Common use of Compliance with Health Care Laws Clause in Contracts

Compliance with Health Care Laws. The Company and its Subsidiaries are in compliance with applicable Health Care Laws, except for any noncompliance that would not reasonably be expected to have a Material Adverse Change. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) 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, 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; (iii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiaries. Neither the Company nor its Subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action 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 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 any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity. Additionally, neither the Company, its Subsidiaries nor, to the Company’s knowledge, any of their respective employees, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its Subsidiaries are subsidiaries are, and at all times have been, in compliance in all material respects with applicable all Health Care Laws, except for any noncompliance that would not reasonably be expected to have a Material Adverse Change. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”21 U.S.C. Section 301 et seq.), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, the Public Health Information Technology for Economic and Clinical Health Service Act (42 U.S.C. Section 17921 201 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 prescribersthereunder; (iiiii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (iviii) all other applicable local, state, federal, national, supranational and foreign laws, laws relating to the regulation of the Company or its Subsidiariessubsidiaries; and (iv) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any of its Subsidiaries have subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its Subsidiaries 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, complete and 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 any of its Subsidiaries are subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority. Additionally, neither the Company, any of its Subsidiaries subsidiaries nor, to the Company’s knowledge, any of their respective employees, officers officers, directors, or directors agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its Subsidiaries are are, and at all times have been, in compliance in all material respects with applicable all Health Care LawsLaws (defined below). Neither the Company, except any of its Subsidiaries, nor any of their respective officers, directors, employees or agents have engaged in activities which are, as applicable, cause for any noncompliance that would not reasonably be expected to have liability under a Material Adverse Change. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) 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, 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; (iii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its SubsidiariesLaw. Neither the Company nor any of its Subsidiaries have has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company Company, and to the Company’s knowledge, its Subsidiaries 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, complete and 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 Company, any of its Subsidiaries are Subsidiaries, nor, to the Company’s knowledge, any of their respective employees, officers, directors, or agents is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity. Additionally, neither the Company, any of its Subsidiaries nor, to the Company’s knowledge, nor any of their respective employees, officers officers, directors, or directors agents has been excluded, suspended or debarred from participation in any U.S. or Canadian federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its Subsidiaries subsidiaries are in compliance with applicable Health Care Laws, except for any noncompliance that would not reasonably be expected to have a Material Adverse ChangeEffect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) 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, 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; (iii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiariessubsidiaries. Neither the Company nor its Subsidiaries subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its Subsidiaries 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 subsidiaries are a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority. Additionally, neither the Company, its Subsidiaries nor, to the Company’s knowledge, subsidiaries nor any of their respective employees, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and each of its Subsidiaries are subsidiaries are, and at all times have been, in compliance with all applicable Health Care LawsLaws and to the extent applicable to the Company’s current business and product candidates, except for to the extent that any noncompliance that non-compliance would not not, individually or in the aggregate, reasonably be expected to have a Material Adverse ChangeEffect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act; the Public Health Service Act (42 U.S.C. §§ 201 et seq.), and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”)all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)); (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 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; (iiiiv) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (ivv) all other applicable local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company Company’s current business and product candidates; and (vi) the directives and regulations promulgated pursuant to such statutes and any state or its Subsidiariesnon-U.S. counterpart thereof. Neither the Company nor any of its Subsidiaries subsidiaries, nor any of its respective officers, directors, employees or, to the Company’s knowledge, agents have engaged in activities which materially violate a Health Care Law. Neither the Company nor any of its subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect. The Company and its Subsidiaries 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, complete and 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 any of its Subsidiaries are subsidiaries, nor any of its respective employees, officers, directors, or, to the Company’s knowledge, agents is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries, nor any of its respective employees, officers, or directors, and, to the knowledge of the Company, its Subsidiaries nor, to the Company’s knowledge, any of their respective employees, officers or directors agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its Subsidiaries are Except as would not, individually or in compliance with applicable Health Care Lawsthe aggregate, except for any noncompliance that would not have or may reasonably be expected to have a Material Adverse Change. For purposes of this Agreement, “Health Care Laws” meansEffect: (i) the Company’s and each of its subsidiaries’ business practices have been structured in a manner designed to comply with state, federal and foreign laws applicable to the Company and its subsidiaries respective businesses, and the Company and its subsidiaries are in compliance with such laws including, without limitation, applicable provisions of: (A) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder; (ii) 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, 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 prescribersprescribers (collectively, “Health Care Laws”); (iiiii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiaries. Neither neither the Company nor its Subsidiaries subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity governmental or regulatory authority or third party alleging that any product product, operation or activity is in material violation of any Health Care Laws nor, to the knowledge of the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The ; (iii) neither the Company nor any subsidiary has received written notice that any court or arbitrator or governmental or regulatory authority with relevant jurisdiction has taken, is taking or intends to take action to limit, suspend, modify or revoke applicable Permits or has any knowledge that any such court or arbitrator or governmental or regulatory authority is considering such action; (iv) the Company and its Subsidiaries 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, complete and accurate and not misleading on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither ; (v) neither the Company nor its Subsidiaries subsidiaries are a party to any corporate integrity agreements, monitoring agreements, consent decrees, plans of correction, settlement orders, or similar agreements with or imposed by any Governmental Entity. Additionally, governmental or regulatory authority; and (vi) neither the Company, its Subsidiaries nor, to the Company’s knowledge, subsidiaries nor any of their respective officers, directors, employees, officers or directors has agents have been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company is, and its Subsidiaries are at all times has been, in compliance with all applicable Health Care LawsLaws and to the extent applicable to the Company’s current business and product candidates, except for to the extent that any noncompliance that non-compliance would not not, individually or in the aggregate, reasonably be expected to have a Material Adverse ChangeEffect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act; the Public Health Service Act (42 U.S.C. §§ 201 et seq.), and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”)all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)); (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 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; (iiiiv) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (ivv) all other applicable local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company Company’s current business and product candidates; and (vi) the directives and regulations promulgated pursuant to such statutes and any state or its Subsidiariesnon-U.S. counterpart thereof. Neither the Company nor any of its Subsidiaries respective officers, directors, employees or, to the Company’s knowledge, agents have engaged in activities which materially violate a Health Care Law. The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect. The Company and its Subsidiaries have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were timely, complete, complete and 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 any of its Subsidiaries are respective employees, officers, directors, or, to the Company’s knowledge, agents is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority. Additionally, neither the Company nor any of its respective employees, officers, or directors, and, to the knowledge of the Company, its Subsidiaries nor, to the Company’s knowledge, any of their respective employees, officers or directors agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could would reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its Subsidiaries are subsidiaries are, and at all times have been, in compliance with applicable all Health Care Laws, except for any noncompliance that would not reasonably be expected Laws in all material respects and to have a Material Adverse Changethe extent applicable to the Company’s current business. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”)all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)); (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 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; (iiiiv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (ivvi) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiariessubsidiaries, and (vii) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any of its Subsidiaries have subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its Subsidiaries 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, complete and 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 any of its Subsidiaries are subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority. Additionally, neither the Company, any of its Subsidiaries norsubsidiaries nor any of their respective employees, officers, directors, or, to the Company’s knowledge, any of their respective employees, officers or directors agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company’s knowledge, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its Subsidiaries subsidiaries are in compliance with applicable Health Care Laws, except for any noncompliance that would not reasonably be expected to have a Material Adverse ChangeEffect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) as amended by the Health Information Technology for Economic and Clinical Health Act, including but not limited to the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.)Sets, and the other 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; (iii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiariessubsidiaries. Neither the Company nor its Subsidiaries subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its Subsidiaries 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 subsidiaries are a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority. Additionally, neither the Company, its Subsidiaries nor, to the Company’s knowledge, subsidiaries nor any of their respective employees, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and each of its Subsidiaries are in compliance with applicable Health Care Laws, except for any noncompliance that would not reasonably be expected to have a Material Adverse Change. For purposes of this Agreement, “Health Care Laws” means: subsidiaries (i) is, and since its inception has been in compliance in all material respects with all statutes, rules and regulations applicable to the Company’s business, including but not limited to statutes, rules and regulations related to the ownership, testing, development, registration, licensure, manufacture, processing, use, recordkeeping, filing of reports, storage, import, export or disposal of any product candidate developed or manufactured by or on behalf of the Company or such subsidiary, including, without limitation, the Federal Food, Drug, Drug and Cosmetic Act and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”21 U.S.C. § 301 et seq.), the Security StandardsPublic Health Service Act (42 U.S.C. § 262 et seq.), the Health Insurance Portability and the Standards for Electronic Transactions and Code Sets promulgated under HIPAAAccountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.)of 2009, and the regulations promulgated thereunder pursuant to such laws, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and any 312, the U.S. Animal Welfare Act and comparable 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; (iii) licensurelaws, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (iv) all other local, state, federal, national, supranational national and foreign laws, relating rules, and regulations, applicable to the regulation of the Company or any of its Subsidiaries. Neither subsidiaries (collectively, the “Applicable Laws”), in each case except where such noncompliance with Applicable Laws would not, singly or in the aggregate, reasonably be expected to have a material adverse effect on the Company nor and its Subsidiaries subsidiaries, taken as a whole; (ii) has not received, directly or indirectly, any written notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), in each case, except where such noncompliance would not, singly or in the aggregate, reasonably be expected to have received a material adverse effect on the Company and its subsidiaries, taken as a whole; (iii) possesses all Authorizations and such Authorizations are valid and in full force and effect and is not in violation of any term of any such Authorizations, except where such violation, would not, singly or in the aggregate, reasonably be expected to have a material adverse effect on the Company and its subsidiaries, taken as a whole; (iv) has not received, directly or indirectly, any written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action action, or notice of adverse finding, any FDA Form 483, warning letter, untitled letter or other communication, from any court governmental or arbitrator regulatory authority alleging or Governmental Entity asserting noncompliance with any Applicable Laws or third party alleging that any product operation or activity is in material violation of any Health Care Laws Authorizations, nor, to the knowledge of the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action or communication threatened. The , in each case, except where such noncompliance would not, singly or in the aggregate, reasonably be expected to have a material adverse effect on the Company and its Subsidiaries have subsidiaries, taken as a whole; (v) has not received written notice from any court or arbitrator or governmental or regulatory authority that such court, arbitrator or authority has taken, is taking or intends to take action to materially limit, suspend, materially modify or revoke any Authorizations, nor, to the knowledge of the Company, is any such limitation, suspension, modification or revocation threatened; (vi) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were timely, complete, complete and 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 ; and (vii) is not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity. Additionally, neither the Company, its Subsidiaries nor, to the Company’s knowledge, any of their respective employees, officers governmental or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusionregulatory authority.

