Company: CPMV
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001683168-25-002584
Chunk: 30

Company: Mosaic ImmunoEngineering Inc.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 30
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 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 supplies of products. Additionally, macro-economic conditions
may adversely affect these third parties, causing them to suffer liquidity or operational problems. If a key third-party vendor becomes
insolvent or is forced to lay off workers assisting with our projects, our results and development timing could suffer.

In addition, any products that we may develop may
compete with other product candidates and products for access to manufacturing facilities. There are a limited number of manufacturers
that operate under cGMP regulations that may be capable of manufacturing for us. Our anticipated future dependence upon others for the
manufacture of product candidates or products may adversely affect our future profit margins and our ability to commercialize any products
that receive marketing approval on a timely and competitive basis.

Data provided by collaborators and other parties
upon which we rely has not been independently verified and could turn out to be inaccurate, misleading, or incomplete.

If we are able to raise sufficient capital and potentially
license or acquire new technologies, then we would intend to rely on third-party vendors, scientists, and collaborators to provide us
with significant data and other information related to our projects, clinical trials, and business. In addition, we would likely not independently
verify