Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 613

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 613
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 marketing and promotion, sales commission, customer incentive programs and other business
arrangements. Employee misconduct could also involve the improper use of information obtained in the course of clinical trials, which
could result in regulatory sanctions and serious harm to our reputation. The precautions we take to detect and prevent this activity may
not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions
or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us,
and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business,
including the imposition of significant fines or other sanctions.

We are subject to applicable
fraud and abuse laws, including anti-kickback and false claims, transparency, health information privacy and security and other healthcare
laws. Failure to comply with such laws may result in substantial penalties.

We are subject to broadly applicable
healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we conduct research,
market, sell and distribute any product candidates for which we obtain marketing approval. The healthcare laws that may affect us include:
the federal fraud and abuse laws, including the federal anti-kickback, and false claims and civil monetary penalties laws; federal data
privacy and security laws; and federal transparency laws related to ownership and investment interests and payments and/or other transfers
of value made to or held by physicians (including doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals
and, information regarding payments and transfers of value provided to and other healthcare professionals during the previous year. In
addition, many states have similar laws and regulations that may differ from each other and federal law in significant ways, thus complicating
compliance efforts. Moreover, several states require biopharmaceutical companies to comply with the biopharmaceutical industry’s
voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government and may require medical device
manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing
expenditures. Additionally, some state and local laws require the registration of biopharmaceutical sales representatives in the jurisdiction.

Ensuring that our operations and
future business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs.
It is possible that governmental authorities will conclude that our business practices, including our relationships with physicians and
other healthcare providers