Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 85

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 85
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 EU also have their own requirements for approval of product candidates with which Kadimastem must
comply prior to marketing in those countries. Obtaining foreign regulatory approvals and compliance with such foreign regulatory requirements
could result in significant delays, difficulties and costs for Kadimastem or its collaborators and could delay or prevent the introduction
of its current and any future products, in certain countries.

If Kadimastem or its collaborators
fail to receive applicable marketing approvals or comply with the regulatory requirements in international markets, its target market
will be reduced and its ability to realize the full market potential of its product candidates will be harmed and its business
will be adversely affected.

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If product liability lawsuits are brought against Kadimastem, it may incur substantial liabilities, even if Kadimastem has appropriate insurance policies, and it may be required to limit commercialization of its product candidates.

Kadimastem is exposed to potential
product liability and professional indemnity risks that are inherent in the research, development, manufacturing, marketing and use of
pharmaceutical products. Currently, it has no products that have been approved for marketing or commercialization; however, the use of
its product candidates in clinical trials, and the sale of these product candidates, if approved, in the future, may expose it to liability
claims. Product liability claims may be brought against Kadimastem or its partners by participants enrolled in its clinical trials, patients,
health care providers, pharmaceutical companies, its collaborators or others using, administering or selling any of its future approved
products. If Kadimastem cannot successfully defend itself against any such claims, it may incur substantial liabilities, even if Kadimastem
has product liability or such other applicable insurance policies in effect. Kadimastem may not be able to maintain adequate levels of
insurance for these liabilities at reasonable cost and/or reasonable terms. Excessive insurance costs or uninsured claims would add to
its future operating expenses and adversely affect its financial condition. As a result of such lawsuits and their potential results,
it may be required to limit commercialization of its product candidates. Regardless of the merits or eventual outcome, liability claims
may result in:

| ● | decreased demand for its drug substances and product candidates; |
| ● | termination of clinical trial sites or entire trial programs;    |

| ● | injury to its reputation and negative media attention;                                                                |
| ● | product recalls or increased warnings on product labels;                                                              |
| ● | withdrawal