Healthcare Regulatory Sample Clauses

Healthcare Regulatory. Except as would not reasonably be expected to be material to the Company and its Subsidiaries, taken as a whole: (a) Each of the Company and its Subsidiaries is, and has been for the past three (3) years, in compliance with all applicable Healthcare Laws. There are no Actions pending or, to the Knowledge of the Company and its Subsidiaries, threatened alleging non-compliance by Company, any of its Subsidiaries or Healthcare Professionals while acting on behalf or at the request of the Company or any of its Subsidiaries with respect to any such Healthcare Laws. During the past three (3) years, none of the Company, the Subsidiaries, or any Company Employee, has received written notice of any Action against the Company or any Subsidiary related to Healthcare Laws from any Governmental Entity. (b) Without limiting the generality of Section 4.20(a), currently, and for the past three (3) years: (i) Neither the Company nor any of its Subsidiaries, nor to the Knowledge of the Company, any officer, director, managing employee, agent (as those terms are defined in 42 C.F.R. § 1001.1001) or Healthcare Professional of the Company or any of its Subsidiaries or Company Employee: (i) is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal agreement with any Governmental Entity concerning compliance with Healthcare Laws; (ii) has been debarred, excluded or suspended from participation in any Federal or State Healthcare Program or excluded from participation in, or, within the past three (3) years subject to a formal disciplinary Action by, any Payor or Governmental Entity; (iii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 00, Xxxxxxx 0, xx xxx Xxxxxx Xxxxxx Code; or (iv) is currently listed on the U.S. General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs. (ii) The Company and each of its Subsidiaries has adopted a code of ethics and has an operational healthcare compliance program, covering and implementing the seven elements of an effective compliance program described in the Compliance Program Guidance published by the Office of Inspector General, U.S. Department of Health and Human Services, which governs all employees, including sales representatives and their interactions with their physician, Healthcare Professional and hospital customer...
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Healthcare Regulatory. (a) Sellers are qualified for participation in the Medicare and Medicaid programs. No Seller has received any notice indicating that such qualification may be terminated or withdrawn nor has any reason to believe that such qualification may be terminated or withdrawn. Sellers have timely filed all claims or other reports required to be filed with respect to the purchase of products or services by third-party payors (including, without limitation, Medicare and Medicaid), except where the failure to file such claims and reports would not, individually or in the aggregate, be reasonably likely to have a Material Adverse Effect, and all such claims or reports are complete and accurate in all material respects. Sellers have no material liability to any payor with respect thereto, except for liabilities incurred in the ordinary course of business consistent with past practice.
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Healthcare Regulatory. (a) Sellers are qualified for participation in the Medicare and Medicaid programs. No Seller has received any notice indicating that such qualification may be terminated or withdrawn nor has any reason to believe that such qualification may be terminated or withdrawn. Sellers have timely filed all claims or other reports required to be filed with respect to the purchase of products or services by third-party payors (including, without limitation, Medicare and Medicaid), except where the failure to file such claims and reports would not, individually or in the aggregate, be reasonably likely to have a Material Adverse Effect, and all such claims or reports are complete and accurate in all material respects. Sellers have no material liability to any payor with respect thereto, except for liabilities incurred in the ordinary course of business consistent with past practice. (b) Sellers have complied in all material respects with all applicable “Healthcare Laws”, i.e., The Social Security Act, as amended, Sections 1128, 1128A and 1128B, 42 U.S.C. Sections 1320a-7, 7(a) and 7(b), including, without limitation, Criminal Penalties Involving Medicare or State Health Care Programs, commonly referred to as the “Federal Anti-Kickback Statute” and The Social Security Act, as amended, Section 1877, 42 U.S.C. Section 1395nn (Prohibition Against Certain Referrals), commonly referred to as the “Xxxxx Statute,” the statute commonly referred to as the “Federal False Claims Act,” the Health Insurance Portability and Accountability Act of 1996, and the regulations issued pursuant thereto and all statutes and regulations relating to the possession, distribution, maintenance and documentation of controlled substances. (c) No personnel of the Sellers during such person’s employment with Sellers have been convicted of, charged with or investigated for a Medicare, Medicaid or other Federal Health Care Program (as defined in 42 U.S.C. § 1320a-7b(f)) related offense, or convicted of, charged with or investigated for a violation of federal or state law relating to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances. No personnel of the Sellers during such person’s employment with Sellers have been excluded or suspended from participation in Medicare, Medicaid or any other Federal Health Care Program, or have been debarred, suspended or are otherwise ineligible to participate in federal programs...
