Manufacturing Standards and Procedures Sample Clauses

Manufacturing Standards and Procedures. Unless otherwise agreed in writing by Codexis, all Products supplied hereunder and the manufacture thereof shall comply with appropriate quality standards depending on the intended market, including but not limited to cGMP. Arch shall adopt and maintain quality assurance procedures and perform quality control tests designed to ensure that all Products manufactured under this Agreement conform to and are manufactured in accordance with this Agreement, including any other requirements of a Codexis Customer which requirements shall be set forth in the relevant Purchase Order or otherwise set forth in writing by Codexis. Without limiting the foregoing, Arch agrees as follows: (a) Arch shall be responsible for creating and retaining all records relating to the manufacturing, analysis and distribution, testing and release of materials, production and quality control (including in-process controls) as actual manufacturer, including Product Quality Review, generally in accordance with cGMP and shall provide copies to Codexis upon its reasonable written request. (b) Arch shall retain reference samples from each Batch of Products for the period of time required by Applicable Law and cGMP regulations. Arch shall retain samples sufficient to conduct at least three re-examinations. Arch shall, upon written request, make reference samples available for inspection, testing, analysis and examination by Codexis and/or any relevant Government Authority, solely for the purposes of determining compliance with Applicable Law or the requirements under this Agreement. (c) The equipment and facilities used for manufacturing must be qualified by Arch. The results must be documented in writing. The processes for manufacturing of Product must be validated by Arch in accordance with the approved validation protocol. The validation should be performed on the three consecutive Batches which should each be included in formal stability studies. The stability studies should be performed in accordance to the valid ICH guidelines for the Product. (d) Arch shall ensure that the Products have been manufactured in compliance with all requirements under this Agreement and shall release only Batches, which have been manufactured and analyzed by Arch according to the Product Specifications.
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Manufacturing Standards and Procedures. Unless otherwise agreed to in writing by Codexis, on an Enzyme-by-Enzyme basis, all Enzymes supplied hereunder and the manufacture thereof shall comply with appropriate quality standards depending on the intended market. Upon the Effective Date, the Parties will enter into a separate quality agreement (“Quality Agreement”), which will address, among other things, mechanisms to ensure compliance, additional audit rights, and maintenance of records. In the event of a conflict specific to an issue of quality between the provisions of the Quality Agreement, the applicable Work Order, the applicable Purchase Order, and any provisions of this Agreement, the following order of precedence shall apply: the applicable Purchase Order shall govern, followed by the applicable Work Order, followed by the provisions of the Quality Agreement, followed by the provisions of this Agreement. The Quality Agreement may be amended from time to time by written mutual consent of the Parties in light of changing regulatory requirements or other circumstances. Company shall adopt and maintain quality assurance procedures and perform quality control tests designed to ensure that all Enzymes manufactured under this Agreement conform to and are manufactured in accordance with this Agreement and the Quality Agreement.
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Manufacturing Standards and Procedures. As soon as practicable after the Effective Date, the Parties will enter into a separate quality agreement (“Quality Agreement”) which will address, among other things, mechanisms to ensure compliance, additional audit rights, and maintenance of records. In the event of a conflict specific to an issue of quality between the provisions of the Quality Agreement and any provisions of this Agreement, the provisions of the Quality Agreement shall govern; otherwise, the provisions of this Agreement shall govern. The Quality Agreement may be amended from time to time by written mutual consent of the Parties in the light of changing regulatory requirements or other circumstances. Arch shall adopt and maintain quality assurance procedures and perform quality control tests designed to ensure that all Product manufactured under this Agreement conforms to and is manufactured in accordance with the Quality Agreement.
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Manufacturing Standards and Procedures. PMII shall adopt and maintain quality assurance procedures and perform periodic quality control tests adequate to ensure that Reloads manufactured under this Agreement conform to Device Regulation (collectively the “QA Procedures”). At the request of ISRG, PMII shall promptly submit to ISRG in writing a description of its QA Procedures and will in good faith consider for incorporation any reasonable suggestions ISRG might make to the QA Procedures. PMII represents and warrants that the manufacturing facilities in which the Reloads are manufactured are (and during the term of this Agreement will be) registered with the FDA.
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Related to Manufacturing Standards and Procedures

