Summit Therapeutics Inc 8-K, filed Sep 29, 2026
Summit Therapeutics Inc. (SMMT)
About this 8-K
Summit Therapeutics Inc filed this 8-K on September 29, 2026, reporting on events of September 28, 2026.
Items reported
- Item 1.01: Entered into a material agreement
- Item 3.02: Unregistered sale of equity
- Item 5.03: Charter or bylaw amendment, or fiscal year change
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 1.01 | Entry into a Material Definitive Agreement. |
On September 28, 2026, Summit Therapeutics Inc. (the “Company”) entered into a securities purchase agreement (the “Purchase Agreement”) with AstraZeneca Holdings B.V. (the “Investor”), a subsidiary of AstraZeneca plc, for the issuance and sale by the Company of 108,955.3686 shares (the “Preferred Shares”) of the Company’s newly designated Class A Convertible Preferred Stock, par value $0.01 per share (the “Class A Preferred Stock”), at a purchase price of $18,356.14 per Preferred Share, for aggregate gross proceeds to the Company of $2.0 billion (the “Private Placement”). Each share of Class A Preferred Stock will be convertible into 1,000 shares (the “Conversion Ratio”) of Common Stock of the Company, par value $0.01 per share (the “Common Stock”). The Class A Preferred Stock purchase price is based on a price per share of Common Stock of $18.3561. For a description of the terms of the Class A Preferred Stock, see Item 5.03 below.
The closing of the Private Placement is expected to occur within five business days of the date of the Purchase Agreement, subject to the satisfaction of certain customary closing conditions. The Purchase Agreement contains customary representations, warranties and covenants by the Company, customary indemnification obligations of the Company, other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Purchase Agreement were made only for purposes of the Purchase Agreement and as of specific dates, were solely for the benefit of the parties to such agreement and were subject to limitations agreed upon by the contracting parties. The Purchase Agreement also provides the Investor with certain preemptive rights, as well as certain rights in the event a third party submits an acquisition proposal to the Company, in each case as provided in the Purchase Agreement.
The Preferred Shares issuable pursuant to the Purchase Agreement and any shares of Common Stock issuable upon the conversion of the Preferred Shares (the “Conversion Shares”) will be issued in reliance on the exemption from registration requirements of the Securities Act of 1933, as amended (the “Securities Act”) provided by Section 4(a)(2) of the Securities Act and/or Rule 506 of Regulation D promulgated under the Securities Act. The Company is relying on these exemptions from registration based in part on representations made by the Investor.
In connection with the closing of the Private Placement, the Company will enter into a Registration Rights Agreement with the Investor (the “Registration Rights Agreement”). The Registration Rights Agreement provides, among other things, that the Company will as soon as reasonably practicable, and in any event by no later than 60 days after the closing of the Private Placement, file with the Securities and Exchange Commission (the “SEC”) a registration statement registering the resale of the Conversion Shares. The Company has agreed to use its reasonable best efforts to have such registration statement declared effective as soon as practicable after the filing thereof.
The foregoing descriptions of the Purchase Agreement and the Registration Rights Agreement do not purport to be complete and are qualified in their entirety by reference to the full text of the Purchase Agreement and the form of Registration Rights Agreement, copies of which are filed as Exhibits 10.1 and 10.2 to this Current Report on Form 8-K, respectively, and are incorporated herein by reference.
| Item 3.02 | Unregistered Sales of Equity Securities. |
The information contained in Item 1.01 of this Current Report on Form 8-K regarding the Private Placement is incorporated by reference in this Item 3.02.
| Item 5.03 | Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year |
In connection with the Private Placement, on September 28, 2026, the Company filed a Certificate of Designation with the Secretary of State of the State of Delaware (the “Certificate of Designation”). The Certificate of Designation authorizes the issuance of 108,956 shares of Class A Convertible Preferred Stock. The following is a description of the material terms of the Class A Preferred Stock as set forth in the Certificate of Designation.
Conversion. The Class A Preferred Stock will be convertible at the option of the holder into a number of shares of Common Stock equal to the Conversion Ratio, provided that no holder shall have the right to exercise such conversion right until the later of (i) if applicable, the expiration or termination of any applicable waiting period (or any extension thereof) under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations promulgated thereunder and (ii) the effectiveness of the amendment to the Company’s Restated Certificate of Incorporation, as amended, increasing the number of shares of the Common Stock that the Company is authorized to issue to a number sufficient to permit the issuance in full of the shares of Common Stock issuable upon conversion of the shares of Class A Preferred Stock (the “Authorized Share Increase Charter Amendment”). The Class A Preferred Stock will also convert automatically upon a Change of Control and a Qualified Sale (each as defined in the Certificate of Designation), subject to the terms and conditions of the Certificate of Designation.
Dividends. Each holder of Class A Preferred Stock will be entitled to receive dividends in the same manner as holders of Common Stock, as determined on an as-converted basis, as if all outstanding shares of Class A Preferred Stock had been converted pursuant to the terms of the Certificate of Designation as of immediately prior to the record date of the applicable dividend.
Voting Rights. Except as otherwise required by law, the Class A Preferred Stock will have no voting rights. The Company may not alter or change adversely the powers, preferences or rights of the Class A Preferred Stock or alter or amend the Certificate of Designation without the affirmative vote or consent of a majority of the outstanding shares of Class A Preferred Stock.
Dissolution, Liquidation or Winding Up. In connection with a dissolution, liquidation or winding up of the Company, distributions to the stockholders of the Company will be made among the holders of Class A Preferred Stock and Common Stock pro rata in proportion to the number of shares held by each such holder, with shares of Class A Preferred Stock treated as if they had been converted to Common Stock pursuant to the terms of the Certificate of Designation immediately prior to such event (provided that holders of the Class A Preferred Stock shall be entitled to receive a cash payment in the amount of $0.01 per share of Class A Preferred Stock prior to the pro rata distribution).
Redemption. If the Authorized Share Increase Charter Amendment has not become effective within 18 months of the date on which the shares of Class A Preferred Stock are initially issued (the “Amendment Deadline”), the Company is required to redeem all outstanding shares of Class A Preferred Stock for cash at a redemption price reflecting the then-prevailing market value of the Common Stock underlying the Preferred Shares, calculated as set forth in the Certificate of Designation. The redemption price will be payable on or before the fifth business day after the Amendment Deadline.
The foregoing description of the Class A Preferred Stock does not purport to be complete and is qualified in its entirety by reference to the full text of the Certificate of Designation, which is filed as Exhibit 3.1 to this Current Report on Form 8-K and is incorporated herein by reference.
| Item 8.01 | Other Items. |
On September 28, 2026, the Company issued a press release announcing the Private Placement, a copy of which is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
On September 28, 2026, a Subsidiary of the Company entered into a separate clinical trial collaboration agreement with the Investor to evaluate sonesitatug vedotin (sone-ve) in combination with ivonescimab.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit |
Description | |
| 3.1 | Certificate of Designation | |
| 10.1 | Securities Purchase Agreement, dated September 28, 2026, by and between Summit Therapeutics Inc. and AstraZeneca Holdings B.V. | |
| 10.2† | Form of Registration Rights Agreement | |
| 99.1 | Press Release dated September 28, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
| † | Certain of the exhibits and schedules to this exhibit have been omitted in accordance with Regulation S-K Item 601(a)(5). The Company agrees to furnish supplementally a copy of all omitted exhibits and schedules to the SEC upon its request. |
Forward Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “suggest,” “target,” “on track,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this Current Report on Form 8-K are forward-looking statements. These forward-looking statements include, but are not limited to, statements about: the risk that the Private Placement does not close on the anticipated timeline or at all, including because required regulatory clearances are not obtained or other closing conditions are not satisfied; dilution to existing stockholders, and potential adverse effects on the market price of the Company’s common stock, including from future sales by the Investor; the Company’s broad discretion over the use of proceeds, and the possibility that the proceeds will not be sufficient to fund operations as long as anticipated; the Investor’s ownership and contractual rights, including Third Party acquisition participation, and registration rights, and potential conflicts of interest; the completion of the Private Placement does not depend on the parties entering into a definitive collaboration agreement; uncertainties inherent in clinical development, including trial design, regulatory feedback, enrollment, timing, cost, and the possibility that the proposed clinical trials do not show favorable safety or efficacy; the possibility that earlier or preliminary results are not predictive of future results; the risk that regulatory authorities do not approve ivonescimab alone or in combination, on a timely basis or at all; the Company’s reliance on the Investor for the supply of the Investor’s products and other contributions to the clinical trials; risks relating to intellectual property, data ownership, and data-sharing under any collaboration; the possibility that any collaboration is modified, suspended, or terminated; competition, including from the Investor or its other collaborators; and the Company’s need for additional capital. These and other risks are described in greater detail under the section titled “Risk Factors” contained in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the Company’s other filings with the SEC. Any forward-looking statements that the Company makes in this Current Report on Form 8-K are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this Current Report on Form 8-K. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
SIGNATURE
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.
| SUMMIT THERAPEUTICS INC. | ||||||
| Date: September 28, 2026 |
By: | /s/ Manmeet S. Soni | ||||
| Chief Operating Officer, Chief Financial Officer and Director | ||||||
| (Principal Financial Officer) | ||||||
Exhibit 3.1
CERTIFICATE OF DESIGNATION OF PREFERENCES, RIGHTS AND LIMITATIONS
OF
CLASS A CONVERTIBLE PREFERRED STOCK
OF
SUMMIT THERAPEUTICS INC.
Pursuant to Section 151 of the General Corporation Law of the State of Delaware (as amended, supplemented or restated from time to time, the “DGCL”), SUMMIT THERAPEUTICS INC., a corporation organized and existing under the laws of the State of Delaware (the “Corporation”), in accordance with the provisions of Section 103 of the DGCL, DOES HEREBY CERTIFY:
That, the Restated Certificate of Incorporation (as the same has been amended, restated, or amended and restated to date, the “Certificate of Incorporation”) of the Corporation, as filed with the Secretary of State of the State of Delaware, authorizes the issuance of 1,020,000,000 shares of capital stock, consisting of 1,000,000,000 shares of common stock, par value $0.01 per share (“Common Stock”), and 20,000,000 shares of preferred stock, par value $0.01 per share (“Preferred Stock”);
That, subject to the provisions of the Certificate of Incorporation and the limitations prescribed by law, the board of directors of the Corporation (the “Board”) is authorized to provide by resolution and by causing the filing of a certificate of designations for the issuance of the shares of Preferred Stock in one or more series, and to establish from time to time the number of shares to be included in each such series, and to fix the designations, powers, preferences, and relative, participating, optional or other rights, if any, and the qualifications, limitations or restrictions, if any, of the shares of each such series; and
That, on September 25, 2026, the Board adopted the following resolution designating a new series of Preferred Stock as “Class A Convertible Preferred Stock”:
RESOLVED, that, in accordance with the provisions of Article FOURTH, Section B of the Certificate of Incorporation and the provisions of Section 151 of the DGCL, a series of Preferred Stock of the Corporation is hereby authorized, and the number of shares to be included in such series, and the designations, powers, preferences, and relative, participating, optional or other rights, if any, and the qualifications, limitations or restrictions, if any, of the shares of Preferred Stock included in such series, shall be as follows:
Section 1. Definitions. For the purposes hereof, the following terms shall have the following meanings:
“Affiliate” means any person or entity that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control with a person or entity, as such terms are used in and construed under Rule 144 under the U.S. Securities Act of 1933, as amended.
“Amendment Deadline” has the meaning set forth in Section 8.
“Authorized Increase Amendment” means an amendment to the Certificate of Incorporation increasing the total number of shares of Common Stock that the Company is authorized to issue to not fewer than 1,250,000,000 shares (and in any event to a number sufficient to permit the issuance in full of the Conversion Shares taking into account all shares of Common Stock then outstanding and duly reserved for issuance by the Board).
“Business Day” means any day except any Saturday, any Sunday, any day which is a federal legal holiday in the United States or any day on which banking institutions in the State of New York, Amsterdam, the Netherlands or London, United Kingdom are authorized or required by law or other governmental action to close.
“Change of Control” means (a) any transaction or series of related transactions in which any person or group (other than any holder of Class A Preferred Stock, any of its affiliates or any group in which it is a member) acquires beneficial ownership of more than 50% of the voting power of the Corporation, (b) a sale of all or substantially all of the Corporation’s assets, (c) any merger, consolidation, or similar business combination transaction involving the Corporation after which the stockholders of the Corporation immediately prior to such transaction hold less than a majority of the voting power of the surviving or resulting entity or (d) the Common Stock ceases to be listed on any National Exchange (other than pursuant to a Deemed Liquidation);.
“Class A Preferred Stock” has the meaning set forth in Section 2(a).
“Common Stock” means the Corporation’s common stock, par value $0.01 per share, and stock of any other class of securities into which such securities may hereafter be reclassified into.
“Common Stock Equivalents” means any securities of the Corporation or the subsidiaries of the Corporation, whether or not vested or otherwise convertible or exercisable into shares of Common Stock at the time of such issuance, which would entitle the holder thereof to acquire at any time Common Stock, including, without limitation, any debt, preferred stock, rights, options, warrants or other instrument that is at any time exercisable for, convertible into, or exchangeable for, or otherwise entitles the holder thereof to receive, Common Stock.
“Conversion Date” has the meaning set forth in Section 6(d).
“Conversion Ratio” means, for each share of Class A Preferred Stock, 1,000 shares of Common Stock, subject to adjustment pursuant to Section 7 hereof.
“Conversion Shares” means, collectively, the shares of Common Stock issuable upon conversion of the shares of Class A Preferred Stock in accordance with the terms hereof.
“Deemed Liquidation Event” means (a) a merger or consolidation in which (i) the Corporation is a constituent party or (ii) a subsidiary of the Corporation is a constituent party and the Corporation issues shares of its capital stock pursuant to such merger or consolidation, except any such merger or consolidation involving the Corporation or a subsidiary in which the shares of capital stock of the Corporation outstanding immediately prior to such merger or consolidation continue to represent, or are converted into or exchanged for shares of capital stock that represent, immediately following such merger or consolidation, at least a majority,
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by voting power, of the capital stock of (1) the surviving or resulting corporation, or (2) if the surviving or resulting corporation is a wholly owned subsidiary of another corporation immediately following such merger or consolidation, the parent corporation of such surviving or resulting corporation; or (b) the sale, lease, transfer, exclusive license or other disposition, in a single transaction or series of related transactions, by the Corporation or any subsidiary of the Corporation of all or substantially all the assets of the Corporation and its subsidiaries taken as a whole, or the sale or disposition (whether by merger, consolidation or otherwise) of one or more subsidiaries of the Corporation if substantially all of the assets of the Corporation and its subsidiaries taken as a whole are held by such subsidiary or subsidiaries, except where such sale, lease, transfer, exclusive license or other disposition is to the Corporation or a wholly owned subsidiary of the Corporation.
“DGCL” shall mean the General Corporation Law of the State of Delaware.
“Holder” means a holder of the Class A Preferred Stock.
“HSR Act” means Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations promulgated thereunder.
“Initial Issue Date” means the initial date on which the shares of Class A Preferred Stock are issued.
“Last Reported Sale Price” of the Common Stock on any date means the closing sale price per share (or if no closing sale price is reported, the average of the bid and ask prices or, if more than one in either case, the average of the average bid and the average ask prices) on that date as reported in composite transactions for the principal U.S. national or regional securities exchange on which the Common Stock is traded.
“Liquidation” has the meaning set forth in Section 5.
“Market Disruption Event” means (a) a failure by the primary U.S. national or regional securities exchange or market on which the Common Stock is listed or admitted for trading to open for trading during its regular trading session or (b) the occurrence or existence prior to 1:00 p.m., New York City time, on any day that is scheduled to be a Trading Day for the Common Stock for more than one half-hour period in the aggregate during regular trading hours of any suspension or limitation imposed on trading (by reason of movements in price exceeding limits permitted by the relevant stock exchange or otherwise) in the Common Stock or in any options contracts or futures contracts relating to the Common Stock.
“National Exchange” means any of the following markets or exchanges on which the Common Stock is listed or quoted for trading on the date in question, together with any successor thereto: the NYSE American, The New York Stock Exchange, the Nasdaq Global Market, the Nasdaq Global Select Market and the Nasdaq Capital Market.
“Person” means any individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, limited liability company, joint stock company, government (or an agency or subdivision thereof) or other entity of any kind.
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“Qualified Sale” means the sale of Class A Preferred Stock to a non-Affiliate of the Holder. For avoidance of doubt, a written (including any electronic) communication from a broker-dealer that a Holder has placed a sell order for shares of Common Stock issuable upon conversion of Class A Preferred Stock, or an executed copy of a stock purchase agreement with a non-Affiliate of the Holder, shall be deemed to evidence a Qualified Sale. If applicable, any Qualified Sale must be in compliance with the HSR Act.
“Trading Day” means a day on which (x) there is no Market Disruption Event and (y) trading in the Common Stock generally occurs on the Nasdaq Global Market or, if the Common Stock is not then listed on the Nasdaq Global Market, on the principal other U.S. national or regional securities exchange on which the Common Stock is then listed or, if the Common Stock is not then listed on a U.S. national or regional securities exchange, on the principal other market on which the Common Stock is then listed or admitted for trading. If the Common Stock is not so listed or admitted for trading, “Trading Day” means a Business Day.
“VWAP” per share of Common Stock on any Trading Day means the per share volume-weighted average price as displayed on Bloomberg page “SMMT <Equity> AQR” (or its equivalent successor if such page is not available) in respect of the period from 9:30 a.m. to 4:00 p.m., New York City time (or, if the scheduled close of trading of the primary session for the primary U.S. national or regional securities exchange or market on which Common Stock is listed or admitted for trading on such Trading Day is earlier, such earlier scheduled close of trading), on such Trading Day; or, if such price is not available, “VWAP” means the market value per share of Common Stock on such Trading Day as determined, using a volume-weighted average method, by a nationally recognized independent investment banking firm retained by the Corporation for this purpose.
Section 2. Designation, Amount and Par Value; Assignment.
(a) The shares of the series of Preferred Stock designated by this Certificate of Designation are designated as the Corporation’s Class A Convertible Preferred Stock (the “Class A Preferred Stock”). The number of authorized shares of Class A Preferred Stock so designated shall be 108,956. That number from time to time may be increased or decreased but not below the number of shares of Class A Preferred Stock then outstanding by further resolution duly adopted by the Board, or any duly authorized committee thereof and by the filing of a certificate pursuant to the provisions of the DGCL stating that such increase or decrease, as applicable, has been so authorized.
(b) The Corporation shall register shares of the Class A Preferred Stock, upon records to be maintained by the Corporation’s transfer agent for that purpose (the “Class A Preferred Stock Register”), in the name of the Holders thereof from time to time. The Corporation and its transfer agent may deem and treat the registered Holder of shares of Class A Preferred Stock as the absolute owner thereof for the purpose of any conversion thereof and for all other purposes. Shares of Class A Preferred Stock may be issued solely in book-entry form. The Corporation or its transfer agent shall register the transfer of any shares of Class A Preferred Stock in the Class A Preferred Stock Register, upon surrender of the shares of Class A Preferred Stock evidencing such shares to be transferred, to the Corporation’s transfer agent. Upon any such registration or transfer, a new book-entry notation evidencing the shares of Class A Preferred Stock so transferred shall be issued to the transferee and a new book-entry notation evidencing the remaining portion of the shares not so transferred, if any, shall be issued to the transferring Holder.
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Section 3. Dividends. If the Corporation declares or pays a dividend or distribution on the Common Stock for which no adjustment to the Conversion Ratio is provided under Section 7, the Corporation shall simultaneously declare and pay a dividend on the Class A Preferred Stock on a pro rata basis with the Common Stock (as determined on an as-converted basis assuming all outstanding shares of Class A Preferred Stock have been converted pursuant to the terms of this Certificate of Designation as of immediately prior to the record date of the applicable dividend (or if no record date is fixed, the date as of which record holders of Common Stock entitled to receive such dividends are to be determined)).
Section 4. Voting Rights.
(a) The Corporation shall not, without the affirmative vote or consent of a majority of the outstanding shares of Class A Preferred Stock, alter or change adversely the powers, preferences or rights of the Class A Preferred Stock or alter or amend (including by merger, consolidation or otherwise) this Certificate of Designation.
(b) Except as otherwise provided herein or as otherwise required by law, the Class A Preferred Stock shall have no voting rights.
Section 5. Liquidation. In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Corporation, or Deemed Liquidation Event (other than in connection with a Change of Control) (any such event, a “Liquidation”), the assets of the Corporation available for distribution to its stockholders shall be distributed among the holders of the shares of Class A Preferred Stock and Common Stock pro rata based on the number of shares held by each such holder, treating for this purpose all shares of Class A Preferred Stock as if they had been converted to Common Stock pursuant to the terms of this Certificate of Designation immediately prior to such Liquidation, without regard to any limitations on conversion set forth herein or otherwise and without regard as to whether sufficient shares of Common Stock are available out of the Corporation’s authorized but unissued stock for the purpose of effecting the conversion of the Class A Preferred Stock; provided that holders of the Class A Preferred Stock shall be entitled to receive a cash payment in the amount of $0.01 per share of Class A Preferred Stock prior to such pro rata distribution.
Section 6. Conversion.
(a) Conversion at the Option of the Holders. Subject to the provisions of this Section 6, each Holder shall have the right, at any time and from time to time, to convert each share of Class A Preferred Stock held by such Holder into a number of validly issued, fully paid and non-assessable shares of Common Stock equal to the Conversion Ratio; provided that, no Holder shall have the right to exercise such conversion right until the later of (i) if applicable, the expiration or termination of the applicable waiting period (and any extension thereof) under the HSR Act, and (ii) the effectiveness of the Authorized Increase Amendment.
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(b) Automatic Conversion Upon Change of Control. Upon a Change of Control, each outstanding share of Class A Preferred Stock shall automatically convert into a number of validly issued, fully paid and non-assessable shares of Common Stock immediately prior to the consummation of such Change of Control equal to the Conversion Ratio; provided that no such conversion shall occur until, if applicable, the expiration or termination of the applicable waiting period (and any extension thereof) under the HSR Act; provided, further, that upon a Change of Control of a type described in clauses (a), (b) or (c) of the definition thereof, if no automatic conversion is permitted pursuant to the previous proviso, then all Holders shall receive, in connection with such Change of Control, in exchange for their shares of Class A Preferred Stock the same amount of cash, securities and/or other assets as they would have received if their shares of Class A Preferred Stock had been automatically converted into Common Stock pursuant to the terms of this Certificate of Designation immediately prior to such Change of Control, without regard to any limitations on conversion set forth herein or otherwise and without regard as to whether sufficient shares of Common Stock are available out of the Corporation’s authorized but unissued stock for the purpose of effecting the conversion of the Class A Preferred Stock. For the avoidance of doubt, beneficial ownership resulting solely from the acquisition, holding or conversion of Class A Preferred Stock in accordance with the terms hereof shall not, by itself, constitute a Change of Control.
(c) Conversions Upon Qualified Sale. Subject to the provisions of this Section 6, each share of Class A Preferred Stock shall automatically convert immediately prior to the closing of a Qualified Sale of such share into a number of validly issued, fully paid and non-assessable shares of Common Stock equal to the Conversion Ratio without any further action on the part of the Corporation or the Holder.
(d) Mechanics of Conversion.
