(z) Except as described in the Registration Statement, the
Pricing Prospectus and the Prospectus, as applicable, the Company and its subsidiaries (i) are and at all times have been in compliance in all material respects with all Applicable Laws, as defined herein, applicable to the ownership, research,
testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company, including
the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the
criminal false statements and representations law (42 U.S.C. § 1320a-7b(a)), the civil monetary penalties laws (42 U.S.C. § 1320a-7a), the exclusion laws, the
Medicare statute (Title XVIII of the Social Security Act), the Medicaid statute (Title XIX of the Social Security Act), the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and
Clinical Health Act of 2009, the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, and the regulations promulgated pursuant to such laws and any other similar local, state,
federal, national, supranational and foreign laws and regulations relating to the regulation of the Company (collectively, the Applicable Laws), except for such non-compliance as would not,
individually or in the aggregate, have a Material Adverse Effect; (ii) have not received any FDA Form 483, written notice of adverse finding warning letter, untitled letter or other correspondence or written notice from any court or arbitrator
or governmental or regulatory authority alleging or asserting non-compliance with any Applicable Laws, except for such non-compliance as would not, individually or in
the aggregate, have a Material Adverse Effect; (iii) have not, to the Companys knowledge, 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 Applicable Laws and, in each case which, singly or in the aggregate, if the subject of an unfavorable decision,
ruling or finding, would have a Material Adverse Effect, nor, to the Companys knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (iv) have 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 and that 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), except where the failure to so file, obtain, maintain or
submit, or the failure of, such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments to be complete or accurate or corrected or supplemented by a subsequent submission, would not reasonably be
expected, individually or in the aggregate, to have a Material Adverse Effect; and (v) are 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;
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