1Responsibilities Clause Samples
1Responsibilities. The JSC shall perform the following functions, subject to the limitations and final decision-making authority of the respective Parties as set forth in Section 4.4:
(a) serve as an information transfer vehicle to facilitate discussions regarding the Development of HD Candidates and progress under the HD Program Plan, including the HD Program Timelines, with respect to the HD Program;
(b) finalize the HD DC Criteria within [**] after the Effective Date;
(c) review and determine whether to update the HD Program Plan (including the Development Budget) at the end of each [**], or at other times, in accordance with Section 3.1;
(d) review and approve any substantive amendments to the HD Program Plan proposed by a Party, including any amendments to the Development Budget;
(e) review and discuss progress reports on the Parties’ activities under the HD Program Plan as submitted by each Party, including the reports submitted under Section 3.3 and the progress with respect to the HD Program Timelines;
(f) address any issues or disputes arising between the Parties regarding the conduct of the Parties’ activities under the HD Program Plan;
(g) review and discuss HD Program Product formulation and formulation optimization;
(h) form such Subcommittees as it deems necessary to achieve the objectives and intent of the HD Program in accordance with this Agreement; and
(i) perform such other responsibilities as may be expressly assigned to the JSC pursuant to this Agreement or as may be mutually agreed upon in writing by the Parties (through their authorized representatives outside of the JSC) in writing from time to time. Notwithstanding anything to the contrary, the JSC shall not have any authority beyond the specific matters set forth in this Section 4.1.1, and the JSC’s authority will be subject to the limitations set forth in Section 4.4.4.
