be expected to have a Material Adverse Effect; (vi) has no knowledge of any event that has occurred which allows, or after notice or lapse of time would reasonably be expected to allow,
revocation, termination, or other impairment of any Regulatory Authorization, except for such revocations, terminations or impairments as would not, whether individually or in the aggregate, reasonably be expected to have a Material Adverse Effect;
(vii) has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any applicable Health Care Laws or Regulatory Authorizations and
all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were materially corrected or supplemented by a subsequent submission)
except where the failures to file, obtain, maintain, submit or correct the same would not, whether individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; (viii) is not a party to or have any ongoing
reporting obligations pursuant to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any applicable
Regulatory Authority; and (ix) along with its employees, officers and directors, and, to the Companys knowledge, agents, has not been excluded, suspended or debarred from participation in any government health care program or human
clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion. The term Health
Care Laws means all health care laws related to the research, investigation, development, production, testing, packaging, labeling, distribution, storage, marketing, advertising, promotion, sale, export, import, use, handling, safety,
efficacy, or manufacturing of pharmaceutical and biological products, including, without limitation, 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.; the
regulations promulgated pursuant to such laws; and any comparable foreign, federal, state and local laws and regulations.
(kk) Studies, tests and trials. All pre-clinical and clinical (if any) studies,
tests and trials conducted by or on behalf of, or sponsored by, the Company or its subsidiaries, or in which the Company or its subsidiaries have participated with respect to their product candidates, including without limitation any such studies,
tests and trials that are described in the Registration Statement, the Prospectus and the Pricing Disclosure Package, or the results of which are referred to in the Registration Statement, the Prospectus and the Pricing Disclosure Package, as
applicable, were, and if still pending are, being conducted in all material respects in accordance with all applicable Health Care Laws, Regulatory Authorizations and any applicable rules, regulations and policies to which such studies, tests or
trials are subject. The descriptions of the results from such studies, tests and trials contained in the Registration Statement, the Prospectus and the Pricing Disclosure Package are accurate in all material respects, and the Company has no
knowledge of any other studies, tests or trials not described in the Registration Statement, the Prospectus and the Pricing Disclosure Package, the results of which are inconsistent with or otherwise reasonably call into question the results
described or referred to in the Registration Statement, the Prospectus and the Pricing Disclosure Package. Neither the Company nor its subsidiaries has received any written notices, correspondence or other communications from any Regulatory
Authority, institutional review board or other entity having authority over the conduct of such studies, tests, or trials requiring or threatening the termination, material modification, clinical hold or suspension of any such studies, tests or
trials being conducted or proposed to be conducted by or on behalf of the Company or its subsidiaries, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies, tests or
trials, and, to the Companys knowledge, there are no reasonable grounds for the same.