facilitate any activities of or business in any Sanctioned Country or (iii) in any other manner that will result in a violation by any person (including any person participating in the
transaction, whether as underwriter, advisor, investor or otherwise) of Sanctions. The Company has not knowingly engaged in and are not now knowingly engaged in any dealings or transactions with any person that at the time of the dealing or
transaction is or was the subject or the target of Sanctions or with any Sanctioned Country.
(ii) Compliance with Anti-Money
Laundering Laws. The operations of the Company is and has been conducted at all times in compliance with applicable financial recordkeeping and reporting requirements, including those of the Bank Secrecy Act, as amended by Title III of the
Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001 (USA PATRIOT Act), and the applicable money laundering statutes of all jurisdictions where the Company conducts business, the
rules and regulations thereunder and any related or similar rules, regulations or guidelines issued, administered or enforced by any governmental or regulatory agency (collectively, the Anti-Money Laundering Laws) and no action,
suit or proceeding by or before any court or governmental or regulatory agency, authority or body or any arbitrator involving the Company with respect to the Anti-Money Laundering Laws is pending or, to the Companys Knowledge, threatened.
(jj) Compliance with Health Care Laws. Except as disclosed in the SEC Reports, and except as would not, individually or in the
aggregate, reasonably be expected to have a Material Adverse Effect, the Company and, to the Companys Knowledge, its directors, officers, employees, independent contractors, agents and affiliates are, and at all times have been, in compliance
with all applicable Health Care Laws. For purposes of this Agreement, Health Care Laws means: (i) the FDCA, the Public Health Service Act (42 U.S.C. § 201 et seq.) and the regulations promulgated thereunder;
(ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil
False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Law (42 U.S.C. Section 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not
limited to 18 U.S.C. Sections 286, 287 and 1349, the health care fraud criminal provisions under HIPAA, the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C Section 1320-7h), and the laws governing U.S. government funded or sponsored healthcare programs; and
(iii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company, and (iv) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or
governmental or regulatory authority or third party alleging that any product, operation or activity is in violation of any Health Care Laws nor, to the Companys Knowledge, is any such claim, action, suit, proceeding, hearing, enforcement,
investigation, arbitration or other action threatened, except where any of the foregoing, if resolved adversely to the Company, would not reasonably be expected to have a Material Adverse Effect. Except as would not, whether individually or in the
aggregate, reasonably be expected to have a Material Adverse Effect, the Company has filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required
by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent
submission). The Company is not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority or body. Additionally, none
of the Company, its employees, officers, directors, or, to the Companys Knowledge, independent contractors, affiliates or agents, has been excluded, suspended or debarred from participation in any U.S. federal health care program or human
clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension or exclusion.
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