Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 145

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 145
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 approving an ANDA or 505(b)(2) NDA when certain marketing or data exclusivity protections apply to
the reference listed drug. However, if any competitor or third party is able to demonstrate bioequivalence without infringing our patents,
then such competitor or third party may then be able to gain approval of an ANDA and introduce a competing generic product onto the market.

Furthermore,
the CREATES Act established a private cause of action that permits a generic product developer to sue the brand manufacturer to compel
it to furnish necessary samples of an RLD on “commercially reasonable, market-based terms.” If generic developers request
samples of any drug candidates for which we receive marketing approval in order to conduct comparative testing to support one or more
ANDAs for a generic version of our products, and we refuse any such request, we may be subject to litigation under the CREATES Act. Although
lawsuits have been filed under the CREATES Act since its enactment, those lawsuits have generally settled privately there continues to
be uncertainty regarding the scope and application of the law.

Settlements and related licensing agreements resulting
from Hatch-Waxman litigation can be challenged and have the potential to generate additional litigation which can be costly. The success
of such litigation depends on the strength of the patents covering our branded products and our ability to prove that the follow-on applicant’s
product would infringe one or more such patents. The outcome of such litigation is inherently uncertain and may result in potential loss
of any market exclusivity we may receive for our drug candidates, if approved, which may have a significant financial impact on our business.
Furthermore, the FTC, has brought successful lawsuits challenging Hatch-Waxman litigation settlements as anti-competitive, and such decisions
have been upheld by federal circuit courts. If we engage in Hatch-Waxman litigation, we may also face an FTC challenge with respect to
any proposed settlement related to such litigation, which may result in additional expense or penalty. The FTC also has more recently
been questioning pharmaceutical company patent listings in the Orange Book and raising concerns about “improper” listings
that may be intended to discourage competition by follow-on drug developers, and certain members of Congress have been investigating similar
issues. Accordingly, there could be future changes to federal laws, regulations, or guidelines related to Hatch-Waxman requirements or
procedures that could have a material adverse impact on all pharmaceutical innovators, including us.

We
cannot predict the interest of potential follow-on competitors or how quickly others may seek to come