Common use of Development Plan and Budget Clause in Contracts

Development Plan and Budget. The initial Development Plan and initial Budget agreed to by the Parties will be developed by the Parties with final review and approval by the Alliance Steering Committee. The Development Plan and Budget will be updated by the Alliance Steering Committee on at least a quarterly basis. Prior to the start of each calendar year, the Alliance Steering Committee shall meet to review and approve a Development Plan and Budget for the following calendar year. No material deviations (e.g., major changes in clinical study design, patient populations, clinical trial endpoints, or the analysis of such endpoints) from the Development Plan or Budget will occur without prior approval by the Alliance Steering Committee. The Development Plan will include the following elements: (a) a clinical trial program for the Product(s) in the Territory, (b) a Product Registration Plan, (c) a Publication Plan, and (d) a Distribution, Selling and Marketing Plan for the Product(s). No company sponsored clinical trial shall be commenced for the Product(s) in the Territory without the approval of the Alliance Steering Committee. The Budget detail will contain specific estimates of allocation of administrative and finance costs, country or region-specific allocation of "sales force time and effort" (as defined in Section 5.6), and country specific-profit and loss estimates.

Development Plan and Budget. The initial Development Plan and initial Budget agreed to by the Parties will be developed by the Parties with final review and approval by the Alliance Steering Committee. The Development Plan and Budget will be updated by the Alliance Steering Committee on at least a quarterly basis. Prior to the start of each calendar year, the Alliance Steering Committee shall meet to review and approve a Development Plan and Budget for the following calendar year. No material deviations (e.g., major changes in clinical study design, patient populations, clinical trial endpoints, or the analysis of such endpoints) from the Development Plan or Budget will occur without prior approval by the Alliance Steering Committee. The Development Plan will include the following elements: (a) a clinical trial program for the Product(s) in the Territory, (b) a Product Registration Plan, (c) a Publication Plan, and (d) a Distribution, Selling and Marketing Plan for the Product(s). No company sponsored clinical trial shall be commenced for the Product(s) in the Territory without the approval of the Alliance Steering Committee. The Budget detail will contain specific estimates of allocation of administrative and finance costs, country or region-specific allocation of "sales force time and effort" (as defined in Section 5.6), and country specific-profit and loss estimates.or