Common use of Compliance with Health Care Laws Clause in Contracts

Compliance with Health Care Laws. Neither the Company or any subsidiary, nor the Company’s or any subsidiary’s business operations is in violation of any Health Care Laws, except where such violation would not reasonably be expected to result in a Material Adverse Effect. “Health Care Laws” means (i) the Food Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectus, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), 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; (iii) the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191), as amended by the Health Information Technology for Economic and Clinical Health, and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other applicable federal, state, or foreign health care laws or regulations, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contrary, the Company makes no representations or warranties regarding compliance by the Company’s physician customers with applicable laws.

Compliance with Health Care Laws. Neither The Company, its or its subsidiaries’ directors, officers, and to the knowledge of the Company, its or its subsidiaries’ employees and agents, are, and at all times have been, in compliance with all health care laws applicable to the Company or any subsidiaryits product candidates or activities, nor including, without limitation, the Company’s or any subsidiary’s business operations is in violation of any Health Care LawsFederal Food, except where such violation would not reasonably be expected to result in a Material Adverse Effect. “Health Care Laws” means (i) the Food Drug Drug, and Cosmetic Act (the “FDCA”) (21 U.S.C. §§ 301 et seq.); (ii) the federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectus, including, but not limited to, the federal Anti-Kickback kickback Statute (42 U.S.C. § 1320a-7(b1320a-7b(b)), the federal Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil False Claims Act (31 U.S.C. § §§3729 et seq.), all criminal laws relating to health care fraud and abuse, including but not limited to the administrative criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), 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; (iii) health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191“HIPAA”) (42 U.S.C. Section 1320d et seq.), HIPAA, as amended by the Health Information Technology for Economic and Clinical HealthHealth Act (42 U.S.C. §§ 17921 et seq.), and the regulations promulgated thereunderexclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (iv) 42 U.S.C. § 1320a-7a), Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) ), Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b201 et seq.), any similar local, state or federal laws, and the VA Federal Supply Schedule regulations promulgated pursuant to such laws (38 U.S.C. § 8126) collectively, the “Health Care Laws”), except where failure to be so in compliance have not, and would not reasonably be expected to have a Material Adverse Effect. The Company has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or under other correspondence or notice from any state pharmaceutical assistance Regulatory Authority or governmental authority alleging or asserting noncompliance with any Health Care Laws applicable to the Company or its subsidiaries. Neither the Company, nor, to the knowledge of the Company, any of its or its subsidiaries’ employees, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or U.S. Department of Veterans Affairs agreementhuman clinical research or, and any successor government programs; (vii) qualityis subject to a governmental inquiry, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other applicable federalinvestigation, stateproceeding, or foreign health care laws other similar action that could reasonably be expected to result in debarment, suspension, or regulations, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contrary, the Company makes no representations or warranties regarding compliance by the Company’s physician customers with applicable lawsexclusion.

Compliance with Health Care Laws. Neither Without limiting the generality of Section 2(n), neither the Company or nor any subsidiaryof its employees, officers, directors and agents, nor the Company’s or any subsidiary’s of their respective business operations operations, is in violation of any applicable Health Care Laws, except where such violation the failure to be in compliance would not reasonably be expected to not, individually or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means means: (i) the Food Drug Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.)and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) the federal all federal, state, local and state all foreign health care related fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, the federal U.S. Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), the civil U.S. Civil False Claims Act (31 U.S.C. § Section 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; (iii) any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical HealthHealth Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) Medicare (Title XVIII of the Social Security U.S. Controlled Substances Act) and the regulations promulgated thereunder; (v) Medicaid any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to the federal TRICARE statute (Title XIX of 10 U.S.C. §1071 et seq.), the Social Security Act) Veterans Administration drug pricing program (38 U.S.C. Section 8126), and the any regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation standards and requirements of all any applicable state federal, state, local or foreign laws or regulatory bodies; and (viiivii) any and all other applicable federal, state, or foreign health care laws and regulations in any jurisdiction, as well as contractual agreements mandated by such laws. Additionally, neither the Company nor any of its employees, officers, directors, agents or regulationscontractors has been excluded, including for each of (i) through (viii) as may be amended suspended or debarred from time to time. Notwithstanding the foregoing or anything herein participation in any federal health care program or, to the contraryknowledge of Company, is subject to an inquiry, investigation, proceeding, or other similar matter that could subject the Company makes no representations or warranties regarding compliance by the Company’s physician customers with applicable lawsany of its employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Neither the Company or any subsidiaryFor purposes of this Agreement, nor the Company’s or any subsidiary’s business operations is in violation of any Health Care Laws, except where such violation would not reasonably be expected to result in a Material Adverse Effect. “Health Care Laws” means (i) all health care laws applicable to the Food Drug Company, including, but not limited to: the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectus, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), the civil Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the 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; (iii) health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), HIPAA, as amended by the Health Information Technology for Economic and Clinical HealthHealth Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) ), Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements), and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other applicable federal, similar state, local, federal or foreign health care laws and the regulations promulgated pursuant 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 regulationsdisposal of the Company’s products, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding Except as would not, singly or in the foregoing or anything herein aggregate, reasonably be expected to the contraryresult in a Material Adverse Effect, the Company makes no representations (i) is and at all times has been in compliance with all Health Care Laws and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or warranties regarding compliance mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal health care program; and (ii) 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 Health Care Laws, and, to the Company’s physician customers 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 applicable lawsor imposed by any Governmental Entity. Additionally, neither the Company nor any of its employees, officers, directors, or, to the knowledge of the Company, agents, has been excluded, suspended or debarred from participation in any U.S. federal health care program or human research study or clinical trial 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.

Compliance with Health Care Laws. Neither Except as would not, singly or in the Company or any subsidiaryaggregate, nor the Company’s or any subsidiary’s business operations is in violation of any Health Care Laws, except where such violation would not reasonably be expected to result in a Material Adverse EffectEffect or except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, neither the Company, nor the Company’s business operations, is in violation of any Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (iA) the Food Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the all federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), the Xxxxx Law (42 U.S.C. §1395nn and §1395(q)), the Anti-Inducement Law (42 U.S.C. § 1320a-7(b1320a-7a(a)(5)), the civil False Claims Act (31 U.S.C. § 3729 X.X.X. §0000 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), Sections 1320a-7 and 1320a-7a of Title the exclusion laws (42 of U.S.C. § 1320a-7), the United States Code civil monetary penalty laws (42 U.S.C. § 1320a-7a) and the regulations promulgated pursuant to such statutes; , (iiiB) the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191), as amended by ) and the Health Information Technology for Economic and Clinical HealthHealth Act of 2009, and the regulations promulgated thereunderthereunder and comparable state privacy and security laws, (ivC) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; , (vD) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; , (viE) the collection and reporting requirementsFederal Food, Drug, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program Cosmetic Act (42 21 U.S.C. § 1396r-8301 et seq.) and any state supplemental rebate programthe regulations promulgated pursuant thereto, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (viiF) quality, safety and accreditation standards and requirements of all applicable state laws or regulatory bodies; bodies and (viiiG) any and all other applicable federal, state, or foreign health care laws or laws, regulations, including for manual provisions, policies and administrative guidance, each of (iA) through (viiiG) as may be amended from time to time. Notwithstanding Except as would not, singly or in the foregoing aggregate, reasonably be expected to result in a Material Adverse Effect or anything herein to except as disclosed in the contraryRegistration Statement, the General Disclosure Package and the Prospectus, the Company makes has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity alleging that any product, operation or activity is in violation of any applicable Health Care Law or permit and has no representations knowledge that any such Governmental Entity is considering any such claim, litigation, arbitration, action, suit, investigation or warranties regarding compliance by proceeding; and the Company’s physician customers with applicable lawsCompany has not received notice, either verbally or in writing, that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any permits and has no knowledge that any such Governmental Entity is considering such action, except for any of the foregoing that would not reasonably be expected to result in a Material Adverse Effect.

Compliance with Health Care Laws. Neither The Company, its or its subsidiaries’ directors, officers, and to the knowledge of the Company, its or its subsidiaries’ employees and agents, are, and at all times have been, in compliance with all health care laws applicable to the Company or any subsidiaryits product candidates or activities, nor including, without limitation, the Company’s or any subsidiary’s business operations is in violation of any Health Care LawsFederal Food, except where such violation would not reasonably be expected to result in a Material Adverse Effect. “Health Care Laws” means (i) the Food Drug Drug, and Cosmetic Act (the “FDCA”) (21 U.S.C. §§ 301 et seq.); (ii) the federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectus, including, but not limited to, the federal Anti-Kickback kickback Statute (42 U.S.C. § 1320a-7(b1320a-7b(b)), the federal Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil False Claims Act (31 U.S.C. § §§3729 et seq.), all criminal laws relating to health care fraud and abuse, including but not limited to the administrative criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), 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; (iii) health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-19142 U.S.C. Section 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical HealthHealth Act (42 U.S.C. §§ 17921 et seq.), and the regulations promulgated thereunderexclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (iv) 42 U.S.C. § 1320a-7a), Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) ), Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b201 et seq.), any similar local, state or federal laws, and the VA Federal Supply Schedule regulations promulgated pursuant to such laws (38 U.S.C. § 8126) collectively, the “Health Care Laws”), except where failure to be so in compliance have not, and would not reasonably be expected to have a Material Adverse Effect. The Company has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or under other correspondence or notice from any state pharmaceutical assistance Regulatory Authority or governmental authority alleging or asserting noncompliance with any Health Care Laws applicable to the Company or its subsidiaries. Neither the Company, nor, to the knowledge of the Company, any of its or its subsidiaries’ employees, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or U.S. Department of Veterans Affairs agreementhuman clinical research or, and any successor government programs; (vii) qualityis subject to a governmental inquiry, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other applicable federalinvestigation, stateproceeding, or foreign health care laws other similar action that could reasonably be expected to result in debarment, suspension, or regulations, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contrary, the Company makes no representations or warranties regarding compliance by the Company’s physician customers with applicable lawsexclusion.

Compliance with Health Care Laws. Neither the Company or any subsidiary, nor the Company’s or any subsidiary’s business operations is in violation of any Health Care Laws, except where such violation would not reasonably be expected to result in a Material Adverse Effect. “Health Care Laws” means (i) the Food Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectus, including, but not limited to, 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; (iiiii) the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191), as amended by the Health Information Technology for Economic and Clinical Health, ) and the regulations promulgated thereunder, (iviii) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (viv) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (viv) the collection and reporting requirementsMedicare Prescription Drug, Improvement, and the processing Modernization Act of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program 2003 (42 U.S.C. § 1396r-8Pub. L. No. 108-173) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programsregulations promulgated thereunder; (viivi) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viiivii) any and all other applicable federal, state, or foreign health care laws or regulations, including for each of (i) through (viiivii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contrary, the Company makes no representations or warranties regarding compliance by the Company’s physician customers with applicable laws.

Compliance with Health Care Laws. Neither The Company and the Company or any subsidiarySubsidiaries are, nor the Company’s or any subsidiary’s business operations is and since January 1, 2017 have been, in violation of any compliance with all applicable Health Care Laws, Laws except where such violation failure to be in compliance would not reasonably be expected reasonably to result in have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means means: (i) the Food Drug Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.), and the regulations promulgated thereunder; (ii) the federal all applicable federal, state, local and state foreign health care related fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, the federal U.S. Anti-Kickback Statute (42 U.S.C. § 1320a-7(b1320a-7b(b)), the civil U.S. Civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the administrative Federal False Claims Statements Law (42 U.S.C. § 1320a-7b(a)), Sections 1320a-7 all criminal laws relating to health care fraud and 1320a-7a of Title 42 of the United States Code abuse, including but not limited to 18 U.S.C. §§ 286 and 287, and the regulations promulgated pursuant to such statutes; (iii) health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191“HIPAA”) (42 U.S.C. §§ 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical HealthCivil Monetary Penalties Law (42 U.S.C. § 1320a-7a), and the regulations promulgated thereunderexclusion laws (42 U.S.C. § 1320a-7), (iv) the Medicare statute (Title XVIII of the Social Security Act) ), and the regulations promulgated thereunder; (v) Medicaid statute (Title XIX of the Social Security Act) and the regulations promulgated pursuant to such statutes; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder; (viiv) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service U.S. Physician Payments Sunshine Act (42 U.S.C. § 256b1320a-7h), and the VA Federal Supply Schedule regulations promulgated thereunder; and (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viiiv) any and all other applicable federal, state, or foreign health care laws or regulations, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein and regulation applicable to the contraryownership, the Company makes no representations testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or warranties regarding compliance disposal of any product under development by the Company. Neither the Company nor the Subsidiaries has 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 alleging that any product operation or activity is in material violation of any Health Care Laws, and, to the Company’s physician customers knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor the Subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with applicable lawsor imposed by any governmental or regulatory authority. Additionally, none of the Company or its Subsidiaries or any of their respective officers or directors or, to the Company’s knowledge, any of their respective employees 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. The Company and the Subsidiaries have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by the 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), except in each case, as would not reasonably be expected to have a Material Adverse Effect.