(i) Delivery of Shares Upon Conversion. As soon as practicable on or after each Conversion Date, but in any event within two (2) Business Days thereof, the Corporation shall deliver, or cause to be delivered, to the Holder, in the case of a conversion pursuant to subsections (a) or (b), or to the purchaser in the Qualified Sale, in the case of a conversion pursuant to subsection (c), a book-entry notation which will contain or be deemed to contain appropriate restrictive legends and trading restrictions, as applicable, representing the number of Conversion Shares issuable upon conversion. The Corporation shall use its best efforts to deliver any book-entry notation required to be delivered by the Corporation under this Section 6 electronically through the Depository Trust Company (including the DWAC system) or another established clearing corporation performing similar functions. If any shares of Common Stock are to be issued upon conversion of Class A Preferred Stock pursuant to subsection (c), above, the converting Holder may specify that the applicable Conversion Shares be delivered to the purchaser in the relevant Qualified Sale in lieu of delivery to such converting Holder. The “Conversion Date” means: (a) with respect to a conversion pursuant to Section 6(a), the date on which a Holder delivers to the Corporation written notice of conversion; (b) with respect to a conversion pursuant to Section 6(b), the date of the consummation of a Change of Control; or (c) with respect to a conversion pursuant to Section 6(c), the date on which a Holder delivers to the Corporation sale documentation of a Qualified Sale.
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(ii) Reservation of Shares Issuable Upon Conversion. Upon the filing of the Authorized Increase Amendment with the Secretary of State of the State of Delaware, the Corporation covenants that it will at all times reserve and keep available out of its authorized and unissued shares of Common Stock for the sole purpose of issuance upon conversion of the Class A Preferred Stock, free from preemptive rights or any other actual or contingent purchase rights of Persons other than the Holders of the Class A Preferred Stock, not less than such aggregate number of shares of the Common Stock as shall be issuable (taking into account the adjustments of Section 7) at any time upon the conversion of all outstanding shares of Class A Preferred Stock. Any shares of Common Stock issued upon conversion of Class A Preferred Stock shall be duly authorized, validly issued, fully paid and non-assessable.
(iii) Fractional Shares. No fractional shares or scrip representing fractional shares of Common Stock shall be issued upon the conversion of the Class A Preferred Stock. Instead, the Corporation shall at its election, either pay a cash adjustment to the Holder based upon the Last Reported Sale Price on the Trading Day immediately prior to the Conversion Date or round up to the next whole share.
(iv) Transfer Taxes. The issuance of book-entry notations for Conversion Shares shall be made without charge to any Holder for any documentary stamp or similar taxes that may be payable in respect of the issue or delivery of such book-entry notation, provided that the Corporation shall not be required to pay any tax that may be payable in respect of any transfer involved in the issuance and delivery of any such book-entry notation upon conversion in a name other than that of the registered Holder(s) of such shares of Class A Preferred Stock and the Corporation shall not be required to issue or deliver such book-entry notation unless or until the Person or Persons requesting the issuance thereof shall have paid to the Corporation the amount of such tax or shall have established to the satisfaction of the Corporation that such tax has been paid.
(e) Status as Stockholder. Subject to the penultimate sentence of Section 6(d)(i), upon each Conversion Date in which shares of the Class A Preferred Stock convert into Common Stock: (i) the shares of Class A Preferred Stock being converted shall be deemed converted into shares of Common Stock; and (ii) the Holder’s rights as a holder of such converted shares of Class A Preferred Stock shall cease and terminate, other than the right of the Holder to receive shares of Common Stock and payment in lieu of any fraction of a share issuable upon conversion of a share of Class A Preferred Stock. The Person or Persons entitled to receive the shares of Common Stock issuable upon a conversion of Class A Preferred Stock shall be treated for all purposes as the record holder or holders of such shares of Common Stock on the Conversion Date.
Section 7. Certain Adjustments.
(a) Stock Dividends and Stock Splits. If the Corporation, at any time while the Class A Preferred Stock is outstanding: (i) pays a stock dividend or otherwise makes a distribution or distributions payable in shares of Common Stock on shares of Common Stock or any other Common Stock Equivalents (other than any rights offering), (ii) subdivides outstanding shares of Common Stock into a larger number of shares, or (iii) combines (including by way of a reverse stock split) outstanding shares of Common Stock into a smaller number of shares, then the Conversion Ratio shall be multiplied by a fraction of which the numerator will be the number of shares of Common Stock (excluding any treasury shares of the Corporation) outstanding
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immediately after such event and of which the denominator will be the number of shares of Common Stock outstanding immediately before such event. Any adjustment made pursuant to this Section 7(a) will become effective immediately after the date fixed for the determination of stockholders entitled to receive such dividend or distribution and will become effective immediately after the effective date in the case of a subdivision or combination.
(b) Reclassification, Exchange or Substitution. If the Common Stock issuable upon the conversion of the Class A Preferred Stock shall be changed into the same or a different number of shares of any class or classes of stock, whether by capital reorganization, reclassification, or otherwise (other than a subdivision or combination of shares or stock dividend provided for above, or a reorganization, merger, consolidation, or sale of assets provided for below and other than a Change of Control transaction or Deemed Liquidation Event with respect to which Section 5 shall apply), then and in each such event the holder of each such share of Class A Preferred Stock shall have the right thereafter to convert such share into the kind and amount of shares of stock and other securities and property receivable, upon such reorganization, reclassification, or other change, by holders of the number of shares of Common Stock into which such shares of Class A Preferred Stock might have been converted immediately prior to such reorganization, reclassification, or change, all subject to further adjustment as provided herein.
(c) Merger or Reorganization, etc. If there shall occur any reorganization, recapitalization, reclassification, consolidation or merger involving the Corporation in which the Common Stock (but not the Class A Preferred Stock) is converted into or exchanged for securities, cash or other property (other than a transaction covered by paragraphs (a) or (b) of this Section 7), then, following any such reorganization, recapitalization, reclassification, consolidation or merger, each share of Class A Preferred Stock shall be convertible into the kind and amount of securities, cash or other property which a holder of the number of shares of Common Stock of the Corporation issuable upon conversion of one share of Class A Preferred Stock immediately prior to such reorganization, recapitalization, reclassification, consolidation or merger would have been entitled to receive pursuant to such transaction and, in such case, appropriate adjustment (as determined in good faith by the Board) shall be made in the application of the provisions in this Section 7 with respect to the rights and interests thereafter of the holders of the Class A Preferred Stock to the end that the provisions set forth in this Section 7 (including provisions with respect to changes in and other adjustments of the Conversion Ratio, as applicable) shall thereafter be applicable, as nearly as reasonably may be, in relation to any securities or other property thereafter deliverable upon the conversion of the Class A Preferred Stock. In the event that holders of Common Stock have the opportunity to elect the form of consideration to be received in such a transaction, the Corporation shall ensure that the Holders of the Class A Preferred Stock have the same opportunity to elect the form of consideration, in accordance with the same procedures and proration mechanics that apply to the election made by holders of Common Stock.
(d) Calculations. All calculations under this Section 7 shall be made to the nearest cent or the nearest 1/10,000th of a share, as the case may be. For purposes of this Section 7, the number of shares of Common Stock deemed to be issued and outstanding as of a given date shall be the number of shares of Common Stock (excluding any treasury shares of the Corporation) issued and outstanding.
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(e) Notice to the Holders. Whenever the Conversion Ratio is adjusted pursuant to any provision of this Section 7, the Corporation shall promptly deliver to each Holder a notice setting forth the Conversion Ratio after such adjustment and setting forth a brief statement of the facts requiring such adjustment.
Section 8. Redemption. To the extent that the Authorized Increase Amendment has not become effective within eighteen (18) months of the Initial Issue Date (the “Amendment Deadline”), the Corporation shall redeem the Class A Preferred Stock for cash at a redemption price per share of Class A Preferred Stock equal to the product of (x) the Conversion Ratio then in effect and (y) the arithmetic average of the VWAP per share of Common Stock for each Trading Day over the five consecutive Trading Day period ending on, and including, the Amendment Deadline. The redemption price shall be payable on or prior to the fifth (5th) Business Day following the Amendment Deadline. Other than as set forth in this Section 8, the Series A Preferred Stock shall not be redeemable.
Section 9. Miscellaneous.
(a) Waiver. Any waiver by the Corporation or a Holder of a breach of any provision of this Certificate of Designation shall not operate as or be construed to be a waiver of any other breach of such provision or of any breach of any other provision of this Certificate of Designation or a waiver by any other Holders. The failure of the Corporation or a Holder to insist upon strict adherence to any term of this Certificate of Designation on one or more occasions shall not be considered a waiver or deprive that party (or any other Holder) of the right thereafter to insist upon strict adherence to that term or any other term of this Certificate of Designation. Any waiver by the Corporation or a Holder must be in writing. Notwithstanding any provision in this Certificate of Designation to the contrary, any provision contained herein and any right of the Holders of Class A Preferred Stock granted hereunder may be waived as to all shares of Class A Preferred Stock (and the Holders thereof) upon the written consent of a majority of shares of Class A Preferred Stock, unless a higher percentage is required by the DGCL, in which case the written consent of the Holders of not less than such higher percentage shall be required, or unless the consent or vote of another class of capital stock is required by the DGCL, in which case the consent of such other class shall also be required.
(b) Severability. If any provision of this Certificate of Designation is invalid, illegal or unenforceable, the balance of this Certificate of Designation shall remain in effect, and if any provision is inapplicable to any Person or circumstance, it shall nevertheless remain applicable to all other Persons and circumstances. If it shall be found that any interest or other amount deemed interest due hereunder violates the applicable law governing usury, the applicable rate of interest due hereunder shall automatically be lowered to equal the maximum rate of interest permitted under applicable law.
(c) Next Business Day. Whenever any payment or other obligation hereunder shall be due on a day other than a Business Day, such payment shall be made on the next succeeding Business Day.
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(d) Headings. The headings contained herein are for convenience only, do not constitute a part of this Certificate of Designation and shall not be deemed to limit or affect any of the provisions hereof.
(e) Status of Converted Class A Preferred Stock. If any shares of Class A Preferred Stock shall be converted into shares of Common Stock pursuant to Section 6 hereof, the Board shall take such action as is required such that such converted shares shall resume the status of authorized but unissued shares of Preferred Stock of the Corporation and shall no longer be designated as Class A Preferred Stock.
* * * * *
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IN WITNESS WHEREOF, Summit Therapeutics Inc. has caused this Certificate of Designation of Preferences, Rights and Limitations of Class A Convertible Preferred Stock to be executed by its duly authorized officer this 28th day of September, 2026.
| SUMMIT THERAPEUTICS INC. | ||
| By: | /s/ Mahkam Zanganeh | |
| Name: | Dr. Mahkam Zanganeh | |
| Its: | Co-Chief Executive Officer and President | |
SIGNATURE PAGE TO CERTIFICATE OF DESIGNATION
Exhibit 10.1
SECURITIES PURCHASE AGREEMENT
This SECURITIES PURCHASE AGREEMENT (this “Agreement”) is dated as of September 28, 2026, by and between Summit Therapeutics Inc., a Delaware corporation (the “Company”), and AstraZeneca Holdings B.V., a Dutch private limited liability company (the “Investor”).
WHEREAS, the Company and the Investor are executing and delivering this Agreement in reliance upon the exemption from securities registration afforded by Section 4(a)(2) and/or Rule 506 of Regulation D promulgated thereunder of the U.S. Securities Act of 1933 (the “Securities Act”);
WHEREAS, the Company desires to sell to the Investor, and the Investor desires to purchase from the Company, upon the terms and subject to the conditions stated in this Agreement, shares (the “Shares”) of the Convertible Preferred Stock; and
WHEREAS, contemporaneously with the sale of the Shares, the parties hereto will execute and deliver a Registration Rights Agreement, substantially in the form attached hereto as Exhibit A, pursuant to which the Company will agree to provide certain registration rights in respect of the Underlying Shares under the Securities Act and applicable state securities laws.
NOW THEREFORE, in consideration of the mutual agreements, representations, warranties and covenants herein contained, the Company and the Investor agree as follows:
1. Definitions. As used in this Agreement, the following terms shall have the following respective meanings:
1.1 Defined Terms. As used in this Agreement, the following terms shall have the following respective meanings:
“2026 SEC Reports” means (a) the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and (b) any Quarterly Reports on Form 10-Q or any Current Reports on Form 8-K filed or furnished (as applicable) by the Company after December 31, 2025 and prior to the Business Day immediately preceding the date hereof, together in each case with any documents incorporated by reference therein or exhibits thereto.
“Acquisition Proposal” means a bona fide offer, indication of interest or proposal received by the Company from a third party in respect of an Acquisition Transaction, in each case in writing and that includes at least high-level financial terms of such Acquisition Transaction.
“Acquisition Transaction” means a transaction or series of related transactions, whether by merger, consolidation, reorganization, plan of exchange, sale or license of assets, or transfer or sale of securities (including a tender offer or exchange offer) or otherwise, that, if consummated, would result in a third party (or the stockholders of a third party) succeeding to, licensing or acquiring, directly or indirectly, or obtaining the right to license or acquire, directly or indirectly, all or substantially all of the outstanding equity securities of the Company or all or substantially all of the consolidated assets of the Company.
“Affiliate” means, with respect to any Person, any other Person that, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with such Person.
“Amended and Restated Bylaws” means the Bylaws of the Company, as currently in effect.
“Amended and Restated Certificate of Incorporation” means the Certificate of Incorporation of the Company, as currently in effect.
“Benefit Plan” or “Benefit Plans” means employee benefit plans as defined in Section 3(3) of ERISA and all other employee benefit practices or arrangements, including, without limitation, any such practices or arrangements providing severance pay, sick leave, vacation pay, salary continuation for disability, retirement benefits, deferred compensation, bonus pay, incentive pay, stock options or other stock-based compensation, hospitalization insurance, medical insurance, life insurance, scholarships or tuition reimbursements, maintained by the Company or to which the Company or any of its Significant Subsidiaries is obligated to contribute for employees or former employees of the Company and its Significant Subsidiaries.
“Board of Directors” means the board of directors of the Company.
“Business Day” means any day except any Saturday, any Sunday, any day which is a federal legal holiday in the United States or any day on which banking institutions in the State of New York, Amsterdam, the Netherlands or London, United Kingdom are authorized or required by law or other governmental action to close.
“Certificate of Designations” means the Certificate of Designations of the Convertible Preferred Stock, substantially in the form attached hereto as Exhibit B.
“Code” means the U.S. Internal Revenue Code of 1986, as amended.
“Common Stock” means the common stock, par value $0.01 per share, of the Company.
“Common Stock Equivalents” means any securities of the Company that would entitle the holder thereof to acquire at any time Common Stock, including, without limitation, any debt, preferred stock, rights, options, warrants or other instrument that is at any time convertible into or exchangeable for, or otherwise entitles the holder thereof to receive, Common Stock.
“Convertible Preferred Stock” means the Class A Convertible Preferred Stock, par value $0.01 per share, of the Company, the terms of which will be set forth in the Certificate of Designations.
“Drug Regulatory Agency” means the U.S. Food and Drug Administration (“FDA”) or other foreign, state, local or comparable governmental authority responsible for regulation of the research, development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of drug or biological products and drug or biological product candidates.
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“EDGAR” means the SEC’s Electronic Data Gathering, Analysis and Retrieval System.
“ERISA” means the U.S. Employee Retirement Income Security Act of 1974, as amended.
“Exchange Act” means the U.S. Securities Exchange Act of 1934, as amended, and all of the rules and regulations promulgated thereunder.
“HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.
“Knowledge” means, with respect to any matter in question, the knowledge of the Company’s executive officers after making due inquiry of the other employees having primary responsibility for such matter.
“Material Adverse Effect” means any change, event, circumstance, development, condition, occurrence or effect that, individually or in the aggregate, (a) was, is, or would reasonably be expected to be, materially adverse to the business, financial condition, properties, assets, liabilities, stockholders’ equity or results of operations of the Company and its Significant Subsidiaries, taken as a whole, or (b) materially delays or materially impairs the ability of the Company to comply, or prevents the Company from complying, with its obligations under this Agreement, the other Transaction Agreements, or with respect to the Closing or would reasonably be expected to do so; provided, however, that none of the following will be deemed in themselves, either alone or in combination, to constitute, and that none of the following will be taken into account in determining whether there has been or will be, a Material Adverse Effect under subclause (a) of this definition:
(i) any change generally affecting the economy, financial markets or political, economic or regulatory conditions in the United States or any other geographic region in which the Company conducts business, provided that the Company is not disproportionately affected thereby;
(ii) general financial, credit or capital market conditions, including interest rates or exchange rates, or any changes therein, provided that the Company is not disproportionately affected thereby;
(iii) any change that generally affects industries in which the Company and its Significant Subsidiaries conduct business, provided that the Company is not disproportionately affected thereby;
(iv) earthquakes, hurricanes, tsunamis, tornadoes, floods, mudslides, fires or other natural disasters, weather conditions, global pandemics, including the COVID-19 pandemic and related strains, epidemic or similar health emergency, and other force majeure events in the United States or any other location, provided that the Company is not disproportionately affected thereby;
(v) national or international political or social conditions (or changes in such conditions), whether or not pursuant to the declaration of a national emergency or war, or the occurrence of any military or terrorist attack, provided that the Company is not disproportionately affected thereby;
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(vi) material changes in laws after the date of this Agreement; and
(vii) in and of itself, any material failure by the Company to meet any published or internally prepared estimates of revenues, expenses, earnings or other economic performance for any period ending on or after the date of this Agreement (it being understood that the facts and circumstances giving rise to such failure may be deemed to constitute, and may be taken into account in determining whether there has been, a Material Adverse Effect to the extent that such facts and circumstances are not otherwise described in clauses (i)-(v) of this definition).
“Material Contract” means any of the following contracts of the Company or any of its Significant Subsidiaries that are currently in effect:
(i) any “material contract” (as defined in Item 601(b)(10) of Regulation S-K promulgated by the SEC, other than those agreements and arrangements described in Item 601(b)(10)(iii) of Regulation S-K) with respect to the Company and its Significant Subsidiaries, taken as a whole;
(ii) any contract under which the Company or any of its Significant Subsidiaries has (A) been granted a license or other right or interest in, to or under any third Person’s intellectual property that is material to the Company or the operation of its business, or (B) granted (1) an exclusive license or other exclusive rights or exclusive interests in the Intellectual Property of ivonescimab, or (2) any non-exclusive license, covenant not to sue or other right, immunity or forbearance in the Intellectual Property of ivonescimab permitting any Third Party to commercialize ivonescimab (other than to a distributor in the ordinary course of business), in each case that is material to the Company or the operation of its business; and
(iii) any contract between the Company or any of its Significant Subsidiaries, on the one hand, and any director, officer or employee of the Company or any of its Significant Subsidiaries or any Person that, to the Company’s Knowledge, beneficially owns (within the meaning of Rule 13d-3 under the Exchange Act) five percent (5%) or more of the outstanding shares of Common Stock or of the outstanding shares of common stock of any of the Company’s Significant Subsidiaries, on the other hand, in each case of a type that would be required to be disclosed under Item 404 of Regulation S-K under the Securities Act.
“Nasdaq” means the Nasdaq Stock Market LLC.
“National Exchange” means any of the following markets or exchanges on which the Common Stock is listed or quoted for trading on the date in question, together with any successor thereto: the NYSE American, The New York Stock Exchange, the Nasdaq Global Market, the Nasdaq Global Select Market and the Nasdaq Capital Market.
“Offering Notice” means a notice from the Company to the Investor of an anticipated underwritten public offering or other public offering for which a Preemptive Offer Notice is not being sent prior to the issuance of the securities pursuant to Section 5.15(d).
“Per Share Price” means $18,356.14.
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“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.
“Regulatory Approvals” means (a) the expiration or termination of any applicable waiting period under the HSR Act and (b) any other consent, approval, clearance or authorization of, or expiration or termination of any waiting period imposed by, any Governmental Entity under any other antitrust, competition, merger control or foreign investment law that the Company and the Investor determine pursuant to Section 5.12 is required by applicable law to be obtained or to have occurred prior to the consummation of the transactions contemplated by this Agreement.
“Rule 144” means Rule 144 promulgated by the SEC pursuant to the Securities Act, as such Rule may be amended from time to time, or any similar rule or regulation hereafter adopted by the SEC having substantially the same effect as such Rule.
“SEC” means the U.S. Securities and Exchange Commission.
“Short Sales” include, without limitation, (a) all “short sales” as defined in Rule 200 promulgated under Regulation SHO under the Exchange Act, whether or not against the box, and all types of direct and indirect stock pledges, forward sale contracts, options, puts, calls, short sales, swaps, “put equivalent positions” (as defined in Rule 16a-1(h) under the Exchange Act) and similar arrangements (including on a total return basis), and (b) sales and other transactions through non-U.S. broker dealers or non-U.S. regulated brokers (but shall not be deemed to include the location and/or reservation of borrowable shares of Common Stock).
“Tax” or “Taxes” means any and all federal, state, local, foreign and other taxes, levies, fees, imposts, duties and charges of whatever kind (including any interest, penalties or additions to the tax imposed in connection therewith or with respect thereto), whether or not imposed on the Company, including, without limitation, taxes imposed on, or measured by, income, franchise, profits or gross receipts, and also ad valorem, value added, sales, use, service, real or personal property, capital stock, license, payroll, withholding, employment, social security, workers’ compensation, unemployment compensation, utility, severance, production, excise, stamp, occupation, premium, windfall profits, transfer and gains taxes and customs duties.
“Tax Returns” means returns, reports, information statements and other documentation (including any additional or supporting material) filed or maintained, or required to be filed or maintained, in connection with the calculation, determination, assessment or collection of any Tax and shall include any amended returns required as a result of examination adjustments made by the Internal Revenue Service or other Tax authority.
“Transaction Agreements” means this Agreement and the Registration Rights Agreement.
“Transfer Agent” means Computershare Trust Company, N.A., or such other financial institution that provides transfer agent services as the Company may engage from time to time.
“Underlying Shares” means the shares of Common Stock issuable on conversion of the Shares in accordance with the Certificate of Designations.
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1.2 Cross-References. Each of the following terms is defined in the Section set forth opposite such term:
| Term | Section | |
| Active Bid Notice |
5.16(a) | |
| Aggregate Purchase Amount |
2.1 | |
| Agreement |
Preamble | |
| Authorized Increase Amendment |
5.19(b) | |
| Closing |
2.2 | |
| Closing Date |
2.2 | |
| Company |
Preamble | |
| Confidential Data |
3.33 | |
| DGCL |
8.4 | |
| Disclosure Documents |
5.3(a) | |
| Disqualification Event |
3.22 | |
| Election Period |
5.15(b) | |
| Environmental Laws |
3.15 | |
| EU |
3.21 | |
| Financial Statements |
3.8(b) | |
| Fraud |
8.20 | |
| GAAP |
3.8(b) | |
| Governmental Authorizations |
3.11 | |
| Governmental Entity |
3.11 | |
| Health Care Laws |
3.21 | |
| HIPAA |
3.33 | |
| Intellectual Property |
3.12 | |
| Investor |
Preamble | |
| Investor Offer |
5.16(b) | |
| Issuance |
5.15(d) | |
| Issuer Covered Person |
3.22 | |
| Issuer Covered Persons |
3.22 | |
| IT Systems |
3.33 | |
| Lock-Up Period |
5.17(a) | |
| Non-Party Affiliate |
8.20 | |
| Notice of Acceptance |
5.15(c) | |
| Notification Date |
5.12(a) | |
| Personal Data |
3.33 | |
| Preemptive Offer Notice |
5.15(b) | |
| Preemptive Right |
5.15(a) | |
| Privacy Laws |
3.34 | |
| Privacy Statements |
3.34 | |
| Processing |
3.34 | |
| Proportionate Percentage |
5.15(a) | |
| Registration Rights Agreement |
6.1(i) | |
| Regulatory Agencies |
3.20 | |
| Rule 506(d) Related Party |
4.14 | |
| SEC Reports |
3.8(a) | |
| Securities Act |
Recitals | |
| Shares |
Recitals | |
| Significant Subsidiaries |
3.1 |
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2. Purchase and Sale of Securities.
