Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 295

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 295
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 importer can import
them for commercial purposes if it obtains an importer registration and files an application for an import permit for each import. The
DEA provides annual assessments/estimates to the International Narcotics Control Board, which guides the DEA in the amounts of controlled
substances that the DEA authorizes to be imported. The failure to identify an importer or obtain the necessary import authority, including
specific quantities, could affect the availability of our drug candidates. In addition, an application for a Schedule II importer registration
must be published in the Federal Register, and there is a waiting period for third-party comments to be submitted. It is always possible
that adverse comments may delay the grant of an importer registration. If our drug candidates are approved and classified as a Schedule
II controlled substance, federal law may prohibit the import of the substance for commercial purposes. If our drug candidates are listed
as a Schedule II substance, we will not be allowed to import the drug for commercial purposes unless the DEA determines that domestic
supplies are inadequate or there is inadequate domestic competition among domestic manufacturers for the substance as defined by the DEA.
Moreover, Schedule I controlled substances have never been registered with the DEA for importation for commercial purposes, only for scientific
and research needs. Therefore, if neither our drug candidates nor our drug substances could be imported, the drug candidates would have
to be wholly manufactured in the United States, and we would need to secure a manufacturer that would be required to obtain and maintain
a separate DEA registration for that activity. The failure to maintain the necessary registrations or comply with applicable laws could
delay the commercialization of our drug candidates and could delay the completion of the clinical studies.

●Distribution in the United States. If our drug candidates are scheduled as Schedule II, III or IV, we would also need to identify
wholesale distributors with the appropriate DEA registrations and authority to distribute our drug candidates and any future drug candidates.
These distributors would need to obtain Schedule II, III or IV distribution registrations. This limitation in the ability to distribute
our drug candidates more broadly may limit commercial uptake and could negatively impact our prospects. The failure to obtain, or delay
in obtaining, or the loss of any of those registrations could result in increased costs. If our drug candidates are a Schedule II drug,
participants in our supply chain may have to maintain enhanced security with alarms and monitoring systems and they may be required to
adhere to recordkeeping and inventory requirements. This may discourage some pharmacies from carrying the product. In addition, our drug