Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2262

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2262
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 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 biopharmaceutical partners
to continue to use our products and solutions due to the potential risk exposure as a result of the current (and, in particular, future)
data protection obligations imposed on them by certain data protection authorities in interpretation of current law, including the GDPR.
Such clients or biopharmaceutical partners may also view any alternative approaches to compliance as being too costly, too burdensome,
too legally uncertain, or otherwise objectionable and therefore decide not to do business with us. Any of the forgoing could materially
harm our business, prospects, financial condition and results of operations.

Additional
laws and regulations governing international operations could negatively impact or restrict our operations.

121

If
we expand our operations outside of the United States, we must dedicate additional resources to comply with numerous laws and