JSC Responsibilities and Decision-Making Clause Samples
The "JSC Responsibilities and Decision-Making" clause defines the roles, duties, and authority of the Joint Steering Committee (JSC) within a collaborative agreement. It typically outlines how the JSC will be composed, the scope of its decision-making powers, and the procedures for reaching decisions, such as voting requirements or consensus mechanisms. For example, the clause may specify that the JSC oversees project milestones, resolves disputes, or approves changes to the project plan. Its core function is to establish a clear governance structure, ensuring that both parties have a defined process for joint oversight and decision-making, thereby reducing ambiguity and potential conflicts during the collaboration.
JSC Responsibilities and Decision-Making. 8.2.1 The JSC shall discuss and review (i) overall strategic direction of the Project; (ii) the Funding Budget and Development Plan; (iii) material changes in or amendments to the Funding Budget and Development Plan submitted by Capital or proposed by the JSC; (iv) forecasts of the estimated timeline for Development activities of the Products; and (v) any other matters the Parties mutually agree in writing shall be subject to discussion and review by the JSC.
8.2.2 The JSC shall discuss, review and approve (i) any increases or decreases in the Funding Budget, and (ii) any other matters the Parties mutually agree in writing shall be subject to approval by the JSC.
8.2.3 The JSC shall have no authority to (i) amend, modify or waive compliance with this Agreement, or (ii) resolve any dispute concerning the validity, interpretation, construction of, or breach of this Agreement.
8.2.4 Conduit shall have the sole right to approve any amendments to Funding Budget and the Development Plan, taking into account any reasonable comments of the JSC.
JSC Responsibilities and Decision-Making. 5.2.1 Responsibilities (Review and Discuss). The JSC’s responsibilities will include reviewing and discussing (but not approving) the following:
5.2.1.1 Oversight of the Parties’ collaboration for PNH including (i) overall strategic direction, (ii) developing strategies to maximize the value of the Product for the treatment of PNH, and (iii) reviewing and commenting on the Development Program and Regulatory Approval strategies;
5.2.1.2 material changes in the Development Program, including changes required by, or made to respond to comments from, a Regulatory Authority, that do not require approval pursuant to Section 5.2.2;
5.2.1.3 the activities related to, the progress of, and the costs incurred in connection with, the Development Program;
5.2.1.4 summaries of the Research Results;
5.2.1.5 Apellis’ forecast of the estimated timeline (on at least a [**] basis) for its development activities with respect to the Product for PNH;
5.2.1.6 the addition to the Development Program of any new clinical trial testing the efficacy of the Product for PNH; and
5.2.1.7 any other matters the Parties mutually agree will be, or are expressly provided in this Agreement to be, reviewed and discussed by the JSC.
JSC Responsibilities and Decision-Making. 5.2.1 Responsibilities (Review and Discuss). The JSC’s responsibilities will include reviewing and discussing (but not approving) the following at regularly scheduled meetings:
5.2.1.1 the progress of the Development Programs and the overall Regulatory Approval and Commercialization strategies for the Products;
5.2.1.2 material changes in the Development Programs, including material changes required by, or made to respond to comments from, a Regulatory Authority;
5.2.1.3 the Development Costs incurred in connection with, the Development Programs;
5.2.1.4 a material change to a Protocol, including (a) a material change to the statistical analysis plan attached hereto as Exhibit G, (b) a material reduction of the statistical powering of a Product Clinical Trial as set forth in the Protocol for such Product Clinical Trial, or (c) any material change to the inclusion criteria or exclusion criteria with respect to a Product Clinical Trial as set forth in the applicable Protocol;
5.2.1.5 the substitution or addition of any arms in any Product Clinical Trial;
5.2.1.6 material changes or revisions to the Timeline for the Product Clinical Trials;
5.2.1.7 Licensing Transactions between Alnylam and a Third Party that could materially impact Alnylam’s ability to make the Success Payments in accordance with Section 3.7;
5.2.1.8 the addition to the Development Program of any new Clinical Trials testing the efficacy of a Product; and
5.2.1.9 any other matters the Parties mutually agree in writing will be, or are expressly provided in this Agreement to be, reviewed and discussed by the JSC.
JSC Responsibilities and Decision-Making. 5.2.1 Responsibilities [***]. The JSC’s responsibilities will include [***] the following:
5.2.1.1 the Product and the progress of Opthea’s Development Program including (i) overall clinical, regulatory and commercial strategic direction of the Development Program, (ii) developing strategies to maximize the value of the Product, and (iii) reviewing and commenting on the Development Program and Regulatory Approval strategies for the Product;
5.2.1.2 Opthea’s use, including planned use, of the Development Costs provided pursuant to Section 4.2 for Opthea’s Development Program (including summaries of budgets for and payments to CROs, CMOs and other Permitted Third Parties);
5.2.1.3 [***];
5.2.1.4 [***]; and
5.2.1.5 [***].
5.2.2 Responsibilities [***]. The JSC’s responsibilities will include [***] the following:
5.2.2.1 a change to the indication for the Product set forth in the current Development Plan from the Indication to any other indication;
5.2.2.2 [***];
5.2.2.3 [***];
5.2.2.4 [***];
5.2.2.5 the substitution or addition of any arms in any Product Clinical Trial;
5.2.2.6 a determination to discontinue the Development Program;
5.2.2.7 any material changes to the manufacturing process for either (a) the drug substance utilized in any Product or (b) any final Product that, in either case, will be used in the Product Clinical Trials; or
5.2.2.8 [***].