Common use of Compliance with Healthcare Laws Clause in Contracts

Compliance with Healthcare Laws. The Company and its subsidiaries have been in compliance in all material respects with all applicable healthcare laws, rules and regulations, to the extent they apply to the Company and its current activities, including, without limitation, (i) the FDCA (21 U.S.C. §§ 301 et seq.); (ii) all 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 healthcare fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1035, 1347 and 1349, the healthcare fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. §§1320d et seq.), the Medicare statute (Title XVIII of the Social Security Act), and the Medicaid statute (Title XIX of the Social Security Act); (iii) 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.); (iv) comparable state and local laws; and (v) the regulations promulgated pursuant to such laws (collectively, the “Healthcare Laws”). Neither the Company nor any of its subsidiaries, nor to the Company’s knowledge, their officers, directors, employees, agents, have engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal healthcare program. Neither the Company nor any of its subsidiaries has received written notice or other correspondence of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action (“Action”) from any court, arbitrator or Governmental Entity or third party alleging that any product, operation or activity is in violation of any Healthcare Laws, and, to the Company’s knowledge, no such Action is threatened. Neither the Company nor any of its subsidiaries is a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreement, monitoring agreement, consent decree, settlement order, plan of correction or similar agreement with or imposed by any Governmental Entity. Additionally, neither the Company nor any of its subsidiaries, nor any of their employees, officers or directors, or to the Company’s knowledge, agents, is or has been excluded, suspended or debarred from participation in any U.S. state or federal healthcare program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Healthcare Laws. The Company Except as described in the Registration Statement, the Time of Sale Prospectus and its subsidiaries have been the Prospectus, and except as would not reasonably be expected, individually or in compliance in all material respects with all applicable healthcare laws, rules and regulationsthe aggregate, to have a Material Adverse Effect, the extent they apply to the Company and its current activities, including, without limitation, Company: (i) has operated and currently operates its business in compliance with applicable provisions of the FDCA (21 health care laws, including Title XVIII of the Social Security Act, 42 U.S.C. §§ 301 et seq.1395-1395hhh (the Medicare statute); (ii) all applicable foreignTitle XIX of the Social Security Act, federal, state and local healthcare related fraud and abuse laws, including, without limitation, the federal Anti-kickback Statute (42 U.S.C. §§ 1320a-7b(b1396-1396v (the Medicaid statute); the Federal Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x), ; the civil False Claims Act (Act, 31 U.S.C. §§ 3729 et seq.), ; the criminal False Claims Law (Act 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 healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1035, 1347 286 and 1349, 287 and the healthcare health care fraud criminal provisions under the U.S. 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. §§1320d et seq.)§ 1320a-7a; the Physician Payments Xxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; the Medicare statute (Title XVIII of the Social Security Act)Exclusion Law, and the Medicaid statute (Title XIX of the Social Security Act)42 U.S.C. § 1320a-7; (iii) 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 (Act, 42 U.S.C. §§§ 17921 et seq.); (iv) comparable state the Federal Food, Drug, and local lawsCosmetic Act, 21 U.S.C. §§ 301 et seq.;; and (v) the regulations promulgated pursuant to such laws; and any similar federal, state and local laws and regulations of any governmental authority including the Regulatory Agencies applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any of the Company’s product candidates, (collectively, collectively the “Healthcare Health Care Laws”). Neither the Company nor ; (ii) has not received any of its subsidiariesFDA Form 483, nor to the Company’s knowledge, their officers, directors, employees, agents, have engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal healthcare program. Neither the Company nor any of its subsidiaries has received written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting non-compliance with (A) any Health Care Laws or (B) or any licenses, approvals, clearances, exemptions, permits, registrations, authorizations, and supplements or amendments thereto required by any such Health Care Laws (“Regulatory Authorizations”); (iii) possesses all Regulatory Authorizations required to conduct its business as currently conducted and such Regulatory Authorizations are valid and in full force and effect and the Company is not in violation, in any material respect, of any term of any such Regulatory Authorizations; (iv) has not received notice of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action (“ActionProceeding”) from any court, arbitrator governmental authority including any Regulatory Agency or Governmental Entity or any other third party alleging that any product, operation or activity is in a material violation of any Healthcare LawsHealth Care Laws or Regulatory Authorizations or limiting, andsuspending, to 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; (v) 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 Company’s knowledge, no such Action date filed (or were materially corrected or supplemented by a subsequent submission); (vii) is threatened. Neither the Company nor any of its subsidiaries is not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreementagreements, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan plans of correction or similar agreement agreements with or imposed by any Governmental Entity. Additionally, neither the Company nor governmental authority including any of Regulatory Agencies; and (viii) along with its subsidiaries, nor any of their employees, officers or and directors, or to the Company’s knowledge, agents, is or has not been excluded, suspended or debarred from from, or otherwise ineligible for participation in any U.S. state or federal healthcare government health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusionresearch.