2.1 Purchase and Sale. On the Closing Date, upon the terms and subject to the conditions set forth herein, the Company agrees to issue and sell to the Investor, and the Investor agrees to acquire and purchase from the Company, a number of Shares (rounded to four decimal places) equal to (x) $2,000,000,000 divided by (y) the Per Share Price, for an aggregate purchase price of $2,000,000,000 (the “Aggregate Purchase Amount”).
2.2 Closing. Subject to the satisfaction or waiver of the conditions set forth in Section 6 of this Agreement, the closing of the purchase and sale of the Shares (the “Closing” and the date on which the Closing occurs, the “Closing Date”) shall occur remotely via the exchange of documents and signatures at such time as shall be determined by the Investor at its discretion, but in no event later than the fifth (5th) Business Day after the date hereof, subject to the satisfaction or waiver of the conditions set forth in Section 6. A condition set forth in Section 6 may only be waived in writing by the party entitled to the benefit of such condition. At the Closing, the Company shall issue and sell to the Investor, and the Investor shall acquire and purchase from the Company, against payment by the Investor to the Company of the Aggregate Purchase Amount, by wire transfer of immediately available funds at or prior to the Closing, in accordance with wire instructions provided by the Company to the Investor prior to the date hereof, the Shares. The Company shall issue the Shares to the Investor in book-entry form, free and clear of all restrictive and other legends (except as expressly provided in Section 4.10 hereof) and the Company shall provide evidence of such issuance as of the Closing Date to the Investor. In the event that the Closing has not occurred within one Business Day after the expected Closing Date, unless otherwise agreed by the Company and the Investor, the Company shall promptly (but no later than one Business Day thereafter) return the previously wired Aggregate Purchase Amount to the Investor by wire transfer of United States dollars in immediately available funds to the account specified by the Investor, and any book entries for the Shares shall be deemed cancelled; provided that, unless this Agreement has been terminated pursuant to Section 7, such return of funds shall not terminate this Agreement or relieve such Investor of its obligation to purchase, or the Company of its obligation to issue and sell, the Shares at the Closing.
2.3 Adjustments. Without limiting or affecting any of the provisions of Section 5.13, if between the execution of this Agreement and the Closing the outstanding shares of Common Stock shall have been changed into a different number of shares or a different class by reason of the occurrence of any stock split, reverse stock split, stock dividend (including any dividend or other distribution of securities convertible into Common Stock), reorganization, recapitalization, reclassification, combination, exchange of shares or other like change, the Per Share Price and number of Shares to be issued to this Section 2 shall be appropriately adjusted to reflect such stock split, reverse stock split, stock dividend (including any dividend or other distribution of securities convertible into Common Stock), reorganization, recapitalization, reclassification, combination, exchange of shares or other like change.
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3. Representations and Warranties of the Company. The Company hereby represents and warrants to the Investor that the statements contained in this Section 3 are true and correct as of the date hereof and as of the Closing Date (except for the representations and warranties that speak as of a specific date, which shall be made as of such date):
3.1 Organization and Power. The Company 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 2026 SEC Reports 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, except where such failure to be in good standing or to have such power and authority or to so qualify would not reasonably be expected to have a Material Adverse Effect. As of the date hereof, the Company has the significant subsidiaries (as that term is defined in Rule 1-02 of Regulation S-X of the Exchange Act) listed in Exhibit 21 to the Company’s most recent Annual Report on Form 10-K (collectively, the “Significant Subsidiaries”). Each of the Significant Subsidiaries is duly incorporated and validly existing and in good standing under the laws of the jurisdiction of its incorporation and has the requisite power and authority to carry on their business as now conducted and to own or lease its properties. Each of the Significant Subsidiaries is duly qualified to do business as a foreign corporation and is in good standing in each jurisdiction in which such qualification is required unless the failure to so qualify has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
3.2 Capitalization. The authorized capital stock of the Company consists of 1,000,000,000 shares of Common Stock and 20,000,000 shares of preferred stock, par value $0.01 per share. The Company’s disclosure of its issued and outstanding capital stock in the 2026 SEC Reports containing such disclosure was accurate in all material respects as of the date indicated in such 2026 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 Company were issued in violation of any preemptive or other similar rights of any securityholder of the Company 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. As of the Closing Date, the Company will have a sufficient number of authorized and unissued shares of Convertible Preferred Stock to issue the Shares at the Closing.
3.3 Registration Rights. Except as set forth in the Transaction Agreements or as disclosed in the 2026 SEC Reports, the Company is presently not under any obligation, and has not granted any rights, to register under the Securities Act any of the Company’s presently outstanding securities or any of its securities that may hereafter be issued that have not expired or been satisfied or waived.
3.4 Authorization. The Company has all requisite corporate power and authority to enter into the Transaction Agreements and to carry out and perform its obligations under the terms of the Transaction Agreements, including the issuance and sale of the Shares and the reservation and issuance of the Underlying Shares, other than the approval of the Authorized Increase Amendment. Other than the approval of the Authorized Increase Amendment by the Company’s stockholders, all corporate action on the part of the Company, its officers, directors and stockholders necessary for the authorization of the Shares, the authorization, execution,
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delivery and performance of the Transaction Agreements and the consummation of the transactions contemplated herein, including the issuance and sale of the Shares and the reservation and issuance of the Underlying Shares, has been taken. This Agreement has been duly executed and delivered by the Company and assuming the due authorization, execution and delivery by the Investor and that this Agreement constitutes the legal, valid and binding agreement of the Investor, this Agreement constitutes a legal, valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, except as such enforceability may be limited by bankruptcy, insolvency, reorganization, moratorium and similar laws relating to or affecting creditors generally or by general equity principles (regardless of whether such enforceability is considered in a proceeding in equity or at law). Upon its execution by the Company and the other parties thereto and assuming that it constitutes legal, valid and binding agreements of the other parties thereto, the Registration Rights Agreement will constitute a legal, valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, except as such enforceability may be limited by bankruptcy, insolvency, reorganization, moratorium and similar laws relating to or affecting creditors generally or by general equity principles (regardless of whether such enforceability is considered in a proceeding in equity or at law).
3.5 Valid Issuance. The Shares being purchased by the Investor hereunder have been duly and validly authorized and, upon issuance pursuant to the terms hereof, against full payment therefor in accordance with the terms of this Agreement, will be duly and validly issued, fully paid and non-assessable and will be issued free and clear of any liens or other restrictions (other than those as provided in the Transaction Agreements, the Certificate of Designations or restrictions on transfer under applicable state and federal securities laws) and the holder of the Shares shall be entitled to all rights accorded to a holder of Convertible Preferred Stock set forth in the Certificate of Designations. Following the filing of the Authorized Increase Amendment with the Secretary of State of the State of Delaware, and on issuance in accordance with the Certificate of Designations, the Underlying Shares will be duly and validly issued, fully paid and non-assessable and will be free and clear of any liens or other restrictions (other than those as provided in this Transaction Agreement or restrictions on transfer under applicable state and federal securities laws) and the holder of the Underlying Shares shall be entitled to all rights accorded to a holder of Common Stock. Subject to the accuracy of the representations and warranties made by the Investor in Section 4 hereof, the offer and sale of the Shares and the issuance of the Underlying Shares to the Investor is and will be in compliance with applicable exemptions from (i) the registration and prospectus delivery requirements of the Securities Act and (ii) the registration and qualification requirements of applicable securities laws of the states of the United States.
3.6 No Conflict. The execution, delivery and performance of the Transaction Agreements by the Company, the issuance and sale of the Shares and the consummation of the other transactions contemplated by the Transaction Agreements will not (i) violate any provision of the Amended and Restated Certificate of Incorporation (other than conversion of Shares into the Underlying Shares prior to the effectiveness of the Authorized Increase Amendment) or Amended and Restated Bylaws of the Company, (ii) conflict with or result in a violation of or default (with or without notice or lapse of time, or both) under, or give rise to a right of termination, cancellation or acceleration of any obligation, a change of control right or to a loss of a benefit under any agreement or instrument, credit facility, franchise, license, judgment, order, statute, law, ordinance, rule or regulations, applicable to the Company or any Significant Subsidiary or their
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respective properties or assets, or (iii) result in a violation of any law, rule, regulation, order, judgment, injunction, decree or other restriction of any court or governmental authority to which the Company or any Significant Subsidiary is subject (including federal and state securities laws and regulations) and the rules and regulations of any self-regulatory organization to which the Company or its securities are subject, or by which any property or asset of the Company or any Significant Subsidiary is bound or affected, except, in the case of clauses (ii) and (iii), as would not, individually or in the aggregate, be reasonably expected to have a Material Adverse Effect.
3.7 Consents. Assuming the accuracy of the representations and warranties of the Investor, 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 Company of the Transaction Agreements, the issuance and sale of the Shares and the Underlying Shares and the performance by the Company of its other obligations under the Transaction Agreements, except such as (a) have been or will be obtained or made under the Securities Act or the Exchange Act, (b) the filing of any requisite notices and/or application(s) to the National Exchange for the issuance and sale of the Underlying Shares for trading or quotation, as the case may be, thereon in the time and manner required thereby, (c) customary post-closing filings with the SEC or pursuant to state securities laws in connection with the offer and sale of the Shares and the Underlying Shares by the Company in the manner contemplated herein, which will be filed on a timely basis, (d) the filing of the registration statement required to be filed by the Registration Rights Agreement, (e) the stockholder approval of the Authorized Increase Amendment and the filing of the Authorized Increase Amendment with the Secretary of State of the State of Delaware, (f) the filing of the Certificate of Designations with the Secretary of State of the State of Delaware or (g) such that the failure of which to obtain would not have a Material Adverse Effect. Other than with regards to the Authorized Increase Amendment, all notices, consents, authorizations, orders, filings and registrations which the Company 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.
3.8 SEC Filings; Financial Statements.
(a) The Company has timely filed or furnished, as applicable, all forms, statements, certifications, reports and documents required to be filed or furnished by it with the SEC under the Exchange Act or the Securities Act for the one year preceding the date hereof (the “SEC Reports”). As of the time it was filed with, or furnished to, 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 SEC Reports complied in all material respects with the applicable requirements of the Securities Act or the Exchange Act (as the case may be), and the rules and regulations promulgated thereunder, and, as of the time they were filed or furnished, none of the 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. None of the SEC Reports is the subject of an ongoing SEC review.
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(b) The financial statements of the Company included in the SEC Reports (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 financial position of the Company as of the dates indicated, and the results of its operations and cash flows for the periods therein specified, all in accordance with United States generally accepted accounting principles (“GAAP”) (except as otherwise noted therein, and in the case of unaudited financial statements, as permitted by Form 10-Q of the SEC, and except that the unaudited financial statements may not contain footnotes and are subject to normal and recurring year-end adjustments) applied on a consistent basis unless otherwise noted therein throughout the periods therein specified. Except as set forth in the Financial Statements filed prior to the date hereof, the Company 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.
3.9 Absence of Changes. Except as otherwise stated or disclosed in the 2026 SEC Reports, between June 30, 2026 and the date of this Agreement, (a) the Company has conducted its business only in the ordinary course of business and there have been no material transactions entered into by the Company (except for the execution and performance of this Agreement and the discussions, negotiations and transactions related thereto); (b) there has been no material change to any material contract or arrangement covered by clause (i) of the definition of “Material Contract” set forth in Section 1.1 hereof, and by which the Company is bound or to which any of its assets or properties is subject has been entered into that has not been disclosed in the 2026 SEC Reports; and (c) there has not been any other event or condition of any character that has had or would reasonably be expected to have a Material Adverse Effect.
3.10 Absence of Litigation. There is no action, suit, proceeding, arbitration, claim, investigation, charge, complaint or inquiry pending or, to the Company’s Knowledge, threatened against the Company or any Significant Subsidiary 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 Company or any Significant Subsidiary that have had or would reasonably be expected to have a Material Adverse Effect. Other than as disclosed in the 2026 SEC Reports, neither the Company nor any Significant Subsidiary, nor to the Knowledge of the Company, any director or officer of the Company or any Significant Subsidiary, is, or within the last ten years has been, the subject of any action (not withdrawn or dismissed) involving a claim of violation of or liability under federal or state securities laws relating to the Company or such Significant Subsidiary or a claim of breach of fiduciary duty relating to the Company or such Significant Subsidiary.
3.11 Compliance with Law; Permits. None of the Company or any Significant Subsidiary is in violation of, or, to the Company’s Knowledge, 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
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Effect. The Company and its Significant 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 (each, a “Governmental Entity”) that are currently necessary for the operation of the business of the Company and its Significant Subsidiaries as currently conducted, except (a) where the failure to possess currently such Governmental Authorizations has not had and is not reasonably expected to have a Material Adverse Effect or (b) as disclosed to the Investor in writing on or prior to the date hereof. None of the Company or any Significant Subsidiary has received any written (or, to the Company’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.
3.12 Intellectual Property. The Company and its Significant Subsidiaries own, or have rights to use, all material inventions, patent applications, patents, trademarks, trade names, service names, service marks, copyrights, trade secrets, know how (including unpatented and/or unpatentable proprietary or confidential information, systems or procedures) and other intellectual property as described in the 2026 SEC Reports necessary for, or used in the conduct of their respective businesses (including as described in the 2026 SEC Reports) (collectively, “Intellectual Property”), except where any failure to own, possess or acquire such Intellectual Property has not had, and would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. The Intellectual Property of the Company and its Significant Subsidiaries has not been adjudged by a court of competent jurisdiction to be invalid or unenforceable, in whole or in part. To the Company’s Knowledge: (i) there are no third parties who have any liens, security interests, or other encumbrances on any Intellectual Property; and (ii) there is no infringement by third parties of any Intellectual Property. Other than as disclosed in the 2026 SEC Reports, no formal legal proceeding is pending, or, to the Company’s Knowledge, is threatened: (A) challenging the Company’s or its Significant Subsidiaries’ rights in or to any Intellectual Property; (B) challenging the validity, enforceability or scope of any Intellectual Property; or (C) alleging that the Company or any of its Significant Subsidiaries infringes, misappropriates, or otherwise violates any patent, trademark, trade name, service name, copyright, trade secret or other proprietary rights of others, except, in each case, which, individually or in the aggregate, have not had and would not reasonably be expected to have a Material Adverse Effect. The Company and its Significant Subsidiaries have complied in all material respects with the terms of each agreement pursuant to which Intellectual Property has been licensed to the Company or any of its Significant Subsidiaries in all material respects, and to the Company’s Knowledge all such agreements are in full force and effect. To the Company’s Knowledge, there are no material defects in any of the patents or patent applications included in the Intellectual Property. The Company and its Significant Subsidiaries have taken all reasonable steps to protect, maintain and safeguard their Intellectual Property.
3.13 Employee Benefits. Except as would not be reasonably likely to result in a Material Adverse Effect, each Benefit Plan has been established and administered in accordance with its terms and in compliance with the applicable provisions of ERISA, the Code, the Patient Protection and Affordable Care Act of 2010, as amended, and other applicable laws, rules and regulations. The Company and its Significant Subsidiaries are in compliance with all applicable federal, state and local laws, rules and regulations regarding employment, except for any failures
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to comply that are not reasonably likely, individually or in the aggregate, to have a Material Adverse Effect. There is no labor dispute, strike or work stoppage against the Company or its Significant Subsidiaries pending or, to the Knowledge of the Company, threatened which may interfere with the business activities of the Company, except where such dispute, strike or work stoppage is not reasonably likely, individually or in the aggregate, to have a Material Adverse Effect.
3.14 Taxes. The Company and its Significant Subsidiaries have filed all federal, state and foreign income Tax Returns and other Tax Returns required to have been filed under applicable law (or extensions have been duly obtained) and have paid all Taxes required to have been paid by them, except for those which are being contested in good faith and except where failure to file such Tax Returns or pay such Taxes would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. No assessment in connection with United States federal tax returns has been made against the Company. The charges, accruals and reserves on the books of the Company in respect of any income and corporation tax liability for any years not finally determined are adequate to meet any assessments or reassessments for additional income tax for any years not finally determined, except to the extent of any inadequacy that would not result in a Material Adverse Effect. No audits, examinations, or other proceedings with respect to any material amounts of Taxes of the Company and its Significant Subsidiaries are presently in progress or have been asserted or proposed in writing without subsequently being paid, settled or withdrawn. There are no liens on any of the assets of the Company. The Company, at all times since inception, has been and continues to be each classified as a corporation for U.S. federal income tax purposes. Neither the Company nor any of its Significant Subsidiaries has been a United States real property holding corporation within the meaning of Code Section 897I(2) during the period specified in Code Section 897(c)(1)(A)(ii).
3.15 Environmental Laws. The Company and its Significant Subsidiaries (i) are in compliance with any and all applicable foreign, federal, state and local laws and regulations relating to the protection of human health and safety, the environment or hazardous or toxic substances or wastes, pollutants or contaminants (“Environmental Laws”), (ii) have received all permits and other Governmental Authorizations required under applicable Environmental Laws to conduct its business and (iii) are in compliance with all terms and conditions of any such permit, license or approval, except where such noncompliance with Environmental Laws, failure to receive required permits, licenses or other approvals or failure to comply with the terms and conditions of such permits, licenses or approvals would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. None of the Company or any Significant Subsidiary has received since January 1, 2023, any written notice or other communication (in writing or otherwise), whether from a governmental authority or other Person, that alleges that the Company or any Significant Subsidiary is not in compliance with any Environmental Law and, to the Knowledge of the Company, there are no circumstances that may prevent or interfere with the Company’s or any Significant Subsidiary’s compliance in any material respects with any Environmental Law in the future, except where such failure to comply would not reasonably be expected to have a Material Adverse Effect. To the Knowledge of the Company: (i) no current or (during the time a prior property was leased or controlled by the Company) prior property leased or controlled by the Company or any Significant Subsidiary has received since January 1, 2023, any written notice or other communication relating to property owned or leased at any time by the Company, whether from a governmental authority, or other Person, that alleges that such current or prior owner or the Company or any Significant Subsidiary is not in compliance with or violated any Environmental Law relating to such property and (ii) the Company has no material liability under any Environmental Law.
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3.16 Title. Each of the Company and its Significant Subsidiaries has good and marketable title to all personal property owned by it that is material to the business of the Company, free and clear of all liens, encumbrances and defects except such as do not materially affect the value of such property and do not interfere with the use made and proposed to be made of such property by the Company or its Significant Subsidiaries, as the case may be. Any real property and buildings held under lease by the Company or its Significant Subsidiaries is held under valid, subsisting and enforceable leases with such exceptions as are not material and do not interfere with the use made and proposed to be made of such property and buildings by the Company or its Significant Subsidiaries, as the case may be. The Company does not own any real property.
3.17 Insurance. The Company carries or is entitled to the benefits of insurance in such amounts and covering such risks that is customary for comparably situated companies and, in the reasonable judgement of the Company, is adequate for the conduct of its business and the value of its properties (owned or leased) and assets, and each of such insurance policies is in full force and effect and the Company is in compliance in all material respects with the terms thereof. Other than customary end of policy notifications from insurance carriers, since January 1, 2023, the Company has not received any notice or other communication regarding any actual or possible: (i) cancellation or invalidation of any insurance policy or (ii) refusal or denial of any coverage, reservation of rights or rejection of any material claim under any insurance policy.
3.18 Nasdaq Stock Market. The issued and outstanding shares of Common Stock are registered pursuant to Section 12(b) of the Exchange Act and are listed for trading on the Nasdaq Global Market under the symbol “SMMT”. The Company is in compliance in all material respects with all applicable listing requirements of Nasdaq applicable to the Company. As of the date hereof, there is no suit, action, proceeding or investigation pending or, to the Knowledge of the Company, threatened against the Company by Nasdaq or the SEC, respectively, to prohibit or terminate the listing of the Common Stock on the Nasdaq Global Market or to deregister the Common Stock under the Exchange Act. The Company has taken no action as of the date hereof that is designed to terminate the registration of the Common Stock under the Exchange Act.
3.19 Sarbanes-Oxley Act. The Company is, and since January 1, 2023 has been, in compliance with all applicable requirements of the Sarbanes-Oxley Act of 2002 and applicable rules and regulations promulgated by the SEC thereunder.
3.20 Clinical Data and Regulatory Compliance. Except as would not reasonably be expected to result in a Material Adverse Effect: (i) the preclinical tests and clinical trials, and other studies used to support regulatory approval (collectively, “studies”) being conducted by the Company that are described in, or the results of which are referred to in, 2026 SEC Reports were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; (ii) each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its Significant Subsidiaries have no Knowledge of any other studies the results of
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which are inconsistent with, or otherwise call into question, the results described or referred to in the 2026 SEC Reports; (iii) the Company and its Significant Subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA or from any other U.S. federal, state or local government or foreign government or Drug Regulatory Agency, or Institutional Review Board, each having jurisdiction over biopharmaceutical products (collectively, the “Regulatory Agencies”) for the conduct of its business as described in the 2026 SEC Reports; (iv) neither the Company nor any of its Significant Subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination or suspension of or imposing any clinical hold on any clinical trials that are described or referred to in the 2026 SEC Reports; and (v) the Company and its Significant Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.
3.21 Compliance with Health Care Laws. The Company and its Significant Subsidiaries are in compliance in all material respects with all Health Care Laws to the extent applicable to the Company’s current business and research use only products. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)); (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) the European Union (“EU”) Clinical Trials Regulation (Regulation (EU) No. 536/2014); (vi) the EU Regulation regarding community procedures for authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Regulation (EC) No. 726/2004); (vii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; (viii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Significant Subsidiaries, and (ix) the regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any of its Significant Subsidiaries has received written or, to the Company’s Knowledge, oral notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s Knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its Significant Subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its Significant Subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, any of its Significant Subsidiaries nor any of their respective employees, officers, directors, or, to the Knowledge of the Company, agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the Knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.
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3.22 Accounting Controls and Disclosure Controls and Procedures. The Company maintains a system of internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) that is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP, including policies and procedures sufficient to provide reasonable assurance (i) that the Company maintains records that in reasonable detail accurately and fairly reflect the Company’s transactions and dispositions of assets, (ii) that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, (iii) that receipts and expenditures are made only in accordance with authorizations of management and the Board of Directors and (iv) regarding prevention or timely detection of the unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the Company’s financial statements. Except as disclosed in the Company’s SEC Reports filed prior to the date hereof, the Company has not identified any material weaknesses in the design or operation of the Company’s internal control over financial reporting. The Company’s “disclosure controls and procedures” (as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act) are designed to provide reasonable assurance that all information (both financial and non-financial) required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC, and that all such information is accumulated and communicated to the Company’s management as appropriate to allow timely decisions regarding required disclosure.
