Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 155

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 155
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 FDA clearance or approval for a product, we must obtain authorization before commencing clinical trials or obtain marketing
authorization or approval of our products under the comparable regulatory authorities of countries outside of the United States. The marketing
authorization process varies from country to country and the time may be longer or shorter than that required for FDA clearance or approval.

We also have received European Conformity (CE) marking
in the European Economic Area (EEA) and in Israel for MDD, OCD, and smoking addiction, and 11 other indications in psychiatry, addiction
treatment, and neurology. Additional regulatory approvals have also been obtained for Deep TMS in various other existing and potential
territories, including, for example, in Canada and India. Sales and marketing of medical devices outside of the United States are subject
to foreign regulatory requirements that vary widely from country to country. The time required to obtain appropriate marketing authorizations
from other foreign authorities may be longer or shorter than that required for FDA approval. Whether or not we have obtained FDA approval,
our Deep TMS systems may be subject to different regulatory requirements in other jurisdictions. The foreign regulatory approval process
includes all the risks associated with FDA regulation, as well as country-specific risks and regulations.

  90  

Employees

Our employees include professionals with extensive
experience in medical device development and applications, neurology and psychopathology, pre-clinical experimentation, clinical development,
and business development. As of December 31, 2024, we had 120 employees, of which 49 were based in the United States and 71 were based
outside of the United States (in Israel). Our U. S. employee base includes 47 employees in sales, marketing, and service/operations, 1
employee in medical affairs, and 1 general and administrative employee. Our Israeli employee base includes 31 employees in clinical trials,
research and development, production, quality control, and service/operations, 6 employees in sales and marketing, and 34 general, administrative
and operations employees.

While none of our employees are party to any collective
bargaining agreements, certain provisions of the collective bargaining agreements between the Histadrut (General Federation of Labor in
Israel) and the Coordination Bureau of Economic Organizations (including the Industrialists’ Associations) are applicable to our
employees by order of the Israel Ministry of Labor. Such orders are part of the employment related laws and regulations which apply to
our employees and set certain mandatory terms of employment. Such mandatory terms