Compliance with Healthcare Laws. (a) The Company and each of its Subsidiaries are, and have been since January 1, 2021, in compliance with all applicable Healthcare Laws and Third-Party Payor Program rules, except as would not, individually or in the aggregate, have a Material Adverse Effect. Except as would not, individually or in the aggregate, have a Material Adverse Effect, no Action has been filed, commenced or, to the Company’s Knowledge, threatened against the Company or its Subsidiaries alleging any failure to comply with any Healthcare Law and neither the Company nor any of its Subsidiaries has received written notice from any Governmental Authority relating to any actual or alleged violation of, default under, noncompliance with, or complaint to or investigation or inquiry or non-routine audit by any Governmental Authority with respect to, any Healthcare Laws. Except as would not, individually or in the aggregate, have a Material Adverse Effect, neither the Company nor any of its Subsidiaries has received written notice from any Governmental Authority of, and to the Company’s Knowledge there are no, pending, active or threatened Actions, complaints, investigations, audits or inquiries pertaining to the Company or any of its Subsidiaries with respect to any Healthcare Laws prohibiting, governing, regulating or relating to fee-splitting, self-referrals or payment or receipt of kickbacks in return for or to induce referrals. (b) Except as would not, individually or in the aggregate, have a Material Adverse Effect, since January 1, 2021, the Company and its Subsidiaries have not billed or received, or caused a customer pharmacy to bill or receive, any payment or reimbursement from a Third-Party Payor Program in excess of amounts allowed by Law, other than as adjusted in the ordinary course of business or in connection with any routine audit or post-payment review by such that is resolved in compliance with applicable Healthcare Laws or Third-Party Payor Program. (c) Except as would not, individually or in the aggregate, have a Material Adverse Effect, since January 1, 2021, none of the Company, its Subsidiaries, any of its or their respective officers, directors or employees or, to the Knowledge of the Company, any of its or their respective contractors, agents or other representatives: (i) has been convicted of, charged with or entered into any settlement agreement with any Governmental Authority to avoid conviction of, any violation of any Healthcare Laws; (ii) has been excluded, suspended, debarred or proposed for debarment from participation, has received a written notice of their exclusion, suspension or debarment from participation, has been threatened in writing with exclusion, suspension or debarment from participation or is otherwise ineligible to participate in Third-Party Payor Programs; or (iii) has been convicted of, or entered into any settlement agreement with any Governmental Authority to avoid conviction of, any criminal offense relating to the delivery of any item or service under a Third-Party Payor Program or had a civil monetary penalty assessed against them under Section 1128A of the Social Security Act or any regulations promulgated thereunder, in the case of each of clauses (i) through (iii), related to the Company’s and its Subsidiaries’ businesses. (d) The Company and/or its Subsidiaries (as applicable) (i) meet the requirements for participation in the provision of services to, and the receipt of payment from, the respective Third-Party Payor Programs in which they participate and (ii) are party to one or more valid agreements with Third-Party Payor Programs authorizing such participation and are in material compliance with the terms of such agreements. Neither the Company nor any of its Subsidiaries has, for itself or for any third party, submitted or caused to be submitted to a Governmental Authority a knowingly false or knowingly fraudulent claim for payment. (e) None of the Company, its Subsidiaries, any of its or their respective officers, directors, or employees or, to the Knowledge of the Company, any of its or their respective contractors, agents or other representatives is, and none has been since January 1, 2021, a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement, or other formal or informal agreement with any Governmental Authority concerning alleged noncompliance with Healthcare Laws. (f) The Company has adopted and implemented compliance policies that are designed to address the requirements of Healthcare Laws and have been structured in light of the guidance promulgated by the U.S. Department of Health and Human Services, Office of Inspector General on what constitutes an effective compliance program.
Appears in 2 contracts
Samples: Merger Agreement (Tabula Rasa HealthCare, Inc.), Merger Agreement (Tabula Rasa HealthCare, Inc.)
Compliance with Healthcare Laws. (a) The Company and each 4.19.1 Except as set forth on Section 4.19.1 of its Subsidiaries arethe Disclosure Schedules, the Business is, and have at all times during the three (3) year period prior to the Closing, has been since January 1, 2021, in compliance in all material respects with all applicable Healthcare Laws and Third-Party Payor Program rules, except as would not, individually or in the aggregate, have a Material Adverse Effect. Except as would not, individually or in set forth on Section 4.19.1 of the aggregate, have a Material Adverse EffectDisclosure Schedules, no Action has been filed, commenced or, to the CompanySeller’s Knowledge, threatened against the Company or its Subsidiaries Seller alleging any failure of the Business so to comply with any Healthcare Law in any respect, and neither the Company Seller nor any of its Subsidiaries the Business has received any written notice from any Governmental Authority Body or agent thereof of relating to any actual or alleged violation of, default under, noncompliance with, or complaint to or investigation or inquiry or non-routine audit by any Governmental Authority Body respect to the Business with respect to, any Healthcare Laws. Except as set forth on Section 4.19.1 of the Disclosure Schedules, to the Seller’s Knowledge, no facts, events, circumstances or conditions exist that would notreasonably be expected to form the basis for any Action, individually complaint, investigation, audit or in inquiry against or affecting the aggregateBusiness or the operation thereof relating to or arising under any Healthcare Law. Except as set forth on Section 4.19.1 of the Disclosure Schedules, have a Material Adverse Effect, neither the Company nor Seller has not received any of its Subsidiaries has received written notice from any Governmental Authority ofBody, and to the Company’s Knowledge there are no, Seller is not aware of any pending, active or threatened Actions, complaints, investigations, audits or inquiries pertaining to the Company or any of its Subsidiaries Business with respect to any Healthcare Laws prohibiting, governing, regulating or relating to fee-splitting, self-referrals or payment or receipt of kickbacks in return for or to induce referrals. The Seller and the Business have implemented and maintain policies and procedures that comply with Healthcare Laws.
4.19.2 During the past three (b3) Except as would notyears, individually or in neither Seller, nor, to the aggregate, have a Material Adverse Effect, since January 1, 2021Seller’s Knowledge, the Company and its Subsidiaries Business Employees have (i) been reprimanded, debarred, disqualified, sanctioned, excluded or disciplined by any licensing board, Governmental Body or any other body, professional society, hospital, or Third-Party Payor Program, (ii) had a judgment or settlement without judgment entered against it, him or her in connection with a malpractice or similar action, (iii) been found liable or responsible for any civil offense reasonably related to qualifications or competence relating to professional practice or (iv) been terminated from employment for cause related to any of the actions described in this Section 4.19.2.
4.19.3 The Business has not billed or received, or caused a customer pharmacy to bill bxxx or receive, any payment or reimbursement from a Third-Party Payor Program in excess of amounts allowed by Law, other than as adjusted in the ordinary course of business or in connection with any routine audit or post-payment review by such that is resolved in compliance with applicable Healthcare Laws or Third-Party Payor Program.
4.19.4 During the past three (c3) Except as would not, individually or in the aggregate, have a Material Adverse Effect, since January 1, 2021years, none of the Company, its Subsidiaries, Business or Seller or any of its or their respective current or former officers, directors or employees ordirectors, to the Knowledge of the Companyemployees, any of its or their respective contractors, agents or other representatives: (i) has been convicted of, charged with or entered into any settlement agreement with any Governmental Authority Body to avoid conviction of, any violation of any Healthcare Laws; (ii) has been excluded, suspended, debarred or proposed for debarment from participation, has received a written notice of their exclusion, suspension or debarment from participation, has been threatened in writing with exclusion, suspension or debarment from participation or is otherwise ineligible to participate in Third-Party Payor Programs; or (iii) has been convicted of, or entered into any settlement agreement with any Governmental Authority Body to avoid conviction of, any criminal offense relating to the delivery of any item or service under a Third-Party Payor Program or had a civil monetary penalty assessed against them under Section 1128A of the Social Security Act or any regulations promulgated thereunder, in the case of each of clauses (i) through (iii), related to the Company’s and its Subsidiaries’ businessesBusiness.
(d) The Company and/or its Subsidiaries (as applicable) (i) meet the requirements for participation in the provision of services to, and the receipt of payment from, the respective Third-Party Payor Programs in which they participate and (ii) are party to one or more valid agreements with Third-Party Payor Programs authorizing such participation and are in material compliance with the terms of such agreements. Neither the Company nor any of its Subsidiaries has, for itself or for any third party, submitted or caused to be submitted to a Governmental Authority a knowingly false or knowingly fraudulent claim for payment.
(e) None of the Company, its Subsidiaries, any of its or their respective officers, directors, or employees or, to the Knowledge of the Company, any of its or their respective contractors, agents or other representatives is, and none has been since January 1, 2021, a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement, or other formal or informal agreement with any Governmental Authority concerning alleged noncompliance with Healthcare Laws.
(f) The Company has adopted and implemented compliance policies that are designed to address the requirements of Healthcare Laws and have been structured in light of the guidance promulgated by the U.S. Department of Health and Human Services, Office of Inspector General on what constitutes an effective compliance program.
Appears in 1 contract
Samples: Asset Purchase Agreement (Tabula Rasa HealthCare, Inc.)
Compliance with Healthcare Laws. (a) The Except as set forth on Schedule 3.27(a), the Company and each of its Subsidiaries are, and have at all times during the six (6)-year period prior to the Closing, has been since January 1, 2021, in compliance in all material respects with all applicable Healthcare Laws and Third-Party Payor Program rules, except as would not, individually or in the aggregate, have a Material Adverse EffectLaws. Except as would not, individually or in the aggregate, have a Material Adverse Effect, no No Action has been filed, commenced or, to the Company’s Knowledge, or threatened against the Company or its Subsidiaries alleging any failure so to comply with any Healthcare Law in any respect, and neither the Company nor any of and its Subsidiaries has have not received any written notice from any Governmental Authority relating to or agent thereof of any actual or alleged violation of, default under, under or any citation for noncompliance with, or complaint to or investigation or inquiry or non-routine audit by any Governmental Authority with respect to, any Healthcare Laws. Except as set forth on Schedule 3.27(a), to the Company’s knowledge, no facts, events, circumstances or conditions exist that would not, individually reasonably be expected to form the basis for any Action against or in the aggregate, have a Material Adverse Effect, neither affecting the Company nor any of or its Subsidiaries has relating to or arising under any Healthcare Law. Except as set forth on Schedule 3.27(a), the Company and its Subsidiaries have not received any written notice from any Governmental Authority of, and to the Company’s Knowledge there or are no, aware of any pending, active or threatened Actions, complaints, investigations, audits or inquiries Actions pertaining to the Company or any of its Subsidiaries Subsidiaries’ business with respect to any Healthcare Laws prohibiting, governing, regulating or relating to fee-splitting, self-referrals or payment or receipt of kickbacks in return for or to induce referrals.
(b) Except as would notDuring the past six (6) years, individually neither the Company, its Subsidiaries, nor, to the Company’s knowledge, their respective employees have (i) been reprimanded, sanctioned, excluded or disciplined by any licensing board or any other body, professional society, hospital, or Third Party Payor Program, (ii) had a judgment or settlement without judgment entered against it, him or her in connection with a malpractice or similar action, (iii) been found liable or responsible for any civil offense reasonably related to qualifications or competence relating to professional practice or (iv) been terminated from employment for cause, and there exists no basis for any of the aggregate, have a Material Adverse Effect, since January 1, 2021, foregoing.
