws, BMS shall have the right to terminate this Agreement in its entirety, at BMS’ sole discretion, upon delivery of written notice to Company upon the filing by Company in any court or agency pursuant to any statute or regulation of the United States or any other jurisdiction a petition in bankruptcy or insolvency or for reorganization or similar arrangement for the benefit of creditors or for the appointment of a receiver or trustee of Company or its assets, upon the proposal by Company of a written agreement of composition or extension of its debts, or if Company is served by a Third Party (and not by BMS) with an involuntary petition against it in any insolvency proceeding, upon the [***] after such service if such involuntary petition has not previously been stayed or dismissed, or upon the making by Company of an assignment for the benefit of its creditors.

13.2.2    Breach. BMS shall have the right to terminate this Agreement in its entirety, at BMS’ sole discretion, (x) as provided in Section 5.6 or (y) upon delivery of written notice to Company in the event of any material breach by Company of this Agreement (except that this Section 13.2.2 shall not apply to any breach of Sections 5.1 or 6.1, which are covered under Section 13.2.3), provided that such breach has not been cured within [***] after written notice is given by BMS to Company; provided, however, that if such breach relates to the failure to make a payment when due, such breach must be cured within [***] after written notice thereof is given by BMS (except that in the case of a bona fide dispute over whether or to what extent a payment by Company to BMS is due, this Section 13.2.2 shall not be triggered provided that Company shall pay the amount in dispute into escrow until such dispute is resolved). Any such termination of this Agreement shall become effective at the end of the applicable cure period, unless Company has cured any such breach or default prior to the expiration of such cure period.

13.2.3    Termination for Failure to Develop or Commercialize. BMS shall have the right to terminate this Agreement in its entirety in the event that Company fails to fulfill its obligations to Develop Licensed Compounds and/or Licensed Products in accordance with Section 5.1, or to Commercialize Licensed Products in accordance with Section 6.1, provided that (a) Company has not cured such breach within [***] following written notice by BMS which notice shall be labeled as a “notice of material breach for failure to use Commercially Reasonable Efforts,” and in the case of an alleged breach of Section 6.1, the Major Market Country(ies) in which such breach has occurred; provided further that if such breach is capable of being cured, but cannot be cured within such [***], and Company initiates actions to cure such breach within such period and thereafter diligently pursues such actions, Company shall have an additional [***] to cure such breach (or such longer period of time as may be agreed by the Parties). Any such termination of this Agreement shall become effective at the end of the applicable cure period, unless Company has cured any such breach or default prior to the expiration of such cure period.

 

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13.2.4    Termination for Patent Challenge.

(a)    BMS shall have the right to terminate this Agreement in its entirety in the event Company (or any of its Affiliates) challenges or knowingly supports (other than as may be necessary or reasonably required to assert a cross-claim or a counter-claim, or in response to a subpoena or court or administrative law request or order), including by providing information, documents, and/or funding, a challenge to the validity, scope, enforceability or patentability of any of the BMS Patent Rights or BMS Platform Patent Rights. BMS’s right to terminate this Agreement under this Section 13.2.4 may be exercised at any time after Company (or any of its Affiliates) may have challenged or knowingly supports (other than in response to a subpoena or court order) a challenge to the validity, scope, enforceability or patentability of any of the BMS Patent Rights or BMS Platform Patent Rights. For the avoidance of doubt, an action by Company or any Affiliate in accordance with Article 10 to amend claims within a pending patent application within the BMS Patent Rights during the course of Company’s prosecution and maintenance of such pending patent application or in defense of a Third Party proceeding, or to make a negative determination of patentability of claims of a patent application of BMS or to abandon a patent application of BMS during the course of Company’s prosecution and maintenance of such pending patent application, shall not, where undertaken in accordance with Article 9 hereof, constitute a challenge under this Section 13.2.4.

(b)    If a Sublicensee of Company challenges the validity, scope or enforceability of or otherwise opposes any of the BMS Patent Rights or BMS Platform Patent Rights under which such Sublicensee is sublicensed, then Company shall, at BMS’ election and upon written notice from BMS, promptly terminate such Sublicense. The Company shall include within each License Agreement with each Sublicensee a right on the part of the Company to terminate such License Agreement in the event such Sublicensee challenges or knowingly supports a Third Party in challenging (other than in response to a subpoena or court order), in a judicial or administrative proceeding, including without limitation by providing information, documents, or funding, the validity, scope or enforceability of any of the BMS Patent Rights or BMS Platform Patent Rights after grant of the patent and (ii) the Company shall exercise such right to terminate the License Agreement with a Sublicensee should such Sublicensee challenge or knowingly support a Third Party in challenging (other than in response to a subpoena or court order) in a judicial or administrative proceeding the validity or enforceability of any of the BMS Patent Rights or BMS Platform Patent Rights after grant of the patent. If Company fails to exercise such termination right against such Sublicensee or is unable to do so because it did not include such a provision in its Sublicense, BMS may terminate this Agreement.

13.3    Termination by Company. Company shall have the right to terminate this Agreement, at Company’s sole discretion, as follows.

13.3.1    Upon [***] prior written notice in the case where Approval has not been obtained for a Licensed Product or upon [***] prior written notice in the case where Approval has been obtained for a Licensed Product, such termination to be effective at the end of such notice period, Company may terminate this Agreement for any reason.

 

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13.3.2    Company may terminate this Agreement in the event of a material breach by BMS, provided that such breach has not been cured within [***] following written notice by Company. Any such termination of this Agreement shall become effective at the end of the applicable cure period, unless BMS has cured any such breach or default prior to the expiration of such cure period.

13.4    Effect of Termination. Upon termination of this Agreement in its entirety by BMS under Section 13.2 or by Company under Section 13.3.1:

13.4.1    All rights and licenses granted to Company in Article 2 shall terminate, all rights of Company under the BMS Patent Rights, BMS Platform Patent Rights and BMS Know-How shall revert to BMS, and Company and its Affiliates shall cease all use of the BMS Patent Rights, BMS Platform Patent Rights, the BMS Know-How and the Transferred Materials, and shall return to BMS all unused portions of the Transferred Materials, subject, in the case of termination pursuant to Section 13.3.1, to BMS’ reimbursement of Company’s actual costs incurred in transferring the Transferred Materials to BMS. Following the effective date of such termination, all Licensed Compounds and/or Licensed Products (save for any Combination Products) shall thereafter be deemed “BMS Reversion Products”. For clarity, with respect to any Combination Product, neither BMS nor any Third Party that controls an active ingredient (other than the Licensed Compound) that is contained in any Combination Product shall be deemed to have been granted a license hereunder to Develop or Commercialize any such Combination Product.

13.4.2    With respect to all regulatory filings (including all INDs and NDAs) and Approvals and all other regulatory documents necessary to further Develop and Commercialize the BMS Reversion Products, as they exist as of the date of such termination (and all of Company’s right, title and interest therein and thereto), BMS shall determine in its sole discretion which of these shall be (i) assigned to BMS, and Company shall provide to BMS one (1) copy of the applicable documents and filings, all documents and filings in Company’s possession or Control that are contained in or referenced in any such filings, together with the raw and summarized data for any preclinical and clinical studies of the BMS Reversion Products as well as any final documentation to inactivate any open INDs as BMS may elect to inactivate, subject, in the case of termination pursuant to Section 13.3.1, to BMS’ reimbursement of Company’s actual costs incurred in transferring such items to BMS, and preparing such items in connection with such transfer, or (ii) withdrawn or inactivated at Company’s expense. For clarity, BMS shall have the right to use the foregoing material information, materials and data developed by Company solely in connection with BMS’ development, manufacture and commercialization of BMS Reversion Products. BMS shall have the right to obtain specific performance of Company’s obligations referenced in this Section 13.4.2 and/or in the event of failure to obtain assignment, Company hereby consents and grants to BMS the right to access and reference (without any further action required on the part of Company, whose authorization to file this consent with any Regulatory Authority is hereby granted) any and all such regulatory filings for any regulatory or other use or purpose in the Territory. Without limiting the foregoing in this paragraph, to the extent applicable, Company’s obligations under Section 10.7 shall continue with respect to all countries in the Territory for which there is a failure to obtain assignment of all regulatory filings and Approvals.

 

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13.4.3    All amounts due or payable to BMS that were accrued prior to the effective date of termination shall remain due and payable; but (except as otherwise expressly provided herein) no additional amounts shall be payable based on events occurring after the effective date of termination; provided, that the foregoing shall not be deemed to limit Company’s indemnification obligations under this Agreement for acts or omissions incurring prior to the termination date that are the subject of such indemnification even if the indemnification amount cannot be accrued or determined as of the termination date.

13.4.4    BMS shall have the right to retain all amounts previously paid to BMS by Company.

13.4.5    Should Company have any inventory of any Licensed Compound included in the BMS Reversion Products suitable for use in clinical trials, Company shall offer to sell such Licensed Compound to BMS at the fully burdened manufacturing cost of such Licensed Compound (but BMS shall be under no obligation to purchase same unless it agrees to do so in writing at such time).

13.4.6    Should Company have any inventory of any Licensed Product included in the BMS Reversion Products approved and allocated prior to termination, Company shall have [***] thereafter in which to dispose of such inventory (subject to the payment to BMS of any royalties due hereunder thereon) (the “Inventory Disposal Period”), provided however, that (i) such right shall terminate at such time that BMS purchases all remaining stocks of inventory of such BMS Reversion Product as described in this Section 13.4.6, below, and (ii) such Licensed Product shall not be sold at a discount to a purchaser that is greater than the average discount provided to such purchaser for the Licensed Product in the applicable country during the [***] period preceding such termination and, in addition, such sales shall not result in the applicable wholesaler inventory levels for such Licensed Product exceeding the average levels for the [***] period preceding such termination. Notwithstanding the foregoing, if BMS takes over responsibility for sale of the BMS Reversion Products in any country in the Territory prior to the end of the Inventory Disposal Period, BMS shall be required to purchase all remaining stocks of saleable inventory that meets BMS specifications and return policies of such BMS Reversion Product at Company’s cost of goods sold for such BMS Reversion Product, as accounted for in the Company’s audited financial statements.

13.4.7    Company shall provide to BMS the tangible embodiments of all Know-How Controlled by Company and its Affiliates to the extent necessary for the Development and Commercialization of the BMS Reversion Products in existence as of the date of such termination, subject, in the case of termination pursuant to Section 13.3.1, to BMS’ reimbursement of Company’s actual costs and expense incurred in transferring such items, and preparing and making such items in connection with such transfer (without duplicating any amounts reimbursed pursuant to Sections 13.4.2 and 13.4.10), including Company’s manufacturing processes, techniques and trade secrets for making such BMS

 

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Reversion Products and all Know-How specifically relating to any composition, formulation, method of use or manufacture of such BMS Reversion Products, and BMS shall automatically have a perpetual, worldwide, transferable, sublicensable right and license under such Know-How solely for (a) researching, Developing, using, importing, selling and offering for sale BMS Reversion Products in the Territory, which license shall be exclusive for purposes of this subpart (a), and (b) making and having made BMS Reversion Products anywhere in the Territory for use, importation, sale and offer for sale in the Territory, which license shall be non-exclusive for purposes of this subpart (b); provided that Company shall assign (or, if applicable, cause its Affiliate to assign) to BMS all of Company’s (and such Affiliate’s) entire right, title and interest in and to all data generated by Company (or its Affiliate) under this Agreement solely to the extent necessary for the development and/or commercialization of the relevant BMS Reversion Products. Company shall reasonably cooperate with BMS to assist BMS with understanding and using the Know-How provided to BMS under this Section 13.4.7. Such cooperation shall include providing BMS with reasonable access by teleconference or in-person at Company’s facilities (subject to Company’s customary rules and restrictions with respect to site visits by non-Company personnel and subject, in the case of termination pursuant to Section 13.2.1, to BMS’ reimbursement of Company’s actual out-of-pocket costs and expense incurred in connection with such cooperation).

13.4.8    To the extent that Company owns any trademark(s) and/or domain names that pertain specifically to an BMS Reversion Product that BMS believes would be necessary for the Commercialization of a BMS Reversion Product (as then currently marketed, but not including any marks that include, in whole or part, any corporate name or logo of Company), Company shall assign (or, if applicable, cause its Affiliate to assign) to BMS all of Company’s (and such Affiliate’s) right, title, good will, and interest in and to any registered or unregistered trademark, trademark application, trade name or internet domain name in each terminated country.

13.4.9    Company shall grant and hereby grants to BMS an exclusive, royalty-bearing (solely to the extent set forth in Section 13.4.11), non-transferable (except as provided in Section 15.4) license, with the right to grant sublicenses, under (a) any Patent Rights Controlled by Company or its Affiliates as at the effective date of termination and (b) all Patent Rights Controlled by Company or its Affiliates after the date of such termination claiming any invention conceived or reduced to practice or applied by or on behalf of Company in furtherance of the Development of Commercialization of a Licensed Compound or Licensed Product during the term of this Agreement, in each case of (a) and (b) to the extent covering the composition of matter, use, or manufacture of BMS Reversion Products (solely to the extent actually practiced in connection with the BMS Reversion Products as of such termination effective date) and that, in each case of (a) and (b), are necessary to develop, manufacture or commercialize BMS Reversion Products.

13.4.10    Neither Party shall be relieved of any obligation that accrued prior to the effective date of such termination.

13.4.11    BMS shall pay Company a royalty equal to [***] of net sales of such BMS Reversion Product in the applicable terminated country by BMS or BMS’

 

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Affiliates, licensees or sublicensees, provided that such termination occurs any time after a Phase 2 Trial has been initiated for such BMS Reversion Product. For purposes of this Section 13.14.11, “net sales” shall be calculated in the same manner Net Sales are defined for sales made by Company, substituting “BMS, its Affiliates and (sub)licensees” for each reference to a Related Party in such Section.

13.4.12    Any costs and expenses incurred by Company in connection with the assignments and transfers made by Company under this Section 13.4 shall be borne by Company unless BMS terminates this Agreement under Section 13.2.1, in which case such costs and expenses shall be reimbursed by BMS.

13.4.13    It is understood and agreed that BMS shall be entitled to seek specific performance as a remedy to enforce the provisions of this Section 13.4, in addition to any other remedy to which it may be entitled by applicable Law.

13.4.14    If Company has the capability in place as of the date of such termination to commercially manufacture and supply to BMS all or part of BMS’ requirements of the applicable BMS Reversion Products for use and sale in the Territory, if BMS so elects in its sole discretion, Company shall supply to BMS for a period not to exceed [***] (with the period of time being within the sole discretion of BMS) as much of BMS’ requirements of such BMS Reversion Products as possible for use and sale in the Territory, at a price equal to [***] of Company’s documented fully-burdened manufacturing cost (determined in accordance with GAAP) for such BMS Reversion Products, under terms and conditions as may be mutually agreed between the Parties. In the event that Company has, prior to the date of such termination, engaged a Third Party to manufacture and supply any BMS Reversion Products, Company shall use reasonable efforts, at BMS’ sole cost and expense, to assist in the transfer of such supply arrangements to BMS. In the event that BMS terminates this Agreement under Section 13.2, Company shall supply BMS’ requirements of all such BMS Reversion Products in quantities manufactured for and supplied to Company by such Third Party for a period not to exceed [***] (with the period of time being within the sole discretion of BMS) as much of BMS’ requirements of such BMS Reversion Products as possible (not to exceed amounts needed by Company for Development and/or Commercialization by Company); provided however, if there are restrictions in the agreement between Company and such Third Party governing the manufacture and supply of such BMS Reversion Products that would preclude the period from being up to [***], then such period shall be up to as long a time as permitted under such agreement. Where Company has engaged a Third Party to manufacture and supply any BMS Reversion Products to Company and BMS elects to have Company supply any portion of BMS’ requirements of such BMS Reversion Products, then Company shall supply such BMS Reversion Products at a price equal to [***] of the cost paid by Company to such Third Party plus Company’s shipping, handling, including other reasonable costs associated with providing such BMS Reversion Products to BMS.

13.4.15    Nothing in this Section 13.4 shall be deemed to limit any remedy to which either Party may be entitled by applicable Law.

 

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13.5    Effect of Termination by Company for Breach by BMS. Upon termination of this Agreement by Company pursuant to Section 13.3.2:

13.5.1    All rights and licenses granted to Company in Article 2 shall terminate, all rights of Company under the BMS Patent Rights, BMS Platform Patent Rights and BMS Know-How shall revert to BMS, and Company and its Affiliates shall cease all use of the BMS Patent Rights, BMS Platform Patent Rights, the BMS Know-How and the Transferred Materials, and shall return to BMS all unused portions of the Transferred Materials.

13.5.2    All amounts due or payable to BMS that were accrued, or that arise out of acts or events occurring, prior to the effective date of termination or expiration shall remain due and payable; but (except as otherwise expressly provided herein) no additional amounts shall be payable based on events occurring after the effective date of termination or expiration.

13.5.3    BMS shall have the right to retain all amounts previously paid to BMS by Company.

13.5.4    Should Company have any inventory of any Licensed Product approved and allocated prior to termination for sale in a terminated country, Company shall have [***] thereafter in which to dispose of such inventory (subject to the payment to BMS of any royalties due hereunder thereon).

13.5.5    Neither Party shall be relieved of any obligation that accrued prior to the effective date of such termination or expiration.

13.5.6    Nothing in this Section 13.5 shall be deemed to limit any remedy to which Company may be entitled by applicable Law.

13.6    Effect of Expiration of this Agreement. Upon expiration of this Agreement:

13.6.1    All amounts due or payable to BMS that were accrued, or that arise out of acts or events occurring, prior to the effective date of expiration shall remain due and payable; but (except as otherwise expressly provided herein) no additional amounts shall be payable based on events occurring after the effective date of expiration.

13.6.2    BMS shall have the right to retain all amounts previously paid to BMS by Company.

13.6.3    Neither Party shall be relieved of any obligation that accrued prior to the effective date of expiration.

13.6.4    The license with respect to BMS Patent Rights, BMS Platform Patent Rights and BMS Know-How granted under Section 2.1 shall remain in effect and shall be perpetual, irrevocable, royalty-free and fully paid-up.

 

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13.7    Scope of Termination. Termination of this Agreement shall be as to all countries in the Territory and all Licensed Compounds and all Licensed Products.

13.8    Survival. The following provisions shall survive termination or expiration of this Agreement, as well as any other provisions which by their nature are intended to survive termination: Article 1 (as applicable), Section 2.2.1(g), Section 2.4, Section 4.1(except for the first sentence), Sections 8.6 through 8.10 (for three (3) years after the end of the Calendar Year in which this Agreement was terminated), Section 9.4, Section 9.5, Section 10.1, Section 10.4 (with respect to an action, suit or proceeding commenced prior to termination), Section 10.9, Article 11, Article 12, whichever one of Sections 13.4, 13.5 or 13.6 applies, this Section 13.8, Section 13.10, Article 14 and Article 15.

13.9    Bankruptcy. The Parties agree that in the event a Party becomes a debtor under Title 11 of the U.S. Code (“Title 11”), this Agreement shall be deemed to be, for purposes of Section 365(n) of Title 11, a license to rights to “intellectual property” as defined therein. Each Party as a licensee hereunder shall have the rights and elections as specified in Title 11. Any agreements supplemental hereto shall be deemed to be “agreements supplementary to” this Agreement for purposes of Section 365(n) of Title 11.

13.10    No Limitation of Remedies. Except as herein expressly provided, notwithstanding anything to the contrary in this Agreement, except as otherwise set forth in this Agreement, termination or expiration of this Agreement shall not relieve the Parties of any liability or obligation which accrued hereunder prior to the effective date of such termination or expiration nor prejudice either Party’s right to obtain performance of any obligation. Each Party shall be free, pursuant to Article 14, to seek (without restriction as to the number of times it may seek) damages, costs and remedies that may be available under applicable Law or in equity and shall be entitled to offset the amount of any damages and costs obtained in a final determination under Article 14 of monetary damages or costs (as permitted by this Agreement) against the other Party against any amounts otherwise due to such other Party under this Agreement.

ARTICLE 14

DISPUTE RESOLUTION

14.1    Resolution by Senior Executives. Except as provided in Sections 8.7 and 14.3, in the event of any dispute between the Parties in connection with this Agreement, the construction hereof, or the rights, duties or liabilities of either Party hereunder, including any disagreement as to whether there has been a material breach of this Agreement pursuant to Sections 13.2.2, 13.2.3, or 13.3.2, the Parties shall first attempt in good faith to resolve such dispute by negotiation and consultation between themselves. In the event that such dispute is not resolved on an informal basis within [***], either Party may, by written notice to the other Party, refer the dispute to (i) the Chief Executive Officer of Company and (ii) if a scientific matter, [***] or, if a commercial matter, [***] for attempted resolution by good faith negotiation within [***] after such notice is received; provided, however, such executive officers of Company and BMS may each designate a senior manager to whom such dispute is delegated instead for such attempted resolution.

 

54


14.2    Remedies. Except as provided in Sections 8.7 and 14.3, if any dispute between the Parties relating to or arising out this Agreement cannot be resolved in accordance with Section 14.1, each Party shall be free to pursue any or all available remedies at law or in equity, consistent with Section 15.8.

14.3    Injunctive Relief. Notwithstanding anything in this Article 14, each Party shall have the right to seek injunctive or other equitable relief from a court of competent jurisdiction pursuant to Section 15.8 that may be necessary to avoid irreparable harm, maintain the status quo or preserve the subject matter of the dispute, including any breach or threatened breach of Article 11.

14.4    Tolling. The Parties agree that all applicable statutes of limitation and time-based defenses (such as estoppel and laches), as well as all time periods in which a Party must exercise rights or perform obligation hereunder, will be tolled once the dispute resolution procedures set forth in this ARTICLE 14 and Section 15.8 have been initiated and for so long as they are pending, and the Parties will cooperate in taking all actions reasonably necessary to achieve such a result. In addition, during the pendency of any dispute under this Agreement initiated before the end of any applicable cure period, including under Section 13.2.2, 13.2.3, 13.2.4 or 13.3.2, (a) this Agreement will remain in full force and effect, (b) the provisions of this Agreement relating to termination for material breach with respect to such dispute will not be effective, (c) the time periods for any applicable cure period as to any termination notice given prior to the initiation of any action, suit or proceeding will be tolled, (d) any time periods to exercise rights or perform obligations will be tolled; and (e) neither Party will issue a notice of termination pursuant to this Agreement based on the subject matter of the action, suit or proceeding, in each case ((a) – (e)), until the relevant court has confirmed the material breach and the existence of the facts claimed by a Party to be the basis for the asserted material breach; provided that if such breach can be cured by (i) the payment of money, then the defaulting Party will have an additional [***] after its receipt of the court’s decision to pay such amount, or (ii) the taking of specific remedial actions, the defaulting Party will have a reasonably necessary period to diligently undertake and complete such remedial actions within such reasonably necessary period or any specific timeframe established by such court’s decision before any such notice of termination can be issued. Further, with respect to any time periods that have run during the pendency of the dispute, the applicable Party will have a reasonable period of time or any specific timeframe established by such court’s decision to exercise any rights or perform any obligations affected by the running of such time periods. For clarity, the periods described in clauses ((a)-(e)) above shall not be further tolled in the event of a dispute as to whether a cure that has been completed, and the terminating Party shall have the right to terminate in accordance with the terms of this Agreement.

ARTICLE 15

MISCELLANEOUS

15.1    Severability. If any one or more of the provisions of this Agreement is held to be invalid or unenforceable, the provision shall be considered severed from this Agreement and shall not serve to invalidate any remaining provisions hereof. The Parties shall make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement with respect to such provision may be realized.

 

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15.2    Notices. Any notice required or permitted to be given by this Agreement shall be in writing and shall be delivered by hand or overnight courier with tracking capabilities or mailed postage prepaid by first class, registered or certified mail, return receipt requested and addressed as set forth below unless changed by notice so given:

If to Company:

AdMIRx Inc.

LabCentral, 700 Main Street, North

Cambridge, MA 02139

Attention: Chief Executive Officer

With a copy to:

Goodwin Procter LLP

100 Northern Avenue

Boston, MA 02210

Attention: Kingsley L. Taft, Esq.

If to BMS:

Bristol-Myers Squibb Company

P.O. Box 4000

Route 206 & Province Line Road

Princeton, New Jersey 08543-4000

Attention: Vice President, Business Development

With a copy to:

Bristol-Myers Squibb Company

P.O. Box 4000

Route 206 & Province Line Road

Princeton, New Jersey 08543-4000

Attention: Vice President & Assistant General Counsel, Business Development and Licensing

Bristol-Myers Squibb Company

P.O. Box 4000

Route 206 & Province Line Road

Princeton, New Jersey 08543-4000

Attention: Vice President, Research Collaborations

Any such notice shall be deemed delivered on the date received. A Party may add, delete, or change the person or address to whom notices should be sent at any time upon written notice delivered to the Party’s notices in accordance with this Section 15.2.

15.3    Force Majeure. Neither Party shall be liable for delay or failure in the performance of any of its obligations hereunder if such delay or failure is due to causes beyond its reasonable control, including acts of God, fires, earthquakes, strikes and labor disputes, acts of war, terrorism, civil unrest or intervention of any governmental authority (“Force Majeure”); provided, however, that the affected Party promptly notifies the other Party and further provided that the affected Party

 

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shall use Commercially Reasonable Efforts to avoid or remove such causes of non-performance and to mitigate the effect of such occurrence, and shall continue performance with the utmost dispatch whenever such causes are removed. When such circumstances arise, the Parties shall negotiate in good faith any modifications of the terms of this Agreement that may be necessary or appropriate in order to arrive at an equitable solution.

15.4    Assignment.

15.4.1    BMS may, without Company’s consent, (x) assign, delegate or transfer some or all of its rights and obligations hereunder to any Affiliate of BMS, and (y) assign or transfer all of this Agreement, in connection with any transfer or assignment of all of the BMS Patent Rights, BMS Platform Patent Rights and BMS Know-How, to any Third Party (including a successor in interest by reason of merger, consolidation or sale of substantially all of the assets of BMS to which this Agreement relates).

15.4.2    Company may assign or transfer all of its rights and obligations hereunder without BMS’s consent to an Affiliate of Company or a successor in interest by reason of merger, consolidation or sale of substantially all of the assets of Company to which this Agreement or other Change of Control (and so long as such assignment or transfer includes, without limitation, all Approvals, assignment or license or access to all manufacturing assets relating to this Agreement, and all rights and obligations under this Agreement); provided, however, that such Affiliate or successor in interest shall have agreed prior to or as of such assignment or transfer to be bound by the terms of this Agreement in a writing provided to BMS.

15.4.3    Subject to the foregoing, this Agreement shall inure to the benefit of, and be binding on, the Parties’ permitted successors and assigns. Any assignment or transfer in violation of the foregoing shall be null and void and wholly invalid, the assignee or transferee in any such assignment or transfer shall acquire no rights whatsoever, and the non-assigning, non-transferring Party shall not recognize, nor shall it be required to recognize, such assignment or transfer.

15.4.4    In the event that BMS assigns, delegates or otherwise transfers this Agreement, in whole or in part, to an Affiliate of BMS, BMS hereby agrees to be jointly and severally liable with any such Affiliates for the actions of such Affiliates and for any and all amounts that become due and payable hereunder to Company. In the event that Company assigns or otherwise transfers or assigns this Agreement to an Affiliate of Company, Company hereby agrees to be jointly and severally liable with any such Affiliates for the actions of such Affiliates and for any and all amounts that become due and payable hereunder to BMS.

15.4.5    Notwithstanding anything to the contrary in this Agreement, in the event of any such transfer or assignment to a Third Party (including a successor in interest by reason of merger, consolidation or sale of assets or other Change of Control permitted), the intellectual property rights of the acquiring party (if other than one of the Parties) or the acquired Party (if acquired by a Party or its Affiliates) shall not be included in the technology licensed to the other Party hereunder to the extent (x) held by such Party that

 

57


is acquired or is acquiring a Third Party prior to such transaction, or (y) such technology is developed thereafter outside the scope of activities conducted with respect to the Licensed Compounds or Licensed Products.

15.5    Further Assurances. Each Party agrees to do and perform all such further acts and things and shall execute and deliver such other agreements, certificates, instruments and documents necessary or that the other Party may deem advisable in order to carry out the intent and accomplish the purposes of this Agreement and to evidence, perfect or otherwise confirm its rights hereunder.

15.6    Waivers and Modifications. The failure of any Party to insist on the performance of any obligation hereunder shall not be deemed to be a waiver of such obligation. Waiver of any breach of any provision hereof shall not be deemed to be a waiver of any other breach of such provision or any other provision on such occasion or any succeeding occasion. No waiver, modification, release or amendment of any obligation under or provision of this Agreement shall be valid or effective unless in writing and signed by each of the Parties.

15.7    Choice of Law. This Agreement shall be governed by, enforced, and shall be construed in accordance with the laws of the State of New York without regard to its conflicts of law provisions (other than section 5-1401 of the New York General Obligations Law).

15.8    Jurisdiction. Each Party irrevocably submits to the exclusive jurisdiction of (i) the Supreme Court of the State of New York, New York County, and (ii) the United States District Court for the Southern District of New York, for the purposes of any suit, action or other proceeding arising out of this Agreement or out of any transaction contemplated hereby. Each Party agrees to commence any such action, suit or proceeding either in the United States District Court for the Southern District of New York or if such suit, action or other proceeding may not be brought in such court for jurisdictional reasons, in the Supreme Court of the State of New York, New York County. Each Party irrevocably and unconditionally waives any objection to the laying of venue of any action, suit or proceeding arising out of this Agreement or the transactions contemplated hereby in (i) the Supreme Court of the State of New York, New York County or (ii) the United States District Court for the Southern District of New York, and hereby and thereby further irrevocably and unconditionally waives and agrees not to plead or claim in any such court that any such action, suit or proceeding brought in any such court has been brought in an inconvenient forum.

15.9    Publicity. Each Party agrees not to issue press release or other public statement disclosing other information relating to this Agreement or the transactions contemplated hereby without the prior written consent of the other Party, such consent not to be unreasonably withheld, delayed or conditioned, provided, however, that any disclosure which is required by Law or the rules of a securities exchange, as reasonably advised by the disclosing Party’s outside counsel is allowed, and provided, further, that Company may from time to time issue public statements relating to the ongoing Development and/or Commercialization of Licensed Compounds and/or Licensed Products (excluding disclosure of the financial terms of this Agreement) pursuant to this Agreement without the prior written consent of BMS. The Parties agree that any such required disclosure shall not contain confidential business or technical information that is Confidential Information of BMS and, if disclosure of confidential business or technical information is required

 

58


by Law, the Parties shall use appropriate diligent efforts to minimize such disclosure and obtain confidential treatment for any such information which is disclosed to a governmental agency. Each Party agrees to provide to the other Party a copy of any public announcement regarding this Agreement or the subject matter thereof as soon as reasonably practicable under the circumstances prior to its scheduled release. Except under extraordinary circumstances, each Party shall provide the other with an advance copy of any such announcement at least [***] prior to its scheduled release. Each Party shall have the right to expeditiously review and recommend changes to any such announcement and, except as otherwise required by Law, the Party whose announcement has been reviewed shall remove any information the reviewing Party reasonably deems to be inappropriate for disclosure. The contents of any announcement or similar publicity which has been reviewed and approved by the reviewing Party can be re-released by either Party without a requirement for re-approval. This Section 15.9 is subject to the disclosure processes, exceptions and other terms and conditions in Article 11.

15.10    Relationship of the Parties. Each Party is an independent contractor under this Agreement. Nothing contained herein is intended or is to be construed so as to constitute BMS and Company as partners, agents or joint venturers. Neither Party shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement or undertaking with any Third Party.

15.11    Headings. Headings and captions are for convenience only and are not be used in the interpretation of this Agreement.

15.12    Entire Agreement. This Agreement constitutes the entire agreement between the Parties as to the subject matter of this Agreement, and supersedes and merges all prior negotiations, representations, agreements and understandings regarding the same.

15.13    Counterparts; Electronic Delivery. This Agreement may be executed in counterparts with the same effect as if both Parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together and shall constitute one and the same instrument. Signatures to this Agreement transmitted by email in “portable document format” (“.pdf”), or by any other electronic means intended to preserve the original graphic and pictorial appearance of this Agreement shall have the same effect as physical delivery of the paper document bearing original signature.

15.14    Performance by Affiliates. Each Party recognizes that the other Party may perform some or all of its obligations under this Agreement through Affiliates to the extent not prohibited under this Agreement; provided, however, that such other Party shall remain responsible for the performance by its Affiliates as if such obligations were performed by such other Party.

15.15    Exports. Company agrees not to export or re-export, directly or indirectly, any information, technical data, the direct product of such data, samples or equipment received or generated under this Agreement in violation of any applicable export control Laws.

15.16    Interpretation.

15.16.1    Each of the Parties acknowledges and agrees that this Agreement has been diligently reviewed by and negotiated by and between them, that in such

 

59


negotiations each of them has been represented by competent counsel and that the final agreement contained herein, including the language whereby it has been expressed, represents the joint efforts of the Parties and their counsel. Accordingly, in interpreting this Agreement or any provision hereof, no presumption shall apply against any Party as being responsible for the wording or drafting of this Agreement or any such provision, and ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision.

15.16.2    The definitions of the terms herein shall apply equally to the singular and plural forms of the terms defined. Whenever the context may require, any pronoun shall include the corresponding masculine, feminine and neuter forms. The words “include”, “includes” and “including” shall be deemed to be followed by the phrase “without limitation”. The word “will” shall be construed to have the same meaning and effect as the word “shall”. The word “any” shall mean “any and all” unless otherwise clearly indicated by context.

15.16.3    Unless the context requires otherwise, (a) any definition of or reference to any agreement, instrument or other document herein shall be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein or therein), (b) any reference to any Laws herein shall be construed as referring to such Laws as from time to time enacted, repealed or amended, (c) any reference herein to any Person shall be construed to include the Person’s successors and assigns, (d) the words “herein”, “hereof” and “hereunder”, and words of similar import, shall be construed to refer to this Agreement in its entirety and not to any particular provision hereof, (e) all references herein to Articles, Sections or Appendices, unless otherwise specifically provided, shall be construed to refer to Articles, Sections and Appendices of this Agreement; and (f) the term “and/or” in a sentence shall be construed such that the phrase “X and/or Y” means “X or Y, or both X and Y”.

15.16.4    This Agreement should be interpreted in its entirety and the fact that certain provisions of this Agreement may be cross-referenced in a Section shall not be deemed or construed to limit the application of other provisions of this Agreement to such Section and vice versa.

***

[SIGNATURE PAGE FOLLOWS]

 

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IN WITNESS WHEREOF, the Parties have cause this Agreement to be executed by their respective duly authorized officers.

 

ADMIRX INC.
By:   /s/ David Grayzel
  (Signature)
Name:   David Grayzel
Title:   Chairman, Board of Directors
Date:   September 13, 2019

 

BRISTOL-MYERS SQUIBB COMPANY
By:   /s/ Arthur Bertelson
  (Signature)
Name:   Arthur H. Bertelson
Title:   VP, Research Collaborations
Date:   September 14, 2019

 

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Appendix 1

BMS Patent Rights

[Intentionally Omitted]

 

62


Appendix 2

Initial Development Plan

[Intentionally Omitted]

 

63


Appendix 3

Licensed Compound

[Intentionally Omitted]

 

64


Appendix 4

Transferred Materials to be provided by BMS

[Intentionally Omitted]

 

65


Appendix 5

Documentation to be provided

[Intentionally Omitted]

 

66


Appendix 6

Pro Forma Capitalization Table

[Intentionally Omitted]

 

67


Appendix 7

Joinder

[Intentionally Omitted]

 

68


Appendix 8

Investors’ Rights Agreement and Voting Agreement

[Intentionally Omitted]

 

69

Exhibit 10.44

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

AMENDMENT 1 TO

LICENSE AGREEMENT

This Amendment 1 (“Amendment”), effective as of August 13, 2021 (“Amendment Effective Date”), amends the License Agreement (the “Agreement”) dated September 14, 2019, between Q32 Bio Inc. (formerly AdMIRx Inc.), a Delaware corporation with its principal place of business at One Broadway, 11th Floor, Cambridge, MA 02142 (“Company”) and Bristol-Myers Squibb Company (“BMS”), each referred to herein individually as a “Party” and collectively as the “Parties”.

The Parties have entered into the Agreement and now wish to amend it as set forth below.

For good and valuable consideration, the sufficiency of which is hereby acknowledged, the Parties agree as follows.

 

1.

Article 3, “Transfer of Know-How, Technical Assistance” shall be modified to extend the transfer period (Section 3.1) for Know-How and related documentation from BMS to Company starting on the Effective Date of the Agreement through December 31, 2021. In addition, the technical assistance period (Section 3.2) shall be extended through December 31, 2021, where BMS shall reasonably cooperate with Company to assist Company with understanding and using the Know-How provided to Company under Section 3.1.

 

2.

Appendix 4 shall be modified to add surrogate [***] IL-7R [***] to the list of transferred materials from BMS to Company.

 

3.

All other terms and conditions of the Agreement are unchanged.

IN WITNESS WHEREOF, the Parties through their duly authorized representatives have entered into this Amendment upon the Amendment Effective Date.

 

Q32 Bio Inc.     Bristol-Myers Squibb Company
By:  

/s/ Michael Broxson

    By:  

/s/ Janeen Doyle

Name:   Michael Broxson     Name:   Janeen Doyle
Title:   CEO     Title: Vice President, Research & Early Development Alliances Strategy & Business Development
Date:   August 30, 2021     Date:   September 2, 2021

Exhibit 10.45

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

SECOND AMENDMENT TO LICENSE AGREEMENT

This SECOND AMENDMENT TO LICENSE AGREEMENT (this “Amendment”), is effective as of the date signed by the last Party to sign below (the “Amendment Effective Date”), and is made by and between Bristol-Myers Squibb Company (“BMS”), and Q32 Bio Inc. (the “Company”). BMS and the Company may each be referred to herein as a “Party” or collectively as the “Parties”.

WHEREAS, AdMIRx Inc. and BMS entered into that certain License Agreement, dated as of September 14, 2019 (as amended to date, the “License Agreement”);

WHEREAS, AdMIRx Inc. changed its name to Q32 Bio Inc. on March 20, 2020;

WHEREAS, pursuant to Section 15.16 of the License Agreement, no waiver, modification, release or amendment of any obligation under the License Agreement shall be valid or effective unless in writing and signed by the Company and BMS; and

WHEREAS, the Company desires to enter into a partnering, collaboration, or acquisition agreement with a third party with respect to the program covered by the License Agreement, and to facilitate the Company’s entry into such agreement, the Company and BMS desire to agree to the waiver and amendment to the License Agreement set forth in this Amendment.

NOW, THEREFORE in consideration of the foregoing and the mutual agreements set forth below and other good and valuable consideration, the Parties agree as follows:

 

  1.

Capitalized terms used and not otherwise defined herein shall have the meanings given to such terms in the License Agreement.

 

  2.

BMS hereby irrevocably waives any and all rights set forth in Sections 5.7.1 and 5.7.2 of the License Agreement with respect to any ROFN in Sections 5.7.1 and 5.7.2 of the License Agreement and the License Agreement is hereby amended to terminate Section 5.7 of the License Agreement in its entirety.

 

  3.

Except to the extent waived or amended by this Amendment, the terms and provisions of the License Agreement shall remain in full force and effect.

 

  4.

This Amendment shall be governed by, enforced, and shall be construed in accordance with the laws of the State of New York without regard to its conflicts of law provisions (other than section 5-1401 of the New York General Obligations Law).

 

  5.

This Amendment may be executed in counterparts with the same effect as if both Parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together and shall constitute one and the same instrument. Signatures to this Amendment transmitted by email in “portable document format” (“.pdf”), or by any other


  electronic means intended to preserve the original graphic and pictorial appearance of this Amendment shall have the same effect as physical delivery of the paper document bearing original signature.

 

2


IN WITNESS WHEREOF, the Parties have caused this Amendment to be executed by their respective duly authorized officers as of the Amendment Effective Date.

 

Q32 BIO INC.
By:  

/s/ Michael Broxson

  (Signature)
Name:   Michael Broxson
Title:   CEO
Date:   July 26, 2022

 

BRISTOL-MYERS SQUIBB COMPANY
By:  

/s/ Robert Plenge

  (Signature)
Name:   Robert Plenge
Title:   SVP
Date:   July 26, 2022

 

3

Exhibit 10.46

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

THIRD AMENDMENT TO LICENSE AGREEMENT

This THIRD AMENDMENT TO LICENSE AGREEMENT (this “Amendment”), is effective as of the date signed by the last Party to sign below (the “Amendment Effective Date”), and is made by and between Bristol-Myers Squibb Company (“BMS”), and Q32 Bio Inc. (the “Company”). BMS and the Company may each be referred to herein as a “Party” or collectively as the “Parties”.

WHEREAS, AdMIRx Inc. and BMS entered into that certain License Agreement, dated as of September 14, 2019 (as amended to date, the “License Agreement”);

WHEREAS, AdMIRx Inc. changed its name to Q32 Bio Inc. on March 20, 2020;

WHEREAS, pursuant to Section 15.16 of the License Agreement, no waiver, modification, release or amendment of any obligation under the License Agreement shall be valid or effective unless in writing and signed by the Company and BMS; and

WHEREAS, the Company desires to enter into a partnering, collaboration, or acquisition agreement with a third party with respect to the program covered by the License Agreement, and to facilitate the Company’s entry into such agreement, the Company and BMS desire to agree to the amendment to the License Agreement set forth in this Amendment.

NOW, THEREFORE in consideration of the foregoing and the mutual agreements set forth below and other good and valuable consideration, the Parties agree as follows:

 

  1.

Capitalized terms used and not otherwise defined herein shall have the meanings given to such terms in the License Agreement.

 

  2.

Section 8.2.1 of the License Agreement is hereby amended by adding the following sentence to the end of Section 8.2.1:

“Notwithstanding the foregoing in this Section 8.2.1, in the event the [***] milestone event is achieved prior to [***], the payment to BMS of the [***] milestone payment for the achievement of the [***] for the [***] milestone event will be deferred until [***].”

 

  3.

Except to the extent waived or amended by this Amendment, the terms and provisions of the License Agreement shall remain in full force and effect.

 

  4.

This Amendment shall be governed by, enforced, and shall be construed in accordance with the laws of the State of New York without regard to its conflicts of law provisions (other than section 5-1401 of the New York General Obligations Law).

 

1


  5.

This Amendment may be executed in counterparts with the same effect as if both Parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together and shall constitute one and the same instrument. Signatures to this Amendment transmitted by email in “portable document format” (“.pdf”), or by any other electronic means intended to preserve the original graphic and pictorial appearance of this Amendment shall have the same effect as physical delivery of the paper document bearing original signature.

IN WITNESS WHEREOF, the Parties have caused this Amendment to be executed by their respective duly authorized officers as of the Amendment Effective Date.

 

Q32 BIO INC.
By:  

/s/ Michale Broxson

  (Signature)
Name:   Michael Broxson
Title:   CEO
Date:   July 26, 2022

 

BRISTOL-MYERS SQUIBB COMPANY
By:  

/s/ Robert Plenge

  (Signature)
Name:   Robert Plenge
Title:   SVP
Date:   July 26, 2022

Exhibit 10.47

830 WINTER STREET

WALTHAM, MASSACHUSETTS

LEASE SUMMARY SHEET

 

Execution Date:

3/30/2021

 

Tenant:

Q32 Bio Inc., a Delaware corporation

 

Tenant’s Mailing

One Broadway

Address Prior to

14th Floor

Occupancy:

Cambridge, MA 02142

 

Landlord:

PPF OFF 828-830 WINTER STREET LLC, a Delaware limited liability company

 

Building:

830 Winter Street, Waltham, Massachusetts (the “Building”). The Building consists of three (3) stories, containing approximately 186,835 rentable square feet (the “Building Rentable Area”), including a one-(1)-story garage with eighty-seven (87) spaces (the “830 Garage”). The land on which the Building, the 830 Garage, the 828 Building and the 828 Garage (both as hereinafter defined) are located (the “Land”) is more particularly described in Exhibit 2 attached hereto and made a part hereof.

 

Premises:

Prime Premises: Approximately 14,893 rentable square feet of space on the second (2nd) floor of the Building, as shown on Exhibit 1A.

 

  Basement Premises: The following areas located in the basement of the Building, all as shown on Exhibit 1B attached hereto and (except with respect to the Hazardous Waste and Chemical Storage Premises) dedicated for Tenant’s use in common with any tenant occupying the portion of the third floor of the Building located directly above the Prime Premises (the “Third Floor Tenant”), as more particularly set forth in Section 1.3(e). The portion of the Basement Premises allocated to Tenant comprises approximately 878 rentable square feet of space.

 

  •  

PH System Premises;

 

  •  

Hazardous Waste and Chemical Storage Premises; and

 

  •  

Mechanical Systems Premises, which contains the following systems: (i) RODI; (ii) Compressed Air; and (iii) Central Vacuum.

 

  Generator Premises: As defined and described in Section 1.3(g).

 

1


  The term “Premises” shall mean, collectively, the Prime Premises, Basement Premises, and Generator Premises.

 

Premises Rentable Area:

15,771 rentable square feet. Landlord and Tenant stipulate and agree that the Building Rentable Area and the Premises Rentable Area are correct and shall not be remeasured.

 

Property:

The Building, the Land, and the other improvements located on, and to be constructed on, the Land, including the building known as 828 Winter Street, Waltham, Massachusetts (the “828 Building”) which consists of approximately 145,940 rentable square feet, including a four-(4)-story garage with 523 spaces (the “828 Garage”). The Property is part of the Waltham Woods/Reservoir Woods area (the “Waltham Woods/Reservoir Woods Park”) which, as of the date hereof, consists of the following properties and such other properties as may from time to time participate in the sharing of common exterior maintenance expenses: 840 Winter Street, Waltham Woods (860, 870, 880, and 890 Winter Street), and Reservoir Woods (920, 930, and 940 Winter Street).

 

Parking Areas:

The 830 Garage and the surface parking spaces adjacent to the Building and the 828 Building, and, as specifically set forth in Section 1.3(c) hereof, the 828 Garage.

 

Term Commencement Date:

The date Landlord delivers possession of the Premises to Tenant, which is estimated to be January 1, 2022, subject to acceleration by Landlord as more particularly set forth in Section 1.1(b).

 

Rent Commencement Date:

The Term Commencement Date.

 

Expiration Date:

Ten (10) years after the Term Commencement Date, except that if the Term Commencement Date occurs on a day other than the first day of a calendar month, then the Expiration Date shall be the last day of the calendar month in which the tenth (10th) anniversary of the Term Commencement Date occurs.

 

Extension Term:

Subject to Section 1.2 below, one (1) extension term of five (5) years.

 

2


Permitted Uses:

Prime Premises. Subject to Legal Requirements, general office, research, development and laboratory use, and other ancillary uses related to the foregoing.

 

  PH System Premises: Subject to Legal Requirements, installation and maintenance of equipment for Tenant’s PH waste water treatment system for the Prime Premises, in accordance with applicable Environmental Laws, and other ancillary uses related to the foregoing.

 

  Hazardous Waste and Chemical Storage Premises: Subject to Legal Requirements, storage of Hazardous Materials which are permitted to be introduced by Tenant to the Premises in accordance with the provisions of the Lease and applicable Environmental Laws, and other ancillary uses related to the foregoing.

 

  Mechanical Systems Premises: Subject to Legal Requirements, the placement of Tenant’s mechanical equipment or storage.

 

Base Rent:

   RENT YEAR1                    ANNUAL BASE
RENT
                   MONTHLY
PAYMENT
                 
   Rent Year 1       $969,916.50       $80,826.38   
   Rent Year 2       $999,014.00       $83,251.17   
   Rent Year 3       $1,028,984.41       $85,748.70   
   Rent Year 4       $1,059,853.95       $88,321.16   
   Rent Year 5       $1,091,649.57       $90,970.80   
   Rent Year 6       $1,124,399.05       $93,699.92   
   Rent Year 7       $1,158,131.02       $96,510.92   
   Rent Year 8       $1,192,874.95       $99,406.25   
   Rent Year 9       $1,228,661.20       $102,388.43   
   Rent Year 10       $1,265,521.04       $105,460.09   

 

Operating Costs and Taxes:

See Sections 5.2 and 5.3

 

Tenant’s Share:

8.44% (i.e., a fraction, the numerator of which is the Premises Rentable Area and the denominator of which is the Building Rentable Area).

 

1 

For the purposes of this Lease, the first “Rent Year” shall be defined as the period commencing as of the Term Commencement Date and ending on the date immediately preceding the first (1st) anniversary of the Term Commencement Date; except that if the Term Commencement Date occurs on a day other than the first day of a calendar month, the first Rent Year shall expire as the last day of the calendar month in which the first (1st) anniversary of the Term Commencement Date occurs. Thereafter, “Rent Year” shall be defined as any subsequent twelve (12) month period during the Term of this Lease.

 

3


  Notwithstanding the foregoing, with respect to Cafeteria Costs, as defined in Section 1.3(d), Tenant’s Share shall be defined as a fraction, the numerator of which is the number of employees of Tenant located in the Building and the denominator of which is the number of employees of all tenants at the Property (including Tenant) that have the right to use the Cafeterias.

 

Security Deposit/ Letter of Credit:

$646,611.00, subject to Article 7.

EXHIBITS:

 

EXHIBIT 1A   

LEASE PLAN - PRIME PREMISES

EXHIBIT 1B   

LEASE PLAN - BASEMENT PREMISES

EXHIBIT 1C   

LEASE PLAN - LOCATION OF LOADING DOCKS, RECEIVING AREAS AND FREIGHT ELEVATORS

EXHIBIT 1D   

[INTENTIONALLY OMITTED]

EXHIBIT 1E   

LEASE PLAN - GENERATOR PREMISES

EXHIBIT 2   

LEGAL DESCRIPTION - LAND

EXHIBIT 3   

[INTENTIONALLY OMITTED]

EXHIBIT 4   

TENANT’S WORK

EXHIBIT 5   

[INTENTIONALLY OMITTED]

EXHIBIT 6   

FORM OF LETTER OF CREDIT

EXHIBIT 7   

LANDLORD’S SERVICES

EXHIBIT 8   

TENANT’S HAZARDOUS MATERIALS

EXHIBIT 8-1   

CONTROL AREAS

EXHIBIT 9   

RULES AND REGULATIONS

EXHIBIT 9-1   

BUILDING RULES AND REGULATIONS

EXHIBIT 9-2   

CONSTRUCTION RULES AND REGULATIONS

EXHIBIT 10   

TENANT WORK INSURANCE SCHEDULE

EXHIBIT 11   

PROPOSED PARKING AND TRAFFIC DEMAND MANAGEMENT PLAN

EXHIBIT 11-1   

840 WINTER PARKING OVERFLOW PLAN

 

4


TABLE OF CONTENTS

 

1.

  LEASE GRANT; TERM; APPURTENANT RIGHTS; EXCLUSIONS      1  
  1.1   Lease Grant      1  
  1.2   Extension Term      1  
  1.3   Appurtenant Rights      3  
  1.4   Tenant’s Access      6  
  1.5   No recording // Notice of Lease      7  
  1.6   Exclusions      7  
  1.7   Acid Neutralization Tank      7  

2.

  RIGHTS RESERVED TO LANDLORD      8  
  2.1   Additions and Alterations      8  
  2.2   Additions to the Property      8  
  2.3   Name and Address of Building      8  
  2.4   Landlord’s Access      9  
  2.5   Pipes, Ducts and Conduits      10  
  2.6   Minimize Interference      10  

3.

  CONDITION OF PREMISES      10  
  3.1   Condition of Premises      10  

4.

  USE OF PREMISES      11  
  4.1   Permitted Uses      11  
  4.2   Prohibited Uses      11  
  4.3   Intentionally Omitted      12  
  4.4   MWRA Permit      12  
  4.5   Parking and Traffic Demand Management Plan      12  

5.

  RENT; ADDITIONAL RENT      12  
  5.1   Base Rent      12  
  5.2   Operating Costs      13  
  5.3   Taxes      17  
  5.4   Late Payments      18  
  5.5   No Offset; Independent Covenants; Waiver      19  
  5.6   Survival      20  

6.

  INTENTIONALLY OMITTED      20  

7.

  LETTER OF CREDIT      20  
  7.1   Amount      20  
  7.2   Application of Proceeds of Letter of Credit      20  
  7.3   Transfer of Letter of Credit      21  
  7.4   Cash Proceeds of Letter of Credit      21  
  7.5   Return of Security Deposit or Letter of Credit      21  
  7.6   Reduction in Letter of Credit      21  

8.

  INTENTIONALLY OMITTED      22  

 

i


9.

  UTILITIES, LANDLORD’S SERVICES      22  
  9.1   Electricity      22  
  9.2   Water      22  
  9.3   Gas      22  
  9.4   Other Utilities      23  
  9.5   Interruption or Curtailment of Utilities      23  
  9.6   Landlord’s Services      23  
  9.7   Conservation Requirements      23  

10.

  MAINTENANCE AND REPAIRS      24  
  10.1   Maintenance and Repairs by Tenant      24  
  10.2   Maintenance and Repairs by Landlord      24  
  10.3   Accidents to Sanitary and Other Systems      25  
  10.4   Floor Load—Heavy Equipment      25  
  10.5   Premises Cleaning      25  
  10.6   Pest Control      25  
  10.7   Service Interruptions      26  

11.

  ALTERATIONS AND IMPROVEMENTS BY TENANT      27  
  11.1   Landlord’s Consent Required      27  
  11.2   After-Hours      28  
  11.3   Harmonious Relations      28  
  11.4   Liens      28  
  11.5   General Requirements      28  

12.

  SIGNAGE      29  
  12.1   Restrictions      29  
  12.2   Monument Signage      30  
  12.3   Building Directory/Premises Entrance Signage      30  

13.

  ASSIGNMENT, MORTGAGING AND SUBLETTING      30  
  13.1   Landlord’s Consent Required      30  
  13.2   Landlord’s Recapture Right      31  
  13.3   Standard of Consent to Transfer      31  
  13.4   Listing Confers no Rights      32  
  13.5   Profits In Connection with Transfers      32  
  13.6   Prohibited Transfers      32  
  13.7   Exceptions to Requirement for Consent      32  

14.

  INSURANCE; INDEMNIFICATION; EXCULPATION      33  
  14.1   Tenant’s Insurance      33  
  14.2   Indemnification      35  
  14.3   Property of Tenant      36  
  14.4   Limitation of Landlord’s Liability for Damage or Injury      36  
  14.5   Waiver of Subrogation; Mutual Release      36  
  14.6   Tenant’s Acts—Effect on Insurance      36  
  14.7   Landlord’s Insurance      37  

 

ii


15.

  CASUALTY; TAKING      37  
  15.1   Damage      37  
  15.2   Termination Rights      38  
  15.3   Rent Abatement      39  
  15.4   Taking for Temporary Use      40  
  15.5   Disposition of Awards      40  

16.

  ESTOPPEL CERTIFICATE      40  

17.

  HAZARDOUS MATERIALS      40  
  17.1   Prohibition      40  
  17.2   Environmental Laws      41  
  17.3   Hazardous Material Defined      41  
  17.4   Chemical Safety Program      41  
  17.5   Testing      42  
  17.6   Indemnity; Remediation      42  
  17.7   Disclosures      44  
  17.8   Removal      44  
  17.9   Landlord Obligations with respect to Hazardous Materials.      44  

18.

  RULES AND REGULATIONS      45  
  18.1   Rules and Regulations      45  
  18.2   Energy Conservation      45  
  18.3   Recycling      45  

19.

  LAWS AND PERMITS      45  
  19.1   Legal Requirements      45  

20.

  DEFAULT      46  
  20.1   Events of Default      46  
  20.2   Remedies      48  
  20.3   Damages - Termination.      48  
  20.4   Landlord’s Self-Help; Fees and Expenses      49  
  20.5   Waiver of Redemption, Statutory Notice and Grace Periods      50  
  20.6   Landlord’s Remedies Not Exclusive      50  
  20.7   No Waiver      50  
  20.8   Restrictions on Tenant’s Rights      50  
  20.9   Landlord Default      50  

21.

  SURRENDER; ABANDONED PROPERTY; HOLD-OVER      51  
  21.1   Surrender      51  
  21.2   Abandoned Property      52  
  21.3   Holdover      52  
  21.4   Warranties      53  

22.

  MORTGAGEE RIGHTS      53  
  22.1   Subordination      53  

 

iii


  22.2   Notices      53  
  22.3   Mortgagee Consent      54  
  22.4   Mortgagee Liability      54  

23.

  QUIET ENJOYMENT      54  

24.

  NOTICES      54  

25.

  CONDOMINIUM CONVERSION      55  

26.

  MISCELLANEOUS      56  
  26.1   Separability      56  
  26.2   Captions      56  
  26.3   Broker      56  
  26.4   Entire Agreement      56  
  26.5   Governing Law      56  
  26.6   Representation of Authority      56  
  26.7   Expenses Incurred by Landlord Upon Tenant Requests      57  
  26.8   Survival      57  
  26.9   Limitation of Liability      57  
  26.10   Binding Effect      58  
  26.11   Landlord Obligations upon Transfer      58  
  26.12   No Grant of Interest      58  
  26.13   Financial Information      58  
  26.14   OFAC Certificate and Indemnity      58  
  26.15   Confidentiality      59  
  26.16   Force Majeure      59  

 

iv


THIS INDENTURE OF LEASE (this “Lease”) is hereby made and entered into on the Execution Date by and between Landlord and Tenant.

Each reference in this Lease to any of the terms and titles contained in any Exhibit attached to this Lease shall be deemed and construed to incorporate the data stated under that term or title in such Exhibit. All capitalized terms not otherwise defined herein shall have the meanings ascribed to them as set forth in the Lease Summary Sheet which is attached hereto and incorporated herein by reference.

 

  1.

LEASE GRANT; TERM; APPURTENANT RIGHTS; EXCLUSIONS

 

  1.1

Lease Grant.

(a)    Landlord hereby leases to Tenant, and Tenant hereby leases from Landlord, the Premises upon and subject to terms and conditions of this Lease, for a term. of years commencing on the Term Commencement Date and, unless earlier terminated or extended pursuant to the terms hereof, ending on the Expiration Date (the “Initial Term”; the Initial Term and any duly exercised Extension Terms are hereinafter collectively referred to as the “Term”).

(b)    Acceleration of Term Commencement Date. Subject to Section 3.1, below, Landlord and Tenant acknowledge and agree that Landlord shall have the right to accelerate the Term Commencement Date, which is estimated to be January 1, 2022, to any date occurring from and after July 1, 2021, upon not less than sixty (60) days’ prior written notice to Tenant of such accelerated date. Upon Tenant’s request, Landlord shall provide regular updates to Tenant (which updates may be provided by email or by phone) on the status of negotiations with the existing tenant of the Premises for such existing tenant to surrender possession of the Premises to Landlord prior to the scheduled expiration date of such tenant’s lease.

 

  1.2

Extension Term.

(a)    Provided that the following conditions, which may be waived by Landlord in its sole discretion, are satisfied (i) Tenant, an Affiliated Entity (hereinafter defined) and/or a Successor (hereinafter defined) is/are then occupying seventy-five percent (75%) of the Premises; and (ii) no uncured Event of Default exists (1) as of the date of the Extension Notice (hereinafter defined), and (2) at the commencement of the Extension Term (hereinafter defined), Tenant shall have the option to extend the Term for one (1) additional term of five (5) years (the “Extension Term”), commencing as of the expiration of the Initial Term. Tenant must exercise such option to extend, if at all, by giving Landlord written notice (the “Extension Notice”) on or before the date that is no earlier than eighteen (18) months and not later than twelve (12) months prior to the expiration of the current term of this Lease, time being of the essence. Upon the timely giving of such notice, the Term shall be deemed extended upon all of the terms and conditions of this Lease, except that Base Rent during the Extension Term shall be calculated in accordance with this Section 1.2, Landlord shall have no obligation to construct or renovate the Premises and Tenant shall have no further right to extend the Term. If Tenant fails to give timely notice, as aforesaid, Tenant shall have no further right to extend the Term. Notwithstanding the fact that Tenant’s proper and timely exercise of such option to extend the Term shall be self-executing, the parties shall promptly execute a lease amendment reflecting such Extension Term after Tenant exercises such option. The execution of such lease amendment shall not be deemed to waive any of the conditions to Tenant’s exercise of its rights under this Section 1.2.

 

1


(b)    The Base Rent during the Extension Term (the “Extension Term Base Rent”) shall be determined in accordance with the process described hereafter. Extension Term Base Rent shall be the fair market rental value of the Premises then demised to Tenant as of the commencement of the Extension Term as determined in accordance with the process described below, for renewals of combination laboratory and office space in the Winter Street area of Waltham of equivalent quality, size, utility and location, with the length of the Extension Term, the credit standing of Tenant, any economic concessions (including, without limitation, tenant improvement allowances and free rent) then being provided by landlords to tenants, and all other relevant factors to be taken into account. Within thirty (30) days after receipt of the Extension Notice, Landlord shall deliver to Tenant written notice of its determination of the Extension Term Base Rent for the Extension Term. Tenant shall, within thirty (30) days after receipt of such notice, notify Landlord in writing whether Tenant accepts or rejects Landlord’s determination of the Extension Term Base Rent (“Tenant’s Response Notice”). If Tenant fails timely to deliver Tenant’s Response Notice, Landlord’s determination of the Extension Term Base Rent shall be binding on Tenant.

