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 (a) Each Credit Party and its each of their respective Subsidiaries are is in compliance with applicable the Health Care LawsLaws applicable to its business, except for any noncompliance that where failure to be in such compliance would not reasonably be expected to have individually or in the aggregate a Material Adverse Change. For purposes Effect. (b) Each Credit Party and each of this Agreement, “Health Care Laws” means: their respective Subsidiaries has (i) the Federal Foodall licenses, Drugconsents, certificates, permits, authorizations, approvals, franchises, registrations, qualifications and other rights from, and Cosmetic Act has made all declarations and filings with, all applicable Governmental Authorities, all self-regulatory authorities and all courts and other tribunals necessary to engage in the regulations promulgated thereunder; business conducted by it (each, an “Authorization”), except for such Authorizations with respect to which the failure to obtain would not reasonably be expected to have individually or in the aggregate a Material Adverse Effect, and (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 no actual knowledge that any product operation Governmental Authority is considering limiting, suspending or activity revoking any such Authorization. All such Authorizations are valid and in full force and effect and each Credit Party and each of their respective Subsidiaries is in material violation compliance with the terms and conditions 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 reportsAuthorizations and with the rules and regulations of the regulatory authorities having jurisdiction with respect to such Authorizations, documents, forms, notices, applications, records, claims, submissions except where failure to be in such compliance or for an Authorization to be valid and supplements in full force and effect would not reasonably be expected to have individually or amendments were timely, complete, accurate and not misleading on in the date filed in all material respects aggregate a Material Adverse Effect. (c) No Credit Party 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 employeesSubsidiaries or any of their respective officers, 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 any Credit Party, employees is or has been threatened in writing to be, (i) excluded from any applicable Federal Health Care Program, (ii) “suspended” or “debarred” from selling products to the CompanyU.S. government or its agencies pursuant to the Federal Acquisition Regulation, is subject relating to a governmental inquiry, investigation, proceedingdebarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other similar applicable laws or regulations; or (iii) made a party to any other action by any Governmental Authority that could would be reasonably likely to prohibit it from selling products to any Federal Health Care Program or other purchaser material to its business pursuant to any federal, state or local laws or regulations. (d) All Products prepared, inspected, maintained, assembled, packaged, repaired, tested, labeled, distributed, managed, sold or marketed by or on behalf of a Credit Party, or any of their respective Subsidiaries have been and are being prepared, inspected, maintained, assembled, packaged, tested, labeled, distributed, managed, sold and marketed in compliance with the Health Care Laws or any other applicable requirement of law, except where failure to be in such compliance would not reasonably be expected to result have individually or in debarment, suspensionthe aggregate a Material Adverse Effect. (e) No Credit Party or any of their respective Subsidiaries has received any written, or exclusionto the knowledge of any Credit Party, oral notice from the FDA or any other Governmental Authority regarding any actual or threatened investigation, inquiry, or administrative or judicial action, hearing, or enforcement proceeding by the FDA or any other Governmental Authority, against the Borrower, any other Credit Party, or any of their respective Subsidiaries regarding any violation of applicable law, including any Health Care Law. No Credit Party or any of their respective Subsidiaries is a party to or has any obligation under any corporate integrity agreement, monitoring agreement, consent decree, settlement agreement or similar agreement related to any Health Care Law imposed by any Governmental Authority.

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 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 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 (a) Without limiting or qualifying Section 6.4 or any other provision of this Agreement, Borrower will comply, and its Subsidiaries are will cause each other Loan Party and each Subsidiary of Borrower to comply, in compliance all material respects with all applicable Health Care LawsLaws relating to the operation of such Person’s business, except for any noncompliance that where failure to comply would not reasonably be expected to have a Material Adverse Change. For purposes of this AgreementEffect. (b) [Reserved]. (c) Borrower will, “Health Care Laws” means: and will cause each other Loan Party and each Subsidiary to: (i) Keep in full force and effect all Authorizations required to operate such Person’s business under applicable Health Care Laws and maintain any other qualifications necessary to conduct, arrange for, administer, provide services in connection with or receive payment for, any clinical research services, except to the Federal Food, Drug, extent such failure to keep in full force and Cosmetic Act and the regulations promulgated thereunder; effect or maintain would not reasonably be expected to have a Material Adverse Effect. (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 Promptly furnish or non-U.S. counterpart thereof or other law or regulation the purpose of which is cause 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 be furnished to the regulation of the Company or its Subsidiaries. Neither the Company nor its Subsidiaries have received written notice of any claimAgent, 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, with respect 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 matters that could reasonably be expected to result in debarmenthave a Material Adverse Effect, suspension(i) copies of all material reports of investigational/inspectional observations issued to and received by the Loan Parties or any of their Subsidiaries, and issued by any Governmental Authority relating to such Person’s business, (ii) copies of all material establishment investigation/inspection reports (including, but not limited to, FDA Form 483’s) issued to and received by Loan Parties or any of their Subsidiaries and issued by any Governmental Authority, and (iii) copies of all material warnings and material untitled letters as well as other material documents received by Loan Parties or any of their Subsidiaries from the FDA, CMS, DEA, or exclusionany other Governmental Authority relating to or arising out of the conduct applicable to the business of the Loan Parties or any of their Subsidiaries that asserts past or ongoing lack of compliance with any Health Care Law or any other applicable foreign, federal, state or local law or regulation of similar import and (iv) notice of any material investigation or material audit or similar proceeding by the FDA, DEA, CMS, or any other Governmental Authority. (iii) Promptly furnish or cause to be furnished to the Agent, with respect to matters that would reasonably be expected to have a Material Adverse Effect, (in such form as may be reasonably required by Agent) copies of all non-privileged, reports, correspondence, pleadings and other communications relating to any matter that could lead to the loss, revocation or suspension (or threatened loss, revocation or suspension) of any material Authorization or of any material qualification of any Loan Party or Subsidiary; provided that any internal reports to a Person’s compliance “hot line” which are promptly investigated and determined to be without merit need not be reported. (iv) Promptly furnish or cause to be furnished to the Agent notice of all material fines or penalties imposed by any Governmental Authority under any Health Care Law against any Loan Party or any of its Subsidiaries. (v) Promptly furnish or cause to be furnished to the Agent notice of all material allegations by any Governmental Authority (or any agent thereof) of fraudulent activities of any Loan Party or any of its Subsidiaries in relation to the provision of clinical research or related services. Notwithstanding anything to the contrary in any Loan Document, no Loan Party or any of its Subsidiaries shall be required to furnish to Agent or any Lender patient-related or other information, the disclosure of which to Agent or such Lender is prohibited by any applicable law.

Compliance with Health Care Laws. The Company and its Subsidiaries are in compliance with applicable Health Care Laws, except Except for any noncompliance matters that would not reasonably be expected to have a Material Adverse Change. For purposes of this Agreementbe, “Health Care Laws” means: (i) individually or in the Federal Foodaggregate, 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 material to the regulation business of the Company or its Subsidiaries. Neither and the Company nor its Subsidiaries have received written notice of any claimSubsidiaries, actiontaken as a whole: (a) Since September 1, suit2019 through the date hereof, proceeding, hearing, enforcement, investigation, arbitration no Company 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 norCompany Subsidiary and, to the Company’s knowledgeKnowledge, no officer or director of the Company or any Company Subsidiary in his or her capacity as such, has entered into or been a party to any Contract (including any settlement agreement, consent decree, deferred prosecution agreement or corporate integrity agreement) with any Governmental Entity relating to any actual or alleged violation of any applicable Health Care Law; (b) No Company or Company Subsidiary and, to the Company’s Knowledge, no officer or director of the Company or any Company Subsidiary in his or her capacity as such, since September 1, 2019 through the date hereof, (i) is or has been subject to any such claimactual or, actionto the Company’s Knowledge, threatened investigation, non-routine audit, sanction, program integrity review, suit, proceedingarbitration, hearing, enforcement, investigation, arbitration mediation or other action threatened. The or proceeding by a Governmental Entity, including in respect of a Government Sponsored Health Care Program, which alleges or asserts that the Company or any Company Subsidiary or any of their respective officers or directors in his or her capacity as such has violated any applicable Heath Care Law, or (ii) has received any written notice, citation, suspension, revocation, limitation, warning, or request for repayment or refund issued by a Governmental Entity, including in respect of a Government Sponsored Health Care Program, which alleges or asserts that the Company or any Company Subsidiary or any officer or director of the Company or any Company Subsidiary in his or her capacity as such has violated any applicable Health Care Law that has not been fully and finally resolved; (c) Since September 1, 2019 through the date hereof, (i) the billing, coding, and claims practices of the Company and its the Company Subsidiaries are, and have filedbeen, obtained, maintained or submitted in compliance in all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any respects with all applicable Health Care Laws, (ii) each Company and Company Subsidiary has timely paid or caused to be paid all known and undisputed refunds, overpayments or adjustments that have become due by the Company or such reportsCompany Subsidiary to a Governmental Entity or Health Care Program, documents(iii) the Company and each Company Subsidiary has implemented and maintained a compliance program, formsincluding policies, noticesprocedures and/or training, applications, records, claims, submissions and supplements or amendments were timely, complete, accurate and not misleading on the date filed intended to ensure compliance in all material respects (or were corrected or supplemented by a subsequent submission). Neither with all applicable Health Care Laws, including billing, coding and claims requirements, and the Company nor its Subsidiaries and each Company Subsidiary is operated in compliance in all material respects with such compliance programs and (iv) to the Company’s Knowledge, as of the date hereof, there are a party no facts or circumstances that would give rise to any corporate integrity agreementsdisallowance, monitoring agreementsrecoupment, consent decreesdenial of payment, settlement orderssuspension of payment, overpayment, or similar agreements penalty action against the Company or any Company Subsidiary, except as accrued for by the Company or any Company Subsidiary in accordance with or imposed by any Governmental Entity. AdditionallyGAAP; (d) Since September 1, 2019 through the date hereof, neither the Company, its Subsidiaries norany Company Subsidiary, nor any director, officer, manager, employee or, to the Company’s knowledgeKnowledge, any contractor or agent thereof in his or her capacity as such, has knowingly and willfully made any untrue statement of their respective employeesfact or fraudulent statement or knowingly and willfully failed to disclose a fact required to be disclosed, officers in each case, to any Governmental Entity, including any such statement that could cause a Governmental Entity to take an enforcement or directors regulatory action in connection with the Company or a Company Subsidiary; (e) (i) to the Company’s Knowledge, each of the employees providing pharmacy or other professional services for or on behalf of the Company or any Company Subsidiary that requires a permit or license holds a valid and unrestricted permit or license to provide such services and is performing only those services for or on behalf of the Company or a Company Subsidiary that are permitted by such permit or license, (ii) the Company or a Company Subsidiary verifies before hire of each such employee and monthly thereafter that all such required permits or licenses held by such employees are valid and unrestricted, and (iii) since September 1, 2019 through the date hereof, to the Company’s Knowledge, no pharmacist has performed professional services that require a license for the Company or a Company Subsidiary during a period when such pharmacist was unlicensed whether as a result of suspicion, revocation, failure to renew or otherwise; (f) (i) Each Company and Company Subsidiary is in compliance in all material respects with the conditions of participation and conditions of payment for provider or supplier agreements or other applicable Contracts for any Health Care Programs in which it participates, (ii) since September 1, 2019 through the date hereof, neither the Company nor any of the Company Subsidiaries is or has been excludedterminated or suspended from participation in or had its billing privileges terminated or suspended by any Health Care Program, suspended and (iii) to the Company’s Knowledge, there is no reason to believe that any such termination or suspension would reasonably be expected to occur; (g) (i) Since September 1, 2019 through the date hereof, no Company or Company Subsidiary or, to the Company’s Knowledge, any director, officer or employee thereof, has been suspended, excluded or debarred from contracting with the federal or any state government or from participating in any Government Sponsored Health Care Program or subject to any action by any Governmental Entity that could result in such suspension, exclusion or debarment, (ii) prior to hire or engagement and periodically thereafter, the Company verifies that no officer, director, manager, employee or other Person providing clinical or medical services to or on behalf of any Company or Company Subsidiary is suspended, excluded or debarred from contracting with the United States federal or any state government or excluded from participation in any U.S. federal health care program or human clinical research orGovernment Sponsored Health Care Program, 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.and

