Responsibilities of the Joint Steering Committee Sample Clauses

Responsibilities of the Joint Steering Committee. The JSC shall be responsible for (a) planning and supervising research and development under this Agreement, including establishing, reviewing and recommending modifications and updates to the Research Plans; (b) receiving and reviewing all data and other information obtained by either Party in connection with the Research Program and monitoring and reporting to the Parties on activities conducted pursuant to the Research Plans; (c) documenting and approving initiation and completion of each Research Project and the achievement of any Technical Milestones, Development Milestones and Sales Milestones; (d) evaluating FTE requirements for the performance of the Research Plans; and (e) such other functions as expressly specified hereunder or as agreed by the Parties.
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Responsibilities of the Joint Steering Committee. The Joint Steering Committee shall be responsible for the supervision and overall execution of all Research Projects under the Research Program. In particular the Joint Steering Committee shall be responsible for
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Responsibilities of the Joint Steering Committee. (a) In general, the responsibilities of the JSC will be to analyze, consult, review and advise MMT, solely on a non-binding, advisory basis, concerning the research, development, record keeping and other activities related to any Lead Drug, PDT Drug, PDT Device, PDT Therapy or the Pre-Clinical Development Program. As part of its responsibilities, the JSC will review and make non-binding recommendations as necessary from time to time concerning MMT's Pre-Clinical Development Program and Phase I Trial. Specific review and consulting activities for JSC include, but are not limited to, (i) recommending guidelines for staffing physician advisory groups, Pre-clinical Development Program Plans, and Phase I Trial plans, (ii) discussing project projections, budgets, tracking reports, and timelines, (iii) reviewing and discussing data from pre-clinical studies and clinical trials, (iv) recommending additional research studies beyond Pre-clinical Development Program Plans, (v) recommending timing of and content for the INDA submission program with respect to any Lead Drug, PDT Drug, PDT Device or PDT Therapy in the Therapeutic Field, (vi) recommending content for the clinical readiness review, (vii) analysis of the Phase I Trial Report, and (viii) recommending how to amend, as needed, the Pre-clinical Development Program and Phase I Trial plans.
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Responsibilities of the Joint Steering Committee. In addition to the other functions and responsibilities of the Joint Steering Committee provided for in this Agreement, the Joint Steering Committee shall perform the following functions, subject to compliance with Section 2.4 in all respects:
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Responsibilities of the Joint Steering Committee. The Joint Steering Committee shall be responsible for directing, coordinating and supervising the research activities of the Parties during the Research Phase and the co-Development of Biontech Option Products, Sanofi Option Products and Sanofi Option Combination Products. In particular, the Collaboration and License Agreement Main Body Joint Steering Committee shall (i) review and update the Research Plan; (ii) receive regular reports from each Party’s Alliance Manager on, and monitor the conduct, progress and results of each Party’s activities under the Research Plan; (iii) oversee and manage the work under, monitor the progress of, and implement any Development plan according to Section 4, including compliance with budget and timelines; (iv) review quarterly Manufacturing information produced in accordance with Section 3.3.6, including forecasts of clinical supplies requirements for the co-Development of Biontech Option Products, Sanofi Option Products and Sanofi Option Combination Products; (v) discuss and exchange information regarding the conduct of ongoing clinical trials; (vi) resolve any issues referred to it by the Parties in accordance with Section 13.7; and (vii) from time to time, establish one or more subcommittees or project teams to oversee particular projects or activities, as the JSC deems necessary or advisable. For the avoidance of doubt, the Joint Steering Committee shall not have any responsibilities with respect to Sanofi’s Development and Commercialization of Licensed Products.
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Responsibilities of the Joint Steering Committee. At each quarterly meeting of the JSC, the Parties, through their representatives on the JSC, shall be required to submit a report to the other members of the JSC on their respective activities for the prior calendar quarter setting forth their progress and specific activities undertaken in accordance with the Work Plan. In general, the JSC shall be responsible for reviewing and reporting on the progress of the Project, ensuring the Project proceeds according to the timelines set forth in the Work Plan, ensuring the cooperation and participation of the Parties in the performance of the Project and reviewing the recommendations, plans and other activities in support of the Project and coordinating the activities of the Parties under this Agreement to assure that the Project is aligned with the clinical development of the Product in the Territory. Subject to the other provisions of the Agreement, the JSC shall be responsible for coordinating the activities and decision-making of the Parties with respect to the approval of amendments to the Work Plan and all regulatory activities with respect to the Product as described further below. The following decisions shall require approval of the JSC (which approval shall not be unreasonably withheld or delayed):
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Responsibilities of the Joint Steering Committee. The JSC shall be responsible for reviewing and providing input on and, if expressly specified in this Agreement, approving the overall strategy of the Parties under this Agreement, including development plans and strategies, and for reviewing the Commercialization Program. Specifically, the JSC shall perform the following functions:
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Responsibilities of the Joint Steering Committee. In addition to the responsibilities expressly described elsewhere in this Agreement, the JSC shall:
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Responsibilities of the Joint Steering Committee. (a) The Joint Steering Committee shall monitor the activities of each Detailed Development Plan. In particular, the responsibilities of the Joint Steering Committee shall include: (a) determining whether or not the criteria for continued development under a particular Detailed Development Plan have been met; (b) defining the Target Dossier in accordance with Section 1.91; (c) approving the Detailed Development Plan for each Selected Collaboration Combination and Selected Licensed Combination; (d) planning, reviewing and approving preclinical and clinical study designs; (e) planning, reviewing and approving the timelines to complete such studies, including any amendments to the timeline necessitated by Permitted Delays; (f) ensuring that clinical Phase I and Phase II studies, in accordance with the Target Dossier, are designed such that results from such studies can be used to initiate Phase III Studies in the United States and Europe; (g) approving formulation technologies and license terms, as appropriate, for developing commercial formulations to be used to conduct the Phase III Studies for treating FOE Disease and/or BOE Disease; (h) ensuring proper communication between the Parties; and (i) recommending to the CEOs of each Party adjustments to any deadlines described in the Development Plans, in the event such adjustments are needed.
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Related to Responsibilities of the Joint Steering Committee

