Exception Documentation Certificates of Analysis and Batch Records Sample Clauses

Exception Documentation Certificates of Analysis and Batch Records. PRONOVA shall provide a certificate of analysis and such other documents as shall be reasonably requested by RELIANT for any API to be released hereunder, in a form in accordance with the cGMPs and all other applicable Regulatory Requirements and the Specifications and as shall be agreed upon by the Parties. For any batch that initially failed to meet any Specification, the certificate of analysis shall document the exception. RELIANT shall be under no obligation to accept any API for delivery hereunder that shall have an expiry period after delivery which is less than half the retest period approved by FDA, provided however that if retesting after the retest period demonstrates that the API is within regulatory requirements and Specifications, RELIANT shall be obliged to accept delivery.
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Exception Documentation Certificates of Analysis and Batch Records 

Related to Exception Documentation Certificates of Analysis and Batch Records

  • Certificates of Analysis Illumina shall, once made available for all TG Consumables as part of Illumina’s standard commercial offering for TG Consumables, provide a Certificate of Analysis for each lot of TG Consumables sold to Customer under this Agreement.

  • Certificate of Analysis Seller shall provide a certificate of analysis and other documents as defined in the Quality Agreement for any Product to be released hereunder, in a form in accordance with the cGMPs and all other applicable Regulatory Requirements and Product Specifications and as shall be agreed upon by the parties. For any batch that initially failed to meet any Product Specification, the certificate of analysis shall document the exception. Products that do not meet dissolution specifications at USP Stage I and II testing shall not be accepted by Buyer (and such requirement shall be included in the Product Specifications/Quality Manual).

  • Product Documentation Supplier shall produce and deliver to Sony Ericsson Product Documentation fulfilling the requirements set out in templates included in Enclosure 2.3.

  • Complete Copies of Materials The Company has delivered or made available true and complete copies of each document (or summaries of same) that has been requested by Parent or its counsel.

  • Technical Specifications Each Bloom System is an integrated system comprised of a fuel cell stack assembly and associated balance of plant components that converts a fuel into electricity using electrochemical means that (i) has a Nameplate Capacity of at least 0.5 kilowatts of electricity using an electrochemical process and (ii) has an electricity-only generation efficiency greater than thirty percent (30%).

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • Quality Agreement Each Party will comply with the terms of the Quality Agreement in the performance of its obligations hereunder including record retention, audits and inspections, change control, adverse events and product recall. The Parties will conduct periodic Product quality reviews in accordance with the terms of the Quality Agreement.

  • Supporting Documentation Property Manager shall maintain and make available at Property Manager’s office at the address set forth in Section 18, or at the office of any local property manager or leasing company to whom Property Manager may have subcontracted its duties hereunder or at the Property, copies of the following: (a) all bank statements and bank reconciliations; (b) detailed cash receipts and disbursement records; (c) rent roll of tenants; and (d) paid invoices (or copies thereof); Property Manager shall deliver a copy of the documents described above to Company upon written request.

  • Quality Specifications SANMINA-SCI shall comply with the quality specifications set forth in its Quality Manual, incorporated by reference herein, a copy of which is available from SANMINA-SCI upon request.

  • Technical Documentation Subject to the terms of this Agreement, BROCADE hereby grants to McDATA a nonexclusive, nontransferable, worldwide license to reproduce and use BROCADE's technical documentation provided to McDATA by BROCADE hereunder, solely for McDATA's internal purposes in connection with the manufacture, marketing and support of the McDATA Products into which the Products are incorporated as set forth herein. Modifications to such technical documentation by McDATA shall require BROCADE's prior written authorization, which authorization will not be unreasonably withheld.

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