Health Care Regulatory Compliance Sample Clauses

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, ...

Health Care Regulatory Compliance. (i) Except as set forth in Section 3.1(w) of the Clearday Disclosure Letter, the Clearday is operating and since January 1, 2018, have operated in compliance with the Health Care Regulatory Laws, except where any such non-compliance would not reasonably be expected to have a Material Adverse Effect. Except as set forth in Section 3.1(w) of the Clearday Disclosure Letter, neither Clearday nor or any Affiliate thereof has during such period received any written or, to Clearday’s Knowledge, oral notice, nor any written or, to Clearday’s Knowledge, oral complaints from a Person, that allege that Clearday is not in compliance with any such Health Care Regulatory Laws and that have not been addressed to the satisfaction of such Governmental Entity or complainant, except where the failure to be in compliance would not be expected to result in a Material Adverse Effect. (ii) Except as set forth in Section 3.1(w) of the Clearday Disclosure Letter, since January 1, 2018, Clearday and its executive employees and agents have not, to Clearday’s Knowledge, been excluded, debarred, suspended or been otherwise determined to be, or identified as, ineligible to participate in the Programs, or convicted of any crime relating to any such Program, nor have Clearday or any Affiliate thereof received any written notice that Clearday or any Affiliate thereof, their employees or, as applicable, workforce members have been convicted of any crime relating to a Program, nor proposed to be excluded, debarred, suspended or otherwise determined to be, or identified as, ineligible to participate in any such Program. Except as set forth in Section 3.1(w) of the Clearday Disclosure Letter, since January 1, 2018, to Clearday’s Knowledge, none of Clearday or any Affiliate thereof has received any written notice that any of them is the subject of any investigation or review regarding its participation in any Program. (iii) Except as set forth in Section 3.1(w) of the Clearday Disclosure Letter, Clearday and its Affiliates have not, since January 1, 2018, been the subject of or received, or have knowledge of any pending or, to Clearday’s Knowledge, overtly threatened: (i) compliance, disciplinary or enforcement Action from any Governmental Entity; (ii) any written notice of noncompliance with or alleged violation of any Health Care Regulatory Laws or permits required under such laws; or (iii) material finding from an inspection by a Governmental Entity. Except as set forth in Section 3.1(w) of...

Health Care Regulatory Compliance. (a) Except as set forth in Schedule 2.27(a) of the Company Schedules, the Company and each Subsidiary is operating and has operated in material compliance with the Health Care Regulatory Laws. Except as set forth in Schedule 2.27(a) of the Company Schedules, neither the Company, any Subsidiary, or any Affiliate thereof has received any written or oral notice or complaint from a Governmental Entity or any other Person, that allege that the Company or such Subsidiary is not in compliance with any such Health Care Regulatory Laws and that have not been addressed to the satisfaction of such Governmental Entity or complainant. (b) Neither the Company nor any Subsidiary, or its or their officers or directors, nor, to the Company’s knowledge, any employees or independent contractors of the Company or the Subsidiary, has been excluded, debarred, or suspended from, or otherwise determined to be or identified as ineligible to participate in, any Health Care Program, or convicted of any crime relating to any Health Care Program, and the Company has not received, and to the Company’s knowledge, no officer, director, employee, or independent contractor of the Company has received, any written notice that the Company or such Subsidiary is the subject of any investigation or review regarding its participation in any Health Care Program. Neither the Company nor any Subsidiary, or its or their officers or directors, nor, to the Company’s knowledge, any employees or independent contractors of the Company or such Subsidiary is listed on the Office of Inspector General’s exclusion list, the General Services Administration’s Lists of Parties Excluded from Federal Procurement and Non-procurement Programs, any state Medicaid exclusion list, or similar lists in any jurisdiction in which the Company or a Subsidiary operates. (c) Neither the Company nor any Subsidiary has been the subject of or received, or has knowledge of any pending or, to the Company’s knowledge, threatened: (i) compliance, disciplinary or enforcement action from any Governmental Entity; (ii) any written notice of noncompliance with or alleged violation of any Health Care Regulatory Laws; or (iii) material finding from an inspection by a Governmental Entity. No Person has filed or, to the Company’s knowledge, has threatened to file against the Company or any Subsidiary any claim under any federal or state whistleblower statute, including without limitation, the Federal False Claims Act (31 U.S.C. §§ 3729 et seq...

