Compliance with Health Care Laws. Without limiting the generality of any other representation and warranty contained herein: (a) Except as could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, each of Borrower, its Subsidiaries, and their respective officers, directors, employees, agents and contractors (exercising their respective duties on behalf of the Borrower or any of its Subsidiaries) and each hospice that is not a Subsidiary operated by Borrower or a Subsidiary is, and within the last six years has been, in compliance with all relevant Health Care Laws, and, with respect to the civil monetary penalty law (42 U.S.C. § 1320a-7a), none of them has engaged in any conduct that would result in a material violation of any law or regulation for which penalties could be imposed under 42 U.S.C. § 1320a-7a. (b) Except as set forth on Schedule 5.26(b) and except as could not, individually or in the aggregate reasonably be expected to have a Material Adverse Effect, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary has (i) all licenses, consents, certificates, permits, authorizations, approvals, franchises, registrations, certificates of need, accreditations, and other rights from, and has made all declarations and filings with, all applicable Governmental Authorities and accrediting organizations (each, a “Health Care Permit”) necessary to operate its business, and (ii) not received notice and has no knowledge that any Governmental Authority or accreditation organization is considering limiting, suspending, terminating, or revoking any such Health Care Permit. All such Health Care Permits are valid and in full force and effect, except as could not reasonably be expected to have a Material Adverse Effect, and the Borrower and each of its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary is in material compliance with the terms and conditions of all such Health Care Permits and with the rules and regulations of the Governmental Authorities and accrediting organizations having jurisdiction with respect to such Health Care Permits. (c) To the extent it participates in a particular Program, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary meets all of the requirements of participation and payment of Medicare, Medicaid, Tricare any other state or federal government health care programs, and any other public or private third party payor programs (collectively, “Programs”) and is a party to valid participation agreements for payment by such Programs, except as could not reasonably be expected to have a Material Adverse Effect. Except as set forth on Schedule 5.26(c), there is no investigation, audit, claim review, or other action pending or, to the knowledge of the Borrower, threatened which could result in a revocation, suspension, termination, probation, material restriction, material limitation, or non-renewal of any Program participation agreement or result in the Borrowers or any of its Subsidiaries exclusion from any Program, except as could not reasonably be expected to have a Material Adverse Effect. Schedule 5.26(c) sets forth an accurate, complete and current list of (i) all Medicaid, Tricare and other state and federal government health care program participation agreements, or, in the case of Medicare, each provider number, and (ii) the top twenty-five (25) payors, by revenue, in each case, of the Borrower and its Subsidiaries, on a consolidated basis, as of the Closing Date. (d) None of the Borrower, any of its Subsidiaries, or their respective officers, directors and, to the Borrowers knowledge, employees, agents and contractors has been or is currently excluded from participation in government health care programs pursuant to 42 U.S.C. § 1320a-7; except (i) as set forth on Schedule 5.26(d) and (ii) with respect to employees, agents or contractors, where exclusion from participation in such government health programs could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. (e) Except as set forth on Schedule 5.26(e), as of the Closing Date, none of the Borrower or any of its Subsidiaries, or any hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary (i) is a party to a corporate integrity agreement, (ii) has any reporting obligations pursuant to a settlement agreement, plan of correction, or other remedial measure entered into with any Governmental Authority, or (iii) has been served with or received any search warrant, subpoena, civil investigative demand or contact letter, or received notice of any audit (other than routine audits in the ordinary course of business) from any Governmental Agency related to its business operations. The Borrower and each of its Subsidiaries, as applicable, has complied in all material respects with the terms and conditions of any corporate integrity agreements, settlement agreements, plans of correction, other remedial measures, search warrants, subpoenas, civil investigative demands, or contract letters set forth on Schedule 5.26(e).
Appears in 2 contracts
Samples: Credit Agreement (Gentiva Health Services Inc), Credit Agreement (Gentiva Health Services Inc)
Compliance with Health Care Laws. Without limiting the generality of any other representation and warranty contained herein:
(a) Except The Borrowers and their Subsidiaries, when taken as could nota whole, individually are in compliance in all material respects with all material Health Care Laws 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 where the aggregatefailure 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 Effect, each of Borrower, its Subsidiaries, and their respective officers, directors, employees, agents and contractors (exercising their respective duties on behalf of the Borrower or any of its Subsidiaries) and each hospice that is not a Subsidiary operated by Borrower or a Subsidiary is, and within the last six years has been, in compliance with all relevant Health Care Laws, and, with respect to the civil monetary penalty law (42 U.S.C. § 1320a-7a), none of them has engaged in any conduct that would result in a material violation of any law or regulation for which penalties could be imposed under 42 U.S.C. § 1320a-7a.
(b) Except as set forth on Schedule 5.26(b) and except as could not, individually or in the aggregate reasonably be expected to have a Material Adverse Effect, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary has (i) all licenses, consents, certificates, permits, authorizations, approvals, franchises, registrations, certificates of need, accreditations, and other rights from, and has made all declarations and filings with4.22, all applicable Governmental Authorities reports, documents, claims, notices or approvals required to be filed, obtained, maintained or furnished by the Borrowers and accrediting organizations (each, a “their Subsidiaries pursuant to any Health Care Permit”) necessary Law to operate its business, and (ii) not received notice and has no knowledge that any Governmental Authority have been so filed, obtained, maintained or accreditation organization is considering limiting, suspending, terminating, or revoking any such Health Care Permit. All such Health Care Permits are valid and in full force and effect, furnished except as could where the failure to do so would not reasonably be expected to have a Material Adverse Effect, and the Borrower and each of its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary is in material compliance with the terms and conditions of all such Health Care Permits reports, documents, claims and with notices were complete and correct in all material respects on the rules and regulations of the Governmental Authorities and accrediting organizations having jurisdiction with respect to such Health Care Permitsdate filed (or were or will be corrected in or supplemented by a subsequent filing).
(c) To Each of the Borrowers and their Subsidiaries, to the extent that it participates in a particular Programis billing the related payor, each of has the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower requisite provider number or a Subsidiary meets all of the requirements of participation and payment of other Governmental Authorization to xxxx under Medicare, Medicaid, Tricare any other the respective Medicaid program in the state or federal government health care programsstates in which such entity operates, and any other public or private third party payor programs (collectively, “Private Third Party Payor Programs”) and is a party to valid participation agreements for payment by such Programs, except as could not reasonably be expected to have a Material Adverse Effect. Except as set forth on Schedule 5.26(c), there There is no investigation, audit, claim review, or other action pending orpending, or threatened to the knowledge of the BorrowerBorrowers, threatened which could would result in a revocation, suspension, termination, probation, material restriction, material limitation, or non-renewal of any Program participation agreement Governmental Third Party Payor or Private Third Party Payor (as defined below) provider number or result in any of the Borrowers Borrowers’ or any of its Subsidiaries their Subsidiaries’ exclusion from any ProgramGovernmental Third Party Payor Program or Private Third Party Payor Program which individually or in the aggregate, except as could not would reasonably be expected to have a Material Adverse Effect. Schedule 5.26(c) sets forth an accurateFor purposes of this Agreement, complete and current list of (i) all a “Governmental Third Party Payor” means Medicare, Medicaid, Tricare TRICARE, state government insurers and any other state and federal government health care program participation agreements, or, in the case of Medicare, each provider number, and (ii) the top twenty-five (25) payors, by revenue, in each case, of the Borrower and its Subsidiaries, on a consolidated basis, as of the Closing Date.
(d) None of the Borrower, any of its Subsidiaries, person or their respective officers, directors and, to the Borrowers knowledge, employees, agents and contractors has been or is currently excluded from participation in government health care programs pursuant to 42 U.S.C. § 1320a-7; except (i) as set forth on Schedule 5.26(d) and (ii) with respect to employees, agents or contractors, where exclusion from participation in such government health programs could not, individually entity which presently or in the aggregatefuture maintains Governmental Third Party Payor Programs. In addition, reasonably be expected to have a Material Adverse Effect.
(e) Except as set forth on Schedule 5.26(e)for purposes of this Agreement, as of “Governmental Third Party Payor Programs” means all governmental third party payor programs in which the Closing Date, none of the Borrower Borrowers or any of its Subsidiariestheir 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 any hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary (i) is a party to a corporate integrity agreement, (ii) has any reporting obligations pursuant to a settlement agreement, plan of correction, or other remedial measure entered into with any Governmental Authority, or (iii) has been served with or received any search warrant, subpoena, civil investigative demand or contact letter, or received notice of any audit (other than routine audits in the ordinary course of business) from any Governmental Agency related to its business operations. The Borrower and each of its Subsidiaries, as applicable, has complied in all material respects with the terms and conditions of any corporate integrity agreements, settlement agreements, plans of correction, other remedial measures, search warrants, subpoenas, civil investigative demands, or contract letters set forth on Schedule 5.26(eprivate insurance programs).
Appears in 1 contract
Samples: Credit Agreement (Amedisys Inc)
Compliance with Health Care Laws. Without limiting the generality of any other representation and warranty contained herein:
(a) Except as could notWithout limiting or qualifying Section 6.4 or any other provision of this Agreement, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, each of Borrower, its SubsidiariesBorrower will comply, and their respective officers, directors, employees, agents and contractors (exercising their respective duties on behalf of the Borrower or any of its Subsidiaries) will cause each other Loan Party and each hospice that is not a Subsidiary operated by of Borrower or a Subsidiary is, and within the last six years has beento comply, in compliance all material respects with all relevant applicable Health Care Laws, and, with respect Laws relating to the civil monetary penalty law (42 U.S.C. § 1320a-7a), none operation of them has engaged in any conduct that would result in a material violation of any law or regulation for which penalties could be imposed under 42 U.S.C. § 1320a-7a.
(b) Except as set forth on Schedule 5.26(b) and except as could not, individually or in the aggregate reasonably be expected to have a Material Adverse Effect, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary has (i) all licenses, consents, certificates, permits, authorizations, approvals, franchises, registrations, certificates of need, accreditations, and other rights from, and has made all declarations and filings with, all applicable Governmental Authorities and accrediting organizations (each, a “Health Care Permit”) necessary to operate its such Person’s business, and (ii) except where failure to comply would not received notice and has no knowledge that any Governmental Authority or accreditation organization is considering limiting, suspending, terminating, or revoking any such Health Care Permit. All such Health Care Permits are valid and in full force and effect, except as could not reasonably be expected to have a Material Adverse Effect, and the Borrower and each of its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary is in material compliance with the terms and conditions of all such Health Care Permits and with the rules and regulations of the Governmental Authorities and accrediting organizations having jurisdiction with respect to such Health Care Permits.
(c) To the extent it participates in a particular Program, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary meets all of the requirements of participation and payment of Medicare, Medicaid, Tricare any other state or federal government health care programs, and any other public or private third party payor programs (collectively, “Programs”) and is a party to valid participation agreements for payment by such Programs, except as could not reasonably be expected to have a Material Adverse Effect. Except as set forth on Schedule 5.26(c), there is no investigation, audit, claim review, or other action pending or, to the knowledge of the Borrower, threatened which could result in a revocation, suspension, termination, probation, material restriction, material limitation, or non-renewal of any Program participation agreement or result in the Borrowers or any of its Subsidiaries exclusion from any Program, except as could not reasonably be expected to have a Material Adverse Effect. Schedule 5.26(c) sets forth an accurate, complete and current list of (i) all Medicaid, Tricare and other state and federal government health care program participation agreements, or, in the case of Medicare, each provider number, and (ii) the top twenty-five (25) payors, by revenue, in each case, of the Borrower and its Subsidiaries, on a consolidated basis, as of the Closing Date.
(d) None of the Borrower, any of its Subsidiaries, or their respective officers, directors and, to the Borrowers knowledge, employees, agents and contractors has been or is currently excluded from participation in government health care programs pursuant to 42 U.S.C. § 1320a-7; except (i) as set forth on Schedule 5.26(d) and (ii) with respect to employees, agents or contractors, where exclusion from participation in such government health programs could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(eb) Except Borrower will, 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 all applicable Services, except to the extent such failure to keep in full force and effect or maintain would not reasonably be expected to have a Material Adverse Effect.
(ii) Promptly furnish or cause to be furnished to the Agent, with respect to matters that could reasonably be expected to have a Material Adverse Effect, (w) copies of all material written 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, (x) copies of all material written 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, (y) copies of all material written warnings and material untitled letters as set forth on Schedule 5.26(e)well as other material documents received by Loan Parties or any of their Subsidiaries from the FDA, as CMS or any other Governmental Authority relating to or arising out of the Closing Date, none conduct of the Borrower Loan Parties or any of their Subsidiaries 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 (z) written notice of any material investigation or material audit or similar proceeding by the FDA, 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 written 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 written allegations by any Governmental Authority (or any hospice that is not a Subsidiary but is operated by Borrower agent thereof) of fraudulent activities of any Loan Party or a Subsidiary (i) is a party any of its Subsidiaries in relation to a corporate integrity agreementthe provision of clinical research or related services. Notwithstanding anything to the contrary in any Loan Document, (ii) has no Loan Party or any reporting obligations pursuant of its Subsidiaries shall be required to a settlement agreement, plan of correction, furnish to Agent or any Lender patient- related or other remedial measure entered into with information, the disclosure of which to Agent or such Lender is prohibited by any Governmental Authority, or (iii) has been served with or received any search warrant, subpoena, civil investigative demand or contact letter, or received notice of any audit (other than routine audits in the ordinary course of business) from any Governmental Agency related to its business operations. The Borrower and each of its Subsidiaries, as applicable, has complied in all material respects with the terms and conditions of any corporate integrity agreements, settlement agreements, plans of correction, other remedial measures, search warrants, subpoenas, civil investigative demands, or contract letters set forth on Schedule 5.26(e)applicable law.
Appears in 1 contract
Samples: Credit Agreement (Biolase, Inc)
Compliance with Health Care Laws. Without limiting the generality of any other provision that is set forth herein (including, without limitation, any covenant, representation or warranty), the Borrower and warranty contained herein:
each of its Subsidiaries, and each of the Borrower’s and each Subsidiary’s employees and contractors in the exercise of their respective duties on behalf of the Borrower, any such Subsidiary or any facilities where such licensed employees and contractors perform services on behalf of customers of the Borrower or any Subsidiary, is in compliance in all respects with all applicable statutes, laws, ordinances, rules and regulations of any federal, state or local governmental authority with respect to regulatory matters primarily relating to patient healthcare (a) Except collectively, “Healthcare Laws”), except where non-compliance, either individually or in the aggregate, could not reasonably be expected to result in a Material Adverse Effect. The Borrower and each of its Subsidiaries has maintained in all material respects all records required to be maintained by the Healthcare Laws and, to the knowledge of the Loan Parties, there are no presently existing circumstances which would result or likely would result in violations of the Healthcare Laws, except where such violations, either individually or in the aggregate, could not reasonably be expected to result in a Material Adverse Effect. The Borrower and its Subsidiaries and, to the Loan Parties’ knowledge, the owners of other businesses managed by the Borrower or its Subsidiaries have such permits, licenses, franchises, certificates and other approvals or authorizations of Governmental Authorities as could notare necessary under applicable Healthcare Laws to own their respective properties and to conduct their respective business (including without limitation such permits as are required under such federal, state and other health care laws, and under licensure laws and such insurance laws and regulations, as are applicable thereto), except where the failure to have such permits, licenses, franchises, certificates and other approvals or authorizations of Governmental Authorities, individually or in the aggregate, could not reasonably be expected to have result in a Material Adverse Effect. In addition, each such employee and contractor holds, without restriction, such permits, licenses, franchises, certificates and other approvals or authorizations of Borrower, its Subsidiaries, Governmental Authorities as are necessary under applicable Healthcare Laws to perform services on behalf of any customer of the Borrower or any Subsidiary in the exercise of such employees’ and their respective officers, directors, employees, agents and contractors (exercising their contractors’ respective duties on behalf of the Borrower or any of its Subsidiaries) and each hospice that is not a Subsidiary operated by Borrower or a Subsidiary issuch Subsidiary, and within except where the last six years has been, in compliance with all relevant Health Care Laws, and, with respect to the civil monetary penalty law (42 U.S.C. § 1320a-7a), none of them has engaged in any conduct that would result in a material violation of any law or regulation for which penalties could be imposed under 42 U.S.C. § 1320a-7a.
