Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 56

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 56
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 an adverse effect on our
business and profitability.

Our employees,
consultants, distributors, agents, and other commercial partners may engage in misconduct or other improper activities, including non-compliance
with regulatory standards and requirements.

We are exposed to the risk that our employees, consultants,
distributors, agents, and other commercial partners may engage in inappropriate, fraudulent or illegal activity. Misconduct by these parties
could include intentional, reckless or negligent conduct or other unauthorized activities that violate the regulations of the FDA and
other U. S. healthcare regulators, as well as non-U. S. regulators, including by violating laws requiring the reporting of true, complete
and accurate information to such regulators, manufacturing standards, healthcare fraud and abuse laws and regulations in the United States
and abroad or laws that require the true, complete, and accurate reporting of financial information or data. In particular, sales, marketing,
and business arrangements in the healthcare industry, including the sale of medical devices, are subject to extensive laws and regulations
intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or
prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs, and other business
arrangements. It is not always possible to identify and deter misconduct by our employees, distributors, agents, and other third parties,
and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses
or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or
regulations. Efforts to ensure that the activities of these parties will comply with applicable healthcare laws and regulations involve
substantial costs. These risks may be more pronounced, and we may find that the processes and policies we have implemented are not effective
at preventing misconduct. If any actions are instituted against us and we are not successful in defending ourselves or asserting our rights,
those actions could result in the imposition of significant fines or other sanctions, including the imposition of civil, criminal and
administrative penalties, damages, monetary fines, individual imprisonment, disgorgement, possible exclusion from participation in government
healthcare programs, additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement
to resolve allegations of non-compliance with these laws, contractual damages, reputational harm, diminished profits and future earnings
and the curtailment of our operations. Whether or not we