Joint Development Committee Authority and Decision-Making Sample Clauses

Joint Development Committee Authority and Decision-Making. (a) The JDC shall take action by unanimous consent, with each Party having a single vote, irrespective of the number of its representatives actually in attendance at a meeting. In the absence of a formal meeting, the Co-Chairs shall have decision-making authority for the JDC. In the case where the Co-Chair for a Party is not available, the Co-Chair may designate another JDC member (e.g. medical monitor) as having decision-making authority for the JDC for such Party. All decisions and approvals of the JDC shall be made, with acknowledgement of both Parties, in writing (such as by email exchange). Disputes at the JDC will be resolved in accordance with Section 2.8. (b) The JDC shall create a sub-team consisting of an equal number of representatives from each Party with appropriate functional area expertise to review and discuss substantive clinical operations issues related to Site Agreements, the CRO/Study Site List, ICFs and CRFs that arise in the course of the Combined Therapy Study (the “Clinical Operations Sub-Team”). The Clinical Operations Sub-Team will hold telephone discussions at mutually agreed-upon times to discuss any substantive issues and will use reasonable efforts to reach a mutually agreeable resolution as expeditiously as possible. The Clinical Operations Sub-Team, if mutually aligned (as acknowledged in writing by Clinical Operations Sub-Team representatives of both Parties, such as by email exchange), shall have the authority to approve substantive changes regarding an issue and will provide its decision to the Sponsoring Party. (c) The JDC shall have the right to make only those determinations expressly enumerated as decisions of the JDC in this Agreement or as otherwise specified in a Study Plan for a Sponsor-Funded Study. Such JDC determinations will be documented in the written minutes of the JDC signed or acknowledged as final via email by the JDC Co-Chairs. (d) In this Agreement where it is specified that review by the JDC is required, such review may be accomplished for a Party by a subgroup of one or more of the JDC members for such Party, or any subteam or other employees for such Party designated by the Co-Chair for such Party. [*] = 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. (e) In this Agreement where it is specified that documentatio...
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Related to Joint Development Committee Authority and Decision-Making

  • Committee Authority The Committee shall have all discretion, power, and authority to interpret the Plan and this Agreement and to adopt such rules for the administration, interpretation and application of the Plan as are consistent therewith. All actions taken and all interpretations and determinations made by the Committee in good faith shall be final and binding upon the Employee, the Company and all other interested persons, and shall be given the maximum deference permitted by law. No member of the Committee shall be personally liable for any action, determination or interpretation made in good faith with respect to the Plan or this Agreement.

  • Technical Advisory Committee (TAC The goal of this subtask is to create an advisory committee for this Agreement. The TAC should be composed of diverse professionals. The composition will vary depending on interest, availability, and need. TAC members will serve at the CAM’s discretion. The purpose of the TAC is to: • Provide guidance in project direction. The guidance may include scope and methodologies, timing, and coordination with other projects. The guidance may be based on: o Technical area expertise; o Knowledge of market applications; or o Linkages between the agreement work and other past, present, or future projects (both public and private sectors) that TAC members are aware of in a particular area. • Review products and provide recommendations for needed product adjustments, refinements, or enhancements. • Evaluate the tangible benefits of the project to the state of California, and provide recommendations as needed to enhance the benefits. • Provide recommendations regarding information dissemination, market pathways, or commercialization strategies relevant to the project products. The TAC may be composed of qualified professionals spanning the following types of disciplines: • Researchers knowledgeable about the project subject matter; • Members of trades that will apply the results of the project (e.g., designers, engineers, architects, contractors, and trade representatives); • Public interest market transformation implementers; • Product developers relevant to the project; • U.S. Department of Energy research managers, or experts from other federal or state agencies relevant to the project; • Public interest environmental groups; • Utility representatives; • Air district staff; and • Members of relevant technical society committees. • Prepare a List of Potential TAC Members that includes the names, companies, physical and electronic addresses, and phone numbers of potential members. The list will be discussed at the Kick-off meeting, and a schedule for recruiting members and holding the first TAC meeting will be developed. • Recruit TAC members. Ensure that each individual understands member obligations and the TAC meeting schedule developed in subtask 1.11. • Prepare a List of TAC Members once all TAC members have committed to serving on the TAC. • Submit Documentation of TAC Member Commitment (such as Letters of Acceptance) from each TAC member. • List of Potential TAC Members • List of TAC Members • Documentation of TAC Member Commitment

  • Decision Making The Joint Development Committee and Joint Commercialization Committee shall each act by unanimous agreement of its members, with each Party having one vote. If the Joint Development Committee or Joint Commercialization Committee, after [* * *] (or such other period as the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decision, then either Party may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve the issues. If Executive Officers cannot resolve such issue within [* * *] of referral of such issue to the Executive Officers, the resolution of such issue shall be as follows: (a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoing: (i) if Acceleron is the Developing Party and such issue relates to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall be determined by [* * *]; (ii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; and (iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and (b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without the prior written consent of each Party.