Compliance with Healthcare Laws. The Company Except as described in the Registration Statement and its subsidiaries have been the Prospectus, and except as would not reasonably be expected, individually or in compliance in all material respects with all applicable healthcare laws, rules and regulationsthe aggregate, to have a Material Adverse Effect, the extent they apply to the Company and its current activities, including, without limitation, Company: (i) has operated and currently operates its business in compliance with applicable provisions of the FDCA (21 health care laws, including Title XVIII of the Social Security Act, 42 U.S.C. §§ 301 et seq.1395-1395hhh (the Medicare statute); (ii) all applicable foreignTitle XIX of the Social Security Act, federal, state and local healthcare related fraud and abuse laws, including, without limitation, the federal Anti-kickback Statute (42 U.S.C. §§ 1320a-7b(b1396-1396v (the Medicaid statute); the Federal Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x), ; the civil False Claims Act (Act, 31 U.S.C. §§ 3729 et seq.), ; the criminal False Claims Law (Act 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 healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1035, 1347 286 and 1349, 287 and the healthcare health care fraud criminal provisions under the U.S. 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. §§1320d et seq.)§ 1320a-7a; the Physician Payments Xxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; the Medicare statute (Title XVIII of the Social Security Act)Exclusion Law, and the Medicaid statute (Title XIX of the Social Security Act)42 U.S.C. § 1320a-7; (iii) 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 (Act, 42 U.S.C. §§§ 17921 et seq.); (iv) comparable state the Federal Food, Drug, and local lawsCosmetic Act, 21 U.S.C. §§ 301 et seq.; and (v) the regulations promulgated pursuant to such laws; and any similar federal, state and local laws and regulations of any governmental authority including the Regulatory Agencies applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any of the Company’s product candidates, (collectively, collectively the “Healthcare Health Care Laws”). Neither the Company nor ; (ii) has not received any of its subsidiariesFDA Form 483, nor to the Company’s knowledge, their officers, directors, employees, agents, have engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal healthcare program. Neither the Company nor any of its subsidiaries has received written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting non-compliance with (A) any Health Care Laws or (B) or any licenses, approvals, clearances, exemptions, permits, registrations, authorizations, and supplements or amendments thereto required by any such Health Care Laws (“Regulatory Authorizations”); (iii) possesses all Regulatory Authorizations required to conduct its business as currently conducted and such Regulatory Authorizations are valid and in full force and effect and the Company is not in violation, in any material respect, of any term of any such Regulatory Authorizations; (iv) has not received notice of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action (“ActionProceeding”) from any court, arbitrator governmental authority including any Regulatory Agency or Governmental Entity or any other third party alleging that any product, operation or activity is in a material violation of any Healthcare LawsHealth Care Laws or Regulatory Authorizations or limiting, andsuspending, to 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; (v) 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 Company’s knowledge, no such Action date filed (or were materially corrected or supplemented by a subsequent submission); (vii) is threatened. Neither the Company nor any of its subsidiaries is not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreementagreements, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan plans of correction or similar agreement agreements with or imposed by any Governmental Entity. Additionally, neither the Company nor governmental authority including any of Regulatory Agencies; and (viii) along with its subsidiaries, nor any of their employees, officers or and directors, or to the Company’s knowledge, agents, is or has not been excluded, suspended or debarred from from, or otherwise ineligible for participation in any U.S. state or federal healthcare government health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusionresearch.

Compliance with Healthcare Laws. The Company Except as described in the Registration Statement, the General Disclosure Package and its subsidiaries have been in compliance in all material respects with all applicable healthcare lawsthe Prospectus, rules and regulations, the Company: (i) to the extent they apply to applicable, has operated and currently operates its business in compliance with applicable provisions of the Company and its current activitieshealth care laws, includingincluding Title XVIII of the Social Security Act, without limitation, (i) the FDCA (21 42 U.S.C. §§ 301 et seq.1395-1395hhh (the Medicare statute); (ii) all applicable foreignTitle XIX of the Social Security Act, federal, state and local healthcare related fraud and abuse laws, including, without limitation, the federal Anti-kickback Statute (42 U.S.C. §§ 1320a-7b(b1396-1396v (the Medicaid statute); the Federal Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x), ; the civil False Claims Act (Act, 31 U.S.C. §§ 3729 et seq.), ; the criminal False Claims Law (Act 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 healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1035, 1347 286 and 1349, 287 and the healthcare health care fraud criminal provisions under the U.S. 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. §§1320d et seq.)§ 1320a-7a; the Physician Payments Xxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; the Medicare statute (Title XVIII of the Social Security Act)exclusion law, and the Medicaid statute (Title XIX of the Social Security Act)42 U.S.C. § 1320a-7; (iii) 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 (Act, 42 U.S.C. §§§ 17921 et seq.); (iv) comparable state the Federal Food, Drug, and local lawsCosmetic Act, 21 U.S.C. §§ 301 et seq.; and (v) the regulations promulgated pursuant to such laws; and any similar federal, state and local laws (collectivelyand regulations of any governmental authority including the Regulatory Agencies applicable to the ownership, the “Healthcare Laws”). Neither the Company nor testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any of its subsidiaries, nor to the Company’s knowledgeproduct candidates, their officers(collectively the “Health Care Laws”) except as would not, directorssingly or in the aggregate, employeesresult in a Material Adverse Effect; (ii) has not received any FDA Form 483, agents, have engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal healthcare program. Neither the Company nor any of its subsidiaries has received written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting non-compliance with (A) any Health Care Laws or (B) or any licenses, approvals, clearances, exemptions, permits, registrations, authorizations, and supplements or amendments thereto required by any such Health Care Laws (“Regulatory Authorizations”); (iii) possesses all Regulatory Authorizations required to conduct its business as currently conducted and such Regulatory Authorizations are valid and in full force and effect and the Company is not in violation in any material respect of any term of any such Regulatory Authorizations; (iv) has not received notice of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action (“ActionProceeding”) from any court, arbitrator governmental authority including any Regulatory Agency or Governmental Entity or any other third party alleging that any product, operation or activity is in a material violation of any Healthcare LawsHealth Care Laws or Regulatory Authorizations or limiting, andsuspending, to 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; (v) 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 Company’s knowledge, no such Action date filed (or were materially corrected or supplemented by a subsequent submission); (vii) is threatened. Neither the Company nor any of its subsidiaries is not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreementagreements, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan plans of correction or similar agreement agreements with or imposed by any Governmental Entity. Additionally, neither the Company nor governmental authority including any of Regulatory Agencies; and (viii) along with its subsidiaries, nor any of their employees, officers or and directors, or to the Company’s knowledge, agents, is or has not been excluded, suspended or debarred from from, or otherwise ineligible for participation in any U.S. state or federal healthcare government health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusionresearch.

