Common use of Compliance with Healthcare Laws Clause in Contracts

Compliance with Healthcare Laws. The Company: (i) has operated and currently operates its business in compliance in all material respects with applicable provisions of the health care laws, including Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395lll (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396w-5 (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. §§ 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; 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 Health Act, 42 U.S.C. §§ 17921 et seq.; the 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.; the regulations promulgated pursuant to such laws; and any similar federal, state, local and foreign laws and regulations of any governmental authority including the United States Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, 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”); (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 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 any Regulatory Agency or any other third party alleging a material violation of any Health Care Laws or Regulatory Authorizations or limiting, suspending, modifying, 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; (vi) 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 (“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); (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) along with its employees, officers and directors, and, to the Company’s knowledge, independent contractors and agents, has not been excluded, suspended or debarred from, or otherwise ineligible for participation in any government health care program or human clinical research.

Compliance with Healthcare Laws. The Company: (i) has operated Company and currently operates its business subsidiaries have been in compliance in all material respects with all applicable provisions of the health care healthcare laws, including Title XVIII of rules and regulations, to the Social Security Actextent they apply to the Company and its current activities, 42 including, without limitation, (i) the FDCA (21 U.S.C. §§ 1395-1395lll (the Medicare statute301 et seq.); Title XIX of (ii) all applicable foreign, federal, state and local healthcare related fraud and abuse laws, including, without limitation, the Social Security Act, federal Anti-kickback Statute (42 U.S.C. §§ 1396-1396w-5 (the Medicaid statute1320a-7b(b); 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 criminal False Claims Act Law (42 U.S.C. § 1320a-7b(a); ), the civil monetary penalties law (42 U.S.C. § 1320a-7a), the exclusion laws (42 U.S.C. § 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), all criminal laws relating to health care healthcare fraud and abuse, including but not limited to 18 U.S.C. §§ 286 Sections 286, 287, 1035, 1347 and 287 and 1349, the health care healthcare 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 Medicare statute (“HIPAA”Title XVIII of the Social Security Act), and the Medicaid statute (Title XIX of the Social Security Act); (iii) the Civil Monetary Penalties Lawpatient privacy, 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; data security and beach notification provisions under HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, Act of 2009 (42 U.S.C. §§ §17921 et seq.); the Federal Food, Drug, (iv) comparable state and Cosmetic Act, 21 U.S.C. §§ 301 et seq.local laws; the Public Health Service Act, 42 U.S.C. §§ 201 et seq.; and (v) the regulations promulgated pursuant to such laws; and any similar federal, state, local and foreign laws and regulations of any governmental authority including the United States Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, 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 Healthcare 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 . Neither the Company is not in violation, in nor 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 andsubsidiaries, nor to the Company’s knowledge, no event has occurred their officers, directors, employees, agents, have engaged in activities which allowsare, as applicable, cause for false claims liability, civil penalties, or after mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal healthcare program. Neither the Company nor any of its subsidiaries has received written 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 correspondence of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action (“ProceedingAction”) from any governmental authority including any Regulatory Agency court, arbitrator or any other Governmental Entity or third party alleging a material that any product, operation or activity is in violation of any Health Care Laws or Regulatory Authorizations or limitingHealthcare Laws, suspendingand, modifying, 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; (vi) 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 (“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); (vii) along with its employees, officers and directors, and to the Company’s knowledge, independent contractors and agents, no such Action is not threatened. Neither the Company nor any of its subsidiaries is a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreementsagreement, deferred prosecution agreementsagreement, monitoring agreementsagreement, consent decreesdecree, settlement ordersorder, plans plan of correction or similar agreements agreement with or imposed by any governmental authority including Governmental Entity. Additionally, neither the Company nor any Regulatory Agencies; and (viii) along with of its subsidiaries, nor any of their employees, officers and or directors, and, or to the Company’s knowledge, independent contractors and agents, is or has not been excluded, suspended or debarred from, or otherwise ineligible for from participation in any government health care U.S. state or federal healthcare program or human clinical researchresearch or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Healthcare Laws. The Company: (i) Each of the Company and its Subsidiaries is, and at all times has operated and currently operates its business been, in compliance in all material respects with all applicable provisions of the Health Care Laws, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal health care lawsprogram. For purposes of this Agreement, including Title XVIII of “Health Care Laws” means: (i) the Social Security ActFederal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.), the Public Health Service Act (42 U.S.C. §§ 1395201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-1395lll Kickback Statute (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §Section 1320a-7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. § 1396-1396w-5 (1320a-7h), the Medicaid statute); the Federal Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x); the civil U.S. Civil False Claims Act, Act (31 U.S.C. §§ Section 3729 et seq.; ), the criminal False Claims Act Law (42 U.S.C. § 1320a-7b(a); the ), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. §§ Sections 286 and 287 287, 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. §§ Section 1320d et seq.), (“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, 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, Act (42 U.S.C. §§ Section 17921 et seq.; the 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.; the regulations promulgated pursuant to such laws; and any similar federal, state, local and foreign laws and regulations of any governmental authority including the United States Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, 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”); (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”)statutes; (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 Medicare (Title XVIII of the Company is not in violation, in any material respect, of any term of any such Regulatory AuthorizationsSocial Security Act); (iv) has fulfilled and performed all of its material obligations with respect to the Regulatory Authorizations 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 Medicaid (Title XIX of the rights of the holder of any such Regulatory AuthorizationSocial Security Act); (v) the Controlled Substances Act (21 U.S.C. §§ 801 et seq.) and the regulations promulgated thereunder; and (vi) any and all other applicable health care laws and regulations. Neither the Company nor, to the knowledge of the Company, any subsidiary has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (“Proceeding”) from any court or arbitrator or governmental or regulatory authority including any Regulatory Agency or any other third party alleging a that any product operation or activity is in material violation of any Health Care Laws or Regulatory Authorizations or limitingLaws, suspendingand, modifying, 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; (vi) 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 (“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); (vii) along with its employees, officers and directors, and to the Company’s knowledge, independent contractors and agentsno such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is not threatened. Neither the Company nor, to the knowledge of the Company, any subsidiary 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 or imposed by any governmental authority including or regulatory authority. Additionally, neither the Company, its Subsidiaries nor any Regulatory Agencies; and (viii) along with of its respective employees, officers and directors, and, to the Company’s knowledge, independent contractors and agents, or directors has 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 researchresearch or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Healthcare Laws. The Company: (i) has operated Company and currently operates its business Subsidiaries have been in compliance in all material respects with all applicable provisions of the health care healthcare laws, including Title XVIII of rules and regulations, to the Social Security Actextent they apply to the Company and its current activities, 42 including, without limitation, (i) the FDCA (21 U.S.C. §§ 1395-1395lll (the Medicare statute301 et seq.); Title XIX of (ii) all applicable foreign, federal, state and local healthcare related fraud and abuse laws, including, without limitation, the Social Security Act, federal Anti-kickback Statute (42 U.S.C. §§ 1396-1396w-5 (the Medicaid statute1320a-7b(b); 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 criminal False Claims Act Law (42 U.S.C. § 1320a-7b(a); ), the civil monetary penalties law (42 U.S.C. § 1320a-7a), the exclusion laws (42 U.S.C. § 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), all criminal laws relating to health care healthcare fraud and abuse, including but not limited to 18 U.S.C. §§ 286 Sections 286, 287, 1035, 1347 and 287 and 1349, the health care healthcare 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 