Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 37

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 37
---
 us or working for
our competitors for a limited period. We may be unable to enforce these agreements under the laws of the jurisdictions in which our employees
work. For example, Israeli courts have required employers seeking to enforce covenants not to compete to demonstrate that the competitive
activities of a former employee will harm one of a limited number of material interests of the employer, such as the secrecy of a company’s
confidential commercial information or the protection of its intellectual property. If we cannot demonstrate that such an interest will
be harmed, we may be unable to prevent our competitors from benefiting from the expertise of our former employees and our competitiveness
may be diminished.

Risks Related
to Government Regulation

Our products and operations are subject to
extensive government regulation and oversight both in the United States and abroad, and our failure to comply with applicable requirements
or to obtain and/or maintain needed clearances could harm our business.

We are subject to extensive regulation in the United
States and elsewhere, including by the FDA, FTC, and their foreign counterparts. The FDA and foreign regulatory agencies regulate, among
other things, with respect to medical devices: design, development, and manufacturing; testing, labeling, content and language of instructions
for use and storage; clinical trials; product safety; marketing, sales and distribution; premarket clearance and approval; record keeping
procedures; advertising and promotion; recalls and field safety corrective actions; post-market surveillance, including reporting of deaths
or serious injuries and malfunctions that, if they were to recur, could lead to death or serious injury; post-market approval studies;
and product import and export.

  22  

The regulations to which we are subject are complex
and stringently enforced. Regulatory changes could result in restrictions on our ability to carry on or expand our operations, higher
than anticipated costs or lower than anticipated sales. The FDA enforces these regulatory requirements through, among other means, periodic
unannounced inspections. We do not know whether we will pass any future FDA inspections. Furthermore, various service offerings which
may be included under certain existing or potential pricing models, including but not limited to device operation services performed by
technicians engaged directly by us, could increase the risk profile and/or regulatory burden associated with our business. Failure to
comply with applicable regulations could jeopardize our ability to sell our products and result in enforcement actions such as: warning
letters; fines; injunctions; civil penalties; termination of distribution; recalls or seizures of products; delays in the introduction