Product Specific Agreement definition

Product Specific Agreement or “PSA” is defined in Section 2.1.
Product Specific Agreement or “PSA” means a separate agreement specific to each Product and/or Services (Cell Line Development, Process Development, Manufacture of Drug Substance or Drug Product, etc.), 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.
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.

Examples of Product Specific Agreement in a sentence

  • Fibrogen - Samsung Product Specific Agreement (Clinical DS)(00000) 0000 00 00 EXECUTION CLEAN FINAL [*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.

  • In the event this Product-Specific Agreement is terminated pursuant to Article VIII of the Agreement or Article IV of this Product- Specific Agreement, payments to Participating Site shall be pro-rated to compensate Participating Site for work actually and properly performed for this Data Collection Initiative up to the actual date of termination.

  • Participating Site agrees to provide any information requested by EBMT or required to be provided according to the terms the transparency reporting outlined in this Agreement and any Product Specific Agreement, if applicable.

  • Each Data Collection Initiative performed under this Agreement and the Product Specific Agreement shall be observational in nature and any procedures performed by Participating Site are within normal clinical practice.

  • In the event this Product- Specific Agreement is terminated pursuant to Article VIII of the Agreement or Article IV of this Product-Specific Agreement, payments to Participating Site shall be pro- rated to compensate Participating Site for work actually and properly performed for this Data Collection Initiative up to the actual date of termination.

  • Subject to Xxxxxx XXX, the Parties agree that publications or presentations of any of the outcome Data from a Data Collection Initiative shall be subject to the terms of the Product Specific Agreement, as applicable, and shall be in accordance with the EBMT “Authorship guidelines for EBMT publications” available on the EBMT website, as may be amended from time to time and incorporated for reference in Annex II.

  • Participating Site represents and warrants to EBMT that it will: (i) use its best efforts in performing the services under this Agreement and any Product- Specific Agreement; (ii) conduct each Data Collection Initiative in accordance with the Framework, the relevant Product-Specific Agreement, and this Agreement; and (iii) perform each Data Collection Initiative in accordance with any and all Applicable Laws.

  • Participating Site represents and warrants to EBMT that it will: (i) use its best efforts in performing the services under this Agreement and any Product-Specific Agreement; (ii) conduct each Data Collection Initiative in accordance with the Framework, the relevant Product- Specific Agreement, and this Agreement; and (iii) perform each Data Collection Initiative in accordance with any and all Applicable Laws.

  • Client and SBL entered into a Master Services Agreement effective October 30, 2020 (the “MSA”) and a Product Specific Agreement – Clinical Product Drug Substance effective October 30, 2020 (the “PSA”).

  • If any provision of a Product- Specific Agreement conflicts with any of the provisions of this Agreement, the provisions of the Agreement will prevail, unless the Product-Specific Agreement states otherwise.


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.

Related to Product Specific Agreement

  • Product Specific Terms means the terms applicable to a specific item of Licensed Software as set out in Schedule 2;

  • 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;

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • Project Specific IPRs means: (a) IPRs in the Services provided by the Supplier (or by a third party on behalf of the Supplier) specifically for the purposes of the Contract and all updates and amendments of these items created during the Contract Period; and/or (b) IPRs arising as a result of the provision of the Services by the Supplier (or by a third party on behalf of the Supplier) under the Contract, [including the rights in or to any database developed and supplied by the Supplier to the Customer in accordance with the terms of this Contract;

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

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

  • Manufacturing Agreement has the meaning set forth in Section 4.3.

  • Contract Specifications means the principal trading terms in CFD (for example Spread, Swaps, Lot Size, Initial Margin, Necessary Margin, Hedged Margin, the minimum level for placing Stop Loss, Take Profit and Limit Orders, financing charges, charges etc) for each type of CFD as determined by the Company from time to time. The Contract Specifications appear on the Website.

  • Detailed manufacturing or process data means technical data that describe the steps, sequences, and conditions of manufacturing, processing or assembly used by the manufacturer to produce an item or component or to perform a process.

  • Manufacturing and Supply Agreement means the Manufacturing and Supply Agreement by and between Biogen and Bioverativ, in the form attached hereto as Exhibit C.

  • Clinical Supply Agreement has the meaning set forth in Section 4.2.

  • Project specific information means such part of the Instructions to Consultants used to reflect specific project and assignment conditions.

  • 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.

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Collaborative pharmacy practice agreement means a written and signed

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Product Schedule means the “Product Schedule” that forms part of the Contract.

  • Finished Products means any one or more of the following petroleum oils, or a mixture or combination of these oils, to be used without further processing except blending by mechanical means:

  • Contract Specific Goals means the subcontracting goals for MBE and WBE participation established for a particular contract.

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • End User License Agreement means a license grant or end user license agreement governing software as further described in this Agreement or any applicable Appendix.

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

  • API means the American Petroleum Institute.

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.