Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 105

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 105
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 or services
to individuals in the United Kingdom, or to monitor their behavior will be subject to the UK GDPR - the requirements of which are (at
this time) largely aligned with those under the EU GDPR and as such, may lead to similar compliance and operational costs with potential
fines of up to £17.5 million or 4% of annual global revenues. On June 28, 2021, the European Commission issued a decision that the
United Kingdom ensures an adequate level of protection for personal data transferred under the EU GDPR from the European Union to the
United Kingdom. In June of 2021, the European Commission issued a decision, which will sunset on June 27, 2025 without further action,
that the United Kingdom ensures an adequate level of protection for personal data transferred under the EU GDPR from the EU to the United
Kingdom. The Parliament of the United Kingdom is currently considering the Data Protection and Digital Information Bill to harmonize the
2018 Data Protection Act, UK GDPR, and the Privacy and Electronic Communications Regulations under one legislative framework.

Australia

In Australia, the relevant regulatory body responsible
for the pharmaceutical industry is the TGA. As with the EMA and FDA there is a harmonization and collaboration between regulatory authorities.
The TGA requires notification of all clinical trials via an electronic submission of a Clinical Trial Notification prior to commencing
the clinical trial.

33

Third-Party Payer Coverage and Reimbursement

Although our drug candidates have not been commercialized
for any indication, if they are approved for marketing, the commercial success of our drug candidates will depend, in part, upon the availability
of coverage and reimbursement from third-party payers at the federal, state and private levels.

In the United States and internationally, sales
of any product that we market in the future, and our ability to generate revenues from such sales, are dependent, in significant part,
on the availability of adequate coverage and reimbursement from third-party payors, such as government healthcare programs, such as Medicare
and Medicaid, managed care providers, private insurance plans and other organizations.

Third-party payors are increasingly challenging
the price of medical products and services and have implemented cost-cutting and reimbursement initiatives and likely will continue to
do so in the future. In addition, significant uncertainty exists as to the reimbursement status of newly approved healthcare products.
The process for determining whether a payor will provide coverage for a product may be separate from the process for setting the price
or reimbursement rate that the payor