Common use of Quality System Requirements Clause in Contracts

Quality System Requirements. 7.1. Manufacturer shall obtain and maintain all registrations and approvals necessary to manufacture Customer’s Product. Manufacturer must remain compliant with the requirements set forth in 21 U.S.C. § 360J (f), 21 C.F.R. § 820, all related guidance issued by the FDA, ISO 13488 and/or ISO 13485 (collectively, “Good Manufacturing Practices”). Manufacturer’s performance of this Agreement shall be in compliance with these Good Manufacturing Practices. 7.2. Manufacturer agrees to permit Customer or its authorized representative, and government officials as required by law, to conduct inspections and test audits of Manufacturer’s facilities, operations, and procedures, at appropriate and reasonable time intervals, to verify that the quality and performance of the Product produced by Manufacturer are in compliance with the Company’s Product Specifications. The Company may also inspect the facilities of Manufacturer at any time during business hours to ensure compliance with Good Manufacturing Practices. Manufacturer shall cooperate with any inspection performed under this section. 7.3. Manufacturer agrees to make appropriate Manufacturer personnel available for audits at either Customer’s or Manufacturer’s offices. All reasonable expenses related to the conduct of inspection and test audits of the Product and/or Quality System (as defined below in Section 7.6) by Customer or, if Customer so chooses, a qualified third party, that are directly and specifically related to Customer’s Product shall be borne by Customer. Such audits and inspections must take place during normal business hours and with reasonable notice. 7.4. If the facilities or processes of Manufacturer are inspected or audited by any regulatory agency such as but not limited to the FDA, OHSA, EPA, or ISO Registrar, Manufacturer will immediately inform Customer of that fact and of all findings of such agency that relate to or affect the Product or Device Master Record, which includes all information necessary to produce the Product. 7.5. Manufacturer shall maintain a complete and current Device Master Record for Customer’s Product. Copies of the Device Master Record shall be made available to Customer at Customer’s request. Customer shall have the right from time to time to request that changes be made to the Device Master Record. Changes to the Device Master Record are to be communicated formally by the Customer’s change order and will be subject to Manufacturer’s acceptance, which acceptance shall not be unreasonably withheld. The cost of the changes, and for implementing such changes, will be negotiated in good faith between the Customer and Manufacturer. Manufacturer shall have no obligation to implement these changes until agreement on changes and prices have been reached. 7.6. Manufacturer shall maintain a quality system in accordance with ISO 13488 and/or ISO 13485 certification and 21 CFR 820 Quality System Regulations compliance (“Quality System”). All activities performed on behalf of Customer shall be performed in accordance with these regulations and standards. Manufacturer shall conduct manufacturing activities consistent with Customer’s Manufacturing Quality Plan. Manufacturer shall maintain and retain Product quality related records, such as any records of system or instrument tests, for 5 years. [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. 7.7. Manufacturer shall allow Customer and government officials to perform audits of Manufacturer’s Quality System, Good Manufacturing Practices, facilities, records and all manufacturing documentation related to Customer’s Product. 7.8. Manufacturer shall maintain a list of original component suppliers that they have approved (“Approved Suppliers”). Manufacturer shall purchase materials to be used in Customer’s Product for sale only from Approved Suppliers. Approved Suppliers must have passed Manufacturer’s supplier evaluation process. If it has been determined by the Customer and Manufacturer that there is cause, Manufacturer shall allow Customer to perform on-site audits of its Approved Suppliers, as requested, at mutually agreed upon times. Manufacturer shall assist the Approved Suppliers in providing corrective action to remedy any deficiencies observed during the audit, and document such actions and outcomes to Customer. 7.9. Manufacturer shall obtain prior approval from Customer on all proposed changes including changes in approved suppliers, except for typographical errors, to the Product Specifications, Device Master Record, manufacturing procedures, or validated processes. Manufacturer agrees that all design change, approval, and revision control shall be consistent with Good Manufacturing Practices and the Medical Device Directive, as published by the European Parliament. 7.10. Manufacturer agrees to comply with all additional terms and conditions specified in attached Device Specific Schedule(s).

