AGIOS PHARMACEUTICALS, INC. 10-Q

Item 5. Other Information (a) License Agreement with Alnylam On July 28, 2023, we entered into a license agreement, or the License Agreement, with Alnylam for the development and commercialization of products containing or comprised of an siRNA development candidate discovered by Alnylam and targeting the TMPRSS6 gene, which we refer to as the Licensed Products. We intend to pursue development of a Licensed Product for the potential treatment of patients with polycythemia vera. Pursuant to the License Agreement, subject to the rights retained by Alnylam thereunder, we obtained a worldwide, exclusive license to certain of Alnylam’s intellectual property rights to develop, manufacture and commercialize Licensed Products in all therapeutic uses in humans, excluding diseases of the central nervous system and eye, or the Field. We will be solely responsible for the development and commercialization of Licensed Products in the Field and all costs associated therewith. Alnylam will provide manufacturing support, at our expense, for the first phase 1 study for a Licensed Product, after which we will assume full responsibility for manufacturing. During the term of the License Agreement, each party and its affiliates are prohibited from, directly or indirectly, researching, developing, manufacturing or commercializing any siRNA product directed to TMPRSS6 in the Field, other than pursuant to the License Agreement, subject to certain exceptions in the event of a change of control. Under the terms of the License Agreement, we are obligated to pay Alnylam an upfront payment of $17.5 million. Alnylam is entitled to receive up to $130.0 million in development and regulatory milestone payments in addition to sales milestones and tiered royalties at percentages ranging from mid-single digits to mid-teens on annual net sales, if any, of Licensed Products, which may be subject to specified reductions and offsets. Unless earlier terminated, the License Agreement will expire upon the expiration of the last royalty term for the last Licensed Product in the Field. We may terminate the License Agreement in its entirety at any time upon 90 days’ prior written notice. Either party may, subject to specified cure periods, terminate the License Agreement in the event of the other party’s uncured material breach, and either party may terminate the License Agreement under specified circumstances relating to the other party’s insolvency. Alnylam has the right to terminate the License Agreement, subject to specified notice periods, if we or our affiliates or sublicensees challenges the validity or enforceability of certain Alnylam patent rights. The License Agreement contains other customary terms and conditions, including representations and warranties, covenants and indemnification obligations in favor of each party. (c) Director and Officer Trading Arrangements None of our directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K) during the quarterly period covered by this report. 57 Table of Contents Item 6. Exhibits Incorporated by Reference Exhibit Number Description of Exhibit Form File Number Date of Filing Exhibit Number Filed Herewith 3.1 Restated Certificate of Incorporation 8-K 001-36014 July 30, 2013 3.1 3.2 Third Amended and Restated By-Laws 8-K 001-36014 March 3, 2023 3.1 10.1# 2023 Stock Incentive Plan S-8 333-272615 June 13, 2023 99.1 10.2# Form of Stock Option Agreement Under 2023 Stock Incentive Plan X 10.3# Form of Restricted Stock Unit Agreement Under 2023 Stock Incentive Plan X 10.4# Form of Restricted Stock Unit Agreement (Performance-Based) Under 2023 Stock Incentive Plan X 31.1 Certification of principal executive officer pursuant to Rule 13a 14(a)/15d 14(a) of the Securities Exchange Act of 1934, as amended . X 31.2 Certification of principal financial officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended. X 32.1* Certification of principal executive officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. X 32.2* Certification of principal financial officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. X 101.INS XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are not embedded within the Inline XBRL document X 101.SCH XBRL Taxonomy Extension Schema Document X 101.CAL XBRL Taxonomy Calculation Linkbase Document X 101.DEF XBRL Taxonomy Extension Definition Linkbase Document X 101.LAB XBRL Taxonomy Label Linkbase Document X 101.PRE XBRL Taxonomy Presentation Linkbase Document X 104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101.INS) X * This certification will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liability of that section. Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent specifically incorporated by reference into such filing. # Indicates management contract or compensatory plan or arrangement. 58 Table of Contents SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. AGIOS PHARMACEUTICALS, INC. August 3, 2023 By: /s/ Brian Goff Brian Goff Chief Executive Officer (principal executive officer) August 3, 2023 By: /s/ Cecilia Jones Cecilia Jones Chief Financial Officer (principal financial officer) 59