  • Responsibilities of the Parties 7.1. Rostelecom and the User bear responsibility for non-fulfillment or improper fulfillment of their responsibilities in the Agreement in accordance with the current law of the Russian Federation, (including the Regulations) and the Agreement.

  • Joint Steering Committee [***] following the Effective Date [***], a joint steering committee (the “JSC”) will be established by the Parties to provide oversight and to facilitate information sharing between the Parties with respect to the activities under this Agreement.

  • Steering Committee Each Party shall name a mutually agreed upon equal number of representatives for the Steering Committee, which shall meet twice per calendar year, or as otherwise mutually agreed by the Parties. In the event that a Steering Committee dispute cannot be resolved, such dispute shall be escalated to a senior executive of each of Customer and Lonza. The primary function of the Steering Committee is to ensure the ongoing communication between the Parties and discuss and resolve any issues arising under this Agreement. In addition to the primary function described above, the Steering Committee shall also take on the following responsibilities:

  • Development Committee As soon as practicable, the Parties will establish a joint development committee, comprised of at least one (1) and up to two (2) representatives of Omega and at least one (1) and up to two (2) representatives of Acuitas (the “JDC”). One such representative from each Party will be such Party’s Workplan Leader. Each Party may replace its Workplan Leader and other JDC representatives at any time upon written notice to the other Party, provided, however, that each Party shall use reasonable efforts to ensure continuity on the JDC. With the consent of the other Party (which will not be unreasonably withheld, conditioned or delayed), each Party may invite non-voting employees and consultants to attend JDC meetings as necessary, subject to consultant’s agreement to be bound to the same extent as a permitted subcontractor under Section 3.1(i).

  • Responsibilities of Adviser Without limiting the generality of the foregoing, the Adviser shall, during the term and subject to the provisions of this Agreement:

  • Joint Responsibilities In performing the Development Efforts, each party shall

  • Alliance Managers In addition to the foregoing governance provisions, each of the Parties shall appoint a single individual to serve as that Party’s alliance manager (“Alliance Manager”). The role of each Alliance Manager will be to participate and otherwise facilitate the relationship between the Parties as established by this Agreement. A Party may replace its Alliance Manager from time to time upon written notice to the other Party.

  • Project Team 6.1.1 The day-to-day responsibilities of the Parties with respect to this AGREEMENT shall be overseen by the PROJECT TEAM, which shall be responsible for deciding operational and scientific issues arising out of this AGREEMENT and unanimously agreeing in good faith with respect to the monitoring of the compliance with this AGREEMENT.

  • Activities of the Local Manager The services of the Local Manager to the Fund are not to be deemed to be exclusive, the Local Manager and any person controlled by or under common control with the Local Manager (for purposes of this Article V referred to as “affiliates”) being free to render services to others. It is understood that Directors, officers, employees and shareholders of the Fund are or may become interested in the Local Manager and its affiliates, as directors, officers, employees and shareholders or otherwise and that directors, officers, employees and shareholders of the Local Manager and its affiliates are or may become similarly interested in the Fund, and that the Local Manager and directors, officers, employees, partners and shareholders of its affiliates may become interested in the Fund as shareholders or otherwise.

  • Development Responsibilities From and after the Effective Date, BMS shall assume sole responsibility for the Development of Compounds and Products in the Field in the Territory during the Term at its own cost and expense (including responsibility for all funding, resourcing and decision-making, subject to Sections 3.3 and 3.4), except with respect to the performance by Ambrx of the Research Program activities assigned to Ambrx pursuant to the Research Plan and as otherwise may be agreed upon by the Parties in writing. BMS, by itself or through its Affiliates and Sublicensees, shall use Diligent Efforts to Develop a Compound or Product in the Field in accordance with the Development Plan for the purpose of obtaining a Regulatory Approval in each Major Market. For clarity, it is understood and acknowledged that Diligent Efforts in the Development of Compounds and Products may include sequential implementation of Clinical Trials and/or intervals between Clinical Trials for data interpretation and clinical program planning and approval.

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