Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 528

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 528
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 present or any future third-party manufacturers or
suppliers will be able to comply with QSR or other FDA regulatory requirements to the agency’s satisfaction. Failure to comply with
these obligations may lead to possible legal or regulatory enforcement action by the FDA.

The FDA has broad regulatory compliance
and enforcement powers. If the FDA determines that we failed to comply with applicable regulatory requirements, it can take a variety
of compliance or enforcement actions, which may result in any of the following sanctions:

    ●
    untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;

    ●
    unanticipated expenditures to address or defend such actions;

    ●
    customer notifications or repair, replacement, refunds, recall, detention or seizure of our products;

    ●
    operating restrictions, partial suspension or total shutdown of production;

    ●
    refusing or delaying our requests for regulatory approvals or clearances of new products or modified products;

    ●
    withdrawing a PMA that has already been granted;

    ●
    refusal to grant export approval for our products; or

    ●
    criminal prosecution.

Advertising and Promotion.
The FDA and comparable foreign regulatory authorities closely regulate the post-approval marketing and promotion of medical devices, including
standards and regulations for direct-to-consumer advertising, communications about unapproved uses, industry- sponsored scientific and
educational activities and promotional activities involving the internet. Devices may be marketed only for the approved or cleared indications
and in accordance with the provisions of the approved or cleared label.

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Healthcare providers are permitted
to prescribe approved devices for “off-label” uses—that is, uses not approved by the FDA and therefore not described
in the product’s labeling. These off-label uses are common across medical specialties. Physicians may believe that such off-label
uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice
of treatments. The FDA does, however, impose stringent restrictions on manufacturers’ communications regarding off-label use. Thus,
we may market our products, if approved by the FDA, only for their approved indications, but under certain conditions may engage in non-promotional,
balanced communication regarding off-label uses. Failure to comply with applicable FDA requirements and restrictions in this area may
subject us to adverse publicity and a variety of sanctions, which could harm our business and financial condition.

Combination Products. A
combination product is the combination of two or more regulated components, i.e., drug/device, bi