Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2557

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2557
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 a draft assessment report, a draft summary of the
    product characteristics, or SmPC, and a draft of the labeling and package leaflet, which are sent to the other Member States (referred
    to as the Concerned Member States, or CMSs) for their approval. If the CMSs raise no objections, based on a potential serious risk
    to public health, to the assessment, SmPC, labeling, or packaging proposed by the RMS, the product is subsequently granted a national
    MA in all the Member States (i.e., in the RMS and the CMSs).

Under
the above described procedures, before granting the MA, the EMA or the competent authorities of the Member States of the EEA make an
assessment of the risk-benefit balance of 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