Finished Product Specifications definition

Finished Product Specifications means the specifications of the Finished Product attached to the Supply Agreement as Schedule 2.3.1(c) thereto, as such Finished Product Specifications may be amended from time to time.
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Finished Product Specifications means the specifications set forth on Schedule B with which the Finished Product will comply.
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Finished Product Specifications means the specifications for the Finished Product approved by the Joint Development Committee in consideration of the regulatory requirements in the Territory, and such other packaging and labeling specifications as are agreed upon by the Joint Development Committee or the Parties, as the case may be, for the Finished Product, as may be amended from time to time.
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Examples of Finished Product Specifications in a sentence

  • Further, this is also contrary to section 5.3.3 of the final procedure you provided with your November 30, 2016, letter, Establishing Finished Product Specifications, which states that product specifications will include specification ranges.

  • The final version of the SOP, "Establishing Finished Product Specifications," is not adequate.

  • If Dicerna reasonably determines that the final formulated Product does not meet the agreed-upon Finished Product Specifications, then Dicerna shall provide Protiva with notice of the same.

  • Documents required: Finished Product Specifications; Lab Test Report Required indicating isopropanol or ethanol assay result; Pictures of the product packaging clearly showing the information on the front and back labels; MSDS (Material Safety Data Sheet); Tests supporting claimed efficacy according to the relevant international standard used (e.g. EN 14476, EN 1500, ASTM E2755).

  • Contemporaneously herewith, Dial has furnished to ConAgra a copy of all Finished Product Specifications for the SHELF-STABLE PRODUCTS sold as of the date of the execution of this License Agreement (a list of all such products is set forth in Schedule 10(a) hereto and includes a product description for each complete with the respective SKU or UPC for each), all of which are hereby approved.

  • If Patheon manufactures Product in accordance with the agreed upon process specifications, the Specifications, cGMPs, Applicable Laws and the terms and conditions of this Agreement, and a batch or portion of batch of Product does not meet the Finished Product Specifications, Client will not reject the non-conforming Product solely on account of such failure to meet the Finished Product Specifications.

  • CKE shall purchase from the Company and the Company shall produce the Products in accordance with its proprietary formula (the "Formula", attached as Exhibit A to the Amended and Restated Formula Development Agreement of even date) and with CKE's Finished Product Specifications attached to this Agreement and sell to CKE and Distributor the Products set forth in the DPS, as amended from time to time, in the amounts set forth in the DPS.

  • If such independent laboratory confirms that such shipment did conform to the Finished Product Specifications and all Laws, Rules and Regulations or the Parties agree or it is determined there was Naturo Non‐Fault, Naturo shall bear no costs and BevCanna shall pay for the Finished Product in question and the replacement Finished Product as otherwise provided in this Agreement.

  • Allergan shall, promptly upon receipt of each shipment of Finished Product perform customary inspection in accordance with the applicable Finished Product Specifications.

  • Ista shall evaluate and inspect each batch of Finished Product in accordance with Packaging guidelines set forth in the Finished Product Specifications and will provide Allergan with a Product lot release.


More Definitions of Finished Product Specifications

Finished Product Specifications means the specifications for the Finished Product set forth in an applicable and approved Marketing Approval Application (as defined below) and the key terms of which are set forth in Exhibit A attached hereto, including (as applicable) statements of pharmaceutical manufacturing, Labeling, filling, Packaging, storage and quality control procedures, and labeling and packaging specifications (as such may be revised from time to time in accordance with the terms of this Agreement by written agreement executed by the parties).
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Finished Product Specifications means specifications developed by Immunex and Wyeth as set forth in the Product BLA that describe testing methods and acceptance criteria for Finished Product, and which are attached hereto as EXHIBIT C, 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 Finished Product from the FDA, EMEA and other regulatory authorities in the Territory. 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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Finished Product Specifications means the specifications for the manufacture of a Finished Product, which specifications shall be established by mutual agreement of the Parties pursuant to and as a result of the Development Plan, as such specifications may be amended from time to time, either: (a) by mutual written agreement of the Parties; or (b) in response to directives issued by a relevant governmental authority in connection with the registration or marketing of the Finished Product in a particular jurisdiction. As of the Effective Date, Preliminary Finished Product Specifications are attached as Exhibit C-2, which Preliminary Finished Product Specifications shall be replaced by the Finished Product Specifications, once established pursuant to the Development Plan. "First Commercial Sale" shall mean the date of the first sale following Regulatory Approval of Finished Product in the United States by Abbott, its Affiliates or distributors to a wholesaler or any End-Usex Xxxxomer, excluding any sales or transfers of Finished Product: (a) by Abbott to its Affiliates or distributors; (b) by Abbott's Affiliates xx xxxtributors; or (c) to any Party or Third Parxx xx xxnnection with pre-clinical evaluation, clinical trials or regulatory or safety testing. "GMP" shall mean current good manufacturing practices as required by the Act and any other regulations of any governmental authority in any country whose approval is required to manufacture and sell the Product in the Territory. [THIS PORTION HAS BEEN REDACTED.] "IND" shall mean an Investigational New Drug Application, as defined in the Act, and any equivalent applications filed outside the United States in the Territory in
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Finished Product Specifications means the written specifications for each Finished Product (including any inactive ingredients used to manufacture such Finished Product), 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 1.22.
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Finished Product Specifications means the written specifications for each Finished Product (including any inactive ingredients used to manufacture such Finished Product), which are attached hereto as Exhibit 1.12.
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Finished Product Specifications means specifications for Finished Product, including, without limitation, testing methods, packaging, labeling, dosage and acceptance criteria, as approved by the FDA.
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Related to Finished Product Specifications

  • 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.

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

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

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

  • 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.

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

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • API means the American Petroleum Institute.

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

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

  • 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.

  • 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.

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

  • 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.

  • 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;

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

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

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

  • 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 means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • 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;

  • Product Labeling means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, (a) the Regulatory Authority-approved full prescribing information for such Licensed Product for such country or other jurisdiction, including any required patient information, and (b) all labels and other written, printed, or graphic matter upon a container, wrapper, or any package insert utilized with or for such Licensed Product in such country or other jurisdiction.

  • Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.