Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2598

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2598
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 the product with orphan drug exclusivity
or where the manufacturer is unable to assure sufficient product quantity. Orphan drug exclusivity may be revoked if any regulatory agency
determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of
the product to meet the needs of patients with the rare disease or condition.

We
may seek orphan drug designation for OCF-203 for IPF and HPS, and some of our other future product candidates in additional orphan indications
in which there is a medically plausible basis for the use of these products. We may be unable to obtain and maintain orphan drug designation
and, even if we obtain such designation, we may not be able to realize the benefits of such designation, including potential marketing
exclusivity of 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;

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