Common use of Compliance with Healthcare Laws Clause in Contracts

Compliance with Healthcare Laws. The Company and its subsidiaries and, to the Company's knowledge, their respective officers, directors, employees, and independent contractors: (i) during the past four (4) years, have complied with and are in compliance with applicable provisions of the health care laws, including Title XVIII of the 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 Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b); the civil False Claims Act, 31 U.S.C. §§ 3729 et seq.; the criminal False Claims Act 42 U.S.C. 1320a-7b(a); 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 the Health Insurance Portability and Accountability Act of 1996, 42 U.S.C. §§ 1320d et seq., (“HIPAA”); the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a and 1320a-7b; the Physician Payments Sunshine Act, 42 U.S.C. § 1320a-7h; the exclusion law, 42 U.S.C. § 1320a-7; HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH 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 pursuant to such laws; and any similar federal, state and local laws and regulations (collectively the “Health Care Laws”), except where such non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect; (ii) during the past four (4) years, the Company and its subsidiaries have not received any unresolved United States Food and Drug Administration Form 483, written notice of adverse finding, warning letter, untitled letter or other written correspondence or written notice from any court or arbitrator or Governmental Entity, including any notified body alleging or asserting non-compliance with (A) any Health Care Laws or (B) or any Governmental Licenses required by applicable Health Care Laws; (iii) during the past four (4) years have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (“Proceeding”) from any Governmental Entity or other third party alleging a material violation of any Health Care Laws, and has no knowledge that any Governmental Entity or other third party is considering any Proceeding; (iv) during the past four (4) years, have 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 (“Reports”) and that all such Reports were materially complete and correct on the date filed (or were materially corrected or supplemented by a subsequent submission); (v) are not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entity; and (vi) along with its employees, officers or directors, or, to the Company’s knowledge, independent contractors and agents, have not been excluded, suspended or debarred from, or otherwise ineligible for participation in any government health care program or human clinical research during the past four (4) years.

Compliance with Healthcare Laws. The Company is, and its subsidiaries andduring the last three (3) years, has been, in compliance with all Health Care Laws, except where failure to comply would not reasonably be expected, individually or in the aggregate, to the Company's knowledgeresult in a Material Adverse Effect. For purposes of this Agreement, their respective officers, directors, employees, and independent contractors“Health Care Laws” means: (i) during the past four Federal Food, Drug, and Cosmetic Act (421 U.S.C. Section 301 et seq.); (ii) yearsall applicable federal, have complied with state, local and are in compliance with applicable provisions of the foreign health care fraud and abuse laws, including Title XVIII of including, without limitation, the 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 federal Anti-Kickback Statute, Statute (42 U.S.C. § Section 1320a-7b(b); ), the civil federal Civil False Claims Act, Act (31 U.S.C. §§ Section 3729 et seq.; ), the criminal False Claims Act false statements law (42 U.S.C. Section 1320a-7b(a); the criminal laws relating to health care fraud and abuse), including 18 U.S.C. Sections 286 and 287 and 287, the health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996, (42 U.S.C. §§ Section 1320d et seq., ) (“HIPAA”); , the Civil Monetary Penalties Law, civil monetary penalties law (42 U.S.C. §§ 1320a-7a and 1320a-7b; Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the federal Physician Payments Sunshine Act, Act (42 U.S.C. § 1320a-7hSection 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; the exclusion law, 42 U.S.C. § 1320a-7; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH Act”), 42 U.S.C. §§ Section 17921 et seq.); the Federal Food(iv) all other similar local, Drugstate, federal, national, supranational and Cosmetic Act, 21 U.S.C. §§ 301 et seq.foreign laws; and (v) the regulations promulgated pursuant to such laws; and any similar federallaws set forth in subparts (i) through (iv). Except as would not reasonably be expected, state and local laws and regulations (collectively the “Health Care Laws”), except where such non-compliance would not, singly individually or in the aggregate, to result in a Material Adverse Effect; (ii) , during the past four last three (43) years, the Company and its subsidiaries have not received any unresolved United States Food and Drug Administration Form 483, written notice of adverse finding, warning letter, untitled letter or other written correspondence or written notice from any court or arbitrator or Governmental Entity, including any notified body alleging or asserting non-compliance with (A) any Health Care Laws or (B) or any Governmental Licenses required by applicable Health Care Laws; (iii) during the past four (4) years have has not received written notice of any claim, subpoena, civil investigative demand, action, suit, compliant (including a qui tam complaint), proceeding, hearing, enforcement, investigation, inquiry, arbitration or other action (“Proceeding”) from any Governmental Entity court or other arbitrator or governmental authority or third party alleging a material that any product, operation, or activity is in violation of any Health Care LawsLaws nor, and has no knowledge that to the Company’s knowledge, is any Governmental Entity such claim, subpoena, civil investigative demand, action, suit, complaint (including a qui tam complaint), proceeding, hearing, enforcement, investigation, inquiry, arbitration or other third party is considering any Proceeding; (iv) action threatened. Except as would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the past four last three (43) years, have the Company has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments (“Submissions”) as required by any Health Care Laws or Governmental Licenses (“Reports”) Laws, and that all such Reports Submissions were materially complete and correct accurate on the date filed (or were materially corrected or supplemented by a subsequent submission); . The Company is not, and has not during the last three (v3) are not years been, a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entity; and governmental authority. During the last three (vi3) along with years, neither the Company nor any of its respective employees, officers or officers, directors, or, to the Company’s knowledge, independent contractors and agents, have not agents has been excluded, suspended or debarred from, or otherwise ineligible for from participation in any government U.S. federal health care program or human clinical research during or, to the past four (4) yearsknowledge of the Company, is or could reasonably expected to be subject to an inquiry, investigation, proceeding or other similar action by the FDA, or other applicable regulatory authority or other governmental entity that could reasonably be expected to result in debarment, suspension or exclusion.

