Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 36

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 36
---
 or other requirements, we may be subject to regulatory, civil actions or penalties which could harm our business.

We purchase finished mazindol,
the molecule in both of Quilience and Nolazol, from a single third party, currently under a development agreement with us. In addition,
we do not have an agreement in place for, but we have identified, a secondary fill/finish supplier. There can be no guarantee that we
will enter into an agreement with such fill/finish supplier or that an effort to enter into such an agreement will be on favorable terms.
If we need to identify an additional fill/finish manufacturer, we would not be able to do so without delay and likely significant additional
cost.

Our existing manufacturer
and any future contract manufacturers may not perform as agreed or may not remain in the contract manufacturing business. In the event
of a natural disaster, business failure, strike or other difficulty, such as difficulties involving production yields, quality control
and quality assurance, we may be unable to replace a third-party manufacturer in a timely manner and the production of any product candidate
or commercialized drug would be interrupted, resulting in delays and additional costs.

In addition, because the contract
manufacturer of our drug substance is located in the United States, we may face difficulties in importing our drug substances into Europe
as a result of, among other things, import inspections, incomplete or inaccurate import documentation or defective packaging.

We and our collaborators and contract manufacturers
are subject to significant regulation with respect to manufacturing our product candidates. The manufacturing facilities on which we rely
may not continue to meet regulatory requirements and have limited capacity.

Manufacturers and their facilities
are required to comply with extensive regulatory requirements, including ensuring that quality control and manufacturing procedures conform
to cGMPs. These cGMP regulations cover all aspects of manufacturing relating to our product candidates. These regulations govern manufacturing
processes and procedures (including record keeping) and the implementation and operation of quality systems to control and assure the
quality of investigational product candidates and products approved for sale. Poor control of production processes can lead to the introduction
of contaminants or to inadvertent changes in the properties or stability of our product candidates that may not be detectable in final
product testing. We, our collaborators or our contract manufacturers must supply all necessary documentation in support of an NDA or MAA
on a timely basis and must adhere to GLP and cGMP QSR regulations enforced by the FDA and other regulatory authorities through their facilities
inspection program.