(b) Except as set forth on Schedule 5.26(b) and except as could not, individually or in the aggregate reasonably be expected failure to have a Material Adverse Effect, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary has (i) all licenses, consents, certificates, such permits, authorizations, approvalslicenses, franchises, registrations, certificates of need, accreditations, and other rights from, and has made all declarations and filings with, all applicable approvals or authorizations of Governmental Authorities and accrediting organizations (each, a “Health Care Permit”) necessary to operate its business, and (ii) not received notice and has no knowledge that any Governmental Authority or accreditation organization is considering limiting, suspending, terminating, or revoking any such Health Care Permit. All such Health Care Permits are valid and in full force and effect, except as could not reasonably be expected to have a Material Adverse Effect, and the Borrower and each of its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary is in material compliance with the terms and conditions of all such Health Care Permits and with the rules and regulations of the Governmental Authorities and accrediting organizations having jurisdiction with respect to such Health Care Permits.
(c) To the extent it participates in a particular Program, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary meets all of the requirements of participation and payment of Medicare, Medicaid, Tricare any other state or federal government health care programs, and any other public or private third party payor programs (collectively, “Programs”) and is a party to valid participation agreements for payment by such Programs, except as could not reasonably be expected to have a Material Adverse Effect. Except as set forth on Schedule 5.26(c), there is no investigation, audit, claim review, or other action pending or, to the knowledge of the Borrower, threatened which could result in a revocation, suspension, termination, probation, material restriction, material limitation, or non-renewal of any Program participation agreement or result in the Borrowers or any of its Subsidiaries exclusion from any Program, except as could not reasonably be expected to have a Material Adverse Effect. Schedule 5.26(c) sets forth an accurate, complete and current list of (i) all Medicaid, Tricare and other state and federal government health care program participation agreements, or, in the case of Medicare, each provider number, and (ii) the top twenty-five (25) payors, by revenue, in each case, of the Borrower and its Subsidiaries, on a consolidated basis, as of the Closing Date.
(d) None of the Borrower, any of its Subsidiaries, or their respective officers, directors and, to the Borrowers knowledge, employees, agents and contractors has been or is currently excluded from participation in government health care programs pursuant to 42 U.S.C. § 1320a-7; except (i) as set forth on Schedule 5.26(d) and (ii) with respect to employees, agents or contractors, where exclusion from participation in such government health programs could notAuthorities, individually or in the aggregate, could not reasonably be expected to have result in a Material Adverse Effect.
(e) Except as set forth . Further, each such employee and contractor, if required by the applicable facility where such employee or contractor performs services on Schedule 5.26(e), as of the Closing Date, none behalf of the Borrower or any Subsidiary, holds unrestricted medical staff privileges to perform professional services at such facility, except where such failure to maintain medical staff privileges could not reasonably be expected to result in a Material Adverse Effect. Neither the Borrower nor any of its SubsidiariesSubsidiaries are enrolled in, bxxx to or receive any reimbursement from third party payors, including without limitation, Medicare, Medicaid, or any hospice that is not a Subsidiary but is operated by Borrower other federal, state, or a Subsidiary other government or commercial health care program. Neither the Borrower, any Subsidiary, or any of their respective employees or independent contractors: (i) is have been convicted of a party criminal offense related to a corporate integrity agreement, healthcare (unless such individual has been officially reinstated into the federal healthcare programs by the U.S. Department of Health and Human Services Office of Inspector General (“OIG”)); (ii) has are currently under sanction, exclusion or investigation (civil or criminal) by any reporting obligations pursuant to a settlement agreementfederal or state enforcement, plan of correctionregulatory, administrative or other remedial measure entered into with any Governmental Authority, licensing agency or is ineligible for federal or state program participation; or (iii) has been served with are currently listed on the General Services Administration List of Parties Excluded from the Federal Procurement and Non-Procurement Programs or received any search warrant, subpoena, civil investigative demand or contact letter, or received notice the OIG List of any audit (other than routine audits in the ordinary course of business) from any Governmental Agency related to its business operations. The Borrower and each of its Subsidiaries, as applicable, has complied in all material respects with the terms and conditions of any corporate integrity agreements, settlement agreements, plans of correction, other remedial measures, search warrants, subpoenas, civil investigative demands, or contract letters set forth on Schedule 5.26(e)Excluded Individuals/Entities.
Appears in 1 contract
Compliance with Health Care Laws. Without limiting the generality of Section 8.15 or any other representation and or warranty contained made herein:
(a) Except as could not, individually or in the aggregate, reasonably be expected to have a Material Adverse EffectBorrowers' knowledge, each of Borrower, its Subsidiariesthe Facilities, and their respective officers, directors, employees, agents each of its licensed employees and contractors (exercising other than contracted agencies) in the exercise of their respective duties on behalf of each of the Borrower or any of its Subsidiaries) and each hospice that Facilities, is not a Subsidiary operated by Borrower or a Subsidiary is, and within the last six years has been, in compliance with all relevant applicable statutes, laws, ordinances, rules, and regulations of any Governmental Authority (including without limitation Section 1128B(b) of the Social Security Act, as amended, 42 U.S.C. Section 1320a-7(b) (Criminal Penalties Involving Medicare or State Health Care Programs), commonly referred to as the "Federal Anti-Kickback Statute," and the Section 1877 of the Social Security Act (Prohibition Against Certain Referrals), commonly referred to as "Xxxxx Statute" (collectively, "Healthcare Laws")). Borrowers have maintained in all material respects all records required to be maintained by the Joint Commission on Accreditation of Healthcare Organizations, the Food and Drug Administration, the Drug Enforcement Agency, the State Boards of Pharmacy, and, with respect to the civil monetary penalty law (42 U.S.C. § 1320a-7a)extent required by the Healthcare Laws, none of them has engaged in any conduct that would result in a material violation of any law or regulation for which penalties could be imposed under 42 U.S.C. § 1320a-7a.
(b) Except as set forth on Schedule 5.26(b) the federal and except as could not, individually or in the aggregate reasonably be expected to have a Material Adverse Effect, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary has (i) all licenses, consents, certificates, permits, authorizations, approvals, franchises, registrations, certificates of need, accreditations, and other rights from, and has made all declarations and filings with, all applicable Governmental Authorities and accrediting organizations (each, a “Health Care Permit”) necessary to operate its business, and (ii) not received notice and has no knowledge that any Governmental Authority or accreditation organization is considering limiting, suspending, terminating, or revoking any such Health Care Permit. All such Health Care Permits are valid and in full force and effect, except as could not reasonably be expected to have a Material Adverse Effect, and the Borrower and each of its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary is in material compliance with the terms and conditions of all such Health Care Permits and with the rules and regulations of the Governmental Authorities and accrediting organizations having jurisdiction with respect to such Health Care Permits.
(c) To the extent it participates in a particular Program, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary meets all of the requirements of participation and payment of state Medicare, Medicaid, Tricare any other state or federal government health care and TRICARE programs, and any other public or private third party payor programs (collectively, “Programs”) and is a party to valid participation agreements for payment by such Programs, except as could not reasonably be expected to have a Material Adverse Effect. Except as set forth on Schedule 5.26(c), there is no investigation, audit, claim review, or other action pending orand, to the knowledge of the BorrowerBorrowers, threatened there are no presently existing circumstances which could would result or likely would result in a revocationmaterial violations of the Healthcare Laws. Each Borrower and its Affiliates and the owners of the Facilities and other businesses managed by any Borrower or its Affiliates have such Authorizations of all Governmental Authorities as are necessary under applicable Law to own their respective properties and to conduct their respective business (including without limitation such Authorizations as are required under federal, suspensionstate and other health care Laws, terminationand under such HMO or similar licensure Laws and such insurance Laws and regulations applicable thereto), probationand with respect to those Facilities and other businesses that participate in Medicare, material restrictionMedicaid, material limitationand/or TRICARE to receive reimbursement under Medicare, Medicaid, and TRICARE. To Borrowers' knowledge, there currently exist no restrictions, deficiencies, required plans of corrective actions, or non-renewal of any Program participation agreement other such remedial measures with respect to federal and state Medicare, Medicaid, and TRICARE certifications or result in the Borrowers or any of its Subsidiaries exclusion from any Program, except as licensure that could not reasonably be expected to have result in a Material Adverse Effect. Schedule 5.26(c) sets forth an accurate, complete and current list of (i) all Medicaid, Tricare and other state and federal government health care program participation agreements, or, in the case of Medicare, each provider number, and (ii) the top twenty-five (25) payors, by revenue, in each case, of the Borrower and its Subsidiaries, on a consolidated basis, as of the Closing DateEvent.
(d) None of the Borrower, any of its Subsidiaries, or their respective officers, directors and, to the Borrowers knowledge, employees, agents and contractors has been or is currently excluded from participation in government health care programs pursuant to 42 U.S.C. § 1320a-7; except (i) as set forth on Schedule 5.26(d) and (ii) with respect to employees, agents or contractors, where exclusion from participation in such government health programs could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(e) Except as set forth on Schedule 5.26(e), as of the Closing Date, none of the Borrower or any of its Subsidiaries, or any hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary (i) is a party to a corporate integrity agreement, (ii) has any reporting obligations pursuant to a settlement agreement, plan of correction, or other remedial measure entered into with any Governmental Authority, or (iii) has been served with or received any search warrant, subpoena, civil investigative demand or contact letter, or received notice of any audit (other than routine audits in the ordinary course of business) from any Governmental Agency related to its business operations. The Borrower and each of its Subsidiaries, as applicable, has complied in all material respects with the terms and conditions of any corporate integrity agreements, settlement agreements, plans of correction, other remedial measures, search warrants, subpoenas, civil investigative demands, or contract letters set forth on Schedule 5.26(e).
Appears in 1 contract
Samples: Term Loan and Note Purchase Agreement (Sun Healthcare Group Inc)
Compliance with Health Care Laws. Without limiting the generality of any other representation and warranty contained herein:
(a) Except The Company and its Subsidiaries, when taken as could nota whole, individually are in compliance in all material respects with all material Health Care Laws applicable to it, its products and its properties or other assets or its business or operation. Each of the Company and its 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 the aggregateCompany nor any of its 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 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 Effect, each of Borrower, its Subsidiaries, and their respective officers, directors, employees, agents and contractors (exercising their respective duties on behalf of the Borrower or any of its Subsidiaries) and each hospice that is not a Subsidiary operated by Borrower or a Subsidiary is, and within the last six years has been, in compliance with all relevant Health Care Laws, and, with respect to the civil monetary penalty law (42 U.S.C. § 1320a-7a), none of them has engaged in any conduct that would result in a material violation of any law or regulation for which penalties could be imposed under 42 U.S.C. § 1320a-7a.
(b) Except as set forth on Schedule 5.26(b) and except as could not5.22, individually all reports, documents, claims, notices or in approvals required to be filed, obtained, maintained or furnished by the aggregate reasonably be expected to have a Material Adverse Effect, each of the Borrower Company and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary has (i) all licenses, consents, certificates, permits, authorizations, approvals, franchises, registrations, certificates of need, accreditations, and other rights from, and has made all declarations and filings with, all applicable Governmental Authorities and accrediting organizations (each, a “pursuant to any Health Care Permit”) necessary Law to operate its business, and (ii) not received notice and has no knowledge that any Governmental Authority have been so filed, obtained, maintained or accreditation organization is considering limiting, suspending, terminating, or revoking any such Health Care Permit. All such Health Care Permits are valid and in full force and effect, furnished except as could where the failure to do so would not reasonably be expected to have a Material Adverse Effect, and the Borrower and each of its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary is in material compliance with the terms and conditions of all such Health Care Permits reports, documents, claims and with notices were complete and correct in all material respects on the rules and regulations of the Governmental Authorities and accrediting organizations having jurisdiction with respect to such Health Care Permitsdate filed (or were or will be corrected in or supplemented by a subsequent filing).
(c) To Each of the Company and its Subsidiaries, to the extent that it participates in a particular Programis billing the applicable payor, each of has the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower requisite provider number or a Subsidiary meets all of the requirements of participation and payment of other Governmental Authorization to xxxx under Medicare, Medicaidthe respective Medicaid program in the state or states in which such entity operates, Tricare any other state or federal government health care programs, Governmental Third Party Payor Program and any other public or private third party payor programs (collectively, “Private Third Party Payor Programs”) and is a party to valid participation agreements for payment by such Programs, except as could not reasonably be expected to have a Material Adverse Effect. Except as set forth on Schedule 5.26(c), there There is no investigation, audit, claim review, or other action pending orpending, or threatened to the knowledge of the BorrowerLoan Parties, threatened which could would result in a revocation, suspension, termination, probation, material restriction, material limitation, or non-renewal of any Program participation agreement Governmental Third Party Payor or Private Third Party Payor provider number or result in any of the Borrowers Company’s or any of its Subsidiaries exclusion from any Program, except as could not reasonably be expected to have a Material Adverse Effect. Schedule 5.26(c) sets forth an accurate, complete and current list of (i) all Medicaid, Tricare and other state and federal government health care program participation agreements, or, in the case of Medicare, each provider number, and (ii) the top twenty-five (25) payors, by revenue, in each case, of the Borrower and its Subsidiaries, on a consolidated basis, as of the Closing Date.
(d) None of the Borrower, any of its Subsidiaries, or their respective officers, directors and, to the Borrowers knowledge, employees, agents and contractors has been or is currently excluded from participation in government health care programs pursuant to 42 U.S.C. § 1320a-7; except (i) as set forth on Schedule 5.26(d) and (ii) with respect to employees, agents or contractors, where exclusion from participation in such government health programs could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(e) Except as set forth on Schedule 5.26(e), as of the Closing Date, none of the Borrower or any of its Subsidiaries, or any hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary (i) is a party to a corporate integrity agreement, (ii) has any reporting obligations pursuant to a settlement agreement, plan of correction, or other remedial measure entered into with any Governmental Authority, or (iii) has been served with or received any search warrant, subpoena, civil investigative demand or contact letter, or received notice of any audit (other than routine audits in the ordinary course of business) from any Governmental Agency related to its business operations. The Borrower and each of its Subsidiaries, as applicable, has complied in all material respects with the terms and conditions of any corporate integrity agreements, settlement agreements, plans of correction, other remedial measures, search warrants, subpoenas, civil investigative demands, or contract letters set forth on Schedule 5.26(e).its
Appears in 1 contract
Samples: Credit Agreement (Amedisys Inc)
Compliance with Health Care Laws. Without limiting the generality of any other representation and warranty contained herein:
(a) Except as could notWithout limiting or qualifying Section 6.4 or any other provision of this Agreement, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, each of Borrower, its SubsidiariesBorrower will comply, and their respective officers, directors, employees, agents and contractors (exercising their respective duties on behalf of the Borrower or any of its Subsidiaries) will cause each other Loan Party and each hospice that is not a Subsidiary operated by of Borrower or a Subsidiary is, and within the last six years has beento comply, in compliance all material respects with all relevant applicable Health Care Laws, and, with respect Laws relating to the civil monetary penalty law (42 U.S.C. § 1320a-7a), none operation of them has engaged in any conduct that would result in a material violation of any law or regulation for which penalties could be imposed under 42 U.S.C. § 1320a-7a.
(b) Except as set forth on Schedule 5.26(b) and except as could not, individually or in the aggregate reasonably be expected to have a Material Adverse Effect, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary has (i) all licenses, consents, certificates, permits, authorizations, approvals, franchises, registrations, certificates of need, accreditations, and other rights from, and has made all declarations and filings with, all applicable Governmental Authorities and accrediting organizations (each, a “Health Care Permit”) necessary to operate its such Person’s business, and (ii) except where failure to comply would not received notice and has no knowledge that any Governmental Authority or accreditation organization is considering limiting, suspending, terminating, or revoking any such Health Care Permit. All such Health Care Permits are valid and in full force and effect, except as could not reasonably be expected to have a Material Adverse Effect, and the Borrower and each of its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary is in material compliance with the terms and conditions of all such Health Care Permits and with the rules and regulations of the Governmental Authorities and accrediting organizations having jurisdiction with respect to such Health Care Permits.
(c) To the extent it participates in a particular Program, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary meets all of the requirements of participation and payment of Medicare, Medicaid, Tricare any other state or federal government health care programs, and any other public or private third party payor programs (collectively, “Programs”) and is a party to valid participation agreements for payment by such Programs, except as could not reasonably be expected to have a Material Adverse Effect. Except as set forth on Schedule 5.26(c), there is no investigation, audit, claim review, or other action pending or, to the knowledge of the Borrower, threatened which could result in a revocation, suspension, termination, probation, material restriction, material limitation, or non-renewal of any Program participation agreement or result in the Borrowers or any of its Subsidiaries exclusion from any Program, except as could not reasonably be expected to have a Material Adverse Effect. Schedule 5.26(c) sets forth an accurate, complete and current list of (i) all Medicaid, Tricare and other state and federal government health care program participation agreements, or, in the case of Medicare, each provider number, and (ii) the top twenty-five (25) payors, by revenue, in each case, of the Borrower and its Subsidiaries, on a consolidated basis, as of the Closing Date.
(d) None of the Borrower, any of its Subsidiaries, or their respective officers, directors and, to the Borrowers knowledge, employees, agents and contractors has been or is currently excluded from participation in government health care programs pursuant to 42 U.S.C. § 1320a-7; except (i) as set forth on Schedule 5.26(d) and (ii) with respect to employees, agents or contractors, where exclusion from participation in such government health programs could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(eb) Except Borrower will, 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 all applicable Services, except to the extent such failure to keep in full force and effect or maintain would not reasonably be expected to have a Material Adverse Effect.
(ii) Promptly furnish or cause to be furnished to the Agent, with respect to matters that could reasonably be expected to have a Material Adverse Effect, (w) copies of all material written 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, (x) copies of all material written 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, (y) copies of all material written warnings and material untitled letters as set forth on Schedule 5.26(e)well as other material documents received by Loan Parties or any of their Subsidiaries from the FDA, as CMS or any other Governmental Authority relating to or arising out of the Closing Date, none conduct of the Borrower Loan Parties or any of their Subsidiaries 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 [Biolase] Credit Agreement #61304369 or regulation of similar import and (z) written notice of any material investigation or material audit or similar proceeding by the FDA, 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 written 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 written allegations by any Governmental Authority (or any hospice that is not a Subsidiary but is operated by Borrower agent thereof) of fraudulent activities of any Loan Party or a Subsidiary (i) is a party any of its Subsidiaries in relation to a corporate integrity agreementthe provision of clinical research or related services. Notwithstanding anything to the contrary in any Loan Document, (ii) has no Loan Party or any reporting obligations pursuant of its Subsidiaries shall be required to a settlement agreement, plan of correction, furnish to Agent or any Lender patient-related or other remedial measure entered into with information, the disclosure of which to Agent or such Lender is prohibited by any Governmental Authority, or (iii) has been served with or received any search warrant, subpoena, civil investigative demand or contact letter, or received notice of any audit (other than routine audits in the ordinary course of business) from any Governmental Agency related to its business operations. The Borrower and each of its Subsidiaries, as applicable, has complied in all material respects with the terms and conditions of any corporate integrity agreements, settlement agreements, plans of correction, other remedial measures, search warrants, subpoenas, civil investigative demands, or contract letters set forth on Schedule 5.26(e)applicable law.
Appears in 1 contract
Samples: Credit Agreement (Biolase, Inc)
Compliance with Health Care Laws. Without limiting the generality of any other representation and warranty contained herein:
(a) Except as could notWithout limiting or qualifying any other provision of this Agreement, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, each of Borrower, its SubsidiariesAdministrative Borrower will comply, and their respective officers, directors, employees, agents and contractors (exercising their respective duties on behalf of the Borrower or any of its Subsidiaries) will cause each other Credit Party and each hospice that is not a Subsidiary operated by Borrower or a Subsidiary is, and within the last six years has been, in compliance with all relevant Health Care LawsSubsidiary, and, with respect to the civil monetary penalty law (42 U.S.C. § 1320a-7a), none of them has engaged in any conduct that would result in a material violation of any law or regulation for which penalties could be imposed under 42 U.S.C. § 1320a-7a.
(b) Except as set forth on Schedule 5.26(b) and except as could not, individually or in the aggregate reasonably be expected to have a Material Adverse EffectProducts, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary has (i) all licensesCompany Partner, consents, certificates, permits, authorizations, approvals, franchises, registrations, certificates of need, accreditations, and other rights from, and has made all declarations and filings with, to comply with all applicable Governmental Authorities and accrediting organizations (each, a “Health Care Permit”) necessary Laws relating to operate its the operation of such Person’s business, and (ii) not received notice and has no knowledge that any Governmental Authority or accreditation organization is considering limiting, suspending, terminating, or revoking any such Health Care Permit. All such Health Care Permits are valid and in full force and effect, except as where failure to do so could not reasonably be expected to have a Material Adverse Effect, and the Borrower and each of its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary is in material compliance with the terms and conditions of all such Health Care Permits and with the rules and regulations of the Governmental Authorities and accrediting organizations having jurisdiction with respect to such Health Care Permits.
(c) To the extent it participates in a particular Program, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary meets all of the requirements of participation and payment of Medicare, Medicaid, Tricare any other state or federal government health care programs, and any other public or private third party payor programs (collectively, “Programs”) and is a party to valid participation agreements for payment by such Programs, except as could not reasonably be expected to have a Material Adverse Effect. Except as set forth on Schedule 5.26(c), there is no investigation, audit, claim review, or other action pending or, to the knowledge of the Borrower, threatened which could result in a revocation, suspension, termination, probation, material restriction, material limitation, or non-renewal of any Program participation agreement or result in the Borrowers or any of its Subsidiaries exclusion from any Program, except as could not reasonably be expected to have a Material Adverse Effect. Schedule 5.26(c) sets forth an accurate, complete and current list of (i) all Medicaid, Tricare and other state and federal government health care program participation agreements, or, in the case of Medicare, each provider number, and (ii) the top twenty-five (25) payors, by revenue, in each case, of the Borrower and its Subsidiaries, on a consolidated basis, as of the Closing Date.
(d) None of the Borrower, any of its Subsidiaries, or their respective officers, directors and, to the Borrowers knowledge, employees, agents and contractors has been or is currently excluded from participation in government health care programs pursuant to 42 U.S.C. § 1320a-7; except (i) as set forth on Schedule 5.26(d) and (ii) with respect to employees, agents or contractors, where exclusion from participation in such government health programs could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(eb) Except as set forth Administrative Borrower will maintain, and will cause each other Credit Party and each Subsidiary, to maintain, and, with respect to the Products, will require each Company Partner, to maintain, all records required to be maintained by the FDA and any other Governmental Authority or otherwise required under any Health Care Law except where failure could not reasonably be expected to have a Material Adverse Effect.
(c) Administrative Borrower will, and will cause each other Credit Party and each Subsidiary, and, with respect to the Products, each Company Partner, to keep in full force and effect all Permits required to operate the business of Administrative Borrower, each other Credit Party and each Subsidiary, and with respect to the Products, each Company Partner, under applicable Health Care Laws, except where failure to do so could not reasonably be expected to have a Material Adverse Effect.
(d) Administrative Borrower will maintain, and will cause each other Credit Party and Subsidiary, to maintain on Schedule 5.26(e)its behalf, as of the Closing Datea corporate compliance program that is reasonably designed to promote compliance with applicable Health Care Laws. Administrative Borrower will permit and will cause such other Credit Parties and Subsidiaries to permit, none of the Borrower or Administrative Agent and/or any of its Subsidiariesoutside consultants to review such corporate compliance program(s) from time to time, during Administrative Borrower’s business hours or at such other times as approved by Administrative Borrower, upon reasonable advance notice; provided, however, that such review will not be permitted to the extent any materials or documents are protected by the attorney-client privilege, work product doctrine or other similar privilege. Unless an Event of Default exists, such reviews shall be conducted no more than once per calendar year during the term of this Agreement. Additionally, notwithstanding anything to the contrary in this Agreement, no Credit Party or Subsidiary shall be required to furnish to Administrative Agent or Lender any “protected health information,” as defined under HIPAA, or any hospice that patient related information, to the extent such disclosure to Administrative Agent or Lender is not a Subsidiary but is operated prohibited by Borrower or a Subsidiary (i) is a party to a corporate integrity agreement, (ii) has any reporting obligations pursuant to a settlement agreement, plan of correction, or other remedial measure entered into with any Governmental Authority, or (iii) has been served with or received any search warrant, subpoena, civil investigative demand or contact letter, or received notice of any audit (other than routine audits in the ordinary course of business) from any Governmental Agency related to its business operations. The Borrower and each of its Subsidiaries, as applicable, has complied in all material respects with the terms and conditions of any corporate integrity agreements, settlement agreements, plans of correction, other remedial measures, search warrants, subpoenas, civil investigative demands, or contract letters set forth on Schedule 5.26(e)Health Care Laws.
Appears in 1 contract
Compliance with Health Care Laws. Without limiting the generality of any other representation and warranty contained hereinSection 6.16 above:
(a) Except as could notNeither Borrower nor any other Obligated Party is in violation of any applicable Health Care Laws, individually or in except to the aggregate, extent such violation would not reasonably be expected to have a Material Adverse Effect, each of Borrower, its Subsidiaries, and their respective officers, directors, employees, agents and contractors (exercising their respective duties on behalf of the Borrower or any of its Subsidiaries) and each hospice that is not a Subsidiary operated by Borrower or a Subsidiary is, and within the last six years has been, in compliance with all relevant Health Care Laws, and, with respect to the civil monetary penalty law (42 U.S.C. § 1320a-7a), none of them has engaged in any conduct that would result in a material violation of any law or regulation for which penalties could be imposed under 42 U.S.C. § 1320a-7a.
(b) Except as set forth on Schedule 5.26(b) and except as could not, individually or in the aggregate reasonably be expected to have a Material Adverse Effect, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary other Obligated Party has (i) all licenses, consents, certificates, permitsapplicable Health Care Permits, authorizations, approvals, franchises, registrations, certificates of need, accreditations, qualifications and other rights from, and has made all declarations and filings with, all applicable Governmental Authorities Authorities, all self-regulatory authorities and accrediting organizations all courts and other tribunals (each, a an “Health Care PermitAuthorization”) necessary to operate its business, engage in the business conducted by it and (ii) not received written or oral notice and has no knowledge that any Governmental Authority or accreditation organization is considering limiting, suspendingrestricting, terminating, suspending or revoking any such Health Care PermitAuthorization. All such Health Care Permits are valid and in full force and effect, except as could not reasonably be expected to have a Material Adverse Effect, and the Borrower and each of its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary other Obligated Party is in compliance in all material compliance respects with the terms and conditions of all such Health Care Permits Authorizations and with the rules and regulations of the Governmental Authorities and accrediting organizations regulatory authorities having jurisdiction with respect to such Health Care PermitsAuthorizations.
(c) To Borrower and each other Obligated Party has, as applicable, the requisite provider or supplier number, enrollment, participation and/or agreement or Authorization to xxxx a Medical Reimbursement Programs that such Person currently bills.
(d) Borrower and each other Obligated Party has not and will not xxxx a Governmental Payor Program or beneficiaries to the extent it participates in such Person is a particular Program, each of the Borrower and its Subsidiaries and each hospice that is not beneficiary under a Subsidiary but is operated by Borrower or a Subsidiary meets all of the requirements Governmental Payor Program (regardless of participation and payment of Medicare, Medicaid, Tricare status).
(e) Neither Borrower nor any other state or federal government health care programs, and any other public or private third party payor programs (collectively, “Programs”) and is a party to valid participation agreements for payment by such Programs, except as could not reasonably be expected to have a Material Adverse Effect. Except as set forth on Schedule 5.26(c)Obligated Party has received written notice of and, there is no actual or, to the knowledge of Borrower, threatened investigation, audit, claim review, or other action pending or, to the knowledge of the Borrower, threatened which could reasonably be expected to result in a revocation, suspension, termination, probation, material restriction, material limitation, or non-renewal of any Program participation agreement provider number or Authorization or result in the Borrowers Borrower’s or any of its Subsidiaries other Obligated Party’s exclusion from any a Medical Reimbursement Program or Governmental Payor Program, except as could not reasonably be expected to have a Material Adverse Effect. Schedule 5.26(c) sets forth an accurate, complete and current list of (i) all Medicaid, Tricare and other state and federal government health care program participation agreements, or, in the case of Medicare, each provider number, and (ii) the top twenty-five (25) payors, by revenue, in each case, of the Borrower and its Subsidiaries, on a consolidated basis, as of the Closing Date.
(df) None of the Borrower, Neither Borrower nor any of its Subsidiariesother Obligated Party is or has been, or their respective officers, directors and, to the Borrowers knowledge, employees, agents and contractors has been or is currently threatened to be, excluded from participation in government U.S. health care programs pursuant to 42 U.S.C. § 1320a-7; except (i) as set forth on Schedule 5.26(d) and (ii) with respect to employees, agents §1320(a)7 or contractors, where exclusion from participation in such government health programs could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effectany related regulations.
(eg) Except as set forth Borrower, each other Obligated Party, and each Health Care Provider or other licensed medical personnel of Borrower and each other Obligated Party who perform medical or similar professional services for or on Schedule 5.26(e), as behalf of the Closing Date, none of the Borrower or any other Obligated Party have, to the knowledge of its SubsidiariesBorrower, complied and currently are in compliance with all licenses, permits and other Authorizations required to provide such services under any applicable Health Care Laws. The Health Care Providers hold all licenses, permits and other Authorizations that are required for such Health Care Provider to provide the services provided by such Health Care Provider for Borrower and each other Obligated Party, and each such license, permit and other Authorization is in full force and effect and, to the knowledge of Borrower, no suspension, revocation or cancellation of any hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary (i) is a party to a corporate integrity agreementsuch license, (ii) has any reporting obligations pursuant to a settlement agreement, plan of correction, permit or other remedial measure entered into with Authorization is threatened, in each case.
(h) Neither Borrower nor any other Obligated Party nor any of the Health Care Providers has received any written notice from any Governmental Authority, nor is there any actual or, to the knowledge of Borrower, threatened investigation, inquiry, or administrative or judicial action, hearing, or enforcement proceeding by any Governmental Authority, against Borrower, any other Obligated Party, any party contracting with any Obligated Party, or any of the respective Health Care Providers, regarding any violation of applicable Health Care Law.
(iiii) No Person contracting with an Obligated Party is or has been, or has been served with threatened to be excluded from U.S. health care programs pursuant to 42 U.S.C. §1320(a)7 or received any search warrant, subpoena, civil investigative demand or contact letter, or received notice of any audit (other than routine audits in the ordinary course of business) from any Governmental Agency related to its business operations. The Borrower and each of its Subsidiaries, as applicable, has complied in all material respects with the terms and conditions of any corporate integrity agreements, settlement agreements, plans of correction, other remedial measures, search warrants, subpoenas, civil investigative demands, or contract letters set forth on Schedule 5.26(e)regulations.
Appears in 1 contract
Compliance with Health Care Laws. Without limiting the generality of any other representation and warranty contained herein:
(a) Except as could notWithout limiting or qualifying Section 6.4 or any other provision of this Agreement, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, each of Borrower, its SubsidiariesBorrower will comply, and their respective officers, directors, employees, agents and contractors (exercising their respective duties on behalf of the Borrower or any of its Subsidiaries) and will cause each hospice that is not a Subsidiary operated by Borrower or a Subsidiary is, and within the last six years has beenother Loan Party to comply, in compliance all material respects with all relevant applicable Health Care Laws, and, with respect Laws relating to the civil monetary penalty law (42 U.S.C. § 1320a-7a), none operation of them has engaged in any conduct that would result in a material violation of any law or regulation for which penalties could be imposed under 42 U.S.C. § 1320a-7a.
(b) Except as set forth on Schedule 5.26(b) and except as could not, individually or in the aggregate reasonably be expected to have a Material Adverse Effect, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary has (i) all licenses, consents, certificates, permits, authorizations, approvals, franchises, registrations, certificates of need, accreditations, and other rights from, and has made all declarations and filings with, all applicable Governmental Authorities and accrediting organizations (each, a “Health Care Permit”) necessary to operate its such Person’s business, and (ii) except where failure to comply would not received notice and has no knowledge that any Governmental Authority or accreditation organization is considering limiting, suspending, terminating, or revoking any such Health Care Permit. All such Health Care Permits are valid and in full force and effect, except as could not reasonably be expected to have a Material Adverse Effect, and the Borrower and each of its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary is in material compliance with the terms and conditions of all such Health Care Permits and with the rules and regulations of the Governmental Authorities and accrediting organizations having jurisdiction with respect to such Health Care Permits.
(c) To the extent it participates in a particular Program, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary meets all of the requirements of participation and payment of Medicare, Medicaid, Tricare any other state or federal government health care programs, and any other public or private third party payor programs (collectively, “Programs”) and is a party to valid participation agreements for payment by such Programs, except as could not reasonably be expected to have a Material Adverse Effect. Except as set forth on Schedule 5.26(c), there is no investigation, audit, claim review, or other action pending or, to the knowledge of the Borrower, threatened which could result in a revocation, suspension, termination, probation, material restriction, material limitation, or non-renewal of any Program participation agreement or result in the Borrowers or any of its Subsidiaries exclusion from any Program, except as could not reasonably be expected to have a Material Adverse Effect. Schedule 5.26(c) sets forth an accurate, complete and current list of (i) all Medicaid, Tricare and other state and federal government health care program participation agreements, or, in the case of Medicare, each provider number, and (ii) the top twenty-five (25) payors, by revenue, in each case, of the Borrower and its Subsidiaries, on a consolidated basis, as of the Closing Date.
