Commercial Bulk Product Specifications definition

Commercial Bulk Product Specifications means the manufacturing and quality specifications for the Bulk Product, including, without limitation, unit descriptions established initially in accordance with Section 3.01(ii) and amended from time to time in accordance with Section 3.01(iii) .
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Examples of Commercial Bulk Product Specifications in a sentence

  • The initial Commercial Bulk Product Specifications shall be agreed upon in writing by the Parties, as soon as reasonably practicable after the conclusion of the Validation, as defined and performed pursuant to the Development Agreement, but in no event later than ninety (90) days from the conclusion of the Validation, unless the Parties shall mutually agree to extend such time period (hereinafter the “Commercial Bulk Product Specifications”).

  • In addition, except as otherwise agreed by the Parties in writing, no Bulk Product shall be delivered until such Bulk Product has been processed in accordance with the tests, inspections and controls required under the Commercial Bulk Product Specifications and such other tests as the Parties may mutually agree upon in writing; provided, however, that the foregoing shall not relieve BTG of its obligation under ARTICLE 5.

  • BTG shall perform quality testing using assays proposed by BTG and acceptable to Savient (which acceptance shall not be unreasonably conditioned, withheld or delayed) in order to assure that the Bulk Product complies with the Commercial Bulk Product Specifications, and shall retain samples of Bulk Product produced and records of the tests made on each such batch in accordance with applicable Legal Requirements.

  • In determining the Commercial Bulk Product Specifications, the Parties shall take into consideration particularly (i) the results of the subsequent development activity of BTG under the Development Agreement and (ii) the results of the Validation as defined and performed pursuant to the Development Agreement.

  • Without in any way limiting the foregoing, any modifications to the Commercial Bulk Product Specifications required by any Regulatory Agency with jurisdiction to require such modifications shall be made in accordance therewith.

  • Except as set forth in this Section 6.02, BTG shall not make any change to the Process for the Bulk Product that would have an impact on the Bulk Product or Product, result in a change to the Commercial Bulk Product Specifications or the Product Specifications or require submissions to or approvals from any Regulatory Agency, except by prior written approval of Savient for such change, which approval shall not be unreasonably conditioned, withheld or delayed.

  • The Commercial Bulk Product Specifications shall be incorporated into this Agreement by formal amendment as Exhibit C-1 and shall be the controlling standards for the manufacture of Bulk Product pursuant to this Agreement unless and until they are changed by written agreement between the parties.

  • At Savient’s election, Bulk Product may be subjected to testing by Savient at Savient’s facilities or facilities of a Third Party designated by Savient in order to verify conformance with the Commercial Bulk Product Specifications, using assays proposed by BTG and acceptable to Savient (which acceptance shall not be unreasonably conditioned, withheld or delayed).

  • Savient and BTG acknowledge and agree that, due to additions or modifications to the Current Commercial Bulk Product Specifications, additional experience manufacturing Bulk Product may be required in order to provide a higher level of assurance that Bulk Product can be consistently manufactured in a manner that conforms to the Current Commercial Bulk Product Specifications as set forth in Exhibit C-1 hereto.

  • After the acceptance by such Regulatory Authorities of any revisions to the Current Commercial Bulk Product Specifications as set forth in Exhibit C-1 hereto, unless the Parties mutually agree otherwise in writing, the risk of failed batches and payment terms set forth in the Agreement (as amended by Section 2(b) above) shall apply, in full force and effect, with respect to all future Bulk Product manufactured by BTG pursuant to the Agreement.

Related to Commercial Bulk Product Specifications

  • Product Specifications means those product, labeling and performance specifications for the Product filed with and approved by the relevant Regulatory Authority, including Product formulae, labeling, and materials required for the manufacture of the Product that is to be purchased and supplied under this Agreement, as such are set forth on Schedule 1.25, which specifications may be amended by the Parties from time to time in accordance with this Agreement.

  • 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. The Contract Specifications appear on the Website.

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

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

  • 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.

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

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

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

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

  • Finished Products means the fully assembled and shrink-wrapped Licensed Products, each including a Game Cartridge, Game Cartridge label and Printed Materials.

  • Manufacturing Process means any process for—

  • 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.

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

  • 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.

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

  • API means American Petroleum Institute.

  • Project specific information means such part of the Instructions to Consultants used to reflect specific project and assignment conditions.

  • 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

  • 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 Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.