Common use of Healthcare Regulatory Compliance Clause in Contracts

Healthcare Regulatory Compliance. Except as would not reasonably be expected to have a Material Adverse Effect, the Company has operated and is currently in compliance with all applicable Health Care Laws (defined herein), and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal health care program. For purposes of this Agreement, “Health Care Laws” shall mean the 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 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, 1035, 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); the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h); HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §§ 17921 et seq.); the Medicare statute (Title XVIII of the Social Security Act); the Medicaid statute (Title XIX of the Social Security Act); the regulations promulgated pursuant to such laws and any other similar local, state or federal law and regulations. The Company has not received any U.S. Food and Drug Administration (“FDA”) Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence, communication or notice from the U.S. Food and Drug Administration or any other governmental or regulatory authority alleging or asserting material noncompliance with any Health Care Laws, and, to the Company’s knowledge, no claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company is not a party to nor does it have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. The Company, or any of its employees, officers, directors or agents has not been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research, or, to the Company’s knowledge, is subject to a governmental inquiry, investigation, proceeding, or other similar action that would reasonably be expected to result in debarment, suspension or exclusion.

Healthcare Regulatory Compliance. Except as would Section 3.16.1 The Company is not reasonably be expected to have a Material Adverse Effect, the Company has operated and is currently in compliance with all applicable Health Care Laws (defined herein), and has not engaged in activities which are, as applicable, cause for false claims liability, civil penaltiesparty to, or mandatory or permissive exclusion from Medicarebound by, Medicaida Corporate Integrity Agreement with the Office of Inspector General of the U.S. Department of Health and Human Services, or any other state monitoring agreements, special reporting obligations, consent decrees, settlement agreements, or federal similar agreements imposed by any Governmental Entity concerning compliance with Health Care Laws and has not been required to pay any fines or penalties relating to or arising from any alleged or actual violation of any Health Care Law. Section 3.16.2 The Company is in compliance in all material respects with all health care program. For purposes of this Agreementlaws applicable to the Company, “Health Care Laws” shall mean the Federal Foodincluding, Drugbut not limited to, and Cosmetic Act (21 U.S.C. §§ 301 et seq.); the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)); , the civil False Claims Act (31 U.S.C. §§ 3729 et seq.); , the criminal False Claims Act prohibition against false statements or representations (42 U.S.C. § 1320a-7b(a)); all criminal laws relating to health care fraud and abuse, including but not limited to 18 the Civil Monetary Penalties Law (42 U.S.C. Sections 286§§ 1320a-7a), 287, 1035, 1347 and 1349, and the health care fraud criminal provisions under statute (18 U.S.C. § 1347) the federal Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), 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); the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h); HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §§ 17921 et seq.); , the exclusion laws (42 U.S.C. § 1320a-7), Medicare statute (Title XVIII of the Social Security Act); the , Medicaid statute (Title XIX of the Social Security Act); ) and the regulations promulgated pursuant to such laws Laws and any Laws of a Governmental Entity addressing any of the foregoing types of matters (collectively, the “Health Care Laws”). Section 3.16.3 Section 3.16.3 of the Company Disclosure Schedule sets forth a complete and accurate list and description of financial (whether investment, financing, compensatory or otherwise) or other similar localcontractual relationships the Company or any of its Affiliates currently have with any physician or other health care provider or professional or any agent, state Affiliate or federal law immediate family member of any such person or entity, and regulations. the Company has provided the Purchaser Parties with complete and accurate copies of all Contracts documenting or relating to such arrangements (or in the case of an oral Contract, the Company has provided the Purchase Parties with a written description of all material terms of each such Contract). Section 3.16.4 The Company has not received any U.S. Food and Drug Administration (“FDA”) Form 483notification of any pending or, notice to the Knowledge of adverse findingthe Company, warning letterthreatened, untitled letter or other correspondenceAction from any Governmental Entity, communication or notice from including, without limitation, the Centers for Medicare & Medicaid Services, the U.S. Food Department of Health and Drug Administration Human Services Office of Inspector General, the U.S. Department of Justice or any other governmental state attorney or regulatory authority agency alleging potential or asserting material noncompliance with actual non-compliance by, or liability of, the Company under any Health Care Laws, and. Section 3.16.5 Neither the Company nor, to the Company’s knowledge, no claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company is not a party to nor does it have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans Knowledge of correction or similar agreements with or imposed by any governmental or regulatory authority. The the Company, or any of its employees, officers, directors director or agents has not been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research, or, to the Company’s knowledgecontractors currently providing services, is subject to a governmental inquiry, investigation, proceedingor has been, or other similar action is the subject of any inquiry that would could reasonably be expected to result in debarmentthe Company or such person being: (i) excluded, suspension debarred or exclusionsuspended from or otherwise ineligible to participate in a “Federal Health Care Program” as defined in 42 U.S.C. 1320a-7b(f), as amended from time to time; (ii) charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program; (iii) had a civil monetary penalty assessed against it under Section 1128A of the Social Security Act; or (iv) listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs. To the Knowledge of the Company, none of its employees, officers or directors is: (i) excluded, debarred or suspended from or otherwise ineligible to participate in a “Federal Health Care Program” as defined in 42 U.S.C. 1320a-7b(f), as amended from time to time, or any other governmental payment, procurement or non-procurement program or (ii) listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs. Section 3.16.6 To the Knowledge of the Company, no person or entity has filed or threatened to file against the Company an Action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).

