Company: NCEL
Filing Date: 2025-03-31
Form Type: 425
Source: 0001213900-25-025889
Chunk: 162

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: 425
Chunk 162
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 the Company’s knowledge,
no such actions, suits, proceedings, audits or investigations are threatened or contemplated by any Governmental Authority or threatened
by others; and except as would not be reasonably expected, individually or in the aggregate, to have a Material Adverse Effect, there
are no current or pending audits or investigations, actions, suits or proceedings by or before any Governmental Authority that are required
under the Securities Act to be described in the Commission Documents that are not so described.

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Section 5.14. Compliance with Law. Each of the Company and its Subsidiaries: (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 or its
Subsidiaries (“Applicable Laws”); (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 (including, without limitation,
the EMA) 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; (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