Compliance with Healthcare Laws. The Company Except as described in the Registration Statement, the General Disclosure Package and its subsidiaries have been the Prospectus, or except as would not, singly or in compliance the aggregate, reasonably be expected to result in all material respects with all applicable healthcare lawsa Material Adverse Effect, rules and regulations, to the extent they apply to the Company and its current activities, including, without limitation, Company: (i) has operated and currently operates its business in compliance with applicable provisions of the FDCA (21 health care laws, including Title XVIII of the Social Security Act, 42 U.S.C. §§ 301 et seq.1395-1395hhh (the Medicare statute); (ii) all applicable foreignTitle XIX of the Social Security Act, federal, state and local healthcare related fraud and abuse laws, including, without limitation, the federal Anti-kickback Statute (42 U.S.C. §§ 1320a-7b(b1396-1396v (the Medicaid statute); the Federal Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x), ; the civil False Claims Act (Act, 31 U.S.C. §§ 3729 et seq.), ; the criminal False Claims Law (Act 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 healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1035, 1347 286 and 1349, 287 and the healthcare health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 1996, 42 U.S.C. §§ 1320d et seq., (“HIPAA”) (); the Civil Monetary Xxxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; the Criminal False Claims Law 42 U.S.C. §§1320d et seq.), the Medicare statute (Title XVIII of the Social Security Act), and the Medicaid statute (Title XIX of the Social Security Act§ 1320a-7b(a); (iii) the patient privacyPhysician Payments Xxxxxxxx Xxx, data security and beach notification provisions under 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 of 2009 (Act, 42 U.S.C. §§§ 17921 et seq.); (iv) comparable state the Federal Food, Drug, and local lawsCosmetic Act, 21 U.S.C. §§ 301 et seq.; and (v) the regulations promulgated pursuant to such laws; and any similar federal, state and local laws and regulations of any governmental authority including the Regulatory Agencies applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any of the Company’s product candidates, (collectively, collectively the “Healthcare Health Care Laws”). Neither the Company nor any of ; (ii) along with its subsidiariesemployees, nor officers and directors, and to the Company’s knowledge, their officers, directors, employees, independent contractors and agents, have engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal healthcare program. Neither the Company nor any of its subsidiaries has received written notice or other correspondence of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action (“Action”) from any court, arbitrator or Governmental Entity or third party alleging that any product, operation or activity is in violation of any Healthcare Laws, and, to the Company’s knowledge, no such Action is threatened. Neither the Company nor any of its subsidiaries is not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreementagreements, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan plans of correction or similar agreement agreements with or imposed by any Governmental Entity. Additionally, neither the Company nor governmental authority including any of Regulatory Agencies; and (iii) along with its subsidiaries, nor any of their employees, officers or and directors, or and to the Company’s knowledge, independent contractors and agents, is or has not been excluded, suspended or debarred from from, or otherwise ineligible for participation in any U.S. state or federal healthcare government health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusionresearch.

