Development Plans and Budgets Sample Clauses

Development Plans and Budgets. Promptly after the selection by the JRC of a SAC for development as a Collaboration Product by the Parties, the JDC shall prepare and provide to each Party for final approval a development plan for such SAC (the "Development Plan"). The Development Plan shall include all needed details regarding the Preclinical and Clinical Development, and other work to be undertaken to develop and produce the International Registration Dossier for such Collaboration Product, including an allocation of all such work as appropriate to each Party (or to selected Third Party contractors, as agreed), and shall establish a budget (the "Development Budget") for all costs and expenses to be incurred by each Party in conducting the work allocated to it under such Development Plan. The budget will be based on (i) an allocation of Full Time Equivalent (FTE) personnel of each Party working under the Development Plan, with each FTE costed at an annualized rate of U.S.$[...***...] (which rate will be increased on each anniversary of the Effective Date by [...***...]%); (ii) the actual extraordinary direct costs approved by the JDC, and (iii) the actual costs of work performed by Third Parties as approved by the JDC. Each Party shall diligently review the proposed Development Plan and shall either approve the plan or provide the JDC any requested changes and comments. If a Party provides such requested changes or comment to a proposed Development Plan, the JDC shall review the proposed changes within thirty (30) days, and as appropriate, thereafter prepare a revised draft of the Development Plan, accommodating such changes and comments, and resubmit such revised Development Plan for approval by the Parties as provided above. Once the Parties have agreed on the Development Plan proposed by the JDC, such Development Plan shall be effective and shall control and govern the Parties' development effort with respect to the applicable Product, subject to any subsequent amendments or modifications to such Development Plan as provided below. From time to time during the development of such Collaboration Product, the JDC shall review the Development Plan in light of the results of the development work and any other relevant Information and shall amend or modify the Development Plan as appropriate, provided that the JDC may not increase the applicable Development Budget without the written approval of each Party. At least sixty (60) days prior to January 1 of any year in which the Parties are dev...
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Development Plans and Budgets. (a) Prepare annually for Owner’s review, revise, and submit for Owner’s approval Development Plans and Budgets (and amendments and modifications to previously approved Development Plans and Budgets), and consulting with Owner as to such proposed development plans and budgets (or amendments and modifications thereto), including any amendments or modifications reasonably necessary following Owner’s acquisition of additional Oil and Gas Interests.
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Development Plans and Budgets. Each Plan and Budget for Development is expected to include a reasonably detailed description of (and Budget for) all Development activities, such as for: (i) IND enabling studies; (ii) Clinical Trials; (iii) Manufacture and preparation of clinical supplies and placebo, including developing, establishing, and scaling-up Manufacturing capabilities for Commercialization; (iv) preparation and submission of XXXx; and (v) any post-approval Clinical Trials (including phase IV Clinical Trials). The Parties will mutually agree on a consistent methodology for allocation of general and administrative expenses (as defined under GAAP) that are attributable to the activities contemplated in each Plan.
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Development Plans and Budgets. For each Licensed Product in Development, the Development Team shall, on an annual basis, prepare a development plan and budget (the "DEVELOPMENT PLAN AND BUDGET"). Each Development Plan and Budget shall describe the overall program of Development for the Licensed Product in question, and a budget for related Development activities in the forthcoming calendar year. For Local/Regional ONYX-015, an initial Development Plan and Budget covering the period from September 1, 1999 through December 31, 1999 has been separately agreed to by the Parties.
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Development Plans and Budgets. During the term of the Development Program, TWT shall prepare in consultation with BML and provide to the Development Committee a reasonably detailed Development Plan and Budget pursuant to which performance of the Development Program will be performed. The Development Plan and Budget shall specify, on a Target-by-Target basis, the objectives, activities, timing and cost of the Development Program, together with a headcount of full time equivalents (FTEs) of TWT personnel to be devoted to the Development Program. The Development Plan shall also set forth the estimated Transfer Price of the Collaboration Product being developed. The Development Plan and Budget for a particular year shall include funding equal to the greater of: (i) the advance payments provided for such year in Section 7.2.1 below or (ii) such greater amount as established by the Development Committee including reimbursement for external expenses not included in the FTE rate (if any) incurred in accordance with the Development Plan and Budget in effect from time to time.
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Development Plans and Budgets. Within [c.i.] of the Execution Date, and by [c.i.] of each year thereafter during the Term of the Development Program, DUSA shall submit to the Development Committee a good faith proposed plan and budget for the activities to be undertaken as part of the Development Program in the next succeeding calendar year. After reviewing and considering such proposal, the Development Committee shall prepare a reasonably detailed Development Plan and Budget pursuant to which the Development Program will be carried out. For the purpose of facilitating the long-term planning of goals for the development of the Collaboration Products, the Development Committee shall also develop a reasonably detailed [c.i.] development plan for each Collaboration Product included in the Development Program (the "[c.i.] Plan").
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Development Plans and Budgets. (i) In the event that there is a tie vote of the Managers (a “Deadlock”) prior to the earlier of the end of the Catch-Up Period and December 31, 2011 (the “Initial Deadlock Period”) regarding approval of a Development Plan and Budget that is applicable to the Initial Deadlock Period and that is not resolved through negotiation by the Managers after a period of 60 days, Investor shall be entitled to suspend the Company’s exploration and drilling activities and all other cash expenditures of the Company, other than the minimum expenses required for salaries and benefits of critical employees of the Company and to maintain the existing operations of the Company (but not exploration, drilling, workover or similar activities) (a “Suspension”), provided that there has not been an Investor Default that remains uncured. In the event that there is a Deadlock following the Initial Deadlock Period regarding approval of a Development Plan and Budget that is not resolved through negotiation by the Managers after a period of 60 days, either Member shall be entitled to effectuate a Suspension, provided that, in the case of a Suspension sought by Investor, there has not been an Investor Default or other default on an obligation to make a Capital Contribution that remains uncured, and in the case of a Suspension sought by PDC, it has not defaulted on an obligation to make a Capital Contribution that remains uncured. During the pendency of a Deadlock with respect to a Development Plan and Budget, the most recently-approved Development Plan and Budget shall apply for purposes of prudently maintaining existing operations (but excluding suspended activities); provided, however, that, unless the Board of Managers otherwise determines, in no event shall the Company incur any expenses or pay funds in excess of the Company’s cash flow during a Suspension.
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Development Plans and Budgets 
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Related to Development Plans and Budgets

  • 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 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.

  • Business Plan and Budget As soon as available, but in any event no later than forty five (45) 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 reasonably satisfactory to the Lender, of Consolidated balance sheets and statements of income or operations and cash flows of the Borrower and its Subsidiaries on a quarterly basis for the then current fiscal year. As to any information contained in materials furnished pursuant to Section 6.02(d), the Borrower shall not be separately required to furnish such information under Sections 6.01(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 6.01(a) and (b) above at the times specified therein.

  • 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.

  • 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.

  • 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:

  • 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.

  • Research Plans The Research Plan for the [***] Designated Target is attached as Schedule 2.2.3-1. Subsequent Research Plans agreed upon in accordance with Section 2.4.2.4 will be attached as additional sequentially numbered schedules (Schedule 2.2.3-2, Schedule 2.2.3-3, etc.).

  • Development Work The Support Standards do not include development work either (i) on software not licensed from CentralSquare or (ii) development work for enhancements or features that are outside the documented functionality of the Solutions, except such work as may be specifically purchased and outlined in Exhibit 1. CentralSquare retains all Intellectual Property Rights in development work performed and Customer may request consulting and development work from CentralSquare as a separate billable service.

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