Common use of Compliance with Healthcare Laws Clause in Contracts

Compliance with Healthcare Laws. Except as would not reasonably be expected to have a Material Adverse Effect, the Company is conducting its business in compliance with all applicable health care laws, rules, and regulations of each jurisdiction in which it conducts its business (collectively, the “Health Care Laws”), including, without limitation, (A) the Federal Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.), and the rules and regulations promulgated thereunder (as amended, collectively, the “FFDCA”), (B) all applicable federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), the Xxxxx Law (42 U.S.C. §1395nn), the civil False Claims Act (31 U.S.C. § 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes, (C) the administrative simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (18 U.S.C. §§669, 1035, 1347 and 1518; 42 U.S.C. §1320d et seq.) as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and the regulations promulgated thereunder, (D) the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (42 U.S.C. §1395w-101 et seq.) and the regulations promulgated thereunder, (E) the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, (F) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder, and (G) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder, each of such applicable laws, rules and regulations as may be amended from time to time.

Compliance with Healthcare Laws. Except The Company is, and has been, in compliance with all applicable Health Care Laws, and has not engaged in activities which are, as applicable, cause for false claims liability or civil penalties, except where such noncompliance, false claims liability or civil penalties would not reasonably be expected to have to, singly or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, the Company is conducting its business in compliance with all applicable health care laws, rules, and regulations of each jurisdiction in which it conducts its business (collectively, the “Health Care Laws”)” means all health care laws applicable to the Company, including, without limitation, (A) but not limited to: the Federal Food, Drug Drug, and Cosmetic Act (21 U.S.C. §§ Section 301 et seq.), and the rules and regulations promulgated thereunder (as amended, collectively, the “FFDCA”), (B) all applicable federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), the Xxxxx Civil Monetary Penalties Law (42 U.S.C. §1395nn§ 1320a-7a), the civil Civil False Claims Act (31 U.S.C. § Section 3729 et seq.), the administrative criminal False Claims Law (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 1320a-7 286 and 1320a-7a of Title 42 of the United States Code 287, and the regulations promulgated pursuant to such statutes, (C) health care fraud criminal provisions under the administrative simplification provisions of the U.S. Health Insurance Portability and Accountability Act of 1996 (18 U.S.C. §§669, 1035, 1347 and 1518; “HIPAA”) (42 U.S.C. §Section 1320d et seq.) ), the exclusion laws (42 U.S.C. § 1320a-7), Basic Health and Human Services Policy for Protection of Human Research Subjects “Common Rule” as codified and enforced by the Department of Health and Human Services in 45 C.F.R. part 46 and enforced by FDA under 21 C.F.R. part 50, Laboratory Animal Welfare Act of 1966, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (42 U.S.C. Section 17921 et seq.) any and all other applicable comparable local, state, federal, national, supranational and foreign health care laws and the regulations promulgated thereunder, (D) the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (42 U.S.C. §1395w-101 et seq.) and the regulations promulgated thereunder, (E) the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, (F) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder, and (G) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunderpursuant to such laws, each of such applicable laws, rules and regulations as may be amended from time to time; for the avoidance of doubt, Health Care Laws excludes any U.S. federal laws, statutes, codes, ordinances, decrees, rules or regulations which apply to the production, trafficking, distribution, processing, extraction, sale and/or possession of cannabis, marijuana, psilocybin or related substances, products or synthetic compounds containing or related to same, including, but not limited to, the prohibition on drug trafficking under 21 U.S.C. §84l(a). The Company 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 Health Care Laws, and, to the knowledge of the Company, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company has not received any written notice of adverse filing, warning letter, untitled letter or other correspondence or notice from any Health Regulatory Agencies, or any court or arbitrator, alleging or asserting material noncompliance with the Health Care Laws. The Company is not a party to and has no 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. Additionally, neither the Company, nor, to the knowledge of the Company, any of its employees, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human research study or trial 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.

