Common use of Compliance with Regulatory Laws Clause in Contracts

Compliance with Regulatory Laws. Except as described in the Disclosure Materials, as applicable, the Company and the Subsidiary (i) are and at all times have been in compliance with all applicable statutes, rules and regulations in the United States or any other jurisdiction 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 candidate under development, manufactured or distributed by the Company, including, without limitation, the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), 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 administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the exclusion law (42 U.S.C. § 1320a-7), the statutes, regulations and directives of Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act) and all other government funded or sponsored healthcare programs including the TRICARE program (32 C.F.R. § 199.17), the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated pursuant to such laws, including, without limitation, the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any U.S. Department of Veterans Affairs agreement, and any successor government programs, and comparable state laws, regulations relating to Good Clinical Practices and Good Laboratory Practices and all other local, state, federal, national, supranational and foreign health care laws, manual provisions, policies and administrative guidance, in each case relating to the regulation of the Company or the Subsidiary (collectively, the “Applicable Laws”), except for such non-compliance as would not, individually or in the aggregate, have a Material Adverse Effect; (ii) have not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting non-compliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), except for such non-compliance as would not, individually or in the aggregate, have a Material Adverse Effect; (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are not in violation of any term of any such Authorizations, except for such violations as would not, individually or in the aggregate, have a Material Adverse Effect; (iv) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (v) have not received written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take action to materially limit, suspend, materially modify or revoke any Authorizations nor, to the Company’s knowledge, is any such limitation, suspension, modification or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority.

Compliance with Regulatory Laws. Except as described in the Disclosure MaterialsRegistration Statement and the Prospectus, as applicable, the Company and the Subsidiary (i) are and at all times have been in compliance with all applicable statutes, rules and regulations in the United States or any other jurisdiction 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 candidate under development, manufactured or distributed by the Company, including, without limitation, the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), 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 administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the exclusion law (42 U.S.C. § 1320a-7), the statutes, regulations and directives of Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act) and all other government funded or sponsored healthcare programs including the TRICARE program (32 C.F.R. § 199.17), the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated pursuant to such laws, including, without limitation, the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any U.S. Department of Veterans Affairs agreement, and any successor government programs, and comparable state laws, regulations relating to Good Clinical Practices and Good Laboratory Practices and all other local, state, federal, national, supranational and foreign health care laws, manual provisions, policies and administrative guidance, in each case relating to the regulation of the Company or the Subsidiary (collectively, the “Applicable Laws”), except for such non-compliance as would not, individually or in the aggregate, have a Material Adverse Effect; (ii) have not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting non-compliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), except for such non-compliance as would not, individually or in the aggregate, have a Material Adverse Effect; (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are not in violation of any term of any such Authorizations, except for such violations as would not, individually or in the aggregate, have a Material Adverse Effect; (iv) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (v) have not received written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take action to materially limit, suspend, materially modify or revoke any Authorizations nor, to the Company’s knowledge, is any such limitation, suspension, modification or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority.

Compliance with Regulatory Laws. Except as described in the Registration Statement, the General Disclosure Materials, as applicablePackage and the Prospectus, the Company and the Subsidiary its subsidiaries: (iA) are and at all times have been in material compliance with all applicable statutes, rules and or regulations in of the United States or any other jurisdiction Regulatory Authorities 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 candidate under development, manufactured or distributed by the CompanyCompany or its subsidiaries (“Applicable Laws”), including, without limitation, the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), the federal Plant Protection Act (7 U.S.C. § 7701 et seq.), the U.S. Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the civil U.S. Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the administrative criminal False Claims Law (42 U.S.C. § 1320a-7b(a1320a- 7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the Anti-Inducement Law health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. § 1320a-7a(a)(5)Section 1320d et seq.), the exclusion law laws (42 U.S.C. § 1320a-7), the statutes, regulations and directives of Medicare civil monetary penalties law (Title XVIII of the Social Security Act42 U.S.C. § 1320a-7a), Medicaid (Title XIX of the Social Security Act) and all other government funded or sponsored healthcare programs including the TRICARE program (32 C.F.R. § 199.17), the Health Insurance Portability and Accountability Act of 1996HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009(42 U.S.C. Section 17921 et seq.), and the Patient Protection regulations promulgated pursuant to such statutes; the Medicare statute (Title XVIII of the Social Security Act); the Medicaid statute (Title XIX of the Social Security Act); and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated pursuant to such laws, including, without limitation, the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any U.S. Department of Veterans Affairs agreement, and any successor