Common use of Healthcare Regulatory Laws Clause in Contracts

Healthcare Regulatory Laws. (a) None of Company and its Subsidiaries, nor any officer, director, managing employee or, to the knowledge of Company and its Subsidiaries, agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, is a party to, or bound by, any written order, corporate integrity agreement or other formal written agreement with any Governmental Authority concerning their compliance with Federal Health Care Program Laws. (b) None of Company and its Subsidiaries, nor any officer, director, managing employee or, to the knowledge of Company and its Subsidiaries, agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, nor to the knowledge of Company and its Subsidiaries, any Loan Party Partner: (i) is currently charged with or has been convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the SSA; (iii) has been listed on the U.S. General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; or (iv) to the knowledge of Company and its Subsidiaries, is the target or subject of any current investigation relating to any of the foregoing or any Federal Health Care Program-related offense. None of Company and its Subsidiaries, nor any officer, director, managing employee or, to the knowledge of Company and its Subsidiaries, any agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, nor to the knowledge of Company and its Subsidiaries, any Loan Party Partner, has been debarred, excluded, disqualified or suspended from participation in any Federal Health Care Program or under any FDA Laws, Federal Healthcare Program Laws or Public Health Laws (including 21 U.S.C. § 335a). (c) None of Company and its Subsidiaries, nor any officer, director, managing employee or, to the knowledge of Company and its Subsidiaries, any agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, nor to the knowledge of Company and its Subsidiaries, any Loan Party Partner, has engaged in any activity that is in material violation of any Federal Health Care Program Laws, including the following: (i) knowingly and willfully making or causing to be made a false statement or representation of a material fact in any application for any benefit or payment; (ii) knowingly and willfully making or causing to be made a false statement or representation of a material fact for use in determining rights to any benefit or payment; (iii) knowingly and willfully soliciting or receiving any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or kind (1) in return for referring an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under any Federal Health Care Program; or (2) in return for purchasing, leasing, or ordering, or arranging, or arranging for or recommending purchasing, leasing, or ordering any good, facility, service or item for which payment may be made in whole or in part under any Federal Health Care Program; or (iv) knowingly and willfully offering or paying any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to any person to induce such person (1) to refer an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal Health Care Program; or (2) to purchase, lease, order or arrange for or recommend purchasing, leasing or ordering any good, facility, service or item for which payment may be made in whole or in part under a Federal Health Care Program. (d) To the knowledge of Company and its Subsidiaries, no person has filed or has threatened to file against Company or any of its Subsidiaries, an action relating to any FDA Law, Public Health Law or Federal Health Care Program Law under any whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.) that would adversely affect the rights, remedies and benefits available to, or conferred upon, Administrative Agent and any Lender or any other Secured Party under any Loan Document in any material respect. (e) To the extent applicable, each of Company and its Subsidiaries is in compliance in all material respects with HIPAA, and the provisions of all business associate agreements (as such term is defined by HIPAA) to which it is a party, and has implemented reasonably adequate policies, procedures and training designed to assure continued compliance and to detect non-compliance, except where the failure to implement such policies, procedures, and training would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.

Healthcare Regulatory Laws. (ai) Each of Company and its Subsidiaries is operating, and since [***] has been operating in material compliance with applicable Health Care Program Laws. (ii) None of Company and its Subsidiaries, nor nor, to the Knowledge of Company, any officer, director, managing employee or, to the knowledge of Company and its Subsidiaries, or agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, is a party to, or bound by, any Regulatory Action, including without limitation, any written order, individual integrity agreement, corporate integrity agreement, deferred or non-prosecution agreement or other formal written agreement with any Governmental Authority concerning their compliance with Federal Health Care Program Laws. (biii) None of Company and its Subsidiaries, nor any officer, director, managing employee or, to the knowledge of Company and its Subsidiaries, or agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, nor to the knowledge Knowledge of Company and its SubsidiariesCompany, any Loan Party Company Partner: (iA) is currently has been, since [***], charged with or has been convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Programfederal health care program; (iiB) has had had, ​ ​ since [***], a civil monetary penalty assessed against it, him or her under Section 1128A of the SSASocial Security Act; (iiiC) has been listed on the U.S. General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; or (ivD) to the knowledge Knowledge of Company and its SubsidiariesCompany, is the target or subject of any current or potential suit, claim, action, proceeding, arbitration, mediation, inquiry, subpoena or investigation relating to any of the foregoing or any Federal Health Care Programfederal health care program-related offense, or which could result in the imposition of material penalties or the debarment, suspension or exclusion from participation in any federal health care program. None of Company and its Subsidiaries, nor any officer, director, managing employee oror agent [***] (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, to the knowledge nor any Company Partner, has been debarred, excluded, disqualified or suspended from participation in any federal health care program or under any FDA Laws (including 21 U.S.C. § 335a). (iv) None of Company and its Subsidiaries, nor any officer, director, managing employee or agent [***] (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, nor to the knowledge Knowledge of Company and its SubsidiariesCompany, any Loan Party Company Partner, has been debarredhas, excludedsince [***], disqualified violated or suspended from participation in any Federal Health Care Program or under any FDA Laws, Federal Healthcare Program Laws or Public Health Laws (including 21 U.S.C. § 335a). (c) None of Company and its Subsidiaries, nor any officer, director, managing employee or, to the knowledge of Company and its Subsidiaries, any agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, nor to the knowledge of Company and its Subsidiaries, any Loan Party Partner, has engaged in any activity that is in material violation of any Federal Health Care Program LawsLaws or cause for false claims liability, including the following: (i) knowingly and willfully making civil penalties or causing to be made a false statement mandatory or representation of a material fact in permissive exclusion from any application for any benefit or payment; (ii) knowingly and willfully making or causing to be made a false statement or representation of a material fact for use in determining rights to any benefit or payment; (iii) knowingly and willfully soliciting or receiving any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or kind (1) in return for referring an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under any Federal Health Care Program; or (2) in return for purchasing, leasing, or ordering, or arranging, or arranging for or recommending purchasing, leasing, or ordering any good, facility, service or item for which payment may be made in whole or in part under any Federal Health Care Program; or (iv) knowingly and willfully offering or paying any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to any person to induce such person (1) to refer an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal Health Care Program; or (2) to purchase, lease, order or arrange for or recommend purchasing, leasing or ordering any good, facility, service or item for which payment may be made in whole or in part under a Federal Health Care Programfederal health care program. (dv) To the knowledge Knowledge of Company and its SubsidiariesCompany, no person has filed or has threatened to file against Company or any of its Subsidiaries, an action relating to any FDA Law, Public Health Law or Federal Health Care Program Law under any whistleblower statute, including under without limitation, the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.) that would adversely affect the rights, remedies and benefits available to, or conferred upon, Administrative Agent and any Lender or any other Secured Party under any Loan Document in any material respect). (evi) To the extent applicable, each of Company and its Subsidiaries is in compliance in all material respects with HIPAA, and the provisions of all business associate agreements (as such term is defined by HIPAA) to which it is a party, and has implemented reasonably adequate policies, procedures and training designed to assure continued compliance and to detect non-compliance, except where the failure to implement such policies, procedures, and training would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect[***].

Healthcare Regulatory Laws. (a) None of the Company and its Subsidiaries, nor nor, to their knowledge, any officer, director, managing employee or, to the knowledge of Company and its Subsidiaries, or agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, is a party to, or bound by, any written order, individual integrity agreement, corporate integrity agreement, deferred or non-prosecution agreement or other formal written agreement with any Governmental Authority concerning their compliance with Federal Health Care Program Laws. . (b) None of the Company and its Subsidiaries, nor any officer, director, managing employee or, to the knowledge of Company and its Subsidiaries, or agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, nor to the knowledge of the Company and its Subsidiaries, any Loan Party Partner: (i) is currently has been, since July 1, 2017, charged with or has been convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program; (ii) has had had, since July 1, 2017, a civil monetary penalty assessed against it, him or her under Section 1128A of the SSASocial Security Act; (iii) has been listed on the U.S. General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; or (iv) to the knowledge of the Company and its Subsidiaries, is the target or subject of any current or potential suit, claim, action, proceeding, arbitration, mediation, inquiry, subpoena or investigation relating to any of the foregoing or any Federal Health Care Program-related offense, or which could result in the imposition of material penalties or the debarment, suspension or exclusion from participation in any Federal Health Care Program. None of the Company and its Subsidiaries, nor any officer, director, managing employee or, to the knowledge of Company and its Subsidiaries, any or agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, nor to the knowledge of Company and its Subsidiaries, any Loan Party Partner, has been debarred, excluded, disqualified or suspended from participation in any Federal Health Care Program or under any FDA Laws, Federal Healthcare Program Laws or Public Health Laws (including 21 U.S.C. § 335a). (c) None of Company and its Subsidiaries, nor any officer, director, managing employee or, to the knowledge of Company and its Subsidiaries, any agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, nor to the knowledge of Company and its Subsidiaries, any Loan Party Partner, has engaged in any activity that is in material violation of any Federal Health Care Program Laws, including the following: (i) knowingly and willfully making or causing to be made a false statement or representation of a material fact in any application for any benefit or payment; (ii) knowingly and willfully making or causing to be made a false statement or representation of a material fact for use in determining rights to any benefit or payment; (iii) knowingly and willfully soliciting or receiving any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or kind (1) in return for referring an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under any Federal Health Care Program; or (2) in return for purchasing, leasing, or ordering, or arranging, or arranging for or recommending purchasing, leasing, or ordering any good, facility, service or item for which payment may be made in whole or in part under any Federal Health Care Program; or (iv) knowingly and willfully offering or paying any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to any person to induce such person (1) to refer an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal Health Care Program; or (2) to purchase, lease, order or arrange for or recommend purchasing, leasing or ordering any good, facility, service or item for which payment may be made in whole or in part under a Federal Health Care Program. (d) To the knowledge of Company and its Subsidiaries, no person has filed or has threatened to file against Company or any of its Subsidiaries, an action relating to any FDA Law, Public Health Law or Federal Health Care Program Law under any whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.) that would adversely affect the rights, remedies and benefits available to, or conferred upon, Administrative Agent and any Lender or any other Secured Party under any Loan Document in any material respect. (e) To the extent applicable, each of Company and its Subsidiaries is in compliance in all material respects with HIPAA, and the provisions of all business associate agreements (as such term is defined by HIPAA) to which it is a party, and has implemented reasonably adequate policies, procedures and training designed to assure continued compliance and to detect non-compliance, except where the failure to implement such policies, procedures, and training would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.

Healthcare Regulatory Laws. (a) None of Company Borrower and its Subsidiaries, nor nor, to their knowledge, any officer, director, managing employee or, to the knowledge of Company and its Subsidiaries, or agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, is a party to, or bound by, any written order, individual integrity agreement, corporate integrity agreement, deferred or non-prosecution agreement or other formal written agreement with any Governmental Authority concerning their compliance with Federal Health Care Program Laws. (b) None of Company Borrower and its Subsidiaries, nor any officer, director, managing employee or, to the knowledge of Company and its Subsidiaries, or agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, nor to the knowledge of Company Borrower and its Subsidiaries, any Loan Party Partner: (i) is currently has been, since [**], charged with or has been convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program; (ii) has had had, since [**], a civil monetary penalty assessed against it, him or her them under Section 1128A of the SSASocial Security Act; (iii) has been listed on the U.S. General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; or (iv) to the knowledge of Company Borrower and its Subsidiaries, is the target or subject of any current or potential suit, claim, action, proceeding, arbitration, mediation, inquiry, subpoena or investigation relating to any of the foregoing or any Federal Health Care Program-related offense, or which could result in the imposition of material penalties or the debarment, suspension or exclusion from participation in any Federal Health Care Program. None of Company Borrower and its Subsidiaries, nor any officer, director, managing employee oror agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, to nor any Loan Party Partner, has, as of the knowledge Closing Date, been debarred, excluded, disqualified or suspended from participation in any Federal Health Care Program or under any FDA Laws (including 21 U.S.C. § 335a). (c) None of Company Borrower and its Subsidiaries, nor any officer, director, managing employee or agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, nor to the knowledge of Company Borrower and its Subsidiaries, any Loan Party Partner, has been debarredhas, excludedsince [**], disqualified violated or suspended from participation in any Federal Health Care Program or under any FDA Laws, Federal Healthcare Program Laws or Public Health Laws (including 21 U.S.C. § 335a). (c) None of Company and its Subsidiaries, nor any officer, director, managing employee or, to the knowledge of Company and its Subsidiaries, any agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, nor to the knowledge of Company and its Subsidiaries, any Loan Party Partner, has engaged in any activity that is in material violation of any Federal Health Care Program LawsLaws or cause for false claims liability, including the following: (i) knowingly and willfully making civil penalties or causing to be made a false statement mandatory or representation of a material fact in any application for any benefit or payment; (ii) knowingly and willfully making or causing to be made a false statement or representation of a material fact for use in determining rights to any benefit or payment; (iii) knowingly and willfully soliciting or receiving any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or kind (1) in return for referring an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under permissive exclusion from any Federal Health Care Program; or (2) in return for purchasing, leasingexcept where the violation would not reasonably be expected to result, or ordering, or arranging, or arranging for or recommending purchasing, leasing, or ordering any good, facility, service or item for which payment may be made in whole either individually or in part under any Federal Health Care Program; or (iv) knowingly and willfully offering or paying any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertlythe aggregate, in cash or in kind, to any person to induce such person (1) to refer an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal Health Care Program; or (2) to purchase, lease, order or arrange for or recommend purchasing, leasing or ordering any good, facility, service or item for which payment may be made in whole or in part under a Federal Health Care ProgramMaterial Regulatory Liabilities. (d) To the knowledge of Company Borrower and its SubsidiariesSubsidiaries and as of the Closing Date, no person has filed or has threatened in writing to file against Company Borrower or any of its Subsidiaries, an action relating to any FDA Law, Public Health Law or Federal Health Care Program Law under any whistleblower statute, including under without limitation, the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.) that would adversely affect the rights, remedies and benefits available to, or conferred upon, Administrative Agent and any Lender or any other Secured Party under any Loan Document in any material respect). (e) To the extent applicable, each of Company and its Subsidiaries is in compliance in all material respects with HIPAA, and the provisions of all business associate agreements (as such term is defined by HIPAA) to which it is a party, and has implemented reasonably adequate policies, procedures and training designed to assure continued compliance and to detect non-compliance, except where the failure to implement such policies, procedures, and training would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.

Healthcare Regulatory Laws. (a) None of Company Borrower and its Subsidiaries, nor nor, to their knowledge, any officer, director, managing employee or, to the knowledge of Company and its Subsidiaries, or agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, is a party to, or bound by, any written order, individual integrity agreement, corporate integrity agreement, deferred or non-prosecution agreement or other formal written agreement with any Governmental Authority concerning their compliance with Federal Health Care Program Laws. (b) None of Company Borrower and its Subsidiaries, nor any officer, director, managing employee or, to the knowledge of Company and its Subsidiaries, or agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, nor to the knowledge of Company and its Subsidiariesthe Loan Parties, any Loan Party Partner: (i) is currently has been, since [**], charged with or has been convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program; (ii) has had had, since [**], a civil monetary penalty assessed against it, him or her them under Section 1128A of the SSASocial Security Act; (iii) has been listed on the U.S. General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; or (iv) to the knowledge of Company and its Subsidiariesthe Loan Parties, is the target or subject of any current or potential suit, claim, action, proceeding, arbitration, mediation, inquiry, subpoena or investigation relating to any of the foregoing or any Federal Health Care Program-Program- related offense, or which could result in the imposition of material penalties or the debarment, suspension or exclusion from participation in any Federal Health Care Program. None of Company Borrower and its Subsidiaries, nor any officer, director, managing employee or, to the knowledge of Company and its Subsidiaries, any or agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, nor to the knowledge of Company and its Subsidiaries, any Loan Party Partner, has been debarred, excluded, disqualified or suspended from participation in any Federal Health Care Program or under any FDA Laws, Federal Healthcare Program Laws or Public Health Laws (including 21 U.S.C. § 335a). (c) None of Company Borrower and its Subsidiaries, nor any officer, director, managing employee or, to the knowledge of Company and its Subsidiaries, any or agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, nor to the knowledge of Company and its Subsidiariesthe Loan Parties, any Loan Party Partner, has has, since [**], violated or engaged in any activity that is in material violation of any Federal Health Care Program LawsLaws or cause for false claims liability, including the following: (i) knowingly and willfully making civil penalties or causing to be made a false statement mandatory or representation of a material fact in any application for any benefit or payment; (ii) knowingly and willfully making or causing to be made a false statement or representation of a material fact for use in determining rights to any benefit or payment; (iii) knowingly and willfully soliciting or receiving any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or kind (1) in return for referring an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under permissive exclusion from any Federal Health Care Program; or (2) in return for purchasing, leasingexcept where the violation would not reasonably be expected to result, or ordering, or arranging, or arranging for or recommending purchasing, leasing, or ordering any good, facility, service or item for which payment may be made in whole either individually or in part under any Federal Health Care Program; or (iv) knowingly and willfully offering or paying any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertlythe aggregate, in cash or in kind, to any person to induce such person (1) to refer an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal Health Care Program; or (2) to purchase, lease, order or arrange for or recommend purchasing, leasing or ordering any good, facility, service or item for which payment may be made in whole or in part under a Federal Health Care ProgramMaterial Regulatory Liabilities. (d) To the knowledge of Company and its Subsidiariesthe Loan Parties, no person has filed or has threatened to file against Company Borrower or any of its Subsidiaries, an action relating to any FDA Law, Public Health Law or Federal Health Care Program Law under any whistleblower statute, including under without limitation, the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.) that would adversely affect the rights, remedies and benefits available to, or conferred upon, Administrative Agent and any Lender or any other Secured Party under any Loan Document in any material respect). (e) To the extent applicable, each of Company and its Subsidiaries is in compliance in all material respects with HIPAA, and the provisions of all business associate agreements (as such term is defined by HIPAA) to which it is a party, and has implemented reasonably adequate policies, procedures and training designed to assure continued compliance and to detect non-compliance, except where the failure to implement such policies, procedures, and training would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.

Healthcare Regulatory Laws. (a) None of Company the Borrower and its Subsidiaries, nor nor, to their knowledge, any officer, director, managing employee or, to the knowledge of Company and its Subsidiaries, or agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, is a party to, or bound by, any written order, individual integrity agreement, corporate integrity agreement, deferred or non-prosecution agreement or other formal written agreement with any Governmental Authority concerning their compliance with Federal Health Care Program LawsLaws in any material respect. (b) None of Company and the Borrower, its Subsidiaries, nor or any officer, director, managing employee or, to the knowledge of Company and its Subsidiariesthe Borrower, agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, nor to the knowledge of Company and its Subsidiaries, or any Loan Party Partner: (i) is currently charged with or has been been, since [***], convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program; (ii) has had had, since [***], a civil monetary penalty assessed against it, him or her under Section 1128A of the SSASocial Security Act; (iii) has been listed on the U.S. General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; or (iv) to the knowledge of Company the Borrower and its Subsidiaries, is the target or subject of any current or potential suit, claim, action, proceeding, arbitration, mediation, inquiry, subpoena or investigation relating to any of the foregoing or any Federal Health Care | Program-related offense, or which could result in the imposition of material penalties or the debarment, suspension or exclusion from participation in any Federal Health Care Program. None Since [***], none of Company and the Borrower, its Subsidiaries, nor or any officer, director, managing employee or, to the knowledge of Company and its Subsidiariesthe Borrower, any agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, nor to the knowledge of Company and its Subsidiaries, any Loan Party Partner, thereof has been debarred, excluded, disqualified or suspended from participation in any Federal Health Care Program or under any FDA Laws, Federal Healthcare Program Laws or Public Health Laws (including 21 U.S.C. § 335a). (c) None of Company the Borrower and its Subsidiaries, nor to the knowledge of the Borrower, any officer, director, managing employee or, to the knowledge of Company and its Subsidiaries, any or agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, nor to the knowledge of Company the Borrower and its Subsidiaries, any Loan Party Partner, has engaged in any activity that is in material violation of has, since [***], violated any Federal Health Care Program Laws, including except where the following: (i) knowingly and willfully making violation would not reasonably be expected to result, either individually or causing to be made a false statement or representation of a material fact in any application for any benefit or payment; (ii) knowingly and willfully making or causing to be made a false statement or representation of a material fact for use in determining rights to any benefit or payment; (iii) knowingly and willfully soliciting or receiving any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertlythe aggregate, in cash or kind (1) in return for referring an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under any Federal Health Care Program; or (2) in return for purchasing, leasing, or ordering, or arranging, or arranging for or recommending purchasing, leasing, or ordering any good, facility, service or item for which payment may be made in whole or in part under any Federal Health Care Program; or (iv) knowingly and willfully offering or paying any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to any person to induce such person (1) to refer an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal Health Care Program; or (2) to purchase, lease, order or arrange for or recommend purchasing, leasing or ordering any good, facility, service or item for which payment may be made in whole or in part under a Federal Health Care ProgramMaterial Regulatory Liabilities. (d) To the knowledge of Company the Borrower and its Subsidiaries, since [***], no person has filed or has threatened to file in writing against Company the Borrower or any of its Subsidiaries, an action relating to any FDA Law, Public Health Law or Federal Health Care Program Law under any whistleblower statute, including under without limitation, the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.) that would adversely affect the rights, remedies and benefits available to, or conferred upon, Administrative Agent and any Lender or any other Secured Party under any Loan Document in any material respect). (e) To the extent applicable, each of Company and its Subsidiaries is in compliance in all material respects with HIPAA, and the provisions of all business associate agreements (as such term is defined by HIPAA) to which it is a party, and has implemented reasonably adequate policies, procedures and training designed to assure continued compliance and to detect non-compliance, except where the failure to implement such policies, procedures, and training would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.

