(kk) Compliance with Healthcare Laws and Regulations. Except as
disclosed in the SEC Reports, the Company and the Subsidiary and, to the Companys Knowledge, their respective directors, employees and agents (while acting in such capacity) are in material compliance with all health care laws applicable to
the Company and the Subsidiary, or any of their products or activities, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the Civil Monetary Penalties Law (42
U.S.C. § 1320a-7a), the civil False Claims Act (31 U.S.C. § 3729 et seq.), the criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), the Stark law (42
U.S.C. § 1395nn), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.) as amended by the
Health Information Technology for Economic and Clinical Health Act (42 U.S.C. § 17921 et seq.) (HIPAA), all criminal laws relating to healthcare fraud and abuse, including but not limited to 18 U.S.C. §§ 286 and
287, the healthcare fraud criminal provisions under HIPAA, the exclusion laws (42 U.S.C. § 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.), the Controlled Substances Act
(21 U.S.C. § 801 et seq.), the Public Health Service Act (42 U.S.C. § 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. § 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of
the Social Security Act), TRICARE (10 U.S.C. § 1071 et seq.), any state corporate practice or fee-splitting prohibitions, and any state or federal anti-markup or comparable laws or regulations, the
regulations promulgated pursuant to such laws, and any other state, federal or foreign law, accreditation standards, regulation, memorandum, opinion letter or other issuance which imposes requirements on the manufacturing, development, testing,
labeling, advertising, marketing or distribution of drugs, biologics and medical devices, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or
acquisition of services or supplies from those who have been excluded from government health care programs, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics
products or services (collectively, Health Care Laws). None of the Company, the Subsidiary or any of their respective officers, directors, employees or, to the Companys Knowledge, agents, have engaged in activities which
are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, TRICARE or any other state or federal healthcare program (collectively, the Programs). Except as
disclosed in the SEC Reports, none of the Company or the Subsidiary has received any notification, correspondence or any other written or, to the Companys Knowledge, oral communication, including notification of any pending or threatened
claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (Action) from any governmental authority, including, without limitation, the FDA, the EMA, Health Canada, the United States Federal Trade
Commission, the United States Drug Enforcement Administration, CMS, HHSs Office of Inspector General, the United States Department of Justice and state Attorneys General or similar agencies of potential or actual
non-compliance by, or liability of, the Company or the Subsidiary under any Health Care Laws, except, with respect to any of the foregoing, such as would not, individually or in the aggregate, be material to
the Company or the Subsidiary. Except as disclosed in the SEC Reports, to the Companys Knowledge, there are no facts or circumstances that would reasonably be expected to give rise to material liability of the Company or the Subsidiary under
any Health Care Laws. Except as set forth in the SEC Reports, neither the Company nor its Subsidiary is a party to, and 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 or regulatory authority. Additionally, none of the Company, its Subsidiary or any of its respective employees, officers or directors,
nor to the Companys Knowledge, any of its agents, has been excluded, suspended or debarred from participation in any Program or human clinical research or, to the Companys Knowledge, is subject to a governmental inquiry, investigation,
proceeding, or other similar Action that could reasonably be expected to result in debarment, suspension, or exclusion. The statements with respect to Health Care Laws and the Companys and the Subsidiarys compliance therewith included in
the SEC Reports fairly summarize the matters therein described.
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