(c)    If and only if Tenant’s Response Notice is timely delivered to Landlord and indicates both that Tenant rejects Landlord’s determination of the Extension Term Base Rent and desires to submit the matter to arbitration, then the Extension Term Base Rent shall be determined in accordance with the procedure set forth in this Section 1.2(c). In such event, within ten (10) days after receipt by Landlord of Tenant’s Response Notice indicating Tenant’s desire to submit the determination of the Extension Term Base Rent to arbitration, Tenant and Landlord shall each notify the other, in writing, of their respective selections of an appraiser (respectively, “Landlord’s Appraiser” and “Tenant’s Appraiser”). Landlord’s Appraiser and Tenant’s Appraiser shall then jointly select a third appraiser (the “Third Appraiser”) within ten (10) days of their appointment. All of the appraisers selected shall be individuals with at least five (5) consecutive years’ commercial appraisal experience for office and laboratory space in the area in which the Premises are located, shall be members of the Appraisal Institute (M.A.I.), and, in the case of the Third Appraiser, shall not have acted in any capacity for either Landlord or Tenant within five (5) years of his or her selection. The three appraisers shall determine the Extension Term Base Rent in accordance with the requirements and criteria set forth in Section 1.2(b) above, employing the method commonly known as Baseball Arbitration, whereby Landlord’s Appraiser and Tenant’s Appraiser each sets forth its determination of the Extension Term Base Rent as defined above, and the Third Appraiser must select one or the other (it being understood that the Third Appraiser shall be expressly prohibited from selecting a compromise figure). Landlord’s Appraiser and Tenant’s Appraiser shall deliver their determinations of the Extension Term Base Rent to the Third Appraiser within five (5) days of the appointment of the Third Appraiser and the Third Appraiser shall render his or her decision within ten (10) days after receipt of both of the other two determinations of the Extension Term Base Rent. The Third Appraiser’s decision shall be binding on both Landlord and Tenant. Each party shall bear the cost of its own appraiser and the cost of the Third Appraiser shall be paid by the party whose determination is not selected.

 

2


1.3    Appurtenant Rights.

(a)    Common Areas. Subject to the terms of this Lease and the Rules and Regulations (hereinafter defined), Tenant shall have, as appurtenant to the Premises, rights to use in common with others entitled thereto, the following areas (such areas are hereinafter referred to as the “Common Areas”): (i) the common loading docks, hallways, lobby, and elevator of the Building serving the Premises, (ii) the common lavatories located on the floor(s) on which the Premises are located, (iii) common walkways and driveways necessary for access to the Building, (iv) the Parking Areas and (v) other areas and facilities designated by Landlord from time to time for the common use of tenants of the Building and others entitled thereto; and no other appurtenant rights or easements. The current location of the loading docks, receiving areas and freight elevators serving the Building are shown on Exhibit 1C attached hereto.

(b)    Parking. During the Term, Landlord shall, subject to the terms hereof, make available up to thirty-eight (38) unreserved parking spaces in the aggregate for Tenant’s use, at no additional charge, six (6) of which will be located within the 830 Garage, with the remaining thirty-two (32) located within the 828 Garage and the surface parking areas serving the Building. The parking spaces in the parking areas allocated to Tenant, as modified pursuant to this Lease or as otherwise permitted by Landlord, are hereinafter referred to as the “Parking Spaces.” Tenant shall have no right to hypothecate or encumber the Parking Spaces, and shall not sublet, assign, or otherwise transfer the Parking Spaces other than to employees of Tenant occupying the Premises or to a Successor (hereinafter defined), an Affiliated Entity (hereinafter defined) or a transferee pursuant to an approved Transfer under Section 13 of this Lease. Subject to Landlord’s right to reserve parking for other tenants of the Building, said Parking Spaces will be on an unassigned, non-reserved basis, and shall be subject to such reasonable rules and regulations as may be in effect for the use of the parking areas from time to time. Reserved and handicap parking spaces must be honored. Notwithstanding anything to the contrary contained herein, Landlord shall have the right, upon at least three (3) months’ written notice to Tenant, to temporarily (i.e., for a period of time not to exceed six (6) months) relocate all or any portion of the Parking Spaces in to other portions of the Property and/or parking areas owned, controlled or leased by Landlord in the vicinity of the Property within a quarter-mile radius of the Land, in which event Landlord shall provide shuttle service between any such relocated Parking Spaces and the Building. In addition, Landlord may, at its election, implement valet and tandem parking in order to accommodate the parking needs of the Property from time to time. Tenant hereby acknowledges that Landlord has granted to an adjacent property owner the right to park up to 120 vehicles in the parking facilities serving the Building, for overflow parking, in the location shown on the plan attached hereto as Exhibit 11-1, on a daily basis between the hours of 7 p.m. to 7 a.m. (the “Off Business Hours Parking Hours”). The foregoing acknowledgement shall not affect Tenant’s rights under this Section 1.3(c) with respect to any time period other than during the Off Business Hours Parking Hours.

(c)    Cafeterias. Subject to the provisions of this Section 1.3(d), Tenant, its employees, contractors, and visitors shall have the right to use in common with others entitled thereto: (i) the existing cafeteria currently being operated in the Building (“830 Cafeteria”), and (ii) the cafeteria in the 828 Building (the “828 Cafeteria”)(the 828 Cafeteria and the 830 Cafeteria are referred to collectively herein as the “Cafeterias” so long as Tenant has the right to use them). Subject to the provisions of Section 5.2, any amounts paid by Landlord to such third party operator(s) on account of its operation of the Cafeteria(s) in excess of the net revenues derived from the operation of the Cafeteria(s) shall be included in Operating Costs, as shall all of

 

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Landlord’s costs of cleaning, maintaining, and repairing the Cafeteria(s) (collectively referred to herein as (“Cafeteria Costs”). If for any reason Landlord or the owner of the 828 Building decides to cease operating a Cafeteria, then within thirty (30) days after delivery of written notice from Landlord to Tenant of Landlord’s decision, then Tenant shall no longer have the right to use such Cafeteria and that portion of the Building shall be removed from the calculation of Common Areas and Tenant’s Proportionate Shares shall be adjusted accordingly.

(d)    Shower and Changing Rooms. During the Term, Tenant and its employees shall have the right to use in common with others entitled thereto the shower and changing rooms located in the 828 Building (the “Shower and Changing Rooms”). Landlord shall, at its expense, install and maintain card readers at appropriate access points to the Shower and Changing Rooms and issue identification cards to authorized users. Subject to Section 5.2 of this Lease, any amounts paid by Landlord on account of its operation of the Shower and Changing Rooms (including, without limitation, Landlord’s costs of cleaning, maintaining, and repairing the Shower and Changing Rooms) shall be included in Operating Costs.

(e)    Basement Premises. During the Term, Tenant shall have the exclusive right to use that portion of the basement of the Building comprised of the Hazardous Waste and Chemical Storage Premises, and the right, in common with the Third Floor Tenant, to use the PH System Premises and the Mechanical Systems Premises, all as substantially shown on Exhibit 1B (the Hazardous Waste and Chemical Storage Premises, PH System Premises, and Mechanical Systems Premises collectively being hereinafter referred to as the “Basement Premises”), for the Permitted Uses set forth hereinabove. Tenant hereby acknowledges and agrees that Tenant’s allocation of 878 rentable square feet of the Basement Premises is solely for the purposes of determining Rent and Operating Costs, and said allocation shall not affect Tenant’s and the Third Floor Tenant’s respective rights to use the aforementioned portions of the Basement Premises in common with each other.

(i)    Tenant shall accept the Basement Premises “as is” in the condition in which the Basement Premises is in as of the Term Commencement Date, without any obligation on the part of Landlord to prepare or construct the Basement Premises for Tenant’s use or occupancy. Without limiting the foregoing, Landlord makes no warranties or representations to Tenant as to the suitability of the Basement Premises for the Permitted Uses. Tenant shall have no right to make any changes, alterations, additions, decorations or other improvements to the Basement Premises without Landlord’s prior written consent.

(ii)    From and after the Term Commencement Date, Landlord shall maintain the Basement Premises and systems contained therein in good condition and repair, and shall obtain, and maintain all governmental permits and approvals necessary for the operation and maintenance of the Basement Premises. Landlord shall be responsible for all costs, charges and expenses incurred from time to time in connection with or arising out of the operation, use, maintenance, repair, refurbishment or replacement of the Basement Premises and any of the systems contained therein (the “Basement Premises Costs”), and such Basement Premises Costs shall be included in Operating Costs, except, subject to Section 14.5, to the extent such costs are caused by the negligence or willful misconduct of Tenant. Notwithstanding anything in this Lease to the contrary, with respect to the Basement Premises Costs, Landlord and Tenant hereby acknowledge and agree that

 

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Tenant’s proportionate share shall equal 36.98% (based on the ratio of Tenant’s allocation of the Basement Premises (878 rentable square feet) to the total rentable square footage of the Basement Premises (2,374 rentable square feet)).

(iii)    Tenant shall comply with all reasonable rules and regulations promulgated by Landlord in the use and operation of the Basement Premises.

(f)    Generator Premises. Reference is made to the fact that there is an existing generator (“Generator”) located as shown on Exhibit 1E (the “Generator Premises”). Tenant shall have the right to use the Generator, in common with the Third Floor Tenant, through the Term of the Lease subject to the terms and conditions of this Section 1.3(f) and the provisions of the Lease. In addition, Tenant shall comply with all reasonable construction rules and regulations promulgated by Landlord in the maintenance and operation of the Generator. All electricity generated by the Generator and consumed by Tenant may only be consumed by Tenant in the Premises. Tenant’s use of the Generator hereunder is subject to a capacity limitation of 336,500 watts, which represents approximately 36.98% of the overall capacity of the Generator.

(i)    Tenant shall have no obligation to pay Base Rent or Taxes in respect of the Generator.

(ii)    From and after the Term Commencement Date, Landlord shall maintain the Generator in good condition and repair, and shall obtain, and maintain all governmental permits and approvals necessary for the operation and maintenance of the Generator and the Generator Premises. Landlord shall be responsible for all costs, charges and expenses incurred from time to time in connection with or arising out of the operation, use, maintenance, repair, refurbishment or replacement of the Generator Premises and any of the systems contained therein (the “Generator Premises Costs”), and such Generator Premises Costs shall be included in Operating Costs, except, subject to Section 14.5, to the extent such costs are caused by the negligence or willful misconduct of Tenant. Notwithstanding anything in this Lease to the contrary, with respect to the Generator Premises Costs, Landlord and Tenant hereby acknowledge and agree that Tenant’s proportionate share shall equal 36.98%.

(iii)    Tenant, at Tenant’s sole cost, and subject to the provisions of this Lease (including, without limitation, Section 11 hereof) shall have the right to install wiring in locations designated by Landlord in order to connect the Generator to Tenant’s electrical system serving the Prime Premises. Tenant shall have no right to make any other changes, alterations, additions, decorations or other improvements (collectively “Installations”) to the Generator.

(iv)    Tenant shall have no right to remove the Generator or the Installations, if any.

(v)    Tenant shall be responsible for the cost of repairing any damage to the Building and/or the Generator caused by the installation by Tenant of any Installations.

(vi)    Tenant shall have no right to sublet the Generator or to assign its interest hereunder, other than to an Affiliated Entity or Successor as defined in Section 13.7 of this Lease, a Recapture Exempt Sublease as defined in Section 13.2 of this Lease, or a transferee pursuant to an approved Transfer under Section 13 of this Lease.

 

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(vii)    To the maximum extent permitted by law, the Generator and all Installations in the Generator Premises shall be at the sole risk of Tenant, and Landlord shall have no liability to Tenant in the event that the Generator or any Installations are damaged for any reason, except to the extent caused by the negligent acts, negligent omissions or willful misconduct of Landlord or any of the Landlord Parties.

(viii)    Subject to Section 10.1 of the Lease and to Landlord’s obligation to maintain the Generator in good condition and repair as set forth in Section 1.3(f)(ii), above: (x) Tenant shall take the Generator “as-is” in the condition in which the Generator is in as of the Term Commencement Date, without any obligation on the part of Landlord to prepare or construct the Generator for Tenant’s use or occupancy, and (y) without limiting the foregoing, Landlord makes no warranties or representations to Tenant as to the suitability of the Generator for Tenant’s intended use thereof.

(ix)    In addition to and without limiting Tenant’s obligations under the Lease, Tenant shall comply with all applicable environmental and fire prevention laws, ordinances and regulations in Tenant’s use of the Generator.

(x)    Subject to Section 10.1, Tenant shall, at Tenant’s sole cost and expense, repair and maintain Tenant’s connections to the Generator and Installations.

(xi)    In addition to and without limiting the insurance provisions of the Lease, Tenant shall procure, keep in force and pay for Commercial General Liability Insurance in respect of the Generator of not less than One Million ($1,000,000.00) Dollars in the event of personal injury to any number of persons or damage to property, arising out of any one occurrence and such insurance shall name Landlord as an additional insured party. Tenant shall have the right to maintain the aforesaid insurance under umbrella coverages.

(xii)    In addition to and without limiting the indemnification provisions set forth in the Lease, Tenant shall, to the maximum extent permitted by law and subject to Section 14.5, indemnify, defend, and hold Landlord harmless from any and all claims, losses, demands, actions, or causes of actions suffered by any person, firm, corporation, or other entity arising from Tenant’s use of the Generator, except to the extent caused by the negligent acts, negligent omissions or willful misconduct of Landlord or any of the Landlord Parties.

1.4    Tenant’s Access.

(a)    From and after the Term Commencement Date and until the end of the Term, Tenant shall have access to the Premises twenty-four (24) hours a day, seven (7) days a week, subject to Landlord’s reasonable Building security requirements, causes beyond Landlord’s reasonable control, Legal Requirements, the Rules and Regulations, the terms of this Lease, Force Majeure (hereinafter defined) and matters of record.

 

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1.5    No recording // Notice of Lease. Neither party shall record this Lease. Tenant shall not record a memorandum of this Lease and/or a notice of this Lease. Notwithstanding the foregoing, if the Initial Term plus any Extension Term(s) exceeds in the aggregate seven (7) years, Landlord agrees to join in the execution, in recordable form, of a statutory notice of lease and/or written declaration in which shall be stated the Term Commencement Date, the Rent Commencement Date, the length of the Extension Term(s) and the Expiration Date, which notice of lease may be recorded by Tenant with the Middlesex South Registry of Deeds and/or filed with the Middlesex South Registry District of the Land Court, as appropriate (alternatively and collectively, the “Registry”) at Tenant’s sole cost and expense. If a notice of lease was previously recorded with the Registry, upon the expiration or earlier termination of this Lease, Landlord shall deliver to Tenant a notice of termination of lease and Tenant shall promptly execute, acknowledge, and deliver the same (together with any other instrument(s) that may be necessary in order to record and/or file same with the Registry) to Landlord for Landlord’s execution and recordation with the Registry, which obligation shall survive the expiration or earlier termination of the Lease.

1.6    Exclusions. The following are expressly excluded from the Premises and reserved to Landlord: all the perimeter walls of the Premises (except the inner surfaces thereof), the Common Areas, and any space in or adjacent to the Premises used for shafts, stacks, pipes, conduits, wires and appurtenant fixtures, fan rooms, ducts, electric or other utilities, sinks or other Building facilities, and the use of all of the foregoing, except as expressly permitted pursuant to Section 1.3(a) above.

1.7    Acid Neutralization Tank. The provisions of this Section 1.7 are subject to Section 10.1 below:

(a)    There currently exists an acid neutralization tank (the “Acid Neutralization Tank”) that is located in the PH System Premises. Tenant acknowledges and agrees that Tenant is leasing the Acid Neutralization Tank in its “AS IS,” “WHERE IS” condition and with all faults on the Execution Date, without representations or warranties, express or implied, in fact or by law, of any kind, or recourse to Landlord. Tenant shall have the right, in common with the Third Floor Tenant, throughout the Term of the Lease, as the same may be extended, to use the Acid Neutralization Tank in accordance with Legal Requirements. Landlord shall obtain, and maintain all governmental permits and approvals necessary for the operation and maintenance of the Acid Neutralization Tank; provided that Tenant shall be responsible during the Term for compliance with such permits and approvals with respect to Tenant’s use of the Acid Neutralization Tank, as more particularly set forth in Section 4.4, below. Tenant shall reimburse Landlord for Tenant’s proportionate share of all costs, charges and expenses incurred from time to time in connection with or arising out of the operation, use, maintenance, repair or refurbishment of the Acid Neutralization Tank by Landlord, including all clean-up costs relating to the Acid Neutralization Tank (collectively, “Tank Costs”), except, subject to Section 14.5, to the extent such costs are caused by the negligence or willful misconduct of any of the Landlord Parties (as hereinafter defined). Notwithstanding anything in this Lease to the contrary, with respect to the Tank Costs, Landlord and Tenant hereby acknowledge and agree that Tenant’s proportionate share shall equal 36.98%.

(b)    Landlord shall be responsible for the operation, cleanliness, and maintenance of the Acid Neutralization Tank and the appurtenances, all of which shall remain the

 

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personal property of Landlord, and shall be left in place by Tenant at the expiration or earlier termination of the Lease. Subject to Landlord’s obligation to maintain the Acid Neutralization Tank, Tenant shall take the Acid Neutralization Tank “as is” in the condition in which the Acid Neutralization Tank Premises is in as of the Term Commencement Date, without any obligation on the part of Landlord to prepare or construct the PH System Premises for Tenant’s use or occupancy. Without limiting the foregoing, Landlord makes no warranties or representations to Tenant as to the suitability of the Acid Neutralization and the PH System Premises for the operation of the Acid Neutralization Tank. Tenant shall have no right to make any changes, alterations, additions, decorations or other improvements to the PH System Premises without Landlord’s prior written consent which shall not be unreasonably withheld, conditioned or delayed.

2.    RIGHTS RESERVED TO LANDLORD

2.1    Additions and Alterations. Landlord reserves the right, at any time and from time to time, to make such changes, alterations, additions, improvements, repairs or replacements in or to the Property (including the Premises but, with respect to the Premises, only for purposes of repairs, maintenance, replacements and the exercise of any other rights expressly reserved to Landlord herein) and the fixtures and equipment therein, as well as in or to the street entrances and/or the Common Areas, as it may deem necessary or desirable, provided, however, that there be no material obstruction of permanent access to, or material interference with the use and enjoyment of, the Premises by Tenant. Subject to the foregoing, Landlord expressly reserves the right to temporarily close all, or any portion, of the Common Areas for the purpose of making repairs or changes thereto.

2.2    Additions to the Property.

(a)    Landlord may at any time or from time to time (i) construct additional improvements and related site improvements (collectively, “Future Development”) in all or any part of the Property, (ii) change the location or arrangement of any improvement outside the Building in or on the Property or all or any part of the Common Areas, or add or deduct any land to or from the Property; provided that there shall be no material increase in Tenant’s obligations or material interference with Tenant’s rights under this Lease in connection with the exercise of the foregoing reserved rights.

(b)    In case any excavation shall be made for building or improvements or for any other purpose upon the land adjacent to or near the Premises, Tenant will afford without charge to Landlord, or the person or persons, firms or corporations causing or making such excavation, license to enter upon the Premises for the purpose of doing such work as Landlord or such person or persons, firms or corporation shall deem to be necessary to preserve the walls or structures of the Building from injury, and to protect the Building by proper securing of foundations.

2.3    Name and Address of Building. Landlord reserves the right at any time and from time to time to change the name or address of the Building and/or the Property, provided Landlord gives Tenant at least three (3) months’ prior written notice thereof.

 

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2.4    Landlord’s Access.

(a)    Subject to the terms hereof, Tenant shall (a) upon reasonable advance notice but in any event not less than forty-eight (48) hours), which may be via email at mvigliotta@q32bio.com or such other address as may be provided in writing by Tenant to Landlord (except that no notice shall be required in emergency situations), permit Landlord and any holder of a Mortgage (hereinafter defined) (each such holder, a “Mortgagee”), and the agents, representatives, employees and contractors of each of them, to have reasonable access to the Premises at all reasonable hours for the purposes of inspection, making repairs, replacements or improvements in or to the Premises or the Building or equipment therein (including, without limitation, sanitary, electrical, heating, air conditioning or other systems), complying with all applicable laws, ordinances, rules, regulations, statutes, by-laws, court decisions and orders and requirements of all public authorities (collectively, “Legal Requirements”), or exercising any right reserved to Landlord under this Lease (including without limitation the right to take upon or through, or to keep and store within the Premises all necessary materials, tools and equipment); (b) permit Landlord and its agents and employees, at reasonable times, upon reasonable advance notice, to show the Premises during normal business hours (i.e. Monday – Friday 8 a.m.. – 6 p.m., Saturday 8 a.m. – 1 p.m., excluding holidays) to any prospective Mortgagee or purchaser of the Building and/or the Property or of the interest of Landlord therein, and, during the last twelve (12) months of the Term or at any time after the occurrence of an Event of Default, prospective tenants; and (c) upon reasonable prior written notice from Landlord, permit Landlord and its agents, at Landlord’s sole cost and expense, to perform environmental audits, environmental site investigations and environmental site assessments (“Site Assessments”) in, on, under and at the Premises and the Land, it being understood that Landlord shall repair any damage arising as a result of the Site Assessments, and such Site Assessments may include both above and below the ground testing and such other tests as may be necessary or appropriate to conduct the Site Assessments. In addition, to the extent that it is necessary to enter the Premises in order to access any area that serves any portion of the Building outside the Premises, then Tenant shall, upon as much advance notice as is practical under the circumstances, and in any event at least twenty-four (24) hours’ prior written notice (except that no notice shall be required in emergency situations), permit contractors engaged by other occupants of the Building to pass through the Premises in order to access such areas but only if accompanied by a representative of Landlord. Notwithstanding anything to the contrary contained herein, Tenant shall be entitled to have a representative present for any access by Landlord or any of the Landlord Parties in exercising its rights under this Section 2.4.

(b)    Secure Area within the Premises. Notwithstanding the foregoing, Tenant, at its own expense may, as hereinafter set forth, designate one or more areas of the Premises to be “Secure Areas” (i.e., portions of the Premises to which Landlord shall not have a right of entry or access for any reason whatsoever (except as otherwise provided below). Tenant may, from time to time, exercise its right to create Secure Areas by delivering to Landlord, for Landlord’s written approval, a plan showing the location of any such Secure Areas. Landlord agrees that it will not unreasonably withhold, condition or delay such consent. If Landlord must gain access to a Secure Areas in a non-emergency situation, Landlord shall contact Tenant, and Landlord and Tenant shall arrange a mutually agreed upon time for Landlord to have such access. Landlord shall be accompanied by an employee of Tenant or a party designated by Tenant (the “Escort”). Tenant shall make an Escort available to Landlord during business hours. At all times, Landlord shall

 

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comply with all reasonable security measures of the Tenant pertaining to the Secure Areas. If an emergency representing an imminent risk of injury to persons or material property damage in the Building or the Premises, including, without limitation, a suspected fire or flood, requires Landlord to gain access to the Secure Areas, Landlord may enter the Secure Areas without an Escort. If practicable under the circumstances, Landlord shall immediately notify (which may be oral notification) and request that Tenant make an Escort available to Landlord if time permits, and if Tenant shall not make an Escort available to accompany Landlord, then Tenant hereby authorizes Landlord to enter the Secure Areas forcibly or with a master key, and to enter without an Escort. In any such event, except (subject to Section 14.5 of this Lease) to the extent resulting from Landlord’s negligence or willful misconduct, Landlord shall have no liability whatsoever to Tenant, and Tenant shall pay all reasonable expenses incurred by Landlord in repairing or reconstructing any entrance, corridor, door or other portions of the Premises damaged as a result of a forcible entry by Landlord. Landlord shall have no obligation to provide either janitorial service or cleaning in the Secure Areas unless Tenant shall make arrangements to have an Escort in the Secure Areas at the time such service or cleaning is provided to the remainder of the Premises.

2.5    Pipes, Ducts and Conduits. Tenant shall permit Landlord to erect, use, maintain and relocate pipes, ducts and conduits in and through the Premises, provided the same do not reduce the rentable square footage of the Premises other than by a de minimus amount, or adversely affect the appearance of the Premises. In exercising its right in this Section 2.5, Landlord shall make commercially reasonable efforts to locate any pipes, ducts, and conduits behind walls and above ceilings so as to minimize interference with the Premises.

2.6    Minimize Interference. Except in the event of an emergency, Landlord shall use commercially reasonable efforts to minimize any interference with Tenant’s business operations and use and occupancy of the Premises in connection with the exercise any of the foregoing rights under this Article 2.

3.    CONDITION OF PREMISES.

3.1    Condition of Premises. Landlord shall deliver the Premises to Tenant in vacant, broom-clean condition, and shall repair any visible damage (excluding ordinary wear and tear) caused to the Premises resulting from the existing tenant’s move-out, and Tenant acknowledges and agrees that Tenant is leasing the Premises in their “AS IS,” “WHERE IS” condition and with all faults on the Term Commencement Date, without representations or warranties, express or implied, in fact or by law, of any kind, and without recourse to Landlord. As of the Term Commencement Date all base Building systems serving the Premises shall be in good condition and repair, and the Premises shall be in substantially the same configuration and condition as on the Execution Date, reasonable wear and tear excepted. On or before the Term Commencement Date, Landlord shall provide Tenant with evidence that the Premises (excluding the Acid Neutralization Tank, which will not be decommissioned and will be maintained by Landlord in accordance with Section 1.7, above) have been decommissioned in accordance with applicable Legal Requirements. Without limiting the generality of the foregoing, Landlord shall provide Tenant with a copy of the decommissioning report on or before the Term Commencement Date.

 

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4.    USE OF PREMISES

4.1    Permitted Uses. During the Term, Tenant shall use the Premises only for the Permitted Uses and for no other purposes. Service and utility areas (whether or not a part of the Premises) shall be used only for the particular purpose for which they are designed. Tenant shall keep the Premises equipped with appropriate safety appliances to the extent required by applicable laws or insurance requirements. Landlord shall cooperate with Tenant, in such manner as Tenant may reasonably request, in assisting Tenant to obtain any governmental permits or approvals necessary to enable Tenant to use the Premises for any of the Permitted Uses, provided that Landlord shall not be obligated to incur any out-of-pocket costs or expenses or incur any liability in connection with any such request.

4.2    Prohibited Uses.

(a)    Notwithstanding any other provision of this Lease, Tenant shall not use the Premises or the Building, or any part thereof, or suffer or permit the use or occupancy of the Premises or the Building or any part thereof by any of the Tenant Parties (i) in a manner which would violate any of the covenants, agreements, terms, provisions and conditions of this Lease or otherwise applicable to or binding upon the Premises; (ii) for any unlawful purposes or in any unlawful manner; (iii) which, in the reasonable judgment of Landlord (taking into account the use of the Building as a combination laboratory, research and development and office building and the Permitted Uses) shall (a) impair, interfere with or otherwise diminish the quality of any of the Building services or the proper and economic heating, cleaning, ventilating, air conditioning or other servicing of the Building or Premises, or the use or occupancy of any of the Common Areas; (b) occasion impairment, interference or injury in any material respect (and Tenant shall not install or use any electrical or other equipment of any kind, which, in the reasonable judgment of Landlord, will cause any such impairment, interference, or injury), or cause any injury or damage to any occupants of the Premises or other tenants or occupants of the Building or their property; or (c) cause harmful air emissions, laboratory odors or noises or any unusual or other objectionable odors, noises or emissions to emanate from the Premises; (iv) in a manner which is inconsistent with the operation and/or maintenance of the Building as a first-class combination office, research, development and laboratory facility; or (v) in a manner which shall increase such insurance rates on the Building or on property located therein over that applicable when Tenant first took occupancy of the Premises hereunder. Notwithstanding the foregoing, Landlord agrees that Tenant’s use of the Premises for the Permitted Use (as opposed to the particular manner of Tenant’s use of the Premises) shall not, in and of itself, be deemed to breach the provisions of this Section 4.2.

(b)    With respect to the use and occupancy of the Premises and the Common Areas, Tenant will not: (i) place or maintain any signage (except as set forth in Section 12.2 below), trash, refuse or other articles in any vestibule or entry of the Premises, on the footwalks or corridors adjacent thereto or elsewhere on the exterior of the Premises, nor obstruct any driveway, corridor, footwalk, parking area, mall or any other Common Areas; (ii) permit undue accumulations of or burn garbage, trash, rubbish or other refuse within or without the Premises; (iii) permit the parking of vehicles so as to interfere with (x) the ability of others, entitled thereto, to park in the common parking areas, or (y) the use of any driveway, corridor, footwalk, parking area, or other Common Areas; (iv) receive or ship articles of any kind outside of those areas

 

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reasonably designated by Landlord; (v) conduct or permit to be conducted any auction, going out of business sale, bankruptcy sale (unless directed by court order), or other similar type sale in or connected with the Premises; (vi) use the name of Landlord, or any of Landlord’s affiliates in any publicity, promotion, trailer, press release, advertising, printed, or display materials without Landlord’s prior written consent; or (vii) except in connection with Alterations (hereinafter defined) approved by Landlord, cause or permit any hole to be drilled or made in any part of the Building.

4.3    Intentionally Omitted.

4.4    MWRA Permit. Tenant shall establish and maintain with respect to its use of wastewater facilities exclusively serving the Premises, an MWRA waste water discharge program administered by a licensed, qualified individual (which individual may be (i) a third party contractor/consultant approved by Landlord, which approval shall not be unreasonably withheld, or (ii) an employee of Tenant or Tenant’s affiliate) in accordance with the requirements of the Massachusetts Water Resources Authority (“MWRA”) and any other applicable governmental authority. Tenant shall be solely responsible for all costs incurred in connection with such MWRA waste water discharge, and Tenant shall provide Landlord with such documentation as Landlord may reasonably require evidencing Tenant’s compliance with the requirements of (a) the MWRA and any other applicable governmental authority with respect to such chemical safety program and (b) this Section. With respect to Tenant’s use of any acid neutralization tank exclusively serving the Premises in the Building, Tenant shall obtain and maintain during the Term: (i) any permit required by the MWRA (“MWRA Permit”) and (ii) a wastewater treatment operator license from the Commonwealth of Massachusetts. Tenant shall not introduce anything into any acid neutralization tank serving the Premises, (x) in violation of the terms of an MWRA Permit, (y) in violation of Legal Requirements or (z) that would interfere with the proper functioning of any such acid neutralization tank.

4.5    Parking and Traffic Demand Management Plan. The Property is subject to a Parking and Traffic Demand Management Plan with the City of Waltham, a copy of which is attached hereto as Exhibit 11 (the “ PTDM”). Tenant agrees, at its sole expense, to comply with the requirements of the PTDM, only insofar as they apply to the Premises and/or Tenant’s use and occupancy thereof. In the event that the PTDM is ever modified, supplemented, amended or replaced (“PTDM Modifications”), Tenant agrees, at its sole expense, to comply with the requirements of the PTDM Modifications, only insofar as they apply to the Premises and/or Tenant’s use and occupancy thereof.

5.    RENT; ADDITIONAL RENT

5.1    Base Rent. During the Term, Tenant shall pay to Landlord Base Rent in equal monthly installments, in advance and without demand on the first day of each month for and with respect to such month. Unless otherwise expressly provided herein, the payment of Base Rent, additional rent and other charges reserved and covenanted to be paid under this Lease with respect to the Premises (collectively, “Rent”) shall commence on the Rent Commencement Date, and shall be prorated for any partial months. Rent shall be payable to Landlord or, if Landlord shall so direct in writing, to Landlord’s agent or nominee, in lawful money of the United States which shall be legal tender for payment of all debts and dues, public and private, at the time of payment.

 

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5.2    Operating Costs.

(a)    “Operating Costs” shall mean all costs incurred and expenditures of whatever nature made by Landlord in the operation, management, repair, replacement, maintenance and insurance (including, without limitation, environmental liability insurance and property insurance on Landlord-supplied leasehold improvements for tenants, but not property insurance on tenants’ equipment) of the Property or allocated to the Property, including without limitation all costs of labor (wages, salaries, fringe benefits, etc.) up to and including the Property manager, however denominated, any costs for utilities supplied to exterior areas and the Common Areas, and any costs for repair and replacements, cleaning and maintenance of exterior areas and the Common Areas (including, without limitation, the Building’s share of Common Expenses under the Condominium Documents and costs of maintaining and operating the exterior common areas and facilities of the Waltham Woods/Reservoir Woods Park allocable to the Building), related equipment, facilities and appurtenances and HVAC equipment, security services, a management fee paid to Landlord’s property manager in an amount not to exceed four percent (4%) of gross revenues of the Building, the costs, including, without limitation, a commercially reasonable rental factor, of Landlord’s management office for the Property, which management office may be located outside the Property and which may serve other properties in addition to the Property (in which event such costs shall be equitably allocated among the properties served by such office), the cost of operating any amenities in the Property available to all tenants of the Property and any subsidy provided by Landlord for or with respect to any such amenity. For costs and expenditures made by Landlord in connection with the operation, management, repair, replacement, maintenance and insurance of the Building as a whole, Landlord shall make a reasonable allocation thereof between the retail and non-retail portions of the Building, if applicable. Operating Costs shall not include Excluded Costs (hereinafter defined).

(b)    Capital Expenditures. Permitted Capital Expenditures (as hereinafter defined) shall only be included in Operating Costs for each fiscal year during the Term of this Lease to the extent of the Annual Charge-Off, as hereinafter defined, for such fiscal year with respect to such capital expenditure. Operating Costs shall not include any Annual Charge-Off with respect to Excluded Costs, as hereinafter defined. For the purposes hereof:

(i)    “Annual Charge-Off” means the annual amount of principal and interest payments which would be required to repay a loan in equal monthly installments over the Useful Life, as defined below, of the capital item in question on a direct reduction basis at an annual interest rate equal to the Capital Interest Rate, as defined below, where the initial principal balance is the cost of the capital item in question.

(ii)    “Useful Life” shall be reasonably determined by Landlord in accordance with generally accepted accounting principles and commercially reasonable practices in effect at the time of acquisition of the capital item.

(iii)    “Capital Interest Rate” shall be defined as an annual rate of either one percentage point over the AA bond rate (Standard & Poor’s corporate composite or, if unavailable, its equivalent) as reported in the financial press at the time the capital expenditure is made or, if the capital item is acquired through third-party financing, then the actual (including fluctuating) rate paid by Landlord in financing the acquisition of such capital item.

 

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(c)    “Excluded Costs” shall be defined as (i) any fixed or percentage ground rent payable to any ground lessor, or any mortgage charges (including interest, principal, points and fees)and any debt service costs (provided however, that the provisions of this clause (i) shall not be deemed to exclude mortgage charges and debt service costs incurred with respect to Permitted Capital Expenditures, as hereinafter defined, from Operating Costs); (ii) brokerage commissions, marketing costs, concessions and leasehold improvement costs incurred in connection with entering into leases for any rentable space at the Building or Campus including, without limitation, finders’ fees, attorneys’ fees and expenses, entertainment costs and travel expenses; (iii) salaries and bonuses and benefits of officers, executives of Landlord and administrative employees above the grade of Property manager; (iv) the cost of work done by Landlord for a particular tenant or any special work or service performed for any tenant (including Tenant) billable to such tenant or any costs in connection with services or benefits that are provided to or for the particular benefit of other tenants but not offered to Tenant; (v) the cost of items which, by generally accepted accounting principles, would be capitalized on the books of Landlord or are otherwise not properly chargeable against income, except to the extent such capital item is (A) required by any Legal Requirements following the Execution Date of this Lease, or (B) reasonably projected to reduce Operating Costs (collectively, “Permitted Capital Expenditures”); (vi) any contributions made by Landlord to any tenant of the Property in connection with the build-out of its premises; (vii) franchise or income taxes imposed on Landlord; (viii) costs paid directly by individual tenants to suppliers, including tenant electricity, telephone and other utility costs; (ix) increases in premiums for insurance when such increase is caused by the use of the Building by Landlord or any other tenant of the Building; (x) depreciation of the Building; (xi) costs relating to maintaining Landlord’s existence as a corporation, partnership or other entity; (xii) the cost of any items for which Landlord is reimbursed by insurance, condemnation awards, refund, rebate or otherwise, and any expenses for repairs or maintenance covered by warranties, guaranties and service contracts; and (xiii) costs incurred in connection with any disputes between Landlord and its employees, between Landlord and Building management, or between Landlord and other tenants or occupants; (xiv) Taxes; (xv) the cost of any repairs or restoration required because of fire or other casualty, provided, however, that Operating Costs may include costs of repairs which are not covered because the cost of such repairs is within a commercially reasonable deductible carried under Landlord’s casualty insurance policy (Tenant hereby agreeing that, as of the Execution Date, $25,000.00 is a commercially reasonable deductible), (xvi) management and administrative fees, other than as provided in Section 5.2(a) above; (xvii) the cost of remediating Hazardous Materials from the Building or the Campus other than Included Hazardous Materials, as hereinafter defined; “Included Hazardous Materials” shall be defined as all Hazardous Materials, other than: (A) any material or substance located in the Building or the Property on the Execution Date which, as of the Execution Date, is not considered under then existing Legal Requirements, to be Hazardous Material, but which is subsequently determined to be a Hazardous Material by reason of a Legal Requirement which first becomes effective after the Execution Date of this Lease, and (B) any material or substance that is introduced to the Building or the Property after the Execution Date which, when introduced to the Building or the Property, is not then (i.e., at the time of introduction to the Building or the Property) considered, as a matter of any Legal Requirement, to be a Hazardous Material, but which is subsequently determined to be a Hazardous Material by reason of Legal Requirements which first

 

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becomes effective after the date of introduction of such material or substance to the Building or Property; (xviii) any cost covered by a warranty that Landlord is required to obtain pursuant to this Lease in connection with the Building or the Land; (xix) any amounts paid to a person, firm, corporation or other entity under common ownership and control with Landlord that is in excess of a commercially reasonable amount paid on a market rate basis (other than management fees); (xx) the cost of acquiring sculptures, paintings, and other objects of art; (xxi) depreciation of the Building or Campus or any part thereof (provided however, that the provisions of this clause (xxi) shall not be deemed to exclude depreciation incurred with respect to Permitted Capital Expenditures from Operating Costs); (xxii) any compensation paid to personnel in retail concessions operated by Landlord and any subsidies or concessions to third parties operating retail concessions at the Building or the Campus, provided that the provisions of this clause (xxii) shall not be deemed to exclude from Operating Costs such compensation, subsidies or concessions incurred by Landlord with respect the Cafeteria and the Fitness Center; (xxiii) replacement or contingency reserves; (xxiv) Landlord’s general overhead, provided however, that the provisions of this clause (xxiv) shall not be deemed to exclude an equitable allocation of Management Office Costs, as set forth in Section 5.2(a) above; and (xxv) any costs incurred with respect to the retail portions of the Building, provided that the provisions of this clause (xxv) shall not be deemed to exclude from Operating Costs incurred by Landlord with respect the Cafeterias and the Shower and Changing Rooms. Notwithstanding anything to the contrary contained herein, the properly passed through cost of any Permitted Capital Expenditures shall be amortized over the useful life of such capital item.

(d)    Payment of Operating Costs. Commencing as of the Term Commencement Date and continuing thereafter throughout the remainder of the Term of the Lease, Tenant shall pay to Landlord, as additional rent, Tenant’s Share of Operating Costs. Landlord may make a good faith estimate of Tenant’s Share of Operating Costs for any fiscal year or part thereof during the Term, and Tenant shall pay to Landlord, on the Term Commencement Date and on the first (1st) day of each calendar month thereafter, an amount equal to Tenant’s Share of Operating Costs for such fiscal year and/or part thereof divided by the number of months therein. Landlord may estimate and re-estimate Tenant’s Share of Operating Costs and deliver a copy of the estimate or re-estimate to Tenant. Thereafter, the monthly installments of Tenant’s Share of Operating Costs shall be appropriately adjusted in accordance with the estimations so that, by the end of the fiscal year in question, Tenant shall have paid all of Tenant’s Share of Operating Costs as estimated by Landlord. Any amounts paid based on such an estimate shall be subject to adjustment as herein provided when actual Operating Costs are available for each fiscal year. As of the Execution Date, the Property’s fiscal year is January 1 – December 31.

(e)    Annual Reconciliation. Landlord shall, within one hundred twenty (120) days after the end of each fiscal year, deliver to Tenant a reasonably detailed statement of the actual amount of Operating Costs for such fiscal year (“Year End Statement”). Failure of Landlord to provide the Year End Statement within the time prescribed shall not relieve Tenant from its obligations hereunder; provided, however, that Landlord shall be obligated to bill any Operating Costs on or before the date (the “Outside Billing Date”) which is two (2) years after the end of the fiscal year in which the expenditure is made. If the total of such monthly remittances on account of any fiscal year is greater than Tenant’s Share of Operating Costs actually incurred for such fiscal year, then, provided no uncured Event of Default has occurred, Tenant may credit the difference against the next installment of additional rent on account of Operating Costs due

 

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hereunder, except that if such difference is determined after the end of the Term, Landlord shall refund such difference to Tenant within thirty (30) days after such determination to the extent that such difference exceeds any amounts then due from Tenant to Landlord. If the total of such remittances is less than Tenant’s Share of Operating Costs actually incurred for such fiscal year, Tenant shall pay the difference to Landlord, as additional rent hereunder, within thirty (30) days of Tenant’s receipt of an invoice therefor. Landlord’s estimate of Operating Costs for the next fiscal year shall be based upon the Operating Costs actually incurred for the prior fiscal year as reflected in the Year-End Statement plus a reasonable adjustment based upon estimated increases in Operating Costs. The provisions of this Section 5.2(e) shall survive the expiration or earlier termination of this Lease.

(f)    Part Years. If the Term Commencement Date or the Expiration Date occurs in the middle of a fiscal year, Tenant shall be liable for only that portion of the Operating Costs with respect to such fiscal year within the Term.

(g)    Gross-Up. If, during any fiscal year, less than 95% of the Building is occupied by tenants or if Landlord was not supplying all tenants with the services being supplied to Tenant hereunder, actual Operating Costs incurred shall be reasonably extrapolated by Landlord on an item-by-item basis to the reasonable Operating Costs that would have been incurred if the Building was 95% occupied and such services were being supplied to all tenants, and such extrapolated Operating Costs shall, for all purposes hereof, be deemed to be the Operating Costs for such fiscal year. This “gross up” treatment shall be applied only with respect to variable Operating Costs arising from services provided to Common Areas or to space in the Building being occupied by tenants (which services are not provided to vacant space or may be provided only to some tenants) in order to allocate equitably such variable Operating Costs to the tenants receiving the benefits thereof.

(h)    Audit Right. Provided there is no Event of Default nor any event which, with the passage of time and/or the giving of notice would constitute an Event of Default, Tenant may, upon at least thirty (30) days’ prior written notice, inspect or audit Landlord’s records relating to Operating Costs for any periods of time within the previous fiscal year before the audit or inspection. However, no audit or inspection shall extend to periods of time before the Rent Commencement Date. If Tenant fails to object to the calculation of Tenant’s Share of Operating Costs on the Year-End Statement within ninety (90) days after such statement has been delivered to Tenant and/or fails to complete any such audit or inspection within one hundred twenty (120) days after receipt of the Year End Statement, then Tenant shall be deemed to have waived its right to object to the calculation of Tenant’s Share of Operating Costs for the year in question and the calculation thereof as set forth on such statement shall be final. Tenant’s audit or inspection shall be conducted only at Landlord’s offices or the offices of Landlord’s property manager during business hours reasonably designated by Landlord. Tenant shall pay the cost of such audit or inspection. Tenant may not conduct an inspection or have an audit performed more than once during any fiscal year. If such inspection or audit reveals that an error was made in the calculation of Tenant’s Share of Operating Costs previously charged to Tenant, then, provided there is no Event of Default nor an event which, with the passage of time and/or the giving of notice would constitute an Event of Default, Tenant may credit the difference against the next installment of additional rent on account of Operating Costs due hereunder, except that if such difference is determined after the end of the Term, Landlord shall refund such difference to Tenant within thirty

 

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(30) days after such determination to the extent that such difference exceeds any amounts then due from Tenant to Landlord. If such inspection or audit reveals an underpayment by Tenant, then Tenant shall pay to Landlord, as additional rent hereunder, any underpayment of any such costs, as the case may be, within thirty (30) days after receipt of an invoice therefor. Tenant shall maintain the results of any such audit or inspection confidential and shall not be permitted to use any third party to perform such audit or inspection, other than an independent firm of certified public accountants (A) reasonably acceptable to Landlord, (B) which is not compensated on a contingency fee basis or in any other manner which is dependent upon the results of such audit or inspection, and (C) which executes Landlord’s standard confidentiality agreement whereby it shall agree to maintain the results of such audit or inspection confidential. The provisions of this Section 5.2(h) shall survive the expiration or earlier termination of this Lease.

5.3    Taxes.

(a)    “Taxes” shall mean the real estate taxes and other taxes, levies and assessments imposed upon the Building and the Land, and upon any personal property of Landlord used in the operation thereof, or on Landlord’s interest therein or such personal property; charges, fees and assessments for transit, housing, police, fire or other services or purported benefits to the Building and the Land (including without limitation any community preservation assessments); service or user payments in lieu of taxes; and any and all other taxes, levies, betterments, assessments and charges arising from the ownership, leasing, operation, use or occupancy of the Building and the Land or based upon rentals derived therefrom, which are or shall be imposed by federal, state, county, municipal or other governmental authorities. From and after substantial completion of any occupiable improvements constructed as part of a Future Development, if such improvements are not separately assessed, Landlord shall reasonably allocate Taxes between the Building and such improvements and the land area associated with the same. Taxes shall not include any inheritance, estate, succession, gift, franchise, rental, income or profit tax, capital stock tax, capital levy or excise, or any income taxes arising out of or related to the ownership and operation of the Building and the Land, provided, however, that any of the same and any other tax, excise, fee, levy, charge or assessment, however described, that may in the future be levied or assessed as a substitute for or an addition to, in whole or in part, any tax, levy or assessment which would otherwise constitute Taxes, whether or not now customary or in the contemplation of the parties on the Execution Date of this Lease, shall constitute Taxes, but only to the extent calculated as if the Building and the Land were the only real estate owned by Landlord. “Taxes” shall also include reasonable expenses (including without limitation legal and consultant fees) of tax abatement or other proceedings contesting assessments or levies.

(b)    “Tax Period” shall be any fiscal/tax period in respect of which Taxes are due and payable to the appropriate governmental taxing authority (i.e., as mandated by the governmental taxing authority), any portion of which period occurs during the Term of this Lease.

(c)    Payment of Taxes. Commencing as of the Term Commencement Date and continuing thereafter throughout the remainder of the Term of the Lease, Tenant shall pay to Landlord, as additional rent, Tenant’s Share of Taxes. Landlord may make a good faith estimate of the Taxes to be due by Tenant for any Tax Period or part thereof during the Term, and Tenant shall pay to Landlord, on the Term Commencement Date and on the first (1st) day of each calendar month thereafter, an amount equal to Tenant’s Share of Taxes for such Tax Period or part thereof

 

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divided by the number of months therein. Landlord may estimate and re-estimate Tenant’s Share of Taxes and deliver a copy of the estimate or re-estimate to Tenant. Thereafter, the monthly installments of Tenant’s Share of Taxes shall be appropriately adjusted in accordance with the estimations so that, by the end of the Tax Period in question, Tenant shall have paid all of Tenant’s Share of Taxes as estimated by Landlord. Any amounts paid based on such an estimate shall be subject to adjustment as herein provided when actual Taxes are available for each Tax Period. If the total of such monthly remittances is greater than Tenant’s Share of Taxes actually due for such Tax Period, then, provided no Event of Default has occurred nor any event which, with the passage of time and/or the giving of notice would constitute an Event of Default, Tenant may credit the difference against the next installment of additional rent on account of Taxes due hereunder, except that if such difference is determined after the end of the Term, Landlord shall refund such difference to Tenant within thirty (30) days after such determination to the extent that such difference exceeds any amounts then due from Tenant to Landlord. If the total of such remittances is less than Tenant’s Share of Taxes actually due for such Tax Period, Tenant shall pay the difference to Landlord, as additional rent hereunder, within thirty (30) days of Tenant’s receipt of an invoice therefor. Landlord’s estimate for the next Tax Period shall be based upon actual Taxes for the prior Tax Period plus a reasonable adjustment based upon estimated increases in Taxes. The provisions of this Section 5.3(c) shall survive the expiration or earlier termination of this Lease.

(d)    Effect of Abatements. Appropriate credit against Taxes shall be given for any refund obtained by reason of a reduction in any Taxes by the assessors or the administrative, judicial or other governmental agency responsible therefor after deduction of Landlord’s expenditures for reasonable legal fees and for other reasonable expenses incurred in obtaining the Tax refund.

(e)    Part Years. If the Term Commencement Date or the Expiration Date occurs in the middle of a Tax Period, Tenant shall be liable for only that portion of the Taxes, as the case may be, with respect to such Tax Period within the Term.

5.4    Late Payments.

(a)    Any payment of Rent due hereunder not paid when due shall bear interest for each month or fraction thereof from the due date until paid in full at the annual rate of eighteen percent (18%), or at any applicable lesser maximum legally permissible rate for debts of this nature (the “Default Rate”).

(b)    Additionally, if Tenant fails to make any payment within five (5) days after the due date therefor, Landlord may charge Tenant a fee, which shall constitute liquidated damages, equal to three percent (3%) of any such late payment, provided, however, Landlord shall waive the late fee once in any twelve (12) month period in the event Tenant shall pay such late payments within five (5) days following Landlord’s written notice to Tenant of the occurrence of such late payment.

(c)    For each Tenant payment check to Landlord that is returned by a bank for any reason, Tenant shall pay a returned check charge equal to the amount as shall be customarily charged by Landlord’s bank at the time.

 

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(d)    Money paid by Tenant to Landlord shall be applied to Tenant’s account in the following order: first, to any unpaid additional rent, including without limitation late charges, returned check charges, legal fees and/or court costs chargeable to Tenant hereunder; and then to unpaid Base Rent.

(e)    The parties agree that the late charge referenced in Section 5.4(b) represents a fair and reasonable estimate of the costs that Landlord will incur by reason of any late payment by Tenant, and the payment of late charges and interest are distinct and separate in that the payment of interest is to compensate Landlord for the use of Landlord’s money by Tenant, while the payment of late charges is to compensate Landlord for Landlord’s processing, administrative and other costs incurred by Landlord as a result of Tenant’s delinquent payments. Acceptance of a late charge or interest shall not constitute a waiver of Tenant’s default with respect to the overdue amount or prevent Landlord from exercising any of the other rights and remedies available to Landlord under this Lease or at law or in equity now or hereafter in effect.

(f)    If Tenant during any six (6) month period shall be more than five (5) days delinquent in the payment of any installment of Rent on three (3) or more occasions, then, notwithstanding anything herein to the contrary, Landlord may, by written notice to Tenant, elect to require Tenant to pay all Base Rent and additional rent on account of Operating Costs and Taxes quarterly in advance. Such right shall be in addition to and not in lieu of any other right or remedy available to Landlord hereunder or at law on account of Tenant’s default hereunder.

5.5    No Offset; Independent Covenants; Waiver. Rent shall be paid without notice or demand, and without setoff, counterclaim, defense, abatement, suspension, deferment, reduction or deduction, except as expressly provided herein. TENANT WAIVES ALL RIGHTS (I) TO ANY ABATEMENT, SUSPENSION, DEFERMENT, REDUCTION OR DEDUCTION OF OR FROM RENT, AND (II) TO QUIT, TERMINATE OR SURRENDER THIS LEASE OR THE PREMISES OR ANY PART THEREOF, EXCEPT AS EXPRESSLY PROVIDED HEREIN. TENANT HEREBY ACKNOWLEDGES AND AGREES THAT THE OBLIGATIONS OF TENANT HEREUNDER SHALL BE SEPARATE AND INDEPENDENT COVENANTS AND AGREEMENTS, THAT RENT SHALL CONTINUE TO BE PAYABLE IN ALL EVENTS AND THAT THE OBLIGATIONS OF TENANT HEREUNDER SHALL CONTINUE UNAFFECTED, UNLESS THE REQUIREMENT TO PAY OR PERFORM THE SAME SHALL HAVE BEEN TERMINATED PURSUANT TO AN EXPRESS PROVISION OF THIS LEASE. LANDLORD AND TENANT EACH ACKNOWLEDGES AND AGREES THAT THE INDEPENDENT NATURE OF THE OBLIGATIONS OF TENANT HEREUNDER REPRESENTS FAIR, REASONABLE, AND ACCEPTED COMMERCIAL PRACTICE WITH RESPECT TO THE TYPE OF PROPERTY SUBJECT TO THIS LEASE, AND THAT THIS AGREEMENT IS THE PRODUCT OF FREE AND INFORMED NEGOTIATION DURING WHICH BOTH LANDLORD AND TENANT WERE REPRESENTED BY COUNSEL SKILLED IN NEGOTIATING AND DRAFTING COMMERCIAL LEASES IN MASSACHUSETTS, AND THAT THE ACKNOWLEDGEMENTS AND AGREEMENTS CONTAINED HEREIN ARE MADE WITH FULL KNOWLEDGE OF THE HOLDING IN WESSON V. LEONE ENTERPRISES, INC., 437 MASS. 708 (2002). SUCH ACKNOWLEDGEMENTS, AGREEMENTS AND WAIVERS BY TENANT ARE A MATERIAL INDUCEMENT TO LANDLORD ENTERING INTO THIS LEASE.

 

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5.6    Survival. Any obligations under this Article 5 which shall not have been paid at the expiration or earlier termination of the Term shall survive such expiration or earlier termination and shall be paid when and as the amount of same shall be determined and be due.

6.    INTENTIONALLY OMITTED.

7.    LETTER OF CREDIT.

7.1    Amount. Contemporaneously with the execution of this Lease, Tenant shall deliver to Landlord an irrevocable letter of credit (the “Letter of Credit”) that shall (a) be in the initial amount of Six Hundred Forty-Six Thousand Six Hundred Eleven Dollars ($646,611.00); (b) be issued on the form attached hereto as Exhibit 6, or other form reasonably approved by Landlord; (c) name Landlord as its beneficiary; (d) be drawn on an FDIC insured financial institution reasonably satisfactory to Landlord (the “Approved Issuer”) that both (x) has an office in the greater Boston metropolitan area that will accept presentation of, and pay against, the Letter of Credit and (y) satisfies both the Minimum Rating Agency Threshold and the Minimum Capital Threshold (as those terms are defined below). The “Minimum Rating Agency Threshold” shall mean that the issuing bank has outstanding unsecured, uninsured and unguaranteed senior long-term indebtedness that is then rated (without regard to qualification of such rating by symbols such as “+” or “-” or numerical notation) “Baa” or better by Moody’s Investors Service, Inc. and/or “BBB” or better by Standard & Poor’s Rating Services, or a comparable rating by a comparable national rating agency designated by Landlord in its discretion. The “Minimum Capital Threshold” shall mean that the issuing bank has combined capital, surplus and undivided profits of not less than $10,000,000,000. Notwithstanding the foregoing, Landlord hereby agrees that, as of the Execution Date, Silicon Valley Bank is an Approved Issuer. The Letter of Credit (and any renewals or replacements thereof) shall be for a term of not less than one (1) year. If the issuer of the Letter of Credit gives notice of its election not to renew such Letter of Credit for any additional period, Tenant shall be required to deliver a substitute Letter of Credit satisfying the conditions hereof at least thirty (30) days prior to the expiration of the term of such Letter of Credit. If the issuer of the Letter of Credit fails to satisfy either or both of the Minimum Rating Agency Threshold or the Minimum Capital Threshold, Tenant shall be required to deliver a substitute letter of credit from another issuer reasonably satisfactory to the Landlord and that satisfies both the Minimum Rating Agency Threshold and the Minimum Capital Threshold not later than ten (10) Business Days after Landlord notifies Tenant of such failure. Tenant agrees that it shall from time to time, as necessary, whether as a result of a draw on the Letter of Credit by Landlord pursuant to the terms hereof or as a result of the expiration of the Letter of Credit then in effect, renew or replace the original and any subsequent Letter of Credit so that a Letter of Credit, in the amount required hereunder, is in effect until a date which is at least sixty (60) days after the Expiration Date. If Tenant fails to furnish such renewal or replacement at least sixty (60) days prior to the stated expiration date of the Letter of Credit then held by Landlord, Landlord may draw upon such Letter of Credit and hold the proceeds thereof (and such proceeds need not be segregated) as a Security Deposit pursuant to the terms of this Article 7. Any renewal or replacement of the original or any subsequent Letter of Credit shall meet the requirements for the original Letter of Credit as set forth above, except that such replacement or renewal shall be issued by an Approved Issuer.

7.2    Application of Proceeds of Letter of Credit. Upon an Event of Default, or if any proceeding shall be instituted by or against Tenant pursuant to any of the provisions of any Act of

 

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Congress or State law relating to bankruptcy, reorganizations, arrangements, compositions or other relief from creditors (and, in the case of any proceeding instituted against it, if Tenant shall fail to have such proceedings dismissed within thirty (30) days) or if Tenant is adjudged bankrupt or insolvent as a result of any such proceeding, Landlord at its sole option may draw down all or a part of the Letter of Credit. The balance of any Letter of Credit cash proceeds shall be held in accordance with Section 7.4 below. Should the entire Letter of Credit, or any portion thereof, be drawn down by Landlord, Tenant shall, upon the written demand of Landlord, deliver a replacement Letter of Credit in the amount drawn, and Tenant’s failure to do so within ten (10) days after receipt of such written demand shall constitute an additional Event of Default hereunder. The application of all or any part of the cash proceeds of the Letter of Credit to any obligation or default of Tenant under this Lease shall not deprive Landlord of any other rights or remedies Landlord may have nor shall such application by Landlord constitute a waiver by Landlord.

7.3    Transfer of Letter of Credit. In the event that Landlord transfers its interest in the Premises, Tenant shall upon notice from and at no cost to Landlord, deliver to Landlord an amendment to the Letter of Credit or a replacement Letter of Credit naming Landlord’s successor as the beneficiary thereof. If Tenant fails to deliver such amendment or replacement within ten (10) days after written notice from Landlord, Landlord shall have the right to draw down the entire amount of the Letter of Credit and hold the proceeds thereof in accordance with Section 7.4 below.

7.4    Cash Proceeds of Letter of Credit. Landlord shall hold the balance of proceeds remaining after a draw on the Letter of Credit (each hereinafter referred to as the “Security Deposit”) as security for Tenant’s performance of all its Lease obligations. After an Event of Default, Landlord may apply the Security Deposit, or any part thereof, to Landlord’s damages without prejudice to any other Landlord remedy. Landlord has no obligation to pay interest on the Security Deposit and may co-mingle the Security Deposit with Landlord’s funds. If Landlord conveys its interest under this Lease, the Security Deposit, or any part not applied previously, may be turned over to the grantee in which case Tenant shall look solely to the grantee for the proper application and return of the Security Deposit.

7.5    Return of Security Deposit or Letter of Credit. Should Tenant comply with all of such terms, covenants and conditions and promptly pay all sums payable by Tenant to Landlord hereunder, the Security Deposit and/or Letter of Credit or the remaining proceeds therefrom, as applicable, shall be returned to Tenant within forty-five (45) days after the end of the Term, less any portion thereof which may have been utilized by Landlord to cure any default or applied to any actual damage suffered by Landlord.

7.6    Reduction in Letter of Credit. Subject to the remaining terms of this Article 7, and provided that (x) there has been no monetary or material non-monetary Event of Default within the twelve (12) months prior to the Reduction Date, and (y) there is no then-current Event of Default under the Lease as of the Reduction Date (the “Reduction Conditions”), Tenant shall have the right to reduce the amount of the Security Deposit and/or Letter of Credit to Five Hundred Twenty-Nine Thousand Eight Hundred Fifty-Nine and 77/100 Dollars ($529,859.77) as of the date on which Tenant has raised Seventy-Five Million Dollars ($75,000,000.00) in equity investments plus non-dilutive capital fundraising, as evidenced by supporting documentation reasonably acceptable to Landlord (the “Reduction Date”). The reduction in the Security Deposit shall be accomplished as follows: Tenant shall request such reduction in a written notice to Landlord, and

 

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if the Reduction Conditions have been met, Landlord shall so notify Tenant, whereupon Tenant shall provide Landlord with a Substitute Letter of Credit in the reduced amount, or an amendment to the Letter of Credit reducing it to the reduced amount and if Tenant provides Landlord with a Substitute Letter of Credit, Landlord shall simultaneously return the existing Letter of Credit to Tenant together with a letter to the issuing bank authorizing its cancellation. The Security Deposit, as it may be reduced in accordance with the foregoing, shall continue to be held by Landlord throughout the Term of the Lease.

8.    INTENTIONALLY OMITTED.

9.    UTILITIES, LANDLORD’S SERVICES

9.1    Electricity. Landlord shall contract with the electric utility company to provide for electric service to the Property, including the Premises, subject to a capacity limitation with respect to the Premises of 172,500 watts. Commencing on the Term Commencement Date, Tenant shall pay Tenant’s pro rata share of all charges for electricity furnished to the Premises and any equipment exclusively serving the Premises, as additional rent, based on Landlord’s reasonable estimate of such electric usage. Notwithstanding the foregoing, Tenant, as part of Tenant’s Work, shall install a separate check meter, after which point Tenant shall pay all charges for electricity as measured by such check meter. Tenant shall, at Tenant’s sole cost and expense, maintain and keep in good order, condition and repair the metering equipment used to measure electricity furnished to the Premises and any equipment exclusively serving the same. Tenant shall pay to Landlord the full amount of any charges invoiced by Landlord (if prior to the installation of such check meter) or attributable to such check meter (from and after the installation of such check meter), based on Landlord’s reading of such check meter, on or before the later to occur of (i) the due date therefor or thirty (30) days following delivery of an invoice for such costs from Landlord. At Tenant’s request, Landlord shall provide Tenant with reasonable back-up documentation regarding the total charges and the method of allocating the charges to Tenant.

9.2    Water. Landlord shall contract with the utility provider for water service to the Property, including the Premises. Except as otherwise provided below, the cost of providing water service to the Premises and all other portions of the Building (including, without limitation, the premises of other tenants or occupants of the Building) shall be included in Operating Costs. Notwithstanding the foregoing, if Landlord determines that Tenant is using water in excess of its proportionate share (by floor area) of the total water usage in the Building, Landlord may elect, at Tenant’s expense, to furnish and install in a location in or near the Premises metering equipment to measure water furnished to the Premises and any equipment exclusively serving the same. In such event, Tenant shall, within thirty (30) days after Landlord’s written demand therefor from time to time, pay to Landlord, as additional rent, the full amount of any water service charges attributable to such meter.