3.23 Price Stabilization of Common Stock. The Company has not taken, nor will it take, directly or indirectly, any action designed to stabilize or manipulate the price of the Common Stock to facilitate the sale or resale of the Shares or the Underlying Shares.
3.24 Investment Company Act. The Company is not, and immediately after receipt of payment for the Common Stock will not be, an “investment company” within the meaning of the U.S. Investment Company Act of 1940, as amended.
3.25 General Solicitation; No Integration or Aggregation. Neither the Company nor any other person or entity authorized by the Company to act on its behalf has engaged in a general solicitation or general advertising (within the meaning of Regulation D of the Securities Act) of investors with respect to offers or sales of Common Stock pursuant to this Agreement. The Company has not, directly or indirectly, sold, offered for sale, solicited offers to buy or otherwise negotiated in respect of, any security (as defined in the Securities Act) which, to its Knowledge, is or will be (i) integrated with the Shares sold pursuant to this Agreement for purposes of the Securities Act or (ii) aggregated with prior offerings by the Company for the purposes of the rules and regulations of the Nasdaq Global Market. Assuming the accuracy of the representations and warranties of the Investor set forth in Section 4, neither the Company nor any of its Affiliates, its Significant Subsidiaries nor any Person acting on their behalf has, directly or indirectly, made any offers or sales of any Company security or solicited any offers to buy any Company security, under circumstances that would adversely affect reliance by the Company on Section 4(a)(2) and/or Rule 506 of Regulation D promulgated thereunder for the exemption from registration for the transactions contemplated hereby.
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3.26 Brokers and Finders. Neither the Company nor any other Person authorized by the Company to act on its behalf has retained, utilized or been represented by any broker or finder in connection with the transactions contemplated by this Agreement.
3.27 Reliance by the Investor. The Company acknowledges that the Investor will rely upon the truth and accuracy of, and the Company’s compliance with, the representations, warranties, agreements, acknowledgements and understandings of the Company set forth herein.
3.28 No Disqualification Events. With respect to the Shares to be offered and sold hereunder in reliance on Rule 506 under the Securities Act, neither the Company nor any of its (i) predecessors, (ii) affiliates, (iii) directors, (iv) executive officers, (v) non-executive officers participating in the placement contemplated by this Agreement, (vi) beneficial owners of 20% or more of its outstanding voting equity securities (calculated on the basis of voting power), (vii) promoters, or (viii) investment managers (including any of such investment managers’ directors, executive officers or officers participating in the placement contemplated by this Agreement) or general partners or managing members of such investment managers (including any of such general partners’ or management members’ directors, executive officers or officers participating in the placement contemplated by this Agreement) (each, an “Issuer Covered Person” and, together, “Issuer Covered Persons”) is subject to the disqualification provisions of Rule 506(d)(1)(i-viii) of Regulation D under the Securities Act (a “Disqualification Event”).
3.29 Other Covered Persons. The Company is not aware of any person (other than any Issuer Covered Person) that has been or will be paid (directly or indirectly) remuneration for solicitation of purchasers in connection with the sale of any Shares.
3.30 Notice of Disqualification Events. The Company will notify the Investor in writing, prior to the Closing Date of (i) any Disqualification Event relating to any Issuer Covered Person and (ii) any event that would, with the passage of time, reasonably be expected to become a Disqualification Event relating to any Issuer Covered Person, in each case of which it is aware.
3.31 No Stockholder Approval. Other than with regard to the approval of the Authorized Increase Amendment, no vote or approval of the Company’s stockholders is required to approve this Agreement or the transactions contemplated hereby.
3.32 Anti-Bribery and Anti-Money Laundering Laws. Each of the Company, its Significant Subsidiaries and, to the Knowledge of the Company, any of their respective officers, directors, supervisors, managers, agents, or employees are and have at all times been in compliance with and its participation in the offering will not violate: (A) anti-bribery laws, including but not limited to, any applicable law, rule, or regulation of any locality, including but not limited to any law, rule, or regulation promulgated to implement the OECD Convention on Combating Bribery of Foreign Public Officials in International Business Transactions, signed December 17, 1997, including the U.S. Foreign Corrupt Practices Act of 1977, as amended, the U.K. Bribery Act 2010, or any other law, rule or regulation of similar purposes and scope or (B) anti-money laundering laws, including, but not limited to, applicable federal, state, international, foreign or other laws,
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regulations or government guidance regarding anti-money laundering, including, without limitation, Title 18 US. Code sections 1956 and 1957, the Patriot Act, the Bank Secrecy Act, and international anti-money laundering principles or procedures by an intergovernmental group or organization, such as the Financial Action Task Force on Money Laundering, of which the United States is a member and with which designation the United States representative to the group or organization continues to concur, all as amended, and any executive order, directive, or regulation pursuant to the authority of any of the foregoing, or any orders or licenses issued thereunder.
3.33 Cybersecurity. The Company and its Significant Subsidiaries’ information technology assets and equipment, computers, systems, networks, hardware, software, websites, applications, and databases (collectively, “IT Systems”) are adequate for, and operate and perform in all material respects as required in connection with the operation of the business of the Company and its Significant Subsidiaries as currently conducted, and, to the Knowledge of the Company, are free and clear of all material Trojan horses, time bombs, malware and other malicious code. The Company and its Significant Subsidiaries have implemented and maintained commercially reasonable physical, technical and administrative controls designed to maintain and protect the confidentiality, integrity, availability, privacy and security of all sensitive, confidential or regulated data (“Confidential Data”) used or maintained in connection with their businesses and Personal Data (defined below), and the integrity, availability continuous operation, redundancy and security of all IT Systems. “Personal Data” means the following data used in connection with the Company’s and its Significant Subsidiaries’ businesses and in their possession or control: (i) a natural person’s name, street address, telephone number, e-mail address, photograph, social security number or other tax identification number, driver’s license number, passport number, credit card number or bank information; (ii) information that identifies or may reasonably be used to identify an individual; (iii) any information that would qualify as “protected health information” under the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (collectively, “HIPAA”); and (iv) any information that would qualify as “personal data,” “personal information” (or similar term) under the Privacy Laws. To the Company’s Knowledge, there have been no breaches, outages or unauthorized uses of or access to the Company’s IT Systems, Confidential Data, or Personal Data that would require notification under Privacy Laws (as defined below).
3.34 Compliance with Data Privacy Laws. The Company and its Significant Subsidiaries are, and at all prior times were, in material compliance with all applicable state, federal and foreign data privacy and security laws and regulations regarding the collection, use, storage, retention, disclosure, transfer, disposal, or any other processing (collectively “Processing”) of Personal Data, including without limitation HIPAA, the EU General Data Protection Regulation (Regulation (EU) No. 2016/679), all other local, state, federal, national, supranational and foreign laws relating to the regulation of the Company or its Significant Subsidiaries, and the regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof (collectively, the “Privacy Laws”). To ensure material compliance with the Privacy Laws, the Company and its Significant Subsidiaries have in place, comply with, and take all appropriate steps necessary to ensure compliance in all material respects with their policies and procedures relating to data privacy and security, and the Processing of Personal Data and Confidential Data (the “Privacy Statements”). The Company and its Significant Subsidiaries have, except as would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect, at all times since inception provided accurate notice of its Privacy Statements then in effect to its customers, employees, third party vendors and representatives. None of such disclosures made or contained in any Privacy Statements have been materially inaccurate, misleading, incomplete, or in material violation of any Privacy Laws.
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3.35 Transactions with Affiliates and Employees. No relationship, direct or indirect, exists between or among the Company, on the one hand, and the directors, officers, stockholders, customers or suppliers of the Company, on the other hand, that is or would be required to be described in the SEC Reports that is not so described.
3.36 Reliance. The Company has a reasonable basis for making each of the representations set forth in this Section 3. The Company acknowledges that the Investor is relying upon the accuracy and truthfulness of the foregoing representations made by the Company hereunder.
3.37 Shell Company Status. The Company is not, and has never been, an issuer identified in Rule 144(i)(1).
3.38 Material Contracts. Each Material Contract is valid and binding on the Company and each Significant Subsidiary of the Company that is a party thereto and, to the Company’s Knowledge, each other party thereto and is enforceable in accordance with its terms, and is in full force and effect, except where the failure to be valid and binding and in full force and effect, individually or in the aggregate, has not had, and would not reasonably be expected to have, a Material Adverse Effect. The Company and each of its Significant Subsidiaries, and, to the Company’s Knowledge, any other party thereto, has performed all material obligations required to be performed by it under each Material Contract. No event has occurred that, whether or not with notice or lapse of time or both, would constitute a breach or default under, or result in an acceleration of rights or an event of termination pursuant to, any Material Contract by the Company or any of its Significant Subsidiaries, or, to the Company’s Knowledge, any other party thereto. As of the date hereof, neither the Company nor any of its Significant Subsidiaries has received written notice that it has breached, violated or defaulted under any Material Contract. The Company has made available (via EDGAR or otherwise) to the Investor a true and correct copy of each Material Contract (including all amendments thereto), other than any Material Contract of the type set forth in clause (iii) of the definition thereof.
4. Representations and Warranties of The Investor. The Investor represents and warrants to the Company that the statements contained in this Section 4 are true and correct as of the date hereof and the Closing Date:
4.1 Organization. The Investor is duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization and has the requisite power and authority to own, lease and operate its properties and to carry on its business as now conducted.
4.2 Authorization. The Investor has all requisite corporate or similar power and authority to enter into this Agreement and the other Transaction Agreements to which it will be a party and to carry out and perform its obligations hereunder and thereunder. All corporate, member or partnership action on the part of the Investor or its stockholders, members or partners necessary for the authorization, execution, delivery and performance of this Agreement and the other
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Transaction Agreements to which it will be a party and the consummation of the other transactions contemplated herein has been taken. The signature of the Investor on this Agreement is genuine and the signatory to this Agreement, if the Investor is an individual, has the legal competence and capacity to execute the same or, if the Investor is not an individual, the signatory has been duly authorized to execute the same on behalf of the Investor. Assuming this Agreement constitutes the legal and binding agreement of the Company, 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).
4.3 No Conflicts. The execution, delivery and performance of the Transaction Agreements by the Investor, the purchase of the Shares in accordance with their terms and the consummation by the Investor of the other transactions contemplated hereby will not conflict with or result in any violation of, breach or default by the Investor (with or without notice or lapse of time, or both) under, conflict with, or give rise to a right of termination, cancellation or acceleration of any obligation, a change of control right or to a loss of a material benefit under (i) any provision of the organizational documents of the Investor, including, without limitation, its incorporation or formation papers, bylaws, indenture of trust or partnership or operating agreement, as may be applicable or (ii) any agreement or instrument, undertaking, credit facility, franchise, license, judgment, order, ruling, statute, law, ordinance, rule or regulations, applicable to the Investor or its respective properties or assets, except, in the case of clause (ii), 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.
4.4 Residency. The Investor’s offices in which its investment decision with respect to the Shares was made are located at the address specified in Section 8.3(b).
4.5 Brokers and Finders. The Investor has not retained, utilized or been represented by any broker or finder in connection with the transactions contemplated by this Agreement whose fees the Company would be required to pay.
4.6 Investment Representations and Warranties. The Investor hereby represents and warrants that it, as of the date hereof, 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 it is capable of evaluating the merits and risk of such investment. The Investor understands and agrees that the offering and sale of the Shares has not been registered under the Securities Act or any applicable state securities laws and is being made in reliance upon federal and state exemptions for transactions not involving a public offering which depend upon, among other things, the bona fide nature of the investment intent and the accuracy of the Investor’s representations as expressed herein.
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4.7 Intent. The Investor is purchasing the Shares solely for investment purposes, for the Investor’s own account and not for the account of others, and not with a view to the resale or distribution of any part thereof in violation of the Securities Act, and the Investor has no present intention of selling, granting any participation in, or otherwise distributing the same in violation of the Securities Act without prejudice, however, to the Investor’s right at all times to sell or otherwise dispose of all or any part of such Shares in compliance with applicable federal and state securities laws. Notwithstanding the foregoing, if the Investor is purchasing the Shares as a fiduciary or agent for one or more investor accounts, the Investor has full investment discretion with respect to each such account, and the full power and authority to make the acknowledgements, representations and agreements herein on behalf of each owner of each such account. The Investor has no present arrangement to sell the Shares to or through any person or entity. The Investor understands that the Shares must be held indefinitely unless such Shares are resold pursuant to a registration statement under the Securities Act or an exemption from registration is available. Nothing contained herein shall be deemed a representation or warranty by the Investor to hold the Shares for any period of time.
4.8 Investment Experience; Ability to Protect Its Own Interests and Bear Economic Risks. The Investor acknowledges that it can bear the economic risk and complete loss of its investment in the Shares and has knowledge and experience in finance, securities, taxation, investments and other business matters as to be capable of evaluating the merits and risks of investments of the kind described in this Agreement and contemplated hereby, and the Investor has had an opportunity to seek, and has sought, such accounting, legal, business and tax advice as the Investor has considered necessary to make an informed investment decision.
The Investor acknowledges that the Investor (i) is a sophisticated investor, experienced in investing in private placements of equity securities and capable of evaluating investment risks independently, both in general and with regard to all transactions and investment strategies involving a security or securities and (ii) has exercised independent judgment in evaluating its participation in the purchase of the Shares. The Investor acknowledges that the Investor is aware that there are substantial risks incident to the purchase and ownership of the Shares, including those set forth in the Company’s filings with the SEC. Alone, or together with any professional advisor(s), the Investor has adequately analyzed and fully considered the risks of an investment in the Shares and determined that the Shares are a suitable investment for the Investor. The Investor is, at this time and in the foreseeable future, able to afford the loss of the Investor’s entire investment in the Shares and the Investor acknowledges specifically that a possibility of total loss exists.
4.9 Independent Investment Decision. The Investor understands that nothing in the Transaction Agreements or any other materials presented by or on behalf of the Company 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 its sole discretion, has deemed necessary or appropriate in connection with its purchase of the Shares.
4.10 Shares Not Registered; Legends. The Investor acknowledges and agrees that the Shares are being offered in a transaction not involving any public offering within the meaning of the Securities Act, and the Investor understands that the Shares have not been registered under the Securities Act, by reason of their issuance by the Company in a transaction exempt from the registration requirements of the Securities Act, and that the Shares must continue to be held and may not be offered, resold, transferred, pledged or otherwise disposed of by the Investor unless a subsequent disposition thereof is registered under the Securities Act or is exempt
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from such registration and in each case in accordance with any applicable securities laws of any state of the United States. The Investor understands that the exemptions from registration afforded by Rule 144 (the provisions of which are known to it) promulgated under the Securities Act depend on the satisfaction of various conditions including, but not limited to, the time and manner of sale, the holding period and on requirements relating to the Company which are outside of the Investor’s control and which the Company may not be able to satisfy, and that, if applicable, Rule 144 may afford the basis for sales only in limited amounts. 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. 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.
The Investor understands that any certificates or book entry notations evidencing the Shares may bear one or more legends in substantially the following form and substance:
“THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR THE SECURITIES LAWS OF ANY STATE OF THE UNITED STATES. THE SECURITIES HAVE BEEN ACQUIRED FOR INVESTMENT AND MAY NOT BE SOLD, TRANSFERRED OR ASSIGNED UNLESS (I) SUCH SECURITIES HAVE BEEN REGISTERED FOR SALE PURSUANT TO THE SECURITIES ACT, (II) SUCH SECURITIES MAY BE SOLD PURSUANT TO RULE 144, (III) THE COMPANY HAS RECEIVED AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO IT THAT SUCH TRANSFER MAY LAWFULLY BE MADE WITHOUT REGISTRATION UNDER THE SECURITIES ACT, OR (IV) THE SECURITIES ARE TRANSFERRED WITHOUT CONSIDERATION TO AN AFFILIATE OF SUCH HOLDER OR A CUSTODIAL NOMINEE (WHICH FOR THE AVOIDANCE OF DOUBT SHALL REQUIRE NEITHER CONSENT NOR THE DELIVERY OF AN OPINION).”
In addition, the Shares may contain a legend regarding affiliate status of the Investor, if applicable.
4.11 No General Solicitation. The Investor acknowledges and agrees that the Investor is purchasing the Shares directly from the Company. Investor became aware of this offering of the Shares solely by means of direct contact from the Company as a result of a pre-existing, substantive relationship with the Company and/or their respective 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 Company and/or their respective representatives. Investor did not become aware of this offering of the Shares, nor were the Shares offered to Investor, by any other means, and none of the Company 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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4.12 Access to Information. In making its decision to purchase the Shares, Investor has relied solely upon independent investigation made by Investor, upon the SEC Reports and upon the representations, warranties and covenants set forth herein. The Investor acknowledges and agrees that the Investor has received such information as the Investor deems necessary in order to make an investment decision with respect to the Shares, including, with respect to the Company. Without limiting the generality of the foregoing, the Investor acknowledges that copies of the 2026 SEC Reports are available on EDGAR at www.sec.gov. The Investor acknowledges and agrees that the Investor and the Investor’s professional advisor(s), if any, have had the opportunity to ask such questions, receive such answers and obtain such information from the Company regarding the Company, its business and the terms and conditions of the offering of the Shares as the Investor and the Investor’s professional advisor(s), if any, have deemed necessary to make an investment decision with respect to the Shares and that the Investor has independently made its own analysis and decision to invest in the Company. Neither such inquiries nor any other due diligence investigation conducted by the Investor shall modify, limit or otherwise affect the Investor’s right to rely on the Company’s representations and warranties contained in this Agreement.
4.13 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 Short Sales, of the securities of the Company during the period commencing as of the time that the Investor was first contacted by the Company or any other Person regarding the transaction contemplated hereby and ending immediately prior to the date hereof. Notwithstanding the foregoing, the representation set forth above shall not apply to any purchase or sale of securities of the Company (a) effected by or on behalf of any pension plan, benefit plan trust, treasury function or index-tracking or passively managed account of the Investor or any of its Affiliates, in each case where the investment decision was made without the direction of, and by persons having no knowledge of, the transactions contemplated hereby, or (b) effected by any Affiliate of the Investor that is subject to information barriers reasonably designed to prevent the communication of information regarding the transactions contemplated hereby. Other than to other Persons party to this Agreement and to its advisors and agents who had a need to know such information, 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). Notwithstanding the foregoing, for avoidance of doubt, nothing contained herein shall constitute a representation or warranty, or preclude any actions, with respect to the identification of the availability of, or securing of, available shares to borrow in order to effect Short Sales or similar transactions in the future.
4.14 Disqualification Event. To the extent the Investor is one of the covered persons identified in Rule 506(d)(1), the Investor represents that no Disqualification Event is applicable to the Investor or any of its Rule 506(d) Related Parties (as defined below), except, if applicable, for a Disqualification Event as to which Rule 506(d)(2)(ii) or (iii) or (d)(3) is applicable. The Investor hereby agrees that it shall notify the Company promptly in writing in the event a Disqualification Event becomes applicable to the Investor or any of its Rule 506(d) Related Parties, except, if applicable, for a Disqualification Event as to which Rule 506(d)(2)(ii) or (iii) or (d)(3) is applicable. For purposes of this Section, “Rule 506(d) Related Party” means a person or entity that is a beneficial owner of the Investor’s securities for purposes of Rule 506(d) of the Securities Act.
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4.15 Sufficiency of Funds. At the Closing, the Investor will have sufficient cash on hand or other sources of immediately available funds to enable it to make payment of the Aggregate Purchase Amount (and any other amounts owing hereunder) and consummate the transactions contemplated hereunder.
5. Covenants.
5.1 Further Assurances. Each party agrees to cooperate with each other and their respective officers, employees, attorneys, accountants and other agents, and, generally, do such other reasonable acts and things in good faith as may be necessary to effectuate the intents and purposes of this Agreement, subject to the terms and conditions hereof and compliance with applicable law, including taking reasonable action to facilitate the filing of any document or the taking of reasonable action to assist the other parties hereto in complying with the terms hereof. The Investor acknowledges that the Company 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 Company if any of the acknowledgments, understandings, agreements, representations and warranties set forth in Section 4 of this Agreement are no longer accurate.
5.2 Listing. The Company shall use commercially reasonable efforts to maintain the listing and trading of its Common Stock on the Nasdaq Global Market and, in accordance therewith, will use reasonable best efforts to comply in all material respects with the Company’s reporting, filing and other obligations under the rules and regulations of Nasdaq.
5.3 Disclosure of Transactions. The Company shall, by 5:30 p.m., New York City time, on the first (1st) Business Day immediately following the date hereof, file with the SEC one or more Current Reports on Form 8-K (including all exhibits thereto, the “Disclosure Documents”) disclosing all material terms of the transactions contemplated hereby and by the other Transaction Agreements and attaching this Agreement and the other Transaction Agreements as exhibits to such Disclosure Documents; provided that the Company shall allow the Investor reasonable time to comment on such Disclosure Documents in advance of such filing (and the Company shall consider such comments in good faith).
5.4 Integration. The Company shall not, and shall use its commercially reasonable efforts to ensure that no Affiliate of the Company 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 integrated with the offer or sale of the Shares for purposes of the rules and regulations of any National Exchange 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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5.5 Removal of Legends.
(a) In connection with any sale, assignment, transfer or other disposition of the Underlying 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 Company, the Company shall request the Transfer Agent 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 Company has timely received from the Investor customary representations and other documentation reasonably acceptable to the Company in connection therewith. The Company shall be responsible for the fees of its Transfer Agent and its legal counsel associated with such legend removal.
(b) Subject to receipt from the Investor by the Company and the Transfer Agent of customary representations and other documentation reasonably acceptable to the Company and the Transfer Agent in connection therewith, upon the earliest of such time as the Underlying Shares (i) have been registered under the Securities Act pursuant to an effective registration statement or (ii) have been sold pursuant to Rule 144, the Company shall, in accordance with the provisions of this Section 5.5 and as soon as reasonably practicable following any request therefor from the Investor accompanied by such customary and reasonably acceptable documentation referred to above, (A) deliver to the Transfer Agent irrevocable 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.
5.6 Withholding Taxes. The Investor agrees to furnish the Company with any information, representations and forms as shall reasonably be requested by the Company from time to time to assist the Company in complying with any applicable tax law (including any withholding obligations).
5.7 Fees and Taxes. The Company shall be solely responsible for the payment of any 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.
5.8 No Conflicting Agreements. The Company will not take any action, enter into any agreement or make any commitment that would conflict or interfere in any material respect with the Company’s obligations to the Investor under the Transaction Agreements.
5.9 Reporting Status. The Company shall timely file all reports required to be filed with the SEC pursuant to the Exchange Act, and the Company shall not terminate its status as an issuer required to file reports under the Exchange Act even if the Exchange Act or the rules and regulations thereunder would otherwise permit such termination.
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5.10 Indemnification.
(a) The Company agrees to indemnify and hold harmless the Investor and its Affiliates, and their respective directors, officers, trustees, members, managers, employees, investment advisers 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 Indemnified Person becomes subject as a result of any breach of representation, warranty, covenant or agreement made by or to be performed on the part of the Company under the Transaction Agreements, and will reimburse any such Indemnified Person for all such amounts as they are incurred by such Indemnified Person solely to the extent such amounts have been finally judicially determined not to have resulted from such Indemnified Person’s fraud or willful misconduct.
