Common use of Formation and Role Clause in Contracts

Formation and Role. Promptly, and in any event within [**] days after the Effective Date, the Parties shall establish a joint steering committee (the “Joint Steering Committee” or “JSC”) to coordinate, oversee, review and discuss the Parties’ activities with respect to the Development of Licensed Products hereunder. For that purpose and to the extent reasonably necessary, the JSC will: (i) coordinate the activities of the Parties under the Development Plan, including facilitating communications and discussions between the Parties with respect to the Development of Licensed Products under the Development Plan; (ii) review, discuss and approve any proposed amendments or revisions to the Development Plan; (iii) oversee technology transfer from Concert to Jazz; (iv) establish the criteria for Successful Completion of a Phase 1 Clinical Trial and Phase 2 PoC Clinical Trial pursuant to Section 4.4(a); (v) determine whether the criteria for Successful Completion have been satisfied pursuant to Section 4.4(b); (vi) establish such Working Groups as it deems necessary to achieve the objectives and intent of this Agreement; and (vii) perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as determined by the Parties in writing. The JSC shall have only the powers expressly assigned to it in this Section 3.1 and elsewhere in this Agreement, and shall have no power to amend, modify, or waive compliance with this Agreement.

Formation and Role. Promptly, and in any event within [**] thirty (30) days after the Effective Date, the Parties shall establish a joint steering development committee (the “Joint Steering Development Committee” or “JSCJDC”) to coordinate, oversee, review and discuss the Parties’ activities with respect to the Development of Licensed Products hereunder. For that purpose and to the extent reasonably necessary, the JSC such JDC will: (i) coordinate the activities of the Parties under the Development PlanPlans, including facilitating communications information exchange and discussions between the Parties with respect to the Development of Licensed Products Products, the progress and results (whether preliminary or final) under the Development PlanPlans and ROFN Products; (ii) review, review and discuss and approve any proposed amendments or revisions to the Development PlanPlans; (iii) oversee technology transfer from Concert review and discuss any cost to Jazzbe shared by the Parties; (iv) establish oversee all activities relating to the criteria for Successful Completion of a Phase 1 Clinical Trial manufacturing-related activities, including Product supply, process development/optimization and Phase 2 PoC Clinical Trial pursuant to Section 4.4(a)any related procedures; (v) determine whether the criteria for Successful Completion have been satisfied pursuant oversee technology transfer from Pfenex to Section 4.4(b)Jazz’s Third Party manufacturer, if applicable; (vi) establish such Working Groups as it deems necessary to achieve the objectives and intent of this Agreement; and; (vii) discuss the mitigation of potential delays related to the Development Plan and review any actual delays related to the Development Plan; (viii) perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as determined agreed by the Parties in writing. It is the expectation of the Parties that the JDC will set forth the general principles and strategies upon which the Parties will perform their activities under the Development Plans. The JSC JDC shall have only the powers expressly assigned to it in this Section 3.1 and elsewhere in this Agreement, and all other matters are expressly excluded. In no event shall the JDC have no power the right to amend, modify, or waive compliance with this Agreement.

Formation and Role. Promptly, and in any event within [**] days ten (10) Business Days after the Effective Date, the Parties shall establish a joint steering committee (the “Joint Steering Committee” or “JSC”) to coordinate, overseecoordinate and oversee the Parties’ activities under this Agreement through the completion of all activities under the Development Plan. The role of the JSC shall be to manage, review and discuss the Parties’ activities with respect to the Development of the Licensed Products hereunderCompound and Licensed Products, including the determination of appropriate pharmacokinetic profiles to be pursued with respect to the Licensed Compound. For that purpose and to the extent reasonably necessary, the JSC will: (i) review, discuss and approve of the initial Development Plan pursuant to Section 4.2, including the identification of appropriate pharmacokinetic profiles to be pursued, and any proposed material amendments or revisions to the then-current Development Plan; (ii) coordinate the activities of the Parties under the Development Plan, including facilitating communications and discussions between the Parties with respect to the Development of the Licensed Compound and Licensed Products under the Development Plan; (ii) review, discuss and approve any proposed amendments or revisions to the Development Plan; (iii) oversee technology transfer from Concert NeuRx to Jazz; (iv) establish the criteria for Successful Completion of a Phase 1 Clinical Trial and Phase 2 PoC Clinical Trial Neos, pursuant to Section 4.4(a); (v) determine whether the criteria for Successful Completion have been satisfied pursuant to Section 4.4(b); (vi) establish such Working Groups as it deems necessary to achieve the objectives Sections 2.2 and intent of this Agreement6.2; and (viiiv) perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as determined by the Parties in writing. The JSC shall have only the powers expressly assigned to it in this Section 3.1 and elsewhere in this Agreement, and shall have no power to amend, modify, or waive compliance with this Agreement.

Formation and Role. Promptly, and in any event within [**] thirty (30) days after the Effective Date, the Parties shall establish a joint steering development committee (the “Joint Steering Development Committee” or “JSCJDC”) to coordinate, oversee, review and discuss the Parties’ activities with respect to the Development of Licensed Products hereunder. For that purpose and to the extent reasonably necessary, the JSC such JDC will: (i) coordinate the activities of the Parties under the Development PlanPlans, including facilitating communications information exchange and discussions between the Parties with respect to the Development of Licensed Products Products, the progress and results (whether preliminary or final) under the Development PlanPlans and ROFN Products; (ii) review, review and discuss and approve any proposed amendments or revisions to the Development PlanPlans; (iii) oversee technology transfer from Concert review and discuss any cost to Jazzbe shared by the Parties; (iv) establish oversee all activities relating to the criteria for Successful Completion of a Phase 1 Clinical Trial manufacturing-related activities, including Product supply, process development/optimization and Phase 2 PoC Clinical Trial pursuant to Section 4.4(a)any related procedures; (v) determine whether the criteria for Successful Completion have been satisfied pursuant oversee technology transfer from Pfenex to Section 4.4(b)Jazz’s Third Party manufacturer, if applicable; (vi) establish such Working Groups as it deems necessary to achieve the objectives and intent of this Agreement; and (vii) perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as determined agreed by the Parties in writing. It is the expectation of the Parties that the JDC will set forth the general principles and strategies upon which the Parties will perform their activities under the Development Plans. The JSC JDC shall have only the powers expressly assigned to it in this Section 3.1 and elsewhere in this Agreement, and all other matters are expressly excluded. In no event shall the JDC have no power the right to amend, modify, or waive compliance with this Agreement.