Process Development and Manufacturing Plans Clause Samples
The 'Process Development and Manufacturing Plans' clause outlines the requirements and procedures for creating, reviewing, and updating plans related to the development and manufacturing of a product. Typically, this clause specifies the responsibilities of each party in drafting detailed plans, timelines, and milestones for process development, as well as the approval process for any changes. Its core function is to ensure that both parties are aligned on the steps and expectations for manufacturing, thereby minimizing misunderstandings and facilitating efficient project management.
Process Development and Manufacturing Plans. The Parties, through the JMC, will develop and update as necessary, for each Licensed Product, a Manufacturing Plan. The JMC shall be responsible for deciding on process and technology selection, on process improvements and all related process development activities which impact manufacturing. The JMC shall also be responsible for all decisions relating to Manufacturing Formulated Bulk Product for Clinical Supply Requirements of Licensed Products. Each Manufacturing Plan shall set forth the supply requirements of a Licensed Product over an ensuing period of at ***************. The Manufacturing Plan will include arrangements for the Manufacture of back-up Formulated Bulk Product for Licensed Product requirements at a Party or a Third Party back-up Manufacturing facility. The Manufacturing Plan (including each annual update thereto) shall be prepared by the JMC and approved by the JSC at least two (2) months prior to the end of the then current Contract Year, except that the initial Manufacturing Plan covering at least initial expected Clinical Supply Requirements for a Licensed Product, to the extent not included in the Initial Development Plan, shall be approved by the JSC within the initial Global Development Plan. The Parties shall design Manufacturing Plans to ensure an adequate supply of Licensed Product and shall use Commercially Reasonable Efforts to perform their responsibilities in accordance with the approved Manufacturing Plans.
Process Development and Manufacturing Plans. Upon the request of the Development Management Committee or AZ, ABX, in consultation with AZ, shall prepare an overall written plan for the process development of one or more Research Antibodies and Candidate Drugs that bind to and are directed against the applicable Collaboration Antigen and the manufacture and supply of clinical and commercial quantities of the resulting Licensed Products, which plan has as its goals (based upon the reasonable projections and other assumptions provided by the Development Management Committee) the earliest possible launch of such Licensed Products in each of the Major Markets and a secure supply chain to be able to meet the market demand for such Licensed Products in the Major Markets through at least the fifth (5th) anniversary of the First Commercial Sale of such Licensed Products (the “Process Development and Manufacturing Plan”). In addition to the overall plan, the initial Process Development and Manufacturing Plan for a Collaboration Antigen will include a more detailed plan for the Process Development Program for one or more lead Research Antibodies and the resulting Candidate Drug(s) that details the activities set forth in Section 7.2.3 and such other activities as are necessary to complete such Process Development Program, including specific details of FTEs to be utilized by ABX, technologies to be employed by ABX in accordance with Section 7.13 and any Third Party contractors proposed to be used to implement such Process Development and Manufacturing Plan. As soon as practicable after the designation of a Candidate Drug, the Parties will amend the Process Development and Manufacturing Plan to include additional detail around the clinical and commercial manufacture and supply of such Candidate Drug and any resulting Licensed Product. The Parties acknowledge and agree that each Process Development Program may be an iterative process and, therefore, each Process Development and Manufacturing Plan will be amended from time to time to include specific detail regarding activities to be performed and the learning developed in the course of such Process Development Program as well as the specific manufacturing and supply requirements for the resulting Licensed Products.