Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 284

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 284
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 we fail to comply with regulatory requirements
or experience unanticipated problems with our products, if approved.

Any marketing authorization that we receive for
any current or future drug candidate may be subject to limitations on the authorized indicated uses for which the product may be marketed
or the conditions of authorization or contain requirements for potentially costly post-market testing and surveillance to monitor the
safety and efficacy of the product. The FDA or comparable international regulatory authorities may also require a REMS or a comparable
international strategy, as a condition of approval of any drug candidate, which could include requirements for a medication guide, physician
communication plans or additional elements to assure safe use, such as restricted distribution methods, patient registries and other risk
minimization tools. If the FDA or a comparable international regulatory authority grants marketing authorization for a candidate, the
manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import and export
and record keeping for the candidate will be subject to extensive and ongoing regulatory requirements. These requirements include, among
others, submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMP
and GCP for any clinical trials that we conduct post-approval, and prohibitions on the promotion of an authorized product for unauthorized
indications or uses. The FDA and other or comparable international regulatory authorities actively enforce the laws and regulations prohibiting
the promotion of off-label uses, and a company that is found to have improperly promoted off-label may be subject to significant liability.
However, physicians may, in their independent medical judgment, prescribe legally available products for off-label uses. The FDA does
not regulate the behavior of physicians in their choice of treatments, but the FDA does restrict manufacturer’s communications on
the subject of off-label use of their 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