8-K
Orchestra BioMed Holdings, Inc. (OBIO)
UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549
FORM 8-K
CURRENT REPORT PURSUANT TO SECTION 13OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): July 31, 2025
ORCHESTRA BIOMED
HOLDINGS, INC. (Exact name of registrant as specified in its charter)
| Delaware(State or other jurisdictionof incorporation) | 001-39421(CommissionFile Number) | 92-2038755(IRS EmployerIdentification No.) |
|---|---|---|
| 150 Union Square DriveNew Hope, Pennsylvania 18938(Address of principal executive offices, including zip code)Registrant’s telephone number, including area code: (215) 862-5797(Former name or former address, if changed since last report) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities<br>Act (17 CFR 230.425) |
|---|---|
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange<br>Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under<br>the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under<br>the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common stock, par value $0.0001 per share | OBIO | The Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
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 13(a) of the Exchange Act. ¨
Item 1.01. Entry into Material Definitive Agreement.
Ligand Pharmaceuticals Incorporated RevenueParticipation Right Purchase and Sale Agreement and Purchase of Shares
On July 31, 2025, Orchestra BioMed Holdings, Inc. (the “Company”) entered into a revenue participation right purchase and sale agreement (the “RevenuePurchase and Sale Agreement”) with Ligand Pharmaceuticals Incorporated (the “Purchaser”). Under the terms of the Revenue Purchase and Sale Agreement, in exchange for payment of $35.0 million (the “Investment Amount”), less certain reimbursable expenses, the Purchaser acquired from the Company the right to receive tiered revenue payments (the “RevenueInterest”) with respect to revenue (including certain licensing revenue) received by the Company in a calendar year in connection with worldwide net product sales, or other product revenue received by, by the Company and its licensees (“Annual Net Sales”) of (a) the Company’s BACKBEAT Cardiac Neuromodulation Therapy^TM^, also known as atrioventricular interval modulation (“AVIM”) therapy (the “Primary Product”) in the field of hypertension treatment and (b) the Company’s Virtue® Sirolimus AngioInfusion Balloon (“Virtue SAB”) (the “Secondary Product” and together with the Primary Product, the “Products”) in the field of coronary artery treatment.
Subject to the Performance Ratchet (as defined below), the table below summarizes the Revenue Interest rates based on the percentage of Annual Net Sales of the Products:
| Annual Net Sales | Applicable Purchaser Revenue Interest Rate |
|---|---|
| Less than or equal to $100 million, in any field | 17.0% |
| Greater than $100 million, only in the fields described above | 4.0% |
Pursuant to the Revenue Purchase and Sale Agreement, the Investment Amount shall be paid in two tranches: (i) $20.0 million payable at the closing of the transaction (the “Closing”) and (ii) $15.0 million payable two hundred and seventy days following the Closing (the “Second Installment”), provided certain conditions have been met. In accordance with the terms of the Revenue Purchase and Sale Agreement, the Applicable Purchaser Revenue Interest Rates set forth in the table above will incrementally increase from 17.0% and 4.0% up to 20.0% and 7.0%, respectively, if the Company does not achieve certain enrollment milestones relating to the BACKBEAT clinical study through January 1, 2027 (the “PerformanceRatchet”).
The Revenue Interest in respect of Annual Net Sales of the Products will end on the date in which no Product is being developed or commercialized by or on behalf of the Company, any of its affiliates, or any of its or their licensees or distributors and Purchaser has received the last Revenue Interest payment payable under the terms of the Revenue Purchase and Sale Agreement. The obligations arising under the Revenue Purchase and Sale Agreement are secured by security interests in, and pledges over, the Revenue Interest, the Revenue Participation Right (as defined in the Revenue Purchase and Sale Agreement) and the Company’s interests in the Products and associated intellectual property rights, subject to certain agreed security principles, permitted liens and other customary exceptions and qualifications, and the security interests in the Products and associated intellectual property rights of the Company are subordinate in right of payment to the prior payment in full of the outstanding indebtedness under the Hercules Loan Agreement (as defined in the Revenue Purchase and Sale Agreement). The Revenue Purchase and Sale Agreement contains customary representations, warranties and indemnities of the Company and Purchaser, and customary covenants on the part of the Company. Closing of the transaction is subject to certain conditions including, among others, the closing of the Ligand Stock Purchase Agreement (as defined below), which is contingent upon the closing of the Subsequent Offering (as defined below).
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In connection with the sale of the Revenue Interest, and pursuant to the terms of the Revenue Purchase and Sale Agreement, the Company has agreed to issue to the Purchaser, at the Closing, a warrant (the “Warrant”) to purchase up to 2,000,000 shares of the Company’s common stock, par value $0.0001 per share (the “Common Stock” and, such shares underlying the Warrant, the “Warrant Shares”), at an exercise price equal to a 30% premium to the higher of (i) the volume weighted average price of the Common Stock on the Nasdaq Global Market for the 30 trading days preceding the issuance of such Warrant as reported by Bloomberg L.P. (based on a trading day from 9:30 a.m. (New York City time) to 4:02 p.m. (New York City time)) or (ii) the public offering price per share of the Common Stock in the Subsequent Offering (as defined below); provided, however, in no event shall the Exercise Price be below the “Minimum Price” as such term is defined in Nasdaq Listing Rule 5635(d). The exercise price of the Warrant and the number of Warrant Shares issuable upon exercise of the Warrant are subject to adjustments for stock splits, combinations, stock dividends or similar events. Pursuant to the terms of the Warrant, the Warrant Shares shall vest and become exercisable as follows: (i) 1,142,857 of the Warrant Shares (the “FirstTranche”) shall vest on the issue date of the Warrant; however, the Warrant may not be exercised for six months after the issuance of the Warrant, which is expected to occur on the date of the closing of the Subsequent Offering (the “Initial ExerciseDate”) and (ii) 857,143 of the Warrant Shares shall vest on the date of payment of the Second Installment. In the event that the Second Installment is not paid, the Warrant shall only be exercisable with respect to the First Tranche. The Warrant will be exercisable for ten years from the date of issuance.
Concurrent with the execution of the Revenue Purchase and Sale Agreement, the Purchaser also agreed to purchase $5.0 million of shares of Common Stock (the “Ligand Private PlacementShares”) pursuant to a stock purchase agreement, dated as of July 31, 2025, between the Company and the Purchaser (the “LigandStock Purchase Agreement”), at a purchase price per share equal to the public offering price per share in the Company’s next public offering of its equity securities (the “Subsequent Offering”). The closing of the Ligand Stock Purchase Agreement is contingent upon, among other things, the receipt by the Company of gross proceeds of at least $30,000,000 in the aggregate pursuant to (a) the Subsequent Offering and (b) the terms of the Medtronic Stock Purchase Agreement (as defined below). The Ligand Stock Purchase Agreement contains customary representations and warranties of the Company and the Purchaser, and customary covenants on the part of the Company.
The foregoing descriptions of the Revenue Purchase and Sale Agreement, the Ligand Stock Purchase Agreement and the Warrant are summaries only, do not purport to be complete, and are qualified in their entirety by the full terms and conditions of the Revenue Purchase and Sale Agreement, the Ligand Stock Purchase Agreement and the Warrant. The Revenue Purchase and Sale Agreement, the Ligand Stock Purchase Agreement and the form of Warrant are filed as Exhibits 10.1, 10.2 and 4.1, respectively, to this Current Report on Form 8-K (this “Current Report”) and are incorporated herein by reference.
Purhase of Shares by Medtronic and Loan Agreementwith Medtronic
On July 31, 2025, the Company and its wholly-owned subsidiaries, Orchestra BioMed, Inc. and BackBeat Medical, LLC (“BackBeat Medical”), entered into a Loan Agreement (the “Loan Agreement”) with Medtronic Inc. (“Medtronic”), pursuant to which Medtronic agreed to extend a convertible loan to the Company in the aggregate original principal amount of $20.0 million (the “Loan”). The Loan is evidenced by a secured subordinated convertible promissory note (the “Note”) of the Company. The issuance of the Note to Medtronic and the funding of the Loan will take place on April 27, 2026 subject to certain closing conditions as described in the Loan Agreement.
The Note will accrue simple interest at a rate of 11% per annum. The Note does not allow for prepayment without the prior consent of Medtronic. Unless earlier converted, or redeemed, the Note will mature on April 27, 2031 (the “Repayment Date”). In addition, the payment or other satisfaction of the obligations set forth in the Loan Agreement are subordinate in right of payment to the prior payment in full of the senior obligations. The obligations arising under the Loan Agreement and the Note are secured by security interests in, and pledges over, the Company’s assets, subject to certain agreed security principles, permitted liens and other customary exceptions and qualifications.
The principal balance of the Note, together with all accrued and unpaid interest thereon (collectively, the “Balance”) will automatically convert into a revenue share (the “Revenue Share Credit”), if U.S. Food and Drug Administration (“FDA”) approval of a Medtronic device incorporating AVIM is achieved prior to the Repayment Date. Upon conversion of the then outstanding Balance the Company shall pay to Medtronic the Revenue Share Credit, which shall equal 15% of the revenue share amounts that the Company receives under the Exclusive License and Collaboration Agreement (the “Collaboration Agreement”), by and among the Company, BackBeat Medical, LLC and Medtronic, dated June 30, 2022, until such time as the total Revenue Share Credit payments equal $40.0 million.
The Loan Agreement contains customary representations, warranties and affirmative and negative covenants. In addition, the Loan Agreement contains customary events of default that entitle Medtronic to cause the Company’s indebtedness under the Note to become immediately due and payable, and to exercise remedies against the Company and the collateral securing the Loan. Upon the occurrence and for the duration of an event of default, an additional default interest rate equal to 2.0% per annum may apply to all obligations owed under the Loan Agreement.
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In addition, concurrently with the execution of the Loan Agreement, Medtronic, through its affiliate Covidien Group S.à.r.l. (“Covidien”) has agreed to purchase an aggregate amount of up to $12.0 million of shares of Common Stock (the “Medtronic Private Placement Shares” and, together with the Ligand Private Placement Shares, the “Private Placement Shares”) pursuant to a stock purchase agreement, dated as of July 31, 2025, between the Company and Covidien (the “Medtronic Stock Purchase Agreement” and, together with the Ligand Stock Purchase Agreement, the “Stock Purchase Agreements”), at a purchase price per share equal to the public offering price per share in the Subsequent Offering. The Medtronic Private Placement Shares will consist of (i) $10.0 million of shares of Common Stock and (ii) additional shares of Common Stock on a proportional basis equal to 0.05714 multiplied by the amount of gross proceeds raised in the Subsequent Offering in excess of $35.0 million, up to a cap of $2.0 million. The closing of Medtronic Stock Purchase Agreement is contingent upon, among other things, the occurrence of the closing of the Subsequent Offering and the simultaneous closing of the Ligand Private Placement resulting in the receipt by the Company of gross proceeds of at least $25,000,000 in the aggregate. The Medtronic Stock Purchase Agreement contains customary representations and warranties of the Company and Medtronic, and customary covenants on the part of the Company.
The foregoing descriptions of the Loan Agreement, the Note and the Medtronic Stock Purchase Agreement are summaries only, do not purport to be complete, and are qualified in their entirety by the full terms and conditions of the Loan Agreement, the Note and the Medtronic Stock Purchase Agreement. The Loan Agreement, the Note and the Medtronic Stock Purchase Agreement are filed as Exhibits 10.3, 10.4 and 10.5, respectively, to this Current Report and are incorporated herein by reference.
Amendment of Exclusive License and CollaborationAgreement
On July 31, 2025, the Company, BackBeat Medical and Medtronic entered into an amendment (the “Amendment”) to the Collaboration Agreement to provide, among other things, a development and commercialization framework for future AVIM-therapy integration into a dual-chamber leadless pacemaker.
Closing of the Amendment will be subject to customary conditions for a transaction of this type as well as: (i) the closing of the Revenue Purchase and Sale Agreement; (ii) the closing of the Medtronic Stock Purchase Agreement; (iii) the receipt by the Company of (or contractual right of the Company to receive) gross proceeds of $35.0 million in the aggregate pursuant to (a) the Subsequent Offering, (b) the terms of the Medtronic Stock Purchase Agreement and (c) the terms of the Ligand Stock Purchase Agreement; and (iv) the proceeds from the Note being used solely for the continued funding and support of the ongoing BACKBEAT clinical study and such other activities directly associated with the BACKBEAT clinical study and the Collaboration Agreement.
The foregoing description of the Amendment is a summary only, does not purport to be complete, and is qualified in its entirety by the full terms and conditions of the Amendment, a copy of which is expected to be filed as an exhibit to the Company’s next quarterly report on Form 10-Q.
Amendments to Hercules Loan and Security Agreementand Warrant Agreements
On July 31, 2025, the Company, certain of its subsidiaries, the lenders named therein (the “Hercules Lenders”) and Hercules Capital, Inc. (“Hercules”) entered into that certain second amendment (the “LSA Amendment”) to the Loan and Security Agreement, dated as of November 6, 2024, as amended by that certain First Amendment to Loan and Security Agreement dated as of December 30, 2024 (the “Loanand Security Agreement”), which, among other things, amended the existing Loan and Security Agreement to (i) delay the initial date upon which the Company has to begin amortizing term loans under the Loan and Security Agreement from (a) December 1, 2026 (with amortization payments delayed to as late December 1, 2027 if certain conditions were met) to (b) July 1, 2027 (with amortization payments delayed to as late as January 1, 2028 if certain conditions are met); and (ii) increase by $15,000,000 (from $20,000,000 to $35,000,000) the amount that that may be borrowed by the Company in the discretion of the lender’s investment committee’s and (iii) eliminate the Company’s ability to draw up to $15,000,000 if certain milestones are achieved.
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Effectiveness of the LSA Amendment will be subject to customary conditions for a transaction of this type as well as: (i) delivery of the Warrant Agreement Amendments (as defined below), (ii) the receipt by the Company of (or contractual right of the Company to receive) gross proceeds of $70.0 million in the aggregate pursuant to (a) the Subsequent Offering, (b) the Stock Purchase Agreements, (c) the Revenue Purchase and Sale Agreement, and (d) the Loan Agreement and (iii) the closing of the Revenue Purchase and Sale Agreement.
In addition, concurrently with the effectiveness of the LSA Amendment, the Company will enter into amendments to the warrant agreements it entered on November 6, 2024 (the “HerculesWarrant Agreements”) with the lenders under the Loan and Security Agreement (the “Warrant Agreement Amendments”). As a result of the Warrant Agreement Amendments, among other things:
| · | the exercise price under the Hercules Warrant Agreements (“Exercise Price”) will go from $5.74<br>to the lower of (i) $5.74 and (ii) 130% of the lowest effective price paid per share of Common Stock in the Company’s Next Equity<br>Financing (as such term is defined in the Warrant Agreement Amendments); and |
|---|---|
| · | the number of shares issuable upon exercise of the Hercules Warrant Agreements will go from (a) 2% of<br>aggregate principal amount of Term Loan Advances (as defined in the Loan and Security Agreement) divided by the Exercise Price to (b)<br>4% of aggregate principal amount of Term Loan Advances divided by the Exercise Price. |
| --- | --- |
The foregoing description of the LSA Amendment and the Warrant Agreement Amendments are summaries only, do not purport to be complete, and are qualified in their entirety by the full terms and conditions of the LSA Amendment and Warrant Agreement Amendments, respectively. The LSA Amendment and form of Warrant Agreement Amendments are filed as Exhibits 10.6 and 4.1, respectively, to this Current Report and are incorporated herein by reference.
Registration Rights Agreement
In connection with the Stock Purchase Agreements and the Warrant, the Company, the Purchaser and Medtronic have agreed to enter into a Registration Rights Agreement in the form attached to the Stock Purchase Agreements (the “Registration Rights Agreement”) at the Closing, pursuant to which the Company will agree to file a shelf registration statement (the “Registration Statement”) providing for the resale of the Private Placement Shares and the Warrant Shares within 90 calendar days of the closing of the Stock Purchase Agreements, to use its commercially reasonable efforts to cause the Registration Statement to be declared effective after its filing at the earliest possible date, but no later than the earlier of (i) the 180^th^ calendar day following the issuance of the Private Placement Shares, if the Securities and Exchange Commission (“SEC”) notifies the Company that it will “review” the Registration Statement and (ii) the 5^th^ business day after the date the Company is notified by the SEC that the Registration Statement will not be “reviewed” or will be subject to no further review, and to maintain the effectiveness of such registration statement until the date as of which there are no longer any Registrable Securities (as such term is defined in the Registration Rights Agreement).
The foregoing description of the Registration Rights Agreement is a summary only, does not purport to be complete, and is qualified in its entirety by the full terms and conditions of the Registration Rights Agreement. The form of Registration Rights Agreement is filed as Exhibit 10.7 to this Current Report and is incorporated herein by reference.
Item 2.03. Creation of Direct Financial Obligation or an Obligationunder an Off-Balance Sheet Arrangement of a Registrant.
The information required by this item with respect to the Loan Agreement, the Note and the LSA Amendment is included in Item 1.01 hereto and is incorporated herein by reference.
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Item 3.02. Unregistered Sales of Equity Securities.
The information required by this item with respect to the Warrant, the Warrant Shares and the Private Placement Shares is included in Item 1.01 hereto and is incorporated herein by reference. The issuance of the Warrant, the Warrant Shares and the Private Placement Shares is exempt from the requirements of the Securities Act of 1933, as amended (the “Securities Act”), pursuant to an exemption provided by Section 4(a)(2) thereof as transactions by an issuer not involving a public offering.
Item 7.01. Regulation FD Disclosure.
On July 31, 2025, the Company issued a press release announcing, among other things, the Revenue Purchase and Sale Agreement, the Loan Agreement, the Amendment, the LSA Amendment and the Stock Purchase Agreements. A copy of the press release is attached to this Current Report as Exhibit 99.1 and is incorporated herein solely for purposes of this Item 7.01 disclosure.
The information in Item 7.01 of this Current Report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such section. The information in Item 7.01 of this Current Report, including Exhibit 99.1, shall not be incorporated by reference into any filing under the Securities Act or the Exchange Act, regardless of any incorporation by reference language in any such filing.
Item 8.01. Other Information.
Certain Unaudited Preliminary June 30, 2025Financial Results
Although the Company’s financial results for the quarter ended June 30, 2025 are not yet finalized, based on currently available information, the Company expects its cash, cash equivalents and short-term investments to be approximately $33.9 million as of June 30, 2025.
The preliminary results set forth above are based on management’s initial review of the Company’s operations for the quarter ended June 30, 2025 and are subject to completion of financial closing procedures. The preliminary financial results in this Current Report have been prepared by, and are the responsibility of, management. Actual results may differ materially from these preliminary results as a result of the completion of financial closing procedures, final adjustments, and other developments arising between now and the time that the Company’s financial results are finalized. In addition, these preliminary results are not a comprehensive statement of the Company’s financial results for the quarter ended June 30, 2025, should not be viewed as a substitute for full financial statements prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the Company’s results for any future period. Ernst & Young LLP, the Company’s independent registered public accounting firm, has not audited, reviewed, compiled, or applied agreed-upon procedures with respect to the preliminary financial results. Accordingly, Ernst & Young LLP does not express an opinion or any other form of assurance with respect thereto.
Terumo Agreement
As previously disclosed, the Company is in a mediation procedure with Terumo Corporation and Terumo Medical Corporation (collectively, “Terumo”) pursuant to the distribution agreement, dated June 13, 2019, by and among the Company and Terumo (the “Terumo Agreement”)and the International Mediation Rules of the International Centre for Dispute Resolution (“ICDR”). The mediation is intended to assist in potentially resolving disagreements and facilitating the completion of negotiations related to restructuring, replacing or terminating the Terumo Agreement. The Terumo Agreement provides that matters that are not resolved through mediation are to be resolved by binding arbitration conducted under the auspices of the ICDR in accordance with its International Arbitration Rules. If the mediation does not lead to a timely agreement or resolution, or, if applicable, the Company does not prevail in arbitration, or if the Terumo Agreement is terminated, the Company’s commercialization plans for Virtue SAB may be adversely impacted. However, any termination of the Terumo Agreement in the context of mediation, an arbitration or otherwise would allow the Company to pursue an alternative strategic collaboration or other transaction with a different partner. The Company currently expects the formal mediation to be completed by the end of the third quarter of 2025. Regardless of the mediation process with Terumo, the Company intends to initiate enrollment of the Virtue SAB trial, its pivotal study of Virtue SAB for coronary in-stent restenosis in the U.S. during the second half of 2025, as well as to continue other product development efforts related to Virtue SAB.
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Update on BACKBEATStudy
As previously disclosed, the Company estimated completion of enrollment of the BACKBEAT global pivotal study (the “BACKBEAT Study”) in the first half of 2026. The Company currently expects enrollment of the BACKBEAT study to be completed in mid-2026.
Further, as previously disclosed, during the third quarter of 2024, we implemented an FDA-approved amendment to the BACKBEAT study protocol for existing and newly activated study sites. The Company is also in the process of implementing additional FDA-approved amendments to the BACKBEAT global pivotal study that are expected to significantly expand patient eligibility at participating clinical sites as well as streamline patient screening and study workflow.
Forward-Looking Statements
Certain statements includedin this Current Report that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under theUnited States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate futureevents or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statementsrelating to the potential efficacy, safety and commercial value of the Company’s commercial product candidates, the payment of theSecond Installment, the Company’s ability to satisfy the closing conditions of the transactions described in his Current Report,the affect of the FDA-approved amendments to the BACKBEAT global pivotal study on patient eligibility, patient screening and study workflow,the timing of the funding of the Loan Agreement, the date of completion of the formal mediation, and the expected date of completion ofenrollment of the BackBeat study. These statements are based on various assumptions, whether or not identified in this Current Report,and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-lookingstatements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance,a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predictand may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statementsare subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political,and legal conditions; risks related to regulatory approval of the Company’s product candidates; the timing of, and the Company’sability to achieve, expected regulatory and business milestones; the impact of competitive products and product candidates; and the riskfactors discussed under the heading “Item 1A. Risk Factors” in the Company’s annual report on Form 10-K filed with theU.S. Securities and Exchange Commission on March 31, 2025, as updated by the risk factors discussed under the heading “Item 1A.Risk Factors” in the Company’s quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission on May12, 2025, and as further updated by any risk factors disclosed under the heading “Item 1A. Risk Factors” in the Company’ssubsequently filed quarterly reports on Form 10-Q.
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Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Certain of the exhibits and schedules to this Exhibit have been omitted in accordance with Regulation S-K Item 601. The Registrant agrees
to furnish a copy of all omitted exhibits and schedules to the SEC upon its request.
˄ Certain identified information has been omitted pursuant to Item 601(b)(10) of Regulation S-K because such information is both (i) not material and (ii) information that the Registrant treats as private or confidential. The Registrant hereby undertakes to furnish supplemental copies of the unredacted exhibit upon request by the SEC.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ORCHESTRA BIOMED HOLDINGS, INC. | ||
|---|---|---|
| By: | /s/ Andrew Taylor | |
| Name: | Andrew Taylor | |
| Title: | Chief Financial Officer | |
| Date: July 31, 2025 |
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Exhibit 4.1
NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR PURSUANT TO AN AVAILABLE EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN ACCORDANCE WITH APPLICABLE STATE SECURITIES LAWS.
COMMON STOCK PURCHASE WARRANT
ORCHESTRA BIOMED HOLDINGS, INC.
| Warrant Shares: 2,000,000 | Issue Date: July [●], 2025 |
|---|---|
| Initial Exercise Date: January [●], 2026 |
THIS COMMON STOCK PURCHASE WARRANT (this “Warrant”) certifies that, for value received, Ligand Pharmaceuticals Incorporated or its permitted assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the Initial Exercise Date and on or prior to 5:00 p.m. (New York City time) on [●], 2035 (the “Termination Date”)^1^ but not thereafter, to subscribe for and purchase from Orchestra Biomed Holdings, Inc., a Delaware corporation (the “Company”), up to 2,000,000 shares of the Company’s common stock, par value $0.0001 per share (“Common Stock”) (as subject to adjustment hereunder, the “Warrant Shares”); provided that this Warrant may only be exercised with respect to Warrant Shares that have Vested (as defined in Section 2(d) below). The purchase price of one share of Common Stock under this Warrant shall be equal to the Exercise Price, as defined in Section 2(b) below. Pursuant to the Registration Rights Agreement between the Company and the Holder, dated of even date herewith (the “RRA”), subject to the terms and conditions of the RRA, the Company expects to file a registration statement on Form S-3 (or, if Form S-3 is not available to the Company, any other form the Company is eligible to use) (as applicable, the “Registration Statement”) to register under the Securities Act of 1933, as amended (the “Securities Act”), the resale of any Warrant Shares issued to the Holder.
Section 1. Agreement. This Warrant is being issued pursuant to that certain Revenue Participation Right Purchase and Sale Agreement, dated July [●], 2025, by and between the Company and Holder (as may be amended or restated from time to time, the “Purchase and Sale Agreement”).
^1^ Ten years from the Issue Date.
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Section 2. Exercise.
(a) Exercise of Warrant. Exercise of the purchase rights represented by this Warrant may be made, in whole or in part, at any time or times on or after the Initial Exercise Date with respect to Warrant Shares that have Vested and on or before the Termination Date by delivery to the Company of a duly executed PDF copy submitted by e-mail (or e-mail attachment) of the Notice of Exercise in the form annexed hereto as Exhibit A (the “Notice of Exercise”). Unless the cashless exercise procedure specified in Section 2(e) below (if available) is specified in the applicable Notice of Exercise, within two (2) Trading Days following the date of exercise as aforesaid, the Holder shall deliver to the Company the aggregate Exercise Price for the Warrant Shares specified in the applicable Notice of Exercise by wire transfer or cashier’s check drawn on a United States bank, and the date on which such Exercise Price is delivered to the Company is an “Exercise Date,” provided that if the cashless exercise procedure specified in Section 2(e) below is specified in the applicable Notice of Exercise, the Exercise Date shall be the date the Notice of Exercise is delivered to the Company. No ink-original Notice of Exercise shall be required, nor shall any medallion guarantee (or other type of guarantee or notarization) of any Notice of Exercise be required. Notwithstanding anything herein to the contrary, the Holder shall not be required to physically surrender this Warrant to the Company. Partial exercises of this Warrant resulting in purchases of a portion of the total number of Warrant Shares available hereunder shall have the effect of lowering the outstanding number of Warrant Shares purchasable hereunder in an amount equal to the applicable number of Warrant Shares purchased in connection with such partial exercise. The Holder and the Company shall maintain records showing the number of Warrant Shares purchased and the date of such purchases. The Company shall deliver any objection to any Notice of Exercise within one (1) Trading Day of receipt of such notice. **The Holder and any assignee, by acceptance of this Warrant,acknowledge and agree that, by reason of the provisions of this paragraph, following the purchase of a portion of the Warrant Shares hereunder,the number of Warrant Shares available for purchase hereunder at any given time may be less than the amount stated on the face hereof.**For purposes of this Warrant, “Trading Day” means any day on which the Common Stock is purchased and sold on the principal market on which the Common Stock is listed or quoted (the “Trading Market”).
(b) Exercise Price. The exercise price per share of Common Stock under this Warrant shall be $[●]^2^, subject to adjustment hereunder (the “Exercise Price”).
(c) Mechanics of Exercise.
(i) Delivery of Warrant Shares Upon Exercise. The Company shall cause the Warrant Shares purchased hereunder (the “Exercise Shares”) to be transmitted by its transfer agent to the Holder (i) by crediting the account of the Holder’s or its designee’s balance account with The Depository Trust Company through its Deposit or Withdrawal at Custodian system (“DWAC”) if the Company is then a participant in such system and there is an effective registration statement permitting the issuance of the Warrant Shares to the Holder and (ii) otherwise by delivering evidence of issuance of the Warrant Shares in book entry with the Company’s transfer agent, registered in the Company’s share register in the name of the Holder or its designee, for the number of Warrant Shares to which the Holder is entitled pursuant to such exercise to the address specified by the Holder in the Notice of Exercise (or, evidence of such book entry issuance to the email address specified in such Notice of Exercise) by the date that is no less than the number of Trading Days comprising the Standard Settlement Period following the Exercise Date. The Holder shall be deemed for all corporate purposes to have become the holder of record of the Warrant Shares with respect to which this Warrant has been exercised as of the Exercise Date, irrespective of the date such Warrant Shares are credited to the Holder’s Depository Trust Company account or the date of the book entry positions evidencing such Warrant Shares. For purposes of this Warrant, “Standard Settlement Period” means the standard settlement period, expressed in a number of Trading Days, for the Trading Market with respect to the Common Stock that is in effect on the date of delivery of an applicable Exercise Notice, which as of the Issue Date was “T+1.”
^2^ NTD: The exercise price shall be a 30% premium to the higher of a) the volume weighted average price of the Common Stock on the Nasdaq Global Market for the 30 trading days preceding the issuance of such warrants as reported by Bloomberg L.P. (based on a Trading Day from 9:30 a.m. (New York City time) to 4:02 p.m. (New York City time)) or b) the price per share of the Company’s contemplated public offering; provided, however, in no event shall the Exercise Price be below the “Minium Price” as such term is defined in Nasdaq Listing Rule 5635(d).
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(ii) Buy-In. In addition to any other rights available to the Holder, if the Company fails to cause the transfer agent to deliver to the Holder or its designee Exercise Shares in the manner required pursuant to Section 2(c)(i) within the Standard Settlement Period following the Exercise Date (other than a failure caused by incorrect or incomplete information provided by the Holder to the Company) and the Holder or the Holder’s broker on its behalf purchases (in an open market transaction or otherwise) shares of Common Stock to deliver in satisfaction of a sale by the Holder of the Warrant Shares which the Holder anticipated receiving upon such exercise (a “Buy-In”) but did not receive within the Standard Settlement Period, then the Company shall, within two (2) Trading Days after the Holder’s request (i) pay cash to the Holder in an amount equal to the excess (if any) of the Holder’s total purchase price (including brokerage commissions, if any) for the shares of Common Stock so purchased in the Buy-In, less the product of (A) the number of shares of Common Stock purchased in the Buy-In, times (B) the Closing Sale Price (as defined below) of a share of Common Stock on the Exercise Date and (ii) in the Holder’s sole discretion, either reinstate the portion of the Warrant and equivalent number of Warrant Shares for which such exercise was not honored (in which case such exercise shall be deemed rescinded) or promptly honor its obligation to deliver to the Holder or its designee the Exercise Shares pursuant to Section 2(c)(i). The Holder shall provide the Company written notice promptly after the occurrence of a Buy-In, including the amounts payable to the Holder in respect of the Buy-In together with applicable confirmations and other evidence reasonably requested by the Company.
(iii) Delivery of New Warrants Upon Exercise. If this Warrant shall have been exercised in part, the Company shall, at the request of Holder and upon surrender of this Warrant certificate, at the time of delivery of the Warrant Shares, deliver to the Holder a new Warrant evidencing the rights of the Holder to purchase the unpurchased Warrant Shares called for by this Warrant, which new Warrant shall in all other respects be identical with this Warrant.
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(iv) No Fractional Shares or Scrip. No fractional shares or scrip representing fractional shares shall be issued upon the exercise of this Warrant. As to any fraction of a share which the Holder would otherwise be entitled to purchase upon such exercise, the Company shall pay a cash adjustment in respect of such final fraction in an amount equal to such fraction multiplied by the fair market value (based on the Closing Sale Price) for any such fractional shares.
(v) Charges, Taxes and Expenses. Issuance of Warrant Shares shall be made without charge to the Holder for any issue or transfer tax or other incidental expense in respect of the issuance of such Warrant Shares, all of which taxes and expenses shall be paid by the Company, and such Warrant Shares shall be issued in the name of the Holder or in such name or names as may be directed by the Holder; provided, however, that in the event that Warrant Shares are to be issued in a name other than the name of the Holder, this Warrant when surrendered for exercise shall be accompanied by the Assignment Form attached hereto as Exhibit B duly executed by the Holder and the Company may require, as a condition thereto, the payment of a sum sufficient to reimburse it for any transfer tax incidental thereto. The Company shall pay all transfer agent fees required for same-day processing of any Notice of Exercise and all fees to the Depository Trust Company (or another established clearing corporation performing similar functions) required for same-day electronic delivery of the Warrant Shares.
(vi) Closing of Books. The Company will not close its stockholder books or records in any manner which prevents the timely exercise of this Warrant, pursuant to the terms hereof.
(d) Vested Warrants.
(i) The Warrant Shares shall vest as follows (upon such vesting, such Warrants Shares shall be “Vested”): (a) 1,142,857 of the Warrant Shares (the “First Tranche”) shall vest as of the Issue Date and (ii) 857,143 of the Warrant Shares (the “Second Tranche”) shall vest on the date of payment of the Second Installment (as such term is defined in the Purchase and Sale Agreement) pursuant to the terms and conditions of the Purchase and Sale Agreement.
(ii) In the event that the Second Installment is not paid, this Warrant shall only be exercisable with respect to the First Tranche.
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(e) Cashless Exercise if Registration Statement Not Available. If, and only if, at the time of exercise of this Warrant the Registration Statement is not effective (or the prospectus contained therein is not available for use) for the resale of all of the Warrant Shares that can be issued pursuant to this Warrant, then the Holder may, in lieu of payment of the Exercise Price in the manner as specified in Section 2(a) above, but otherwise in accordance with the requirements of Section 2(a), at its option, exercise this Warrant, in whole or in part, by means of a “cashless exercise” in which the Holder shall be entitled to receive, and the Company shall issue to the Holder, such number of fully paid and non-assessable Warrant Shares determined as follows: X = Y[(A-B)/A] (“Cashless Exercise”), where:
(X) = the number of Warrant Shares to be issued to the Holder;
(A) = the Closing Sale Price (as defined below) of the shares of Common Stock (as of the Trading Day on the date immediately preceding the Exercise Date;
(B) = the Exercise Price of this Warrant, as adjusted hereunder; and
(Y) = the number of Warrant Shares that would be issuable upon exercise of this Warrant in accordance with the terms of this Warrant if such exercise were by means of a cash exercise pursuant to Section 2(a) rather than a cashless exercise.
For purposes of this Warrant, “Closing Sale Price” means, for any security as of any date, the last trade price for such security on the principal Trading Market for such security, as reported by Bloomberg Financial Markets, or, if such Trading Market begins to operate on an extended hours basis and does not designate the last trade price, then the last trade price of such security prior to 4:00 P.M., New York City time, as reported by Bloomberg Financial Markets, or if the foregoing do not apply, the last trade price of such security in the over-the-counter market on the electronic bulletin board for such security as reported by Bloomberg Financial Markets. If the Closing Sale Price cannot be calculated for a security on a particular date on any of the foregoing bases, the Closing Sale Price of such security on such date shall be the fair market value as mutually determined by the Company and the Holder.
For purposes of Rule 144, it is intended, understood and acknowledged that the Warrant Shares issued in a cashless exercise transaction shall be deemed to have been acquired by the Holder, and the holding period for the Warrant Shares shall be deemed to have commenced, on the date this Warrant was originally issued (provided that the Securities and Exchange Commission (the “Commission”) continues to take the position that such treatment is proper at the time of such exercise).
If Warrant Shares are issued in such a cashless exercise, the parties acknowledge and agree that in accordance with Section 3(a)(9) of the Securities Act, the holding period of the Warrant Shares being issued may be tacked on to the holding period of this Warrant. The Company agrees not to take any position contrary to this Section 2(d).
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Section 3. Certain Adjustments.
(a) Stock Dividends and Splits. If the Company, at any time while this Warrant is outstanding: (i) pays a stock dividend on its Common Stock or otherwise makes a distribution or distributions on shares of its Common Stock or any other equity or equity equivalent securities payable in shares of Common Stock (which, for avoidance of doubt, shall not include any shares of Common Stock issued by the Company upon exercise of this Warrant), (ii) subdivides outstanding shares of Common Stock into a larger number of shares, (iii) combines (including by way of reverse stock split) outstanding shares of Common Stock into a smaller number of shares, or (iv) issues by reclassification of shares of Common Stock any shares of capital stock of the Company, then in each case the number of Warrant Shares shall be multiplied by a fraction of which the numerator shall be the number of shares of Common Stock (excluding treasury shares, if any) outstanding immediately after such event and of which the denominator shall be the number of shares of Common Stock outstanding immediately before such event. Any adjustment made pursuant to this Section 3(a) shall become effective immediately after the record date for the determination of stockholders entitled to receive such dividend or distribution and shall become effective immediately after the effective date in the case of a subdivision, combination or re-classification; provided, however, if an adjustment is made immediately after the record date for the determination of stockholders entitled to receive a dividend or distribution but such dividend or distribution is not so made, the number of Warrant Shares shall be readjusted, effective as of the date the Company’s Board of Directors determines not to make such dividend or distribution, to the number of Warrant Shares issuable upon exercise of this Warrant that would then be in effect at such time had no such adjustment been made.
(b) Rights Upon Distribution of Assets. If, on or after the Issue Date and on or prior to the Termination Date, the Company shall declare or make any dividend or other pro rata distribution of its assets (or rights to acquire its assets) to holders of shares of Common Stock, by way of return of capital or otherwise (including, without limitation, any distribution of cash, stock or other securities, property, options, evidence of indebtedness or any other assets by way of a dividend, spin off, reclassification, corporate rearrangement, scheme of arrangement or other similar transaction, but, for the avoidance of doubt, excluding any distribution of shares of Common Stock subject to Section 3(a) and any Fundamental Transaction subject to Section 3(c) (a “Distribution”), then, in each such case, the Exercise Price shall be adjusted by multiplying the Exercise Price in effect immediately prior to the record date fixed for determination of stockholders entitled to receive such Distribution by a fraction, of which the denominator shall be the Closing Sale Price determined as of the record date, and of which the numerator shall be such Closing Sale Price on such record date less the then per share fair market value at such record date of the portion of such Distribution so distributed applicable to one outstanding share of the Common Stock as determined by the Board of Directors of the Company in good faith. The adjustment shall be described in a statement provided to the Holder. Such adjustment shall be made whenever any such Distribution is made and shall become effective immediately after the applicable record date.
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(c) Fundamental Transactions. If, at any time while this Warrant is outstanding (i) the Company effects any merger or consolidation of the Company with or into another Person, in which the Company is not the surviving entity or in which the stockholders of the Company immediately prior to such merger or consolidation do not own, directly or indirectly, at least 50% of the voting power of the surviving entity immediately after such merger or consolidation, (ii) the Company effects any sale to another Person of all or substantially all of its assets in one or a series of related transactions, (iii) pursuant to any tender offer or exchange offer (whether by the Company or another Person), holders of capital stock tender shares representing more than 50% of the voting power of the capital stock of the Company and the Company or such other Person, as applicable, accepts such tender for payment, (iv) the Company consummates a stock purchase agreement or other business combination (including, without limitation, a reorganization, recapitalization, spin-off or scheme of arrangement) with another Person whereby such other Person acquires more than 50% of the voting power of the capital stock of the Company (except for any such transaction in which the stockholders of the Company immediately prior to such transaction maintain, in substantially the same proportions, the voting power of such Person immediately after the transaction) or (v) the Company effects any reclassification of the Common Stock or any compulsory share exchange pursuant to which the Common Stock is effectively converted into or exchanged for other securities, cash or property (other than as a result of a subdivision or combination of shares of Common Stock covered by Section 3(a) above) (in any such case, a “Fundamental Transaction”), then following such Fundamental Transaction the Holder shall have the right to receive, upon exercise of this Warrant, the same amount and kind of securities, cash or property as it would have been entitled to receive upon the occurrence of such Fundamental Transaction if it had been, immediately prior to such Fundamental Transaction, the holder of the number of Vested Warrant Shares then issuable upon exercise of this Warrant(the “Alternate Consideration”). The Company shall not effect any Fundamental Transaction in which the Company is not the surviving entity or the Alternate Consideration includes securities of another Person unless (i) the Alternate Consideration is solely cash and the Company provides for the simultaneous “cashless exercise” of this Warrant pursuant to Section 2(e) above or (ii) prior to or simultaneously with the consummation thereof, any successor to the Company, surviving entity or other Person (including any purchaser of assets of the Company) shall assume the obligation to deliver to the Holder such Alternate Consideration as, in accordance with the foregoing provisions, the Holder may be entitled to receive, and the other obligations under this Warrant. The provisions of this paragraph (d) shall similarly apply to subsequent transactions analogous to a Fundamental Transaction type. For purposes of this Warrant, “Person” shall mean an individual, partnership, corporation, limited liability company, business trust, joint stock company, trust, incorporated or unincorporated association, joint venture, government (or an agency or subdivision thereof) or any other entity or organization.
(d) Number of Warrant Shares. Simultaneously with any adjustment to the number of Warrant Shares pursuant to Section 3, the Exercise Price shall be increased or decreased proportionately, so that after such adjustment the aggregate Exercise Price payable hereunder for the increased or decreased number of Warrant Shares shall be the same as the aggregate Exercise Price in effect immediately prior to such adjustment. Notwithstanding the foregoing, in no event may the Exercise Price be adjusted below the par value of the Common Stock then in effect.
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(e) Calculations. All calculations under this Section 3 shall be made to the nearest cent or the nearest 1/100th of a share, as the case may be. For purposes of this Section 3, the number of shares of Common Stock deemed to be issued and outstanding as of a given date shall be the sum of the number of shares of Common Stock (excluding treasury shares, if any) issued and outstanding.
(f) Notice to Holder.
(i) Adjustment to Exercise Price. Whenever the Exercise Price is adjusted pursuant to any provision of this Section 3, the Company shall promptly deliver to the Holder by e-mail a notice setting forth the Exercise Price after such adjustment and any resulting adjustment to the number of Warrant Shares and setting forth a brief statement of the facts requiring such adjustment.
(ii) Notice to Allow Exercise by Holder. If (A) the Company shall declare a dividend (or any other distribution in whatever form) on the Common Stock, (B) the Company shall declare a special nonrecurring cash dividend on or a redemption of the Common Stock, (C) the Company shall authorize any Distribution, (D) the approval of any stockholders of the Company shall be required in connection with any reclassification of the Common Stock, any consolidation or merger to which the Company is a party, any sale or transfer of all or substantially all of the assets of the Company, or any compulsory share exchange whereby the Common Stock is converted into other securities, cash or property or any Fundamental Transaction, or (E) the Company shall authorize the voluntary or involuntary dissolution, liquidation or winding up of the affairs of the Company, then, in each case, the Company shall cause to be delivered by e-mail to the Holder at its last e-mail address as it shall appear upon the Warrant Register of the Company, at least 20 calendar days prior to the applicable record or effective date hereinafter specified, a notice of such transaction in order to enable the Holder to participate in or vote with respect to such transaction; provided that the failure to deliver such notice or any defect therein or in the delivery thereof shall not affect the validity of the corporate action required to be specified in such notice. To the extent that any notice provided in this Warrant constitutes, or contains, material, non-public information regarding the Company or any of its subsidiaries, the Company shall simultaneously file such notice with the Commission pursuant to a Current Report on Form 8-K. The Holder shall remain entitled to exercise this Warrant during the period commencing on the date of such notice to the effective date of the event triggering such notice except as may otherwise be expressly set forth herein.
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Section 4. Representations and Covenants of the Holder. This Warrant has been entered into by the Company in reliance upon the following representations and covenants of the Holder:
(a) Investment Purpose. This Warrant and the Warrant Shares are being acquired for investment and not with a view to the sale or distribution of any part thereof, and the Holder has no present intention of selling or engaging in any public distribution of the same except pursuant to a registration under the Securities Act or an exemption from the registration requirements of the Securities Act. Holder is not a registered broker-dealer under Section 15 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or an entity engaged in a business that would require it to be so registered as a broker-dealer.
(b) Private Issue. The Holder understands (i) that the Warrant Shares are not registered under the Securities Act or qualified under applicable state securities laws on the ground that the issuance contemplated by this Warrant will be exempt from the registration and qualifications requirements thereof, and (ii) that the Company’s reliance on such exemption is predicated on the representations set forth in this Section 4.
(c) Risk of No Registration. Without in any way limiting the Company’s obligations under this Warrant, the Holder understands that if the Common Stock is not registered with the Commission pursuant to Section 12 of the Exchange Act or the Company is not required to file reports pursuant to Section 13(a) or Section 15(d) of the Exchange Act, or if a registration statement is not effective under the Securities Act covering the resale of the Warrant Shares when it desires to sell (i) the rights to purchase Common Stock pursuant to this Warrant or (ii) the Warrant Shares, as applicable, it may be required to hold such securities for an indefinite period. The Holder also understands that any sale of (A) its rights hereunder to purchase Warrant Shares or (B) Warrant Shares which might be made by it in reliance upon Rule 144 under the Securities Act may be made only in accordance with the terms and conditions of that Rule.
(d) Restricted Securities. The Holder understands that this Warrant and the Warrant Shares issuable upon exercise hereof have not been registered under the Securities Act or registered or qualified under the securities laws of any state, and are issued in reliance upon specific exemptions therefrom, which exemptions depend upon, among other things, the bona fide nature of the Holder’s investment intent as expressed herein. The Holder understands that the Company is under no obligation to so register or qualify this Warrant or the Warrant Shares, except to the extent provided in the RRA. The Holder understands that this Warrant and any Warrant Shares issued upon any exercise hereof are “restricted securities” within the meaning of Rule 144 promulgated under the Securities Act and must be held indefinitely unless subsequently registered under the Securities Act and registered or qualified under applicable state securities laws, unless exemptions from such registration and qualification are otherwise available.
(e) Accredited Investor. The Holder is, and on each date on which it exercises any portion of this Warrant it will be, an “accredited investor” as defined in Regulation D promulgated under the Securities Act.
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Section 5. Transfer of Warrant.
(a) Transferability. This Warrant and the Warrant Shares issued upon exercise hereof may not be transferred or assigned in whole or in part except in compliance with applicable federal and state securities laws by the transferor and the transferee (including, without limitation, the delivery of investment representation letters and legal opinions reasonably satisfactory to the Company or its transfer agent, as reasonably requested by the Company or such transfer agent). Subject to the immediately preceding sentence, the Holder may transfer all or part of this Warrant or the Warrant Shares to any transferee; provided, that in connection with any such transfer of this Warrant, Holder will give the Company notice of the portion of the Warrant being transferred, with the name, address and taxpayer identification number of the transferee in accordance with Exhibit B hereto, and the Holder will surrender this Warrant to the Company for reissuance to the transferee(s) (and to the Holder if applicable); and provided further, that any transferee of this Warrant shall make substantially the representations set forth in Section 4 above and shall agree in writing with the Company to be bound by all of the terms and conditions of this Warrant.
(b) New Warrants. This Warrant may be divided or combined with other Warrants upon presentation hereof at the aforesaid office of the Company, together with a written notice specifying the names and denominations in which new Warrants are to be issued, signed by the Holder or its agent or attorney. Subject to compliance with Section 5(a), as to any transfer which may be involved in such division or combination, the Company shall execute and deliver a new Warrant or Warrants in exchange for the Warrant or Warrants to be divided or combined in accordance with such notice. All Warrants issued on transfers or exchanges shall be dated the Issue Date of this Warrant and shall be identical with this Warrant except as to the number of Warrant Shares issuable pursuant thereto.
(c) Warrant Register. The Company shall register this Warrant, upon records to be maintained by the Company for that purpose (the “Warrant Register”), in the name of the record Holder hereof from time to time. The Company may deem and treat the registered Holder of this Warrant as the absolute owner hereof for the purpose of any exercise hereof or any distribution to the Holder, and for all other purposes, absent actual notice to the contrary.
(d) Removal of Legends. In connection with any sale or other transfer of Warrant Shares that complies with all applicable securities laws, and subject to the Company’s receipt from the Holder of customary representations and other documentation reasonably acceptable to the Company, the Company shall, within the Standard Settlement Period following any request therefor from the Holder, (A) deliver to the transfer agent irrevocable instructions that the transfer agent shall make a new, unlegended entry for such book entry position Warrant Shares and (B) cause its counsel to deliver to the transfer agent one or more opinions to the effect that the removal of such legends in such circumstances may be effected under the Securities Act if required by the transfer agent to effect the removal of the legends in accordance with the provisions hereof. The Company shall be responsible for the fees of its transfer agent.
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Section 6. Miscellaneous.
(a) No Rights as Stockholder Until Exercise; No Settlement in Cash. This Warrant does not entitle the Holder to any voting rights, dividends or other rights as a stockholder of the Company prior to the exercise hereof as set forth in Section 2(c). Without limiting the rights of a Holder to receive Warrant Shares on a Cashless Exercise, and to receive the cash payments contemplated pursuant to Section 2(c)(iv), in no event will the Company be required to net cash settle an exercise of this Warrant.
(b) Loss, Theft, Destruction or Mutilation of Warrant. The Company covenants that upon receipt by the Company of evidence reasonably satisfactory to it of the loss, theft, destruction or mutilation of this Warrant or any stock certificate relating to the Warrant Shares, and in case of loss, theft or destruction, of indemnity or security reasonably satisfactory to it (which, in the case of the Warrant, shall not include the posting of any bond), and upon surrender and cancellation of such Warrant or stock certificate, if mutilated, the Company will make and deliver a new Warrant or stock certificate of like tenor and dated as of such cancellation, in lieu of such Warrant or stock certificate.
(c) Saturdays, Sundays, Holidays, etc. If the last or appointed day for the taking of any action or the expiration of any right required or granted herein shall not be a Trading Day, then, such action may be taken or such right may be exercised on the next succeeding Trading Day.
(d) Authorized Shares.
The Company covenants that, during the period the Warrant is outstanding, it will reserve from its authorized and unissued Common Stock a sufficient number of shares to provide for the issuance of the Warrant Shares upon the exercise of any purchase rights under this Warrant. The Company further covenants that its issuance of this Warrant shall constitute full authority to its officers who are charged with the duty of issuing the necessary Warrant Shares upon the exercise of the purchase rights under this Warrant. The Company will take all such reasonable action as may be necessary to assure that such Warrant Shares may be issued as provided herein without violation of any applicable law or regulation, or of any requirements of the Trading Market upon which the Common Stock may be listed. The Company covenants that all Warrant Shares which may be issued upon the exercise of the purchase rights represented by this Warrant will, upon exercise of the purchase rights represented by this Warrant and payment for such Warrant Shares in accordance herewith, be duly authorized, validly issued, fully paid and nonassessable and free from all taxes, liens and charges created by the Company in respect of the issue thereof (other than taxes in respect of any transfer occurring contemporaneously with such issue).
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Except and to the extent as waived or consented to by the Holder, the Company shall not by any action, including, without limitation, amending its certificate of incorporation or through any reorganization, transfer of assets, consolidation, merger, dissolution, issue or sale of securities or any other voluntary action, avoid or seek to avoid the observance or performance of any of the terms of this Warrant, but will at all times in good faith assist in the carrying out of all such terms and in the taking of all such actions as may be necessary or appropriate to protect the rights of Holder as set forth in this Warrant against impairment. Without limiting the generality of the foregoing, the Company will (i) not increase the par value of any Warrant Shares above the amount payable therefor upon such exercise immediately prior to such increase in par value, (ii) take all such action as may be necessary or appropriate in order that the Company may validly and legally issue fully paid and nonassessable Warrant Shares upon the exercise of this Warrant and (iii) use commercially reasonable efforts to obtain all such authorizations, exemptions or consents from any public regulatory body having jurisdiction thereof, as may be, necessary to enable the Company to perform its obligations under this Warrant.
Before taking any action which would result in an adjustment in the number of Warrant Shares for which this Warrant is exercisable or in the Exercise Price, the Company shall obtain all such authorizations or exemptions thereof, or consents thereto, as may be necessary from any public regulatory body or bodies having jurisdiction thereof.
(e) Governing Law. All questions concerning the construction, validity, enforcement and interpretation of this Warrant shall be governed by and construed and enforced in accordance with the laws of the State of New York, without giving effect to conflict of laws principles thereof. Each party agrees that all legal proceedings concerning the interpretations, enforcement and defense of the transactions contemplated by this Warrant (whether brought against a party hereto or their respective affiliates, directors, officers, shareholders, partners, members, employees or agents) shall be brought and enforced in the New York Supreme Court, County of New York, or in the United States District Court for the Southern District of New York, and irrevocably submits to such jurisdiction, which jurisdiction shall be exclusive. Each party hereby irrevocably submits to the exclusive jurisdiction of the state and federal courts sitting in the City of New York, State of New York for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein, and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, that such suit, action or proceeding is improper or is an inconvenient venue for such proceeding. Each party hereby irrevocably waives personal service of process and consents to process being served in any such suit, action or proceeding by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Warrant and agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any other manner permitted by law. If either party shall commence an action, suit or proceeding to enforce any provisions of this Warrant, the prevailing party in such action, suit or proceeding shall be reimbursed by the other party for their reasonable attorneys’ fees and other costs and expenses incurred with the investigation, preparation and prosecution of such action or proceeding.
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(f) Waiver of Jury Trial. Each party acknowledges and agrees that any controversy which may arise under this Warrant is likely to involvecomplicated and difficult issues and, therefore, each such party irrevocably and unconditionally waives any right it may have to a trialby jury in respect of any legal action arising out of or relating to this Warrant or the transactions contemplated hereby.
(g) Restrictions. The Holder acknowledges that the Warrant Shares acquired upon the exercise of this Warrant will have restrictions upon resale imposed by state and federal securities laws.
(h) Nonwaiver. No course of dealing or any delay or failure to exercise any right hereunder on the part of Holder shall operate as a waiver of such right or otherwise prejudice the Holder’s rights, powers or remedies.
(i) Notices. Any and all notices or other communications or deliveries to be provided by the Holder hereunder including, without limitation, any Notice of Exercise, shall be in writing and delivered personally, by e-mail, or sent by a nationally recognized overnight courier service, addressed to the Company, at Orchestra Biomed Holdings, Inc., 150 Union Square Drive, New Hope, Pennsylvania 18938, Attention: Chief Financial Officer, e-mail address: ataylor@orchestrabiomed.com, or such other number, e-mail address or address as the Company may specify for such purposes by written notice to the Holder. Any and all notices or other communications or deliveries to be provided by the Company hereunder shall be in writing and delivered personally, by e-mail, or sent by a nationally recognized overnight courier service addressed to the Holder at the e-mail address or address of such Holder appearing on the signature page to this Warrant or to such other address as the Holder may designate for itself by notice given in accordance with this Section 6(i). Any notice or other communication or deliveries hereunder shall be deemed given and effective on the earliest of (i) the time of transmission, if such notice or communication is delivered via e-mail at the e-mail address set forth in this Section 6(i) prior to 5:30 p.m. (New York City time) on any date, (ii) the next Trading Day after the time of transmission, if such notice or communication is delivered via e-mail at the e-mail address set forth in this Section 6(i) on a day that is not a Trading Day or later than 5:30 p.m. (New York City time) on any Trading Day, (iii) the second Trading Day following the date of mailing, if sent by U.S. nationally recognized overnight courier service, or (iv) upon actual receipt by the party to whom such notice is required to be given.
(j) Limitation of Liability. No provision hereof, in the absence of any affirmative action by the Holder to exercise this Warrant to purchase Warrant Shares, and no enumeration herein of the rights or privileges of the Holder, shall give rise to any liability of the Holder for the purchase price of any Common Stock or as a stockholder of the Company, whether such liability is asserted by the Company or by creditors of the Company.
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(k) Remedies. The Holder, in addition to being entitled to exercise all rights granted by law, including recovery of damages, will be entitled to specific performance of its rights under this Warrant. The Company agrees that monetary damages would not be adequate compensation for any loss incurred by reason of a breach by it of the provisions of this Warrant and hereby agrees to waive and not to assert the defense in any action for specific performance that a remedy at law would be adequate.
(l) Successors and Assigns. Subject to applicable securities laws, this Warrant and the rights and obligations evidenced hereby shall inure to the benefit of and be binding upon the successors and permitted assigns of the Company and the successors and permitted assigns of Holder. The provisions of this Warrant are intended to be for the benefit of any Holder from time to time of this Warrant and shall be enforceable by the Holder or holder of Warrant Shares.
(m) Amendment. This Warrant may be modified or amended or the provisions hereof waived with the written consent of the Company, on the one hand, and the Holder, on the other hand.
(n) Severability. Wherever possible, each provision of this Warrant shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Warrant shall be prohibited by or invalid under applicable law, such provision shall be ineffective to the extent of such prohibition or invalidity, without invalidating the remainder of such provisions or the remaining provisions of this Warrant.
(o) Headings. The headings used in this Warrant are for the convenience of reference only and shall not, for any purpose, be deemed a part of this Warrant.
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(Signature Page Follows)
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IN WITNESS WHEREOF, the parties hereto have caused this Warrant to be executed by their respective officers thereunto duly authorized as of the date first above indicated.
| ORCHESTRA BIOMED HOLDINGS, INC. | |
|---|---|
| By: | |
| Name: | Andrew Taylor |
| Title: | Chief Financial Officer |
| HOLDER | |
| --- | --- |
| By: | |
| Name: | [●] |
| Title: | [●] |
| Address of Holder: | |
| --- | |
| Email of Holder: |
15
EXHIBIT A
NOTICE OF EXERCISE
TO: ORCHESTRA BIOMED HOLDINGS, INC.
(1) The undersigned hereby elects to purchase ________ Warrant Shares of the Company pursuant to the terms of the attached Warrant, and tenders herewith payment of the exercise price in full, together with all applicable transfer taxes, if any.
(2) Payment shall take the form of (check applicable box):
¨ in lawful money of the United States; or
¨ the cancellation of such number of Warrant Shares as is necessary, in accordance with the formula set forth in Section 2(d) of the Warrant, to exercise the Warrant with respect to the cashless exercise procedure set forth in Section 2(d) of the Warrant.
(3) Please issue said Warrant Shares in the name of the undersigned or in such other name as is specified below:
_______________________________
The Warrant Shares (or the direct registration statement with respect to the Warrant Shares) shall be delivered to the following [DWAC Account Number][address and email]:
_______________________________
_______________________________
_______________________________
(4) The undersigned is an “accredited investor” as defined in Regulation D promulgated under the Securities Act of 1933, as amended.
HOLDER
| Signature of Authorized Signatory of Holder: |
|---|
| Name of Authorized Signatory: |
| --- |
| Title of Authorized Signatory: |
| --- |
| Date: |
| --- |
EXHIBIT B
ASSIGNMENT FORM
(To assign the foregoingWarrant, execute this form and supply required information. Do not use this form to purchase shares.)
FOR VALUE RECEIVED, the certain Warrant, dated July [●], 2025, issued by the Company to the Holder, and all rights evidenced thereby [with respect to [●] Warrant Shares] are hereby assigned to
| Name: | ||
|---|---|---|
| (Please Print) | ||
| Address: | (Please Print) | |
| Taxpayer Identification Number | ||
| Phone Number: | ||
| Email Address: | ||
| Dated: | , | |
| Holder’s Signature: | ||
| Holder’s Address: |
Exhibit 4.2
AMENDMENT NO. 1 TO WARRANT AGREEMENT
THIS AMENDMENT NO. 1 TO WARRANT AGREEMENT (this “Amendment”) is made this ___ day of July, 2025, by and between (“Holder”) and Orchestra BioMed Holdings, Inc., a Delaware corporation (the “Company”). Capitalized terms used herein, but not defined herein shall have the meanings set forth in the Warrant (as defined below).
