Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2149

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2149
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 authorization of clinical trials in the European Union, the EU Member States have transposed and
applied the provisions of the Directive differently. This has led to significant variations in the Member State regimes. Under the current
regime, before a clinical trial can be initiated it must be approved in each of the EU countries where the trial is to be conducted by
two distinct bodies: the National Competent Authority, or NCA, and one or more Ethics Committees, or ECs. Under the current regime all
suspected unexpected serious adverse reactions to the investigated drug that occur during the clinical trial have to be reported to the
NCA and ECs of the Member State where they occurred.

The
EU clinical trials legislation currently is undergoing a transition process mainly aimed at harmonizing and streamlining clinical-trial
authorization, simplifying adverse-event reporting procedures, improving the supervision of clinical trials and increasing their transparency.
In April 2014, the EU adopted a new Clinical Trials Regulation (EU) No 536/2014 (the “Regulation”), which is set to replace
the current Clinical Trials Directive 2001/20/EC. The European Commission confirmed January 31, 2022 as the date of entry into application
of the Regulation and the go-live of the Clinical Trials Information System (“CTIS”) by publishing a notice in the Official
Journal of the European Union on July 31, 2021. The new Regulation will be directly applicable in all Member States (and so does not
require national implementing legislation in each Member State), and aims at simplifying and streamlining the approval of clinical studies
in the EU, for instance by providing for a streamlined application procedure via a single point and strictly defined deadlines for the
assessment of clinical trial applications.

European
Drug Marketing

Much
like the Anti-Kickback Statue prohibition in the United States, the provision of benefits or advantages to physicians to induce or encourage
the prescription, recommendation, endorsement, purchase, supply, order or use of medicinal products is also prohibited in the European
Union. The provision of benefits or advantages to induce or reward improper performance generally is usually governed by the national
anti-bribery laws of European Union Member States, and the Bribery Act 2010 in the UK. Infringement of these laws could result in substantial
fines and imprisonment. EU Directive 2001/83/EC, which is the EU Directive governing medicinal products for human use, further provides
that, where medicinal products are being promoted to