Compliance with Laws; Regulatory Matters. (a) Other than for non-compliance or violations which would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, the Company and each of its Subsidiaries are and, at all times since January 1, 2014, have been, in compliance with all applicable Laws. To the knowledge of the Company, no material investigation or review by any Governmental Authority with respect to the Company or any of its Subsidiaries is pending or is being threatened. To the knowledge of the Company, since January 1, 2014, neither the Company nor any of its Subsidiaries has received any written or oral notice or communication that the Company or any of its Subsidiaries are in violation of any applicable Law, except for such violations that would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(i) The Company and each of its Subsidiaries hold all authorizations, licenses, permits, certificates, filings, consents, variances, exemptions, waivers, approvals, Orders, registrations and clearances of any Governmental Authority (the “Company Permits”), necessary for the Company and each Subsidiary to own, lease and operate its properties and assets, and to carry on and operate its businesses as currently conducted, (ii) the Company and each of its Subsidiaries are, and at all times since January 1, 2014 have been, in compliance with the terms of the Company Permits in all respects, and all of the Company Permits are valid and in full force and effect, and (iii) as of the date of this Agreement, neither the Company nor any of its Subsidiaries has received any written notice of any violation or failure to comply with any Company Permit and no suspension, modification, revocation or cancellation of any of the Company Permits is, to the knowledge of the Company, pending or threatened, except, in the case of each of clauses (i), (ii) and (iii), as would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(c) Except as would not be material, since January 1, 2014, to the knowledge of the Company, (i) neither the Company nor any of its Subsidiaries has, nor have any of their Representatives, violated any Anti-Corruption Laws and (ii) neither the Company nor any of its Subsidiaries has, nor have any of their Representatives, offered, paid, promised to pay, or authorized the payment of any money, or offered, given, promised...
Compliance with Laws; Regulatory Matters. (a) Each Buyer Party is, and since the Regulatory Lookback Date has been, in compliance with all applicable Laws, including Laws relating to money transmission, virtual currency or other digital assets, consumer protection, credit reporting, data privacy, financial privacy, cybersecurity, securities Law matters, and payment services Law matters (including payment network rules) and Governmental Orders directly applicable to it, except where failure to so comply would not, individually or in the aggregate, reasonably be expected to have a Buyer Material Adverse Effect. Since the Regulatory Lookback Date, no Buyer Party has received any written notice or other written communication from any Governmental Authority or any written notice from any other Person (i) regarding any actual or possible violation of, or failure to comply with, any Law or (ii) that it is or has been the subject of any inspection, investigation, survey, audit, monitoring or other form of review by any Governmental Authority, except as would not, individually or in the aggregate, reasonably be expected to have a Buyer Material Adverse Effect.
(b) Since the Regulatory Lookback Date, no Buyer Party or any other member of the Buyer Licensing Group, has been in violation of Money Services Laws, or, to the extent applicable, been denied a Money Services Permit or other Permit by any Governmental Authority or had any Money Services Permit or other Permit revoked or suspended.
(c) Each Buyer Party is, and at all times since the Regulatory Lookback Date has been, in compliance with all applicable Anti-Money Laundering Laws. None of the Buyer Parties or any other member of the Buyer Licensing Group, nor any of their respective directors, officers, employees or, to the knowledge of Buyer, agents designated by any Buyer Party or any other member of the Buyer Licensing Group to act on behalf of any Buyer Party or any other member of the Buyer Licensing Group, is in violation of any applicable Anti-Money Laundering Laws.
Compliance with Laws; Regulatory Matters. Reliant has materially complied with all applicable Laws relating to the Product, the Product Line Operations and the Acquired Assets. The Registrations and all such other permits, government licenses, registrations, approvals, concessions, franchises and authorizations required for the manufacturing, marketing, sale and distribution of the Product in the Territory are in full force and effect. Without limiting the generality of the foregoing sentence, Reliant represents and warrants that, except as set forth in Schedule 5.9 of the Reliant Disclosure Schedule:
(a) neither Reliant nor to Reliant’s Knowledge Ethypharm has (i) received a warning letter or Form FDA 483 from any Governmental Authority with jurisdiction over the Product; (ii) any notice of any Governmental Authority detention, seizure, injunction, consent decree, notice of criminal investigation, indictment, sentencing memorandum, plea agreement, court order, target or no-target letter, or other investigation relating to the Product; or (iii) initiated or been required to effect any product recall, market withdrawal, stock replacement, or post-sale warning relating to the Product;
(b) to Reliant’s Knowledge, the Product has been manufactured, processed, packaged, labeled, stored and shipped in material compliance with applicable Law, including the current good manufacturing practice requirements of 21 U.S.C. § 351(a) and 21 C.F.R. Parts 210 and 211;
(c) to Reliant’s Knowledge, Reliant has advertised, marketed, and promoted Product in material compliance with applicable Law, including the Act, the PDM Act, the False Claims Act (31 U.S.C. §§ 3729-3733), the Social Security Act Anti-Kickback Prohibitions (42 U.S.C. § 1320a-7b), and state law equivalents of the foregoing; and
(d) Reliant has furnished Oscient with access to a complete and accurate copy of the Product NDA and all material related FDA correspondence, including all amendments and supplements thereto.