WHEREAS, Holder is the holder of that certain Warrant Agreement dated November 6, 2024 issued by the Company to Holder (the “Warrant”); and
WHEREAS, in connection with certain credit transactions of even date herewith between Holder and the Company, the parties desire to amend the Warrant in the manner set forth below;
NOW, THEREFORE, in consideration of the premises and for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:
1. Amendment of Warrant. The Warrant is hereby amended as follows:
(a) by deleting the definition of Exercise Price in Section 1(b) thereof in its entirety, and substituting therefor the following new definition:
“ “Exercise Price” means the lower of (i) $5.74, and (ii) the Target Price, in either case subject to adjustment from time to time in accordance with the provisions of this Warrant.”
(b) by adding the following new defined terms to Section 1(b) thereof:
“ “Next Equity Financing” means the first sale and issuance by the Company after July 18, 2025, in a single transaction or series of related transactions, of shares of its Common Stock and/or convertible preferred stock to purchasers for cash in a bona fide equity financing of the Company in which the Company actually receives total aggregate gross cash proceeds of not less than $15,000,000, whether pursuant to an effective registration statement under the Act or in a transaction exempt from the registration requirements of the Act.”
“ “Next Equity Financing Price” means the lowest effective price per share for which shares of Common Stock are sold or issued, or deemed to have been sold or issued, by the Company in the Next Equity Financing; provided, however, with respect to an underwritten public offering registered under the Act, the lowest effective price per share shall refer to the price offered to the public, and not the price paid by the underwriters in such offering. For purposes of this definition:
(i) if the Company shall sell and issue a series of its convertible preferred stock in the Next Equity Financing, the Next Equity Financing Price therefor shall equal (A) the lowest effective price per share for which shares of such convertible preferred stock are sold or issued by the Company in the Next Equity Financing, divided by (ii) the number of shares of Common Stock into which a share of such convertible preferred stock may be converted; and
(ii) if warrants and/or other rights to acquire shares of Common Stock and/or convertible preferred stock are issued in connection with the Next Equity Financing, then the lowest effective price per share shall equal (A) the sum of (x) the total aggregate gross proceeds received by the Company from the sale and issuance of all shares of Common Stock and/or convertible preferred stock and all such warrants and/or other rights, and (y) the total aggregate exercise price or other purchase price payable under all such warrants and/or other rights, divided by (B) the sum of (x) the total aggregate number of (1) shares of Common Stock issued by the Company in the Next Equity Financing, and/or (2) shares of Common Stock issuable on conversion of the shares of convertible preferred stock issued by the Company in the Next Equity Financing, if any, and (y) the total aggregate number of (1) shares of Common Stock issuable on exercise of all such warrants and/or other rights, and/or (2) shares of Common Stock issuable on conversion of the shares of convertible preferred stock issuable on exercise of all such warrants and/or other rights, if any. Notwithstanding anything to the contrary contained herein, any warrants issued pursuant to the ”Revenue Participation Right Purchase and Sale Agreement, dated as of the date hereof, by and between Ligand Pharmaceuticals, Inc. and the Company, shall not be deemed to be issued in connection with the Next Equity Financing.
“ “Target Price” means one hundred thirty percent (130%) of the Next Equity Financing Price.”
(b) by amending and restating Section 1(c) in its entirety as follows (with such amendment and restatement to have effect as of the Effective Date):
“ (c) Number of Shares. This Warrant shall be exercisable for such number of shares of Common Stock as shall equal (i)(x) 0.04, multiplied by (y) the aggregate principal amount of all Term Loan Advances (as defined in the Loan Agreement) made to the Company by the Warrantholder as Lender, divided by (ii) the Exercise Price as in effect from time to time.”
2. Representations and Covenants of the Warrantholder. This Amendment is entered into by the Company in reliance in the representations and covenants of the Warrantholder set forth in Section 10 of the Warrant, which are incorporated herein by reference and deemed to be re-issued by the Warrantholder as of the date hereof.
3. No Adjustment Events. The Company represents and warrants that, since the Effective Date (as defined in the Warrant), there has occurred no event of a type described in Section 8 of the Warrant that resulted in an adjustment to the number or class of shares for which the Warrant is exercisable or the Exercise Price.
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4. No Other Amendments. Except as amended hereby, the Warrant shall remain in full force and effect as originally written.
5. Governing Law. This Amendment No. 1 shall be governed by and construed in accordance with (i) the General Corporation Law of the State of Delaware, as to all matters within its scope, and (ii) otherwise, the internal domestic laws of the State of New York, without giving effect to its principles regarding conflicts of law.
6. Electronic Signatures. Each party hereto may execute this Amendment No. 1 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..
[Remainder of page left blank intentionally]
[Signature page follows]
3
IN WITNESS WHEREOF, the parties have executed this Amendment No. 1 to Warrant Agreement as of the date first above written.
| ORCHESTRA BIOMED HOLDINGS, INC. | |
|---|---|
| By: | |
| Name: | Andrew Taylor |
| Title: | Chief Financial Officer |
| By: | |
| Name: | |
| Title: |
4
Exhibit 10.1
EXECUTION VERSION
REVENUE PARTICIPATION RIGHT
PURCHASE AND SALE AGREEMENT
BY AND BETWEEN
LIGAND PHARMACEUTICALS, INC.
AND
ORCHESTRA BIOMED HOLDINGS, INC.
DATED AS OF JULY 31, 2025
TABLE OF CONTENTS
Page
| Article 1 DEFINITIONS | 1 | |
|---|---|---|
| Section 1.1 | Definitions | 1 |
| Section 1.2 | Certain Interpretations | 20 |
| Article 2 PURCHASE, SALE AND ASSIGNMENT OF THE REVENUE INTEREST | 21 | |
| Section 2.1 | Purchase, Sale and Assignment | 21 |
| Section 2.2 | Purchase Price | 22 |
| Section 2.3 | Effect of Sale of Product Rights | 22 |
| Section 2.4 | Effect of Change of Control | 23 |
| Section 2.5 | Warrant | 23 |
| Section 2.6 | No Assumed Obligations, Etc. | 23 |
| Section 2.7 | Performance Rachet | 24 |
| Article 3 CLOSING AND PAYMENT OF PURCHASE PRICE | 24 | |
| Section 3.1 | Closing | 24 |
| Section 3.2 | Payment of Purchase Price | 24 |
| Section 3.3 | Seller Closing Deliverables | 25 |
| Section 3.4 | Buyer Closing Deliverables | 26 |
| Section 3.5 | Closing Conditions | 27 |
| Article 4 REPRESENTATIONS AND WARRANTIES OF THE SELLER | 28 | |
| Section 4.1 | Existence; Good Standing | 28 |
| Section 4.2 | Authorization | 28 |
| Section 4.3 | Enforceability | 28 |
| Section 4.4 | No Conflicts | 28 |
| Section 4.5 | Consents | 28 |
| Section 4.6 | No Litigation | 28 |
| Section 4.7 | Compliance | 29 |
| Section 4.8 | Licenses | 30 |
| Section 4.9 | No Liens; Title to Revenue Participation Right | 33 |
| Section 4.10 | Manufacturing; Supply | 33 |
| Section 4.11 | Intellectual Property | 33 |
| Section 4.12 | Indebtedness | 35 |
| Section 4.13 | Lien-Related Representation and Warranties | 35 |
| Section 4.14 | Brokers’ Fees | 35 |
| Section 4.15 | Preemptive Rights | 35 |
| Section 4.16 | Valid Issuance | 36 |
| Section 4.17 | SEC Filings | 36 |
| Section 4.18 | Compliance with Nasdaq Continued Listing Requirements | 36 |
| Section 4.19 | No Directed Selling Efforts or General Solicitation | 36 |
i
| Section 4.20 | No Integrated Offering | 36 |
|---|---|---|
| Section 4.21 | Private Placement | 36 |
| Section 4.22 | Investment Company | 36 |
| Section 4.23 | Shell Company Status | 37 |
| Article 5 REPRESENTATIONS AND WARRANTIES OF THE BUYER | 37 | |
| Section 5.1 | Existence; Good Standing | 37 |
| Section 5.2 | Authorization | 37 |
| Section 5.3 | Enforceability | 37 |
| Section 5.4 | No Conflicts | 37 |
| Section 5.5 | Consents | 37 |
| Section 5.6 | No Litigation | 37 |
| Section 5.7 | Financing | 37 |
| Article 6 COVENANTS | 38 | |
| Section 6.1 | Disclosures | 38 |
| Section 6.2 | Information Rights | 38 |
| Section 6.3 | Revenue Payments; Revenue Participation and Revenue Payment Details | 39 |
| Section 6.4 | Inspections and Audits of the Seller | 40 |
| Section 6.5 | Inspections and Audits of Licensee | 41 |
| Section 6.6 | Intellectual Property Matters | 41 |
| Section 6.7 | In-Licenses | 43 |
| Section 6.8 | Out-Licenses | 43 |
| Section 6.9 | Indebtedness | 46 |
| Section 6.10 | Liens | 46 |
| Section 6.11 | Negative Pledges | 46 |
| Section 6.12 | Dispositions. | 46 |
| Section 6.13 | Commercialization | 47 |
| Section 6.14 | Efforts to Consummate Transactions | 47 |
| Section 6.15 | Certain Tax Matters. | 47 |
| Section 6.16 | Further Assurances | 48 |
| Section 6.17 | Back-Up Security Interest | 48 |
| Section 6.18 | Event of Default | 49 |
| Article 7 INDEMNIFICATION | 49 | |
| Section 7.1 | General Indemnity | 49 |
| Section 7.2 | Claims Procedures | 50 |
| Section 7.3 | Limitations on Liability; Time for Claims | 51 |
| Section 7.4 | Tax Treatment of Indemnification Payments | 52 |
| Section 7.5 | Exclusive Remedy | 52 |
| Article 8 CONFIDENTIALITY | 52 | |
| Section 8.1 | Confidentiality | 52 |
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| Section 8.2 | Authorized Disclosure | 53 |
|---|---|---|
| Article 9 TERMINATION | 54 | |
| Section 9.1 | Mutual Termination | 54 |
| Section 9.2 | Termination Prior to Closing. | 54 |
| Section 9.3 | Automatic Termination | 54 |
| Section 9.4 | Effect of Termination | 55 |
| Section 9.5 | Survival | 55 |
| Article 10 SECURITY INTEREST | 55 | |
| Section 10.1 | Grant of Security Interest | 55 |
| Section 10.2 | Further Assurances | 55 |
| Section 10.3 | Remedies | 56 |
| Article 11 MISCELLANEOUS | 57 | |
| Section 11.1 | Headings | 57 |
| Section 11.2 | Notices | 57 |
| Section 11.3 | Expenses | 58 |
| Section 11.4 | Assignment | 58 |
| Section 11.5 | Amendment and Waiver | 58 |
| Section 11.6 | Entire Agreement | 59 |
| Section 11.7 | No Third Party Beneficiaries | 59 |
| Section 11.8 | Governing Law | 59 |
| Section 11.9 | Jurisdiction; Venue | 59 |
| Section 11.10 | Severability | 60 |
| Section 11.11 | Specific Performance | 60 |
| Section 11.12 | Counterparts | 60 |
| Section 11.13 | Relationship of the Parties | 60 |
| Section 11.14 | Intercreditor Agreement | 61 |
iii
Index of Schedules
| Schedule 1.1(a): | Knowledge Parties |
|---|---|
| Schedule 4.8(b): | Out-Licensing Amendments |
| Schedule 4.8(f): | Compliance, Breaches and Defaults |
| Schedule 4.11(a): | Existing Patent Rights |
| Schedule 4.11(b): | Existing Trademark Rights |
| Schedule 4.12: | Indebtedness |
Index of Exhibits
| Exhibit A: | Form of Warrant |
|---|---|
| Exhibit B: | Form of Bill of Sale |
| Exhibit C: | Buyer Account |
| Exhibit D: | Data Room Index |
| Exhibit E: | Form of Hercules Intercreditor Agreement |
| Exhibit F: | Form of Medtronic Intercreditor Agreement |
| Exhibit G: | Form of IP Security Agreement |
| Exhibit H: | Seller Account |
| Exhibit I: | Form of Solvency Certificate |
| Exhibit J: | Medtronic Agreement |
| Exhibit K: | Terumo Agreement |
| Exhibit L: | Press Release |
| Exhibit M | Hercules Loan Agreement Second Amendment |
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*** Certain information in this document has been excluded pursuant to Regulation S-K, item 601(b)(10). Such excluded information is not material and is information that the company treats as private or confidential. Such omitted information is indicated by brackets “[***]”) in this exhibit. ***
REVENUE PARTICIPATION RIGHT PURCHASE AND SALE AGREEMENT
This REVENUE PARTICIPATION RIGHT PURCHASE AND SALE AGREEMENT, dated as of July 31, 2025 (this “Agreement”), is made and entered into by and between Ligand Pharmaceuticals, Inc., a Delaware corporation (the “Buyer”), Orchestra BioMed Holdings, Inc., a Delaware corporation (the “Seller”) and, solely with respect to Article 10, Orchestra Biomed, Inc., BackBeat Medical, LLC and Caliber Therapeutics, LLC (together with Seller, each a “Pledgor” and collectively, the “Pledgors”).
W I T N E S S E T H:
WHEREAS, the Seller is in the business of, among other things, developing and commercializing the Products;
WHEREAS, the Buyer desires to purchase the Revenue Participation Right from the Seller in exchange for payment of the Purchase Price, and the Seller desires to sell the Revenue Participation Right to the Buyer in exchange for the Buyer’s payment of the Purchase Price, in each case on the terms and conditions set forth in this Agreement; and
WHEREAS, in consideration of Buyer’s purchase of the Revenue Participation Right and the Revenue Payments as described herein, the Seller shall issue the Warrant to the Buyer, on the terms and subject to the conditions set forth therein.
NOW THEREFORE, in consideration of the representations, warranties, covenants and agreements set forth herein and for good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Seller and the Buyer hereby agree as follows:
Article 1
DEFINITIONS
Section 1.1 Definitions. The following terms, as used herein, shall have the following meanings:
“Affiliate” means, with respect to any particular Person, any other Person directly or indirectly controlling, controlled by or under common control with such particular Person. For purposes of the foregoing sentence, the term “control” means direct or indirect ownership of: (a) ten percent (10%) or more, including ownership by trusts with substantially the same beneficial interests, of the voting and equity rights of such Person, firm, trust, corporation, partnership or other entity or combination thereof, or (b) the power to direct the management of such person, firm, trust, corporation, partnership or other entity or combination thereof, by contract or otherwise.
“Agreement” is defined in the preamble.
“Backbeat Clinical Study” means the clinical trial that has been initiated by BackBeat Medical, Inc., titled “Clinical Evaluation of Safety and Effectiveness of Azure+Backbeat CNT System in Subjects with Hypertension: A Double-Blind Randomized Trial.”
“Back-Up Security Interest” is defined in Section 2.1(b).
“Bankruptcy Laws” means, collectively, bankruptcy, insolvency, reorganization, moratorium, fraudulent conveyance, fraudulent transfer or other similar laws affecting the enforcement of creditors’ rights generally.
“Bill of Sale” means that certain bill of sale, dated as of the Closing Date, executed by the Seller and the Buyer, substantially in the form attached hereto as Exhibit B.
“Business Day” means any day other than (a) a Saturday or Sunday or (b) a day on which banking institutions located in New York, New York are permitted or required by applicable law or regulation to remain closed.
“Buyer” is defined in the preamble.
“Buyer Account” means the account set forth on Exhibit C hereto or such other account as may be designated by the Buyer in writing from time to time.
“Buyer Connection Tax” means any Tax to the extent that it would not be imposed but for (a) any connection of Buyer with the jurisdiction of the applicable taxing authority (other than a connection arising solely from this Agreement or any transaction contemplated hereby, but including a connection arising due to any change in domicile of Buyer or due to the domicile or change in domicile of an assignee of Buyer) or (b) any failure of Buyer to provide any applicable documentation that is reasonably requested by the applicable withholding agent and that Buyer is legally eligible to provide.
“Buyer Indemnified Representatives” is defined in Section 7.1(a).
“Calendar Quarter” means a period of three (3) consecutive months ending at midnight, New York City time on the last day of March, June, September, or December, respectively.
“Calendar Year” means a period of twelve (12) consecutive months commencing on January 1 of any year.
“Change of Control” means the occurrence of any of the following events: (i) an acquisition of the Seller by a Third Party by means of any transaction or series of related transactions (including, without limitation, any reorganization, merger or consolidation but excluding any merger effected exclusively for the purpose of changing the domicile of the Seller), or (ii) a sale of all of Seller (collectively, a “Merger”), so long as in either case the Seller’s stockholders of record immediately prior to such Merger will, immediately after such Merger, hold less than fifty percent (50%) of the voting power of the surviving or acquiring entity.
“Closing” means the closing of the sale, transfer, assignment and conveyance of the Revenue Participation Right hereunder.
“Closing Date” is defined in Section 3.1.
“Collateral” is defined in Section 10.1.
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“Commercialization” means any and all activities directed to the distribution, marketing, detailing, promotion selling and securing of reimbursement of the Products in the Territory (including the using, importing, selling and offering for sale of the Products), and shall include post-Marketing Approval studies to the extent required by a Regulatory Authority, post-launch marketing, promoting, detailing, distributing, selling the Products, importing, exporting or transporting the Products for sale, and regulatory compliance with respect to the foregoing. When used as a verb, “Commercialize” means to engage in Commercialization. Except with respect to post-Marketing Approval studies required by a Regulatory Authority, Commercialization shall not include any activities directed to the research or development (including pre-clinical and clinical development) or manufacture of the Products.
“Commercialization Partner” means (a) Medtronic (b) Terumo and (c) any other Licensee that holds rights to Commercialize any Product in all or any portion of the Territory.
“Commercially Reasonable Efforts” means the level of efforts and resources that are commonly used by a public company in the research-based medical device industry of similar stage, size and resources to Seller (provided that such stage, size and resources shall not materially decrease below the stage, size and resources of the Seller as of the Closing Date) to develop, manufacture or Commercialize, as the case may be, a comparable product for a comparable clinical indication (with respect to market size and commercial opportunity) at a similar stage in its development or product life and of a similar market and profit potential to the Products (but without regard to the Seller’s financial obligations under this Agreement), in each case, measured as of the time that such efforts and resources are required to be used under this Agreement.
“Confidential Information” is defined in Section 8.1.
“Confidentiality Agreement” means that certain Confidentiality Agreement, dated February 11, 2025, by and between the Seller and Buyer.
“Contract” means any agreement, contract, instrument, arrangement, modification, waiver or understanding.
“Counterparty Confidential Information” means, collectively, the Medtronic Confidential Information and the Terumo Confidential Information.
“Data Room” means, collectively, the virtual data room established by Seller as of 5:00 p.m. (Eastern time) two (2) Business Days prior to the date hereof and made available to Buyer via SmartRoom, the index for which is attached hereto as Exhibit D.
“Deposit Agreement” means the deposit account control agreement entered into by the Depositary Bank, Buyer and the Seller, which shall be in form and substance reasonably acceptable to Buyer and Seller, as amended, supplemented or otherwise modified from time to time and any replacements thereof.
“Depositary Bank” means such bank or other financial institution approved by Buyer and Seller, including any successor Depositary Bank approved by Buyer and Seller.
“Disclosing Party” is defined in Section 8.1.
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“Disclosure Schedule” means the Disclosure Schedule, dated as of the date hereof, delivered to the Buyer by the Seller concurrently with the execution of this Agreement.
“Disposition” means any transaction, or series of related transactions, pursuant to which any Person sells (including, without limitation, any sale leaseback transaction), assigns, transfers, leases, licenses (as licensor) or otherwise disposes of any property or assets (whether now owned or hereafter acquired) to any other Person, in each case, whether or not the consideration therefor consists of cash, securities or other assets owned by the acquiring Person. For purposes of clarification, “Disposition” shall include (a) the sale or other disposition for value of any contracts. (b) any disposition of property through a “plan of division” under the Delaware Limited Liability Company Act or any comparable transaction under any similar law, or (c) the early termination or modification of any contract resulting in the receipt by such Person of a cash payment or other consideration in exchange for such event (other than payments in the ordinary course for accrued and unpaid amounts due through the date of termination or modification).
“Distributor” means a Third Party that (a) purchases or has the option to purchase any Product in finished form from or at the direction of the Seller or any of its Affiliates, (b) has the right, option or obligation to distribute, market and sell the Products (with or without packaging rights) in one or more regions, and (c) does not otherwise make any royalty, milestone, profit share or other similar payment to the Seller or its Affiliate based on such Third Party’s sale of the Products. The term “packaging rights” in this definition will mean the right for the Distributor to package or have packaged Products supplied in unpackaged bulk form into individual ready-for-sale packs. For the purposes of this Agreement, neither Terumo nor its Affiliates shall be deemed to be a Distributor with respect to the Terumo Agreement.
“EMA” means the European Medicines Agency, or any successor agency thereto.
“Equity Commitment” means $5,000,000.
“Equity Purchase Agreement” means that certain Stock Purchase Agreement entered into between the Buyer and the Seller pursuant to which the Equity Commitment is paid to Seller concurrently with the Closing.
“Event of Default” means (a) the commencement of any Insolvency Proceeding of the Seller or any of its Affiliates, (b) a breach or default by the Seller or any of its Affiliates of any of its or their payment obligations under this Agreement or (c) any other breach or default by the Seller or any of its Affiliates under this Agreement to the extent that Seller or such Affiliate fails to cure such breach or default within thirty (30) days from the date Seller is notified by Buyer of such breach or default.
“Excluded Liabilities and Obligations” is defined in Section 2.2(b).
“Existing Patent Rights” is defined in Section 4.11(a).
“FDA” means the U.S. Food and Drug Administration, or any successor agency thereto.
“First Installment” means $20,000,000.
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“GAAP” means generally accepted accounting principles in the United States in effect from time to time.
“Governmental Entity” means any: (a) nation, principality, republic, state, commonwealth, province, territory, county, municipality, district or other jurisdiction of any nature; (b) federal, state, local, municipal, foreign or other government; (c) governmental authority of any nature (including any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, board, instrumentality, officer, official, representative, organization, unit, body or other entity and any court, arbitrator or other tribunal); or (d) individual, body or other entity exercising, or entitled to exercise, any executive, legislative, judicial, administrative, regulatory, police, military or taxing authority or power of any nature.
“Gross Sales” is defined in the definition of “Net Sales”.
“Hercules” means Hercules Capital, Inc.
“Hercules Intercreditor Agreement” means that certain intercreditor agreement, dated as of the Closing Date, executed by and among the Seller, Buyer, Hercules and Medtronic, in substantially the form attached hereto as Exhibit E.
“Hercules Loan Agreement” means that certain Loan and Security Agreement, dated as of November 6, 2024, by and among the Seller, Orchestra BioMed, Inc., Caliber Therapeutics, LLC, BackBeat Medical, LLC, Freehold Surgical, LLC, the lenders that are a party thereto and Hercules, as amended by that certain First Amendment to Loan Security Agreement, dated as of December 30, 2024, as further amended as of the Closing Date by that Hercules Loan Agreement Second Amendment, and as may be further amended, restated, amended and restated or otherwise modified from time to time, in each case, in accordance with the Hercules Intercreditor Agreement.
“Hercules Loan Agreement Second Amendment” means that certain Second Amendment to Loan and Security Agreement, dated as of the Closing Date, executed by and among the Seller, Orchestra BioMed, Inc., Caliber Therapeutics, LLC, BackBeat Medical, LLC, Freehold Surgical, LLC, Motus GI, LLC, Motus GI Medical Technologies LTD, the lenders that are a party thereto and Hercules, substantially the form attached hereto as Exhibit M.
“Improvements” means any material improvement, invention or discovery relating to the Products, including the formulation, or the method of manufacture of the Products.
“In-License” means any material license, settlement agreement or other material agreement or arrangement between the Seller or any of its Affiliates and any Third Party pursuant to which the Seller or any of its Affiliates obtains a license or a covenant not to sue or similar grant of rights to any Patents or other material intellectual property rights of such Third Party that is necessary for, or used in, the development, manufacture, use or Commercialization of a Product in the Territory. For the avoidance of doubt, the Parties agree that ordinary course, non-exclusive agreements, such as reagent agreements, software agreements and clinical trial agreements are not a “material license, settlement agreement or other material agreement or arrangement” for the purposes of this definition.
“Included Product Revenue” means (a) Net Sales and (b) Other Product Revenue.
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“Included Product Revenue Royalty Rate” means, for the purposes of Revenue Payments payable hereunder:
(a) subject to clause (c) below, seventeen percent (17%) of Included Product Revenue with respect to the Primary Product, regardless of the field of use to which the Included Product Revenue relates;
(b) subject to clause (c) below, seventeen percent (17%) of Included Product Revenue with respect to the Secondary Product, regardless of the field of use to which the Included Product Revenue relates; and
(c) for each Calendar Year, once Buyer has actually received the Included Product Revenue Threshold in aggregate Revenue Payments accrued for such Calendar Year with respect to the Primary Product and the Secondary Product in the aggregate pursuant to subclauses (a) and (b) above, four percent (4%) of the Included Product Revenue with respect to the Primary Product in respect of or related to the Primary Product Field and four percent (4%) of the Included Product Revenue with respect to the Secondary Product in the Secondary Product Field.
Notwithstanding the foregoing, if, as of the time that a given Revenue Payment is due and payable to Buyer hereunder, the First Installment, but not the Second Installment, has been paid to Seller pursuant to this Agreement, then, with respect to subclauses (a) and (b) of the definition of Included Product Revenue Royalty Rate, the applicable percentage will be nine and seventy-one hundredths percent (9.71%), and with respect to subclause (c) of the definition of Included Product Revenue Royalty Rate, the applicable percentage will be two and twenty-nine hundredths percent (2.29%); provided, however, that if the Performance Event has not been achieved prior to October 1, 2026, then the Included Product Revenue Royalty Rate will be as set forth in Section 2.7.
“Included Product Revenue Threshold” means $17,000,000, as adjusted pursuant to Section 2.3(a)(i).
“Indebtedness” means, with respect to any Person, without duplication, (a) all indebtedness of such Person for borrowed money; (b) all obligations of such Person for the deferred purchase price of property or services (other than trade payables or other accounts payable incurred in the ordinary course of such Person’s business and not outstanding for more than 120 days after the date such payable was created and any earn-out, purchase price adjustment or similar obligation until such obligation appears in the liabilities section of the balance sheet of such Person); (c) all obligations of such Person evidenced by bonds, debentures, notes or other similar instruments or upon which interest payments are customarily made; (d) all reimbursement, payment or other obligations and liabilities of such Person created or arising under any conditional sales or other title retention agreement with respect to property used and/or acquired by such Person, even though the rights and remedies of the lessor, seller and/or lender thereunder may be limited to repossession or sale of such property; (e) all obligations of such Person under any lease of (or other arrangement conveying the right to use) real or personal property by such Person as lessee that is required under GAAP to be capitalized on the balance sheet of such Person, and, for purposes hereof, the amount of any such obligation shall be the capitalized amount thereof determined in accordance with GAAP; (f) all obligations and liabilities, contingent or otherwise, of such Person, in respect of letters of credit, acceptances and similar facilities; (g) all obligations and liabilities, calculated in accordance with accepted practice, of such Person under any hedging agreements; (h) all monetary obligations under any receivables factoring, receivable sales or similar transactions and all monetary obligations under any synthetic lease, tax ownership/operating lease, off-balance sheet financing or similar financing; (i) all contingent obligations; (j) all indebtedness that may (or is allowed or required to) be converted into one or more types of equity interests; and (k) all obligations referred to in clauses (a) through (j) of this definition of another Person secured by (or for which the holder of such Indebtedness has an existing right, contingent or otherwise, to be secured by) a Lien upon property owned by such Person, even though such Person has not assumed or become liable for the payment of such Indebtedness; provided that Indebtedness shall not include (i) any contingent obligations incurred in connection with letters of credit, letters of guaranty or similar instruments obtained or created in the ordinary course of business to support obligations of such Person that do not otherwise constitute Indebtedness; or (ii) endorsements of checks, bills of exchange and other instruments for deposit or collection in the ordinary course of business. The Indebtedness of any Person shall include the Indebtedness of any partnership of or joint venture in which such Person is a general partner or a joint venturer.
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“Indemnified Representative” is defined in Section 7.2(a).
“Indemnified Tax” means any non-U.S. withholding Tax (other than a Buyer Connection Tax) withheld by Seller or any other applicable withholding agent in respect of any payment made by Seller to Buyer pursuant to this Agreement.
“Indemnifying Representative” is defined in Section 7.2(a).
“Insolvency Proceeding” means any proceeding commenced by or against any Person under any provision of any Bankruptcy Law.
“Intellectual Property Rights” means any and all of the following as they exist in the Territory in respect of the applicable Product at any time: (a) the Patent Rights, (b) the Know-How Rights, (c) the Trademark Rights, and (d) any and all other material intellectual property rights or proprietary rights, in each case of clauses (a)-(d), owned or in-licensed by the Seller or any of its Affiliates or under which the Seller or any of its Affiliates is or may become empowered to grant licenses, in each case of clauses (a)-(d), that are necessary or used in the development, manufacture, use, or Commercialization of the Products in the Territory.
“IP Security Agreement” is defined in Section 10.2(b).
“Judgment” means any judgment, order, writ, injunction, citation, award or decree of any nature.
“Know-How” means any and all proprietary and confidential information, know-how and trade secrets, including processes, formulae, models and techniques (including rights in algorithms, data, databases, data collections, and software).
“Know-How Rights” means any and all material Know-How owned or in-licensed by the Seller or any of its Affiliates or under which the Seller or any of its Affiliates is or may become empowered to grant licenses (including, for the avoidance of doubt, material Know-How related to Improvements), in each case, that are necessary or used in the development, manufacture, use, or Commercialization of the Products.
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“Knowledge of the Seller” means the actual knowledge of the individuals listed on Schedule 1.1(a) of the Disclosure Schedule.
“Licensee” means the counterparty under any Out-License, including Medtronic and Terumo.
“Lien” means any mortgage, lien, pledge, participation interest, charge, adverse claim, security interest, encumbrance or restriction of any kind, including any restriction on use, transfer or exercise of any other attribute of ownership of any kind.
“Lockbox Account” is defined in Section 6.3(c).
“Loss” means any and all Judgments, damages, losses, claims, costs, liabilities and expenses, including reasonable fees and out-of-pocket expenses of counsel.
“Marketing Approval” means, an approval by the FDA, a Marketing Authorization Application approved by the EMA under the centralized European procedure, or any corresponding non-U.S. or non-EMA application, registration or certification, as applicable, necessary to market a Product approved by the corresponding Regulatory Authority in the Territory, as applicable, including pricing and reimbursement approvals where required.
“Material Adverse Effect” means
(a) a material adverse effect on the timing, duration or amount of the Revenue Payments, except to the extent resulting from events, changes, facts, conditions, circumstances or occurrences (i) generally affecting the industry in which the Seller and its Affiliates operate, or (ii) arising out of an action required or permitted by this Agreement or any action taken (or omitted to be taken) with the written consent or at the written request of Buyer; or
(b) a material adverse effect on (i) the Products in the Territory, (ii) any of the Patent Rights, including the Seller’s rights in or to any such Patent Rights, (iii) any Regulatory Approval of the Products or the timing thereof (excluding timing of pricing and reimbursement approvals) in the Territory, (iv) the legality, validity or enforceability of any provision of this Agreement or any of the Transaction Documents, (v) the ability of the Seller to perform any of its obligations under this Agreement or any of the Transaction documents, (vi) the rights or remedies of the Buyer under this Agreement or any of the Transaction Documents (including Buyer’s rights in, to and under the Revenue Participation Rights or the Back-Up Security Interest) (in each case, to the extent not waived or otherwise consented to by Buyer pursuant to the terms of this Agreement), or (vii) the business, assets, properties, liabilities (actual or contingent), operations, or condition (financial or otherwise) of the Seller, individually, or the Seller and its Affiliates taken as a whole.
“Medtronic” means Medtronic Inc.
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“Medtronic Agreement” means that certain Exclusive License and Collaboration Agreement, dated as of June 30, 2022, by and among Medtronic, Seller and BackBeat Medical, LLC, as amended by Amendment No. 1 to the Exclusive License and Collaboration Agreement, dated as of July 31, 2025, and as may be further amended from time to time in accordance with this Agreement.
“Medtronic Agreement Correspondence” means copies of all of the following, in each case with respect to the Territory:
(a) minutes of, and other reports and materials distributed at, the meetings of the JSC (as defined in the Medtronic Agreement) and any other subcommittee or working group to the extent that such information would reasonably be expected to have a material effect on the timing, duration or amount of the Revenue Payments; provided that Seller may redact any Confidential Information (as defined in the Medtronic Agreement) of Medtronic to the extent such Confidential Information is not permitted to be disclosed to Buyer by Seller pursuant to the Medtronic Agreement; provided that, if any of the foregoing has been provided to Buyer in a redacted form in accordance with the foregoing, Seller shall, upon Buyer’s request, use commercially reasonable efforts to obtain approval from the applicable Licensee, to disclose (i) the redacted portions of such information to Buyer or (ii) a subset of the redacted portions of such information that Medtronic is willing to permit disclosure to Buyer of, and, in each case, such corresponding unredacted materials shall also be Medtronic Agreement Correspondence hereunder;
(b) Medtronic Quarterly Reports; and
(c) material communications between Medtronic and the Seller relating to the Medtronic Agreement, Net Sales of the Primary Product, the Patent Rights, or the Primary Product that would reasonably be expected (individually or in the aggregate) to have a Material Adverse Effect.
“Medtronic Confidential Information” means, collectively, (a) the terms and conditions of the Medtronic Agreement, (b) any and all Confidential Information (as defined in the Medtronic Agreement) disclosed by or on behalf of Medtronic under the Medtronic Agreement or any other agreement between Medtronic and the Seller, and (c) any and all other information that is otherwise disclosed by or on behalf of Medtronic to the Seller or the Buyer on a confidential basis.
“Medtronic Intercreditor Agreement” means that certain intercreditor agreement, to be entered into concurrently with the execution of and funding under the Medtronic Loan Agreement, by and among Seller, Buyer and Medtronic, in substantially the form attached hereto as Exhibit F.
“Medtronic Joint Background Patents” means the Joint Background Patents as defined in Section 11.1 of the Medtronic Agreement.
“Medtronic Joint Integration Patents” means the Joint Integration Patents as defined in Section 11.2(c) of the Medtronic Agreement.
“Medtronic Loan Agreement” means that certain loan agreement, accompany note and related security agreement to be entered into on or around the date hereof, by and between Medtronic and Seller, so long as Seller has provided Buyer with a reasonable opportunity to review and Buyer has provided its prior written consent to Seller with respect thereto.
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“Medtronic Quarterly Reports” means the Quarterly Reports as defined in Section 8.4 of the Medtronic Agreement.
“Nasdaq” means the Nasdaq Global Market.
“Net Sales” means, with respect to any Product (or any component thereof) and for any applicable period, the gross amount invoiced, billed or otherwise recorded for sales of such Product (or any component thereof) anywhere in the Territory, for that period by or on behalf of the Seller or its Affiliates, or any Distributor (each of the foregoing Persons, for purposes of this definition, shall be considered a “Related Party”) to a Third Party, including to any Licensee (“Gross Sales”) less the following amounts, to the extent actually incurred or accrued (in accordance with GAAP) by a Related Party and not reimbursed by such Third Party, provided, that any given amount may be taken as a permitted deduction only once:
(a) rebates, chargebacks, quantity, trade and similar discounts, credits and allowances and other price reductions granted, allowed, incurred or paid in so far as they are applied to sales of such Product;
(b) discounts (including cash, quantity, trade, governmental, and similar discounts), coupons, retroactive price reductions, charge back payments and rebates granted to managed care organizations or to federal, state and local governments, or to their agencies (including, but not limited to, payments made under the “Medicare Part D Coverage Gap Discount Program” and the “Annual Fee for Branded Pharmaceutical Manufacturers” specific to the Products), in each case, as applied to sales of the Products and actually given to customers;
(c) credits, adjustments, and allowances, including those granted on account of price adjustments, billing errors, and damage, and rejection, return or recall of such Product;
(d) customs duties, surcharges and other similar governmental charges incurred in connection with the exportation or importation of the Products to the extent included in the gross amount invoiced;
(e) freight, postage, shipping and other transportation charges and insurance costs incurred with respect to the shipment of such Product to customers, in each case if charged separately and invoiced to the customer;
(f) sales, use, value-added, excise, turnover, inventory and other similar Taxes (excluding income Taxes), in each case, that Seller allocates to sales of such Product in accordance with Seller’s standard policies and procedures consistently applied across such Product, as adjusted for rebates and refunds, imposed in connection with the sales of such Product to any Third Party, to the extent such Taxes are not paid by the Third Party;
(g) actual copayment waiver amounts uncollected or uncollectible debt amounts with respect to sales of such Product, provided that if the debt is thereafter paid, the corresponding amount shall be added to the Net Sales of the period during which it is paid;
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(h) documented out of pocket amounts directly relating to co-pay programs, bridging programs or other similar patient assistance programs which may be implemented from time to time by the Seller; and
(i) other similar or customary deductions taken in the ordinary course of business as permitted in calculating net sales or net revenue (as applicable) under GAAP or generally accepted accounting principles consistently applied.
For clarity, “Net Sales” will not include (a) sales or dispositions of such Product for charitable, promotional, pre-clinical, clinical, regulatory, compassionate use, named patient use or indigent or other similar programs, (b) such Products used as samples or (c) sales or dispositions between any of the Related Parties (unless a Related Party is the final end-user of such Product); provided that the first sale or disposition of a given unit of such Product to a non-Related Party will be included within “Net Sales”.
Notwithstanding the foregoing, with respect to sale of a unit of sirolimus sold separately as a component of a Secondary Product, “Net Sales” means Seller’s net income with respect to each such sale calculated in accordance with GAAP consistently applied.
With respect to sales of such Products invoiced in U.S. dollars, Net Sales shall be determined in U.S. dollars. With respect to sales of such Products invoiced in a currency other than U.S. dollars, Net Sales shall be determined by converting the currencies at which the sales are made into U.S. dollars, at rates of exchange determined in a manner consistent with the Seller’s or a Licensee’s, as applicable, method for calculating rates of exchange in the preparation of the Seller’s or such Licensee’s annual financial statements in accordance with GAAP consistently applied.
“New Arrangement” is defined in Section 6.8(g).
“Other Product Revenue” shall mean consideration in any form that the Seller or any of its Affiliates receives or is entitled to receive from a Licensee in consideration for or in connection with the grant of rights related to development or Commercialization of a Product in all or any portion of the Territory, such as under or in connection with an Out-License, including upfront or license issuance fees, license maintenance fee, milestone payments based on and in respect of any Product, such as applicable development or sales-based milestones, royalties and profit share payments (including any interest thereon with respect to late payments of any of the forgoing). Other Product Revenue specifically excludes the following (but in no event to the extent of running royalties):
(a) payments made by the Licensee as consideration for the issuance of equity or debt securities of, or other investment in, the Seller or its Affiliates;
(b) loans received by the Seller or its Affiliates, to the extent such loans are not forgiven;
(c) reimbursement for patent expenses at the Seller’s or its Affiliates’ reasonable out-of-pocket costs, solely to the extent such expenses are applicable to the Products;
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(d) reimbursement for Product (or any portion thereof) supplied to a Licensee, so long as the cost thereof constitutes Net Sales hereunder;
(e) reimbursement for Seller’s or its Affiliates’ expenses in connection with the research and development (including pre-clinical and clinical development) of a Product to the extent that such expenses are expressly allocated for research and development activities of such Product pursuant to the applicable Out-License; provided that, for the avoidance of doubt, this subclause (e) shall not limit Buyer’s entitlement of amounts pursuant to subclause (f) and (g) below;
(f) upfront or license issuance fees, license maintenance fees, and milestone payments based on pre-clinical or clinical events (e.g. Regulatory Submissions or commencement of clinical trials), in each case, under the Terumo Agreement, once Buyer has received Revenue Payments with respect to the foregoing and subclause (g) equal to the Purchase Price;
(g) proceeds (including damages awards) resulting from any enforcement of Seller’s rights under the Terumo Agreement in connection with the Terumo Dispute once Buyer has received Revenue Payments with respect to the foregoing and subclause (f) equal to the Purchase Price; provided that in no event will the foregoing exclude amounts recovered that are in lieu of payments that would otherwise be Net Sales or Other Product Revenue hereunder; and
(h) the proceeds of a Change of Control or Product Rights Sale.
If an Out-License involves the granting of Commercialization rights with respect to a Product and also grants rights with respect to any product that is not a Product, then “Other Product Revenue” shall be the amounts of the consideration attributable to the grant of rights with respect to the Product, as reasonably determined by the Parties in good faith. For the avoidance of doubt, Other Product Revenue shall be calculated without set-off or offset, and Other Product Revenue shall include payments made in lieu of any of the foregoing.
“Out-License” means each license or other agreement (or series of agreements) between the Seller or any of its Affiliates and any Third Party (other than Distributors) pursuant to which the Seller or any of its Affiliates (a) grants a license or sublicense under, or (b) sells, transfers or assigns (including by way of merger or consolidation), in each case, any Intellectual Property Right related to the development or Commercialization of a Product in the Territory. For the avoidance of doubt, “Out-License” shall include each of the Medtronic Agreement and the Terumo Agreement.
“Participation Start Date” means the July 31, 2025.
“Party” means the Seller or the Buyer, individually, and “Parties” means the Buyer and the Seller jointly.
“Patent Rights” means any and all material Patents owned or in-licensed by the Seller or any of its Affiliates or under which the Seller or any of its Affiliates is or may become empowered to grant licenses (including, for the avoidance of doubt, material Patents related to Improvements) that are necessary or used in the development, manufacture, use, or Commercialization of the Products in any country in the Territory.
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“Patents” means any and all patents and patent applications existing as of the date of this Agreement and all patent applications filed hereafter, including any continuation, continuation-in-part, division, provisional or any substitute applications, any patent issued with respect to any of the foregoing patent applications, any certificate, reissue, reexamination, renewal or patent term extension or adjustment (including any supplementary protection certificate) of any such patent or other governmental actions which extend any of the subject matter of a patent, and any substitution patent, confirmation patent or registration patent or patent of addition based on any such patent, and all foreign counterparts of any of the foregoing.
“Performance Event” means the randomization per the study protocol of the 500^th^ human subject in the Backbeat Clinical Study, pursuant to the applicable protocol for the Backbeat Clinical Study; provided that if the FDA accepts a reduction in sample size for assessment of primary endpoints of the Backbeat Clinical Study, the achievement of such reduced sample size will be deemed a Performance Event so long as the reduced sample size is reasonably likely to improve the timeline for Commercialization of the Primary Product.
“Permitted License” is defined in Section 6.8(a).
“Permitted License Correspondence” means, with respect to each Permitted License, copies of all of the following, in each case with respect to the Territory and the subject matter of such Permitted License:
(a) minutes of, and other reports and materials distributed at, the meetings of the joint steering committee and any other subcommittee or working group set forth in such Permitted License to the extent that such information would reasonably be expected to have a material effect on the timing, duration or amount of the Revenue Payments; provided that Seller may redact any of the Permitted License’s technical information prior to providing such information to Buyer;
(b) reports delivered to Seller by the counterparty of such Permitted License with respect to the amount invoiced, billed or otherwise recorded for sales of the products described in such Permitted License; and
(c) material communications between the counterparty and the Seller relating to such Permitted License, sales of the products described in such Permitted License, the Patent Rights, or the product described in such Permitted License that would reasonably be expected (individually or in the aggregate) to have a Material Adverse Effect.
“Permitted Liens” means the following:
(a) Liens created in favor of Hercules and the other lenders party to the Hercules Loan Agreement pursuant to the Hercules Loan Agreement and subject at all times to the Hercules Intercreditor Agreement;
(b) Liens securing Taxes, assessments and other governmental charges, the payment of which are not yet due and payable or is being contested in good faith by appropriate proceedings promptly initiated and diligently conducted and for which such reserve or other appropriate provisions, if any, as shall be required by GAAP shall have been made;
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(c) Liens imposed by any law arising in the ordinary course of business, including carriers’, warehousemen’s, landlords’, and mechanics’ liens, liens relating to leasehold improvements and other similar Liens arising in the ordinary course of business and which (x) do not in the aggregate materially detract from the value of the property subject thereto or materially impair the use thereof in the operations of the business of such Person or (y) are being contested in good faith by appropriate proceedings, which proceedings have the effect of preventing the forfeiture or sale of the property subject to such Liens and for which adequate reserves have been made if required in accordance with GAAP;
(d) rights of any counterparty pursuant to any Permitted Licenses, including any interest or title of a counterparty under a Permitted License;
(e) Liens created in favor of the Buyer pursuant to this Agreement, the IP Security Agreement and any other Transaction Document;
(f) pledges or deposits made in the ordinary course of business in connection with bids, contract leases, appeal bonds, workers’ compensation, unemployment insurance or other similar social security legislation;
(g) servitudes, easements, rights of way, restrictions and other similar encumbrances on real property imposed by any law and Liens consisting of zoning or building restrictions, easements, licenses, restrictions on the use of property or minor imperfections in title thereto which, individually and in the aggregate, are not material, and which do not in any case materially detract from the value of the property subject thereto or interfere with the ordinary conduct of the business of the Seller or any of its Subsidiaries;
(h) Liens in favor of customs and revenue authorities arising as a matter of law to secure payment of customs duties in connection with the importation of goods and incurred in the ordinary course of business;
(i) bankers’ liens, rights of setoff and similar Liens incurred on deposits made in the ordinary course of business;
(j) Liens arising from precautionary UCC financing statement filings regarding operating leases of personal property and consignment arrangements entered into in the ordinary course of business; and
(k) additional Liens so long as (i) such Liens do not secure debt for borrowed money, (ii) such Liens attach to specific assets (that are not Product Collateral), and not substantially all of the assets of the Seller and its Subsidiaries and (iii) the aggregate principal amount of the obligations secured thereby does not exceed $100,000 at any times outstanding.
“Person” means any individual, firm, corporation, company, partnership, limited liability company, trust, joint venture, association, estate, trust, Governmental Entity or other entity, enterprise, association or organization.
“Pledgor” is defined in the preamble.
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“Primary Product” means any and all atrioventricular interval modulation, including the product known as of the date hereof as BackBeat Cardiac Neuromodulation Therapy™, and any Improvement thereof or thereto. For the avoidance of doubt, the Primary Product includes any product that constitutes a Product (as defined in the Medtronic Agreement) under the Medtronic Agreement.
“Primary Product Field” means the field of hypertension treatment.
“Prime Rate” means the prime rate published by The Wall Street Journal, from time to time, as the prime rate.
“Product Collateral” means all of Seller’s or any of its Affiliates’ rights, title and interest in, to and under the following, whether now owned or hereafter acquired: (a) the Revenue Participation Right, (b) the Revenue Payments, (c) the Product Rights, (d) the Products, and (e) any “proceeds” (as defined in the UCC) of the foregoing.
“Product Rights” means any and all of the following, as they exist throughout the Territory as of the date hereof and during the term of this Agreement, in each case that are related to a Product: (a) Intellectual Property Rights, (b) Regulatory Submissions with respect to the Products, (c) In-Licenses, and (d) Out-Licenses.
“Product Rights Sale” is defined in Section 2.3(a)(i).
“Product Rights Sale Notice” is defined in Section 2.3(a)(i).
“Products” means any and all Primary Products and any and all Secondary Products.
“Proscribed Person” means a Person who:
(a) is, at the applicable time, a party to a dispute with the Seller pending before a Governmental Entity;
(b) has been or has an officer or director (that is, at the applicable time, employed by such Person) who has been: (i) debarred pursuant to subsections 306(a) or (b) of the Federal Food, Drug and Cosmetic Act, as amended (U.S.C. § 335(a) or (b)); (ii) suspended, debarred, or excluded from participating in any federal or state health care program; or (iii) convicted of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a) but has not yet been excluded; or
(c) is or has an officer or director (that is, at the applicable time, employed by such Person) who is subject to U.S. economic sanctions (e.g., placed on the Specially Designated Nationals and Blocked Persons List).
“Purchase Price” is defined in Section 2.2.
“Receiving Party” is defined in Section 8.1.
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“Regulatory Approval” means any and all approvals, licenses, registrations, or authorizations of Regulatory Submissions by Regulatory Authorities in the applicable regulatory jurisdiction, that are necessary for the manufacture, use, storage, import, transport or sale of a medical device product in such regulatory jurisdiction, or are agreed to be required for the Commercialization between the Parties, including Marketing Approval, and any approval for changes to the preceding approvals such as changes to indication or legal manufacturer.
“Regulatory Authority” means any national, supranational, regional, state or local regulatory agency, department, bureau, commission council or other governmental entity whose review or approval is legally required for the manufacture, packaging, use, storage, import, export, distribution or promotion of a medical device product in the applicable jurisdiction, including the FDA and the EMA.
“Regulatory Submissions” means all applications, approvals, licenses, notifications, registrations, submissions an authorizations made to a Regulatory Authority in connection with the development, manufacture or Commercialization of a medical device product, including any marketing and reimbursements.
“Related Party” is defined in the definition of “Net Sales”.
“Representative” means, with respect to any Person, the trustees, directors, members, partners, managers, officers, employees, agents, advisors or other representatives (including attorneys, accountants, consultants, and financial advisors) of such Person.
“Revenue Allocation Ratio” is defined in Section 2.3(a)(i).
“Revenue Participation Right” means the right to receive in full all of the Revenue Payments, and an undivided ownership interest in all accounts (as defined in the UCC), general intangibles (as defined in the UCC), payment intangibles (as defined in the UCC) and all other rights to payment on account of, in connection with or arising from all Net Sales occurring, and all Other Product Revenue received, on and after the Participation Start Date, and all proceeds thereof, in an amount equal to the Included Product Revenue Royalty Rate.
“Revenue Payment Term” means the period commencing on the Participation Start Date and ending on the date in which no Product is being developed or Commercialized by or on behalf of Seller, any of its Affiliates, or any of its or their Licensees or Distributors and Buyer has received the last Revenue Payment payable hereunder in connection therewith.
“Revenue Payments” means, for each Calendar Quarter occurring (in whole or in part) during the Revenue Payment Term, an amount payable to the Buyer equal to the product of the aggregate Included Product Revenue in respect of such Calendar Quarter, multiplied by the applicable Included Product Revenue Royalty Rate.
“Revenue Report” is defined in Section 6.3(b).
“Safety Notices” means any recalls, field notifications, market withdrawals, warnings, “dear doctor” letters, investigator notices, safety alerts or other notices of action issued or instigated by the Seller, any of its Affiliates or any Regulatory Authority, relating to an alleged lack of safety or regulatory compliance of any Product.
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“Second Installment” means $15,000,000.
“Second Installment Payment Date” is defined in Section 3.2(b).
“Secondary Product” means any and all sirolimus angioinfusion balloon products, including the product known as of the date hereof as Virtue^®^ Sirolimus AngioInfusion Balloon, and any Improvement thereof or thereto. For the avoidance of doubt, the Secondary Product includes any product that constitutes a Product (as defined in the Terumo Agreement) under the Terumo Agreement.
“Secondary Product Field” means the field of coronary artery treatment.
“Securities” is defined in Section 2.5.
“Seller” is defined in the preamble.
“Seller Account” means the account set forth on Exhibit H hereto or such other account as may be designated by the Seller in writing from time to time.
“Seller Common Stock” means the Common Stock, $0.0001 par value, of the Seller.
“Seller Indemnified Representatives” is defined in Section 7.1(b).
“Set-Off” means any right of set-off, counterclaim, reduction or deduction by contract or otherwise.
“Strategic Acquiror” means any Third Party engaged in the Commercialization of biomedical devices; provided, however, that Strategic Acquirer shall exclude any Third Party that does not directly Commercialize biomedical devices and is engaged in the business of buying or monetizing biopharmaceutical royalties.
“Strategic Transaction” means either (i) a Change of Control where the acquiror is a Strategic Acquiror, or (ii) a sale or transfer to a Strategic Acquiror of all or substantially all of the Product Rights related to a Product, whether by merger, sale of assets, reorganization, or other conveyance of title.
“Subsidiary” means any and all corporations, partnerships, limited liability companies, joint ventures, associations and other entities controlled (by contract or otherwise) by the Seller directly or indirectly through one or more intermediaries. For purposes hereof, the Seller shall be deemed to control a partnership, limited liability company, association or other business entity if the Seller, directly or indirectly through one or more intermediaries, shall be allocated a majority of partnership, limited liability company, association or other business entity gains or losses or shall be or control the managing director or general partner of such partnership, limited liability company, association or other business entity.
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“Tax” or “Taxes” means any federal, state, local or foreign income, gross receipts, license, payroll, employment, excise, severance, occupation, premium, windfall profits, environmental, customs duties, capital stock, franchise, profits, withholding, social security, unemployment, disability, real property, personal property, abandoned property, value added, alternative or add-on minimum, estimated or other tax of any kind whatsoever, including any interest, penalty or addition thereto, whether disputed or not.
“Territory” means worldwide.
“Terumo” means Terumo Medical Corporation.
“Terumo Agreement” means that certain Distribution Agreement, dated as of June 13, 2019, by and between Terumo and Seller, as amended by that certain Amendment to Distribution Agreement, dated as of June 30, 2020 by and between Terumo and Seller, as further amended by that certain Letter Agreement, dated as of June 20, 2022, by and between Terumo and Seller, and as may be further amended from time to time in accordance with this Agreement.
“Terumo Agreement Correspondence” mean copies of all of the following, in each case with respect to the Territory:
(a) minutes of, and other reports and materials distributed at, the meetings of the JSC (as defined in the Terumo Agreement) and any other subcommittee or working group to the extent that such information would reasonably be expected to have a material effect on the timing, duration or amount of the Revenue Payments; provided that Seller may redact any Confidential Information (as defined in the Terumo Agreement) of Terumo to the extent such Confidential Information is not permitted to be disclosed to Buyer by Seller pursuant to the Terumo Agreement; provided that, if any of the foregoing has been provided to Buyer in a redacted form in accordance with the foregoing, Seller shall, upon Buyer’s request, use commercially reasonable efforts to obtain approval from the applicable Licensee, to disclose (i) the redacted portions of such information to Buyer or (ii) a subset of the redacted portions of such information that Terumo is willing to permit disclosure to Buyer of, and, in each case, such corresponding unredacted materials shall also be Terumo Agreement Correspondence hereunder;
(b) Terumo Quarterly Reports; and
(b) material communications between Terumo and the Seller relating to the Terumo Agreement, Net Sales of the Secondary Product, the Patent Rights, or the Secondary Product that would reasonably be expected (individually or in the aggregate) to have a Material Adverse Effect.
“Terumo Confidential Information” means, collectively, (a) the terms and conditions of the Terumo Agreement, (b) any and all Confidential Information (as defined in the Terumo Agreement) disclosed by or on behalf of Terumo under the Terumo Agreement or any other agreement between Terumo and the Seller, and (c) any and all other information that is otherwise disclosed by or on behalf of Terumo to the Seller or the Buyer on a confidential basis.
“Terumo Dispute” means any action, proceeding, lawsuit, litigation, arbitration, mediation or other formal legal proceeding by or before any Governmental Entity, arbitrator or mediator arising out of the facts or circumstances set forth in the letter, dated as of January 14, 2025, delivered by the Seller to Terumo.
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“Terumo Foreground Patents” means the Patents covering the Foreground Information (as defined in the Terumo Agreement) that are owned by Terumo and licensed to the Seller pursuant to Section 12.1(d) of the Terumo Agreement.
“Terumo Joint Background Patents” means the Patents covering the Foreground Information (as defined in the Terumo Agreement) that are owned jointly by the Seller and Terumo pursuant to Section 12.1(c)(ii) of the Terumo Agreement.
“Terumo Quarterly Reports” means the Quarterly Reports as defined in Section 9.2 of the Terumo Agreement.
“Third Party” means any Person that is not the Seller or the Seller’s Affiliates or Buyer or the Buyer’s Affiliates.
“Third Party Claim” is defined in Section 7.2(a).
“Trademark” means any word, name, symbol, color, designation, or device, or any combination thereof, that functions as an identifier of the source or origin of goods or services, including any trademark, trade dress, brand mark, service mark, trade name, brand name, logo, business symbol or domain names, whether or not registered, including the goodwill associated with each of the foregoing.
“Trademark Rights” means any and all material Trademarks owned or in-licensed by the Seller or any of its Affiliates or under which the Seller or any of its Affiliates is or may become empowered to grant licenses (including, for the avoidance of doubt, material Trademarks related to Improvements) necessary or used in the development, manufacture, use, or Commercialization of the Products in the Territory.
“Transaction Documents” means this Agreement, the Bill of Sale, the Warrant, the Hercules Intercreditor Agreement, the Medtronic Intercreditor Agreement, the IP Security Agreement and any other security agreements, ancillary documents or agreements executed in connection with any of the foregoing.
“UCC” means the Uniform Commercial Code as in effect from time to time in the State of New York; provided, that, if, with respect to any financing statement or by reason of any provisions of applicable law, the perfection or the effect of perfection or non-perfection of the back-up security interest or any portion thereof granted pursuant to is governed by the Uniform Commercial Code as in effect in a jurisdiction of the United States other than the State of New York, then “UCC” means the Uniform Commercial Code as in effect from time to time in such other jurisdiction for purposes of the provisions of this Agreement and any financing statement relating to such perfection or effect of perfection or non-perfection.
“Warrant Shares” is defined in Section 2.5.
“Warrant” is defined in Section 2.5.
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Section 1.2 Certain Interpretations.
(a) Except where expressly stated otherwise in this Agreement, the following rules of interpretation apply to this Agreement:
(i) “either” and “or” are not exclusive and “include,” “includes” and “including” are not limiting and shall be deemed to be followed by the words “without limitation”;
(ii) “extent” in the phrase “to the extent” means the degree to which a subject or other thing extends, and such phrase does not mean simply “if”;
(iii) “hereof,” “hereto,” “herein” and “hereunder” and words of similar import when used in this Agreement refer to this Agreement as a whole and not to any particular provision of this Agreement;
(iv) references to a Person are also to its permitted successors and assigns;
(v) references to the term “or” will be interpreted in the inclusive sense commonly associated with the term “and/or”;
(vi) definitions are applicable to the singular as well as the plural forms of such terms;
(vii) references to an “Article”, “Section” or “Exhibit” refer to an Article or Section of, or an Exhibit to, this Agreement, and references to a “Schedule” refer to the corresponding part of the Disclosure Schedule;
(viii) references to “$” or otherwise to dollar amounts refer to the lawful currency of the United States; and
(ix) references to a law include any amendment or modification to such law and any rules and regulations issued thereunder, whether such amendment or modification is made, or issuance of such rules and regulations occurs, before or after the date of this Agreement.
(b) The Parties 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 no presumption or burden of proof shall arise favoring or disfavoring any Party by virtue of the authorship of any of the provisions of this Agreement.
(c) The Disclosure Schedule is qualified in its entirety by reference to specific provisions of the Agreement, and is not intended to constitute, and shall not be construed as constituting, representations or warranties. The disclosures in any section or paragraph of the Disclosure Schedule shall qualify only (i) the corresponding section or paragraph in Article 4 and (ii) other sections or paragraphs in Article 4 to which its relevance is reasonably apparent from a reading of such disclosure. The inclusion of any information in the Disclosure Schedule shall not be deemed to be an admission or acknowledgment, in and of itself, that such information is required by the terms hereof to be disclosed, is material, has had or would reasonably be expected to result in a Material Adverse Effect, or is outside the ordinary course of business.
