Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2601

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2601
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 competitive products could limit the demand, and the price we are
able to charge, for any products that we may develop and commercialize.

Risks
Related to Manufacturing

Because
we rely on third-party manufacturing and supply vendors, our supply of research and development, preclinical and clinical development
materials may become limited or interrupted or may not be of satisfactory quantity or quality.

We
rely on third-party contract manufacturers to manufacture our product candidates for preclinical studies and clinical trials. We do not
own manufacturing facilities for producing any clinical trial product supplies. There can be no assurance that our preclinical and clinical
development product supplies will not be limited, interrupted, or of satisfactory quality or continue to be available at acceptable prices.
In particular, any replacement of a contract manufacturer could require significant effort and expertise because there may be a limited
number of qualified replacements.

The
manufacturing process for a product candidate is subject to FDA and foreign regulatory authority review. Suppliers and manufacturers
must meet applicable manufacturing requirements and undergo rigorous facility and process validation tests required by regulatory authorities
in order to comply with regulatory standards, such as current Good Manufacturing Practices, or cGMPs. In the event that any of our manufacturers
fails to comply with such requirements or to perform its obligations to us in relation to quality, timing or otherwise, or if our supply
of components or other materials becomes limited or interrupted for other reasons, we may be forced to manufacture the materials ourselves,
for which we currently do not have the capabilities or resources, or enter into an agreement with another third-party, which we may not
be able to do on reasonable terms, if at all. In some cases, the technical skills or technology required to manufacture our product candidates
may be unique or proprietary to the original manufacturer and we may have difficulty transferring such skills or technology to another
third-party and a feasible alternative may not exist. These factors would increase our reliance on such manufacturer or require us to
obtain a license from such manufacturer in order to have another third-party manufacture our product candidates. If we are required to
change manufacturers for any reason, we will be required to verify that the new manufacturer maintains facilities and procedures that
comply with quality standards and with all applicable regulations and guidelines. We will also need to verify, such as through a manufacturing
comparability or bridging study, that any new manufacturing process will produce our product candidate according to the specifications
previously submitted to the FDA or another regulatory authority. The delays associated with the verification of a