Compliance with Healthcare Laws. Except as would not reasonably be expected to have a Material Adverse Effect, each of the Company and its subsidiaries is conducting its business in compliance with all applicable health care laws, rules, regulations and regulations policies of each jurisdiction in which it conducts its business (collectively, the “Health Care Laws”)business, including, without limitation, (A) the Federal Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.), and the rules and regulations promulgated thereunder (as amended, collectively, the “FFDCA”), (B) all applicable federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), the Xxxxx Law (42 U.S.C. §1395nn), the civil False Claims Act (31 U.S.C. § 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes, (C) the administrative simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (18 U.S.C. §§669, 1035, 1347 and 1518; 42 U.S.C. §1320d et seq.) as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and the regulations promulgated thereunder, (D) the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (42 U.S.C. §1395w-101 et seq.) and the regulations promulgated thereunder, (E) the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, (F) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder, and (G) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder, (H) all statutes, rules or regulations applicable to the ownership, testing, development, manufacture, quality, safety, accreditation, packaging, use, distribution, labeling, promotion, sale, offer for sale, import, export or disposal of any product manufactured or distributed by the Company and (I) any and all other federal, state or foreign health care laws and regulations applicable to the business of the Company as currently conducted by it as described in the Registration Statement, General Disclosure Package and the Prospectus, each of such applicable laws, rules and regulations (A) through (I) as may be amended from time to timetime (collectively, the “Health Care Laws”). Except as would not reasonably be expected to have a Material Adverse Effect, each of the Company and its subsidiaries has filed, maintained and obtained all notices, reports, documents, forms, notifications, submissions, supplements, amendments or other information required to be filed under the Health Care Laws, and all such notices were complete and correct on the date filed, or have been subsequently corrected or supplemented.

Compliance with Healthcare Laws. Except as would not reasonably be expected For purposes of this Agreement, “Healthcare Laws” means all healthcare laws applicable to have a Material Adverse Effect, the Company is conducting its business in compliance with all applicable health care laws, rules, and regulations of each jurisdiction in which it conducts its business (collectively, the “Health Care Laws”)Company, including, without limitation, (A) but not limited to: the Federal Food, Drug Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.), and the rules and regulations promulgated thereunder (as amended, collectively, the “FFDCA”), (B) all applicable federal and state fraud and abuse laws, including, without limitation, the federal health care program Anti-Kickback Statute (42 U.S.C. § 1320a-7(b1320a-7b(b)), the Xxxxx Civil Monetary Penalties Law (42 U.S.C. §1395nn§ 1320a-7a), the civil Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the Civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the administrative criminal False Claims Law (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 1320a-7 286 and 1320a-7a of Title 42 of the United States Code 287, and the regulations promulgated pursuant to such statutes, (C) health care fraud criminal provisions under the administrative simplification provisions of the U.S. Health Insurance Portability and Accountability Act of 1996 (18 U.S.C. §§669, 1035, 1347 and 1518; “HIPAA”) (42 U.S.C. §Section 1320d et seq.) ), the exclusion laws (42 U.S.C. § 1320a-7), privacy and security regulations promulgated under HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and the regulations promulgated thereunder, (D) the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (42 U.S.C. §1395w-101 Section 17921 et seq.) and the regulations promulgated thereunder), (E) the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, (F) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder), and (G) Medicaid (Title XIX of the Social Security Act) ), other similar state, local, federal or foreign healthcare laws and the regulations promulgated thereunderpursuant to such laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820 and all other laws and regulations applicable to ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of the Company’s products, each of such applicable laws, rules and regulations as may be amended from time to time. Except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, the Company is and at all times has been in compliance with all Health Care Laws and Company 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 health care program or federal health care program. The Company has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting noncompliance with (x) any Health Care Laws or (y) any Governmental Licenses required by any such Health Care Laws. Except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, the Company has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Governmental Licenses and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were materially corrected or supplemented by a subsequent submission). Except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, the Company 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 a violation of any Healthcare Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company is not a party to and has no 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. Additionally, neither the Company nor any of its employees, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program, human research study, clinical trial or clinical registry or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that would reasonably be expected to result in debarment, suspension, or exclusion. The manufacture of the Company’s products by or on behalf of the Company is being conducted in compliance in all respects with all applicable Healthcare Laws, except where such noncompliance would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect.

