Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2602

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2602
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 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 development;

87

    ●
    delay
    in submitting regulatory applications, or receiving regulatory approvals, for product candidates;

    ●
    loss
    of the cooperation of an existing or future collaborator;

    ●
    subjecting
    third-party manufacturing facilities or our manufacturing facilities to additional inspections by regulatory authorities;

    ●
    requirements
    to cease distribution or to recall batches of our product candidates; and

    ●
    in
    the event of approval to market and commercialize a product candidate, an inability to meet commercial demands for our products.

Changes
in methods of product candidate manufacturing or formulation may result in additional costs or delay.

As
product candidates progress through preclinical to late stage clinical trials to marketing approval and commercialization, it is common
that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort
to optimize yield, manufacturing batch size, minimize costs and achieve consistent quality and results. Such changes carry the risk that
they will not achieve these intended objectives. Any of these changes could cause our product candidates to perform differently and affect
the results of planned clinical trials or other future clinical trials conducted with the altered materials. This could delay completion
of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials, increase clinical
trial costs, delay approval of our product candidates and jeopardize our ability to commercialize our product candidates and generate
revenue.

In
addition, there are risks associated with large scale manufacturing for clinical trials or commercial scale including, among others,
cost overruns, potential problems with process scale-up, process reproducibility, stability issues, compliance with good manufacturing
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