Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3496

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3496
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 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 new manufacturer could
negatively affect our ability to develop product candidates in a timely manner or within budget.

To
the extent that we enter into future manufacturing arrangements with third parties, we will depend on these third parties to perform
their obligations in a timely manner consistent with contractual and regulatory requirements, including those related to quality control
and assurance. If we are unable to obtain or maintain third-party manufacturing for product candidates, or to do so on commercially reasonable
terms, we may not be able to develop and commercialize our product candidates successfully. Our or a third-party’s failure to execute
on our manufacturing requirements and comply with cGMP could adversely affect our business in a number of ways, including:

    ●
    an
    inability to initiate or continue clinical trials of product candidates under