Product Conformity Sample Clauses

Product Conformity. Within fifteen (15) business days from the date of shipment of Product to Celator or the receipt of the Released Executed Batch Record, as defined in Product Master Plan, whichever is later, Celator shall determine whether such Product and related documentation conforms to the Product Specifications, Master Batch Record, and Baxter SOPs (collectively, the “Product Requirements”); provided, however, that Celator shall have the right to revoke acceptance if, within thirty (30) business days of receipt of the Batch, Celator discovers a latent defect or adulteration not reasonably discoverable at time of delivery. 7.1.1 If (a) any Product conforms to the Product Requirements, or (b) Celator fails to notify Baxter in accordance with the procedures set forth in Section 7.1 that any Product does not conform to the Product Requirements, then Celator shall be deemed to have accepted the Product and waived its right to revoke acceptance. 7.1.2 If Celator believes Product does not conform to the Product Requirements, it shall notify Baxter by telephone including a detailed explanation of the non-conformity and shall confirm such notice in writing via international courier service. Upon receipt of such notice, Baxter will investigate such alleged non-conformity, and (i) if Baxter agrees such Product is non-conforming, Baxter and Celator will mutually determine a corrective action plan within sixty (60) calendar days after receipt of Celator’s written notice of non-conformity, or such additional time as is reasonably required if such investigation or plan requires data from sources other than Celator or Baxter, or (ii) if Baxter disagrees with Celator’s determination that the shipment of Product is non-conforming, Baxter shall so notify Celator by telephone within a ten (10) calendar day period and confirm such notice in writing by overnight delivery to Celator. 7.1.3 If the Parties dispute whether Product is conforming or non-conforming to the Product Requirements, the Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof of non-conformity, shall be binding upon the Parties. Notwithstanding the foregoing, Celator may not release a Batch of Product that Baxter has reasonably rejected in good faith. The costs of such laboratory or consultant are to be borne by the Party whose determination was incorrect.

Product Conformity. 1. If the contractor supplies products which are subject to statutory and other legal requirements with regard to their placing on the market and their further marketing in the European Economic Area or corresponding requirements in other countries of use notified by us, then he shall ensure that the products comply with these requirements at the time of the transfer of risk. He shall immediately and upon request provide us with all evidence of conformity. 2. If the contractor delivers products whose product components are in a list of declarable substances currently valid at the time of the order, or which are subject to material restrictions and/or material information obligations due to laws (e.g. REACH, RoHS, California Proposition 65), the contractor shall assure us upon request that the required limit values and documentation obligations are complied with. This shall be carried out free of charge by the contractor. Before accepting the order, the contractor shall expressly inform us that the delivery item is subject to the special requirements and shall otherwise expressly recognise all manufacturer obligations (in particular labelling obligation, take-back obligation, etc.) arising from the relevant laws and regulatiions with regard to us. 3. The contractor expressly assures that the delivered goods comply with all requirements of the Act on the Placing on the Market, the taking back and the environmentally-sound disposal of electrical and electronic equipment (ElektroG based on the WEEE Directive 2012/19/EU) as amended from time to time, insofar as the goods fall within the scope of these laws, regulations and directives. 4. The contractor has instituted appropriate measures to ensure that his supplies and services comply with the requirements arising from Regulation (EU) 2017/821 dated 17 May 2017 establishing supply chain due diligence obligations and the Act implementing it dated 6 May 2020 and Section 1502 of the Xxxx-Xxxxx Act (as applicable), as amended from time to time, with respect to the use of so-called conflict minerals (e.g. tantalum, tungsten, tin or gold).

Product Conformity. Angiotech, in consultation with the JSC, shall determine the Clinical Development Product and Cell Therapy Product specifications and testing methods (“Product Specifications”) for the Clinical Development Products and Cell Therapy Products to be supplied by Athersys hereunder, and such specifications and testing methods shall be consistent with industry standards and applicable regulatory requirements. When Regulatory Approval is obtained in any country of the Territory, the Product Specifications shall be those specifications and testing methods which have been approved by the regulatory authority in that country. The Product Specifications may be amended from time to time by written mutual agreement of the Parties. Athersys shall, and shall ensure that any Third-Party manufacturer shall, manufacture the Clinical Development Products and Cell Therapy Products in conformance with the Product Specifications and in compliance with the requirements set forth in Section 9.3.

Product Conformity. In the event of test results which show a lack of Product conformity to quality or specifications provided and mutually agreed to, KEO will repair or replace the Product within a reasonable time. Failure to repair or replace non-conforming products, as defined in the purchase orders and agreed upon specifications, within eight (8) weeks shall be considered a failure to supply.