Compliance with Laws; Regulatory Matters. The Company is in compliance in all material respects with all laws, rules and regulations, all orders, directives and supervisory letters of, and all agreements, memoranda of understanding or similar arrangements with, regulatory authorities and all other legal requirements applicable to the Company or the Company's businesses; and the Company is not subject to any order, directive or supervisory letter of, or agreement, memorandum or understanding or similar arrangement (including board resolutions adopted at the request of regulatory authority) with, any regulatory authority restricting its operations or, restricting it from taking any action or requiring that certain actions be taken, and the Company has no knowledge that any such order, directive, supervisory letter, agreement, memorandum or understanding or similar arrangement is threatened, contemplated or under consideration by any regulatory authority.
Compliance with Laws; Regulatory Matters. (a) Except as set forth in Section 5.13(a) of the Seller Disclosure Schedule, the Business is being, and at all times within the past five years has been, conducted in compliance in all material respects with all applicable Laws including but not limited to (A) the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. Sections 301 et seq.) (the “FDCA”) and the regulations promulgated thereunder, (B) the Public Health Service Act (42 U.S.C. Sections 201 et seq.) and the regulations promulgated thereunder; (C) the Veterans Health Care Act (38 U.S.C. Section 126) and the regulations promulgated thereunder; (D) federal Medicare (Title XVIII of the Social Security Act) and Medicaid (Title XIX of the Social Security Act) statutes and the regulations promulgated thereunder, and any related Laws; (E) Laws relating to healthcare fraud and abuse, false claims and anti-kickback laws, including the Federal Anti-Kickback Statute (42 U.S.C. Sections 1320a-7b(b))), the Federal False Claims Act (31 U.S.C. Section 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the criminal laws (18 U.S.C. §§ 286 and 287), the exclusion laws (42 U.S.C, § 1320a-7), or any similar Laws; (F) Laws regarding the reporting of prices and promotional expenditures to healthcare professionals including the federal Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h) and similar state gift and disclosure Laws; (G) the Health Insurance Portability and Accountability Act of 1996 as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, the regulations promulgated thereunder and similar Laws pertaining to privacy, data protection and information security; (H) state Laws relating to the manufacture, sale, and distribution of medical products; and (I) all applicable Laws of other comparable foreign Governmental Bodies (collectively, “Health Care Laws”).
(b) Neither Seller nor its Affiliates is debarred under 21 U.S.C. Section 335a or any similar Law, or is otherwise excluded from or restricted in any manner from participation in any government program related to medical devices in the United States or any other country in which Seller conducts business and, to Seller’s Knowledge, no Person affiliated with Seller employs or uses the services of any person who is so debarred or otherwise excluded or restricted. As of the date h...
Compliance with Laws; Regulatory Matters. Intellectual Property; (D) Environmental Matters; (E) Contracts; (F) Benefit Arrangements; Labor Matters; and (G) Customers and Suppliers. (c) When delivered pursuant to Section 5.11, the Audited Financial Statements and the Interim Financial Statements will have been prepared in accordance with GAAP and Regulation S-X promulgated pursuant to the Exchange Act, consistently applied based on the historic practices and accounting policies of Remainco (to the extent compliant with GAAP), as at the dates and for the periods presented (except as noted therein), and fairly present in all material respects the financial position, results of operations and cash flows of the Spinco Business as of the dates and for the periods presented on the basis for the periods presented (subject to year-end adjustments, in the case of the Interim Financial Statements) (it being understood that the Spinco Business has not been operated historically as a separate “standalone” entity, and therefore the Audited Financial Statements and the Interim Financial Statements will reflect certain allocations made that may not reflect what would have been incurred if the Spinco Business had been a standalone business). The Audited Financial Statements and the Interim Financial Statements shall conform in all material respects to the published rules and regulations of the SEC applicable to financial statements for each of the periods that will be required to be included in the Merger Partner Registration Statement and the Spinco Registration Statement. (d) Remainco has delivered or Made Available to Merger Partner accurate and complete copies of all Remainco SEC Documents. All statements, reports, schedules, forms and other documents required to have been filed by Remainco or its officers with the SEC since the Lookback Date have been so filed on a timely basis. None of the members of the Spinco Group is required to file any documents with the SEC. As of the time it was filed with the SEC (or, if amended or superseded by a filing prior to the date hereof, then on the date of such filing) (i) each of the Remainco SEC Documents complied as to form in all material respects with the applicable requirements of the Securities Act or the Exchange Act (as the case may be) and (ii) none of the Remainco SEC Documents contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary to make the statements therein, in the light of the circums...
