Common use of Compliance with Healthcare Laws and Regulations Clause in Contracts

Compliance with Healthcare Laws and Regulations. Except as disclosed in the SEC Reports, the Company, the Subsidiaries, the Managed Practice and, to the Company’s 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 Subsidiaries, or any of their products or activities, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. Section 1320a-7a), the civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Claims Law (42 U.S.C. Section 1320a-7b(a)), the Xxxxx law (42 U.S.C. Section 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. Section 1320d et seq.) as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.) (“HIPAA”), all criminal laws relating to healthcare fraud and abuse, including but not limited to 18 U.S.C. sections 286 and 287, the healthcare fraud criminal provisions under HIPAA, the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Controlled Substances Act (21 U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), TRICARE (10 U.S.C. Sections 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 (including diagnostic products and laboratory developed tests), 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 Subsidiaries, the Managed Practice or any of its respective officers, directors, employees or, to the Company’s 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, any of the Subsidiaries or the Managed Practice has received any notification, correspondence or any other written or, to the Company’s 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, HHS’s 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, the Subsidiaries or the Managed Practice 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, its Subsidiaries or the Managed Practice. Except as disclosed in the SEC Reports, to the Company’s knowledge, there are no facts or circumstances that would reasonably be expected to give rise to material liability of the Company, the Subsidiaries or the Managed Practice under any Health Care Laws. Except as set forth in the SEC Reports, none of the Company, any of its Subsidiaries or the Managed Practice 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 Subsidiaries, the Managed Practice or any of its respective employees, officers or directors, nor to the Company’s knowledge, any of its agents, has been excluded, suspended or debarred from participation in any Program or human clinical research or, to the knowledge of the Company, 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 Company’s, the Subsidiaries’ and the Managed Practice’s compliance therewith included in the SEC Reports fairly summarize the matters therein described.

Compliance with Healthcare Laws and Regulations. Except as disclosed in the SEC ReportsReports or on Schedule 3.1(kk)(i), the Company, Company and the Subsidiaries, the Managed Practice Subsidiary and, to the Company’s knowledgeKnowledge, 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 SubsidiariesSubsidiary, or any of their products or activities, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. Section § 1320a-7a), the civil False Claims Act (31 U.S.C. Section § 3729 et seq.), the criminal False Claims Law (42 U.S.C. Section § 1320a-7b(a)), the Xxxxx law (42 U.S.C. Section § 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. Section § 1320d et seq.) as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section § 17921 et seq.) (“HIPAA”), all criminal laws relating to healthcare fraud and abuse, including but not limited to 18 U.S.C. sections §§ 286 and 287, the healthcare fraud criminal provisions under HIPAA, the exclusion laws (42 U.S.C. Section § 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section § 301 et seq.), the Controlled Substances Act (21 U.S.C. Section § 801 et seq.), the Public Health Service Act (42 U.S.C. Section § 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section § 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), TRICARE (10 U.S.C. Sections § 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 (including diagnostic products and laboratory developed tests)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 Subsidiaries, the Managed Practice Subsidiary or any of its their respective officers, directors, employees or, to the Company’s knowledgeKnowledge, 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 ReportsReports or on Schedule 3.1(kk)(ii), none of the Company, any of the Subsidiaries Company or the Managed Practice Subsidiary has received any notification, correspondence or any other written or, to the Company’s knowledgeKnowledge, 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, HHS’s 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, the Subsidiaries Company or the Managed Practice 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, its Subsidiaries Company or the Managed PracticeSubsidiary. Except as disclosed in the SEC ReportsReports or on Schedule 3.1(k)(iii), to the Company’s knowledgeKnowledge, there are no facts or circumstances that would reasonably be expected to give rise to material liability of the Company, the Subsidiaries Company or the Managed Practice Subsidiary under any Health Care Laws. Except as set forth in the SEC ReportsReports or on Schedule 3.1(k)(iv), none of neither the Company, any of Company nor its Subsidiaries or the Managed Practice 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 Subsidiaries, the Managed Practice Subsidiary or any of its respective employees, officers or directors, nor to the Company’s knowledgeKnowledge, any of its agents, has been excluded, suspended or debarred from participation in any Program or human clinical research or, to the knowledge of the Company’s 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 Company’s, the Subsidiaries’ ’s and the Managed PracticeSubsidiary’s compliance therewith included in the SEC Reports fairly summarize the matters therein described.

Compliance with Healthcare Laws and Regulations. Except as disclosed in the SEC Reports, the Company, Company and the Subsidiaries, the Managed Practice Subsidiary and, to the Company’s knowledgeKnowledge, 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 SubsidiariesSubsidiary, or any of their products or activities, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. Section § 1320a-7a), the civil False Claims Act (31 U.S.C. Section § 3729 et seq.), the criminal False Claims Law (42 U.S.C. Section § 1320a-7b(a)), the Xxxxx law (42 U.S.C. Section § 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. Section § 1320d et seq.) as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section § 17921 et seq.) (“HIPAA”), all criminal laws relating to healthcare fraud and abuse, including but not limited to 18 U.S.C. sections §§ 286 and 287, the healthcare fraud criminal provisions under HIPAA, the exclusion laws (42 U.S.C. Section § 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section § 301 et seq.), the Controlled Substances Act (21 U.S.C. Section § 801 et seq.), the Public Health Service Act (42 U.S.C. Section § 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section § 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), TRICARE (10 U.S.C. Sections § 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 (including diagnostic products and laboratory developed tests)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 Subsidiaries, the Managed Practice Subsidiary or any of its their respective officers, directors, employees or, to the Company’s knowledgeKnowledge, 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, any of the Subsidiaries Company or the Managed Practice Subsidiary has received any notification, correspondence or any other written or, to the Company’s knowledgeKnowledge, 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, HHS’s 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, the Subsidiaries Company or the Managed Practice 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, its Subsidiaries Company or the Managed PracticeSubsidiary. Except as disclosed in the SEC Reports, to the Company’s knowledgeKnowledge, there are no facts or circumstances that would reasonably be expected to give rise to material liability of the Company, the Subsidiaries Company or the Managed Practice Subsidiary under any Health Care Laws. Except as set forth in the SEC Reports, none of neither the Company, any of Company nor its Subsidiaries or the Managed Practice 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 Subsidiaries, the Managed Practice Subsidiary or any of its respective employees, officers or directors, nor to the Company’s knowledgeKnowledge, any of its agents, has been excluded, suspended or debarred from participation in any Program or human clinical research or, to the knowledge of the Company’s 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 Company’s, the Subsidiaries’ ’s and the Managed PracticeSubsidiary’s compliance therewith included in the SEC Reports fairly summarize the matters therein described.