Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 149

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 149
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 abuse and other healthcare
laws and regulations that may affect its business or the financial arrangements and relationships through which it markets, sells and
distributes its products. Even if a medical device manufacturer does not control referrals of healthcare services or bill directly to
Medicare, Medicaid or other third-party payors, federal, and state healthcare laws and regulations are applicable to its business. In
addition, portions of our business may be subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). To the extent
we provide any covered entity customers with services that involve the use or disclosure of protected health information (PHI) we may
be required to enter into business associate agreements. Business associates are also directly liable for compliance with HIPAA. The laws
that may affect a medical device manufacturer’s ability to operate include, but are not limited to:

  86  

  the federal healthcare Anti-Kickback Statute, which prohibits, among other things,                                                                
  persons and entities from knowingly and willfully soliciting, receiving, offering or providing remuneration (broadly interpreted to include       
  anything of value), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual     
  for, or the purchase, lease, order, or arrange for or recommend a good or service for which payment may be made, in whole or in part,             
  under a federal healthcare program, such as Medicare and Medicaid. The government can establish a violation of the Anti-Kickback Statute          
  without proving that a person or entity had actual knowledge of the law or a specific intent to violate. Moreover, the government may             
  assert that a claim for reimbursement that includes items resulting from a violation of the federal healthcare Anti-Kickback Statute constitutes  
  a false or fraudulent claim for purposes of the federal civil False Claims Act. 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 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