Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 64

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 64
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 Business Overview - Strategic Focus - Phase
I/IIa Clinical Study.” We rely, and expect to continue to rely, on third-party manufacturers to produce our product candidates or
other product candidates that we may identify for clinical trials, as well as for commercial manufacture if any product candidates receive
marketing authorization and approval. Although we generally do not begin a clinical trial unless we believe they have a sufficient supply
of a product candidate to complete the trial, any significant delay or discontinuity in the supply of a product candidate, or the raw
material components thereof, for an ongoing clinical trial due to the need to replace a third-party manufacturer could considerably delay
the clinical development and potential regulatory authorization of our product candidates, which could harm our business and results of
operations.

We may be unable to identify and appropriately
qualify third-party manufacturers or establish agreements with third-party manufacturers or do so on acceptable terms. Even if they are
able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

  reliance on the third party for sourcing of raw materials, components, and such other goods as may be required for execution of its manufacturing processes and the oversight by the third party ...  
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  reliance on the third party for regulatory compliance and quality assurance for the manufacturing activities each performs;  

  the possible breach of the manufacturing agreement by the third party;  

  the possible misappropriation of proprietary information, including trade secrets and know-how; and  

  the possible termination or non-renewal of the agreement by the third party at a time that is costly or inconvenient for us.  

Furthermore, we and our CMOs are engaged with other
companies to supply and/or manufacture materials or products for such companies, which exposes our manufacturers to regulatory risks for
the production of such materials and products. The facilities used by our contract manufacturers to manufacture their drug or medical
device product candidates are subject to review by the FDA pursuant to inspections that will be conducted after we submit an NDA, a biologics
license application, or BLA, premarket approval application, or PMA, or other marketing application to the FDA. We do not control the
manufacturing process of, and are to some extent dependent on, our contract manufacturing partners for compliance with the regulatory
requirements, known as cGMP requirements for manufacture of drug and device products. If