Process Development Program definition

Process Development Program means the Bulk Process Development Program and the Product Development Program, collectively.
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Process Development Program means the development by Agilent of various processes for Customer including, without limitation, synthesis, cleavage, de-protection and purification conditions designed to increase scalability and yield of the manufacturing process of certain Molecules, as more specifically described in the Statement of Work.
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Process Development Program means the program for the development of one or more processes, and associated technology, for the manufacture (including scale-up) of Research Antibodies and Candidate Drugs, including processes and technology for the production, purification, evaluation, characterization, stability assessment, vialing and release of a Research Antibody or a Candidate Drug, as applicable, and the performance of other related activities in support of the Registrations for a Candidate Drug or Licensed Product, which are to be conducted pursuant to the Process Science/Clinical Manufacture Agreement.
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Examples of Process Development Program in a sentence

  • Lilly and Ophidian will disclose and make available to each other promptly the results of the work conducted in the Clinical Development Program, Process Development Program and Manufacturing Program, including without limitation all preclinical, clinical, regulatory, and other information known by Lilly or Ophidian concerning the Drug Product at any time during the term of this Agreement.

  • Ophidian shall have principal responsibility for the conduct of the Bulk Process Development Program, and Lilly shall have principal responsibility for the conduct of the Product Process Development Program.

  • The Project Team shall provide the day-to-day management for the collaboration and shall be responsible for directing and overseeing specific activities hereunder, including but not limited to the Clinical Development Program, the Process Development Program and the Manufacturing Program.

  • Lilly will have principal responsibility for the Drug Product Process Development Program, manufacture of Drug Product from Bulk Drug Substance for clinical and commercial supply, the conduct of the Clinical Development Program, and filing and maintenance of regulatory documents necessary for Regulatory Approvals.

  • The Project Team shall prepare and oversee the implementation of a detailed, overall process development plan, which shall address fully the key elements necessary for the Bulk Process Development Program and the Product Process Development Program and for the design and construction of necessary manufacturing facilities and shall further define the roles of each party in the Process Development Program (the "PROCESS DEVELOPMENT PLAN").

  • The Bulk Process Development Program and the Product Process Development Program shall commence as soon as practicable after the Effective Date.

  • As more fully described below, Ophidian will have principal responsibility for the Bulk Drug Substance Process Development Program, the Bulk Manufacturing Program and the manufacture (either itself or through a third party acceptable to Lilly) of Bulk Drug Substance for clinical and commercial supply.

  • Upon the expiration or termination of a Development Program that is performed in whole or in part by ABX for a Candidate Drug, the Development Management Committee shall have no further obligation, responsibility or authority regarding such Candidate Drug, except with respect to the Process Development Program for such Candidate Drug as described below.

  • 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.

  • Except as expressly set forth in Article 16, the right to terminate a Process Development Program or the Process Science/Clinical Manufacture Agreement or the Manufacturing and Supply Agreement and the effects of such termination shall be set forth in the Process Science/Clinical Manufacture Agreement or the Manufacturing and Supply Agreement, as applicable.