Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 111

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 111
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 by the Health Information Technology and                                                                                    
  Clinical Health Act, and its implementing regulations, which imposes certain requirements relating to the privacy, security and transmission  
  of individually identifiable health information;                                                                                              
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  the federal physician sunshine requirements under the Patient                                                                         
  Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, requires manufacturers of drugs,  
  devices and medical supplies to report annually to the U. S. Department of Health and Human Services information related to payments  
  and other transfers of value to physicians, other healthcare providers and teaching hospitals and ownership and investment interests  
  held by physicians and other healthcare providers and their immediate family members and applicable group purchasing organizations;   
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  state law equivalents of each of the above federal laws, such                                                                              
  as anti-kickback and false claims laws that may apply to items or services reimbursed by any third-party payor, including commercial       
  insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines    
  and the relevant compliance guidance promulgated 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                                                                                 
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  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