(c) Neither the Company and nor any of its Subsidiaries have not has billed or received, or caused a customer pharmacy to bill xxxx or receive, any payment or reimbursement from a Third-Third Party Payor Program in excess of amounts allowed by Law, other than as adjusted in the ordinary course of business or in connection with any routine audit or post-payment review by such that is resolved in compliance with applicable Healthcare Laws or Third-Party Payor Program.
(c) Except as would not, individually or in the aggregate, have a Material Adverse Effect, since January 1, 2021, none of the Company, its Subsidiaries, any of its or their respective officers, directors or employees or, to the Knowledge of the Company, any of its or their respective contractors, agents or other representatives: (i) has been convicted of, charged with or entered into any settlement agreement with any Governmental Authority to avoid conviction of, any violation of any Healthcare Laws; (ii) has been excluded, suspended, debarred or proposed for debarment from participation, has received a written notice of their exclusion, suspension or debarment from participation, has been threatened in writing with exclusion, suspension or debarment from participation or is otherwise ineligible to participate in Third-Party Payor Programs; or (iii) has been convicted of, or entered into any settlement agreement with any Governmental Authority to avoid conviction of, any criminal offense relating to the delivery of any item or service under a Third-Party Payor Program or had a civil monetary penalty assessed against them under Section 1128A of the Social Security Act or any regulations promulgated thereunder, in the case of each of clauses (i) through (iii), related to the Company’s and its Subsidiaries’ businesses.
(d) The Company and/or and each of its Subsidiaries (Subsidiaries, as applicable) , maintains a compliance program to meet all applicable Healthcare Laws requirements including, without limitation, appropriate policies and procedures reasonably necessary to (i) meet the requirements for participation in the provision of services toensure compliance with all applicable Healthcare Laws, and the receipt of payment from, the respective Third-Party Payor Programs in which they participate and (ii) ensure that no misconduct occurs by employees, agents, or Affiliates and (iii) promptly identify and rectify any such misconduct (the “Compliance Program”). The Company has made available true and correct copies of all documents and correspondence related to the Compliance Program. No member, manager, officer, employee, contractor or agent of the Company or any Subsidiary is currently, or during the prior six (6) years has been, engaged in any material violation of the Compliance Program. The Company and each of its Subsidiaries has in place policies and procedures designed to confirm that its employees, agents, vendors, and Affiliates are party not, and have not previously been, excluded, suspended or debarred from any federal healthcare program.
(e) Schedule 3.27(e) sets forth a list of all Contracts between the Company and any of its Subsidiaries or Affiliates (including, but not limited to, pharmacies to which it provides management services), on the one or more valid agreements with Third-hand, and any Third Party Payor Programs authorizing such participation Program, on the other hand (collectively, the “Third Party Payor Agreements”). Each Third Party Payor Agreement is in full force and are in material compliance with effect and is valid and binding on the terms of such agreementsCompany or any Subsidiary that is a party thereto. Neither the Company nor any of its Subsidiaries hasis in material breach of, for itself or for material default under, any third partyThird Party Payor Agreement, submitted and no event has occurred that, with the giving of notice or caused lapse of time or both, would constitute a material breach or material default thereunder by the Company or any of its Subsidiaries. The Company has made available a correct and complete copy of each Third Party Payor Agreement together with all amendments, waivers or changes thereto. No Third Party Payor Agreement is currently subject to or is expected to be submitted subject to a Governmental Authority a knowingly false cancellation or knowingly fraudulent claim any other material modification by the other party thereto or is subject to or is expected to be subject to any penalty, right of set off or other charge by the other party thereto for payment.
late performance or delivery, other than modifications, set-offs or charges implemented in the ordinary course of business consistent with past practice. No party to any Third Party Payor Agreement has asserted to the Company or any of its Subsidiaries any claim, defense, setoff (eother than set-offs or charges implemented in the ordinary course of business consistent with past practice) None or counterclaim under or, to the knowledge of the Company, its Subsidiaries, threatened to terminate any of its or their respective officers, directors, or employees or, to the Knowledge of the Company, any of its or their respective contractors, agents or other representatives is, and none has been since January 1, 2021, a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement, or other formal or informal agreement with any Governmental Authority concerning alleged noncompliance with Healthcare LawsThird Party Payor Agreement.
(f) The Company has adopted and implemented compliance policies that are designed to address the requirements of Healthcare Laws and have been structured in light of the guidance promulgated by the U.S. Department of Health and Human Services, Office of Inspector General on what constitutes an effective compliance program.
Appears in 1 contract
Compliance with Healthcare Laws. (a) The Company and each member of its Subsidiaries are, the Company Group is and have has been since January 1, 2021, at all times in compliance in all material respects with all applicable Healthcare Laws.
(b) The Company and each member of the Company Group, and each and every Patient Service Provider, has all Permits required under any applicable Healthcare Law, and all such Permits are valid, currently in effect, have not previously been revoked or suspended by any Healthcare Regulatory Authority, and are not the subject of any pending or threatened investigation, compliance review, revocation, suspension, or governmental enforcement action. The Company and each member of the Company Group have appropriate systems and policies in place to verify and monitor the continue eligibility of all Patient Service Providers employed by, or under contract with the Company and/or Company Group.
(c) Company Disclosure Schedule 4.17(c) sets forth each Healthcare Regulatory Authorization held by the Company, by each member of the Company Group, and by each Patient Service Provider, and the Company has provided access to Parent true, correct and complete copies of all such Healthcare Regulatory Authorizations. The Healthcare Regulatory Authorizations held by each member of the Company Group are valid and in full force and effect, and collectively constitute all Healthcare Regulatory Authorizations necessary to enable the Company, each member of the Company Group, and each Patient Service Provider to conduct their business and provide services in the manner in which the business is currently being conducted. The Company, each member of the Company Group, and each Patient Service Provider is, and at all times, has been, in material compliance with the terms and requirements of all Healthcare Laws and Third-Party Payor Program rules, except as would not, individually or in the aggregate, have a Material Adverse Effectall Healthcare Regulatory Authorizations. Except as would not, individually or in the aggregate, have a Material Adverse Effect, no Action has been filed, commenced or, to None of the Company’s Knowledge, threatened against members of the Company Group, or its Subsidiaries alleging Patient Service Providers has received any written notice or other communication from any Authority or Healthcare Regulatory Authority regarding (a) any alleged violation or failure to comply with any term or requirement of any Permit or Healthcare Law and Regulatory Authorization; or (b) any investigation or proceeding that could result in the revocation, withdrawal, suspension, cancellation, or termination of any Permit or Healthcare Regulatory Authorization.
(d) To the Knowledge of Company, no Company Product is (i) adulterated or misbranded within the meaning of the FDCA (or any similar Healthcare Law), or (ii) noncompliant with or in violation of the FDCA (or any other Healthcare Law). Except as set forth in Company Disclosure Schedule 4.17(d), neither the Company, any member of the Company Group, nor any of its Subsidiaries Patient Service Provider, supplier, contract manufacturer or contracted or affiliated clinical research organization, has received written notice any notification from any Governmental Authority relating to alleging or asserting any actual or alleged violation ofof or noncompliance with any applicable Healthcare Laws, default under, noncompliance withPermits or Healthcare Regulatory Authorizations, or complaint alleging the lack of any required Permit or Healthcare Regulatory Authorization. Each Company Product is being or has been developed, manufactured, stored, distributed and marketed in compliance in all material respects with all Healthcare Laws and Healthcare Regulatory Authorizations, including those related to or investigation or inquiry or clinical and non-routine audit by any Governmental Authority with respect toclinical trials, any Healthcare Laws. Except as would notinvestigational use, individually or in the aggregatemarketing approval, have a Material Adverse EffectQuality System Regulations (QSR), neither the Company nor any current good manufacturing practices, packaging, labelling, advertising, storing, promotion, import/export, distribution, provision of its Subsidiaries has received written notice from any Governmental Authority ofsamples, record keeping, and reporting. To the Knowledge of Company, there is no investigation, action or proceeding pending or threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to the Company’s Knowledge there are noany Company Product. No manufacturing site owned, pendingleased, active operated by, or threatened Actions, complaints, investigations, audits or inquiries pertaining to contracted with the Company or any member of its Subsidiaries with respect the Company Group, is subject to a shutdown or import or export prohibition imposed or requested by FDA or another Authority. No event has occurred which would reasonably be expected to lead to any claim, suit, proceeding, investigation, enforcement, inspection or other action by any Authority, Healthcare Laws prohibitingRegulatory Authority, governingincluding without limitation the issuance of any FDA warning letter, regulating untitled letter, or relating request or requirement to fee-splitting, self-referrals make material changes to the Company Products or payment the manner in which such Company Products are manufactured or receipt of kickbacks in return for or to induce referralsdistributed.
(be) Except as would notAll data, individually or in the aggregate, have a Material Adverse Effect, since January 1, 2021, the Company information and its Subsidiaries have not billed or received, or caused a customer pharmacy to bill or receive, any payment or reimbursement from a Third-Party Payor Program in excess of amounts allowed representations made by Law, other than as adjusted in the ordinary course of business or in connection with any routine audit or post-payment review by such that is resolved in compliance with applicable Healthcare Laws or Third-Party Payor Program.
(c) Except as would not, individually or in the aggregate, have a Material Adverse Effect, since January 1, 2021, none of the Company, its Subsidiariesany member of the Company Group, any of its or their respective officers, directors or employees or, to the Knowledge of the Company, any Patient Service Provider, and contained in any submission to, or communications with, any Healthcare Regulatory Authority were accurate, complete, truthful and non-misleading in all material respects when submitted or communicated to such Healthcare Regulatory Authority and remain so currently. All clinical, pre-clinical, non-clinical, manufacturing and product quality studies and tests conducted in development of its Company Products or their respective contractorsservices offered, agents and upon which the Company has relied or intends to rely in support of any application or other representatives: (i) has been convicted of, charged with or entered into any settlement agreement with any Governmental Authority submission to avoid conviction of, any violation of any Healthcare Laws; (ii) has been excluded, suspended, debarred or proposed for debarment from participation, has received a written notice of their exclusion, suspension or debarment from participation, has been threatened in writing with exclusion, suspension or debarment from participation or is otherwise ineligible to participate in Third-Party Payor Programs; or (iii) has been convicted of, or entered into any settlement agreement with any Governmental Regulatory Authority to avoid conviction of, any criminal offense relating to the delivery of any item or service under a Third-Party Payor Program or had a civil monetary penalty assessed against them under Section 1128A of the Social Security Act or any regulations promulgated thereunder, in the case of each of clauses (i) through (iii), related to the Company’s and its Subsidiaries’ businesses.
(d) The Company and/or its Subsidiaries (as applicable) (i) meet the requirements for participation in the provision of services to, and the receipt of payment from, the respective Third-Party Payor Programs in which they participate and (ii) are party to one or more valid agreements with Third-Party Payor Programs authorizing such participation and are were conducted in material compliance with the terms of such agreements. Neither the Company nor any of its Subsidiaries has, for itself or for any third party, submitted or caused to be submitted to a Governmental Authority a knowingly false or knowingly fraudulent claim for payment.
