(f) During the past three (3) years, the Group Companies have not distributed any Company Products that were upon their shipment by any Group Company adulterated or misbranded in violation of 21 U.S.C. § 331 or any other Governmental Entity’s jurisdiction. No Company Products have been seized, withdrawn, recalled, detained or subject to a suspension (other than in the ordinary course of business) of research, development, testing, manufacturing or distribution, and, to the knowledge of the Company, there are no facts or circumstances reasonably likely to cause (i) the seizure, withdrawal, recall, or detention, or public health notification or safety alert relating to any Company Product or (ii) a termination or suspension of research, development, testing, clinical investigation, manufacturing or distributing of any Company Product, in either case, except as would not have a Company Material Adverse Effect. There are no Proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, revocation, suspension, import detention or seizure of any Company Product pending or, to the Company’s knowledge, threatened against the Group Companies, except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Group Companies, taken as a whole.
(g) None of the Group Companies nor any of their respective directors, managers, officers, employees, or, to the Company’s knowledge, any of their respective individual independent contractors or other service providers, including clinical trial investigators, coordinators, monitors have been within the past three (3) years or are currently disqualified, excluded or debarred from, or threatened with or currently subject to an investigation or proceeding that could result in disqualification, exclusion or debarment under state or federal statutes or regulations, or assessed or threatened with assessment of civil monetary penalties regarding any health care programs of any Governmental Entity, or convicted of any crime regarding health care products or services, or engaged in any conduct that would reasonably be expected to result in any such debarment, exclusion, disqualification, or ineligibility, including, without limitation, (A) debarment under 21 U.S.C. Section 335a or any similar Law; (B) exclusion under 42 U.S.C. Section 1320a-7 or any similar Law; (C) exclusion under 48 CFR Subpart Section 9.4, the System for Award Management Nonprocurement Common Rule or (D) disqualification under 21 CFR Section 812.119. None of the Group Companies nor, to the knowledge of the Company, any of their current or former members, officers, partners, employees, contractors or agents, is or has been subject to any consent decree of, or criminal or civil fine or penalty imposed by, any Governmental Entity related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, or obstruction of an investigation of controlled substances. None of the Group Companies nor to the knowledge of the Company any of their current or former members, officers, partners, employees, contractors or agents has been within the past three (3) years (i) subject to any enforcement, regulatory or administrative proceedings against or affecting the Company or any of its Affiliates relating to or arising under any Healthcare Law and no such enforcement, regulatory or administrative proceeding has been threatened in writing, or (ii) a party to any corporate integrity agreement, monitoring agreement, deferred prosecution agreement, nonprosecution agreement, consent decree, settlement order, or similar agreement imposed by any Governmental Entity. None of the Group Companies nor to the knowledge of the Company any of their officers, directors, employees, agents or contractors have received notice from the FDA, any other Governmental Entity and/or any health insurance institution with respect to debarment, disqualification or restriction, and there is no act, omission, event, or circumstance of which Company is aware that would reasonably be expected to give rise to or lead to any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, proceeding or request for information pending against any Group Company.
(h) All material reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Governmental Entity by the Company involving Company Products have been so filed, maintained or furnished. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected or supplemented by a subsequent filing), and any material updates, changes, corrections or modification to such reports, documents, claims, permits and notices required under applicable Healthcare Laws have been submitted.
(i) Except would not reasonably be expected to have a material adverse effect individually or in the aggregate, the Group Companies and, to the Company’s knowledge, their Representatives, and any other Persons acting for or on behalf of any of the foregoing, are and have been for the past three (3) years, in compliance with all Healthcare Laws. None of the Group Companies, any of their respective officers, directors, employees or agents, has directly or indirectly offered to pay any remuneration to or solicited any remuneration from, in cash, property or in kind, or made any financial arrangements with, any past or present customer, physician, health care provider, supplier, contractor, third party, or health care program in order to induce or directly or indirectly obtain business or payments for any item or service or for purchasing, leasing, ordering or arranging for or recommending, purchasing, leasing, or ordering any good, service or item. Within the past three (3) years, none of the Group Companies, nor any of their respective officers, directors, employees or agents, has submitted or caused to be submitted any claim for payment to any health care program in violation of any applicable Healthcare Laws.
(j) To the Company’s knowledge, within the past three (3) years, no officer nor any other employee or agent of any Group Company has (x) made any untrue statement of material fact or fraudulent statement to the FDA or any other Governmental