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Common use of Healthcare Regulatory Compliance Clause in Contracts

Healthcare Regulatory Compliance. (a) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and the Company Subsidiaries (taken as a whole), since January 1, 2020, the Company and each Company Subsidiary has been and, from January 1, 2020 through the date hereof, to the Company’s Knowledge, all Representatives (when acting on behalf of the Company or any Company Subsidiary) and suppliers (to the extent pertaining to the Company or any Company Subsidiary or any product or service provided to the Company or any Company Subsidiary), have been, in compliance with all applicable Healthcare Laws. Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and the Company Subsidiaries (taken as a whole), as of the date of this Agreement, there is no civil, criminal, administrative, or other action, subpoena, suit, demand, claim, hearing, Proceeding, written notice or demand pending, received by or, to the Knowledge of the Company, threatened against the Company or any Company Subsidiary related to such Healthcare Laws. (b) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and the Company Subsidiaries (taken as a whole), neither the Company nor any Company Subsidiary has engaged in an unlawful or unauthorized practice of medicine or other professionally licensed activities through any websites sponsored or operated, or formerly sponsored or operated, by the Company or any Company Subsidiary. (c) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and the Company Subsidiaries (taken as a whole), the Company has implemented a compliance program reasonably designed to ensure compliance with applicable Healthcare Laws and PhRMA and other industry codes and standards. (d) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and the Company Subsidiaries (taken as a whole), no Person has filed against the Company an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).

Appears in 3 contracts

Samples: Merger Agreement (Pfizer Inc), Merger Agreement (Seagen Inc.), Acquisition Agreement

