Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 71

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 71
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 cell therapy product candidates or the products or product candidates of others that are cell-based; and |

| ● | the cost of Kadimastem’s products and the reimbursement policies of government and private third party payers. |

If the health care community
does not accept Kadimastem’s potential products for any of the foregoing reasons, or for any other reason, it could affect its sales,
having a material adverse effect on Kadimastem’s business, financial condition and results of operations.

Even if Kadimastem 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 Kadim