Common use of Compliance with Health Care Laws Clause in Contracts

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times have been, in material compliance with all Health Care Laws applicable to biopharmaceutical products. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor any of their respective employees, officers, directors, or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Neither the Company and its subsidiaries areor any subsidiary, and at all times have been, nor the Company’s or any subsidiary’s business operations is in material compliance with all violation of any Health Care Laws applicable Laws, except where such violation would not reasonably be expected to biopharmaceutical productsresult in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: means (i) the Federal Food, Drug, Food Drug and Cosmetic Act (21 U.S.C. Section §§ 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local federal and foreign health care state fraud and abuse lawslaws referred to generally or specifically in the Preliminary Prospectus and the Prospectus, including, without limitationbut not limited to, the federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b§ 1320a-7(b)), the Civil civil False Claims Act (31 U.S.C. Section § 3729 et seq.), the criminal false statements law administrative False Claims Law (42 U.S.C. Section § 1320a-7b(a)), 18 U.S.C. Sections 286 1320a-7 and 287, 1320a-7a of Title 42 of the health care fraud criminal provisions under United States Code and the U.S. regulations promulgated pursuant to such statutes; (iii) the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.Pub. L. No. 104-191), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health, and the regulations promulgated thereunder, (iv) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (v) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (vi) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. Section 17921 et seq.§ 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; (ivvii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other localapplicable federal, state, federalor foreign health care laws or regulations, national, supranational and foreign laws, relating including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the regulation of contrary, the Company makes no representations or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to warranties regarding compliance by the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements physician customers with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor any of their respective employees, officers, directors, or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusionapplicable laws.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times have been, in material compliance with all Health Care Laws applicable to biopharmaceutical products. For purposes of this Agreement, “Health Care Laws” meansmeans all health care laws applicable to the Company, including, but not limited to: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section §§ 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law False Claims Law (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law exclusion laws (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section § 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); , Medicare (iv) Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and any and all other similar state, local, state, federal, national, supranational federal or foreign health care laws and foreign laws, relating to the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820 and all other laws and regulations applicable to ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of the Company’s products, each as amended from time to time. Except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, the Company (i) is and at all times has been in compliance with all Health Care Laws and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or non-U.S. counterpart thereoffederal health care program; and (ii) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting noncompliance with (x) any Health Care Laws or (y) any Governmental Licenses required by any such Health Care Laws. Neither Except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, the Company nor has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any of its subsidiaries Health Care Laws or Governmental Licenses and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were materially corrected or supplemented by a subsequent submission). Except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in a violation of any Health Care Laws norLaws, and, to the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is not a party to and has no ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authorityGovernmental Entity. Additionally, neither the Company nor any of its subsidiaries nor any of their respective employees, officers, directors, or agents or, to the knowledge of the Company, agents, has been excluded, suspended or debarred from participation in any U.S. federal health care program or human research study or clinical research trial or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times have been, in material compliance with all Health Care Laws applicable to biopharmaceutical products. For purposes of this Agreement, “Health Care Laws” meansmeans all health care laws applicable to the Company, including, but not limited to: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitationAct, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law False Claims Law (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law exclusion laws (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section § 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); , Medicare (iv) Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and any and all other similar state, local, state, federal, national, supranational federal or foreign health care laws and foreign laws, relating to the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820 and any state all other laws and regulations applicable to ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or non-U.S. counterpart thereofdisposal of the Company’s products, each as amended from time to time. Neither the The Company nor any of its subsidiaries has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in a material violation of any Health Care Laws norLaws, and, to the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is not a party to and has no ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor nor, to the knowledge of the Company, any of its subsidiaries nor any of their respective employees, officers, directors, officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human research study or clinical research trial or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times have been, in material compliance with all applicable Health Care Laws applicable to biopharmaceutical products(as defined below), and have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid or any other state, federal or national health care program, except where such noncompliance, false claims liability or civil penalties would not reasonably be expected to, singly or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” meansmeans all health care laws applicable to the Company, including, but not limited to: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law False Claims Law (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law exclusion laws (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section § 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); , Medicare (iv) Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), any and all other applicable comparable local, state, federal, national, supranational and foreign laws, relating to health care laws and the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereoflaws, each as amended from time to time. Neither the Company nor any of its subsidiaries has have 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 material violation of any Health Care Laws norLaws, and, to the Company’s knowledgeknowledge of the Company and each of its subsidiaries, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is have received any written notice of adverse filing, warning letter, untitled letter or other correspondence or notice from the FDA, the European Commission, the EMA or any other Health Regulatory Agencies, or any other court or arbitrator, alleging or asserting material noncompliance with the Health Care Laws. Neither the Company nor any of its subsidiaries are a party to and has no ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor nor, to the knowledge of the Company, any of their respective its employees, officers, directors, officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research study or trial or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Neither the Company and its subsidiaries areor any subsidiary, and at all times have been, nor the Company’s or any subsidiary’s business operations is in material compliance with all violation of any Health Care Laws applicable Laws, except where such violation would not reasonably be expected to biopharmaceutical productsresult in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: means (i) the Federal Food, Drug, federal and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care state fraud and abuse lawslaws referred to generally or specifically in the Preliminary Prospectus and the Prospectus, including, without limitationbut not limited to, the federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b§ 1320a-7(b)), the Civil Xxxxx Law (42 U.S.C. § 1395nn), the civil False Claims Act (31 U.S.C. Section § 3729 et seq.), the criminal false statements law administrative False Claims Law (42 U.S.C. Section § 1320a-7b(a)), 18 U.S.C. Sections 286 1320a-7 and 287, 1320a-7a of Title 42 of the health care fraud criminal provisions under United States Code and the U.S. regulations promulgated pursuant to such statutes; (ii) the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”Pub. L. No. 104-191) (42 U.S.C. Section 1320d et seq.)and the regulations promulgated thereunder, the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by Medicare (Title XVIII of the Health Information Technology for Economic Social Security Act) and Clinical Health Act (42 U.S.C. Section 17921 et seq.)the regulations promulgated thereunder; (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation Medicaid (Title XIX of the Company or its subsidiariesSocial Security Act) and the regulations promulgated thereunder; and (v) the directives Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. No. 108-173) and the regulations promulgated pursuant thereunder; (vi) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (vii) any and all other applicable federal, state, or foreign health care laws or regulations, each of (i) through (vii) as may be amended from time to such statutes and any state time. Notwithstanding the foregoing or non-U.S. counterpart thereof. Neither anything herein to the contrary, the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration makes no representations or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to warranties regarding compliance by the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements physician customers with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor any of their respective employees, officers, directors, or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusionapplicable laws.

Compliance with Health Care Laws. The Company is and its subsidiaries are, and at all times have been, has been in material compliance with all Health Care Laws applicable (as hereinafter defined), except where instances of non-compliance would not, singly or in the aggregate, reasonably be expected to biopharmaceutical productsresult in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” meansmeans all health care laws applicable to the Company, including, but not limited to: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitationAct, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law False Claims Law (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law exclusion laws (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section § 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); , Medicare (iv) Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and any and all other local, similar state, federal, national, supranational local or federal health care laws and foreign laws, relating to the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820, and all other laws and regulations applicable to ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of the Company’s products, each as amended from time to time. The Company has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or non-U.S. counterpart thereoffederal health care program, except where such noncompliance, false claims liability or civil penalties would not reasonably be expected to, singly or in the aggregate, result in a Material Adverse Effect. Neither the The Company nor any of its subsidiaries has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in a material violation of any Health Care Laws norLaws, and, to the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is not a party to and has no ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor nor, to the knowledge of the Company, any of its subsidiaries nor any of their respective employees, officers, directors, officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal health care program program, clinical trial or human clinical research registry or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion. Except as described in the Registration Statement, the Preliminary Prospectus and the Prospectus or as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting noncompliance with (x) any Health Care Laws or (y) any Governmental Licenses required by any such Health Care Laws.

Compliance with Health Care Laws. The Except as would not reasonably be expected to have a Material Adverse Effect, the Company and each of its subsidiaries are, and at all times have been, is conducting its business in material compliance with all Health Care Laws applicable to biopharmaceutical products. For purposes health care laws, rules, and regulations of this Agreementeach jurisdiction in which it conducts its business (collectively, the “Health Care Laws” means: ”), including, without limitation, (iA) the Federal Food, Drug, Drug and Cosmetic Act (21 U.S.C. Section §§ 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the rules and regulations promulgated thereunder pertaining to biopharmaceutical products; (iias amended, collectively, the “FFDCA”), (B) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local federal and foreign health care state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b§ 1320a-7(b)), the Civil Xxxxx Law (42 U.S.C. §1395nn), the civil False Claims Act (31 U.S.C. Section § 3729 et seq.), the criminal false statements law administrative False Claims Law (42 U.S.C. Section § 1320a-7b(a)), 18 U.S.C. Sections 286 1320a-7 and 2871320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes, (C) the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (18 U.S.C. §§669, 1035, 1347 and 1518; 42 U.S.C. Section §1320d et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and the regulations promulgated thereunder, (D) the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (42 U.S.C. Section 17921 §1395w-101 et seq.); ) and the regulations promulgated thereunder, (ivE) all other localthe Patient Protection and Affordable Care Act, stateas amended by the Health Care and Education Affordability Reconciliation Act of 2010, federal(F) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder, nationaland (G) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder, supranational and foreign each of such applicable laws, relating to the regulation of the Company or its subsidiaries; and (v) the directives rules and regulations promulgated pursuant as may be amended from time to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor any of their respective employees, officers, directors, or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusiontime.