Compliance with Health Care Laws. The Company and, to the Company’s knowledge, its directors, officers, employees, and its Subsidiaries are agents (while acting in such capacity) are, and at all times prior hereto have been, in compliance with with, all health care laws and regulations applicable Health Care Lawsto the Company or any of its product candidates or activities, except for including development and testing of medical devices, kickbacks, recordkeeping, documentation requirements, the hiring of employees (to the extent governed by health care laws), quality, safety, privacy, security, licensure, accreditation or any noncompliance that would not reasonably be expected to have a Material Adverse Change. For purposes other aspect of this Agreementdeveloping and testing health care or medical device products (collectively, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), except where such noncompliance would not, individually or in the Security Standardsaggregate, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAAhave a Material Adverse Effect. The Company has not received any written notification, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.)correspondence or any other written communication, 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; (iii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiaries. Neither the Company nor its Subsidiaries have received written notice including notification of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court governmental authority, including, without limitation, the United States Food and Drug Administration (“FDA”), the Drug Enforcement Agency (“DEA”), the Centers for Medicare & Medicaid Services, and the U.S. Department of Health and Human Services Office of Inspector General, of potential or arbitrator actual non-compliance by, or Governmental Entity or third party alleging that any product operation or activity is in material violation of liability of, the Company under any Health Care Laws nor, to Laws. To the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration there are no facts or other action threatened. The circumstances that would reasonably be expected to give rise to liability of 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 under any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements except that would not individually or amendments were timely, complete, accurate and not misleading on in the date filed in all material respects (or were corrected or supplemented by aggregate have a subsequent submission)Material Adverse Effect. Neither the Company nor its Subsidiaries are a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity. Additionally, neither the Company, its Subsidiaries nor, to To the Company’s knowledge, the manufacture of Company products by or on behalf of the Company is being conducted in compliance with all Health Care Laws applicable to the Company or any of their its products or activities, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 C.F.R. Part 820 for medical devices or Parts 210-211 for biological products, when sold in the United States, and the respective employeescounterparts thereof promulgated by governmental authorities in countries outside the United States. Except as disclosed in the Registration Statement, officers the Prospectus and any Permitted Free Writing Prospectus (as defined below) or directors as would not reasonably be expected to have a Material Adverse Effect, during the three year period ended on December 31, 2018 and through the date hereof, the Company has been excluded, suspended not had any product or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is Company owned manufacturing site subject to a governmental inquiryauthority (including FDA) shutdown or import or export prohibition, investigationnor received any FDA Form 483 or other governmental authority notice of inspectional observations, proceeding“warning letters,” “untitled letters,” requests to make changes to the Company products, processes or operations, or similar correspondence or notice from the FDA or other similar action that could reasonably be expected governmental authority alleging or asserting material noncompliance with any applicable Health Care Laws. To the Company’s knowledge, neither the FDA nor any other governmental authority has threatened such action. The Company is in compliance in all material respects with all applicable regulatory post-market reporting obligations, including, without limitation, the FDA’s adverse event reporting requirements at 21 CFR Parts 310, 314, 600, and 803, and, to result the extent applicable, the respective counterparts thereof promulgated by governmental authorities in debarment, suspension, or exclusioncountries outside the United States.

Compliance with Health Care Laws. The Company and, to the Company’s knowledge, its directors, officers, employees, and its Subsidiaries are agents (while acting in such capacity) are, and at all times prior hereto have been, in compliance with with, all health care laws and regulations applicable Health Care Lawsto the Company or any of its product candidates or activities, except for including development and testing of medical devices, kickbacks, recordkeeping, documentation requirements, the hiring of employees (to the extent governed by health care laws), quality, safety, privacy, security, licensure, accreditation or any noncompliance that would not reasonably be expected to have a Material Adverse Change. For purposes other aspect of this Agreementdeveloping and testing health care or medical device products (collectively, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), except where such noncompliance would not, individually or in the Security Standardsaggregate, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAAhave a Material Adverse Effect. The Company has not received any written notification, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.)correspondence or any other written communication, 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; (iii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiaries. Neither the Company nor its Subsidiaries have received written notice including notification of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court governmental authority, including, without limitation, the United States Food and Drug Administration (“FDA”), the Drug Enforcement Agency (“DEA”), the Centers for Medicare & Medicaid Services, and the U.S. Department of Health and Human Services Office of Inspector General, of potential or arbitrator actual non-compliance by, or Governmental Entity or third party alleging that any product operation or activity is in material violation of liability of, the Company under any Health Care Laws nor, to Laws. To the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration there are no facts or other action threatened. The circumstances that would reasonably be expected to give rise to liability of 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 under any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements except that would not individually or amendments were timely, complete, accurate and not misleading on in the date filed in all material respects (or were corrected or supplemented by aggregate have a subsequent submission)Material Adverse Effect. Neither the Company nor its Subsidiaries are a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity. Additionally, neither the Company, its Subsidiaries nor, to To the Company’s knowledge, the manufacture of Company products by or on behalf of the Company is being conducted in compliance with all Health Care Laws applicable to the Company or any of their its products or activities, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 C.F.R. Part 820 for medical devices or Parts 210-211 for biological products, when sold in the United States, and the respective employeescounterparts thereof promulgated by governmental authorities in countries outside the United States. Except as disclosed in the Registration Statement, officers and the Prospectus or directors as would not reasonably be expected to have a Material Adverse Effect, during the three year period ended on December 31, 2018 and through the date hereof, the Company has been excluded, suspended not had any product or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is Company owned manufacturing site subject to a governmental inquiryauthority (including FDA) shutdown or import or export prohibition, investigationnor received any FDA Form 483 or other governmental authority notice of inspectional observations, proceeding“warning letters,” “untitled letters,” requests to make changes to the Company products, processes or operations, or similar correspondence or notice from the FDA or other similar action that could reasonably be expected governmental authority alleging or asserting material noncompliance with any applicable Health Care Laws. To the Company’s knowledge, neither the FDA nor any other governmental authority has threatened such action. The Company is in compliance in all material respects with all applicable regulatory post-market reporting obligations, including, without limitation, the FDA’s adverse event reporting requirements at 21 CFR Parts 310, 314, 600, and 803, and, to result the extent applicable, the respective counterparts thereof promulgated by governmental authorities in debarment, suspension, or exclusioncountries outside the United States.

