Healthcare Regulatory Matters. (a) Each of Parent and its Subsidiaries and, to the Knowledge of Parent, their respective directors, officers, employees and agents are, and at all times within the last three (3) years have been, in compliance with all applicable Healthcare Laws, except where such non-compliance would not, individually or in the aggregate, reasonably be expected to be material to the Parent, taken as a whole. In the past three (3) years, neither Parent nor any of its Subsidiaries has received any written notification, correspondence or any other communication from the FDA or any other Governmental Authority asserting non-compliance by, or liability of, Parent or any of its Subsidiaries under any applicable Healthcare Laws, except where such non-compliance would not, individually or in the aggregate, reasonably be expected to be material to Parent and its Subsidiaries, taken as a whole. Neither Parent nor any of its Subsidiaries is a party to nor has any ongoing reporting obligations pursuant to or under any Order by a Governmental Authority or corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Authority.
(b) All clinical or preclinical studies, tests or trials that have been or are being conducted by or on behalf of, or sponsored by, Parent and its Subsidiaries, or in which Parent’s or its Subsidiaries’ products or product candidates have participated, and which have been submitted to the FDA or other Governmental Authority in connection with applications for authorizations from any Governmental Authority, were and, if still pending, are being conducted in compliance in all material respects with all applicable Healthcare Laws. No investigational new drug application filed with or submitted to the FDA or comparable application submitted to any other Governmental Authority by or on behalf of Parent or any of its Subsidiaries has been terminated or suspended, and neither the FDA nor any applicable Governmental Authority or institutional review board has commenced, or to the Knowledge of Parent, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of Parent or any of its Subsidiaries.
(c) To the Knowledge of Parent, neither Parent nor any of its Subsidiaries, nor, any d...
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. Whe...
Healthcare Regulatory Matters. Except as (i) otherwise disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus or (ii) would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company and each subsidiary is in compliance with all Healthcare Laws (as defined below) applicable to the business of the Company, relating to the compounding, development, manufacturing, labeling, advertising, promotion, storage and distribution of drug products and medical devices, or the operation or management of home and outpatient infusion centers, pharmacy, patient healthcare information, patient abuse, and the quality and adequacy of infusion or other medical care, including without limitation: (a) federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the Sxxxx Law (42 U.S.C. §1395nn), the Civil False Claims Act (31 U.X.X. §0000 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the civil monetary penalty laws (42 U.S.C. § 1320a-7a), the exclusion laws (42 U.S.C. § 1320a-7), and any similar state laws or regulations, (b) 42 U.S.C. §§ 1395-1395lll (the Medicare Act), (c) Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396w-5 (the Medicaid Act), (d) the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and all regulations promulgated thereto, (e) the Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), (f) the Public Health Service Act (42 U.S.C. § 201 et. seq.), (g) the Controlled Substances Act (21 U.S.C. § 801 et seq.), and any comparable healthcare laws, regulations each of (a) through (g) as may be amended from time to time, and the regulations promulgated thereto (collectively, “Healthcare Laws”). Neither the Company nor any subsidiary is subject to material civil penalties, or mandatory or permissive exclusion from any state or federal healthcare program, including Medicare, Medicaid, TRICARE, CHAMPVA, any state health plan adopted pursuant to Title XIX of the Social Security Act (collectively, “Governmental Program”). Without limiting the generality of the foregoing, neither the Company or any subsidiary has received written notice by a Governmental Authority of any material violation (or of any action, litigation, arbitration, claim, demand, investigation, audit, charge, or formal inquiry (“Proceeding”) involving allegations of any material violation) of any applicable Healthcare La...
Healthcare Regulatory Matters. (a) The Loan Parties hold, and are operating in compliance with, such material permits, registrations, licenses, franchises, approvals, authorizations and clearances of the FDA, if any, required for the conduct of their business as currently conducted (collectively, the “FDA Permits”), and all such FDA Permits, if any, are in full force and effect. The Loan Parties have fulfilled and performed, in all material respects, all of their obligations with respect to the FDA Permits, and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other impairment of the rights of the holder of any FDA Permit.