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Healthcare Regulatory. Section 2.18(a) Intellectual Property Used in the Business Section 4.01(a) Contracts or Commitments Section 4.14 Required Employees Process Section 5.05(a) Non-Solicitation of Employees
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Healthcare Regulatory. Except as set forth in Section 2.17 of the Disclosure Letter, (a) no Selling Party has (i) received any written notice from any Governmental Authority of any threatened or pending violation, investigation, audit or inquiry into an alleged or suspected violation of any applicable Law or of any of the Governmental Order that is or would reasonably be expected, individually or in the aggregate, to be material to the Business or the Purchased Assets, taken as a whole, or result in a material fine or assessment or a cease or desist order, or the suspension, revocation or limitation or restriction of any Permit that is material to the operation of the Business or the ownership of the Purchased Assets (a “Material Regulatory Event”), or (ii) entered into any agreement or settlement with any Governmental Authority with respect to its alleged non-compliance with, or violation of, any applicable Law; (b) the Sellers, and, to the Knowledge of the Selling Parties, all of their respective officers and directors and professionally licensed employees or contractors who provide professional services to or at any Facility or otherwise in connection with the Business (“Professional Personnel”) and any Referral Sources of the Business in their capacity as such, are in compliance in all material respects with, to the extent applicable, (i) all Laws, applicable to the Governmental Programs and (ii) all federal and state Laws and Guidance relating to health care fraud and abuse, including: (A) the Anti-Kickback Law, 42 U.S.C. § 1320a-7b, 42 C.F.R. § 1001.952, (B) the federal false coding statute, 42 U.S.C. § 1320a-7a, (C) the federal physician self-referral prohibition, 42 U.S.C. § 1395nn, 42 C.F.R. § 411.351 et seq., and (D) the false claims act, 31 U.S.C. § 3729 et seq., except to the extent that any non-compliance with the foregoing has not and would not reasonably be expected to result in a Material Regulatory Event; (c) no Selling Party, with respect to the Business or the Purchased Assets (i) is a party to any corporate integrity agreement or similar memorandum of understanding with any Governmental Authority, (ii) is subject to any order, judgment, injunction, award, decree or writ handed down, adopted or imposed by any Governmental Authority or (iii) since January 1, 2006, has adopted any board resolutions at the request of any Governmental Authority, in each case that restricts the conduct of its business or that impacts upon the management or operation of its business...
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Healthcare Regulatory. (a) During the five years prior to the date of this Agreement, no Company, nor any officer or employee of any Company, nor, to Company’s Knowledge, any agent of any Company has received notice that it is subject to any restriction or limitation on the receipt of payment under the Medicare program, Medicaid program, the TRICARE program, any other federally funded health care reimbursement program or any other third party payor under which the Business has received or is receiving reimbursement (collectively, the “Payment Programs”). Each Company has valid and current provider agreements with the Payment Programs. Each Company is, and at all times during the five years prior to the date of this Agreement, has been, in compliance in all material respects with the conditions of participation of the Payment Programs. During the five years prior to the date of this Agreement, and except as set forth on Schedule 3.22(a), (i) no Company, nor any officers or employees of any Company, nor, to Company’s Knowledge, any agents of any Company has received notice that a Payment Program has requested or threatened any recoupment, refund or set-off from such Company, or imposed any fine, penalty or other sanction on such Company, nor has any Company been excluded from participation in a Payment Program, (ii) there has not been any proceeding, or to Company’s Knowledge, any investigation or inquiry, by a Governmental Entity with respect to any Company’s participation in a Payment Program, and (iii) no Company has submitted to a Payment Program any false or fraudulent claim for payment, nor has any Company violated in any material respect any applicable condition for participation or any applicable published rule, regulation, policy or standard of a Payment Program. No validation review or program integrity review related to any Company has been conducted within the 12 months preceding the date of this Agreement by or on behalf of any Governmental Entity or Payment Program, and to the Company’s Knowledge, no such reviews are pending, scheduled or threatened. (b) During the five years prior to the date of this Agreement, (i) each Company has complied in all material respects with all applicable Health Care Laws and all Laws relating to the Payment Programs, and there is no pending, nor to Company’s Knowledge, threatened, proceeding or investigation by a Governmental Entity with respect to any Health Care Law or any Payment Programs involving any Company and (ii) no Company no...
