Responsibilities of the Steering Committee. The Steering Committee shall be responsible for directing, coordinating and supervising the Preclinical Assessment activities of the Parties hereunder. In particular, the Steering Committee shall:
Responsibilities of the Steering Committee. The Steering Committee will be primarily responsible for activities relating to implementation of the activities contemplated by this Agreement. The Steering Committee shall, subject to the provisions set forth in this Agreement (including the dispute resolution procedures hereof), be the primary vehicle for interaction between the Parties with respect to the Development and commercialization of the Licensed Product in the Territory. In particular, the Steering Committee shall perform the following functions:
Responsibilities of the Steering Committee. The Steering Committee shall be responsible for, among other things, (A) defining the subject matter, scope and specific content of each proposed research project; (B) developing and approving the General Research Project Description in respect of each proposed research project (such description to set forth the information specified in Section 3(a) of this Agreement); (C) developing and approving the initial Detailed Research Project Description in respect of each proposed research project (such description to set forth the information specified in Section 3(a) of this Agreement); (D) on a quarterly basis, developing and approving a revised Detailed Research Project Description in respect of each proposed research project for the next six months of each proposed research project (such description to set forth the information specified in Section 3(a) of this Agreement) (such revised Detailed Research Project Description to be approved at each regularly scheduled quarterly Steering Committee meeting); (E) determine if any of the ongoing Research Projects should be terminated; (F) determine if changes or additions are needed to any of the ongoing Research Projects; (G) implement any approved changes and additions to any of the ongoing Research Project; (H) developing and approving: (1) a list of the Foundation Provided Materials required to continue to conduct and complete each ongoing Research Project and (2) a list of the any Reimbursable Research Project Non-FTE Costs required to continue to conduct and complete each ongoing Research Project (including the amount and estimated cost thereof); (I) approve any other matter required by the terms of this Agreement to be approved by the Steering Committee; and (J) facilitate on-going communications between the Parties. Any matter which requires a decision by, or the approval of, the Steering Committee under this Agreement shall require the affirmative consent of each representative of the Steering Committee. At each meeting of the Steering Committee, one representative shall be appointed to record and distribute the minutes of such meeting to be circulated between the Parties within a period of two weeks after the respective meeting.
Responsibilities of the Steering Committee. For each potential Project or Project, as the case may be, the Steering Committee shall be tasked with at least the following action items:
Responsibilities of the Steering Committee. The Steering Committee shall, among other things, (A) develop and define the description and scope of each Project (including setting forth the number of Services FTEs to be designated to complete each such Project and the estimated timeframe to complete each such Project); (B) approve the number of Services FTEs to be designated to complete each such Project and the estimated timeframe to complete each such Project; (C) for each Project, approve the initial costs (and subsequent changes requested by the Project Managers) related to (1) Evotec Provided Reimbursable Materials, (2) Specialized Third Party Licenses and Services and (3) data collection related to the performance of Structural Biology Services requiring synchrotron data collection required for such Project in respect of each such Project; (D) oversee the coordination, implementation and performance of the Services in respect of the Projects; (E) review the status and progress of the Projects; (F) determine if changes are needed to the number of Services FTEs under this Agreement and submit any such changes to the Parties for consideration and approval; (G) review and discuss the Services Deliverables, Services Results and such other matters related to this Agreement and the Services as requested by either of the Parties; (H) develop and adopt or amend, as applicable, the CHD Registration Protocol the Compound Receipt, Handling and Storage Services Protocols and the Stored Compound Distribution Services Protocols and (I) facilitate on-going communications between the Parties.
Responsibilities of the Steering Committee. 14.5.1 The Steering Committee will, subject to the Rules have the following functions, inter alia to:
Responsibilities of the Steering Committee. In addition to the responsibilities expressly described elsewhere in this Agreement, the Steering Committee shall:
Responsibilities of the Steering Committee. The Steering Committee shall be responsible for the following decisions (“Major Decisions”):
Responsibilities of the Steering Committee. The Steering Committee will, among other things, (A) oversee the coordination, implementation and conduct of the Project; (B) review the status and progress of the Project; (C) determine if changes are needed to the Project; (D) implement any approved changes to the Project; (E) review and discuss the Project Results and such other matters related to this Agreement and the Project as requested by either of the Parties and (F) facilitate on-going communications between the Parties. Any matter which requires a decision by, or the approval of, the Steering Committee under this Agreement will require the affirmative consent of each representative of the Steering Committee. At each meeting of the Steering Committee, one representative will be appointed to record and distribute the minutes of such meeting to be circulated between the Parties within a period of two weeks after the respective meeting.
Responsibilities of the Steering Committee. Subject to Section 15.3, the duties and responsibilities of the Steering Committee shall include to: (i) review, comment and approve any Product Development of Licensed Products being conducted pursuant to Article II of this Agreement, including approval of associated budgets, provided, however, that any modification to a Product Development plan that is requested by a Regulatory Authority shall be deemed to have been agreed to by the Steering Committee and both Parties, provided, further, however, that any modification to a Product Development plan that is not requested by a Regulatory Authority shall need to be agreed in writing by both Parties; (ii) amend the Specifications for Licensed Products, as appropriate; provided, however, that any modification to the Specification that is not requested by a Regulatory Authority shall need to be agreed in writing by both Parties; (iii) review and approve launch plans and annual sales and marketing plans of Licensed Products prior to the implementation thereof; (iv) make determinations concerning whether to Commercialize and/or launch Licensed Products (including good faith consideration of any proposed initial, expedited launches of Licensed Product) in any country in the Territory, including review and approval of associated plans and budgets; (v) review and approve any packaging and marketing strategy; (vii) establish the Per Unit Price and the pricing under Section 6.1(c) for each Line Extension pursuant to Section 6.2; (vii) approve the publication of the results of any Product Development activities relating to Licensed Products pursuant to Section 7.3; and (viii) determine in which additional countries to file, prosecute and maintain one or more of the ANIKA Patents pursuant to Section 8.3. In connection with any meeting of the Steering Committee, the Parties will endeavor to provide to the other Party all materials in connection with this Section 15.4 at least five (5) Business Days in advance of such meeting. Notwithstanding anything to the contrary contained herein, ANIKA shall be responsible for the preparation of any Development plans and associated budgets for any Line Extension contemplated by Section 2.2.
