Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 591

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 591
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 the United States and international markets. We currently rely, and expect to continue to rely, on sole source third party
manufacturers to produce starting materials, substance, and final product, and to package and label LungFit® PH and our
product candidates. While we have identified and expect to qualify and engage back-up third party manufacturers as additional or alternative
suppliers for the commercial supply of LungFit® PH, we currently do not have such arrangements in place. Moreover, some
of these alternative manufacturers will have to be approved by the FDA before we can use them for manufacturing LungFit®
PH. It is also possible that supplies of materials that cannot be second-sourced can be managed with inventory planning. There can be
no assurance, however, that failure of any of our original sole source third-party manufacturers to meet our commercial demands for LungFit®
PH in a timely manner, or our failure to engage qualified additional or back-up suppliers for the commercial supply of LungFit®
PH, would not have a material adverse effect on commercialization of LungFit® and our business.

Supply
disruptions may result from a number of factors, including shortages in product raw materials, labor or technical difficulties, regulatory
inspections or restrictions, shipping or customs delays or any other performance failure by any third-party manufacturer on which we rely.
Any supply disruptions could disrupt sales of LungFit® PH and/or the timing of our clinical trials, which could have a
material adverse impact on our business. Furthermore, we may be required to modify our production methods to permit us to economically
manufacture our product for sale and our product candidates for clinical trials. These modifications may require us to re-evaluate our
resources and the resources of our third-party manufacturers, which could result in abrupt changes in our production methods and supplies.

In the
course of providing its services, a contract manufacturer may develop process technology related to the manufacture of our products or
product candidates that the manufacturer owns, either independently or jointly with us. This would increase our reliance on that manufacturer
or require us to obtain a license from that manufacturer in order to have LungFit® PH or our product candidates manufactured
by other suppliers utilizing the same process.

In the
year ended March 31, 2025, the Company purchased approximately 87% of its materials from a third-party vendor. In the year ended March
31, 2024, the Company purchased approximately 75% of its materials from a third-party vendor.

The failure
of our third-party