Compliance with Health Care Laws. The Company Except as described in the Registration Statement and its Subsidiaries are the Prospectus, and except as would not, singly or in compliance with applicable Health Care Lawsthe aggregate, except for any noncompliance that would not have or reasonably be expected to have a Material Adverse Change. For purposes of this Agreement, “Health Care Laws” meansEffect: (i) neither the Federal FoodCompany nor its subsidiaries has received any written notice of adverse finding, Drugwarning letter, and Cosmetic Act and untitled letter or other correspondence or notice from the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”)FDA, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, 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 EMA or other law relevant regulatory authorities, or regulation the purpose of which is to protect the privacy of individuals any other court or prescribers; (iii) licensure, quality, safety and accreditation requirements under applicable arbitrator or federal, state, local or foreign laws governmental or regulatory bodies; authority, alleging or asserting material noncompliance with the Federal Food, Drug and Cosmetic Act (iv) all other local21 U.S.C. § 301 et seq.), as amended, and the regulations promulgated thereunder (the “FFDCA”), or similar state, federalfederal or foreign law or regulation (collectively, national, supranational and foreign laws, relating to the regulation of “Health Care Laws”); (ii) the Company or and its Subsidiaries. Neither subsidiaries are and have been in compliance in all material respects with applicable Health Care Laws; (iii) neither the Company nor its Subsidiaries have subsidiaries received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court U.S. or non-U.S. federal, national, state, local or other governmental or regulatory authority, governmental or regulatory agency or body, court, arbitrator or self-regulatory organization (each, a “Governmental Entity Authority”) or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to Laws; (iv) the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its Subsidiaries 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 applicable Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were timely, complete, accurate correct and not misleading on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither ; (v) neither the Company nor its Subsidiaries are subsidiaries or any of their respective directors, officers, employees or agents is or has been debarred, suspended or excluded, or has been convicted of any crime or engaged in any conduct that would result in a debarment, suspension or exclusion from any federal or state government health care program; and (vi) the Company is not a party to and the Company does not have any ongoing reporting obligations pursuant to, any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any an Governmental Entity. Additionally, neither the Company, its Subsidiaries nor, to the Company’s knowledge, any of their respective employees, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusionAuthority.

Compliance with Health Care Laws. The Company and, to the Company’s knowledge, its directors, officers, employees, and its Subsidiaries are agents (while acting in such capacity) are, and at all times prior hereto have been, in compliance with with, all health care laws and regulations applicable Health Care Lawsto the Company or any of its product candidates or activities, except for including development and testing of medical devices, kickbacks, recordkeeping, documentation requirements, the hiring of employees (to the extent governed by health care laws), quality, safety, privacy, security, licensure, accreditation or any noncompliance that would not reasonably be expected to have a Material Adverse Change. For purposes other aspect of this Agreementdeveloping and testing health care or medical device products (collectively, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), except where such noncompliance would not, individually or in the Security Standardsaggregate, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAAhave a Material Adverse Effect. The Company has not received any written notification, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.)correspondence or any other written communication, 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; (iii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiaries. Neither the Company nor its Subsidiaries have received written notice including notification of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court governmental authority, including, without limitation, the United States Food and Drug Administration (“FDA”), the Drug Enforcement Agency (“DEA”), the Centers for Medicare & Medicaid Services, and the U.S. Department of Health and Human Services Office of Inspector General, of potential or arbitrator actual non-compliance by, or Governmental Entity or third party alleging that any product operation or activity is in material violation of liability of, the Company under any Health Care Laws nor, to Laws. To the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration there are no facts or other action threatened. The circumstances that would reasonably be expected to give rise to liability of 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 under any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements except that would not individually or amendments were timely, complete, accurate and not misleading on in the date filed in all material respects (or were corrected or supplemented by aggregate have a subsequent submission)Material Adverse Effect. Neither the Company nor its Subsidiaries are a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity. Additionally, neither the Company, its Subsidiaries nor, to To the Company’s knowledge, the manufacture of Company products by or on behalf of the Company is being conducted in compliance with all Health Care Laws applicable to the Company or any of their its products or activities, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 C.F.R. Part 820 for medical devices or Parts 210-211 for biological products, when sold in the United States, and the respective employeescounterparts thereof promulgated by governmental authorities in countries outside the United States. Except as disclosed in the Registration Statement, officers the Prospectus and any Permitted Free Writing Prospectus (as defined below) or directors as would not reasonably be expected to have a Material Adverse Effect, during the three year period ended on December 31, 2017 and through the date hereof, the Company has been excluded, suspended not had any product or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is Company owned manufacturing site subject to a governmental inquiryauthority (including FDA) shutdown or import or export prohibition, investigationnor received any FDA Form 483 or other governmental authority notice of inspectional observations, proceeding“warning letters,” “untitled letters,” requests to make changes to the Company products, processes or operations, or similar correspondence or notice from the FDA or other similar action that could reasonably be expected governmental authority alleging or asserting material noncompliance with any applicable Health Care Laws. To the Company’s knowledge, neither the FDA nor any other governmental authority has threatened such action. The Company is in compliance in all material respects with all applicable regulatory post-market reporting obligations, including, without limitation, the FDA’s adverse event reporting requirements at 21 CFR Parts 310, 314, 600, and 803, and, to result the extent applicable, the respective counterparts thereof promulgated by governmental authorities in debarment, suspension, or exclusioncountries outside the United States.

Compliance with Health Care Laws. The Company and its Subsidiaries subsidiaries (A) are and at all times have been, in all material respects, in compliance with all statutes, rules, and regulations applicable Health Care Lawsto the ownership, except for research, testing, development, manufacture, packaging, processing, use, storage, import, export or disposal of any noncompliance that would not reasonably be expected to have a Material Adverse Change. For purposes product candidates of this Agreementthe Company or its subsidiaries, “Health Care Laws” means: (i) including, without limitation, the Federal Food, Drug, Drug and Cosmetic Act and the regulations promulgated thereunder; (ii) 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, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 21 U.S.C.§ 301 et seq.), and the regulations promulgated thereunder pursuant to such laws, and any successor government programs, and comparable 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; (iii) licensurelaws, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (iv) all other local, state, federal, national, supranational and foreign laws, rules, regulations, policies and final administrative guidance relating to the regulation of the Company (collectively, the “Applicable Regulatory Laws”); (B) possess all licenses, exemptions, certificates, approvals, consents, clearances, authorizations, permits, registrations and supplements or its Subsidiaries. Neither amendments thereto required by any such Applicable Regulatory Laws (“Regulatory Authorizations”) and such Regulatory Authorizations are valid and in full force and effect; (C) are in compliance, in all material respects, with and are not in violation of, or in default under, any such Regulatory Authorization, and to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation, termination or modification of any Regulatory Authorization or result in any other material impairment of the rights of the holder of any Regulatory Authorization, and the Company nor its Subsidiaries does not have any reason to believe that any Regulatory Authorization will not be renewed in the ordinary course; (D) have not received written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking, or intends to take action to limit, suspend, modify or revoke any Regulatory Authorizations nor, to the Company’s knowledge, is any such limitation, suspension, modification or revocation threatened; (E) have not received any notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action action, or any U.S. Food and Drug Administration (“FDA”) Form 483, notice of adverse finding, warning letter, untitled letter or other communication from any court or arbitrator or Governmental Entity governmental or third party regulatory authority alleging that or asserting non-compliance with any product operation Applicable Regulatory Laws or activity is in material violation of any Health Care Laws Regulatory Authorizations, nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action or communication threatened. The Company and its Subsidiaries ; (F) 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 LawsApplicable Regulatory Laws or Regulatory Authorizations, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were timely, complete, complete and 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 ; and (G) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority. AdditionallyExcept as described in the Registration Statement or Prospectus, neither the Company, its Subsidiaries nor, to none of the Company’s knowledge, or its subsidiaries’ product candidates has received marketing approval from any of their respective employees, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusionRegulatory Authority.

Compliance with Health Care Laws. The Company and its Subsidiaries are subsidiaries are, and at all times have been, in compliance with applicable all Health Care Laws, except for any noncompliance that would not reasonably be expected to have a Material Adverse Change. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”)all applicable federal, the Security Standardsstate, local and foreign health care fraud and abuse laws, and the Standards for Electronic Transactions and Code Sets promulgated under applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and 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; (iii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiariessubsidiaries, and (v) the regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any of its Subsidiaries have subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity governmental or third party regulatory authority alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its Subsidiaries 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, complete and 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 any of its Subsidiaries are subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority. Additionally, neither the Company, any of its Subsidiaries nor, to the Company’s knowledge, subsidiaries nor any of their respective employees, officers officers, directors, or directors agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Except as described in the Registration Statement and the Prospectus, the Company and its Subsidiaries are subsidiaries are, and within the past three (3) years have been, in compliance with all applicable Health Care Laws, except for to the extent that any noncompliance that non-compliance would not not, individually or in the aggregate, reasonably be expected to have a Material Adverse Change. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Public Health Information (the “Privacy Rule”), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, the Health Information Technology for Economic and Clinical Health Service Act (42 U.S.C. Section 17921 201 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; (iiiii) analogous licensure, quality, safety and accreditation requirements under applicable federal, state, local local, supranational or foreign laws or regulatory bodies; and (iviii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiariessubsidiaries, and (iv) the directives and regulations promulgated by such authorities pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither To the Company’s knowledge, neither the Company nor any of its Subsidiaries subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is nor has any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action been threatened. The To the Company’s knowledge, the Company and its Subsidiaries have subsidiaries have, within the past three (3) years, filed, obtained, maintained or submitted all applicable 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 timely, complete, complete and 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 any of its Subsidiaries subsidiaries are a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority. Additionally, neither the Company, its Subsidiaries nor, to the Company’s knowledge, neither the Company, any of its subsidiaries nor any of their respective employees, officers officers, or directors has been are subject to FDA’s application integrity policy or have been, within the past three (3) years, excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is or are subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion. Any certificate signed by any officer or representative of the Company or any of its subsidiaries and delivered to the Agent or counsel for the Agent in connection with an issuance of Shares shall be deemed a representation and warranty by the Company to the Agent as to the matters covered thereby on the date of such certificate. The Company acknowledges that the Agent and, for purposes of the opinions to be delivered pursuant to Section 4(o) hereof, counsel to the Company and counsel to the Agent, will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.

