Common use of Compliance with Health Care Laws Clause in Contracts

Compliance with Health Care Laws. The Company has operated and currently is in compliance with all applicable health care laws, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, (i) the Federal, Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) all applicable federal, state, local and all applicable foreign healthcare related fraud and abuse laws, including, without limitation, the federal Anti-kickback Statute (42 U.S.C. § 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the criminal False Claims Law (42 U.S.C. § 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 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. § 1320a-7a); (iii) HIPAA, as amended by the Health Information Technology for Economic Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) the regulations promulgated pursuant to such laws; and (v) any other similar local, state, federal, or foreign laws (collectively, the “Health Care Laws”). Neither the Company, nor to the Company’s knowledge, any of its 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, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company is not a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreement, monitoring agreement, consent decree, settlement order, plan of correction or similar agreement imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its employees, officers or directors, 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 has operated and currently is its subsidiaries are, and at all times have been, in compliance with all applicable health care lawsHealth Care Laws, rules and regulations (except where such failure to operate or non-compliance would notas could not be expected, singly individually or in the aggregate, result in to have a Material Adverse Effect). For purposes of this Agreement, including, without limitation, “Health Care Laws” means: (i) the Federal, Federal Food, Drug Drug, and Cosmetic Act (21 U.S.C. §§ Section 301 et seq.) and the regulations promulgated thereunder and the Public Health Service Act (42 USC Section 201 et seq); (ii) all applicable federal, state, local and all applicable foreign healthcare related fraud and abuse health care laws, including, without limitation, the federal U.S. Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act Civil Monetary Penalties Law (42 U.S.C. § 1320a-7hSection 1320a-7a), the U.S. civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law (42 U.S.C. § 1320a-7b(a))all applicable federal, all state, local and foreign criminal laws relating to healthcare health care fraud and abuse, including but not limited to the U.S. False Statements Law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, and the healthcare 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. § Section 1320a-7), the statutes, regulations and the civil monetary penalties law (42 U.S.C. § 1320a-7a)directives of applicable 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 the regulations promulgated thereunder, including the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), the Security Standards for the Protection of Electronic Protected Health Information (the “Security Rule”), and the Standards for Electronic Transactions and Code Sets, and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the Patient Protection and Affordable Care Act of 2010 (Public Law 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Public Law 111-152), and the regulations promulgated pursuant to such lawsthereunder; (v) the U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); (vi) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vvii) any all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws (collectively, the “Health Care Laws”)its subsidiaries. Neither the Company, Company nor to the Company’s knowledge, any of its officers, directors, employees or agents 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 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, andLaws nor, to the Company’s knowledge, no is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company is and its subsidiaries have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, 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). Neither the Company nor its subsidiaries are a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, its subsidiaries nor to the Company’s knowledge, any of its their respective employees, officers or directors, directors 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 suspension, or exclusion.

Compliance with Health Care Laws. The Company has operated and currently is its subsidiaries are, and at all times have been, in compliance with all applicable health care lawsHealth Care Laws in all material respects. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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 exclusion laws Sxxxx Law (42 U.S.C. § 1320a-7Section 1395nn), and 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 regulations promulgated pursuant to such lawsPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; and (v) any licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; (vi) all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws its subsidiaries; and (collectively, vii) the “Health Care Laws”)directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers or 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 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 is, and at all times has operated and currently is been, in compliance with all applicable health care lawsHealth Care Laws, rules and regulations (except where such the failure to operate or non-compliance do so would not, singly or in the aggregate, not reasonably be expected to result in a Material Adverse Effect)Change. For purposes of this Agreement, including, without limitation, “Health Care Laws” means: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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 exclusion laws Xxxxx Law (42 U.S.C. § 1320a-7Section 1395nn), and 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) HIPAAthe Patient Protection and Affordable Care Act of 2010, as amended by the Health Information Technology for Economic Clinical Health Care and Education Reconciliation Act (42 U.S.C. Section 17921 et seq.)of 2010; (iv) the regulations promulgated pursuant to such lawslicensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (v) any all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws its subsidiaries, and (collectively, vi) the “Health Care Laws”)directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, an of its subsidiaries nor to the Company’s knowledge, any of its their respective employees, officers or 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 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 has operated and currently is its subsidiaries are, and at all times have been, in compliance with all applicable health care lawsHealth Care Laws, rules and regulations (except where such failure to operate or non-be in compliance would notnot reasonably be expected to, singly individually or in the aggregate, result in a Material Adverse Effect). For purposes of this Agreement, including, without limitation, “Health Care Laws” means: (i) the Federal, Federal Food, Drug Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.)and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign healthcare health care related fraud and abuse laws, including, without limitation, the federal U.S. Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act Anti-Inducement Law (42 U.S.C. § 1320a-7h1320a-7a(a)(5)), the civil U.S. Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law (42 U.S.C. § 1320a-7b(a))all applicable federal, state, local and all foreign criminal laws relating to healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the healthcare 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)laws, the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the civil monetary penalties law (42 U.S.C. § 1320a-7a)regulations promulgated pursuant to such statutes; (iii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated 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 or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, the regulations promulgated pursuant to such lawsthereunder; (v) the U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); (vi) quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vvii) any all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws (collectively, the “Health Care Laws”)any of its subsidiaries. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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 material violation of any Health Care Laws, andLaws nor, to the Company’s knowledge, no is any 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers or directors, directors 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 suspension, or exclusion.

Compliance with Health Care Laws. The Company is and at all times has operated and currently is been, in compliance with all applicable health care lawsHealth Care Laws, rules and regulations (except where such failure to operate or non-be in compliance would not, singly or in the aggregate, result in not be expected reasonably to have a Material Adverse Effect). For purposes of this Agreement, including, without limitation, “Health Care Laws” means: (i) the Federal, Federal Food, Drug Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.)and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign healthcare health care related fraud and abuse laws, including, without limitation, the federal U.S. Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act Anti-Inducement Law (42 U.S.C. § 1320a-7h1320a-7a(a)(5)), the civil U.S. Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), all criminal laws relating to healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the healthcare 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)laws, the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the civil monetary penalties law (42 U.S.C. § 1320a-7a)regulations promulgated pursuant to such statutes; (iii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated 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 or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, the regulations promulgated pursuant to such lawsthereunder; (v) the U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); and (vvi) any and all other similar local, state, federal, or foreign applicable health care laws (collectively, the “Health Care Laws”). Neither the Company, nor to the Company’s knowledge, any of its 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 programand regulations. 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 material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company is not a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, Company nor to the Company’s knowledge, any of its employees, officers or directors, directors 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 suspension, or exclusion.

Compliance with Health Care Laws. The Company has operated and, to the Company’s knowledge, its directors, employees and currently is agents (while acting in such capacity) are and at all times have been in compliance with with, all applicable health care lawslaws applicable to the Company, rules and regulations (or any of its products or activities, except where any such failure to operate or non-compliance noncompliance would not, singly individually or in the aggregate, result in a Material Adverse Effect), including, without limitation, (i) the Federal, Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) all applicable federal, state, local and all applicable foreign healthcare related fraud and abuse laws, including, without limitationbut not limited to, the federal Anti-kickback Kickback Statute (42 U.S.C. § 1320a-7b(bSection 1320a7b(b)), the U.S. Physician Payments Sunshine Act Civil Monetary Penalties Law (42 U.S.C. § 1320a-7hSection 1320a7a), the civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law (42 U.S.C. § 1320a-7b(aSection 1320a7b(a)), all criminal laws relating to healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 286, 287, 1035, 1347 and 1349, the healthcare fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), and the civil monetary penalties law (42 U.S.C. § 1320a-7a); (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) 42 U.S.C. Section 1320a7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and applicable laws governing government funded or sponsored healthcare programs, the regulations promulgated pursuant to such laws; , and (v) any other similar local, state, federalfederal or foreign law, accreditation standards, regulation, memorandum, opinion letter, or foreign laws other issuance which imposes 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, or medical devices (collectively, the “Health Care Laws”). Neither the Company, nor to the Company’s knowledge, any of its 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 any written notice notification, correspondence or any other correspondence written or oral communication, including notification of any pending or threatened 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, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, 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 in any material respect by, or material liability of, the Company under any Health Care Laws. To the Company’s knowledge, there are no facts or circumstances that would reasonably be expected to give rise to material liability of the Company under any Health Care Laws. The statements with respect to Health Care Laws and the Company’s compliance therewith included in the Preliminary Prospectus, in the Time of Sale Disclosure Package and in the Prospectus fairly summarize the matters therein described. The Company has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by applicable Health Care Laws, and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission) in any material respect. None of the Company, its subsidiaries or any of their respective directors, officers, employees or, to the Company’s knowledge, agents is threatenedor has, during the past three (3) years, engaged in activities which are cause for, or has been convicted of any federal civil or criminal activity or engaged in any conduct that are cause for false claims liability or civil penalties or would result in mandatory or permissive debarment, suspension or exclusion from any federal or state government health care program, including Medicare and Medicaid, or, to the knowledge of the Company, is subject to an inquiry, investigation, proceeding, or other similar action by any governmental authority that could reasonably be expected to result in debarment, suspension, or exclusion. The Company is not a party to and does not have or has any ongoing reporting or disclosure obligations pursuant to to, any corporate integrity agreementagreements, deferred or non- prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan plans of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, Company nor to the Company’s knowledge, any of its employees, officers or directors, directors has been excluded, suspended or debarred from participation in any U.S. state or federal health care program program, human research study, clinical trial 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 exclusionregistry.

