Company: RGNT
Filing Date: 2025-09-30
Form Type: F-1/A
Source: 0001213900-25-093302
Chunk: 59

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-09-30
Form: F-1/A
Chunk 59
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 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 governmental authorities will conclude that our business practices may not comply with current or future statutes,
regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to
be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil,
criminal and administrative penalties, damages, fines, exclusion from government funded healthcare programs, such as Medicare and Medicaid,
and the curtailment or restructuring of our operations. Exclusion, suspension and debarment from government funded healthcare programs
would significantly impact our ability to commercialize, sell or distribute any product. If any of the physicians or other providers
or entities with whom we expect to do business are found not to be in compliance with applicable laws, they may be subject to criminal,
civil or administrative sanctions, including exclusions from government funded healthcare programs.

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