Quality System Requirements. 7.1. 7.1 Manufacturer shall obtain and maintain all registrations and approvals necessary to manufacture Customer’s Product. Manufacturer must remain compliant with the requirements set forth in 21 U.S.C. § 360J (f), 21 C.F.R. § 820, all related guidance issued by the FDA, ISO 13488 and/or ISO 13485 9001 and EN46001 (collectively, “Good Manufacturing Practices”). Manufacturer’s performance of this Agreement shall be in compliance with these Good Manufacturing Practices. 7.2. 7.2 Manufacturer agrees to permit Customer or its authorized representative, and government officials as required by law, to conduct inspections and test audits of Manufacturer’s facilities, operations, and procedures, at appropriate and reasonable time intervals, to verify that the quality and performance of the Product produced by Manufacturer are in compliance with the Company’s Product Specifications. The Company may also inspect the facilities of Manufacturer at any time during business hours to ensure compliance with Good Manufacturing Practices. Manufacturer shall cooperate with any inspection performed under this section. 7.3. 7.3 Manufacturer agrees to make appropriate Manufacturer personnel available for audits at either Customer’s or Manufacturer’s offices. All reasonable expenses related to the conduct of inspection and test audits of the Product and/or Quality System (as defined below in Section 7.6) by Customer or, if Customer so chooses, a qualified third party, that are directly and specifically related to Customer’s Product shall be borne by Customer. Such audits and inspections must take place during normal business hours and with reasonable notice. 7.4. 7.4 If the facilities or processes of Manufacturer are inspected or audited by any regulatory agency such as but not limited to the FDA, OHSA, EPA, or ISO Registrar, Manufacturer will immediately inform Customer of that fact and of all findings of such agency that relate to or affect the Product or Device Master Record, which includes all information necessary to produce the Product. 7.5. 7.5 Manufacturer shall maintain a complete and current Device Master Record for Customer’s Product. Copies of the Device Master Record shall be made available to Customer at Customer’s request. Customer shall have the right from time to time to request that changes be made to the Device Master Record. Changes to the Device Master Record are to be communicated formally by the Customer’s change order and will be subject to Manufacturer’s acceptance, which acceptance shall not be unreasonably withheld. The cost of the changes, and for implementing such changes, will be negotiated in good faith between the Customer and Manufacturer. Manufacturer shall have no obligation to implement these changes until agreement on changes and prices have been reached. 7.6. 7.6 Manufacturer shall maintain a quality system in accordance with ISO 13488 and/or ISO 13485 90001, EN46001 certification and 21 CFR 820 Quality System Regulations compliance (“Quality System”). All activities performed on behalf of Customer shall be performed in accordance with these regulations and standards. Manufacturer shall conduct manufacturing activities consistent with Customer’s Manufacturing Quality Plan. Manufacturer shall maintain and retain Product quality related records, such as any records of system or instrument tests, for 5 years. [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. 7.7. 7.7 Manufacturer shall allow Customer and government officials to perform audits of Manufacturer’s Quality System, Good Manufacturing Practices, facilities, records and all manufacturing documentation related to Customer’s Product. 7.8. 7.8 Manufacturer shall maintain a list of original component suppliers that they have approved (“Approved Suppliers”). Manufacturer shall purchase materials to be used in Customer’s Product for sale only from Approved Suppliers. Approved Suppliers must have passed Manufacturer’s supplier evaluation process. If it has been determined by the Customer and Manufacturer that there is cause, Manufacturer shall allow Customer to perform on-site audits of its Approved Suppliers, as requested, at mutually agreed upon times. Manufacturer shall assist the Approved Suppliers in providing corrective action to remedy any deficiencies observed during the audit, and document such actions and outcomes to Customer. 7.9. 7.9 Manufacturer shall obtain prior approval from Customer on all proposed changes including changes in approved suppliers, component materials, product labels, manufacturing and/or test procedures, except for typographical errors, to the Product Specifications, Device Master Record, manufacturing procedures, or validated processes. Manufacturer shall also obtain prior approval on all deviations and NCMR’s that affect product or component for, fit and/or function including discrepant materials that are dispositioned by the Manufacturer as ‘Use As Is’. Manufacturer agrees that all design change, approval, and revision control shall be consistent with Good Manufacturing Practices and the Medical Device Directive, as published by the European Parliament. 7.10. 7.10 Manufacturer agrees to comply with all additional terms and conditions specified in attached Device Specific Schedule(s).