Compliance with Health Care Laws. The Without limiting the generality of subsection (39) above, neither the Company has operated and currently nor any of its licensees (if any), nor any of its business operations, is in compliance with all applicable health care lawsviolation of any Health Care Laws, rules and regulations (except where such the failure to operate or non-be in compliance would not, singly individually or in the aggregate, result in a Material Adverse Effect). For purposes of this Agreement, including, without limitation, “Health Care Laws” means: (i) the Federal, U.S. Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.)and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign healthcare health care related fraud and abuse laws, including, without limitation, the federal U.S. Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act Sxxxx Law (42 U.S.C. § 1320a-7hSection 1395nn), the civil U.S. 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 Claims Law United States Code and the regulations promulgated pursuant to such statutes; (42 U.S.C. § 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 healthcare 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.), the exclusion laws (42 U.S.C. § 1320a-7), and the civil monetary penalties regulations promulgated thereunder and any non-U.S. counterpart thereof or other law (42 U.S.C. § 1320a-7a); (iii) HIPAA, as amended by or regulation the Health Information Technology for Economic Clinical Health Act (42 U.S.C. Section 17921 et seq.)purpose of which is to protect the privacy of individuals; (iv) the U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated pursuant to such lawsthereunder; (vi) the U.S. Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and the regulations promulgated thereunder; (vii) the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (viii) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (vix) any and all other similar localapplicable health care laws, stateregulations, federalmanual provisions, or foreign laws (collectively, the “Health Care Laws”). Neither the Company, nor to the Company’s knowledge, any of its 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, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company is not a party to policies and does not have any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreement, monitoring agreement, consent decree, settlement order, plan of correction or similar agreement imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its employees, officers or directors, has been excluded, suspended or debarred from participation administrative guidance 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 exclusionjurisdiction.

Compliance with Health Care Laws. The Company has operated and currently is its subsidiaries are, and at all times have been, in material compliance with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) , the Xxxxx Law (42 U.S.C. Section 1320d et seq.1395nn), 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), 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 regulations promulgated pursuant to such lawsPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vvi) any all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws its subsidiaries, and (collectively, vii) the “Health Care Laws”)directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof to which the Company is subject. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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 material violation of any Health Care Laws, andLaws nor, to the Company’s knowledge, no is any 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its subsidiaries, nor any of their respective employees, officers or officers, directors, or to the knowledge of the Company, 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 suspension, or exclusion.

Compliance with Health Care Laws. The Company has operated and currently is its subsidiaries are, and at all times have been, in compliance in all respects with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (i) the Federal, Federal Food, Drug Drug, and Cosmetic Act (21 U.S.C. §§ Section 301 et seq.)) and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 286, 287, 1035, 1347, 1349 and the healthcare 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), 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 regulations promulgated pursuant to such lawsPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vvi) any all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws its subsidiaries, and (collectivelyvii) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any subsidiary has received any FDA Form-483, the “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 material non-compliance with any applicable Health Care Laws or Permits required by any such Health Care Laws”). Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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 product, operation, or activity is in violation of any Health Care Laws, andLaws nor, to the Company’s knowledge, no is any 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers or 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 subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension suspension, or exclusion. Any certificate signed by any officer of the Company or any of its subsidiaries and delivered to any Underwriter or to counsel for the Underwriters in connection with the offering, or the purchase and sale, of the Offered Shares shall be deemed a representation and warranty by the Company to each Underwriter as to the matters covered thereby. The Company has a reasonable basis for making each of the representations set forth in this Section 1. The Company acknowledges that the Underwriters and, for purposes of the opinions to be delivered pursuant to Section 6 hereof, counsel to the Company and counsel to the Underwriters, will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.

Compliance with Health Care Laws. The Company has operated and currently is its subsidiaries are, and at all times have been, in compliance in all material respects with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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 Sxxxx Law (42 U.S.C. § 1320a-7Section 1395nn), and 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 regulations promulgated pursuant to such lawsPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vvi) any all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws its subsidiaries, and (collectively, vii) the “Health Care Laws”)directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, any of its subsidiaries nor any of their respective officers or directors, or, to the Company’s knowledge, any of its employees, officers their respective employees or directors, 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 suspension, or exclusion.

Compliance with Health Care Laws. The Company has operated and currently is each Subsidiary are, and at all times have been, in compliance with all Health Care Laws in all material respects. For purposes of this Agreement, “Health Care Laws” means, to the extent applicable health care laws, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, Company’s operations: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare health care fraud criminal provisions under HIPAA, the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Xxxxx Law (42 U.S.C. Section 1320d et seq.1395nn), 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), the Physician Payments Sunshine Act (42 U.S.C. Section 1320a-7h); (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 regulations promulgated pursuant to such laws; and (v) any all other similar comparable local, state, federal, national, supranational and foreign health care laws, relating to the regulation of the Company or foreign laws the Subsidiaries, and (collectively, v) the “Health Care Laws”)directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 Subsidiary 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 Governmental Authority or third party alleging that any product product, Company operation or activity is in material violation of any Health Care Laws, andLaws nor, to the Company’s knowledge, no is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company and each Subsidiary 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 Subsidiary is not a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authorityGovernmental Authority related to any Health Care Laws. Additionally, neither the CompanyCompany nor any Subsidiary, nor any of their employees, officers, directors, or, to the Company’s knowledge, any of its employees, officers or directors, 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 suspension, or exclusion.

Compliance with Health Care Laws. The Except to the extent any noncompliance would have a Material Adverse Effect, the Company has operated and currently is its subsidiaries are, and at all times have been, in compliance with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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 exclusion laws Xxxxx Law (42 U.S.C. § 1320a-7Section 1395nn), and 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 regulations promulgated pursuant to such lawsPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vvi) any all other similar applicable local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws its subsidiaries, and (collectively, vii) the “Health Care Laws”)directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers or 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 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 has operated and currently is its subsidiaries are and at all times have been, in compliance with all applicable health care lawsHealth Care Laws, rules and regulations (except where such failure to operate or non-be in compliance would not, singly or in the aggregate, result in not be expected reasonably to have a Material Adverse Effect)Change. For purposes of this Agreement, including, without limitation, “Health Care Laws” means: (i) the Federal, Federal Food, Drug Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.)and the Public Health Service Act and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign healthcare health care related fraud and abuse laws, including, without limitation, the federal U.S. Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), 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 Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), all criminal laws relating to healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the healthcare 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), the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the civil monetary penalties law (42 U.S.C. § 1320a-7a)regulations promulgated pursuant to such statutes; (iii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated 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 or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, the regulations promulgated pursuant to such lawsthereunder; (v) the U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); and (vvi) any and all other similar local, state, federal, or foreign applicable health care laws (collectively, the “Health Care Laws”). Neither the Company, nor to the Company’s knowledge, any of its 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 programand regulations. The Company has and its subsidiaries have 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 material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company is and its subsidiaries are not a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or 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 employees, officers or directors, directors 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 suspension, or exclusion.

