Formation; Responsibilities Sample Clauses

Formation; Responsibilities. As soon as practicable after the Effective Date, the Scientific Program Board shall be formed to (i) provide advice on the direction and performance of the Program Activities that make up the HRP Initiative; (ii) propose and design Program Activities for submission to and the approval of the JSC; (iii) propose such additional scientific subcommittees as may be necessary to achieve the objectives of any Program Activity for submission to and the approval of the JSC; (iv) identify any public disclosure needs related to the HRP Initiative and develop scientific disclosure and publication materials for approval by the JSC; and (v) review and present to the JSC all Project Inventions. The SPB shall use reasonable efforts to reach agreement on any and all matters; provided, that, in the event that the SPB is unable to resolve any matter before it, such matter shall be referred to the JSC for resolution. BGM shall give good faith consideration to the advice of the SPB with respect to the conduct of all Program Activities; provided, that BGM shall at all times adhere to the requirements of the HRP Program in the performance of the HRP Initiative.

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

Formation; Responsibilities. Within [**], the Parties shall establish a joint steering committee (the “JSC”), composed of three (3) (or a larger number agreed by the Parties) senior representatives of each Party or its Affiliates. The JSC shall: (a) oversee the Arvinas Clinical Trial Activities and facilitate communications between the Parties with respect to such activities; (b) review, discuss and determine whether to approve amendments to the Arvinas Development Plan [**], including any amendments to effect changes to the clinical trial protocol for, design, timing or cost of the Arvinas Clinical Trials; (c) discuss all Data and other results arising from the Arvinas Clinical Trial Activities; (d) discuss planned activities to be undertaken in connection with the Arvinas Clinical Trial Activities and the anticipated timeline for initiating, transferring (where applicable) and completing such activities; (e) coordinate and oversee the delivery of the Handover Packages to Novartis pursuant to Section 2.5(b) and the other transfer and transition activities undertaken pursuant to Section 2.5; (f) review, discuss and make substantive decisions regarding all safety and pharmacovigilance issues arising out of the Arvinas Clinical Trial Activities; (g) coordinate and oversee the Manufacturing Technology Transfer in

Formation; Responsibilities. Within [**] after the Effective Date, the Parties will establish a joint steering committee (the “Joint Steering Committee” or “JSC”) to direct and oversee the Parties’ activities under this Agreement. The JSC will hold its first meeting within [**] after the Effective Date. Without limiting the foregoing, the JSC will have the responsibility and authority to: (a) encourage and facilitate ongoing communication and cooperation between the Parties with respect to the Exploitation of Licensed Products in the Field in the Territory; (b) review, discuss and approve any Solid Development Plan and Solid Budget or proposed amendment thereto; (c) review and approve each Option Territory Development Plan and Option Territory Development Budget; (d) solely during the applicable Development Option Period, review and approve each Party’s proposed updates and amendments to each Option Territory Development Plan; (e) review and approve each Option Territory Commercialization Plan and Option Territory Commercialization Budget;

Formation; Responsibilities. Within [**] after the first Solid Exercise Effective Date (if any), the Parties will establish a joint finance committee (the “JFC”) to coordinate the financial reporting by the Parties with respect to the funding of Option Territory Development Costs for Option Products and, if applicable, implementation of the Cost/Income Sharing Terms. Without limiting the foregoing, the JFC will have the responsibility and authority to: (a) reconcile financial and accounting matters between the Parties; (b) initiate and execute an effective and efficient revenue and cost sharing process (cross-charges); (c) discuss proposed changes to the FTE Rate; (d) cooperate to ensure that the Option Territory Commercialization Budget (including a template for converting gross amounts to net amounts) agreed to for a Calendar Year (or any other given period) can be interpreted for the purposes of both Parties’ internal financial and audit reporting requirements, including each Party’s fiscal year reporting;

Formation; Responsibilities. The Project Committee for this Project Agreement (the “Clinical Study Project Committee”) shall oversee and coordinate the conduct of the Clinical Study, including to: (a) [***]; (b) [***]; (c) [***]; (d) [***]; (e) [***]; (f) [***]; (g) [***]; (h) [***]; and (i) [***].

Formation; Responsibilities. The Project Committee for this Project Agreement (the “Combination Project Committee”) shall oversee and coordinate the conduct of the Research Program, including to: (a) oversee and coordinate the progress of the Research Program against the Research Plan and any timelines set forth therein; (b) review and approve amendments to the Research Plan; (c) discuss the Parties’ Research Program Reports, as contemplated by Section 4.4.2; (d) review and approve amendments to the Protocol, as contemplated by Section 6.1; (e) review and approve the final ICF, as contemplated by Section 6.2; (f) review and discuss the principal issues raised in each material communication with Regulatory Authorities with respect to the Combination Therapy, as contemplated by Section 7.2.2; (g) review and discuss the publication of any Combination Therapy Data pursuant to Section 6.6.2; (h) raise relevant topics or identify decisions to be made and, to the extent required under the Research Plan, bring expert recommendations to the attention of JSC; and (i) fulfill such other responsibilities as may be allocated to the Combination Project Committee under this Project Agreement or by mutual written agreement of the Parties. Notwithstanding Sections 2.3, 4.1.4 and 4.2.4 of the CLA, if the Combination Project Committee is unable to reach consensus with respect to a particular matter within [**] after the matter is first presented to the Combination Project Committee, then (a) Moderna shall [**], (b) Immatics shall [**], (c) with respect to [**].