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, 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 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 Except as set forth on Schedule 7.10: (a) Seller possesses all Regulatory Approvals necessary to conduct the Business as presently conducted and such necessary Regulatory Approvals are in full force and effect. No proceeding is pending against Seller or its Affiliates or, to Seller’s Knowledge, threatened, regarding the revocation of any such Regulatory Approval. Except as set forth on Schedule 7.10(a), to Seller’s Knowledge, the use and operation of the Acquired Assets and the operation of the Business are in compliance in all material respects with all applicable Laws, there are no material violations of any such Laws, and neither Seller nor any of its Subsidiaries has received any written notice from the FDA or any other Regulatory Authority alleging any material non-compliance with any Laws applicable to the conduct of the Business. The Seller specifically does not make any representations about the use of any promotional, medical or other marketing materials relating to the Business Product used by Buyer after the Closing, notwithstanding that some or all of any such materials may have been created in whole or in part by Seller prior to the Closing. All such materials are being delivered as part of the Acquired Assets as-is and without any warranty or representation of any kind and Seller shall have no Liability with respect to their use after the Closing. (b) During the two years prior to the Closing Date, with respect to the Business Product, none of Seller or its Affiliates has received or been subject to any: (i) Form 483s, warning letters or other written correspondence from the FDA in which the FDA asserted that the operations of Seller or its Affiliates or other licensees were not in compliance with applicable Health Care LawsLaw; (ii) warning letters or other written correspondence from any other Governmental Authority in which such other Governmental Authority asserted that the operations of Seller, its Affiliates or other licensees were not in compliance with applicable Law; or (iii) investigation, penalty for corrective or remedial action or other compliance or enforcement action initiated by the FDA or any other Governmental Authority. During the two years prior to the Closing Date, except for as set forth on Schedule 7.10(b), there has not been any: (A) occurrence of any noncompliance voluntary or compelled product recall or market withdrawal or replacement conducted by or on behalf of Seller or any other licensee concerning the Business Product; (B) product recall, market withdrawal or replacement conducted by or on behalf of any entity as a result of any alleged defect in the Business Product; or (C) to Seller’s Knowledge, event materially affecting the safety of the Business Product. (c) There are no pending or, to Seller’s Knowledge, threatened in writing actions by the FDA or other Regulatory Authorities which would prohibit or impede the conduct of the Business as currently conducted or contemplated to be conducted in any material respect. Seller has timely filed all forms, applications, statements, reports, data and other information required to be filed with any Regulatory Authority in connection with the conduct of the Business. Seller has not made any material false statements on, or, to Seller’s Knowledge, material omissions from, the applications, approvals, reports and other submissions Seller has made to the FDA or other Regulatory Authorities prepared or maintained to comply with the requirements of the FDA or such other Regulatory Authorities relating to the Business that would not reasonably be expected to have provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Adverse Change. For purposes of this AgreementFacts, “Health Care Bribery, and Illegal Gratuities,” or similar policies, or for any other Regulatory Authority to invoke any similar policies, set forth in any applicable Laws” means. (d) Except as set forth on Schedule 7.10(d), Seller and its Subsidiaries, solely with respect to the Business and the Business Product, as applicable: (ia) are and, during the Federal Foodtwo years prior to the Closing Date, Drughave been in material compliance with all Laws applicable to the ownership, and Cosmetic Act and testing, development, manufacture, packaging, processing, use, distribution, sale, offer for sale, storage, import, export or disposal of the regulations promulgated thereunderProduct Formulation; (iib) the Standards for Privacy have not received any FDA Form 483, notice of Individually Identifiable Health Information (the “Privacy Rule”)adverse finding, the Security Standardswarning letter, 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 untitled letter or other law written correspondence or regulation notice from the purpose of which is to protect FDA or any other Government Entity alleging or asserting material noncompliance with any Laws or any authorizations thereto required by any such Laws in connection with the privacy of individuals or prescribersBusiness; (iiic) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (iv) possess all other local, state, federal, national, supranational and foreign laws, relating to the regulation material authorizations necessary for their conduct of the Company or its Subsidiaries. Neither the Company nor its Subsidiaries Business and Seller is not in material violation of any term of any such authorizations; (d) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration Proceeding pending by the FDA or any other action from any court or arbitrator or Governmental Government Entity or third party alleging that any product Product Formulation, or operation or activity related to any Product Formulation, is in material violation of any Health Care Laws noror authorizations and has no Knowledge that the FDA or any other Government Entity or third party is considering any such Proceeding; (e) have not, during the two years prior to the Company’s knowledgeClosing Date, received written notice that the FDA or any other Government Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company Regulatory Approvals related to the Business; and its Subsidiaries (f) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments with respect to the Business as required by any Health Care Laws, Laws or authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were 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. (e) The preclinical studies and clinical trials with respect to the Business Product conducted by or on behalf of Seller and its Subsidiaries were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Laws and authorizations applicable to such studies and trials. All materials used in such trials materially complied with applicable Governmental Authorization and Laws, and there have not been any material deficiencies or defects in such materials. Solely with respect to the Business Product: (i) the Seller and its Subsidiaries have not received any written notices or correspondence from the FDA or any other Government Entity requiring the termination, suspension or material modification of any preclinical study or clinical trial of a Product Formulation conducted by or on behalf of Seller or its Subsidiaries, and (ii) neither Seller nor any of its Subsidiaries has received any written communication from any Person threatening any claim or lawsuit against Seller or any of its Subsidiaries arising from the administration of a Product Formulation to any Person in the course of any clinical trial conducted by or on behalf of Seller or its Subsidiaries. (f) Except as set forth on Schedule 7.10(f). Neither , with respect to the Company nor Business Product, to Seller’s Knowledge, Seller and its Subsidiaries are a party in material compliance with, and have in place, as applicable, appropriate policies and procedures to ensure material compliance with: (i) all applicable labeling, safety, notification, registration, manufacturing, testing, approval, clearance, transportation, storage, record-keeping, reporting, and all other requirements concerning the Business Products and/or any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, facilities used by Seller 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 employeesits Subsidiaries, officers or directors including under the FDCA, the Federal Trade Commission Act, the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006, and the FDA Amendments Act of 2007, including, but not limited to, the External Analgesic Drug Products for Over-the-Counter Human Use and all other regulations promulgated under each of those Acts. (g) Except as set forth on Schedule 7.10(g), during the two (2) years immediately preceding the Closing, no Business Product has been excludedin material nonconformity with any guaranty provided by the Company pursuant to 21 CFR Part 7, suspended Subpart A, and (ii) as of the Closing Date, no Business Product transferred under this Agreement has been adulterated or debarred from participation in any U.S. federal health care program or human clinical research misbranded by the Company or, to the knowledge Knowledge of the Company, by any other person or entity, pursuant to applicable provisions of the FDCA or any other Health Care Laws, nor is any such product an article which may not, under the provisions of sections 404, 505, 510(k), 512, or 515 of the FDCA, be introduced into interstate commerce, and (iii) as of the date it is placed into interstate commerce by the Company, no Business Product is adulterated or misbranded pursuant to the FDCA or to any other Health Care Laws, nor is any such product an article which may not, under the provisions of sections 404, 505, 510(k), 512, or 515 of the FDCA, be introduced into interstate commerce. (h) Schedule 7.10(h) identifies each material recall of a Business Product or inquiry from a Governmental Authority (whether voluntary or compulsory) in the five (5) years prior to the date of this Agreement. Except as set forth on Schedule 7.10(h), no Business Product developed, formulated, sold, offered for sale, or distributed by Seller or any of its Subsidiaries is currently subject to a governmental inquiryrecall required or requested by any Governmental Authority and, investigationto Seller’s Knowledge, proceeding, there exists no fact or other similar action circumstance that could would reasonably be expected to result in debarmentimpose on Seller or any of its Subsidiaries a duty to recall or withdraw any Business Product or warn any consumer of a product defect. During the five (5) years immediately preceding the Closing, suspensionthe Business Products developed, formulated, sold, offered for sale, or exclusiondistributed by Seller or any of its Subsidiaries were manufactured in accordance with the requirements of 21 CFR Parts 210 and 211 in all material respects. (i) Except as set forth on Schedule 7.10(i), none of Seller or any of its Subsidiaries, nor, to Seller’s Knowledge, any Person acting on behalf of Seller or any of its Subsidiaries, has (i) conducted any clinical trials on any Business Products or (ii) received any written notice that the FDA or any other Governmental Authority or institutional review board has initiated, or threatened to initiate, any clinical hold or other action to suspend any planned clinical trial or otherwise restrict any research or study related to any Business Product. (j) Neither Seller nor, to Seller’s Knowledge, any officer, employee or agent of Seller or any of its Subsidiaries has made any untrue statement of a material fact or fraudulent statement to the FDA or any similar Governmental Authority or failed to disclose a material fact required to be disclosed to the FDA or any similar Governmental Authority with respect to the Business or the Acquired Assets. (k) Without making any representations as to the compliance of the promotional and medical marketing materials relating to the Business with applicable Laws, all Seller promotional and medical marketing materials relating to the Business Product were reviewed by Seller’s medical, legal and regulatory committee, and those materials specifically set forth on Schedule 7.10(k) were submitted to the FDA’s Office of Prescription Drug Promotion prior to first public use. Notwithstanding anything in this Agreement to the contrary, Seller makes no representations and warranties as to the compliance of the promotional and medical marketing materials relating to the Business with applicable Laws.