Healthcare Regulatory Compliance. (a) Except as would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, the Company, the Company Subsidiaries, and to the Company’s Knowledge, its Third-Party Manufacturers are, and have been since December 31, 2014, in compliance with all Health Care Laws applicable to the Company, the Company Subsidiaries or their respective businesses as then or now conducted. Neither the Company nor any Company Subsidiary, or to the Company’s Knowledge, its Third-Party Manufacturers, have received any written notice from any person since December 31, 2014, alleging that the businesses of the Company, any of the Company Subsidiaries or its Third-Party Manufacturers have been conducted in default or violation of any applicable Health Care Law. There is no Order of any Governmental Body outstanding against the Company, the Company Subsidiaries or any of their assets that is or would reasonably be expected to be, individually or in the aggregate, material to the Company and or the Company Subsidiaries, or that in any manner challenges or seeks to prevent, enjoin, alter or materially impair or delay the Company’s ability to consummate the transactions contemplated hereby or otherwise perform any of its obligations hereunder. (b) The Company, the Company Subsidiaries (taken as a whole), since January 1, 2020, the Company and each Company Subsidiary has been and, from January 1, 2020 through the date hereof, to the Company’s Knowledge, its Third-Party Manufacturers, possess all Representatives (when acting on behalf of Governmental Authorizations, including those related to both establishments and the products researched, manufactured, distributed, and sold by the Company or any Company Subsidiary) and suppliers (to the extent pertaining to the Company or any Company Subsidiary or any product or service provided to Subsidiaries (collectively, “Permits”) necessary for their business and operations as currently conducted except for such Permits the Company or any Company Subsidiary)absence of which, have been, in compliance with all applicable Healthcare Laws. Except as would not have or reasonably be expected to behave, individually or in the aggregate, material to the a Company and Material Adverse Effect. The Company, the Company Subsidiaries (taken and, to the Company’s Knowledge, its Third-Party Manufacturers, are and have been since December 31, 2014, in compliance with the Permits and no condition exists that with notice or lapse of time or both would constitute a material default under, the Permits. To the Company’s Knowledge, none of the Permits will be terminated or impaired or become terminable or subject to consent, approval or reissuance by the applicable Governmental Body, in whole or in part, as a whole), as result of the date transactions contemplated hereby. (c) Without limiting the generality of this Agreement, there is no civil, criminal, administrative, or other actionthe foregoing, (i) Neither the Company nor any Company Subsidiary has received any written notice, subpoena, suitcomplaint or other non-ordinary course communication from any Governmental Body regarding any actual, demandalleged or potential violation of (or investigation with respect thereto) any Health Care Law or failure to comply with the terms or requirements of any Permit, claim, hearing, Proceeding, written notice or demand pending, received by or, to the Knowledge of the Company, threatened against the Company or any Company Subsidiary related to such Healthcare Laws. (b) Except except as would not have or reasonably be expected to behave, individually or in the aggregate, material a Company Material Adverse Effect. (ii) Except as set forth in Part 2.13(c)(ii) of the Disclosure Schedule, the Company, the Company Subsidiaries and/or any products manufactured by or for the Company or any of the Company Subsidiaries are not now subject (and have not been subject during the previous three (3) years) to any adverse inspection finding, investigation, penalty assessment, audit or other compliance or enforcement action, including but not limited to an untitled or warning letter, Form 483, adverse audit findings or similar communication, by the U.S. Food & Drug Administration (the “FDA”), or any other Governmental Body having responsibility for the regulation of the current and past business activities of the Company and the Company Subsidiaries, nor has the Company or any of the Company Subsidiaries received during the past three (3) years any written notice from any Governmental Body that it has commenced, or threatened to initiate an action to withdraw a product Permit or enjoin the sale of a product manufactured by the Company or any of the Company Subsidiaries and there are no field actions or recalls currently open or currently anticipated by the Company or the Company Subsidiaries for product Permits which it holds. The Company and the Company Subsidiaries have obtained all product Permits from the FDA and other Governmental Bodies for their respective businesses as now conducted. To the Company’s Knowledge, the Company and the Company Subsidiaries (taken as a whole), neither the Company nor have not made any Company Subsidiary has engaged false statements or false omissions in an unlawful or unauthorized practice of medicine any applications or other professionally licensed activities through any websites sponsored submissions to the FDA or operatedother authorities, or formerly sponsored or operated, by the Company or any Company Subsidiary. (c) Except as would not reasonably be expected to be, individually or in the aggregate, material to and the Company and the Company Subsidiaries (taken as a whole)have not made or offered any payments, gratuities or other things of value that are prohibited by any law or regulation to personnel of the Company has implemented a compliance program reasonably designed to ensure compliance with applicable Healthcare Laws and PhRMA and FDA or other industry codes and standardsGovernment Officials. (diii) Except No officer or employee of the Company or any of the Company Subsidiaries: (A) has been convicted of any crime or engaged in any conduct for which debarment is mandated or permitted by 21 U.S.C. § 335a; (B) has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act or any similar law; (C) has been convicted of or charged with any violation of any law related to any “Federal health care programs” as would not defined in 42 U.S.C. § 1320a-7b(f); (D) is excluded, suspended or debarred from participation, or is otherwise ineligible to participate, in any federal health care program or has committed any violation of law that is reasonably be expected to beserve as the basis for any such exclusion, individually suspension, debarment or other ineligibility; or (E) is or has been a party to a corporate integrity agreement, monitoring agreement, consent decree, settlement order or similar agreement with any Governmental Body related to any allegation that an operation or activity of the Company or any of the Company Subsidiaries is in violation of any applicable Health Care Law. (iv) All studies, tests and preclinical and clinical trials conducted by the aggregateCompany or the Company Subsidiaries since December 31, 2014 have been and are being conducted in material compliance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and applicable Health Care Laws and other applicable laws, rules, regulations and guidance, including, but not limited to the applicable requirements of Good Laboratory Practices or Good Clinical Practices, as applicable. The Company and the Company Subsidiaries have not received any written notices, correspondence or other communications from the FDA or any other Governmental Body (taken as a whole)including but not limited to any foreign or local authority, no Person has filed against institutional review board, or ethics committee) requiring the termination, suspension or material modification of any ongoing or planned clinical trials conducted by, or on behalf of, the Company an action relating or the Company Subsidiaries, and, to the Company under any federal or state whistleblower statuteCompany’s Knowledge, including under neither the False Claims Act FDA nor an analogous Governmental Body is considering such action. For the purposes of 1863 this Agreement, (31 U.S.C. § 3729 et seqA) “Good Clinical Practices” means the FDA’s standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in 21 C.F.R. Part 50, 54, 56, 312, 314, 320, 812, and 814 and foreign equivalents and (B) “Good Laboratory Practices” means the FDA’s standards for conducting non-clinical laboratory studies contained in 21 C.F.R. Part 58 and applicable foreign equivalents.).

Appears in 2 contracts

Samples: Merger Agreement (Rosetta Genomics Ltd.), Merger Agreement (Rosetta Genomics Ltd.)

Healthcare Regulatory Compliance. (a) Except as Since July 1, 2016, except where any failure to be in compliance has not been, and would not reasonably be expected to be, individually or in the aggregate, material materially adverse to the Company and the Company Subsidiaries (its Subsidiaries, taken as a whole), since January 1, 2020, the Company and each Company Subsidiary has its Subsidiaries have been andand are in compliance with (i) the Federal Ethics and Patient Referrals Act, from January 142 U.S.C. § 1395nn (known as the “Xxxxx Law”), 2020 through (ii) the date hereofFederal Health Care Program Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x) (known as the “Anti-Kickback Statute”), (iii) the Federal False Claims Act, 31 U.S.C. § 3729, (iv) the Occupational Safety and Health Act (known as “OSHA”), (v) the Clinical Laboratory Improvement Amendments, 42 C.F.R. Part 493 (“CLIA”), (vi) the Protecting Access to Medicare Act of 2014, (vii) federal and state anti-markup Laws, (viii) state self-referral, anti-kickback, fee-splitting and patient brokering Laws, (ix) state Laws governing the licensure and operation of clinical laboratories, and (x) to the Knowledge of the Company, similar Laws in any foreign jurisdiction applicable to the Company’s Knowledge, all Representatives and its Subsidiaries’ business (when acting on behalf of the Company or any Company Subsidiaryclauses (i) and suppliers through (to the extent pertaining to the Company or any Company Subsidiary or any product or service provided to the Company or any Company Subsidiaryx), have been, in compliance with all applicable Healthcare the “Regulatory Laws”). Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and the Company Subsidiaries (taken as a whole), as As of the date of this Agreement, there is no civil, criminal, administrative, or other action, subpoena, suit, demand, claim, hearing, Proceeding, written notice or demand pending, received by or, to the Knowledge of the Company, threatened against the business of the Company and its Subsidiaries does not require the Company or any Company Subsidiary related of its Subsidiaries to such Healthcare Lawsobtain any clearance or approval under the federal Food Drug and Cosmetic Act, 21 U.S.C. § 321 et seq. (b) Except as would not reasonably be expected to beFrom July 1, individually or in the aggregate, material 2016 to the Company and date of this Agreement, to the Company Subsidiaries (taken as a whole)Knowledge of the Company, neither the Company nor any Company Subsidiary of its Subsidiaries nor any of its or their respective officers, directors and employees, agents, subcontractors or affiliated entities in their capacities as such and in connection with the Company’s or its Subsidiaries’ business, (i) has engaged in an unlawful been charged with or unauthorized practice convicted of medicine or other professionally licensed activities through any websites sponsored or operated, or formerly sponsored or operated, by the Company or any Company Subsidiary. (c) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and the Company Subsidiaries (taken as a whole), the Company has implemented a compliance program reasonably designed to ensure compliance with applicable Healthcare Laws and PhRMA and other industry codes and standards. (d) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and the Company Subsidiaries (taken as a whole), no Person has filed against the Company an action criminal offense relating to the Company delivery of an item or service under any Federal Health Care Program, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, state contract or state medical assistance program, (iii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 00, Xxxxxxx 0, xx xxx Xxxxxx Xxxxxx Code (the “SSA”), (iv) is currently listed on any federal or state whistleblower statutepublished list or database of excluded parties, including under the False Claims Act U.S. General Services Administration published list of 1863 parties excluded from federal procurement programs and non-procurement programs, the HHS Office of Inspector General exclusions database and the National Practitioner Data Bank, or (31 U.S.C. § 3729 et seqv) is the target or subject of any current or potential investigation relating to any Federal Health Care Program-related offense. “Federal Health Care Program” has the meaning specified in Section 1128B(f) of the SSA and includes the Medicare, Medicaid and TRICARE programs.).

Appears in 2 contracts

Samples: Merger Agreement (Exact Sciences Corp), Merger Agreement (Genomic Health Inc)

Healthcare Regulatory Compliance. (a) Except as would not have or reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, the Company, its Subsidiaries, and to the knowledge of the Company, its Third Party Manufacturers are, and have been since January 1, 2015, in compliance with all Health Care Law applicable to the Company, its Subsidiaries or their respective businesses as then or now conducted. Neither the Company or its Subsidiaries, nor to the knowledge of the Company, its Third Party Manufacturers, have received any written notice from any person since January 1, 2015, alleging that the businesses of the Company, any of its Subsidiaries or its Third Party Manufacturers have been conducted in default or violation of any applicable Health Care Law. There is no order of any Governmental Entity outstanding against the Company, its Subsidiaries or any of their assets that is or would reasonably be expected to be, individually or in the aggregate, material to the Company or its Subsidiaries, or that in any manner challenges or seeks to prevent, enjoin, alter or materially impair or delay the Company’s ability to consummate the transactions contemplated hereby or otherwise perform any of its obligations hereunder. (b) The Company, its Subsidiaries and, to the knowledge of the Company, its Third Party Manufacturers, possess all permits, licenses, approvals, clearances, certifications, registrations, listings and authorizations from any Governmental Entity, including those related to both establishments and the products researched, manufactured, distributed, and sold by the Company or its Subsidiaries (taken collectively, “Permits”) necessary for their business and operations as currently conducted except for such Permits the absence of which, would not have or reasonably be expected to have individually or in the aggregate, a whole)Material Adverse Effect. The Company, its Subsidiaries and, to the knowledge of the Company, its Third Party Manufacturers, are and have been since January 1, 2020, the Company and each Company Subsidiary has been and, from January 1, 2020 through the date hereof, to the Company’s Knowledge, all Representatives (when acting on behalf of the Company or any Company Subsidiary) and suppliers (to the extent pertaining to the Company or any Company Subsidiary or any product or service provided to the Company or any Company Subsidiary), have been2015, in compliance with all the Permits and no condition exists that with notice or lapse of time or both would constitute a material default under, the Permits. To the Company’s knowledge, none of the Permits will be terminated or impaired or become terminable or subject to consent, approval or reissuance by the applicable Healthcare Laws. Except Governmental Entity, in whole or in part, as a result of the transactions contemplated hereby. (c) Without limiting the generality of the foregoing, (i) Neither the Company nor any of its Subsidiaries have received any written notice, subpoena, complaint or other non-ordinary course communication from any Governmental Entity regarding any actual, alleged, or potential violation of (or investigation with respect thereto) any Health Care Law or failure to comply with the terms or requirements of any Permit, except as would not have or reasonably be expected to behave, individually or in the aggregate, material to a Material Adverse Effect. (ii) Except as set forth in Section 3.17(c)(ii) of the Company and the Company Subsidiaries (taken as a whole)Disclosure Schedule, as of the date of this Agreement, there is no civil, criminal, administrative, or other action, subpoena, suit, demand, claim, hearing, Proceeding, written notice or demand pending, received by or, to the Knowledge of the Company, threatened against its Subsidiaries and/or any products manufactured by or for the Company or any Company Subsidiary related of its Subsidiaries are not now subject (and have not been subject during the previous three (3) years) to such Healthcare Laws. any adverse inspection finding, investigation, penalty assessment, audit or other compliance or enforcement action, including but not limited to an untitled or warning letter, Form 483, adverse audit findings or similar communication, by the U.S. Food & Drug Administration (b) Except as would not reasonably be expected to bethe “FDA”), individually an EU notified body, the Chinese Food and Drug Administration, Health Canada, the Therapeutic Goods Administration, the Japanese Ministry of Health, Labor, and Welfare, or in any other Governmental Entity having responsibility for the aggregate, material to regulation of the current and past business activities of the Company and its Subsidiaries, nor has the Company or any of its Subsidiaries received during the past three (taken as a whole), neither the Company nor 3) years any Company Subsidiary written notice from any Governmental Entity that it has engaged in an unlawful or unauthorized practice of medicine or other professionally licensed activities through any websites sponsored or operatedcommenced, or formerly sponsored threatened to initiate an action to withdraw a product Permit or operated, enjoin the sale of a product manufactured by the Company or any of its Subsidiaries and there are no field actions or recalls currently open or currently anticipated by the Company Subsidiaryor its Subsidiaries for product Permits which it holds. The Company and its Subsidiaries have obtained all product Permits from the FDA and other Governmental Entities for their respective businesses as now conducted. To the knowledge of the Company, the Company and its Subsidiaries have not made any material false statements or material false omissions in any applications or other submissions to the FDA or other authorities and the Company and its Subsidiaries have not made or offered any payments, gratuities or other things of value that are prohibited by any law or regulation to personnel of the FDA or other Government Officials. (ciii) Except No officer or employee of the Company or any of its Subsidiaries (i) has been convicted of any crime or engaged in any conduct for which debarment is mandated or permitted by 21 U.S.C. § 335a; (ii) has been convicted of any crime or engaged in any conduct for which such person or entity could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act or any similar law; (iii) has been convicted of or charged with any violation of any law related to any “Federal health care programs” as would not defined in 42 U.S.C. § 1320a-7b(f); (iv) is excluded, suspended or debarred from participation, or is otherwise ineligible to participate, in any federal health care program or has committed any violation of law that is reasonably be expected to beserve as the basis for any such exclusion, individually suspension, debarment or other ineligibility or (v) is or has been a party to a corporate integrity agreement, monitoring agreement, consent decree, settlement order or similar agreement with any Governmental Entity related to any allegation that an operation or activity of the Company or any of its Subsidiaries is in violation of any applicable Health Care Law. (iv) All studies, tests and preclinical and clinical trials conducted by the aggregateCompany or its Subsidiaries since January 1, 2015 have been and are being conducted in material compliance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and applicable Health Care Laws and other applicable laws, rules, regulations and guidance, including, but not limited to the applicable requirements of Good Laboratory Practices or Good Clinical Practices, as applicable. The Company and its Subsidiaries have not received any written notices, correspondence or other communication from the Company Subsidiaries FDA or other Governmental Entity (taken as a whole)including but not limited to any foreign or local authority, institutional review board, or ethics committee) requiring the termination, suspension or material modification of any ongoing or planned clinical trials conducted by, or on behalf of, the Company has implemented a compliance program reasonably designed to ensure compliance with applicable Healthcare Laws and PhRMA and other industry codes and standards. (d) Except as would not reasonably be expected to beor its Subsidiaries, individually or in the aggregateand, material to the Company knowledge of the Company, neither the FDA nor an analogous Governmental Entity is considering such action. For the purposes of this Agreement, (i) “Good Clinical Practices” means the FDA’s standards for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials contained in 21 C.F.R. Part 50, 54, 56, 312, 314, 320, 812, and 814 and foreign equivalents and (ii) “Good Laboratory Practices” means the Company Subsidiaries (taken as a whole), no Person has filed against the Company an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seqFDA’s standards for conducting non-clinical laboratory studies contained in 21 C.F.R. Part 58 and applicable foreign equivalents.).

