Company: CPMV
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001683168-25-002584
Chunk: 7

Company: Mosaic ImmunoEngineering Inc.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 7
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 trade
secrets in the event of unauthorized use or disclosure of such information.

Third-Party Rights

Our success also depends in part on our ability to
gain access to third-party patent and proprietary rights and to operate our business without infringing on third-party patent rights.
We may be required to obtain licenses to patents or other proprietary rights from third parties to develop, manufacture and commercialize
potential product candidates. Licenses required under third-party patents or proprietary rights may not be available on terms acceptable
to us, if at all. If we do not obtain the required licenses, we could encounter delays in product development while we attempt to redesign
products or methods or we could be unable to develop, manufacture or sell products, if approved, requiring these licenses at all. The
failure to obtain licenses, if needed, may have a material adverse effect on our business, operating results, and financial position.

 4 

Government
Regulation

Regulatory Compliance

Pending our ability to raise sufficient capital and
successfully identify new product candidates and license or acquire those rights, the anticipated research and development activities,
including testing in laboratory animals and in humans, manufacture of product candidates, and oversight of suppliers and contract manufacturers
involved in the production of product candidates, as well as the design, manufacturing, safety, efficacy, handling, labeling, storage,
record-keeping, advertising, promotion and marketing of these product candidates that we may develop, are all subject to stringent regulation,
primarily by the FDA in the United States under the Federal Food, Drug, and Cosmetic Act (the “FDCA”) and its implementing regulations,
and the Public Health Service Act (“PHS Act”) and its implementing regulations, and by comparable authorities under similar
laws and regulations in other countries. If for any reason we do not comply with applicable requirements, such noncompliance can result
in various adverse consequences, including one or more delays in approval of, or even the refusal to approve, product licenses or other
applications, the suspension or termination of clinical investigations, the revocation of approvals if granted, as well as fines, criminal
prosecution, recall or seizure of products, injunctions against shipping products and total or partial suspension of production and/or
refusal to allow us to enter into governmental supply contracts.

Product Development and Approval Process

Pending our ability to raise sufficient capital and
successfully identify new product candidates and license or acquire those rights, in the United States, product candidates we may develop
may likely be regulated as biologic pharmaceuticals,