(d) None of the Borrower, any of its Subsidiaries, or their respective officers, directors and, to the Borrowers knowledge, employees, agents and contractors has been or is currently excluded from participation in government health care programs pursuant to 42 U.S.C. § 1320a-7; except (i) as set forth on Schedule 5.26(d) and (ii) with respect to employees, agents or contractors, where exclusion from participation in such government health programs could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(eb) Except as set forth on Schedule 5.26(e)Borrower will, as and will cause each other Loan Party 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 all applicable Services, except to the extent such failure to keep in full force and effect or maintain would not reasonably be expected to have a Material Adverse Effect.
(ii) Promptly furnish or cause to be furnished to the Agent, to the extent such matters would reasonably be expected to have a Material Adverse Effect, (w) copies of all reports of investigational/inspectional observations issued to and received by the Closing Date, none of the Borrower Loan Parties or any of its their Subsidiaries, and issued by any Governmental Authority relating to such Person’s business, (x) copies of all FDA Form-483s and comparable inspectional observations and reports issued to and received by Loan Parties or any hospice that is not a Subsidiary but is operated of their Subsidiaries and issued by Borrower or a Subsidiary (i) is a party to a corporate integrity agreement, (ii) has any reporting obligations pursuant to a settlement agreement, plan of correction, or other remedial measure entered into with any Governmental Authority, (y) copies of all material warning letters and material untitled letters as well as other material documents received by Loan Parties or (iii) has been served with or received any search warrantof their Subsidiaries from the FDA, subpoena, civil investigative demand or contact letterCMS, or received any 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, directive or regulation of similar import and (z) notice of any material investigation or material audit or similar proceeding by the FDA, CMS, or any other Governmental Authority (other than routine audits conducted in the ordinary course of business).
(iii) from 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 Agency related to its business operations. The Borrower and each Authority under any Health Care Law against any Loan Party or any of its Subsidiaries, as applicable, has complied in .
(v) Promptly furnish or cause to be furnished to the Agent notice of all material respects with the terms and conditions allegations by any Governmental Authority (or any agent thereof) of fraudulent activities of any corporate integrity agreementsLoan 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, settlement agreementsno Loan Party or any of its Subsidiaries shall be required to furnish to Agent or any Lender patient-related or other information, plans the disclosure of correction, other remedial measures, search warrants, subpoenas, civil investigative demands, which to Agent or contract letters set forth on Schedule 5.26(e)such Lender is prohibited by any applicable law.
Appears in 1 contract
Samples: Credit Agreement (Elutia Inc.)
Compliance with Health Care Laws. Without limiting the generality of any other representation and warranty contained herein:
(a) Except as could would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, each of the Borrower, its Subsidiaries, and their respective officers, directors, employees, agents and contractors (exercising their respective duties on behalf of the Borrower or any of its Subsidiaries) and each hospice that is not a Subsidiary operated by the Borrower or a Subsidiary is, and within the last six years has been, in compliance with all relevant Health Care Laws, and, with respect to the civil monetary penalty law (42 U.S.C. § 1320a-7a), none of them has engaged in any conduct that would result in a material violation of any law or regulation for which penalties could be imposed under 42 U.S.C. § 1320a-7a.
(b) Except as set forth on Schedule 5.26(b) and except as could would not, individually or in the aggregate reasonably be expected to have a Material Adverse Effect, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by the Borrower or a Subsidiary has (i) all licenses, consents, certificates, permits, authorizations, approvals, franchises, registrations, certificates of need, accreditations, and other rights from, and has made all declarations and filings with, all applicable Governmental Authorities Authorities, Medicare Administrative Contractors and accrediting organizations (each, a “Health Care Permit”) necessary to operate its business, and (ii) not received notice and has no knowledge that any Governmental Authority Authority, Medicare Administrative Contractor or accreditation organization is considering limiting, suspending, terminating, or revoking any such Health Care Permit. All such Health Care Permits are valid and in full force and effect, except as could would not reasonably be expected to have a Material Adverse Effect, and the Borrower and each of its Subsidiaries and each hospice that is not a Subsidiary but is operated by the Borrower or a Subsidiary is in material compliance with the terms and conditions of all such Health Care Permits and with the rules and regulations of the Governmental Authorities Authorities, Medicare Administrative Contractors and accrediting organizations having jurisdiction with respect to such Health Care Permits.
(c) To the extent it participates in a particular Program, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by the Borrower or a Subsidiary meets all of the requirements of participation and payment of Medicare, Medicaid, Tricare any other state or federal government health care programs, and any other public or private third party payor programs (collectively, “Programs”) and is a party to valid participation agreements for payment by such Programs, except as could would not reasonably be expected to have a Material Adverse Effect. Except as set forth on Schedule 5.26(c), there is no investigation, audit, claim review, or other action pending or, to the knowledge of the Borrower, threatened which could result in a revocation, suspension, termination, probation, material restriction, material limitation, or non-renewal of any Program participation agreement or result in the Borrowers Borrower or any of its Subsidiaries exclusion from any Program, except as could would not reasonably be expected to have a Material Adverse Effect. Schedule 5.26(c) sets forth an accurate, complete and current list of (i) all Medicaid, Tricare and other state and federal government health care program participation agreements, or, in the case of Medicare, each provider number, and (ii) the top twenty-five (25) payors, by revenue, in each case, of the Borrower and its Subsidiaries, on a consolidated basis, as of the Closing Date.
(d) None of the Borrower, any of its Subsidiaries, or their respective officers, directors and, to the Borrowers Borrower’s knowledge, employees, agents and contractors has been or is currently excluded from participation in government health care programs pursuant to 42 U.S.C. § 1320a-7; except (i) as set forth on Schedule 5.26(d) and (ii) with respect to employees, agents or contractors, where exclusion from participation in such government health programs could would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(e) Except as set forth on Schedule 5.26(e), as of the Closing Date, none of the Borrower or any of its Subsidiaries, or any hospice that is not a Subsidiary but is operated by the Borrower or a Subsidiary (i) is a party to a corporate integrity agreement, (ii) has any reporting obligations pursuant to a settlement agreement, plan of correction, or other remedial measure entered into with any Governmental AuthorityAuthority or any Medicare Administrative Contractor, or (iii) has been served with or received any search warrant, subpoena, civil investigative demand or contact letter, or received notice of any audit (other than routine audits in the ordinary course of business) from any Governmental Agency Authority or any Medicare Administrative Contractor related to its business operations. The Borrower and each of its Subsidiaries, as applicable, has complied in all material respects with the terms and conditions of any corporate integrity agreements, settlement agreements, plans of correction, other remedial measures, search warrants, subpoenas, civil investigative demands, or contract letters set forth on Schedule 5.26(e).
Appears in 1 contract
Compliance with Health Care Laws. Without limiting the generality of any other representation and warranty contained herein:
(a) Except The Company and its Subsidiaries, when taken as could nota whole, individually are in compliance in all material respects with all material Health Care Laws applicable to it, its products and its properties or other assets or its business or operation. Each of the Company and its 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 the aggregateCompany nor any of its 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 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 Effect, each of Borrower, its Subsidiaries, and their respective officers, directors, employees, agents and contractors (exercising their respective duties on behalf of the Borrower or any of its Subsidiaries) and each hospice that is not a Subsidiary operated by Borrower or a Subsidiary is, and within the last six years has been, in compliance with all relevant Health Care Laws, and, with respect to the civil monetary penalty law (42 U.S.C. § 1320a-7a), none of them has engaged in any conduct that would result in a material violation of any law or regulation for which penalties could be imposed under 42 U.S.C. § 1320a-7a.
(b) Except as set forth on Schedule 5.26(b) and except as could not5.22, individually all reports, documents, claims, notices or in approvals required to be filed, obtained, maintained or furnished by the aggregate reasonably be expected to have a Material Adverse Effect, each of the Borrower Company and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary has (i) all licenses, consents, certificates, permits, authorizations, approvals, franchises, registrations, certificates of need, accreditations, and other rights from, and has made all declarations and filings with, all applicable Governmental Authorities and accrediting organizations (each, a “pursuant to any Health Care Permit”) necessary Law to operate its business, and (ii) not received notice and has no knowledge that any Governmental Authority have been so filed, obtained, maintained or accreditation organization is considering limiting, suspending, terminating, or revoking any such Health Care Permit. All such Health Care Permits are valid and in full force and effect, furnished except as could where the failure to do so would not reasonably be expected to have a Material Adverse Effect, and the Borrower and each of its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary is in material compliance with the terms and conditions of all such Health Care Permits reports, documents, claims and with notices were complete and correct in all material respects on the rules and regulations of the Governmental Authorities and accrediting organizations having jurisdiction with respect to such Health Care Permitsdate filed (or were or will be corrected in or supplemented by a subsequent filing).
(c) To Each of the Company and its Subsidiaries, to the extent that it participates in a particular Programis billing the applicable Third Party Payor, each of has the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower requisite provider number or a Subsidiary meets all of the requirements of participation and payment of other Governmental Authorization to xxxx under Medicare, Medicaidthe respective Medicaid program in the state or states in which such entity operates, Tricare any other state or federal government health care programs, Governmental Third Party Payor Program and any other public or private third party payor programs (collectively, “Private Third Party Payor Programs”) and is a party to valid participation agreements for payment by such Programs, except as could not reasonably be expected to have a Material Adverse Effect. Except as set forth on Schedule 5.26(c), there There is no investigation, audit, claim review, or other action pending orpending, or threatened to the knowledge of the BorrowerCompany or its Subsidiaries, threatened which could would result in a revocation, suspension, termination, probation, material restriction, material limitation, or non-renewal of any Program participation agreement Governmental Third Party Payor or Private Third Party Payor provider number or result in any of the Borrowers Company’s or any of its Subsidiaries Subsidiaries’ exclusion from any ProgramGovernmental Third Party Payor Program or Private Third Party Payor Program which individually or in the aggregate, except as could not would reasonably be expected to have a Material Adverse Effect. Schedule 5.26(c) sets forth an accurateFor purposes of this Agreement, complete and current list of (i) all a “Governmental Third Party Payor” means Medicare, Medicaid, Tricare and other state and TRICARE, federal government health care program participation agreements, or, in the case of Medicare, each provider number, and (ii) the top twenty-five (25) payors, by revenue, in each case, of the Borrower and its Subsidiaries, on a consolidated basis, as of the Closing Date.
(d) None of the Borrower, any of its Subsidiaries, or their respective officers, directors and, to the Borrowers knowledge, employees, agents and contractors has been or is currently excluded from participation in government health care programs pursuant to 42 U.S.C. § 1320a-7; except (i) as set forth on Schedule 5.26(d) and (ii) with respect to employees, agents or contractors, where exclusion from participation in such government health programs could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(e) Except as set forth on Schedule 5.26(e), as of the Closing Date, none of the Borrower or any of its Subsidiaries, or any hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary (i) is a party to a corporate integrity agreement, (ii) has any reporting obligations pursuant to a settlement agreement, plan of correction, or other remedial measure entered into with any Governmental Authority, or (iii) has been served with or received any search warrant, subpoena, civil investigative demand or contact letter, or received notice of any audit (other than routine audits in the ordinary course of business) from any Governmental Agency related to its business operations. The Borrower and each of its Subsidiaries, as applicable, has complied in all material respects with the terms and conditions of any corporate integrity agreements, settlement agreements, plans of correction, other remedial measures, search warrants, subpoenas, civil investigative demands, or contract letters set forth on Schedule 5.26(e).state
Appears in 1 contract
Samples: Credit Agreement (Amedisys Inc)
Compliance with Health Care Laws. Without limiting the generality of Section 4.3(d) or any other representation or warranty made herein, to the Borrower's knowledge, the health care facilities, providers, suppliers and warranty contained herein:
other businesses owned or operated by the Borrower and its Subsidiaries (acollectively, the "Health Care Facilities"), and each of their respective licensed employees and independent contractors in the exercise of their respective duties on behalf of such Health Care Facilities, are in compliance with all applicable Health Care Laws (including without limitation Section 1128B(b) Except of the Social Security Act, as amended, 42 U.S.C. Section 1320a-7(b) (Criminal Penalties Involving Medicare or State Health Care Programs), commonly referred to as the "Federal Anti-Kickback Statute," and the Social Security Act, as amended, Section 1877, 42 U.S.C. Section 1395nn (Prohibition Against Certain Referrals), commonly referred to as "Xxxxx Statute") except to the extent that the failure to comply therewith could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, each of Borrower, its Subsidiaries, and their respective officers, directors, employees, agents and contractors (exercising their respective duties on behalf of the Borrower or any of its Subsidiaries) and each hospice that is not a Subsidiary operated by Borrower or a Subsidiary is, and within the last six years has been, in compliance with all relevant Health Care Laws, and, with respect to the civil monetary penalty law (42 U.S.C. § 1320a-7a), none of them has engaged in any conduct that would result in a material violation of any law or regulation for which penalties could be imposed under 42 U.S.C. § 1320a-7a.
(b) Except as set forth on Schedule 5.26(b) and except as could not, individually or in the aggregate reasonably be expected to have a Material Adverse Effect, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary has (i) all licenses, consents, certificates, permits, authorizations, approvals, franchises, registrations, certificates of need, accreditations, and other rights from, and has made all declarations and filings with, all applicable Governmental Authorities and accrediting organizations (each, a “Health Care Permit”) necessary to operate its business, and (ii) not received notice and has no knowledge that any Governmental Authority or accreditation organization is considering limiting, suspending, terminating, or revoking any such Health Care Permit. All such Health Care Permits are valid and in full force and effect, except as could not reasonably be expected to have a Material Adverse Effect, and the The Borrower and each of its Subsidiaries have maintained in all material respects all records required to be maintained by the Joint Commission on Accreditation of Healthcare Organizations (if applicable), any Governmental Authority and each hospice that is not a Subsidiary but is operated the federal Medicare and state Medicaid programs as required by Borrower or a Subsidiary is in material compliance with the terms and conditions of all such Health Care Permits and with the rules and regulations of the Governmental Authorities and accrediting organizations having jurisdiction with respect to such Health Care Permits.
(c) To the extent it participates in a particular Program, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary meets all of the requirements of participation and payment of Medicare, Medicaid, Tricare any other state or federal government health care programs, and any other public or private third party payor programs (collectively, “Programs”) and is a party to valid participation agreements for payment by such Programs, except as could not reasonably be expected to have a Material Adverse Effect. Except as set forth on Schedule 5.26(c), there is no investigation, audit, claim review, or other action pending orLaws and, to the knowledge of the Borrower, threatened there are no presently existing circumstances or violations of Health Care Laws which could are, in the aggregate, reasonably likely to result in a revocation, suspension, termination, probation, material restriction, material limitation, or non-renewal of any Program participation agreement or result in the Borrowers or any of its Subsidiaries exclusion from any Program, except as could not reasonably be expected to have a Material Adverse Effect. Schedule 5.26(c) sets forth an accurate, complete and current list of (i) all Medicaid, Tricare and other state and federal government health care program participation agreements, or, in the case of Medicare, each provider number, and (ii) the top twenty-five (25) payors, by revenue, in each case, of the The Borrower and its SubsidiariesSubsidiaries and the owners of the Health Care Facilities operated or managed by the Borrower or its Subsidiaries have such permits, on a consolidated basislicenses, franchises, certificates, provider agreements and other approvals or authorizations (collectively "Governmental Approvals") of Governmental Authorities as are necessary under applicable law to own their respective properties and to conduct their respective business (including without limitation Government Approvals as are necessary to xxxx the Medicare, Medicaid and other governmental programs, and under such HMO or similar licensure laws and such insurance laws and regulations, as of the Closing Date.
(dare applicable thereto) None of the Borrower, any of its Subsidiaries, or their respective officers, directors and, except to the Borrowers knowledge, employees, agents and contractors has been extent that the failure to obtain or is currently excluded from participation in government health care programs pursuant to 42 U.S.C. § 1320a-7; except (i) as set forth on Schedule 5.26(d) and (ii) with respect to employees, agents possess such Governmental Approvals or contractors, where exclusion from participation in such government health programs authorizations could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(e) Except as set forth on Schedule 5.26(e). There are no proceedings pending or, as of to the Closing DateBorrower's knowledge, none threatened by any Governmental Authority seeking to modify, revoke or suspend such Governmental Approvals. None of the Borrower or any of its Subsidiaries, or Subsidiary has taken any hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary (i) is a party action with respect to a corporate integrity agreement, (ii) has any reporting obligations pursuant to a settlement agreement, plan of correction, or other remedial measure entered into with any Governmental Authority, or (iii) has been served with or received any search warrant, subpoena, civil investigative demand or contact letter, or received notice of any audit (other than routine audits in the ordinary course of business) from any Governmental Agency related to its business operations. The Borrower and each of its Subsidiaries, as applicable, has complied in all material respects with the terms and conditions of any corporate integrity agreements, settlement agreements, plans of correction, other remedial measures, search warrants, subpoenas, civil investigative demands, or contract letters set forth on Schedule 5.26(e)Facility that would materially adversely affect such Government Approvals.