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Healthcare Regulatory. (a) The Company and, to the Company’s knowledge, its directors, officers, employees and agents are and at all times have been in material compliance with all healthcare laws applicable to the business or by which any property, business product or other asset of the Company is bound or affected, including, but not limited to, the Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.), the Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the civil False Claims Act (31 U.S.C. § 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1230d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, the regulations promulgated pursuant to such laws, and any other law, accreditation standard, regulation, guidance document, manual provision, program memorandum, opinion letter, or other issuance by a Governmental Authority which regulates the Company’s business, each as amended from time to time (collectively, “Healthcare Laws”). To the Company’s knowledge, the Company has not received any notification or communication from any Governmental Authority, including, without limitation, the U.S. Food and Drug Administration (“FDA”), the Centers for Medicare and Medicaid Services, and the Department of Health and Human Services of material potential or actual noncompliance by, or liability of, the Company under any Healthcare Laws. (b) The Company is not party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders or similar agreements with or imposed by any Governmental Authority. (c) The Company has not been excluded from participation in any Federal or state health care program, as such terms are defined at 42 U.S.
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Healthcare Regulatory. (a) Solely with regard to any pharmacy or medical clinic of the Business for which Purchaser requests to transfer Seller’s NPI number and Medicare, Medicaid, or other state or federal health care program provider numbers pursuant to Section 5.06, each such pharmacy and medical clinic of the Business and, to the knowledge of Seller, the licensed professionals of Seller providing services for such pharmacy or medical clinic of the Business, meet all the requirements for participation in and payment under the Medicare, Medicaid and other state or federal health care programs in which that pharmacy or medical clinic of the Business participates (collectively “Programs”) and is a party to valid participation agreements for payment by such Programs if that pharmacy or medical clinic of the Business bills a particular Program for payment or is otherwise required to meet such requirements. Seller has not received any notice indicating that the enrollment or participation of any such pharmacy or medical clinic of the Business in a Program may be terminated or withdrawn nor, to Seller’s knowledge, is there any reason to believe that such enrollment or participation is likely to be terminated or
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Healthcare Regulatory. With respect to the Product, except as would not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities: (a) Each of the Seller Parties and its Subsidiaries is operating, and since [***] has been operating in compliance with applicable Health Care Program Laws with respect to its activities relating to the Product. (b) None of the Seller Parties and their Subsidiaries, nor, to the knowledge of the Seller Parties, any officer, director, managing employee or agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, is a party to, or bound by, any Regulatory Action with respect to the Product. (c) None of the Seller Parties and their Subsidiaries, nor, to the knowledge of the Seller Parties, any officer, director, managing employee or agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, nor any Seller Partner: (A) has been, since [***], convicted of any criminal offense relating to the delivery of an item or service under any Federal Healthcare Programs; (B) has had, Since [***], a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act; (C) has been listed on the U.S. General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; or (D) to the knowledge of the Seller Parties, is the target or subject of any current or potential suit, claim, action, proceeding, arbitration, mediation, inquiry, subpoena or investigation relating to any of the foregoing or any Federal Healthcare Program-related offense. Since [***], none of the Seller Parties and their Subsidiaries, nor, to the knowledge of the Seller Parties, any officer, director, managing employee or agent (as those terms are defined in 42 C.F.R. § 1001.1001) thereof, nor, to the knowledge of the Seller Parties, any Seller Partner, has been or is currently debarred, excluded, disqualified or suspended from participation in any Federal Healthcare Program or under any FDA Laws (including 21 U.S.C. § 335a). (d) [Reserved]. (e) Since [***], to the knowledge of the Seller Parties, no person has filed or has threatened to file against any Seller Party or any of its Subsidiaries, an action relating to any FDA Law, Public Health Law or Health Care Program Law under any whistleblower statute, including without limitation, the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.) with respect to such Seller Party’s or such Subsidiarie...
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Related to Healthcare Regulatory

