Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 589

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 589
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 facility. Any
such remedial measures imposed upon us or third parties with whom we contract could materially harm our business. If we, our collaborators,
or any of our third-party manufacturers fail to maintain regulatory compliance, the FDA or comparable foreign regulatory authorities can
impose regulatory sanctions including, among other things, refuse to approve a pending application for a new product, withdrawal of a
certification or approval, suspend production, suspend clinical trials, require a recall or suspension of production. As a result, our
business, financial condition and results of operations may be materially harmed.

57

Additionally, if supply from one approved
manufacturer is interrupted, an alternative manufacturer would need to be qualified through a PMA Supplement or Marketing Authorization
Application amendment, or equivalent foreign regulatory filing, which could result in further delays. The regulatory authorities may
also require additional studies if a new manufacturer is relied on for commercial production. Switching manufacturers may involve substantial
costs and is likely to result in a delay in our desired clinical and commercial timelines.

These factors could cause us to
incur higher costs and could cause the delay or termination of clinical trials, regulatory submissions, required certification or approvals
or commercialization of our approved product or product candidates. Furthermore, if our suppliers fail to meet contractual requirements
and we are unable to secure one or more replacement suppliers capable of production at a substantially equivalent cost, our clinical trials
may be delayed or we could lose potential revenue.

If we encounter issues
with our contract manufacturers or suppliers, we may need to qualify alternative manufacturers or suppliers, which could impair our ability
to sufficiently and timely manufacture and supply LungFit® PH.

We currently
depend on contract manufacturers and suppliers for LungFit® PH and its components. Although we could obtain each of these
components from other third-party suppliers, we would need to qualify and obtain FDA approval for another contract manufacturer or supplier
as an alternative source for each such component, which could be costly and cause significant delays. Each of our current commercial manufacturing
and supply agreements include limitations on our ability to utilize alternative manufacturers or suppliers for these components above
certain specified thresholds during the terms of the agreements, which impairs our ability to fully implement any future manufacturing
strategies to prevent supply shortages or quality issues.

In addition,
some of our suppliers and contract manufacturers, including Spartronics and Medisize, conduct their manufacturing operations for us at
a single facility. Unless and until we qualify additional facilities, we may face limitations in our ability to respond to manufacturing