Joint Medical Affairs Plan definition

Joint Medical Affairs Plan has the meaning set forth in Section 5.2.
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Joint Medical Affairs Plan has the meaning set forth in Section 5.6(c).
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Joint Medical Affairs Plan shall have the meaning set forth in Section 7.2. Section 1. 131 “Joint Medical, Development and Regulatory Committee” or “JMDRC” shall mean the WH JMDRC or Oncology JMDRC, as applicable.
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Examples of Joint Medical Affairs Plan in a sentence

  • In the event of any inconsistency between a Joint Medical Affairs Plan and this Agreement, the terms of this Agreement shall prevail.

  • The JSC shall approve those portions of the Joint Medical Affairs Plan which relate to global activities, but shall only review, and shall not approve, those portions of the Joint Medical Affairs Plan which relate only to activities specifically for the Licensed Territory or the Retained Territory.

  • The Joint Medical Affairs Plan with respect to a Licensed Product and subsequent revisions thereto shall contain such information as the JMAC believes necessary for the successful medical affairs support of such Licensed Product, both pre- and post-launch.

  • Once approved by the JSC, an amended annual Joint Medical Affairs Plan (including its corresponding Joint Medical Affairs Budget and Long Term Joint Medical Affairs Budget) will become effective for the applicable period on the date approved by the JSC (or such other date as the JSC will specify).

  • Any JSC-approved amended Joint Medical Affairs Plan (including its corresponding Joint Medical Affairs Budget and Long Term Joint Medical Affairs Budget) will supersede the previous Joint Medical Affairs Plan (including its corresponding Joint Medical Affairs Budget and Long Term Joint Medical Affairs Budget) for the applicable period.

  • The Parties shall agree upon the initial Joint Medical Affairs Plan (including the corresponding Joint Medical Affairs Budget), which shall be approved by the JMAC, no later than [*] after the Effective Date.

  • Unless the Parties agree in writing upon an alternate allocation of responsibility, (a) for the Profit-Share Territory, the Parties will have joint responsibility for all Medical Affairs Activities in support of the Licensed Products, with each Party serving as the Medical Affairs Lead Party as designated in the applicable Joint Medical Affairs Plan, as the same may be amended and expanded in accordance with Section 4.2.2 (Amendments to Joint Medical Affairs Plan).

  • The Parties agree to collaborate with respect to the Medical Affairs Activities in support of Products in the Field in the Shared Territory as provided in this Article 5 under the direction of the JMAC, and pursuant to the Joint Medical Affairs Plan applicable to each Product.

  • Each of Biogen and Sage will use Commercially Reasonable Efforts to carry out the tasks for which it is responsible for under the applicable corresponding Joint Medical Affairs Plan in accordance with the applicable timelines set forth in such plan.

  • Each such amended Joint Medical Affairs Plan will specify the items described in Section 4.2.1 (General) for each Product Class for the next Calendar Year (and additional periods as reasonably determined by the Parties) and the Joint Medical Affairs Budget included therein will appropriately itemize the FTE Costs and Out-of-Pocket Costs for the activities undertaken pursuant to such Joint Medical Affairs Plan.

Related to Joint Medical Affairs Plan

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Medical Affairs Activities means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Compounds or Licensed Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Licensed Product.

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Global Development Plan has the meaning set forth in Section 3.1.

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 3.4 (Joint Commercialization Committee).

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • Development Plan has the meaning set forth in Section 3.2.

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • Joint Development Committee or “JDC” has the meaning set forth in Section 3.10.

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

  • Project Management Plan means the portion of the Project Development Plan providing the information requested in Section 4.2 of Exhibit B to the ITP.

  • Quality Assurance Plan or “QAP” shall have the meaning set forth in Clause 11.2;

  • Technology Transfer Plan has the meaning set forth in Section 4.1.5.

  • Participating Clinical Professional Counselor means a Clinical Professional Counselor who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Development Program means the implementation of the development plan.

  • Redevelopment Plan means the “Lincoln Center Redevelopment Plan” passed, adopted and approved by the City pursuant to the Resolution, and shall include any amendment of said Redevelopment Plan heretofore or hereafter made by the City pursuant to law.

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Development Committee has the meaning set forth in Article 3 of the Amended and Restated Research and Development Agreement.

  • Non-Participating Clinical Professional Counselor means a Clinical Professional Counselor who does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Individual development account means a contract between an account holder and a fiduciary organization, for the deposit of funds into a financial institution by the account holder, and the deposit of matching funds into the financial institution by the fiduciary organization, to allow the account holder to accumulate assets for use toward achieving a specific purpose approved by the fiduciary organization.

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Marketing Plan has the meaning set forth in Section 4.3(a).