Common use of Healthcare Regulatory Matters Clause in Contracts

Healthcare Regulatory Matters. (a) Each Company Group Member is currently in material compliance with and, since January 1, 2019, each Company Group Member has complied in all material respects, with all Applicable Healthcare Industry Laws. Since January 1, 2019, each Company Group Member has maintained and complied in all material respects with a corporate compliance program that includes the implementation of policies, procedures, and training programs, and other compliance activities designed for its employees and agents to comply with all Applicable Healthcare Industry Laws. (b) No Company Group Member has been subject to (or has not received any written notice of) any pending or threatened action by any Governmental Authority alleging any violation of or noncompliance with any Applicable Healthcare Industry Law. The Company has not ever been a party to a corporate integrity agreement with the Office of Inspector General for the U.S. Department of Health and Human Services, or any deferred prosecution agreement or settlement agreement with any Governmental Authority. To the Knowledge of the Company, there is no act, omission, event or circumstance by any Company Group Member that would or reasonably would be expected to result in any such action. (c) No officer or director of the Company Group, or to the Knowledge of the Company, any agent or employee thereof (i) has made any fraudulent or untrue statement to or failed to disclose a fact required to be disclosed to any Governmental Authority or (ii) has committed an act, made a statement or failed to make a statement that would provide the basis for any Governmental Authority to take an adverse action against any Company Group Member under any Applicable Healthcare Industry Laws. (d) No Company Group Member, nor any of their respective employees, managers, partners, directors, officers, contractors, agents, or other persons acting on their behalf is or ever has been debarred, excluded, restricted, prohibited, or terminated from participation in any federal or state health care program, including Medicare and Medicaid. (e) Since January 1, 2019, each Company Group Member has complied in all material respects with the terms of all contracts to provide products or services to any Governmental Authority. (f) Each Company Group Member currently maintains and, for the previous five (5) years, has maintained privacy and security policies, procedures and safeguards that comply in all material respects with applicable HIPAA requirements. When functioning either as a “Covered Entity” or as a “Business Associate” (as defined in 45 C.F.R. § 160.103), each Company Group Member is a party to a business associate agreement with each person who is a Business Associate or a downstream Business Associate of such Company Group Member as required by and in accordance with applicable Privacy Laws. Each Company Group Member has entered into all required Business Associate (as defined in HIPAA) agreements. Each Company Group Member is in material compliance with the terms of each business associate agreement to which it is a party. To the Knowledge of the Company, all third parties that have entered into a business associate agreement with a Company Group Member are in material compliance with the terms of that business associate agreement. To the Knowledge of the Company, all third parties that have provided Personal Information to a Company Group Member have done so in compliance in all material respects with applicable Privacy Laws and applicable business associate agreement terms, including providing any notice and obtaining any applicable authorization or consent when required. No Company Group Member has received written notice of, and there is no litigation, proceeding (at law or in equity) pending or, to the Knowledge of the Company, threatened, and there is no inquiry or investigation pending or threatened with respect to, any alleged Breach of Unsecured PHI, as defined by HIPAA, or any other violation of HIPAA by any Company Group Member or its respective “workforce” (as defined under HIPAA). No Breach of Unsecured PHI by any Company Group Member or its “workforce” and no successful “security incident” (as defined in 45 C.F.R. § 164.304) has occurred with respect to “protected health information” (as defined in 45 C.F.R. § 160.103) in the possession or under the control of any Company Group Member or any business associate or downstream business associate of any Company Group Member. (g) Each Company Group Member is currently in material compliance with and, since January 1, 2019, each Company Group Member has at all times complied, in all material respects, with all terms and conditions of any contract with any government entity including the Centers for Medicare and Medicaid Services within the United States Department of Health and Human Services.