Compliance with Health Care Laws. The Except as described in the Registration Statement, the Disclosure Package and the Prospectus, the Company and its Subsidiaries are subsidiaries are, and at all times have been, in compliance with applicable all Health Care Laws, except for any noncompliance that would not reasonably be expected Laws in all material respects and to have a Material Adverse Changethe extent applicable to the Company’s current business and research use only products. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) (the “FDCA”) and the regulations promulgated thereunder; (ii) 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, 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; (iii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and bodies; (iviii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiariessubsidiaries, and (iv) the regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any of its Subsidiaries have subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its Subsidiaries 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, complete and 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 any of its Subsidiaries are subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority. Additionally, neither the Company, any of its Subsidiaries norsubsidiaries nor any of their respective employees, officers, directors, or, to the Company’s knowledge, any of their respective employeesagents, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Except as described in the Registration Statement and the Prospectus, the Company and its Subsidiaries are in compliance with applicable Health Care Laws, except for any noncompliance that would not reasonably be expected to have a Material Adverse Change. For purposes of this Agreement, “Health Care Laws” meanssubsidiaries: (i) has, since July 1, 2016, operated and currently operates its business in compliance in all material respects with applicable provisions of the Federal FoodHealth Care Laws (as defined below) of the Applicable Regulatory Authorities applicable to the ownership, Drugtesting, and Cosmetic Act and development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any of the regulations promulgated thereunderCompany’s or its subsidiaries’ product candidates or any product manufactured or distributed by the Company or its subsidiaries; (ii) the Standards for Privacy has not, since July 1, 2016, received any FDA Form 483, written notice of Individually Identifiable adverse finding, warning letter, untitled letter or other written correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting material non-compliance with (A) any Health Information Care Laws or (the B) or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Health Care Laws (“Privacy RuleRegulatory Authorizations”), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, 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; (iii) licensure, quality, safety possesses all material Regulatory Authorizations required to conduct its business as currently conducted and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodiessuch Regulatory Authorizations are valid and in full force and effect and neither the Company nor any of its subsidiaries is in material violation of any term of any such Regulatory Authorizations; and (iv) all other localhas not, statesince July 1, federal2016, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiaries. Neither the Company nor its Subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the Applicable Regulatory Authorities or any court or arbitrator or Governmental Entity or other third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to or Regulatory Authorizations and has no knowledge that the Company’s knowledge, Applicable Regulatory Authorities or any other third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (v) has not received written notice that any of the Applicable Regulatory Authorities has taken, hearingis taking or intends to take action to limit, enforcementsuspend, investigation, arbitration substantially modify or other action threatened. The Company revoke any material Regulatory Authorizations and its Subsidiaries have has no knowledge that any of the Applicable Regulatory Authorities is considering such action; (vi) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, Laws or Regulatory Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were timely, complete, accurate materially complete and not misleading correct on the date filed in all material respects (or were materially corrected or supplemented by a subsequent submission). Neither the Company nor its Subsidiaries are ; (vii) is not a party to or have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entity. Additionally, neither the Company, Applicable Regulatory Authority; and (viii) along with its Subsidiaries nor, to the Company’s knowledge, any of their respective employees, officers or directors and directors, has not been excluded, suspended or debarred from participation in any U.S. federal government health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its Subsidiaries are subsidiaries are, and at all times have been, in compliance with applicable all Health Care Laws, except for any noncompliance that would not reasonably be expected Laws in all material respects and to have a Material Adverse Changethe extent applicable to the Company’s current business and investigational product candidates. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”)all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)); (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 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; (iiiiv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (ivvi) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiariessubsidiaries, and (vii) the regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any of its Subsidiaries have subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its Subsidiaries 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, complete and 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 any of its Subsidiaries are subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority. Additionally, neither none of the Company, any of its Subsidiaries nor, to the Company’s knowledge, subsidiaries or any of their respective employees, officers or directors officers, directors, or, to the knowledge of the Company, agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company has operated and its Subsidiaries are currently is in compliance with all applicable Health Care Lawshealth care laws, rules and regulations (except for any noncompliance that where such failure to operate or non-compliance would not reasonably be expected to have not, singly or in the aggregate, result in a Material Adverse Change. For purposes of this AgreementEffect), “Health Care Laws” means: including, without limitation, (i) the Federal Federal, Food, Drug, Drug and Cosmetic Act and the regulations promulgated thereunder; (ii) 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, the Health Information Technology for Economic and Clinical Health Act (42 21 U.S.C. Section 17921 §§ 301 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; (iii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (ivii) all any other local, state, federal, national, supranational and or foreign laws, laws relating to the regulation of the Company or its Subsidiaries(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 nor its Subsidiaries have 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 Entity governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws norLaws, and, to the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company and its Subsidiaries have filed, 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 is 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 agreementsagreement, deferred prosecution agreement, monitoring agreementsagreement, consent decreesdecree, settlement ordersorder, plan of correction or similar agreements with or agreement imposed by any Governmental Entitygovernmental or regulatory authority. Additionally, neither the Company, its Subsidiaries nor, nor to the Company’s knowledge, any of their respective 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, or exclusion.

Compliance with Health Care Laws. The Company and its Subsidiaries are subsidiaries are, and at all times have been, in compliance with applicable all Health Care Laws, except for any noncompliance that would not reasonably be expected Laws in all material respects and to have a Material Adverse Changethe extent applicable to the Company’s current business and research use only products. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”)all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)); (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 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 prescribersAct; (iiiiv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (ivvi) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiariessubsidiaries, and (vii) the regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any of its Subsidiaries have subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its Subsidiaries 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, complete and 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 any of its Subsidiaries are subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority. Additionally, neither the Company, any of its Subsidiaries norsubsidiaries nor any of their respective employees, officers, directors, or, to the Company’s knowledge, any of their respective employeesagents, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The tests, studies, and trials conducted by or on behalf of or sponsored by the Company or any of its Subsidiaries were and, if still pending, are being conducted in all material respects in accordance with all applicable Health Care Laws (as defined below) and standard medical and scientific research protocols, procedures, and controls; none of the Company or any of its Subsidiaries has received any written notice, correspondence, or other written communication from any regulatory agency or any institutional review board or comparable body requiring or threatening the termination, suspension, or material modification of any tests, studies, or trials, or commercial distribution, and to the knowledge of the Company and its Subsidiaries, there are no reasonable grounds for the same. Each of the Company and its Subsidiaries has obtained (or caused to be obtained) the informed consent of each human subject who participated in a test, study, or trial. None of the tests, studies, or trials involved any investigator who has been disqualified as a clinical investigator. The Company and its Subsidiaries are directors, officers, employees, and agents are, and at all times prior hereto have been, in material compliance with with, all health care laws and regulations applicable to the Company or any of its product candidates or activities, including development and testing of pharmaceutical products, kickbacks, recordkeeping, documentation requirements, the hiring of employees (to the extent governed by Health Care Laws), except for quality, safety, privacy, security, licensure, accreditation or any noncompliance that would not reasonably be expected to have a Material Adverse Change. For purposes other aspect of this Agreementdeveloping and testing health care or pharmaceutical products (collectively, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”). The Company has not received any notification, the Security Standardscorrespondence or any other written or oral communication, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, 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; (iii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiaries. Neither the Company nor its Subsidiaries have received written notice including notification of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court governmental authority, including, without limitation, the FDA, the Drug Enforcement Agency, the Centers for Medicare & Medicaid Services, and the U.S. Department of Health and Human Services Office of Inspector General, of potential or arbitrator actual non-compliance by, or Governmental Entity or third party alleging that any product operation or activity is in material violation of liability of, the Company under any Health Care Laws nor, to Laws. To the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration there are no facts or other action threatened. The circumstances that would reasonably be expected to give rise to liability of 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 under any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements except that would not individually or amendments were timely, complete, accurate and not misleading on in the date filed in all material respects (or were corrected or supplemented by aggregate have a subsequent submission). Neither the Company nor its Subsidiaries are a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity. Additionally, neither the Company, its Subsidiaries nor, to the Company’s knowledge, any of their respective employees, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusionMaterial Adverse Effect.