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 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 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 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 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 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 its Subsidiaries are (a) Each of the Acquired Companies is in compliance in all material respects with all applicable Health Care Laws. All reports, except for any noncompliance that would not reasonably documents, claims, notices, including adverse reaction reporting, required to be expected filed, maintained or furnished to a Governmental Body have been so filed, maintained or furnished in a Material Adverse Change. For purposes of this Agreement, “timely and proper manner in accordance with all applicable Health Care Laws” means: . (ib) 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 None of the Company or its Subsidiaries. Neither the Company nor its Subsidiaries have Acquired Companies has received written notice of any pending or threatened Legal Proceeding, claim, action, suit, proceeding, hearing, enforcement, audit, inquiry, inspection, investigation, arbitration or other action from the U.S. Department of Health and Human Services (“HHS”), the FDA, Health Canada, the Centers for Medicare and Medicaid Services, the HHS Office of Inspector General, the HHS Office for Civil Rights, the U.S. Department of Justice, U.S. Attorney Offices, the Federal Bureau of Investigation, Medicaid Fraud Control Units, State Attorneys General, any court State Medicaid Agency or arbitrator any other applicable Governmental Body, or Governmental Entity or third party any qui tam relator, alleging that any product operation operation, activity or activity product, of any of the Acquired Companies is in material violation of any applicable Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its Subsidiaries have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care LawsLaw, and all no such reportsaction currently exists. None of the Acquired Companies has received any subpoenas or civil investigative demands, 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 is a party to any a corporate integrity agreementsagreement or has any reporting obligations pursuant to a settlement agreement, monitoring agreementsplan of correction or other remedial measure entered into with any Governmental Body. None of the Acquired Companies: (i) has been convicted of any criminal offense relating to the delivery of any item or service under a federal health care program relating to the unlawful manufacture, consent decreesdistribution, settlement ordersprescription or dispensing of a prescription drug or a controlled substance or (ii) paid or has been assessed a civil money penalty under 42 U.S.C. § 1320a-7a or any regulations promulgated thereunder. (c) None of the Acquired Companies, 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 equity holders, officers, directors, managing employees, officers agents or directors contractors has been been, or is currently, excluded, suspended or debarred from participation in Federal Health Care Programs or any U.S. provincial or federal health care program programs in Canada, or human clinical research orbeen excluded, suspended or debarred by any other Governmental Body, nor are any of the foregoing Persons aware of any pending or threatened investigation or government action that may lead to such an exclusion, suspension or debarment. (d) None of the Acquired Companies has in the past or is currently: (i) paying a physician or a physician’s immediate family member any direct or indirect remuneration or submitting claims for any items or services payable by a Federal Health Care Program in violation of the federal Xxxxx law, 42 U.S.C. §1395nn or in violation of any provincial or Canadian federal healthcare programs, or any implementing regulations promulgated thereunder, (ii) knowingly and willfully offering, paying, soliciting or receiving any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind in return for, or to induce, the referral of or the purchase, lease or order, or the arranging for or recommending of the purchase, lease or order, of any good, facility, item or service for which payment may be made in whole or in part under any Federal Health Care Program, or any applicable provincial or Canadian federal health care program, (iii) engaging in the manufacture of any product that would implicate the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), or (iv) engaging in any conduct that would promote patients to switch medications currently prescribed to them. (e) None of the Acquired Companies participate in, is authorized to xxxx or has directly claimed or received reimbursement from any Federal Health Care Program or from any other third party payor program. None of the Acquired Companies provides reimbursement coding or billing advice regarding any items or services payable by Federal Health Care Programs. Each of the Acquired Companies, and each of their products and services, is in compliance with all applicable Medicare and Medicaid requirements including (i) all Medicare managed care requirements including C.F.R. 423.153(d) and rules related to the knowledge Medicare STARS program, and (ii) all quality-based payment programs resulting from the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, in each case to the extent the Acquired Companies are required to comply with such requirements. (f) None of the CompanyAcquired Companies employs or contracts with any physicians, is subject to a governmental inquiry, investigation, proceeding, pharmacists or other similar healthcare professionals to provide professional healthcare services requiring a license or accreditation under any Health Care Law. (g) Each of the Acquired Companies complies with the Clinical Laboratory Improvement Amendments of 1988, as amended, and all Legal Requirements related to point of care testing and pharmacogenetic testing. (h) The Acquired Companies hold all Governmental Authorizations to conduct their respective businesses, including: (i) all Governmental Authorizations required by applicable Health Care Laws to permit any Regulated Activity at a facility, including all controlled drugs and substances licenses, establishment licenses and all corresponding Governmental Authorizations in all jurisdictions the Acquired Companies conduct business; and (ii) all Governmental Authorizations required to market, import, export and sell the Acquired Companies Products, including all drug identification numbers and notices of compliance in Canada and any corresponding Governmental Authorizations in all jurisdictions the Acquired Companies conduct business. All such Governmental Authorizations are valid and in good standing and there is no proceeding pending or threatened which may cause any such Governmental Authorizations to be withdrawn, cancelled, suspended or not renewed. (i) The Acquired Companies have not, nor is there currently under consideration by any of the Acquired Companies or any Governmental Body, initiated any recall (voluntarily or involuntarily initiated), market withdrawal or replacement, field alerts, field corrections, safety alert, warning, “dear doctor” letter, investigator notice or other notice of action related to an alleged lack of safety, efficacy or regulatory compliance of any of the Acquired Companies Products or any other form of product retrieval from the marketplace in respect of any of the Acquired Companies Products or any revocation or suspension of a Governmental Authorization. (j) As of the date hereof, there are no facts or circumstances relating to the business conducted by the Acquired Companies that could would reasonably be expected to result in debarment(a) the recall, suspensionmarket withdrawal or replacement of any product sold or intended to be sold by the Acquired Companies, (b) a change in the marketing classification or exclusiona material change in the labeling of any such products or (c) a termination or suspension of the Governmental Authorizations for such products.