Medicare statute (“HIPAA”Title XVIII of the Social Security Act), and the Medicaid statute (Title XIX of the Social Security Act); (iii) the Civil Monetary Penalties Lawpatient privacy, 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; data security and beach notification provisions under HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, Act of 2009 (42 U.S.C. §§ §17921 et seq.); the Federal Food, Drug, (iv) comparable state and Cosmetic Act, 21 U.S.C. §§ 301 et seq.local laws; the Public Health Service Act, 42 U.S.C. §§ 201 et seq.; and (v) the regulations promulgated pursuant to such laws; and any similar federal, state, local and foreign laws and regulations of any governmental authority including the United States Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, 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 Healthcare 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 . Neither the Company is not in violation, in nor 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 andSubsidiaries, nor to the Company’s knowledge, no event has occurred their officers, directors, employees, agents, have engaged in activities which allowsare, as applicable, cause for false claims liability, civil penalties, or after mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal healthcare program. Neither the Company nor any of its Subsidiaries has received written 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 correspondence of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action (“ProceedingAction”) from any governmental authority including any Regulatory Agency court, arbitrator or any other Governmental Entity or third party alleging a material that any product, operation or activity is in violation of any Health Care Laws or Regulatory Authorizations or limitingHealthcare Laws, suspendingand, modifying, 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; (vi) 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 (“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); (vii) along with its employees, officers and directors, and to the Company’s knowledge, independent contractors and agents, no such Action is not threatened. Neither the Company nor any of its Subsidiaries is a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreementsagreement, deferred prosecution agreementsagreement, monitoring agreementsagreement, consent decreesdecree, settlement ordersorder, plans plan of correction or similar agreements agreement with or imposed by any governmental authority including Governmental Entity. Additionally, neither the Company nor any Regulatory Agencies; and (viii) along with of its Subsidiaries, nor any of their employees, officers and or directors, and, or to the Company’s knowledge, independent contractors and agents, is or has not been excluded, suspended or debarred from, or otherwise ineligible for from participation in any government health care U.S. state or federal healthcare program or human clinical researchresearch or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Healthcare Laws. The Company and each of its subsidiaries and, to the Company: ’s knowledge, its directors, officers, employees, and agents (iwhile acting in such capacity) has operated are, and currently operates at all times since January 1, 2011 have been, in material compliance with, all healthcare laws applicable to the Company and each of its business in compliance in all material respects with applicable provisions subsidiaries or any of its products or activities, including, but not limited to, the health care laws, including Title XVIII of the Social Security Act, federal Anti-Kickback Statute (42 U.S.C. §§ 1395-1395lll (the Medicare statute1320a-7b(b); Title XIX of the Social Security Act), 42 U.S.C. §§ 1396-1396w-5 (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 criminal False Claims Act Law (42 U.S.C. § 1320a-7b(a); ), the criminal laws relating to health care fraud and abusefederal Physician Payment Sunshine Act (42 U.S.C. Section 1320a-7h), including 18 the Civil Monetary Penalties Law (42 U.S.C. §§ 286 and 287 and the health care fraud criminal provisions under 1320a-7a), 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; 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 Health Act, Act (42 U.S.C. §§ 17921 et seq.; , the exclusion laws (42 U.S.C. § 1320a-7), the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq.; the Controlled Substances Act, the Public Health Service Act, 42 U.S.C. §§ 201 et seq.; Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), the regulations promulgated pursuant to such laws; , and any similar federalother state or federal law, stateaccreditation standards, local and foreign laws and regulations regulation, memorandum, opinion letter, or other issuance which imposes requirements on the manufacturing, development, testing, labeling, marketing or distribution of any governmental authority including pharmaceutical products, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the United States Food and Drug Administration hiring of the U.S. Department employees or acquisition of Health and Human Services services or supplies from those who have been excluded from government health care programs, quality, safety, privacy, security, licensure, accreditation or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or aspect of providing health care facility Institutional Review Board or pharmaceutical services (collectively, 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 Healthcare Laws”); (ii) , and have not engaged in activities which are, as applicable, prohibited or cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid or any other state or federal health care program. The Company has not received any United States Food and Drug Administration Form 483notification, written notice of adverse finding, warning letter, untitled letter or other correspondence or any other 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 licensesoral communication, 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, including notification of any term of any such Regulatory Authorizations; (iv) has fulfilled and performed all of its material obligations with respect to the Regulatory Authorizations and, to the Company’s knowledge, no event has occurred which allows, pending 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 threatened claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (“Proceeding”) from any governmental authority including any Regulatory Agency authority, including, without limitation, the United States Food and Drug Administration (“FDA”), the Drug Enforcement Administration (“DEA”), the Centers for Medicare & Medicaid Services, the U.S. Department of Justice, or the U.S. Department of Health and Human Services Office of Inspector General, of potential or actual non-compliance by, or liability of, the Company or any other third party alleging a material violation of its subsidiaries under any Health Care Laws or Regulatory Authorizations or limiting, suspending, modifying, 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; (vi) 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 (“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); (vii) along with its employees, officers and directors, and to Laws. To the Company’s knowledge, independent contractors and agents, is not a party there are no facts or circumstances that would reasonably be expected to give rise to liability of the Company or has any ongoing reporting obligations pursuant to of its subsidiaries under 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) along with its employees, officers and directors, and, to the Company’s knowledge, independent contractors and agents, has not been excluded, suspended or debarred from, or otherwise ineligible for participation in any government health care program or human clinical researchHealthcare Laws.

Compliance with Healthcare Laws. The Company and its subsidiaries and, to the Company's knowledge, their respective officers, directors, employees, and independent contractors: (i) has operated during the past four (4) years, have complied with and currently operates its business are in compliance in all material respects with applicable provisions of the health care laws, including Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395lll 1395hhh (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396w-5 1396v (the Medicaid statute); the Federal XxxxAnti-Xxxxxxxx XxxxxxxKickback Statute, 00 X.X.X. 42 U.S.C. § 0000x-0x(x1320a-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-7a1320a-7a and 1320a-7b; the Physician Payments Xxxxxxxx XxxSunshine Act, 00 X.X.X. 42 U.S.C. § 0000x-0x1320a-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 Public Health Service Act, 42 U.S.C. §§ 201 et seq.; the regulations promulgated pursuant to such laws; and any similar federal, state, state and local and foreign laws and regulations of any governmental authority including the United States Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, 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) has 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 or regulatory authority Governmental Entity, including any notified body 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 Governmental Licenses required by any such applicable Health Care Laws (“Regulatory Authorizations”)Laws; (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 during the Company is not in violation, in any material respect, of any term of any such Regulatory Authorizations; past four (iv4) has fulfilled and performed all of its material obligations with respect to the Regulatory Authorizations 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 years have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (“Proceeding”) from any governmental authority including any Regulatory Agency Governmental Entity or any other third party alleging a material violation of any Health Care Laws or Regulatory Authorizations or limiting, suspending, modifying, or revoking any material Regulatory AuthorizationsLaws, and has no knowledge that any governmental authority including any Regulatory Agencies Governmental Entity or any other third party is considering any Proceeding; (viiv) has 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 Regulatory Authorizations 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); (viiv) along with its employees, officers and directors, and to the Company’s knowledge, independent contractors and agents, is 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 authority including any Regulatory AgenciesGovernmental Entity; and (viiivi) along with its employees, officers and or directors, andor, to the Company’s knowledge, independent contractors and agents, has have not been excluded, suspended or debarred from, or otherwise ineligible for participation in any government health care program or human clinical researchresearch during the past four (4) years.