Quality System Requirements. 7.1. 8.1 Manufacturer shall obtain and maintain all registrations and approvals necessary to manufacture Customer’s Product. Manufacturer must remain compliant with the requirements set forth in 21 U.S.C. § 360J (f), 21 C.F.R. § 820, all related guidance issued by the FDA, ISO 13488 and/or ISO 13485 (collectively, “Good Manufacturing Practices”). Manufacturer’s performance of this Agreement shall be in compliance with these Good Manufacturing Practices. 7.2. 8.2 Manufacturer agrees to permit Customer or its authorized representative, and government officials as required by law, to conduct inspections and test audits of Manufacturer’s facilities, operations, and procedures, at appropriate and reasonable time intervals, to verify that the quality and performance of the Product produced by Manufacturer are in compliance with the Company’s Product Specifications. The Company may also inspect the facilities of Manufacturer at any time during business hours to ensure compliance with Good Manufacturing Practices. Manufacturer shall cooperate with any inspection performed under this section. Manufacturer shall implement corrective and preventative actions in a timely manner to address nonconformances noted in audits by Customer, FDA, ISO Registrar or other regulatory authorities. 7.3. 8.3 Manufacturer agrees to make appropriate Manufacturer personnel available for audits at either Customer’s or Manufacturer’s offices. All reasonable expenses related to the conduct of inspection and test audits of the Product and/or Quality System (as defined below in Section 7.68.6) by Customer or, if Customer so chooses, a qualified third party, that are directly and specifically related to Customer’s Product shall be borne by Customer. Such audits and inspections must take place during normal business hours and with reasonable notice. 7.4. 8.4 If the facilities or processes of Manufacturer are inspected or audited by any regulatory agency such as but not limited to the FDA, OHSAOSHA, EPA, CE Notified Body, or ISO Registrar, Manufacturer will immediately inform Customer of that fact and of all findings of such agency that relate to or affect the Product or Device Master Record, which includes all information necessary to produce the Product. 7.5. 8.5 Manufacturer shall maintain a complete and current Device Master Record for Customer’s Product. Copies of the Device Master Record shall be made available to Customer at Customer’s request. Customer shall have the right from time to time to request that changes be made to the Device Master Record. Changes to the Device Master Record are to be communicated formally by the Customer’s change order and will be subject to Manufacturer’s acceptance, which acceptance shall not be unreasonably withheld. The cost of the changes, and for implementing such changes, will be negotiated in good faith between the Customer and Manufacturer. Manufacturer shall have no obligation to implement these changes until agreement on changes and prices have been reached. 7.6. 8.6 Manufacturer shall maintain a quality system in accordance with ISO 13488 and/or ISO 13485 certification and 21 CFR 820 Quality System Regulations compliance (“Quality System”). All activities performed on behalf of Customer shall be performed in accordance with these regulations and standards. Manufacturer shall conduct manufacturing activities consistent with Customer’s Manufacturing Quality Plan. Manufacturer shall maintain and retain Product quality related records, such as any records of system or instrument tests, for 5 years. [*] = Portions Manufacturer shall contact Customer and provide the option of this exhibit have been omitted pursuant transferring records older than 5 years to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the CommissionCustomer’s location. 7.7. 8.7 Manufacturer shall allow Customer and government officials to perform audits of Manufacturer’s Quality System, Good Manufacturing Practices, facilities, records and all manufacturing documentation related to Customer’s Product. 7.8. 8.8 Manufacturer shall maintain a list of original component components and service suppliers that they have approved (“Approved Suppliers”). Manufacturer shall purchase materials and services to be used in Customer’s Product for sale only from Approved Suppliers. Approved Suppliers must have passed Manufacturer’s supplier evaluation process. If it has been determined by the Customer [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. and Manufacturer that there is cause, Manufacturer shall allow Customer to perform on-site audits of its Approved Suppliers, as requested, at mutually agreed upon times. Manufacturer shall assist the Approved Suppliers in providing corrective action to remedy any deficiencies observed during the audit, and document such actions and outcomes to Customer. Notwithstanding the foregoing, Customer reserves the right to reject any Approved Supplier, and Manufacturer shall not purchase components from such rejected suppliers in the manufacture of Products. 7.9. 8.9 Manufacturer shall obtain prior written approval from Customer on all proposed changes including including, without limitation, changes in approved suppliers, except for typographical errorsApproved Suppliers, to the Product Specifications, Device Master Record, manufacturing procedures, or validated processes. Manufacturer agrees that all design change, approval, and revision control shall be consistent with Good Manufacturing Practices and the Medical Device Directive, as published by the European Parliament. For the avoidance of doubt, any transfer of Product manufacturing to a different facility will require validation and prior written approval from Customer. 7.10. 