Common use of Health Care Regulatory Compliance Clause in Contracts

Health Care Regulatory Compliance. (i) Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on Company, Company and its Subsidiaries are, and Company and its Subsidiaries’ businesses are being conducted, in compliance with the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191), as amended by the Health Information Technology for Economic and Clinical Health Act (Pub. L. No. 111-5), any implementing regulations and any state medical information Laws applicable to the business of Company or its Subsidiaries (collectively, the “Privacy Laws”). (ii) Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on Company, Company and each of its Subsidiaries, and to the Knowledge of Company, all of their respective directors, officers, agents and employees, are in compliance with, and Company and each of its Subsidiaries have compliance programs including policies and procedures reasonably designed to cause Company and its Subsidiaries and their respective directors, officers, agents and employees to be in compliance with, to the extent applicable, all Health Care Laws. Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on Company, no third-party payment program has imposed a fine, penalty or other sanction on Company or its Subsidiaries and none of Company or its Subsidiaries has been excluded or suspended from participation in any such program. (iii) Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on Company, neither Company, any of its Subsidiaries, nor to the Knowledge of Company, any director or executive officer of Company or any of its Subsidiaries, with respect to actions taken on behalf of Company or of its Subsidiaries, (A) has been assessed a civil monetary penalty under Section 1128A of the Social Security Act or any regulations promulgated thereunder, (B) has been excluded from participation in any federal health care program or state health care program (as such terms are defined by the Social Security Act), (C) has been convicted of any criminal offense relating to the delivery of any item or service under a federal health care program or (D) is a party to or subject to any action or proceeding concerning any of the matters described above in clauses (A) and (C). (iv) Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on Company, each of Company’s insurance and health maintenance Subsidiaries meets the requirements for participation in, and receipt of payment from, the Medicaid and Medicare Advantage programs in which it participates and is a party to one or more valid agreements with the applicable state Medicaid agencies and CMS, as applicable, authorizing its participation.

Health Care Regulatory Compliance. (i) Except The Non-MCC Entities (solely with respect to the MCC Business) and the Transferred Entities are in compliance in all material respects with all applicable Health Regulatory Laws. Since the Applicable Date through the date of this Agreement, none of the Non-MCC Entities (solely with respect to the MCC Business) nor any of the Transferred Entities has received any written notice from any Governmental Entity regarding any material violation of any applicable Health Regulatory Laws. Since the Applicable Date and through the date of this Agreement, none of the Non-MCC Entities (solely with respect to the MCC Business), the Transferred Entities or, to the Knowledge of the Seller, any of their respective directors, officers, employees, independent contractors, or agents, acting on their behalf with respect to the MCC Business: (A) are or have been convicted of any violation of a Health Regulatory Law, including any Law applicable to a health care program defined in 42 U.S.C. §1320a-7b(f) (“Federal Health Care Program”); (B) are excluded, suspended or debarred from participation in any Federal Health Care Program or, to the Knowledge of the Seller, are subject to any Action or investigation that is reasonably likely to result in such exclusion, suspension, or debarment; or (C) have been assessed a civil monetary penalty under Section 1128A of the Social Security Act. (ii) Since the Applicable Date and through the date of this Agreement, none of the Non-MCC Entities (solely with respect to the MCC Business), the Transferred Entities or, to the Knowledge of the Seller, any of their respective directors, officers, employees, independent contractors, or agents, acting on their behalf with respect to the MCC Business have knowingly made an untrue or fraudulent statement to any Governmental Entity or knowingly failed to disclose a fact required to be disclosed to a Governmental Entity. (iii) Since the Applicable Date through the date of this Agreement, none of the Non-MCC Entities (solely with respect to the MCC Business) nor any of the Transferred Entities have received written notice from any Governmental Entity indicating that the Non-MCC Entities (solely with respect to the MCC Business) or any of the Transferred Entities are subject to any sanctions or enforcement actions by any Governmental Entity responsible for Health Regulatory Laws, including any outstanding fines, injunctions, civil, administrative or criminal penalties, settlement, investigations or suspensions. None of the Non-MCC Entities (solely with respect to the MCC Business) nor any of the Transferred Entities is, nor from the Applicable Date to the date of this Agreement has been: (A) a party to a corporate integrity agreement or similar agreement with any Governmental Entity relating to alleged non-compliance with any applicable Health Regulatory Laws; (B) subject to any reporting obligations pursuant to any settlement agreement, consent decree, monitoring agreement, deferred prosecution agreement or other similar agreement entered into with any Governmental Entity relating to alleged non-compliance with any applicable Health Regulatory Laws; (C) except for the satisfaction of routine requests made by Governmental Entities with respect to the MCC