Appears in 1 contract
Compliance with Health Care Laws. Without limiting the generality of any other representation and warranty contained herein:
(a) Except The Company and its Subsidiaries, when taken as could nota whole, individually are in compliance in all material respects with all material Health Care Laws applicable to it, its products and its properties or other assets or its business or operation. Each of the Company and its 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 the aggregateCompany nor any of its 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 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 Effect, each of Borrower, its Subsidiaries, and their respective officers, directors, employees, agents and contractors (exercising their respective duties on behalf of the Borrower or any of its Subsidiaries) and each hospice that is not a Subsidiary operated by Borrower or a Subsidiary is, and within the last six years has been, in compliance with all relevant Health Care Laws, and, with respect to the civil monetary penalty law (42 U.S.C. § 1320a-7a), none of them has engaged in any conduct that would result in a material violation of any law or regulation for which penalties could be imposed under 42 U.S.C. § 1320a-7a.
(b) Except as set forth on Schedule 5.26(b) and except as could not5.22, individually all reports, documents, claims, notices or in approvals required to be filed, obtained, maintained or furnished by the aggregate reasonably be expected to have a Material Adverse Effect, each of the Borrower Company and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary has (i) all licenses, consents, certificates, permits, authorizations, approvals, franchises, registrations, certificates of need, accreditations, and other rights from, and has made all declarations and filings with, all applicable Governmental Authorities and accrediting organizations (each, a “pursuant to any Health Care Permit”) necessary Law to operate its business, and (ii) not received notice and has no knowledge that any Governmental Authority have been so filed, obtained, maintained or accreditation organization is considering limiting, suspending, terminating, or revoking any such Health Care Permit. All such Health Care Permits are valid and in full force and effect, furnished except as could where the failure to do so would not reasonably be expected to have a Material Adverse Effect, and the Borrower and each of its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary is in material compliance with the terms and conditions of all such Health Care Permits reports, documents, claims and with notices were complete and correct in all material respects on the rules and regulations of the Governmental Authorities and accrediting organizations having jurisdiction with respect to such Health Care Permitsdate filed (or were or will be corrected in or supplemented by a subsequent filing).
(c) To Each of the Company and its Subsidiaries, to the extent that it participates in a particular Programis billing the applicable Third Party Payor, each of has the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower requisite provider number or a Subsidiary meets all of the requirements of participation and payment of other Governmental Authorization to bill under Medicare, Medicaidthe respective Medicaid program in the state or states in which such entity operates, Tricare any other state or federal government health care programs, Governmental Third Party Payor Program and any other public or private third party payor programs (collectively, “Private Third Party Payor Programs”) and is a party to valid participation agreements for payment by such Programs, except as could not reasonably be expected to have a Material Adverse Effect. Except as set forth on Schedule 5.26(c), there There is no investigation, audit, claim review, or other action pending orpending, or threatened to the knowledge of the BorrowerCompany or its Subsidiaries, threatened which could would result in a revocation, suspension, termination, probation, material restriction, material limitation, or non-renewal nonrenewal of any Program participation agreement Governmental Third Party Payor or Private Third Party Payor provider number or result in any of the Borrowers Company’s or any of its Subsidiaries Subsidiaries’ exclusion from any ProgramGovernmental Third Party Payor Program or Private Third Party Payor Program which individually or in the aggregate, except as could not would reasonably be expected to have a Material Adverse Effect. Schedule 5.26(c) sets forth an accurateFor purposes of this Agreement, complete and current list of (i) all a “Governmental Third Party Payor” means Medicare, Medicaid, Tricare and other TRICARE, federal or state and federal government health care program participation agreements, or, in the case of Medicare, each provider number, and (ii) the top twenty-five (25) payors, by revenue, in each case, of the Borrower and its Subsidiaries, on a consolidated basis, as of the Closing Date.
(d) None of the Borrower, any of its Subsidiaries, insurers or their respective officers, directors and, to the Borrowers knowledge, employees, agents and contractors has been or is currently excluded from participation in government health care programs pursuant to 42 U.S.C. § 1320a-7; except (i) as set forth on Schedule 5.26(d) and (ii) with respect to employees, agents any other person or contractors, where exclusion from participation in such government health programs could not, individually entity which presently or in the aggregatefuture maintains Governmental Third Party Payor Programs. In addition, reasonably be expected to have a Material Adverse Effect.
(e) Except as set forth on Schedule 5.26(e)for purposes of this Agreement, as of “Governmental Third Party Payor Programs” means all governmental third party payor programs in which the Closing Date, none of the Borrower Company or any of its SubsidiariesSubsidiaries participates (including 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 Company or any of its Subsidiaries participate (including managed care plans, or any hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary (i) is a party to a corporate integrity agreement, (ii) has any reporting obligations pursuant to a settlement agreement, plan of correction, or other remedial measure entered into with any Governmental Authority, or (iii) has been served with or received any search warrant, subpoena, civil investigative demand or contact letter, or received notice of any audit (other than routine audits in the ordinary course of business) from any Governmental Agency related to its business operations. The Borrower and each of its Subsidiaries, as applicable, has complied in all material respects with the terms and conditions of any corporate integrity agreements, settlement agreements, plans of correction, other remedial measures, search warrants, subpoenas, civil investigative demands, or contract letters set forth on Schedule 5.26(eprivate health care insurance programs).
Appears in 1 contract
Samples: Credit Agreement (Amedisys Inc)
Compliance with Health Care Laws. Without limiting the generality of subsection 4.17 or any other representation and or warranty contained made herein:
(a) Except as could not, individually or in the aggregate, reasonably be expected to have a Material Adverse EffectBorrowers' knowledge, each of Borrower, its Subsidiariesthe Facilities, and their respective officers, directors, employees, agents each of its licensed employees and contractors (exercising other than contracted agencies) in the exercise of their respective duties on behalf of the Borrower or any of its Subsidiaries) and each hospice that is not a Subsidiary operated by Borrower or a Subsidiary is, and within the last six years has been, in compliance with all relevant Health Care Laws, and, with respect to the civil monetary penalty law (42 U.S.C. § 1320a-7a), none of them has engaged in any conduct that would result in a material violation of any law or regulation for which penalties could be imposed under 42 U.S.C. § 1320a-7a.
(b) Except as set forth on Schedule 5.26(b) and except as could not, individually or in the aggregate reasonably be expected to have a Material Adverse Effect, each of the Borrower and its Subsidiaries and each hospice that Facilities, is not a Subsidiary but is operated by Borrower or a Subsidiary has (i) in compliance in all licenses, consents, certificates, permits, authorizations, approvals, franchises, registrations, certificates of need, accreditations, and other rights from, and has made all declarations and filings with, material respects with all applicable Governmental Authorities and accrediting organizations (eachstatutes, a “Health Care Permit”) necessary to operate its businesslaws, and (ii) not received notice and has no knowledge that any Governmental Authority or accreditation organization is considering limitingordinances, suspending, terminating, or revoking any such Health Care Permit. All such Health Care Permits are valid and in full force and effect, except as could not reasonably be expected to have a Material Adverse Effect, and the Borrower and each of its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary is in material compliance with the terms and conditions of all such Health Care Permits and with the rules and regulations of any Governmental Authority (including without limitation Section 1128B(b) of the Governmental Authorities and accrediting organizations having jurisdiction with respect to such Social Security Act, as amended, 42 U.S.C. Section 1320a-7(b) (Criminal Penalties Involving Medicare or State Health Care Permits.
Programs), commonly referred to as the "Federal Anti-Kickback Statute," and the Social Security Act, Section 1877, (c) To the extent it participates in a particular ProgramProhibition Against Certain Referrals), each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary meets all of the requirements of participation and payment of Medicare, Medicaid, Tricare any other state or federal government health care programs, and any other public or private third party payor programs commonly referred to as "Sxxxx Statute" (collectively, “Programs”) "Healthcare Laws")). Borrowers have maintained in all material respects all records required to be maintained by the Joint Commission on Accreditation of Healthcare Organizations, the Food and is a party Drug Administration, the Drug Enforcement Agency, the State Boards of Pharmacy and, to valid participation agreements for payment the extent required by such ProgramsHealthcare Laws, except as could not reasonably be expected to have a Material Adverse Effect. Except as set forth on Schedule 5.26(c)the federal and state Medicare, there is no investigation, audit, claim review, or other action pending orMedicaid and TRICARE programs and, to the knowledge of the BorrowerBorrowers, threatened there are no presently existing circumstances which could would result or likely would result in a revocation, suspension, termination, probation, material restriction, material limitation, or non-renewal of any Program participation agreement or result in the Borrowers or any of its Subsidiaries exclusion from any Program, except as could not reasonably be expected to have a Material Adverse Effect. Schedule 5.26(c) sets forth an accurate, complete and current list of (i) all Medicaid, Tricare and other state and federal government health care program participation agreements, or, in the case of Medicare, each provider number, and (ii) the top twenty-five (25) payors, by revenue, in each case, violations of the Healthcare Laws. Each Borrower and its SubsidiariesAffiliates and the owners of the facilities and other businesses managed by any Borrower or its Affiliates have such permits, on a consolidated basislicenses, franchises, certificates and other approvals or authorizations of governmental or regulatory authorities as are necessary under applicable law to own their respective properties and to conduct their respective business (including without limitation such permits as are required under such federal, state and other health care laws, and under such HMO or similar licensure laws and such insurance laws and regulations, as of the Closing Date.
(d) None of the Borrowerare applicable thereto), any of its Subsidiaries, or their respective officers, directors and, to the Borrowers knowledge, employees, agents and contractors has been or is currently excluded from participation in government health care programs pursuant to 42 U.S.C. § 1320a-7; except (i) as set forth on Schedule 5.26(d) and (ii) with respect to employeesthose facilities and other businesses that participate in Medicare, agents Medicaid and/or TRICARE to receive reimbursement under Medicare, Medicaid and TRICARE. There currently exist no restrictions, deficiencies, required plans of corrective actions or contractorsother such remedial measures with respect to federal and state Medicare, where exclusion from participation in such government health programs Medicaid and TRICARE certifications or licensure that could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(e) Except as set forth on Schedule 5.26(e), as of the Closing Date, none of the Borrower or any of its Subsidiaries, or any hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary (i) is a party to a corporate integrity agreement, (ii) has any reporting obligations pursuant to a settlement agreement, plan of correction, or other remedial measure entered into with any Governmental Authority, or (iii) has been served with or received any search warrant, subpoena, civil investigative demand or contact letter, or received notice of any audit (other than routine audits in the ordinary course of business) from any Governmental Agency related to its business operations. The Borrower and each of its Subsidiaries, as applicable, has complied in all material respects with the terms and conditions of any corporate integrity agreements, settlement agreements, plans of correction, other remedial measures, search warrants, subpoenas, civil investigative demands, or contract letters set forth on Schedule 5.26(e).
Appears in 1 contract
Samples: Loan and Security Agreement (Sun Healthcare Group Inc)
Compliance with Health Care Laws. Without limiting the generality of any other provision that is set forth herein (including, without limitation, any covenant, representation or warranty), the Borrower and warranty contained herein:
each of its Subsidiaries, and each of the Borrower’s and each Subsidiary’s employees and contractors in the exercise of their respective duties on behalf of the Borrower, any such Subsidiary or any facilities where such licensed employees and contractors perform services on behalf of customers of the Borrower or any Subsidiary, is in compliance in all respects with all applicable statutes, laws, ordinances, rules and regulations of any federal, state or local governmental authority with respect to regulatory matters primarily relating to patient healthcare (a) Except collectively, “Healthcare Laws”), except where non-compliance, either individually or in the aggregate, could not reasonably be expected to result in a Material Adverse Effect. The Borrower and each of its Subsidiaries has maintained in all material respects all records required to be maintained by the Healthcare Laws and, to the knowledge of the Loan Parties, there are no presently existing circumstances which would result or likely would result in violations of the Healthcare Laws, except where such violations, either individually or in the aggregate, could not reasonably be expected to result in a Material Adverse Effect. The Borrower and its Subsidiaries and, to the Loan Parties’ knowledge, the owners of other businesses managed by the Borrower or its Subsidiaries have such permits, licenses, franchises, certificates and other approvals or authorizations of Governmental Authorities as could notare necessary under applicable Healthcare Laws to own their respective properties and to conduct their respective business (including without limitation such permits as are required under such federal, state and other health care laws, and under licensure laws and such insurance laws and regulations, as are applicable thereto), except where the failure to have such permits, licenses, franchises, certificates and other approvals or authorizations of Governmental Authorities, individually or in the aggregate, could not reasonably be expected to have result in a Material Adverse Effect. In addition, each such employee and contractor holds, without restriction, such permits, licenses, franchises, certificates and other approvals or authorizations of Borrower, its Subsidiaries, Governmental Authorities as are necessary under applicable Healthcare Laws to perform services on behalf of any customer of the Borrower or any Subsidiary in the exercise of such employees’ and their respective officers, directors, employees, agents and contractors (exercising their contractors’ respective duties on behalf of the Borrower or any of its Subsidiaries) and each hospice that is not a Subsidiary operated by Borrower or a Subsidiary issuch Subsidiary, and within except where the last six years has been, in compliance with all relevant Health Care Laws, and, with respect to the civil monetary penalty law (42 U.S.C. § 1320a-7a), none of them has engaged in any conduct that would result in a material violation of any law or regulation for which penalties could be imposed under 42 U.S.C. § 1320a-7a.
(b) Except as set forth on Schedule 5.26(b) and except as could not, individually or in the aggregate reasonably be expected failure to have a Material Adverse Effect, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary has (i) all licenses, consents, certificates, such permits, authorizations, approvalslicenses, franchises, registrations, certificates of need, accreditations, and other rights from, and has made all declarations and filings with, all applicable approvals or authorizations of Governmental Authorities and accrediting organizations (each, a “Health Care Permit”) necessary to operate its business, and (ii) not received notice and has no knowledge that any Governmental Authority or accreditation organization is considering limiting, suspending, terminating, or revoking any such Health Care Permit. All such Health Care Permits are valid and in full force and effect, except as could not reasonably be expected to have a Material Adverse Effect, and the Borrower and each of its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary is in material compliance with the terms and conditions of all such Health Care Permits and with the rules and regulations of the Governmental Authorities and accrediting organizations having jurisdiction with respect to such Health Care Permits.
(c) To the extent it participates in a particular Program, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary meets all of the requirements of participation and payment of Medicare, Medicaid, Tricare any other state or federal government health care programs, and any other public or private third party payor programs (collectively, “Programs”) and is a party to valid participation agreements for payment by such Programs, except as could not reasonably be expected to have a Material Adverse Effect. Except as set forth on Schedule 5.26(c), there is no investigation, audit, claim review, or other action pending or, to the knowledge of the Borrower, threatened which could result in a revocation, suspension, termination, probation, material restriction, material limitation, or non-renewal of any Program participation agreement or result in the Borrowers or any of its Subsidiaries exclusion from any Program, except as could not reasonably be expected to have a Material Adverse Effect. Schedule 5.26(c) sets forth an accurate, complete and current list of (i) all Medicaid, Tricare and other state and federal government health care program participation agreements, or, in the case of Medicare, each provider number, and (ii) the top twenty-five (25) payors, by revenue, in each case, of the Borrower and its Subsidiaries, on a consolidated basis, as of the Closing Date.
(d) None of the Borrower, any of its Subsidiaries, or their respective officers, directors and, to the Borrowers knowledge, employees, agents and contractors has been or is currently excluded from participation in government health care programs pursuant to 42 U.S.C. § 1320a-7; except (i) as set forth on Schedule 5.26(d) and (ii) with respect to employees, agents or contractors, where exclusion from participation in such government health programs could notAuthorities, individually or in the aggregate, could not reasonably be expected to have result in a Material Adverse Effect.