Appears in 1 contract

Samples: Merger Agreement (Syneron Medical Ltd.)

Healthcare Regulatory Compliance. (a) Except as The Company and each Subsidiary is, and since January 31, 2017 has been, in compliance with all Healthcare Laws applicable to it and its assets, business or operations, except where such non-compliance would not reasonably be expected to be, individually or in the aggregate, material to the Company and the Company Subsidiaries (its Subsidiaries, taken as a whole), since January 1, 2020, the Company and each Company Subsidiary has been and, from January 1, 2020 through the date hereof. There are no written claims or notices of violation pending or, to the Company’s Knowledge, all Representatives (when acting on behalf of threatened in writing against the Company or any Company Subsidiary) and suppliers (of its Subsidiaries alleging material violations of or liability under any Healthcare Laws or Healthcare Permits, and, to the extent pertaining Company’s Knowledge, neither the Company nor any Subsidiary is under or has been under, any non-routine audit or investigation by a Governmental Authority alleging material non-compliance by the Company or such Subsidiary with respect to any Healthcare Laws. (b) The Company and each of its Subsidiaries holds in full force and effect all Healthcare Permits necessary for it to own, lease, sublease or operate its assets under applicable Healthcare Laws or to conduct its business and operations as presently conducted except where the failure to hold any such Healthcare Permit would not, individually or in the aggregate, reasonably be expected to be material to the Company and its Subsidiaries, taken as a whole. To the Company’s Knowledge, no circumstance exists or event has occurred which would reasonably be expected to result in the suspension, revocation, termination, restriction, limitation, modification or non-renewal of any Healthcare Permit held by the Company or any Company Subsidiary of its Subsidiaries, except where such suspension, revocation, termination, restriction, limitation, modification or any product or service provided to the Company or any Company Subsidiary), have been, in compliance with all applicable Healthcare Laws. Except as non-renewal would not reasonably be expected to be, individually or in the aggregate, material to the Company and the Company Subsidiaries (its Subsidiaries, taken as a whole), . (c) To the Company’s Knowledge as of the date of this Agreementhereof, there is no civil, criminal, administrativethe Healthcare Professionals employed by, or other actionunder contract with, subpoena, suit, demand, claim, hearing, Proceeding, written notice or demand pending, received by or, to the Knowledge of the Company, threatened against the Company or any Company Subsidiary related have complied and currently are in compliance with all applicable Healthcare Laws, and hold and have held all Healthcare Permits required to be held by them in the performance of their duties, and such Healthcare Laws. (b) Except as Permits have not been suspended, revoked, or restricted in any manner, and are all of the Healthcare Permits that are required for such Person to perform his or her duties for the Company, except where non-compliance with applicable Healthcare Laws or a failure to have a Healthcare Permit would not reasonably be expected to be, individually or in the aggregate, material to the Company and the Company Subsidiaries (its Subsidiaries, taken as a whole. The Company and its Subsidiaries have commercially reasonable systems and policies in place to verify and monitor the continued eligibility of all Healthcare Professionals employed by, or under contract with, the Company or such Subsidiary. (d) Since January 31, 2017, neither the Company nor any of its Subsidiaries, nor to the Company’s Knowledge as of the date hereof, any officer or employee of the Company or any Subsidiary has (i) offered or paid or solicited or received any remuneration, in cash or in kind, or made any financial arrangements, in violation of any applicable Healthcare Law; (ii) given any gift or gratuitous payment of any kind, nature or description (whether in money, property or services) in violation of any applicable Healthcare Law; (iii) made any contribution, payment or gift of funds or property to, or for the private use of, any governmental official, employee or agent where either the contribution, payment or gift or the purpose of such contribution, payment or gift was illegal in any respect under the applicable Legal Requirements of any Governmental Authority having jurisdiction over such payment, contribution or gift; (iv) established or maintained any unrecorded fund or asset or made any misleading, false or artificial entries on any of its books or records in violation of applicable Healthcare Laws; or (v) made any payment to any person with the intention that any part of such payment would be in violation of any applicable Healthcare Law. To the Company’s Knowledge, no Person has filed or has threatened in writing to file against the Company or any Subsidiary an action under any federal or state whistleblower statute related to alleged noncompliance with applicable Healthcare Laws, including under the False Claims Act of 1863 (31 U.S.C. 6 3729 et seq.). (e) Schedule 2.27(e) lists all National Provider Identifiers and provider numbers for the Company and each Subsidiary and Associated Person that participates in any Federal Healthcare Program. Since January 31, 2017, neither the Company nor any Subsidiary, nor to the Company’s Knowledge, any Associated Person, has (i) been excluded from participating in any Federal Healthcare Program or any similar law, whether pursuant to 21 U.S.C. 335a, or similar state or foreign law, or otherwise; (ii) had a civil monetary penalty assessed pursuant to 42 U.S.C. § 1320a-7 or Section 1128A of the Social Security Act; (iii) been convicted (as that term is defined in 42 C.F.R. 61001.2) of any of those offenses described in 42 U.S.C. §1320a-7b or 18 U.S.C. 11669, 1035. 1347 or 1518, including any of the following categories of offenses: (A) criminal offenses relating to the delivery of an item or service under any Federal Healthcare Program (as that term is defined in 42 U.S.C. §1320a-7b) or healthcare benefit program (as that term is defined in 18 U.S.C. 124b), (B) criminal offenses under federal or state Law relating to patient neglect or abuse in connection with the delivery of a healthcare item or service, (C) criminal offenses under Laws relating to fraud and abuse, theft, embezzlement, false statements to third parties, money laundering, kickbacks, breach of fiduciary responsibility or other financial misconduct in connection with the delivery of a healthcare item or service or with respect to any act or omission in a program operated by or financed in whole or in part by any federal, state or local governmental agency, (D) violations of Laws relating to the interference with or obstruction of any investigations into any criminal offenses described in this Section 2.27(e), or (E) criminal offenses under Laws relating to the unlawful manufacturing, distribution, prescription or dispensing of a controlled substance; or (iv) been involved or named in a U.S. Attorney complaint made or any other action taken pursuant to the False Claims Act under 31 U.S.C. §13729-3731 or qui tam action brought pursuant to 31 U.S.C. 63729 et seq. (f) Except as set forth in Schedule 2.27(f), neither the Company nor any Company Subsidiary has engaged in an unlawful of its Subsidiaries, nor to the Company’s Knowledge, any officer or unauthorized practice employee of medicine or other professionally licensed activities through any websites sponsored or operated, or formerly sponsored or operated, by the Company or any Company Subsidiary, is a party to or bound by any individual integrity agreement, corporate integrity agreement, corporate compliance agreement, deferred prosecution agreement, or other formal agreement with any Governmental Authority concerning compliance with Healthcare Laws, any Federal Healthcare Program, or the requirements of any Healthcare Permit. (cg) Except as set forth in Schedule 2.27(g), since January 31, 2017, the Company and its Subsidiaries have timely filed all material regulatory reports, schedules, statements, documents, filings, submissions, forms, registrations and other documents, together with any amendments required to be made with respect thereto, that each was required to file with any Governmental Authority, including state health and insurance regulatory authorities and any applicable federal regulatory authorities, except where such failure to timely file would not reasonably be expected to be, individually or in the aggregate, material to the Company and the Company Subsidiaries (its Subsidiaries, taken as a whole), the Company has implemented a compliance program reasonably designed to ensure compliance . All such regulatory filings complied in all material respects with applicable Healthcare Laws and PhRMA and other industry codes and standards. (d) Except as Laws, except where such non-compliance would not reasonably be expected to be, individually or in the aggregate, material to the Company and the Company Subsidiaries (its Subsidiaries, taken as a whole. (h) Since January 31, 2017, the Company and its Subsidiaries have (i) timely filed all material reports and xxxxxxxx required to be filed with each Customer, all of which were prepared in material compliance with all applicable Laws governing reimbursement and claims and the binding payment policies of the applicable Customer to which such Person is bound, (ii) paid all known and undisputed material refunds, overpayments, discounts and adjustments required to be paid, and there is no pending or, to the Company’s Knowledge, threatened in writing, material appeal, adjustment, challenge, adverse inquiry, audit (including written notice of an intent to audit), no Person has filed against the Company an action relating or litigation by any Customer with respect to the Company under or any federal Subsidiary’s billing practices and reimbursement claims (other than routine audits in the ordinary course of business) and (iii) never been subject to a material audit (or state whistleblower statute, including under received written notice that it is subject to a material audit) other than in the False Claims Act ordinary course of 1863 (31 U.S.C. § 3729 et seqbusiness. The Company has implemented commercially reasonable billing policies and practices to comply in all material respects with all applicable Healthcare Laws.).