government programs, and comparable state laws, regulations relating to Good Clinical Practices and Good Laboratory Practices and all other local, state, federal, national, supranational and foreign health care laws, manual provisions, policies and administrative guidance, in each case laws relating to the regulation of the Company or the Subsidiary (collectively, the “Applicable Laws”), except for such non-compliance as would not, individually or in the aggregate, have a Material Adverse EffectCompany; (iiB) have has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any Regulatory Authority or court or arbitrator or governmental or regulatory authority or third party of competent jurisdiction alleging or asserting non-compliance material noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), except for such non-compliance as would not, individually or in the aggregate, have a Material Adverse EffectGovernmental Licenses; (iiiC) possess possesses all material Authorizations Governmental Licenses and such Authorizations Governmental Licenses are valid and in full force and effect and are the Company is not in material violation of any term of any such Authorizations, except for such violations as would not, individually or in the aggregate, have a Material Adverse EffectGovernmental Licenses; (ivD) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority Regulatory Authority or third party alleging that any product operation or development activity is in material violation of any Applicable Laws or Authorizations nor, to the Company’s knowledge, Governmental Licenses and has no knowledge that any Regulatory Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (vE) have has not received written notice that any court or arbitrator or governmental or regulatory authority Regulatory Authority has taken, is taking or intends to take action to materially limit, suspend, materially modify suspend or revoke any Authorizations nor, to the Company’s knowledge, material Governmental Licenses and has no knowledge that any Regulatory Authority is any considering such limitation, suspension, modification or revocation threatenedaction; and (viF) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations Governmental Licenses and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and accurate correct on the date filed in all material respects (or were corrected or supplemented by a subsequent submission); and (vii) are not . Neither the Company nor 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 Entity. Additionally, neither the Company, its subsidiaries nor to the knowledge of the Company, any of their respective employees, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or regulatory authorityother similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Regulatory Laws. Except as described in the Registration Statement, the General Disclosure Materials, as applicablePackage and the Prospectus, the Company and the Subsidiary its subsidiaries: (iA) are and at all times have been in material compliance with all applicable statutes, rules and or regulations in of the United States or any other jurisdiction Regulatory Authorities 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 candidate under development, manufactured or distributed by the CompanyCompany or its subsidiaries (“Applicable Laws”), including, without limitation, the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.)Act, the federal U.S. Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the civil U.S. Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the administrative criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the Anti-Inducement Law health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. § 1320a-7a(a)(5)Section 1320d et seq.), the exclusion law laws (42 U.S.C. § 1320a-7), the statutes, regulations and directives of Medicare civil monetary penalties law (Title XVIII of the Social Security Act42 U.S.C. § 1320a-7a), Medicaid (Title XIX of the Social Security Act) and all other government funded or sponsored healthcare programs including the TRICARE program (32 C.F.R. § 199.17), the Health Insurance Portability and Accountability Act of 1996HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009(42 U.S.C. Section 17921 et seq.), and the Patient Protection regulations promulgated pursuant to such statutes; the Medicare statute (Title XVIII of the Social Security Act); the Medicaid statute (Title XIX of the Social Security Act); and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated pursuant to such laws, including, without limitation, the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any U.S. Department of Veterans Affairs agreement, and any successor government programs, and comparable state laws, regulations relating to Good Clinical Practices and Good Laboratory Practices and all other local, state, federal, national, supranational and foreign health care laws, manual provisions, policies and administrative guidance, in each case laws relating to the regulation of the Company or the Subsidiary (collectively, the “Applicable Laws”), except for such non-compliance as would not, individually or in the aggregate, have a Material Adverse EffectCompany; (iiB) have has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any Regulatory Authority or court or arbitrator or governmental or regulatory authority or third party of competent jurisdiction alleging or asserting non-compliance material noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), except for such non-compliance as would not, individually or in the aggregate, have a Material Adverse EffectGovernmental Licenses; (iiiC) possess possesses all material Authorizations Governmental Licenses and such Authorizations Governmental Licenses are valid and in full force and effect and are the Company is not in material violation of any term of any such Authorizations, except for such violations as would not, individually or in the aggregate, have a Material Adverse EffectGovernmental Licenses; (ivD) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority Regulatory Authority or third party alleging that any product operation or development activity is in material violation of any Applicable Laws or Authorizations nor, to the Company’s knowledge, Governmental Licenses and has no knowledge that any Regulatory Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (vE) have has not received written notice that any court or arbitrator or governmental or regulatory authority Regulatory Authority has taken, is taking or intends to take action to materially limit, suspend, materially modify suspend or revoke any Authorizations nor, to the Company’s knowledge, material Governmental Licenses and has no knowledge that any Regulatory Authority is any considering such limitation, suspension, modification or revocation threatenedaction; and (viF) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations Governmental Licenses and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and