Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 48

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 48
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 upon inspection, such regulatory authorities will determine that
any of our clinical trials comply with the GCP regulations. In addition, our product candidates must be produced in accordance with cGMP
requirements known as the QSR, or similar foreign requirements. Our failure or any failure by these third parties to comply with these
regulations or to recruit a sufficient number of patients may require us to repeat clinical trials, which would delay the marketing authorization
or certification process. Moreover, our business may be implicated if any of these third parties violates federal, state or foreign fraud
and abuse or false claims laws and regulations or healthcare privacy and security laws.

Any third parties conducting
or supporting portions of our clinical trials will not be our employees and, except for remedies available to us under our agreements
with such third parties, we cannot control whether or not they devote sufficient time and resources to our product candidates. These third
parties may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical
trials, or other product development activities, which could affect their performance on our behalf. If these third parties do not successfully
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 obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for
other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to complete development of, obtain marketing
authorizations or certifications for or successfully commercialize our product candidates. As a result, our financial results and the
commercial prospects for our product candidates would be adversely affected, our costs could increase and our ability to generate revenue
could be delayed.

Switching or adding third
parties to conduct or support portions of our preclinical studies and clinical trials involves substantial cost and requires extensive
management time and focus. In addition, there is a natural transition period when a new third party commences work. As a result, delays
occur, which can materially impact our ability to meet our desired clinical development timelines.

If we or third parties, such as CROs or
trial sites, use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages.

Our research and development
activities involve the controlled use of potentially hazardous substances, including radiological materials, by us or third parties, such
as CROs and CMOs. Our use of radioactive