Compliance with Healthcare Laws. The Company Except as described in the Registration Statement, the General Disclosure Package and its subsidiaries have been the Prospectus, or except as would not, singly or in compliance the aggregate, result in all material respects with all applicable healthcare lawsa Material Adverse Effect, rules and regulations, to the extent they apply to the Company and its current activities, including, without limitation, Company: (i) has operated and currently operates its business in compliance with applicable provisions of the FDCA (21 health care laws, including Title XVIII of the Social Security Act, 42 U.S.C. §§ 301 et seq.1395-1395hhh (the Medicare statute); (ii) all applicable foreignTitle XIX of the Social Security Act, federal, state and local healthcare related fraud and abuse laws, including, without limitation, the federal Anti-kickback Statute (42 U.S.C. §§ 1320a-7b(b1396-1396v (the Medicaid statute); the Federal Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x), ; the civil False Claims Act (Act, 31 U.S.C. §§ 3729 et seq.), ; the criminal False Claims Law (Act 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 healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1035, 1347 286 and 1349, 287 and the healthcare health care fraud criminal provisions under the U.S. 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. §§1320d et seq.)§ 1320a-7a; the Physician Payments Xxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; the Medicare statute (Title XVIII of the Social Security Act)exclusion law, and the Medicaid statute (Title XIX of the Social Security Act)42 U.S.C. § 1320a-7; (iii) 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 (Act, 42 U.S.C. §§§ 17921 et seq.); (iv) comparable state the Federal Food, Drug, and local lawsCosmetic Act, 21 U.S.C. §§ 301 et seq.; and (v) the Public Health Service Act, 42 U.S.C. §§ 201 et seq.; the regulations promulgated pursuant to such laws; and any similar federal, state and local laws and regulations of any governmental authority including the Regulatory Agencies applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any of the Company’s product candidates, (collectively, collectively the “Healthcare Health Care Laws”). Neither ; (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 nor is not in violation of any term of any such Regulatory Authorizations; (iv) has fulfilled and performed all of its subsidiariesobligations with respect to the Regulatory Authorizations and, nor to the Company’s knowledge, their officers, directors, employees, agents, have engaged in activities no event has occurred which are, as applicable, cause for false claims liability, civil penaltiesallows, or mandatory after notice or permissive exclusion from Medicarelapse of time would allow, Medicaid, revocation or termination thereof or results in any other state or federal healthcare program. Neither impairment of the Company nor rights of the holder of any of its subsidiaries such Regulatory Authorization; (v) has not received written notice or other correspondence of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action (“ActionProceeding”) from any court, arbitrator governmental authority including any Regulatory Agency or Governmental Entity or any other third party alleging that any product, operation or activity is in a violation of any Healthcare LawsHealth Care Laws or Regulatory Authorizations or limiting, andsuspending, to modifying, or revoking any 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 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 complete and correct on the Company’s knowledge, no such Action date filed (or were corrected or supplemented by a subsequent submission); (vii) is threatened. Neither the Company nor any of its subsidiaries is not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreementagreements, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan plans of correction or similar agreement agreements with or imposed by any Governmental Entity. Additionally, neither the Company nor governmental authority including any of Regulatory Agencies; and (viii) along with its subsidiaries, nor any of their employees, officers or and directors, or and to the Company’s knowledge, independent contractors and agents, is or has not been excluded, suspended or debarred from from, or otherwise ineligible for participation in any U.S. state or federal healthcare government health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusionresearch.

Compliance with Healthcare Laws. The Company and its subsidiaries have been in compliance in all material respects with all applicable healthcare laws, rules and regulations, to the extent they apply to the Company and its current activities, including, without limitation, Company: (i) has operated and currently operates its business in compliance with applicable provisions of the FDCA (21 health care laws, including Title XVIII of the Social Security Act, 42 U.S.C. §§ 301 1395 et seq.. (the Medicare statute); (ii) all applicable foreignTitle XIX of the Social Security Act, federal, state and local healthcare related fraud and abuse laws, including, without limitation, the federal Anti-kickback Statute (42 U.S.C. §§ 1320a-7b(b1396 et seq (the Medicaid statute); the 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 Law (Act 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 healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1035, 1347 286 and 1349, 287 and the healthcare health care fraud criminal provisions under HIPAA; the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (Civil Monetary Penalties Law, 42 U.S.C. §§1320d et seq.)§ 1320a-7a; the Physician Payments Xxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; the Medicare statute (Title XVIII of the Social Security Act)exclusion law, and the Medicaid statute (Title XIX of the Social Security Act)42 U.S.C. § 1320a-7; (iii) 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 (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. §§17921 201 et seq.); (iv) comparable state and local lawsClinical Laboratory Improvement Amendments of 1988, 42 U.S.C. § 263a et seq.; and (v) the regulations promulgated pursuant to such laws; and any similar federal, state and local laws (collectivelyand regulations of any governmental authority including the Regulatory Agencies applicable to the ownership, the “Healthcare Laws”). Neither the Company nor testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any of its subsidiaries, nor to the Company’s knowledgeor its subsidiaries’ products or services, their officers(collectively the “Health Care Laws”) except as would not, directorssingly or in the aggregate, employeesresult in a Material Adverse Effect; (ii) has not received any Form FDA-483, agentswritten notice of adverse finding, have engaged in activities which arewarning letter, as applicable, cause for false claims liability, civil penalties, untitled letter or mandatory other written correspondence or permissive exclusion notice from Medicare, Medicaid, any court or arbitrator or governmental or regulatory authority alleging or asserting material non-compliance with (A) any Health Care Laws or (B) or any other state licenses, approvals, clearances, exemptions, permits, registrations, authorizations, and supplements or federal healthcare program. Neither amendments thereto required by any such Health Care Laws (“Regulatory Authorizations”); (iii) possesses all material Regulatory Authorizations required to conduct the business as currently conducted and such Regulatory Authorizations are valid and in full force and effect and the Company nor is not in violation in any material respect of its subsidiaries any term of any such Regulatory Authorizations; (iv) has not received written notice or other correspondence of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action (“ActionProceeding”) from any court, arbitrator governmental authority including any Regulatory Agency or Governmental Entity or third any other third-party alleging that any product, operation or activity is in a material violation of any Healthcare LawsHealth Care Laws or Regulatory Authorizations or limiting, andsuspending, to 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; (v) 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 Company’s knowledge, no such Action date filed (or were materially corrected or supplemented by a subsequent submission); (vii) is threatened. Neither the Company nor any of its subsidiaries is not a party to or has any no ongoing reporting obligations pursuant to any corporate integrity agreementagreements, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan plans of correction or similar agreement agreements with or imposed by any Governmental Entity. Additionally, neither the Company nor governmental authority including any of Regulatory Agencies; and (viii) along with its subsidiaries, nor any of their employees, officers or and directors, or to the Company’s knowledge, agents, is or has not been excluded, suspended or debarred from from, or otherwise ineligible for participation in any U.S. state or federal healthcare government health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusionresearch.