Compliance with Healthcare Laws. Except as would not reasonably be expected to The Company and its subsidiaries are, and at all times have a Material Adverse Effectbeen, the Company is conducting its business in material compliance with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules, and regulations of each jurisdiction in which it conducts its business (collectively, the “Health Care Laws”), including, without limitation, ” means: (Ai) the Federal Food, Drug Drug, and Cosmetic Act (21 U.S.C. §§ Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the rules and regulations promulgated thereunder thereunder; (as amended, collectively, the “FFDCA”), (Bii) all applicable federal federal, state, local and state foreign health care fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), the Xxxxx Law (42 U.S.C. §1395nn), the civil Civil False Claims Act (31 U.S.C. § Section 3729 et seq.), the administrative False Claims Law criminal false statements law (42 U.S.C. § Section 1320a-7b(a)), 18 U.S.C. Sections 1320a-7 286 and 1320a-7a of Title 42 of 287, the United States Code and health care fraud criminal provisions under the regulations promulgated pursuant to such statutes, (C) the administrative simplification provisions of the U.S. Health Insurance Portability and Accountability Act of 1996 (18 U.S.C. §§669, 1035, 1347 and 1518; “HIPAA”) (42 U.S.C. §Section 1320d et seq.), the Xxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and the regulations promulgated thereunder, (D) the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (42 U.S.C. §1395w-101 Section 17921 et seq.) and the regulations promulgated thereunder, ); (Eiv) the Patient Protection and Affordable Care ActAct of 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; (Fvi) Medicare (Title XVIII all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Social Security Act) and the regulations promulgated thereunderCompany or its subsidiaries, and (Gvii) Medicaid (Title XIX of the Social Security Act) directives and the regulations promulgated thereunderpursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any of its subsidiaries has received any FDA Form 483, each notice of adverse finding, warning letter, untitled letter or 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 Health Care Laws nor, to the Company’s knowledge, is any such applicable lawsclaim, rules action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and regulations its subsidiaries have filed, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as may 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 or were corrected or supplemented by a subsequent submission, except as would not cause a Material Adverse Effect. Neither the Company nor any subsidiary is a party to any corporate integrity agreement, monitoring agreement, consent decree, settlement order, or similar agreement with or imposed by any governmental or regulatory authority. Additionally, neither the Company, any of its subsidiaries, nor any of its or their respective employees, officers, directors or, to the Company’s knowledge, agents, has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to Company’s knowledge, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be amended from time expected to timeresult in debarment, suspension, or exclusion.

Compliance with Healthcare Laws. Except as would not reasonably be expected to have a Material Adverse Effectdescribed in the Registration Statement and the Prospectus Supplement, the Company is conducting and its business Subsidiaries are and have since July 1, 2019 operated in material compliance with all applicable health care laws, rules, and regulations of each jurisdiction in which it conducts its business (collectively, the “Health Care Laws”), including, without limitation, (Ai) the Federal Food, Drug Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.), ) and the rules Public Health Service Act (42 U.S.C. §§ 201 et seq.); (ii) applicable federal, state, local and regulations promulgated thereunder (as amended, collectively, the “FFDCA”), (B) all applicable federal and state foreign health care related fraud and abuse laws, including, without limitation, the federal health care Anti-Kickback kickback Statute (42 U.S.C. § 1320a-7(b1320a-7b(b)), the Xxxxx Law (42 U.S.C. §1395nn), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the administrative False Claims Law (criminal false claims provisions including 42 U.S.C. § 1320a-7b(a)), Sections 1320a-7 18 U.S.C. §§ 286 and 1320a-7a of Title 42 of 287, the United States Code and health care fraud criminal provisions under the regulations promulgated pursuant to such statutes, (C) the administrative simplification provisions of the U.S. Health Insurance Portability and Accountability Act of 1996 (18 U.S.C. §§669“HIPAA”), 1035, 1347 and 1518; the exclusion law (42 U.S.C. §1320d et seq.§ 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a) and the Patient Protection and Affordable Care Act of 2010 (Pub. Law 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. Law 111-152) (collectively, “ACA”), including without limitation the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h); (iii) the applicable requirements of Titles XVIII (Medicare) and Title XIX (Medicaid) of the Social Security Act; (iv) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and the regulations promulgated thereunder, (D) the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (42 U.S.C. §1395w-101 § 1320d et seq., 42 U.S.C. §§ 17921 et seq.); (v) and the regulations promulgated thereunderpursuant to all such laws; and (vi) other similar local, state, federal, or foreign laws and regulations applicable to the Company’s business (E) collectively, the Patient Protection and Affordable Care Act, as amended by the “Health Care and Education Affordability Reconciliation Act Laws”). Since July 1, 2019, neither the Company nor its Subsidiaries nor any of 2010its officers, (F) Medicare (Title XVIII directors or employees, nor, to the knowledge of the Social Security ActCompany, any of its agents, have been excluded, suspended or debarred from participation in any federal health care program as defined in 42 U.S.C. § 1320a-7b(f) (“Programs”) 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 from the Programs. The Company is not a party to and the regulations promulgated thereunderCompany does not have any ongoing reporting obligations pursuant to, and (G) Medicaid (Title XIX any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of the Social Security Act) and the regulations promulgated thereunder, each of such applicable laws, rules and regulations as may be amended from time to timecorrection or similar agreements with or imposed by a governmental body or agency.