Compliance with Healthcare Laws. The Company: (i) has operated Company and currently operates its business Subsidiaries are, and at all prior times were, in material compliance in with all material respects with applicable provisions federal, state, local and foreign Healthcare Laws. “Healthcare Laws” includes, without limitation, Title XIX of the health care lawsSocial Security Act, including 42 U.S.C. §§ 1396-1396v (the Medicaid statute); Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395lll 1395hhh (the Medicare statute); Title XIX of the Social Security Act, U.S. Anti-Kickback Statute (42 U.S.C. §§ 1396-1396w-5 (the Medicaid statuteSection 1320a-7b(b)); the Federal Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(xU.S. civil monetary penalties law (42 U.S.C. Section 1320a-7a); the civil U.S. Civil False Claims Act, Act (31 U.S.C. §§ Section 3729 et seq.; the criminal False Claims Act 42 U.S.C. 1320a-7b(a); the U.S. criminal false statements law (42 U.S.C. § 1320a-7b(a)); applicable federal, state, local and foreign criminal laws relating to health care fraud and abuse, including 18 U.S.C. §§ Sections 286 and 287 287, and the health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996, HIPAA (42 U.S.C. §§ Section 1320d et seq., (“HIPAA”); the Civil Monetary Penalties Law, U.S. exclusion law (42 U.S.C. §§ 1320a-7aSection 1320a-7); the Physician Payments Xxxxxxxx Xxxstatutes, 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 regulations and Clinical Health Act, 42 U.S.C. §§ 17921 et seq.; the Federal Food, Drugdirectives of applicable government funded or sponsored healthcare programs, and Cosmetic Act, 21 U.S.C. §§ 301 et seq.; the Public Health Service Act, 42 U.S.C. §§ 201 et seq.; the regulations promulgated pursuant to such lawsstatutes; and any similar federal, state, local and foreign laws and regulations of any governmental authority including the United States Food and Drug Administration of the U.S. Department Patient Protection and Affordable Care Act of 2010 (Public Law 111-148), as amended by the U.S. Health Care and Human Services or Education Reconciliation Act of 2010 (Public Law 111-152), and the regulations promulgated thereunder; the U.S. Physician Payments Sunshine Act (42 U.S.C. Section 1320a-7h) and equivalent state transparency laws. Neither the Company nor any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agencyof its Subsidiaries, or health care facility Institutional Review Board (collectivelynor, the “Regulatory Agencies”) applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any knowledge of the Company’s product candidates, (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 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 any Regulatory Agency or any other third party alleging a material violation of any Health Care Laws its Subsidiaries’ officers, directors or Regulatory Authorizations or limiting, suspending, modifying, 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; managing employees (vi) 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 (“Reports”) and that all such Reports were materially complete and correct on the date filed (or were materially corrected or supplemented by a subsequent submissiondefined in 42 U.S.C. § 1320a-5(b); (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) along with its employees, officers and directors, and, to the Company’s knowledge, independent contractors and agents, has not been excluded, suspended or debarred from, or otherwise ineligible for from participation in any government national or regional health care program or human clinical researchmade subject to any pending or, to the knowledge of the Company, threatened or contemplated action which could reasonably be expected to result in such exclusion, suspension or debarment.

Compliance with Healthcare Laws. The Company: (i) has operated and currently operates its business in compliance in all material respects with applicable provisions of the health care laws, including Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395lll (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396w-5 1396w-6 (the Medicaid statute); the Federal XxxxAnti-Xxxxxxxx XxxxxxxKickback Statute, 00 X.X.X. 42 U.S.C. § 0000x-0x(x1320a-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. §§ 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; the Physician Payments Xxxxxxxx XxxSunshine Act, 00 X.X.X. 42 U.S.C. § 0000x-0x1320a-7h; the exclusion law, 42 U.S.C. § 1320a-7; HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, 42 U.S.C. §§ 17921 et seq.; the 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.; the regulations promulgated pursuant to such laws; and any similar federal, state, local and foreign laws and regulations of any governmental authority including the United States Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, 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”); (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 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 any Regulatory Agency or any other third party alleging a material violation of any Health Care Laws or Regulatory Authorizations or limiting, suspending, modifying, 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; (vi) 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 (“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); (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) along with its employees, officers and directors, and, to the Company’s knowledge, independent contractors and agents, has not been excluded, suspended or debarred from, or otherwise ineligible for participation in any government health care program or human clinical research.

Compliance with Healthcare Laws. The Company and its subsidiary and, to the Company: ’s knowledge, its directors, officers, employees, and agents (iwhile acting in such capacity) has operated are, and currently operates at all times have been, in material compliance with, all healthcare laws applicable to the Company and its business in compliance in all material respects with applicable provisions subsidiary or any of its products or activities, including, but not limited to, the health care laws, including Title XVIII of the Social Security Act, federal Anti-Kickback Statute (42 U.S.C. §§ 1395-1395lll (the Medicare statute1320a-7b(b); Title XIX of the Social Security Act), 42 U.S.C. §§ 1396-1396w-5 (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 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. §§ 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; 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 Health Act, 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 Service Services Act, 42 U.S.C. §§ 201 et seq.; 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, statewhich imposes requirements on the manufacturing, local and foreign laws and regulations development, testing, labeling, marketing or distribution of any governmental authority including pharmaceutical products, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the United States Food and Drug Administration hiring of the U.S. Department employees or acquisition of Health and Human Services services or supplies from those who have been excluded from government health care programs, quality, safety, privacy, security, licensure, accreditation or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or aspect of providing health care facility Institutional Review Board or pharmaceutical services (collectively, 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 Healthcare Laws”); (ii) , and have not engaged in activities which are, as applicable, prohibited or cause for false claim liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid or any other state or federal health care program. The Company has not received any United States Food and Drug Administration Form 483notification, written notice of adverse finding, warning letter, untitled letter or other correspondence or any other 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 licensescommunication, 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, including notification of any term of any such Regulatory Authorizations; (iv) has fulfilled and performed all of its material obligations with respect to the Regulatory Authorizations and, to the Company’s knowledge, no event has occurred which allows, pending 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 threatened claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (“ProceedingAction”) from any court, arbitrator, third-party, or governmental authority including any Regulatory Agency or any other third party alleging a material violation 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 subsidiary under any Health Care Laws or Regulatory Authorizations or limiting, suspending, modifying, 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; (vi) 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 (“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); (vii) along with its employees, officers and directorsLaws, 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 knowledge of correction or similar agreements with or imposed by any governmental authority including any Regulatory Agencies; and (viii) along with its employees, officers and directors, and, to the Company’s knowledge, independent contractors and agents, has not been excluded, suspended or debarred from, or otherwise ineligible for participation in any government health care program or human clinical researchno such Action is threatened.

