Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 789

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1A
Chunk 789
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 maintaining market acceptance of the particular product candidate, if approved, and could significantly harm our
business, results of operations and prospects.

Risks Related to our Reliance on Third Parties

We rely on third parties to conduct our preclinical
studies and clinical trials and perform other tasks for us. If these third parties do not successfully carry out their contractual duties,
meet expected deadlines or comply with regulatory requirements, we may not be able to obtain certification or regulatory approval for
or commercialize our approved product or product candidates and our business could be substantially harmed.

We have relied on and plan to
continue to rely on third-party CROs to monitor and manage data for our ongoing preclinical and clinical programs. We rely on these parties
for execution of our preclinical studies and clinical trials, and we directly control only certain aspects of their activities, although
from a regulatory perspective we are responsible for their actions. We are responsible for ensuring that each of our studies is conducted
in accordance with the applicable protocol, legal, regulatory and scientific standards and our reliance on the CROs does not relieve us
of our regulatory responsibilities. We and our CROs and other vendors are required to comply with GCP, QSR and GLP, which are regulations
and guidelines enforced by the FDA, the competent authorities of the EEA countries, and comparable foreign regulatory authorities for
all of our product candidates in clinical development. Regulatory authorities enforce these regulations through periodic inspections of
study sponsors, principal investigators, study sites and other contractors. If we or any of our CROs or vendors fail to comply with applicable
regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory
authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that
upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials comply with
GCP regulations. In addition, our clinical trials must be conducted with products that are produced under QSR regulations. Our failure
to comply with these regulations may require us to repeat clinical trials, which would delay the certification or regulatory approval
process, or have other adverse consequences.

If any of our relationships with
these third-party CROs terminate, we may not be able to enter into arrangements with alternative CROs or do so on commercially reasonable
terms. In addition, our CROs are not our employees, and except for remedies available to us under our agreements with such C