Compliance with Health Care Laws. The Company and, to the Company’s knowledge, its directors, employees and its subsidiaries are, agents (while acting in such capacity) are and at all times have been, been in material compliance with with, all Health Care Laws health care laws applicable to biopharmaceutical products. For purposes the Company, or any of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse lawsits products or activities, including, without limitationbut not limited to, the federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), the civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law administrative False Claims Law (42 U.S.C. Section 1320a-7b(a)), 18 the Xxxxx law (42 U.S.C. Sections 286 and 287Section 1395nn), the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); , the exclusion laws (iv) all other local42 U.S.C. Section 1320a-7), statethe Federal Food, federalDrug, nationaland Cosmetic Act (21 U.S.C. Section 301 et seq.), supranational and foreign lawsthe Controlled Substances Act (21 U.S.C. Section 801 et seq.), relating to the regulation Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Company or its subsidiaries; Social Security Act), Medicaid (Title XIX of the Social Security Act), and (v) the directives 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 statutes laws, and any state other state, federal or non-U.S. counterpart thereofforeign law, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes legally binding requirements on manufacturing, development, testing, labeling, advertising, marketing, promotion, distribution, reporting, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care programs, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, “Health Care Laws”). Neither the The Company nor has not received any of its subsidiaries has received notification, correspondence or any other written notice or oral communication, including notification of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court governmental authority, including, without limitation, the FDA, the EMA, Health Canada, the U.S. Federal Trade Commission, the U.S. Drug Enforcement Administration (“DEA”), CMS, HHS’s Office of Inspector General, the U.S. Department of Justice and state Attorneys General or arbitrator similar agencies of potential or governmental actual non-compliance by, or regulatory authority or third party alleging that any product operation or activity is in violation of liability of, the Company under any Health Care Laws norLaws, except, with respect to any of the foregoing, such as would not, individually or in the aggregate, result in a Material Adverse Effect. To the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration there are no facts or other action threatened. The circumstances that would reasonably be expected to give rise to material liability of the Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by under any Health Care Laws, . The statements with respect to Health Care Laws and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor any of their respective employees, officers, directors, or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result ’s compliance therewith included in debarment, suspension, or exclusionthe Registration Statement and in the Prospectus fairly summarize the matters therein described.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times have been, in compliance in all material compliance respects with all applicable Health Care Laws applicable to biopharmaceutical productsLaws. For purposes of this Agreement, “Health Care Laws” in all material respects means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical productsthereunder; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable U.S. federal, state, local and foreign non-U.S. health care fraud and abuse laws, including, without limitation, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable U.S. federal, state, local or non-U.S. laws or regulatory bodies; (vi) all other local, state, U.S. federal, national, supranational and foreign laws, non-U.S. laws relating to the regulation of the Company or and its subsidiaries; , and (vvii) the directives and regulations promulgated pursuant to such statutes statutes, and any state or non-U.S. counterpart thereof. Neither the Company nor any of its subsidiaries has received written any Form FDA 483, notice of adverse finding, warning letter, untitled letter or other adverse correspondence or notice from Regulatory Authorities, or notice of any deficiency, noncompliance, pending or threatened 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 activity is or potentially is in violation of any Health Care Laws nor, to the Company’s knowledgeknowledge of the Company and its subsidiaries, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedthreatened or pending. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor any of their respective employees, officers, directors, or their respective agents has been excluded, suspended suspended, debarred or debarred disqualified from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, disqualification, suspension, or exclusion, has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in debarment under 21 U.S.C. Section 335a or comparable foreign law or has been liable for a civil monetary penalty under 21 U.S.C. Section 335b or comparable foreign law.

Compliance with Health Care Laws. The Company has operated and its subsidiaries are, and at all times have been, currently is in material compliance with all Health Care Laws applicable health care laws, rules and regulations (except where such failure to biopharmaceutical products. For purposes of this Agreementoperate or non-compliance would not, “Health Care Laws” means: individually or in the aggregate, result in a Material Adverse Effect), including, without limitation, (i) the Federal Federal, Food, Drug, Drug and Cosmetic Act (21 U.S.C. Section §§ 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and all applicable foreign health care healthcare related fraud and abuse laws, including, without limitation, the federal Anti-Kickback kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the Civil U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal false statements law False Claims Law (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to healthcare fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, the health care healthcare fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), and the civil monetary penalties law (42 U.S.C. Section § 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) all applicable federal, state, local and all applicable foreign laws and regulations pertaining to the testing and manufacture of healthcare products including, without limitation, Basic Health and Human Services Policy for Protection of Human Research Subjects “Common Rule” as codified and enforced by the Department of Health and Human Services in 45 C.F.R. part 46 and enforced by FDA under 21 C.F.R. part 50, Good Clinical Practices (as defined below) and Good Laboratory Practices, Laboratory Animal Welfare Act of 1966, the Controlled Substances Act (2 U.S.C. § 801, et seq.) and Good Manufacturing Practices (21 C.F.R. §§210 & 211); (v) the regulations promulgated pursuant to such laws; and (vi) any other similar local, state, federal, nationalor foreign laws (collectively, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof“Health Care Laws”). Neither the Company Company, nor to the Company’s knowledge, any of its subsidiaries officers, directors, employees or agents have engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal healthcare program. The Company has not received written notice or other correspondence of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action (“Action”) from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws norLaws, and, to the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is not a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreementsagreement, deferred prosecution agreement, monitoring agreementsagreement, consent decreesdecree, settlement ordersorder, plan of correction or similar agreements with or agreement imposed by any governmental or regulatory authority. Additionally, neither the Company Company, nor to the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers, officers or directors, or agents has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times have been, in material compliance with all applicable Health Care Laws applicable to biopharmaceutical productsLaws. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical productsthereunder; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof, in each case excluding Privacy Laws. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor Company, any of its subsidiaries nor any of their respective employees, officers, directors, or or, to the knowledge of the Company, agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times have been, in material compliance with all Health Care Laws applicable to biopharmaceutical products. For purposes of this Agreement, “Health Care Laws” means: (i) means all health care laws applicable to the Company, including, but not limited to, the following laws to the extent applicable, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitationAct, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law False Claims Law (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law exclusion laws (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section § 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.) and similar state and foreign privacy and data security laws such as the European Union General Data Protection Regulation, Medicare (Title XVIII of the Social Security Act); , Medicaid (iv) Title XIX of the Social Security Act), and any and all other similar state, local, state, federal, national, supranational federal or foreign health care laws and foreign laws, relating to the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820 and any state all other laws and regulations applicable to ownership, testing, development, sale, marketing, manufacture, packaging, processing, use, distribution, storage, import, export or non-U.S. counterpart thereofdisposal of the Company’s products, each as amended from time to time. Neither the The Company nor any of its subsidiaries has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in a material violation of any Health Care Laws norLaws, and, to the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is not a party to and has no ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor nor, to the knowledge of the Company, any of its subsidiaries nor any of their respective employees, officers, directors, officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human research study or clinical research trial or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, proceeding or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times during the last three years have been, in material compliance compliance, and have taken any required and necessary actions to comply, with all Health Care Laws applicable Laws, except where noncompliance would not singly or in the aggregate reasonably be expected to biopharmaceutical productsresult in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” meansmeans all health care laws applicable to the Company or any of its subsidiaries, including, but not limited to: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.)Act, the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the U.S. Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law False Claims Act (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law exclusion laws (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section § 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); , Medicare (iv) Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and any and all other similar state, local, state, federal, national, supranational federal or foreign (including Israeli) health care laws and foreign laws, relating to the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820 and all other laws and regulations applicable to ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of the Company’s or any state or non-U.S. counterpart thereofof its subsidiaries’ products, each as amended from time to time. Neither the Company nor any of its subsidiaries has received any Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA, or written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in a material violation of any Health Care Laws norLaws, and, to the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to or has ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither none the Company nor or any of its subsidiaries nor subsidiaries, or, to the knowledge of the Company, any of their respective its or its subsidiaries’ employees, officers, directors, officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human research study or clinical research trial or, to the knowledge of the Company, is subject to a governmental an inquiry, investigation, proceeding, or other similar action by any governmental authority that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times have been, in material compliance with all Health Care Laws applicable to biopharmaceutical products. For purposes of this Agreement, “Health Care Laws” means: (i) means all health care laws applicable to the Company and/or its subsidiary, including, but not limited to, the following laws to the extent applicable, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitationAct, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law False Claims Law (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law exclusion laws (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section § 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.) and similar state and foreign privacy and data security laws such as the European Union General Data Protection Regulation, Medicare (Title XVIII of the Social Security Act); , Medicaid (iv) Title XIX of the Social Security Act), and any and all other similar state, local, state, federal, national, supranational federal or foreign health care laws and foreign laws, relating to the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820 and any state all other laws and regulations applicable to ownership, testing, development, sale, marketing, manufacture, packaging, processing, use, distribution, storage, import, export or non-U.S. counterpart thereofdisposal of the Company’s products, each as amended from time to time. Neither the Company nor any of its subsidiaries subsidiary has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in a material violation of any Health Care Laws norLaws, and, to the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries subsidiary is a party to or has ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither none of the Company nor any Company, its subsidiary or, to the knowledge of its subsidiaries nor the Company, any of their respective employees, officers, directors, officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human research study or clinical research trial or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, proceeding or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times for the past six (6) years have been, in material compliance with all applicable Health Care Laws applicable to biopharmaceutical productsLaws. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical productsthereunder; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law False Statements Law (42 U.S.C. Section 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 286, 287, 1035, 1347, and 1349 the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion exclusions law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C Section 1320-7h), and applicable the laws governing U.S. government funded or sponsored healthcare programs; and (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries; and (v) the directives rules and regulations promulgated pursuant to such statutes laws and any applicable state or non-U.S. counterpart thereof. Neither Over the past six (6) years, neither the Company nor any of its subsidiaries subsidiaries, nor any of their respective officers, directors, employees or agents have engaged in activities which are, as applicable, cause for material liability under any applicable Health Care Law. Over the past six (6) years, the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is has any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action been threatened. The Over the past six (6) years, the Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityauthority or body. Additionally, for the past six (6) years, neither the Company nor Company, any of its subsidiaries nor any of their respective employees, officers, directors, or agents agents, has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion or, to the Company’s knowledge, engaged in any conduct that would reasonably be expected to result in such debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Without limiting the generality of clause (xvii) above and except as described in the Registration Statement, the U.S. Prospectus and the Canadian Prospectus, neither the Company and its subsidiaries areor any subsidiary, and at all times have been, nor the Company's or any subsidiary's business operations is in material compliance with all violation of any Health Care Laws applicable Laws, except where the failure to biopharmaceutical productsbe in compliance would not reasonably be expected to result in a Material Adverse Effect. For purposes of this Agreement, “"Health Care Laws” " means: (i) the Federal U.S. federal Food, Drug, Drug and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.)Act, and the regulations promulgated thereunder pertaining to biopharmaceutical productsthereunder; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable U.S and Canadian federal, state, local state and foreign health care provincial fraud and abuse laws, including, without limitation, the U.S. federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil U.S. Stark Law (42 U.S.C. Section 1395nn), the U.S. civil False Claims Clxxxx Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the criminal false statements law United States Code and the regulations promulgated pursuant to such statutes; (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under iii) the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), and the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.)regulations promulgated thereunder; (iv) all other local, state, federal, national, supranational the U.S. Controlled Substances Act; (v) Titles XVIII and foreign laws, relating to the regulation XIX of the Company U.S. Social Security Act and the regulations promulgated thereunder; (vi) the U.S. Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and the regulations promulgated thereunder; (vii) quality, safety and accreditation standards and requirements of all applicable state and provincial laws or its subsidiariesregulatory bodies; and (vviii) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor any of their respective employees, officers, directors, or agents has been excluded, suspended or debarred from participation in any U.S. federal other applicable health care program or human clinical research orlaws, regulations, manual provisions, policies and administrative guidance, each of (i) through (viii) as may be amended from time 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 exclusiontime.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times have been, in material compliance with all applicable Health Care Laws applicable to biopharmaceutical productsLaws. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical productsthereunder; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) HIPAA (42 U.S.C. Section 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof, in each case excluding Privacy Laws. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any applicable Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any applicable Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor Company, any of its subsidiaries nor any of their respective employees, officers, directors, or or, to the knowledge of the Company, agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Except as described in each of the Registration Statement or the Prospectus and except as would be reasonably expected to have a Material Adverse Effect on the Company and its subsidiaries, taken as a whole, the Company and its subsidiaries are, and at all times have been, in material compliance with all applicable Health Care Laws applicable to biopharmaceutical productsLaws. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section §§ 301 et seq.), the Public Health Service Act (42 U.S.C. Section §§ 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. False Statements Law (42 U.S.C. § 1320a-7b(a)), the Civil Monetary Penalties Law (42 U.S.C. §1320a-7a), the U.S. Civil False Claims Act (31 U.S.C. Section § 3729 et seq.), the all criminal false statements law (42 U.S.C. Section 1320a-7b(a))laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections §§ 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section §§ 1320d et seq.), the civil monetary penalties law Physician Payments Sunshine Act (42 U.S.C. Section 1320a-7a§ 1320a-7h), the exclusion law (42 U.S.C. Section §1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section §§ 17921 et seq.); (iv) all other local, state, federal, national, supranational and foreign laws, relating regulations promulgated pursuant to the regulation of the Company or its subsidiariessuch statutes; and (v) any and all other applicable federal, state, or foreign health care laws and regulation applicable to the directives and regulations promulgated pursuant to such statutes and ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any state product manufactured or non-U.S. counterpart thereofdistributed by the Company. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity it is in violation of any Health Care Laws norLaws, and, to the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries subsidiaries, nor their respective officers, directors, employees, contractors or agents, is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor any of their respective employees, officers, directors, contractors or agents agents, nor its subsidiaries or any of the subsidiary’s employees, officers, directors, contractors or agents, has been excluded, suspended or debarred from participation in any U.S. federal health care program (as defined in 42 U.S.C. § 1320a-7b(f)) or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in such debarment, suspension, or exclusion. The Company and its subsidiaries have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by the Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were timely, complete, accurate and not misleading on the date filed in all material respects (or were corrected or supplemented by a subsequent submission).