Healthcare Regulatory Matters. (a) Each SCAN Group and each SCAN Company is duly licensed and has all necessary Approvals to perform all of the services provided by SCAN Group Member is currently in material compliance with and, since January 1, 2019, each Company Group Member has complied in all material respects, with all Applicable Healthcare Industry Laws. Since January 1, 2019, each Company Group Member has maintained and complied in all material respects with a corporate compliance program that includes the implementation of policies, procedures, and training programs, and other compliance activities designed for its employees and agents to comply with all Applicable Healthcare Industry Lawssuch SCAN Company. (b) No All Medicare and Medicaid agreements, Permits, Approvals, certifications, regulatory agreements, or other agreements, certificates of operation, completion and occupancy, and other licenses required by Regulatory Authorities for the operation of the SCAN Business have been obtained and are in full force and effect, including, as applicable, approved provider status in any approved Third Party Payor Program in which SCAN Group or any SCAN Company participates (collectively, the “SCAN Health Care Licenses”). SCAN Group Member has been subject to (and the SCAN Companies own and/or possess, and hold free from restrictions or has not received any written notice of) any pending or threatened action by any Governmental Authority alleging any violation of or noncompliance with any Applicable Healthcare Industry Law. The Company has not ever been a party to a corporate integrity agreement conflicts with the Office rights of Inspector General for the U.S. Department of others, all such SCAN Health and Human Services, or any deferred prosecution agreement or settlement agreement with any Governmental Authority. To the Knowledge of the Company, there is no act, omission, event or circumstance by any Company Group Member that would or reasonably would be expected to result in any such actionCare Licenses. (c) No officer or director Except as set forth in Section 5.9(c) of the Company GroupDisclosure Schedules, or to the Knowledge of the Company, any agent or employee thereof (i) has made SCAN Group and the SCAN Companies are, and have been during the last six (6) years, in compliance in all material respects (including its form and rate filing, reserving, marketing, investment, financial, claims, taxation, underwriting, premium collection and refunding, cost and claims reporting, and other practices, as applicable) with all Laws, including without limitation the Insurance Laws, and with all applicable provisions of the requirements of any fraudulent or untrue statement to or failed to disclose a fact required to be disclosed to any Governmental Regulatory Authority or having jurisdiction over the SCAN Business, (ii) none of SCAN Group or any of the SCAN Companies is, nor has committed an actany such entity been in the past six (6) years, made a statement in material violation of any of the provisions of applicable Law with respect to health care service contractors or failed to make a statement that would provide coordinated care organizations, and (iii) none of SCAN Group or any of the basis for SCAN Companies, nor any Governmental Authority to take an adverse action against Person acting on behalf of any Company Group Member such entity, has materially violated or has incurred any material Liability under (A) any Applicable Healthcare Industry federal or state fraud and abuse Laws, including the Xxxxx Law (42 U.S.C. §1395nn), the civil False Claims Act (31 U.S.C. §3729 et seq.), Sections 1320a-7a and 1320a-7b of Title 42 of the United States Code, (B) Medicare (Title XVIII of the Social Security Act), (C) Medicaid (Title XIX of the Social Security Act), (D) any applicable licensure Laws or regulations, or (E) any other applicable Health Care Law or Insurance Law. (d) No Company Where applicable, SCAN Group Member, nor any of their respective employees, managers, partners, directors, officers, contractors, agents, or other persons acting on their behalf is or ever has been debarred, excluded, restricted, prohibited, or terminated from participation in any federal or state health care program, including Medicare and Medicaid. the SCAN Companies (ei) Since January 1, 2019, each Company Group Member has complied in all material respects with the terms of all contracts to provide products or services to any Governmental Authority. (f) Each Company Group Member currently maintains and, for the previous five (5) years, has maintained privacy and security policies, procedures and safeguards that comply in all material respects with applicable HIPAA requirements. When functioning either as a “Covered Entity” or as a “Business Associate” (as defined in 45 C.F.R. § 160.103), each Company Group Member is a party to a business associate agreement with each person who is a Business Associate or a downstream Business Associate of such Company Group Member as required by and in accordance with applicable Privacy Laws. Each Company Group Member has entered into all required Business Associate (as defined in HIPAA) agreements. Each Company Group Member is in material compliance with the terms of each business associate agreement to which it is a party. To the Knowledge of the Company, all third parties that have entered into a business associate agreement with a Company Group Member are in material compliance with the terms of that business associate agreement. To the Knowledge of the Company, all third parties that have provided Personal Information to a Company Group Member have done so in compliance in all material respects with applicable Privacy Laws the requirements for participation in the Medicare and applicable business associate agreement termsMedicaid programs, including providing the Medicaid and Medicare Patient and Program Protection Act of 1987, and (ii) have current provider agreements under Title XVIII and XIX of the Social Security Act, which are in full force and effect. Such SCAN Companies have not had any notice deficiencies on their most recent survey or audit that could result in a termination from the Medicare or Medicaid programs. (e) Except as set forth in Section 5.9(e) of the Disclosure Schedules, neither SCAN Group nor any SCAN Company is a target of, participant in or subject to any Action