Company: NCEL
Filing Date: 2025-03-31
Form Type: 425
Source: 0001213900-25-025889
Chunk: 165

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: 425
Chunk 165
---
 ordinary course. To the extent required by applicable laws and regulations
of the FDA or EMA, the Company or its applicable Subsidiary has submitted to the FDA and/or the EMA an Investigational New Drug Application
or amendment or supplement thereto for each clinical trial it has conducted or sponsored or is conducting or sponsoring; all such submissions
were in material compliance with applicable laws and rules and regulations when submitted and no material deficiencies have been asserted
by the FDA or EMA with respect to any such submissions, which, in each case, have not yet been remedied.

<div align='center'>17</div>

Section 5.20. Environmental Compliance. Except as set forth in the Commission Documents, the Company and its Subsidiaries (i) are in compliance with any and
all applicable Swiss and United States federal, state, local and foreign laws, rules, regulations, decisions and orders relating to the
protection of human health and safety to the extent relating to hazardous or toxic substances or wastes, pollutants or contaminants (“Hazardous Materials”), the environment or the presence, release, generation, use, management, handling, transportation, treatment,
storage, or disposal of Hazardous Materials (collectively, “Environmental Laws”); (ii) have received and are
in compliance with all permits, licenses or other approvals required of them under applicable Environmental Laws to conduct their respective
businesses; and (iii) have not received notice of any actual or potential liability for the investigation or remediation of any disposal
or release of Hazardous Materials, except, in the case of any of clauses (i), (ii) or (iii) above, for any such failure to comply, failure
to receive required permits, licenses, other approvals or liability as would not, individually or in the aggregate, reasonably be expected
to have a Material Adverse Effect.

Section 5.21. No Improper Practices. (i) Neither the Company nor the Subsidiaries, nor any director, officer, or employee of the Company or any
Subsidiary nor, to the Company’s knowledge, any agent, affiliate or other person acting on behalf of the Company or any Subsidiary
has, in the past five years, made any unlawful contributions to any candidate for any political office (or failed fully to disclose any
contribution in violation of applicable law) or made any contribution or other payment to any official of, or candidate for, any Swiss,
United States federal, state, municipal