Other Information
−Removed: (a) License Agreement with Alnylam
−Removed: 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.
−Removed: We intend to pursue development of a Licensed Product for the potential treatment of patients with polycythemia vera.
−Removed: 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.
−Removed: We will be solely responsible for the development and commercialization of Licensed Products in the Field and all costs associated therewith.
−Removed: 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.
−Removed: 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.
−Removed: Under the terms of the License Agreement, we are obligated to pay Alnylam an upfront payment of $17.5 million.
−Removed: 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.
−Removed: Unless earlier terminated, the License Agreement will expire upon the expiration of the last royalty term for the last Licensed Product in the Field.
−Removed: We may terminate the License Agreement in its entirety at any time upon 90 days’ prior written notice.
−Removed: 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.
−Removed: 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.
−Removed: 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
−Removed: 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.
+Added: A significant portion of the compensation of our directors and officers (as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, is in the form of equity awards and, from time to time, directors and officers engage in open-market transactions with respect to the securities acquired pursuant to such equity awards or other of our securities, including to satisfy tax withholding obligations when equity awards vest or are exercised, and for diversification or other personal reasons.
+Added: Transactions in our securities by directors and officers are required to be made in accordance with our insider trading policy, which requires that the transactions be in accordance with applicable U.S.
+Added: federal securities laws that prohibit trading while in possession of material nonpublic information.
+Added: Rule 10b5-1 under the Exchange Act provides an affirmative defense that enables directors and officers to prearrange transactions in our securities in a manner that avoids concerns about initiating transactions while in possession of material nonpublic information.
+Added: During the quarterly period covered by this report, Sarah Gheuens , M.D., Ph.D., our chief medical officer and head of research & development , entered into a Rule 10b5-1 trading arrangement that is intended to qualify as an “eligible sell-to-cover transaction” (as described in Rule 10b5-1(c)(1)(ii)(D)(3) under the Exchange Act).
+Added: This sell-to-cover arrangement applies to restricted stock units, or RSUs, whether vesting is based on the passage of time and/or the achievement of performance goals, granted to Dr.
+Added: Gheuens on July 1, 2023 and any RSUs that may be granted to her from time to time thereafter (other than those which by their terms require us to withhold shares for tax withholding obligations in connection with vesting and settlement).
+Added: This arrangement provides for the automatic sale of shares of our common stock that would otherwise be issuable on each settlement date of a covered RSU in an amount necessary to satisfy the applicable withholding obligation, with the proceeds of the sale delivered to us in satisfaction of the applicable withholding obligation.
+Added: The number of shares that will be sold under this arrangement is not currently determinable as the number will vary based on the extent to which vesting conditions are satisfied, the market price of our common stock at the time of settlement and the potential future grant of additional RSUs subject to this arrangement.
+Added: None of our directors or officers terminated a Rule 10b5-1 trading arrangement or adopted or terminated 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.
Incorporated by Reference
4 unchanged sentences
8-K 001-36014 March 3, 2023 3.1
−Removed: 10.1# 2023 Stock Incentive Plan
−Removed: S-8 333-272615 June 13, 2023 99.1
−Removed: 10.2# Form of Stock Option Agreement Under 2023 Stock Incentive Plan
−Removed: 10.3# Form of Restricted Stock Unit Agreement Under 2023 Stock Incentive Plan
−Removed: 10.4# Form of Restricted Stock Unit Agreement (Performance-Based) Under 2023 Stock Incentive Plan
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 .
13 unchanged sentences
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.
−Removed: # Indicates management contract or compensatory plan or arrangement.
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.
−Removed: August 3, 2023 By:
+Added: November 2, 2023 By:
/s/ Brian Goff
1 unchanged sentence
(principal executive officer)
−Removed: August 3, 2023 By:
+Added: November 2, 2023 By:
/s/ Cecilia Jones
3 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.