Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 565

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 565
---
 impact our business, financial condition and results of operations.

We may be subject to regulatory or enforcement
actions if we engage in improper marketing or promotion of our approved product or product candidates.

Our educational and promotional
activities and training methods must comply with FDA and other applicable laws, including the prohibition of the promotion of a medical
device for a use that has not been cleared or approved by the FDA. Use of a device outside of its cleared or approved indications is known
as “off-label” use. Physicians may use our products off-label in their professional medical judgment, as the FDA does not
restrict or regulate a physician’s choice of treatment within the practice of medicine. However, if the FDA determines that our
educational and promotional activities or training constitutes promotion of an off-label use, it could request that we modify our training
or promotional materials or subject us to regulatory or enforcement actions, including the issuance of warning letters, untitled letters,
fines, penalties, injunctions, or seizures, any of which could have an adverse impact on our reputation and financial results.

43

It is also possible that other
federal, state or comparable foreign regulatory authorities might take action if they consider our educational and promotional activities
or training methods to constitute promotion of an off-label use, which could result in significant fines or penalties under other statutory
authorities, such as laws prohibiting false claims for reimbursement. In that event, our reputation could be damaged, and adoption of
the products could be impaired. Although our policy is to refrain from statements that could be considered off-label promotion of our
products, the FDA or comparable foreign regulatory authorities could disagree and conclude that we have engaged in off-label promotion.
It is also possible that other federal, state or comparable foreign regulatory authorities might take action, including, but not limited
to, through a whistleblower action under the FCA, if they consider our business activities constitute promotion of an off-label use, which
could result in significant penalties, including, but not limited to, criminal, civil or administrative penalties, treble damages, fines,
disgorgement, exclusion from participation in government healthcare programs, reporting requirements and compliance oversight if we become
subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, and the curtailment
or restructuring of our operations. In addition, the off-label use of our products may increase the risk of product liability claims.
Product liability claims are expensive to defend and could divert our management’s attention, result in substantial damage