Healthcare Regulatory Laws. (a) None of Company the Borrower and its Subsidiaries, nor nor, to their knowledge, any officer, director, managing employee or, to the knowledge of Company and its Subsidiaries, or agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, is a party to, or bound by, any written order, individual integrity agreement, corporate integrity agreement, deferred or non-prosecution agreement or other formal written agreement with any Governmental Authority concerning their compliance with Federal Health Care Program LawsLaws in any material respect. (b) None of Company and the Borrower, its Subsidiaries, nor or any officer, director, managing employee or, to the knowledge of Company and its Subsidiariesthe Borrower, agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, nor to the knowledge of Company and its Subsidiaries, or any Loan Party Partner: (i) is currently charged with or has been been, since [***], convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program; (ii) has had had, since [***], a civil monetary penalty assessed against it, him or her under Section 1128A of the SSASocial Security Act; (iii) has been listed on the U.S. General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; or (iv) to the knowledge of Company the Borrower and its Subsidiaries, is the target or subject of any current or potential suit, claim, action, proceeding, arbitration, mediation, inquiry, subpoena or investigation relating to any of the foregoing or any Federal Health Care Program-related offense, or which could result in the imposition of material penalties or the debarment, suspension or exclusion from participation in any Federal Health Care Program. None Since [***], none of Company and the Borrower, its Subsidiaries, nor or any officer, director, managing employee or, to the knowledge of Company and its Subsidiariesthe Borrower, any agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, nor to the knowledge of Company and its Subsidiaries, any Loan Party Partner, thereof has been debarred, excluded, disqualified or suspended from participation in any Federal Health Care Program or under any FDA Laws, Federal Healthcare Program Laws or Public Health Laws (including 21 U.S.C. § 335a). (c) None of Company the Borrower and its Subsidiaries, nor to the knowledge of the Borrower, any officer, director, managing employee or, to the knowledge of Company and its Subsidiaries, any or agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, nor to the knowledge of Company the Borrower and its Subsidiaries, any Loan Party Partner, has engaged in any activity that is in material violation of has, since [***], violated any Federal Health Care Program Laws, including except where the following: (i) knowingly and willfully making violation would not reasonably be expected to result, either individually or causing to be made a false statement or representation of a material fact in any application for any benefit or payment; (ii) knowingly and willfully making or causing to be made a false statement or representation of a material fact for use in determining rights to any benefit or payment; (iii) knowingly and willfully soliciting or receiving any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertlythe aggregate, in cash or kind (1) in return for referring an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under any Federal Health Care Program; or (2) in return for purchasing, leasing, or ordering, or arranging, or arranging for or recommending purchasing, leasing, or ordering any good, facility, service or item for which payment may be made in whole or in part under any Federal Health Care Program; or (iv) knowingly and willfully offering or paying any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to any person to induce such person (1) to refer an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal Health Care Program; or (2) to purchase, lease, order or arrange for or recommend purchasing, leasing or ordering any good, facility, service or item for which payment may be made in whole or in part under a Federal Health Care ProgramMaterial Regulatory Liabilities. (d) To the knowledge of Company the Borrower and its Subsidiaries, since [***], no person has filed or has threatened to file in writing against Company the Borrower or any of its Subsidiaries, an action relating to any FDA Law, Public Health Law or Federal Health Care Program Law under any whistleblower statute, including under without limitation, the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.) that would adversely affect the rights, remedies and benefits available to, or conferred upon, Administrative Agent and any Lender or any other Secured Party under any Loan Document in any material respect). (e) To the extent applicable, each of Company and its Subsidiaries is in compliance in all material respects with HIPAA, and the provisions of all business associate agreements (as such term is defined by HIPAA) to which it is a party, and has implemented reasonably adequate policies, procedures and training designed to assure continued compliance and to detect non-compliance, except where the failure to implement such policies, procedures, and training would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.