Responsibilities (Review and Approve) Clause Samples

Responsibilities (Review and Approve). The JSC’s responsibilities will include reviewing and approving (in each case, such approval not to be unreasonably withheld, conditioned or delayed) the following: 5.2.2.1 any change in the Development Program that is not required by, or made to respond to comments from, a Regulatory Authority, that would materially decrease the likelihood of obtaining or materially increase the timeline for obtaining a Regulatory Approval for the HNC Indication or the Melanoma Indication in the US, and that is: (a) a change to the Indication, 36 ACTIVE/105681617.22 (b) a change to any primary or secondary endpoint or the ordering of secondary endpoints of the HNC Main Clinical Trial as set forth on Exhibit D or any other HNC Clinical Trial, (c) a material change to the Statistical Analysis Plan or material reduction of the statistical powering of a HNC Clinical Trial as set forth in the Protocol for such HNC Clinical Trial, (d) the substitution or addition of any arms in any HNC Clinical Trial, (e) any material change to the inclusion criteria or exclusion criteria with respect to a HNC Clinical Trial as set forth in the applicable Protocol, or (f) any change from the CMO that is then engaged, or any material changes to the manufacturing process for either (i) the drug substance utilized in the Product or (ii) the final Product that, in either case, will be used in the HNC Clinical Trials; 5.2.2.2 commercially reasonable budgets of CRO and Third Party Vendor costs (the “Approved Third Party Vendor Costs”); and 5.2.2.3 any other matters the Parties mutually agree in writing will be, or are expressly provided in this Agreement to be, reviewed and approved by the JSC.

Responsibilities (Review and Approve). The JSC’s responsibilities will include reviewing and approving (in each case, such approval not to be unreasonably withheld, conditioned or delayed) the following: 5.2.2.1 the Protocols; 5.2.2.2 [***]: (a) [***]; (b) [***]; (c) [***]; (d) [***]; (e) [***]; or (f) [***]. (g) commercially reasonable budgets of CRO and Third Party Vendor costs (the “Approved Third Party Vendor Costs”) and Product Supply Costs. 5.2.2.3 any other matters the Parties mutually agree in writing will be, or are expressly provided in this Agreement to be, reviewed and approved by the JSC. The JSC shall use good faith efforts to approve budgets for the Approved Third Party Vendor Costs and the Product Supply Costs no later than [***].

Responsibilities (Review and Approve). The JSC’s responsibilities will include reviewing and approving the following: 5.2.2.1 changes to the funding schedule set forth in Section 4.3 for either Vutrisiran or ALN-AGT; 5.2.2.2 the determination as to whether the Phase 2 Success Criteria or the Phase 3 Success Criteria have been achieved; or 5.2.2.3 any other matters that the Parties mutually agree in writing will be, or are expressly provided in this Agreement to be, reviewed and approved by the JSC.