Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 141

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 141
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 may also expose us to additional risks, including risks associated with the following, among
other things: additional international regulatory requirements; international exchange fluctuations; compliance with international manufacturing,
customs, shipment and storage requirements; the failure of enrolled subjects in international countries to adhere to clinical protocol
as a result of differences in standard-of-care; cultural differences in medical practice and clinical research; diminished protection
of intellectual property rights; and compliance with general local legal requirements.

53

Risks
Related to Commercialization of Our Drug Candidates

Even
if we receive marketing approval of a drug candidate, we will be subject to ongoing regulatory obligations and continued regulatory review,
which may result in significant additional expense and we may be subject to penalties if 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