Responsibilities of the Steering Committee. The Steering Committee shall have the authority to make decisions in respect of those matters that, by the express terms of this Agreement, are to be addressed by the Steering Committee. In addition to any other matter that, by the express terms of this Agreement to be determined by the Steering Committee, the Steering Committee shall responsible for each of the following matters: [(1) developing and approving the initial Detailed Project Description for the Project (such Detailed Project Description to be developed in accordance with, and set forth the information specified in, Section 4(a)(ii)(B) of this Agreement);] [DELETE THIS PROVISION IF THE INITIAL DETAILED DESCRIPTIONS ARE ATTACHED AS APPENDICES TO THE AGREEMENT] (2) on at least a [monthly] [MODIFY AS APPROPRIATE BASED UPON FREQUENCY OF STEERING COMMITTEE MEETINGS] basis, developing and approving a revised Detailed Project Description for the Project for the [three-] [MODIFY AS APPROPRIATE BASED UPON FREQUENCY OF STEERING COMMITTEE MEETINGS] month period beginning on the date such Detailed Project Description is approved by the Steering Committee (each such Detailed Project Description to be developed in accordance with, and set forth the information specified in, Section 4(a)(ii)(B) of this Agreement); (3) overseeing the coordination, implementation and conduct of the Project in accordance with the Project Description; (4) reviewing the status and progress of the conduct of the Project; (5) determining if changes are needed to the scope of the Project; (6) implementing any changes to the scope of the Project that have been approved by the Parties; (7) reviewing and discussing the Invention Notices (as defined in Section 8(c)(i) of this Agreement) in respect of the Project Intellectual Property; (8) reviewing and discussing the filing of any patent applications in respect of any Patentable Project Intellectual Property; (9) reviewing and discussing the Project Deliverables, Project Results and such other matters related to this Agreement and the Research as are reasonably requested by either of the Parties; and (10) facilitating on-going communications between the Parties.
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:
(a) exchange of information and facilitation of cooperation and coordination between the Parties as they exercise their respective rights and meet their respective obligations under this Agreement;
(b) perform such other functions as appropriate to further the purposes of this Agreement, as determined by the mutual agreement of the Parties;
(c) with the exception of the Approval application that Cellegy has already submitted in Sweden, prior to submitting any Approval application, the Steering Committee shall discuss the scope and content of such Approval application. The Steering Committee may review and comment on all Approval applications, and such comments will be considered by the Parties as long as such comments are provided in a timely manner. In the event of a dispute within the Steering Committee or between the Parties directly or indirectly relating to the choice of countries within the Territory where Approval applications shall be filed and Approvals shall be obtained then clause 4.3 shall not apply. Licensee shall have final decision-making authority with respect to such Approval application issues; however, any such decisions shall be based on Licensee’s good faith belief that such decision is consistent with commercialization requirements of the Territory; and
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:
(i) Selecting which potential Projects will be advanced to the stage of performing Feasibility Work;
(ii) For any potential Project, drafting and agreeing upon an initial Statement of Work for carrying out the Feasibility Work for such potential Project, such Statement of Work to include, among other things, the scope of the Feasibility Work, which Party is to carry out the Feasibility Work (assuming a Primary Party has not been identified yet), where the Feasibility Work is to be performed, and allocation of costs between the Parties
(iii) identifying which Party shall be the Primary Party and which Party shall be the Secondary Party, provided that if a potential Project is initiated by a Party in response to actual or potential collaboration with a Third Party, then such Party shall be the Primary Party with respect to such Project;
(iv) drafting and agreeing upon the various Statement(s) of Work for carrying out the Project,
(v) allocating the financial responsibility(ies) for performing such Project among the Primary and Secondary Parties, and
(vi) selecting which, if any, Joint Cell Lines and/or Joint Products shall be pursued as part of such Project. Each Project shall continue unless and until terminated by the Primary Party, provided that the Secondary Party shall have the right to exercise its option, as set forth in Article 4, for any Project which the Primary Party elects to discontinue. The Program shall continue for the later of three (3) years or until the last to expire Project.
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.
