Company: RGNT
Filing Date: 2025-09-30
Form Type: F-1/A
Source: 0001213900-25-093302
Chunk: 58

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-09-30
Form: F-1/A
Chunk 58
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 of interpretations to which they are subject, it is possible that some of our current or future      
 practices might be challenged under one or more of these laws, including, without limitation, our proposed Subscription Model, and         
 our advisory, consulting and royalty agreements with certain physicians who receive compensation, in part, in the form of stock or         
 stock options.                                                                                                                             |

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| ● | The federal civil False                                                                                                                 
 Claims Act prohibits, among other things, any person from knowingly presenting, or causing to be presented, a false or fraudulent       
 claim for payment of government funds, or knowingly making, using, or causing to be made or used, a false record or statement material  
 to an obligation to pay money to the government or knowingly concealing or knowingly and improperly avoiding, decreasing, or concealing 
 an obligation to pay money to the federal government. In recent years, several healthcare companies have faced enforcement actions      
 under the federal False Claims Act for, among other things, allegedly providing free product to customers with the expectation that     
 the customers would bill federal programs for the product or causing false claims to be submitted because of the company’s              
 marketing the product for unapproved, and thus non-reimbursable, uses. False Claims Act liability is potentially significant in the     
 healthcare industry because the statute provides for treble damages and mandatory penalties of tens of thousands of dollars per false   
 claim or statement. Healthcare companies also are subject to other federal false claims laws, including, among others, federal criminal 
 healthcare fraud and false statement statutes that extend to non-government health benefit programs.                                    |

| ● | 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