9.3    Gas. Landlord shall contract with the utility provider for gas service to the Property, including the Premises. The cost of gas used to serve base building plumbing, mechanical and electrical systems shall be included in the costs reimbursed by Tenant pursuant to Section 9.6 below. If Tenant requires gas service for the operation of Tenant’s laboratory equipment in the Premises, Tenant shall pay all charges for gas furnished to the Premises and/or any equipment exclusively serving the Premises as additional rent, based, at Landlord’s election,

 

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(1)    on Landlord’s reasonable estimate of such gas usage or (ii) on metering or submetering equipment installed by Landlord at Tenant’s expense. Tenant shall pay the full amount of any such charges on or before the later to occur of (i) the due date therefor or (ii) thirty (30) days following delivery of an invoice for such costs from Landlord.

9.4    Other Utilities. Subject to Landlord’s reasonable rules and regulations governing the same, Tenant shall obtain and pay, as and when due, for all other utilities and services consumed in and/or furnished to the Premises, together with all taxes, penalties, surcharges and maintenance charges pertaining thereto.

9.5    Interruption or Curtailment of Utilities. When necessary by reason of accident or emergency, or for repairs, alterations, replacements or improvements which in the reasonable judgment of Landlord are desirable or necessary to be made, Landlord reserves the right, upon as much prior notice to Tenant as is practicable under the circumstances and no less than twenty-four (24) hours’ notice except in the event of an emergency, to interrupt, curtail, or stop (i) the furnishing of hot and/or cold water, and (ii) the operation of the plumbing and electric systems. Landlord shall exercise reasonable diligence to eliminate the cause of any such interruption, curtailment, stoppage or suspension, but, except as set forth in Section 10.7, there shall be no diminution or abatement of Rent or other compensation due from Landlord to Tenant hereunder, nor shall this Lease be affected or any of Tenant’s obligations hereunder reduced, and Landlord shall have no responsibility or liability for any such interruption, curtailment, stoppage, or suspension of services or systems.

9.6    Landlord’s Services. Subject to reimbursement pursuant to Section 5.2 above, Landlord shall provide the services described in Exhibit 7 attached hereto and made a part hereof (“Landlord’s Services”), at the level of service set forth therein. All costs incurred in connection with the provision of Landlord’s Services shall be included in Operating Costs. Tenant shall pay such costs monthly, together with monthly installments of Base Rent, on an estimated basis in amounts from time to time reasonably determined by Landlord. After the close of each fiscal year, Landlord shall determine the actual amount of such costs for such year and deliver to Tenant a reasonably detailed statement thereof, together with a statement of the amounts paid by Tenant on an estimated basis toward such costs as aforesaid. If such statement indicates that the estimated amounts paid by Tenant are less than Tenant’s allocable share of the actual amount of such costs for such fiscal year, then Tenant shall pay the amount of such shortfall to Landlord within thirty (30) days after delivery of such statement. If such statement indicates that Tenant’s estimated payments for such year exceed the actual amount of such costs for such year, then Landlord shall credit the excess against the next due installment(s) of additional rent payable under this Section 9.6.

9.7    Conservation Requirements.

(a)    Notwithstanding the foregoing, the services and utilities to be provided by Landlord under this Lease, and the obligations and responsibilities of Landlord in connection therewith, shall be subject to such energy, water or other conservation controls, limitations, or requirements (whether mandatory or voluntary) of general applicability to comparable office buildings imposed or issued by applicable governmental agencies or authorities, or public utilities or insurance carriers, including, without limitation, controls, limitations or requirements

 

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concerning the permitted range of temperature settings or imposing limitations or restrictions on the volume of energy consumption. If and to the extent required to comply with such energy, water or other conservation controls, limitations, or requirements (whether mandatory or voluntary) of general applicability to comparable office buildings issued by applicable governmental agencies or authorities, or public utilities or insurance carriers, Landlord shall not be deemed in violation of the terms and conditions of this Lease for the duration of such controls or requirements and the compliance by Landlord with such controls, limitations, or requirements shall not be considered an eviction, actual or constructive, of Tenant from the Premises and shall not entitle Tenant to terminate this Lease or to an abatement or reduction of any rent payable hereunder. Notwithstanding the foregoing, as to any such controls, limitations, or requirements that are voluntary rather than mandatory, the exculpation afforded by the foregoing clauses shall not be applicable unless comparable first-class office buildings in the city in which the Building is located have generally instituted similar controls, limitations, or requirements.

(b)    Landlord shall provide and install bulbs and tubes for Building standard lighting fixtures within the Premises and replacement tubes for such lighting, and the cost of such bulbs and tubes, together with the costs for replacement bulbs and tubes in the premises of other tenants of the Building, shall be included in Operating Costs; provided, however, (x) the cost of replacement of any specialty bulbs or tubes installed by Landlord at Tenant’s request and the costs of ballasts replaced by Landlord in the Premises shall be paid by Tenant as Additional Rent, and (y) the cost of replacement of specialty bulbs or tubes of other tenants or ballasts replaced in other premises shall not be included in Operating Costs. Notwithstanding the foregoing, Landlord may elect to cease generally providing replacement of standard bulbs and tubes for tenants of the Building, in which event Tenant shall pay Landlord for such replacements as it requests as Additional Rent and the cost of replacements for Tenant and other tenants of the Building shall cease to be included in Operating Costs.

10.    MAINTENANCE AND REPAIRS

10.1    Maintenance and Repairs by Tenant. Tenant shall keep neat and clean and free of insects, rodents, vermin and other pests and in good repair, order and condition the Premises, including without limitation the entire interior of the Premises, all electronic, phone and data cabling and related equipment (other than building service equipment) that is installed by or for the exclusive benefit of the Tenant (whether located in the Premises or other portions of the Building), all fixtures, equipment and specialty lighting therein, electrical equipment wiring, doors, non-structural walls, windows and floor coverings, and all laboratory specific systems and equipment that exclusively serve the Premises, including, without limitation, equipment critical to laboratory operations, reasonable wear and tear and damage by Casualty excepted.

10.2    Maintenance and Repairs by Landlord. Except as otherwise provided in Article 15, and subject to Tenant’s obligations in Section 10.1 above, Landlord shall maintain and keep in good working order: (i) the Building foundation, the Building roof, Building structure, exterior windows and related assemblies, structural floor slabs and columns of the Building, and (ii) the base Building systems, including, without limitation, all common mechanical, electrical and HVAC systems serving the Building in good repair, order and condition. In addition, Landlord shall operate and maintain the Common Areas in substantially the same manner as comparable combination office and laboratory facilities in the vicinity of the Premises. All costs incurred by Landlord under this Section 10.2 shall be included in Operating Costs as provided in Section 5.2.

 

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10.3    Accidents to Sanitary and Other Systems. Tenant shall give to Landlord prompt notice of any fire or accident in the Premises or in the Building and of any damage to, or defective condition in, any part or appurtenance of the Building including, without limitation, sanitary, electrical, ventilation, heating and air conditioning or other systems located in, or passing through, the Premises. Except as otherwise provided in Article 15, and subject to Tenant’s obligations in Section 10.1 above, such damage or defective condition shall be remedied by Landlord with reasonable diligence, but, subject to Section 14.5 below, if such damage or defective condition was caused by any of the Tenant Parties, the cost to remedy the same shall be paid by Tenant.

10.4    Floor Load—Heavy Equipment. Tenant shall not place a load upon any floor of the Premises exceeding the floor load per square foot of area which such floor was designed to carry and which is allowed by Legal Requirements. The floor load capacity of the Premises is 100 pounds per square foot. Landlord reserves the right to prescribe the weight and position of all safes, heavy machinery, heavy equipment, freight, bulky matter or fixtures (collectively, “Heavy Equipment”), in a commercially reasonable manner, which shall be placed so as to distribute the weight. Heavy Equipment shall be placed and maintained by Tenant at Tenant’s expense in settings sufficient in Landlord’s reasonable judgment to absorb and prevent vibration, noise and annoyance. Tenant shall not move any Heavy Equipment into or out of the Building without giving Landlord prior written notice thereof and observing all of Landlord’s Rules and Regulations with respect to the same. If such Heavy Equipment requires special handling, Tenant agrees to employ only persons holding a Master Rigger’s License to do said work, and that all work in connection therewith shall comply with Legal Requirements. Any such moving shall be at the sole risk and hazard of Tenant and Tenant will defend, indemnify and save Landlord and Landlord’s agents (including without limitation its property manager), contractors and employees (collectively with Landlord, the “Landlord Parties”) harmless from and against any and all claims, damages, losses, penalties, costs, expenses and fees (including without limitation reasonable legal fees) (collectively, “Claims”) resulting directly or indirectly from such moving, except, subject to Section 14.5 hereof, to the extent caused by the negligence or willful misconduct of any Landlord Parties. Proper placement of all Heavy Equipment in the Premises shall be Tenant’s responsibility.

10.5    Premises Cleaning. Tenant shall be responsible, at its sole cost and expense, for janitorial and trash removal services and other biohazard disposal services for the Premises, including the laboratory areas thereof. Such services shall be performed by licensed (where required by law or governmental regulation), insured and qualified contractors approved in advance, in writing, by Landlord (which approval shall not be unreasonably withheld, delayed or conditioned) and on a sufficient basis to ensure that the Premises are at all times kept neat and clean. Landlord shall provide a dumpster and/or compactor at the Building loading dock for Tenant’s disposal of non-biohazard material. All costs incurred by Landlord in connection with such dumpster and/or compactor shall be included in Operating Costs as provided in Section 5.2.

10.6    Pest Control. Tenant, at Tenant’s sole cost and expense, shall cause the Premises to be exterminated on a monthly basis to Landlord’s reasonable satisfaction and shall cause all portions of the Premises used for the storage, preparation, service or consumption of food or beverages to be cleaned daily in a manner reasonably satisfactory to Landlord, and to be treated

 

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against infestation by insects, rodents and other vermin and pests whenever there is evidence of any infestation. Tenant shall not permit any person to enter the Premises for the purpose of providing such extermination services, unless such persons have been approved by Landlord. If requested by Landlord, Tenant shall, at Tenant’s sole cost and expense, store any refuse generated in the Premises by the consumption of food or beverages in a cold box or similar facility.

10.7    Service Interruptions.

(a)    Abatement of Rent. In the event that: (i) there shall be an interruption, curtailment or suspension of any service or failure to perform any obligation required to be provided or performed by Landlord pursuant to Articles 9 and/or 10 (and no reasonably equivalent alternative service or supply is provided by Landlord) that shall materially interfere with Tenant’s use and enjoyment of the Premises, or any portion thereof (any such event, a “Service Interruption”), and (ii) such Service Interruption shall continue for five (5) consecutive business days following receipt by Landlord of written notice (the “Service Interruption Notice”) from Tenant describing such Service Interruption (“Abatement Service Interruption Cure Period”), and (iii) such Service Interruption shall not have been caused by an act or omission of Tenant or Tenant’s agents, employees, contractors or invitees (an event that satisfies the foregoing conditions (i)-(iii) being referred to hereinafter as a “Material Service Interruption”) then, Tenant, subject to the next following sentence, shall be entitled to an equitable abatement of Base Rent, Operating Costs and Taxes based on the nature and duration of the Material Service Interruption and the area of the Premises affected, for any and all days following the Material Service Interruption Cure Period that both (x) the Material Service Interruption is continuing and (y) Tenant does not use such affected areas of the Premises for any of the Permitted Uses. Any efforts by Tenant to respond or react to any Material Service Interruption, including, without limitation, any activities by Tenant to remove its personal property from the affected areas of the Premises, shall not constitute a use that precludes abatement pursuant to this Section 10.7(a). The Abatement Service Interruption Cure Period shall be extended by reason of any delays in Landlord’s ability to cure the Service Interruption in question caused by Landlord’s Force Majeure.

(b)    Tenant’s Termination Right. In the event that: (i) a Service Interruption occurs, and (ii) such Service Interruption continues for a period of one hundred twenty (120) consecutive days after Landlord receives a Service Interruption Notice with respect to such Service Interruption (“Termination Service Interruption Cure Period”), and (iii) such Service Interruption shall not have been caused by an act or omission of Tenant or Tenant’s agents, employees, contractors or invitees, and (iv) for so long as Tenant ceases to use the affected portion of the Premises during such Service Interruption, then Tenant shall have the right to terminate this Lease by giving a written termination notice to Landlord after the expiration of the Termination Service Interruption Cure Period. If such Service Interruption is cured within ten (10) days (“Post-Termination Notice Cure Period”) after Landlord receives such termination notice, then Tenant shall have no right to terminate this Lease based upon such Service Interruption and Tenant’s termination notice shall be of no force or effect. The Termination Service Interruption Cure Period and the Post-Termination Notice Cure Period shall each be extended by reason of any delays in Landlord’s ability to cure the Service Interruption in question caused by Landlord’s Force Majeure.

 

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(c)    The provisions of this Section 10.7 shall not apply in the event of a Service Interruption caused by Casualty or Taking (see Article 15 hereof).

(d)    The provisions of this Section 10.7 set forth Tenant’s sole rights and remedies, both in law and in equity, in the event of any Service Interruption.

11.    ALTERATIONS AND IMPROVEMENTS BY TENANT

11.1    Landlord’s Consent Required.

(a)    Tenant shall not make any alterations, decorations, installations, removals, additions or improvements (collectively, with the Tenant’s Work, “Alterations”) in or to the Premises without Landlord’s prior written approval of the contractor(s), written plans and specifications and a time schedule therefor. Landlord reserves the right to require that Tenant use Landlord’s preferred vendor(s) for any Alterations that involve roof penetrations, alarm tie-ins, sprinklers, fire alarm and other life safety equipment. Tenant shall not make any amendments or additions to plans and specifications approved by Landlord without Landlord’s prior written consent. Landlord’s approval of non-structural Alterations shall not be unreasonably withheld, conditioned or delayed. Notwithstanding the foregoing, Landlord may withhold its consent in its sole discretion (a) to any Alteration to or affecting the fixed lab benches, fume hoods, roof and/or building systems, (b) with respect to matters of aesthetics relating to Alterations to or affecting the exterior of the Building, and (c) to any Alteration affecting the Building structure. Tenant shall be responsible for all elements of the design of Tenant’s plans (including, without limitation, compliance with Legal Requirements, functionality of design, the structural integrity of the design, the configuration of the Premises and the placement of Tenant’s furniture, appliances and equipment), and Landlord’s approval of Tenant’s plans shall in no event relieve Tenant of the responsibility for such design. In seeking Landlord’s approval, Tenant shall provide Landlord, at least fourteen (14) days in advance of any proposed construction, with plans, specifications, bid proposals, certified stamped engineering drawings and calculations by Tenant’s engineer of record or architect of record, (including connections to the Building’s structural system, modifications to the Building’s envelope, non-structural penetrations in slabs or walls, and modifications or tie-ins to life safety systems), work contracts, requests for laydown areas and such other information concerning the nature and cost of the Alterations as Landlord may reasonably request. Landlord shall have no liability or responsibility for any claim, injury or damage alleged to have been caused by the particular materials (whether building standard or non-building standard), appliances or equipment selected by Tenant in connection with any work performed by or on behalf of Tenant. Except as otherwise expressly set forth herein, all Alterations shall be done at Tenant’s sole cost and expense and at such times and in such manner as Landlord may from time to time reasonably designate. If Tenant shall make any Alterations, then Landlord may elect to require Tenant at the expiration or sooner termination of the Term to restore the Premises to substantially the same condition as existed immediately prior to the Alterations. Tenant shall provide Landlord with reproducible record drawings (in CAD format) of all Alterations within sixty (60) days after completion thereof.

(b)    Alterations Permitted without Landlord’s Consent. Notwithstanding anything to the contrary herein contained, Tenant shall have the right without obtaining the prior consent of Landlord, but upon prior notice to Landlord as provided below, to make Alterations to

 

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the Premises where: (i) the same are within the interior of the Premises, and do not affect the exterior of the Building and do not affect any of the Building’s systems or the ceiling of the Premises; (ii) the same do not affect the roof or any structural element of the Building, or the fire protection systems of the Building; (iii) the same do not create a nuisance and do not interfere with the rights of other tenants located in the Building; (iv) the cost of any individual Alteration shall not exceed $75,000 in cost; (v) Tenant shall comply with the provisions of this Lease, and if such work increases the cost of insurance or taxes, Tenant shall pay for any such increase in cost; and (vi) Tenant gives Landlord at least five (5) business days’ prior notice describing such work in reasonable detail, accompanied by copies of plans and specifications therefor (to the extent plans and specifications are typically prepared in accordance with such work (the “Permitted Alterations”)).

11.2    After-Hours. Landlord and Tenant recognize that to the extent Tenant elects to perform some or all of the Alterations during times other than normal construction hours (i.e., Monday-Friday, 7:00 a.m. to 3:00 p.m., excluding holidays), Landlord may need to make arrangements to have supervisory personnel on site. Accordingly, Landlord and Tenant agree as follows: Tenant shall give Landlord at least two (2) business days’ prior written notice of any time outside of normal construction hours when Tenant intends to perform any Alterations (the “After-Hours Work”). Tenant shall reimburse Landlord, within thirty (30) days after demand therefor, for the cost of Landlord’s supervisory personnel overseeing the After-Hours Work. In addition, if construction during normal construction hours unreasonably disturbs other tenants of the Building, in Landlord’s sole discretion, Landlord may require Tenant to stop the performance of Alterations during normal construction hours and to perform the same after hours, subject to the foregoing requirement to pay for the cost of Landlord’s supervisory personnel.

11.3    Harmonious Relations. Tenant agrees that it will not, either directly or indirectly, use any contractors and/or materials if their use will create any difficulty, whether in the nature of a labor dispute or otherwise, with other contractors and/or labor engaged by Tenant or Landlord or others in the construction, maintenance and/or operation of the Building, the Property or any part thereof. In the event of any such difficulty, upon Landlord’s request, Tenant shall cause all contractors, mechanics or laborers causing such difficulty to leave the Property immediately.

11.4    Liens. No Alterations shall be undertaken by Tenant until (i) Tenant has made provision for written waiver of liens from all contractors for such Alteration; and (ii) with respect to any Alteration, the cost of which exceeds $500,000: (x) Tenant has provided Landlord with reasonable evidence that there is sufficient funding to pay for such Alteration, and (y) Tenant has required its general contractor to obtain appropriate surety payment and performance bonds which shall name Landlord as an additional obligee and has filed lien bond(s) (in jurisdictions where available) on behalf of such contractors. Any mechanic’s lien filed against the Premises or the Building for work claimed to have been done for, or materials claimed to have been furnished to, Tenant shall be discharged by Tenant within ten (10) business days thereafter, at Tenant’s expense by filing the bond required by law or otherwise.

11.5    General Requirements.

(a)    Unless Landlord and Tenant otherwise agree in writing, Tenant shall (a) procure or cause others to procure on its behalf all necessary permits before undertaking any

 

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Alterations in the Premises (and provide copies thereof to Landlord); (b) perform all of such Alterations in a good and workmanlike manner, employing materials of good quality and in compliance with Landlord’s construction rules and regulations, all insurance requirements of this Lease, and Legal Requirements; and (c) defend, indemnify and hold the Landlord Parties harmless from and against any and all Claims occasioned by or growing out of such Alterations, except, subject to Section 14.5 hereof, to the extent caused by the negligence or willful misconduct of any Landlord Parties.

(b)    In connection with the performance of any Alterations, Tenant (or Tenant’s contractor) shall develop and implement an indoor air quality management plan for the construction and preoccupancy phases of the Building and the Premises (a “Construction Indoor Air Quality Management Plan”). All Alterations performed by or on behalf of Tenant shall meet or exceed the requirements set forth in the Construction Indoor Air Quality Management Plan. During any construction, Tenant shall cause all of its contractors and subcontractors to, at a minimum, satisfy the following requirements: (w) satisfy the then-applicable standards and requirements outlined by the Sheet Metal and Air Conditioning National Contractors’ National Association (SMACNA) “Indoor Air Quality Guidelines for Occupied Buildings under Construction, 2nd Edition 2007, ANSI/SMACNA 008-2008” (Chapter 3); (x) in the event air handlers are used during construction, use MERV 8 filtration media at each return air grill as determined by ASHRAE 52.2-1999; (y) replace all filtration media prior to occupancy; and (z) protect stored on-site and installed absorptive materials from moisture damage.

(c)    In connection with the performance of any Alterations, Tenant (or Tenant’s contractor) shall develop and implement a construction waste management plan that identifies materials to be diverted from disposal and whether the materials will be sorted on-site or commingled. Such construction waste management plan must require, at a minimum, that Tenant or Tenant’s contractor recycle and/or salvage at least 75% of construction, demolition and packing debris by volume.

(d)    In connection with the performance of any Alterations, Tenant (or Tenant’s contractor) shall use products meeting the following criteria: (u) adhesives, sealants and sealant primers that do not exceed VOC content limits of South Coast Air Quality Management District Rule #1168 and aerosol adhesives that do not exceed VOC content limits of Green Seal Standard GC-36; (v) interior paints and coatings that meet “Topcoat Paints: Green Seal Standard GS-11, Paints,” “Anti-Corrosive and Anti-Rust Paints: Green Seal Standard GS-03, Anti-Corrosive Paints” and “All Other Architectural Coatings, Primers and Undercoats: South Coast Air Quality Management District Rule 1113, Architectural Coatings;” (w) non-carpet finished flooring that is FloorScore-certified; (x) carpet that meets the CRI Green Label Plus testing program, is 100% recyclable and contains at least 50% recycled content; (y) carpet padding that meets the CRI Green Label testing and product requirements, is 100% recyclable and contains at least 50% recycled content; and (z) carpet adhesive that has less than 50g/L VOC.

12.    SIGNAGE

12.1    Restrictions. Tenant shall have the right to install Building standard signage identifying Tenant’s business at the entrance to the Premises, which signage shall be subject to Landlord’s prior written consent (which consent shall not be unreasonably withheld, conditioned

 

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or delayed). Subject to the foregoing, and subject to Section 12.2 below, Tenant shall not, without first obtaining Landlord’s written approval place or suffer to be placed or maintained on the exterior of the Premises, or any part of the interior visible from the exterior thereof, any sign, banner, advertising matter or any other thing of any kind (including, without limitation, any hand-lettered advertising), and shall not place or maintain any decoration, letter or advertising matter on the glass of any window or door of the Premises without first obtaining Landlord’s written approval. No signs may be put on or in any window or elsewhere if visible from the exterior of the Building.

12.2    Monument Signage. For so long as (x) no Event of Default of Tenant then exists and (y) the Lease is in full force and effect (the “Monument Signage Condition”), then Tenant shall have the right to require Landlord to (i) list, at Landlord’s initial cost and expense, Tenant’s name (“Tenant’s Monument Signage”) on the existing exterior monument sign (the “Monument Sign”) serving the Property at the entrance from the MWF Road during the initial Term of the Lease, and any extensions thereof, subject to the provisions of this Section 12.2. The parties hereby agree that the maintenance and removal of such Tenant’s Monument Signage (including, without limitation, the repair and cleaning of the existing monument facade upon removal of Tenant’s Monument Signage) shall be performed by Landlord and the costs incurred by Landlord shall be included in Operating Costs in accordance with Section 5.2, except that Tenant shall be responsible for the cost of any change in Tenant’s Monument Signage during the initial Term of the lease.

12.3    Building Directory/Premises Entrance Signage.

(a)    Landlord shall list Tenant within the directory in the Building lobby. The initial listing shall be at Landlord’s cost and expense, and any changes to such directory listing shall be at Tenant’s cost and expense.

(b)    Tenant shall have the right, at Tenant’s cost to install a building standard Tenant identification sign at the entrance to the Premises.

13.    ASSIGNMENT, MORTGAGING AND SUBLETTING

13.1    Landlord’s Consent Required. Tenant shall not mortgage or encumber this Lease or in whole or in part whether at one time or at intervals, operation of law or otherwise. Except as expressly otherwise set forth herein, Tenant shall not, without Landlord’s prior written consent, assign, sublet, license or transfer this Lease or the Premises in whole or in part whether by changes in the ownership or control of Tenant, or any direct or indirect owner of Tenant, whether at one time or at intervals, by sale or transfer of stock, partnership or beneficial interests, operation of law or otherwise, or permit the occupancy of all or any portion of the Premises by any person or entity other than Tenant’s employees (each of the foregoing, a “Transfer”); provided, however, the provisions of this Article 13 shall not apply to (i) the transfer of ownership or control interests in Tenant if and so long as Tenant is publicly traded on a nationally recognized stock exchange, (ii) the transfer of ownership or control interests among the owners of Tenant existing as of the Effective Date provided that such transfer(s) of ownership interests do(es) not, either individually or in the aggregate, result in a change in Control of Tenant, (iii) the transfer of ownership interests to institutional or individual investors (including venture capital funding and corporate partners)

 

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which regularly invest in private biotechnology or life sciences companies provided that such transfer(s) of ownership interests do(es) not, either individually or in the aggregate, result in a change in Control of Tenant, or (iv) a public offering of the stock of Tenant on a national securities exchange. Any purported Transfer made without Landlord’s consent, if required hereunder, shall be void and confer no rights upon any third person, provided that if there is a Transfer, Landlord may collect rent from the transferee without waiving the prohibition against Transfers, accepting the transferee, or releasing Tenant from full performance under this Lease. In the event of any Transfer in violation of this Article 13, Landlord shall have the right to terminate this Lease upon thirty (30) days’ written notice to Tenant given within sixty (60) days after receipt of written notice from Tenant to Landlord of any Transfer, or within one (1) year after Landlord first learns of the Transfer if no notice is given. No Transfer shall relieve Tenant of its primary obligation as party Tenant hereunder, nor shall it reduce or increase Landlord’s obligations under this Lease. For purposes of this Section, “Control” shall mean the ownership, directly or indirectly, of 50% (or more than 50%) of the voting stock, partnership interests, membership interests, or beneficial ownership interest of Tenant, and/or the possession, directly or indirectly, of the power to direct or cause the direction of the day-to-day management and policies of Tenant.

13.2    Landlord’s Recapture Right

(a)    Except for Permitted Transfers, as provided in Section 13.7 below, and for Recapture-Exempt Subleases, as provided in Section 13.2(c) below, Tenant shall, prior to offering or advertising the Premises or any portion thereof for a Transfer, give a written notice (the “Recapture Notice”) to Landlord which: (i) states that Tenant desires to make a Transfer, (ii) identifies the affected portion of the Premises (the “Recapture Premises”), (iii) identifies the period of time (the “Recapture Period”) during which Tenant proposes to sublet the Recapture Premises, or indicates that Tenant proposes to assign its interest in this Lease, and (iv) offers to Landlord to terminate this Lease with respect to the Recapture Premises. Landlord shall have fifteen (15) business days within which to respond to the Recapture Notice.

(b)    Notwithstanding anything to the contrary contained herein, if Landlord notifies Tenant that it accepts the offer contained in the Recapture Notice or any subsequent Recapture Notice, Tenant shall have the right, for a period of fifteen (15) days following receipt of such notice from Landlord, time being of the essence, to notify Landlord in writing that it wishes to withdraw such offer and this Lease shall continue in full force and effect.

(c)    Subject to the provisions of this Article 13, including, without limitation, the standard of consent to a proposed Transfer set forth in Section 13.3 below, a proposed sublease of up to 4,000 square feet of the Premises Rentable Area for a sublease term that expires on or before the fifth (5th) anniversary of the Term Commencement Date (any such sublease, a “Recapture-Exempt Sublease”) shall be exempt from Landlord’s recapture right, as set forth in Section 13.2(a), above.

13.3    Standard of Consent to Transfer. If Landlord does not timely give written notice to Tenant accepting a Recapture Offer or declines to accept the same, then Landlord agrees that, subject to the provisions of this Article 13, Landlord shall not unreasonably withhold, condition or delay its consent to a Transfer at fair market rent and otherwise on the terms contained in the Recapture Notice to an entity which will use the Premises for any of the Permitted Uses and, in

 

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Landlord’s reasonable opinion: (a) has a tangible net worth and other financial indicators sufficient to meet the Transferee’s obligations under the Transfer instrument in question; (b) has a business reputation compatible with the operation of a first-class combination laboratory, research, development and office building; and (c) the intended use of such entity does not violate any restrictive use provisions then in effect with respect to space in the Building.

13.4    Listing Confers no Rights. The listing of any name other than that of Tenant, whether on the doors of the Premises or on the Building directory, or otherwise, shall not operate to vest in any such other person, firm or corporation any right or interest in this Lease or in the Premises or be deemed to effect or evidence any consent of Landlord, it being expressly understood that any such listing is a privilege extended by Landlord revocable at will by written notice to Tenant.

13.5    Profits In Connection with Transfers. Except with respect to Permitted Transfers, as defined in Section 13.7, Tenant shall, within thirty (30) days of receipt thereof, pay to Landlord fifty percent (50%) of any rent, sum or other consideration to be paid or given in connection with any Transfer, either initially or over time, after deducting reasonable actual out- of-pocket legal, architectural, engineering, brokerage expenses and rent concessions incurred by Tenant and unamortized improvements paid for by Tenant in connection therewith, in excess of Rent hereunder as if such amount were originally called for by the terms of this Lease as additional rent.

13.6    Prohibited Transfers. Notwithstanding any contrary provision of this Lease, Tenant shall have no right to make a Transfer unless on both (i) the date on which Tenant notifies Landlord of its intention to enter into a Transfer and (ii) the date on which such Transfer is to take effect, no Event of Default then exists under this Lease. Notwithstanding anything to the contrary contained herein, Tenant agrees that in no event shall Tenant make a Transfer to (a) any government agency; (b) any tenant, subtenant or occupant of other space in the Building if vacant space of a size comparable to the portion of the Premises subject to the Transfer then exists in the Building or will exist as of the commencement of the proposed Transfer; or (c) any entity with whom Landlord shall have negotiated for space in the Property in the three (3) months immediately preceding such proposed Transfer.

13.7    Exceptions to Requirement for Consent. Notwithstanding anything to the contrary herein contained, Tenant shall have the right, without obtaining Landlord’s consent and without giving Landlord a Recapture Notice, to (a) make a Transfer to an Affiliated Entity (hereinafter defined), and (b) assign all of Tenant’s interest in and to the Lease to a Successor, provided that prior to or simultaneously with any Transfer pursuant to this Section 13.7, such Affiliated Entity or Successor, as the case may be, and Tenant execute and deliver to Landlord an assignment and assumption agreement in form and substance reasonably acceptable to Landlord whereby such Affiliated Entity or Successor, as the case may be, shall agree to be independently bound by and upon all the covenants, agreements, terms, provisions and conditions set forth in the Lease on the part of Tenant to be performed, and whereby such Affiliated Entity or Successor, as the case may be, shall expressly agree that the provisions of this Article 13 shall, notwithstanding such Transfer, continue to be binding upon it with respect to all future Transfers. Additionally, Tenant shall have the right, without obtaining Landlord’s consent but upon not less than ten (10) days’ prior written notice to Landlord, to permit Affiliated Startup Entities (hereinafter defined) to occupy portions of the Premises from time to time during the Term, in each case on a temporary

 

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basis, without such occupancy constituting a Transfer hereunder (subject to the terms and conditions of this Lease, including without limitation Sections 4.1 and 4.2, above). For the purposes hereof, an “Affiliated Entity” shall be defined as any entity (a) that has a net worth and other financial indicators demonstrating such entity’s ability to perform all of Tenant’s obligations hereunder, as evidenced by audited financial statements; and (b) which is controlled by, is under common control with, or which controls Tenant. For the purposes hereof, a “Successor” shall be defined as any entity into or with which Tenant is merged or with which Tenant is consolidated or which acquires all or substantially all of Tenant’s stock or assets, provided that the surviving entity shall have a net worth and other financial indicators sufficient to meet Tenant’s obligations hereunder. Tenant shall give Landlord at least ten (10) days’ prior written notice of any Permitted Transfer (as hereinafter defined), such notice to include evidence, reasonably satisfactory to Landlord, that the conditions to the Permitted Transfer in question have been satisfied. Transfers to Affiliated Entities and to Successors which are permitted pursuant to this Section 13.7, are referred to collectively herein as “Permitted Transfers”, and such Affiliated Entities and Successors are referred to herein as “Permitted Transferees”. For the purposes hereof, an “Affiliated Startup Entity” shall be defined as a startup or early stage entity with which Tenant shares a business nexus.

14.    INSURANCE; INDEMNIFICATION; EXCULPATION

14.1    Tenant’s Insurance.

(a)    Tenant covenants and agrees that from and after the date of delivery of the Premises from Landlord to Tenant, Tenant will carry and maintain, at its sole cost and expense, the following types of insurance, in the amounts specified and in the form hereinafter provided for:

(i)    Commercial General Liability (“CGL”) Insurance written on an occurrence basis, covering the Premises and all operations of the Tenant in or about the Premises against claims for bodily injury, property damage and product liability and to include contractual liability coverage insuring Tenant’s indemnification obligations under this Lease, to be in combined single limits of not less than $1,000,000 each occurrence for bodily injury and property damage, $1,000,000 for products/completed operations aggregate, $1,000,000 for personal injury, and to have general aggregate limits of not less than $2,000,000 (per location) and Umbrella Liability Insurance in an amount not less than $5,000,000 for each policy year. The general aggregate limits under the Commercial General Liability insurance policy or policies shall apply separately to the Premises and to Tenant’s use thereof (and not to any other location or use of Tenant) and such policy shall contain an endorsement to that effect. The certificate of insurance evidencing the CGL form of policy shall specify all endorsements required herein and shall specify on the face thereof that the limits of such policy apply separately to the Premises.

(ii)    Insurance covering (i) all items or components of Alterations (collectively, the “Tenant-Insured Improvements”), and (ii) all of Tenant’s furniture, equipment, fixtures and property of every kind, nature and description related or arising out of Tenant’s leasehold estate hereunder, which may be in or upon the Premises or the Building (collectively, “Tenant’s Property”), in an amount not less than one hundred

 

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percent (100%) of their full replacement value from time to time during the Term, providing protection against perils included within the standard form of “all-risks” fire and casualty insurance policy. Any policy proceeds from such insurance shall be held in trust by Tenant’s insurance company for the repair, construction and restoration or replacement of the property damaged or destroyed unless this Lease shall cease and terminate under the provisions of Article 15 of this Lease. The insurance required to be maintained by Tenant pursuant to this Section 14.1(a)(ii) is referred to herein as “Tenant Property Insurance.”

(iii)    Workers’ Compensation and Employer’s Liability insurance affording statutory coverage and containing statutory limits with the Employer’s Liability portion thereof to have minimum limits of $1,000,000.00.

(iv)    Business Interruption Insurance with limits not less than an amount equal to one (1) year’s revenue hereunder of Tenant at the Premises which insurance shall be issued on an “all risks” basis (or its equivalent).

(b)    All policies of the insurance provided for in this Section 14.1 (collectively, as “Tenant’s Insurance Policies”) shall be issued in form acceptable to Landlord by insurance companies with a rating and financial size of not less than A IX in the most current available “Best’s Insurance Reports”, and licensed to do business in the state in which the Building is located. Each and every such policy:

(i)    shall include Landlord as an additional insured (as well as any mortgagee of Landlord and any other party reasonably designated by Landlord), except with respect to the insurance described in Section 14.1(a)(iii) above;

(ii)    shall (and a certificate thereof shall be delivered to Landlord at or prior to the delivery of possession of the Premises) be delivered to each of Landlord and any such other parties in interest within thirty (30) days after delivery of possession of the Premises to Tenant and thereafter within five (5) days after the inception (or renewal) of each new policy, and as often as any such policy shall expire or terminate. Renewal or additional policies shall be procured and maintained by Tenant in like manner and to like extent;

(iii)    shall contain a provision that the insurer will give to Landlord and such other parties in interest at least thirty (30) days’ notice in writing by insurers (and ten days in the case of non-payment) in advance of any material change, cancellation, termination or lapse, or the effective date of any reduction in the amounts of insurance;

(iv)    shall include deductibles in an amount no greater than $25,000; and

(v)    shall be written as a primary policy which does not contribute to and is not in excess of coverage which Landlord may carry.

 

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(c)    Any insurance provided for in Section 14.1(a) may be maintained by means of a policy or policies of blanket insurance, covering additional items or locations or insureds, provided, however, that:

(i)    Landlord and any other parties in interest from time to time designated by Landlord to Tenant shall be named as an additional insured thereunder as its interest may appear;

(ii)    the coverage afforded Landlord and any such other parties in interest will not be reduced or diminished by reason of the use of such blanket policy of insurance; and

(iii)    the requirements set forth in this Article 14 are otherwise satisfied.

(d)    During periods when Tenant’s Work and/or any Alterations are being performed, Tenant shall maintain, or cause to be maintained, so-called all risk or special cause of loss property insurance or its equivalent and/or builders risk insurance on 100% replacement cost coverage basis, including hard and soft costs coverages. Such insurance shall protect and insure Landlord, Landlord’s agents, Tenant and Tenant’s contractors, as their interests may appear, against loss or damage by fire, water damage, vandalism and malicious mischief, and such other risks as are customarily covered by so-called all risk or special cause of loss property / builders risk coverage or its equivalent.

(e)    Tenant shall procure and maintain at its sole expense such additional insurance as may be necessary to comply with any Legal Requirements.

(f)    Tenant shall cause all contractors and subcontractors to maintain during the performance of any Alterations the insurance described in Exhibit 10 attached hereto.

(g)    In the event of any claim, and upon Landlord’s request, Tenant shall deliver to Landlord complete copies of Tenant’s Insurance Policies. Upon request of Landlord, Tenant shall deliver to any Mortgagee copies of the foregoing documents.

14.2    Indemnification. Except to the extent caused by the negligence or willful misconduct of any of the Landlord Parties, Tenant shall defend, indemnify and save the Landlord Parties harmless from and against any and all Claims asserted by or on behalf of any person, firm, corporation or public authority arising from:

(a)    Tenant’s breach of any covenant or obligation under this Lease;

(b)    Any injury to or death of any person, or loss of or damage to property, sustained or occurring in, upon, or at the Premises;

(c)    Any injury to or death of any person, or loss of or damage to property arising out of the use or occupancy of the Premises by or the negligence or willful misconduct of any of the Tenant Parties; and

(d)    On account of or based upon any work or thing whatsoever done (other than by Landlord or any of the Landlord Parties) at the Premises during the Term and during the period of time, if any, prior to the Term Commencement Date that any of the Tenant Parties may have been given access to the Premises.

 

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14.3    Property of Tenant. Tenant covenants and agrees that, to the maximum extent permitted by Legal Requirements, all of Tenant’s Property at the Premises shall be at the sole risk and hazard of Tenant, and that if the whole or any part thereof shall be damaged, destroyed, stolen or removed from any cause or reason whatsoever, no part of said damage or loss shall be charged to, or borne by, Landlord, except, subject to Section 14.5 hereof, to the extent such damage or loss is due to the negligence or willful misconduct of any of the Landlord Parties.

14.4    Limitation of Landlord’s Liability for Damage or Injury. Landlord shall not be liable for any injury or damage to persons or property resulting from fire, explosion, falling plaster, steam, gas, air contaminants or emissions, electricity, electrical or electronic emanations or disturbance, water, rain or snow or leaks from any part of the Building or from the pipes, appliances, equipment or plumbing works or from the roof, street or sub-surface or from any other place or caused by dampness, vandalism, malicious mischief or by any other cause of whatever nature, except, subject to Section 14.5, to the extent caused by or due to the negligence or willful misconduct of any of the Landlord Parties, and then, where notice and an opportunity to cure are appropriate (i.e., where Tenant has an opportunity to know of such condition sufficiently in advance of the occurrence of any such injury or damage resulting therefrom as would have enabled Landlord to prevent such damage or loss had Tenant notified Landlord of such condition) only after (i) notice to Landlord of the condition claimed to constitute negligence or willful misconduct, and (ii) the expiration of a reasonable time after such notice has been received by Landlord without Landlord having commenced to take all reasonable and practicable means to cure or correct such condition. Notwithstanding the foregoing, in no event shall any of the Landlord Parties be liable for any loss which is covered by insurance policies actually carried or required to be so carried by this Lease; nor shall any of the Landlord Parties be liable for any such damage caused by other tenants or persons in the Building or caused by operations in construction of any private, public, or quasi-public work; nor shall any of the Landlord Parties be liable for any latent defect in the Premises or in the Building.

14.5    Waiver of Subrogation; Mutual Release. Landlord and Tenant each hereby waives on behalf of itself and its property insurers (none of which shall ever be assigned any such claim or be entitled thereto due to subrogation or otherwise) any and all rights of recovery, claim, action, or cause of action against the other and its agents, officers, servants, partners, shareholders, or employees (collectively, the “Related Parties”) for any loss or damage that may occur to or within the Premises or the Building or any improvements thereto, or any personal property of such party therein which is insured against under any Property Insurance (as defined in Section 14.7) policy actually being maintained by the waiving party from time to time, even if not required hereunder, or which would be insured against under the terms of any Property Insurance policy required to be carried or maintained by the waiving party hereunder, whether or not such insurance coverage is actually being maintained, including, in every instance, such loss or damage that may be caused by the negligence of the other party hereto and/or its Related Parties. Landlord and Tenant each agrees to cause appropriate clauses to be included in its Property Insurance policies necessary to implement the foregoing provisions.

14.6    Tenant’s Acts—Effect on Insurance. Tenant shall not do or permit any Tenant Party to do any act or thing upon the Premises or elsewhere in the Building which will invalidate or be in conflict with any insurance policies covering the Building and the fixtures and property therein; and shall not do, or permit to be done, any act or thing upon the Premises which shall

 

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subject Landlord to any liability or responsibility for injury to any person or persons or to property by reason of any business or operation being carried on upon said Premises or for any other reason. Notwithstanding anything to the contrary contained herein, Tenant shall not be liable for any increases in the rate of insurance unless such increases arise from Tenant’s manner of use of the Premises (as opposed to Tenant’s use of the Premises for the Permitted Uses). If by reason of the failure of Tenant to comply with the provisions hereof the insurance rate applicable to any policy of insurance shall at any time thereafter be higher than it otherwise would be, Tenant shall reimburse Landlord within thirty (30) days of Landlord’s written demand for that part of any insurance premiums which shall have been charged because of such failure by Tenant, together with interest at the Default Rate until paid in full, within thirty (30) days after receipt of an invoice therefor. In addition, Tenant shall reimburse Landlord for any increase in insurance premium arising as a result of Tenant’s use and/or storage of any Hazardous Materials in the Premises.

14.7    Landlord’s Insurance. Landlord shall carry at all times during the Term of this Lease: (i) commercial general liability insurance with respect to the Building, the Land and the Common Areas thereof in an amount not less than Five Million Dollars ($5,000,000) combined single limit per occurrence, (ii) with respect to the Building, excluding Tenant-Insured Improvements and improvements made by other tenants or occupants, insurance against loss or damage caused by any peril covered under fire, extended coverage and all risk insurance with coverage against vandalism, malicious mischief and such other insurable hazards and contingencies as are from time to time normally insured against by owners of similar first-class multi-tenant buildings in the City of Waltham or which are required by Landlord’s mortgagee, in an amount equal to one hundred percent (100%) of the full replacement cost thereof above foundation walls (“Landlord Property Insurance”), and (iii) rent interruption insurance covering at least twelve (12) months. Any and all such insurance: (x) may be maintained under a blanket policy affecting other properties of Landlord and/or its affiliated business organizations, and (y) may be written with commercially reasonable deductibles as determined by Landlord. The costs incurred by Landlord related to such insurance shall be included in Operating Costs. Tenant Property Insurance and Landlord Property Insurance are referred to collectively herein as “Property Insurance”.

15.    CASUALTY; TAKING

15.1    Damage. If the Premises are damaged in whole or part because of fire or other insured casualty (“Casualty”), or if the Premises are subject to a taking in connection with the exercise of any power of eminent domain, condemnation, or purchase under threat or in lieu thereof (any of the foregoing, a “Taking”), then unless this Lease is terminated in accordance with Section 15.2 below, Landlord shall restore the Building and/or the Premises to substantially the same condition as existed as of the Term Commencement Date, or in the event of a partial Taking which affects the Building and the Premises, restore the remainder of the Building and the Premises not so Taken to substantially the same condition as is reasonably feasible. Landlord shall, within sixty (60) days after any Casualty, deliver to Tenant an engineering estimate (the “Restoration Estimate”) from a reputable contractor engineer, setting forth an estimate of the period of time (the “Restoration Period”) that it will take for Landlord to restore the Building and/or Premises, as aforesaid. If, in Landlord’s reasonable judgment, any element of the Tenant-Insured Improvements can more effectively be restored as an integral part of Landlord’s restoration of the Building or the Premises, such restoration shall also be made by Landlord, but at Tenant’s sole

 

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cost and expense. Subject to rights of Mortgagees, Tenant Delays, Legal Requirements then in existence and to delays for adjustment of insurance proceeds or Taking awards, as the case may be, and instances of Force Majeure, Landlord shall substantially complete such restoration within one (1) year after Landlord’s receipt of all required permits therefor with respect to substantial reconstruction of at least fifty percent (50%) of the Building, or, within one hundred eighty (180) days after Landlord’s receipt of all required permits therefor in the case of restoration of less than fifty (50%) of the Building. Upon substantial completion of such restoration by Landlord, Tenant shall use diligent efforts to complete restoration of the Premises to substantially the same condition as existed immediately prior to such Casualty or Taking, as the case may be, as soon as reasonably possible. Tenant agrees to cooperate with Landlord in such manner as Landlord may reasonably request to assist Landlord in collecting insurance proceeds due in connection with any Casualty which affects the Premises or the Building. In no event shall Landlord be required to expend more than the Net (hereinafter defined) insurance proceeds Landlord receives for damage to the Premises and/or the Building or the Net Taking award attributable to the Premises and/or the Building. “Net” means the insurance proceeds or Taking award actually paid to Landlord (and not paid over to a Mortgagee) less all costs and expenses, including adjusters and attorney’s fees, of obtaining the same. In the Operating Year in which a Casualty occurs, there shall be included in Operating Costs Landlord’s deductible under its property insurance policy. Except as Landlord may elect pursuant to this Section 15.1, under no circumstances shall Landlord be required to repair any damage to, or make any repairs to or replacements of, any Tenant-Insured Improvements.

15.2    Termination Rights.

(a)    Landlord’s Termination Rights. Landlord may terminate this Lease upon thirty (30) days’ prior written notice to Tenant if:

(i)    any material portion of the Building or any material means of access thereto is taken;

(ii)    more than thirty-five percent (35%) of the Building is damaged by Casualty; or

(iii)    if the estimated time to complete restoration exceeds one (1) year from the date on which Landlord receives all required permits for such restoration.

(b)    Tenant’s Termination Right. Tenant may terminate this Lease upon thirty (30) days’ prior written notice to Landlord if:

(i)    any material portion of the Premises or any material means of access thereto is taken, so that, in Tenant’s reasonable judgment, the continued operation of Tenant’s business in the Premises is materially adversely affected;

(ii)    if 50% or more of the Building is damaged by a Casualty and the estimated Restoration Period, as set forth in the Restoration Estimate, exceeds one (1) year from the date on which Landlord receives all required permits for such restoration; or

 

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(iii)    if less than 50% of the Building is damaged by a Casualty, Tenant’s use of and/or access to the Premises is materially adversely affected by such Casualty, and the estimated Restoration Period, as set forth in the Restoration Estimate, exceeds nine (9) months from the date on which Landlord receives all required permits for such restoration; or

(iv)    Landlord is so required but fails to complete restoration of the Premises within the time frames and subject to the conditions set forth in Section 15.1 above, then Tenant may terminate this Lease upon thirty (30) days’ written notice to Landlord; provided, however, that if Landlord completes such restoration within thirty (30) days after receipt of any such termination notice, such termination notice shall be null and void and this Lease shall continue in full force and effect. The remedies set forth in this Section 15.2(b) and in Section 15.2(c) below are Tenant’s sole and exclusive rights and remedies based upon Landlord’s failure to complete the restoration of the Premises as set forth herein. Notwithstanding anything to the contrary contained herein, Tenant shall not have the right to terminate this Lease pursuant to this Article 15 if the Casualty was caused by the gross negligence or willful misconduct of any Tenant Party.

(c)    Either Party May Terminate. In the case of any Casualty or Taking affecting the Premises and occurring during the last twelve (12) months of the Term, then (i) if such Casualty or Taking results in more than twenty-five percent (25%) of the floor area of the Premises being unsuitable for the Permitted Uses, or (ii) the damage to the Premises costs more than $250,000 to restore, then either Landlord or Tenant shall have the option to terminate this Lease upon thirty (30) days’ written notice to the other. In addition, if Landlord’s Mortgagee does not release sufficient insurance proceeds to cover the cost of Landlord’s restoration obligations, then Landlord shall (i) notify Tenant thereof, and (ii) have the right to terminate this Lease. If Landlord does not terminate this Lease pursuant to the previous sentence and such notice by Landlord does not include an agreement by Landlord to pay for the difference between the cost of such restoration and such released insurance proceeds, then Tenant may terminate this Lease by written notice to Landlord on or before the date that is thirty (30) days after such notice. Notwithstanding anything to the contrary contained in this Article 15, in no event may Tenant elect to terminate this Lease hereunder if the Casualty that would otherwise give rise to such right results from the gross negligence or willful misconduct of Tenant, its agents, contractors, or employees.

(d)    Automatic Termination. In the case of a Taking of the entire Premises, then this Lease shall automatically terminate as of the date of possession by the Taking authority.

15.3    Rent Abatement. In the event of a Casualty affecting the Premises, there shall be an equitable adjustment of Base Rent, Operating Costs and Taxes based upon the degree to which Tenant’s ability to conduct its business in the Premises is impaired by reason of such Casualty from and after the date of a Casualty, and continuing until the following portions of the repair and restoration work to be performed by Landlord, as set forth above, are substantially completed: (i) any repair and restoration work to be performed by Landlord within the Premises, and (ii) repair and restoration work with respect to the Common Areas to the extent that damage to the Common Areas caused by such Casualty materially adversely affects Tenant’s use of, or access to, the Premises.

 

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15.4    Taking for Temporary Use. If the Premises are Taken for temporary use, this Lease and Tenant’s obligations, including without limitation the payment of Rent, shall continue. For purposes hereof, a “Taking for temporary use” shall mean a Taking of ninety (90) days or less.

15.5    Disposition of Awards. Except for any separate award for Tenant’s movable trade fixtures, relocation expenses, and unamortized leasehold improvements paid for by Tenant (provided that the same may not reduce Landlord’s award), all Taking awards to Landlord or Tenant shall be Landlord’s property without Tenant’s participation, and Tenant hereby assigns to Landlord Tenant’s interest, if any, in such award. Tenant may pursue its own claim against the Taking authority.

16.    ESTOPPEL CERTIFICATE.

Tenant shall at any time and from time to time upon not less than ten (10) business days’ prior written notice from Landlord, execute, acknowledge and deliver to Landlord a statement in writing certifying that this Lease is unmodified and in full force and effect (or if there have been modifications, that the same is in full force and effect as modified and stating the modifications), and the dates to which Rent has been paid in advance, if any, stating to Tenant’s knowledge whether or not Landlord is in default in performance of any covenant, agreement, term, provision or condition contained in this Lease and, if so, specifying each such default, and such other facts as Landlord may reasonably request, it being intended that any such statement delivered pursuant hereto may be relied upon by Landlord, any prospective purchaser of the Building or of any interest of Landlord therein, any Mortgagee or prospective Mortgagee thereof, any lessor or prospective lessor thereof, any lessee or prospective lessee thereof, or any prospective assignee of any mortgage thereof. Time is of the essence with respect to any such requested certificate, Tenant hereby acknowledging the importance of such certificates in mortgage financing arrangements, prospective sales and the like.

17.    HAZARDOUS MATERIALS

17.1    Prohibition. Tenant shall not, without the prior written consent of Landlord, bring or permit to be brought or kept in or on the Premises or elsewhere in the Building or the Property (i) any inflammable, combustible or explosive fluid, material, chemical or substance (except for standard office supplies stored in proper containers); and (ii) any Hazardous Material (hereinafter defined), other than the types and quantities of Hazardous Materials which are listed on Exhibit 8 attached hereto (“Tenant’s Hazardous Materials”), provided that the same shall at all times be brought upon, kept or used in so-called ‘control areas’ (the number and size of which shall be shown Exhibit 8-1) and in accordance with all applicable Legal Requirements, including, without limitation, Environmental Laws (hereinafter defined), and prudent environmental practice and (with respect to medical waste and so-called “biohazard” materials) good scientific and medical practice. Tenant shall be responsible for assuring that all laboratory uses are adequately and properly vented. On or before each anniversary of the Rent Commencement Date, and on any earlier date during the 12-month period on which Tenant intends to add a new Hazardous Material or materially increase the quantity of any Hazardous Material to the list of Tenant’s Hazardous Materials, Tenant shall submit to Landlord an updated list of Tenant’s Hazardous Materials for Landlord’s review and approval, which approval shall not be unreasonably withheld, conditioned

 

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or delayed. Landlord shall have the right, from time to time, to inspect the Premises for compliance with the terms of this Section 17.1. Notwithstanding the foregoing, with respect to any of Tenant’s Hazardous Materials which Tenant does not properly handle, store or dispose of in compliance with all applicable Environmental Laws (hereinafter defined), prudent environmental practice and (with respect to medical waste and so-called “biohazard materials”) good scientific and medical practice, Tenant shall, upon written notice from Landlord, no longer have the right to bring such material into the Building or the Property until Tenant has demonstrated, to Landlord’s reasonable satisfaction, that Tenant has implemented programs to thereafter properly handle, store or dispose of such material. In order to induce Landlord to waive its otherwise applicable requirement that Tenant maintain insurance in favor of Landlord against liability arising from the presence of radioactive materials in the Premises, and without limiting the foregoing, Tenant hereby represents and warrants to Landlord that at no time during the Term will Tenant bring upon, or permit to be brought upon, the Premises any radioactive materials whatsoever.

17.2    Environmental Laws. For purposes hereof, “Environmental Laws” shall mean all laws, statutes, ordinances, rules and regulations of any local, state or federal governmental authority having jurisdiction concerning environmental, health and safety matters, including but not limited to any discharge by any of the Tenant Parties into the air, surface water, sewers, soil or groundwater of any Hazardous Material (hereinafter defined) whether within or outside the Premises, including, without limitation (a) the Federal Water Pollution Control Act, 33 U.S.C. Section 1251 et seq., (b) the Federal Resource Conservation and Recovery Act, 42 U.S.C. Section 6901 et seq., (c) the Comprehensive Environmental Response, Compensation and Liability Act, 42 U.S.C. Section 9601 et seq., (d) the Toxic Substances Control Act of 1976, 15 U.S.C. Section 2601 et seq., and (e) Chapter 21E of the General Laws of Massachusetts. Tenant, at its sole cost and expense, shall comply with (i) Environmental Laws, and (ii) any rules, requirements and safety procedures of the Massachusetts Department of Environmental Protection, the City of Waltham and any insurer of the Building or the Premises with respect to Tenant’s use, storage and disposal of any Hazardous Materials.

17.3    Hazardous Material Defined. As used herein, the term “Hazardous Material” means asbestos, oil or any hazardous, radioactive or toxic substance, material or waste or petroleum derivative which is or becomes regulated by any Environmental Law, including without limitation live organisms, viruses and fungi, medical waste and any so-called “biohazard” materials. The term “Hazardous Material” includes, without limitation, oil and/or any material or substance which is (i) designated as a “hazardous substance,” “hazardous material,” “oil,” “hazardous waste” or toxic substance under any Environmental Law.

17.4    Chemical Safety Program. Tenant shall establish and maintain a chemical safety program administered by a licensed, qualified individual in accordance with the requirements of any applicable governmental authority. Tenant shall be solely responsible for all costs incurred in connection with such chemical safety program, and Tenant shall provide Landlord with such documentation as Landlord may reasonably require evidencing Tenant’s compliance with the requirements of (a) any applicable governmental authority with respect to such chemical safety program and (b) this Section. Tenant shall obtain and maintain during the Term any permit required by any such applicable governmental authority.

 

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17.5    Testing. If any Mortgagee or governmental authority requires testing to determine whether there has been any release of Hazardous Materials and such testing is required as a result of the acts or omissions of any of the Tenant Parties in violation of this Lease, then Tenant shall reimburse Landlord within thirty (30) days of Landlord’s written demand, as additional rent, for the reasonable costs thereof, together with interest at the Default Rate until paid in full. Tenant shall execute affidavits, certifications and the like, as may be reasonably requested by Landlord from time to time concerning Tenant’s best knowledge and belief concerning the presence of Hazardous Materials in or on the Premises, the Building or the Property. In addition to the foregoing, if Landlord reasonably believes that any Hazardous Materials have been released on the Premises in violation of this Lease or any Legal Requirement, Landlord shall have the right to conduct appropriate tests of the Premises or any portion thereof to demonstrate that Hazardous Materials are present or that contamination has occurred due to the acts or omissions of any of the Tenant Parties in violation of this Lease. Tenant shall pay all reasonable costs of such tests if such tests reveal that Hazardous Materials exist at the Premises in violation of this Lease or any Legal Requirement. Further, Landlord shall have the right to cause a third party consultant retained by Landlord, at Landlord’s expense (provided, however, that such costs shall be included in Operating Costs, if allowed pursuant to Section 5.2), to review, but not more than once in any calendar year, Tenant’s lab operations, procedures and permits to ascertain whether or not Tenant is complying with law and adhering to best industry practices. Tenant agrees to cooperate in good faith with any such review and to provide to such consultant any information requested by such consultant and reasonably required in order for such consultant to perform such review, but nothing contained herein shall require Tenant to provide proprietary or confidential information to such consultant.

17.6    Indemnity; Remediation.

(a)    Tenant hereby covenants and agrees to indemnify, defend and hold the Landlord Parties harmless from and against any and all Claims against any of the Landlord Parties arising out of contamination of any part of the Property or other adjacent property, which contamination arises as a result of: (i) the presence of Hazardous Material in the Premises, the presence of which is caused by any act or omission of any of the Tenant Parties, or (ii) from a breach by Tenant of its obligations under this Article 17. This indemnification of the Landlord Parties by Tenant includes, without limitation, reasonable costs incurred in connection with any investigation of site conditions or any cleanup, remedial, removal or restoration work or any other response actions required by any federal, state or local governmental agency or political subdivision because of Hazardous Material present in the soil, soil vapor or ground water on or under or any indoor air in the Building based upon the circumstances identified in the first sentence of this Section 17.6. The indemnification and hold harmless obligations of Tenant under this Section 17.6 shall survive the expiration or any earlier termination of this Lease. Without limiting the foregoing, if the presence of any Hazardous Material in the Building or otherwise in the Property is caused or permitted by any of the Tenant Parties and results in any contamination of any part of the Property or any adjacent property, Tenant shall promptly take all actions at Tenant’s sole cost and expense as are necessary to return the Property and/or the Building or any adjacent property to their condition as of the date of this Lease, provided that Tenant shall first obtain Landlord’s written approval of such actions, which approval shall not be unreasonably withheld, conditioned or delayed so long as such actions, in Landlord’s reasonable discretion, would not potentially have any adverse effect on the Property, and, in any event, Landlord shall not withhold its approval of any proposed actions which are required by applicable Environmental Laws. The provisions of this Section 17.6 shall survive the expiration or earlier termination of the Lease.

 

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(b)    Without limiting the obligations set forth in Section 17.6(a) above, if any Hazardous Material is in, on, under, at or about the Building or the Property as a result of the acts or omissions of any of the Tenant Parties and results in any contamination of any part of the Property or any adjacent property that is in violation of any applicable Environmental Law or that requires the performance of any response action pursuant to any Environmental Law, Tenant shall promptly take all actions at Tenant’s sole cost and expense as are necessary to reduce such Hazardous Material to amounts below any applicable Reportable Quantity, any applicable Reportable Concentration and any other applicable standard set forth in any Environmental Law such that no further response actions are required; provided that Tenant shall first obtain Landlord’s written approval of such actions, which approval shall not be unreasonably withheld, conditioned or delayed so long as such actions would not be reasonably expected to have an adverse effect on the market value or utility of the Property for the Permitted Uses, and in any event, Landlord shall not withhold its approval of any proposed actions which are required by applicable Environmental Laws (such approved actions, “Tenant’s Remediation”).

(c)    In the event that Tenant fails to complete Tenant’s Remediation prior to the end of the Term, then:

(i)    until the completion of Tenant’s Remediation (as evidenced by the certification of Tenant’s Licensed Site Professional (as such term is defined by applicable Environmental Laws), who shall be reasonably acceptable to Landlord) (the “Remediation Completion Date”), Tenant shall pay to Landlord, with respect to the portion of the Premises which reasonably cannot be occupied by a new tenant until completion of Tenant’s Remediation, (A) Additional Rent on account of Operating Costs and Taxes and (B) Base Rent in an amount equal to the greater of (1) the fair market rental value of such portion of the Premises (determined in substantial accordance with the process described in Section 1.2 above), and (2) Base Rent attributable to such portion of the Premises in effect immediately prior to the end of the Term; and

(ii)    Tenant shall maintain responsibility for Tenant’s Remediation and Tenant shall complete Tenant’s Remediation as soon as reasonably practicable in accordance with Environmental Laws. If Tenant does not diligently pursue completion of Tenant’s Remediation, Landlord shall have the right to either (A) assume control for overseeing Tenant’s Remediation, in which event Tenant shall pay all reasonable costs and expenses of Tenant’s Remediation (it being understood and agreed that all costs and expenses of Tenant’s Remediation incurred pursuant to contracts entered into by Tenant shall be deemed reasonable) within thirty (30) days of demand therefor (which demand shall be made no more often than monthly), and Landlord shall be substituted as the party identified on any governmental filings as the party responsible for the performance of such Tenant’s Remediation or (B) require Tenant to maintain responsibility for Tenant’s Remediation, in which event Tenant shall complete Tenant’s Remediation as soon as reasonably practicable in accordance with Environmental Laws, it being understood that Tenant’s Remediation shall not contain any requirement that Tenant remediate any contamination to levels or standards more stringent than those associated with the Property’s current office, research and development, laboratory, and vivarium uses.

 

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(d)    The provisions of this Section 17.6 shall survive the expiration or earlier termination of this Lease.

17.7    Disclosures. Prior to bringing any Hazardous Material into any part of the Property, Tenant shall deliver to Landlord the following information with respect thereto: (a) a description of handling, storage, use and disposal procedures; (b) all plans or disclosures and/or emergency response plans which Tenant has prepared, including without limitation Tenant’s Spill Response Plan, and all plans which Tenant is required to supply to any governmental agency or authority pursuant to any Environmental Laws; (c) copies of all Required Permits relating thereto; and (d) other information reasonably requested by Landlord.

