Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 93

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 93
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under Medicaid and other state programs, or, in several states, apply regardless of the payor. Some state laws require pharmaceutical
companies to comply with the pharmaceutical industry’s voluntary compliance guidelines, or the relevant compliance guidance promulgated
by the federal government, in addition to requiring drug manufacturers to report information related to payments to physicians and other
healthcare providers or marketing expenditures to the extent that those laws impose requirements that are more stringent than the Physician
Payments Sunshine Act. State and international laws also govern the privacy and security of health information in some circumstances,
many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

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Due to the breadth of these laws and the narrowness of their exceptions
and safe harbors, it is possible that business activities can be subject to challenge under one or more of such laws. The scope and enforcement
of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of
the lack of applicable precedent and regulations. Federal and state enforcement bodies have recently increased their scrutiny of interactions
between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements
in the healthcare industry.

Ensuring that business arrangements with third
parties comply with applicable healthcare laws and regulations is costly and time consuming. If business operations are found to be in
violation of any of the laws described above or any other applicable governmental regulations a pharmaceutical manufacturer may be subject
to penalties, including civil, criminal and administrative penalties, damages, fines, disgorgement, individual imprisonment, exclusion
from governmental funded healthcare programs, such as Medicare and Medicaid, contractual damages, reputational harm, diminished profits
and future earnings, additional reporting obligations and oversight if subject to a corporate integrity agreement or other agreement to
resolve allegations of non-compliance with these laws, and curtailment or restructuring of operations, any of which could adversely affect
a pharmaceutical manufacturer’s ability to operate its business and the results of its operations.

Data Privacy and Security in the United States

We are subject to laws
and regulations governing data privacy and the protection of personal information including health information in the United States. The
legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing focus on privacy
and data protection issues which will continue to affect our business. In the United States, we may be subject to state security breach
notification laws, state laws