Compliance with Health Care Laws. The Company and its Subsidiaries are in compliance with applicable Health Care Laws, except for any noncompliance that Except as would not reasonably be expected to have a Material Adverse ChangeEffect, the Company and its subsidiaries are, and at all times during the past three (3) years, have been, in compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”21 U.S.C. Section 301 et seq.), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, the Public Health Information Technology for Economic and Clinical Health Service Act (42 U.S.C. Section 17921 201 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 prescribersthereunder; (iiiii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (iviii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiariessubsidiaries; and (iv) the regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither Except as would not reasonably be expected to have a Material Adverse Effect, during the past three (3) years, neither the Company nor any of its Subsidiaries have subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Except as would not reasonably be expected to have a Material Adverse Effect, during the past three (3) years, the Company and its Subsidiaries 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, complete and 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 any of its Subsidiaries are subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority. Additionally, during the past three (3) years, neither the Company, any of its Subsidiaries subsidiaries nor, to the Company’s knowledge, any of their respective employees, officers officers, directors, or directors agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company Each of the Loan Parties is, and at all times during the three (3) calendar years immediately preceding the Closing Date has been, in material compliance with all Health Care Laws. To the knowledge of the Borrowers, no circumstances exist which could reasonably be expected to result in a violation of any Health Care Law. Each of the Loan Parties holds all material Permits for it to own, lease, sublease or operate its Subsidiaries assets, or to conduct its business or operations as presently conducted, and holds all Third Party Payor Authorizations necessary to participate in and be reimbursed by all Third Party Payor Programs in which such Loan Party participates. All such Permits and Third Party Payor Authorizations are in full force and effect and there is no default under, violation of, or other noncompliance with the terms and conditions of any such Permits or any such Third Party Payor Authorizations. Without limiting the generality of any other representation or warranty made herein, (i) each of the pharmacists, pharmacy technicians, physicians, nurses or other licensed personnel, whether employees, independent contractors or leased personnel of each of the Loan Parties (“Licensed Personnel”) holds a valid and unrestricted license to practice his or her profession from each state where he or she is required to be so licensed, and, when required, holds a valid and unrestricted Drug Enforcement Administration registration and applicable state license to prescribe controlled substances, (ii) all Licensed Personnel, in the exercise of their respective duties on behalf of each of the Loan Parties, are in material compliance with all applicable Health Care Laws, and (iii) all agreements between each of the Loan Parties and a hospital or other health care facility and all agreements between each of the Loan Parties and Licensed Personnel are in compliance in all material respects with all applicable Health Care Laws. No Loan Party is subject to any pending, or, to the knowledge of the Borrowers, threatened, investigation, hearing, litigation, suit, proceeding, audit, arbitration, claim review, or other action or communication from any Governmental Entity or Third Party Payor Program of any potential or actual material non-compliance by, or liability of, the Loan Parties under any Health Care Laws, any Permit or any Third Party Payor Authorization. The Parent Borrower has adopted a compliance plan the purpose of which is to assure that each of the Loan Parties and Licensed Personnel are in material compliance with applicable Health Care Laws. None of the Loan Parties, except for any noncompliance that would not reasonably be expected to have a Material Adverse Change. For purposes of this Agreementtheir respective owners, “Health Care Laws” means: (i) the Federal Foodofficers, Drugdirectors, and Cosmetic Act and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”)employees or independent contractors is debarred, the Security Standardssuspended or excluded from participation in any federal health care program, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAAany Third Party Payor Program, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and or any state government procurement or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation procurement program. None of the Company or its Subsidiaries. Neither the Company nor its Subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity or third party alleging that any product operation or activity Loan Parties is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action 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 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 to, or bound by, any corporate integrity agreementsagreement, monitoring agreements, consent decrees, deferred prosecution agreement, settlement ordersagreement, or similar formal or informal agreements with or imposed by any Governmental Entity. Additionally, neither the Company, its Subsidiaries nor, to the Company’s knowledge, any of their respective employees, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusionEntity concerning compliance with Health Care Laws.

Compliance with Health Care Laws. The Company and its Subsidiaries are subsidiaries are, and at all times have been, in compliance with applicable all Health Care Laws, Laws to the extent applicable to the Company; except for any noncompliance such non-compliance that would not reasonably be expected to have singly or in the aggregate result in a Material Adverse Change. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”)all applicable federal, the Security Standardsstate, local and the Standards for Electronic Transactions foreign health care fraud and Code Sets promulgated under HIPAA, 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 prescribersabuse laws; (iiiiv) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (ivv) all other local, state, federal, national, supranational and foreign laws, relating healthcare laws that are applicable to the regulation of the Company or its Subsidiariessubsidiaries. Neither the Company nor any of its Subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity or third party alleging that any product operation or activity subsidiaries is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action 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 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 any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority. Additionally, neither the Company, any of its Subsidiaries norsubsidiaries nor any of their respective employees, officers, directors, or to the Company’s knowledge, any of their respective employees, officers or directors agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, research. Any certificate signed by any officer or representative of the Company or any of its subsidiaries and delivered to the knowledge Agent or counsel for the Agent in connection with an issuance of Shares shall be deemed a representation and warranty by the Company to the Agent as to the matters covered thereby on the date of such certificate. The Company acknowledges that the Agent and, for purposes of the Companyopinions to be delivered pursuant to Section 4(o) hereof, is subject counsel to a governmental inquirythe Company and counsel to the Agent, investigation, proceeding, or other similar action that could reasonably be expected will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to result in debarment, suspension, or exclusionsuch reliance.

Compliance with Health Care Laws. The Company and its Subsidiaries are are, and at all times have been, in compliance with applicable all Health Care Laws, except for any noncompliance that would not reasonably be expected Laws in all material respects and to have a Material Adverse Changethe extent applicable to the Company’s current business and research use only products. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”)all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)); (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 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 prescribersAct; (iiiiv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (ivvi) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiaries, and (vii) the regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any of its Subsidiaries have has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action 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 timely, complete, complete and 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 any of its Subsidiaries are is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority. Additionally, neither the Company, any of its Subsidiaries nornor any of their respective employees, officers, directors, or, to the Company’s knowledge, any of their respective employeesagents, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Except as disclosed in the Registration Statement and the Prospectus, as applicable, the Company and its Subsidiaries are in compliance with applicable Health Care Laws, except for any noncompliance that would not reasonably be expected to have a Material Adverse Change. For purposes of this Agreement, “Health Care Laws” means: (i) in the last five years, has been in compliance in all respects with all applicable statutes, rules and regulations applicable to the testing, development, manufacture, packaging, processing, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, or export of any product manufactured or distributed by the Company including, without limitation the Federal Food, Drug, Drug and Cosmetic Act and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”21 U.S.C. §301 et seq.), the Security Standardsfederal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the Health Insurance Portability and the Standards for Electronic Transactions and Code Sets promulgated under HIPAAAccountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (42 U.S.C. Section 17921 et seq.collectively, “HIPAA”), and 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 thereunder pursuant to such laws, and any comparable state or non-U.S. counterpart thereof or other law or regulation and foreign laws (collectively, the purpose of which is to protect the privacy of individuals or prescribers“Applicable Laws”); (iiiii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiaries. Neither the Company nor its Subsidiaries have has not received any written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity governmental or regulatory authority or third party alleging that or asserting material noncompliance with any product operation Applicable Laws or activity is in material violation of any Health Care licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws nor(“Authorizations”), to the Company’s knowledge, nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The ; (iii) possesses all Authorizations and such Authorizations are valid and in full force and effect in all respects and Company and its Subsidiaries have is not in violation of any term of any such Authorizations; (iv) has not received any written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take, action to limit, suspend, materially modify or revoke any Authorizations nor is any such limitation, suspension, modification or revocation threatened; (v) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, Applicable Laws or Authorizations and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were timely, complete, complete and 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 ; and (vi) is not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity. Additionallygovernmental or regulatory authority, neither except in each of (i), (iii) and (v), where such noncompliance would not, individually or in the Companyaggregate, its Subsidiaries nor, to the Company’s knowledge, any of their respective employees, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusionhave a Material Adverse Effect.

