(hh) OFAC. Neither the Company nor any of its Subsidiaries nor, to the Companys
Knowledge, after due inquiry, any director, officer, agent, employee, Affiliates or person acting on behalf of the Company or any of its Subsidiaries is currently subject to any U.S. sanctions administered by the Office of Foreign Assets Control of
the U.S. Treasury Department (OFAC) or other relevant sanctions authority (Sanctions); and the Company will not directly or indirectly use the proceeds of this offering, or lend, contribute or otherwise make
available such proceeds to any Subsidiary, or any joint venture partner or other person or entity, for the purpose of financing the activities of or business with any person, or in any country or territory, that currently is the subject of Sanctions
or 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 applicable Sanctions.
(ii) Compliance with Healthcare Laws. Except as described in the Registration Statement or the Prospectus Supplement, and except as
would not, individually or in the aggregate, have or may reasonably be expected to have a Material Adverse Effect: (i) the Companys and each of its Subsidiaries business practices have been designed to comply with state, federal and
foreign laws applicable to the Companys and its Subsidiaries respective businesses, and the Company and its Subsidiaries are in compliance with such laws including, without limitation, applicable provisions of: (A) the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) and the Public Health Service Act (42 U.S.C. § 201 et seq.), and the regulations promulgated thereunder; (B) all applicable federal, state, local and foreign health care related fraud
and abuse laws, including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the federal civil False Claims Act (31 U.S.C. §3729 et seq.), the federal criminal false
claims law (42 U.S.C. § 1320a-7b(a)), the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (HIPAA) (42 U.S.C. §1320d
et seq.), the Federal Health Care Program Exclusion Laws (42 U.S.C. §1320a-7); and (C) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C.
§17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or
prescribers (collectively, Health Care Laws); (ii) the Company and its Subsidiaries have not engaged in activities which are cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid,
or any other state health care program or federal health care program; (iii) neither the Company nor its Subsidiaries have 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, has any, such claim, action,
suit, proceeding, hearing, enforcement, investigation, arbitration or other action been threatened; (iv) the Company and its Subsidiaries have 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 in all material respects (or were corrected or supplemented by a subsequent submission); (v) neither the Company nor its Subsidiaries are a party to any corporate integrity agreements, monitoring agreements, consent decrees, plans of
correction, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority; and (vi) neither the Company, its Subsidiaries nor any of their respective officers, directors, employees, or agents have been
excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the Companys Knowledge, is currently subject to a governmental inquiry, investigation, proceeding, or other similar
action that could reasonably be expected to result in debarment, suspension, or exclusion.
16