U.S.C.§ 1320a-7), the civil monetary penalties law (42 U.S.C.§ 1320a-7a), Medicare (Title XVIII of the Social Security Act), and Medicaid (Title XIX of the Social Security Act), each as amended, and the regulations promulgated thereunder. The Company and each of its directors, officers, and employees, and to the Company’s knowledge, its agents, affiliates and representatives, are not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreement, monitoring agreement, consent decree, settlement order, plan of correction or similar agreement imposed by any governmental authority. The Company and its directors, officers, and employees, and to the Company’s knowledge, its agents, affiliates and representatives, have not received any written notification, correspondence or any other written communication, and the Company has not received any oral communication, from any governmental authority of potential or actualnon-compliance by, or liability of, the Company under any Health Care Laws;
(ff) The Company possesses, and is in compliance with the terms of, all applications, certificates, approvals, clearances, registrations, exemptions, franchises, licenses, permits, consents and other authorizations necessary to conduct its business (collectively, “Licenses”), issued by the appropriate federal, state, local or foreign governmental or regulatory authorities including, without limitation, from the FDA and equivalent foreign regulatory authorities (collectively, the “Regulatory Agencies”), except where the failure to possess or comply with the same would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. All such Licenses are in full force and effect and the Company is not in material violation of any term or conditions of any such License. The Company has fulfilled and performed all of its material obligations with respect to such Licenses 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 impairment of the rights of the holder of any such License. The Company has not received any written, and to the Company’s knowledge, oral, notice of proceedings relating to the revocation or material adverse modification of any such Licenses and, to the Company’s knowledge, no Regulatory Agency has taken any action to materially limit, suspend or revoke any such License possessed by the Company;
(gg) Neither the Company, nor, to the Company’s knowledge, any of its officers, employees, directors, or agents, have been excluded, suspended or debarred from participation in any U.S. federal health care program or, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or convicted of any crime or engaged in any conduct that would reasonably be expected to result in any suspension, exclusion, or debarment;
(hh) Except as described in the Pricing Disclosure Package, the Company owns or has valid and enforceable licenses or other rights to use all patents and patent applications, copyrights, trademarks, trademark registrations, service marks, service mark registrations, trade names, service names andknow-how (including trade secrets and other unpatented and/or unpatentable proprietary or confidential information, inventions, systems or procedures) including the right to sue for past, present and future infringement, misappropriation or dilution of any of the foregoing, to the extent the foregoing are necessary for the conduct of the business of the Company in the manner described in the Pricing Disclosure Package and the Prospectus (collectively, the “Company Intellectual Property”). Other than as disclosed in the Pricing Disclosure Package, there are no rights of third parties to any of the material patents, trademarks and copyrights within the
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