Compliance with Health Care Laws. The Company and its Subsidiaries are subsidiaries are, and at all times have been, in compliance in all material respects with applicable all Health Care LawsLaws (defined below). Neither the Company, except any of its subsidiaries, nor any of their respective officers, directors, employees or agents have engaged in activities which are, as applicable, cause for any noncompliance that would not reasonably be expected to have liability under a Material Adverse Change. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) 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, 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; (iii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its SubsidiariesLaw. Neither the Company nor any of its Subsidiaries have subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company Company, and to the Company’s knowledge, its Subsidiaries subsidiaries have filed, 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, complete and 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 Company, any of its Subsidiaries are subsidiaries, nor, to the Company’s knowledge, any of their respective employees, officers, directors, or agents is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity. Additionally, neither the Company, any of its Subsidiaries nor, to the Company’s knowledge, subsidiaries nor any of their respective employees, officers officers, directors, or directors agents has been excluded, suspended or debarred from participation in any U.S. or Canadian federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its Subsidiaries are are, and at all times have been, in compliance in all material respects with applicable all Health Care LawsLaws (defined below). Neither the Company, except any of its Subsidiaries, nor any of their respective officers, directors, employees or agents have engaged in activities which are, as applicable, cause for any noncompliance that would not reasonably be expected to have liability under a Material Adverse Change. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) 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, 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; (iii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its SubsidiariesLaw. Neither the Company nor any of its Subsidiaries have has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company Company, and to the Company’s knowledge, its Subsidiaries 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, complete and 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 Company, any of its Subsidiaries are Subsidiaries, nor, to the Company’s knowledge, any of their respective employees, officers, directors, or agents is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity. Additionally, neither the Company, any of its Subsidiaries nor, to the Company’s knowledge, nor any of their respective employees, officers officers, directors, or directors agents has been excluded, suspended or debarred from participation in any U.S. or Canadian 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. “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) all applicable federal, state, provincial, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286, 287, 1035, 1347, and 1349 the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the 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 Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, provincial, local or foreign laws or regulatory bodies; and (vi) all other local, state, provincial, federal, national, supranational and foreign laws, relating to the regulation 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. (hh.3) FDA, Health Canada and Other Regulatory Authorities. The Company holds all licenses, certificates, approvals and permits from all United States federal and state and Canadian federal and provincial, foreign and other regulatory authorities, including but not limited to the United States Food and Drug Administration (the “FDA”), and Health Canada (“HC”), and any foreign regulatory authorities performing functions similar to those performed by the FDA, and HC that are material to the conduct of the business of the Company or its Subsidiaries as such business is now conducted as described in the Registration Statement and the Prospectus, all of which are valid and in full force and effect and there is no proceeding pending or, to the knowledge of the Company, threatened which may cause any such license, certificate, approval or permit to be withdrawn, cancelled, suspended or not renewed. Nothing has come to the attention of the Company that has caused the Company to believe that the completed studies, tests, preclinical studies and clinical trials conducted by or on behalf of the Company and its Subsidiaries that are described in the Registration Statement and the Prospectus were not conducted, in all material respects, in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company; or that the drug substances used in the clinical trials have not been manufactured, in all material respects, under “current good manufacturing practices”, when required, in the United States, Canada and other jurisdictions in which such clinical trials have been and are being conducted. No filing or submission to the FDA, HC, or any other regulatory body, that was or is intended to be the basis for any approval of the Company’s products or product candidates, to the knowledge of the Company, contains any material omission or material false information. The Company is not in violation in any material respect, of any material law, order, rule, regulation, writ, injunction or decree of any court or governmental agency or body, applicable to the investigation of new drugs in humans and animals, including, but not limited to, those promulgated by the FDA, or HC.

Compliance with Health Care Laws. The Company and its Subsidiaries subsidiaries are in compliance with applicable Health Care Laws, except for any noncompliance that would not reasonably be expected to have a Material Adverse Change. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) 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, 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; (iii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiaries. Neither the Company nor its Subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity or third party alleging that any product operation or activity is in material violation of any Health Care Laws norand, to the Company’s knowledge, is any such claimits directors, actionofficers, suitemployees, proceeding, hearing, enforcement, investigation, arbitration or other action 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 Lawscontractors, and agents (while acting in such capacity) are and at all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were timely, complete, accurate and not misleading on times during the date filed past three (3) years have been in compliance in all material respects with all health care laws applicable to the Company and its subsidiaries, or any of their products or activities, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)) and other criminal laws applicable to health care fraud, waste, and abuse, the Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), the civil False 11 with respect to scientific data or were corrected information, that (in any such case) at the time such disclosure was made or supplemented failure to disclose occurred, would reasonably be expected to provide a basis for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Policy or for a comparable foreign agency to invoke any similar policy. The Company has not during the last three (3) years (i) received notice that it is subject to any action, citation, suspension, revocation, warning, administrative proceeding or investigation by a subsequent submission). Neither Regulatory Agency that alleges that the Company nor has violated any applicable Health Care Laws or which requires or seeks any adjustment, modification or alteration in the Company’s or any of its Subsidiaries are Subsidiaries’ products or product candidates or in the Company’s or any of its Subsidiaries’ operations, activities, or services that has not been resolved, including any qui tam lawsuits, notice of inspectional observations, FDA warning letter or untitled letter or any similar notices, or (ii) been subject to a party to any corporate integrity agreementsagreement, monitoring agreementsdeferred prosecution agreement, consent decreesdecree, settlement orders, agreement or other similar agreements with or orders mandating or prohibiting future or past activities. As of the date hereof and except as may be disclosed in the Registration Statement and the Prospectus, (i) there are no restrictions imposed by any Governmental EntityRegulatory Agency upon the business, activities or services of the Company that restrict the Company’s business operations, except as would not, individually or in the aggregate, have a Material Adverse Effect, (ii) the Company and its products and product candidates are not, and have not been, otherwise subject to any other enforcement actions taken by the FDA or any other Regulatory Agency, and (iii) to the Company’s knowledge, there are no facts that would reasonably be expected to give rise to such an event as described in the immediately preceding clause (i) or (ii). AdditionallyDuring the past three (3) years, neither none of the Company, its Subsidiaries norsubsidiaries or, to the Company’s knowledge, any of their respective its officers, directors, managers, employees, officers independent contractors or directors other agents has, directly or indirectly, (i) offered to pay to or solicited any remuneration from, in cash, property or in kind, or made any financial arrangements with, any past or present customer, past or present medical director, physician, other health care provider, supplier, contractor, or third-party payor in order to induce or directly or indirectly obtain business or payments from such person, including any item or service for which payment may be made in whole or in part by any third-party payor or for purchasing, leasing, ordering or arranging for or recommending, purchasing, leasing, or ordering any good, facility, service or item for which payment may be made in whole or in part under any federal, State or private health care program; (ii) given or received, or agreed to give or receive, or is aware that there has been excludedmade or that there is any agreement to make or receive, suspended any gift or debarred from participation gratuitous payment or benefit of any kind, nature or description (including in money, property or services) to any U.S. federal past, present or potential patient or customer, medical director, physician, other health care program provider supplier or human clinical research orpotential supplier, contractor, third-party payor or any other person; or (iii) made or agreed to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceedingmake, or other similar action is aware that could reasonably be expected there has been made or that there is any agreement to result in debarmentmake, suspensionany contribution, payment or gift of funds or property to, or exclusion.for the private use of, any person, governmental official, employee or agent where either the contribution, payment or gift or the purpose of such contribution, payment or gift is or was illegal or improper under any

Compliance with Health Care Laws. The Company and its Subsidiaries are and each Person providing services on their behalf (and only in respect to providing services on behalf of the Company and its Subsidiaries) each (i) is, and at all times has been, in compliance in all material respects with all applicable Health Care Laws, except for any noncompliance that would not reasonably be expected to have a Material Adverse Change. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) the Standards for Privacy has not received any written notice from any Person regarding any violation of Individually Identifiable any applicable Health Information (the “Privacy Rule”), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, 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 prescribersCare Law; (iii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiaries. Neither the Company nor its Subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action 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 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 any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, decrees or similar agreements other Legal Proceeding with or imposed by any Governmental Entity; (iv) is not currently excluded, debarred or otherwise ineligible to participate in programs administered by a Governmental Entity, and has not received written notice that (1) any Person providing healthcare services to or on behalf of the Company or its Subsidiaries or (2) any employee or individual contractor of the Company or its Subsidiaries, in either case (1) or (2), is charged with or has been convicted of a criminal offense related to the provision of healthcare items; (v) maintains compliance plans that were created to reasonably assure that (1) any Person providing healthcare services to or on behalf of the Company or its Subsidiaries or (2) any employee or individual contractor of the Company or its Subsidiaries in either case (1) or (2), is in compliance in all material respects with all applicable Health Care Laws and are structured to account for the guidance issued by the U.S. Department of Health and Human Services regarding characteristics of effective corporate compliance programs; (vi) has not knowingly submitted, or caused to be submitted, to any third party payor program any abusive and illegal claim for payment; and (vii) is and always has been, in compliance in all material respects with all written reimbursement policies of all applicable customers and third party payor programs to which the Company or its Subsidiaries is a party, including governmental programs, such as Medicare and Medicaid, and the HIPAA transaction and code set standards. AdditionallyFurther, neither the Company, Company nor any of its Subsidiaries norhave received any written notice of any existing, to the Company’s knowledge, any of their respective employees, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceedingannounced, or other similar action that could anticipated changes in the policies of any applicable third-party payor program which has had, or would reasonably be expected to result in, a material adverse effect on their respective operations. There are no material appeals or audits outstanding with, or any material outstanding overpayments or refunds due to, any third-party payor program. Further, there is no investigation, audit, claim review, or other action pending or threatened, which could result in debarment, a suspension, revocation, termination, restriction, limitation, modification or exclusionnonrenewal of any third-party payor agreement, or result in the exclusion of the Company or any of its Subsidiaries from any third-party payor program.

