Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 537

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 537
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 of life-threatening or chronically debilitating conditions affecting not more
than five in 10,000 persons in the EU Community and for which no satisfactory method of diagnosis, prevention or treatment has been authorized
(or the product would be a significant benefit to those affected). Additionally, designation is granted for products intended for the
diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition and when, without incentives,
it is unlikely that sales of the drug in the EU would be sufficient to justify the necessary investment in developing the medicinal product.

In the EU, orphan drug designation
entitles a party to financial incentives such as reduction of fees or fee waivers and ten years of market exclusivity is granted following
medicinal product approval. This period may be reduced to six years if the orphan drug designation criteria are no longer met, including
where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity.

Orphan drug designation must be
requested before submitting an application for marketing approval. Orphan drug designation does not convey any advantage in, or shorten
the duration of, the regulatory review and approval process.

Exceptional Circumstances/Conditional
Approval. Orphan medicinal product or products for unmet medical needs may be eligible for EU approval under exceptional circumstances
or with conditional approval. Approval under exceptional circumstances is applicable to orphan products and is used when an applicant
is unable to provide comprehensive data on the efficacy and safety under normal conditions of use because the indication for which the
product is intended is encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence, when
the present state of scientific knowledge does not allow comprehensive information to be provided, or when it is medically unethical to
collect such information. Conditional marketing authorization is applicable to orphan medicinal products, medicinal products for seriously
debilitating or life- threatening diseases or medicinal products to be used in emergency situations in response to recognized public threats.
Conditional marketing authorization can be granted on the basis of less complete data than is normally required in order to meet unmet
medical needs and in the interest of public health, provided the risk-benefit balance is positive, it is likely that the applicant will
be able to provide the comprehensive clinical data, and unmet medical needs will be fulfilled.

Conditional marketing authorization
is subject to certain specific obligations to be reviewed annually.

Other Regulations. We are
also subject to numerous federal, state and local laws relating to such matters as safe working conditions, manufacturing practices, environmental
protection, fire