Company: NCEL
Filing Date: 2025-03-31
Form Type: 425
Source: 0001213900-25-025889
Chunk: 164

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: 425
Chunk 164
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 be disclosed by the Company in reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported
within the time periods specified in the Commission’s rules and forms, including controls and procedures designed to ensure that
such information is accumulated and communicated to the Company’s management as appropriate to allow timely decisions regarding
required disclosure. The Company has carried out any evaluations of the effectiveness of its disclosure controls and procedures as required
by Rule 13a-15 of the Exchange Act.

Section 5.19. Permits.
Except as disclosed in the Commission Documents, the Company and its Subsidiaries have made all filings, applications and submissions
required by, possesses and is operating in compliance with, all approvals, licenses, certificates, certifications, clearances, consents,
grants, exemptions, marks, notifications, orders, permits and other authorizations issued by, the appropriate federal, state or foreign
Governmental Authority (including, without limitation, the United States Food and Drug Administration (the “FDA”),
the United States Drug Enforcement Administration, the European Medical Agency (“EMA”), or any other foreign,
federal, state, provincial, court or local government or regulatory authorities including self-regulatory organizations engaged in the
regulation of clinical trials, pharmaceuticals, biologics or biohazardous substances or materials) necessary for the ownership or lease
of their respective properties or to conduct its businesses as described in the Commission Documents (collectively, “Permits”),
except for such Permits the failure of which to possess, obtain or make the same would not reasonably be expected, individually or in
the aggregate, to have a Material Adverse Effect; the Company and its Subsidiaries are in compliance with the terms and conditions of
all such Permits, except where the failure to be in compliance would not have a Material Adverse Effect; all of the Permits are valid
and in full force and effect, except where any invalidity, individually or in the aggregate, would not be reasonably expected to have
a Material Adverse Effect; and neither the Company nor any of its Subsidiaries has received any written notice relating to the limitation,
revocation, cancellation, suspension, modification or non-renewal of any such Permit which, individually or in the aggregate, if the subject
of an unfavorable decision, ruling or finding, would have a Material Adverse Effect, or has any reason to believe that any such license,
certificate, permit or authorization will not be renewed in the