Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 50

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 50
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. Although there are a               
  number of statutory exceptions and regulatory safe harbors to the federal healthcare Anti-Kickback Statute protecting certain common business        
  arrangements and activities from prosecution or regulatory sanctions, the exceptions and safe harbors are drawn narrowly. Practices that             
  involve remuneration to those who prescribe, purchase, or recommend medical device products, including by providing discounts, or engaging           
  individuals as speakers, consultants, or advisors, may be subject to scrutiny if they do not fit squarely within an exception 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 reimbursement support programs, educational or research grants, or charitable           
  donations;                                                                                                                                           
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  the federal civil False Claims Act, which prohibits, among other things, individuals                                                            

  29  

  the federal Physician Self-Referral Law, commonly known as the Stark Law, which prohibits physicians                                           
  from referring Medicare and Medicaid patients to healthcare entities in which they or any of their immediate family members have ownership     
  interests or other financial arrangements, if these entities provide certain designated health services reimbursable by Medicare or Medicaid,  
  unless an exception applies. The Stark Law also prohibits entities that provide designated health services reimbursable by Medicare and        
  Medicaid from billing the Medicare and Medicaid programs for any items or services that result from a prohibited referral and requires         
  the entities to refund amounts received for items or services provided pursuant to the prohibited referral on a timely basis. Sanctions        
  for violating the Stark Law include denial of payment, civil monetary penalties and exclusion from the federal healthcare programs. Failure    
  to refund amounts received as a result of a prohibited referral on a timely basis may constitute a false or fraudulent claim and may result    
  in civil penalties and additional penalties under the federal False Claims Act;                                                                
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  the federal Anti-Inducement Law (also known as the Civil Monetary Penalties Law), which prohibits                                          
  a person from offering or transferring remuneration to a Medicare or State healthcare program beneficiary that the person knows or should  
  know is likely to influence the beneficiary’s selection of a particular provider, practitioner or supplier of any item