(e) None of the Company, its Subsidiaries, any of its or their respective officers, directors, or employees or, to the Knowledge of the Company, any of its or their respective contractors, agents or other representatives is, and none has been since January 1, 2021, a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement, or other formal or informal agreement with any Governmental Authority concerning alleged noncompliance with all applicable Healthcare Laws.
(f) All required Permits, approvals and authorizations for clinical studies to proceed have been obtained from an appropriate Healthcare Regulatory Authority and an appropriate Institutional Review Board, and informed consent, in material compliance with applicable Healthcare Laws, has been obtained from all subjects enrolled in each such study. The Company has adopted and implemented compliance policies that are designed to address not received any written or oral notice or correspondence from the requirements FDA or any other Healthcare Regulatory Authority or from any Institutional Review Board imposing a clinical hold or otherwise requiring the termination, suspension or material modification of Healthcare Laws and have been structured in light any ongoing or planned clinical trials conducted by, or on behalf of, the Company or any member of the guidance promulgated Company Group.
(g) Except as set forth in Company Disclosure Schedule 3.13(g), no member of the Company Group has voluntarily or involuntarily initiated, conducted or issued, caused to be initiated, or been subjected to any Order relating to, any clinical hold or other termination or suspension of any clinical studies, recall or any field corrective action, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals, consumers or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Company Product, nor is any member of the Company Group currently considering initiating, conducting or issuing any of the foregoing actions with respect to any Company Product. No member of the Company Group has received any written notice from the FDA or any other Authority regarding the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by any member of the U.S. Department Company Group.
(h) No member, nor any employee or Patient Service Provider, of the Company Group has been charged in, identified as a target or subject of, or threatened to be charged in or identified as a target or subject of, any material investigation, audit or inquiry by any Person, Authority or Regulatory Authority under any Healthcare Law.
(i) To the Knowledge of Company, no member of the Company Group nor any of their current officers, directors, managers, members, partners, Patient Service Providers or employees, has engaged or is engaging, in any activities which reasonably may give cause for civil monetary or criminal penalties or mandatory or permissive exclusion from any healthcare program defined in 42 U.S.C. §1320a-7b(f) (each, a “Health Care Program”).
(j) No member of the Company Group nor any of their Affiliates, officers, directors, managers, members, partners, Patient Service Provider or employees has: (i) been debarred, excluded or received notice of action or threat of action with respect to debarment, exclusion or other action under the provisions of 21 U.S.C. §§ 335a, 335b, or 335c, 42 U.S.C. § 1320a-7 or any equivalent provisions in any other applicable jurisdiction; (ii) to the Knowledge of Company, made or offered any payment, gratuity or other thing of value that is prohibited by any law to personnel of the FDA or any other Authority; (iii) to the Knowledge of Company, made an untrue statement of a material fact or fraudulent statement to the FDA or other Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Authority, or in any records and Human Servicesdocumentation prepared or maintained to comply with applicable Laws, Office or committed any act, made any statement, or failed to make any statement that, at the time such disclosure was made could reasonably be expected to provide a basis for the FDA or any other Authority to invoke its policy respecting “Fraud, Untrue Statements of Inspector General on what constitutes an effective compliance programMaterial Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy, nor (v) received written notice of or been subject to any other material enforcement action involving the FDA or any other Authority, including any suspension, consent decree, notice of criminal investigation, indictment, sentencing memorandum, plea agreement, Order or target or no-target letter that would reasonably be expected to result in a Company Material Adverse Effect, and, to the Knowledge of Company, none of the foregoing are pending or threatened in writing against the Company, and member of the Company Group or any Patient Service Provider.
Appears in 1 contract
Compliance with Healthcare Laws. (a) The Company Except as set forth on Section 7.16 of the AHP Disclosure Schedule, there is no investigation or Action currently pending against AHP, AHP IPA, or any Professional Personnel or relating to the AHP Business for any violation or alleged violation of a Health Care Law and no event has occurred and no event fact, circumstance or condition exists that has or reasonably may be expected to result in any such investigation or Action. Neither AHP, AHP IPA nor any Professional Personnel has received any notice or threat of any Action pursuant to or involving a Health Care Law.
(b) AHP and AHP IPA has timely filed all material forms, applications, reports, statements, data and other information required to be filed with Governmental Entities in connection with the Health Care Laws.
(c) AHP and AHP IPA and each of its Subsidiaries AHP IPA’s managers, officers, employees and agents (while acting in such capacity) are, and have been since January 1, 2021for the past six (6) years, in compliance with all applicable Healthcare Laws the Health Care Laws. AHP and Third-Party Payor Program rules, except as would not, individually or in the aggregateAHP IPA, have a Material Adverse Effect. Except as would not, individually or in the aggregate, have a Material Adverse Effect, no Action has been filed, commenced or, to the Company’s Knowledge, threatened against the Company or its Subsidiaries alleging any failure to comply with any Healthcare Law and neither the Company nor any of its Subsidiaries has received written notice from any Governmental Authority relating to any actual or alleged violation of, default under, noncompliance with, or complaint to or investigation or inquiry or non-routine audit by any Governmental Authority with respect to, any Healthcare Laws. Except as would not, individually or in the aggregate, have a Material Adverse Effect, neither the Company nor any of its Subsidiaries has received written notice from any Governmental Authority of, and to the Company’s Knowledge there are no, pending, active or threatened Actions, complaints, investigations, audits or inquiries pertaining to the Company or any of its Subsidiaries with respect to any Healthcare Laws prohibiting, governing, regulating or relating to fee-splitting, self-referrals or payment or receipt of kickbacks in return for or to induce referrals.
(b) Except as would not, individually or in the aggregate, have a Material Adverse Effect, since January 1, 2021, the Company and its Subsidiaries have not billed or received, or caused a customer pharmacy to bill or receive, any payment or reimbursement from a Third-Party Payor Program in excess of amounts allowed by Law, other than as adjusted in the ordinary course of business or in connection with any routine audit or post-payment review by such that is resolved in compliance with applicable Healthcare Laws or Third-Party Payor Program.
(c) Except as would not, individually or in the aggregate, have a Material Adverse Effect, since January 1, 2021, none of the Company, its Subsidiaries, any of its or their respective officers, directors or employees or, to the Knowledge of the Company, any of its or their respective contractors, agents or other representatives: (i) has been convicted of, charged with or entered into any settlement agreement with any Governmental Authority to avoid conviction ofimpermissible “financial relationship” or accepted, any violation of any Healthcare Laws; (ii) has been excluded, suspended, debarred or proposed for debarment from participation, has received a written notice of their exclusion, suspension or debarment from participation, has been threatened in writing with exclusion, suspension or debarment from participation or is otherwise ineligible to participate in Third-Party Payor Programs; or (iii) has been convicted ofsolicited, or entered into offered referrals or otherwise had any settlement agreement with any Governmental Authority to avoid conviction of, any criminal offense relating to the delivery of any item business generated by or service under a Third-Party Payor Program or had a civil monetary penalty assessed against them under Section 1128A of the Social Security Act from physicians or any regulations promulgated thereunder, in other actual or potential referral sources that do not otherwise comply with the case of each of clauses (i) through (iii), related to the Company’s and its Subsidiaries’ businessesHealth Care Laws.
(d) The Company and/or AHP IPA have adopted and implemented a compliance plan reasonably designed to ensure its Subsidiaries (as applicable) (i) meet the requirements for participation in the provision of services to, and the receipt of payment from, the respective Third-Party Payor Programs in which they participate and (ii) are party to one or more valid agreements with Third-Party Payor Programs authorizing such participation and are in material compliance with the terms of such agreements. Neither the Company nor any of its Subsidiaries hasapplicable Laws including, for itself or for any third partywithout limitation, submitted or caused to be submitted to a Governmental Authority a knowingly false or knowingly fraudulent claim for paymentHealth Care Laws.
(e) None AHP IPA is in compliance with the Privacy Laws. Each of AHP IPA’s policies relating to the privacy and security of “Protected Health Information” (as defined under HIPAA) comply in all respects with the Privacy Laws. There has been no unauthorized use, modification, disclosure, transfer, loss, destruction or compromise of Protected Health Information or other personal data (including payment card information), no Person has claimed any compensation from AHP or AHP IPA for the loss of or unauthorized use, modification, disclosure, transfer, loss, destruction or compromise of Protected Health Information or personal data (including payment card information), and no facts or circumstances exist that might give rise to such a claim against any AHP or AHP IPA. All information systems used by AHP IPA are sufficient for the conduct of the CompanyAHP IPA Business as currently conducted and as presently proposed to be conducted, and no such information system has suffered any material failures, breakdowns, continued substandard performance or other adverse events that have caused or could reasonably be expected to result in the substantial disruption or interruption in or to the use of such information systems and/or the conduct of the Business. There are no bugs, viruses or defects, design or documentation errors, corruption or malicious computer code or programs present in any information system used by or relied on by AHP and AHP IPA. AHP IPA takes all steps necessary to protect the Protected Health Information and other personal data in its Subsidiaries, any possession or control and to safeguard the integrity of all information systems used by AHP IPA. AHP IPA has entered into business associate agreements that comply with HIPAA with each of its or their respective officersservice providers that creates, directorsreceives, or employees ormaintains and/or transmits Protected Health Information on AHP IPA’s behalf, and have provided Buyer with a true and correct copy of all such business associate agreements. AHP IPA currently maintains, and has maintained for the six (6) years prior to the Knowledge of the Company, any of its or their respective contractors, agents or other representatives is, and none has been since January 1, 2021date hereof, a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement, or other formal or informal agreement plan with any Governmental Authority concerning alleged noncompliance with Healthcare Lawsrespect to business continuity and disaster recovery activities.
(f) The Company Neither any AHP, AHP IPA, nor any Professional Personnel: (i) is or has adopted and implemented compliance policies that are designed been a party to address a corporate integrity agreement with the requirements Office of Healthcare Laws and have been structured in light Inspector General of the guidance promulgated by the U.S. Department of Health and Human Services, Office (ii) has any reporting obligations pursuant to any settlement agreement entered into with any Governmental Entity, (iii) has been the subject of Inspector General any investigation conducted by any Governmental Entity, (iv) has been a defendant in any qui tam or false claims act litigation, (v) has been served with or received any search warrant, subpoena, civil investigative demand, or contact letter by or from any federal or state enforcement agency, or (vi) has ever received any complaints from an employee, independent contractor, vendor, physician, or any other person that alleges that AHP has violated any Health Care Law.
(g) Each Professional Personnel has, at all times he or she has provided services through AHP IPA, been and is duly licensed to practice in the State of California and, each such Professional Personnel who is permitted by law to dispense or prescribe drugs has been and is validly registered with the United States Drug Enforcement Administration (“DEA”) under the Controlled Substances Act. No event has occurred and no fact, circumstance or condition exists that has or reasonably may be expected to result in the denial, loss, revocation, or rescission of or to any such professional license, DEA registration or accreditation application.
(h) Except as set forth on what constitutes Schedule 7.16(h), to AHP’s Knowledge, no Professional Personnel: (i) has had a final judgment or settlement without judgment entered against him/her in connection with a malpractice or similar action; (ii) during the time the applicable health care professional provided or provides services for the Business, used or abused drugs, alcohol or any controlled substances (other than those medications lawfully prescribed by a medical doctor that do not interfere with that person’s capacity to perform his or her duties); (iii) is the subject of any criminal complaint, indictment or criminal proceedings; or (iv) is subject to any allegation, or any investigation or proceeding based on any allegation of violating professional ethics or standards, or engaging in illegal, immoral or other misconduct (of any nature or degree), relating to his/her practice.
(i) Except as set forth on Schedule 7.16(i), no Professional Personnel has given any AHP or AHP IPA notice of his or her intention to: (i) cease providing services through HP, (ii) retire from the practice of professional services within the next five (5) years, (iii) relocate outside of areas where the Business provides services, (iv) otherwise terminate or materially alter his or her relationship with AHP IPA, or (v) breach his or her Agreement with AHP IPA.
(j) All Professional Personnel are properly credentialed and appointed to provide services through AHP IPA and have properly reassigned his or her right to payment for such services to AHP IPA. Set forth in the Schedule 7.16(j) is a correct and complete list of all provider numbers and National Provider Identifiers relating to AHP IPA or for which AHP IPA has used in connection with the enrollment in, and billing of, all Governmental Entity.
(k) There are no agreements between AHP IPA, on the one hand, and any Person, on the other hand, that deviate from or which conflict with any of the Health Care Laws.
(l) AHP IPA properly bills Governmental Programs for all “referrals” of any “designated health services” by “physicians” who have a “financial relationship” with AHP IPA (as such quoted terms are defined under the Sxxxx Law). All revenues relating to designated health services are distributed or paid in a manner compliant with the Sxxxx Law’s in-office ancillary services exception. Except as set forth on Schedule 7.16(l), AHP IPA does not have any reimbursement or payment rate appeals, disputes or contested positions currently pending before any Governmental Entity or any administrator of any Private Programs.
(m) AHP IPA has paid or caused to be paid all known and undisputed refunds, overpayments, discounts or adjustments which have become due pursuant to such reports and bxxxxxxx and AHP and AHP IPA have no liability under any Government Program or Private Program for any refund, overpayment, discount or adjustment. In the past six (6) years, no investigation, validation review or program integrity review related to the AHP Business has been conducted by any commission, board or agency in connection with any Government Program, and no such reviews are scheduled, pending or threatened against or affecting the Business.
(n) Neither AHP, AHP IPA nor any of its managers, officers, employees and agents is currently participating in, or is permitting others to conduct any clinical research study at any Leased Real Property.
(o) With respect to the generation, transportation, treatment, storage, disposal and other handling of medical waste, AHP IPA is and has been, in compliance in all material respects with the Medical Waste Tracking Act of 1988, 42 U.S.C. § 6992, et seq., the United States Public Vessel Medical Waste Anti-Dumping Act of 1988, 33 U.S.C. § 2501, et seq., the Marine Protection, Research and Sanctuaries Act of 1972, 33 U.S.C. § 1401 et seq., the Occupational Safety and Health Act, 29 U.S.C. § 651, et seq., the United States Department of Health and Human Services, National Institute for Occupational Self-Safety and Health Infectious Waste Disposal Guidelines, Publication No. 88-119, et seq., and all other applicable Laws regulating medical waste or imposing requirements relating to medical waste.
(p) Neither AHP, AHP IPA nor any Professional Personnel has ever been indicted or charged or investigated in connection with any violation of any Law involving false or fraudulent billing practices, or relating to its participation in Programs in the last six (6) years, except as set forth on Schedule 4.21(p). In the last six (6) years, HP has billed all Programs in material compliance with all applicable Laws and material contractual obligations. Neither AHP, AHP IPA nor its managers, officers, employees and agents (while acting in such capacity), engaged in any of the following in the past six (6) years: (i) making or causing to be made a false statement or representation of a material fact in any application for any benefit or payment under any Government Program; (ii) making or causing to be made any false statement or representation of a material fact for use in determining rights to any benefit or payment under any Government Program; (iii) failing to disclose knowledge it had of any event affecting the initial or continued right to any benefit or payment under any Government Program on its own behalf or on behalf of another, with an effective compliance programintent to fraudulently secure such benefit or payment either in a greater amount or quantity than is due or when no such benefit or payment is authorized; (iv) soliciting, paying, or receiving any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind or offering to pay such remuneration (1) in return for referring an individual to a Person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part by any Government Program, or (2) in return for purchasing, leasing or ordering or arranging for or recommending the purchasing, leasing or ordering of any good, facility, service, or item for which payment may be made in whole or in part by any Government Program; (v) presenting or causing to be presented a claim for reimbursement for services that is for an item or service that was known or should have been known to be (1) not provided as claimed, or (2) false or fraudulent; or (vi) knowingly and willfully making or causing to be made or inducing or seeking to induce the making of any false statement or representation of a material fact or omitting a material fact required to be stated therein, or necessary to make the statements contained therein not misleading, with respect to information required to be provided under 42 USC §1320a-3.
Appears in 1 contract
Compliance with Healthcare Laws. (a) The In the past three years, the Company and each of its Subsidiaries are, subsidiaries (i) are and at all times have been since January 1, 2021, in material compliance with all statutes, rules or regulations of the U.S. Food and Drug Administration (“FDA”), the U.S. Department of Health and Human Services (“HHS”), Drug Enforcement Administration (“DEA”) and other comparable governmental or regulatory authorities and contractual requirements applicable Healthcare Laws to the ownership, testing, development, manufacture, packaging, processing (including by sterilizing or irradiating), use, distribution, labeling, storage, import, export or disposal of any article tested, developed, manufactured, packaged, processed or distributed by the Company (collectively, the “Food and Third-Party Payor Program rulesDrug Laws”); (ii) have not received written notice that the FDA, HHS, DEA or any comparable governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any licenses, certificates, approvals, clearances, exemptions, authorizations, permits, registrations and supplements or amendments required by the FDA, HHS, DEA or any comparable governmental or regulatory authority (“Authorizations”) and have no knowledge that the FDA, HHS, DEA or any comparable governmental or regulatory authority is considering such action and have no reason to believe that any such Authorizations will not be renewed in the ordinary course, except as would notnot reasonably be expected to have a Material Adverse Effect; and (iii) have not received any FDA Form 483, individually notice of adverse finding, warning letter, untitled letter or in other correspondence or written notice from FDA, HHS, DEA, or any comparable governmental or regulatory authority alleging or asserting noncompliance with applicable statutes, rules and regulations, except for such FDA Form 483s, notices of adverse finding, warning letters, untitled letters or other correspondence or written notices that have been resolved as of the aggregate, date hereof or as would not have a Material Adverse Effect. Except as would not, individually or in the aggregate, have a Material Adverse Effect, no Action has been filed, commenced or, to the Company’s Knowledge, threatened against the Company or its Subsidiaries alleging any failure to comply with any Healthcare Law and neither the Company nor any of its Subsidiaries has received written notice from any Governmental Authority relating to any actual or alleged violation of, default under, noncompliance with, or complaint to or investigation or inquiry or non-routine audit by any Governmental Authority with respect to, any Healthcare Laws. Except as would not, individually or in the aggregate, have a Material Adverse Effect, neither the Company nor any of its Subsidiaries has received written notice from any Governmental Authority of, and to the Company’s Knowledge there are no, pending, active or threatened Actions, complaints, investigations, audits or inquiries pertaining to the Company or any of its Subsidiaries with respect to any Healthcare Laws prohibiting, governing, regulating or relating to fee-splitting, self-referrals or payment or receipt of kickbacks in return for or to induce referrals.
(b) Except as would not, individually or in the aggregate, have a Material Adverse Effect, since January 1, 2021, the Company and its Subsidiaries have not billed or received, or caused a customer pharmacy to bill or receive, any payment or reimbursement from a Third-Party Payor Program in excess of amounts allowed by Law, other than as adjusted in the ordinary course of business or in connection with any routine audit or post-payment review by such that is resolved in compliance with applicable Healthcare Laws or Third-Party Payor Program.
(c) Except as would not, individually or in the aggregate, have a Material Adverse Effect, since January 1, 2021Additionally, none of the Company, its Subsidiariessubsidiaries, any of its or their respective employees, officers, directors or employees directors, or, to the Knowledge of the Company’s knowledge, any of its or their respective contractorsagents, agents or other representatives: (i) has been convicted of, charged with or entered into any settlement agreement with any Governmental Authority to avoid conviction of, any violation of any Healthcare Laws; (ii) has been excluded, suspended, debarred or proposed for debarment disqualified from participationparticipation in any U.S. federal health care program or human clinical research or, has received to the knowledge of the Company or its subsidiaries, is subject to a written notice of their governmental inquiry, claim, investigation, proceeding, or other similar action that would reasonably be expected to result in any such exclusion, suspension suspension, debarment or debarment from participation, disqualification or has been threatened engaged in writing with any conduct that would reasonably be expected to result in any such exclusion, suspension suspension, debarment or debarment from participation or is otherwise ineligible to participate in Third-Party Payor Programs; or (iii) has been convicted ofdisqualification, or entered into any settlement agreement with any Governmental Authority to avoid conviction of, any criminal offense relating to the delivery of any item or service under a Third-Party Payor Program or had a civil monetary penalty assessed against them under Section 1128A of the Social Security Act or any regulations promulgated thereunder, except in the case of each the employees of clauses the Company or its subsidiaries, as would not have a material effect on the Company or its subsidiaries. In the past three years, the Company has complied with DEA instructions with respect to the irradiation of cannabis in the United States, including cannabis that meets the definition of “marihuana” under 21 U.S.C. § 802(16).
(i) through The tests, studies, and clinical trials conducted by or on behalf of or sponsored by the Company or its subsidiaries (iii“Studies”), related to or in which any of the Company’s Company or its subsidiaries has participated, were and, if still ongoing, are being conducted in accordance with protocols, procedures and its Subsidiaries’ businesses.
(d) The Company and/or its Subsidiaries (as applicable) (i) meet the requirements controls designed and approved for participation in the provision of services tosuch tests, studies, and clinical trials and with accepted professional medical and scientific research procedures and standards and all applicable Food and Drug Laws, and Authorizations of the receipt of payment from, the respective Third-Party Payor Programs jurisdiction in which they participate such Studies are being conducted in all material respects; and (ii) are party the Company and its subsidiaries have not received any written notices, correspondence or other communications from the FDA, HHS, DEA or DOJ or any governmental or regulatory authority or similar entity requiring or threatening the termination or suspension of any Studies or with respect to one or more valid agreements with Third-Party Payor Programs authorizing such participation and are in material compliance with the terms performance of such agreements. Neither the Company nor any of its Subsidiaries hasStudies, except for itself such notices, correspondence or for any third party, submitted or caused to be submitted to a Governmental Authority a knowingly false or knowingly fraudulent claim for payment.