(e) Except as set forth . Further, each such employee and contractor, if required by the applicable facility where such employee or contractor performs services on Schedule 5.26(e), as of the Closing Date, none behalf of the Borrower or any Subsidiary, holds unrestricted medical staff privileges to perform professional services at such facility, except where such failure to maintain medical staff privileges could not reasonably be expected to result in a Material Adverse Effect. Neither the Borrower nor any of its SubsidiariesSubsidiaries are enrolled in, xxxx to or receive any reimbursement from third party payors, including without limitation, Medicare, Medicaid, or any hospice that is not a Subsidiary but is operated by Borrower other federal, state, or a Subsidiary other government or commercial health care program. Neither the Borrower, any Subsidiary, or any of their respective employees or independent contractors: (i) is have been convicted of a party criminal offense related to a corporate integrity agreement, healthcare (unless such individual has been officially reinstated into the federal healthcare programs by the U.S. Department of Health and Human Services Office of Inspector General (“OIG”); (ii) has are currently under sanction, exclusion or investigation (civil or criminal) by any reporting obligations pursuant to a settlement agreementfederal or state enforcement, plan of correctionregulatory, administrative or other remedial measure entered into with any Governmental Authority, licensing agency or is ineligible for federal or state program participation; or (iii) has been served with are currently listed on the General Services Administration List of Parties Excluded from the Federal Procurement and Non-Procurement Programs or received any search warrant, subpoena, civil investigative demand or contact letter, or received notice the OIG List of any audit (other than routine audits in the ordinary course of business) from any Governmental Agency related to its business operations. The Borrower and each of its Subsidiaries, as applicable, has complied in all material respects with the terms and conditions of any corporate integrity agreements, settlement agreements, plans of correction, other remedial measures, search warrants, subpoenas, civil investigative demands, or contract letters set forth on Schedule 5.26(e)Excluded Individuals/Entities.
Appears in 1 contract
Compliance with Health Care Laws. Without limiting the generality of any other representation and warranty contained herein:
(a) Except The Company and its Subsidiaries, when taken as could nota whole, individually are in compliance in all material respects with all material Health Care Laws applicable to it, its products and its properties or other assets or its business or operation. Each of the Company and its 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 the aggregateCompany nor any of its 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 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 Effect, each of Borrower, its Subsidiaries, and their respective officers, directors, employees, agents and contractors (exercising their respective duties on behalf of the Borrower or any of its Subsidiaries) and each hospice that is not a Subsidiary operated by Borrower or a Subsidiary is, and within the last six years has been, in compliance with all relevant Health Care Laws, and, with respect to the civil monetary penalty law (42 U.S.C. § 1320a-7a), none of them has engaged in any conduct that would result in a material violation of any law or regulation for which penalties could be imposed under 42 U.S.C. § 1320a-7a.
(b) Except as set forth on Schedule 5.26(b) and except as could not5.22, individually all reports, documents, claims, notices or in approvals required to be filed, obtained, maintained or furnished by the aggregate reasonably be expected to have a Material Adverse Effect, each of the Borrower Company and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary has (i) all licenses, consents, certificates, permits, authorizations, approvals, franchises, registrations, certificates of need, accreditations, and other rights from, and has made all declarations and filings with, all applicable Governmental Authorities and accrediting organizations (each, a “pursuant to any Health Care Permit”) necessary Law to operate its business, and (ii) not received notice and has no knowledge that any Governmental Authority have been so filed, obtained, maintained or accreditation organization is considering limiting, suspending, terminating, or revoking any such Health Care Permit. All such Health Care Permits are valid and in full force and effect, furnished except as could where the failure to do so would not reasonably be expected to have a Material Adverse Effect, and the Borrower and each of its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary is in material compliance with the terms and conditions of all such Health Care Permits reports, documents, claims and with notices were complete and correct in all material respects on the rules and regulations of the Governmental Authorities and accrediting organizations having jurisdiction with respect to such Health Care Permitsdate filed (or were or will be corrected in or supplemented by a subsequent filing).
(c) To the extent it participates in a particular Program, each Each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary meets all of the requirements of participation and payment of Medicare, Medicaid, Tricare any other state or federal government health care programs, and any other public or private third party payor programs (collectively, “Programs”) and is a party to valid participation agreements for payment by such Programs, except as could not reasonably be expected to have a Material Adverse Effect. Except as set forth on Schedule 5.26(c), there is no investigation, audit, claim review, or other action pending or, to the knowledge of the Borrower, threatened which could result in a revocation, suspension, termination, probation, material restriction, material limitation, or non-renewal of any Program participation agreement or result in the Borrowers or any of its Subsidiaries exclusion from any Program, except as could not reasonably be expected to have a Material Adverse Effect. Schedule 5.26(c) sets forth an accurate, complete and current list of (i) all Medicaid, Tricare and other state and federal government health care program participation agreements, or, in the case of Medicare, each provider number, and (ii) the top twenty-five (25) payors, by revenue, in each case, of the Borrower Company and its Subsidiaries, on a consolidated basis, as of the Closing Date.
(d) None of the Borrower, any of its Subsidiaries, or their respective officers, directors and, to the Borrowers knowledgeextent that it is billing the applicable Third Party Payor, employees, agents and contractors has been or is currently excluded from participation in government health care programs pursuant to 42 U.S.C. § 1320a-7; except (i) as set forth on Schedule 5.26(d) and (ii) with respect to employees, agents or contractors, where exclusion from participation in such government health programs could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(e) Except as set forth on Schedule 5.26(e), as of the Closing Date, none of the Borrower or any of its Subsidiaries, or any hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary (i) is a party to a corporate integrity agreement, (ii) has any reporting obligations pursuant to a settlement agreement, plan of correction, requisite provider number or other remedial measure entered into with any Governmental AuthorityAuthorization to xxxx under Medicare, or (iii) has been served with or received any search warrant, subpoena, civil investigative demand or contact letter, or received notice of any audit (other than routine audits in the ordinary course of business) from any Governmental Agency related to its business operations. The Borrower and each of its Subsidiaries, as applicable, has complied in all material respects with the terms and conditions of any corporate integrity agreements, settlement agreements, plans of correction, other remedial measures, search warrants, subpoenas, civil investigative demands, or contract letters set forth on Schedule 5.26(e).respective Medicaid
Appears in 1 contract
Samples: Credit Agreement (Amedisys Inc)
Compliance with Health Care Laws. Without limiting the generality of any other representation and warranty contained herein:
(a) Except as could notWithout limiting or qualifying Section 6.4 or any other provision of this Agreement, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, each of Borrower, its SubsidiariesBorrower will comply, and their respective officers, directors, employees, agents and contractors (exercising their respective duties on behalf of the Borrower or any of its Subsidiaries) will cause each other Loan Party and each hospice that is not a Subsidiary operated by of Borrower or a Subsidiary is, and within the last six years has beento comply, in compliance all material respects with all relevant applicable Health Care Laws, and, with respect Laws relating to the civil monetary penalty law (42 U.S.C. § 1320a-7a), none operation of them has engaged in any conduct that would result in a material violation of any law or regulation for which penalties could be imposed under 42 U.S.C. § 1320a-7a.
(b) Except as set forth on Schedule 5.26(b) and except as could not, individually or in the aggregate reasonably be expected to have a Material Adverse Effect, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary has (i) all licenses, consents, certificates, permits, authorizations, approvals, franchises, registrations, certificates of need, accreditations, and other rights from, and has made all declarations and filings with, all applicable Governmental Authorities and accrediting organizations (each, a “Health Care Permit”) necessary to operate its such Person’s business, and (ii) except where failure to comply would not received notice and has no knowledge that any Governmental Authority or accreditation organization is considering limiting, suspending, terminating, or revoking any such Health Care Permit. All such Health Care Permits are valid and in full force and effect, except as could not reasonably be expected to have a Material Adverse Effect, and the Borrower and each of its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary is in material compliance with the terms and conditions of all such Health Care Permits and with the rules and regulations of the Governmental Authorities and accrediting organizations having jurisdiction with respect to such Health Care Permits.
(c) To the extent it participates in a particular Program, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary meets all of the requirements of participation and payment of Medicare, Medicaid, Tricare any other state or federal government health care programs, and any other public or private third party payor programs (collectively, “Programs”) and is a party to valid participation agreements for payment by such Programs, except as could not reasonably be expected to have a Material Adverse Effect. Except as set forth on Schedule 5.26(c), there is no investigation, audit, claim review, or other action pending or, to the knowledge of the Borrower, threatened which could result in a revocation, suspension, termination, probation, material restriction, material limitation, or non-renewal of any Program participation agreement or result in the Borrowers or any of its Subsidiaries exclusion from any Program, except as could not reasonably be expected to have a Material Adverse Effect. Schedule 5.26(c) sets forth an accurate, complete and current list of (i) all Medicaid, Tricare and other state and federal government health care program participation agreements, or, in the case of Medicare, each provider number, and (ii) the top twenty-five (25) payors, by revenue, in each case, of the Borrower and its Subsidiaries, on a consolidated basis, as of the Closing Date.
(d) None of the Borrower, any of its Subsidiaries, or their respective officers, directors and, to the Borrowers knowledge, employees, agents and contractors has been or is currently excluded from participation in government health care programs pursuant to 42 U.S.C. § 1320a-7; except (i) as set forth on Schedule 5.26(d) and (ii) with respect to employees, agents or contractors, where exclusion from participation in such government health programs could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(eb) Except Borrower will, 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 all applicable Services, except to the extent such failure to keep in full force and effect or maintain would not reasonably be expected to have a Material Adverse Effect.
(ii) Promptly furnish or cause to be furnished to the Agent, with respect to matters that could reasonably be expected to have a Material Adverse Effect, (w) 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, (x) 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, (y) copies of all material warnings and material untitled letters as set forth on Schedule 5.26(e)well as other material documents received by Loan Parties or any of their Subsidiaries from the FDA, as CMS, DEA, or any other Governmental Authority relating to or arising out of the Closing Date, none conduct applicable to the business of the Borrower 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 (z) 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 hospice that is not a Subsidiary but is operated by Borrower agent thereof) of fraudulent activities of any Loan Party or a Subsidiary (i) is a party any of its Subsidiaries in relation to a corporate integrity agreementthe provision of clinical research or related services. Notwithstanding anything to the contrary in any Loan Document, (ii) has no Loan Party or any reporting obligations pursuant of its Subsidiaries shall be required to a settlement agreement, plan of correction, furnish to Agent or any Lender patient-related or other remedial measure entered into with information, the disclosure of which to Agent or such Lender is prohibited by any Governmental Authority, or (iii) has been served with or received any search warrant, subpoena, civil investigative demand or contact letter, or received notice of any audit (other than routine audits in the ordinary course of business) from any Governmental Agency related to its business operations. The Borrower and each of its Subsidiaries, as applicable, has complied in all material respects with the terms and conditions of any corporate integrity agreements, settlement agreements, plans of correction, other remedial measures, search warrants, subpoenas, civil investigative demands, or contract letters set forth on Schedule 5.26(e)applicable law.
Appears in 1 contract
Samples: Credit Agreement (Hooper Holmes Inc)
Compliance with Health Care Laws. Without limiting the generality of any other representation and warranty contained herein:
(a) Except as could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, each of Borrower, its Subsidiaries, and their respective officers, directors, employees, agents and contractors (exercising their respective duties on behalf Each of the Borrower or any of Company and its Subsidiaries) and each hospice that is not a Subsidiary operated by Borrower or a Subsidiary Subsidiaries is, and within the last six years at all times since December 31, 2019, has been, in compliance with all relevant Health Care applicable Healthcare Laws, and, with respect except for any failure to the civil monetary penalty law (42 U.S.C. § 1320a-7a), none of them has engaged in any conduct so comply that would result in a material violation of any law or regulation for which penalties could be imposed under 42 U.S.C. § 1320a-7a.
(b) Except as set forth on Schedule 5.26(b) and except as could not, individually or in the aggregate reasonably be expected to not have a Material Adverse Effect, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary has (i) all licenses, consents, certificates, permits, authorizations, approvals, franchises, registrations, certificates of need, accreditations, and other rights from, and has made all declarations and filings with, all applicable Governmental Authorities and accrediting organizations (each, a “Health Care Permit”) necessary to operate its business, and (ii) not received notice and has no knowledge that any Governmental Authority or accreditation organization is considering limiting, suspending, terminating, or revoking any such Health Care Permit. All such Health Care Permits are valid and in full force and effect, except as could not reasonably be expected to have a Material Adverse Effect, and the Borrower and each of its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary is in material compliance with the terms and conditions of all such Health Care Permits and with the rules and regulations of the Governmental Authorities and accrediting organizations having jurisdiction with respect to such Health Care Permits.
(c) To the extent it participates in a particular Program, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary meets all of the requirements of participation and payment of Medicare, Medicaid, Tricare any other state or federal government health care programs, and any other public or private third party payor programs (collectively, “Programs”) and is a party to valid participation agreements for payment by such Programs, except as could not reasonably be expected to have a Material Adverse Effect. Except as set forth on Schedule 5.26(c), there is no investigation, audit, claim review, or other action pending or, to the knowledge of the Borrower, threatened which could result in a revocation, suspension, termination, probation, material restriction, material limitation, or non-renewal of any Program participation agreement or result in the Borrowers or any of its Subsidiaries exclusion from any Program, except as could not reasonably be expected to have a Material Adverse Effect. Schedule 5.26(c) sets forth an accurate, complete and current list of (i) all Medicaid, Tricare and other state and federal government health care program participation agreements, or, in the case of Medicare, each provider number, and (ii) the top twenty-five (25) payors, by revenue, in each case, of the Borrower and its Subsidiaries, on a consolidated basis, as of the Closing Date.
(d) None of the Borrower, any of its Subsidiaries, or their respective officers, directors and, to the Borrowers knowledge, employees, agents and contractors has been or is currently excluded from participation in government health care programs pursuant to 42 U.S.C. § 1320a-7; except (i) as set forth on Schedule 5.26(d) and (ii) with respect to employees, agents or contractors, where exclusion from participation in such government health programs could not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect.
(eb) Since December 31, 2019, neither the Company nor any of its Subsidiaries has received any written notice or communication from any Person commencing or threatening any Action alleging any noncompliance by, or liability of, the Company or its Subsidiaries under any Healthcare Law that would be material to the Company and its Subsidiaries, taken as a whole. There are no Actions pending, or to the Knowledge of the Company, threatened against the Company or its Subsidiaries alleging any violation of any applicable Healthcare Law, except for any failure to so comply that would not have a Company Material Adverse Effect. None of the Company, the Subsidiaries, or their respective directors, executive officers, managers, managing employees (as such term is defined in 42 U.S.C. § 1320a-5(b)), or, to the Knowledge of the Company, employees, agents, vendors, or independent contractors is or has been since December 1, 2019; (i) debarred, suspended, or excluded from participation in any “Federal Health Care Program,” as defined at 42 USC §1320a-7b(f); (ii) subject to a civil monetary penalty assessed under Section 1128A of the Social Security Act, sanctioned, indicted or convicted of a crime, or pled nolo contendere or to sufficient facts, in connection with any allegation of violation of any Governmental Health Program Law; (iii) listed on the General Services Administration’s published list of parties excluded from federal procurement programs and non-procurement programs; (iv) designated a Specially Designated National or Blocked Person by the Office of Foreign Assets Control of the U.S. Department of Treasury; or (v) subject to any other Governmental Entity debarment, exclusion or sanction list or database.
(c) Except as set forth on Schedule 5.26(e)would not have a Company Material Adverse Effect, since December 31, 2019, each of the Company and its Subsidiaries has at all times been in compliance with HIPAA, and has implemented written policies and procedures, as of well as other administrative, physical and technical safeguards, that comply with HIPAA. Neither the Closing DateCompany nor its Subsidiaries has received any notice of, none of and there is no Action pending or threatened with respect to, any alleged “breach” by the Borrower Company or any of its Subsidiaries or their “workforce.” Since December 31, 2019, no “breach” by the Company, its Subsidiaries, or any hospice that is not a Subsidiary but is operated their “workforce,” or successful “security incident,” has occurred with respect to Protected Health Information (as defined by Borrower or a Subsidiary (iHIPAA) is a party to a corporate integrity agreement, (ii) has any reporting obligations pursuant to a settlement agreement, plan of correction, or other remedial measure entered into with any Governmental Authority, or (iii) has been served with or received any search warrant, subpoena, civil investigative demand or contact letter, or received notice of any audit (other than routine audits in the ordinary course possession or under the control of business) from any Governmental Agency related to its business operations. The Borrower and each of the Company or its Subsidiaries, as applicabletheir “workforce” or, to the Knowledge of the Company, their “business associates,” with respect to Protected Health Information held by such business associates on behalf of the Company or its Subsidiaries, that requires notification to the United States Secretary of Health and Human Services under 45 C.F.R. § 164.408(b). Each of the Company and its Subsidiaries has undertaken an enterprise-wide security risk analysis, has complied in implemented risk management activities required by HIPAA, and has implemented appropriate corrective action to address all material respects with vulnerabilities identified through such risk analyses, except as would not have a Company Material Adverse Effect. Each of the terms Company and conditions of any corporate integrity its Subsidiaries has written, signed, and HIPAA-compliant business associate agreements, settlement agreementswhen required. All quoted terms in this section shall have the meaning ascribed to them in HIPAA.
