Healthcare Regulatory Sample Clauses

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...

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.

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

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...

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 “▇▇▇▇▇ 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...

Healthcare Regulatory. (a) The Company and its Subsidiaries and, to the Company’s Knowledge, their 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 and its Subsidiaries are bound or affected, including 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) Neither the Company nor any of its Subsidiaries is party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders or similar agreements with or imposed by any Governmental Authority. (c) Neither the Company nor any of its Subsidiaries participates in any Federal or state health care program, as such terms are defined at 42 U.S.C. Section 1320a-7b(f) (collectively, the “Programs”), and there is no audit, claim review, or other action pending or, to the Company’s Knowledge, threatened which could result in the imposition of penalties or the exclusion of the Company from any Program and the Company has not received notice of any such audit, claim review or other action. (d) Neither the Company nor any of its Subsidiaries, or to the Company’s Knowledge, their respective managers, officers, employees and agents have been convicted of any crime or engaged in any conduct that could result ...

Healthcare Regulatory. (a) Except as would not, individually or in the aggregate, reasonably be expected to be material to the Company and its subsidiaries, the Company and its subsidiaries and, to the knowledge of the Company and to the extent related to any product candidate of the Company, their Collaboration Partners, are, and since the Applicable Date, have been, in material compliance with all Healthcare Laws. Neither the Company nor its subsidiaries, nor any of their respective officers or directors: (i) is a party to any individual or corporate integrity agreements, monitoring agreements, deferred prosecution agreements, consent decrees, settlement orders, or similar agreements imposed by any Governmental Entity relating to any noncompliance with Healthcare Laws; (ii) has been assessed a civil money penalty under Section 1128A of the Social Security Act or any regulations promulgated thereunder or any other fine or penalty by any other Governmental Entity; or (iii) has been charged with, convicted of or entered a plea of guilty or nolo contendere to any criminal or civil offense relating to the delivery of any item or service under a Governmental Health Program. Neither the Company nor any of its subsidiaries nor, to the knowledge of the Company and to the extent related to any product candidate of the Company, any of any of their Collaboration Partners, is or, since the Applicable Date, has been, subject to any ongoing enforcement, regulatory or administrative proceedings against such Company or subsidiary alleging material non-compliance with any Healthcare Laws. Neither the Company nor any of its subsidiaries nor, to the knowledge of the Company and to the extent related to any product candidate of the Company, any of any of their Collaboration Partners has received any notification or communication from any Governmental Entity alleging any material non-compliance with any Healthcare Law, including any FDA Form 483, warning letter, or similar notice from any Governmental Entity. (b) The Company and its subsidiaries and, to the knowledge of the Company and to the extent related to any product candidate of the Company, their Collaboration Partners hold all material Regulatory Permits required for their business as currently conducted, and each such Regulatory Permit is valid and in full force and effect. The Company and its subsidiaries and, to the knowledge of the Company and to the extent related to any product candidate of the Company, their Collaboration Partners ar...

Healthcare Regulatory. The Companies are, and for the prior three (3) years have been, in compliance, in all material respects with all applicable Healthcare Laws. At no time during the prior three (3) years, have the Companies received any notice or communication from any Governmental Authority alleging any material violation or noncompliance or material liability of, the Companies under any Healthcare Law. (i) Neither the Companies, nor any equity owner, director, officer, manager, managing employee (as such term is defined in 42 U.S.C. § 1320a-5(b)), vendor, agent or other personnel (whether employees or independent contractors) of the Companies is currently or has been, or to the Companies’ knowledge, is threatened to be: (i) debarred, excluded or suspended from participating in any governmental health program or otherwise excluded under any Healthcare Law (ii) subject to a civil monetary penalty assessed under Section 1128A of the Social Security Act, sanctioned, indicted or convicted of a crime, or pled nolo contendere or to sufficient facts, in connection with any allegation of violation of any governmental health program requirement or Law, (iii) listed on the General Services Administration’s published list of parties excluded from federal procurement programs and non-procurement programs or (iv) subject to any other debarment, exclusion or sanction list or database. (ii) The Companies are not and have never been subject to HIPAA as a “business associate” or “covered entity,” as defined in regulations promulgated thereunder, nor have the Companies, or any other person acting on its behalf ever used, disclosed, created, received, maintained, accessed, or transmitted “protected health information” (as defined under HIPAA).

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