Compliance with Health Care Laws. The Company has operated and currently is in compliance with all applicable health care laws, rules and regulations (except where such failure Except as would not reasonably be expected to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect): (A) the Company and each of its Subsidiaries and, to the Company’s knowledge, their respective directors, employees and agents (while acting in such capacity) (i) are and at all times have been in compliance with, all Health Care Laws applicable to the Company, or any of its devices or activities, including, without limitationbut not limited to, (i) the Federalrules and regulations of the FDA, Foodthe HHS, Drug the CMS, the U.S. Department of Justice and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) all applicable any other state, federal, statenational, regional, provincial, local or foreign or other governmental authority or instrumentality, legislative body, court, administrative agency, regulatory body or authority, commission or instrumentality, including any supra-national or multinational authority having governmental or quasi-governmental powers, or any other industry self-regulatory authority having jurisdiction over the Company or any of its products or activities (“Governmental Authority”), including but not limited to European Union and all applicable foreign healthcare related fraud and abuse lawsEuropean Union Member State’s rules governing medical devices, includingincluding but not limited to Directive 93/42 on Medical Devices, without limitationRegulation 2017/745 on Medical Devices, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act Anti-Inducement Law (42 U.S.C. § 1320a-7hSection 1320a-7a(a)(5)), the civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal administrative 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 the Sxxxx law (42 U.S.C. Sections 286 and 287Section 1395nn), the 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. § 1320a-7a); (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) 42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Controlled Substances Act (21 U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated pursuant to such laws; , and (v) any other similar local, applicable state, federalfederal or foreign national or supranational law, accreditation standards, regulation, directive, memorandum, opinion letter, or foreign laws other issuance which imposes requirements on manufacturing, development, non-clinical, clinical testing, production, analysis, certification, labeling, advertising, marketing, promotion, interactions with healthcare professionals, healthcare organizations or patient organizations, distribution, importation, exportation, use, handling, quality sale, 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 devices or services (collectively, the “Health Care Laws”). Neither the Company, nor to the Company’s knowledge, any of its officers, directors, employees or agents and (ii) have 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 state local, state, federal or federal foreign equivalent healthcare program. The ; (B) the Company has not received any notification, correspondence or any other written notice or other correspondence oral communication, including notification of any pending or threatened 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, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The from any Governmental Authority, including, without limitation, the FDA, the national competent authorities of European Union Member States, European Union Notified Bodies, 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 similar agencies or authorities of potential or actual non-compliance by, or liability of, the Company or any subsidiary under any Health Care Laws; (C) the Company is not a party in compliance with all applicable Health Care Laws applicable to the maintenance, compilation and does not have any ongoing reporting obligations pursuant to any corporate integrity agreementfiling of reports and registration requirements; (D) the Company has filed, deferred prosecution agreementobtained, monitoring agreementmaintained, consent decreeor submitted all reports, settlement orderdocuments, plan of correction forms, notices, applications, records, claims, submissions, and supplements or similar agreement imposed amendments as required by any governmental Applicable Health Care Laws or regulatory authority. AdditionallyPermits, neither and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct on the date filed (or were corrected or supplemented by a subsequent submission) and remain complete and correct in all material respects; and (E) all of the Company’s products are developed, nor to investigated, manufactured, prepared, packaged, tested, labeled and distributed in compliance in all material respects with the applicable Health Care Laws or any comparable Law. To the Company’s knowledge, any of its employees, officers or directors, has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or, components supplied to the knowledge Company by third parties based on specifications provided by the Company are manufactured by such third parties in accordance with such specifications in all material respects. All of the Company’s products, is subject to a governmental inquiryincluding all components, investigationpackaging, proceedinglabeling and promotional materials or oral representations for such products, comply in all material respects with applicable Health Care Laws. To the Company’s knowledge, there are no facts or other similar action circumstances that could would reasonably be expected to result give rise to material liability of the Company or any of its Subsidiaries under any Health Care Laws. The statements with respect to Health Care Laws and the Company’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 has operated and currently is its subsidiaries are, and at all times have been, in compliance with all applicable health care lawsHealth Care Laws, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in not be reasonably expected to have a Material Adverse Effect). For purposes of this Agreement, including, without limitation, “Health Care Laws” means: (i) the Federal, Federal Food, Drug Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.)and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal U.S. Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Statements 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 286, 287, 1035, 1347, and 1349 the healthcare 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.)HIPAA , the exclusion laws (42 U.S.C. § 1320a-7), and the civil monetary penalties law (42 U.S.C. § Section 1320a-7a); (iii) HIPAA, as amended by the Health Information Technology for Economic Clinical Health Act exclusions law (42 U.S.C. Section 17921 et seq.1320a-7); , the Physician Payments Sunshine Act (iv) 42 X.X.X Xxxxxxx 0000-0x), and the regulations promulgated pursuant to such lawslaws governing U.S. government funded or sponsored healthcare programs; and (viii) any all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws its subsidiaries, and (collectively, iv) the “Health Care Laws”)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, any of their respective officers, or directors, nor, to the knowledge of the Company, any of the Company’s knowledge, or any of its officers, directors, subsidiaries’ 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 liability under a Health Care Law. Neither the Company nor any other state or federal healthcare program. The Company of its subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any 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), except where the failure to file, maintain or submit would not, individually or in the aggregate, have a Material Adverse Effect). 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, Company or any of its subsidiaries nor any of their respective employees, officers or 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 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 has operated and currently is its subsidiaries are, and at all times have been, in compliance with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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), 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 regulations promulgated pursuant to such lawslicensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (v) any all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws its subsidiaries; and (collectively, vi) the “Health Care Laws”)directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers or 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 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 has operated and currently is its subsidiaries are, and at all times have been, in compliance in all material respects with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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 exclusion laws Xxxxx Law (42 U.S.C. § 1320a-7Section 1395nn), and 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) HIPAAthe Patient Protection and Affordable Care Act of 2010, as amended by the Health Information Technology for Economic Clinical Health Care and Education Reconciliation Act (42 U.S.C. Section 17921 et seq.)of 2010; (iv) the regulations promulgated pursuant to such licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws; and (v) the directives and regulations promulgated pursuant to such statutes and any other similar local, state, federal, state or foreign laws (collectively, the “Health Care Laws”)non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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 material violation of any Health Care Laws, andLaws nor, to the knowledge of the Company’s knowledge, no is any 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the CompanyCompany nor any of its subsidiaries nor, nor to the knowledge of the Company’s knowledge, any of its their respective employees, officers or 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 subject to a governmental inquiry, investigation, proceeding, or other similar action that could would reasonably be expected to result in debarment, suspension suspension, or exclusion. 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 matters set forth therein. The Company acknowledges that Cowen and, for purposes of the opinions to be delivered pursuant to Section 7 hereof, counsel to the Company and counsel to Cowen, will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.

Compliance with Health Care Laws. The Company has operated and currently is its subsidiaries are, and at all times have been, in compliance in all material respects with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (i) the Federal, Federal Food, Drug Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.); and the regulations promulgated thereunder, (ii) all applicable federal, state, local and all applicable foreign healthcare health care related fraud and abuse laws, including, without limitation, the federal U.S. Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act civil monetary penalties law (42 U.S.C. § 1320a-7h1320a-7a), the civil U.S. Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the U.S. criminal False Claims Law false statements law (42 U.S.C. § 1320a-7b(a)), all applicable federal, state, local and all foreign criminal laws relating to healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the healthcare 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 U.S. exclusion laws law (42 U.S.C. § 1320a-7), the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the civil monetary penalties law (42 U.S.C. § 1320a-7a); regulations promulgated pursuant to such statutes, (iii) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated 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 or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers, (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 pursuant to such lawsthereunder; and (v) any 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 similar local, state, federal, or national, supranational and foreign laws (collectively, the “Health Care Laws”). Neither the Company, nor applicable to the Company’s knowledge, any of Company and its 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 programsubsidiaries. The Company has and its subsidiaries have 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, and, to the Company’s knowledge, no Laws nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company is 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). The Company and its subsidiaries are not a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the CompanyCompany and its subsidiaries nor, nor to the Company’s best of its knowledge, any of its their employees, officers or directors, directors 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, or 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 has operated and currently is its subsidiaries are, and at all times have been, in material compliance with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (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; (ii) all applicable U.S. federal, state, local and all applicable foreign healthcare related non-U.S. health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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), 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 non-U.S. laws relating to the regulation of the Company or its subsidiaries, and (vii) the directives and regulations promulgated pursuant to such laws; statutes, and (v) any other similar localstate or non-U.S. counterpart thereof. Except as disclosed in the Registration Statement and the Prospectus, state, federal, or foreign laws (collectively, neither the “Health Care Laws”). Neither the Company, Company nor to the Company’s knowledge, any of its officerssubsidiaries has received written notice of any FDA Form 483, directorsnotice of adverse finding, employees warning letter or agents have engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaiduntitled letter, or any other state pending or federal healthcare program. The Company has not received written notice or other correspondence of any completed claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action (“Action”) from the FDA or any court or arbitrator or other governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws, andLaws nor, to the Company’s knowledge, no is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatenedthreatened by the FDA or any court or arbitrator or other governmental or regulatory authority or third party. 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, except as disclosed in the Registration Statement and the Prospectus, neither the Company, nor to the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers or officers, directors, or, to the knowledge of the Company, their respective 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 suspension, or exclusion.

Compliance with Health Care Laws. The Company has operated and currently is its subsidiaries are, and at all times have been, in compliance in all material respects with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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 Xxxxx Law (42 U.S.C. § 1320a-7Section 1395nn), and 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 regulations promulgated pursuant to such lawsPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vvi) any all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws its subsidiaries in connection with health care matters, and (collectively, vii) the “Health Care Laws”)directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries has not received written notice or other correspondence of any material 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, andLaws nor, to the Company’s knowledge, no is any 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authorityauthority that could result in a Material Adverse Change. Additionally, neither the Company, any of its subsidiaries nor any of their respective officers or directors, or, to the Company’s knowledge, any of its employees, officers their respective employees or directors, 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 suspension, or exclusionexclusion that could result in a Material Adverse Change.