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. 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:
a) review and approve strategies for the Preclinical Assessments of any Combination Products;
b) review and approve the Preclinical Assessment Plan and Budgets, including the allocation of work and responsibilities between the Parties, and authorize necessary amendments thereto;
c) determine whether a Preclinical Assessment Plan has been completed with respect to each Development Candidate;
d) monitor the conduct, progress and results of each Party’s activities under the Preclinical Assessment Plans;
e) agree in advance, review and approve the Costs that the Parties are entitled to incur under the Preclinical Assessment Plans; and
f) serve as the initial forum for the settlement of disputes or disagreements;
g) selection and designation of Collaboration Targets;
h) selecting the Lead IP Party for prosecution of Joint IP under Section 5.5.3. The Steering Committee shall have no authority to amend or modify the terms and conditions of this Agreement.
Responsibilities of the Steering Committee. In addition to the responsibilities expressly described elsewhere in this Agreement, the Steering Committee shall:
(a) design, prepare and finalize Development Plans for development of a Product for an Indication, including formulating the clinical development strategy, designing each clinical trial protocol and any modification thereto and agreeing upon the primary and secondary endpoints for all clinical trials of Product for all Indications conducted as part of the Collaboration;
(b) on an annual basis during any Development Plan Term, no later than October 1 of the relevant calendar year, review, amend, and approve each Development Plan and respective budget;
(c) oversee and monitor each Development Plan and coordinate and direct the strategy and management of the Development Plans;
(d) review and evaluate progress under any Development Plan; provided that the Steering Committee shall not have the authority to make any determination that either Party is in breach of its obligations under the Development Plan;
(e) serve as the initial forum for discussion of and resolution of any dispute or disagreement between the Parties relating to any Development Plan that is unresolved by the Primary Contact Persons;
(f) except with respect to intellectual property matters set forth in Article 8, decide how the Parties shall resolve or defend against disputes or claims of any kind with Third Parties relating to the Collaboration;
(g) establish any subcommittees pursuant to Section 2.1.1 and resolve any dispute or disagreement arising in any such subcommittee; and
(h) perform any other activities related to the Collaboration as the Parties may agree from time to time, other than deciding that a Party is in breach of an obligation under this Agreement.
Responsibilities of the Steering Committee. The Steering Committee will be responsible for, among other things:
(a) determining the overall strategy for the Collaboration in the manner contemplated by this Agreement;
(b) within [***] of the Effective Date, formulating a final Work Plan, which shall be attached to this Agreement as Exhibit F and may be amended from time to time by the Steering Committee;
(c) preparing a Project Plan and Project Budget for each Collaboration Product;
(d) coordinating, expediting, overseeing and controlling all development of Collaboration Products in the Field, including pre-clinical research, clinical research, manufacturing, regulatory filings and post approval development studies;
(e) monitoring, reviewing and directing the commercialization of Collaboration Products within the Field, including developing annual marketing and sales budgets, annual forecasts or sales and production requirements, an annual marketing plan, product positioning, creative campaign strategies, pricing and managed care contract strategies;
(f) evaluating additional technologies that may be necessary or beneficial to the Collaboration and recommending the acquisition or in-licensing of these technologies;
(g) addressing, financial issues which arise in connection with the Collaboration in the areas of accounting, cost allocation, budgeting and financial reporting
Responsibilities of the Steering Committee. 14.5.1 The Steering Committee will, subject to the Rules have the following functions, inter alia to:
14.5.1.1 oversee, facilitate, manage and monitor the operational implementation of the Works and take any remedial action if and when necessary;
14.5.1.2 review the progress of the Works/Works Program submitted to it for approval, evaluate and develop the feasibility of a proposed course of action and make recommendations to the Parties for the implementation thereof and provide advice on the improvement of the delivery of the Works;
14.5.1.3 review and consider the reports on the implementation and progress of the Works;
14.5.1.4 approve and certify correct the minutes of previous Steering Committee meetings;
14.5.1.5 keep a record in safe custody of the signed (or latest if not yet signed) version of this Agreement, and all amendments thereto, if any; and
14.5.1.6 do whatever else may be necessary to give full and proper effect to and to achieve the objectives of this Agreement.
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.