Appears in 1 contract

Samples: Merger Agreement (Motion Acquisition Corp.)

Healthcare Regulatory Compliance. (a) Except as would not reasonably be expected Each of the Group Companies is, and for the past four (4) years has been, in compliance with all Healthcare Laws applicable to beit and its assets, business or operations, except to the extent that any noncompliance, individually or in the aggregate, would not reasonably be expected to be material to the Company and the Company Subsidiaries (taken as a whole), since January 1, 2020, the Company and each Company Subsidiary has been and, from January 1, 2020 through the date hereofGroup Companies. There are no written claims or notices of violation pending or, to the Company’s Knowledge, all Representatives (when acting on behalf Knowledge of the Company (and after the Reorganization, Newco), threatened in writing against any of the Group Companies alleging violations of or liability under any Healthcare Laws or Healthcare Permits, except for any such claim or notice that would not reasonably be expected to be material to the Group Companies. Each of the Group Companies holds in full force and effect all Healthcare Permits necessary for it to own, lease, sublease or operate its assets under applicable Healthcare Laws or to conduct its business and operations as presently conducted except where the failure to hold such Healthcare Permits would not reasonably be expected to be material to the Group Companies. There exist no required plans of correction or other such remedial measures with respect to (i) any Healthcare Permit of any of the Group Companies that would reasonably be expected to be material to the Group Companies. To the Knowledge of the Company Subsidiary(and after the Reorganization, Newco), no circumstance exists or event has occurred which would reasonably be expected to result in the suspension, revocation, termination, restriction, limitation, modification or non-renewal of any material Healthcare Permit held by any of the Group Companies. (b) To the Knowledge of the Company (and after the Reorganization, Newco) and suppliers (solely as related to the extent pertaining to operations of the Company Group Companies, the Healthcare Professionals employed by, or any Company Subsidiary or any product or service provided to under contract with, the Company or any Company Subsidiary), Group Companies have been, complied and currently are in compliance with all applicable Healthcare Laws, and hold and have held all material professional licenses and other Healthcare Permits required to be held by them in the performance of their duties. Except as The Group Companies have appropriate systems and policies in place to verify and monitor the continued eligibility of all Healthcare Professionals employed by, or under contract with, the Group Companies. (c) None of the Group Companies, nor to the Knowledge of the Company (and after the Reorganization, Newco), any officer, or employee of any of the Group Companies, has made an untrue statement of a material fact or fraudulent statement to any Governmental Entity, failed to disclose a material fact that must be disclosed to any Governmental Entity, or committed an act, made a statement or failed to make a statement that, at the time such statement, disclosure or failure to disclose occurred, would not constitute a violation of any Healthcare Law that would reasonably be expected to bebe material to the Group Companies. (d) None of the Group Companies has received written notice of, or has knowledge of, any overpayment or refunds due to any Third Party Payor Program, except where such overpayment or refund would not, either individually or in the aggregate, reasonably be expected to be material to the Group Companies. (e) None of the Group Companies, nor to the Knowledge of the Company (and after the Reorganization, Newco), any officer or managing employee of any of the Group Companies has (i) offered or paid or solicited or received any remuneration, in cash or in kind, or made any financial arrangements, in violation of any applicable Healthcare Law; (ii) given any gift or gratuitous payment of any kind, nature or description (whether in money, property or services) in violation of any applicable Healthcare Law; (iii) made any contribution, payment or gift of funds or property to, or for the private use of, any governmental official, employee or agent where either the contribution, payment or gift or the purpose of such contribution, payment or gift was illegal in any respect under the applicable Laws of any Governmental Entity having jurisdiction over such payment, contribution or gift; (iv) established or maintained any unrecorded fund or asset or made any misleading, false or artificial entries on any of its books or records in violation of applicable Healthcare Laws; or (v) made any payment to any person with the intention that any part of such payment would be in violation of any applicable Healthcare Law, in