Product Conformity. Seller will manufacture Products in accordance with the then-current (a) Specifications, (b) applicable regulations relating to the current Good Manufacturing Practices (as defined by the Food, Drug and Cosmetic Act, as amended) and similar protocols (“cGMP”), (c) the United States Food and Drug Administration (“FDA”) quality system regulations (“QSR”), including master device and lot history records, ISO 13485 requirements, ISO14971 requirements, MDD requirements and CMDCAS requirements, and (d) other pertinent rules and regulations of FDA and similar regulatory bodies in other applicable jurisdictions set forth in the Specifications, as amended. In the event that Seller is required or deems it desirable to obtain ISO Quality System Certification, Seller shall promptly notify Buyer in writing of Seller’s selection (or change in registrar) for obtaining ISO Quality System Certification. Seller shall maintain a current Declaration of Conformity status with EU Notified Bodies per MDD requirements when Buyer is distributing in European markets. During the term of this Agreement, Seller will maintain or cause to be maintained the Product manufacturing facility’s registration as a certified medical device manufacturing facility and will maintain such facility registration with all applicable regulatory bodies or cause such facility to be maintained such that the facility would pass an audit for compliance with cGMP and QSR. Seller shall maintain ongoing quality assurance and testing policies sufficient to satisfy its obligations under this Agreement, and Seller's standard quality assurance policies. Any non-conformance in Product, material or process which Seller wishes to use “as is” or rework will require prior written approval from Buyer. Seller will assume full responsibility and its costs for any product development activities necessary to remedy any non-conformance in Products arising exclusively from defects in Product design, manufacture or materials, or from deviation from quality standards (but not in any way from Product claims, which are the sole responsibility of Buyer), which non-conformance is not approved by Buyer in accordance with the requirements of the preceding sentence. Seller shall be responsible for obtaining and maintaining any required regulatory filings and registrations set forth in the Specifications, as amended, including ISO registration (“CE Mxxx”) and 510(k) filings with the FDA (collectively, the “Regulatory Filings”) for the P...

Product Conformity. In selling to Distributor, Manufacturer agrees to deliver Products conforming to Manufacturer’s Product specifications as set forth in Appendix B attached hereto.

Product Conformity. The Company shall be the legal manufacturer of the Products and FDA and CE Registration of the Products shall be in the name of the Company. The Customer is solely the distributor of the Products purchased from the Company under the Customer’s name (“KEYSTONE”). Accordingly, the Company agrees to obtain FDA clearance and CE Registration of Products charging the costs detailed in Annex II. Company guarantees that it will maintain and/or obtain again, under the same conditions as when signing this Agreement, CE mark and/or FDA Clearance of Products bought by the Customer in accordance with this Agreement based on the current applicable regulations (e.g. EN ISO 13485, MDR...) during the term of the Agreement. The Company agrees to provide documentation of FDA clearance and CE Declaration of Conformity to the Customer so that the Customer can comply, or cause compliance with, reqistration requirements as an initial importer. As between CE registration and FDA clearance, the Company shall prioritize obtaining FDA clearance so that FDA clearance may be obtained as soon as reasonably possible. The Company and the Customer will collaborate as may be mutually agreed in other registrations of Products as requested by the Customer from time to time in the future under any registration registration requirements in compliance with Health Canada, and with other legally required registrations in Great Britain, Switzerland, Asia, Mexico, and Latin America. The Company shall otherwise cause the Products to comply with all legal requirements applicable to the Products in the United States initially and in each other jurisdiction in the Territory if and when the Territory is expanded as described in the immediately preceding paragraph (collectively, “Applicable Law”). The Customer has to register as initial importer of the Products in the United States and the Customer must ensure that the initial importer of products is registered as required in each other jurisdiction in the Territory if and when the Territory is expanded.

Product Conformity. Shipments of Components to SJM will be accompanied by a Certificate of Conformance or Certificate of Analysis. SJM will notify Supplier after receipt of the Components if any of the Components fail to meet Specifications. Supplier may, at its option and at its expense, re-inspect the Components at SJM's premises or perform the re-inspection at its own facilities. In the event of reported Components damage or failure of the Components to meet the Specifications, both parties will support each other in conducting failure investigations. To this end, Supplier agrees to provide documentation to SJM relevant to the manufacture of the Components. 1.4

Product Conformity. The products sold on the Website meet applicable requirements respecting the health and safety of persons, fair trading and consumer protection at the time they are placed on the market.

Product Conformity. The Company shall be the legal manufacturer of the New Territory’s Products all Regulatory Registration shall be in the name of the Company. The Customer and the New Territory Subsidiary is solely the distributor of the New Territory’s Products purchased from the Company under the Customer’s name (“Keystone”) or under the New Territory Subsidiary’s name (“Osteon Medical”). If the Customer decides to market products out of the territories where we have Products legalized, it will be the customer himself who will inform the Company to discuss how the payment of the costs corresponding to the registration and legalization will be managed. In no case will Terrats Medical be held responsible without prior discussion with the Customer.