Lilly Responsibilities. (a) Subject to Sections 4.1.2(a) and 5.6, after IND Filing Readiness, Lilly will be responsible for all further Development activities for the initial Licensed Product, including filing of the IND for such initial Licensed Product; and will also be responsible for all research and Development activities with respect to any second or subsequent Licensed Products (collectively, the “Lilly Research Activities”). For clarity, subject to Sections 4.1.2(a) and 5.6 and without limiting Sigilon’s supply-related obligations hereunder (including under Sections 7.5 and 7.6) and under any other written agreement between the Parties, Sigilon shall have no obligation to assist in the development of or fund any activities with respect to any Licensed Products other than as expressly provided under the Research Plan, unless mutually agreed by the Parties in writing. (b) Following Lilly’s approval of the IND Filing Package, Lilly agrees to use Commercially Reasonably Efforts to file within [***] months from such approval, in its own name, such IND Filing Package with the proper Regulatory Authority; provided, that, if at any time Lilly anticipates it will not file within such [***] month period, then Lilly will promptly notify Sigilon of such anticipated delay (and in any event, no later than [***] days following Lilly’s determination that new information unavailable at the time of such approval may cause such a delay) and the Parties will discuss the reasons for such delay, including any new information or factors that have arisen since Lilly’s approval of the IND Filing Package. Lilly shall provide or make available to Sigilon a copy of the IND Filing Package in the form submitted to such Regulatory Authority within [***] days following filing thereof. Lilly shall pay all filing fees associated with such filing.
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Sources: Research Collaboration and Exclusive License Agreement (Sigilon Therapeutics, Inc.), Research Collaboration and Exclusive License Agreement (Sigilon Therapeutics, Inc.)