Compliance with Health Care Laws. The Company has operated and currently is its subsidiaries are, and at all times have been, in material compliance with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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 exclusion laws Xxxxx Law (42 U.S.C. § 1320a-7Section 1395nn), and the civil monetary penalties law (42 U.S.C. § 1320a-7aSection 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) HIPAAthe Patient Protection and Affordable Care Act of 2010, as amended by the Health Information Technology for Economic Clinical Health Care and Education Reconciliation Act (42 U.S.C. Section 17921 et seq.)of 2010; (iv) the regulations promulgated pursuant to such lawslicensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (v) any all other similar local, state, federal, national, supranational and foreign health care laws relating to the regulation of the Company or foreign laws its subsidiaries, in each case excluding Privacy Laws; and (collectively, vi) the “Health Care Laws”)directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any 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, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, any of its subsidiaries nor any of their respective employees, officers, directors, or, to the Company’s knowledge, any of its employees, officers or directors, 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 would reasonably be expected to result in debarment, suspension suspension, or exclusion.

Compliance with Health Care Laws. The Except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change, the Company has operated and currently is its subsidiaries are, and at all times have been, in compliance with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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 Xxxxx Law (42 U.S.C. § 1320a-7Section 1395nn), and 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 regulations promulgated pursuant to such lawsPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; and (v) any licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; (vi) all other similar local, state, federal, or national, supranational and foreign laws (collectivelylaws, the “Health Care Laws”). Neither the Company, nor relating to the Company’s knowledgeregulation of the Company or its subsidiaries; and (vii) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change, neither the Company nor any of its 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 subsidiaries 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, and, to the Company’s knowledge, no Laws nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change, 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). Except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change, 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. AdditionallyExcept as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change, neither the Company, nor to the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers or 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, or 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. 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 has operated and currently is its subsidiaries are, and at all times have been, in compliance with all applicable health care lawsHealth Care Laws in all material respects. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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 exclusion laws Sxxxx Law (42 U.S.C. § 1320a-7Section 1395nn), and 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 regulations promulgated pursuant to such lawsPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vvi) any all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws its subsidiaries, and (collectively, vii) the “Health Care Laws”)directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers or 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 subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension 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 has operated and currently is its subsidiaries are, and at all times have been, in material compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means, to the extent applicable health care laws, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, Company,: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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 Xxxxx Law (42 U.S.C. § 1320a-7Section 1395nn), and 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 regulations promulgated pursuant to such lawsPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vvi) any all other similar local, state, federal, national, supranational and foreign health care laws, relating to the regulation of the Company or foreign laws its subsidiaries, and (collectively, vii) the “Health Care Laws”)regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is currently 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 to the extent 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 in all material respects on the date filed (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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers or 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 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 has operated and currently is in compliance with all applicable health care laws, rules and regulations (except where such failure to operate or non-compliance Except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect), includingthe Company and its subsidiaries are, without limitationand at all times have been, in compliance with all applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means: (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; (ii) all applicable U.S. federal, state, local and all applicable foreign healthcare related non-U.S. health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements law (42 U.S.C. § Section 1320a-7b(a)), all criminal laws relating to healthcare fraud and abusethe civil monetary penalties law (42 U.S.C. Section 1320a-7a), including but not limited to 18 U.S.C. Sections 286 and 287, the healthcare 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), 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 Clinical Health Act (42 U.S.C. Section 17921 et seq.)HITECH Act; (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 non-U.S. health care laws relating to the regulation of the Company or its subsidiaries, and (vii) the regulations promulgated pursuant to such laws; statutes, and (v) any other similar local, state, federal, state or foreign laws (collectively, the “Health Care Laws”)non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its officerssubsidiaries has received any FDA Form 483, directorsnotice of adverse finding, employees warning letter, untitled letter 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 material violation of any Health Care Laws, andLaws nor, to the Company’s knowledge, no is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened or pending. Neither the Company nor any of its subsidiaries is threatened. The Company is not a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither none of the Company, any of its subsidiaries nor any of their respective employees, officers, directors or, to the Company’s knowledge, any of its employees, officers or directors, their respective agents has been excluded, suspended suspended, debarred or debarred disqualified 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 disqualification, suspension, or exclusion.

Compliance with Health Care Laws. The Company has operated and currently is its subsidiaries are and have been in compliance with all applicable health care lawsHealth Care Laws (as hereinafter defined), rules and regulations (except where such failure to operate or instances of non-compliance would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect). For purposes of this Agreement, “Health Care Laws” means all health care laws applicable to the Company, including, without limitation, (i) but not limited to: the Federal, Federal Food, Drug Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) all applicable federal, state, local and all applicable foreign healthcare related fraud and abuse laws, including, without limitationAct, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payments Payment Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), all criminal laws relating to healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the healthcare 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. § 1320a-7a); (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 or federal health care laws and the regulations promulgated pursuant to such laws; and (v) any other similar local, stateincluding, federal, or foreign laws (collectivelywithout limitation, the “Health Care Laws”). Neither the CompanyFDA’s current good manufacturing practice regulations at 21 CFR Part 820, nor 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 knowledgeproducts, any of each as amended from time to time. The Company and its officers, directors, employees or agents subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, penalties or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal healthcare 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. The Neither the Company has not nor any of its subsidiaries have 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 a material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Neither the Company is not nor any of its subsidiaries are a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreementagreements, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan plans of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the CompanyCompany nor any of its subsidiaries, nor to the knowledge of the Company’s knowledge, any of its employees, officers or directors, directors has been excluded, suspended or debarred from participation in any U.S. state or 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 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 has operated and currently is its subsidiaries are, and at all times have been, in compliance with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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 Xxxxx Law (42 U.S.C. § 1320a-7U.S.C Section 1395nn), and 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 regulations promulgated pursuant to such lawsPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; and (v) any licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; (vi) all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws its subsidiaries; and (collectively, vii) the “Health Care Laws”)directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers or 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 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 has operated and currently is its subsidiaries are, and at all times have been, in material compliance with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (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 16 promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) , the Sxxxx Law (42 U.S.C. Section 1320d et seq.1395nn), 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), 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 regulations promulgated pursuant to such lawsPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vvi) any all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws its subsidiaries, and (collectively, vii) the “Health Care Laws”)directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof to which the Company is subject. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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 material violation of any Health Care Laws, andLaws nor, to the Company’s knowledge, no is any 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its subsidiaries, nor any of their respective employees, officers or officers, directors, or to the knowledge of the Company, 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 suspension, or exclusion.

Compliance with Health Care Laws. The Company has operated and currently is its subsidiaries are, and at all times have been, in compliance with all applicable health care lawsHealth Care Laws, rules and regulations (except where such failure to operate or non-compliance do so would not, singly or in the aggregate, result in not reasonably be expected to have a Material Adverse Effect). For purposes of this Agreement, including, without limitation, “Health Care Laws” means: (i) the Federal, Federal Food, Drug Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign healthcare health care related fraud and abuse laws, including, without limitation, the federal U.S. Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act federal criminal false claims law (42 U.S.C. § 1320a-7h1320a-7b), the federal 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 criminal False Claims Xxxxx Law (42 U.S.C. § 1320a-7b(a1395nn), the exclusion laws (42 U.S.C. § 1320a-7), all applicable federal, state, local and all foreign criminal laws relating to healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the healthcare health care fraud criminal provisions under HIPAA, (ii) the U.S. Health Insurance Portability statutes, regulations and Accountability Act directives of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7)applicable government funded or sponsored healthcare programs, and the civil monetary penalties law (42 U.S.C. § 1320a-7a)regulations promulgated pursuant to such statutes; (iii) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, as amended by the HITECH Act, and the regulations promulgated thereunder and any state counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the Patient Protection and Affordable Care Act of 2010 (Public Law 111-148), as amended by the Health Information Technology for Economic Clinical Health Care and Education Reconciliation Act of 2010 (Public Law 111-152), the regulations promulgated thereunder; (v) the U.S. Controlled Substances Act (42 21 U.S.C. Section 17921 801 et seq.); (ivvi) quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; (vii) Medicare, Title XVIII of the regulations promulgated pursuant to such lawsSocial Security Act, Medicaid, Title XIX of the Social Security Act; and (vviii) any all other similar local, state, federal, or national, supranational and foreign laws (collectivelylaws, the “Health Care Laws”). Neither the Company, nor relating to the Company’s knowledgeregulation of the Company or its subsidiary. Except as otherwise disclosed in the documents incorporated by reference in the Time of Sale Information and the Offering Memorandum, neither the Company nor any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any 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 required and 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 not a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreementagreements, deferred prosecution agreementplans of correction, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers or directors, directors 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 suspension, or exclusion.

