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 M▇▇▇”) and 510(k) filings with the FDA (collectively, the “Regulatory Filings”) for the Products under Seller’s notified body or through other applicable Regulatory Authorities (defined below and set forth in the Specifications, as amended); provided, that Buyer will have the right to review any Regulatory Filings and provide comments on such filings (which Seller will consider in good faith) before they are submitted by Seller; and further, provided, that Buyer will at all times upon notice to Seller have the right to make any Regulatory Filings with Regulatory Authorities outside of the United States in Buyer’s name and Seller will provide Buyer with access to all documents necessary or appropriate for Buyer to make such Regulatory Filings and with authorization to use such documents and the information contained therein to make Regulatory Filings as the distributor of Products. Upon termination or expiration of this Agreement, Buyer may purchase from Seller physical and legal ownership of all Regulatory Filings for the Product, including all documents and communications to and from the pertinent Regulatory Authorities. Products will bear Seller’s regulatory registration m▇▇▇(s), including Seller’s CE M▇▇▇. As used in this Agreement, “Regulatory Authority” means any national supra-national, foreign, regional, state or local regulatory agency, department, bureau, notified body, commission, council or other governmental entity, including FDA, as set forth in the Specifications, as amended.
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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 M▇▇▇▇”) and 510(k) filings with the FDA (collectively, the “Regulatory Filings”) for the Products under Seller’s notified body or through other applicable Regulatory Authorities (defined below and set forth in the Specifications, as amended); provided, that Buyer will have the right to review any Regulatory Filings and provide comments on such filings (which Seller will consider in good faith) before they are submitted by Seller; and further, provided, that Buyer will at all times upon notice to Seller have the right to make any Regulatory Filings with Regulatory Authorities outside of the United States in Buyer’s name and Seller will provide Buyer with access to all documents necessary or appropriate for Buyer to make such Regulatory Filings and with authorization to use such documents and the information contained therein to make Regulatory Filings as the distributor of Products. Upon termination or expiration of this Agreement, Buyer may purchase from Seller physical and legal ownership of all Regulatory Filings for the Product, including all documents and communications to and from the pertinent Regulatory Authorities. Products will bear Seller’s regulatory registration m▇▇▇(s▇(s), including Seller’s CE M▇▇▇▇. As used in this Agreement, “Regulatory Authority” means any national supra-national, foreign, regional, state or local regulatory agency, department, bureau, notified body, commission, council or other governmental entity, including FDA, as set forth in the Specifications, as amended.
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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 M▇▇▇”) and 510(k) filings with the FDA (collectively, the “Regulatory Filings”) for the Products under Seller’s notified body or through other applicable Regulatory Authorities (defined below and set forth in the Specifications, as amended); provided, that Buyer will have the right to review any Regulatory Filings and provide comments on such filings (which Seller will consider in good faith) before they are submitted by Seller; and further, provided, that Buyer will at all times upon notice to Seller have the right to make any Regulatory Filings with Regulatory Authorities outside of the United States in Buyer’s name and Seller will provide Buyer with access to all documents necessary or appropriate for Buyer to make such Regulatory Filings and with authorization to use such documents and the information contained therein to make Regulatory Filings as the distributor of Products. Upon termination or expiration of this Agreement, Buyer may purchase from Seller physical and legal ownership of all Regulatory Filings for the Product, including all documents and communications to and from the pertinent Regulatory Authorities. Products will bear Seller’s regulatory registration m▇▇▇(s), including Seller’s CE M▇▇▇. As used in this Agreement, “Regulatory Authority” means any national supra-national, foreign, regional, state or local regulatory agency, department, bureau, notified body, commission, council or other governmental entity, including FDA, as set forth in the Specifications, as amended.. BUYER: __________ Page 7 of 24 SELLER: __________
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