Compliance with Healthcare Laws. The Company and its subsidiaries and, to the Company's knowledge, their respective officers, directors, employees, and independent contractorssubsidiaries: (i) during the past four (4) years, have complied with and are in compliance with applicable provisions of the health care laws, including Title XVIII of the 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 Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b); the civil False Claims Act, 31 U.S.C. §§ 3729 et seq.; the criminal False Claims Act 42 U.S.C. 1320a-7b(a); 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 the Health Insurance Portability and Accountability Act of 1996, 42 U.S.C. §§ 1320d et seq., (“HIPAA”); the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a and 1320a-7b; the Physician Payments Sunshine Act, 42 U.S.C. § 1320a-7h; the exclusion law, 42 U.S.C. § 1320a-7; HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH 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 pursuant to such laws; and any similar federal, state and local laws and regulations (collectively the “Health Care Laws”), except where such non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect; (ii) during the past four (4) years, the Company and its subsidiaries have not received any unresolved United States Food and Drug Administration Form 483, written notice of adverse finding, warning letter, untitled letter or other written correspondence or written notice from any court or arbitrator or Governmental Entity, including any notified body alleging or asserting non-compliance with (A) any Health Care Laws or (B) or any Governmental Licenses required by applicable Health Care Laws; (iii) during the past four (4) years have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (“Proceeding”) from any Governmental Entity or other third party alleging a material violation of any Health Care Laws, and has no knowledge that any Governmental Entity or other third party is considering any Proceeding; (iv) during the past four (4) years, have 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 (“Reports”) and that all such Reports were materially complete complete, correct and correct not misleading on the date filed (or were materially appropriately corrected or supplemented by a subsequent submission); (v) are not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entity; and (vi) along with its their respective employees, officers or directors, or, to the Company’s knowledge, independent contractors and agents, have not been excluded, suspended or debarred fromdebarred, and have not been convicted of any crime or otherwise ineligible for participation engaged in any conduct that would result in an exclusion, suspension or debarment from any federal or state government health care program program, human research study, clinical trial, or human clinical research during registry, and have no knowledge that the past four (4) yearsCompany, its subsidiaries or their respective its directors, officers, employees or agents have been subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Healthcare Laws. The Company and its subsidiaries and, to the Company's knowledge, their respective officers, directors, employees, and independent contractors: (i) during the past four (4) years, have complied with and are in compliance with applicable provisions of the health care laws, including Title XVIII of the 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 AntiXxxx-Kickback StatuteXxxxxxxx Xxxxxxx, 42 U.S.C. 00 X.X.X. § 1320a-7b(b0000x-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 the Health Insurance Portability and Accountability Act of 1996, 42 U.S.C. §§ 1320d et seq., (“HIPAA”); the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a and 1320a-7b; the Physician Payments Sunshine ActXxxxxxxx Xxx, 42 U.S.C. 00 X.X.X. § 1320a-7h0000x-0x; the exclusion law, 42 U.S.C. § 1320a-7; HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH 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 pursuant to such laws; and any similar federal, state and local laws and regulations (collectively the “Health Care Laws”), except where such non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect; (ii) during the past four (4) years, the Company and its subsidiaries have not received any unresolved United States Food and Drug Administration Form 483, written notice of adverse finding, warning letter, untitled letter or other written correspondence or written notice from any court or arbitrator or Governmental Entity, including any notified body alleging or asserting non-compliance with (A) any Health Care Laws or (B) or any Governmental Licenses required by applicable Health Care Laws; (iii) during the past four (4) years have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (“Proceeding”) from any Governmental Entity or other third party alleging a material violation of any Health Care Laws, and has no knowledge that any Governmental Entity or other third party is considering any Proceeding; (iv) during the past four (4) years, have 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 (“Reports”) and that all such Reports were materially complete and correct on the date filed (or were materially corrected or supplemented by a subsequent submission); (v) are not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entity; and (vi) along with its employees, officers or directors, or, to the Company’s knowledge, independent contractors and agents, have not been excluded, suspended or debarred from, or otherwise ineligible for participation in any government health care program or human clinical research during the past four (4) years.