(d) Each of the Company, plans and its Subsidiaries maintains a compliance program having the elements of correctionan effective corporate compliance and ethics program. Except as would not have a Company Material Adverse Effect, other remedial measuresthere are no material outstanding compliance complaints or reports, search warrants, subpoenas, civil investigative demandsongoing internal compliance investigations, or contract letters set forth on Schedule 5.26(e)outstanding compliance corrective actions.
Appears in 1 contract
Compliance with Health Care Laws. Without limiting the generality of any other representation and warranty contained herein:
(a) Except as could notCredit Party and each of their respective Subsidiaries is in compliance with the Health Care Laws applicable to its business, individually or except where failure to be in the aggregate, such compliance would not reasonably be expected to have individually or in the aggregate a Material Adverse Effect, each of Borrower, its Subsidiaries, and their respective officers, directors, employees, agents and contractors (exercising their respective duties on behalf of the Borrower or any of its Subsidiaries) and each hospice that is not a Subsidiary operated by Borrower or a Subsidiary is, and within the last six years has been, in compliance with all relevant Health Care Laws, and, with respect to the civil monetary penalty law (42 U.S.C. § 1320a-7a), none of them has engaged in any conduct that would result in a material violation of any law or regulation for which penalties could be imposed under 42 U.S.C. § 1320a-7a.
(b) Except as set forth on Schedule 5.26(b) Each Credit Party and except as could not, individually or in the aggregate reasonably be expected to have a Material Adverse Effect, each of the Borrower and its their respective Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary has (i) all licenses, consents, certificates, permits, authorizations, approvals, franchises, registrations, certificates of need, accreditations, qualifications and other rights from, and has made all declarations and filings with, all applicable Governmental Authorities Authorities, all self-regulatory authorities and accrediting organizations all courts and other tribunals necessary to engage in the business conducted by it, 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 (each, a an “Health Care PermitAuthorization”) necessary to operate its business), and (ii) not received notice and has no actual knowledge that any Governmental Authority or accreditation organization is considering limiting, suspending, terminating, suspending or revoking any such Health Care PermitAuthorization. All such Health Care Permits Authorizations are valid and in full force and effect, except as could not reasonably be expected to have a Material Adverse Effect, effect and the Borrower each Credit Party and each of its their respective Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary is in material compliance with the terms and conditions of all such Health Care Permits Authorizations and with the rules and regulations of the Governmental Authorities and accrediting organizations regulatory authorities having jurisdiction with respect to such Health Care Permits.
(c) To the extent it participates in a particular Program, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary meets all of the requirements of participation and payment of Medicare, Medicaid, Tricare any other state or federal government health care programs, and any other public or private third party payor programs (collectively, “Programs”) and is a party to valid participation agreements for payment by such ProgramsAuthorizations, except as could where failure to be in such compliance or for an Authorization to be valid and in full force and effect would not reasonably be expected to have individually or in the aggregate a Material Adverse Effect. Except as set forth on Schedule 5.26(c).
(c) No Credit Party or any of their respective Subsidiaries or any of their respective officers, there is no investigation, audit, claim review, or other action pending directors 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 BorrowerU.S. government or its agencies pursuant to the Federal Acquisition Regulation, threatened which could result in a revocation, suspension, termination, probation, material restriction, material limitationrelating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or non-renewal other applicable laws or regulations; or (iii) made a party to any other action by any Governmental Authority that 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 any Program participation agreement or result in the Borrowers a Credit Party, or any of its their respective Subsidiaries exclusion from 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 Programother applicable requirement of law, except as could where failure to be in such compliance would not reasonably be expected to have a Material Adverse Effect. Schedule 5.26(c) sets forth an accurate, complete and current list of (i) all Medicaid, Tricare and other state and federal government health care program participation agreements, or, in the case of Medicare, each provider number, and (ii) the top twenty-five (25) payors, by revenue, in each case, of the Borrower and its Subsidiaries, on a consolidated basis, as of the Closing Date.
(d) None of the Borrower, any of its Subsidiaries, or their respective officers, directors and, to the Borrowers knowledge, employees, agents and contractors has been or is currently excluded from participation in government health care programs pursuant to 42 U.S.C. § 1320a-7; except (i) as set forth on Schedule 5.26(d) and (ii) with respect to employees, agents or contractors, where exclusion from participation in such government health programs could not, individually or in the aggregate, reasonably be expected to have aggregate a Material Adverse Effect.
(e) Except as set forth on Schedule 5.26(e), as of the Closing Date, none of the Borrower No Credit Party or any of its Subsidiariestheir respective Subsidiaries has received any written, or to 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 Borrower, any other Credit Party, or any hospice that is not a Subsidiary but is operated by Borrower of their respective Subsidiaries regarding any violation of applicable law, including any Health Care US-DOCS\99983253.20 Law. No Credit Party or a Subsidiary (i) any of their respective Subsidiaries is a party to a or has any obligation under any corporate integrity agreement, (ii) has any reporting obligations pursuant to a settlement monitoring agreement, plan of correctionconsent decree, settlement agreement or other remedial measure entered into with similar agreement related to any Health Care Law imposed by any Governmental Authority, or (iii) has been served with or received any search warrant, subpoena, civil investigative demand or contact letter, or received notice of any audit (other than routine audits in the ordinary course of business) from any Governmental Agency related to its business operations. The Borrower and each of its Subsidiaries, as applicable, has complied in all material respects with the terms and conditions of any corporate integrity agreements, settlement agreements, plans of correction, other remedial measures, search warrants, subpoenas, civil investigative demands, or contract letters set forth on Schedule 5.26(e).
Appears in 1 contract
Samples: Credit Agreement (R1 RCM Inc.)
Compliance with Health Care Laws. Without limiting the generality of any other representation and warranty contained herein:
(a) Except as could notWithout limiting or qualifying any provision of this Agreement, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, each of Borrower, its SubsidiariesCompany will comply, and their respective officers, directors, employees, agents and contractors (exercising their respective duties on behalf of the Borrower or any of its Subsidiaries) and each hospice that is not a Subsidiary operated by Borrower or a Subsidiary is, and within the last six years has been, in compliance with all relevant Health Care Laws, and, with respect to the civil monetary penalty law (42 U.S.C. § 1320a-7a), none of them has engaged in any conduct that would result in a material violation of any law or regulation for which penalties could be imposed under 42 U.S.C. § 1320a-7a.
(b) Except as set forth on Schedule 5.26(b) and except as could not, individually or in the aggregate reasonably be expected to have a Material Adverse Effect, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary has (i) all licenses, consents, certificates, permits, authorizations, approvals, franchises, registrations, certificates of need, accreditations, and other rights from, and has made all declarations and filings with, all applicable Governmental Authorities and accrediting organizations (each, a “Health Care Permit”) necessary to operate its business, and (ii) not received notice and has no knowledge that any Governmental Authority or accreditation organization is considering limiting, suspending, terminating, or revoking any such Health Care Permit. All such Health Care Permits are valid and in full force and effect, except as could not reasonably be expected to have a Material Adverse Effect, and the Borrower and will cause each of its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary is to comply, in all material compliance respects with the terms and conditions of all such applicable Health Care Permits and with Laws relating to the rules and regulations operation of the Governmental Authorities and accrediting organizations having jurisdiction with respect to such Health Care Permits.
(c) To the extent it participates in a particular Program, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary meets all of the requirements of participation and payment of Medicare, Medicaid, Tricare any other state or federal government health care programs, and any other public or private third party payor programs (collectively, “Programs”) and is a party to valid participation agreements for payment by such ProgramsFC2 Business, except as could where failure to comply would not reasonably be expected to have a Material Adverse Effect. Except as set forth on Schedule 5.26(c), there is no investigation, audit, claim review, or other action pending or, to the knowledge of the Borrower, threatened which could result in a revocation, suspension, termination, probation, material restriction, material limitation, or non-renewal of any Program participation agreement or result in the Borrowers or any of its Subsidiaries exclusion from any Program, except as could not reasonably be expected to have a Material Adverse Effect. Schedule 5.26(c) sets forth an accurate, complete and current list of (i) all Medicaid, Tricare and other state and federal government health care program participation agreements, or, in the case of Medicare, each provider number, and (ii) the top twenty-five (25) payors, by revenue, in each case, of the Borrower and its Subsidiaries, on a consolidated basis, as of the Closing Date.
(d) None of the Borrower, any of its Subsidiaries, or their respective officers, directors and, to the Borrowers knowledge, employees, agents and contractors has been or is currently excluded from participation in government health care programs pursuant to 42 U.S.C. § 1320a-7; except (i) as set forth on Schedule 5.26(d) and (ii) with respect to employees, agents or contractors, where exclusion from participation in such government health programs could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(eb) Except as set forth on Schedule 5.26(e)The Company will, as and will cause each of its Subsidiaries to:
(i) Keep in full force and effect all Authorizations required to operate the Closing DateFC2 Business under applicable Health Care Laws and maintain any other qualifications necessary to conduct, none arrange for, administer, provide services in connection with or receive payment for all applicable Services, except to the extent such failure to keep in full force and effect or maintain would not reasonably be expected to have a Material Adverse Effect.
(ii) Promptly furnish or cause to be furnished to SWK, with respect to matters that could reasonably be expected to have a Material Adverse Effect, (w) copies of all material reports of investigational/inspectional observations issued to and received by the Borrower Company or any of its Subsidiaries, and issued by any Governmental Authority relating to the FC2 Business, (x) copies of all material establishment investigation/inspection reports (including, but not limited to, FDA Form 483’s) issued to and received by the Company or any hospice of its Subsidiaries and issued by any Governmental Authority relative to the FC2 Product, (y) copies of all material warnings and material untitled letters as well as other material documents received by the Company or any of its Subsidiaries from the FDA, CMS, DEA, or any other Governmental Authority relating to or arising out of the conduct applicable to the FC2 Business of the Company or any of its Subsidiaries that is not 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 (z) 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 SWK, with respect to matters that would reasonably be expected to have a Subsidiary but is operated by Borrower or a Subsidiary (i) is a party Material Adverse Effect, copies of all non-privileged, reports, correspondence, pleadings and other communications relating to a corporate integrity agreement, any matter referred to in clause (ii) has above that could lead to the loss, revocation or suspension (or threatened loss, revocation or suspension) of any reporting obligations pursuant material Authorization or of any material qualification of the Company or any Subsidiary relating to the FC2 Business; provided that any internal reports to a settlement agreementPerson’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 SWK notice of all material fines or penalties imposed by any Governmental Authority under any Health Care Law against the Company or any of its Subsidiaries relative to the FC2 Business.
(v) Promptly furnish or cause to be furnished to SWK notice of all material allegations by any Governmental Authority (or any agent thereof) of fraudulent activities of the Company or any of its Subsidiaries in relation to the provision of clinical research or related services relative to the FC2 Business. Notwithstanding anything to the contrary in this Agreement, plan the Company or any of correction, its Subsidiaries shall not be required to furnish to SWK patient-related or other remedial measure entered into with information, the disclosure of which to SWK is prohibited by any Governmental Authority, or (iii) has been served with or received any search warrant, subpoena, civil investigative demand or contact letter, or received notice of any audit (other than routine audits in the ordinary course of business) from any Governmental Agency related to its business operations. The Borrower and each of its Subsidiaries, as applicable, has complied in all material respects with the terms and conditions of any corporate integrity agreements, settlement agreements, plans of correction, other remedial measures, search warrants, subpoenas, civil investigative demands, or contract letters set forth on Schedule 5.26(e)applicable law.
Appears in 1 contract
Compliance with Health Care Laws. Without limiting the generality of Section 4.13 or ---------------------------------- any other representation or warranty made herein, no Facility and, to Borrowers' best knowledge, no licensed employee or licensed contractor of any Borrower in the exercise of his or her respective duties on behalf of any Facility, has received written notice from any governmental authority regarding any currently existing violation of any, applicable statutes, laws, ordinances, rules and warranty contained herein:
regulations of any governmental authority with respect to regulatory matters primarily relating to patient healthcare (aincluding without limitation Section 1128B(b) Except of the Social Security Act, as amended, 42 U.S.C. Section 1320a-7(b) (Criminal Penalties Involving Medicare or State Health Care Programs), commonly referred to as the "Federal Anti-Kickback Statute," and the Social Security Act, as amended, Section 1877, 42 U.S.C. Section 1395nn (Prohibition Against Certain Referrals), commonly referred to as "Stark Statute" (collectively, "Healthcare Xxxs")), except as disclosed on Schedule 4.27 or as could not, individually or in the aggregate, not ------------- reasonably be expected to have a Material Adverse Effect. Borrowers maintain in all material respects all records required to be maintained by the Food and Drug Administration, each Drug Enforcement Agency and State Boards of Borrower, its Subsidiaries, and their respective officers, directors, employees, agents and contractors (exercising their respective duties on behalf of the Borrower or any of its Subsidiaries) and each hospice that is not a Subsidiary operated by Borrower or a Subsidiary is, and within the last six years has been, in compliance with all relevant Health Care Laws, Pharmacy and, with respect to the civil monetary penalty law (42 U.S.C. § 1320a-7a)extent such Borrowers participate in Medicare, none Medicaid and/or TRICARE, the federal and state Medicare, Medicaid and TRICARE programs as required by the Healthcare Laws and to the knowledge of them has engaged Borrowers, Borrowers are not in any conduct that would result in a material violation of any law or regulation for Healthcare Laws which penalties violation could be imposed under 42 U.S.C. § 1320a-7a.
(b) Except as set forth on Schedule 5.26(b) and except as could not, individually or in the aggregate reasonably be expected to have a Material Adverse Effect. Borrowers have such permits, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary has (i) all licenses, consentsfranchises, certificates and other approvals or authorizations of governmental or regulatory authorities as are necessary under applicable law to own their respective properties and to conduct their respective businesses, and with respect to those Facilities that participate in Medicare, Medicaid and/or TRICARE, to receive reimbursement under such programs, other than such permits, licenses, franchises, certificates, permitsapprovals and authorizations the lack of which, authorizationsindividually or in the aggregate, approvals, franchises, registrations, certificates of need, accreditations, and other rights from, and has made all declarations and filings with, all applicable Governmental Authorities and accrediting organizations (each, a “Health Care Permit”) necessary to operate its business, and (ii) not received notice and has no knowledge that any Governmental Authority or accreditation organization is considering limiting, suspending, terminating, or revoking any such Health Care Permit. All such Health Care Permits are valid and in full force and effect, except as could not reasonably be expected to have a Material Adverse Effect, and the Borrower and each of its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary is in material compliance with the terms and conditions of all such Health Care Permits and with the rules and regulations of the Governmental Authorities and accrediting organizations having jurisdiction with respect to such Health Care Permits.
(c) To the extent it participates in a particular Program, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary meets all of the requirements of participation and payment of Medicare, Medicaid, Tricare any other state or federal government health care programs, and any other public or private third party payor programs (collectively, “Programs”) and is a party to valid participation agreements for payment by such Programs, except as could not reasonably be expected to have a Material Adverse Effect. Except as set forth on Schedule 5.26(c)To Borrowers' best knowledge, there is are no investigation, audit, claim review, or other action pending or, to existing sanctions in the knowledge form of the Borrower, threatened which could result in either a revocation, suspension, program termination, probationtemporary management, material restrictiondenial of payment for new admissions, material limitation, state monitoring or non-renewal facility closure imposed by the Center of Medicare and Medicaid Services ("CMS") or the applicable state survey agency on any Program participation agreement or result in the Borrowers or any of its Subsidiaries exclusion from any ProgramFacility, except as disclosed on Schedule 4.27 that could not reasonably be expected to have a Material Adverse Effect. Schedule 5.26(c) sets forth an accurate, complete and current list of (i) all Medicaid, Tricare and other state and federal government health care program participation agreements, or, in the case of Medicare, each provider number, and (ii) the top twenty-five (25) payors, by revenue, in each case, of the Borrower and its Subsidiaries, on a consolidated basis, as of the Closing Date.
