Common use of Compliance with Healthcare Laws Clause in Contracts

Compliance with Healthcare Laws. (a) Without limiting the generality of any other representation or warranty made herein, (i) each of the physicians, nurse practitioners, and physicians assistants, whether employees, independent contractors or leased personnel of each Loan Party (“Licensed Personnel”) holds a valid and unrestricted license to practice his or her profession from each state in which he or she provides professional services, and, when required, holds a valid and unrestricted Drug Enforcement Administration license and applicable state license to prescribe controlled substances, (ii) all Licensed Personnel, in the exercise of their respective duties on behalf of a Loan Party, are in compliance in all material respects with all Healthcare Laws, (iii) all agreements between a Loan Party and a hospital and all agreements between a Loan Party and Licensed Personnel are in compliance in all material respects with all Healthcare Laws and (iv) no Loan Party is and no Licensed Personnel are excluded from participation in any federal or state healthcare program or are listed on the General Services Administration list of excluded parties. To the Borrower’s knowledge, each Loan Party has maintained in all material respects all records required to be maintained by state licensing boards and agencies, CMS, Drug Enforcement Agency and state boards of pharmacy and the federal and/or state healthcare programs as required by the Healthcare Laws and, to the Borrower’s knowledge, there are no presently existing circumstances which would result or likely would result in violations of the Healthcare Laws except such of the foregoing that, individually or in the aggregate, would not have a Material Adverse Effect. Each Loan Party will have, effective as of the Closing Date and at all times thereafter, such Permits, licenses, franchises, certificates and other material approvals or authorizations of governmental or regulatory authorities as are necessary under applicable Requirements of Law to own their respective properties and conduct their respective business (including such Permits as are required under such federal, state and other Healthcare Laws as are applicable thereto), and to receive reimbursement under federal and state healthcare programs. To the Borrower’s knowledge, there currently exist no restrictions, deficiencies, required plans of corrective actions or other such remedial measures with respect to federal and state Medicare and Medicaid Programs’ certifications or licensure, except such of the foregoing that, individually or in the aggregate, would not have a Material Adverse Effect. The Borrower has no knowledge that any condition exists or event has occurred which, in itself or with the giving of notice or lapse of time or both, reasonably would be expected to result in the suspension, revocation, forfeiture, non-renewal of any governmental consent applicable to any Loan Party or Subsidiary of a Loan Party or service Subsidiary of a Loan Party or such Loan Party’s participation in any federal and/or state healthcare program, any other material Third Party Payor Arrangement, or of any participation agreements, which suspension, revocation, forfeiture or non-renewal would have, either individually or in the aggregate, a Material Adverse Effect; provided, however, nothing in the foregoing shall prohibit or prevent any Loan Party from terminating or causing the termination of any contract for the provision of Medical Services in the ordinary course of the Loan Party’s business.

Appears in 7 contracts

Samples: First Lien Credit Agreement (Select Medical Holdings Corp), First Lien Credit Agreement (Select Medical Corp), First Lien Credit Agreement (Select Medical Corp)

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Compliance with Healthcare Laws. (a) Without limiting the generality of any other representation or warranty made herein, (i) each of the physicians, nurse practitioners, and physicians assistants, whether assistants who are employees, independent contractors or leased personnel of each any Loan Party (“Licensed Personnel”) holds a valid and unrestricted license to practice his or her profession from each state in which he or she provides professional servicesservices on behalf of such Loan Party, and, when required, holds a valid and unrestricted Drug Enforcement Administration license and applicable state license to prescribe controlled substances, (ii) all Licensed Personnel, in the exercise of their respective duties on behalf of a Loan Party, are in compliance in all material respects with all Healthcare Laws, (iii) all agreements between a Loan Party and a hospital and all agreements between a Loan Party and Licensed Personnel are in compliance in all material respects with all Healthcare Laws and (iv) no Loan Party is has been and no Licensed Personnel are has been excluded from participation in any federal or state healthcare program or are is listed on the General Services Administration list of excluded parties, except for failures of any of the foregoing that, individually or in the aggregate, would not have a Material Adverse Effect. To the Borrower’s knowledge, each Loan Party has maintained in all material respects all records required to be maintained by state licensing boards and agencies, CMS, Drug Enforcement Agency and state boards of pharmacy and the federal and/or state healthcare programs as required by the Healthcare Laws and, to the Borrower’s knowledge, there are no presently existing circumstances which would result or likely would result in violations of the Healthcare Laws except such of the foregoing that, individually or in the aggregate, would not have a Material Adverse Effect. Each Loan Party will have, effective as of the Closing Date and at all times thereafter, such Permits, licenses, franchises, certificates and other material approvals or authorizations of governmental or regulatory authorities as are necessary under applicable Requirements of Law to own their respective properties and conduct their respective business (including such Permits as are required under such federal, state and other Healthcare Laws as are applicable thereto), and to receive reimbursement under federal and state healthcare programsprograms in which such Loan Party participates, individually or in the aggregate, would not have a Material Adverse Effect. To the Borrower’s knowledge, there currently exist no restrictions, deficiencies, required plans of corrective actions or other such remedial measures with respect to federal and state Medicare and Medicaid Programs’ certifications or licensure, except such of the foregoing that, individually or in the aggregate, would not have a Material Adverse Effect. The Borrower has no knowledge that any condition exists or event has occurred which, in itself or with the giving of notice or lapse of time or both, reasonably would be expected to result in the suspension, revocation, forfeiture, non-renewal of any governmental consent applicable to any Loan Party or Subsidiary of a Loan Party or service Restricted Subsidiary of a Loan Party or such Loan Party’s participation in any federal and/or state healthcare programprogram in which such Loan Party participates, any other material Third Party Payor Arrangement, or of any participation agreementsArrangement in which such Loan Party participates, which suspension, revocation, forfeiture or non-renewal would have, either individually or in the aggregate, a Material Adverse Effect; provided, however, nothing in the foregoing shall prohibit or prevent any Loan Party from terminating or causing the termination of any contract for the provision of Medical Services or participation in any Third Party Payor Arrangement in the ordinary course of the Loan Party’s business.

Appears in 5 contracts

Samples: Credit Agreement (Concentra Group Holdings Parent, Inc.), Credit Agreement (Select Medical Holdings Corp), Credit Agreement (Select Medical Corp)

Compliance with Healthcare Laws. (a) Without limiting the generality of any other representation or warranty made herein, The Company and its subsidiaries: (i) each of the physiciansalong with its employees, nurse practitionersofficers and directors, and physicians assistants, whether employeesto the Company’s knowledge, independent contractors or leased personnel of each Loan Party (“Licensed Personnel”) holds a valid and unrestricted license to practice his or her profession from each state in which he or she provides professional servicesagents, and, when required, holds a valid have complied with and unrestricted Drug Enforcement Administration license and applicable state license to prescribe controlled substances, (ii) all Licensed Personnel, in the exercise of their respective duties on behalf of a Loan Party, are in compliance in all material respects with all Healthcare applicable provisions of the health care laws, including the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq.; the regulations promulgated pursuant to such laws; and any similar federal, state and local laws and regulations of any governmental authority including the Regulatory Agencies applicable to the ownership, testing, development, manufacture, packaging, processing, use, sale, distribution, storage, import, export or disposal of any of the Company’s products or product candidates (collectively the “Health Care Laws”); (ii) have not received any United States Food and Drug Administration Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or governmental or regulatory authority, including any notified body alleging or asserting non-compliance with (A) any Health Care Laws or (B) or any licenses, approvals, clearances, exemptions, CE Certificates of Conformity, permits, registrations, authorizations, and supplements or amendments thereto required by any such Health Care Laws (“Regulatory Authorizations”); (iii) possess all agreements between a Loan Party Regulatory Authorizations required to conduct its business as currently conducted and a hospital such Regulatory Authorizations are valid and all agreements between a Loan Party in full force and Licensed Personnel are effect and the Company is not in compliance violation, in all any material respects with all Healthcare Laws and respect, of any term of any such Regulatory Authorizations; (iv) no Loan Party is have fulfilled and no Licensed Personnel are excluded from participation in any federal or state healthcare program or are listed on performed all of its material obligations with respect to the General Services Administration list of excluded parties. To the Borrower’s knowledge, each Loan Party has maintained in all material respects all records required to be maintained by state licensing boards and agencies, CMS, Drug Enforcement Agency and state boards of pharmacy and the federal and/or state healthcare programs as required by the Healthcare Laws Regulatory Authorizations and, to the BorrowerCompany’s knowledge, there are no presently existing circumstances event has occurred which allows, or after notice or lapse of time would result allow, revocation or likely would result termination thereof or results in violations any other material impairment of the Healthcare Laws except such rights of the foregoing thatholder of any such Regulatory Authorization; (v) have not received written notice of any claim, individually action, suit, proceeding, hearing, enforcement, investigation, arbitration or in the aggregateother action (“Proceeding”) from any governmental authority including any Regulatory Agency or any other third party alleging a material violation of any Health Care Laws or Regulatory Authorizations or limiting, would not have a Material Adverse Effect. Each Loan Party will havesuspending, effective as of the Closing Date and at all times thereaftermodifying, such Permits, licenses, franchises, certificates and other or revoking any material approvals or authorizations of governmental or regulatory authorities as are necessary under applicable Requirements of Law to own their respective properties and conduct their respective business (including such Permits as are required under such federal, state and other Healthcare Laws as are applicable thereto)Regulatory Authorizations, and to receive reimbursement under federal and state healthcare programs. To the Borrower’s knowledge, there currently exist no restrictions, deficiencies, required plans of corrective actions or other such remedial measures with respect to federal and state Medicare and Medicaid Programs’ certifications or licensure, except such of the foregoing that, individually or in the aggregate, would not have a Material Adverse Effect. The Borrower has no knowledge that any condition exists governmental authority including any Regulatory Agencies or event any other third party is considering any Proceeding; (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 or Regulatory Authorizations (“Reports”) and that all such Reports were materially complete and correct on the date filed (or were materially corrected or supplemented by a subsequent submission); (vii) along with its employees, officers and directors, and to the Company’s knowledge, independent contractors and agents, is not a party to or has occurred whichany ongoing reporting obligations pursuant to any corporate integrity agreements, in itself deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with the giving of notice or lapse of time or both, reasonably would be expected to result in the suspension, revocation, forfeiture, non-renewal of imposed by any governmental consent applicable authority including any Regulatory Agencies; and (viii) along with its employees, officers and directors, and to any Loan Party the Company’s knowledge, independent contractors and agents, has not been excluded, suspended or Subsidiary of a Loan Party debarred from, or service Subsidiary of a Loan Party or such Loan Party’s otherwise ineligible for participation in any federal and/or state healthcare program, any other material Third Party Payor Arrangement, government health care program or of any participation agreements, which suspension, revocation, forfeiture or non-renewal would have, either individually or in the aggregate, a Material Adverse Effect; provided, however, nothing in the foregoing shall prohibit or prevent any Loan Party from terminating or causing the termination of any contract for the provision of Medical Services in the ordinary course of the Loan Party’s businesshuman clinical research.

Appears in 3 contracts

Samples: Equity Offeringsm Sales Agreement (DICE Therapeutics, Inc.), Execution Version (DICE Therapeutics, Inc.), Underwriting Agreement (DiCE MOLECULES HOLDINGS, LLC)

