Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2667

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2667
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,000 Euros
or up to 4% of our total worldwide annual turnover, whichever is greater, for more serious offenses. The GDPR also confers a private
right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies,
and obtain compensation for damages resulting from violations of the GDPR. The GDPR also introduces the right for non-profit organizations
to bring claims on behalf of data subjects.

Further,
national laws of member states of the EU are in the process of being adapted to the requirements under the GDPR, thereby implementing
national laws which may partially deviate from the GDPR and impose different obligations from country to country, so that we do not expect
to operate in a uniform legal landscape in the EEA. Also, as it relates to processing and transfer of genetic data, the GDPR specifically
allows national laws to impose additional and more specific requirements or restrictions, and European laws have historically differed
quite substantially in this field, leading to additional uncertainty. The United Kingdom’s decision to leave the EU, often referred
to as Brexit, has created uncertainty with regard to data protection regulation in the United Kingdom. In particular, it is unclear how
data transfers to and from the United Kingdom will be regulated now that the United Kingdom has left the EU.

In
the event we commence clinical trials in the EEA, the GDPR may increase our responsibility and liability in relation to personal data
that we process where such processing is subject to the GDPR, and we may be required to put in place additional mechanisms and safeguards
to ensure compliance with the GDPR, including as implemented by individual countries. Compliance with the GDPR will be a rigorous and
time-intensive process that may increase our cost of doing business or require us to change our business practices, and despite those
efforts, there is a risk that we may be subject to fines and penalties, litigation, and reputational harm in connection with our European
activities, as well as materially and adversely affecting our operations and business performance. We expect that we will continue to
face uncertainty as to whether our efforts to comply with any obligations under European privacy laws will be sufficient. If we are investigated
by a European data protection authority, we may face fines and other penalties. Any such investigation or charges by European data protection
authorities could have a negative effect on our existing business and on our ability to attract and retain new clients or biopharmaceutical
partners. We may also experience hesitancy, reluctance, or refusal by European or multi-national clients or bi