Governmental Permit will not be renewed, except where such revocation, modification, suspension, termination, invalidation or nonrenewal would not, singularly or in the aggregate, have a Material
Adverse Effect.
The Company and its subsidiaries, and to the Companys Knowledge, its directors, officers, employees
or agents, each in their respective roles with the Company, are and have been in compliance in all material respects with applicable federal, state, local and foreign health care regulatory laws, including without limitation, laws related to fraud
and abuse, payment transparency, and privacy and security of protected health information (collectively, Health Care Laws). The Company and its subsidiaries have not received written notice of any claim, action, suit,
proceeding, hearing, enforcement, investigation, arbitration or other action from any court, arbitrator or governmental or regulatory authority or third party alleging that the Company, its subsidiaries or its personnel have violated any applicable
Health Care Law, nor, to the Companys Knowledge, has any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action been threatened, which, individually or in the aggregate, might result in any
Material Adverse Effect.
The studies, tests and preclinical or clinical trials conducted by or on behalf of the Company
that are described in the SEC Reports (the Company Studies and Trials) were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where
applicable, accepted professional scientific standards; the descriptions of the results of the Company Studies and Trials contained or incorporated by reference in the Registration Statement, the Prospectus and the Prospectus Supplement are accurate
in all material respects; the Company has no knowledge of any other studies or trials not described in the SEC Reports, the results of which are inconsistent with or call in question the results described or referred to in the SEC Reports; and the
Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental authority exercising comparable authority requiring the termination, suspension or material modification of any Company Studies and
Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Companys Knowledge, there are no reasonable grounds for the same.
Except as disclosed in the SEC Reports, the Company has not granted rights to develop, manufacture, produce, assemble,
distribute, license, market or sell its products or product candidates to any other person and is not bound by any agreement that affects the exclusive right of the Company to develop, manufacture, produce, assemble, distribute, license, market or
sell its products or product candidates.
(dd) Stock Option Plans. Except as
described in the SEC Reports, there are no options, warrants, restricted stock units, agreements, contracts or other rights in existence to purchase or acquire from the Company or any subsidiary of the Company any shares of the capital stock of the
Company or any subsidiary of the Company. The description of the Companys stock option, stock bonus and other stock plans or arrangements (the Company Stock Plans), and the options (the
Options) or other rights granted thereunder, set forth in the SEC Reports accurately and fairly presents the information required to be shown with
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