(e) None communications that have been resolved as of the date hereof or as would not have an adverse effect on the Company, its Subsidiaries, any of its or their respective officers, directors, or employees or, to the Knowledge . None of the Company, any of its subsidiaries or their respective contractorsany director, agents officer, employee, agent, employee or affiliate of the Company or its subsidiaries has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other representatives isgovernmental or regulatory authority to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and none has been since January 1, 2021, a party to, Illegal Gratuities,” or bound by, any order, individual integrity agreement, corporate integrity agreement, or other formal or informal agreement with any Governmental Authority concerning alleged noncompliance with Healthcare Lawssimilar policies.
(f) The Company has adopted and implemented compliance policies that are designed to address the requirements of Healthcare Laws and have been structured in light of the guidance promulgated by the U.S. Department of Health and Human Services, Office of Inspector General on what constitutes an effective compliance program.
Appears in 1 contract
Compliance with Healthcare Laws. (a) The Company and each of the Acquired Companies is conducting and has since the Lookback Date conducted its Subsidiaries are, business and have been since January 1, 2021, operations in material compliance with all applicable Healthcare Laws and Third-Party Payor Program rules, except as would notLaws.
(b) Except as, individually or in the aggregate, have has not been, and would not reasonably be expected to be, material to the Company and the Acquired Companies, taken as a Material Adverse Effectwhole, since the Lookback Date, each Healthcare Facility operated by the Acquired Companies (i) is certified for participation in the Medicare and Medicaid programs (collectively, “Government Payment Programs”); and (ii) is in compliance in all material respects with the conditions of participation in such Government Payment Programs. All Government Payment Programs in which an Acquired Company is currently participating and all associated provider numbers for such Government Payment Programs are listed in Section 3.21(b) of the Company Disclosure Schedule.
(c) Except as would notas, individually or in the aggregate, have a Material Adverse Effecthas not been, no Action has been filedand would not reasonably be expected to be, commenced or, material to the Company’s KnowledgeCompany and the Acquired Companies, threatened against taken as a whole, since the Lookback Date (i) all claims submitted to any Government Payment Program by the Company or its Subsidiaries alleging any failure and each of the Acquired Companies have been in compliance in all material respects with all Laws applicable to comply with any Healthcare Law such Government Payment Programs, and neither (ii) the Company nor any and each of its Subsidiaries has received written notice from any Governmental Authority relating the Acquired Companies have repaid or caused to be repaid all material known and undisputed refunds or overpayments which have become due to any actual or alleged violation of, default under, noncompliance withGovernment Payment Program, or complaint will repay or cause to be repaid such refunds or investigation or inquiry or non-routine audit by any Governmental Authority with respect tooverpayments, any Healthcare Laws. within the timeframes set forth in 42 C.F.R. § 401.305 and 42 CFR § 422.326.
(d) Except as would notset forth on Section 3.21(d) of the Company Disclosure Schedule, individually (i) since the Lookback Date, and except for any ordinary course surveys, audits or in the aggregate, have a Material Adverse Effectother inspections, neither the Company nor any of its Subsidiaries the Acquired Companies has received written notice from any Governmental Authority ofEntity any written notice or written communication alleging material noncompliance (or with respect to any subpoena or civil investigative demand relating to potential material noncompliance) by the Acquired Companies with any Healthcare Laws that has not been cured in all material respects, and to (ii) there is no civil, criminal or administrative Legal Proceeding or any material governmental action including any civil investigative demand or subpoena (other than investigations or sealed Legal Proceedings that are not within the Knowledge of the Company’s Knowledge there are no) alleging material noncompliance under any Healthcare Laws or related to material noncompliance with, pendingor asserting any material liability under, active or threatened Actions, complaints, investigations, audits or inquiries pertaining to any Healthcare Laws that is currently pending against the Company or any of its Subsidiaries with respect to any Healthcare Laws prohibiting, governing, regulating or relating to fee-splitting, self-referrals or payment or receipt of kickbacks in return for or to induce referrals.
the Acquired Companies and (biii) Except as would not, individually or in since the aggregate, have a Material Adverse Effect, since January 1, 2021, the Company and its Subsidiaries have not billed or received, or caused a customer pharmacy to bill or receive, any payment or reimbursement from a Third-Party Payor Program in excess of amounts allowed by Law, other than as adjusted in the ordinary course of business or in connection with any routine audit or post-payment review by such that is resolved in compliance with applicable Healthcare Laws or Third-Party Payor Program.
(c) Except as would not, individually or in the aggregate, have a Material Adverse Effect, since January 1, 2021Lookback Date, none of the Company, its Subsidiaries, any of its or their respective officers, directors or employees the Acquired Companies or, to the Knowledge of the Company, any of its director, officer or their respective contractors, agents or other representatives: (i) has been convicted of, charged with or entered into any settlement agreement with any Governmental Authority to avoid conviction of, any violation of any Healthcare Laws; (ii) has been excluded, suspended, debarred or proposed for debarment from participation, has received a written notice of their exclusion, suspension or debarment from participation, has been threatened in writing with exclusion, suspension or debarment from participation or is otherwise ineligible to participate in Third-Party Payor Programs; or (iii) has been convicted of, or entered into any settlement agreement with any Governmental Authority to avoid conviction of, any criminal offense relating to the delivery of any item or service under a Third-Party Payor Program or had a civil monetary penalty assessed against them under Section 1128A managing employee of the Social Security Act Company or any regulations promulgated thereunder, in the case of each of clauses (i) through (iii), related to the Company’s and its Subsidiaries’ businesses.
(d) The Company and/or its Subsidiaries (as applicable) (i) meet the requirements for participation in the provision of services to, and the receipt of payment from, the respective Third-Party Payor Programs in which they participate and (ii) are party to one or more valid agreements with Third-Party Payor Programs authorizing such participation and are in material compliance with the terms of such agreements. Neither the Company nor any of its Subsidiaries has, for itself or for any third party, submitted or caused to be submitted to a Governmental Authority a knowingly false or knowingly fraudulent claim for payment.
(e) None of the Company, its Subsidiaries, any of its or their respective officers, directors, or employees Acquired Companies or, to the Knowledge of the CompanyCompany any independent contractor providing direct care services to residents or patients on behalf of any Healthcare Facility, any of its or their respective contractors, agents or other representatives is, and none has been since January 1debarred or excluded from participation any Government Payment Program, 2021or, a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement, or other formal or informal agreement with any Governmental Authority concerning alleged noncompliance with Healthcare Laws.
(f) The Company has adopted and implemented compliance policies that are designed to address the requirements of Healthcare Laws and have been structured in light of the guidance promulgated by the U.S. Department of Health and Human Services, Office of Inspector General on what constitutes an effective compliance program.the
Appears in 1 contract
Samples: Merger Agreement (Diversicare Healthcare Services, Inc.)
Compliance with Healthcare Laws. To Borrower’s knowledge (a) The Company after due inquiry and each of its Subsidiaries areinvestigation), Borrower and have been since January 1, 2021, Property Manager are in compliance in all material respects with all applicable Healthcare Laws except, as disclosed to Lender in writing, for deficiencies as a result of Prudential Loan Nos. 706109321 - 706109336 and Third-Party Payor Program rules, except as would not, individually 706109394 CNL BV Portfolio Second Amended and Restated Loan Agreement surveys or in the aggregate, have a Material Adverse Effect. Except as would not, individually or in the aggregate, have a Material Adverse Effect, no Action has been filed, commenced or, to the Company’s Knowledge, threatened against the Company or its Subsidiaries alleging any failure to comply with any Healthcare Law and neither the Company nor any of its Subsidiaries has received written notice from any Governmental Authority relating to any actual or alleged violation of, default under, noncompliance with, or complaint to or investigation or inquiry or non-routine audit by any Governmental Authority with respect to, any Healthcare Laws. Except as would not, individually or in the aggregate, have a Material Adverse Effect, neither the Company nor any of its Subsidiaries has received written notice from any Governmental Authority of, and to the Company’s Knowledge there are no, pending, active or threatened Actions, complaints, investigations, audits or inquiries pertaining to the Company or any of its Subsidiaries with respect to any Healthcare Laws prohibiting, governing, regulating or relating to fee-splitting, self-referrals or payment or receipt of kickbacks in return for or to induce referrals.
(b) Except as would not, individually or in the aggregate, have a Material Adverse Effect, since January 1, 2021, the Company and its Subsidiaries have not billed or received, or caused a customer pharmacy to bill or receive, any payment or reimbursement from a Third-Party Payor Program in excess of amounts allowed by Law, other than as adjusted reviews that will be corrected in the ordinary course of business or (but in connection with any routine audit or post-payment review by such that no event does a survey violation exist which is resolved in compliance with applicable Healthcare Laws or Third-Party Payor Program.
(c) Except as would not, individually or in the aggregate, not capable of being cured and could reasonably be expected to have a Material Adverse Effectmaterial adverse effect on Borrower’s Individual Property). To Borrower’s knowledge (after due inquiry and investigation), since January 1neither Borrower, 2021Property Manager, none nor any Affiliate and/or employee of the CompanyBorrower or Property Manager or any Affiliate is currently under investigation or prosecution for, its Subsidiariesnor has Borrower, Property Manager or any Affiliate or employee of its Borrower or their respective officers, directors Property Manager or employees or, to the Knowledge of the Company, any of its or their respective contractors, agents or other representatives: (i) has Affiliate been convicted of, charged with : (a) any offense related to the delivery of an item or entered into any settlement agreement with any Governmental Authority to avoid conviction of, any violation of any Healthcare Laws; (ii) has been excluded, suspended, debarred or proposed for debarment from participation, has received a written notice of their exclusion, suspension or debarment from participation, has been threatened in writing with exclusion, suspension or debarment from participation or is otherwise ineligible to participate in Third-service under the Third Party Payor Programs; or (iiib) has been convicted of, or entered into any settlement agreement with any Governmental Authority to avoid conviction of, any a criminal offense relating related to neglect or abuse of patients in connection with the delivery of any a health care item or service under a Third-Party Payor Program service; (c) fraud, theft, embezzlement or had a civil monetary penalty assessed against them under Section 1128A other financial misconduct; (d) the obstruction of the Social Security Act or an investigation of any regulations promulgated thereunder, crime referred to in the case of each of clauses subsections (ia) through (iii), related to the Company’s and its Subsidiaries’ businesses.
(dc) The Company and/or its Subsidiaries (as applicable) (i) meet the requirements for participation in the provision of services to, and the receipt of payment from, the respective Third-Party Payor Programs in which they participate and (ii) are party to one this Section; or more valid agreements with Third-Party Payor Programs authorizing such participation and are in material compliance with the terms of such agreements. Neither the Company nor any of its Subsidiaries has, for itself or for any third party, submitted or caused to be submitted to a Governmental Authority a knowingly false or knowingly fraudulent claim for payment.
(e) None unlawful manufacture, distribution, prescription, or dispensing of a controlled substance. To Borrower’s knowledge (after due inquiry and investigation), neither Borrower, Property Manager, nor any Affiliate and/or employee of Borrower, Property Manager or any Affiliate has been required to pay any civil money penalty under applicable laws regarding false, fraudulent or impermissible claims or payments to induce a reduction or limitation of health care services to beneficiaries of any state or federal health care program, nor, to Borrower’s knowledge (after due inquiry and investigation), is Borrower, Property Manager, nor any Affiliate and/or employee of Borrower, Property Manager or any Affiliate currently the Companysubject of any investigation or proceeding that may result in such payment. Neither Borrower nor, its Subsidiariesto Borrower’s knowledge (after due inquiry and investigation), Property Manager, nor any Affiliate and/or employee of Borrower, nor, to Borrower’s knowledge (after due inquiry and investigation), any Affiliate and/or employee of its or their respective officers, directors, or employees or, to the Knowledge of the Company, any of its or their respective contractors, agents or other representatives is, and none Property Manager has been since January 1, 2021, a party to, excluded from participation in Medicare or bound by, any order, individual integrity agreement, corporate integrity agreement, or other formal or informal agreement with any Governmental Authority concerning alleged noncompliance with Healthcare LawsTRICARE.
(f) The Company has adopted and implemented compliance policies that are designed to address the requirements of Healthcare Laws and have been structured in light of the guidance promulgated by the U.S. Department of Health and Human Services, Office of Inspector General on what constitutes an effective compliance program.
Appears in 1 contract
Compliance with Healthcare Laws. To Borrower’s knowledge (a) The Company after due inquiry and each of its Subsidiaries areinvestigation), Borrower and have been since January 1, 2021, Property Manager are in compliance in all material respects with all applicable Healthcare Laws and Third-Party Payor Program rulesexcept, except as would notdisclosed to Lender in writing, individually for deficiencies as a result of surveys or in the aggregate, have a Material Adverse Effect. Except as would not, individually or in the aggregate, have a Material Adverse Effect, no Action has been filed, commenced or, to the Company’s Knowledge, threatened against the Company or its Subsidiaries alleging any failure to comply with any Healthcare Law and neither the Company nor any of its Subsidiaries has received written notice from any Governmental Authority relating to any actual or alleged violation of, default under, noncompliance with, or complaint to or investigation or inquiry or non-routine audit by any Governmental Authority with respect to, any Healthcare Laws. Except as would not, individually or in the aggregate, have a Material Adverse Effect, neither the Company nor any of its Subsidiaries has received written notice from any Governmental Authority of, and to the Company’s Knowledge there are no, pending, active or threatened Actions, complaints, investigations, audits or inquiries pertaining to the Company or any of its Subsidiaries with respect to any Healthcare Laws prohibiting, governing, regulating or relating to fee-splitting, self-referrals or payment or receipt of kickbacks in return for or to induce referrals.
(b) Except as would not, individually or in the aggregate, have a Material Adverse Effect, since January 1, 2021, the Company and its Subsidiaries have not billed or received, or caused a customer pharmacy to bill or receive, any payment or reimbursement from a Third-Party Payor Program in excess of amounts allowed by Law, other than as adjusted reviews that will be corrected in the ordinary course of business or (but in connection with any routine audit or post-payment review by such that no event does a survey violation exist which is resolved in compliance with applicable Healthcare Laws or Third-Party Payor Program.
(c) Except as would not, individually or in the aggregate, not capable of being cured and could reasonably be expected to have a Material Adverse Effectmaterial adverse effect on Borrower’s Individual Property). To Borrower’s knowledge (after due inquiry and investigation), since January 1neither Borrower, 2021Property Manager, none nor any Affiliate and/or employee of the CompanyBorrower or Property Manager or any Affiliate is currently under investigation or prosecution for, its Subsidiariesnor has Borrower, Property Manager or any Affiliate or Prudential Loan Nos. 706109321 - 706109336 CNL BV Portfolio Amended and Restated Loan Agreement employee of its Borrower or their respective officers, directors Property Manager or employees or, to the Knowledge of the Company, any of its or their respective contractors, agents or other representatives: (i) has Affiliate been convicted of, charged with : (a) any offense related to the delivery of an item or entered into any settlement agreement with any Governmental Authority to avoid conviction of, any violation of any Healthcare Laws; (ii) has been excluded, suspended, debarred or proposed for debarment from participation, has received a written notice of their exclusion, suspension or debarment from participation, has been threatened in writing with exclusion, suspension or debarment from participation or is otherwise ineligible to participate in Third-service under the Third Party Payor Programs; or (iiib) has been convicted of, or entered into any settlement agreement with any Governmental Authority to avoid conviction of, any a criminal offense relating related to neglect or abuse of patients in connection with the delivery of any a health care item or service under a Third-Party Payor Program service; (c) fraud, theft, embezzlement or had a civil monetary penalty assessed against them under Section 1128A other financial misconduct; (d) the obstruction of the Social Security Act or an investigation of any regulations promulgated thereunder, crime referred to in the case of each of clauses subsections (ia) through (iii), related to the Company’s and its Subsidiaries’ businesses.
(dc) The Company and/or its Subsidiaries (as applicable) (i) meet the requirements for participation in the provision of services to, and the receipt of payment from, the respective Third-Party Payor Programs in which they participate and (ii) are party to one this Section; or more valid agreements with Third-Party Payor Programs authorizing such participation and are in material compliance with the terms of such agreements. Neither the Company nor any of its Subsidiaries has, for itself or for any third party, submitted or caused to be submitted to a Governmental Authority a knowingly false or knowingly fraudulent claim for payment.
(e) None unlawful manufacture, distribution, prescription, or dispensing of a controlled substance. To Borrower’s knowledge (after due inquiry and investigation), neither Borrower, Property Manager, nor any Affiliate and/or employee of Borrower, Property Manager or any Affiliate has been required to pay any civil money penalty under applicable laws regarding false, fraudulent or impermissible claims or payments to induce a reduction or limitation of health care services to beneficiaries of any state or federal health care program, nor, to Borrower’s knowledge (after due inquiry and investigation), is Borrower, Property Manager, nor any Affiliate and/or employee of Borrower, Property Manager or any Affiliate currently the Companysubject of any investigation or proceeding that may result in such payment. Neither Borrower nor, its Subsidiariesto Borrower’s knowledge (after due inquiry and investigation), Property Manager, nor any Affiliate and/or employee of Borrower, nor, to Borrower’s knowledge (after due inquiry and investigation), any Affiliate and/or employee of its or their respective officers, directors, or employees or, to the Knowledge of the Company, any of its or their respective contractors, agents or other representatives is, and none Property Manager has been since January 1, 2021, a party to, excluded from participation in Medicare or bound by, any order, individual integrity agreement, corporate integrity agreement, or other formal or informal agreement with any Governmental Authority concerning alleged noncompliance with Healthcare LawsTRICARE.
(f) The Company has adopted and implemented compliance policies that are designed to address the requirements of Healthcare Laws and have been structured in light of the guidance promulgated by the U.S. Department of Health and Human Services, Office of Inspector General on what constitutes an effective compliance program.
Appears in 1 contract
Compliance with Healthcare Laws. (a) The In the past three years, the Company and each of its Subsidiaries are, subsidiaries (i) are and at all times have been since January 1, 2021, in material compliance with all statutes, rules or regulations of the U.S. Food and Drug Administration (“FDA”), the U.S. Department of Health and Human Services (“HHS”), Drug Enforcement Administration (“DEA”), and other comparable governmental or regulatory authorities and contractual requirements applicable Healthcare Laws to the ownership, testing, development, manufacture, packaging, processing (including by sterilizing or irradiating), use, distribution, labeling, storage, import, export or disposal of any article tested, developed, manufactured, packaged, processed or distributed by the Company (collectively, the “Food and Third-Party Payor Program rulesDrug Laws”); (ii) have not received written notice that the FDA, HHS, DEA or any comparable governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any licenses, certificates, approvals, clearances, exemptions, authorizations, permits, registrations and supplements or amendments required by the FDA, HHS, DEA or any comparable governmental or regulatory authority (“Authorizations”) and have no knowledge that the FDA, HHS, DEA or any comparable governmental or regulatory authority is considering such action and have no reason to believe that any such Authorizations will not be renewed in the ordinary course, except as would notnot reasonably be expected to have a Material Adverse Effect; and (iii) have not received any FDA Form 483, individually notice of adverse finding, warning letter, untitled letter or in other correspondence or written notice from FDA, HHS, DEA or any comparable governmental or regulatory authority alleging or asserting noncompliance with applicable statutes, rules and regulations, except for such FDA Form 483s, notices of adverse finding, warning letters, untitled letters or other correspondence or written notices that have been resolved as of the aggregate, date hereof or as would not have a Material Adverse Effect. Except as would not, individually or in the aggregate, have a Material Adverse Effect, no Action has been filed, commenced or, to the Company’s Knowledge, threatened against the Company or its Subsidiaries alleging any failure to comply with any Healthcare Law and neither the Company nor any of its Subsidiaries has received written notice from any Governmental Authority relating to any actual or alleged violation of, default under, noncompliance with, or complaint to or investigation or inquiry or non-routine audit by any Governmental Authority with respect to, any Healthcare Laws. Except as would not, individually or in the aggregate, have a Material Adverse Effect, neither the Company nor any of its Subsidiaries has received written notice from any Governmental Authority of, and to the Company’s Knowledge there are no, pending, active or threatened Actions, complaints, investigations, audits or inquiries pertaining to the Company or any of its Subsidiaries with respect to any Healthcare Laws prohibiting, governing, regulating or relating to fee-splitting, self-referrals or payment or receipt of kickbacks in return for or to induce referrals.
(b) Except as would not, individually or in the aggregate, have a Material Adverse Effect, since January 1, 2021, the Company and its Subsidiaries have not billed or received, or caused a customer pharmacy to bill or receive, any payment or reimbursement from a Third-Party Payor Program in excess of amounts allowed by Law, other than as adjusted in the ordinary course of business or in connection with any routine audit or post-payment review by such that is resolved in compliance with applicable Healthcare Laws or Third-Party Payor Program.
(c) Except as would not, individually or in the aggregate, have a Material Adverse Effect, since January 1, 2021Additionally, none of the Company, its Subsidiariessubsidiaries, any of its or their respective employees, officers, directors or employees directors, or, to the Knowledge of the Company’s knowledge, any of its or their respective contractorsagents, agents or other representatives: (i) has been convicted of, charged with or entered into any settlement agreement with any Governmental Authority to avoid conviction of, any violation of any Healthcare Laws; (ii) has been excluded, suspended, debarred or proposed for debarment from participation, has received a written notice of their exclusion, suspension or debarment from participation, has been threatened in writing with exclusion, suspension or debarment disqualified from participation in any U.S. federal health care program or is otherwise ineligible to participate in Third-Party Payor Programs; or (iii) has been convicted of, or entered into any settlement agreement with any Governmental Authority to avoid conviction of, any criminal offense relating to the delivery of any item or service under a Third-Party Payor Program or had a civil monetary penalty assessed against them under Section 1128A of the Social Security Act or any regulations promulgated thereunder, in the case of each of clauses (i) through (iii), related to the Company’s and its Subsidiaries’ businesses.