Compliance with Health Care Laws. The Company Except as described in the Registration Statement and its Subsidiaries are the Prospectus, and except as would not, singly or in compliance with applicable Health Care Lawsthe aggregate, except for any noncompliance that would not have or reasonably be expected to have a Material Adverse Change. For purposes of this Agreement, “Health Care Laws” means: (i) neither the Federal FoodCompany nor its subsidiaries has received any written notice of adverse finding, Drugwarning letter, and Cosmetic Act and untitled letter or other correspondence or notice from the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”)FDA, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, 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 EMA or other law relevant regulatory authorities, or regulation the purpose of which is to protect the privacy of individuals any other court or prescribers; (iii) licensure, quality, safety and accreditation requirements under applicable arbitrator or federal, state, local or foreign laws governmental or regulatory bodies; authority, alleging or asserting material noncompliance with the Federal Food, Drug and Cosmetic Act (iv) all other local21 U.S.C. § 301 et seq.), as amended, and the regulations promulgated thereunder (the “FFDCA”), or similar state, federalfederal or foreign law or regulation (collectively, national, supranational and foreign laws, relating to the regulation of “Health Care Laws”); (ii) the Company or and its Subsidiaries. Neither subsidiaries are and have been in compliance in all material respects with applicable Health Care Laws; (iii) neither the Company nor its Subsidiaries have subsidiaries received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court U.S. or non-U.S. federal, national, state, local or other governmental or regulatory authority, governmental or regulatory agency or body, court, arbitrator or self-regulatory organization (each, a “Governmental Entity Authority”) or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to Laws; (iv) the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its Subsidiaries 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 applicable Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were timely, complete, accurate correct and not misleading on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither ; (v) neither the Company nor its Subsidiaries are subsidiaries or any of their respective directors, officers, employees or agents is or has been debarred, suspended or excluded, or has been convicted of any crime or engaged in any conduct that would result in a debarment, suspension or exclusion from any federal or state government health care program; and (vi) the Company is not a party to and the Company does not have any ongoing reporting obligations pursuant to, any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by an Governmental Authority. Any certificate signed by any Governmental Entity. Additionally, neither officer or representative of the Company, Company or any of its Subsidiaries nor, subsidiaries and delivered to the Company’s knowledge, any Agent or counsel for the Agent in connection with an issuance of their respective employees, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, Shares shall be deemed a representation and warranty by the Company to the knowledge Agent as to the matters covered thereby on the date of such certificate. The Company acknowledges that the Agent and, for purposes of the Companyopinions to be delivered pursuant to Section 4(o) hereof, is subject counsel to a governmental inquirythe Company and counsel to the Agent, investigation, proceeding, or other similar action that could reasonably be expected will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to result in debarment, suspension, or exclusionsuch reliance.

Compliance with Health Care Laws. The Company and its Subsidiaries are subsidiaries are, and at all times have been, in compliance with applicable all Health Care Laws, except for any noncompliance that would not reasonably be expected Laws in all material respects and to have a Material Adverse Changethe extent applicable to the Company’s current business and investigational product candidates. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”)all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)); (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 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; (iiiiv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (ivvi) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiariessubsidiaries, and (vii) the regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any of its Subsidiaries have subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its Subsidiaries 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, complete and 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 any of its Subsidiaries are subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority. Additionally, neither none of the Company, any of its Subsidiaries nor, to the Company’s knowledge, subsidiaries or any of their respective employees, officers or directors officers, directors, or, to the knowledge of the Company, agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its Subsidiaries are subsidiaries are, and at all times have been, in compliance with applicable all Health Care Laws, except for any noncompliance that would not reasonably be expected Laws in all material respects and to have a Material Adverse Changethe extent applicable to the Company’s current business and research use only products. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”)all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)),; (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 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; (iiiiv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (ivvi) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiariessubsidiaries, and (vii) the regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any of its Subsidiaries have subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its Subsidiaries 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, complete and 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 any of its Subsidiaries are subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority. Additionally, neither the Company, any of its Subsidiaries nor, to the Company’s knowledge, subsidiaries nor any of their respective employees, officers or directors officers, directors, or, to the knowledge of the Company, agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and, to the Company’s knowledge, its directors, officers, employees, and its Subsidiaries are agents (while acting in such capacity) are, and at all times prior hereto have been, in compliance with with, all health care laws and regulations applicable Health Care Lawsto the Company or any of its product candidates or activities, except for including development and testing of medical devices, kickbacks, recordkeeping, documentation requirements, the hiring of employees (to the extent governed by health care laws), quality, safety, privacy, security, licensure, accreditation or any noncompliance that would not reasonably be expected to have a Material Adverse Change. For purposes other aspect of this Agreementdeveloping and testing health care or medical device products (collectively, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), except where such noncompliance would not, individually or in the Security Standardsaggregate, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAAhave a Material Adverse Effect. The Company has not received any written notification, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.)correspondence or any other written communication, 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; (iii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiaries. Neither the Company nor its Subsidiaries have received written notice including notification of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court governmental authority, including, without limitation, the United States Food and Drug Administration (“FDA”), the Drug Enforcement Agency (“DEA”), the Centers for Medicare & Medicaid Services, and the U.S. Department of Health and Human Services Office of Inspector General, of potential or arbitrator actual non-compliance by, or Governmental Entity or third party alleging that any product operation or activity is in material violation of liability of, the Company under any Health Care Laws nor, to Laws. To the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration there are no facts or other action threatened. The circumstances that would reasonably be expected to give rise to liability of 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 under any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements except that would not individually or amendments were timely, complete, accurate and not misleading on in the date filed in all material respects (or were corrected or supplemented by aggregate have a subsequent submission)Material Adverse Effect. Neither the Company nor its Subsidiaries are a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity. Additionally, neither the Company, its Subsidiaries nor, to To the Company’s knowledge, the manufacture of Company products by or on behalf of the Company is being conducted in compliance with all Health Care Laws applicable to the Company or any of their its products or activities, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 C.F.R. Part 820 for medical devices or Parts 210-211 for biological products, when sold in the United States, and the respective employeescounterparts thereof promulgated by governmental authorities in countries outside the United States. Except as disclosed in the Registration Statement, officers the Prospectus and any Permitted Free Writing Prospectus (as defined below) or directors as would not reasonably be expected to have a Material Adverse Effect, during the three year period ended on December 31, 2016 and through the date hereof, the Company has been excluded, suspended not had any product or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is Company owned manufacturing site subject to a governmental inquiryauthority (including FDA) shutdown or import or export prohibition, investigationnor received any FDA Form 483 or other governmental authority notice of inspectional observations, proceeding“warning letters,” “untitled letters,” requests to make changes to the Company products, processes or operations, or similar correspondence or notice from the FDA or other similar action that could reasonably be expected governmental authority alleging or asserting material noncompliance with any applicable Health Care Laws. To the Company’s knowledge, neither the FDA nor any other governmental authority has threatened such action. The Company is in compliance in all material respects with all applicable regulatory post-market reporting obligations, including, without limitation, the FDA’s adverse event reporting requirements at 21 CFR Parts 310, 314, 600, and 803, and, to result the extent applicable, the respective counterparts thereof promulgated by governmental authorities in debarment, suspension, or exclusioncountries outside the United States.

Compliance with Health Care Laws. The Company and each of its Subsidiaries are subsidiaries and, to the Company’s knowledge, the directors, officers, employees, and agents (while acting in such capacity) of the Company and each of its subsidiaries are, and at all times since August 1, 2018 have been, in compliance with with, all health care laws and regulations applicable Health Care Lawsto the Company or its subsidiaries, except for any noncompliance that would not reasonably be expected including all such health care laws and regulations pertaining to have a Material Adverse Change. For purposes development and testing of this Agreementhealth care products or medical devices, fraud and abuse, kickbacks, recordkeeping, documentation requirements, the hiring of employees (to the extent governed by health care laws), quality, safety, privacy, security, licensure, ownership, manufacturing, packaging, labeling, processing, use, distribution, storage, import, export, advertising, promotion, marketing or disposal of health care products or medical devices (collectively, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), except where such noncompliance would not, individually or in the Security Standardsaggregate, have a Material Adverse Effect. Except as set forth in the Registration Statement, the Time of Sale Disclosure Package and the Standards for Electronic Transactions and Code Sets promulgated under HIPAAProspectus, 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; (iii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiaries. Neither neither the Company nor any of its Subsidiaries have subsidiaries has received any written notice notification, correspondence or any other written communication for non-compliance of Health Care Laws, including notification of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court Governmental Authority, including, without limitation, the United States Food and Drug Administration (“FDA”), the Centers for Medicare & Medicaid Services, and the U.S. Department of Health and Human Services Office of Inspector General, where such alleged noncompliance would, individually or arbitrator or Governmental Entity or third party alleging that any product operation or activity is in material violation of any Health Care Laws northe aggregate, to have a Material Adverse Effect. To the Company’s knowledge, is there are no facts or circumstances that would reasonably be expected to give rise to liability of the Company or any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and of 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 subsidiaries under any Health Care Laws, except that would not individually or in the aggregate have a Material Adverse Effect Except as set forth in the Registration Statement, the Time of Sale Disclosure Package and all such reportsthe Prospectus, documents, forms, notices, applications, records, claims, submissions the manufacture of products by or on behalf of the Company and supplements or amendments were timely, complete, accurate and not misleading on the date filed its subsidiaries is being conducted in compliance in all material respects (or were corrected or supplemented by a subsequent submission). Neither with all Health Care Laws applicable to the Company or its subsidiaries or any of its products or activities, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 C.F.R. Part 820 for products sold in the United States, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package, the Prospectus and any Permitted Free Writing Prospectus (as defined below) or as would not reasonably be expected to have a Material Adverse Effect, during the three year period ended on December 31, 2019 and through the date hereof, neither Company nor any of its Subsidiaries are subsidiaries has had any product or Company- or subsidiary-owned manufacturing site subject to a party Governmental Authority (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other Governmental Authority notice of inspectional observations, “warning letters,” “untitled letters,” written requests to any corporate integrity agreementsmake changes to the Company products, monitoring agreements, consent decrees, settlement ordersprocesses or operations, or similar agreements written correspondence or notice from the FDA or other Governmental Authority alleging or asserting material noncompliance with or imposed by any Governmental Entityapplicable Health Care Laws that has not been resolved. Additionally, neither the Company, its Subsidiaries nor, to To the Company’s knowledge, neither the FDA nor any of their respective employees, officers or directors other Governmental Authority has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusionthreatened such action.