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Article 2
PURCHASE, SALE AND ASSIGNMENT OF THE REVENUE INTEREST
Section 2.1 Purchase, Sale and Assignment.
(a) At the Closing and upon the terms and subject to the conditions of this Agreement, the Seller shall sell, transfer, assign and convey to the Buyer, and the Buyer shall purchase, acquire and accept from the Seller, the Revenue Participation Right and the Revenue Payments, free and clear of all Liens (except for Liens expressly permitted pursuant to clause (e) of the definition of “Permitted Liens”). Immediately upon the Closing pursuant to this Section 2.1, all of the Seller’s right, title and interest in and to the Revenue Participation Right shall terminate, and all such right, title and interest shall vest in the Buyer.
(b) It is the intention of the Parties that the sale, transfer, assignment and conveyance of the Revenue Participation Right contemplated by this Agreement be, and is, a true, complete, absolute and irrevocable sale, transfer, assignment and conveyance by the Seller to the Buyer of all of the Seller’s rights, title and interests in and to the Revenue Participation Right. Neither the Seller nor the Buyer intends the transactions contemplated by this Agreement to be, or for any purpose characterized or treated as, a loan from the Buyer to the Seller, a financing transaction or a borrowing. It is the intention of the Parties that the beneficial interest in and title to the Revenue Participation Right and any “proceeds” (as such term is defined in the UCC) thereof shall not be part of the Seller’s estate in the event of the filing of a petition by or against the Seller under any Bankruptcy Laws. The Seller hereby waives, to the maximum extent permitted by applicable law, any right to contest or otherwise assert that the sale contemplated by this Agreement does not constitute a true, complete, absolute and irrevocable sale, transfer, assignment and conveyance by the Seller to the Buyer of all of the Seller’s right, title and interest in and to the Revenue Participation Right under applicable laws, which waiver shall, to the maximum extent permitted by applicable laws, be enforceable against the Seller in any bankruptcy or insolvency proceeding relating to the Seller. Accordingly, the Seller shall treat the sale, transfer, assignment and conveyance of the Revenue Participation Right as a sale of an “account,” a “payment intangible” or “general intangible” (as appropriate) in accordance with the UCC, and the Seller hereby authorizes the Buyer and its authorized Representatives at any time to file one or more financing statements or any amendments to financing statements previously filed by the Buyer (and continuation statements with respect to such financing statements when applicable) naming the Seller as the seller and the Buyer as the buyer in respect of the Revenue Participation Right. Not in derogation of the foregoing statement of the intent of the Parties in this regard, and for the purposes of providing additional assurances to the Buyer, including in the event that, despite the intent of the Parties, the sale, transfer, assignment and conveyance contemplated hereby is hereafter held not to be a sale, pursuant to the terms of Article X, the Seller and its Affiliates has hereby unconditionally and irrevocably granted to the Buyer, a continuing security interest and Lien in, and a right to set-off against, any and all right, title and interest of the Seller in, to and under the Collateral (the “Back-Up Security Interest”). Notwithstanding anything to the contrary herein, upon the date that Buyer has actually received Revenue Payments [***], the Liens and Back-Up Security Interest in, to and under the Product Rights shall be automatically released without any further action necessary. In furtherance of the foregoing, the Buyer shall promptly file UCC-3 terminations and deliver to the Seller a lien release letter, in each case, releasing such Liens and Back-Up Security Interest, and execute and deliver to the Seller, at the Seller’s expense, all other documents that the Seller shall reasonably request to evidence such release.
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Section 2.2 Purchase Price. Upon the terms and subject to the conditions of this Agreement, the purchase price to be paid by the Buyer in full consideration to the Seller for the sale, transfer, assignment and conveyance of the Revenue Participation Right is $35,000,000 (the “Purchase Price”), of which:
(a) The First Installment shall be paid to Seller in accordance with Section 3.2; and
(b) The Second Installment shall be paid to Seller in accordance with Section 3.2(b).
Section 2.3 Effect of Sale of Product Rights.
(a) Mechanics of a Product Rights Sale:
(i) Seller will give Buyer reasonable notice of its intent to sell the Product Rights with respect to the Primary Product or the Secondary Product that is not a Change of Control (each a “Product Rights Sale” and such notice, a “Product Rights Sale Notice”). [***].
(ii) As a condition precedent to consummating any Product Rights Sale, (A) Seller shall be required to assign this Agreement in part to the Third Party acquiror in such Product Rights Sale, with such Third Party acquiror and Buyer to make such changes or amendments consistent with the intent of this agreement, (B) such Third Party acquiror shall be required to agree in writing with the Buyer to be bound by the obligations of the Seller contained in this Agreement with respect to the Product sold in such Product Rights Sale, and (C) Seller shall remain liable to Buyer for its obligations to the Buyer hereunder with respect to the Product not sold in such Product Rights Sale and, if any rights are retained by Seller with respect to the Product sold in such Product Rights Sale, then Seller shall remain liable to the Buyer hereunder with respect thereto as if such Product Rights Sale had not occurred.
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(b) From and after the closing date of a Product Rights Sale:
(i) With respect to the Primary Product, Included Product Revenue shall be limited to [***].
(ii) With respect to the Secondary Product, Included Product Revenue shall be limited to [***].
Section 2.4 Effect of Change of Control. In the event of a Change of Control of Seller, then from and after the closing date of such transaction, the Included Product Revenue shall be limited as if there was a Product Rights Sale of both the Primary Product and the Secondary Product; [***].
Section 2.5 Warrant. In consideration of Buyer’s purchase of the Revenue Participation Right and the Revenue Payments as described herein, Seller shall issue to Buyer at the Closing a warrant (the “Warrant”) to purchase from Seller up to 2,000,000 shares of Seller Common Stock (the “Warrant Shares” and, together with the Warrant, the “Securities) on the terms and conditions set forth in the Warrant. The Warrant shall be substantially in the form attached hereto as Exhibit A.
Section 2.6 No Assumed Obligations, Etc. Notwithstanding any provision in this Agreement to the contrary, the Buyer is only agreeing, on the terms and conditions set forth in this Agreement, to purchase, acquire and accept the Revenue Participation Right and is not assuming any liability or obligation of the Seller or its Affiliates of whatever nature, whether presently in existence or arising or asserted hereafter (including any liability or obligation of the Seller under the Medtronic Agreement or Terumo Agreement). All such liabilities and obligations shall be retained by and remain liabilities and obligations of the Seller or the Seller’s Affiliates, as the case may be (the “Excluded Liabilities and Obligations”).
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Section 2.7 Performance Rachet.
(a) If the Performance Event is not achieved by or on behalf of Seller (or any of its Affiliates or Licensees) prior to October 1, 2026, then beginning on such date, the percentages set forth in the definition of Included Product Royalty Rate will be, (i) with respect to subclauses (a) and (b) of such definition, eighteen percent (18%) and (ii) with respect to subclause (c) of such definition, five percent (5%).
(b) If the Performance Event is not achieved by or on behalf of Seller (or any of its Affiliates or Licensees) prior to November 16, 2026, then beginning on such date, the percentages set forth in the definition of Included Product Royalty Rate will be, (i) with respect to subclauses (a) and (b) of such definition, nineteen percent (19%) and (ii) with respect to subclause (c) of such definition, six percent (6%).
(c) If the Performance Event is not achieved by or on behalf of Seller (or any of its Affiliates or Licensees) prior to January 1, 2027, then beginning on such date, the percentages set forth in the definition of Included Product Royalty Rate will be, (i) with respect to subclauses (a) and (b) of such definition, twenty percent (20%) and (ii) with respect to subclause (c) of such definition, seven percent (7%).
Article 3
CLOSING AND PAYMENT OF PURCHASE PRICE
Section 3.1 Closing. Subject to the satisfaction or waiver of the conditions to Closing set forth in Section 3.5 (other than those that by their terms are to be satisfied at the Closing, but subject to the satisfaction or waiver of such conditions at the Closing), the Closing shall take place remotely via the exchange of documentation on the date upon which the satisfaction or waiver of all conditions set forth in Section 3.5 (other than those that by their terms are to be satisfied at the Closing, but subject to the satisfaction or waiver of such conditions at the Closing), or such other place, time and date as the Parties may mutually agree (the “Closing Date”).
Section 3.2 Payment of Purchase Price.
(a) At the Closing, the Buyer shall deliver to the Seller payment of the First Installment by wire transfer of immediately available funds to the Seller Account.
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(b) On the first Business Day that is two hundred and seventy (270) days from the Closing Date, (the “Second Installment Payment Date”), the Buyer shall deliver to the Seller payment of the Second Installment by wire transfer of immediately available funds to the Seller Account; provided that the obligation of the Buyer to make the payment of the Second Installment is subject to Seller delivering to Buyer at least two (2) Business Days prior to the Second Installment Payment Date, a certificate of the Seller, signed by an executive officer of the Seller, certifying that, as of the Second Installment Date:
(i) the Medtronic Agreement remains in full force and effect;
(ii) the enrollment of subjects in the Backbeat Clinical Study has not been suspended (unless such suspension has been lifted), placed on clinical hold, terminated or otherwise stopped for any reason other than if full enrollment of the required number of subjects has been achieved in accordance with the applicable protocol for the Backbeat Clinical Study
(iii) the Seller has not received (A) from Medtronic any notice of termination of, or any notice expressing any intention to terminate, the Medtronic Agreement (whether in whole or in part) or (B) from Medtronic or any Regulatory Authority any notice of termination or suspension of, or any notice expressing any intention to terminate or suspend, the Backbeat Clinical Study (whether in whole or in part);
(iv) since the date of this Agreement, there has not occurred any Material Adverse Effect; and
(v) since the date of this Agreement, there has not occurred any event of default (or equivalent term) under the Hercules Loan Agreement or any event of default (or equivalent term) under the Medtronic Loan Agreement.
If Seller does not timely provide the foregoing certification, Buyer may, at its discretion, fund the Second Installment by wire transfer of immediately available funds to the Seller Account.
As soon as practicable (but in any event no later than one (1) Business Day) after payment of the Second Installment, Seller shall deliver to Buyer a duly executed receipt for payment of the Second Installment
Section 3.3 Seller Closing Deliverables. At the Closing (or such other time as set forth below), Seller shall deliver to Buyer:
(a) a duly executed counterpart to the Bill of Sale, evidencing the sale, transfer, assignment and conveyance to the Buyer of the Revenue Participation Right;
(b) a certificate of an executive officer of the Seller, dated as of the Closing, certifying as to the (i) attached copies of the organizational documents of the Seller and resolutions of the governing body of the Seller authorizing and approving the execution, delivery and performance by the Seller of the Transaction Documents and the transactions contemplated thereby and (ii) the incumbency of the officer or officers of the Seller who have executed and delivered the Transaction Documents, including therein a signature specimen of each such officer or officers;
(c) a certificate of an executive officer of the Seller, dated as of the Closing, certifying that the conditions specified in Section 3.5(a)(i) and Section 3.5(a)(ii) are satisfied;
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(d) a solvency certificate executed by the chief financial officer, treasurer or other senior financial or accounting officer of the Seller substantially in the form attached hereto Exhibit I;
(e) a copy of a UCC3 filed by the Seller evidencing the release of the liens on the Revenue Participation Right and Revenue Payments held by Hercules;
(f) a valid, properly executed IRS Form W-9 certifying that the Seller is exempt from U.S. federal withholding tax and “backup” withholding tax, which may be delivered prior to the Closing;
(g) a customary legal opinion of Paul Hastings LLP, as corporate counsel to the Seller;
(h) the Hercules Intercreditor Agreement, duly executed by the Buyer, Medtronic and Hercules (and acknowledged by the Seller);
(i) the Hercules Loan Agreement Second Amendment, duly executed by the Seller, each applicable Subsidiary of the Seller, each lender party thereto and Hercules;
(j) the IP Security Agreement, duly executed by the Buyer, the Seller and each Pledgor;
(k) the Equity Purchase Agreement, duly executed by the Seller; and
(l) the Warrant, duly executed by the Seller.
(m) As soon as practicable (but in any event no later than one (1) Business Day after the Closing) Seller shall deliver to Buyer a duly executed receipt for payment of the First Installment.
Section 3.4 Buyer Closing Deliverables. At the Closing (or such other time as set forth below), Buyer shall deliver to Seller:
(a) a duly executed counterparty to the Bill of Sale, evidencing the sale, transfer, assignment and conveyance to the Buyer of the Revenue Participation Right;
(b) a certificate of an executive officer or authorized signatory of Buyer, dated as of the Closing, certifying as to the (i) the incumbency of the officer or officers of such Buyer who have executed and (iii) delivered the Transaction Documents, including therein a signature specimen of each such officer or officers;
(c) a certificate of an executive officer or authorized signatory of the Buyer, dated as of the Closing, certifying that the conditions specified in Section 3.5(b)(i) are satisfied;
(d) a valid, properly executed IRS Form W-9 certifying that the Buyer is exempt from U.S. federal withholding tax with respect to the Revenue Payments, which may be delivered prior to Closing;
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(e) the Hercules Intercreditor Agreement, duly executed by the Buyer; and
(f) the IP Security Agreement, duly executed by the Buyer; and
(g) the Equity Purchase Agreement, duly executed by the Buyer.
Section 3.5 Closing Conditions.
(a) Conditions to the Buyer’s Obligations. The obligation of the Buyer to consummate the transactions contemplated by this Agreement is subject to the satisfaction of each of the following conditions at or prior to the Closing, any of which may be waived in writing by the Buyer in its sole discretion:
(i) The representations and warranties of the Seller contained in this Agreement shall be true and correct in all respects on and as of the Closing Date with the same effect as if made on and as of the Closing Date (other than such representations and warranties that are made as of a specified date, which representations and warranties shall be true and correct as of such date).
(ii) Since the date of this Agreement, there has not occurred any Material Adverse Effect.
(iii) The Buyer shall have received from Seller the closing deliverables as set forth in Section 3.3.
(iv) The closing of the transactions contemplated by the Equity Purchase Agreement shall have occurred.
(b) Conditions to the Seller’s Obligations. The obligation of the Seller to consummate the transactions contemplated by this Agreement is subject to the satisfaction of each of the following conditions at or prior to the Closing, any of which may be waived in writing by the Seller in its sole discretion:
(i) The representations and warranties of the Buyer contained in this Agreement shall be true and correct on and as of the Closing Date with the same effect as if made on and as of the Closing Date (other than such representations and warranties that are made as of a specified date, which representations and warranties shall be true and correct as of such date).
(ii) The Seller shall have received from Buyer the closing deliverables as set forth in Section 3.4.
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Article 4
REPRESENTATIONS AND WARRANTIES OF THE SELLER
Except as set forth on the Disclosure Schedule attached hereto, the Seller represents and warrants to the Buyer that as of the date hereof:
Section 4.1 Existence; Good Standing. The Seller is a corporation duly incorporated, validly existing and in good standing under the laws of the State of Delaware. The Seller is duly licensed or qualified to do business and is in corporate good standing in each jurisdiction in which the nature of the business conducted by it or the character or location of the properties and assets owned, leased or operated by it makes such licensing or qualification necessary.
Section 4.2 Authorization. The Seller has all requisite corporate power and authority to execute, deliver and perform its obligations under this Agreement. The execution, delivery and performance of this Agreement, and the consummation of the transactions contemplated hereby, have been duly authorized by all necessary corporate action on the part of the Seller. The Seller has the requisite corporate power and authority and has taken all requisite corporate action necessary for, and no further action on the part of the Seller, its officers, directors and stockholders is necessary for, the authorization, issuance (or reservation for issuance) and delivery of the Securities.
Section 4.3 Enforceability. This Agreement has been duly executed and delivered by an authorized officer of the Seller and constitutes the valid and binding obligation of the Seller, enforceable against the Seller in accordance with its terms, except as may be limited by applicable Bankruptcy Laws or by general principles of equity (whether considered in a proceeding in equity or at law).
Section 4.4 No Conflicts. The execution, delivery and performance by the Seller of this Agreement and the consummation of the transactions contemplated hereby do not and will not (a) contravene or conflict with the articles of, certificate of incorporation or bylaws of the Seller, (b) contravene or conflict with or constitute a material default under any law binding upon or applicable to the Seller or the Revenue Participation Right, (c) contravene or conflict with or constitute a material default under any material Contract or Judgment binding upon or applicable to the Seller or the Revenue Participation Right, or (d) contravene or conflict with or constitute a default under (i) the Medtronic Agreement, (ii) the Terumo Agreement, or (iii) except to the extent that such contravention, conflict, or breach would not reasonably be expected to result in a Material Adverse Effect, any other Contract binding upon or applicable to the Seller or any of its Affiliates.
Section 4.5 Consents. Except for the consents that have been obtained on or prior to the Closing, the UCC financing statements contemplated hereby, or any filings required by the federal securities laws or stock exchange rules, no consent, approval, license, order, authorization, registration, declaration or filing with or of any Governmental Entity or other Person is required to be done or obtained by the Seller in connection with (a) the execution and delivery by the Seller of this Agreement, (b) the performance by the Seller of its obligations under this Agreement or (c) the consummation by the Seller of any of the transactions contemplated by this Agreement.
Section 4.6 No Litigation. Neither the Seller nor any of its Affiliates is a party to, and has not received any written notice of, any action, suit, investigation or proceeding pending before any Governmental Entity and, to the Knowledge of the Seller, no such action, suit, investigation or proceeding has been threatened against the Seller, that, individually or in the aggregate, has had or would, if determined adversely, reasonably be expected to have a Material Adverse Effect.
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Section 4.7 Compliance.
(a) All applications, submissions, information and data related to the Products (other than projections or forward-looking information) submitted or utilized as the basis for any request to any Regulatory Authority by or on behalf of the Seller, its Affiliates, or, to the Knowledge of the Seller, its Licensees, were true and correct in all material respects as of the date of such submission or request. To the Knowledge of the Seller, any material updates, changes, corrections or modification to such applications, submissions, information or data required under applicable laws or regulations to be made by or on behalf of the Seller or its Licensees have been submitted to the necessary Regulatory Authorities.
(b) Neither the Seller nor its Affiliates or, to the Knowledge of the Seller, its Licensees, has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or EMA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” (“FDA Application Integrity Policy”), or any similar policies by the FDA or any other Governmental Entity, set forth in any applicable laws or regulations. Neither the Seller nor its Affiliates, or, to the Knowledge of the Seller, any of its and their respective officers, employees, contractors or agents is the subject of any pending or, to the Knowledge of the Seller, threatened investigation by the FDA that could reasonably result in the invocation of the FDA Application Integrity Policy or any similar policies by FDA or any other Governmental Entity.
(c) The Seller has provided to the Buyer prior to the date hereof in the Data Room true and correct copies or summaries of all material written communications sent or received by the Seller and any of its Affiliates to or from any Regulatory Authorities in the Territory that relate to the Products since January 1, 2021.
(d) None of the Seller, any of its Affiliates and, to the Knowledge of the Seller, its Licensees or any Third Party manufacturer of any Product, has received from the FDA a “Warning Letter”, Form FDA-483, “Untitled Letter,” or similar material written correspondence or notice alleging violations of applicable laws and regulations enforced by the FDA, or any comparable material written correspondence from any other Regulatory Authority in the Territory, with regard to any Product or the manufacture, processing, packaging or holding thereof, the subject of which communication is unresolved and if determined adversely to the Seller or such Affiliate, Licensee, or Third Party manufacturer, would, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect.
(e) Since January 1, 2021, (i) there have been no Safety Notices in the Territory, (ii) to the Knowledge of the Seller, there are no unresolved material product complaints with respect to the Products, which would result in a Material Adverse Effect, and (iii) to the Knowledge of the Seller, there are no facts currently in existence that would, individually or in the aggregate, reasonably be expected to result in (A) a material Safety Notice with respect to the Products, or (B) a material change in the labeling of the Products. Since January 1, 2021, neither the Seller nor any of its Affiliates nor, to the Knowledge of the Seller, its Licensees, has experienced any significant failures in the manufacturing of the Products for clinical use or commercial sale in the Territory that, individually or in the aggregate, have had or would reasonably be expected to result in, if such failure occurred again, a Material Adverse Effect.
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(f) The Seller, its Affiliates and, to the Knowledge of the Seller, its Licensees, possess all material permits, licenses, registrations, certificates, authorizations, orders and approvals from FDA or any similar Regulatory Authority necessary to conduct their business as currently conducted with respect to the Product (collectively, “Permits”). None of the Seller or any of its Affiliates or, to the Knowledge of the Seller, its Licensees have received any written notice of proceedings relating to the suspension, modification, revocation or cancellation of any Permit. Neither the Seller, its Affiliates, nor, to the Knowledge of the Seller, any Licensee, officer, employee or agent of the Seller or its Affiliates or Licensees has been convicted of any crime or engaged in any conduct that has previously caused or would reasonably be expected to result in (i) disqualification or debarment by the FDA under 21 U.S.C. Sections 335(a) or (b), or any similar law, rule or regulation of any other Governmental Entities, (ii) debarment, suspension, or exclusion under any federal healthcare programs or by the General Services Administration or under any similar program or by any Governmental Entities, or (iii) exclusion under 42 U.S.C. Section 1320a-7 or any similar law, rule or regulation of any other Governmental Entities. Neither the Seller, its Affiliates, nor, to the Knowledge of the Seller, any Licensee, officer, employee, contractor or agent of the Seller or its Affiliates or Licensees has made an untrue statement of material fact on, or material omissions from, any notifications, applications, approvals, reports and other submissions to the FDA or any other similar Regulatory Authority.
(g) The Seller, its Affiliates and, to the Knowledge of the Seller, its Licensees is and has been in compliance with all applicable laws administered or issued by the FDA or any similar Regulatory Authority, including the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, applicable requirements in FDA regulations, and any orders issued by FDA or any similar Regulatory Authorities, and all other laws regarding ownership, developing, testing, manufacturing, packaging, storage, import, export, disposal, marketing, distributing, promoting, and complaint handling or adverse event reporting for the products of the Seller, except to the extent that such failure to comply with such applicable laws would not reasonably be expected to result in a Material Adverse Effect.
Section 4.8 Licenses.
(a) In-Licenses. There are no In-Licenses currently in effect or contemplated.
(b) Out-Licenses. Attached hereto as Exhibit J, is true, correct and complete copy of the Medtronic Agreement. Attached hereto as Exhibit K, is true, correct and complete copy of the Terumo Agreement. The Seller has delivered to the Buyer true, correct and complete copies of all Medtronic Agreement Correspondence and Terumo Agreement Correspondence. Except for the Medtronic Agreement and the Terumo Agreement, there are no Out-Licenses. Other than the Medtronic Agreement, there are no Contracts between Seller (or any predecessor or Affiliate thereof), on the one hand, and Medtronic (or any predecessor or Affiliate), on the other hand, relating to any of the Products. Other than the Terumo Agreement, there are no Contracts between Seller (or any predecessor or Affiliate thereof), on the one hand, and Terumo (or any predecessor or Affiliate), on the other hand, relating to any of the Products. Neither the Seller nor Medtronic has made or entered into any amendment, supplement or modification to, or granted any waiver under any provision of the Medtronic Agreement. Neither the Seller nor Terumo has made or entered into any amendment, supplement or modification to, or granted any waiver under any provision of the Terumo Agreement. There is no proposal made by or to the Seller or its Affiliates to amend or waive any provision of the Medtronic Agreement or the Terumo Agreement in any manner that (i) would result in a breach of this Agreement or (ii) would otherwise reasonably be expected to have a Material Adverse Effect.
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(c) No Other Agreements. Other than the Medtronic Agreement and the Terumo Agreement, there are no other material Contracts between the Seller (or any predecessor or any Affiliate thereof), on the one hand, and any other Person, including Medtronic or Terumo (or any predecessor or Affiliate thereof), on the other hand, that relate to the Medtronic Agreement, the Terumo Agreement, any Patent Rights, the Products (including the research, development or Commercialization thereof), or the Revenue Payments. To the Knowledge of the Seller, the Medtronic Agreement is the only material Contract between Medtronic (or any predecessor or Affiliate thereof), on the one hand, and any other Person, on the other hand, relating to the Primary Product (including the research, development or Commercialization thereof), other than any Contracts entered into in the ordinary course with Distributors or contract manufacturing organizations (provided they are solely engaged in manufacturing) and other non-sales force service contractors (provided they are not engaged in any material Commercialization activities). To the Knowledge of the Seller, the Terumo Agreement is the only material Contract between Terumo (or any predecessor or Affiliate thereof), on the one hand, and any other Person, on the other hand, relating to the Secondary Product (including the research, development or Commercialization thereof), other than any Contracts entered into in the ordinary course with Distributors or contract manufacturing organizations (provided they are solely engaged in manufacturing) and other non-sales force service contractors (provided they are not engaged in any material Commercialization activities). No executed, draft or proposed Contract between the Seller (or any predecessor or any Affiliate thereof), on the one hand, and any other Person, including Medtronic or Terumo (or any predecessor or Affiliate thereof), on the other hand, contains any provision, term or condition that would reasonably be expected to result in a Material Adverse Effect.
(d) Validity and Enforceability of Licenses. Each of the Medtronic Agreement and the Terumo Agreement is a valid and binding obligation of the Seller and the respective counterparty thereto. Each of the Medtronic Agreement and the Terumo Agreement is enforceable against each respective counterparty thereto in accordance with its terms except as may be limited by applicable Bankruptcy Laws or by general principles of equity (whether considered in a proceeding in equity or at law). The Seller has not received any written notice in connection with the Medtronic Agreement or the Terumo Agreement challenging the validity or enforceability of any provision of such agreement.
(e) No Termination. Other than as disclosed on Schedule 4.8(f), the Seller has not (i) given notice to a counterparty of the termination of the Medtronic Agreement or the Terumo Agreement (whether in whole or in part) or any notice to a counterparty expressing any intention to terminate the Medtronic Agreement or Terumo Agreement or (ii) received from a counterparty thereto any written notice of termination of the Medtronic Agreement or Terumo Agreement (whether in whole or in part) or any written notice from a counterparty expressing any intention to terminate the Medtronic Agreement or Terumo Agreement. To the Knowledge of the Seller, no event has occurred that would give rise to the expiration or termination of, or either the Seller or a counterparty thereto having the right to terminate (other than contractual rights to terminate for convenience), the Medtronic Agreement or the Terumo Agreement.
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(f) Compliance; No Breaches or Defaults. Other than as disclosed on Schedule 4.8(f), (i) each of the Seller and Medtronic have complied with their respective obligations under the Medtronic Agreement in all material respects and (ii) each of the Seller and Terumo have complied with their respective obligations under the Terumo Agreement in all material respects. There is and has been no material breach or default under any provision of the Medtronic Agreement or Terumo Agreement either by the Seller or, to the Knowledge of the Seller, by the respective counterparty (or any predecessor thereof) thereto, and there is no event that upon notice or the passage of time, or both, would reasonably be expected to give rise to any breach or default either by the Seller or, to the Knowledge of the Seller, by the respective counterparty to such agreement.
(g) Payments Made. Medtronic has made all payments to the Seller required under the Medtronic Agreement as of the date hereof. Terumo has made all payments to the Seller required under the Terumo Agreement as of the date hereof. To the Knowledge of the Seller, other than the payments payable to the Seller under the Medtronic Agreement and Terumo Agreement, no Person is owed any royalty payment, milestone payment or other payment of any kind in connection with the discovery, research, development, manufacture, use, sale or other exploitation of any of the Products.
(h) No Assignments. The Seller has not consented to any assignment by the counterparty to the Medtronic Agreement or the Terumo Agreement of any of its rights or obligations under any Contracts and, to the Knowledge of the Seller, the counterparty has not assigned any of its rights or obligations under any such Contract to any Person. The Seller has not conveyed, assigned or in any other way transferred all or any portion of its right, title and interest in and to the Revenue Participation Right, the Revenue Payments, any Patent Rights, the Medtronic Agreement, or the Terumo Agreement, except for the Seller’s grant of a security interest to Hercules pursuant to that Hercules Loan Agreement.
(i) No Indemnification Claims. The Seller has not notified any Person of any claims for indemnification under any Out-License nor has the Seller received any claims for indemnification under any Out-License.
(j) No Infringement. Neither the Seller nor any of its Affiliates has received any written notice from, or given any written notice to, any counterparty to the Medtronic Agreement or Terumo Agreement regarding any infringement of any of the Existing Patent Rights.
(k) Product. The Primary Product is a “Product” under the Medtronic Agreement, and to the Knowledge of the Seller, there are no other products being researched, developed or Commercialized in the Territory by or on behalf of Medtronic under the Medtronic Agreement. The Secondary Product is a “Product” under the Terumo Agreement, and to the Knowledge of the Seller, there are no other products being researched, developed or Commercialized in the Territory by or on behalf of Terumo under the Terumo Agreement.
(l) Audits. The Seller has not initiated any inspection or audit of books of accounts or other records pertaining to Net Sales of a Product or the calculation of revenue share, royalties, milestone payments or other amounts payable to the Seller or any of its Affiliates or Subsidiaries under the Medtronic Agreement or the Terumo Agreement.
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(m) Transaction Classification. Neither the transactions contemplated under this Agreement, nor the exercise by Buyer of its rights under the Transaction Documents, constitute (i) Primary Field Prohibited Activities or Transactions (as defined in the Medtronic Agreement) or (ii) a Virtue Transaction (as defined in the Terumo Agreement).
Section 4.9 No Liens; Title to Revenue Participation Right. On the Closing, subject to receipt of the First Installment by Seller in accordance with Section 3.2, the Buyer will have acquired, subject to the terms and conditions set forth herein, good and marketable title to the Revenue Participation Right, the Revenue Payments and all “proceeds” (as defined in the UCC) of each of the foregoing, in each case free and clear of all Liens (except for Liens expressly permitted pursuant to clause (e) of the definition of “Permitted Liens”). None of the Product Rights or Products is subject to, or encumbered by, any Lien (except for Liens expressly permitted pursuant to clauses (a) and (e) of the definition of “Permitted Liens”). The Buyer has a Lien in the Product Rights and the Product that is superior to any Lien of any other Person other than any Lien expressly permitted by clause (a) of the definition of “Permitted Liens” and solely to the extent contemplated by and subject to the Hercules Intercreditor Agreement and the IP Security Agreement. The Seller holds all rights, interests, and title in the Product Collateral and has all authority and received all consents necessary to fully grant the Back-Up Security Interest.
Section 4.10 Manufacturing; Supply. The Products have, since January 1, 2021, been manufactured, transported, stored and handled in all material respects in accordance with applicable law and with good manufacturing practices in the Territory. Since January 1, 2021, neither the Seller nor any Affiliate of the Seller, nor, to the Knowledge of the Seller, any of its Licensees, has experienced any significant failures in the manufacturing or supply of any Product in the Territory that, individually or in the aggregate, have had or would reasonably be expected to result in, if such failure occurred again, a Material Adverse Effect. The Seller or, to the Knowledge of the Seller, Medtronic has on hand or has made adequate provisions to (a) secure sufficient clinical quantities of the Primary Product to complete all clinical trials and all activities required for Regulatory Approvals, in each case, that are ongoing or planned as of the date hereof in accordance with the Medtronic Agreement, and (b) secure sufficient quantities of the Primary Product to support the commercial launch of the Primary Products in the Primary Territories (as defined in the Medtronic Agreement). The Seller or, to the Knowledge of the Seller, Terumo has on hand or has made adequate provisions to (a) secure sufficient clinical quantities of the Secondary Product to complete all clinical trials and all activities required for Regulatory Approvals, in each case, that are ongoing or planned as of the date hereof in accordance with the Terumo Agreement, and (b) secure sufficient quantities of the Secondary Products to support the commercial launch of the Secondary Products in the Primary Territories (as defined in the Terumo Agreement).
Section 4.11 Intellectual Property.
(a) Schedule 4.11(a) of the Disclosure Schedule lists all of the currently existing Patents included within the Patent Rights (the “Existing Patent Rights”). Except as indicated on Schedule 4.11(a), the Seller or its Affiliates are the sole and exclusive owner of all Existing Patent Rights. To the Knowledge of the Seller, (i) Terumo is the sole and exclusive owner of all the currently existing Terumo Foreground Patents included within the Existing Patent Rights (the “Existing Terumo Patent Rights”), (ii) the Seller and Terumo are the only joint owners of and have a joint interest in all of currently existing Terumo Joint Background Patents included within the Existing Patent Rights, and (iii) the Seller and Medtronic are the only joint owners of and have a joint interest in all of currently existing Medtronic Joint Background Patents and Medtronic Joint Integration Patents included within the Existing Patent Rights. Schedule 4.11(a) of the Disclosure Schedule specifies as to each listed patent or patent application the assignee(s), the respective patent or application numbers, and the issue and filing dates.
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(b) Schedule 4.11(b) of the Disclosure Schedule lists all of the currently existing Trademarks owned by Seller or its Affiliates included within the Trademark Rights (together with any exclusively in-licensed Trademarks within the Trademark Rights, the “Existing Trademark Rights”). Except as set forth on Schedule 4.11(b) of the Disclosure Schedule, as of the date hereof, the Seller is the sole and exclusive owner of all of the Existing Trademark Rights.
(c) Neither the Seller nor any of its Affiliates is a party to any pending and, to the Knowledge of the Seller, there is no other pending or threatened, litigation, interference, reexamination, inter partes review, opposition or like procedure involving any of the Existing Patent Rights.
(d) All of the issued Patents within the Existing Patent Rights are (i) to the Knowledge of the Seller, valid, enforceable and (ii) in full force and effect. None of the issued Patents within the Existing Patent Rights have lapsed, expired or otherwise terminated. The Seller and its Affiliates, and to the Knowledge of the Seller, Medtronic, Terumo and their respective Affiliates, have not received (A) any written notice relating to the lapse, expiration or other termination of any of the issued Patents within the Existing Patent Rights, and (B) any opinion (however qualified) of outside counsel that alleges that, an issued Patent within any of the Existing Patent Rights, or patent claims therein, is invalid or unenforceable.
(e) To the Knowledge of the Seller, (i) each Person associated with the filing and prosecution of the Existing Patent Rights has complied in all material respects with all applicable duties of candor and good faith in dealing with their respective patent offices and (ii) each of the Existing Patent Rights correctly names each inventor of the claims thereof as determined in accordance with the laws of the jurisdiction in which such Existing Patent Right was issued or is pending.
(f) The Seller and its Affiliates, and to the Knowledge of the Seller, Medtronic, Terumo and their respective Affiliates, have not received any written notice that there is any, and, to the Knowledge of the Seller, there is no, Person who is or claims to be an inventor under any of the Existing Patent Rights who is not a named inventor thereof.
(g) Neither Seller nor its Affiliates has received any written notice of any claim by any Person challenging the inventorship or ownership of, the rights of the Seller in and to, or the patentability, validity or enforceability of, any of the Seller-owned Existing Patent Rights. To the Knowledge of the Seller, Terumo and its Affiliates, have not received any written notice of any claim by any Person challenging the inventorship or ownership of, the rights of Terumo in and to, or the patentability, validity or enforceability of any of the Existing Terumo Patent Rights. The Seller and its Affiliates and, to the Knowledge of the Seller, Medtronic, Terumo and their respective Affiliates, have not received any claim by any Person asserting that the development, manufacture, importation, sale, offer for sale or use of the Products infringes, misappropriates or otherwise violates or will infringe, misappropriate or otherwise violate such Person’s Patents or other intellectual property rights in the Territory.
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(h) To the Knowledge of the Seller, the discovery, development, manufacture, importation, sale, offer for sale or use of the Products, in each case in the form the Products exists as of the date hereof and as such activity is currently contemplated by the Seller, Medtronic or Terumo, as applicable, has not and will not, infringe, misappropriate or otherwise violate any Patents or other intellectual property rights owned by any Third Party in the Territory. To the Knowledge of the Seller, no Licensee has in-licensed any Patents or other intellectual property rights necessary to the discovery, development, manufacture, use, sale, offer for sale or import of the Product.
(i) To the Knowledge of the Seller, no Person has infringed, misappropriated or otherwise violated, or is infringing, misappropriating or otherwise violating, any of the Intellectual Property Rights in the Territory.
(j) All current and former employees and consultants who contributed to the discovery or development of any Existing Patent Rights did so pursuant to written agreements assigning all rights to such developed subject matter to Seller or an Affiliate of Seller.
(k) All maintenance fees, annuities and like payments required as of the date hereof with respect to each of the Existing Patent Rights have been timely paid.
(l) To the Knowledge of the Seller, no Third Party has a binding contractual right to prosecute any Patent Rights on behalf of Medtronic or Terumo. To the Knowledge of the Seller, Medtronic has not elected to not prosecute any of the Patent Rights pursuant to Section 11.6 of the Medtronic Agreement. To the Knowledge of the Seller, Terumo has not elected to not prosecute any of the Patent Rights pursuant to Section 12.3 of the Terumo Agreement.
Section 4.12 Indebtedness. Schedule 4.12 of the Disclosure Schedule sets forth a complete list of the outstanding Indebtedness for borrowed money of the Seller and its Subsidiaries as of the date hereof.
Section 4.13 Lien-Related Representation and Warranties. The Seller’s exact legal name is, and for the immediately preceding ten (10) years has been, “Orchestra BioMed Holdings, Inc.”. The Seller is, and for the prior ten (10) years has been, incorporated in the State of Delaware. The address of the chief executive office of the Seller is 150 Union Square Drive, New Hope, Pennsylvania 18938.
Section 4.14 Brokers’ Fees. There is no investment banker, broker, finder, financial advisor or other intermediary who has been retained by or is authorized to act on behalf of the Seller who might be entitled to any fee or commission from Buyer in connection with the transactions contemplated by this Agreement.
Section 4.15 Preemptive Rights. No Person is entitled to preemptive or similar statutory or contractual rights with respect to the issuance by the Seller of any securities of the Seller, including, without limitation, the Securities. The issuance and sale of the Securities hereunder will not obligate the Seller to issue shares of Seller Common Stock or other securities to any other Person (other than the Buyer) and will not result in the adjustment of the exercise, conversion, exchange or reset price of any outstanding security.
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Section 4.16 Valid Issuance. The Warrant Shares have been duly and validly authorized and reserved for issuance and, upon exercise of the Warrant in accordance with their respective terms, including the payment of any exercise price therefor, will be validly issued, fully paid and nonassessable and will be free and clear of all encumbrances and restrictions (other than those created by the Buyer), except for restrictions on transfer set forth in the Warrant or imposed by applicable securities laws. The Warrant Shares will be issued in compliance with all applicable federal and state securities laws.
Section 4.17 SEC Filings. The Seller has timely filed all reports, schedules, forms, statements and other documents required to be filed by the Seller under the Securities Act of 1933, as amended (the “Securities Act”), and the Securities Exchange Act of 1934, as amended (the “Exchange Act”), including pursuant to Sections 13(a) or 15(d) thereof, for the one year period preceding the date hereof (collectively, the “SEC Filings”). At the time of filing thereof, the SEC Filings complied in all material respects with the requirements of the Securities Act or the Exchange Act, as applicable, and the rules and regulations of the Securities and Exchange Commission thereunder and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements made therein, in the light of the circumstances under which they were made, not misleading.
Section 4.18 Compliance with Nasdaq Continued Listing Requirements. The Seller is in compliance with applicable Nasdaq continued listing requirements. There are no proceedings pending or threatened against the Seller relating to the continued listing of the Seller Common Stock on Nasdaq and the Seller has not received any notice of, nor is there any reasonable basis for, the delisting of the Seller Common Stock from Nasdaq.
Section 4.19 No Directed Selling Efforts or General Solicitation. Neither the Seller nor any Person acting on its behalf has conducted any general solicitation or general advertising in connection with the offer or sale of any of the Securities.
Section 4.20 No Integrated Offering. Neither the Seller nor any Person acting on its behalf has, directly or indirectly, made any offers or sales of any securities of the Seller or solicited any offers to buy any securities of the Seller, under circumstances that would adversely affect reliance by the Seller on Section 4(a)(2) for the exemption from registration for the transactions contemplated hereby or would require registration of the Securities under the Securities Act.
Section 4.21 Private Placement. The offer and sale of the Securities to the Buyer and the exercise of the Warrant are exempt from the registration requirements of the Securities Act pursuant to Section 4(a)(2). The issuance and sale of the Securities and the exercise of the Warrant do not and will not contravene the rules and regulations of Nasdaq.
Section 4.22 Investment Company. The Seller is not required to be registered as, and immediately following the Closing will not be required to register as, an “investment company” within the meaning of the Investment Company Act of 1940, as amended.
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Section 4.23 Shell Company Status. The Seller is not, and has never been, an issuer identified in Rule 144(i)(1).
Article 5
REPRESENTATIONS AND WARRANTIES OF THE BUYER
The Buyer hereby represents and warrants to the Seller as of the date hereof that:
Section 5.1 Existence; Good Standing. The Buyer is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware.
Section 5.2 Authorization. The Buyer has the requisite power and authority to execute, deliver and perform its obligations under this Agreement. The execution, delivery and performance of this Agreement, and the consummation of the transactions contemplated hereby, have been duly authorized by all necessary action on the part of the Buyer.
Section 5.3 Enforceability. This Agreement has been duly executed and delivered by an authorized person of the Buyer and constitutes the valid and binding obligation of the Buyer, enforceable against the Buyer in accordance with its terms, except as may be limited by applicable Bankruptcy Laws or by general principles of equity (whether considered in a proceeding in equity or at law).
Section 5.4 No Conflicts. The execution, delivery and performance by the Buyer of this Agreement do not and will not (a) contravene or conflict with the organizational documents of the Buyer, (b) contravene or conflict with or constitute a default under any material provision of any law binding upon or applicable to the Buyer or (c) contravene or conflict with or constitute a default under any material contract or other material agreement or Judgment binding upon or applicable to the Buyer.
Section 5.5 Consents. Except for any filings required by the federal securities laws or stock exchange rules, no consent, approval, license, order, authorization, registration, declaration or filing with or of any Governmental Entity or other Person is required to be done or obtained by the Buyer in connection with (a) the execution and delivery by the Buyer of this Agreement, (b) the performance by the Buyer of its obligations under this Agreement or (c) the consummation by the Buyer of any of the transactions contemplated by this Agreement.
Section 5.6 No Litigation. There is no action, suit, investigation or proceeding pending or, to the knowledge of the Buyer, threatened before any Governmental Entity to which the Buyer is a party that would, if determined adversely, reasonably be expected to prevent or materially and adversely affect the ability of the Buyer to perform its obligations under this Agreement.
Section 5.7 Financing. The Buyer has sufficient cash to pay the Purchase Price when due pursuant to Section 2.2. The Buyer acknowledges that its obligations under this Agreement are not contingent on obtaining financing.
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Article 6
COVENANTS
Section 6.1 Disclosures. Except for a press release previously approved in form and substance by the Seller and the Buyer or any other public announcement using substantially the same text as such press release or the press release set forth on Exhibit L, neither the Buyer nor the Seller shall, and each party hereto shall cause its respective Representatives, Affiliates and Affiliates’ Representatives not to issue a press release or other public announcement or otherwise make any public disclosure with respect to this Agreement or the subject matter hereof without the prior written consent of the other Party (which consent shall not be unreasonably withheld or delayed), except as may be required by applicable law or stock exchange rule (in which case the party hereto required to make the press release or other public announcement or disclosure shall allow the other party hereto reasonable time to comment on, and, if applicable, reasonably direct the disclosing party to seek confidential treatment in respect of portions of, such press release or other public announcement or disclosure in advance of such issuance).
Section 6.2 Information Rights. From and after the Closing Date, senior representatives of the Seller will meet at the request of the Buyer (no more often than once per calendar quarter) to discuss, among other things, material commercial, regulatory and intellectual property developments relating to the Products in the Territory, including the status of Medtronic’s and Terumo’s compliance with their respective development and commercialization obligations set forth in the Medtronic Agreement and Terumo Agreement, as applicable (each such meeting and, if applicable, related materials provided in response to Buyer’s request for additional information, an “Update Report”). The Seller shall also provide the Buyer with such additional information in its possession and control regarding the Products in the Territory included in each Update Report as the Buyer may reasonably request from time to time; provided that the Seller may redact information to the extent such information is not related to, and does not involve or affect, the Products or any rights of the Buyer under the Transaction Documents. The Seller and its Affiliates shall prepare and maintain, and shall use Commercially Reasonable Efforts to cause its Licensees and non-controlled Affiliates to prepare and maintain, reasonably complete and accurate records of the information to be disclosed in each Update Report and Revenue Report (together, the “Reports”). Promptly (and in any event no later than ten (10) Business Days) following the receipt by the Seller from or on behalf Medtronic, Terumo or any Third Party of any Medtronic Agreement Correspondence, any Terumo Agreement Correspondence or any Permitted License Correspondence, as applicable, the Seller shall furnish a copy of the same to the Buyer; provided, that to the extent any Medtronic Agreement Correspondence, Terumo Agreement Correspondence or Permitted License Correspondence has been provided to Buyer in a redacted form in order to comply with the confidentiality terms of the Medtronic Agreement, Terumo Agreement or Permitted License, as applicable, Seller shall, upon Buyer’s request, use commercially reasonable efforts to obtain approval from the applicable Licensee, to disclose (i) the redacted portions of such information to Buyer or (ii) a subset of the redacted portions of such information that the applicable Licensee is willing to permit disclosure to Buyer of, and, in each case, promptly following such approval, Seller provide such unredacted information to Buyer. All Reports, Medtronic Agreement Correspondence, Terumo Agreement Correspondence, Permitted License Correspondence and the Confidential Information contained therein, shall be the Confidential Information of Seller and subject to the obligations of confidentiality set forth in Article 8.
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Section 6.3 Revenue Payments; Revenue Participation and Revenue Payment Details.
(a) From and after the Closing Date, the Seller shall remit to the Buyer, without any Set-Off (subject, in each case, to Section 6.15), the Revenue Payment for each Calendar Quarter promptly, but in any event no later than sixty (60) calendar days after the end of each applicable Calendar Quarter; provided, however, that Revenue Payments in respect of Other Product Revenue shall not be due until such Other Product Revenue is actually received by the Seller or any of its Affiliates. A late fee of four percent (4%) over the Prime Rate (calculated on a per annum basis) will accrue on all unpaid amounts with respect to any Revenue Payment from the date such obligation was due. The imposition and payment of a late fee shall not constitute a waiver of the Buyer’s rights with respect to such payment default. The first Calendar Quarter for which a Revenue Payment is due shall be deemed to commence on the first Calendar Quarter following the Participation Start Date.
(b) From and after the first Calendar Quarter following the Participation Start Date, for each Calendar Quarter, promptly, but in any event no later than forty-five (45) calendar days after the end of each Calendar Quarter, the Seller shall provide to Buyer a report setting forth in reasonable detail (a “Revenue Report”): (i) Net Sales of the Products for the applicable Calendar Quarter and Calendar Year to date, on a country-by-country and Product-by-Product basis (including a break-down of all deductions from Gross Sales used to determine Net Sales and any Net Sales described in Section 6.6(f)), (ii) the Other Product Revenue for the applicable Calendar Quarter and Calendar Year to date, on a country-by-country and Product-by-Product basis (including an explanation of the payment and Contract giving rise to such Other Product Revenue) and (iii) (A) the calculation of the Revenue Payment payable to the Buyer for the applicable Calendar Quarter, identifying, on a country-by-country and Product-by-Product basis, the number of units of Products sold by the Seller and its Affiliates, and (B) foreign currency exchange rates used (which shall be rates of exchange determined in a manner consistent with the Seller’s method for calculating rates of exchange in the preparation of the Seller’s annual financial statements in accordance with GAAP).
(c) The Seller shall maintain a lockbox account for the purpose of making Revenue Payments hereunder (the “Lockbox Account”) and shall either: (i) direct the amount of the product of the applicable Included Product Revenue Royalty Rate multiplied by the applicable Included Product Revenue of Products to be paid directly to the Lockbox Account or (ii) within sixty (60) calendar days of the end of each Calendar Quarter, deposit into, or maintain an amount in, the Lockbox Account an amount equal to one hundred percent (100%) of the Revenue Payments payable to the Buyer by the Seller pursuant to this Agreement for the prior Calendar Quarter. The remittance of the Revenue Payments to the Buyer under this Section 6.3 shall be made first from the Lockbox Account and then from the Seller’s other accounts, if necessary. The Seller shall, on or prior to the date that is one hundred and twenty (120) days following the Closing, enter into a Deposit Agreement with the Depositary Bank and Buyer with respect to the Lockbox Account. Buyer shall have the right to exercise all of its rights and remedies under this Agreement including, without limitation, directing the Depositary Bank to transfer all of the funds in the Lockbox Account to Buyer. Seller shall have no right to terminate the Lockbox Account without Buyer’s prior written consent.
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(d) Any payments required to be made by either Party under this Agreement shall be made in United States Dollars via electronic funds transfer or wire transfer of immediately available funds to such bank account as the other Party shall designate in writing prior to the date of such payment.
Section 6.4 Inspections and Audits of the Seller. Following the Closing, upon at least ten (10) Business Days’ written notice and during normal business hours, no more frequently than once per Calendar Year, the Buyer may cause an inspection or audit by an independent public accounting firm reasonably acceptable to the Seller to be made of the Seller’s books of account for the two Calendar Years prior to the audit for the purpose of determining the correctness of Revenue Payments made under this Agreement. Upon the Buyer’s reasonable request, no more frequently than once per calendar year while any Out-License or Permitted License remains in effect, the Seller shall use Commercially Reasonable Efforts to exercise any rights it may have under any Out-License or Permitted License relating to the Products to cause an inspection or audit by an independent public accounting firm reasonably acceptable to Buyer to be made of the books of account of any counterparty thereto for the purpose of determining the correctness of the Revenue Payments made under this Agreement. All of the out-of-pocket expenses of any inspection or audit requested by the Buyer hereunder (including the fees and expenses of such independent public accounting firm designated for such purpose) shall be borne solely by the Buyer, unless the independent public accounting firm determines that the Revenue Payments previously paid during the period of the audit were underpaid by an amount greater than five percent (5%) of the Revenue Payments actually paid during such period, in which case such expenses shall be borne by the Seller. Such accounting firm will enter into a confidentiality agreement and an engagement letter reasonably acceptable to the Seller governing the use and disclosure of the Seller’s information disclosed to such accounting firm and such accounting firm’s acceptance of the procedures set forth in this Section 6.4. Such accounting firm shall not disclose the Confidential Information of the Seller or any such Licensee relating to the Products to the Buyer, except to the extent such disclosure is necessary to determine the correctness of Revenue Payments or otherwise would be included in a Report. All information obtained by the Buyer as a result of any such inspection or audit shall be Confidential Information of the Seller subject to Article 8. The Parties agree that the calculation of Net Sales of the Products and the Revenue Payments by such accounting firm contemplated by this Section 6.4 is to measure Net Sales of the Products and the Revenue Payments in accordance with the terms of this Agreement, and such calculation is not intended to permit the introduction of accounting methods, policies, principles, practices, procedures, classifications or estimation methodologies contrary to those specified in this Agreement for the purposes of determining Net Sales of the Products and the Revenue Payments. Such accounting firm shall provide a copy of its report to the Parties simultaneously. The Parties shall have thirty (30) calendar days from the date of delivery of such report to provide the accounting firm with comments on such report, which each Party shall deliver to the accounting firm and the other Party simultaneously. The accounting firm shall consider such comments in good faith and shall deliver an updated report within fifteen (15) calendar days of the earlier to occur of such thirty (30) day review period or the Parties’ written confirmation of submission of final comments to such accounting firm’s initial report. If the final report of the accounting firm in respect of an audit discloses any underpayments by the Seller to the Buyer, then such underpayment, shall be paid by the Seller to the Buyer within thirty (30) calendar days of it being so disclosed. If any audit discloses any overpayments by the Seller to the Buyer, then, the Seller shall have the right to credit the amount of the overpayment against each subsequent Calendar Quarter Revenue Payment due to the Buyer until the overpayment has been fully applied. If the overpayment is not fully applied prior to the final Calendar Quarter Revenue Payment due hereunder, the Buyer shall promptly refund an amount equal to any such remaining overpayment.
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Section 6.5 Inspections and Audits of Licensee. The Seller shall notify the Buyer in writing if it initiates an inspection or audit of the books of account of any counterparty to an Out-License. The Seller shall provide to the Buyer a copy of any audit report conducted with respect to an Out-License within ten (10) Business Days of receipt thereof. If any such audit discloses any underpayments by the applicable Licensee to the Seller, then any such underpayment shall be deemed Net Sales as of when such payment was due to the Seller and shall be subject to the Revenue Participation Right. If any such audit discloses any overpayments by the Licensee to Seller, then the Seller shall have the right to credit the amount of any overpayment actually returned to Licensee against each subsequent Calendar Quarter Revenue Payment due to the Buyer until the Revenue Participation Right with respect to such overpayment has been fully applied. If the overpayment is not fully applied prior to the final Calendar Quarter Revenue Payment due hereunder, the Buyer shall promptly refund an amount equal to any such remaining overpayment.
Section 6.6 Intellectual Property Matters.
(a) The Seller shall provide to the Buyer a copy of any written notice received by the Seller from a Third Party alleging or claiming that the making, having made, using, importing, offering for sale or selling of a Product infringes or misappropriates any Patents or other intellectual property rights of such Third Party, together with copies of material correspondence sent or received by the Seller related thereto, as soon as practicable and in any event not more than ten (10) Business Days following such delivery or receipt.
(b) If, to the Knowledge of the Seller, a Third Party infringes, or is suspected of infringing, any Patent Right, the Seller shall promptly inform the Buyer of such infringement or suspected infringement. Without limiting the foregoing, the Seller shall provide to the Buyer a copy of any written notice of any suspected infringement of any Patent Rights delivered or received by the Seller, as well as copies of material correspondence related thereto and such documentation and information related thereto as the Buyer reasonably requests, including, communications between the counterparty thereto and the Seller under the Medtronic Agreement, the Terumo Agreement or a Permitted License, in each case as soon as practicable and in any event not more than ten (10) Business Days following such delivery or receipt.
(c) The Seller shall keep the Buyer reasonably informed of, and shall consider in good faith any comments provided by the Buyer with respect to, any enforcement action of the Patent Rights under the Medtronic Agreement, Terumo Agreement or a Permitted License. To the extent Licensee enforces any of the Patent Rights in accordance with the Medtronic Agreement, Terumo Agreement or a Permitted License together with any other Patents owned or controlled by Licensee, the Seller agrees to negotiate in good faith with Licensee and agree to a reasonable allocation of proceeds as between the Patent Rights and any other Patents that were subject to such suit. In each such case, the Seller shall obtain and deliver to the Buyer an accounting detailing the proceeds allocated to the Patent Rights. Within ten (10) Business Days of initiating, or permitting a Licensee to initiate, an enforcement action regarding any suspected infringement by a Third Party of any Patent Right, the Seller shall provide the Buyer with written notice of such enforcement action.
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(d) Subject to the rights and obligations of any Licensees, licensors or co-owners of Patent Rights (including any counterparties to an In-License), the Seller shall (i) take any and all reasonably necessary actions, and prepare, execute, deliver and file any and all agreements, documents and instruments, that are reasonably necessary to diligently preserve and maintain the applicable Patents owned by Seller or its Affiliates included within the Patent Rights and with respect to which the Seller has prosecution rights (and, with respect to Patents licensed to Seller or its Affiliates and included within the Patent Rights, shall use Commercially Reasonable Efforts with respect thereto), including, as applicable, payment of maintenance fees or annuities, and (ii) shall use Commercially Reasonable Efforts with respect to the prosecution and maintenance of the Patent Rights.
(e) The Seller shall, with respect to any Patent Rights for which the Seller controls the prosecution and maintenance, (i) take any and all actions, and prepare, execute, deliver and file any and all agreements, documents and instruments, that are reasonably necessary or desirable (A) to diligently prosecute, preserve and maintain any such Patent Rights, including payment of maintenance fees or annuities on any such Patent Rights, and (B) to extend the term of any such Patent Rights or exclusivity period for the applicable Product (including any patent term extension(s) or supplementary protection certificate(s) with respect to any such Patent Rights, regulatory exclusivity periods with respect to such Product, or the like), in each case ((A) and (B)), including to the extent permitted in accordance with the Medtronic Agreement, the Terumo Agreement or a Permitted License; (ii) prosecute any corrections, substitutions, reissues, reviews, reexaminations and any other forms of patent term restoration of any such Patent Rights, including to the extent permitted in accordance with the Medtronic Agreement, the Terumo Agreement or a Permitted License; (iii) diligently enforce and defend any such Patent Rights, and defending any counterclaim of invalidity or unenforceability or action of a Third Party for declaratory judgment of non-infringement or non-interference, including to the extent permitted in accordance with the Medtronic Agreement, the Terumo Agreement or a Permitted License; and (iv) not disclaim or abandon, or fail to take any action necessary or desirable to prevent the disclaimer or abandonment (including through lack of enforcement against Third Party infringers) of, any such Patent Rights, including to the extent permitted in accordance with the Medtronic Agreement, the Terumo Agreement or a Permitted License. The Seller shall keep the Buyer reasonably informed of, and shall consider in good faith any comments provided by the Buyer with respect to, the activities under this Section 6.6(e).
(f) As between the Parties, the Seller’s actions required to be taken under this Section 6.5 shall be taken at the Seller’s sole expense. If the Seller recovers monetary damages from a Third Party in an action brought for such Third Party’s infringement of any Patent Rights in the Territory or relating to the Products and actions of such Third Party competitive with the Products in the Territory, where such damages, whether in the form of judgment or settlement, are awarded for such infringement of such Patent Rights, (i) such recovery will be allocated first to the reimbursement of any expenses incurred by the Seller or its Affiliates, or its licensors or licensees, in bringing such action (including all reasonable attorney’s fees) and (ii) any remaining amounts, to the extent payable to Seller or its Affiliates (excluding punitive or exemplary damages awarded) will be treated as Other Product Revenue with respect to the Territory.
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(g) The Buyer shall have the right to participate in any action, suit or other proceeding or any material meeting or material discussion relating to the infringement, legality, validity or enforceability of the Patent Rights, including any counterclaim, settlement discussions or meetings. The Seller acknowledges and agrees that it will not object to the Buyer participating in such action, suit or other proceeding or such meeting or discussion and will not assert that such participation could adversely affect the maintenance by the Seller of any applicable attorney-client privilege.
Section 6.7 In-Licenses.
(a) The Seller shall promptly (and in any event within ten (10) Business Days of the execution of any such document) provide the Buyer with (i) executed copies of any In-License entered into by the Seller or its Affiliates after the date hereof, and (ii) executed copies of each material amendment, supplement, modification or written waiver consummated after the date hereof of any provision of any In-License.
(b) The Seller shall use Commercially Reasonable Efforts to comply in all material respects with its obligations under any In-Licenses it enters into and shall not take any action or forego any action that would reasonably be expected to result in a material breach thereof. Promptly, and in any event within ten (10) Business Days, after receipt of any (written or oral) notice from a counterparty to any In-License or its Affiliates of an alleged material breach under any In-License, the Seller shall provide the Buyer a copy thereof. The Seller shall use its Commercially Reasonable Efforts to cure any material breaches by it under any In-License and shall give written notice to the Buyer upon curing any such breach. The Seller shall provide the Buyer with written notice following becoming aware of a counterparty’s material breach of its obligations under any In-License. The Seller shall not terminate any In-License without providing the Buyer prior written notice. Promptly, and in any event within ten (10) Business Days following the Seller’s notice to a counterparty to any In-License of an alleged breach by such counterparty under any such In-License, the Seller shall provide the Buyer a copy thereof.