Compliance with Health Care Laws. The Company and its subsidiaries are, (i) is and at all times have been, has been in compliance in all material compliance respects with all Health Care Laws applicable to biopharmaceutical products. For purposes of this Agreement, “Health Care Laws” means: (i) , rules and regulations in the United States or any other jurisdiction, including, without limitation the Federal Food, Drug, Drug and Cosmetic Act (21 U.S.C. Section §301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and all foreign civil and criminal laws relating to health care fraud and abuse lawsabuse, including, without limitation, including but not limited to the federal Anti-Kickback Statute (42 U.S.C. Section §1320a-7b(b)), the Civil civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal false statements law (42 U.S.C. Section §1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section §§ 1320d et seq.), the exclusions law (42 U.S.C. § 1320a-7), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil monetary penalties law (42 U.S.C. Section §1320a-7a), Medicare (Title XVIII of the exclusion law (42 U.S.C. Section 1320a-7Social Security Act), and applicable laws governing government funded or sponsored healthcare programs; Medicaid (iii) Title XIX of the Social Security Act), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (42 U.S.C. Section §§ 17921 et seq.); , the Patient Protection and Affordable Care Act (iv) Pub. Law 111-148), as amended by the Health Care and Education Affordability Reconciliation Act of 2010 (Pub. Law 111-152), the regulations promulgated pursuant to such laws, 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 laws, relating laws applicable to the regulation of the Company ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes and disposal of any state product manufactured or non-U.S. counterpart thereof. Neither distributed by or for the Company nor (collectively, the “Health Care Laws”); (ii) has not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Health Care Laws or Authorizations; (iii) possesses all necessary Authorizations and such Authorizations are valid and in full force and effect and are not in violation of its subsidiaries any term of any such Authorizations; (iv) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have ; (v) has not received any written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take, action to limit, suspend, materially modify or revoke any Authorizations nor is any such limitation, suspension, modification or revocation threatened; (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, 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). Neither the Company ; and (vii) has not, nor have any of its subsidiaries is a party officers or directors, nor, to any corporate integrity agreementsthe knowledge of the Company, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor have any of its subsidiaries nor any of their respective employees, officers, directors, or agents has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or, to the knowledge of the Company, is or subject to a governmental inquiry, investigation, proceeding, or other similar any other action that could reasonably be expected to result in debarment, suspension, or exclusion;.

Compliance with Health Care Laws. The Company and each of its subsidiaries are, and at all times have been, in material compliance with all Health Care Laws applicable to biopharmaceutical products. For purposes of this Agreement, “Health Care Laws” meanssubsidiaries: (i) has operated and currently operates its business in compliance in all material respects with applicable provisions of all applicable health care laws, including Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395hhh (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396v (the Medicaid statute); the Federal Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x); the civil False Claims Act, 31 U.S.C. §§ 3729 et seq.; the criminal False Claims Act 42 U.S.C. 1320a-7b(a); the criminal laws relating to health care fraud and abuse, including 18 U.S.C. Sections 286 and 287 and the health care fraud criminal provisions under HIPAA; the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a and 1320a-7b; the Physician Payments Xxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; the exclusion law, 42 U.S.C. § 1320a-7; HIPAA, as amended by the HITECH Act; the Federal Food, Drug, and Cosmetic Act (Act, 21 U.S.C. Section §§ 301 et seq.), ; the Public Health Service Act (Act, 42 U.S.C. Section §§ 201 et seq.), and ; the FDA’s current good manufacturing practice regulations at 21 CFR Part 211; the regulations promulgated thereunder pertaining pursuant to biopharmaceutical productssuch laws; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all and any similar applicable federal, state, local or foreign laws and foreign health care fraud and abuse lawsregulations of any governmental authority including the Regulatory Agencies applicable to the ownership, includingtesting, without limitationdevelopment, manufacture, packaging, processing, use, sale, distribution, storage, import, export or disposal of any of the Company’s product candidates, but in each case, excluding Privacy Laws (collectively, the Anti“Health Care Laws”); (ii) has not received any United States Food and Drug Administration Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting non-Kickback Statute compliance with (42 U.S.C. Section 1320a-7b(b))A) any Health Care Laws or (B) any licenses, the Civil False Claims Act (31 U.S.C. Section 3729 et seq.)approvals, the criminal false statements law (42 U.S.C. Section 1320a-7b(a))clearances, 18 U.S.C. Sections 286 exemptions, permits, registrations, authorizations, and 287, the health care fraud criminal provisions under the U.S. supplements or amendments thereto required by any such Health Insurance Portability and Accountability Act of 1996 Care Laws (“HIPAARegulatory Authorizations”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAApossesses 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, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.)in any material respect, of any term of any such Regulatory Authorizations; (iv) has fulfilled and performed all other local, state, federal, national, supranational and foreign laws, relating of its material obligations with respect to the regulation Regulatory Authorizations required to conduct its business as currently conducted and, to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment of the Company or its subsidiariesrights of the holder of any such Regulatory Authorization; and (v) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any of its subsidiaries has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (“Proceeding”) from any court governmental authority including any Regulatory Agency or arbitrator or governmental or regulatory authority or any other third party alleging that any product operation or activity is in a material violation of any Health Care Laws noror Regulatory Authorizations or limiting, to the Company’s knowledgesuspending, 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 such claimProceeding; (vi) has filed, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filedobtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, Laws or Regulatory Authorizations (“Reports”) required to conduct its business as currently conducted and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments Reports were materially complete and accurate correct on the date filed in all material respects (or were materially corrected or supplemented by a subsequent submission). Neither ; (vii) along with its employees, officers and directors, and to the Company nor any of its subsidiaries Company’s knowledge, independent contractors and agents, is not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor authority including any of Regulatory Agencies; and (viii) along with its subsidiaries nor any of their respective employees, officers, officers and directors, or agents and to the Company’s knowledge, independent contractors and agents, has not been excluded, suspended or debarred from from, or otherwise rendered ineligible for participation in any U.S. federal government health care program or human clinical research or, research. Any certificate signed by an officer of the Company and delivered to Cowen or to counsel for Cowen pursuant to or in connection with this Agreement shall be deemed to be a representation and warranty by the Company to Cowen as to the knowledge matters set forth therein. The Company acknowledges that Cowen and, for purposes of the Companyopinions to be delivered pursuant to Section 7 hereof, is subject counsel to a governmental inquirythe Company and counsel to Cowen, investigation, proceeding, or other similar action that could reasonably be expected will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to result in debarment, suspension, or exclusionsuch reliance.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times have been, in material compliance with all Health Care Laws applicable to biopharmaceutical products. For purposes of this Agreement, “Health Care Laws” meansmeans all health care laws applicable to the Company and/or its subsidiaries, including, but not limited to, the following laws to the extent applicable: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section § 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law False Claims Law (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) HIPAA (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law exclusion laws (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section § 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.) and similar state and foreign privacy and data security laws such as the GDPR, Medicare (Title XVIII of the Social Security Act); , Medicaid (iv) Title XIX of the Social Security Act), and any and all other similar state, local, state, federal, national, supranational federal or foreign health care laws and foreign laws, relating to the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820 and any state all other laws and regulations applicable to ownership, testing, development, sale, marketing, manufacture, packaging, processing, use, distribution, storage, import, export or non-U.S. counterpart thereofdisposal of the Company’s products, each as amended from time to time. Neither the Company nor any of its subsidiaries has received received, or written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in a material violation of any Health Care Laws norLaws, and, to the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is are a party to or has ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither none of the Company, its subsidiaries, or, to the knowledge of the Company nor any of its subsidiaries nor any of their respective employees, officers, officers or directors, or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human research study or clinical research trial or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, proceeding or other similar action that could would reasonably be expected to result in debarment, suspension, or exclusion. Any certificate signed by any officer or representative of the Company or any of its subsidiaries and delivered to the Agent or counsel for the Agent in connection with an issuance of Shares shall be deemed a representation and warranty by the Company to the Agent as to the matters covered thereby on the date of such certificate. The Company acknowledges that the Agent and, for purposes of the opinions to be delivered pursuant to Section 4(o) hereof, counsel to the Company and counsel to the Agent, will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.

