Active Ingredient Specifications definition

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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Active Ingredient Specifications means the specifications for the Active Ingredient attached hereto as Exhibit 2 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 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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Examples of Active Ingredient Specifications in a sentence

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

  • Active Ingredient 1.2 Active Ingredient Specifications 1.3 Affiliate 1.4 Authority 1.5 Batch 1.6 Calendar Quarter 1.7 Certificate of Analysis 1.8 Commercially Reasonable Efforts 1.9 Commercial Value 1.10 Facility 1.11 GMP 1.12 Manufacturing 1.13 Marketing Authorization 1.14 Packaging 1.15 Preparation for Shipment 1.16 Primary Packaging 1.17 Processing 1.18 Product 1.19 Raw Materials 1.20 Scaling-Up 1.21 Secondary Packaging 1.22 Product Specifications 1.23 Technical Information II.

  • 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.

  • 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).

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

  • 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).

  • Hals▇▇ ▇▇▇ll manufacture the Active Ingredient in conformity with the Active Ingredient Specifications and in accordance with all applicable laws and regulations.

  • 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.

  • 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.


More Definitions of Active Ingredient Specifications

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. The Contract Specifications appear on the Website.

  • 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 the document referred to in:

  • Active Ingredient means the clinically active material(s) that provide pharmacological activity in a pharmaceutical product (excluding formulation components such as coatings, stabilizers, excipients or solvents, adjuvants or controlled release technologies).

  • Technical Specifications A specification in a document defining the characteristics of a product or a service, such as the quality levels, the environmental and climate performance levels, the design for all needs, including accessibility for people with disabilities, and the evaluation of conformity, of product performance, of the use of the product, safety or dimensions, as well as requirements applicable to the product as regards the name by which it is sold, terminology, symbols, testing and test methods, packaging, marking or labelling, instructions for use, the production processes and methods at every stage in the life cycle of the supply or service, as well as the evaluation and conformity procedures;