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, to the knowledge of the Company, 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, in the past three (3) years, received any unresolved 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. To the Company’s knowledge, neither the FDA nor any other governmental authority is considering such action.

No Shutdowns or Prohibitions. The Neither the Company nor its subsidiaries has not had any product, clinical laboratory or manufacturing site (whether Company-owned or, to the knowledge of the Company, or that of a third-third party manufacturer for the Company’s and its subsidiaries’ products) subject to a governmental authority (including FDA) shutdown or import or export prohibition, nor, in the past three (3) years, nor received any unresolved FDA Form 483 or other governmental authority notice of inspectional observations, “warning letters,” “untitled letters,” requests to make changes to the Company’s and its subsidiaries’ 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. To the Company’s knowledge, neither the FDA nor any other governmental authority is considering such action.

No Shutdowns or Prohibitions. The Except as disclosed in the Registration Statement and the Prospectus, in the last five years, the Company has not had any product, clinical laboratory product or manufacturing site (whether Company-owned or, to the knowledge of the Company, or that of a third-third party contract manufacturer for the Company’s products) subject to a governmental authority (including FDA) shutdown or import or export prohibition, nor, in the past three (3) years, nor received any unresolved 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 written correspondence or notice from the FDA or other governmental authority alleging or asserting material noncompliance with any applicable Health Care Applicable Laws. To the Company’s knowledge, neither the FDA nor any other governmental authority is considering such action.