Business which do not impact the business or operations of the MCC Business, a party to any agreement, settlement, consent decree, monitoring agreement or other similar agreement with any Governmental Entity addressing measures to satisfy compliance with any applicable Health Regulatory Laws; or (D) except for the satisfaction of routine requests made by Governmental Entities with respect to the MCC Business which do not impact the business or operations of the MCC Business, subject to any pending or, to the Knowledge of the Seller, threatened, appeals, adjustments, challenges, audits, inquiries, investigations, litigation, or written notices of intent to audit with respect to material reports or xxxxxxxx, or material claims for refunds, overpayments, discounts or adjustments. (iv) As of the date of this Agreement, each Non-MCC Entity (solely with respect to the MCC Business) and each Transferred Entity holds all material Licenses necessary to conduct the MCC Business (the “Health Care Licenses”). All Health Care Licenses are in full force and effect in all material respects and none of the Non-MCC Entities or Transferred Entities is in material violation of the Health Care Licenses. To the Knowledge of the Seller, there is no Action, investigation, or other proceeding that is reasonably likely to result in the termination, cancellation, revocation, suspension, or adverse modification of any Health Care License. To the Knowledge of the Seller, each MCC Business Employee and each independent contractor and consultant providing services on behalf of the MCC Business (in each case solely with respect to the MCC Business) who is required to hold a license, permit, certification, or accreditation to perform his or her job function holds such license, permit, certification, or accreditation. (v) Since the Applicable Date, the Seller and each of the Regulated Subsidiaries has filed all of the Statutory Statements and all other material filings with respect to the MCC Business (including filings with respect to premium rates, rating plans, policy terms, medical loss ratio, capitation rates, encounter data, marketing plans and network adequacy), together with any amendments required to be made with respect thereto, that it was required to file with any Governmental Entity, including CMS, state insurance departments, state departments of health, other applicable state Medicaid authorities, and any other agencies with jurisdiction over the Federal Health Care Programs and including filings that it was required to file under the Patient Protection and Affordable Care Act (Pub. L. 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152), except where the failure to make such Statutory Statements and other filings with respect to the MCC Business has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on Company, Company and its Subsidiaries are, and Company and its Subsidiaries’ businesses are being conducted, in compliance with the Health Insurance Portability and Accountability Act Effect. For purposes of 1996 this subparagraph (Pub. L. No. 104-191v), as amended by the Health Information Technology for Economic and Clinical Health Act (Pub. L. No. 111-5)“Regulated Subsidiary” shall mean each RBC Entity, any implementing regulations The Management Group, LLC and any state medical information Laws applicable to the business of Company or its Subsidiaries other Non-MCC Entity (collectively, the “Privacy Laws”). (ii) Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on Company, Company and each of its Subsidiaries, and to the Knowledge of Company, all of their respective directors, officers, agents and employees, are in compliance with, and Company and each of its Subsidiaries have compliance programs including policies and procedures reasonably designed to cause Company and its Subsidiaries and their respective directors, officers, agents and employees to be in compliance with, to the extent applicable, all Health Care Laws. Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on Company, no third-party payment program has imposed a fine, penalty or other sanction on Company or its Subsidiaries and none of Company or its Subsidiaries has been excluded or suspended from participation in any such program. (iii) Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on Company, neither Company, any of its Subsidiaries, nor to the Knowledge of Company, any director or executive officer of Company or any of its Subsidiaries, solely with respect to actions taken on behalf of Company or of its Subsidiaries, (Athe MCC Business) has been assessed a civil monetary penalty under Section 1128A of the Social Security Act or any regulations promulgated thereunder, (B) has been excluded from participation that is licensed in any federal health care program or state health care program (as such terms are defined by the Social Security Act), (C) has been convicted of any criminal offense relating to the delivery of any item or service under a federal health care program or (D) is a party to or subject to any action or proceeding concerning any of the matters described above in clauses (A) and (C). (iv) Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on Company, each of Company’s insurance and health maintenance Subsidiaries meets the requirements for participation in, and receipt of payment from, the Medicaid and Medicare Advantage programs in which it participates and is a party to one or more valid agreements with the applicable state Medicaid agencies and CMSjurisdictions as an insurance company, as applicablehealth maintenance organization (including a single healthcare service plan), authorizing its participationmanaged care organization, healthcare service plan, specialized healthcare service plan, healthcare service corporation, pharmacy, dental maintenance organization, dental plan organization, prepaid dental plan, third party administrator, pharmacy benefit administrator, and/or utilization review agent, broker or agency.

Health Care Regulatory Compliance. (i) Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on Company, Company and its Subsidiaries are, and Company and its Subsidiaries’ ' businesses are being conducted, in compliance with the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191), as amended by the Health Information Technology for Economic and Clinical Health Act (Pub. L. No. 111-5), any implementing regulations and any state medical information Laws applicable to the business of Company or its Subsidiaries (collectively, the “"Privacy Laws”"). (ii) Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on Company, Company and each of its Subsidiaries, and to the Knowledge of Company, all of their respective directors, officers, agents and employees, are in compliance with, and Company and each of its Subsidiaries have compliance programs including policies and procedures reasonably designed to cause Company and its Subsidiaries and their respective directors, officers, agents and employees to be in compliance with, to the extent applicable, all Health Care Laws. Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on Company, no third-party payment program has imposed a fine, penalty or other sanction on Company or its Subsidiaries and none of Company or its Subsidiaries has been excluded or suspended from participation in any such program. (iii) Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on Company, neither Company, any of its Subsidiaries, nor to the Knowledge of Company, any director or executive officer of Company or any of its Subsidiaries, with respect to actions taken on behalf of Company or of its Subsidiaries, (A) has been assessed a civil monetary penalty under Section 1128A of the Social Security Act or any regulations promulgated thereunder, (B) has been excluded from participation in any federal health care program or state health care program (as such terms are defined by the Social Security Act), (C) has been convicted of any criminal offense relating to the delivery of any item or service under a federal health care program or (D) is a party to or subject to any action or proceeding concerning any of the matters described above in clauses (A) and (C). (iv) Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on Company, each of Company’s 's insurance and health maintenance Subsidiaries meets the requirements for participation in, and receipt of payment from, the Medicaid and Medicare Advantage programs in which it participates and is a party to one or more valid agreements with the applicable state Medicaid agencies and CMS, as applicable, authorizing its participation.

Health Care Regulatory Compliance. (ia) Except as set forth on Section 3.21(a) of the Company Disclosure Schedule, the Company and each of its Subsidiaries have all required licenses, permits, certificates, approvals, variances, registrations, accreditations, permissions and billing and other authorizations (collectively, “Permits”) necessary for the conduct of their respective businesses and the use of their properties and assets as presently conducted and used, and the Company’s and its Subsidiaries’ respective employees and agents have all Permits necessary for the conduct of their professional activities, and all such Permits are in full force and effect, except where the failure to have such Permits has not and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect Effect. Except as set forth on CompanySection 3.21(a) of the Company Disclosure Schedule, the Company and each of its Subsidiaries arehave had at all times during the previous three (3) years all required Permits necessary for the conduct of their respective businesses and the use of their properties and assets as conducted and used at such respective times, except where the failure to have such Permits has not had and Company and its Subsidiaries’ businesses are being conducted, in compliance with the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191), as amended by the Health Information Technology for Economic and Clinical Health Act (Pub. L. No. 111-5), any implementing regulations and any state medical information Laws applicable to the business of Company or its Subsidiaries (collectively, the “Privacy Laws”). (ii) Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect on Effect. The Company, Company ’s and each of its Subsidiaries, and to ’ respective employees have had at all times during the Knowledge of Company, previous three (3) years all Permits necessary for the conduct of their professional activities at such respective directorstimes, officers, agents except where the failure to have such Permits has not and employees, are in compliance with, and Company and each of its Subsidiaries have compliance programs including policies and procedures reasonably designed to cause Company and its Subsidiaries and their respective directors, officers, agents and employees to be in compliance with, to the extent applicable, all Health Care Laws. Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect Effect. Except as set forth on CompanySection 3.21(a) of the Company Disclosure Schedule, no third-party payment program has imposed a fine, penalty or other sanction on neither the Company or its Subsidiaries and none nor any of Company or its Subsidiaries has been excluded received written notice within the previous three (3) years from any Governmental Authority with respect to any Permit that such Permit is subject to revocation, suspension, or suspended from participation in any other disciplinary or adverse administrative action by any Governmental Authority, except where such program. (iii) Except as revocation, suspension, or any other disciplinary or adverse administrative action has not and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect on Company, neither Company, any Effect. (b) The Company and each of its Subsidiaries, nor Subsidiaries are and during the previous three (3) years have been in compliance with all Health Care Laws and the terms of all Permits to the Knowledge of Company, any director or executive officer of extent applicable to the Company or any of its Subsidiaries, or any of its or their respective businesses or operations, except where the failure to comply has not and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. Except as set forth on Section 3.21(b) of the Company Disclosure Schedule, within the previous three (3) years, neither