Initial R&D Plan and Budget Sample Clauses

Initial R&D Plan and Budget. (a) For each Optioned Program, no later than […***…] days after the Initial Option Closing, the JDC shall (i) review and discuss the high-level principles for the worldwide Development of such Optioned Program, (ii) review and discuss the Development activities each Party proposes to conduct or have conducted for such Optioned Program and (iii) prepare and submit to the JSC for review and approval the R&D Plan and Budget for such Optioned Program; […***…]. Such proposed R&D Plan and Budget shall include any Development activities for such Optioned Program proposed by one Party which the other Party agrees to include in the R&D Plan and Budget for such Optioned Program and may include any other Development activities that the Parties mutually agree to include (including Development activities to be Option, License and Collaboration Agreement conducted on a global basis or in both Parties’ Respective Territories). Each Party shall […***…]. Either Party may propose amendments to an R&D Plan and Budget from time-to-time through its members on the JDC. Unless otherwise mutually agreed by the Parties in writing, each R&D Plan shall provide that each Party shall be responsible for the portion of included Development activities occurring in its Respective Territory; provided that, pursuant to Section 4.2(c), Galapagos shall have the right, but not the obligation, to continue to conduct any Clinical Trials that were being conducted by Galapagos in Gilead Territory at the time the applicable Galapagos Program became an Optioned Program, and such Clinical Trials shall be included in the applicable R&D Plan and Budget.
Sample 1
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Initial R&D Plan and Budget. (a) For each Optioned Program, no later than [***] days after the Initial Option Closing, the JDC or its Working Group thereof designated by the JDC shall (i) review and discuss the high-level principles for Development of such Optioned Program, (ii) review and discuss the Development activities each Party proposes to conduct or have conducted for such Optioned Program, (iii) discuss the status and strategy of any Clinical Trial for each Optioned Product in the Optioned Program that was Initiated prior to the Option Exercise Closing, and (iv) prepare and submit to the JSC for review and approval the R&D Plan and Budget for such Optioned Program. Such proposed R&D Plan and Budget shall include any Development activities for such Optioned Program that the Parties agree to include in such R&D Plan and Budget, including activities involving any Optioned Combination that contains an Optioned Molecule that is part of such Optioned Program. Either Party may propose amendments to an R&D Plan and Budget from time-to-time through its members on the JDC.
Sample 1

Related to Initial R&D Plan and Budget

  • Business Plan and Budget To the extent requested by any Initial Lender, as soon as available, but in any event within thirty (30) days after the end of each fiscal year of the Borrower, an annual business plan and budget of the Borrower and its Subsidiaries on a Consolidated basis, including forecasts prepared by management of the Borrower, in form satisfactory to such Lender, of Consolidated balance sheets and statements of income or operations and cash flows of the Borrower and its Subsidiaries on a monthly basis for the immediately following fiscal year. As to any information contained in materials filed with the SEC or furnished pursuant to Section 6.2(f), the Borrower shall not be separately required to furnish such information under Section 6.1(a) or (b) above, but the foregoing shall not be in derogation of the obligation of the Borrower to furnish the information and materials described in Sections 6.1(a) and (b) above at the times specified therein.

  • Annual Business Plan and Budget As soon as practicable and in any event not later than thirty (30) days after the end of each Fiscal Year, a business plan and operating and capital budget of the Borrower and its Subsidiaries for the ensuing four (4) fiscal quarters, such plan to be prepared in accordance with GAAP and to include, on a quarterly basis, the following: a quarterly operating and capital budget, a projected income statement, statement of cash flows and balance sheet, calculations demonstrating projected compliance with the financial covenants set forth in Section 9.15 and a report containing management’s discussion and analysis of such budget with a reasonable disclosure of the key assumptions and drivers with respect to such budget, accompanied by a certificate from a Responsible Officer of the Borrower to the effect that such budget contains good faith estimates (utilizing assumptions believed to be reasonable at the time of delivery of such budget) of the financial condition and operations of the Borrower and its Subsidiaries for such period.

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

  • Development Budget Attached hereto as Exhibit "B" and incorporated herein by this reference is the Development Budget in an amount equal to $_____________. Owner acknowledges and represents that the attached Development Budget includes the total costs and expenses to acquire, develop, renovate and construct the Real Property and the Apartment Housing.

  • Annual Business Plan and Budgets As soon as available but in any event no later than 45 days following the end of each fiscal year of the Borrower, an annual business plan and budget of the Consolidated Parties containing, among other things, pro forma financial statements for the next four fiscal quarters and the next fiscal year.

  • 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.

  • Research Plan The Parties recognize that the Research Plan describes the collaborative research and development activities they will undertake and that interim research goals set forth in the Research Plan are good faith guidelines. Should events occur that require modification of these goals, then by mutual agreement the Parties can modify them through an amendment, according to Paragraph 13.6.

  • 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 Schedule The schedule for design and development of the "BASE BUILDING WORK" (as defined below) and the "TENANT IMPROVEMENTS" (as defined below), including, without limitation, the time periods for preparation, delivery, review, and approval of construction documents and performance pursuant to such documents, shall be in accordance with the Development Schedule attached hereto as Schedule A, subject to adjustment as mutually agreed by the parties in writing or as provided in this Work Letter (the "DEVELOPMENT SCHEDULE").

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