Compliance with Healthcare Laws. The Company and its subsidiaries and, to Except as described in the Company's knowledge, their respective officers, directors, employeesRegistration Statement or the Prospectus Supplement, and independent contractorsexcept as would not, individually or in the aggregate, have or may reasonably be expected to have a Material Adverse Effect: (i) during the past four (4) yearsCompany’s and each of its Subsidiaries’ business practices have been structured in a manner designed to comply with state, have complied with federal and foreign laws applicable to the Company and its Subsidiaries respective businesses, and the Company and its Subsidiaries are in compliance with such laws including, without limitation, applicable provisions of of: (A) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) and the Public Health Service Act (42 U.S.C. § 201 et seq.), and the regulations promulgated thereunder; (B) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including Title XVIII of including, without limitation, the Social Security Act, U.S. Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the U.S. civil False Claims Act (31 X.X.X. §0000 et seq.), the federal criminal false claims law (42 U.S.C. § 1395-1395hhh 1320a-7b(a)), the federal civil monetary penalties law (42 U.S.C. § 1320a-7a), the Medicare statute); Title XIX of the Social Security Act, Xxxxx Law (42 U.S.C. §§ 1396-1396v 1395nn), the U.S. Physician Payments Sunshine Act (the Medicaid statute); the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b1320a-7h); the civil False Claims Act, 31 18 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 §286, 287, 1347, and abuse, including 18 U.S.C. Sections 286 and 287 1349 and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996, 1996 (“HIPAA”) (42 U.S.C. §§ 1320d et seq.), the exclusion law (“HIPAA”); the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a and 1320a-7b; 1320a-7), Medicare, Title XVIII of the Physician Payments Sunshine Social Security Act, 42 U.S.C. § 1320a-7hand Medicaid, Title XIX of the Social Security Act, and the regulations promulgated pursuant to such statutes; the exclusion law, 42 U.S.C. § 1320a-7; and (C) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH 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 pursuant to such laws; thereunder and any similar federalstate or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers (collectively, state and local laws and regulations (collectively the “Health Care Laws”), except where such non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect; (ii) during the past four (4) years, the Company and its subsidiaries Subsidiaries have not received any unresolved United States Food and Drug Administration Form 483engaged in activities which are cause for false claims liability, written notice of adverse findingcivil penalties, warning letteror mandatory or permissive exclusion from Medicare, untitled letter or other written correspondence or written notice from any court or arbitrator or Governmental EntityMedicaid, including any notified body alleging or asserting non-compliance with (A) any Health Care Laws or (B) or any Governmental Licenses required by applicable Health Care Lawsother state health care program or federal health care program; (iii) during neither the past four (4) years Company nor its Subsidiaries have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (“Proceeding”) from any Governmental Entity court or other arbitrator or governmental or regulatory authority or third party alleging a material that any product, operation or activity is in violation of any Health Care LawsLaws nor, and has no knowledge that any Governmental Entity to the Company’s Knowledge, is any, such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other third party is considering any Proceedingaction threatened; (iv) during neither the past four Company nor any Subsidiary has received written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke applicable Material Permits or has any knowledge that any such court or arbitrator or governmental or regulatory authority is considering such action; (4v) years, 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 any Health Care Laws or Governmental Licenses (“Reports”) Laws, and that all such Reports reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct accurate on the date filed in all material respects (or were materially corrected or supplemented by a subsequent submission); (vvi) neither the Company nor its Subsidiaries are not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, plans of correction, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority; and (vivii) along with neither the Company, its Subsidiaries nor any of their respective officers, directors, employees, officers or directors, or, to the Company’s knowledge, independent contractors and agents, agents have not been excluded, suspended or debarred from, or otherwise ineligible for from participation in any government U.S. federal