  • Health Care Compliance Neither the Company nor any Affiliate has, prior to the Effective Time and in any material respect, violated any of the health care continuation requirements of COBRA, the requirements of FMLA, the requirements of the Health Insurance Portability and Accountability Act of 1996, the requirements of the Women's Health and Cancer Rights Act of 1998, the requirements of the Newborns' and Mothers' Health Protection Act of 1996, or any amendment to each such act, or any similar provisions of state law applicable to its Employees.

  • Healthcare Section 1. Bargaining unit employees with one (1) year or more of service will be provided coverage for the duration of this contract through the “Full Coverage” Team Care Plan (“Team Care MM200”), which includes dental, vision, life, short term disability, medical and prescription drug benefits. Prior to January 1, 2020, bargaining unit employees with less than one (1) year of service will be provided coverage through the “Medical Only” plan. On January 1, 2020, all bargaining unit employees enrolled in the Medical Only plan shall be enrolled in the Full Coverage plan, and the Medical Only plan will eliminated. The rates for 2019 and a further description of the plan and rates are referenced

  • COVERED HEALTHCARE SERVICES This section describes covered healthcare services. This plan covers services only if they meet all of the following requirements: • Listed as a covered healthcare service in this section. The fact that a provider has prescribed or recommended a service, or that it is the only available treatment for an illness or injury does not mean it is a covered healthcare service under this plan. • Medically necessary, consistent with our medical policies and related guidelines at the time the services are provided. • Not listed in Exclusions Section. • Received while a member is enrolled in the plan. • Consistent with applicable state or federal law. We review medical necessity in accordance with our medical policies and related guidelines. Our medical policies can be found on our website. Our medical policies are written to help administer benefits for the purpose of claims payment. They are made available to you for informational purposes and are subject to change. Medical policies are not meant to be used as a guide for your medical treatment. Your medical treatment remains a decision made by you with your physician. If you have questions about our medical policies, please call Customer Service. When a new service or drug becomes available, when possible, we will review it within six (6) months of one of the events described below to determine whether the new service or drug will be covered: • the assignment of an American Medical Association (AMA) Current Procedural Terminology (CPT) code in the annual CPT publication; • final Food and Drug Administration (FDA) approval; • the assignment of processing codes other than CPT codes or approval by governing or regulatory bodies other than the FDA; • submission to us of a claim meeting the criteria above; and • generally, the first date an FDA approved prescription drug is available in pharmacies (for prescription drug coverage only). During the review period, new services and drugs are not covered. For all covered healthcare services, please see the Summary of Medical Benefits and the Summary of Pharmacy Benefits to determine the amount that you pay and any benefit limits.

  • HEALTH CARE PLANS ‌ Notwithstanding the references to the Pacific Blue Cross Plans in this article, the parties agree that Employers, who are not currently providing benefits under the Pacific Blue Cross Plans may continue to provide the benefits through another carrier providing that the overall level of benefits is comparable to the level of benefits under the Pacific Blue Cross Plans.

  • Healthcare Matters Except where the failure to comply with any applicable Health Care Law could not reasonably be expected to have a Material Adverse Effect, Parent and each of its Subsidiaries is, and at all times since the Closing Date has been, in compliance with all Health Care Laws applicable to it, its assets, business or operations. No circumstance exists or event has occurred with respect to a violation of any Health Care Law that could reasonably be expected to have a Material Adverse Effect. Neither Parent nor any Subsidiary thereof has received any notice of communication from any Governmental Authority alleging noncompliance with any applicable Health Care Law that could reasonably be expected to have a Material Adverse Effect. For the avoidance of doubt, no notice or any information provided by any Governmental Authority pursuant to this Section 7.01(cc) shall need to be provided to the Administrative Agent or any of the Lenders if such action would be prohibited by Applicable Law. Notwithstanding any other provision of this Agreement or any other Transaction Document, the representations and warranties contained in this Section shall be continuing, and remain in full force and effect until the Final Payout Date.

