Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2193

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2193
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 our product candidates, if approved.

Even
if we obtain orphan drug exclusivity for a product candidate, that exclusivity may not effectively protect the product candidate from
competition because different drugs can be approved for the same condition in the United States. Even after an orphan drug is approved,
the FDA may subsequently approve another drug for the same condition if the FDA concludes that the latter drug is not the same drug or
is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care.

If
product liability lawsuits are brought against us, we may incur substantial financial or other liabilities and may be required to limit
commercialization of our product candidates.

We
will face an inherent risk of product liability as a result of testing any of our other product candidates in clinical trials, and will
face an even greater risk if we commercialize any products. For example, we may be sued if our product candidates cause or are perceived
to cause injury or are found to be otherwise unsuitable during clinical trials, manufacturing, marketing or sale. Any such product liability
claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product,
negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot
successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization
of our product candidates. Even successful defense would require significant financial and management resources. Regardless of the merits
or eventual outcome, liability claims may result in:

    ●
    inability
    to bring a product candidate to the market;

    ●
    decreased
    demand for our products;

85

    ●
    injury
    to our reputation;

    ●
    withdrawal
    of clinical trial participants and inability to continue clinical trials;

    ●
    initiation
    of investigations by regulators;

    ●
    fines,
    injunctions or criminal penalties;

    ●
    costs
    to defend the related litigation;

    ●
    diversion
    of management’s time and our resources;

    ●
    substantial
    monetary awards to trial participants;

    ●
    product
    recalls, withdrawals or labeling, marketing or promotional restrictions;

    ●
    loss
    of revenue;

    ●
    exhaustion
    of any available insurance and our capital resources;

    ●
    the
    inability to commercialize any product candidate, if approved; and