Common use of Internal SAV Programs Clause in Contracts

Internal SAV Programs. (i) During the SAV Research Term, if a non-proposing Party reasonably declines in writing to participate in a program for a Target(s) that is proposed pursuant to an SAV Target Notice in accordance with Section 3.1(c)(iii), or fails to respond in writing to the proposing Party within [***] days of receipt of the applicable SAV Target Notice, then the proposing Party may elect, in its sole discretion, to provide written notice, within [***] days after the date that the non-proposing Party declines in writing to participate (or fails to respond, as applicable), to the non-proposing Party to conduct an Internal SAV Program for such proposed Target(s), and (A) upon the date of such written notice, the proposing Party shall conduct an “Internal SAV Program” for such Target(s) and shall be the “ISP Party” for such Internal SAV Program, (B) the ISP Party shall promptly thereafter (and in any event within [***] days) prepare in writing and provide to the non-ISP Party an Internal SAV Program Plan for such Internal SAV Program consistent with the SAV Target Notice, with the goal of Researching SAVs Directed against such Target(s) under the Internal SAV Program Plan through the selection of a Lead SAV Candidate, and (C) the Parties shall promptly discuss in good faith and agree upon the definition of [***] to be set forth in the Internal SAV Program Plan for such Internal SAV Program, [***]. (ii) The ISP Party for such Internal SAV Program, [***], will undertake Research and such other activities as set forth in the applicable Internal SAV Program Plan for such Internal SAV Program to generate information to prepare the Pre-GLP Tox Data Package for such Internal SAV Program. If Merck is the ISP Party for such Merck Internal SAV Program, Moderna will Manufacture and supply SAVs (including mRNA Constructs therefor) Directed against the applicable Target(s) for such Merck Internal SAV Program, all in accordance with the supply terms set forth in Exhibit N. An ISP Party may terminate its Internal SAV Program for any reason upon [***] days written notice to the non-ISP Party. If an ISP Party does not actively conduct its Internal SAV Program [***], then the ISP Party shall provide prompt written notice to the non-ISP Party of such discontinuation [***], and as of the date of such written notice, [***]. (iii) During the Internal SAV Program Term for a given Internal SAV Program, the Parties shall present and review, via the POC Committee, the status of the Research activities for such Internal SAV Program and the data generated thereunder. Upon [***], the ISP Party will promptly (and in any event within [***] days) prepare and provide to the non-ISP Party the Pre-GLP Tox Data Package for such Internal SAV Program. After the delivery of the Pre-GLP Tox Data Package and for the remainder of the Internal SAV Program Term for such Internal SAV Program, the ISP Party shall, as reasonably requested by the non-ISP Party, meet with the non-ISP Party to discuss such Pre-GLP Tox Data Package and any questions of the non-ISP Party with respect thereto, including providing the non-ISP Party with certain additional information as the non- ISP Party may reasonably request to assist with interpretation of such Pre-GLP Tox Data Package. (iv) On an Internal SAV Program-by-Internal SAV Program basis, the ISP Party hereby grants to the non-ISP Party, during the Internal SAV Program Term for a given Internal SAV Program, the exclusive right, exercisable at the non-ISP Party’s sole discretion in accordance with Section 3.1(d)(v) below, to elect to continue, in collaboration with the ISP Party, the Research, Development, Manufacture and Commercialization of mRNA Cancer Vaccines (including Collaboration Products) for such Internal SAV Program (and the Target(s) thereunder) as a Joint SAV Program, and to exercise the licenses set forth in Section 10.1(a)(ii) or 10.2(a)(ii) (as applicable) with respect to such mRNA Cancer Vaccines (including Collaboration Products) for such Internal SAV Program as a Joint SAV Program, in each case, solely under the terms and conditions set forth in this Agreement (each such election, a “Pre-GLP Tox Election”). During the Internal SAV Program Term for a given Moderna Internal SAV Program, Merck may terminate its Pre-GLP Tox Election for such Moderna Internal SAV Program upon written notice to Moderna. In the event that Merck terminates its Pre-GLP Tox Election for a given Moderna Internal SAV Program, then the consequences set forth in Section 3.1(d)(vi) shall apply with respect to such Moderna Internal SAV Program (mutatis mutandis); provided, however, [***]. (v) On an Internal SAV Program-by-Internal SAV Program basis, the non-ISP Party may elect to exercise the Pre-GLP Tox Election for a given Internal SAV Program by delivering to the ISP Party written notice of such exercise at any time during the Internal SAV Program Term for such Internal SAV Program (each, a “Pre-GLP Tox Election Notice”). Commencing on the Pre-GLP Tox Election Date for a given