Function and Powers of the Joint Steering Committee. During the Merck Participation Term for a given Program, the Joint Steering Committee shall have general strategic oversight of the Collaboration for such Program, and shall confer regarding the status of the Additional Research Plans and the Development Plans and the Research, Development, Manufacture and Commercialization of mRNA Cancer Vaccines (including Collaboration Products) for such Program. Without limiting the generality of the foregoing, the JSC shall have the following specific responsibilities during the Merck Participation Term for a given Program: (i) review and discuss the Joint Development Plan and Budget for such Program and all amendments thereto, and approve any such amendments for the Joint Development Plan and Budget for the PCV Program and annual budget updates for the Joint Development Plan and Budget for any Program in accordance with Section 4.3(c)(ii), including to determine the resources and activities allocated by each Party thereto (which resources and activities will be set forth in the Joint Development Plan and Budget for such Program); (ii) review and approve the Development Transition Plan for such Program; Program; (iii) review and comment on any Independent Additional Study Development Plan for such (iv) review and approve the Global Commercialization Plan, Global Commercialization Budget and global Commercialization strategy for such Program pursuant to Section 8.3; (v) [***]; (vi) review, discuss and coordinate the Parties’ scientific presentation and publication strategy relating to the Collaboration Products in the Territory for such Program in accordance with Section 12.2; by either Party; such Program; (vii) [***] (viii) review and approve any Additional Research Program(s) for such Program proposed (ix) oversee Research activities conducted pursuant to any Additional Research Plan for (x) review and discuss any actual or potential Safety Issue with respect to any Collaboration Product or any Other Component used in a Combination Product; (xi) provide guidance to the JDC, JMC or JCC and attempt to resolve issues for such Program presented to it by any other Committee; and (xii) perform such other functions as may be expressly delegated to the JSC pursuant to this Agreement.
Appears in 2 contracts
Samples: Mrna Cancer Vaccine Collaboration and License Agreement, Mrna Cancer Vaccine Collaboration and License Agreement
Function and Powers of the Joint Steering Committee. During the Merck Participation Term for a given Program, the Joint Steering Committee shall have general strategic oversight of the Collaboration for such Program, and shall confer regarding the status of the Additional Research Plans and the Development Plans and the Research, Development, Manufacture and Commercialization of mRNA Cancer Vaccines (including Collaboration Products) for such Program. Without limiting the generality of the foregoing, the JSC shall have the following specific responsibilities during the Merck Participation Term for a given Program:
(i) review and discuss the Joint Development Plan and Budget for such Program and all amendments thereto, and approve any such amendments for the Joint Development Plan and Budget for the PCV Program and annual budget updates for the Joint Development Plan and Budget for any Program in accordance with Section 4.3(c)(ii), including to determine the resources and activities allocated by each Party thereto (which resources and activities will be set forth in the Joint Development Plan and Budget for such Program);
(ii) review and approve the Development Transition Plan for such Program; Program;
(iii) review and comment on any Independent Additional Study Development Plan for suchsuch Program;
(iv) review and approve the Global Commercialization Plan, Global Commercialization Budget and global Commercialization strategy for such Program pursuant to Section 8.3;
(v) [***];
(vi) review, discuss and coordinate the Parties’ scientific presentation and publication strategy relating to the Collaboration Products in the Territory for such Program in accordance with Section 12.2; by either Party; such Program;
(vii) [***]
(viii) review and approve any Additional Research Program(s) for such Program proposedproposed by either Party;
(ix) oversee Research activities conducted pursuant to any Additional Research Plan forfor such Program;
(x) review and discuss any actual or potential Safety Issue with respect to any Collaboration Product or any Other Component used in a Combination Product;
(xi) provide guidance to the JDC, JMC or JCC and attempt to resolve issues for such Program presented to it by any other Committee; and
(xii) perform such other functions as may be expressly delegated to the JSC pursuant to this Agreement.
Appears in 2 contracts
Samples: Mrna Cancer Vaccine Collaboration and License Agreement (Moderna, Inc.), Mrna Cancer Vaccine Collaboration and License Agreement (Moderna, Inc.)