Draft Specifications definition

Draft Specifications means the preliminary written specifications established for the characteristics, and quality as well as quality control testing procedures for Drug Product or Drug Substance as the case may be, as developed and mutually approved by the Parties in accordance with the License Agreement, and attached hereto as Schedule A. Draft Specifications shall dictate the manufacture of Drug Product until such time as the Final Specifications (as hereinafter defined) are agreed to by the Parties in accordance with Section 3.2.
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Draft Specifications as used herein shall mean the preliminary specifications of the respective TARGET PRODUCT which are provided by CANON under the PROJECT. The DRAFT SPECIFICATIONS shall be expressly included in the Confidential Information (as defined in EXHIBIT C attached hereto) of CANON.
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Draft Specifications means the preliminary written specifications established for the characteristics, and quality as well as quality control testing procedures for Drug Product or Drug Substance as the case may be, as developed and mutually approved by the Parties in accordance with the License Agreement, and attached hereto as S chedule A. Draft Specifications shall dictate the manufacture of Drug Product until such time as the Final Specifications (as hereinafter defined) are agreed to by the Parties in accordance with Section 3.2.
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Examples of Draft Specifications in a sentence

  • Draft Specifications that encourage competition and provide opportunities for cost savings.

  • C.3.2.3 Development of ILSAC Draft C.3.2.3.1 Review of Proposed ILSAC Draft Specifications After agreement has been reached on the need, tests and alternatives have been identified, and timing has been established, the AOAP is charged with developing a draft specification.

  • Any (i) proposals for new Draft Specifications and Final Specifications, (ii) changes to the Formerly Adopted Specifications and/or existing Final Specifications, and/or (iii) any questions or conflicts regarding the proposals for new Draft Specifications and Final Specifications shall be submitted to the Forum Technical Working Groups for their review.

  • The Parties acknowledge that these Draft Specifications are subject to change with the collection of Batch Run manufacturing data.

  • No later than 3 business days after the conclusion of the applicable Review Period, the Chair will distribute any Exclusion Notices submitted in accordance with Section 4.2 (Review of Draft Specifications) of the IPR Policy via the Public Mail List; provided, however, that the Chair may distribute such Exclusion Notices earlier.

  • ImmunoGen shall test and release all materials for identity and quality in accordance with the Draft Specifications and Final Specifications prior to using the same.

  • All electronic and tangible copies of Draft Specifications that are subject to public comment, and all Specifications, shall include the relevant notations specified on Appendix C.

  • All Drug Product supplied to BI Pharma hereunder (i) will comply with all applicable Draft Specifications or Final Specifications at the time of manufacture and (ii) will have been manufactured in accordance with the Master Batch Records and cGMP.

  • Any Member, Contributor or Academic Contributor making a Specification Contribution to any Draft Specifications may submit an IPR Withhold Notice during the 60 day draft review period (see Section 4.4) in respect of other parts of the Draft Specifications for which it has not made a Specification Contribution that is substantively incorporated in the Final Specification.

  • ImmunoGen shall maintain, at its own expense, the Facility, (including, without limitation the equipment and the Dedicated Equipment) in a state of repair, cleanliness and operating efficiency consistent with the requirements of the Draft Specifications and Final Specifications respectively, cGMP and other applicable requirements.


More Definitions of Draft Specifications

Draft Specifications as used herein shall mean the preliminary specifications of each of the PHASE 1 TARGET PRODUCT and the PHASE 2 TARGET PRODUCT (respectively, "PHASE 1 DRAFT SPECIFICATIONS" and "PHASE 2 DRAFT SPECIFICATIONS") which are provided by CANON under PHASE 1 and PHASE 2 of the PROJECT. The DRAFT SPECIFICATIONS shall be expressly included in the Confidential Information (as defined in EXHIBIT C attached hereto) of CANON.
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Related to Draft Specifications

  • 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.

  • 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.

  • 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.

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

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

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

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

  • 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.

  • 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.

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

  • 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.

  • TENDER SPECIFICATION means “Specific conditions, technical specifications, appendices, site information and drawing pertaining to the work in which the tenderers are required to submit their offer. Individual specification number will be assigned to each tender specification.

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

  • Swap Specification means, with respect to any Swap, the Rules or other trading protocols containing specifications for such Swap, as adopted, amended, supplemented or otherwise modified from time to time by BSEF.

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

  • Specification Schedule means the Schedule containing details of the Specification.

  • Goods Specification any specification for the Goods including any relevant plans or drawings, that is agreed in writing by the Reseller and Voip-Unlimited.

  • common specifications means a document, other than a standard, containing technical solutions providing a means to comply with certain requirements and obligations established under this Regulation;

  • 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.

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

  • Class specification means a written description of a class setting forth factors and conditions which are essential characteristics of positions in that class.

  • 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;

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

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • Specifications and Standards means the specifications and standards relating to the quality, quantity, capacity and other requirements for the Project, as set forth in Schedule-D, and any modifications thereof, or additions thereto, as included in the design and engineering for the Project submitted by the Developer to, and expressly approved by, the Authority;