Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2663

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2663
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states and parallel distribution, or arbitrage between low-priced and high-priced member states, can further reduce prices. A member
state may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability
of the company placing the medicinal product on the market. In some countries, we may be required to conduct a clinical trial or other
studies that compare the cost-effectiveness of any of our product candidates to other available therapies in order to obtain or maintain
reimbursement or pricing approval. There can be no assurance that any country that has price controls or reimbursement limitations for
biopharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our products. Historically, products
launched in the EU do not follow price 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