Health Regulatory Compliance. (a) The Community is being operated as a Residential Care Facility for the Elderly, as indicated on Schedule 1, having the number of beds or Residents as set forth on Schedule 1.
Health Regulatory Compliance. The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company that are described in, or the results of which are referred to in, the Registration Statement and the Prospectus were and, if still pending, are being conducted in all material respects in accordance with applicable local, state and federal laws, rules and regulations, including, but not limited to, the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations; each description of the results of such studies contained in the Registration Statement and the Prospectus is accurate in all material respects and fairly presents the data derived from such studies, and the Company is not aware of any other studies the results of which the Company believes reasonably call into question the study results described or referred to in the Registration Statement and the Prospectus; and except as disclosed in the Registration Statement and the Prospectus, neither the Company nor any Subsidiary has received any written notices or other written correspondence from the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency having jurisdiction over the Company or any of its properties (collectively, the “Regulatory Agencies”) requiring the termination, suspension or material adverse modification of any clinical trials that are described or referred to in the Registration Statement and the Prospectus; and the Company and the Subsidiaries have each operated and currently are in compliance with all applicable rules and regulations of the Regulatory Agencies except where the failure to be in compliance would not be expected reasonably to have a Material Adverse Effect.
Health Regulatory Compliance. (a) Each Seller described as being so certified on Schedule 5.32(a) is certified for participation in, and party to, valid provider agreements for payment by the Federal Medicare and all applicable state Medicaid programs (the “Government Programs”) for the provision of assisted living, Alzheimer’s care, skilled nursing, or home health care as reflected on Schedule 5.32(a). All Government Programs in which any Seller or any Seller Subsidiary has participated at any time during the last three years are listed on Schedule 5.32(a). True and complete copies of all such provider agreements shall have been furnished or made available to Purchaser during the Due Diligence Period. Each Seller and Seller Subsidiary is in good standing in each Government Program and any third party payor program. Except as set forth on Schedule 5.32(a), none of the Sellers or any Seller Subsidiary has any liabilities to any third party fiscal intermediary or carrier administering the Government Programs, directly to the Government Programs or any Governmental Entity, or to any other third party payor for the recoupment of any amounts previously paid to a Seller (or Seller Subsidiary) or any predecessor by any such third party fiscal intermediary, carrier, Government Program or other third party payor. There are no concluded or pending or, to the knowledge of the Sellers, threatened investigations, audits or other actions by any third party fiscal intermediary or carrier administering the Government Programs or any Governmental Entity, by the Department of Health and Human Services, any state Medicaid agency, intermediary or carrier or any third party payor, to recoup, set-off, or suspend payments to, or demand a refund from, or terminate the provider agreements with, or asserting any claim, demand, penalty, fine, or other sanction with respect to any of the activities, practices, policies or claims of, a Seller or any Seller Subsidiary, and there are no grounds to anticipate any such audit, investigation or action. Neither the Sellers nor any Seller Subsidiary has at any time since January 1, 2001 violated any condition for participation, or any rule, regulation, policy or standard of, any Government Program which has not, as of the date hereof, been satisfactorily cleared or resolved to the satisfaction of the Government Program, except for cited deficiencies the time for resolution of which has not yet passed. All Medicare Cost Reports for all periods since January 1, 2001 have be...
Health Regulatory Compliance. Except as would not reasonably be expected to have, individually or in the aggregate, a material effect on the Company or its subsidiaries, taken as whole, none of the Company, any of its subsidiaries or, to the Knowledge of the Company, any Company Partner has received any written notice or other communication from any Health Authority or any institutional review board (or ethics committee) (i) withdrawing or placing on “clinical hold” any Covered Product or otherwise suspending or terminating clinical research involving any Covered Product (ii) alleging any violation of any Health Law by the Company or any of its subsidiaries in connection with any Covered Product or (iii) threatening any regulatory enforcement action against the Company, any of its subsidiaries, or any Company Partner. Except as would not reasonably be expected to have, individually or in the aggregate, a material effect on the Company or its subsidiaries, taken as whole, the preclinical studies and clinical trials conducted by or at the direction of the Company and its subsidiaries with respect to any Covered Product were, and if still pending, are, being conducted in all respects in accordance with approved clinical protocols, informed consents, applicable requirements of the relevant Health Authorities and applicable requirements of good laboratory practices and good clinical practices, and to the Knowledge of the Company, there has not been any failure by any Company Partner to such conduct such preclinical studies and clinical trials in compliance with such applicable requirements, regulations and guidances. Except as would not reasonably be expected to have, individually or in the aggregate, a material effect on the Company or its subsidiaries, taken as whole, material regulatory authorizations related to any Covered Product are, in all respects, (i) in good standing and full force and effect and (ii) in compliance with all formal filing and maintenance requirements.
