Manufacturer’s Release Sample Clauses

Manufacturer’s Release. SPECIFICATIONS shall mean the defined list of analytical test methods that BI is responsible for performing, and acceptance criteria for a PRODUCT and DRUG SUBSTANCE, as set forth in Exhibit 1 and Exhibit 2, as applicable, to all of which a PRODUCT or DRUG SUBSTANCE must conform to in order to be considered acceptable for the disposition of the PRODUCT or DRUG SUBSTANCE for the intended use. Such MANUFACTURER’S RELEASE SPECIFICATIONS may be amended, supplemental or otherwise modified by the Parties from time to time in accordance with the terms of this AGREEMENT and the QUALITY ASSURANCE AGREEMENT as applicable.
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Manufacturer’s Release. The release of the API by Formosa’s Quality Assurance Unit. Release signifies that the material has been produced using approved processes, in compliance with cGMP regulations and meets the established specifications as determined by Formosa QA’s review of all relevant documentation.
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Manufacturer’s Release. 9.6.1.1 The SUBCONTRACTOR’s Quality Assurance must review all batch production and test records including label reconciliation, environmental monitoring data and trends, deviations and investigations. The SUBCONTRACTOR’S QA must confirm that the process was executed according to established requirements and that any deviations, etc. have been satisfactorily identified (documented) and addressed. 9.6.1.1.1 The SUBCONTRACTOR has the authority to reject batches, however, the SUBCONTRACTOR will notify SAIC-XXXXXXXXX, INC.’s Technical and QA Contact of any batch being considered for rejection prior to the decision for rejection. A meeting of the Quality Review Board may be convened to discuss this issue and explore possible courses of action. 9.6.1.2 The SUBCONTRACTOR must provide a Certificate of Analysis to SAIC-XXXXXXXXX, INC. which includes: • Name and address of manufacturer • Name of product (or product description) • Batch or lot number • Date of manufacture • Quantity (# units and unit volume) available for the clinic • Expiration date or re-test date based on stability data (if applicable) • A list of each test performed, method description, specification and result. • Review and approval signatures (Manufacturing or QC) and QA 9.6.1.3 The SUBCONTRACTOR must provide a Certificate of Conformance to SAIC-XXXXXXXXX, INC. that verifies that the product was manufactured in compliance to cGMPs. 9.6.1.4 The SUBCONTRACTOR must provide a copy of the batch production and control record and all supporting documents including, but not limited to: • QA reviewed batch record and buffer preparation records. • All raw data and final reports for in-process and release tests, including all associated OOS reports • Certificates of Analysis, and Certificates of Origin (or source origin statements), when applicable, for all raw materials, components and component closures • Environmental and personnel monitoring data and/or trends • Sterilization and depyrogenation records • Label issuance and reconciliation records • Filter integrity test results for sterilizing filter • Transaction history (inventory at date of manufacture and all changes in inventory subsequent to that date) for bulk drug substance and/or finished drug product. • Product storage monitoring data • Copy of any other documentation of any communication between SAIC-XXXXXXXXX, INC. and the SUBCONTRACTOR that have affected the manufacture or testing of the product.
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Manufacturer’s Release. 3.1 Batch review and release to the Client will be the responsibility of Patheon who shall act in accordance with Patheon’s standard operating procedures. The Client will have sole responsibility for release of the Product(s) to the market. 3.2 For each batch released by Patheon for shipment to the Client, Patheon will deliver to the Client a summary list of all deviations, and a certificate of analysis/certificate of compliance, which will include a statement that the batch has been manufactured in accordance with the Specifications, this Quality Agreement and Applicable Laws. 3.3 Patheon will notify the Client in the event of (i) any major (product impacting) deviation during manufacture which affects the quality or efficacy of the Product(s) or (ii) a confirmed out of specification (OOS) result within one (1) Business Day of such event. Patheon will provide a copy of the deviation investigation report as soon as it is available but in no case later than three (3) Business Days following such event.
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Related to Manufacturer’s Release

  • Manufacturer’s Warranty The Goods include the manufacturer’s standard limited parts warranty to replace defective parts covered under such warranty exclusive of labor. Labor is warranted by the Elevator Contractor for 90 days following installation. The manufacturer’s parts warranty may require that the Goods be maintained throughout the warranty period by an authorized manufacturer’s representative under a separate maintenance contract. Any warranty is conditioned on written notice to the Elevator Contractor within warranty period and contingent upon receipt of final payment to Elevator Contractor.

  • ODUF Packing Specifications 6.3.1 A pack will contain a minimum of one message record or a maximum of 99,999 message records plus a pack header record and a pack trailer record. One transmission can contain a maximum of 99 packs and a minimum of one pack.

  • Packing Specifications 7.3.1 A pack will contain a minimum of one message record or a maximum of 99,999 message records plus a pack header record and a pack trailer record. One transmission can contain a maximum of 99 packs and a minimum of one pack.

  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

  • PRODUCT MANUFACTURER'S SUPPLIERS Only those dealers/distributors listed by the manufacturer will be considered authorized to act on behalf of the Product Manufacturer.

