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

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 25
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 plans may not be realized, or if realized, may not
be successful. We expect each market to have particular regulatory hurdles to overcome, and future developments in these markets, including
the uncertainty relating to governmental policies and regulations, could harm our business. In addition, the sale, lease, and shipment
of our Deep TMS systems across international borders, as well as the purchase of components and products from international sources, subjects
us to extensive U. S. and other foreign governmental trade, import, export, regulatory, and customs regulations and laws. Compliance with
these regulations and laws is costly and exposes us to penalties for non-compliance. We expect our international activities will be dynamic
over the foreseeable future as we continue to pursue opportunities in international markets.

  15  

Our international business operations are subject
to a variety of risks, including but not limited to difficulties in staffing and managing foreign and geographically dispersed operations,
to the extent we establish non-U. S. operations; differing and multiple payer reimbursement regimes, government payors or patient self-pay
systems; difficulties in determining and creating the proper sales pathway in new, international markets; compliance with various U. S.
and international laws and regulations, including export control laws and the U. S. Foreign Corrupt Practices Act of 1977 (FCPA) and similar
international laws, anti-money laundering laws and differing regulatory requirements for obtaining marketing authorizations for our products
in non-U. S. jurisdictions; changes in, or uncertainties relating to, foreign rules and regulations that may impact our ability to sell
our products, perform services or repatriate profits to the United States; tariffs and trade barriers, export regulations, sanctions,
and other regulatory and contractual limitations on our ability to sell our products in certain foreign markets; potential adverse tax
consequences, including imposition of limitations on or increase of withholding and other taxes on remittances and other payments by foreign
subsidiaries or joint ventures; imposition of differing labor laws and standards; armed conflicts or economic, political, and/or social
instability in foreign countries and regions; fluctuations in foreign currency exchange rates; supply lags, inefficiencies, difficulty
managing expenses in our local currency in the event that its value diverges from that of the currencies of the jurisdictions where we
earn income, and other risks created by any sourcing, manufacture, assembly and/or production of our products/components outside of the
U. S., while commercial activities are largely focused in the U. S.; an inability, or