Common use of Quality Control and Assurance Clause in Contracts

Quality Control and Assurance. (a) Patheon shall manufacture, package, test and ship the Products in accordance with (i) the current good manufacturing practices as described in Division 2 of Part C of the Food and Drug Regulations (Canada) and Parts 210 and 211 of Title 21 of the United States Code of Federal Regulations, together with the latest Health Canada and FDA guidance documents pertaining to manufacturing and quality control practices all as updated, amended and revised from time to time (collectively “GMPs”), and (ii) the Specifications. Patheon’s responsibilities and obligations described in the foregoing sentence are hereinafter referred to as the “Patheon Manufacturing Requirements”. (b) Patheon shall perform the quality control and quality assurance testing specified in the Quality Agreement. (c) If the Products as manufactured by Patheon do not satisfy Patheon’s quality control and quality assurance testing due to Patheon’s failure to produce the Products in accordance with the Patheon Manufacturing Requirements, Patheon shall, at its sole cost and expense, manufacture additional Products to replace such defective Products. In such circumstances, Client shall have no obligation to purchase or pay for any rejected Products. (d) Notwithstanding any provisions of this Agreement to the contrary, the parties agree that Patheon shall not be liable or have any responsibility for any deficiencies in, or other liabilities associated with: (i) the formulae and procedures specified by Client; (ii) the safety (except to the extent due to the fault of Patheon as determined in accordance with the provisions of this Agreement), efficacy or marketability of the Products; (iii) distribution risk; (iv) Components, provided that any such deficiency was not reasonably discoverable using the test methods detailed in the Specifications and applying such test methods in accordance with GMP; or (v) services provided by third parties in connection with the packaging of the bulk Product. (e) Each time Patheon ships Products to Client, it shall provide Client with a certificate of analysis that sets out the actual test results for each lot of Products and which certifies that the Products shipped to Client have been evaluated by Patheon’s Quality Control/Quality Assurance department and that the Products comply with the Patheon Manufacturing Requirements. * Redacted text has been omitted and filed separtely pursuant to a request for confidential treatment. Patheon shall not under any circumstances ship Non-Conforming Products (as defined in Section 2.6(a)) to Client.

Quality Control and Assurance. (a) Patheon AAI shall manufacture, package, test manufacture and ship supply the Products in accordance with (i) the Specifications; (ii) the approved NDA; and (iii) the current good Good Manufacturing Practices for manufacturing practices as described in Division 2 of Part C of finished products specified by the Food and Drug Regulations FDA (Canada) and Parts 210 and 211 of Title 21 of the United States Code of Federal Regulationscollectively, together with the latest Health Canada and FDA guidance documents pertaining to manufacturing and quality control practices all as updated, amended and revised from time to time (collectively “GMPs”), and (ii) the Specifications. PatheonAAI’s responsibilities and obligations described with respect to the manufacture of Products as set forth in the foregoing sentence this Section 2.4(a) are hereinafter referred to as the “Patheon AAI Manufacturing Requirements.”. (b) Patheon AAI shall perform the such quality control and quality assurance testing specified in as is reasonably required by the Quality AgreementControl Agreement to ensure that the Products comply with all of the AAI Manufacturing Requirements as of the date of shipment to Medicis. (c) If the Products as manufactured by Patheon AAI do not satisfy Patheon’s its quality control and quality assurance testing obligations due to PatheonAAI’s failure to produce the Products in accordance with the Patheon Manufacturing RequirementsQuality Control Agreement, Patheon AAI shall, at its sole cost and expense, manufacture additional Products to replace such defective Products. In such circumstances, Client Medicis shall have no obligation to purchase or pay for any rejected ProductsProducts that are defective, unless and only to the extent that such Product is used by Medicis for another purpose, in which event Medicis shall only be required to pay for that portion of the rejected Products which it actually so uses. (d) Notwithstanding any provisions of this Agreement to the contrary, the parties The Parties hereto agree that Patheon except in the circumstances where AAI has failed to comply with the AAI Manufacturing Requirements, AAI shall not be liable or have any responsibility for any deficiencies in, or other liabilities associated with: (i) with respect to the formulae Labeling and procedures specified by Client; (ii) Medicis, sales and marketing of the safety (except to the extent due to the fault of Patheon as determined in accordance with the provisions of this Agreement), efficacy Products or marketability distribution of the Products; (iii) distribution risk; (iv) Components, provided that any such deficiency was not reasonably discoverable using the test methods detailed in the Specifications and applying such test methods in accordance with GMP; or (v) services provided by third parties in connection with the packaging of the bulk Product. (e) Each time Patheon ships Products to Client, it AAI shall provide Client Medicis with a certificate of conformance, a certificate of analysis, and copies of the batch record, any deviation and investigation reports, and Labeling prior to shipping Products to Medicis. The certificate of analysis that sets will set out the actual test results for each lot of Products Products, and which certifies will certify that the Products shipped to Client Medicis have been evaluated by PatheonAAI’s Quality Control/Quality Assurance department and that the Products comply with the Patheon Manufacturing RequirementsSpecifications. * Redacted text has been omitted and filed separtely pursuant Medicis shall issue a formal QA release prior to a request for confidential treatment. Patheon shall not under any circumstances ship Non-Conforming Products (as defined in Section 2.6(a)) to Clientthe shipment of product by AAI.