Compliance with Health Care Laws. Neither the The Company and its subsidiaries are, and have been, in compliance with all applicable Health Care Laws (as defined below), and 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 subsidiaryother state, nor the Company’s federal or any subsidiary’s business operations is in violation of any Health Care Lawsnational health care program, except where such violation noncompliance, false claims liability or civil penalties would not reasonably be expected to to, singly or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means (i) all health care laws applicable to the Food Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the ProspectusCompany, including, but not limited to: the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), the civil Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the 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; (iii) health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), HIPAA, as amended by the Health Information Technology for Economic and Clinical HealthHealth Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) ), Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other applicable federalcomparable local, state, or federal, national, supranational and foreign health care laws or regulationsand the regulations promulgated pursuant to such laws, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding Neither the foregoing Company nor any of its subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or anything herein 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 contraryknowledge of the Company and each of its subsidiaries, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor any of its subsidiaries have received any written notice of adverse filing, warning letter, untitled letter or other correspondence or notice from the FDA, the European Commission, the EMA or any other Health Regulatory Agencies, or any other court or arbitrator, alleging or asserting material noncompliance with the Health Care Laws. Neither the Company makes nor any of its subsidiaries are a party to and has no representations ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or warranties regarding compliance similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor, to the knowledge of the Company’s physician customers with applicable laws, 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 Health Care Laws. Neither Except as described in the Company Registration Statement, the Prospectus and the Pricing Disclosure Package or any subsidiaryexcept as would not, nor individually or in the aggregate, be reasonably expected to have a Material Adverse Effect, each of the Company’s or any subsidiary’s business operations is , its subsidiaries and the JVs is, and at all times has been, in violation of any compliance with all applicable Health Care Laws, except where such violation would and has not reasonably be expected to result engaged in a Material Adverse Effectactivities 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. For purposes of this Agreement, “Health Care Laws” means all Applicable Laws of any Governmental Entity pertaining to health care regulatory matters applicable to the operations of the Company, its subsidiaries or its JVs, including (i) the Food Drug federal, state and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the federal and state local health care related fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, state corporate practice of medicine laws and regulations, state professional fee-splitting laws and regulations, state workers’ compensation laws and regulations, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), the civil Sxxxx Law (42 U.S.C. Section 1395nn), the 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 health care fraud criminal provisions under HIPAA (as defined below), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), any applicable state fraud and abuse prohibitions, including those that apply to all payors (governmental, commercial insurance and self-payors), each as amended, and the implementing rules and regulations promulgated pursuant to such statutes; (ii) Medicare (Title XVIII of the Social Security Act); (iii) Medicaid (Title XIX of the Social Security Act), and the regulations promulgated thereunder; (iv) (a) the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191)1996, 42 U.S.C. §§ 1320d-1329d-8, as amended by the Health Information Technology for Economic and Clinical HealthHealth Act, and the regulations promulgated thereunder, (iv) Medicare (enacted as Title XVIII XIII of the Social American Recovery and Reinvestment Act of 2009, Public Law 111-5 (“HIPAA”); (b) all applicable implementing laws and regulations; and (c) any similar state and local Applicable Laws regarding data protection, data processing, data privacy, data security and/or the collection, use, storage, disclosure or cross-border transfer of personal data and information, including protected health information (collectively, including HIPAA, the “Data Privacy and Security Act) and the regulations promulgated thereunderLaws”); (v) Medicaid any state and federal controlled substance and drug diversion laws, including the Federal Controlled Substances Act (Title XIX of the Social Security Act21 U.S.C. § 801, et seq.) and the regulations promulgated thereunder; (vi) the collection and reporting requirementsClinical Laboratory Improvement Amendments of 1988, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs263a et seq.; (vii) qualityany Applicable Law pertaining to or regulating the provision or administration of, safety or payment for, healthcare products and accreditation requirements of all applicable state laws or regulatory bodiesservices (such services include physician and allied professional services and related ancillary services); (viii) and Applicable Law regulating the ownership or operation of a health care facility or business, or assets used in connection therewith, including licensing, certification and/or accreditation requirements; and (ix) any and all other applicable federal, state, or foreign health care laws or and regulations, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein , applicable to the contraryoperations of the Company, its subsidiaries or its JVs. Except as described in the Registration Statement, the Company makes no representations Prospectus and the Pricing Disclosure Package, none of the Company, any subsidiary or warranties regarding compliance by any of the JVs has received written notice from any Governmental Entity of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action alleging that any of the Company, the subsidiaries or the JVs is in material violation of any Health Care Laws, and, to the Company’s physician customers knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Except as described in the Registration Statement, the Prospectus and the Pricing Disclosure Package, none of the Company, any subsidiary or any of the JVs is a party to 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 applicable lawsor imposed by any Governmental Entity. Additionally, none of the Company, its subsidiaries, or the JVs nor any of their respective employees, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or 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 Health Care Laws. Neither the Company or any subsidiarythe Subsidiary, nor their respective officers, directors, employees, agents and contractors (exercising their respective duties on behalf of the Company or the Subsidiary), nor the Company’s or any subsidiarythe Subsidiary’s business operations is operations, is, or at any time has been, in violation of any Health Care Laws, except where such violation would not reasonably be expected to result in a Material Adverse Effect. “Health Care Laws” means shall mean (iA) the Food federal Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 321 et seq.); , and the regulations promulgated thereunder, (iiB) the all federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b§1320a-7b(b)), the civil Xxxxx Law (42 U.S.C. §1395nn), the Civil False Claims Act (31 U.S.C. § 3729 X.X.X. §0000 et seq.), the administrative Administrative False Claims Law (42 U.S.C. § §1320a-7b(a)), the Anti-Inducement Law (42 U.S.C. §1320a-7a(a)(5)), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; , (iiiC) the administrative simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-19142 U.S.C. §§1320d-1320d-8), as amended by the Health Information Technology for Economic regulations promulgated thereunder and Clinical Healthcomparable state laws, (D) the Controlled Substances Act (21 U.S.C. §801 et seq.), (E) Titles XVIII (42 U.S.C. §1395 et seq.) and XIX (42 X.X.X. §0000 et seq.) of the Social Security Act and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (viiF) quality, safety and accreditation standards and requirements of all applicable foreign or state laws or regulatory bodies; , and (viiiG) any and all other applicable federal, state, or foreign health care laws or laws, regulations, including for manual provisions, policies and administrative guidance, each of (iA) through (viiiF) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contrary, the Company makes no representations or warranties regarding compliance by the Company’s physician customers with applicable laws.

Compliance with Health Care Laws. Neither The Company and the Company or any subsidiarySubsidiaries are, nor the Company’s or any subsidiary’s business operations is and since January 1, 2013 have been, in violation of any compliance with all applicable Health Care Laws, Laws except where such violation failure to be in compliance would not reasonably be expected reasonably to result in have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means means: (i) the Food Drug Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.), and the regulations promulgated thereunder; (ii) the federal all applicable federal, state, local and state foreign health care related fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, the federal U.S. Anti-Kickback Statute (42 U.S.C. § 1320a-7(b1320a-7b(b)), the civil U.S. Civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the administrative Federal False Claims Statements Law (42 U.S.C. § 1320a-7b(a)), Sections 1320a-7 all criminal laws relating to health care fraud and 1320a-7a of Title 42 of the United States Code abuse, including but not limited to 18 U.S.C. §§ 286 and 287, and the regulations promulgated pursuant to such statutes; (iii) health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191“HIPAA”) (42 U.S.C. §§ 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical HealthCivil Monetary Penalties Law (42 U.S.C. § 1320a-7a), and the regulations promulgated thereunderexclusion laws (42 U.S.C. § 1320a-7), (iv) the Medicare statute (Title XVIII of the Social Security Act) ), and the regulations promulgated thereunder; (v) Medicaid statute (Title XIX of the Social Security Act) and the regulations promulgated pursuant to such statutes; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder; (viiv) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service U.S. Physician Payments Sunshine Act (42 U.S.C. § 256b1320a-7h), and the VA Federal Supply Schedule regulations promulgated thereunder; and (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viiiv) any and all other applicable federal, state, or foreign health care laws or regulations, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein and regulation applicable to the contraryownership, the Company makes no representations testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or warranties regarding compliance disposal of any product under development by the Company. Neither the Company nor the Subsidiaries has 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 alleging that any product operation or activity is in material violation of any Health Care Laws, and, to the Company’s physician customers knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor the Subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with applicable lawsor imposed by any governmental or regulatory authority. Additionally, none of the Company or its Subsidiaries or any of their respective officers or directors or, to the Company’s knowledge, any of their respective employees 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. The Company and the Subsidiaries have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by the 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), except in each case, as would not reasonably be expected to have a Material Adverse Effect.

Compliance with Health Care Laws. Neither Except as would not, individually or in the Company or any subsidiaryaggregate, nor the Company’s or any subsidiary’s business operations is in violation of any Health Care Laws, except where such violation would not reasonably be expected to result in have a Material Adverse Effect, the Company and its subsidiaries are, and since March 1, 2015 have been, in compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the Food Drug Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.)and the regulations promulgated thereunder; (ii) the federal all applicable federal, state, local and state foreign health care fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, the federal U.S. Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), the civil U.S. Civil False Claims Act (31 U.S.C. § Section 3729 et seq.), the administrative criminal False Claims Statements Law (42 U.S.C. § Section 1320a-7b(a)), 18 U.S.C. Sections 1320a-7 286, 287, 1035, 1347, and 1320a-7a of Title 1349 the health care fraud criminal provisions under HIPAA , the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 X.X.X Xxxxxxx 0000-0x), and the laws governing U.S. government funded or sponsored healthcare programs; and (iii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the United States Code Company or its subsidiaries, and (iv) the regulations promulgated pursuant to such statutes; (iii) the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191), as amended by the Health Information Technology for Economic and Clinical Health, and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) statutes and any state supplemental rebate programor non-U.S. counterpart thereof. Neither the Company, Medicare average sales price reporting (42 U.S.C. § 1395w-3a)any of its subsidiaries, nor to the Public knowledge of the Company, nor any of their respective officers, directors, employees or agents have since March 1, 2015 engaged in activities which are, as applicable, cause for liability under a Health Service Act (42 U.S.C. § 256b)Care Law. Since March 1, 2015, neither the VA Federal Supply Schedule (38 U.S.C. § 8126) Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or under other action from any state pharmaceutical assistance program court or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation requirements of all applicable state laws arbitrator or governmental or regulatory bodies; (viii) authority or third party alleging that any and all other applicable federalproduct operation or activity is in material violation of any Health Care Laws nor, state, or foreign health care laws or regulations, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contraryCompany’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company makes no representations and its subsidiaries have filed, maintained or warranties regarding compliance 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 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, since March 1, 2015, neither the Company’s physician customers with applicable laws, any of its subsidiaries nor any of their respective employees, officers, directors, or, to the knowledge of the Company, 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.

Compliance with Health Care Laws. Neither the Company or any subsidiary, nor the Company’s or any subsidiary’s business operations is in violation of any Health Care Laws, except where such violation Except as would not reasonably be expected expected, individually or in the aggregate, to result in a Material Adverse Effect, the Company and its subsidiaries are, and during the last five (5) years have been, in compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the Food Drug Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ Section 301 et seq.), the applicable provisions of the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) the federal all applicable federal, state, local and state foreign health care fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), 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 287, the criminal health care fraud law (18 U.S.C. Section 1347), the civil monetary penalties law (42 of U.S.C. Section 1320a-7a), the United States Code exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and the regulations promulgated pursuant to such statutesapplicable laws governing governmental health care programs; (iii) the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191)HIPAA, as amended by the Health Information Technology for Economic and Clinical Health, and the regulations promulgated thereunder, Health Act (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder42 U.S.C. Section 17921 et seq.); (v) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirementslicensure, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation requirements of all under applicable state federal, state, local or foreign laws or regulatory bodies; and (viiivi) any and all other applicable federallocal, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign health care laws its subsidiaries, and (vii) the regulations promulgated pursuant to such statutes and any state or regulationsnon-U.S. counterpart thereof. In the past five (5) years, including for each neither the Company nor any of (i) through (viii) as its subsidiaries has 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 or may be amended from time to time. Notwithstanding the foregoing or anything herein in material violation of any Health Care Laws nor, to the contraryCompany’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened or contemplated. Except as would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect, the Company makes no representations and its subsidiaries have filed, maintained or warranties regarding compliance 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 nor any of its subsidiaries is a party to any corporate integrity agreement, monitoring agreement, consent decree, settlement order, or similar agreement with or imposed by any Regulatory Agency. Additionally, neither the Company’s physician customers with applicable laws, any of its subsidiaries, nor any of their respective employees, officers, directors, managing employees, owners or, to the knowledge of the Company, agents has been excluded, suspended or debarred from participation in any U.S. governmental 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.

Compliance with Health Care Laws. Neither the The Company or any subsidiary, nor the Company’s or any subsidiary’s business operations is and has been in violation of any compliance with all Health Care LawsLaws (as hereinafter defined), except where such violation instances of non-compliance would not not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means (i) all health care laws applicable to the Food Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the ProspectusCompany, including, but not limited to: the Federal Food, Drug, and Cosmetic Act, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), the civil Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the 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; (iii) health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), HIPAA, as amended by the Health Information Technology for Economic and Clinical HealthHealth Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) ), Medicaid (Title XIX of the Social Security Act) ), and any and all other similar state, local or federal health care laws and the regulations promulgated thereunder; (vi) the collection and reporting requirementspursuant to such laws, and the processing of any applicable rebateincluding, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a)without limitation, the Public Health Service Act (42 U.S.C. § 256b)FDA’s current good manufacturing practice regulations at 21 CFR Part 820, the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other laws and regulations applicable federalto ownership, statetesting, development, manufacture, packaging, processing, use, distribution, storage, import, export or foreign health care laws or regulationsdisposal of the Company’s products, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding The 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, except where such noncompliance, false claims liability or civil penalties would not reasonably be expected to, singly or in the foregoing aggregate, result in a Material Adverse Effect. The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or anything herein other action from any court or arbitrator or governmental or regulatory authority or third party alleging a material violation of any Health Care Laws, and, to the contraryCompany’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, 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, 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 could reasonably be expected to result in debarment, suspension, or exclusion. Except as described in the Registration Statement, the Preliminary Prospectus and the Prospectus or as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company makes no representations has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or warranties regarding compliance 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 the Company’s physician customers with applicable lawsany such Health Care Laws.

