Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2258

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2258
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 structures of the United States and generally prices tend to be significantly lower. Publication
of discounts by third-party payors or authorities may lead to further pressure on the prices or reimbursement levels within the country
of publication and other countries. If pricing is set at unsatisfactory levels or if reimbursement of our products is unavailable or
limited in scope or amount, our revenues from sales and the potential profitability of any of our product candidates in those countries
would be negatively affected.

We
may incur substantial costs in our efforts to comply with evolving global data protection laws and regulations, and any failure or perceived
failure by us to comply with such laws and regulations may harm our business and operations.

119

The
global data protection landscape is rapidly evolving, and we may be or become subject to or affected by numerous federal, state and foreign
laws and regulations, as well as regulatory guidance, governing the collection, use, disclosure, transfer, security and processing of
personal data, such as information that we collect about participants and healthcare providers (including information relating to their
representatives) in connection with clinical trials. Processing of personal data, including health related information, is increasingly
subject to legislation and regulations in numerous jurisdictions around the world, including General Data Protection Regulation, (EU)
2016/679, or GDPR, and each of the California Consumer Privacy Act of 2018, or CCPA, and the Health Insurance Portability and Accountability
Act, or HIPAA, in the United States, among many others. Our regulatory obligations in foreign jurisdictions could harm the use or cost
of our solution in international locations as data protection and privacy laws and regulations around the world continue to evolve. Implementation
standards and enforcement practices are likely to remain uncertain for the foreseeable future, which may create uncertainty in our business,
affect our or our service providers’ ability to operate in certain jurisdictions or to collect, store, transfer use and share personal
data, result in liability or impose additional compliance or other costs on us. Any failure or perceived failure by us to comply with
federal, state, or foreign laws or self-regulatory standards could result in negative publicity, diversion of management time and effort
and proceedings against us by governmental entities or others.

The
CCPA, which went into effect on January 1, 2020, provides new data privacy rights for consumers and new operational requirements for
companies, which may increase our compliance costs and potential liability. The CCPA gives California residents expanded rights to access
and delete their personal information,