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 in compliance with applicable Health Care Laws, except Except for any noncompliance matters that would not reasonably be expected to have a Material Adverse Change. For purposes of this Agreementbe, “Health Care Laws” means: (i) individually or in the Federal Foodaggregate, 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 material to the regulation business of the Company or its Subsidiaries. Neither and the Company nor its Subsidiaries have received written notice of any claimSubsidiaries, actiontaken as a whole: (a) Since September 1, suit2019 through the date hereof, proceeding, hearing, enforcement, investigation, arbitration no Company 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 norCompany Subsidiary and, to the Company’s knowledgeKnowledge, no officer or director of the Company or any Company Subsidiary in his or her capacity as such, has entered into or been a party to any Contract (including any settlement agreement, consent decree, deferred prosecution agreement or corporate integrity agreement) with any Governmental Entity relating to any actual or alleged violation of any applicable Health Care Law; (b) No Company or Company Subsidiary and, to the Company’s Knowledge, no officer or director of the Company or any Company Subsidiary in his or her capacity as such, since September 1, 2019 through the date hereof, (i) is or has been subject to any such claimactual or, actionto the Company’s Knowledge, threatened investigation, non-routine audit, sanction, program integrity review, suit, proceedingarbitration, hearing, enforcement, investigation, arbitration mediation or other action threatened. The or proceeding by a Governmental Entity, including in respect of a Government Sponsored Health Care Program, which alleges or asserts that the Company or any Company Subsidiary or any of their respective officers or directors in his or her capacity as such has violated any applicable Heath Care Law, or (ii) has received any written notice, citation, suspension, revocation, limitation, warning, or request for repayment or refund issued by a Governmental Entity, including in respect of a Government Sponsored Health Care Program, which alleges or asserts that the Company or any Company Subsidiary or any officer or director of the Company or any Company Subsidiary in his or her capacity as such has violated any applicable Health Care Law that has not been fully and finally resolved; (c) Since September 1, 2019 through the date hereof, (i) the billing, coding, and claims practices of the Company and its the Company Subsidiaries are, and have filedbeen, obtained, maintained or submitted in compliance in all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any respects with all applicable Health Care Laws, (ii) each Company and Company Subsidiary has timely paid or caused to be paid all known and undisputed refunds, overpayments or adjustments that have become due by the Company or such reportsCompany Subsidiary to a Governmental Entity or Health Care Program, documents(iii) the Company and each Company Subsidiary has implemented and maintained a compliance program, formsincluding policies, noticesprocedures and/or training, applications, records, claims, submissions and supplements or amendments were timely, complete, accurate and not misleading on the date filed intended to ensure compliance in all material respects (or were corrected or supplemented by a subsequent submission). Neither with all applicable Health Care Laws, including billing, coding and claims requirements, and the Company nor its Subsidiaries and each Company Subsidiary is operated in compliance in all material respects with such compliance programs and (iv) to the Company’s Knowledge, as of the date hereof, there are a party no facts or circumstances that would give rise to any corporate integrity agreementsdisallowance, monitoring agreementsrecoupment, consent decreesdenial of payment, settlement orderssuspension of payment, overpayment, or similar agreements penalty action against the Company or any Company Subsidiary, except as accrued for by the Company or any Company Subsidiary in accordance with or imposed by any Governmental Entity. AdditionallyGAAP; (d) Since September 1, 2019 through the date hereof, neither the Company, its Subsidiaries norany Company Subsidiary, nor any director, officer, manager, employee or, to the Company’s knowledgeKnowledge, any contractor or agent thereof in his or her capacity as such, has knowingly and willfully made any untrue statement of their respective employeesfact or fraudulent statement or knowingly and willfully failed to disclose a fact required to be disclosed, officers in each case, to any Governmental Entity, including any such statement that could cause a Governmental Entity to take an enforcement or directors regulatory action in connection with the Company or a Company Subsidiary; (e) (i) to the Company’s Knowledge, each of the employees providing pharmacy or other professional services for or on behalf of the Company or any Company Subsidiary that requires a permit or license holds a valid and unrestricted permit or license to provide such services and is performing only those services for or on behalf of the Company or a Company Subsidiary that are permitted by such permit or license, (ii) the Company or a Company Subsidiary verifies before hire of each such employee and monthly thereafter that all such required permits or licenses held by such employees are valid and unrestricted, and (iii) since September 1, 2019 through the date hereof, to the Company’s Knowledge, no pharmacist has performed professional services that require a license for the Company or a Company Subsidiary during a period when such pharmacist was unlicensed whether as a result of suspicion, revocation, failure to renew or otherwise; (f) (i) Each Company and Company Subsidiary is in compliance in all material respects with the conditions of participation and conditions of payment for provider or supplier agreements or other applicable Contracts for any Health Care Programs in which it participates, (ii) since September 1, 2019 through the date hereof, neither the Company nor any of the Company Subsidiaries is or has been excludedterminated or suspended from participation in or had its billing privileges terminated or suspended by any Health Care Program, suspended and (iii) to the Company’s Knowledge, there is no reason to believe that any such termination or suspension would reasonably be expected to occur; (g) (i) Since September 1, 2019 through the date hereof, no Company or Company Subsidiary or, to the Company’s Knowledge, any director, officer or employee thereof, has been suspended, excluded or debarred from contracting with the federal or any state government or from participating in any Government Sponsored Health Care Program or subject to any action by any Governmental Entity that could result in such suspension, exclusion or debarment, (ii) prior to hire or engagement and periodically thereafter, the Company verifies that no officer, director, manager, employee or other Person providing clinical or medical services to or on behalf of any Company or Company Subsidiary is suspended, excluded or debarred from contracting with the United States federal or any state government or excluded from participation in any U.S. Government Sponsored Health Care Program, and (iii) since September 1, 2019 through the date hereof, to the Company’s Knowledge no pharmacist has performed clinical or medical services which require a license for the Company or a Company Subsidiary while suspended, excluded or debarred from contracting with the federal health care program or human clinical research any state government or from participating in any Government Sponsored Health Care Program; and (h) Since September 1, 2019 through the date hereof, no Company or Company Subsidiary or, to the knowledge Company’s Knowledge, any director, officer or employee thereof (i) has been assessed a civil monetary penalty under Section 1128A of the CompanySocial Security Act, (ii) has been convicted of any criminal offense relating to the delivery of any item or service under any Government Sponsored Health Care Program or (iii) is or has been a party to or subject to a governmental inquiry, investigation, proceeding, or other similar any action that could reasonably be expected to result concerning any of the matters described in debarment, suspension, or exclusionthe foregoing clauses (i)–(ii).

Compliance with Health Care Laws. (a) The Company Borrowers and its Subsidiaries their Subsidiaries, when taken as a whole, are in compliance in all material respects with applicable all material Health Care LawsLaws applicable to it, its products and its properties or other assets or its business or operation. Each of Borrowers and their Subsidiaries, taken as a whole, has in effect all material Governmental Authorizations necessary for it to carry on its business and operations, as presently conducted. All such Governmental Authorizations are in full force and effect and there exists no default under, or violation of, any such Governmental Authorization and neither Borrower nor any of their Subsidiaries has received notice or has knowledge that any Governmental Authority is considering limiting, suspending, terminating, adversely amending or revoking any such Governmental Authorization, in each case, except for any noncompliance that where the failure to be in full force and effect, and/or default, or violation or such notice would not reasonably be expected to have a Material Adverse Change. For purposes of this AgreementEffect. (b) Except as set forth on Schedule 4.21, “Health Care Laws” means: (i) the Federal Foodall reports, Drugdocuments, and Cosmetic Act and the regulations promulgated thereunder; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”)claims, 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 notices or non-U.S. counterpart thereof or other law or regulation the purpose of which is approvals required 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 be filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions furnished by the Borrowers and supplements or amendments as required by their Subsidiaries pursuant to any Health Care LawsLaw to any Governmental Authority have been so filed, obtained, maintained or furnished except where the failure to do so would not reasonably be expected to have a Material Adverse Effect, and all such reports, documents, forms, notices, applications, records, claims, submissions claims and supplements or amendments notices were timely, complete, accurate complete and not misleading correct in all material respects on the date filed in all material respects (or were or will be corrected in or supplemented by a subsequent submissionfiling). Neither . (c) Each of 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 norBorrowers and their Subsidiaries, to the Company’s knowledgeextent that it is billing the related payor, any of their has the requisite provider number or other Governmental Authorization to xxxx under Medicare, the respective employeesMedicaid program in the state or states in which such entity operates, officers or directors has been excludedPrivate Third Party Payor Programs (as defined below). There is no investigation, suspended audit, claim review, or debarred from participation in any U.S. federal health care program other action pending, or human clinical research or, threatened to the knowledge of the CompanyBorrowers, is subject to which would result in a governmental inquiryrevocation, investigationsuspension, proceedingtermination, probation, restriction, limitation, or other similar action that could non-renewal of any Governmental Third Party Payor or Private Third Party Payor (as defined below) provider number or result in any of the Borrowers’ or any of their Subsidiaries’ exclusion from any Governmental Third Party Payor Program or Private Third Party Payor Program which individually or in the aggregate, would reasonably be expected to result have a Material Adverse Effect. For purposes of this Agreement, a “Governmental Third Party Payor” means Medicare, Medicaid, TRICARE, state government insurers and any other person or entity which presently or in debarmentthe future maintains Governmental Third Party Payor Programs. In addition, suspensionfor purposes of this Agreement, “Governmental Third Party Payor Programs” means all governmental third party payor programs in which the Borrowers or any of their Subsidiaries participates (including, without limitation, Medicare, Medicaid, TRICARE or any other federal or state health care programs). For purposes of this Agreement, a “Private Third Party Payor” means private insurers and any other person or entity which presently or in the future maintains Private Third Party Payor Programs. In addition, for purposes of this Agreement, “Private Third Party Payor Programs” means all non-governmental third party payor programs in which the Borrowers or any of their Subsidiaries participate (including, without limitation, managed care plans, or exclusionany other private insurance programs).

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 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 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. Except as set forth on SCHEDULE 2.23: (A) All of the Company's and its Subsidiaries' current operations are in compliance with all Health Care Laws (as hereinafter defined), except where any failure to comply would not have a Company Material Adverse Effect. (B) The Company and the Subsidiaries have obtained all material permits, licenses and authorizations required under applicable Health Care Laws and are certified for participation under all Government Programs (as hereinafter defined) from which they seek reimbursement, and the current operations of the Company and its Subsidiaries are in compliance in all material respects with the terms and conditions of any such permits, licenses, authorizations and certifications, in each case. (C) There are no material pending or threatened Health Care Claims against the Company or any Subsidiary. (D) The Company and its Subsidiaries have timely filed substantially all claims and reports required to be filed prior to the date hereof with respect to the Government Programs, all fiscal intermediaries and/or carriers and other private payors, and all such claims and reports are complete and accurate in all material respects and have been prepared in material compliance 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, Laws governing reimbursement 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 threatenedpayment claims. The Company and its Subsidiaries have filedpaid or caused to be paid all known and undisputed refunds, obtainedoverpayments, maintained discounts or submitted all material adjustments which have become due pursuant to such claims and 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 norhave not, to the Company’s 's knowledge, claimed or received reimbursement from any Government Program or any private payor in excess of the amounts permitted by applicable law. (E) No member, stockholder, director, officer, agent or employee of the Company or any of their respective employeesits Subsidiaries is, officers or directors has been to the Company's knowledge, excluded, suspended or debarred from participation participation, or is otherwise ineligible to participate, in any U.S. federal health care program or human clinical research or, to the knowledge of the CompanyGovernment Programs. As used herein, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.the following terms shall have the meanings indicated below:

