Common use of Healthcare Regulatory Compliance Clause in Contracts

Healthcare Regulatory Compliance. Each of the Company and its Subsidiary is, and at all times has been, in compliance in all material respects with all Health Care Laws to the extent applicable to the Company or its business. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286, 287 and 1349, the health care fraud criminal provisions under HIPAA (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions law (42 U.S.C. Section 1320a-7), and laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the HITECH Act (42 U.S.C. Section 17921 et seq.); (iv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; (vi) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company; and (vii) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. The Company, its Subsidiary and each of their officers, directors, employees and, to the knowledge of the Company, their agents have not engaged in activities which are, as applicable, cause for liability under a Health Care Law. Neither the Company nor its Subsidiary have 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 violation of any Health Care Laws nor, to the Company’s Knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. Each of the Company and its Subsidiary has filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions, and supplements or amendments as required by any 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). Neither the Company, its Subsidiary nor their employees, officers, directors, or, to the knowledge of the Company, their agents is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority related to activities conducted by or on behalf of the Company or its Subsidiary. Additionally, neither the Company, its Subsidiary nor their employees, officers, directors, or, to the knowledge of the Company, their agents has been excluded, suspended or debarred from participation in any U.S. federal health care 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.

Healthcare Regulatory Compliance. Each To the extent required in connection with their respective businesses, each of the Company and its Subsidiary issubsidiaries 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 at all times has been, the Company and each of its subsidiaries reasonably believes that it is in compliance in all material respects with all Health Care Laws to the extent applicable to 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 or and each of its business. For purposes of this Agreement, “Health Care Laws” means: subsidiaries has taken reasonable actions designed to ensure it is in compliance with (i) the Federal Food, Drug, and Cosmetic Act and the Public Health Service False Claims Act, and the regulations promulgated thereunder; 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 and foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), (vi) the U.S. Civil False Claims Act federal health care program false statement law (31 42 U.S.C. Section 3729 et seq.§ 1320a-7b(a)), (vii) the criminal False Statements Civil Monetary Penalties Law (42 U.S.C. Section 1320a-7b(a)§ 1320a-7a), 18 (viii) the exclusion laws (42 U.S.C. Sections 286§ 1320a-7), 287 and 1349, (ix) the health care fraud criminal provisions under HIPAA the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section §§ 1320d et seq.), (x) the civil monetary penalties law Program Fraud Civil Remedies Act (42 31 U.S.C. Section 1320a-7a§ 3801-3812), (xi) the exclusions law Health Care Fraud statute, 18 U.S.C. § 1347, (42 U.S.C. Section 1320a-7)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 Insurance Portability and laws governing government funded or sponsored healthcare programs; (iii) HIPAAAccountability Act of 1996, as amended by the HITECH Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section §§ 17921 et seq.); , the regulations promulgated under both laws, and any applicable state law counterpart thereof or other law or regulation the purpose of which is to protect the data and/or privacy of individuals and their health information or medical records, (ivxiv) applicable provisions of the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; , and the regulations promulgated thereunder, (vxv) licensurelaws and regulations pertaining to licensure of health care providers, and (xvi) quality, safety and accreditation requirements under applicable federal, state, state or local or foreign laws or regulatory bodies; (vi) all other local, state, federal, national, supranational and foreign laws, relating each as applicable to the regulation Company and each subsidiary; the Company and each subsidiary has taken reasonable actions designed to ensure that each subsidiary does not allow any individual with an ownership or control interest (as defined in 42 U.S.C. § 1320a-3(a)(3)) in the Company or any subsidiary or any officer, director or managing employee (as defined in 42 U.S.C. § 1320a-5(b)) of the CompanyCompany or any subsidiary who would be a person excluded from participation in any federal health care program (as defined in 42 U.S.C. § 1320a-7b(f)) as described in 42 U.S.C. § 1320a-7(b)(8) to participate in any such federal health care program maintained by the Company or any subsidiary; and (vii) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. The Company, its Subsidiary and each of their officers, directors, employees and, to the knowledge of the Company, their agents have not engaged in activities which are, as applicable, cause for liability under a Health Care Law. Neither the Company nor its Subsidiary have 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 violation of any Health Care Laws nor, to the Company’s Knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. Each of the Company and its Subsidiary has filed, maintained subsidiaries have structured their respective business practices in a manner reasonably designed to comply with the federal and state laws regarding physician ownership of (or submitted all material reports, documents, forms, notices, applications, records, claims, submissionsfinancial relationship with), and supplements the referral to entities providing, healthcare related goods or amendments as required by any Health Care Lawsservices, and all such reportslaws requiring disclosure of financial interests held by physicians in entities to which they may refer patients for the provisions of health care related goods and services, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed Company reasonably believes that it is in compliance in all material respects (or were corrected or supplemented by a subsequent submission)with such laws. Neither the Company, its Subsidiary nor their employees, officers, directors, or, to the knowledge None of the Company, their agents Company or any of its subsidiaries is a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, orders or similar agreements with or imposed by any governmental or regulatory authority related authority, or has any reporting obligations, plan of correction or other remedial measures entered into pursuant to activities conducted by any such agreement entered into with, or on behalf such decree or order issued by, any such governmental or regulatory authority. None of the Company or any of its Subsidiary. Additionally, neither the Company, its Subsidiary subsidiaries nor any of their respective employees, officers, officers or directors, or, to the knowledge of the CompanyCompany or any of its subsidiaries, their agents is listed as or has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the CompanyCompany or any of its subsidiaries, is subject to a governmental inquiry, investigation, proceeding, proceeding or other similar action that could reasonably be expected to result in debarment, suspension, suspension or exclusion.

