Comprehensive Development Plans and Budgets Sample Clauses

Comprehensive Development Plans and Budgets. 3.2.2 Annual Development Plans and Budgets
Sample 1
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Comprehensive Development Plans and Budgets. The Development of a Product for each Indication shall be governed by a comprehensive, multi-year, worldwide plan covering the Development of such Product for each such Indication for use in the United States, Canada, each of the Major European Countries and Europe as a whole, Japan and, broken out on a Region-by-Region or country-by-country basis only to the extent BMS does so for its own internal oncology products, the remaining countries in the Territory, and a budget relating to such Development for the United States for each such Indication, including all Clinical Trials, wherever conducted. Each such plan and budget for an Indication for a Product (a “Global Development Plan and Budget”) shall: (a) provide a planned Development program and budget that is designed to generate the non-clinical, clinical and regulatory information required for filing Drug Approval Applications and to achieve Approvals and Compendia Listings, as applicable, for such Indication in the United States; (b) provide a planned Development program that, consistent with Section 3.6, is designed to generate the non-clinical, clinical and regulatory information required for filing Drug Approval Applications and to achieve Approvals for such Indication in the Royalty Territory, (c) indicate, for each Clinical Trial and other Development activity identified therein, whether such Clinical Trial and activities will be relied on in support of Initial Regulatory Approval (or, with respect to the United States, a Compendia Listing, as applicable) for such Indication in the United States, the EU or Japan, and, if such Clinical Trial or activity is in support of Initial Regulatory Approval (or a Compendia Listing, as applicable) for an Indication in the United States, a budget for the Clinical Costs and other Development Costs of such Clinical Trials and other activities; (d) set forth the Success Criteria and Decision Points for the Development of such Indication; and (e) set forth those obligations assigned to each Party with respect to the performance and funding of the Development activities contemplated by such Global Development Plan and Budget.
Sample 1

Related to Comprehensive Development Plans and Budgets

  • Annual Work Plans and Budgets The Recipient shall furnish to the Association as soon as available, but in any case not later than September 1 of each year, the annual work plan and budget for the Project for each subsequent year of Project implementation, of such scope and detail as the Association shall have reasonably requested, except for the annual work plan and budget for the Project for the first year of Project implementation, which shall be furnished no later than one (1) month after the Effective Date.

  • 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.

  • 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.

  • Improvement Plans A. A professional improvement plan is a clearly articulated assistance program for a teacher whose student growth measure dimension of the evaluation is below the expected level of student growth. For the purposes of this agreement, improvement plans shall be based on the individual student growth measure level, and not for overall subjects or classes taught.

  • 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.

  • Improvement Plan A written plan developed by the evaluator, utilized when a teacher received a Rating of Ineffective on his/her Evaluation or on any individual deficiency in the evaluation system.

  • 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 Work Do, or cause to be done, such development and other work as may be reasonably necessary to protect from diminution and production capacity of the Mortgaged Property and each producing well thereon.

  • Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in xxxxx, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

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