Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 105

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 105
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imastem obtains regulatory approval
for a product candidate, its products will remain subject to ongoing regulatory oversight.

Even if Kadimastem
obtains any regulatory approval for its product candidates, they will be subject to ongoing regulatory requirements for
manufacturing (including manufacturing sites), labeling, packaging, storage, advertising, promotion, sampling, record-keeping and
submission of safety and other post-market information. Any regulatory approvals that it receives for its product candidates also
may be subject to a REMS, limitations on the approved indicated uses for which the product may be marketed or to the conditions of
approval or contain requirements for potentially costly post-marketing manufacturing site improvements and testing, including
Phase 4 clinical trials, and surveillance to monitor the quality, safety and efficacy of the product. The holder of an approved
BLA also must submit new or supplemental applications and obtain FDA approval for certain changes to the approved product,
manufacturing facility, product labeling or manufacturing process. Advertising and promotional materials must comply with FDA rules
and are subject to FDA review, in addition to other potentially applicable federal and state laws.

In addition, product manufacturers
and their facilities are subject to payment of user fees and continual review and periodic inspections by the FDA and other regulatory
authorities for compliance with current good manufacturing practices, or cGMP, requirements and adherence to commitments made in the BLA
or foreign marketing application. If Kadimastem, or a regulatory authority, discover previously unknown problems with a product, such
as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured or disagrees
with the promotion, marketing or labeling of that product, a regulatory authority may impose restrictions relative to that product, the
manufacturing facility or Kadimastem, including requiring recall or withdrawal of the product from the market or suspension of manufacturing.

If Kadimastem fails to comply
with applicable regulatory requirements, a regulatory authority may:

  issue an untitled letter or warning letter that Kadimastem  

  seek an injunction or impose administrative, civil or criminal  

  suspend or withdraw regulatory approval;  

  suspend any ongoing clinical trials;  

  refuse to approve pending applications or supplements to applications;  

  restrict the marketing or manufacturing of the product;  

  seize or detain the products or require the withdrawal of  

  refuse to permit the import or export of the products; or  

  refuse to allow Kadimastem to enter into supply contracts,  

Any government investigation
of alleged violations of