Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 91

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 91
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 date of approval of the ANDA or 505(b)(2) application.

If the follow-on applicant has provided a Paragraph
IV certification to the FDA, the applicant must also send notice of the Paragraph IV certification to the NDA and patent holders once
the follow-on application in question has been accepted for filing by the FDA. The NDA and patent holders may then initiate a patent infringement
lawsuit in response to the notice of the Paragraph IV certification. The filing of a patent infringement lawsuit within 45 days after
the receipt of a Paragraph IV certification automatically prevents the FDA from approving the ANDA or 505(b)(2) NDA until the earlier
of 30 months after the receipt of the Paragraph IV notice, expiration of the patent, or a decision in the infringement case that is favorable
to the ANDA or 505(b)(2) applicant. Alternatively, if the listed patent holder does not file a patent infringement lawsuit within the
required 45-day period, the follow-on applicant’s ANDA or 505(b)(2) NDA will not be subject to the 30-month stay.

Other U.S. Healthcare Laws and Regulations

If our drug candidates are approved in the United
States, we will have to comply with various U.S. federal and state laws, rules and regulations pertaining to healthcare fraud and abuse,
including anti-kickback laws and physician self-referral laws, rules and regulations. Violations of the fraud and abuse laws are punishable
by criminal and civil sanctions, including, in some instances, exclusion from participation in federal and state healthcare programs,
including Medicare and Medicaid. These laws include:

●The federal Anti-Kickback Statute (the “AKS”) prohibits, among other things, persons from knowingly and willfully soliciting,
offering, receiving or paying remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an
individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole or in part,
under a federal healthcare program such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the AKS
or specific intent to violate it to have committed a violation. In addition, the government may assert that a claim including items or
services resulting from a violation of the AKS constitutes a false or fraudulent claim for purposes of the FCA or federal civil money
penalties statute;

25

●The federal civil and