General; ROW Development Plan Sample Clauses

General; ROW Development Plan. Takeda shall conduct the Development of the Product for the ROW Territory, in collaboration and consultation with Cell Genesys through the JDC subject to the terms and conditions of this Agreement, and pursuant to a written development plan (the “ROW Development Plan”). The ROW Development Plan will be summary in nature, but will include all Development and Manufacturing activities anticipated to be required for obtaining Regulatory Approval in the ROW Territory and timelines regarding such activities. The ROW Development Plan shall also specify the plans and timeline for preparing the necessary Regulatory Materials and for obtaining Regulatory Approval in the ROW Territory for the first indication and any label expansion. On at least an annual basis (no later than December 1 of each calendar year, commencing in 2008), Takeda shall update and amend, as appropriate, the then-current ROW Development Plan and shall submit such updates and/or amendments for review and comment by the JDC. Takeda shall review and consider all comments to the ROW Development Plan from the JDC or JSC in good faith. The ROW Development Plan shall not require the approval of the JDC or the JSC, but this shall not excuse Takeda from otherwise meeting its obligations with respect to the Development of the Product in the ROW Territory as provided in this Agreement. Except for the VITAL Studies conducted by Cell Genesys or as Cell Genesys may agree at the JSC, Takeda will be responsible, at its expense for conducting all studies necessary or desirable for any Regulatory Approvals in the ROW Territory pursuant to the ROW Development Plan.
AutoNDA by SimpleDocs

Related to General; ROW Development Plan

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

  • Program Development NWESD agrees that priority in the development of new applications services by XXXXX shall be in accordance with the expressed direction of the XXXXX Board of Directors operating under their bylaws.

  • Curriculum Development This includes the analysis and coordination of textual materials; constant review of current literature in the field, some of which are selected for the college library collection, the preparation of selective, descriptive materials such as outlines and syllabi; conferring with other faculty and administration on curricular problems; and, the attendance and participation in inter and intra-college conferences and advisory committees.

  • Professional Development Plan Professional Development Plan (PDP) refers to plans developed by faculty members addressing the criteria contained in Article 22 and Appendix G.

  • 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.

  • 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.

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

  • Staff Development ‌ The County and the Association agree that the County retains full authority to determine training needs, resources that can be made available, and the method of payment for training authorized by the County. Nothing in this subsection shall preclude the right of an employee to request specific training.

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

  • Joint Development If joint development is involved, the Recipient agrees to follow the latest edition of FTA Circular 7050.1, “Federal Transit Administration Guidance on Joint Development.”

Time is Money Join Law Insider Premium to draft better contracts faster.