health care program or human clinical research during or, to the past four (4) yearsCompany’s Knowledge, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Healthcare Laws. The Company is, and its subsidiaries andduring the last three (3) years, has been, in compliance with all Health Care Laws, except where failure to comply would not reasonably be expected, individually or in the aggregate, to the Company's knowledgeresult in a Material Adverse Effect. For purposes of this Agreement, their respective officers, directors, employees, and independent contractors“Health Care Laws” means: (i) during the past four Federal Food, Drug, and Cosmetic Act (421 U.S.C. Section 301 et seq.); (ii) yearsall applicable federal, have complied with state, local and are in compliance with applicable provisions of the foreign health care fraud and abuse laws, including Title XVIII of including, without limitation, the 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 federal Anti-Kickback Statute, Statute (42 U.S.C. § Section 1320a-7b(b); ), the civil federal Civil False Claims Act, Act (31 U.S.C. §§ Section 3729 et seq.; ), the criminal False Claims Act false statements law (42 U.S.C. Section 1320a-7b(a); the criminal laws relating to health care fraud and abuse), including 18 U.S.C. Sections 286 and 287 and 287, the health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996, (42 U.S.C. §§ Section 1320d et seq., ) (“HIPAA”); , the Civil Monetary Penalties Law, civil monetary penalties law (42 U.S.C. §§ 1320a-7a and 1320a-7b; Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the federal Physician Payments Sunshine Act, Act (42 U.S.C. § 1320a-7hSection 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; the exclusion law, 42 U.S.C. § 1320a-7; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH Act”), 42 U.S.C. §§ Section 17921 et seq.); the Federal Food(iv) all other similar local, Drugstate, federal, national, supranational and Cosmetic Act, 21 U.S.C. §§ 301 et seq.foreign laws; and (v) the regulations promulgated pursuant to such laws; and any similar federallaws set forth in subparts (i) through (iv). Except as would not reasonably be expected, state and local laws and regulations (collectively the “Health Care Laws”), except where such non-compliance would not, singly individually or in the aggregate, to result in a Material Adverse Effect; (ii) , during the past four last three (43) years, the Company and its subsidiaries have not received any unresolved United States Food and Drug Administration Form 483, written notice of adverse finding, warning letter, untitled letter or other written correspondence or written notice from any court or arbitrator or Governmental Entity, including any notified body alleging or asserting non-compliance with (A) any Health Care Laws or (B) or any Governmental Licenses required by applicable Health Care Laws; (iii) during the past four (4) years have has not received written notice of any claim, subpoena, civil investigative demand, action, suit, compliant (including a qui tam complaint), proceeding, hearing, enforcement, investigation, inquiry, arbitration or other action (“Proceeding”) from any Governmental Entity court or other arbitrator or governmental authority or third party alleging a material that any product, operation, or activity is in violation of any Health Care LawsLaws nor, and has no knowledge that to the Company’s knowledge, is any Governmental Entity such claim, subpoena, civil investigative demand, action, suit, complaint (including a qui tam complaint), proceeding, hearing, enforcement, investigation, inquiry, arbitration or other third party is considering any Proceeding; (iv) action threatened. Except as would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect, during the past four last three (43) years, have the Company has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments (“Submissions”) as required by any Health Care Laws or Governmental Licenses (“Reports”) Laws, and that all such Reports Submissions were materially complete and correct accurate on the date filed (or were materially corrected or supplemented by a subsequent submission); . The Company is not, and has not during the last three (v3) are not years been, a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entity; and governmental authority. During the last three (vi3) along with years, neither the Company nor any of its employees, officers or officers, directors, or, to the Company’s knowledge, independent contractors and agents, have not been excluded, suspended or debarred from, or otherwise ineligible for from participation in any government U.S. federal health care program or human clinical research during or, to the past four (4) yearsknowledge of the Company, is or could reasonably expected to be subject to an inquiry, investigation, proceeding or other similar action by the FDA, or other applicable regulatory authority or other governmental entity that could reasonably be expected to result in debarment, suspension or exclusion.

