Joint Research and Development Committee Sample Clauses
Joint Research and Development Committee. 2.1.1 Within thirty (30) days after the Effective Date, the Parties shall establish a joint research and development committee (the “Joint Research and Development Committee” or “JRC”) to discuss program objectives and review data during the Term, and to monitor and to make certain decisions regarding the Initial Development Program, as set forth in this Section 2.1. The JRC shall have (i) reviewing, monitoring, and approving responsibilities for all Development activities performed by GlobeImmune under the Initial Development Program with respect to each Collaboration Compound and activities performed by GlobeImmune with respect to Future Programs, in each case, prior to the exercise of a Celgene Program Option by Celgene for such Collaboration Compound, and (ii) reviewing and monitoring, but not approving, responsibilities for all Development activities performed by Celgene under the applicable Development Plan with respect to each Celgene Development Compound after the exercise of a Celgene Program Option by Celgene for such Celgene Development Compound. The JRC shall also provide a forum for sharing advice, progress, and results relating to such activities and shall attempt to facilitate the resolution of any disputes between the Parties, as described in Section 2.1.3. The JRC shall be briefed by the Parties regarding the content, execution, and results achieved by the respective Parties under the Initial [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Development Program and Development Plan(s). Each Party, through its representatives on the JRC, shall be permitted to provide advice and commentary with respect to the Initial Development Program and Development Plan(s). Each Party shall take such advice and commentary into good faith consideration. More specifically, the JRC shall:
(a) modify, as applicable, plans for the conduct of the Initial Development Program on a Program-by-Program basis in accordance with Section 3.2.5;
(b) review and provide advice regarding the overall progress of GlobeImmune’s efforts to optimize and Develop Drug Candidates (and any Follow-On Compounds with respect to such Drug Candidate) in accordance with the Initial Development Program;
(c) review and provide advice regarding the overall progress of GlobeImmune’s efforts to discover, identify, optimize, and Develop Futu...
Joint Research and Development Committee. 3.1.1 Within thirty (30) days after the Effective Date, the Parties shall establish a joint research and development committee (the “Joint Research and Development Committee” or “JRC”) to discuss program objectives and review Data, and to monitor and to make certain decisions regarding the Collaboration Development Plan, as set forth in this Section 3.1. The JRC shall also provide a forum for sharing advice, progress, and results relating to such activities and shall attempt to facilitate the resolution of any disputes between the Parties, as described in Section 3.1.3. The JRC shall be briefed by the Parties regarding the content, execution, and results achieved by the respective Parties under the Collaboration Development Plan. Each Party, through its representatives on the JRC, shall be permitted to provide advice and commentary with respect to the Collaboration Development Plan. Each Party shall take such advice and commentary into good faith consideration. More specifically, subject, in each case, subject to the provisions of Section 3.1.3, the JRC shall:
(a) review and provide advice regarding the overall progress of each Party’s efforts to discover, identify, optimize and otherwise Develop Licensed Vaccines;
(b) [*];
(c) select Licensed Vaccine(s) for GlobeImmune Clinical Trials under the Collaboration Development Plan;
Joint Research and Development Committee. 2.1.1 In accordance with the terms and conditions set forth below, the Parties shall conduct the research and development of Development Candidates ("R&D WORK") pursuant to a mutually agreed plan approved (and as amended from time to time) in accordance with this Article 2, including, at a minimum and without limitation, the subject matter set forth in Exhibit C (the "R&D PLAN"). The R&D Work shall consist of the two phases: (a) the discovery or optimization of potential Development Candidates (the "RESEARCH WORK"), and (b) the development of select Development Candidates into New Products (the "DEVELOPMENT WORK").
2.1.2 Within ten (10) days after the Effective Date, each Party shall appoint three (3) individuals to serve as its representatives on a joint research and development committee (the "JRDC"). The JRDC shall formulate and approve the initial R&D Plan and, from time to time, any modifications or amendments thereto. The initial R&D Plan shall include, at a minimum and without limitation, the subject matter set forth in Exhibit C. The R&D Plan shall specify the R&D Work to be performed by the Parties and the Project Year Commencement Date therefor. Each Party shall have the right to change any or all of its representatives on the JRDC upon written notice to the other Party, provided that each Party shall appoint and maintain for the duration of the term of this Agreement at least one senior management representative on the JRDC.
2.1.3 The JRDC shall have authority over the design, management and conduct of the R&D Work and, if applicable, the commercialization of New Products. The JRDC may appoint individuals to serve as representatives on subcommittees to assist the JRDC with respect to any particular subject matter of the R&D Plan and, if applicable, the commercialization of New Products, including, for example, product manufacturing, quality control and assurance, preclinical studies design, implementation and evaluation, clinical protocols design, implementation and evaluation, and regulatory affairs. Without limiting the generality of the foregoing, the JRDC shall have the sole authority to: 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.
(a) Develop and implement the R&D Plan, including, without limitation, go/no-go criteria, timelines and responsibilities ...