Compliance with Health Care Laws. Neither the Company or any subsidiary, nor the Company’s or any subsidiary’s business operations is in violation of any Health Care Laws, except where such violation Except as would not reasonably be expected to result in have 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” means ”), including, without limitation, (iA) the Food Federal Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); , and the rules and regulations promulgated thereunder (iias amended, collectively, the “FFDCA”), (B) the all applicable federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout 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; , (iiiC) the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191)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, Health Act of 2009 and the regulations promulgated thereunder, (ivD) 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 (vG) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing each of any such applicable rebatelaws, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other applicable federal, state, or foreign health care laws or regulations, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contrary, the Company makes no representations or warranties regarding compliance by the Company’s physician customers with applicable laws.

Compliance with Health Care Laws. Neither the The Company or any subsidiaryhas operated in compliance since January 1, nor the Company’s or any subsidiary’s business operations 2017, and currently is in violation of any Health Care Lawscompliance, with all applicable health care laws, rules and regulations (except where such violation failure to operate or non-compliance would not not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect. “Health Care Laws” means ), including, without limitation, (i) the Food Federal Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the federal all applicable federal, state, local and state all applicable foreign health care related fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, the federal Anti-Kickback kickback Statute (42 U.S.C. § 1320a-7(b1320a-7b(b)), the U.S. 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 287, the United States Code and health care fraud criminal provisions under the regulations promulgated pursuant to such statutes; (iii) the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), and the civil monetary penalties law (42 U.S.C. § 1320a-7a); (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health, and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256bSection 17921 et seq.), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (viiiv) quality, safety the regulations promulgated pursuant to such laws; and accreditation requirements of all applicable state laws or regulatory bodies; (viiiv) any and all other applicable federalsimilar local, state, federal, or foreign health care laws or regulations, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contrarycollectively, the “Health Care Laws”). The Company makes no representations has not received written notice or warranties regarding compliance by other correspondence of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action (“Action”) from any court or arbitrator or Governmental Authority alleging that any product operation or activity is in material violation of any Health Care Laws, and, to the Company’s physician customers with applicable lawsknowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company is not a party to and does not have 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, neither the Company, nor to the Company’s knowledge, any of its employees, officers or directors, has been excluded, suspended or debarred from participation in any U.S. state or 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.

Compliance with Health Care Laws. Neither the Company or any subsidiary, nor the Company’s or any subsidiary’s business operations is in violation of any Health Care Laws, except where such violation Except as would not reasonably be expected to result in a Material Adverse EffectChange to the operations of the Company and its subsidiaries as a whole, the Company and its subsidiaries are, and at all times have been, in compliance in all respects with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the Food Drug Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ Section 301 et seq.), and the regulations promulgated thereunder; (ii) the federal all applicable federal, state, local and state foreign health care fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), 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; (iii) the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191“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), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health, and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256bSection 17921 et seq.), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (viiiv) licensure, quality, safety and accreditation requirements of all under applicable state federal, state, local or foreign laws or regulatory bodies; and (viiiv) the directives and regulations promulgated pursuant to such statutes and any and all other applicable federal, statestate or non-U.S. counterpart thereof. Neither the Company or its subsidiaries, or foreign any of its respective officers, directors, employees or, to the knowledge of the Company, agents, have engaged in activities which are, as applicable, cause for Federal civil or criminal false claims liability, or mandatory or permissive exclusion from Medicare, Medicaid, TRICARE, any federal health care laws or regulations, including for each of program (i) through (viiias defined in 42 U.S.C. § 1320a-7b(f)) as may be amended from time to timedescribed in 42 U.S.C. § 1320a-7(b)(8) or any other state or federal healthcare program (collectively, the “Programs”). Notwithstanding Except as otherwise disclosed in the foregoing Registration Statement, the Time of Sale Prospectus and the Prospectus or anything herein as would not result in a Material Adverse Change to the contraryoperations of the Company and its subsidiaries as a whole, neither the Company nor any of its subsidiaries has 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 (“Action”). Except as would not result in a Material Adverse Change to the operations of the Company and its subsidiaries as a whole, the Company makes no representations and its subsidiaries have filed, maintained or warranties regarding compliance submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and, except as would not result in a Material Adverse Change to the operations of the Company and its subsidiaries as a whole, 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). Except as otherwise disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, 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’s physician customers with applicable laws, any of its subsidiaries nor, except as would not result in a Material Adverse Change to the operations of the Company and its subsidiaries as a whole, any of their respective employees, officers, directors, or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or, to the knowledge of the Company, except as otherwise disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, 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 Health Care Laws. Neither Except as would not, singly or in the Company or any subsidiaryaggregate, nor the Company’s or any subsidiary’s business operations is in violation of any Health Care Laws, except where such violation would not reasonably be expected to result in a Material Adverse Effect. “Effect or except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, neither the Company, nor the Company’s business operations, is in violation of any Health Care Laws” . For purposes of this Agreement, "Health Care Laws" means (iA) the Food Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the all federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), the Xxxxx Law (42 U.S.C. §1395nn and §1395(q)), the Anti-Inducement Law (42 U.S.C. § 1320a-7(b1320a-7a(a)(5)), the civil False Claims Act (31 U.S.C. § 3729 X.X.X. §0000 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), Sections 1320a-7 and 1320a-7a of Title the exclusion laws (42 of U.S.C. § 1320a-7), the United States Code civil monetary penalty laws (42 U.S.C. § 1320a-7a) and the regulations promulgated pursuant to such statutes; , (iiiB) the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191), as amended by ) and the Health Information Technology for Economic and Clinical HealthHealth Act of 2009, and the regulations promulgated thereunderthereunder and comparable state privacy and security laws, (ivC) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; , (vD) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; , (viE) the collection and reporting requirementsFederal Food, Drug, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program Cosmetic Act (42 21 U.S.C. § 1396r-8301 et seq.) and any state supplemental rebate programthe regulations promulgated pursuant thereto, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (viiF) quality, safety and accreditation standards and requirements of all applicable state laws or regulatory bodies; bodies and (viiiG) any and all other applicable federal, state, or foreign health care laws or laws, regulations, including for manual 763344-4-33-v0.24 - 10 - 80-40671377 provisions, policies and administrative guidance, each of (iA) through (viiiG) as may be amended from time to time. Notwithstanding Except as would not, singly or in the foregoing aggregate, reasonably be expected to result in a Material Adverse Effect or anything herein to except as disclosed in the contraryRegistration Statement, the General Disclosure Package and the Prospectus, the Company makes has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity alleging that any product, operation or activity is in violation of any applicable Health Care Law or permit and has no representations knowledge that any such Governmental Entity is considering any such claim, litigation, arbitration, action, suit, investigation or warranties regarding compliance by proceeding; and the Company’s physician customers with applicable lawsCompany has not received notice, either verbally or in writing, that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any permits and has no knowledge that any such Governmental Entity is considering such action, except for any of the foregoing that would not reasonably be expected to result in a Material Adverse Effect.

Compliance with Health Care Laws. Neither The Company and its subsidiary is, and during the Company or any subsidiarylast three (3) years, nor the Company’s or any subsidiary’s business operations is has been, in violation of any compliance with all Health Care Laws, except where such violation failure to comply would not be reasonably be expected expected, individually or in the aggregate, to result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means means: (i) the Food Drug Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ Section 301 et seq.) and the Public Health Service Act (42 U.S.C. Section 201 et seq.); (ii) the federal all applicable federal, state, local and state foreign health care fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), 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, 287, 1347 and 1320a-7a of Title 42 of 1349, the United States Code and the regulations promulgated pursuant to such statutes; (iii) health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-19142 U.S.C. Section 1320d et seq.) (“HIPAA”), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health, and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256bSection 17921 et seq.), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (viiiv) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other applicable federalsimilar local, state, or federal, national, supranational and foreign health care laws; and (v) the regulations promulgated pursuant to such laws or regulations, including for each of set forth in subparts (i) through (viiiiv). Except as would not be reasonably expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contraryyears, the Company makes no representations has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or warranties regarding compliance by other action from any court or arbitrator or governmental authority alleging that any product, operation, or activity is in violation of any Health Care Laws nor, to the Company’s physician customers knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. Except as would not be reasonably expected, individually or in the aggregate, to result in a Material Adverse Effect, during the last three (3) years, the Company has filed, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments (“Submissions”) as required by any Health Care Laws, and all such Submissions were accurate on the date filed (or were corrected or supplemented by a subsequent submission). The Company is not a party to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with applicable lawsor imposed by any Governmental Entity. During the last three (3) years, neither the Company nor any of its 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.

Compliance with Health Care Laws. Neither the Company or any subsidiary, nor the Company’s or any subsidiary’s business operations is in violation of any Health Care Laws, except where such violation would not reasonably be expected to result in a Material Adverse Effect. “Health Care Laws” means (i) the Food Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the federal and state fraud and abuse laws referred to generally or specifically Except as described in the Preliminary Prospectus Registration Statement and the Prospectus, includingthe Company: (i) to the extent applicable, but not limited tohas operated and currently operates its business in compliance with applicable provisions of the health care laws, including Title XVIII of the federal Anti-Kickback Statute (Social Security Act, 42 U.S.C. §§ 1320a-7(b1395-1395hhh (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396v (the Medicaid statute); the Federal Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x); the civil False Claims Act (Act, 31 U.S.C. §§ 3729 et seq.), ; the administrative criminal False Claims Law (Act 42 U.S.C. § 1320a-7b(a)); the criminal laws relating to health care fraud and abuse, including 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; (iii) health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996 1996, 42 U.S.C. §§ 1320d et seq., (Pub. L. No. 104-191“HIPAA”); the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a; the Physician Payments Xxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; the exclusion law, 42 U.S.C. § 1320a-7; HIPAA, as amended by the Health Information Technology for Economic and Clinical HealthHealth Act, 42 U.S.C. §§ 17921 et seq.; the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq.; the regulations promulgated thereunderpursuant to such laws; and any similar federal, state and local laws and regulations of any governmental authority including the Regulatory Agencies applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any of the Company’s product candidates, (collectively the “Health Care Laws”) except as would not, singly or in the aggregate, result in a Material Adverse Effect; (ii) 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 non-compliance with (A) any Health Care Laws or (B) or any licenses, approvals, clearances, exemptions, permits, registrations, authorizations, and supplements or amendments thereto required by any such Health Care Laws (“Regulatory Authorizations”); (iii) possesses all Regulatory Authorizations required to conduct its business as currently conducted and such Regulatory Authorizations are valid and in full force and effect and the Company is not in violation in any material respect of any term of any such Regulatory Authorizations; (iv) Medicare has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (Title XVIII “Proceeding”) from any governmental authority including any Regulatory Agency or any other third party alleging a material violation of the Social Security Act) any Health Care Laws or Regulatory Authorizations or limiting, suspending, modifying, or revoking any material Regulatory Authorizations, and the regulations promulgated thereunderhas no knowledge that any governmental authority including any Regulatory Agencies or any other third party is considering any Proceeding; (v) Medicaid 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 Regulatory Authorizations (Title XIX of the Social Security Act“Reports”) and that all such Reports were materially complete and correct on the regulations promulgated thereunder; date filed (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3awere materially corrected or supplemented by a subsequent submission), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) qualityis not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, safety deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental authority including any Regulatory Agencies; and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any along with its employees, officers and all other applicable federaldirectors, statehas not been excluded, suspended or debarred from, or foreign otherwise ineligible for participation in any government health care laws program or regulationshuman clinical research. Any certificate signed by any officer or representative of the Company or any of its subsidiaries and delivered to the Agent or counsel for the Agent in connection with an issuance of Shares shall be deemed a representation and warranty by the Company to the Agent as to the matters covered thereby on the date of such certificate. The Company acknowledges that the Agent and, including for each purposes of (ithe opinions to be delivered pursuant to Section 4(p) through (viiiand Section 5(d) as may be amended from time hereof, counsel to time. Notwithstanding the Company and counsel to the Agent, respectively, will rely upon the accuracy and truthfulness of the foregoing or anything herein representations and hereby consents to the contrary, the Company makes no representations or warranties regarding compliance by the Company’s physician customers with applicable lawssuch reliance.

Compliance with Health Care Laws. Neither Without limiting the generality of clause (xviii) above and except as described in the Prospectus and the Registration Statement and except as would not, singly or in the aggregate, result in a Material Adverse Effect, neither the Company or any subsidiary, nor the Company’s 's or any subsidiary’s 's business operations is in violation of any Health Care Laws. For purposes of this Agreement, except where such violation would not reasonably be expected to result in a Material Adverse Effect. “"Health Care Laws” " means (i) the Food Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the all federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. § §1320a-7(b)), the Xxxxx Law (42 U.S.C. §1395nn and §1395(q)), the civil False Claims Act (31 U.S.C. § 3729 X.X.X. §0000 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; (iiiii) the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191), as amended by the Health Information Technology for Economic and Clinical Health, ) and the regulations promulgated thereunder, (iviii) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (viv) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (viv) the collection and reporting requirementsMedicare Prescription Drug, Improvement, and the processing Modernization Act of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program 2003 (42 U.S.C. § 1396r-8Pub. L. No. 108-173) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programsregulations promulgated thereunder; (viivi) quality, safety and accreditation standards and requirements of all applicable state laws or regulatory bodies; and (viiivii) any and all other applicable federal, state, or foreign health care laws or laws, regulations, including for manual provisions, policies and administrative guidance, each of (i) through (viiivii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contrary, the Company makes no representations or warranties regarding compliance by the Company’s physician customers with applicable laws.