Compliance with Healthcare Laws. The CompanyExcept as described in the Registration Statement or the Prospectus Supplement, and except as would not, individually or in the aggregate, have or may reasonably be expected to have a Material Adverse Effect: (i) has operated the Company’s and currently operates each of its Subsidiaries’ business practices have been structured in a manner designed to comply with state, federal and foreign laws applicable to the Company and its Subsidiaries respective businesses, and the Company and its Subsidiaries are in compliance in all material respects 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. § 1395-1395lll 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. §§ 1396-1396w-5 1395nn), the U.S. Physician Payments Sunshine Act (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§ 1320a-7h); the criminal laws relating to health care fraud and abuse, including 18 U.S.C. §§ 286 §286, 287, 1347, 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-7a1320a-7), Medicare, Title XVIII of the Social Security Act, and Medicaid, Title XIX of the Social Security Act, and the regulations promulgated pursuant to such statutes; the Physician Payments Xxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; 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, Act (42 U.S.C. §§ 17921 et seq.; the 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.; the regulations promulgated pursuant to such laws; thereunder and any similar federal, state, local and foreign laws and regulations of any governmental authority including the United States Food and Drug Administration of the state or non-U.S. Department of Health and Human Services or any committee counterpart thereof or from any other U.S. law or foreign government regulation the purpose of which is to protect the privacy of individuals or drug or medical device regulatory agency, or health care facility Institutional Review Board prescribers (collectively, 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”); (ii) has the Company and its Subsidiaries have not received engaged in activities which are cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any United States Food and Drug Administration Form 483, written notice of adverse finding, warning letter, untitled letter other state health care program 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”)federal health care program; (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 neither 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 nor its material obligations with respect to the Regulatory Authorizations 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 Subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (“Proceeding”) from any court or arbitrator or governmental or regulatory authority including any Regulatory Agency or any other third party alleging a material 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 Regulatory Authorizations or limiting, suspending, modifying, or revoking other action threatened; (iv) neither the Company nor any material Regulatory Authorizations, and Subsidiary has no knowledge received written notice that any court or arbitrator or governmental or regulatory authority including 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 Regulatory Agencies such court or any other third party arbitrator or governmental or regulatory authority is considering any Proceedingsuch action; (viv) has 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 Regulatory Authorizations (“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); (viivi) along with neither the Company nor its employees, officers and directors, and to the Company’s knowledge, independent contractors and agents, is not Subsidiaries are a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, plans of correction, settlement orders, plans of correction or similar agreements with or imposed by any governmental authority including any Regulatory Agenciesor regulatory authority; and (viiivii) along with neither the Company, its Subsidiaries nor any of their respective officers, directors, employees, officers and directors, and, to the Company’s knowledge, independent contractors and agents, has not or agents have been excluded, suspended or debarred from, or otherwise ineligible for from participation in any government U.S. federal health care program or human clinical researchresearch or, to the Company’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 CompanyCompany and its subsidiaries are, and at all relevant times have been, in compliance with all Healthcare Laws (as defined below) in all material respects. For purposes of this Agreement, “Healthcare Laws” means: (i) has operated and currently operates its business in compliance in all material respects with applicable provisions of the health care Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) and the applicable regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign healthcare laws, including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the federal civil False Claims Act (31 U.S.C. Section 3729 et seq.), the federal criminal False Claims Law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the U.S. Physician Payments Sunshine Act (42 U.S.C. Section 1320a-7h), all criminal laws relating to healthcare fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, the healthcare fraud criminal provisions under HIPAA (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C.§ 1320a-7), the exclusion laws (42 U.S.C. § 1320a-7), Medicare (Title XVIII of the Social Security Act), 42 U.S.C. §§ 1395-1395lll Medicaid (the Medicare statute); Title XIX of the Social Security Act), 42 U.S.C. §§ 1396-1396w-5 the Clinical Laboratory Improvement Amendments of 1988 (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. §§ 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; the Physician Payments Xxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; the exclusion law, 42 U.S.C. § 1320a-7263a et seq, each as amended, the regulations promulgated pursuant to such laws; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, Act (42 U.S.C. §§ Section 17921 et seq.; the 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.; the regulations promulgated pursuant to such laws; and any similar federal, state, local and foreign laws and regulations of any governmental authority including the United States Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, 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”); (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 the Patient Protection and performed all Affordable Care Act of 2010 (Public Law 111-148), as amended by the Health Care and Education Affordability Reconciliation Act of 2010 (Public Law 111-152), and the regulations promulgated thereunder; (v) licensure, quality, safety and accreditation requirements under applicable state, local or foreign laws or regulatory bodies; and (vi) and any other local, state, federal, national, supranational and foreign laws, government memorandum, opinion letter, or other issuance which imposes legal requirements on the manufacturing, development, testing, labeling, marketing or distribution of diagnostic products, recordkeeping, quality, safety, privacy, security, licensure, accreditation or any other aspect of producing diagnostic products. Neither the Company, any of its material obligations with respect to the Regulatory Authorizations andsubsidiaries, nor to the Company’s knowledge, no event any of their respective officers, directors, employees or agents have engaged in activities which are, as applicable, cause for liability under a Healthcare Law. Neither the Company nor any of its subsidiaries has occurred which allowsreceived any notification, correspondence 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 written or oral communication, including notification of any such Regulatory Authorization; (v) has not received notice of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (“Proceeding”) from any governmental authority including any Regulatory Agency authority, including, without limitation, the United States Food and Drug Administration (“FDA”), the Drug Enforcement Administration (“DEA”), the Centers for Medicare & Medicaid Services, the U.S. Department of Justice, or the U.S. Department of Health and Human Services Office of Inspector General, of potential or actual non-compliance by, or liability of, the Company or any of its subsidiaries under any Healthcare Laws nor, to the Company’s knowledge, is any such claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other third party alleging a material violation of any Health Care Laws or Regulatory Authorizations or limiting, suspending, modifying, or revoking any material Regulatory Authorizations, action threatened. The Company and has no knowledge that any governmental authority including any Regulatory Agencies or any other third party is considering any Proceeding; (vi) has 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 Regulatory Authorizations (“Reports”) Healthcare 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); (vii) along with . Neither the Company nor any of its employees, officers and directors, and to the Company’s knowledge, independent contractors and agents, subsidiaries 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 or regulatory authority. Additionally, neither the Company, any Regulatory Agencies; and (viii) along with of its employees, officers and directors, andsubsidiaries nor, to the knowledge of the Company’s knowledge, independent contractors and agentsany of their respective employees, officers, directors, or agents has not been excluded, suspended or debarred from, or otherwise ineligible for from participation in any government health care U.S. federal healthcare program or human clinical researchresearch 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 Healthcare Laws. The Company: : (i) has operated and currently operates its business in compliance in all material respects with applicable provisions of the health care laws, including Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395lll (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396w-5 1396w-6 (the Medicaid statute); the Federal XxxxAnti-Xxxxxxxx XxxxxxxKickback Statute, 00 X.X.X. 42 U.S.C. § 0000x-0x(x1320a-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. §§ 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; the Physician Payments Xxxxxxxx XxxSunshine Act, 00 X.X.X. 42 U.S.C. § 0000x-0x1320a-7h; the exclusion law, 42 U.S.C. § 1320a-7; HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, 42 U.S.C. §§ 17921 et seq.; the 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.; the regulations promulgated pursuant to such laws; and any similar federal, state, local and foreign laws and regulations of any governmental authority including the United States Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, 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”); (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 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 any Regulatory Agency or any other third party alleging a material violation of any Health Care Laws or Regulatory Authorizations or limiting, suspending, modifying, 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; (vi) 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 (“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); (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) along with its employees, officers and directors, and, to the Company’s knowledge, independent contractors and agents, has not been excluded, suspended or debarred from, or otherwise ineligible for participation in any government health care program or human clinical research.