Quality Control and Assurance. (a) Patheon shall manufacture, package, test and ship the Products in accordance with (i) all applicable laws and regulations, including but not limited to, the U.S. Federal Food, Drug and Cosmetic Act and the regulations promulgated thereunder (such as current good manufacturing practices Good Manufacturing Practices ("GMPs"), as described in Division 2 of Part C of the Food and Drug Regulations (Canada) and Parts 210 and 211 of Title 21 of the United States Code of Federal Regulations, together with the latest Health Canada and FDA guidance documents pertaining to manufacturing and quality control practices all as updated, amended and revised in effect from time to time (collectively “GMPs”)time, and (ii) the Specifications. Patheon’s 's responsibilities and obligations described in the foregoing sentence are hereinafter referred to as the “"Patheon Manufacturing Requirements”". (b) Patheon shall perform the such quality control and quality assurance testing specified in as is required to ensure that the Quality AgreementProducts comply with all of the Patheon Manufacturing Requirements. (c) If the Products as manufactured by Patheon do not satisfy Patheon’s 's quality control and quality assurance testing due to Patheon’s 's failure to produce the Products in accordance with the Patheon Manufacturing Requirements, Patheon shall, at its sole cost and expense, manufacture additional Products to replace such defective Products. In such circumstances, Client shall have no obligation to purchase or pay for any rejected Products. (d) Notwithstanding any provisions of this Agreement to the contrary, the The parties hereto agree that Patheon shall not be liable or have any responsibility for any deficiencies in, or other liabilities associated with: (i) , the formulae and procedures specified by Client; (ii) , the safety (except to the extent due to the fault of Patheon as determined in accordance with the provisions of this Agreement)safety, efficacy or marketability of the Products; (iii) Products or any distribution risk; (iv) Components, provided that any such deficiency was not reasonably discoverable using the test methods detailed in the Specifications and applying such test methods in accordance with GMP; or (v) services provided by third parties in connection with the packaging of the bulk Product. (e) Each time Patheon ships Products to Client, it shall provide Client with a certificate of analysis that sets out the actual test results for each lot of Products and which certifies that the Products shipped to Client have been evaluated by Patheon’s 's Quality Control/Quality Assurance department and that the Products comply with the Patheon Manufacturing Requirements. * Redacted text has been omitted and filed separtely pursuant to a request for confidential treatment. Patheon shall not under any circumstances ship Non-Conforming Products (as defined in Section 2.6(a)) to Client.

Quality Control and Assurance. (a) Patheon BIOLITEC shall manufacture, package, test manufacture and ship supply the Products in an ISO certified facility in accordance with (i) the Product Specifications, (ii) the Packaging Specifications, (iii) current good manufacturing practices as described in Division 2 of Part C of the Food and Drug Regulations specified by any applicable Competent Authority (Canadacollectively, "cGMPs") and Parts 210 (iv) all other Applicable Laws. Furthermore, BIOLITEC warrants that all Products provided hereunder shall be free from defect in material and 211 workmanship at the time of Title 21 of the United States Code of Federal Regulations, together with the latest Health Canada and FDA guidance documents pertaining shipment to manufacturing and quality control practices all as updated, amended and revised from time to time (collectively “GMPs”), and (ii) the Specifications. Patheon’s responsibilities and obligations described in the foregoing sentence are hereinafter referred to as the “Patheon Manufacturing Requirements”AngioDynamics. (b) Patheon BIOLITEC shall be responsible for quality control of the Products and shall perform the such quality control and quality assurance testing specified in as is necessary or appropriate to ensure that the Quality AgreementProducts comply with the Manufacturing Requirements. (c) If the Products as manufactured by Patheon do not satisfy Patheon’s quality control and quality assurance testing due to Patheon’s failure to produce the Products in accordance with the Patheon Manufacturing Requirements, Patheon shall, at its sole cost and expense, manufacture additional Products to replace such defective Products. In such circumstances, Client shall have no obligation to purchase or pay for any rejected Products. (d) Notwithstanding any provisions of this Agreement to the contrary, the parties agree that Patheon shall not be liable or have any responsibility for any deficiencies in, or other liabilities associated with: (i) the formulae and procedures specified by Client; (ii) the safety (except to the extent due to the fault of Patheon as determined in accordance with the provisions of this Agreement), efficacy or marketability of the Products; (iii) distribution risk; (iv) Components, provided that any such deficiency was not reasonably discoverable using the test methods detailed in the Specifications and applying such test methods in accordance with GMP; or (v) services provided by third parties in connection with the packaging of the bulk Product. (e) Each time Patheon BIOLITEC ships Products to ClientAngioDynamics, it shall provide Client AngioDynamics with a certificate of analysis compliance that sets out the actual test results for each lot of Products Products, and which that certifies that the Products shipped to Client AngioDynamics have been evaluated by Patheon’s BIOLITEC's Quality Control/Quality Assurance department and that the Products comply with the Patheon Manufacturing Requirements. * Redacted text has been omitted . (d) BIOLITEC shall permit AngioDynamics or its designated representative to perform such audits and filed separtely pursuant inspections as may be requested by AngioDynamics of the facilities, procedures and records that are relevant to a request BIOLITEC's manufacturing of Products, and to the extent reasonably obtainable by BIOLITEC, of facilities, procedures and records that are relevant to such audits or inspections of unaffiliated parties with responsibility for confidential treatment. Patheon testing, analyzing, labeling or packaging the Product. (e) BIOLITEC shall notify AngioDynamics of any proposed changes in critical materials or processes which affect the form, fit or function of Products at least ninety (90) days prior to such actions and shall not under make any circumstances ship Non-Conforming Products such change without the prior written consent of AngioDynamics, which consent shall not be unreasonably withheld, conditioned or delayed. (as defined f) BIOLITEC shall promptly inform AngioDynamics of the results of all visits and inspections, relating to the Product, by Competent Authorities, including, without limitation, providing AngioDynamics with copies of all warning letters, 483s and other correspondence with the Competent Authority. (g) In the event of any customer complaints regarding the Product, BIOLITEC agrees to cooperate and assist AngioDynamics in Section 2.6(a)) to Clientinvestigating such complaints and providing an appropriate response.