written notices, correspondence or other communications from any Regulatory Authority or any other governmental entity requiring or threatening the termination, modification or suspension of any
studies or trials that are described in the Registration Statement, the Time of Sale Prospectus and the Prospectus or the results of which are referred to in the Registration Statement, the Time of Sale Prospectus and the Prospectus, and, to the
Companys Knowledge, there are no reasonable grounds for the same.
(x) Required Reports and
Records. (i) the Company and its Subsidiaries have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health
Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were, in all material respects, timely, complete, accurate and not misleading on the date filed (or were corrected
or supplemented by a subsequent submission); (ii) neither the Company nor its Subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or
arbitrator or Regulatory Authority, other governmental entity or third party alleging that any Company, Subsidiary, or product operation or activity is in violation of any Health Care Laws, including, without limitation, any FDA Form 483, notice of
adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any other Regulatory Authority or governmental entity, nor, to the Companys Knowledge, is any such claim, action, suit, proceeding, hearing,
enforcement, investigation, arbitration or other action threatened; (iii) neither the Company nor its Subsidiaries are a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar
agreements with or imposed by any Regulatory Authority or other governmental entity; and (iv) neither the Company, its Subsidiaries nor any of their respective employees, officers or directors has been excluded, suspended or debarred from
participation in any U.S. federal health care program or human clinical research or, to the Knowledge of the Company, is subject to an inquiry, investigation, proceeding or other similar action by a Regulatory Authority or other governmental entity
that could reasonably be expected to result in debarment, suspension, or exclusion.
(y) Tax Law
Compliance. The Company and each of its Subsidiaries have filed all federal, state, local and foreign tax returns required to be filed through the date of this Agreement or have obtained extensions thereof (except where the failure to file would
not, individually or in the aggregate, reasonably be expected to have a material adverse effect) and have paid all taxes required to be paid thereon (except for cases in which the failure to file or pay would not, individually or in the aggregate,
reasonably be expected to have a material adverse effect, or, except as currently being contested in good faith and for which reserves required by U.S. GAAP have been created in the financial statements of the Company), and no unpaid tax deficiency
has been determined adversely to the Company or any of its Subsidiaries which has had (nor does the Company nor any of its Subsidiaries have any notice or Knowledge of any unpaid tax deficiency which could reasonably be expected to be determined
adversely to the Company or its Subsidiaries and which could reasonably be expected to have) a material adverse effect.
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