Internal SAV Program, (A) each Target(s) for such Internal SAV Program shall become an “SAV Target”, (B) such Internal SAV Program shall be converted into a “Joint SAV Program” and (C) the Parties shall engage in such Joint SAV Program for such SAV Target(s) in accordance with Section 3.1(c)(ii), including preparing a POC Plan for such Joint SAV Program as soon as reasonably practicable (and in any event within [***] days) after such Pre-GLP Tox Election Date. (vi) For a given Moderna Internal SAV Program, if Moderna delivers a Pre-GLP Tox Data Package for such Moderna Internal SAV Program and Merck does not exercise the Pre-GLP Tox Election for such Moderna Internal SAV Program during the Internal SAV Program Term, then, upon written notice to Merck within [***] days after the Pre-GLP Tox Commitment Date for such Moderna Internal SAV Program, Moderna shall be entitled to [***], Development, Manufacturing and Commercialization program for the Target(s) for such Moderna Internal SAV Program outside the Collaboration and without any further compensation to Merck, and (A) each such Target shall be deemed a Released Target and the Moderna Internal SAV Program shall be deemed terminated for purposes of this Agreement, (B) the licenses set forth in Section 10.1(d) may not be exercised by Merck with respect to such Released Target(s) and (C) the exclusivity provisions set forth in Sections 10.7(c) and 10.8(b) shall terminate with respect to the Released Target(s) and the provisions set forth in Sections 10.7(d)(iv) and 10.8(c)(iv) shall terminate with respect to the Collaboration Shared Neoepitope(s) under such Moderna Internal SAV Program, [***]. (vii) For a given Merck Internal SAV Program, if Merck delivers a Pre-GLP Tox Data Package for such Merck Internal SAV Program and Moderna does not exercise the Pre-GLP Tox Election for such Merck Internal SAV Program during the Internal SAV Program Term, then Merck may elect upon written notice to Moderna within [***] days after the Pre-GLP Tox Commitment Date for such Merck Internal SAV Program to either (1) convert such Merck Internal SAV Program to a “Joint SAV Program” and each such Target to an “SAV Target”; provided that

Internal SAV Programs. (i) During the SAV Research Term, if a non-proposing Party reasonably declines in writing to participate in a program for a Target(s) that is proposed pursuant to an SAV Target Notice in accordance with Section 3.1(c)(iii), or fails to respond in writing to the proposing Party within [***] days of receipt of the applicable SAV Target Notice, then the proposing Party may elect, in its sole discretion, to provide written notice, within [***] days after the date that the non-proposing Party declines in writing to participate (or fails to respond, as applicable), to the non-proposing Party to conduct an Internal SAV Program for such proposed Target(s), and (A) upon the date of such written notice, the proposing Party shall conduct an “Internal SAV Program” for such Target(s) and shall be the “ISP Party” for such Internal SAV Program, (B) the ISP Party shall promptly thereafter (and in any event within [***] days) prepare in writing and provide to the non-ISP Party an Internal SAV Program Plan for such Internal SAV Program consistent with the SAV Target Notice, with the goal of Researching SAVs Directed against such Target(s) under the Internal SAV Program Plan through the selection of a Lead SAV Candidate, and (C) the Parties shall promptly discuss in good faith and agree upon the definition of [***] to be set forth in the Internal SAV Program Plan for such Internal SAV Program, [***]. (ii) The ISP Party for such Internal SAV Program, [***], will undertake Research and such other activities as set forth in the applicable Internal SAV Program Plan for such Internal SAV Program to generate information to prepare the Pre-GLP Tox Data Package for such Internal SAV Program. If Merck is the ISP Party for such Merck Internal SAV Program, Moderna will Manufacture and supply SAVs (including mRNA Constructs therefor) Directed against the applicable Target(s) for such Merck Internal SAV Program, all in accordance with the supply terms set forth in Exhibit N. An ISP Party may terminate its Internal SAV Program for any reason upon [***] days written notice to the non-ISP Party. If an ISP Party does not actively conduct its Internal SAV Program [***], then the ISP Party shall provide prompt written notice to the non-ISP Party of such discontinuation [***], and as of the date of such written notice, [***]. (iii) During the Internal SAV Program Term for a given Internal SAV Program, the Parties shall present and review, via the POC Committee, the status of the Research activities for such Internal SAV Program and the data generated thereunder. Upon [***], the ISP Party will promptly (and in any event within [***] days) prepare and provide to the non-ISP Party the Pre-GLP Tox Data Package for such Internal SAV Program. After the delivery of the Pre-GLP Tox Data Package and for the remainder of the Internal SAV Program Term for such Internal SAV Program, the ISP Party shall, as reasonably requested by the non-ISP Party, meet with the non-ISP Party to discuss such Pre-GLP Tox Data Package and any questions of the non-ISP Party with respect thereto, including providing the non-ISP Party with certain additional information as the non- non-ISP Party may reasonably request to assist with interpretation of such Pre-GLP Tox Data Package. (iv) On an Internal SAV Program-by-Internal SAV Program basis, the ISP Party hereby grants to the non-ISP Party, during the Internal SAV Program Term for a given Internal SAV Program, the exclusive right, exercisable at the non-ISP Party’s sole discretion in accordance with Section 3.1(d)(v) below, to elect to continue, in collaboration with the ISP Party, the Research, Development, Manufacture and Commercialization of mRNA Cancer Vaccines (including Collaboration Products) for such Internal SAV Program (and the Target(s) thereunder) as a Joint SAV Program, and to exercise the licenses set forth in Section 10.1(a)(ii) or 10.2(a)(ii) (as applicable) with respect to such mRNA Cancer Vaccines (including Collaboration Products) for such Internal SAV Program as a Joint SAV Program, in each case, solely under the terms and conditions set forth in this Agreement (each such election, a “Pre-GLP Tox Election”). During the Internal SAV Program Term for a given Moderna Internal SAV Program, Merck may terminate its Pre-GLP Tox Election for such Moderna Internal SAV Program upon written notice to Moderna. In the event that Merck terminates its Pre-GLP Tox Election for a given Moderna Internal SAV Program, then the consequences set forth in Section 3.1(d)(vi) shall apply with respect to such Moderna Internal SAV Program (mutatis mutandis); provided, however, [***]. (v) On an Internal SAV Program-by-Internal SAV Program basis, the non-ISP Party may elect to exercise the Pre-GLP Tox Election for a given Internal SAV Program by delivering to the ISP Party written notice of such exercise at any time during the Internal SAV Program Term for such Internal SAV Program (each, a “Pre-GLP Tox Election Notice”). Commencing on the Pre-GLP Tox Election Date for a given Internal SAV Program, (A) each Target(s) for such Internal SAV Program shall become an “SAV Target”, (B) such Internal SAV Program shall be converted into a “Joint SAV Program” and (C) the Parties shall engage in such Joint SAV Program for such SAV Target(s) in accordance with Section 3.1(c)(ii), including preparing a POC Plan for such Joint SAV Program as soon as reasonably practicable (and in any event within [***] days) after such Pre-GLP Tox Election Date. (vi) For a given Moderna Internal SAV Program, if Moderna delivers a Pre-GLP Tox Data Package for such Moderna Internal SAV Program and Merck does not exercise the Pre-GLP Tox Election for such Moderna Internal SAV Program during the Internal SAV Program Term, then, upon written notice to Merck within [***] days after the Pre-GLP Tox Commitment Date for such Moderna Internal SAV Program, Moderna shall be entitled to [***], Development, Manufacturing and Commercialization program for the Target(s) for such Moderna Internal SAV Program outside the Collaboration and without any further compensation to Merck, and (A) each such Target shall be deemed a Released Target and the Moderna Internal SAV Program shall be deemed terminated for purposes of this Agreement, (B) the licenses set forth in Section 10.1(d) may not be exercised by Merck with respect to such Released Target(s) and (C) the exclusivity provisions set forth in Sections 10.7(c) and 10.8(b) shall terminate with respect to the Released Target(s) and the provisions set forth in Sections 10.7(d)(iv) and 10.8(c)(iv) shall terminate with respect to the Collaboration Shared Neoepitope(s) under such Moderna Internal SAV Program, [***]. (vii) For a given Merck Internal SAV Program, if Merck delivers a Pre-GLP Tox Data Package for such Merck Internal SAV Program and Moderna does not exercise the Pre-GLP Tox Election for such Merck Internal SAV Program during the Internal SAV Program Term, then Merck may elect upon written notice to Moderna within [***] days after the Pre-GLP Tox Commitment Date for such Merck Internal SAV Program to either (1) convert such Merck Internal SAV Program to a “Joint SAV Program” and each such Target to an “SAV Target”; provided thatthat (x) Merck will be [***]; provided, however, that at the request of Merck, the Parties will [***], or (2) terminate such Merck Internal SAV Program upon written notice to Moderna, provided that if Merck elects to exercise its rights under this clause (2), then (A) each Target for such Merck Internal SAV Program [***], (B) the licenses set forth in [***], (C) in such case, [***]terminate with respect to such Merck Internal SAV Program [***], (D) any outstanding purchase orders for mRNA Constructs to be delivered by Moderna to Merck in accordance with the supply terms set forth in Exhibit N will terminate with respect to such Merck Internal SAV Program, and (E) Merck shall have no further rights under Exhibit J with respect to such Merck Internal SAV Program.