17.8    Removal. Tenant shall be responsible, at its sole cost and expense, for Hazardous Material and other biohazard disposal services for the Premises. Such services shall be performed by contractors reasonably acceptable to Landlord and on a sufficient basis to ensure that the Premises are at all times kept neat, clean and free of Hazardous Materials and biohazards except in appropriate, specially marked containers reasonably approved by Landlord.

17.9    Landlord Obligations with respect to Hazardous Materials.

(a)    Landlord Representations, Covenants and Indemnity. Landlord hereby represents and warrants to Tenant that, to the Best of Landlord’s Knowledge (as that term is defined in clause (c) below), except to the extent (if any) as may be disclosed in the following described environmental assessment reports which have been made available by Landlord to Tenant (the “Disclosed Materials”), there exist, as of the Execution Date of this Lease, no Hazardous Materials on the Property which are in violation of applicable Environmental Laws or that require reporting, investigation, remediation or other response under Chapter 21E or other Environmental Laws:

 

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Phase I Environmental Site Assessment, 830 Winter Street, Waltham, Massachusetts, prepared by Boston Environmental Corporation, dated June 26, 2015.

Landlord covenants that neither Landlord nor any of the Landlord Parties shall bring any Hazardous Materials in or on to the Property or discharge any Hazardous Materials in or on to the Property which are, in either case, in violation of applicable Environmental Laws. Landlord hereby indemnifies and shall defend and hold Tenant, its officers, directors, employees, and agents harmless from any Claims arising as result of any breach by Landlord of its representations, warranties, or covenants under this Section 17.9(a).

(b)    Landlord Remediation. If Hazardous Materials are discovered in, on or under the Property which are not in compliance with applicable Environmental Laws or that require reporting, investigation, remediation or other response under Chapter 21E or other Environmental Laws, and which are not the responsibility of Tenant pursuant to this Article 17, then Landlord shall remove or remediate, or cause to be removed or remediated, the same, when, if, and in the manner required by applicable Environmental Laws.

 

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(c)    To the Best of Landlord’s Knowledge. The phrase “to the Best of Landlord’s Knowledge” under shall mean the best of the knowledge of Xave Jacoby, Landlord’s asset manager with respect to the Property.

18.    RULES AND REGULATIONS.

18.1    Rules and Regulations. Tenant will faithfully observe and comply with the Rules and Regulations attached hereto as Exhibit 9 (“Current Rules and Regulations”) and reasonable rules and regulations as may be promulgated, from time to time, with respect to the Building, the Property and construction within the Property (collectively, the “Rules and Regulations”). The Current Rules and Regulations consist of the Building Rules and Regulations attached hereto as Exhibit 9-1 and the Construction Rules and Regulations attached hereto as Exhibit 9-2. In the case of any conflict between the provisions of this Lease and any future rules and regulations, the provisions of this Lease shall control. Nothing contained in this Lease shall be construed to impose upon Landlord any duty or obligation to enforce the Rules and Regulations or the terms, covenants or conditions in any other lease as against any other tenant and Landlord shall not be liable to Tenant for violation of the same by any other tenant, its servants, employees, agents, contractors, visitors, invitees or licensees.

18.2    Energy Conservation. Landlord may institute upon written notice to Tenant such policies, programs and measures as may be necessary, required, or expedient for the conservation and/or preservation of energy or energy services (collectively, the “Conservation Program”), provided however, (i) that the Conservation Program does not, by reason of such policies, programs and measures, reduce the level of energy or energy services being provided to the Premises below the level of energy or energy services then being provided in comparable combination laboratory, research and development and office buildings in the vicinity of the Premises, provided the same shall not come at a material cost to Tenant, or materially adversely affect Tenant’s use of the Premises for any of the Permitted Uses, or (ii) or as may be necessary or required to comply with Legal Requirements or standards or the other provisions of this Lease. Upon receipt of such notice, Tenant shall comply with the Conservation Program.

18.3    Recycling. Upon written notice, Landlord may establish policies, programs and measures for the recycling of paper, products, plastic, tin and other materials (a “Recycling Program”). Upon receipt of such notice, Tenant will comply with the Recycling Program at Tenant’s sole cost and expense.

19.    LAWS AND PERMITS.

19.1    Legal Requirements. Tenant shall not cause or permit the Premises, or cause the Property or the Building to be used in any way that violates any Legal Requirement, order, permit, approval, variance, covenant or restrictions of record or any provisions of this Lease, interferes with the rights of tenants of the Building, or constitutes a nuisance or waste. Tenant shall obtain, maintain and pay for all permits and approvals needed for the operation of Tenant’s business, as soon as reasonably possible, and in any event shall not undertake any operations or use of Tenant’s equipment unless all applicable permits and approvals are in place and shall, promptly take all actions necessary to comply with all Legal Requirements, including, without limitation, the Occupational Safety and Health Act, applicable to Tenant’s use of the Premises, the Property or

 

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the Building. Tenant shall maintain in full force and effect all certifications or permissions required by any authority having jurisdiction to authorize, franchise or regulate Tenant’s use of the Premises. Tenant shall be solely responsible for procuring and complying at all times with any and all necessary permits and approvals directly or indirectly relating or incident to: the conduct of its activities on the Premises; its scientific experimentation, transportation, storage, handling, use and disposal of any chemical or radioactive or bacteriological or pathological substances or organisms or other hazardous wastes or environmentally dangerous substances or materials or medical waste or animals or laboratory specimens. Within ten (10) days of a request by Landlord, which request shall be made not more than once during each period of twelve (12) consecutive months during the Term hereof, unless otherwise requested by any mortgagee of Landlord or unless Landlord reasonably suspects that Tenant has violated the provisions of this Section 19.1, Tenant shall furnish Landlord with copies of all such permits and approvals that Tenant possesses or has obtained together with a certificate certifying that such permits are all of the permits that Tenant possesses or has obtained with respect to the Premises. Tenant shall promptly give written notice to Landlord of any warnings or violations relative to the above received from any federal, state or municipal agency or by any court of law and shall promptly cure the conditions causing any such violations. Tenant shall not be deemed to be in default of its obligations under the preceding sentence to promptly cure any condition causing any such violation in the event that, in lieu of such cure, Tenant shall contest the validity of such violation by appellate or other proceedings permitted under applicable law, provided that: (i) any such contest is made reasonably and in good faith, (ii) Tenant makes provisions, including, without limitation, posting bond(s) or giving other security, reasonably acceptable to Landlord to protect Landlord, the Building and the Property from any liability, costs, damages or expenses arising in connection with such alleged violation and failure to cure, (iii) Tenant shall agree to indemnify, defend (with counsel reasonably acceptable to Landlord) and hold Landlord harmless from and against any and all liability, costs, damages, or expenses arising in connection with such condition and/or violation, (iv) Tenant shall promptly cure any violation in the event that its appeal of such violation is overruled or rejected, and (v) Tenant’s decision to delay such cure shall not, in Landlord’s good faith determination, be likely to result in any actual or threatened bodily injury, property damage, or any civil or criminal liability to Landlord, any tenant or occupant of the Building or the Property, or any other person or entity. Nothing contained in this Section 19.1 shall be construed to expand the uses permitted hereunder beyond the Permitted Uses. Landlord shall comply with any Legal Requirements and with any direction of any public office or officer relating to the maintenance or operation of the structural elements of the Building and the Common Areas, and the costs so incurred by Landlord shall be included in Operating Costs in accordance with the provisions of Section 5.2.

20.    DEFAULT

20.1    Events of Default. The occurrence of any one or more of the following events shall constitute an “Event of Default” hereunder by Tenant:

(a)    If Tenant fails to make any payment of Rent or any other payment required hereunder, as and when due, and such failure shall continue for a period of five (5) business days after notice thereof from Landlord to Tenant; provided, however, an Event of Default shall occur hereunder without any obligation of Landlord to give any notice if (i) Tenant fails to make any payment within five (5) business days after the due date therefor, and (ii) Landlord has given Tenant written notice under this Section 20.1(a) on more than two (2) occasions during the twelve (12) month interval preceding such failure by Tenant;

 

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(b)    Intentionally omitted;

(c)    If Tenant shall fail to execute and deliver to Landlord an estoppel certificate pursuant to Article 16 above or a subordination and attornment agreement pursuant to Article 22 below, within the timeframes set forth therein;

(d)    If Tenant shall fail to maintain any insurance required hereunder;

(e)    If Tenant shall fail to restore the Security Deposit to its original amount or deliver a replacement Letter of Credit as required under Article 7 above;

(f)    If Tenant causes or suffers any release of Hazardous Materials in or near the Property;

(g)    If Tenant shall make a Transfer in violation of the provisions of Article 13 above, or if any event shall occur or any contingency shall arise whereby this Lease, or the Term and estate thereby created, would (by operation of law or otherwise) devolve upon or pass to any person, firm or corporation other than Tenant, except as expressly permitted under Article 13 hereof;

(h)    If Tenant shall fail to perform its obligations under Section 3 hereof and such failure continues for more than thirty (30) days after notice thereof from Landlord;

(i)    The failure by Tenant to observe or perform any of the covenants or provisions of this Lease to be observed or performed by Tenant, other than as specified above, and such failure continues for more than thirty (30) days after notice thereof from Landlord; provided, further, that if the nature of Tenant’s default is such that more than thirty (30) days are reasonably required for its cure, then Tenant shall not be deemed to be in default if Tenant shall commence such cure within said thirty (30) day period and thereafter diligently prosecute such cure to completion, which completion shall occur not later than ninety (90) days from the date of such notice from Landlord;

(j)    Tenant shall be involved in financial difficulties as evidenced by an admission in writing by Tenant of Tenant’s inability to pay its debts generally as they become due, or by the making or offering to make a composition of its debts with its creditors;

(k)    Tenant shall make an assignment or trust mortgage, or other conveyance or transfer of like nature, of all or a substantial part of its property for the benefit of its creditors,

(l)    an attachment on mesne process, on execution or otherwise, or other legal process shall issue against Tenant or its property and a sale of any of its assets shall be held thereunder;

(m)    the leasehold hereby created shall be taken on execution or by other process of law and shall not be revested in Tenant within thirty (30) days thereafter;

 

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(n)    a receiver, sequesterer, trustee or similar officer shall be appointed by a court of competent jurisdiction to take charge of all or any part of Tenant’s Property and such appointment shall not be vacated within thirty (30) days; or

(o)    any proceeding shall be instituted by or against Tenant pursuant to any of the provisions of any Act of Congress or State law relating to bankruptcy, reorganizations, arrangements, compositions or other relief from creditors, and, in the case of any proceeding instituted against it, if Tenant shall fail to have such proceedings dismissed within thirty (30) days or if Tenant is adjudged bankrupt or insolvent as a result of any such proceeding; or With respect to the defaults set forth in subsections (c), (d), (e), and (g) above, if Tenant shall fail to cure the default within the respective required timeframes set forth in this Lease, and such failure shall continue for three (3) business days after Tenant’s receipt of a Reminder Notice (as defined below), then such events shall be deemed to be an Event of Default. For purposes hereof, a “Reminder Notice” shall be a notice from Landlord to Tenant that states in bold faced capital letters at the top of the first page thereof the following: “TENANT’S FAILURE TO CURE DEFAULT WITHIN THREE (3) BUSINESS DAYS AFTER RECEIPT OF THIS NOTICE SHALL CONSTITUTE AN EVENT OF DEFAULT.”

20.2    Remedies. Upon an Event of Default, Landlord may, by notice to Tenant, elect to terminate this Lease; and thereupon (and without prejudice to any remedies which might otherwise be available for arrears of Rent or preceding breach of covenant or agreement and without prejudice to Tenant’s liability for damages as hereinafter stated), upon the giving of such notice, this Lease shall terminate as of the date specified therein as though that were the Expiration Date. Upon such termination, Landlord shall have the right to utilize the Security Deposit or draw down the entire Letter of Credit, as applicable, and apply the proceeds thereof to its damages hereunder. Without being taken or deemed to be guilty of any manner of trespass or conversion, and without being liable to indictment, prosecution or damages therefor, Landlord may, by lawful process, enter into and upon the Premises (or any part thereof in the name of the whole); repossess the same, as of its former estate; and expel Tenant and those claiming under Tenant. The words “re-entry” and “re-enter” as used in this Lease are not restricted to their technical legal meanings.

20.3    Damages - Termination.

(a)    Upon the termination of this Lease under the provisions of this Article 20, Tenant shall pay to Landlord Rent up to the time of such termination, shall continue to be liable for any preceding breach of covenant, and in addition, shall pay to Landlord as damages, at the election of Landlord, either:

(i)    the amount (discounted to present value at the rate of five percent (5%) per annum) by which, at the time of the termination of this Lease (or at any time thereafter if Landlord shall have initially elected damages under Section 20.3(a)(ii) below), (x) the aggregate of Rent projected over the period commencing with such termination and ending on the Expiration Date, exceeds (y) the aggregate projected rental value of the Premises for such period, taking into account a reasonable time period during which the Premises shall be unoccupied, plus all Reletting Costs (hereinafter defined); or

 

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(ii)    amounts equal to Rent which would have been payable by Tenant had this Lease not been so terminated, payable upon the due dates therefor specified herein following such termination and until the Expiration Date, provided, however, if Landlord shall re-let the Premises during such period, that Landlord shall credit Tenant with the net rents received by Landlord from such re-letting, such net rents to be determined by first deducting from the gross rents as and when received by Landlord from such re-letting the expenses incurred or paid by Landlord in terminating this Lease, as well as the expenses of re-letting, including altering and preparing the Premises for new tenants, brokers’ commissions, and all other similar and dissimilar expenses properly chargeable against the Premises and the rental therefrom (collectively, “Reletting Costs”), it being understood that any such re-letting may be for a period equal to or shorter or longer than the remaining Term; and provided, further, that (x) in no event shall Tenant be entitled to receive any excess of such net rents over the sums payable by Tenant to Landlord hereunder and (y) in no event shall Tenant be entitled in any suit for the collection of damages pursuant to this Section 20.3(a)(ii) to a credit in respect of any net rents from a re-letting except to the extent that such net rents are actually received by Landlord prior to the commencement of such suit. If the Premises or any part thereof should be re-let in combination with other space, then proper apportionment on a square foot area basis shall be made of the rent received from such re-letting and of the expenses of re-letting.

(b)    In calculating the amount due under Section 20.3(a)(i), above, there shall be included, in addition to the Base Rent, all other considerations agreed to be paid or performed by Tenant, including without limitation Tenant’s Share of Operating Costs and Taxes, on the assumption that all such amounts and considerations would have increased at the rate of three percent (3%) per annum for the balance of the full Term hereby granted.

(c)    Suit or suits for the recovery of such damages, or any installments thereof, may be brought by Landlord from time to time at its election, and nothing contained herein shall be deemed to require Landlord to postpone suit until the date when the Term would have expired if it had not been terminated hereunder.

(d)    Nothing herein contained shall be construed as limiting or precluding the recovery by Landlord against Tenant of any sums or damages to which, in addition to the damages particularly provided above, Landlord may lawfully be entitled by reason of any Event of Default hereunder.

20.4    Landlord’s Self-Help; Fees and Expenses. If Tenant shall default in the performance of any covenant on Tenant’s part to be performed in this Lease contained, including without limitation the obligation to maintain the Premises in the required condition pursuant to Section 10.1 above, Landlord may, upon reasonable advance notice, except that no notice shall be required in an emergency, immediately, or at any time thereafter, perform the same for the account of Tenant. Tenant shall pay to Landlord within thirty (30) days of Landlord’s written demand therefor any costs incurred by Landlord in connection therewith, together with interest at the Default Rate until paid in full. In addition, Tenant shall pay all of Landlord’s costs and expenses, including without limitation reasonable attorneys’ fees, incurred (i) in enforcing any obligation of Tenant under this Lease or (ii) as a result of Landlord or any of the Landlord Parties, without its fault, being made party to any litigation pending by or against any of the Tenant Parties.

 

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20.5    Waiver of Redemption, Statutory Notice and Grace Periods. Tenant does hereby waive and surrender all rights and privileges which it might have under or by reason of any present or future Legal Requirements to redeem the Premises or to have a continuance of this Lease for the Term hereby demised after being dispossessed or ejected therefrom by process of law or under the terms of this Lease or after the termination of this Lease as herein provided. Except to the extent prohibited by Legal Requirements, any statutory notice and grace periods provided to Tenant by law are hereby expressly waived by Tenant.

20.6    Landlord’s Remedies Not Exclusive. The specified remedies to which Landlord may resort hereunder are cumulative and are not intended to be exclusive of any remedies or means of redress to which Landlord may at any time be lawfully entitled, and Landlord may invoke any remedy (including the remedy of specific performance) allowed at law or in equity as if specific remedies were not herein provided for.

20.7    No Waiver. Landlord’s failure to seek redress for violation, or to insist upon the strict performance, of any covenant or condition of this Lease, or any of the Rules and Regulations promulgated hereunder, shall not prevent a subsequent act, which would have originally constituted a violation, from having all the force and effect of an original violation. The receipt by Landlord of Rent with knowledge of the breach of any covenant of this Lease shall not be deemed a waiver of such breach. The failure of Landlord to enforce any of such Rules and Regulations against Tenant and/or any other tenant in the Building shall not be deemed a waiver of any such Rules and Regulations. No provisions of this Lease shall be deemed to have been waived by either party unless such waiver be in writing signed by such party. No payment by Tenant or receipt by Landlord of a lesser amount than the Rent herein stipulated shall be deemed to be other than on account of the stipulated Rent, nor shall any endorsement or statement on any check or any letter accompanying any check or payment as Rent be deemed an accord and satisfaction, and Landlord may accept such check or payment without prejudice to Landlord’s right to recover the balance of such Rent or pursue any other remedy in this Lease provided.

20.8    Restrictions on Tenant’s Rights. During the continuation of any Event of Default, (a) Landlord shall not be obligated to provide Tenant with any notice pursuant to Sections 2.3 and 2.4 above; and (b) Tenant shall not have the right to make, nor to request Landlord’s consent or approval with respect to, any Alterations or Transfers.

20.9    Landlord Default. Notwithstanding anything to the contrary contained in the Lease, Landlord shall in no event be in default in the performance of any of Landlord’s obligations under this Lease unless Landlord shall have failed to perform such obligations within thirty (30) days (or such additional time as is reasonably required to correct any such default, provided Landlord commences cure within 30 days) after notice by Tenant to Landlord properly specifying wherein Landlord has failed to perform any such obligation. Except as expressly set forth in this Lease, Tenant shall not have the right to terminate or cancel this Lease or to withhold rent or to set-off or deduct any claim or damages against rent as a result of any default by Landlord or breach by Landlord of its covenants or any warranties or promises hereunder, except in the case of a wrongful eviction of Tenant from the Premises (constructive or actual) by Landlord, and then only if the same continues after notice to Landlord thereof and an opportunity for Landlord to cure the same as set forth above. In addition, Tenant shall not assert any right to deduct the cost of repairs or any monetary claim against Landlord from rent thereafter due and payable under this Lease.

 

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21.    SURRENDER; ABANDONED PROPERTY; HOLD-OVER

21.1    Surrender

(a)    Upon the expiration or earlier termination of the Term, Tenant shall (i) peaceably quit and surrender to Landlord the Premises (including without limitation all fixed lab benches, fume hoods, electric, plumbing, heating and sprinkling systems, vaults, paneling, molding, shelving, radiator enclosures, cork, rubber, linoleum and composition floors, ventilating, silencing, air conditioning and cooling equipment therein and all other furniture, fixtures, and equipment that was either provided by Landlord or paid for in whole or in part by any allowance provided to Tenant by Landlord under this Lease) broom clean, in good order, repair and condition excepting only ordinary wear and tear and damage by fire or other insured Casualty; (ii) remove all of Tenant’s Property (including furniture, fixtures, and equipment installed by Tenant, at Tenant’s sole cost and expense and not otherwise listed in clause (i) above), all autoclaves and cage washers and, to the extent specified by Landlord, Alterations made by Tenant; and (iii) repair any damages to the Premises or the Building caused by the installation or removal of Tenant’s Property and/or such Alterations. Tenant’s obligations under this Section 21.1(a) shall survive the expiration or earlier termination of this Lease.

(b)    Prior to the expiration of this Lease (or within thirty (30) days after any earlier termination), Tenant shall clean and otherwise decommission all interior surfaces (including floors, walls, ceilings, and counters), piping, supply lines, waste lines, acid neutralization systems and plumbing in and/or exclusively serving the Premises, and all exhaust or other ductwork in and/or exclusively serving the Premises, in each case which has carried or released or been contacted by any Hazardous Materials or other chemical or biological materials used in the operation of the Premises, and shall otherwise clean the Premises so as to permit the Surrender Plan (defined below) to be issued. At least thirty (30) days prior to the expiration of the Term (or, if applicable, within five (5) business days after any earlier termination of this Lease), Tenant shall deliver to Landlord a reasonably detailed narrative description of the actions proposed (or required by any Legal Requirements) to be taken by Tenant in order to render the Premises (including any Alterations permitted or required by Landlord to remain therein) free of Hazardous Materials and otherwise released for unrestricted use and occupancy including without limitation causing the Premises to be decommissioned in accordance with the regulations of the U.S. Nuclear Regulatory Commission and/or the Massachusetts Department of Public health (the “MDPH”) for the control of radiation, and cause the Premises to be released for unrestricted use by the Radiation Control Program of the MDPH (the “Surrender Plan”). The Surrender Plan (i) shall be accompanied by a current list of (A) all Required Permits held by or on behalf of any Tenant Party with respect to Hazardous Materials in, on, under, at or about the Premises, and (B) Tenant’s Hazardous Materials, and (ii) shall be subject to the review and approval of Landlord’s environmental consultant. In connection with review and approval of the Surrender Plan, upon request of Landlord, Tenant shall deliver to Landlord or its consultant such additional non-proprietary information concerning the use of and operations within the Premises as Landlord shall request. On or before the expiration of the Term (or within thirty (30) days after any earlier termination of this Lease, during which period Tenant’s use and occupancy of the Premises shall be governed by Section 21.3 below), Tenant shall (i) perform or cause to be performed all actions described in the approved Surrender Plan, and (ii) deliver to Landlord a certification from a third party certified industrial hygienist reasonably acceptable to Landlord certifying that the Premises

 

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do not contain any Hazardous Materials and evidence that the approved Surrender Plan shall have been satisfactorily completed by a contractor acceptable to Landlord, and Landlord shall have the right, subject to reimbursement at Tenant’s expense as set forth below, to cause Landlord’s environmental consultant to inspect the Premises and perform such additional procedures as may be deemed reasonably necessary to confirm that the Premises are, as of the expiration of the Term (or, if applicable, the date which is thirty (30) days after any earlier termination of this Lease), free of Hazardous Materials and otherwise available for unrestricted use and occupancy as aforesaid. Landlord shall have the unrestricted right to deliver the Surrender Plan and any report by Landlord’s environmental consultant with respect to the surrender of the Premises to third parties. Such third parties and the Landlord Parties shall be entitled to rely on the Surrender Report. If Tenant shall fail to prepare or submit a Surrender Plan approved by Landlord, or if Tenant shall fail to complete the approved Surrender Plan, or if such Surrender Plan, whether or not approved by Landlord, shall fail to adequately address the use of Hazardous Materials by any of the Tenant Parties in, on, at, under or about the Premises, Landlord shall have the right to take any such actions as Landlord may deem reasonable or appropriate to assure that the Premises and the Property are surrendered in the condition required hereunder, the cost of which actions shall be reimbursed by Tenant as additional rent within thirty (30) days of Landlord’s written demand therefor. Tenant’s obligations under this Section 21.1(b) shall survive the expiration or earlier termination of the Term.

(c)    No act or thing done by Landlord during the Term shall be deemed an acceptance of a surrender of the Premises, and no agreement to accept such surrender shall be valid, unless in writing signed by Landlord. Unless otherwise agreed by the parties in writing, no employee of Landlord or of Landlord’s agents shall have any power to accept the keys of the Premises prior to the expiration or earlier termination of this Lease. The delivery of keys to any employee of Landlord or of Landlord’s agents shall not operate as a termination of this Lease or a surrender of the Premises.

(d)    Notwithstanding anything to the contrary contained herein, Tenant shall, at its sole cost and expense, remove from the Premises, prior to the end of the Term, any item installed by or for Tenant and which, pursuant to Legal Requirements, must be removed therefrom before the Premises may be used by a subsequent tenant.

21.2    Abandoned Property. After the expiration or earlier termination hereof, if Tenant fails to remove any property from the Building or the Premises which Tenant is obligated by the terms of this Lease to remove within five (5) business days after written notice from Landlord, such property (the “Abandoned Property”) shall be conclusively deemed to have been abandoned, and may either be retained by Landlord as its property or sold or otherwise disposed of in such manner as Landlord may see fit. If any item of Abandoned Property shall be sold, Tenant hereby agrees that Landlord may receive and retain the proceeds of such sale and apply the same, at its option, to the expenses of the sale, the cost of moving and storage, any damages to which Landlord may be entitled under Article 20 hereof or pursuant to law, and to any arrears of Rent.

 

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21.3    Holdover. If any of the Tenant Parties holds over (which term shall include, without limitation, the failure of Tenant or any Tenant Party to perform all of its obligations under Section 21.1 above) after the end of the Term, Tenant shall be deemed a tenant-at-sufferance subject to the provisions of this Lease. Whether or not Landlord has previously accepted payments of Rent from Tenant:

(i)    Tenant shall pay Base Rent at the Hold Over Percentage, as hereinafter defined, of the highest rate of Base Rent payable during the Term,

(ii)    Tenant shall continue to pay to Landlord all Additional Rent, and

(iii)    in the event such hold over extends beyond sixty (60) days after the end of the Term, Tenant shall be liable for all damages, including without limitation lost business and consequential damages, incurred by Landlord as a result of such holding over, Tenant hereby acknowledging that Landlord may need the Premises after the end of the Term for other tenants and that the damages which Landlord may suffer as the result of Tenant’s holding over cannot be determined as of the Execution Date. Nothing contained herein shall grant Tenant the right to holdover after the expiration or earlier termination of the Term. The “Hold Over Percentage” shall be 150% for the first sixty (60) days of such holdover, and 200% for any period of hold over after the first sixty (60) days. Nothing contained herein shall grant Tenant the right to holdover after the expiration or earlier termination of the Term.

21.4    Warranties. Tenant hereby assigns to Landlord any warranties in effect on the last day of the Term with respect to any fixtures and Alterations installed in the Premises. Tenant shall provide Landlord with copies of any such warranties prior to the expiration of the Term (or, if the Lease is earlier terminated, within five (5) days thereafter).

22.    MORTGAGEE RIGHTS

22.1    Subordination. Tenant’s rights and interests under this Lease shall be (i) subject and subordinate to any ground lease, overleases, mortgage, deed of trust, or similar instrument covering the Premises, the Building and/or the Land and to all advances, modifications, renewals, replacements, and extensions thereof (each of the foregoing, a “Mortgage”), or (ii) if any Mortgagee elects, prior to the lien of any present or future Mortgage. Tenant further shall attorn to and recognize any successor landlord, whether through foreclosure or otherwise, as if the successor landlord were the originally named landlord. The provisions of this Section 22.1 shall be self-operative and no further instrument shall be required to effect such subordination or attornment; however, Tenant agrees to execute, acknowledge and deliver such instruments, confirming such subordination and attornment in such form as shall be requested by any such holder within fifteen (15) days of request therefor. Landlord agrees to use reasonable efforts to obtain an SNDA, as hereinafter defined, from the holder of any future mortgage which affects the Property. An “SNDA” shall be defined as a subordination, non-disturbance and attornment agreement on the standard form of SNDA then being used by the holder of the Mortgage in question, with such commercially reasonable modification as may be requested by Tenant.

22.2    Notices. Tenant shall give each Mortgagee the same notices given to Landlord concurrently with the notice to Landlord, and each Mortgagee shall have a reasonable opportunity thereafter to cure a Landlord default, and Mortgagee’s curing of any of Landlord’s default shall be treated as performance by Landlord.

 

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22.3    Mortgagee Consent. Tenant acknowledges that, where applicable, any consent or approval hereafter given by Landlord may be subject to the further consent or approval of a Mortgagee; and the failure or refusal of such Mortgagee to give such consent or approval shall, notwithstanding anything to the contrary in this Lease contained, constitute reasonable justification for Landlord’s withholding its consent or approval.

22.4    Mortgagee Liability. Tenant acknowledges and agrees that if any Mortgage shall be foreclosed, (a) the liability of the Mortgagee and its successors and assigns shall exist only so long as such Mortgagee or purchaser is the owner of the Premises, and such liability shall not continue or survive after further transfer of ownership; and (b) subject to the last sentence of this Section 22.4, such Mortgagee and its successors or assigns shall not be (i) liable for any act or omission of any prior lessor under this Lease; (ii) liable for the performance of Landlord’s covenants pursuant to the provisions of this Lease which arise and accrue prior to such entity succeeding to the interest of Landlord under this Lease or acquiring such right to possession; (iii) subject to any offsets or defense which Tenant may have at any time against Landlord; (iv) bound by any base rent or other sum which Tenant may have paid previously for more than one (1) month; or (v) liable for the performance of any covenant of Landlord under this Lease which is capable of performance only by the original Landlord. Notwithstanding the foregoing: (x) nothing shall relieve any Mortgagee, purchaser at foreclosure, or grantee of a deed in lieu of foreclosure from: (i) any liability which it has as Landlord under the Lease from and after the date (the “Succession Date”) which it succeeds to Landlord’s interest under the Lease, and (y) any obligation which Landlord has to perform repairs or maintenance under the Lease based upon the fact that the need for such repairs or maintenance first arose after the Succession Date.

23.    QUIET ENJOYMENT.

Landlord covenants that so long as Tenant keeps and performs each and every covenant, agreement, term, provision and condition herein contained on the part and on behalf of Tenant to be kept and performed, Tenant shall peaceably and quietly hold, occupy and enjoy the Premises during the Term from and against the claims of all persons lawfully claiming by, through or under Landlord subject, nevertheless, to the covenants, agreements, terms, provisions and conditions of this Lease, any matters of record or of which Tenant has knowledge and to any Mortgage to which this Lease is subject and subordinate, as hereinabove set forth.

24.    NOTICES.

Any notice, consent, request, bill, demand or statement hereunder (each, a “Notice”) by either party to the other party shall be in writing and shall be deemed to have been duly given when either delivered by hand or by nationally recognized overnight courier (in either case with evidence of delivery or refusal thereof) addressed as follows:

 

  If to Landlord:

PPF OFF 828-830 Winter Street LLC

c/o King Street Properties

800 Boylston Street, Suite 1570

Boston, MA 02199

Attention: Stephen D. Lynch

 

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  With a copy to:

Morgan Stanley

1585 Broadway, 37th Floor

New York, NY 10036

Attention: Jennie P. Friend

Email: Jennie.Friend@morganstanley.com

 

  With a copy to:

Goulston & Storrs PC

400 Atlantic Avenue

Boston, MA 02110

Attention: King Street

 

  if to Tenant:

Q32 Bio Inc.

One Broadway

14th Floor

Cambridge, MA 02142

 

  With a copy to:

Goodwin Procter LLP

100 Northern Avenue

Boston, MA 02210

Attn: Nicole Riley, Esq.

Notwithstanding the foregoing, any notice from Landlord to Tenant regarding ordinary business operations (e.g., exercise of a right of access to the Premises, maintenance activities, invoices, etc.) may also be given by written notice delivered by email to those parties listed in Section 2.4. Either party may at any time change the address or specify an additional address for such Notices by delivering or mailing, as aforesaid, to the other party a notice stating the change and setting forth the changed or additional address, provided such changed or additional address is within the United States. Notices shall be effective upon the date of receipt or refusal thereof.

25.    CONDOMINIUM CONVERSION

The Premises are located in the Building which is erected on the Land which comprises the Property owned by Landlord. The Property may be further enlarged and/or improved with additional buildings (provided that no such enlargements or improvements shall have a material adverse impact on Tenant’s rights under this Lease).

Landlord, on behalf of itself and its successors and assigns, reserves the right to convert the Property, and all of the buildings now or hereafter located thereon, to the condominium form of ownership pursuant to Massachusetts General Laws Chapter 183A (the “Condominium”), so long as such Condominium does not: not: (x) adversely affect Tenant’s rights under this Lease, or (y) increase Tenant’s obligations under this Lease.

In the event of the conversion of the Property to the Condominium, Tenant will reasonably cooperate in the negotiation and execution of commercially reasonable documentation which confirms that the Premises will be described in the Master Deed of the Condominium (the “Master Deed”) as part or all of a unit in the Condominium (the “Unit”) and shall be subject to said Master Deed and also to an agreement which governs the rights and obligations of the owners of such units (the “Declaration of Trust”) (the Master Deed, the Declaration of Trust and any

 

55


bylaws and rules or regulations promulgated thereunder are referred to collectively as the “Condominium Documents”). Landlord and its successors and assigns shall be subject to the Condominium Documents.

Tenant agrees that in connection with the creation of the Condominium, Tenant will reasonably cooperate in the negotiation and execution of commercially reasonable documentation which confirms that this Lease shall be subject and subordinate to the Condominium Documents and that Tenant’s leasehold interest will be converted to a leasehold interest in all or a demised portion of an individual unit in the Condominium and an interest in common with others to use common areas of the Condominium that are ancillary to Tenant’s Premises under this Lease.

26.    MISCELLANEOUS

26.1    Separability. If any provision of this Lease or portion of such provision or the application thereof to any person or circumstance is for any reason held invalid or unenforceable, the remainder of this Lease (or the remainder of such provision) and the application thereof to other persons or circumstances shall not be affected thereby.

26.2    Captions. The captions are inserted only as a matter of convenience and for reference, and in no way define, limit or describe the scope of this Lease nor the intent of any provisions thereof.

26.3    Broker. Tenant and Landlord each warrants and represents that it has dealt with no broker in connection with the consummation of this Lease other than CBRE (Landlord) and JLL (Tenant) (collectively, the “Brokers”). Tenant and Landlord each agrees to defend, indemnify and save the other harmless from and against any Claims arising in breach of the representation and warranty set forth in the immediately preceding sentence. Landlord shall be solely responsible for the payment of any brokerage commissions to the Brokers.

26.4    Entire Agreement. This Lease, Lease Summary Sheet and Exhibits 1 through 111 attached hereto and incorporated herein contain the entire and only agreement between the parties and any and all statements and representations, written and oral, including previous correspondence and agreements between the parties hereto, are merged herein. Tenant acknowledges that all representations and statements upon which it relied in executing this Lease are contained herein and that Tenant in no way relied upon any other statements or representations, written or oral. This Lease may not be modified orally or in any manner other than by written agreement signed by the parties hereto.

26.5    Governing Law. This Lease is made pursuant to, and shall be governed by, and construed in accordance with, the laws of the Commonwealth of Massachusetts and any applicable local municipal rules, regulations, by-laws, ordinances and the like.

26.6    Representation of Authority. By his or her execution hereof, each of the signatories on behalf of the respective parties hereby warrants and represents to the other that he or she is duly authorized to execute this Lease on behalf of such party. Upon Landlord’s request, Tenant shall provide Landlord with evidence that any requisite resolution, corporate authority and any other necessary consents have been duly adopted and obtained.

 

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26.7    Expenses Incurred by Landlord Upon Tenant Requests.

(a)    Tenant shall, upon demand, reimburse Landlord for all reasonable expenses, including, without limitation, legal fees, incurred by Landlord in connection with all requests by Tenant for consents, approvals or execution of collateral documentation related to this Lease, including, without limitation, costs incurred by Landlord in the review and approval of Tenant’s plans and specifications in connection with proposed Alterations to be made by Tenant to the Premises or in connection with requests by Tenant for Landlord’s consent to make a Transfer. Such costs shall be deemed to be additional rent under this Lease.

(b)    Notwithstanding the foregoing: (i) the amount of legal fees which Tenant is required to reimburse Landlord with respect to any Transfer shall not exceed the Transfer Legal Fee Cap, as hereinafter defined, with respect to such Transfer, and (ii) with respect any request by Tenant to review and approve Tenant’s plans and specifications with respect to any Alteration, Tenant shall only be required to reimburse Landlord for third party consultants engaged by Landlord to review such plans and specifications as Landlord, in good faith determines is necessary (e.g., reviews by structure engineers, MEP engineers, etc.). The “Transfer Legal Fees Cap” shall be defined as $2,500, except that (x) the Transfer Legal Fees Cap shall increase by $500 every fifth (5th) anniversary of the Term Commencement Date, and (y) the Transfer Legal Fees Cap shall not apply to Tenant’s request for Landlord’s approval of any sub-sublease of any tier.

26.8    Survival. Without limiting any other obligation of Tenant which may survive the expiration or prior termination of the Term, all obligations on the part of Tenant to indemnify, defend, or hold Landlord harmless, as set forth in this Lease shall survive the expiration or prior termination of the Term.

26.9    Limitation of Liability.

(a)    Limitation of Landlord’s Liability. Tenant shall neither assert nor seek to enforce any claim against Landlord or any of the Landlord Parties, or the assets of any of the Landlord Parties, for breach of this Lease or otherwise, other than against Landlord’s interest in the Building and in the uncollected rents, issues and profits thereof, and Tenant agrees to look solely to such interest for the satisfaction of any liability of Landlord under this Lease. This Section 26.9 shall not limit any right that Tenant might otherwise have to obtain injunctive relief against Landlord. Landlord and Tenant specifically agree that in no event shall any officer, director, trustee, employee or representative of Landlord or any of the other Landlord Parties ever be personally liable for any obligation under this Lease, nor shall Landlord or any of the other Landlord Parties be liable for consequential or incidental damages or for lost profits whatsoever in connection with this Lease.

(b)    Limitation of Tenant’s Liability. Landlord shall neither assert nor seek to enforce any claim against Tenant or any of the Tenant Parties for breach of this Lease or otherwise, other than against the assets and property of Tenant, and Landlord agrees to look solely to such assets and property for the satisfaction of any liability of Tenant or any Tenant Parties under this Lease. This Section 26.9(b) shall not limit any right that Landlord might otherwise have to obtain injunctive relief against Tenant. Landlord and Tenant specifically agree that in no event: (i) any officer, director, trustee, employee or representative of Tenant or any of the other Tenant Parties

 

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ever be personally liable for any obligation under this Lease, and (ii) Tenant or any of the other Tenant Parties be liable for consequential or incidental damages or for lost profits whatsoever in connection with this Lease, except that nothing in this Section 26.9(b) shall limit or affect any liability or obligation which Tenant may have in the event of any breach by Tenant of its obligations under either Article 17 (Hazardous Materials) or Section 21.3 (Holdover).

26.10    Binding Effect. The covenants, agreements, terms, provisions and conditions of this Lease shall bind and benefit the successors and assigns of the parties hereto with the same effect as if mentioned in each instance where a party hereto is named or referred to, except that no violation of the provisions of Article 13 hereof shall operate to vest any rights in any successor or assignee of Tenant. A facsimile or electronic signature on this Lease shall be equivalent to, and have the same force and effect as, an original signature.

26.11    Landlord Obligations upon Transfer. Upon any sale, transfer or other disposition of the Building, Landlord shall be entirely freed and relieved from the performance and observance thereafter of all covenants and obligations hereunder on the part of Landlord to be performed and observed, it being understood and agreed in such event (and it shall be deemed and construed as a covenant running with the land) that the person succeeding to Landlord’s ownership of said reversionary interest shall thereupon and thereafter assume, and perform and observe, any and all of such covenants and obligations of Landlord, except as otherwise agreed in writing.

26.12    No Grant of Interest. Tenant shall not grant any interest whatsoever in any fixtures within the Premises or any item paid in whole or in part by Landlord, including without limitation by Landlord’s Contribution.

26.13    Financial Information. Tenant shall deliver to Landlord, within thirty (30) days after Landlord’s reasonable request (which request may be made no more than one time every twelve (12) months provided that such limitation shall not apply in the event of a sale or financing of any of Landlord’s interest in the Lease or the Premises), Tenant’s most recently completed balance sheet and related statements of income, shareholder’s equity and cash flows statements (audited if available) reviewed by an independent certified public accountant (if available) and certified by an officer of Tenant as being true and correct in all material respects. Any such financial information may be relied upon by any actual or potential lessor, purchaser, or mortgagee of the Property or any portion thereof.

26.14    OFAC Certificate and Indemnity. As an inducement to Landlord to enter into this Lease, Tenant hereby represents and warrants that: (i) Tenant is not, nor is it owned or controlled directly or to Tenant’s knowledge, indirectly by, any person, group, entity or nation named on any list issued by the Office of Foreign Assets Control of the United States Department of the Treasury pursuant to Executive Order No. 13224 or any similar list or any law, order, rule or regulation or any Executive Order of the President of the United States as a terrorist, “Specially Designated National and Blocked Person” or other banned or blocked person (any such person, group, entity or nation being hereinafter referred to as a “Prohibited Person”); (ii) Tenant is not (nor is it owned, controlled, directly or to Tenant’s knowledge, indirectly, by any person, group, entity or nation which is) acting directly or to Tenant’s knowledge, indirectly for or on behalf of any Prohibited Person; and (iii) neither Tenant (nor any person, group, entity or nation which owns or controls Tenant, directly or to Tenant’s knowledge, indirectly) has conducted or will conduct

 

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business or has engaged or will engage in any transaction or dealing with any Prohibited Person, including without limitation any assignment of this Lease or any subletting of all or any portion of the Premises or the making or receiving of any contribution or funds, goods or services to or for the benefit of a Prohibited Person. In connection with the foregoing, it is expressly understood and agreed that (x) any breach by Tenant of the foregoing representations and warranties shall be an Event of Default, and (y) the representations, warranties and covenants contained in this Section 26.14 shall be continuing in nature and shall survive the expiration or earlier termination of this Lease.

26.15    Confidentiality. Tenant acknowledges and agrees that the terms of this Lease are confidential. Disclosure of the terms hereof could adversely affect the ability of Landlord to negotiate other leases with respect to the Building and may impair Landlord’s relationship with other tenants of the Building. Tenant agrees that it and its partners, officers, directors, employees, brokers, and attorneys, if any, shall not disclose the terms and conditions of this Lease (“Landlord Confidential Information”) to any other person or entity without the prior written consent of Landlord which may be given or withheld by Landlord, in Landlord’s sole discretion, except as required for financial disclosures or securities filings, as required by the order of any court or public body with authority over Tenant, or in connection with any litigation between Landlord and Tenant with respect to this Lease or to Tenant’s partners, officers, directors, employees, brokers, attorneys, or as may be required as part of any financing or Tenant’s normal course of business, provided that any recipient from Tenant of Landlord Confidential Information is required by Tenant to keep Landlord’s Confidential Information confidential in accordance with the terms of this Section 26.15. It is understood and agreed that damages alone would be an inadequate remedy for the breach of this provision by Tenant, and Landlord shall also have the right to seek specific performance of this provision and to seek injunctive relief to prevent its breach or continued breach.

26.16    Force Majeure. Other than for Tenant’s obligations under this Lease that can be performed by the payment of money (e.g., payment of Rent and maintenance of insurance), whenever a period of time is herein prescribed for action to be taken by either party hereto, such party shall not be liable or responsible for, and there shall be excluded from the computation of any such period of time, any delays due to strikes, riots, acts of God, shortages of labor or materials, war, acts of terrorism, governmental laws, regulations, or restrictions, national or regional emergency, or a pandemic, epidemic or other public health emergency or exigency, or any other causes of any kind whatsoever which are beyond the control of such party (collectively “Force Majeure”). In no event shall financial inability of a party be deemed to be Force Majeure. Without limiting the generality of the foregoing, Landlord and Tenant hereby acknowledge and agree that an event of Force Majeure exists as of the date of execution of this Amendment as a result of the COVID-19 pandemic, including, without limitation, federal, state and local declared states of emergency and government mandated closures of businesses, construction activities, quarantines and travel bans, and supply chain disruptions, and the like. In no event shall the existence and/or continuance of the COVID-19 pandemic or any resulting events of Force Majeure, including, without limitation, any declared states of emergency and/or government mandated closures of businesses in any way affect, reduce, abate, extend, delay, excuse, limit or detract from the obligations and liabilities of Tenant to pay the Rent and other charges payable under the Lease. All such Rent and other charges shall be due and payable in accordance with the terms and conditions of the Lease notwithstanding the occurrence or continuance of the COVID-19 pandemic or any resulting events of Force Majeure.

 

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IN WITNESS WHEREOF the parties hereto have executed this Lease as of the Execution Date.

LANDLORD:

 

PPF OFF 828-830 WINTER STREET, LLC,
a Delaware limited liability company
By:   PPF MASS REIT, LLC, a Delaware
  limited liability company, its Sole Member
  By:   PPF OP, LP, a Delaware limited
    partnership, its Sole Partner
    By:   PPF OPGP, LLC, a Delaware
      limited liability company, its
      General Partner
      By:   Prime Property Fund, LLC,
        a Delaware limited liability company,
        its Sole Member
        By:   Morgan Stanley Real Estate
          Advisor, Inc., a Delaware
          corporation, its Investment Adviser
          By:  

     

           

Name:

           

Title:

TENANT:

 

Q32 BIO INC.,  
a Delaware corporation  

By:

 

Name:

 

Title:

 

 

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Exhibit 10.48

NOTE PURCHASE AGREEMENT

THIS NOTE PURCHASE AGREEMENT (this “Agreement”), is made as of May 20, 2022 (the “Effective Date”), by and among Q32 BIO INC., a Delaware corporation (the “Company”), and each of the purchasers named on the Schedule of Purchasers attached hereto as Schedule I (the “Schedule of Purchasers”) (each individually a “Purchaser,” and collectively the “Purchasers”).

WHEREAS, the Company requires additional funds in order to fund its operations; and

WHEREAS, the Company desires to issue and sell the Notes (as defined herein) to the Purchasers, and the Purchasers desire to purchase the Notes from the Company.

NOW, THEREFORE, THE PARTIES HEREBY AGREE AS FOLLOWS:

1. DEFINITIONS.

1.1 “BMS” means Bristol-Myers Squibb Company.

1.2 “Board of Directors” shall mean the Company’s Board of Directors.

1.3 “Business Day” shall mean and include any day other than Saturdays, Sundays, or other days on which commercial banks in Boston, Massachusetts are required or authorized to be closed.

1.4 “Notes” shall mean the unsecured convertible promissory notes issued to the Purchasers pursuant to Section 2.1, in substantially the form attached hereto as Exhibit A.

1.5 “Operating Plan” shall mean the operating plan presented to the Board of Directors on May 9, 2022, as may be updated from time to time by the mutual agreement of management of the Company and the Board of Directors.

1.6 “Securities Act” shall mean the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.

2. NOTES; CLOSINGS.

2.1 Notes. The Company shall issue, and the Purchasers shall purchase, from time to time from the Company, Notes in an aggregate original principal amount not to exceed $30,000,003.00 (the “Aggregate Committed Note Amount”), pursuant to the terms and conditions hereof. The purchase price for the Notes shall be paid by the Purchasers by wire transfer of immediately available funds to a bank account designated by the Company. Each Purchaser’s obligations hereunder are several and not joint, and accordingly the failure of any Purchaser to purchase Notes hereunder will not increase the obligations of any other Purchaser.

2.2 Initial Closing. The initial closing (the “Initial Closing”) of the sale by the Company of Notes and the purchase by the Purchasers of Notes shall occur on the date hereof, at which time each Purchaser shall purchase a Note in the aggregate principal amount set forth opposite its name on the Schedule of Purchasers in the column titled “Initial Closing Notes ($)”. The Initial Closing shall be held remotely via the exchange of documents and signatures.


2.3 BMS Closing. After the Initial Closing, the Company may sell a Note, in the principal amount set forth on the Schedule of Purchasers in the column titled BMS Closing Note ($)”, to BMS, on a date and time mutually agreed between the Company and BMS (the “BMS Closing”), provided that such purchase and sale takes place within twenty-one (21) days of the Initial Closing. BMS shall deliver an executed counterpart signature page to this Agreement in connection with the BMS Closing, which will be held remotely via the exchange of documents and signatures.

2.4 Additional Closings. Following the Initial Closing, the Company may sell Notes, and the Purchasers may purchase Notes, at two additional closings of $10,000,000 aggregate principal amount of Notes at each such additional closing (each an “Additional Closing” and together, the “Additional Closings,” and together with the Initial Closing, the BMS Closing, and any Optional Closings (as defined below), the “Closings,” and each, a “Closing”) remotely via the exchange of documents and signatures on such dates occurring on or before December 31, 2022, as the Company, following approval by the Board of Directors to move forward with such Additional Closing, shall request in a written notice (the ‘‘Company Closing Notice”) to be delivered to the Purchasers at least ten (10) Business Days prior to the proposed date of the Additional Closing; provided that notwithstanding the foregoing, the Board of Directors may not elect to move forward with an Additional Closing until the Requisite Purchasers (as defined herein) have confirmed, in writing, that (i) the Company has not experienced a Material Adverse Effect (as defined herein) since the date of the last Closing and (ii) there has been no material deviation from the Operating Plan (the “Requisite Closing Notice”). The Additional Closing shall take place at the date and time specified in the Company Closing Notice. At each Additional Closing, each Purchaser shall purchase a Note, in the aggregate principal amount set forth opposite its name on the Schedule of Purchasers in the column titled “Additional Closing 1 Notes ($)” or “Additional Closing 2 Notes ($)”, as applicable, being issued to such Purchaser as such Additional Closing; provided that the aggregate principal amount of all of the Notes issued at the Initial Closing, any Additional Closings, the BMS Closing and any Optional Closings shall not exceed the Aggregate Committed Note Amount.

2.5 Transactions at Each Closing. At each Closing, the Company shall issue and the Purchasers shall purchase, on a several and not joint basis, the Notes as provided in this Section 2. At each Closing, the Company shall issue to each Purchaser, a Note representing the principal amount of the Note purchased by the Purchaser at such Closing.

2.6 Optional Closings. From time to time after the Initial Closing, subject to the terms and conditions of this Agreement, each Purchaser may elect (on its own behalf but not on behalf of any other Purchaser) to purchase, and, upon any such election, the Company shall sell, to the Purchaser a Note in the principal amount requested by the Purchaser, provided that all Notes issued to a Purchaser under this Agreement at all Closings may not exceed such Purchaser’s aggregate financing amount as set forth in the column titled “Total Note Investment ($)” on the Schedule of Purchasers (the occurrence of any such purchase and sale in accordance with the terms of this Section 2.6, an “Optional Closing”). Any Purchaser that elects to purchase a Note under this Section 2.6 (such Purchaser, a “Participating Purchaser”) shall give written notice to the Company of such election (an “Optional Closing Notice”), which notice shall specify (i) the principal amount of the Note that such Participating Purchaser elects to purchase at such Optional Closing and (ii) the date upon which such Participating Purchaser intends to purchase such Note, which date shall not be earlier than ten (10) Business Days after the delivery of such notice. Within two (2) Business Days of receipt of an Optional Closing Notice, the Company shall notify the other Purchasers of such Participating Purchaser’s election and the principal amount of the Note so elected to be purchased. In the event of any Optional Closings, the Company shall update the Schedule of Purchasers.

 

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2.7 Subordination. Purchasers acknowledge and agree that the obligations of the Company to make payment on the Notes are expressly subordinated in right of payment to all obligations of the Company to Silicon Valley Bank, a California corporation (the “Senior Lender”), pursuant to that certain Loan and Security Agreement between the Company and Senior Lender dated as of December 11, 2020, as the same may be amended from time to time, and is subject to that certain Subordination Agreement dated on or about the date hereof, by and among the Company, Senior Lender and Purchasers (as amended from time to time, the “Subordination Agreement”).

3. REPRESENTATIONS AND WARRANTIES OF THE COMPANY. In connection with the transactions provided for herein, the Company hereby represents and warrants to the Purchasers as of the date hereof, and as of the date of each applicable Closing:

3.1 Organization, Qualifications and Corporate Power. The Company is a corporation duly incorporated, validly existing and in good standing under the laws of the State of Delaware and is duly licensed or qualified to transact business as a foreign corporation and is in good standing in each jurisdiction in which the nature of the business transacted by it or the character of the properties owned or leased by it requires such licensing or qualification, except where the failure to be so licensed or qualified would not have a Material Adverse Effect (as defined below) on the business or assets of the Company. “Material Adverse Effect” shall mean any event, change, violation, inaccuracy, circumstance or effect that is, individually or in the aggregate, materially adverse to the financial condition, capitalization, properties, employees, assets (including intangible assets), business, operations or results of operations of the Company. The Company has the corporate power and authority to own and hold its properties and to carry on its business as now conducted, to execute, deliver and perform this Agreement and to issue, sell and deliver the Notes.

3.2 Authorization. The execution and delivery by the Company of this Agreement and the performance by the Company of its obligations hereunder and the issuance, sale and delivery of the Notes have been duly authorized by all requisite corporate action and will not violate any provision of law, any order of any court or other agency of government, the Company’s certificate of incorporation, as amended, or the Bylaws of the Company, as amended, or will not result in a violation of any provision of any indenture, agreement or other instrument to which the Company, or any of its properties or assets is bound, or conflict with, result in a material breach of or constitute (with due notice or lapse of time or both) a default under any such indenture, agreement or other instrument, or result in the creation or imposition of any lien, charge, restriction, encumbrance, or, to the Company’s knowledge, claim of any nature whatsoever upon any of the properties or assets of the Company, the result of any of which would have a Material Adverse Effect.

3.3 Validity. This Agreement has been duly executed and delivered by the Company and constitutes the valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, except (i) as limited by applicable bankruptcy, insolvency, reorganization, moratorium, fraudulent conveyance, or other laws of general application relating to or affecting the enforcement of creditors’ rights generally or (ii) as limited by laws relating to the availability of specific performance, injunctive relief, or other equitable remedies. The Notes when executed and delivered in accordance with this Agreement, will constitute the valid and binding obligations of the Company, enforceable against the Company in accordance with their respective terms, except (i) as limited by applicable bankruptcy, insolvency, reorganization, moratorium, fraudulent conveyance, or other laws of general application relating to or affecting the enforcement of creditors’ rights generally or (ii) as limited by laws relating to the availability of specific performance, injunctive relief, or other equitable remedies. The shares of the Company’s capital stock issuable upon conversion of the Notes when issued, sold and delivered or exchanged in accordance with the terms of this Agreement and the Notes, for the consideration provided for herein and therein, will be duly and validly issued, fully paid and nonassessable.

 

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3.4 Governmental Approvals. Subject to the accuracy of the representations and warranties of the Purchasers set forth in Section 4, no registration or filing with, or consent or approval of or other action by, any federal, state or other governmental agency or instrumentality is or will be necessary for the valid execution, delivery and performance by the Company of this Agreement or the issuance, sale and delivery of the Notes, other than filings pursuant to Regulation D of the Act and state securities laws (all of which filings have been or will be made by the Company) in connection with the sale of the Notes, if any.

3.5 Complete Disclosure. As of the Closing, the Company has made available to the Purchasers all the information that the Purchasers have requested in making their decision to acquire the Notes. To the Company’s knowledge, neither this Agreement nor any other documents or certificates furnished or to be furnished in connection herewith, when taken as a whole, contains any untrue statement of a material fact or omits to state a material fact necessary in order to make the statements contained herein or therein not misleading in light of the circumstances under which they were made.

4. REPRESENTATIONS AND WARRANTIES OF THE PURCHASERS.

In connection with the transactions provided for herein, each Purchaser hereby represents and warrants to the Company as of each Closing in which such Purchaser is participating, as follows:

4.1 Authorization. Such Purchaser is validly existing and has the requisite power and authority to execute and deliver this Agreement. This Agreement has been duly executed and delivered by such Purchaser, and constitutes the valid and legally binding obligation of such Purchaser, enforceable in accordance with its terms, except as such enforceability may be limited by (i) applicable bankruptcy, insolvency, reorganization, or similar laws relating to or affecting the enforcement of creditors’ rights and (ii) laws relating to the availability of specific performance, injunctive relief or other equitable remedies.

4.2 Purchase Entirely for Own Account. Such Purchaser acknowledges that this Agreement is made with such Purchaser in reliance upon such Purchaser’s representation to the Company that the Notes will be acquired for investment for such Purchaser’s own account, not as a nominee or agent, and not with a view to the resale or distribution of any part thereof, and that such Purchaser has no present intention of selling, granting any participation in, or otherwise distributing the same. By executing this Agreement, such Purchaser further represents that such Purchaser does not have any contract, undertaking, agreement or arrangement with any person to sell, transfer or grant participations to such person or to any third person, with respect to any of the Notes.

4.3 Disclosure of Information. Such Purchaser acknowledges that it has received all the information it considers necessary or appropriate for deciding whether to acquire the Notes. Such Purchaser further represents that it has had an opportunity to ask questions and receive answers from the Company regarding the terms and conditions of the offering of the Notes.

4.4 Investment Experience. Such Purchaser is an investor in securities of companies in the development stage and acknowledges that it is able to fend for itself, can bear the economic risk of its investment and has such knowledge and experience in financial or business matters that it is capable of evaluating the merits and risks of the investment in the Notes.

 

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4.5 Accredited Investor. Such Purchaser is an “accredited investor” within the meaning of Rule 501 of Regulation D promulgated under the Securities Act and has not been organized solely for the purpose of acquiring any of the Notes.

4.6 Restricted Securities. Such Purchaser understands that the Notes are characterized as “restricted securities” under the federal securities laws inasmuch as they are being acquired from the Company in a transaction or transactions not involving a public offering and that under such laws and applicable regulations such securities may be resold without registration under the Act only in certain limited circumstances. Such Purchaser represents that it is familiar with Rule 144 promulgated under the Securities Act, as presently in effect, and understands the resale limitations imposed thereby and by the Securities Act.

4.7 No General Solicitation. Neither the Purchaser, nor any of its officers, directors, employees, agents, stockholders or partners has either directly or indirectly, including through a broker or finder (a) engaged in any general solicitation or (b) published any advertisements in connection with the offer and sale of the Notes.

4.8 Bad Actor. Such Purchaser represents that neither it nor any of its Rule 506(d) Related Parties is a “bad actor” within the meaning of Rule 506(d) promulgated under the Securities Act. For purposes of this Agreement, “Rule 506(d) Related Parties” shall mean a “beneficial owner” of the Purchaser’s voting securities of the Company as provided under Rule 13d-3 under the Securities Exchange Act of 1934, as amended,

4.9 Legends. It is understood that the Notes may bear the legend in substantially the form set forth below, as well as other legends:

“THIS SECURITY AND THE SECURITIES ISSUABLE UPON THE CONVERSION OR EXERCISE OF THIS SECURITY HAS NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. THIS SECURITY MAY NOT BE SOLD, OFFERED FOR SALE, PLEDGED, HYPOTHECATED, OR OTHERWISE TRANSFERRED EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR AN OPINION OF COUNSEL SATISFACTORY TO THE COMPANY THAT REGISTRATION IS NOT REQUIRED UNDER SUCH ACT OR UNLESS SOLD PURSUANT TO RULE 144 UNDER SUCH ACT.”

5. CONDITIONS TO INITIAL CLOSING.

The respective and several obligations of each Purchaser to purchase and pay for the Notes to be purchased by it at the Initial Closing are subject to the fulfillment or waiver, on or before the Initial Closing, of each of the following conditions:

5.1 Representations and Warranties. Each of the representations and warranties of the Company set forth in Section 3 hereof shall be true in all material respects on the date of the Initial Closing.

5.2 Performance by the Company. The Company shall have performed and complied with all agreements, obligations and conditions contained in this Agreement that are required to be performed or complied with by it on or before the Initial Closing and shall have obtained all approvals, consents and qualifications necessary to complete the purchase and sale and exchange described herein and shall have delivered copies of such consents and approvals to the Purchasers.

 

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5.3 Delivery of Notes. The Company shall have executed and delivered to each Purchaser a Note, in the aggregate principal amount set forth the Purchaser’s name in the column “Initial Closing Notes ($)” on the Schedule of Purchasers.

6. CONDITIONS TO ADDITIONAL CLOSINGS.

The respective and several obligations of each Purchaser to purchase and pay for the Notes to be purchased by it at each Additional Closing are subject to the fulfillment or waiver, on or before the Additional Closing, of each of the following conditions:

6.1 Notice. The Company shall have received the Requisite Purchasers Notice and the Company shall have delivered to the Purchasers a Company Closing Notice, at least ten (10) Business Days prior to the scheduled date of the Additional Closing.

6.2 Representations and Warranties. Each of the representations and warranties of the Company set forth in Section 3 hereof shall be true in all material respects on the date of the Additional Closing.

6.3 Performance by the Company. The Company shall have performed and complied with all agreements, obligations and conditions contained in this Agreement that are required to be performed or complied with by it on or before the Additional Closing and shall have obtained all approvals, consents and qualifications necessary to complete the purchase and sale described herein.

6.4 Delivery of Notes. The Company shall have executed and delivered to each Purchaser a Note, in the aggregate principal amount set forth opposite its name on the Schedule of Purchasers in the column titled “Additional Closing 1 Notes ($)’’ or “Additional Closing 2 Notes ($)”, as applicable, being issued to such Purchaser at the Additional Closing.

7. MISCELLANEOUS.

7.1 Successors and Assigns. Except as otherwise provided herein, the terms and conditions of this Agreement shall inure to the benefit of and be binding upon the respective successors and assigns of the parties. Nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties hereto or their respective successors and assigns any rights, remedies, obligations or liabilities under or by reason of this Agreement, except as expressly provided in this Agreement.

7.2 Governing Law. This Agreement and the Notes, shall be governed by and construed under the laws of the State of Delaware, without regard to conflict of law principles.

7.3 Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. This Agreement may be executed by facsimile or other form of electronic communication.

7.4 Titles and Subtitles. The titles and subtitles used in this Agreement are used for convenience only and are not to be considered in construing or interpreting this Agreement.

