Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 536

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 536
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 experts before they are placed on the market.

Continuing Regulation. As
in the U.S., manufacturers of medical devices are subject to comprehensive regulatory oversight by notified bodies and the competent authorities
of the EEA countries. This oversight applies both before and after certification. It includes control of compliance with the EU MDR General
Safety and Performance Requirements and post-market surveillance.

In the EEA, the advertising and
promotion of our products will also be subject to EEA countries national laws implementing Directive 2006/114/EC concerning misleading
and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other national legislation of individual
EEA countries governing the advertising and promotion of medical devices. EEA countries’ legislation may also restrict or impose
limitations on our ability to advertise our products directly to the general public. In addition, voluntary EU and national Codes of Conduct
provide guidelines on the advertising and promotion of our products to the general public and may impose limitations on our promotional
activities with healthcare professionals. Violations of the rules governing the promotion of medical devices in the EEA could be penalized
by administrative measures, fines and imprisonment.

Data Privacy Regulation.
The collection and use of personal health data in the EEA is governed by the data protection laws and regulations adopted by the EEA countries
and the EU General Data Protection Regulation (“GDPR”). The GDPR became applicable on May 25, 2018 and repealed the EU Data
Protection Directive. The GDPR is directly applicable in each EEA country and imposes several requirements on companies that process personal
data, strict rules on the transfer of personal data out of the EEA, including to the U.S., and fines and penalties for failure to comply
with the requirements of the GDPR and the related national data protection laws of the EAA countries. The GDPR confers a private right
of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain
compensation for damages resulting from violations of the GDPR. Failure to comply with the requirements of GDPR may result in fines of
up to 20,000,000 Euros or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, and other
administrative penalties.

28

Orphan Designation and Exclusivity.
In the EU, the Committee for Medicinal Products for Human Use grants orphan drug designation to promote the development of products that
are intended for the diagnosis, prevention or treatment