each case, except to the extent that any noncompliance would not, individually or in the aggregate, reasonably be expected to be material to the Company and the Company Subsidiaries (taken as a whole), as of the date of this Agreement, there is no civil, criminal, administrative, or other action, subpoena, suit, demand, claim, hearing, Proceeding, written notice or demand pending, received by or, to Group Companies. To the Knowledge of the CompanyCompany (and after the Reorganization, threatened against the Company or any Company Subsidiary related to such Healthcare Laws. (b) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and the Company Subsidiaries (taken as a whole), neither the Company nor any Company Subsidiary has engaged in an unlawful or unauthorized practice of medicine or other professionally licensed activities through any websites sponsored or operated, or formerly sponsored or operated, by the Company or any Company Subsidiary. (c) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and the Company Subsidiaries (taken as a whole), the Company has implemented a compliance program reasonably designed to ensure compliance with applicable Healthcare Laws and PhRMA and other industry codes and standards. (d) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and the Company Subsidiaries (taken as a wholeNewco), no Person has filed or has threatened in writing to file against any of the Company Group Companies an action relating to the Company under any federal or state whistleblower statutestatute related to alleged noncompliance with applicable Healthcare Laws, including under the False Claims Act of 1863 (31 U.S.C. § 6 3729 et seq.). (f) None of the Group Companies, nor to the Knowledge of the Company (and after the Reorganization, Newco), any owner, officer, director or managing employee or Person with a “direct or indirect ownership interest” (as that phrase is defined in 42 C.F.R. § 420.201) in any of the Group Companies, has (i) been excluded from participating in any Federal Healthcare Program or any similar law; (ii) had a civil monetary penalty assessed pursuant to 42 U.S.C. § 1320a-7; (iii) been convicted (as that term is defined in 42 C.F.R. 61001.2) of any of those offenses described in 42 U.S.C. §1320a-7b or 18 U.S.C. 11669, 1035. 1347 or 1518, including any of the following categories of offenses: (A) criminal offenses relating to the delivery of an item or service under any Federal Healthcare Program (as that term is defined in 42 U.S.C. §1320a-7b) or healthcare benefit program (as that term is defined in 18 U.S.C. 124b), (B) criminal offenses under federal or state Law relating to patient neglect or abuse in connection with the delivery of a healthcare item or service, (C) criminal offenses under Laws relating to fraud and abuse, theft, embezzlement, false statements to third parties, money laundering, kickbacks, breach of fiduciary responsibility or other financial misconduct in connection with the delivery of a healthcare item or service or with respect to any act or omission in a program operated by or financed in whole or in part by any federal, state or local governmental agency, (D) violations of Laws relating to the interference with or obstruction of any investigations into any criminal offenses described in this Section 4.25(f), or (E) criminal offenses under Laws relating to the unlawful manufacturing, distribution, prescription or dispensing of a controlled substance; or (iv) been involved or named in a U.S. Attorney complaint made or any other action taken pursuant to the False Claims Act under 31 U.S.C. §13729-3731 or qui tam action brought pursuant to 31 U.S.C. 63729 et seq. (g) None of the Group Companies, nor, to the Knowledge of the Company (and after the Reorganization, Newco), any owner, officer, director or managing employee of any of the Group Companies, is a party to or bound by any individual integrity agreement, corporate integrity agreement, corporate compliance agreement, deferred prosecution agreement, or other formal agreement with any Governmental Entity concerning compliance with Healthcare Laws, any Federal Healthcare Program, or the requirements of any Healthcare Permit. (h) Each of the Group Companies is, and for the past four (4) years has been, in compliance in all material respects with HIPAA and Other Privacy Laws. None of the Group Companies within the past four (4) years, suffered any breach requiring any notification to any individual, entity, the media or any Governmental Entity, received any written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Entity regarding any allegation regarding its failure to comply with HIPAA and Other Privacy Laws, nor made any notification of such a breach or failure to any individual or entity, the media, the Secretary of the U.S. Department of Health and Human Services or any other Governmental Entity pursuant to HIPAA and Other Privacy Laws.

Appears in 1 contract

Samples: Merger Agreement (Healthcare Merger Corp.)