Section 6.8 Out-Licenses.
(a) Subject to compliance with this Section 6.8, the Seller and its Affiliates may enter into an Out-License with a Third Party or enter into an agreement to develop, co-promote or Commercialize any Product in any portion of the Territory, for any fields of use or for all fields of use; provided, that such license shall not assign or otherwise convey title to or impose any Lien on any of the Product Rights or Product Collateral (any such Out-License or agreement, a “Permitted License”).
(b) The Seller shall promptly (and in any event within seven (7) Business Days) provide the Buyer with (i) an executed copy of any Out-License and (ii) executed copies of each amendment, supplement, modification or written waiver of any material provision of such Out-License.
(c) The Seller shall comply in all material respects with its obligations under the Medtronic Agreement, Terumo Agreement and any Permitted License it enters into, and shall not take any action or forego any action that would reasonably be expected to result in a material breach thereof. Promptly, and in any event within five (5) Business Days, after receipt of any written notice from a counterparty to any Out-License or its Affiliates of an alleged breach under any Out-License, the Seller shall provide the Buyer a copy thereof. The Seller shall keep the Buyer reasonably informed of, and consult with the Buyer regarding, any alleged breach under the Medtronic Agreement, Terumo Agreement or any Permitted License and shall consider in good faith any comments of the Buyer with respect to curing any such breach. The Seller shall cure any material breach by it under the Medtronic Agreement, Terumo Agreement or a Permitted License, and shall give written notice to the Buyer upon curing any material breach.
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(d) If, to the Knowledge of the Seller, a Licensee has materially breached, or is suspected of materially breaching any of its obligations under the Medtronic Agreement, Terumo Agreement or any Permitted License, the Seller shall provide the Buyer with prompt (and in any event within five (5) Business Days) written notice of such material breach or such suspected material breach. The Seller shall consult with the Buyer regarding the timing, manner and conduct of any enforcement of Licensee’s material obligations under the Medtronic Agreement, Terumo Agreement or any Permitted License, or regarding any material breach, material default or other material dispute under the Medtronic Agreement, Terumo Agreement or any Permitted License. Following such consultation, the Seller shall exercise such rights and remedies as the Seller reasonably determines is appropriate (including, if needed, causing its Affiliate to exercise such rights and remedies), and shall consider in good faith any comments of the Buyer with respect to exercising such rights and remedies, whether under the Medtronic Agreement, Terumo Agreement a Permitted License, or otherwise; provided, that, in determining whether Seller’s judgement or determination is “reasonably appropriate,” Seller shall be deemed to be acting or making a judgment in a reasonable manner if Seller would reasonably be expected to act in the same manner if Seller had the sole right, title and interest in and to, all of the Included Product Revenue. The Seller agrees to keep the Buyer reasonably informed of any actual or alleged material breach, material default or other material dispute related to the Medtronic Agreement, Terumo Agreement, a Permitted License, the Product, the Patent Rights, or the Revenue Payments and to provide copies as soon as practicable, but in any event within five (5) Business Days following the Seller’s receipt or delivery of (i) any written notice of any material breach or alleged material breach of the Medtronic Agreement, Terumo Agreement or a Permitted License or dispute related to the Product, the Patent Rights or the Revenue Payments and (ii) any and all filings, notices and written communications relating thereto. Notwithstanding anything to the contrary contained herein, if a Licensee has breached any obligation to make a payment to Seller or any of its Affiliates, Seller shall enforce compliance by Licensee with respect to such breach following Seller’s receipt of written request from Buyer with respect thereto.
(e) Each of the Buyer and the Seller shall bear its own fees and expenses incurred in enforcing Licensee’s obligations under the Medtronic Agreement, Terumo Agreement or any Permitted License. The proceeds resulting from any enforcement of Licensee’s obligations under the Medtronic Agreement, Terumo Agreement or any Permitted License shall be applied first to reimburse the Seller and the Buyer for any reasonable and documented expenses incurred by them in connection with such enforcement, with the remainder of the proceeds being treated as Other Product Revenue for purposes of calculating Revenue Payments under this Agreement.
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(f) Notwithstanding anything to the contrary herein, the Seller shall not amend, waive, modify, supplement or restate (or consent to any amendment, supplement, modification, waiver or restatement of) any provision of the Medtronic Agreement, Terumo Agreement or a Permitted License or enter into any contract having the effect of the foregoing: (i) without the prior written consent of the Buyer (such consent to be granted or withheld in the sole discretion of the Buyer), to the extent such action would reasonably be expected to adversely affect (A) the Buyer’s rights or economic interests under this Agreement, or (B) such counterparty’s right to use or exploit any Intellectual Property Rights licensed thereunder; or (ii) without the prior written consent of the Buyer (such consent not to be unreasonably withheld, conditioned or delayed) to the extent such action would not reasonably be expected to adversely affect any of the rights or assets in the foregoing clauses (A) through (B). In addition, the Seller shall not (1) exercise any right to terminate (either in whole or in part) the Medtronic Agreement, Terumo Agreement or a Permitted License or agree with the counterparty thereof to terminate (either in whole or in part) the Medtronic Agreement, Terumo Agreement or a Permitted License, (2) take, or permit any Affiliate or permitted sublicensee of Licensee to take, any action that would reasonably be expected to give the counterparty to the Medtronic Agreement, Terumo Agreement or a Permitted License the right to terminate (either in whole or in part) the Medtronic Agreement, Terumo Agreement or such Permitted License, or (3) sell, assign or otherwise transfer any or all of its interest under the Medtronic Agreement, Terumo Agreement or a Permitted License, except as permitted pursuant Section 11.4, or (4) permit any Licensee to sell, assign or otherwise transfer any or all of its interest under the Medtronic Agreement, Terumo Agreement or a Permitted License, in each case ((A) through (D)), without the Buyer’s prior written consent (such consent to be granted or withheld in the sole discretion of the Buyer). For the avoidance of doubt, the foregoing shall in no event apply to the Terumo Agreement. Notwithstanding anything to the contrary set forth in this Section 6.8(f), the Seller shall not be restricted from amending, waiving, modifying, supplement, restating, or terminating the Terumo Agreement if Seller reasonably believes that such action is appropriate with respect to the Terumo Dispute so long as such action is not taken by Seller with the intent of adversely and disproportionately effecting the timing, duration or amount of the Revenue Payments that Buyer is entitled to receive in respect of the Terumo Agreement. The Seller shall provide the Buyer with written notice promptly (and in any event within five (5) Business Days) following any termination or assignment, in each case, in whole or in part, of any Out-License.
(g) Without limiting any of the other provisions set forth in this Section 6.8, if Medtronic or Terumo terminates or provides written notice of termination of the Medtronic Agreement or Terumo Agreement, as applicable, (in whole or in part), or the Medtronic Agreement or Terumo Agreement otherwise terminates (in whole or in part), then the Seller shall pursue the negotiation of, and enter into, an applicable replacement license with respect to the Medtronic Agreement or Terumo Agreement, as applicable (any such license, a “New Arrangement”). The Buyer shall provide assistance to and cooperate with the Seller, at the Buyer’s cost and expense, in such efforts as the Seller shall undertake in connection with such New Arrangement. In the event the Seller enters into a New Arrangement, the Seller agrees to comply in all material respects with the provisions of this Agreement and references in this Agreement to the Medtronic Agreement or Terumo Agreement, as applicable, shall be deemed to be references to the new license agreement constructed under the New Arrangement, and references to Medtronic or Terumo, as applicable, shall be deemed to be references to the other party to such new license agreement and that other party’s Affiliates and sublicensees. Such New Arrangement shall also provide, for no additional consideration from the Buyer, that (i) the Buyer shall have the same rights as those acquired under the Medtronic Agreement or Terumo Agreement, as applicable, pursuant to this Agreement and (ii) all payments and other consideration thereunder shall constitute Other Product Revenue under this Agreement. The Seller will promptly and no later than with effect as of the date of such New Arrangement do all such acts and execute all such documents as the Buyer may reasonably specify (and in such form as the Buyer may reasonably require) to perfect the sale of Revenue Participation Right under this Agreement in respect of such New Arrangement.
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Section 6.9 Indebtedness. Prior to the expiration of the Revenue Payment Term, the Seller shall not, and shall not permit any of its Affiliates to, create, incur, assume or suffer to exist any Indebtedness for borrowed money other than Indebtedness under (i) the Hercules Loan Agreement so long as such Indebtedness is at all times subject to the Hercules Intercreditor Agreement and (ii) the Medtronic Loan Agreement so long as such Indebtedness is at all times subject to the Hercules Intercreditor Agreement and the Medtronic Intercreditor Agreement; provided, however, that upon the date that Buyer has actually received Revenue Payments equal to [***], Seller may, without the prior written consent of Buyer, create, incur, assume or suffer to exist any other unsecured or secured Indebtedness for borrowed money.
Section 6.10 Liens. Subject to Section 6.9, prior to the expiration of the Revenue Payment Term, the Seller shall not, and shall not permit any of its Affiliates to, create, incur, assume or suffer to exist any Liens other than Permitted Liens. Prior to the time set forth in Section 2.1(b), the Seller shall not, and shall not permit any of its Affiliates, to exist on the Revenue Participation Right and the Revenue Payments, any Liens except for Liens expressly permitted pursuant to clauses (a) and (e) of the definition of “Permitted Liens”.
Section 6.11 Negative Pledges. The Seller shall not enter into, incur or permit to exist, or permit any Subsidiary to enter into, incur or permit to exist, directly or indirectly, any agreement, instrument, deed, lease or other arrangement that prohibits, restricts or imposes any condition upon the ability of the Seller or any Subsidiary of the Seller to create, incur or permit to exist any Lien upon any of the Revenue Participation Right or the Product Collateral, whether now owned or hereafter acquired, or that requires the grant of any security for an obligation if security is granted for another obligation, except the following: (a) this Agreement, (b) restrictions or conditions imposed by any agreement relating to the Hercules Loan Agreement if such restrictions or conditions apply only to the property or assets securing such Indebtedness, (c) restrictions or conditions imposed by the Medtronic Loan Agreement so long as such Indebtedness is at all times subject to the Hercules Intercreditor Agreement and the Medtronic Intercreditor Agreement; (d) any customary restrictions and conditions contained in agreements relating to the sale or other disposition of assets or of a Subsidiary pending such sale or other disposition; provided that such restrictions and conditions apply only to the assets or Subsidiary to be sold or disposed of and such sale or disposition is permitted hereunder, and (e) customary provisions in leases restricting the assignment or sublet thereof.
Section 6.12 Dispositions. Prior to the expiration of the Revenue Payment Term, the Seller shall not, and shall not permit any of its Affiliates to, make any Disposition of all or any part of the Product Collateral, other than those Dispositions that are expressly permitted under this Agreement, which shall include, notwithstanding anything to the contrary herein, any Disposition made in connection with a Change of Control or Strategic Transaction, in each case, so long as the Seller causes the acquiror to deliver a writing to the Buyer in which it (a) assumes all of the obligations of the Seller to the Buyer under this Agreement and (b) acknowledges and agrees that the Liens and Back-Up Security Interest granted to the Buyer and its successors and assigns pursuant to this Agreement shall continue in effect following the consumption of such Disposition.
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Section 6.13 Commercialization.
(a) The Seller shall use Commercially Reasonable Efforts (either directly or through Affiliates or Licensees) to develop and Commercialize the Products in the Territory. Notwithstanding anything to the contrary herein, at all times a Commercialization Partner is in place, the Seller may satisfy the requirements of this Section 6.13(a)(a) by assisting its Commercialization Partner and performing its obligations under the applicable Out-License, and enforcing its Commercialization Partner’s obligations under the applicable Out-License.
(b) For three (3) years following the Closing Date, the Seller shall use the Purchase Price to support activities to develop the Products in the Territory.
Section 6.14 Efforts to Consummate Transactions. Subject to the terms and conditions of this Agreement, each of the Seller and the Buyer will use its commercially reasonable efforts prior to the Closing to take, or cause to be taken, all actions and to do, or cause to be done, all things reasonably necessary under applicable law to consummate the transactions contemplated by this Agreement. Each of the Buyer and the Seller agrees to execute and deliver such other documents, certificates, agreements and other writings and to take such other actions as may be reasonably necessary in order to consummate or implement expeditiously the transactions contemplated by this Agreement.
Section 6.15 Certain Tax Matters.
(a) The Seller and the Buyer agree that for all Tax purposes, (i) the Seller and the Buyer shall treat the transactions contemplated by this Agreement as a sale of the Revenue Participation Right and (ii) any amounts remitted by the Seller to the Buyer after the Closing Date pursuant to this Agreement shall be treated as received by the Seller as agent for the Buyer. The Parties agree not to take any position that is inconsistent with the provisions of this Section 6.15(a) on any tax return or in any audit or other tax-related administrative or judicial proceeding unless required by law or the good faith resolution of a tax audit. If there is an inquiry by any Governmental Entity of the Buyer or the Seller related to the treatment described in this Section 6.15(a), the Parties shall cooperate with each other in responding to such inquiry in a reasonable manner which is consistent with this Section 6.15(a).
(b) Notwithstanding anything to the contrary in this Agreement, each of the Buyer and the Seller shall be entitled to withhold and deduct (or cause to be withheld and deducted) from any amount payable under this Agreement to the other Party any Tax that the Buyer or the Seller, as applicable, determines that it is required to withhold and deduct under applicable law; provided that each of the Buyer and the Seller shall give the other Party prior notice and the opportunity, in good faith, to contest and prevent such withholding and deduction. In the event any such amounts are so withheld or deducted, the amount withheld or deducted shall be treated as having been paid to the Person in respect of which such amounts would otherwise have been paid for purposes of this Agreement. The Parties shall use commercially reasonable efforts to give or cause to be given to the other Party such assistance and such information concerning the reasons for withholding or deduction (including, in reasonable detail, the method of calculation for the deduction or withholding thereof) as may be reasonably necessary to enable the Buyer or the Seller, as applicable, to claim exemption therefrom, or credit therefor, or relief (whether at source or by reclaim) therefrom, and, in each case, shall furnish the Buyer or the Seller, as applicable, with proper evidence of the Taxes withheld and deducted and remitted to the relevant taxing authority.
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(c) If any deduction or withholding for or on account of any Indemnified Tax is required by applicable law to be made, and is made, from any payment to Buyer under this Agreement, then the Seller shall, within ten (10) Business Days after such deduction or withholding is made, make a payment to the Buyer so that, after all such required deductions and withholdings are made by any applicable withholding agent (including any deductions and withholdings required with respect to any additional payments under this Section 6.15(c)), the Buyer receives an amount equal to the amount that it would have received had no withholding of such Indemnified Taxes been made, except that the Seller shall have no obligation to pay the Buyer any additional amounts for or on account of any Indemnified Tax under this Section 6.15(c) to the extent such Indemnified Tax resulted from the Buyer’s breach of its obligations under Section 6.15(b).
(d) The Seller shall notify the Buyer in writing not more than thirty (30) days after becoming aware that any Indemnified Tax may be required with respect to any payment to Buyer under this Agreement.
(e) If Buyer is entitled to additional amounts pursuant to Section 6.15(c), then Buyer shall use commercially reasonable efforts to assign its rights and obligations hereunder to an Affiliate, if, in the reasonable judgment of Buyer, such assignment (i) would eliminate or reduce any additional amounts payable pursuant to Section 6.15(c) in the future and (ii) would not subject Buyer to any unreimbursed cost or expense and would not otherwise be disadvantageous to Buyer. The Seller hereby agrees to pay all reasonable out-of-pocket costs and expenses incurred by Buyer in connection with any such assignment.
(f) If and to the extent that the Seller pays any additional amount pursuant to Section 6.15(c) and the Buyer (acting in accordance with its obligations under Section 6.15(b)) has received and retained the benefit of a refund of the Tax to which the additional amount related, then the Buyer shall reimburse to the Seller an amount that is equal to such refund of Tax, net of any Tax imposed in respect of the receipt of such refund and any out-of-pocket costs to obtain such refund.
Section 6.16 Further Assurances. After the Closing, the Seller and the Buyer agree to execute and deliver such other documents, certificates, agreements and other writings and to take such other actions as may be reasonably necessary in order to give effect to the transactions contemplated by this Agreement. Any action to be taken hereunder by Seller is understood to include the obligation of Seller to cause its Affiliate to take or assist in the taking of such action, if necessary to perform the required action.
Section 6.17 Back-Up Security Interest. Notwithstanding anything herein to the contrary, the Seller shall not enter into (a) any Contracts that prohibit or restrict or otherwise knowingly take any action or knowingly fail to act in a manner that would, individually or in the aggregate, reasonably be expected to prohibit or restrict or otherwise materially and adversely affect the Revenue Participation Right, the Seller’s ability to pay the Revenue Payments or to grant a security interest to Buyer in the Revenue Participation Right, the Revenue Payments, or the Back-Up Security Interest, or (b) any Contracts, or amend, supplement, waive any rights under or otherwise modify any Contracts with the intent to circumvent any provision of this Agreement; provided, that nothing herein shall prevent the incurrence of any Permitted Lien so long as such incurrence does not expressly prohibit or restrict the Revenue Participation Right or the Seller from paying the Revenue Payments. The Seller shall not, without the Buyer’s prior written consent (such consent to be granted or withheld in the sole discretion of the Buyer), sell, assign or otherwise transfer all or any portion of its interest in the Product Collateral (other than inventory of the Product), except as permitted pursuant Section 11.4.
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Section 6.18 Event of Default. The occurrence of (a) any event of default (or equivalent term) under the Hercules Loan Agreement or (b) any event of default (or equivalent term) under the Medtronic Loan Agreement shall, in each case, constitute a material breach under this Agreement, shall accelerate all payments due or that may become due hereunder, and shall entitle Buyer to exercise all rights and remedies available to it under the Transaction Documents and applicable law.
Article 7
INDEMNIFICATION
Section 7.1 General Indemnity. From and after the Closing:
(a) the Seller hereby agrees to indemnify, defend and hold harmless the Buyer and its Affiliates and its and their directors, managers, trustees, officers, agents and employees (the “Buyer Indemnified Representatives”) from, against and in respect of all Losses suffered or incurred by the Buyer Indemnified Representatives to the extent arising out of or resulting from (i) any breach of any of the representations or warranties of the Seller in this Agreement, (ii) any breach of any of the covenants or agreements of the Seller in this Agreement, (iii) any Third Party Claim, to the extent such Third Party claim arises out of any Excluded Liabilities and Obligations, and (iv) any Third Party Claims in connection with the research, development, manufacture, use, or Commercialization by or on behalf of the Seller or any of its Affiliates or Licensees of any Product; and
(b) the Buyer hereby agrees to indemnify, defend and hold harmless the Seller and its Affiliates and its and their directors, officers, agents and employees (the “Seller Indemnified Representatives”) from, against and in respect of all Losses suffered or incurred by the Seller Indemnified Representatives to the extent arising out of or resulting from (i) any breach of any of the representations or warranties of the Buyer in this Agreement and (ii) any breach of any of the covenants or agreements of the Buyer in this Agreement.
Notwithstanding the foregoing, (A) the Seller will have no obligation to indemnify any Buyer Indemnified Representative to the extent that any Losses result from or arise out of any matters for which the Buyer is obligated to indemnify any Seller Indemnified Representative under Section 7.1(b) or to the extent that any Losses result from or arise out of any cases of fraud, gross negligence, or willful misconduct on the part of any Buyer Indemnified Representative and (B) the Buyer will have no obligation to indemnify any Seller Indemnified Representative to the extent that any Losses result from or arise out of any matters for which the Seller is obligated to indemnify any Buyer Indemnified Representative under Section 7.1(a) or into the extent that any Losses result from or arise out of any cases of fraud, gross negligence, or willful misconduct on the part of any Seller Indemnified Representative.
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Section 7.2 Claims Procedures.
(a) If either a Buyer Indemnified Representative, on the one hand, or a Seller Indemnified Representative, on the other hand (such Buyer Indemnified Representative on the one hand and such Seller Indemnified Representative on the other hand being hereinafter referred to as an “Indemnified Representative”), has suffered or incurred any Losses for which indemnification may be sought under this Article 7, the Indemnified Representative shall so notify the other Party from whom indemnification is sought under this Article 7 (the “Indemnifying Representative”) promptly in writing describing such Loss, the amount or estimated amount thereof, if known or reasonably capable of estimation, and the method of computation of such Loss, all with reasonable particularity and containing a reference to the provisions of this Agreement in respect of which such Loss shall have occurred. If any claim, action, suit or proceeding is asserted or instituted by or against a Third Party with respect to which an Indemnified Representative intends to claim any Loss under this Article 7 (a “Third Party Claim”), such Indemnified Representative shall promptly notify the Indemnifying Representative of such Third Party Claim and tender to the Indemnifying Representative the defense of such Third Party Claim. A failure by an Indemnified Representative to give notice and to tender the defense of such Third Party Claim in a timely manner pursuant to this Section 7.2 shall not limit the obligation of the Indemnifying Representative under this Article 7, except to the extent such Indemnifying Representative is actually prejudiced thereby.
(b) The Indemnifying Representative will be entitled to participate in the defense of any Third Party Claim that is the subject of a notice given by or on behalf of any Indemnified Representative pursuant to Section 7.2(a). In addition, the Indemnifying Representative will have the right to defend the Indemnified Representative against the Third Party Claim with counsel of its choice reasonably satisfactory to the Indemnified Representative so long as (i) the Indemnifying Representative gives written notice that they or it will defend the Third Party Claim to the Indemnified Representative within thirty (30) days after the Indemnified Representative has given notice of the Third Party Claim under Section 7.2(a) stating that the Indemnifying Representative will, and thereby covenants to, indemnify, defend and hold harmless the Indemnified Representative from and against the entirety of any and all Losses the Indemnified Representative may suffer resulting from, arising out of, relating to, in the nature of, or caused by the Third Party Claim, (ii) the Third Party Claim involves only money damages and does not seek an injunction or other equitable relief, (iii) the Indemnified Representative has not been advised by counsel that an actual or potential conflict exists between the Indemnified Representative and the Indemnifying Representative in connection with the defense of the Third Party Claim and (iv) the Third Party Claim does not relate to or otherwise arise in connection with any criminal action, suit, investigation or proceeding.
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(c) The Indemnifying Representative will not consent to the entry of any Judgment or enter into any compromise or settlement with respect to the Third Party Claim without the prior written consent of the Indemnified Representative (which consent will not be unreasonably withheld, conditioned or delayed) unless such Judgment, compromise or settlement (i) provides for the payment by the Indemnifying Representative of money as sole relief for the claimant, (ii) results in the general release of all Indemnified Representatives and its Affiliates from all liabilities arising or relating to, or in connection with, the Third Party Claim, and (iii) involves no finding or admission of any violation of law or the rights of any Person and no effect on any other claims that may be made against the Indemnified Representative or any of its Affiliates.
(d) If the Indemnifying Representative does not deliver the notice contemplated by Section 7.2(a), within thirty (30) days after the Indemnified Representative has given notice of the Third Party Claim pursuant to Section 7.2(a), or otherwise at any time fails to conduct the defense of the Third Party Claim diligently, the Indemnified Representative may defend, and may consent to the entry of any Judgment or enter into any compromise or settlement with respect to, the Third Party Claim in any manner it may deem appropriate following consultation with the Indemnifying Representative in connection therewith. If such notice and evidence is given on a timely basis and the Indemnifying Representative conducts the defense of the Third Party Claim diligently but any of the other conditions in Section 7.2(b) is or becomes unsatisfied, the Indemnified Representative may defend, and may consent to the entry of any Judgment or enter into any compromise or settlement with respect to, the Third Party Claim; provided, that the Indemnifying Representative will not be bound by the entry of any such judgment consented to, or any such compromise or settlement effected, without its prior written consent (which consent will not be unreasonably withheld, conditioned or delayed).
Section 7.3 Limitations on Liability; Time for Claims.
(a) Except in cases of fraud, gross negligence, or willful misconduct, no Party shall be liable for any lost profits or revenue, lost opportunity or consequential, punitive, special or incidental damages under this Article 7 (and no claim for indemnification hereunder shall be asserted) as a result of any breach or violation of any covenant or agreement of such Party (including under this Article 7) in or pursuant to this Agreement. In connection with the foregoing, the Parties acknowledge and agree that (i) the Buyer’s damages, if any, for any such action or claim will typically include Losses for payment of the Revenue Payments that the Buyer was entitled to receive or would have received absent such breach, in each case in respect of its ownership of the Revenue Payments, as well as expenses incurred in connection with enforcement of this Agreement, and (ii) the Buyer shall be entitled to make claims for all such missing, delayed or diminished Revenue Payments as Losses hereunder, and such missing, delayed or diminished Revenue Payments shall not be deemed consequential, punitive, special, indirect or incidental damages.
(b) Notwithstanding anything to the contrary herein, (i) the Seller’s aggregate liability in respect of claims for indemnification pursuant to Section 7.1(a)(i) will not exceed the Purchase Price actually paid to Seller hereunder; and (ii) the Buyer’s aggregate liability in respect of claims for indemnification pursuant to Section 7.1(b) will not exceed the sum of the Purchase Price actually paid to Seller hereunder.
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(c) No claim may be made or suit instituted seeking indemnification pursuant to Section 7.1(a)(i) or Section 7.1(b)(i) unless a written notice is provided to the Seller or Buyer, as applicable, prior to the date that is twenty-four (24) months following the Closing. No claim may be made or suit instituted seeking indemnification pursuant to any other provision of Section 7.1(a) or Section 7.1(b) unless a written notice is provided to the Seller or Buyer, as applicable, prior to the date that is the three (3) months after the termination of this Agreement.
Section 7.4 Tax Treatment of Indemnification Payments. For all purposes hereunder, any indemnification payments made pursuant to this Article 7 will be treated as an adjustment to the Purchase Price for all Tax purposes to the fullest extent permitted by applicable law.
Section 7.5 Exclusive Remedy. Except as set forth in Section 11.11, the Parties acknowledge and agree that after the Closing, the indemnification provisions of this Article 7 shall be the sole and exclusive remedies of the Parties for any breach of the representations or warranties or nonperformance of or default under any covenants or agreements by either Party contained in this Agreement or any agreement, certificate or document signed and delivered by either Party in connection with this Agreement (other than (a) claims for equitable relief or (b) claims of, or causes of action arising from fraud). Notwithstanding the foregoing, the rights of the Buyer under the Hercules Intercreditor Agreement and the Medtronic Intercreditor Agreement, and the rights of the Buyer and the Seller for claims for fraud, gross negligence, or willful misconduct, shall be not be waived or limited in any way by this Article 7.
Article 8
CONFIDENTIALITY
Section 8.1 Confidentiality. Except as provided in this Article 8, Section 11.4 or otherwise agreed in writing by the Parties, the Parties agree that, during the term of this Agreement and for five (5) years thereafter, each Party (the “Receiving Party”) shall (a) keep confidential and shall not publish or otherwise disclose to any Person any Confidential Information (as defined below) and (b) and shall not use for any purpose other than as provided for in this Agreement (which such permitted purpose includes the exercise of any rights or the performance of any obligations hereunder) the terms of this Agreement or any information (whether written or oral, or in electronic or other form and, for purpose of clarity including the Counterparty Confidential Information) furnished (including prior to the date hereof) to it by or on behalf of the other Party (the “Disclosing Party”) pursuant to this Agreement or the Confidentiality Agreement (such information, “Confidential Information” of the Disclosing Party), provided that the terms of this Agreement shall be Confidential Information of both Parties and the Counterparty Confidential Information, as between the Buyer and the Seller, shall at all times be Confidential Information of the Seller. Notwithstanding the foregoing, the restrictions on disclosure and use of Confidential Information of the Disclosing Party shall not apply to Confidential Information that:
(a) was already known to the Receiving Party, as evidenced by the Receiving Party’s written records, other than under an obligation of confidentiality, at the time of disclosure by the Disclosing Party;
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(b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party;
(c) became generally available to the public or otherwise became part of the public domain after its disclosure to the Receiving Party and other than through any act or omission of the Receiving Party in breach of this Agreement or any other Contract;
(d) is independently discovered or developed by the Receiving Party or any of its Affiliates, as evidenced by their written records, without the use, reference to, or reliance upon, the Confidential Information of the Disclosing Party; or
(e) is subsequently disclosed to the Receiving Party on a non-confidential basis by a Third Party without obligations of confidentiality with respect thereto.
Section 8.2 Authorized Disclosure.
(a) The Receiving Party may disclose Confidential Information of the Disclosing Party or to the extent such disclosure is reasonably necessary in the following situations:
(i) prosecuting or defending litigation;
(ii) complying with applicable laws and regulations (including the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, and regulations promulgated by securities exchanges);
(iii) complying with a valid order of a court of competent jurisdiction or other Governmental Entity or as otherwise required by applicable law or regulation; provided, however, that the Receiving Party shall first have given notice to the Disclosing Party and given the Disclosing Party a reasonable opportunity to quash such order and to obtain a protective order requiring or requesting that the Confidential Information and documents that are the subject of such order be held in confidence by such court or Governmental Entity or, if disclosed, be used only for the purposes for which the order was issued; and further provided that if a disclosure order is not quashed or a protective order is not obtained, the Confidential Information disclosed in response to such court or governmental order or applicable law or regulation shall be limited to that information which is legally required or requested to be disclosed in response to such court or governmental order or pursuant to such applicable law or regulation;
(iv) for regulatory, Tax or customs purposes;
(v) for audit purposes, provided that each recipient of Confidential Information must be bound by customary and reasonable obligations of confidentiality and non-use prior to any such disclosure;
(vi) disclosure to its Affiliates and Representatives, provided that each such recipient of Confidential Information must be bound by contractual or professional obligations of confidentiality and non-use at least as stringent as those imposed upon the Parties hereunder prior to any such disclosure;
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(vii) upon the prior written consent of the Disclosing Party;
(viii) disclosure to its actual and potential investors, and other sources of funding, including debt financing, or actual or potential partners, collaborators or acquirers, and their respective accountants, financial advisors and other professional representatives, provided, that such disclosure shall be made only to the extent customarily required to consummate such investment, financing transaction, partnership, collaboration or acquisition and, thereafter, to monitor and exercise rights in connection therewith, and that each recipient of Confidential Information must be bound by customary obligations of confidentiality and non-use prior to any such disclosure; or
(ix) as is necessary in connection with a permitted assignment pursuant to Section 11.4.
(b) Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.2(a)(i), Section 8.2(a)(ii), Section 8.2(a)(iii) or Section 8.2(a)(iv), it will give reasonable advance notice to the Disclosing Party of such disclosure (including providing a draft of the proposed disclosure reasonably in advance of disclosure to the extent permitted by applicable law) and consider in good faith reasonable comments thereto, and shall use commercially reasonable efforts to secure confidential treatment of such information. In any event, the Buyer shall not file any patent application based upon or using the Confidential Information of the Seller provided hereunder.
Section 8.3 Termination of Confidentiality Agreement. Effective upon the date hereof, the Confidentiality Agreement is hereby terminated without further force and effect, superseded by the provisions of this Article 8 of this Agreement and all obligations between the Parties relating to confidentiality shall be governed by this Article 8.
Article 9
TERMINATION
Section 9.1 Mutual Termination. This Agreement may be terminated by mutual written agreement of the Buyer and the Seller.
Section 9.2 Termination Prior to Closing. This Agreement may be terminated by either Buyer or Seller upon delivery of written notice to the other if the Closing has not occurred on or prior to August 15, 2025; provided that neither Party shall be entitled to terminate the Agreement pursuant to this Section 9.2 if such Party is then in material breach of any of its obligations hereunder or pursuant to the Equity Purchase Agreement.
Section 9.3 Automatic Termination. Unless earlier terminated as provided in Section 9.1, this Agreement shall continue in full force and effect until sixty (60) calendar days after the expiration of the Revenue Payment Term, at which point this Agreement shall automatically terminate, except with respect to any rights that shall have accrued prior to such termination.
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Section 9.4 Effect of Termination. Upon termination of this Agreement pursuant to this Article 9, the Liens and Back-Up Security Interest granted to the Buyer and its successors and assigns pursuant to this Agreement shall be automatically released without any further action necessary. In furtherance of the foregoing, the Buyer shall promptly file UCC-3 terminations and deliver to the Seller a lien release letter, in each case, releasing such Liens and Back-Up Security Interest, and execute and deliver to the Seller, at the Seller’s expense, all other documents that the Seller shall reasonably request to evidence such release.
Section 9.5 Survival. Notwithstanding anything to the contrary in this Article 9, the following provisions shall survive termination of this Agreement: Section 6.3 (Revenue Payments; Revenue Participation and Revenue Payment Details) (solely with respect to amounts accrued prior to expiration or termination but not paid), Section 6.4 (Inspection and Audits of the Seller), Section 6.5 (Inspection and Audits of Licensee), Article 7 (Indemnification), Article 8 (Confidentiality), Section 9.4 (Effect of Termination), this Section 9.5 (Survival) and Article 10 (Miscellaneous). Termination of the Agreement shall not relieve any Party of liability in respect of breaches under this Agreement by any Party on or prior to termination.
Article 10
SECURITY INTEREST
Section 10.1 Grant of Security Interest. As security for the performance by the Seller of all the terms, covenants and agreements on the part of the Seller to be performed under this Agreement and the other Transaction Documents, including the punctual payment when due of the Revenue Payments, Milestone Payment and each other obligation of the Seller hereunder, and subject in all respects to the provisions of Section 2.1(b), each Pledgor grants to Buyer a security interest in all of such Pledgor’s right, title, and interests in, the Revenue Participation Right, the Revenue Payments and the Product Collateral, including the obligations to remit the Revenue Payments, and all Proceeds (as defined in the UCC) of the foregoing, whether now owned or hereafter acquired (collectively, the “Collateral”).
Section 10.2 Further Assurances.
(a) The Pledgors shall, from time to time execute, deliver and file any financing statements, the IP Security Agreement, other security agreements, notices or other documents to perfect, give the highest priority to the Buyer’s Lien on the Collateral (other than any Lien expressly permitted by clause (a) of the definition of “Permitted Liens” and solely to the extent contemplated by and subject to the Hercules Intercreditor Agreement and Medtronic Intercreditor Agreement) or otherwise evidence the Buyer’s rights herein. The Pledgors shall from time to time procure any instruments or other documents as may be reasonably requested by the Buyer, and to take all further action that may be necessary or advisor o that the Buyer may reasonably request, to perfect and protect the Liens granted hereby. In addition, and for such purposes only, each Pledgor hereby authorizes the Buyer to execute and deliver on behalf of such Pledgor and to file such financing statements, the IP Security Agreement, security agreements, notices or other documents without the signature of such Pledgor either in Buyer’s name or in the name of Buyer, as agent and attorney-in-fact for such Pledgor. Each Pledgor shall protect and defend its title to the Collateral and Buyer’s Lien thereon against all Persons claiming any interest adverse to such Pledgor or Buyer other than Liens expressly permitted pursuant to clauses (a) and (e) of the definition of “Permitted Liens”.
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(b) On or before the Closing Date, the Pledgors will execute and deliver to the Buyer such patent and trademark security agreements as the Buyer may reasonably request, on the form set forth hereto as Exhibit G (the “IP Security Agreement”), and will record such agreements with the U.S. Patent and Trademark Office. Within forty-five (45) days of the last day of the fiscal quarter during which the Closing Date occurred and each fiscal quarter ending thereafter, the Seller will notify the Buyer in writing of the creation or acquisition of any Intellectual Property Rights owned by the Seller or its Subsidiaries that is registered or becomes registered or the subject of an application for registration with the U.S. Patent and Trademark Office, in each case during such fiscal quarter then ended, and to the extent constituting Collateral, will record or will cause the applicable Pledgor to record, a further IP Security Agreement (or amendment to an existing IP Security Agreement) in each case in form and substance reasonably acceptable to the Buyer with the U.S. Patent and Trademark Office, and will take such other action as may be necessary or as the Buyer may reasonably request to perfect the Buyer’s security interest in such Intellectual Property Rights. As between The Pledgors and their Affiliates, the Pledgors own and will continue to own all Product Rights.
Section 10.3 Remedies.
(a) Upon the occurrence and during the continuation of an Event of Default, subject in all cases to the Hercules Intercreditor Agreement and Medtronic Intercreditor Agreement, as applicable, the Buyer shall have the rights and remedies of a secured party under the UCC in effect on the date thereof including, without limitation, the right to take possession of any of the Product Collateral or the proceeds thereof, to sell or otherwise dispose of the same, to apply the proceeds therefrom to any of the obligations of Seller hereunder to remit the Revenue Share Payments in such order as Buyer, in its sole discretion, may elect. Buyer shall give Seller reasonable written notice of the time and place of any public sale of the Product Collateral or the time after which any other intended disposition thereof is to be made. The requirement of sending reasonable notice shall be met if such notice is given to Borrower at least ten (10) days before such disposition. Expenses of retaking, holding, insuring, preserving, protecting, preparing for sale or selling or the like with respect to the Product Collateral (including reasonable attorney’s fees and other legally recoverable collection expenses) will constitute obligations hereunder.
(b) Upon any Event of Default, the Buyer may (i) declare all or any portion of the obligations or other amounts hereunder then outstanding to be accelerated and due and payable, whereupon all or such portion of such obligations and other amounts shall become due and payable immediately and (ii) exercise any and all of its other rights and remedies under applicable law, hereunder and under the other Transaction Documents; provided, however, that upon the occurrence of any Event of Default as a result of the commencement of any Insolvency Proceeding with respect to the Seller or any of its Subsidiaries, without any notice to Seller or any other Person or any act by the Buyer, all obligations and other amounts then outstanding shall be accelerated and become due and payable automatically and immediately, without presentment, demand, protest or notice of any kind, all of which are expressly waived by the Seller.
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Article 11
MISCELLANEOUS
Section 11.1 Headings. The table of contents and the descriptive headings of the several Articles and Sections of this Agreement and the Exhibits and Schedules are for convenience only, do not constitute a part of this Agreement and shall not control or affect, in any way, the meaning or interpretation of this Agreement.
Section 11.2 Notices. All notices and other communications under this Agreement shall be in writing and shall be effective (a) when delivered by hand, if personally delivered, (b) when sent, if by email with PDF attachment, with an acknowledgement of receipt being produced by the recipient’s email account, (c) upon receipt, if sent through the mails, registered or certified mail, return receipt requested, postage prepaid, with such receipt to be effective the date of delivery indicated on the return receipt, or (d) upon receipt, if sent by an overnight courier, in all cases, with a copy emailed to the recipient at the applicable address, addressed to the recipient as follows:
If to the Seller or any Pledgor, to it at:
Orchestra BioMed Holdings, Inc.
150 Union Square Drive
New Hope, PA 18938
Attention: David P. Hochman, Chief Executive Officer
Email: [Omitted Pursuant to Item 601(a)(6)]
with a copy (which shall not constitute notice) to:
Paul Hastings LLP
200 Park Avenue
New York, NY 10166
Attention: Samuel A. Waxman
Email: [Omitted Pursuant to Item 601(a)(6)]
If to the Buyer, to it at:
Ligand Pharmaceuticals, Inc.
555 Heritage Drive, Suite 200
Jupiter, Florida 33458
Attention: Paul Hadden; Andrew Reardon
Email: [Omitted Pursuant to Item 601(a)(6)]
With a copy to (which shall not constitute notice) to:
Ropes & Gray LLP
Prudential Tower
800 Boylston Street
Boston, MA 02199-3600
Attention: Melissa Rones
Email: [Omitted Pursuant to Item 601(a)(6)]
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Each Party may, by notice given in accordance herewith to the other Party, designate any further or different address to which subsequent notices and other communications shall be sent.
Section 11.3 Expenses. Except as otherwise provided herein, all fees, costs and expenses (including any legal, accounting and banking fees) incurred in connection with the preparation, negotiation, execution and delivery of this Agreement and to consummate the transactions contemplated hereby shall be paid by the Party hereto incurring such fees, costs and expenses. Notwithstanding the foregoing, following the Closing, the Seller shall reimburse the Buyer for all Third Party out-of-pocket fees and expenses directly incurred in connection with the transactions contemplated under this Agreement and the Transaction Documents, such reimbursement not to exceed $600,000 in the aggregate (inclusive of the $75,000 deposit received by the Buyer).
Section 11.4 Assignment. The Seller may not assign in whole or in part this Agreement, or any of its rights or obligations hereunder, without the Buyer’s prior written consent, except to (a) an Affiliate or (b) a Third Party in connection with a Change of Control or Strategic Transaction, provided that the Seller causes such Affiliate or Third Party, as applicable, to deliver a writing to the Buyer in which it assumes all of the obligations of the Seller to the Buyer under this Agreement, and such Affiliate or Third Party shall be deemed an assignee of the Seller under this Agreement; provided, further, that with respect to an assignment of this Agreement to a Third Party in connection with a Strategic Transaction that only involves the Product Rights related to one Product, (i) Seller shall only be permitted to assign the Agreement in part, (ii) such Third Party acquiror shall assume all obligations of the Seller with respect to the Product Rights and Product sold in such Strategic Transaction, and (iii) Seller shall remain liable to Buyer for all of its obligations hereunder with respect to the Product and Product Rights not sold in such Strategic Transaction. Following the Closing, the Buyer may assign this Agreement in whole or in part to any Person, including to any Third Party or to one or more of its Affiliates; provided that (i) the Buyer shall cause such Person (y) to become a party to the Hercules Intercreditor Agreement and the Medtronic Intercreditor Agreement, in each case, in accordance with the terms thereof and (z) to deliver a writing to the Seller in which it assumes all of the covenants, undertakings and obligations of the Buyer to the Seller, and (ii) the Seller’s prior written consent shall be required for any assignment that is (x) prior to the Second Installment Payment Date (y) after the Second Installment Payment Date, solely to the extent that Buyer has not paid to the Seller the Second Installment and Seller has delivered to Buyer prior to the Second Installment Payment Date the certificate certifying the conditions precedent to such payment in accordance with Section 3.02(b), or (z) to a Strategic Acquiror or a Proscribed Person. This Agreement shall be binding upon, inure to the benefit of and be enforceable by, the Parties and their respective permitted successors and assigns. Any purported assignment in violation of this Section 11.4 shall be null and void.
Section 11.5 Amendment and Waiver.
(a) This Agreement may be amended, modified or supplemented only in a writing signed by each of the Parties. Any provision of this Agreement may be waived only in a writing signed by the Party granting such waiver.
(b) No failure or delay on the part of any Party in exercising any right, power or remedy hereunder shall operate as a waiver thereof, nor shall any single or partial exercise of any such right, power or remedy preclude any other or further exercise thereof or the exercise of any other right, power or remedy. No course of dealing between the Parties shall be effective to amend, modify, supplement or waive any provision of this Agreement.
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Section 11.6 Entire Agreement. This Agreement, the Exhibits annexed hereto and the Disclosure Schedule constitute the entire understanding between the Parties with respect to the subject matter hereof and supersede all other understandings and negotiations with respect thereto.
Section 11.7 No Third Party Beneficiaries. This Agreement is for the sole benefit of the Seller and the Buyer and their permitted successors and assigns and nothing herein expressed or implied shall give or be construed to give to any Person, other than the Parties and such successors and assigns, any legal or equitable rights hereunder, except that the Indemnified Representatives shall be third party beneficiaries of the benefits provided for in Section 7.1.
Section 11.8 Governing Law. This Agreement shall be governed by, and construed in accordance with, the laws of the State of New York without giving effect to any choice or conflict of law provision or rule that would cause the application of the laws of any other jurisdiction.
Section 11.9 Jurisdiction; Venue.
(a) EACH OF THE PARTIES HERETO HEREBY IRREVOCABLY AND UNCONDITIONALLY SUBMITS, FOR ITSELF AND ITS RESPECTIVE PROPERTY AND ASSETS, TO THE EXCLUSIVE JURISDICTION OF ANY NEW YORK STATE COURT OR FEDERAL COURT OF THE UNITED STATES OF AMERICA SITTING IN NEW YORK COUNTY, NEW YORK, AND ANY APPELLATE COURT THEREOF, IN ANY ACTION OR PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT, OR FOR RECOGNITION OR ENFORCEMENT OF ANY JUDGMENT IN RESPECT THEREOF, AND THE BUYER AND THE SELLER HEREBY IRREVOCABLY AND UNCONDITIONALLY AGREE THAT ALL CLAIMS IN RESPECT OF ANY SUCH ACTION OR PROCEEDING MAY BE HEARD AND DETERMINED IN ANY SUCH NEW YORK STATE COURT OR, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, IN SUCH FEDERAL COURT. THE BUYER AND THE SELLER HEREBY AGREE THAT A FINAL JUDGMENT IN ANY SUCH ACTION OR PROCEEDING SHALL BE CONCLUSIVE AND MAY BE ENFORCED IN OTHER JURISDICTIONS BY SUIT ON THE JUDGMENT OR IN ANY OTHER MANNER PROVIDED BY APPLICABLE LAW. EACH OF THE BUYER AND THE SELLER HEREBY SUBMITS TO THE EXCLUSIVE PERSONAL JURISDICTION AND VENUE OF SUCH NEW YORK STATE AND FEDERAL COURTS. THE BUYER AND THE SELLER AGREE, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, THAT PROCESS MAY BE SERVED ON THE BUYER OR THE SELLER IN THE SAME MANNER THAT NOTICES MAY BE GIVEN PURSUANT TO Section 11.2 HEREOF.
(b) EACH OF THE PARTIES HERETO HEREBY IRREVOCABLY AND UNCONDITIONALLY WAIVES, TO THE FULLEST EXTENT IT MAY LEGALLY AND EFFECTIVELY DO SO, ANY OBJECTION THAT IT MAY NOW OR HEREAFTER HAVE TO THE LAYING OF VENUE OF ANY ACTION OR PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT IN ANY NEW YORK STATE OR FEDERAL COURT. EACH OF THE BUYER AND THE SELLER HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, THE DEFENSE OF AN INCONVENIENT FORUM TO THE MAINTENANCE OF SUCH ACTION OR PROCEEDING IN ANY SUCH COURT.
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(c) EACH PARTY HEREBY JOINTLY AND SEVERALLY WAIVES ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY ACTION OR PROCEEDING RELATING TO THIS AGREEMENT OR ANY OTHER DOCUMENT DELIVERED HEREUNDER OR IN CONNECTION HEREWITH, OR ANY TRANSACTION ARISING FROM OR CONNECTED TO ANY OF THE FOREGOING. EACH OF THE PARTIES REPRESENTS THAT THIS WAIVER IS KNOWINGLY, WILLINGLY, AND VOLUNTARILY GIVEN.
Section 11.10 Severability. If any term or provision of this Agreement shall for any reason be held to be invalid, illegal or unenforceable in any situation in any jurisdiction, then, to the extent that the economic and legal substance of the transactions contemplated hereby is not affected in a manner that is materially adverse to either Party, all other terms and provisions of this Agreement shall nevertheless remain in full force and effect and the enforceability and validity of the offending term or provision shall not be affected in any other situation or jurisdiction.
Section 11.11 Specific Performance. Each of the Parties acknowledges and agrees that the other Party may be damaged irreparably in the event any of the provisions of this Agreement are not performed in accordance with their specific terms or otherwise are breached or violated. Accordingly, each of the Parties agrees that, without posting bond or other undertaking, the other Party will be entitled to seek an injunction or injunctions to prevent breaches or violations of the provisions of this Agreement and to seek to enforce specifically this Agreement and the terms and provisions hereof in any action, suit or other proceeding instituted in any court of the United States or any state thereof having jurisdiction over the Parties and the matter in addition to any other remedy to which it may be entitled, at law or in equity. Each of the Parties further agrees that, in the event of any action for specific performance in respect of such breach of violation, it will not assert the defense that a remedy at law would be adequate.
Section 11.12 Counterparts. This Agreement may be executed in any number of counterparts and by the Parties in separate counterparts, each of which when so executed shall be deemed to be an original and all of which taken together shall constitute one and the same agreement. Copies of executed counterparts transmitted by telecopy, facsimile or other similar means of electronic transmission, including “PDF,” shall be considered original executed counterparts.
Section 11.13 Relationship of the Parties. The relationship between the Buyer and the Seller is solely that of purchaser and seller, and neither the Buyer nor the Seller has any fiduciary or other special relationship with the other Party or any of its Affiliates. This Agreement is not a partnership or similar agreement, and nothing contained herein shall be deemed to constitute the Buyer and the Seller as a partnership, an association, a joint venture or any other kind of entity or legal form for any purposes, including any Tax purposes. The Buyer and the Seller agree that they shall not take any inconsistent position with respect to such treatment in a filing with any Governmental Entity.
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Section 11.14 Intercreditor Agreement. Notwithstanding anything to the contrary herein, the Liens and Back-Up Security Interest granted to the Buyer and its successors and assigns pursuant to this Agreement and the exercise of any right or remedy by the Buyer and its successors and assigns hereunder are subject to the provisions of the Hercules Intercreditor Agreement and Medtronic Intercreditor Agreement. If there is a conflict between the terms of the Hercules Intercreditor Agreement or the Medtronic Intercreditor Agreement (the “Controlling Agreement”), on the one hand, and the terms of this Agreement, on the other hand, with respect to the Back-Up Security Interest or the exercise of any right or remedy of the Buyer or any holder of any Indebtedness that is a party to a Controlling Agreement, then the terms of such Controlling Agreement will control.
[Signature Page Follows]
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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed and delivered by their respective representatives thereunto duly authorized as of the date first above written.
| SELLER: |
|---|
| ORCHESTRA<br> BIOMED HOLDINGS, INC. |
| By: |
| Name: |
| Title: |
| PLEDGORS<br> (solely with respect to Article 10): |
| ORCHESTRA<br> BIOMED, INC. |
| By: |
| Name: |
| Title: |
| BACKBEAT<br> MEDICAL, LLC. |
| By: |
| Name: |
| Title: |
| CALIBER<br> THERAPEUTICS, LLC. |
| By: |
| Name: |
| Title: |
[Signature Page to Revenue ParticipationRight Purchase and Sale Agreement]
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed and delivered by their respective representatives thereunto duly authorized as of the date first above written.
| BUYER: |
|---|
| LIGAND PHARMACEUTICALS, INC. |
| By: |
| Name: |
| Title: |
[Signature Page to Revenue ParticipationRight Purchase and Sale Agreement]
Exhibit 10.2
ExecutionVersion
STOCK PURCHASE AGREEMENT
This STOCK PURCHASE AGREEMENT (this “Agreement”) is dated as of July 31, 2025, by and between Orchestra BioMed Holdings, Inc., a Delaware corporation (the “Issuer”), and Ligand Pharmaceuticals Incorporated, a Delaware corporation (the “Investor”).
W I T N E S S E T H:
WHEREAS, the Issuer and the Investor are executing and delivering this Agreement in reliance upon the exemption from securities registration afforded by Section 4(a)(2) of the U.S. Securities Act of 1933, as amended (the “Securities Act”);
WHEREAS, the Investor, wishes to purchase, and the Issuer wishes to issue and sell, upon the terms and conditions stated in this Agreement, that number of shares of the Issuer’s common stock, par value $0.0001 per share (“Common Stock”), rounded down to the nearest whole share (the “Shares”), determined by dividing $5,000,000.00 by the price per share at which the Common Stock is sold to the public in the Issuer’s next underwritten public offering of its Common Stock pursuant to an effective registration statement under the Securities Act (the “Subsequent Offering”), as set forth on the cover page of the prospectus filed in connection with the Subsequent Offering, and such purchase will occur immediately following and shall be conditioned upon, the closing of the Subsequent Offering (the “Closing”);
WHEREAS, the Issuer has engaged Piper Sandler & Co. (“Piper Sandler”) and TD Securities (USA) LLC (“TD Cowen” and together with Piper Sandler, the “Placement Agents”) to act as placement agents in connection with the sale of Shares pursuant to this Agreement; and
WHEREAS, prior to the Closing, the parties hereto shall execute and deliver a Registration Rights Agreement, substantially in the form attached hereto as Exhibit A (the “Registration Rights Agreement,” and together with this Agreement, the “Transaction Agreements”), pursuant to which, among other things, the Issuer will agree to provide certain registration rights with respect to the Shares under the Securities Act and the rules and regulations promulgated thereunder and applicable state securities laws.
NOW THEREFORE, in consideration of the foregoing and the mutual agreements, covenants, provisions and warranties herein contained and for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:
Article I
PURCHASE AND SALE
1.1 Purchase and Sale of Shares. Subject to the (i) terms and conditions set forth in this Agreement and (ii) the receipt by the Issuer of gross proceeds of at least $30,000,000 in the aggregate pursuant to (a) the Subsequent Offering and (b) the terms of a stock purchase agreement between the Issuer and Covidien Group S.à.r.l., dated as of the date hereof (the “Covidien Private Placement”), at the Closing, the Issuer agrees to issue and sell to the Investor the Shares, and the Investor agrees to purchase the Shares at a price per share equal to the price at which the Common Stock is sold to the public in the Subsequent Offering, as set forth on the cover page of the prospectus filed in connection with the Subsequent Offering (the “Purchase Price”).
1.2 Closing. Subject to satisfaction or waiver of the conditions set forth in Article V of this Agreement, the Closing shall take place on the date of the closing of the Subsequent Offering at the offices of counsel to the Issuer, Paul Hastings LLP located at 200 Park Avenue, New York, New York 10166, or at such other place as the applicable parties to the Closing shall agree in writing.
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1.3 Deliveries at Closing.
(a) At the Closing, the Investor shall deliver to Issuer the following:
(i) the Purchase Price by wire transfer of immediately available funds to the account designated by the Issuer in writing; and
(ii) the Registration Rights Agreement, duly executed by the Investor.
(b) At the Closing, the Issuer shall deliver to the Investor the following:
(i) the instruments, consents, certificates and other documents required of the Issuer pursuant to Section 5.2;
(ii) the Shares in book entry form, free and clear of any liens or other restrictions whatsoever (other than those arising under applicable securities laws), registered in the name of Investor (or its nominee in accordance with its delivery instructions); and
(iii) the Registration Rights Agreement, duly executed by the Issuer.
Article II
REPRESENTATIONS AND WARRANTIES OF THE ISSUER
The Issuer represents and warrants to the Investor and the Placement Agents that the statements contained in this Article II are true and correct as of the date of this Agreement and as of the Closing (except for representations and warranties that speak as of a specific date, which shall be made as of such date):
2.1 Organization and Good Standing. The Issuer is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware, has the requisite power and authority to own, lease and operate its properties and to carry on its business as now conducted and described in the SEC Reports (as defined below) and is qualified to do business in each jurisdiction in which the character of its properties or the nature of its business requires such qualification.
2.2 Capitalization. The Issuer’s disclosure of its authorized, issued and outstanding capital stock in the SEC Reports containing such disclosure was accurate in all material respects as of the date indicated in such SEC Reports. All of the issued and outstanding shares of Common Stock have been duly authorized and validly issued and are fully paid and non-assessable. None of the outstanding shares of capital stock of the Issuer were issued in violation of any preemptive or other similar rights of any securityholder of the Issuer which have not been waived, and such shares were issued in compliance in all material respects with applicable state and federal securities law and any rights of third parties. Except as disclosed in the SEC Reports, there are no outstanding rights (including, without limitation, pre-emptive rights), warrants or options to acquire, or instruments convertible into or exchangeable for, any shares of capital stock or other equity interest in the Issuer or any of its subsidiaries, or any contract, commitment, agreement, understanding or arrangement of any kind relating to the issuance of any capital stock of the Issuer or any such subsidiary, any such convertible or exchangeable securities or any such rights, warrants or options; the capital stock of the Issuer conforms in all material respects to the description thereof contained in the SEC Reports; and all the outstanding shares of capital stock or other equity interests of each subsidiary owned, directly or indirectly, by the Issuer have been duly and validly authorized and issued, are fully paid and non-assessable (except, in the case of any foreign subsidiary, for directors’ qualifying shares) and are owned directly or indirectly by the Issuer, free and clear of any lien, charge, encumbrance, security interest, restriction on voting or transfer or any other claim of any third party.
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2.3 Authorization and Validity of Transaction Agreements. The Issuer has all requisite power and authority to execute and deliver the Transaction Agreements, to perform its obligations under the terms of the Transaction Agreements, including the issuance and sale of the Shares, and to consummate the transactions contemplated hereby. The execution and delivery of the Transaction Agreements, the performance by the Issuer of its obligations under the terms of the Transaction Agreements and the consummation of the transactions contemplated thereby, including the issuance and sale of the Shares, have been duly and validly authorized by all requisite corporate action of the Issuer, its officers, directors and stockholders (none of which actions have been modified or rescinded, and all of which actions are in full force and effect). This Agreement has been duly executed and delivered by the Issuer and, assuming the due authorization, execution and delivery by the Investor of this Agreement and that this Agreement constitutes the legal, valid and binding agreement of the Investor, constitutes a legal, valid and binding obligation of the Issuer, enforceable against the Issuer in accordance with its terms, except as such enforceability may be limited or otherwise affected by bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and/or similar laws relating to or affecting the rights of creditors generally or by general equity principles (regardless of whether such enforceability is considered in a proceeding in equity or at law).
2.4 Title to Shares. The Shares have been duly authorized and upon payment by the Investor of the Purchase Price and delivery by the Issuer of the Shares in “book-entry” form pursuant to the terms hereof, the Shares will be validly issued, fully paid and non-assessable, and the Investor will acquire good and marketable title thereto, free and clear of all mortgages, liens, pledges, charges, claims, security interests and other encumbrances (other than any restrictions created by the Investor or any restrictions created by federal or state securities laws), and shall be entitled to all rights accorded to a holder of Common Stock. The issuance and delivery of the Shares does not (a) obligate the Issuer to offer to issue, or issue, shares of Common Stock or other securities to any person pursuant to any preemptive rights, rights of first refusal, rights of participation or similar rights, or (b) result in any adjustment (automatic, at the election of any person or otherwise) of the exercise, conversion, exchange or reset price under, or any other anti-dilution adjustment pursuant to, any outstanding securities of the Issuer.
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2.5 Non-Contravention. The execution and delivery of the Transaction Agreements by the Issuer, the performance by the Issuer of its obligations hereunder and thereunder, and the consummation by the Issuer of the transactions contemplated hereby and thereby do not, and will not as of the Closing, conflict with, contravene, result in a violation or breach of or default under (with or without the giving of notice or the lapse of time, or both), permit any party to terminate, amend or accelerate the provisions of, or result in the imposition of any claim, lien, pledge, deed of trust, option, charge, security interest, hypothecation, encumbrance, right of first offer, voting trust, proxy, right of third parties or other restriction or limitation of any nature whatsoever (each, a “Lien”), or any obligation to create any Lien, upon any of the properties or assets of the Issuer under (i) any contract, agreement, indenture, letter of credit, mortgage, security agreement, pledge agreement, deed of trust, bond, note, guarantee, surety obligation, warranty, license, franchise, permit, power of attorney, lease, instrument or other agreement (each, a “Contract”) to which the Issuer is a party or by which any of its property or assets may be bound, except as would not, individually or in the aggregate, be reasonably expected to have a material adverse effect on the assets, business, results of operation or financial operations of the Issuer and its subsidiaries, taken as a whole, or prevents, impairs, delays or impedes the legal authority of the Issuer to enter into and timely perform in any material respect its obligations under this Agreement (a “Material Adverse Effect”) or (ii) any provision of the organizational documents of the Issuer.
