Common use of Function and Powers of the JDC Clause in Contracts

Function and Powers of the JDC. During the Merck Participation Term for a given Program, without limiting the generality of this Section 2.5, the JDC shall oversee and facilitate the conduct of the Development of Collaboration Products during the Merck Participation Term for such Program, including to: (i) monitor and oversee the Development activities under the Development Plan, including timely sharing and discussion of any material results or events relating to such Development activities and discussion of any anticipated cost overruns; (ii) oversee the conduct of and monitor progress of any Clinical Studies under the Joint Development Plan and Budget for such Program; (iii) decide whether and when to initiate or discontinue any Clinical Study under the Joint Development Plan and Budget for such Program; (iv) facilitate the flow of information between the Parties with respect to the Development of Collaboration Products for such Program; (v) discuss and review the overall strategy regarding Regulatory Approval of Collaboration Products in the Territory for such Program; (vi) provide a forum for discussion of any regulatory related activities and maintenance of INDs or CTAs for Collaboration Products and initial Regulatory Approvals for Collaboration Products for such Program; (vii) review the Development Transition Plans for such Program; (viii) coordinate with the JMC regarding enrollment for Clinical Studies for Collaboration Products, including the forecast for Manufacturing capacity and the applicable enrollment rate; (ix) discuss any Additional Study(ies) proposed by either Party for such Program; and (x) until the formation of the JCC, discuss, when available to Merck, the applicable and relevant components of the initial Global Commercialization Plan for such Program; provided that for clarity, the JDC will not oversee the Commercialization activities with respect to Collaboration Products, and such Commercialization activities shall be under the purview of the JCC, as, and to the extent, applicable.

Appears in 4 contracts

Samples: Mrna Cancer Vaccine Collaboration and License Agreement, Mrna Cancer Vaccine Collaboration and License Agreement, Mrna Cancer Vaccine Collaboration and License Agreement (Moderna, Inc.)

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