Health Regulatory Matters. The Company and its Subsidiaries have complied in all material respects with all statutes and regulations related to the research, manufacture and sale of medical device products to the extent applicable to the Company’s and its Subsidiaries’ activities. Items manufactured or under investigation by the Company and its Subsidiaries comply with all applicable manufacturing practices regulations and other requirements established by government regulators in the jurisdictions in which the Company or its Subsidiaries manufacture their products. To the Company’s knowledge, it is not and its Subsidiaries are not the subject of any investigation by any competent authority with respect to the development, testing, manufacturing and distribution of their products, nor has any investigation, prosecution, or other enforcement action been threatened by any regulatory agency. Neither the Company nor any of its Subsidiaries has received from any regulatory agency any letter or other document asserting that the Company or any Subsidiary has violated any statute or regulation enforced by that agency with respect to the development, testing, manufacturing and distribution of their products. To the Company’s knowledge, research conducted by or for the Company and its Subsidiaries has complied in all material respects with all applicable legal requirements. To the Company’s knowledge, research involving human subjects conducted by or for the Company and its Subsidiaries has been conducted in compliance in all respects with all applicable statutes and regulations governing the protection of human subjects and not involved any investigator who has been disqualified as a clinical investigator by any regulatory agency or has been found by any agency with jurisdiction to have engaged in scientific misconduct.
Health Regulatory Matters. Except as would not reasonably be expected to have a Material Adverse Effect, comply with and maintain all applicable Registrations and comply with all applicable Drug Regulatory Laws, Healthcare Regulatory Laws, and Government Pricing Program Obligations.
Health Regulatory Matters. Except as has not had, or would reasonably be expected to have, a Lafite Material Adverse Effect:
Health Regulatory Matters. Except as has not had, or would reasonably be expected to have, a Tempranillo Material Adverse Effect:
Health Regulatory Matters. (a) The Acquired Companies have filed with the applicable regulatory authorities (including the FDA or any other Governmental Authority performing functions similar to those performed by the FDA) for all Company Regulatory Permits and have made all required material filings, declarations, listings, registrations, reports or submissions, including but not limited to adverse event reports, except as would not have, and would not reasonably be expected to have a Company Material Adverse Effect. All such Company Regulatory Permits, filings, declarations, listings, registrations, reports or submissions were in material compliance with Applicable Law when filed, and, as of the date of this Agreement, no deficiencies have been asserted in writing by any applicable Governmental Authority to the Company with respect to any such Company Regulatory Permits, filings, declarations, listing, registrations, reports or submissions, except as would not have, and would not reasonably be expected to have, a Company Material Adverse Effect.
Health Regulatory Matters. (a) The Company has filed with the applicable regulatory authorities (including the FDA, the European Medicines Agency (“EMA”), or any other Governmental Authority performing functions similar to those performed by the FDA) (each a “Company Regulatory Agency”) for all Company Regulatory Permits and has made all required filings, declarations, listings, registrations, reports or submissions, including but not limited to adverse event reports. All such Company Regulatory Permits, filings, declarations, listings, registrations, reports or submissions were in material compliance with Applicable Law when filed, and, as of the date of this Agreement, no deficiencies have been asserted in writing by any applicable Governmental Authority to the Company with respect to any such Company Regulatory Permits, filings, declarations, listing, registrations, reports or submissions.
Health Regulatory Matters. (a) Except as has not been, or would not reasonably be expected to be, material to the Acquired Companies, taken as a whole, since January 1, 2017, (i) the Acquired Companies have timely filed with the applicable Company Regulatory Authority (including the FDA and the European Medicines Agency) for all Company Regulatory Permits and (ii) the Acquired Companies and, to the Company’s Knowledge, all Third Parties, as applicable, have timely made all required material filings, declarations, listings, registrations, reports, submissions, applications, amendments, modifications, supplements, notices and other documents with respect to the Product and the Company Regulatory Permits, including adverse event reports, or otherwise required by Health Care Laws (as defined below) with the applicable Governmental Authorities (collectively, the “Health Care Submissions”).
Health Regulatory Matters. Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect:
Health Regulatory Matters. Except as set forth on Section 3.25 of the Seller’s Disclosure Schedule, each Acquired Company and, to the extent related directly to APNY’s Traditional Insurance Policies, APNY is in compliance in all material respects with all applicable Health Care Laws, and the rules, policies and requirements of each federal or state health insurance program that govern or pertain to the Traditional Insurance Business other than the major medical health insurance policies that the Acquired Companies or APNY have issued, and with respect to the major medical health insurance policies that the Acquired Companies or APNY have issued, each Acquired Company and APNY, as applicable, is in compliance in with all applicable Health Care Laws, and the rules, policies and requirements of each federal or state health insurance program that govern or pertain to such major medical health insurance policies except for failures so to comply that do not have or would not, in the aggregate, reasonably be expected to have, a Company Material Adverse Effect. Without limiting the generality of the foregoing, none of the Acquired Companies or, to the extent related directly to APNY’s Traditional Insurance Policies, APNY, or any stockholder, member, director, manager, officer, or employee of any Acquired Company or APNY: (i) has been assessed a civil monetary penalty under Section 1128A of the Social Security Act or any regulations promulgated thereunder; (ii) has been debarred, excluded, suspended from participating, or declared ineligible to participate in any federal or state health care program (as such terms are defined as defined in 42 U.S.C. § 1320a-7b(f)) or from receiving a contract or subcontract paid in whole or in part by federal or state funds; (iii) is or has been a party to a corporate integrity agreement, corporate compliance agreement or other settlement agreement, applicable or pertaining in whole or in part to the Traditional Insurance Business, with any Governmental Authority, including the Office of the Inspector General of the United States Department of Health and Human Services, the Centers for Medicare & Medicaid Services, the United States Department of Justice, any Medicaid Fraud Control Unit, any state Attorney General, or any state insurance department or commission, as a result of an alleged violation of any Health Care Law; (iv) has been convicted of any criminal offense under any Health Care Law; (v) is or has been a party to or subject to any Legal Action, o...
Health Regulatory Matters. (a) The Company has complied in all material respects with the U.S. Federal Food, Drug, and Cosmetic Act, the regulations issued thereunder, and similar state and foreign statutes and regulations to the extent applicable to the Company’s activities. Items manufactured or under investigation by the Company comply with all applicable good manufacturing practices regulations and other requirements established by the FDA. To the Company’s knowledge, it is not the subject of any investigation by the FDA or any similar state or foreign agency, nor has any investigation, prosecution, or other enforcement action been threatened by the FDA or any similar state or foreign agency. The Company has not received from the FDA or any similar federal, state, or foreign agency any letter or other document asserting that the Company has violated any statute or regulation enforced by that agency.