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 (a) Each Loan Party and its each of their respective Subsidiaries are will comply in compliance 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 Public Health Law and requirements of this Agreement, “Health Care Laws” means: Third Party Payor Arrangements. (b) Each Loan Party and each of their respective Subsidiaries shall (i) the Federal Foodobtain, Drugmaintain and preserve, and Cosmetic Act cause each of its Subsidiaries to obtain, maintain and preserve, and take all necessary action to timely renew, all material Health Care Permits and Registrations (including, as applicable, Health Care Permits necessary for it to be eligible to receive payment and compensation from and to participate in any Third Party Payor Arrangements) which are necessary or useful in the regulations promulgated thereunderproper conduct of its business; (ii) the Standards be and remain in material compliance with all requirements for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), the Security Standardsparticipation in, and for licensure required to provide the Standards for Electronic Transactions goods or services that are reimbursable under, all Government Reimbursement Programs 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 prescribersThird Party Payor Arrangements; (iii) licensurecause all Persons providing professional health care services for or on behalf of any Loan Party (either as an employee or independent contractor) to comply with all applicable Health Care Laws in the performance of their duties, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodiesto maintain in full force and effect all professional licenses and other Health Care Permits required to perform such duties; and (iv) keep and maintain all other local, state, federal, national, supranational and foreign laws, relating records required to the regulation of the Company be maintained by any Governmental Authority 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 otherwise under any Health Care Laws norLaw and Public Health Law. All products designed, developed, investigated, manufactured, prepared, assembled, packaged, tested, labeled, distributed, sold or marketed by or on behalf of any Loan Party or any of their Subsidiaries that are subject to the Company’s knowledgejurisdiction of the FDA shall be designed, is any such claimdeveloped, actioninvestigated, suitmanufactured, proceedingprepared, hearingassembled, enforcementpackaged, investigationtested, arbitration or other action threatened. The Company labeled, distributed, sold and its marketed in compliance with the Public Health Laws. (c) Each Loan Party and each of their respective Subsidiaries have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions shall maintain a corporate and supplements or amendments as required by any health care regulatory compliance program (“RCP”) which addresses the requirements of Health Care Laws, including without limitation HIPAA, and all includes at least the following components: (i) standards of conduct and procedures that describe compliance policies regarding laws with an emphasis on prevention of fraud and abuse; (ii) a specific officer within high-level personnel identified as having overall responsibility for compliance with such reportsstandards and procedures; (iii) training and education programs which effectively communicate the compliance standards and procedures to employees and agents, documents, forms, notices, applications, records, claims, submissions including fraud and supplements abuse laws and illegal billing practices; (iv) auditing and monitoring systems and reasonable steps for achieving compliance with such standards and procedures including publicizing a reporting system to allow employees and other agents to anonymously report criminal or amendments were timely, complete, accurate suspect conduct and not misleading on potential compliance problems; (v) disciplinary guidelines and consistent enforcement of compliance policies including discipline of individuals responsible for the date filed in all material respects failure to detect violations of the RCP; and (or were corrected or supplemented by a subsequent submission)vi) mechanisms to immediately respond to detected violations of the RCP. 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 Each Loan Party and each of their respective employeesSubsidiaries shall modify such RCPs from time to time, officers or directors has been excludedas may be necessary to ensure continuing compliance with all applicable Health Care Laws. Upon request, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, the Lender (and/or its consultants) shall be permitted to review such RCPs. (d) The Loan Parties shall provide to the knowledge Lender upon request, an accurate, complete and current list of all material Government Reimbursement Programs and Third Party Payor Arrangements with respect to the business 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 exclusionLoan Parties.

Compliance with Health Care Laws. (a) The Company operations of each IVonyx Party are, and its Subsidiaries are at all relevant times have been, in compliance in all material respects with applicable Health Care Lawsall Regulations and Court Orders (including, 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”)without limitation, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAAfederal anti-kickback statute, the Health Information Technology for Economic and Clinical Health Xxxxx law, the federal False Claims Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state law prohibiting kickbacks or non-U.S. counterpart thereof certain referrals) relating or applicable to Medicare or any other law state or regulation federal health care programs (collectively, the purpose of which is to protect "Programs") and with -------- 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 Joint Commission on Accreditation of Healthcare Organizations (the "JCAHO"). Except as set forth in Schedule 4.23(a), ----- ---------------- none of the IVonyx Parties is aware of any actual or its Subsidiariesthreatened enforcement action by any Governmental Authorities which have jurisdiction over the operations of any IVonyx Party, including, without limitation, any fines, injunctions, civil or criminal penalties, investigations or suspensions, or by the JCAHO. (b) The IVonyx Parties possess such certificates, authorizations, licenses or permits issued by the appropriate Governmental Authorities, including, without limitation, the United States federal government, as are material to, or legally required for, the operation of the Business. Neither the Company nor its Subsidiaries have No IVonyx Party has received written any notice of any claimproceedings relating to, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Entity or third party alleging otherwise has knowledge that any product operation Governmental Authority is considering, limiting, suspending, modifying or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is revoking any such claimcertificate, actionauthorization, suit, proceeding, hearing, enforcement, investigation, arbitration license or other action threatened. The Company and its Subsidiaries have filed, obtained, maintained or submitted all permit. (c) All material reports, documents, formsclaims and notices required to be filed, noticesmaintained, applications, records, claims, submissions and supplements or amendments as required furnished to any Governmental Authority by any Health Care LawsIVonyx Party have been so filed, and maintained or furnished. Except as set forth in Schedule 4.23(c), all such reports, documents, forms, notices, applications, records, claims, submissions claims and supplements or amendments notices were timely, complete, accurate complete ---------------- and not misleading correct in all material respects on the date filed in all material respects (or were corrected in or supplemented by a subsequent submission). Neither filing) such that no liability exists with respect to such filing. (d) The IVonyx Parties have not, directly or indirectly, paid or delivered any fee, commission or other sum of money or remuneration, however characterized, to any Governmental Authority or any other Person which in any manner is related to any Contract and which is, or may be, with the Company nor its Subsidiaries passage of time, illegal under any Law. (e) None of the IVonyx Parties or any of their respective officers, directors or managing employees have engaged in any activities which are cause for civil penalties or mandatory or permissive exclusion from Medicare or any other Program. (f) The IVonyx Parties meet all requirements of participation and payment of the Programs and other third party payment programs and are a party to valid participation agreements for payment by such Programs and other payment programs. None of the IVonyx Parties has received notice from any corporate integrity agreementsof the Programs or other third party payment programs of any pending or threatened investigations which would result in exclusion or debarment from any of such Programs or other third party payment programs, monitoring agreementsnor does any IVonyx Party have any reason to believe that any such investigations are pending, consent decreesthreatened or imminent. There is no civil, settlement orderscriminal, administrative, or similar agreements with other action, suit, demand, claim, hearing, notice of violation, proceeding, notice or imposed by demand pending, received or threatened against any Governmental Entity. Additionally, neither the Company, IVonyx Party which would reasonably result in its Subsidiaries nor, to the Company’s knowledge, any of their respective employees, officers exclusion or directors has been excluded, suspended or debarred debarment 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, Programs or other similar action third party payment programs. There is no civil or criminal investigation of any IVonyx Party relating in any way to any violation of any Medicare law or regulation. (g) The IVonyx Parties have established and maintain a compliance program to ensure that could reasonably be expected to result in debarment, suspension, or exclusionpatient care services and goods for which the IVonyx Parties have submitted claims for payment are medically necessary services and have been actually provided.

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 Except as set forth in Section 3.18(b) of the Company Disclosure Schedule , and without limiting the generality of any other representation or warranty made by the Company or any Subsidiary herein, the Company and each of its Subsidiaries are is conducting and has conducted its business and operations in compliance with applicable Health Care Lawswith, except for and neither the Company, any noncompliance Subsidiary nor any of their respective officers, managers, directors, employees or shareholders has engaged in any activities that would not reasonably be expected to have constitute a Material Adverse Changeviolation of any applicable Healthcare Law. For purposes Except as set forth in Schedule 3.18(b) of this Agreement, “Health Care Laws” means: the Company Disclosure Schedules: (i) neither the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; Company nor any Subsidiary nor any Company Representative has received any written notice or communication from any Governmental Authority alleging noncompliance with any Healthcare Laws; (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”)there is no civil, 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 criminal 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, administrative action, suit, proceedingdemand, claim, complaint, hearing, enforcement, investigation, arbitration notice, demand letter, warning letter, proceeding or other action from request for information related to noncompliance with, or otherwise involving, any court Healthcare Laws pending against the Company or arbitrator any Subsidiary or Governmental Entity any Company Representative; (iii) neither the Company or third party alleging that any product operation Subsidiary has any material liability (whether actual or activity is in material contingent) for failure to comply with any Healthcare Laws; (iv) there has not been any violation of any Health Care Healthcare 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 or any Subsidiary in their respective submissions or reports 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 entity that could reasonably be expected to result in debarmentan investigation, suspensioncorrective action or enforcement action; (v) the Company and its Subsidiaries have maintained, in all material respects, all records required under any Healthcare Laws; (vi) any remuneration exchanged between the Company or exclusionits Subsidiaries and their customers, suppliers, contractors, consultants or other entities with which they have a business relationship (collectively, “Trading Partners”) has at all times been commercially reasonable, negotiated at arms-length and represents the fair market value for rendered services. (vii) the Company has properly documented, reported and disclosed to its customers and Government Authorities, as applicable, all manufacturer remuneration, including “discounts” or reductions in price (as defined in 42 U.S.C. § 1320a-7b(b)(3)(A)) and administrative fees, as required by any Healthcare Law and contractual requirements of manufacturers and health plans and is otherwise in full compliance with Healthcare Laws (including without limitation the provisions of ERISA) and contractual requirements of manufacturers and health plans regarding such discounts, reductions in price and administrative fees; and (viii) the Company and its Subsidiaries are not relying on any exemption from or deferral of any Health Care Law that would not be available after the Closing. To the Company’s knowledge, there are no pending changes in any Health Care Law that would prevent the Company from conducting the business after the Closing in substantially the same manner as currently conducted.

