Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 161

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 161
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 does not exist on the U. S. Toxic Substances Control Act Chemical
Substance Inventory List.

In Canada, Health Canada has stated that MEAI is
a controlled substance due to its structure being similar to amphetamines, which are on Health Canada’s Controlled Substances List.
However, at this point in time, the molecule MEAI itself is not listed in Schedule I of Health Canada’s Controlled Substances List,
which includes: amphetamines, their salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues.

In Israel, the Israeli Ministry of Health has stated
that 2 - Aminoindane, including derivatives and isomers, is a controlled substance. Since, MEAI is a derivative of 2 - Aminoindane,
it is considered a controlled substance.

Food products containing MEAI may be determined
to be illegal. For example, one Canadian food product containing MEAI was determined to be illegal in Canada. However, to the best of
our knowledge, this specific product sold in Canada was not manufactured under cGMP conditions and may have contained other substances
as well. In addition, to the best of our knowledge, no regulatory process took place and no regulatory dossier was submitted in Canada
or any other jurisdiction, in that matter, to ask for approval for commercialization of that product.

Other Healthcare Laws

Pharmaceutical companies are subject to additional
healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which they
conduct their business. Such laws include, without limitation, state and federal anti-kickback, fraud and abuse, false claims, data privacy
and security and physician sunshine laws and regulations. If their operations are found to be in violation of any of such laws or any
other governmental regulations that apply, they may be subject to penalties, including, without limitation, civil and criminal penalties,
damages, fines, the curtailment or restructuring of operations, exclusion from participation in federal and state healthcare programs
and individual imprisonment.

Coverage and Reimbursement

Sales of any product depend, in part, on the extent
to which such product will be covered by third-party payors, such as federal, state, and foreign government healthcare programs, commercial
insurance and managed healthcare organizations, and the level of reimbursement for such product by third-party payors. Decisions regarding
the extent of coverage and amount of reimbursement to be provided are made on a plan-by-plan basis. These third-party pay