Compliance with Health Care Laws. Neither Except as would not, individually or in the Company or any subsidiaryaggregate, nor the Company’s or any subsidiary’s business operations is in violation of any Health Care Laws, except where such violation would not reasonably be expected to result in have a Material Adverse Effect: the Company is, and has since January 1, 2017 been, in compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the Food Drug Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.)and the regulations promulgated thereunder; (ii) the federal all applicable federal, state, local and state foreign health care fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, the federal U.S. Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), the civil U.S. Civil False Claims Act (31 U.S.C. § Section 3729 et seq.), the administrative criminal False Claims Statements Law (42 U.S.C. § Section 1320a-7b(a)), 18 U.S.C. Sections 1320a-7 286, 287, 1035, 1347, and 1320a-7a 1349, the health care fraud criminal provisions under HIPAA , the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions law (42 U.S.C. Section 1320a-7) and the Physician Payments Sunshine Act (42 U.S.C Section 1320-7h); (iii) the Patient Protection and Affordable Care Act of Title 42 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (iv) licensure and accreditation requirements under applicable federal, state, applicable local or foreign laws or regulatory bodies; (v) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the United States Code Company; and (vi) and the regulations promulgated pursuant to such statutes; (iii) laws. Neither the Health Insurance Portability and Accountability Act Company nor any of 1996 (Pub. L. No. 104-191)its officers, directors, employees nor, to the knowledge of the Company, its agents, have engaged in activities which are, as amended by applicable, cause for liability to the Company under a Health Information Technology for Economic and Clinical HealthCare Law. The Company has not received written notice of any claim, and 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 regulations promulgated thereunder, (iv) Medicare (Title XVIII knowledge of the Social Security Act) and Company, has any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action been threatened. Except as would not, individually or in the regulations promulgated thereunder; (v) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirementsaggregate, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating reasonably be expected to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other applicable federal, state, or foreign health care laws or regulations, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contraryhave a Material Adverse Effect, the Company makes no representations has filed, maintained or warranties regarding compliance submitted all 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 nor any of its employees, officers, directors, or to the knowledge of the Company’s physician customers , any of its agents, is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with applicable lawsor imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its employees, officers, directors, or to the knowledge of the Company, its 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 would reasonably be expected to result in debarment, suspension or exclusion.

Compliance with Health Care Laws. Neither Except as disclosed in the Company SEC Reports, and except as would not, individually or any subsidiaryin the aggregate, nor the Company’s or any subsidiary’s business operations is in violation of any Health Care Laws, except where such violation would not reasonably be expected to result in have a Material Adverse Effect, the Company and, to the Company’s Knowledge, its directors, officers, employees, independent contractors, agents and affiliates are, and at all times have been, in compliance with all applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the Food Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectus, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), 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; (iii) the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191), as amended by the Health Information Technology for Economic and Clinical Health, and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a)FDCA, the Public Health Service Act (42 U.S.C. § 256b), 201 et seq.) and the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programsregulations promulgated thereunder; (viiii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other applicable federal, state, or 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)), all criminal laws or regulationsrelating to health care fraud and abuse, including for each of but not limited to 18 U.S.C. Sections 286, 287 and 1349, the health care fraud criminal provisions under HIPAA, the civil monetary penalties law (i42 U.S.C. Section 1320a-7a), the exclusions law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C Section 1320-7h), and the laws governing U.S. government funded or sponsored healthcare programs; and (iii) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein all other local, state, federal, national, supranational and foreign laws, relating to the contraryregulation of the Company, and (iv) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. 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 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, except where any of the foregoing, if resolved adversely to the Company, would not reasonably be expected to have a Material Adverse Effect. Except as would not, whether individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company makes no representations has filed, maintained or warranties regarding compliance 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 (or were corrected or supplemented by a subsequent submission). The Company is not 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 or body. Additionally, none of the Company, its employees, officers, directors, or, to the Company’s physician customers with applicable lawsKnowledge, independent contractors, affiliates or agents, has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or 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 Health Care Laws. Neither Without limiting the generality of clause (xvii) above and except as described in the Registration Statement, the U.S. Prospectus and the Canadian Prospectus, neither the Company or any its subsidiary, nor the Company’s or any its subsidiary’s business operations is in violation of any Health Care Laws, except where such violation the failure to be in compliance would not reasonably be expected to result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means means: (i) the Food U.S. federal Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.)Act, and the regulations promulgated thereunder; (ii) the federal all U.S. and Canadian federal, state and provincial fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, the U.S. federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b§1320a7b(b)), the U.S. Xxxxx Law (42 U.S.C. §1395nn), the U.S. civil False Claims Act (31 U.S.C. § 3729 X.X.X. §0000 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; (iii) the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191), as amended by the Health Information Technology for Economic and Clinical Health, and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (iv) the U.S. Controlled Substances Act; (v) Medicaid (Title Titles XVIII and XIX of the U.S. Social Security Act) Act and the regulations promulgated thereunder; (vi) the collection and reporting requirementsU.S. Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programspromulgated thereunder; (vii) quality, safety and accreditation standards and requirements of all applicable state and provincial laws or regulatory bodies; and (viii) any and all other applicable federal, state, or foreign health care laws or laws, regulations, including for manual provisions, policies and administrative guidance, each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contrary, the Company makes no representations or warranties regarding compliance by the Company’s physician customers with applicable laws.

Compliance with Health Care Laws. Neither the Company or any subsidiary, nor the Company’s or any subsidiary’s business operations is in violation of any Health Care Laws, except where such violation would not reasonably be expected to result in a Material Adverse Effect. “Health Care Laws” means (i) the Food Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectus, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), the Xxxxx Law (42 U.S.C. § 1395nn and § 1395(q)), 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; (iiiii) the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191), as amended by the Health Information Technology for Economic and Clinical Health, ) and the regulations promulgated thereunder, (iviii) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (viv) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (viv) the collection and reporting requirementsMedicare Prescription Drug, Improvement, and the processing Modernization Act of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program 2003 (42 U.S.C. § 1396r-8Pub. L. No. 108-173) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programsregulations promulgated thereunder; (viivi) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viiivii) any and all other applicable federal, state, or foreign health care laws or regulations, including for each of (i) through (viiivii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contrary, the Company makes no representations or warranties regarding compliance by the Company’s physician customers with applicable laws.

Compliance with Health Care Laws. Neither the The Company or any subsidiary, nor the Company’s or any subsidiary’s business operations has operated and currently is in violation of any Health Care Lawscompliance with all applicable health care laws, rules and regulations (except where such violation failure to operate or non-compliance would not not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect. “Health Care Laws” means ), including, without limitation, (i) the Food Federal Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the federal all applicable federal, state, local and state all applicable foreign healthcare related fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, the federal Anti-Kickback kickback Statute (42 U.S.C. § 1320a-7(b1320a-7b(b)), the U.S. 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 healthcare fraud and abuse, including but not limited to 18 U.S.C. Sections 1320a-7 286 and 1320a-7a of Title 42 of 287, the United States Code and healthcare fraud criminal provisions under the regulations promulgated pursuant to such statutes; (iii) the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), Section 1877 of the Social Security Act (42 U.S.C. 1395nn), and the civil monetary penalties law (42 U.S.C. § 1320a-7a); (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health, and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256bSection 17921 et seq.), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (viiiv) quality, safety the regulations promulgated pursuant to such laws; and accreditation requirements of all applicable state laws or regulatory bodies; (viiiv) any and all other applicable federalsimilar local, state, federal, or foreign health care laws or regulations, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contrarycollectively, the Company makes no representations or warranties regarding compliance by “Health Care Laws”). Neither the Company, nor to the Company’s physician customers with applicable lawsKnowledge, any of its officers, directors, employees or agents have 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 healthcare program. The Company has not received written notice or other correspondence of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action (“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, 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 does not have 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, neither the Company, nor to the Company’s Knowledge, any of its employees, officers or directors, has been excluded, suspended or debarred from participation in any U.S. state or 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.

Compliance with Health Care Laws. Neither Except as disclosed in the Company Registration Statement, the Pricing Disclosure Package and the Prospectus, and except as would not, individually or any subsidiaryin the aggregate, nor the Company’s or any subsidiary’s business operations is in violation of any Health Care Laws, except where such violation would not reasonably be expected to result in have a Material Adverse Effect: the Company and its subsidiaries are, and have since February 1, 2020 been, in compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the Food Drug Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectus, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), 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; (iii) the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191), as amended by the Health Information Technology for Economic and Clinical Health, and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (vii) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256bSection 201 et seq.), the VA Federal Supply Schedule and (38 U.S.C. § 8126iii) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other applicable federal, state, or local and foreign health care laws 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, 1035, 1347, and 1349 the health care fraud criminal provisions under HIPAA , the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions law (42 U.S.C. Section 1320a-7), and the Physician Payments Sunshine Act (42 U.S.C Section 1320-7h); and the regulations promulgated pursuant to such laws. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or regulationsother 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, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contraryCompany’s knowledge, has any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action been threatened. Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company makes no representations and its subsidiaries have filed, maintained or warranties regarding compliance submitted all 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 respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries, or any of their respective employees, officers, directors, or to the Company’s physician customers knowledge, any of their respective agents, is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with applicable lawsor imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor any of their respective employees, officers, directors, or to the Company’s knowledge, its 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 would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. Neither Without limiting the generality of clause (xvii) above and except as described in the Registration Statement, the U.S. Prospectus and the Canadian Prospectus, neither the Company or any subsidiary, nor the Company’s 's or any subsidiary’s 's business operations is in violation of any Health Care Laws, except where such violation the failure to be in compliance would not reasonably be expected to result in a Material Adverse Effect. “For purposes of this Agreement, "Health Care Laws” means " means: (i) the Food U.S. federal Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.)Act, and the regulations promulgated thereunder; (ii) the federal all U.S and Canadian federal, state and provincial fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, the U.S. federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), the U.S. Stark Law (42 U.S.C. Section 1395nn), the U.S. civil False Claims Clxxxx Act (31 U.S.C. § Section 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; (iii) the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191), as amended by the Health Information Technology for Economic and Clinical Health, and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (iv) the U.S. Controlled Substances Act; (v) Medicaid (Title Titles XVIII and XIX of the U.S. Social Security Act) Act and the regulations promulgated thereunder; (vi) the collection and reporting requirementsU.S. Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programspromulgated thereunder; (vii) quality, safety and accreditation standards and requirements of all applicable state and provincial laws or regulatory bodies; and (viii) any and all other applicable federal, state, or foreign health care laws or laws, regulations, including for manual provisions, policies and administrative guidance, each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contrary, the Company makes no representations or warranties regarding compliance by the Company’s physician customers with applicable laws.

Compliance with Health Care Laws. Neither The Company and its directors, officers, employees, contractors, and agents are, and for the Company or any subsidiaryprevious three (3) years have been, nor the Company’s or any subsidiary’s business operations is in violation of any compliance with all applicable Health Care Laws, as defined below, except where such violation noncompliance would not reasonably be expected to to, individually or in the aggregate, result in a Material Adverse Effectmaterial adverse effect on the Company. For purposes of this Agreement, “Health Care Laws” means means: (i) the Food Drug Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.), the Public Health Service Act (42 U.S.C. §§ 201 et seq.) and the regulations promulgated thereunder; (ii) the federal all applicable federal, state, and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslocal laws, including, but not limited towithout limitation, the federal U.S. Anti-Kickback Statute (42 U.S.C. § 1320a-7(b1320a-7b(b)), the civil U.S. False Statements Law (42 U.S.C. § 1320a-7b(a)), the Civil Monetary Penalties Law (42 U.S.C. §1320a-7a), the U.S. Civil False Claims Act (31 U.S.C. § 3729 et seq.), the administrative False Claims Law (42 all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. §§ 1320a-7b(a))286 and 287, Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191“HIPAA”) (42 U.S.C. §§1320d et seq.), as amended by the Health Information Technology for Economic Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the exclusions law (42 U.S.C. § 1320a-7), the statutes, regulations and Clinical Healthdirectives of applicable government funded or sponsored healthcare programs, and the regulations promulgated thereunderpursuant to such statutes, (iv) including but not limited to the coverage and payment provisions of Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) Medicaid (Title XIX of the Social Security Act); (iii) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, the Health Information Technology for Economic and Clinical Health Act (“HITECH Act”) (42 U.S.C. §§ 17921 et seq.), and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) thereunder and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), law or regulation the Public Health Service Act (42 U.S.C. § 256b), purpose of which is to protect the VA Federal Supply Schedule (38 U.S.C. § 8126) privacy of individuals or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programsprescribers; (viiiv) 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 of all under applicable state laws or regulatory bodiesRegulatory Agencies; and (viiivi) any and all other applicable federal, state, or foreign health care laws or regulations, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein and regulations applicable to the contraryownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product candidate manufactured or distributed by the Company. 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 authority or Regulatory Agency or third party alleging that any product operation or activity is in material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor, to the Company’s knowledge, its officers, directors, employees, contractors or agents, is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental authority or Regulatory Agency. Neither the Company nor, to the Company’s knowledge, any of its employees, contractors, agents, officers or directors 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, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, or exclusion. Except as would not reasonably be expected to, individually or in the aggregate, result in a material adverse effect on the Company, the Company makes no representations has filed, obtained, maintained or warranties regarding compliance submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by the Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were timely, complete, accurate and not misleading on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Except as would not reasonably be expected to, individually or in the aggregate, result in a material adverse effect on the Company’s physician customers , the Company possesses and is in compliance with applicable lawsall licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Health Care Laws except where such noncompliance would not be expected to, individually or in the aggregate, have a material adverse effect on the Company. The Company has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other written correspondence or notice from the FDA or any other Regulatory Agency or governmental entity alleging or asserting material noncompliance with any Health Care Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Health Care Laws. Except as would not reasonably be expected to, individually or in the aggregate, result in a material adverse effect on the Company, the Company has fulfilled and performed all of their respective material obligations with respect to all licenses, sublicenses, certificates, permits and other authorizations and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other impairment of the rights of the holder.