(b) Any Indemnified Person shall (i) give prompt written notice to the indemnifying party of any claim with respect to which it seeks indemnification and (ii) solely with respect to such claims brought by third parties, permit such indemnifying party to assume the defense of such claim with counsel reasonably satisfactory to the indemnified party; provided that any Indemnified Person 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 Indemnified 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 Indemnified Person or (C) in the reasonable judgment of any such Indemnified Person, based upon written advice of its counsel, a conflict of interest exists between such Indemnified Person and the indemnifying party with respect to such claims (in which case, if the Indemnified Person notifies the indemnifying party in writing that such Indemnified 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 Indemnified 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. In connection with a third-party claim, 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 unreasonably, except with the consent of the indemnifying party, withhold, condition or delay, consent to entry of any judgment or enter into any settlement. Notwithstanding anything to the contrary contained in this Agreement, the Company shall have no obligation to indemnify the Investor or any of its Affiliates with respect to any action, claim or proceeding, pending or threatened brought derivatively in the right of the Investor by one or more direct or indirect equity holders of the Investor, solely in their capacities as such, against the Investor or any of its Affiliates, partners, members, managers, directors, officers or other representatives.
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5.11 Subsequent Equity Sales in a Public Offering. From the date hereof until the earlier of (a) sixty (60) days after the Closing Date and (b) the Business Day immediately following the effective date of the registration statement filed pursuant to the Registration Rights Agreement, the Company shall not (A) effect a reverse stock split, recapitalization, share consolidation, reclassification or similar transaction affecting the outstanding Common Stock or (B) file with the SEC a registration statement under the Securities Act relating to any shares of Common Stock or Common Stock Equivalents, except pursuant to the terms of the Registration Rights Agreement. Notwithstanding the foregoing, the provisions of this Section 5.11 shall not apply to the filing of a registration statement on Form S-8 under the Securities Act to register the offer and sale of securities on an equity incentive plan or employee stock purchase plan.
5.12 Regulatory Approvals.
(a) Each of the Company and the Investor shall, if applicable, (i) file, as promptly as practicable (and in any event no later than twenty (20) Business Days) after the date (the “Notification Date”) on which the Investor delivers to the Company notice in writing that the Investor wishes to convert the Shares pursuant to the Certificate of Designations (which notice may be delivered by the Investor at any time in its sole discretion), the notification and report form as required under the HSR Act with respect to the acquisition of the Underlying Shares by the Investor prior to conversion of the Shares pursuant to the Certificate of Designations, and (ii) make, as promptly as practicable after the Notification Date, all other filings, notifications and submissions with any Governmental Entity as are required under any other antitrust, competition, merger control or foreign investment law in connection with such acquisition. Each party shall use its reasonable best efforts to obtain the Regulatory Approvals as promptly as practicable following notice from the Investor of an intention to convert the Shares, including by supplying as promptly as practicable any additional information or documentary material that may be requested by any Governmental Entity.
(b) The Company and the Investor shall cooperate with one another in good faith to (i) promptly determine whether any filing or notification is required to be made, or any consent, approval, clearance or authorization is required to be obtained, from any Governmental Entity under any antitrust, competition, merger control or foreign investment law in connection with the acquisition of the Underlying Shares by the Investor on conversion of the Shares pursuant of the Certificate of Designations and (ii) if applicable, promptly make any such filing, furnish the information required in connection therewith and seek to obtain timely any such consent, approval, clearance or authorization that the parties determine is so required.
(c) Each party shall, subject to any restrictions under applicable law, (i) promptly notify the other of, and furnish the other with copies of (or, in the case of oral communications, advise the other of the contents of), any material communication received by it from a Governmental Entity in connection with the foregoing provisions of this Section 5.12 (and, where relevant, the acquisition of the Shares), and permit the other to review and discuss in advance, and consider in good faith any comments made by the other in relation to, any proposed
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draft filing, submission or other written communication to a Governmental Entity; (ii) keep the other reasonably informed on a current basis with respect to the status of any such filing or submission and of any developments, meetings or discussions with any Governmental Entity in respect thereof; and (iii) not independently participate in any meeting, hearing, proceeding or substantive discussion with or before any Governmental Entity in respect of the transactions contemplated hereby without giving the other reasonable prior notice and, unless prohibited by such Governmental Entity, the opportunity to attend or participate. Either party may designate any non-public or competitively sensitive information provided to a Governmental Entity as restricted to outside counsel only, and may redact valuation and related information, before sharing such information with the other party. The Investor shall solely determine the strategy for obtaining any Regulatory Approvals, including under the HSR Act.
(d) Notwithstanding anything to the contrary contained in this Agreement, neither the Company nor the Investor nor any of their respective Affiliates shall be required to (x) litigate or contest any administrative or judicial action or proceeding or any order, writ, injunction, judgment or decree, whether temporary, preliminary or permanent, challenging or seeking to restrain, prohibit or place conditions on the consummation of the transactions contemplated by this Agreement (including the conversion of the Shares pursuant to the Certificate of Designations) or (y) agree to, offer, negotiate, commit to or effect, by consent decree, hold separate order or otherwise, (i) the sale, divestiture, transfer, license, disposition or holding separate of any capital stock or other equity or voting interest, assets (whether tangible or intangible), rights, properties, products or businesses of the Company or the Investor or any of their respective Affiliates; (ii) the termination, modification or assignment of any existing relationship, joint venture, contract or obligation of the Company or the Investor or any of their respective Affiliates; (iii) the modification of any course of conduct regarding the future operations of the Company or the Investor or any of their respective Affiliates; (iv) any other restriction on the activities of the Company or the Investor or any of their respective Affiliates, including on the ownership, voting or exercise of rights in respect of the Shares or the Underlying Shares (other than as provided in the last sentence of this Section 5.12(d)); (v) the initiation, contest, defense or appeal of any action or proceeding against any Governmental Entity; or (vi) any commitment to seek prior approval from any Governmental Entity of any future transaction. Solely for purposes of clarity, nothing contained in this Section 5.12(d) shall in any way impact the obligations of the Investor set forth in Section 5.18 of this Agreement.
5.13 Conduct of the Business. Except (x) as required by applicable law, (y) as consented to in writing by the Investor, or (z) as required or expressly provided for by this Agreement, during the period from the date hereof until the earlier of the Closing or the valid termination of this Agreement pursuant to Section 7, (a) the Company shall use its commercially reasonable efforts to conduct its operations in all material respects in the ordinary course of business and (b) without limiting the generality of the foregoing, the Company shall not, and shall cause each of its Significant Subsidiaries not to declare, set aside, make or pay any dividend or distribution (whether in cash, stock or property) on any shares of its capital stock.
5.14 Information Rights; Financial Reporting Cooperation. From and after the Closing, the Company shall provide the Investor with information sufficient to enable the Investor to account for its investment in accordance with IFRS and satisfy its financial reporting obligations.
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5.15 Preemptive Rights.
(a) Subject to Section 5.15(g), after the Closing and for so long as the Investor and its Affiliates collectively beneficially own (within the meaning of Rule 13d-3 under the Exchange Act) at least fifty percent (50%) of the Shares purchased from the Company under this Agreement (treating, for this purpose, any Underlying Shares then held as the Shares from which they were converted), if the Company proposes to issue any shares of Common Stock or any Common Stock Equivalents to any Person, the Investor shall have the right (the “Preemptive Right”), but not the obligation, to purchase its Proportionate Percentage of such shares of Common Stock or Common Stock Equivalents, at a price per security equal to the lowest price per security at which such securities are to be offered in such issuance and otherwise on the same terms as those on which such securities are proposed to be issued and sold. As used in this Section 5.15 “Proportionate Percentage” means, with respect to any issuance, the percentage equal to (i) the number of shares of Common Stock, determined on an as-converted basis, collectively beneficially owned (within the meaning of Rule 13d-3 under the Exchange Act) by the Investor and its Affiliates divided by (ii) the number of shares of Common Stock issued and outstanding, in each case as of the close of business on the date of the applicable Preemptive Offer Notice. In the case of a proposed issuance of Common Stock or any Common Stock Equivalents for consideration in whole or in part other than cash, including securities acquired in exchange therefor, the consideration other than cash shall be deemed to be cash in an amount equal to the fair value of such consideration as reasonably determined by the Board of Directors; provided, that such fair value as determined by the Board of Directors shall not exceed the aggregate market price of the securities being offered as of the date the Board of Directors authorizes the offering of such securities.
(b) Not later than seven (7) Business Days prior to any issuance giving rise to the Preemptive Right under Section 5.15(a), the Company shall deliver to the Investor a notice (the “Preemptive Offer Notice”) that (i) includes the principal terms and conditions of the proposed issuance, including (A) the number and type of securities proposed to be issued, (B) the price per security and (C) the proposed issuance date, (ii) sets forth the Investor’s Proportionate Percentage and (iii) offers to sell to the Investor its Proportionate Percentage of such securities at the price and on the terms and conditions set forth therein. For clarity, a Preemptive Offer Notice shall not be required to disclose the name of any Person participating in such proposed issuance. The Preemptive Offer Notice shall by its terms remain open for a period of seven (7) Business Days from the date of delivery thereof (the “Election Period”) and shall specify the date on which such securities will be sold to the Investor if the Investor accepts (which shall be at least five (5) Business Days but not more than 180 days after the date of delivery of the Preemptive Offer Notice). The failure of the Investor to respond to the Preemptive Offer Notice prior to the end of the Election Period shall be deemed a waiver of the Preemptive Right with respect to the applicable Preemptive Offer Notice.
(c) The Investor shall have the right, during the Election Period, to elect to purchase any or all of its Proportionate Percentage of the securities offered at the purchase price and on the terms stated in the Preemptive Offer Notice. Notice by the Investor of its acceptance, in whole or in part, of the offer set forth in the Preemptive Offer Notice (a “Notice of Acceptance”) shall be irrevocable, shall be signed by the Investor and shall be delivered to the Company prior to the end of the Election Period, setting forth the number of securities the Investor elects to purchase.
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(d) Notwithstanding the advance notice requirement set forth in Section 5.15(b), if the proposed issuance is an underwritten public offering or other registered offering, or if the Board of Directors determines that other special circumstances warrant, the Company may deliver the Preemptive Offer Notice after the issuance of the securities (the “Issuance”), in which case (i) the Company shall deliver the Preemptive Offer Notice no later than two (2) Business Days after the Issuance, (ii) the Election Period shall run for seven (7) Business Days from the date of delivery thereof and (iii) if the Investor delivers a Notice of Acceptance within the Election Period, the Company shall issue and sell to the Investor that number of shares of Common Stock or Common Stock Equivalents equal to the Investor’s Proportionate Percentage of the securities issued in the Issuance, determined immediately prior to the Issuance, at the price and otherwise on the terms determined in accordance with Section 5.15(a).
(e) The closing of any purchase pursuant to this Section 5.15 shall take place on the proposed issuance date set forth in the Preemptive Offer Notice or, in the case of a purchase pursuant to Section 5.15(d), within five (5) Business Days after delivery of the Notice of Acceptance; provided, that the consummation of any such purchase may be extended beyond such date to the extent necessary to obtain any applicable approval of a Governmental Entity, including the expiration or termination of any applicable waiting period under the HSR Act, or to satisfy any other condition set forth in the Preemptive Offer Notice. At such closing, the Company shall issue the securities so purchased in book-entry form, registered in the name of the Investor or such nominee name as the Investor shall designate, free and clear of all liens (other than any arising under applicable securities laws), against payment by the Investor of the applicable purchase price by wire transfer of United States dollars in immediately available funds, and shall provide the Investor with evidence of such issuance. At or prior to such closing, the Investor shall execute and deliver to the Company any agreements or other documentation in substantially similar forms to those executed and delivered by other purchasers in such transaction. Each of the Company and the Investor shall take, or cause to be taken, all such reasonable actions as may be reasonably necessary or reasonably desirable in order to consummate such purchase expeditiously, including executing, acknowledging and delivering consents, waivers and other documents or instruments and making filings with Governmental Entities.
(f) If a Notice of Acceptance given by the Investor does not cover in the aggregate all of the securities offered to it, the Company may, during the 180 days following the end of the Election Period, sell to any other Person or Persons all or any part of the securities not covered by such Notice of Acceptance, but only on terms and conditions that are no more favorable, with respect to price or other material terms in the aggregate, to such Person or Persons, or less favorable, with respect to price or other material terms in the aggregate, to the Company, than those set forth in the Preemptive Offer Notice. If such sale is not consummated within such 180-day period for any reason, then the restrictions provided for in this Section 5.15 shall again become effective.
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(g) The Preemptive Right shall not apply to (i) issuances or sales of securities to employees, officers, directors or consultants of the Company or any of its Significant Subsidiaries pursuant to employee benefit plans or similar employee or management equity incentive plans or arrangements of the Company or any of its Significant Subsidiaries, including any employee stock purchase plan; (ii) issuances or sales to a Person in connection with an acquisition (or series of acquisitions), business combination or merger approved by the Board of Directors; (iii) issuances of securities pursuant to the exercise, exchange or conversion of Common Stock Equivalents; (iv) issuances of securities pursuant to an “at-the-market” offering or similar facility by the Company; (v) issuances of debt securities in connection with debt financings or similar facilities; (vi) issuances of securities in connection with royalty financing arrangements; or (vii) issuances of securities in connection with strategic partnerships.
(h) The Investor may designate one or more of its Affiliates to purchase all or any portion of the securities as to which the Investor exercises the Preemptive Right, in which case references in this Section 5.15 to a purchase by the Investor shall be read accordingly.
(i) From and after the Investor’s delivery of a Notice of Acceptance until the earlier of (i) thirty (30) days following the consummation of the proposed issuance contemplated by the Preemptive Offer Notice in respect of such Notice of Acceptance and (ii) the date on which the Investor receives written notice from the Company that such issuance has been abandoned, the Investor shall not, and shall cause each of its Affiliates not to, directly or indirectly, offer, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, make any short sale of, or otherwise transfer or dispose of any shares of Common Stock or other securities of the Company, or enter into any swap, hedge or other transaction that transfers, in whole or in part, any of the economic consequences of ownership of any securities of the Company; provided, that (x) nothing in this Section 5.15 shall prohibit the Investor from acquiring securities pursuant to its exercise of its rights under this Section 5.15 and (y) the restrictions set forth in this Section 5.15(i) shall not apply with respect to any proposed issuance if such restrictions have already become applicable with respect to two (2) proposed issuances during the same calendar year.
5.16 Third Party Acquisition Proposals.
(a) From and after the Closing, if the Company receives an Acquisition Proposal and the Board of Directors thereafter (i) determines to consider that Acquisition Proposal or (ii) authorizes the Company or any other Person acting on its behalf to make any counteroffer or engage in any negotiation in respect of the terms of that Acquisition Proposal, then the Company shall provide written notice to the Investor within two (2) Business Days, which notice shall state that an Acquisition Proposal has been received (“Active Bid Notice”).
(b) For a period of ten (10) Business Days following delivery of the Active Bid Notice, the Investor shall have the right, but not the obligation, to submit a proposal for an Acquisition Transaction between the Company and the Investor (an “Investor Offer”). The Company shall promptly respond to the Investor’s reasonable questions and provide the Investor with all reasonably requested due diligence information and materials and access to Company management, in each case on reasonable and customary terms and conditions appropriate to enable the Investor to formulate an Investor Offer. For clarity, it is understood that the Company shall have no obligation to accept the Investor Offer, but the fiduciary obligations of the Board of Directors under applicable law shall nonetheless and in all cases govern the Company’s response to any Investor Offer.
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(c) Notwithstanding the foregoing, the Company shall only be required to provide one Active Bid Notice, and the Investor shall only be entitled to a single ten (10) Business Day notice period under subparagraph (b) above, during any one sixty (60) day period. Accordingly, once the Company has provided an Active Bid Notice to the Investor, the Company shall not be obligated to provide any other Active Bid Notice to the Investor for a period of sixty (60) days thereafter (such period, a “Transaction Window Period”), regardless of whether the Company receives or the Board considers revised or additional proposals from one or more third parties; provided if the Company enters into a definitive Agreement for an Acquisition Transaction during the Transaction Window Period, the Transaction Window Period shall continue until the closing or termination of such Acquisition Transaction. For clarity, however, if Company does not enter into a definitive agreement with respect to an Acquisition Proposal within such Transaction Window Period, then the Company’s obligations under this Section 5.16 shall again apply from and after the end of such Transaction Window Period.
(d) If (i)(A) the Investor declines in writing, or fails to submit an Investor Offer within twenty (20) Business Days after the Active Bid Notice or (B) the Investor submits an Investor Offer and the Board of Directors determines in good faith, after consultation with its financial advisor and outside legal counsel, that the Acquisition Proposal is more favorable, from a financial point of view, to the Company’s stockholders than the Investor Offer, then at any meeting of the stockholders of the Company called to approve the transaction contemplated by such Acquisition Proposal, the Investor shall, and shall cause its Affiliates to, vote all shares of Common Stock beneficially owned by it in accordance with the recommendation of the Board of Directors in respect of such transaction, and (ii) the Investor submits an Investor Offer and the Board of Directors determines in good faith, after consultation with its financial advisor and outside legal counsel, that the Acquisition Proposal is not more favorable, from a financial point of view, to the Company’s stockholders than such Investor Offer, then at any meeting of the stockholders of the Company called to approve the transaction contemplated by such Acquisition Proposal, the Investor shall not be required, nor shall it be required to cause its Affiliates to, vote all shares of Common Stock beneficially owned by it in accordance with the recommendation of the Board of Directors in respect of such transaction. Notwithstanding anything to the contrary set forth in this Section 5.16(d), in no event shall the Investor or any of its Affiliates be required to convert any Shares into Common Stock in order to comply with this Section 5.16(d).
(e) The obligation in Section 5.16(d) (i) shall apply only if the Company has complied in all material respects with Sections 5.16(a) and 5.16(b), and shall terminate upon the earliest of (i) any change, withdrawal, qualification or modification of the recommendation of the Board of Directors in respect of the relevant transaction, (ii) the termination of the definitive agreement governing such transaction and (iii) any amendment to such definitive agreement or to the Acquisition Proposal that reduces the consideration payable to the Company’s stockholders or is otherwise materially adverse to them.
(f) For the avoidance of doubt, it is understood and agreed that Company’s obligations under this Section 5.16 are only those expressly provided in subparagraphs (a)-(d) above, and accordingly without limitation: (i) this Section 5.16 confers no right of first refusal, right of first offer, matching right, veto or other right on the Investor, and (ii) the Company shall have no obligation to disclose the identity of any prospective acquiror, the terms of any Acquisition Proposal, or any other information regarding the Acquisition Proposal beyond the fact of its existence as described above in subparagraph (a) above.
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(g) This Section 5.16 shall automatically expire and be of no further force or effect in its entirety at such time as both of the following conditions are satisfied: (i) the Investor or any of its Affiliates has sold or otherwise disposed of any of the Shares (or any Underlying Shares) purchased from the Company under this Agreement to any person other than an Affiliate of the Investor and (ii) the Investor and its Affiliates cease to collectively beneficially own (within the meaning of Rule 13d-3 under the Exchange Act) at least ten percent (10%) of the outstanding shares of Common Stock (on an as-converted basis).
5.17 Lock-Up.
(a) Subject to the exceptions set forth in Section 5.17(b), (i) from the Closing Date until the first anniversary of the Closing Date or (ii) for thirty (30) days following delivery of an Offering Notice in respect of an offering that the Investor is participating in (any such period, the “Lock-Up Period”), the Investor shall not sell, transfer or assign any Shares or Underlying Shares held by Investor.
(b) Section 5.17(a) shall not apply to any sale, transfer or assignment of Shares or Underlying Shares:
(i) to an Affiliate of the Investor or to a custodial nominee;
(ii) by virtue of laws of the state of the entity’s organization and the entity’s organizational documents upon dissolution of the entity;
(iii) in connection with a change of control of Investor;
(iv) to the Company;
(v) in the event of a liquidation, merger, consolidation, stock exchange, business combination, tender offer or other similar transaction that would result in a change of control of the Company and that is made to, or available to, all holders of Common Stock;
(vi) to the extent the Investor is prohibited by applicable law from withholding the Shares from sale during the Lock-Up Period;
(vii) after commencement by the Company or a Significant Subsidiary of bankruptcy, insolvency or other similar proceedings; or
(viii) made with the prior written consent of the Company.
5.18 Voting. Except as otherwise provided in Section 5.16(c), the Investor shall, at any meeting of the stockholders of the Company, however called, and in any action by written consent of the Company’s shareholders, vote (or consent with respect to) all Underlying Shares (to the extent such Underlying Shares are entitled to vote at such time pursuant to the Certificate of Incorporation and the Certificate of Designations) beneficially owned by the Investor in
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accordance with the recommendation of the Board of Directors with respect to all matters. For the avoidance of doubt, the foregoing agreement to vote or consent shall terminate and be of no further force or effect in respect of any Shares or Underlying Shares held by the Investor that are transferred to or otherwise held by any Person that is not an Affiliate of the Investor.
5.19 Amendment of Certificate of Incorporation; Reservation of Shares.
(a) Prior to the Closing, the Company shall file the Certificate of Designations with the Secretary of State of the State of Delaware.
(b) The Company shall take, or cause to be taken, all actions necessary to cause an amendment to the Amended and Restated Certificate of Incorporation increasing the total number of shares of Common Stock that the Company is authorized to issue to not fewer than 1,250,000,000 shares (and in any event to a number sufficient to permit the issuance in full of the Underlying Shares) (the “Authorized Increase Amendment”), to be duly adopted and to become effective in accordance with the DGCL on or prior to December 31, 2026.
(c) The Company shall at all times from and after January 1, 2027 reserve and keep available out of its authorized and unissued Common Stock, solely for issuance on the conversion of the Convertible Preferred Stock, such number of shares of Common Stock as shall from time to time be issuable on the conversion to Common Stock of all the shares of Convertible Preferred Stock then outstanding.
(d) The Company shall cause any shares of Common Stock issued on conversion of the Convertible Preferred Stock to be duly authorized, validly issued, fully paid and non-assessable, to be free and clear of any liens or other restrictions (other than those as provided in the Transaction Agreements, the Certificate of Designations or restrictions on transfer under applicable state and federal securities laws) and not subject to preemptive rights or subscription rights of any other stockholder of the Company, and the holders thereof shall be entitled to all rights accorded to a holder of Common Stock.
(e) The Company shall notify the Investor in writing promptly, and in any event within two Business Days, following the effectiveness of the amendment contemplated by Section 5.19(b), and shall deliver to the Investor a copy of such amendment as filed with and accepted by the Secretary of State of the State of Delaware.
6. Conditions of Closing.
6.1 Conditions to the Obligation of the Investor. The obligation of the Investor to consummate the transactions to be consummated at the Closing, and to purchase and pay for the Shares being purchased by it at the Closing pursuant to this Agreement, are subject to the satisfaction or waiver in writing of the following conditions precedent:
(a) Representations and Warranties. The representations and warranties of the Company 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 hereof and as of the Closing Date, as though made on and as of such date, except to the extent any such representation or warranty expressly speaks as of an earlier date, in which case such representation or warranty shall be true and correct in all material respects as of such earlier date, except for those representations and warranties qualified by materiality or Material Adverse Effect, which shall be true and correct in all respects as of such earlier date.
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(b) Performance. The Company shall have performed in all material respects the obligations and conditions herein required to be performed or observed by the Company on or prior to the Closing Date.