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 (a) Each of the Company and its Subsidiaries are are, and during the past five (5) years have 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 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 any of its Subsidiaries have during the past five (5) years received any written notice of notification, correspondence or any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action written communication from any court Governmental Authority concerning potential or arbitrator actual non-compliance by, or Governmental Entity or third party alleging that liability of, the Company and any product operation or activity is in of its Subsidiaries under any Health Care Laws and, to the Knowledge of the Company, there are no circumstances reasonably likely to constitute a material violation of any applicable Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its Subsidiaries have filed, 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)Law. Neither the Company nor any of its Subsidiaries are is a party to any corporate integrity agreements, monitoring agreements, deferred or non-prosecution agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental EntityAuthority. (b) Each of the Company and its Subsidiaries holds, and is operating and during the past five (5) years has operated in compliance in all material respects with, all Permits, including Permits of the FDA and any other Governmental Authority under any Health Care Laws, required for the operation of the business, and all such Permits required for the operation of the business as currently conducted are in full force and effect. AdditionallyEach of the Company and its Subsidiaries has fulfilled and performed all of its material obligations with respect to such Permits, and to the Knowledge of the Company, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or result in any other material impairment of the rights of the holder of any Permit. Neither the Company nor any of its Subsidiaries has received any written communication from any Governmental Authority regarding, and, to the Knowledge of the Company, there are no facts or circumstances that are likely to give rise to, (i) any material change in any such Permit, or any failure to materially comply with any applicable Health Care Laws with respect to, or any term or requirement of, any such Permit or (ii) any revocation, withdrawal, suspension, cancellation, limitation, termination or material modification of any such Permit. (c) For the past five (5) years, all applications, notifications, submissions, information, claims, reports and statistics and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for a Permit, including from the FDA or other Governmental Authority under any Health Care Laws, relating to the Company or any of its Subsidiaries, the business, or any products marketed or developed by the Company, when submitted to the FDA or other Governmental Authority were true, complete and correct in all material respects as of the date of submission and any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data have been submitted to the FDA or other Governmental Authority. (d) For the past five (5) years, neither the Company, Company nor any of its Subsidiaries norhas had any manufacturing site subject to a 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” or similar correspondence or written notice from the FDA or other Governmental Authority in respect of the business and alleging or asserting noncompliance with any applicable Health Care Laws or Permits, and to the Knowledge of the Company or any of its Subsidiaries, neither the FDA nor any Governmental Authority is considering such action. (e) Neither the Company nor any of its Subsidiaries is the subject of any pending or, to the Company’s knowledgeKnowledge of the Company or any of its Subsidiaries, threatened investigation in respect of the Company or any of its Subsidiaries or their business or products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. Neither the Company nor any of its Subsidiaries, nor any of their respective employeesofficers, officers directors, employees or directors agents has been excluded, suspended convicted of any crime or debarred from participation engaged in any U.S. federal conduct that could result in a material debarment, suspension or exclusion (i) under 21 U.S.C. Section 335a or any similar Law; or (ii) under any government sponsored or funded health care program or human clinical research or, to the knowledge other third-party payor. As of the Companydate hereof, is subject to a governmental inquiryno claims, investigationactions, proceeding, proceedings or other similar action investigations that could would reasonably be expected to result in such debarment, suspensionsuspension or exclusion are pending or, to the Knowledge of the Company, threatened against the Company or any of its Subsidiaries, or exclusionany of their directors, officers, employees or agents. (f) All preclinical studies and clinical trials in respect of the products that have been or are being conducted by or on behalf of the Company or any of its Subsidiaries are being or have been conducted in compliance in all material respects with applicable Health Care Laws, including, but not limited to, the Federal Food, Drug, and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 812. Neither the Company nor any Subsidiary has received any notices, correspondence or other communication from the FDA or any other Governmental Authority requiring the termination, suspension or material modification of any clinical trials conducted by, or on behalf of, the Company or its Subsidiaries, or in which the Company or any Subsidiary has participated, and to the Knowledge of the Company, there is no reason to believe that the FDA or any other Governmental Authority is considering such action. (g) Section ‎3.18(g) of the Company Disclosure Schedule identifies (i) all recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of any products of the Company (“Safety Notices”); (ii) the dates such Safety Notices, if any, were resolved or closed; and (iii) any material complaints with respect to the Company’s products that are currently unresolved. There have been no material product complaints with respect to the Company’s products that are reasonably likely to result in, and to the Knowledge of the Company, there are otherwise no facts that would be reasonably likely to result in (i) a material Safety Notice with respect to the products, (ii) a change in the marketing classification or a material change in labeling of any of the products, or (iii) a termination or suspension of marketing or testing of any products. (h) None of the Company, its Subsidiaries or any of their respective officers, directors or, to the Knowledge of the Company, employees or agents is or has been: (i) debarred, excluded or suspended from participating in any government healthcare program, (ii) subject to a civil monetary penalty or civil investigative demand, sanctioned or convicted of a crime, or pled nolo contendere or to sufficient facts, in connection with any allegation of violation of any Health Care Law, or (iii) listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs.

Compliance with Health Care Laws. The Company (i) Since January 1, 2013, the Representing Party and its Subsidiaries are have been in compliance in all material respects with applicable all Health Care LawsLaws as applicable, except for any noncompliance that where failures to comply would not not, individually or in the aggregate, reasonably be expected to have a Material Adverse ChangeEffect with respect to the Representing Party. For purposes of this AgreementThe Representing Party and its Subsidiaries have established and implemented written policies, “procedures and/or programs designed to assure that the Representing Party, its Subsidiaries and its directors, officers, employees, agents and personnel are in compliance with all applicable Health Care Laws” means: (i) the Federal Food. Since January 1, Drug2015, all reports, documents, claims, notices, including adverse event reporting, required to be filed, maintained or furnished to a Governmental Entity have been so filed, maintained or furnished in a timely and Cosmetic Act and the regulations promulgated thereunder; proper manner in accordance with all applicable Health Care Laws. (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”)Since January 1, 2013, the Security Standards, Representing Party 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 not received written notice of any pending or threatened legal proceeding, claim, action, suit, proceeding, hearing, enforcement, audit, inquiry, inspection, investigation, arbitration or other action from the U.S. Department of Health and Human Services (“HHS”), the FDA, the Centers for Medicare and Medicaid Services, the HHS Office of Inspector General, the HHS Office for Civil Rights, the U.S. Department of Justice, U.S. Attorney Offices, the Federal Bureau of Investigation, Medicaid Fraud Control Units, State Attorneys General, any court State Medicaid Agency or arbitrator any other applicable Governmental Entity, or Governmental Entity or third party any qui tam relator, alleging that any product operation or activity of the Representing Party or any of its Subsidiaries is in material violation of any applicable Health Care Laws norLaw, to and no such action currently exists. Since January 1, 2013, the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company Representing Party and its Subsidiaries have filednot received any subpoenas or civil investigative demands or similar requests for information, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Lawsare not a party to a corporate integrity agreement, and all such reportsdo not have any reporting obligations pursuant to a settlement agreement, documentsmonitoring agreement, formsconsent decree, notices, applications, records, claims, submissions and supplements order or amendments were timely, complete, accurate and not misleading on other similar agreement or remedial measure entered into with any Governmental Entity that is or would be material to the date filed in all material respects (or were corrected or supplemented by a subsequent submission)Representing Party. Neither the Company Representing Party nor any of its Subsidiaries are a party to nor any corporate integrity agreementsof its directors, monitoring agreementsofficers, consent decreesemployees, settlement ordersagents, or similar agreements with or imposed by any Governmental Entity. Additionally, neither the Company, its Subsidiaries noror, to the Company’s knowledgeKnowledge of the Representing Party, contractors: (i) has been convicted of any criminal offense relating to the marketing or delivery of any item or service under a Federal Health Care Program, or (ii) paid or has been assessed a civil money penalty under 42 U.S.C. § 1320a-7a or any regulations promulgated thereunder. (iii) Neither the Representing Party nor any of their respective its Subsidiaries nor any of its officers, directors, managing employees, officers agents or, to the Representing Party’s Knowledge, contractors has been, or directors has been is currently, excluded, suspended or debarred from participation in Federal Health Care Programs, or been excluded, suspended or debarred by any U.S. federal health care program other Governmental Entity, nor is the Representing Party aware of any pending or human clinical research threatened investigation or government action that may lead to such an exclusion, suspension or debarment. (iv) Neither the Representing Party nor any of its Subsidiaries nor any of its directors, officers, employees, agents or, to the knowledge Knowledge of the CompanyRepresenting Party, is subject any other Person authorized to a governmental inquiryact on the Representing Party’s behalf has knowingly or willfully taken, investigationdirectly or indirectly, proceedingany act in furtherance of an offer, payment, promise to pay, authorization, or ratification of the payment, directly or indirectly, of any gift, money, payment, contribution, or anything of value to any Person to secure any improper advantage or to obtain or retain business that would cause the Representing Party or its Subsidiaries to be in violation of any Health Care Laws. (v) The Representing Party and its Subsidiaries do not participate in, are not authorized to xxxx, and have not directly claimed or received reimbursement from any Federal Health Care Program or from any other similar action third party payor program. The Representing Party and its Subsidiaries do not provide reimbursement coding or billing advice regarding any items or services payable by Federal Health Care Programs. (vi) The Representing Party and its Subsidiaries do not employ any physicians, pharmacists or other health care professionals to provide professional health care services requiring a license or accreditation under any Health Care Laws. (vii) The Representing Party and its Subsidiaries are in material compliance with all applicable Laws with respect to matters relating to patient or individual health care or personal information or data, including, without limitation, HIPAA and any implementing regulations or sub-regulatory guidance promulgated thereto (collectively, “Consumer Privacy Laws”), and maintain information security processes that could (i) include safeguards for the security, confidentiality, and integrity of transactions and confidential or proprietary Representing Party and Subsidiary data or individually identifiable health information used, disclosed, or accessed by the Representing Party or its Subsidiaries, and (ii) are designed to protect against unauthorized access to the Representing Party and Subsidiary IT Systems, Representing Party and Subsidiary data, and the systems of any third Person service providers that have access to Representing Party and Subsidiary data or Representing Party and Subsidiary IT Systems in compliance with applicable requirements of Consumer Privacy Laws. The Representing Party and its Subsidiaries have been in material compliance with all applicable Consumer Privacy Laws. There are no current or, to the Knowledge of the Representing Party, historic facts or circumstances that would reasonably be expected to result in debarment, suspension, give rise to any civil or exclusion.criminal liability or any action by the

