Common use of Joint Project Team Clause in Contracts

Joint Project Team. The Parties shall establish a joint project team (the Joint Project Team) made up of the Project Manager and at least [***] other representatives from each Party, which shall be responsible for coordinating all activities under this Agreement. Each Party may replace any of its Joint Project Team representatives upon prior notice to the other Party. In particular, the Joint Project Team shall be responsible for: (a) the review and discussion of the Development Plan and underlying objectives for Licensed Product #1 in the Field, [***] (b) co-ordinating the implementation of the Development Plan and the associated Budget; (c) the review and discussion of any proposed amendment or update to the Development Plan, whether during the annual review under Section 2.1.2 or from time to time during the Term, and the proposal of such amendment or update to the Joint Steering Committee for approval; (d) the review and discussion of: (i) the Budget for the applicable period pursuant to the annual review under Section 3.3.1(b), taking into account of any comments provided by the Joint Financial Committee under Section 6.5.2(b) and the applicable forecast prepared by the Joint Financial Committee under Section 6.5.2(c); and (ii) any other proposed amendment to the Binding Budget, and the proposal of each such amended Budget to the Joint Steering Committee for approval; (e) the review and approval of any proposed amendment(s) to the Binding Budget with respect to the then-current Calendar Year, provided that such Binding Budget shall not deviate by [***] or more from the Binding Budget for such Calendar Year as of the first day of such Calendar Year; (f) the review and discussion of the proposal by either Party of any modification to the Licensed Product #1 [***] (g) discussion and approval of which party should be responsible for the performance of which Co-Development Activities [***]. (h) discussion and approval of any Third Party proposed to be engaged by a Party to perform or assist with its obligations under this Agreement; (i) review and discussion of any Co-Development Reports, and discuss and agree whether additional information should be included in future Co-Development Reports; (j) oversight of all clinical and regulatory matters with respect to the Licensed Product #1 in the Field; (k) the preparation and review of all material Regulatory Documentation with respect to the Licensed Product #1 in the Field; (l) the coordination with the Joint Manufacturing Committee in relation to the CMC Development Plan and the forecasting of Drug Products for Clinical Trials (as defined in the Clinical Supply Agreement); (m) discussion and agreement on target product profiles; (n) periodically update the Joint Steering Committee with respect to Co-Development Activities performed and other relevant matters; (o) facilitating the sharing of data and information between the Parties in relation to the Development activities under the Development Plan, regulatory filings and regulatory approvals; (p) discussion and agreement of any alternative timeframe with respect to the discussion of, and submission to the Joint Financial Committee, a proposed Budget by the Joint Project Team as part of the annual review under Section 3.3.1(b); and (q) any other responsibilities allocated to the Joint Project Team by the Joint Steering Committee.

Joint Project Team. The Parties shall establish a joint project team (the Joint Project Team) made up of the Project Manager and at least [***] other representatives from each Party, which shall be responsible for coordinating all activities under this Agreement. Each Party may replace any of its Joint Project Team representatives upon prior notice to the other Party. In particular, the Joint Project Team shall be responsible for: : (a) the review and discussion of the Development Plan and underlying objectives for Licensed Product #1 in the Field, [***] ] (b) co-ordinating the implementation of the Development Plan and the associated Budget; ; (c) the review and discussion of any proposed amendment or update to the Development Plan, whether during the annual review under Section 2.1.2 or from time to time during the Term, and the proposal of such amendment or update to the Joint Steering Committee for approval; ; Amended & Restated Development Agreement Execution version 24 (d) the review and discussion of: (i) the Budget for the applicable period pursuant to the annual review under Section 3.3.1(b), taking into account of any comments provided by the Joint Financial Committee under Section 6.5.2(b) and the applicable forecast prepared by the Joint Financial Committee under Section 6.5.2(c); and (ii) any other proposed amendment to the Binding Budget, and the proposal of each such amended Budget to the Joint Steering Committee for approval; ; (e) the review and approval of any proposed amendment(s) to the Binding Budget with respect to the then-current Calendar Year, provided that such Binding Budget shall not deviate by [***] or more from the Binding Budget for such Calendar Year as of the first day of such Calendar Year; ; (f) the review and discussion of the proposal by either Party of any modification to the Licensed Product #1 [***] ] (g) discussion and approval of which party should be responsible for the performance of which Co-Development Activities [***]. ] (h) discussion and approval of any Third Party proposed to be engaged by a Party to perform or assist with its obligations under this Agreement; ; (i) review and discussion of any Co-Development Reports, and discuss and agree whether additional information should be included in future Co-Development Reports; ; (j) oversight of all clinical and regulatory matters with respect to the Licensed Product #1 in the Field; ; (k) the preparation and review of all material Regulatory Documentation with respect to the Licensed Product #1 in the Field; ; (l) the coordination with the Joint Manufacturing Committee in relation to the CMC Development Plan and the forecasting of Drug Products for Clinical Trials (as defined in the Clinical Supply Agreement); ; (m) discussion and agreement on target product profiles; ; (n) periodically update the Joint Steering Committee with respect to Co-Development Activities performed and other relevant matters; ; (o) facilitating the sharing of data and information between the Parties in relation to the Development activities under the Development Plan, regulatory filings and regulatory approvals; ; (p) discussion and agreement of any alternative timeframe with respect to the discussion of, and submission to the Joint Financial Committee, a proposed Budget by the Joint Project Team as part of the annual review under Section 3.3.1(b); and and (q) any other responsibilities allocated to the Joint Project Team by the Joint Steering Committee. 6.3.1 The quorum for each Joint Project Team meeting shall be at least one (1) Joint Project Team representative from each Party. Each Party shall have one collective vote in all decisions of the Joint Project Team with respect to matters falling within its responsibility, and shall use good faith efforts to decide such matters unanimously. If consensus cannot be reached by the Joint Project Team, the relevant matter shall be escalated to the Joint Steering Committee for discussion and decision. 6.3.2 Each Party hereby acknowledges and agrees that, notwithstanding the last sentence of Section 11.2.2 of the License Agreement, the Joint Steering Committee shall be responsible for: (a) the discussion and agreement of any matter escalated by the Joint Project Team or the Joint Financial Committee under Section 6.3.1 or Section 6.5.3 (as applicable) for resolution by the Joint Steering Committee; (b) the discussion and agreement of updates to the Development Plan as part of the annual review under Section 2.1.2 or updates to the Budget as part of annual review under Section 3.3.1

