Common use of Health Care Products Manufacturing Clause in Contracts

Health Care Products Manufacturing. The manufacture of the Company’s and its subsidiaries’ products or product candidates 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 in Section 21 C.F.R. Part 820, as applicable, and, to the extent applicable, the respective counterparts thereof promulgated by any Government Entity. Neither the Company nor any of its subsidiaries has had any manufacturing site (whether Company-owned, subsidiary-owned or that of a third-party manufacturer for the Company’s or its subsidiaries’ products) subject to a Governmental Entity shutdown or import or export prohibition, nor received any written notice of adverse finding, FDA or other Governmental Entity “warning letters” or “untitled letters”, requests to make material changes to the Company’s or its subsidiaries’ products or product candidates, processes or operations, or similar written correspondence or notice from the FDA or any other Governmental Entity 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 Governmental Entity. To the knowledge of the Company, neither the FDA nor any other Governmental Entity is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s and its subsidiaries’ products or product candidates 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 in Section at 21 C.F.R. CFR Part 820, as applicable, and, to the extent applicable, the respective counterparts thereof promulgated by any Government Entitygovernmental authorities in countries outside the United States. Neither the Company nor any of its subsidiaries has had any manufacturing site (whether Company-owned, subsidiary-owned or that of a third-third party manufacturer for the Company’s or its subsidiaries’ products) subject to a Governmental Entity governmental authority (including FDA) shutdown or import or export prohibition, nor received any written notice of adverse finding, FDA or other Governmental Entity 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 or product candidatesproducts, processes or operations, or similar written correspondence or notice from the FDA or any other Governmental Entity 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 Governmental Entitygovernmental authority. To the knowledge of the Company, neither the FDA nor any other Governmental Entity governmental authority is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s and its subsidiaries’ products or product candidates 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 in Section at 21 C.F.R. CFR Part 820, as applicable, and, to the extent applicable, the respective counterparts thereof promulgated by any Government Entitygovernmental authorities in countries outside the United States. Neither the Company nor any of its subsidiaries has had any manufacturing site (whether Company-owned, subsidiary-owned or that of a third-third party manufacturer for the Company’s or its subsidiaries’ products) subject to a Governmental Entity governmental authority (including the FDA) shutdown or import or export prohibition, nor received any written notice of adverse finding, FDA or other Governmental Entity 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 or product candidatesproducts, processes or operations, or similar written correspondence or notice from the FDA or any other Governmental Entity 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 Governmental Entitygovernmental authority. To the knowledge of the Company, neither the FDA nor any other Governmental Entity governmental authority is considering such action.