Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2558

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2558
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11 years if, during the first eight years of those ten years, the marketing authorization
holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization,
are determined to bring a significant clinical benefit in comparison with currently approved therapies. Even if an innovative medicinal
product gains the prescribed period of data exclusivity, another company may market another version of the product if such company obtained
a marketing authorization based on an application with a complete and independent data package of pharmaceutical tests, preclinical tests
and clinical trials.

62

European
Orphan Designation and Exclusivity

In
the EEA, the EMA’s Committee for Orphan Medicinal Products grants orphan drug designation to promote the development of products
that are intended for the diagnosis, prevention 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