Compliance with Health Care Laws. The Company (a) Except as set forth on Schedule 5.27(a): (b) the Company, including the conduct of its business, is and its Subsidiaries are has been at all times during the past three (3) years in compliance with all applicable Health Care Laws, except for any noncompliance that where non-compliance would not reasonably be expected to have a Material Adverse Change. For purposes of this Agreement, “Health Care Laws” means: Effect on the Target Companies taken as a whole; (ic) the Federal Food, DrugCompany holds, 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 operating 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 compliance in all material respects with, all Permits of the FDA and other foreign, federal, state and local regulatory authorities required for the lawful conduct of its business as currently conducted, including, but not limited to, Investigational New Drug Applications (“INDs”); (d) all data, information and representations contained in any submission to, or communications with, the FDA or other foreign regulatory authorities were accurate, truthful and non-misleading in all material respects when submitted or communicated to the FDA or other foreign regulatory authorities (or were corrected in or supplemented by a subsequent submission). Neither submission or communication) and, to 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 Knowledge of the Company, its Subsidiaries remain so currently; (e) no Company clinical study or clinical trial has been terminated or suspended by the FDA or any other applicable Governmental Authority or Institutional Review Board, and neither the FDA nor any other applicable Governmental Authority has commenced or threatened to initiate any clinical hold order on, or otherwise terminate, delay, suspend or materially restrict, any proposed or ongoing clinical study or clinical trial; (f) the Company has to date developed, designed, tested, studied, processed, manufactured, labeled, stored, handled, packaged, imported, exported, and distributed the Company pipeline products and services in compliance in all material respects with all applicable Health Care Laws or other Law. As of the date of this Agreement, the Company has not received, and to the Knowledge of the Company, there is no pending civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, Warning Letter, untitled letter, It Has Come To Our Attention Letter, regulatory communication, proceeding or request for information from the FDA or any Governmental Authority concerning material noncompliance with Health Care Laws or other Law with regard to the Company or Company pipeline products or services; and (g) neither the Company 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 Knowledge of the Company, is subject to a governmental inquiryany of its Affiliates, investigationofficers, proceedingdirectors, or employees has, in the past six (6) years: (i) been debarred, excluded or received notice of action or threat of action with respect to debarment, exclusion or other similar action under the provisions of 21 U.S.C. §§ 335a, 335b, or 335c, 42 U.S.C. § 1320a-7 or any equivalent provisions in any other applicable jurisdiction; (ii) made or offered any payment, gratuity or other thing of value that is prohibited by any Law to personnel of the FDA or any other Governmental Authority; nor (iii) made an untrue statement of a material fact or material fraudulent statement to the FDA or other Governmental Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority, or in any records and documentation prepared or maintained to comply with applicable Laws, or committed any act, made any statement, or failed to make any statement that, at the time of such disclosure in the foregoing in this subsection, could reasonably be expected to result provide a basis for the FDA or any other Governmental Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in debarment56 Fed. Reg. 46191 (September 10, suspension, 1991) or exclusionany similar policy.

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 Company and its Subsidiaries are in compliance with applicable Health Care Laws, except Except for any noncompliance matters that would not reasonably be expected to have be, individually or in the aggregate, material to the business of the Company and the Company Subsidiaries, taken as a Material Adverse Change. For purposes whole: (a) Since September 1, 2019 through the date hereof, no Company or Company 6XEVLGLDU\ DQG WR WKH &RPSDQ\¶V .QRZOHGJH QR Subsidiary in his or her capacity as such, has entered into or been a party to any Contract (including any settlement agreement, consent decree, deferred prosecution agreement or corporate integrity agreement) with any Governmental Entity relating to any actual or alleged violation of this Agreement, “any applicable Health Care Laws” means: Law; (b) 1R &RPSDQ\ RU &RPSDQ\ 6XEVLGLDU\ D no officer or director of the Company or any Company Subsidiary in his or her capacity as such, since September 1, 2019 through the date hereof, (i) is or has been subject to any actual or, WR WKH &RPSD Knowledge, threatened investigation, non-routine audit, sanction, program integrity review, suit, arbitration, mediation or other action or proceeding by a Governmental Entity, including in respect of a Government Sponsored Health Care Program, which alleges or asserts that the Company or any Company Subsidiary or any of their respective officers or directors in his or her capacity as such has violated any applicable Heath Care Law, or (ii) has received any written notice, citation, suspension, revocation, limitation, warning, or request for repayment or refund issued by a Governmental Entity, including in respect of a Government Sponsored Health Care Program, which alleges or asserts that the Company or any Company Subsidiary or any officer or director of the Company or any Company Subsidiary in his or her capacity as such has violated any applicable Health Care Law that has not been fully and finally resolved; (c) Since September 1, 2019 through the date hereof, (i) the Federal Foodbilling, Drugcoding, 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 claims practices of the Company or its Subsidiaries. Neither and the Company nor its Subsidiaries are, and have received written notice of any claimbeen, 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 compliance in all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any respects with all applicable Health Care Laws, (ii) each Company and Company Subsidiary has timely paid or caused to be paid all known and undisputed refunds, overpayments or adjustments that have become due by the Company or such reportsCompany Subsidiary to a Governmental Entity or Health Care Program, documents(iii) the Company and each Company Subsidiary has implemented and maintained a compliance program, formsincluding policies, noticesprocedures and/or training, applications, records, claims, submissions and supplements or amendments were timely, complete, accurate and not misleading on the date filed intended to ensure compliance in all material respects (or were corrected or supplemented by a subsequent submission). Neither with all applicable Health Care Laws, including billing, coding and claims requirements, and the Company nor its Subsidiaries are a party and each Company Subsidiary is operated in compliance in all material respects with such FRPSOLDQFH SURJUDPV DQG XX XR WKH &RPSDQ\¶V circumstances that would give rise to any corporate integrity agreementsdisallowance, monitoring agreementsrecoupment, consent decreesdenial of payment, settlement orderssuspension of payment, overpayment, or similar agreements penalty action against the Company or any Company Subsidiary, except as accrued for by the Company or any Company Subsidiary in accordance with or imposed by any Governmental Entity. AdditionallyGAAP; (d) Since September 1, 2019 through the date hereof, neither the Company, its Subsidiaries norany Company Subsidiary, nor aQ\ GLUHFWRU RIILFHU PDQDJHU HPSOR contractor or agent thereof in his or her capacity as such, has knowingly and willfully made any untrue statement of fact or fraudulent statement or knowingly and willfully failed to disclose a fact required to be disclosed, in each case, to any Governmental Entity, including any such statement that could cause a Governmental Entity to take an enforcement or regulatory action in connection with the Company or a Company Subsidiary; (e) (L WR WKH &RPSDQ\¶V .QRZOHGJH H pharmacy or other professional services for or on behalf of the Company or any Company Subsidiary that requires a permit or license holds a valid and unrestricted permit or license to provide such services and is performing only those services for or on behalf of the Company or a Company Subsidiary that are permitted by such permit or license, (ii) the Company or a Company Subsidiary verifies before hire of each such employee and monthly thereafter that all such required permits or licenses held by such employees are valid and unrestricted, and (iii) since September 1, 2019 through the date hereof, to the Company’s knowledge&RPSDQ\¶V .QRZOHGJH QR SKDUPDFLVW KDV eSfoHr xxXe IRUP Company or a Company Subsidiary during a period when such pharmacist was unlicensed whether as a result of suspicion, revocation, failure to renew or otherwise; (f) (i) Each Company and Company Subsidiary is in compliance in all material respects with the conditions of participation and conditions of payment for provider or supplier agreements or other applicable Contracts for any Health Care Programs in which it participates, (ii) since September 1, 2019 through the date hereof, neither the Company nor any of their respective employees, officers the Company Subsidiaries is or directors has been excludedterminated or suspended from participation in or had its billing privileges terminated or suspended by any +HDOWK &DUH 3URJUDP DQG LLL WR WKH &RPucSh DQ\¶ termination or suspension would reasonably be expected to occur; (g) (i) Since September 1, suspended 2019 through the date hereof, no Company or &RPSDQ\ 6XEVLGLDU\ RU WR WKH &RPSDQ\¶V .QRZOHG suspended, excluded or debarred from contracting with the federal or any state government or from participating in any Government Sponsored Health Care Program or subject to any action by any Governmental Entity that could result in such suspension, exclusion or debarment, (ii) prior to hire or engagement and periodically thereafter, the Company verifies that no officer, director, manager, employee or other Person providing clinical or medical services to or on behalf of any Company or Company Subsidiary is suspended, excluded or debarred from contracting with the United States federal or any state government or excluded from participation in any U.S. federal health care program or human clinical research orGovernment Sponsored Health Care Program, 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.and

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 (a) Except as set forth on Part 4.26 of the Company and its Subsidiaries are in compliance with applicable Health Care LawsDisclosure Schedule, except for any noncompliance that as would not reasonably be expected to have have, individually or in the aggregate, a Company Material Adverse Change. For purposes Effect, each of this Agreementthe Company and its Subsidiaries is and, “since January 1, 2015, has been, in compliance with all applicable Health Care Laws” means: . (ib) 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 Except as set forth on Part 4.26 of the Company or its Subsidiaries. Neither Disclosure Schedule, since January 1, 2015, neither the Company nor any of its Subsidiaries have has received written any notice or communication from any Governmental Authority, and there is no pending or, to the Knowledge of any claimthe Company, action, suit, proceeding, hearing, enforcement, investigation, arbitration threatened Proceeding or other action from any court Governmental Authority, of or arbitrator asserting any noncompliance by, or Governmental Entity liability of, the Company or third party alleging that any product operation or activity is in material violation of its Subsidiaries under any Health Care Laws norLaw. (c) None of the Company, its Subsidiaries, or their respective directors, officers, employees and, to the Knowledge of the Company, agents, has been debarred, disqualified, suspended, or excluded from participation in any foreign, federal or state health care program or governmental program or under any Health Care Law. None of the Company, its Subsidiaries, or their respective directors, officers, employees or, to the Company’s knowledge, agents, has been prosecuted or convicted of any crime for which debarment is mandated or authorized under any such claimHealth Care Law. (d) Except as set forth on Part 4.26 of the Company Disclosure Schedule, actionall laboratory facilities owned, suitleased, proceedingor employed by the Company or its Subsidiaries are, hearingto the extent required by Applicable Law, enforcementbeing operated in compliance with the FDA’s current good laboratory practices regulations, investigationthe FDA’s current good manufacturing practices regulations, arbitration the Clinical Laboratory Improvement Amendments of 1988, as amended, and the equivalent applicable requirements of any state or other action threatened. The local law or any foreign jurisdiction. (e) Except as set forth on Part 4.26 of the Company Disclosure Schedule or as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, the clinical trial services performed by the Company and its Subsidiaries have filedsince January 1, obtained2015 been performed in accordance with, maintained or submitted in all material reportsrespects, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required the standards established by any Health Care Laws, the applicable clinical trial protocols, and all any Contract governing the performance of such reportsservices. Except as set forth on Part 4.25 of the Company Disclosure Schedule, documentsthe Company and its Subsidiaries have not received any written notice since January 1, forms2015 claiming that a clinical trial with respect to which the Company or its Subsidiary provided services was closed or suspended, noticesor that the data from any clinical trial will not be accepted by the FDA or similar regulatory authorities in other jurisdictions, applications, records, claims, submissions and supplements as a result of any action or amendments were timely, complete, accurate and not misleading failure to act on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither part of the Company nor or any of its Subsidiaries are a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, in material contravention of the relevant Contract or similar agreements with or imposed by any Governmental Entity. Additionally, neither the Company, Applicable Law. (f) The Company and each of its Subsidiaries norhas since January 1, 2015 obtained and maintained all Institutional Review Board (“IRB”), ethics committee or other required approvals of clinical trials conducted, supervised or monitored by the Company and its Subsidiaries to the extent required by Health Care Law or its customer Contracts and no such IRB, ethics committee or other required approval has ever been suspended or terminated due to acts or omissions of the Company or any of its Subsidiaries. Since January 1, 2015, to the Company’s knowledgeextent the Company and its Subsidiaries conducted, supervised or monitored clinical trials, the Company and its Subsidiaries have operated in accordance with the requirements of, and any of their respective employeeslimitations imposed by, officers the approving IRB 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 exclusionethics committee.

