Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2659

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2659
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 addition, government funding of the SEC and other government agencies on which our operations may rely,
including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

Disruptions
at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies,
which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several times,
and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical employees and stop critical activities. If
a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory
submissions, which could have a material adverse effect on our business. Further, future government shutdowns could impact our ability
to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

We
are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations.
We can face serious consequences for violations.

117

Among
other matters, U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations,
which are collectively referred to as Trade Laws, prohibit companies and their employees, agents, clinical research organizations, legal
counsel, accountants, consultants, contractors, and other partners from authorizing, promising, offering, providing, soliciting, or receiving
directly or indirectly, corrupt or improper payments or anything else of value to or from recipients in the public or private sector.
Violations of Trade Laws can result in substantial criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment,
tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences. We have direct or indirect interactions
with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations. We also
expect our non-U.S. activities to increase in time. We plan to engage third parties for clinical trials and/or to obtain necessary permits,
licenses, patent registrations, and other regulatory approvals and we can be held liable for the corrupt or other illegal activities
of our personnel, agents, or partners, even if we do not explicitly authorize or have prior knowledge of such activities.

If
we fail to comply with environmental, health and safety laws and regulations, we could become subject to