7.5 Notices. All notices and other communications given or made pursuant to this Agreement and the Notes shall be in writing and shall be deemed effectively given: (i) upon personal delivery to the party to be notified, (ii) when sent by confirmed facsimile if sent during normal business hours of the recipient, if not so confirmed, then on the next Business Day, (iii) five (5) days after having

 

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been sent by registered or certified mail, return receipt requested, postage prepaid or (iv) one (1) Business Day after deposit with a nationally recognized overnight courier, specifying next day delivery, with written verification of receipt. All communications shall be sent to the respective parties at the following addresses (or at such other addresses as shall be specified by notice given in accordance with this Section 7.5):

If to the Company:

Q32 Bio Inc.

830 Winter Street

Waltham, MA 02451

Attention: Chief Financial Officer

If to Purchasers:

At the address on record with the Company.

7.6 Entire Agreement; Amendments and Waivers. This Agreement, the Notes, and the other documents delivered pursuant hereto or thereto constitute the full and entire understanding and agreement between and among the parties with regard to the subjects hereof and thereof. The Company’s agreements with each of the Purchasers are separate agreements, and the sales of the Notes to each of the Purchasers are separate sales. Notwithstanding anything to the contrary set forth herein, any term of this Agreement and the Notes may be amended and the observance of any term of this Agreement and the Notes may be waived (either generally or in a particular instance and either retroactively or prospectively), with the written consent of the Company and the Purchasers holding a majority of the principal amount of the Notes outstanding (the “Requisite Purchasers”), provided that no amendment shall be made to this Agreement or any Note that would increase a Purchaser’s committed investment amount without the prior written consent of such Purchaser. No amendment to or waiver of any provision of any Note, shall be made unless such amendment or waiver is made with respect to all the Notes.

7.7 Exculpation Among Purchasers. Each Purchaser acknowledges that it is not relying upon any person, firm, corporation or stockholder, other than the Company and its officers and directors in their capacities as such, in making its investment or decision to invest in the Company. Each Purchaser agrees that no other Purchaser nor the respective controlling persons, officers, directors, partners, agents, shareholders or employees of any other Purchaser shall be liable for any action heretofore or hereafter taken or omitted to be taken by any of them in connection with the purchase and sale of the Notes.

7.8 Severability. If one or more provisions of this Agreement are held to be unenforceable under applicable law, such provision shall be excluded from this Agreement and the balance of the Agreement shall be interpreted as if such provision were so excluded and shall be enforceable in accordance with its terms.

7.9 Waiver of Right of First Refusal. The undersigned Purchasers, constituting the holders of at least a majority of the Registrable Securities then outstanding (as defined in the Investors Rights Agreement (as defined below)), hereby waive the Investors’ right of first offer set forth in Section 4 of that certain Second Amended and Restated Investors’ Rights Agreement, dated as of August 31, 2020 (the “Investors Rights Agreement”), by and among the Company and the investors listed on Schedule A thereto, including any notice rights associated with the right of first offer, with respect to the issuance of the Notes, and any securities issuable upon conversion of the Notes.

 

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[Signature pages follow]

 

8


IN WITNESS WHEREOF, the parties have executed this Note Purchase Agreement as an instrument under seal as of the date first above written.

 

COMPANY:

Q32 BIO. INC.

By:   /s/ Michael Broxson

Name: Michael Broxson

Title: President and CEO

PURCHASERS:

ATLAS VENTURE OPPORTUNITY FUND II, L.P.
By: Atlas Venture Associates Opportunity II, L.P., its General Partner
By: Atlas Venture Associates Opportunity II, LLC, its General Partner
By:   /s/ Ommer Chohan

Name: Ommer Chohan

Title: CFO

 

9


PURCHASERS:
ORBIMED PRIVATE INVESTMENTS VII, LP

By: OrbiMed Capital GP VII LLC,

its General Partner

By: OrbiMed Advisors LLC,

its General Partner

By:   /s/ Carl Gordon

Name: Carl Gordon

Title: Member

ABINGWORTH BIOVENTURES VII LP ACTING BY ITS MANAGER ABINGWORTH LLP
By:   /s/ John Heard

Name: John Heard

Title: Partner, General Counsel

AVENTIS INC.
By:   /s/ Jason Hafler

Name: Jason Hafler

Title: Managing Director of Sanofi Ventures

 

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PURCHASERS:
CU HEALTHCARE INNOVATION FUND, L.P.

By: CU Healthcare Innovation G.P., LLC,

its General Partner

By:   /s/ Kimberly Muller
Name:   Kimberly Muller
Title:   General Partner

 

CHILDREN’S HOSPITAL COLORADO
By:   /s/ Jeffrey Harrington
Name:   Jeffrey Harrington
Title:   SVP, CFO

 

OSAGE UNIVERSITY PARTNERS III, LP
By: Osage University GP III, LLC, its General Partner
By:   /s/ William Harrington
Name:   William Harrington
Title:   Managing Member

 

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PURCHASERS:

THE TRUSTEES OF COLUMBIA UNIVERSITY

IN THE CITY OF NEW YORK

By:   /s/ Julius Mercado
Name:   Julius Mercado
Title:   COO, Columbia Investment Management Company, LLC

 

ACORN BIOVENTURES, L.P.
By: Acorn Capital Advisors GP, LLC
Its: General Partner
By:   /s/ Isaac Manke
Name:   Isaac Manke
Title:   Member

 

HARVARD MANAGEMENT PRIVATE EQUITY CORPORATION
By:   /s/ Richard Slocum
Name:   Richard Slocum
Title:   Authorized Signatory
By:   /s/ Kathryn Murtagh
Name:   Kathryn Murtagh
Title:   Authorized Signatory

 

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PURCHASERS:
BRISTOL-MYERS SQUIBB COMPANY
By:   /s/ Janeen Doyle
Name:   Janeen Doyle
Title:   SVP, Global Alliance

 

13


Exhibit A

[Omitted]

 

14

Exhibit 10.49

AMENDMENT NO. 1 TO

NOTE PURCHASE AGREEMENT

THIS AMENDMENT NO. 1 TO NOTE PURCHASE AGREEMENT (this “Amendment”) dated as of May 20, 2022 (the “Note Purchase Agreement”), is made as of August 3, 2022 by and among Q32 Bio Inc., a Delaware corporation (the “Company”), and the Purchasers listed on the signature pages hereto (the “Purchasers”).

RECITALS

WHEREAS, the Note Purchase Agreement may be amended pursuant to Section 7.6 thereof with the written consent of the Company and the Requisite Purchasers (the “Required Vote”);

WHEREAS, the Company and the undersigned Purchasers desire to amend the Note Purchase Agreement; and

WHEREAS, the Company and the undersigned Purchasers constitute the Required Vote;

NOW, THEREFORE, in consideration of the promises and conditions contained herein, the parties hereby agree as follows:

1. Amendment to Section 2.3. Section 2.3 of the Note Purchase Agreement is hereby amended and restated in its entirety to read as follows:

2.3 BMS Closing. After the Initial Closing, the Company may sell a Note, in the principal amount set forth on the Schedule of Purchasers in the column titled “BMS Closing Note ($)”, to BMS, on a date and time mutually agreed between the Company and BMS (the “BMS Closing”), provided that such purchase and sale takes place on or prior to August 15, 2022, or such later time as is approved by the Company’s Board of Directors. BMS shall deliver an executed counterpart signature page to this Agreement in connection with the BMS Closing, which will be held remotely via the exchange of documents and signatures.


2. Amendment to Section 2.4. The first sentence of Section 2.4 of the Note Purchase Agreement is hereby amended and restated in its entirety to read as follows:

2.4 Additional Closings. Following the Initial Closing and the BMS Closing, the Company may sell Notes, and the Purchasers may purchase Notes, at two additional closings of $8,333,334 aggregate principal amount of Notes at each such additional closing (each an “Additional Closing” and together, the “Additional Closings,” and together with the Initial Closing, the BMS Closing, and any Optional Closings (as defined below), the “Closings,” and each, a “Closing”) remotely via the exchange of documents and signatures on such dates occurring on or before December 31, 2022, as the Company, following approval by the Board of Directors to move forward with such Additional Closing, shall request in a written notice (the “Company Closing Notice”) to be delivered to the Purchasers at least ten (10) Business Days prior to the proposed date of the Additional Closing; provided that notwithstanding the foregoing, the Board of Directors may not elect to move forward with an Additional Closing until the Requisite Purchasers (as defined herein) have confirmed, in writing, that (i) the Company has not experienced a Material Adverse Effect (as defined herein) since the date of the last Closing and (ii) there has been no material deviation from the Operating Plan (the “Requisite Closing Notice”).

3. Amendment to Section 7.6. The first sentence of Section 7.6 of the Note Purchase Agreement is hereby amended and restated in its entirety to read as follows:

7.6 Entire Agreement; Amendments and Waivers. This Agreement, the Notes, any letter agreements between the Company and any Purchaser, and the other documents delivered pursuant hereto or thereto constitute the full and entire understanding and agreement between and among the parties with regard to the subjects hereof and thereof.

4. Amendment to Schedule I. Schedule I to the Note Purchase Agreement is hereby amended in its entirety to read as set forth on Exhibit A attached hereto.

5. Continued Validity of the Note Purchase Agreement. Except as specifically amended hereby, the Note Purchase Agreement shall continue in full force and effect as originally constituted and is ratified and affirmed by the parties hereto.

6. Additional Party. By execution of this Amendment, BMS shall become a party to the Note Purchase Agreement, effective as of the date of this Amendment as if originally specified as a party thereto.

7. Representations and Warranties. The Company hereby makes each of the representations and warranties set forth in Section 3 of the Note Purchase Agreement (Representations and Warranties of the Company) as of the date of this Amendment. For the benefit of the Company, BMS hereby makes (solely with respect to itself) each of the representations and warranties set forth in Section 4 of the Note Purchase Agreement (Representations and Warranties of the Purchasers) as of the date of this Amendment.

8. Successors and Assigns. Except as otherwise provided herein, the terms and conditions of this Amendment shall inure to the benefit of and be binding upon the respective successors and assigns of the parties.

9. Governing Law. This Amendment shall be governed by and construed in accordance with the laws of the State of Delaware, without giving effect to the conflict of laws principles thereof.


10. Counterparts. This Amendment may be executed in counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

[Signature Page Follows]


IN WITNESS WHEREOF, each of the parties has executed this Amendment No. 1 to Note Purchase Agreement as of August 3, 2022.

 

COMPANY:

Q32 BIO INC.

By:   /s/ Michael Broxson
Name: Michael Broxson
Title: President and CEO


IN WITNESS WHEREOF, each of the parties has executed this Amendment No. 1 to Note Purchase Agreement as of August 3, 2022.

 

PURCHASERS:
ATLAS VENTURE OPPORTUNITY FUND II, L.P.
By: Atlas Venture Associates Opportunity II, L.P., its General Partner
By: Atlas Venture Associates Opportunity II, LLC, its General Partner
By:  

/s/ Ommer Chohan

Name: Ommer Chohan
Title: CFO
ORBIMED PRIVATE INVESTMENTS VII, LP

By: OrbiMed Capital GP VII LLC,

its General Partner

By: OrbiMed Advisors LLC,
its General Partner
By:  

/s/ Carl L. Gordon

Name: Carl L. Gordon
Title: Member

ABINGWORTH BIOVENTURES VII LP

ACTING BY ITS MANAGER ABINGWORTH LLP

By:

 

/s/ John Heard

Name: John Heard

Title: General Counsel


PURCHASERS:

AVENTIS INC.

By:

 

/s/ Jason Hafler

Name: Jason Hafler

Title: Managing Director Sanofi Ventures

OSAGE UNIVERSITY PARTNERS III, LP

By: Osage University GP III, LLC, its General Partner

By:

 

/s/ William Harrington

Name: William Harrington

Title: Managing Member

ACORN BIOVENTURES, L.P.

By: Acorn Capital Advisors GP, LLC

Its: General Partner

By:

 

/s/ Isaac Manke

Name: Isaac Manke

Title: Member


PURCHASERS:

BRISTOL-MYERS SQUIBB COMPANY

By:

 

/s/ Janeen Doyle

Name: Janeen Doyle

Title: SVP, Global Alliance

Exhibit 10.50

LOAN AND SECURITY AGREEMENT

THIS LOAN AND SECURITY AGREEMENT (this “Agreement”) dated as of December 11, 2020 (the “Effective Date”) between SILICON VALLEY BANK, a California corporation (“Bank”), and Q32 BIO INC., a Delaware corporation (“Borrower”), provides the terms on which Bank shall lend to Borrower and Borrower shall repay Bank. The parties agree as follows:

1. ACCOUNTING AND OTHER TERMS

Accounting terms not defined in this Agreement shall be construed following GAAP. Calculations and determinations must be made following GAAP. Notwithstanding the foregoing, all financial covenant (if any) and other financial calculations shall be computed with respect to Borrower only, and not on a consolidated basis. Capitalized terms not otherwise defined in this Agreement shall have the meanings set forth in Section 13. All other terms contained in this Agreement, unless otherwise indicated, shall have the meaning provided by the Code to the extent such terms are defined therein.

2. LOAN AND TERMS OF PAYMENT

2.1 Promise to Pay. Borrower hereby unconditionally promises to pay Bank the outstanding principal amount of all Credit Extensions and accrued and unpaid interest thereon as and when due in accordance with this Agreement.

2.1.1 Term Loan Advances.

(a) Availability. Subject to the terms and conditions of this Agreement, Bank shall make one (1) term loan advance (the “Term A Loan Advance”) on or about the Effective Date in an original principal amount of Five Million Dollars ($5,000,000.00). Subject to the terms and conditions of this Agreement, during Draw Period 1, upon Borrower’s request, Bank shall make one (1) term loan advance (the “Term B Loan Advance”) available to Borrower in an original principal amount of Seven Million Five Hundred Thousand Dollars ($7,500,000.00). Subject to the terms and conditions of this Agreement, during Draw Period 2, upon Borrower’s request, Bank shall make one (1) term loan advance (the “Term C Loan Advance”) available to Borrower in an original principal amount of Six Million Two Hundred Fifty Thousand Dollars ($6,250,000.00). Subject to the terms and conditions of this Agreement, during Draw Period 3, upon Borrower’s request, Bank shall make one (1) term loan advance (the “Term D Loan Advance”) available to Borrower in an original principal amount of Six Million Two Hundred Fifty Thousand Dollars ($6,250,000.00). The Term A Loan Advance, the Term B Loan Advance, the Term C Loan Advance, and the Term D Loan Advance are each hereinafter referred to singly as a “Term Loan Advance” and collectively as the “Term Loan Advances”. After repayment, no Term Loan Advance (or any portion thereof) may be reborrowed.

(b) Interest Period. Commencing on the first (1st) Payment Date of the month following the month in which the Funding Date of the applicable Term Loan Advance occurs, and continuing on each Payment Date thereafter, Borrower shall make monthly payments of interest on the principal amount of each Term Loan Advance at the rate set forth in Section 2.2(a).

(c) Repayment. Commencing on the Term Loan Amortization Date, and continuing on each Payment Date thereafter, Borrower shall repay the aggregate outstanding Term Loan Advances in (i) consecutive equal monthly installments of principal according to the Repayment Schedule, plus (ii) monthly payments of accrued interest at the rate set forth in Section 2.2(a). All outstanding principal and accrued and unpaid interest with respect to the Term Loan Advances, and all other outstanding Obligations with respect to the Term Loan Advances, are due and payable in full on the Term Loan Maturity Date.


(d) Mandatory Prepayment Upon an Acceleration. If the Term Loan Advances are accelerated following the occurrence and during the continuance of an Event of Default, Borrower shall immediately pay to Bank an amount equal to the sum of: (i) all outstanding principal plus accrued and unpaid interest with respect to the Term Loan Advances, plus (ii) the Prepayment Premium, (iii) the Final Payment, and (iv) all other sums, if any, that shall have become due and payable with respect to the Term Loan Advances, including interest at the Default Rate with respect to any past due amounts.

(e) Permitted Prepayment of Term Loan Advances. Borrower shall have the option to prepay all, but not less than all, of the Term Loan Advances advanced by Bank under this Agreement, provided Borrower (i) provides written notice to Bank of its election to prepay the Term Loan Advances at least five (5) days prior to such prepayment, and (ii) pays, on the date of such prepayment (A) all outstanding principal plus accrued and unpaid interest with respect to the Term Loan Advances, (B) the Prepayment Premium, (C) the Final Payment, and (D) all other sums, if any, that shall have become due and payable with respect to the Term Loan Advances, including interest at the Default Rate with respect to any past due amounts.

2.2 Payment of Interest on the Credit Extensions.

(a) Interest Rate. Subject to Section 2.2(b), the principal amount outstanding under each Term Loan Advance shall accrue interest at a floating per annum rate equal to the greater of (A) the Prime Rate and (B) three and one-quarter of one percent (3.25%), which interest, in each case, shall be payable monthly in accordance with Section 2.2(d) below.

(b) Default Rate. Immediately upon the occurrence and during the continuance of an Event of Default, Obligations shall bear interest at a rate per annum which is five percent (5.0%) above the rate that is otherwise applicable thereto (the “Default Rate”) unless Bank otherwise elects from time to time in its sole discretion to impose a smaller increase. Fees and expenses which are required to be paid by Borrower pursuant to the Loan Documents (including, without limitation, Bank Expenses) but are not paid when due shall bear interest until paid at a rate equal to the highest rate applicable to the Obligations. Payment or acceptance of the increased interest rate provided in this Section 2.2(b) is not a permitted alternative to timely payment and shall not constitute a waiver of any Event of Default or otherwise prejudice or limit any rights or remedies of Bank.

(c) Adjustment to Interest Rate. Changes to the interest rate of any Credit Extension based on changes to the Prime Rate shall be effective on the effective date of any change to the Prime Rate and to the extent of any such change.

(d) Payment; Interest Computation. Interest is payable monthly in arrears on the Payment Date and shall be computed on the basis of a 360-day year for the actual number of days elapsed. In computing interest, (i) all payments received after 1:00 p.m. Eastern time on any day shall be deemed received at the opening of business on the next Business Day, and (ii) the date of the making of any Credit Extension shall be included and the date of payment shall be excluded; provided, however, that if any Credit Extension is repaid on the same day on which it is made, such day shall be included in computing interest on such Credit Extension.

2.3 Fees. Borrower shall pay to Bank:

(a) Prepayment Premium. The Prepayment Premium, if and when due hereunder;

(b) Final Payment. The Final Payment, when due hereunder;

 

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(c) Good Faith Deposit. Borrower has paid to Bank a good faith deposit of Fifty Thousand Dollars ($50,000.00) (the “Good Faith Deposit”) prior to the date hereof which shall be applied toward Bank Expenses incurred through the Effective Date; and

(d) Bank Expenses. All Bank Expenses (including reasonable and documented attorneys’ fees and out-of-pocket expenses for documentation and negotiation of this Agreement) incurred through and after the Effective Date, when due (or, if no stated due date, upon demand by Bank).

Unless otherwise provided in this Agreement or in a separate writing by Bank, Borrower shall not be entitled to any credit, rebate, or repayment of any fees earned by Bank pursuant to this Agreement notwithstanding any termination of this Agreement or the suspension or termination of Bank’s obligation to make loans and advances hereunder. Bank may deduct amounts owing by Borrower under the clauses of this Section 2.3 pursuant to the terms of Section 2.4(c). Bank shall provide Borrower written notice of deductions made from the Designated Deposit Account pursuant to the terms of the clauses of this Section 2.3.

2.4 Payments; Application of Payments; Debit of Accounts.

(a) All payments to be made by Borrower under any Loan Document shall be made in immediately available funds in Dollars, without setoff or counterclaim, before 1:00 p.m. Eastern time on the date when due. Payments of principal and/or interest received after 1:00 p.m. Eastern time are considered received at the opening of business on the next Business Day. When a payment is due on a day that is not a Business Day, the payment shall be due the next Business Day, and additional fees or interest, as applicable, shall continue to accrue until paid.

(b) Bank has the exclusive right to determine the order and manner in which all payments with respect to the Obligations may be applied. Borrower shall have no right to specify the order or the accounts to which Bank shall allocate or apply any payments required to be made by Borrower to Bank or otherwise received by Bank under this Agreement when any such allocation or application is not specified elsewhere in this Agreement.

(c) Bank may debit any of Borrower’s deposit accounts (other than the Excluded Accounts), including the Designated Deposit Account, for principal and interest payments or any other amounts Borrower owes Bank when due hereunder. These debits shall not constitute a set-off.

2.5 Withholding. Payments received by Bank from Borrower under this Agreement will be made free and clear of and without deduction for any and all present or future taxes, levies, imposts, duties, deductions, withholdings, assessments, fees or other charges imposed by any Governmental Authority (including any interest, additions to tax or penalties applicable thereto). Specifically, however, if at any time any Governmental Authority, applicable law, regulation or international agreement requires Borrower to make any withholding or deduction from any such payment or other sum payable hereunder to Bank, Borrower hereby covenants and agrees that the amount due from Borrower with respect to such payment or other sum payable hereunder will be increased to the extent necessary to ensure that, after the making of such required withholding or deduction, Bank receives a net sum equal to the sum which it would have received had no withholding or deduction been required, and Borrower shall pay the full amount withheld or deducted to the relevant Governmental Authority provided however that to the extent Bank is refunded any portion of such excess, Bank shall remit such amount to Borrower. Borrower will, upon request, furnish Bank with proof reasonably satisfactory to Bank indicating that Borrower has made such withholding payment; provided, however, that Borrower need not make any withholding payment if the amount or validity of such withholding payment is contested in good faith by appropriate and timely proceedings and as to which payment in full is bonded or reserved against by Borrower. The agreements and obligations of Borrower contained in this Section 2.5 shall survive the termination of this Agreement.

 

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3. CONDITIONS OF LOANS

3.1 Conditions Precedent to Initial Credit Extension. Bank’s obligation to make the initial Credit Extension is subject to the condition precedent that Bank shall have received, in form and substance satisfactory to Bank, such documents, and completion of such other matters, as Bank may have reasonably requested, including, without limitation:

(a) duly executed signatures to the Loan Documents;

(b) duly executed signatures to the Warrant;

(c) duly executed signatures to the Control Agreement (if any);

(d) the Operating Documents and (i) a long-form good standing certificate of Borrower certified by the Secretary of State of Delaware and (ii) a foreign qualification certificate of Borrower certified by the Secretary of the Commonwealth of the Commonwealth of Massachusetts, each as of a date no earlier than thirty (30) days prior to the Effective Date;

(e) a secretary’s corporate borrowing certificate of Borrower with respect to Borrower’s Operating Documents and resolutions authorizing the execution and delivery of this Agreement and the other Loan Documents;

(f) duly executed signatures to the completed Borrowing Resolutions for Borrower;

(g) certified copies, dated as of a recent date, of financing statement searches, as Bank may request, accompanied by written evidence (including any UCC termination statements) that the Liens indicated in any such financing statements either constitute Permitted Liens or have been or, in connection with the initial Credit Extension, will be terminated or released;

(h) the Perfection Certificate of Borrower, together with the duly executed signature thereto;

(i) duly executed signatures to the Stock Pledge Agreement;

(j) a legal opinion of Borrower’s counsel dated as of the Effective Date together with the duly executed signature thereto;

(k) evidence on Acord 25 and 28 certificates satisfactory to Bank that the insurance policies required by Section 6.5 hereof are in full force and effect; and

(l) payment of the fees and Bank Expenses then due as specified in Section 2.3 hereof.

3.2 Conditions Precedent to all Credit Extensions. Bank’s obligations to make each Credit Extension, including the initial Credit Extension, are subject to the following conditions precedent:

(a) except as otherwise provided in Section 3.4, timely receipt of an executed Payment/Advance Form;

 

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(b) the representations and warranties in this Agreement shall be true, accurate, and complete in all material respects on the date of the Payment/Advance Form and on the Funding Date of each Credit Extension; provided, however, that such materiality qualifier shall not be applicable to any representations and warranties that already are qualified or modified by materiality in the text thereof; and provided, further that those representations and warranties expressly referring to a specific date shall be true, accurate and complete in all material respects as of such date, and no Event of Default shall have occurred and be continuing or result from the Credit Extension. Each Credit Extension is Borrower’s representation and warranty on that date that the representations and warranties in this Agreement are true, accurate, and complete in all material respects as of such date; provided, however, that such materiality qualifier shall not be applicable to any representations and warranties that already are qualified or modified by materiality in the text thereof; and provided, further that those representations and warranties expressly referring to a specific date shall be true, accurate and complete in all material respects as of such date; and

(c) Bank determines to its reasonable satisfaction that there has not been any material impairment in the general affairs, management, results of operation, financial condition or the prospect of repayment of the Obligations when due, nor any material adverse deviation by Borrower from the most recent business plan of Borrower presented to and accepted by Bank.

3.3 Covenant to Deliver. Borrower agrees to deliver to Bank each item required to be delivered to Bank under this Agreement as a condition precedent to any Credit Extension. Borrower expressly agrees that a Credit Extension made prior to the receipt by Bank of any such item shall not constitute a waiver by Bank of Borrower’s obligation to deliver such item, and the making of any Credit Extension in the absence of a required item shall be in Bank’s sole discretion.

3.4 Procedures for Borrowing. Subject to the prior satisfaction of all other applicable conditions to the making of a Credit Extension set forth in this Agreement, to obtain a Credit Extension, Borrower shall notify Bank (which notice shall be irrevocable) by electronic mail, facsimile, or telephone by 1:00 p.m. Eastern time at least two (2) Business Days prior to the proposed Funding Date of such Credit Extension. Together with any such electronic or facsimile notification, Borrower shall deliver to Bank by electronic mail or facsimile a completed Payment/Advance Form executed by an Authorized Signer. Bank may rely on any telephone notice given by a person whom Bank reasonably believes is an Authorized Signer. Bank shall credit the Credit Extensions to the Designated Deposit Account. Bank may make Credit Extensions under this Agreement based on instructions from an Authorized Signer or without instructions if the Credit Extensions are necessary to meet Obligations which have become due.

4. CREATION OF SECURITY INTEREST

4.1 Grant of Security Interest. Borrower hereby grants Bank, to secure the payment and performance in full of all of the Obligations, a continuing security interest in, and pledges to Bank, the Collateral, wherever located, whether now owned or hereafter acquired or arising, and all proceeds and products thereof.

Borrower acknowledges that it previously has entered, and/or may in the future enter, into Bank Services Agreements with Bank. Regardless of the terms of any Bank Services Agreement, Borrower agrees that any amounts Borrower owes Bank thereunder shall be deemed to be Obligations hereunder and that it is the intent of Borrower and Bank to have all such Obligations secured by the first priority perfected security interest in the Collateral granted herein (subject only to Permitted Liens that are permitted pursuant to the terms of this Agreement to have superior priority to Bank’s Lien in this Agreement).

 

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If this Agreement is terminated, Bank’s Lien in the Collateral shall continue until the Obligations (other than inchoate indemnity obligations) are repaid in full in cash. Upon payment in full in cash of the Obligations (other than inchoate indemnity obligations) and at such time as Bank’s obligation to make Credit Extensions has terminated, Bank shall, at the sole cost and expense of Borrower, release its Liens in the Collateral and all rights therein shall revert to Borrower. In the event (x) all Obligations (other than inchoate indemnity obligations), except for Bank Services, are satisfied in full, and (y) this Agreement is terminated, Bank shall terminate the security interest granted herein upon Borrower providing cash collateral acceptable to Bank in its good faith business judgment for Bank Services, if any. In the event such Bank Services consist of outstanding Letters of Credit, Borrower shall provide to Bank cash collateral in an amount equal to (x) if such Letters of Credit are denominated in Dollars, then at least one hundred five percent (105.0%); and (y) if such Letters of Credit are denominated in a Foreign Currency, then at least one hundred ten percent (110.0%), of the Dollar Equivalent of the face amount of all such Letters of Credit plus, in each case, all interest, fees, and costs due or to become due in connection therewith (as estimated by Bank in its good faith business judgment), to secure all of the Obligations relating to such Letters of Credit.

4.2 Priority of Security Interest. Borrower represents, warrants, and covenants that the security interest granted herein is and shall at all times continue to be a first priority perfected security interest in the Collateral (subject only to Permitted Liens that are permitted pursuant to the terms of this Agreement to have superior priority to Bank’s Lien under this Agreement). If Borrower shall acquire a commercial tort claim, Borrower shall promptly notify Bank in a writing signed by Borrower of the general details thereof and grant to Bank in such writing a security interest therein and in the proceeds thereof, all upon the terms of this Agreement, with such writing to be in form and substance reasonably satisfactory to Bank.

4.3 Authorization to File Financing Statements. Borrower hereby authorizes Bank to file financing statements, without notice to Borrower, with all appropriate jurisdictions to perfect or protect Bank’s interest or rights hereunder, including a notice that any disposition of the Collateral, by either Borrower or any other Person, shall be deemed to violate the rights of Bank under the Code. Such financing statements may indicate the Collateral as “all assets of the Debtor” or words of similar effect, or as being of an equal or lesser scope, or with greater detail, all in Bank’s discretion.

5. REPRESENTATIONS AND WARRANTIES

Borrower represents and warrants as follows:

5.1 Due Organization, Authorization; Power and Authority. Borrower is duly existing and in good standing as a Registered Organization in its jurisdiction of formation and is qualified and licensed to do business and is in good standing in any jurisdiction in which the conduct of its business or its ownership of property requires that it be qualified except where the failure to do so could not reasonably be expected to have a material adverse effect on Borrower’s business. In connection with this Agreement, Borrower has delivered to Bank a completed certificate signed by Borrower, entitled “Perfection Certificate” (the “Perfection Certificate”). Borrower represents and warrants to Bank that (a) Borrower’s exact legal name is that indicated on the Perfection Certificate and on the signature page hereof; (b) Borrower is an organization of the type and is organized in the jurisdiction set forth in the Perfection Certificate; (c) the Perfection Certificate accurately sets forth Borrower’s organizational identification number or accurately states that Borrower has none; (d) the Perfection Certificate accurately sets forth Borrower’s place of business, or, if more than one, its chief executive office as well as Borrower’s mailing address (if different than its chief executive office); (e) Borrower (and each of its predecessors) has not, in the past five (5) years, changed its jurisdiction of formation, organizational structure or type, or any organizational number assigned by its jurisdiction; and (f) all other information set forth on the Perfection Certificate pertaining to Borrower and each of its Subsidiaries is accurate and complete (it being understood and agreed that Borrower may from time to time update certain information in the Perfection Certificate after the Effective Date to the extent permitted by one or more specific provisions in this Agreement). If Borrower is not now a Registered Organization but later becomes one, Borrower shall promptly notify Bank of such occurrence and provide Bank with Borrower’s organizational identification number.

 

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The execution, delivery and performance by Borrower of the Loan Documents to which it is a party have been duly authorized, and do not (i) conflict with any of Borrower’s organizational documents, (ii) contravene, conflict with, constitute a default under or violate any material Requirement of Law, (iii) contravene, conflict or violate any applicable order, writ, judgment, injunction, decree, determination or award of any Governmental Authority by which Borrower or any of its Subsidiaries or any of their property or assets may be bound or affected, (iv) require any action by, filing, registration, or qualification with, or Governmental Approval from, any Governmental Authority (except such Governmental Approvals which have already been obtained and are in full force and effect (or are being obtained pursuant to Section 6.1(b)) or (v) conflict with, contravene, constitute a default or breach under, or result in or permit the termination or acceleration of, any material agreement by which Borrower is bound. Borrower is not in default under any agreement to which it is a party or by which it is bound in which the default could reasonably be expected to have a material adverse effect on Borrower’s business.

5.2 Collateral. Borrower has good title to, rights in, and the power to transfer each item of the Collateral upon which it purports to grant a Lien hereunder, free and clear of any and all Liens except Permitted Liens. Borrower has no Collateral Accounts at or with any bank or financial institution other than Bank or Bank’s Affiliates except for the Collateral Accounts described in the Perfection Certificate delivered to Bank in connection herewith and which Borrower has taken such actions as are necessary to give Bank a perfected security interest therein, pursuant to the terms of Section 6.6(b). The Accounts are bona fide, existing obligations of the Account Debtors.

The Collateral is not in the possession of any third party bailee (such as a warehouse) except as otherwise provided in the Perfection Certificate. None of the components of the Collateral (other than mobile equipment such as laptop computers in the possession of Borrower’s employees or agents) shall be maintained at locations other than as provided in the Perfection Certificate or as permitted pursuant to Section 7.2.

All Inventory is in all material respects of good and marketable quality, free from material defects.

Borrower is the sole owner of the Intellectual Property which it owns or purports to own except for (a) non-exclusive licenses granted to its customers in the ordinary course of business, (b) over-the-counter software that is commercially available to the public, and (c) material Intellectual Property licensed to Borrower and noted on the Perfection Certificate. Each Patent which it owns or purports to own and which is material to Borrower’s business is valid and enforceable, and no part of the Intellectual Property which Borrower owns or purports to own and which is material to Borrower’s business has been judged invalid or unenforceable, in whole or in part. To Borrower’s knowledge, no claim has been made that any part of the Intellectual Property violates the rights of any third party except to the extent such claim would not reasonably be expected to have a material adverse effect on Borrower’s business.

Except as noted on the Perfection Certificate, Borrower is not a party to, nor is it bound by, any Restricted License.

5.3 Litigation. There are no actions or proceedings pending or, to the knowledge of any Responsible Officer, threatened in writing by or against Borrower or any of its Subsidiaries involving more than, individually or in the aggregate, Two Hundred Fifty Thousand Dollars ($250,000.00).

 

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5.4 Financial Statements; Financial Condition. All consolidated financial statements for Borrower and any of its Subsidiaries delivered to Bank by submission to the Financial Statement Repository or otherwise submitted to Bank fairly present in all material respects Borrower’s consolidated financial condition and Borrower’s consolidated results of operations as of the date of such financial statements. There has not been any material deterioration in Borrower’s consolidated financial condition since the date of the most recent financial statements submitted to the Financial Statement Repository or otherwise submitted to Bank.

5.5 Solvency. The fair salable value of Borrower’s consolidated assets (including goodwill minus disposition costs) exceeds the fair value of Borrower’s liabilities; Borrower is not left with unreasonably small capital after the transactions in this Agreement; and Borrower is able to pay its debts (including trade debts) as they mature.

5.6 Regulatory Compliance. Borrower is not an “investment company” or a company “controlled” by an “investment company” under the Investment Company Act of 1940, as amended. Borrower is not engaged as one of its important activities in extending credit for margin stock (under Regulations X, T and U of the Federal Reserve Board of Governors). Borrower (a) has complied in all material respects with all Requirements of Law, and (b) has not violated any Requirements of Law the violation of which could reasonably be expected to have a material adverse effect on its business. None of Borrower’s or any of its Subsidiaries’ properties or assets has been used by Borrower or any Subsidiary or, to Borrower’s knowledge, by previous Persons, in disposing, producing, storing, treating, or transporting any hazardous substance other than legally. Borrower and each of its Subsidiaries have obtained all consents, approvals and authorizations of, made all declarations or filings with, and given all notices to, all Governmental Authorities that are necessary to continue their respective businesses as currently conducted.

5.7 Subsidiaries; Investments. Borrower does not own any stock, partnership, or other ownership interest or other equity securities except for Permitted Investments.

5.8 Tax Returns and Payments; Pension Contributions. Borrower has timely filed all required tax returns and reports, and Borrower has timely paid all foreign, federal, state and local taxes, assessments, deposits and contributions owed by Borrower except (a) to the extent such taxes are being contested in good faith by appropriate proceedings promptly instituted and diligently conducted, so long as such reserve or other appropriate provision, if any, as shall be required in conformity with GAAP shall have been made therefor, or (b) if such taxes, assessments, deposits and contributions do not, individually or in the aggregate, exceed Ten Thousand Dollars ($10,000.00).

To the extent Borrower defers payment of any contested taxes, Borrower shall (i) notify Bank in writing of the commencement of, and any material development in, the proceedings, and (ii) post bonds or take any other steps required to prevent the Governmental Authority levying such contested taxes from obtaining a Lien upon any of the Collateral that is other than a Permitted Lien. Borrower is unaware of any claims or adjustments proposed for any of Borrower’s prior tax years which could result in additional taxes becoming due and payable by Borrower in excess of Ten Thousand Dollars ($10,000.00). Borrower has paid all amounts necessary to fund all present pension, profit sharing and deferred compensation plans in accordance with their terms, and Borrower has not withdrawn from participation in, and has not permitted partial or complete termination of, or permitted the occurrence of any other event with respect to, any such plan which could reasonably be expected to result in any liability of Borrower, including any liability to the Pension Benefit Guaranty Corporation or its successors or any other governmental agency.

5.9 Use of Proceeds. Borrower shall use the proceeds of the Credit Extensions as working capital and to fund its general business requirements and not for personal, family, household or agricultural purposes.

 

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5.10 Full Disclosure. No written representation, warranty or other statement of Borrower in any report, certificate or written statement submitted to the Financial Statement Repository, as of the date such representation, warranty, or other statement was made, taken together with all such written reports, written certificates or written statements submitted to the Financial Statement Repository, contains any untrue statement of a material fact or omits to state a material fact necessary to make the statements contained in the reports, certificates, or written statements not misleading in light of the circumstances in which they were made (it being recognized by Bank that the projections and forecasts provided by Borrower in good faith and based upon reasonable assumptions are not viewed as facts and that actual results during the period or periods covered by such projections and forecasts may differ from the projected or forecasted results).

5.11 Definition of “Knowledge.” For purposes of the Loan Documents, whenever a representation or warranty is made to Borrower’s knowledge or awareness, to the “best of” Borrower’s knowledge, or with a similar qualification, knowledge or awareness means the actual knowledge, after reasonable investigation, of any Responsible Officer.

6. AFFIRMATIVE COVENANTS

Borrower shall do all of the following:

6.1 Government Compliance.

(a) Maintain its and (except as permitted by Section 7.3) all its Subsidiaries’ legal existence and good standing in their respective jurisdictions of formation and maintain qualification in each jurisdiction in which the failure to so qualify would reasonably be expected to have a material adverse effect on Borrower’s business or operations. Borrower shall comply, and have each Subsidiary comply, in all material respects, with all laws, ordinances and regulations to which it is subject.

(b) Obtain all of the Governmental Approvals necessary for the performance by Borrower of its obligations under the Loan Documents to which it is a party and the grant of a security interest to Bank in the Collateral. Borrower shall promptly provide copies of any such obtained Governmental Approvals to Bank.

6.2 Financial Statements, Reports. Provide Bank with the following by submitting to the Financial Statement Repository:

(a) Monthly Financial Statements. As soon as available, but no later than thirty (30) days after the last day of each month, a company prepared consolidated balance sheet and income statement covering Borrower’s consolidated operations for such month in a form of presentation reasonably acceptable to Bank (the “Monthly Financial Statements”);

(b) Monthly Compliance Statement. Within thirty (30) days after the last day of each month and together with the Monthly Financial Statements a completed Compliance Statement, confirming that, as of the end of such month, Borrower was in full compliance with all of the terms and conditions of this Agreement, and setting forth calculations showing compliance with the financial covenants set forth in this Agreement (if any) and such other information as Bank may reasonably request;

(c) Annual Audited Financial Statements. As soon as available, but no later than one hundred eighty (180) days after the last day of Borrower’s fiscal year, audited consolidated financial statements prepared under GAAP, consistently applied, together with an unqualified opinion on the financial statements from an independent certified public accounting firm reasonably acceptable to Bank;

 

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(d) Board-Approved Projections. At least annually, but no later than sixty (60) days after the last day of each fiscal year of Borrower, and contemporaneously with any material updates or changes thereto, annual Board-approved operating budgets and financial projections, in a form acceptable to Bank;

(e) Other Statements. Within five (5) days of delivery, copies of all statements, reports and notices made available to Borrower’s security holders or to any holders of Subordinated Debt;

(f) SEC Filings. In the event that Borrower becomes subject to the reporting requirements under the Exchange Act within five (5) days of filing, copies of all periodic and other reports, proxy statements and other materials filed by Borrower with the SEC, any Governmental Authority succeeding to any or all of the functions of the SEC or with any national securities exchange, or distributed to its shareholders, as the case may be. Documents required to be delivered pursuant to the terms hereof (to the extent any such documents are included in materials otherwise filed with the SEC) may be delivered electronically and if so delivered, shall be deemed to have been delivered on the date on which Borrower posts such documents, or provides a link thereto, on Borrower’s website on the internet at Borrower’s website address; provided, however, Borrower shall promptly notify Bank in writing (which may be by electronic mail) of the posting of any such documents;

(g) Beneficial Ownership Information. Prompt written notice of any changes to the beneficial ownership information set out in Section 14 of the Perfection Certificate. Borrower understands and acknowledges that Bank relies on such true, accurate and up-to-date beneficial ownership information to meet Bank’s regulatory obligations to obtain, verify and record information about the beneficial owners of its legal entity customers;

(h) Legal Action Notice. A prompt report of any legal actions pending or threatened in writing against Borrower or any of its Subsidiaries that could result in damages or costs to Borrower or any of its Subsidiaries of, individually or in the aggregate, Two Hundred Fifty Thousand Dollars ($250,000.00) or more; and

(i) Other Financial Information. Other financial information regarding Borrower as reasonably requested by Bank.

Any submission by Borrower of a Compliance Statement or any other financial statement submitted to the Financial Statement Repository pursuant to this Section 6.2 shall be deemed to be a representation by Borrower that (a) as of the date of such Compliance Statement or other financial statement, the information and calculations set forth therein are true, accurate and correct, (b) as of the end of the compliance period set forth in such submission, Borrower is in compliance with all required covenants except as noted in such Compliance Statement or other financial statement, as applicable; (c) as of the date of such submission, no Events of Default have occurred or are continuing; (d) all representations and warranties other than any representations or warranties that are made as of a specific date in Section 5 remain true and correct in all material respects as of the date of such submission except as noted in such Compliance Statement or other financial statement, as applicable; (e) as of the date of such submission, Borrower and each of its Subsidiaries has timely filed all required tax returns and reports, and Borrower has timely paid all foreign, federal, state and local taxes, assessments, deposits and contributions owed by Borrower except as otherwise permitted pursuant to the terms of Section 5.8; and (f) as of the date of such submission, no Liens have been levied or claims made against Borrower or any of its Subsidiaries relating to unpaid employee payroll or benefits of which Borrower has not previously provided written notification to Bank.

 

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6.3 Inventory; Returns. Keep all Inventory in good and marketable condition, free from material defects. Returns and allowances between Borrower and its Account Debtors shall follow Borrower’s customary practices as they exist at the Effective Date. Borrower must promptly notify Bank of all returns, recoveries, disputes and claims that involve more than One Hundred Thousand Dollars ($100,000.00).

6.4 Taxes; Pensions. Timely file, and require each of its Subsidiaries to timely file, all required tax returns and reports and timely pay, and require each of its Subsidiaries to timely pay, all foreign, federal, state and local taxes, assessments, deposits and contributions owed by Borrower and each of its Subsidiaries, except for deferred payment of any taxes contested pursuant to the terms of Section 5.8 hereof, and shall deliver to Bank, on demand, appropriate certificates attesting to such payments, and pay all amounts necessary to fund all present pension, profit sharing and deferred compensation plans in accordance with their terms.

6.5 Insurance.

(a) Keep its business and the Collateral insured for risks and in amounts standard for companies in Borrower’s industry and location and as Bank may reasonably request. Insurance policies shall be in a form, with financially sound and reputable insurance companies that are not Affiliates of Borrower, and in amounts that are satisfactory to Bank. All property policies shall have a lender’s loss payable endorsement showing Bank as lender loss payee. All liability policies shall show, or have endorsements showing, Bank as an additional insured. Bank shall be named as lender loss payee and/or additional insured with respect to any such insurance providing coverage in respect of any Collateral.

(b) Ensure that proceeds payable under any property policy are, at Bank’s option, payable to Bank on account of the Obligations. Notwithstanding the foregoing, (a) so long as no Event of Default has occurred and is continuing, Borrower shall have the option of applying the proceeds of any casualty policy up to Two Hundred Fifty Thousand Dollars ($250,000.00) in the aggregate for all losses under all casualty policies in any one (1) year, toward the replacement or repair of destroyed or damaged property; provided that any such replaced or repaired property (i) shall be of equal or like value as the replaced or repaired Collateral and (ii) shall be deemed Collateral in which Bank has been granted a first priority security interest (subject only to Permitted Liens that are permitted pursuant to the terms of this Agreement to have superior priority to Bank’s Lien in this Agreement), and (b) after the occurrence and during the continuance of an Event of Default, all proceeds payable under such casualty policy shall, at the option of Bank, be payable to Bank on account of the Obligations.

(c) At Bank’s request, Borrower shall deliver certified copies of insurance policies and evidence of all premium payments. Each provider of any such insurance required under this Section 6.5 shall agree, by endorsement upon the policy or policies issued by it or by independent instruments furnished to Bank, that it will give Bank thirty (30) days prior written notice before any such policy or policies shall be materially altered or canceled. If Borrower fails to obtain insurance as required under this Section 6.5 or to pay any amount or furnish any required proof of payment to third persons and Bank, Bank may make all or part of such payment or obtain such insurance policies required in this Section 6.5, and take any action under the policies Bank deems prudent.

6.6 Operating Accounts.

(a) Maintain all of its and all of its Subsidiaries’ (excluding Securities Corporation) operating accounts and all excess cash with Bank and Bank’s Affiliates, provided that Australian Subsidiary shall be permitted to maintain accounts with financial institutions other than Bank and Bank’s Affiliates in an aggregate amount (for all such accounts) not to exceed Two Million Dollars ($2,000,000.00) for more

 

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than two (2) consecutive Business Days. In addition to the foregoing, Borrower shall at all times maintain unrestricted cash in accounts in the name of Borrower with Bank, in an amount equal to the lesser of (i) one hundred percent (100.0%) of the Dollar value of Borrower’s consolidated cash, including any Subsidiaries’, Affiliates’, or related entities’ cash, in the aggregate, at all financial institutions, and (ii) one hundred ten percent (110.0%) of the sum of then then-outstanding Obligations of Borrower to Bank. Bank may restrict withdrawals or transfers by or on behalf of Borrower that would violate this Section 6.6(a), regardless of whether an Event of Default exists at such time. In addition to the foregoing, Borrower shall conduct all of its primary banking facilities with Bank and Bank’s Affiliates, including, without limitation, letters of credit and business credit cards.

(b) Provide Bank five (5) days prior written notice before establishing any Collateral Account at or with any bank or financial institution other than Bank or Bank’s Affiliates. For each Collateral Account that Borrower at any time maintains, Borrower shall cause the applicable bank or financial institution (other than Bank) at or with which any Collateral Account is maintained to execute and deliver a Control Agreement or other appropriate instrument with respect to such Collateral Account to perfect Bank’s Lien in such Collateral Account in accordance with the terms hereunder which Control Agreement may not be terminated without the prior written consent of Bank. The provisions of the previous sentence shall not apply to deposit accounts exclusively used for payroll, payroll taxes and other employee wage and benefit payments to or for the benefit of Borrower’s employees and identified to Bank by Borrower as such (the “Excluded Accounts”).

6.7 Protection of Intellectual Property Rights.

(a) (i) Protect, defend and maintain the validity and enforceability of its Intellectual Property material to Borrower’s business; (ii) promptly advise Bank in writing of material infringements or any other event that could reasonably be expected to materially and adversely affect the value of its Intellectual Property material to Borrower’s business; and (iii) not allow any Intellectual Property material to Borrower’s business to be abandoned, forfeited or dedicated to the public without Bank’s written consent.

(b) Provide written notice to Bank within ten (10) days of entering or becoming bound by any Restricted License (other than over-the-counter software that is commercially available to the public). Borrower shall take such steps as Bank requests to obtain the consent of, or waiver by, any person whose consent or waiver is necessary for (i) any Restricted License to be deemed Collateral and for Bank to have a security interest in it that might otherwise be restricted or prohibited by law or by the terms of any such Restricted License, whether now existing or entered into in the future, and (ii) Bank to have the ability in the event of a liquidation of any Collateral to dispose of such Collateral in accordance with Bank’s rights and remedies under this Agreement and the other Loan Documents.

6.8 Litigation Cooperation. From the date hereof and continuing through the termination of this Agreement, make available to Bank, without expense to Bank and upon at least one (1) Business Days’ notice (provided no notice is required if an Event of Default has occurred and is continuing), Borrower and its officers, employees and agents and Borrower’s books and records, to the extent that Bank may deem them reasonably necessary to prosecute or defend any third-party suit or proceeding instituted by or against Bank with respect to any Collateral or relating to Borrower.

6.9 Access to Collateral; Books and Records. Allow Bank, or its agents, at reasonable times, on one (1) Business Days’ notice (provided no notice is required if an Event of Default has occurred and is continuing), to inspect the Collateral and audit and copy Borrower’s Books. Such inspections or audits shall be conducted no more often than once every twelve (12) months unless an Event of Default has occurred and is continuing in which case such inspections and audits shall occur as often as Bank shall determine is necessary. The foregoing inspections and audits shall be at Borrower’s expense, and the charge therefor

 

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shall be One Thousand Dollars ($1,000.00) per person per day (or such higher amount as shall represent Bank’s then-current standard charge for the same), plus reasonable and documented out-of-pocket expenses. In the event Borrower and Bank schedule an audit more than eight (8) days in advance, and Borrower cancels or seeks to reschedule the audit with less than eight (8) days written notice to Bank, then (without limiting any of Bank’s rights or remedies), Borrower shall pay Bank a fee of Two Thousand Dollars ($2,000.00) plus any documented out-of-pocket expenses incurred by Bank to compensate Bank for the anticipated costs and expenses of the cancellation or rescheduling.

6.10 Further Assurances. Execute any further instruments and take further action as Bank reasonably requests to perfect or continue Bank’s Lien in the Collateral or to effect the purposes of this Agreement. Deliver to Bank, within five (5) days after the same are sent or received, copies of all correspondence, reports, documents and other filings with any Governmental Authority regarding compliance with or maintenance of Governmental Approvals or Requirements of Law or that could reasonably be expected to have a material effect on any of the Governmental Approvals or otherwise on the operations of Borrower or any of its Subsidiaries.

6.11 Post-Closing Conditions. Within thirty (30) days after the Effective Date (or such later date as Bank may agree to in writing in its sole and absolute discretion), Borrower shall deliver to Bank evidence satisfactory to Bank that the insurance endorsements required by Section 6.5 hereof are in full force and effect, together with appropriate evidence showing lender loss payable and/or additional insured clauses or endorsements in favor of Bank.

 

  7.

NEGATIVE COVENANTS

Borrower shall not do any of the following without Bank’s prior written consent:

7.1 Dispositions. Convey, sell, lease, transfer, assign, or otherwise dispose of (including, without limitation, pursuant to a Division) (collectively, “Transfer”), or permit any of its Subsidiaries to Transfer, all or any part of its business or property, except for Transfers (a) of Inventory in the ordinary course of business; (b) of worn- out, obsolete or surplus Equipment that is, in the reasonable judgment of Borrower, no longer economically practicable to maintain or useful in the ordinary course of business of Borrower; (c) consisting of Permitted Liens and Permitted Investments; (d) consisting of the sale or issuance of any stock of Borrower permitted under Section 7.2 of this Agreement; (e) consisting of Borrower’s use or transfer of money or Cash Equivalents in a manner that is not prohibited by the terms of this Agreement or the other Loan Documents; and (f) of non-exclusive licenses for the use of the property of Borrower or its Subsidiaries in the ordinary course of business and licenses that could not result in a legal transfer of title of the licensed property but that may be exclusive in respects other than territory and that may be exclusive as to territory only as to discrete geographical areas outside of the United States.

7.2 Changes in Business, Management, Control, or Business Locations. (a) Engage in or permit any of its Subsidiaries to engage in any business other than the businesses currently engaged in by Borrower and such Subsidiary, as applicable, or reasonably related thereto; (b) liquidate or dissolve; (c) fail to provide notice to Bank of any Key Person departing from or ceasing to be employed by Borrower within five (5) Business Days after such Key Person’s departure from Borrower; or (d) permit or suffer any Change in Control.

Borrower shall not, without at least thirty (30) days prior written notice to Bank: (1) add any new offices or business locations, including warehouses (unless each such new office or business location contains less than Two Hundred Fifty Thousand Dollars ($250,000.00) in Borrower’s assets or property) or deliver any portion of the Collateral valued, individually or in the aggregate, in excess of Two Hundred Fifty Thousand Dollars ($250,000.00) to a bailee at a location other than to a bailee and at a location already

 

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disclosed in the Perfection Certificate, (2) change its jurisdiction of organization, (3) change its organizational structure or type, (4) change its legal name, or (5) change any organizational number (if any) assigned by its jurisdiction of organization. If Borrower intends to add any new offices or business locations, including warehouses, containing in excess of Two Hundred Fifty Thousand Dollars ($250,000.00) of Borrower’s assets or property, then Borrower will first receive the written consent of Bank, and the landlord of any such new offices or business locations, including warehouses, shall execute and deliver a landlord consent in form and substance satisfactory to Bank. If Borrower intends to deliver any portion of the Collateral valued, individually or in the aggregate, in excess of Two Hundred Fifty Thousand Dollars ($250,000.00) to a bailee, and Bank and such bailee are not already parties to a bailee agreement governing both the Collateral and the location to which Borrower intends to deliver the Collateral, then Borrower will first receive the written consent of Bank, and such bailee shall execute and deliver a bailee agreement in form and substance satisfactory to Bank.

7.3 Mergers or Acquisitions. Merge or consolidate, or permit any of its Subsidiaries to merge or consolidate, with any other Person, or acquire, or permit any of its Subsidiaries to acquire, all or substantially all of the capital stock or property of another Person (including, without limitation, by the formation of any Subsidiary or pursuant to a Division). A Subsidiary may merge or consolidate into another Subsidiary or into Borrower.

7.4 Indebtedness. Create, incur, assume, or be liable for any Indebtedness, or permit any Subsidiary to do so, other than Permitted Indebtedness.

7.5 Encumbrance. Create, incur, allow, or suffer any Lien on any of its property, or assign or convey any right to receive income, including the sale of any Accounts, or permit any of its Subsidiaries to do so, except for Permitted Liens, permit any Collateral not to be subject to the first priority security interest granted herein, or enter into any agreement, document, instrument or other arrangement (except with or in favor of Bank) with any Person which directly or indirectly prohibits or has the effect of prohibiting Borrower or any Subsidiary from assigning, mortgaging, pledging, granting a security interest in or upon, or encumbering any of Borrower’s or any Subsidiary’s Intellectual Property, except as is otherwise permitted in Section 7.1 hereof and the definition of Permitted Liens herein.

7.6 Maintenance of Collateral Accounts. Maintain any Collateral Account except pursuant to the terms of Section 6.6(b) hereof.

7.7 Distributions; Investments. (a) Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock, provided that (i) Borrower may convert any of its convertible securities into other securities pursuant to the terms of such convertible securities or otherwise in exchange thereof, (ii) Borrower may pay dividends solely in common stock; and (iii) Borrower may repurchase the stock of former employees or consultants pursuant to stock repurchase agreements so long as an Event of Default does not exist at the time of such repurchase and would not exist after giving effect to such repurchase, provided further that the aggregate amount of all such repurchases does not exceed Fifty Thousand Dollars ($50,000.00) in any twelve (12) month period; or (b) directly or indirectly make any Investment (including, without limitation, by the formation of any Subsidiary) other than Permitted Investments, or permit any of its Subsidiaries to do so.

7.8 Transactions with Affiliates. Directly or indirectly enter into or permit to exist any material transaction with any Affiliate of Borrower, except for (a) transactions that are in the ordinary course of Borrower’s business, upon fair and reasonable terms that are no less favorable to Borrower than would be obtained in an arm’s length transaction with a non-affiliated Person, and (b) Subordinated Debt or equity investments by Borrower’s investors in Borrower or its Subsidiaries (including share repurchases permitted by Section 7.7) that do not result in a Change in Control.

 

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7.9 Subordinated Debt. (a) Make or permit any payment on any Subordinated Debt, except under the terms of the subordination, intercreditor, or other similar agreement to which such Subordinated Debt is subject, or (b) amend any provision in any document relating to the Subordinated Debt which would increase the amount thereof, provide for earlier or greater principal, interest, or other payments thereon, or adversely affect the subordination thereof to Obligations owed to Bank.

7.10 Compliance. Become an “investment company” or a company controlled by an “investment company”, under the Investment Company Act of 1940, as amended, or undertake as one of its important activities extending credit to purchase or carry margin stock (as defined in Regulation U of the Board of Governors of the Federal Reserve System), or use the proceeds of any Credit Extension for that purpose; fail to (a) meet the minimum funding requirements of ERISA, (b) prevent a Reportable Event or Prohibited Transaction, as defined in ERISA, from occurring, or (c) comply with the Federal Fair Labor Standards Act, the failure of any of the conditions described in clauses (a) through (c) which could reasonably be expected to have a material adverse effect on Borrower’s business; violate any other law or regulation, if the violation could reasonably be expected to have a material adverse effect on Borrower’s business, or permit any of its Subsidiaries to do so; or withdraw or permit any Subsidiary to withdraw from participation in, permit partial or complete termination of, or permit the occurrence of any other event with respect to, any present pension, profit sharing and deferred compensation plan which could reasonably be expected to result in any liability of Borrower, including any liability to the Pension Benefit Guaranty Corporation or its successors or any other governmental agency.

 

  8.

EVENTS OF DEFAULT

Any one of the following shall constitute an event of default (an “Event of Default”) under this Agreement:

8.1 Payment Default. Borrower fails to (a) make any payment of principal or interest on any Credit Extension when due, or (b) pay any other Obligations within three (3) Business Days after such Obligations are due and payable (which three (3) Business Day cure period shall not apply to payments due on the Term Loan Maturity Date). During the cure period, the failure to make or pay any payment specified under clause (b) hereunder is not an Event of Default (but no Credit Extension will be made during the cure period);

8.2 Covenant Default.

(a) Borrower fails or neglects to perform any obligation in Sections 6.2, 6.4, 6.5, 6.6, 6.7(b), 6.9, or 6.11 or violates any covenant in Section 7; or

(b) Borrower fails or neglects to perform, keep, or observe any other term, provision, condition, covenant or agreement contained in this Agreement or any Loan Documents, and as to any default (other than those specified in clause (a) above) under such other term, provision, condition, covenant or agreement that can be cured, has failed to cure the default within ten (10) days after the occurrence thereof; provided, however, that if the default cannot by its nature be cured within the ten (10) day period or cannot after diligent attempts by Borrower be cured within such ten (10) day period, and such default is likely to be cured within a reasonable time, then Borrower shall have an additional period (which shall not in any case exceed thirty (30) days) to attempt to cure such default, and within such reasonable time period the failure to cure the default shall not be deemed an Event of Default (but no Credit Extensions shall be made during such cure period). Grace and cure periods provided under this Section shall not apply, among other things, to financial covenants or any other covenants set forth in clause (a) above;

8.3 Material Adverse Change. A Material Adverse Change occurs;

 

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8.4 Attachment; Levy; Restraint on Business.

(a) (i) The service of process seeking to attach, by trustee or similar process, any funds of Borrower or of any entity under the control of Borrower (including a Subsidiary), or (ii) a notice of lien or levy is filed against any of Borrower’s assets by any Governmental Authority, and the same under subclauses (i) and (ii) hereof are not, within ten (10) days after the occurrence thereof, discharged or stayed (whether through the posting of a bond or otherwise); provided, however, no Credit Extensions shall be made during any ten (10) day cure period; or

(b) (i) any material portion of Borrower’s assets is attached, seized, levied on, or comes into possession of a trustee or receiver, or (ii) any court order enjoins, restrains, or prevents Borrower from conducting all or any material part of its business;

8.5 Insolvency. (a) Borrower is unable to pay its debts (including trade debts) as they become due or otherwise becomes insolvent; (b) Borrower begins an Insolvency Proceeding; or (c) an Insolvency Proceeding is begun against Borrower and is not dismissed or stayed within forty-five (45) days (but no Credit Extensions shall be made while any of the conditions described in clause (a) exist and/or until any Insolvency Proceeding is dismissed);

8.6 Other Agreements. There is, under any agreement to which Borrower is a party with a third party or parties, (a) any default resulting in a right by such third party or parties, whether or not exercised, to accelerate the maturity of any Indebtedness in an amount individually or in the aggregate in excess of Two Hundred Fifty Thousand Dollars ($250,000.00); or (b) any breach or default by Borrower, the result of which could have a material adverse effect on Borrower’s business;

8.7 Judgments; Penalties. One or more fines, penalties or final judgments, orders or decrees for the payment of money in an amount, individually or in the aggregate, of at least Two Hundred Fifty Thousand Dollars ($250,000.00) (not covered by independent third-party insurance as to which liability has been accepted by such insurance carrier) shall be rendered against Borrower by any Governmental Authority, and the same are not, within ten (10) days after the entry, assessment or issuance thereof, discharged, satisfied, or paid, or after execution thereof, stayed or bonded pending appeal, or such judgments are not discharged prior to the expiration of any such stay (provided that no Credit Extensions will be made prior to the satisfaction, payment, discharge, stay, or bonding of such fine, penalty, judgment, order or decree);

8.8 Misrepresentations. Borrower or any Person acting for Borrower makes any representation, warranty, or other statement now or later in this Agreement, any Loan Document or in any writing delivered to Bank or to induce Bank to enter this Agreement or any Loan Document, and such representation, warranty, or other statement is incorrect in any material respect when made;

8.9 Subordinated Debt. Any document, instrument, or agreement evidencing any Subordinated Debt shall for any reason be revoked or invalidated or otherwise cease to be in full force and effect, any Person shall be in breach thereof or contest in any manner the validity or enforceability thereof or deny that it has any further liability or obligation thereunder, or the Obligations shall for any reason be subordinated or shall not have the priority contemplated by this Agreement; or

8.10 Governmental Approvals. Any Governmental Approval shall have been (a) revoked, rescinded, suspended, modified in an adverse manner or not renewed in the ordinary course for a full term or (b) subject to any decision by a Governmental Authority that designates a hearing with respect to any applications for renewal of any of such Governmental Approval or that could result in the Governmental Authority taking any of the actions described in clause (a) above, and such decision or such revocation,

 

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rescission, suspension, modification or nonrenewal (i) causes, or could reasonably be expected to cause, a Material Adverse Change, or (ii) adversely affects the legal qualifications of Borrower or any of its Subsidiaries to hold such Governmental Approval in any applicable jurisdiction and such revocation, rescission, suspension, modification or non-renewal could reasonably be expected to affect the status of or legal qualifications of Borrower or any of its Subsidiaries to hold any Governmental Approval in any other jurisdiction.

