Healthcare Regulatory Compliance. (a) The Company and each Company Subsidiary are, and at all times since January 1, 2020 have been, in material compliance with all applicable Healthcare Laws. As of the date of this Agreement, there is no civil, criminal, administrative, or other action, subpoena, suit, demand, claim, hearing, Proceeding, written notice or demand pending, received by or, to the Knowledge of the Company, threatened orally or in writing against the Company or any Company Subsidiary related to such Healthcare Laws.
Healthcare Regulatory Compliance. (a) To the knowledge of the Credit Parties and their Subsidiaries, none of the Credit Parties, their Subsidiaries and their other Affiliates, nor any officer, director, managing employee or agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
Healthcare Regulatory Compliance. (a) Neither the Company, nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(2)) of the Company, is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Entity concerning compliance with Federal Health Care Program Laws.
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 an...
Healthcare Regulatory Compliance. To the extent required in connection with their respective businesses, each of the Company and its subsidiaries has the requisite provider number or other authorization to bxxx the Medicare and Medicaid programs in the state or states in which such entity operates; none of the Company or its subsidiaries is subject to any pending, or, to the Company or its subsidiaries’ knowledge, threatened or contemplated action which could reasonably be expected to result either in revocation of any such provider number or other authorization or in the Company’s or any subsidiary’s exclusion from any Medicare or Medicaid health care programs or suspension or debarment by a governmental or regulatory authority; the Company’s and each subsidiary’s business practices have been structured in a manner reasonably designed to comply with the federal or state laws and regulations governing federal health care programs, including, without limitation, Sections 1320a-7a and 1320a-7b of Title 42 of the United States Code, and the Company and each of its subsidiaries reasonably believes that it is in compliance in all material respects with the health care laws set forth in (i) through (xvi) below, except as set forth in or contemplated in the Pricing Disclosure Package and the Prospectus; the Company and each of its subsidiaries has taken reasonable actions designed to ensure it is in compliance with (i) the False Claims Act, 31 U.S.C. Sections 3729-3733, (ii) the “Sxxxx” law, 42 U.S.C. § 1000xx, (xxx) the Federal Criminal False Claims Act, 18 U.S.C. § 286 and 287, (iv) the False Statements Relating to Health Care Mxxxxxx xxxxxxx, 00 X.X.X. § 0000, (x) all applicable U.S. federal, state, and local health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), (vi) the federal health care program false statement law (42 U.S.C. § 1320a-7b(a)), (vii) the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), (viii) the exclusion laws (42 U.S.C. § 1320a-7), (ix) the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §§ 1320d et seq.), (x) the Program Fraud Civil Remedies Act (31 U.S.C. § 3801-3812), (xi) the Health Care Fraud statute, 18 U.S.C. § 1347, (xiii) applicable Medicare (Title XVIII of the Social Security Act) and Medicaid (Title XIX of the Social Security Act) laws, (xiii) the Administrative Simplification provisions of the Health Insuranc...
Healthcare Regulatory Compliance. The Company (i) is and since July 1, 2017, has been in compliance with 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)), and the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, the regulations promulgated pursuant to such laws, and comparable state laws (collectively, the “Applicable Laws”), except for such non-compliance as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; (ii) has not received any written notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting non-compliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), except for such non-compliance as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; (iii) possesses all material Authorizations and such Authorizations are valid and in full force and effect and are not in violation of any term of any such Authorizations, except for such violations as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; (iv) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product, operation or activity is in material violation of any Applicable Laws or Authorizations nor, to the Company’s Knowledge, has any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action been threatened; (v) has not received written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take action to materially limit, suspend, materially modify or revoke any material Authorizations nor, to the Company’s Knowledge, has any such limitation, suspension, material modification or revocation been threatened; (vi) has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable ...
Healthcare Regulatory Compliance. (a) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and the Company Subsidiaries (taken as a whole), since January 1, 2020, the Company and each Company Subsidiary has been and, from January 1, 2020 through the date hereof, to the Company’s Knowledge, all Representatives (when acting on behalf of the Company or any Company Subsidiary) and suppliers (to the extent pertaining to the Company or any Company Subsidiary or any product or service provided to the Company or any Company Subsidiary), have been, in compliance with all applicable Healthcare Laws. Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and the Company Subsidiaries (taken as a whole), as of the date of this Agreement, there is no civil, criminal, administrative, or other action, subpoena, suit, demand, claim, hearing, Proceeding, written notice or demand pending, received by or, to the Knowledge of the Company, threatened against the Company or any Company Subsidiary related to such Healthcare Laws.
Healthcare Regulatory Compliance. (a) Except as set forth on Section 4.20(a) of the Company Disclosure Schedule, there is no Action or Proceeding pending or, to the Knowledge of the Company, threatened against any of the Companies or any of their respective officers, managers, directors (or Persons performing similar functions), agents or employees, and no Company nor any of their respective Agents is involved in or subject to, directly or indirectly, any investigation by or with any Government Entity relating to any of the Permits, Governmental Healthcare Programs (including but not limited to, Medicare or Medicaid) or any state-sponsored reimbursement program (“State Program”), provider agreement or other approval by a Government Entity required, or alleged by such Government Entity to be required, under any Healthcare Laws for the operation of the Business or the Companies’ proposed business activities.
Healthcare Regulatory Compliance. (a) Parent and its subsidiaries is, and at all times since January 1, 2021 has been, in compliance in all material respects with all applicable Healthcare Laws and, as of the date of this Agreement, there is no Action pending, received by or threatened orally or in writing against Parent or its subsidiaries related to such Healthcare Laws.
Healthcare Regulatory Compliance. Agent shall have reviewed the results of, and found such results acceptable in its sole discretion, a healthcare regulatory compliance audit.
