Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 72

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 72
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astem are in violation of the law;     |
| ● | seek an injunction or impose administrative, civil or criminal penalties or monetary fines; |
| ● | suspend or withdraw regulatory approval;                                                    |

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| ● | 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 the product from the market; |

| ● | refuse to permit the import or export of the products; or                                  |
| ● | refuse to allow Kadimastem to enter into supply contracts, including government contracts. |

Any government investigation
of alleged violations of law could require it to expend significant time and resources in response and could generate negative publicity.
The occurrence of any event or penalty described above may inhibit Kadimastem’s ability to commercialize its product candidates
and adversely affect its business, financial condition, results of operations and prospects.

International expansion of Kadimastem’s business exposes it to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States, within Israel, the EU and Japan.

Other than Kadimastem’s
headquarters and other operations which are located in Israel, it currently have limited international operations, but Kadimastem’s
business strategy incorporates potentially significant international expansion, particularly in anticipation of approval of its product
candidates. Kadimastem plans to maintain research and development, manufacturing, development, and sales representatives and conduct physician
and patient association outreach activities, as well as clinical trials, within and outside of the United States, in Israel, Europe. and
Japan. If Kadimastem’s products are approved for commercialization outside the United States, Israel, or the EU, Kadimastem will
likely enter into agreements with third parties to market its drug substances in these additional global territories. Kadimastem expects
that it will be subject to additional risks related to entering into or maintaining international business relationships, including:

| ● | different regulatory requirements for approvals of drug substances in foreign countries;                                                                                                                                                                                                                                  |
| ● | differing United States and foreign drug import and export rules, tariffs and other trade barriers;                                                                                                                                                                                                                       |
| ● | reduced protection for intellectual property rights in foreign countries;                                                                                                                                                                                                                                                 |
| ● | failure by Kadimastem to obtain regulatory approvals for the use of its products in various