(b) The Loan Parties, and to the knowledge of the Loan Parties, each of their licensed employees and contractors, are in compliance with all applicable Healthcare Laws, to the extent failure to do so could not reasonably be expected to have a Material Adverse Effect. Except as disclosed to the Administrative Agent from time to time pursuant to Section 6.03, the Loan Parties have not received notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, inspection, investigation, arbitration or other action from the FDA or any other applicable Governmental Authority or applicable foreign regulatory agency with jurisdiction over the Loan Parties, alleging that any operation or activity of the Loan Parties is in violation of any applicable Healthcare Law, in each case, which would reasonably be expected to have a Material Adverse Effect on the Borrower and its Subsidiaries taken as a whole.
(c) All applications, notifications, submissions, information, claims, reports and statistics, and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for a FDA Permit or other permit or license from the FDA or other Governmental Authority with jurisdiction over the Loan Parties and relating to the Loan Parties, their business and their products, when submitted to the FDA or other Governmental Authority were true, complete and correct in all material respects as of the date of submission and any necessary or required material updates, changes, corrections or modification to such applications, submissions, information and data have been timely submitted to the FDA or other Governmental Authority.
(d) Except as set forth on Schedule 5.21 to the Disclosure Letter, since September 30, 2015, the Loan Parties...
Healthcare Regulatory Matters. (a) No Seller Party, Sherman Oaks, or, to the Knowledge of any Seller Party, any Physiciax, Xxxxice Provider or other Person rendering services (including directly or indirectly referring patients) to or at, or in any way affiliated with the Hospital (i) is a party to, or has received notice of, the commencement of any investigation or debarment proceedings or any governmental investigation or action (including any civil investigative demand or subpoena) under the False Claims Act (31 U.S.C. Section 3729 et seq.), the Anti-Kickback Act of 1986 (41 U.S.C. Section 51 et seq.), the Federal Health Care Programs Anti-Kickback statute (42 U.S.C. Section 1320a-7a(b)), the Ethics in Patient Referrals Act of 1989, as amended (Stark Law) (42 U.S.C. 1395nn), the Civil Money Penalties Law (42 U.S.X. Xection 1320a-7a), or the Truth in Negotiations (10 U.S.C. Section 2304 et seq.), Health Care Fraud (18 U.S.C. 1347), Wire Fraud (18 U.S.C. 1343), Theft or Embezzlement (18 U.S.C. 669), False Statements (18 U.S.C. 1001), False Statements (18 U.S.C. 1035), and Patient Inducement Statute and equivalent state statutes or any rule or regulation promulgated by a Governmental Entity with respect to any of the foregoing (collectively, the "Healthcare Fraud Laws") affecting any Seller Party, Sherman Oaks, the Hospital or the Business (and no grounds for any sxxx xxxceeding, investigation or action exist); and (ii) is not in full compliance with all applicable Healthcare Fraud Laws.
(b) Except as set forth on SCHEDULE 4.12, no Seller Party, Sherman Oaks, or, to the Seller Parties' Knowledge, any Physician, Sxxxxxx Provider or other Person rendering services (including directly or indirectly referring patients) to or at, or in any way affiliated with, the Hospital, has ever been investigated, charged or implicated in any violation of any state or federal statute or regulation involving false, fraudulent or abusive practices relating to participation in state or federally sponsored reimbursement programs, including, but not limited to, false or fraudulent billing practices. No Seller Party, Sherman Oaks or, to the Seller Parties' Knowledge, any Physician, Sexxxxx Xrovider or other Person rendering services (including directly or indirectly referring patients) to or at, or in any way affiliated with, the Hospital, has ever engaged in any of the following: (i) knowingly and willfully making or causing to be made a false statement or representation of a material fact in any applications...