Compliance with Healthcare Laws. The Corporation: (aA) Without limiting the generality of any other representation or warranty made herein, (i) each of the physicians, nurse practitioners, is and physicians assistants, whether employees, independent contractors or leased personnel of each Loan Party (“Licensed Personnel”) holds a valid and unrestricted license to practice his or her profession from each state in which he or she provides professional services, and, when required, holds a valid and unrestricted Drug Enforcement Administration license and applicable state license to prescribe controlled substances, (ii) at all Licensed Personnel, in the exercise of their respective duties on behalf of a Loan Party, are times has been in compliance in all material respects with all applicable statutes, rules, regulations, ordinances, orders, by-laws, decrees and guidances applicable to it under any Applicable Laws relating in whole or in part to health and safety and/or the environment, any implementing regulations pursuant to any of the foregoing, and all similar or related federal, state, provincial or local healthcare statutes, regulations and directives applicable to the business of the Corporation, including but not limited to Applicable Laws concerning fee-splitting, kickbacks, corporate practice of medicine, disclosure of ownership, related party requirements, survey, certification, licensing, civil monetary penalties, self-referrals, or laws concerning the privacy and/or security of personal health information and breach notification requirements concerning personal health information (collectively, “Applicable Healthcare Laws”); (B) has not received any correspondence or notice from any Governmental Entity alleging or asserting material noncompliance with any Applicable Healthcare Laws or any Permits required by any such Applicable Healthcare Laws; (C) has not received notice of any pending or threatened claim, suit, proceeding, charge, hearing, enforcement, audit, inspection, investigation, arbitration or other action from any Governmental Entity or third party alleging that any operation or activity of the Corporation, or any of their directors, officers and/or employees is in material violation of any Applicable Healthcare Laws or Permit required by any such Applicable Healthcare Laws, (iii) all agreements between a Loan Party and a hospital and all agreements between a Loan Party and Licensed Personnel are in compliance in all material respects with all Healthcare Laws the Corporation does not have any knowledge or reason to believe that any such Governmental Entity or third party is considering or would have reasonable grounds to consider any such claim, suit, proceeding, charge, hearing, enforcement, audit, inspection, investigation, arbitration or other action; and (ivD) no Loan Party is either directly has, or indirectly on its behalf has, filed, declared, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and no Licensed Personnel are excluded from participation in any federal supplements or state healthcare program or are listed on the General Services Administration list of excluded parties. To the Borrower’s knowledge, each Loan Party has maintained in all material respects all records required to be maintained by state licensing boards and agencies, CMS, Drug Enforcement Agency and state boards of pharmacy and the federal and/or state healthcare programs amendments as required by the any Applicable Healthcare Laws and, to the Borrower’s knowledge, there are no presently existing circumstances which would result or likely would result in violations of the Governmental Entity required by any such Applicable Healthcare Laws in order to keep all Permits in good standing, valid and in full force (except such of where the foregoing thatfailure to so file, declare, obtain, maintain or submit would not, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect. Each Loan Party will have, effective as of Effect on the Closing Date and at all times thereafter, such Permits, licenses, franchises, certificates and other material approvals or authorizations of governmental or regulatory authorities as are necessary under applicable Requirements of Law to own their respective properties and conduct their respective business (including such Permits as are required under such federal, state and other Healthcare Laws as are applicable theretoCorporation), and to receive reimbursement under federal all such reports, documents, forms, notices, applications, records, claims, submissions and state healthcare programs. To supplements or amendments were complete and correct in all material respects on the Borrower’s knowledge, there currently exist no restrictions, deficiencies, required plans of corrective actions date filed (or other such remedial measures with respect to federal and state Medicare and Medicaid Programs’ certifications were corrected or licensure, except such of the foregoing that, individually or in the aggregate, would not have supplemented by a Material Adverse Effect. The Borrower has no knowledge that any condition exists or event has occurred which, in itself or with the giving of notice or lapse of time or both, reasonably would be expected to result in the suspension, revocation, forfeiture, non-renewal of any governmental consent applicable to any Loan Party or Subsidiary of a Loan Party or service Subsidiary of a Loan Party or such Loan Party’s participation in any federal and/or state healthcare program, any other material Third Party Payor Arrangement, or of any participation agreements, which suspension, revocation, forfeiture or non-renewal would have, either individually or in the aggregate, a Material Adverse Effect; provided, however, nothing in the foregoing shall prohibit or prevent any Loan Party from terminating or causing the termination of any contract for the provision of Medical Services in the ordinary course of the Loan Party’s businesssubsequent submission).

Appears in 2 contracts

Samples: Share Exchange Agreement, Planet 13 Holdings Inc.