Compliance with Healthcare Laws. Except as would not reasonably be expected to have a Material Adverse EffectChange, the Company is conducting its business in compliance with all applicable health care laws, rules, and regulations of each jurisdiction in which it conducts its business (collectively, the “Health Care Laws”), including, without limitation, (A) the Federal Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.), and the rules and regulations promulgated thereunder (as amended, collectively, the “FFDCA”), (B) all applicable federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), the Xxxxx Law (42 U.S.C. §1395nn), the civil False Claims Act (31 U.S.C. § 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes, (C) the administrative simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (18 U.S.C. §§669, 1035, 1347 and 1518; 42 U.S.C. §1320d et seq.) as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and the regulations promulgated thereunder, (D) the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (42 U.S.C. §1395w-101 et seq.) and the regulations promulgated thereunder, (E) the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, (F) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder, and (G) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder, each of such applicable laws, rules and regulations as may be amended from time to time.

Compliance with Healthcare Laws. Except as would not reasonably be expected to have a Material Adverse Effect, the Company is and each of its subsidiaries are conducting its business their respective businesses in compliance with all applicable health care laws, rules, and regulations of each jurisdiction in which it conducts its they conduct business (collectively, the “Health Care Laws”), including, without limitation, (A) the Federal Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.), the Public Health Service Act (42 U.S.C. § 262) and the rules and regulations promulgated thereunder (as amended, collectively, the “FFDCA”), (B) all applicable federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), the Xxxxx Law (42 U.S.C. §1395nn), the civil False Claims Act (31 U.S.C. § 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes, (C) the administrative simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (18 U.S.C. §§669, 1035, 1347 and 1518; 42 U.S.C. §1320d et seq.) as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and the regulations promulgated thereunder, (D) the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (42 U.S.C. §1395w-101 et seq.) and the regulations promulgated thereunder, (E) the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, (F) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder, and (G) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder, each of such applicable laws, rules and regulations as may be amended from time to time. Neither the Company nor any of its subsidiaries is the subject of any pending or, to the knowledge of the Company, threatened investigation in respect of the Company, its subsidiaries or the Company’s products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. Neither the Company nor or its subsidiaries nor, to the knowledge of the Company, any of the Company’s officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion (A) under 21 U.S.C. Section 335a, or (B) any similar applicable law. As of the date hereof, no claims, actions, proceedings or investigations that would reasonably be expected to result in such a debarment or exclusion are pending against the Company or any of its subsidiaries, or to the knowledge of the Company, any of its officers, employees or agent, or, to the knowledge of the Company, threatened against the Company, its subsidiaries or any of their respective officers, employees or agents.

