Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 311

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 311
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 of personal data from the EU to us in the U.S. will require greater
scrutiny and assessments as required under Schrems II and may have an adverse impact on cross-border transfers of personal data or increase
costs of compliance.

Applicable data privacy and data protection laws
may conflict with each other, and by complying with the laws or regulations of one jurisdiction, we may find that we are violating the
laws or regulations of another jurisdiction. Despite our efforts, we may not have fully complied in the past and may not in the future.
That could require us to incur significant expenses, which could significantly affect our business. Failure to comply with data protection
laws may expose us to risk of enforcement actions taken by data protection authorities or other regulatory agencies, private rights of
action in some jurisdictions, and potential significant penalties if we are found to be non-compliant. Furthermore, the number of government
investigations related to data security incidents and privacy violations continue to increase and government investigations typically
require significant resources and generate negative publicity, which could harm our business and reputation.

67

Our business activities may be subject to the Foreign Corrupt
Practices Act (“FCPA”) and similar anti-bribery and anti-corruption laws of other countries in which we operate.

We intend to initiate studies in countries other
than the United States. Our business activities may be subject to the FCPA and similar anti-bribery or anti-corruption laws, regulations
or rules of other countries in which we operate. The FCPA generally prohibits offering, promising, giving or authorizing others to give
anything of value, either directly or indirectly, to a non-U.S. government official in order to influence official action or otherwise
obtain or retain business. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect
the transactions of the corporation and to devise and maintain an adequate system of internal accounting controls. Our business is heavily
regulated and therefore involves significant interaction with public officials, including officials of non-U.S. governments. Additionally,
in many other countries, the healthcare providers who prescribe pharmaceuticals are employed by their governments, and the purchasers
of pharmaceuticals are government entities; therefore, our dealings with these prescribers and purchasers are subject to regulation under
the FCPA. Recently the SEC and U.S. Department of Justice have increased their FCPA enforcement activities with respect to biotechnology
and pharmaceutical companies. There is no certainty that all of our employees