Health Care Regulatory Compliance. Without limiting the provisions of Section 5.9: (a) Except as set forth on Schedule 5.22(a) of the Company Disclosure Schedule, each of the Company and its Subsidiaries has all Company 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 Company Permits necessary for the conduct of their professional activities, and all such Company Permits are in full force and effect. The Company and each of its Subsidiaries have had at all times during the previous three years all Company 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. The Company’s and its Subsidiaries’ respective employees have had at all times during the previous three years all Company Permits necessary for the conduct of their professional activities at such respective times. Neither the Company nor any of its Subsidiaries has received written notice from any Governmental Authority, nor does the Company have Knowledge, that any Company Permit is subject to revocation, suspension, or any other disciplinary or adverse administrative action by any Governmental Authority. No Company Permit applicable to the Company or any of its Subsidiaries is subject to a consent order or any other final adverse disciplinary or administrative action, any of which is still in force and effect. The consummation of the Offer and the Merger will not cause the revocation or cancellation of any Company Permit. (b) Each of the Company and its Subsidiaries is in material compliance with all Health Care Laws and the terms of all Company Permits to the extent applicable to the Company or any of its Subsidiaries, or any of its or their respective businesses or operations. (c) The Company and its Subsidiaries are in compliance in all material respects with all requirements of the Food and Drug Administration (“FDA”), or any other Governmental Authority engaged in the regulation of the Company’s or its Subsidiaries’ products, including but not limited to FDA’s requirements pertaining to establishment registration, product listing, manufacturing (i.e., cGMPs/QSR), labeling and advertising and promotion, adverse event reporting and record keeping and reporting requirements. (d) Neither the Company nor any of its Subsidiaries is currently, or has been at any ti...

Health Care Regulatory Compliance. (a) Except as set forth in Schedule 3.20(a), the Company Parties are operating and since January 1, 2015, have operated in compliance in all material respects with the Health Care Regulatory Laws. Except as set forth in Schedule 3.20(a), none of the Company Parties or any Affiliate thereof has during such period received any written or, to the Company Parties’ Knowledge, oral notice, nor any written or, to the Company Parties’ Knowledge, oral complaints from a Person, that allege that any Company Party is not in compliance in a material respect with any such Health Care Regulatory Laws and that have not been addressed to the satisfaction of such Governmental Authority or complainant. (b) The Company Parties are not, and have not at any time, enrolled as a participating provider or supplier in, or received payments for professional or medical services from, any Program. Except as set forth in Schedule 3.20(b), since January 1, 2015, the Company Parties and their employees and agents have not been excluded, debarred, suspended or been otherwise determined to be, or identified as, ineligible to participate in the Programs, or convicted of any crime relating to any such Program, nor have the Company Parties or any Affiliate thereof received any written notice that a Company Party, their employees or, as applicable, workforce members have been convicted of any crime relating to a Program, nor proposed to be excluded, debarred, suspended or otherwise determined to be, or identified as, ineligible to participate in any such Program. Except as set forth in Schedule 3.20(b), since January 1, 2015, to Company Parties’ Knowledge none of the Company Parties or any Affiliate thereof has received any written notice that any of the Company Parties is the subject of any investigation or review regarding its participation in any Program. None of the Company Parties is, as of the date hereof, listed on the System for Award Management or the OIG lists of excluded individuals and entities. (c) Except as set forth in Schedule 3.20(c), the Company Parties have not, since January 1, 2015, been the subject of or received, or to the Company Parties’ Knowledge, is there any pending or threatened: (i) compliance, disciplinary or enforcement Action from any Governmental Authority; (ii) any written notice of noncompliance with or alleged violation of any Health Care Regulatory Laws or Regulatory Filings; or (iii) material finding from an inspection by a Governmental Authority. Except ...

