Company: RGNT
Filing Date: 2025-10-24
Form Type: F-1/A
Source: 0001213900-25-101900
Chunk: 58

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-10-24
Form: F-1/A
Chunk 58
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time and capital, distract management from operating our business and may harm our reputation and financial results.

Our relationships with customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

Physicians, other healthcare
providers, and third-party payors will play a primary role with respect to any future products for which we obtain marketing approval.
Our arrangements with third-party payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws
and regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute
our product.

Restrictions under applicable
federal and state healthcare laws and regulations include the following:

| ● | The U.S. federal healthcare                                                                                                                
 program Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving          
 or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for,       
 or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole or in part, under federal        
 healthcare programs such as Medicare and Medicaid. Although there are a number of statutory exemptions and regulatory safe harbors         
 protecting certain common activities from prosecution, the exemptions and safe harbors are drawn narrowly and practices that involve       
 remuneration to 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