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 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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Examples of Bulk Product Specifications in a sentence

  • Allos agrees to make no changes to the API Specifications or the Bulk Product Specifications without following the procedures set forth in this Section 6.1 or Section 6.2. Allos will notify MMCO in writing at least [***] prior to filing any planned changes in the [***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

  • Any change to the API Specifications and/or Bulk Product Specifications existing as of the effective date of the Clinical Supply Agreement, must be agreed upon by both Spectrum and Topotarget in writing.

  • Allos will maintain a system (consistent with standard industry practice) to control and implement changes to API Specifications and Bulk Product Specifications, manufacturing processes and qualification procedures, in accordance with GMPs and other applicable Laws in the United States, the European Countries or under ICH Guidelines.

  • Within [***] after delivery of Bulk Product to MMCO in accordance with Section 3.8(b), if for any reason MMCO becomes aware that such Bulk Product did not conform to the Bulk Product Specifications, master batch record or relevant Bulk Product SOPs at the time of delivery, then MMCO will have the right to reject such defective shipment of the Bulk Product by giving written notice of rejection to Allos and specify the grounds for such rejection within such [***] period.

  • Any costs associated with changes to the API Specifications and Bulk Product Specifications procured by Allos for its own use required by Regulatory Authorities in the U.S. or Canada will be [***] unless such changes are also required by Regulatory Authorities in the Licensed Territory, in which case [***].


More Definitions of Bulk Product Specifications

Bulk Product Specifications means the specifications set forth on Schedule A with which the Bulk Product will comply.
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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 a product specification for a Medical Device set out in Schedule 2;

  • 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.

  • 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.

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

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

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

  • 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:

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

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

  • cGMPs means current good manufacturing practices as described in Parts 210 and 211 of Title 21 of the United States’ Code of Federal Regulations, together with the latest FDA guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time;

  • 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.

  • Manufacturing Process means any process for—

  • cGMP means current Good Manufacturing Practice as set forth in the United States Federal Food, Drug, and Cosmetic Act, as amended, and includes all rules and regulations promulgated by the FDA thereunder.

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

  • 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.

  • API means American Petroleum Institute.

  • 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.

  • 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;

  • 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.

  • Manufacturing Site means a location where a manufacturing

  • 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;

  • 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.

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

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