Medical Affairs Strategy Sample Clauses

Medical Affairs Strategy. Hospira shall have the exclusive right to control, and shall use Commercially Reasonable Efforts to conduct, the comprehensive strategy of all medical affair matters relating to Product (the “Medical Affairs Strategy”), including with respect to (i) the preparation of any publication based on data and other information relating to any trial or study with respect to Product, or (ii) the planning and implementation of congress participations, medical education and/or key opinion leaders (KOL) or advisory board meetings with respect to Product. Except as otherwise set forth herein, Hospira shall bear the expense with respect to the Medical Affairs Strategy.
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Medical Affairs Strategy. The JMC shall develop a global Medical Affairs strategy for all Products throughout the world, including with respect to Medical Education Materials (the “Medical Affairs Strategy”). At least [**] during the Term (or more frequently as may be required or as may be reasonably requested by either Party), the JMC shall review and update the Medical Affairs Strategy based on currently available information and data. The JMC shall review, discuss, and determine whether to approve any such update to the Medical Affairs Strategy, and shall submit to the JEC to review, discuss, and determine whether to approve each such update to the Medical Affairs Strategy that is material. Each such update to the Medical Affairs Strategy will become effective and will supersede the previous Medical Affairs Strategy upon approval thereof by the JMC, and, if applicable, JEC. Sobi shall be responsible for Medical Affairs in connection with Products in the Sobi Territory, and Apellis shall be responsible for Medical Affairs in connection with Products in the Apellis Territory. Each Party shall conduct all Medical Affairs activities for the Products based on and materially consistent with the Medical Affairs Strategy. The Medical Affairs Strategy shall be compliant with all Applicable Laws and each Party’s written compliance policies and procedures and will address, without limitation, all matters identified in the definition of “Medical Affairs.”
Sample 1
Medical Affairs Strategy. NT Pharma shall have the exclusive right to control, and shall use Commercially Reasonable Efforts to conduct, a comprehensive strategy of all medical affairs matters relating to Product in the Territory (the “Territory Medical Affairs Strategy”), including with respect to (i) the preparation of any publication based on data and other information relating to any trial or study with respect to Product in the Territory, or (ii) the planning and implementation of congress participations, medical education programs and key opinion leader or advisory board meetings with respect to Product in the Territory. NT Pharma shall bear the expense with respect to conducting the Territory Medical Affairs Strategy.
Sample 1
Medical Affairs Strategy. Subject to Clause 3.1, NT Pharma shall have the exclusive right to control, and shall use Commercially Reasonable Efforts to conduct, a comprehensive strategy of all medical affairs matters relating to Product in the Territory (the “Territory Medical Affairs Strategy”), including with respect to (i) the preparation of any publication based on data and other information relating to any trial or study with respect to Product in the Territory, or (ii) the planning and implementation of congress participations, medical education programs and key opinion leader or advisory board meetings with respect to Product in the Territory. NT Pharma shall bear the expense with respect to conducting the Territory Medical Affairs Strategy.
Sample 1

Related to Medical Affairs Strategy

  • Regulatory Affairs Development and production of medical products and processes fall under the purview of the Food and Drug Administration (FDA) and research on these products involving animal or human studies is regulated by other laws, directives, and regulations. Project Awards under this Agreement that involve work in support of or related to FDA regulatory approval will address contingencies for Government access to regulatory rights in the event of product development abandonment or failure. Efforts conducted under this OTA shall be done ethically and in accordance with all applicable laws, directives, and regulations. The Government shall ensure performance includes regulatory expertise and guidance for candidate medical countermeasure development efforts:

  • Clinical Development Licensee will have sole responsibility for and sole decision making over the clinical development of any Product arising from the Research Program in the Field. Notwithstanding the foregoing, if Licensee wishes to conduct clinical development of a Development Candidate at Penn and Penn has the clinical expertise, interest and ability to run such a trial as assessed at Penn’s sole discretion, such a study will be conducted under a separate Clinical Trial Agreement to be negotiated by the Parties prior to initiation of such study. Such separate clinical trial agreement will include a detailed clinical development plan, including costs and time lines for conducting the Clinical Trial.

  • Business Development Provide advice and assistance in business growth and development of Party B. 业务发展。对乙方的业务发展提供建议和协助。

  • Promotion and Marketing For the purpose of promotion and marketing, the Borrower hereby authorizes and consents to the reproduction, disclosure and use by the Lenders and the Agent of its name, identifying logo and the Facilities, provided that the amount of Facilities shall not be disclosed. The Borrower acknowledges and agrees that the Lenders shall be entitled to determine, in their sole discretion, whether to use such information; that no compensation will be payable by the Lenders or the Agent in connection therewith; and that the Lenders and the Agent shall have no liability whatsoever to it or any of its employees, officers, directors, affiliates or shareholders in obtaining and using such information as contemplated herein.

  • Initial Development Plan Not later than the Effective Date, Licensee shall have provided Merck with an initial Development plan for the Licensed Product in the Field in the Territory, which shall be incorporated as part of this Agreement as Attachment 3.02(a) (as may be amended in accordance with this Agreement, the “Development Plan”). **CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

  • 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:

  • Research and Development (i) Advice and assistance in relation to research and development of Party B;

  • Strategic Planning Facilitate the effective alignment of IT requirements/ Information Resource Management (IRM) plans with strategic business plans and program initiatives. Management Improvements: Development and implementation of improved systems and business practices to optimize productivity and service delivery operations (e.g., analysis, and implementation of improvements in the flow of IT work and program processes and tool utilization, including business system analysis, identification of requirements for streamlining, re-engineering, or re-structuring internal systems/business processes for improvement, determination of IT solution alternatives, benchmarking).

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.

  • Program Management 1.1.01 Implement and operate an Immunization Program as a Responsible Entity

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