Company: NCEL
Filing Date: 2025-02-05
Form Type: F-3
Source: 0001213900-25-010223
Chunk: 72

Company: NewcelX Ltd.
Filing Date: 2025-02-05
Form: F-3
Chunk 72
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 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 are in violation of the law; |
| ● | seek an injunction or impose                                   
 administrative, civil or criminal penalties or monetary fines; |
| ● | 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 the product from the market;      |

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| ● | 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,