(cc) Compliance with Health Care Laws. Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company and its subsidiaries are, and at all times since the Company’s inception on May 15, 2019 have been, in compliance with all Health Care Laws (defined herein), including, but not limited to, the rules and regulations of the U.S. Department of Health and Human Services Office of Inspector General, the Centers for Medicare & Medicaid Services, the HHS Office for Civil Rights, the U.S. Department of Justice and any other governmental agency or body having jurisdiction over the Company or any of its properties, and has not, since the Company’s inception on May 15, 2019, engaged in any activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other local, state or federal healthcare program. For purposes of this Agreement, “Health Care Laws” shall mean the U.S. Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.); the federal Anti-kickback Statute (42 U.S.C. § 1320a-7b(b)), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the criminal False Claims Act (42 U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. §§ 286, 287, and the health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §§ 1320d et seq.) (“HIPAA”), the exclusions law (42 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. Neither the Company nor any of its subsidiaries and each of their directors, officers, and employees, and to the Company’s knowledge, their 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. Neither the Company, any of its subsidiaries nor any of their respective directors, officers, and employees, and to the Company’s knowledge, their respective agents, affiliates and representatives, have not received any written notification, correspondence or any other written communication, and neither the Company nor any of its subsidiaries has received any oral communication, from any governmental authority of potential or actual non-compliance by, or liability of, the Company or any of its subsidiaries under any Health Care Laws.
(dd) All Necessary Permits, etc. The Company and each of its subsidiaries 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 neither the Company nor any of its subsidiaries is in material violation of any term or conditions of any such License. The Company and each of its subsidiaries 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. Neither the Company nor its subsidiaries have 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 or its subsidiaries.
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