Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 49

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 49
---
 the permission
to affix the CE Mark does not ensure clearance or approval by regulatory authorities in other jurisdictions, and clearance or approval
by one or more foreign regulatory authorities does not ensure clearance or approval by the FDA, the EU and/or the regulatory authorities
in other foreign countries. However, a failure or delay in obtaining regulatory clearance or approval in one country may have a negative
effect on the regulatory process in others.

  28  

We are subject
to certain federal, state, and foreign fraud and abuse laws, health information privacy and security laws, and transparency laws, which,
if violated, could subject us to substantial penalties. Additionally, any challenge to or investigation into our practices under these
laws could cause adverse publicity and be costly to respond to, and thus could harm our business.

There are numerous U. S. federal and state, as well
as foreign, laws pertaining to healthcare fraud and abuse, including anti-kickback, false claims, physician self-referral, anti-inducement,
and physician transparency laws. Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare
laws and regulations involve substantial costs. Our business practices and relationships with providers and patients are subject to scrutiny
under these laws. We may also be subject to patient information privacy and security regulation by both the federal government and the
states and foreign jurisdictions in which we conduct our business. The healthcare laws and regulations that may affect our ability to
operate include:

  the federal healthcare Anti-Kickback Statute, which prohibits, among other things,                                                                   
  persons and entities 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, lease, order, or arrangement for, or recommendation  
  of, a good or service, for which payment may be made, in whole or in part, under federal healthcare programs, such as Medicare and Medicaid.         
  The term “remuneration” has been broadly interpreted to include anything of value. The federal 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 including items or services 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