Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 531

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 531
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 FDA may grant orphan drug designation to products that are intended to treat rare diseases
or conditions (i.e., those affecting fewer than 200,000 individuals in the U.S.), or diseases or conditions that affect more than 200,000
individuals in the U.S. but there is no reasonable expectation that the cost of developing and making the drug product would be recovered
from sales in the U.S. Although orphan drug designation does not convey any advantage in the regulatory review and approval process, it
can provide certain tax benefits and access to certain grants. Additionally, FDA user fees, which can be substantial, are waived for products
that obtain orphan drug designation. Further, if a product with orphan drug designation subsequently receives FDA approval for the designated
disease or condition, the product is generally granted seven years of orphan drug exclusivity, which (with certain limited exceptions)
blocks for seven years FDA approval of another product with the same active ingredient for the same indication. Orphan drug exclusivity
does not prevent the FDA from approving a different drug for the same disease or condition, or the same drug for a different disease or
condition.

Healthcare Fraud and Abuse
Laws. In addition to the FDA’s ongoing post-approval regulation of devices discussed above, manufacturers are also subject to
several other types of laws and regulations, subject to differing enforcement regimes. In recent years, marketing and promotional activities
regarding FDA-regulated products have come under intense scrutiny and have been the subject of enforcement action brought by the U.S.
Department of Justice and the Office of Inspector General of the Department of Health and Human Services, as well as state authorities
and even private individuals.

Healthcare providers, physicians
and third-party payors play a primary role in the recommendation and selection of medical devices for patients. Arrangements with third-party
payors and customers are subject to broadly applicable fraud and abuse and other healthcare laws and regulations. Such restrictions under
applicable federal and state healthcare laws and regulations include the following:

    ●
    The federal health care program Anti-Kickback Statute (“AKS”) prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or in return for purchasing, leasing, ordering or arranging for the purchase, lease or order of any good or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid.