Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 294

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 294
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 which must renew every three years. The DEA conducts periodic inspections of certain registered establishments
that handle controlled substances. We will need to identify wholesale distributors with the appropriate DEA registrations and authority
to distribute the products to pharmacies and other healthcare providers, and these distributors would need to obtain Schedule II or III
distribution registrations. Obtaining and maintaining the necessary registrations may result in delay of the importation, manufacturing
or distribution of our drug candidates. If we fail to obtain or maintain the necessary registrations, the DEA may seek civil penalties,
refuse to renew necessary registrations or initiate proceedings to restrict, suspend or revoke those registrations. In certain circumstances,
violations could lead to criminal proceedings.

●State-Controlled Substance Laws. Individual states have also established controlled substance laws and regulations. We, our
third-party manufacturers, our distributors or our other partners must obtain applicable DEA and state registrations, permits or licenses,
as applicable, in order to be able to obtain, manufacture, process, handle, distribute, import or export controlled substances for clinical
trials or commercial sale. While some states automatically schedule a drug based on federal action, other states schedule drugs through
rulemaking or a legislative action. State scheduling may delay commercial sale of any product for which we obtain FDA approval, and adverse
scheduling could have a material adverse effect on the commercial sales of such product. Failure to meet applicable regulatory requirements
could lead to enforcement and sanctions by the states in addition to those from the DEA or otherwise arising under federal law, which
could have a material adverse effect on our business, financial condition and results of operations.

●Clinical trials. To conduct clinical trials with any of our investigational drug candidates that fall into categories of substances
that are “controlled substances,” each of our research sites must submit a research protocol to the DEA and obtain and 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.

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