Compliance with Healthcare Laws. The Company and its subsidiaries and, to the Company's ’s knowledge, their respective its directors, officers, directors, employees, and independent contractors: agents (iwhile acting in such capacity) during are, and at all times have been, in material compliance with, all healthcare laws applicable to the past four (4) yearsCompany and its subsidiaries or any of its products or activities, have complied with and are in compliance with applicable provisions of including, but not limited to, the health care laws, including Title XVIII of the 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 federal Anti-Kickback Statute, Statute (42 U.S.C. § 1320a-7b(b); ), the civil False Claims Act, Act (31 U.S.C. §§ 3729 et seq.; ), the criminal False Claims Act Law (42 U.S.C. § 1320a-7b(a); ), the federal Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the civil monetary penalties laws (42 U.S.C. § 1320a-7a), all 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 287, the Health Insurance Portability and Accountability Act of 1996, 1996 (42 U.S.C. §§ 1320d et seq., (“HIPAA”); the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a and 1320a-7b; the Physician Payments Sunshine Act, 42 U.S.C. § 1320a-7h; the exclusion law, 42 U.S.C. § 1320a-7; HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH Act”), 42 U.S.C. §§ 17921 et seq.; ), the exclusion laws (42 U.S.C. § 1320a-7), the Federal Food, Drug, and Cosmetic Act, Act (21 U.S.C. §§ 301 et seq.; ), the Controlled Substances Act (21 U.S.C. §§ 801 et seq.), the Public Health Services Act, the Medicare statute (Title XVIII of the Social Security Act), the Medicaid statute (Title XIX of the Social Security Act), each as amended, the regulations promulgated pursuant to such laws; , and any similar federalother state or federal law, state and local laws and regulations which imposes requirements on the manufacturing, development, testing, labeling, marketing or distribution of pharmaceutical products, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care programs, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care or pharmaceutical services (collectively the collectively, “Health Care Healthcare Laws”), except where such non-compliance would notand have not engaged in activities which are, singly as applicable, prohibited or in the aggregatecause for false claim liability, result in a Material Adverse Effect; (ii) during the past four (4) yearscivil penalties, the or mandatory or permissive exclusion from Medicare, Medicaid or any other state or federal health care program. The Company and its subsidiaries have has not received any unresolved United States Food and Drug Administration Form 483notification, written notice of adverse finding, warning letter, untitled letter correspondence or any other written correspondence or written notice from any court or arbitrator or Governmental Entitycommunication, including any notified body alleging or asserting non-compliance with (A) any Health Care Laws or (B) or any Governmental Licenses required by applicable Health Care Laws; (iii) during the past four (4) years have not received written notice notification of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (“ProceedingAction”) from any Governmental Entity court, arbitrator, third-party, or other third party alleging a material violation governmental or regulatory authority, including, without limitation, the FDA, the Drug Enforcement Administration, the Centers for Medicare and Medicaid Services, or the U.S. Department of Health and Human Services Office of Inspector General, of potential or actual non-compliance by, or liability of, the Company or its subsidiaries under any Health Care Healthcare Laws, and has no knowledge that any Governmental Entity or other third party is considering any Proceeding; (iv) during the past four (4) years, have 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 (“Reports”) and that all such Reports were materially complete and correct on the date filed (or were materially corrected or supplemented by a subsequent submission); (v) are not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entity; and (vi) along with its employees, officers or directors, or, to the knowledge of the Company’s knowledge, independent contractors and agents, have not been excluded, suspended or debarred from, or otherwise ineligible for participation in any government health care program or human clinical research during the past four (4) yearsno such Action is threatened.