Compliance with Health Care Laws. The Company has operated and currently is its subsidiaries are, and at all times have been, in material compliance with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (i) the Federal, Federal Food, Drug 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.) as amended and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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 Xxxxx Law (42 U.S.C. § 1320a-7Section 1395nn), and 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 regulations promulgated pursuant to such lawsPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; and (v) any licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; (vi) all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws its subsidiaries, and (collectively, vii) the “Health Care Laws”)directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers or 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 subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension 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 has operated and currently is its subsidiaries are, and at all times have been, in material compliance with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (i) the Federal, Federal Food, Drug Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.)Act, Public Health Service Act, and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign healthcare related fraud and abuse health care laws, including, without limitation, the federal U.S. Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), 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.), U.S. Physician Payments Sunshine Act (42 U.S.C. § Section 1320a-7h), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.)all applicable federal, the criminal False Claims Law (42 U.S.C. § 1320a-7b(a))state, local and all foreign criminal laws relating to healthcare health care fraud and abuse, including but not limited to the U.S. False Statements Law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, and the healthcare 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-7Section 1320-7), the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iii) the Standards for Privacy of Individually Identifiable Health Information, 45 C.F.R. parts 160 and 164 (subparts A and E) (the “Privacy Rule”), the Security Standards, 45 C.F.R. parts 160 and 164 (subparts A and C), the Breach Notification Rule, 45 C.F.R. part 164 (subpart D), and the civil monetary penalties law (42 U.S.C. § 1320a-7a); (iii) Standards for Electronic Transactions and Code Sets, 45 C.F.R. part 162, promulgated 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 or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, and the regulations promulgated pursuant to such lawsthereunder; and (vvi) any other similar locallicensure, quality, safety and accreditation requirements under applicable federal, state, federal, local or foreign laws (collectively, the “Health Care Laws”)or regulatory bodies. Neither the Company, Company nor to the Company’s knowledge, any of its officers, directors, employees or agents 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 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 material violation of any Health Care Laws, andLaws nor, to the Company’s knowledge, no is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company is and its subsidiaries have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, 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). Neither the Company nor its subsidiaries are a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreementagreements, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, its subsidiaries nor to the Company’s knowledge, any of its their respective employees, officers or directors, directors has been excluded, suspended or debarred from participation in any U.S. federal or state or federal health care program or human clinical research orresearch, nor, 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 suspension, or exclusion.

Compliance with Health Care Laws. The Company has operated and currently is its subsidiaries are, and at all times have been, in compliance in all material respects with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (i) the Federal, Federal Food, Drug Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.)and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal U.S. Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Statements 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 286 286, 287 and 287, 1349 the healthcare 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 exclusions law (42 U.S.C. Section 1320a-7), 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 regulations promulgated pursuant to such lawsPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vvi) any all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws its subsidiaries, and (collectively, vii) the “Health Care Laws”)directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company, nor to the Company’s knowledge, any of its subsidiaries, nor any of their respective 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 liability under a Health Care Law. Neither the Company nor any other state or federal healthcare program. The Company of its subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company Company, and to the Company’s knowledge, 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, any of its subsidiaries, nor, to the Company’s knowledge, any of their respective employees, officers, directors, or agents is not a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers or 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 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 has operated and currently is its subsidiaries have been and are in compliance in all material respects with all applicable health care lawsHealth Care Laws, rules and regulations (except where such failure to operate or non-be so in compliance would notnot reasonably be expected, singly individually or in the aggregate, result in to have a Material Adverse Effect). For purposes of this Agreement, including, without limitation, “Health Care Laws” means: (i) the Federal, Federal Food, Drug Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.)) and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign healthcare health care related fraud and abuse laws, including, without limitation, the federal U.S. Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Payment Sunshine Act (42 U.S.C. § 1320a-7h), the civil U.S. Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), all criminal laws relating to healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the healthcare 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. § 1320a-7a); (iii) , HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) , and the regulations promulgated pursuant to such lawsstatutes; (iii) Medicare (Title XVIII of the Social Security Act); (iv) Medicaid (Title XIX of the Social Security Act); (v) the Controlled Substances Act (21 U.S.C. §§ 801 et seq.) and the regulations promulgated thereunder; and (vvi) any and all other similar local, state, federal, or foreign applicable health care laws (collectively, the “Health Care Laws”)and regulations. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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 material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatenedthreatened against the Company or any of its subsidiaries. The Neither the Company nor any of its subsidiaries is not a party to and does not have or has any ongoing reporting obligations pursuant to any corporate integrity agreementagreements, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan plans of correction or similar agreement agreements with or imposed by any Regulatory Agency or other governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers or directors, directors 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 suspension, or exclusion.

Compliance with Health Care Laws. The Company has operated and currently is its subsidiaries are, and at all times have been, in compliance with all Health Care Laws in all material respects and to the extent applicable health care lawsto the Company’s current business. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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 Xxxxx Law (42 U.S.C. § 1320a-7Section 1395nn), and 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 regulations promulgated pursuant to such lawsPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vvi) any all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws its subsidiaries, and (collectively, vii) the “Health Care Laws”)directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, any of its subsidiaries nor any of their respective employees, officers, directors, or, to the Company’s knowledge, any of its employees, officers or directors, 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, or 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 has operated and currently is its Subsidiaries are, and at all times have been, in compliance in all material respects with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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 Xxxxx Law (42 U.S.C. § 1320a-7Section 1395nn), and 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 regulations promulgated pursuant to such lawsPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vvi) any all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws its Subsidiaries, and (collectively, vii) the “Health Care Laws”)directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 Subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its Subsidiaries nor any of their respective employees, officers or 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 subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension 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(p) 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 has operated and currently is its subsidiaries are in compliance with all applicable health care lawsHealth Care Laws, rules and regulations (except where such failure for any noncompliance that would not reasonably be expected to operate or non-compliance would not, singly or in the aggregate, result in have a Material Adverse Effect)Change. For purposes of this Agreement, including, without limitation, “Health Care Laws” means: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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 Xxxxx Law (42 U.S.C. § 1320a-7Section 1395nn), and 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 regulations promulgated pursuant to such lawsPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vvi) any all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws its subsidiaries, and (collectively, vii) the “Health Care Laws”)directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries has not received written notice or other correspondence of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other adverse action (“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, andLaws nor, to the Company’s knowledge, no is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other adverse action is threatened. The Company and its subsidiaries have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers or directors, directors 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 suspension, or exclusion. Any certificate signed by any officer or representative of the Company 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 has operated and currently is its subsidiaries are, and at all times have been, in compliance with all applicable health care lawsHealth Care Laws, rules and regulations (except where such failure to operate or non-be so in compliance would notnot reasonably be expected, singly individually or in the aggregate, result in to have a Material Adverse Effect). For purposes of this Agreement, including, without limitation, “Health Care Laws” means: (i) the Federal, 277712584 v11 Federal Food, Drug Drug, and Cosmetic Act (21 U.S.C. §§ Section 301 et seq.)) and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign healthcare health care related fraud and abuse laws, including, without limitation, the federal U.S. Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act Civil Monetary Penalties Laws (42 U.S.C. § 1320a-7hSection 1320a-7a), the civil U.S. Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law (42 U.S.C. § 1320a-7b(a))all applicable federal, all state, local and foreign criminal laws relating to healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the healthcare 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. § Section 1320a-7), the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the civil monetary penalties law regulations promulgated pursuant to such statutes; (iii) the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7aSection 1320-7h); (iiiiv) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the data privacy and security regulations promulgated thereunder; (ivv) the Patient Protection and Affordable Care Act of 2010 (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 thereunder; (vi) the U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); (vii) quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies, including, but not limited to, all laws applicable to such lawsownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company; and (vviii) any all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws (collectively, the “Health Care Laws”)its subsidiaries. Neither the Company, Company nor to the Company’s knowledge, any of its officers, directors, employees or agents 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 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, andLaws nor, to the Company’s knowledge, no is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Except as would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect, the Company is not 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 its subsidiaries are a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, its subsidiaries nor to the Company’s knowledge, any of its their respective employees, officers or directors, directors 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 would reasonably be expected to result in debarment, suspension suspension, or exclusion.