  • Manufacturing Standards All forest products except poles, produced and sold under this contract will be manufactured to maximize the amount of logs meeting preferred log lengths and to achieve the average log length listed. 97318 3 WS "WS" indicates that west side scaling rules apply. Minimum trim is 8 inches per scaling segment for west side scaling rules. "ES" indicates that east side scaling rules apply. Minimum trim is 4 inches per scaling segment for east side scaling rules. Poles produced under this contract will be manufactured to ANSI specifications (American National Standard Specifications and Dimensions for Wood Poles), in force at the time of signing this contract. a. Sweep will be limited to within the bole of the log as measured using a tape stretched between the centers of each end of the log. b. Logs approved by the state for peelers shall be chuckable with no more than a 2 inch diameter area of rot within a 5 inch diameter circle located at the center of either end of the log. c. Limbs and knots shall be cut flush, with no more than 15 percent of a log having limbs or knots over 2 inches in diameter extending more than 2 inches above the surface of the log.

  • Quality Standards Each Party agrees that the nature and quality of its products and services supplied in connection with the other Party's Marks will conform to quality standards set by the other Party. Each Party agrees to supply the other Party, upon request, with a reasonable number of samples of any Materials publicly disseminated by such Party which utilize the other Party's Marks. Each Party will comply with all applicable laws, regulations, and customs and obtain any required government approvals pertaining to use of the other Party's marks.

  • Technical Standards The Generation System shall be installed and operated by the Interconnection Customer consistent with the requirements of this Agreement; the Technical Requirements; the applicable requirements located in the National Electrical Code (NEC); the applicable standards published by the American National Standards Institute (ANSI) and the Institute of Electrical and Electronic Engineers (IEEE); and local building and other applicable ordinances in effect at the time of the installation of the Generation System.

  • Development Standards For any structure built on the Property following the Effective Date, it shall comply with the requirements contained in Exhibit B, “Building Materials,” attached hereto and incorporated herein. The Parties agree and acknowledge that the provisions of this Paragraph shall apply to any structure constructed subsequent to the execution of this Agreement. Nothing in this Agreement shall be deemed to modify or otherwise amend any zoning regulation duly adopted by the Town, previously or in the future.

  • Safety Standards Performance of the Contract for all commodities or contractual services must comply with requirements of the Occupational Safety and Health Act and other applicable State of Florida and federal requirements.

  • OMB Standards Unless specified otherwise within this agreement, the Subrecipient shall procure all materials, property, or services in accordance with the requirements of 24 CFR 84.40−48.

  • Contract Work Hours and Safety Standards Act The following clauses apply to any Federal-aid construction contract in an amount in excess of $100,000 and subject to the overtime provisions of the Contract Work Hours and Safety Standards Act. These clauses shall be inserted in addition to the clauses required by 29 CFR 5.5(a) or 29 CFR 4.6. As used in this paragraph, the terms laborers and mechanics include watchmen and guards.

  • 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.

  • Specifications and Standards a) All articles supplied shall strictly conform to the specifications, trademark laid down in the bidding document and wherever articles have been required according to ISI/ ISO/ other applicable specifications/ certifications/ standards, those articles should conform strictly to those specifications/ certifications/ standards. The supply shall be of best quality and description. The decision of the competent authority/ purchase committee whether the articles supplied conforms to the specifications shall be final and binding on the supplier/ selected bidder.

  • Applicable Standards The requirements and guidelines of NERC, the Applicable Regional Entity, and the Control Area in which the Customer Facility is electrically located; the PJM Manuals; and Applicable Technical Requirements and Standards.

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