Development Budgets Sample Clauses
Development Budgets. The first Budget for any Development Period shall be submitted simultaneously with the related Development Plan. Such first Budget shall include the Costs to be incurred during the remaining portion of the Calendar Year in which the relevant Commercial Discovery is declared. The Contractor shall submit the Budget for each subsequent Year no later than September 30 of the immediately preceding Year.
Development Budgets. Promptly after the Effective Date, but in any event within [***] days thereafter, and concurrently with the preparation of the Development Plan pursuant to Section 3.2(a), Celgene shall prepare and submit to the JDC for review the initial Development Budget, which shall be reviewed and approved by the JSC. Celgene shall be solely responsible for the preparation of the budget for the Development activities, including all Clinical Trials, to be conducted solely to support Regulatory Approval of Shared Products for ROW Administration. For Worldwide Development Costs to be incurred from and after the Effective Date, the JSC will review and approve the Development Budget reasonably in advance of the applicable Worldwide Development Costs being incurred (with the intent being to obtain such approval at least [***] months in advance of such costs being incurred, where practicable). Thereafter, the JDC will update and provide the JSC with a copy of the Development Budget, including the budgeted Worldwide Development Costs, each Calendar Year at a meeting of the JSC sufficiently in advance of the next Calendar Year so as to provide the Parties with an opportunity to budget accordingly, but in any event no later than November 1st of each Calendar Year during the Term. The JSC will review and approve any such update or any other amendment to the Development Budget. In addition, either Party may request at any time that the JDC consider, and the JSC approve, other updates to the Development Budget. The Parties understand and agree that, if Vividion does not elect to participate in an Additional Study as set forth in Section 3.4, Celgene shall have the sole right to amend the Development Budget to account for the Direct Costs of such Additional Study (but, for clarity, shall not have the right to impose any additional payment obligations on Vividion for expenses related to such Additional Study, unless and until a Co-Co Buy-In occurs as set forth in Section 3.5, or a Deemed Buy-In occurs pursuant to Section 3.4(c)), after which time any changes to the Development Budget shall be run through the procedures described in this Section 3.2(b). Subject to this Section 3.2(b) and Sections 3.4 and 3.5, all reasonable Direct Costs (including Out-of-Pocket Costs) arising from either Party’s conduct of Development with respect to the Shared Program in accordance with the Development Plan and the Development Budget that qualify as Worldwide Development Costs shall be subject to th...
Development Budgets. The Development budgets for each -------------------
4.6.1 the initial Development budget for the OBD Acute Product shall not exceed ** United States Dollars (US$**). ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
Development Budgets. Each development Budget required under Article 9 of the Agreement shall include:
(i) an estimate on an annual basis in Dollars of the total cost of the development and a sub-division of such total into each main classification and sub-classification of cost. The estimate for each such classification and sub-classification of cost shall be phased on an Accrual Basis and shall be shown by Quarter;
(ii) the items detailed in paragraphs (ii) to (v) inclusive of Section 7.1.1;
(iii) an estimate of the timing and value of the AFEs and commitments to be made under the Budget identifying the total commitments under each main classification of cost in each Quarter of the first Year and the subsequent Year. Operator shall endeavour to provide the timing and estimated commitment for currencies other than Dollars (with the exchange rate used) where such commitment is known;
Development Budgets. During the Initial Development Period, the Development Plan for the Licensed Product will contain a rolling budget covering Development Costs and Development Manufacturing Costs for the FIH Study associated with the anticipated Development activities for the Licensed Product to be performed during [***], and a forecast of the budget of Development Costs and Development Manufacturing Costs for [***] through completion of all Development activities set forth in any such Development Plan (each, a "Development Budget"). The Development Budget will be reviewed and approved by the JDC and JSC (i) [***] at the same time as the Development Plan update or amendment as specified under Section 6.1(b) based on: (A) the Parties' good faith estimation of the anticipated Development activities to be conducted during the relevant [***] period; and (B) information prepared by the Parties in good faith for their own internal planning processes relating to anticipated Development activities for the Licensed Product; or (ii) whenever the estimated total Development Costs within the Development Budget are reasonably expected to increase by at least [***] percent ([***]%) relative to the Development Budget, whether as a result of any amendments to the Development Plan, or increases in costs for the Development activities already planned. Once approved by the JSC, the [***] of such [***] period of each relevant Development Budget shall become JSC approved Development Costs. Following the Initial Development Period, NVS will not have the obligation to provide Pliant or the JSC with a budget for continuing Development Costs or updates thereto.