(d) The Company and/or its Subsidiaries (as applicable) (i) meet the requirements for participation in the provision of services to, and the receipt of payment from, the respective Third-Party Payor Programs in which they participate and (ii) are party to one or more valid agreements with Third-Party Payor Programs authorizing such participation and are in material compliance with the terms of such agreements. Neither the Company nor any of its Subsidiaries has, for itself or for any third party, submitted or caused to be submitted to a Governmental Authority a knowingly false or knowingly fraudulent claim for payment.
(e) None of the Company, its Subsidiaries, any of its or their respective officers, directors, or employees human clinical research or, to the Knowledge knowledge of the CompanyCompany or its subsidiaries, any of its or their respective contractorsis subject to a governmental inquiry, agents or other representatives isclaim, and none has been since January 1investigation, 2021, a party to, or bound by, any order, individual integrity agreement, corporate integrity agreementproceeding, or other formal similar action that would reasonably be expected to result in any such exclusion, suspension, debarment or informal agreement with disqualification or has engaged in any Governmental Authority concerning alleged noncompliance with Healthcare Laws.
(f) The conduct that would reasonably be expected to result in any such exclusion, suspension, debarment or disqualification. In the past three years, the Company has adopted and implemented compliance policies complied with DEA instructions with respect to the irradiation of cannabis in the United States, including cannabis that are designed to address meets the requirements definition of Healthcare Laws and have been structured in light of the guidance promulgated by the U.S. Department of Health and Human Services, Office of Inspector General on what constitutes an effective compliance program“marihuana” under 21 U.S.C. § 802(16).
Appears in 1 contract
Compliance with Healthcare Laws. (ai) The Company and each of its Subsidiaries are, and have been since January 1, 2021, in compliance with all applicable Healthcare Laws and Third-Party Payor Program rulesWith respect to any federal or state governmental funded health care programs, except as would not, individually or disclosed in the aggregateRegistration Statement, have a Material Adverse Effect. Except as would notthe General Disclosure Package, individually the Statutory Prospectus and the Prospectus, there are no (i) violations of any applicable rule, regulation, policy or in the aggregaterequirement of any such program or any irregularity with respect to any activity, have a Material Adverse Effect, no Action has been filed, commenced or, to the Company’s Knowledge, threatened against practice or policy of the Company or its Subsidiaries alleging subsidiaries; or (ii) violations of any failure applicable rule, regulation, policy or requirement of any such program or any irregularity with respect to comply with any Healthcare Law and neither claim for payment or reimbursement made by the Company nor or its subsidiaries or any of its Subsidiaries has received written notice from any Governmental Authority relating to any actual payment or alleged violation of, default under, noncompliance with, or complaint to or investigation or inquiry or non-routine audit by any Governmental Authority with respect to, any Healthcare Laws. Except as would not, individually or in the aggregate, have a Material Adverse Effect, neither the Company nor any of its Subsidiaries has received written notice from any Governmental Authority of, and to the Company’s Knowledge there are no, pending, active or threatened Actions, complaints, investigations, audits or inquiries pertaining reimbursement paid to the Company or its subsidiaries; nor are there any grounds to anticipate the commencement of its Subsidiaries any investigation or inquiry, or the assertion of any claim or demand by any government agency, intermediary or carrier with respect to any Healthcare Laws prohibitingof the activities, governingpractices, regulating policies or relating to fee-splitting, self-referrals or payment or receipt claims of kickbacks in return for or to induce referrals.
(b) Except as would not, individually or in the aggregate, have a Material Adverse Effect, since January 1, 2021, the Company and or its Subsidiaries have not billed subsidiaries or received, or caused a customer pharmacy to bill or receive, any payment or reimbursement from a Third-Party Payor Program in excess of amounts allowed by Law, other than as adjusted in the ordinary course of business or in connection with any routine audit or post-payment review by such that is resolved in compliance with applicable Healthcare Laws or Third-Party Payor Program.
(c) Except as would not, individually or in the aggregate, have a Material Adverse Effect, since January 1, 2021, none of the Company, its Subsidiaries, any of its or their respective officers, directors or employees or, to the Knowledge of the Company, any of its or their respective contractors, agents or other representatives: (i) has been convicted of, charged with or entered into any settlement agreement with any Governmental Authority to avoid conviction of, any violation of any Healthcare Laws; (ii) has been excluded, suspended, debarred or proposed for debarment from participation, has received a written notice of their exclusion, suspension or debarment from participation, has been threatened in writing with exclusion, suspension or debarment from participation or is otherwise ineligible to participate in Third-Party Payor Programs; or (iii) has been convicted of, or entered into any settlement agreement with any Governmental Authority to avoid conviction of, any criminal offense relating to the delivery of any item or service under a Third-Party Payor Program or had a civil monetary penalty assessed against them under Section 1128A of the Social Security Act or any regulations promulgated thereunder, in the case of each of clauses (i) through (iii), related to the Company’s and business or the subsidiaries business, or any payments or reimbursements claimed by the Company or its Subsidiaries’ businesses.
(d) The Company and/or its Subsidiaries (as applicable) (i) meet the requirements for participation in the provision of services to, and the receipt of payment from, the respective Third-Party Payor Programs in which they participate and (ii) are party to one or more valid agreements with Third-Party Payor Programs authorizing such participation and are in material compliance with the terms of such agreementssubsidiaries. Neither the Company nor any of its Subsidiaries hassubsidiaries are currently subject to any outstanding audit by any such governmental agency, carrier or contractor except as such audit may be performed in the ordinary course of business.
(ii) The Company has not violated and is substantially in compliance in all material respects with all applicable laws. The Company has not received any notice to the effect that, or otherwise been advised that, it is not in compliance with any laws, and the Company has no reason to anticipate that any existing circumstances are likely to result in a violation of any law.
(iii) Neither the Company nor any subsidiary has knowingly or willfully solicited, received, paid or offered to pay any remuneration, directly or indirectly, overtly or covertly, in cash or in-kind for itself the purpose of making or for receiving any third partyreferral which violated any applicable anti-kickback law, including without limitation the Federal Health Care Program Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x) (known as the “Anti-Kickback Statute”), or any applicable state anti-kickback law.
(iv) Neither the Company nor any subsidiary has knowingly submitted or nor caused to be submitted to a Governmental Authority a knowingly false or knowingly fraudulent any claim for payment.
(e) None of the Companypayment to any governmental health program, its Subsidiariesincluding but not limited to Medicare, any of its or their respective officersTRICARE, directorsand Medicaid, or employees orany non-governmental health plan, including but not limited to the Knowledge of the Companythose offered by private health insurers, any of its or their respective contractorshealth maintenance organizations, agents or other representatives ispreferred provider organizations, and none has been since January 1other third party reimbursement and payment programs in violation of any laws relating to false claim or fraud, 2021including without limitation the Federal False Claim Act, a party to31 U.S.C. § 3729, or bound by, any order, individual integrity agreement, corporate integrity agreement, applicable state false claim or other formal or informal agreement with any Governmental Authority concerning alleged noncompliance with Healthcare Lawsfraud law.
(f) The Company has adopted and implemented compliance policies that are designed to address the requirements of Healthcare Laws and have been structured in light of the guidance promulgated by the U.S. Department of Health and Human Services, Office of Inspector General on what constitutes an effective compliance program.
Appears in 1 contract
Compliance with Healthcare Laws. Except as disclosed in the Registration Statement and the Prospectus, the Company: (ai) The Company is and each of its Subsidiaries are, and have at all times has been since January 1, 2021, in compliance with all applicable Healthcare U.S., Canadian and foreign statutes, rules, regulations, or guidances applicable to the Company and the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“Applicable Laws”), except where such noncompliance would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change; (ii) has not received any warning letter, untitled letter or other correspondence or written notice from the U.S. Food and Drug Administration or any other U.S. or Canadian federal, state, provincial or foreign governmental authority having authority over the Company (“Governmental Authority”) alleging or asserting noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and Third-Party Payor Program rulessupplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iii) possesses all Authorizations and such Authorizations are valid and in full force and effect and are not in violation of any term of any such Authorizations, except as would not, individually or in the aggregate, have reasonably be expected to result in a Material Adverse Effect. Except as would not, individually or in the aggregate, have a Material Adverse Effect, no Action Change; (iv) has been filed, commenced or, to the Company’s Knowledge, threatened against the Company or its Subsidiaries alleging any failure to comply with any Healthcare Law and neither the Company nor any of its Subsidiaries has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Authority relating to or third party alleging that any actual product operation or alleged activity is in violation ofof any Applicable Laws or Authorizations and have no knowledge that any such Governmental Authority or third party is considering any such claim, default underlitigation, noncompliance witharbitration, or complaint to or action, suit, investigation or inquiry or non-routine audit by proceeding; (v) has not received written notice that any Governmental Authority with respect tohas taken, is taking or intends to take action to limit, suspend, modify or revoke any Healthcare Laws. Except as would not, individually or in the aggregate, have a Material Adverse Effect, neither Authorizations and the Company nor has no knowledge that any of its Subsidiaries has received written notice from any such Governmental Authority ofis considering such action; and (vi) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and to the Company’s Knowledge there are no, pending, active supplements or threatened Actions, complaints, investigations, audits or inquiries pertaining to the Company or amendments as required by any of its Subsidiaries with respect to any Healthcare Laws prohibiting, governing, regulating or relating to fee-splitting, self-referrals or payment or receipt of kickbacks in return for or to induce referrals.
(b) Except as would not, individually or in the aggregate, have a Material Adverse Effect, since January 1, 2021, the Company and its Subsidiaries have not billed or received, or caused a customer pharmacy to bill or receive, any payment or reimbursement from a Third-Party Payor Program in excess of amounts allowed by Law, other than as adjusted in the ordinary course of business or in connection with any routine audit or post-payment review by such that is resolved in compliance with applicable Healthcare Applicable Laws or Third-Party Payor ProgramAuthorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission).
(c) Except as would not, individually or in the aggregate, have a Material Adverse Effect, since January 1, 2021, none of the Company, its Subsidiaries, any of its or their respective officers, directors or employees or, to the Knowledge of the Company, any of its or their respective contractors, agents or other representatives: (i) has been convicted of, charged with or entered into any settlement agreement with any Governmental Authority to avoid conviction of, any violation of any Healthcare Laws; (ii) has been excluded, suspended, debarred or proposed for debarment from participation, has received a written notice of their exclusion, suspension or debarment from participation, has been threatened in writing with exclusion, suspension or debarment from participation or is otherwise ineligible to participate in Third-Party Payor Programs; or (iii) has been convicted of, or entered into any settlement agreement with any Governmental Authority to avoid conviction of, any criminal offense relating to the delivery of any item or service under a Third-Party Payor Program or had a civil monetary penalty assessed against them under Section 1128A of the Social Security Act or any regulations promulgated thereunder, in the case of each of clauses (i) through (iii), related to the Company’s and its Subsidiaries’ businesses.
(d) The Company and/or its Subsidiaries (as applicable) (i) meet the requirements for participation in the provision of services to, and the receipt of payment from, the respective Third-Party Payor Programs in which they participate and (ii) are party to one or more valid agreements with Third-Party Payor Programs authorizing such participation and are in material compliance with the terms of such agreements. Neither the Company nor any of its Subsidiaries has, for itself or for any third party, submitted or caused to be submitted to a Governmental Authority a knowingly false or knowingly fraudulent claim for payment.
