Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 297

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 297
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I, II, III, IV substances with Schedule III substances presenting the lowest relative risk of abuse among such substances and Schedule
I and IV substances considered to present the highest risk of abuse. The UN Conventions require signatories to require all people manufacturing,
trading (including exporting and importing) or distributing controlled substances to obtain a license from the relevant authority. Each
individual export or import of a controlled substance must also be subject to authorization. The obligations provided in the UN Conventions
and additional requirements are implemented at a national level, and requirements may vary from one member state to another. In order
to develop and commercialize our products in the EU, we need to comply with the national requirements related to controlled substances
which are costly and may affect our development plans in the EU.

Failure to comply with applicable legal requirements
could lead to enforcement and sanctions by the responsible regulatory authorities, which could have a material adverse effect on our business,
financial condition and results of operations

Our relationships with customers and third-party payors will
be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions,
substantial civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

Although we do not currently have any products
on the market, upon commercialization of our drug candidates, if approved, we will be subject to additional healthcare statutory and regulatory
requirements and oversight by federal and state governments in the United States as well as international governments in the jurisdictions
in which we conduct our business. Physicians, other healthcare providers, and third-party payors will play a primary role in the recommendation
and prescription of any drug candidates for which we obtain marketing approval. Our future arrangements with third-party payors and customers
may expose us to broadly applicable federal and state fraud and abuse and other healthcare laws and regulations that may constrain the
business or financial arrangements and relationships through which we market, sell and distribute any products for which we obtain marketing
approval. Restrictions under applicable healthcare laws and regulations include the following:

The Anti-Kickback Statute prohibits, among other
things, persons from knowingly and willfully soliciting, offering, receiving or providing any remuneration, directly or indirectly, in
cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation
of, any good or service, for which payment may be made under a federal healthcare program such as Medicare and Medicaid;