Global Development Budget Sample Clauses
Global Development Budget. Confidential Treatment Requested
(a) The Global Development Budget shall be included, among other things, in the Global Development Plan. The Global Development Budget shall include reasonable estimates of total Global Development Costs and allocation of Internal FTEs on a year-by-year basis and specify in reasonable detail on a study-by-study and activity-by-activity basis the Global Development Costs expected to be incurred for the current and next succeeding calendar years.
(b) The Global Development Budget shall be approved by the Joint Development Committee in accordance with the provisions of Sections 2.2.4 and 2.3 hereof, and further approved by the Joint Steering Committee in accordance with Section 5.6.4 and during the last quarterly meeting of each calendar year, the Joint Development Committee shall review and propose modifications for the Joint Steering Committee to approve in accordance with Section 5.6.4, as necessary or advisable, the Global Development Budget, and shall in connection therewith specify in reasonable detail on a study-by-study and activity-by-activity basis the Global Development Costs expected to be incurred for the next succeeding calendar year. Subject to the provisions of Sections 2.2.4 and 2.3 hereof, any such amendment shall be by written agreement signed by a representative from each Party and the Global Development Budget as so amended and agreed by the Parties will thereupon become effective.
(c) The Joint Development Committee shall review on a quarterly basis any variance between actual Global Development Costs and budgeted Global Development Costs for the immediately preceding quarter, shall determine the reasons for any such variances, assess whether such variances are likely to continue, and, if necessary or advisable, agree on a revised Global Development Budget or otherwise request that one or both Parties take such actions as are required to address or remedy the continuation of such variance.
Global Development Budget. The initial Global Development Budget is attached hereto in Schedule 4.4.1 (Initial Global Development Plan and Initial Global Development Budget). Subsequent Global Development Budgets will consist of a detailed written budget, broken down on a [**] basis, for the performance of those activities allocated to each Party under the Global Development Plan for the [**], which budget will include the Development FTE Costs to be incurred by each Party in performing each of the Global Development Activities under the Global Development Plan, as well as any direct Out-of-Pocket Costs expected to be incurred in connection with the performance of the Global Development Activities under the Global Development Plan and all Manufacturing Costs associated with the Manufacture of the Products for purposes of performing the applicable Global Development Activities.
Global Development Budget. The Global Development Plan will contain the Global Development Budget. The first full Calendar Year of the then-current Global Development Budget, will be binding for purposes of calculating First Tier GDP Overruns and Second Tier GDP Overruns as provided in Section 3.8.5, and will be non-binding for all other purposes. The Global Development Budget, and each update thereto, will be prepared by Licensee based on Licensee’s good faith estimation, consistent with its standard internal practices, of the probable Development activities to be conducted during the relevant Global Development Budget period, and based on and consistent with the documents and information related to the Licensed Products prepared by Licensee for its internal use and reference in the budgeting process. Upon request by Relay, the JDT will discuss the appropriate level of detail to include in the Global Development Budget for the applicable Development activities to be performed during the period covered by such Global Development Budget.