Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 41

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 41
---
 that could prevent, limit or delay regulatory approval of our
product candidates.

We also cannot predict the likelihood, nature or
extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad.

The FDA and other regulatory agencies actively enforce the laws
and regulations prohibiting the promotion of off-label uses.

If any of our product candidates are approved and
we are found to have improperly promoted off-label uses of those products, we may become subject to significant liability. The FDA and
other regulatory agencies strictly regulate the promotional claims that may be made about prescription products, if approved. In particular,
while the FDA permits the dissemination of truthful and non-misleading information about an approved product, a manufacturer may not promote
a product for uses that are not approved by the FDA or such other regulatory agencies as reflected in the product’s approved labeling.
If we are found to have promoted such off-label uses, we may become subject to significant liability. The federal government has levied
large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined several companies from
engaging in off-label promotion. The government has also required companies to enter into consent decrees, corporate integrity agreements
or imposed permanent injunctions under which specified promotional conduct must be changed or curtailed. If we cannot successfully manage
the promotion of our product candidates, if approved, we could become subject to significant liability, which would materially adversely
affect our business, financial condition and results of operations.

Risks Related to Commercialization

If, in the future, we are unable to establish sales and marketing
capabilities or enter into agreements with third parties to sell and market any product candidates we may develop, we may not be successful
in commercializing those product candidates if and when they are approved.

We do not have a sales or marketing infrastructure
and have little experience in the sale, marketing or distribution of pharmaceutical products. To achieve commercial success for any approved
product for which we retain sales and marketing responsibilities, we must either develop a sales and marketing organization or outsource
these functions to third parties. In the future, we may choose to build a focused sales, marketing and commercial support infrastructure
to market and sell our product candidates, if and when they are approved. We may also elect to enter into collaborations or strategic
partnerships with third parties to engage in commercialization activities with respect to selected product candidates, indications or
geographic territories, including territories outside the United States, although there is no