Health Care Regulatory Compliance. (a) Parent and the Parent Subsidiaries are, and since January 1, 2013 have been, in compliance with all health care or insurance Laws to the extent applicable to the operations, activities or services of Parent and the Parent Subsidiaries and orders pursuant to such Laws applicable to Parent, any Parent Subsidiary or any assets owned or used by them, including all Laws relating to: (i) the licensure, certification, qualification or authority to transact business in connection with the provision of, payment for, or arrangement of, health benefits or health insurance, including Laws that regulate managed care, third-party payors and persons bearing the financial risk for the provision or arrangement of health care services and, without limiting the generality of the foregoing, Laws relating to Parent’s and the Parent Subsidiaries’ participation in the Programs; (ii) the solicitation or acceptance of improper incentives involving persons operating in the health care industry, including Laws prohibiting or regulating fraud and abuse, patient referrals or Provider incentives generally or under the following statutes: the Federal anti-kickback Law (42 U.S.C. § 1320a-7b) and the regulations promulgated thereunder, the Xxxxx Laws (42 U.S.C. § 1395nn) and the regulations promulgated thereunder, the Federal False Claims Act (31 U.S.C. §§ 3729, et seq.), the Federal Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Federal Program Fraud Civil Remedies Act (31 U.S.C. § 3801 et seq.) and the Federal Health Care Fraud Law (18 U.S.C. § 1347); (iii) the administration of health care claims or benefits or processing or payment for health care services, treatment or supplies furnished by Providers, including third party administrators, utilization review agents and persons performing quality assurance, credentialing or coordination of benefits; (iv) xxxxxxxx to insurance companies, health maintenance organizations and other managed care plans, claims for reimbursement or otherwise related to insurance fraud and abuse; (v) the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended; (vi) any Laws governing the privacy, security, integrity, accuracy, collection, use, transmission, storage or other protection of information about or belonging to actual or prospective participants in Parent’s Programs, including the Health Insurance Portability and Accountability Act; and (vii) any Health Care Law, and has not since January 1, 2013 received any notice from any...

Health Care Regulatory Compliance. (a) Neither the Company nor any Subsidiary of the Company other than the SSOA Subsidiary bills any commercial insurance plan or any health care program administered or funded, in whole or in part, by the government of the United States of America, including Medicare, Medicaid and TRICARE programs (described in Title XVIII of the United States Social Security Act (the “SSA”), Title XIX of the SSA, and Title 10, Chapter 55 of the U.S.C., respectively (collectively, “Federal Health Care Programs”) for any item or service. The Company has provided to the Buyer access to complete and accurate copies of all Medicare, Medicaid and other Federal Health Care Program provider agreements, and access to a complete and accurate list of all related provider numbers, of the SSOA Subsidiary. (b) The SSOA Subsidiary is qualified for participation in Medicare, Medicaid and TRICARE and the SSOA Subsidiary is party to provider agreements for such programs which are in full force and effect with no material events of default having occurred thereunder. The SSOA Subsidiary has, in all material respects, timely filed all claims or other reports required to be filed with respect to the purchase of items or services by third-party payors, including Federal Health Care Programs (collectively, “Payors”). All such claims or reports are complete and accurate in all material respects. The SSOA Subsidiary has paid or has properly recorded on its financial statements all actually known and undisputed refunds, discounts or adjustments which have become due pursuant to such claims, and the SSOA Subsidiary does not have any material liability to any Payor with respect thereto, except as has been reserved for in the SSOA Subsidiary’s financial statements or disclosed in the Company Disclosure Letter. There are no pending appeals, overpayment determinations, adjustments, challenges, audits, litigation, or notices of intent to reopen Federal Health Care Program claims determinations or other reports required to be filed by the SSOA Subsidiary in order to be paid by a Payor for services rendered or items supplied. (c) Except as would not reasonably be expected to have a Company Material Adverse Effect, neither the Company nor any of its Subsidiaries, nor any officer, director, managing employee or agent (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company or any of its Subsidiaries, nor any distributor of the Company’s or its Subsidiaries’ products (with respect to such products...

