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 No Seller has received any notice indicating that such qualification may be terminated or withdrawn nor has any reason to believe that such qualification may be terminated or withdrawn.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. Except as set forth in Section 2.17 of the Disclosure Letter,
Healthcare Regulatory. Except as would not reasonably be expected to be material to the Company and its Subsidiaries, taken as a whole:
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.
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.
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.
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.
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
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:
