Compliance. The Company is not subject to the Employee Retirement Income Security Act of 1974, as amended, or the
regulations and published interpretations thereunder.
with Laws. The Company: (A) is and at all times has been in compliance with all statutes, rules, or regulations
applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling,
promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company
(“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result
in a Material Adverse Effect; (B) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter
or other correspondence or notice from the FDA or any other governmental authority alleging or asserting noncompliance with any
Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto
required by any such Applicable Laws (“Authorizations”); (C) possesses all material Authorizations and such
Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations;
(D) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action
from any governmental authority or third party alleging that any product operation or activity is in violation of any Applicable
Laws or Authorizations and has no knowledge that any such governmental authority or third party is considering any such claim,
litigation, arbitration, action, suit, investigation or proceeding; (E) has not received notice that any governmental authority
has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and has no knowledge that
any such governmental authority is considering such action; and (F) has 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 Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements
or amendments were complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).
Issuer. As of the time of filing of the Registration Statement, as of the date of this Agreement and as of the Closing
Date or any Option Closing Date, the Company was not, is not, and will not be, an “ineligible issuer” as defined in
Rule 405 under the Securities Act.
Private Issuer. The Company is a “foreign private issuer,” as such term is defined in Rule 405 of the
Data. The statistical and market-related data included in each of the Registration Statement, the Pricing Disclosure
Package and the Prospectus are based on or derived from sources that the Company reasonably and in good faith believes are reliable
and accurate or represent the Company’s good faith estimates that are made on the basis of data derived from such sources.
2.38. Subsidiaries. Subject
to any prohibitions or restrictions under any applicable corporate or other similar laws, no Subsidiary is currently prohibited,
directly or indirectly, from paying any dividends to the Company, from making any other distribution on such Subsidiary’s