Compliance with Health Care Laws. The Company has operated and currently is its subsidiaries are in material compliance with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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 exclusion laws Xxxxx Law (42 U.S.C. § 1320a-7Section 1395nn), and 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; (iv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Information Technology for Economic Clinical Health Care and Education Reconciliation Act (42 U.S.C. Section 17921 et seq.)of 2010; (iv) the regulations promulgated pursuant to such laws; and (v) any licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; (vi) all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company, and (vii) the directives and regulations promulgated pursuant to such statutes and any state or foreign laws (collectively, the “Health Care Laws”)non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company has 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 subsidiaries is not a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its employees, officers or directors, 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 has operated and currently is in compliance with all applicable health care laws, rules and regulations (except where such failure to operate or non-compliance Except as would not, singly or in the aggregate, not result in a Material Adverse Effect)Change to the operations of the Company and its subsidiaries as a whole, includingthe Company and its subsidiaries are, without limitationand at all times have been, in compliance in all respects with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal, Federal Food, Drug Drug, and Cosmetic Act (21 U.S.C. §§ Section 301 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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 Xxxxx Law (42 U.S.C. § 1320a-7Section 1395nn), 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) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (v) the directives and regulations promulgated pursuant to such laws; statutes and (v) any other similar local, state, federal, state or foreign laws (collectively, the “Health Care Laws”)non-U.S. counterpart thereof. Neither the CompanyCompany or its subsidiaries, nor to the Company’s knowledge, or any of its respective officers, directors, employees or agents or, to the knowledge of the Company, agents, have engaged in activities which are, as applicable, cause for Federal civil or criminal false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, TRICARE, any federal health care program (as defined in 42 U.S.C. § 1320a-7b(f)) as described in 42 U.S.C. § 1320a-7(b)(8) or any other state or federal healthcare programprogram (collectively, the “Programs”). The Except as otherwise disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus or as would not result in a Material Adverse Change to the operations of the Company and its subsidiaries as a whole, neither the Company nor any of its subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened (“Action”). Except as would not result in a Material Adverse Change to the operations of the Company and its subsidiaries as a whole, 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, except as would not result in a Material Adverse Change to the operations of the Company and its subsidiaries as a whole, 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). Except as otherwise disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, neither the Company nor any of its subsidiaries is threatened. The Company is not a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor any of its subsidiaries nor, except as would not result in a Material Adverse Change to the Company’s knowledgeoperations of the Company and its subsidiaries as a whole, any of its their respective employees, officers or 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, except as otherwise disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, 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 has operated and currently is its subsidiaries are, and at all times have been, in compliance with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (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; (ii) all applicable U.S. federal, state, local and all applicable foreign healthcare related non-U.S. health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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 exclusion laws Sxxxx Law (42 U.S.C. § 1320a-7Section 1395nn), and 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; and (vi) all other local, state, U.S. federal, national, supranational and non-U.S. laws, relating to the regulation of the Company or its subsidiaries, and (vii) the directives and regulations promulgated pursuant to such laws; statutes and (v) any other similar local, state, federal, state or foreign laws (collectively, the “Health Care Laws”)non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers or 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 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 has operated and currently is in compliance with all applicable health care laws, rules and regulations (except where such failure to operate or non-compliance Except as would not, singly individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect)Change, includingthe Company and its subsidiaries are, without limitationand at all times within the past three years have been, in compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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), 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) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (v) the directives and regulations promulgated pursuant to such laws; statutes and (v) any other similar localstate or non-U.S. counterpart thereof. Within the past three years, state, federal, or foreign laws (collectively, neither the “Health Care Laws”). Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Within the past three 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 not a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither none of the Company, nor to the Company’s knowledge, any of its subsidiaries or any of their respective employees, officers or officers, directors, has or agents has, within the past three years, been or is currently 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 suspension, or exclusion.

Compliance with Health Care Laws. The Company has operated and currently is each of its subsidiaries are, and at all times have been, in material compliance with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (i) the Federal, Federal Food, Drug Drug, and Cosmetic Act; the Public Health Service Act (21 42 U.S.C. §§ 301 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign healthcare related fraud and abuse laws, including, without limitation, the federal U.S. Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Statements 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 286 286, 287, 1035, and 2871349, the 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 exclusions law (42 U.S.C. Section 1320a-7), the Sxxxx Law (42 U.S.C. § 1395nn), laws governing government funded or sponsored healthcare programs; the Clinical Laboratory Improvement Amendments of 1988; state clinical laboratory licensing laws; (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 regulations promulgated pursuant to such lawsPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; and (v) any licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; (vi) all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company and (vii) the directives and regulations promulgated pursuant to such statutes and any state or foreign laws (collectively, the “Health Care Laws”)non-U.S. counterpart thereof. Neither the CompanyCompany nor any of its subsidiaries or, nor to the Company’s knowledge, any of its their respective officers, directors, employees or agents agents, have engaged in activities which that are, as applicable, cause for false claims liabilityliability under a Health Care Law. Except as disclosed in the Registration Statement and the Prospectus, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or neither the Company nor any other state or federal healthcare program. The Company has not of its subsidiaries have 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 product, operation or activity is in material violation of any Health Care Laws, andLaws nor, to the Company’s knowledge, no is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Except as disclosed in the Registration Statement and the Prospectus, the Company and each of 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). Except as disclosed in the Registration Statement and the Prospectus, neither the Company nor any of its subsidiaries or, to the Company’s knowledge, any of their respective employees, officers, directors, or agents is not a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. AdditionallyExcept as disclosed in the Registration Statement and the Prospectus, neither the CompanyCompany nor any of its subsidiaries or any of their respective officers, nor directors, employees or, to the Company’s knowledge, any of its employees, officers or directors, agents has been excluded, suspended or debarred from participation in any U.S. state or federal health care healthcare 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, suspension suspension, or exclusion. 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 matters set forth therein. The Company acknowledges that Cowen and, for purposes of the opinions to be delivered pursuant to ‎Section 7 hereof, counsel to the Company and counsel to Cowen, will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.

Compliance with Health Care Laws. The Company has operated and currently is its subsidiaries are, and at all times have been, in compliance with all applicable health care lawsHealth Care Laws, rules and regulations (except where such failure to operate or non-be in compliance would notnot reasonably be expected to, singly individually or in the aggregate, result in a Material Adverse Effect). For purposes of this Agreement, including, without limitation, “Health Care Laws” means: (i) the Federal, Federal Food, Drug Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.)and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign healthcare health care related fraud and abuse laws, including, without limitation, the federal U.S. Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act Anti-Inducement Law (42 U.S.C. § 1320a-7h1320a-7a(a)(5)), the civil U.S. Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law (42 U.S.C. § 1320a-7b(a))all applicable federal, state, local and all foreign criminal laws relating to healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the healthcare 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)laws, the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the civil monetary penalties law (42 U.S.C. § 1320a-7a)regulations promulgated pursuant to such statutes; (iii) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated 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 or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, the regulations promulgated pursuant to such lawsthereunder; (v) the U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); (vi) quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vvii) any all other similar local, state, federal, national, supranational and foreign health laws, relating to the regulation of the Company or foreign laws (collectively, the “Health Care Laws”)any of its subsidiaries. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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 material violation of any Health Care Laws, andLaws nor, to the Company’s knowledge, no is any 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers or directors, directors 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 suspension, or exclusion.

Compliance with Health Care Laws. The Company has operated and currently is its subsidiaries are, and at all times have been, in compliance with all applicable health care lawsHealth Care Laws, rules and regulations (except where such failure to operate or non-be so in compliance would notnot reasonably be expected, singly individually or in the aggregate, to result in a Material Adverse Effect)Change. For purposes of this Agreement, including“Health Care Laws” means, without limitation, to the extent applicable to the Company’s operations: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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), 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 regulations promulgated pursuant to such lawsPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vvi) any all other similar local, state, federal, or national, supranational and foreign laws (collectivelylaws, the “Health Care Laws”). Neither the Company, nor relating to the Company’s knowledgeregulation of the Company or its subsidiaries, and (vii) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Except as would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Change, neither the Company nor any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, any of its subsidiaries nor any of their respective employees, officers, directors, or, to the Company’s knowledge, any of its employees, officers or directors, 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 suspension, or exclusion.

Compliance with Health Care Laws. The Company has operated and currently is its subsidiaries are, and at all times have been, in compliance with all applicable health care lawsHealth Care Laws, rules and regulations (except where such the failure to operate or non-compliance do so would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect)Change. For purposes of this Agreement, including, without limitation, “Health Care Laws” means: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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 exclusion laws Xxxxx Law (42 U.S.C. § 1320a-7Section 1395nn), and 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 regulations promulgated pursuant to such lawsPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vvi) any all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws its subsidiaries, and (collectively, vii) the “Health Care Laws”)directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any 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), except, with respect to any of the foregoing, such as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change. 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers or 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 subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension 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 has operated and currently is its subsidiaries are, and at all times have been, in compliance with all applicable health care lawsHealth Care Laws, rules and regulations (except where such failure to operate or non-be in compliance would notnot reasonably be expected to, singly individually or in the aggregate, result in a Material Adverse Effect). For purposes of this Agreement, including, without limitation, “Health Care Laws” means: (i) the Federal, Federal Food, Drug Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.)and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign healthcare health care related fraud and abuse laws, including, without limitation, the federal U.S. Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act Anti-Inducement Law (42 U.S.C. § 1320a-7h1320a-7a(a)(5)), the civil U.S. Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law (42 U.S.C. § 1320a-7b(a))all applicable federal, state, local and all foreign criminal laws relating to healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the healthcare 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)laws, the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the civil monetary penalties law (42 U.S.C. § 1320a-7a)regulations promulgated pursuant to such statutes; (iii) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated 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 or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, the regulations promulgated pursuant to such lawsthereunder; (v) the U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); (vi) quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vvii) any all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws (collectively, the “Health Care Laws”)any of its subsidiaries. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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 material violation of any Health Care Laws, andLaws nor, to the Company’s knowledge, no is any 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers or directors, directors 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 suspension, or exclusion.

