Bulk Drug Substance Specifications definition

Bulk Drug Substance Specifications means the written specifications for Bulk Drug Substance set forth in Exhibit B as modified from time to time pursuant to Section 7.5.
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Bulk Drug Substance Specifications means the specifications for Bulk Drug Substance that are included in the Manufacturing Requirements Document.
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Bulk Drug Substance Specifications means a list of the analytical testing methods or references to analytical procedures and corresponding acceptance criteria (numerical limits, ranges or other criteria for the tests described), to be performed on each Batch of the purified Bulk Drug Substance prior to its disposition. Bulk Drug Substance Specifications shall be set forth in the XXXX document for the Bulk Drug Substance, which shall be agreed upon by CLIENT and XXXX prior to any Production of Bulk Drug Substance.
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Examples of Bulk Drug Substance Specifications in a sentence

  • Abbott shall manufacture Bulk Drug Substance in accordance with the Bulk Drug Substance Specifications that the Parties shall mutually develop.

  • Abbott warrants to Seattle Genetics that Bulk Drug Substance delivered to Seattle Genetics pursuant to this Agreement (other than pursuant to Section 6.1) shall have been manufactured pursuant to cGMPs, the Batch Records shall conform with the Bulk Drug Substance Specifications, shall have been manufactured in compliance with this Agreement and all applicable laws and regulations and shall be free from defects in materials and workmanship.

  • A Certificate of Analysis for each batch delivered shall set forth the items tested, Bulk Drug Substance Specifications, and test results.

  • Client and XXXX will mutually agree on Bulk Drug Substance Specifications ahead of any production batch.

  • Failure to provide such written notice and return the Batch for further testing by XXXX shall constitute an irrevocable acceptance by CLIENT of such Batch and an admission that the Batch meets Bulk Drug Substance Specifications.

  • Abbott shall not ship any Bulk Drug Substance that does not conform to the Bulk Drug Substance Specifications.

  • Within […***…] business days following receipt by CLIENT of the Batch Documentation for a given batch of Bulk Drug Substance, CLIENT shall determine whether the production run was in compliance with CGMP and whether the Bulk Drug Substance conforms to the Bulk Drug Substance Specifications and shall notify XXXX of said acceptance or non-acceptance of the Bulk Drug Substance.

  • Lilly and Ophidian shall meet and attempt to agree whether the Bulk Drug Substance conforms to the Bulk Drug Substance Specifications.

  • Subject to the provisions of Section 9.8(b), Seattle Genetics has the right to reject and return, at the expense of Abbott, any portion of any shipment of Bulk Drug Substance that deviates from any Bulk Drug Substance Specifications, without invalidating any remainder of such shipment, to the extent that such deviation arises from Xxxxxx’x failure to manufacture and supply the Bulk Drug Substance in accordance with this Agreement (including, without limitation, the Bulk Drug Substance Specifications).

  • If such evaluation reveals that the Bulk Drug Substance in question complies with the Bulk Drug Substance Specifications and Abbott has complied with all the warranties in Section 13.2, then Seattle Genetics shall be deemed to have accepted delivery of such Bulk Drug Substance upon the independent laboratory issuing its opinion.


More Definitions of Bulk Drug Substance Specifications

Bulk Drug Substance Specifications means specifications developed by Immunex and Wyeth as set forth in the Product BLA for Bulk Drug Substance which describe testing methods and acceptance criteria for each Bulk Drug Substance Lot generated, and which are attached hereto as EXHIBIT A, as such specifications may be amended from time to time by mutual agreement of the Parties, including without limitation such amendments as may be required to obtain approval of the Drug Product from the FDA, EMEA (as defined herein) and other applicable regulatory authorities in the Territory (as defined herein). BIP shall not unreasonably withhold its agreement to such specification amendments after agreement of the Parties on the commercial impact of any such amendments.
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Bulk Drug Substance Specifications means the written specifications for Bulk Drug Substance set forth in Exhibit B as may be modified in writing from time to time by AltaRex pursuant to Section 8.8.
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Bulk Drug Substance Specifications means the written specifications for each Bulk Drug Substance (including any raw materials or intermediates required to manufacture such Bulk Drug Substance), to be mutually agreed upon in good faith by the Parties hereto, giving due consideration to applicable regulatory requirements and, thereafter, attached hereto as Exhibit 1.6 as modified from time to time or as subsequently agreed to by the Parties.
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Bulk Drug Substance Specifications means the specifications
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Bulk Drug Substance Specifications means the written specifications for the Bulk Drug Substance (including any raw materials or intermediates required to manufacture such Bulk Drug Substance), which are attached hereto as Exhibit 1.3, as modified from time to time pursuant to Section 8.5.
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Related to Bulk Drug Substance Specifications

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

  • 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;

  • 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.

  • Product Specification means the document referred to in:

  • 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;

  • technical specification means a document that prescribes technical requirements to be fulfilled by a product, process or service;

  • 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.

  • Service Specifications means the following documents, as applicable to the Services under Your order: (a) the Oracle Cloud Hosting and Delivery Policies, the Program Documentation, the Oracle service descriptions, and the Oracle Corporate Security Practices; (b) Oracle’s privacy policies; and (c) any other Oracle documents that are referenced in or incorporated into Your order. The following do not apply to any non-Cloud Oracle service offerings acquired under Your order, such as professional services: the Oracle Cloud Hosting and Delivery Policies and Program Documentation. The following do not apply to any Oracle- provided Software: the Oracle Cloud Hosting and Delivery Policies.

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

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Service Specification means and includes detailed description, statements to technical data, performance characteristics, and standards (Indian as well as International) 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 specifications affecting the work or any additional specification required to be produced by the Bidder 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;

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

  • 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.

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

  • Manufacturing Process means any process for—

  • Standard Specifications means all applicable legal requirements pertaining to the development of the Property including, but not limited to, Master Subdivision Plan, applicable permits, and construction drawings required for all Infrastructure, including, without limitation, the Town's Unified Development Ordinance, Knightdale's Water Allocation Policy (Ordinance # 13-06- 19-001 and Ordinance # 00-00-00-000) and Standard Specifications and Construction Details Manual. The failure of this Agreement to describe any other permit, condition, or term of restriction applicable to the Property does not relieve Developer of the necessity of complying with the same.

  • 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.

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

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

  • cGMPs means, as applicable, current good manufacturing practices as described in:

  • 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.

  • API means American Petroleum Institute.

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, set forth in this Agreement, required to manufacture Product or Products from Active Materials and Components;

  • 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: