Compliance with Laws and Orders. (a) The Company and its Subsidiaries are in compliance and since April 25, 2021 have been in compliance with all Laws (including all Health Care Laws) and Orders applicable to the Company or any of its Subsidiaries or any assets owned or used by any of them (except for any such past noncompliance as has been remedied and imposes no continuing obligations or costs on the Company or its Subsidiaries), except where any such non-compliance, individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect. Neither the Company nor any of its Subsidiaries has received any written communication since April 25, 2021, from any Governmental Entity that alleges that the Company or any of its Subsidiaries is not in compliance with any such Law or Order, except where any such non-compliance, individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect. (b) Since April 25, 2021, there has not been and currently there is no Proceeding pending against the Company or any of its Subsidiaries under any federal or state whistleblower statute, including under the False Claims Act, 31 U.S.C. §§ 3729-3733 and to the Knowledge of the Company, no such Proceeding has been threatened. Neither the Company nor any of its Subsidiaries is a party to or has any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity with respect to any Health Care Law. (c) Neither the Company nor any of its Subsidiaries has, since April 25, 2021, received or retained any payment in violation of applicable Health Care Laws or legally enforceable Health Care Program requirements (except for any such past violation as has been remedied and imposes no continuing obligations or costs on the Company or its Subsidiaries), except where any such violation, individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect. (d) Since April 25, 2021, the Company and its Subsidiaries have not (i) had any product or manufacturing site (whether Company- or Subsidiary-owned) subject to a Governmental Entity (including the U.S. Food and Drug Administration (“FDA”)) shutdown or import or export prohibition, nor (ii) received any FDA Form 483 or other notice from a Governmental Entity of inspectional observations, notice of adverse finding, notice of violation, “warning letters,” “untitled letters” or requests or requirements to make changes to the products that if not complied with would reasonably be expected to have a Company Material Adverse Effect, and, to the Knowledge of the Company, no Governmental Entity has threatened any such action. (e) The Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors have maintained and filed with the FDA and other Governmental Entities all material reports, data, documents, forms, notices, applications, records and claims that are necessary to comply in all material respects with applicable Health Care Laws. To the Knowledge of the Company, all such reports, data, documents, forms, notices, applications, records, claims, and other filings to the FDA and any similar Governmental Entity by the Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, have been updated to be true, accurate and complete in all material respects as of the date of such update. (f) None of the Company and its Subsidiaries, or their respective affiliates or, to the Knowledge of the Company, their employees, agents, or contractors is the subject of any pending or, to the Knowledge of the Company, threatened Proceeding in respect of the Company, its Subsidiaries, or any Company Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. (g) None of the Company and its Subsidiaries, or their respective affiliates or their officers, employees, agents, or contractors has been suspended, excluded, debarred, or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. §§ 335(a)–(b) or any similar Law, (ii) exclusion under 42 U.S.C. § 1320a-7 in any federal or state health care program or any similar Law, (iii) prohibition from participating in any procurement program of or otherwise contracting with any Governmental Entity, or (iv) assessment of penalties under any Health Care Law, nor are any such advanced actions threatened or reasonably foreseeable. As of the date hereof, no Proceedings that would reasonably be expected to result in any such material debarment, exclusion, prohibition, or assessment of penalties are pending or, to the Knowledge of the Company, threatened against the Company, its Subsidiaries, or any of their respective affiliates or their officers, employees, agents, or contractors. (h) The Company and its Subsidiaries, and their respective affiliates have in place an operational regulatory compliance program that governs all employees, agents, and contractors and that is designed to address compliance with all applicable Health Care Laws. The Company and its Subsidiaries, and their respective affiliates operate in compliance with such regulatory compliance program in all material respects, except where noncompliance has not had and would not reasonably be expected to have a Company Material Adverse Effect. (i) Since April 25, 2021, the Company and each of its Subsidiaries, and each of their respective officers, directors, or Employees and, to the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries (i) have at all times been in material compliance with all Laws relating to export, reexport, transfer, and import control, economic and trade sanctions, and trade embargo statutes, regulations, decrees, orders, guidelines and policies of the United States government and the government of any country in which it conducts business including but not limited to the Export Administration Regulations (“EAR”) (15 C.F.R. Parts 730-774 (2022)) of the U.S. Department of Commerce; the U.S. antiboycott regulations and guidelines, including those under the EAR and U.S. Department of the Treasury regulations; the various economic sanctions regulations and guidelines of the U.S. Department of the Treasury, Office of Foreign Assets Control, and the USA Patriot Act (Title III of Pub. L. 107-56, signed into Law October 26, 2001), as amended; and restrictions against dealings with certain prohibited, debarred, denied or specially designated entities or individuals under statutes, regulations, orders, and decrees of various agencies of the United States government (collectively, “Trade Controls”); or (ii) have not engaged in any dealings or transactions with or for the benefit of any Sanctioned Person or in any Sanctioned Country. (j) Neither the Company, nor any of its Subsidiaries, nor any of their respective officers, directors, Employees or, to the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries, has made, offered, promised or authorized any gift or payment of anything of value, directly or indirectly, to or for the benefit of any government official, or any other person, in order to assist the Company in obtaining or retaining business or otherwise securing any improper advantage in violation of applicable Anti-Corruption Laws. (k) Neither the Company nor any of its Subsidiaries has received from any Governmental Entity or any Person any notice, inquiry, or internal or external allegation; made any voluntary or involuntary disclosure to a Governmental Entity; or conducted any internal investigation or audit concerning any actual or potential violation or wrongdoing in each case, related to Trade Controls or Anti-Corruption Laws. (l) Since April 25, 2021 neither the Company nor its Subsidiaries or their respective affiliates or their employees, agents or contractors has entered into any arrangement involving the offering or paying any remuneration (including any kickback, bribe, discount or rebate), directly or indirectly, overtly or covertly in cash or in kind to any Person: (i) in return for referring an individual to the Company or any of its Subsidiaries for the furnishing or arranging for the furnishing of any item, product or services for which payment may be made in whole or in part by any Health Care Program or commercial health insurer; or (ii) in return for purchasing, leasing or ordering or arranging for or recommending, purchasing, leasing or ordering any item, product, facility or service from or to the Company or any of its Subsidiaries for which payment may be made in whole or in part by any Health Care Program or commercial health insurer. There are no current arrangements relating to the Company or any of its Subsidiaries providing for any rebates, kickback or other forms of compensation that are unlawful to be paid to any Person in return for the referral or generation of business to the Company or any of its Subsidiaries or for the arrangement for recommendation of such referrals or business. Since April 25, 2021, the Company enters into written agreements with each of its independent contractor health care providers and sales and marketing personnel in compliance with the AKS Personal Services and Management Contracts safe harbor (as set forth at 42 C.F.R. § 1001.952 (d)). (m) The Company and its Subsidiaries and affiliates are and since April 25, 2021 have been in material compliance with all applicable Healthcare Privacy and Security Laws. Since April 25, 2021, no Breach (as that term is defined in HIPAA) has occurred with respect to any unsecured Protected Health Information (as that term is defined in HIPAA) (“PHI”) maintained by or for the Company, any of its Subsidiaries and affiliates. Since April 25, 2021, the Company, its Subsidiaries and affiliates have not received any notice or complaint from any Person, including any Governmental Entity regarding the unauthorized processing of PHI or non-compliance with applicable Healthcare Privacy and Security Laws. Neither the Company, nor its Subsidiaries and their respective affiliates engage in the sale of PHI, as the term “sale” is defined by applicable law.
Appears in 2 contracts
Samples: Merger Agreement (Patterson Companies, Inc.), Merger Agreement (Patterson Companies, Inc.)
Compliance with Laws and Orders. (a) The Company Parent and its Subsidiaries are in compliance hold all permits, licenses, variances, exemptions, orders and since April 25, 2021 have been in compliance with approvals (other than FCC Licenses) of all Laws Governmental and Regulatory Authorities necessary for the lawful conduct of the Parent Station Business (including all Health Care Laws) and Orders applicable to the Company or any of its Subsidiaries or any assets owned or used by any of them (except for any such past noncompliance as has been remedied and imposes no continuing obligations or costs on the Company or its Subsidiaries"Parent Permits"), except where any for failures to hold such non-compliancepermits, licenses, variances, exemptions, orders and approvals which, individually or in the aggregate, has are not had, having and would could not be reasonably be expected to have, have a Company Parent Material Adverse Effect. Neither the Company nor any of Parent and its Subsidiaries has received any written communication since April 25, 2021, from any Governmental Entity that alleges that the Company or any of its Subsidiaries is not are in compliance with any such Law or Orderthe terms of the Parent Permits, except where any such non-compliancefailures so to comply which, individually or in the aggregate, has are not had, having and would could not be reasonably be expected to havehave a Parent Material Adverse Effect. Parent and its Subsidiaries are not in violation of any Law or Order of any Governmental or Regulatory Authority which relates to the Parent Station Business, except for violations which, individually or in the aggregate, are not having and could not be reasonably expected to have a Company Parent Material Adverse Effect.
(b) Since April 25, 2021, there has Except as does not been and currently there is no Proceeding pending against materially jeopardize the Company or operation by Parent of any of its Subsidiaries under any federal or state whistleblower statute, including under the False Claims Act, 31 U.S.C. §§ 3729-3733 and Parent Stations to which FCC Licenses apply: (i) to the Knowledge knowledge of Parent, Parent is qualified to hold such FCC Licenses or to control such FCC Licenses, as the Company, no case may be; (ii) Parent holds such Proceeding has been threatened. Neither the Company nor any of its Subsidiaries is a party to or has any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity FCC Licenses; (iii) except as provided in Section 8.06 with respect to any Health Care Law.
(c) Neither the Company nor any divestiture of its Subsidiaries hascertain assets described therein, since April 25, 2021, received or retained any payment in violation of applicable Health Care Laws or legally enforceable Health Care Program requirements (except for any such past violation as has been remedied and imposes no continuing obligations or costs on the Company or its Subsidiaries), except where any such violation, individually or in the aggregate, has Parent is not had, and would not reasonably be expected to have, a Company Material Adverse Effect.
(d) Since April 25, 2021, the Company and its Subsidiaries have not (i) had any product or manufacturing site (whether Company- or Subsidiary-owned) subject to a Governmental Entity (including the U.S. Food and Drug Administration (“FDA”)) shutdown or import or export prohibition, nor (ii) received any FDA Form 483 or other notice from a Governmental Entity of inspectional observations, notice of adverse finding, notice of violation, “warning letters,” “untitled letters” or requests or requirements to make changes to the products that if not complied with would reasonably be expected to have a Company Material Adverse Effect, and, to the Knowledge of the Company, no Governmental Entity has threatened any such action.
(e) The Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors have maintained and filed with the FDA and other Governmental Entities all material reports, data, documents, forms, notices, applications, records and claims that are necessary to comply in all material respects with applicable Health Care Laws. To the Knowledge of the Company, all such reports, data, documents, forms, notices, applications, records, claims, and other filings to the FDA and any similar Governmental Entity by the Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, have been updated to be true, accurate and complete in all material respects as of the date of such update.
(f) None of the Company and its Subsidiaries, or their respective affiliates or, to the Knowledge of the Company, their employees, agents, or contractors is the subject aware of any facts or circumstances relating to Parent that would prevent the granting of FCC Approval; (iv) each Parent Station is in material compliance with all FCC Licenses held by it; and (v) there is not pending or, to the Knowledge knowledge of the CompanyParent, threatened Proceeding in respect of any application, petition, objection or other pleading with the Company, its SubsidiariesFCC or other Governmental or Regulatory Authority which challenges the validity of, or any Company Productsrights of the holder under, any FCC License held by the FDA pursuant Parent Stations, except for rule making or similar proceedings of general applicability to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto.
(g) None of the Company and its Subsidiaries, or their respective affiliates or their officers, employees, agents, or contractors has been suspended, excluded, debarred, or convicted of any crime or persons engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. §§ 335(a)–(b) or any similar Law, (ii) exclusion under 42 U.S.C. § 1320a-7 in any federal or state health care program or any similar Law, (iii) prohibition from participating in any procurement program of or otherwise contracting with any Governmental Entity, or (iv) assessment of penalties under any Health Care Law, nor are any such advanced actions threatened or reasonably foreseeable. As of substantially the date hereof, no Proceedings that would reasonably be expected to result in any such material debarment, exclusion, prohibition, or assessment of penalties are pending or, to same business conducted by the Knowledge of the Company, threatened against the Company, its Subsidiaries, or any of their respective affiliates or their officers, employees, agents, or contractorsParent Stations.
(h) The Company and its Subsidiaries, and their respective affiliates have in place an operational regulatory compliance program that governs all employees, agents, and contractors and that is designed to address compliance with all applicable Health Care Laws. The Company and its Subsidiaries, and their respective affiliates operate in compliance with such regulatory compliance program in all material respects, except where noncompliance has not had and would not reasonably be expected to have a Company Material Adverse Effect.
(i) Since April 25, 2021, the Company and each of its Subsidiaries, and each of their respective officers, directors, or Employees and, to the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries (i) have at all times been in material compliance with all Laws relating to export, reexport, transfer, and import control, economic and trade sanctions, and trade embargo statutes, regulations, decrees, orders, guidelines and policies of the United States government and the government of any country in which it conducts business including but not limited to the Export Administration Regulations (“EAR”) (15 C.F.R. Parts 730-774 (2022)) of the U.S. Department of Commerce; the U.S. antiboycott regulations and guidelines, including those under the EAR and U.S. Department of the Treasury regulations; the various economic sanctions regulations and guidelines of the U.S. Department of the Treasury, Office of Foreign Assets Control, and the USA Patriot Act (Title III of Pub. L. 107-56, signed into Law October 26, 2001), as amended; and restrictions against dealings with certain prohibited, debarred, denied or specially designated entities or individuals under statutes, regulations, orders, and decrees of various agencies of the United States government (collectively, “Trade Controls”); or (ii) have not engaged in any dealings or transactions with or for the benefit of any Sanctioned Person or in any Sanctioned Country.
(j) Neither the Company, nor any of its Subsidiaries, nor any of their respective officers, directors, Employees or, to the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries, has made, offered, promised or authorized any gift or payment of anything of value, directly or indirectly, to or for the benefit of any government official, or any other person, in order to assist the Company in obtaining or retaining business or otherwise securing any improper advantage in violation of applicable Anti-Corruption Laws.
(k) Neither the Company nor any of its Subsidiaries has received from any Governmental Entity or any Person any notice, inquiry, or internal or external allegation; made any voluntary or involuntary disclosure to a Governmental Entity; or conducted any internal investigation or audit concerning any actual or potential violation or wrongdoing in each case, related to Trade Controls or Anti-Corruption Laws.
(l) Since April 25, 2021 neither the Company nor its Subsidiaries or their respective affiliates or their employees, agents or contractors has entered into any arrangement involving the offering or paying any remuneration (including any kickback, bribe, discount or rebate), directly or indirectly, overtly or covertly in cash or in kind to any Person: (i) in return for referring an individual to the Company or any of its Subsidiaries for the furnishing or arranging for the furnishing of any item, product or services for which payment may be made in whole or in part by any Health Care Program or commercial health insurer; or (ii) in return for purchasing, leasing or ordering or arranging for or recommending, purchasing, leasing or ordering any item, product, facility or service from or to the Company or any of its Subsidiaries for which payment may be made in whole or in part by any Health Care Program or commercial health insurer. There are no current arrangements relating to the Company or any of its Subsidiaries providing for any rebates, kickback or other forms of compensation that are unlawful to be paid to any Person in return for the referral or generation of business to the Company or any of its Subsidiaries or for the arrangement for recommendation of such referrals or business. Since April 25, 2021, the Company enters into written agreements with each of its independent contractor health care providers and sales and marketing personnel in compliance with the AKS Personal Services and Management Contracts safe harbor (as set forth at 42 C.F.R. § 1001.952 (d)).
(m) The Company and its Subsidiaries and affiliates are and since April 25, 2021 have been in material compliance with all applicable Healthcare Privacy and Security Laws. Since April 25, 2021, no Breach (as that term is defined in HIPAA) has occurred with respect to any unsecured Protected Health Information (as that term is defined in HIPAA) (“PHI”) maintained by or for the Company, any of its Subsidiaries and affiliates. Since April 25, 2021, the Company, its Subsidiaries and affiliates have not received any notice or complaint from any Person, including any Governmental Entity regarding the unauthorized processing of PHI or non-compliance with applicable Healthcare Privacy and Security Laws. Neither the Company, nor its Subsidiaries and their respective affiliates engage in the sale of PHI, as the term “sale” is defined by applicable law.
Appears in 2 contracts
Samples: Merger Agreement (Hearst Corp), Merger Agreement (Argyle Television Inc)
Compliance with Laws and Orders. The Company and each Subsidiary of the Company is in compliance with all applicable laws of all Governmental or Regulatory Authorities applicable to them except when such failure to comply, individually or in the aggregate, are not having and could not be reasonably expected to have a material adverse effect on the Company and its Subsidiaries taken as a whole or on the ability of the Company to consummate the transactions contemplated hereby. The Company and its Subsidiaries hold all permits, licenses, variances, exemptions, orders and approvals of all Governmental and Regulatory Authorities necessary for the lawful conduct of their respective businesses (a) the "Company Permits"), except for failures to hold such permits, licenses, variances, exemptions, orders and approvals which, individually or in the aggregate, are not having and could not be reasonably expected to have a material adverse effect on the Company and its Subsidiaries taken as a whole. The Company and its Subsidiaries are in compliance and since April 25, 2021 have been in compliance with all Laws (including all Health Care Laws) and Orders applicable to the terms of the Company or any of its Subsidiaries or any assets owned or used by any of them (except for any such past noncompliance as has been remedied and imposes no continuing obligations or costs on the Company or its Subsidiaries)Permits, except where any such non-compliancefailures so to comply which, individually or in the aggregate, has are not had, having and would could not be reasonably be expected to have, have a Company Material Adverse Effect. Neither material adverse effect on the Company nor any of and its Subsidiaries has received taken as a whole. Except as disclosed in the Company SEC Reports filed prior to the date of this Agreement, the Company and its Subsidiaries are not in violation of or default under any written communication since April 25, 2021, from law or order of any Governmental Entity that alleges that the Company or any of its Subsidiaries is not in compliance with any such Law or OrderRegulatory Authority, except where any for such non-complianceviolations or defaults which, individually or in the aggregate, has are not had, having and would could not be reasonably be expected to have, have a Company Material Adverse Effect.
(b) Since April 25, 2021, there has not been and currently there is no Proceeding pending against the Company or any of its Subsidiaries under any federal or state whistleblower statute, including under the False Claims Act, 31 U.S.C. §§ 3729-3733 and to the Knowledge of the Company, no such Proceeding has been threatened. Neither the Company nor any of its Subsidiaries is a party to or has any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity with respect to any Health Care Law.
(c) Neither the Company nor any of its Subsidiaries has, since April 25, 2021, received or retained any payment in violation of applicable Health Care Laws or legally enforceable Health Care Program requirements (except for any such past violation as has been remedied and imposes no continuing obligations or costs material adverse effect on the Company or its Subsidiaries), except where any such violation, individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect.
(d) Since April 25, 2021, the Company and its Subsidiaries have not (i) had any product taken as a whole or manufacturing site (whether Company- or Subsidiary-owned) subject to a Governmental Entity (including on the U.S. Food and Drug Administration (“FDA”)) shutdown or import or export prohibition, nor (ii) received any FDA Form 483 or other notice from a Governmental Entity of inspectional observations, notice of adverse finding, notice of violation, “warning letters,” “untitled letters” or requests or requirements to make changes to the products that if not complied with would reasonably be expected to have a Company Material Adverse Effect, and, to the Knowledge of the Company, no Governmental Entity has threatened any such action.
(e) The Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors have maintained and filed with the FDA and other Governmental Entities all material reports, data, documents, forms, notices, applications, records and claims that are necessary to comply in all material respects with applicable Health Care Laws. To the Knowledge of the Company, all such reports, data, documents, forms, notices, applications, records, claims, and other filings to the FDA and any similar Governmental Entity by the Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, have been updated to be true, accurate and complete in all material respects as of the date of such update.
(f) None ability of the Company and its Subsidiaries, or their respective affiliates or, to consummate the Knowledge of the Company, their employees, agents, or contractors is the subject of any pending or, to the Knowledge of the Company, threatened Proceeding in respect of the Company, its Subsidiaries, or any Company Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments theretotransactions contemplated hereby.
(g) None of the Company and its Subsidiaries, or their respective affiliates or their officers, employees, agents, or contractors has been suspended, excluded, debarred, or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. §§ 335(a)–(b) or any similar Law, (ii) exclusion under 42 U.S.C. § 1320a-7 in any federal or state health care program or any similar Law, (iii) prohibition from participating in any procurement program of or otherwise contracting with any Governmental Entity, or (iv) assessment of penalties under any Health Care Law, nor are any such advanced actions threatened or reasonably foreseeable. As of the date hereof, no Proceedings that would reasonably be expected to result in any such material debarment, exclusion, prohibition, or assessment of penalties are pending or, to the Knowledge of the Company, threatened against the Company, its Subsidiaries, or any of their respective affiliates or their officers, employees, agents, or contractors.
(h) The Company and its Subsidiaries, and their respective affiliates have in place an operational regulatory compliance program that governs all employees, agents, and contractors and that is designed to address compliance with all applicable Health Care Laws. The Company and its Subsidiaries, and their respective affiliates operate in compliance with such regulatory compliance program in all material respects, except where noncompliance has not had and would not reasonably be expected to have a Company Material Adverse Effect.
(i) Since April 25, 2021, the Company and each of its Subsidiaries, and each of their respective officers, directors, or Employees and, to the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries (i) have at all times been in material compliance with all Laws relating to export, reexport, transfer, and import control, economic and trade sanctions, and trade embargo statutes, regulations, decrees, orders, guidelines and policies of the United States government and the government of any country in which it conducts business including but not limited to the Export Administration Regulations (“EAR”) (15 C.F.R. Parts 730-774 (2022)) of the U.S. Department of Commerce; the U.S. antiboycott regulations and guidelines, including those under the EAR and U.S. Department of the Treasury regulations; the various economic sanctions regulations and guidelines of the U.S. Department of the Treasury, Office of Foreign Assets Control, and the USA Patriot Act (Title III of Pub. L. 107-56, signed into Law October 26, 2001), as amended; and restrictions against dealings with certain prohibited, debarred, denied or specially designated entities or individuals under statutes, regulations, orders, and decrees of various agencies of the United States government (collectively, “Trade Controls”); or (ii) have not engaged in any dealings or transactions with or for the benefit of any Sanctioned Person or in any Sanctioned Country.
(j) Neither the Company, nor any of its Subsidiaries, nor any of their respective officers, directors, Employees or, to the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries, has made, offered, promised or authorized any gift or payment of anything of value, directly or indirectly, to or for the benefit of any government official, or any other person, in order to assist the Company in obtaining or retaining business or otherwise securing any improper advantage in violation of applicable Anti-Corruption Laws.
(k) Neither the Company nor any of its Subsidiaries has received from any Governmental Entity or any Person any notice, inquiry, or internal or external allegation; made any voluntary or involuntary disclosure to a Governmental Entity; or conducted any internal investigation or audit concerning any actual or potential violation or wrongdoing in each case, related to Trade Controls or Anti-Corruption Laws.
(l) Since April 25, 2021 neither the Company nor its Subsidiaries or their respective affiliates or their employees, agents or contractors has entered into any arrangement involving the offering or paying any remuneration (including any kickback, bribe, discount or rebate), directly or indirectly, overtly or covertly in cash or in kind to any Person: (i) in return for referring an individual to the Company or any of its Subsidiaries for the furnishing or arranging for the furnishing of any item, product or services for which payment may be made in whole or in part by any Health Care Program or commercial health insurer; or (ii) in return for purchasing, leasing or ordering or arranging for or recommending, purchasing, leasing or ordering any item, product, facility or service from or to the Company or any of its Subsidiaries for which payment may be made in whole or in part by any Health Care Program or commercial health insurer. There are no current arrangements relating to the Company or any of its Subsidiaries providing for any rebates, kickback or other forms of compensation that are unlawful to be paid to any Person in return for the referral or generation of business to the Company or any of its Subsidiaries or for the arrangement for recommendation of such referrals or business. Since April 25, 2021, the Company enters into written agreements with each of its independent contractor health care providers and sales and marketing personnel in compliance with the AKS Personal Services and Management Contracts safe harbor (as set forth at 42 C.F.R. § 1001.952 (d)).
(m) The Company and its Subsidiaries and affiliates are and since April 25, 2021 have been in material compliance with all applicable Healthcare Privacy and Security Laws. Since April 25, 2021, no Breach (as that term is defined in HIPAA) has occurred with respect to any unsecured Protected Health Information (as that term is defined in HIPAA) (“PHI”) maintained by or for the Company, any of its Subsidiaries and affiliates. Since April 25, 2021, the Company, its Subsidiaries and affiliates have not received any notice or complaint from any Person, including any Governmental Entity regarding the unauthorized processing of PHI or non-compliance with applicable Healthcare Privacy and Security Laws. Neither the Company, nor its Subsidiaries and their respective affiliates engage in the sale of PHI, as the term “sale” is defined by applicable law.
Appears in 2 contracts
Samples: Merger Agreement (Alpnet Inc), Merger Agreement (Alpnet Inc)
Compliance with Laws and Orders. (a) The Company Parent and its Subsidiaries are in compliance and since April 25, 2021 have been each Subsidiary of the Parent is in compliance with all Laws (including applicable laws of all Health Care Laws) and Orders Governmental or Regulatory Authorities applicable to the Company or any of its Subsidiaries or any assets owned or used by any of them (except for any when such past noncompliance as has been remedied and imposes no continuing obligations or costs on the Company or its Subsidiaries), except where any such non-compliancefailure to comply, individually or in the aggregate, has are not had, having and would could not be reasonably be expected to have, have a Company Material Adverse Effectmaterial adverse effect on the ability of the Parent to consummate the transactions contemplated by this Agreement. Neither the Company nor any of The Parent and its Subsidiaries has received any written communication since April 25hold all permits, 2021licenses, from any variances, exemptions, orders and approvals of all Governmental Entity that alleges that and Regulatory Authorities necessary for the Company or any lawful conduct of its Subsidiaries is not in compliance with any such Law or Ordertheir respective businesses (the "Parent Permits"), except where any for failures to hold such non-compliancepermits, licenses, variances, exemptions, orders and approvals which, individually or in the aggregate, has are not had, having and would could not be reasonably be expected to have, have a Company Material Adverse Effect.
(b) Since April 25, 2021, there has not been material adverse effect on ability of the Parent to consummate the transactions contemplated by this Agreement. The Parent and currently there is no Proceeding pending against the Company or any of its Subsidiaries under any federal or state whistleblower statute, including under are in compliance with the False Claims Act, 31 U.S.C. §§ 3729-3733 and to the Knowledge terms of the Company, no such Proceeding has been threatened. Neither the Company nor any of its Subsidiaries is a party to or has any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity with respect to any Health Care Law.
(c) Neither the Company nor any of its Subsidiaries has, since April 25, 2021, received or retained any payment in violation of applicable Health Care Laws or legally enforceable Health Care Program requirements (except for any such past violation as has been remedied and imposes no continuing obligations or costs on the Company or its Subsidiaries)Parent Permits, except where any such violationfailures so to comply which, individually or in the aggregate, has are not had, having and would could not be reasonably be expected to have, a Company Material Adverse Effect.
(d) Since April 25, 2021, the Company and its Subsidiaries have not (i) had any product or manufacturing site (whether Company- or Subsidiary-owned) subject to a Governmental Entity (including the U.S. Food and Drug Administration (“FDA”)) shutdown or import or export prohibition, nor (ii) received any FDA Form 483 or other notice from a Governmental Entity of inspectional observations, notice of adverse finding, notice of violation, “warning letters,” “untitled letters” or requests or requirements to make changes to the products that if not complied with would reasonably be expected to have a Company Material Adverse Effect, and, to material adverse effect on the Knowledge of the Company, no Governmental Entity has threatened any such action.
(e) The Company Parent and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors have maintained and Subsidiaries taken as a whole. Except as disclosed in the Parent Securities Reports filed with the FDA and other Governmental Entities all material reports, data, documents, forms, notices, applications, records and claims that are necessary prior to comply in all material respects with applicable Health Care Laws. To the Knowledge of the Company, all such reports, data, documents, forms, notices, applications, records, claims, and other filings to the FDA and any similar Governmental Entity by the Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, have been updated to be true, accurate and complete in all material respects as of the date of such update.
(f) None of this Agreement, the Company Parent and its Subsidiaries, Subsidiaries are not in violation of or their respective affiliates or, to the Knowledge of the Company, their employees, agents, default under any law or contractors is the subject order of any pending or, to the Knowledge of the Company, threatened Proceeding in respect of the Company, its Subsidiaries, Governmental or any Company Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto.
(g) None of the Company and its Subsidiaries, or their respective affiliates or their officers, employees, agents, or contractors has been suspended, excluded, debarred, or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. §§ 335(a)–(b) or any similar Law, (ii) exclusion under 42 U.S.C. § 1320a-7 in any federal or state health care program or any similar Law, (iii) prohibition from participating in any procurement program of or otherwise contracting with any Governmental Entity, or (iv) assessment of penalties under any Health Care Law, nor are any such advanced actions threatened or reasonably foreseeable. As of the date hereof, no Proceedings that would reasonably be expected to result in any such material debarment, exclusion, prohibition, or assessment of penalties are pending or, to the Knowledge of the Company, threatened against the Company, its Subsidiaries, or any of their respective affiliates or their officers, employees, agents, or contractors.
(h) The Company and its Subsidiaries, and their respective affiliates have in place an operational regulatory compliance program that governs all employees, agents, and contractors and that is designed to address compliance with all applicable Health Care Laws. The Company and its Subsidiaries, and their respective affiliates operate in compliance with such regulatory compliance program in all material respectsRegulatory Authority, except where noncompliance has for such violations or defaults which, individually or in the aggregate, are not had having and would could not be reasonably be expected to have a Company Material Adverse Effect.
(i) Since April 25, 2021, material adverse effect on the Company and each of its Subsidiaries, and each of their respective officers, directors, or Employees and, to the Knowledge ability of the Company, any agent or other third party representative acting on behalf of Parent to consummate the Company or any of its Subsidiaries (i) have at all times been in material compliance with all Laws relating to export, reexport, transfer, and import control, economic and trade sanctions, and trade embargo statutes, regulations, decrees, orders, guidelines and policies of the United States government and the government of any country in which it conducts business including but not limited to the Export Administration Regulations (“EAR”) (15 C.F.R. Parts 730-774 (2022)) of the U.S. Department of Commerce; the U.S. antiboycott regulations and guidelines, including those under the EAR and U.S. Department of the Treasury regulations; the various economic sanctions regulations and guidelines of the U.S. Department of the Treasury, Office of Foreign Assets Control, and the USA Patriot Act (Title III of Pub. L. 107-56, signed into Law October 26, 2001), as amended; and restrictions against dealings with certain prohibited, debarred, denied or specially designated entities or individuals under statutes, regulations, orders, and decrees of various agencies of the United States government (collectively, “Trade Controls”); or (ii) have not engaged in any dealings or transactions with or for the benefit of any Sanctioned Person or in any Sanctioned Countrycontemplated hereby.
(j) Neither the Company, nor any of its Subsidiaries, nor any of their respective officers, directors, Employees or, to the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries, has made, offered, promised or authorized any gift or payment of anything of value, directly or indirectly, to or for the benefit of any government official, or any other person, in order to assist the Company in obtaining or retaining business or otherwise securing any improper advantage in violation of applicable Anti-Corruption Laws.
(k) Neither the Company nor any of its Subsidiaries has received from any Governmental Entity or any Person any notice, inquiry, or internal or external allegation; made any voluntary or involuntary disclosure to a Governmental Entity; or conducted any internal investigation or audit concerning any actual or potential violation or wrongdoing in each case, related to Trade Controls or Anti-Corruption Laws.
(l) Since April 25, 2021 neither the Company nor its Subsidiaries or their respective affiliates or their employees, agents or contractors has entered into any arrangement involving the offering or paying any remuneration (including any kickback, bribe, discount or rebate), directly or indirectly, overtly or covertly in cash or in kind to any Person: (i) in return for referring an individual to the Company or any of its Subsidiaries for the furnishing or arranging for the furnishing of any item, product or services for which payment may be made in whole or in part by any Health Care Program or commercial health insurer; or (ii) in return for purchasing, leasing or ordering or arranging for or recommending, purchasing, leasing or ordering any item, product, facility or service from or to the Company or any of its Subsidiaries for which payment may be made in whole or in part by any Health Care Program or commercial health insurer. There are no current arrangements relating to the Company or any of its Subsidiaries providing for any rebates, kickback or other forms of compensation that are unlawful to be paid to any Person in return for the referral or generation of business to the Company or any of its Subsidiaries or for the arrangement for recommendation of such referrals or business. Since April 25, 2021, the Company enters into written agreements with each of its independent contractor health care providers and sales and marketing personnel in compliance with the AKS Personal Services and Management Contracts safe harbor (as set forth at 42 C.F.R. § 1001.952 (d)).
(m) The Company and its Subsidiaries and affiliates are and since April 25, 2021 have been in material compliance with all applicable Healthcare Privacy and Security Laws. Since April 25, 2021, no Breach (as that term is defined in HIPAA) has occurred with respect to any unsecured Protected Health Information (as that term is defined in HIPAA) (“PHI”) maintained by or for the Company, any of its Subsidiaries and affiliates. Since April 25, 2021, the Company, its Subsidiaries and affiliates have not received any notice or complaint from any Person, including any Governmental Entity regarding the unauthorized processing of PHI or non-compliance with applicable Healthcare Privacy and Security Laws. Neither the Company, nor its Subsidiaries and their respective affiliates engage in the sale of PHI, as the term “sale” is defined by applicable law.
Appears in 2 contracts
Samples: Merger Agreement (Alpnet Inc), Merger Agreement (Alpnet Inc)
Compliance with Laws and Orders. (a) The 18.1. None of the Founder nor any shareholders of the Company and its Subsidiaries are in compliance and since April 25, 2021 have is or has been in compliance violation of any applicable statute, rule, regulation, order or restriction of any domestic or foreign government or any instrumentality or agency thereof (“Laws”) in respect of the conduct of its business or the ownership of its properties, including but not limited to the registration requirement for the Founder’s (indirect) investment in the Company under the Circular on Relevant Issues Concerning Foreign Exchange Administration for Domestic Residents to Engage in Overseas Investment, Financing and Round Trip Investment via Special Purpose Companies issued by the State Administration of Foreign Exchange on July 14, 2014 and any successor rule or regulation under PRC law. All consents, licenses, permits, approvals, orders, authorizations or registrations, qualifications, designations, declarations or filings by or with all Laws (including all Health Care Laws) any governmental authority and Orders applicable any third party which are required to be obtained or made by the Company or any of its the Subsidiaries or any assets owned VIE Affiliates in connection with the consummation of the transactions contemplated hereunder shall have been obtained or used by any made prior to and shall be fully effective as of them (except for any such past noncompliance as has been remedied and imposes no continuing obligations or costs on the Closing. Each of the Company and the Subsidiaries and VIE Affiliates has (a) all franchises, permits, licenses and any similar authority necessary for; and (b) complied with all applicable Laws in respect of, the conduct of its business as currently conducted and proposed to be conducted, the absence or its Subsidiaries), except where any such non-compliance, individually or in the aggregate, has not had, and compliance of which would not be reasonably be expected likely to have, have a Company Material Adverse Effect. Neither the Company nor any None of its Subsidiaries has received any written communication since April 25, 2021, from any Governmental Entity that alleges that the Company or any of its the Subsidiaries or VIE Affiliates is not in compliance with default under any of such Law franchises, permits, licenses or Order, except where any such non-compliance, individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effectother similar authority.
(b) Since April 2518.2. None of the Founder, 2021, there has not been and currently there is no Proceeding pending against the Company or any of its the Subsidiaries under or VIE Affiliates is or has at any federal time been, or state whistleblower statutehas received any notice that it is or has at any time been, including under the False Claims Actin violation of or in default under, 31 U.S.C. §§ 3729-3733 and in any material respect, any law applicable to the Knowledge of the Company, no such Proceeding has been threatened. Neither the Company nor any of its the Subsidiaries is a party to or has any ongoing reporting obligations pursuant to VIE Affiliates or under any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity with respect to any Health Care Law.
(c) Neither the Company nor any of its Subsidiaries has, since April 25, 2021, received or retained any payment in violation of applicable Health Care Laws or legally enforceable Health Care Program requirements (except for any such past violation as has been remedied and imposes no continuing obligations or costs on the Company or its Subsidiaries), except where any such violation, individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect.
(d) Since April 25, 2021, the Company and its Subsidiaries have not (i) had any product or manufacturing site (whether Company- or Subsidiary-owned) subject to a Governmental Entity (including the U.S. Food and Drug Administration (“FDA”)) shutdown or import or export prohibition, nor (ii) received any FDA Form 483 or other notice from a Governmental Entity of inspectional observations, notice of adverse finding, notice of violation, “warning letters,” “untitled letters” or requests or requirements to make changes to the products that if not complied with would reasonably be expected to have a Company Material Adverse Effect, and, to the Knowledge of the Company, no Governmental Entity has threatened any such action.
(e) The Company and its Subsidiaries, and their respective affiliates assets and their employeesproperties, agents, and contractors have maintained and filed with the FDA and other Governmental Entities all material reports, data, documents, forms, notices, applications, records and claims that are necessary to comply in all material respects with applicable Health Care Laws. To the Knowledge of the Company, all such reports, data, documents, forms, notices, applications, records, claims, and other filings to the FDA and any similar Governmental Entity by the Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, have been updated to be true, accurate and complete in all material respects as of the date of such update.
(f) None of the Company and its Subsidiaries, or their respective affiliates or, to the Knowledge of the Company, their employees, agents, or contractors is the subject of any pending or, to the Knowledge of the Company, threatened Proceeding in respect of the Company, its Subsidiaries, or any Company Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto.
(g) None of the Company and its Subsidiaries, or their respective affiliates or their officers, employees, agents, or contractors has been suspended, excluded, debarred, or convicted of any crime or engaged in any conduct that each case which would reasonably be expected to result in a Material Adverse Effect.
18.3. None of the Founder, the Company or any of the Subsidiaries or VIE Affiliates or their respective officer, director, employee or agent has acted in violation of any relevant anti-money laundering laws.
18.4. Each of the Company and the Subsidiaries and VIE Affiliates is not currently and has not at any time been in violation of (i) debarment under 21 U.S.C. §§ 335(a)–(b) any applicable law or any similar Lawregulation, (ii) exclusion under 42 U.S.C. § 1320a-7 in any federal order binding upon such Person or state health care program or any similar Law, (iii) prohibition from participating in any procurement program terms of any charter document or otherwise contracting with any Governmental Entityshareholders agreement of such Person, or (iv) assessment of penalties under any Health Care Law, nor are any such advanced actions threatened or reasonably foreseeable. As of the date hereof, no Proceedings that would except for violations which could not reasonably be expected to result in any such material debarment, exclusion, prohibition, or assessment of penalties are pending or, to the Knowledge of the Company, threatened against the Company, its Subsidiaries, or any of their respective affiliates or their officers, employees, agents, or contractors.
(h) The Company and its Subsidiaries, and their respective affiliates have in place an operational regulatory compliance program that governs all employees, agents, and contractors and that is designed to address compliance with all applicable Health Care Laws. The Company and its Subsidiaries, and their respective affiliates operate in compliance with such regulatory compliance program in all material respects, except where noncompliance has not had and would not reasonably be expected to have a Company Material Adverse Effect.
(i) Since April 25, 202118.5. None of the Founder, the Company and each or any of its Subsidiariesthe Subsidiaries or VIE Affiliates or, and each of so far as they are aware, their current respective officers, directors, employees or Employees andagents, to the Knowledge of the Company, any agent is or other third party representative acting on behalf of the Company or any of its Subsidiaries (i) have at all times has been in material compliance with all Laws relating to export, reexport, transfer, and import control, economic and trade sanctions, and trade embargo statutes, regulations, decrees, orders, guidelines and policies of the United States government and the government of any country in which it conducts business including but not limited to the Export Administration Regulations (“EAR”) (15 C.F.R. Parts 730-774 (2022)) of the U.S. Department of Commerce; the U.S. antiboycott regulations and guidelines, including those under the EAR and U.S. Department of the Treasury regulations; the various economic sanctions regulations and guidelines of the U.S. Department of the Treasury, Office of Foreign Assets Control, and the USA Patriot Act (Title III of Pub. L. 107-56, signed into Law October 26, 2001), as amended; and restrictions against dealings with certain prohibited, debarred, denied or specially designated entities or individuals under statutes, regulations, orders, and decrees of various agencies of the United States government (collectively, “Trade Controls”); or (ii) have not engaged in any dealings or transactions with or for the benefit of any Sanctioned Person or in any Sanctioned Country.
(j) Neither the Company, nor any of its Subsidiaries, nor any of their respective officers, directors, Employees or, to the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries, has made, offered, promised or authorized any gift or payment of anything of value, directly or indirectly, to or for the benefit of any government official, or any other person, in order to assist the Company in obtaining or retaining business or otherwise securing any improper advantage in violation of applicable Anti-Corruption Laws.
(k) Neither the Company nor any of its Subsidiaries has received from any Governmental Entity or any Person any notice, inquiry, or internal or external allegation; made any voluntary or involuntary disclosure to a Governmental Entity; or conducted any internal investigation or audit concerning any actual or potential violation or wrongdoing in each case, related to Trade Controls or Anti-Corruption Laws.
(l) Since April 25, 2021 neither the Company nor its Subsidiaries or their respective affiliates or their employees, agents or contractors has entered into any arrangement involving the offering or paying any remuneration (including any kickback, bribe, discount or rebate), directly or indirectly, overtly or covertly in cash or in kind to any Person: (i) in return for referring an individual to the Company or any of its Subsidiaries for the furnishing or arranging for the furnishing violation of any item, product or services for which payment may be made in whole or in part by any Health Care Program or commercial health insurerapplicable laws and regulations on bribery and corruption and anti-money laundering; or (ii) in return for purchasingthe subject of OFAC sanctions, leasing or ordering or arranging for or recommending, purchasing, leasing or ordering any item, product, facility or service from or to the Company or any of its Subsidiaries for which payment may be made in whole or in part by any Health Care Program or commercial health insurer. There are no current arrangements relating to the Company or any of its Subsidiaries providing for any rebates, kickback or other forms of compensation that are unlawful to be paid (iii) party to any Person in return contract or arrangement (including for the referral or generation provision of business to financing) with another Person that is the Company or any subject of its Subsidiaries or for the arrangement for recommendation of such referrals or business. Since April 25, 2021, the Company enters into written agreements with each of its independent contractor health care providers and sales and marketing personnel in compliance with the AKS Personal Services and Management Contracts safe harbor (as set forth at 42 C.F.R. § 1001.952 (d))OFAC sanctions.
(m) The Company and its Subsidiaries and affiliates are and since April 25, 2021 have been in material compliance with all applicable Healthcare Privacy and Security Laws. Since April 25, 2021, no Breach (as that term is defined in HIPAA) has occurred with respect to any unsecured Protected Health Information (as that term is defined in HIPAA) (“PHI”) maintained by or for the Company, any of its Subsidiaries and affiliates. Since April 25, 2021, the Company, its Subsidiaries and affiliates have not received any notice or complaint from any Person, including any Governmental Entity regarding the unauthorized processing of PHI or non-compliance with applicable Healthcare Privacy and Security Laws. Neither the Company, nor its Subsidiaries and their respective affiliates engage in the sale of PHI, as the term “sale” is defined by applicable law.
Appears in 2 contracts
Samples: Series C Preferred Shares Purchase Agreement (YX Asset Recovery LTD), Series B Preferred Shares Purchase Agreement (YX Asset Recovery LTD)
Compliance with Laws and Orders. (a) The Company MAF and its Subsidiaries each MAF Subsidiary hold all licenses, franchises, permits and authorizations necessary for the lawful conduct of their respective businesses under and pursuant to each, and have complied in all respects with and are not in compliance default in any respect under any, applicable Law, and since April 25implementing rules, 2021 have been in compliance with all Laws (including all Health Care Laws) and Orders applicable regulations or publicly-issued statements of policy of any Governmental Authority relating to the Company MAF or any of its Subsidiaries or any assets owned or used by any of them (except for any such past noncompliance as has been remedied and imposes no continuing obligations or costs on the Company or its Subsidiaries)a MAF Subsidiary, except where any the failure to hold such non-compliancelicense, franchise, permit or authorization or such noncompliance or default is not reasonably likely to have, either individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect. Neither the Company nor any of its Subsidiaries has received any written communication since April 25, 2021, from any Governmental Entity that alleges that the Company or any of its Subsidiaries is not in compliance with any such Law or Order, except where any such non-compliance, individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect.
(b) Since April 25Except as disclosed in MAF Reports, 2021the businesses of MAF and each MAF Subsidiary are not being conducted in violation of any applicable Law or Governmental Order (including, there has without limitation, in the case of a MAF Subsidiary that is a thrift, all applicable Laws pertaining to the conduct of the banking business and the exercise of trust powers), except for violations which individually or in the aggregate do not been and currently there is no Proceeding pending against the Company or any of its Subsidiaries under any federal or state whistleblower statutehave, including under the False Claims Act, 31 U.S.C. §§ 3729-3733 and to the Knowledge of the CompanyMAF, no such Proceeding has been threatened. Neither the Company nor any of its Subsidiaries is a party to or has any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity with respect to any Health Care Law.
(c) Neither the Company nor any of its Subsidiaries has, since April 25, 2021, received or retained any payment in violation of applicable Health Care Laws or legally enforceable Health Care Program requirements (except for any such past violation as has been remedied and imposes no continuing obligations or costs on the Company or its Subsidiaries), except where any such violationwill not have, individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect.
(d) Since April 25, 2021, the Company and its Subsidiaries have not (i) had any product or manufacturing site (whether Company- or Subsidiary-owned) subject to a Governmental Entity (including the U.S. Food and Drug Administration (“FDA”)) shutdown or import or export prohibition, nor (ii) received any FDA Form 483 or other notice from a Governmental Entity of inspectional observations, notice of adverse finding, notice of violation, “warning letters,” “untitled letters” or requests or requirements to make changes to the products that if not complied with would reasonably be expected to have a Company Material Adverse Effect, and, to the Knowledge of the Company, no Governmental Entity has threatened any such action.
(e) The Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors have maintained and filed with the FDA and other Governmental Entities all material reports, data, documents, forms, notices, applications, records and claims that are necessary to comply in all material respects with applicable Health Care Laws. To the Knowledge of the CompanySeller, all such reports, data, documents, forms, notices, applications, records, claimsany MAF Subsidiary that is a bank or thrift is not in violation of those Laws applicable to depository institutions, and other filings corresponding regulations and publicly-issued statements of policy of any Governmental Authority relating to CRA, privacy Laws, the FDA and any similar BSA or anti-money laundering statutes in a manner that would materially delay the receipt of approvals of Governmental Entity by the Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors were true, accurate and complete in all material respects as of the date made, and, to the extent Authorities required to be updatedconsummate the transactions contemplated in this Agreement. Other than regulatory examinations conducted in the ordinary course, have been updated no investigation or review by any Governmental Authority with respect to be true, accurate and complete in all material respects as of the date of such update.
(f) None of the Company and its Subsidiaries, MAF or their respective affiliates or, to the Knowledge of the Company, their employees, agents, or contractors any MAF Subsidiary is the subject of any pending or, to the Knowledge of MAF, threatened, nor has any Governmental Authority indicated an intention to conduct the Company, threatened Proceeding same in respect each case other than those the outcome of the Company, its Subsidiaries, or any Company Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto.
(g) None of the Company and its Subsidiaries, or their respective affiliates or their officers, employees, agents, or contractors has been suspended, excluded, debarred, or convicted of any crime or engaged in any conduct that would which will not have nor reasonably be expected to result have, individually or in (i) debarment under 21 U.S.C. §§ 335(a)–(b) or any similar Lawthe aggregate, (ii) exclusion under 42 U.S.C. § 1320a-7 in any federal or state health care program or any similar Law, (iii) prohibition from participating in any procurement program of or otherwise contracting with any Governmental Entity, or (iv) assessment of penalties under any Health Care Law, nor are any such advanced actions threatened or reasonably foreseeable. As of the date hereof, no Proceedings that would reasonably be expected to result in any such material debarment, exclusion, prohibition, or assessment of penalties are pending or, to the Knowledge of the Company, threatened against the Company, its Subsidiaries, or any of their respective affiliates or their officers, employees, agents, or contractors.
(h) The Company and its Subsidiaries, and their respective affiliates have in place an operational regulatory compliance program that governs all employees, agents, and contractors and that is designed to address compliance with all applicable Health Care Laws. The Company and its Subsidiaries, and their respective affiliates operate in compliance with such regulatory compliance program in all material respects, except where noncompliance has not had and would not reasonably be expected to have a Company Material Adverse Effect.
(ic) Since April 25Except as is not reasonably likely to have, 2021either individually or in the aggregate, the Company a Material Adverse Effect, MAF and each of its SubsidiariesMAF Subsidiary have properly administered all accounts for which it acts as a fiduciary, and each of their respective officersincluding accounts for which it serves as a trustee, directorsagent, custodian, personal representative, guardian, conservator or Employees andinvestment advisor, to in accordance with the Knowledge terms of the Companygoverning documents, applicable Law and common law. None of MAF, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries (i) have at all times been in material compliance with all Laws relating to export, reexport, transfer, and import control, economic and trade sanctions, and trade embargo statutes, regulations, decrees, orders, guidelines and policies of the United States government and the government of any country in which it conducts business including but not limited to the Export Administration Regulations (“EAR”) (15 C.F.R. Parts 730-774 (2022)) of the U.S. Department of Commerce; the U.S. antiboycott regulations and guidelines, including those under the EAR and U.S. Department of the Treasury regulations; the various economic sanctions regulations and guidelines of the U.S. Department of the Treasury, Office of Foreign Assets Control, and the USA Patriot Act (Title III of Pub. L. 107-56, signed into Law October 26, 2001), as amended; and restrictions against dealings with certain prohibited, debarred, denied or specially designated entities or individuals under statutes, regulations, orders, and decrees of various agencies of the United States government (collectively, “Trade Controls”); or (ii) have not engaged in any dealings or transactions with or for the benefit of any Sanctioned Person or in any Sanctioned Country.
(j) Neither the Company, nor any of its Subsidiaries, nor any of their respective officers, directors, Employees or, to the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries, has made, offered, promised or authorized any gift or payment of anything of value, directly or indirectly, to or for the benefit of any government officialMAF Subsidiary, or any other persondirector, in order to assist the Company in obtaining officer or retaining business employee of MAF or otherwise securing any improper advantage in violation of applicable Anti-Corruption Laws.
(k) Neither the Company nor any of its Subsidiaries has received from any Governmental Entity or any Person any notice, inquiry, or internal or external allegation; made any voluntary or involuntary disclosure to a Governmental Entity; or conducted any internal investigation or audit concerning any actual or potential violation or wrongdoing in each case, related to Trade Controls or Anti-Corruption Laws.
(l) Since April 25, 2021 neither the Company nor its Subsidiaries or their respective affiliates or their employees, agents or contractors has entered into any arrangement involving the offering or paying any remuneration (including any kickback, bribe, discount or rebate), directly or indirectly, overtly or covertly in cash or in kind to any Person: (i) in return for referring an individual to the Company or any of its Subsidiaries for the furnishing or arranging for the furnishing of any itemMAF Subsidiary, product has committed any breach of trust or services for which payment may be made in whole or in part by any Health Care Program or commercial health insurer; or (ii) in return for purchasing, leasing or ordering or arranging for or recommending, purchasing, leasing or ordering any item, product, facility or service from or to the Company or any of its Subsidiaries for which payment may be made in whole or in part by any Health Care Program or commercial health insurer. There are no current arrangements relating to the Company or any of its Subsidiaries providing for any rebates, kickback or other forms of compensation that are unlawful to be paid to any Person in return for the referral or generation of business to the Company or any of its Subsidiaries or for the arrangement for recommendation of such referrals or business. Since April 25, 2021, the Company enters into written agreements with each of its independent contractor health care providers and sales and marketing personnel in compliance with the AKS Personal Services and Management Contracts safe harbor (as set forth at 42 C.F.R. § 1001.952 (d)).
(m) The Company and its Subsidiaries and affiliates are and since April 25, 2021 have been in material compliance with all applicable Healthcare Privacy and Security Laws. Since April 25, 2021, no Breach (as that term is defined in HIPAA) has occurred fiduciary duty with respect to any unsecured Protected Health Information (as such fiduciary account that term is defined in HIPAA) (“PHI”) maintained by reasonably likely to have, either individually or for the Company, any of its Subsidiaries and affiliates. Since April 25, 2021, the Company, its Subsidiaries and affiliates have not received any notice or complaint from any Person, including any Governmental Entity regarding the unauthorized processing of PHI or non-compliance with applicable Healthcare Privacy and Security Laws. Neither the Company, nor its Subsidiaries and their respective affiliates engage in the sale aggregate, a Material Adverse Effect, and the accountings for each such fiduciary account are true and correct and accurately reflect the assets of PHIsuch fiduciary account except as would not be reasonably likely to have, as either individually or in the term “sale” is defined by applicable lawaggregate, a Material Adverse Effect.
Appears in 2 contracts
Samples: Merger Agreement (National City Corp), Merger Agreement (Maf Bancorp Inc)
Compliance with Laws and Orders. (a) The Company and its Subsidiaries are in compliance and since April 25, 2021 have been in compliance with all Laws (including all Health Care Laws) and Orders applicable to the Company or any of its Subsidiaries or any assets owned or used by any of them (except for any such past noncompliance as has been remedied and imposes no continuing obligations or costs on the Company or its Subsidiaries), except where any such non-compliance, individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect. Neither the Company nor any of its Subsidiaries has received any written communication since April 25, 2021, from any Governmental Entity that alleges that the Company or any of its Subsidiaries is not in compliance with any such Law or Order, except where any such non-compliance, individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect.
(b) Since April 25, 2021, there has not been and currently there is no Proceeding pending against the Company or any of its Subsidiaries under any federal or state whistleblower statute, including under the False Claims Act, 31 U.S.C. §§ 3729-3733 and to the Knowledge of the Company, no such Proceeding has been threatened. Neither the Company nor any of its Subsidiaries is a party to in violation of or has any ongoing reporting obligations pursuant to or in default under any corporate integrity agreementsLaw or Order, deferred the effect of which, individually or non-prosecution agreementsin the aggregate with other such violations and defaults, monitoring agreementswould reasonably be expected to have a Material Adverse Effect on the Company; provided, consent decreeshowever, settlement ordersthat the Sellers make no representation or warranty in this Section 2.06 with respect to ERISA and employment benefit laws, environmental matters or similar agreements Tax Laws which are specifically and exclusively addressed in Sections 2.10, 2.12 and 2.13 hereof, respectively. Each Seller has complied in all material respects with all applicable Laws and Orders applicable to the Chapter 11 Cases.
(b) Except as would not, individually or imposed in the aggregate with other violations and defaults, reasonably be expected to have a Material Adverse Effect on the Company, no investigation or review by any Governmental Entity with respect to Authority concerning any Health Care Lawpossible violation or default of Law or Order is pending or threatened, nor has any such investigation occurred during the last five years.
(ci) Neither the The Company nor any of and its Subsidiaries hashold all material licenses, since April 25permits, 2021registrations and other authorizations required to conduct the Business as it is presently conducted, received or retained any payment (ii) all such licenses, permits, registrations and other authorizations are valid and in violation of applicable Health Care Laws or legally enforceable Health Care Program requirements (full force and effect, except for any such past violation as has been remedied and imposes no continuing obligations or costs on those the Company or its Subsidiaries), except where any such violationabsence of which, individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect.
(d) Since April 25, 2021, the Company and its Subsidiaries have not (i) had any product or manufacturing site (whether Company- or Subsidiary-owned) subject to a Governmental Entity (including the U.S. Food and Drug Administration (“FDA”)) shutdown or import or export prohibition, nor (ii) received any FDA Form 483 or other notice from a Governmental Entity of inspectional observations, notice of adverse finding, notice of violation, “warning letters,” “untitled letters” or requests or requirements to make changes to the products that if not complied with would reasonably be expected to have a Company Material Adverse Effect, and, to the Knowledge of the Company, no Governmental Entity has threatened any such action.
(e) The Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors have maintained and filed with the FDA and other Governmental Entities all material reports, data, documents, forms, notices, applications, records and claims that are necessary to comply in all material respects with applicable Health Care Laws. To the Knowledge of the Company, all such reports, data, documents, forms, notices, applications, records, claims, and other filings to the FDA and any similar Governmental Entity by the Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, have been updated to be true, accurate and complete in all material respects as of the date of such update.
(f) None of the Company and its Subsidiaries, or their respective affiliates or, to the Knowledge of the Company, their employees, agents, or contractors is the subject of any pending or, to the Knowledge of the Company, threatened Proceeding in respect of the Company, its Subsidiaries, or any Company Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto.
(g) None of the Company and its Subsidiaries, or their respective affiliates or their officers, employees, agents, or contractors has been suspended, excluded, debarred, or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. §§ 335(a)–(b) or any similar Law, (ii) exclusion under 42 U.S.C. § 1320a-7 in any federal or state health care program or any similar Law, (iii) prohibition from participating in any procurement program of or otherwise contracting with any Governmental Entity, or (iv) assessment of penalties under any Health Care Law, nor are any such advanced actions threatened or reasonably foreseeable. As of the date hereof, no Proceedings that would reasonably be expected to result in any such material debarment, exclusion, prohibition, or assessment of penalties are pending or, to the Knowledge of the Company, threatened against the Company, its Subsidiaries, or any of their respective affiliates or their officers, employees, agents, or contractors.
(h) The Company and its Subsidiaries, and their respective affiliates have in place an operational regulatory compliance program that governs all employees, agents, and contractors and that is designed to address compliance with all applicable Health Care Laws. The Company and its Subsidiaries, and their respective affiliates operate in compliance with such regulatory compliance program in all material respects, except where noncompliance has not had and would not reasonably be expected to have a Company Material Adverse Effect.
Effect on the Company, (iiii) Since April 25, 2021, the Company and each of its SubsidiariesSubsidiary are in compliance with all such licenses, permits, registrations and each of their respective officersother authorizations, directorsexcept for possible failures to be so in compliance which would not, individually or Employees andin the aggregate, reasonably be expected to the Knowledge of have a Material Adverse Effect on the Company, and (iv) subject to approval of the Bankruptcy Court, the execution and delivery by the Company of this Agreement and the performance by the Company of its pre-Closing obligations hereunder will not, and, upon entry of the Sale Order, the consummation of the transactions contemplated hereby, including the performance by any agent Subsidiary of the Company of transfers, assumptions or other third party representative acting on behalf actions required of it by this Agreement to effect such consummation will not, result in a violation or breach of, or cause the Company or any of its Subsidiaries (i) have at all times been to fail to be in material compliance with all Laws relating with, any such licenses, permits, registrations and other authorizations, except for such violations, breaches or failures to exportbe so in compliance which, reexport, transfer, and import control, economic and trade sanctions, and trade embargo statutes, regulations, decrees, orders, guidelines and policies of the United States government and the government of any country in which it conducts business including but not limited to the Export Administration Regulations (“EAR”) (15 C.F.R. Parts 730-774 (2022)) of the U.S. Department of Commerce; the U.S. antiboycott regulations and guidelines, including those under the EAR and U.S. Department of the Treasury regulations; the various economic sanctions regulations and guidelines of the U.S. Department of the Treasury, Office of Foreign Assets Control, and the USA Patriot Act (Title III of Pub. L. 107-56, signed into Law October 26, 2001), as amended; and restrictions against dealings with certain prohibited, debarred, denied or specially designated entities or individuals under statutes, regulations, orders, and decrees of various agencies of the United States government (collectively, “Trade Controls”); or (ii) have not engaged in any dealings or transactions with or for the benefit of any Sanctioned Person individually or in any Sanctioned Country.
(j) Neither the aggregate, would not reasonably be expected to have a Material Adverse Effect on the Company, nor any of its Subsidiaries, nor any of their respective officers, directors, Employees or, to the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries, has made, offered, promised or authorized any gift or payment of anything of value, directly or indirectly, to or for the benefit of any government official, or any other person, in order to assist the Company in obtaining or retaining business or otherwise securing any improper advantage in violation of applicable Anti-Corruption Laws.
(k) Neither the Company nor any of its Subsidiaries has received from any Governmental Entity or any Person any notice, inquiry, or internal or external allegation; made any voluntary or involuntary disclosure to a Governmental Entity; or conducted any internal investigation or audit concerning any actual or potential violation or wrongdoing in each case, related to Trade Controls or Anti-Corruption Laws.
(l) Since April 25, 2021 neither the Company nor its Subsidiaries or their respective affiliates or their employees, agents or contractors has entered into any arrangement involving the offering or paying any remuneration (including any kickback, bribe, discount or rebate), directly or indirectly, overtly or covertly in cash or in kind to any Person: (i) in return for referring an individual to the Company or any of its Subsidiaries for the furnishing or arranging for the furnishing of any item, product or services for which payment may be made in whole or in part by any Health Care Program or commercial health insurer; or (ii) in return for purchasing, leasing or ordering or arranging for or recommending, purchasing, leasing or ordering any item, product, facility or service from or to the Company or any of its Subsidiaries for which payment may be made in whole or in part by any Health Care Program or commercial health insurer. There are no current arrangements relating to the Company or any of its Subsidiaries providing for any rebates, kickback or other forms of compensation that are unlawful to be paid to any Person in return for the referral or generation of business to the Company or any of its Subsidiaries or for the arrangement for recommendation of such referrals or business. Since April 25, 2021, the Company enters into written agreements with each of its independent contractor health care providers and sales and marketing personnel in compliance with the AKS Personal Services and Management Contracts safe harbor (as set forth at 42 C.F.R. § 1001.952 (d)).
(m) The Company and its Subsidiaries and affiliates are and since April 25, 2021 have been in material compliance with all applicable Healthcare Privacy and Security Laws. Since April 25, 2021, no Breach (as that term is defined in HIPAA) has occurred with respect to any unsecured Protected Health Information (as that term is defined in HIPAA) (“PHI”) maintained by or for the Company, any of its Subsidiaries and affiliates. Since April 25, 2021, the Company, its Subsidiaries and affiliates have not received any notice or complaint from any Person, including any Governmental Entity regarding the unauthorized processing of PHI or non-compliance with applicable Healthcare Privacy and Security Laws. Neither the Company, nor its Subsidiaries and their respective affiliates engage in the sale of PHI, as the term “sale” is defined by applicable law.
Appears in 1 contract
Compliance with Laws and Orders. (a) The Company and its Subsidiaries are Except as disclosed in compliance and since April 25Schedule 2.08, 2021 have been to the Knowledge of Sellers:
(i) neither Seller is in compliance with all Laws (including all Health Care Laws) and Orders violation of or default, in any material respect, under any Law or Order applicable to the Company Business or the Assets;
(ii) Sellers have not taken any action which would reasonably be likely to (A) constitute or result in a violation by any Seller of or a failure on the part of any Seller to comply with, in each case in any material respect, any Law or Order applicable to the Business or any material term or requirement of its Subsidiaries any License listed or required to be listed in Schedule 2.08, (B) result in the revocation, withdrawal, suspension, cancellation or termination of, or any assets owned material modification to, any License listed or used by required to be listed in Schedule 2.08, or (C) give rise to any of them (except for any such past noncompliance as has been remedied and imposes no continuing obligations or costs obligation on the Company part of any Seller to undertake, or its Subsidiaries)to bear all or any portion of the cost of, except where any such non-compliance, individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect. Neither the Company nor material remedial action of any of its Subsidiaries nature;
(iii) neither Seller has received any notice in writing or other written communication since April 25, 2021, from any Governmental Entity that alleges that the Company or Regulatory Authority or any of its Subsidiaries is not in compliance with other Person regarding (A) any such actual or alleged violation of, or failure to comply with, any material Law or OrderOrder or any term or requirement of any License listed or required to be listed in Schedule 2.08, except where (B) any such non-complianceactual or proposed revocation, individually withdrawal, suspension, cancellation or termination of, any License listed or required to be listed in Schedule 2.08 or (C) any actual or alleged obligation on the aggregatepart of any Seller to undertake, or to bear all or any portion of the cost of, any material remedial action that has not hadbeen fully complied with or corrected;
(iv) all applications required to have been filed for the renewal of the Licenses listed in Section 2.08 have been duly filed on a timely basis with the appropriate Governmental or Regulatory Authority, and would not reasonably be expected all other filings required to have, have been made with respect to such Licenses have been duly made on a Company Material Adverse Effecttimely basis with the appropriate Governmental or Regulatory Authority.
(b) Since April 25, 2021, there has not been and currently there is no Proceeding pending against the Company or any of its Subsidiaries under any federal or state whistleblower statute, including under the False Claims Act, 31 U.S.C. §§ 3729-3733 and to the Knowledge The Licenses listed in Schedule 2.08 collectively constitute all of the Company, no such Proceeding has been threatened. Neither the Company nor any of its Subsidiaries is a party to or has any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity with respect to any Health Care Law.
(c) Neither the Company nor any of its Subsidiaries has, since April 25, 2021, received or retained any payment in violation of applicable Health Care Laws or legally enforceable Health Care Program requirements (except for any such past violation as has been remedied and imposes no continuing obligations or costs on the Company or its Subsidiaries), except where any such violation, individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect.
(d) Since April 25, 2021, the Company and its Subsidiaries have not (i) had any product or manufacturing site (whether Company- or Subsidiary-owned) subject to a Governmental Entity (including the U.S. Food and Drug Administration (“FDA”)) shutdown or import or export prohibition, nor (ii) received any FDA Form 483 or other notice from a Governmental Entity of inspectional observations, notice of adverse finding, notice of violation, “warning letters,” “untitled letters” or requests or requirements to make changes to the products that if not complied with would reasonably be expected to have a Company Material Adverse Effect, and, to the Knowledge of the Company, no Governmental Entity has threatened any such action.
(e) The Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors have maintained and filed with the FDA and other Governmental Entities all material reports, data, documents, forms, notices, applications, records and claims that are Licenses necessary to comply permit Sellers to lawfully conduct and operate the Business in all material respects with applicable Health Care Laws. To in the Knowledge of the Company, all such reports, data, documents, forms, notices, applications, records, claims, and other filings to the FDA and any similar Governmental Entity by the Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, have been updated to be true, accurate and complete in all material respects as of the date of such update.
(f) None of the Company and its Subsidiaries, or their respective affiliates or, to the Knowledge of the Company, their employees, agents, or contractors is the subject of any pending or, to the Knowledge of the Company, threatened Proceeding in respect of the Company, its Subsidiaries, or any Company Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto.
(g) None of the Company and its Subsidiaries, or their respective affiliates or their officers, employees, agents, or contractors has been suspended, excluded, debarred, or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. §§ 335(a)–(b) or any similar Law, (ii) exclusion under 42 U.S.C. § 1320a-7 in any federal or state health care program or any similar Law, (iii) prohibition from participating in any procurement program of or otherwise contracting with any Governmental Entity, or (iv) assessment of penalties under any Health Care Law, nor are any such advanced actions threatened or reasonably foreseeable. As of the date hereof, no Proceedings that would reasonably be expected to result in any such material debarment, exclusion, prohibition, or assessment of penalties are pending or, to the Knowledge of the Company, threatened against the Company, its Subsidiaries, or any of their respective affiliates or their officers, employees, agents, or contractors.
(h) The Company and its Subsidiaries, and their respective affiliates have in place an operational regulatory compliance program that governs all employees, agents, and contractors and that is designed to address compliance with all applicable Health Care Laws. The Company and its Subsidiaries, and their respective affiliates operate in compliance with such regulatory compliance program in all material respects, except where noncompliance has not had and would not reasonably be expected to have a Company Material Adverse Effect.
(i) Since April 25, 2021, the Company and each of its Subsidiaries, and each of their respective officers, directors, or Employees and, to the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries (i) have at all times been in material compliance with all Laws relating to export, reexport, transfer, and import control, economic and trade sanctions, and trade embargo statutes, regulations, decrees, orders, guidelines and policies of the United States government and the government of any country manner in which it conducts business including but not limited Sellers currently conduct and operate such Business and to the Export Administration Regulations (“EAR”) (15 C.F.R. Parts 730-774 (2022)) of the U.S. Department of Commerce; the U.S. antiboycott regulations permit Sellers to own and guidelines, including those under the EAR use their Assets and U.S. Department of the Treasury regulations; the various economic sanctions regulations and guidelines of the U.S. Department of the Treasury, Office of Foreign Assets Control, and the USA Patriot Act (Title III of Pub. L. 107-56, signed into Law October 26, 2001), as amended; and restrictions against dealings with certain prohibited, debarred, denied or specially designated entities or individuals under statutes, regulations, orders, and decrees of various agencies of the United States government (collectively, “Trade Controls”); or (ii) have not engaged in any dealings or transactions with or for the benefit of any Sanctioned Person or in any Sanctioned Country.
(j) Neither the Company, nor any of its Subsidiaries, nor any of their respective officers, directors, Employees or, to the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries, has made, offered, promised or authorized any gift or payment of anything of value, directly or indirectly, to or for the benefit of any government official, or any other person, in order to assist the Company in obtaining or retaining business or otherwise securing any improper advantage in violation of applicable Anti-Corruption Laws.
(k) Neither the Company nor any of its Subsidiaries has received from any Governmental Entity or any Person any notice, inquiry, or internal or external allegation; made any voluntary or involuntary disclosure to a Governmental Entity; or conducted any internal investigation or audit concerning any actual or potential violation or wrongdoing in each case, related to Trade Controls or Anti-Corruption Laws.
(l) Since April 25, 2021 neither the Company nor its Subsidiaries or their respective affiliates or their employees, agents or contractors has entered into any arrangement involving the offering or paying any remuneration (including any kickback, bribe, discount or rebate), directly or indirectly, overtly or covertly in cash or in kind to any Person: (i) in return for referring an individual to the Company or any of its Subsidiaries for the furnishing or arranging for the furnishing of any item, product or services for which payment may be made in whole or in part by any Health Care Program or commercial health insurer; or (ii) in return for purchasing, leasing or ordering or arranging for or recommending, purchasing, leasing or ordering any item, product, facility or service from or to the Company or any of its Subsidiaries for which payment may be made in whole or in part by any Health Care Program or commercial health insurer. There are no current arrangements relating to the Company or any of its Subsidiaries providing for any rebates, kickback or other forms of compensation that are unlawful to be paid to any Person in return for the referral or generation of business to the Company or any of its Subsidiaries or for the arrangement for recommendation of such referrals or business. Since April 25, 2021, the Company enters into written agreements with each of its independent contractor health care providers and sales and marketing personnel in compliance with the AKS Personal Services and Management Contracts safe harbor (as set forth at 42 C.F.R. § 1001.952 (d)).
(m) The Company and its Subsidiaries and affiliates are and since April 25, 2021 have been in material compliance with all applicable Healthcare Privacy and Security Laws. Since April 25, 2021, no Breach (as that term is defined in HIPAA) has occurred with respect to any unsecured Protected Health Information (as that term is defined in HIPAA) (“PHI”) maintained by or for the Company, any of its Subsidiaries and affiliates. Since April 25, 2021, the Company, its Subsidiaries and affiliates have not received any notice or complaint from any Person, including any Governmental Entity regarding the unauthorized processing of PHI or non-compliance with applicable Healthcare Privacy and Security Laws. Neither the Company, nor its Subsidiaries and their respective affiliates engage Properties in the sale of PHI, as the term “sale” is defined by applicable lawmanner in which they currently own and use such Assets and Properties.
Appears in 1 contract
Compliance with Laws and Orders. (a) The Company National City and its Subsidiaries each National City Subsidiary hold all licenses, franchises, permits and authorizations necessary for the lawful conduct of their respective businesses under and pursuant to each, and have complied in all respects with and are not in compliance and since April 25default in any respect under any, 2021 have been in compliance with all Laws (including all Health Care Laws) and Orders applicable law, statute, order, rule, regulation, policy or guideline of any Governmental Entity relating to the Company National City or any of its Subsidiaries or any assets owned or used by any of them (except for any such past noncompliance as has been remedied and imposes no continuing obligations or costs on the Company or its Subsidiaries)National City Subsidiary, except where any the failure to hold such non-compliancelicense, franchise, permit or authorization or such noncompliance or default is not reasonably likely to have, either individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect. Neither the Company nor any of its Subsidiaries has received any written communication since April 25, 2021, from any Governmental Entity that alleges that the Company or any of its Subsidiaries is not in compliance with any such Law or Order, except where any such non-compliance, individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect.
(b) Since April 25, 2021, there has not been and currently there is no Proceeding pending against Except as set forth in the Company National City Disclosure Letter or any of its Subsidiaries under any federal or state whistleblower statute, including under disclosed in the False Claims Act, 31 U.S.C. §§ 3729-3733 and National City Reports filed by National City with the Commission prior to the Knowledge date of this Agreement, the businesses of National City and of National City's Subsidiaries are not being conducted in violation of any law, ordinance, regulation, judgment, order, decree, license or permit of any Governmental Entity (including, without limitation, in the case of National City's Subsidiaries that are banks, all statutes, rules and regulations pertaining to the conduct of the Companybanking business and the exercise of trust powers), except for violations which individually or in the aggregate do not, and, insofar as reasonably can be foreseen, in the future will not, have a Material Adverse Effect. Except as set forth in the National City Disclosure Letter, no such Proceeding has been threatened. Neither the Company nor any of its Subsidiaries is a party to investigation or has any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed review by any Governmental Entity with respect to National City or any Health Care Lawof National City's Subsidiaries is pending or, to the knowledge of National City, threatened, nor has any Governmental Entity indicated an intention to conduct the same in each case other than those the outcome of which will not have a Material Adverse Effect.
(c) Neither the Company nor any of its Subsidiaries hasExcept as is not reasonably likely to have, since April 25, 2021, received or retained any payment in violation of applicable Health Care Laws or legally enforceable Health Care Program requirements (except for any such past violation as has been remedied and imposes no continuing obligations or costs on the Company or its Subsidiaries), except where any such violation, either individually or in the aggregate, a Material Adverse Effect, National City and each National City Subsidiary have properly administered all accounts for which its acts as a fiduciary, including accounts for which it serves as a trustee, agent, custodian, personal representative, guardian, conservator or investment advisor, in accordance with the terms of the governing documents, applicable state and federal law and regulation and common law. None of National City, any National City Subsidiary, or any director, officer or employee of National City or of any National City Subsidiary, has not had, and would not committed any breach of trust or fiduciary duty with respect to any such fiduciary account that is reasonably be expected likely to have, either individually or in the aggregate, a Company Material Adverse Effect.
(d) Since April 25, 2021, the Company and its Subsidiaries have not (i) had any product or manufacturing site (whether Company- or Subsidiary-owned) subject to a Governmental Entity (including the U.S. Food and Drug Administration (“FDA”)) shutdown or import or export prohibition, nor (ii) received any FDA Form 483 or other notice from a Governmental Entity of inspectional observations, notice of adverse finding, notice of violation, “warning letters,” “untitled letters” or requests or requirements to make changes to the products that if not complied with would reasonably be expected to have a Company Material Adverse Effect, and, to the Knowledge of the Company, no Governmental Entity has threatened any such action.
(e) The Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors have maintained and filed with the FDA and other Governmental Entities all material reports, data, documents, forms, notices, applications, records and claims that are necessary to comply in all material respects with applicable Health Care Laws. To the Knowledge of the Company, all such reports, data, documents, forms, notices, applications, records, claims, and other filings to the FDA and any similar Governmental Entity by the Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors were true, accurate and complete in all material respects except as of the date made, and, to the extent required to be updated, have been updated to be true, accurate and complete in all material respects as of the date of such update.
(f) None of the Company and its Subsidiaries, or their respective affiliates or, to the Knowledge of the Company, their employees, agents, or contractors is the subject of any pending or, to the Knowledge of the Company, threatened Proceeding in respect of the Company, its Subsidiaries, or any Company Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto.
(g) None of the Company and its Subsidiaries, or their respective affiliates or their officers, employees, agents, or contractors has been suspended, excluded, debarred, or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. §§ 335(a)–(b) or any similar Law, (ii) exclusion under 42 U.S.C. § 1320a-7 in any federal or state health care program or any similar Law, (iii) prohibition from participating in any procurement program of or otherwise contracting with any Governmental Entity, or (iv) assessment of penalties under any Health Care Law, nor are any such advanced actions threatened or reasonably foreseeable. As of the date hereof, no Proceedings that would reasonably be expected to result in any such material debarment, exclusion, prohibition, or assessment of penalties are pending or, to the Knowledge of the Company, threatened against the Company, its Subsidiaries, or any of their respective affiliates or their officers, employees, agents, or contractors.
(h) The Company and its Subsidiaries, and their respective affiliates have in place an operational regulatory compliance program that governs all employees, agents, and contractors and that is designed to address compliance with all applicable Health Care Laws. The Company and its Subsidiaries, and their respective affiliates operate in compliance with such regulatory compliance program in all material respects, except where noncompliance has not had and would not be reasonably be expected likely to have have, either individually or in the aggregate, a Company Material Adverse Effect.
(i) Since April 25, 2021, the Company and each of its Subsidiaries, and each of their respective officers, directors, or Employees and, to the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries (i) have at all times been in material compliance with all Laws relating to export, reexport, transfer, and import control, economic and trade sanctions, and trade embargo statutes, regulations, decrees, orders, guidelines and policies of the United States government and the government of any country in which it conducts business including but not limited to the Export Administration Regulations (“EAR”) (15 C.F.R. Parts 730-774 (2022)) of the U.S. Department of Commerce; the U.S. antiboycott regulations and guidelines, including those under the EAR and U.S. Department of the Treasury regulations; the various economic sanctions regulations and guidelines of the U.S. Department of the Treasury, Office of Foreign Assets Control, and the USA Patriot Act (Title III of Pub. L. 107-56, signed into Law October 26, 2001), as amended; accountings for each such fiduciary account are true and restrictions against dealings with certain prohibited, debarred, denied or specially designated entities or individuals under statutes, regulations, orders, correct and decrees of various agencies of accurately reflect the United States government (collectively, “Trade Controls”); or (ii) have not engaged in any dealings or transactions with or for the benefit of any Sanctioned Person or in any Sanctioned Country.
(j) Neither the Company, nor any of its Subsidiaries, nor any of their respective officers, directors, Employees or, to the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries, has made, offered, promised or authorized any gift or payment of anything of value, directly or indirectly, to or for the benefit of any government official, or any other person, in order to assist the Company in obtaining or retaining business or otherwise securing any improper advantage in violation of applicable Anti-Corruption Laws.
(k) Neither the Company nor any of its Subsidiaries has received from any Governmental Entity or any Person any notice, inquiry, or internal or external allegation; made any voluntary or involuntary disclosure to a Governmental Entity; or conducted any internal investigation or audit concerning any actual or potential violation or wrongdoing in each case, related to Trade Controls or Anti-Corruption Laws.
(l) Since April 25, 2021 neither the Company nor its Subsidiaries or their respective affiliates or their employees, agents or contractors has entered into any arrangement involving the offering or paying any remuneration (including any kickback, bribe, discount or rebate), directly or indirectly, overtly or covertly in cash or in kind to any Person: (i) in return for referring an individual to the Company or any of its Subsidiaries for the furnishing or arranging for the furnishing of any item, product or services for which payment may be made in whole or in part by any Health Care Program or commercial health insurer; or (ii) in return for purchasing, leasing or ordering or arranging for or recommending, purchasing, leasing or ordering any item, product, facility or service from or to the Company or any of its Subsidiaries for which payment may be made in whole or in part by any Health Care Program or commercial health insurer. There are no current arrangements relating to the Company or any of its Subsidiaries providing for any rebates, kickback or other forms of compensation that are unlawful to be paid to any Person in return for the referral or generation of business to the Company or any of its Subsidiaries or for the arrangement for recommendation assets of such referrals or business. Since April 25, 2021, the Company enters into written agreements with each of its independent contractor health care providers and sales and marketing personnel in compliance with the AKS Personal Services and Management Contracts safe harbor (as set forth at 42 C.F.R. § 1001.952 (d))fiduciary account.
(m) The Company and its Subsidiaries and affiliates are and since April 25, 2021 have been in material compliance with all applicable Healthcare Privacy and Security Laws. Since April 25, 2021, no Breach (as that term is defined in HIPAA) has occurred with respect to any unsecured Protected Health Information (as that term is defined in HIPAA) (“PHI”) maintained by or for the Company, any of its Subsidiaries and affiliates. Since April 25, 2021, the Company, its Subsidiaries and affiliates have not received any notice or complaint from any Person, including any Governmental Entity regarding the unauthorized processing of PHI or non-compliance with applicable Healthcare Privacy and Security Laws. Neither the Company, nor its Subsidiaries and their respective affiliates engage in the sale of PHI, as the term “sale” is defined by applicable law.
Appears in 1 contract
Compliance with Laws and Orders. (a) The Company and its Subsidiaries are in compliance hold all permits, licenses, variances, exemptions, orders and since April 25, 2021 have been in compliance with approvals (other than FCC Licenses) of all Laws Governmental and Regulatory Authorities necessary for the lawful conduct of their respective businesses (including all Health Care Laws) and Orders applicable to the "Company or any of its Subsidiaries or any assets owned or used by any of them (except for any such past noncompliance as has been remedied and imposes no continuing obligations or costs on the Company or its SubsidiariesPermits"), except where any for failures to hold such non-compliancepermits, licenses, variances, exemptions, orders and approvals which, individually or in the aggregate, has are not had, having and would could not be reasonably be expected to have, a Company Material Adverse Effect. Neither the Company nor any of its Subsidiaries has received any written communication since April 25, 2021, from any Governmental Entity that alleges that the Company or any of its Subsidiaries is not in compliance with any such Law or Order, except where any such non-compliance, individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect.
(b) Since April 25, 2021, there has not been and currently there is no Proceeding pending against the Company or any of its Subsidiaries under any federal or state whistleblower statute, including under the False Claims Act, 31 U.S.C. §§ 3729-3733 and to the Knowledge of the Company, no such Proceeding has been threatened. Neither the Company nor any of its Subsidiaries is a party to or has any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity with respect to any Health Care Law.
(c) Neither the Company nor any of its Subsidiaries has, since April 25, 2021, received or retained any payment in violation of applicable Health Care Laws or legally enforceable Health Care Program requirements (except for any such past violation as has been remedied and imposes no continuing obligations or costs on the Company or its Subsidiaries), except where any such violation, individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect.
(d) Since April 25, 2021, the Company and its Subsidiaries have not (i) had any product or manufacturing site (whether Company- or Subsidiary-owned) subject to a Governmental Entity (including the U.S. Food and Drug Administration (“FDA”)) shutdown or import or export prohibition, nor (ii) received any FDA Form 483 or other notice from a Governmental Entity of inspectional observations, notice of adverse finding, notice of violation, “warning letters,” “untitled letters” or requests or requirements to make changes to the products that if not complied with would reasonably be expected to have a Company Material Adverse Effect, and, to the Knowledge of the Company, no Governmental Entity has threatened any such action.
(e) The Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors have maintained and filed with the FDA and other Governmental Entities all material reports, data, documents, forms, notices, applications, records and claims that are necessary to comply in all material respects with applicable Health Care Laws. To the Knowledge of the Company, all such reports, data, documents, forms, notices, applications, records, claims, and other filings to the FDA and any similar Governmental Entity by the Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, have been updated to be true, accurate and complete in all material respects as of the date of such update.
(f) None of the Company and its Subsidiaries, or their respective affiliates or, to the Knowledge of the Company, their employees, agents, or contractors is the subject of any pending or, to the Knowledge of the Company, threatened Proceeding in respect of the Company, its Subsidiaries, or any Company Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto.
(g) None of the Company and its Subsidiaries, or their respective affiliates or their officers, employees, agents, or contractors has been suspended, excluded, debarred, or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. §§ 335(a)–(b) or any similar Law, (ii) exclusion under 42 U.S.C. § 1320a-7 in any federal or state health care program or any similar Law, (iii) prohibition from participating in any procurement program of or otherwise contracting with any Governmental Entity, or (iv) assessment of penalties under any Health Care Law, nor are any such advanced actions threatened or reasonably foreseeable. As of the date hereof, no Proceedings that would reasonably be expected to result in any such material debarment, exclusion, prohibition, or assessment of penalties are pending or, to the Knowledge of the Company, threatened against the Company, its Subsidiaries, or any of their respective affiliates or their officers, employees, agents, or contractors.
(h) The Company and its Subsidiaries, and their respective affiliates have in place an operational regulatory compliance program that governs all employees, agents, and contractors and that is designed to address compliance with all applicable Health Care Laws. The Company and its Subsidiaries, and their respective affiliates operate Subsidiaries are in compliance with such regulatory compliance program in all material respectsthe terms of the Company Permits, except where noncompliance has failures so to comply which, individually or in the aggregate, are not had having and would could not be reasonably expected to have a Company Material Adverse Effect. The Company and its Subsidiaries are not in violation of any Law or Order of any Governmental or Regulatory Authority, except for violations which, individually or in the aggregate, are not having and could not be reasonably expected to have a Company Material Adverse Effect.
(b) Except as does not materially jeopardize the operation by the Company or applicable Subsidiary of the Company of any of the Company Stations to which FCC Licenses apply:
(i) Since April 25, 2021, the Company and each those of its Subsidiaries, and each of their respective officers, directorsSubsidiaries that are required to hold FCC Licenses, or Employees andthat control FCC Licenses, to the Knowledge knowledge of the Company, any agent are qualified to hold such FCC Licenses or other third party representative acting on behalf of to control such FCC Licenses, as the case may be; (ii) the Company or any and those of its Subsidiaries that are required to hold FCC Licenses hold such FCC Licenses; (iiii) have at all times been except as provided in material compliance Section 8.06 with all Laws relating respect to exportthe divestiture of certain assets described therein, reexport, transfer, and import control, economic and trade sanctions, and trade embargo statutes, regulations, decrees, orders, guidelines and policies of the United States government and the government Company is not aware of any country in which it conducts business including but not limited to the Export Administration Regulations (“EAR”) (15 C.F.R. Parts 730-774 (2022)) of the U.S. Department of Commerce; the U.S. antiboycott regulations and guidelines, including those under the EAR and U.S. Department of the Treasury regulations; the various economic sanctions regulations and guidelines of the U.S. Department of the Treasury, Office of Foreign Assets Control, and the USA Patriot Act (Title III of Pub. L. 107-56, signed into Law October 26, 2001), as amended; and restrictions against dealings with certain prohibited, debarred, denied facts or specially designated entities or individuals under statutes, regulations, orders, and decrees of various agencies of the United States government (collectively, “Trade Controls”); or (ii) have not engaged in any dealings or transactions with or for the benefit of any Sanctioned Person or in any Sanctioned Country.
(j) Neither the Company, nor any of its Subsidiaries, nor any of their respective officers, directors, Employees or, to the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries, has made, offered, promised or authorized any gift or payment of anything of value, directly or indirectly, to or for the benefit of any government official, or any other person, in order to assist the Company in obtaining or retaining business or otherwise securing any improper advantage in violation of applicable Anti-Corruption Laws.
(k) Neither the Company nor any of its Subsidiaries has received from any Governmental Entity or any Person any notice, inquiry, or internal or external allegation; made any voluntary or involuntary disclosure to a Governmental Entity; or conducted any internal investigation or audit concerning any actual or potential violation or wrongdoing in each case, related to Trade Controls or Anti-Corruption Laws.
(l) Since April 25, 2021 neither the Company nor its Subsidiaries or their respective affiliates or their employees, agents or contractors has entered into any arrangement involving the offering or paying any remuneration (including any kickback, bribe, discount or rebate), directly or indirectly, overtly or covertly in cash or in kind to any Person: (i) in return for referring an individual to the Company or any of its Subsidiaries for the furnishing or arranging for the furnishing of any item, product or services for which payment may be made in whole or in part by any Health Care Program or commercial health insurer; or (ii) in return for purchasing, leasing or ordering or arranging for or recommending, purchasing, leasing or ordering any item, product, facility or service from or to the Company or any of its Subsidiaries for which payment may be made in whole or in part by any Health Care Program or commercial health insurer. There are no current arrangements circumstances relating to the Company or any of its Subsidiaries providing for any rebates, kickback or other forms that would prevent the granting of compensation that are unlawful to be paid to any Person in return for the referral or generation of business to the FCC Approval; (iv) each Company or any of its Subsidiaries or for the arrangement for recommendation of such referrals or business. Since April 25, 2021, the Company enters into written agreements with each of its independent contractor health care providers and sales and marketing personnel in compliance with the AKS Personal Services and Management Contracts safe harbor (as set forth at 42 C.F.R. § 1001.952 (d)).
(m) The Company and its Subsidiaries and affiliates are and since April 25, 2021 have been Station is in material compliance with all applicable Healthcare Privacy FCC Licenses held by it; and Security Laws. Since April 25(v) there is not pending or, 2021, no Breach (as that term is defined in HIPAA) has occurred with respect to any unsecured Protected Health Information (as that term is defined in HIPAA) (“PHI”) maintained by or for the knowledge of the Company, threatened any application, petition, objection or other pleading with the FCC or other Governmental or Regulatory Authority which challenges the validity of, or any rights of the holder under, any FCC License held by the Company or one of its Subsidiaries and affiliates. Since April 25Subsidiaries, 2021, except for rule making or similar proceedings of general applicability to persons engaged in substantially the Company, its Subsidiaries and affiliates have not received any notice or complaint from any Person, including any Governmental Entity regarding same business conducted by the unauthorized processing of PHI or non-compliance with applicable Healthcare Privacy and Security Laws. Neither the Company, nor its Subsidiaries and their respective affiliates engage in the sale of PHI, as the term “sale” is defined by applicable lawCompany Stations.
Appears in 1 contract
Compliance with Laws and Orders. (a) The Company and its Subsidiaries each Company Subsidiary hold all licenses, franchises, permits and authorizations necessary for the lawful conduct of their respective businesses under and pursuant to each, and have complied in all respects with and are not in compliance and since April 25default in any respect under any, 2021 have been in compliance with all Laws (including all Health Care Laws) and Orders applicable law, statute, order, rule, regulation, policy or guideline of any Governmental Entity relating to the Company or any of its Subsidiaries or any assets owned or used by any of them (except for any such past noncompliance as has been remedied and imposes no continuing obligations or costs on the Company or its Subsidiaries)Subsidiary, except where any the failure to hold such non-compliancelicense, franchise, permit or authorization or such noncompliance or default is not reasonably likely to have, either individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect. Neither the Company nor any of its Subsidiaries has received any written communication since April 25, 2021, from any Governmental Entity that alleges that the Company or any of its Subsidiaries is not in compliance with any such Law or Order, except where any such non-compliance, individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect.
(b) Since April 25, 2021, there has not been and currently there is no Proceeding pending against Except as set forth in the Company Disclosure Letter or any of its Subsidiaries under any federal or state whistleblower statute, including under as disclosed in the False Claims Act, 31 U.S.C. §§ 3729-3733 and Company Reports filed by Company with the Commission prior to the Knowledge date of this Agreement, the businesses of Company and each Company Subsidiary are not being conducted in violation of any law, ordinance, regulation, judgment, order, decree, license or permit of any Governmental Entity (including, without limitation, in the case of a Company Subsidiary that is a bank, all statutes, rules and regulations pertaining to the conduct of the Companybanking business and the exercise of trust powers), except for violations which individually or in the aggregate do not, and, insofar as reasonably can be foreseen, in the future will not, have a Material Adverse Effect. Except as set forth in the Company Disclosure Letter, no such Proceeding has been threatened. Neither the Company nor any of its Subsidiaries is a party to investigation or has any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed review by any Governmental Entity with respect to Company or any Health Care LawCompany Subsidiary is pending or, to the knowledge of Company threatened, nor has any Governmental Entity indicated an intention to conduct the same in each case other than those the outcome of which will not have a Material Adverse Effect.
(c) Neither the Company nor any of its Subsidiaries hasExcept as is not reasonably likely to have, since April 25, 2021, received or retained any payment in violation of applicable Health Care Laws or legally enforceable Health Care Program requirements (except for any such past violation as has been remedied and imposes no continuing obligations or costs on the Company or its Subsidiaries), except where any such violation, either individually or in the aggregate, a Material Adverse Effect, Company and each Company Subsidiary have properly administered all accounts for which its acts as a fiduciary, including accounts for which it serves as a trustee, agent, custodian, personal representative, guardian, conservator or investment advisor, in accordance with the terms of the governing documents, applicable state and federal law and regulation and common law. None of Company, any Company Subsidiary, or any director, officer or employee of Company or of any Company Subsidiary, has not had, and would not committed any breach of trust or fiduciary duty with respect to any such fiduciary account that is reasonably be expected likely to have, either individually or in the aggregate, a Company Material Adverse Effect.
(d) Since April 25, 2021, the Company and its Subsidiaries have not (i) had any product or manufacturing site (whether Company- or Subsidiary-owned) subject to a Governmental Entity (including the U.S. Food and Drug Administration (“FDA”)) shutdown or import or export prohibition, nor (ii) received any FDA Form 483 or other notice from a Governmental Entity of inspectional observations, notice of adverse finding, notice of violation, “warning letters,” “untitled letters” or requests or requirements to make changes to the products that if not complied with would reasonably be expected to have a Company Material Adverse Effect, and, to the Knowledge of the Company, no Governmental Entity has threatened any such action.
(e) The Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors have maintained and filed with the FDA and other Governmental Entities all material reports, data, documents, forms, notices, applications, records and claims that are necessary to comply in all material respects with applicable Health Care Laws. To the Knowledge of the Company, all such reports, data, documents, forms, notices, applications, records, claims, and other filings to the FDA and any similar Governmental Entity by the Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors were true, accurate and complete in all material respects except as of the date made, and, to the extent required to be updated, have been updated to be true, accurate and complete in all material respects as of the date of such update.
(f) None of the Company and its Subsidiaries, or their respective affiliates or, to the Knowledge of the Company, their employees, agents, or contractors is the subject of any pending or, to the Knowledge of the Company, threatened Proceeding in respect of the Company, its Subsidiaries, or any Company Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto.
(g) None of the Company and its Subsidiaries, or their respective affiliates or their officers, employees, agents, or contractors has been suspended, excluded, debarred, or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. §§ 335(a)–(b) or any similar Law, (ii) exclusion under 42 U.S.C. § 1320a-7 in any federal or state health care program or any similar Law, (iii) prohibition from participating in any procurement program of or otherwise contracting with any Governmental Entity, or (iv) assessment of penalties under any Health Care Law, nor are any such advanced actions threatened or reasonably foreseeable. As of the date hereof, no Proceedings that would reasonably be expected to result in any such material debarment, exclusion, prohibition, or assessment of penalties are pending or, to the Knowledge of the Company, threatened against the Company, its Subsidiaries, or any of their respective affiliates or their officers, employees, agents, or contractors.
(h) The Company and its Subsidiaries, and their respective affiliates have in place an operational regulatory compliance program that governs all employees, agents, and contractors and that is designed to address compliance with all applicable Health Care Laws. The Company and its Subsidiaries, and their respective affiliates operate in compliance with such regulatory compliance program in all material respects, except where noncompliance has not had and would not be reasonably be expected likely to have have, either individually or in the aggregate, a Company Material Adverse Effect.
(i) Since April 25, 2021, the Company accountings for each such fiduciary account are true and each of its Subsidiaries, correct and each of their respective officers, directors, or Employees and, to accurately reflect the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries (i) have at all times been in material compliance with all Laws relating to export, reexport, transfer, and import control, economic and trade sanctions, and trade embargo statutes, regulations, decrees, orders, guidelines and policies of the United States government and the government of any country in which it conducts business including but not limited to the Export Administration Regulations (“EAR”) (15 C.F.R. Parts 730-774 (2022)) of the U.S. Department of Commerce; the U.S. antiboycott regulations and guidelines, including those under the EAR and U.S. Department of the Treasury regulations; the various economic sanctions regulations and guidelines of the U.S. Department of the Treasury, Office of Foreign Assets Control, and the USA Patriot Act (Title III of Pub. L. 107-56, signed into Law October 26, 2001), as amended; and restrictions against dealings with certain prohibited, debarred, denied or specially designated entities or individuals under statutes, regulations, orders, and decrees of various agencies of the United States government (collectively, “Trade Controls”); or (ii) have not engaged in any dealings or transactions with or for the benefit of any Sanctioned Person or in any Sanctioned Country.
(j) Neither the Company, nor any of its Subsidiaries, nor any of their respective officers, directors, Employees or, to the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries, has made, offered, promised or authorized any gift or payment of anything of value, directly or indirectly, to or for the benefit of any government official, or any other person, in order to assist the Company in obtaining or retaining business or otherwise securing any improper advantage in violation of applicable Anti-Corruption Laws.
(k) Neither the Company nor any of its Subsidiaries has received from any Governmental Entity or any Person any notice, inquiry, or internal or external allegation; made any voluntary or involuntary disclosure to a Governmental Entity; or conducted any internal investigation or audit concerning any actual or potential violation or wrongdoing in each case, related to Trade Controls or Anti-Corruption Laws.
(l) Since April 25, 2021 neither the Company nor its Subsidiaries or their respective affiliates or their employees, agents or contractors has entered into any arrangement involving the offering or paying any remuneration (including any kickback, bribe, discount or rebate), directly or indirectly, overtly or covertly in cash or in kind to any Person: (i) in return for referring an individual to the Company or any of its Subsidiaries for the furnishing or arranging for the furnishing of any item, product or services for which payment may be made in whole or in part by any Health Care Program or commercial health insurer; or (ii) in return for purchasing, leasing or ordering or arranging for or recommending, purchasing, leasing or ordering any item, product, facility or service from or to the Company or any of its Subsidiaries for which payment may be made in whole or in part by any Health Care Program or commercial health insurer. There are no current arrangements relating to the Company or any of its Subsidiaries providing for any rebates, kickback or other forms of compensation that are unlawful to be paid to any Person in return for the referral or generation of business to the Company or any of its Subsidiaries or for the arrangement for recommendation assets of such referrals or business. Since April 25, 2021, the Company enters into written agreements with each of its independent contractor health care providers and sales and marketing personnel in compliance with the AKS Personal Services and Management Contracts safe harbor (as set forth at 42 C.F.R. § 1001.952 (d))fiduciary account.
(m) The Company and its Subsidiaries and affiliates are and since April 25, 2021 have been in material compliance with all applicable Healthcare Privacy and Security Laws. Since April 25, 2021, no Breach (as that term is defined in HIPAA) has occurred with respect to any unsecured Protected Health Information (as that term is defined in HIPAA) (“PHI”) maintained by or for the Company, any of its Subsidiaries and affiliates. Since April 25, 2021, the Company, its Subsidiaries and affiliates have not received any notice or complaint from any Person, including any Governmental Entity regarding the unauthorized processing of PHI or non-compliance with applicable Healthcare Privacy and Security Laws. Neither the Company, nor its Subsidiaries and their respective affiliates engage in the sale of PHI, as the term “sale” is defined by applicable law.
Appears in 1 contract
Compliance with Laws and Orders. (a) The Company Acquiror has complied, and its Subsidiaries are is now and at the Closing Date will be in compliance and since April 25with, 2021 have been in compliance with to Acquiror's Knowledge, all Laws (including all Health Care Laws) and Orders applicable to the Company or any of its Subsidiaries or any assets owned or used by any of them (law except for any such past noncompliance as has been remedied and imposes no continuing obligations or costs on the Company or its Subsidiaries), except where any such non-compliancewhich, individually or in the aggregate, would not be material to Acquiror's business. Acquiror holds all permits, licenses, exemptions, orders and approvals from and has made all filings with Governmental Entities that are necessary for Acquiror to continue to conduct Acquiror's business as presently conducted without violation of applicable law ("Acquiror Governmental Permits") that are necessary for Acquiror to continue to conduct Acquiror's business substantially as presently conducted without any violation of applicable law and all such Acquiror Governmental Permits are in full force and effect. Acquiror has not had, and would not reasonably be expected to have, a Company Material Adverse Effect. Neither the Company nor any of its Subsidiaries has received any written notice or other communication since April 25, 2021, from any Governmental Entity that alleges that the Company regarding (i) any actual or possible violation of law or any Acquiror Governmental Permit or any failure to comply with any term or requirement of its Subsidiaries any Acquiror Governmental Permit, or (ii) any actual or possible revocation, withdrawal, suspension, cancellation, termination or modification of any Acquiror Governmental Permit. Acquiror is not in compliance subject to any reporting or filing requirement with or to any Governmental Entity, or under applicable law, or pursuant to any Acquiror Governmental Permit other than such Law requirements which are applicable to companies similarly situated to Acquiror. Neither Acquiror nor any director, officer, agent or Orderemployee of Acquiror has, except where for or on behalf of Acquiror, (i) used any such non-compliancefunds for unlawful contributions, individually gifts, entertainment or in the aggregateother unlawful expenses relating to political activity, has not had, and would not reasonably be expected (ii) made any unlawful payment to have, a Company Material Adverse Effect.
(b) Since April 25, 2021, there has not been and currently there is no Proceeding pending against the Company foreign or domestic government officials or employees or to foreign or domestic political parties or campaigns or violated any of its Subsidiaries under any federal or state whistleblower statute, including under the False Claims Act, 31 U.S.C. §§ 3729-3733 and to the Knowledge provision of the CompanyForeign Corrupt Practices Act of 1977, no such Proceeding has been threatened. Neither the Company nor any of its Subsidiaries is a party to or has any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement ordersas amended, or similar agreements with or imposed by (iii) made any Governmental Entity with respect to any Health Care Law.
(c) Neither the Company nor any of its Subsidiaries has, since April 25, 2021, received or retained any other payment in violation of applicable Health Care Laws or legally enforceable Health Care Program requirements (except law, which violation for any such past violation as has been remedied and imposes no continuing obligations or costs on the Company or its Subsidiaries), except where any such violation, individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect.
(d) Since April 25, 2021, the Company and its Subsidiaries have not (i) had any product or manufacturing site (whether Company- or Subsidiary-owned) subject to a Governmental Entity (including the U.S. Food and Drug Administration (“FDA”)) shutdown or import or export prohibition, nor (ii) received any FDA Form 483 or other notice from a Governmental Entity purposes of inspectional observations, notice of adverse finding, notice of violation, “warning letters,” “untitled letters” or requests or requirements to make changes to the products that if not complied with would reasonably be expected to have a Company Material Adverse Effect, and, to the Knowledge of the Company, no Governmental Entity has threatened any such action.
(e) The Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors have maintained and filed with the FDA and other Governmental Entities all material reports, data, documents, forms, notices, applications, records and claims that are necessary to comply in all material respects with applicable Health Care Laws. To the Knowledge of the Company, all such reports, data, documents, forms, notices, applications, records, claims, and other filings to the FDA and any similar Governmental Entity by the Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, have been updated to be true, accurate and complete in all material respects as of the date of such update.
(f) None of the Company and its Subsidiaries, or their respective affiliates or, to the Knowledge of the Company, their employees, agents, or contractors is the subject of any pending or, to the Knowledge of the Company, threatened Proceeding in respect of the Company, its Subsidiaries, or any Company Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto.
(g) None of the Company and its Subsidiaries, or their respective affiliates or their officers, employees, agents, or contractors has been suspended, excluded, debarred, or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. §§ 335(a)–(b) or any similar Law, (ii) exclusion under 42 U.S.C. § 1320a-7 in any federal or state health care program or any similar Law, clause (iii) prohibition from participating in any procurement program of or otherwise contracting with any Governmental Entityonly, or (iv) assessment of penalties under any Health Care Law, nor are any such advanced actions threatened or reasonably foreseeable. As of the date hereof, no Proceedings that would reasonably be expected is not materially adverse to result in any such material debarment, exclusion, prohibition, or assessment of penalties are pending or, to the Knowledge of the Company, threatened against the Company, its Subsidiaries, or any of their respective affiliates or their officers, employees, agents, or contractorsAcquiror's business.
(h) The Company and its Subsidiaries, and their respective affiliates have in place an operational regulatory compliance program that governs all employees, agents, and contractors and that is designed to address compliance with all applicable Health Care Laws. The Company and its Subsidiaries, and their respective affiliates operate in compliance with such regulatory compliance program in all material respects, except where noncompliance has not had and would not reasonably be expected to have a Company Material Adverse Effect.
(i) Since April 25, 2021, the Company and each of its Subsidiaries, and each of their respective officers, directors, or Employees and, to the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries (i) have at all times been in material compliance with all Laws relating to export, reexport, transfer, and import control, economic and trade sanctions, and trade embargo statutes, regulations, decrees, orders, guidelines and policies of the United States government and the government of any country in which it conducts business including but not limited to the Export Administration Regulations (“EAR”) (15 C.F.R. Parts 730-774 (2022)) of the U.S. Department of Commerce; the U.S. antiboycott regulations and guidelines, including those under the EAR and U.S. Department of the Treasury regulations; the various economic sanctions regulations and guidelines of the U.S. Department of the Treasury, Office of Foreign Assets Control, and the USA Patriot Act (Title III of Pub. L. 107-56, signed into Law October 26, 2001), as amended; and restrictions against dealings with certain prohibited, debarred, denied or specially designated entities or individuals under statutes, regulations, orders, and decrees of various agencies of the United States government (collectively, “Trade Controls”); or (ii) have not engaged in any dealings or transactions with or for the benefit of any Sanctioned Person or in any Sanctioned Country.
(j) Neither the Company, nor any of its Subsidiaries, nor any of their respective officers, directors, Employees or, to the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries, has made, offered, promised or authorized any gift or payment of anything of value, directly or indirectly, to or for the benefit of any government official, or any other person, in order to assist the Company in obtaining or retaining business or otherwise securing any improper advantage in violation of applicable Anti-Corruption Laws.
(k) Neither the Company nor any of its Subsidiaries has received from any Governmental Entity or any Person any notice, inquiry, or internal or external allegation; made any voluntary or involuntary disclosure to a Governmental Entity; or conducted any internal investigation or audit concerning any actual or potential violation or wrongdoing in each case, related to Trade Controls or Anti-Corruption Laws.
(l) Since April 25, 2021 neither the Company nor its Subsidiaries or their respective affiliates or their employees, agents or contractors has entered into any arrangement involving the offering or paying any remuneration (including any kickback, bribe, discount or rebate), directly or indirectly, overtly or covertly in cash or in kind to any Person: (i) in return for referring an individual to the Company or any of its Subsidiaries for the furnishing or arranging for the furnishing of any item, product or services for which payment may be made in whole or in part by any Health Care Program or commercial health insurer; or (ii) in return for purchasing, leasing or ordering or arranging for or recommending, purchasing, leasing or ordering any item, product, facility or service from or to the Company or any of its Subsidiaries for which payment may be made in whole or in part by any Health Care Program or commercial health insurer. There are no current arrangements relating to the Company or any of its Subsidiaries providing for any rebates, kickback or other forms of compensation that are unlawful to be paid to any Person in return for the referral or generation of business to the Company or any of its Subsidiaries or for the arrangement for recommendation of such referrals or business. Since April 25, 2021, the Company enters into written agreements with each of its independent contractor health care providers and sales and marketing personnel in compliance with the AKS Personal Services and Management Contracts safe harbor (as set forth at 42 C.F.R. § 1001.952 (d)).
(m) The Company and its Subsidiaries and affiliates are and since April 25, 2021 have been in material compliance with all applicable Healthcare Privacy and Security Laws. Since April 25, 2021, no Breach (as that term is defined in HIPAA) has occurred with respect to any unsecured Protected Health Information (as that term is defined in HIPAA) (“PHI”) maintained by or for the Company, any of its Subsidiaries and affiliates. Since April 25, 2021, the Company, its Subsidiaries and affiliates have not received any notice or complaint from any Person, including any Governmental Entity regarding the unauthorized processing of PHI or non-compliance with applicable Healthcare Privacy and Security Laws. Neither the Company, nor its Subsidiaries and their respective affiliates engage in the sale of PHI, as the term “sale” is defined by applicable law.
Appears in 1 contract
Samples: Agreement and Plan of Reorganization (Simplex Solutions Inc)
Compliance with Laws and Orders. (a) The Company and its Subsidiaries are Except as set forth in compliance and since April 25, 2021 have been the Acquiror Disclosure Schedule or as disclosed in compliance the reports described in Section 4.8.1 filed by the Acquiror with all Laws (including all Health Care Laws) and Orders applicable the SEC prior to the Company date of this Agreement, the businesses of the Acquiror and the Acquiror Subsidiaries have not been, and are not being, conducted in violation of any law, ordinance, regulation, judgment, order, decree, license or permit of any governmental entity (including, without limitation, in the case of its Acquiror Subsidiaries or any assets owned or used by any that are banks, all statutes, rules and regulations pertaining to the conduct of them (except for any such past noncompliance as has been remedied the banking business and imposes no continuing obligations or costs on the Company or its Subsidiariesexercise of trust powers), except where any such non-compliance, for violations which individually or in the aggregateaggregate do not, has not hadand, and would not insofar as reasonably can be expected to haveforeseen, in the future shall not, have a Company Material Adverse EffectEffect on the Acquiror and the Acquiror Subsidiaries, taken as a whole. Neither Except as set forth in the Company nor any of its Subsidiaries has received any written communication since April 25Acquiror Disclosure Schedule, 2021, from no investigation or review by any Governmental Entity that alleges that Authority with respect to the Company Acquiror or any of its the Acquiror Subsidiaries is not in compliance with any such Law or Order, except where any such non-compliance, individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect.
(b) Since April 25, 2021, there has not been and currently there is no Proceeding pending against the Company or any of its Subsidiaries under any federal or state whistleblower statute, including under the False Claims Act, 31 U.S.C. §§ 3729-3733 and to the Knowledge of the Company, no such Proceeding has been threatened. Neither the Company nor any of its Subsidiaries is a party to or has any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity with respect to any Health Care Law.
(c) Neither the Company nor any of its Subsidiaries has, since April 25, 2021, received or retained any payment in violation of applicable Health Care Laws or legally enforceable Health Care Program requirements (except for any such past violation as has been remedied and imposes no continuing obligations or costs on the Company or its Subsidiaries), except where any such violation, individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect.
(d) Since April 25, 2021, the Company and its Subsidiaries have not (i) had any product or manufacturing site (whether Company- or Subsidiary-owned) subject to a Governmental Entity (including the U.S. Food and Drug Administration (“FDA”)) shutdown or import or export prohibition, nor (ii) received any FDA Form 483 or other notice from a Governmental Entity of inspectional observations, notice of adverse finding, notice of violation, “warning letters,” “untitled letters” or requests or requirements to make changes to the products that if not complied with would reasonably be expected to have a Company Material Adverse Effect, and, to the Knowledge of the Company, no Governmental Entity has threatened any such action.
(e) The Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors have maintained and filed with the FDA and other Governmental Entities all material reports, data, documents, forms, notices, applications, records and claims that are necessary to comply in all material respects with applicable Health Care Laws. To the Knowledge of the Company, all such reports, data, documents, forms, notices, applications, records, claims, and other filings to the FDA and any similar Governmental Entity by the Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, have been updated to be true, accurate and complete in all material respects as of the date of such update.
(f) None of the Company and its Subsidiaries, or their respective affiliates or, to the Knowledge of the Company, their employees, agents, or contractors is the subject of any pending or, to the Knowledge knowledge of the CompanyAcquiror, threatened Proceeding in respect of the Companythreatened, its Subsidiaries, or any Company Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto.
(g) None of the Company and its Subsidiaries, or their respective affiliates or their officers, employees, agents, or contractors nor has been suspended, excluded, debarred, or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. §§ 335(a)–(b) or any similar Law, (ii) exclusion under 42 U.S.C. § 1320a-7 in any federal or state health care program or any similar Law, (iii) prohibition from participating in any procurement program of or otherwise contracting with any Governmental EntityAuthority indicated an intention to conduct the same, or (iv) assessment in each case other than those the outcome of penalties under any Health Care Law, nor are any such advanced actions threatened or reasonably foreseeable. As of the date hereof, no Proceedings that would reasonably be expected to result in any such material debarment, exclusion, prohibition, or assessment of penalties are pending or, to the Knowledge of the Company, threatened against the Company, its Subsidiaries, or any of their respective affiliates or their officers, employees, agents, or contractors.
(h) The Company and its Subsidiaries, and their respective affiliates have in place an operational regulatory compliance program that governs all employees, agents, and contractors and that which is designed to address compliance with all applicable Health Care Laws. The Company and its Subsidiaries, and their respective affiliates operate in compliance with such regulatory compliance program in all material respects, except where noncompliance has not had and would not reasonably be expected to have a Company Material Adverse Effect.
(i) Since April 25, 2021, Effect on the Company Acquiror and each of its the Acquiror Subsidiaries, and each of their respective officers, directors, or Employees and, to the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries (i) have at all times been in material compliance with all Laws relating to export, reexport, transfer, and import control, economic and trade sanctions, and trade embargo statutes, regulations, decrees, orders, guidelines and policies of the United States government and the government of any country in which it conducts business including but not limited to the Export Administration Regulations (“EAR”) (15 C.F.R. Parts 730-774 (2022)) of the U.S. Department of Commerce; the U.S. antiboycott regulations and guidelines, including those under the EAR and U.S. Department of the Treasury regulations; the various economic sanctions regulations and guidelines of the U.S. Department of the Treasury, Office of Foreign Assets Control, and the USA Patriot Act (Title III of Pub. L. 107-56, signed into Law October 26, 2001), taken as amended; and restrictions against dealings with certain prohibited, debarred, denied or specially designated entities or individuals under statutes, regulations, orders, and decrees of various agencies of the United States government (collectively, “Trade Controls”); or (ii) have not engaged in any dealings or transactions with or for the benefit of any Sanctioned Person or in any Sanctioned Countrya whole.
(j) Neither the Company, nor any of its Subsidiaries, nor any of their respective officers, directors, Employees or, to the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries, has made, offered, promised or authorized any gift or payment of anything of value, directly or indirectly, to or for the benefit of any government official, or any other person, in order to assist the Company in obtaining or retaining business or otherwise securing any improper advantage in violation of applicable Anti-Corruption Laws.
(k) Neither the Company nor any of its Subsidiaries has received from any Governmental Entity or any Person any notice, inquiry, or internal or external allegation; made any voluntary or involuntary disclosure to a Governmental Entity; or conducted any internal investigation or audit concerning any actual or potential violation or wrongdoing in each case, related to Trade Controls or Anti-Corruption Laws.
(l) Since April 25, 2021 neither the Company nor its Subsidiaries or their respective affiliates or their employees, agents or contractors has entered into any arrangement involving the offering or paying any remuneration (including any kickback, bribe, discount or rebate), directly or indirectly, overtly or covertly in cash or in kind to any Person: (i) in return for referring an individual to the Company or any of its Subsidiaries for the furnishing or arranging for the furnishing of any item, product or services for which payment may be made in whole or in part by any Health Care Program or commercial health insurer; or (ii) in return for purchasing, leasing or ordering or arranging for or recommending, purchasing, leasing or ordering any item, product, facility or service from or to the Company or any of its Subsidiaries for which payment may be made in whole or in part by any Health Care Program or commercial health insurer. There are no current arrangements relating to the Company or any of its Subsidiaries providing for any rebates, kickback or other forms of compensation that are unlawful to be paid to any Person in return for the referral or generation of business to the Company or any of its Subsidiaries or for the arrangement for recommendation of such referrals or business. Since April 25, 2021, the Company enters into written agreements with each of its independent contractor health care providers and sales and marketing personnel in compliance with the AKS Personal Services and Management Contracts safe harbor (as set forth at 42 C.F.R. § 1001.952 (d)).
(m) The Company and its Subsidiaries and affiliates are and since April 25, 2021 have been in material compliance with all applicable Healthcare Privacy and Security Laws. Since April 25, 2021, no Breach (as that term is defined in HIPAA) has occurred with respect to any unsecured Protected Health Information (as that term is defined in HIPAA) (“PHI”) maintained by or for the Company, any of its Subsidiaries and affiliates. Since April 25, 2021, the Company, its Subsidiaries and affiliates have not received any notice or complaint from any Person, including any Governmental Entity regarding the unauthorized processing of PHI or non-compliance with applicable Healthcare Privacy and Security Laws. Neither the Company, nor its Subsidiaries and their respective affiliates engage in the sale of PHI, as the term “sale” is defined by applicable law.
Appears in 1 contract
Compliance with Laws and Orders. (a) The Company Harbor and its Subsidiaries each Harbor Subsidiary hold all licenses, franchises, permits and authorizations necessary for the lawful conduct of their respective businesses under and pursuant to each, and have complied in all respects with and are not in compliance and since April 25default in any respect under any, 2021 have been in compliance with all Laws (including all Health Care Laws) and Orders applicable law, statute, order, rule, regulation, policy or guideline of any Governmental Authority relating to the Company Harbor or any of its Subsidiaries or any assets owned or used by any of them (except for any such past noncompliance as has been remedied and imposes no continuing obligations or costs on the Company or its Subsidiaries)Harbor Subsidiary, except where any the failure to hold such non-compliancelicense, franchise, permit or authorization or such noncompliance or default is not reasonably likely to have, either individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect. Neither the Company nor any of its Subsidiaries has received any written communication since April 25, 2021, from any Governmental Entity that alleges that the Company or any of its Subsidiaries is not in compliance with any such Law or Order, except where any such non-compliance, individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect.
(b) Since April 25, 2021, there has not been and currently there is no Proceeding pending against Except as disclosed in Harbor Reports filed by Harbor with the Company or any of its Subsidiaries under any federal or state whistleblower statute, including under the False Claims Act, 31 U.S.C. §§ 3729-3733 and SEC prior to the Knowledge date of this Agreement, the Company, no such Proceeding has been threatened. Neither the Company nor any businesses of its Subsidiaries is a party to or has any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity with respect to any Health Care Law.
(c) Neither the Company nor any of its Subsidiaries has, since April 25, 2021, received or retained any payment Harbor and each Harbor Subsidiary are not being conducted in violation of applicable Health Care Laws any law, ordinance, regulation, judgment, order, decree, license or legally enforceable Health Care Program requirements permit of any Governmental Authority (except for any such past violation as has been remedied including, without limitation, in the case of a Harbor Subsidiary that is a thrift, all statutes, rules and imposes no continuing obligations or costs on regulations pertaining to the Company or its Subsidiariesconduct of the banking business and the exercise of trust powers), except where any such violation, for violations which individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect.
(d) Since April 25, 2021, the Company and its Subsidiaries have not (i) had any product or manufacturing site (whether Company- or Subsidiary-owned) subject to a Governmental Entity (including the U.S. Food and Drug Administration (“FDA”)) shutdown or import or export prohibition, nor (ii) received any FDA Form 483 or other notice from a Governmental Entity of inspectional observations, notice of adverse finding, notice of violation, “warning letters,” “untitled letters” or requests or requirements to make changes to the products that if not complied with would reasonably be expected to have a Company Material Adverse Effectaggregate do not, and, to the Knowledge of Harbor, will not, have a Material Adverse Effect. Harbor's Subsidiaries that are banks or thrifts are not in violation of those laws applicable to depository institutions, and corresponding regulations and policies relating to the CompanyCRA, privacy laws, the BSA or anti-money laundering statutes in a manner that would materially delay the receipt of approvals of Governmental Entities required to consummate the transactions contemplated in this Agreement. Other than regulatory examinations conducted in the ordinary course, no investigation or review by any Governmental Entity has threatened Authority with respect to Harbor or any such action.
(e) The Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors have maintained and filed with the FDA and other Governmental Entities all material reports, data, documents, forms, notices, applications, records and claims that are necessary to comply in all material respects with applicable Health Care Laws. To the Knowledge of the Company, all such reports, data, documents, forms, notices, applications, records, claims, and other filings to the FDA and any similar Governmental Entity by the Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, have been updated to be true, accurate and complete in all material respects as of the date of such update.
(f) None of the Company and its Subsidiaries, or their respective affiliates or, to the Knowledge of the Company, their employees, agents, or contractors Harbor Subsidiary is the subject of any pending or, to the Knowledge of the CompanyHarbor, threatened Proceeding in respect of the Companythreatened, its Subsidiaries, or any Company Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto.
(g) None of the Company and its Subsidiaries, or their respective affiliates or their officers, employees, agents, or contractors nor has been suspended, excluded, debarred, or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. §§ 335(a)–(b) or any similar Law, (ii) exclusion under 42 U.S.C. § 1320a-7 in any federal or state health care program or any similar Law, (iii) prohibition from participating in any procurement program of or otherwise contracting with any Governmental Entity, or (iv) assessment Authority indicated an intention to conduct the same in each case other than those the outcome of penalties under any Health Care Law, nor are any such advanced actions threatened or reasonably foreseeable. As of the date hereof, no Proceedings that would reasonably be expected to result in any such material debarment, exclusion, prohibition, or assessment of penalties are pending or, to the Knowledge of the Company, threatened against the Company, its Subsidiaries, or any of their respective affiliates or their officers, employees, agents, or contractors.
(h) The Company and its Subsidiaries, and their respective affiliates have in place an operational regulatory compliance program that governs all employees, agents, and contractors and that is designed to address compliance with all applicable Health Care Laws. The Company and its Subsidiaries, and their respective affiliates operate in compliance with such regulatory compliance program in all material respects, except where noncompliance has which will not had and would not reasonably be expected to have a Company Material Adverse Effect.
(ic) Since April 25Except as is not reasonably likely to have, 2021either individually or in the aggregate, the Company a Material Adverse Effect, Harbor and each of its SubsidiariesHarbor Subsidiary have properly administered all accounts for which acts as a fiduciary, and each of their respective officersincluding accounts for which it serves as a trustee, directorsagent, custodian, personal representative, guardian, conservator or Employees andinvestment advisor, to in accordance with the Knowledge terms of the Companygoverning documents, applicable state and federal law and regulation and common law. None of Harbor, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries (i) have at all times been in material compliance with all Laws relating to export, reexport, transfer, and import control, economic and trade sanctions, and trade embargo statutes, regulations, decrees, orders, guidelines and policies of the United States government and the government of any country in which it conducts business including but not limited to the Export Administration Regulations (“EAR”) (15 C.F.R. Parts 730-774 (2022)) of the U.S. Department of Commerce; the U.S. antiboycott regulations and guidelines, including those under the EAR and U.S. Department of the Treasury regulations; the various economic sanctions regulations and guidelines of the U.S. Department of the Treasury, Office of Foreign Assets Control, and the USA Patriot Act (Title III of Pub. L. 107-56, signed into Law October 26, 2001), as amended; and restrictions against dealings with certain prohibited, debarred, denied or specially designated entities or individuals under statutes, regulations, orders, and decrees of various agencies of the United States government (collectively, “Trade Controls”); or (ii) have not engaged in any dealings or transactions with or for the benefit of any Sanctioned Person or in any Sanctioned Country.
(j) Neither the Company, nor any of its Subsidiaries, nor any of their respective officers, directors, Employees or, to the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries, has made, offered, promised or authorized any gift or payment of anything of value, directly or indirectly, to or for the benefit of any government officialHarbor Subsidiary, or any other persondirector, in order to assist the Company in obtaining officer or retaining business employee of Harbor or otherwise securing any improper advantage in violation of applicable Anti-Corruption Laws.
(k) Neither the Company nor any of its Subsidiaries has received from any Governmental Entity or any Person any notice, inquiry, or internal or external allegation; made any voluntary or involuntary disclosure to a Governmental Entity; or conducted any internal investigation or audit concerning any actual or potential violation or wrongdoing in each case, related to Trade Controls or Anti-Corruption Laws.
(l) Since April 25, 2021 neither the Company nor its Subsidiaries or their respective affiliates or their employees, agents or contractors has entered into any arrangement involving the offering or paying any remuneration (including any kickback, bribe, discount or rebate), directly or indirectly, overtly or covertly in cash or in kind to any Person: (i) in return for referring an individual to the Company or any of its Subsidiaries for the furnishing or arranging for the furnishing of any itemHarbor Subsidiary, product has committed any breach of trust or services for which payment may be made in whole or in part by any Health Care Program or commercial health insurer; or (ii) in return for purchasing, leasing or ordering or arranging for or recommending, purchasing, leasing or ordering any item, product, facility or service from or to the Company or any of its Subsidiaries for which payment may be made in whole or in part by any Health Care Program or commercial health insurer. There are no current arrangements relating to the Company or any of its Subsidiaries providing for any rebates, kickback or other forms of compensation that are unlawful to be paid to any Person in return for the referral or generation of business to the Company or any of its Subsidiaries or for the arrangement for recommendation of such referrals or business. Since April 25, 2021, the Company enters into written agreements with each of its independent contractor health care providers and sales and marketing personnel in compliance with the AKS Personal Services and Management Contracts safe harbor (as set forth at 42 C.F.R. § 1001.952 (d)).
(m) The Company and its Subsidiaries and affiliates are and since April 25, 2021 have been in material compliance with all applicable Healthcare Privacy and Security Laws. Since April 25, 2021, no Breach (as that term is defined in HIPAA) has occurred fiduciary duty with respect to any unsecured Protected Health Information (as such fiduciary account that term is defined in HIPAA) (“PHI”) maintained by reasonably likely to have, either individually or for the Company, any of its Subsidiaries and affiliates. Since April 25, 2021, the Company, its Subsidiaries and affiliates have not received any notice or complaint from any Person, including any Governmental Entity regarding the unauthorized processing of PHI or non-compliance with applicable Healthcare Privacy and Security Laws. Neither the Company, nor its Subsidiaries and their respective affiliates engage in the sale aggregate, a Material Adverse Effect, and, except as would not be reasonably likely to have, either individually or in the aggregate, a Material Adverse Effect, and the accountings for each such fiduciary account are true and correct and accurately reflect the assets of PHI, as the term “sale” is defined by applicable lawsuch fiduciary account.
Appears in 1 contract
Compliance with Laws and Orders. (a) The Company Fidelity and its Subsidiaries each Fidelity Subsidiary hold all licenses, franchises, permits and authorizations necessary for the lawful conduct of their respective businesses under and pursuant to each, and have complied in all respects with and are not in compliance and since April 25default in any respect under any, 2021 have been in compliance with all Laws (including all Health Care Laws) and Orders applicable Law, statute, order, rule, regulation, policy or guideline of any Governmental Authority relating to the Company Fidelity or any of its Subsidiaries or any assets owned or used by any of them (except for any such past noncompliance as has been remedied and imposes no continuing obligations or costs on the Company or its Subsidiaries)Fidelity Subsidiary, except where any the failure to hold such non-compliancelicense, franchise, permit or authorization or such noncompliance or default is not reasonably likely to have, either individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect. Neither the Company nor any of its Subsidiaries has received any written communication since April 25, 2021, from any Governmental Entity that alleges that the Company or any of its Subsidiaries is not in compliance with any such Law or Order, except where any such non-compliance, individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect.
(b) Since April 25, 2021, there has not been and currently there is no Proceeding pending against Except as disclosed in Fidelity Reports filed by Fidelity with the Company or any of its Subsidiaries under any federal or state whistleblower statute, including under the False Claims Act, 31 U.S.C. §§ 3729-3733 and Commission prior to the Knowledge date of this Agreement, the Company, no such Proceeding has been threatened. Neither the Company nor any businesses of its Subsidiaries is a party to or has any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity with respect to any Health Care Law.
(c) Neither the Company nor any of its Subsidiaries has, since April 25, 2021, received or retained any payment Fidelity and each Fidelity Subsidiary are not being conducted in violation of applicable Health Care any Law or Governmental Order of any Governmental Authority (including, without limitation, in the case of a Fidelity Subsidiary that is a thrift, all Laws or legally enforceable Health Care Program requirements (except for any such past violation as has been remedied pertaining to the conduct of the banking business and imposes no continuing obligations or costs on the Company or its Subsidiariesexercise of trust powers), except where any such violation, for violations which individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect.
(d) Since April 25, 2021, the Company and its Subsidiaries have not (i) had any product or manufacturing site (whether Company- or Subsidiary-owned) subject to a Governmental Entity (including the U.S. Food and Drug Administration (“FDA”)) shutdown or import or export prohibition, nor (ii) received any FDA Form 483 or other notice from a Governmental Entity of inspectional observations, notice of adverse finding, notice of violation, “warning letters,” “untitled letters” or requests or requirements to make changes to the products that if not complied with would reasonably be expected to have a Company Material Adverse Effectaggregate do not, and, to the Knowledge of Fidelity, will not, have a Material Adverse Effect. Fidelity's Subsidiaries that are thrifts are not in violation of those Laws applicable to depository institutions, and corresponding regulations and policies relating to the CompanyCRA, privacy Laws, the BSA or anti-money laundering statutes in a manner that would materially delay the receipt of approvals of Governmental Authorities required to consummate the transactions contemplated in this Agreement. Other than regulatory examinations conducted in the ordinary course, no investigation or review by any Governmental Entity has threatened Authority with respect to Fidelity or any such action.
(e) The Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors have maintained and filed with the FDA and other Governmental Entities all material reports, data, documents, forms, notices, applications, records and claims that are necessary to comply in all material respects with applicable Health Care Laws. To the Knowledge of the Company, all such reports, data, documents, forms, notices, applications, records, claims, and other filings to the FDA and any similar Governmental Entity by the Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, have been updated to be true, accurate and complete in all material respects as of the date of such update.
(f) None of the Company and its Subsidiaries, or their respective affiliates or, to the Knowledge of the Company, their employees, agents, or contractors Fidelity Subsidiary is the subject of any pending or, to the Knowledge of the CompanyFidelity, threatened Proceeding in respect of the Companythreatened, its Subsidiaries, or any Company Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto.
(g) None of the Company and its Subsidiaries, or their respective affiliates or their officers, employees, agents, or contractors nor has been suspended, excluded, debarred, or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. §§ 335(a)–(b) or any similar Law, (ii) exclusion under 42 U.S.C. § 1320a-7 in any federal or state health care program or any similar Law, (iii) prohibition from participating in any procurement program of or otherwise contracting with any Governmental Entity, or (iv) assessment Authority indicated an intention to conduct the same in each case other than those the outcome of penalties under any Health Care Law, nor are any such advanced actions threatened or reasonably foreseeable. As of the date hereof, no Proceedings that would reasonably be expected to result in any such material debarment, exclusion, prohibition, or assessment of penalties are pending or, to the Knowledge of the Company, threatened against the Company, its Subsidiaries, or any of their respective affiliates or their officers, employees, agents, or contractors.
(h) The Company and its Subsidiaries, and their respective affiliates have in place an operational regulatory compliance program that governs all employees, agents, and contractors and that is designed to address compliance with all applicable Health Care Laws. The Company and its Subsidiaries, and their respective affiliates operate in compliance with such regulatory compliance program in all material respects, except where noncompliance has which will not had and would not reasonably be expected to have a Company Material Adverse Effect.
(ic) Since April 25Except as is not reasonably likely to have, 2021either individually or in the aggregate, the Company a Material Adverse Effect, Fidelity and each of its SubsidiariesFidelity Subsidiary have properly administered all accounts for which acts as a fiduciary, and each of their respective officersincluding accounts for which it serves as a trustee, directorsagent, custodian, personal representative, guardian, conservator or Employees andinvestment advisor, to in accordance with the Knowledge terms of the Companygoverning documents, applicable state and federal Law and common law. None of Fidelity, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries (i) have at all times been in material compliance with all Laws relating to export, reexport, transfer, and import control, economic and trade sanctions, and trade embargo statutes, regulations, decrees, orders, guidelines and policies of the United States government and the government of any country in which it conducts business including but not limited to the Export Administration Regulations (“EAR”) (15 C.F.R. Parts 730-774 (2022)) of the U.S. Department of Commerce; the U.S. antiboycott regulations and guidelines, including those under the EAR and U.S. Department of the Treasury regulations; the various economic sanctions regulations and guidelines of the U.S. Department of the Treasury, Office of Foreign Assets Control, and the USA Patriot Act (Title III of Pub. L. 107-56, signed into Law October 26, 2001), as amended; and restrictions against dealings with certain prohibited, debarred, denied or specially designated entities or individuals under statutes, regulations, orders, and decrees of various agencies of the United States government (collectively, “Trade Controls”); or (ii) have not engaged in any dealings or transactions with or for the benefit of any Sanctioned Person or in any Sanctioned Country.
(j) Neither the Company, nor any of its Subsidiaries, nor any of their respective officers, directors, Employees or, to the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries, has made, offered, promised or authorized any gift or payment of anything of value, directly or indirectly, to or for the benefit of any government officialFidelity Subsidiary, or any other persondirector, in order to assist the Company in obtaining officer or retaining business employee of Fidelity or otherwise securing any improper advantage in violation of applicable Anti-Corruption Laws.
(k) Neither the Company nor any of its Subsidiaries has received from any Governmental Entity or any Person any notice, inquiry, or internal or external allegation; made any voluntary or involuntary disclosure to a Governmental Entity; or conducted any internal investigation or audit concerning any actual or potential violation or wrongdoing in each case, related to Trade Controls or Anti-Corruption Laws.
(l) Since April 25, 2021 neither the Company nor its Subsidiaries or their respective affiliates or their employees, agents or contractors has entered into any arrangement involving the offering or paying any remuneration (including any kickback, bribe, discount or rebate), directly or indirectly, overtly or covertly in cash or in kind to any Person: (i) in return for referring an individual to the Company or any of its Subsidiaries for the furnishing or arranging for the furnishing of any itemFidelity Subsidiary, product has committed any breach of trust or services for which payment may be made in whole or in part by any Health Care Program or commercial health insurer; or (ii) in return for purchasing, leasing or ordering or arranging for or recommending, purchasing, leasing or ordering any item, product, facility or service from or to the Company or any of its Subsidiaries for which payment may be made in whole or in part by any Health Care Program or commercial health insurer. There are no current arrangements relating to the Company or any of its Subsidiaries providing for any rebates, kickback or other forms of compensation that are unlawful to be paid to any Person in return for the referral or generation of business to the Company or any of its Subsidiaries or for the arrangement for recommendation of such referrals or business. Since April 25, 2021, the Company enters into written agreements with each of its independent contractor health care providers and sales and marketing personnel in compliance with the AKS Personal Services and Management Contracts safe harbor (as set forth at 42 C.F.R. § 1001.952 (d)).
