Combined Major Market Medical Affairs Plan Sample Clauses

Combined Major Market Medical Affairs Plan. The JMAT shall prepare the first draft of the Combined Major Market Medical Affairs Plan for review and approval by the JSC at least [*] months prior to the first anticipated Launch of the Product in the Major Markets (as such date is reasonably projected by the JDC), and cover a period of [*] years ([*] year forecasted and [*] year projections). Once agreed by the JMAT, the JMAT shall recommend the Combined Major Market Medical Affairs Plan to the JSC for approval. The Combined Major Market Medical Affairs Plan shall be updated at least annually, and all updates and amendments shall be reviewed and approved by the JMAT and then submitted to the JSC for approval. The Parties shall agree on a timeline for conducting all such reviews and approvals that accommodates the Parties’ respective planning and budgeting purposes and allows for necessary or reasonably useful coordination between the Committees. The Combined Major Market Medical Affairs Plan and subsequent revisions thereto will include, with respect to the Major Markets (a) the Parties’ strategy for Medical Affairs Activities ​ ​ [*] = Certain information contained in this document, marked by brackets, has been omitted because it is both not material and is the type of information that we treat as private or confidential. ​ for the Product (including the relative responsibilities of the Parties with respect thereto), (b) an agreed range for the aggregate number of MSLs or MSL FTEs expected to be deployed in the Major Markets either by country or region as reasonably determined by the JMAT, (c) key performance indicators either by country or region, as reasonably determined by the JMAT, that the Parties shall implement, and that shall apply to the activities of the MSLs of each Party in the Major Markets, (d) such information as the JMAT believes necessary for the successful medical affairs support of the Product, such as overall medical strategy, the medical narrative, global advisory boards, publication plans, outcomes/real world evidence strategy, and strategy for investigator- initiated trials and investigator-sponsored research in the Major Markets, and (e) [*] year forecasts and projections for an additional [*] years for such topics included in the Combined Major Market Medical Affairs Plan. The topics included in the Combined Major Market Medical Affairs Plan will be presented both on a global basis across the Major Markets and on a regional basis. In the event of any inconsistency between (i) ...
Sample 1
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Combined Major Market Medical Affairs Plan. The Medical Affairs Activities in support of the Product in the Major Markets shall be described in a plan and budget for Medical Affairs Activities and Medical Affairs Costs (a “Combined Major Market Medical Affairs Plan”). The JMAT shall prepare the first draft of the Combined Major Market Medical Affairs Plan for review and approval by the JSC at least [*] months prior to the first anticipated Launch of the Product in the Major Markets (as such date is reasonably projected by the JDC), and cover a period of [*] years ([*] year forecasted and [*] year projections). Once agreed by the JMAT, the JMAT shall recommend the Combined Major Market Medical Affairs Plan to the JSC for approval. The Combined Major Market Medical Affairs Plan shall be updated at least annually, and all updates and amendments shall be reviewed and approved by the JMAT and then submitted to the JSC for approval. The Parties shall agree on a timeline for conducting all such reviews and approvals that accommodates the Parties’ respective planning and budgeting purposes and allows for necessary or reasonably useful coordination between the Committees. The Combined Major Market Medical Affairs Plan and subsequent revisions thereto will include, with respect to the Major Markets (a) the Parties’ strategy for Medical Affairs Activities for the Product (including the relative responsibilities of the Parties with respect thereto), (b) an agreed range for the aggregate number of MSLs or MSL FTEs expected to be deployed in the
Sample 1

Related to Combined Major Market Medical Affairs Plan

  • 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.

  • Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

  • 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:

  • Development Plan As defined in Section 3.2(a).

  • Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:

  • Clinical Development (a) Stellartech shall design, develop and construct a Clinical Unit for each of the Thermage Disposable Device and the Thermage Generator, and any required component or subassembly thereof and shall deliver such Clinical Units to Thermage in accordance with the Development Program; (b) Stellartech shall deliver to Thermage such other Deliverables as are contemplated by the Development Program in accordance with the Development Program; and (c) as requested by Thermage and automatically at the conclusion of the Development Program, Stellartech, so long as Thermage is not in breach of its material obligation hereunder, shall deliver in writing to Thermage any and all data and information held by or in the control of Stellartech which is necessary or useful to obtain regulatory approval of the Products in the United States or any foreign country.

  • 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.

  • Development Plans 4.3.1 For each Licensed Indication and corresponding Licensed Product in the Field, Licensee will prepare and deliver to Licensor a development plan and budget (each a “Development Plan”). The initial Development Plans for each Licensed Indication will be delivered within […***…] after the Grant Date for such Licensed Indication.

  • Joint Manufacturing Committee A joint manufacturing committee (the “Joint Manufacturing Committee” or “JMC”) will be established pursuant to the Supply Agreement. The roles and responsibilities of the JMC shall be as specified in the Supply Agreement.

  • Development Program A. Development Activities to be Undertaken (Please break activities into subunits with the date of completion of major milestones)

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