Company: CPMV
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001683168-25-002584
Chunk: 130

Company: Mosaic ImmunoEngineering Inc.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 130
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 or impair our development or commercialization efforts. 

If we are able to raise sufficient capital and potentially
license or acquire new technologies, then due to our limited operations and no existing manufacturing infrastructure or capabilities,
we may utilize third parties to formulate, manufacture, package, and distribute preclinical and clinical supplies. In addition, these
materials are generally custom-made and available from only a limited number of sources. Despite drug substance and product risk management,
this reliance on third parties presents a risk that we will not have sufficient quantities of these product candidates or products or
such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts. Any
performance failure on the part of our future manufacturers of drug substance or drug products could delay clinical development or potential
marketing approval.

 17 

We would also expect to rely on other third parties
to label, store, and distribute drug supplies for our clinical trials. Any performance failure on the part of our distributors could delay
clinical development or marketing approval of product candidates or commercialization of products, producing additional losses and depriving
us of potential product revenue.

If we are able to license or acquire new technologies,
we may be unable to establish any agreements with third-party manufacturers or to do so on acceptable terms. Even if we can establish
agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

    ·
    reliance on the third party for regulatory compliance and quality assurance;

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

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

    ·
    the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.

The third parties we may rely on for manufacturing
and packaging are also subject to regulatory review, and any regulatory compliance problems with these third parties could significantly
delay or disrupt our clinical or commercialization activities. Third-party manufacturers may not be able to comply with cGMP regulations
or similar regulatory requirements outside the United States. Our failure, or the failure of our third-party manufacturers, to comply
with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties,
delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or products, operating restrictions
and criminal prosecutions, any of which could significantly and adversely affect