(dd) Insurance. The Company and its subsidiaries have insurance covering their respective properties,
operations, personnel and business, including business interruption insurance, which insurance is in amounts and insures against such losses and risks as are reasonable and is ordinary and customary for comparable companies in the same or similar
businesses; and neither the Company nor any of its subsidiaries has (i) received notice from any insurer or agent of such insurer that capital improvements or other expenditures are required or necessary to be made in order to continue such
insurance nor (ii) any reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain similar coverage at reasonable cost from similar insurers as may be necessary to continue
its business.
(ee) 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, have been, in compliance with all applicable Health Care Laws (defined herein), including, but not limited to, the rules and regulations of the Food and Drug
Administration (FDA), the U.S. Department of Health and Human Services (HHS) 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 have not 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 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. Sections 286, 287 and 1349, 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 exclusion law (42 U.S.C.
§ 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), HIPAA, as amended by the Health Information Technology for Economic
and Clinical Health Act (42 U.S.C. §§ 17921 et seq.), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.), the statutes, regulations and directives of applicable federal healthcare programs, including but not
limited to Medicare (Title XVIII of the Social Security Act) and Medicaid (Title XIX of the Social Security Act), and any rules and regulations promulgated pursuant to the statutes listed herein. The Company is 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
has not received any written notification, correspondence or any other written communication, including, without limitation, any written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any
similar regulatory authority in each case alleging material noncompliance, or any written notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action, from any court,
arbitrator, governmental or regulatory authority or third party, of potential or actual material non-compliance by, or material liability of, the Company under any Health Care Laws.
(ff) Licenses. Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, each of the Company and
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 their
respective businesses (collectively, Licenses), issued by the appropriate Governmental Authorities, including, without limitation, all Licenses required by the FDA, or any component
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