Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2554

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2554
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 environmental, health and safety laws and regulations.
Current or future environmental laws and regulations may impair our research, development or production efforts. In addition, failure
to comply with these laws and regulations may result in substantial fines, penalties or other sanctions.

European
Drug Development

In
the European Union, our future products also may be subject to extensive regulatory requirements. As in the United States, medicinal
products can be marketed only if a marketing authorization from the competent regulatory agencies has been obtained.

Similar
to the United States, the various phases of preclinical and clinical research in the European Union are subject to significant regulatory
controls. Although the EU Clinical Trials Directive 2001/20/EC has sought to harmonize the EU clinical trials regulatory framework, setting
out common rules for the control and 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