(c) No Injunction. The purchase of and payment for the Shares by the Investor shall not be prohibited or enjoined by any law or governmental or court order or regulation and no such prohibition shall have been threatened in writing.
(d) Consents. The Company 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.
(e) Certificate of Designations. The Company shall have delivered to the Investor a copy of the Certificate of Designations that has been filed with and accepted (as of the Closing) by the Secretary of State of the State of Delaware.
(f) Adverse Changes. Since the date hereof, no event or series of events shall have occurred that has had or would reasonably be expected to have a Material Adverse Effect.
(g) Compliance Certificate. An authorized officer of the Company shall have delivered to the Investor at the Closing Date a certificate certifying that the conditions specified in Sections 6.1(a) (Representations and Warranties), 6.1(b) (Performance), 6.1(c) (No Injunction), 6.1(d) (Consents), 6.1(e) (Certificate of Designations), 6.1(f) (Adverse Changes), 6.1(j) (Listing Requirements) and 6.1(k) (No Injunction) of this Agreement have been fulfilled.
(h) Secretary’s Certificate. The Secretary of the Company shall have delivered to the Investor at the Closing Date a certificate certifying (i) the Amended and Restated Certificate of Incorporation; (ii) the Amended and Restated Bylaws; and (iii) resolutions of the Board of Directors (or an authorized committee thereof) approving this Agreement, the other Transaction Agreements, the transactions contemplated by this Agreement and the issuance of the Shares.
(i) Registration Rights Agreement. The Company shall have executed and delivered the Registration Rights Agreement in the form attached hereto as Exhibit A (the “Registration Rights Agreement”) to the Investor.
(j) 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 a National Exchange and shall not have been suspended, as of the Closing Date, by the SEC or the National Exchange from trading thereon nor shall suspension by the SEC or the National Exchange have been threatened, as of the Closing Date, in writing by the SEC or the National Exchange.
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(k) No Injunction. No judgment, writ, order, injunction, award or decree of or by any court, or judge, justice or magistrate, including any bankruptcy court or judge, or any order of or by any Governmental Entity, shall have been issued, and no action or proceeding shall have been instituted by any Governmental Entity, enjoining or preventing the consummation of the transactions contemplated hereby or in the other Transaction Agreements.
6.2 Conditions to the Obligation of the Company. The obligation of the Company to consummate the transactions to be consummated at the Closing, and to issue and sell to the Investor the Common Stock to be purchased by it at the Closing pursuant to this Agreement, is subject to the satisfaction or waiver in writing of the following conditions precedent:
(a) Representations and Warranties. The representations and warranties of the Investor in Section 4 hereto shall be true and correct on and as of the Closing Date, with the same force and effect as though made on and as of the Closing Date and consummation of the Closing shall constitute a reaffirmation by the Investor of each of the representations, warranties, covenants and agreements of the Investor contained in this Agreement as of the Closing Date.
(b) Performance. The Investor shall have performed or complied with in all material respects all obligations and conditions herein required to be performed or observed by the Investor on or prior to the Closing Date.
(c) Injunction. The purchase of and payment for the Shares by the Investor shall not be prohibited or enjoined by any law or governmental or court order or regulation.
(d) Registration Rights Agreement. The Investor shall have executed and delivered the Registration Rights Agreement to the Company in the form attached as Exhibit A.
(e) Payment. The Company shall have received payment, by wire transfer of immediately available funds, in the full amount of the purchase price for the number of Shares being purchased by the Investor at the Closing pursuant to Section 2.
7. Termination.
7.1 Termination. The obligations of the Company, on the one hand, and the Investor, on the other hand, to effect the Closing shall terminate as follows:
(i) Upon the mutual written consent of the Company and the Investor prior to the Closing;
(ii) By the Company if any of the conditions set forth in Section 6.2 shall have become incapable of fulfillment, and shall not have been waived by the Company;
(iii) By the Investor if any of the conditions set forth in Section 6.1 shall have become incapable of fulfillment, and shall not have been waived by the Investor; or
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(iv) By either the Company or the Investor if the Closing has not occurred on or prior to the date that is ten (10) Business Days after the date of this Agreement;
provided, however, that, except in the case of clauses (ii) and (iii) above, the party seeking to terminate its obligation to effect the Closing shall not then be in breach of any of its representations, warranties, covenants or agreements contained in the Transaction Agreements if such breach has resulted in the circumstances giving rise to such party’s seeking to terminate its obligation to effect the Closing.
7.2 Notice. In the event of termination by the Company or the Investor of its obligations to effect the Closing pursuant to Section 7.1, written notice thereof shall be given to the other party. Nothing in this Section 7 shall be deemed to release any party from any liability for any breach by such party of the other terms and provisions of the Transaction Agreements or to impair the right of any party to compel specific performance by any other party of its other obligations under the Transaction Agreements.
7.3 Termination Upon Acquisition Transaction. Notwithstanding anything to the contrary in this Agreement, upon the consummation of an Acquisition Transaction, the obligations of the parties under this Agreement shall automatically terminate and the Transaction Agreements shall be deemed terminated in their entirety except that the provisions of Section 5.10, Section 8 and, to the extent applicable to the foregoing, Section 1,shall survive such termination.
8. Miscellaneous Provisions.
8.1 Public Statements or Releases. The Company and the Investor agree that their respective initial press releases to be issued with respect to the transactions contemplated by this Agreement shall be in the form heretofore agreed to by the parties. Except as set forth in Section 5.3, neither the Company nor the Investor shall make any public announcement that is inconsistent with such press releases or the Disclosure Documents without the prior consent of the other party (which consent shall not be unreasonably withheld). Notwithstanding the foregoing, and subject to compliance with Section 5.3, nothing in this Section 8.1 shall prevent any party from making any public announcement it considers necessary in order to satisfy its obligations under the law, including applicable securities laws, or under the rules of any national securities exchange or securities market, in which case the Company shall allow the Investor reasonable time to comment on such release or announcement in advance of such issuance (and the Company shall consider such comments in good faith).
8.2 Interpretation. The words “hereof,” “herein” and “hereunder” and words of similar import when used in this Agreement will refer to this Agreement as a whole and not to any particular provision of this Agreement, and section and subsection references are to this Agreement unless otherwise specified. The headings in this Agreement are included for convenience of reference only and will not limit or otherwise affect the meaning or interpretation of this Agreement. Whenever the words “include,” “includes” or “including” are used in this Agreement, they will be deemed to be followed by the words “without limitation.” The phrases “the date of this Agreement,” “the date hereof” and terms of similar import, unless the context otherwise requires, will be deemed to refer to the date set forth in the first paragraph of this Agreement. The meanings given to terms defined herein will be equally applicable to both the singular and plural
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forms of such terms. All matters to be agreed to by any party hereto must be agreed to in writing by such party unless otherwise indicated herein. References to agreements, policies, standards, guidelines or instruments, or to statutes or regulations, are to such agreements, policies, standards, guidelines or instruments, or statutes or regulations, as amended or supplemented from time to time (or to successors thereto).
8.3 Notices. Any notices or other communications required or permitted to be given hereunder shall be in writing and shall be deemed to be given (a) when delivered if personally delivered to the party for whom it is intended, (b) when delivered, if sent by electronic mail during normal business hours of the recipient, and if not sent during normal business hours, then on the recipient’s next Business Day, or (c) one (1) Business Day after deposit with a nationally recognized overnight courier, freight prepaid, specifying next business day delivery, with written verification of receipt:
(a) If to the Company, addressed as follows:
Summit Therapeutics Inc.
601 Brickell Key Drive, Suite 1000
Miami, FL 33131
Attention: Chief Legal Officer
Email: [ ]
with a copy (which shall not constitute notice):
Baker & Hostetler LLP
45 Rockefeller Plaza
New York, NY 10111
Attention: Adam W. Finerman
Email: afinerman@bakerlaw.com
(b) If to the Investor, addressed as follows:
AstraZeneca Holdings B.V.
Prinses Beatrixlaan 5822595 BM
The Hague, the Netherlands
Attention: [ ]
Email: [ ]
with a copy (which shall not constitute notice):
Freshfields US LLP
3 World Trade Center
175 Greenwich Street
New York, NY 10007
Attention: Oliver J. Board
Email: oliver.board@freshfields.com
and
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Freshfields LLP
100 Bishopsgate
London EC2P 2S
United Kingdom
Attention: Julian G. Long; Jennifer Bethlehem
Email: [ ]
Any Person may change the address to which notices and communications to it are to be addressed by notification as provided for herein.
8.4 Consent to Electronic Notice. The Investor consents to the delivery of any stockholder notice pursuant to the Delaware General Corporation Law (the “DGCL”), as amended or superseded from time to time, by electronic mail pursuant to Section 232 of the DGCL (or any successor thereto) at the e-mail address set forth in Section 8.3(b), as updated from time to time by notice to the Company. To the extent that any notice given by means of electronic mail is returned or undeliverable for any reason, the foregoing consent shall be deemed to have been revoked until a new or corrected e-mail address has been provided, and such attempted electronic notice shall be ineffective and deemed to not have been given. Each party agrees to promptly notify the other parties of any change in its e-mail address, and that failure to do so shall not affect the foregoing.
8.5 Severability. If any part or provision of this Agreement is held unenforceable or in conflict with the applicable laws or regulations of any jurisdiction, the invalid or unenforceable part or provisions shall be replaced with a provision which accomplishes, to the extent possible, the original business purpose of such part or provision in a valid and enforceable manner, and the remainder of this Agreement shall remain binding upon the parties hereto.
8.6 Governing Law; Submission to Jurisdiction; Venue; Waiver of Trial by Jury.
(a) This Agreement shall be governed by, and construed in accordance with, the laws of the State of Delaware without regard to choice of laws or conflicts of laws provisions thereof that would require the application of the laws of any other jurisdiction.
(b) The Company and the Investor hereby irrevocably and unconditionally:
(i) submits for itself and its property in any legal action or proceeding relating solely to this Agreement or the transactions contemplated hereby, to the exclusive jurisdiction of the Delaware Court of Chancery and any state appellate court therefrom within the State of Delaware (or, solely if the Delaware Court of Chancery declines to accept jurisdiction over a particular matter, any state or federal court within the State of Delaware);
(ii) consents that any such action or proceeding may be brought in such courts, and waives any objection that it may now or hereafter have to the venue of any such action or proceeding in any such court or that such action or proceeding was brought in an inconvenient court and agrees not to plead or claim the same to the extent permitted by applicable law;
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(iii) agrees that service of process in any such action or proceeding may be effected by mailing a copy thereof by registered or certified mail (or any substantially similar form of mail), postage prepaid, to the party, as the case may be, at its address set forth in Section 8.3 or at such other address of which the other party shall have been notified pursuant thereto;
(iv) agrees that nothing herein shall affect the right to effect service of process in any other manner permitted by law or shall limit the right to sue in any other jurisdiction for recognition and enforcement of any judgment or if jurisdiction in the courts referenced in the foregoing clause (i) are not available despite the intentions of the parties hereto;
(v) agrees that final judgment in any such suit, action or proceeding brought in such a court may be enforced in the courts of any jurisdiction to which such party is subject by a suit upon such judgment, provided that service of process is effected upon such party in the manner specified herein or as otherwise permitted by law;
(vi) agrees that to the extent that such party has or hereafter may acquire any immunity from jurisdiction of any court or from any legal process with respect to itself or its property, such party hereby irrevocably waives such immunity in respect of its obligations under this Agreement, to the extent permitted by law; and
(vii) irrevocably and unconditionally waives trial by jury in any legal action or proceeding in relation to this Agreement.
8.7 Waiver. No waiver of any term, provision or condition of this Agreement, whether by conduct or otherwise, in any one or more instances, shall be deemed to be, or be construed as, a further or continuing waiver of any such term, provision or condition or as a waiver of any other term, provision or condition of this Agreement.
8.8 Expenses. Except as expressly set forth in the Transaction Agreements to the contrary, each party shall pay its own out-of-pocket fees and expenses, including the fees and expenses of attorneys, accountants and consultants employed by such party, incurred in connection with the proposed investment in the Shares and the consummation of the transactions contemplated thereby; provided, however, that the Company shall pay all Transfer Agent fees (including, without limitation, any fees required for same-day processing of any instruction letter delivered by the Company), stamp taxes and other taxes (other than income taxes) and duties levied in connection with the delivery of any Shares to the Investor.
8.9 Assignment. None of the parties may assign its rights or obligations under this Agreement or designate another person (i) to perform all or part of its obligations under this Agreement or (ii) to have all or part of its rights and benefits under this Agreement, in each case without the prior written consent of (x) the Company, in the case of the Investor, and (y) the Investor, in the case of the Company, provided that the Investor may, without the prior consent of the Company, assign its rights or obligations hereunder, in whole or in part, to any of its Affiliates (provided each such assignee agrees to be bound by the terms of this Agreement and makes the same representations and warranties set forth in Section 4 hereof). In the event of any assignment in accordance with the terms of this Agreement, the assignee shall specifically assume and be bound by the provisions of this Agreement by executing a writing agreeing to be bound by and
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subject to the provisions of this Agreement and shall deliver an executed counterpart signature page to this Agreement and, notwithstanding such assumption or agreement to be bound hereby by an assignee, no such assignment shall relieve any party assigning any interest hereunder from its obligations or liability pursuant to this Agreement.
8.10 Confidential Information.
(a) The Investor covenants that until such time as the transactions contemplated by this Agreement and any non-public information provided to the Investor are publicly disclosed by the Company, the Investor will maintain the confidentiality of all disclosures made to it in connection with this transaction (including the existence and terms of this transaction), other than to the Investor’s outside attorney, accountant, auditor or investment advisor only to the extent necessary to permit evaluation of the investment, and the performance of the necessary or required tax, accounting, financial, legal, or administrative tasks and services and other than as may be required by law.
(b) The Company may request from the Investor such reasonable and customary additional information as the Company may deem necessary to evaluate the eligibility of the Investor to acquire the Shares, and the Investor shall promptly provide such information as may reasonably be requested to the extent readily available; provided, that the Company agrees to keep any such information provided by the Investor confidential, except (i) as required by the federal securities laws, rules or regulations and (ii) to the extent such disclosure is required by other laws, rules or regulations, at the request of the staff of the SEC or regulatory agency or under the regulations of Nasdaq. The Investor acknowledges that the Company may file a copy of this Agreement and the Registration Rights Agreement with the SEC as an exhibit to a periodic report or a registration statement of the Company.
8.11 Third Parties. Nothing in this Agreement, express or implied, is intended to confer on any Person other than the parties to this Agreement any rights, remedies, claims, benefits, obligations or liabilities under or by reason of this Agreement, and no Person that is not a party to this Agreement (including, without limitation, any partner, member, shareholder, director, officer, employee or other beneficial owner of any party to this Agreement, in its own capacity as such or in bringing a derivative action on behalf of a party to this Agreement) shall have any standing as a third party beneficiary with respect to this Agreement or the transactions contemplated hereby.
8.12 No Legal Advice. The Company acknowledges and the Investor confirms that it has independently participated in the negotiation of the transaction contemplated hereby with the advice of its own counsel and advisors. The Investor also acknowledges that Baker & Hostetler LLP has not rendered legal advice to the Investor.
8.13 Headings. The titles, subtitles and headings in this Agreement are for convenience of reference and shall not form part of, or affect the interpretation of, this Agreement.
8.14 Counterparts. This Agreement may be executed in two or more identical counterparts, all of which shall be considered one and the same agreement and shall become effective when counterparts have been signed by each party and delivered to the other party; provided that a facsimile or pdf signature including any electronic signatures complying with the U.S. federal ESIGN Act of 2000, e.g., www.docusign.com shall be considered due execution and shall be binding upon the signatory thereto with the same force and effect as if the signature were an original, not a facsimile or pdf (or other electronic reproduction of a) signature.
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8.15 Entire Agreement; Amendments. This Agreement and the other Transaction Agreements (including all schedules and exhibits hereto and thereto) constitute the entire agreement between the parties hereto respecting the subject matter hereof and supersedes all prior agreements, negotiations, understandings, representations and statements respecting the subject matter hereof, whether written or oral. No amendment, modification, alteration, or change in any of the terms of this Agreement shall be valid or binding upon the parties hereto unless made in writing and duly executed by the Company and the Investor. The Company, on the one hand, and the Investor, on the other hand, may by an instrument signed in writing by such parties waive the performance, compliance or satisfaction by the Investor or the Company, respectively, with any term or provision hereof or any condition hereto to be performed, complied with or satisfied by the Investor or the Company, respectively.
8.16 Survival. The covenants, representations and warranties made by each party hereto contained in this Agreement shall survive the Closing and the delivery of the Shares in accordance with their respective terms. The Investor shall be responsible only for its own representations, warranties, agreements and covenants hereunder.
8.17 Mutual Drafting. This Agreement is the joint product of the Investor and the Company and each provision hereof has been subject to the mutual consultation, negotiation and agreement of such parties and shall not be construed for or against any party hereto.
8.18 Arm’s Length Negotiations. For the avoidance of doubt, the parties acknowledge and confirm that the terms and conditions of the Shares were determined as a result of arm’s-length negotiations.
8.19 Further Assurances. Each party shall do and perform, or cause to be done and performed, all such further acts and things, and shall execute and deliver all such other agreements, certificates, instruments and documents as the other party may reasonably request in order to carry out the intent and accomplish the purposes of this Agreement and the consummation of the transactions contemplated hereby.
8.20 No Recourse. This Agreement may only be enforced against, and any claim, action, suit, or other legal proceeding based upon, arising out of, or related to this Agreement, any representation or warranty contained herein, any certificate delivered hereunder, or the negotiation, execution or performance of this Agreement, may only be brought against the entities that are expressly named as parties hereto. No past, present, or future director, officer, employee, incorporator, manager, member, partner, stockholder, Affiliate, agent, attorney, or other representative of any party hereto or of any Affiliate of any party hereto, or any of their successors or permitted assigns (collectively, the “Non-Party Affiliates”), shall have any liability for any obligations or liabilities of any party hereto under this Agreement or for any claim, action, suit, or other legal proceeding based on, in respect of or by reason of the transactions contemplated hereby, except for claims for Fraud. This Section 8.20 is intended for the benefit of, and shall be enforceable by, each of the Non-Party Affiliates. As used herein, “Fraud” means, with respect to
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a Person, an actual and intentional misrepresentation of a material existing fact with respect to the making of any representation or warranty in Section 3 for the purpose of inducing the other party to act, and upon which the other party justifiably relies with resulting losses. For the avoidance of doubt, Fraud shall not include any claim for equitable fraud, constructive fraud, promissory fraud, unfair dealings fraud, fraud by reckless or negligent misrepresentations or any tort based on negligence or recklessness.
[Remainder of Page Intentionally Left Blank]
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IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year first above written.
| COMPANY: | ||
| SUMMIT THERAPEUTICS INC. | ||
| By: | /s/ Mahkam Zanganeh | |
| Name: Dr. Mahkam Zanganeh | ||
| Title: Co-Chief Executive Officer and President | ||
[Signature Page to Securities Purchase Agreement]
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year first above written.
| INVESTOR: | ||
| ASTRAZENECA HOLDINGS B.V. | ||
| By: | /s/ Adil Aboumajd | |
| Name: Adil Aboumajd | ||
| Title: Director | ||
[Signature Page to Securities Purchase Agreement]
EXHIBIT A
FORM OF REGISTRATION RIGHTS AGREEMENT
A-1
EXHIBIT B
FORM OF CERTIFICATE OF DESIGNATIONS
B-1
Exhibit 10.2
FORM OF
REGISTRATION RIGHTS AGREEMENT
THIS REGISTRATION RIGHTS AGREEMENT (this “Agreement”), dated as of [•], 2026, is entered into by and between Summit Therapeutics Inc., a Delaware corporation (the “Company”), and AstraZeneca Holdings B.V., a Dutch private limited liability company (together with its permitted assigns, the “Investor”). Capitalized terms used herein and not otherwise defined herein shall have the respective meanings set forth in the Securities Purchase Agreement by and among the parties hereto, dated as of the date hereof (as amended, restated, supplemented or otherwise modified from time to time, the “Purchase Agreement”).
WHEREAS:
A. Upon the terms and subject to the conditions of the Purchase Agreement, the Company has agreed to issue to the Investor, and the Investor has agreed to purchase, an aggregate of $2,000,000,000 of the Company’s non-voting convertible preferred stock (the “Convertible Preferred Stock”), convertible into shares of the Company’s common stock, par value $0.01 per share (the “Common Stock”), pursuant to the Purchase Agreement.
B. To induce the Investor to enter into the Purchase Agreement, the Company has agreed to provide certain registration rights under the U.S. Securities Act of 1933, as amended, and the rules and regulations thereunder, or any similar successor statute (collectively, the “Securities Act”), and applicable state securities laws.
NOW, THEREFORE, in consideration of the promises and the mutual covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Company and the Investor hereby agree as follows:
1. DEFINITIONS.
For purposes of this Agreement, the following terms shall have the following meanings:
(a) “Business Day” means any day except any Saturday, any Sunday, any day which is a federal legal holiday in the United States or any day on which banking institutions in the State of New York, Amsterdam, the Netherlands or London, United Kingdom are authorized or required by law or other governmental action to close.
(b) “Person” means any individual or entity including but not limited to any corporation, limited liability company, association, partnership, organization, business, individual, governmental or political subdivision thereof or a governmental agency.
(c) “Register,” “Registered,” and “Registration” refer to a registration effected by preparing and filing one or more registration statements of the Company in compliance with the Securities Act and providing for offering securities on a continuous basis, and the declaration or ordering of effectiveness of such registration statement(s) by the U.S. Securities and Exchange Commission (the “SEC”).
(d) “Registrable Securities” means (i) the maximum number of shares of Common Stock of the Company issued or issuable upon conversion of the Convertible Preferred Stock acquired by the Investor pursuant to the Purchase Agreement (such shares of Common Stock issued or issuable upon conversion of the Convertible Preferred Stock, the “Shares”) and (ii) any Common Stock issued or issuable with respect to the Shares as a result of any stock split or subdivision, stock dividend, recapitalization, exchange or similar event. Registrable Securities shall cease to be Registrable Securities upon the date on which the Investor shall have resold all the Registrable Securities covered by the Registration Statement.
(e) “Registration Expenses” means all registration and filing fee expenses incurred by the Company in effecting any registration pursuant to this Agreement, including (i) all registration, qualification, and filing fees, printing expenses, and any other fees and expenses associated with filings required to be made with the SEC, FINRA or any other regulatory authority, (ii) all fees and expenses in connection with compliance with or clearing the Registrable Securities for sale under any securities or “Blue Sky” laws, (iii) all printing, duplicating, word processing, messenger, telephone, facsimile and delivery expenses, and (iv) all fees and disbursements of counsel for the Company and of all independent certified public accountants of the Company (including the expenses of any special audit and cold comfort letters required by or incident to such performance).
(f) “Registration Statement” means any registration statement of the Company filed with, or to be filed with, the SEC under the Securities Act, that Registers Registrable Securities, including the related prospectus, amendments and supplements to such registration statement, including pre- and post-effective amendments, and all exhibits and all material incorporated by reference in such registration statement as may be necessary to comply with applicable securities laws. “Registration Statement” shall also include: (i) to the extent the Company is a well-known seasoned issuer (as defined in Rule 405) at a time when it is obligated to file a Registration Statement pursuant to this Agreement and at such time an existing automatic shelf registration statement (as defined in Rule 405) is effective, a prospectus supplement to such automatic shelf registration statement in accordance with the requirements of the Securities Act and the rules and regulations of the SEC thereunder that covers the Registrable Securities; and (ii) a New Registration Statement, as amended when each became effective, including all documents filed as part thereof or incorporated by reference therein, and including any information contained in a prospectus subsequently filed with the SEC.
