Common use of FDA Compliance Clause in Contracts

FDA Compliance. Neither the Company nor any of its subsidiaries has knowledge of any actual or threatened enforcement action against the Company or any of its subsidiaries by the FDA or any other governmental entity which has jurisdiction over the operations of the Company or any of the Company’s subsidiaries. All material reports, documents, claims and notices required to be filed, maintained, or furnished to the FDA or any governmental entity by the Company or the Company’s subsidiaries have been so filed, maintained or furnished. All such reports, documents, claims, and notices were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing) such that no material liability exists with respect to the completeness or accuracy of such filing. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor any of the Company’s subsidiaries have received any FDA Form 483, Warning Letter, material untitled letter or other correspondence or notice from the FDA or other governmental entity alleging or asserting noncompliance with any applicable Laws or Permits or received any other notice of any pending or threatened claim by the FDA or any other governmental entity which has jurisdiction over the operations of the Company and the Company’s subsidiaries against the Company or any of the Company’s subsidiaries.

FDA Compliance. Neither the Company nor any of its subsidiaries has knowledge of any actual or threatened enforcement action against by the U.S. Food and Drug Administration (the “FDA”) or any other governmental entity which has jurisdiction over the operations of the Company or any of its subsidiaries the Company’s subsidiaries, and none has received notice of any pending or threatened claim by the FDA or any other governmental entity which has jurisdiction over the operations of the Company and the Company’s subsidiaries against the Company or any of the Company’s subsidiaries. All material reports, documents, claims and notices required to be filed, maintained, or furnished to the FDA or any governmental entity by the Company or the Company’s subsidiaries have been so filed, maintained or furnished. All such reports, documents, claims, and notices were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing) such that no material liability exists with respect to the completeness or accuracy of such filing. Except as described in the Registration Statement, the Pricing Disclosure Package Time of Sale Information and the Prospectus, neither the Company nor any of the Company’s subsidiaries have received any FDA Form 483, Warning Letter, material untitled letter or other correspondence or notice from the FDA or other governmental entity alleging or asserting noncompliance with any applicable Laws or Permits or received any other notice of any pending or threatened claim by the FDA or any other governmental entity which has jurisdiction over the operations of the Company and the Company’s subsidiaries against the Company or any of the Company’s subsidiariesPermits.

FDA Compliance. Neither the Company nor any of its subsidiaries has knowledge of any actual or threatened enforcement action against the Company or any of its subsidiaries by the FDA or any other governmental entity which has jurisdiction over the operations of the Company or any of the Company’s subsidiaries. All material reports, documents, claims and notices required to be filed, maintained, or furnished to the FDA or any governmental entity by the Company or the Company’s subsidiaries have been so filed, maintained or furnished, except where the failure to file, maintain, or furnish the same would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. All such reports, documents, claims, and notices were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing) such that no material liability exists with respect to the completeness or accuracy of such filing. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither Neither the Company nor any of the Company’s subsidiaries have received received, and then failed to cure any material deficiencies reflected in, any FDA Form 483, Warning Letterwarning letter, material untitled letter or other correspondence or notice from the FDA or other governmental entity alleging or asserting noncompliance with any applicable Laws laws or Permits permits or received any other notice of any pending or threatened claim by the FDA or any other governmental entity which has jurisdiction over the operations of the Company and the Company’s subsidiaries against the Company or any of the Company’s subsidiaries.

FDA Compliance. Neither the Company nor any of its subsidiaries has knowledge of any actual or threatened enforcement action against by the U.S. Food and Drug Administration (the “FDA”) or any other governmental entity which has jurisdiction over the operations of the Company or any of its subsidiaries the Company’s subsidiaries, and none has received notice of any pending or threatened claim by the FDA or any other governmental entity which has jurisdiction over the operations of the Company and the Company’s subsidiaries against the Company or any of the Company’s subsidiaries. All material reports, documents, claims and notices required to be filed, maintained, or furnished to the FDA or any governmental entity by the Company or the Company’s subsidiaries have been so filed, maintained or furnished. All such reports, documents, claims, and notices were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing) such that no material liability exists with respect to the completeness or accuracy of such filing. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor any of the Company’s subsidiaries have received any FDA Form 483, Warning Letter, material untitled letter or other correspondence or notice from the FDA or other governmental entity alleging or asserting noncompliance with any applicable Laws or Permits or received any other notice of any pending or threatened claim by the FDA or any other governmental entity which has jurisdiction over the operations of the Company and the Company’s subsidiaries against the Company or any of the Company’s subsidiariesPermits.