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.

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.

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.