Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 110

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 110
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or in other countries, will be considered medically necessary or cost-effective for a specific indication, or that coverage or an adequate
level of reimbursement will be available.

The FDA and other regulatory authorities
actively enforce the laws and regulations prohibiting the promotion of off-label uses.

If any of Kadimastem’s
drug substances are approved and it is found to have improperly promoted off-label uses of those products and technology, Kadimastem may
become subject to significant liability. The FDA and other regulatory agencies strictly regulate the promotional claims that may be made
about prescription of its products and technology, if approved. If Kadimastem is found to have promoted such off-label uses, it may become
subject to significant liability. The federal government has levied large civil and criminal fines against companies for alleged improper
promotion of off-label use and has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies
enter into consent decrees, corporate integrity agreements or permanent injunctions under which specified promotional conduct must be
changed or curtailed. If Kadimastem cannot successfully manage the promotion of its products and technology, if approved, Kadimastem could
become subject to significant liability, which would materially adversely affect Kadimastem’s business and financial condition.

Kadimastem may be subject, directly or indirectly,
to federal and state healthcare fraud and abuse laws, false claims laws and health information privacy and security laws. If Kadimastem
is unable to comply, or have not fully complied, with such laws, it could face substantial penalties.

If Kadimastem obtains FDA
approval for any of its product candidates and begin commercializing those products in the United States, its operations may be directly
or indirectly through its customers, subject to various federal and state fraud and abuse laws, including, without limitation, the federal
Anti-Kickback Statute, the federal False Claims Act and physician sunshine laws and regulations. These laws may impact, among other things,
its proposed sales, marketing and education programs. In addition, Kadimastem may be subject to patient privacy regulation by both the
federal government and the states in which it conducts its business. The laws that may affect its ability to operate include:

  the federal Anti-Kickback Statute, which prohibits, among                                                                              

  federal civil and criminal false claims laws and civil monetary                                                                          

  the Health Insurance Portability and Accountability Act of 1996,                                                                      

  HIPAA, as amended