Development Budgets. A. As part of the Design Development Phase, a proposed landscape construction budget for all items of work under the Scope of Services shall be established and approved.
B. This budget shall be revised and approved at the completion of Design Development Phase and Construction Documentation Phase.
C. In the event that this budget is reduced or increased by more than 10% between the time of approval of the schematic design phase and the time of award of a construction contract, cost of modification of drawings and specifications to meet the changed project budget shall be considered Additional Services.
Development Budgets. Pixar and Disney shall mutually agree on a development budget for the costs and expenses of the creation, development, pre-production and production of each Picture (after Bugs) after approval or selection of the Treatment and prior to the approval of the Picture Budget for such Picture ("Development Budget"). The Development Budget shall be separate from and not include carrying costs or the costs of Computational Resources. Pixar and Disney shall seek to reach mutual agreement on the Development Budget for each Picture. If Pixar and Disney are unable to reach agreement on a Development Budget for a Picture within forty-five (45) days after approval or selection of the Treatment for such Picture, the decision of Pixar as to such Development Budget shall govern, so long as such Development Budget does not exceed [*] dollars (U.S.$[*]) for the second Picture. Such amount shall increase by [*] percent ([*]) or each subsequent Picture.
Development Budgets. Subject to this Section 3.2(b) and Article IX, HEC shall be solely responsible for paying the Development Costs incurred by HEC to conduct the activities set forth in Appendix 2 of the Development Plan (“HEC’s Financial Responsibility”) and Lannett shall pay Thirty-Two Million U.S. Dollars ($32,000,000) for Development Costs (excluding HEC’s Financial Responsibility) pursuant to the following schedule: (a) Five Million U.S. Dollars ($5,000,000) at the earlier of (1) successful completion of manufacturing of a cGMP batch of Insulin Aspart, or (2) July 30, 2021, provided that such payment shall be fully refundable in the event HEC is unable to successfully complete manufacturing of a cGMP batch of Insulin Aspart; and (b) the remaining balance between Thirty-Two Million U.S. Dollars ($32,000,000) minus the amount paid by Lannett for Development activities plus the Five Million U.S. Dollars ($5,000,000) to be paid by Lannett to HEC in two equal payments, with the first payment occurring at the First Commercial Sale of the Product and the second payment occurring twelve (12) months after the first payment (“Lannett’s Financial Responsibility”).. Each Calendar Quarter, Lannett shall provide to HEC a written summary report of the Development activities conducted by Lannett in the previous Calendar Quarter pursuant to the Development Plan 121186093.v1 (including the portion of Lannett’s Financial Responsibility expended in the previous Calendar Quarter) and the Parties shall arrange a mutually convenient time to discuss each such report. Until such time as Lannett has fulfilled Lannett’s Financial Responsibility, an annual budget (to be incurred by both parties) for the Product as provided in this Section 3.2(b) (the “Development Budget”) shall be prepared as follows: (x) before such time as Lannett has fulfilled Lannett’s Financial Responsibility, Lannett shall prepare the Development Budget (provided that, Lannett shall not be entitled to amend HEC’s Financial Responsibility) and (y) after such time Lannett has fulfilled Lannett’s Financial Responsibility, the Parties shall jointly prepare the Development Budget (provided that, neither party shall be entitled to amend Lannett’s Financial Responsibility or HEC’s Financial Responsibility). For Development Costs to be incurred from and after the Effective Date, the Parties will review and approve the Development Budget reasonably in advance of the applicable Development Costs being incurred (with the intent being...
Development Budgets. The Development budget for the Development of the Collaboration Products shall be set forth in the Development Plan. Such Development budget shall be sufficient to fund the agreed studies and related activities necessary to obtain Marketing Approval for such Collaboration Product and generate data otherwise necessary for Commercialization as agreed by the JEC. For the avoidance of doubt, expenses for Non-Global Development Activities will not be included in the Development Plan budget or included as Development Expenses.
Development Budgets. Prior to the POC Milestone Date, (i) all Direct Costs incurred by either Party or its Affiliates in conducting Development activities pursuant to the Development Plan shall be considered Development Costs; (ii) the Parties will update and provide the JSC with a copy of the Development Budget, including the budgeted Development Costs, each Calendar Year at a meeting of the JSC sufficiently in advance of the next Calendar Year but in any event no later than November 1st of each Calendar Year during the Term; and (iii) the JSC will review and approve any such update or any other amendment to the Development Budget. In addition, either Party may request at any time that the JSC consider, and the JSC approve, other updates to the Development Budget.