Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 156

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 156
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 adjust aggregate production quotas a few times per
year, and individual manufacturing or procurement quotas from time to time during the year, although the DEA has substantial discretion
in whether or not to make such adjustments for individual companies.

The states also maintain separate controlled substance
laws and regulations, including licensing, recordkeeping, security, distribution, and dispensing requirements. State Authorities, including
Boards of Pharmacy, regulate use of controlled substances in each state. Failure to maintain compliance with applicable requirements,
particularly as manifested in the loss or diversion of controlled substances, can result in enforcement action that could have a material
adverse effect on our business, operations and financial condition. The DEA may seek civil penalties, refuse to renew necessary registrations,
or initiate proceedings to revoke those registrations. In certain circumstances, violations could lead to criminal prosecution.

European Government Regulation

Our product candidates will be subject to similar
laws and regulations imposed by jurisdictions outside of the United States, and, in particular, Europe, which may include, for instance,
applicable post-marketing requirements, including safety surveillance, anti-fraud and abuse laws and implementation of corporate compliance
programs and reporting of payments or other transfers of value to healthcare professionals.

In order to market our future product candidates
in the EEA (which is comprised of the 28 Member States of the European Union plus Norway, Iceland and Liechtenstein) and many other foreign
jurisdictions, we must obtain separate regulatory approvals. More concretely, in the EEA, medicinal product candidates can only be commercialized
after obtaining a Marketing Authorization, or MA. There are two types of marketing authorizations:

  the “ Community MA,” which is issued by the European Commission through the Centralized Procedure, based on the opinion of the Committee for Medicinal Product candidates for Human Use of the EM...  

  “ National MAs,” which are issued by the competent authorities of the Member States of the EEA and only cover their respective territory, are available for product candidates not falling within...  

Under the above-described procedures, before granting
the MA, the EMA or the competent authorities of the Member States of the EEA make an assessment of the risk-benefit balance of the product
on the basis of scientific criteria concerning its quality, safety and efficacy.

Data and marketing exclusivity. In the EEA,
new product candidates authorized for marketing, or reference product candidates, qualify for eight years of data exclusivity and an additional
two years of market exclusivity upon marketing authorization. The data exclusivity period prevents