Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 129

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 129
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 condition of regulatory approval of its product candidates or any of its other potential product candidates. In addition, the regulatory
authorities may, at any time, audit or inspect a manufacturing facility involved with the preparation of its product candidates or its
other potential product candidates or the associated quality systems for compliance with the regulations applicable to the activities
being conducted. The combined company does not control the manufacturing process of, and are completely dependent on, its contract manufacturing
partners for compliance with the regulatory requirements. If these facilities do not pass a pre-approval plant inspection, regulatory
approval of the product candidates may not be granted or may be substantially delayed until any violations are corrected to the satisfaction
of the regulatory authority, if ever. Moreover, if the combined company’s contract manufacturer’s fail to achieve and maintain
high manufacturing standards, in accordance with applicable regulatory requirements, or there are substantial manufacturing errors, this
could result in patient injury or death, product shortages, product recalls or withdrawals, delays or failures in product testing or delivery,
cost overruns or other problems that could seriously harm its business.

Any collaboration arrangements that the
combined company may enter into in the future may not be successful, which could adversely affect its ability to develop and commercialize
its current and potential future product candidates.

The combined company may seek
collaboration arrangements with pharmaceutical or biotechnology companies for the development or commercialization of its current and
potential future product candidates. It may enter into these arrangements on a selective basis depending on the merits of retaining commercialization
rights for the combined company as compared to entering into selective collaboration arrangements with other pharmaceutical or biotechnology
companies for each product candidate, both in the United States and internationally. It will face, to the extent that the combined
company decides to enter into collaboration agreements, significant competition in seeking appropriate collaborators. Moreover, collaboration
arrangements are complex and time consuming to negotiate, document and implement. The combined company may not be successful in its efforts
to establish and implement collaborations or other alternative arrangements should the combined company so choose to enter into such arrangements.
The terms of any collaborations or other arrangements that the combined company may establish may not be favorable to itself.

Disagreements between parties
to a collaboration arrangement regarding clinical development and commercialization matters can lead to delays in the development process
or commercializing the applicable product candidate and, in some cases, termination of the collaboration arrangement. These disagreements
can be difficult to resolve if neither of the parties has final decision-making authority.

Collaborations with pharmaceutical
or