Compliance with Health Care Laws. The Company Except as described in the Registration Statement and its subsidiaries arethe Prospectus, and at all times have been, in material compliance with all Health Care Laws applicable to biopharmaceutical products. For purposes of this Agreement, “Health Care Laws” meansthe Company: (i) to the extent applicable, has operated and currently operates its business in compliance with applicable provisions of the health care laws, including Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395hhh (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396v (the Medicaid statute); the Federal FoodXxxx-Xxxxxxxx Xxxxxxx, Drug00 X.X.X. § 0000x-0x(x); the civil False Claims Act, and Cosmetic Act (21 31 U.S.C. Section 301 §§ 3729 et seq.), ; the Public Health Service criminal False Claims Act (42 U.S.C. Section 201 et seq.1320a-7b(a), and ; the regulations promulgated thereunder pertaining criminal laws relating to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse lawsabuse, including, without limitation, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), including 18 U.S.C. Sections 286 and 287, 287 and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 1996, 42 U.S.C. §§ 1320d et seq., (“HIPAA”) (); the Civil Monetary Penalties Law, 42 U.S.C. Section 1320d et seq.)§§ 1320a-7a; the Physician Payments Xxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; the civil monetary penalties law (exclusion law, 42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section § 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (Act, 42 U.S.C. Section §§ 17921 et seq.); (iv) all other localthe Federal Food, stateDrug, federaland Cosmetic Act, national, supranational and foreign laws, relating to 21 U.S.C. §§ 301 et seq.; the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes laws; and any similar federal, state and local laws and regulations of any governmental authority including the Regulatory Agencies applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any of the Company’s product candidates, (collectively the “Health Care Laws”) except as would not, singly or in the aggregate, result in a Material Adverse Effect; (ii) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting non-U.S. counterpart thereof. Neither 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 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 of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (“Proceeding”) from any court governmental authority including any Regulatory Agency or arbitrator or governmental or regulatory authority or any other third party alleging that any product operation or activity is in a material violation of any Health Care Laws noror Regulatory Authorizations or limiting, to the Company’s knowledgesuspending, 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 such claimProceeding; (v) has filed, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filedobtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, Laws or Regulatory Authorizations (“Reports”) and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments Reports were materially complete and accurate correct on the date filed in all material respects (or were materially corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries ; (vii) is not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor authority including any of Regulatory Agencies; and (viii) along with its subsidiaries nor any of their respective employees, officers, officers and directors, or agents has not been excluded, suspended or debarred from from, or otherwise ineligible for participation in any U.S. federal government health care program or human clinical research or, research. Any certificate signed by any officer or representative of the Company or any of its subsidiaries and delivered to the knowledge Agent or counsel for the Agent in connection with an issuance of Shares shall be deemed a representation and warranty by the Company to the Agent as to the matters covered thereby on the date of such certificate. The Company acknowledges that the Agent and, for purposes of the Companyopinions to be delivered pursuant to Section 4(p) and Section 5(d) hereof, is subject counsel to a governmental inquirythe Company and counsel to the Agent, investigationrespectively, proceeding, or other similar action that could reasonably be expected will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to result in debarment, suspension, or exclusionsuch reliance.

Compliance with Health Care Laws. The Company (a) Neither Seller nor any of its Affiliates or Subsidiaries participate in the United States healthcare programs of Medicare, Medicaid, or their counterparts worldwide, or any other health care programs of a Governmental Authority, or third party payment programs in any jurisdiction (collectively, "Programs") and nor are they a party to participation agreements for payments by such Programs. (b) Neither Seller nor any of its subsidiaries areAffiliates or Subsidiaries has been the subject of any investigation by a Governmental Authority, whether in the United States or overseas, as a result of or in connection with Seller's or any of its Affiliates' or Subsidiary's pricing, production, distribution, marketing or sales activities related to the Products or related services. To Seller's Knowledge, Seller and each of its Affiliates and Subsidiaries have complied in all material respects with all applicable Laws regarding distribution, marketing and sales of Products and services. (c) Seller and each of its Affiliates and Subsidiaries is, and at all times have has been, in material compliance with all Health Care relevant federal and other health care Laws applicable to biopharmaceutical products. For purposes of this Agreementthe Business, “Health Care Laws” means: (i) including the Federal Food, Drug, federal Anti-kickback and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act Fraud and Abuse Prohibition Statutes (42 U.S.C. Section 201 et seq.), § 1320a‑7b) and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical Seller's Knowledge all other Laws prohibiting false statements and improper remuneration for purchasing services or products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal false statements law administrative False Claims Law (42 U.S.C. Section § 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d § 1301 et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a. and implementing regulations), the exclusion law laws, SSA § 1128 (42 U.S.C. Section 1320a-7), ) and applicable the regulations promulgated pursuant to such laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) all other local, state, federal, national, supranational and foreign lawsregulations, relating to the regulation of the Company or its subsidiaries; and Business (v) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any of its subsidiaries has received written notice of any claimcollectively, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any "Health Care Laws"), and all such reportsexcept for failures of compliance that, documentsindividually or in the aggregate, forms, notices, applications, records, claims, submissions and supplements have not or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor any of their respective employees, officers, directors, or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could would not reasonably be expected to result have a Seller Material Adverse Effect, and no change in debarment, suspensionthe current conduct of the Business, or exclusionits internal procedures or processes, is required in order to so comply.

Compliance with Health Care Laws. The (a) Except as disclosed in Section 3.23(a) of the Company Disclosure Letter, Company and its subsidiaries Subsidiaries are, and at all times since January 1, 2008 have been, in material compliance with all Health Care Laws applicable to biopharmaceutical products. For purposes the Medicare statute (Title XVIII of this Agreementthe Social Security Act), “Health Care Laws” means: the Medicaid statute (i) Title XIX of the Federal Social Security Act), the federal Food, Drug, Drug and Cosmetic Act (21 U.S.C. Section §§ 301 et seq.), ) the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), any applicable state fraud and abuse prohibitions, including those that apply to all payors (governmental, commercial insurance and self-payors), the Civil Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal false statements law administrative False Claims Law (42 U.S.C. Section § 1320a-7b(a)), 18 the civil monetary penalty laws (42 U.S.C. Sections 286 and 287§ 1320a-7a), the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section §§ 1320d et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (collectively, “HIPAA”), the exclusion laws (42 U.S.C. Section 17921 et seq.§ 1320a-7); (iv) all other local, state, federal, national, supranational and foreign any comparable state or local laws, relating to and the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes laws, each as amended from time to time, and any other state or non-U.S. counterpart thereoffederal law, regulation, guidance document, manual provision, program memorandum, opinion letter, or other public issuance which regulates kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care programs, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care services (each, a “Health Care Law”). (b) All material reports, documents, claims and notices required to be filed, maintained or furnished to any Governmental Entity by Company and its Subsidiaries have been so filed, maintained or furnished and, to Company’s knowledge, were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). (c) The design, manufacture, testing and distribution of products by or, to Company’s knowledge, on behalf of Company and its Subsidiaries is being, and since January 1, 2008 has been, conducted in compliance in all material respects with all applicable Health Care Laws, including, without limitation, FDA’s current good manufacturing practice regulations at 21 C.F.R. Part 820 for medical device products sold in the United States. (d) Except as disclosed in Section 3.23(d) of the Company Disclosure Letter, since January 1, 2008, Company and its Subsidiaries have not voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notice of action relating to an alleged lack of safety, efficacy or regulatory compliance of any product manufactured, distributed or marketed by or on behalf of Company and its Subsidiaries (each, a “Safety Notice”). Other than with respect to facts and circumstances underlying Safety Notices disclosed in Section 3.23(d) of the Company Disclosure Letter, to Company’s knowledge, as of the date hereof, there are no facts or circumstances which are likely to cause a Safety Notice. Neither the Company nor any of its subsidiaries Subsidiaries has received written any notice that the FDA or other Governmental Entity has (i) commenced, or threatened to initiate, any action to withdraw its investigational device exemption, premarket clearance or premarket approval or request the recall of any claimproduct or product candidate, action(ii) commenced, suitor threatened to initiate, proceeding, hearing, enforcement, investigation, arbitration any action to enjoin manufacture or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that distribution of any product operation or activity is in violation product candidate or (iii) commenced, or threatened to initiate, any action to enjoin the manufacture or distribution of any Health Care Laws norproduct or product candidate produced at any facility where any product or product candidate is manufactured, to the Company’s knowledgetested, is any such claimprocessed, action, suit, proceeding, hearing, enforcement, investigation, arbitration packaged or other action threatened. held for sale. (e) The Company and its subsidiaries Subsidiaries have filednot served as a “Sponsor,” as that term is defined in 21 C.F.R. § 812(n), maintained and their respective products or submitted all material reportsproduct candidates have not been the subject of, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any a clinical study subject to applicable Health Care Laws, including, but not limited to, the federal Food, Drug, and all Cosmetic Act and its applicable implementing regulations. The clinical and pre-clinical studies in which Company and its Subsidiaries have provided support services and related activities, were, and if still pending are, being conducted in accordance with standards and procedures mandated by the pharmaceutical companies and clinical research organizations running such reportsstudies. Company and its Subsidiaries have not received any notice, documentscorrespondence or other communication from the FDA or any other Governmental Entity since January 1, forms2008 requiring the termination or suspension of any such clinical and pre-clinical studies in which Company or any of its Subsidiaries have provided services, noticesas described in the previous sentence. (f) Except as disclosed in Section 3.23(f) of the Company Disclosure Letter, applicationssince January 1, records2008, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the neither Company nor any of its subsidiaries Subsidiaries has received any FDA Form 483, notice of adverse finding, warning letters, untitled letters or other notices alleging a lack of safety from the FDA or any other Governmental Entity, and there is no action or proceeding pending or, to Company’s knowledge, threatened, by any Governmental Entity contesting the investigational device exemption, premarket clearance or approval of, the uses of, of the labeling or promotion of, or otherwise alleging any violation of law with respect to, any product manufactured, distributed or marketed by or on behalf of the Company. (g) Except as disclosed in Section 3.23(g) of the Company Disclosure Letter, Company and its Subsidiaries meet all material requirements of participation, claims submission and payment of Programs and other third party payment programs in which they are participating, whether governmental or commercial, and are a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement ordersvalid participation agreements for payment by such Programs and other third party payment programs. None of Company and its Subsidiaries, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor any of their respective employees, officers, directors, or employees, agents and contractors, has been excluded, suspended or debarred is currently excluded from participation in any U.S. such Program. “Programs” shall mean the Medicare and Medicaid programs (operating under Titles XVIII and XIX of the Social Security Act) and any other state or federal health care program or human clinical research orprogram, 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 as defined in debarment, suspension, or exclusion42 U.S.C. § 1320a-7b(f).