Compliance with Healthcare Laws. The Company: (i) has operated Company and currently operates its business subsidiaries have been in compliance in all material respects with all applicable provisions of the health care healthcare laws, including Title XVIII of rules and regulations, to the Social Security Actextent they apply to the Company and its current activities, 42 including, without limitation, (i) the FDCA (21 U.S.C. §§ 1395-1395lll (the Medicare statute301 et seq.); Title XIX of (ii) all applicable foreign, federal, state and local healthcare related fraud and abuse laws, including, without limitation, the Social Security Act, federal Anti-kickback Statute (42 U.S.C. §§ 1396-1396w-5 (the Medicaid statute1320a-7b(b); 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 criminal False Claims Act Law (42 U.S.C. § 1320a-7b(a); ), the civil monetary penalties law (42 U.S.C. § 1320a-7a), the exclusion laws (42 U.S.C. § 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), all criminal laws relating to health care healthcare fraud and abuse, including but not limited to 18 U.S.C. §§ 286 Sections 286, 287, 1035, 1347 and 287 and 1349, the health care healthcare 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 Medicare statute (“HIPAA”Title XVIII of the Social Security Act), and the Medicaid statute (Title XIX of the Social Security Act); (iii) the Civil Monetary Penalties Lawpatient privacy, 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; data security and beach notification provisions under HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (the “HITECH Act, ”) (42 U.S.C. §§ §17921 et seq.); the Federal Food, Drug, (iv) comparable state and Cosmetic Act, 21 U.S.C. §§ 301 et seq.local laws; the Public Health Service Act, 42 U.S.C. §§ 201 et seq.; and (v) the regulations promulgated pursuant to such laws; and any similar federal, state, local and foreign laws and regulations of any governmental authority including the United States Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, 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 Healthcare 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 . Neither the Company is not in violation, in nor 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 andsubsidiaries, nor to the Company’s knowledge, no event has occurred their officers, directors, employees, agents, have engaged in activities which allowsare, as applicable, cause for false claims liability, civil penalties, or after mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal healthcare program. Neither the Company nor any of its subsidiaries has received written 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 correspondence of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action (“ProceedingAction”) from any governmental authority including any Regulatory Agency court, arbitrator or any other Governmental Entity or third party alleging a material that any product, operation or activity is in violation of any Health Care Laws or Regulatory Authorizations or limitingHealthcare Laws, suspendingand, modifying, 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; (vi) 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 (“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); (vii) along with its employees, officers and directors, and to the Company’s knowledge, independent contractors and agents, no such Action is not threatened. Neither the Company nor any of its subsidiaries is a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreementsagreement, deferred prosecution agreementsagreement, monitoring agreementsagreement, consent decreesdecree, settlement ordersorder, plans plan of correction or similar agreements agreement with or imposed by any governmental authority including Governmental Entity. Additionally, neither the Company nor any Regulatory Agencies; and (viii) along with of its subsidiaries, nor any of their employees, officers and or directors, and, or to the Company’s knowledge, independent contractors and agents, is or has not been excluded, suspended or debarred from, or otherwise ineligible for from participation in any government health care U.S. state or federal healthcare program or human clinical researchresearch or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Healthcare Laws. The (a) For the past five (5) years, the Company, and to the Company’s Knowledge, its officers, directors, employees and independent contractors, in their capacity as such, are and have been, in material compliance with all Applicable Laws relating to healthcare regulatory matters (collectively, the “Healthcare Laws”) that are applicable to the business of the Company, including: (i) has operated and currently operates its business Laws governing participation in compliance in all material respects with applicable provisions of the health care laws, including Medicare (Title XVIII of the Social Security Act), 42 U.S.C. §§ 1395-1395lll Medicaid (the Medicare statute); Title XIX of the Social Security Act), and other federal and state healthcare programs defined in 42 U.S.C. §§ 1396-1396w-5 1320a-7b(f) (the Medicaid statutecollectively, “Federal Healthcare Programs”); (ii) HIPAA; (iii) Laws governing the Federal Xxxxcorporate practice of medicine; (iv) Laws relating to kickbacks and self-Xxxxxxxx Xxxxxxxreferrals, 00 X.X.X. including (A) the federal Anti-Kickback Statute (42 U.S.C. § 0000x-0x(x1320a-7b(b); ), (B) the civil False Claims Act, Act (31 U.S.C. §§ 3729 et seq.; ), (C) the criminal Beneficiary Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), (D) the administrative False Claims Act Law (42 U.S.C. § 1320a-7b(a); the criminal laws relating to health care fraud and abuse, including 18 U.S.C. §§ 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; the Physician Payments Xxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; E) the exclusion law, Laws (42 U.S.C. § 1320a-7; HIPAA), as amended by (F) the Health Information Technology for Economic and Clinical Health Act, civil monetary penalty Laws (42 U.S.C. §§ 17921 et seq.; 1320a-7a), (G) the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq.; the Public Health Service Act, Xxxxx Law (42 U.S.C. §§ 201 et seq.; 1395nn), (H) the regulations promulgated pursuant to such lawsfederal Sunshine Act (42 U.S.C. § 1320a-7h) and (I) any other Applicable Laws imposed or enforced by HHS; and (v) any similar federal, state, state or local and foreign laws and regulations of any governmental authority including Laws. (b) Without limiting the United States Food and Drug Administration generality of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agencyforegoing, or health care facility Institutional Review Board for the past five (collectively5) years, the “Regulatory Agencies”) applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any none of the Company’s product candidates, or, to the Knowledge of the Company, any officer, director, managing employee, agent (collectively as those terms are defined in 42 C.F.R. § 1001.1001) or healthcare professional of the Company: (i) is or has been a party to a corporate integrity agreement or Certificate of Compliance Agreement with the Office of Inspector General (“Health Care LawsOIG”)) or similar government-mandated compliance program; (ii) has not received any United States Food and Drug Administration Form 483, written notice of adverse finding, warning letter, untitled letter continuing material reporting obligations pursuant to a settlement agreement or other correspondence or written notice from remedial measure entered into with 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”)Governmental Authority; (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 has been served with or received any search warrants, subpoenas or civil investigative demands of which the Company is not in violationthe subject of such search warrants, in subpoenas or civil investigative demands from any material respect, of any term of any such Regulatory AuthorizationsGovernmental Authority; (iv) has fulfilled and performed all been debarred, excluded or suspended from participation, has received a written notice of its material obligations their exclusion, suspension or debarment from participation or has been threatened with respect to the Regulatory Authorizations andexclusion, to the Company’s knowledge, no event has occurred which allows, suspension or after notice or lapse of time would allow, revocation or termination thereof or results debarment from participation in any other material impairment of the rights of the holder of federal or state healthcare program or subject to a formal disciplinary action by any such Regulatory Authorizationpayor or Governmental Authority; (v) has not received notice had a civil monetary penalty assessed against it, him or her under Section 1128A of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (“Proceeding”) from any governmental authority including any Regulatory Agency or any other third party alleging a material violation of any Health Care Laws or Regulatory Authorizations or limiting, suspending, modifying, 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 Proceedingthe Social Security Act; (vi) is currently or 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 (“Reports”) and that all such Reports were materially complete and correct been listed on the date filed (United States General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; or were materially corrected or supplemented by a subsequent submission); (vii) along has been convicted of, or entered into any settlement or reformation agreement with its employeesany Governmental Authority to avoid conviction of, officers and directors, and any criminal offense relating to the Company’s knowledgedelivery of any item or service under a Federal Healthcare Program or had a civil monetary penalty assessed against them under Section 1128A of the Social Security Act or any regulations promulgated thereunder. (c) The Company has adopted a code of ethics and has an operational healthcare compliance program, materially covering and implementing the seven elements of an effective compliance program described in the Compliance Program Guidance published by the HHS OIG, which governs all employees and contractors, including sales representatives and their interactions with healthcare providers. (d) As required by applicable Healthcare Laws, the Company has (i) verified that all employees providing clinical services, if any, have valid and current licenses, permits and credentials, (ii) conducted criminal background checks on all applicable employees and independent contractors and agents(iii) screened all officers, 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) along with its employees, officers and directors, and, to the Company’s knowledge, employees and independent contractors and agents, has not been excluded, suspended or debarred from, or otherwise ineligible for participation in any government health care program or human clinical researchusing the HHS/OIG List of Excluded Individuals/Entities.