2.6 Consents. Assuming the accuracy of the representations and warranties of the Investor set forth in Article III hereof, no consent, approval, authorization, filing with or order of or registration with, any court or governmental agency or body is required in connection with the authorization, execution or delivery by the Issuer of the Transaction Agreements, the issuance and sale of the Shares and the performance by the Issuer of its other obligations under the Transaction Agreements, except (a) as have been or will be obtained or made under the Securities Act or the Securities Exchange Act of 1934, as amended (the “Exchange Act”), (b) customary post-closing filings with the Securities and Exchange Commission (“SEC”) or pursuant to state securities laws in connection with the offer and sale of the Shares by the Issuer in the manner contemplated herein, which will be filed on a timely basis, (c) the filing of the registration statement required to be filed by the Registration Rights Agreement, (d) notices that may be required by the rules of the Nasdaq Global Market (“Nasdaq”) or (e) such that the failure of which to obtain would not have a Material Adverse Effect. All notices, consents, authorizations, orders, filings and registrations which the Issuer is required to deliver or obtain prior to the Closing pursuant to the preceding sentence have been obtained or made or will be delivered or obtained or effected, and shall remain in full force and effect, on or prior to the Closing.
2.7 Exemption from Registration; No Integration; No General Solicitation.
(a) Subject to the accuracy of the representations and warranties of the Investor, it is not necessary in connection with the offer, sale and delivery of the Shares to the Investor in the manner contemplated by this Agreement to register the Shares under the Securities Act.
(b) Neither the Issuer nor any affiliate (as defined in Rule 501(b) of Regulation D under the Securities Act) (“Affiliate”) of the Issuer has directly, or through any agent, (i) sold, offered for sale, solicited offers to buy or otherwise negotiated in respect of, any security (as defined in the Securities Act) which is or will be integrated with the sale of the Shares in a manner that would require the registration under the Securities Act of the Shares or (ii) offered, solicited offers to buy or sold the Shares by any form of general solicitation or general advertising (as those terms are used in Regulation D under the Securities Act) or in any manner involving a public offering within the meaning of Section 4(a)(2) of the Securities Act.
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2.8 SEC Filings. The Issuer has filed all forms, statements, certifications, reports and documents required to be filed by it with the SEC under Section 13, 14(a) and 15(d) of the Exchange Act for the one year preceding the date of this Agreement and is in compliance with General Instruction I.A.3 of Form S-3. 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 filed SEC Reports complied in all material respects with the applicable requirements of the Exchange Act, and, as of the time they were filed, none of the filed SEC Reports 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. There are no outstanding or unresolved comments from the SEC staff with respect to the SEC Reports. To the Issuer’s knowledge, none of the SEC Reports are the subject of an ongoing SEC review. The interactive data in eXtensible Business Reporting Language included in the SEC Reports fairly presents the information called for in all material respects and has been prepared in accordance with the SEC’s rules and guidelines applicable thereto. As used in this Agreement, “SEC Reports” means (a) the Issuer’s most recently filed Annual Report on Form 10-K and (b) all Quarterly Reports on Form 10-Q or Current Reports on Form 8-K filed or furnished (as applicable) by the Issuer following the end of the most recent fiscal year for which an Annual Report on Form 10-K has been filed and prior to the execution of this Agreement, together in each case with any documents incorporated by reference therein or exhibits thereto.
2.9 Absence of Litigation. There is no action, suit, proceeding, arbitration, claim, investigation, charge, complaint or inquiry pending or, to the Issuer’s knowledge, threatened against the Issuer or any of its subsidiaries which, individually or in the aggregate, has had or would reasonably be expected to have a Material Adverse Effect, nor are there any orders, writs, injunctions, judgments or decrees outstanding of any court or government agency or instrumentality and binding upon the Issuer or any of its subsidiaries that have had or would reasonably be expected to have a Material Adverse Effect.
2.10 Compliance with Law; Permits. Neither the Issuer nor any of its subsidiaries is in violation of, or has received any notices of violations with respect to, any laws, statutes, ordinances, rules or regulations of any governmental body, court or government agency or instrumentality, except for violations which, individually or in the aggregate, have not had and would not reasonably be expected to have a Material Adverse Effect. The Issuer and its subsidiaries have all required licenses, permits, certificates and other authorizations (collectively, “Governmental Authorizations”) from such federal, state or local government or governmental agency, department or body that are currently necessary for the operation of the business of the Issuer and its subsidiaries as currently conducted, except where the failure to possess currently such Governmental Authorizations has not had and is not reasonably expected to have a Material Adverse Effect. Neither the Issuer nor any subsidiary has received any written (or, to the Issuer’s knowledge, oral) notice regarding any revocation or material modification of any such Governmental Authorization, which, individually or in the aggregate, if the subject of an unfavorable decision, ruling or finding, has or would reasonably be expected to result in a Material Adverse Effect.
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2.11 Compliance with Nasdaq Continued Listing Requirements. The Issuer is in compliance with applicable Nasdaq continued listing requirements. There are no proceedings pending or threatened against the Issuer relating to the continued listing of the Issuer’s Common Stock on Nasdaq and the Issuer has not received any notice of, nor is there any reasonable basis for, the delisting of the Issuer’s Common Stock from Nasdaq.
2.12 Investment Company. The Issuer is not required to be registered as, and immediately following the Closing will not be required to register as, an “investment company” within the meaning of the Investment Company Act of 1940, as amended.
2.13 Brokers’ Fees. Other than fees payable to the Placement Agents pursuant to the terms of their agreement with the Issuer, dated July 31, 2025 (the “Engagement Letter”), there is no investment banker, broker, finder, financial advisor or other intermediary who has been retained by or is authorized to act on behalf of the Issuer who is entitled to any fee or commission from the Investor in connection with the Investor’s purchase of the Shares as contemplated by this Agreement. The Issuer has provided to the Investor a true, correct and complete copy of the Engagement Letter, which has not been amended or modified.
2.14 Covidien Private Placement. The shares of Common Stock to be purchased by Covidien Group S.à.r.l. in the Covidien Private Placement will be purchased at a price per share of Common Stock at least equal to the price at which the Common Stock is sold to the public in the Subsequent Offering, as set forth on the cover page of the prospectus filed in connection with the Subsequent Offering.
Article III
REPRESENTATIONS AND WARRANTIES OF THE INVESTOR
The Investor represents and warrants to the Issuer and the Placement Agents that the statements contained in this Article III are true and correct as of the date of this Agreement and as of the Closing:
3.1 Organization and Good Standing. The Investor is duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization.
3.2 Authorization and Validity of Transaction Agreements. The Investor has all requisite power and authority to execute and deliver the Transaction Agreements, to perform its obligations hereunder and thereunder and to consummate the transactions contemplated hereby and thereby. The execution and delivery of the Transaction Agreements, the performance by the Investor of its obligations hereunder and thereunder and the consummation of the transactions contemplated hereby and thereby have been duly and validly authorized by all requisite corporate action of the Investor. Assuming this Agreement constitutes the legal and binding agreement of the Issuer, this Agreement constitutes a legal, valid and binding obligation of the Investor, enforceable against the Investor in accordance with its terms, except as such enforceability may be limited or otherwise affected by bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and/or similar laws relating to or affecting the rights of creditors generally or by general equity principles (regardless of whether such enforceability is considered in a proceeding in equity or at law).
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3.3 Non-Contravention. The execution and delivery of the Transaction Agreements by the Investor, the performance by the Investor of its obligations hereunder and thereunder, and the consummation by the Investor of the transactions contemplated hereby and thereby do not, and will not as of the Closing, conflict with, contravene, result in a violation or breach of or default under (with or without the giving of notice or the lapse of time, or both), permit any party to terminate, amend or accelerate the provisions of, or result in the imposition of any Lien (or any obligation to create any Lien) upon any of the property or assets of the Investor under (i) any Contract to which the Investor is a party or by which any of its property or assets may be bound, except as would not, individually or in the aggregate, be reasonably expected to materially delay or hinder the ability of the Investor to perform its obligations under the Transaction Agreements or (ii) any provision of the organizational documents of the Investor.
3.4 Investment Purpose. The Shares to be acquired by the Investor pursuant to this Agreement are being acquired for investment for its own account and with no intention of distributing or reselling the Shares or any part thereof in any transaction that would be in violation of the securities laws of the United States or any state of the United States or any foreign jurisdiction. The Investor further agrees that it has not entered and prior to the Closing will not enter into any Contract with respect to the distribution, sale, transfer or delivery of the Shares.
3.5 Investment Experience; Access to Information. The Investor is sufficiently experienced in financial and business matters to be capable of evaluating the merits and risks involved in purchasing the Shares and to make an informed decision relating thereto and can bear the economic risk of its investment in the Shares. The Investor has carefully reviewed any disclosure documents (including the Transaction Agreements and the SEC Reports) used in connection with the sale of Shares pursuant to this Agreement. The Investor has had adequate opportunity to ask questions of, and receive answers from, the officers, employees, agents, accountants, and representatives of the Issuer concerning the business, operations, financial condition, assets, liabilities of the Issuer and all other matters relevant to its investment in the Shares. The Investor has not been organized solely for the purpose of acquiring the Shares.
3.6 Independent Investment Decision. The Investor understands that nothing in this Agreement or any other materials presented by or on behalf of the Issuer to the Investor in connection with the purchase of the Shares constitutes legal, tax or investment advice. The Investor has consulted such legal, tax and investment advisors as it, in such Investor’s sole discretion, has deemed necessary or appropriate in connection with its purchase of the Shares.
3.7 Restricted Shares.
(a) The Investor understands and hereby acknowledges that the Shares are “restricted securities” within the meaning of Rule 144 promulgated under the Securities Act and have not been registered under the Securities Act or any state securities law and may not be offered or sold except pursuant to registration or pursuant to an exemption from the registration requirements of the Securities Act and any applicable states securities laws. The Investor 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.
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(b) The Investor acknowledges and agrees that it has been advised to consult legal counsel prior to making any offer, resale, transfer, pledge or disposition of any of the Shares.
(c) The Investor acknowledges that no federal or state agency has passed upon or endorsed the merits of the offering of the Shares or made any findings or determination as to the fairness of this investment.
(d) The Investor understands and hereby acknowledges that the Shares, and any securities issued in respect of or in exchange for the Shares, will bear a legend in substantially the following form:
THE SHARES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, (“THE SECURITIES ACT”) OR APPLICABLE STATE LAWS, AND MAY NOT BE OFFERED, SOLD, ASSIGNED, PLEDGED, TRANSFERRED OR OTHERWISE DISPOSED OF IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR PURSUANT TO AN AVAILABLE EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT.
3.8 Qualified Institutional Buyer; Accredited Investor. The Investor is a “qualified institutional buyer” (as defined in Rule 144A under the Securities Act) or an institutional “accredited investor” as that term is defined in Rule 501(a) under Regulation D promulgated pursuant to the Securities Act. The Investor further represents and warrants that (x) it is capable of evaluating the merits and risk of such investment and (y) that it has not been organized for the purpose of acquiring the Shares and is an “institutional account” as defined by FINRA Rule 4512(c). The Investor is aware that the Issuer is relying upon the representations, warranties and agreements contained in this Agreement for the purpose of determining whether this transaction meets the requirements of the exemption from the registration requirements of the Securities Act and any applicable state laws.
3.9 Non-Solicitation. The Investor acknowledges and agrees that the Investor is purchasing the Shares directly from the Issuer. Investor became aware of this offering of the Shares directly from the Issuer as a result of a pre-existing, substantive relationship with the Issuer, and/or its advisors (including, without limitation, attorneys, accountants, bankers, consultants and financial advisors), agents, control persons, representatives, Affiliates, directors, officers, managers, members, and/or employees, and/or the representatives of such persons. The Shares were offered to Investor solely by direct contact between Investor and the Issuer and/or its representatives. Investor did not become aware of this offering of the Shares, nor were the Shares offered to Investor, by any other means, and neither the Issuer and/or its representatives acted as investment advisor, broker or dealer to Investor. The Investor is not purchasing the Shares as a result of any general or public solicitation or general advertising, or publicly disseminated advertisement, article, notice or other communication regarding the Shares published in any newspaper, magazine or similar media or broadcast over television, radio or the internet or presented at any seminar or any other general solicitation or general advertisement, including any of the methods described in Section 502(c) of Regulation D under the Securities Act.
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3.10 Certain Trading Activities. Other than consummating the transaction contemplated hereby, the Investor has not, nor has any Person acting on behalf of or pursuant to any understanding with the Investor, directly or indirectly executed any purchases or sales, including a “short sale,” as such term is defined Rule 200 of Regulation SHO under the Exchange Act, of the securities of the Issuer during the period commencing as of the time that the Investor was first contacted by the Issuer or any other Person regarding the transaction contemplated hereby and ending immediately prior to the date of this Agreement. The Investor has maintained the confidentiality of all disclosures made to it in connection with this transaction (including the existence and terms of this transaction), other than disclosures made to its advisors and agents who have a need to know such information.
3.11 Placement Agents. The Investor hereby acknowledges and agrees for the express benefit of the Placement Agents that (a) the Placement Agents have not made and will not make any representation or warranty, whether express or implied, of any kind or character, or provide any advice or recommendation in connection with the execution, delivery and performance of the Transaction Agreements, and (b) the Placement Agents will not have any responsibility with respect to any information, certificates or documentation delivered by or on behalf of the Issuer pursuant to this Agreement, including (i) any representations, warranties or agreements made by any person or entity under or in connection with the execution, delivery and performance of the Transaction Agreements, or the execution, legality, validity or enforceability (with respect to any person) thereof, (ii) the business, affairs, financial condition, operations, properties or prospects of, or any other matter concerning the Issuer, or (iii) any valuation, offering or marketing materials, or any omissions from such materials.
3.12 No Liability of Placement Agents to the Investor. The Investor agrees that none of the Placement Agents, any of their Affiliates or any of their officers, directors or employees shall be liable to the Investor in connection with its purchase of the Shares.
Article IV
COVENANTS
4.1 Registration Rights. Subject to the occurrence of the Closing, each of the parties hereto covenants to enter into the Registration Rights Agreement with respect to the Shares.
4.2 Listing. The Issuer shall use commercially reasonable efforts to maintain the listing and trading of its Common Stock on Nasdaq and, in accordance therewith, will use reasonable best efforts to comply in all material respects with the Issuer’s reporting, filing and other obligations under the rules and regulations of Nasdaq.
4.3 Integration; Aggregation. The Issuer shall not, and shall use its commercially reasonable efforts to ensure that no Affiliate of the Issuer shall, sell, offer for sale or solicit offers to buy or otherwise negotiate in respect of any security (as defined in Section 2 of the Securities Act) that will be integrated with the offer or sale of the Shares in a manner that would require the registration under the Securities Act of the sale of the Shares to the Investor, or that will be aggregated with the offer or sale of the Shares for purposes of the rules and regulations of Nasdaq such that it would require stockholder approval prior to the closing of such other transaction unless stockholder approval is obtained before the closing of such subsequent transaction.
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4.4 Removal of Legends.
(a) In connection with any sale, assignment, transfer or other disposition of the Shares by the Investor pursuant to Rule 144 or pursuant to any other exemption under the Securities Act such that the purchaser acquires freely tradable shares and upon compliance by the Investor with the requirements of this Agreement, if requested by the Investor by notice to the Issuer, the Issuer shall request the transfer agent of its Common Stock to remove any restrictive legends related to the book entry account holding such shares and make a new, unlegended entry for such book entry shares sold or disposed of without restrictive legends as soon as reasonably practicable following any such request therefor from the Investor, provided that the Issuer has timely received from the Investor customary representations and other documentation reasonably acceptable to the Issuer in connection therewith. The Issuer shall be responsible for the fees of its transfer agent and its legal counsel associated with such legend removal.
(b) Anytime following the six month anniversary of the issuance of the Shares and provided that the Investor is not an Affiliate of the Issuer at such time, the Issuer shall as soon as reasonably practicable following receipt of a duly completed and executed Legend Removal Certificate from the Investor substantially in the form attached hereto as Exhibit B, (A) deliver to the transfer agent instructions that the transfer agent shall make a new, unlegended entry for such book entry shares, and (B) cause its counsel to deliver to the transfer agent one or more opinions to the effect that the removal of such legends in such circumstances may be effected under the Securities Act if required by the transfer agent to effect the removal of the legend in accordance with the provisions of this Agreement.
4.5 Fees and Commissions. The Issuer shall be solely responsible for the payment of any placement agent’s fees, financial advisory fees, or broker’s commissions (other than for persons engaged by the Investor) relating to or arising out of the transactions contemplated hereby.
4.6 Indemnification.
(a) The Issuer agrees to indemnify and hold harmless the Investor and its directors, officers, trustees, members, managers, employees and agents (collectively, the “Indemnified Persons”), from and against any and all losses, claims, damages, liabilities and expenses (including without limitation reasonable and documented attorney fees and disbursements and other documented out-of-pocket expenses reasonably incurred in connection with investigating, preparing or defending any action, claim or proceeding, pending or threatened and the costs of enforcement thereof) to which such Person may become subject as a result of any breach of representation, warranty, covenant or agreement made by or to be performed on the part of the Issuer under the Transaction Agreements, and will reimburse any such Person for all such amounts as they are incurred by such Person solely to the extent such amounts have been finally judicially determined not to have resulted from such Person’s fraud or willful misconduct.
(b) Any person entitled to indemnification hereunder shall (i) give prompt written notice to the indemnifying party of any claim with respect to which it seeks indemnification and (ii) permit such indemnifying party to assume the defense of such claim with counsel reasonably satisfactory to the indemnified party; provided that any person entitled to indemnification hereunder shall have the right to employ separate counsel and to participate in the defense of such claim, but the fees and expenses of such counsel shall be at the expense of such person unless (a) the indemnifying party has agreed in writing to pay such fees or expenses, (b) the indemnifying party shall have failed to assume the defense of such claim and employ counsel reasonably satisfactory to such person or (c) in the reasonable judgment of any such person, based upon written advice of its counsel, a conflict of interest exists between such person and the indemnifying party with respect to such claims (in which case, if the person notifies the indemnifying party in writing that such person elects to employ separate counsel at the expense of the indemnifying party, the indemnifying party shall not have the right to assume the defense of such claim on behalf of such person); and provided, further, that the failure of any indemnified party to give written notice as provided herein shall not relieve the indemnifying party of its obligations hereunder, except to the extent that such failure to give notice shall materially adversely affect the indemnifying party in the defense of any such claim or litigation. It is understood that the indemnifying party shall not, in connection with any proceeding in the same jurisdiction, be liable for fees or expenses of more than one separate firm of attorneys at any time for all such indemnified parties. No indemnifying party will, except with the consent of the indemnified party, which consent shall not be unreasonably withheld, conditioned or delayed, consent to entry of any judgment or enter into any settlement unless such judgment or settlement (i) imposes no liability or obligation on, (ii) includes as an unconditional term thereof the giving of a complete, explicit and unconditional release from the party bringing such indemnified claims of all liability of the indemnified party in respect of such claim or litigation in favor of, and (iii) does not include any admission of fault, culpability, wrongdoing, or wrongdoing or malfeasance by or on behalf of, the indemnified party. No indemnified party will, except with the consent of the indemnifying party, which consent shall not be unreasonably withheld, conditioned or delayed, consent to entry of any judgment or enter into any settlement.
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(c) As used herein, “Person” means an individual, partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or any other entity or organization.
4.7 Further Assurances. Each party hereto shall execute and deliver such instruments and take such other actions prior to or after the Closing as any other party may reasonably request in order to carry out the intent of this Agreement, including without limitation obtaining any required consents or approvals from third parties. The Investor acknowledges that the Issuer will rely on the acknowledgments, understandings, agreements, representations and warranties contained in this Agreement. Prior to the Closing, the Investor agrees to promptly notify the Issuer if any of the acknowledgments, understandings, agreements, representations and warranties set forth in Article III of this Agreement are no longer accurate.
Article V
CONDITIONS PRECEDENT TO THE OBLIGATIONS
5.1 Mutual Conditions. The obligations of the Issuer and the Investor to consummate the purchase and sale of the Shares contemplated hereby are subject to the following conditions: (i) the occurrence of the closing of the Subsequent Offering and the simultaneous closing of the Covidien Private Placement resulting in the receipt by the Issuer of gross proceeds of at least $30,000,000 in the aggregate, (ii) the absence of any order, decree, judgment or injunction of a court of competent jurisdiction or other governmental or regulatory authority precluding the consummation of the purchase and sale of the Shares contemplated hereby and (iii) there shall not have been any action taken or any statute, rule or regulation enacted, promulgated or deemed applicable to, the purchase and sale of the Shares contemplated hereby by any court, governmental agency or regulatory or administrative authority that makes consummation of such transactions illegal.
5.2 Conditions to the Obligations of the Investor. The obligations of the Investor under this Agreement to consummate the purchase and sale of the Shares contemplated hereby are subject to the fulfillment (or waiver by the Investor) of the following conditions precedent:
(a) Representation and Warranties. The representations and warranties of the Issuer contained herein shall be true and correct in all material respects, except for those representation and warranties qualified by materiality or Material Adverse Effect, which shall be true and correct in all respects, as of the date of this Agreement and as of the Closing, as though made on and as of such date.
(b) Performance. The Issuer shall have performed in all material respects the obligations and conditions herein required to be performed or observed by the Issuer on or prior to the Closing.
(c) Consents. The Issuer shall have obtained any and all consents, permits, approvals, registrations and waivers necessary for the consummation of the purchase and sale of the Shares, all of which shall be in full force and effect.
(d) Adverse Changes. Since the date of this Agreement, no event or series of events shall have occurred that has had or would reasonably be expected to have a Material Adverse Effect.
(e) Opinion of Issuer Counsel. The Issuer shall have delivered to the Investor the opinion of Paul Hastings LLP, dated as of the Closing, in customary form and substance to be reasonably agreed upon with the Investor and addressing such legal matters as the Investor and the Issuer reasonably agree.
(f) Compliance Certificate. An authorized officer of the Issuer shall have delivered to the Investor at the Closing a certificate certifying that the conditions specified in Sections 5.2(a), (b), (c), (d) and (h) of this Agreement have been fulfilled.
(g) Secretary’s Certificate. The Secretary of the Issuer shall have delivered to the Investor at the Closing a certificate certifying (i) the Issuer’s certificate of incorporation; (ii) the Issuer’s bylaws; and (iii) resolutions of the Issuer’s Board of Directors (or an authorized committee thereof) approving this Agreement, the Registration Rights Agreement, the transactions contemplated by this Agreement and the issuance of the Shares.
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(h) Listing Requirements. No stop order or suspension of trading shall have been imposed by Nasdaq, the SEC or any other governmental or regulatory body with respect to public trading in the Common Stock. The Common Stock shall be listed on Nasdaq and shall not have been suspended, as of the Closing, by the SEC or Nasdaq from trading thereon nor shall suspension by the SEC or Nasdaq have been threatened, as of the Closing, in writing by the SEC or Nasdaq; and the Issuer shall have filed with Nasdaq a Notification Form: Listing of Additional Shares for the listing of the Shares and Nasdaq shall have raised no objection to such notice and the transactions contemplated hereby.
5.3 Conditions to the Obligations of the Issuer. The obligations of the Issuer under this Agreement to consummate the purchase and sale of the Shares contemplated hereby are subject to the fulfillment (or waiver in writing by the Issuer) of the conditions that (i) all representations and warranties of the Investor shall be deemed to have been made again at and as of the Closing and shall then be true and accurate and (ii) the Investor shall have performed and complied in all material respects with all agreements required by this Agreement to be performed or complied with by it prior to or at the Closing.
Article VI
MISCELLANEOUS
6.1 Termination. This Agreement may be terminated by mutual written consent of the Issuer and the Investor. In addition, this Agreement shall terminate prior to the consummation of the transactions contemplated hereby, if the closings of the Subsequent Offering and the Covidien Private Placement resulting in the receipt by the Issuer of aggregate gross proceeds of at least $30,000,000 do not occur prior to August 15, 2025. In the event of any termination of this Agreement, this Agreement shall become void and have no effect, without any liability to any person in respect hereof on the part of any party hereto, except for any liability resulting from such party’s breach of this Agreement prior to such termination.
6.2 Survival. Each of the representations and warranties contained in this Agreement shall survive indefinitely. Each of the covenants contained in this Agreement shall survive the Closing until performed in accordance with their terms.
6.3 Assignment; Successors and Assigns. This Agreement and the rights granted hereunder may not be assigned by either party without the prior written consent of the other party. This Agreement shall be binding upon and inure to the benefit of the parties hereto and their successors and permitted assigns as provided in this Agreement.
6.4 Third Party Beneficiaries. Nothing in this Agreement, express or implied, is intended to confer upon any person, other than the parties hereto or their respective successors and permitted assigns, any rights, remedies, obligations or liabilities under or by any reason of this Agreement, except as expressly provided in this Agreement.
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6.5 Amendments. The provisions of this Agreement may not be amended or modified except by a writing signed by each of the parties.
6.6 Governing Law. THIS AGREEMENT AND THE RIGHTS AND OBLIGATIONS OF THE PARTIES UNDER THIS AGREEMENT SHALL BE GOVERNED BY, AND CONSTRUED AND INTERPRETED IN ACCORDANCE WITH, THE LAW OF THE STATE OF NEW YORK, WITHOUT REGARD TO PRINCIPLES OF CONFLICTS OF LAW. EACH OF THE PARTIES HERETO IRREVOCABLY AND UNCONDITIONALLY SUBMITS TO THE EXCLUSIVE JURISDICTION OF THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK OR, IF SUCH COURT WILL NOT ACCEPT JURISDICTION, THE SUPREME COURT OF THE STATE OF NEW YORK OR ANY COURT OF COMPETENT CIVIL JURISDICTION SITTING IN NEW YORK COUNTY, NEW YORK FOR THE PURPOSE OF ANY ACTION OR JUDGMENT RELATING TO OR ARISING OUT OF THIS AGREEMENT OR ANY OF THE TRANSACTIONS CONTEMPLATED HEREBY AND TO THE LAYING OF VENUE IN SUCH COURT. EACH OF THE PARTIES HEREBY WAIVES THE DEFENSE OF AN INCONVENIENT FORUM TO THE MAINTENANCE OF ANY SUCH ACTION OR PROCEEDING IN SAID COURTS.
6.7 Waiver of Trial By Jury. TO THE EXTENT PERMITTED BY APPLICABLE LAW, EACH PARTY HERETO IRREVOCABLY WAIVES ALL RIGHT OF TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM, ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR ANY MATTER ARISING HEREUNDER.
6.8 Waivers; Remedies. No failure or delay on the part of any party in exercising any right, privilege, power or remedy under this Agreement, and no course of dealing shall (a) impair such right, power or remedy or (b) operate as a waiver thereof. No waiver shall be asserted against any party unless signed in writing by such party. The single or partial exercise of any right, power or remedy provided by law or under this Agreement shall not preclude any other or further exercise of any other right, power or remedy. The rights, powers and remedies provided in this Agreement are cumulative and not exclusive of any rights, powers and remedies provided by law.
6.9 Notices.
(a) All notices, requests, demands, waivers and other communications to be given by either party hereunder shall be in writing and shall be (i) mailed by first-class, registered or certified mail, postage prepaid, (ii) sent by hand delivery or reputable overnight delivery service or (iii) sent by electronic mail to the following address:
If to the Issuer:
Orchestra BioMed Holdings, Inc.
150 Union Square Drive
New Hope, Pennsylvania 18938
Attention: Chief Financial Officer
Email: [Omitted Pursuant to Item 601(a)(6)]
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with a copy (which shall not constitute notice) to:
Paul Hastings LLP
200 Park Avenue
New York, New York 10166
Attention: Yariv Katz
Email: [Omitted Pursuant to Item 601(a)(6)]
If to the Investor:
Ligand Pharmaceuticals Incorporated
555 Heritage Drive, Suite 200
Jupiter, Florida 33458
Attention: Paul Hadden; Andrew Reardon
Email: [Omitted Pursuant to Item 601(a)(6)]
with a copy (which shall not constitute notice) to:
Ropes & Gray LLP
Prudential Tower
800 Boylston Street
Boston, MA 02199
Attention: Ray Grant
Email: [Omitted Pursuant to Item 601(a)(6)]
or such other address as may be specified in writing to the other party hereto.
(b) All such notices, requests, demands, waivers and other communications shall be deemed to have been given and received (i) if by personal delivery or electronic mail, on the day of such delivery, (ii) if by first-class, registered or certified mail, on the fifth business day after the mailing thereof or (iii) if by reputable overnight delivery service, on the day delivered.
6.10 Execution in Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be deemed an original, but all such counterparts shall together constitute but one and the same instrument. Electronic signatures complying with the New York Electronic Signatures and Records Act (N.Y. State Tech. §§ 301-309), as amended from time to time, or other applicable law will be deemed original signatures for purposes of this Agreement. Transmission by telecopy, electronic mail or other transmission method of an executed counterpart of this Agreement will constitute due and sufficient delivery of such counterpart.
6.11 Headings. The Article and Section headings contained herein are for the convenience of the parties only and shall not affect the construction or interpretation of this Agreement.
6.12 Severability. Each provision of this Agreement shall be considered severable and if for any reason any provision or provisions herein are determined to be invalid, unenforceable or illegal under any existing or future law, such invalidity, unenforceability or illegality shall not impair the operation of or affect those portions of this Agreement which are valid, enforceable and legal.
6.13 Entire Agreement. This Agreement, including the exhibits hereto, contains the entire understanding of the parties with respect to the subject matter hereof, and supersedes all prior agreements and understandings, both written and oral, among the parties with respect to the subject matter hereof.
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IN WITNESS WHEREOF, the parties have executed and delivered this Agreement as of the date first written above.
| ISSUER: | |
|---|---|
| Orchestra<br> BioMed Holdings, Inc. | |
| By: | /s/ David P. Hochman |
| Name: David P. Hochman | |
| Title: Chief Executive Officer | |
| INVESTOR: | |
| Ligand<br> Pharmaceuticals Incorporated | |
| By: | /s/ Todd C. Davis |
| Name: Todd C. Davis | |
| Title: Chief Executive Officer |
Exhibit A
Form ofREGISTRATION RIGHTS Agreement
Exhibit B
LEGEND REMOVAL CERTIFICATE
Exhibit 10.3
EXECUTION VERSION
LOAN AGREEMENT
THIS LOAN AGREEMENT (this “Agreement”) dated as of July 31, 2025, is by and among ORCHESTRA BIOMED HOLDINGS, INC., a Delaware corporation (“Parent”), ORCHESTRA BIOMED, INC., a Delaware corporation (“Orchestra”), Caliber Therapeutics, LLC, a Delaware limited liability company (“Caliber”), and BACKBEAT MEDICAL, LLC, a Delaware limited liability company (“Backbeat,” and collectively with Parent, Orchestra, and Caliber, the “Borrower” or, as the context may require, the “Borrowers”), and MEDTRONIC, INC., a Minnesota corporation (the “Lender”).
RECITALS:
WHEREAS, concurrently with the execution of this Agreement, Parent and Lender shall enter into that certain Stock Purchase Agreement, pursuant to which, among other things, Lender shall purchase from Parent, and Parent shall sell and issue to Lender, certain shares of common stock of the Parent, on the terms and subject to the conditions set forth therein; and
WHEREAS, Borrower has requested the Lender extend a loan in the aggregate original principal amount of TWENTY MILLION DOLLARS ($20,000,000.00) (the “Loan”) and the Lender is willing and prepared to extend such Loan to Borrower upon the terms and subject to the conditions hereinafter set forth.
AGREEMENTS:
IN CONSIDERATION of the foregoing premises, and the mutual covenants set forth herein, the parties agree as follows:
Article 1
DEFINITIONS
Section 1.1 DefinedTerms. In addition to the terms defined elsewhere in this Agreement, the following terms shall have the meanings set out respectively after each (and such meanings shall be equally applicable to both the singular and plural form of the terms defined, as the context may require):
“Act of Bankruptcy”: With respect to any Person under any applicable law, if (i) the Person shall (1) apply for or consent to the appointment of, or the taking of possession by, a receiver, custodian, trustee, liquidator or the like of the Person or of all or a substantial part of the Person’s property, (2) commence a voluntary case under any bankruptcy, insolvency, reorganization, arrangement, readjustment of debt, dissolution, liquidation or similar proceeding under the laws of any jurisdiction, (3) file a petition seeking to take advantage of any other law relating to bankruptcy, insolvency, reorganization, winding up or composition or adjustment of debts, (4) admit, through an officer of such Person in writing to the other party or any third party, an inability to pay its debts as they mature, (5) make an assignment for the benefit of the Person’s creditors; or (ii) a proceeding or case shall be commenced, without the application or consent of the Person, in any court of competent jurisdiction, and such proceeding or case shall not be dismissed within 60 days after commencement, seeking (1) the liquidation, reorganization, dissolution, winding up or the composition or adjustment of debts of the Person, (2) the appointment of a trustee, receiver, custodian or liquidator or the like of the Person or of all or a substantial part of the Person’s property, or (3) similar relief in respect of the Person under any law relating to bankruptcy, insolvency, reorganization, winding up or composition or adjustment of debts.
“Affiliate”: Any Person (i) which directly or indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with, any Person or any of such Person’s Subsidiaries or (ii) 20% or more of the equity interest of which is held beneficially or of record by any Person or any of such Person’s Subsidiaries. Control for purposes of this definition means the possession, directly or indirectly, of the power to cause the direction of management and policies of a Person, whether through the ownership of voting securities or otherwise.
“Bankruptcy Code”: The federal bankruptcy law of the United States as from time to time in effect, currently as Title 11 of the United States Code. Section references to current sections of the Bankruptcy Code shall refer to comparable sections of any revised version thereof if section numbering is changed.
“Borrower Products”: All products, software, service offerings, technical data or technology currently being designed, manufactured or sold or that are under clinical investigation or development by Borrower or any of its Subsidiaries or which Borrower or any of its Subsidiaries intends to sell, license, or distribute in the future including any products or service offerings under development, collectively, together with all products, software, service offerings, technical data or technology that have been sold, licensed or distributed by Borrower since its formation. Without limiting the foregoing, Borrower Products shall include Borrower’s atrioventricular interval modulation bioelectronic therapy candidate.
“Borrower Representative”: As defined in Section 11.16.
“Business Day”: Any day (other than a Saturday, Sunday or legal holiday in the State of Minnesota or the State of New York) on which banks are permitted to be open in Minneapolis, Minnesota and New York, New York.
“Capitalized Lease”: Any lease which is or should be capitalized on the books of the lessee in accordance with GAAP.
“Change of Control”: With respect to the Borrower, the occurrence of any of the following, and in the case of subsection (i), (ii), or (iii), where the acquirer(s) is any Person other than the Lender or any Affiliate of the Lender:
(i) a sale of all or substantially all of the assets of the Borrower (in a single transaction or in a series of related transactions);
(ii) a merger or consolidation involving the Borrower or any subsidiary of the Borrower after the completion of which: (A) in the case of a merger (other than a triangular merger) or a consolidation involving the Borrower, the stockholders of Borrower immediately prior to the completion of such merger or consolidation beneficially own (within the meaning of Rule 13d-3 promulgated under the Exchange Act or comparable successor rules), directly or indirectly, outstanding voting securities representing equal to or less than 50% of the combined voting power of the surviving entity in such merger or consolidation, and (B) in the case of a triangular merger involving the Borrower or a subsidiary of the Borrower, the stockholders of the Borrower immediately prior to the completion of such merger beneficially own (within the meaning of Rule 13d-3 promulgated under the Exchange Act, or comparable successor rules), directly or indirectly, outstanding voting securities representing equal to or less than 50% of the combined voting power of the surviving entity in such merger and equal to or less than 50% of the combined voting power of the parent of the surviving entity in such merger;
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(iii) an acquisition by any person, entity or “group” (within the meaning of Section 13(d) or 14(d) of the Exchange Act or any comparable successor provisions), other than any employee benefit plan, or related trust, sponsored or maintained by the Borrower or an Affiliate of the Borrower and other than in a merger or consolidation of the type referred to in clause “(ii)” above, of beneficial ownership (within the meaning of Rule 13d-3 promulgated under the Exchange Act, or comparable successor rules) of outstanding voting securities of the Borrower representing 50% or more of the combined voting power of the Borrower (in a single transaction or series of related transactions); and
(iv) the grant by the Borrower to any party other than the Lender or an Affiliate of the Lender of an exclusive license to all or substantially all of the Borrower’s Intellectual Property that is used to generate all or substantially all of the Borrower’s revenues.
“Clinical Trial”: The ongoing pivotal study known as “BradycArdia paCemaker With AV Interval Modulation for Blood prEssure treAtmenT” sponsored by Borrower and identified as NCT06059638.
“Closing”: As defined in Section 2.2.
“Closing Date”: As defined in Section 2.2.
“Collateral”: As defined in Section 12.1.
“Commercialization”: Any and all activities directed to the distribution, marketing, detailing, promotion selling and securing of reimbursement of the Products worldwide (including the using, importing, selling and offering for sale of the Products), and shall include post-Marketing Approval studies to the extent required by a Regulatory Authority, post-launch marketing, promoting, detailing, distributing, selling the Products, importing, exporting or transporting the Products for sale, and regulatory compliance with respect to the foregoing. When used as a verb, “Commercialize” means to engage in Commercialization. Except with respect to post-Marketing Approval studies required by a Regulatory Authority, Commercialization shall not include any activities directed to the research or development (including pre-clinical and clinical development) or manufacture of the Products.
“Copyright License”: Any written agreement granting any right to use any Copyright or Copyright registration, now owned or hereafter acquired by Borrower or in which Borrower now holds or hereafter acquires any interest.
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“Copyrights”: All copyrights, whether registered or unregistered, held pursuant to the laws of the United States of America, any State thereof, or of any other country.
“Credit Party”: The Borrower, any Subsidiary of the Borrower, any Person who at any time guaranties or pledges any assets to secure the Obligations, or any one or more of them.
“Default”: Any event which, with the giving of notice to the Borrower or lapse of time, or both, would constitute an Event of Default.
“Default Rate”: The Interest Rate plus 2.0%.
“Distributors”: A Third Party that (a) purchases or has the option to purchase any Product in finished form from or at the direction of Parent or any of its Affiliates, (b) has the right, option or obligation to distribute, market and sell the Products (with or without packaging rights) in one or more regions, and (c) does not otherwise make any royalty, milestone, profit share or other similar payment to Parent or its Affiliate based on such Third Party’s sale of the Products. The term “packaging rights” in this definition will mean the right for the Distributor to package or have packaged Products supplied in unpackaged bulk form into individual ready-for-sale packs. For the purposes of this Agreement, neither Terumo Medical Corporation nor its Affiliates shall be deemed to be a Distributor with respect to the Terumo Agreement.
“Dollar(s)” or “$”: Lawful dollars of the United States of America.
“EMA”: The European Medicines Agency, or any successor agency thereto.
“Event of Default”: Any event described in Section 9.1.
“Exchange Act”: The U.S. Securities Exchange Act of 1934, as amended, and all of the rules and regulations promulgated thereunder.
“FDA”: The U.S. Food and Drug Administration, and any successor agency thereto.
“FDCA”: The U.S. Food, Drug and Cosmetic Act (including the rules and regulations of the FDA promulgated thereunder).
“Force Majeure”: Any act of God, war, riot, act of terrorism, embargo, governmental rule, regulation or decree, flood, fire, hurricane or other casualty, earthquake, strike, lockout, or other labor disturbance, the unavailability of labor or materials, or any other events or circumstances not within the reasonable control of the Person affected, whether similar or dissimilar to any of the foregoing.
“Fraudulent Conveyance”: As defined in Section 11.14.
“Funding Date”: The first Business Day that is 270 days after August 4, 2025.
“GAAP”: Generally accepted accounting principles as in effect from time to time in the United States of America, consistently applied.
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“Governmental Authority”: 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.
“In-Licenses”: Any material license, settlement agreement or other material agreement or arrangement between Parent or any of its Affiliates and any Third Party pursuant to which Parent or any of its Affiliates obtains a license or a covenant not to sue or similar grant of rights to any Patents or other material intellectual property rights of such Third Party that is necessary for, or used in, the development, manufacture, use or Commercialization of a Product worldwide. For the avoidance of doubt, the parties agree that ordinary course, non-exclusive agreements, such as reagent agreements, software agreements and clinical trial agreements are not a “material license, settlement agreement or other material agreement or arrangement” for the purposes of this definition.
“Indebtedness”: Without duplication, (a) all indebtedness for borrowed money or credit extended to or for the account of the Borrower or any Subsidiary, including without limitation, (i) obligations secured by any mortgage, pledge, security interest, lien, charge or other encumbrance existing on property owned or acquired subject thereto, whether or not the obligation secured thereby shall have been assumed and whether or not the obligation secured is the obligation of the owner or another party; (ii) any obligation on account of deposits or advances; (iii) any obligation for the deferred purchase price of any property or services; (iv) any obligation as lessee under any Capitalized Lease; (v) all guaranties, endorsements and other contingent obligations respecting Indebtedness of others; and (vi) undertakings or agreements to reimburse or indemnify issuers of letters of credit; (b) all obligations under any foreign exchange contract, currency swap agreement, interest rate swap, cap or collar agreement or similar agreement or arrangement designed to alter the risks arising from fluctuations in currency values or interest rates; and (c) all obligations under commodity purchase or option agreements or other commodity price hedging arrangements. For all purposes of this Agreement (x) the Indebtedness of any Person shall include the Indebtedness of any partnership in which such Person is a general partner, and (y) the Indebtedness of any Person shall include the Indebtedness of any joint venture in which such Person is a joint venturer.
“Indemnified Person”: As defined in Section 11.4.
“Intellectual Property”: All of Borrower’s Copyrights; Trademarks; Patents; Licenses; trade secrets and inventions; mask works; Borrower’s applications therefor and reissues, extensions, or renewals thereof; and Borrower’s goodwill associated with any of the foregoing, together with Borrower’s rights to sue for past, present and future infringement of Intellectual Property and the goodwill associated therewith.
“Intellectual Property Rights”: Any and all of the following as they exist worldwide in respect of the applicable Product at any time: (a) the Patent Rights, (b) the Know-How Rights, (c) the Trademark Rights, and (d) any and all other material intellectual property rights or proprietary rights, in each case of clauses (a)-(d), owned or in-licensed by the Parent or any of its Affiliates or under which the Parent or any of its Affiliates is or may become empowered to grant licenses, in each case of clauses (a)-(d), that are necessary or used in the development, manufacture, use, or Commercialization of the Products worldwide.
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“Interest Rate”: The annual rate of interest that shall at all times be equal to 11.00%.
“Investment”: The acquisition, purchase, making or holding of any stock or other security, any loan, advance, contribution to capital, extension of credit (except for trade and customer accounts receivable for inventory sold or services rendered in the ordinary course of business and payable in accordance with customary trade terms), any acquisitions of real or personal property (other than real or personal property acquired in the ordinary course of business) and any purchase of stock or other debt or equity securities of or any interest in another Person or any integral part of any business or all or substantially all of the assets comprising such business or part thereof.
“Know-How”: Any and all proprietary and confidential information, know-how and trade secrets, including processes, formulae, models and techniques (including rights in algorithms, data, databases, data collections, and software).
“Know-How Rights”: Any and all material Know-How owned or in-licensed by Parent or any of its Affiliates or under which Parent or any of its Affiliates is or may become empowered to grant licenses (including, for the avoidance of doubt, material Know-How related to Improvements), in each case, that are necessary or used in the development, manufacture, use, or Commercialization of the Products.
“Knowledge”: The actual knowledge, after due inquiry, of the Borrower.
“License”: Any Copyright License, Patent License, Trademark License or other Intellectual Property license of rights or interests.
“License Agreement”: Has the meaning set forth in Appendix A to the Note.
“Ligand”: Ligand Pharmaceuticals, Inc., a Delaware corporation.
“Ligand Obligations”: The obligations of the Borrower under the Revenue Interest Agreement.
“Lien”: Any security interest, mortgage, pledge, lien, hypothecation, judgment lien or similar legal process, charge, encumbrance, title retention agreement or analogous instrument or device (including, without limitation, the interest of the lessors under Capitalized Leases and the interest of a vendor under any conditional sale or other title retention agreement).
“Ligand Intercreditor Agreement”: The Pari Passu Intercreditor Agreement, dated as of the date hereof, between Lender and Ligand.
“Loan”: Has the meaning set forth in the Recitals hereof.
“Loan Documents”: This Agreement, the Note, Senior Intercreditor Agreement, Ligand Intercreditor Agreement and all other documents, instruments and certificates entered into in connection with any of the foregoing.
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“Marketing Approval”: An approval by the FDA, a Marketing Authorization Application approved by the EMA under the centralized European procedure, or any corresponding non-U.S. or non-EMA application, registration or certification, as applicable, necessary to market a Product approved by the corresponding Regulatory Authority worldwide, as applicable, including pricing and reimbursement approvals where required.
“Material Adverse Effect”: Any change, circumstance, development, state of facts, event or effect (i) that has had or would reasonably be expected to have a material adverse change or effect (taken alone or in the aggregate with any other adverse change or effect) in or with respect to the business, properties, assets, financial condition, liabilities, or results of operations of the Borrower and its Subsidiaries, taken as a whole or (ii) that prevents or materially impedes, interferes with, hinders or delays the consummation by the Borrower (or any other Person obligated to perform the Borrower’s obligations under the Loan Documents) of the transactions contemplated by this Agreement; provided, however, that none of the following shall be taken into account in determining whether there has been a “Material Adverse Effect”: (1) the effects of changes that are generally applicable to the industry and markets in which the Borrower operates provided that the Borrower is not materially disproportionately adversely affected thereby relative to other industry participants, or (2) the effects of changes that are generally applicable to the economy or securities markets in the United States or the world economy or international securities markets provided that the Borrower is not materially disproportionately adversely affected thereby relative to other industry participants.
“Material Adverse Event”: The occurrence of an event or condition, including, without limitation, any Force Majeure, that has had, or would reasonably be expected to have (a) a Material Adverse Effect upon the Credit Parties, taken as a whole, or on the ability of the Borrower or any other Person obligated thereunder to perform its obligations under the Loan Documents, or (b) a material impairment of the rights and remedies of the Lender under any Loan Document, including, but not limited to, a material impairment in the perfection or priority of the Lenders’ Lien in the Collateral.
“Maturity Date”: The fifth anniversary of the Closing Date.
“Note”: As defined in Section 2.1.
“Obligations”: The obligations of the Borrower: (a) to pay the principal of and interest on the Note in accordance with the terms hereof and thereof, and to satisfy all of the Borrower’s other obligations to the Lender hereunder, whether now existing or hereafter incurred, matured or unmatured, including any extensions, modifications, renewals thereof and substitutions therefor (b) to repay to the Lender all amounts advanced by the Lender hereunder or otherwise on behalf of the Borrower, including, but without limitation, advances for principal or interest payments to prior secured parties, mortgagees or lienors; (c) to issue the Revenue Share Credit to the Lender or other Persons designated by the Lender; (d) to pay all other amounts due to the Lender under this Agreement and the Loan Documents; and (e) to pay all of the Lender’s expenses and costs, together with the reasonable fees and expenses of its counsel in connection with any proceedings brought or threatened to enforce payment of any of the Obligations described in clauses (a) through (d) pursuant to the express terms hereof.
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“Obligations are Satisfied”: All Obligations have been indefeasibly satisfied (whether by payment, conversion (including by conversion of the Obligations to the Revenue Share Credit pursuant to the terms of the Note) or otherwise) or paid in full.
“OFAC”: As defined in Section 7.7.
“Out-License” Each license or other agreement (or series of agreements) between Parent or any of its Affiliates and any Third Party (other than Distributors) pursuant to which Parent or any of its Affiliates (a) grants a license or sublicense under, or (b) sells, transfers or assigns (including by way of merger or consolidation), in each case, any Intellectual Property Right related to the development or Commercialization of a Product worldwide. For the avoidance of doubt, “Out-License” shall include each of the License Agreement and the Terumo Agreement.
“Patent”: All patents (including all reissues, divisionals, provisionals, continuations and continuations-in-part, re-examination certificates, post-issuance certificates, renewals, substitutions and extensions thereof), patent applications and other patent rights and any other governmental authority-issued indicia of invention ownership (including inventor’s certificates, petty patents and patent utility models).
“Patent License”: Any written agreement granting any right with respect to any invention on which a Patent is in existence or a Patent application is pending, in which agreement Borrower now holds or hereafter acquires any interest.
“Patent Rights”: Any and all material Patents owned or in-licensed by Parent or any of its Affiliates or under which Parent or any of its Affiliates is or may become empowered to grant licenses (including, for the avoidance of doubt, material Patents related to Improvements) that are necessary or used in the development, manufacture, use, or Commercialization of the Products in any country worldwide.
“Permit(s)”: As defined in Section 7.10.
“Permitted Indebtedness”: (a) Indebtedness of Borrower to the Lender under this Agreement, (b) the Senior Obligations, (c) the Ligand Obligations, (d) Indebtedness arising from the endorsement of instruments in connection with Trade Accounts Payable, and (e) unsecured Indebtedness provided by third parties to the Borrower.
“Permitted Lien”: Any Lien of a kind specified in paragraphs (a) through (h) of Section 8.5.
“Person”: Any natural person, corporation, partnership, joint venture, firm, association, trust, unincorporated organization, government or governmental agency or political subdivision or any other entity, whether acting in an individual, fiduciary or other capacity.
“Product Collateral”: All of Parent’s or any of its Affiliates’ rights, title and interest in, to and under the following, whether now owned or hereafter acquired: (a) the Product Rights, (b) the Products, and (c) any “proceeds” (as defined in the UCC) of the foregoing.
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“Product Rights”: Any and all of the following, as they exist worldwide as of the date hereof and during the term of this Agreement, in each case that are related to a Product: (a) Intellectual Property Rights, (b) Regulatory Submissions with respect to the Products, (c) In-Licenses, and (d) Out-Licenses.
“Products”: Any and all, (i) atrioventricular interval modulation, including the product known as of the date hereof as BackBeat Cardiac Neuromodulation Therapy™, and any Improvement thereof or thereto (including, for the avoidance of doubt, any product that constitutes a “Product” (as defined in the License Agreement) under the License Agreement and (ii) sirolimus angioinfusion balloon products, including the product known as of the date hereof as Virtue^®^ Sirolimus AngioInfusion Balloon, and any Improvement thereof or thereto (including, for the avoidance of doubt, any product that constitutes a “Product” (as defined in the Terumo Agreement) under the Terumo Agreement.
“Regulatory Authority”: Any national, supranational, regional, state or local regulatory agency, department, bureau, commission council or other governmental entity whose review or approval is legally required for the manufacture, packaging, use, storage, import, export, distribution or promotion of a medical device product in the applicable jurisdiction, including the FDA and the EMA.
“Regulatory Submissions”: All applications, approvals, licenses, notifications, registrations, submissions an authorizations made to a Regulatory Authority in connection with the development, manufacture or Commercialization of a medical device product, including any marketing and reimbursements.
“Regulated Products”: The Borrower’s medical device products and product candidates.
“Repayment Date”: The date that is the earliest of (i) the Maturity Date; and (ii) the date that Obligations under the Note are accelerated pursuant to Section 9.2.
“Restricted License”: Any material License or other 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 interfere with Lender’s right to sell any Collateral.
“Revenue Interest Agreement”: That certain Revenue Participation Right Purchase and Sale Agreement, dated as of the date hereof, between the Borrower and Ligand.
“Revenue Share Credit”: As defined on Appendix A of the Note.
“Security Documents”: Collectively, this Agreement, and all other security agreements, pledge agreements, patent and trademark security agreements, lease assignments, mortgages, deeds of trust, key man life insurance assignments, control agreements, guarantees and other similar agreements, by or between any one or more of Credit Party and Lender, now or hereafter delivered to Lender pursuant to or in connection with the transactions contemplated hereby, and all financing statements (or comparable documents now or hereafter filed in accordance with the UCC or comparable law) against any such Person, as debtor, in favor of Lender, as secured party.
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“SEC”: The U.S. Securities and Exchange Commission.
“SEC Filings”: As defined in Section 6.5.
“Securities Act”: The U.S. Securities Act of 1933, as amended, and all of the rules and regulations promulgated thereunder.
“Senior Intercreditor Agreement”: The Subordination Agreement, dated as of the date hereof, between Lender, Ligand and Hercules Capital, Inc., as administrative and collateral agent for the Senior Lenders.
“Senior Obligations”: The obligations of Borrower under that certain Loan and Security Agreement, dated November 6, 2024 (as amended as of the date hereof), among the Borrower, certain other affiliates of Borrower named therein, the “Lender” parties named therein, and Hercules Capital, Inc., as administrative and collateral agent for such Lenders (such “lender” parties, the “Senior Lender”).
“Senior Lenders”: As defined in the definition of Senior Obligations.
“Subordinated Debt”: Any unsecured Indebtedness of any Credit Party that is on terms and conditions satisfactory to, and is subject to a subordination agreement that has been approved in writing by, the Lender in its sole discretion.
“Subsidiary”: Any Person of which or in which the Borrower and its other Subsidiaries own directly or indirectly 50% or more of: (a) the combined voting power of all classes of stock having general voting power under ordinary circumstances to elect a majority of the board of directors of such Person, if it is a corporation, (b) the capital interest or profit interest of such Person, if it is a partnership, joint venture or similar entity, or (c) the beneficial interest of such Person, if it is a trust, association or other unincorporated organization.
“Terumo Agreement”: That certain Distribution Agreement, dated as of June 13, 2019, by and between Terumo Medical Corporation and Parent, as amended by that certain Amendment to Distribution Agreement, dated as of June 30, 2020 by and between Terumo Medical Corporation and Parent, as further amended by that certain Letter Agreement, dated as of June 20, 2022, by and between Terumo Medical Corporation and Parent, and as may be further amended from time to time.
“Third Party”: Any Person that is not Parent or Parent’s Affiliates or Ligand or the Ligand’s Affiliates.
“Trade Accounts Payable”: The trade accounts payable of any Person with a maturity of not greater than 120 days incurred in the ordinary course of such Person’s business.
“Trademark License”: Any written agreement granting any right to use any Trademark or Trademark registration, now owned or hereafter acquired by Borrower or in which Borrower now holds or hereafter acquires any interest.
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“Trademark Rights”: Any and all material Trademarks owned or in-licensed by Parent or any of its Affiliates or under which Parent or any of its Affiliates is or may become empowered to grant licenses (including, for the avoidance of doubt, material Trademarks related to Improvements) necessary or used in the development, manufacture, use, or Commercialization of the Products worldwide.
“Trademarks”: All trademarks (registered, common law or otherwise) and any applications in connection therewith, including registrations, recordings and applications in the United States Patent and Trademark Office or in any similar office or agency of the United States of America, any State thereof or any other country or any political subdivision thereof.
Section 1.2 AccountingTerms and Calculations. Except as may be expressly provided to the contrary herein, all accounting terms used herein shall be interpreted and all accounting determinations hereunder shall be made in accordance with GAAP, consistently applied.
Section 1.3 OtherDefinitional Terms. The words “hereof,” “herein” and “hereunder” and words of similar import when used in this Agreement shall refer to this Agreement as a whole and not to any particular provision of this Agreement. References to Sections, Exhibits, Schedules and like references are to this Agreement unless otherwise expressly provided. The terms defined in the singular shall have a comparable meaning when used in the plural, and vice versa. The word “including” or any variation thereof means (unless the context of its usage otherwise requires) “including, without limitation” and shall not be construed to limit any general statement that it follows to the specific or similar items or matters immediately following it. To the extent that a term or provision of this Note is applicable to “Borrower”, it is applicable to each and every Borrower unless the context expressly indicates otherwise.
Article 2
LOAN
Section 2.1 Borrowing. Subject to the terms and conditions of this Agreement, the Lender agrees to make the Loan at the Closing (as defined below), in the aggregate principal amount equal to $20,000,000. The Loan shall be evidenced by a Secured Subordinated Promissory Note in substantially in the form of Exhibit A attached hereto (the “Note”). No amounts of the Loan repaid may be reborrowed.
Section 2.2 Closing. The issuance of the Note to the Lender and the funding of the Loan by the Lender to the Borrower shall take place remotely via the exchange of documents and signatures on the Funding Date or at such other time and place as the Borrower and the Lender mutually agree (which time and place are designated as the “Closing,” and the date thereof, the “Closing Date”). Subject to the terms and subject to the conditions set forth in this Agreement, at the Closing, the Lender shall make the Loan to Borrower pursuant to this Article 2 if all of the applicable conditions precedent set forth in Section 5.1 are satisfied or waived by the Lender.
Section 2.3 Expensesand Advances Secured. The Obligations, including all disbursements, advancements and payments made by the Lender and payable by the Borrower hereunder, all amounts expended by the Lender pursuant and subject to the provisions hereof, the Lender’s attorney’s fees, if any, as and when advanced or incurred by the Lender will be secured by the Loan Documents.
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Section 2.4 SubordinationAgreement. Lender acknowledges, covenants and agrees that the payment or other satisfaction of the Obligations will be subordinate in right of payment to the prior payment in full of the Senior Obligations pursuant to the terms of the Subordination Agreement. Lender further covenants and agrees, as a condition to its purchase of the Note under this Agreement, to execute and deliver the Subordination Agreement.
Section 2.5 Useof Proceeds. The Borrower will use the proceeds of the Loan solely for the continued funding and support of the Clinical Trial and such other activities directly associated with the Clinical Trial and the License Agreement.
Article 3
INTERESTAND COSTS
Section 3.1 Intereston Loan. The unpaid principal amount of the Loan shall bear simple interest at the Interest Rate and shall be computed on the basis of actual days elapsed and a year of 365 days. Lender’s internal records of applicable interest rates and accrual shall be determinative in the absence of manifest error.
Section 3.2 DefaultRate. During any period while an Event of Default exists under this Agreement, at the option of the Lender, the unpaid principal balance of the Note shall thereafter accrue interest at the Default Rate, until the unpaid principal balance is paid in full or such Event of Default is cured or waived as determined by Lender. If for any reason whatsoever the interest and other consideration payable to the Lender under the Loan Documents (as defined herein) exceeds the limit prescribed by any applicable usury statute or any other applicable law, then such interest and other consideration shall be reduced to the limit provided in such statute or law, so that in no event shall such interest and other consideration be in excess of such limit. If any payments of interest or other consideration have been made to the Lender in excess of such limits, such excess amount shall be applied to the principal balance or, if the Loan has been fully paid, refunded to Borrower.
Section 3.3 PaymentDates. Interest accruing on the Loan shall be due and payable as specified in the Note.
Section 3.4 IncreasedCosts. If, as a result of any generally applicable law, rule, regulation, treaty or directive, or any generally applicable change therein or in the interpretation or administration thereof, or compliance by the Lender with any generally applicable request or directive (whether or not having the force of law) from any court, central bank, Governmental Authority, agency or instrumentality, or comparable agency, in each case after the date hereof:
(a) any tax, duty or other charge with respect to a Note is imposed, modified or deemed applicable, or the basis of taxation of payments to the Lender of interest or principal of the Loan (other than taxes imposed on the overall net income of the Lender by the jurisdiction in which the Lender has its principal office) is changed; or
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(b) any reserve, special deposit, special assessment or similar requirement against assets of, deposits with or for the account of, or credit extended by, the Lender is imposed, modified or deemed applicable;
and the Lender reasonably and in good faith determines that, by reason thereof, the cost to the Lender of making or maintaining the Loan is increased, or the amount of any sum receivable by the Lender hereunder or under any Note in respect of the Loan is reduced; then, the Borrower shall pay to the Lender upon demand (which demand shall include sufficient evidence thereof) such additional amount or amounts as will compensate the Lender for such additional costs or reduction. Determinations by the Lender for purposes of this Section 3.4 of the additional amounts required to compensate the Lender shall be conclusive in the absence of manifest error. In determining such amounts, the Lender may use any reasonable averaging, attribution and allocation methods.
