Bulk Drug Substance Specifications definition

Bulk Drug Substance Specifications means the written specifications for Bulk Drug Substance set forth in Exhibit B and as they will be further defined in the scope of this Project and as modified from time to time pursuant to Section 7.3.
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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

  • If changes occur in the Project or Bulk Drug Substance Specifications, or if technical difficulties require that Abbott perform either additional work or repeat work, and provided such work is unrelated to Xxxxxx’x fault or negligence, in advance of incorporating such changes or performing any work associated therewith, Abbott shall consult with Seattle Genetics and thereafter provide Seattle Genetics with a new or revised written test protocol with cost estimates for such work.

  • For (a) work performed in conducting the Project in accordance with this Agreement, (b) Deliverables to Seattle Genetics as specified in Exhibit C, and (c) Bulk Drug Substance that is manufactured and delivered in accordance with this Agreement and meets the Bulk Drug Substance Specifications, Abbott shall invoice Seattle Genetics according to the Payment Schedule and Bulk Drug Pricing in Exhibit D.

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

  • Each shipment of Bulk Drug Substance shall be accompanied by documentation in accordance with Exhibits B (Bulk Drug Substance Specifications) and H (Quality Agreement).

  • For the avoidance of doubt, where the specifications have not been agreed upon by the parties hereto, XXXX shall be obligated only to use its reasonable endeavors to Produce Bulk Drug Substance that meets CGMP and draft 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.

  • If, after conducting its own review, XXXX agrees, or it is determined pursuant to Section 4.2, that the returned Batch fails to meet the Bulk Drug Substance Specifications and, to the extent that such failure is not due (in whole or in part) to acts or omissions of CLIENT or any third party after pick-up of such Batch, the provisions of Section 4.3 shall apply.

  • In addition, Abbott will test and release Bulk Drug Substance to Seattle Genetics in accordance with the Bulk Drug Substance Specifications described in Exhibit B.

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


More Definitions of Bulk Drug Substance Specifications

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 specifications
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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 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 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 those Manufacturing, performance, quality - control release, and Fill/Finish specifications for Drug Substance or Licensed Product in the Territory, which are initially as set forth in the applicable Regulatory Approval for a Licensed Product, as such specifications may be amended from time to time pursuant to the terms of this Agreement.

  • 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 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.

  • 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.

  • 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.

  • 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 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;

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

  • 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.

  • Detailed Specifications means the specifications for materials and works as specified in PWD BSR/ issued under the authority of PWD/ or as implied/added to or superseded by the special conditions.

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

  • 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;

  • 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 the American Petroleum Institute.

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