Company: NCEL
Filing Date: 2025-03-31
Form Type: 425
Source: 0001213900-25-025889
Chunk: 174

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: 425
Chunk 174
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 Subsidiaries has failed to file with the applicable Governmental
Authorities (including, without limitation, the FDA, the EMA or any foreign, federal, state, provincial or local Governmental Authority
performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission,
except for such failures that, as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect;
except as disclosed in the Commission Documents, all such filings, declarations, listings, registrations, reports or submissions were
in compliance with applicable laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect
to any such filings, declarations, listings, registrations, reports or submissions that have not yet been remedied, except for any deficiencies
that, as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect. The Company has operated
and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable
rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority exercising comparable authority. The
Company has no knowledge of any studies, tests or trials not described in the Commission Documents the results of which reasonably call
into question in any material respect the results of the studies, tests and trials described in the Commission Documents.

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Section 5.41. Clinical Studies. The preclinical studies and tests and clinical trials described in the Commission Documents were, and, if still pending,
are, being conducted in all material respects in accordance with the experimental protocols, procedures and controls pursuant to, where
applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the
Company; the descriptions of such studies, tests and trials, and the results thereof, contained in the Commission Documents are accurate
and complete in all material respects; the Company is not aware of any tests, studies or trials not described in the Commission Documents,
the results of which reasonably call into question the results of the tests, studies and trials described in the Commission Documents;
and, except as described in the Commission Documents, the Company has not received any written notice or correspondence from the FDA,
the EMA or any foreign, state or local Governmental Authority exercising comparable authority or any institutional review board or comparable
authority requiring the termination, suspension, clinical hold or material modification of any tests, studies