Company: NCEL
Filing Date: 2025-02-05
Form Type: F-3
Source: 0001213900-25-010223
Chunk: 76

Company: NewcelX Ltd.
Filing Date: 2025-02-05
Form: F-3
Chunk 76
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 by the federal government, or otherwise         
 restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require drug manufacturers 
 to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing            
 expenditures; and state laws governing the privacy and security of health information in certain circumstances, many of which differ        
 from each other in significant ways and may not have the same effect, thus complicating compliance efforts; and                             |
| ● | European and other foreign                                                                                                                  
 law equivalents of each of the laws, including reporting requirements detailing interactions with and payments to healthcare providers,     
 and the European General Data Protection Regulation, or GDPR, which contains provisions specifically directed at the processing of          
 health information, higher sanctions and extra-territoriality measures intended to bring non-EU companies under the regulation, including   
 companies like it that conduct clinical trials in the EU; Kadimastem anticipates that over time it may expand its business operations       
 to include additional operations in the EU and with such expansion, it would be subject to increased governmental regulation in the         
 EU countries in which it might operate, including the GDPR.                                                                                 |

The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable precedent and regulations. Federal and state enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. It is possible that governmental authorities will conclude that Kadimastem’s business practices do not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If Kadimastem’s operations are found to be in violation of any of these laws or any other related governmental regulations that may apply to it, Kadimastem may be subject to significant civil, criminal and administrative penalties, including, without limitation, damages, fines, imprisonment, disgorgement, exclusion from participation in government funded healthcare programs, such as Medicare and Medicaid, reputational harm, additional oversight and reporting obligations if Kadimastem becomes subject to a corporate integrity agreement or similar settlement to resolve allegations of non-compliance with these laws and the curtailment or restructuring of Kadimastem’s operations. If any of the physicians or other healthcare providers or entities with whom Kadimastem expects to do business is found to be not in compliance with applicable laws, they may be subject