defined in clause (ii) below), and there have been no material recalls, field notifications, field corrections, market withdrawals or replacements, dear doctor letters, or safety
alerts relating to an alleged material lack of safety, efficacy or regulatory compliance of any of the Companys products; (ii) the Company and each of its subsidiaries is and has been in material compliance with statutes, laws,
ordinances, rules and regulations applicable to the Company and its subsidiaries and their respective activities, including for the ownership, testing, research, development, manufacture, quality, safety, packaging, use, distribution, marketing,
labeling, advertising, promotion, sale, offer for sale, storage, record-keeping, import, export or disposal of any product developed, manufactured or distributed by the Company, including the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §
301, et seq.), the Public Health Service Act (42 U.S.C. § 201 et seq.), and comparable laws of other governmental entities and the regulations promulgated pursuant to such laws (collectively, Applicable Laws); (iii) neither the
Company nor any of its subsidiaries has received notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental entity or third party alleging that any product, operation
or activity is in material violation of any Applicable Laws or Permits or has any knowledge that any such governmental entity or third party has threatened any such claim, litigation, arbitration, action, suit, investigation or proceeding;
(iv) the Company and each of its subsidiaries has timely 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 Permits and, to the Companys knowledge, all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, correct and not misleading in all material respects
on the date filed (or were corrected or supplemented by a subsequent submission). To the Companys knowledge, since January 1, 2020, neither the Company, any subsidiary nor any of its directors, officers, employees or agents, has made, or
caused the making of, any material false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other governmental entity. To the Companys
knowledge, since January 1, 2020, neither the Company, any of its subsidiaries nor any of its directors, officers, employees, agents, employees or affiliates have committed any act, made any statement or failed to make any statement that would
reasonably be expected to provide a basis for the FDA or any other governmental or regulatory authority to invoke its policy with respect to Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities, or similar
policies, set forth in any Health Care Law (as defined below).
(yy) Except to the extent disclosed in each of the
Registration Statement, the Disclosure Package or the Prospectus, (i) each of the Company and its subsidiaries is and has been, since January 1, 2019, in material compliance with all applicable healthcare laws and regulations, including,
without limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the civil False
Claims Act (31 U.S.C. §§ 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the federal Physician Payment Sunshine Act (42 U.S.C. §
1320a-7h), all criminal laws relating to health care fraud and abuse, the exclusion laws (42 U.S.C. § 1320a-7), the Medicare statute (Title XVIII of the Social
Security Act), the Medicaid statute (Title XIX of the Social Security Act), all applicable federal, state, local laws governing scope and permissible interactions between pharmaceutical manufacturers and health care providers, laws governing
government pricing or price reporting programs and regulations promulgated thereunder,
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