Section 3.5 Expenses. The Borrower shall pay its own and the Lender’s reasonable and documented out-of-pocket legal fees in relation to the negotiation, preparation, execution and closing of this Agreement and the other Loan Documents which shall be paid from the proceeds of the Loan if so desired by the Lender. Such Lender expenses incurred through the Closing Date shall not exceed, in the aggregate, $150,000 (the “Fee Reimbursement Amount”). Notwithstanding the foregoing, the Borrower agrees to reimburse the Lender upon demand for all expenses paid or incurred by the Lender (including without limitation, any filing or recording fees, appraisal fees and expenses, and reasonable fees and expenses of legal counsel) in connection with any collection and enforcement this Agreement and the other Loan Documents.
Article 4
PAYMENTSAND PREPAYMENTS
Section 4.1 Repayment. Principal and accrued and unpaid interest under the Loan shall be due and payable as specified in the Note.
Section 4.2 Prepayments. Upon the occurrence of an Event of Default and the acceleration of any Note, pursuant to and as permitted by Section 9.2, the Note and all other monetary Obligations, shall be immediately due and payable as provided in Section 9.2 and the Note. Otherwise, prepayments of principal and interest owing under the Note may not be prepaid without the prior written consent of the Lender. Any such prepayment shall be applied first to accrued interest and then to the reduction of principal of the Note.
Section 4.3 Payments. Payments and prepayments of principal of, and interest on, the Note and all fees, expenses and other obligations under the Loan Documents shall be made without set-off or counterclaim in immediately available funds not later than 5:00 p.m., Minneapolis time, on the Repayment Date, unless such amounts are earlier converted in accordance with the terms and conditions of the Note. Funds received on any day after such time shall be deemed to have been received on the next Business Day. Whenever any payment to be made under any Loan Document shall be stated to be due on a day which is not a Business Day, such payment shall be made on the next succeeding Business Day and such extension of time shall be included in the computation of any interest or fees.
Section 4.4 Taxes. Any and all payments by the Borrower under this Agreement and each other Loan Document shall be subject to all applicable withholding taxes.
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Article 5
CONDITIONSPRECEDENT
Section 5.1 Conditionsto Closings. The obligation of the Lender to make the Loan hereunder shall be subject to the satisfaction of the conditions precedent, in addition to the conditions precedent set forth in Article 2 above, that the Lender shall have received at or prior to the Closing the following, each in form and substance satisfactory to the Lender, where applicable, duly executed and certified or dated as of the Closing Date or such other date as is satisfactory to the Lender:
(a) The written consent or resolutions of the board of directors (or similar governing body) of the Borrower, approving the transactions contemplated hereby.
(b) The Note, duly executed by the Borrower.
(c) The IP Security Agreement(s), duly executed by the Borrower.
(d) Each other Loan Document, each duly executed by the Borrower, and all other customary closing instruments, documents, certificates and agreements executed or delivered pursuant thereto (including intellectual property assignments and pledged Collateral, with undated irrevocable transfer powers executed in blank).
(e) The License Agreement remains in full force and effect.
(f) A Certificate of Good Standing of the Borrower, as of a recent date and issued by the Secretary of State of the State of Delaware.
(g) An Officer’s Certificate of the Borrower certifying (i) a copy of the Borrower’s charter (or similar formation document) with all amendments thereto, certified by the Secretary of State of the State of Delaware, (ii) a copy of its bylaws (or similar governing document) and other organizational documents with all amendments thereto, (iii) a copy of all resolutions authorizing the execution, delivery and performance of the Loan Documents to which it is a party, (iv) the names, titles, and signatures of its managers/officers authorized to execute and perform the Loan Documents to which it is a party, and (v) that all of the Borrower’s representations and warranties set forth in the Loan Documents are true and correct in all material respects (without duplication of any materiality qualifiers contained therein), no Default or Event of Default then exists, the Borrower is in compliance with all covenants set forth in the Loan Documents and all conditions to closing the Loan Documents have been satisfied.
(h) Customary opinions of counsel to the Credit Parties addressed to the Lender.
(i) Senior Intercreditor Agreement.
(j) Ligand Intercreditor Agreement.
(k) Such lien, tax lien, judgment, litigation, bankruptcy and intellectual property searches as the Lender may reasonably request.
(l) Such termination statements and releases as the Lender may reasonably request.
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(m) Such third-party and governmental consents as are necessary for the Borrower to consummate the transactions contemplated hereby, including any such consents required by the Senior Lenders or Ligand, and all applicable waiting periods shall have expired without any action being taken or threatened by any competent authority that would restrain, prevent or otherwise impose adverse conditions on any of the transactions contemplated hereby.
(n) A certificate of the chief financial officer of the Borrower, in a form acceptable to the Lender, certifying that, both before and after giving effect to the Loan to be made hereunder and the payment and accrual of all transactions costs for which the Borrower is obligated to pay in connection with the foregoing, the Borrower is and will be solvent.
(o) Such other documents or instruments as the Lender may reasonably request to consummate the transactions contemplated hereby.
(p) As of the Closing, no Material Adverse Event shall have occurred and be continuing.
(q) At the Closing, the payment of the Fee Reimbursement Amount pursuant to Section 3.5 hereof (which may be deducted from the Lender’s advance of the Loan) and any other fees and expenses subject to reimbursement hereunder.
(r) The transactions contemplated by that certain Stock Purchase Agreement between Lender and Orchestra Biomedical Holdings, Inc., dated as of even date herewith, shall have been consummated.
(s) Evidence satisfactory to the Lender that (i) the Borrower and Ligand have executed and delivered the Revenue Interest Agreement in a form substantially similar to the form attached as Exhibit B hereto, and (ii) as of the Closing Date, Parent has received from Ligand the entire Second Installment as described in such Revenue Interest Agreement.
(t) Evidence satisfactory to the Lender that, as of the Closing Date, the enrollment of subjects in the Clinical Trial has not been suspended (unless such suspension has been lifted), placed on clinical hold, terminated or otherwise stopped for any reason other than if full enrollment of the required number of subjects has been achieved in accordance with the applicable protocol for the Clinical Trial.
(u) At least five days prior to the Closing Date, the Lender shall have received all documentation and other information regarding the Borrower requested in connection with applicable “Know Your Customer” and anti-money laundering rules and regulations, including the USA Patriot Act.
(v) As of the Funding Date, Certificates or other evidence of insurance required by Section 7.3(a).
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Article 6
THEBORROWER’S REPRESENTATIONS AND WARRANTIES
To induce the Lender to enter into this Agreement, and to make the Loan hereunder, the Borrower represents and warrants to the Lender as of the date of this Agreement and on the Closing Date:
Section 6.1 Organization,Standing, Capitalization, Etc. The Borrower is a corporation or limited liability company, as applicable, duly organized or formed and validly existing and in good standing under the laws of the State of Delaware, and has all requisite corporate or company power, as applicable, and authority to carry on its businesses as now conducted and as proposed to be conducted, to enter into the Loan Documents and to perform its obligations under the Loan Documents. The Borrower is duly qualified and in good standing as a foreign entity in each jurisdiction in which the character of the properties owned, leased or operated by it or the business conducted and as proposed to be conducted by it makes such qualification necessary, and where the failure to so qualify could reasonably be expected to result in a Material Adverse Event. The Borrower holds all certificates of authority, licenses and permits necessary to carry on its business as presently conducted and as proposed to be conducted in each jurisdiction in which it carries or proposes to carry on such business. Schedule 6.1 attached hereto (which may be updated as of the Closing) sets forth a true and accurate (i) summary of Borrower’s outstanding capitalization and (ii) list of each Subsidiary of Borrower and Borrower’s ownership interest therein.
Section 6.2 Authorizationand Validity. The execution, delivery and performance by the Borrower of the Loan Documents have been duly authorized by all necessary corporate or company action by the Borrower, and the Loan Documents constitute the legal, valid and binding obligations of the Borrower, enforceable against the Borrower in accordance with their respective terms, subject to limitations as to enforceability which might result from bankruptcy, insolvency, moratorium and other similar laws affecting creditors’ rights generally and subject to limitations on the availability of equitable remedies.
Section 6.3 NoConflict; No Default. The execution, delivery and performance by the Borrower of the Loan Documents will not (a) violate any provision of any law, statute, rule or regulation or any order, writ, judgment, injunction, decree, determination or award of any court, governmental agency or arbitrator presently in effect having applicability to the Borrower, (b) violate or contravene any provisions of the Borrower’s certificate of incorporation or bylaws or other organizational or governing documents, or (c) result in a breach of or constitute a default under any indenture, loan or credit agreement or any other agreement, lease or instrument to which the Borrower is a party or by which it or any of its properties may be bound or result in the creation of any Lien on any asset of the Borrower, other than Permitted Liens. The Borrower is not in default under or in violation of any such law, statute, rule or regulation, order, writ, judgment, injunction, decree, determination or award or any such indenture, loan or credit agreement or other agreement, lease or instrument in any case in which the consequences of such default or violation could reasonably be expected to result in a Material Adverse Event.
Section 6.4 GovernmentConsent. Except for such filings that are necessary to perfect the Liens granted by the Borrower to the Lender pursuant to the Loan Documents, no order, consent, approval, license, authorization or validation of, or filing, recording or registration with, or exemption by, any governmental or public body or authority is required on the part of the Borrower to authorize, or is required in connection with the execution, delivery and performance of, or the legality, validity, binding effect or enforceability of, the Loan Documents.
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Section 6.5 SECFilings; Financial Statements.
(a) The Borrower has filed all forms, statements, certifications, reports and documents required to be filed or furnished by it with the SEC under Section 13 and 15(d) of the Exchange Act for the one year preceding the date of this Agreement (the “SEC Filings”). As of the time it was filed or furnished 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 SEC Filing complied in all material respects with the applicable requirements of the Exchange Act, and, as of the time they were filed or furnished, none of the filed SEC Filings 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. There are no outstanding or unresolved comments from the SEC staff with respect to the SEC Filings. To Borrower’s Knowledge, none of the SEC Filings are the subject of an ongoing SEC review.
(b) The financial statements of the Borrower included in the SEC Filings (collectively, the “Financial Statements”) comply in all material respects with applicable accounting requirements and the rules and regulations of the SEC with respect thereto as in effect at the time of filing (or to the extent corrected by a subsequent restatement) and fairly present in all material respects the consolidated financial position of the Borrower as of the dates indicated, and the results of its operations and cash flows for the periods therein specified, all in accordance with GAAP (except as otherwise noted therein, and except that any unaudited financial statements may be subject to normal and recurring year-end adjustments) applied on a consistent basis throughout the periods therein specified (unless otherwise noted therein). Except as set forth in the Financial Statements filed prior to the date of this Agreement, the Borrower has not incurred any liabilities, contingent or otherwise, except (i) those incurred in the ordinary course of business, consistent with past practices since the date of such financial statements or (ii) liabilities not required under GAAP to be reflected in the Financial Statements, in either case, none of which, individually or in the aggregate, have had or would reasonably be expected to have a Material Adverse Effect.
Section 6.6 Litigation. Except as otherwise disclosed in the SEC Filings, there are no actions, suits or proceedings pending or threatened against or affecting the Borrower or any of its properties before any court or arbitrator, or any governmental department, board, agency or other instrumentality.
Section 6.7 Compliance;Regulatory.
(a) The Borrower is in material compliance with all statutes and governmental rules and regulations applicable to it.
(b) The Borrower has (1) no knowledge of any actual or threatened enforcement action or investigation by any governmental entity that has jurisdiction over its operations or reason to believe that any governmental entity is considering any such action, or (2) not received any written correspondence or notice from any Governmental Authority that has jurisdiction over its operations asserting noncompliance with any applicable law.
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(c) Each product or product candidate of Borrower, if any, subject to the FDCA or comparable laws in any non-U.S. jurisdiction that has been manufactured, tested or distributed by or on behalf of the Borrower, is being developed, manufactured, tested, distributed in material compliance with applicable requirements under the FDCA and comparable laws in any non-U.S. jurisdiction where Borrower is conducting business.
(d) The Borrower has timely filed or otherwise provided all reports, data, and other information and applications with respect to its medical device products (the “Regulated Products”), required to be filed with or otherwise provided to the FDA or any other governmental body with jurisdiction over the manufacture or use of the Regulated Products, has complied, in all material respects, with all applicable regulations of the FDA or other governmental body with respect to the Regulated Products, and all regulatory licenses or approvals in respect thereof are in full force and effect. All documentation, correspondence, reports, data, analyses, and certifications relating to or regarding any medical devices of the Borrower, prepared and either filed or delivered by or on behalf of the Borrower to any governmental body as part of obtaining clearance or approval from a Governmental Authority, were true and accurate when so filed in all material respects or delivered, and remain true and accurate in all material respects. Each study conducted by or on behalf of the Borrower (including the Clinical Trial) has been conducted or is being conducted such that, to the Borrower’s Knowledge, the resulting data will be acceptable for use in the Borrower’s regulatory filings, and, to the Borrower’s Knowledge, there is nothing included in such data that would cause any regulatory submission to be disallowed or delayed or that would indicate that the applicable product will not perform at the specified efficacy level as a result of the process or the manner in which the studies were conducted.
(e) Neither the Borrower nor any of its Affiliates have been debarred or convicted of a crime for which a Person can be debarred under 21 U.S.C. § 335a or any comparable law in any non-U.S. jurisdiction, nor have they been threatened to be debarred or indicted for a crime or otherwise engaged in conduct for which a Person can be debarred.
(f) The Borrower has not (and its directors, executives, representatives, agents or employees have not) (i) used or is using any company funds for any illegal contributions, gifts, entertainment or other unlawful expenses relating to political activity, (ii) used or is using any company funds for any direct or indirect unlawful payments to any foreign or domestic government officials or employees, (iii) violated or is violating any provision of the Foreign Corrupt Practices Act of 1977 or any comparable law in any non-U.S. jurisdiction, (iv) established or maintained, or is maintaining, any unlawful fund of company monies or other properties, (v) made any bribe, unlawful rebate, unlawful payoff, influence payment, kickback or other unlawful payment of any nature or (vi) made any other improper payments in violation of law.
Section 6.8 Ownershipof Property: Liens. The Borrower has good and marketable title to its ownership interests in real properties and good and sufficient title to its other properties and assets, tangible or intangible of any nature whatsoever. None of the properties, revenues or assets of the Borrower is subject to a Lien, except for Permitted Liens.
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Section 6.9 IntellectualProperty.
(a) Except as described on Schedule 6.9, Borrower has all material rights with respect to intellectual property necessary or material in the operation or conduct of Borrower’s business as currently conducted and proposed to be conducted by Borrower. Without limiting the generality of the foregoing, except for restrictions that are unenforceable under Division 9 of the UCC or otherwise permitted under this Agreement with respect to Licenses, Borrower has the right, to the extent required to operate Borrower’s business, to freely transfer, license or assign Intellectual Property necessary or material in the operation or conduct of Borrower’s business as currently conducted and proposed to be conducted by Borrower, without condition, restriction or payment of any kind (other than license payments in the ordinary course of business) to any third party, and Borrower owns or has the right to use, pursuant to valid licenses, all software development tools, library functions, compilers and all other third-party software and other items that are material in the operation or conduct of Borrower’s business and used in the design, development, promotion, sale, license, manufacture, import, export, use or distribution of Borrower Products except customary covenants in inbound license agreements and equipment leases where Borrower is the licensee or lessee. Borrower is not a party to, nor is it bound by, any Restricted License.
(b) No material software or other materials used by Borrower or any of its Subsidiaries (or used in any Borrower Products) are subject to an open-source or similar license (including but not limited to the General Public License, Lesser General Public License, Mozilla Public License, or Affero License) in a manner that would cause such software or other materials to have to be (i) distributed to third parties at no charge or a minimal charge (royalty-free basis); (ii) licensed to third parties to modify, make derivative works based on, decompile, disassemble, or reverse engineer; or (iii) used in a manner that requires disclosure or distribution in source code form.
(c) There are no material unpaid fees or royalties under any License that have become overdue. Each License is in full force and effect and is legal, valid, binding, and enforceable in accordance with its respective terms, except as may be limited by bankruptcy, insolvency, reorganization, moratorium or similar laws relating to or limiting creditors’ rights generally or by equitable principles relating to enforceability. Except as set forth on Schedule 6.9, to the Knowledge of Borrower, neither Borrower nor any of its Subsidiaries, as applicable, is in breach of or default in any manner that could reasonably be expected to materially affect the Borrower Products under any License to which it is a party, and no circumstances or grounds exist that would give rise to a claim of breach or right of rescission, termination or nonrenewal of any of the License, including the execution, delivery and performance of this Agreement and the other Loan Documents.
(d) Except as set forth on Schedule 6.9, no Intellectual Property owned by Borrower nor any Borrower Product has been or is subject to any actual or, to the Knowledge of Borrower, threatened litigation, proceeding (including any proceeding in the United States Patent and Trademark Office or any corresponding foreign office or agency) or outstanding decree, order, judgment, settlement agreement or stipulation that restricts in any manner Borrower’s use, transfer or licensing thereof or that may affect the validity, use or enforceability thereof. There is no decree, order, judgment, agreement, stipulation, arbitral award or other provision entered into in connection with any litigation or proceeding that obligates Borrower to grant licenses or ownership interest in any future Intellectual Property related to the operation or conduct of the business of Borrower or Borrower Products. Borrower has not received any written notice or claim, or, to the Knowledge of Borrower, oral notice or claim, challenging or questioning Borrower’s ownership in any Intellectual Property (or written notice of any claim challenging or questioning the ownership in any licensed Intellectual Property of the owner thereof) or suggesting that any third party has any claim of legal or beneficial ownership with respect thereto nor, to Borrower’s Knowledge, is there a reasonable basis for any such claim. To the Knowledge of the Borrower, neither Borrower’s use of its Intellectual Property nor the production and sale of Borrower Products infringes the Intellectual Property or other rights of others.
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Section 6.10 Subsidiaries;Investments. Other than listed on Exhibit 21.1 of Borrower’s most recent Annual Report on Form 10-K, the Borrower does not have any Subsidiaries, nor does the Borrower own any Investments.
Section 6.11 Taxes. The Borrower has filed all national, federal, state and local tax returns required to be filed and has paid or made provision for the payment of all taxes due and payable pursuant to such returns and pursuant to any assessments made against it or any of its property and all other taxes, fees and other charges imposed on it or any of its property by any Governmental Authority (other than taxes, fees or charges the amount or validity of which is currently being contested in good faith by appropriate proceedings and with respect to which reserves in accordance with GAAP have been provided on the books of the Borrower). No tax Liens have been filed and no material claims are being asserted with respect to any such taxes, fees or charges. The charges, accruals and reserves on the books of the Borrower in respect of taxes and other governmental charges are adequate.
Section 6.12 NoBroker. No broker or finder on behalf of the Borrower brought about the obtaining, making or closing of the Loan or the Loan Documents, and the Borrower has no obligation to any Person in respect of any finder’s or brokerage fees in connection therewith.
Section 6.13 Solvency. Both before and after giving effect to the Loan to be made hereunder and the payment and accrual of all transactions costs for which the Borrower is obligated to pay in connection with the foregoing, the Borrower is and will be solvent.
Section 6.14 InvestmentCompany Act; Margin Laws. Neither Borrower nor any other Credit Party is an “investment company,” a company that would be an “investment company” except for the exclusion from the definition of “investment company” in Section 3(c) of the Investment Company Act of 1940, as amended, or a company “controlled” by an “investment company” under such. Neither Borrower nor any of its Subsidiaries is 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).
Section 6.15 Compliancewith Anti-Terrorism Laws. The Borrower is not in violation of any law, regulation or list of any government agency including, without limitation, the U.S. Office of Foreign Asset Control list, Executive Order 13224 or the USA Patriot Act, that prohibits or limits the conduct of business with or receiving of funds, goods or services to or for the benefit of certain Persons specified therein or that prohibits or limits the Lender from making any Loan or extension of credit to the Borrower or from otherwise conducting business with the Borrower.
Section 6.16 Accuracyof Disclosures. No representation or warranty by the Borrower contained herein or in any other Loan Document, or in any certificate or other document furnished heretofore or concurrently with the signing of this Agreement or any other Loan Document by the Borrower to the Lender in connection with the transactions contemplated hereunder or under any other Loan Document contained, or, when taken as a whole, contains any material misstatement of fact or, when taken together with all other such information or documents, omitted or omits to state any material fact necessary to make such representation or warranty not materially misleading at the time such representation or warranty was made or deemed made.
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Section 6.17 Survivalof Representations. All of the representations and warranties contained in this Agreement shall survive the execution and delivery of this Agreement.
Section 6.18 Insurance. The Borrower, each other Credit Party, each Subsidiary of each Credit Party and their respective properties are insured with financially sound and reputable insurance companies such insurance in such amounts and against such risks as is not violative of the Senior Obligations and may be required by law or as may be customary in the case of reputable companies engaged in the same or similar business and similarly situated, including, without limitation, clinical trial liability.
Article 7
AFFIRMATIVECOVENANTS OF THE BORROWER
From the date of this Agreement and thereafter until the Obligations are Satisfied and this Agreement is terminated, unless the Lender shall otherwise expressly consent in writing, the Borrower will do all of the following:
Section 7.1 Information. Furnish to the Lender, from time to time, such information regarding the business, operation and financial condition of the Borrower as the Lender may reasonably request.
Section 7.2 BorrowerExistence. Maintain its corporate or company existence in good standing under the laws of the State of Delaware and its qualification to transact business in each jurisdiction in which the character of the properties owned, leased or operated by it or the business conducted by it makes such qualification necessary. Without limiting the generality of the foregoing, the Borrower will maintain all of its certificates, permits, licenses and agreements of any kind or nature necessary to the operation of its business in full force and effect and in good standing.
Section 7.3 Insurance.
(a) Maintain with financially sound and reputable insurance companies such insurance in such amounts and against such risks as is not violative of the Senior Obligations and may be required by law or as may be customary in the case of reputable companies engaged in the same or similar business and similarly situated, including, without limitation, clinical trial liability (it being understood that the insurance held by the Borrower on the date hereof is deemed to satisfy this requirement). Upon reasonable request by the Lender, the Borrower Representative shall furnish to the Lender written evidence as to any insurance maintained by the Borrower. All policies shall contain the insurer’s promise not to cancel the policy without endeavoring to provide 30 days’ prior written notice to the Lender at its address set forth below. All policies shall name the Lender as an additional insured or lender loss payee, as appropriate, as its interests may appear,
(b) Unless the Borrower Representative provides the Lender with evidence of the continuing insurance coverage required by this Agreement within five Business Days after written request therefor by the Lender, the Lender may purchase insurance at the Borrower’s expense to protect the Lender’s interests in the Collateral. This insurance may, but need not, protect the Borrower’s, each other Credit Party’s and each Credit Party’s Subsidiaries’ interests. The coverage that Lender purchases may, but need not, pay any claim that is made against the Borrower, any other Credit Party or any Subsidiary of any Credit Party in connection with the Collateral. The Borrowers may later cancel any insurance purchased by the Lender, but only after providing the Lender with evidence that the Borrower has obtained the insurance coverage required by this Agreement. If the Lender purchases insurance for the Collateral, as set forth above, the Borrower will be responsible for the costs of that insurance, including interest and any other charges that may be imposed with the placement of the insurance, until the effective date of the cancellation or expiration of the insurance and the costs of the insurance may be added to the principal amount of the Loans owing hereunder.
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Section 7.4 Paymentof Taxes and Claims. File all tax returns and reports which are required by law to be filed by it and pay before they become delinquent all taxes, assessments and governmental charges and levies imposed upon it or its property and all claims or demands of any kind (including, without limitation, those of suppliers, mechanics, carriers, warehouses, landlords and other like Persons) which, if unpaid, might result in the creation of a Lien (other than Permitted Liens) upon its property; provided that the foregoing items need not be paid if they are being contested in good faith by appropriate proceedings, and as long as its title to its property is not materially adversely affected, its use of such property in the ordinary course of its business is not materially interfered with and adequate reserves with respect thereto have been set aside on its books in accordance with GAAP. In addition, and without limitation, promptly pay all Trade Accounts Payable.
Section 7.5 Maintenanceof Properties; Protection of Intellectual Property. Maintain its properties used or useful in the conduct of its business in good condition, repair and working order, ordinary wear and tear excepted, and supplied with all necessary equipment, and make all necessary repairs, renewals, replacements, betterments and improvements thereto, all as may be reasonably necessary so that the business carried on in connection therewith may be conducted at all times. The Borrower shall use commercially reasonable efforts to preserve, obtain and maintain its Intellectual Property. The Borrower shall take all actions required to keep its material Intellectual Property pending or in effect, including prosecution of patent applications, payment of filing, examination, annuity, registration and maintenance fees and filing of renewals, responses, amendments, statements of use or working, affidavits of incontestability and other similar actions, if and as applicable. If the Borrower wishes to abandon any asset included in its material Intellectual Property (including issued patents or pending patent applications) or forego an opportunity to file continuing patent applications (including continuations, divisionals, CIPs, reissues, and other applications claiming priority from Borrower’s patent applications) with respect to such Intellectual Property, it shall notify the Lender sufficiently in advance to permit the Lender to obtain and maintain such asset without a loss of rights, and the Lender shall have the right, but not the obligation, to obtain and maintain such asset in full force and effect. The Borrower shall cooperate with the Lender if the Lender seeks to obtain and/or maintain any such asset.
Section 7.6 Booksand Records. Keep adequate and proper records and books of account in which full and correct entries will be made of its dealings, business and affairs.
Section 7.7 Compliance. Materially comply with the requirements of all applicable state and federal laws, and of all rules, regulations, orders, writs, judgments, injunctions, decrees or awards to which it may be subject, including, without limitation, those set forth in this Section 7.7. Without limiting the foregoing sentence, Borrower will ensure that no Person who owns a controlling interest in or otherwise controls Borrower is or shall be (i) listed on the Specially Designated Nationals and Blocked Person List maintained by the Office of Foreign Assets Control (“OFAC”), Department of the Treasury, and/or any other similar lists maintained by OFAC pursuant to any authorizing statute, Executive Order or regulation or (ii) a Person designated under Section 1(b), (c) or (d) of Executive Order No. 13224 (September 23, 2001), any related enabling legislation or any other similar Executive Orders, and (c) without limiting clause (a) above, Borrower shall comply with all applicable Bank Secrecy Act and anti-money laundering laws and regulations.
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Section 7.8 Noticeof Litigation. Promptly provide written notice to the Lender of all litigation, arbitration or mediation proceedings, of any threats of such proceedings, of any allegations of intellectual property infringement, of any adversarial proceedings at the U.S. Patent and Trademark Office or any other intellectual property office, and of all proceedings by or before any court or governmental or regulatory agency affecting the Borrower, which alone or in the aggregate seeks in excess of $250,000, describing the nature thereof and the steps being taken with respect to such proceeding.
Section 7.9 Noticeof Default.
(a) Promptly provide written notice to the Lender of any Default of which the Borrower has Knowledge or of any Event of Default, describing the nature thereof and what action the Borrower proposes to take with respect thereto.
(b) Promptly following receipt or execution thereof, as applicable, copies of any written notices (including notices of default or acceleration), amendments, forbearance, waivers, modifications, or consents received from any holder or trustee of, under or with respect to the Senior Obligations, Ligand Obligations or any Subordinated Debt.
Section 7.10 Permits. Comply in all material respects with the terms of all permits, licenses, authorizations, consents, approvals and franchises from governmental entities necessary to conduct its business (each a “Permit” and collectively, the “Permits”) except where failure to so comply could not reasonably be expected to result in a Material Adverse Event.
Section 7.11 Inspection;Audits. At reasonable times and upon reasonable notice to the Borrower Representative and during regular business hours, permit any Person designated by the Lender at the Lender's expense to visit and inspect any of its properties, company books and financial records, to examine and to make copies of its books of accounts and other financial records, to discuss its affairs, finances and accounts with, and to be advised as to the same by, its officers, and to conduct such collateral audits and appraisals, at such times and intervals as the Lender may reasonably designate; provided that such inspection shall occur no more than twice per fiscal year so long as no Event of Default has occurred and is continuing, and after the occurrence of any Event of Default, the expenses of the Lender for such visits, inspections, examinations, audits and appraisals shall be at the expense of the Borrower. Further, the Lender shall be entitled, but is not obligated, to participate in quarterly meetings with senior management and other key clinical personnel of the Borrower regarding the Borrower’s progress, as determined by the Lender using its sole discretion.
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Section 7.12 Changeof Control Notice. The Borrower shall notify the Lender in writing of the anticipated occurrence of a Change of Control at least ten Business Days prior to the anticipated closing date of such Change of Control.
Article 8
NEGATIVECOVENANTS OF THE BORROWER
From the date of this Agreement and thereafter until the Obligations are Satisfied and the Agreement is terminated, unless the Lender shall otherwise expressly consent in writing, the Borrower will not do any of the following, and the Borrower will not cause or allow any of its Subsidiaries, if any, to do any of the following:
Section 8.1 [Reserved].
Section 8.2 Changein Nature of Business. Conduct any business other than the research, development and commercialization of biomedical devices and related technology and any other business (or reasonably related or incidental to) conducted by the Borrower on the Closing Date and any other actions reasonably required to be performed to accomplish the purpose of this Agreement.
Section 8.3 OtherAgreements. Either: (a) enter into any agreement, bond, note or other instrument with or for the benefit of any Person other than the Lender which would be violated or breached by its performance of the Obligations or its performance of its obligations under the Loan Documents; or (b) enter into any agreement, bond, note or other instrument with or for the benefit of any Person other than the Lender which would adversely affect the Collateral.
Section 8.4 RestrictedPayments. Either: (a) purchase or redeem or otherwise acquire for value any of its equity interests (other than the repurchase of equity interests from departing employees or consultants upon termination of their employment or services), declare or pay any dividends or distributions with respect to any of its equity interests, make any distribution on, or payment on account of the purchase, redemption, defeasance or other acquisition or retirement for value of, any of its equity interests or set aside any funds for any such purpose; or (b) directly or indirectly make any payment on, or redeem, repurchase, defease, or make any sinking fund payment on account of, or any other provision for, or otherwise pay, acquire or retire for value, any of its Indebtedness that is subordinated in right of payment to the Loan (whether pursuant to its terms or by operation of law), except for payments that are not otherwise prohibited under the document or agreement stating the terms of such subordination.
Section 8.5 Liens. Create, incur, assume or suffer to exist any Lien with respect to any Collateral now owned or hereafter arising or acquired, except:
(a) Liens in favor of the Lender;
(b) Liens in favor of the Senior Lenders in respect of the Senior Obligations;
(c) Liens in favor of Ligand in respect of the Ligand Obligations;
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(d) Deposits or pledges to secure payment of workers’ compensation, unemployment insurance, old age pensions or other social security obligations, in the ordinary course of its business;
(e) Liens for taxes, fees, assessments and governmental charges not delinquent or being contested in good faith by appropriate actions or to the extent that payments therefor shall not at the time be required to be made in accordance with the provisions of Section 7.4;
(f) Liens of carriers, warehousemen, mechanics and materialmen, and other like Liens arising in the ordinary course of business, for sums not due or to the extent that payment therefor shall not at the time be required to be made in accordance with the provisions of Section 7.4;
(g) Liens arising from judgments not constituting an Event of Default; and
(h) Liens that are minor or create technical defects in title that in the aggregate do not materially affect the value, marketability or utility of the Collateral.
Section 8.6 Useof Proceeds. Permit any proceeds of the Loan to be used for any purpose other than as set forth in Section 2.5 above.
Section 8.7 GovernmentRegulation. (a) Be or become subject at any time to any law, regulation, or list of any government agency (including, without limitation, the U.S. Office of Foreign Asset Control list) that prohibits or limits the Lender from making any advance or extension of credit to the Borrower or from otherwise conducting business with the Borrower, or (b) fail to provide documentary and other evidence of the Borrower’s identity as may be requested by the Lender at any time to enable the Lender to verify the Borrower’s identity or to comply with any applicable law or regulation.
**Section 8.8 Permits.**Permit any revocation, limitation, suspension or modification of any Permit in any case that would reasonably be expected to result in a Material Adverse Event.
Section 8.9 Useof Lender’s Name. Use the Lender’s name or that of any affiliate of the Lender, including without limitation, the name “Medtronic” in a public disclosure or marketing materials without the prior written consent of the Lender except (i) as may be appropriate or required in any report, statement or testimony submitted to any Governmental Authority having or claiming jurisdiction over the Borrower, (ii) if required or appropriate in any summons or subpoena or in connection with any litigation, to the extent permitted or deemed advisable by Borrower's counsel, or (iii) to comply with any legal requirement or law applicable to the Borrower or demanded by any Governmental Authority; provided, however, that, in the case of disclosures or materials prepared in connection with subsections (i), (ii) and (iii), to the extent permitted by applicable law or regulation, the Borrower shall provide the Lender with a copy of the proposed text of such disclosure or marketing material(s) reasonably in advance of the scheduled date of its release (or provision to any third party, as the case may be) to afford the Lender a reasonable opportunity to review and comment upon the proposed text.
Section 8.10 Indebtedness. Create, incur (or seek to create or incur), assume or be liable for any Indebtedness other than Permitted Indebtedness.
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Section 8.11 Dispositions. Convey, sell, lease, transfer, assign or otherwise dispose of, all or a material portion of its Intellectual Property in violation of the Senior Obligations unless in connection with such conveyance, sale, lease, transfer, assignment or other disposition the Obligations are Satisfied.
Section 8.12 Creationof Subsidiaries. Create or acquire any Subsidiary in violation of the Senior Obligations.
Section 8.13 AffiliateTransaction. Directly or indirectly enter into or permit to exist any transaction with any Affiliate of the Borrower except for transactions that are in the ordinary course of the Borrower’s business or are upon fair and reasonable terms that are no less favorable to the Borrower than would be obtained in an arm’s length transaction with a nonaffiliated Person.
Article 9
EVENTSOF DEFAULT AND REMEDIES
Section 9.1 Eventsof Default. Unless the Lender shall otherwise expressly consent in writing, from the date of this Agreement and thereafter until the Obligations are Satisfied, the continuation of any one or more of the following events, shall constitute an Event of Default:
(a) The Borrower shall fail to make when due, whether by acceleration or otherwise, any payment of principal of the Note, or any interest on the Note, or any fee or other amount required to be made to the Lender pursuant to the Loan Documents; provided, however, that an Event of Default shall not occur on account of a failure to pay due solely to an administrative or operational error of the Lender or the Borrower’s bank if the Borrower had the funds to make the payment when due and makes the payment within three (3) Business Days following the Borrower’s Knowledge of such failure to pay; or
(b) Any representation or warranty made or deemed to have been made by or on behalf of the Borrower or a Credit Party in the Loan Documents or on behalf of the Borrower or a Credit Party in any certificate, statement, report or other writing furnished by or on behalf of the Borrower or a Credit Party to the Lender pursuant to the Loan Documents shall prove to have been false or misleading in any material respect on the date as of which the facts set forth are stated or certified or deemed to have been stated or certified and, if capable of being remedied, such incorrect statement persists for a period of more than three (3) Business Days following the earlier of Knowledge of the Borrower of such incorrect statement and the provision of notice of such incorrect statement to the Borrower by the Lender; or
(c) The Borrower or a Credit Party shall fail to comply with any agreement, covenant, condition, provision or term contained in the Loan Documents and such failure shall continue for at least 30 days; or
(d) An Act of Bankruptcy shall occur with respect to the Borrower or a Credit Party, or any one or more of them; or
(e) A judgment or judgments for the payment of money in excess of the sum of $250,000 in the aggregate shall be rendered against the Borrower or any other Credit Party and the Borrower or such other Credit Party shall not pay or discharge the same or provide for its discharge in accordance with its terms, or procure a stay of execution thereof, prior to any execution on such judgments by such judgment creditor, within 30 days from the date of entry thereof, and within said period of 30 days, or such longer period during which execution of such judgment shall be stayed, appeal therefrom and cause the execution thereof to be stayed during such appeal; or
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(f) Any material portion of the Collateral shall be garnished or attached in any proceeding and such garnishment or attachment shall remain undischarged for a period of 60 days during which execution is not effectively stayed; or
(g) The maturity of any Indebtedness (other than Permitted Indebtedness) of the Borrower or any other Credit Party owed to the Lender, or the maturity of any Indebtedness of the Borrower or any other Credit Party in excess of five hundred thousand dollars ($500,000) shall be accelerated, or the Borrower or any other Credit Party shall fail to pay any such Indebtedness when due or, in the case of such Indebtedness payable on demand, when demanded, and all cure periods related thereto have expired and such debt has been accelerated, or any event shall occur or condition shall exist and shall continue for more than the period of grace, if any, applicable thereto and the Lender or the holder of any such Indebtedness (or any trustee or other Person acting on behalf of such holder) shall have caused such Indebtedness to become due prior to its stated maturity; or
(h) The occurrence of any Material Adverse Event; or
(i) Any material provision of any Loan Document shall for any reason cease to be valid and binding on or enforceable against any Credit Party or any Subsidiary of any Credit Party thereto or any Credit Party or any Subsidiary of any Credit Party shall so state in writing or bring an action to limit its obligations or liabilities thereunder; or
(j) Any Security Document shall for any reason (other than pursuant to the terms thereof or an action on the part of the Lender) cease to create a valid security interest in a material portion of the Collateral purported to be covered thereby or such security interest shall for any reason cease to be a perfected security interest (subject only to Permitted Liens); or
(k) The License Agreement is terminated or ceases, for any reason, to be in full force and effect (other than as agreed in writing by Lender, in accordance with its express terms or as caused by the actions or inactions of Lender).
Section 9.2 Remedies. If (a) any Event of Default described in Section 9.1(d) shall occur, the outstanding unpaid principal balance of the Note, the accrued interest thereon and all other obligations of the Borrower to the Lender under the Loan Documents shall automatically become immediately due and payable and any and all commitments of the Lender to the Borrower to make the Loan to the extent not yet previously funded shall automatically and immediately terminate; or (b) any other Event of Default shall occur and be continuing, then the Lender may take any or all of the following actions: (i) terminate any and all commitments to Borrower to make the Loan to the extent not yet previously funded; or (ii) declare that the outstanding unpaid principal balance of the Note, the accrued and unpaid interest thereon and all other obligations of the Borrower to the Lender under the Loan Documents to be forthwith due and payable, whereupon the Note, all accrued and unpaid interest thereon and all such obligations shall immediately become due and payable, in each case without further demand or notice of any kind, all of which are hereby expressly waived, anything in this Agreement or in the Note to the contrary notwithstanding. In addition, during the continuance of any Event of Default, the Lender may exercise all rights and remedies under the Loan Documents and enforce all rights and remedies under any applicable law.
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Section 9.3 Offset. In addition to the remedies set forth in this Agreement, the Lender or any other holder of the Note may offset any and all credits or monies of the Borrower held by the Lender or such holder, or any obligations of the Lender or such holder to the Borrower, against the Indebtedness then owed by the Borrower to the Lender or such other holder, as applicable. Nothing in this Agreement shall be deemed a waiver or prohibition of the Lender’s rights of offset, or counterclaim, which right the Borrower hereby grants to the Lender.
Article 10
Representationsof Lender
Section 10.1 SecuritiesLaw Compliance. The Lender has been advised that the Note: (i) has not been registered under the Securities Act, or any state securities laws and, therefore, cannot be resold unless they are registered under the Securities Act and applicable state securities laws or unless an exemption from such registration requirements is available. The Lender is aware that the Borrower is under no obligation to effect any such registration with respect to the Note or comply with any exemption from registration. Lender has not been formed solely for the purpose of making this investment and is purchasing the Note to be acquired by the Lender hereunder for its own account for investment, not as a nominee or agent, and not with a view to, or for resale in connection with, the distribution thereof, and the Lender has no present intention of selling, granting any participation in, or otherwise distributing the same. The Lender has such knowledge and experience in financial and business matters that the Lender is capable of evaluating the merits and risks of such investment, is able to incur a complete loss of such investment without impairing the Lender’s financial condition and is able to bear the economic risk of such investment for an indefinite period of time. The Lender is an “accredited investor” as such term is defined in Rule 501 of Regulation D under the Securities Act and shall submit to the Borrower such further assurances of such status as may be reasonably requested by the Borrower.
Article 11
MISCELLANEOUS
Section 11.1 Waiverand Amendment. No failure on the part of the Lender to exercise and no delay in exercising any power or right hereunder or under any other Loan Document shall operate as a waiver thereof; nor shall any single or partial exercise of any power or right preclude any other or further exercise thereof or the exercise of any other power or right. The remedies herein and in any other instrument, document or agreement delivered or to be delivered to the Lender hereunder or in connection herewith are cumulative and not exclusive of any remedies provided by law. No notice to or demand on the Borrower not required hereunder or under the Note shall in any event entitle the Borrower to any other or further notice or demand in similar or other circumstances or constitute a waiver of the right of the Lender or the holder of the Note to any other or further action in any circumstances without notice or demand. All amendments or modifications to this Agreement must be in writing and signed by both the Lender and the Borrower. Notwithstanding anything to the contrary contained herein, no waiver of any provision of this Agreement or consent to any departure by the Borrower therefrom shall be effective unless the same shall be in writing and signed by the Lender, and then such waiver or consent shall be effective only in the specific instances and for the specific purpose for which given.
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Section 11.2 Confidentiality;Public Announcements. Subject to the prior review and approval of the Borrower, the Lender and/or the Lender’s Affiliates may issue any press release(s) or public announcement(s) concerning the existence or any terms of this Agreement or the other Loan Documents or the transactions contemplated hereby or thereby. The Borrower shall not disclose the existence or terms of this Agreement or the other Loan Documents or the transactions contemplated hereby or thereby without the Lender’s prior written consent except (x) as required or requested by any Governmental Authority or reasonably believed by the Borrower to be compelled by any court decree, subpoena or legal or administrative order or process, provided that the Borrower uses reasonable efforts to give the Lender reasonable advance notice of such required disclosure; or (y) to the board of directors, committees, stockholders, or members of Borrower; or (z) as, on the advice of the Borrower’s counsel is required by law. The obligations of the Borrower under this Section 11.2 shall survive indefeasible payment or satisfaction in full of the Obligations.
Section 11.3 Notices. Any notice or other communication to the Borrower in connection with this Agreement and the Loan Documents shall be in writing and shall be sent by manual delivery, email transmission, overnight courier or mail (postage prepaid) addressed to:
Orchestra BioMed Holdings, Inc.
150 Union Square Drive
New Hope, PA 18938
Attention: David P. Hochman, Chief Executive Officer
Email: [Omitted Pursuant to Item 601(a)(6)]
with copies, which shall not constitute notice, to:
Paul Hastings LLP
200 Park Avenue
New York, NY 10166
Attention: Samuel A. Waxman
Email: [Omitted Pursuant to Item 601(a)(6)]
or at such other address as the Borrower shall have specified to the Lender in writing. Any notice or other communication to the Lender in connection with this Agreement and the Loan Documents shall be in writing and shall be sent by manual delivery, email transmission, overnight courier or mail (postage prepaid) addressed to:
Medtronic, Inc.
Medtronic Operational Headquarters
710 Medtronic Parkway
Minneapolis, Minnesota 55432-5604
| Attention: | Chris Eso, VP Corporate Development |
|---|---|
| Peter Shimabukuro, BD Legal | |
| Email: | [Omitted Pursuant to Item 601(a)(6)] |
| [Omitted Pursuant to Item 601(a)(6)] |
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with a copy to (which shall not constitute notice):
Fredrikson & Byron, P.A.
200 South Sixth Street, Suite 4000
Minneapolis, MN 55402
Attention: Christopher J. Melsha and Amanda Welters
Email: [Omitted Pursuant to Item 601(a)(6)]
or at such other address(es) as the Lender shall have specified to the Borrower in writing. All periods of notice shall be measured from the date of delivery thereof if manually delivered (or if such date is not a Business Day, the first Business Day after such delivery), from the date of sending thereof if sent by email during normal business hours and no automatic failure of delivery is received, from the first Business Day after the date of sending if sent by overnight courier, or from four days after the date of mailing (or if such date is not a Business Day, the first Business Day after the date of mailing). If notice to the Borrower of any intended disposition of any collateral or any other intended action is required by law in a particular instance, such notice shall be deemed commercially reasonable if given at least ten days prior to the date of intended disposition or other action.
Section 11.4 Indemnification. The Borrower shall hold harmless the Lender and its Affiliates, and each such Person’s respective officers, directors, employees, attorneys, agents and representatives (each, an “Indemnified Person”), from and against any and all third-party claims, costs, damages, losses, liabilities and expenses (including such claims, costs, damages, losses, liabilities and expenses based on liability in tort, including strict liability in tort), including reasonable attorneys’ fees and disbursements and other costs of investigation or defense (including those incurred upon any appeal) (collectively, “Liabilities”) that may be instituted or asserted against or incurred by any such Indemnified Person as the result of a credit having been extended, suspended or terminated under this Agreement and the other Loan Documents or the administration of such credit, or in connection with or arising out of the transactions contemplated hereunder and thereunder, or any actions or failures to act in connection therewith, or arising out of the disposition or utilization of the Collateral, excluding in all cases Liabilities to the extent such Liabilities arise solely out of gross negligence or willful misconduct of any Indemnified Person. NO INDEMNIFIED PERSON SHALL BE RESPONSIBLE OR LIABLE TO ANY OTHER PARTY TO ANY LOAN DOCUMENT, ANY SUCCESSOR, ASSIGNEE OR THIRD PARTY BENEFICIARY OF SUCH PERSON OR ANY OTHER PERSON ASSERTING CLAIMS DERIVATIVELY THROUGH SUCH PARTY, FOR INDIRECT, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES WHICH MAY BE ALLEGED AS A RESULT OF CREDIT HAVING BEEN EXTENDED, SUSPENDED OR TERMINATED UNDER ANY LOAN DOCUMENT OR AS A RESULT OF ANY OTHER TRANSACTION CONTEMPLATED HEREUNDER OR THEREUNDER. The obligations of the Borrower under this Section 11.4 shall survive after the Obligations are Satisfied.
Section 11.5 MultipleAgreements. Notwithstanding the fact that this Agreement is one of a series of agreements entered into by the parties on the date hereof, the parties acknowledge and agree that the entry into this Agreement, and the performance of their obligations hereunder, is not an inducement to enter into any other of such agreements, and that the entry into any other such agreements, or the performance thereunder, is not an inducement to enter into this Agreement.
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Section 11.6 Successors. This Agreement and the other Loan Documents shall be binding on the Borrower and the Lender and their respective successors and assigns and shall inure to the benefit of the Borrower and the Lender, and the successors and assigns of the Borrower and the Lender. Neither party shall assign its rights or duties hereunder or under any other Loan Document without the written consent of the other parties, as applicable; provided, however, the Lender may assign its rights or duties hereunder to one of its Affiliates without the written consent of the Borrower.
Section 11.7 Severability. Any provision of this Agreement which is prohibited or unenforceable in any jurisdiction shall, in such jurisdiction, be ineffective to the extent of such prohibition or unenforceability without invalidating the remaining provisions hereof or affecting the validity or enforceability of such provision in any other jurisdiction.
Section 11.8 Captions. The captions or headings herein are for convenience only and in no way define, limit or describe the scope or intent of any provision of this Agreement.
Section 11.9 EntireAgreement. This Agreement, the Note, and the other Loan Documents, embody the entire agreement and understanding between the Borrower and the Lender with respect to the subject matter hereof and thereof.
Section 11.10 Counterparts. This Agreement may be executed in any number of counterparts, and transmitted via facsimile or other electronic transmission, all of which taken together shall constitute one and the same instrument, and either of the parties hereto may execute this Agreement by signing any such counterpart.
Section 11.11 GoverningLaw and Construction. THE VALIDITY, CONSTRUCTION AND ENFORCEABILITY OF THIS AGREEMENT AND THE NOTE SHALL BE GOVERNED BY THE INTERNALLAWS OF THE STATE OF NEW YORK, WITHOUT GIVING EFFECT TO CONFLICTS OF LAWS PRINCIPLES THEREOF. Whenever possible, each provision of this Agreement and the other Loan Documents and any other statement, instrument or transaction contemplated hereby or thereby or relating hereto or thereto shall be interpreted in such manner as to be effective and valid under such applicable law, but, if any provision of this Agreement, the other Loan Documents or any other statement, instrument or transaction contemplated hereby or thereby or relating hereto or thereto shall be held to be prohibited or invalid under such applicable law, such provision shall be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of such provision or the remaining provisions of this Agreement, the other Loan Documents or any other statement, instrument or transaction contemplated hereby or thereby or relating hereto or thereto.
Section 11.12 ExclusiveJurisdiction. ALL DISPUTES ARISING FROM THIS AGREEMENT AND THE OTHER LOAN DOCUMENTS SHALL BE SUBJECT TO THE SOLE AND EXCLUSIVE JURISDICTIONOF THE COURTS of the STATE OF NEW YORK OR of the United States of America sitting in the cityof NEW YORK, AND THE BORROWER CONSENTS TO THE JURISDICTION AND VENUE OF ANY SUCH COURT AND WAIVES ANY ARGUMENT THAT VENUE IN SUCHFORUMS IS NOT CONVENIENT. IN THE EVENT THAT THE BORROWER COMMENCES ANY ACTION IN ANY JURISDICTION OR VENUE UNDER ANY TORT OR CONTRACTTHEORY ARISING DIRECTLY OR INDIRECTLY FROM THE RELATIONSHIP CREATED BY THIS AGREEMENT, THE LENDER AT ITS OPTION SHALL BE ENTITLED TO HAVETHE CASE TRANSFERRED TO ONE OF THE JURISDICTIONS AND VENUES ABOVE-DESCRIBED, OR IF SUCH TRANSFER CANNOT BE ACCOMPLISHED UNDER APPLICABLELAW, TO HAVE SUCH CASE DISMISSED WITHOUT PREJUDICE.
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Section 11.13 Waiverof Jury Trial. EACH OF THE BORROWER AND THE LENDER IRREVOCABLY WAIVES ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISINGOUT OF OR RELATING TO THIS AGREEMENT OR ANY OTHER LOAN DOCUMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY OR THEREBY.
Section 11.14 Acknowledgments. The Borrower hereby acknowledges that (a) each has been advised by counsel in the negotiation, execution and delivery of this Agreement and the other Loan Documents, (b) the Lender has no fiduciary relationship to the Borrower, the relationship being solely that of debtor and creditor, (c) no joint venture exists between the Lender, on one hand, and the Borrower on the other hand, and (d) the Lender undertakes no responsibility to the Borrower to review or inform the Borrower of any matter in connection with any phase of the business or operations of the Borrower and the Borrower shall rely entirely upon their own judgment with respect to the Borrower’s business, and any review, inspection or supervision of, or information supplied to, the Borrower by the Lender is for the protection of the Lender and neither the Borrower nor any third party is entitled to rely thereon.
Section 11.15 Jointand Several Liability. Each Borrower acknowledges that it is jointly and severally liable for all of the Obligations and as a result hereby unconditionally guaranties the full and prompt payment when due, whether at maturity or earlier, by reason of acceleration or otherwise, and at all times thereafter, of all Obligations of every kind and nature of each other Borrower to the Lender, howsoever created, arising or evidenced, whether direct or indirect, absolute or contingent, joint or several, now or hereafter existing, or due or to become due, and howsoever owned, held or acquired by the Lender. Each Borrower agrees that if this guaranty, or any Liens securing this guaranty, would, but for the application of this sentence, be unenforceable under applicable law, this guaranty and each such Lien shall be valid and enforceable to the maximum extent that would not cause this guaranty or such Lien to be unenforceable under applicable law, and this guaranty shall automatically be deemed to have been amended accordingly at all relevant times. Each Borrower hereby agrees that its obligations under this guaranty shall be unconditional, irrespective of (a) the validity or enforceability of the Obligations or any part thereof, or of any promissory note or other document evidencing all or any part of the Obligations, (b) the absence of any attempt to collect the Obligations from any other Borrower or any guarantor or other action to enforce the same, (c) the waiver or consent by the Lender or any other Person with respect to any provision of any agreement, instrument or document evidencing or securing all or any part of the Obligations, or any other agreement, instrument or document now or hereafter executed by any other Borrower and delivered to the Lender or any other Person (other than a waiver, forgiveness or consent by the Lender or other Person, as applicable, that reduces the amount of any of the Obligations to such Person), (d) the failure by the Lender or any other Person to take any steps to perfect and maintain its security interest in, or to preserve its rights to, any security or Collateral for the Obligations, for its benefit, (e) the Lender’s election, in any proceeding instituted under the Bankruptcy Code or any other similar bankruptcy or insolvency legislation, of the application of Section 1111(b)(2) of the Bankruptcy Code or any other similar bankruptcy or insolvency legislation, (f) any borrowing or grant of a security interest by any Borrower as debtor-in-possession, under Section 364 of the Bankruptcy Code or any other similar bankruptcy or insolvency legislation, (g) the disallowance, under Section 502 of the Bankruptcy Code or any other similar bankruptcy or insolvency legislation, of all or any portion of the Lender’s claim(s) for repayment of the Obligations or (h) any other circumstance which might otherwise constitute a legal or equitable discharge or defense of a Borrower or a guarantor (other than payment in full of the Obligations). Notwithstanding anything to the contrary set forth in this Section 11.16, it is the intent of the parties hereto that the liability incurred by each Borrower in respect of the Obligations of the other Borrowers (and any Lien granted by each Borrower to secure such Obligations), not constitute a fraudulent conveyance under Section 548 of the Bankruptcy Code or a fraudulent conveyance or fraudulent transfer under the provisions of any applicable law of any state or other governmental unit (“Fraudulent Conveyance”). Consequently, each Borrower and the Lender hereby agree that if a court of competent jurisdiction determines that the incurrence of liability by any Borrower in respect of the Obligations of any other Borrower (or any Liens granted by such Borrower to secure such Obligations) would, but for the application of this sentence, constitute a Fraudulent Conveyance, such liability (and such Liens) shall be valid and enforceable only to the maximum extent that would not cause the same to constitute a Fraudulent Conveyance, and this Agreement and the other Loan Documents shall automatically be deemed to have been amended accordingly.
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Section 11.16 BorrowerRepresentative. Each Borrower hereby designates Parent as its representative and agent on its behalf (in such capacity, “Borrower Representative”) for the purposes of selecting interest rate options, giving and receiving all other notices and consents hereunder or under any of the other Loan Documents and taking all other actions (including in respect of compliance with covenants) on behalf of any Borrower or the Borrowers under the Loan Documents. Parent hereby accepts such appointment. Notwithstanding anything to the contrary contained in this Agreement, no Borrower other than Borrower Representative shall be entitled to take any of the foregoing actions. The Lender may regard any notice or other communication pursuant to any Loan Document from Borrower Representative as a notice or communication from all of the Borrowers, and may give any notice or communication required or permitted to be given to any Borrower or all of the Borrowers hereunder to Borrower Representative on behalf of such Borrower or all of the Borrowers. Each Borrower agrees that each notice, election, representation and warranty, covenant, agreement and undertaking made on its behalf by Borrower Representative (in such capacity) shall be deemed for all purposes to have been made by such Borrower and shall be binding upon and enforceable against such Borrower to the same extent as if the same had been made directly by such Borrower.
Article 12
SECURITYINTEREST
Section 12.1 Grantof Security Interest. As security for the performance by the Borrower of all the terms, covenants and agreements on the part of the Borrower to be performed under this Agreement and the other Transaction Documents, including the punctual payment when due of each obligation of the Borrower hereunder, each Borrower grants to Lender a security interest in all of such Borrower’s right, title, and interests in, the Product Collateral and all Proceeds (as defined in the UCC) of the foregoing, whether now owned or hereafter acquired (collectively, the “Collateral”).
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Section 12.2 FurtherAssurances.
(a) The Borrower shall, from time to time, execute, deliver and file any financing statements, IP Security Agreements, other security agreements, notices or other documents to perfect, give the highest priority to the Lender’s Lien on the Collateral (other than any Lien expressly permitted by clause (a) of the definition of “Permitted Liens” and solely to the extent contemplated by and subject to the Senior Intercreditor Agreement and Ligand Intercreditor Agreement) or otherwise evidence the Lender’s rights herein. The Borrower shall from time to time procure any instruments or other documents as may be reasonably requested by the Lender and take all further action that may be necessary or advisable that the Lender may reasonably request, to perfect and protect the Liens granted hereby. In addition, and for such purposes only, the Borrower hereby authorizes the Lender to execute and deliver on behalf of Borrower and to file such financing statements, IP Security Agreements, security agreements, notices or other documents without the signature of the Borrower either in Lender’s name or in the name of Lender, as agent and attorney-in-fact for the Borrower. The Borrower shall protect and defend the Borrower’s title to the Collateral and Lender’s Lien thereon against all Persons claiming any interest adverse to the Lender or Borrower other than Liens in respect of the Senior Obligations or the Ligand Obligations.
(b) On or before the Closing Date, the Borrower will execute and deliver to the Lender such patent and trademark security agreements as the Lender may reasonably request, on the form set forth hereto as Exhibit C (each an “IP Security Agreement”) and will record such agreements with the U.S. Patent and Trademark Office. Within forty-five (45) days of the last day of the fiscal quarter during which the Closing Date occurred and each fiscal quarter ending thereafter, the Borrower will notify the Lender in writing of the creation or acquisition of any Intellectual Property Rights owned by the Borrower or its Subsidiaries that are registered or become registered or the subject of an application for registration with the U.S. Patent and Trademark Office, in each case during such fiscal quarter then ended and will record a further IP Security Agreement in the form attached as Exhibit C or an amendment to an existing IP Security Agreement in form and substance reasonably acceptable to the Lender with the U.S. Patent and Trademark Office, and will take such other action as may be necessary or as the Lender may reasonably request to perfect the Lender’s security interest in such Intellectual Property Rights.
Section 12.3 Remedies. Upon the occurrence and during the continuation of an Event of Default, subject in all cases to the Senior Intercreditor Agreement and Ligand Intercreditor Agreement, the Lender shall have the rights and remedies of a secured party under the UCC in effect on the date thereof including, without limitation, the right to take possession of any of the Product Collateral or the proceeds thereof, to sell or otherwise dispose of the same, to apply the proceeds therefrom to any of the Obligations in such order as Lender, in its sole discretion, may elect. Lender shall give Borrower reasonable written notice of the time and place of any public sale of the Product Collateral or the time after which any other intended disposition thereof is to be made. The requirement of sending reasonable notice shall be met if such notice is given to Borrower at least ten (10) days before such disposition. Expenses of retaking, holding, insuring, preserving, protecting, preparing for sale or selling or the like with respect to the Product Collateral (including reasonable attorney’s fees and other legally recoverable collection expenses) will constitute Obligations hereunder.
(The signature page follows.)
