Company: NCEL
Filing Date: 2025-03-31
Form Type: 425
Source: 0001213900-25-025889
Chunk: 42

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: 425
Chunk 42
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, requests
the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to,
any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv)
enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of
permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations
by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect; (vii)
and has no knowledge that the FDA, EMA, or any other federal, state, local or foreign governmental or regulatory authority is considering
any of the foregoing such actions (F) have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications,
records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations except where the failure
to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result
in a Material Adverse Effect, and that 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 corrected or supplemented by a subsequent submission).

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The properties, business and
operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and
regulations of the FDA and EMA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or
use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern
as to approving or clearing for marketing any product being developed or proposed to be developed by the Company. The Company has established
and administers a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the
Company in complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA, the EMA, and
any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the
FDA or EMA); except