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.

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.

Examples of Finished Product Specifications in a sentence

Service Providers warrant to Buyers that any Products manufactured hereunder will be manufactured in accordance with the Finished Product Specifications.
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.
Service Providers shall perform the following manufacturing services (the “Manufacturing Services): • Manufacture and package the Products in accordance with the Finished Product Specifications.
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.
HARDEE’S 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 HARDEE’S Finished Product Specifications attached to this Agreement and sell to HARDEE’S and Distributor the Products set forth in the DPS, as amended from time to time, in the amounts set forth in the DPS.
HARDEE'S 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 HARDEE'S Finished Product Specifications attached to this Agreement and sell to HARDEE'S and Distributor the Products set forth in the DPS, as amended from time to time, in the amounts set forth in the DPS.
Recordati, Recordati's Nominee or the Second Source shall immediately notify Ascent in the event that Recordati or Recordati's Nominee or the Second Source, if applicable, becomes aware of any failure of the Finished Product supplied to Ascent to meet the Finished Product Specifications or other standards set forth in this Section 2.4 or in the event that Recordati or Recordati's Nominee or the Second Source becomes aware of any defect in Finished Product supplied to Ascent.
The Manufacturer shall manufacture, assemble, handle, package, and ship the Products, strictly in conformity with the Finished Product Specifications and Quality Assurance Standards (the "Specifications and Standards"), which are attached hereto as Exhibit A and made part of this Manufacturing Agreement.
Notwithstanding the foregoing, Genentech shall have the right, but not the obligation, to perform its own testing on samples from any particular Batch of API or Finished Product or any individual shipment of Finished Product, at its own discretion utilizing the analytical methods referenced in the API and/or Finished Product Specifications.

More Definitions of Finished Product Specifications

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-Use▇ ▇▇▇▇omer, excluding any sales or transfers of Finished Product: (a) by Abbott to its Affiliates or distributors; (b) by Abbott's Affiliates ▇▇ ▇▇▇tributors; or (c) to any Party or Third Par▇▇ ▇▇ ▇▇nnection 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

Finished Product Specifications means specifications for Finished Product, including, without limitation, testing methods, packaging, labeling, dosage and acceptance criteria, as approved by the FDA.

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).

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.

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.