Compliance with Healthcare Laws. (a) Without limiting In the generality of any other representation or warranty made hereinpast three years, the Company and its subsidiaries (i) each are and at all times have been in material compliance with all statutes, rules or regulations of the physicians, nurse practitioners, U.S. Food and physicians assistants, whether employees, independent contractors or leased personnel of each Loan Party Drug Administration (“Licensed PersonnelFDA) holds a valid ), the U.S. Department of Health and unrestricted license to practice his or her profession from each state in which he or she provides professional servicesHuman Services (“HHS”), and, when required, holds a valid and unrestricted Drug Enforcement Administration license (“DEA”), and other comparable governmental or regulatory authorities and contractual requirements applicable state license to prescribe controlled substancesthe ownership, testing, development, manufacture, packaging, processing (including by sterilizing or irradiating), use, distribution, labeling, storage, import, export or disposal of any article tested, developed, manufactured, packaged, processed or distributed by the Company (collectively, the “Food and Drug Laws”); (ii) all Licensed Personnelhave not received written notice that the FDA, HHS, DEA or any comparable governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any licenses, certificates, approvals, clearances, exemptions, authorizations, permits, registrations and supplements or amendments required by the FDA, HHS, DEA or any comparable governmental or regulatory authority (“Authorizations”) and have no knowledge that the FDA, HHS, DEA or any comparable governmental or regulatory authority is considering such action and have no reason to believe that any such Authorizations will not be renewed in the exercise of their respective duties on behalf of ordinary course, except as would not reasonably be expected to have a Loan Party, are in compliance in all material respects with all Healthcare Laws, Material Adverse Effect; and (iii) all agreements between a Loan Party have not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from FDA, HHS, DEA or any comparable governmental or regulatory authority alleging or asserting noncompliance with applicable statutes, rules and a hospital and all agreements between a Loan Party and Licensed Personnel are in compliance in all material respects with all Healthcare Laws and (iv) no Loan Party is and no Licensed Personnel are excluded from participation in any federal regulations, except for such FDA Form 483s, notices of adverse finding, warning letters, untitled letters or state healthcare program other correspondence or are listed on the General Services Administration list of excluded parties. To the Borrower’s knowledge, each Loan Party has maintained in all material respects all records required to be maintained by state licensing boards and agencies, CMS, Drug Enforcement Agency and state boards of pharmacy and the federal and/or state healthcare programs written notices that have been resolved as required by the Healthcare Laws and, to the Borrower’s knowledge, there are no presently existing circumstances which would result or likely would result in violations of the Healthcare Laws except such of the foregoing that, individually date hereof or in the aggregate, as would not have a Material Adverse Effect. Each Loan Party will haveAdditionally, effective as none of the Closing Date and at all times thereafterCompany, such Permitsits subsidiaries, licenses, franchises, certificates and other material approvals or authorizations of governmental or regulatory authorities as are necessary under applicable Requirements of Law to own their respective properties and conduct their respective business (including such Permits as are required under such federalemployees, state and other Healthcare Laws as are applicable thereto)officers, and directors, or, to receive reimbursement under federal and state healthcare programs. To the BorrowerCompany’s knowledge, there currently exist no restrictionsagents, deficiencieshas been excluded, required plans suspended, debarred or disqualified from participation in any U.S. federal health care program or human clinical research or, to the knowledge of corrective actions the Company or its subsidiaries, is subject to a governmental inquiry, claim, investigation, proceeding, or other such remedial measures with respect to federal and state Medicare and Medicaid Programs’ certifications or licensure, except such of the foregoing that, individually or in the aggregate, similar action that would not have a Material Adverse Effect. The Borrower has no knowledge that any condition exists or event has occurred which, in itself or with the giving of notice or lapse of time or both, reasonably would be expected to result in the any such exclusion, suspension, revocation, forfeiture, non-renewal of any governmental consent applicable to any Loan Party debarment or Subsidiary of a Loan Party disqualification or service Subsidiary of a Loan Party or such Loan Party’s participation has engaged in any federal and/or state healthcare programconduct that would reasonably be expected to result in any such exclusion, any other material Third Party Payor Arrangement, or of any participation agreements, which suspension, revocationdebarment or disqualification. In the past three years, forfeiture or non-renewal would have, either individually or the Company has complied with DEA instructions with respect to the irradiation of cannabis in the aggregateUnited States, a Material Adverse Effect; provided, however, nothing in including cannabis that meets the foregoing shall prohibit or prevent any Loan Party from terminating or causing the termination definition of any contract for the provision of Medical Services in the ordinary course of the Loan Party’s business“marihuana” under 21 U.S.C. § 802(16).

