Regulatory Committee Sample Clauses

Regulatory Committee. Conor and Phytogen shall establish a committee (the “Regulatory Committee”), which will consist of [*] representatives, [*] of which shall be appointed by Conor, and [*] of which shall be appointed by Phytogen. The representatives of each party may be changed from time to time at the discretion of the party making such change. The Regulatory Committee shall meet in person or by teleconference from time to time during the term of the Agreement provided that at least [*] representatives are present. The Regulatory Committee shall be responsible for overseeing and reviewing regulatory and clinical plans for the Product and Conor Devices incorporating Product. The Regulatory Committee may provide guidance and/or make recommendations for such plans. All decisions of the Regulatory Committee shall be made by a majority of the representatives of the Regulatory Committee provided such majority includes at least one appointee of each party; provided, however, that if the Regulatory Committee is unable to reach a majority decision with respect to regulatory recalls of the Conor Device only, then Conor shall make the final decision as to such matter, subject to the provisions of Section 6.4 hereof.
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Regulatory Committee. The Regulatory Committee shall be responsible for (i) implementing the decisions made by the License Steering Committee, (ii) the optimal regulatory filing strategies for the Products, (iii) developing and implementing the regulatory plan for the Products, (iv) liaison activities with regulatory authorities during the development and initial file review through approval or registration in each country for the Products, (v) regulatory activities relating to the development, approval and registration of New Indications and Line Extensions for the Products and (vi) coordinating activities related to post-approval safety and surveillance of the Products. Within the Regulatory Committee, Sanofi shall have the Lead for Clopidogrel Products and BMS shall have the Lead for Irbesartan Products; provided, however, that, notwithstanding the above, all recommendations and decisions made by the Regulatory Committee shall be jointly made pursuant to Section 6.6(b) hereof. The Regulatory Committee shall report and make its recommendations to the License Steering Committee.
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Regulatory Committee. (a) The RC shall consist of regulatory, research and development, safety and marketing medical managers and such other relevant personnel (as needed) from each of Neurocrine and Pfizer, each of which shall confirm to the other its designees and which shall be responsible for the regulatory compliance of the Development Program in the US Territory. The specific responsibilities of the RC are set forth in Section 4.2.
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Regulatory Committee. The RC will operate within the framework of the governance structure set forth in Article 3. The responsibilities of the RC include, but are not limited to, the following:
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Regulatory Committee. The Regulatory Committee shall be responsible for (i) implementing the decisions made by the License Steering Committee, (ii) the optimal regulatory filing strategies for the Products, (iii) developing and implementing the regulatory plan for the Products, (iv) liaison activities with regulatory authorities during the development and initial file review through approval or registration in each country for the Products, (v) regulatory activities relating to the development, approval and registration of New Indications and Line Extensions for the Products and (vi) coordinating activities related to post-approval safety and surveillance of the Products. Within the Regulatory Committee, Sanofi shall have the * CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTION HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION Lead for Clopidogrel Products and BMS shall have the Lead for Irbesartan Products; provided, however, that, notwithstanding the above, all recommendations and decisions made by the Regulatory Committee shall be jointly made pursuant to Section 6.6(b) hereof. The Regulatory Committee shall report and make its recommendations to the License Steering Committee.
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Related to Regulatory Committee

  • Study Committee The parties shall utilize the Benefits Advisory Committee, with equal membership by the State and the VSEA, for the purpose of reviewing all issues related to health care and prescription drugs, and recommending changes to the bargaining committees. The parties shall also establish a special study committee to evaluate the current health plans, and make recommendations to the bargaining committees of the State and employees for sustainable savings in the health care plans.

  • Advisory Committee The Settling State shall designate an Opioid Settlement Remediation Advisory Committee (the “Advisory Committee”) to provide input and recommendations regarding remediation spending from that Settling State’s Abatement Accounts Fund. A Settling State may elect to use an existing advisory committee or similar entity (created outside of a State-Subdivision Agreement or Allocation Statute); provided, however, the Advisory Committee or similar entity shall meet the following requirements:

  • Advisory Committees The Board may appoint Advisory Committees to review design review applications, or provide input on other issues of concern to the Board or the Commission. These Advisory Committees include, but are not necessarily limited to, the following:

  • Development Committee As soon as practicable, the Parties will establish a joint development committee, comprised of up to [**] representatives of Verve and up to [**] 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, subject to their agreement to be bound to the same extent as a permitted subcontractor under Section 3.1(i).

  • Joint Commercialization Committee As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular:

  • Evaluation Committee A The Association and the Board agree to establish a standing joint Evaluation Development Committee for the purpose of establishing the procedure and process, including the evaluation instrument, for the evaluation of teachers in the District and to regularly review the effectiveness of the procedure and process, including the evaluation instrument, for the evaluation of teachers in the District.

  • Technical Committee 1. The Technical Committee shall comprise:

  • 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.

  • 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. The Recipient shall: • 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. Products: • List of Potential TAC Members • List of TAC Members • Documentation of TAC Member Commitment

  • Monitoring Committee The Monitoring Committee shall be established within six months of the signing of the Memorandum of Understanding. Its role is stipulated in the Regulation, in particular Article 4.4 thereof.

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