Development Plan Budget Sample Clauses

Development Plan Budget. Acceleron shall prepare the first draft of the initial Development Plan/Budget and present it to Celgene at least 15 days prior to the first meeting of the Joint Development Committee. With respect to the initial Development Plan/Budget, the Joint Development Committee shall, within sixty (60) days after the Effective Date, approve and submit to the Parties the initial Development Plan/Budget. Thereafter, the Joint Development Committee shall prepare a draft of the Development Plan/Budget at least one hundred twenty (120) days prior to the commencement of any Contract Year. During the Agreement Term, the Joint Development Committee shall, at least ninety (90) days prior to the commencement of any Contract Year during the Agreement Term, approve and submit to the Parties the Development Plan/Budget. Each Development Plan/Budget shall contain the specific Development and Manufacturing objectives to be achieved by Celgene during the Contract Year, the specific Development and Manufacturing objectives to be achieved by Acceleron during the Contract Year, and the timeline for performing such Development objectives.
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Development Plan Budget. The Initial Development Plan is accompanied by a budget, broken down in annual sub-budgets, setting forth the projected total, and annual, Development Expenses under the Initial Development Plan (the “Initial Development Plan Budget”). [* * *] of each Calendar Year, the Development Plan Budget then in effect shall be reviewed by the JPT and any proposed modifications, if necessary, shall be submitted to the JSC for review and approval. Upon approval by the JSC, the modified Development Plan Budget shall forthwith govern. Any conflict between the Parties in the JSC regarding any updated Development Plan Budget shall be resolved in accordance with Article 3.4. Development Expenses identified within the Development Plan Budget shall initially be borne by the Party incurring the cost or expense, subject to reconciliation and reimbursement pursuant to Article 4.10.
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Development Plan Budget. Responsibility for any Development Plan budget shall rest with the DT, which shall develop budgets for Development, subject to final approval by the JSC. Budgets will be prepared annually as set forth in Section 3.1.2. Any dispute relating to the amount of a Development Plan budget shall be considered a Reserved Dispute subject to resolution pursuant to Section 12.2. Such budgets shall include Development FTE Rates for FTEs conducting Product Development activities. The financial representatives from Cephalon and Alkermes appointed pursuant to Section 3.2 will be responsible for identifying, analyzing and reporting to the DT all significant [**] between the budget and the actual costs incurred and all [**] between the budget and such costs. If any costs for a Development activity result in an increase [**] in the approved budget of more than [**]percent ([**]%) for a given calendar quarter, the DT shall forward to the JSC the report it received from the ** CONFIDENTIAL TREATMENT REQUESTED financial representatives, and the JSC shall review such costs and shall designate them as Development Costs if the JSC determines that incurring such costs was [**]. [**]. A [**]-year long-range plan for Development of the Products in the Field in the Territory (including the budget for Development Costs) shall be established on a yearly basis under the direction of the DT as set forth in Section 3.1.2 and shall be submitted to the JSC for final approval.
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Development Plan Budget. Each Development Plan shall include a budget (the “Development Plan Budget”) specifically including, but not limited to Development Costs. With respect to any Development Plan Budget under which the Parties are sharing Development Costs pursuant to Sections 3.4.5 or 3.4.8, the Development Plan Budget shall be agreed upon by the Steering Committee. Each Development Plan Budget shall, on an accrual basis, include an estimate of the Development Costs expected to be incurred to complete activities by each of Osiris, Genzyme and any Third Party, respectively, during the period covered by such Development Plan.
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Development Plan Budget. Licensee shall be responsible, in consultation with Company through the JDC, for preparing a detailed budget of the estimated Development Costs for conducting the Development activities for a Product set forth in the applicable Development Plan, including FTE costs and Out-of-Pocket Costs, for each applicable Calendar Year (as amended from time to time, the “Development Plan Budget”). Licensee shall submit the initial Development Plan Budget and any amendments thereto to the JDC for review and approval in accordance with Article VI. The initial Development Plan Budget with respect to the Development of the first Vabomere Product in Asia-Pacific will be discussed during the first JDC following the Effective Date. Subject to Section 5.2(a), Licensee will discuss with Company the initial Development Plan Budget for the Development of the Minocin IV Product in the EU together with delivery of the initial Development Plan for the Development of the Minocin IV Product in the EU.
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Development Plan Budget. 24 3.8 Limitation on Development Team Decision Making.................. 25 ARTICLE 4 COMMERCIALIZATION................................................ 25
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Development Plan Budget. (a) Each Celgene Development Plan/Budget shall contain the specific Development and Manufacturing objectives in the Celgene Field to be achieved by Celgene during the applicable Contract Year, the specific Development and Manufacturing objectives in the Celgene Field to be achieved by Acceleron during the applicable Contract Year, and the timeline for performing such Development objectives.
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Development Plan Budget 
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Related to Development Plan Budget

  • 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 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.

  • 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.

  • 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.

  • Project Plan Development of Project Plan Upon the Authorized User’s request, the Contractor must develop a Project Plan. This Project Plan may include Implementation personnel, installation timeframes, escalation procedures and an acceptance plan as appropriate for the Services requested. Specific requirements of the plan will be defined in the RFQ. In response to the RFQ, the Contractor must agree to furnish all labor and supervision necessary to successfully perform Services procured from this Lot. Project Plan Document The Contractor will provide to the Authorized User, a Project Plan that may contain the following items: • Name of the Project Manager, Contact Phone Numbers and E-Mail Address; • Names of the Project Team Members, Contact Phone Numbers and E-Mail Address; • A list of Implementation milestones based on the Authorized User’s desired installation date; • A list of responsibilities of the Authorized User during system Implementation; • A list of designated Contractor Authorized Personnel; • Escalation procedures including management personnel contact numbers; • Full and complete documentation of all Implementation work; • Samples of knowledge transfer documentation; and • When applicable, a list of all materials and supplies required to complete the Implementation described in the RFQ. Materials and Supplies Required to Complete Implementation In the event that there are items required to complete an Implementation, the Contractor may request the items be added to its Contract if the items meet the scope of the Contract. Negotiation of Final Project Plan If the Authorized User chooses to require a full Project Plan, the State further reserves the right for Authorized Users to negotiate the final Project Plan with the apparent RFQ awardee. Such negotiation must not substantively change the scope of the RFQ plan, but can alter timeframes or other incidental factors of the final Project Plan. The Authorized User will provide the Contractor a minimum of five (5) business days’ notice of the final negotiation date. The Authorized User reserves the right to move to the next responsible and responsive bidder if Contractor negotiations are unsuccessful.

  • 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 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 Project shall substantially comply with the specific timetables and triggers for action set forth in Article 5 of this Agreement. The parties acknowledge that, as provided in G.S. 160A-400.25(b), the failure to meet a commencement or completion date shall not, in and of itself, constitute a material breach of this Agreement pursuant to G.S. 160A-400.27 but must be judged based upon the totality of the circumstances.

  • 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.

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