Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2661

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2661
---
 rules, regulations, and or obligations exist in many foreign jurisdictions. If we or our contractors fail to comply with regulations
concerning the treatment of animals used in research, we may be subject to fines and penalties and adverse publicity, and our operations
could be adversely affected.

Risks
Related to Government Regulations Internationally

Even
if we obtain FDA approval of any of our product candidates, we may never obtain approval or commercialize such products outside of the
United States, which would limit our ability to realize their full market potential.

In
order to market any products outside of the United States, we must establish and comply with numerous and varying regulatory requirements
of other countries regarding safety and efficacy. Clinical trials conducted in one country may not be accepted by regulatory authorities
in other countries, and regulatory approval in one country does not mean that regulatory approval will be obtained in any other country.
Approval procedures vary among countries and can involve additional product testing and validation and additional administrative review
periods. Seeking foreign regulatory approvals could result in significant delays, difficulties and costs for us and may require additional
preclinical studies or clinical trials which would be costly and time consuming. Regulatory requirements can vary widely from country
to country and could delay or prevent the introduction of our products in those countries. Satisfying these and other regulatory requirements
is costly, time consuming, uncertain and subject to unanticipated delays. In addition, our failure to obtain regulatory approval in any
country may delay or have negative effects on the process for regulatory approval in other countries. We do not have any product candidates
approved for sale in any jurisdiction, including international markets, and we do not have experience in obtaining regulatory approval
in international markets. If we fail to comply with regulatory requirements in international markets or to obtain and maintain required
approvals, our ability to realize the full market potential of our products will be harmed.

118

EU
drug marketing and reimbursement regulations may materially affect our ability to market and receive coverage for our products in the
European member states.

We
intend to seek approval to market our product candidates in both the United States and in selected foreign jurisdictions. If we obtain
approval in one or more foreign jurisdictions for our product candidates, we will be subject to rules and regulations in those jurisdictions.
In some foreign countries, particularly those in the EU, the pricing of drugs is subject to governmental control and other market regulations
which could put pressure on the pricing and usage of our product candidates. In these countries, pricing negotiations with governmental
authorities can