Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2130

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2130
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 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 for a different
product. The sponsor of a tropical disease drug product receiving a PRV may transfer (including by sale) the voucher to another
sponsor of an NDA or BLA. The FD&C Act does not limit the number of times a PRV may be transferred before the voucher is
used.

For
a product to qualify for a PRV, (i) the sponsor must request approval of the product for the prevention or treatment of a “tropical
disease” listed in Section 524 of the FD&C Act, (ii) the product must otherwise qualify for priority review, and (iii) the
product must contain no active ingredient (including any salt or ester of an active ingredient) that has been approved by the FDA in
any other NDA or