Product Specific Agreement definition

Product Specific Agreement or “PSA” is defined in Section 2.1.
Sample 1Sample 2Sample 3
Product Specific Agreement or “PSA” means a separate written agreement specific to each Product and/or Service (Formulated Drug Substance, Drug Product, Cell Line development, etc.), entered into and mutually agreed to from time to time by duly authorized representatives of the Parties. Each PSA shall refer to and be integrated in this MSA and may include, without limitation, details such as (i) a clearly defined scope of work of the Services to be performed under such PSA which describes key activities and assumptions, (ii) the Product for which SBL will perform such Services for Client, (iii) the fees to be paid to SBL by Client for the Services, and (iv) any other deliverables.
Sample 1
Product Specific Agreement or “PSA” means a separate agreement specific to each Product (e.g., Cell Line Development, Process Development, Manufacture of Drug Substance or Drug Product, etc., for such Product), entered into and mutually agreed from time to time by duly authorized representatives of the Parties. Each PSA shall refer to and be integrated in this MDSA and may include, without limitation, details such as (i) a high level scope of work of the Services to be performed under such PSA which describes key activities and assumptions, (ii) the Product for which SBL will perform such Services for Client, (iii) fees to be paid to SBL by Client for the Services, and (iv) any other deliverables. Any Scope of Work, Project Plan, or Decision Memo attached to or executed under a PSA will be considered part of such PSA and will be deemed to be included in references herein to such PSA.
Sample 1

Examples of Product Specific Agreement in a sentence

  • Prior to the expiration of this PSA, the Parties shall use Commercially Reasonable Efforts to negotiate in good faith and enter into a new Product Specific Agreement that would govern SBL’s provision of Manufacturing Services as required by Client for the Commercial Product for Years after 2031.


More Definitions of Product Specific Agreement

Product Specific Agreement or “PSA” means a separate agreement specific to each Product and/or Services entered into and mutually agreed from time to time by duly authorized representatives of the Parties. Each PSA shall be governed by and be integrated into this MSA and may include, without limitation, details such as (i) a scope of work of the Services to be performed under such PSA which describes key activities and assumptions, (ii) the Product for which Samsung will perform such Services for Client, (iii) fees to be paid to SBL by Client for the Services, and (iv) any other deliverables.
Sample 1

Related to Product Specific Agreement

  • Product Specifications means the specifications, features and/or terms of any "Contract" (as defined in the LME Rules) listed for trading on the LME, as described in the LME Rules;

  • Quality Agreement has the meaning set forth in Section 9.6.

  • Supply Agreement has the meaning set forth in Section 7.1.

  • Manufacturing Process means any process for—

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • API means American Petroleum Institute.

  • cGMP means current Good Manufacturing Practice as set forth in the United States Federal Food, Drug, and Cosmetic Act, as amended, and includes all rules and regulations promulgated by the FDA thereunder.