Compliance with Healthcare Laws. The Company Except as described in the Registration Statement, the General Disclosure Package and its subsidiaries have been the Prospectus, or except as would not, singly or in compliance the aggregate, reasonably be expected to result in all material respects with all applicable healthcare lawsa Material Adverse Effect, rules and regulations, to the extent they apply to the Company and its current activities, including, without limitation, Company: (i) has operated and currently operates its business in compliance with applicable provisions of the FDCA (21 health care laws, including Title XVIII of the Social Security Act, 42 U.S.C. §§ 301 et seq.1395-1395hhh (the Medicare statute); (ii) all applicable foreignTitle XIX of the Social Security Act, federal, state and local healthcare related fraud and abuse laws, including, without limitation, the federal Anti-kickback Statute (42 U.S.C. §§ 1320a-7b(b1396-1396v (the Medicaid statute); the Federal Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x), ; the civil False Claims Act (Act, 31 U.S.C. §§ 3729 et seq.), ; the criminal False Claims Law (Act 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 healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1035, 1347 286 and 1349, 287 and the healthcare health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 1996, 42 U.S.C. §§ 1320d et seq., (“HIPAA”) (); the Civil Monetary Xxxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; the Criminal False Claims Law 42 U.S.C. §§1320d et seq.), the Medicare statute (Title XVIII of the Social Security Act), and the Medicaid statute (Title XIX of the Social Security Act§ 1320a-7b(a); (iii) the patient privacyPhysician Payments Xxxxxxxx Xxx, data security and beach notification provisions under 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 of 2009 (Act, 42 U.S.C. §§§ 17921 et seq.); (iv) comparable state the Federal Food, Drug, and local lawsCosmetic Act, 21 U.S.C. §§ 301 et seq.; and (v) the regulations promulgated pursuant to such laws; and any similar federal, state and local laws and regulations of any governmental authority including the Regulatory Agencies applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any of the Company's product candidates, (collectively, collectively the “Healthcare Health Care Laws”). Neither the Company nor any of ; (ii) along with its subsidiariesemployees, nor officers and directors, and to the Company’s knowledge, their officers, directors, employees, independent contractors and agents, have engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal healthcare program. Neither the Company nor any of its subsidiaries has received written notice or other correspondence of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action (“Action”) from any court, arbitrator or Governmental Entity or third party alleging that any product, operation or activity is in violation of any Healthcare Laws, and, to the Company’s knowledge, no such Action is threatened. Neither the Company nor any of its subsidiaries is not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreementagreements, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan plans of correction or similar agreement agreements with or imposed by any Governmental Entity. Additionally, neither the Company nor governmental authority including any of Regulatory Agencies; and (iii) along with its subsidiaries, nor any of their employees, officers or and directors, or and to the Company’s knowledge, independent contractors and agents, is or has not been excluded, suspended or debarred from from, or otherwise ineligible for participation in any U.S. state or federal healthcare government health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusionresearch.

