Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 178

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 178
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 addition, these agreements typically restrict
the ability of our collaborators, advisors, employees and consultants to publish data potentially relating to our trade secrets. Our academic
collaborators typically have rights to publish data, provided that we are notified in advance and may delay publication for a specified
time in order to secure our intellectual property rights arising from the collaboration. In other cases, publication rights are controlled
exclusively by us. In other cases, we may share these rights with other parties. Despite our efforts to protect our trade secrets, our
competitors may discover our trade secrets, either through breach of these agreements, independent development or publication of information
including our trade secrets in cases where we do not have proprietary or otherwise protected rights at the time of publication.

We could be required to incur significant expenses to obtain
our intellectual property rights, and we cannot ensure that we will obtain meaningful patent protection for our drug candidates.

The patent prosecution process is expensive and
time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in
a timely manner. In addition, it is also possible that we will fail to identify patentable aspects of further inventions made in the course
of our research, development or commercialization activities before they are publicly disclosed, making it in many cases too late to obtain
patent protection on them. Further, given the amount of time required for the development, testing and regulatory review of new drug candidates,
patents protecting such candidates might expire before or shortly after such candidates are commercialized. We expect to seek extensions
of patent terms where these are available in any countries where we are prosecuting patents. This includes in the United States under
the Drug Price Competition and Patent Term Restoration Act of 1984, which permits a patent term extension of up to five years beyond the
expiration of a patent that covers an approved product where the permission for the commercial marketing or use of the product is the
first permitted commercial marketing or use, and as long as the remaining term of the patent does not exceed 14 years from the product’s
approval date. However, the applicable authorities, including the FDA in the United States, and any comparable regulatory authority in
other countries, may not agree with our assessment of whether such extensions are available, and may refuse to grant extensions to our
patents, or may grant more limited extensions than we request. If this occurs, our competitors may be able to take advantage of our investment
in development and clinical trials by referencing our