Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 24

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 24
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 affect our sales. As a result of our reliance on third-party distributors and
agents, we may be subject to disruptions and increased costs due to factors beyond our control, including labor strikes, third-party error,
and other issues. If the services of any of our distributors or agents become unsatisfactory, we may experience delays in meeting our
customers’ demands, and we may be unable to find a suitable replacement on a timely basis or on commercially reasonable terms. Any
failure to deliver products or services in a timely manner may damage our reputation and could cause us to lose existing or potential
customers.

We also rely on third parties in our clinical trials,
which are managed by our own staff and personnel as well as by certain third parties, including clinical trial sites, medical institutions,
clinical research organizations, or CROs, and private practices, for, among other things, site monitoring, statistical work, and electronic
data capture. Nevertheless, we are responsible for ensuring that each of our clinical trials is conducted in accordance with applicable
protocols, and legal, regulatory, and scientific standards, including current good clinical practices, or cGCPs, which are set forth in
regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for clinical trials. If we or any such third
parties fail to comply with applicable cGCPs, the clinical data generated in such trials may be deemed unreliable and the FDA or comparable
foreign regulatory authorities may require us to perform additional clinical trials before granting a marketing authorization for any
particular indication. In addition, if such third parties do not devote sufficient time and resources to our clinical trials or otherwise
fail to carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or
accuracy of the clinical data they assist in obtaining is compromised due to the failure to adhere to our clinical protocols, regulatory
requirements or for other reasons, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory
authorization for or successfully commercialize Deep TMS for a specified indication.

We face risks
associated with our international business.

We currently market and sell Deep TMS systems outside
of the United States in various countries and/or intend to market and expand the commercialization of Deep TMS in other international
markets, including Canada, Europe, Australia, and various Middle Eastern, Central/South American, and Asian countries. We are also assessing
the opportunity to expand into other international markets. However, our expansion