Compliance with Healthcare Laws. The CompanyExcept as described in the Registration Statement or the Prospectus Supplement, and except as would not, individually or in the aggregate, have or may reasonably be expected to have a Material Adverse Effect: (i) has operated the Company’s and currently operates each of its Subsidiaries’ business practices have been structured in a manner designed to comply with state, federal and foreign laws applicable to the Company and its Subsidiaries respective businesses, and the Company and its Subsidiaries are in compliance in all material respects 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. § 1395-1395lll 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. §§ 1396-1396w-5 1395nn), the U.S. Physician Payments Sunshine Act (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§ 1320a-7h); the criminal laws relating to health care fraud and abuse, including 18 U.S.C. §§ 286 §286, 287, 1347, 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-7a1320a-7), Medicare, Title XVIII of the Social Security Act, and Medicaid, Title XIX of the Social Security Act, and the regulations promulgated pursuant to such statutes; the Physician Payments Xxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; 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, Act (42 U.S.C. §§ 17921 et seq.; the 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.; the regulations promulgated pursuant to such laws; thereunder and any similar federal, state, local and foreign laws and regulations of any governmental authority including the United States Food and Drug Administration of the state or non-U.S. Department of Health and Human Services or any committee counterpart thereof or from any other U.S. law or foreign government regulation the purpose of which is to protect the privacy of individuals or drug or medical device regulatory agency, or health care facility Institutional Review Board prescribers (collectively, 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”); (ii) has the Company and its Subsidiaries have not received engaged in activities which are cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any United States Food and Drug Administration Form 483, written notice of adverse finding, warning letter, untitled letter other state health care program 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”)federal health care program; (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 neither 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 nor its material obligations with respect to the Regulatory Authorizations 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 Subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (“Proceeding”) from any court or arbitrator or governmental or regulatory authority including any Regulatory Agency or any other third party alleging a material 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 Regulatory Authorizations other action threatened; (iv) neither the Company nor any Subsidiary has received written notice that any court or limitingarbitrator or governmental or regulatory authority has taken, suspendingis taking or intends to take action to limit, modifyingsuspend, modify or revoking revoke applicable Material Permits or has any material Regulatory Authorizations, and has no knowledge that any such court or arbitrator or governmental or regulatory authority including any Regulatory Agencies or any other third party is considering any Proceedingsuch action; (viv) has 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 Regulatory Authorizations (“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); (viivi) along with neither the Company nor its employees, officers and directors, and to the Company’s knowledge, independent contractors and agents, is not Subsidiaries are a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, plans of correction, settlement orders, plans of correction or similar agreements with or imposed by any governmental authority including any Regulatory Agenciesor regulatory authority; and (viiivii) along with neither the Company, its Subsidiaries nor any of their respective officers, directors, employees, officers and directors, and, to the Company’s knowledge, independent contractors and agents, has not or agents have been excluded, suspended or debarred from, or otherwise ineligible for from participation in any government U.S. federal health care program or human clinical researchresearch or, to the Company’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 (a) For the past five (5) years, the Company and to the Company’s Knowledge, its officers, managers, employees, or independent contractors, in their capacity as such, are and have been, in material compliance with all Applicable Laws relating to healthcare regulatory matters (collectively, the “Healthcare Laws”), including, to the extent applicable: (i) has operated and currently operates its business Laws governing participation in compliance in all material respects with applicable provisions of the health care laws, including Medicare (Title XVIII of the Social Security Act), 42 U.S.C. §§ 1395-1395lll Medicaid (the Medicare statute); Title XIX of the Social Security Act), and other federal and state healthcare programs defined in 42 U.S.C. §§ 1396-1396w-5 1320a-7b(f) (the Medicaid statutecollectively, “Federal Healthcare Programs”); (ii) HIPAA; (iii) Laws governing the Federal Xxxxcorporate practice of medicine; (iv) Laws relating to kickbacks and self-Xxxxxxxx Xxxxxxxreferrals, 00 X.X.X. including (A) the federal Anti-Kickback Statute (42 U.S.C. § 0000x-0x(x1320a-7b(b); ), (B) the civil False Claims Act, Act (31 U.S.C. §§ 3729 et seq.; ), (C) the criminal Beneficiary Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), (D) the administrative False Claims Act Law (42 U.S.C. § 1320a-7b(a); the criminal laws relating to health care fraud and abuse, including 18 U.S.C. §§ 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; the Physician Payments Xxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; E) the exclusion law, Laws (42 U.S.C. § 1320a-7; HIPAA), as amended by (F) the Health Information Technology for Economic and Clinical Health Act, civil monetary penalty Laws (42 U.S.C. §§ 17921 et seq.; 1320a-7a), (G) the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq.; the Public Health Service Act, Xxxxx Law (42 U.S.C. §§ 201 et seq.; 1395nn), (H) the regulations promulgated pursuant to such lawsfederal Sunshine Act (42 U.S.C. § 1320a-7h) and (I) any other Applicable Laws imposed or enforced by HHS; and (v) any similar federal, state, state or local and foreign laws and regulations of any governmental authority including Laws. (b) Without limiting the United States Food and Drug Administration generality of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agencyforegoing, or health care facility Institutional Review Board for the past five (collectively5) years, the “Regulatory Agencies”) applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any none of the Company’s product candidates, or, to the Knowledge of the Company, any managing employee, agent (collectively as those terms are defined in 42 C.F.R. § 1001.1001), officer, manager or healthcare professional of the Company: (i) is or has been a party to a corporate integrity agreement or Certificate of Compliance Agreement with the Office of Inspector General (“Health Care LawsOIG”)) or similar government-mandated compliance program; (ii) has not received any United States Food and Drug Administration Form 483, written notice of adverse finding, warning letter, untitled letter continuing material reporting obligations pursuant to a settlement agreement or other correspondence or written notice from remedial measure entered into with 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”)Governmental Authority; (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 has been served with or received any search warrants, subpoenas or civil investigative demands of which the Company is not in violationthe subject of such search warrants, in subpoenas or civil investigative demands from any material respect, of any term of any such Regulatory AuthorizationsGovernmental Authority; (iv) has fulfilled and performed all been debarred, excluded or suspended from participation, has received a written notice of its material obligations their exclusion, suspension or debarment from participation or has been threatened with respect to the Regulatory Authorizations andexclusion, to the Company’s knowledge, no event has occurred which allows, suspension or after notice or lapse of time would allow, revocation or termination thereof or results debarment from participation in any other material impairment of the rights of the holder of federal or state healthcare program or subject to a formal disciplinary action by any such Regulatory Authorizationpayor or Governmental Authority; (v) has not received notice had a civil monetary penalty assessed against it, him or her under Section 1128A of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (“Proceeding”) from any governmental authority including any Regulatory Agency or any other third party alleging a material violation of any Health Care Laws or Regulatory Authorizations or limiting, suspending, modifying, 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 Proceedingthe Social Security Act; (vi) is currently or 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 (“Reports”) and that all such Reports were materially complete and correct been listed on the date filed (United States General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; or were materially corrected or supplemented by a subsequent submission); (vii) along has been convicted of, or entered into any settlement or reformation agreement with its employeesany Governmental Authority to avoid conviction of, officers any criminal offense relating to the delivery of any item or service under a Federal Healthcare Program or had a civil monetary penalty assessed against them under Section 1128A of the Social Security Act or any regulations promulgated thereunder. (c) The Company has adopted a code of ethics and directorshas an operational healthcare compliance program, materially covering and implementing the seven elements of an effective compliance program described in the Compliance Program Guidance for the Durable Medical Equipment, Prosthetics, Orthotics, and to Supply Industry published by the Company’s knowledgeHHS OIG, which governs all employees and contractors, including sales representatives and their interactions with healthcare providers. (d) To the extent required by applicable Healthcare Laws, the Company has (i) verified that all employees providing clinical services, if any, have valid and current licenses, permits and credentials, (ii) conducted criminal background checks on all applicable employees and independent contractors and agents(iii) screened all officers, is not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreementsmanagers, 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; employees and (viii) along with its employees, officers and directors, and, to the Company’s knowledge, independent contractors and agents, has not been excluded, suspended or debarred from, or otherwise ineligible for participation in any government health care program or human clinical researchusing the HHS/OIG List of Excluded Individuals/Entities.