Healthcare Regulatory Matters. (a) Except as does not constitute a Parent Material Adverse Effect, since the Applicable Date, (i) all Health Care Submissions required to be filed or maintained with or furnished to the FDA or any other Healthcare Regulatory Authority by Parent or any of its Subsidiaries have been so filed, maintained or furnished, (ii) all such Health Care Submissions were complete and accurate and in compliance with all applicable Laws when filed (or were corrected in or supplemented by a subsequent filing), and (iii) neither Parent or any of its Subsidiaries nor, to the Knowledge of Parent, any officer, employee or agent of Parent or any of its Subsidiaries acting on its behalf or any clinical trial investigator conducting any clinical trial of a Product Candidate of Parent or any of its Subsidiaries (a “Parent Clinical Trial Investigator”) has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Healthcare Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Healthcare Regulatory Authority or committed any act, made any statement or failed to make any statement, in each case, related to the business of Parent or any of its Subsidiaries that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Healthcare Regulatory Authority to invoke any similar policy.
(b) Neither Parent or any of its Subsidiaries nor, to the Knowledge of Parent, any director, officer or employee of Parent or any of its Subsidiaries or any Parent Clinical Trial Investigator is or has been debarred pursuant to 21 U.S.C. § 335a (a) or (b).
(c) Except as does not constitute a Parent Material Adverse Effect, (i) all Product Candidates under development by or on behalf of Parent or any of its Subsidiaries have been researched, developed, tested, manufactured, handled, labeled, packaged, stored, supplied, distributed, imported and exported, as applicable, in compliance with all applicable Laws, (ii) all clinical trials conducted by or on behalf of Parent or any of its Subsidiaries have been conducted in compliance with applicable protocols, procedures and Laws, (iii) no Healthcare Regulatory Authority, institutional review board or ethics committee has commenced any action to place a clinical...
Healthcare Regulatory Matters. (a) The Company and SpinCo are, and have been since their formation, in compliance with all applicable Healthcare Laws, except where such failure to so comply would not reasonably be expected to materially and adversely impact the SpinCo Business. Neither the Company nor SpinCo has received any written notice from any Regulatory Authority alleging any material violation of any applicable Healthcare Law. To the Knowledge of the SpinCo Group, there are no Actions pending or threatened against the Company or any of its Subsidiaries (excluding SpinCo) (in each case solely with respect to the SpinCo Business) or SpinCo or any of the SpinCo Products or alleging any material violation by the Company, SpinCo, the SpinCo Business or the SpinCo Products of any such applicable Healthcare Law.
(b) Except as set forth in Section 5.24(b) of the SpinCo Disclosure Schedule, (i) SpinCo does not hold any Regulatory Authorization, and (ii) SpinCo does not have any application for a Regulatory Authorization pending with the FDA or any other applicable Regulatory Authority.
(c) Except as set forth in Section 5.24(c) of the SpinCo Disclosure Schedule, (i) the Company does not hold any Regulatory Authorization in relation to the SpinCo Business, and (ii) the Company, in relation to the SpinCo Business, does not have any application for a Regulatory Authorization pending with the FDA or any other applicable Regulatory Authority.
(d) None of the Company and its Subsidiaries or any person acting on behalf of any of the Company and its Subsidiaries has with respect to any SpinCo Product: (i) been subject to a shutdown or import or export prohibition imposed by any Regulatory Authority; or (ii) received any FDA Form 483, or other written notice of inspectional observations, “warning letters,” “untitled letters” or any similar written correspondence from any Regulatory Authority in respect of such Entity or its business operations, alleging or asserting material noncompliance with any applicable Healthcare Law or Regulatory Authorization. No Regulatory Authority has threatened such action.
(e) To the Knowledge of the SpinCo Group, neither SpinCo nor the Company has (i) made an untrue statement of a material fact or a fraudulent claim or statement to any Regulatory Authority with respect to the SpinCo Business or the SpinCo Products, (ii) failed to disclose a material fact required to be disclosed to any Regulatory Authority with respect to the SpinCo Business or the SpinCo Products or...
Healthcare Regulatory Matters. (a) CareOregon and each CareOregon Company is duly licensed and has all necessary Approvals to perform all of the services provided by CareOregon and such CareOregon Company.
(b) 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 CareOregon Business have been obtained and are in full force and effect, including, as applicable, the CCO Contract and approved provider status in any approved Third Party Payor Program in which CareOregon or any CareOregon Company participates (collectively, the “CareOregon Health Care Licenses”). CareOregon and the CareOregon Companies own and/or possess, and hold free from restrictions or conflicts with the rights of others, all such CareOregon Health Care Licenses.
