Joint Steering Committees Sample Clauses

Joint Steering Committees. The Parties shall form two joint steering committees (each, a “JSC”) to oversee, coordinate and review recommendations and approve decisions in respect of the matters set forth hereunder, one for research, development and Commercialization (the “Regulatory JSC”), and the other for ongoing regulatory matters, logistics and the like (the “Post-Commercialization JSC”).

Joint Steering Committees. Subject to the dispute resolution authority of the Executive Officers as set forth in Section 2.1, the WH JSC and the Oncology JSC shall have overall responsibility for monitoring and providing general operational oversight with respect to the Parties’ activities under this Agreement with respect to, respectively, the WH Product(s) and any Pediatric Product(s), if Developed, in the case of the WH JSC and the Oncology Product(s) in the case of the Oncology JSC. In particular, the WH JSC (with respect to the WH Product(s) and Pediatric Product(s)) or the Oncology JSC (with respect to the Oncology Product(s)) shall be responsible for: 2.3.1 overseeing the strategic operational aspects of the Development and Commercialization of the WH Product(s), or Oncology Product(s) (as applicable) in the Field and Territory pursuant to the applicable Joint Medical Affairs and Development Plan and Budget and Co-Promotion Commercialization Plan and Budget; 2.3.2 reviewing and discussing reports from the various Committees and other future Committees, and providing guidance thereto; 2.3.3 directing and overseeing the various Committees on all significant strategic issues that fall within the purview of the various Committees; 2.3.4 resolving matters presented to it by, and disputes raised to it by each JMDRC; each JCC, the JMC, the JFC, the IPOC, the Compliance Committee or any Working Group established by the applicable JSC; 2.3.5 reviewing and approving each update or change to the applicable Joint Medical Affairs and Development Plan and Budget proposed by the applicable JMDRC other than an amendment to the budget (which shall be governed by Section 2.3.10), including any such update or change to include any Product in the WH Field or Oncology Field other than the Products as they exist as of the Effective Date or a new women’s health or oncology indication for any Product; 2.3.6 reviewing the Pfizer Operation Plan and amendments thereto provided by Pfizer under Section 10.5.5; 2.3.7 reviewing and approving any Co-Administration Study for inclusion in the Joint Medical Affairs and Development Plan and Budget; 2.3.8 reviewing and approving the budget and resources in support of each protocol for each Clinical Trial or Other Study with respect to the Products in the Field in the Co-Promotion Territory and if needed amend the applicable Joint Medical Affairs and Development Plan and Budget to provide for such budget and resources; 2.3.9 reviewing and approving each update or...

Joint Steering Committees. Promptly, but not later than thirty (30) days following with Effective Date, the Parties shall form a joint coordination committee (“JSC”) to oversee, coordinate and review recommendations and approve decisions in respect of the matters set forth hereunder, including the overall strategy for Developing, supply and Commercializing the Licensed Product in Territory A, so as to maximize the commercial potential of the Licensed Product in Territory A while harmonizing such efforts with the Development and Commercialization of the Licensed Product outside of Territory A.

Joint Steering Committees. 3.1.1 The Parties will establish a separate committee (the “Joint Steering Committee” or the “JSC”) to review each Development Program and oversee progress of the activities conducted thereunder and facilitate the sharing of information among the Parties with respect to such activities. 3.1.2 Each JSC shall be comprised of [**] of Celgene USA, [**] of CIS, and [**] of Concert. Each Party shall make its designation of its Representatives for the [**] Products Development Program within [**] Business Days following the Effective Date and for the [**] Products, [**] Products and [**]Option Products Development Programs, promptly after the exercise of the applicable License Option with respect thereto. Each Party may substitute one or more of its Representatives, in its sole discretion, effective upon notice to the other Parties of such change. A Representative of a Party serving as a member of one JSC may serve on any or all of the other JSCs. Prior to First Phase 1 Completion, [**] Representative shall be the chairperson of each JSC. Following First Phase 1 Completion, [**] Representative shall be the chairperson of each JSC. 3.1.3 Each JSC shall meet within [**] days after the Effective Date, or at such further time as agreed by the mutual consent of the Parties, and, thereafter, [**]; provided that following the completion of the first Phase 1 Clinical Trial of a Licensed Product, Celgene may, upon written notice to Concert, reduce the number of such required meetings of the JSC with oversight of such Licensed Product to [**]. The chairperson of the JSC shall be responsible for calling meetings of the JSC and for leading the meetings. Each Party may have in attendance one or more other non-voting employees or other Representatives from time to time, by written consent of the Parties, with such consent not to be unreasonably withheld or delayed, subject to any such Representative’s written agreement to comply with requirements of confidentiality and non-use at least as stringent as those set forth in ARTICLE 9. The location of meetings of the JSC shall alternate between Celgene USA’s principal place of business and Concert’s principal place of business, or as otherwise agreed by the Parties. The JSC may also meet by means of a telephone conference call or videoconference. The chairperson may convene a special meeting of the JSC for the purpose of resolving disputes of the JSC. 3.1.4 The Parties shall each bear their own costs and expenses related to their p...

Joint Steering Committees