Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 165

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 165
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 increased regulatory scrutiny of California businesses in the areas of data protection and security. The substantive requirements
for businesses subject to the CPRA went into effect on January 1, 2023 and became enforceable on July 1, 2023.

Patent Term Restoration and Extension

Depending upon the timing, duration and specifics
of FDA approval of product candidates, some U. S. patents may be eligible for limited patent term extension under the Hatch-Waxman Amendments.
The Hatch-Waxman Amendments permit a patent restoration term of up to five years as compensation for patent term lost during product development
and the FDA regulatory review process. However, patent term restoration cannot extend the remaining term of a patent beyond a total of
14 years from the product’s approval date. The patent term restoration period generally is one-half the time between the effective
date of an IND and the submission date of a BLA less any time the sponsor did not act with due diligence during the period, plus the time
between the submission date of a BLA and the approval of that application less any time the sponsor did not act with due diligence during
the period. Only one patent applicable to an approved biologic product is eligible for the extension, only those claims covering the approved
drug, a method for using it, or a method for manufacturing it may be extended, and the application for the extension must be submitted
prior to the expiration of the patent. Moreover, a given patent may only be extended once based on a single product. The USPTO, in consultation
with the FDA, reviews and approves the application for any patent term extension or restoration. Similar provisions are available in Europe
and other foreign jurisdictions to extend the term of a patent that covers an approved drug. In the future, if and when our products receive
FDA approval, we expect to apply for patent term extensions on patents covering those products, however there is no guarantee that the
applicable authorities, including the FDA in the United States, will agree with our assessment of whether such extensions should be granted,
and if granted, the length of such extensions. See “ Item 3. D. Risk Factors - Risks Related to Our Intellectual Property.”

Legal proceedings

We are not currently subject to any material legal
proceedings.

Employees

As of January 21, 2024, our senior management
team is comprised of Adi Zuloff-Shani (Chief Executive Officer), Mark Haden (Vice President of Business Development), and Alan Rootenberg
(Chief