Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 23

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 23
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 require that we modify the design of our systems. If we are required to change our contract manufacturer,
we will be required to verify that the new manufacturer maintains facilities, procedures, and operations that comply with our quality
and applicable regulatory requirements, which could further impede our ability to manufacture Deep TMS systems in a timely manner. If
the change in manufacturer results in a significant change to any product, a new 510(k) clearance from the FDA or similar non-U. S. regulatory
authorization may be necessary before we implement the change, which could cause a substantial delay. We cannot assure you that we will
be able to identify and engage alternative suppliers or contract manufacturers on similar terms or without delay. Furthermore, our contract
manufacturer could require us to move to a different production facility. The occurrence of any of these events could harm our ability
to meet the demand for Deep TMS systems in a timely and cost-effective manner.

  14  

In addition, we rely, and expect to rely in the future,
on a network of third-party distributors and agents to market and distribute our products in international markets. We are assessing the
opportunity to continue expanding into other international markets. We may face significant challenges and risks in managing a geographically
dispersed distribution network. We have limited ability to control any third-party distributors and agents. Our distributors and agents
may be unable to successfully market, lease, and sell our products and may not devote sufficient time and resources to support the marketing,
sales, education, and training efforts that we believe enable the products to develop, achieve or sustain market acceptance. Additionally,
in some international jurisdictions, we rely on our distributors to manage the regulatory process, while complying with all applicable
rules and regulations, and we are dependent on their ability to do so effectively. Moreover, if a dispute arises with a distributor or
if a distributor is terminated by us or goes out of business, it may take time to locate an alternative distributor, to seek appropriate
regulatory approvals with the new distributor and to train new personnel to market our products, and our ability to sell those systems
in the region formerly serviced by such terminated distributor could be harmed. Any of these factors could reduce our revenues from affected
markets, increase our costs in those markets or damage our reputation. In addition, if an independent distributor or agent were to depart
and be retained by one of our competitors, we may be unable to prevent that distributor or agent from helping competitors solicit business
from our existing customers, which could further adversely