Compliance with Healthcare Laws. The Company and each of its subsidiaries have been subsidiaries: (i) has operated and currently operates its business in compliance in all material respects with applicable provisions of all applicable healthcare health care laws, rules and regulationsincluding Title XVIII of the Social Security Act, to the extent they apply to the Company and its current activities, including, without limitation, (i) the FDCA (21 42 U.S.C. §§ 301 et seq.1395-1395hhh (the Medicare statute); (ii) all applicable foreignTitle XIX of the Social Security Act, federal, state and local healthcare related fraud and abuse laws, including, without limitation, the federal Anti-kickback Statute (42 U.S.C. §§ 1320a-7b(b1396-1396v (the Medicaid statute); the Federal Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x), ; the civil False Claims Act (Act, 31 U.S.C. §§ 3729 et seq.), ; the criminal False Claims Law (Act 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 healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1035, 1347 286 and 1349, 287 and the healthcare health care fraud criminal provisions under the U.S. 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. §§1320d et seq.)§ 1320a-7a and 1320a-7b; the Physician Payments Xxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; the Medicare statute (Title XVIII of the Social Security Act)exclusion law, and the Medicaid statute (Title XIX of the Social Security Act)42 U.S.C. § 1320a-7; (iii) 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 (Act, 42 U.S.C. §§§ 17921 et seq.); (iv) comparable state the Federal Food, Drug, and local lawsCosmetic Act, 21 U.S.C. §§ 301 et seq.; and (v) the Public Health Service Act, 42 U.S.C. §§ 201 et seq.; the regulations promulgated pursuant to such laws; and any similar applicable federal, state, local or foreign laws and regulations of any governmental authority including the Regulatory Agencies applicable to the ownership, testing, development, manufacture, packaging, processing, use, sale, distribution, storage, import, export or disposal of any of the Company’s product candidates (collectively, the “Healthcare Health Care Laws”). Neither ; (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 nor is not in violation, in any material respect, of any term of any such Regulatory Authorizations; (iv) has fulfilled and performed all of its subsidiariesmaterial obligations with respect to the Regulatory Authorizations required to conduct its business as currently conducted and, nor to the Company’s knowledge, their officers, directors, employees, agents, have engaged in activities no event has occurred which are, as applicable, cause for false claims liability, civil penaltiesallows, or mandatory after notice or permissive exclusion from Medicarelapse of time would allow, Medicaid, revocation or termination thereof or results in any other state or federal healthcare program. Neither material impairment of the Company nor rights of the holder of any of its subsidiaries such Regulatory Authorization; (v) has not received written notice or other correspondence of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action (“ActionProceeding”) from any court, arbitrator governmental authority including any Regulatory Agency or Governmental Entity or any other third party alleging that any product, operation or activity is in a material violation of any Healthcare LawsHealth Care Laws or Regulatory Authorizations or limiting, andsuspending, 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”) required to conduct its business as currently conducted and that all such Reports were materially complete and correct on the date filed (or were materially corrected or supplemented by a subsequent submission); (vii) along with its employees, officers and directors, and to the Company’s knowledge, no such Action independent contractors and agents, is threatened. Neither the Company nor any of its subsidiaries is not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreementagreements, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan plans of correction or similar agreement agreements with or imposed by any Governmental Entity. Additionally, neither the Company nor governmental authority including any of Regulatory Agencies; and (viii) along with its subsidiaries, nor any of their employees, officers or and directors, or and to the Company’s knowledge, independent contractors and agents, is or has not been excluded, suspended or debarred from from, or otherwise rendered ineligible for participation in any U.S. state or federal healthcare government health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusionresearch.

Compliance with Healthcare Laws. The Company and each of its subsidiaries have been subsidiaries: (i) has operated and currently operates its business in compliance in all material respects with applicable provisions of all applicable healthcare health care laws, rules and regulationsincluding Title XVIII of the Social Security Act, to the extent they apply to the Company and its current activities, including, without limitation, (i) the FDCA (21 42 U.S.C. §§ 301 et seq.1395-1395hhh (the Medicare statute); (ii) all applicable foreignTitle XIX of the Social Security Act, federal, state and local healthcare related fraud and abuse laws, including, without limitation, the federal Anti-kickback Statute (42 U.S.C. §§ 1320a-7b(b1396-1396v (the Medicaid statute); the Federal Axxx-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 Law (Act 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 healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1035, 1347 286 and 1349, 287 and the healthcare health care fraud criminal provisions under the U.S. 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. §§1320d et seq.)§ 1320a-7a and 1320a-7b; the Physician Payments Sxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; the Medicare statute (Title XVIII of the Social Security Act)exclusion law, and the Medicaid statute (Title XIX of the Social Security Act)42 U.S.C. § 1320a-7; (iii) 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 (Act, 42 U.S.C. §§§ 17921 et seq.); (iv) comparable state the Federal Food, Drug, and local lawsCosmetic Act, 21 U.S.C. §§ 301 et seq.; and (v) the Public Health Service Act, 42 U.S.C. §§ 201 et seq.; the regulations promulgated pursuant to such laws; and any similar applicable federal, state, local or foreign laws and regulations of any governmental authority including the Regulatory Agencies applicable to the ownership, testing, development, manufacture, packaging, processing, use, sale, distribution, storage, import, export or disposal of any of the Company’s product candidates (collectively, the “Healthcare Health Care Laws”). Neither ; (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 nor is not in violation, in any material respect, of any term of any such Regulatory Authorizations; (iv) has fulfilled and performed all of its subsidiariesmaterial obligations with respect to the Regulatory Authorizations required to conduct its business as currently conducted and, nor to the Company’s knowledge, their officers, directors, employees, agents, have engaged in activities no event has occurred which are, as applicable, cause for false claims liability, civil penaltiesallows, or mandatory after notice or permissive exclusion from Medicarelapse of time would allow, Medicaid, revocation or termination thereof or results in any other state or federal healthcare program. Neither material impairment of the Company nor rights of the holder of any of its subsidiaries such Regulatory Authorization; (v) has not received written notice or other correspondence of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action (“ActionProceeding”) from any court, arbitrator governmental authority including any Regulatory Agency or Governmental Entity or any other third party alleging that any product, operation or activity is in a material violation of any Healthcare LawsHealth Care Laws or Regulatory Authorizations or limiting, andsuspending, 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”) required to conduct its business as currently conducted and that all such Reports were materially complete and correct on the date filed (or were materially corrected or supplemented by a subsequent submission); (vii) along with its employees, officers and directors, and to the Company’s knowledge, no such Action independent contractors and agents, is threatened. Neither the Company nor any of its subsidiaries is not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreementagreements, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan plans of correction or similar agreement agreements with or imposed by any Governmental Entity. Additionally, neither the Company nor governmental authority including any of Regulatory Agencies; and (viii) along with its subsidiaries, nor any of their employees, officers or and directors, or and to the Company’s knowledge, independent contractors and agents, is or has not been excluded, suspended or debarred from from, or otherwise rendered ineligible for participation in any U.S. state or federal healthcare government health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusionresearch.