Compliance with Health Care Laws. Neither the The Company or any subsidiaryand Senseonics are, nor the Company’s or any subsidiary’s business operations is and have been, in violation of any compliance with all applicable Health Care Laws, and 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, federal or national health care program, except where such violation noncompliance, false claims liability or civil penalties would not reasonably be expected to to, singly or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means (i) all health care laws applicable to the Food Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the ProspectusCompany, including, but not limited to: the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), the civil Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the 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; (iii) health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), HIPAA, as amended by the Health Information Technology for Economic and Clinical HealthHealth Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) ), Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other applicable federalcomparable local, state, or federal, national, supranational and foreign health care laws or regulationsand the regulations promulgated pursuant to such laws, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding Neither the foregoing Company nor Senseonics have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or anything herein 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 contraryknowledge of the Company or Senseonics, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor Senseonics have received any written notice of adverse filing, warning letter, untitled letter or other correspondence or notice from the FDA, the European Commission, the EMA or any other Health Regulatory Agencies, or any other court or arbitrator, alleging or asserting material noncompliance with the Health Care Laws. Neither the Company makes nor Senseonics are a party to and have no representations ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or warranties regarding compliance similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor Senseonics nor, to the knowledge of the Company’s physician customers with applicable laws, 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 Health Care Laws. Neither the The Company or any subsidiary, nor the Company’s or any subsidiary’s business operations has operated and currently is in violation of any Health Care Lawscompliance with all applicable health care laws, except where such violation would not reasonably be expected to result in a Material Adverse Effect. “Health Care Laws” means rules and regulations, including, without limitation, (i) the Food Federal, Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the federal all applicable federal, state, local and state all applicable foreign healthcare related fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b1320a-7b(b)), the U.S. 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 healthcare fraud and abuse, including but not limited to 18 U.S.C. Sections 1320a-7 286 and 1320a-7a of Title 42 of 287, the United States Code and healthcare fraud criminal provisions under the regulations promulgated pursuant to such statutes; (iii) the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), and the civil monetary penalties law (42 U.S.C. § 1320a-7a); (iii) any applicable provisions of HIPAA, as amended by the Health Information Technology for Economic and Clinical Health, and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256bSection 17921 et seq.), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (viiiv) quality, safety the regulations promulgated pursuant to such laws; and accreditation requirements of all applicable state laws or regulatory bodies; (viiiv) any and all other applicable federalsimilar local, state, federal, or foreign health care laws or regulations, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contrarycollectively, the Company makes no representations “Health Care Laws”) , except where failure to be so in compliance would not reasonably be expected, individually or warranties regarding compliance by in the aggregate, to have a Material Adverse Effect. Neither the Company, nor, to the Company’s physician customers with applicable lawsknowledge, any of its officers, directors, employees or agents have 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 healthcare program. The Company has not received written notice or other correspondence of any claim, action, suit, audit, survey, 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, 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 does not have 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, neither the Company, nor any of its employees, officers, directors, employees or agents, has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or 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 Health Care Laws. Neither the Company or any subsidiary, nor the Company’s or any subsidiary’s business operations is in violation of any Health Care Laws, except where such violation Except as would not reasonably be expected expected, individually or in the aggregate, to result in a Material Adverse EffectChange, the Company and its subsidiaries are, and during the last five (5) years have been, in compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the Food Drug Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ Section 301 et seq.), the applicable provisions of the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) the federal all applicable federal, state, local and state foreign health care fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), 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 287, the criminal health care fraud law (18 U.S.C. Section 1347), the civil monetary penalties law (42 of U.S.C. Section 1320a-7a), the United States Code exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and the regulations promulgated pursuant to such statutesapplicable laws governing governmental health care programs; (iii) the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191)HIPAA, as amended by the Health Information Technology for Economic and Clinical Health, and the regulations promulgated thereunder, Health Act (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder42 U.S.C. Section 17921 et seq.); (v) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirementslicensure, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation requirements of all under applicable state federal, state, local or foreign laws or regulatory bodies; and (viiivi) any and all other applicable federallocal, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign health care laws its subsidiaries, and (vii) the regulations promulgated pursuant to such statutes and any state or regulationsnon-U.S. counterpart thereof. In the past five (5) years, including for each neither the Company nor any of (i) through (viii) as its subsidiaries has 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 or may be amended from time to time. Notwithstanding the foregoing or anything herein in material violation of any Health Care Laws nor, to the contraryCompany’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened or contemplated. Except as would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Change, the Company makes no representations and its subsidiaries have filed, maintained or warranties regarding compliance 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 nor any of its subsidiaries is a party to any corporate integrity agreement, monitoring agreement, consent decree, settlement order, or similar agreement with or imposed by any Regulatory Agency. Additionally, neither the Company’s physician customers with applicable laws, any of its subsidiaries, nor any of their respective employees, officers, directors, managing employees, owners or, to the knowledge of the Company, agents has been excluded, suspended or debarred from participation in any U.S. governmental 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.

Compliance with Health Care Laws. Neither the The Company or any subsidiaryis, nor the Company’s or any subsidiary’s business operations is and has been, in violation of any 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 violation noncompliance, false claims liability or civil penalties would not reasonably be expected to to, singly or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means (i) all health care laws applicable to the Food Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the ProspectusCompany, including, but not limited to: the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), the civil Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the 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; (iii) health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191“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, and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viiiSection 17921 et seq.) any and all other applicable federalcomparable local, state, or federal, national, supranational and foreign health care laws or regulationsand the regulations promulgated pursuant to such laws, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding ; for the foregoing avoidance of doubt Health Care Laws excludes any U.S. federal laws, statutes, codes, ordinances, decrees, rules or anything herein regulations which apply to the contraryproduction, 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. §841(a). The Company makes no representations has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or warranties regarding compliance by 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’s physician customers , 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 the FDA, the European Commission, the EMA or any other Health Regulatory Agencies, or any other court or arbitrator, alleging or asserting material noncompliance with applicable lawsthe 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 Health Care Laws. Neither Except as disclosed in the Company SEC Reports, and except as would not, individually or any subsidiaryin the aggregate, nor the Company’s or any subsidiary’s business operations is in violation of any Health Care Laws, except where such violation would not reasonably be expected to result in have a Material Adverse Effect: the Company and its subsidiaries are, and have since June 1, 2019 been, in compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the Food Drug Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.)and the regulations promulgated thereunder; and (ii) the federal all applicable federal, state, local and state foreign health care fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, the federal U.S. Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), the civil U.S. Civil False Claims Act (31 U.S.C. § Section 3729 et seq.), the administrative criminal False Claims Statements Law (42 U.S.C. § Section 1320a-7b(a)), 18 U.S.C. Sections 1320a-7 286, 287, 1035, 1347, and 1320a-7a of Title 1349, the health care fraud criminal provisions under HIPAA, the civil monetary penalties law (42 of U.S.C. Section 1320a-7a), the United States Code exclusions law (42 U.S.C. Section 1320a-7) and the Physician Payments Sunshine Act (42 X.X.X Xxxxxxx 0000-0x); and the regulations promulgated pursuant to such statutes; (iii) laws. Neither the Health Insurance Portability and Accountability Act Company nor any of 1996 (Pub. L. No. 104-191), as amended by the Health Information Technology for Economic and Clinical Health, and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing its subsidiaries has received written notice of any applicable rebateclaim, chargeback action, suit, proceeding, hearing, enforcement, investigation, arbitration or adjustmentother 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, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and Company’s Knowledge, has any state supplemental rebate programsuch claim, Medicare average sales price reporting (42 U.S.C. § 1395w-3a)action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action been threatened. Except as would not, individually or in the Public Health Service Act (42 U.S.C. § 256b)aggregate, the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other applicable federal, state, or foreign health care laws or regulations, including for each of (i) through (viii) as may reasonably be amended from time expected to time. Notwithstanding the foregoing or anything herein to the contraryhave a Material Adverse Effect, the Company makes no representations and its subsidiaries have filed, maintained or warranties regarding compliance submitted all 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 respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries, or any of their respective employees, officers, directors, or to the Company’s physician customers Knowledge, any of their respective agents, is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with applicable lawsor imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor any of their respective employees, officers, directors, or to the Company’s Knowledge, its agents, has 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.

Compliance with Health Care Laws. Neither the The Company or any subsidiary, nor the Company’s or any subsidiary’s business operations is and its subsidiaries are and have been in violation of any compliance with all Health Care LawsLaws (as hereinafter defined), except where such violation instances of non-compliance would not not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means (i) all health care laws applicable to the Food Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the ProspectusCompany, including, but not limited to: the Federal Food, Drug, and Cosmetic Act, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), the civil Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the 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; (iii) health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), HIPAA, as amended by the Health Information Technology for Economic and Clinical HealthHealth Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) ), Medicaid (Title XIX of the Social Security Act) ), and any and all other similar state, local or federal health care laws and the regulations promulgated thereunder; (vi) the collection and reporting requirementspursuant to such laws, and the processing of any applicable rebateincluding, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a)without limitation, the Public Health Service Act (42 U.S.C. § 256b)FDA’s current good manufacturing practice regulations at 21 CFR Part 820, the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other laws and regulations applicable federalto ownership, statetesting, development, manufacture, packaging, processing, use, distribution, storage, import, export or foreign health care laws or regulationsdisposal of the Company’s products, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding The Company and its subsidiaries 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 health care program or federal health care program, except where such noncompliance, false claims liability or civil penalties would not reasonably be expected to, singly or in the foregoing or anything herein to the contraryaggregate, result in a Material Adverse Effect. Neither the Company makes no representations nor any of its subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or warranties regarding compliance by other action from any court or arbitrator or governmental or regulatory authority or third party alleging a material violation of any Health Care Laws, and, to the Company’s physician customers knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor any of its subsidiaries are a party to and have 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 applicable lawsor imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries, 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, 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 could reasonably be expected to result in debarment, suspension, or exclusion. Except as described in the Registration Statement, the General Disclosure Package or the Prospectus or as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect, neither the Company nor any of its subsidiaries have 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.

Compliance with Health Care Laws. Neither the The Company or any subsidiaryand its subsidiaries are, nor the Company’s or any subsidiary’s business operations is and at all times have been, in violation of any compliance with all applicable Health Care LawsLaws except to the extent that any non-compliance would not, except where such violation would not individually or in the aggregate, reasonably be expected to result in have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means means: (i) the Food Drug Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.)and the regulations promulgated thereunder; (ii) the federal all applicable federal, state, and state local health care fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, , the federal U.S. Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), the civil U.S. Civil False Claims Act (31 U.S.C. § Section 3729 et seq.), the administrative criminal False Claims 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; (iii) the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191“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), and laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health, and the regulations promulgated thereunder, Health Act (42 U.S.C. Section 17921 et seq.); (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Physician Payment Sunshine Act (42 U.S.C. § 256b1320a-7h), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (viiv) licensure, quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other under applicable federal, state, or foreign health care local laws or regulationsregulatory bodies; and (vi) all other local, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein state, federal, national, supranational and foreign laws, relating to the contrary, regulation of the Company makes no representations or warranties regarding compliance by its subsidiaries, and (vii) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any of its subsidiaries has 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 physician customers knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect. 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 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 nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with applicable lawsor imposed by any governmental or regulatory authority. Additionally, neither the Company, any of its subsidiaries nor, to the knowledge of the Company, any of their respective employees, officers, directors, or 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 would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. Neither Except as described in the Registration Statement and the Prospectus, the Company or any subsidiary, nor the Company’s or any subsidiary’s business operations is and its subsidiaries are in violation of any compliance with all Health Care Laws, Laws except where such violation failure to be in compliance would not reasonably be expected to result in have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means means: (i) all applicable federal, state, local and foreign clinical laboratory licensing, permitting and registration laws, including, without limitation, the Food Drug and Cosmetic Act Clinical Laboratory Improvement Amendments of 1988 (21 42 U.S.C. §§ 301 Section 263a et seq.); (ii) the federal all applicable federal, state, local and state foreign health care fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, the federal U.S. Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), the civil U.S. Civil False Claims Act (31 U.S.C. § Section 3729 et seq.), the administrative criminal False Claims Statements Law (42 U.S.C. § Section 1320a-7b(a)), 18 U.S.C. Sections 1320a-7 286, and 1320a-7a of Title 287, the health care fraud criminal provisions under HIPAA, the Xxxxx Law (42 of U.S.C. Section 1395nn), the United States Code Civil Monetary Penalties Laws (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7); (iii) HIPAA, as amended by the HITECH Act; (iv) licensure, quality, safety and accreditation requirements under applicable federal, state, local and foreign laws and regulatory bodies; and (v) the regulations promulgated pursuant to such statutes; (iii) the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191), as amended by the Health Information Technology for Economic and Clinical Health, and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) statutes and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), or non-U.S. counterpart thereof. Neither the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) Company nor any of its subsidiaries has received written notice of any Action from any court or under any state pharmaceutical assistance program arbitrator or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation requirements of all applicable state laws governmental or regulatory bodies; (viii) authority or third party alleging that any and all other applicable federalproduct, stateoperation or activity is in material violation of any Health Care Laws nor, or foreign health care laws or regulations, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contraryCompany’s knowledge, is any such Action threatened, except where such Action would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company makes no representations and its subsidiaries have filed, maintained or warranties regarding compliance submitted all 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 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 any of their respective employees, officers, directors, or to the Company’s physician customers with applicable lawsknowledge, 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.