9. BANK’S RIGHTS AND REMEDIES

9.1 Rights and Remedies. Upon the occurrence and during the continuance of an Event of Default, Bank may, without notice or demand, do any or all of the following to the extent not prohibited by applicable law:

(a) declare all Obligations immediately due and payable (but if an Event of Default described in Section 8.5 occurs all Obligations are immediately due and payable without any action by Bank);

(b) stop advancing money or extending credit for Borrower’s benefit under this Agreement or under any other agreement between Borrower and Bank;

(c) demand that Borrower (i) deposit cash with Bank in an amount equal to at least (x) one hundred five percent (105.0%) of the Dollar Equivalent of the aggregate face amount of all Letters of Credit denominated in Dollars remaining undrawn, and (y) one hundred ten percent (110.0%) of the Dollar Equivalent of the aggregate face amount of all Letters of Credit denominated in a Foreign Currency remaining undrawn (plus, in each case, all interest, fees, and costs due or to become due in connection therewith (as estimated by Bank in its good faith business judgment)), to secure all of the Obligations relating to such Letters of Credit, as collateral security for the repayment of any future drawings under such Letters of Credit, and Borrower shall forthwith deposit and pay such amounts, and (ii) pay in advance all letter of credit fees scheduled to be paid or payable over the remaining term of any Letters of Credit;

(d) terminate any FX Contracts;

(e) verify the amount of, demand payment of and performance under, and collect any Accounts and General Intangibles, settle or adjust disputes and claims directly with Account Debtors for amounts on terms and in any order that Bank considers advisable, and notify any Person owing Borrower money of Bank’s security interest in such funds;

(f) make any payments and do any acts it considers necessary or reasonable to protect the Collateral and/or its security interest in the Collateral. Borrower shall assemble the Collateral if Bank requests and make it available as Bank designates at a location reasonably convenient to Bank and Borrower. Bank may peaceably enter premises where the Collateral is located, take and maintain possession of any part of the Collateral, and pay, purchase, contest, or compromise any Lien which appears to be prior or superior to its security interest and pay all expenses incurred. Borrower grants Bank a license to enter and occupy any of its premises, without charge by Borrower, to exercise any of Bank’s rights or remedies;

(g) apply to the Obligations (i) any balances and deposits of Borrower it holds, or (ii) any amount held by Bank owing to or for the credit or the account of Borrower;

(h) ship, reclaim, recover, store, finish, maintain, repair, prepare for sale, advertise for sale, and sell the Collateral. Bank is hereby granted a non-exclusive, royalty-free license or other right to use, without charge, Borrower’s labels, Patents, Copyrights, mask works, rights of use of any name, trade

 

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secrets, trade names, Trademarks, and advertising matter, or any similar property as it pertains to the Collateral, in completing production of, advertising for sale, and selling any Collateral and, in connection with Bank’s exercise of its rights under this Section, Borrower’s rights under all licenses and all franchise agreements inure to Bank’s benefit;

(i) place a “hold” on any account maintained with Bank and/or deliver a notice of exclusive control, any entitlement order, or other directions or instructions pursuant to any Control Agreement or similar agreements providing control of any Collateral;

(j) demand and receive possession of Borrower’s Books; and

(k) exercise all rights and remedies available to Bank under the Loan Documents or at law or equity, including all remedies provided under the Code (including disposal of the Collateral pursuant to the terms thereof).

9.2 Power of Attorney. Borrower hereby irrevocably appoints Bank as its lawful attorney-in-fact, exercisable upon the occurrence and during the continuance of an Event of Default, to: (a) endorse Borrower’s name on any checks or other forms of payment or security; (b) sign Borrower’s name on any invoice or bill of lading for any Account or drafts against Account Debtors; (c) settle and adjust disputes and claims about the Accounts directly with Account Debtors, for amounts and on terms Bank determines reasonable; (d) make, settle, and adjust all claims under Borrower’s insurance policies; (e) pay, contest or settle any Lien, charge, encumbrance, security interest, and adverse claim in or to the Collateral, or any judgment based thereon, or otherwise take any action to terminate or discharge the same; and (f) transfer the Collateral into the name of Bank or a third party as the Code permits. Borrower hereby appoints Bank as its lawful attorney-in-fact to sign Borrower’s name on any documents necessary to perfect or continue the perfection of Bank’s security interest in the Collateral regardless of whether an Event of Default has occurred until all Obligations (other than inchoate indemnity obligations) have been satisfied in full and Bank is under no further obligation to make Credit Extensions hereunder. Bank’s foregoing appointment as Borrower’s attorney in fact, and all of Bank’s rights and powers, coupled with an interest, are irrevocable until all Obligations (other than inchoate indemnity obligations) have been fully repaid and performed and Bank’s obligation to provide Credit Extensions terminates.

9.3 Protective Payments. If Borrower fails to obtain the insurance called for by Section 6.5 or fails to pay any premium thereon or fails to pay any other amount which Borrower is obligated to pay under this Agreement or any other Loan Document or which may be required to preserve the Collateral, Bank may obtain such insurance or make such payment, and all amounts so paid by Bank are Bank Expenses and immediately due and payable, bearing interest at the then highest rate applicable to the Obligations, and secured by the Collateral. Bank will make reasonable efforts to provide Borrower with notice of Bank obtaining such insurance at the time it is obtained or within a reasonable time thereafter. No payments by Bank are deemed an agreement to make similar payments in the future or Bank’s waiver of any Event of Default.

9.4 Application of Payments and Proceeds Upon Default. If an Event of Default has occurred and is continuing, Bank shall have the right to apply in any order any funds in its possession, whether from Borrower account balances, payments, proceeds realized as the result of any collection of Accounts or other disposition of the Collateral, or otherwise, to the Obligations. Bank shall pay any surplus to Borrower by credit to the Designated Deposit Account or to other Persons legally entitled thereto; Borrower shall remain liable to Bank for any deficiency. If Bank, directly or indirectly, enters into a deferred payment or other credit transaction with any purchaser at any sale of Collateral, Bank shall have the option, exercisable at any time, of either reducing the Obligations by the principal amount of the purchase price or deferring the reduction of the Obligations until the actual receipt by Bank of cash therefor.

 

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9.5 Bank’s Liability for Collateral. So long as Bank complies with applicable law and reasonable banking practices regarding the safekeeping of the Collateral in the possession or under the control of Bank, Bank shall not be liable or responsible for: (a) the safekeeping of the Collateral; (b) any loss or damage to the Collateral; (c) any diminution in the value of the Collateral; or (d) any act or default of any carrier, warehouseman, bailee, or other Person. Borrower bears all risk of loss, damage or destruction of the Collateral.

9.6 No Waiver; Remedies Cumulative. Bank’s failure, at any time or times, to require strict performance by Borrower of any provision of this Agreement or any other Loan Document shall not waive, affect, or diminish any right of Bank thereafter to demand strict performance and compliance herewith or therewith. No waiver hereunder shall be effective unless signed by the party granting the waiver and then is only effective for the specific instance and purpose for which it is given. Bank’s rights and remedies under this Agreement and the other Loan Documents are cumulative. Bank has all rights and remedies provided under the Code, by law, or in equity. Bank’s exercise of one right or remedy is not an election and shall not preclude Bank from exercising any other remedy under this Agreement or other remedy available at law or in equity, and Bank’s waiver of any Event of Default is not a continuing waiver. Bank’s delay in exercising any remedy is not a waiver, election, or acquiescence.

9.7 Demand Waiver. Borrower waives demand, notice of default or dishonor, notice of payment and nonpayment, notice of any default, nonpayment at maturity, release, compromise, settlement, extension, or renewal of accounts, documents, instruments, chattel paper, and guarantees held by Bank on which Borrower is liable.

 

  10.

NOTICES

All notices, consents, requests, approvals, demands, or other communication by any party to this Agreement or any other Loan Document must be in writing and shall be deemed to have been validly served, given, or delivered: (a) upon the earlier of actual receipt and three (3) Business Days after deposit in the U.S. mail, first class, registered or certified mail return receipt requested, with proper postage prepaid; (b) upon transmission, when sent by electronic mail or facsimile transmission; (c) one (1) Business Day after deposit with a reputable overnight courier with all charges prepaid; or (d) when delivered, if hand-delivered by messenger, all of which shall be addressed to the party to be notified and sent to the address, facsimile number, or email address indicated below. Bank or Borrower may change its mailing or electronic mail address or facsimile number by giving the other party written notice thereof in accordance with the terms of this Section 10.

 

                       If to Borrower:   

Q32 Bio Inc.

One Broadway, 11th Floor

Cambridge, MA 02142

Attn: Maria Marzilli

Email: [*****************]

  with a copy to:   

Goodwin Procter LLP

100 Northern Avenue

Boston, Massachusetts 02210

Attn: Mark D. Smith

Email: marksmith@goodwinlaw.com

  If to Bank:   

Silicon Valley Bank

275 Grove Street, Suite 2-200

Newton, Massachusetts 02466

Attn: Lauren Cole

Email: LCole@svb.com

 

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                       with a copy to:   

Morrison & Foerster LLP

200 Clarendon Street

Boston, Massachusetts 02116

Attn: David A. Ephraim, Esquire

Email: DEphraim@mofo.com

 

  11.

CHOICE OF LAW, VENUE AND JURY TRIAL WAIVER

Except as otherwise expressly provided in any of the Loan Documents, Massachusetts law governs the Loan Documents without regard to principles of conflicts of law. Borrower and Bank each submit to the exclusive jurisdiction of the State and Federal courts in Boston, Massachusetts; provided, however, that nothing in this Agreement shall be deemed to operate to preclude Bank from bringing suit or taking other legal action in any other jurisdiction to realize on the Collateral or any other security for the Obligations, or to enforce a judgment or other court order in favor of Bank. Borrower expressly submits and consents in advance to such jurisdiction in any action or suit commenced in any such court, and Borrower hereby waives any objection that it may have based upon lack of personal jurisdiction, improper venue, or forum non conveniens and hereby consents to the granting of such legal or equitable relief as is deemed appropriate by such court. Borrower hereby waives personal service of the summons, complaints, and other process issued in such action or suit and agrees that service of such summons, complaints, and other process may be made by registered or certified mail addressed to Borrower at the address set forth in, or subsequently provided by Borrower in accordance with, Section 10 of this Agreement and that service so made shall be deemed completed upon the earlier to occur of Borrower’s actual receipt thereof or three (3) days after deposit in the U.S. mails, proper postage prepaid.

TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, BORROWER AND BANK EACH WAIVE THEIR RIGHT TO A JURY TRIAL OF ANY CLAIM OR CAUSE OF ACTION ARISING OUT OF OR BASED UPON THIS AGREEMENT, THE LOAN DOCUMENTS OR ANY CONTEMPLATED TRANSACTION, INCLUDING CONTRACT, TORT, BREACH OF DUTY AND ALL OTHER CLAIMS. THIS WAIVER IS A MATERIAL INDUCEMENT FOR BOTH PARTIES TO ENTER INTO THIS AGREEMENT. EACH PARTY HAS REVIEWED THIS WAIVER WITH ITS COUNSEL.

This Section 11 shall survive the termination of this Agreement.

 

  12.

GENERAL PROVISIONS

12.1 Termination Prior to Term Loan Maturity Date; Survival. All covenants, representations and warranties made in this Agreement shall continue in full force until this Agreement has terminated pursuant to its terms and all Obligations (other than inchoate indemnity obligations, any other obligations which, by their terms, are to survive the termination of this Agreement) have been satisfied. So long as Borrower has satisfied the Obligations (other than inchoate indemnity obligations and, any other obligations which, by their terms, are to survive the termination of this Agreement, and any Obligations under Bank Services Agreements that are cash collateralized in accordance with Section 4.1 of this Agreement), this Agreement may be terminated prior to the Term Loan Maturity Date by Borrower, effective three (3) Business Days after written notice of termination is given to Bank. Those obligations that are expressly specified in this Agreement as surviving this Agreement’s termination shall continue to survive notwithstanding this Agreement’s termination.

 

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12.2 Successors and Assigns. This Agreement binds and is for the benefit of the successors and permitted assigns of each party. Borrower may not assign this Agreement or any rights or obligations under it without Bank’s prior written consent (which may be granted or withheld in Bank’s discretion). Bank has the right, without the consent of or notice to Borrower, to sell, transfer, assign, negotiate, or grant participation in all or any part of, or any interest in, Bank’s obligations, rights, and benefits under this Agreement and the other Loan Documents (other than the Warrant, as to which assignment, transfer and other such actions are governed by the terms thereof). Notwithstanding the foregoing, prior to the occurrence of an Event of Default, Bank shall not assign any interest in the Loan Documents to any person who is (a) a direct competitor of Borrower, or (b) a vulture fund or distressed debt fund.

12.3 Indemnification. Borrower agrees to indemnify, defend and hold Bank and its directors, officers, employees, agents, attorneys, or any other Person affiliated with or representing Bank (each, an “Indemnified Person”) harmless against: (i) all obligations, demands, claims, and liabilities (collectively, “Claims”) claimed or asserted by any other party in connection with the transactions contemplated by the Loan Documents; and (ii) all losses or expenses (including Bank Expenses) in any way suffered, incurred, or paid by such Indemnified Person as a result of, following from, consequential to, or arising from transactions between Bank and Borrower (including reasonable and documented attorneys’ fees and out-of-pocket expenses), except for Claims and/or losses directly caused by such Indemnified Person’s gross negligence or willful misconduct.

This Section 12.3 shall survive until all statutes of limitation with respect to the Claims, losses, and expenses for which indemnity is given shall have run.

12.4 Time of Essence. Time is of the essence for the performance of all Obligations in this Agreement.

12.5 Severability of Provisions. Each provision of this Agreement is severable from every other provision in determining the enforceability of any provision.

12.6 Correction of Loan Documents. Bank may correct patent errors and fill in any blanks in the Loan Documents consistent with the agreement of the parties, so long as Bank provides Borrower with written notice of such correction and allows Borrower at least ten (10) days to object to such correction. In the event of such objection, such correction shall not be made except by an amendment signed by both Bank and Borrower.

12.7 Amendments in Writing; Waiver; Integration. No purported amendment or modification of any Loan Document, or waiver, discharge or termination of any obligation under any Loan Document, shall be enforceable or admissible unless, and only to the extent, expressly set forth in a writing signed by the party against which enforcement or admission is sought. Without limiting the generality of the foregoing, no oral promise or statement, nor any action, inaction, delay, failure to require performance or course of conduct shall operate as, or evidence, an amendment, supplement or waiver or have any other effect on any Loan Document. Any waiver granted shall be limited to the specific circumstance expressly described in it, and shall not apply to any subsequent or other circumstance, whether similar or dissimilar, or give rise to, or evidence, any obligation or commitment to grant any further waiver. The Loan Documents represent the entire agreement about this subject matter and supersede prior negotiations or agreements. All prior agreements, understandings, representations, warranties, and negotiations between the parties about the subject matter of the Loan Documents merge into the Loan Documents.

12.8 Counterparts. This Agreement may be executed in any number of counterparts and by different parties on separate counterparts, each of which, when executed and delivered, is an original, and all taken together, constitute one Agreement.

 

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12.9 Confidentiality. In handling any confidential information, Bank shall exercise the same degree of care that it exercises for its own proprietary information, but disclosure of information may be made: (a) to Bank’s Subsidiaries or Affiliates (such Subsidiaries and Affiliates, together with Bank, collectively, “Bank Entities”); (b) to prospective transferees or purchasers of any interest in the Credit Extensions (provided, however, Bank shall use its best efforts to obtain any prospective transferee’s or purchaser’s agreement to the terms of this provision); (c) as required by law, regulation, subpoena, or other order; (d) to Bank’s regulators or as otherwise required in connection with Bank’s examination or audit; (e) as Bank considers appropriate in exercising remedies under the Loan Documents; and (f) to third-party service providers of Bank so long as such service providers have executed a confidentiality agreement with Bank with terms no less restrictive than those contained herein. Confidential information does not include information that is either: (i) in the public domain or in Bank’s possession when disclosed to Bank, or becomes part of the public domain (other than as a result of its disclosure by Bank in violation of this Agreement) after disclosure to Bank; or (ii) disclosed to Bank by a third party, if Bank does not know that the third party is prohibited from disclosing the information.

Bank Entities may use anonymous forms of confidential information for aggregate datasets, for analyses or reporting, and for any other uses not expressly prohibited in writing by Borrower. The provisions of the immediately preceding sentence shall survive termination of this Agreement.

12.10 Right of Set Off. Borrower hereby grants to Bank, a Lien, security interest and right of set off as security for all Obligations to Bank, whether now existing or hereafter arising upon and against all deposits, credits, collateral and property, now or hereafter in the possession, custody, safekeeping or control of Bank or any entity under the control of Bank (including a Bank subsidiary) or in transit to any of them. At any time after the occurrence and during the continuance of an Event of Default, without demand or notice, Bank may set off the same or any part thereof and apply the same to any Obligation of Borrower then due and regardless of the adequacy of any other collateral securing the Obligations. ANY AND ALL RIGHTS TO REQUIRE BANK TO EXERCISE ITS RIGHTS OR REMEDIES WITH RESPECT TO ANY OTHER COLLATERAL WHICH SECURES THE OBLIGATIONS, PRIOR TO EXERCISING ITS RIGHT OF SETOFF WITH RESPECT TO SUCH DEPOSITS, CREDITS OR OTHER PROPERTY OF BORROWER ARE HEREBY KNOWINGLY, VOLUNTARILY AND IRREVOCABLY WAIVED.

12.11 Electronic Execution of Documents. The words “execution,” “signed,” “signature” and words of like import in any Loan Document shall be deemed to include electronic signatures or the keeping of records in electronic form, each of which shall be of the same legal effect, validity and enforceability as a manually executed signature or the use of a paper-based recordkeeping systems, as the case may be, to the extent and as provided for in any applicable law, including, without limitation, any state law based on the Uniform Electronic Transactions Act.

12.12 Captions. The headings used in this Agreement are for convenience only and shall not affect the interpretation of this Agreement.

12.13 Construction of Agreement. The parties mutually acknowledge that they and their attorneys have participated in the preparation and negotiation of this Agreement. In cases of uncertainty this Agreement shall be construed without regard to which of the parties caused the uncertainty to exist.

12.14 Relationship. The relationship of the parties to this Agreement is determined solely by the provisions of this Agreement. The parties do not intend to create any agency, partnership, joint venture, trust, fiduciary or other relationship with duties or incidents different from those of parties to an arm’s-length contract.

 

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12.15 Third Parties. Nothing in this Agreement, whether express or implied, is intended to: (a) confer any benefits, rights or remedies under or by reason of this Agreement on any persons other than the express parties to it and their respective permitted successors and assigns; (b) relieve or discharge the obligation or liability of any person not an express party to this Agreement; or (c) give any person not an express party to this Agreement any right of subrogation or action against any party to this Agreement.

 

  13.

DEFINITIONS

13.1 Definitions. As used in the Loan Documents, the word “shall” is mandatory, the word “may” is permissive, the word “or” is not exclusive, the words “includes” and “including” are not limiting, the singular includes the plural, and numbers denoting amounts that are set off in brackets are negative. As used in this Agreement, the following capitalized terms have the following meanings:

“Account” is any “account” as defined in the Code with such additions to such term as may hereafter be made, and includes, without limitation, all accounts receivable and other sums owing to Borrower.

“Account Debtor” is any “account debtor” as defined in the Code with such additions to such term as may hereafter be made.

“Affiliate” is, with respect to any Person, each other Person that owns or controls directly or indirectly the Person, any Person that controls or is controlled by or is under common control with the Person, and each of that Person’s senior executive officers, directors, partners and, for any Person that is a limited liability company, that Person’s managers and members.

“Agreement” is defined in the preamble hereof.

“Australian Subsidiary” is Q32 Bio Australia Pty Ltd, an entity organized under the laws of Australia and a Subsidiary of Borrower.

“Authorized Signer” is any individual listed in Borrower’s Borrowing Resolutions who is authorized to execute the Loan Documents, including making (and executing if applicable) any Credit Extension request, on behalf of Borrower.

“Bank” is defined in the preamble hereof.

“Bank Entities” is defined in Section 12.9.

“Bank Expenses” are all audit fees and expenses, costs, and expenses (including reasonable and documented attorneys’ fees and out-of-pocket expenses) for preparing, amending, negotiating, administering, defending and enforcing the Loan Documents (including, without limitation, those incurred in connection with appeals or Insolvency Proceedings) or otherwise incurred with respect to Borrower.

“Bank Services” are any products, credit services, and/or financial accommodations previously, now, or hereafter provided to Borrower or any of its Subsidiaries by Bank or any Bank Affiliate, including, without limitation, any letters of credit, cash management services (including, without limitation, merchant services, direct deposit of payroll, business credit cards, and check cashing services), interest rate swap arrangements, and foreign exchange services as any such products or services may be identified in Bank’s various agreements related thereto (each, a “Bank Services Agreement”).

“Bank Services Agreement” is defined in the definition of Bank Services.

 

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“Board” means Borrower’s board of directors.

“Borrower” is defined in the preamble hereof.

“Borrower’s Books” are all Borrower’s books and records including ledgers, federal and state tax returns, records regarding Borrower’s assets or liabilities, the Collateral, business operations or financial condition, and all computer programs or storage or any equipment containing such information.

“Borrowing Resolutions” are, with respect to any Person, those resolutions adopted by such Person’s board of directors (and, if required under the terms of such Person’s Operating Documents, stockholders) and delivered by such Person to Bank approving the Loan Documents to which such Person is a party and the transactions contemplated thereby, together with a certificate executed by its secretary on behalf of such Person certifying (a) such Person has the authority to execute, deliver, and perform its obligations under each of the Loan Documents to which it is a party, (b) that set forth as a part of or attached as an exhibit to such certificate is a true, correct, and complete copy of the resolutions then in full force and effect authorizing and ratifying the execution, delivery, and performance by such Person of the Loan Documents to which it is a party, (c) the name(s) of the Person(s) authorized to execute the Loan Documents, including making (and executing if applicable) any Credit Extension request, on behalf of such Person, together with a sample of the true signature(s) of such Person(s), and (d) that Bank may conclusively rely on such certificate unless and until such Person shall have delivered to Bank a further certificate canceling or amending such prior certificate.

“Business Day” is any day that is not a Saturday, Sunday or a day on which Bank is closed, and if any determination of a “Business Day” shall relate to an FX Contract, the term “Business Day” shall mean a day on which dealings are carried on in the country of settlement of the Foreign Currency.

“Cash Equivalents” means (a) marketable direct obligations issued or unconditionally guaranteed by the United States or any agency or any State thereof having maturities of not more than one (1) year from the date of acquisition; (b) commercial paper maturing no more than one (1) year after its creation and having the highest rating from either Standard & Poor’s Ratings Group or Moody’s Investors Service, Inc.; (c) Bank’s certificates of deposit issued maturing no more than one (1) year after issue; and (d) money market funds at least ninety-five percent (95.0%) of the assets of which constitute Cash Equivalents of the kinds described in clauses (a) through (c) of this definition.

“Change in Control” means (a) at any time, any “person” or “group” (as such terms are used in Sections 13(d) and 14(d) of the Exchange Act) shall become, or obtain rights (whether by means of warrants, options or otherwise) to become, the “beneficial owner” (as defined in Rules 13(d)-3 and 13(d)-5 under the Exchange Act), directly or indirectly, of forty percent (40.0%) or more of the ordinary voting power for the election of directors of Borrower (determined on a fully diluted basis) other than by the sale of Borrower’s equity securities in a public offering or to venture capital or private equity investors so long as Borrower identifies to Bank the venture capital or private equity investors at least seven (7) Business Days prior to the closing of the transaction and provides to Bank a description of the material terms of the transaction; (b) during any period of twelve (12) consecutive months, a majority of the members of the Board or other equivalent governing body of Borrower cease to be composed of individuals (i) who were members of that board or equivalent governing body on the first day of such period, (ii) whose election or nomination to that board or equivalent governing body was approved by individuals referred to in clause (i) above constituting at the time of such election or nomination at least a majority of that board or equivalent governing body or (iii) whose election or nomination to that board or other equivalent governing body was approved by individuals referred to in clauses (i) and (ii) above constituting at the time of such election or nomination at least a majority of that board or equivalent governing body; or (c) at any time, Borrower shall cease to own and control, of record and beneficially, directly or indirectly, one hundred percent (100.0%) of each class of outstanding capital stock of each Subsidiary of Borrower free and clear of all Liens (except Liens created by this Agreement).

 

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“Claims” is defined in Section 12.3.

“Code” is the Uniform Commercial Code, as the same may, from time to time, be enacted and in effect in the Commonwealth of Massachusetts; provided, that, to the extent that the Code is used to define any term herein or in any Loan Document and such term is defined differently in different Articles or Divisions of the Code, the definition of such term contained in Article or Division 9 shall govern; provided further, that in the event that, by reason of mandatory provisions of law, any or all of the attachment, perfection, or priority of, or remedies with respect to, Bank’s Lien on any Collateral is governed by the Uniform Commercial Code in effect in a jurisdiction other than the Commonwealth of Massachusetts, the term “Code” shall mean the Uniform Commercial Code as enacted and in effect in such other jurisdiction solely for purposes of the provisions thereof relating to such attachment, perfection, priority, or remedies and for purposes of definitions relating to such provisions.

“Collateral” is any and all properties, rights and assets of Borrower described on Exhibit A.

“Collateral Account” is any Deposit Account, Securities Account, or Commodity Account.

“Commodity Account” is any “commodity account” as defined in the Code with such additions to such term as may hereafter be made.

“Compliance Statement” is that certain statement in the form attached hereto as Exhibit B.

“Contingent Obligation” is, for any Person, any direct or indirect liability, contingent or not, of that Person for (a) any indebtedness, lease, dividend, letter of credit or other obligation of another such as an obligation, in each case, directly or indirectly guaranteed, endorsed, co-made, discounted or sold with recourse by that Person, or for which that Person is directly or indirectly liable; (b) any obligations for undrawn letters of credit for the account of that Person; and (c) all obligations from any interest rate, currency or commodity swap agreement, interest rate cap or collar agreement, or other agreement or arrangement designated to protect a Person against fluctuation in interest rates, currency exchange rates or commodity prices; but “Contingent Obligation” does not include endorsements in the ordinary course of business. The amount of a Contingent Obligation is the stated or determined amount of the primary obligation for which the Contingent Obligation is made or, if not determinable, the maximum reasonably anticipated liability for it determined by the Person in good faith; but the amount may not exceed the maximum of the obligations under any guarantee or other support arrangement.

“Control Agreement” is any control agreement entered into among the depository institution at which Borrower maintains a Deposit Account or the securities intermediary or commodity intermediary at which Borrower maintains a Securities Account or a Commodity Account, Borrower, and Bank pursuant to which Bank obtains control (within the meaning of the Code) over such Deposit Account, Securities Account, or Commodity Account.

“Copyrights” are any and all copyright rights, copyright applications, copyright registrations and like protections in each work of authorship and derivative work thereof, whether published or unpublished and whether or not the same also constitutes a trade secret.

“Credit Extension” is any Term Loan Advance or any other extension of credit by Bank for Borrower’s benefit.

 

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“Default Rate” is defined in Section 2.2(b).

“Deposit Account” is any “deposit account” as defined in the Code with such additions to such term as may hereafter be made.

“Designated Deposit Account” is the account number ending 718 (last three digits) maintained by Borrower with Bank (provided, however, if no such account number is included, then the Designated Deposit Account shall be any deposit account of Borrower maintained with Bank as chosen by Bank).

“Division” means, in reference to any Person which is an entity, the division of such Person into two (2) or more separate Persons, with the dividing Person either continuing or terminating its existence as part of such division, including, without limitation, as contemplated under Section 18-217 of the Delaware Limited Liability Company Act for limited liability companies formed under Delaware law, or any analogous action taken pursuant to any other applicable law with respect to any corporation, limited liability company, partnership or other entity.

“Dollars”, “dollars” or use of the sign “$” means only lawful money of the United States and not any other currency, regardless of whether that currency uses the “$” sign to denote its currency or may be readily converted into lawful money of the United States.

“Dollar Equivalent” is, at any time, (a) with respect to any amount denominated in Dollars, such amount, and (b) with respect to any amount denominated in a Foreign Currency, the equivalent amount therefor in Dollars as determined by Bank at such time on the basis of the then-prevailing rate of exchange in San Francisco, California, for sales of the Foreign Currency for transfer to the country issuing such Foreign Currency.

“Draw Period 1” is the period of time commencing upon the Effective Date and continuing through the earlier to occur of (a) December 31, 2021, or (b) an Event of Default.

“Draw Period 2” is the period of time commencing upon the occurrence of Performance Milestone I and continuing through the earlier to occur of (a) January 31, 2022, or (b) an Event of Default.

“Draw Period 3” is the period of time commencing upon the occurrence of (i) Performance Milestone I, which, for the purposes of Draw Period 3 only, may be achieved on or prior to April 30, 2022, and (ii) Performance Milestone II and continuing through the earlier to occur of (a) April 30, 2022, or (b) an Event of Default.

“Effective Date” is defined in the preamble hereof.

“Equipment” is all “equipment” as defined in the Code with such additions to such term as may hereafter be made, and includes without limitation all machinery, fixtures, goods, vehicles (including motor vehicles and trailers), and any interest in any of the foregoing.

“ERISA” is the Employee Retirement Income Security Act of 1974, as amended and its regulations.

“Event of Default” is defined in Section 8.

“Exchange Act” is the Securities Exchange Act of 1934, as amended.

“Excluded Accounts” is defined in Section 6.6(b).

 

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“FDA” shall mean the United States Food and Drug Administration, and any successor thereto.

“Final Payment” is a payment (in addition to and not in substitution for the regular monthly payments of principal plus accrued interest) equal to the aggregate original principal amount of the Term Loan Advances extended by Bank to Borrower hereunder, multiplied by two percent (2.0%), due on the earliest to occur of (a) the Term Loan Maturity Date, (b) the payment in full of the Term Loan Advances, (c) as required by Section 2.1.1(d) or Section 2.1.1(e), or (d) the termination of this Agreement.

“Financial Statement Repository” is NECreditSolutions@svb.com or such other means of collecting information approved and designated by Bank after providing notice thereof to Borrower from time to time.

“Foreign Currency” means lawful money of a country other than the United States.

“Funding Date” is any date on which a Credit Extension is made to or for the account of Borrower which shall be a Business Day.

“FX Contract” is any foreign exchange contract by and between Borrower and Bank under which Borrower commits to purchase from or sell to Bank a specific amount of Foreign Currency on a specified date.

“GAAP” is generally accepted accounting principles set forth in the opinions and pronouncements of the Accounting Principles Board of the American Institute of Certified Public Accountants and statements and pronouncements of the Financial Accounting Standards Board or in such other statements by such other Person as may be approved by a significant segment of the accounting profession, which are applicable to the circumstances as of the date of determination.

“General Intangibles” is all “general intangibles” as defined in the Code in effect on the date hereof with such additions to such term as may hereafter be made, and includes without limitation, all Intellectual Property, claims, income and other tax refunds, security and other deposits, payment intangibles, contract rights, options to purchase or sell real or personal property, rights in all litigation presently or hereafter pending (whether in contract, tort or otherwise), insurance policies (including without limitation key man, property damage, and business interruption insurance), payments of insurance and rights to payment of any kind.

“Good Faith Deposit” is defined in Section 2.3(c).

“Governmental Approval” is any consent, authorization, approval, order, license, franchise, permit, certificate, accreditation, registration, filing or notice, of, issued by, from or to, or other act by or in respect of, any Governmental Authority.

“Governmental Authority” is any nation or government, any state or other political subdivision thereof, any agency, authority, instrumentality, regulatory body, court, central bank or other entity exercising executive, legislative, judicial, taxing, regulatory or administrative functions of or pertaining to government, any securities exchange and any self-regulatory organization.

“Indebtedness” is (a) indebtedness for borrowed money or the deferred price of property or services, such as reimbursement and other obligations for surety bonds and letters of credit, (b) obligations evidenced by notes, bonds, debentures or similar instruments, (c) capital lease obligations, and (d) Contingent Obligations.

 

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“Indemnified Person” is defined in Section 12.3.

“Insolvency Proceeding” is any proceeding by or against any Person under the United States Bankruptcy Code, or any other bankruptcy or insolvency law, including assignments for the benefit of creditors, compositions, extensions generally with its creditors, or proceedings seeking reorganization, arrangement, or other relief.

“Intellectual Property” means, with respect to any Person, all of such Person’s right, title, and interest in and to the following:

(a) its Copyrights, Trademarks and Patents;

(b) any and all trade secrets and trade secret rights, including, without limitation, any rights to unpatented inventions, know-how, and operating manuals;

(c) any and all source code;

(d) any and all design rights which may be available to such Person;

(e) any and all claims for damages by way of past, present and future infringement of any of the foregoing, with the right, but not the obligation, to sue for and collect such damages for said use or infringement of the Intellectual Property rights identified above; and

(f) all amendments, renewals and extensions of any of the Copyrights, Trademarks or Patents.

“Interest Only Extension Event” occurs if and when (if ever) Bank confirms in writing that it has received evidence, on or prior to April 30, 2022, of evidence satisfactory to Bank in its sole and absolute discretion, that Borrower has achieved both (a) Performance Milestone I and (b) Performance Milestone II.

“Inventory” is all “inventory” as defined in the Code in effect on the date hereof with such additions to such term as may hereafter be made, and includes without limitation all merchandise, raw materials, parts, supplies, packing and shipping materials, work in process and finished products, including without limitation such inventory as is temporarily out of Borrower’s custody or possession or in transit and including any returned goods and any documents of title representing any of the above.

“Investment” is any beneficial ownership interest in any Person (including stock, partnership interest or other securities), and any loan, advance or capital contribution to any Person.

“Key Person” is each of Borrower’s (a) Chief Executive Officer, who is Michael Broxson as of the Effective Date, as of the Effective Date, and (b) Head of Corporate Development, who is Maria Marzilli.

“Letter of Credit” is a standby or commercial letter of credit issued by Bank upon request of Borrower based upon an application, guarantee, indemnity, or similar agreement.

“Lien” is a claim, mortgage, deed of trust, levy, charge, pledge, security interest or other encumbrance of any kind, whether voluntarily incurred or arising by operation of law or otherwise against any property.

 

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“Loan Documents” are, collectively, this Agreement and any schedules, exhibits, certificates, notices, and any other documents related to this Agreement, the Warrant, the Perfection Certificate, the Stock Pledge Agreement, any Control Agreement, any Bank Services Agreement, any subordination agreement, any note, or notes or guaranties executed by Borrower, and any other present or future agreement by Borrower with or for the benefit of Bank in connection with this Agreement or Bank Services, all as amended, restated, or otherwise modified.

“Material Adverse Change” is (a) a material impairment in the perfection or priority of Bank’s Lien in the Collateral or in the value of such Collateral; (b) a material adverse change in the business, operations, or condition (financial or otherwise) of Borrower; or (c) a material impairment of the prospect of repayment of any portion of the Obligations when due. In determining whether a “Material Adverse Change” has occurred under clause (b) or (c) above, Bank’s primary, though not sole, consideration will be whether Borrower has or will have sufficient cash resources to repay the Obligations as and when due. Bank recognizes that, as a pre-profit company, Borrower’s cash resources will decline over time, and Borrower will periodically require additional infusions of equity capital. The clear intention of Borrower’s investors to continue to fund Borrower in the amounts and timeframe necessary, in Bank’s judgment, to enable Borrower to satisfy the Obligations as they become due and payable is the most significant criterion Bank shall consider in making any such determination.

“Monthly Financial Statements” is defined in Section 6.2(a).

“Obligations” are Borrower’s obligations to pay when due any debts, principal, interest, fees, Bank Expenses, the Prepayment Premium, the Final Payment and other amounts Borrower owes Bank now or later, whether under this Agreement, the other Loan Documents (other than the Warrant), or otherwise, including, without limitation, all obligations relating to Bank Services and any interest accruing after Insolvency Proceedings begin and debts, liabilities, or obligations of Borrower assigned to Bank, and to perform Borrower’s duties under the Loan Documents (other than the Warrant).

“Operating Documents” are, for any Person, such Person’s formation documents, as certified by the Secretary of State (or equivalent agency) of such Person’s jurisdiction of organization on a date that is no earlier than thirty (30) days prior to the Effective Date, and, (a) if such Person is a corporation, its bylaws in current form, (b) if such Person is a limited liability company, its limited liability company agreement (or similar agreement), and (c) if such Person is a partnership, its partnership agreement (or similar agreement), each of the foregoing with all current amendments or modifications thereto.

“Patents” means all patents, patent applications and like protections including without limitation improvements, divisions, continuations, renewals, reissues, extensions and continuations-in-part of the same.

“Payment/Advance Form” is that certain form attached hereto as Exhibit C.

“Payment Date” is the first (1st) calendar day of each month.

“Perfection Certificate” is defined in Section 5.1.

“Performance Milestone I” occurs if and when (if ever) Bank confirms in writing that it has received evidence, on or prior to January 31, 2022, satisfactory to Bank in Bank’s sole and absolute discretion, that each of the following has occurred on or prior to January 31, 2022: (i) the enrollment of Borrower’s first subject in the phase 1 clinical trial of ADX-097, and (ii) the initiation and continuation of Borrower’s phase 1 clinical trial of ADX-914.

 

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“Performance Milestone II” occurs if and when (if ever) Bank confirms in writing that it has received evidence, on or prior to April 30, 2022, satisfactory to Bank in Bank’s sole and absolute discretion, that Borrower has received positive data with respect to Borrower’s ADX-914 phase 1 clinical trial and sign off by the FDA or other equivalent regulatory agency on the phase 2 clinical trial design, on or prior to April 30, 2022.

“Permitted Indebtedness” is:

(a) Borrower’s Indebtedness to Bank under this Agreement and the other Loan Documents;

(b) Indebtedness existing on the Effective Date which is shown on the Perfection Certificate;

(c) Subordinated Debt;

(d) unsecured Indebtedness to trade creditors incurred in the ordinary course of business;

(e) Indebtedness incurred as a result of endorsing negotiable instruments received in the ordinary course of business;

(f) Indebtedness secured by Liens permitted under clauses (a) and (c) of the definition of Permitted Liens hereunder; and

(g) extensions, refinancings, modifications, amendments and restatements of any items of Permitted Indebtedness (a) through (f) above, provided that the principal amount thereof is not increased or the terms thereof are not modified to impose more burdensome terms upon Borrower or its Subsidiary, as the case may be.

“Permitted Investments” are:

(a) Investments (including, without limitation, Subsidiaries) existing on the Effective Date which are shown on the Perfection Certificate;

(b) After March 31, 2021, Investments by Borrower in Australian Subsidiary for ordinary, necessary and current operating expenses in an amount not to exceed Six Million Dollars ($6,000,000.00) in the aggregate in any twelve (12) month period, so long as an Event of Default does not exist at the time of any such Investment and would not exist after giving effect to any such Investment;

(c) cash Investments by Borrower in Securities Corporation; provided that (i) no Event of Default has occurred and is continuing or would result from such Investment and (ii) Borrower and its Subsidiaries are, at all times, in compliance with Section 6.6(a);

(d) Investments consisting of Cash Equivalents;

(e) Investments consisting of the endorsement of negotiable instruments for deposit or collection or similar transactions in the ordinary course of Borrower;

(f) Investments accepted in connection with Transfers permitted by Section 7.1 of this Agreement;

(g) Investments consisting of (i) travel advances and employee relocation loans and other employee loans and advances in the ordinary course of business, and (ii) loans to employees, officers or directors relating to the purchase of equity securities of Borrower or its Subsidiaries pursuant to employee stock purchase plans or agreements approved by the Board;

 

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(h) Investments (including debt obligations) received in connection with the bankruptcy or reorganization of customers or suppliers and in settlement of delinquent obligations of, and other disputes with, customers or suppliers arising in the ordinary course of business;

(i) Investments consisting of notes receivable of, or prepaid royalties and other credit extensions, to customers and suppliers who are not Affiliates, in the ordinary course of business; provided that this paragraph (j) shall not apply to Investments of Borrower in any Subsidiary;

(j) Investments by one Borrower in another Borrower or secured Guarantor; and

(k) Investments consisting of deposit accounts (but only to the extent that Borrower is permitted to maintain such accounts pursuant to Section 6.6 of this Agreement) in which Bank has a first priority perfected security interest.

“Permitted Liens” are:

(a) Liens existing on the Effective Date which are shown on the Perfection Certificate or arising under this Agreement and the other Loan Documents;

(b) Liens for taxes, fees, assessments or other government charges or levies, either (i) not due and payable or (ii) being contested in good faith and for which Borrower maintains adequate reserves on its Books, provided that no notice of any such Lien has been filed or recorded under the Internal Revenue Code of 1986, as amended, and the Treasury Regulations adopted thereunder;

(c) purchase money Liens or capital leases (i) on Equipment acquired or held by Borrower incurred for financing the acquisition of the Equipment securing no more than Two Hundred Fifty Thousand Dollars ($250,000.00) in the aggregate amount outstanding, or (ii) existing on Equipment when acquired, if the Lien is confined to the property and improvements and the proceeds of the Equipment;

(d) Liens of carriers, warehousemen, suppliers, or other Persons that are possessory in nature arising in the ordinary course of business so long as such Liens attach only to Inventory and which are not delinquent or remain payable without penalty or which are being contested in good faith and by appropriate proceedings which proceedings have the effect of preventing the forfeiture or sale of the property subject thereto;

(e) Liens to secure payment of workers’ compensation, employment insurance, old-age pensions, social security and other like obligations incurred in the ordinary course of business (other than Liens imposed by ERISA);

(f) Liens incurred in the extension, renewal or refinancing of the Indebtedness secured by Liens described in (a) through (c), but any extension, renewal or replacement Lien must be limited to the property encumbered by the existing Lien and the principal amount of the indebtedness may not increase;

(g) leases or subleases of real property granted in the ordinary course of Borrower’s business (or, if referring to another Person, in the ordinary course of such Person’s business), and leases, subleases, non-exclusive licenses or sublicenses of personal property (other than Intellectual Property) granted in the ordinary course of Borrower’s business (or, if referring to another Person, in the ordinary course of such Person’s business), if the leases, subleases, licenses and sublicenses do not prohibit granting Bank a security interest therein;

 

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(h) non-exclusive licenses of Intellectual Property granted to third parties in the ordinary course of business, and licenses of Intellectual Property that could not result in a legal transfer of title of the licensed property that may be exclusive in respects other than territory and that may be exclusive as to territory only as to discreet geographical areas outside of the United States;

(i) Liens arising from attachments or judgments, orders, or decrees in circumstances not constituting an Event of Default under Sections 8.4 and 8.7; and

(j) Liens in favor of other financial institutions arising in connection with Borrower’s deposit and/or securities accounts held at such institutions, provided that (i) Bank has a first priority perfected security interest in the amounts held in such deposit and/or securities accounts, and (ii) such accounts are permitted to be maintained pursuant to Section 6.6 of this Agreement.

“Person” is any individual, sole proprietorship, partnership, limited liability company, joint venture, company, trust, unincorporated organization, association, corporation, institution, public benefit corporation, firm, joint stock company, estate, entity or government agency.

“Prepayment Premium” shall be an additional fee, payable to Bank, with respect to the Term Loan Advances, in an amount equal to:

(a) for a prepayment of the Term Loan Advances made on or prior to the first (1st) anniversary of the Effective Date, Seven Hundred Fifty Thousand Dollars ($750,000.00);

(b) for a prepayment of the Term Loan Advances made after the first (1st) anniversary of the Effective Date, but on or prior to the second (2nd) anniversary of the Effective Date, Two Hundred Fifty Thousand Dollars ($250,000.00); and

(c) for a prepayment of the Term Loan Advances made after the second (2nd) anniversary of the Effective Date, but prior to the Term Loan Maturity Date, Zero Dollars ($0.0).

Notwithstanding the foregoing, provided no Event of Default has occurred and is continuing, the Prepayment Premium shall be waived by Bank, if Bank closes on the refinance and redocumentation of this Agreement (in its sole and absolute discretion) prior to the Term Loan Maturity Date.

“Prime Rate” is the rate of interest per annum from time to time published in the money rates section of The Wall Street Journal or any successor publication thereto as the “prime rate” then in effect; provided that, in the event such rate of interest is less than zero, such rate shall be deemed to be zero for purposes of this Agreement and provided further that if such rate of interest, as set forth from time to time in the money rates section of The Wall Street Journal, becomes unavailable for any reason as determined by Bank, the “Prime Rate” shall mean the rate of interest per annum announced by Bank as its prime rate in effect at its principal office in the State of California (such Bank announced Prime Rate not being intended to be the lowest rate of interest charged by Bank in connection with extensions of credit to debtors); provided that, in the event such rate of interest is less than zero, such rate shall be deemed to be zero for purposes of this Agreement.

“Registered Organization” is any “registered organization” as defined in the Code with such additions to such term as may hereafter be made.

 

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“Repayment Schedule” means the period of time equal to eighteen (18) consecutive calendar months, which shall be increased to a period of time equal to twenty-four (24) consecutive calendar months upon the occurrence of the Interest Only Extension Event.

“Requirement of Law” is as to any Person, the organizational or governing documents of such Person, and any law (statutory or common), treaty, rule or regulation or determination of an arbitrator or a court or other Governmental Authority, in each case applicable to or binding upon such Person or any of its property or to which such Person or any of its property is subject.

“Responsible Officer” is any of the Chief Executive Officer, President, Chief Financial Officer, Head of Corporate Development and Controller of Borrower.

“Restricted License” is any material license or other similar agreement with respect to which Borrower is the licensee (a) that prohibits or otherwise restricts Borrower from granting a security interest in Borrower’s interest in such license or agreement or any other property, or (b) for which a default under or termination of could reasonably be expected to interfere with Bank’s right to sell any Collateral.

“SEC” shall mean the Securities and Exchange Commission, any successor thereto, and any analogous Governmental Authority.

“Securities Account” is any “securities account” as defined in the Code with such additions to such term as may hereafter be made.

“Securities Corporation” is Q32 Bio Securities Corporation, a corporation organized under the laws of the Commonwealth of Massachusetts and a Subsidiary of Borrower.

“Stock Pledge Agreement” means that certain stock pledge agreement executed by Borrower in favor of Bank dated as of the Effective Date, as may be amended, modified, supplemented or restated from time to time.

“Subordinated Debt” is indebtedness incurred by Borrower subordinated to all of Borrower’s now or hereafter indebtedness to Bank (pursuant to a subordination, intercreditor, or other similar agreement in form and substance satisfactory to Bank entered into between Bank and the other creditor), on terms acceptable to Bank.

“Subsidiary” is, as to any Person, a corporation, partnership, limited liability company or other entity of which shares of stock or other ownership interests having ordinary voting power (other than stock or such other ownership interests having such power only by reason of the happening of a contingency) to elect a majority of the board of directors or other managers of such corporation, partnership or other entity are at the time owned, or the management of which is otherwise controlled, directly or indirectly through one or more intermediaries, or both, by such Person. Unless the context otherwise requires, each reference to a Subsidiary herein shall be a reference to a Subsidiary of Borrower.

“Term A Loan Advance” is defined in Section 2.1.1(a).

“Term B Loan Advance” is defined in Section 2.1.1(a).

“Term C Loan Advance” is defined in Section 2.1.1(a).

“Term D Loan Advance” is defined in Section 2.1.1(a).

 

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“Term Loan Advance” and “Term Loan Advances” are each defined in Section 2.1.1(a).

“Term Loan Amortization Date” means July 1, 2022, which shall be extended until January 1, 2023 upon the occurrence of the Interest Only Extension Event.

“Term Loan Maturity Date” is December 1, 2023, which shall be extended until December 1, 2024 upon the occurrence of the Interest Only Extension Event.

“Trademarks” means any trademark and servicemark rights, whether registered or not, applications to register and registrations of the same and like protections, and the entire goodwill of the business of Borrower connected with and symbolized by such trademarks.

“Transfer” is defined in Section 7.1.

“Warrant” is that certain warrant to purchase stock by and between Borrower and Bank dated as of the Effective Date, as may be amended, modified, supplemented and/or restated from time to time.

[Signature page follows.]

 

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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed as a sealed instrument under the laws of the Commonwealth of Massachusetts as of the Effective Date.

 

BORROWER:
Q32 BIO INC.
By:   /s/ Michael Broxson
  Name: Michael Broxson
  Title: Chief Executive Officer, Secretary
BANK:
SILICON VALLEY BANK
By:   /s/ Lauren Cole
  Name: Lauren Cole
  Title: Director

 

 

Signature Page to Loan and Security Agreement


EXHIBIT A - COLLATERAL DESCRIPTION

[***]


EXHIBIT B

[***]


EXHIBIT C- LOAN PAYMENT/ADVANCE REQUEST FORM

[***]

Exhibit 10.51

FIRST AMENDMENT

TO

LOAN AND SECURITY AGREEMENT

This First Amendment to Loan and Security Agreement (this “Amendment”) is entered into this 30th day of December, 2021 by and between SILICON VALLEY BANK (“Bank”) and Q32 BIO INC., a Delaware a corporation (“Borrower”) whose address is One Broadway, 11th Floor, Cambridge, Massachusetts 02142.

RECITALS

A. Bank and Borrower have entered into that certain Loan and Security Agreement dated as of December 11, 2020 (as the same may from time to time be amended, modified, supplemented or restated, the “Loan Agreement”).

B. Bank has extended credit to Borrower for the purposes permitted in the Loan Agreement.

C. Borrower has requested that Bank amend the Loan Agreement to make certain revisions to the Loan Agreement as more fully set forth herein.

D. Bank has agreed to so amend certain provisions of the Loan Agreement, but only to the extent, in accordance with the terms, subject to the conditions and in reliance upon the representations and warranties set forth below.

AGREEMENT

NOW, THEREFORE, in consideration of the foregoing recitals and other good and valuable consideration, the receipt and adequacy of which is hereby acknowledged, and intending to be legally bound, the parties hereto agree as follows:

1. Definitions. Capitalized terms used but not defined in this Amendment shall have the meanings given to them in the Loan Agreement.

2. Amendments to Loan Agreement.

2.1 Section 13.1 (Definitions). The following terms and their respective definitions set forth in Section 13.1 are amended in their entirety and replaced with the following:

“ “Draw Period 1” is the period of time commencing upon the Effective Date and continuing through the earlier to occur of (a) January 31, 2022, or (b) an Event of Default.

“ “Draw Period 2” is the period of time commencing upon the occurrence of Performance Milestone I and continuing through the earlier to occur of (a) April 30, 2022, or (b) an Event of Default.”


“ “Performance Milestone I” occurs if and when (if ever) Bank confirms in writing that it has received evidence, on or prior to April 30, 2022, satisfactory to Bank in Bank’s sole and absolute discretion, that each of the following has occurred on or prior to April 30, 2022: (i) the enrollment of Borrower’s first subject in the phase 1 clinical trial of ADX-097, and (ii) the initiation and continuation of Borrower’s phase 1 clinical trial of ADX-914.”

3. Limitation of Amendments.

3.1 The amendments set forth in Section 2 above are effective for the purposes set forth herein and shall be limited precisely as written and shall not be deemed to (a) be a consent to any amendment, waiver or modification of any other term or condition of any Loan Document, or (b) otherwise prejudice any right or remedy which Bank may now have or may have in the future under or in connection with any Loan Document.

3.2 This Amendment shall be construed in connection with and as part of the Loan Documents and all terms, conditions, representations, warranties, covenants and agreements set forth in the Loan Documents, except as herein amended, are hereby ratified and confirmed and shall remain in full force and effect.

4. Representations and Warranties. To induce Bank to enter into this Amendment, Borrower hereby represents and warrants to Bank as follows:

4.1 Immediately after giving effect to this Amendment (a) the representations and warranties contained in the Loan Documents are true, accurate and complete in all material respects as of the date hereof (except to the extent such representations and warranties relate to an earlier date, in which case they are true and correct in all material respects as of such date), and (b) no Event of Default has occurred and is continuing;

4.2 Borrower has the power and authority to execute and deliver this Amendment and to perform its obligations under the Loan Agreement, as amended by this Amendment;

4.3 The organizational documents of Borrower delivered to Bank on the Effective Date remain true, accurate and complete and have not been amended, supplemented or restated and are and continue to be in full force and effect;

4.4 The execution and delivery by Borrower of this Amendment and the performance by Borrower of its obligations under the Loan Agreement, as amended by this Amendment, have been duly authorized;

4.5 The execution and delivery by Borrower of this Amendment and the performance by Borrower of its obligations under the Loan Agreement, as amended by this Amendment, do not and will not contravene (a) any law or regulation binding on or affecting Borrower, (b) any contractual restriction with a Person binding on Borrower, (c) any order, judgment or decree of any court or other governmental or public body or authority, or subdivision thereof, binding on Borrower, or (d) the organizational documents of Borrower;


4.6 The execution and delivery by Borrower of this Amendment and the performance by Borrower of its obligations under the Loan Agreement, as amended by this Amendment, do not require any order, consent, approval, license, authorization or validation of, or filing, recording or registration with, or exemption by any governmental or public body or authority, or subdivision thereof, binding on Borrower, except as already has been obtained or made; and

4.7 This Amendment has been duly executed and delivered by Borrower and is the binding obligation of Borrower, enforceable against Borrower in accordance with its terms, except as such enforceability may be limited by bankruptcy, insolvency, reorganization, liquidation, moratorium or other similar laws of general application relating to or affecting creditors’ rights and by general equitable principles.

5. Updated Perfection Certificate. Borrower has delivered an updated Perfection Certificate in connection with this Amendment (the “Updated Perfection Certificate”) dated as of the date hereof, which Updated Perfection Certificate shall supersede in all respects that certain Perfection Certificate dated as of December 11, 2020. Borrower agrees that all references in the Loan Agreement to “Perfection Certificate” shall hereinafter be deemed to be a reference to the Updated Perfection Certificate.

6. Integration. This Amendment and the Loan Documents represent the entire agreement about this subject matter and supersede prior negotiations or agreements. All prior agreements, understandings, representations, warranties, and negotiations between the parties about the subject matter of this Amendment and the Loan Documents merge into this Amendment and the Loan Documents.

7. Counterparts. This Amendment may be executed in any number of counterparts and all of such counterparts taken together shall be deemed to constitute one and the same instrument.

8. Effectiveness. This Amendment shall be deemed effective upon (a) the due execution and delivery to Bank of this Amendment by each party hereto (other than Bank), (b) Borrower’s payment to Bank of Bank’s reasonable documented legal fees and expenses incurred in connection with this Amendment.

[Signature page follows.]


IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be duly executed and delivered as of the date first written above.

 

BANK     BORROWER
SILICON VALLEY BANK     Q32 BIO INC.
By:   /s/ John Sansone     By:   /s/ Michael Broxson
Name:   John Sansone     Name:   Michael Broxson
Title:   Vice President     Title:   Chief Executive Officer, Secretary

Exhibit 10.52

SECOND AMENDMENT

TO

LOAN AND SECURITY AGREEMENT

This Second Amendment to Loan and Security Agreement (this “Amendment”) is entered into this 30th day of June, 2022 by and between SILICON VALLEY BANK (“Bank”) and Q32 BIO INC., a Delaware a corporation (“Borrower”) whose address is One Broadway, 11th Floor, Cambridge, Massachusetts 02142.

RECITALS

A. Bank and Borrower have entered into that certain Loan and Security Agreement dated as of December 11, 2020, as amended by that certain First Amendment to Loan and Security Agreement between Borrower and Bank dated as of December 30, 2021 (as the same may from time to time be further amended, modified, supplemented or restated, the “Loan Agreement”).

B. Bank has extended credit to Borrower for the purposes permitted in the Loan Agreement.

C. Borrower has requested that Bank amend the Loan Agreement to make certain revisions to the Loan Agreement as more fully set forth herein.

D. Bank has agreed to so amend certain provisions of the Loan Agreement, but only to the extent, in accordance with the terms, subject to the conditions and in reliance upon the representations and warranties set forth below.

AGREEMENT

NOW, THEREFORE, in consideration of the foregoing recitals and other good and valuable consideration, the receipt and adequacy of which is hereby acknowledged, and intending to be legally bound, the parties hereto agree as follows:

1. Definitions. Capitalized terms used but not defined in this Amendment shall have the meanings given to them in the Loan Agreement.

2. Amendments to Loan Agreement.

2.1 Section 13.1 (Definitions). The following terms and their respective definitions set forth in Section 13.1 are amended in their entirety and replaced with the following:

“ “Final Payment” is a payment (in addition to and not in substitution for the regular monthly payments of principal plus accrued interest) equal to the aggregate original principal amount of the Term Loan Advance extended by Bank to Borrower hereunder, multiplied by four percent (4.0%), due on the earliest to occur of (a) the Term Loan Maturity Date, (b) the payment in full of the Term Loan Advance, (c) as required by 2.1.1(d) or 2.1.1(e), or (d) the termination of this Agreement.”


“ “Prepayment Premium” shall be an additional fee, payable to Bank, with respect to the Term Loan Advance, in an amount equal to:

(a) for a prepayment of the Term Loan Advance made on or prior to the first (1st) anniversary of the Second Amendment Effective Date, Seven Hundred Fifty Thousand Dollars ($750,000.00);

(b) for a prepayment of the Term Loan Advance made after the first (1st) anniversary of the Second Amendment Effective Date, but on or prior to the second (2nd) anniversary of the Second Amendment Effective Date, Two Hundred Fifty Thousand Dollars ($250,000.00); and

(c) for a prepayment of the Term Loan Advance made after the second (2nd) anniversary of the Second Amendment Effective Date, but on or prior to the Term Loan Maturity Date, Zero Dollars ($0.00).

Notwithstanding the foregoing, provided no Event of Default has occurred and is continuing, the Prepayment Premium shall be waived by Bank, if Bank closes on the refinance and redocumentation of this Agreement (in its sole and absolute discretion) prior to the Term Loan Maturity Date.”

“ “Repayment Schedule” means the period of time equal to twenty-four (24) consecutive calendar months.”

“ “Term Loan Amortization Date” is January 1, 2023.”

“ “Term Loan Maturity Date” is December 1, 2024.”

2.2 Section 13.1 (Definitions). The Loan Agreement is amended by inserting the following new term and its respective definition to appear alphabetically in Section 13.1 thereof:

“ “Second Amendment Effective Date” is June 30, 2022.”

3. Limitation of Amendments.

3.1 The amendments set forth in Section 2 above are effective for the purposes set forth herein and shall be limited precisely as written and shall not be deemed to (a) be a consent to any amendment, waiver or modification of any other term or condition of any Loan Document, or (b) otherwise prejudice any right or remedy which Bank may now have or may have in the future under or in connection with any Loan Document.

3.2 This Amendment shall be construed in connection with and as part of the Loan Documents and all terms, conditions, representations, warranties, covenants and agreements set forth in the Loan Documents, except as herein amended, are hereby ratified and confirmed and shall remain in full force and effect.


4. Representations and Warranties. To induce Bank to enter into this Amendment, Borrower hereby represents and warrants to Bank as follows:

4.1 Immediately after giving effect to this Amendment (a) the representations and warranties contained in the Loan Documents are true, accurate and complete in all material respects as of the date hereof (except to the extent such representations and warranties relate to an earlier date, in which case they are true and correct in all material respects as of such date), and (b) no Event of Default has occurred and is continuing;

4.2 Borrower has the power and authority to execute and deliver this Amendment and to perform its obligations under the Loan Agreement, as amended by this Amendment;

4.3 The organizational documents of Borrower delivered to Bank on the Effective Date remain true, accurate and complete and have not been amended, supplemented or restated and are and continue to be in full force and effect;

4.4 The execution and delivery by Borrower of this Amendment and the performance by Borrower of its obligations under the Loan Agreement, as amended by this Amendment, have been duly authorized;

4.5 The execution and delivery by Borrower of this Amendment and the performance by Borrower of its obligations under the Loan Agreement, as amended by this Amendment, do not and will not contravene (a) any law or regulation binding on or affecting Borrower, (b) any contractual restriction with a Person binding on Borrower, (c) any order, judgment or decree of any court or other governmental or public body or authority, or subdivision thereof, binding on Borrower, or (d) the organizational documents of Borrower;

4.6 The execution and delivery by Borrower of this Amendment and the performance by Borrower of its obligations under the Loan Agreement, as amended by this Amendment, do not require any order, consent, approval, license, authorization or validation of, or filing, recording or registration with, or exemption by any governmental or public body or authority, or subdivision thereof, binding on Borrower, except as already has been obtained or made; and

4.7 This Amendment has been duly executed and delivered by Borrower and is the binding obligation of Borrower, enforceable against Borrower in accordance with its terms, except as such enforceability may be limited by bankruptcy, insolvency, reorganization, liquidation, moratorium or other similar laws of general application relating to or affecting creditors’ rights and by general equitable principles.

5. Ratification of Perfection Certificate. Borrower hereby ratifies, confirms and reaffirms, all and singular, the terms and disclosures contained in a certain Perfection Certificate of Borrower dated as of December 30, 2021, and acknowledges, confirms and agrees that the disclosures and information Borrower provided to Bank in said Perfection Certificate have not changed, as of the date hereof.


6. Integration. This Amendment and the Loan Documents represent the entire agreement about this subject matter and supersede prior negotiations or agreements. All prior agreements, understandings, representations, warranties, and negotiations between the parties about the subject matter of this Amendment and the Loan Documents merge into this Amendment and the Loan Documents.

7. Counterparts. This Amendment may be executed in any number of counterparts and all of such counterparts taken together shall be deemed to constitute one and the same instrument.

8. Effectiveness. This Amendment shall be deemed effective upon (a) the due execution and delivery to Bank of this Amendment by each party hereto (other than Bank), and (b) Borrower’s payment to Bank of Bank’s reasonable documented legal fees and expenses incurred in connection with this Amendment.

[Signature page follows.]


IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be duly executed and delivered as of the date first written above.

