Company: RGNT
Filing Date: 2025-07-07
Form Type: F-1/A
Source: 0001213900-25-061821
Chunk: 59

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-07-07
Form: F-1/A
Chunk 59
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| ● | The Health Insurance Portability                                                                                                          
 and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of         
 2009, or HITECH, imposes criminal and civil liability for knowingly and willfully executing a scheme to defraud any healthcare benefit    
 program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement        
 in connection with the delivery of or payment for healthcare benefits, items or services. In addition, HIPAA, as amended by HITECH,       
 and their respective implementing regulations impose obligations, including mandatory contractual terms, on covered healthcare providers, 
 health plans, as well as their business associates, with respect to safeguarding the privacy, security and transmission of individually   
 identifiable health information.                                                                                                          |

| ● | The Physician Payment Sunshine                                                                                                       
 Act, implemented as the Open Payments program, requires manufacturers of certain products reimbursed by Medicare, Medicaid, or the   
 Children’s Health Insurance Program to track and report to the federal government payments and transfers of value that they          
 make to physicians and teaching hospitals, certain other healthcare professionals beginning in 2022, group purchasing organizations, 
 and ownership interests held by physicians and their families, and provides for public disclosures of these data. Manufacturers are  
 required to submit annual reports to the government and failure to do so may result in civil monetary penalties for all payments,    
 transfers of value and ownership or investment interests not reported in an annual submission, and may result in liability under     
 other federal laws and regulations.                                                                                                  |

| ● | Many states have adopted                                                                                                               
 laws and regulations analogous to the federal laws cited above, including state anti-kickback and false claims laws, which may apply   
 to items or services reimbursed under Medicaid and other state programs or, in several states, regardless of the payer. Several states 
 have enacted legislation requiring medical device companies to, among other things, establish marketing compliance programs; file      
 periodic reports with the state, including reports on gifts and payments to individual health care providers; make periodic public     
 disclosures on sales, marketing, pricing, clinical trials and other activities; and/or register their sales representatives. Some      
 states prohibit specified sales and marketing practices, including the provision of gifts, meals, or other items to certain health     
 care providers.                                                                                                                        |

Efforts to ensure that our
business arrangements with third parties will comply with applicable healthcare laws and regulations involve substantial costs. Additionally,
it is possible that