Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 769

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1A
Chunk 769
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 expensive to defend and could divert our management’s attention, result in substantial damage awards
against us, and harm our reputation.

The advertising and promotion
of our products in the EEA is subject to EEA countries’ national laws implementing Directive 2006/114/EC concerning misleading and
comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other national legislation of individual
EEA country governing the advertising and promotion of medical devices. EEA country legislation may also restrict or impose limitations
on our ability to advertise our products directly to the general public. In addition, voluntary EU and national Codes of Conduct provide
guidelines on the advertising and promotion of our products to the general public and may impose limitations on our promotional activities
with healthcare professionals.

We face extensive, ongoing regulatory requirements
and review, and our products may face future development and regulatory difficulties.

The holder of an approved PMA,
de novo authorization, or cleared 510(k) is subject to obligations to monitor and report adverse events and instances of the failure of
a product to meet the specifications in the marketing application. Application holders must submit new or supplemental applications and
obtain FDA approval for certain changes to the approved product, product labeling, or manufacturing process. Legal requirements have also
been enacted to require disclosure of clinical trial results on publicly available databases.

In addition, manufacturers of
FDA regulated products and their facilities are subject to continual review and periodic inspections by the FDA and comparable foreign
regulatory authorities for compliance with the FDA’s QSR and, as applicable, cGMP regulations. Our relationships with healthcare
providers, physicians and third-party payors must comply with FDA laws and regulations, the AKS, the FCA, HIPAA, various transparency
laws, and similar state and foreign laws. If products are made available to authorized users of the Federal Supply Schedule of the General
Services Administration and to low-income patients of certain hospitals, additional laws and requirements apply. Our activities are also
potentially subject to federal and state consumer protection and unfair competition laws. If we or our third-party collaborators fail
to comply with applicable regulatory requirements, a regulatory authority may take any of the following actions:

    ●
    conduct an investigation into our practices and any alleged violation of law;

    ●
    issue warning letters or untitled letters asserting that we are in violation of the law;

    ●
    seek an injunction or impose civil or criminal penalties or monetary fines;

    ●
    suspend or withdraw