 

BANK     BORROWER
SILICON VALLEY BANK     Q32 BIO INC.
By:   /s/ Michael Broxson     By:   /s/ John Sansone
Name:   Michael Broxson     Name:   John Sansone
Title:   Chief Executive Officer     Title:   Vice President

NY: 2405058

Exhibit 10.53

THIRD AMENDMENT

TO

LOAN AND SECURITY AGREEMENT

This Third Amendment to Loan and Security Agreement (this “Amendment”) is entered into this 10th day of August, 2022 by and between SILICON VALLEY BANK (“Bank”) and Q32 BIO INC., a Delaware a corporation (“Borrower”) whose address is One Broadway, 11th Floor, Cambridge, Massachusetts 02142.

RECITALS

A. Bank and Borrower have entered into that certain Loan and Security Agreement dated as of December 11, 2020, as amended by that certain First Amendment to Loan and Security Agreement by and between Borrower and Bank dated as of December 30, 2021, and as further amended by that certain Second Amendment to Loan and Security Agreement by and between Borrower and Bank dated as of June 30, 2022 (as the same may from time to time be further amended, modified, supplemented or restated, the “Loan Agreement”).

B. Bank has extended credit to Borrower for the purposes permitted in the Loan Agreement.

C. Borrower has requested that Bank amend the Loan Agreement to make certain revisions to the Loan Agreement as more fully set forth herein.

D. Bank has agreed to so amend certain provisions of the Loan Agreement, but only to the extent, in accordance with the terms, subject to the conditions and in reliance upon the representations and warranties set forth below.

AGREEMENT

NOW, THEREFORE, in consideration of the foregoing recitals and other good and valuable consideration, the receipt and adequacy of which is hereby acknowledged, and intending to be legally bound, the parties hereto agree as follows:

1. Definitions. Capitalized terms used but not defined in this Amendment shall have the meanings given to them in the Loan Agreement.

2. Amendments to Loan Agreement.

2.1 Section 6.12 (Cash Collateralization). The following new Section 6.12 of the Loan Agreement is hereby inserted to appear immediately following Section 6.11 thereof:

“6.12 Cash Collateralization. As of the Third Amendment Effective Date, Borrower shall deposit and maintain at all times, in the Collateral Money Market Account unrestricted and unencumbered cash in an amount equal to $5,000,000.00 to secure the outstanding principal amount of the Term Loan Advances (a “Cash Collateralization”). Borrower hereby authorizes and directs Bank to transfer to the Collateral Money Market Account an amount equal to

 

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$5,000,000.00, if Borrower fails to effect a Cash Collateralization as required under this Section 6.12. Borrower further authorizes Bank, at the election of Bank, in Bank’s sole and absolute discretion, to apply the funds held in the Collateral Money Market Account on account of the outstanding Obligations of Borrower to Bank (the “Paydown Payment”).”

2.2 Section 7.1 (Dispositions). Section 7.1 is amended by (i) deleting the word “and” before clause (f) thereof, (ii) deleting the “.” at the end of clause (f) thereof and inserting in lieu thereof “; and” and (iii) inserting the following new clause (g) thereof:

“(g) consisting of Borrower’s grant to Horizon of an exclusive and irrevocable option (the “Option”) to purchase the Acquired Assets under the Option Agreement and, if the Option is exercised, the sale of the Acquired Assets under the Purchase Agreement (the “Option Transaction”).

2.3 Section 8.2(a) (Covenant Default). Section 8.2(a) is amended by (i) deleting the word “or” appearing immediately prior to the text “6.11” and (ii) inserting the words “or 6.12” immediately following the text “6.11”.

2.4 Section 13.1 (Definitions). The definition of “Permitted Liens” is amended by (i) deleting the word “and” at the end of clause (i) thereof, (ii) deleting the “.” at the end of clause (j) thereof and inserting in lieu thereof “; and” and (iii) inserting the following new clause (k) thereof to appear immediately following clause (j) thereof:

“(k) Liens consisting of the Option Transaction.”

2.5 Section 13.1 (Definitions). The following term and its respective definition is amended in its entirety and replaced with the following:

“ “Loan Documents” are, collectively, this Agreement and any schedules, exhibits, certificates, notices, and any other documents related to this Agreement, the Warrant, the Cash Pledge Agreement, the Perfection Certificate, the Stock Pledge Agreement, any Control Agreement, any Bank Services Agreement, any subordination agreement, any note, or notes or guaranties executed by Borrower, and any other present or future agreement by Borrower with or for the benefit of Bank in connection with this Agreement or Bank Services, all as amended, restated, or otherwise modified.”

2.6 Section 13.1 (Definitions). The following new terms and their respective definitions are hereby inserted to appear alphabetically in Section 13.1 thereof:

“ “Acquired Assets” has the meaning given to such term in the Purchase Agreement.”

“ “Cash Collateralization” is defined in Section 6.12.”

“ “Paydown Payment” is defined in Section 6.12.”

 

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“ “Cash Pledge Agreement” is that certain Cash Pledge Agreement dated as of the Third Amendment Effective Date executed by Borrower in favor of Bank.”

“ “Collateral Money Market Account” means a separate segregated collateral money market account of Borrower maintained with Bank, which is subject to the Cash Pledge Agreement.”

“ “Horizon” means Horizon Therapeutics Ireland DAC, an entity organized under the laws of Ireland.”

“ “Option Agreement” means that certain Collaboration and Option Agreement between Borrower and Horizon dated on or about the date hereof in the form attached to the Third Amendment as Schedule 1.”

“ “Option Transaction” is defined in Section 7.1.”

“ “Purchase Agreement” means that certain Asset Purchase Agreement between Borrower and Horizon dated on or about the date hereof in the form attached to the Third Amendment as Schedule 2.”

“ “Release Event” occurs if and when (if ever) Borrower has sold the Acquired Assets to Horizon, as confirmed by Bank in writing following receipt of evidence from Borrower satisfactory to Bank of the sale.”

“ “Third Amendment” means that certain Third Amendment to Loan and Security Agreement by and between Borrower and Bank, dated as of the Third Amendment Effective Date.”

“ “Third Amendment Effective Date” is August 10, 2022.”

3. Limitation of Amendments.

3.1 The amendments set forth in Section 2 above are effective for the purposes set forth herein and shall be limited precisely as written and shall not be deemed to (a) be a consent to any amendment, waiver or modification of any other term or condition of any Loan Document, or (b) otherwise prejudice any right or remedy which Bank may now have or may have in the future under or in connection with any Loan Document.

3.2 This Amendment shall be construed in connection with and as part of the Loan Documents and all terms, conditions, representations, warranties, covenants and agreements set forth in the Loan Documents, except as herein amended, are hereby ratified and confirmed and shall remain in full force and effect.

4. Release of Liens in the Acquired Assets. Upon Bank’s confirmation that the Release Event has occurred, Bank automatically and effective as of the consummation of the sale of the Acquired Assets pursuant to the terms of the Purchase Agreement, (a) releases any and all security interests and liens it may have in the Acquired Assets, (b) agrees that such security interests and liens on such Acquired Assets shall be of no further force and effect, and (c) upon request from Borrower, agrees to file promptly at Borrower’s sole cost and expense, a UCC-3 partial release with respect to the Acquired Assets that are sold pursuant to the Purchase Agreement.

 

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5. Representations and Warranties. To induce Bank to enter into this Amendment, Borrower hereby represents and warrants to Bank as follows:

5.1 Immediately after giving effect to this Amendment (a) the representations and warranties contained in the Loan Documents are true, accurate and complete in all material respects as of the date hereof (except to the extent such representations and warranties relate to an earlier date, in which case they are true and correct in all material respects as of such date), and (b) no Event of Default has occurred and is continuing;

5.2 Borrower has the power and authority to execute and deliver this Amendment and to perform its obligations under the Loan Agreement, as amended by this Amendment;

5.3 The organizational documents of Borrower delivered to Bank on the Effective Date remain true, accurate and complete and have not been amended, supplemented or restated and are and continue to be in full force and effect;

5.4 The execution and delivery by Borrower of this Amendment and the performance by Borrower of its obligations under the Loan Agreement, as amended by this Amendment, have been duly authorized;

5.5 The execution and delivery by Borrower of this Amendment and the performance by Borrower of its obligations under the Loan Agreement, as amended by this Amendment, do not and will not contravene (a) any law or regulation binding on or affecting Borrower, (b) any contractual restriction with a Person binding on Borrower, (c) any order, judgment or decree of any court or other governmental or public body or authority, or subdivision thereof, binding on Borrower, or (d) the organizational documents of Borrower;

5.6 The execution and delivery by Borrower of this Amendment and the performance by Borrower of its obligations under the Loan Agreement, as amended by this Amendment, do not require any order, consent, approval, license, authorization or validation of, or filing, recording or registration with, or exemption by any governmental or public body or authority, or subdivision thereof, binding on Borrower, except as already has been obtained or made; and

5.7 This Amendment has been duly executed and delivered by Borrower and is the binding obligation of Borrower, enforceable against Borrower in accordance with its terms, except as such enforceability may be limited by bankruptcy, insolvency, reorganization, liquidation, moratorium or other similar laws of general application relating to or affecting creditors’ rights and by general equitable principles.

6. Ratification of Perfection Certificate. Borrower hereby ratifies, confirms and reaffirms, all and singular, the terms and disclosures contained in a certain Perfection Certificate of Borrower dated as of December 30, 2021, and acknowledges, confirms and agrees that the disclosures and information Borrower provided to Bank in said Perfection Certificate have not changed, as of the date hereof.

 

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7. Integration. This Amendment and the Loan Documents represent the entire agreement about this subject matter and supersede prior negotiations or agreements. All prior agreements, understandings, representations, warranties, and negotiations between the parties about the subject matter of this Amendment and the Loan Documents merge into this Amendment and the Loan Documents.

8. Counterparts. This Amendment may be executed in any number of counterparts and all of such counterparts taken together shall be deemed to constitute one and the same instrument.

9. Effectiveness. This Amendment shall be deemed effective upon (a) the due execution and delivery to Bank of this Amendment by each party hereto (other than Bank), and (b) Borrower’s payment to Bank of Bank’s reasonable documented legal fees and expenses incurred in connection with this Amendment.

[Signature page follows.]

 

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IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be duly executed and delivered as of the date first written above.

 

BANK     BORROWER
SILICON VALLEY BANK     Q32 BIO INC.
By:   /s/ John Sansone     By:   /s/ Michael Broxson
Name:   John Sansone     Name:   Michael Broxson
Title:   Vice President     Title:   Chief Executive Officer

Exhibit 10.54

FOURTH AMENDMENT

TO

LOAN AND SECURITY AGREEMENT

This Fourth Amendment to Loan and Security Agreement (this “Amendment”) is entered into this 21st day of December, 2022 by and between SILICON VALLEY BANK (“Bank”) and Q32 BIO INC., a Delaware corporation (“Borrower”) whose address is 830 Winter Street, Waltham, Massachusetts 02451.

RECITALS

A. Bank and Borrower have entered into that certain Loan and Security Agreement dated as of December 11, 2020, as amended by that certain First Amendment to Loan and Security Agreement by and between Borrower and Bank dated as of December 30, 2021, as further amended by that certain Second Amendment to Loan and Security Agreement by and between Borrower and Bank dated as of June 30, 2022, and as further amended by that certain Third Amendment to Loan and Security Agreement by and between Borrower and Bank dated as of August 10, 2022 (as the same may from time to time be further amended, modified, supplemented or restated, the “Loan Agreement”).

B. Bank has extended credit to Borrower for the purposes permitted in the Loan Agreement.

C. Borrower has requested that Bank amend the Loan Agreement to make certain revisions to the Loan Agreement as more fully set forth herein.

D. Bank has agreed to so amend certain provisions of the Loan Agreement, but only to the extent, in accordance with the terms, subject to the conditions and in reliance upon the representations and warranties set forth below.

AGREEMENT

NOW, THEREFORE, in consideration of the foregoing recitals and other good and valuable consideration, the receipt and adequacy of which is hereby acknowledged, and intending to be legally bound, the parties hereto agree as follows:

1. Definitions. Capitalized terms used but not defined in this Amendment shall have the meanings given to them in the Loan Agreement.

2. Amendments to Loan Agreement.

2.1 Section 13.1 (Definitions). The following terms and their respective definitions are amended in their entirety and replaced with the following:

“ “Repayment Schedule” means the period of time equal to eighteen (18) consecutive calendar months.”

“ “Term Loan Amortization Date” is July 1, 2023.”


3. Limitation of Amendments.

3.1 The amendments set forth in Section 2 above are effective for the purposes set forth herein and shall be limited precisely as written and shall not be deemed to (a) be a consent to any amendment, waiver or modification of any other term or condition of any Loan Document, or (b) otherwise prejudice any right or remedy which Bank may now have or may have in the future under or in connection with any Loan Document.

3.2 This Amendment shall be construed in connection with and as part of the Loan Documents and all terms, conditions, representations, warranties, covenants and agreements set forth in the Loan Documents, except as herein amended, are hereby ratified and confirmed and shall remain in full force and effect.

4. Representations and Warranties. To induce Bank to enter into this Amendment, Borrower hereby represents and warrants to Bank as follows:

4.1 Immediately after giving effect to this Amendment (a) the representations and warranties contained in the Loan Documents are true, accurate and complete in all material respects as of the date hereof (except to the extent such representations and warranties relate to an earlier date, in which case they are true and correct in all material respects as of such date), and (b) no Event of Default has occurred and is continuing;

4.2 Borrower has the power and authority to execute and deliver this Amendment and to perform its obligations under the Loan Agreement, as amended by this Amendment;

4.3 Except as amended by the Certificates of Amendment to Borrower’s Second Amended and Restated Certificate of Incorporation, filed on May 20, 2022 and December 8, 2022, the organizational documents of Borrower delivered to Bank on the Effective Date remain true, accurate and complete and have not been amended, supplemented or restated and are and continue to be in full force and effect;

4.4 The execution and delivery by Borrower of this Amendment and the performance by Borrower of its obligations under the Loan Agreement, as amended by this Amendment, have been duly authorized;

4.5 The execution and delivery by Borrower of this Amendment and the performance by Borrower of its obligations under the Loan Agreement, as amended by this Amendment, do not and will not contravene (a) any law or regulation binding on or affecting Borrower, (b) any contractual restriction with a Person binding on Borrower, (c) any order, judgment or decree of any court or other governmental or public body or authority, or subdivision thereof, binding on Borrower, or (d) the organizational documents of Borrower;

4.6 The execution and delivery by Borrower of this Amendment and the performance by Borrower of its obligations under the Loan Agreement, as amended by this Amendment, do not require any order, consent, approval, license, authorization or validation of, or filing, recording or registration with, or exemption by any governmental or public body or authority, or subdivision thereof, binding on Borrower, except as already has been obtained or made; and


4.7 This Amendment has been duly executed and delivered by Borrower and is the binding obligation of Borrower, enforceable against Borrower in accordance with its terms, except as such enforceability may be limited by bankruptcy, insolvency, reorganization, liquidation, moratorium or other similar laws of general application relating to or affecting creditors’ rights and by general equitable principles.

5. Ratification of Perfection Certificate. Borrower hereby ratifies, confirms and reaffirms, all and singular, the terms and disclosures contained in a certain Perfection Certificate of Borrower dated as of December 30, 2021, and acknowledges, confirms and agrees that the disclosures and information Borrower provided to Bank in said Perfection Certificate have not changed, as of the date hereof, except to the extent set forth on Schedule A attached hereto.

6. Integration. This Amendment and the Loan Documents represent the entire agreement about this subject matter and supersede prior negotiations or agreements. All prior agreements, understandings, representations, warranties, and negotiations between the parties about the subject matter of this Amendment and the Loan Documents merge into this Amendment and the Loan Documents.

7. Counterparts. This Amendment may be executed in any number of counterparts and all of such counterparts taken together shall be deemed to constitute one and the same instrument.

8. Effectiveness. This Amendment shall be deemed effective upon (a) the due execution and delivery to Bank of this Amendment by each party hereto (other than Bank), and (b) Borrower’s payment to Bank of Bank’s reasonable documented legal fees and expenses incurred in connection with this Amendment.

[Signature page follows.]


IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be duly executed and delivered as of the date first written above.

 

BANK     BORROWER
SILICON VALLEY BANK     Q32 BIO INC.
By:   /s/ John Sansone     By:   /s/ Jodie Morrison
Name:   John Sansone     Name:   Jodie Morrison
Title:   Vice President     Title:   Chief Executive Officer and President

Exhibit 10.55

FIFTH AMENDMENT

TO

LOAN AND SECURITY AGREEMENT

This Fifth Amendment to Loan and Security Agreement (this “Amendment”) is entered into this 26th day of April, 2023 by and between Silicon Valley Bank, a division of First-Citizens Bank & Trust Company (successor by purchase to the Federal Deposit Insurance Corporation as Receiver for Silicon Valley Bridge Bank, N.A. (as successor to Silicon Valley Bank)) (“Bank”) and Q32 Bio Inc., a Delaware corporation (“Borrower”) whose address is 830 Winter Street, Waltham, Massachusetts 02451.

RECITALS

A. Bank and Borrower have entered into that certain Loan and Security Agreement dated as of December 11, 2020, as amended by that certain First Amendment to Loan and Security Agreement by and between Borrower and Bank dated as of December 30, 2021, as further amended by that certain Second Amendment to Loan and Security Agreement by and between Borrower and Bank dated as of June 30, 2022, as amended by that certain Third Amendment to Loan and Security Agreement by and between Borrower and Bank dated as of August 10, 2022, and as further amended by that certain Fourth Amendment to Loan and Security Agreement by and between Borrower and Bank dated as of December 21, 2022 (as the same may from time to time be further amended, modified, supplemented or restated, the “Loan Agreement”).

B. Bank has extended credit to Borrower for the purposes permitted in the Loan Agreement.

C. Borrower has requested that Bank amend the Loan Agreement to make certain revisions to the Loan Agreement as more fully set forth herein.

D. Bank has agreed to so amend certain provisions of the Loan Agreement, but only to the extent, in accordance with the terms, subject to the conditions and in reliance upon the representations and warranties set forth below.

AGREEMENT

NOW, THEREFORE, in consideration of the foregoing recitals and other good and valuable consideration, the receipt and adequacy of which is hereby acknowledged, and intending to be legally bound, the parties hereto agree as follows:

1. Definitions. Capitalized terms used but not defined in this Amendment shall have the meanings given to them in the Loan Agreement.

2. Amendments to Loan Agreement.

2.1 Section 6.6 (Accounts). Section 6.6 is amended in its entirety and replaced with the following:

“6.6 (Accounts).


(a) Commencing as of the Fifth Amendment Effective Date, maintain a portion of Borrower’s, any of its Subsidiaries’ (excluding Securities Corporation), and any Guarantor’s primary operating accounts, depository accounts and excess cash with Bank; provided that, account balances in the name of Borrower at Bank shall represent at least 50.0% of Borrower’s, its Subsidiaries’ and any Guarantor’s consolidated cash wherever located. In addition to the foregoing, Borrower shall at all times have on deposit in operating and depository accounts maintained in the name of Borrower with Bank, unrestricted and unencumbered cash in an amount equal to the lesser of (i) one hundred percent (100.0%) of the Dollar value of Borrower’s consolidated cash, including any Subsidiaries’, Affiliates’, or related entities’ cash, in the aggregate, wherever located, and (ii) one hundred ten percent (110.0%) of the then-outstanding Obligations of Borrower to Bank. So long as, in each case, Borrower is in compliance with the terms of this Section 6.6(a) hereof, Borrower shall be permitted to maintain accounts with other banks or financial institutions (other than Bank) (the “Permitted Accounts”); provided that such Permitted Accounts shall be subject to a Control Agreement in favor of Bank pursuant to the terms of Sections 6.6(b) and 6.11 hereof.

(b) In addition to and without limiting the restrictions in (a), Borrower shall provide Bank five (5) days prior written notice before establishing any Collateral Account at or with any bank or financial institution other than Bank or Bank’s Affiliates. For each Collateral Account that Borrower at any time maintains, Borrower shall cause the applicable bank or financial institution (other than Bank) at or with which any Collateral Account is maintained to execute and deliver a Control Agreement or other appropriate instrument with respect to such Collateral Account to perfect Bank’s Lien in such Collateral Account in accordance with the terms hereunder which Control Agreement may not be terminated without the prior written consent of Bank. The provisions of the previous sentence shall not apply to (i) deposit accounts exclusively used for payroll, payroll taxes, and other employee wage and benefit payments to or for the benefit of Borrower’s employees and identified to Bank by Borrower as such and (ii) the Permitted Banking Services Cash Collateral Account ((i) and (ii), collectively, the “Excluded Accounts”).”

2.2 Section 6.11 (Post-Closing Condition). Section 6.11 of the Loan Agreement is amended in its entirety and replaced with the following:

“ 6.11 Post-Closing Condition. Deliver to Bank within 30 days after the Fifth Amendment Effective Date or such other date as approved by Bank in writing on a case-by-case basis in its sole discretion, a duly executed Control Agreement with respect to the Permitted Accounts.”

2.3 Section 13.1 (Definitions). Clause (b) of the definition of Permitted Indebtedness is amended in its entirety and replaced with the following:

“ (b) Indebtedness existing on the Effective Date which is shown on the Perfection Certificate (other than with respect to the Permitted Bank Services);”


2.4 Section 13.1 (Definitions). The definition of Permitted Indebtedness is amended by (i) deleting the word “and” appearing at the end of clause (f) thereof, (ii) deleting the “.” at the end of clause (g) and inserting in lieu thereof “; and” and (iii) inserting the following new clause (h) to appear immediately following clause (g) thereof:

“ (h) Indebtedness incurred in connection with Borrower’s letters of credit and corporate credit cards maintained with financial institutions other than Bank in an aggregate amount not to exceed $750,000.00 at any time (collectively, the “Permitted Bank Services”).”

2.5 Section 13.1 (Definitions). Clause (a) of the definition of Permitted Liens is amended by inserting the words “(other than with respect to the Permitted Bank Services)” to appear immediately following the words “Perfection Certificate” appearing therein.

2.6 Section 13.1 (Definitions). The definition of Permitted Liens is amended by (i) deleting the word “and” appearing at the end of clause (j) thereof, (ii) deleting the “.” at the end of clause (k) thereof and inserting in lieu thereof “;”, and (iii) inserting the following new clause (l) thereof to appear immediately following clause (j) thereof:

“ (l) the Lien on the collateral account securing the obligations with respect to the Permitted Bank Services in an amount not to exceed $750,000.00 in the aggregate (the “Permitted Banking Services Cash Collateral Account”).”

2.7 Section 13.1 (Definitions). The Loan Agreement is amended by inserting the following new defined terms and their respective definitions to appear alphabetically in Section 13.1 thereof:

“ “Fifth Amendment Effective Date” is April 26, 2023.”

“ “Permitted Accounts” is defined in Section 6.6(a).”

“ “Permitted Bank Services” is defined in clause (h) of Permitted Indebtedness.”

“ “Permitted Banking Services Cash Collateral Account” is defined in clause (l) of Permitted Liens.”

2.8 Exhibit B (Compliance Statement). The Compliance Statement is amended in its entirety and replaced with the Compliance Statement in the form of Schedule 1 attached hereto.

3. Limitation of Amendments.

3.1 The amendments set forth in Section 2 above are effective for the purposes set forth herein and shall be limited precisely as written and shall not be deemed to (a) be a consent to any amendment, waiver or modification of any other term or condition of any Loan Document, or (b) otherwise prejudice any right or remedy which Bank may now have or may have in the future under or in connection with any Loan Document.


3.2 This Amendment shall be construed in connection with and as part of the Loan Documents and all terms, conditions, representations, warranties, covenants and agreements set forth in the Loan Documents, except as herein amended, are hereby ratified and confirmed and shall remain in full force and effect.

4. Representations and Warranties. To induce Bank to enter into this Amendment, Borrower hereby represents and warrants to Bank as follows:

4.1 Immediately after giving effect to this Amendment (a) the representations and warranties contained in the Loan Documents are true, accurate and complete in all material respects as of the date hereof (except to the extent such representations and warranties relate to an earlier date, in which case they are true and correct in all material respects as of such date), and (b) no Event of Default has occurred and is continuing;

4.2 Borrower has the power and authority to execute and deliver this Amendment and to perform its obligations under the Loan Agreement, as amended by this Amendment;

4.3 The organizational documents of Borrower delivered to Bank on December 11, 2020 remain true, accurate and complete and have not been amended, supplemented or restated and are and continue to be in full force and effect;

4.4 The execution and delivery by Borrower of this Amendment and the performance by Borrower of its obligations under the Loan Agreement, as amended by this Amendment, have been duly authorized;

4.5 The execution and delivery by Borrower of this Amendment and the performance by Borrower of its obligations under the Loan Agreement, as amended by this Amendment, do not and will not contravene (a) any law or regulation binding on or affecting Borrower, (b) any contractual restriction with a Person binding on Borrower, (c) any order, judgment or decree of any court or other governmental or public body or authority, or subdivision thereof, binding on Borrower, or (d) the organizational documents of Borrower;

4.6 The execution and delivery by Borrower of this Amendment and the performance by Borrower of its obligations under the Loan Agreement, as amended by this Amendment, do not require any order, consent, approval, license, authorization or validation of, or filing, recording or registration with, or exemption by any governmental or public body or authority, or subdivision thereof, binding on Borrower, except as already has been obtained or made; and

4.7 This Amendment has been duly executed and delivered by Borrower and is the binding obligation of Borrower, enforceable against Borrower in accordance with its terms, except as such enforceability may be limited by bankruptcy, insolvency, reorganization, liquidation, moratorium or other similar laws of general application relating to or affecting creditors’ rights and by general equitable principles.


5. Release by Borrower:

5.1 FOR GOOD AND VALUABLE CONSIDERATION, Borrower hereby forever relieves, releases, and discharges Bank and its present or former employees, officers, directors, agents, representatives, attorneys, and each of them, from any and all claims, debts, liabilities, demands, obligations, promises, acts, agreements, costs and expenses, actions and causes of action, of every type, kind, nature, description or character whatsoever, whether known or unknown, suspected or unsuspected, absolute or contingent, arising out of or in any manner whatsoever connected with or related to facts, circumstances, issues, controversies or claims existing or arising from the beginning of time through and including the date of execution of this Amendment (collectively “Released Claims”). Without limiting the foregoing, the Released Claims shall include any and all liabilities or claims arising out of or in any manner whatsoever connected with or related to the Loan Documents, the recitals hereto, any instruments, agreements or documents executed in connection with any of the foregoing or the origination, negotiation, administration, servicing and/or enforcement of any of the foregoing.

5.2 In furtherance of this release, Borrower expressly acknowledges and waives any and all rights under Section 1542 of the California Civil Code, which provides as follows:

“A general release does not extend to claims that the creditor or releasing party does not know or suspect to exist in his or her favor at the time of executing the release and that, if known by him or her, would have materially affected his or her settlement with the debtor or released party.” (Emphasis added.)

5.3 By entering into this release, Borrower recognizes that no facts or representations are ever absolutely certain and it may hereafter discover facts in addition to or different from those which it presently knows or believes to be true, but that it is the intention of Borrower hereby to fully, finally and forever settle and release all matters, disputes and differences, known or unknown, suspected or unsuspected; accordingly, if Borrower should subsequently discover that any fact that it relied upon in entering into this release was untrue, or that any understanding of the facts was incorrect, Borrower shall not be entitled to set aside this release by reason thereof, regardless of any claim of mistake of fact or law or any other circumstances whatsoever. Borrower acknowledges that it is not relying upon and has not relied upon any representation or statement made by Bank with respect to the facts underlying this release or with regard to any of such party’s rights or asserted rights.

5.4 This release may be pleaded as a full and complete defense and/or as a cross-complaint or counterclaim against any action, suit, or other proceeding that may be instituted, prosecuted or attempted in breach of this release. Borrower acknowledges that the release contained herein constitutes a material inducement to Bank to enter into this Amendment, and that Bank would not have done so but for Bank’s expectation that such release is valid and enforceable in all events.


5.5 Borrower hereby represents and warrants to Bank, and Bank is relying thereon, as follows:

(a) Except as expressly stated in this Amendment, neither Bank nor any agent, employee or representative of Bank has made any statement or representation to Borrower regarding any fact relied upon by Borrower in entering into this Amendment.

(b) Borrower has made such investigation of the facts pertaining to this Amendment and all of the matters appertaining thereto, as it deems necessary.

(c) The terms of this Amendment are contractual and not a mere recital.

(d) This Amendment has been carefully read by Borrower, the contents hereof are known and understood by Borrower, and this Amendment is signed freely, and without duress, by Borrower.

(e) Borrower represents and warrants that it is the sole and lawful owner of all right, title and interest in and to every claim and every other matter which it releases herein, and that it has not heretofore assigned or transferred, or purported to assign or transfer, to any person, firm or entity any claims or other matters herein released. Borrower shall indemnify Bank, defend and hold it harmless from and against all claims based upon or arising in connection with prior assignments or purported assignments or transfers of any claims or matters released herein.

6. Fees and Expenses. Borrower shall reimburse Bank for all unreimbursed Bank Expenses, including without limitation, all reasonable documented legal fees and expenses incurred in connection with this Amendment.

7. Governing Law. This Amendment shall be governed and construed in accordance with the laws of the Commonwealth of Massachusetts, without giving effect to conflicts of laws principles.

8. Integration. This Amendment and the Loan Documents represent the entire agreement about this subject matter and supersede prior negotiations or agreements. All prior agreements, understandings, representations, warranties, and negotiations between the parties about the subject matter of this Amendment and the Loan Documents merge into this Amendment and the Loan Documents.

9. Counterparts. This Amendment may be executed in any number of counterparts and all of such counterparts taken together shall be deemed to constitute one and the same instrument. Each party hereto may execute this Amendment by electronic means and recognizes and accepts the use of electronic signatures and records by any other party hereto in connection with the execution and storage hereof.

10. Effectiveness. This Amendment shall be deemed effective as of the due execution and delivery to Bank of this Amendment by each party hereto.

[Signature page follows.]


IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be duly executed and delivered as a sealed instrument under the laws of the Commonwealth of Massachusetts as of the date first written above.

 

BANK     BORROWER
FIRST-CITIZENS BANK & TRUST COMPANY (SUCCESSOR BY PURCHASE TO THE FEDERAL DEPOSIT INSURANCE CORPORATION AS RECEIVER FOR SILICON VALLEY BRIDGE BANK, N.A. (AS SUCCESSOR TO SILICON VALLEY BANK))     Q32 BIO INC.
By:   /s/ John Sansone     By:   /s/ Adam Cutler
Name:   John Sansone     Name:   Adam Cutler
Title:   Vice President     Title:   CFO and Treasurer

Exhibit 10.56

SIXTH AMENDMENT

TO

LOAN AND SECURITY AGREEMENT

This Sixth Amendment to Loan and Security Agreement (this “Amendment”) is entered into this 12th day of July, 2023 by and between Silicon Valley Bank, a division of First-Citizens Bank & Trust Company (successor by purchase to the Federal Deposit Insurance Corporation as Receiver for Silicon Valley Bridge Bank, N.A. (as successor to Silicon Valley Bank)) (“Bank”) and Q32 Bio Inc., a Delaware corporation (“Borrower”) whose address is 830 Winter Street, Waltham, Massachusetts 02451.

RECITALS

A. Bank and Borrower have entered into that certain Loan and Security Agreement dated as of December 11, 2020, as amended by that certain First Amendment to Loan and Security Agreement by and between Borrower and Bank dated as of December 30, 2021, as further amended by that certain Second Amendment to Loan and Security Agreement by and between Borrower and Bank dated as of June 30, 2022, as amended by that certain Third Amendment to Loan and Security Agreement by and between Borrower and Bank dated as of August 10, 2022, as amended by that certain Fourth Amendment to Loan and Security Agreement by and between Borrower and Bank dated as of December 21, 2022 (the “Fourth Amendment”), and as further amended by that certain Fifth Amendment to Loan and Security Agreement by and between Borrower and Bank dated as of April 26, 2023 (as the same may from time to time be further amended, modified, supplemented or restated, the “Loan Agreement”).

B. Bank has extended credit to Borrower for the purposes permitted in the Loan Agreement.

C. Borrower has requested that Bank amend the Loan Agreement to (i) add a new term loan and (ii) make certain revisions to the Loan Agreement as more fully set forth herein.

D. Bank has agreed to so amend certain provisions of the Loan Agreement, but only to the extent, in accordance with the terms, subject to the conditions and in reliance upon the representations and warranties set forth below.

AGREEMENT

NOW, THEREFORE, in consideration of the foregoing recitals and other good and valuable consideration, the receipt and adequacy of which is hereby acknowledged, and intending to be legally bound, the parties hereto agree as follows:

1. Definitions. Capitalized terms used but not defined in this Amendment shall have the meanings given to them in the Loan Agreement.

2. Amendments to Loan Agreement.


2.1 Section 2.1.2 (2023 Term Loan Advances). The Loan Agreement is amended by inserting the following new Section 2.1.2 to appear immediately following Section 2.1.1 thereof:

“2.1.2 2023 Term Loan Advances.

(a) Availability. Subject to the terms and conditions of this Agreement, upon Borrower’s request, Bank shall make one (1) term loan advance (the “2023 Term A Loan Advance”) in an original principal amount of $5,500,000.00 on or about the Sixth Amendment Effective Date; provided that, all or a portion of the 2023 Term A Loan Advance shall be used to repay in full all of Borrower’s outstanding obligations and liabilities to Bank under the Term Loan Advances (including, the Final Payment, but for the avoidance of doubt the Prepayment Premium shall be waived pursuant to the terms of this Agreement) (the “Prior Obligations”). Borrower hereby authorizes Bank to apply the proceeds of the 2023 Term A Loan Advance to the Prior Obligations as part of the funding process without actually depositing such funds in an account of Borrower. Subject to the terms and conditions of this Agreement, during the 2023 Draw Period B, upon Borrower’s request, Bank shall make one (1) term loan advance (the “2023 Term B Loan Advance”) available to Borrower in an original principal amount of $7,000,000.00. Subject to the terms and conditions of this Agreement, during the 2023 Draw Period C, upon Borrower’s request, Bank shall make one (1) term loan advance (the “2023 Term C Loan Advance”) available to Borrower in an original principal amount of $7,500,000.00. Subject to the terms and conditions of this Agreement, during the 2023 Draw Period D, upon Borrower’s request, Bank shall make one (1) term loan advance (the “2023 Term D Loan Advance”) available to Borrower in an original principal amount of $5,000,000.00). The 2023 Term A Loan Advance, the 2023 Term B Loan Advance, the 2023 Term C Loan Advance, and the 2023 Term D Loan Advance are each hereinafter referred to singly as a “2023 Term Loan Advance” and collectively as the “2023 Term Loan Advances”. After repayment, no 2023 Term Loan Advance (or any portion thereof) may be reborrowed.

(b) Interest Period. Commencing on the first (1st) Payment Date of the month following the month in which the Funding Date of the applicable 2023 Term Loan Advance occurs, and continuing on each Payment Date thereafter, Borrower shall make monthly payments of interest on the principal amount of each 2023 Term Loan Advance at the rate set forth in Section 2.2(a).

(c) Repayment. Commencing on the 2023 Term Loan Amortization Date, and continuing on each Payment Date thereafter, Borrower shall repay the aggregate outstanding 2023 Term Loan Advances in (i) consecutive equal monthly installments of principal according to the 2023 Repayment Schedule, plus (ii) monthly payments of accrued interest at the rate set forth in Section 2.2(a). All outstanding principal and accrued and unpaid interest with respect to the 2023 Term Loan Advances, and all other outstanding Obligations with respect to the 2023 Term Loan Advances, are due and payable in full on the 2023 Term Loan Maturity Date.


(d) Mandatory Prepayment Upon an Acceleration. If the 2023 Term Loan Advances are accelerated by Bank following the occurrence and during the continuance of an Event of Default, Borrower shall immediately pay to Bank an amount equal to the sum of: (i) all outstanding principal plus accrued and unpaid interest with respect to the 2023 Term Loan Advances, plus (ii) the 2023 Prepayment Premium, (iii) the 2023 Final Payment, and (iv) all other sums, if any, that shall have become due and payable with respect to the 2023 Term Loan Advances, including interest at the Default Rate with respect to any past due amounts.

(e) Permitted Prepayment of 2023 Term Loan Advances. Borrower shall have the option to prepay all, but not less than all, of the 2023 Term Loan Advances advanced by Bank under this Agreement, provided Borrower (i) provides written notice to Bank of its election to prepay the 2023 Term Loan Advances at least five (5) days prior to such prepayment, and (ii) pays, on the date of such prepayment (A) all outstanding principal plus accrued and unpaid interest with respect to the 2023 Term Loan Advances, (B) the 2023 Prepayment Premium, (C) the 2023 Final Payment, and (D) all other sums, if any, that shall have become due and payable with respect to the 2023 Term Loan Advances, including interest at the Default Rate with respect to any past due amounts.”

2.2 Section 2.2(a) (Interest Rate). Section 2.2(a) is amended in its entirety and replaced with the following:

“(a) Interest Rate. Subject to Section 2.2(b), the principal amount outstanding under each 2023 Term Loan Advance shall accrue interest at a floating per annum rate equal to the greater of (A) the Prime Rate minus 0.25% and (B) 8.0%, which interest, in each case, shall be payable monthly in accordance with Section 2.2(d) below.

2.3 Section 2.3 (Fees). Section 2.3 is amended by (i) deleting the word “and” appearing at the end of subsection (c) thereof, (ii) deleting the “.” appearing at the end of subsection (d) thereof and inserting in lieu thereof “;”, and (iii) inserting the following new subsections (e) and (f) to appear immediately following subsection (d) thereof:

“(e) 2023 Prepayment Premium. The 2023 Prepayment Premium, if and when due hereunder; and

(f) 2023 Final Payment. The 2023 Final Payment, when due hereunder.”

2.4 Section 6.2 (Financial Statements, Reports). Section 6.2 is amended by (i) deleting the word “and” appearing at the end of clause (h), (ii) deleting the “.” appearing at the end of clause (i) and inserting in lieu thereof “; and”, and (iii) inserting the following new clause (j) to appear immediately following clause (m) thereof:

“(j) Detailed Cash Report. As soon as available, but no later than 30 days after the last day of each month, a detailed cash report, including monthly bank statements, setting forth each of Borrower’s, its Subsidiaries’, and any Guarantor’s accounts maintained outside of Bank and Bank’s Affiliates, and the balances maintained in such accounts as of the last day of such month, in a form reasonably acceptable to Bank.”


2.5 Section 6.6(a) (Accounts). Section 6.6(a) is amended in its entirety and replaced with the following:

“(a) Commencing as of the Fifth Amendment Effective Date, maintain the Collateral Money Market Account, and a portion of Borrower’s, any of its Subsidiaries’ (excluding Securities Corporation), and any Guarantor’s primary operating accounts, depository accounts and excess cash with Bank; provided that, (i) at all times when Borrower’s, its Subsidiaries’ and any Guarantor’s cash wherever located is less than or equal to $70,000,000.00, account balances in the name of Borrower and Securities Corporation at Bank shall represent at least 75.0% of Borrower’s, its Subsidiaries’ and any Guarantor’s cash wherever located and (ii) at all times when Borrower’s, its Subsidiaries’ and any Guarantor’s cash wherever located is greater than $70,000,000.00, account balances in the name of Borrower and Securities Corporation at Bank shall represent at least 50.0% of Borrower’s, its Subsidiaries’ and any Guarantor’s cash wherever located. In addition to the foregoing, Borrower shall at all times have on deposit in operating and depository accounts maintained in the name of Borrower with Bank, unrestricted and unencumbered cash in an amount equal to the lesser of (x) one hundred percent (100.0%) of the Dollar value of Borrower’s consolidated cash, including any Subsidiaries’, Affiliates’, or related entities’ cash, in the aggregate, wherever located, and (y) one hundred ten percent (110.0%) of the then- outstanding Obligations of Borrower to Bank. So long as, in each case, Borrower is in compliance with the terms of this Section 6.6(a) hereof, Borrower shall be permitted to maintain accounts with other banks or financial institutions (other than Bank) (the “Permitted Accounts”); provided that such Permitted Accounts shall be subject to a Control Agreement in favor of Bank pursuant to the terms of Sections 6.6(b) and 6.11 hereof.”

2.6 Section 6.12 (Cash Collateralization). Section 6.12 is amended in its entirety and replaced with the following:

“6.12 Cash Collateralization. As of the Third Amendment Effective Date, Borrower shall deposit and maintain at all times, in the Collateral Money Market Account unrestricted and unencumbered cash in an amount equal to $5,000,000.00 to secure the outstanding principal amount of the Term Loan Advances (a “Cash Collateralization”). Borrower hereby authorizes and directs Bank to transfer to the Collateral Money Market Account an amount equal to $5,000,000.00, if Borrower fails to effect a Cash Collateralization as required under this Section 6.12. Borrower further authorizes Bank, at the election of Bank, in Bank’s sole and absolute discretion upon the occurrence and during the continuance


of an Event of Default, to apply the funds held in the Collateral Money Market Account on account of the outstanding Obligations of Borrower to Bank (the “Paydown Payment”). Upon the occurrence of the 2023 Term B Milestone Event, Bank shall transfer all funds in the Collateral Money Market Account into Borrower’s operating account maintained at Bank, and this Section 6.12 shall have no further force or effect.”

2.7 Section 8.1 (Payment Default). Section 8.1 is amended by deleting the words “Term Loan Maturity Date” and inserting in lieu thereof the words “2023 Term Loan Maturity Date”.

2.8 Section 12.1 (Termination Prior to Term Loan Maturity Date; Survival). Section 12.1 is amended by deleting the words “Term Loan Maturity Date” in each case that they appear, and in each case inserting in lieu thereof the words “2023 Term Loan Maturity Date”.

2.9 Section 12.2 (Successors and Assigns). Section 12.2 is amended by inserting the words “and 2023 Warrant” to appear immediately following the words “the Warrant” appearing therein.

2.10 Section 13.1 (Definitions). The following terms and their respective definitions appearing in Section 13.1 are amended in their entirety and replaced with the following:

“ “Cash Pledge Agreement” is that certain Cash Pledge Agreement dated as of the Third Amendment Effective Date executed by Borrower in favor of Bank, as amended by that certain Rider to Cash Pledge Agreement by and between Borrower and Bank dated as of the Sixth Amendment Effective Date.”

“ “Credit Extension” is any Term Loan Advance, 2023 Term Loan Advance or any other extension of credit by Bank for Borrower’s benefit.”

“ “Loan Documents” are, collectively, this Agreement and any schedules, exhibits, certificates, notices, and any other documents related to this Agreement, the Warrant, the 2023 Warrant, the Cash Pledge Agreement, the Perfection Certificate, the Stock Pledge Agreement, any Control Agreement, any Bank Services Agreement, any subordination agreement, any note, or notes or guaranties executed by Borrower, and any other present or future agreement by Borrower with or for the benefit of Bank in connection with this Agreement or Bank Services, all as amended, restated, or otherwise modified.”

“ “Obligations” are Borrower’s obligations to pay when due any debts, principal, interest, fees, Bank Expenses, the Prepayment Premium, the Final Payment, the 2023 Prepayment Premium, the 2023 Final Payment and other amounts Borrower owes Bank now or later, whether under this Agreement, the other Loan Documents (other than the Warrant and the 2023 Warrant), or otherwise, including, without limitation, all obligations relating to Bank Services and any interest accruing after Insolvency Proceedings begin and debts, liabilities, or obligations of Borrower assigned to Bank, and to perform Borrower’s duties under the Loan Documents (other than the Warrant and the 2023 Warrant).”


2.11 Section 13.1 (Definitions). The Loan Agreement is amended by inserting the following new defined terms and their respective definitions to appear alphabetically in Section 13.1 thereof:

“ “2023 Draw Period B” is the period of time commencing upon the occurrence of 2023 Term B Milestone Event and continuing through the earlier to occur of (a) March 31, 2024, or (b) an Event of Default.”

“ “2023 Draw Period C” is the period of time commencing upon the occurrence of 2023 Term C Milestone Event and continuing through the earlier to occur of (a) March 31, 2025, or (b) an Event of Default.”

“ “2023 Draw Period D” is the period of time commencing upon the occurrence of 2023 Term D Milestone Event and continuing through the earlier to occur of (a) the 2023 Draw Period D End Date, or (b) an Event of Default.”

“ “2023 Draw Period D End Date” means the earlier to occur of (i) March 31, 2025 or (ii) the day which is immediately prior to the 2023 Term Loan Amortization Date.

“ “2023 Final Payment” is a payment (in addition to and not a substitution for the regular monthly payments of principal plus accrued interest) due on the earliest to occur of (a) the 2023 Term Loan Maturity Date, (b) the repayment of the 2023 Term Loan Advances in full, (c) as required pursuant to Sections 2.1.2(d) or 2.1.2(e), or (d) the termination of this Agreement, in an amount equal to the aggregate original principal amount of the 2023 Term Loan Advances extended by Bank to Borrower multiplied by 3.50%.

“ “2023 Prepayment Premium” shall be an additional fee, payable to Bank, with respect to the 2023 Term Loan Advances, in an amount equal to:

(a) for a prepayment of the 2023 Term Loan Advances made on or prior to the first (1st) anniversary of the Sixth Amendment Effective Date, 3.50% of the then-outstanding principal amount of the 2023 Term Loan Advances immediately prior to the date of such prepayment;

(b) for a prepayment of the 2023 Term Loan Advances made after the first (1st) anniversary of the Sixth Amendment Effective Date, but on or prior to the second (2nd) anniversary of the Sixth Amendment Effective Date, 2.0% of the then- outstanding principal amount of the 2023 Term Loan Advances immediately prior to the date of such prepayment; and


(c) for a prepayment of the 2023 Term Loan Advances made after the second (2nd) anniversary of the Sixth Amendment Effective Date, but prior to the 2023 Term Loan Maturity Date, 1.00% of the then-outstanding principal amount of the 2023 Term Loan Advances immediately prior to the date of such prepayment.

Notwithstanding the foregoing, provided no Event of Default has occurred and is continuing, the 2023 Prepayment Premium shall be waived by Bank, if Bank closes on the refinance and redocumentation of the 2023 Term Loan Advances (in its sole and absolute discretion) prior to the 2023 Term Loan Maturity Date.”

“ “2023 Term A Loan Advance” is defined in Section 2.1.2(a).”

“ “2023 Term B Loan Advance” is defined in Section 2.1.2(a).”

“ “2023 Term B Milestone Event” occurs if and when (if ever) Bank confirms in writing that it has received evidence satisfactory to Bank in its sole and absolute discretion, on or prior to September 30, 2023, that Borrower has received, after the Sixth Amendment Effective Date, but on or prior to September 30, 2023, unrestricted and unencumbered net cash proceeds of at least $75,000,000.00 from the issuance and sale of its equity securities to investors satisfactory to Bank.”

“ “2023 Term C Milestone Event” occurs if and when (if ever) Bank confirms in writing, on or prior to December 31, 2024, that (a) the 2023 Term B Milestone Event has occurred, (b) the Positive Data Event has occurred, and (c) the Second Equity Event has occurred.”

“ “2023 Term D Milestone Event” occurs if and when (if ever), if at any time prior to March 31, 2025, Bank confirms in writing that: (a) Borrower has requested the 2023 Term D Loan Advance, (b) Bank has received all necessary internal and credit approvals to make the 2023 Term D Loan Advance, (c) no Event of Default exists at the time the 2023 Term D Loan Advance is requested or would exist as a result of the 2023 Term D Loan Advance, and (d) Bank has provided written approval in its sole discretion that the 2023 Term D Loan Advance shall occur.

“ “2023 Term C Loan Advance” is defined in Section 2.1.2(a).”

“ “2023 Term D Loan Advance” is defined in Section 2.1.2(a).”

“ “2023 Term Loan Advance” and “2023 Term Loan Advances” are each defined in Section 2.1.2(a).”

“ “2023 Term Loan Amortization Date” means July 1, 2024, which shall be extended to January 1, 2025 upon the occurrence of the Positive Data Event, which shall be further extended until July 1, 2025 upon the occurrence of the 2023 Term C Milestone Event.”

“ “2023 Term Loan Maturity Date” is June 1, 2027.”


“ “2023 Repayment Schedule” means the period of time equal to 36 consecutive calendar months, which shall be reduced to 30 consecutive calendar months upon the occurrence of the Positive Data Event, which shall be further reduced to 24 consecutive calendar months upon the occurrence of the 2023 Term C Milestone Event.”

“ “2023 Warrant” is that certain Warrant to Purchase Stock dated as of the Sixth Amendment Effective Date between Borrower and Bank, as amended, modified, supplemented and/or restated from time to time.”

“ “Positive Data Event” occurs if and when (if ever) Bank confirms in writing that, it has received, on or prior to June 30, 2024, evidence satisfactory to Bank in its sole and absolute discretion (which evidence shall include satisfactory discussions between Bank and Borrower’s investors), that Borrower has received positive interim phase 2 data for ADX-097.”

“ “Second Equity Event” occurs if and when (if ever) Bank confirms in writing that it has received evidence satisfactory to Bank in its sole and absolute discretion, on or prior to December 31, 2024, that Borrower has received, after the Sixth Amendment Effective Date, but on or prior to December 31, 2024, unrestricted and unencumbered net cash proceeds of at least $75,000,000.00 from the issuance and sale of its equity securities to investors satisfactory to Bank (which proceeds shall not include any proceeds received in connection with the 2023 Term B Milestone Event).”

“ “Sixth Amendment Effective Date” is July 12, 2023.”

2.12 Exhibit B (Compliance Statement). The Compliance Statement is amended in its entirety and replaced with the Compliance Statement in the form of Schedule 1 attached hereto.

3. Limitation of Amendments.

3.1 The amendments set forth in Section 2 above are effective for the purposes set forth herein and shall be limited precisely as written and shall not be deemed to (a) be a consent to any amendment, waiver or modification of any other term or condition of any Loan Document, or (b) otherwise prejudice any right or remedy which Bank may now have or may have in the future under or in connection with any Loan Document.

3.2 This Amendment shall be construed in connection with and as part of the Loan Documents and all terms, conditions, representations, warranties, covenants and agreements set forth in the Loan Documents, except as herein amended, are hereby ratified and confirmed and shall remain in full force and effect.


4. Representations and Warranties. To induce Bank to enter into this Amendment, Borrower hereby represents and warrants to Bank as follows:

4.1 Immediately after giving effect to this Amendment (a) the representations and warranties contained in the Loan Documents are true, accurate and complete in all material respects as of the date hereof (except to the extent such representations and warranties relate to an earlier date, in which case they are true and correct in all material respects as of such date), and (b) no Event of Default has occurred and is continuing;

4.2 Borrower has the power and authority to execute and deliver this Amendment and to perform its obligations under the Loan Agreement, as amended by this Amendment;

4.3 The organizational documents of Borrower delivered to Bank on December 11, 2020 remain true, accurate and complete and have not been amended, supplemented or restated and are and continue to be in full force and effect;

4.4 The execution and delivery by Borrower of this Amendment and the performance by Borrower of its obligations under the Loan Agreement, as amended by this Amendment, have been duly authorized;

4.5 The execution and delivery by Borrower of this Amendment and the performance by Borrower of its obligations under the Loan Agreement, as amended by this Amendment, do not and will not contravene (a) any law or regulation binding on or affecting Borrower, (b) any contractual restriction with a Person binding on Borrower, (c) any order, judgment or decree of any court or other governmental or public body or authority, or subdivision thereof, binding on Borrower, or (d) the organizational documents of Borrower;

4.6 The execution and delivery by Borrower of this Amendment and the performance by Borrower of its obligations under the Loan Agreement, as amended by this Amendment, do not require any order, consent, approval, license, authorization or validation of, or filing, recording or registration with, or exemption by any governmental or public body or authority, or subdivision thereof, binding on Borrower, except as already has been obtained or made; and

4.7 This Amendment has been duly executed and delivered by Borrower and is the binding obligation of Borrower, enforceable against Borrower in accordance with its terms, except as such enforceability may be limited by bankruptcy, insolvency, reorganization, liquidation, moratorium or other similar laws of general application relating to or affecting creditors’ rights and by general equitable principles.

5. Release by Borrower:

5.1 FOR GOOD AND VALUABLE CONSIDERATION, Borrower hereby forever relieves, releases, and discharges Bank and its present or former employees, officers, directors, agents, representatives, attorneys, and each of them, from any and all claims, debts, liabilities, demands, obligations, promises, acts, agreements, costs and expenses, actions and causes of action, of every type, kind, nature, description or character whatsoever, whether known or unknown, suspected or unsuspected, absolute or contingent, arising out of or in any manner whatsoever connected with or related to facts, circumstances, issues, controversies or claims existing or arising from the beginning of time through and including the date of execution of this


Amendment (collectively “Released Claims”). Without limiting the foregoing, the Released Claims shall include any and all liabilities or claims arising out of or in any manner whatsoever connected with or related to the Loan Documents, the recitals hereto, any instruments, agreements or documents executed in connection with any of the foregoing or the origination, negotiation, administration, servicing and/or enforcement of any of the foregoing.

5.2 In furtherance of this release, Borrower expressly acknowledges and waives any and all rights under Section 1542 of the California Civil Code, which provides as follows:

“A general release does not extend to claims that the creditor or releasing party does not know or suspect to exist in his or her favor at the time of executing the release and that, if known by him or her, would have materially affected his or her settlement with the debtor or released party.” (Emphasis added.)

5.3 By entering into this release, Borrower recognizes that no facts or representations are ever absolutely certain and it may hereafter discover facts in addition to or different from those which it presently knows or believes to be true, but that it is the intention of Borrower hereby to fully, finally and forever settle and release all matters, disputes and differences, known or unknown, suspected or unsuspected; accordingly, if Borrower should subsequently discover that any fact that it relied upon in entering into this release was untrue, or that any understanding of the facts was incorrect, Borrower shall not be entitled to set aside this release by reason thereof, regardless of any claim of mistake of fact or law or any other circumstances whatsoever. Borrower acknowledges that it is not relying upon and has not relied upon any representation or statement made by Bank with respect to the facts underlying this release or with regard to any of such party’s rights or asserted rights.

5.4 This release may be pleaded as a full and complete defense and/or as a cross-complaint or counterclaim against any action, suit, or other proceeding that may be instituted, prosecuted or attempted in breach of this release. Borrower acknowledges that the release contained herein constitutes a material inducement to Bank to enter into this Amendment, and that Bank would not have done so but for Bank’s expectation that such release is valid and enforceable in all events.

5.5 Borrower hereby represents and warrants to Bank, and Bank is relying thereon, as follows:

(a) Except as expressly stated in this Amendment, neither Bank nor any agent, employee or representative of Bank has made any statement or representation to Borrower regarding any fact relied upon by Borrower in entering into this Amendment.

(b) Borrower has made such investigation of the facts pertaining to this Amendment and all of the matters appertaining thereto, as it deems necessary.

(c) The terms of this Amendment are contractual and not a mere recital.

(d) This Amendment has been carefully read by Borrower, the contents hereof are known and understood by Borrower, and this Amendment is signed freely, and without duress, by Borrower.


(e) Borrower represents and warrants that it is the sole and lawful owner of all right, title and interest in and to every claim and every other matter which it releases herein, and that it has not heretofore assigned or transferred, or purported to assign or transfer, to any person, firm or entity any claims or other matters herein released. Borrower shall indemnify Bank, defend and hold it harmless from and against all claims based upon or arising in connection with prior assignments or purported assignments or transfers of any claims or matters released herein.

6. Post-Closing Conditions. Within 30 days after the Sixth Amendment Effective Date, Borrower shall deliver to Bank evidence satisfactory to Bank that the insurance policies and endorsements required by Section 6.5 of the Loan Agreement are in full force and effect, together with appropriate evidence showing lender loss payable and/or additional insured clauses or endorsements in favor of Bank.

7. Ratification of Perfection Certificate. Borrower hereby ratifies, confirms and reaffirms, all and singular, the terms and disclosures contained in a certain Perfection Certificate of Borrower dated as of December 30, 2021, and acknowledges, confirms and agrees that the disclosures and information Borrower provided to Bank in said Perfection Certificate have not changed, as of the date hereof, except as set forth on Schedule A to the Fourth Amendment.

8. Ratification of Stock Pledge Agreement. Borrower hereby ratifies, confirms and reaffirms, all and singular, the terms and disclosures contained in a certain Stock Pledge Agreement by and between Borrower and Bank dated as of December 11, 2020, and acknowledges, confirms and agrees that said Stock Pledge Agreement (a) contains an accurate and complete listing of all Shares (as such term is defined therein) and (b) shall remain in full force and effect.

9. Fees and Expenses. Borrower shall reimburse Bank for all unreimbursed Bank Expenses, including without limitation, all reasonable documented legal fees and expenses incurred in connection with this Amendment.

10. Governing Law. This Amendment shall be governed and construed in accordance with the laws of the Commonwealth of Massachusetts, without giving effect to conflicts of laws principles.

11. Integration. This Amendment and the Loan Documents represent the entire agreement about this subject matter and supersede prior negotiations or agreements. All prior agreements, understandings, representations, warranties, and negotiations between the parties about the subject matter of this Amendment and the Loan Documents merge into this Amendment and the Loan Documents.

12. Counterparts. This Amendment may be executed in any number of counterparts and all of such counterparts taken together shall be deemed to constitute one and the same instrument. Each party hereto may execute this Amendment by electronic means and recognizes and accepts the use of electronic signatures and records by any other party hereto in connection with the execution and storage hereof.

13. Effectiveness. This Amendment shall be deemed effective as of the due execution and delivery to Bank of this Amendment by each party hereto.


[Signature page follows.]


IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be duly executed and delivered as a sealed instrument under the laws of the Commonwealth of Massachusetts as of the date first written above.

 

BANK     BORROWER
FIRST-CITIZENS BANK & TRUST COMPANY (SUCCESSOR BY PURCHASE TO THE FEDERAL DEPOSIT INSURANCE CORPORATION AS RECEIVER FOR SILICON VALLEY BRIDGE BANK, N.A. (AS SUCCESSOR TO SILICON VALLEY BANK))     Q32 BIO INC.
By:   /s/ John Sansone     By:   /s/ Adam Cutler
Name:   John Sansone     Name:   Adam Cutler
Title:   Vice President     Title:   CFO and Treasurer

Exhibit 10.57

SEVENTH AMENDMENT

TO

LOAN AND SECURITY AGREEMENT

This Seventh Amendment to Loan and Security Agreement (this “Amendment”) is entered into this 2nd day of November, 2023 by and between Silicon Valley Bank, a division of First-Citizens Bank & Trust Company and Q32 Bio Inc., a Delaware corporation (“Borrower”) whose address is 830 Winter Street, Waltham, Massachusetts 02451.

RECITALS

A. Bank and Borrower have entered into that certain Loan and Security Agreement dated as of December 11, 2020, as amended by that certain First Amendment to Loan and Security Agreement by and between Borrower and Bank dated as of December 30, 2021, as further amended by that certain Second Amendment to Loan and Security Agreement by and between Borrower and Bank dated as of June 30, 2022, as amended by that certain Third Amendment to Loan and Security Agreement by and between Borrower and Bank dated as of August 10, 2022, as amended by that certain Fourth Amendment to Loan and Security Agreement by and between Borrower and Bank dated as of December 21, 2022 (the “Fourth Amendment”), as further amended by that certain Fifth Amendment to Loan and Security Agreement by and between Borrower and Bank dated as of April 26, 2023, and as further amended by that certain Fifth Amendment to Loan and Security Agreement by and between Borrower and Bank dated as of July 12, 2023 (as the same may from time to time be further amended, modified, supplemented or restated, the “Loan Agreement”).

B. Bank has extended credit to Borrower for the purposes permitted in the Loan Agreement.

C. Borrower has requested that Bank amend the Loan Agreement to make certain revisions to the Loan Agreement as more fully set forth herein.

D. Bank has agreed to so amend certain provisions of the Loan Agreement, but only to the extent, in accordance with the terms, subject to the conditions and in reliance upon the representations and warranties set forth below.

AGREEMENT

NOW, THEREFORE, in consideration of the foregoing recitals and other good and valuable consideration, the receipt and adequacy of which is hereby acknowledged, and intending to be legally bound, the parties hereto agree as follows:

1. Definitions. Capitalized terms used but not defined in this Amendment shall have the meanings given to them in the Loan Agreement.


2. Amendments to Loan Agreement.

2.1 Section 13.1 (Definitions). The following term and its respective definitions appearing in Section 13.1 is amended in its entirety and replaced with the following:

“ “2023 Term B Milestone Event” occurs if and when (if ever) Bank confirms in writing that it has received evidence satisfactory to Bank in its sole and absolute discretion, on or prior to March 31, 2024, that Borrower has received, after the Sixth Amendment Effective Date, but on or prior to March 31, 2024, unrestricted and unencumbered net cash proceeds of at least $75,000,000.00 from (a) the issuance and sale of its equity securities to investors satisfactory to Bank and/or (b) a business development transaction satisfactory to Bank; provided that, at least $37,500,000.00 of such net cash proceeds must be received from the issuance and sale of its equity securities to investors satisfactory to Bank.”

3. Limitation of Amendments.

3.1 The amendments set forth in Section 2 above are effective for the purposes set forth herein and shall be limited precisely as written and shall not be deemed to (a) be a consent to any amendment, waiver or modification of any other term or condition of any Loan Document, or (b) otherwise prejudice any right or remedy which Bank may now have or may have in the future under or in connection with any Loan Document.

3.2 This Amendment shall be construed in connection with and as part of the Loan Documents and all terms, conditions, representations, warranties, covenants and agreements set forth in the Loan Documents, except as herein amended, are hereby ratified and confirmed and shall remain in full force and effect.