Compliance with Healthcare Laws. The Company and its subsidiaries Subsidiaries and, to the Company's ’s knowledge, their respective its directors, officers, directors, employees, and independent contractors: agents (iwhile acting in such capacity) during are, and at all times have been, in material compliance with, all healthcare laws applicable to the past four (4) yearsCompany and its Subsidiaries or any of its products or activities, have complied with and are in compliance with applicable provisions of including, but not limited to, the health care laws, including Title XVIII of the 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 federal Anti-Kickback Statute, Statute (42 U.S.C. § 1320a-7b(b); ), the civil False Claims Act, Act (31 U.S.C. §§ 3729 et seq.; ), the criminal False Claims Act Law (42 U.S.C. § 1320a-7b(a); ), the federal Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the civil monetary penalties laws (42 U.S.C. § 1320a-7a), all 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 287, the Health Insurance Portability and Accountability Act of 1996, 1996 (42 U.S.C. §§ 1320d et seq., (“HIPAA”); the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a and 1320a-7b; the Physician Payments Sunshine Act, 42 U.S.C. § 1320a-7h; the exclusion law, 42 U.S.C. § 1320a-7; HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH Act”), 42 U.S.C. §§ 17921 et seq.; ), the exclusion laws (42 U.S.C. § 1320a-7), the Federal Food, Drug, and Cosmetic Act, Act (21 U.S.C. §§ 301 et seq.; ), the Controlled Substances Act (21 U.S.C. §§ 801 et seq.), the Public Health Services Act, the Medicare statute (Title XVIII of the Social Security Act), the Medicaid statute (Title XIX of the Social Security Act), each as amended, the regulations promulgated pursuant to such laws; , and any similar federalother state or federal law, state and local laws and regulations which imposes requirements on the manufacturing, development, testing, labeling, marketing or distribution of pharmaceutical products, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care programs, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care or pharmaceutical services (collectively the collectively, “Health Care Healthcare Laws”), except where such non-compliance would notand have not engaged in activities which are, singly as applicable, prohibited or in the aggregatecause for false claim liability, result in a Material Adverse Effect; (ii) during the past four (4) yearscivil penalties, the or mandatory or permissive exclusion from Medicare, Medicaid or any other state or federal health care program. The Company and its subsidiaries have has not received any unresolved United States Food and Drug Administration Form 483notification, written notice of adverse finding, warning letter, untitled letter correspondence or any other written correspondence or written notice from any court or arbitrator or Governmental Entitycommunication, including any notified body alleging or asserting non-compliance with (A) any Health Care Laws or (B) or any Governmental Licenses required by applicable Health Care Laws; (iii) during the past four (4) years have not received written notice notification of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (“ProceedingAction”) from any Governmental Entity court, arbitrator, third- party, or other third party alleging a material violation governmental or regulatory authority, including, without limitation, the United States Food and Drug Administration (“FDA”), the Drug Enforcement Administration (“DEA”), the Centers for Medicare and Medicaid Services, or the U.S. Department of Health and Human Services Office of Inspector General, of potential or actual non- compliance by, or liability of, the Company or its Subsidiaries under any Health Care Laws, and has no knowledge that any Governmental Entity or other third party is considering any Proceeding; (iv) during the past four (4) years, have 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 (“Reports”) and that all such Reports were materially complete and correct on the date filed (or were materially corrected or supplemented by a subsequent submission); (v) are not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entity; and (vi) along with its employees, officers or directors, or, to the knowledge of the Company’s knowledge, independent contractors and agents, have not been excluded, suspended or debarred from, or otherwise ineligible for participation in any government health care program or human clinical research during the past four (4) yearsno such Action is threatened.