  • Manufacturer’s Warranties If a Lease Vehicle is covered by a Manufacturer’s warranty, the Lessee, during the Vehicle Term for such Lease Vehicle, shall have the right to make any claims under such warranty that the Lessor could make.

  • Product Warranty Seller provides general warranties of fitness and general warranties that the goods are free from defects, for 1 year from acceptance of the goods, except as may otherwise be set forth in the Description/Proposal, or other attached warranty.

  • Escrow Format Specification Deposit’s Format. Registry objects, such as domains, contacts, name servers, registrars, etc. will be compiled into a file constructed as described in draft-xxxxx-xxxxxxx-registry-data-escrow, see Part A, Section 9, reference 1 of this Specification and draft-xxxxx-xxxxxxx-dnrd-objects-mapping, see Part A, Section 9, reference 2 of this Specification (collectively, the “DNDE Specification”). The DNDE Specification describes some elements as optional; Registry Operator will include those elements in the Deposits if they are available. If not already an RFC, Registry Operator will use the most recent draft version of the DNDE Specification available at the Effective Date. Registry Operator may at its election use newer versions of the DNDE Specification after the Effective Date. Once the DNDE Specification is published as an RFC, Registry Operator will implement that version of the DNDE Specification, no later than one hundred eighty (180) calendar days after. UTF-8 character encoding will be used.

  • Drug-Free Workplace Certification As required by Executive Order No. 90-5 dated April 12, 1990, issued by the Governor of Indiana, the Company hereby covenants and agrees to make a good faith effort to provide and maintain a drug-free workplace at the Project Location. The Company will give written notice to the IEDC within ten (10) days after receiving actual notice that the Company, or an employee of the Company in the State of Indiana, has been convicted of a criminal drug violation occurring in the workplace. False certification or violation of this certification may result in sanctions including, but not limited to, suspension of payments under the Agreement, termination of the Agreement and/or debarment of contracting opportunities with the State for up to three (3) years. In addition to the provisions of the above paragraph, if the total amount set forth in the Agreement is in excess of $25,000.00, the Company agrees that it will provide a drug-free workplace by: A. Publishing and providing to all of its employees a statement notifying them that the unlawful manufacture, distribution, dispensing, possession or use of a controlled substance is prohibited in the Company’s workplace, and specifying the actions that will be taken against employees for violations of such prohibition;

  • Product Specifications (a) Supplier shall manufacture all Products according to the Specifications in effect as of the date of this Agreement, with such changes or additions to the Specifications of the Products related thereto as shall be requested by Buyer in accordance with this Section or as otherwise agreed in writing by the Parties. All other Products shall be manufactured with such Specifications as the Parties shall agree in writing. (b) Buyer may request changed or additional Specifications for any Product by delivering written notice thereof to Supplier not less than one hundred twenty (120) days in advance of the first Firm Order for such Product to be supplied with such changed or additional Specifications. Notwithstanding the foregoing, if additional advance time would reasonably be required in order to implement the manufacturing processes for production of a Product with any changed or additional Specifications, and to commence manufacture and delivery thereof, Supplier shall so notify Buyer, and Supplier shall not be required to commence delivery of such Product until the passage of such additional time. (c) Supplier shall be required to accommodate any change of, or additions to, the Specifications for any Product, if and only if (i) in Supplier’s good faith judgment, such changed or additional Specifications would not require Supplier to violate good manufacturing practice, (ii) the representation and warranty of Buyer deemed made pursuant to Subsection (e) below is true and correct, and (iii) Buyer agrees to reimburse Supplier for the incremental costs and expenses incurred by Supplier in accommodating the changed or additional Specifications, including the costs of acquiring any new machinery and tooling. For the avoidance of doubt, such costs and expenses shall be payable by Buyer separately from the cost of Products at such time or times as Supplier shall request. (d) Supplier shall notify Buyer in writing within thirty (30) days of its receipt of any request for changed or additional Specifications (i) whether Supplier will honor such changed or additional Specifications, (ii) if Supplier declines to honor such changed or additional Specifications, the basis therefor and (iii) if applicable, the estimated costs and expenses that Buyer will be required to reimburse Supplier in respect of the requested changes or additions, as provided in Subsection (c) above. Buyer shall notify Supplier in writing within fifteen (15) days after receiving notice of any required reimbursement whether Buyer agrees to assume such reimbursement obligation. (e) By its request for any changed or additional Specifications for any Product, Buyer shall be deemed to represent and warrant to Supplier that the manufacture and sale of the Product incorporating Buyer’s changed or additional Specifications, as a result of such incorporation, will not and could not reasonably be expected to (i) violate or conflict with any contract, agreement, arrangement or understanding to which Buyer and/or any of its Affiliates is a party, including this Agreement and any other contract, agreement, arrangement or understanding with Supplier and/or its Affiliates, (ii) infringe on any trademark, service xxxx, copyright, patent, trade secret or other intellectual property rights of any Person, or (iii) violate any Applicable Law. Buyer shall indemnify and hold Supplier and its Affiliates harmless (including with respect to reasonable attorneys’ fees and disbursements) from any breach of this representation and warranty.

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