Common use of Formation; Responsibilities Clause in Contracts

Formation; Responsibilities. The Parties will establish a project team (the “Project Team”) to oversee and coordinate activities under the Global Development Plan. The Project Team will include members from each function identified on Schedule C-1. The initial Project Team members are set forth on Schedule C-2. If a Project Team member is no longer available to serve on the Project Team, the Parties will meet and discuss an appropriate replacement for such Project Team member from either Party, taking into account each Party’s expertise and resources in the relevant functional area. The appointment of the replacement Project Team member will require the JDC’s approval. Any member of the Project Team who is not dedicated to the Products under this Agreement on a full-time basis must be sufficiently dedicated to such Products to permit such person to be reasonably and consistently available to participate in the activities of the Project Team. The Project Team will be responsible for: (i) defining clinical and regulatory strategic options for recommendation to the JDC; (ii) providing guidance on regulatory activities for recommendation to the JDC; (iii) preparing joint deliverables, including updates to the Global Development Plan for submission to the JDC; (iv) preparing study protocols and statistical analysis plans for approval in accordance with Section 3.3.2(b); (v) preparing regulatory documentation for recommendation to the JDC; (vi) proposing goals, budgets and timelines for joint Development activities to the JDC; (vii) driving execution and ensuring the progress of Development activities in accordance with the Global Development Plan; and (viii) such additional matters as may be determined by the JDC. The Project Team shall act by consensus, with each Party’s representatives on the Project Team having collectively one vote. If the Project Team cannot reach consensus, the matter will be referred to the JDC for resolution. [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Table of Contents

Appears in 2 contracts

Sources: Joint Development and Commercialization Agreement, Joint Development and Commercialization Agreement (CRISPR Therapeutics AG)

Formation; Responsibilities. The Parties will establish a project team (the “Project Team”) to oversee and coordinate activities under the Global Development Plan. The Project Team will include members from each function identified on Schedule C-1. The initial Project Team members are set forth on Schedule C-2. If a Project Team member is no longer available to serve on the Project Team, the Parties will meet and discuss an appropriate replacement for such Project Team member from either Party, taking into account each Party’s expertise and resources in the relevant functional area. The appointment of the replacement Project Team member will require the JDC’s approval. Any member of the Project Team who is not dedicated to the Products under this Agreement on a full-time basis must be sufficiently dedicated to such Products to permit such person to be reasonably and consistently available to participate in the activities of the Project Team. The Project Team will be responsible for: (i) defining clinical and regulatory strategic options for recommendation to the JDC; (ii) providing guidance on regulatory activities for recommendation to the JDC; (iii) preparing joint deliverables, including updates to the Global Development Plan for submission to the JDC; (iv) preparing study protocols and statistical analysis plans for approval in accordance with Section 3.3.2(b); (v) preparing regulatory documentation for recommendation to the JDC; (vi) proposing goals, budgets and timelines for joint Development activities to the JDC; (vii) driving execution and ensuring the progress of Development activities in accordance with the Global Development Plan; and (viii) such additional matters as may be determined by the JDC. The Project Team shall act by consensus, with each Party’s representatives on the Project Team having collectively one vote. If the Project Team cannot reach consensus, the matter will be referred to the JDC for resolution. [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Table of Contents.

Appears in 1 contract

Sources: Joint Development and Commercialization Agreement (Vertex Pharmaceuticals Inc / Ma)

Formation; Responsibilities. The Partnership Parties will establish a project team (the “Project Team”) to oversee and coordinate activities under the Global Development PlanPlan for each Collaboration Product (and related Collaboration Product Candidate). Each of Sirius-US and CRISPR will be responsible for designating its own project leads (each, a “Project Leader”). The Project Team will include members be determined by the Project Leaders based on available personnel from each function identified on Schedule C-1Partnership Party across each function. The initial Project Team members for the Initial Collaboration Product are set forth on Schedule C-22.6. 1. If a Project Team member is no longer available to serve on the Project Team, the Parties will meet and discuss an appropriate replacement for applicable Project Leader may substitute such Project Team member from either upon prior written notice to the other Partnership Party, taking into account each Party’s expertise and resources in the relevant functional area. The appointment of the replacement Project Team member will require the JDC’s approval. Any member of the Project Team who is not dedicated to the Products under this Agreement on a full-time basis must be sufficiently dedicated to such Products to permit such person to will be reasonably and consistently available to participate in the activities of the Project Team. The Project Team will be responsible for: (ia) defining clinical and regulatory strategic options for recommendation to the JDCJXC; (iib) providing guidance on regulatory activities for recommendation to the JDCJXC; (iiic) preparing joint deliverables, including updates to the Global Development Plan for submission to the JDCJXC; (ivd) preparing study protocols and statistical analysis plans for approval in accordance with Section 3.3.2(bSections 3.1.2(b) and 3.1.2(d); (ve) preparing regulatory documentation for recommendation to the JDCJXC; (vif) proposing goals, budgets and timelines for joint Research and Development activities for Collaboration Product Candidates and Collaboration Products to the JDCJXC; (viig) driving execution and ensuring the progress of Research and Development activities for Collaboration Product Candidates and Collaboration Products in accordance with the Global Development Plan; and (viiih) such additional matters relating to Research and Development of Collaboration Product Candidates and Collaboration Products as may be determined by the JDCJXC. The Project Team shall act by consensus, with each Partnership Party’s representatives on the Project Team having collectively one vote. If the Project Team cannot reach consensus, the matter will be referred to the JDC JXC for resolution. [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Table of Contents.

Appears in 1 contract

Sources: Collaboration, Option and License Agreement (CRISPR Therapeutics AG)