suspend, modify or revoke any Regulatory Authorizations nor, to the Companys knowledge, is any such limitation, suspension, modification or revocation threatened; (v) have not received any notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action, or any U.S. Food and Drug Administration (FDA) Form 483, notice of adverse finding, warning letter, untitled letter or other communication from any court or arbitrator or governmental or regulatory authority alleging or asserting non-compliance with any Applicable Regulatory Laws or Regulatory Authorizations, nor, to the Companys knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action or communication threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Regulatory Laws or Regulatory Authorizations, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority.
(ee) All clinical and pre-clinical trials conducted by or on behalf of, or sponsored by, the Company or its Subsidiary, or in which the Company or its Subsidiary have participated, that are described or referred to in the Registration Statement and the Time of Sale Prospectus were and, if still pending, are being conducted, in all material respects, in compliance with the experimental protocols established for such trials, with accepted medical and scientific standards, and with all Applicable Regulatory Laws, including regulations relating to Good Clinical Practices and Good Laboratory Practices, and all Regulatory Authorizations. The descriptions of the clinical and pre-clinical trials, including the results thereof, included in the Registration Statement and the Time of Sale Prospectus are accurate and complete in all material respects and fairly present the data derived from such trials in all material respects; and neither the Company nor its Subsidiary is aware of any other clinical or pre-clinical trials, the results of which reasonably call into question the results described in the Registration Statement and the Time of Sale Prospectus. Neither the Company nor its Subsidiary have received any notices or correspondence from FDA or similar foreign, state, and local governmental or regulatory authorities (collectively, the Regulatory Authorities) or institutional review boards or comparable authorities requiring the termination, suspension, material modification or clinical hold of any clinical or pre-clinical trials conducted by or on behalf of the Company, and to the Companys knowledge, there are no reasonable grounds for the same.
(ff) Neither the Company nor the Subsidiary, or any of their respective directors, officers, employees or, to the Companys knowledge, agents, is or has been debarred, suspended or excluded, or has been convicted of any crime or engaged in any conduct that would result in debarment, suspension or exclusion by FDA or from any federal or state government health care program.