4. Representations and Warranties. To induce Bank to enter into this Amendment, Borrower hereby represents and warrants to Bank as follows:

4.1 Immediately after giving effect to this Amendment (a) the representations and warranties contained in the Loan Documents are true, accurate and complete in all material respects as of the date hereof (except to the extent such representations and warranties relate to an earlier date, in which case they are true and correct in all material respects as of such date), and (b) no Event of Default has occurred and is continuing;

4.2 Borrower has the power and authority to execute and deliver this Amendment and to perform its obligations under the Loan Agreement, as amended by this Amendment;

4.3 The organizational documents of Borrower delivered to Bank on December 11, 2020 remain true, accurate and complete and have not been amended, supplemented or restated and are and continue to be in full force and effect;

4.4 The execution and delivery by Borrower of this Amendment and the performance by Borrower of its obligations under the Loan Agreement, as amended by this Amendment, have been duly authorized;

4.5 The execution and delivery by Borrower of this Amendment and the performance by Borrower of its obligations under the Loan Agreement, as amended by this Amendment, do not and will not contravene (a) any law or regulation binding on or affecting Borrower, (b) any contractual restriction with a Person binding on Borrower, (c) any order, judgment or decree of any court or other governmental or public body or authority, or subdivision thereof, binding on Borrower, or (d) the organizational documents of Borrower;


4.6 The execution and delivery by Borrower of this Amendment and the performance by Borrower of its obligations under the Loan Agreement, as amended by this Amendment, do not require any order, consent, approval, license, authorization or validation of, or filing, recording or registration with, or exemption by any governmental or public body or authority, or subdivision thereof, binding on Borrower, except as already has been obtained or made; and

4.7 This Amendment has been duly executed and delivered by Borrower and is the binding obligation of Borrower, enforceable against Borrower in accordance with its terms, except as such enforceability may be limited by bankruptcy, insolvency, reorganization, liquidation, moratorium or other similar laws of general application relating to or affecting creditors’ rights and by general equitable principles.

5. Release by Borrower:

5.1 FOR GOOD AND VALUABLE CONSIDERATION, Borrower hereby forever relieves, releases, and discharges Bank and its present or former employees, officers, directors, agents, representatives, attorneys, and each of them, from any and all claims, debts, liabilities, demands, obligations, promises, acts, agreements, costs and expenses, actions and causes of action, of every type, kind, nature, description or character whatsoever, whether known or unknown, suspected or unsuspected, absolute or contingent, arising out of or in any manner whatsoever connected with or related to facts, circumstances, issues, controversies or claims existing or arising from the beginning of time through and including the date of execution of this Amendment (collectively “Released Claims”). Without limiting the foregoing, the Released Claims shall include any and all liabilities or claims arising out of or in any manner whatsoever connected with or related to the Loan Documents, the recitals hereto, any instruments, agreements or documents executed in connection with any of the foregoing or the origination, negotiation, administration, servicing and/or enforcement of any of the foregoing.

5.2 In furtherance of this release, Borrower expressly acknowledges and waives any and all rights under Section 1542 of the California Civil Code, which provides as follows:

“A general release does not extend to claims that the creditor or releasing party does not know or suspect to exist in his or her favor at the time of executing the release and that, if known by him or her, would have materially affected his or her settlement with the debtor or released party.” (Emphasis added.)

5.3 By entering into this release, Borrower recognizes that no facts or representations are ever absolutely certain and it may hereafter discover facts in addition to or different from those which it presently knows or believes to be true, but that it is the intention of Borrower hereby to fully, finally and forever settle and release all matters, disputes and differences, known or unknown, suspected or unsuspected; accordingly, if Borrower should subsequently discover that any fact that it relied upon in entering into this release was untrue, or that any understanding of the facts was incorrect, Borrower shall not be entitled to set aside this release by


reason thereof, regardless of any claim of mistake of fact or law or any other circumstances whatsoever. Borrower acknowledges that it is not relying upon and has not relied upon any representation or statement made by Bank with respect to the facts underlying this release or with regard to any of such party’s rights or asserted rights.

5.4 This release may be pleaded as a full and complete defense and/or as a cross-complaint or counterclaim against any action, suit, or other proceeding that may be instituted, prosecuted or attempted in breach of this release. Borrower acknowledges that the release contained herein constitutes a material inducement to Bank to enter into this Amendment, and that Bank would not have done so but for Bank’s expectation that such release is valid and enforceable in all events.

5.5 Borrower hereby represents and warrants to Bank, and Bank is relying thereon, as follows:

(a) Except as expressly stated in this Amendment, neither Bank nor any agent, employee or representative of Bank has made any statement or representation to Borrower regarding any fact relied upon by Borrower in entering into this Amendment.

(b) Borrower has made such investigation of the facts pertaining to this Amendment and all of the matters appertaining thereto, as it deems necessary.

(c) The terms of this Amendment are contractual and not a mere recital.

(d) This Amendment has been carefully read by Borrower, the contents hereof are known and understood by Borrower, and this Amendment is signed freely, and without duress, by Borrower.

(e) Borrower represents and warrants that it is the sole and lawful owner of all right, title and interest in and to every claim and every other matter which it releases herein, and that it has not heretofore assigned or transferred, or purported to assign or transfer, to any person, firm or entity any claims or other matters herein released. Borrower shall indemnify Bank, defend and hold it harmless from and against all claims based upon or arising in connection with prior assignments or purported assignments or transfers of any claims or matters released herein.

6. Ratification of Perfection Certificate. Borrower hereby ratifies, confirms and reaffirms, all and singular, the terms and disclosures contained in a certain Perfection Certificate of Borrower dated as of August 23, 2023, and acknowledges, confirms and agrees that the disclosures and information Borrower provided to Bank in said Perfection Certificate have not changed, as of the date hereof.

7. Ratification of Stock Pledge Agreement. Borrower hereby ratifies, confirms and reaffirms, all and singular, the terms and disclosures contained in a certain Stock Pledge Agreement by and between Borrower and Bank dated as of December 11, 2020, and acknowledges, confirms and agrees that said Stock Pledge Agreement (a) contains an accurate and complete listing of all Shares (as such term is defined therein) and (b) shall remain in full force and effect.


8. Fees and Expenses. Borrower shall reimburse Bank for all unreimbursed Bank Expenses, including without limitation, all reasonable documented legal fees and expenses incurred in connection with this Amendment.

9. Governing Law. This Amendment shall be governed and construed in accordance with the laws of the Commonwealth of Massachusetts, without giving effect to conflicts of laws principles.

10. Integration. This Amendment and the Loan Documents represent the entire agreement about this subject matter and supersede prior negotiations or agreements. All prior agreements, understandings, representations, warranties, and negotiations between the parties about the subject matter of this Amendment and the Loan Documents merge into this Amendment and the Loan Documents.

11. Counterparts. This Amendment may be executed in any number of counterparts and all of such counterparts taken together shall be deemed to constitute one and the same instrument. Each party hereto may execute this Amendment by electronic means and recognizes and accepts the use of electronic signatures and records by any other party hereto in connection with the execution and storage hereof.

12. Effectiveness. This Amendment shall be deemed effective as of the due execution and delivery to Bank of this Amendment by each party hereto.

[Signature page follows.]


IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be duly executed and delivered as a sealed instrument under the laws of the Commonwealth of Massachusetts as of the date first written above.

 

BANK

    BORROWER
FIRST-CITIZENS BANK & TRUST COMPANY     Q32 BIO INC.
By:   /s/ Jameson Whiteley     By:   /s/ Jodie Morrison
Name: Jameson Whiteley     Name: Jodie Morrison
Title: Vice President     Title: President and Chief Executive Officer

Exhibit 10.58

ADMIRX INC.

2017 STOCK OPTION AND GRANT PLAN

 

SECTION 1.

GENERAL PURPOSE OF THE PLAN; DEFINITIONS

The name of the plan is the AdMIRx Inc. 2017 Stock Option and Grant Plan (the “Plan”).

The purpose of the Plan is to encourage and enable the officers, employees, directors, Consultants and other key persons of AdMIRx Inc., a Delaware corporation (including any successor entity, the “Company”) and its Subsidiaries, upon whose judgment, initiative and efforts the Company largely depends for the successful conduct of its business, to acquire a proprietary interest in the Company.

The following terms shall be defined as set forth below:

“Affiliate” of any Person means a Person that directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with the first mentioned Person. A Person shall be deemed to control another Person if such first Person possesses directly or indirectly the power to direct, or cause the direction of, the management and policies of the second Person, whether through the ownership of voting securities, by contract or otherwise.

“Award” or “Awards,” except where referring to a particular category of grant under the Plan, shall include Incentive Stock Options, NonQualified Stock Options, Restricted Stock Awards, Unrestricted Stock Awards, Restricted Stock Units or any combination of the foregoing.

“Award Agreement” means a written or electronic agreement setting forth the terms and provisions applicable to an Award granted under the Plan. Each Award Agreement may contain terms and conditions in addition to those set forth in the Plan; provided, however, in the event of any conflict in the terms of the Plan and the Award Agreement, the terms of the Plan shall govern.

“Board” means the Board of Directors of the Company.

“Cause” shall have the meaning as set forth in the Award Agreement(s). In the case that any Award Agreement does not contain a definition of “Cause,” it shall mean (i) the grantee’s dishonest statements or acts with respect to the Company or any Affiliate of the Company, or any current or prospective customers, suppliers vendors or other third parties with which such entity does business; (ii) the grantee’s commission of (A) a felony or (B) any misdemeanor involving moral turpitude, deceit, dishonesty or fraud; (iii) the grantee’s failure to perform his assigned duties and responsibilities to the reasonable satisfaction of the Company which failure continues, in the reasonable judgment of the Company, after written notice given to the grantee by the Company; (iv) the grantee’s gross negligence, willful misconduct or insubordination with respect to the Company or any Affiliate of the Company; or (v) the grantee’s material violation of any provision of any agreement(s) between the grantee and the Company relating to noncompetition, nonsolicitation, nondisclosure and/or assignment of inventions.


“Chief Executive Officer” means the Chief Executive Officer of the Company or, if there is no Chief Executive Officer, then the President of the Company.

“Code” means the Internal Revenue Code of 1986, as amended, and any successor Code, and related rules, regulations and interpretations.

“Committee” means the Committee of the Board referred to in Section 2.

“Consultant” means any natural person that provides bona fide services to the Company (including a Subsidiary), and such services are not in connection with the offer or sale of securities in a capital-raising transaction and do not directly or indirectly promote or maintain a market for the Company’s securities.

“Disability” means “disability” as defined in Section 422(c) of the Code.

“Effective Date” means the date on which the Plan is adopted as set forth on the final page of the Plan.

“Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder.

“Fair Market Value” of the Stock on any given date means the fair market value of the Stock determined in good faith by the Committee based on the reasonable application of a reasonable valuation method not inconsistent with Section 409A of the Code. If the Stock is admitted to trade on a national securities exchange, the determination shall be made by reference to the closing price reported on such exchange. If there is no closing price for such date, the determination shall be made by reference to the last date preceding such date for which there is a closing price. If the date for which Fair Market Value is determined is the first day when trading prices for the Stock are reported on a national securities exchange, the Fair Market Value shall be the “Price to the Public” (or equivalent) set forth on the cover page for the final prospectus relating to the Company’s Initial Public Offering.

“Good Reason” shall have the meaning as set forth in the Award Agreement(s). In the case that any Award Agreement does not contain a definition of “Good Reason,” it shall mean (i) a material diminution in the grantee’s base salary except for across-the-board salary reductions similarly affecting all or substantially all similarly situated employees of the Company or (ii) a change of more than 50 miles in the geographic location at which the grantee provides services to the Company, so long as the grantee provides at least 90 days notice to the Company following the initial occurrence of any such event and the Company fails to cure such event within 30 days thereafter.

“Grant Date” means the date that the Committee designates in its approval of an Award in accordance with applicable law as the date on which the Award is granted, which date may not precede the date of such Committee approval.

“Holder” means, with respect to an Award or any Shares, the Person holding such Award or Shares, including the initial recipient of the Award or any Permitted Transferee.

 

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“Incentive Stock Option” means any Stock Option designated and qualified as an “incentive stock option” as defined in Section 422 of the Code.

“Initial Public Offering” means the consummation of the first firm commitment underwritten public offering pursuant to an effective registration statement under the Securities Act covering the offer and sale by the Company of its equity securities, as a result of or following which the Stock shall be publicly held.

“Non-Qualified Stock Option” means any Stock Option that is not an Incentive Stock Option.

“Option” or “Stock Option” means any option to purchase shares of Stock granted pursuant to Section 5.

“Permitted Transferees” shall mean any of the following to whom a Holder may transfer Shares hereunder (as set forth in Section 9(a)(ii)(A)): the Holder’s child, stepchild, grandchild, parent, stepparent, grandparent, spouse, former spouse, sibling, niece, nephew, mother-in-law, father-in-law, son-in-law, daughter-in-law, brother-in-law, or sister-in-law, including adoptive relationships, any person sharing the Holder’s household (other than a tenant or employee), a trust in which these persons have more than fifty percent of the beneficial interest, a foundation in which these persons control the management of assets, and any other entity in which these persons own more than fifty percent of the voting interests; provided, however, that any such trust does not require or permit distribution of any Shares during the term of the Award Agreement unless subject to its terms. Upon the death of the Holder, the term Permitted Transferees shall also include such deceased Holder’s estate, executors, administrators, personal representatives, heirs, legatees and distributees, as the case may be.

“Person” shall mean any individual, corporation, partnership (limited or general), limited liability company, limited liability partnership, association, trust, joint venture, unincorporated organization or any similar entity.

“Restricted Stock Award” means Awards granted pursuant to Section 6 and “Restricted Stock” means Shares issued pursuant to such Awards.

“Restricted Stock Unit” means an Award of phantom stock units to a grantee, which may be settled in cash or Shares as determined by the Committee, pursuant to Section 8.

“Sale Event” means the consummation of (i) the dissolution or liquidation of the Company, (ii) the sale of all or substantially all of the assets of the Company on a consolidated basis to an unrelated person or entity, (iii) a merger, reorganization or consolidation pursuant to which the holders of the Company’s outstanding voting power immediately prior to such transaction do not own a majority of the outstanding voting power of the surviving or resulting entity (or its ultimate parent, if applicable), (iv) the acquisition of all or a majority of the outstanding voting stock of the Company in a single transaction or a series of related transactions by a Person or group of Persons, or (v) any other acquisition of the business of the Company, as determined by the Board; provided, however, that the Company’s Initial Public Offering, any subsequent public offering or another capital raising event, or a merger effected solely to change the Company’s domicile shall not constitute a “Sale Event.”

 

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“Section 409A” means Section 409A of the Code and the regulations and other guidance promulgated thereunder.

“Securities Act” means the Securities Act of 1933, as amended, and the rules and regulations thereunder.

“Service Relationship” means any relationship as a full-time employee, part-time employee, director or other key person (including Consultants) of the Company or any Subsidiary or any successor entity (e.g., a Service Relationship shall be deemed to continue without interruption in the event an individual’s status changes from full-time employee to part-time employee or Consultant).

“Shares” means shares of Stock.

“Stock” means the Common Stock, par value $0.0001 per share, of the Company. “Subsidiary” means any corporation or other entity (other than the Company) in which

the Company has more than a 50 percent interest, either directly or indirectly.

“Ten Percent Owner” means an employee who owns or is deemed to own (by reason of the attribution rules of Section 424(d) of the Code) more than 10 percent of the combined voting power of all classes of stock of the Company or any parent of the Company or any Subsidiary.

“Termination Event” means the termination of the Award recipient’s Service Relationship with the Company and its Subsidiaries for any reason whatsoever, regardless of the circumstances thereof, and including, without limitation, upon death, disability, retirement, discharge or resignation for any reason, whether voluntarily or involuntarily. The following shall not constitute a Termination Event: (i) a transfer to the service of the Company from a Subsidiary or from the Company to a Subsidiary, or from one Subsidiary to another Subsidiary or

(ii) an approved leave of absence for military service or sickness, or for any other purpose approved by the Committee, if the individual’s right to re-employment is guaranteed either by a statute or by contract or under the policy pursuant to which the leave of absence was granted or if the Committee otherwise so provides in writing.

“Unrestricted Stock Award” means any Award granted pursuant to Section 7 and

“Unrestricted Stock” means Shares issued pursuant to such Awards.

 

SECTION 2.

ADMINISTRATION OF PLAN; COMMITTEE AUTHORITY TO SELECT GRANTEES AND DETERMINE AWARDS

(a)    Administration of Plan. The Plan shall be administered by the Board, or at the discretion of the Board, by a committee of the Board, comprised of not less than two directors. All references herein to the “Committee” shall be deemed to refer to the group then responsible for administration of the Plan at the relevant time (i.e., either the Board of Directors or a committee or committees of the Board, as applicable).

(b)    Powers of Committee. The Committee shall have the power and authority to grant Awards consistent with the terms of the Plan, including the power and authority:

 

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(i)    to select the individuals to whom Awards may from time to time be granted;

(ii)    to determine the time or times of grant, and the amount, if any, of Incentive Stock Options, NonQualified Stock Options, Restricted Stock Awards, Unrestricted Stock Awards, Restricted Stock Units, or any combination of the foregoing, granted to any one or more grantees;

(iii)    to determine the number of Shares to be covered by any Award and, subject to the provisions of the Plan, the price, exercise price, conversion ratio or other price relating thereto;

(iv)    to determine and, subject to Section 12, to modify from time to time the terms and conditions, including restrictions, not inconsistent with the terms of the Plan, of any Award, which terms and conditions may differ among individual Awards and grantees, and to approve the form of Award Agreements;

(v)    to accelerate at any time the exercisability or vesting of all or any portion of any Award;

(vi)    to impose any limitations on Awards, including limitations on transfers, repurchase provisions and the like, and to exercise repurchase rights or obligations;

(vii)    subject to Section 5(a)(ii) and any restrictions imposed by Section 409A, to extend at any time the period in which Stock Options may be exercised; and

(viii)    at any time to adopt, alter and repeal such rules, guidelines and practices for administration of the Plan and for its own acts and proceedings as it shall deem advisable; to interpret the terms and provisions of the Plan and any Award (including Award Agreements); to make all determinations it deems advisable for the administration of the Plan; to decide all disputes arising in connection with the Plan; and to otherwise supervise the administration of the Plan.

All decisions and interpretations of the Committee shall be binding on all persons, including the Company and all Holders.

(c)    Award Agreement. Awards under the Plan shall be evidenced by Award Agreements that set forth the terms, conditions and limitations for each Award.

(d)    Indemnification. Neither the Board nor the Committee, nor any member of either or any delegate thereof, shall be liable for any act, omission, interpretation, construction or determination made in good faith in connection with the Plan, and the members of the Board and the Committee (and any delegate thereof) shall be entitled in all cases to indemnification and reimbursement by the Company in respect of any claim, loss, damage or expense (including, without limitation, reasonable attorneys’ fees) arising or resulting therefrom to the fullest extent permitted by law and/or under the Company’s governing documents, including its certificate of incorporation or bylaws, or any directors’ and officers’ liability insurance coverage which may be in effect from time to time and/or any indemnification agreement between such individual and the Company.

 

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(e)    Foreign Award Recipients. Notwithstanding any provision of the Plan to the contrary, in order to comply with the laws in other countries in which the Company and any Subsidiary operate or have employees or other individuals eligible for Awards, the Committee, in its sole discretion, shall have the power and authority to: (i) determine which Subsidiaries, if any, shall be covered by the Plan; (ii) determine which individuals, if any, outside the United States are eligible to participate in the Plan; (iii) modify the terms and conditions of any Award granted to individuals outside the United States to comply with applicable foreign laws; (iv) establish subplans and modify exercise procedures and other terms and procedures, to the extent the Committee determines such actions to be necessary or advisable (and such subplans and/or modifications shall be attached to the Plan as appendices); provided, however, that no such subplans and/or modifications shall increase the share limitation contained in Section 3(a) hereof; and (v) take any action, before or after an Award is made, that the Committee determines to be necessary or advisable to obtain approval or comply with any local governmental regulatory exemptions or approvals.

 

SECTION 3.

STOCK ISSUABLE UNDER THE PLAN; MERGERS AND OTHER TRANSACTIONS; SUBSTITUTION

(a)    Stock Issuable. The maximum number of Shares reserved and available for issuance under the Plan shall be 500,000 Shares, subject to adjustment as provided in Section 3(b). For purposes of this limitation, the Shares underlying any Awards that are forfeited, canceled, reacquired by the Company prior to vesting, satisfied without the issuance of Stock or otherwise terminated (other than by exercise) and Shares that are withheld upon exercise of an Option or settlement of an Award to cover the exercise price or tax withholding shall be added back to the Shares available for issuance under the Plan. Subject to such overall limitations, Shares may be issued up to such maximum number pursuant to any type or types of Award, and no more than 4,000,000 Shares may be issued pursuant to Incentive Stock Options. The Shares available for issuance under the Plan may be authorized but unissued Shares or Shares reacquired by the Company.

(b)    Changes in Stock. Subject to Section 3(c) hereof, if, as a result of any reorganization, recapitalization, reclassification, stock dividend, stock split, reverse stock split or other similar change in the Company’s capital stock, the outstanding Shares are increased or decreased or are exchanged for a different number or kind of shares or other securities of the Company, or additional Shares or new or different shares or other securities of the Company or other non-cash assets are distributed with respect to such Shares or other securities, in each case, without the receipt of consideration by the Company, or, if, as a result of any merger or consolidation, or sale of all or substantially all of the assets of the Company, the outstanding Shares are converted into or exchanged for other securities of the Company or any successor entity (or a parent or subsidiary thereof), the Committee shall make an appropriate and proportionate adjustment in (i) the maximum number of Shares reserved for issuance under the Plan, (ii) the number and kind of Shares or other securities subject to any then outstanding Awards under the Plan, (iii) the repurchase price, if any, per Share subject to each outstanding Award, and (iv) the exercise price for each Share subject to any then outstanding Stock Options

 

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under the Plan, without changing the aggregate exercise price (i.e., the exercise price multiplied by the number of Stock Options) as to which such Stock Options remain exercisable. The Committee shall in any event make such adjustments as may be required by Section 25102(o) of the California Corporation Code and the rules and regulations promulgated thereunder. The adjustment by the Committee shall be final, binding and conclusive. No fractional Shares shall be issued under the Plan resulting from any such adjustment, but the Committee in its discretion may make a cash payment in lieu of fractional shares.

(c)    Sale Events.

(i)    Options.

(A)    In the case of and subject to the consummation of a Sale Event, the Plan and all outstanding Options issued hereunder shall terminate upon the effective time of any such Sale Event unless assumed or continued by the successor entity, or new stock options or other awards of the successor entity or parent thereof are substituted therefor, with an equitable or proportionate adjustment as to the number and kind of shares and, if appropriate, the per share exercise prices, as such parties shall agree (after taking into account any acceleration hereunder and/or pursuant to the terms of any Award Agreement).

(B)    In the event of the termination of the Plan and all outstanding Options issued hereunder pursuant to Section 3(c), each Holder of Options shall be permitted, within a period of time prior to the consummation of the Sale Event as specified by the Committee, to exercise all such Options which are then exercisable or will become exercisable as of the effective time of the Sale Event; provided, however, that the exercise of Options not exercisable prior to the Sale Event shall be subject to the consummation of the Sale Event.

(C)    Notwithstanding anything to the contrary in Section 3(c)(i)(A), in the event of a Sale Event, the Company shall have the right, but not the obligation, to make or provide for a cash payment to the Holders of Options, without any consent of the Holders, in exchange for the cancellation thereof, in an amount equal to the difference between (A) the value as determined by the Committee of the consideration payable per share of Stock pursuant to the Sale Event (the “Sale Price”) times the number of Shares subject to outstanding Options being cancelled (to the extent then vested and exercisable, including by reason of acceleration in connection with such Sale Event, at prices not in excess of the Sale Price) and (B) the aggregate exercise price of all such outstanding vested and exercisable Options.

(ii)    Restricted Stock and Restricted Stock Unit Awards.

(A)    In the case of and subject to the consummation of a Sale Event, all unvested Restricted Stock and unvested Restricted Stock Unit Awards (other than those becoming vested as a result of the Sale Event) issued hereunder shall be forfeited immediately prior to the effective time of any such Sale Event unless assumed or continued by the successor entity, or awards of the successor entity or parent thereof are

 

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substituted therefor, with an equitable or proportionate adjustment as to the number and kind of shares subject to such awards as such parties shall agree (after taking into account any acceleration hereunder and/or pursuant to the terms of any Award Agreement).

(B)    In the event of the forfeiture of Restricted Stock pursuant to Section 3(c)(ii)(A), such Restricted Stock shall be repurchased from the Holder thereof at a price per share equal to the original per share purchase price paid by the Holder (subject to adjustment as provided in Section 3(b)) for such Shares.

(C)    Notwithstanding anything to the contrary in Section 3(c)(ii)(A), in the event of a Sale Event, the Company shall have the right, but not the obligation, to make or provide for a cash payment to the Holders of Restricted Stock or Restricted Stock Unit Awards, without consent of the Holders, in exchange for the cancellation thereof, in an amount equal to the Sale Price times the number of Shares subject to such Awards, to be paid at the time of such Sale Event or upon the later vesting of such Awards.

 

SECTION 4.

ELIGIBILITY

Grantees under the Plan will be such full or part-time officers and other employees, directors, Consultants and key persons of the Company and any Subsidiary who are selected from time to time by the Committee in its sole discretion; provided, however, that Awards shall be granted only to those individuals described in Rule 701(c) of the Securities Act.

 

SECTION 5.

STOCK OPTIONS

Upon the grant of a Stock Option, the Company and the grantee shall enter into an Award Agreement. The terms and conditions of each such Award Agreement shall be determined by the Committee, and such terms and conditions may differ among individual Awards and grantees.

Stock Options granted under the Plan may be either Incentive Stock Options or Non-Qualified Stock Options. Incentive Stock Options may be granted only to employees of the Company or any Subsidiary that is a “subsidiary corporation” within the meaning of Section 424(f) of the Code. To the extent that any Option does not qualify as an Incentive Stock Option, it shall be deemed a Non-Qualified Stock Option.

(a)    Terms of Stock Options. The Committee in its discretion may grant Stock Options to those individuals who meet the eligibility requirements of Section 4. Stock Options shall be subject to the following terms and conditions and shall contain such additional terms and conditions, not inconsistent with the terms of the Plan, as the Committee shall deem desirable.

(i)    Exercise Price. The exercise price per share for the Shares covered by a Stock Option shall be determined by the Committee at the time of grant but shall not be less than 100 percent of the Fair Market Value on the Grant Date. In the case of an Incentive Stock Option that is granted to a Ten Percent Owner, the exercise price per share for the Shares covered by such Incentive Stock Option shall not be less than 110 percent of the Fair Market Value on the Grant Date.

 

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(ii)    Option Term. The term of each Stock Option shall be fixed by the Committee, but no Stock Option shall be exercisable more than ten years from the Grant Date. In the case of an Incentive Stock Option that is granted to a Ten Percent Owner, the term of such Stock Option shall be no more than five years from the Grant Date.

(iii)    Exercisability; Rights of a Stockholder. Stock Options shall become exercisable and/or vested at such time or times, whether or not in installments, as shall be determined by the Committee at or after the Grant Date. The Award Agreement may permit a grantee to exercise all or a portion of a Stock Option immediately at grant; provided that the Shares issued upon such exercise shall be subject to restrictions and a vesting schedule identical to the vesting schedule of the related Stock Option, such Shares shall be deemed to be Restricted Stock for purposes of the Plan, and the optionee may be required to enter into an additional or new Award Agreement as a condition to exercise of such Stock Option. An optionee shall have the rights of a stockholder only as to Shares acquired upon the exercise of a Stock Option and not as to unexercised Stock Options. An optionee shall not be deemed to have acquired any Shares unless and until a Stock Option shall have been exercised pursuant to the terms of the Award Agreement and this Plan and the optionee’s name has been entered on the books of the Company as a stockholder.

(iv)    Method of Exercise. Stock Options may be exercised by an optionee in whole or in part, by the optionee giving written or electronic notice of exercise to the Company, specifying the number of Shares to be purchased. Payment of the purchase price may be made by one or more of the following methods (or any combination thereof) to the extent provided in the Award Agreement:

(A)    In cash, by certified or bank check, by wire transfer of immediately available funds, or other instrument acceptable to the Committee;

(B)    If permitted by the Committee, by the optionee delivering to the Company a promissory note, if the Board has expressly authorized the loan of funds to the optionee for the purpose of enabling or assisting the optionee to effect the exercise of his or her Stock Option; provided, that at least so much of the exercise price as represents the par value of the Stock shall be paid in cash if required by state law;

(C)    If permitted by the Committee and the Initial Public Offering has occurred (or the Stock otherwise becomes publicly-traded), through the delivery (or attestation to the ownership) of Shares that have been purchased by the optionee on the open market or that are beneficially owned by the optionee and are not then subject to restrictions under any Company plan. To the extent required to avoid variable accounting treatment under ASC 718 or other applicable accounting rules, such surrendered Shares if originally purchased from the Company shall have been owned by the optionee for at least six months. Such surrendered Shares shall be valued at Fair Market Value on the exercise date;

(D)    If permitted by the Committee and the Initial Public Offering has occurred (or the Stock otherwise becomes publicly-traded), by the optionee delivering to the Company a properly executed exercise notice together with irrevocable instructions to

 

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a broker to promptly deliver to the Company cash or a check payable and acceptable to the Company for the purchase price; provided that in the event the optionee chooses to pay the purchase price as so provided, the optionee and the broker shall comply with such procedures and enter into such agreements of indemnity and other agreements as the Committee shall prescribe as a condition of such payment procedure; or

(E)    If permitted by the Committee, and only with respect to Stock Options that are not Incentive Stock Options, by a “net exercise” arrangement pursuant to which the Company will reduce the number of Shares issuable upon exercise by the largest whole number of Shares with a Fair Market Value that does not exceed the aggregate exercise price.

Payment instruments will be received subject to collection. No certificates for Shares so purchased will be issued to the optionee or, with respect to uncertificated Stock, no transfer to the optionee on the records of the Company will take place, until the Company has completed all steps it has deemed necessary to satisfy legal requirements relating to the issuance and sale of the Shares, which steps may include, without limitation, (i) receipt of a representation from the optionee at the time of exercise of the Option that the optionee is purchasing the Shares for the optionee’s own account and not with a view to any sale or distribution of the Shares or other representations relating to compliance with applicable law governing the issuance of securities, (ii) the legending of the certificate (or notation on any book entry) representing the Shares to evidence the foregoing restrictions, and (iii) obtaining from optionee payment or provision for all withholding taxes due as a result of the exercise of the Option. The delivery of certificates representing the shares of Stock (or the transfer to the optionee on the records of the Company with respect to uncertificated Stock) to be purchased pursuant to the exercise of a Stock Option will be contingent upon (A) receipt from the optionee (or a purchaser acting in his or her stead in accordance with the provisions of the Stock Option) by the Company of the full purchase price for such Shares and the fulfillment of any other requirements contained in the Award Agreement or applicable provisions of laws and (B) if required by the Company, the optionee shall have entered into any stockholders agreements or other agreements with the Company and/or certain other of the Company’s stockholders relating to the Stock. In the event an optionee chooses to pay the purchase price by previously-owned Shares through the attestation method, the number of Shares transferred to the optionee upon the exercise of the Stock Option shall be net of the number of Shares attested to.

(b)    Annual Limit on Incentive Stock Options. To the extent required for “incentive stock option” treatment under Section 422 of the Code, the aggregate Fair Market Value (determined as of the Grant Date) of the Shares with respect to which Incentive Stock Options granted under the Plan and any other plan of the Company or its parent and any Subsidiary that become exercisable for the first time by an optionee during any calendar year shall not exceed $100,000 or such other limit as may be in effect from time to time under Section 422 of the Code. To the extent that any Stock Option exceeds this limit, it shall constitute a Non-Qualified Stock Option.

(c)    Termination. Any portion of a Stock Option that is not vested and exercisable on the date of termination of an optionee’s Service Relationship shall immediately expire and be null and void. Once any portion of the Stock Option becomes vested and exercisable, the

 

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optionee’s right to exercise such portion of the Stock Option (or the optionee’s representatives and legatees as applicable) in the event of a termination of the optionee’s Service Relationship shall continue until the earliest of: (i) the date which is: (A) 12 months following the date on which the optionee’s Service Relationship terminates due to death or Disability (or such longer period of time as determined by the Committee and set forth in the applicable Award Agreement), or (B) three months following the date on which the optionee’s Service Relationship terminates if the termination is due to any reason other than death or Disability (or such longer period of time as determined by the Committee and set forth in the applicable Award Agreement), or (ii) the Expiration Date set forth in the Award Agreement; provided that notwithstanding the foregoing, an Award Agreement may provide that if the optionee’s Service Relationship is terminated for Cause, the Stock Option shall terminate immediately and be null and void upon the date of the optionee’s termination and shall not thereafter be exercisable.

 

SECTION 6.

RESTRICTED STOCK AWARDS

(a)    Nature of Restricted Stock Awards. The Committee may, in its sole discretion, grant (or sell at par value or such other purchase price determined by the Committee) to an eligible individual under Section 4 hereof a Restricted Stock Award under the Plan. The Committee shall determine the restrictions and conditions applicable to each Restricted Stock Award at the time of grant. Conditions may be based on continuing employment (or other Service Relationship), achievement of pre-established performance goals and objectives and/or such other criteria as the Committee may determine. Upon the grant of a Restricted Stock Award, the Company and the grantee shall enter into an Award Agreement. The terms and conditions of each such Award Agreement shall be determined by the Committee, and such terms and conditions may differ among individual Awards and grantees.

(b)    Rights as a Stockholder. Upon the grant of the Restricted Stock Award and payment of any applicable purchase price, a grantee of Restricted Stock shall be considered the record owner of and shall be entitled to vote the Restricted Stock if, and to the extent, such Shares are entitled to voting rights, subject to such conditions contained in the Award Agreement. The grantee shall be entitled to receive all dividends and any other distributions declared on the Shares; provided, however, that the Company is under no duty to declare any such dividends or to make any such distribution. Unless the Committee shall otherwise determine, certificates evidencing the Restricted Stock shall remain in the possession of the Company until such Restricted Stock is vested as provided in subsection (d) below of this Section, and the grantee shall be required, as a condition of the grant, to deliver to the Company a stock power endorsed in blank and such other instruments of transfer as the Committee may prescribe.

(c)    Restrictions. Restricted Stock may not be sold, assigned, transferred, pledged or otherwise encumbered or disposed of except as specifically provided herein or in the Award Agreement. Except as may otherwise be provided by the Committee either in the Award Agreement or, subject to Section 12 below, in writing after the Award Agreement is issued, if a grantee’s Service Relationship with the Company and any Subsidiary terminates, the Company or its assigns shall have the right, as may be specified in the relevant instrument, to repurchase some or all of the Shares subject to the Award at such purchase price as is set forth in the Award Agreement.

 

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(d)    Vesting of Restricted Stock. The Committee at the time of grant shall specify in the Award Agreement the date or dates and/or the attainment of preestablished performance goals, objectives and other conditions on which the substantial risk of forfeiture imposed shall lapse and the Restricted Stock shall become vested, subject to such further rights of the Company or its assigns as may be specified in the Award Agreement.

 

SECTION 7.

UNRESTRICTED STOCK AWARDS

The Committee may, in its sole discretion, grant (or sell at par value or such other purchase price determined by the Committee) to an eligible person under Section 4 hereof an Unrestricted Stock Award under the Plan. Unrestricted Stock Awards may be granted in respect of past services or other valid consideration, or in lieu of cash compensation due to such grantee.

 

SECTION 8.

RESTRICTED STOCK UNITS

(a)    Nature of Restricted Stock Units. The Committee may, in its sole discretion, grant to an eligible person under Section 4 hereof Restricted Stock Units under the Plan. The Committee shall determine the restrictions and conditions applicable to each Restricted Stock Unit at the time of grant. Vesting conditions may be based on continuing employment (or other Service Relationship), achievement of pre-established performance goals and objectives and/or other such criteria as the Committee may determine. Upon the grant of Restricted Stock Units, the grantee and the Company shall enter into an Award Agreement. The terms and conditions of each such Award Agreement shall be determined by the Committee and may differ among individual Awards and grantees. On or promptly following the vesting date or dates applicable to any Restricted Stock Unit, but in no event later than March 15 of the year following the year in which such vesting occurs, such Restricted Stock Unit(s) shall be settled in the form of cash or shares of Stock, as specified in the Award Agreement. Restricted Stock Units may not be sold, assigned, transferred, pledged, or otherwise encumbered or disposed of.

(b)    Rights as a Stockholder. A grantee shall have the rights of a stockholder only as to Shares, if any, acquired upon settlement of Restricted Stock Units. A grantee shall not be deemed to have acquired any such Shares unless and until the Restricted Stock Units shall have been settled in Shares pursuant to the terms of the Plan and the Award Agreement, the Company shall have issued and delivered a certificate representing the Shares to the grantee (or transferred on the records of the Company with respect to uncertificated stock), and the grantee’s name has been entered in the books of the Company as a stockholder.

(c)    Termination. Except as may otherwise be provided by the Committee either in the Award Agreement or in writing after the Award Agreement is issued, a grantee’s right in all Restricted Stock Units that have not vested shall automatically terminate upon the grantee’s cessation of Service Relationship with the Company and any Subsidiary for any reason.

 

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SECTION 9.

TRANSFER RESTRICTIONS; COMPANY RIGHT OF FIRST REFUSAL; COMPANY REPURCHASE RIGHTS

(a)    Restrictions on Transfer.

(i)    Non-Transferability of Stock Options. Stock Options and, prior to exercise, the Shares issuable upon exercise of such Stock Option, shall not be transferable by the optionee otherwise than by will, or by the laws of descent and distribution, and all Stock Options shall be exercisable, during the optionee’s lifetime, only by the optionee, or by the optionee’s legal representative or guardian in the event of the optionee’s incapacity. Notwithstanding the foregoing, the Committee, in its sole discretion, may provide in the Award Agreement regarding a given Stock Option that the optionee may transfer by gift, without consideration for the transfer, his or her NonQualified Stock Options to his or her family members (as defined in Rule 701 of the Securities Act), to trusts for the benefit of such family members, or to partnerships in which such family members are the only partners (to the extent such trusts or partnerships are considered “family members” for purposes of Rule 701 of the Securities Act), provided that the transferee agrees in writing with the Company to be bound by all of the terms and conditions of this Plan and the applicable Award Agreement, including the execution of a stock power upon the issuance of Shares. Stock Options, and the Shares issuable upon exercise of such Stock Options, shall be restricted as to any pledge, hypothecation, or other transfer, including any short position, any “put equivalent position” (as defined in the Exchange Act) or any “call equivalent position” (as defined in the Exchange Act) prior to exercise.

(ii)    Shares. No Shares shall be sold, assigned, transferred, pledged, hypothecated, given away or in any other manner disposed of or encumbered, whether voluntarily or by operation of law, unless (i) the transfer is in compliance with the terms of the applicable Award Agreement, all applicable securities laws (including, without limitation, the Securities Act), and with the terms and conditions of this Section 9, (ii) the transfer does not cause the Company to become subject to the reporting requirements of the Exchange Act, and (iii) the transferee consents in writing to be bound by the provisions of the Plan and the Award Agreement, including this Section 9. In connection with any proposed transfer, the Committee may require the transferor to provide at the transferor’s own expense an opinion of counsel to the transferor, satisfactory to the Committee, that such transfer is in compliance with all foreign, federal and state securities laws (including, without limitation, the Securities Act). Any attempted transfer of Shares not in accordance with the terms and conditions of this Section 9 shall be null and void, and the Company shall not reflect on its records any change in record ownership of any Shares as a result of any such transfer, shall otherwise refuse to recognize any such transfer and shall not in any way give effect to any such transfer of Shares. The Company shall be entitled to seek protective orders, injunctive relief and other remedies available at law or in equity including, without limitation, seeking specific performance or the rescission of any transfer not made in strict compliance with the provisions of this Section 9. Subject to the foregoing general provisions, and unless otherwise provided in the applicable Award Agreement, Shares may be transferred pursuant to the following specific terms and conditions (provided that with respect to any transfer of Restricted Stock, all vesting and forfeiture provisions shall continue to apply with respect to the original recipient):

 

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(A)    Transfers to Permitted Transferees. The Holder may transfer any or all of the Shares to one or more Permitted Transferees; provided, however, that following such transfer, such Shares shall continue to be subject to the terms of this Plan (including this Section 9) and such Permitted Transferee(s) shall, as a condition to any such transfer, deliver a written acknowledgment to that effect to the Company and shall deliver a stock power to the Company with respect to the Shares. Notwithstanding the foregoing, the Holder may not transfer any of the Shares to a Person whom the Company reasonably determines is a direct competitor or a potential competitor of the Company or any of its Subsidiaries.

(B)    Transfers Upon Death. Upon the death of the Holder, any Shares then held by the Holder at the time of such death and any Shares acquired after the Holder’s death by the Holder’s legal representative shall be subject to the provisions of this Plan, and the Holder’s estate, executors, administrators, personal representatives, heirs, legatees and distributees shall be obligated to convey such Shares to the Company or its assigns under the terms contemplated by the Plan and the Award Agreement.

(b)    Right of First Refusal. In the event that a Holder desires at any time to sell or otherwise transfer all or any part of his or her Shares (other than shares of Restricted Stock which by their terms are not transferrable), the Holder first shall give written notice to the Company of the Holder’s intention to make such transfer. Such notice shall state the number of Shares that the Holder proposes to sell (the “Offered Shares”), the price and the terms at which the proposed sale is to be made and the name and address of the proposed transferee. At any time within 30 days after the receipt of such notice by the Company, the Company or its assigns may elect to purchase all or any portion of the Offered Shares at the price and on the terms offered by the proposed transferee and specified in the notice. The Company or its assigns shall exercise this right by mailing or delivering written notice to the Holder within the foregoing 30-day period. If the Company or its assigns elect to exercise its purchase rights under this Section 9(b), the closing for such purchase shall, in any event, take place within 45 days after the receipt by the Company of the initial notice from the Holder. In the event that the Company or its assigns do not elect to exercise such purchase right, or in the event that the Company or its assigns do not pay the full purchase price within such 45-day period, the Holder shall be required to pay a transaction processing fee of $10,000 to the Company (unless waived by the Committee) and then may, within 60 days thereafter, sell the Offered Shares to the proposed transferee and at the same price and on the same terms as specified in the Holder’s notice. Any Shares not sold to the proposed transferee shall remain subject to the Plan. If the Holder is a party to any stockholders agreements or other agreements with the Company and/or certain other of the Company’s stockholders relating to the Shares, (i) the transferring Holder shall comply with the requirements of such stockholders agreements or other agreements relating to any proposed transfer of the Offered Shares, and (ii) any proposed transferee that purchases Offered Shares shall enter into such stockholders agreements or other agreements with the Company and/or certain of the Company’s stockholders relating to the Offered Shares on the same terms and in the same capacity as the transferring Holder.

 

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(c)    Company’s Right of Repurchase.

(i)    Right of Repurchase for Unvested Shares Issued Upon the Exercise of an Option. Upon a Termination Event, the Company or its assigns shall have the right and option to repurchase from a Holder of Shares acquired upon exercise of a Stock Option which are still subject to a risk of forfeiture as of the Termination Event. Such repurchase rights may be exercised by the Company within the later of (A) six months following the date of such Termination Event or (B) seven months after the acquisition of Shares upon exercise of a Stock Option. The repurchase price shall be equal to the lower of the original per share price paid by the Holder, subject to adjustment as provided in Section 3(b) of the Plan, or the current Fair Market Value of such Shares as of the date the Company elects to exercise its repurchase rights.

(ii)    Right of Repurchase With Respect to Restricted Stock. Upon a Termination Event, the Company or its assigns shall have the right and option to repurchase from a Holder of Shares received pursuant to a Restricted Stock Award any Shares that are still subject to a risk of forfeiture as of the Termination Event. Such repurchase right may be exercised by the Company within six months following the date of such Termination Event. The repurchase price shall be the lower of the original per share purchase price paid by the Holder, subject to adjustment as provided in Section 3(b) of the Plan, or the current Fair Market Value of such Shares as of the date the Company elects to exercise its repurchase rights.

(iii)    Procedure. Any repurchase right of the Company shall be exercised by the Company or its assigns by giving the Holder written notice on or before the last day of the repurchase period of its intention to exercise such repurchase right. Upon such notification, the Holder shall promptly surrender to the Company, free and clear of any liens or encumbrances, any certificates representing the Shares being purchased, together with a duly executed stock power for the transfer of such Shares to the Company or the Company’s assignee or assignees. Upon the Company’s or its assignee’s receipt of the certificates from the Holder, the Company or its assignee or assignees shall deliver to him, her or them a check for the applicable repurchase price; provided, however, that the Company may pay the repurchase price by offsetting and canceling any indebtedness then owed by the Holder to the Company.

(d)    Reserved.

(e)    Escrow Arrangement.

(i)    Escrow. In order to carry out the provisions of this Section 9 of this Plan more effectively, the Company shall hold any Shares issued pursuant to Awards granted under the Plan in escrow together with separate stock powers executed by the Holder in blank for transfer. The Company shall not dispose of the Shares except as otherwise provided in this Plan. In the event of any repurchase by the Company (or any of its assigns), the Company is hereby authorized by the Holder, as the Holder’s attorney-in-fact, to date and complete the stock powers necessary for the transfer of the Shares being purchased and to transfer such Shares in accordance with the terms hereof. At such time as any Shares are no longer subject to the Company’s repurchase and first refusal rights, the Company shall, at the written request of the Holder, deliver to the Holder a certificate representing such Shares with the balance of the Shares to be held in escrow pursuant to this Section.

 

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(ii)    Remedy. Without limitation of any other provision of this Plan or other rights, in the event that a Holder or any other Person is required to sell a Holder’s Shares pursuant to the provisions of Sections 9(b) or (c) hereof and in the further event that he or she refuses or for any reason fails to deliver to the Company or its designated purchaser of such Shares the certificate or certificates evidencing such Shares together with a related stock power, the Company or such designated purchaser may deposit the applicable purchase price for such Shares with a bank designated by the Company, or with the Company’s independent public accounting firm, as agent or trustee, or in escrow, for such Holder or other Person, to be held by such bank or accounting firm for the benefit of and for delivery to him, her, them or it, and/or, in its discretion, pay such purchase price by offsetting any indebtedness then owed by such Holder as provided above. Upon any such deposit and/or offset by the Company or its designated purchaser of such amount and upon notice to the Person who was required to sell the Shares to be sold pursuant to the provisions of Sections 9(b) or (c), such Shares shall at such time be deemed to have been sold, assigned, transferred and conveyed to such purchaser, such Holder shall have no further rights thereto (other than the right to withdraw the payment thereof held in escrow, if applicable), and the Company shall record such transfer in its stock transfer book or in any appropriate manner.

(f)    Lockup Provision. If requested by the Company, a Holder shall not sell or otherwise transfer or dispose of any Shares (including, without limitation, pursuant to Rule 144 under the Securities Act) held by him or her for such period following the effective date of a public offering by the Company of Shares as the Company shall specify reasonably and in good faith. If requested by the underwriter engaged by the Company, each Holder shall execute a separate letter confirming his or her agreement to comply with this Section.

(g)    Adjustments for Changes in Capital Structure. If, as a result of any reorganization, recapitalization, reclassification, stock dividend, stock split, reverse stock split or other similar change in the Common Stock, the outstanding Shares are increased or decreased or are exchanged for a different number or kind of securities of the Company, the restrictions contained in this Section 9 shall apply with equal force to additional and/or substitute securities, if any, received by Holder in exchange for, or by virtue of his or her ownership of, Shares.

(h)    Termination. The terms and provisions of Section 9(b) and Section 9(c) (except for the Company’s right to repurchase Shares still subject to a risk of forfeiture upon a Termination Event) shall terminate upon the closing of the Company’s Initial Public Offering or upon consummation of any Sale Event, in either case as a result of which Shares are registered under Section 12 of the Exchange Act and publicly-traded on any national security exchange.

 

SECTION 10.

TAX WITHHOLDING

(a)    Payment by Grantee. Each grantee shall, no later than the date as of which the value of an Award or of any Shares or other amounts received thereunder first becomes includable in the gross income of the grantee for income tax purposes, pay to the Company, or make arrangements satisfactory to the Committee regarding payment of, any Federal, state, or local taxes of any kind required by law to be withheld by the Company with respect to such income. The Company and any Subsidiary shall, to the extent permitted by law, have the right to deduct any such taxes from any payment of any kind otherwise due to the grantee. The

 

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Company’s obligation to deliver stock certificates (or evidence of book entry) to any grantee is subject to and conditioned on any such tax withholding obligations being satisfied by the grantee.

(b)    Payment in Stock. The Company’s minimum required tax withholding obligation may be satisfied, in whole or in part, by the Company withholding from Shares to be issued pursuant to an Award a number of Shares having an aggregate Fair Market Value (as of the date the withholding is effected) that would satisfy the minimum withholding amount due.

 

SECTION 11.

SECTION 409A AWARDS.

To the extent that any Award is determined to constitute “nonqualified deferred compensation” within the meaning of Section 409A (a “409A Award”), the Award shall be subject to such additional rules and requirements as may be specified by the Committee from time to time. In this regard, if any amount under a 409A Award is payable upon a “separation from service” (within the meaning of Section 409A) to a grantee who is considered a “specified employee” (within the meaning of Section 409A), then no such payment shall be made prior to the date that is the earlier of (i) six months and one day after the grantee’s separation from service, or (ii) the grantee’s death, but only to the extent such delay is necessary to prevent such payment from being subject to interest, penalties and/or additional tax imposed pursuant to Section 409A. The Company makes no representation or warranty and shall have no liability to any grantee under the Plan or any other Person with respect to any penalties or taxes under Section 409A that are, or may be, imposed with respect to any Award.

 

SECTION 12.

AMENDMENTS AND TERMINATION

The Board may, at any time, amend or discontinue the Plan and the Committee may, at any time, amend or cancel any outstanding Award for the purpose of satisfying changes in law or for any other lawful purpose, but no such action shall adversely affect rights under any outstanding Award without the consent of the holder of the Award. The Committee may exercise its discretion to reduce the exercise price of outstanding Stock Options or effect repricing through cancellation of outstanding Stock Options and by granting such holders new Awards in replacement of the cancelled Stock Options. To the extent determined by the Committee to be required either by the Code to ensure that Incentive Stock Options granted under the Plan are qualified under Section 422 of the Code or otherwise, Plan amendments shall be subject to approval by the Company stockholders entitled to vote at a meeting of stockholders. Nothing in this Section 12 shall limit the Board’s or Committee’s authority to take any action permitted pursuant to Section 3(c). The Board reserves the right to amend the Plan and/or the terms of any outstanding Stock Options to the extent reasonably necessary to comply with the requirements of the exemption pursuant to paragraph (f)(4) of Rule 12h-1 of the Exchange Act.

 

SECTION 13.

STATUS OF PLAN

With respect to the portion of any Award that has not been exercised and any payments in cash, Stock or other consideration not received by a grantee, a grantee shall have no rights greater than those of a general creditor of the Company unless the Committee shall otherwise expressly so determine in connection with any Award.

 

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SECTION 14.

GENERAL PROVISIONS

(a)    No Distribution; Compliance with Legal Requirements. The Committee may require each person acquiring Shares pursuant to an Award to represent to and agree with the Company in writing that such person is acquiring the Shares without a view to distribution thereof. No Shares shall be issued pursuant to an Award until all applicable securities law and other legal and stock exchange or similar requirements have been satisfied. The Committee may require the placing of such stop-orders and restrictive legends on certificates for Stock and Awards as it deems appropriate.

(b)    Delivery of Stock Certificates. Stock certificates to grantees under the Plan shall be deemed delivered for all purposes when the Company or a stock transfer agent of the Company shall have mailed such certificates in the United States mail, addressed to the grantee, at the grantee’s last known address on file with the Company; provided that stock certificates to be held in escrow pursuant to Section 9 of the Plan shall be deemed delivered when the Company shall have recorded the issuance in its records. Uncertificated Stock shall be deemed delivered for all purposes when the Company or a stock transfer agent of the Company shall have given to the grantee by electronic mail (with proof of receipt) or by United States mail, addressed to the grantee, at the grantee’s last known address on file with the Company, notice of issuance and recorded the issuance in its records (which may include electronic “book entry” records).

(c)    No Employment Rights. The adoption of the Plan and the grant of Awards do not confer upon any Person any right to continued employment or Service Relationship with the Company or any Subsidiary.

(d)    Trading Policy Restrictions. Option exercises and other Awards under the Plan shall be subject to the Company’s insider trading policy-related restrictions, terms and conditions as may be established by the Committee, or in accordance with policies set by the Committee, from time to time.

(e)    Designation of Beneficiary. Each grantee to whom an Award has been made under the Plan may designate a beneficiary or beneficiaries to exercise any Award on or after the grantee’s death or receive any payment under any Award payable on or after the grantee’s death. Any such designation shall be on a form provided for that purpose by the Committee and shall not be effective until received by the Committee. If no beneficiary has been designated by a deceased grantee, or if the designated beneficiaries have predeceased the grantee, the beneficiary shall be the grantee’s estate.

(f)    Legend. Any certificate(s) representing the Shares shall carry substantially the following legend (and with respect to uncertificated Stock, the book entries evidencing such shares shall contain the following notation):

The transferability of this certificate and the shares of stock represented hereby are subject to the restrictions, terms and conditions (including repurchase and restrictions against transfers) contained in the AdMIRx Inc. 2017 Stock Option and Grant Plan

 

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and any agreements entered into thereunder by and between the company and the holder of this certificate (a copy of which is available at the offices of the company for examination).

(g)    Information to Holders of Options. In the event the Company is relying on the exemption from the registration requirements of Section 12(g) of the Exchange Act contained in paragraph (f)(1) of Rule 12h-1 of the Exchange Act, the Company shall provide the information described in Rule 701(e)(3), (4) and (5) of the Securities Act to all holders of Options in accordance with the requirements thereunder. The foregoing notwithstanding, the Company shall not be required to provide such information unless the optionholder has agreed in writing, on a form prescribed by the Company, to keep such information confidential.

 

SECTION 15.

EFFECTIVE DATE OF PLAN

The Plan shall become effective upon adoption by the Board and shall be approved by stockholders in accordance with applicable state law and the Company’s articles of incorporation and bylaws within 12 months thereafter. If the stockholders fail to approve the Plan within 12 months after its adoption by the Board of Directors, then any Awards granted or sold under the Plan shall be rescinded and no additional grants or sales shall thereafter be made under the Plan. Subject to such approval by stockholders and to the requirement that no Shares may be issued hereunder prior to such approval, Stock Options and other Awards may be granted hereunder on and after adoption of the Plan by the Board. No grants of Stock Options and other Awards may be made hereunder after the tenth anniversary of the date the Plan is adopted by the Board or the date the Plan is approved by the Company’s stockholders, whichever is earlier.

 

SECTION 16.

GOVERNING LAW

This Plan, all Awards and any controversy arising out of or relating to this Plan and all Awards shall be governed by and construed in accordance with the General Corporation Law of the State of Delaware as to matters within the scope thereof, and as to all other matters shall be governed by and construed in accordance with the internal laws of state of principal place of business, without regard to conflict of law principles that would result in the application of any law other than the law of the State of Delaware.

DATE ADOPTED BY THE BOARD OF DIRECTORS:    December 7, 2017

DATE APPROVED BY THE STOCKHOLDERS:             December 7, 2017

 

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Exhibit 23.1

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

We consent to the use in this Registration Statement on Form S-4 of our report dated March 9, 2023, relating to the consolidated financial statements of Homology Medicines, Inc. We also consent to the reference to us under the heading “Experts” in such Registration Statement.

/s/ Deloitte & Touche LLP

Boston, Massachusetts

December 15, 2023

Exhibit 23.2

Consent of Independent Registered Public Accounting Firm

We consent to the reference to our firm under the caption “Experts” and to the use of our report dated December 15, 2023, with respect to the consolidated financial statements of Q32 Bio, Inc. included in the Proxy Statement of Homology Medicines, Inc. that is made a part of the Registration Statement (Form S-4) and related Proxy Statement/Prospectus of Homology Medicines, Inc. for the registration of its common stock.

/s/ Ernst & Young LLP

Boston, Massachusetts

December 15, 2023

Exhibit 99.1

 

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SCAN TO VIEW MATERIALS & VOTE w HOMOLOGY MEDICINES, INC. VOTE BY INTERNET ONE PATRIOTS PARK Before The Meeting - Go to www.proxyvote.com or scan the QR Barcode above BEDFORD, MA 01730 Use the Internet to transmit your voting instructions and for electronic delivery of information up until 11:59 P.M. Eastern Time on [TBD], 2024. Have your proxy card in hand when you access the web site and follow the instructions to obtain your records and to create an electronic voting instruction form. During The Meeting - Go to www.virtualshareholdermeeting.com/FIXX2024SM You may attend the Special Meeting via the Internet and vote during the Special Meeting. Have the information that is printed in the box marked by the arrow available and follow the instructions. VOTE BY PHONE - 1-800-690-6903 Use any touch-tone telephone to transmit your voting instructions up until 11:59 P.M. Eastern Time on [TBD], 2024. Have your proxy card in hand when you call and then follow the instructions. VOTE BY MAIL Mark, sign and date your proxy card and return it in the postage-paid envelope we have provided or return it to Vote Processing, c/o Broadridge, 51 Mercedes Way, Edgewood, NY 11717. TO VOTE, MARK BLOCKS BELOW IN BLUE OR BLACK INK AS FOLLOWS: V26825-S77999 KEEP THIS PORTION FOR YOUR RECORDS THIS PROXY CARD IS VALID ONLY WHEN SIGNED AND DATED. DETACH AND RETURN THIS PORTION ONLY HOMOLOGY MEDICINES, INC. The Board of Directors recommends you vote FOR the following proposals: 1. To approve the issuance of shares of common stock of Homology to stockholders of Q32 Bio Inc., or Q32, pursuant to the terms of the Agreement and For Against Abstain Plan of Merger, dated as of November 16, 2023, by and among Homology, Q32, and Kenobi Merger Sub, Inc., a direct, wholly owned subsidiary of Homology, or Merger Sub, pursuant to which Merger Sub will merge with and into Q32, with Q32 surviving as a wholly owned subsidiary of Homology, and the surviving corporation of the merger, or the Merger, and the change of control resulting from the Merger, or the Stock Issuance Proposal; ! ! ! 2. To approve an amendment to the Restated Certificate of Incorporation of Homology to increase the number of authorized shares of Homology common ! ! ! stock to 400,000,000, subject to the Homology board of directors’ authority to abandon such amendment, or the Authorized Share Increase Proposal; 3. To approve an amendment to the Restated Certificate of Incorporation of Homology to effect a reverse stock split of Homology’s issued and outstanding common stock at a ratio ranging from any whole number between 1-for- and 1-for- , as determined by the Homology board of directors in its ! ! ! discretion subject to the Homology board of directors’ authority to abandon such amendment, or the Reverse Stock Split Proposal; 4. To approve the 2024 Stock Option and Incentive Plan; ! ! ! 5. To approve the 2024 Employee Stock Purchase Plan; and ! ! ! 6. To consider and vote upon an adjournment of the Homology Special Meeting of Stockholders, if necessary, to solicit additional proxies if there are not ! ! ! sufficient votes in favor of the Stock Issuance Proposal, the Authorized Share Increase Proposal and the Reverse Stock Split Proposal, or the Adjournment Proposal. Please sign exactly as your name(s) appear(s) hereon. When signing as attorney, executor, administrator, or other fiduciary, please give full title as such. Joint owners should each sign personally. All holders must sign. If a corporation or partnership, please sign in full corporate or partnership name by authorized officer. Signature [PLEASE SIGN WITHIN BOX] Date Signature (Joint Owners) Date


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Important Notice Regarding the Availability of Proxy Materials for the Special Meeting: The Notice and Proxy Statement is available at www.proxyvote.com. V26826-S77999 HOMOLOGY MEDICINES, INC. Special Meeting of Stockholders [TBD], 2024 [TBD] Eastern Time This proxy is solicited by the Board of Directors The undersigned stockholder(s) hereby appoint(s) Paul Alloway, Ph.D. and Charles Michaud, Jr., or either of them, as proxies, each with the power to appoint his substitute, and hereby authorize(s) them to represent and to vote, as designated on the reverse side of this proxy card, all of the shares of common stock of HOMOLOGY MEDICINES, INC. that the undersigned stockholder(s) is/are entitled to vote at the Special Meeting of Stockholders to be held via the internet at www.virtualshareholdermeeting.com/FIXX2024SM on [TBD], 2024, at [TBD] Eastern Time, or any continuation, adjournment or postponement thereof. This proxy, when properly executed, will be voted in the manner directed herein. If no such direction is made, this proxy will be voted in accordance with the Board of Directors’ recommendations. Continued and to be signed on reverse side

Exhibit 99.3

Consent of Cowen and Company, LLC

The Board of Directors

Homology Medicines, Inc.

One Patriots Park

Bedford, Massachusetts 01730

The Board of Directors:

We hereby consent to the inclusion of our opinion letter, dated November 15, 2023, to the Board of Directors of Homology Medicines, Inc. (“Homology”), as Annex H to, and reference to such opinion letter under the headings “PROSPECTUS SUMMARY — Opinion of Homology’s Financial Advisor” and “THE MERGER — Opinion of Homology’s Financial Advisor” in, the proxy statement/prospectus relating to the proposed transaction involving Homology and Q32 Bio Inc., which proxy statement/prospectus forms a part of the Registration Statement on Form S-4 of Homology (the “Registration Statement”). By giving such consent, we do not thereby admit that we are experts with respect to any part of such Registration Statement within the meaning of the term “expert” as used in, or that we come within the category of persons whose consent is required under, the Securities Act of 1933, as amended, or the rules and regulations of the Securities and Exchange Commission promulgated thereunder.

 

Very truly yours,

/s/ Cowen and Company, LLC

Cowen and Company, LLC

December 15, 2023

Exhibit 99.4

Consent to be Named as a Director

In connection with the filing by Homology Medicines, Inc. (the “Company”) of the Registration Statement on Form S-4 with the Securities and Exchange Commission under the Securities Act of 1933, as amended (the “Securities Act”), I hereby consent, pursuant to Rule 438 of the Securities Act, to being named in the Registration Statement and any and all amendments and supplements thereto as a person who has agreed to serve as a director of the Company following its merger with Q32 Bio Inc. (which shall be known as Q32 Bio Inc.) as described in the Registration Statement. I also consent to the filing of this consent as an exhibit to such Registration Statement and any amendments thereto.

Dated: December 15, 2023

 

By:  

/s/ Jodie Morrison

Name:   Jodie Morrison