Compliance with Health Care Laws. The Company has operated and currently is its subsidiaries are, and at all times have been, in material compliance with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare health care fraud criminal provisions under HIPAA, the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Xxxxx Law (42 U.S.C. Section 1320d et seq.1395nn), 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), 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 regulations promulgated pursuant to such lawsPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; and (v) any licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; (vi) all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws its subsidiaries; and (collectively, vii) the “Health Care Laws”)directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries has not received written notice or other correspondence of any material claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other material 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, andLaws nor, to the Company’s knowledge, no is any such material claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other material 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, any of its subsidiaries nor any of their respective employees, officers, directors, or, to the Company’s knowledge, any of its employees, officers or directors, 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’s knowledge, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could would reasonably be expected to result in debarment, suspension suspension, or exclusion.

Compliance with Health Care Laws. The Company has operated and currently is its subsidiaries are, and at all times since January 1, 2015 have been, in compliance with all applicable health care lawsHealth Care Laws, rules and regulations (except where such failure to operate or non-compliance noncompliance would not, not singly or in the aggregate, aggregate reasonably be expected to result in a Material Adverse Effect). For purposes of this Agreement, including, without limitation, “Health Care Laws” means: (i) the Federal, Federal Food, Drug Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.)and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, , the federal U.S. Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Statements 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 286 286, and 287, and the healthcare 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 exclusions law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); , (iv) Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), (v) the Public Health Service Act (42 U.S.C. § 201 et seq.), (vi) the regulations promulgated pursuant to such laws; statutes and any state or foreign counterpart thereof, (vvii) any other similar applicable local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign its subsidiaries, and (viii) any and all other applicable health care laws (collectively, the “Health Care Laws”)and regulations. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any 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 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 respects (or were corrected or supplemented by a subsequent submission), except where such failure would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect. 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, any of its subsidiaries nor any of their respective employees, officers, directors, or to the Company’s knowledge, any of its employees, officers or directors, 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 suspension, or exclusion.

Compliance with Health Care Laws. The Company has operated Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company, its subsidiaries and currently is its managed practices are, and for the past three years have been, in compliance with all applicable health care laws, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, (i) the Federal, Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) all applicable federal, state, local and all applicable foreign healthcare related fraud and abuse laws, including, without limitation, the federal Anti-kickback Statute (42 U.S.C. § 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the criminal False Claims Law (42 U.S.C. § 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 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. § 1320a-7a); (iii) HIPAA, as amended by the Health Information Technology for Economic Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) the regulations promulgated pursuant to such laws; and (v) any other similar local, state, federal, or foreign laws (collectively, the “Health Care Laws”). Neither the Company, nor to the Company’s knowledge, any of its officers, directors, employees or agents and have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicareany “federal health care program” as defined in 42 U.S.C. § 1320a-7b(f) (the “Federal Health Care Programs”). The term “Health Care Laws” means (i) all federal, Medicaidstate and local health care anti-kickback, self-referral, false claim, fraud and abuse laws and regulations, including the Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the Xxxxx Law (42 U.S.C. § 1395nn), the federal civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the criminal False Claims Act (42 U.S.C. § 1320a-7b(a)), the exclusions laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), 18 U.S.C. §§ 286 and 287 and the health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and any applicable state fraud and abuse prohibitions, including those that apply to workers’ compensation programs, commercial insurance plans, governmental healthcare programs; (ii) the Medicare Statute (Title XVIII of the Social Security Act); (iii) the Medicaid Statute (Title XIX of the Social Security Act); (iv) the TRICARE Statute (10 U.S.C. § 1071 et seq.); (v) HIPAA; (vi) all federal, state and local health care laws and regulations relating to licensure, accreditation and credentialing of healthcare professionals and facilities, quality and safety, scope of practice and supervision, corporate practice of medicine, therapy and other licensed healthcare professionals and professional fee-splitting; (vii) all federal, state and local health care laws and regulations relating to the billing, coding, reimbursement or submission of claims or collection of accounts receivable, copayments, or deductibles or refund of overpayments; (viii) any other applicable laws and regulations related to the ordering, dispensing, and diversion of controlled substances, including 21 U.S.C. § 801, et seq. (known as the “Controlled Substances Act”); (ix) state workers’ compensation and insurance laws and regulations; and (x) in each case, as amended, and all applicable implementing regulations, rules, ordinances and governmental orders related to any of the foregoing. Except as would not, individually or federal healthcare program. The Company in the aggregate, reasonably be expected to have a Material Adverse Effect, in the past three years, neither the Company, its subsidiaries nor its managed practices, has not received written notice or other correspondence of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action (“Action”) Action from any court or arbitrator or court, arbitrator, governmental or regulatory authority or third party alleging that of any product operation non-compliance or activity is in violation of any Health Care Laws, and, and to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action Action is threatened. The Company Neither the Company, its subsidiaries nor its managed practices, is not a party to and does not have or has any ongoing reporting obligations pursuant to any corporate integrity agreementagreements, deferred prosecution agreementagreements, monitoring agreementagreements, consent decree, decrees or settlement order, plan of correction orders with or similar agreement imposed by any governmental or regulatory authority. Additionally, neither Neither the Company, its subsidiaries, its managed practices, nor any of their respective employees, directors or officers, nor to the Company’s knowledge, any of its employees, officers or directorsagents, 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, proceedingfrom, or other similar action that could reasonably be expected to result in debarmentis otherwise ineligible for participation in, suspension or exclusionany Federal Health Care Programs.

Compliance with Health Care Laws. The Company has operated and currently is its subsidiaries are, and at all times have been, in compliance in all material respects with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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 exclusion laws Xxxxx Law (42 U.S.C. § 1320a-7Section 1395nn), and 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 regulations promulgated pursuant to such lawsPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vvi) any all other similar comparable local, state, federal, national, relating to the regulation of the Company or foreign laws its subsidiaries, and (collectively, vii) the “Health Care Laws”)directives and regulations promulgated pursuant to such statutes and any state thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor any of its subsidiaries has received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other communication or notice from FDA or other Regulatory Agency. 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its subsidiaries, nor to the knowledge of the Company any of its or their respective employees, officers officers, or directors, directors 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 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 has operated and currently is its subsidiaries are, and at all times have been, in compliance in all material respects with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare health care fraud criminal provisions under HIPAA, the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Xxxxx Law (42 U.S.C. Section 1320d et seq.1395nn), 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), 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 regulations promulgated pursuant to such lawsPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vvi) any all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws its subsidiaries, and (collectively, vii) the “Health Care Laws”)directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any 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 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 not a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor any of its subsidiaries nor, to the knowledge of the Company’s knowledge, any of its their respective employees, officers or 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 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 has operated and currently is its subsidiaries are, and at all times have been, in compliance with all applicable health care laws, rules and regulations (Health Care Laws except where such failure as would not reasonably be expected to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect)Change. For purposes of this Agreement, including, without limitation, “Health Care Laws” means: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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 exclusion laws (42 U.S.C. § 1320a-7), and the civil monetary penalties law (42 U.S.C. § Section 1320a-7a); , the exclusion law (iii) HIPAA42 U.S.C. Section 1320a-7), as amended by the Health Information Technology for Economic Clinical Health Physician Payments Sunshine Act (42 U.S.C. Section 17921 et seq.1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iviii) the regulations promulgated pursuant to such laws; and (v) any all other similar local, state, federal, or national, supranational and foreign laws (collectivelylaws, the “Health Care Laws”). Neither the Company, nor relating to the Company’s knowledgeregulation of the Company or its subsidiaries, and (iv) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. During the past three (3) years, neither the Company nor any of its 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 subsidiaries 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 material violation of any Health Care Laws, andLaws nor, to the knowledge of the Company’s knowledge, no is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The During the past three (3) 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 not a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither none of the Company, nor to the Company’s knowledge, any of its subsidiaries or any of their respective employees, officers or officers, directors, or, to the knowledge of the Company, 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 would reasonably be expected to result in debarment, suspension 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(p) 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 has operated and currently is its subsidiaries are, and at all times have been, in compliance with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (collectively, “HIPAA”) ), (42 U.S.C. Section 1320d et seq.), the exclusion laws Sxxxx Law (42 U.S.C. § 1320a-7Section 1395nn), and 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 regulations promulgated pursuant to such lawsPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vvi) any all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws its subsidiaries, and (collectively, vii) the “Health Care Laws”)directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers or 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 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 has operated and currently is its subsidiaries are, and at all times have been, in compliance with all applicable health care laws, rules and regulations (Health Care Laws except where such failure to operate or the extent that any non-compliance would not, singly individually or in the aggregate, result in reasonably be expected to have a Material Adverse Effect). For purposes of this Agreement, including, without limitation, “Health Care Laws” means: (i) the Federal, Federal Food, Drug Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.)and the regulations promulgated thereunder; (ii) all applicable federal, state, and local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, , the federal U.S. Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Statements 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 healthcare 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 Xxxxx Law (42 U.S.C. § 1320a-7Section 1395nn), and the civil monetary penalties law (42 U.S.C. § Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), and 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 regulations promulgated pursuant to such lawsPhysician Payment Sunshine Act (42 U.S.C. § 1320a-7h); (v) licensure, quality, safety and accreditation requirements under applicable federal, state, or local laws or regulatory bodies; and (vvi) any all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws its subsidiaries, and (collectively, vii) the “Health Care Laws”)directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect. 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor any of its subsidiaries nor, to the knowledge of the Company’s knowledge, any of its their respective employees, officers or 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 subject to a governmental inquiry, investigation, proceeding, or other similar action that could would reasonably be expected to result in debarment, suspension suspension, or exclusion.

