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 3.1(a), the Parties shall cooperate to prepare the initial Development Budget, which shall be reviewed and approved by the JSC. The Lead US Party shall be responsible for the preparation of the applicable portion of the budget for the Development activities, including all Clinical Trials, to be conducted solely to support Regulatory Approval of Shared Products in the US Territory, and Celgene shall be responsible for the preparation of the portion of the budget for the Development activities, including all Clinical Trials, to be conducted solely to support Regulatory Approval of Shared Products in the ROW Territory. All reasonable Direct Costs incurred by either Party or its Affiliates in conducting (i) Development activities pursuant to the Development Plan, or (ii) Additional Studies that the Parties agree to conduct pursuant to Section 3.3 following the Agreement Effective Date shall be considered Development Costs or Manufacturing Costs or other Allowable Expenses, as applicable, and shall be included in Allowable Expenses for the purposes of calculating the Profit & Loss Share. For Development Costs and related Manufacturing Costs and other Allowable Expenses to be incurred from and after the Effective Date, the JSC will review and approve the Development Budget reasonably in advance of the applicable Development Costs or Manufacturing Costs or other Allowable Expenses being incurred (with the intent being to obtain such approval at least [***] months in advance of such costs being incurred, where practicable). Thereafter, the JSC will update and provide the JDC with a copy of the Development Budget, including the budgeted Development Costs and related Manufacturing Costs and other Allowable Expenses, each Calendar Year at a meeting of the JDC 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 the Non-Proposing Party does not elect to participate in an Additional Study ...
Development Budgets. The Development budgets for each -------------------
Development Budgets. Each development Budget required under Article 9 of the Agreement shall include:
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 Xxxxxxx shall pay up to Thirty-Two Million U.S. Dollars ($32,000,000) for Development Costs (excluding HEC’s Financial Responsibility) pursuant to the Development Plan, including those Out-of-Pocket Costs spent by Xxxxxxx beginning on April 1, 2018 set forth on Schedule 3.2(b) (“Xxxxxxx’s Financial Responsibility”). Each Calendar Quarter, Xxxxxxx shall provide to HEC a written summary report of the Development activities conducted by Xxxxxxx in the previous Calendar Quarter pursuant to the Development Plan (including the portion of Xxxxxxx’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 Xxxxxxx has fulfilled Xxxxxxx’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 Xxxxxxx has fulfilled Xxxxxxx’s Financial Responsibility, Xxxxxxx shall prepare the Development Budget (provided that, Xxxxxxx shall not be entitled to amend HEC’s Financial Responsibility) and (y) after such time Xxxxxxx has fulfilled Xxxxxxx’s Financial Responsibility, the Parties shall jointly prepare the Development Budget (provided that, neither party shall be entitled to amend Xxxxxxx’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 to obtain such approval at least six (6) months in advance of such costs being incurred, where practicable). Thereafter, Xxxxxxx will update and provide HEC with a copy of the Development Budget, including the budgeted Shared Development Costs, each Calendar Year sufficiently in advance of the next Calendar Year so as to provide the Parties with an opportunity approve the Development Budget and to budget accordingly, but in any event no later than November 1st of each Calendar Year during the Term. HEC may request at any time that Xxxxxxx consider other updates to the Development Budget. Both parties will r...
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.
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. 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. 1. In addition to all the foregoing, there will exist an experimental process development budget, whose planning and execution will be a coordinated by the Technical Management.
Development Budgets. 10 c. Picture Budgets 10 d.