Health Regulatory Compliance. (1) Except as set forth on Schedule 3.1(w)(1), neither the Company nor any Company Subsidiary, nor to the knowledge of Sellers, any other Person (i) who has a direct or indirect ownership interest (as those terms are defined in 42 C.F.R. Section 1001.1001(a)(2)) in the Company or any Company Subsidiary, or (ii) who has an ownership or control interest (as defined in 42 C.F.R. Section 420.201) in the Company or any Company Subsidiary, or (iii) who is an officer, director, manager, agent (as defined in 42 C.F.R. Section 1001.1001(a)(2)) or managing employee (as defined in 42 C.F.R. Section 420.201) of the Company or any Company Subsidiary, or (iv) who has an indirect ownership interest (as that term is defined in 42 C.F.R. Section 1001.1001(a)(2)) in the Company or any Company Subsidiary, has knowingly engaged in any activities which are prohibited, or are cause for civil penalties or mandatory or permissive exclusion from Medicare, Medicaid, or any other State Health Care Program or Federal Health Care Program (as those terms are defined in 42 C.F.R. Section 1001.2) under 42 U.S.C. Sections 1320a-7, 1320a-7a, 1320a-7b, or 1395nn, or the regulations promulgated pursuant to such statutes, or related state or local/municipal statutes or which are prohibited by any private accrediting organization from which the Company seeks accreditation, including not having engaged in or experienced any of the following:
Health Regulatory Compliance. The Company’s and each of its subsidiaries’ business practices have been structured in a manner reasonably designed to comply with the state, federal and foreign Health Care Laws applicable to the Company and its subsidiaries respective businesses, and the Company and its subsidiaries are in compliance with such applicable Health Care Laws, except where the failure to do so would not reasonably be expected to have a Material Adverse Effect. The Company and its subsidiaries have not engaged in activities which to its knowledge are cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care program. For purposes of this Agreement, “Health Care Laws” means the: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. civil False Claims Act (31 U.S.C. Section 3729 et seq.), the federal criminal false claims law (42 U.S.C. § 1320a-7b(a)), the federal civil monetary penalties law (42 U.S.C. § 1320a-7a), the Xxxxx Law (42 U.S.C. §1395nn), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under HIPAA, the exclusion laws (42 U.S.C. §1320a-7), the statutes and regulations of applicable government healthcare programs, including the European Union General Data Protection Regulation (EU 2016 679), Medicare, Title XVIII of the Social Security Act, and Medicaid, Title XIX of the Social Security Act, and the regulations promulgated pursuant to such statutes; (iii) the U.S. federal Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (iv) the U.S. Controlled Substances Act; (v) the Clinical Laboratory Improvement Act; and (vi) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers. Nei...
Health Regulatory Compliance. (I) The Facility is being operated as an assisted living facility and memory care facility, having the number of beds or Residents as set forth on the Rent Roll.
Health Regulatory Compliance. (i) To the knowledge of the Company, each of the Subsidiaries that provides orthotic and/or prosthetic patient-care services (hereinafter “Patient Care Centers”) (a) is duly licensed to provide such services in every jurisdiction in which it conducts business, where such jurisdiction requires licensure of Patient Care Centers; and (b) has enrolled in and has received a supplier billing number from the Medicare program, the Medicaid program, the Indian Health Services program, the Tri-Care program and the Veterans Administration program (collectively referred to hereinafter as “Government Programs”). To the knowledge of the Company, in every jurisdiction in which a license or board certification is required as a condition of payment for services, each professional employee that performs orthotic and/or prosthetic patient-care services for a Subsidiary that provides orthotic and/or prosthetic patient-care services (hereinafter, a “Practitioner”) has the appropriate license or board certification in such jurisdiction. Neither the Company nor any Subsidiary (other than the Patient Care Centers) provides any patient care services that are material to the Company and its Subsidiaries, taken as a whole, and none of the Patient Care Centers provides any patient care services that are material to the Company and its Subsidiaries, taken as a whole, other than orthotic and/or prosthetic patient care services.
Health Regulatory Compliance. The Company’s and each of its subsidiaries’ business practices have been structured in a manner reasonably designed to comply with the state, federal and foreign Health Care Laws applicable to the Company and its subsidiaries respective businesses, and the Company and its subsidiaries are in compliance in all material respects with such applicable
Health Regulatory Compliance. (a) To Seller’s knowledge, no Resident fees are paid to Developed Land Seller by Medicare or Medicaid reimbursement. Developed Land Seller makes no representation or warranty herein with respect to any governmental assistance or third party payor program that may make any payment to any resident or such resident’s family (and not to Developed Land Seller). To Seller’s knowledge, Developed Land Seller has not received written notice that any action, proceeding, or investigation in connection with Medicare, Medicaid or other public or private third-party payor or other programs is pending or threatened against Developed Land Seller or any of Seller’s Affiliates in connection with the Community.