or sanction by any Regulatory Authority or any other administrative or investigative body or entity or any other third party or any patient, resident, enrollee or member (including whistleblower suits, or suits brought pursuant to federal or state false claims acts or Medicaid/Medicare/State fraud/abuse laws) which is reasonably likely to result, directly or indirectly or with the passage of time, in the imposition of a fine, penalty, alternative, interim or final sanction, a lower rate certification, recoupment, or recovery, or suspension or discontinuance of all or part of reimbursement or capitation payment from any Regulatory Authority or Third Party Payor Program, a lower reimbursement or capitation payment rate for services rendered to eligible patients, or any other civil or criminal remedy, or which is reasonably expected to have a Material Adverse Effect on the SCAN Business or which is reasonably likely to result in the appointment of a receiver or manager, or in the modification, limitation, annulment, revocation, transfer, surrender, suspension, termination, non-renewal or other impairment of an SCAN Health Care License or affect SCAN Group’s or any SCAN Company’s participation in any Third Party Payor Program, as applicable, or any successor program thereto, at current rate certification, nor has any such action, proceeding, suit, investigation proceeding or audit been threatened. (f) For the past six (6) years, SCAN Group and obtaining each SCAN Company has timely filed (taking into account permitted extensions timely obtained, if any) all material regulatory reports, schedules, statements, documents, filings, submissions, forms, registrations and other documents, together with any applicable authorization amendments required to be made with respect thereto, that was required to be filed with any Regulatory Authority (“Regulatory Filings”). All such Regulatory Filings are accurate and complete in all material respects. For the past six (6) years, SCAN Group and each SCAN Company has timely paid (taking into account permitted extensions timely obtained, if any) all fees and assessments due and payable in connection therewith. (g) SCAN Group and the SCAN Companies have not, other than in the ordinary course of business, changed the terms of their normal billing payment or consent when requiredreimbursement policies and related procedures, including the amount and timing of finance charges, fees and write-offs. (h) Except as set forth in Section 5.9(h) of the Disclosure Schedules, no employee of SCAN Group or any SCAN Company has been terminated at any time during the last six (6) years for cause based on a violation or alleged violation of Health Care Laws, or because such person committed a felony against any client or patient, and no employee of SCAN Group or any SCAN Company that has been terminated at any time during the last six (6) years has made any written allegation against any SCAN Group or any SCAN Company in relation to Health Care Laws. (i) None of SCAN Group, any SCAN Company or any officer, director or current employee of SCAN Group or any SCAN Company has ever been debarred, suspended or otherwise excluded from participating in any state or federally funded health care program. No Neither SCAN Group nor any SCAN Company Group Member has received written notice ofhas, and, to the Knowledge of SCAN Group, none of its employees has, engaged in any conduct which could result in debarment or disqualification by any Regulatory Authority, and there is are no litigation, proceeding (at law or in equity) proceedings pending or, to the Knowledge of the SCAN Group, threatened that could reasonably be expected to result in criminal liability, debarment or disqualification by any Regulatory Authority. SCAN Group and each SCAN Company, as applicable, is in good standing with, and not excluded or suspended from participation in, or limited in its right to participate in any Third Party Payor Program. (j) SCAN Group and each SCAN Company that submits bills, claims, claims reports or cost reports to any Third Party Payor Program maintains a corporate compliance program that accords in all material respects with reasonable industry standards, including a billing compliance program, training, evaluation, auditing and discipline for infractions. (k) Except as set forth in Section 5.9(k) of the Disclosure Schedules, during the last six (6) years, none of SCAN Group or any of the SCAN Companies has been required to pay any civil monetary penalty under applicable Law regarding false, fraudulent or impermissible claims or reports under, or payments to induce a reduction or limitation of health care services to beneficiaries of, any state health care program or Federal Health Care Program. To the Knowledge of SCAN Group, none of SCAN Group or any of the SCAN Companies is currently the subject of any investigation, audit or proceeding that may result in such payment. Except as set forth in Section 5.9(k) of the Disclosure Schedules, neither SCAN Group nor any SCAN Company is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders or similar agreements with or imposed by any Governmental Entity under any Law, nor is subject to any investigation or proceeding that may result in any corporate integrity agreement or similar agreement. (l) Except as set forth in Section 5.9(l) of the Disclosure Schedules, there are no material recoupments, adjustments or recovery proceedings being sought, requested, claimed or threatened under any Third Party Payor Program against SCAN Group or any SCAN Company. Except as set forth in Section 5.9(l) of the Disclosure Schedules, for the past six (6) years, none of SCAN Group, any SCAN Company or any officers or directors of SCAN Group or any SCAN Company has received, or has been the subject of, any audit, inquiry, or investigation that requires, or could reasonably be expected to require, the payment of money by SCAN Group or any SCAN Company to any Regulatory Authority, or requires or prohibits any activity by SCAN Group or any SCAN Company, other than routine reconciliations of eligibility, enrollments and disenrollments and any associated recoupments (e.g., audits of incarcerated or deceased Enrollees) (“Routine Reconciliations”). Any and all Routine Reconciliations of which SCAN Group has Knowledge and for which SCAN Group or any SCAN Company has not made repayment in full of the resulting Liability to the applicable Regulatory Authority are set forth in Section 5.9(l) of the Disclosure Schedules. There are no Actions, payment reviews, or other proceedings of which SCAN Group or any SCAN Company has received written notice, or, to the Knowledge of SCAN Group, appeals pending or threatened, and there is no inquiry or investigation pending or threatened with respect to, before any alleged Breach of Unsecured PHI, as defined by HIPAA, or any other violation of HIPAA by any Company Group Member or its respective “workforce” (as defined under HIPAA). No Breach of Unsecured PHI by any Company Group Member or its “workforce” and no successful “security incident” (as defined in 45 C.F.R. § 164.304) has occurred Regulatory Authority with respect to “protected health information” (as defined in 45 C.F.R. § 160.103) any payments received by SCAN Group or any SCAN Company, which could have a Material Adverse Effect, either individually or in the possession or under aggregate, on the control of any Company Group Member or any business associate or downstream business associate of any Company Group MemberSCAN Business. (gm) Each To the Knowledge of SCAN Group, SCAN Group’s and each SCAN Company’s marketing staff has not violated any Laws applicable to the marketing or enrollment of SCAN Group’s or any SCAN Company’s health plans in any material respect. The compensation payable by SCAN Group or any SCAN Company to its marketing staff complies in all material respects with applicable Laws. (n) SCAN Group Member is currently and the SCAN Companies have implemented a corporate compliance program which meets all applicable legal requirements in all material respects and maintain staff to oversee the functioning of the corporate compliance program. As part of its corporate compliance program, SCAN Group and the SCAN Companies have implemented administrative processes, policies and procedures that are reasonably designed to ensure that SCAN Group and the SCAN Companies remain in compliance with and, since January 1, 2019, each Company Group Member has at all times complied, applicable Laws in all material respects. SCAN Group and the SCAN Companies have in place a process to regularly check all applicable federal or state health care program exclusion and debarment lists to determine whether SCAN Group, with all terms and conditions any SCAN Company, any of their respective officers, directors, managers, employees, providers of services or any contract with contracted vendor or agent that provides health care- related services to SCAN Group or any government entity including the Centers for Medicare and Medicaid Services within the United States Department of Health and Human ServicesSCAN Company is excluded, debarred, suspended, or otherwise ineligible to participate in any Third Party Payor Program or in federal procurement or non-procurement programs.

Healthcare Regulatory Matters. (a) Each Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Group Member is currently in material compliance with Material Adverse Effect, each of the Company, the Company Subsidiaries and, since January 1, 2019, each Company Group Member has complied in all material respects, with all Applicable Healthcare Industry Laws. Since January 1, 2019, each Company Group Member has maintained and complied in all material respects with a corporate compliance program that includes the implementation of policies, procedures, and training programs, and other compliance activities designed for its employees and agents to comply with all Applicable Healthcare Industry Laws. (b) No Company Group Member has been subject to (or has not received any written notice of) any pending or threatened action by any Governmental Authority alleging any violation of or noncompliance with any Applicable Healthcare Industry Law. The Company has not ever been a party to a corporate integrity agreement with the Office of Inspector General for the U.S. Department of Health and Human Services, or any deferred prosecution agreement or settlement agreement with any Governmental Authority. To the Knowledge of the Company, there is no actthe Managed Professional Corporations is, omissionand since October 30, event or circumstance by any Company Group Member that 2020, and, to the Company’s Knowledge, since December 12, 2019, has been, in compliance with all Healthcare Laws. Except as has not had and would or not reasonably would be expected to result have, individually or in the aggregate, a Company Material Adverse Effect, neither the Company, any such actionCompany Subsidiary nor, to Knowledge of the Company, any Managed Professional Corporation, has received any written communication from any Governmental Entity or other Person of any non-compliance with, or Proceeding under, any Healthcare Law. (b) Neither the Company, the Company Subsidiaries, nor either of their respective employees, officers or directors nor, to the Knowledge of the Company, agents of the foregoing nor the Managed Professional Corporations nor their respective employees, officers, directors or agents, is or has been since November 25, 2019 and during their affiliation with the Company, the Company Subsidiaries or the Managed Professional Corporations, excluded, suspended or debarred from, or are otherwise ineligible for participation in, any applicable Federal Healthcare Program. Neither the Company, the Company Subsidiaries, nor, to the Knowledge of the Company, the Managed Professional Corporations is a party to, or has any reporting obligations under, any corporate integrity agreements, monitoring agreements, deferred prosecution agreements, consent decrees, orders, settlement agreements or similar agreements with or imposed by any Governmental Entity with respect to any Healthcare Law. To the Company’s Knowledge, since December 12, 2019, no Person has filed or has threatened to file against the Company or any Company Subsidiary or any Managed Professional Corporation under the federal False Claims Act (31 U.S.C. §§ 3729, et seq.) or analogous state whistleblower statute. (c) No officer or director Each of the Company, the Company GroupSubsidiaries and, to the Knowledge of the Company, the Managed Professional Corporations, to the extent applicable, are and since October 30, 2020 and, to the Company’s Knowledge, since December 12, 2019, have been, duly enrolled or credentialed in each Payor Program in which the Company, the Company Subsidiaries and the Managed Professional Corporations participate, and hold all required authorizations for payment by such Payor Programs, except to the extent that any failure to be enrolled or credentialed or to hold all required authorizations, have not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. Since October 30, 2020 and, to the Company’s Knowledge, since December 12, 2019, neither the Company, any Company Subsidiary nor, to the Knowledge of the Company, any agent or employee thereof Managed Professional Corporation has received written communication from any Payor Program (i) has made any fraudulent that such Payor Program is terminating, suspending, withdrawing, not renewing (for cause) or untrue statement to materially limiting the Company, the Company Subsidiaries or failed to disclose a fact required to be disclosed to any Governmental Authority the Managed Professional Corporations’ participation in the Payor Program or (ii) has committed an actof any billing audits, made program integrity reviews, recoupment efforts or similar Proceedings, except in each case with respect to (i) and (ii) above, where such actions have not had and would not reasonably be expected to have, individually or in the aggregate, a statement or failed to make a statement that would provide the basis for any Governmental Authority to take an adverse action against any Company Group Member under any Applicable Healthcare Industry Laws. (d) No Company Group Member, nor any of their respective employees, managers, partners, directors, officers, contractors, agents, or other persons acting on their behalf is or ever has been debarred, excluded, restricted, prohibited, or terminated from participation in any federal or state health care program, including Medicare and Medicaid. (e) Since January 1, 2019, each Company Group Member has complied in all material respects with the terms of all contracts to provide products or services to any Governmental Authority. (f) Each Company Group Member currently maintains and, for the previous five (5) years, has maintained privacy and security policies, procedures and safeguards that comply in all material respects with applicable HIPAA requirements. When functioning either as a “Covered Entity” or as a “Business Associate” (as defined in 45 C.F.R. § 160.103), each Company Group Member is a party to a business associate agreement with each person who is a Business Associate or a downstream Business Associate of such Company Group Member as required by and in accordance with applicable Privacy LawsMaterial Adverse Effect. Each Company Group Member has entered into all required Business Associate (as defined in HIPAA) agreements. Each Company Group Member is in material compliance with the terms of each business associate agreement to which it is a party. To the Knowledge of the Company, all third parties that have entered into a business associate agreement with a the Company Group Member are in material compliance with the terms of that business associate agreement. To the Knowledge of the Company, all third parties that have provided Personal Information to a Company Group Member have done so in compliance in all material respects with applicable Privacy Laws and applicable business associate agreement terms, including providing any notice and obtaining any applicable authorization or consent when required. No Company Group Member has received written notice of, and there is no litigation, proceeding (at law or in equity) pending orSubsidiaries and, to the Knowledge of the Company, threatenedthe Managed Professional Corporations, since October 30, 2020 and, to the Company’s Knowledge, since December 12, 2019, have billed and collected for healthcare services and items, and there is no inquiry maintained accurate and complete records supporting its claims, in compliance with Healthcare Laws and all legally binding policies and requirements applicable to Payor Programs, except where any failure to do so has not had and would not reasonably be expected to have, individually or investigation pending or threatened in the aggregate, a Company Material Adverse Effect. (d) To the Knowledge of the Company, since December 12, 2019, and during their respective affiliation with respect toany Managed Professional Corporation, any alleged Breach of Unsecured PHI, as defined by HIPAAeach healthcare professional employed by, or under contract with any other violation of HIPAA by any Company Group Member or its respective Managed Professional Corporation (“workforce” Healthcare Professional”): (as defined under HIPAA). No Breach of Unsecured PHI by any Company Group Member or its “workforce” and no successful “security incident” (as defined in 45 C.F.R. § 164.304i) has occurred held all required credentials, privileges, permits, licenses or other authorizations or certifications in each jurisdiction where such professionals were or are providing such services for or on behalf of any Managed Professional Corporation and such credentials, privileges, permits, licenses or other authorizations or certifications have not been suspended, revoked or restricted in any manner; and (ii) has complied with all Healthcare Laws, except in each case with respect to “protected health information” (as defined in 45 C.F.R. § 160.103i) and (ii) above, where failure to hold such authorizations or failure to comply, respectively, has not had and would not reasonably be expected to have, individually or in the possession or under the control of any aggregate, a Company Group Member or any business associate or downstream business associate of any Company Group Member. (g) Each Company Group Member is currently in material compliance with Material Adverse Effect. Since October 30, 2020 and, to the Company’s Knowledge, since January 1December 12, 2019, each neither the Company, the Company Group Member Subsidiaries, nor to the Knowledge of the Company, any Managed Professional Corporation, has at all times complied, in all received any written communication from any Governmental Entity regarding any material respects, with all terms and conditions violation of any contract with Healthcare Law by any government entity including the Centers for Medicare and Medicaid Services within the United States Department of Health and Human ServicesHealthcare Professional.

Healthcare Regulatory Matters. (a) Each The Company Group Member is currently and the Company Subsidiaries are in material compliance with andcompliance, since January 1, 2019, each Company Group Member has complied in all material respects, with (i) all Applicable applicable Laws (including, for the avoidance of doubt, good manufacturing practices and good clinical practices) of the FDA, DEA, EMEA and applicable comparable Laws of each other Healthcare Industry LawsRegulatory Authority and (ii) all Healthcare Regulatory Authorizations, including all requirements of the FDA, DEA, the EMEA and all other Healthcare Regulatory Authorities, that are applicable to the Company and the Company Subsidiaries, or by which any property, product or other asset of the Company and the Company Subsidiaries is bound or affected. Since January 1, 20192011, each neither the Company Group Member nor the Company Subsidiaries has maintained and complied in all material respects with a corporate compliance program that includes the implementation of policies, procedures, and training programs, and other compliance activities designed for its employees and agents to comply with all Applicable Healthcare Industry Laws. (b) No Company Group Member has been subject to (or has not received any written notice of) notification of any pending or threatened action by any Governmental Authority alleging any violation of or noncompliance with any Applicable Healthcare Industry Law. The Company has not ever been a party to a corporate integrity agreement with the Office of Inspector General for the U.S. Department of Health and Human Services, or any deferred prosecution agreement or settlement agreement with any Governmental Authority. To the Knowledge of the Company, there is no act, omission, event or circumstance by any Company Group Member that would or reasonably would be expected to result in any such action. (c) No officer or director of the Company Group, or to the Knowledge of the Company, any agent or employee thereof (i) has made any fraudulent or untrue statement to or failed to disclose a fact required to be disclosed to any Governmental Authority or (ii) has committed an act, made a statement or failed to make a statement that would provide the basis for any Governmental Authority to take an adverse action against any Company Group Member under any Applicable Healthcare Industry Laws. (d) No Company Group Member, nor any of their respective employees, managers, partners, directors, officers, contractors, agents, or other persons acting on their behalf is or ever has been debarred, excluded, restricted, prohibited, or terminated from participation in any federal or state health care program, including Medicare and Medicaid. (e) Since January 1, 2019, each Company Group Member has complied in all material respects with the terms of all contracts to provide products or services to any Governmental Authority. (f) Each Company Group Member currently maintains and, for the previous five (5) years, has maintained privacy and security policies, procedures and safeguards that comply in all material respects with applicable HIPAA requirements. When functioning either as a “Covered Entity” or as a “Business Associate” (as defined in 45 C.F.R. § 160.103), each Company Group Member is a party to a business associate agreement with each person who is a Business Associate or a downstream Business Associate of such Company Group Member as required by and in accordance with applicable Privacy Laws. Each Company Group Member has entered into all required Business Associate (as defined in HIPAA) agreements. Each Company Group Member is in material compliance with the terms of each business associate agreement to which it is a party. To the Knowledge of the Company, all third parties that have entered into a business associate agreement with a Company Group Member are in material compliance with the terms of that business associate agreement. To the Knowledge of the Company, all third parties that have provided Personal Information to a Company Group Member have done so in compliance in all material respects with applicable Privacy Laws and applicable business associate agreement terms, including providing any notice and obtaining any applicable authorization or consent when required. No Company Group Member has received written notice of, and there is no litigation, proceeding (at law or in equity) pending or, to the Knowledge of the Company, threatened, claim, Proceeding, enforcement, investigation or other action against the Company or any of the Company Subsidiaries from any Healthcare Regulatory Authority. (b) Except as described in Section 4.11(b) of the Disclosure Schedule, the Company and the Company Subsidiaries have not since January 1, 2011 voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notices of action relating to an alleged lack of safety, efficacy or regulatory compliance of any Product manufactured, distributed or marketed by or on behalf of the Company and the Company Subsidiaries. Except as described in Section 4.11(b) of the Disclosure Schedule, neither the Company nor any of the Company Subsidiaries has received any written notice since January 1, 2011 that the FDA or any other Governmental Authority has (i) commenced, or threatened to initiate, any action to revoke or withdraw a Product approval, or request the recall of any Product, (ii) commenced, or threatened to initiate, any action to enjoin manufacture or distribution of any Product or (iii) commenced, or threatened to initiate, any action to enjoin the manufacture or distribution of any Product produced at any facility where any Product is manufactured, tested, processed, packaged or held for sale. (c) All material reports, documents, claims, notices, licenses and registrations relating to any of the Products that are required to be filed or maintained with or furnished to any Healthcare Regulatory Authority by the Company or any of the Company Subsidiaries have been so filed, maintained or furnished, and all such reports, documents, licenses and registrations were accurate and complete in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). The Company and the Company Subsidiaries are and have been, since January 1, 2009, in compliance with current good manufacturing practices and maintain appropriate mechanisms, policies and procedures to ensure the prompt collection and reporting of adverse events related to the Products. (d) Neither the Company nor any of the Company Subsidiaries has received any material written information since January 1, 2011 from any Healthcare Regulatory Authority or any other state or federal regulatory agencies with jurisdiction over the marketing, sale, use, handling and control, safety, efficacy, reliability, or manufacturing of its Products which would reasonably be expected to lead: (i) to the revocation, withdrawal, or denial of any application for marketing approval before such Healthcare Regulatory Authority, except for any such revocations, withdrawals or denials which, individually or in the aggregate, would not reasonably be expected to be materially adverse to the Company and the Company Subsidiaries; or (ii) to the revocation, withdrawal, denial or restriction of producing or marketing of any Product currently in development or offered for sale which does not require marketing approval, except for any such revocations, withdrawals, denials or restrictions which, individually or in the aggregate, would not reasonably be expected to be materially adverse to the Company and the Company Subsidiaries. (e) There is no Proceeding pending or, to the Knowledge of the Company, threatened in writing against the Company or any Company Subsidiary that would reasonably be expected to result in the exclusion of the Company or any Company Subsidiary from any third party payment program in which it participates. (f) Neither the Company nor any Company Subsidiary or, to the Knowledge of the Company, any of their respective current employees, or former employees, officers, agents, contractors or distributors during the time of their employment or service with such Person, has committed or been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a, any similar Law or authorized by 21 U.S.C. § 335a or any similar applicable Law. (g) Since January 1, 2011, the Company and the Company Subsidiaries have held all material Healthcare Regulatory Authorizations required for the conduct of their respective businesses and all such Healthcare Regulatory Authorizations are and have been in full force and effect. (h) All pre-clinical studies conducted by or on behalf of or sponsored by the Company or the Company Subsidiaries, or in which the Company and the Company Subsidiaries or the Products have participated were and, if still pending, are being conducted in accordance with standard medical and scientific research procedures and all applicable Law, including good laboratory practice requirements in all material respects. The Company and the Company Subsidiaries have not received since January 1, 2011 any written notices, correspondence or other communication from any Healthcare Regulatory Authority requiring the termination or suspension of any clinical studies conducted by, or on behalf of, the Company or any of the Company Subsidiaries, or in which the Company or the any of the Company Subsidiaries have participated. (i) Except as described in Section 4.11(i) of the Disclosure Schedule, since January 1, 2011 the Company and the Company Subsidiaries have not engaged, and none of them is now engaging, in any clinical studies as sponsor, investigator or monitor. (j) Except as described in Section 4.11(j) of the Disclosure Schedule, since January 1, 2011, neither the Company nor any of the Company Subsidiaries has received any FDA Form 483, notice of adverse finding, warning letters, untitled letters or other notices from any Healthcare Regulatory Authority related to the safety, purity, efficacy, labeling, marketing or promotion of any of the Products, and there is no inquiry action or investigation Proceeding pending or, to the Knowledge of the Company, threatened by any such Healthcare Regulatory Authority, contesting the approval of, the uses of, or threatened the labeling or promotion of, or otherwise alleging any violation of Law in any material respect with respect to, any alleged Breach Product manufactured, distributed or marketed by or on behalf of Unsecured PHIthe Company or its Subsidiaries. (k) Neither the Company nor any of the Company Subsidiaries is the subject of any pending or, to the Knowledge of the Company, threatened investigation regarding the Company, the Company Subsidiaries or the Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto (the “Final Policy”), or otherwise engaged in improper conduct contemplated by the Final Policy. Neither the Company nor any of the Company Subsidiaries, nor, to the Knowledge of the Company, any officer, employee, agent, contractor or distributor of the Company or any of the Company Subsidiaries, has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as defined by HIPAAamended, or any similar applicable Law. As of the date of this Agreement, no claims, actions, proceedings or investigations that would reasonably be expected to result in a material debarment or exclusion are pending or, to the Knowledge of the Company, threatened, against the Company or, to the Knowledge of the Company, any of its directors, officers, employees or agents. The Company has made available to Purchaser a true, correct and complete listing of fees, payments and reimbursements paid by the Company and the Company Subsidiaries, including the identity of the recipients of such fees, payments and reimbursements, related to advertising, promotions, conferences, speakerships and sponsorships together with the subject matters thereof, and the Company and the Company Subsidiaries have been and are in compliance with the PhRMA Code on Interactions with Healthcare Professionals. (l) Neither the FDA nor any other violation Healthcare Regulatory Authority of HIPAA by competent jurisdiction has requested, required, demanded or ordered the Company or the Company Subsidiaries or, to the Knowledge of the Company, any Company Group Member Representatives to cease all or its respective a significant portion of the manufacturing operations at the Company’s manufacturing facilities, and, to the Knowledge of the Company, neither the FDA nor any other Healthcare Regulatory Authority of competent jurisdiction has taken any action that could reasonably be expected to lead to such a request, requirement, demand or order. (m) To the Knowledge of the Company, no new drug applications (“workforce” NDAs”) or abbreviated new drug applications (“ANDAs”) submitted by the Company or any of the Company Subsidiaries to any Healthcare Regulatory Authority for approval and which have been approved contain any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements made therein, in the light of the circumstances under which they were made, not misleading, but with respect to those NDAs and ANDAs that have been submitted for approval but which have not been approved, subject to the Company and the Company Subsidiaries having received or receiving ordinary course communications, inquiries and requests for information from Healthcare Regulatory Authorities with respect to the such NDAs or ANDAs. To the Knowledge of the Company, all NDAs and ANDAs submitted by the Company or any of the Company Subsidiaries for approval and which have been approved are true, complete and correct and none is deficient by virtue of any failure to submit a modification, amendment or supplement thereto or for failure to pay any requisite fee, penalty or other charge or expense, but with respect to NDAs and ANDAs that have been submitted for approval but which have not been approved, subject to the Company and the Company Subsidiaries having received or receiving ordinary course communications, inquiries and requests for information from Healthcare Regulatory Authorities with respect to such NDAs and ANDAs. (n) The Company and the Company Subsidiaries have made available to Purchaser true, correct and complete copies of all internal and third party facility audits completed at and on behalf of the Company during the past four (4) years. All facility registrations and product listings required of the Company and the Company Subsidiaries are timely, complete and correct. Section 4.11(n) of the Disclosure Schedule contains a complete list of the Company’s and the Company Subsidiaries’ registered facilities and Products, including an indication of any such Products’ identified status as defined under HIPAA)“grandfathered”, “monograph”, abbreviated new drug application or new drug application. No Breach of Unsecured PHI by The Company and the Company Subsidiaries have not developed, manufactured or distributed and do not currently develop, manufacture or distribute any Company Group Member or its “workforce” and no successful “security incident” biological product subject to a biologics license application (as defined in 45 C.F.R. § 164.30421 CFR 601.2). (o) Neither the FDA nor any other Healthcare Regulatory Authority of competent jurisdiction has occurred requested, required, demanded or ordered the Company, the Company Subsidiaries to discontinue the Company’s Isotretinoin products (except with respect to “protected health information” (as defined in 45 C.F.R. § 160.103Isotretinoin 30mg) in and to the possession Knowledge of the Company, neither the FDA nor any other Healthcare Regulatory Authority of competent jurisdiction has taken any action that would reasonably be expected to lead to such a request, requirement, demand or under the control of any Company Group Member or any business associate or downstream business associate of any Company Group Memberorder. (gp) Each of the Company Group Member is currently in material compliance with and, since January 1, 2019, each and the Company Group Member Subsidiaries has at all times complied, complied in all material respects, respects with all terms applicable security and conditions of privacy standards regarding protected health information under (i) HIPAA and (ii) any contract with any government entity including the Centers for Medicare and Medicaid Services within the United States Department of Health and Human Servicesapplicable privacy Laws.