Compliance with Healthcare Laws. The Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, the Company and its subsidiaries subsidiaries: (i) have been operated and currently operate their respective business in compliance in all material respects with all applicable healthcare provisions of the health care laws, rules and regulationsincluding Title XVIII of the Social Security Act, to the extent they apply to the Company and its current activities, including, without limitation, (i) the FDCA (21 42 U.S.C. §§ 301 et seq.1395-1395hhh (the Medicare statute); (ii) all applicable foreignTitle XIX of the Social Security Act, federal, state and local healthcare related fraud and abuse laws, including, without limitation, the federal Anti-kickback Statute (42 U.S.C. §§ 1320a-7b(b1396-1396v (the Medicaid statute); the Federal Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x), ; the civil False Claims Act (Act, 31 U.S.C. §§ 3729 et seq.), ; the criminal False Claims Law (Act 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 healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286§§286,287, 287and 1001, 1035, 1347 and 1349, the healthcare health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 1996, 42 U.S.C. §§ 1320d et seq., (“HIPAA”) (); the Civil Monetary Xxxxxxxxx Xxxx, 00 X.X.X. §§ 0000x-0x and 1320a-7b; the Physician Payments Xxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; the Exclusion Laws, 42 U.S.C. §§1320d et seq.), the Medicare statute (Title XVIII of the Social Security Act), and the Medicaid statute (Title XIX of the Social Security Act)§ 1320a-7; (iii) 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 (Act, 42 U.S.C. §§§ 17921 et seq.); (iv) comparable state the Federal Food, Drug, and local lawsCosmetic Act, 21 U.S.C. §§ 301 et seq.; and (v) the Public Health Service Act, 42 U.S.C. §§ 201 et seq.; each together with the regulations promulgated pursuant to such laws; and any similar federal, state and local laws and regulations of any governmental authority including the Regulatory Agencies applicable to the ownership, testing, development, manufacture, packaging, processing, pricing, use, distribution, storage, import, export or disposal of any of the Company’s product candidates or any product manufactured or distributed by the Company, (collectively, collectively the “Healthcare Health Care Laws”). Neither the Company nor ; (ii) have not received any of its subsidiariesFDA Form 483 that remains unresolved, nor to the Company’s knowledge, their officers, directors, employees, agents, have engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal healthcare program. Neither the Company nor any of its subsidiaries has received written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or Governmental Entity or regulatory authority alleging or asserting material non-compliance with (A) any Health Care Laws or (B) or any Governmental Licenses, approvals, clearances, exemptions, permits, registrations, authorizations, and supplements or amendments thereto required by any such Health Care Laws (“Regulatory Authorizations”); (iii) possess all material Regulatory Authorizations required to conduct their respective businesses as currently conducted and such Regulatory Authorizations are valid and in full force and effect and the Company and its subsidiaries are not in violation, in any material respect, of any term of any such Regulatory Authorizations; (iv) have not received notice of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action (“ActionProceeding”) from any court, arbitrator or Governmental Entity including any Regulatory Agency or any other third party alleging that any product, operation or activity is in a material violation of any Healthcare LawsHealth Care Laws or Regulatory Authorizations or limiting, suspending, modifying, or revoking any material Regulatory Authorizations, and have no knowledge that any Governmental Entity including any Regulatory Agencies or any other third party is considering any such Proceeding; (v) 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”) and that all such Reports were materially complete and correct on the date filed (or were materially corrected or supplemented by a subsequent submission); (vi) have not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any material recall, market withdrawal or replacement, safety alert, post-sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety, efficacy or regulatory compliance, or any alleged product defect or violation, of any marketed product, or initiated, conducted or issued any such notice or action with respect to a product during clinical development that has not been appropriately addressed in connection with such clinical development, and, to the Company’s knowledge, no third party, including the Company’s partners or collaborators, has initiated or conducted any such Action material notice or action, other than any such notice or action taken in connection with the termination of, clinical hold on or other changes to clinical studies or products, which termination, hold or other change is threatened. Neither described in the Registration Statement, the General Disclosure Package and the Prospectus and, to the Company’s knowledge, there are no facts which are reasonably likely to cause, and neither the Company nor any subsidiary, nor to the Company’s knowledge, its partners or collaborators, has received any written notice from the FDA or any other regulatory agency requesting, a recall, market withdrawal or replacement of any product sold or intended to be sold by the Company or its subsidiaries is or partners or collaborators, a change in the marketing classification or a material change in the labeling of any such products, or a termination or suspension of the manufacturing of any such products, except in each case for any such written notice that has been fully implemented and complied with; (vii) are not a party to or has have any ongoing reporting obligations pursuant to any corporate integrity agreementagreements, deferred prosecution agreementagreements, non-prosecution agreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan plans of correction or similar agreement agreements with or imposed by any Governmental Entity. Additionally, neither the Company nor Entity including any of its subsidiaries, nor any of Regulatory Agencies; and (viii) along with their respective employees, officers or and directors, or to the Company’s knowledge, agents, is or has have not been excluded, suspended or debarred from from, or otherwise ineligible for participation in any U.S. state or federal healthcare government health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusionresearch.