Compliance with Healthcare Laws. The CompanyCompany is, and during 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 result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) has operated the Federal Food, Drug, and currently operates its business in compliance in Cosmetic Act (21 U.S.C. Section 301 et seq.); (ii) all material respects with applicable provisions of the federal, state, local and foreign health care fraud and abuse laws, including Title XVIII of including, without limitation, the Social Security Act, federal Anti-Kickback Statute (42 U.S.C. §§ 1395-1395lll (Section 1320a-7b(b)), the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396w-5 (the Medicaid statute); the Federal Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x); 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. §§ Section 1320a-7a; ), the exclusion law (42 U.S.C. Section 1320a-7), the federal Physician Payments Xxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; the exclusion law, Sunshine Act (42 U.S.C. § 1320a-7Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, 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; the Public Health Service Act, 42 U.S.C. §§ 201 et seq.; 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, stateindividually or in the aggregate, local and foreign laws and regulations of any governmental authority including to result in a Material Adverse Effect, during the United States Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board last three (collectively3) years, 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”); (ii) Company 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 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, subpoena, civil investigative demand, action, suit, compliant (including a qui tam complaint), proceeding, hearing, enforcement, investigation, inquiry, arbitration or other action (“Proceeding”) from any court or arbitrator or governmental authority including any Regulatory Agency or any other third party alleging a material that any product, operation, or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, subpoena, civil investigative demand, action, suit, complaint (including a qui tam complaint), proceeding, hearing, enforcement, investigation, inquiry, arbitration or Regulatory Authorizations other action threatened. Except as would not reasonably be expected, individually or limitingin the aggregate, suspendingto result in a Material Adverse Effect, modifyingduring the last three (3) years, 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; (vi) 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 Regulatory Authorizations (“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); (vii) along with its employees, officers and directors. The Company is not, and to has not during the Company’s knowledgelast three (3) years been, 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 authority. During the last three (3) years, neither the Company nor any Regulatory Agencies; and (viii) along with of its employees, officers and officers, directors, andor, to the Company’s knowledge, independent contractors and agents, has not have been excluded, suspended or debarred from, or otherwise ineligible for from participation in any government U.S. federal health care program or human clinical researchresearch or, to the knowledge 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 contractors: (i) has operated during the past four (4) years, have complied with and currently operates its business are in compliance in all material respects with applicable provisions of the health care laws, including Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395lll 1395hhh (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396w-5 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 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-7a1320a-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 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 Public Health Service Act, 42 U.S.C. §§ 201 et seq.; the regulations promulgated pursuant to such laws; and any similar federal, state, state and local and foreign laws and regulations of any governmental authority including the United States Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, 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) has 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 or regulatory authority Governmental Entity, including any notified body 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 Governmental Licenses required by any such applicable Health Care Laws (“Regulatory Authorizations”)Laws; (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 during the Company is not in violation, in any material respect, of any term of any such Regulatory Authorizations; past four (iv4) has fulfilled and performed all of its material obligations with respect to the Regulatory Authorizations 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 years have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (“Proceeding”) from any governmental authority including any Regulatory Agency Governmental Entity or any other third party alleging a material violation of any Health Care Laws or Regulatory Authorizations or limiting, suspending, modifying, or revoking any material Regulatory AuthorizationsLaws, and has no knowledge that any governmental authority including any Regulatory Agencies Governmental Entity or any other third party is considering any Proceeding; (viiv) has 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 Regulatory Authorizations 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); (viiv) along with its employees, officers and directors, and to the Company’s knowledge, independent contractors and agents, is 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 authority including any Regulatory AgenciesGovernmental Entity; and (viiivi) along with its employees, officers and or directors, andor, to the Company’s knowledge, independent contractors and agents, has have not been excluded, suspended or debarred from, or otherwise ineligible for participation in any government health care program or human clinical researchresearch during the past four (4) years.

Compliance with Healthcare Laws. The Company: (i) has operated and currently operates its business in compliance in all material respects with applicable provisions of the health care laws, including Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395lll (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396w-5 (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. §§ 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; 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 Health Act, 42 U.S.C. §§ 17921 et seq.; the Federal Food, DrugCompany is, and Cosmetic Actat all relevant times has been, 21 U.S.C. §§ 301 et seq.; in material compliance with all applicable Health Care Laws (as defined below) to the Public Health Service Act, 42 U.S.C. §§ 201 et seq.; the regulations promulgated pursuant to such laws; and any similar federal, state, local and foreign laws and regulations of any governmental authority including the United States Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) extent applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any of product manufactured or distributed by the Company’s product candidates, (collectively except where the failure to comply 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) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the 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 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the Xxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vi) all other local, state, federal, national and foreign laws applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company. Neither the Company nor any of its subsidiaries has not received any United States Food and Drug Administration 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) 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 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 court or arbitrator or governmental or regulatory authority including any Regulatory Agency or any other third party alleging a that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or Regulatory Authorizations or limiting, suspending, modifying, or revoking any material Regulatory Authorizations, other action threatened. The Company and has no knowledge that any governmental authority including any Regulatory Agencies or any other third party is considering any Proceeding; (vi) has 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 Regulatory Authorizations (“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 (or were materially corrected or supplemented by a subsequent submission); (vii) along with its employees, officers and directors, and except as would not reasonably be expected to have a Material Adverse Effect. Neither the Company’s knowledge, independent contractors and agents, Company nor any subsidiary is not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreementsagreement, monitoring agreementsagreement, consent decreesdecree, settlement ordersorder, plans of correction or similar agreements agreement with or imposed by any governmental authority including or regulatory authority. Additionally, neither the Company, any Regulatory Agencies; and (viii) along with of its subsidiaries, nor any of its or their respective employees, officers and directorsofficers, anddirectors or, to the Company’s knowledge, independent contractors and agents, has 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 researchresearch or, to Company’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: (i) has operated and currently operates its business in compliance in all material respects with applicable provisions of the health care laws, including Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395lll (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396w-5 1396w-6 (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. §§ 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; 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 Health Act, 42 U.S.C. §§ 17921 et seq.; the 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.; the regulations promulgated pursuant to such laws; and any similar federal, state, local and foreign laws and regulations of any governmental authority including the United States Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, 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”); (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 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 any Regulatory Agency or any other third party alleging a material violation of any Health Care Laws or Regulatory Authorizations or limiting, suspending, modifying, 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; (vi) 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 (“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); (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) along with its employees, officers and directors, and, to the Company’s knowledge, independent contractors and agents, has not been excluded, suspended or debarred from, or otherwise ineligible for participation in any government health care program or human clinical research.

