Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 96

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 96
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 are subject to significant and ongoing regulation with respect to manufacturing its drug substances. The manufacturing facilities on which it relies 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 its 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 its product candidates that may not be detectable in final
product testing. We, its collaborators or its contract manufacturers must supply all necessary documentation in support of an BLA 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. Some of Kadimastem’s 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 its collaborators and third-party contractors must pass a pre-approval inspection for compliance with the applicable regulations as
a 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. Kadimastem 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 Kadimastem’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 Kadimastem may enter