Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2560

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2560
---
 of product candidates
in the UK, as UK legislation now has the potential to diverge from EU legislation. It remains to be seen how Brexit will impact regulatory
requirements for product candidates and products in the UK in the long-term. The MHRA, the UK medicines and medical devices regulator,
has recently published detailed guidance for industry and organizations to follow from January 1, 2021 now the transition period is over,
which will be updated as the UK’s regulatory position on medicinal products evolves over time.

63

European
Data Collection

The
collection and use of personal health data in the European Economic Area, or the EEA, is governed by the GDPR, which became effective
May 25, 2018. The GDPR applies to any company established in the EEA and to 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