Compliance with Health Care Laws. Neither the The Company or any subsidiaryand Senseonics are, nor the Company’s or any subsidiary’s business operations is and have been, in violation of any compliance with all applicable Health Care Laws, and 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, federal or national health care program, except where such violation noncompliance, false claims liability or civil penalties would not reasonably be expected to to, singly or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means (i) all health care laws applicable to the Food Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the ProspectusCompany, including, but not limited to: the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.); the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), ; the civil Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a); the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h); the 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; (iii) health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191“HIPAA”) (42 U.S.C. Section 1320d et seq.); the exclusion laws (42 U.S.C. § 1320a-7); HIPAA, as amended by the Health Information Technology for Economic and Clinical Health, and the regulations promulgated thereunder, Health Act (iv) 42 U.S.C. Section 17921 et seq.); Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) ), Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder); (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other applicable federalcomparable local, state, or federal, national, supranational and foreign health care laws or regulationsand the regulations promulgated pursuant to such laws, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding Neither the foregoing Company nor Senseonics has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or anything herein 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 contraryknowledge of the Company or Senseonics, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor Senseonics has received any written notice of adverse filing, warning letter, untitled letter or other correspondence or notice from the FDA, the European Commission, the EMA or any other Health Regulatory Agencies, or any other court or arbitrator, alleging or asserting material noncompliance with the Health Care Laws. Neither the Company makes no representations nor Senseonics is a party to or warranties regarding compliance 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. Additionally, neither the Company nor Senseonics nor, to the knowledge of the Company’s physician customers with applicable laws, any of their respective 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 Health Care Laws. Neither the Company or any subsidiaryFor purposes of this Agreement, nor the Company’s or any subsidiary’s business operations is in violation of any Health Care Laws, except where such violation would not reasonably be expected to result in a Material Adverse Effect. “Health Care Laws” means includes: (i) the Food Drug Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.)and the regulations promulgated thereunder; (ii) the federal all federal, state, local and state all foreign health care related fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, the federal U.S. Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), the civil U.S. Civil False Claims Act (31 U.S.C. § Section 3729 et seq.), the administrative False Claims Law Physician Payments Sunshine Act (42 U.S.C. § 1320a-7b(a)1320a-7h), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code Code, and the regulations promulgated pursuant to such statutes; (iii) any criminal laws relating to health care fraud and abuse, including but not limited to the Criminal False Claims Act (42 U.S.C. § 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical HealthHealth Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) Medicare (Title XVIII of the Social Security U.S. Controlled Substances Act) and the regulations promulgated thereunder; (v) Medicaid (Title XIX of the Social Security Act) and the any laws or regulations promulgated thereunder; (vi) the collection and reporting requirementsthat govern participation in or coverage or reimbursement from any U.S. or state health care program, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating including but not limited to the Medicaid Drug Rebate Program Medicare statute (42 U.S.C. §§ 1396r-8) and any state supplemental rebate program1395-1395hhh), Medicare average sales price reporting Medicaid statute (42 U.S.C. §§ 1395w-3a1396-1396v), federal TRICARE statute (10 U.S.C. §1071 et seq.), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule Veterans Administration drug pricing program (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement), and any successor government programsregulations promulgated thereunder; and (vii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viiivi) any and all other applicable federal, state, or foreign health care laws or regulationsand regulations in any jurisdiction. Without limiting the generality of subsection 1(a)(44) above, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contrary, neither the Company makes no representations nor any of its subsidiaries has in the last five (5) years been, or warranties regarding is currently, in violation of any applicable Health Care Laws, except where the failure to be in compliance by would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect. Additionally, neither the Company nor any of its subsidiaries, employees, officers, directors, nor, to the Company’s physician customers knowledge, agents or contractors, has been excluded, suspended or debarred from participation in any federal health care program or, to the knowledge of Company, is subject to an inquiry, investigation, proceeding, or other similar matter that could subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment. Except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect, neither the Company nor any of its subsidiaries have received any written notice of adverse finding, warning letter, untitled letter or other written correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting non-compliance with applicable laws(a) any Health Care Laws or (b) or any Authorizations required by any such Health Care Laws (“Regulatory Authorizations”). Except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect: the Company and its subsidiaries possess all Regulatory Authorizations required to conduct the business as currently conducted and such Regulatory Authorizations are valid and in full force and effect and the Company and its subsidiaries are not in violation of any term of any such Regulatory Authorizations. The Company and its subsidiaries have not received written notice of any Proceeding from any governmental authority alleging a violation of any Health Care Laws or Regulatory Authorizations or limiting, suspending, modifying, or revoking any Regulatory Authorizations, and have no knowledge that any governmental authority is considering any such Proceeding, except for such Proceedings, which if resolved adversely to the Company or its Subsidiaries, would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect. The Company and its subsidiaries have filed, obtained, maintained or submitted all Submissions as required by any Health Care Laws or Regulatory Authorizations (“Reports”) and all such Reports were complete and correct on the date filed (or were corrected or supplemented by a subsequent Submission), except where the failure to so file, declare, obtain, maintain, submit, correct or supplement, or where the failure to be complete and correct on the date filed or to be corrected or supplemented by a subsequent Submission, would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect. The Company and its subsidiaries are not a party to and have 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 authority including any government agencies.

Compliance with Health Care Laws. Neither the The Company or any subsidiary, nor the Company’s or any subsidiary’s business operations is and has been in violation of any compliance with all Health Care LawsLaws (as hereinafter defined), except where such violation instances of non-compliance would not not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means (i) all health care laws applicable to the Food Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the ProspectusCompany, including, but not limited to: the Federal Food, Drug, and Cosmetic Act, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), the civil Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the 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; (iii) health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), HIPAA, as amended by the Health Information Technology for Economic and Clinical HealthHealth Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) ), Medicaid (Title XIX of the Social Security Act) ), and any and all other similar state, local or federal health care laws and the regulations promulgated thereunder; (vi) the collection and reporting requirementspursuant to such laws, and the processing of any applicable rebateincluding, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a)without limitation, the Public Health Service Act (42 U.S.C. § 256b)FDA’s current good manufacturing practice regulations at 21 CFR Part 820, the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other laws and regulations applicable federalto ownership, statetesting, development, manufacture, packaging, processing, use, distribution, storage, import, export or foreign health care laws or regulationsdisposal of the Company’s products, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding The 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, except where such noncompliance, false claims liability or civil penalties would not reasonably be expected to, singly or in the foregoing aggregate, result in a Material Adverse Effect. The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or anything herein other action from any court or arbitrator or governmental or regulatory authority or third party alleging a material violation of any Health Care Laws, and, to the contraryCompany’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, 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, 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 could reasonably be expected to result in debarment, suspension, or exclusion. Except as described in the Registration Statement, the General Disclosure Package or the Prospectus or as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company makes no representations has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or warranties regarding compliance 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 the Company’s physician customers with applicable lawsany such Health Care Laws.

Compliance with Health Care Laws. Neither the The Company or any subsidiary, nor the Company’s or any subsidiary’s business operations is in violation and each of any Health Care Laws, except where such violation would not reasonably be expected to result in a Material Adverse Effect. “Health Care Laws” means its subsidiaries: (i) has operated and currently operates its business in compliance in all material respects with applicable provisions of all applicable health care laws, including Title XVIII of the Food Drug Social Security Act, 42 U.S.C. §§ 1395-1395hhh (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396v (the Medicaid statute); the Federal Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x); the civil False Claims Act, 31 U.S.C. §§ 3729 et seq.; the criminal False Claims Act 42 U.S.C. 1320a-7b(a); the criminal laws relating to health care fraud and abuse, including 18 U.S.C. Sections 286 and 287 and the health care fraud criminal provisions under HIPAA; the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a and 1320a-7b; the Physician Payments Xxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; the exclusion law, 42 U.S.C. § 1320a-7; HIPAA, as amended by the HITECH Act; the Federal Food, Drug, and Cosmetic Act (Act, 21 U.S.C. §§ 301 et seq.); (ii) the federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the ProspectusPublic Health Service Act, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. §§ 1320a-7(b)), the civil False Claims Act (31 U.S.C. § 3729 201 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 FDA’s current good manufacturing practice regulations at 21 CFR Part 211; the regulations promulgated pursuant to such statuteslaws; (iii) the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191), as amended by the Health Information Technology for Economic and Clinical Health, and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other similar applicable federal, state, local or foreign health care laws and regulations of any governmental authority including the Regulatory Agencies applicable to the ownership, testing, development, manufacture, packaging, processing, use, sale, distribution, storage, import, export or regulationsdisposal of any of the Company’s product candidates, but in each case, excluding Privacy Laws (collectively, the “Health Care Laws”); (ii) has not received any United States Food and Drug Administration 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 non-compliance with (A) any Health Care Laws or (B) any licenses, approvals, clearances, exemptions, permits, registrations, authorizations, and supplements or amendments thereto required by any such Health Care Laws (“Regulatory Authorizations”); (iii) possesses all Regulatory Authorizations required to conduct its business as currently conducted and such Regulatory Authorizations are valid and in full force and effect and the Company is not in violation, in any material respect, of any term of any such Regulatory Authorizations; (iv) has fulfilled and performed all of its material obligations with respect to the Regulatory Authorizations required to conduct its business as currently conducted and, to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment of the rights of the holder of any such Regulatory Authorization; (v) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (“Proceeding”) from any governmental authority including for each any Regulatory Agency or any other third party alleging a material violation of any Health Care Laws or Regulatory Authorizations or limiting, suspending, or revoking any material Regulatory Authorizations, and has no knowledge that any governmental authority including any Regulatory Agencies or any other third party is considering any Proceeding; (ivi) through has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, submissions and supplements or amendments as required by any Health Care Laws or Regulatory Authorizations (“Reports”) required to conduct its business as currently conducted and that all such Reports were materially complete and correct on the date filed (or were materially corrected or supplemented by a subsequent submission); (vii) along with its employees, officers and directors, and to the Company’s knowledge, independent contractors and agents, is not a party to 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 authority including any Regulatory Agencies; and (viii) as may be amended from time along with its employees, officers and directors, and to time. Notwithstanding the foregoing or anything herein to the contrary, the Company makes no representations or warranties regarding compliance by the Company’s physician customers knowledge, independent contractors and agents, has not been excluded, suspended or debarred from, or otherwise rendered ineligible for participation in any government health care program or human clinical research. Any certificate signed by an officer of the Company and delivered to Cowen or to counsel for Cowen pursuant to or in connection with applicable lawsthis Agreement shall be deemed to be a representation and warranty by the Company to Cowen as to the matters set forth therein. The Company acknowledges that Cowen and, for purposes of the opinions to be delivered pursuant to Section 7 hereof, counsel to the Company and counsel to Cowen, will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.

Compliance with Health Care Laws. Neither To the extent applicable to the Company or any subsidiaryand its business, nor the Company’s or any subsidiary’s business operations is Company and its subsidiaries are, and at all times have been, in violation of any compliance in all material respects with all Health Care Laws. For purposes of this Agreement, except where such violation would not reasonably be expected to result in a Material Adverse Effect. “Health Care Laws” means the following, in each case as applicable to the Company or its subsidiaries: (i) the Food Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); applicable FDA Laws, (ii) the federal all applicable federal, state, local and state all applicable foreign health care related fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, the federal U.S. Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), the U.S. civil monetary penalties law (42 U.S.C. § 1320a-7a), the U.S. Civil False Claims Act (31 U.S.C. § Section 3729 et seq.), the administrative False Claims Law U.S. criminal false statements law (42 U.S.C. § 1320a-7b(a)), all applicable federal, state, local and all foreign 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; (iii) health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191“HIPAA”) (42 U.S.C. Section 1320d et seq.), as amended by the U.S. exclusion law (42 U.S.C. § 1320a-7), the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes, (iii) applicable requirements under HIPAA, the Health Information Technology for Economic and Clinical HealthHealth Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunderthereunder and any state or non-U.S. counterpart thereof, (iv) Medicare the U.S. Patient Protection and Affordable Care Act of 2010 (Title XVIII Public Law 111-148), as amended by the U.S. Health Care and Education Reconciliation Act of the Social Security Act) and 2010 (Public Law 111-152), the regulations promulgated thereunder; (v) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service U.S. Physician Payments Sunshine Act (42 U.S.C. § 256b1320a-7h), (vi) the VA Federal Supply Schedule U.S. Controlled Substances Act (38 21 U.S.C. § 8126Section 801 et seq.) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other applicable federallocal, state, or federal, national, supranational and foreign health care laws or regulations, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein applicable to the contraryCompany and its subsidiaries. The Company and its subsidiaries have not received written notice of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Authority alleging potential or actual non-compliance by, or liability of, the Company makes no representations or warranties regarding compliance any subsidiary under any Health Care Laws. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, submissions and supplements or amendments thereof as required by any applicable Health Care Laws, and all such reports, documents, forms, notices, applications, records, submissions and supplements or amendments were complete and accurate on the Company’s physician customers with applicable lawsdate filed in all material respects (or were corrected or supplemented by a subsequent submission).