8.10 Manufacturer agrees to comply with all additional terms and conditions specified in attached Device Specific Schedule(s). 8.11 In the event that Customer desires to change (and such change is not requested by the FDA or another regulatory authority) the manufacturing process, the manufacturing equipment, the Device Master Record, the Product Specifications, the materials, the sources of materials or the methods of testing for any Product, or to add any Customer product to the Products listed on Exhibit A, Manufacturer shall accommodate such change or addition; provided, however, that Customer shall not have the right to require Manufacturer to make any such change or manufacture such product that would violate any applicable laws or regulations. In the event the parties fail to agree on the existence of a violation of any applicable laws or regulations, Customer shall make the final determination in its sole discretion. If Customer requests a change with respect to any Product (or the addition of a new Product) that is not the result of a requirement of the FDA or any other regulatory authority or a result of a failure of Manufacturer to comply with the terms of this Agreement, and such change would result in an increase in the cost of production of such Product, Manufacturer shall, within thirty (30) days of its receipt of such a request from Customer, notify Customer in writing of any good faith price adjustment (or, with respect to the addition of a new Product, the product pricing terms) and implementation costs relating to such request. Customer then shall determine in its sole discretion whether to (i) implement such change (or addition) and accept such increase in price (or, with respect to the addition of a new Product, the product pricing terms) or implementation costs or (ii) withdraw the proposed change. If any change requested by Customer would result in a decrease in the cost of one or more Products, Manufacturer shall, pursuant to the terms of Section 7.3, adjust its price to Customer with respect to such Products, and Customer shall pay only such decreased price. 8.12 Manufacturer will host a formal and documented Process FMEA as soon as possible after the Effective Date. This pFMEA event will focus on the processes within Manufacturer as well as consider the fabrication of components manufactured by other suppliers. Mitigation efforts will then be undertaken as necessary to ensure acceptable risk. 8.13 It is expected that Manufacturer and Customer shall communicate through their respective Master Control and Arena software. 8.14 Customer shall compensate Manufacturer for all costs and expenses incurred in connection with the initial sampling, validation and performance of capability studies for all molds, tools, assembly steps, packaging equipment, sterility validation and testing protocols for each Product. Compensation for subsequent such activities shall be as determined in advance by the parties. [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. 8.15 Manufacturer represents, warrants and covenants that it is not currently using, and will not in the future use, in any capacity, in connection with the performance of its duties or obligations hereunder, the services of any person debarred or subject to debarment under 21 U.S.C. § 335(a) or otherwise disqualified or suspended from performing services or otherwise subject to any restrictions or sanctions by the FDA or any other regulatory authority or professional body (a “Debarred Person”). Manufacturer shall immediately notify Customer in writing if any person or entity who is performing services on its behalf hereunder is or becomes a Debarred Person or if any action, claim, investigation, or other legal or administrative proceeding is pending or, to the best of Manufacturer’s knowledge, threatened, that would make any person performing services hereunder a Debarred Person or would preclude Manufacturer from performing its obligations under this Agreement. Manufacturer shall require all persons and entities providing services under this Agreement to make substantially the same warranty and covenant. 8.16 If the FDA or another regulatory authority (a) contacts Manufacturer with respect to the manufacture of the Products, (b) conducts, or gives notice of its intent to conduct, an inspection of the facilities of Manufacturer being used for the manufacture of the Products, or (c) takes, or gives notice of its intent to take, any other regulatory action alleging improper or inadequate practices with respect to any activity of Manufacturer, then Manufacturer shall notify Customer within three (3) business days of such contact or notice, or sooner if necessary to permit Customer to be present at, or otherwise participate in, any such inspection or regulatory action with respect to the Products, and shall supply Customer with all information pertinent thereto. Customer shall have the right to be present at and to participate in any such inspection or regulatory action with respect to the Products. Customer shall be provided with copies of all documentation issued by the FDA or any other regulatory authority in connection therewith and any proposed responses thereto. No such response shall include any false or misleading information with respect to the Products or Customer. 8.17 Customer shall be solely responsible for reporting all medical device and malfunction reports as defined in the US Code of Federal Regulations title 21 §803, relating to the Products. To the extent Manufacturer has or receives any information regarding any medical device and malfunction report that may be related to the use of the Product, Manufacturer shall immediately, and in no event later than two (2) business days of receipt by Manufacturer, provide Customer with all such information.