Compliance with Laws; Regulatory Matters. 4.6.1. The Company is not in breach or violation of, or default under, its Constitutive Documents. The Company is, and since its formation has been, in material compliance with all Applicable Laws and Judgments of any Governmental Authority applicable to it or to the conduct by the Company of its business, or the ownership or use of any of its assets and properties, including the Leased Properties. The Company has not received, since its formation, a written or, to its knowledge, oral notice or other communication alleging a material violation by the Company of any Applicable Law of any Governmental Authority applicable to its businesses or operations. No event has occurred nor does any circumstance exist that would reasonably be expected to give rise to an obligation on the part of the Company to undertake, or to bear all or any portion of the cost of, any material remedial action of any nature.
4.6.2. The Products are currently and at all times have been researched, developed, tested, labeled, manufactured, stored, imported, exported, promoted, marketed, sold and distributed, as applicable, by the Company, and to the knowledge of the Company, on behalf of the Company and by or on behalf of any Representative of the Company, in compliance in all material respects with all Applicable Laws, including the FD&C Act; the Public Health Service Act (“PHSA”); Applicable Laws governing interactions with healthcare professionals; analogous laws promulgated by foreign, federal, state, provincial or local Governmental Authorities; and any regulations adopted by Regulatory Authorities thereunder (including, as applicable, those requirements relating to cGMP, GLP, GCP, investigational use, and pre-market approval).
4.6.3. The Company, and to the knowledge of the Company, each Institution, has generated, prepared, maintained and retained all material information, data and biological materials that are required to be generated, prepared, maintained or retained by the Company and each Institution, as applicable, with respect to Products pursuant to, and materially in accordance with, GCP, GLP, cGMP and other Applicable Laws in the U.S. and, with respect to any activities conducted outside the U.S., the Applicable Laws in such jurisdiction. As of the date hereof, the Company has not received written notice of and, to the knowledge of the Company, as of the date hereof the Company has not received any other notice of, any pending or threatened Action from the FDA or any oth...
Compliance with Laws; Regulatory Matters. (a) Each member of the Merger Partner Group is, and since the Regulatory Lookback Date has been, in compliance with all applicable Laws, including Laws relating to money transmission, virtual currency or other digital assets, consumer protection, credit reporting, data privacy, financial privacy, cybersecurity, securities Law matters, and payment services Law matters (including payment network rules) and Governmental Orders directly applicable to it, except where failure to so comply would not, individually or in the aggregate, reasonably be expected to be material to the Merger Partner Business or the Merger Partner Group, taken as a whole. Since the Regulatory Lookback Date, none of the members of the Merger Partner Group has received any written notice or other written communication from any Governmental Authority or any written notice from any other Person (a) regarding any actual or possible violation of, or failure to comply with, any Law or (b) that it is or has been the subject of any inspection, investigation, survey, audit, monitoring or other form of review by any Governmental Authority, except as would not, individually or in the aggregate, reasonably be expected to be material to the Merger Partner Business or the Merger Partner Group, taken as a whole. (b) Since the Regulatory Lookback Date, none of the members of the Merger Partner Group have been in violations of Money Services Laws, or, to the extent applicable, been denied a Money Services Permit or other Permit by any Governmental Authority or had any Money Services Permit or other Permit revoked or suspended.
Compliance with Laws; Regulatory Matters. (a) Except for instances of noncompliance that have not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, the Company and each of its Subsidiaries is, and at all times during the last five (5) years has been, in compliance with all Laws and Orders applicable to the Company and its Subsidiaries, provided, however, that no representation or warranty is being made in this Section 4.20(a) with respect to (i) compliance with the Securities Act and the Exchange Act, (ii) intellectual property and related matters, which are covered solely in Section 4.15, (iii) applicable Laws with respect to Taxes, which are covered solely in Section 4.16, (iv) ERISA and other employee benefit-related matters, which are covered solely in Section 4.17, (v) labor Law matters, which are covered solely in Section 4.18, or (vi) Environmental Laws, which are covered solely in Section 4.21.
(b) The Company and each of its Subsidiaries is, and at all times during the last five (5) years has been, in material compliance with the Foreign Corrupt Practices Act of 1977, as amended, and any rules or regulations thereunder, and any comparable foreign Law or statute.
(c) Neither the Company nor any of its Subsidiaries is party to any corporate integrity agreements, monitoring agreements, deferred prosecution agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Authority and, to the Company’s Knowledge, no such action is currently contemplated, proposed or pending.
Compliance with Laws; Regulatory Matters. (i) Each of the IESI-BFC Entities is in compliance with and has conducted its business in compliance with all applicable Laws, including without limitation, the Foreign Corrupt Practices Act and any applicable foreign corrupt practice Law, and Orders, except for instances of non-compliance which, individually or in the aggregate, have not had and would not reasonably be expected to have a Material Adverse Effect, and (ii) none of the IESI-BFC Entities has received any written communication during the past three years from a Governmental Authority that alleges that any of the IESI-BFC Entities is not in compliance in any material respect with any applicable Law or Order. None of the IESI-BFC Entities have received notice that any investigation or review of the IESI-BFC Entities or the IESI-BFC Business by any Governmental Authority is pending. This Section 4.16 does not relate to matters with respect to Taxes, or Environmental Requirements, which are subject of Sections 4.13 and 4.17, respectively.