(c) Except as set forth in Section 6.9(c) of the Disclosure Schedules,
(i) CareOregon and the CareOregon 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 Regulatory Authority having jurisdiction over the CareOregon Business, (ii) none of CareOregon or any of the CareOregon Companies is, nor has any such entity been in the past six (6) years, in material violation of any of the provisions of applicable Law with respect to health care service contractors or coordinated care organizations, and (iii) none of CareOregon or any of the CareOregon Companies, nor any Person acting on behalf of any such entity, has violated or has incurred any Liability under (A) any 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),
Healthcare Regulatory Matters. (a) Except as set forth on Schedule 2.12(a), the Company, HSW and MHM are, and have been since January 1, 2017, in material compliance with all applicable Health Care Laws.
(b) The Company, HSW and MHM do not presently participate in or submit claims to or have previously participated in or submitted claims to any Federal Health Care Program or Payor.
(c) Since January 1, 2017, none of the Company, HSW or MHM, and none of their current or previous officers, directors or employees, Company has been convicted of, formally charged with or, investigated for a Federal Health Care Program-related material offense or material violation of federal or state Law related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, or obstruction of an investigation of controlled substances, or has been debarred, excluded or suspended from participation in any Federal Health Care Program, for, or been subject to any order or consent decree of, or criminal or civil fine or penalty imposed by, any Governmental Body related to, fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, or obstruction of an investigation of controlled substances.
(d) To the extent required by applicable Laws, each of the Company Service Providers, HSW Service Providers and MHM Service Providers who provides, or the former health care professional who provided, in the past year, professional medical services (i) is (or was during such time s/he was providing services on behalf of the Company Group) a licensed healthcare provider who maintains, and during such time s/he was in the service of Company Group or MHM since January 1, 2014, maintained or has maintained, an active and unrestricted license in the state(s) in which s/he provides or provided such services on behalf of Company, HSW or MHM without being subject to any disciplinary or corrective action, and (ii) to the extent such Company Service Provider, HSW Service Provider or MHM Service Provider, or former health care professional, prescribes or prescribed controlled substances, has been or was at all relevant times validly registered with the United States Drug Enforcement Administration (“DEA”) under Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 U.S.C. § 801, et seq. (commonly known as the Controlled Substances Act).
(e) Except as set forth on Schedule 2.12(e), none of the Company, HSW or MHM, nor any Company Service Provider, HSW Service Pro...
Healthcare Regulatory Matters. (a) Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, each of the Company and its Subsidiaries holds all authorizations under applicable Healthcare Laws that are necessary for the lawful operation of the business of the Company and its Subsidiaries (such authorizations, the “Company Regulatory Permits”).
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the businesses of each of the Company and its Subsidiaries are being and, since January 1, 2014, have been conducted in compliance with (i) the FDCA; (ii) the Medicare program (Title XVIII of the Social Security Act), the Medicaid program (Title XIX of the Social Security Act) and the TRICARE program (10 U.S.C. §§ 1071, et seq.); (iii) the Physician Payments Sunshine Act; (iv) the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)) and the False Claims Act (42 U.S.C. § 1320a-7b(a)); (v) the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et. seq.), as amended by the Health Information Technology for Economic and Clinical Health Act; (vi) Section 501(k) of the Federal Trade Commission Act, as amended; (vii) any comparable foreign Laws with respect to matters relating to the provision, administration, promotion and/or payment of healthcare products or services that are applicable to the Company and its Subsidiaries; and (viii) the regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Healthcare Laws”)
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, since January 1, 2014, (i) all reports, documents, claims, permits, adverse event reports, notices, registrations and applications required to be filed, maintained or furnished to the FDA or any other Healthcare Regulatory Authority by the Company and its Subsidiaries have been so filed, maintained or furnished, and (ii) all such reports, documents, claims, permits, adverse event reports, notices, registrations and applications were complete and accurate on the date filed (or were corrected in or supplemented by a subsequent filing). Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, since January 1, 2014, neither the Company nor any of its Subsidiaries, nor, to the Knowledge of the Company, any officer, employee or ag...
