Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2152

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2152
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 the product on the basis of scientific criteria concerning its quality, safety and efficacy.

Now
that the UK (which comprises Great Britain and Northern Ireland) has left the EU, Great Britain will no longer be covered by centralized
MAs (under the Northern Irish Protocol, centralized MAs will continue to be recognized in Northern Ireland). All medicinal products with
a current centralized MA were automatically converted to Great Britain MAs on January 1, 2021. For a period of two years from January
1, 2021, the Medicines and Healthcare products Regulatory Agency, or MHRA, the UK medicines regulator, may rely on a decision taken by
the European Commission on the approval of a new marketing authorization in the centralized procedure, in order to more quickly grant
a new Great Britain MA. A separate application will, however, still be required.

European
Data and Marketing Exclusivity

In
the EEA, innovative medicinal products qualify for eight years of data exclusivity upon marketing authorization and an additional two
years of market exclusivity. The data exclusivity, if granted, prevents generic or biosimilar applicants from referencing the innovator’s
pre-clinical and clinical trial data contained in the dossier of the reference product when applying for a generic or biosimilar marketing
authorization, for a period of eight years from the date on which the reference product was first authorized in the EEA. During the additional
two-year period of market exclusivity, a generic or biosimilar marketing authorization can be submitted, and the innovator’s data
may be referenced, but no generic or biosimilar product can be marketed until the expiration of the market exclusivity period. The overall
ten-year period will be extended to a maximum of 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