Common use of No Shutdowns or Prohibitions Clause in Contracts

No Shutdowns or Prohibitions. Except as disclosed in the Registration Statement or the Prospectus, to the Company’s knowledge, 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. To the Company’s knowledge, neither the FDA nor any other governmental authority is considering such action.

No Shutdowns or Prohibitions. Except as disclosed in the Registration Statement or Statement, in the Time of Sale Disclosure Package and in the Prospectus, to the Company’s knowledge, 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. To the Company’s knowledge, neither the FDA nor any other governmental authority is considering such action.

No Shutdowns or Prohibitions. Except as disclosed in the Registration Statement or and the Prospectus, to the Company’s knowledge, 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 productsproducts or product candidates) 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 or designated organization 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 or designated organization alleging or asserting material noncompliance with any applicable Health Care Laws. To the Company’s knowledge, neither the FDA nor any or other governmental authority Governmental Authority or designated organization is considering such action.

No Shutdowns or Prohibitions. Except as disclosed in the Registration Statement or and the Prospectus, to the Company’s knowledge, 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 productsproducts or product candidates) subject to a governmental authority (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other governmental authority or designated organization 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 or designated organization alleging or asserting material noncompliance with any applicable Health Care Laws. To the Company’s knowledge, neither the FDA nor any or other governmental authority or designated organization is considering such action.

No Shutdowns or Prohibitions. Except as disclosed in the Registration Statement or Statement, the Time of Sale Disclosure Package and the Prospectus, to the Company’s knowledge, 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 productsproducts or product candidates) subject to a governmental authority (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other governmental authority or designated organization 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 or designated organization alleging or asserting material noncompliance with any applicable Health Care Laws. To the Company’s knowledge, neither the FDA nor any or other governmental authority or designated organization is considering such action.