Common use of Health Care Products Manufacturing Clause in Contracts

Health Care Products Manufacturing. The manufacture of products by the Company and its subsidiaries or, to the knowledge of the Company, on behalf of the Company or its subsidiaries, is being conducted in compliance in all material respects with all Health Care Laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820, and, to the extent applicable, any counterpart thereof promulgated by governmental authorities in countries outside the United States. The Company and its subsidiaries have not had any manufacturing site subject to a governmental authority (including FDA) shutdown or import or export prohibition, nor received any FDA or other governmental authority “warning letters,” “untitled letters,” requests to make changes to the products of the Company, processes or operations, or similar correspondence or notice from the FDA or other governmental authority alleging or asserting material noncompliance with all Health Care Laws, other than those that have been satisfactorily addressed and/or closed with the FDA or other governmental authority. To the Company’s knowledge, neither the FDA nor any other governmental authority is considering such action.

Health Care Products Manufacturing. The manufacture of products by the Company and its subsidiaries or, to the knowledge of the Company, ’s product candidates by or on behalf of the Company or 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, any counterpart the respective counterparts thereof promulgated by governmental authorities in countries outside the United States. The Company and its subsidiaries have has not had any manufacturing site (whether Company-owned, or that of a third party manufacturer for the Company’s product candidates) subject to a governmental authority Governmental Authority (including FDA) shutdown or import or export prohibition, nor received any FDA or other governmental authority 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 products of the Company’s product candidates, processes or operations, or similar correspondence or notice from the FDA or other governmental authority Governmental Authority alleging or asserting material noncompliance with all any applicable Health Care Laws, other than those that have been satisfactorily addressed and/or closed with the FDA or other governmental authorityGovernmental Authority. To the knowledge of the Company’s knowledge, neither the FDA nor any other governmental authority Governmental Authority is considering such action.