Appears in 1 contract

Samples: Underwriting Agreement (Sotera Health Co)

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Compliance with Healthcare Laws. (a) Without limiting the generality of any other representation or warranty made herein, (i) each of the physicians, nurse practitioners, and physicians assistants, whether employees, independent contractors or leased personnel of each Loan Party (“Licensed Personnel”) holds a valid and unrestricted license to practice his or her profession from each state in which he or she provides professional services, and, when required, holds a valid and unrestricted Drug Enforcement Administration license and applicable state license to prescribe controlled substances, (ii) all Licensed Personnel, in the exercise of their respective duties on behalf of a Loan Party, are in compliance in all material respects with all Healthcare Laws, (iii) all agreements between a Loan Party and a hospital and all agreements between a Loan Party and Licensed Personnel are in compliance in all material respects with all Healthcare Laws and (iv) no Loan Party is and no Licensed Personnel are excluded from participation in any federal or state healthcare program or are listed on the General Services Administration list of excluded parties. To the Borrower’s knowledge, each Loan Party has maintained in all material respects all records required to be maintained by state licensing boards and agencies, CMS, Drug Enforcement Agency and state boards of pharmacy and the federal and/or state healthcare programs as required by the Healthcare Laws and, to the Borrower’s knowledge, there are no presently existing circumstances which would result or likely would result in violations of the Healthcare Laws except such of the foregoing that, individually or in the aggregate, would not have a Material Adverse Effect. Each Loan Party will have, effective as of the Original Closing Date and at all times thereafter, such Permits, licenses, franchises, certificates and other material approvals or authorizations of governmental or regulatory authorities as are necessary under applicable Requirements of Law to own their respective properties and conduct their respective business (including such Permits as are required under such federal, state and other Healthcare Laws as are applicable thereto), and to receive reimbursement under federal and state healthcare programs. To the Borrower’s knowledge, there currently exist no restrictions, deficiencies, required plans of corrective actions or other such remedial measures with respect to federal and state Medicare and Medicaid Programs’ certifications or licensure, except such of the foregoing that, individually or in the aggregate, would not have a Material Adverse Effect. The Borrower has no knowledge that any condition exists or event has occurred which, in itself or with the giving of notice or lapse of time or both, reasonably would be expected to result in the suspension, revocation, forfeiture, non-renewal of any governmental consent applicable to any Loan Party or Subsidiary of a Loan Party or service Subsidiary of a Loan Party or such Loan Party’s participation in any federal and/or state healthcare program, any other material Third Party Payor Arrangement, or of any participation agreements, which suspension, revocation, forfeiture or non-renewal would have, either individually or in the aggregate, a Material Adverse Effect; provided, however, nothing in the foregoing shall prohibit or prevent any Loan Party from terminating or causing the termination of any contract for the provision of Medical Services in the ordinary course of the Loan Party’s business.

Appears in 1 contract

Samples: Term Loan Credit Agreement (Select Medical Holdings Corp)

