Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2535

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2535
---
 and for which there is no reasonable expectation that the cost of developing and making the product available in
the United States for this type of disease or condition will be recovered from sales of the product.

Orphan
drug designation must be requested before submitting an NDA or BLA. After the FDA grants orphan drug designation, the identity of the
therapeutic agent 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.

If
a product that has orphan drug designation subsequently receives the first FDA approval for the disease or condition for which it has
such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications
to market the same drug for the same indication for seven years from the date of such approval, except in limited circumstances, such
as a showing of clinical superiority to the product with orphan exclusivity by means of greater effectiveness, greater safety or providing
a major contribution to patient care or in instances of drug supply issues. Competitors, however, may receive approval of either a different
product for the same indication or the same product for a different indication but that could be used off-label in the orphan indication.
Orphan drug exclusivity also could block the approval of one of our products for seven years if a competitor obtains approval before
we do for the same product, as defined by the FDA, for the same indication we are seeking approval, or if our product is determined to
be contained within the scope of the competitor’s product for the same indication or disease. If we pursue marketing approval for
an indication broader than the orphan drug designation we have received, we may not be entitled to orphan drug exclusivity. Orphan drug
status in the European Union has similar, but not identical, requirements and benefits.

51

Tropical
Disease Priority Review Voucher Program

The
FDA has authority to award priority review vouchers, or PRVs, to sponsors of certain tropical disease product applications. The
FDA’s Tropical Disease Priority Review Voucher Program is designed to encourage development of new drug and biological
products for the prevention and treatment of certain tropical diseases affecting millions of people throughout the world. Under this
program, a sponsor who receives an approval for a drug or biologic for the prevention or treatment of a tropical disease that meets
certain criteria may qualify for a PRV that can be redeemed to receive priority review of a subsequent NDA or BLA