Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2597

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2597
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, a diagnostic company with
whom we contract may decide to discontinue developing, selling or manufacturing the companion diagnostic test that we anticipate using
in connection with development and commercialization of our product candidates or our relationship with such diagnostic company may otherwise
terminate. We may not be able to enter into arrangements with another diagnostic company to obtain supplies of an alternative diagnostic
test for use in connection with the development and commercialization of our product candidates or do so on commercially reasonable terms,
which could adversely affect and/or delay the development or commercialization of our therapeutic product candidates.

84

We
may in the future seek orphan drug designation for our product candidates, but we may be unable to obtain orphan drug designation and,
even if we obtain such designation, we may not be able to realize or maintain the benefits of such designation, including potential marketing
exclusivity of our product candidates, if approved.

Regulatory
authorities in some jurisdictions, including the United States and other major markets, may designate products intended to treat conditions
or diseases affecting relatively small patient populations as orphan drugs. Under the Orphan Drug Act of 1983, the FDA may designate
a drug or biologic product candidate as an orphan drug if it is intended to treat a rare disease or condition, which is generally defined
as having a patient population of fewer than 200,000 individuals in the United States, or a patient population greater than 200,000 in
the United States where there is no reasonable expectation that the cost of developing the product will be recovered from sales in the
United States. Orphan drug designation must be requested before submitting a marketing application. In the United States, orphan drug
designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages
and user-fee waivers. After the FDA grants orphan drug designation, the generic identity of the drug or biologic and its potential orphan
use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory
review and approval process.

Generally,
if a product candidate with an orphan drug designation receives the first marketing approval for the indication for which it has such
designation, the product is entitled to a period of marketing exclusivity, which precludes the FDA or foreign regulatory authorities
from approving another marketing application for a product that constitutes the same drug treating the same indication for a period of
seven (7) years, except in limited circumstances, such as a showing of clinical superiority to