Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3453

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3453
---
 or treatment of life-threatening or chronically debilitating conditions which either
affect not more than 5 in 10,000 persons in the European Union, or where it is unlikely that the marketing of the medicine would generate
sufficient return to justify the necessary investment in its development. In each case, no satisfactory method of diagnosis, prevention
or treatment must have been authorized (or, if such a method exists, the product in question would be of significant benefit to those
affected by the condition).

In
the EEA, orphan drug designation entitles a party to financial incentives such as reduction of fees or fee waivers and ten years of market
exclusivity is granted following marketing approval for the orphan product. This period may be reduced to six years if the orphan drug
designation criteria are no longer met, including where it is shown that the product is sufficiently profitable not to justify maintenance
of market exclusivity. During the period of market exclusivity, marketing authorization may only be granted to a “similar medicinal
product” for the same therapeutic indication if: (i) a second applicant can establish that its product, although similar to the
authorized product, is safer, more effective or otherwise clinically superior; (ii) the marketing authorization holder for the authorized
product consents to a second orphan medicinal product application; or (iii) the marketing authorization holder for the authorized product
cannot supply enough orphan medicinal product. A “similar medicinal product” is defined as a medicinal product containing
a similar active substance or substances as contained in an authorized orphan medicinal product, and which is intended for the same therapeutic
indication. Orphan drug designation must be requested before submitting an application for marketing approval. Orphan drug designation
does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.

European
Pediatric Investigation Plan

In
the EEA, companies developing a new medicinal product must agree upon a pediatric investigation plan, or PIP, with the EMA’s Pediatric
Committee, or PDCO, and must conduct pediatric clinical trials in accordance with that PIP, unless a waiver applies. The PIP sets out
the timing and measures proposed to generate data to support a pediatric indication of the drug for which marketing authorization is
being sought. The PDCO can grant a deferral of the obligation to implement some or all of the measures of the PIP until there are sufficient
data to demonstrate the efficacy and safety of the product in adults. Further, the obligation to provide pediatric clinical