Annual Development Plan and Budget Sample Clauses

Annual Development Plan and Budget. As soon as practicable following the Effective Date, and in any event within sixty (60) days following the Effective Date, the JPT shall submit to the SC, and the SC shall review and agree to, the Annual Development Plan for the First Year (or such other period as the SC may decide). For each subsequent Year (or such other period as the SC may decide) prior to or including the anticipated Transition Date and during any other period during which the JPT has responsibilities pursuant to Clause 4.3, the JPT shall prepare a draft Annual Development Plan. For each Year during the Late Development Phase, sanofi pasteur shall prepare a draft Annual Development Plan (unless the JPT has been reconstituted pursuant to Clause 4.1, in which case the JPT shall prepare the draft Annual Development Plan). Each draft Annual Development Plan shall be submitted to the SC for review, modification and if appropriate, as determined by the SC, approval. The JPT or sanofi pasteur, as the case may be, shall manage the preparation and submission of each draft Annual Development Plan (other than the Annual Development Plan for the First Year) in a manner designed to result in approval of such plan, if there is no dispute within the SC, by no later than thirty (30) days prior to the end of the then-current Year or such other date (taking into account the budget cycle of sanofi pasteur) as the SC may decide. Each Annual Development Plan shall describe with reasonable specificity the Development objectives for, and activities to be performed in, the applicable Year (or other period covered by the Annual Development Plan) and an estimated timeline for such activities. During the Early Development Phase and thereafter if and for so long as the Parties agree that any Development Activities shall be conducted by Emergent, each Annual Development Plan shall identify which Development Activities are Emergent Activities and with respect to such Emergent Activities the number of FTEs estimated to be required to perform such activities, the corresponding estimated FTE Cost, and the estimated Emergent Expenses (such estimates for each Year, once approved by the SC, an “Annual Budget”). The Annual Budget for the First Year shall be based on the Indicative Cost Schedule. Each Annual Budget shall be reviewed and if appropriate updated in June of each year or at such other time or times as the SC may agree. No major amendment to an Annual Development Plan shall be effective until approved by the SC...
Sample 1
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Annual Development Plan and Budget. The Development of each Product for a given Year shall be governed by a detailed and specific Territory-wide Development plan covering all material Development activities to be performed for such Product for such Year (including both non‑clinical and clinical activities), and a budget covering all Development Costs for those Development activities for each indication in the Territory (each such plan and budget, as set forth as an Exhibit to this Agreement or when approved by the JEC or, in the event of a [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. dispute on the JEC, in accordance with Section 2.10(c) and, if applicable, Article 13, an “Annual Development Plan and Budget”). Except for the initial Annual Development Plan and Budget attached to this Agreement, each Annual Development Plan and Budget shall be developed by the CFDT (in consultation with the ROCs, if applicable) and submitted for approval by the JDC and JEC. Each Annual Development Plan and Budget for a Product shall cover, and be consistent in all material respects with all of the Development activities set forth in the then-current Long-Term Development Plan for such Product that are to be performed in that particular Year. For the avoidance of doubt, unless otherwise agreed by the Parties or by mutual Party Written Consent or Joint Committee Consent, (i) no additions to, or deletion of, any Development activity set forth in the binding portion of the Long-Term Development Plan for a given Year, (ii) no increase or decrease in the budget for any such Development activity, and (iii) no reallocation of responsibility between the Parties for performance of any such Development activity, in each case ((i), (ii) and (iii)), shall be made in the Annual Development Plan and Budget for such Year. The Annual Development Plan and Budget for the Initial Product for the Year 2007 is set forth on Exhibit I.
Sample 1
Annual Development Plan and Budget 
Sample 1

Related to Annual Development 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.

  • 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.

  • 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).

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Budget Borrower shall submit to Lender for Lender’s written approval (provided that such approval shall only be required in the event that Borrower or any Affiliate of Borrower has the right to approve any such budget pursuant to the terms of the Management Agreement) not to be unreasonably withheld, an annual budget (the “Annual Budget”) within ten (10) Business Days after receipt thereof from Manager, in form satisfactory to Lender setting forth in reasonable detail budgeted monthly operating income and monthly operating capital and other expenses for the Premises. In the event Lender shall have the right to approve such Annual Budget and Lender objects to the proposed Annual Budget submitted by Borrower, Lender shall advise Borrower of such objections within fifteen (15) days after receipt thereof (and deliver to Borrower a reasonably detailed description of such objections) and Borrower shall, within three (3) days after receipt of notice of any such objections, revise such Annual Budget and resubmit the same to Lender. Lender shall advise Borrower of any objections to such revised Annual Budget within ten (10) days after receipt thereof (and deliver to Borrower a reasonably detailed description of such objections) and Borrower shall revise the same in accordance with the process described herein until Lender approves an Annual Budget, provided, however, that if Lender shall not advise Borrower of its objections to any proposed Annual Budget within the applicable time period set forth in this Section, then such proposed Annual Budget shall be deemed approved by Lender. If Lender has the right to approve the Annual Budget pursuant to the terms of the Management Agreement, until such time that Lender approves a proposed Annual Budget, the most recently Approved Annual Budget shall, except as otherwise provided in the Management Agreement, apply; provided that, such Approved Annual Budget shall be adjusted to reflect actual increases in Basic Carrying Costs and utilities expenses. In the event that Owner must incur an Extraordinary Expense, then Borrower shall promptly deliver to Lender a reasonably detailed explanation of such proposed Extraordinary Expense which, if Borrower has the right to approve such expenditures pursuant to the terms of the Management Agreement, shall be subject to Lender’s approval, which approval may be granted or denied in Lender’s reasonable discretion.

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