Compliance with Health Care Laws. The Company and each of its subsidiaries are, Subsidiaries (i) is and at all times have been, has been in compliance in all material compliance respects with all Health Care Laws applicable to biopharmaceutical products. For purposes of this Agreement, “Health Care Laws” means: (i) , rules and regulations in the United States or any other jurisdiction, including, without limitation the Federal Food, Drug, Drug and Cosmetic Act (21 U.S.C. Section §301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign civil and criminal laws relating to health care fraud and abuse lawsabuse, including, without limitation, including but not limited to the federal Anti-Kickback Statute (42 U.S.C. Section §1320a-7b(b)), the Civil civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal false statements law (42 U.S.C. Section §1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section §§ 1320d et seq.), the exclusions law (42 U.S.C. § 1320a-7), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil monetary penalties law (42 U.S.C. Section §1320a-7a), Medicare (Title XVIII of the exclusion law (42 U.S.C. Section 1320a-7Social Security Act), and applicable laws governing government funded or sponsored healthcare programs; Medicaid (iii) Title XIX of the Social Security Act), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”) (42 U.S.C. Section §§ 17921 et seq.); , the Patient Protection and Affordable Care Act (iv) Pub. Law 111-148), as amended by the Health Care and Education Affordability Reconciliation Act of 2010 (Pub. Law 111-152), the regulations promulgated pursuant to such laws, 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 laws, relating laws applicable to the regulation of the Company ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes and disposal of any state product under development, manufactured or non-U.S. counterpart thereof. Neither distributed by or for the Company nor (collectively, the “Health Care Laws”); (ii) has not received any FDA Form 483, notice of its subsidiaries adverse finding, warning letter, untitled letter, or other correspondence or notice from the FDA or any other correspondence or notice from any other Regulatory Authority or Governmental Entity or third party alleging or asserting noncompliance with any Health Care Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such applicable laws (“Authorizations”); (iii) possesses 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; (iv) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any court or arbitrator or governmental or regulatory authority Governmental Entity or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to or Authorizations and has no knowledge that the Company’s knowledge, FDA or any Governmental Entity or third party is considering any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action; (v) has not received any notice that the FDA or any Governmental Entity or third party has taken, is taking or intends to take, action threatened. The Company to limit, suspend, materially modify or revoke any Authorizations and its subsidiaries have has no knowledge that the FDA or any Governmental Entity or third party is considering any such limitation, suspension, modification or revocation; (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, 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). Neither the Company ; and (vii) has not, nor have any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements shareholders with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor any of their respective employeesmore than five (5) percent interest, officers, directors, directors or agents has employees been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or, to the knowledge of the Company, is or subject to a governmental inquiry, investigation, proceeding, or other similar any other action that could would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries subsidiaries, and to the Company’s knowledge their respective officers, directors, employees, and agents, are, and at all times have been, in compliance in all material compliance respects with all Health Care Laws Laws, to the extent applicable to biopharmaceutical productsthe business of the Company and its subsidiaries. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical productsthereunder; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law False Statements Law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 286, 287, and 1349, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion exclusions law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C Section 1320-7h), and applicable the laws governing U.S. government funded or sponsored healthcare programs; (iii) HIPAA, HIPAA as amended by amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.)Act; (iv) all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries; and (v) laws the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof; and (v) all other local, state, federal, and foreign laws applicable to the regulation of 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 under development, manufactured or distributed by or for the Company or any of its subsidiaries. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company Company, and to the Company’s knowledge, its subsidiaries subsidiaries, have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor Company, any of its subsidiaries subsidiaries, nor, to the Company’s knowledge, any of their respective employees, officers, directors, or agents is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor Company, any of its subsidiaries nor nor, to the Company’s knowledge, any of their respective employees, officers, ​ ​ directors, or agents has been excluded, suspended suspended, or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and to the Company’s knowledge, at all times have been, in material compliance with all Health Care Laws applicable to biopharmaceutical productsthe business of the Company. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical productsthereunder; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 at 18 U.S.C. Section 1320d et seq.)Sections 1347 and 1035, the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), and applicable laws governing government funded or sponsored healthcare programsthe Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and the Medicare and Medicaid coverage and reimbursement provisions of Titles XVIII and XIX of the Social Security Act; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (v) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries; , and (vvi) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor Company, any of its subsidiaries nor any of their respective employees, officers, directors, or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times during the last three years have been, in material compliance compliance, and have taken any required and necessary actions to comply, with all Health Care Laws applicable Laws, except where noncompliance would not singly or in the aggregate reasonably be expected to biopharmaceutical productsresult in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” meansmeans all health care laws applicable to the Company or any of its subsidiaries, including, but not limited to: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.)Act, the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the U.S. Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law False Claims Act (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law exclusion laws (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section § 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); , Medicare (iv) Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and any and all other similar state, local, state, federal, national, supranational federal or foreign (including Israeli) health care laws and foreign laws, relating to the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820 and all other laws and regulations applicable to ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of the Company’s or any state or non-U.S. counterpart thereofof its subsidiaries’ products, each as amended from time to time. Neither the Company nor any of its subsidiaries has received any Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA, or written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party Governmental Authority alleging that any product operation or activity is in a material violation of any Health Care Laws norLaws, and, to the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to or has ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authorityGovernmental Authority. Additionally, neither the Company nor any of its subsidiaries nor subsidiaries, nor, to the knowledge of the Company, any of their respective its or its subsidiaries’ employees, officers, directors, officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human research study or clinical research trial or, to the knowledge of the Company, is subject to a governmental an inquiry, investigation, proceeding, or other similar action by any Governmental Authority that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, are and at all times have been, been in material compliance with all Health Care Laws applicable (as hereinafter defined), except where instances of non-compliance would not, singly or in the aggregate, reasonably be expected to biopharmaceutical productsresult in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” meansmeans all health care laws applicable to the Company, including, but not limited to: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitationAct, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law False Claims Law (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law exclusion laws (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section § 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); , Medicare (iv) Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and any and all other local, similar state, federal, national, supranational local or federal health care laws and foreign laws, relating to the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820, and all other laws and regulations applicable to ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of the Company’s products, each as amended from time to time. The Company and its subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or non-U.S. counterpart thereoffederal health care program, except where such noncompliance, false claims liability or civil penalties would not reasonably be expected to, singly or in the aggregate, result in a Material Adverse Effect. Neither the Company nor any of its subsidiaries has have 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 a material violation of any Health Care Laws norLaws, and, to the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is are a party to and have ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor subsidiaries, to the knowledge of the Company, any of their respective its employees, officers, directors, officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal health care program program, clinical trial or human clinical research registry or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion. Except as described in the Registration Statement, the General Disclosure Package or the Prospectus or as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect, neither the Company nor any of its subsidiaries have received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting noncompliance with (x) any Health Care Laws or (y) any Governmental Licenses required by any such Health Care Laws.