Compliance with Healthcare Laws. The Company and its subsidiaries have been in compliance in all material respects with all applicable healthcare laws, rules and regulations, to the extent they apply to the Company and its current activities, including, without limitation, subsidiaries: (i) have operated and currently operates their business in compliance with applicable health care laws, including Title XVIII of the FDCA (21 Social Security Act, 42 U.S.C. §§ 301 1395 et seq.. (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396 et seq (ii) all applicable foreign, federal, state and local healthcare related fraud and abuse laws, including, without limitation, the federal Medicaid statute); the Anti-kickback Statute (Kickback Statute, 42 U.S.C. § 1320a-7b(b)), ; the civil False Claims Act (Act, 31 U.S.C. §§ 3729 et seq.), ; the criminal False Claims Law (Act 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 healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1035, 1347 286 and 1349, 287 and the healthcare health care fraud criminal provisions under HIPAA; the U.S. Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a; the Physician Payments Sunshine Act, 42 U.S.C. § 1320a-7h; the exclusion law, 42 U.S.C. § 1320a-7; the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. §§1320d et seq.), the Medicare statute (Title XVIII of the Social Security Act), and the Medicaid statute (Title XIX of the Social Security Act); (iii) the patient privacy, data security and beach notification provisions under HIPAA1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (collectively, “HIPAA”), 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. §§17921 201 et seq.); (iv) comparable state and local laws42 U.S.C. § 263a et seq.; and (v) the regulations promulgated pursuant to such laws; and any similar national, state and local laws (collectivelyand regulations of any Governmental Entity including the Regulatory Authorities applicable to the ownership, the “Healthcare Laws”). Neither the Company nor testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any of its subsidiaries, nor to the Company’s knowledgeor its subsidiaries’ product candidates, their officersproducts or services, directors(collectively the “Health Care Laws”) except as would not, employeessingly or in the aggregate, agentsresult in a Material Adverse Effect; (ii) have not received any FDA Form 483, have engaged in activities which arewritten notice of adverse finding, as applicablewarning letter, cause for false claims liability, civil penalties, untitled letter or mandatory other written correspondence or permissive exclusion notice from Medicare, Medicaid, any court or arbitrator or governmental or regulatory authority alleging or asserting material non-compliance with (A) any Health Care Laws or (B) or any other state licenses, approvals, clearances, exemptions, permits, registrations, authorizations, and supplements or federal healthcare program. Neither amendments thereto required by any such Health Care Laws (“Regulatory Authorizations”); (iii) possess all material Regulatory Authorizations required to conduct their business as now conducted or as proposed in the SEC Filings to be conducted and such Regulatory Authorizations are valid and in full force and effect and neither the Company nor any of its subsidiaries has is in violation in any material respect of any term of any such Regulatory Authorizations; (iv) have not received written notice or other correspondence of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action (“ActionProceeding”) from any court, arbitrator or Governmental Entity including any Regulatory Authority or third any other third-party alleging that any product, operation or activity is in a material violation of any Healthcare LawsHealth Care Laws or Regulatory Authorizations or limiting, andsuspending, to modifying or revoking any material Regulatory Authorizations, and have no knowledge that any Governmental Entity including any Regulatory Authority or any other third-party is considering any Proceeding; (v) 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”) and all such Reports were materially complete and correct on the Company’s knowledge, no such Action is threatened. Neither the Company nor any of its subsidiaries is date filed (or were materially corrected or supplemented by a subsequent submission); (vi) are not a party to or has any have no ongoing reporting obligations pursuant to any corporate integrity agreementagreements, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan plans of correction or similar agreement agreements with or imposed by any Governmental Entity. Additionally, neither the Company nor Entity including any of its subsidiaries, nor any of Regulatory Authority; and (vii) along with their employees, officers or and directors, or to the Company’s knowledge, agents, is or has have not been excluded, suspended or debarred from from, or otherwise ineligible for participation in any U.S. state or federal healthcare government health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusionresearch.