local, state or federal laws, and the rules and regulations promulgated pursuant to such laws (collectively, the “Health Care Laws”), except where failure to be so in compliance have not, and would not reasonably be expected to have a material adverse effect. The Company has not received any U.S. Food and Drug Administration (“FDA”) Form-483, notice of adverse finding, warning letter, letter of admonition, untitled letter or other correspondence or written notice from any regulatory authority or governmental authority alleging or asserting noncompliance with any Health Care Laws applicable to the Company or its subsidiary. Neither the Company nor its subsidiary, nor, to the Company’s knowledge, their officers, directors, employees, or agents, have engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal healthcare program. Neither the Company nor its subsidiary has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiary have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, 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). Neither the Company nor its subsidiary is a party to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, its subsidiary nor any of their respective employees, officers, directors, or, to the knowledge of the Company, agents, has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion;
(z) The Company and its subsidiary possess all material certificates, approvals, clearances, exemptions, registrations, franchises, licenses, permits and other authorizations necessary to the conduct of the business conducted by it as disclosed in the Registration Statement and the Pricing Prospectus (collectively, “Permits”), including without limitation, any such Permits required by the FDA or any component thereof and/or by any other U.S., state, local or foreign government or drug regulatory agency. All such Permits are in full force and effect and neither the Company nor any subsidiary is in violation of any term of such Permit in any material respect. The Company has fulfilled and performed all of its material obligations with respect to any Permits and, to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment of the rights of the holder of any Permit. Neither the Company nor any subsidiary has received any written notice of proceedings relating to the revocation or modification of any Permit that, if determined adversely to the Company, would have a material adverse effect on the Company and its subsidiary, taken as a whole. To the Company’s knowledge, no party granting any such Permit has taken any action to limit, suspend or revoke the same in any material respect;
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