Compliance with Health Care Laws. The Company and its subsidiaries aresubsidiaries, if any, are and at all times have been, been in material compliance with all applicable Health Care Laws applicable Laws, except where the failure to biopharmaceutical productsdo so would not reasonably be expected to have, singly or in the aggregate, a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), and the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical productsthereunder; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the U.S. civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law claims Law (42 U.S.C. Section § 1320a-7b(a)), 18 U.S.C. Sections 286 286, 287, 1347 and 2871349, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7) and the civil monetary penalties law (42 U.S.C. Section § 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes statutes; (iv) Medicare (Title XVIII of the Social Security Act); (v) Medicaid (Title XIX of the Social Security Act); and (vi) any state and all other applicable similar or non-U.S. counterpart thereofcomparable health care laws and regulations. Neither the Company nor any of its subsidiaries has subsidiaries, if any, have 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 court, arbitrator, Governmental Entity or third party alleging that any product operation or activity is in material violation of any Health Care Laws norLaws, and, to the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor any of their respective employees, officers, directors, or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times during the last three years have been, in material compliance compliance, and have taken any required and necessary actions to comply, with all Health Care Laws applicable Laws, except where noncompliance would not singly or in the aggregate reasonably be expected to biopharmaceutical productsresult in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” meansmeans all health care laws applicable to the Company or any of its subsidiaries, including, but not limited to: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.)Act, the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the U.S. Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law False Claims Act (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law exclusion laws (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section § 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); , Medicare (iv) Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and any and all other similar state, local, state, federal, national, supranational federal or foreign (including Israeli) health care laws and foreign laws, relating to the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820 and all other laws and regulations applicable to ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of the Company’s or any state or non-U.S. counterpart thereofof its subsidiaries’ products, each as amended from time to time. Neither the Company nor any of its subsidiaries has received any Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA, or written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in a material violation of any Health Care Laws norLaws, and, to the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to or has ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor subsidiaries, nor, to the knowledge of the Company, any of their respective its or its subsidiaries’ employees, officers, directors, officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human research study or clinical research trial or, to the knowledge of the Company, is subject to a governmental an inquiry, investigation, proceeding, or other similar action by any governmental authority that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company In the past three years, the Company, XXXX XX and its the Company’s subsidiaries are, and have operated at all times have been, and are currently in material compliance with all Health Care Laws applicable except where failure to biopharmaceutical productsbe in compliance would not have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, includingsuch as, without limitationto the extent applicable, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law False Statements Law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 286, and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law Civil Monetary Penalties Law (42 U.S.C. Section 1320a-7a), and the exclusion law (42 U.S.C. Section 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iiiii) to the extent applicable, HIPAA, as amended by the Health Information Technology for Economic HITECH Act; (iii) licensure, quality, safety and Clinical Health Act (42 U.S.C. Section 17921 et seq.)accreditation requirements under applicable federal, state, local and foreign laws and regulatory bodies; and (iv) all other applicable local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company Company, XXXX XX and the Company’s subsidiaries and the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or its disposal of any product under development, manufactured or distributed by the Company, XXXX XX or the Company’s subsidiaries; and (v) . In the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither past three years, neither the Company Company, XXXX XX nor any of its the Company’s subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product product, operation or activity is in material violation of any Health Care Laws nor, to the Company’s or ATAI AG’s knowledge, is any such claimAction threatened, actionexcept where such action would not, suitindividually or in the aggregate, proceedinghave a Material Adverse Effect. In the past three years, hearingexcept as would not, enforcementindividually or in the aggregate, investigationhave a Material Adverse Effect, arbitration or other action threatened. The Company the Company, XXXX XX and its the Company’s subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, claims submissions and supplements or amendments as required by any applicable Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company Company, XXXX XX nor any of its the Company’s subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither in the Company nor any past three years, none of its the Company, XXXX XX, the Company’s subsidiaries nor or any of their respective employees, officers, directors, or to the Company’s or ATAI AG’s knowledge, their agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the CompanyCompany or XXXX XX, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company’s and its subsidiaries’ business are operated in a manner intended to comply with the state, federal and foreign health care laws applicable to the respective businesses of the Company and its subsidiaries, and the Company and its subsidiaries are, and at are in compliance in all times have been, in material compliance respects with all applicable Health Care Laws applicable to biopharmaceutical productsLaws. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical productsthereunder; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the U.S. civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law claims Law (42 U.S.C. Section § 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7) and the civil monetary penalties law (42 U.S.C. Section § 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes statutes; (iv) the Patient Protection and Affordable Care Act (Public Law 111-148), as amended by the Health Care and Education Reconciliation Act (Public Law 111-152; (v) Medicare (Title XVIII of the Social Security Act); (vi) Medicaid (Title XIX of the Social Security Act); and (vii) any state or non-U.S. counterpart thereofand all other applicable health care laws and regulations. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws norLaws, and, to the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries 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 health care program or federal health care program. Neither the Company nor its 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 or regulatory authority. Additionally, neither none of the Company nor any of Company, its subsidiaries nor subsidiary or any of their respective employees, officers, directors, officers or agents 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 218136659 v11 Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Except as would not result, individually or in the aggregate, in a Material Adverse Effect, the Company and its subsidiaries are, are and at all times have been, been in material compliance with all applicable Health Care Laws applicable to biopharmaceutical productsLaws. For purposes of this Agreement, “Health Care Laws” meansmeans all health care laws applicable to the Company, including, but not limited to: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitationAct, the Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payment Sunshine Act (42 U.S.C. § 1320a- 7h), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law False Claims Law (42 U.S.C. Section § 1320a-7b(a)), the Clinical Laboratory Improvement Act of 1988 (42 U.S.C. § 263a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section § 1320d et seq.), the civil monetary penalties law exclusion laws (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section § 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section § 17921 et seq.); , Medicare (iv) Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and any and all other local, similar state, federal, national, supranational local or federal health care laws and foreign laws, relating to the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes laws, including, without limitation, the U.S. Food and Drug Administration (the “FDA”)’s current good manufacturing practice regulations at 21 CFR Part 820, and all other laws and regulations applicable to ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of the Company’s products, each as amended from time to time. The Company and its subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or non-U.S. counterpart thereoffederal health care program, except where such noncompliance, false claims liability or civil penalties would not reasonably be expected to, individually or in the aggregate, have a Material Adverse Effect. Neither the Company nor any of its subsidiaries has have 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 a material violation of any Health Care Laws norLaws, and, to the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened, that, individually or in the aggregate, if determined adversely to the Company or any of its subsidiaries, would reasonably be expected to have a Material Adverse Effect. The Company and its subsidiaries have filedExcept for a Corporate Integrity Agreement executed with the Office of Inspector General dated June 29, maintained or submitted all material reports2020, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither neither the Company nor any of its subsidiaries is are a party to and have ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor subsidiaries, to the knowledge of the Company, any of their respective its employees, officers, directors, officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal health care program program, clinical trial or human clinical research registry or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion. Except as described in the Time of Sale Information or the Offering Memorandum or as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, neither the Company nor any of its subsidiaries have received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting noncompliance with (x) any Health Care Laws or (y) any Governmental Licenses required by any such Health Care Laws.

Compliance with Health Care Laws. The Except as would not reasonably be expected to result in a Material Adverse Change, the Company and its subsidiaries areSubsidiaries and, to the Company’s knowledge, its and its Subsidiaries’ directors, employees and agents (while acting in such capacity) are and at all times have been, been in material compliance with all Health Care Laws health care laws, rules, and regulations applicable to biopharmaceutical products. For purposes the Company, its Subsidiaries, or any of this Agreementits products or product candidates or activities or operations as of the date hereof, “including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), the civil False Claims Act (31 U.S.C. Section 3729 et seq.), the administrative False Claims Law (42 U.S.C. Section 1320a-7b(a)), the Xxxxx law (42 U.S.C. Section 1395nn), the Physician Payments Sunshine Act (42 U.S.C. Section 1320a-7h), the Health Care Laws” means: Insurance Portability and Accountability Act of 1996 (i42 U.S.C. Section 1320d et seq.) as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and Medicare (Title XVIII of the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)Social Security Act), Medicaid (Title XIX of the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7Social Security Act), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAAthe Patient Protection and Affordable Care Act of 2010, as amended by the Health Information Technology for Economic Care and Clinical Health Education Reconciliation Act (42 U.S.C. Section 17921 et seq.); (iv) all other localof 2010, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes laws, and any state other similar state, federal or non-U.S. counterpart thereofforeign law (collectively, “Health Care Laws”). Neither the The Company nor has not received any of its subsidiaries has received written notice notification, correspondence or any other communication, including notification of any pending or threatened 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 Regulatory Agency, including, without limitation, the FDA, the U.S. Federal Trade Commission, CMS, HHS’s Office of Inspector General, the U.S. Department of Justice and state Attorneys General or similar agencies of potential or actual non-compliance by, or liability of, the Company or any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by Subsidiaries under any Health Care Laws, except, with respect to any of the foregoing, such as would not, individually or in the aggregate, result in a Material Adverse Change. The statements with respect to Health Care Laws and all such reports, documents, forms, notices, applications, records, claims, submissions the Company’s compliance therewith included or incorporated by reference in the Prospectus are true and supplements or amendments were complete and accurate on the date filed correct in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor any of their respective employees, officers, directors, or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusionrespects.

Compliance with Health Care Laws. The Company is and its subsidiaries are, and at all times have been, has been in material compliance with all Health Care Laws applicable (as hereinafter defined), except where instances of non-compliance would not, singly or in the aggregate, reasonably be expected to biopharmaceutical productsresult in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” meansmeans all health care laws applicable to the Company, including, but not limited to: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitationAct, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law False Claims Law (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law exclusion laws (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section § 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); , Medicare (iv) Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and any and all other local, similar state, federal, national, supranational local or federal health care laws and foreign laws, relating to the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820, and all other laws and regulations applicable to ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of the Company’s products, each as amended from time to time. The Company has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or non-U.S. counterpart thereoffederal health care program, except where such noncompliance, false claims liability or civil penalties would not reasonably be expected to, singly or in the aggregate, result in a Material Adverse Effect. Neither the The Company nor any of its subsidiaries has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in a material violation of any Health Care Laws norLaws, and, to the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is not a party to and has no ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor nor, to the knowledge of the Company, any of its subsidiaries nor any of their respective employees, officers, directors, officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal health care program program, clinical trial or human clinical research registry or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion. Except as described in the Registration Statement, the General Disclosure Package or the Prospectus or as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting noncompliance with (x) any Health Care Laws or (y) any Governmental Licenses required by any such Health Care Laws.

Compliance with Health Care Laws. The Neither the Company and its subsidiaries areor any subsidiary, and at all times have been, nor the Company’s or any subsidiary’s business operations is in material compliance with all violation of any Health Care Laws applicable Laws, except where such violation would not reasonably be expected to biopharmaceutical productsresult in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: means (i) the Federal Food, Drug, federal and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care state fraud and abuse lawslaws referred to generally or specifically in the Prospectus, including, without limitationbut not limited to, the federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b§ 1320a-7(b)), the Civil Xxxxx Law (42 U.S.C. § 1395nn and § 1395(q)), the civil False Claims Act (31 U.S.C. Section § 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the criminal false statements law United States Code and the regulations promulgated pursuant to such statutes; (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, ii) the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”Pub. L. No. 104-191) (42 U.S.C. Section 1320d et seq.)and the regulations promulgated thereunder, the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by Medicare (Title XVIII of the Health Information Technology for Economic Social Security Act) and Clinical Health Act (42 U.S.C. Section 17921 et seq.)the regulations promulgated thereunder; (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation Medicaid (Title XIX of the Company or its subsidiariesSocial Security Act) and the regulations promulgated thereunder; and (v) the directives Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. No. 108-173) and the regulations promulgated pursuant thereunder; (vi) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (vii) any and all other applicable federal, state, or foreign health care laws or regulations, each of (i) through (vii) as may be amended from time to such statutes and any state time. Notwithstanding the foregoing or non-U.S. counterpart thereof. Neither anything herein to the contrary, the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration makes no representations or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to warranties regarding compliance by the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements physician customers with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor any of their respective employees, officers, directors, or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusionapplicable laws.