accurate correct on the date filed in all material respects (or were corrected or supplemented by a subsequent submission); and (vii) are not . Neither the Company nor 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 Entity. Additionally, neither the Company, its subsidiaries nor to the knowledge of the Company, any of their respective employees, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or regulatory authorityother similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Regulatory Laws. Except as described in the Disclosure Materials, as applicableRegistration Statement, the Company General Disclosure Package, the Prospectus and the Subsidiary European Prospectus, the Company: (iA) are is and at all times have has been in compliance with all applicable statutes, rules and or regulations in of the United States or any other jurisdiction Regulatory Authorities 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 candidate under development, manufactured or distributed by the CompanyCompany (“Applicable Laws”), including, without limitation, the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.)Act, the federal U.S. Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the civil U.S. Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the administrative criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the Anti-Inducement Law health care fraud criminal provisions, including 18 U.S.C. § 1347, under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. § 1320a-7a(a)(5)Section 1320d et seq.), the exclusion law laws (42 U.S.C. § 1320a-7), the statutes, regulations and directives of Medicare civil monetary penalties law (Title XVIII of the Social Security Act42 U.S.C. § 1320a-7a), Medicaid (Title XIX of the Social Security Act) and all other government funded or sponsored healthcare programs including the TRICARE program (32 C.F.R. § 199.17), the Health Insurance Portability and Accountability Act of 1996HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the Medicare statute (Title XVIII of 2009, and the Patient Protection and Affordable Care Act Social Security Act); the Medicaid statute (Title XIX of 2010, as amended by the Health Care and Education Reconciliation Act of 2010Social Security Act), the regulations promulgated pursuant to such laws, including, without limitation, the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any U.S. Department of Veterans Affairs agreement, and any successor government programs, and comparable state laws, regulations relating to Good Clinical Practices and Good Laboratory Practices laws and all other similar local, state, federal, national, supranational and foreign health care laws, manual provisions, policies and administrative guidance, in each case laws relating to the regulation of the Company or the Subsidiary (collectively, the “Applicable Laws”)Company, except for such non-compliance as where the failure so to comply would not, individually singly or in the aggregate, have reasonably be expected to result in a Material Adverse Effect; (iiB) have has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any Regulatory Authority or court or arbitrator or governmental or regulatory authority or third party of competent jurisdiction alleging or asserting non-compliance material noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations Laws. The Company is not party to and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), except for such non-compliance as would not, individually or in the aggregate, have a Material Adverse Effect; (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are not in violation of any term of any such Authorizations, except for such violations as would not, individually or in the aggregate, have a Material Adverse Effect; (iv) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (v) have not received written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take action to materially limit, suspend, materially modify or revoke any Authorizations nor, to the Company’s knowledge, is any such limitation, suspension, modification or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission); and (vii) are not a party no ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entity. Additionally, neither the Company, nor, to the knowledge of the Company, any of its employees, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or regulatory authorityother similar action that would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Regulatory Laws. Except as described in the Disclosure Materials, as applicableRegistration Statement and the Prospectus, the Company and the Subsidiary its subsidiaries: (iA) are and at all times have been in material compliance with all applicable statutes, rules and or regulations in of the United States or any other jurisdiction Regulatory Authorities 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 candidate under development, manufactured or distributed by the CompanyCompany or its subsidiaries (“Applicable Laws”), including, without limitation, the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), the federal Plant Protection Act (7 U.S.C. § 7701 et seq.), the U.S. Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the civil U.S. Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the administrative criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the Anti-Inducement Law health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. § 1320a-7a(a)(5)Section 1320d et seq.), the exclusion law laws (42 U.S.C. § 1320a-7), the statutes, regulations and directives of Medicare civil monetary penalties law (Title XVIII of the Social Security Act42 U.S.C. § 1320a-7a), Medicaid (Title XIX of the Social Security Act) and all other government funded or sponsored healthcare programs including the TRICARE program (32 C.F.R. § 199.17), the Health Insurance Portability and Accountability Act of 1996HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009(42 U.S.C. Section 17921 et seq.), and the Patient Protection regulations promulgated pursuant to such statutes; the Medicare statute (Title XVIII of the Social Security Act); the Medicaid statute (Title XIX of the Social Security Act); and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated pursuant to such laws, including, without limitation, the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any U.S. Department of Veterans Affairs agreement, and any successor government programs, and comparable state laws, regulations relating to Good Clinical Practices and Good Laboratory Practices and all other local, state, federal, national, supranational and foreign health care laws, manual provisions, policies and administrative guidance, in each case laws relating to the regulation of the Company or the Subsidiary (collectively, the “Applicable Laws”), except for such non-compliance as would not, individually or in the aggregate, have a Material Adverse EffectCompany; (iiB) have has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any