Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3492

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3492
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 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 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