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THE PARTIES HERETO have caused this Loan Agreement to be executed as of the date set forth above.
| BORROWERS: | |
|---|---|
| ORCHESTRA<br> BIOMED HOLDINGS, INC. | |
| By: | /s/ David P. Hochman |
| Name: | David P. Hochman |
| Title: | Chief Executive Officer |
| ORCHESTRA<br> BIOMED, INC. | |
| By: | /s/ David P. Hochman |
| Name: | David P. Hochman |
| Title: | Chief Executive Officer |
| CALIBER<br> THERAPEUTICS, LLC | |
| By: | /s/ David P. Hochman |
| Name: | David P. Hochman |
| Title: | Chief Executive Officer |
| BackBeat<br> Medical, LLC | |
| By: | /s/ David P. Hochman |
| Name: | David P. Hochman |
| Title: | Chief Executive Officer |
[SIGNATURE PAGE TO LOAN AGREEMENT]
| LENDER: | |
|---|---|
| MEDTRONIC, INC. | |
| By: | /s/ Chris Eso |
| Name: | Chris Eso |
| Title: | VP, Corporate Development & Ventures |
[SIGNATURE PAGE TO LOAN AGREEMENT]
SCHEDULE 6.1
Capitalization of the Borrower
SCHEDULE 6.9
Claims Related to Intellectual Property
Exhibit 10.4
EXECUTION VERSION
THIS NOTE HAS NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR ANY OTHER APPLICABLE SECURITIES LAWS AND MAY NOT BE REOFFERED, SOLD, TRANSFERRED, PLEDGED, OR OTHERWISE DISPOSED OF EXCEPT PURSUANT TO (1) REGISTRATION UNDER SUCH ACT AND ANY OTHER APPLICABLE LAWS OR (2) AN OPINION OF COUNSEL FOR THE BORROWER OR OTHER COUNSEL REASONABLY ACCEPTABLE TO THE BORROWER TO THE EFFECT THAT SUCH REGISTRATION IS NOT REQUIRED.
SECURED SUBORDINATED PROMISSORY NOTE
| $20,000,000.00 | April 27, 2026 |
|---|
FOR VALUE RECEIVED, ORCHESTRA BIOMED HOLDINGS, INC., a Delaware corporation (the “Parent”), ORCHESTRA BIOMED, INC., a Delaware corporation (“Orchestra”), CALIBER THERAPEUTICS, LLC, a Delaware limited liability company (“Caliber”), BACKBEAT MEDICAL, LLC, a Delaware limited liability company (“BackBeat,” and collectively with Parent, Caliber and Orchestra, the “Borrower”), promises to pay to the order of MEDTRONIC, INC., a Minnesota corporation, or its successors and permitted assigns (the “Holder”), at the office of 710 Medtronic Parkway, Minneapolis, MN 55432-5604 or at such other place as the Holder may designate in writing, the principal sum, in lawful money of the United States of America, of TWENTY MILLION Dollars ($20,000,000.00) or so much thereof as may be advanced pursuant to the terms and conditions of that certain Loan Agreement, dated as of July 31, 2025, entered into by and between the Borrower and the Holder (as amended from time to time, the “Agreement”) together with simple interest on the unpaid principal balance hereof from the date hereof until this Note is fully paid, at an annual rate of interest, calculated on the basis of actual number of days elapsed in a 365-day year, that shall at all times be equal to the Interest Rate (or the Default Rate, as applicable), as provided in the Agreement.
This Note is the “Note” referred to in the Agreement, is issued pursuant to and is subject to the Agreement which, among other things, provides for acceleration of the maturity hereof upon the occurrence of an Event of Default.
1. Definitions. Capitalized terms not otherwise defined herein shall have the meanings set forth in the Agreement.
2. Payment of Principal and Interest. If and to the extent that the principal balance of this Note, together with all accrued and unpaid interest thereon (collectively, the “Balance”), is not automatically converted into the Royalty Credit pursuant to Section 3 hereof, then the Balance shall be due and payable in full on the Repayment Date.
3. Automatic Conversion into Revenue Share Credit.
(a) If FDA Approval (as defined below) is achieved on any date prior to the Repayment Date, and this Note remains outstanding on such date, the Balance of this Note as of such date shall automatically convert into the Revenue Share Credit as defined and described on Appendix A attached hereto. For purposes of this Note, “FDA Approval” means the regulatory approval by the FDA of a PMA as defined in 21 C.F.R. 814 and the related FDA guidance documents (“PMA”) application or supplemental application with respect to a Lender transvenous pacing system medical device that incorporates certain cardiac neuromodulation therapy algorithms (BackBeat CNT Algorithms) of the Borrower (also known as Atrioventricular Interval Modulation therapy or AVIM therapy) for the treatment of hypertension.
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(b) All rights and obligations with respect to this Note (other than the obligation of the Borrower to pay the Revenue Share Credit) and all rights and obligations under the Agreement (other than unmatured contingent indemnification and reimbursement obligations that expressly survive termination) shall terminate upon conversion of this Note pursuant to this Section 3 and the entire Balance of this Note will be cancelled whether or not this Note is surrendered.
4. Security. The Obligations arising under this Note are secured pursuant to the Security Agreement.
5. Subordination. The Holder hereby covenants and agrees that the payment of all obligations owed by the Borrower to the Holder arising under this Note (collectively, the “Junior Obligations”) will be subordinate in right of payment to the prior payment in full in cash of the Senior Obligations pursuant to the terms of the Subordination Agreement (as such term is defined in the Agreement).
6. Loss or Mutilation of Note. Upon receipt by the Borrower of evidence satisfactory to the Borrower of the loss, theft, destruction or mutilation of this Note, together with an indemnity reasonably satisfactory to the Borrower, in the case of loss, theft, or destruction, or the surrender and cancellation of this Note, in the case of mutilation, the Borrower shall execute and deliver to the Holder a new Note of like tenor and denomination as this Note.
7. Costs of Collection. The Borrower agrees to pay all costs of collection, including reasonable attorneys’ fees, in the event this Note is not paid when due as provided in the Agreement.
8. Waivers. The Borrower hereby waives presentment, demand for payment, notice of dishonor, and all other notices or demands in connection with the delivery, acceptance, performance, default or endorsement of this Note. The failure of the Holder to enforce at any time any of the provisions of this Note shall not, absent an express written waiver signed by the Holder, be construed to be a waiver of any such provisions, nor in any way to affect the validity of this Note or any part hereof or the right of the Holder thereafter to enforce each and every such provision. No waiver or any breach of this Note shall be held to a waiver of any other or subsequent breach.
9. Miscellaneous. The titles and headings to the Sections herein are inserted for the convenience of reference only and are not intended to be a part of or to affect the meaning or interpretation of this Note. This Note shall be construed without regard to any presumption or other rule requiring construction hereof against the party causing this Note to be drafted.
10. Amendment. No amendment, modification or waiver of any provision of this Note shall be effective unless the same shall be in writing and signed by the Borrower and by the Holder.
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11. Governing Law. This Note is being delivered in, and shall be governed by, the laws of the State of New York without giving effect to conflicts of laws principles thereof.
12. Joint and Several. All of the obligations of each Borrower hereunder are joint, several and primary. To the extent that a term or provision of this Note is applicable to “Borrower”, it is applicable to each and every Borrower unless the context expressly indicates otherwise.
[Signature page follows.]
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The Borrower has caused this Secured Subordinated Promissory Note to be executed as of the date first set forth above.
| ORCHESTRA BIOMED HOLDINGS, INC. |
|---|
| By: |
| Name: |
| Title: |
| ORCHESTRA BIOMED, INC. |
| By: |
| Name: |
| Title: |
| CALIBER THERAPEUTICS, LLC |
| By: |
| Name: |
| Title: |
| BACKBEAT MEDICAL, LLC |
| By: |
| Name: |
| Title: |
[SIGNATURE PAGE TO SECURED SUBORDINATED PROMISSORY NOTE]
Agreed and accepted:
| HOLDER: |
|---|
| MEDTRONIC, INC. |
| By: |
| Name: |
| Title: |
[SIGNATURE PAGE TO SECURED SUBORDINATED PROMISSORY NOTE]
APPENDIX A
Revenue Share Credit
| 1. | Orchestra BioMed, BackBeat (together with<br> Orchestra BioMed, the “Licensor Borrowers”) and Holder are parties to<br> that certain Exclusive License and Collaboration Agreement dated as of June 30, 2022,<br> as amended (the “License Agreement”). Capitalized terms not otherwise<br> defined in the Note, the Agreement or herein shall have the meanings ascribed to them in<br> the License Agreement. |
|---|---|
| 2. | Pursuant to the terms and conditions of the<br> License Agreement, the Licensor Borrowers are entitled to receive a Revenue Share on Net<br> Sales of Products during the Term. |
| --- | --- |
| 3. | Upon conversion of the Balance in accordance<br> with Section 3 of the Note, the Licensor Borrowers shall pay to Holder an amount equal<br> to fifteen percent (15%) of all Revenue Share Amounts that the Licensor Borrowers receive<br> under the License Agreement (the “Revenue Share Credit”), until such time<br> as the total amount of Revenue Share Credit payments equals $40,000,000 (the “Revenue<br> Share Cap”). Upon payment to the Holder of an aggregate amount equal to the Revenue<br> Share Cap, the Revenue Share Credit and the Holder's right to receive payments hereunder<br> shall automatically terminate. |
| --- | --- |
| 4. | The Licensor Borrowers shall make Revenue<br> Share Credit payments to Holder within thirty (30) Business Days following the end of the<br> calendar quarter in which any payment of a Revenue Share Amount was received by the Licensor<br> Borrowers. All amounts specified to be payable hereunder are in U.S. dollars and shall be<br> paid in U.S. dollars. All payments hereunder shall be made by bank wire transfer in immediately<br> available funds to an account designated in writing by Holder or by such other means as directed<br> by Holder in writing. Payments hereunder will be considered to be made as of the day on which<br> they are received by Holder’s designated bank. |
| --- | --- |
| 5. | The Licensor Borrowers shall maintain records<br> in sufficient detail necessary for the calculation and verification of all Revenue Share<br> Credit amounts due to the Licensor Borrowers hereunder for a period of three years following<br> the receipt of any Revenue Share Amounts. |
| --- | --- |
| 6. | In addition to any other remedies that may<br> be available to the Holder under contract, or at law or equity, to the extent that any Revenue<br> Share Credit payments referred to above are not received timely by Holder in accordance with<br> the terms hereof, Holder shall have the right to offset such unpaid amount against future<br> payments that may be owed to any Borrower or its Affiliates. |
| --- | --- |
Exhibit 10.5
Execution Version
STOCK PURCHASE AGREEMENT
This STOCK PURCHASE AGREEMENT (this “Agreement”) is dated as of July 31, 2025, by and between Orchestra BioMed Holdings, Inc., a Delaware corporation (the “Issuer”) and Covidien Group S.à.r.l., a private limited liability company (société à responsabilité limitée), incorporated under the laws of the Grand Duchy of Luxembourg (the “Investor”).
W I T N E S S E T H:
WHEREAS, the Issuer and the Investor are executing and delivering this Agreement in reliance upon the exemption from securities registration afforded by Section 4(a)(2) of the U.S. Securities Act of 1933, as amended (the “Securities Act”);
WHEREAS, the Investor, wishes to purchase, and the Issuer wishes to issue and sell, upon the terms and conditions stated in this Agreement, an aggregate of up to $12,000,000 of shares of the Issuer’s common stock, par value $0.0001 per share (“Common Stock”), consisting of (i) $10,000,000 of shares of Common Stock (the “Initial Shares”) and (ii) additional shares of Common Stock (the “Additional Shares” and, together with the Initial Shares, the “Shares”) up to $2,000,000, at a purchase price per share at which the Common Stock is sold to the public in the Issuer’s next underwritten public offering of its Common Stock pursuant to an effective registration statement under the Securities Act (the “Subsequent Offering”), as set forth on the cover page of the prospectus filed in connection with the Subsequent Offering, and such purchase will occur immediately following and shall be conditioned upon, the closing of the Subsequent Offering (the “Closing”);
WHEREAS, the Issuer has engaged Piper Sandler & Co. (“Piper Sandler”) and TD Securities (USA) LLC (“TD Cowen” and together with Piper Sandler, the “Placement Agents”) to act as placement agents in connection with the sale of Shares pursuant to this Agreement; and
WHEREAS, prior to the Closing, the parties hereto shall execute and deliver a Registration Rights Agreement, substantially in the form attached hereto as Exhibit A (the “Registration Rights Agreement,” and together with this Agreement, the “Transaction Agreements”), pursuant to which, among other things, the Issuer will agree to provide certain registration rights with respect to the Shares under the Securities Act and the rules and regulations promulgated thereunder and applicable state securities laws.
NOW THEREFORE, in consideration of the foregoing and the mutual agreements, covenants, provisions and warranties herein contained and for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:
Article I
PURCHASE AND SALE
1.1 Purchase and Sale of Shares. Subject to the (i) terms and conditions set forth in this Agreement and (ii) the receipt by the Issuer of gross proceeds of at least $25,000,000 in the aggregate pursuant to (a) the Subsequent Offering and (b) the terms of a stock purchase agreement between the Issuer and Ligand Pharmaceuticals Incorporated, dated as of the date hereof (the “Ligand Private Placement”), at the Closing, the Issuer agrees to issue and sell to the Investor (x) the Initial Shares plus (y) a number of Additional Shares as determined in accordance with Section 1.2, and the Investor agrees to purchase such number of Shares at a price per share equal to the price at which the Common Stock is sold to the public in the Subsequent Offering, as set forth on the cover page of the prospectus filed in connection with the Subsequent Offering (the “Purchase Price”).
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1.2 Additional Shares. Subject to the terms and conditions of this Agreement, the Investor agrees to purchase such amount of Additional Shares on a proportional basis equal to 0.05714 multiplied by the amount of gross proceeds raised in the Subsequent Offering in excess of $35,000,000, up to a cap of $2,000,000.
1.3 Closing. Subject to satisfaction or waiver of the conditions set forth in Article V of this Agreement, the Closing shall take place on the date of the closing of the Subsequent Offering at the offices of counsel to the Issuer, Paul Hastings LLP located at 200 Park Avenue, New York, New York 10166, or at such other place as the applicable parties to the Closing shall agree in writing.
1.4 Deliveries at Closing.
(a) At the Closing, the Investor shall deliver to Issuer the following:
(i) the Purchase Price by wire transfer of immediately available funds to the account designated by the Issuer in writing; and
(ii) the Registration Rights Agreement, duly executed by the Investor.
(b) At the Closing, the Issuer shall deliver to the Investor the following:
(i) the instruments, consents, certificates and other documents required of the Issuer pursuant to Section 5.2;
(ii) the Shares in book entry form, free and clear of any liens or other restrictions whatsoever (other than those arising under applicable securities laws), registered in the name of Investor (or its nominee in accordance with its delivery instructions); and
(iii) the Registration Rights Agreement, duly executed by the Issuer.
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Article II
REPRESENTATIONS AND WARRANTIES OF THE ISSUER
The Issuer represents and warrants to the Investor and the Placement Agents that the statements contained in this Article II are true and correct as of the date of this Agreement and as of the Closing (except for representations and warranties that speak as of a specific date, which shall be made as of such date):
2.1 Organization and Good Standing. The Issuer is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware, has the requisite power and authority to own, lease and operate its properties and to carry on its business as now conducted and described in the SEC Reports (as defined below) and is qualified to do business in each jurisdiction in which the character of its properties or the nature of its business requires such qualification.
2.2 Capitalization. The Issuer’s disclosure of its authorized, issued and outstanding capital stock in the SEC Reports containing such disclosure was accurate in all material respects as of the date indicated in such SEC Reports. All of the issued and outstanding shares of Common Stock have been duly authorized and validly issued and are fully paid and non-assessable. None of the outstanding shares of capital stock of the Issuer were issued in violation of any preemptive or other similar rights of any securityholder of the Issuer which have not been waived, and such shares were issued in compliance in all material respects with applicable state and federal securities law and any rights of third parties. Except as disclosed in the SEC Reports, there are no outstanding rights (including, without limitation, pre-emptive rights), warrants or options to acquire, or instruments convertible into or exchangeable for, any shares of capital stock or other equity interest in the Issuer or any of its subsidiaries, or any contract, commitment, agreement, understanding or arrangement of any kind relating to the issuance of any capital stock of the Issuer or any such subsidiary, any such convertible or exchangeable securities or any such rights, warrants or options; the capital stock of the Issuer conforms in all material respects to the description thereof contained in the SEC Reports; and all the outstanding shares of capital stock or other equity interests of each subsidiary owned, directly or indirectly, by the Issuer have been duly and validly authorized and issued, are fully paid and non-assessable (except, in the case of any foreign subsidiary, for directors’ qualifying shares) and are owned directly or indirectly by the Issuer, free and clear of any lien, charge, encumbrance, security interest, restriction on voting or transfer or any other claim of any third party.
2.3 Authorization and Validity of Transaction Agreements. The Issuer has all requisite power and authority to execute and deliver the Transaction Agreements, to perform its obligations under the terms of the Transaction Agreements, including the issuance and sale of the Shares, and to consummate the transactions contemplated hereby. The execution and delivery of the Transaction Agreements, the performance by the Issuer of its obligations under the terms of the Transaction Agreements and the consummation of the transactions contemplated thereby, including the issuance and sale of the Shares, have been duly and validly authorized by all requisite corporate action of the Issuer, its officers, directors and stockholders (none of which actions have been modified or rescinded, and all of which actions are in full force and effect). This Agreement has been duly executed and delivered by the Issuer and, assuming the due authorization, execution and delivery by the Investor of this Agreement and that this Agreement constitutes the legal, valid and binding agreement of the Investor, constitutes a legal, valid and binding obligation of the Issuer, enforceable against the Issuer in accordance with its terms, except as such enforceability may be limited or otherwise affected by bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and/or similar laws relating to or affecting the rights of creditors generally or by general equity principles (regardless of whether such enforceability is considered in a proceeding in equity or at law).
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2.4 Title to Shares. The Shares have been duly authorized and upon payment by the Investor of the Purchase Price and delivery by the Issuer of the Shares in “book-entry” form pursuant to the terms hereof, the Shares will be validly issued, fully paid and non-assessable, and the Investor will acquire good and marketable title thereto, free and clear of all mortgages, liens, pledges, charges, claims, security interests and other encumbrances (other than any restrictions created by the Investor or any restrictions created by federal or state securities laws), and shall be entitled to all rights accorded to a holder of Common Stock. The issuance and delivery of the Shares does not (a) obligate the Issuer to offer to issue, or issue, shares of Common Stock or other securities to any person pursuant to any preemptive rights, rights of first refusal, rights of participation or similar rights, or (b) result in any adjustment (automatic, at the election of any person or otherwise) of the exercise, conversion, exchange or reset price under, or any other anti-dilution adjustment pursuant to, any outstanding securities of the Issuer.
2.5 Non-Contravention. The execution and delivery of the Transaction Agreements by the Issuer, the performance by the Issuer of its obligations hereunder and thereunder, and the consummation by the Issuer of the transactions contemplated hereby and thereby do not, and will not as of the Closing, conflict with, contravene, result in a violation or breach of or default under (with or without the giving of notice or the lapse of time, or both), permit any party to terminate, amend or accelerate the provisions of, or result in the imposition of any claim, lien, pledge, deed of trust, option, charge, security interest, hypothecation, encumbrance, right of first offer, voting trust, proxy, right of third parties or other restriction or limitation of any nature whatsoever (each, a “Lien”), or any obligation to create any Lien, upon any of the properties or assets of the Issuer under (i) any contract, agreement, indenture, letter of credit, mortgage, security agreement, pledge agreement, deed of trust, bond, note, guarantee, surety obligation, warranty, license, franchise, permit, power of attorney, lease, instrument or other agreement (each, a “Contract”) to which the Issuer is a party or by which any of its property or assets may be bound, except as would not, individually or in the aggregate, be reasonably expected to have a material adverse effect on the assets, business, results of operation or financial operations of the Issuer and its subsidiaries, taken as a whole, or prevents, impairs, delays or impedes the legal authority of the Issuer to enter into and timely perform in any material respect its obligations under this Agreement (a “Material Adverse Effect”) or (ii) any provision of the organizational documents of the Issuer.
2.6 Consents. Assuming the accuracy of the representations and warranties of the Investor set forth in Article III hereof, no consent, approval, authorization, filing with or order of or registration with, any court or governmental agency or body is required in connection with the authorization, execution or delivery by the Issuer of the Transaction Agreements, the issuance and sale of the Shares and the performance by the Issuer of its other obligations under the Transaction Agreements, except (a) as have been or will be obtained or made under the Securities Act or the Securities Exchange Act of 1934, as amended (the “Exchange Act”), (b) customary post-closing filings with the Securities and Exchange Commission (“SEC”) or pursuant to state securities laws in connection with the offer and sale of the Shares by the Issuer in the manner contemplated herein, which will be filed on a timely basis, (c) the filing of the registration statement required to be filed by the Registration Rights Agreement, (d) notices that may be required by the rules of the Nasdaq Global Market (“Nasdaq”) or (e) such that the failure of which to obtain would not have a Material Adverse Effect. All notices, consents, authorizations, orders, filings and registrations which the Issuer is required to deliver or obtain prior to the Closing pursuant to the preceding sentence have been obtained or made or will be delivered or obtained or effected, and shall remain in full force and effect, on or prior to the Closing.
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2.7 Exemption from Registration; No Integration; No General Solicitation.
(a) Subject to the accuracy of the representations and warranties of the Investor, it is not necessary in connection with the offer, sale and delivery of the Shares to the Investor in the manner contemplated by this Agreement to register the Shares under the Securities Act.
(b) Neither the Issuer nor any affiliate (as defined in Rule 501(b) of Regulation D under the Securities Act) (“Affiliate”) of the Issuer has directly, or through any agent, (i) sold, offered for sale, solicited offers to buy or otherwise negotiated in respect of, any security (as defined in the Securities Act) which is or will be integrated with the sale of the Shares in a manner that would require the registration under the Securities Act of the Shares or (ii) offered, solicited offers to buy or sold the Shares by any form of general solicitation or general advertising (as those terms are used in Regulation D under the Securities Act) or in any manner involving a public offering within the meaning of Section 4(a)(2) of the Securities Act.
2.8 SEC Filings. The Issuer has filed all forms, statements, certifications, reports and documents required to be filed by it with the SEC under Section 13, 14(a) and 15(d) of the Exchange Act for the one year preceding the date of this Agreement and is in compliance with General Instruction I.A.3 of Form S-3. 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 filed SEC Reports complied in all material respects with the applicable requirements of the Exchange Act, and, as of the time they were filed, none of the filed SEC Reports 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. There are no outstanding or unresolved comments from the SEC staff with respect to the SEC Reports. To the Issuer’s knowledge, none of the SEC Reports are the subject of an ongoing SEC review. The interactive data in eXtensible Business Reporting Language included in the SEC Reports fairly presents the information called for in all material respects and has been prepared in accordance with the SEC’s rules and guidelines applicable thereto. As used in this Agreement, “SEC Reports” means (a) the Issuer’s most recently filed Annual Report on Form 10-K and (b) all Quarterly Reports on Form 10-Q or Current Reports on Form 8-K filed or furnished (as applicable) by the Issuer following the end of the most recent fiscal year for which an Annual Report on Form 10-K has been filed and prior to the execution of this Agreement, together in each case with any documents incorporated by reference therein or exhibits thereto.
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2.9 Absence of Litigation. There is no action, suit, proceeding, arbitration, claim, investigation, charge, complaint or inquiry pending or, to the Issuer’s knowledge, threatened against the Issuer or any of its subsidiaries which, individually or in the aggregate, has had or would reasonably be expected to have a Material Adverse Effect, nor are there any orders, writs, injunctions, judgments or decrees outstanding of any court or government agency or instrumentality and binding upon the Issuer or any of its subsidiaries that have had or would reasonably be expected to have a Material Adverse Effect.
2.10 Compliance with Law; Permits. Neither the Issuer nor any of its subsidiaries is in violation of, or has received any notices of violations with respect to, any laws, statutes, ordinances, rules or regulations of any governmental body, court or government agency or instrumentality, except for violations which, individually or in the aggregate, have not had and would not reasonably be expected to have a Material Adverse Effect. The Issuer and its subsidiaries have all required licenses, permits, certificates and other authorizations (collectively, “Governmental Authorizations”) from such federal, state or local government or governmental agency, department or body that are currently necessary for the operation of the business of the Issuer and its subsidiaries as currently conducted, except where the failure to possess currently such Governmental Authorizations has not had and is not reasonably expected to have a Material Adverse Effect. Neither the Issuer nor any subsidiary has received any written (or, to the Issuer’s knowledge, oral) notice regarding any revocation or material modification of any such Governmental Authorization, which, individually or in the aggregate, if the subject of an unfavorable decision, ruling or finding, has or would reasonably be expected to result in a Material Adverse Effect.
2.11 Compliance with Nasdaq Continued Listing Requirements. The Issuer is in compliance with applicable Nasdaq continued listing requirements. There are no proceedings pending or threatened against the Issuer relating to the continued listing of the Issuer’s Common Stock on Nasdaq and the Issuer has not received any notice of, nor is there any reasonable basis for, the delisting of the Issuer’s Common Stock from Nasdaq.
2.12 Investment Company. The Issuer is not required to be registered as, and immediately following the Closing will not be required to register as, an “investment company” within the meaning of the Investment Company Act of 1940, as amended.
2.13 Brokers’ Fees. Other than fees payable to the Placement Agents pursuant to the terms of their agreement with the Issuer, dated July 31, 2025 (the “Engagement Letter”), there is no investment banker, broker, finder, financial advisor or other intermediary who has been retained by or is authorized to act on behalf of the Issuer who is entitled to any fee or commission from the Investor in connection with the Investor’s purchase of the Shares as contemplated by this Agreement. The Issuer has provided to the Investor a true, correct and complete copy of the Engagement Letter, which has not been amended or modified.
2.14 Ligand Private Placement. The shares of Common Stock to be purchased by Ligand Pharmaceuticals Incorporated in the Ligand Private Placement will be purchased at a price per share of Common Stock at least equal to the price at which the Common Stock is sold to the public in the Subsequent Offering, as set forth on the cover page of the prospectus filed in connection with the Subsequent Offering.
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Article III
REPRESENTATIONS AND WARRANTIES OF THE INVESTOR
The Investor represents and warrants to the Issuer and the Placement Agents that the statements contained in this Article III are true and correct as of the date of this Agreement and as of the Closing:
3.1 Organization and Good Standing. The Investor is duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization.
3.2 Authorization and Validity of Transaction Agreements. The Investor has all requisite power and authority to execute and deliver the Transaction Agreements, to perform its obligations hereunder and thereunder and to consummate the transactions contemplated hereby and thereby. The execution and delivery of the Transaction Agreements, the performance by the Investor of its obligations hereunder and thereunder and the consummation of the transactions contemplated hereby and thereby have been duly and validly authorized by all requisite corporate action of the Investor. Assuming this Agreement constitutes the legal and binding agreement of the Issuer, this Agreement constitutes a legal, valid and binding obligation of the Investor, enforceable against the Investor in accordance with its terms, except as such enforceability may be limited or otherwise affected by bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and/or similar laws relating to or affecting the rights of creditors generally or by general equity principles (regardless of whether such enforceability is considered in a proceeding in equity or at law).
3.3 Non-Contravention. The execution and delivery of the Transaction Agreements by the Investor, the performance by the Investor of its obligations hereunder and thereunder, and the consummation by the Investor of the transactions contemplated hereby and thereby do not, and will not as of the Closing, conflict with, contravene, result in a violation or breach of or default under (with or without the giving of notice or the lapse of time, or both), permit any party to terminate, amend or accelerate the provisions of, or result in the imposition of any Lien (or any obligation to create any Lien) upon any of the property or assets of the Investor under (i) any Contract to which the Investor is a party or by which any of its property or assets may be bound, except as would not, individually or in the aggregate, be reasonably expected to materially delay or hinder the ability of the Investor to perform its obligations under the Transaction Agreements or (ii) any provision of the organizational documents of the Investor.
3.4 Investment Purpose. The Shares to be acquired by the Investor pursuant to this Agreement are being acquired for investment for its own account and with no intention of distributing or reselling the Shares or any part thereof in any transaction that would be in violation of the securities laws of the United States or any state of the United States or any foreign jurisdiction. The Investor further agrees that it has not entered and prior to the Closing will not enter into any Contract with respect to the distribution, sale, transfer or delivery of the Shares.
3.5 Investment Experience; Access to Information. The Investor is sufficiently experienced in financial and business matters to be capable of evaluating the merits and risks involved in purchasing the Shares and to make an informed decision relating thereto and can bear the economic risk of its investment in the Shares. The Investor has carefully reviewed any disclosure documents (including the Transaction Agreements and the SEC Reports) used in connection with the sale of Shares pursuant to this Agreement. The Investor has had adequate opportunity to ask questions of, and receive answers from, the officers, employees, agents, accountants, and representatives of the Issuer concerning the business, operations, financial condition, assets, liabilities of the Issuer and all other matters relevant to its investment in the Shares. The Investor has not been organized solely for the purpose of acquiring the Shares.
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3.6 Independent Investment Decision. The Investor understands that nothing in this Agreement or any other materials presented by or on behalf of the Issuer to the Investor in connection with the purchase of the Shares constitutes legal, tax or investment advice. The Investor has consulted such legal, tax and investment advisors as it, in such Investor’s sole discretion, has deemed necessary or appropriate in connection with its purchase of the Shares.
3.7 Restricted Shares.
(a) The Investor understands and hereby acknowledges that the Shares are “restricted securities” within the meaning of Rule 144 promulgated under the Securities Act and have not been registered under the Securities Act or any state securities law and may not be offered or sold except pursuant to registration or pursuant to an exemption from the registration requirements of the Securities Act and any applicable states securities laws. The Investor 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.
(b) The Investor acknowledges and agrees that it has been advised to consult legal counsel prior to making any offer, resale, transfer, pledge or disposition of any of the Shares.
(c) The Investor acknowledges that no federal or state agency has passed upon or endorsed the merits of the offering of the Shares or made any findings or determination as to the fairness of this investment.
(d) The Investor understands and hereby acknowledges that the Shares, and any securities issued in respect of or in exchange for the Shares, will bear a legend in substantially the following form:
THE SHARES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, (“THE SECURITIES ACT”) OR APPLICABLE STATE LAWS, AND MAY NOT BE OFFERED, SOLD, ASSIGNED, PLEDGED, TRANSFERRED OR OTHERWISE DISPOSED OF IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR PURSUANT TO AN AVAILABLE EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT.
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3.8 Qualified Institutional Buyer; Accredited Investor. The Investor is a “qualified institutional buyer” (as defined in Rule 144A under the Securities Act) or an institutional “accredited investor” as that term is defined in Rule 501(a) under Regulation D promulgated pursuant to the Securities Act. The Investor further represents and warrants that (x) it is capable of evaluating the merits and risk of such investment and (y) that it has not been organized for the purpose of acquiring the Shares and is an “institutional account” as defined by FINRA Rule 4512(c). The Investor is aware that the Issuer is relying upon the representations, warranties and agreements contained in this Agreement for the purpose of determining whether this transaction meets the requirements of the exemption from the registration requirements of the Securities Act and any applicable state laws.
3.9 Non-Solicitation. The Investor acknowledges and agrees that the Investor is purchasing the Shares directly from the Issuer. Investor became aware of this offering of the Shares directly from the Issuer as a result of a pre-existing, substantive relationship with the Issuer, and/or its advisors (including, without limitation, attorneys, accountants, bankers, consultants and financial advisors), agents, control persons, representatives, Affiliates, directors, officers, managers, members, and/or employees, and/or the representatives of such persons. The Shares were offered to Investor solely by direct contact between Investor and the Issuer and/or its representatives. Investor did not become aware of this offering of the Shares, nor were the Shares offered to Investor, by any other means, and neither the Issuer and/or its representatives acted as investment advisor, broker or dealer to Investor. The Investor is not purchasing the Shares as a result of any general or public solicitation or general advertising, or publicly disseminated advertisement, article, notice or other communication regarding the Shares published in any newspaper, magazine or similar media or broadcast over television, radio or the internet or presented at any seminar or any other general solicitation or general advertisement, including any of the methods described in Section 502(c) of Regulation D under the Securities Act.
3.10 Certain Trading Activities. Other than consummating the transaction contemplated hereby, the Investor has not, nor has any Person acting on behalf of or pursuant to any understanding with the Investor, directly or indirectly executed any purchases or sales, including a “short sale,” as such term is defined Rule 200 of Regulation SHO under the Exchange Act, of the securities of the Issuer during the period commencing as of the time that the Investor was first contacted by the Issuer or any other Person regarding the transaction contemplated hereby and ending immediately prior to the date of this Agreement. The Investor has maintained the confidentiality of all disclosures made to it in connection with this transaction (including the existence and terms of this transaction), other than disclosures made to its advisors and agents who have a need to know such information.
3.11 Placement Agents. The Investor hereby acknowledges and agrees for the express benefit of the Placement Agents that (a) the Placement Agents have not made and will not make any representation or warranty, whether express or implied, of any kind or character, or provide any advice or recommendation in connection with the execution, delivery and performance of the Transaction Agreements, and (b) the Placement Agents will not have any responsibility with respect to any information, certificates or documentation delivered by or on behalf of the Issuer pursuant to this Agreement, including (i) any representations, warranties or agreements made by any person or entity under or in connection with the execution, delivery and performance of the Transaction Agreements, or the execution, legality, validity or enforceability (with respect to any person) thereof, (ii) the business, affairs, financial condition, operations, properties or prospects of, or any other matter concerning the Issuer, or (iii) any valuation, offering or marketing materials, or any omissions from such materials.
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3.12 No Liability of Placement Agents to the Investor. The Investor agrees that none of the Placement Agents, any of their Affiliates or any of their officers, directors or employees shall be liable to the Investor in connection with its purchase of the Shares.
Article IV
COVENANTS
4.1 Registration Rights. Subject to the occurrence of the Closing, each of the parties hereto covenants to enter into the Registration Rights Agreement with respect to the Shares.
4.2 Listing. The Issuer shall use commercially reasonable efforts to maintain the listing and trading of its Common Stock on Nasdaq and, in accordance therewith, will use reasonable best efforts to comply in all material respects with the Issuer’s reporting, filing and other obligations under the rules and regulations of Nasdaq.
4.3 Integration; Aggregation. The Issuer shall not, and shall use its commercially reasonable efforts to ensure that no Affiliate of the Issuer shall, sell, offer for sale or solicit offers to buy or otherwise negotiate in respect of any security (as defined in Section 2 of the Securities Act) that will be integrated with the offer or sale of the Shares in a manner that would require the registration under the Securities Act of the sale of the Shares to the Investor, or that will be aggregated with the offer or sale of the Shares for purposes of the rules and regulations of Nasdaq such that it would require stockholder approval prior to the closing of such other transaction unless stockholder approval is obtained before the closing of such subsequent transaction.
4.4 Removal of Legends.
(a) In connection with any sale, assignment, transfer or other disposition of the Shares by the Investor pursuant to Rule 144 or pursuant to any other exemption under the Securities Act such that the purchaser acquires freely tradable shares and upon compliance by the Investor with the requirements of this Agreement, if requested by the Investor by notice to the Issuer, the Issuer shall request the transfer agent of its Common Stock to remove any restrictive legends related to the book entry account holding such shares and make a new, unlegended entry for such book entry shares sold or disposed of without restrictive legends as soon as reasonably practicable following any such request therefor from the Investor, provided that the Issuer has timely received from the Investor customary representations and other documentation reasonably acceptable to the Issuer in connection therewith. The Issuer shall be responsible for the fees of its transfer agent and its legal counsel associated with such legend removal.
(b) Anytime following the six month anniversary of the issuance of the Shares and provided that the Investor is not an Affiliate of the Issuer at such time, the Issuer shall as soon as reasonably practicable following receipt of a duly completed and executed Legend Removal Certificate from the Investor substantially in the form attached hereto as Exhibit B, (A) deliver to the transfer agent instructions that the transfer agent shall make a new, unlegended entry for such book entry shares, and (B) cause its counsel to deliver to the transfer agent one or more opinions to the effect that the removal of such legends in such circumstances may be effected under the Securities Act if required by the transfer agent to effect the removal of the legend in accordance with the provisions of this Agreement.
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4.5 Fees and Commissions. The Issuer shall be solely responsible for the payment of any placement agent’s fees, financial advisory fees, or broker’s commissions (other than for persons engaged by the Investor) relating to or arising out of the transactions contemplated hereby.
4.6 Indemnification.
(a) The Issuer agrees to indemnify and hold harmless the Investor and its directors, officers, trustees, members, managers, employees and agents (collectively, the “Indemnified Persons”), from and against any and all losses, claims, damages, liabilities and expenses (including without limitation reasonable and documented attorney fees and disbursements and other documented out-of-pocket expenses reasonably incurred in connection with investigating, preparing or defending any action, claim or proceeding, pending or threatened and the costs of enforcement thereof) to which such Person may become subject as a result of any breach of representation, warranty, covenant or agreement made by or to be performed on the part of the Issuer under the Transaction Agreements, and will reimburse any such Person for all such amounts as they are incurred by such Person solely to the extent such amounts have been finally judicially determined not to have resulted from such Person’s fraud or willful misconduct.
(b) Any person entitled to indemnification hereunder shall (i) give prompt written notice to the indemnifying party of any claim with respect to which it seeks indemnification and (ii) permit such indemnifying party to assume the defense of such claim with counsel reasonably satisfactory to the indemnified party; provided that any person entitled to indemnification hereunder shall have the right to employ separate counsel and to participate in the defense of such claim, but the fees and expenses of such counsel shall be at the expense of such person unless (a) the indemnifying party has agreed in writing to pay such fees or expenses, (b) the indemnifying party shall have failed to assume the defense of such claim and employ counsel reasonably satisfactory to such person or (c) in the reasonable judgment of any such person, based upon written advice of its counsel, a conflict of interest exists between such person and the indemnifying party with respect to such claims (in which case, if the person notifies the indemnifying party in writing that such person elects to employ separate counsel at the expense of the indemnifying party, the indemnifying party shall not have the right to assume the defense of such claim on behalf of such person); and provided, further, that the failure of any indemnified party to give written notice as provided herein shall not relieve the indemnifying party of its obligations hereunder, except to the extent that such failure to give notice shall materially adversely affect the indemnifying party in the defense of any such claim or litigation. It is understood that the indemnifying party shall not, in connection with any proceeding in the same jurisdiction, be liable for fees or expenses of more than one separate firm of attorneys at any time for all such indemnified parties. No indemnifying party will, except with the consent of the indemnified party, which consent shall not be unreasonably withheld, conditioned or delayed, consent to entry of any judgment or enter into any settlement unless such judgment or settlement (i) imposes no liability or obligation on, (ii) includes as an unconditional term thereof the giving of a complete, explicit and unconditional release from the party bringing such indemnified claims of all liability of the indemnified party in respect of such claim or litigation in favor of, and (iii) does not include any admission of fault, culpability, wrongdoing, or wrongdoing or malfeasance by or on behalf of, the indemnified party. No indemnified party will, except with the consent of the indemnifying party, which consent shall not be unreasonably withheld, conditioned or delayed, consent to entry of any judgment or enter into any settlement.
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(c) As used herein, “Person” means an individual, partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or any other entity or organization.
4.7 Further Assurances. Each party hereto shall execute and deliver such instruments and take such other actions prior to or after the Closing as any other party may reasonably request in order to carry out the intent of this Agreement, including without limitation obtaining any required consents or approvals from third parties. The Investor acknowledges that the Issuer will rely on the acknowledgments, understandings, agreements, representations and warranties contained in this Agreement. Prior to the Closing, the Investor agrees to promptly notify the Issuer if any of the acknowledgments, understandings, agreements, representations and warranties set forth in Article III of this Agreement are no longer accurate.
Article V
CONDITIONS PRECEDENT TO THE OBLIGATIONS
5.1 Mutual Conditions. The obligations of the Issuer and the Investor to consummate the purchase and sale of the Shares contemplated hereby are subject to the following conditions: (i) the occurrence of the closing of the Subsequent Offering and the simultaneous closing of the Ligand Private Placement resulting in the receipt by the Issuer of gross proceeds of at least $25,000,000 in the aggregate, (ii) the absence of any order, decree, judgment or injunction of a court of competent jurisdiction or other governmental or regulatory authority precluding the consummation of the purchase and sale of the Shares contemplated hereby and (iii) there shall not have been any action taken or any statute, rule or regulation enacted, promulgated or deemed applicable to, the purchase and sale of the Shares contemplated hereby by any court, governmental agency or regulatory or administrative authority that makes consummation of such transactions illegal.
5.2 Conditions to the Obligations of the Investor. The obligations of the Investor under this Agreement to consummate the purchase and sale of the Shares contemplated hereby are subject to the fulfillment (or waiver by the Investor) of the following conditions precedent:
(a) Representation and Warranties. The representations and warranties of the Issuer contained herein shall be true and correct in all material respects, except for those representation and warranties qualified by materiality or Material Adverse Effect, which shall be true and correct in all respects, as of the date of this Agreement and as of the Closing, as though made on and as of such date.
(b) Performance. The Issuer shall have performed in all material respects the obligations and conditions herein required to be performed or observed by the Issuer on or prior to the Closing.
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(c) Consents. The Issuer shall have obtained any and all consents, permits, approvals, registrations and waivers necessary for the consummation of the purchase and sale of the Shares, all of which shall be in full force and effect.
(d) Adverse Changes. Since the date of this Agreement, no event or series of events shall have occurred that has had or would reasonably be expected to have a Material Adverse Effect.
(e) Opinion of Issuer Counsel. The Issuer shall have delivered to the Investor the opinion of Paul Hastings LLP, dated as of the Closing, in customary form and substance to be reasonably agreed upon with the Investor and addressing such legal matters as the Investor and the Issuer reasonably agree.
(f) Compliance Certificate. An authorized officer of the Issuer shall have delivered to the Investor at the Closing a certificate certifying that the conditions specified in Sections 5.2(a), (b), (c), (d) and (h) of this Agreement have been fulfilled.
(g) Secretary’s Certificate. The Secretary of the Issuer shall have delivered to the Investor at the Closing a certificate certifying (i) the Issuer’s certificate of incorporation; (ii) the Issuer’s bylaws; and (iii) resolutions of the Issuer’s Board of Directors (or an authorized committee thereof) approving this Agreement, the Registration Rights Agreement, the transactions contemplated by this Agreement and the issuance of the Shares.
(h) Listing Requirements. No stop order or suspension of trading shall have been imposed by Nasdaq, the SEC or any other governmental or regulatory body with respect to public trading in the Common Stock. The Common Stock shall be listed on Nasdaq and shall not have been suspended, as of the Closing, by the SEC or Nasdaq from trading thereon nor shall suspension by the SEC or Nasdaq have been threatened, as of the Closing, in writing by the SEC or Nasdaq; and the Issuer shall have filed with Nasdaq a Notification Form: Listing of Additional Shares for the listing of the Shares and Nasdaq shall have raised no objection to such notice and the transactions contemplated hereby.
5.3 Conditions to the Obligations of the Issuer. The obligations of the Issuer under this Agreement to consummate the purchase and sale of the Shares contemplated hereby are subject to the fulfillment (or waiver in writing by the Issuer) of the conditions that (i) all representations and warranties of the Investor shall be deemed to have been made again at and as of the Closing and shall then be true and accurate and (ii) the Investor shall have performed and complied in all material respects with all agreements required by this Agreement to be performed or complied with by it prior to or at the Closing.
Article VI
MISCELLANEOUS
6.1 Termination. This Agreement may be terminated by mutual written consent of the Issuer and the Investor. In addition, this Agreement shall terminate prior to the consummation of the transactions contemplated hereby, if the closings of the Subsequent Offering and the Ligand Private Placement resulting in the receipt by the Issuer of aggregate gross proceeds of at least $25,000,000 do not occur prior to August 15, 2025. In the event of any termination of this Agreement, this Agreement shall become void and have no effect, without any liability to any person in respect hereof on the part of any party hereto, except for any liability resulting from such party’s breach of this Agreement prior to such termination.
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6.2 Survival. Each of the representations and warranties contained in this Agreement shall survive indefinitely. Each of the covenants contained in this Agreement shall survive the Closing until performed in accordance with their terms.
6.3 Assignment; Successors and Assigns. This Agreement and the rights granted hereunder may not be assigned by either party without the prior written consent of the other party. This Agreement shall be binding upon and inure to the benefit of the parties hereto and their successors and permitted assigns as provided in this Agreement.
6.4 Third Party Beneficiaries. Nothing in this Agreement, express or implied, is intended to confer upon any person, other than the parties hereto or their respective successors and permitted assigns, any rights, remedies, obligations or liabilities under or by any reason of this Agreement, except as expressly provided in this Agreement.
6.5 Amendments. The provisions of this Agreement may not be amended or modified except by a writing signed by each of the parties.
6.6 Governing Law. THIS AGREEMENT AND THE RIGHTS AND OBLIGATIONS OF THE PARTIES UNDER THIS AGREEMENT SHALL BE GOVERNED BY, AND CONSTRUED AND INTERPRETED IN ACCORDANCE WITH, THE LAW OF THE STATE OF NEW YORK, WITHOUT REGARD TO PRINCIPLES OF CONFLICTS OF LAW. EACH OF THE PARTIES HERETO IRREVOCABLY AND UNCONDITIONALLY SUBMITS TO THE EXCLUSIVE JURISDICTION OF THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK OR, IF SUCH COURT WILL NOT ACCEPT JURISDICTION, THE SUPREME COURT OF THE STATE OF NEW YORK OR ANY COURT OF COMPETENT CIVIL JURISDICTION SITTING IN NEW YORK COUNTY, NEW YORK FOR THE PURPOSE OF ANY ACTION OR JUDGMENT RELATING TO OR ARISING OUT OF THIS AGREEMENT OR ANY OF THE TRANSACTIONS CONTEMPLATED HEREBY AND TO THE LAYING OF VENUE IN SUCH COURT. EACH OF THE PARTIES HEREBY WAIVES THE DEFENSE OF AN INCONVENIENT FORUM TO THE MAINTENANCE OF ANY SUCH ACTION OR PROCEEDING IN SAID COURTS.
6.7 Waiver of Trial By Jury. TO THE EXTENT PERMITTED BY APPLICABLE LAW, EACH PARTY HERETO IRREVOCABLY WAIVES ALL RIGHT OF TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM, ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR ANY MATTER ARISING HEREUNDER.
6.8 Waivers; Remedies. No failure or delay on the part of any party in exercising any right, privilege, power or remedy under this Agreement, and no course of dealing shall (a) impair such right, power or remedy or (b) operate as a waiver thereof. No waiver shall be asserted against any party unless signed in writing by such party. The single or partial exercise of any right, power or remedy provided by law or under this Agreement shall not preclude any other or further exercise of any other right, power or remedy. The rights, powers and remedies provided in this Agreement are cumulative and not exclusive of any rights, powers and remedies provided by law.
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6.9 Notices.
(a) All notices, requests, demands, waivers and other communications to be given by either party hereunder shall be in writing and shall be (i) mailed by first-class, registered or certified mail, postage prepaid, (ii) sent by hand delivery or reputable overnight delivery service or (iii) sent by electronic mail to the following address:
If to the Issuer:
Orchestra BioMed Holdings, Inc.
150 Union Square Drive
New Hope, Pennsylvania 18938
Attention: Chief Financial Officer
Email: [Omitted Pursuant to Item 601(a)(6)]
with a copy (which shall not constitute notice) to:
Paul Hastings LLP
200 Park Avenue
New York, New York 10166
Attention: Yariv Katz
Email: [Omitted Pursuant to Item 601(a)(6)]
If to the Investor:
c/o Medtronic, Inc.
Medtronic Operational Headquarters
710 Medtronic Parkway
Minneapolis, Minnesota 55432-5604
Attention: Chris Eso, VP Corporate Development
Peter Shimabukuro, BD Legal
Email: [Omitted Pursuant to Item 601(a)(6)]
[Omitted Pursuant to Item 601(a)(6)]
with a copy (which shall not constitute notice) to:
Fredrikson & Byron, P.A.
60 South Sixth Street, Suite 1500
Minneapolis, MN 55402
Attention: Christopher J. Melsha
Email: [Omitted Pursuant to Item 601(a)(6)]
or such other address as may be specified in writing to the other party hereto.
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(b) All such notices, requests, demands, waivers and other communications shall be deemed to have been given and received (i) if by personal delivery or electronic mail, on the day of such delivery, (ii) if by first-class, registered or certified mail, on the fifth business day after the mailing thereof or (iii) if by reputable overnight delivery service, on the day delivered.
6.10 Execution in Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be deemed an original, but all such counterparts shall together constitute but one and the same instrument. Electronic signatures complying with the New York Electronic Signatures and Records Act (N.Y. State Tech. §§ 301-309), as amended from time to time, or other applicable law will be deemed original signatures for purposes of this Agreement. Transmission by telecopy, electronic mail or other transmission method of an executed counterpart of this Agreement will constitute due and sufficient delivery of such counterpart.
6.11 Headings. The Article and Section headings contained herein are for the convenience of the parties only and shall not affect the construction or interpretation of this Agreement.
6.12 Severability. Each provision of this Agreement shall be considered severable and if for any reason any provision or provisions herein are determined to be invalid, unenforceable or illegal under any existing or future law, such invalidity, unenforceability or illegality shall not impair the operation of or affect those portions of this Agreement which are valid, enforceable and legal.
6.13 Entire Agreement. This Agreement, including the exhibits hereto, contains the entire understanding of the parties with respect to the subject matter hereof, and supersedes all prior agreements and understandings, both written and oral, among the parties with respect to the subject matter hereof.
[Signature page follows]
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IN WITNESS WHEREOF, the parties have executed and delivered this Agreement as of the date first written above.
| ISSUER: | |
|---|---|
| Orchestra BioMed Holdings, Inc. | |
| By: | /s/ David P. Hochman |
| Name: David P. Hochman | |
| Title: Chief Executive Officer | |
| INVESTOR: | |
| Covidien Group S.à.r.l. | |
| By: | /s/Harsimran Kaur Virdee |
| Name: Harsimran Kaur Virdee | |
| Title: General Manager |
Exhibit A
Form of REGISTRATION RIGHTS Agreement
Exhibit B
LEGEND REMOVAL CERTIFICATE
Exhibit 10.6
Execution Version
SECOND****AMENDMENT
TO
LOAN AND SECURITY AGREEMENT
This SecondAmendment to Loan and Security Agreement (this “Amendment”) is dated as of July 31, 2025 and is entered into by and among (a) (i) ORCHESTRA BIOMED HOLDINGS, INC., a Delaware corporation (“Company”), (ii) ORCHESTRA BIOMED, INC., a Delaware corporation (“BioMed”), (iii) CALIBER THERAPEUTICS, LLC, a Delaware limited liability company (“Caliber”), (iv) BACKBEAT MEDICAL, LLC, a Delaware limited liability company (“BackBeat”), (v) FREEHOLD SURGICAL, LLC, a Delaware limited liability company (“Freehold”), (vi) MOTUS GI, LLC, a Delaware limited liability company (“Motus US”), and (vii) MOTUS GI MEDICAL TECHNOLOGIES LTD., a company organized under the laws of the State of Israel (“Motus ISR”, and together with Company, Biomed, Caliber, BackBeat, Freehold and Motus US, individually or collectively, as the context may require, “Borrower”), (b) the several banks and other financial institutions or entities from time to time party to the Loan Agreement (as defined below) (individually or collectively, as the context may require, “Lender”) and (c) HERCULES CAPITAL, INC., a Maryland corporation, in its capacity as administrative agent and collateral agent for itself and the Lender (in such capacity, including any successors or assigns, “Agent”). Capitalized terms used herein without definition shall have the same meanings given them in the Loan Agreement.
Recitals
**A.**Borrower, Agent and Lender have entered into that certain Loan and Security Agreement dated as of November 6, 2024, among Borrower, Agent and Lender, as amended by that certain First Amendment to Loan and Security Agreement dated as of December 30, 2024 (as has been and as may be further amended, restated, amended and restated, supplemented or otherwise modified from time to time, the “LoanAgreement”), pursuant to which Lender has agreed to extend and make available to Borrower certain advances of money.
**B.**In accordance with Section 11.3 of the Loan Agreement, Borrower has requested that Agent and Lender agree to amend certain provisions of the Loan Agreement.
**C.**Agent and Lender have agreed to so amend the Loan Agreement upon the terms and conditions more fully set forth herein.
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.**Amendments.
1.1 Section 1.1(Definitions). Section 1.1 of the Loan Agreement is amended by (i) amending and restating clause (j) of the definition of Permitted Indebtedness in its entirety as follows and (ii) inserting the following new clauses (k) and (l) in such definition:
“ (j) extensions, refinancings and renewals of any items of Permitted Indebtedness (other than Indebtedness pursuant to clauses (k) and (l)), provided that the principal amount is not increased or the terms modified to impose materially more burdensome terms upon Borrower or the applicable Subsidiary, as the case may be, and subject to any limitations on the aggregate amount of such Indebtedness;
(k) Indebtedness of Company, BioMed, Caliber and BackBeat owing to Ligand pursuant to the Revenue Interest Purchase Agreement; and
(l) Indebtedness of Company, BioMed, Caliber and BackBeat owing to Medtronic pursuant to the Medtronic Loan Agreement.”
1.2 Section 1.1(Definitions). Section 1.1 of the Loan Agreement is amended by (i) re-lettering clause (q) of the definition of Permitted Liens as clause (s) and (ii) inserting the following new clauses (q) and (r) in such definition:
“ (q) Liens granted by Company, BioMed, Caliber and BackBeat in favor of Ligand securing Company’s obligations under the Revenue Interest Purchase Agreement so long as such Liens encumber only the Collateral (as such term is defined in the Revenue Interest Purchase Agreement as in effect on the Second Amendment Closing Date) and so long as such Liens are subject to the Ligand Subordination Agreement;
(r) Liens granted by Company, BioMed and BackBeat in favor of Medtronic securing such Borrowers’ obligations under the Medtronic Loan Agreement so long as such Liens encumber only the Collateral (as such terms are defined in the Medtronic Loan Agreement as in effect on the Second Amendment Closing Date) and so long as such Liens are subject to the Ligand Subordination Agreement (which Medtronic, Inc. shall have joined as a creditor party thereto) ; and”
1.3 Section 1.1(Definitions). Section 1.1 of the Loan Agreement is hereby amended by adding the following new clause (h) to the definition of “Permitted Transfers” as follows:
“ (h) transfers by Borrower or any Loan Party pursuant to the Revenue Interest Purchase Agreement.”
1.4 Section 1.1(Definitions). Section 1.1 of the Loan Agreement is amended by inserting the following new terms and their respective definitions to appear alphabetically in Section 1.1 thereof:
“ “All Source Cash Proceeds” means unrestricted (including, not subject to any redemption, clawback, escrow or similar encumbrance or restriction) net cash proceeds from one or more (i) bona fide equity financings, (ii) upfront net cash proceeds from new business development partnerships permitted under this Agreement (provided, however, that only net cash business development proceeds received in connection with the Virtue SAB Transaction in excess of the upfront payment of Twenty-Five Million Dollars ($25,000,000) will be included for purposes of this clause (ii)), (iii) transactions pursuant to the Revenue Interest Purchase Agreement and/or (iv) a Subordinated Indebtedness financing with Medtronic, Inc., the terms of which are acceptable to Agent.”
“ “Cash Coverage Percentage” means (a) prior to the occurrence of the Performance Milestone Date, 70%, provided, however, that (i) at any time that Qualified Cash is less than Thirty Five Million Dollars ($35,000,000) but equal to or greater than Twenty Five Million Dollars ($25,000,000), the Cash Coverage Percentage shall be 80% and (ii) at any time that Qualified Cash is less than Twenty Five Million Dollars ($25,000,000), the Cash Coverage Percentage shall be 100%, or (b) upon and after the occurrence of the Performance Milestone Date, 60%, provided, however, that (i) at any time that Qualified Cash is less than Thirty Five Million Dollars ($35,000,000) but equal to or greater than Twenty Five Million Dollars ($25,000,000), the Cash Coverage Percentage shall be 70% and (ii) at any time that Qualified Cash is less than Twenty Five Million Dollars ($25,000,000), the Cash Coverage Percentage shall be 85%.”
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“ “Financing Milestone III” means satisfaction of each of the following events, subject to reasonable verification by Agent (including supporting documentation reasonably requested by Agent): (a) no Default or Event of Default shall have occurred and be continuing; and (b) Company has raised at least an amount equal to Ninety Million Dollars ($90,000,000) in All Source Cash Proceeds after July 18, 2025 and prior to June 30, 2026.”
“ “Financing Milestone III Date” means the date on which Borrower achieves Financing Milestone III.”
“ “Financing Milestone IV” means satisfaction of each of the following events, subject to reasonable verification by Agent (including supporting documentation reasonably requested by Agent): (a) no Default or Event of Default shall have occurred and be continuing; and (b) Company has raised at least an amount equal to One Hundred Ten Million Dollars ($110,000,000) in All Source Cash Proceeds after July 18, 2025 and prior to June 30, 2026.”
“ “Financing Milestone IV Date” means the date on which Borrower achieves Financing Milestone IV.”
“ “Ligand” means Ligand Pharmaceuticals, Inc., a Delaware corporation.”
“ “Ligand Subordination Agreement” means that certain Subordination Agreement dated as of the Second Amendment Closing Date among Ligand, Company, BioMed, Caliber, BackBeat and Agent, as the same may from time to time be amended, restated, modified or otherwise supplemented.”
“ “Medtronic Loan Agreement” means that certain Loan Agreement among Medtronic, Inc., Company, BioMed, Caliber and BackBeat to be entered into after the Second Amendment Closing Date, as the same may from time to time be amended, restated, modified or otherwise supplemented.”
“ “Release Letter” means that certain letter agreement dated as of the Second Amendment Closing Date by and among Agent, Ligand and Borrower with respect to the RPA Collateral (as defined therein).”
“ “Required Lenders” means at any time, the holders of more than fifty percent (50%) of the sum of the aggregate unpaid principal amount of the Term Loans then outstanding.”
“ “Revenue Interest Purchase Agreement” means the Revenue Participation Right Purchase and Sale Agreement dated as of July 31, 2025 between Ligand, Company, BioMed, Caliber and BackBeat, as the same may from time to time be amended, restated, modified or otherwise supplemented.”
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“ “RPA Collateral” has the meaning given to such term in the Release Letter.”
“ “Second Amendment Closing Date” means July 31, 2025.”
1.5 Section 1.1(Definitions). Section 1.1 of the Loan Agreement is hereby amended by amending and restating each of the definitions set forth below in their entirety as follows:
“ “Amortization Date” means July 1, 2027; provided however, if (a) the First Interest Only Extension Condition is satisfied, then October 1, 2027 and (b) the Second Interest Only Extension Condition is satisfied, then January 1, 2028.”
