Bulk Product Specifications definition

Bulk Product Specifications means the manufacturing and quality specifications for the Bulk Product, including, without limitation, unit descriptions established from time to time in accordance with section 3.01 of the Supply Agreement.
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Bulk Product Specifications means the set of analytical methods and corresponding values and limits for the quality control of the identity, purity and content of the Bulk Product, as set forth in Schedule A.2 of the Quality Agreement and as approved by FDA. The Parties may at any time amend, replace or update the Bulk Product Specifications subject to prior written mutual agreement and subject to Section 5.6.
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Bulk Product Specifications means the specifications set forth on Schedule A with which the Bulk Product will comply.
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Examples of Bulk Product Specifications in a sentence

  • SELLER is to pay an auction selling commission as per the Auction Listing Contract.

  • If such documentation is not reasonably acceptable to SAVIENT, BTG will cooperate in taking such steps as SAVIENT may reasonably require to ensure that the documentation, and any Processing described therein complies with the Bulk Product Specifications and all Legal Requirements.

  • Such documents include, but are not limited to Bulk Product Specifications (including specifications for intermediate), Product Specifications (including specifications for product, component and packaging).

  • The Commercial Bulk Product Specifications shall be incorporated into this Agreement by formal amendment as Exhibit C-1 and shall be the controlling standards for the manufacture of Bulk Product pursuant to this Agreement unless and until they are changed by written agreement between the parties.

  • Savient’s notices of any non-conforming Bulk Product shall specify the manner in which the Bulk Product fails to meet the Commercial Bulk Product Specifications,.

  • The Parties are agreed that the Current Provisional Bulk Product Specifications may still be subject to modification based on the outcome of the Validation, as defined and performed pursuant to the Development Agreement, and subject to the mutual agreement of the parties, such agreement not to be unreasonably conditioned, delayed or withheld.

  • Without in any way limiting the foregoing, any modifications to the Commercial Bulk Product Specifications required by any Regulatory Agency with jurisdiction to require such modifications shall be made in accordance therewith.

  • BTG shall perform quality testing using assays proposed by BTG and acceptable to Savient (which acceptance shall not be unreasonably conditioned, withheld or delayed) in order to assure that the Bulk Product complies with the Commercial Bulk Product Specifications, and shall retain samples of Bulk Product produced and records of the tests made on each such batch in accordance with applicable Legal Requirements.

  • The Current Provisional Bulk Product Specifications are attached as Exhibit C.

  • In determining the Commercial Bulk Product Specifications, the Parties shall take into consideration particularly (i) the results of the subsequent development activity of BTG under the Development Agreement and (ii) the results of the Validation as defined and performed pursuant to the Development Agreement.


More Definitions of Bulk Product Specifications

Bulk Product Specifications means those specifications for Bulk Product set forth in Exhibit A attached hereto as may be amended or supplemented from time to time in accordance with Sections 6.1 and 6.2.
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Bulk Product Specifications means the specifications for the composition, testing, packaging and labeling of the Bulk Product.
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Bulk Product Specifications means, as of the Effective Date, the quality release and quality assurance specifications of the Bulk Product as described in Schedule 1.1 and, after the Effective Date, as approved by the FDA and as amended by mutual agreement of the Parties from time to time subject to the provisions hereof, together with the specifications of any Line Extensions and Improved Products included into this Agreement pursuant to Section 2.4, if and when relevant.
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Related to Bulk Product Specifications

  • 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:

  • 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.

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • 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.