Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 156

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 156
---
AA, thus
complicating compliance efforts.

61

Efforts to ensure that our business arrangements
with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental
authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving
applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws
or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties,
damages, fines, imprisonment, exclusion of our drug candidates from government funded healthcare programs, such as Medicare and Medicaid,
and the curtailment or restructuring of our operations. If any of the physicians or other healthcare providers or entities with whom we
expect to do business is found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative
sanctions, including exclusions from government funded healthcare programs.

Changes in U.S. healthcare law and implementing regulations,
as well as changes in healthcare policy, may impact our business in ways that we cannot currently predict and may harm our business and
results of operations.

All aspects of our business, including R&D,
manufacturing, marketing, pricing, sales, litigation, and intellectual property rights, are subject to extensive legislation and regulation.
Changes in applicable U.S. federal and state laws and agency regulation, as well as international laws and regulations, could have a materially
negative impact on our business. In the United States and in some other jurisdictions, there have been a number of legislative and regulatory
changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of our drug candidates or
any potential future drug candidates of ours, restrict or regulate post-approval activities, or affect our ability to profitably sell
any drug candidates for which we obtain marketing approval. Increased scrutiny by the U.S. Congress of the FDA’s approval process
may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing
and other requirements. Congress also must reauthorize the FDA’s user fee programs every five years and often makes changes to those
programs in addition to policy or procedural changes that may be negotiated between the FDA and industry stakeholders as part of this
periodic reauthorization process. Congress most recently reauthorized the user fee programs in September 2022 without any substantive
policy changes.

Among policy makers and payors in the United