Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 590

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 590
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and supply issues. For example, if regulatory, manufacturing or other problems require one of these manufacturers or suppliers to discontinue
production at their respective facility, or if the equipment used for the production of LungFit® PH in these facilities
is significantly damaged or destroyed by fire, flood, earthquake, power loss or similar events, the ability of such manufacturer or supplier
to provide components needed for LungFit® PH, or to manufacture LungFit® PH may be significantly impaired.
In the event that these parties suffer a temporary or protracted loss of its facility or equipment, we would still be required to obtain
FDA approval to qualify a new manufacturer or supplier, as applicable, as an alternate manufacturer or source for the respective component
before any components manufactured by such manufacturer or by such supplier could be sold or used.

Any production
shortfall that impairs the supply of LungFit® PH or any of these components could have a material adverse effect on our
business, financial condition and results of operations and adversely affect our ability to satisfy demand for LungFit® PH,
which could adversely affect our product sales and operating results materially.

We depend on third-party
manufacturers, including sole source suppliers, to manufacture LungFit® PH and our product candidates and the materials
we require for our clinical trials. We may not be able to maintain these relationships and could experience supply disruptions outside
of our control.

We rely
on a network of third-party manufacturers to manufacture and supply LungFit® PH for commercial sale and post-certification/approval
clinical trials, and our product candidates for clinical trials and any commercial sales if they are approved. As a result of our reliance
on these third-party manufacturers and suppliers, including sole source suppliers of certain components of LungFit® PH
and our product candidates, we could be subject to significant supply disruptions, in particular, should any issues occur with our sole
source suppliers. Our supply chain for sourcing raw materials and manufacturing our products ready for distribution is a multi-step endeavor.
In some cases, third-party contract manufacturers supply us with raw materials, and contract manufacturers in the United States convert
these raw materials into substances from which we need to test our product’s final dosage. Establishing and managing this supply
chain requires a significant financial commitment and the creation and maintenance of numerous third-party contractual relationships.
Although we attempt to effectively manage the business relationships with companies in our supply chain, we do not have control over their
operations.

58

We require a supply of LungFit®
PH for sale in