  • Authority of the Committee The Committee shall have full authority to interpret and construe the terms of the Plan and this Agreement. The determination of the Committee as to any such matter of interpretation or construction shall be final, binding and conclusive.

  • Joint Safety Committee (a) The Union and the Company shall cooperate in selecting one or more Safety Committees, which will meet at least once a month to consider all safety and occupational health problems. (b) The local Joint Safety Committee shall consist of equal representation from Company and Union. This Committee shall meet at least once a month to consider all safety and occupational health problems.

  • Technical Committee 1. The Technical Committee shall comprise: (a) nine experts representing different regions of the Agreement Area, in accordance with a balanced geographical distribution; (b) one representative from the International Union for Conservation of Nature and Natural Resources (IUCN), one from the International Waterfowl and Wetlands Research Bureau (IWRB) and one from the International Council for Game and Wildlife Conservation (CIC); and (c) one expert from each of the following fields: rural economics, game management, and environmental law. The procedure for the appointment of the experts, the term of their appointment and the procedure for designation of the Chairman of the Technical Committee shall be determined by the Meeting of the Parties. The Chairman may admit a maximum of four observers from specialized international inter- governmental and non-governmental organizations. 2. Unless the Meeting of the Parties decides otherwise, meetings of the Technical Committee shall be convened by the Agreement secretariat in conjunction with each ordinary session of the Meeting of the Parties and at least once between ordinary sessions of the Meeting of the Parties. 3. The Technical Committee shall: (a) provide scientific and technical advice and information to the Meeting of the Parties and, through the Agreement secretariat, to Parties; (b) make recommendations to the Meeting of the Parties concerning the Action Plan, implementation of the Agreement and further research to be carried out; (c) prepare for each ordinary session of the Meeting of the Parties a report on its activities, which shall be submitted to the Agreement secretariat not less than one hundred and twenty days before the session of the Meeting of the Parties, and copies shall be circulated forthwith by the Agreement secretariat to the Parties; and (d) carry out any other tasks referred to it by the Meeting of the Parties. 4. Where in the opinion of the Technical Committee there has arisen an emergency which requires the adoption of immediate measures to avoid deterioration of the conservation status of one or more migratory waterbird species, the Technical Committee may request the Agreement secretariat to convene urgently a meeting of the Parties concerned. These Parties shall meet as soon as possible thereafter to establish rapidly a mechanism to give protection to the species identified as being subject to particularly adverse threat. Where a recommendation has been adopted at such a meeting, the Parties concerned shall inform each other and the Agreement secretariat of measures they have taken to implement it, or of the reasons why the recommendation could not be implemented. 5. The Technical Committee may establish such working groups as may be necessary to deal with specific tasks.

  • Outage Authority and Coordination Developer and Connecting Transmission Owner may each, in accordance with NYISO procedures and Good Utility Practice and in coordination with the other Party, remove from service any of its respective Attachment Facilities or System Upgrade Facilities and System Deliverability Upgrades that may impact the other Party’s facilities as necessary to perform maintenance or testing or to install or replace equipment. Absent an Emergency State, the Party scheduling a removal of such facility(ies) from service will use Reasonable Efforts to schedule such removal on a date and time mutually acceptable to both the Developer and the Connecting Transmission Owner. In all circumstances either Party planning to remove such facility(ies) from service shall use Reasonable Efforts to minimize the effect on the other Party of such removal.

  • Decision-Making Authority BMS shall have the sole decision-making authority for the operations and Commercialization strategies and decisions, including funding and resourcing, related to the Commercialization of Products; provided that such decisions are not inconsistent with the express terms and conditions of this Agreement, including BMS’ diligence obligations set forth in Section 5.1.

  • Investment Decisions The Subadviser shall determine from time to time what investments and securities will be purchased, retained, sold or loaned by the Series, and what portion of such assets will be invested or held uninvested as cash.

  • Initial Decision Maker The Architect will serve as the Initial Decision Maker pursuant to Article 15 of AIA Document A201–2017, unless the parties appoint below another individual, not a party to this Agreement, to serve as the Initial Decision Maker.

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