the Company nor any of its Subsidiaries has received any written notice alleging any failure to comply with respect any of the Health Care Laws, except where such failure to actions taken comply has not and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (c) Set forth on behalf Section 3.21(c) of the Company Disclosure Schedule are the entities which have developed the plan (the “Compliance Plan”) for maintaining compliance with all Health Care Laws applicable to the Company and its Subsidiaries that have been passed or adopted prior to the date of this Agreement, except where the failure to comply has not and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. The entities set forth on Section 3.21(c) of the Company Disclosure Schedule currently implement the provisions of the Compliance Plan to assist in ensuring that the Company and each of its Subsidiaries will be in compliance with such Health Care Laws at such time as they become applicable to the Company or its Subsidiaries, except where such failure to be in compliance has not and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (d) Except as set forth on Section 3.21(d) of the Company Disclosure Schedule, neither the Company nor any of its Subsidiaries, (A) nor any of the Company’s or its Subsidiaries’ current directors or officers, is currently, or has been at any time since January 1, 2006: (i) excluded from participation in any Federal Health Care Program or state health care program, (ii) convicted of, charged with, or under investigation for or related to any criminal offense in respect of any Health Care Law (including offenses relating to the delivery of any item or service under a federal health care program relating to the distribution, prescription, or dispensing of a prescription drug, controlled substance or medical equipment), (iii) convicted of, charged with, or under investigation for or related to any criminal or civil offense under 42 U.S.C. §§ 1320a-7, 1320a-7a, 1320a-7b, or 1395nn, or 31 U.S.C. § 3729 et seq., under any parallel state Laws, or the regulations promulgated pursuant to such statutes and Laws, but has not yet been excluded, debarred, suspended, or otherwise declared ineligible, (iv) debarred or disqualified from participation in regulated activities for any violation or alleged violation of any Health Care Law, (v) listed on the General Services Administration List of Parties Excluded from Federal Programs, including the Office of Inspector General’s List of Excluded Individuals/Entities, (vi) assessed a civil monetary money penalty under Section 1128A of the Social Security Act or any regulations promulgated thereunder, (Bvii) has been excluded from participation in any federal health care program had his or state health care program (as such terms are defined by the Social Security Act)her professional license, Drug Enforcement Agency number, or Medicare or Medicaid provider status, relinquished, terminated or revoked, (Cviii) has been convicted of sanctioned, disciplined, or investigated by any criminal offense relating to the delivery of licensing board or any item federal, state, or service under local society, agency, regulatory body, governmental authority, hospital, third-party payor or specialty board, (ix) had a federal health care program final judgment or settlement entered against him or her in connection with a malpractice, professional negligence or similar action, or (Dx) is a party to or subject to, or threatened to be made a party to or subject to, any action or proceeding concerning any of the matters described above in clauses (Ai) through (ix), except, in each case as applicable, where such exclusion, conviction, disbarment, disqualification, suspension, listing, assessment, sanction, disciplinary action, investigation, judgment, settlement, action or proceeding has not and (C). (iv) Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect Effect. Except as set forth on CompanySection 3.21(d) of the Company Disclosure Schedule, neither the Company nor any of its Subsidiaries nor any of their respective current directors or officers has, since January 1, 2006, received any requests for information or subpoenas in connection with violations or potential violations of any of the Health Care Laws, except where such violation has not and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (e) Except as set forth on Section 3.21(e) of the Company Disclosure Schedule, the Company and each of Company’s insurance its Subsidiaries are: (i) in compliance with all applicable Laws relating to the operation of pharmacies and health maintenance Subsidiaries meets medical equipment suppliers, the requirements for participation inrepackaging of drug products, the wholesale distribution of prescription drugs, controlled substances, and receipt medical equipment, and the dispensing of payment fromprescription drugs, controlled substances, and medical equipment, except where the failure to so comply has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect; (ii) in compliance with all applicable Laws relating to the labeling, packaging, advertising, marketing, distribution or adulteration of prescription drugs, controlled substances, and medical equipment, except where the failure to so comply has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect; and (iii) not subject to any sanction or other adverse action by any Governmental Authority for the matters described in this Section 3.21(e), except where such sanction or adverse action has not and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect (f) The Company and each of its Subsidiaries are in compliance with all applicable Laws, including all Health Care Laws, governing marketing or promotional activities, including, without limitation, requirements administered by the Federal Trade Commission, the Federal Communications Commission, the U.S. Department of Health and Human Services Office of Inspector General, the Centers for Medicare and Medicaid Services, and Medicare Advantage programs other federal and state regulatory agencies such as “do not call” and “do not fax” registries, except where the failure to comply has not had and would not have, individually or in which it participates and is the aggregate, a party to one or more valid agreements with the applicable state Medicaid agencies and CMS, as applicable, authorizing its participationCompany Material Adverse Effect.