Compliance with Health Care Laws. Except as disclosed in Section 3.20 of the Company Disclosure Letter: (i) The Company is in compliance with all applicable Health Care Laws, except for such non-compliance as would not reasonably be expected to be material to the Company or its Subsidiaries, individually or in the aggregate; (ii) no unresolved written notice, charge or assertion has been received by the Company or, to the Knowledge of the Company, threatened against the Company alleging any violation of or seeking to investigate any of the foregoing; and (iii) all Company products subject to the jurisdiction of the FDA are being developed, manufactured, labeled, stored and tested by or on behalf of the Company in compliance with all applicable requirements under Health Care Laws, except for such non-compliance as would not reasonably be expected to be material to the Company or its Subsidiaries, individually or in the aggregate. (b) The Company and its Subsidiaries are in possession of all material authorizations, approvals, registrations, clearances, consents, qualifications and other rights from, and has made all material declarations, notices, and filings with the FDA and other United States regulatory authorities (“Company Clearances”) that are necessary for the Company to own, lease and operate its properties or to conduct its business as conducts. All such Company Clearances are valid, and in full force and effect, and the Company is in material compliance with the terms of the Company Clearances. The Company has not received any written notice with respect to the operation of the business of the Company from the FDA or any other Governmental Authority regarding (i) any material adverse change in any Company Clearances, or any failure to comply, in all material respects, with any Health Care Laws or any term or requirement of any Company Clearance or (ii) any revocation, withdrawal, suspension, cancellation, limitation, termination or material modification of any Company Clearance. The Company’s products are in material compliance with the requirements of all applicable final or tentative Over-the-Counter (“OTC”) Monographs published by the FDA. The Company has complied with all applicable Health Care LawsLaws in connection with the preparation of and submission to the FDA of each of the NDAs relating to the Company’s new drug products. With respect to each NDA, except the Company has not received any unresolved notice that has, or reasonably should have, led the Company to believe that any of the NDAs is not currently effective. (c) All applications, notifications, submissions, information, claims, reports and statistics and other data, utilized as the basis for or submitted in connection with any noncompliance that would not reasonably be expected and all Company Clearances from the FDA or other Governmental Authority relating to the Company, its business operations, products, and product candidates, when submitted to the FDA or other Governmental Authority were true, complete and correct in all material respects as of the date of submission and any necessary or required updates, changes, corrections or modification to such applications, submissions, information and data have a Material Adverse Changebeen submitted to the FDA or other Governmental Authority. (d) No product or product candidate currently being manufactured, developed, tested, distributed or marketed by the Company has been recalled or withdrawn from market (whether voluntarily or otherwise). For purposes No proceedings (whether completed or pending) seeking the recall, withdrawal, suspension or seizure of this Agreementany such product or product candidate or pre-market approvals or marketing authorizations are pending, “Health Care Laws” means: or to the Knowledge of the Company, threatened, against the Company, nor have any such proceedings been pending at any time. (i) All Company combination products containing an insect repellent include a pesticide end-use product that is registered with the Federal Food, Drug, U.S. Environmental Protection Agency (the “EPA”) Office of Pesticide Programs and Cosmetic Act and all states where the regulations promulgated thereunderproducts are sold; (ii) the Standards for Privacy of Individually Identifiable Health Information (end-use combination product is manufactured in accordance with 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 prescribersEPA registration; (iii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodiesthe facilities where such combination products are manufactured are registered pesticide producing establishments; and (iv) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiaries. Neither maintains all records required under the Company nor its Subsidiaries have received written notice of any claimFederal Insecticide, actionFungicide, suitand Rodenticide Act, 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 Laws7 U.S.C. §§ 136 et seq., and all such reportsapplicable regulations, documentsPesticide Registration Notices, formsand guidance documents of the EPA. (f) The Company is not enrolled as a supplier or provider under Medicare, noticesMedicaid, applications, records, claims, submissions and supplements or amendments were timely, complete, accurate and not misleading on the date filed in all material respects (any other governmental health care program or were corrected third-party payment program 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 participation agreement for payment 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 such governmental 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 exclusionand third-party payment program.

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 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 Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)); (iii) the Standards for Electronic Transactions and Code Sets promulgated health care fraud provisions under HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (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 (provided, however, that Health Care Laws shall not include Privacy Laws). 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 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 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 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 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 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 described in the Registration Statement, the Pricing Prospectus 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) have operated and currently operate their businesses in compliance in all material respects with all applicable Health Care Laws (as defined below) and any other applicable requirements of the Federal Food, Drug, Food and Cosmetic Act and the regulations promulgated thereunder; Drug Administration (ii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy RuleFDA”), the Security Standards, Department of Health and the Standards for Electronic Transactions Human Services (“HHS”) and Code Sets promulgated under HIPAAany comparable foreign or other regulatory authority to which they are subject (collectively, 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“Applicable Regulatory Authorities”) 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 ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal, to the extent applicable, of any of the Company or its Subsidiaries. Neither subsidiaries’ product candidates; (ii) have not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting material non-compliance with (A) any Health Care Laws or (B) or any licenses, certificates, approvals, clearances, exemptions, registrations, authorizations, permits and supplements or amendments thereto required by any such Health Care Laws (“Regulatory Authorizations”); (iii) possess all material Regulatory Authorizations required to conduct its business as currently conducted and such Regulatory Authorizations are valid and in full force and effect and the Company nor its Subsidiaries is not in violation, in any material respect, of any term of any such Regulatory Authorizations; (iv) have not 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 have 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) have 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 materially modify or other action threatened. The Company revoke any material Regulatory Authorizations and its Subsidiaries has no knowledge that any of the Applicable Regulatory Authorities is considering such action; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any 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 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 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 (a) Except as set forth on Part 4.25(a) of the Company and its Subsidiaries are in compliance with applicable Health Care LawsDisclosure Schedule, except for any noncompliance that as would not reasonably be expected to have have, individually or in the aggregate, a Company Material Adverse Change. For purposes Effect, each of this Agreementthe Company and its Subsidiaries is and, “Health Care Laws” meansduring the past three years, has been, in compliance with the terms of its Governmental Authorizations and all Applicable Laws related to health care matters including those laws related to: (i) the regulation of active pharmaceutical and other ingredients, drugs, biological products and devices, including the Federal Food, Drug, and Cosmetic Act Act, as amended, and comparable foreign laws (including as to data integrity, good manufacturing practices, good clinical practices and good laboratory practices), (ii) fraud and abuse, false claims, anti-kickback, and physician self-referral laws, including those that apply to all payors, and (iii) the regulations promulgated thereunder; pursuant to such laws, each as amended from time to time (ii) the Standards for Privacy of Individually Identifiable collectively, “Health Information (the “Privacy RuleCare Laws”). (b) During the past three years, neither the Security StandardsCompany nor any of its Subsidiaries has received any notice, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAAwarning letter, 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 untitled letter or other law regulatory communication from any Governmental Authority of any noncompliance by, or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iii) licensureliability of, 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 under any Health Care Laws norLaw that is still unresolved or that would reasonably be expected to have, to individually or in the Company’s knowledgeaggregate, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threateneda Company Material Adverse Effect. 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 Except 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 set forth on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither Part 4.25(b) of the Company nor its Subsidiaries are a party to any corporate integrity agreementsDisclosure Schedule, monitoring agreementsduring the past three years, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity. Additionally, neither none of the Company, its Subsidiaries norSubsidiaries, nor their respective directors, officers, employees and, to the Knowledge of the Company’s knowledge, any of their respective employeesagents, officers or directors has been excludeddebarred, suspended disqualified, suspended, or debarred excluded from participation in any U.S. foreign, federal or state health care program or human clinical research orgovernmental program or under any Health Care Law. (c) During the past three years, no product or ingredient with which the Company or any Subsidiary has manufactured is under consideration by the Company, any Subsidiary, customers or by any Governmental Authority for, a recall, withdrawal, suspension, seizure or discontinuation, or has been recalled, withdrawn, suspended, seized or discontinued by the Company, any Subsidiary or their respective customers in any part of the world (whether voluntarily or otherwise). No proceedings in any part of the world (whether completed, existing, pending or threatened) seeking the recall, withdrawal, suspension, seizure or discontinuance of any product with which the Company or any Subsidiary works or has worked are pending against the Company or any of the Subsidiaries (or to the knowledge 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 exclusiontheir respective customers).