Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 152

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 152
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 maintain
a DEA researcher registration that will allow those sites to handle and dispense our drug candidates and to obtain the product from our
importer. If the DEA delays or denies the grant of a researcher registration to one or more research sites, the clinical trial could be
significantly delayed, and we could lose clinical trial sites. The importer for the clinical trials must also obtain a Schedule I importer
registration and an import permit for each import. We do not currently conduct any manufacturing or repackaging/relabeling of any of our
drug candidates or their active ingredients in the United States.

59

●Importation. If our drug candidates are approved and classified as a Schedule II, III or IV substance, an 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