Compliance with Healthcare Laws. Except as would not reasonably be expected to The Company and its subsidiaries are, and at all relevant times have a Material Adverse Effectbeen, the Company is conducting its business in compliance with all Healthcare Laws (as defined below) in all material respects. For purposes of this Agreement, “Healthcare Laws” means: (i) applicable health care laws, rules, and regulations provisions of each jurisdiction in which it conducts its business (collectively, the “Health Care Laws”), including, without limitation, (A) the Federal Food, Drug Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.), ) and the rules and applicable regulations promulgated thereunder thereunder; (as amended, collectively, the “FFDCA”), (Bii) all applicable federal federal, state, local and state fraud and abuse foreign healthcare laws, including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), the Xxxxx Civil Monetary Penalties Law (42 U.S.C. §1395nn§ 1320a-7a), the federal civil False Claims Act (31 U.S.C. § Section 3729 et seq.), the administrative federal criminal False Claims Law (42 U.S.C. § Section 1320a-7b(a)), 18 U.S.C. Sections 1320a-7 286 and 1320a-7a of 287, the U.S. Physician Payments Sunshine Act (42 U.S.C. Section 1320a-7h), 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 (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C.§ 1320a-7), the exclusion laws (42 U.S.C. § 1320a-7), Medicare (Title 42 XVIII of the United States Code and Social Security Act), Medicaid (Title XIX of the Social Security Act), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. § 263a et seq, each as amended, the regulations promulgated pursuant to such statuteslaws; (iii) HIPAA, (C) the administrative simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (18 U.S.C. §§669, 1035, 1347 and 1518; 42 U.S.C. §1320d et seq.) as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and the regulations promulgated thereunder, (D) the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (42 U.S.C. §1395w-101 Section 17921 et seq.) and the regulations promulgated thereunder, ); (Eiv) the Patient Protection and Affordable Care ActAct of 2010 (Public Law 111-148), as amended by the Health Care and Education Affordability Reconciliation Act of 20102010 (Public Law 111-152), (F) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) licensure, quality, safety and accreditation requirements under applicable state, local or foreign laws or regulatory bodies; and (vi) and any other local, state, federal, national, supranational and foreign laws, government memorandum, opinion letter, or other issuance which imposes legal requirements on the manufacturing, development, testing, labeling, marketing or distribution of diagnostic products, recordkeeping, quality, safety, privacy, security, licensure, accreditation or any other aspect of producing diagnostic products. Neither the Company, any of its subsidiaries, nor to the Company’s knowledge, any of their respective officers, directors, employees or agents have engaged in activities which are, as applicable, cause for liability under a Healthcare Law. Neither the Company nor any of its subsidiaries has received any notification, correspondence or any other written or oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the United States Food and Drug Administration (“FDA”), the Drug Enforcement Administration (“DEA”), the Centers for Medicare & Medicaid Services, the U.S. Department of Justice, or the U.S. Department of Health and Human Services Office of Inspector General, of potential or actual non-compliance by, or liability of, the Company or any of its subsidiaries under any Healthcare Laws nor, to the Company’s knowledge, is any such claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Healthcare 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 (G) Medicaid (Title XIX or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries 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. Additionally, neither the Company, any of its subsidiaries nor, to the knowledge of the Social Security Act) and Company, any of their respective employees, officers, directors, or agents has been excluded, suspended or debarred from participation in any U.S. federal healthcare program or human clinical research or, to the regulations promulgated thereunderknowledge of the Company, each of such applicable lawsis subject to a governmental inquiry, rules and regulations as may investigation, proceeding, or other similar action that would reasonably be amended from time expected to timeresult in debarment, suspension, or exclusion.

Compliance with Healthcare Laws. Except as would not reasonably be expected to have result in a Material Adverse Effect, the Company and each of its Subsidiaries is conducting its business in compliance with all applicable health care laws, rules, and regulations of each jurisdiction in which it conducts its business (collectively, the “Health Care Laws”), including, without limitation, (A) the Federal Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.), and the rules and regulations promulgated thereunder (as amended, collectively, the “FFDCA”), (B) all applicable federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), the Xxxxx Law (42 U.S.C. §1395nn), the civil False Claims Act (31 U.S.C. § 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes, (C) the administrative simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (18 U.S.C. §§669, 1035, 1347 and 1518; 42 U.S.C. §1320d et seq.) as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and the regulations promulgated thereunder, (D) the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (42 U.S.C. §1395w-101 et seq.) and the regulations promulgated thereunder, (E) the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, (F) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder, and (G) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder, each of such applicable laws, rules and regulations as may be amended from time to time.