Compliance with Healthcare Laws. (a) Without limiting In the generality of any other representation or warranty made hereinpast three years, the Company and its subsidiaries (i) each are and at all times have been in material compliance with all statutes, rules or regulations of the physicians, nurse practitioners, U.S. Food and physicians assistants, whether employees, independent contractors or leased personnel of each Loan Party Drug Administration (“Licensed PersonnelFDA) holds a valid ), the U.S. Department of Health and unrestricted license to practice his or her profession from each state in which he or she provides professional servicesHuman Services (“HHS”), and, when required, holds a valid and unrestricted Drug Enforcement Administration license (“DEA”) and other comparable governmental or regulatory authorities and contractual requirements applicable state license to prescribe controlled substancesthe ownership, testing, development, manufacture, packaging, processing (including by sterilizing or irradiating), use, distribution, labeling, storage, import, export or disposal of any article tested, developed, manufactured, packaged, processed or distributed by the Company (collectively, the “Food and Drug Laws”); (ii) all Licensed Personnelhave not received written notice that the FDA, HHS, DEA or any comparable governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any licenses, certificates, approvals, clearances, exemptions, authorizations, permits, registrations and supplements or amendments required by the FDA, HHS, DEA or any comparable governmental or regulatory authority (“Authorizations”) and have no knowledge that the FDA, HHS, DEA or any comparable governmental or regulatory authority is considering such action and have no reason to believe that any such Authorizations will not be renewed in the exercise of their respective duties on behalf of ordinary course, except as would not reasonably be expected to have a Loan Party, are in compliance in all material respects with all Healthcare Laws, Material Adverse Effect; and (iii) all agreements between a Loan Party have not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from FDA, HHS, DEA, or any comparable governmental or regulatory authority alleging or asserting noncompliance with applicable statutes, rules and a hospital and all agreements between a Loan Party and Licensed Personnel are in compliance in all material respects with all Healthcare Laws and (iv) no Loan Party is and no Licensed Personnel are excluded from participation in any federal regulations, except for such FDA Form 483s, notices of adverse finding, warning letters, untitled letters or state healthcare program other correspondence or are listed on the General Services Administration list of excluded parties. To the Borrower’s knowledge, each Loan Party has maintained in all material respects all records required to be maintained by state licensing boards and agencies, CMS, Drug Enforcement Agency and state boards of pharmacy and the federal and/or state healthcare programs written notices that have been resolved as required by the Healthcare Laws and, to the Borrower’s knowledge, there are no presently existing circumstances which would result or likely would result in violations of the Healthcare Laws except such of the foregoing that, individually date hereof or in the aggregate, as would not have a Material Adverse Effect. Each Loan Party will haveAdditionally, effective as none of the Closing Date and at all times thereafterCompany, such Permitsits subsidiaries, licenses, franchises, certificates and other material approvals or authorizations of governmental or regulatory authorities as are necessary under applicable Requirements of Law to own their respective properties and conduct their respective business (including such Permits as are required under such federalemployees, state and other Healthcare Laws as are applicable thereto)officers, and directors, or, to receive reimbursement under federal and state healthcare programs. To the BorrowerCompany’s knowledge, there currently exist no restrictionsagents, deficiencieshas been excluded, required plans suspended, debarred or disqualified from participation in any U.S. federal health care program or human clinical research or, to the knowledge of corrective actions the Company or its subsidiaries, is subject to a governmental inquiry, claim, investigation, proceeding, or other such remedial measures with respect to federal and state Medicare and Medicaid Programs’ certifications or licensure, except such of the foregoing that, individually or in the aggregate, similar action that would not have a Material Adverse Effect. The Borrower has no knowledge that any condition exists or event has occurred which, in itself or with the giving of notice or lapse of time or both, reasonably would be expected to result in the any such exclusion, suspension, revocation, forfeiture, non-renewal of any governmental consent applicable to any Loan Party debarment or Subsidiary of a Loan Party disqualification or service Subsidiary of a Loan Party or such Loan Party’s participation has engaged in any federal and/or state healthcare programconduct that would reasonably be expected to result in any such exclusion, any other material Third Party Payor Arrangement, or of any participation agreements, which suspension, revocationdebarment or disqualification, forfeiture or non-renewal would have, either individually or except in the aggregatecase of the employees of the Company or its subsidiaries, as would not have a Material Adverse Effect; providedmaterial effect on the Company or its subsidiaries. In the past three years, however, nothing the Company has complied with DEA instructions with respect to the irradiation of cannabis in the foregoing shall prohibit or prevent any Loan Party from terminating or causing United States, including cannabis that meets the termination definition of any contract for the provision of Medical Services in the ordinary course of the Loan Party’s business“marihuana” under 21 U.S.C. § 802(16).

