Common use of No Shutdowns or Prohibitions Clause in Contracts

No Shutdowns or Prohibitions. The Company has not had any product, clinical laboratory or manufacturing site (whether Company-owned or that of a third party manufacturer for the Company’s products) subject to a Governmental Authority (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other Governmental Authority notice of inspectional observations, “warning letters,” “untitled letters,” requests to make changes to the Company’s products, processes or operations, or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting material noncompliance with any applicable Health Care Laws; provided, however, that, with respect to third-party clinical laboratories or manufacturers, the foregoing is limited only to such regulatory actions or prohibitions that are directly related to the Company’s products or product candidates or any other service provided to the Company or that could result in a Material Adverse Effect. To the Company’s knowledge, neither the FDA nor any other Governmental Authority is considering any such action.

No Shutdowns or Prohibitions. The Company has not had any product, clinical laboratory or manufacturing site (whether Company-owned or that of a third party manufacturer for the Company’s products) subject to a Governmental Authority governmental authority (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other Governmental Authority governmental authority notice of inspectional observations, “warning letters,” “untitled letters,” requests to make changes to the Company’s products, processes or operations, or similar correspondence or notice from the FDA or other Governmental Authority governmental authority alleging or asserting material noncompliance with any applicable Health Care Laws; Laws; provided, however, that, with respect to third-party clinical laboratories or manufacturers, the foregoing is limited only to such regulatory actions or prohibitions that are directly related to the Company’s products or product candidates or any other service provided to the Company or that could would result in a Material Adverse Effect. To the Company’s knowledge, neither the FDA nor any other Governmental Authority governmental authority is considering any such action.

No Shutdowns or Prohibitions. The Company has not had any product, clinical laboratory or manufacturing site (whether Company-owned or that of a third party manufacturer for the Company’s products) subject to a Governmental Authority (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other Governmental Authority notice of inspectional observations, “warning letters,” “untitled letters,” requests to make changes to the Company’s products, processes or operations, or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting material noncompliance with any applicable Health Care Laws; provided, however, that, with respect to third-party clinical laboratories or manufacturers, the foregoing is limited only to such regulatory actions or prohibitions that are directly related to the Company’s products or product candidates or any other service provided to the Company or that could would result in a Material Adverse Effect. To the Company’s knowledge, neither the FDA nor any other Governmental Authority is considering any such action.

No Shutdowns or Prohibitions. The Company has not had any product, clinical laboratory or manufacturing site (whether Company-owned or that of a third party manufacturer for the Company’s products) subject to a Governmental Authority governmental authority (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other Governmental Authority governmental authority notice of inspectional observations, “warning letters,” “untitled letters,” requests to make changes to the Company’s products, processes or operations, or similar correspondence or notice from the FDA or other Governmental Authority governmental authority alleging or asserting material noncompliance with any applicable Health Care Laws; provided, however, that, with respect to third-party clinical laboratories or manufacturers, the foregoing is limited only to such regulatory actions or prohibitions that are directly related to the Company’s products or product candidates or any other service provided to the Company or that could would result in a Material Adverse Effect. To the Company’s knowledge, neither the FDA nor any other Governmental Authority governmental authority is considering any such action.