“ “Excluded Accounts” means (a) any of the following Deposit Accounts which are designated as such in writing to Agent as of the Closing Date or, with respect to any Deposit Account opened after the Closing Date, in the next Compliance Certificate delivered after such Deposit Account is opened: (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 holding an aggregate amount across all such accounts of not more than amounts needed for the then-next two (2) payroll cycles, (ii) any Deposit Account which is a zero-balance disbursement account, (iii) any Deposit Account which is solely used for disbursements and payments of withheld income taxes, payroll taxes and/or federal, state or local employee taxes, (iv) any Deposit Account which is solely used as a trust account, escrow account, or other fiduciary account, (v) any Deposit Account maintained in Israel by any Subsidiary organized or operating in Israel, subject to the limitations set forth in Section 7.12(b), (vi) any Deposit Accounts maintained with Silicon Valley Bank that are set forth in the Perfection Certificate on the Closing Date (the “Existing SVB Accounts”), so long as the balance of all such Excluded Accounts under this clause (vi) does not exceed $150,000 in the aggregate at any time and (vii) any Deposit Account solely used to hold cash and Cash Equivalents subject to Permitted Liens under clause (n) of the definition thereof, and (b) the Lockbox Account (as defined in the Revenue Interest Purchase Agreement) so long as (x) prior to the full approval by the FDA of either BackBeat CNT or Virtue SAB, no amounts are held in such account and (y) after approval by the FDA of either BackBeat CNT or Virtue SAB, the aggregate amount held in such account does not exceed the amount required to be held in such account at any time pursuant to Section 6.3(c) of the Revenue Interest Purchase Agreement (as in effect on the Second Amendment Closing Date).”
“ “First Interest Only Extension Condition” means that the Financing Milestone III Date has occurred on or prior to June 30, 2026.”
“ “Loan Documents” means this Agreement, the promissory notes (if any), the ACH Authorization, the Account Control Agreements, any Joinder Agreement, any Guaranty, any Warrant, the Pledge Agreement, the Intellectual Property Security Agreement, the Ligand Subordination Agreement and any other documents executed in connection with the Secured Obligations or the transactions contemplated hereby, as the same may from time to time be amended, modified, supplemented or restated.”
“ “Second Interest Only Extension Condition” means that each of (a) the Financing Milestone IV Date has occurred on or prior to June 30, 2026, and (b) the Performance Milestone Date has occurred on or prior to September 30, 2027.”
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“ “Term Commitment” means as to any Lender, the obligation of such Lender, if any, to make a Term Loan Advance to Borrower in a principal amount not to exceed the amount set forth under the heading “Tranche 1 Commitment” or “Tranche 3 Commitment” opposite such Lender’s name on Schedule 1.1.”
“ “Term Loan Advance” means each Tranche 1 Advance, Tranche 3 Advance and any other funds advanced under Section 2.1(a).”
“ “Tranche” means the Tranche 1 Advance and/or the Tranche 3 Advance, as applicable.”
1.6 Section 1.1(Definitions). Section 1.1 of the Loan Agreement is hereby amended by deleting each of the following definitions in their entirety where they appear in such section: “Tranche 2 Facility Charge”, “Tranche 2-A Commitment” and “Tranche 2-B Commitment”.
1.7 Section 2.1(Term Loan Advances). Section 2.1(a) of the Loan Agreement is hereby amended by amending and restating clause (ii), clause (iii) and clause (iv) thereof in its entirety as follows:
“ (ii) [reserved]”
(iii) [reserved]”
(iv) Tranche3. Subject to the terms and conditions of this Agreement, Borrower may request and Lenders shall severally (and not jointly) make, on or prior to the Amortization Date but only following and conditioned on the approval by the Lender’s investment committee in its sole and unfettered discretion, in each case, one or more additional Term Loan Advances in minimum increments of Five Million Dollars ($5,000,000) (or if less, the remaining amount of Term Loan Advances available to be drawn pursuant to this Section 2.1(a)(iv)) in an aggregate principal amount up to Thirty Five Million Dollars ($35,000,000) (such Term Loan Advances, the “Tranche 3 Advances”).”
1.8 Section 2.1(Term Loan Advances). The second sentence of Section 2.1(d) of the Loan Agreement is hereby amended and restated in its entirety as follows:
“Borrower shall repay the aggregate principal balance of the Term Loan Advances that is outstanding on the day immediately subsequent to the Amortization Date, in equal monthly installments of principal and interest (mortgage style) beginning on the Amortization Date and continuing on the first calendar day of each month thereafter until the Secured Obligations (other than inchoate indemnity obligations which, by their terms, survive termination of this Agreement) are repaid.”
1.9 Section 3(Security Interest). Section 3.2 of the Loan Agreement is hereby amended and restated in its entirety as follows:
“ 3.2 Notwithstanding the broad grant of the security interest set forth in Section 3.1, above, the Collateral shall not include (a) any “intent to use” trademarks at all times prior to the first use thereof, whether by the actual use thereof in commerce, the recording of a statement of use with the United States Patent and Trademark Office or otherwise, provided, that upon submission and acceptance by the United States Patent and Trademark Office of an amendment to allege use of an intent-to-use trademark application pursuant to 15 U.S.C. Section 1060(a) (or any successor provision) such intent-to-use application shall constitute Collateral, (b) nonassignable licenses or contracts, which by their terms require the consent of the licensor thereof or another party (but only to the extent such prohibition on transfer is enforceable under applicable law, including, without limitation, Sections 9406, 9407 and 9408 of the UCC), (c) any Excluded Account and (d) the RPA Collateral.”
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1.10 Section 4.2(All Advances). Section 4.2(d) of the Loan Agreement is hereby amended and restated in its entirety as follows:
“ (d) [reserved]”
1.11 Section 7.5(Collateral). The first sentence of Section 7.5 of the Loan Agreement is hereby amended and restated in its entirety as follows:
“Borrower shall at all times (a) keep the Collateral and all other property and assets used in Borrower’s business or in which Borrower now or hereafter holds any interest free and clear from any legal process or Liens whatsoever (except for Permitted Liens), and (b) shall give Agent prompt written notice of any legal process affecting the Collateral, such other property and assets, or any Liens thereon, provided however, that the Collateral and such other property or assets may be subject to Permitted Liens except that there shall be no Liens whatsoever on Intellectual Property except for the Permitted Liens set forth under clauses (q) and (r) of the definition of Permitted Liens.”
1.12 Section 7.20(Financial Covenants). Section 7.20(a)(i) of the Loan Agreement is hereby amended and restated in its entirety as follows:
“ (i) Beginning on the Testing Effective Date and (subject to the proviso to the definition of “Testing Effective Date”) at all times thereafter, Borrower shall maintain Qualified Cash in an amount greater than or equal to (x) the outstanding principal amount of the Term Loan Advances, multiplied by (y) the applicable Cash Coverage Percentage.”
1.13 Schedule1.1(a) (Commitments). Schedule 1.1(a) of the Loan Agreement is hereby deleted and replaced by the Schedule 1.1(a) appearing as Exhibit A to this Amendment.
**2.**Borrower’sRepresentations And Warranties. Borrower represents and warrants that:
2.1Immediately upon giving effect to this Amendment (i) the representations and warranties contained in the Loan Documents are true and correct in all material respects 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, provided that the representation in Section 5.15 of the Loan Agreement shall also include confirmation that Motus ISR is not deemed insolvent under the Israeli Insolvency Law; and (ii) no default or Event of Default has occurred and is continuing with respect to which Borrower has not been notified in writing by Agent or Lender.
2.2Borrower has the corporate or other applicable company power and authority to execute and deliver this Amendment and to perform its obligations under the Loan Agreement, as amended by this Amendment. Motus ISR has not been declared nor has it been warned that it may be declared a “breaching company” (“hevrah meferah”) by the Israeli Companies Registrar, as such term is defined in the Israeli Companies Law.
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2.3The 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 by all necessary corporate or other applicable company action on the part of Borrower.
2.4This Amendment has been duly executed and delivered by Borrower and is the binding obligation of Borrower, enforceable against it in accordance with its terms, except as such enforceability may be limited by bankruptcy, insolvency, reorganization, receivership, moratorium or other laws affecting creditors’ rights generally and by general principles of equity.
2.5As of the date hereof, Borrower has no defenses against the obligations to pay any amounts under the Secured Obligations. Borrower acknowledges that each of Agent and Lender has, as of the date hereof, acted in good faith and has conducted in a commercially reasonable manner its relationships with Borrower in connection with this Amendment and in connection with the Loan Documents.
Borrower understands and acknowledges that each of Agent and Lender is entering into this Amendment in reliance upon, and in partial consideration for, the above representations and warranties, and agrees that such reliance is reasonable and appropriate.
**3.**Limitation. The amendments set forth in this Amendment shall be limited precisely as written and shall not be deemed (a) to be a waiver or modification of any other term or condition of the Loan Agreement or of any other instrument or agreement referred to therein or to prejudice any right or remedy which Agent and/or Lender may now have or may have in the future under or in connection with the Loan Agreement (as amended hereby) or any instrument or agreement referred to therein; or (b) to be a consent to any future amendment or modification or waiver to any instrument or agreement the execution and delivery of which is consented to hereby. Except as expressly amended hereby, the Loan Agreement shall continue in full force and effect.
**4.**Effectiveness. This Amendment shall become effective upon the satisfaction of all the following conditions precedent (such date of satisfaction of all such conditions precedent, the “Second Amendment Closing Date”):
4.1 Amendment. Borrower, Agent and Lender shall have duly executed and delivered this Amendment to Agent.
4.2 SubordinationAgreement. Borrower shall have delivered a duly executed copy of a subordination agreement between Agent and Ligand in form and substance satisfactory to Agent in its sole discretion.
4.3 WarrantAmendments. Borrower shall have delivered a duly executed copy of an Amendment No. 1 to Warrant Agreement between each Lender and Company, each in form and substance satisfactory to the applicable Lender.
4.4 Pre-ClosingProceeds. Borrower shall have delivered to Agent evidence satisfactory to Agent that Borrower has received unrestricted and unencumbered All Source Cash Proceeds of at least Seventy Million Dollars ($70,000,000) on or after July 18, 2025; provided that, for purposes of this condition precedent only, All Source Cash Proceeds shall be deemed to include all amounts committed to be funded to Company with no performance milestones on or prior to June 30, 2026 pursuant to transactions of the type described in the definition of All Source Cash Proceeds.
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4.5 RevenueInterest Purchase Agreement. Agent shall have received satisfactory evidence that the “Closing” under the Revenue Interest Purchase Agreement shall have occurred. Agent shall have received fully executed copies of the Revenue Interest Purchase Agreement and all transaction documents related thereto, which shall be in form and substance satisfactory to Agent.
4.6 Paymentof Lender Expenses. Borrower shall have paid all reasonable Lender expenses (including all reasonable attorneys' fees and reasonable expenses) incurred through the date of this Amendment for the documentation and negotiation of this Amendment, in each case, to the extent invoiced on or prior to the Second Amendment Closing Date.
**5.**Release. In consideration of the agreements of Agent and each Lender contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Borrower, on behalf of itself and its successors, assigns, and other legal representatives, hereby to the extent possible under applicable law fully, absolutely, unconditionally and irrevocably releases, remises and forever discharges Agent and each Lender, and its successors and assigns, and its present and former shareholders, affiliates, subsidiaries, divisions, predecessors, directors, officers, attorneys, employees, agents and other representatives (Agent, Lender and all such other persons being hereinafter referred to collectively as the “Releasees” and individually as a “Releasee”), of and from all demands, actions, causes of action, suits, covenants, contracts, controversies, agreements, promises, sums of money, accounts, bills, reckonings, damages and any and all other claims, counterclaims, defenses, rights of set-off, demands and liabilities whatsoever of every name and nature, known or unknown, suspected or unsuspected, both at law and in equity, which Borrower, or any of its successors, assigns, or other legal representatives may now or hereafter own, hold, have or claim to have against the Releasees or any of them for, upon, or by reason of any circumstance, action, cause or thing whatsoever which arises at any time prior to the execution of this Amendment, for or on account of, or in relation to, or in any way in connection with the Loan Agreement, or any of the other Loan Documents or transactions thereunder or related thereto. Borrower understands, acknowledges and agrees that the release set forth above may be pleaded as a full and complete defense and may be used as a basis for an injunction against any action, suit or other proceeding which may be instituted, prosecuted or attempted in breach of the provisions of such release. Borrower agrees that no fact, event, circumstance, evidence or transaction existing prior to the execution of this Amendment which could now be asserted or which may hereafter be discovered shall affect in any manner the final, absolute and unconditional nature of the release set forth above. Borrower waives the provisions of California Civil Code section 1542, which states:
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.
**6.**Counterparts. This Amendment may be signed in any number of counterparts, and by different parties hereto in separate counterparts, with the same effect as if the signatures to each such counterpart were upon a single instrument. All counterparts shall be deemed an original of this Amendment. This Amendment may be executed by facsimile, portable document format (.pdf) or similar technology signature, and such signature shall constitute an original for all purposes.
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**7.**Incorporation ByReference. The provisions of Section 11 of the Loan Agreement shall be deemed incorporated herein by reference, mutatis mutandis.
**8.**Reaffirmation. By executing and delivering a counterpart hereof, (i) Borrower hereby agrees that all Advances incurred by Borrower shall be secured by the Collateral pursuant to the applicable Loan Documents in accordance with the terms and provisions thereof and (ii) Borrower hereby (A) agrees that, notwithstanding the effectiveness of this Amendment, after giving effect to this Amendment, the Loan Documents continue to be in full force and effect, (B) agrees that all of the Liens and security interests created and arising under the Loan Documents remain in full force and effect on a continuous basis, and the perfected status and priority of each such Lien and security interest continues in full force and effect on a continuous basis, unimpaired, uninterrupted and undischarged, as collateral security for its obligations, liabilities and indebtedness under the Loan Agreement to the extent provided in, and subject to the limitations and qualifications set forth in, such Loan Documents (as amended by this Amendment) and (C) affirms and confirms all of its obligations, liabilities and indebtedness under the Loan Agreement and each other Loan Document, in each case after giving effect to this Amendment, including the pledge of and/or grant of a security interest in its assets as Collateral pursuant to the Loan Documents to secure such Secured Obligations, all as provided in the Loan Documents, and acknowledges and agrees that such obligations, liabilities, guarantee, pledge and grant continue in full force and effect in respect of, and to secure, such Secured Obligations under the Loan Agreement and the other Loan Documents, in each case, to the extent provided in, and subject to the limitations and qualifications set forth in, such Loan Documents (as amended by this Amendment).
[Signature Page Follows]
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In WitnessWhereof, the parties have duly authorized and caused this Amendment to be executed as of the date first written above.
| BORROWERS: | |
|---|---|
| orchestra<br> biomed holdings, INC. | |
| Signature: | /s/ David P. Hochman |
| Print<br> Name: | David P. Hochman |
| Title: | Chief Executive Officer |
| orchestra<br> biomed, INC. | |
| Signature: | /s/ David P. Hochman |
| Print<br> Name: | David P. Hochman |
| Title: | Chief Executive Officer |
| CALIBER<br> THERAPEUTICS, LLC | |
| Signature: | /s/ David P. Hochman |
| Print<br> Name: | David P. Hochman |
| Title: | Chief Executive Officer |
| BACKBEAT<br> MEDICAL, LLC | |
| Signature: | /s/ David P. Hochman |
| Print<br> Name: | David P. Hochman |
| Title: | Chief Executive Officer |
[Signature Page – Second Amendment to Loan and Security Agreement]
| FREEHOLD<br> SURGICAL, LLC | |
|---|---|
| Signature: | /s/ David P. Hochman |
| Print<br> Name: | David P. Hochman |
| Title: | Chief Executive Officer |
| MOTUS<br> GI, LLC | |
| Signature: | /s/ David P. Hochman |
| Print<br> Name: | David P. Hochman |
| Title: | Chief Executive Officer |
| MOTUS<br> GI MEDICAL TECHNOLOGIES LTD. | |
| Signature: | /s/ David P. Hochman |
| Print<br> Name: | David P. Hochman |
| Title: | Chief Executive Officer |
[Signature Page – Second Amendment to Loan and Security Agreement]
Accepted in San Mateo, California:
| AGENT: | |
|---|---|
| HERCULES CAPITAL, INC. | |
| Signature: | /s/ Jennifer Choe |
| Print Name: | Jennifer Choe |
| Title: | Deputy General Counsel, <br><br> Portfolio Transactions |
| LENDERS: | |
| HERCULES CAPITAL, INC. | |
| Signature: | /s/ Jennifer Choe |
| Print Name: | Jennifer Choe |
| Title: | Deputy General Counsel, <br><br> Portfolio Transactions |
| HERCULES CAPITAL IV, L.P. | |
| By: Hercules Technology SBIC Management,<br> LLC, its General Partner | |
| By: Hercules Capital, Inc., its Manager | |
| Signature: | /s/ Jennifer Choe |
| Print Name: | Jennifer Choe |
| Title: | Deputy General Counsel, <br><br> Portfolio Transactions |
| HERCULES SBIC V, L.P. | |
| By: Hercules Technology SBIC Management,<br> LLC, its General Partner | |
| By: Hercules Capital, Inc., its Manager | |
| Signature: | /s/ Jennifer Choe |
| Print Name: | Jennifer Choe |
| Title: | Deputy General Counsel, <br><br> Portfolio Transactions |
[Signature Page – Second Amendment to Loan and Security Agreement]
Exhibit A
Schedule 1.1(a)
COMMITMENTS
Exhibit 10.7
REGISTRATION RIGHTS AGREEMENT
THIS REGISTRATION RIGHTS AGREEMENT (this “Agreement”), dated as of [●], 2025, is entered into by and among Orchestra BioMed Holdings, Inc., a Delaware corporation (the “Company”), and the investors listed on the signature pages hereto (each, an “Investor” and collectively, the “Investors”). Certain capitalized terms used herein and not otherwise defined have the meaning given to them in Section 9(a) hereof.
W I T N E S S E T H:
WHEREAS, in connection with:
| · | the Revenue Participation Right Purchase and Sale Agreement, dated as of<br>July 31, 2025 (the “Purchase and Sale Agreement”), by and among the Company and Ligand Pharmaceuticals<br>Incorporated, a Delaware corporation (“Ligand”), the Company has agreed, upon the terms and subject to the conditions<br>of the Purchase and Sale Agreement, to issue and deliver to Ligand a warrants (the “Warrants”) to purchase shares of<br>the Company’s common stock, par value $0.0001 per share (the “Common Stock” and such shares of Common Stock,<br>the “Warrant Shares”); |
|---|---|
| · | the Stock Purchase Agreement, dated as of July 31, 2025, by and<br>between the Company and Ligand (the “Ligand Stock Purchase Agreement”), pursuant to which, Ligand agreed to purchase<br>from the Company and the Company agreed to sell to Ligand, $5,000,000 of Common Stock (the “Ligand PIPE Shares”), subject<br>to the terms and conditions of the Ligand Stock Purchase Agreement; and |
| --- | --- |
| · | the Stock Purchase Agreement, dated as of July 31, 2025, by and<br>between the Company and Covidien Group S.à.r.l. (“Medtronic”), a private limited liability company (société<br> à responsabilité limitée), incorporated under the laws of the Grand Duchy of Luxembourg (the “MedtronicStock Purchase Agreement” and, together with the Ligand Stock Purchase Agreement, the “Stock Purchase Agreements”),<br>pursuant to which, Medtronic agreed to purchase from the Company and the Company agreed to sell to Medtronic, up to $12,000,000 of Common<br>Stock (the “Medtronic PIPE Shares” and, together with the Ligand PIPE Shares, the “PIPE Shares”),<br>subject to the terms and conditions of the Medtronic Stock Purchase Agreement. |
| --- | --- |
WHEREAS, the Investors have requested, and the Company has agreed to provide, certain rights with respect to the registration of the resale of the Warrant Shares and the PIPE Shares, subject to the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the mutual covenants and agreements herein contained, the parties hereto hereby agree as follows:
Section 1. ShelfRegistration.
(a) On or prior to the Filing Deadline, the Company shall prepare and file with the SEC a registration statement under the Securities Act covering the resale of all of the Registrable Securities for an offering to be made on a continuous basis pursuant to Rule 415 on Form S-3 (or any successor short form registration statement available for such resale that permits incorporation by reference at least to the same extent as such form) (“Form S-3”) or, if Form S-3 is not then available to the Company, on such form of registration statement as is then available to effect a registration for resale of the Registrable Securities (together with the Form S-3, the “Registration Statement”). The Registration Statement shall contain (except if otherwise required pursuant to written comments received from the SEC upon a review of such Registration Statement) a “Plan of Distribution” in substantially the form attached hereto as Exhibit A and a “Selling Stockholder” section in substantially the form attached hereto as Exhibit B; provided, however, that no Investor shall be named as an “underwriter” in the Registration Statement without such Investor’s prior written consent, except that an Investor may be named as a “statutory underwriter” if such Investor is, or is affiliated with, a broker-dealer and states such fact in its Selling Stockholder Questionnaire. The Registration Statement also shall cover, to the extent allowable under the Securities Act and the rules promulgated thereunder (including Rule 416), such indeterminate number of additional shares of Common Stock resulting from stock splits, stock dividends or similar transactions with respect to the Registrable Securities registered under such Registration Statement. Such Registration Statement shall not include any shares of Common Stock or other securities for the account of any other holder of securities of the Company without the prior written consent of the Investors.
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(b) The Company shall use its commercially reasonable efforts to cause the Registration Statement to be declared effective after its filing at the earliest possible date, but no later than the earlier of (i) the one hundred and eightieth (180^th^) calendar day following the issuance of the PIPE Shares, if the SEC notifies the Company that it will “review” the Registration Statement and (ii) the fifth (5^th^) Business Day after the date the Company is notified (orally or in writing, whichever is earlier) by the SEC that the Registration Statement will not be “reviewed” or will be subject to no further review. Subject to Section 8, the Company shall use its commercially reasonable efforts to keep the Registration Statement effective under the Securities Act until the date as of which there are no longer any Registrable Securities registered thereunder (the “Effectiveness Period”). The Company shall promptly, and in any event within 24 hours, notify the Investors of the effectiveness of each Registration Statement and shall promptly, and in no event later than the second Business Day after the Company receives notice of the effectiveness of each Registration Statement, file a final prospectus with the SEC, as required by Rule 424(b).
(c) Subject to Section 8, in the event that Form S-3 is not available for the registration of the resale of Registrable Securities hereunder, the Company shall (i) register the resale of the Registrable Securities on another appropriate form and (ii) undertake to register the Registrable Securities on Form S-3 promptly after such form is available, provided, that the Company shall maintain the effectiveness of the registration statement then in effect until such time as a registration statement on Form S-3 covering the Registrable Securities has been declared effective by the SEC.
(d) In the event that the Registration Statement ceases to be effective for any reason at any time (other than because all Registrable Securities registered thereunder shall have been sold pursuant thereto or shall have otherwise ceased to be Registrable Securities), the Company shall, subject to Section 8, use its reasonable best efforts to obtain the prompt withdrawal of any order suspending the effectiveness thereof or file a subsequent Registration Statement covering all of the securities that, as of the date of such filing or designation, are Registrable Securities.
(e) If a Registration Statement is then effective, subject to Section 3, an Investor may sell Registrable Securities available for sale by it pursuant to such Registration Statement, and the Company shall pay all Registration Expenses in connection therewith (other than discounts and commissions payable in connection with the sale of such Investor’s securities thereunder).
(f) Notwithstanding anything to the contrary contained herein, Ligand’s sole recourse against the Company for failing to have the Registration Statement available for the resale of the Warrant Shares is to exercise the Warrants by Cashless Exercise (as such term is defined in the Warrants), and the Company shall have no liability to Ligand for failing to have the Registration Statement available for the resale of the Warrant Shares.
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Section 2. RegistrationProcedures; Commercially Reasonable Efforts. In connection with any registration contemplated hereunder, the Company shall:
(a) At least ten (10) Business Days before filing the Registration Statement pursuant to Section 1 hereof, the Company will furnish to the Investors notice of the proposed filing date of such Registration Statement (the “Proposed Filing Date”) and a copy of a draft of the Registration Statement. Each Investor shall review and approve the Selling Stockholder and Plan of Distribution sections of the Registration Statement, which approval shall not be unreasonably withheld or delayed. Any objections to the draft Registration Statement must be lodged within two (2) Business Days of such Investor’s receipt thereof. The Company shall (a) use commercially reasonable efforts to address the comments of each Investor or its counsel reasonably proposed by the Investor, and (b) not file the Registration Statement containing information regarding an Investor to which such Investor reasonably objects, unless management of the Company, after consulting with Company counsel, determines, in its sole discretion, such information is required to comply with any applicable law or regulation. Other than any Investor that indicates to the Company in writing that it does not wish to be named as a “selling stockholder” in such Registration Statement, each Investor agrees to furnish to the Company a completed questionnaire in the form attached hereto as Exhibit C (a “Selling Stockholder Questionnaire”) on a date that is not less than five (5) Business Days prior to the Proposed Filing Date;
(b) Notify immediately the Investors of any stop order threatened or issued by the SEC and take all actions reasonably required to prevent the entry of a stop order or if entered to have it rescinded or otherwise removed;
(c) Use its commercially reasonable best efforts to prepare and file with the SEC such amendments and supplements to the Registration Statement necessary to keep the Registration Statement effective under the Securities Act for the Effectiveness Period and comply with the provisions of the Securities Act with respect to the disposition of all securities covered by the Registration Statement during each period in accordance with the Investors’ intended methods of disposition as set forth in the Registration Statement; provided, that least three (3) Business Days before filing any such amendments or supplements to the Registration Statement, the Company will furnish to the Investors notice of the proposed filing date of such amendment or supplement and a copy of a draft of such amendment or supplement to the Registration Statement for review by the Investors. The Company shall (a) use commercially reasonable efforts to address the comments of the Investors or their counsel reasonably proposed by the Investors, and (b) not file any amendment or supplement to the Registration Statement containing information regarding an Investor to which such Investor reasonably objects, unless management of the Company, after consulting with Company counsel, determines, in its sole discretion, such information is required to comply with any applicable law or regulation;
(d) Furnish to the Investors a sufficient number of copies of the Registration Statement and such other documents as each Investor may reasonably request to facilitate the disposition of its Registrable Securities; provided, that the Company shall have no obligation to provide any document pursuant to this clause that is available on the EDGAR system;
(e) Use its commercially reasonable efforts to register or qualify the Registrable Securities subject to registration under securities or blue sky laws of jurisdictions in the United States of America as any Investor requests and will do any and all other acts and things that may be necessary or advisable to enable such Investor to consummate the disposition of its Registrable Securities; provided that the Company shall not be required to qualify to do business or to file a general consent to service of process in any such jurisdictions, unless the Company is already subject to service in such jurisdiction and except as may be required by the Securities Act;
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(f) Use its commercially reasonable efforts to cause the Registrable Securities covered by the Registration Statement to be registered with or approved by those governmental agencies or authorities necessary to enable the Investors to consummate the disposition of its Registrable Securities;
(g) Promptly (but in no event later than 24 hours) notify the Investors, at any time when a prospectus is required to be delivered under the Securities Act, of any event as a result of which the prospectus or any document incorporated therein by reference contains an untrue statement of a material fact or omits to state any material fact necessary to make the statements therein not misleading, and will promptly prepare a supplement or amendment to the prospectus or any such document incorporated therein by reference so that thereafter the prospectus will not contain an untrue statement of a material fact or omit to state any material fact necessary to make the statements therein not misleading;
(h) Use its commercially reasonable efforts to cause all Registrable Securities to be listed on the same securities exchange, with the same CUSIP, and with the same transfer agent, as similar securities issued by the Company are then listed; and
Section 3. SuspensionPeriod.
(a) The Company may suspend the use of a prospectus that is part of a Registration Statement for up to an aggregate sixty (60) days on no more than two (2) occasions in any given twelve (12)-month period, and therefore suspend sales of Registrable Securities available for sale pursuant to such Registration Statement (such period, the “Suspension Period”) by providing written notice to the Investors if the Company’s board of directors determines in its reasonable good faith judgment that such suspension is in the best interests of the Company.
(b) In the case of an event that causes the Company to suspend the use of a Registration Statement as set forth in Section 3(a) above (a “Suspension Event”), the Company shall promptly (but in no event later than 24 hours) give a written notice to the Investors (a “Suspension Notice”) to suspend sales of the Registrable Securities (but shall not contain any material non-public information concerning the Company) and that such suspension shall continue only for so long as the Suspension Event is continuing. An Investor shall not effect any sales of the Registrable Securities pursuant to such Registration Statement (or such filings) at any time after it has received a Suspension Notice from the Company and prior to receipt of an End of Suspension Notice (as defined below). Each Investor agrees that such Investor shall treat as confidential the receipt of the Suspension Notice and shall not disclose the information contained in such Suspension Notice without the prior written consent of the Company until such time as the information contained therein is or becomes available to the public generally, other than as a result of disclosure by such Investor in breach of the terms of this Agreement; provided, that the foregoing will not prohibit the Investor from trading in the Registrable Securities solely by virtue of having received a Suspension Notice and the information contained therein. An Investor may recommence effecting sales of the Registrable Securities pursuant to the Registration Statement (or such filings) following further written notice to such effect (an “Endof Suspension Notice”) from the Company, which End of Suspension Notice shall be given by the Company to the Investor promptly (but in no event later than 24 hours) following the conclusion of any Suspension Event.
Section 4. RegistrationExpenses. All expenses incident to the Company’s performance of or compliance with this Agreement, including, without limitation, all registration, qualification and filing fees, fees and expenses of compliance with securities or blue sky laws, printing expenses, messenger and delivery expenses, fees and disbursements of custodians, and fees and disbursements of counsel for the Company and all independent certified public accountants and other persons retained by the Company (all such expenses being herein called “Registration Expenses”) shall be borne by the Company. The Investors shall be responsible for the payment of all discounts and commissions incurred in connection with sales of Registrable Securities.
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Section 5. Obligationsof the Investors.
(a) From time to time, the Company may require each Investor to furnish to the Company information regarding the distribution of the Registrable Securities held by it, as shall be reasonably required to effect the registration of such Registrable Securities.
(b) The Investors, by such Investors’ acceptance of the Registrable Securities, agrees to cooperate with the Company as reasonably requested by the Company in connection with the preparation and filing of any Registration Statement hereunder.
(c) Each Investor agrees that, upon receipt of a Suspension Notice pursuant to Section 3(b), such Investor will immediately discontinue disposition of Registrable Securities pursuant to any Registration Statement(s) covering such Registrable Securities until such Investor’s receipt of the End of Suspension Notice.
(d) Each Investor covenants and agrees that it will comply with the prospectus delivery requirements of the Securities Act as applicable to it or an exemption therefrom in connection with sales of Registrable Securities pursuant to the Registration Statement.
(e) Each Investor agrees that, upon receipt of any written notice from the Company of any event as a result of which the prospectus or any document incorporated therein by reference contains an untrue statement of material fact or omits to state any material fact necessary to make the statements therein not misleading, such Investor will discontinue the distribution of Registrable Securities pursuant to any such prospectus until such Investor receives copies of a supplemented or amended prospectus from the Company. In addition, if the Company requests in writing, each Investor will deliver to the Company (at the Company’s expense) all copies, other than permanent file copies then in its possession, of the prospectus covering the Registrable Securities current at the time of receipt of the notice. Each Investor agrees not to use any free writing prospectus unless consented to by the Company.
Section 6. Indemnification.
(a) To the full extent permitted by law, the Company agrees to indemnify and hold harmless each Investor, its officers, directors, members, employees, agents, and each person who controls such Investor (within the meaning of the Securities Act and the Exchange Act) against all losses, claims, damages, liabilities, and expenses to which any of such persons may become subject in connection with any claims arising out of or resulting from any untrue or allegedly untrue statement of material fact contained in any Registration Statement, prospectus, preliminary prospectus, final prospectus or any amendment or supplement thereof, or any omission to state a material fact required to be stated therein or necessary to make the statements therein not misleading or any violation or alleged violation by the Company of the Securities Act, the Exchange Act or any rule or regulation thereunder applicable to the Company and relating to the action or inaction of the Company in connection with any registration, qualification or compliance, except to the extent the untrue statement or omission resulted from information that such Investor furnished in writing to the Company specifically for use in such Registration Statement or prospectus and was reviewed and approved in writing by such Investor; or any violation or alleged violation by the Company of any of the Securities Act or the Exchange Act or any applicable state securities laws, or any rules promulgated under any such acts or laws; provided, however, that the Company shall not be liable to any Investor in any such case to the extent that such loss, claim, damage, liability or expense is related to the use by an Investor of an outdated or defective prospectus after such party has received written notice from the Company that such prospectus is outdated or defective. As to any person entitled to indemnity under this Section 6(a), such indemnity shall remain in full force and effect regardless of any investigation made by or on behalf of such person and shall survive the transfer of the Registrable Securities by an Investor.
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(b) Each Investor will furnish to the Company in writing the information that the Company reasonably requests for use in connection with any Registration Statement or prospectus and such Investor agrees to indemnify, to the fullest extent permitted by law, the Company, its directors and officers, and each person who controls the Company (within the meaning of the Securities Act and the Exchange Act) against all losses, claims, damages, liabilities and expenses to which any of such persons may become subject under the Securities Act or the Exchange Act resulting from any untrue or allegedly untrue statement of material fact contained in any Registration Statement, prospectus, preliminary prospectus, final prospectus or any amendment or supplement thereof, or any omission to state a material fact required to be stated therein or necessary to make the statements therein not misleading, but only to the extent that the untrue statement or omission results from a statement contained in or omitted from any information such Investor furnished in writing to the Company through an instrument duly executed by such Investor specifically stating that it is for use in the preparation of such Registration Statement, prospectus or preliminary prospectus and was reviewed and approved in writing by such Investor, it being understood that Exhibit A hereto and the Selling Stockholder Questionnaire have been approved for such purpose; provided, however, that the obligations of any Investor hereunder shall be limited to an amount equal to the net proceeds actually received by such Investor from the sale of securities pursuant to the Registration Statement as contemplated herein; provided, further, however, that the obligations of an Investor shall not apply to amounts paid in settlement of any claim if such settlement is effected without the prior written consent of such Investor, which consent shall not be unreasonably withheld, conditioned or delayed. As to any person entitled to indemnity under this Section 6(b), such indemnity shall remain in full force and effect regardless of any investigation made by or on behalf of such person.
(c) Any person entitled to indemnification under this Section 6 will (x) give prompt written notice to the indemnifying party of any claim with respect to which it seeks indemnification (provided, that the failure to give prompt notice shall not impair any person’s or entity’s right to indemnification hereunder to the extent such failure has not materially prejudiced the indemnifying party) and (y) unless in the indemnifying party’s reasonable judgment a conflict of interest may exist between the indemnified and indemnifying parties with respect to the claim, permit the indemnifying party to assume the defense of the claim with counsel reasonably satisfactory to the indemnified party. The indemnifying party will not be liable for any settlement made without its written consent, which consent shall not be unreasonably withheld, conditioned or delayed. No indemnifying party will consent to entry of any judgment or will enter into any settlement that does not include as an unconditional term the claimant’s or plaintiffs release of the indemnified party from all liability concerning the claim or litigation. An indemnifying party who is not entitled to or elects not to assume the defense of a claim will not be obligated to pay the fees and expenses of more than one counsel for all parties indemnified by the indemnifying party with respect to the claim. Each indemnified party shall furnish such information regarding itself or the claim in question as an indemnifying party may reasonably request in writing and as shall be reasonably required in connection with defense of such claim and litigation resulting therefrom.
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(d) If for any reason the indemnification provided for in the preceding paragraphs (a) and (b) is unavailable to an indemnified party or insufficient to hold it harmless, other than as expressly specified therein, then the indemnifying party shall contribute to the amount paid or payable by the indemnified party as a result of such loss, claim, damage or liability in such proportion as is appropriate to reflect the relative fault of the indemnified party and the indemnifying party, as well as any other relevant equitable considerations; provided, however, that an Investor will not be required to contribute any amount in excess of the net proceeds actually received by such Investor from the sale of securities pursuant to the Registration Statement as contemplated herein. The relative fault of the indemnifying party and of the indemnified party shall be determined by reference to, among other things, whether any action in question, including any untrue or alleged untrue statement of a material fact was made by, or relates to information supplied by, the indemnifying party or the indemnified party, and the indemnifying party’s or the indemnified party’s relative intent, knowledge, access to information and opportunity to correct or prevent such action. The amount paid or payable by a party as a result of the losses, claims, damages, liabilities and expenses referred to above shall be deemed to include, subject to the limitations set forth in this Agreement, any legal or other fees, charges or expenses reasonably incurred by such party in connection with any investigation or proceeding. The parties hereto agree that it would not be just and equitable if contribution pursuant to this Section 6(d) were determined by pro rata allocation or by any other method of allocation which does not take account of the equitable considerations referred to in this Section 6(d). No person or entity guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) will be entitled to contribution from any person or entity who was not guilty of such fraudulent misrepresentation.
Section 7. Rule 144;Company Obligations. With a view to making available to the Investors the benefits of Rule 144 promulgated under the Securities Act or any other similar rule or regulation of the SEC that may at any time permit the Investors to sell securities of the Company to the public without registration, the Company agrees to use reasonable best efforts, during the Effectiveness Period to:
(a) Make and keep public information available, as those terms are understood and defined in Rule 144;
(b) File with the SEC in a timely manner (without giving effect to any extensions pursuant to Rule 12b-25 under the Exchange Act) all reports and other documents required of the Company under the Exchange Act so long as the Company remains subject to such requirements and the filing of such reports and other documents is required for the applicable provisions of Rule 144; and
(c) So long as an Investor owns Registrable Securities, promptly upon request, furnish to such Investor (i) a written statement by the Company that it has complied with the reporting requirements of the Exchange Act as required for applicable provisions of Rule 144, (ii) a copy of the most recent annual or quarterly report of the Company and such other reports and documents so filed by the Company and (iii) such other information as may be reasonably requested to permit such Investor to sell such Registrable Securities pursuant to Rule 144 without registration; provided, however, that the Company shall have no obligation to provide any document pursuant to this Section 7(c) that is available on the EDGAR system.
(d) Subject to the limitations contained herein, the Company shall use commercially reasonable efforts to facilitate the disposition by the Investors of the Registrable Securities pursuant to the Registration Statement.
Section 8. [Reserved.]
Section 9. Interpretationof this Agreement.
(a) TermsDefined. As used in this Agreement, the following terms have the respective meaning set forth below:
“Agreement” is defined in the recitals.
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“Business Day” shall mean any day other than a Saturday, a Sunday or a day on which commercial banks in New York City are required or authorized to be closed, on which the SEC is open and accepts filings, provided that any reference to “days” (unless Business Days are specified) shall mean calendar days.
“Closing Date” shall have the meaning set forth in the Purchase and Sale Agreement.
“Common Stock” is defined in the recitals.
“Company” is defined in the recitals.
“Effectiveness Period” is defined in Section 1(b).
“End of Suspension Notice” is defined in Section 3(b).
“Exchange Act” shall mean the Securities Exchange Act of 1934, as amended.
“Filing Deadline” shall mean ninety (90) days after issuance of the PIPE Shares.
“Form S-3” is defined in Section 1(a).
“Ligand” is defined in the recitals.
“Ligand PIPE Shares” is defined in the recitals.
“Ligand Stock Purchase Agreement” is defined in the recitals.
“Medtronic PIPE Shares” is defined in the recitals.
“Medtronic Stock Purchase Agreement” is defined in the recitals.
“Investor” and “Investors” are defined in the recitals.
“Permitted Transferee” shall mean, in the event of a transfer or assignment of Registrable Securities by an Investor to such Permitted Transferee, (i) an affiliate, nominee, subsidiary, parent, partner, limited partner, retired partner, member, retired member, shareholder or related party of the Investor; or (ii) after such assignment or transfer, the Permitted Transferee holds all of such assignor or transferor’s shares and rights to shares of Registrable Securities (subject to appropriate adjustment for stock splits, stock dividends, combinations and other recapitalizations).
“Person” shall mean an individual, a limited liability company, a partnership, a joint venture, a corporation, a trust, an unincorporated organization and a government or any department or agency thereof.
“PIPE Shares” is defined in the recitials.
“Proposed Filing Date” is defined in Section 2(a).
“Purchase and Sale Agreement” is defined in the recitals.
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“register,” “registered” and “registration” refer to a registration effected by preparing and filing one or more Registration Statements in compliance with the Securities Act and pursuant to Rule 415 and the declaration or ordering of effectiveness of such Registration Statement(s) by the SEC.
“Registrable Securities” shall mean (i) the Warrant Shares, (ii) the PIPE Shares and (ii) any other securities of the Company (or any successor or assign of the Company, whether by merger, reorganization, consolidation, sale of assets or otherwise) which may be issued, issuable, with respect to, in exchange for, or in substitution of, Registrable Securities referenced in the foregoing clauses (i) and (ii) by reason of any dividend, distribution or Common Stock split, combination of shares of Common Stock, merger, consolidation, recapitalization, reclassification, reorganization, sale of assets or similar transaction; provided, that a Registrable Security shall cease to be a Registrable Security when it is (x) registered under the Securities Act and disposed of in accordance with the registration statement covering it, (y) sold under Rule 144 (or any similar provisions then in force) under the Securities Act or (z) eligible for sale by the holder thereof without limitations as to volume or manner of sale pursuant to Rule 144.
“Stock Purchase Agreements” is defined in the recitals.
“Registration Expenses” is defined in Section 4.
“Registration Statement” is defined in Section 1(a), and includes the prospectus, amendments and supplements to such registration statement, including pre- and post-effective amendments, all exhibits thereto, and all material incorporated by reference or deemed to be incorporated by reference in such registration statement.
“Rule 144” shall mean Rule 144 promulgated under the Securities Act or any successor rule that may be promulgated by the SEC.
“Rule 415” shall mean Rule 415 promulgated under the Securities Act or any successor rule providing for offering securities on a continuous or delayed basis.
“SEC” shall mean the Securities and Exchange Commission.
“Securities Act” shall mean the Securities Act of 1933, as amended.
“Selling Stockholder Questionnaire” is defined in Section 2(a).
“Shares” is defined in the recitals.
“Suspension Event” is defined in Section 3(b).
“Suspension Notice” is defined in Section 3(b).
“Suspension Period” is defined in Section 3(a).
“Trading Day” shall mean any day on which the Common Stock is traded for any period on the NASDAQ Global Select Market, or if the Common Stock is no longer listed on the NASDAQ Global Select Market, on the other United States securities exchange or market on which the Common Stock is then being principally traded. If the Common Stock is not so listed or traded, then “Trading Day” means a Business Day.
“Warrants” is defined in the recitals.
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“Warrant Shares” is defined in the recitals.
(b) GoverningLaw. THIS AGREEMENT SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE DOMESTIC LAWS OF THE STATE OF NEW YORK WITHOUT REGARD TO THE CONFLICTS OF LAWS OR PRINCIPLES THEREOF THAT WOULD CAUSE THE APPLICATION OF THE LAWS OF ANY JURISDICTION OTHER THAN THE STATE OF NEW YORK. WITH RESPECT TO ANY LAWSUIT OR PROCEEDING ARISING OUT OF OR BROUGHT WITH RESPECT TO THIS AGREEMENT, OR ANY TRANSACTION CONTEMPLATED HEREBY, EACH OF THE PARTIES HERETO IRREVOCABLY (a) SUBMITS TO THE EXCLUSIVE JURISDICTION OF THE UNITED STATES FEDERAL AND NEW YORK STATE COURTS LOCATED IN THE COUNTY OF NEW YORK IN THE STATE OF NEW YORK; (b) WAIVES ANY OBJECTION IT MAY HAVE AT ANY TIME TO THE LAYING OF VENUE OF ANY PROCEEDING BROUGHT IN ANY SUCH COURT; (c) WAIVES ANY CLAIM THAT SUCH PROCEEDING HAS BEEN BROUGHT IN AN INCONVENIENT FORUM; AND (d) FURTHER WAIVES THE RIGHT TO OBJECT, WITH RESPECT TO SUCH PROCEEDINGS, THAT SUCH COURT DOES NOT HAVE JURISDICTION OVER SUCH PART.
(c) Section Headings. The headings of the sections and subsections of this Agreement are inserted for convenience only and shall not be deemed to constitute a part thereof.
Section 10. Miscellaneous.
(a) Notices.
(i) Any notices, consents, waivers or other communications required or permitted to be given under the terms of this Agreement must be in writing and will be deemed to have been delivered: (i) upon receipt, when delivered personally; (ii) when sent, if sent by email (provided that such sent email is kept on file (whether electronically or otherwise) by the sending party and the sending party does not receive an automatically generated message from the recipient’s email server that such email could not be delivered to such recipient); or (iii) one (1) Business Day after deposit with a nationally recognized overnight delivery service, in each case properly addressed to the party to receive the same. The addresses and facsimile numbers for such communications shall be:
If to the Company:
Orchestra BioMed Holdings, Inc.
150 Union Square Drive
New Hope, Pennsylvania 18938
Attention: [Omitted Pursuant to Item 601(a)(6)]
Email: [Omitted Pursuant to Item 601(a)(6)]
with a copy to (which shall not constitute notice):
Paul Hastings LLP
200 Park Avenue
New York, NY 10166
Attention: [Omitted Pursuant to Item 601(a)(6)]
Email: [Omitted Pursuant to Item 601(a)(6)]
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If to an Investor, to the address set forth on such Investor’s signature page hereto.
or to such other physical or email address and/or to the attention of such other Person as the recipient party has specified by written notice given to each other party five (5) days prior to the effectiveness of such change. Written confirmation of receipt (A) given by the recipient of such notice, consent, waiver or other communication, (B) electronically generated by the sender’s email containing the time, date, recipient email address of such transmission or (C) provided by an overnight courier service shall be rebuttable evidence of personal service, receipt by email or receipt from an overnight courier service in accordance with clause (i), (ii) or (iii) above, respectively.
(b) Reproductionof Documents. This Agreement and all documents relating thereto, including, without limitation, consents, waivers and modifications which may hereafter be executed, documents received by the Investors pursuant hereto and financial statements, certificates and other information previously or hereafter furnished to the Investors, may be reproduced by the Investors by a photographic, photostatic, microfilm, microcard, miniature photographic or other similar process and the Investors may destroy any original document so reproduced. All parties hereto agree and stipulate that any such reproduction shall be admissible in evidence as the original itself in any judicial or administrative proceeding (whether or not the original is in existence and whether or not such reproduction was made by the Investors in the regular course of business) and that any enlargement, facsimile or further reproduction of such reproduction shall likewise be admissible in evidence.
(c) Successorsand Assigns. The Agreement will inure to the benefit of and be binding on the parties hereto and their respective successors and permitted assigns. An Investor may assign its rights and obligations hereunder to any transferee or assignee of its Registrable Securities who is a Permitted Transferee, provided that the Company is, within a reasonable time after such assignment or transfer, furnished with written notice of the name and address of such Permitted Transferee and the Registrable Securities with respect to which such rights and obligations are being assigned, and, provided further, that such Permitted Transferee enters into an agreement to be bound by the terms of this Agreement in the form of the Joinder Agreement attached hereto as Exhibit D. Any such transfer to a Permitted Transferee must be in compliance with the Securities Act and any other applicable securities or blue sky laws. By delivering an executed Joinder Agreement, such Permitted Transferees shall be deemed to be a party hereto and such Joinder Agreement shall be a part of this Agreement.
(d) EntireAgreement; Amendment and Waiver. This Agreement constitutes the entire understanding of the parties hereto relating to the subject matter hereof and supersedes all prior understandings among such parties. The Agreement may be amended, supplemented or otherwise modified only by a written instrument executed by the Company and the Investors. No waiver of the provisions of the Agreement will be effective unless explicitly set forth in writing and executed by the Company and the Investors. Except as provided in the preceding sentence, no action taken pursuant to the Agreement, including without limitation, any investigation by or on behalf of any party, will be deemed to constitute a waiver by the party taking such action of compliance with any covenants or agreements contained herein. The waiver by any party hereto of a breach of any provision of the Agreement will not operate or be construed as a waiver of any subsequent breach.
(e) Severability. In the event that any part or parts of this Agreement shall be held illegal or unenforceable by any court or administrative body of competent jurisdiction, such determination shall not affect the remaining provisions of this Agreement which shall remain in full force and effect.
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(f) ThirdParties. Except as otherwise set forth herein, the Agreement does not create any rights, claims or benefits inuring to any person that is not a party thereto nor create or establish any third party beneficiary thereto.
(g) SpecificPerformance. Without limiting or waiving in any respect any rights or remedies of the parties hereto under the Agreement, each of the parties will be entitled to seek specific performance of the obligations to be performed by the other in accordance with the provisions of the Agreement. The Company and the Investors hereby declare that it is impossible to measure in money the damages which will accrue to the parties hereto by reason of the failure of any party to perform any of its obligations under this Agreement. If any party hereto shall institute any action or proceeding to enforce the provisions hereof, the Company and each of the Investors hereby waive the claim or defense that the party instituting such action or proceeding has an adequate remedy at law.
(h) Counterparts. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original and all of which together shall be considered one and the same agreement. Electronic signatures complying with the New York Electronic Signatures and Records Act (N.Y. State Tech. §§ 301-309), as amended from time to time, or other applicable law will be deemed original signatures for purposes of this Agreement. Transmission by telecopy, electronic mail or other transmission method of an executed counterpart of this Agreement will constitute due and sufficient delivery of such counterpart.
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IN WITNESS WHEREOF, this Registration Rights Agreement has been executed by the parties as of the date first above written.
| THE COMPANY | |
|---|---|
| ORCHESTRA BIOMED HOLDINGS INC. | |
| By: | |
| Name:<br> Andrew Taylor | |
| Title:<br> Chief Financial Officer |
[Signature Page to RegistrationRights Agreement]
| INVESTOR: | |
|---|---|
| LIGAND PHARMACEUTICALS INCORPORATED | |
| By: | |
| Name: | |
| Title: | |
| Address: | |
| Email: |
[Signature Page to RegistrationRights Agreement]
| INVESTOR: | |
|---|---|
| COVIDIEN GROUP S.À.R.L. | |
| By: | |
| Name: | |
| Title: | |
| c/o Medtronic, Inc. | |
| --- | --- |
| Medtronic Operational Headquarters | |
| 710 Medtronic Parkway | |
| Minneapolis, Minnesota 55432-5604 | |
| Attention: | [Omitted Pursuant to Item 601(a)(6)] |
| Email: | [Omitted Pursuant to Item 601(a)(6)] |
| with a copy to (which shall not constitute notice): | |
| Fredrikson & Byron, P.A. | |
| 200 South Sixth Street, Suite 4000 | |
| Minneapolis, MN 55402 | |
| Attention: [Omitted Pursuant to Item 601(a)(6)] | |
| Email: [Omitted Pursuant to Item 601(a)(6)] |
[Signature Page to RegistrationRights Agreement]
EXHIBIT A
PLAN OF DISTRIBUTION
A-1
EXHIBIT B
SELLING STOCKHOLDER
B-1
EXHIBIT C
SELLING STOCKHOLDER NOTICE AND QUESTIONNAIRE
C-1
EXHIBIT D
JOINDER AGREEMENT
By executing this JOINDER AGREEMENT, the undersigned hereby agrees to become a party to the Registration Rights Agreement dated as of [●], 2025, by and among Orchestra BioMed Holdings, Inc., a Delaware corporation, and the Investors party thereto, and that he/she/it will have all the rights and obligations of an Investor provided under such Registration Rights Agreement.
| Dated: | [NAME] | |
|---|---|---|
| By: | ||
| Name: | ||
| Title: | ||
| Address: | ||
| Email: | ||
| Facsimile No.: |
[Joinder to Registration Rights Agreement]
D-1
Exhibit 99.1
Ligand and Medtronic Commit $70 Million in StrategicCapital to Orchestra BioMed
· Ligand to invest $35 million in exchange for a tiered royalty on future sales of Orchestra’s AVIM
therapy and Virtue SAB and an additional $5 million in an equity private placement
· Medtronicto invest $10 million in an equity private placement and an additional $20 million in a
secured subordinated promissory note convertibleto prepaid revenue share
· Medtronic and Orchestra BioMed expand strategic collaboration to provide pathway for
development of AVIM therapy-enabled leadless pacemakers
NEW HOPE, Pa., July 31, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced that the Company has secured $70 million in new capital from Ligand Pharmaceuticals Incorporated (Nasdaq: LGND, “Ligand”) and Medtronic, plc. (NYSE: MDT, “Medtronic”) to advance its late-stage partnered cardiology programs.
Simultaneously, Orchestra BioMed and Medtronic, which have an existing strategic collaboration for atrioventricular interval modulation (“AVIM”) therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients, have amended their agreement to include the potential future development of AVIM therapy-enabled leadless pacemakers. Unlike traditional pacemakers that are placed in a patient's chest with leads (or wires) running to the heart, minimally-invasive Medtronic Micra™ leadless pacemakers are implanted directly into the heart, reducing potential sources of complications.
Ligand $40 million Investment
ToddDavis, Chief Executive Officer of Ligand commented: “We are pleased to partner with Medtronic and Orchestra BioMed in this important endeavor. This investment expands our pipeline of development-stage products and demonstrates our confidence in Orchestra BioMed’s scientific advancements, as well as the strong capabilities of its partner, Medtronic. We are proud to support Orchestra BioMed as they develop novel high-impact, device-based therapies such as AVIM therapy and Virtue SAB targeting high-risk patient populations with hypertension and arterial disease, two of the most significant global health challenges.”
DavidHochman, Chairman and Chief Executive Officer of Orchestra BioMed stated, “Ligand has been one of the inspirations for our partnership-driven approach to creating long-term, capital-efficient value through royalty-based collaborations. We are thrilled to welcome them as a strategic capital partner. Ligand’s decision to invest in our partnered programs and our team reflects our shared conviction in the transformative potential of both AVIM therapy and Virtue SAB – our late-stage flagship technologies aimed to address important unmet medical needs in large, established global markets. This transaction provides foundational financial support to enable our potential achievement of key value creating milestones for both of our high-impact clinical programs.”
Under the terms of the agreement, Ligand will pay $20 million to Orchestra BioMed at closing with an additional $15 million to be funded, subject to certain conditions precedent, at the nine-month anniversary of the transaction closing date. Ligand has also agreed to invest an additional $5 million to purchase shares of the Company’s common stock in an equity private placement at the public offering price per share in Orchestra BioMed’s next public offering of its equity securities. In exchange, Ligand will receive a low double-digit royalty on the first $100 million in commercial revenues from Orchestra’s AVIM therapy and Virtue SAB programs in all indications. Ligand will also earn a mid-single-digit royalty on annual revenues exceeding $100 million in commercial revenues from AVIM therapy in the uncontrolled hypertension and increased cardiovascular risk indication and Virtue SAB in coronary artery disease indications.
Medtronic $30 million Additional Investment & Future Leadless AVIM Therapy Device Development
RobertC. Kowal, M.D., Ph.D., Vice President and General Manager of Cardiac Pacing Therapies within the Medtronic Cardiac Rhythm Management operatingunit, commented: “Our expanded investment in Orchestra BioMed reflects confidence in their clinical progress. Broadening our collaboration to include integrating AVIM therapy into future leadless pacing technology reaffirms our commitment to transform care for patients who need pacing therapy and have uncontrolled hypertension.”
Mr.Hochman added, “Medtronic continues to be an outstanding partner for the AVIM therapy program. We believe their $30 million additional commitment to Orchestra BioMed reflects their belief in the clinical and commercial potential for this therapy to benefit patients with uncontrolled hypertension and increased cardiovascular risk in the pacemaker population. Expanding our existing collaboration to provide for potential future integration of AVIM therapy into a leadless pacemaker system deepens our strategic alignment and creates a potential pathway for patients to benefit from both AVIM therapy and cutting-edge leadless pacing technology, simultaneously.”
Subject to the terms of the agreement, Medtronic’s $30 million additional investment commitment to Orchestra BioMed includes a $10 million agreement to purchase shares of the Company’s common stock in a private placement at the public offering price in the Company’s next public offering of its equity securities. Medtronic also made a $20 million commitment to purchase a five-year term secured subordinated promissory note, to be funded in nine months which automatically converts to a prepaid revenue share upon U.S. Food and Drug Administration (“FDA”) approval of AVIM therapy. The prepaid revenue share will be credited back to Medtronic at a low double-digit percentage of actual AVIM therapy revenue share paid to Orchestra BioMed, up to $40 million in cumulative revenue share.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company enabling scientific advancement through supporting the clinical development of high-value medicines. Ligand does this by providing financing, licensing our technologies or both. Ligand’s business model seeks to generate value for stockholders by creating a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Ligand’s goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable and diversified manner. Ligand’s business model is based on funding programs in mid- to late-stage drug development in return for economic rights, purchasing royalty rights in development stage or commercial biopharmaceutical products and licensing its technology to help partners discover and develop medicines. Ligand partners with other pharmaceutical companies to attempt to leverage what they do best (late-stage development, regulatory management and commercialization) in order to generate revenue. Ligand operates two infrastructure-light royalty generating technology IP platform technologies. Ligand’s Captisol® platform technology is a chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand’s NITRICIL™ platform technology facilitates tunable dosing, permitting an adjustable drug release profile to allow proprietary formulations that target a broad range of indications. Ligand has established multiple alliances, licenses and other business relationships with the world’s leading pharmaceutical companies including Amgen, Merck, Pfizer, Jazz, Gilead Sciences and Baxter International. For more information, please visit www.ligand.com. Follow Ligand on X and LinkedIn.
Ligand uses its investor relations website and X as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD. Investors should monitor our website and our X account, in addition to following our press releases, SEC filings, public conference calls and webcasts.
About Orchestra BioMed
Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s lead product candidate is AVIM therapy for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed is also developing Virtue SAB for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. The Company has received four Breakthrough Device Designations from the FDA across these two core programs, reflecting the significant potential of its technologies to address high unmet needs in cardiovascular care. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn.
References to Websites and Social Media Platforms
References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release.
About AVIM Therapy
AVIM therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will further evaluate the safety and efficacy of AVIM therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM therapy has been granted Breakthrough Device Designation by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk.
About Virtue SAB
Virtue SAB is designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™ through a non-coated microporous AngioInfusion™ Balloon that protects the drug in transit to consistently deliver a large liquid dose overcoming certain limitations of drug-coated balloons. SirolimusEFR delivered by Virtue SAB has been shown in published preclinical series involving hundreds of arterial deliveries to achieve sustained tissue levels well above the known required therapeutic tissue concentration for inhibiting restenosis (1 ng/mg tissue) for the entire critical healing period of approximately 30 days. Virtue SAB demonstrated positive three-year clinical data in coronary ISR in the SABRE study, a multi-center prospective, independent core lab-adjudicated clinical study of 50 patients conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for specific indications relating to coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee.
Forward-Looking Statements
Certain statements included in this press releasethat are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States PrivateSecurities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trendsor that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relatingto the enrollment, implementation and design of the Company’s planned and ongoing pivotal trials, realizing the clinical and commercialvalue of the Company’s product candidates, the potential safety and efficacy of the Company’s product candidates, the abilityof the Company’s partnerships to accelerate clinical development, and the Company’s ability to satisfy funding and closingconditions of the transactions described in this press release. These statements are based on various assumptions, whether or not identifiedin this press release, and on the current expectations of the Company’s management and are not predictions of actual performance.These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied onas a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficultor impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company.These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business,market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidatesand ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieveexpected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussedunder the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31,2024, which was filed with the SEC on March 31, 2025 and the risk factor discussed under the heading “Item 1A. Risk Factors”in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, which was filed with the SEC on May12, 2025.
The Company operates in a very competitiveand rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions againstplacing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does notplan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law.
Contacts
For Orchestra BioMed:
Investors:
Silas Newcomb
Snewcomb@orchestrabiomed.com
Media:
Kelsey Kirk-Ellis
Kkirkellis@orchestrabiomed.com
For Ligand:
Investors:
Melanie Herman
investors@ligand.com
(858) 550-7761
Media:
Kellie Walsh
media@ligand.com
(914) 315-6072