Compliance with Healthcare Laws. The Company Except as described in the Registration Statement and its subsidiaries andthe Prospectus, and except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company's knowledge, their respective officers, directors, employees, and independent contractors: (i) during the past four (4) years, have complied with has operated and are currently operates its business in compliance with applicable provisions of the health care laws, including Title XVIII of the 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 Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b); the civil False Claims Act, 31 U.S.C. §§ 3729 et seq.; the criminal False Claims Act 42 U.S.C. 1320a-7b(a); 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 the Health Insurance Portability and Accountability Act of 1996, 42 U.S.C. §§ 1320d et seq., (“HIPAA”); the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a and 1320a-7b1320a-7a; the Physician Payments Sunshine Act, 42 U.S.C. § 1320a-7h; the exclusion lawExclusion Law, 42 U.S.C. § 1320a-7; HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH 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 pursuant 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 where such non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect; (ii) during the past four (4) years, the Company and its subsidiaries have has not received any unresolved United States Food and Drug Administration FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other written correspondence or written notice from any court or arbitrator or Governmental Entity, including any notified body governmental or regulatory authority alleging or asserting non-compliance with (A) any Health Care Laws or (B) or any Governmental Licenses licenses, approvals, clearances, exemptions, permits, registrations, authorizations, and supplements or amendments thereto required by applicable any such Health Care LawsLaws (“Regulatory Authorizations”); (iii) during 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 past four Company is not in violation, in any material respect, of any term of any such Regulatory Authorizations; (4iv) years have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (“Proceeding”) from any Governmental Entity governmental authority including any Regulatory Agency or any other third party alleging a material violation of any Health Care LawsLaws or Regulatory Authorizations or limiting, suspending, modifying, or revoking any material Regulatory Authorizations, and has no knowledge that any Governmental Entity governmental authority including any Regulatory Agencies or any other third party is considering any Proceeding; (ivv) during the past four (4) years, have 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 Regulatory Authorizations (“Reports”) and that all such Reports were materially complete and correct on the date filed (or were materially corrected or supplemented by a subsequent submission); (vvii) are is not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entitygovernmental authority including any Regulatory Agencies; and (viviii) along with its employees, officers or and directors, or, to the Company’s knowledge, independent contractors and agents, have has not been excluded, suspended or debarred from, or otherwise ineligible for participation in any government health care program or human clinical research during the past four (4) yearsresearch.

Compliance with Healthcare Laws. The Company and its subsidiaries and, to Except as described in the Company's knowledge, their respective officers, directors, employeesRegistration Statement or the Prospectus Supplement, and independent contractorsexcept as would not, individually or in the aggregate, have or may reasonably be expected to have a Material Adverse Effect: (i) during the past four (4) yearsCompany’s and each of its Subsidiaries’ business practices have been structured in a manner designed to comply with state, have complied with federal and foreign laws applicable to the Company and its Subsidiaries respective businesses, and the Company and its Subsidiaries are in compliance with such laws including, without limitation, applicable provisions of of: (A) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) and the Public Health Service Act (42 U.S.C. § 201 et seq.), and the regulations promulgated thereunder; (B) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including Title XVIII of including, without limitation, the Social Security Act, U.S. Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the U.S. civil False Claims Act (31 X.X.X. §0000 et seq.), the federal criminal false claims law (42 U.S.C. § 1395-1395hhh 1320a-7b(a)), the federal civil monetary penalties law (42 U.S.C. § 1320a-7a), the Medicare statute); Title XIX of the Social Security Act, Xxxxx Law (42 U.S.C. §§ 1396-1396v 1395nn), the U.S. Physician Payments Sunshine Act (the Medicaid statute); the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b1320a-7h); the civil False Claims Act, 31 18 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 §286, 287, 1347, and abuse, including 18 U.S.C. Sections 286 and 287 1349 and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996, 1996 (“HIPAA”) (42 U.S.C. §§ 1320d et seq.), the exclusion law (“HIPAA”); the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a and 1320a-7b; 1320a-7), Medicare, Title XVIII of the Physician Payments Sunshine Social Security Act, 42 U.S.C. § 1320a-7hand Medicaid, Title XIX of the Social Security Act, and the regulations promulgated pursuant to such statutes; the exclusion law, 42 U.S.C. § 1320a-7; and (C) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH 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 pursuant to such laws; thereunder and any similar federalstate or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers (collectively, state and local laws and regulations (collectively the “Health Care Laws”), except where such non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect; (ii) during the past four (4) years, the Company and its subsidiaries Subsidiaries have not received any unresolved United States Food and Drug Administration Form 483engaged in activities which are cause for false claims liability, written notice of adverse findingcivil penalties, warning letteror mandatory or permissive exclusion from Medicare, untitled letter or other written correspondence or written notice from any court or arbitrator or Governmental EntityMedicaid, including any notified body alleging or asserting non-compliance with (A) any Health Care