Compliance with Health Care Laws. Neither In the Company or any subsidiarypast three years, nor the Company, XXXX XX and the Company’s or any subsidiary’s business operations is subsidiaries have operated at all times and are currently in violation of any compliance with all Health Care Laws, Laws except where such violation failure to be in compliance would not reasonably be expected to result in have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means means: (i) the Food Drug all applicable federal, state, local and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the federal and state foreign health care fraud and abuse laws referred laws, such as, to generally or specifically in the Preliminary Prospectus and the Prospectus, including, but not limited toextent applicable, the federal U.S. Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), the civil U.S. Civil False Claims Act (31 U.S.C. § Section 3729 et seq.), the administrative criminal False Claims Statements Law (42 U.S.C. § Section 1320a-7b(a)), 18 U.S.C. Sections 1320a-7 286, and 1320a-7a of Title 287, the health care fraud criminal provisions under HIPAA, the Civil Monetary Penalties Law (42 of the United States Code U.S.C. Section 1320a-7a), and the regulations promulgated pursuant to such statutesexclusion law (42 U.S.C. Section 1320a-7); (iiiii) to the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191)extent applicable, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health, and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security HITECH Act) and the regulations promulgated thereunder; (viii) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirementslicensure, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other under applicable federal, state, or local and foreign health care laws or regulationsand regulatory bodies; and (iv) all other applicable local, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein state, federal, national, supranational and foreign laws, relating to the contraryregulation of the Company, XXXX XX and the Company makes no representations Company’s subsidiaries and the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or warranties regarding compliance disposal of any product under development, manufactured or distributed by the Company, XXXX XX or the Company’s physician customers subsidiaries. In the past three years, neither the Company, XXXX XX nor the Company’s subsidiaries has received written notice of any 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 or ATAI AG’s knowledge, is any such Action threatened, except where such action would not, individually or in the aggregate, have a Material Adverse Effect. In the past three years, except as would not, individually or in the aggregate, have a Material Adverse Effect, the Company, XXXX XX and the Company’s subsidiaries have filed, maintained or submitted all reports, documents, forms, notices, applications, records, claims submissions and supplements or amendments as required by any applicable 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, XXXX XX nor the Company’s subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with applicable lawsor imposed by any governmental or regulatory authority. Additionally, in the past three years, none of the Company, XXXX XX, the Company’s subsidiaries or any of their respective employees, officers, directors, or to the Company’s or ATAI AG’s knowledge, 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 or XXXX XX, 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 Health Care Laws. Neither Except as would not, singly or in the Company or any subsidiaryaggregate, nor the Company’s or any subsidiary’s business operations is in violation of any Health Care Laws, except where such violation would not reasonably be expected to result in a Material Adverse Effect. “Effect or except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, neither the Company, nor the Company’s business operations, is in violation of any Health Care Laws” . For purposes of this Agreement, "Health Care Laws" means (iA) the Food Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the all federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), the Xxxxx Law (42 U.S.C. §1395nn and §1395(q)), the Anti-Inducement Law (42 U.S.C. § 1320a-7(b1320a-7a(a)(5)), the civil False Claims Act (31 U.S.C. § 3729 X.X.X. §0000 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), Sections 1320a-7 and 1320a-7a of Title the exclusion laws (42 of U.S.C. § 1320a-7), the United States Code civil monetary penalty laws (42 U.S.C. § 1320a-7a) and the regulations promulgated pursuant to such statutes; , (iiiB) the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191), as amended by ) and the Health Information Technology for Economic and Clinical HealthHealth Act of 2009, and the regulations promulgated thereunderthereunder and comparable state privacy and security laws, (ivC) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; , (vD) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; , (viE) the collection and reporting requirementsFederal Food, Drug, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program Cosmetic Act (42 21 U.S.C. § 1396r-8301 et seq.) and any state supplemental rebate programthe regulations promulgated pursuant thereto, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (viiF) quality, safety and accreditation standards and requirements of all applicable state laws or regulatory bodies; bodies and (viiiG) any and all other applicable federal, state, or foreign health care laws or laws, regulations, including for manual provisions, policies and administrative guidance, each of (iA) through (viiiG) as may be amended from time to time. Notwithstanding Except as would not, singly or in the foregoing aggregate, reasonably be expected to result in a Material Adverse Effect or anything herein to except as disclosed in the contraryRegistration Statement, the General Disclosure Package and the Prospectus, the Company makes has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity alleging that any product, operation or activity is in violation of any applicable Health Care Law or permit and has no representations knowledge that any such Governmental Entity is considering any such claim, litigation, arbitration, action, suit, investigation or warranties regarding compliance by proceeding; and the Company’s physician customers with applicable lawsCompany has not received notice, either verbally or in writing, that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any permits and has no knowledge that any such Governmental Entity is considering such action, except for any of the foregoing that would not reasonably be expected to result in a Material Adverse Effect.

Compliance with Health Care Laws. Neither Except as would not, singly or in the Company or any subsidiaryaggregate, nor the Company’s or any subsidiary’s business operations is in violation of any Health Care Laws, except where such violation would not reasonably be expected to result in a Material Adverse Effect, the Company and its subsidiaries are, and at all times have been, in compliance with all applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the Food Drug Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ Section 301 et seq.); (ii) the federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectus, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), 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; (iii) the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191), as amended by the Health Information Technology for Economic and Clinical Health, and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256bSection 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable U.S. federal, state, local and non-U.S. health care fraud and abuse laws, including, without limitation, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the VA Federal Supply Schedule Civil False Claims Act (38 31 U.S.C. § 8126) or Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreementHIPAA, 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 any successor applicable laws governing government funded or sponsored healthcare programs; (viiiii) HIPAA, as amended by the HITECH Act; (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 of all under applicable state U.S. federal, state, local or non-U.S. laws or regulatory bodies; (viiivi) any and all other applicable federallocal, state, or foreign U.S. federal, national, supranational and non-U.S. health care laws or regulations, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein relating to the contrary, regulation of the Company makes no representations or warranties regarding compliance by its subsidiaries, and (vii) the regulations promulgated pursuant 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, notice of adverse finding, warning letter, untitled letter or 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 nor, to the Company’s physician customers knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened or pending. 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 applicable lawsor imposed by any governmental or regulatory authority. Additionally, none of the Company, any of its subsidiaries nor any of their respective employees, officers, directors or, to the Company’s knowledge, their respective agents has been excluded, suspended, debarred or disqualified 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, disqualification, suspension, or exclusion.

Compliance with Health Care Laws. Neither the The Company or any subsidiary, nor the Company’s or any subsidiary’s business operations is and its subsidiaries have been and are in violation of any compliance in all material respects with all applicable Health Care Laws, except where such violation failure to be so in compliance would not reasonably be expected expected, individually or in the aggregate, to result in have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means means: (i) the Food Drug Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.)) and the regulations promulgated thereunder; (ii) the federal all applicable federal, state, local and state all applicable foreign health care related fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, the federal U.S. Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), the civil U.S. Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the U.S. 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 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of Title 1996 (“HIPAA”) (42 of U.S.C. Section 1320d et seq.), the United States Code exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated pursuant to such statutes; (iii) the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191), as amended by the Health Information Technology for Economic and Clinical Health, and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder); (viv) Medicaid (Title XIX of the Social Security Act); (v) the Controlled Substances Act (21 U.S.C. §§ 801 et seq.) and the regulations promulgated thereunder; and (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other applicable federal, state, or foreign health care laws or and regulations, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contrary, Neither the Company makes no representations nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or warranties regarding compliance by other action from any court or arbitrator or governmental or regulatory authority alleging that any product operation or activity is in material violation of any Health Care Laws, and, to the Company’s physician customers knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened against the Company or any of its subsidiaries. Neither the Company nor any of its subsidiaries is a party to 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 applicable lawsor imposed by any Regulatory Agency or other governmental or regulatory authority. Additionally, neither the Company, any of its subsidiaries nor any of their respective employees, officers or directors 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.

Compliance with Health Care Laws. Neither the Company or any subsidiary, nor their respective officers, directors, employees, agents and contractors (exercising their respective duties on behalf of the Company or any subsidiary), nor the Company’s or any subsidiary’s business operations is operations, is, or at any time has been, in violation of any Health Care Laws, except where such violation would not reasonably be expected to result in a Material Adverse Effect. “Health Care Laws” means shall mean (i) the Food federal Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 321 et seq.); , and the regulations promulgated thereunder, (ii) the all federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b§1320a-7b(b)), the civil Xxxxx Law (42 U.S.C. § 1395nn), the Civil False Claims Act (31 U.S.C. § 3729 et seq.), the administrative Administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; , (iii) the administrative simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-19142 U.S.C. §§ 1320d-1320d-8), as amended by the Health Information Technology for Economic regulations promulgated thereunder and Clinical Healthcomparable state laws, (iv) the Controlled Substances Act (21 U.S.C. § 801 et seq.), (v) Titles XVIII (42 U.S.C. § 1395 et seq.) and XIX (42 U.S.C. § 1396 et seq.) of the Social Security Act and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation standards and requirements of all applicable foreign or state laws or regulatory bodies; , and (viiivii) any and all other applicable federal, state, or foreign health care laws or laws, regulations, including for manual provisions, policies and administrative guidance, each of (i) through (viiivii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contrary, the Company makes no representations or warranties regarding compliance by the Company’s physician customers with applicable laws.

Compliance with Health Care Laws. Neither (a) Except as disclosed in Section 3.23(a) of the Company or any subsidiaryDisclosure Letter, nor Company and its Subsidiaries are, and since January 1, 2008 have been, in material compliance with the Company’s or any subsidiary’s business operations is in violation Medicare statute (Title XVIII of any Health Care Lawsthe Social Security Act), except where such violation would not reasonably be expected to result in a Material Adverse Effect. “Health Care Laws” means the Medicaid statute (i) Title XIX of the Food Social Security Act), the federal Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectus, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b1320a-7b(b)), any applicable state fraud and abuse prohibitions, including those that apply to all payors (governmental, commercial insurance and self-payors), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), 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 the civil monetary penalty laws (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) U.S.C. § 1320a-7a), the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-19142 U.S.C. §§ 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical HealthHealth Act of 2009 (collectively, “HIPAA”), the exclusion laws (42 U.S.C. § 1320a-7), and any comparable state or local laws, and the regulations promulgated thereunderpursuant to such laws, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other applicable federal, state, or foreign health care laws or regulations, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing , and any other state or anything herein to the contraryfederal law, regulation, guidance document, manual provision, program memorandum, opinion letter, or other public issuance which regulates kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the Company makes no representations hiring of employees or warranties regarding compliance by the Company’s physician customers with applicable lawsacquisition 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 services (each, a “Health Care Law”).

Compliance with Health Care Laws. Neither the The Company or any subsidiaryand its subsidiaries are, nor the Company’s or any subsidiary’s business operations is and since June 1, 2018 have been, in violation of any compliance with all Health Care Laws, except as otherwise described in the Disclosure Documents or where such violation the failure to so comply would not not, individually or in the aggregate, reasonably be expected to result in have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means means: (i) the Food Drug Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.)and the regulations promulgated thereunder; (ii) the federal all applicable federal, state, local and state foreign health care fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, the federal U.S. Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), the civil U.S. Civil False Claims Act (31 U.S.C. § Section 3729 et seq.), the administrative criminal False Claims Statements Law (42 U.S.C. § Section 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, 287 and 1320a-7a of Title 42 of the United States Code 1347 and the regulations promulgated pursuant to such statutes; (iii) the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191)health care fraud criminal provisions under HIPAA, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health, and the regulations promulgated thereunder, (iv) Medicare (Title XVIII Health Act of the Social Security Act) and the regulations promulgated thereunder; (v) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program 2009 (42 U.S.C. § 1396r-8) and any state supplemental rebate program17921 et seq.), Medicare average sales price reporting the civil monetary penalties law (42 U.S.C. § 1395w-3aSection 1320a-7a), the Public Health Service exclusions law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. § 256bX.X.X Xxxxxxx 0000-0x), and the VA Federal Supply Schedule (38 U.S.C. § 8126) laws governing U.S. government funded or under sponsored healthcare programs. Since June 1, 2018, except as otherwise described in the Disclosure Documents or would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, neither the Company nor any state pharmaceutical assistance program of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or U.S. Department of Veterans Affairs agreement, and other action from any successor government programs; (vii) quality, safety and accreditation requirements of all applicable state laws court or arbitrator or governmental or regulatory bodies; (viii) authority that any and all other applicable federalproduct, stateoperation, or foreign health care laws or regulationsactivity is in violation of any Health Care Laws nor, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contrary, the Company makes no representations or warranties regarding compliance by the Company’s physician customers knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. Except as otherwise described in the Disclosure Documents, 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 applicable lawsor imposed by any governmental or regulatory authority or body. Additionally, since June 1, 2018, except as otherwise described in the Disclosure Documents, neither the Company, any of its subsidiaries nor to the Company’s knowledge, any of their respective employees, officers, directors, independent contractors, affiliates or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. Neither the The Company or any subsidiary, nor the Company’s or any subsidiary’s business operations has operated and currently is in violation of any Health Care Lawscompliance with all applicable health care laws, except where such violation would not reasonably be expected to result in a Material Adverse Effect. “Health Care Laws” means rules and regulations, including, without limitation, (i) the Food Federal, Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the federal all applicable federal, state, local and state all applicable foreign healthcare related fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b1320a-7b(b)), the U.S. 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 healthcare fraud and abuse, including but not limited to 18 U.S.C. Sections 1320a-7 286 and 1320a-7a of Title 42 of 287, the United States Code and healthcare fraud criminal provisions under the regulations promulgated pursuant to such statutes; (iii) the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), and the civil monetary penalties law (42 U.S.C. § 1320a-7a); (iii) any applicable provisions of HIPAA, as amended by the Health Information Technology for Economic and Clinical Health, and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256bSection 17921 et seq.), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (viiiv) quality, safety the regulations promulgated pursuant to such laws; and accreditation requirements of all applicable state laws or regulatory bodies; (viiiv) any and all other applicable federalsimilar local, state, federal, or foreign health care laws or regulations, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contrarycollectively, the Company makes no representations “Health Care Laws”), except where failure to be so in compliance would not reasonably be expected, individually or warranties regarding compliance by in the aggregate, to have a Material Adverse Effect. Neither the Company, nor, to the Company’s physician customers with applicable lawsknowledge, any of its officers, directors, employees or agents have 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 healthcare program. The Company has not received written notice or other correspondence of any claim, action, suit, audit, survey, 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, 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 does not have 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, neither the Company, nor any of its employees, officers, directors, employees or agents, has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or 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 Health Care Laws. Neither the Company or any subsidiary, nor the Company’s or any subsidiary’s business operations is in violation of any Health Care Laws, except where such violation Except as would not reasonably be expected to result result, individually or in the aggregate, in a Material Adverse Effect, the Company and its subsidiaries are and have been in compliance with all applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) all health care laws applicable to the Food Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the ProspectusCompany, including, but not limited to: the Federal Food, Drug, and Cosmetic Act, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b1320a-7b(b)), the civil Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payment Sunshine Act (42 U.S.C. § 1320a- 7h), the 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)), the Clinical Laboratory Improvement Act of 1988 (42 U.S.C. § 263a), 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; (iii) health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191“HIPAA”) (42 U.S.C. § 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), HIPAA, as amended by the Health Information Technology for Economic and Clinical HealthHealth Act (42 U.S.C. § 17921 et seq.), and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) ), Medicaid (Title XIX of the Social Security Act) ), and any and all other similar state, local or federal health care laws and the regulations promulgated thereunder; (vi) the collection and reporting requirementspursuant to such laws, and the processing of any applicable rebateincluding, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a)without limitation, the Public Health Service Act U.S. Food and Drug Administration (42 U.S.C. § 256bthe “FDA”)’s current good manufacturing practice regulations at 21 CFR Part 820, the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (vii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other laws and regulations applicable federalto ownership, statetesting, development, manufacture, packaging, processing, use, distribution, storage, import, export or foreign health care laws or regulationsdisposal of the Company’s products, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding The Company and its subsidiaries 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 health care program or federal health care program, except where such noncompliance, false claims liability or civil penalties would not reasonably be expected to, individually or in the foregoing or anything herein to the contraryaggregate, have a Material Adverse Effect. Neither the Company makes no representations nor any of its subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or warranties regarding compliance by other action from any court or arbitrator or governmental or regulatory authority or third party alleging a material violation of any Health Care Laws, and, to the Company’s physician customers knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened, that, individually or in the aggregate, if determined adversely to the Company or any of its subsidiaries, would reasonably be expected to have a Material Adverse Effect. Except for a Corporate Integrity Agreement executed with applicable lawsthe Office of Inspector General dated June 29, 2020, neither the Company nor any of its subsidiaries are a party to and have 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 subsidiaries, 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, 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 could reasonably be expected to result in debarment, suspension, or exclusion. Except as described in the Time of Sale Information or the Offering Memorandum or as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, neither the Company nor any of its subsidiaries have 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.

Compliance with Health Care Laws. Neither Except as described in each of the Registration Statement or the Prospectus and except as would be reasonably expected to have a Material Adverse Effect on the Company or any subsidiaryand its subsidiaries, nor taken as a whole, the Company’s or any subsidiary’s business operations is Company and its subsidiaries are, and at all times have been, in violation of any compliance with all applicable Health Care Laws. For purposes of this Agreement, except where such violation would not reasonably be expected to result in a Material Adverse Effect. “Health Care Laws” means means: (i) the Food Drug Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.), the Public Health Service Act (42 U.S.C. §§ 201 et seq.); (ii) the federal all applicable federal, state, local and state all applicable foreign health care related fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectuslaws, including, but not limited towithout limitation, the federal U.S. Anti-Kickback Statute (42 U.S.C. § 1320a-7(b1320a-7b(b)), the civil U.S. False Statements Law (42 U.S.C. § 1320a-7b(a)), the Civil Monetary Penalties Law (42 U.S.C. §1320a-7a), the U.S. Civil False Claims Act (31 U.S.C. § 3729 et seq.), the administrative False Claims Law (42 all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. §§ 1320a-7b(a))286 and 287, Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191“HIPAA”) (42 U.S.C. §§ 1320d et seq.), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion law (42 U.S.C. §1320a-7); (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health, and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. §§ 256b17921 et seq.), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (viiiv) quality, safety regulations promulgated pursuant to such statutes; and accreditation requirements of all applicable state laws or regulatory bodies; (viiiv) any and all other applicable federal, state, or foreign health care laws or regulations, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein and regulation applicable to the contraryownership, the Company makes no representations testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or warranties regarding compliance disposal of any product manufactured or distributed by the Company. Neither the Company nor its subsidiaries has 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 it is in violation of any Health Care Laws, and, to the Company’s physician customers knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor its subsidiaries, nor their respective officers, directors, employees, contractors or agents, is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with applicable lawsor imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its employees, officers, directors, contractors or agents, nor its subsidiaries or any of the subsidiary’s employees, officers, directors, contractors or agents, has been excluded, suspended or debarred from participation in any U.S. federal health care program (as defined in 42 U.S.C. § 1320a-7b(f)) 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 such debarment, suspension, or exclusion. The Company and its subsidiaries have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by the Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were timely, complete, accurate and not misleading on the date filed in all material respects (or were corrected or supplemented by a subsequent submission).

Compliance with Health Care Laws. Neither The Company and its subsidiaries are, and during the last three years have been in compliance and have taken any required and necessary actions to comply, and all of the Company’s and its subsidiaries’ products that are subject to the jurisdiction of the FDA or other governmental or regulatory authority are being manufactured, imported, exported, processed, developed, investigated, produced, labeled, stored, tested, marketed, promoted, advertised, distributed and sold by or on behalf of the Company or any subsidiaryits subsidiaries in compliance, nor the Company’s or any subsidiary’s business operations is in violation of any with all Health Care Laws, except where such violation noncompliance would not singly or in the aggregate reasonably be expected to result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means (i) all health care laws applicable to the Food Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) the federal and state fraud and abuse laws referred to generally Company or specifically in the Preliminary Prospectus and the Prospectusany of its subsidiaries, including, but not limited to: the Federal Food, Drug, and Cosmetic Act, the federal U.S. Anti-Kickback Statute (42 U.S.C. § 1320a-7(bSection 1320a-7b(b)), the civil Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the U.S. Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. § Section 3729 et seq.), the administrative criminal False Claims Law 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 1320a-7 286 and 1320a-7a of Title 42 of the United States Code 287, and the regulations promulgated pursuant to such statutes; (iii) health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), HIPAA, as amended by the Health Information Technology for Economic and Clinical HealthHealth Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) ), Medicaid (Title XIX of the Social Security Act), and any and all other similar state, local, federal or foreign (including Israeli) health care laws and the regulations promulgated thereunder; (vi) the collection and reporting requirementspursuant to such laws, and the processing of any applicable rebateincluding, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a)without limitation, the Public Health Service Act (42 U.S.C. § 256b)FDA’s current good manufacturing practice regulations at 21 CFR Part 820, the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreementgood clinical practice regulations at 21 CFR Parts 50, 54, 56 and any successor government programs; (vii) quality812, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any good laboratory practice regulations at 21 CFR Part 58 and all other laws and regulations applicable federalto non-clinical research, stateclinical research, establishment registration, device listing, pre-market notification, ownership, testing, development, manufacture, packaging, labeling, advertising, record-keeping, processing, use, distribution, adverse event reporting, reporting of corrections and removals, storage, import, export or foreign health care laws disposal of the Company’s or regulationsany of its subsidiaries’ products, including for each of (i) through (viii) as may be amended from time to time. Notwithstanding Neither the foregoing Company nor any of its subsidiaries has received any Form 483, notice of adverse finding, warning letter, untitled letter, requests or anything herein requirements to make changes to the contraryCompany’s or its subsidiaries’ products, manufacturing processes or procedures related to any product of the Company makes or its subsidiaries or other correspondence or notice from the FDA, or 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 alleging a material violation of any Health Care Laws, and, to the Company’s knowledge, no representations such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or warranties regarding compliance other action is threatened. Neither the Company nor its subsidiaries are subject to any obligation arising under an administrative or regulatory action, government or regulatory inspection, warning letter, notice of violation letter or other notice, response or commitment made to or with the FDA or any comparable governmental or regulatory authority; the Company and its subsidiaries have made all notifications, submissions, responses and reports required by FDA or other governmental or regulatory authority, including any such obligation arising under any administrative or regulatory action, inspection, warning letter, notice of violation letter or other notice, response or commitment made to or with the FDA or other governmental or regulatory authority, and all such notifications, submissions, responses and reports were true, complete and correct in all material respects as of the date of submission to the FDA or other governmental or regulatory authority. To the knowledge of the Company, no basis for liability exists with respect to any such notification, submission or report. During the last three years, no manufacturing site owned by the Company, its subsidiaries or, to the knowledge of the Company, any of their respective contract manufacturers, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or other governmental or regulatory authority. Neither the Company, any of its subsidiaries or any of its or their respective officers, directors, managing employees (as such terms are defined in 42 CFR § 1001.2), nor to the knowledge of the Company, any agent (as such term is defined in 42 CFR § 1001.2) of the Company or its subsidiaries is a party to or has ongoing 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, none the Company or any of its subsidiaries, or, to the knowledge of the Company, any of its or its subsidiaries’ employees, officers or directors (i) has been charged with or convicted of any criminal offense relating to the delivery of an item or service under any federal health care program, (ii) has been excluded, suspended or debarred from participation in any U.S. federal health care program or human research study or clinical trial or, to the knowledge of the Company, is subject to an inquiry, investigation, proceeding, or other similar action by any governmental authority that could reasonably be expected to result in debarment, suspension, or exclusion, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) is currently listed on the list of parties excluded from federal procurement programs and non-procurement programs as maintained in the Government Services Administration’s System for Award Management or other federal agencies, (v) to the knowledge of the Company, is the target or subject of any current or potential investigation relating to any federal health care program-related offense or (vi) has engaged in any activity that is in material violation of, or is cause for civil penalties or mandatory or permissive exclusion under, federal or state Laws. To the knowledge of the Company, any third Person that is a manufacturer or contractor for the Company or its subsidiaries is in compliance with all Health Care Laws and any other applicable Law insofar as they pertain to the manufacture of product components or products for the Company or its subsidiaries, except where noncompliance would not singly or in the aggregate reasonably be expected to result in a Material Adverse Effect. The Company and its subsidiaries have not either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any material recall, market withdrawal, or replacement, field notifications, field corrections, “dear doctor” letter, investigator notice, safety alert or other notice or action relating to an alleged lack of safety or efficacy or material regulatory compliance of any product or product candidate; and the Company and its subsidiaries are not aware of any facts which are reasonably likely to cause (i) the material recall, market withdrawal or replacement of any product sold or intended to be sold by the Company or its subsidiaries, (ii) a change in the marketing classification or a material change in the labeling of any such products or (iii) termination or suspension of the marketing or such products. Except as has not been, and would not reasonably be expected to be, individually or in the aggregate material to the Company and its subsidiaries, taken as a whole, (i) all agreements or other arrangements between the Company or any of its subsidiaries on the one hand and any physician customers on the other hand for services are in writing, describe bona fide services required by the Company or its subsidiaries, as the case may be, provide for compensation that is no more than fair market value for such services determined as of the effective date of the agreement, and are in material compliance with the Federal Anti-Kickback Statute (42 USC § 1320a-7b(b)) (“AKS”), (ii) all payments made and things of value provided by the Company or any of its subsidiaries to any healthcare professional for services rendered by such health care professional have been made at fair market value determined as of the effective date of any such agreement and are in material compliance with AKS and (iii) all such agreements, arrangements, payments and things of value are in compliance in all material respects with all applicable lawsLaws, including all Health Care Laws. The Company and its subsidiaries has timely, accurately and completely reported all payments and transfers of value made to physicians and teaching hospitals, as required by the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h) and the Company is in full compliance with all analogous state laws requiring the reporting of financial interactions with health care providers.