Common use of Health Care Products Manufacturing Clause in Contracts

Health Care Products Manufacturing. The manufacture of the Company’s products by or, to the knowledge of the Company, on behalf of the Company is being conducted in compliance in all material respects with all applicable Health Care Laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820, and, to the extent applicable, the respective counterparts thereof promulgated by other Health Regulatory Agencies. Except as disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the Company has not had any manufacturing site (whether Company-owned or, to the knowledge of the Company, that of a third party manufacturer for the Company’s products) subject to a Health Regulatory Agencies (including FDA) shutdown or import or export prohibition, nor received any FDA or other Health Regulatory Agency “warning letters,” or “untitled letters” alleging or asserting material noncompliance with any applicable Health Care Laws, requests to make material changes to the Company’s products, processes or operations, or similar correspondence or notice from the FDA or other Health Regulatory Agencies alleging or asserting material noncompliance with any applicable Health Care Laws, other than those that have been satisfactorily addressed and/or closed with the FDA or other Health Regulatory Agencies. To the Company’s knowledge, neither the FDA nor any other Health Regulatory Agencies is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s products by the Company or, to the knowledge of the Company, on behalf of the Company Company, is being conducted in compliance in all material respects with all applicable Health Care LawsLaws pertaining to the manufacture and post market surveillance of Drugs, Devices, and Biologics, including, without limitation, the FDA’s current good manufacturing practice regulations at pertaining to drugs (21 CFR Part 820Parts 210 and 211 et seq.), and, to the extent applicable, the respective counterparts thereof governing manufacturing operations promulgated by other Health Regulatory Agencies. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Disclosure Package and the Prospectus, the Company has not had any manufacturing site (whether Company-owned by the Company or, to the knowledge of the Company, that of a third party manufacturer for of the Company’s products) subject to a an FDA or other Health Regulatory Agencies (including FDA) shutdown or Agency consent decree, seizure, import alert, or export prohibition, nor received any FDA or other Health Regulatory Agency “warning letters,” or “untitled letters” alleging or asserting material noncompliance with any applicable Health Care Laws, requests to make material changes to the Company’s products, processes or operations, or similar correspondence or notice operations from the FDA or other Health Regulatory Agencies alleging or asserting material noncompliance with any applicable Health Care LawsAgency, other than those that have been satisfactorily addressed and/or closed with the FDA or other Health Regulatory AgenciesAgency. To the knowledge of the Company’s knowledge, neither none of the FDA nor or any other Health Regulatory Agencies Agency is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s products by or, to the knowledge of the Company, on behalf of the Company is being conducted in compliance in all material respects with all applicable Health Care Laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part Parts 210, 211, and 820, and, to the extent applicable, the respective counterparts thereof promulgated by other Health Regulatory Agenciesgovernmental authorities in countries outside the United States. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package and the Prospectus, the Company has not had any manufacturing site (whether Company-owned or, to the knowledge of the Company, that of a third party manufacturer for the Company’s products) subject to a Health Regulatory Agencies governmental authority (including FDA) shutdown or import or export prohibition, nor received any FDA or other Health Regulatory Agency governmental authority “warning letters,” or “untitled letters,” alleging or asserting material noncompliance with any applicable Health Care Laws, requests to make material changes to the Company’s products, processes or operations, or similar correspondence or notice from the FDA or other Health Regulatory Agencies governmental authority alleging or asserting material noncompliance with any applicable Health Care Laws, other than those that have been satisfactorily addressed and/or closed with the FDA or other Health Regulatory Agenciesgovernmental authority. To the Company’s knowledge, neither the FDA nor any other Health Regulatory Agencies governmental authority is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s products by the Company or, to the knowledge of the Company, on behalf of the Company Company, is being conducted in compliance in all material respects with all applicable Health Care LawsLaws and I the FDA regulation pertaining to the manufacture and post market surveillance of Drugs, Devices, and Biologics, including, without limitation, the FDA’s current good manufacturing practice regulations at regulations, or CGMPs, pertaining to drugs (21 CFR Part 820Parts 210 and 211 et seq.), and, to the extent applicable, the respective counterparts thereof governing manufacturing operations promulgated by other Health Regulatory Agencies. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package and the Prospectus, the Company has not had any manufacturing site (whether Company-owned by the Company or, to the knowledge of the Company, that of a third party manufacturer for of the Company’s products) subject to a an FDA or other Health Regulatory Agencies (including FDA) shutdown or Agency consent decree, seizure, import alert, or export prohibition, nor received any FDA or other Health Regulatory Agency “warning letters,” or “untitled letters” alleging or asserting material noncompliance with any applicable Health Care Laws, requests to make material changes to the Company’s products, processes or operations, or similar correspondence or notice operations from the FDA or other Health Regulatory Agencies alleging or asserting material noncompliance with any applicable Health Care LawsAgency, other than those that have been satisfactorily addressed and/or closed with the FDA or other Health Regulatory AgenciesAgency. To the knowledge of the Company’s knowledge, neither none of the FDA nor or any other Health Regulatory Agencies Agency is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s products by or, to the knowledge of the Company, on behalf of the Company is being conducted in compliance in all material respects with all applicable Health Care Laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820, and, to the extent applicable, the respective counterparts thereof promulgated by other Health Regulatory Agenciesgovernmental authorities in countries outside the United States. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package and the Prospectus, the Company has not had any manufacturing site (whether Company-owned or, to the knowledge of the Company, that of a third party manufacturer for the Company’s products) subject to a Health Regulatory Agencies governmental authority (including FDA) shutdown or import or export prohibition, nor received any FDA or other Health Regulatory Agency governmental authority “warning letters,” or “untitled letters” alleging or asserting material noncompliance with any applicable Health Care Laws, requests to make material changes to the Company’s products, processes or operations, or similar correspondence or notice from the FDA or other Health Regulatory Agencies governmental authority alleging or asserting material noncompliance with any applicable Health Care Laws, other than those that have been satisfactorily addressed and/or closed with the FDA or other Health Regulatory Agenciesgovernmental authority. To the Company’s knowledge, neither the FDA nor any other Health Regulatory Agencies governmental authority is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s and its subsidiaries’ products by or, to the knowledge of the Company, or on behalf of the Company and its subsidiaries is being conducted in compliance in all material respects with all applicable Health Care Laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820, and, to the extent applicable, the respective counterparts thereof promulgated by other Health Regulatory Agenciesgovernmental authorities in countries outside the United States. Except as disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, Neither the Company has not nor its subsidiaries have had any manufacturing site (whether Company-owned, subsidiary-owned or, to the knowledge of the Company, or that of a third party manufacturer for the Company’s or its subsidiaries’ products) subject to a Health Regulatory Agencies Governmental Authority (including FDAFDA or EMA) shutdown or import or export prohibition, nor received any FDA FDA, EMA or other Health Regulatory Agency Governmental Authority “warning letters,” or “untitled letters” alleging or asserting material noncompliance with any applicable Health Care Laws, requests to make material changes to the Company’s or its subsidiaries’ products, processes or operations, or similar correspondence or notice from the FDA FDA, EMA or other Health Regulatory Agencies Governmental Authority alleging or asserting material noncompliance with any applicable Health Care Laws, other than those that have been satisfactorily addressed and/or closed with the FDA FDA, EMA or other Health Regulatory AgenciesGovernmental Authority. To the knowledge of the Company’s knowledge, neither the FDA nor FDA, EMA or any other Health Regulatory Agencies Governmental Authority is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s products by or, to the knowledge of the Company, on behalf of the Company is being conducted in compliance in all material respects with all applicable Health Care Laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820, and, to the extent applicable, the respective counterparts thereof promulgated by other Health Regulatory Agencies. Except as disclosed in the Registration Statement, the Time of Sale Prospectus General Disclosure Package and the Prospectus, the Company has not had any manufacturing site (whether Company-owned or, to the knowledge of the Company, that of a third party manufacturer for the Company’s products) subject to a Health Regulatory Agencies (including FDA) shutdown or import or export prohibition, nor received any FDA or other Health Regulatory Agency “warning letters,” or “untitled letters” alleging or asserting material noncompliance with any applicable Health Care Laws, requests to make material changes to the Company’s products, processes or operations, or similar correspondence or notice from the FDA or other Health Regulatory Agencies alleging or asserting material noncompliance with any applicable Health Care Laws, other than those that have been satisfactorily addressed and/or closed with the FDA or other Health Regulatory Agencies. To the Company’s and its subsidiary’s knowledge, neither the FDA nor any other Health Regulatory Agencies is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s products by orand its Subsidiaries’ product candidates, or to the knowledge of the Company, by or on behalf of the Company and its Subsidiaries is being conducted in compliance in all material respects with all applicable Health Care Laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820600, 601, 610 and 21 CFR Part 1271, as applicable, and, to the extent applicable, the respective counterparts thereof promulgated by other Health Regulatory Agenciesany Governmental Authority. Except as disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, Neither the Company nor any of its Subsidiaries has not had any manufacturing site (whether Company-owned, Subsidiary-owned or, to the knowledge of the Company, or that of a third party manufacturer for the Company’s productsor its Subsidiaries’ product candidates) subject to a Health Regulatory Agencies (including FDA) Governmental Authority shutdown or import or export prohibition, nor received any FDA or other Health Regulatory Agency “written notice of adverse filing, warning letters,” or “letter, untitled letters” alleging or asserting material noncompliance with any applicable Health Care Lawsletter, requests to make material changes to the Company’s productsor its Subsidiaries’ product candidates, processes or operations, or similar correspondence or notice from the FDA or any other Health Regulatory Agencies Governmental Authority alleging or asserting material noncompliance with any applicable Health Care Laws, other than those that have been satisfactorily addressed and/or closed with the FDA or other Health Regulatory AgenciesGovernmental Authority. To the knowledge of the Company’s knowledge, neither the FDA nor any other Health Regulatory Agencies Governmental Authority is considering such action.