Laws or (B) or any Governmental Licenses required by applicable Health Care Lawsother state health care program or federal health care program; (iii) during neither the past four (4) years Company nor its Subsidiaries have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (“Proceeding”) from any Governmental Entity court or other arbitrator or governmental or regulatory authority or third party alleging a material that any product, operation or activity is in violation of any Health Care LawsLaws nor, and has no knowledge that any Governmental Entity to the Company’s Knowledge, is any, such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other third party is considering any Proceedingaction threatened; (iv) during neither the past four Company nor any Subsidiary has received written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke applicable Material Permits, nor, to the Company’s Knowledge, that any such court or arbitrator or governmental or regulatory authority is considering such action; (4v) years, 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 any Health Care Laws or Governmental Licenses (“Reports”) Laws, and that all such Reports reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct accurate on the date filed in all material respects (or were materially corrected or supplemented by a subsequent submission); (vvi) neither the Company nor its Subsidiaries are not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, plans of correction, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority; and (vivii) along with neither the Company, its Subsidiaries nor any of their respective officers, directors, employees, officers or directors, or, to the Company’s knowledge, independent contractors and agents, agents have not been excluded, suspended or debarred from, or otherwise ineligible for from participation in any government U.S. federal health care program or human clinical research during or, to the past four (4) yearsCompany’s Knowledge, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Healthcare Laws. The Company and its subsidiaries and, to the Company's ’s knowledge, their respective its directors, officers, directors, employees, and independent contractors: agents (iwhile acting in such capacity) during are, and at all times have been, in material compliance with, all healthcare laws applicable to the past four (4) yearsCompany and its subsidiaries or any of its products or activities, have complied with and are in compliance with applicable provisions of including, but not limited to, the health care laws, including Title XVIII of the 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 federal Anti-Kickback Statute, Statute (42 U.S.C. § 1320a-7b(b); ), the civil False Claims Act, Act (31 U.S.C. §§ 3729 et seq.; ), the criminal False Claims Act Law (42 U.S.C. § 1320a-7b(a); ), the federal Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the civil monetary penalties laws (42 U.S.C. § 1320a-7a), all 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 287, the Health Insurance Portability and Accountability Act of 1996, 1996 (42 U.S.C. §§ 1320d et seq., (“HIPAA”); the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a and 1320a-7b; the Physician Payments Sunshine Act, 42 U.S.C. § 1320a-7h; the exclusion law, 42 U.S.C. § 1320a-7; HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH Act”), 42 U.S.C. §§ 17921 et seq.; ), the exclusion laws (42 U.S.C. § 1320a-7), the Federal Food, Drug, and Cosmetic Act, Act (21 U.S.C. §§ 301 et seq.; ), the Controlled Substances Act (21 U.S.C. §§ 801 et seq.), the Public Health Services Act, the Medicare statute (Title XVIII of the Social Security Act), the Medicaid statute (Title XIX of the Social Security Act), each as amended, the regulations promulgated pursuant to such laws; , and any similar federalother state or federal law, state and local laws and regulations which imposes requirements on the manufacturing, development, testing, labeling, marketing or distribution of pharmaceutical products, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care programs, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care or pharmaceutical services (collectively the collectively, “Health Care Healthcare Laws”), except where such non-compliance would notand have not engaged in activities which are, singly as applicable, prohibited or in the aggregatecause for false claim liability, result in a Material Adverse Effect; (ii) during the past four (4) yearscivil penalties, the or mandatory or permissive exclusion from Medicare, Medicaid or any other state or federal health care program. The Company and its subsidiaries have has not received any unresolved United States Food and Drug Administration Form 483notification, written notice of adverse finding, warning letter, untitled letter correspondence or any other written correspondence or written notice from any court or arbitrator or Governmental Entitycommunication, including any notified body alleging or asserting non-compliance with (A) any Health Care Laws or (B) or any Governmental Licenses required by applicable Health Care Laws; (iii) during the past four (4) years have not received written notice notification of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (“ProceedingAction”) from any Governmental Entity court, arbitrator, third-party, or other third party alleging a material violation governmental or regulatory authority, including, without limitation, the United States Food and Drug Administration (“FDA”), the Drug Enforcement Administration (“DEA”), the Centers for Medicare and Medicaid Services, or the U.S. Department of Health and Human Services Office of Inspector General, of potential or actual non-compliance by, or liability of, the Company or its subsidiaries under any Health Care Laws, and has no knowledge that any Governmental Entity or other third party is considering any Proceeding; (iv) during the past four (4) years, have 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 (“Reports”) and that all such Reports were materially complete and correct on the date filed (or were materially corrected or supplemented by a subsequent submission); (v) are not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entity; and (vi) along with its employees, officers or directors, or, to the knowledge of the Company’s knowledge, independent contractors and agents, have not been excluded, suspended or debarred from, or otherwise ineligible for participation in any government health care program or human clinical research during the past four (4) yearsno such Action is threatened.