Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2155

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2155
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 companies established outside the EEA that process personal
data in connection with the offering of goods or services to data subjects in the EU or the monitoring of the behavior of data subjects
in the European Union. The GDPR enhances data protection obligations for data controllers of personal data, including stringent requirements
relating to the consent of data subjects, expanded disclosures about how personal data is used, requirements to conduct privacy impact
assessments for “high risk” processing, limitations on retention of personal data, mandatory data breach notification and
“privacy by design” requirements, and creates direct obligations on service providers acting as data processors. The GDPR
also imposes strict rules on the transfer of personal data outside of the EEA to countries that do not ensure an adequate level of protection,
like the United States. Failure to comply with the requirements of the GDPR and the related national data protection laws of the EEA
Member States may result in fines up to 20 million Euros or 4% of a company’s global annual revenues for the preceding financial
year, whichever is higher. Moreover, the GDPR grants data subjects the right to claim material and non-material damages resulting from
infringement of the GDPR. Given the breadth and depth of changes in data protection obligations, maintaining compliance with the GDPR,
will require significant time, resources and expense, and we may be required to put in place additional mechanisms ensuring compliance
with the new data protection rules. This may be onerous and adversely affect our business, financial condition, results of operations
and prospects.

The
Rest of the World Regulation

For
other countries outside of the European Union and the United States, such as countries in Eastern Europe, Latin America or Asia, the
requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country. Additionally,
the clinical trials must be conducted in accordance with GCP requirements and the applicable regulatory requirements and the ethical
principles that have their origin in the Declaration of Helsinki.

If
we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal
of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

Additional
Laws and Regulations Governing International Operations

If
we further expand our operations outside of the United States, we must dedicate additional resources to comply with numerous laws and
regulations in each jurisdiction in which we plan to operate. The Foreign Corrupt Practices Act, or FCPA, prohibits any United States