(ee) The Company and, to the Company’s knowledge, its directors, officers, employees and its respective agents, affiliates and representatives, are, and at all times since July 1, 2018, has been in compliance with all applicable Health Care Laws (defined herein), except for such noncompliance that would not, individually or in the aggregate, have a Material Adverse Effect. 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, 1347 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 laws (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.), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), the Public Health Service Act (42 U.S.C. §§ 201 et seq.), and similar laws of any other national, federal, state or local governmental or regulatory body or authority, and the rules and regulations thereunder. Since July 1, 2018, and except as would not, individually or in the aggregate, have a Material Adverse Effect, the Company has filed, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any applicable 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). The Company is not a party to and does not have 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. Since July 1, 2018, the Company has not received any written notification or correspondence or any other written communication from the FDA or any similar regulatory authority alleging material noncompliance with any applicable Health Care laws, including, without limitation, any FDA Form 483, notice of adverse finding, warning letter, untitled letter, or any written notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action, from any arbitrator or regulatory or governmental authority or third party alleging potential or actual non-compliance by, or liability of, the Company under any Health Care Laws in any material respect;
(ff) Since July 1, 2018, and except as would not, individually or in the aggregate, have a Material Adverse Effect, the Company has possessed and currently possesses all certificates, approvals, clearances, registrations, exemptions, franchises, licenses, permits, consents and other authorizations issued by governmental authorities, including, without limitation, those required by the FDA, or any component thereof, and/or by any other U.S., state, local or foreign government or drug regulatory agency (collectively, the “Regulatory Agencies”) necessary to conduct its business as currently conducted (collectively, “Licenses”). All such Licenses are in full force and effect and the Company is not in violation of any term or conditions of any License, except for such violations that would not, individually or in the aggregate, have a Material Adverse Effect. Since July 1,
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