Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 87

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 87
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 the proposed rescheduling and supporting data and, once completed, will issue a recommendation to the DEA. However, it is uncertain
whether DEA will issue a final rule to implement the rescheduling of either substance. Even if a final rule is issued in either case,
it will likely be subject to continued political opposition or possible legal challenges in federal court.

We will be subject to DEA approval to conduct our clinical trials and
manufacturing activities in the United States. All parties engaged for our projects, including but not limited to formulation development,
manufacturing, preclinical and clinical research, involving controlled substances in the United States must have the appropriate registrations
with and permits from the DEA as well as licenses from applicable state authorities. We may also decide to develop, manufacture or commercialize
our drug candidates in additional countries. As a result, we will be subject to controlled substance laws and regulations from the Australian
Therapeutic Goods Administration (“TGA”), Health Canada’s Office of Controlled Substances, the Drugs & Firearms
Unit (Home Office) of the National Drug Control System in the United Kingdom, and from other regulatory agencies in other countries where
we develop, manufacture or commercialize, if approved, each drug asset in the future.

Patent Term Restoration

Depending upon the timing, duration and specifics
of FDA approval of our drug candidates, some of our United States patents may be eligible for limited patent term extension under the
Drug Price Competition and Patent Term Restoration Act, informally known as the Hatch-Waxman Act. The Hatch-Waxman Act permits a patent
restoration term of up to five years as compensation for patent term lost during product development and the FDA regulatory review process.
However, patent term restoration cannot extend the remaining term of a patent beyond a total of 14 years from the drug candidate’s
approval date. The patent term restoration period is generally one half of the time between the effective date of an IND and the submission
date of an NDA, plus the time between the submission date of the NDA and the approval of that application, except that the review period
is reduced by any time during which the applicant failed to exercise due diligence. Only one patent applicable to an approved drug candidate
is eligible for the extension and the application for extension must be made prior to expiration of the patent. The USPTO, in consultation
with the FDA, reviews and approves the application for any patent term extension or restoration. In the future, we intend to apply for
restorations of patent term for some of