(g) “Rule 405” means Rule 405 under the Securities Act, as such rule may be amended from time to time, or any similar rule or regulation hereafter adopted by the SEC.
(h) “Selling Expenses” means all underwriting discounts and selling commissions applicable to the sale of Registrable Securities and all similar fees and commissions relating to the Investor’s disposition of the Registrable Securities.
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2. REGISTRATION.
(a) Mandatory Registration. The Company shall, as promptly as reasonably practicable and in any event no later than [•]1, 2026 (the “Filing Deadline”), prepare and file with the SEC an initial Registration Statement (the “Initial Registration Statement”) covering the resale of all Registrable Securities. Before filing the Registration Statement, the Company shall furnish to the Investor a copy of the Registration Statement. The Investor and its counsel shall have at least three (3) Business Days prior to the anticipated filing date of a Registration Statement to review and comment upon such Registration Statement and any amendment or supplement to such Registration Statement and any related prospectus (including any documents incorporated by reference therein), prior to its filing with the SEC. The Company shall (a) use its reasonable best efforts to address in each such document prior to being so filed with the SEC such comments as the Investor or its counsel reasonably proposed by the Investor, and (b) not file any Registration Statement or related prospectus or any amendment or supplement thereto containing information regarding the Investor to which Investor reasonably objects, unless such information is required to comply with any applicable law or regulation. The Investor shall furnish all information reasonably requested by the Company and as shall be reasonably required in connection with any registration referred to in this Agreement.
(b) Effectiveness. The Company shall use its reasonable best efforts to have the Initial Registration Statement and any amendment declared effective by the SEC at the earliest possible date but no later than the earlier of the seventy-fifth (75th) calendar day following the initial filing date of the Initial Registration Statement if the SEC notifies the Company that it will “review” the Initial Registration Statement and (b) the fifth (5th) Business Day after the date the Company is notified (orally or in writing, whichever is earlier) by the SEC that the Initial Registration Statement will not be “reviewed” or will not be subject to further review (the “Effectiveness Deadline”). The Company shall notify the Investor by e-mail as promptly as practicable, and in any event, within twenty-four (24) hours, after the Registration Statement is declared effective or is supplemented and shall provide the Investor with copies of any related Prospectus to be used in connection with the sale or other disposition of the securities covered thereby. The Company shall use reasonable best efforts to keep the Initial Registration Statement continuously effective pursuant to Rule 415 promulgated under the Securities Act and available for the resale by the Investor of all of the Registrable Securities covered thereby at all times until the earliest to occur of the following events: (i) the date on which the Investor shall have resold all the Registrable Securities covered thereby; and (ii) the date on which the Registrable Securities may be resold by the Investor without registration and without regard to any volume or manner-of-sale limitations by reason of Rule 144, without the requirement for the Company to be in compliance with the current public information requirement under Rule 144 under the Securities Act or any other rule of similar effect (the “Registration Period”). The Initial Registration Statement (including any amendments or supplements thereto and prospectuses contained therein) shall not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein, or necessary to make the statements therein, in light of the circumstances in which they were made, not misleading.
| 1 | To be 60 days after the closing of the Investment. |
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(c) Sufficient Number of Shares Registered. In the event the number of shares available under the Initial Registration Statement at any time is insufficient to cover the Registrable Securities, the Company shall, to the extent necessary and permissible, amend the Initial Registration Statement or file a new registration statement (together with any prospectuses or prospectus supplements thereunder, a “New Registration Statement”), so as to cover all of such Registrable Securities as soon as reasonably practicable, but in any event not later than ten (10) Business Days after the necessity therefor arises (the “New Registration Filing Deadline”). The Company shall use its reasonable best efforts to have such amendment and/or New Registration Statement become effective as soon as reasonably practicable following the filing thereof but no later than the earlier of the seventy-fifth (75th) calendar day following the initial filing date of the New Registration Statement if the SEC notifies the Company that it will “review” the New Registration Statement and (b) the fifth (5th) Business Day after the date the Company is notified (orally or in writing, whichever is earlier) by the SEC that the New Registration Statement will not be “reviewed” or will not be subject to further review (the earlier of such dates, the “New Registration Effectiveness Deadline”). The provisions of Section 2(a) and (b) shall apply to the New Registration Statement, except as modified hereby.
(d) Liquidated Damages. If (i) the Initial Registration Statement has not been filed by the Filing Deadline, (ii) the Initial Registration Statement has not been declared effective by the Effectiveness Deadline, (iii) the New Registration Statement has not been filed by the New Registration Filing Deadline, (iv) the New Registration Statement has not been declared effective by the New Registration Effectiveness Deadline or (v) after any Registration Statement has been declared effective by the SEC, sales cannot be made pursuant to such Registration Statement for any reason (including without limitation by reason of a stop order, or the Company’s failure to update such Registration Statement), but excluding any Allowed Delay (as defined below) or, if the Registration Statement is on Form S-1, for a period of twenty (20) days following the date on which the Company files a post-effective amendment to incorporate the Company’s Annual Report on Form 10-K (a “Maintenance Failure”), then the Company will make payments to the Investor, as liquidated damages and not as a penalty, in an amount equal to 0.5% of the aggregate amount paid pursuant to the Purchase Agreement by the Investor for such Registrable Securities then held by the Investor for each 30-day period or pro rata for any portion thereof during which the failure continues (the “Blackout Period”). Such payments shall constitute the Investor’s exclusive monetary remedy for such events, but shall not affect the right of the Investor to seek injunctive relief. The amounts payable as liquidated damages pursuant to this paragraph shall be paid in cash no later than five (5) Business Days after each such 30-day period following the commencement of the Blackout Period until the termination of the Blackout Period (the “Blackout Period Payment Date”). Interest shall accrue at the rate of 0.5% per month on any such liquidated damages payments that shall not be paid by the Blackout Period Payment Date until such amount is paid in full. Notwithstanding the above, in no event shall the aggregate amount of liquidated damages (or interest thereon) paid under this Agreement to the Investor exceed, in the aggregate, 2.5% of the aggregate purchase price of the Shares purchased by the Investor under the Purchase Agreement. Notwithstanding anything in this Section 2(d) to the contrary, during any periods that the Company is unable to meet its obligations hereunder with respect to the registration of the Registrable Securities because the Investor fails to furnish information required to be provided pursuant to Section 2(a) or Section 4(a) within three (3) Business Days of the Company’s request, any liquidated damages that would otherwise accrue as to the Investor only shall be tolled until such information is delivered to the Company.
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(e) Allowable Delays. On no more than two occasions and for not more than sixty (60) consecutive days or for a total of not more than one hundred twenty (120) days in any twelve (12) month period, the Company may delay the effectiveness of the Initial Registration Statement or any other Registration Statement, or suspend the use of any prospectus included in any Registration Statement, in the event that the Company determines in good faith that such delay or suspension is necessary to (A) delay the disclosure of material non-public information concerning the Company, the disclosure of which at the time is not, in the good faith opinion of the Company, in the best interests of the Company or (B) amend or supplement the affected Registration Statement or the related Prospectus so that such Registration Statement or Prospectus shall not include an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein, in the case of the Prospectus in light of the circumstances under which they were made, not misleading (an “Allowed Delay”); provided, that the Company shall promptly (a) notify the Investor in writing of the commencement of an Allowed Delay, but shall not (without the prior written consent of the Investor) disclose to the Investor any material non-public information giving rise to an Allowed Delay, (b) advise the Investor in writing to cease all sales under the Registration Statement until the end of the Allowed Delay and (c) use commercially reasonable efforts to terminate an Allowed Delay as promptly as practicable.
(f) Rule 415; Cutback. If at any time the SEC takes the position that the offering of some or all of the Registrable Securities in any Registration Statement is not eligible to be made on a delayed or continuous basis under the provisions of Rule 415 under the Securities Act (provided, however, the Company shall be obligated to use reasonable best efforts to advocate with the SEC for the registration of all of the Registrable Securities) or requires any Investor to be named as an “underwriter,” the Company shall (i) promptly notify the Investor thereof and (ii) make commercially reasonable efforts to persuade the SEC that the offering contemplated by such Registration Statement is a valid secondary offering and not an offering “by or on behalf of the issuer” as defined in Rule 415 and that the Investor is not an “underwriter.” The Investor shall have the right to have its legal counsel, at such Investor’s expense, to review and oversee any registration or matters pursuant to this Section 2(f), including participation in any meetings or discussions with the SEC regarding the SEC’s position and to comment on any written submission made to the SEC with respect thereto. No such written submission with respect to this matter shall be made to the SEC to which the Investor’s counsel reasonably objects. In the event that, despite the Company’s reasonable best efforts and compliance with the terms of this Section 2(f) the SEC refuses to alter its position, the Company shall (i) remove from such Registration Statement such portion of the Registrable Securities (the “Cut Back Shares”) and/or (ii) agree to such restrictions and limitations on the registration and resale of the Registrable Securities as the SEC may require to assure the Company’s compliance with the requirements of Rule 415 (collectively, the “SEC Restrictions”); provided, however, that the Company shall not name the Investor as an “underwriter” in such Registration Statement without the prior written consent of the Investor (provided that, in the event an Investor withholds such consent, the Company shall have no obligation hereunder to include any Registrable Securities of the Investor in any Registration Statement covering the resale thereof until such time as the SEC no longer requires the Investor to be named as an “underwriter” in such Registration Statement or the Investor otherwise consents in writing to being so named). Any cut-back imposed on the Investor pursuant to this Section 2(f) shall be applied to the Registrable Securities of the Investor as the Investor shall designate, unless the SEC Restrictions otherwise require or provide or the Investor otherwise agrees. No liquidated
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damages shall accrue as to any Cut Back Shares until such date as the Company is able to effect the registration of such Cut Back Shares in accordance with any SEC Restrictions applicable to such Cut Back Shares (such date, the “Restriction Termination Date”). From and after the Restriction Termination Date applicable to any Cut Back Shares, all of the provisions of this Section 2 (including the Company’s obligations with respect to the filing of a Registration Statement and its obligations to use reasonable efforts to have such Registration Statement declared effective within the time periods set forth herein and the liquidated damages provisions relating thereto) shall again be applicable to such Cut Back Shares; provided, however, that the date by which the Company is required to file the Registration Statement with respect to such Cut Back Shares shall be the tenth (10th) day following the Restriction Termination Date and the date by which the Company is required to have the Registration Statement effective with respect to such Cut Back Shares shall be the fifty-fifth (55th) day immediately after the Restriction Termination Date.
3. RELATED COMPANY OBLIGATIONS.
With respect to the Registration Statement and whenever any Registrable Securities are to be Registered pursuant to Section 2 including on the Initial Registration Statement or on any New Registration Statement, the Company shall use its reasonable best efforts to effect the registration of the Registrable Securities in accordance with the intended method of disposition thereof and, pursuant thereto, the Company shall have the following obligations:
(a) Notifications. The Company will promptly notify the Investor promptly of the time when any subsequent amendment to the Initial Registration Statement or any New Registration Statement, other than documents incorporated by reference, has been filed with the SEC and/or has become effective or where a receipt has been issued therefor or any subsequent supplement to a prospectus has been filed and of any request by the SEC for any amendment or supplement to the Registration Statement, any New Registration Statement or any prospectus or for additional information.
(b) Amendments. The Company will prepare and file with the SEC any amendments, post-effective amendments or supplements to the Initial Registration Statement, any New Registration Statement or any related prospectus, as applicable, (a) as may be necessary to keep such Registration Statement effective for the Effectiveness Period and to comply with the provisions of the Securities Act and the Exchange Act with respect to the distribution of all of the Registrable Securities covered thereby, or (b) in the reasonable opinion of the Investor and the Company, as may be necessary or advisable in connection with any acquisition or sale of Registrable Securities by the Investor.
(c) Investor Review. The Company will not file any amendment or supplement to the Registration Statement, any New Registration Statement or any prospectus, other than documents incorporated by reference, relating to the Investor, the Registrable Securities or the transactions contemplated hereby unless (A) the Investor and its counsel shall have been advised and afforded the opportunity to review and comment thereon at least one (1) Business Day prior to filing with the SEC and (B) the Company shall have given reasonable due consideration to any comments thereon received from the Investor or its counsel.
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(d) Copies Available. The Company will furnish to the Investor and its counsel copies of the Initial Registration Statement, any prospectus thereunder (including all documents incorporated by reference therein), any prospectus supplement thereunder, any New Registration Statement and all amendments to the Initial Registration Statement or any New Registration Statement that are filed with the SEC during the Registration Period (including all documents filed with or furnished to the SEC during such period that are deemed to be incorporated by reference therein), each letter written by or on behalf of the Company to the SEC or the staff of the SEC, and each item of correspondence from the SEC or the staff of the SEC, in each case relating to such Registration Statement (other than any portion thereof which contains information for which the Company has sought confidential treatment) and such other documents as Investor may reasonably request in order to facilitate the disposition of the Registrable Securities owned by Investor that are covered by such Registration Statement, in each case as soon as reasonably practicable upon such Investor’s request and in such quantities as such Investor may from time to time reasonably request; provided, however, that the Company shall not be required to furnish any document to the Investor to the extent such document is available on EDGAR.
(e) Notification of Stop Orders; Material Changes. The Company shall use best efforts to (i) prevent the issuance of any stop order or other suspension of effectiveness and, (ii) if such order is issued, obtain the withdrawal of any such order as soon as practicable. The Company shall advise the Investor promptly (but in no event later than 24 hours) and shall confirm such advice in writing, in each case: (i) of the Company’s receipt of notice of any request by the SEC or any other federal or state governmental authority for amendment of or a supplement to the Registration Statement or any prospectus or for any additional information; (ii) of the Company’s receipt of notice of the issuance by the SEC or any other federal or state governmental authority of any stop order suspending the effectiveness of the Initial Registration Statement or prohibiting or suspending the use of any prospectus or prospectus supplement, or any New Registration Statement, or of the Company’s receipt of any notification of the suspension of qualification of the Registrable Securities for offering or sale in any jurisdiction or the initiation or contemplated initiation of any proceeding for such purpose; and (iii) of the Company becoming aware of the happening of any event, which makes any statement of a material fact made in any Registration Statement or any prospectus untrue or which requires the making of any additions to or changes to the statements then made in any Registration Statement or any prospectus in order to state a material fact required by the Securities Act to be stated therein or necessary in order to make the statements then made therein (in the case of any prospectus, in light of the circumstances under which they were made) not misleading, or of the necessity to amend any Registration Statement or any prospectus to comply with the Securities Act or any other law. The Company shall not be required to disclose to the Investor the substance of specific reasons of any of the events set forth in clause (i) to (iii) of the immediately preceding sentence (each, a “Suspension Event”), but rather, shall only be required to disclose that the event has occurred. If at any time the SEC, or any other federal or state governmental authority shall issue any stop order suspending the effectiveness of any Registration Statement or prohibiting or suspending the use of any prospectus or prospectus supplement, the Company shall use its reasonable best efforts to obtain the withdrawal of such order at the earliest practicable time. The Company shall furnish to the Investor, without charge, a copy of any correspondence from the SEC or the staff of the SEC, or any other federal or state governmental authority to the Company or its representatives relating to the Initial Registration Statement, any New Registration Statement or any prospectus, or prospectus supplement as the case may be. In the event of a Suspension Event set forth in clause
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(iii) of the first sentence of this Section 3(e), the Company will use its commercially reasonable efforts to publicly disclose such event as soon as reasonably practicable, or otherwise resolve the matter such that sales under Registration Statements may resume; provided, however, that if the Company has a bona fide business purpose for not making such information public, the Company may suspend the use of all Registration Statements for up to sixty (60) consecutive calendar days; provided, further, that the Company may not suspend the use of all Registration Statements more than twice, or for more than ninety (90) total calendar days, in each case during any twelve-month period.
(f) Confirmation of Effectiveness. If reasonably requested by the Investor at any time in respect of any Registration Statement, the Company shall deliver to the Investor a written confirmation from Company’s counsel of whether or not the effectiveness of such Registration Statement has lapsed at any time for any reason (including, without limitation, the issuance of a stop order) and whether or not such Registration Statement is currently effective and available to the Company for sale of Registrable Securities.
(g) Listing. The Company shall use best efforts to cause all Registrable Securities covered by a Registration Statement to be listed on the Nasdaq Global Market.
(h) Compliance. The Company shall otherwise use best efforts to comply with all applicable rules and regulations of the SEC under the Securities Act and the Securities Exchange Act of 1934, as amended (the “Exchange Act”), including, without limitation, Rule 172 under the Securities Act, file any final prospectus, including any supplement or amendment thereof, with the SEC pursuant to Rule 424 under the Securities Act, promptly inform the Investor in writing if, at any time during the Effectiveness Period, the Company does not satisfy the conditions specified in Rule 172 and, as a result thereof, the Investor is required to deliver a prospectus in connection with any disposition of Registrable Securities and take such other actions as may be reasonably necessary to facilitate the registration of the Registrable Securities hereunder, and make available to its security holders, as soon as reasonably practicable, but not later than the Availability Date (as defined below), an earnings statement covering a period of at least twelve (12) months, beginning after the effective date of each Registration Statement, which earnings statement shall satisfy the provisions of Section 11(a) of the Securities Act, including Rule 158 promulgated thereunder (for the purpose of this subsection 3(h), “Availability Date” means the forty-fifth (45th) day following the end of the fourth fiscal quarter that includes the effective date of such Registration Statement, except that, if such fourth fiscal quarter is the last quarter of the Company’s fiscal year, “Availability Date” means the ninetieth (90th) day after the end of such fourth fiscal quarter).
(i) Blue-Sky. The Company shall use best efforts to register or qualify or cooperate with the Investor and its counsel in connection with the registration or qualification of such Registrable Securities for the offer and sale under the securities or blue sky laws of such jurisdictions reasonably requested by the Investor; provided, however, that the Company shall not be required in connection therewith or as a condition thereto to (i) qualify to do business in any jurisdiction where it would not otherwise be required to qualify but for this Section 3(i), (ii) subject itself to general taxation in any jurisdiction where it would not otherwise be so subject but for this Section 3(i), or (iii) file a general consent to service of process in any such jurisdiction.
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(j) Rule 144. With a view to making available to the Investor the benefits of Rule 144 (or its successor rule) and any other rule or regulation of the SEC that may at any time permit the Investor to sell shares of Common Stock to the public without registration, the Company covenants and agrees to: (i) make and keep adequate current public information available, as those terms are understood and defined in Rule 144 until the earlier of (A) six (6) months after such date as all of the Registrable Securities may be sold without restriction by the holders thereof pursuant to Rule 144 or any other rule of similar effect or (B) such date as there are no longer Registrable Securities; (ii) file with the SEC in a timely manner all reports and other documents required of the Company under the Exchange Act; (iii) furnish electronically to the Investor upon request, as long as the Investor owns any Registrable Securities, (A) a written statement by the Company that it has complied with the reporting requirements of the Exchange Act, (B) a copy of or electronic access to the Company’s most recent Annual Report on Form 10-K or Quarterly Report on Form 10-Q, and (C) such other information as may be reasonably requested in order to avail the Investor of any rule or regulation of the SEC that permits the selling of any such Registrable Securities without registration; and (iv) provide any legal opinions.
(k) Cooperation. The Company shall cooperate with the holder of the Registrable Securities to facilitate the timely preparation and delivery of certificates or uncertificated shares representing the Registrable Securities to be sold pursuant to such Registration Statement or Rule 144 free of any restrictive legends and representing such number of shares of Common Stock and registered in such names as the holders of the Registrable Securities may reasonably request to the extent permitted by such Registration Statement or Rule 144 to effect sales of Registrable Securities; for the avoidance of doubt, the Company may satisfy its obligations hereunder without issuing physical stock certificates through the use of The Depository Trust Company’s Direct Registration System.
(l) Removal of Restrictive Legends. The Company shall use reasonable best efforts to cause the Company’s transfer agent to remove any restrictive legend from any Registrable Securities, as promptly as practicable following such request.
4. OBLIGATIONS OF THE INVESTOR.
(a) Investor Information. The Investor shall provide a completed Investor Questionnaire in the form attached hereto as Exhibit A in connection with the registration of the Registrable Securities.
(b) Suspension of Sales. The Investor agrees that, upon receipt of any notice from the Company of the existence of a Suspension Event as set forth in Section 3(e), the Investor will immediately discontinue disposition of Registrable Securities pursuant to any Registration Statement covering such Registrable Securities until the Investor’s receipt of a notice from the Company confirming the resolution of such Suspension Event and that such dispositions may again be made.
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(c) Investor Cooperation. The Investor agrees to cooperate with the Company as reasonably requested by the Company in connection with the preparation and filing of any amendments and supplements to any Registration Statement or New Registration Statement hereunder, unless the Investor has notified the Company in writing of its election to exclude all of its Registrable Securities from such Registration Statement.
5. EXPENSES OF REGISTRATION.
All Registration Expenses incurred in connection with registrations pursuant to this Agreement shall be borne by the Company. All Selling Expenses relating to securities registered on behalf of the Investor shall be borne by the Investor.
6. INDEMNIFICATION.
(a) To the fullest extent permitted by law, the Company will, and hereby does, indemnify, hold harmless and defend the Investor, each Person, if any, who controls the Investor, the members, the directors, officers, partners, employees, members, managers, agents, representatives and advisors of the Investor and each Person, if any, who controls the Investor within the meaning of the Securities Act or the Exchange Act (each, an “Indemnified Person”), against any losses, obligation, claims, damages, liabilities, contingencies, judgments, fines, penalties, charges, costs (including, without limitation, court costs and costs of preparation, reasonable and documented attorneys’ fees, amounts paid in settlement (with the prior consent of the Company, such consent not to be unreasonably withheld, conditioned or delayed) or reasonable and documented expenses, (collectively, “Claims”)) reasonably incurred in investigating, preparing or defending any action, claim, suit, inquiry, proceeding, investigation or appeal taken from the foregoing by or before any court or governmental, administrative or other regulatory agency or body or the SEC, whether pending or threatened, whether or not an indemnified party is or may be a party thereto (“Indemnified Damages”), to which any of them may become subject insofar as such Claims (or actions or proceedings, whether commenced or threatened, in respect thereof) arise out of or are based upon: (i) any untrue statement or alleged untrue statement or omission or alleged omission of any material fact contained in any Registration Statement, any preliminary Prospectus or final Prospectus, or any amendment or supplement thereof, or (ii) any violation or alleged violation by the Company or any of its Subsidiaries of the Securities Act, Exchange Act or any other state securities or other “blue sky” laws of any jurisdiction in which Registrable Securities are offered or any rule or regulation promulgated thereunder applicable to the Company or its agents and relating to action or inaction required of the Company in connection with such registration of the Registrable Securities (the matters in the foregoing clauses (i) and (ii) being, collectively, “Violations”). The Company shall reimburse each Indemnified Person promptly as such expenses are incurred and are due and payable, for any reasonable out-of-pocket legal fees or other reasonable and documented expenses incurred by them in connection with investigating or defending any such Claim. Notwithstanding anything to the contrary contained herein, the indemnification agreement contained in this Section 6(a): (A) shall not apply to a Claim by an Indemnified Person arising out of or based upon a Violation which occurs in reliance upon and in conformity with information furnished in writing to the Company by the Investor or such Indemnified Person specifically for use in such Registration Statement or prospectus and was reviewed and approved in writing by such Investor or such Indemnified Person expressly for use in connection with the preparation of any Registration Statement, any prospectus or any such amendment thereof or supplement thereto, in each case if the foregoing was timely made available by the Company; (B) with respect to any superseded prospectus, shall not inure to the benefit of
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any such Person from whom the Person asserting any such Claim purchased the Registrable Securities that are the subject thereof (or to the benefit of any other Indemnified Person) if the untrue statement or omission of material fact contained in the superseded prospectus was corrected in the revised prospectus, as then amended or supplemented, and the Indemnified Person was promptly advised in writing not to use the outdated, defective or incorrect prospectus prior to the use giving rise to a violation; (C) shall not be available to the extent such Claim is based on a failure of the Investor to deliver, or cause to be delivered, if required the prospectus to the Persons asserting an untrue statement or omission or alleged untrue statement or omission at or prior to the written confirmation of the sale of Registrable Securities; and (D) shall not apply to amounts paid in settlement of any Claim if such settlement is effected without the prior written consent of the Company, which consent shall not be unreasonably withheld, conditioned or delayed. Such indemnity shall remain in full force and effect regardless of any investigation made by or on behalf of the Indemnified Person and shall survive the transfer of the Registrable Securities by the Investor pursuant to Section 8.
(b) In connection with the Initial Registration Statement, any New Registration Statement or any prospectus, the Investor agrees to indemnify, hold harmless and defend, the Company, each of its directors, each of its officers who signed the Initial Registration Statement or signs any New Registration Statement, each Person, if any, who controls the Company within the meaning of the Securities Act or the Exchange Act (collectively and together with an Indemnified Person, an “Indemnified Party”), against any losses, claims, damages, liabilities and expense (including reasonable attorney fees) resulting from any Violation, in each case to the extent, and only to the extent, that such Violation occurs in reliance upon and in conformity with information about the Investor furnished in writing by the Investor to the Company and reviewed and approved in writing by such Investor or such Indemnified Person expressly for use in connection with the preparation of the Registration Statement, any New Registration Statement, any prospectus or any such amendment thereof or supplement thereto. In no event shall the liability of Investor be greater in amount than the dollar amount of the proceeds (net of all expense paid by Investor in connection with any claim relating to this Section 6 and the amount of any damages Investor has otherwise been required to pay by reason of such untrue statement or omission) received by Investor upon the sale of the Registrable Securities included in such Registration Statement giving rise to such indemnification obligation. Such indemnity shall remain in full force and effect regardless of any investigation made by or on behalf of such Indemnified Party and shall survive the transfer of the Registrable Securities by any Investor pursuant to Section 8.
(c) Promptly after receipt by an Indemnified Person or Indemnified Party under this Section 6 of notice of the commencement of any action or proceeding (including any governmental action or proceeding) involving a Claim, such Indemnified Person or Indemnified Party shall, if a Claim in respect thereof is to be made against any indemnifying party under this Section 6, deliver to the indemnifying party a written notice of the commencement thereof, and the indemnifying party shall have the right to participate in, and, to the extent the indemnifying party so desires, jointly with any other indemnifying party similarly noticed, to assume control of the defense thereof with counsel mutually satisfactory to the indemnifying party and the Indemnified Person or the Indemnified Party, as the case may be, and upon such notice, the indemnifying party shall not be liable to the Indemnified Person or the Indemnified Party for any legal or other expenses subsequently incurred by the Indemnified Person or the Indemnified Party in connection with the defense thereof; provided, however, that an Indemnified Person or
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Indemnified Party (together with all other Indemnified Persons and Indemnified Parties that may be represented without conflict by one counsel) shall have the right to retain its own counsel with the reasonable fees and expenses to be paid by the indemnifying party, if, in the reasonable opinion of counsel retained by the indemnifying party, the representation by such counsel of the Indemnified Person or Indemnified Party and the indemnifying party would be inappropriate due to actual or potential differing interests between such Indemnified Person or Indemnified Party and any other party represented by such counsel in such proceeding. The Indemnified Party or Indemnified Person shall cooperate with the indemnifying party in connection with any negotiation or defense of any such action or claim by the indemnifying party and shall furnish to the indemnifying party all information reasonably available to the Indemnified Party or Indemnified Person which relates to such action or claim. The indemnifying party shall keep the Indemnified Party or Indemnified Person fully apprised as to the status of the defense or any settlement negotiations with respect thereto. No indemnifying party shall be liable for any settlement of any action, claim or proceeding effected without its written consent, provided, however, that the indemnifying party shall not unreasonably withhold, delay or condition its consent. No indemnifying party shall, without the consent of the Indemnified Party or Indemnified Person, consent to entry of any judgment or enter into any settlement or other compromise 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 or Indemnified Person in respect to or arising out 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 or Indemnified Person. Following indemnification as provided for hereunder, the indemnifying party shall be subrogated to all rights of the Indemnified Party or Indemnified Person with respect to all third parties, firms or corporations relating to the matter for which indemnification has been made. The failure to deliver written notice to the indemnifying party within a reasonable time of the commencement of any such action shall not relieve such indemnifying party of any liability to the Indemnified Person or Indemnified Party under this Section 6, except to the extent that the indemnifying party is prejudiced in its ability to defend such action.
(d) The indemnification required by this Section 6 shall be made by periodic payments of the amount thereof during the course of the investigation or defense, as and when bills are received or Indemnified Damages are incurred. Any Person receiving a payment pursuant to this Section 6 which person is later determined to not be entitled to such payment shall return such payment (including reimbursement of expenses) to the person making it.
(e) The indemnity agreements contained herein shall be in addition to (i) any cause of action or similar right of the Indemnified Party or Indemnified Person against the indemnifying party or others, and (ii) any liabilities the indemnifying party may be subject to pursuant to the law.
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7. CONTRIBUTION.
To the extent any indemnification by an indemnifying party is prohibited or limited by law, the indemnifying party agrees to make the maximum contribution with respect to any amounts for which it would otherwise be liable under Section 6 to the fullest extent permitted by law; provided, however, that: (i) no seller of Registrable Securities guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from any seller of Registrable Securities who was not guilty of fraudulent misrepresentation; and (ii) contribution by any seller of Registrable Securities shall be limited in amount to the net amount of proceeds (net of all expenses paid by such holder in connection with any claim relating to this Section 7 and the amount of any damages such holder has otherwise been required to pay by reason of such untrue or alleged untrue statement or omission or alleged omission) received by such seller from the sale of such Registrable Securities giving rise to such contribution obligation.
8. ASSIGNMENT OF REGISTRATION RIGHTS.
The Company shall not assign this Agreement or any rights or obligations hereunder (whether by operation of law or otherwise) without the prior written consent of the Investor; provided, however, that in any transaction, whether by merger, reorganization, restructuring, consolidation, financing or otherwise, whereby the Company is a party and in which the Registrable Securities are converted into the equity securities of another Person, from and after the effective time of such transaction, such Person shall, by virtue of such transaction, be deemed to have assumed the obligations of the Company hereunder, the term “Company” shall be deemed to refer to such Person and the term “Registrable Securities” shall be deemed to include the securities received by the Investor in connection with such transaction unless such securities are otherwise freely tradable by the Investor after giving effect to such transaction, and the prior written consent of the Investor shall not be required for such transaction. The Investor may not assign its rights under this Agreement, other than to an affiliate of the Investor, without the prior written consent of the Company. The provisions of this Agreement shall be binding upon and inure to the benefit of the Investor and its successors and permitted assigns.
9. AMENDMENTS AND WAIVERS.
The provisions of this Agreement, including the provisions of this sentence, may be amended, modified or supplemented, or waived only by a written instrument executed by (i) the Company and (ii) the Investor.
10. MISCELLANEOUS.
(a) Notices. Any notices or other communications required or permitted to be given hereunder shall be in writing and shall be deemed to be given (a) when delivered if personally delivered to the party for whom it is intended, (b) when delivered, if sent by electronic mail during normal business hours of the recipient, and if not sent during normal business hours, then on the recipient’s next business day, or (c) one (1) business day after deposit with a nationally recognized overnight courier, freight prepaid, specifying next business day delivery, with written verification of receipt:
(i) If to the Company, addressed as follows:
Summit Therapeutics Inc.
601 Brickell Key Drive, Suite 1000
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Miami, FL 33131
Attention: Chief Legal Officer
Email: [ ]
with a copy (which shall not constitute notice):
Baker & Hostetler LLP
45 Rockefeller Plaza
New York, NY 10111
Attention: Adam W. Finerman
Email: afinerman@bakerlaw.com
(ii) If to the Investor, at its e-mail address or address set forth in Section 8.3 of the Purchase Agreement or to such e-mail address, or address as subsequently modified by written notice given in accordance with this Section 10.
Any Person may change the address to which notices and communications to it are to be addressed by notification as provided for herein.
(b) No Waiver. No failure or delay on the part of either party hereto in the exercise of any power, right or privilege under this Agreement shall operate as a waiver thereof, nor shall any single or partial exercise of any such power, right or privilege preclude any other or further exercise thereof or of any other right, power or privilege.
(c) Governing Law. The provisions of Section 8.6 of the Purchase Agreement are incorporated by reference herein mutatis mutandis.
(d) Integration. This Agreement and the other Transaction Agreements (including all schedules and exhibits hereto and thereto) constitute the entire agreement between the parties hereto respecting the subject matter hereof and supersedes all prior agreements, negotiations, understandings, representations and statements respecting the subject matter hereof, whether written or oral.
(e) Headings. The titles, subtitles and headings in this Agreement are for convenience of reference and shall not form part of, or affect the interpretation of, this Agreement.
(f) Counterparts. This Agreement may be executed in two or more identical counterparts, all of which shall be considered one and the same agreement and shall become effective when counterparts have been signed by each party and delivered to the other party; provided that a facsimile or pdf signature including any electronic signatures complying with the U.S. federal ESIGN Act of 2000, e.g., www.docusign.com shall be considered due execution and shall be binding upon the signatory thereto with the same force and effect as if the signature were an original, not a facsimile or pdf (or other electronic reproduction of a) signature.
(g) Further Assurances. Each party shall do and perform, or cause to be done and performed, all such further acts and things, and shall execute and deliver all such other agreements, certificates, instruments and documents as the other party may reasonably request in order to carry out the intent and accomplish the purposes of this Agreement and the consummation of the transactions contemplated hereby.
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(h) Contract Interpretation. This Agreement is the joint product of the Investor and the Company and each provision hereof has been subject to the mutual consultation, negotiation and agreement of such parties and shall not be construed for or against any party hereto.
(i) No Third Party Beneficiaries. This Agreement is intended for the benefit of the parties hereto and their respective permitted successors and assigns, and is not for the benefit of, nor may any provision hereof be enforced by, any other Person. Nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties hereto or their respective successors and assigns any rights, remedies, obligations, or liabilities under or by reason of this Agreement, except as expressly provided in this Agreement.
(j) Severability. If any part or provision of this Agreement is held unenforceable or in conflict with the applicable laws or regulations of any jurisdiction, the invalid or unenforceable part or provisions shall be replaced with a provision which accomplishes, to the extent possible, the original business purpose of such part or provision in a valid and enforceable manner, and the remainder of this Agreement shall remain binding upon the parties hereto.
(k) Non-Recourse. Notwithstanding anything that may be expressed or implied in this Agreement, the Company covenants, agrees and acknowledges that no recourse under this Agreement or any documents or instruments delivered in connection with this Agreement shall be had against any current or future director, officer, employee, stockholder, general or limited partner or member of the Investor or of any affiliates or assignees thereof, whether by the enforcement of any assessment or by any legal or equitable proceeding, or by virtue of any statute, regulation or other applicable law, it being expressly agreed and acknowledged that no personal liability whatsoever shall attach to, be imposed on or otherwise be incurred by any current or future director, officer, employee, stockholder, general or limited partner or member of the Investor or of any affiliates or assignees thereof, as such for any obligation of the Investor under this Agreement or any documents or instruments delivered in connection with this Agreement for any claim based on, in respect of or by reason of such obligations or their creation.
(l) Cumulative Remedies. The remedies provided herein are cumulative and not exclusive of any remedies provided by law.
[Signature Page Follows]
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IN WITNESS WHEREOF, the parties have caused this Registration Rights Agreement to be duly executed as of date first written above.
| COMPANY: | ||
| SUMMIT THERAPEUTICS INC. | ||
| By: | ||
| Name: | ||
| Title: | ||
[Signature Page to Registration Rights Agreement]
IN WITNESS WHEREOF, the parties have caused this Registration Rights Agreement to be duly executed as of date first written above.
| INVESTOR: | ||
| ASTRAZENECA HOLDINGS B.V. | ||
| By: | ||
| Name: [•] | ||
| Title: [•] | ||
| Address: [•] | ||
| Email: [•] | ||
[Signature Page to Registration Rights Agreement]
Exhibit A
Investor Questionnaire
Exhibit 99.1
AstraZeneca Makes $2 Billion Strategic Equity Investment in Summit Therapeutics
Investment in Preferred Shares Convertible to Common Equity, Equivalent to a Per-Share Price of Summit’s Common Stock of $18.36, Representing a Premium over Today’s Closing Trading Price
Summit Also Enters into Clinical Trial Collaboration with AstraZeneca to Evaluate Ivonescimab in Combination with Sonesitatug Vedotin in Multiple Gastrointestinal Cancers
Summit & AstraZeneca Plan to Enter into a Clinical Trial Collaboration Combining Ivonescimab with Multiple AstraZeneca ADCs and Other Cancer Medicines
Miami, Florida, September 28, 2026 – Summit Therapeutics Inc. (Nasdaq: SMMT) today announced key developments important to the company’s progress towards achieving its goal of making a significant difference in the lives of patients with cancer. Specifically, Summit has established agreements with AstraZeneca (LSE/STO/NYSE: AZN) for a strategic equity investment in Summit and a clinical collaboration focused on ivonescimab and sonesitatug vedotin (sone-ve). Moreover, Summit and AstraZeneca intend to evaluate ivonescimab with an additional set of AstraZeneca’s cancer medicines, including other antibody drug conjugates (ADCs). Ivonescimab is a novel, potential first-in-class investigational PD-1 / VEGF bispecific antibody.
AstraZeneca Equity Investment in Summit
Summit and AstraZeneca have entered into an agreement whereby AstraZeneca will make an equity investment of $2.0 billion in convertible preferred shares. At the conversion ratio, the investment represents a common stock price equal to $18.36, representing a premium over today’s closing price.
“This significant investment, as well as the collaboration, is a powerful validation of the potential of ivonescimab,” said Robert W. Duggan, Chairman and Co-Chief Executive Officer of Summit Therapeutics. “We are proud to welcome AstraZeneca as a strategic investor as we continue to work with purposeful urgency to make a significant difference for patients with cancer by improving outcomes.”
Summit – AstraZeneca Clinical Trial Collaboration: Ivonescimab and Sone-Ve
Summit entered into a clinical collaboration agreement with AstraZeneca to evaluate sonesitatug vedotin in combination with ivonescimab with the intent to start studies in certain gastrointestinal (GI) cancer settings imminently. Sone-ve is a potential global first-in-class Claudin 18.2-targeting ADC with several ongoing trials underway in GI cancers.
Under the terms of the clinical collaboration agreement, each company will contribute their respective compound for the combination studies to be conducted, and the parties will jointly contribute to the costs of such studies, which are intended to be sponsored by AstraZeneca. Each company will retain development and commercial rights to their respective molecules.
“The developments announced today with AstraZeneca open an exciting new chapter in the advancement of ivonescimab,” said Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit Therapeutics. “With a growing body of evidence supporting ivonescimab’s differentiated PD-1 / VEGF bispecific approach, we look
forward to further broadening the development plan of ivonescimab and initiating new clinical trials exploring the potential to combine ivonescimab with promising novel anti-cancer compounds, including ADCs, to bring together complementary approaches to tumor-cell killing, antitumor immunity, and the tumor microenvironment.”
AstraZeneca recently reported positive high-level results from the CLARITY-Gastric01 trial for sone-ve in 2nd and later-line Claudin18.2-positive advanced gastric cancers demonstrating a statistically significant and clinically meaningful improvement in overall survival (OS) versus investigator’s choice of therapy. Results from this trial will be presented at the European Society for Medical Oncology Congress 2026 in a Presidential Symposium alongside the HARMONi-GI1 trial, an Akeso-sponsored trial from China in which ivonescimab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS vs. durvalumab plus chemotherapy in first-line advanced biliary tract cancer.
Planned Summit – AstraZeneca Clinical Trial Collaboration: Ivonescimab and AZ’s Cancer Medicines
Finally, Summit and AstraZeneca have executed a non-binding Memorandum of Understanding whereby the two companies intend to enter into an agreement to conduct clinical trials combining ivonescimab with multiple AstraZeneca’s cancer medicines, including its leading portfolio of ADCs. The companies intend to share clinical development costs of potential future studies. Each company will retain their current development and commercial rights to their respective molecules, and the agreement is mutually non-exclusive. There are no additional financial considerations associated with milestones, royalties, revenue-sharing, or profit-sharing.
“A core pillar of our oncology strategy is to broaden the reach of our ADC portfolio as the backbone of treatment across tumor types with combinations alongside next-generation immunotherapies,” said Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca. “Bispecifics targeting PD-1 and VEGF are rapidly advancing in development and have the potential to improve on current immunotherapies, particularly in lung, breast and gastrointestinal cancers. This opportunity to combine ivonescimab with AstraZeneca’s ADC portfolio, including with sone-ve, could enable new regimens that raise the bar for patients with cancer across the treatment landscape.”
The Memorandum of Understanding with respect to the potential clinical trial collaboration between Summit and AstraZeneca is non-binding, and there can be no assurances that the intended clinical trial collaboration comes to fruition.
Financial Terms of AstraZeneca Equity Investment
Under the terms of the Share Purchase Agreement entered into by Summit and AstraZeneca, AstraZeneca will purchase an aggregate of approximately 108,955 shares of preferred stock convertible into shares of common stock of Summit at a 1:1,000 ratio. The total investment by AstraZeneca will be $2.0 billion. At the conversion ratio, the investment represents a common stock price equal to $18.36, the volume weighted-average price (VWAP) for the five trading days from the prior week plus 10%. Closing of the transaction is subject to customary conditions and is expected to occur by the end of this week.
The securities described above have not been registered under the Securities Act of 1933, as amended. Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. Summit has agreed to file a registration statement with the Securities and Exchange Commission (SEC) registering the resale of the shares of common stock following the closing of the securities purchase agreement.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
About Ivonescimab
Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF.
This design is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Summit believes ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, iScience, 2025). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, iScience, 2025) increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets.
Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 5,000 patients have been treated with ivonescimab in clinical studies globally, and over 100,000 patients when considering those treated in a commercial setting in China, as noted by Akeso.
There are currently 16 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, five of which are Summit-sponsored global studies, one of which is a multiregional study sponsored by a cooperative group, and 10 of which are being or have been conducted in China by Akeso. Summit began its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In 2025, Summit began enrolling patients in HARMONi-7. Summit expanded its Phase III clinical development program into colorectal cancer (CRC) in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3. In 2026, Summit announced initiation of HARMONi-GU1, a Phase II/III study in urothelial carcinoma (bladder cancer) with global clinical trial site activations planned to begin by the fourth quarter of 2026.
HARMONi is a Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a third-generation EGFR TKI (e.g., osimertinib). Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026.
HARMONi-3 is a Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non-squamous NSCLC, irrespective of PD-L1 expression. The clinical trial is evaluating the two histologies as individual, separately powered cohorts with independent statistical powering.
HARMONi-7 is a Phase III clinical trial evaluating ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.
HARMONi-GI3 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy in patients with first-line unresectable metastatic CRC.
HARMONi-GU1 is a Phase II/III clinical trial evaluating ivonescimab plus the antibody drug conjugate (ADC) enfortumab vedotin (EV) compared to pembrolizumab plus EV as first-line therapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC).
ILLUMINE is a Phase III study being conducted by GORTEC, a cooperative group dedicated to Head and Neck Oncology, in recurrent / metastatic head and neck squamous cell carcinoma (r/m HNSCC). ILLUMINE is a three-arm Phase III clinical trial designed to evaluate ivonescimab monotherapy, as well as ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, compared to monotherapy pembrolizumab in patients with PD-L1 positive r/m HNSCC.
Five Phase III ivonescimab clinical trials have read out to date, all five with positive data. Four of these five studies are in NSCLC, and one is in biliary tract cancer (BTC). In addition to Summit’s positive HARMONi study, Akeso has had positive read-outs in three single-region (China), randomized Phase III clinical trials, HARMONi-A, HARMONi-2, and HARMONi-6, for ivonescimab in NSCLC, including a statistically significant overall survival benefit in all three studies from China. Akeso has also reported a statistically significant OS benefit in the single-region (China), randomized Phase III HARMONi-GI1 trial in advanced BTC.
HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.
HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression.
HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression.
HARMONi-GI1 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with durvalumab plus chemotherapy as a first-line treatment for patients with advanced BTC.
Akeso is actively conducting additional Phase III clinical studies in settings outside of NSCLC and biliary-tract cancer, including triple-negative breast cancer, head and neck squamous cell carcinoma, small cell lung cancer, colorectal cancer, and pancreatic cancer.
Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024.
About Summit Therapeutics Inc.
Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs.
Summit was founded in 2003 and the company’s shares are listed on the Nasdaq Global Market (symbol “SMMT”). Summit is headquartered in Miami, Florida, with additional offices in Palo Alto, California, Princeton, New Jersey, Dublin, Ireland, and Oxford, UK.
For more information, please visit https://www.smmttx.com and follow Summit on X @SMMT_TX.
Summit Forward-Looking Statements
Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the risk that the private placement does not close on the anticipated timeline or at all, including because required regulatory clearances are not obtained or other closing conditions are not satisfied, dilution to existing stockholders, and potential adverse effects on the market price of the Company’s common stock, including from future sales by AstraZeneca, the Company’s broad discretion over the use of proceeds, and the possibility that the proceeds will not be sufficient to fund operations as long as anticipated, AstraZeneca’s ownership and contractual rights, including Third Party acquisition participation, and registration rights, and potential conflicts of interest, the completion of the Private Placement does not depend on the parties entering into a definitive collaboration agreement, the Company’s reliance on AstraZeneca for the supply of AstraZeneca’s products and other contributions to the clinical trials, the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc. and other collaborations, the intended use of the net proceeds from the private placements, the Company’s anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, the expected timing of BLA submissions or FDA decisions, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program (“ATM Program”), the expected proceeds and uses thereof, the Company’s estimates regarding stock-based compensation, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to sell shares of our common stock under the ATM Program, the conditions affecting the capital markets, general economic, industry, or political conditions, including the effects of geopolitical developments, domestic and foreign trade policies, and
monetary policies, the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of filings that the Company makes with the Securities and Exchange Commission. Summit defines a “positive study” as a clinical study with one or more prespecified primary endpoints in which one of those endpoints achieves a statistically significant benefit according to the protocol or statistical analysis plan. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.
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Summit Therapeutics’ Media & Investor Contacts:
Nathan LiaBraaten
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Tracy Jones
Director, Media & Public Relations
investors@smmttx.com
media@smmttx.com