Appears in 1 contract

Samples: Underwriting Agreement (Sotera Health Co)

Compliance with Healthcare Laws. (a) Without limiting the generality of any other representation or warranty made hereinThe Company and its Subsidiaries, taken as a whole, (i) each of the physicians, nurse practitioners, and physicians assistants, whether employees, independent contractors or leased personnel of each Loan Party (“Licensed Personnel”) holds a valid and unrestricted license to practice his or her profession from each state in which he or she provides professional services, and, when required, holds a valid and unrestricted Drug Enforcement Administration license and applicable state license to prescribe controlled substances, (ii) all Licensed Personnel, in the exercise of their respective duties on behalf of a Loan Party, are in compliance in all material respects with all Healthcare Lawslegal requirements (including applicable Laws of any Governmental Entity) relating to the provision, administration and/or payment for insurance, insurance-related, and healthcare-related products, services or functions in the conduct of their respective businesses, including, but not limited to (iiiA) all agreements between a Loan Party and a hospital and all agreements between a Loan Party and Licensed Personnel are in compliance in all material respects with all Healthcare Laws and (iv) no Loan Party is and no Licensed Personnel are excluded from participation in any applicable federal or state healthcare program or are listed on the General Services Administration list of excluded parties. To the Borrower’s knowledge, each Loan Party has maintained in all material respects all records required to be maintained by state licensing boards and agencies, CMS, Drug Enforcement Agency and state boards insurance and insurance marketing legal requirements, including applicable Medicare, Medicaid, and CHIP statutory or rule requirements; (B) applicable federal and state health insurance exchange (including Federally-Facilitated Marketplace and State Partnership Marketplace) statutory or rule requirements; (C) the Patient Protection and Affordable Care Act (Pub. L. No. 111-48) and Health Care and Education Reconciliation Act (Pub. L. No. 111-152) and regulations promulgated thereunder (collectively, “Affordable Care Act”) relating to the provision of pharmacy insurance and market exchanges; (D) the federal and/or state healthcare programs Health Insurance Portability and Accountability Act of 1996, as required amended by the Healthcare Laws andHealth Information Technology for Economic and Clinical Health Act, and regulations promulgated thereunder (collectively, “HIPAA”); (E) applicable legal requirements concerning the privacy and/or security of personal data of or concerning an individual (including “protected health information” as that term is defined under HIPAA), including, where applicable, state data breach notification legal requirements, except where the non-compliance with such laws, acts, regulations and other requirements would not, reasonably be expected to the Borrower’s knowledge, there are no presently existing circumstances which would result or likely would result in violations of the Healthcare Laws except such of the foregoing that, individually or in the aggregate, would not have a Material Adverse Effect. Each Loan Party will have, effective as of the Closing Date and at (ii) possess all times thereaftermaterial certificates, such Permitsauthorizations, licenses, franchisespermits, certificates and or other material approvals or authorizations required of governmental or regulatory authorities as are necessary them under applicable Requirements of Law the foregoing laws to own their respective properties and conduct their respective business (including such Permits as are required under such federal, state and other Healthcare Laws as are applicable thereto)businesses, and neither the Company nor any of its Subsidiaries has received any notice of proceedings relating to receive reimbursement under federal and state healthcare programs. To the Borrower’s knowledgerevocation or modification of any such certificate, there currently exist no restrictionsauthorization, deficiencieslicense, required plans permit, or approval which, if the subject of corrective actions an unfavorable decision, ruling or other such remedial measures with respect to federal and state Medicare and Medicaid Programs’ certifications or licensure, except such of the foregoing that, individually or in the aggregatefinding, would not have a Material Adverse Effect. The Borrower has no knowledge that , and (iii) have not received notice from any condition exists governmental or event has occurred whichregulatory authority of potential or actual material non-compliance by, in itself or with liability of, the giving Company or any of notice its Subsidiaries under the foregoing laws, except where doing so would not violate applicable law or lapse of time regulations or both, would not reasonably would be expected to result in the suspension, revocation, forfeiture, non-renewal of any governmental consent applicable to any Loan Party or Subsidiary of a Loan Party or service Subsidiary of a Loan Party or such Loan Party’s participation in any federal and/or state healthcare program, any other material Third Party Payor Arrangement, or of any participation agreements, which suspension, revocation, forfeiture or non-renewal would have, either individually or in the aggregate, have a Material Adverse Effect; provided, however, nothing in the foregoing shall prohibit or prevent any Loan Party from terminating or causing the termination of any contract for the provision of Medical Services in the ordinary course of the Loan Party’s business.

Appears in 1 contract

Samples: Investment Agreement (Connecture Inc)

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