Joint Project Team. The (a) Establishment of the JPT. Within [**] after the A&R Effective Date, the Parties shall establish a joint project team (the Joint Project Team) made up “JPT”). The JPT shall be composed of the Project Manager and at least [**], but no more than [**], representatives designated by each Party (and the Parties need not have the same number of representatives). The representatives shall be appropriate (in terms of their seniority, training, experience, availability, and function) for the tasks being undertaken in the Research Programs and Optimization Program(s). Each Party shall bear the expense of its respective representatives’ participation on the JPT. A Party’s representative on the JPT may not also be a Party’s representative on the JRC. (b) JPT Co-Leads. Each Party shall designate one of its JPT representatives as its primary JPT contact for JPT matters (such Party’s “JPT Co-Lead”). A Party may replace any or all of its JPT representatives (and designated JPT Co-Lead) at any time notifying the other Party’s Alliance Manager in writing (which may be by email). [**] other representatives from each Party, which JPT Co-Lead shall be responsible for coordinating all activities under this Agreement. Each Party may replace any of its Joint Project Team representatives upon prior notice to the other Party. In particular, the Joint Project Team shall be responsible for: (a) the review scheduling JPT meetings and discussion of the Development Plan setting meeting agendas and underlying objectives for Licensed Product #1 in the Field, [***] (b) co-ordinating the implementation of the Development Plan and the associated Budget;calling emergency JPT meetings. (c) Responsibilities of the review JPT. The JPT shall be responsible for performing the following functions: (i) draft each initial Research Plan and discussion of any proposed amendment or update initial Optimization Plan and present such plans to the Development Plan, whether during the annual review under Section 2.1.2 or from time to time during the Term, and the proposal of such amendment or update to the Joint Steering Committee JRC for approval; (dii) the propose, review and discussion of: approve changes to an approved Research Plan or to an approved Optimization Plan (iother than changes to Completion Criteria or Optimization Completion Criteria) (iii) the Budget propose for the applicable period pursuant JRC’s review and approval changes to the annual review under Section 3.3.1(b), taking into account of any comments provided by Completion Criteria in an approved Research Plan or the Joint Financial Committee under Section 6.5.2(b) and the applicable forecast prepared by the Joint Financial Committee under Section 6.5.2(c); and (ii) any other proposed amendment to the Binding Budget, and the proposal of each such amended Budget to the Joint Steering Committee for approvalOptimization Completion Criteria in an approved Optimization Plan; (eiv) the review and approval of any proposed amendment(s) to the Binding Budget with respect to the then-current Calendar Year, provided that such Binding Budget shall not deviate by [***] or more from the Binding Budget for such Calendar Year as of the first day of such Calendar Year; (f) the review and discussion of the proposal by either Party of any modification to the Licensed Product #1 [***] (g) discussion and approval of which party should be responsible for the monitor each Party’s performance of which Co-Development Activities [***]. (h) discussion and approval of any Third Party proposed to be engaged by a Party to perform or assist with its their respective obligations under this Agreement; (i) review and discussion of any Co-Development Reports, and discuss and agree whether additional information should be included in future Co-Development Reports; (j) oversight of all clinical and regulatory matters with respect to the Licensed Product #1 in the Field; (k) the preparation and review of all material Regulatory Documentation with respect to the Licensed Product #1 in the Field; (l) the coordination with the Joint Manufacturing Committee in relation to the CMC Development each Research Plan and the forecasting of Drug Products for Clinical Trials (as defined in the Clinical Supply Agreement)Optimization Plan; (m) discussion and agreement on target product profiles; (n) periodically update the Joint Steering Committee with respect to Co-Development Activities performed and other relevant matters; (o) facilitating the sharing of data and information between the Parties in relation to the Development activities under the Development Plan, regulatory filings and regulatory approvals; (p) discussion and agreement of any alternative timeframe with respect to the discussion of, and submission to the Joint Financial Committee, a proposed Budget by the Joint Project Team as part of the annual review under Section 3.3.1(b); and (q) any other responsibilities allocated to the Joint Project Team by the Joint Steering Committee.