Healthcare Regulatory Compliance. Except as would not reasonably be expected to The Company and its subsidiaries have a Material Adverse Effect, the Company has operated and is are currently in compliance in all material respects with all applicable Health Care Laws (defined herein), and has have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal health care program. For purposes of this Agreement, “Health Care Laws” shall mean the 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 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, 1035, 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); the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h); HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §§ 17921 et seq.); the Medicare statute (Title XVIII of the Social Security Act); the Medicaid statute (Title XIX of the Social Security Act); the regulations promulgated pursuant to such laws and any other similar local, state or federal law and regulations. The Neither the Company nor any of its subsidiaries has not received any U.S. Food and Drug Administration (“FDA”) FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence, communication or notice from the U.S. Food and Drug Administration or any other governmental or regulatory authority alleging or asserting material noncompliance with any Health Care Laws, and, to the Company’s knowledge, no claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Neither the Company nor any of its subsidiaries is not a party to nor does it have or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. The Neither the Company, or any of its subsidiaries nor any of their respective employees, officers, directors or agents has not been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research, or, to the Company’s knowledge, is subject to a governmental inquiry, investigation, proceeding, or other similar action that would reasonably be expected to result in debarment, suspension or exclusion.

Healthcare Regulatory Compliance. Except as would not reasonably be expected to The Company and its subsidiaries have a Material Adverse Effect, the Company has operated and is are currently in compliance in all material respects with all applicable Health Care Laws (defined herein), and has have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal health care program. For purposes of this Agreement, “Health Care Laws” shall mean the 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 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, 1035, 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); the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h); HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §§ 17921 et seq.); the Medicare statute (Title XVIII of the Social Security Act); the Medicaid statute (Title XIX of the Social Security Act); the regulations promulgated pursuant to such laws and any other similar local, state or federal law and regulations. The Neither the Company nor any of its subsidiaries has not received any U.S. Food and Drug Administration (“FDA”) Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence, communication or notice from the U.S. Food and Drug Administration FDA or any other governmental or regulatory authority Regulatory Agency alleging or asserting material noncompliance with any Health Care Laws, except as would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Change, and, to the Company’s knowledge, no claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Neither the Company nor any of its subsidiaries has, either voluntarily or involuntarily, initiated, conducted or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post-sale warning, “dear health care provider” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, no third-party has initiated or conducted any such notice or action. Neither the Company nor any of its subsidiaries is not a party to nor does it have or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authorityauthority or Regulatory Agency. The Neither the Company, or any of its subsidiaries nor any of their respective employees, officers, directors or agents has not been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research, or, to the Company’s knowledge, is subject to a governmental inquiry, investigation, proceeding, or other similar action that would reasonably be expected to result in debarment, suspension or exclusion.

Healthcare Regulatory Compliance. Except as would not reasonably be expected to have a Material Adverse Effect, the The Company has operated and is currently in compliance in all material respects with all applicable Health Care Laws (defined herein), and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal health care program. For purposes of this Agreement, “Health Care Laws” shall mean the 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 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, 1035, 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); the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h); HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §§ 17921 et seq.); the Medicare statute (Title XVIII of the Social Security Act); the Medicaid statute (Title XIX of the Social Security Act); the regulations promulgated pursuant to such laws and any other similar local, state or federal law and regulations. The Company has not received any U.S. Food and Drug Administration (“FDA”) FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence, communication or notice from the U.S. Food and Drug Administration or any other governmental or regulatory authority alleging or asserting material noncompliance with any Health Care Laws, and, to the Company’s knowledge, no claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company is not a party to nor does it have has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. The Company, or Neither the Company nor any of its employees, officers, directors or agents has not been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research, or, to the Company’s knowledge, is subject to a governmental inquiry, investigation, proceeding, or other similar action that would reasonably be expected to result in debarment, suspension or exclusion.

Healthcare Regulatory Compliance. Except as would not reasonably be expected to The Company and its subsidiaries have a Material Adverse Effect, the Company has operated and is are currently in compliance in all material respects with all applicable Health Care Laws (defined herein), and has have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal health care program. For purposes of this Agreement, “Health Care Laws” shall mean the 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 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, 1035, 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); the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h); HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §§ 17921 et seq.); the Medicare statute (Title XVIII of the Social Security Act); the Medicaid statute (Title XIX of the Social Security Act); the regulations promulgated pursuant to such laws and any other similar local, state or federal law and regulations. The Neither the Company nor any of its subsidiaries has not received any U.S. Food and Drug Administration (“FDA”) Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence, communication or notice from the U.S. Food and Drug Administration or any other governmental or regulatory authority alleging or asserting material noncompliance with any Health Care Laws, and, to the Company’s knowledge, no claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Neither the Company nor any of its subsidiaries is not a party to nor does it have or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. The Neither the Company, or any of its subsidiaries nor any of their respective employees, officers, directors or agents has not been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research, or, to the Company’s knowledge, is subject to a governmental inquiry, investigation, proceeding, or other similar action that would reasonably be expected to result in debarment, suspension or exclusion.