Health Care Regulatory Compliance. With respect to this Section 3.13(b)(i), except as would not result in a Company Material Adverse Effect: The Company and each Subsidiary have conducted, and are presently conducting, its Facilities and other businesses so as to comply with all Legal Requirements applicable to the conduct of operation of such Facilities and other businesses. The Company and each Subsidiary are in compliance with the statutes and regulations related to fraud, abuse, false claims/statements, referrals and prohibition of kickbacks. The Company and each Subsidiary have complied with all applicable billing policies, procedures, limitations and restrictions of Third Party Payor Programs (as defined below). There are no Reimbursement Source Obligations (as defined below) of the Company and the Subsidiaries other than those recorded or reserved on the Financial Statements. Each cost report and other required claims and filings with Governmental Authorities with respect to Medicare and each state Medicaid program in which they participate, required to be filed by or on behalf of the Company or any Subsidiary prior to the Effective Time, has been or will have been timely prepared and filed in accordance with applicable Legal Requirements. To the Company's knowledge, all of such filings were, when filed or as amended, true and complete. The Company and each Subsidiary have available for inspection by Purchaser prior to the date of this Agreement each such filing since May 13, 2002.

Health Care Regulatory Compliance. (a) The Company and each of its Affiliates and, to the knowledge of the Company, each of the Managed Practices, are in compliance with Sections 1128A, 1128B, or 1877 of the Social Security Act (42 U.S.C. §§ 1320a-7a, 1320a-7b, and 1395nn), 31 U.S.C. § 3729 et seq. (the Civil False Claims Act), 18 U.S.C. § 1347 (Health Care Fraud), Public Law 104-191 (the Health Insurance Portability and Accountability Act of 1996), all fraud and abuse, false claims and anti-self referral Laws and all Laws related to the confidentiality, privacy and security of medical information, or to licensing, the corporate practice of medicine, fee-splitting, certificate of need and reimbursement or billing for healthcare services (collectively, “Health Care Laws”), except where the failure to comply would not reasonably be expected, individually or in the aggregate, to have an adverse affect equal to or greater than 2.5% of the revenues, EBITDA or assets of the Company and its Subsidiaries, taken as a whole. The Company and each of its Affiliates have timely and accurately filed all material reports, data and other information required to be filed with any Governmental Entity, including with respect to obtaining or maintaining any Company Permit. (b) The Company has disclosed to Parent any and all corporate integrity or other agreements with any Governmental Entity which apply to the Business. The Company and each of its Affiliates are in material compliance with all such agreements. No employee or independent contractor of the Business (whether an individual or entity), or any physician performing services related to the Business is excluded from participating in the Medicare, Medicaid, TRICARE or any other federal or state governmental health care program, including those as defined in 42 U.S.C. §1320a-7b(f). (“Programs”) nor to the Company’s knowledge is any such exclusion threatened or pending. None of the officers, directors, agents or managing employees (as such term is defined in 42 U.S.C. § 1320a-5(b)) of the Company or its Affiliates has been excluded from the Programs, been subject to sanction pursuant to 42 U.S.C. § 1320a-7a or 1320a-8, or been convicted of a crime described at 42 U.S.C. § 1320a-7b, nor is any such exclusion, sanction or conviction threatened or pending, except where such exclusion, sanction or conviction would not reasonably be expected, individually or in the aggregate, to have an adverse affect equal to or greater than 2.5% of the revenues, EBITDA or as...

Health Care Regulatory Compliance. (a) The Company and each of its Subsidiaries is in compliance with all applicable Laws, including Laws relating to Medicare, Medicaid, confidentiality of health information, and third-party billing functions performed on behalf of health care providers. Since October 1, 1999, none of the Company, its Subsidiaries or any of their respective officers, directors, employees, or, to the Company’s Knowledge, agents, consultants, or any other person acting on behalf of the Company or a Subsidiary, has been charged with or, to the Knowledge of the Company, is now under investigation with respect to, a violation of any applicable Law. None of the Company, its Subsidiaries or any of their respective employees, agents or consultants, or any other person acting on behalf of the Company or a Subsidiary is a party to, or bound by, any order or corporate integrity agreement with any Governmental Entity. (b) In connection with claims submitted in connection with their provision of third-party billing services and business outsourcing services, the Company and each of the Subsidiaries, since October 1, 1999, have prepared and filed all claims with Medical Reimbursement Programs in accordance with all Laws and other requirements applicable to the Medical Reimbursement Programs. For purposes of this Agreement, “Medical Reimbursement Programs” means all private, commercial and governmental health care reimbursement programs, including Federal Health Care Programs and “Federal Health Care Programs” has the meaning given in Section 1128B(f) of the Social Security Act and includes the Medicare, Medicaid and TRICARE programs.