(e) None of the Company, its Subsidiaries, any of its or their respective officers, directors, or employees or, to the Knowledge of the Company, any of its or their respective contractors, agents or other representatives is, and none has been since January 1, 2021, a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement, or other formal or informal agreement with any Governmental Authority concerning alleged noncompliance with Healthcare Laws.
(f) The Company has adopted and implemented compliance policies that are designed to address the requirements of Healthcare Laws and have been structured in light of the guidance promulgated by the U.S. Department of Health and Human Services, Office of Inspector General on what constitutes an effective compliance program.
Appears in 1 contract
Samples: Controlled Equity Offering Agreement (Aurinia Pharmaceuticals Inc.)
Compliance with Healthcare Laws. (a) The Company and each of its Subsidiaries Acquired Companies are, and during the last three (3) years have been since January 1, 2021been, in compliance in all material respects with all applicable Healthcare Laws and Third-Party Payor Program rulesLaws. During the last three (3) years, except as would not, individually or in the aggregate, Acquired Companies have a Material Adverse Effect. Except as would not, individually or in the aggregate, have a Material Adverse Effect, no Action has been filed, commenced or, to the Company’s Knowledge, threatened against the Company or its Subsidiaries alleging not received any failure to comply with written notification from any Governmental Authority of: (i) any material violation of any Healthcare Law or (ii) any pending or threatened material Proceeding under any Healthcare Law. The Acquired Companies are not party to any corporate integrity agreement and neither the Company nor do not have reporting obligations pursuant to any of its Subsidiaries has received written notice from deferred prosecution, consent decree, settlement, integrity agreement, corrective action plan or other similar obligation or agreement with any Governmental Authority relating to any actual or alleged violation of, default under, noncompliance with, or complaint to or investigation or inquiry or non-routine audit by any Governmental Authority compliance with respect to, any applicable Healthcare Laws. Except as would not, individually or in the aggregate, have a Material Adverse Effect, neither the Company nor any of its Subsidiaries has received written notice from any Governmental Authority of, and to the Company’s Knowledge there are no, pending, active or threatened Actions, complaints, investigations, audits or inquiries pertaining to the Company or any of its Subsidiaries with respect to any Healthcare Laws prohibiting, governing, regulating or relating to fee-splitting, self-referrals or payment or receipt of kickbacks in return for or to induce referrals.
(b) Except as would notnot reasonably be material to the Acquired Companies, individually or in within the aggregatelast three (3) years, have a Material Adverse Effectneither the Acquired Companies, since January 1, 2021, the Company and its Subsidiaries have not billed or received, or caused a customer pharmacy to bill or receive, any payment or reimbursement from a Third-Party Payor Program in excess of amounts allowed by Law, other than as adjusted in the ordinary course of business or in connection with any routine audit or post-payment review by such that is resolved in compliance with applicable Healthcare Laws or Third-Party Payor Program.
(c) Except as would not, individually or in the aggregate, have a Material Adverse Effect, since January 1, 2021, none of the Company, its Subsidiariesnor, any of its or their respective directors, officers, directors or employees ornor, to the Knowledge of the Company, any of its or their respective contractors, agents is or other representativeshas ever been: (i) has been convicted ofdebarred, charged with excluded, or entered into suspended from participating in any settlement agreement Governmental Health Program, (ii) subject to a civil monetary penalty assessed under Section 1128A of the Social Security Act in connection with any Governmental Authority to avoid conviction of, any material violation of any Healthcare Laws; (ii) has been excludedGovernmental Health Program requirement, suspended, debarred or proposed for debarment from participation, has received a written notice of their exclusion, suspension or debarment from participation, has been threatened in writing with exclusion, suspension or debarment from participation or is otherwise ineligible to participate in Third-Party Payor Programs; or (iii) has been engaged in any activities that are prohibited by or are cause for civil or criminal penalties or mandatory or permissive exclusion under any Healthcare Laws, (iv) listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs, (v) charged with, convicted of, of or entered into any settlement agreement with any Governmental Authority a plea of guilty or nolo contendere to avoid conviction of, any criminal or civil offense relating to the delivery of any item or service under a ThirdGovernmental Health Program, or (vi) has made any voluntary or self-Party disclosure to any Governmental Authority or Payor Program of any potential or had a civil monetary penalty assessed against them under Section 1128A actual non-compliance with any Healthcare Law.
(c) Within the last three (3) years, none of the Social Security Act or any regulations promulgated thereunder, in the case of each of clauses (i) through Acquired Companies is or has been subject to HIPAA as a “covered entity” or “business associate” (iiieach as defined in HIPAA), related to the Company’s and its Subsidiaries’ businesses.
(d) The Company and/or its Subsidiaries (as applicable) (i) meet the requirements for participation in the provision of services to, and the receipt of payment from, the respective Third-Party Payor Programs in which they participate and (ii) are party except as would not reasonably be material to one or more valid agreements with Third-Party Payor Programs authorizing such participation and are in material compliance with the terms of such agreements. Neither Acquired Companies, the Company Acquired Companies, nor any of its Subsidiaries has, for itself or for any third party, submitted or caused to be submitted to a Governmental Authority a knowingly false or knowingly fraudulent claim for payment.
(e) None of the Company, its Subsidiaries, any of its or their respective officers, directors, officers managers, or employees oremployees, nor to the Knowledge of the Company, any of its or their respective independent contractors, agents or other representatives ishas ever used, and none has been since January 1disclosed, 2021created, a party toreceived, maintained, accessed, or bound by, any order, individual integrity agreement, corporate integrity agreement, or other formal or informal agreement with any Governmental Authority concerning alleged noncompliance with Healthcare Lawstransmitted “protected health information” (as defined in HIPAA) to conduct the business of the Acquired Companies.
(fd) The Company has adopted and implemented compliance policies that are designed Except as would not be material to address the requirements of Healthcare Laws and have been structured in light Acquired Companies, none of the guidance promulgated by Acquired Companies employ, contract with, or otherwise engage any healthcare professionals to provide healthcare services on behalf of any of the U.S. Department of Health and Human Services, Office of Inspector General on what constitutes an effective compliance programAcquired Companies.
Appears in 1 contract
Samples: Merger Agreement (Model N, Inc.)
Compliance with Healthcare Laws. (a) The Company Except as set forth on Schedule 3.15(a), Sellers and each of its Subsidiaries the Non-Debtors are, and have been since January 1, 2021, have been, in material compliance with all applicable Healthcare Laws Laws, except as would not individually or in the aggregate, be material to the Business.
(b) Neither Sellers, the Non-Debtors, nor to the Knowledge of Sellers, any of their respective officers, directors, managers, or employees are or have been: (i) excluded, suspended or debarred from participation in any Health Care Program, (ii) subject to a civil monetary penalty assessed under Section 1128A of the Social Security Act, sanctioned, indicted or convicted of a crime, or pled nolo contendere or to sufficient facts, in connection with any material allegation of violation of any applicable Healthcare Law, (iii) listed on the General Services Administration published list of parties excluded from federal procurement programs and Thirdnon-Party Payor Program rulesprocurement programs, in each case of (i) through (iii), that would reasonably be expected to be material to the Acquired Assets and the Assumed Liabilities, taken as a whole.
(c) The Business has not received any written notice or claim of, and there are no investigations or proceedings pending with respect to any alleged “breach” by Xxxxxxx, or their respective “workforces,” each as defined under HIPAA, except as would not reasonably be expected, individually or in the aggregate, to be material to Sellers, the Acquired Assets or the Business.
(d) Each Seller Product is being or has been developed, manufactured, stored, distributed and marketed in compliance in all material respects with applicable Healthcare Laws. Sellers have not voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any material recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigatory notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Seller Product, except as would not, individually or in the aggregate, have a Material Adverse Effect. Except as would not, individually or in the aggregate, have a Material Adverse Effect, no Action has been filed, commenced or, be material to the Company’s Knowledge, threatened against the Company or its Subsidiaries alleging any failure to comply with any Healthcare Law and neither the Company nor any of its Subsidiaries has received written notice from any Governmental Authority relating to any actual or alleged violation of, default under, noncompliance with, or complaint to or investigation or inquiry or non-routine audit by any Governmental Authority with respect to, any Healthcare Laws. Except as would not, individually or in the aggregate, have a Material Adverse Effect, neither the Company nor any of its Subsidiaries has received written notice from any Governmental Authority of, and to the Company’s Knowledge there are no, pending, active or threatened Actions, complaints, investigations, audits or inquiries pertaining to the Company or any of its Subsidiaries with respect to any Healthcare Laws prohibiting, governing, regulating or relating to fee-splitting, self-referrals or payment or receipt of kickbacks in return for or to induce referralsBusiness.
(b) Except as would not, individually or in the aggregate, have a Material Adverse Effect, since January 1, 2021, the Company and its Subsidiaries have not billed or received, or caused a customer pharmacy to bill or receive, any payment or reimbursement from a Third-Party Payor Program in excess of amounts allowed by Law, other than as adjusted in the ordinary course of business or in connection with any routine audit or post-payment review by such that is resolved in compliance with applicable Healthcare Laws or Third-Party Payor Program.
(c) Except as would not, individually or in the aggregate, have a Material Adverse Effect, since January 1, 2021, none of the Company, its Subsidiaries, any of its or their respective officers, directors or employees or, to the Knowledge of the Company, any of its or their respective contractors, agents or other representatives: (i) has been convicted of, charged with or entered into any settlement agreement with any Governmental Authority to avoid conviction of, any violation of any Healthcare Laws; (ii) has been excluded, suspended, debarred or proposed for debarment from participation, has received a written notice of their exclusion, suspension or debarment from participation, has been threatened in writing with exclusion, suspension or debarment from participation or is otherwise ineligible to participate in Third-Party Payor Programs; or (iii) has been convicted of, or entered into any settlement agreement with any Governmental Authority to avoid conviction of, any criminal offense relating to the delivery of any item or service under a Third-Party Payor Program or had a civil monetary penalty assessed against them under Section 1128A of the Social Security Act or any regulations promulgated thereunder, in the case of each of clauses (i) through (iii), related to the Company’s and its Subsidiaries’ businesses.
(d) The Company and/or its Subsidiaries (as applicable) (i) meet the requirements for participation in the provision of services to, and the receipt of payment from, the respective Third-Party Payor Programs in which they participate and (ii) are party to one or more valid agreements with Third-Party Payor Programs authorizing such participation and are in material compliance with the terms of such agreements. Neither the Company nor any of its Subsidiaries has, for itself or for any third party, submitted or caused to be submitted to a Governmental Authority a knowingly false or knowingly fraudulent claim for payment.
(e) None of the Company, its Subsidiaries, any of its or their respective officers, directors, or employees or, to the Knowledge of the Company, any of its or their respective contractors, agents or other representatives is, and none has been since January 1, 2021, a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement, or other formal or informal agreement with any Governmental Authority concerning alleged noncompliance with Healthcare Laws.
(f) The Company has adopted and implemented compliance policies that are designed to address the requirements of Healthcare Laws and have been structured in light of the guidance promulgated by the U.S. Department of Health and Human Services, Office of Inspector General on what constitutes an effective compliance program.
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