Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 47

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 47
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 manner or cost-effectively.

We cannot assure you that
we will be able to secure alternative equipment and materials and utilize such equipment and materials without experiencing interruptions
in our workflow. If we should encounter delays or difficulties in securing, reconfiguring or revalidating the equipment and components
we require for our implant systems, our reputation, business, financial condition and results of operations could be negatively impacted.

We currently rely, and plan to rely in the
future, on third parties to conduct and support our portions of our preclinical studies and clinical trials. If these third parties do
not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain marketing authorization
or certification of or commercialize our product candidates.

We have utilized and plan
to continue to utilize and depend upon independent investigators and collaborators, such as medical institutions, CROs, contract manufacturing
organizations, or CMOs, and strategic partners to conduct and support portions of our preclinical studies and clinical trials under agreements
with us.

We expect to have to negotiate
budgets and contracts with CROs, trial sites and CMOs and we may not be able to do so on favorable terms, which may result in delays to
our development timelines and increased costs. We will rely heavily on these third parties over the course of our preclinical studies
and clinical trials, and we control only certain aspects of their activities. As a result, we will have less direct control over the conduct,
timing and completion of these preclinical studies and clinical trials and the management of data developed through preclinical studies
and clinical trials than would be the case if we were relying entirely upon our own staff. Nevertheless, we are responsible for ensuring
that each of our studies is conducted in accordance with applicable protocol, legal and regulatory requirements and scientific standards,
and our reliance on third parties does not relieve us of our regulatory responsibilities. We and these third parties are required to comply
with GCP requirements, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for product
candidates in clinical development. Regulatory authorities enforce these GCP requirements through periodic inspections of trial sponsors,
principal investigators and trial sites.

If we or any of these third
parties fail to comply with applicable GCP regulations, the clinical data generated in our clinical trials may be deemed unreliable and
the FDA or comparable foreign regulatory authorities or other bodies may require us to perform additional clinical trials before approving
our marketing applications or certifications. We cannot assure you that,