Company: RGNT
Filing Date: 2025-07-07
Form Type: F-1/A
Source: 0001213900-25-061821
Chunk: 58

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-07-07
Form: F-1/A
Chunk 58
---
 those who prescribe, purchase, or recommend medical devices, including certain discounts, or engaging consultants          
 as speakers or consultants, may be subject to scrutiny if they do not fit squarely within the exemption or safe harbor. Our practices      
 may not in all cases meet all of the criteria for safe harbor protection from anti- kickback liability. Moreover, there are no safe        
 harbors for many common practices, such as educational and research grants. Liability may be established without a person or entity        
 having actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it. In addition, the government may assert      
 that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent 
 claim for purposes of the civil False Claims Act. Due to the breadth of these laws, the narrowness of statutory exceptions and regulatory  
 safe harbors available, and the range 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.                                                                                                                             |

<div align='center'>39</div>

| ● | 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.                                    |