Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 142

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 142
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 products. Similar considerations apply outside of the United States.

Later discovery of previously unknown problems
with any authorized product, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or
manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

●restrictions
                                            on the labeling, distribution, marketing or manufacturing of the product, withdrawal of the
                                            product from the market, or product recalls;

●untitled
                                            or warning letters from the FDA, or comparable notices of violation from comparable international
                                            regulatory authorities;

●imposition
                                            of clinical holds on ongoing clinical trials;

●refusal
                                            by the FDA or comparable international regulatory authorities to authorize pending applications
                                            or supplements to authorized applications we filed or suspension or revocation of marketing
                                            authorizations;

●requirements
                                            to conduct post-marketing studies or clinical trials;

●restrictions
                                            on coverage by third-party payors;

●fines,
                                            restitution or disgorgement of profits or revenues;

●suspension
                                            or withdrawal of marketing approvals;

●product
                                            seizure or detention, or refusal to permit the import or export of the product; and

●injunctions
                                            or the imposition of civil or criminal penalties.

The
FDA’s and other regulatory authorities’ policies may change, and additional government regulations may be enacted that could
prevent, limit or delay marketing authorization of a product. We cannot predict the likelihood, nature or extent of government regulation
that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt
to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance,
we may lose any marketing authorization that we may have obtained and we may not achieve or sustain profitability.

54

Non-compliance
with European Union requirements regarding safety monitoring or pharmacovigilance can also result in significant financial penalties.
Similarly, failure to comply with the European Union requirements regarding the protection of personal information can also lead to significant
penalties and sanctions.

Future
potential sales of our drug candidates may suffer if they are not accepted in the marketplace by physicians, patients and the medical
community.

There
is a risk that our drug candidates may not gain market acceptance among physicians, patients and the medical community, even if they
are approved by the regulatory authorities. The degree of market acceptance of any of our approved drug candidates will depend on a variety