Compliance with Health Care Laws. The To the extent applicable to the Company and its business, the Company and its subsidiaries are, and at all times have been, in compliance in all material compliance respects with all Health Care Laws applicable to biopharmaceutical productsLaws. For purposes of this Agreement, “Health Care Laws” meansmeans the following, in each case as applicable to the Company or its subsidiaries: (i) the Federal Foodapplicable FDA Laws, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. civil monetary penalties law (42 U.S.C. § 1320a-7a), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the U.S. criminal false statements law (42 U.S.C. Section § 1320a-7b(a)), all applicable federal, state, local and all foreign criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the U.S. exclusion law (42 U.S.C. Section § 1320a-7), the statutes, regulations and directives of applicable laws governing government funded or sponsored healthcare programs; , and the regulations promulgated pursuant to such statutes, (iii) applicable requirements under HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof, (iv) the U.S. Patient Protection and Affordable Care Act of 2010 (Public Law 111-148), as amended by the U.S. Health Care and Education Reconciliation Act of 2010 (Public Law 111-152), the regulations promulgated thereunder; (ivv) the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), (vi) the U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.) and (vii) all other local, state, federal, national, supranational and foreign laws, relating laws applicable to the regulation of the Company or and its subsidiaries; . The Company and (v) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any of its subsidiaries has have not received written notice of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court Governmental Authority alleging potential or arbitrator actual non-compliance by, or governmental liability of, the Company or regulatory authority or third party alleging that any product operation or activity is in violation of subsidiary under any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedLaws. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments thereof as required by any applicable Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor any of their respective employees, officers, directors, or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and each of its subsidiaries are, Subsidiaries (i) is and at all times have been, has been in compliance in all material compliance respects with all Health Care Laws applicable to biopharmaceutical products. For purposes of this Agreement, “Health Care Laws” means: (i) , rules and regulations in the United States or any other jurisdiction, including, without limitation the Federal Food, Drug, Drug and Cosmetic Act (21 U.S.C. Section §301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and all foreign civil and criminal laws relating to health care fraud and abuse lawsabuse, including, without limitation, including but not limited to the federal Anti-Kickback Statute (42 U.S.C. Section §1320a-7b(b)), the Civil civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal false statements law (42 U.S.C. Section §1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section §§ 1320d et seq.), the exclusions law (42 U.S.C. § 1320a-7), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil monetary penalties law (42 U.S.C. Section §1320a-7a), Medicare (Title XVIII of the exclusion law (42 U.S.C. Section 1320a-7Social Security Act), and applicable laws governing government funded or sponsored healthcare programs; Medicaid (iii) Title XIX of the Social Security Act), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”) (42 U.S.C. Section §§ 17921 et seq.); , the Patient Protection and Affordable Care Act (iv) Pub. Law 111-148), as amended by the Health Care and Education Affordability Reconciliation Act of 2010 (Pub. Law 111-152), the regulations promulgated pursuant to such laws, 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 laws, relating laws applicable to the regulation of the Company ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes and disposal of any state product under development, manufactured or non-U.S. counterpart thereof. Neither distributed by or for the Company nor (collectively, the “Health Care Laws”); (ii) has not received any FDA Form 483, notice of its subsidiaries adverse finding, warning letter, untitled letter, or other correspondence or notice from the FDA or any other correspondence or notice from any other Regulatory Authority or Governmental Entity or third party alleging or asserting noncompliance with any Health Care Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such applicable laws (“Authorizations”); (iii) possesses 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; (iv) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any court or arbitrator or governmental or regulatory authority Governmental Entity or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to or Authorizations and has no knowledge that the Company’s knowledge, FDA or any Governmental Entity or third party is considering any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action; (v) has not received any notice that the FDA or any Governmental Entity or third party has taken, is taking or intends to take, action threatened. The Company to limit, suspend, materially modify or revoke any Authorizations and its subsidiaries have has no knowledge that the FDA or any Governmental Entity or third party is considering any such limitation, suspension, modification or revocation; (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, 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). Neither the Company ; and (vii) has not, nor have any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements shareholders with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor any of their respective employeesmore than five (5) percent interest, officers, directors, directors or agents has employees been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or, to the knowledge of the Company, is or subject to a governmental inquiry, investigation, proceeding, or other similar any other action that could would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company Except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect or except as disclosed in the Registration Statement, the General Disclosure Package and its subsidiaries arethe Prospectus, and at all times have beenneither the Company, nor the Company’s business operations, is in material compliance with all violation of any Health Care Laws applicable to biopharmaceutical productsLaws. For purposes of this Agreement, “"Health Care Laws” means: " means (iA) all federal and state fraud and abuse laws, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), the Xxxxx Law (42 U.S.C. §1395nn and §1395(q)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the civil False Claims Act (31 X.X.X. §0000 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalty laws (42 U.S.C. § 1320a-7a) and the regulations promulgated pursuant to such statutes, (B) the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191) and the Health Information Technology for Economic and Clinical Health Act of 2009, and the regulations promulgated thereunder and comparable state privacy and security laws, (C) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder, (D) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder, (E) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section § 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), ) and the regulations promulgated thereunder pertaining to biopharmaceutical products; pursuant thereto, (iiF) to the extent applicable to pre-commercial biopharmaceutical productsquality, safety and accreditation standards and requirements of all applicable federal, state, local state laws or regulatory bodies and foreign (G) any and all other applicable health care fraud and abuse laws, includingregulations, without limitationmanual provisions, policies and administrative guidance, each of (A) through (G) as may be amended from time to time. Except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect or except as disclosed in the Registration Statement, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b))General Disclosure Package and the Prospectus, the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any of its subsidiaries has 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 Governmental Entity alleging that any product product, operation or activity is in violation of any applicable Health Care Laws nor, to the Company’s knowledge, Law or permit and has no knowledge that any such Governmental Entity is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company ; and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor has not received notice, either verbally or in writing, that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any permits and has no knowledge that any such Governmental Entity is considering such action, except for any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor any of their respective employees, officers, directors, or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action foregoing that could would not reasonably be expected to result in debarment, suspension, or exclusiona Material Adverse Effect.

Compliance with Health Care Laws. The Company and its subsidiaries areis, and at all times have has been, in compliance in all material compliance respects with all Health Care Laws to the extent applicable to biopharmaceutical productsthe Company or its business. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), and the Public Health Service Act (42 U.S.C. Section 201 et seq.)Act, and the regulations promulgated thereunder pertaining to biopharmaceutical productsthereunder; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law False Statements Law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 286, 287, 1035, 1347, and 1349 the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) HIPAA (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion exclusions law (42 U.S.C. Section 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act HITECH Act, (42 U.S.C. Section 17921 et seq.); (iv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; (vi) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries; Company, and (vvii) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither The Company and its officers, directors, employees and, to the knowledge of the Company, its agents have not engaged in activities which are, as applicable, cause for liability under a Health Care Law. The Company nor any of its subsidiaries has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any its employees, officers, directors, or, to the knowledge of the Company, its subsidiaries agents is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityauthority related to activities conducted by or on behalf of the Company. Additionally, neither the Company nor any of its subsidiaries nor any of their respective employees, officers, directors, or or, to the knowledge of the Company, its agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company’s and its subsidiaries’ business are operated in a manner intended to comply with the state, federal and foreign health care laws applicable to the respective businesses of the Company and its subsidiaries, and the Company and its subsidiaries are, and at are in compliance in all times have been, in material compliance respects with all applicable Health Care Laws applicable to biopharmaceutical productsLaws. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical productsthereunder; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the U.S. civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law claims Law (42 U.S.C. Section § 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7) and the civil monetary penalties law (42 U.S.C. Section § 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes statutes; (iv) the Patient Protection and Affordable Care Act (Public Law 111-148), as amended by the Health Care and Education Reconciliation Act (Public Law 111-152; (v) Medicare (Title XVIII of the Social Security Act); (vi) Medicaid (Title XIX of the Social Security Act); and (vii) any state or non-U.S. counterpart thereofand all other applicable health care laws and regulations. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws norLaws, and, to the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries 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 health care program or federal health care program. Neither the Company nor its 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 or regulatory authority. Additionally, neither none of the Company nor any of Company, its subsidiaries nor subsidiary or any of their respective employees, officers, directors, officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, subsidiary are and at all times have been, been in material compliance with all Health Care Laws applicable (as defined below), except where such noncompliance would not, singly or in the aggregate, reasonably be expected to biopharmaceutical productsresult in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) means all health care laws applicable to the Company and/or its subsidiary, including, but not limited to, the following laws to the extent applicable, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitationAct, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law False Claims Law (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law exclusion laws (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section § 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.) and similar state and foreign privacy and data security laws such as the European Union General Data Protection Regulation and California Consumer Privacy Act, Medicare (Title XVIII of the Social Security Act); , Medicaid (iv) Title XIX of the Social Security Act), and any and all other similar state, local, state, federal, national, supranational federal or foreign health care laws and foreign laws, relating to the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820 and any state all other laws and regulations applicable to ownership, testing, development, sale, marketing, manufacture, packaging, processing, use, distribution, storage, import, export or non-U.S. counterpart thereofdisposal of the Company’s products, each as amended from time to time. Neither the Company nor any of its subsidiaries subsidiary has received any Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA, or other 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 a material violation of any Health Care Laws noror Governmental Licenses, and, to the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries subsidiary is a party to or has ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither none of the Company nor any of Company, its subsidiaries nor any of their subsidiary or its respective employees, officers, officers or directors, or agents or, to the knowledge of the Company, agents, has been excluded, suspended or debarred from participation in any U.S. federal health care program or human research study or clinical research trial or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, proceeding or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times during the last three years have been, in material compliance compliance, and have taken any required and necessary actions to comply, with all Health Care Laws applicable Laws, except where noncompliance would not singly or in the aggregate reasonably be expected to biopharmaceutical productsresult in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” meansmeans all health care laws applicable to the Company or any of its subsidiaries, including, but not limited to: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.)Act, the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. Sec. 1320a-7a), the U.S. Physician Payment Sunshine Act (42 U.S.C. Sec. 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law False Claims Act (42 U.S.C. Section Sec. 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 health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law exclusion laws (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section Sec. 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); , Medicare (iv) Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and any and all other similar state, local, state, federal, national, supranational federal or foreign (including Israeli) health care laws and foreign laws, relating to the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820 and all other laws and regulations applicable to ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of the Company’s or any state or non-U.S. counterpart thereofof its subsidiaries’ products, each as amended from time to time. Neither the Company nor any of its subsidiaries has received any Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA, or written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in a material violation of any Health Care Laws norLaws, and, to the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to or has ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither none the Company nor or any of its subsidiaries nor subsidiaries, or, to the knowledge of the Company, any of their respective its or its subsidiaries’ employees, officers, directors, officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human research study or clinical research trial or, to the knowledge of the Company, is subject to a governmental an inquiry, investigation, proceeding, or other similar action by any governmental authority that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Without limiting the generality of clause (xvii) above and except as described in the Registration Statement, the U.S. Prospectus and the Canadian Prospectus, neither the Company and or its subsidiaries aresubsidiary, and at all times have been, nor the Company’s or its subsidiary’s business operations is in material compliance with all violation of any Health Care Laws applicable Laws, except where the failure to biopharmaceutical productsbe in compliance would not reasonably be expected to result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal U.S. federal Food, Drug, Drug and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.)Act, and the regulations promulgated thereunder pertaining to biopharmaceutical productsthereunder; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable U.S. and Canadian federal, state, local state and foreign health care provincial fraud and abuse laws, including, without limitation, the U.S. federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b§1320a7b(b)), the Civil U.S. Xxxxx Law (42 U.S.C. §1395nn), the U.S. civil False Claims Act (31 U.S.C. Section 3729 X.X.X. §0000 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the criminal false statements law United States Code and the regulations promulgated pursuant to such statutes; (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under iii) the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), and the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.)regulations promulgated thereunder; (iv) all other local, state, federal, national, supranational the U.S. Controlled Substances Act; (v) Titles XVIII and foreign laws, relating to the regulation XIX of the Company U.S. Social Security Act and the regulations promulgated thereunder; (vi) the U.S. Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and the regulations promulgated thereunder; (vii) quality, safety and accreditation standards and requirements of all applicable state and provincial laws or its subsidiariesregulatory bodies; and (vviii) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor any of their respective employees, officers, directors, or agents has been excluded, suspended or debarred from participation in any U.S. federal other applicable health care program or human clinical research orlaws, regulations, manual provisions, policies and administrative guidance, each of (i) through (viii) as may be amended from time 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 exclusiontime.

Compliance with Health Care Laws. The Company and, to the Company’s knowledge, its directors, employees and its subsidiaries are, agents (while acting in such capacity) are and at all times have been, been in material compliance with with, all Health Care Laws health care laws applicable to biopharmaceutical products. For purposes the Company, or any of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse lawsits products or activities, including, without limitationbut not limited to, the federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), the civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law administrative False Claims Law (42 U.S.C. Section 1320a-7b(a)), 18 the Xxxxx law (42 U.S.C. Sections 286 and 287Section 1395nn), the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); , the exclusion laws (iv) all other local42 U.S.C. Section 1320a-7), statethe Federal Food, federalDrug, nationaland Cosmetic Act (21 U.S.C. Section 301 et seq.), supranational and foreign lawsthe Controlled Substances Act (21 U.S.C. Section 801 et seq.), relating to the regulation Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Company or its subsidiaries; Social Security Act), Medicaid (Title XIX of the Social Security Act), and (v) the directives 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 statutes laws, and any state other state, federal or non-U.S. counterpart thereofforeign law, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes legally binding requirements on manufacturing, development, testing, labeling, advertising, marketing, promotion, distribution, reporting, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care programs, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, “Health Care Laws”). Neither the The Company nor has not received any of its subsidiaries has received notification, correspondence or any other written notice or oral communication, including notification of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court governmental authority, including, without limitation, the FDA, the EMA, Health Canada, the U.S. Federal Trade Commission, the U.S. Drug Enforcement Administration, CMS, HHS’s Office of Inspector General, the U.S. Department of Justice and state Attorneys General or arbitrator similar agencies of potential or governmental actual non-compliance by, or regulatory authority or third party alleging that any product operation or activity is in violation of liability of, the Company under any Health Care Laws norLaws, except, with respect to any of the foregoing, such as would not, individually or in the aggregate, result in a Material Adverse Effect. To the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration there are no facts or other action threatened. The circumstances that would reasonably be expected to give rise to material liability of the Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by under any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company Company, nor any of its subsidiaries Subsidiaries, is a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, monitoring agreements, deferred prosecution agreements, consent decrees, settlement orders, plan of correction or similar agreements with or imposed by any governmental or regulatory authorityauthority for non-compliance with any Health Care Law. Additionally, neither the Company nor any of its subsidiaries nor any of their respective employees, officers, directors, or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, The statements with respect to the knowledge of Health Care Laws and the Company’s compliance therewith included in the Registration Statement, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusionthe Time of Sale Prospectus and the Prospectus fairly summarize the matters therein described.

Compliance with Health Care Laws. The Company and its subsidiaries areis, and at all times have has been, in material compliance with all applicable Health Care Laws applicable to biopharmaceutical productsLaws, and has not engaged in activities which are, as applicable, cause for false claims liability or civil penalties, except where such noncompliance, false claims liability or civil penalties would not reasonably be expected to, singly or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” meansmeans all health care laws applicable to the Company, including, but not limited to: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law False Claims Law (42 U.S.C. Section § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law exclusion laws (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section § 1320a-7), Basic Health and applicable laws governing government funded or sponsored healthcare programs; (iii) Human Services Policy for Protection of Human Research Subjects “Common Rule” as codified and enforced by the Department of Health and Human Services in 45 C.F.R. part 46 and enforced by FDA under 21 C.F.R. part 50, Laboratory Animal Welfare Act of 1966, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) any and all other applicable comparable local, state, federal, national, supranational and foreign laws, relating to health care laws and the regulation of the Company or its subsidiaries; and (v) the directives and regulations promulgated pursuant to such statutes and laws, each as amended from time to time; for the avoidance of doubt Health Care Laws excludes any state U.S. federal laws, statutes, codes, ordinances, decrees, rules or non-U.S. counterpart thereofregulations which apply to the production, trafficking, distribution, processing, extraction, sale and/or possession of cannabis, marijuana, psilocybin or related substances, products or synthetic compounds containing or related to same, including, but not limited to, the prohibition on drug trafficking under 21 U.S.C. §841(a). Neither the The Company nor any of its subsidiaries has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws norLaws, and, to the knowledge of the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company and its subsidiaries have filedhas not received any written notice of adverse filing, maintained warning letter, untitled letter or submitted all other correspondence or notice from the FDA, the European Commission, the EMA or any other Health Regulatory Agencies, or any other court or arbitrator, alleging or asserting material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any noncompliance with the Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the The Company nor any of its subsidiaries is not a party to and has no ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor Company, nor, to the knowledge of the Company, any of its subsidiaries nor any of their respective employees, officers, directors, officers or agents directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research study or trial or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, suspension or exclusion.

Compliance with Health Care Laws. The Company and its subsidiaries Subsidiaries, and to the Company’s knowledge, their respective directors, officers and employees, are, and at all times have been, in material compliance with all applicable Health Care Laws applicable (as defined herein) including, but not limited to, the rules and regulations of the FDA, the U.S. Department of Health and Human Services Office of Inspector General, the Centers for Medicare & Medicaid Services, the Office for Civil Rights, and any other governmental agency or body having jurisdiction over the Company or any of its properties, and has not engaged in any activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other local, state or federal healthcare program, except for such noncompliance that would not, individually or in the aggregate, reasonably be expected to biopharmaceutical productshave a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Foodshall mean, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.)as applicable, the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder pertaining to biopharmaceutical products; (ii) to the extent applicable to pre-commercial biopharmaceutical products, all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the federal Anti-Kickback kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the Civil Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the criminal false statements law False Claims Act (42 U.S.C. Section § 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the applicable criminal laws relating to health care fraud criminal provisions under and abuse, the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) exclusion laws (42 U.S.C. Section 1320d et seq.§ 1320a-7), the civil monetary penalties law (42 U.S.C. Section § 1320a-7a), the health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §§ 1320d et seq.) (“HIPAA”), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. Section 1320a-7§ 1320a-7a), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section §§ 17921 et seq.); , the Federal Food, Drug, and Cosmetic Act (iv) all other local21 U.S.C. §§ 301 et seq.), statethe Patient Protection and Affordable Care Act of 2010 (Pub. Law 111-148), federalas amended by the Health Care and Education Reconciliation Act of 2010 (Pub. Law 111-152), national, supranational and foreign laws, relating the regulations promulgated pursuant to the regulation aforementioned statutes. None of the Company or its subsidiaries; and (v) the directives and regulations promulgated Subsidiaries is a party to or has any ongoing reporting obligations pursuant to such statutes and any state corporate integrity agreement, deferred prosecution agreement, monitoring agreement, consent decree, settlement order, plan of correction or non-U.S. counterpart thereofsimilar agreement imposed by any governmental authority. Neither None of the Company nor any of or its subsidiaries Subsidiaries has received any written notification, correspondence or any other written communication, including, without limitation, any Form FDA 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any similar regulatory authority, or any notification of any pending or, to the Company’s knowledge, threatened claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action action, from any court governmental authority of alleging material non-compliance by, or arbitrator material liability of, the Company or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by Subsidiaries under any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor any of their respective employees, officers, directors, or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.