Regulatory Authority or court or arbitrator or governmental or regulatory authority or third party of competent jurisdiction alleging or asserting non-compliance material noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), except for such non-compliance as would not, individually or in the aggregate, have a Material Adverse EffectGovernmental Licenses; (iiiC) possess possesses all material Authorizations Governmental Licenses and such Authorizations Governmental Licenses are valid and in full force and effect and are the Company is not in material violation of any term of any such Authorizations, except for such violations as would not, individually or in the aggregate, have a Material Adverse EffectGovernmental Licenses; (ivD) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority Regulatory Authority or third party alleging that any product operation or development activity is in material violation of any Applicable Laws or Authorizations nor, to the Company’s knowledge, Governmental Licenses and has no knowledge that any Regulatory Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (vE) have has not received written notice that any court or arbitrator or governmental or regulatory authority Regulatory Authority has taken, is taking or intends to take action to materially limit, suspend, materially modify suspend or revoke any Authorizations nor, to the Company’s knowledge, material Governmental Licenses and has no knowledge that any Regulatory Authority is any considering such limitation, suspension, modification or revocation threatenedaction; and (viF) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations Governmental Licenses and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and accurate correct on the date filed in all material respects (or were corrected or supplemented by a subsequent submission); and (vii) are not . Neither the Company nor 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 Entity. Additionally, neither the Company, its subsidiaries nor to the knowledge of the Company, any of their respective employees, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or regulatory authorityother similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Regulatory Laws. Except as described in the Registration Statement, the General Disclosure Materials, as applicablePackage and the Prospectus, the Company and the Subsidiary its subsidiaries: (iA) are and at all times have been in material compliance with all applicable statutes, rules and or regulations in of the United States or any other jurisdiction Regulatory Authorities 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 candidate under development, manufactured or distributed by the CompanyCompany or its subsidiaries (“Applicable Laws”), including, without limitation, the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), the federal Plant Protection Act (7 U.S.C. § 7701 et seq.), the U.S. Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the civil U.S. Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the administrative criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the Anti-Inducement Law health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. § 1320a-7a(a)(5)Section 1320d et seq.), the exclusion law laws (42 U.S.C. § 1320a-7), the statutes, regulations and directives of Medicare civil monetary penalties law (Title XVIII of the Social Security Act42 U.S.C. § 1320a-7a), Medicaid (Title XIX of the Social Security Act) and all other government funded or sponsored healthcare programs including the TRICARE program (32 C.F.R. § 199.17), the Health Insurance Portability and Accountability Act of 1996HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009(42 U.S.C. Section 17921 et seq.), and the Patient Protection regulations promulgated pursuant to such statutes; the Medicare statute (Title XVIII of the Social Security Act); the Medicaid statute (Title XIX of the Social Security Act); and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated pursuant to such laws, including, without limitation, the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any U.S. Department of Veterans Affairs agreement, and any successor government programs, and comparable state laws, regulations relating to Good Clinical Practices and Good Laboratory Practices and all other local, state, federal, national, supranational and foreign health care laws, manual provisions, policies and administrative guidance, in each case laws relating to the regulation of the Company or the Subsidiary (collectively, the “Applicable Laws”), except for such non-compliance as would not, individually or in the aggregate, have a Material Adverse EffectCompany; (iiB) have has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any Regulatory Authority or court or arbitrator or governmental or regulatory authority or third party of competent jurisdiction alleging or asserting non-compliance material noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), except for such non-compliance as would not, individually or in the aggregate, have a Material Adverse EffectGovernmental Licenses; (iiiC) possess possesses all material Authorizations Governmental Licenses and such Authorizations Governmental Licenses are valid and in full force and effect and are the Company is not in material violation of any term of any such Authorizations, except for such violations as would not, individually or in the aggregate, have a Material Adverse EffectGovernmental Licenses; (ivD) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority Regulatory Authority or third party alleging that any product operation or development activity is in material violation of any Applicable Laws or Authorizations nor, to the Company’s knowledge, Governmental Licenses and has no knowledge that any Regulatory Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (vE) have has not received written notice that any court or arbitrator or governmental or regulatory authority Regulatory Authority has taken, is taking or intends to take action to materially limit, suspend, materially modify suspend or revoke any Authorizations nor, to the Company’s knowledge, material Governmental Licenses and has no knowledge that any Regulatory Authority is any considering such limitation, suspension, modification or revocation threatenedaction; and (viF) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations Governmental Licenses and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and accurate correct on the date filed in all material respects (or were corrected or supplemented by a subsequent submission); and (vii) are not . Neither the Company nor 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 Entity. Additionally, neither the Company, its subsidiaries nor to the knowledge of the Company, any of their respective employees, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or regulatory authorityother similar action that could reasonably be expected to result in debarment, suspension, or exclusion.