Development Plan Budget Clause Samples
The Development Plan/Budget clause outlines the requirements for creating, approving, and adhering to a detailed plan and budget for a project’s development phase. Typically, this clause specifies the process for preparing the plan and budget, the parties responsible for approval, and the procedures for making amendments if necessary. For example, it may require both parties to agree on milestones, deliverables, and associated costs before work begins. The core function of this clause is to ensure transparency and mutual agreement on the scope, timeline, and financial commitments of the development process, thereby minimizing misunderstandings and disputes over project expectations and expenditures.
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.
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.
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.
Development Plan Budget. 24 3.8 Limitation on Development Team Decision Making.................. 25 ARTICLE 4 COMMERCIALIZATION................................................ 25
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.
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.
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.
(b) Each PH Field Development Plan/Budget shall contain the specific Development and Manufacturing objectives in the PH Field to be achieved by each Party during the applicable Contract Year, and the timeline for performing such Development objectives.
(c) Acceleron shall prepare the first draft of the initial PH Field Development Plan/Budget and present it to Celgene at the first Joint Development Committee meeting in Contract Year 2018, and the Parties agree that (a) Acceleron may conduct all PH Field Development Activities that are Acceleron Development Activities prior to such meeting and (b) Celgene will conduct all PH Field Development Activities that have been designated in writing previously as Celgene Development Activities prior to such meeting.
(d) With the exception of the PH Field Development Plan/Budget for Contract Year 2018, the Joint Development Committee shall prepare a draft of a revised Development Plan/Budget for each 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 each revised Development Plan/Budget. At any time during the Agreement Term, the Joint Development Committee may approve amendments to a Development Plan/Budget.
Development Plan Budget