(m) The Company and its Subsidiaries and affiliates are and since April 25, 2021 have been in material compliance with all applicable Healthcare Privacy and Security Laws. Since April 25, 2021, no Breach (as that term is defined in HIPAA) has occurred fiduciary duty with respect to any unsecured Protected Health Information (as such fiduciary account that term is defined in HIPAA) (“PHI”) maintained by reasonably likely to have, either individually or for the Company, any of its Subsidiaries and affiliates. Since April 25, 2021, the Company, its Subsidiaries and affiliates have not received any notice or complaint from any Person, including any Governmental Entity regarding the unauthorized processing of PHI or non-compliance with applicable Healthcare Privacy and Security Laws. Neither the Company, nor its Subsidiaries and their respective affiliates engage in the sale aggregate, a Material Adverse Effect, and, except as would not be reasonably likely to have, either individually or in the aggregate, a Material Adverse Effect, and the accountings for each such fiduciary account are true and correct and accurately reflect the assets of PHI, as the term “sale” is defined by applicable lawsuch fiduciary account.
Appears in 1 contract
Compliance with Laws and Orders. (a) The Company National City and its Subsidiaries each National City Subsidiary hold all licenses, franchises, permits and authorizations necessary for the lawful conduct of their respective businesses under and pursuant to each, and have complied in all respects with and are not in compliance and since April 25default in any respect under any, 2021 have been in compliance with all Laws (including all Health Care Laws) and Orders applicable Law of any Governmental Authority relating to the Company National City or any of its Subsidiaries or any assets owned or used by any of them (except for any such past noncompliance as has been remedied and imposes no continuing obligations or costs on the Company or its Subsidiaries)National City Subsidiary, except where any the failure to hold such non-compliancelicense, franchise, permit or authorization or such noncompliance or default is not reasonably likely to have, either individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect. Neither the Company nor any of its Subsidiaries has received any written communication since April 25, 2021, from any Governmental Entity that alleges that the Company or any of its Subsidiaries is not in compliance with any such Law or Order, except where any such non-compliance, individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect.
(b) Since April 25, 2021, there has not been and currently there is no Proceeding pending against Except as disclosed in the Company or any of its Subsidiaries under any federal or state whistleblower statute, including under National City Reports filed by National City with the False Claims Act, 31 U.S.C. §§ 3729-3733 and Commission prior to the Knowledge date of this Agreement, the Company, no such Proceeding has been threatened. Neither the Company nor any businesses of its National City and of National City's Subsidiaries is a party to or has any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity with respect to any Health Care Law.
(c) Neither the Company nor any of its Subsidiaries has, since April 25, 2021, received or retained any payment are not being conducted in violation of applicable Health Care any Law or Governmental Order of any Governmental Authority (including, without limitation, in the case of National City's Subsidiaries that are banks, all Laws or legally enforceable Health Care Program requirements (except for any such past violation as has been remedied pertaining to the conduct of the banking business and imposes no continuing obligations or costs on the Company or its Subsidiariesexercise of trust powers), except where any such violation, for violations which individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect.
(d) Since April 25, 2021, the Company and its Subsidiaries have not (i) had any product or manufacturing site (whether Company- or Subsidiary-owned) subject to a Governmental Entity (including the U.S. Food and Drug Administration (“FDA”)) shutdown or import or export prohibition, nor (ii) received any FDA Form 483 or other notice from a Governmental Entity of inspectional observations, notice of adverse finding, notice of violation, “warning letters,” “untitled letters” or requests or requirements to make changes to the products that if not complied with would reasonably be expected to have a Company Material Adverse Effectaggregate do not, and, to the Knowledge of National City, will not, have a Material Adverse Effect. National City's Subsidiaries that are banks are not in violation of those Laws applicable to depository institutions, and corresponding regulations and policies relating to the CompanyCommunity Reinvestment Act ("CRA"), privacy Laws, the Bank Security Act, as amended (the "BSA"), or anti-money laundering statutes in a manner that would materially delay the receipt of approvals of Governmental Authorities required to consummate the transactions contemplated in this Agreement. Other than regulatory examinations conducted in the ordinary course, no investigation or review by any Governmental Entity has threatened Authority with respect to National City or any such action.
(e) The Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors have maintained and filed with the FDA and other Governmental Entities all material reports, data, documents, forms, notices, applications, records and claims that are necessary to comply in all material respects with applicable Health Care Laws. To the Knowledge of the Company, all such reports, data, documents, forms, notices, applications, records, claims, and other filings to the FDA and any similar Governmental Entity by the Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, have been updated to be true, accurate and complete in all material respects as of the date of such update.
(f) None of the Company and its Subsidiaries, or their respective affiliates or, to the Knowledge of the Company, their employees, agents, or contractors National City's Subsidiaries is the subject of any pending or, to the Knowledge of the CompanyNational City, threatened Proceeding in respect of the Companythreatened, its Subsidiaries, or any Company Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto.
(g) None of the Company and its Subsidiaries, or their respective affiliates or their officers, employees, agents, or contractors nor has been suspended, excluded, debarred, or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. §§ 335(a)–(b) or any similar Law, (ii) exclusion under 42 U.S.C. § 1320a-7 in any federal or state health care program or any similar Law, (iii) prohibition from participating in any procurement program of or otherwise contracting with any Governmental Entity, or (iv) assessment Authority indicated an intention to conduct the same in each case other than those the outcome of penalties under any Health Care Law, nor are any such advanced actions threatened or reasonably foreseeable. As of the date hereof, no Proceedings that would reasonably be expected to result in any such material debarment, exclusion, prohibition, or assessment of penalties are pending or, to the Knowledge of the Company, threatened against the Company, its Subsidiaries, or any of their respective affiliates or their officers, employees, agents, or contractors.
(h) The Company and its Subsidiaries, and their respective affiliates have in place an operational regulatory compliance program that governs all employees, agents, and contractors and that is designed to address compliance with all applicable Health Care Laws. The Company and its Subsidiaries, and their respective affiliates operate in compliance with such regulatory compliance program in all material respects, except where noncompliance has which will not had and would not reasonably be expected to have a Company Material Adverse Effect.
(ic) Since April 25Except as is not reasonably likely to have, 2021either individually or in the aggregate, the Company a Material Adverse Effect, National City and each of its SubsidiariesNational City Subsidiary have properly administered all accounts for which it acts as a fiduciary, and each of their respective officersincluding accounts for which it serves as a trustee, directorsagent, custodian, personal representative, guardian, conservator or Employees andinvestment advisor, to in accordance with the Knowledge terms of the Companygoverning documents, applicable state and federal Law and common law. None of National City, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries (i) have at all times been in material compliance with all Laws relating to export, reexport, transfer, and import control, economic and trade sanctions, and trade embargo statutes, regulations, decrees, orders, guidelines and policies of the United States government and the government of any country in which it conducts business including but not limited to the Export Administration Regulations (“EAR”) (15 C.F.R. Parts 730-774 (2022)) of the U.S. Department of Commerce; the U.S. antiboycott regulations and guidelines, including those under the EAR and U.S. Department of the Treasury regulations; the various economic sanctions regulations and guidelines of the U.S. Department of the Treasury, Office of Foreign Assets Control, and the USA Patriot Act (Title III of Pub. L. 107-56, signed into Law October 26, 2001), as amended; and restrictions against dealings with certain prohibited, debarred, denied or specially designated entities or individuals under statutes, regulations, orders, and decrees of various agencies of the United States government (collectively, “Trade Controls”); or (ii) have not engaged in any dealings or transactions with or for the benefit of any Sanctioned Person or in any Sanctioned Country.
(j) Neither the Company, nor any of its Subsidiaries, nor any of their respective officers, directors, Employees or, to the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries, has made, offered, promised or authorized any gift or payment of anything of value, directly or indirectly, to or for the benefit of any government officialNational City Subsidiary, or any other persondirector, in order to assist the Company in obtaining officer or retaining business employee of National City or otherwise securing any improper advantage in violation of applicable Anti-Corruption Laws.
(k) Neither the Company nor any of its Subsidiaries has received from any Governmental Entity or any Person any notice, inquiry, or internal or external allegation; made any voluntary or involuntary disclosure to a Governmental Entity; or conducted any internal investigation or audit concerning any actual or potential violation or wrongdoing in each case, related to Trade Controls or Anti-Corruption Laws.
(l) Since April 25, 2021 neither the Company nor its Subsidiaries or their respective affiliates or their employees, agents or contractors has entered into any arrangement involving the offering or paying any remuneration (including any kickback, bribe, discount or rebate), directly or indirectly, overtly or covertly in cash or in kind to any Person: (i) in return for referring an individual to the Company or any of its Subsidiaries for the furnishing or arranging for the furnishing of any itemNational City Subsidiary, product has committed any breach of trust or services for which payment may be made in whole or in part by any Health Care Program or commercial health insurer; or (ii) in return for purchasing, leasing or ordering or arranging for or recommending, purchasing, leasing or ordering any item, product, facility or service from or to the Company or any of its Subsidiaries for which payment may be made in whole or in part by any Health Care Program or commercial health insurer. There are no current arrangements relating to the Company or any of its Subsidiaries providing for any rebates, kickback or other forms of compensation that are unlawful to be paid to any Person in return for the referral or generation of business to the Company or any of its Subsidiaries or for the arrangement for recommendation of such referrals or business. Since April 25, 2021, the Company enters into written agreements with each of its independent contractor health care providers and sales and marketing personnel in compliance with the AKS Personal Services and Management Contracts safe harbor (as set forth at 42 C.F.R. § 1001.952 (d)).
(m) The Company and its Subsidiaries and affiliates are and since April 25, 2021 have been in material compliance with all applicable Healthcare Privacy and Security Laws. Since April 25, 2021, no Breach (as that term is defined in HIPAA) has occurred fiduciary duty with respect to any unsecured Protected Health Information (as such fiduciary account that term is defined in HIPAA) (“PHI”) maintained by reasonably likely to have, either individually or for the Company, any of its Subsidiaries and affiliates. Since April 25, 2021, the Company, its Subsidiaries and affiliates have not received any notice or complaint from any Person, including any Governmental Entity regarding the unauthorized processing of PHI or non-compliance with applicable Healthcare Privacy and Security Laws. Neither the Company, nor its Subsidiaries and their respective affiliates engage in the sale aggregate, a Material Adverse Effect, and, except as would not be reasonably likely to have, either individually or in the aggregate, a Material Adverse Effect, and the accountings for each such fiduciary account are true and correct and accurately reflect the assets of PHI, as the term “sale” is defined by applicable lawsuch fiduciary account.
Appears in 1 contract
Compliance with Laws and Orders. (a) The Company and its Subsidiaries each Company Subsidiary hold all licenses, franchises, permits and authorizations necessary for the lawful conduct of their respective businesses under and pursuant to each, and have complied in all respects with and are not in compliance and since April 25default in any respect under any, 2021 have been in compliance with all Laws (including all Health Care Laws) and Orders applicable law, statute, order, rule, regulation, policy or guideline of any Governmental Entity relating to the Company or any of its Subsidiaries or any assets owned or used by any of them (except for any such past noncompliance as has been remedied and imposes no continuing obligations or costs on the Company or its Subsidiaries)Subsidiary, except where any the failure to hold such non-compliancelicense, franchise, permit or authorization or such noncompliance or default is not reasonably likely to have, either individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect. Neither the Company nor any of its Subsidiaries has received any written communication since April 25, 2021, from any Governmental Entity that alleges that the Company or any of its Subsidiaries is not in compliance with any such Law or Order, except where any such non-compliance, individually or in the aggregate, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect.
(b) Since April 25, 2021, there has not been and currently there is no Proceeding pending against Except as disclosed in the Company or any of its Subsidiaries under any federal or state whistleblower statute, including under Reports filed by Company with the False Claims Act, 31 U.S.C. §§ 3729-3733 and Commission prior to the Knowledge date of this Agreement, the businesses of Company and each Company Subsidiary are not being conducted in violation of any law, ordinance, regulation, judgment, order, decree, license or permit of any Governmental Entity (including, without limitation, in the case of a Company Subsidiary that is a bank, all statutes, rules and regulations pertaining to the conduct of the Companybanking business and the exercise of trust powers), no such Proceeding has been threatenedexcept for violations which individually or in the aggregate do not, and, insofar as reasonably can be foreseen, in the future will not, have a Material Adverse Effect. Neither the Company nor any of its Subsidiaries is a party to No investigation or has any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed review by any Governmental Entity with respect to Company or any Health Care LawCompany Subsidiary is pending or, to the knowledge of Company threatened, nor has any Governmental Entity indicated an intention to conduct the same in each case other than those the outcome of which will not have a Material Adverse Effect.
(c) Neither the Company nor any of its Subsidiaries hasExcept as is not reasonably likely to have, since April 25, 2021, received or retained any payment in violation of applicable Health Care Laws or legally enforceable Health Care Program requirements (except for any such past violation as has been remedied and imposes no continuing obligations or costs on the Company or its Subsidiaries), except where any such violation, either individually or in the aggregate, a Material Adverse Effect, Company and each Company Subsidiary have properly administered all accounts for which its acts as a fiduciary, including accounts for which it serves as a trustee, agent, custodian, personal representative, guardian, conservator or investment advisor, in accordance with the terms of the governing documents, applicable state and federal law and regulation and common law. None of Company, any Company Subsidiary, or any director, officer or employee of Company or of any Company Subsidiary, has not had, and would not committed any breach of trust or fiduciary duty with respect to any such fiduciary account that is reasonably be expected likely to have, either individually or in the aggregate, a Company Material Adverse Effect.
(d) Since April 25, 2021, the Company and its Subsidiaries have not (i) had any product or manufacturing site (whether Company- or Subsidiary-owned) subject to a Governmental Entity (including the U.S. Food and Drug Administration (“FDA”)) shutdown or import or export prohibition, nor (ii) received any FDA Form 483 or other notice from a Governmental Entity of inspectional observations, notice of adverse finding, notice of violation, “warning letters,” “untitled letters” or requests or requirements to make changes to the products that if not complied with would reasonably be expected to have a Company Material Adverse Effect, and, to the Knowledge of the Company, no Governmental Entity has threatened any such action.
(e) The Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors have maintained and filed with the FDA and other Governmental Entities all material reports, data, documents, forms, notices, applications, records and claims that are necessary to comply in all material respects with applicable Health Care Laws. To the Knowledge of the Company, all such reports, data, documents, forms, notices, applications, records, claims, and other filings to the FDA and any similar Governmental Entity by the Company and its Subsidiaries, and their respective affiliates and their employees, agents, and contractors were true, accurate and complete in all material respects except as of the date made, and, to the extent required to be updated, have been updated to be true, accurate and complete in all material respects as of the date of such update.
(f) None of the Company and its Subsidiaries, or their respective affiliates or, to the Knowledge of the Company, their employees, agents, or contractors is the subject of any pending or, to the Knowledge of the Company, threatened Proceeding in respect of the Company, its Subsidiaries, or any Company Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto.
(g) None of the Company and its Subsidiaries, or their respective affiliates or their officers, employees, agents, or contractors has been suspended, excluded, debarred, or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. §§ 335(a)–(b) or any similar Law, (ii) exclusion under 42 U.S.C. § 1320a-7 in any federal or state health care program or any similar Law, (iii) prohibition from participating in any procurement program of or otherwise contracting with any Governmental Entity, or (iv) assessment of penalties under any Health Care Law, nor are any such advanced actions threatened or reasonably foreseeable. As of the date hereof, no Proceedings that would reasonably be expected to result in any such material debarment, exclusion, prohibition, or assessment of penalties are pending or, to the Knowledge of the Company, threatened against the Company, its Subsidiaries, or any of their respective affiliates or their officers, employees, agents, or contractors.
(h) The Company and its Subsidiaries, and their respective affiliates have in place an operational regulatory compliance program that governs all employees, agents, and contractors and that is designed to address compliance with all applicable Health Care Laws. The Company and its Subsidiaries, and their respective affiliates operate in compliance with such regulatory compliance program in all material respects, except where noncompliance has not had and would not be reasonably be expected likely to have have, either individually or in the aggregate, a Company Material Adverse Effect.
(i) Since April 25, 2021, the Company accountings for each such fiduciary account are true and each of its Subsidiaries, correct and each of their respective officers, directors, or Employees and, to accurately reflect the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries (i) have at all times been in material compliance with all Laws relating to export, reexport, transfer, and import control, economic and trade sanctions, and trade embargo statutes, regulations, decrees, orders, guidelines and policies of the United States government and the government of any country in which it conducts business including but not limited to the Export Administration Regulations (“EAR”) (15 C.F.R. Parts 730-774 (2022)) of the U.S. Department of Commerce; the U.S. antiboycott regulations and guidelines, including those under the EAR and U.S. Department of the Treasury regulations; the various economic sanctions regulations and guidelines of the U.S. Department of the Treasury, Office of Foreign Assets Control, and the USA Patriot Act (Title III of Pub. L. 107-56, signed into Law October 26, 2001), as amended; and restrictions against dealings with certain prohibited, debarred, denied or specially designated entities or individuals under statutes, regulations, orders, and decrees of various agencies of the United States government (collectively, “Trade Controls”); or (ii) have not engaged in any dealings or transactions with or for the benefit of any Sanctioned Person or in any Sanctioned Country.
(j) Neither the Company, nor any of its Subsidiaries, nor any of their respective officers, directors, Employees or, to the Knowledge of the Company, any agent or other third party representative acting on behalf of the Company or any of its Subsidiaries, has made, offered, promised or authorized any gift or payment of anything of value, directly or indirectly, to or for the benefit of any government official, or any other person, in order to assist the Company in obtaining or retaining business or otherwise securing any improper advantage in violation of applicable Anti-Corruption Laws.
(k) Neither the Company nor any of its Subsidiaries has received from any Governmental Entity or any Person any notice, inquiry, or internal or external allegation; made any voluntary or involuntary disclosure to a Governmental Entity; or conducted any internal investigation or audit concerning any actual or potential violation or wrongdoing in each case, related to Trade Controls or Anti-Corruption Laws.
(l) Since April 25, 2021 neither the Company nor its Subsidiaries or their respective affiliates or their employees, agents or contractors has entered into any arrangement involving the offering or paying any remuneration (including any kickback, bribe, discount or rebate), directly or indirectly, overtly or covertly in cash or in kind to any Person: (i) in return for referring an individual to the Company or any of its Subsidiaries for the furnishing or arranging for the furnishing of any item, product or services for which payment may be made in whole or in part by any Health Care Program or commercial health insurer; or (ii) in return for purchasing, leasing or ordering or arranging for or recommending, purchasing, leasing or ordering any item, product, facility or service from or to the Company or any of its Subsidiaries for which payment may be made in whole or in part by any Health Care Program or commercial health insurer. There are no current arrangements relating to the Company or any of its Subsidiaries providing for any rebates, kickback or other forms of compensation that are unlawful to be paid to any Person in return for the referral or generation of business to the Company or any of its Subsidiaries or for the arrangement for recommendation assets of such referrals or business. Since April 25, 2021, the Company enters into written agreements with each of its independent contractor health care providers and sales and marketing personnel in compliance with the AKS Personal Services and Management Contracts safe harbor (as set forth at 42 C.F.R. § 1001.952 (d))fiduciary account.
(m) The Company and its Subsidiaries and affiliates are and since April 25, 2021 have been in material compliance with all applicable Healthcare Privacy and Security Laws. Since April 25, 2021, no Breach (as that term is defined in HIPAA) has occurred with respect to any unsecured Protected Health Information (as that term is defined in HIPAA) (“PHI”) maintained by or for the Company, any of its Subsidiaries and affiliates. Since April 25, 2021, the Company, its Subsidiaries and affiliates have not received any notice or complaint from any Person, including any Governmental Entity regarding the unauthorized processing of PHI or non-compliance with applicable Healthcare Privacy and Security Laws. Neither the Company, nor its Subsidiaries and their respective affiliates engage in the sale of PHI, as the term “sale” is defined by applicable law.
Appears in 1 contract
