Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 37

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 37
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 Some of our contract manufacturers have never produced a commercially approved pharmaceutical product and therefore
have not obtained the requisite regulatory authority approvals to do so. The facilities and quality systems of some or all of our collaborators
and third-party contractors must pass a pre-approval inspection for compliance with the applicable regulations as a condition of regulatory
approval of our product candidates or any of our other potential product candidates. In addition, the regulatory authorities may, at any
time, audit or inspect a manufacturing facility involved with the preparation of our product candidates or our other potential product
candidates or the associated quality systems for compliance with the regulations applicable to the activities being conducted. We do not
control the manufacturing process of, and are completely dependent on, our 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 our contract manufacturers 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 our business.

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

We may seek collaboration
arrangements with pharmaceutical or biotechnology companies for the development or commercialization of our current and potential future
product candidates. We may enter into these arrangements on a selective basis depending on the merits of retaining commercialization rights
for ourselves 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. We will face, to the extent that we decide to enter into collaboration
agreements, significant competition in seeking appropriate collaborators. Moreover, collaboration arrangements are complex and time consuming
to negotiate, document and implement. We may not be successful in our efforts to establish and implement collaborations or other alternative
arrangements should we so choose to enter into such arrangements. The terms of any collaborations or other arrangements that we may establish
may not be favorable to us.

Disagreements between parties
to a collaboration arrangement regarding clinical development and commercialization matters can lead to delays in the development process
or commercializing the