Company: NCEL
Filing Date: 2025-03-31
Form Type: 425
Source: 0001213900-25-025889
Chunk: 41

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: 425
Chunk 41
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the Swiss Code of Obligation.

(nn) . The Company and the Subsidiaries: (A) are and at all times have been in material compliance with all Applicable Laws including
but not limited to statutes, rules and 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 under development,
manufactured or distributed by the Company or the Subsidiaries, (b) have not received any Form 483 from the FDA or similar notice from
the EMA, notice of adverse finding, warning letter, or other written correspondence or notice from the FDA, the EMA, or any other federal,
state, local or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or
any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such
Applicable Laws (“”), which would, individually or in the aggregate, result in a Material Adverse Effect;
(C) possess all material Authorizations and such Authorizations are valid and in full force and effect and neither the Company nor the
Subsidiaries is in material violation of any term of any such Authorizations; (D) have not received written notice of any claim, action,
suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, the EMA, or any other federal, state,
local or foreign governmental or regulatory authority or third party alleging that any Company product, operation or activity is in material
violation of any Applicable Laws or Authorizations and has no knowledge that the FDA, the EMA, or any other federal, state, local or foreign
governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation
or proceeding against the Company; (E) have not received notice that the FDA, EMA, or any other federal, state, local or foreign governmental
or regulatory authority that (i) it has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations;
contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging
of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of