Compliance with Health Care Laws. The Except as described in the Registration Statement and the Prospectus, the Company and its Subsidiaries are in compliance with applicable Health Care Laws, except for any noncompliance that would not reasonably be expected to have a Material Adverse Change. For purposes of this Agreement, “Health Care Laws” meanssubsidiaries: (i) has, since April 1, 2020, operated and currently operates its business in compliance in all material respects with applicable provisions of the Federal FoodHealth Care Laws (as defined below) of the Applicable Regulatory Authorities applicable to the ownership, Drugtesting, and Cosmetic Act and development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any of the regulations promulgated thereunderCompany’s or its subsidiaries’ product candidates or any product manufactured or distributed by the Company or its subsidiaries; (ii) the Standards for Privacy has not, since April 1, 2020, received any FDA Form 483 that remains unresolved, written notice of Individually Identifiable adverse finding, warning letter, untitled letter or other written correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting material non-compliance with (A) any Health Information Care Laws or (the B) or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Health Care Laws (“Privacy RuleRegulatory Authorizations”), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, 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; (iii) licensure, quality, safety possesses all material Regulatory Authorizations required to conduct its business as currently conducted and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodiessuch Regulatory Authorizations are valid and in full force and effect and neither the Company nor any of its subsidiaries is in material violation of any term of any such Regulatory Authorizations; and (iv) all other localhas not, statesince April 1, federal2020, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiaries. Neither the Company nor its Subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the Applicable Regulatory Authorities or any court or arbitrator or Governmental Entity or other third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to or Regulatory Authorizations and has no knowledge that the Company’s knowledge, Applicable Regulatory Authorities or any other third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (v) has not received written notice that any of the Applicable Regulatory Authorities has taken, hearingis taking or intends to take any material action to limit, enforcementsuspend, investigation, arbitration substantially modify or other action threatened. The Company revoke any material Regulatory Authorizations and its Subsidiaries have has no knowledge that any of the Applicable Regulatory Authorities is considering such action; (vi) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, Laws or Regulatory Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were timely, complete, accurate materially complete and not misleading correct on the date filed in all material respects (or were materially corrected or supplemented by a subsequent submission). Neither the Company nor its Subsidiaries are ; (vii) is not a party to or have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entity. Additionally, neither the Company, Applicable Regulatory Authority; and (viii) along with its Subsidiaries nor, to the Company’s knowledge, any of their respective employees, officers or directors and directors, has not been excluded, suspended or debarred from participation in any U.S. federal government health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company Except as described in the Registration Statement and its Subsidiaries are the Prospectus, the Company: (A) is in material compliance with applicable Health Care Lawsall statutes, except for any noncompliance that would not reasonably be expected to have a Material Adverse Change. For purposes rules or regulations of this Agreement, the U.S. Food and Drug Administration (“Health Care Laws” means: (iFDA”) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) 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, 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; (iii) licensure, quality, safety and accreditation requirements under applicable comparable federal, state, local or foreign laws governmental or regulatory bodiesauthority (“Governmental Authority”) applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”); (B) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”) which would, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change; (C) possesses all material Authorizations necessary for the operation of its business as described in the Registration Statement and the Prospectus and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such Authorizations; and (ivD) all other localsince January 1, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiaries. Neither the Company nor its Subsidiaries have 2016: (i) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any court or arbitrator or Governmental Entity Authority or third party alleging that any product operation or activity is in material violation of any Health Care Applicable Laws nor, to or Authorizations and has no knowledge that the Company’s knowledge, FDA or any Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (ii) has not received notice that the FDA or any Governmental Authority has taken, hearingis taking or intends to take action to limit, enforcementsuspend, investigation, arbitration modify or other action threatened. The Company revoke any material Authorizations and its Subsidiaries have has no knowledge that the FDA or any Governmental Authority is considering such action; and (iii) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were timely, complete, accurate materially complete and not misleading correct 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 any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity. Additionally, neither the Company, its Subsidiaries nor, to the Company’s knowledge, any of their respective employees, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Compliance with Health Care Laws. The Company and its Subsidiaries are in compliance with applicable Health Care Laws, except for any noncompliance that Except as would not reasonably be expected to have a Material Adverse ChangeEffect, the Company and its subsidiaries are, and at all times during the past three (3) years, have been, in compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”21 U.S.C. Section 301 et seq.), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, the Public Health Information Technology for Economic and Clinical Health Service Act (42 U.S.C. Section 17921 201 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 prescribersthereunder; (iiiii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (iviii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiariessubsidiaries; and (iv) the regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither Except as would not reasonably be expected to have a Material Adverse Effect, during the past three (3) years, neither the Company nor any of its Subsidiaries have subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Except as would not reasonably be expected to have a Material Adverse Effect, during the past three (3) years, the Company and its Subsidiaries 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, complete and 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 any of its Subsidiaries are subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entitygovernmental or regulatory authority. Additionally, during the past three (3) years, neither the Company, any of its Subsidiaries subsidiaries nor, to the Company’s knowledge, any of their respective employees, officers officers, directors, or directors agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion. 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 and, to the Company’s knowledge, its directors, officers, employees, and its Subsidiaries are agents (while acting in such capacity) are, and at all times prior hereto have been, in compliance with with, all health care laws and regulations applicable Health Care Lawsto the Company or any of its product candidates or activities, except for including development and testing of medical devices, kickbacks, recordkeeping, documentation requirements, the hiring of employees (to the extent governed by health care laws), quality, safety, privacy, security, licensure, accreditation or any noncompliance that would not reasonably be expected to have a Material Adverse Change. For purposes other aspect of this Agreementdeveloping and testing health care or medical device products (collectively, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), except where such noncompliance would not, individually or in the Security Standardsaggregate, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAAhave a Material Adverse Effect. The Company has not received any written notification, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.)correspondence or any other written communication, 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; (iii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiaries. Neither the Company nor its Subsidiaries have received written notice including notification of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court governmental authority, including, without limitation, the United States Food and Drug Administration (“FDA”), the Drug Enforcement Agency (“DEA”), the Centers for Medicare & Medicaid Services, and the U.S. Department of Health and Human Services Office of Inspector General, of potential or arbitrator actual non-compliance by, or Governmental Entity or third party alleging that any product operation or activity is in material violation of liability of, the Company under any Health Care Laws nor, to Laws. To the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration there are no facts or other action threatened. The circumstances that would reasonably be expected to give rise to liability of 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 under any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements except that would not individually or amendments were timely, complete, accurate and not misleading on in the date filed in all material respects (or were corrected or supplemented by aggregate have a subsequent submission)Material Adverse Effect. Neither the Company nor its Subsidiaries are a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity. Additionally, neither the Company, its Subsidiaries nor, to To the Company’s knowledge, the manufacture of Company products by or on behalf of the Company is being conducted in compliance with all Health Care Laws applicable to the Company or any of their its products or activities, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 C.F.R. Part 820 for medical devices or Parts 210-211 for biological products, when sold in the United States, and the respective employeescounterparts thereof promulgated by governmental authorities in countries outside the United States. Except as disclosed in the Registration Statement, officers and the Prospectus or directors as would not reasonably be expected to have a Material Adverse Effect, during the three year period ended on December 31, 2020 and through the date hereof, the Company has been excluded, suspended not had any product or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is Company owned manufacturing site subject to a governmental inquiryauthority (including FDA) shutdown or import or export prohibition, investigationnor received any FDA Form 483 or other governmental authority notice of inspectional observations, proceeding“warning letters,” “untitled letters,” requests to make changes to the Company products, processes or operations, or similar correspondence or notice from the FDA or other similar action that could reasonably be expected governmental authority alleging or asserting material noncompliance with any applicable Health Care Laws. To the Company’s knowledge, neither the FDA nor any other governmental authority has threatened such action. The Company is in compliance in all material respects with all applicable regulatory post-market reporting obligations, including, without limitation, the FDA’s adverse event reporting requirements at 21 CFR Parts 310, 314, 600, and 803, and, to result the extent applicable, the respective counterparts thereof promulgated by governmental authorities in debarment, suspension, or exclusioncountries outside the United States.