organization, or any political party, party official or candidate for political office; (C) violated or is in violation of any applicable provision of the U.S. Foreign Corrupt Practices Act
of 1977 (the FCPA), the UK Bribery Act 2010, or any other applicable anti-bribery or anti-corruption law; or (D) made, offered, authorized, requested, or taken an act in furtherance of any unlawful bribe, rebate, payoff,
influence payment, kickback or other unlawful payment or benefit. The Company and its Subsidiaries have conducted their respective businesses in compliance with the FCPA and have instituted and maintain policies and procedures designed to ensure
compliance therewith.
(rr) No Conflicts. None of the execution of this Agreement, the issuance, offering or sale of the Offered
Shares, the consummation of any of the transactions contemplated hereby and thereby, or the compliance by the Company with the terms and provisions hereof and thereof will conflict with, or will result in a breach of, any of the terms and provisions
of, or has constituted or will constitute a default under, or has resulted in or will result in the creation or imposition of any lien, charge or encumbrance upon any property or assets of the Company pursuant to the terms of any contract or other
agreement to which the Company may be bound or to which any of the property or assets of the Company is subject, except for (i) such conflicts, breaches or defaults as have been duly waived in writing prior to the date hereof and (ii) such
conflicts, breaches and defaults that would not have a Material Adverse Effect; nor will any such action result (A) in any violation of the provisions of the organizational documents of the Company or any of its Subsidiaries, or (B) in any
material violation of the provisions of any Law applicable to the Company or any of its Subsidiaries or of any Governmental Authority having jurisdiction over the Company or any of its Subsidiaries.
(ss) Sanctions. Neither the Company nor any of its Subsidiaries, directors, officers, employees, agents, affiliates or other persons
acting on behalf of the Company or any of its Subsidiaries is currently the subject or the target of any sanctions administered by the Office of Foreign Assets Control of the U.S. Department of the Treasury or the U.S. Department of State, the
United Nations Security Council, the European Union, His Majestys Treasury of the United Kingdom or any other relevant sanctions authority (collectively, Sanctions); nor is the Company or any of its Subsidiaries located,
organized or resident in a country or territory that is the subject or the target of Sanctions, including, without limitation, the Crimea Region and the non-government controlled areas of the Zaporizhzhia and
Kherson Regions of Ukraine, the so-called Donetsk Peoples Republic, the so-called Luhansk Peoples Republic, Cuba, Iran, North Korea and Syria; and the
Company will not, directly or indirectly, use the proceeds of the 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 at the time of such financing, is the subject or the target 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. The Company and its Subsidiaries have 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.
(tt) Compliance with Laws. Each of the Company and its Subsidiaries: (i) is and at all times has been in compliance with all Laws,
statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product
manufactured or distributed by the Company or its Subsidiaries (Applicable Laws), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (ii) has not received any
FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any other Governmental Authority alleging or asserting noncompliance with any Applicable Laws or any licenses, certificates,
approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (Authorizations); (iii) possesses all material Authorizations and such Authorizations are valid and in full
force and effect and is not in material violation of any term of any such Authorizations; (iv) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any
Governmental Authority or third party alleging that any operation or activity relating to any of the Companys products is in violation of any Applicable Laws or Authorizations and has no knowledge that any such Governmental Authority or third
party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (v) has not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or
revoke any Authorizations and has no knowledge that any such Governmental Authority is considering such action; (vi) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims,
submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct
on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) has not, either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, market
withdrawal or replacement, safety alert, post-sale warning, dear healthcare provider letter or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to
the Companys knowledge, no third party has initiated, conducted or intends to initiate any such notice or action.
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