Joint Research and Development Committee. The Parties hereby establish a joint research and development committee (the “JRDC”) to facilitate performance of the Research Program and discussion regarding the Development of Selected Compounds and to coordinate patent prosecution strategy with respect to Collaboration Intellectual Property. During the Research Term, each of Otsuka and MethylGene shall attend each meeting of and otherwise participate in the JRDC; thereafter, MethylGene shall have the right, but not the obligation, to attend meetings of and otherwise participate in such committee; provided, however, that, for the avoidance of doubt, MethylGene is not entitled to vote with respect to matters decided at meetings after the Research Term that it does not attend (and that, except as otherwise expressly provided in this Agreement, such matters may be decided by a majority of the JRDC representatives attending such meeting).
Joint Research and Development Committee. 2.1.1 Within thirty (30) days after the Effective Date, the Parties shall establish a joint research and development committee (the “Joint Research and Development Committee” or “JRC”) to discuss program objectives and review data during the Term, and to monitor and to make certain decisions regarding the Initial Development Program, as set forth in this Section 2.1. The JRC shall have (i) reviewing, monitoring, and approving responsibilities for all Development activities performed by GlobeImmune under the Initial Development Program with respect to each Collaboration Compound and activities performed by GlobeImmune with respect to Future Programs, in each case, prior to the exercise of a Celgene Program Option by Celgene for such Collaboration Compound, and (ii) reviewing and monitoring, but not approving, responsibilities for all Development activities performed by Celgene under the applicable Development Plan with respect to each Celgene Development Compound after the exercise of a Celgene Program Option by Celgene for such Celgene Development Compound. The JRC shall also provide a forum for sharing advice, progress, and results relating to such activities and shall attempt to facilitate the resolution of any disputes between the Parties, as described in Section 2.1.
Joint Research and Development Committee. The Parties hereby establish a joint research committee (the “Joint Research and Development Committee” or the “JRDC”).
Joint Research and Development Committee. The Parties shall establish a joint research and development committee (the “Joint Research and Development Committee” or the “JRDC”), composed three (3) representatives of each Party that have knowledge and expertise in the Field and in the development of products similar to the Licensed Products. The JRDC shall oversee the research and Development activities of the Parties under the Research Plan and the Development Plan and recommend amendments to the Research Plan (including the Research Budget) and Development Plan (including the Development Budget). Such activities shall include recommending to the JSC the choice of the Selected Licensed Products and Selected Biomarkers. The JRDC shall review, and approve the detailed protocols for the studies which are already included in the Research Plan or in the Development Plan.
Joint Research and Development Committee. The responsibilities of the Joint Research and Development Committee (“JRDC”) and Joint Management Committee (“JMC”) established by the R&D Collaboration Agreement shall be extended to apply to the IVD Collaboration. In furtherance of the foregoing, the provisions of Article 6 of the R&D Collaboration Agreement are incorporated herein and shall apply mutatis mutandis; provided, however, that Sections 6.1.2, 6.1.5.1, 6.1.5.2, 6.1.7, 6.3, and 6.7 of the R&D Collaboration Agreement shall not apply to this Agreement or any activities under the IVD Collaboration.
Joint Research and Development Committee. The Parties hereby establish a joint research committee (the “JRDC”) as a joint subcommittee under the JSC, composed of [***] (or a larger number agreed by the Parties) representatives of each Party, each of whom will have the appropriate experience and expertise to perform its responsibilities on the JRDC. The JRDC shall:
(a) coordinate the Collaboration and facilitate communications between the Parties with respect to the Collaboration;
(b) prepare a Research Plan (including the Research Budget set forth therein) for any Replacement Target named to the Collaboration after the Effective Date and submit such Research Plan to the JSC to review, discuss and determine whether to approve;
(c) on at least [***] basis during the Research Term in accordance with Section 2.2, prepare amendments to each Research Plan (including the Research Budget set forth therein) and submit the Research Plan to the JSC to review, discuss and determine whether to approve such amendment; 264814036 v4 EXECUTION COPY CONFIDENTIAL INFORMATION
(d) discuss the data and results of performance of the Research Plans and the anticipated timeline for initiating and completing the activities set forth therein; and
(e) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Research of the Products, as directed by the JSC.
Joint Research and Development Committee. The collaboration between Miles, Onyx, and their respective Affiliates under this Agreement shall be managed by a Joint Research and Development Committee (the “JRDC”). The size of the JRDC may be determined from time to time; initially it shall consist of six members, three each appointed by Onyx and Miles within ten days after the Effective Date. Members of the JRDC shall be composed of senior officers or representatives of each party authorized to make decisions with respect to matters within the scope of the JRDC’s authority. An alternate member designated by a Party may serve temporarily in the absence of a permanent member designated by such Party. Each Party shall appoint and replace its representatives to the JRDC, as appropriate during the collaboration. The JRDC shall operate by consensus. Any deadlock shall be referred to the designated executive officers of Miles and Onyx pursuant to Article 25 of this Agreement.