Active Ingredient Specifications definition

Active Ingredient Specifications means the specifications for the Active Ingredient attached hereto as Exhibit 1 and made a part hereof, as determined in accordance with this Agreement, the analytical methodology set forth and in accordance with the terms and conditions of the Quality Agreement.
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Active Ingredient Specifications means the Specifications for the Active Ingredient to be used in Product, attached hereto as Schedule 1.17, as such Specifications may be amended from time to time by the JCC.
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Active Ingredient Specifications means the specifications for the Active Ingredient to be used in Product, attached hereto as Annex I, as such specifications may be amended from time to time as provided herein.
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Examples of Active Ingredient Specifications in a sentence

  • SPECIFICATIONS Active Ingredient Specifications shall mean the specifications therefor, as described in EXHIBIT 1.

  • Active Ingredient supplied by CYGNUS or its contract partners hereunder shall meet the applicable Active Ingredient Specifications, safety data sheet and relevant information concerning the safety, handling, disposal, use and environmental effect of Active Ingredient.

  • If a shipment of Active Ingredient or any portion thereof fails to conform to the Active Ingredient Specifications, then Watsxx xxxll have the right to reject such nonconforming shipment of Active Ingredient or the nonconforming portion thereof, as the case may be.

  • For greater certainty, the foregoing provisions of this Article 5 shall not apply in respect of any change in the Active Ingredient Specifications or Packaging Specifications made by SAD other than pursuant to a Generex request.

  • Halsxx xxxll manufacture the Active Ingredient in conformity with the Active Ingredient Specifications and in accordance with all applicable laws and regulations.

  • SAD shall provide Buyer with not less than three (3) months’ prior written notice of SAD’s implementation of any intended significant change(s) to its manufacturing processes for the Active Ingredient, which might affect the quality of the Active Ingredient (“Change Notice”) (e.g. any change in the Active Ingredient Specifications or Packaging Specifications made by SAD other than pursuant to a Buyer request).

  • SAD shall provide Generex with not less than six (6) months’ prior written notice of SAD’s implementation of any intended significant change(s) to its manufacturing processes for the Active Ingredient, which might affect the quality of the Active Ingredient (“Change Notice”) (e.g. Any change in the Active Ingredient Specifications or Packaging Specifications made by SAD other than pursuant to a Generex request).

  • For greater certainty, the foregoing provisions of this Article 5 shall not apply in respect of any change in the Active Ingredient Specifications or Packaging Specifications made by SAD other than pursuant to a Buyer request.

  • ANNEX I Active Ingredient Specifications [ * ] [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


More Definitions of Active Ingredient Specifications

Active Ingredient Specifications means the specifications for the Active Ingredients as set forth in a monograph for Propofol finalized by the U.S. Pharmacopeia ("USP") or in the event a monograph has not been finalized by the USP, such specifications as determined by the JMC prior to submission of the Registration Application for the Product, as such specifications may be amended from time to time by the JMC.
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Active Ingredient Specifications means the specifications for the Active Ingredient set forth in Exhibit A attached hereto, including (as applicable) statements of pharmaceutical manufacturing, filling, storage and quality control procedures, and labeling and packaging specifications (as such may be revised from time to time in accordance with the terms of this Agreement by written agreement executed by the parties). The parties acknowledge that there may be more than one form of Active Ingredient and that each such form will have its own Active Ingredient Specifications.
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Related to Active Ingredient Specifications

  • 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.

  • 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;

  • Active Ingredient means any com- ponent that is intended to furnish pharmacological activity or other di- rect effect in the diagnosis, cure, miti- gation, treatment, or prevention of dis- ease, or to affect the structure or any function of the body of humans. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.

  • Technical Specifications means the detailed requirements for the Work furnished by the Architect and set forth in Book 3 of the Contract Documents.

  • technical specification means, with respect to any Software, the document setting forth the technical specifications for such Software and included in the Statement of Work.

  • IS Specification means the Specification of latest edition with amendments, if any, up to time of receipt of tender by Corporation issued by the Bureau of Indian Standards as referred to in the specifications and / or work orders.

  • Goods Specification means any specification for the Goods, including any related plans and drawings, as set out in the Order or otherwise agreed in writing by Get Living and the Supplier;

  • Service Specifications means the following documents, as applicable to the Services under Your order:

  • Service Specification means and include detailed description, statements to technical data, performance characteristics, and standards (Indian as well as) as applicable and as specified in the Contract as well as those specifications relating to Industry standards and codes applicable to the performance of the work, work performance quality and the specifications affecting the works or any additional specification required to be produced by the DCO to meet the design criteria.

  • Functional Specifications means the descriptions of features and functions of the Application as expressly set forth in Quote.

  • TENDER SPECIFICATIONS means the Scope of Work, Special Instructions / Conditions, Technical specifications/requirement , Appendices, Site Information and drawings pertaining to the work and any other relevant reference in the Tender Document for which the Bidder are required to submit their offer.

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

  • Standard Specifications means a compilation in book form of specifica- tions approved for general application and repetitive use;

  • The Specification means the Specification annexed to or issued with G.T.C.C. and shall include the schedules & drawings attached thereto as well as all samples and pattern, if any.

  • 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;

  • 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.

  • Manufacturing Site means a location where a manufacturing

  • API means American Petroleum Institute.

  • TENDER SPECIFICATION means “Specific conditions, technical specifications, appendices, site information and drawing pertaining to the work in which the tenderers are required to submit their offer. Individual specification number will be assigned to each tender specification.

  • Specifications means the Specifications of the Works included in the Contract and any modification or addition made or approved by the Project Manager.

  • 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.

  • Brand Name Specification means a specification limited to one or more items by manufacturers’ names or catalogue number.

  • Manufacturing Process means any process for—

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

  • District Specifications means the specifications followed by the State Government in the area where the work is to be executed.