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. 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.
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. Within [***] ([***]) days from the date of receipt by AMYLIN of samples of Product or [***] ([***]) calendar days from the date of receipt by AMYLIN of the Released Executed Batch Record to AMYLIN, whichever is later, AMYLIN shall determine whether such Batch conforms to the Product Requirements.
Product Conformity. With respect to each Batch, no later than thirty (30) days from Nephron’s delivery of the COA and Released Executed Batch Record (provided by RevitaLid) for such Batch, RevitaLid shall notify Nephron in writing if the Batch fails to meet the Product Requirements.
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. Within twenty-five (25) business days from the date of shipment of Product and/or Released Executed Batch Record, as defined in Product Master Plan, to Client, whichever is later, Client shall determine whether Product conforms to Product Specifications, Master Batch Record, and Baxter SOPs (the “Product Requirements”), provided, however, that Client shall have the right to revoke acceptance if, within one hundred and twenty (120) days of receipt of the Batch, Client discovers a defect not reasonably discoverable at time of delivery. Baxter will not ship a Product that Baxter has rejected.
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.