  • Health Care Operations “Health Care Operations” shall have the same meaning as the term “health care operations” in 45 CFR §164.501.

  • Anti-Money Laundering/International Trade Law Compliance No Covered Entity is a Sanctioned Person. No Covered Entity, either in its own right or through any third party, (i) has any of its assets in a Sanctioned Country or in the possession, custody or control of a Sanctioned Person in violation of any Anti-Terrorism Law; (ii) does business in or with, or derives any of its income from investments in or transactions with, any Sanctioned Country or Sanctioned Person in violation of any Anti-Terrorism Law; or (iii) engages in any dealings or transactions prohibited by any Anti-Terrorism Law.

  • Compliance with Healthcare Laws The tests, studies, and trials conducted by or on behalf of or sponsored by the Company or any of its subsidiaries were and, if still pending, are being conducted in all material respects in accordance with all applicable Health Care Laws (as defined below) and standard medical and scientific research protocols, procedures, and controls; none of the Company or any of its subsidiaries has received any written notice, correspondence, or other written communication from any regulatory agency or any institutional review board or comparable body requiring or threatening the termination, suspension, or material modification of any tests, studies, or trials, or commercial distribution, and to the knowledge of the Company and its subsidiaries, there are no reasonable grounds for the same. Each of the Company and its Subsidiaries has obtained (or caused to be obtained) the informed consent of each human subject who participated in a test, study, or trial. None of the tests, studies, or trials involved any investigator who has been disqualified as a clinical investigator. The Company and its directors, officers, employees, and agents are, and at all times prior hereto have been, in material compliance with, all health care laws and regulations applicable to the Company or any of its product candidates or activities, including development and testing of pharmaceutical products, kickbacks, recordkeeping, documentation requirements, the hiring of employees (to the extent governed by Health Care Laws), quality, safety, privacy, security, licensure, accreditation or any other aspect of developing and testing health care or pharmaceutical products (collectively, “Health Care Laws”). The Company has not received any notification, correspondence or any other written or oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the United States Food and Drug Administration, the Drug Enforcement Agency, the Centers for Medicare & Medicaid Services, and the U.S. Department of Health and Human Services Office of Inspector General, of potential or actual non-compliance by, or liability of, the Company under any Health Care Laws. To the Company’s knowledge, there are no facts or circumstances that would reasonably be expected to give rise to liability of the Company under any Health Care Laws, except that would not individually or in the aggregate have a Material Adverse Effect.

  • Health Care Laws The Company and each of its subsidiaries is, and at all times has been, in compliance in all material respects with all applicable Health Care Laws, and has not engaged in activities which are, as applicable, 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: (i) the Federal Food, Drug, and Cosmetic Act, (ii) all applicable federal, state, local and 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. Physician Payment Sunshine Act (42 U.S.C. Section 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Claims Law (42 U.S.C. Section 1320a-7b(a)), all criminal Laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.) as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), (iii) Medicare (Title XVIII of the Social Security Act); (iv) Medicaid (Title XIX of the Social Security Act), (v) the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), (vi) Healthcare Product Laws, including but not limited to HIPAA, relating to data privacy and the protection of personal information, including personal health information, and (vii) any and all other applicable health care laws and regulations. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any court, arbitrator, other Governmental Authority or third party alleging that any product, operation or activity of the Company or a subsidiary is in material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action is threatened. Neither the Company nor any of its subsidiaries are a party to or have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency or other Governmental Authority. Neither the Company, any of its subsidiaries, any of their respective directors, officers, nor, to the Company’s knowledge, any of their respective employees or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to an inquiry, investigation, proceeding, or other similar action by any Governmental Authority that would reasonably be expected to result in debarment, suspension, or exclusion.

  • Extended Health Care Plan ‌ The Employer shall pay the monthly premium for regular employees entitled to coverage under a mutually acceptable extended health care plan.

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