Compliance with Health Care Laws. The Company has operated and currently is its subsidiaries are, and have been since January 1, 2019, in material compliance with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (i) the Federal, Federal Food, Drug Drug, and Cosmetic Act; the Public Health Service Act (21 42 U.S.C. §§ 301 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal U.S. Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Statements 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 286, 287, 1035, 1347, and 1349, the healthcare 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 exclusions law (42 U.S.C. Section 1320a-7), laws governing government funded or sponsored healthcare programs; (iiiii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iii) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (iv) the regulations promulgated pursuant to such lawslicensure and accreditation requirements under applicable federal, state, applicable local or foreign laws or regulatory bodies; and (v) any all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws its subsidiaries, and (collectivelyvi) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof, except for any such noncompliance or violation that would not, individually or in the “Health Care Laws”)aggregate, have a Material Adverse Effect. Neither the Company, nor to the Company’s knowledge, any of its subsidiaries, nor any of their respective 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 liability under a Health Care Law. Neither the Company nor any other state or federal healthcare program. The Company of its subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any 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 material 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, any of its subsidiaries, nor, to the Company’s knowledge, any of their respective employees, officers, directors, or agents is not a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor any of its subsidiaries nor, to the Company’s knowledge, any of its their respective employees, officers or 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 subject to a governmental inquiry, investigation, proceeding, or other similar action that could would reasonably be expected to result in debarment, suspension suspension, or exclusion.

Compliance with Health Care Laws. The Company has operated and currently is its subsidiaries are, and at all times have been, in compliance with all applicable health care lawsHealth Care Laws, rules and regulations (except where such failure to operate or non-be so in compliance would notnot reasonably be expected, singly individually or in the aggregate, result in to have a Material Adverse Effect). For purposes of this Agreement, including, without limitation, “Health Care Laws” means: (i) the Federal, Federal Food, Drug Drug, and Cosmetic Act (21 U.S.C. §§ Section 301 et seq.)) and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign healthcare health care related fraud and abuse laws, including, without limitation, the federal U.S. Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act Civil Monetary Penalties Laws (42 U.S.C. § 1320a-7hSection 1320a-7a), the civil U.S. Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law (42 U.S.C. § 1320a-7b(a))all applicable federal, all state, local and foreign criminal laws relating to healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the healthcare 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. § Section 1320a-7), the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the civil monetary penalties law regulations promulgated pursuant to such statutes; (iii) the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7aSection 1320-7h); (iiiiv) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the data privacy and security regulations promulgated thereunder; (ivv) the Patient Protection and Affordable Care Act of 2010 (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 thereunder; (vi) the U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); (vii) quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies, including, but not limited to, all laws applicable to such lawsownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company; and (vviii) any all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws (collectively, the “Health Care Laws”)its subsidiaries. Neither the Company, Company nor to the Company’s knowledge, any of its officers, directors, employees or agents 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 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, andLaws nor, to the Company’s knowledge, no is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Except as would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect, the Company is not 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 its subsidiaries are a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, its subsidiaries nor to the Company’s knowledge, any of its their respective employees, officers or directors, directors 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 would reasonably be expected to result in debarment, suspension suspension, or exclusion.

Compliance with Health Care Laws. The Company has operated and currently is its subsidiaries are, and at all times have been, in compliance with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (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; (ii) all applicable U.S. federal, state, local and all applicable foreign healthcare related non-U.S. health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare 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 Sxxxx Law (42 U.S.C. § 1320a-7Section 1395nn), and 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; and (vi) all other local, state, U.S. federal, national, supranational and non-U.S. laws, relating to the regulation of the Company or its subsidiaries, and (vii) the directives and regulations promulgated pursuant to such laws; statutes and (v) any other similar local, state, federal, state or foreign laws (collectively, the “Health Care Laws”)non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers or 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 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 has operated and currently is its subsidiaries are, and at all times have been, in compliance with all applicable health care lawsHealth Care Laws. For purposes of this Agreement, rules and regulations (except where such failure to operate or non-compliance would not, singly or in the aggregate, result in a Material Adverse Effect), including, without limitation, “Health Care Laws” means: (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; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Law false statements 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 healthcare health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (collectively, “HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws Xxxxx Law (42 U.S.C. § 1320a-7Section 1395nn), and 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 regulations promulgated pursuant to such lawsPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vvi) any all other similar local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws its subsidiaries, and (collectively, vii) the “Health Care Laws”)directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers or 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 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 has operated and currently is its subsidiaries are, and at all times have been, in compliance with all applicable health care laws, rules and regulations (Health Care Laws except where such failure to operate or the extent that any non-compliance would not, singly individually or in the aggregate, result in reasonably be expected to have a Material Adverse Effect). For purposes of this Agreement, including, without limitation, “Health Care Laws” means: (i) the Federal, Federal Food, Drug Drug, and Cosmetic Act (21 U.S.C. §§ Section 301 et seq.)) and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign healthcare related health care fraud and abuse laws, including, without limitation, the federal Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil Civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal False Claims Statements 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 286 286, 287 and 287, the healthcare 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 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), the Physician Payments Sunshine Act (42 U.S.C. Section 1320a-7h), and the laws governing government funded or sponsored healthcare programs including, but not limited to, Medicare (Title XVIII of the Social Security Act) and Medicaid (Title XIX of the Social Security Act); (iii) HIPAA, as amended by the Health Information Technology for Economic Clinical Health HITECH Act (42 U.S.C. Section 17921 et seq.); (iv) the regulations promulgated pursuant to such lawsPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; and (v) any all other similar applicable local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or foreign laws its subsidiaries; and (collectively, vi) the “Health Care Laws”)directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company, Company nor to the Company’s knowledge, any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect. 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 agreement, deferred prosecution agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor any of its subsidiaries nor, to the knowledge of the Company’s knowledge, any of its their respective employees, officers or officers, directors, contractors 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 would reasonably be expected to result in debarment, suspension suspension, or exclusion.

Compliance with Health Care Laws. The Company has operated and currently is its subsidiaries are, and at all times have been, in compliance with all applicable health care lawsHealth Care Laws, rules and regulations (except where such failure to operate or non-compliance do so would not, singly or in the aggregate, result in not reasonably be expected to have a Material Adverse Effect). For purposes of this Agreement, including, without limitation, “Health Care Laws” means: (i) the Federal, Federal Food, Drug Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign healthcare health care related fraud and abuse laws, including, without limitation, including the federal U.S. Anti-kickback Kickback Statute (42 U.S.C. § Section 1320a-7b(b)), the U.S. Physician Payments Sunshine Act federal criminal false claims law (42 U.S.C. § 1320a-7h1320a-7b), the federal 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 criminal False Claims Xxxxx Law (42 U.S.C. § 1320a-7b(a1395nn), the exclusion laws (42 U.S.C. § 1320a-7), all applicable federal, state, local and all foreign criminal laws relating to healthcare health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the healthcare health care fraud criminal provisions under HIPAA, (ii) the U.S. Health Insurance Portability statutes, regulations and Accountability Act directives of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7)applicable government funded or sponsored healthcare programs, and the civil monetary penalties law (42 U.S.C. § 1320a-7a)regulations promulgated pursuant to such statutes; (iii) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, as amended by the HITECH Act, and the regulations promulgated thereunder and any state counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the Patient Protection and Affordable Care Act of 2010 (Public Law 111-148), as amended by the Health Information Technology for Economic Clinical Health Care and Education Reconciliation Act of 2010 (Public Law 111-152), the regulations promulgated thereunder; (v) the U.S. Controlled Substances Act (42 21 U.S.C. Section 17921 801 et seq.); (ivvi) quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; (vii) Medicare, Title XVIII of the regulations promulgated pursuant to such lawsSocial Security Act, Medicaid, Title XIX of the Social Security Act; and (vviii) any all other similar local, state, federal, or national, supranational and foreign laws (collectivelylaws, the “Health Care Laws”). Neither the Company, nor relating to the Company’s knowledgeregulation of the Company or its subsidiary. Except as otherwise disclosed in the SEC Documents, neither the Company nor any of its 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 subsidiaries 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, andLaws nor, to the Company’s knowledge, no is any 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 required and 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 not a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreementagreements, deferred prosecution agreementplans of correction, monitoring agreementagreements, consent decreedecrees, settlement orderorders, plan of correction or similar agreement agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor to the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers or directors, directors 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 suspension, or exclusion.