(d) None of the Borrower, any of its Subsidiaries, or their respective officers, directors and, to the Borrowers knowledge, employees, agents and contractors has been or is currently excluded from participation in government health care programs pursuant to 42 U.S.C. § 1320a-7; except (i) as set forth on Schedule 5.26(d) and (ii) with respect to employees, agents or contractors, where exclusion from participation in such government health programs could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(e) Except as set forth on Schedule 5.26(e), as of the Closing Date, none of the Borrower or any of its Subsidiaries, or any hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary (i) is a party to a corporate integrity agreement, (ii) has any reporting obligations pursuant to a settlement agreement, plan of correction, or other remedial measure entered into with any Governmental Authority, or (iii) has been served with or received any search warrant, subpoena, civil investigative demand or contact letter, or received notice of any audit (other than routine audits in the ordinary course of business) from any Governmental Agency related to its business operations. The Borrower and each of its Subsidiaries, as applicable, has complied in all material respects with the terms and conditions of any corporate integrity agreements, settlement agreements, plans of correction, other remedial measures, search warrants, subpoenas, civil investigative demands, or contract letters set forth on Schedule 5.26(e).-------------
Appears in 1 contract
Samples: Loan and Security Agreement (Harborside Healthcare Corp)
Compliance with Health Care Laws. Without limiting the generality of any other representation and warranty contained herein:
(a) Except as could notHoldco and each of its Subsidiaries has made all requisite filings with the FDA and is in compliance in all material respects with all Laws applicable to them in respect of the manufacture, individually or packaging, marketing, storing, testing, and distributing of the Products including, but not limited to, those relating to the adulteration, mislabeling and misbranding of the Products and current good manufacturing practices in the aggregate, reasonably be expected to have a Material Adverse Effect, each United States of Borrower, its Subsidiaries, and their respective officers, directors, employees, agents and contractors America (exercising their respective duties on behalf of the Borrower or any of its Subsidiaries) and each hospice that is not a Subsidiary operated by Borrower or a Subsidiary is, and within the last six years has been, in compliance with all relevant Health Care Laws, and, with respect to the civil monetary penalty law (42 U.S.C. § 1320a-7a“cGMPs”), none of them has engaged in any conduct that would result in a material violation of any law or regulation for which penalties could be imposed under 42 U.S.C. § 1320a-7a.
(b) Since October 31, 2009, Holdco and its Subsidiaries have filed all serious adverse event reports required to be made to the FDA and other Governmental Authorities under applicable Laws relating to the Products.
(c) Except as set forth on Schedule 5.26(b) and except as could not7.13(c), individually no Product or in the aggregate reasonably be expected to have a Material Adverse Effectproduct candidate currently being manufactured, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated developed, tested, distributed or marketed by Borrower either Holdco or a Subsidiary has (i) all licenses, consents, certificates, permits, authorizations, approvals, franchises, registrations, certificates of need, accreditations, and other rights from, and has made all declarations and filings with, all applicable Governmental Authorities and accrediting organizations (each, a “Health Care Permit”) necessary to operate its business, and (ii) not received notice and has no knowledge that any Governmental Authority or accreditation organization is considering limiting, suspending, terminating, or revoking any such Health Care Permit. All such Health Care Permits are valid and in full force and effect, except as could not reasonably be expected to have a Material Adverse Effect, and the Borrower and each of its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower has been recalled or a Subsidiary is in material compliance with the terms and conditions of all such Health Care Permits and with the rules and regulations of the Governmental Authorities and accrediting organizations having jurisdiction with respect to such Health Care Permits.
withdrawn from market (c) To the extent it participates in a particular Program, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower whether voluntarily or a Subsidiary meets all of the requirements of participation and payment of Medicare, Medicaid, Tricare any other state or federal government health care programs, and any other public or private third party payor programs (collectively, “Programs”) and is a party to valid participation agreements for payment by such Programs, except as could not reasonably be expected to have a Material Adverse Effectotherwise). Except as set forth on Schedule 5.26(c7.13(c), there is no investigationproceedings (whether completed or pending) seeking the recall, auditwithdrawal, claim reviewsuspension or seizure of any such Product or product candidate or pre-market approvals or marketing authorizations are pending, or other action pending or, to the knowledge of the BorrowerHoldco, threatened which could result in a revocationthreatened, suspension, termination, probation, material restriction, material limitation, or non-renewal of any Program participation agreement or result in the Borrowers or any of its Subsidiaries exclusion from any Program, except as could not reasonably be expected to have a Material Adverse Effect. Schedule 5.26(c) sets forth an accurate, complete and current list of (i) all Medicaid, Tricare and other state and federal government health care program participation agreements, or, in the case of Medicare, each provider number, and (ii) the top twenty-five (25) payors, by revenue, in each case, of the Borrower and its Subsidiaries, on a consolidated basis, as of the Closing Date.
(d) None of the Borrower, any of its Subsidiaries, or their respective officers, directors and, to the Borrowers knowledge, employees, agents and contractors has been or is currently excluded from participation in government health care programs pursuant to 42 U.S.C. § 1320a-7; except (i) as set forth on Schedule 5.26(d) and (ii) with respect to employees, agents or contractors, where exclusion from participation in such government health programs could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(e) Except as set forth on Schedule 5.26(e), as of the Closing Date, none of the Borrower against Holdco or any of its Subsidiaries, nor have any such proceedings been pending at any time. Neither Holdco nor any of its Subsidiaries is considering any recall or any hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary (i) is a party to a corporate integrity agreement, (ii) has any reporting obligations pursuant to a settlement agreement, plan warning in respect of correction, or other remedial measure entered into with any Governmental Authority, or (iii) has been served with or received any search warrant, subpoena, civil investigative demand or contact letter, or received notice the Products. To the knowledge of any audit (other than routine audits in the ordinary course of business) from any Governmental Agency related to its business operations. The Borrower Holdco and each of its Subsidiaries, as applicableno Governmental Authority has threatened to implement any recall with respect to the Products.
(d) To the knowledge of Holdco, has complied each Material Supplier (A) is in compliance in all material respects with all Laws applicable to the terms manufacture, packaging, storing, testing, and conditions distributing of any corporate integrity agreementsthe Products including, settlement agreementsbut not limited to, plans those relating to cGMPs and FDA’s quality system regulations (“QSRs”), applicable to the functions performed by it for Holdco or its Subsidiaries in respect of correctionthe Products, other remedial measuresand (B) possesses, search warrantsand is in compliance with, subpoenasall material Governmental Approvals necessary for the manufacture, civil investigative demandspackaging, storing, testing, and distributing of the Products including, but not limited to, facility establishment registrations, applicable to the functions performed by it for Holdco or contract letters set forth on Schedule 5.26(e)its Subsidiaries in respect of such Products.
Appears in 1 contract
Samples: Stock Purchase Agreement (Prestige Brands Holdings, Inc.)
Compliance with Health Care Laws. Without limiting the generality of any other representation and warranty contained herein:
(a) Except as could notWithout limiting or qualifying Section 6.4 or any other provision of this Agreement, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, each of Borrower, its SubsidiariesBorrower will comply, and their respective officers, directors, employees, agents and contractors (exercising their respective duties on behalf of the Borrower or any of its Subsidiaries) will cause each other Loan Party and each hospice that is not a Subsidiary operated by of Borrower or a Subsidiary is, and within the last six years has beento comply, in compliance all material respects with all relevant applicable Health Care Laws, and, with respect Laws relating to the civil monetary penalty law (42 U.S.C. § 1320a-7a), none operation of them has engaged in any conduct that would result in a material violation of any law or regulation for which penalties could be imposed under 42 U.S.C. § 1320a-7a.
(b) Except as set forth on Schedule 5.26(b) and except as could not, individually or in the aggregate reasonably be expected to have a Material Adverse Effect, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary has (i) all licenses, consents, certificates, permits, authorizations, approvals, franchises, registrations, certificates of need, accreditations, and other rights from, and has made all declarations and filings with, all applicable Governmental Authorities and accrediting organizations (each, a “Health Care Permit”) necessary to operate its such Person’s business, and (ii) except where failure to comply would not received notice and has no knowledge that any Governmental Authority or accreditation organization is considering limiting, suspending, terminating, or revoking any such Health Care Permit. All such Health Care Permits are valid and in full force and effect, except as could not reasonably be expected to have a Material Adverse Effect, and the Borrower and each of its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary is in material compliance with the terms and conditions of all such Health Care Permits and with the rules and regulations of the Governmental Authorities and accrediting organizations having jurisdiction with respect to such Health Care Permits.
(c) To the extent it participates in a particular Program, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary meets all of the requirements of participation and payment of Medicare, Medicaid, Tricare any other state or federal government health care programs, and any other public or private third party payor programs (collectively, “Programs”) and is a party to valid participation agreements for payment by such Programs, except as could not reasonably be expected to have a Material Adverse Effect. Except as set forth on Schedule 5.26(c), there is no investigation, audit, claim review, or other action pending or, to the knowledge of the Borrower, threatened which could result in a revocation, suspension, termination, probation, material restriction, material limitation, or non-renewal of any Program participation agreement or result in the Borrowers or any of its Subsidiaries exclusion from any Program, except as could not reasonably be expected to have a Material Adverse Effect. Schedule 5.26(c) sets forth an accurate, complete and current list of (i) all Medicaid, Tricare and other state and federal government health care program participation agreements, or, in the case of Medicare, each provider number, and (ii) the top twenty-five (25) payors, by revenue, in each case, of the Borrower and its Subsidiaries, on a consolidated basis, as of the Closing Date.
(d) None of the Borrower, any of its Subsidiaries, or their respective officers, directors and, to the Borrowers knowledge, employees, agents and contractors has been or is currently excluded from participation in government health care programs pursuant to 42 U.S.C. § 1320a-7; except (i) as set forth on Schedule 5.26(d) and (ii) with respect to employees, agents or contractors, where exclusion from participation in such government health programs could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(eb) Except Borrower will, 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 all applicable Services, except to the extent such failure to keep in full force and effect or maintain would not reasonably be expected to have a Material Adverse Effect.
(ii) Promptly furnish or cause to be furnished to the Agent, with respect to matters that could reasonably be expected to have a Material Adverse Effect, (w) copies of all material written 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, (x) copies of all material written 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, (y) copies of all material written warnings and material untitled letters as set forth on Schedule 5.26(e)well as other material documents received by Loan Parties or any of their Subsidiaries from the FDA, as CMS or any other Governmental Authority relating to or arising out of the Closing Date, none conduct of the Borrower Loan Parties or any of their Subsidiaries 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 (z) written notice of any material investigation or material audit or similar proceeding by the FDA, 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 written 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 - 45 - [Biolase] Credit Agreement #61304369 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 written allegations by any Governmental Authority (or any hospice that is not a Subsidiary but is operated by Borrower agent thereof) of fraudulent activities of any Loan Party or a Subsidiary (i) is a party any of its Subsidiaries in relation to a corporate integrity agreementthe provision of clinical research or related services. Notwithstanding anything to the contrary in any Loan Document, (ii) has no Loan Party or any reporting obligations pursuant of its Subsidiaries shall be required to a settlement agreement, plan of correction, furnish to Agent or any Lender patient- related or other remedial measure entered into with information, the disclosure of which to Agent or such Lender is prohibited by any Governmental Authority, or (iii) has been served with or received any search warrant, subpoena, civil investigative demand or contact letter, or received notice of any audit (other than routine audits in the ordinary course of business) from any Governmental Agency related to its business operations. The Borrower and each of its Subsidiaries, as applicable, has complied in all material respects with the terms and conditions of any corporate integrity agreements, settlement agreements, plans of correction, other remedial measures, search warrants, subpoenas, civil investigative demands, or contract letters set forth on Schedule 5.26(e)applicable law.
Appears in 1 contract
Samples: Credit Agreement (Biolase, Inc)
Compliance with Health Care Laws. Without limiting the generality of any other representation and warranty contained herein:
(a) Except as could notWithout limiting or qualifying Section 6.4 or any other provision of this Agreement, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, each of Borrower, its SubsidiariesBorrower will comply, and their respective officers, directors, employees, agents and contractors (exercising their respective duties on behalf of the Borrower or any of its Subsidiaries) will cause each other Loan Party and each hospice that is not a Subsidiary operated by of Borrower or a Subsidiary is, and within the last six years has beento comply, in compliance all material respects with all relevant applicable Health Care Laws, and, with respect Laws relating to the civil monetary penalty law (42 U.S.C. § 1320a-7a), none operation of them has engaged in any conduct that would result in a material violation of any law or regulation for which penalties could be imposed under 42 U.S.C. § 1320a-7a.
(b) Except as set forth on Schedule 5.26(b) and except as could not, individually or in the aggregate reasonably be expected to have a Material Adverse Effect, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary has (i) all licenses, consents, certificates, permits, authorizations, approvals, franchises, registrations, certificates of need, accreditations, and other rights from, and has made all declarations and filings with, all applicable Governmental Authorities and accrediting organizations (each, a “Health Care Permit”) necessary to operate its such Person’s business, and (ii) except where failure to comply would not received notice and has no knowledge that any Governmental Authority or accreditation organization is considering limiting, suspending, terminating, or revoking any such Health Care Permit. All such Health Care Permits are valid and in full force and effect, except as could not reasonably be expected to have a Material Adverse Effect, and the Borrower and each of its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary is in material compliance with the terms and conditions of all such Health Care Permits and with the rules and regulations of the Governmental Authorities and accrediting organizations having jurisdiction with respect to such Health Care Permits.
(c) To the extent it participates in a particular Program, each of the Borrower and its Subsidiaries and each hospice that is not a Subsidiary but is operated by Borrower or a Subsidiary meets all of the requirements of participation and payment of Medicare, Medicaid, Tricare any other state or federal government health care programs, and any other public or private third party payor programs (collectively, “Programs”) and is a party to valid participation agreements for payment by such Programs, except as could not reasonably be expected to have a Material Adverse Effect. Except as set forth on Schedule 5.26(c), there is no investigation, audit, claim review, or other action pending or, to the knowledge of the Borrower, threatened which could result in a revocation, suspension, termination, probation, material restriction, material limitation, or non-renewal of any Program participation agreement or result in the Borrowers or any of its Subsidiaries exclusion from any Program, except as could not reasonably be expected to have a Material Adverse Effect. Schedule 5.26(c) sets forth an accurate, complete and current list of (i) all Medicaid, Tricare and other state and federal government health care program participation agreements, or, in the case of Medicare, each provider number, and (ii) the top twenty-five (25) payors, by revenue, in each case, of the Borrower and its Subsidiaries, on a consolidated basis, as of the Closing Date.
(d) None of the Borrower, any of its Subsidiaries, or their respective officers, directors and, to the Borrowers knowledge, employees, agents and contractors has been or is currently excluded from participation in government health care programs pursuant to 42 U.S.C. § 1320a-7; except (i) as set forth on Schedule 5.26(d) and (ii) with respect to employees, agents or contractors, where exclusion from participation in such government health programs could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(eb) Except Borrower will, 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 all applicable Services, except to the extent such failure to keep in full force and effect or maintain would not reasonably be expected to have a Material Adverse Effect.
(ii) Promptly furnish or cause to be furnished to the Agent, with respect to matters that could reasonably be expected to have a Material Adverse Effect, (w) copies of all material written 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, (x) copies of all material written 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, (y) copies of all material written warnings and material untitled letters as set forth on Schedule 5.26(e)well as other material documents received by Loan Parties or any of their Subsidiaries from the FDA, as CMS or any other Governmental Authority relating to or arising out of the Closing Date, none conduct of the Borrower Loan Parties or any of their Subsidiaries 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 (z) written notice of any material investigation or material audit or similar proceeding by the FDA, 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 written 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 written allegations by any Governmental Authority (or any hospice that is not a Subsidiary but is operated by Borrower agent thereof) of fraudulent activities of any Loan Party or a Subsidiary (i) is a party any of its Subsidiaries in relation to a corporate integrity agreementthe provision of clinical research or related services. Notwithstanding anything to the contrary in any Loan Document, (ii) has no Loan Party or any reporting obligations pursuant of its Subsidiaries shall be required to a settlement agreement, plan of correction, furnish to Agent or any Lender patient-related or other remedial measure entered into with information, the disclosure of which to Agent or such Lender is prohibited by any Governmental Authority, or (iii) has been served with or received any search warrant, subpoena, civil investigative demand or contact letter, or received notice of any audit (other than routine audits in the ordinary course of business) from any Governmental Agency related to its business operations. The Borrower and each of its Subsidiaries, as applicable, has complied in all material respects with the terms and conditions of any corporate integrity agreements, settlement agreements, plans of correction, other remedial measures, search warrants, subpoenas, civil investigative demands, or contract letters set forth on Schedule 5.26(e)applicable law.
Appears in 1 contract
Samples: Credit Agreement (Biolase, Inc)