Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3555

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3555
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 environmental damage resulting in costly clean-up and liabilities
under applicable laws and regulations governing the use, storage, handling, and disposal of these materials and specified waste products.
Although we believe that the safety procedures utilized by us and our third-party manufacturers for handling and disposing of these materials
generally comply with the standards prescribed by these laws and regulations, we cannot guarantee that this is the case or eliminate
the risk of accidental contamination or injury from these materials. In such an event, we may be held liable for any resulting damages
and such liability could exceed our resources, and state or federal or other applicable authorities may curtail our use of specified
materials and/or interrupt our business operations. Furthermore, environmental laws and regulations are complex, change frequently, and
have tended to become more stringent. We cannot predict the impact of such changes and cannot be certain of our future compliance. We
do not currently carry biological or hazardous waste insurance coverage.

Compliance
with governmental regulations regarding the treatment of animals used in research could increase our operating costs, which would adversely
affect the commercialization of our products.

The
Animal Welfare Act, or AWA, is the federal law that covers the treatment of certain animals used in research. Currently, the AWA imposes
a wide variety of specific regulations that govern the humane handling, care, treatment and transportation of certain animals by producers
and users of research animals, most notably relating to personnel, facilities, sanitation, cage size, and feeding, watering and shipping
conditions. Third parties with whom we contract are subject to registration, inspections and reporting requirements under the AWA. Furthermore,
some states have their own regulations, including general anti-cruelty legislation, which establish certain standards in handling animals.
Comparable 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,