Bulk Drug Specifications definition

Bulk Drug Specifications means the qualitative, quantitative, functional and analytical specifications (including in-process specifications) developed by or on behalf of Trubion that describe testing methods and acceptance criteria for Bulk Drug and in-process Bulk Drug, as such specifications may be amended from time to time by the Parties in accordance with Section 6.2, including without limitation such amendments as may be required to obtain or maintain approval from the FDA, EMEA, and other regulatory authorities. A copy of the Bulk Drug Specifications, current as of the Effective Date, is attached as Exhibit E. Bulk Drug Specifications are a type of Specifications.
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Bulk Drug Specifications means the written specifications for Bulk Drug Substance set forth in Exhibit A as amended from time to time pursuant to Subparagraph 6.1.
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Bulk Drug Specifications means the specifications for the manufacture of the Bulk Drug set forth in Exhibit C-1, as such specifications may be amended from time to time either: (a) by mutual written agreement of the Parties; (b) in response to directives issued by a relevant governmental authority in connection with an Application for Regulatory Approval or marketing of the Finished Product in a particular jurisdiction; or (c) if applicable, based upon the decision of the Development Committee to pursue the Abbott Formulated Product or the NaPro Oral Formulated Product in addxxxxx to or in lieu of the NaPro Formulated Product. "Business Day" shall mean any day of the week other than a Saturday, Sunday or any other day on which commercial banks in the City of Chicago are authorized to close.
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Examples of Bulk Drug Specifications in a sentence

  • Lonza shall provide sufficient and suitable storage facilities that meet the Bulk Drug Specifications for Bulk Drug and raw materials and components.

  • Section 6.2 of this Agreement sets forth the notification and approval procedure for changes to the Bulk Drug Specifications or the Manufacturing Process.

  • Such stability testing shall include testing to validate the lead times for shipment, the shelf life of Bulk Drug, and the Bulk Drug Specifications applicable to shipment, storage and handling of Bulk Drug.

  • Cubist warrants to Abbott that Bulk Drug supplied to Abbott hereunder shall meet the Bulk Drug Specifications.

  • Pursuant to this Agreement and the Tech Transfer Agreement, Immunex shall promptly disclose to Genentech the Manufacturing Process for the Bulk Drug and the Bulk Drug Specifications and other specifications related thereto, in order to enable Genentech to fulfill its obligations under this Agreement.

  • Such stability testing shall include testing to validate the lead times for shipment, the shelf life of Bulk Drug and the Bulk Drug Specifications applicable to shipment, storage and handling of Bulk Drug.

  • Cubist further warrants to Abbott that Bulk Drug supplied to Abbott hereunder shall meet the Bulk Drug Specifications set forth on Exhibit 1.2. Cubist further guarantees that all Product Specifications Cubist provides to Abbott shall conform with the appropriate Cubist filing with either the FDA or its foreign equivalent.

  • In the event that such recall results from the failure of the Bulk Drug Substance to meet the Bulk Drug Specifications, and such failure could not reasonably be detected by Magainin within the forty-five (45) day acceptance period set forth in Xxxxxxxxx 0, Xxxxxx shall be responsible for all expenses of the recall.

  • Capacity Developmenta) Have you been trained how to use/maintain the NFI items you received?b) If not what would you have preferred to be trained on?c) What has been done to help you to address these capacity gaps?4.

  • Subject to Section 4.4, Genentech shall provide ------------------ ----------- sufficient and suitable storage facilities that meet the Bulk Drug Specifications for Bulk Drug and raw materials.


More Definitions of Bulk Drug Specifications

Bulk Drug Specifications means specifications developed by Immunex for ------------------------ Bulk Drug as set forth in the Product sBLA, including, without limitation, testing methods and acceptance criteria for each Batch generated, a summary of which is attached to the Quality Agreement, as such specifications may be amended from time to time in accordance with Section 6.2 hereof, ----------- including, without limitation, such amendments as * Portions of this exhibit have been omitted pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. The omitted portions of this exhibit have been filed separately with the SEC. may be required to obtain approval from the FDA and other applicable regulatory authorities in the United States.
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Bulk Drug Specifications means specifications developed by Genentech for Bulk Drug, including, without limitation, testing methods and acceptance criteria for each Batch generated, a summary of which is attached to the Quality Agreement, as such specifications may be amended from time to time in accordance with Article 8 hereof, including, without limitation, such amendments as may be required to obtain and/or maintain Regulatory Approval in the Territory.
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Bulk Drug Specifications means the detailed description and parameters of Bulk Drug set forth on Exhibit 1.2.
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Bulk Drug Specifications means specifications developed by Immunex for
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Bulk Drug Specifications means the detailed description and parameters of Bulk Drug set forth on Exhibit 1.2. * Confidential treatment requested: Material has been omitted and filed with the Commission.
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Related to Bulk Drug 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;

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

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

  • 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.

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

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

  • 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.

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

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

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

  • 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.

  • 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.

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

  • 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.

  • 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;

  • 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.

  • 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;

  • 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.

  • Manufacturing Process means any process for—

  • 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;

  • 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.

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

  • API means American Petroleum Institute.

  • GMP means the amount proposed by Contractor and accepted by Owner as the maximum cost to Owner for construction of the Project in accordance with this Agreement. The GMP includes Contractor’s Construction Phase Fee, the General Conditions Cost, the Cost of the Work, and Contractor’s Contingency amount.