Healthcare Regulatory Compliance. Each of Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company and its Subsidiary issubsidiaries are, and at all times has for the past three years have been, in compliance in all material respects with all applicable Health Care Laws to the extent applicable to the Company or its businessLaws. For purposes of this Agreement, The term “Health Care Laws” means: means (i) the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, and the regulations promulgated thereunder; (ii) all applicable federal, state, state and local and foreign health care anti-kickback, self-referral, false claim, fraud and abuse lawslaws and regulations, including, without limitation, including the U.S. Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Civil Xxxxx Law (42 U.S.C. § 1395nn), the federal civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal False Statements Law Claims Act (42 U.S.C. Section § 1320a-7b(a)), 18 U.S.C. Sections 286, 287 and 1349, the health care fraud criminal provisions under HIPAA exclusions laws (42 U.S.C. Section 1320d et seq.§ 1320a-7), the civil monetary penalties law (42 U.S.C. Section § 1320a-7a), 18 U.S.C. §§ 286 and 287 and the exclusions law health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320a-7“HIPAA”), and laws governing government funded or sponsored healthcare programs; (ii) the Medicare Statute (Title XVIII of the Social Security Act); (iii) HIPAA, as amended by the HITECH Act Medicaid Statute (42 Title XIX of the Social Security Act) and state supplemental payment program requirements; (iv) the TRICARE Statute (10 U.S.C. Section 17921 § 1071 et seq.); (iv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety HIPAA privacy and accreditation security requirements under applicable federal, state, local or foreign laws or regulatory bodiesset forth at 45 CFR Parts 160–164; (vi) all other local, state, federal, national, supranational the Emergency Medical Treatment and foreign laws, relating to the regulation of the CompanyLabor Act (42 U.S.C. §1395dd); and (vii) the directives Clinical Laboratory Improvement Amendments (42 U.S.C. 263a et seq.) and laws related to the operation of clinical laboratories; (viii) all federal, state and local health care laws and regulations promulgated pursuant relating to such statutes licensure, accreditation and credentialing of healthcare professionals and facilities, quality and safety, scope of practice and supervision, corporate practice of medicine and other licensed healthcare professionals and professional fee-splitting; (ix) all federal, state and local health care laws and regulations relating to the billing, coding, reimbursement or submission of claims or collection of accounts receivable, copayments, or deductibles or refund of overpayments and the preparation and submission of cost reports; (x) any state laws and regulations related to the ordering, dispensing, and diversion of controlled substances, including 21 U.S.C. § 801, et seq. (known as the “Controlled Substances Act”); and (xi) in each case, as amended, and all applicable implementing regulations, rules, ordinances and governmental orders related to any of the foregoing. Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, in the past three years, neither the Company nor its subsidiaries has received written notice of any Action from any court, arbitrator, governmental or regulatory authority of any non-U.S. counterpart thereof. The Companycompliance or violation of any Health Care Laws, its Subsidiary and each of their officers, directors, employees and, to the knowledge of the Company’s knowledge, their agents have not engaged in activities which are, as applicable, cause for liability under a Health Care Lawno such Action is threatened. Neither the Company nor its Subsidiary have received written notice of subsidiaries is a party or has any claimongoing reporting obligations pursuant to any corporate integrity agreements, actiondeferred prosecution agreements, suitmonitoring agreements, proceeding, hearing, enforcement, investigation, arbitration consent decrees or other action from settlement orders with or imposed by any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s Knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. Each of the Company and its Subsidiary has filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions, and supplements or amendments as required by any 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)authority. Neither the Company, its Subsidiary subsidiaries nor any of their employees, officers, directors, respective directors or officers or, to the knowledge of the Company, their agents is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, employees or similar agreements with or imposed by any governmental or regulatory authority related to activities conducted by or on behalf of the Company or its Subsidiary. Additionally, neither the Company, its Subsidiary nor their employees, officers, directors, or, to the knowledge of the Company, their agents has been excluded, suspended or debarred from from, or is otherwise ineligible for participation in in, any U.S. “federal health care program or human clinical research or, to program” as defined in 42 U.S.C. § 1320a-7b(f) (the knowledge “Federal Health Care Programs”). Neither the Company nor its subsidiaries has received written notice of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action any Action that could would reasonably be expected to result in debarment, suspension, revocation, termination or exclusionexclusion of the Company or its subsidiaries from a Federal Health Care Program.