Compliance with Healthcare Laws. The CompanyCompany is, and during 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 result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) has operated the Federal Food, Drug, and currently operates its business in compliance in Cosmetic Act (21 U.S.C. Section 301 et seq.); (ii) all material respects with applicable provisions of the federal, state, local and foreign health care fraud and abuse laws, including Title XVIII of including, without limitation, the Social Security Act, federal Anti-Kickback Statute (42 U.S.C. §§ 1395-1395lll (Section 1320a-7b(b)), the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396w-5 (the Medicaid statute); the Federal Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x); 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. §§ Section 1320a-7a; ), the exclusion law (42 U.S.C. Section 1320a-7), the federal Physician Payments Xxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; the exclusion law, Sunshine Act (42 U.S.C. § 1320a-7Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, 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; the Public Health Service Act, 42 U.S.C. §§ 201 et seq.; 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, stateindividually or in the aggregate, local and foreign laws and regulations of any governmental authority including to result in a Material Adverse Effect, during the United States Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board last three (collectively3) years, 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”); (ii) Company 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 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, subpoena, civil investigative demand, action, suit, compliant (including a qui tam complaint), proceeding, hearing, enforcement, investigation, inquiry, arbitration or other action (“Proceeding”) from any court or arbitrator or governmental authority including any Regulatory Agency or any other third party alleging a material that any product, operation, or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, subpoena, civil investigative demand, action, suit, complaint (including a qui tam complaint), proceeding, hearing, enforcement, investigation, inquiry, arbitration or Regulatory Authorizations other action threatened. Except as would not reasonably be expected, individually or limitingin the aggregate, suspendingto result in a Material Adverse Effect, modifyingduring the last three (3) years, 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; (vi) 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 Regulatory Authorizations (“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); (vii) along with its employees, officers and directors. The Company is not, and to has not during the Company’s knowledgelast three (3) years been, 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 authority. During the last three (3) years, neither the Company nor any Regulatory Agencies; and (viii) along with of its respective employees, officers and officers, directors, andor, to the Company’s knowledge, independent contractors and agents, agents has 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 researchresearch or, to the knowledge 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: (i) has operated Company and currently operates its business subsidiaries are and have been, since January 1, 2018, in compliance in with all material respects with applicable provisions of the health care laws, including Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395lll (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396w-5 (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. §§ 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; 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 Health Act, 42 U.S.C. §§ 17921 et seq.; the 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.; the regulations promulgated pursuant to such laws; and any similar federal, state, local and foreign healthcare laws and regulations of any governmental authority including the United States Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) applicable related to the ownership, research, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or and disposal of any of product manufactured or distributed by the Company’s product candidates, including, without limitation (collectively i) the “Health Care Laws”FDCA (21 U.S.C. §§ 301 et seq.); (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 the Public Health Service Act (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”42 U.S.C. §§ 201 et seq.); (iii) possesses all Regulatory Authorizations required applicable foreign, federal, state and local healthcare related fraud and abuse laws, including, without limitation, 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 Law (42 U.S.C. § 1320a-7b(a)), the civil monetary penalties law (42 U.S.C. § 1320a-7a), the exclusion laws (42 U.S.C. § 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), all criminal laws relating to conduct its business as currently conducted healthcare fraud and such Regulatory Authorizations are valid abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1035, 1347 and in full force 1349, the healthcare fraud criminal provisions under the U.S. Health Insurance Portability and effect Accountability Act of 1996 (“HIPAA”) (42 U.S.C. §§1320d et seq.), the Medicare statute (Title XVIII of the Social Security Act), and the Company is not in violationMedicaid statute (Title XIX of the Social Security Act); iv) the patient privacy, data security and beach notification provisions under HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (42 U.S.C. §§17921 et seq.); (v) comparable state and local laws; and (vi) the regulations promulgated pursuant to all such laws (collectively, the “Healthcare Laws”) except, in each case, for such non-compliance as would not, individually or in the aggregate, have a Material Adverse Effect. Since January 1, 2018, neither the Company nor 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 andsubsidiaries, nor to the Company’s knowledge, no event its officers, directors, employees or agents, has occurred engaged in activities which allowsare, as applicable, cause for false claims liability, civil penalties, or after mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal healthcare program. Since January 1, 2018 neither the Company nor any of its subsidiaries has received written 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 correspondence of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action (“ProceedingAction”) from any governmental authority including any court or arbitrator, Governmental Entity, Regulatory Agency or any other third party alleging a material that any Company operation or activity is in violation of any Health Care Laws or Regulatory Authorizations or limitingHealthcare Laws, suspendingand, modifying, 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; (vi) 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 (“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); (vii) along with its employees, officers and directors, and to the Company’s knowledge, independent contractors and agents, no such Action is not pending or threatened in writing. Neither Company nor any of its subsidiaries is a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreementsagreement, deferred prosecution agreementsagreement, monitoring agreementsagreement, consent decreesdecree, settlement ordersorder, plans plan of correction or similar agreements agreement with or imposed by any governmental authority including or regulatory authority. Additionally, neither the Company, nor any Regulatory Agencies; and (viii) along with of its subsidiaries, employees, officers and officers, directors, andor, to the Company’s knowledge, independent contractors and agents, is or has not been excluded, suspended or debarred from, or otherwise ineligible for from participation in any government health care U.S. state or federal healthcare program or human clinical researchresearch or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Healthcare Laws. The CompanyCompany and its subsidiaries: (i) has operated have complied with and currently operates its business are in compliance in all material respects with applicable provisions of the health care laws, including Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395lll 1395hhh (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396w-5 1396v (the Medicaid statute); the Federal XxxxAnti-Xxxxxxxx XxxxxxxKickback Statute, 00 X.X.X. 42 U.S.C. § 0000x-0x(x1320a-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-7a1320a-7a and 1320a-7b; the Physician Payments Xxxxxxxx XxxSunshine Act, 00 X.X.X. 42 U.S.C. § 0000x-0x1320a-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 Public Health Service Act, 42 U.S.C. §§ 201 et seq.; the regulations promulgated pursuant to such laws; and any similar federal, state, state and local and foreign laws and regulations of any governmental authority including the United States Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, 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) has have not received any 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 or regulatory authority Governmental Entity, including any notified body 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 Governmental Licenses required by any such applicable Health Care Laws (“Regulatory Authorizations”)Laws; (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 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 have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (“Proceeding”) from any governmental authority including any Regulatory Agency or any other third party Governmental Entity alleging a material violation of any Health Care Laws or Regulatory Authorizations or limiting, suspending, modifying, or revoking any material Regulatory AuthorizationsLaws, and has no knowledge that any governmental authority including any Regulatory Agencies or any other third party Governmental Entity is considering any Proceeding; (viiv) has 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 Regulatory Authorizations 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); (viiv) along with its employees, officers and directors, and to the Company’s knowledge, independent contractors and agents, is 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 authority including any Regulatory AgenciesGovernmental Entity; and (viiivi) along with its their respective employees, officers and or directors, andor, to the Company’s knowledge, independent contractors and agents, has 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 researchregistry, and have no knowledge that the Company, 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.