Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2148

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2148
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 the interpretation of existing regulations could impact our business in the future by requiring, for example:
(i) changes to our manufacturing and distribution arrangements; (ii) additions or modifications to product labeling; (iii) the recall
or discontinuation of our products; or (iv) additional record-keeping requirements. If any such changes were to be imposed, they could
adversely affect the operation of our business.

Other
United States Environmental, Health and Safety Laws and Regulations

We
may be subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and
the handling, use, storage, treatment and disposal of hazardous materials and wastes. From time to time and in the future, our operations
may involve the use of hazardous and flammable materials, including chemicals and biological materials, and may also produce hazardous
waste products. Even if we contract with third parties for the disposal of these materials and waste products, we cannot completely eliminate
the risk of contamination or injury resulting from these materials. In the event of contamination or injury resulting from the use or
disposal of our hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources.
We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and
regulations.

We
maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees, but
this insurance may not provide adequate coverage against potential liabilities. However, we do not maintain insurance for environmental
liability or toxic tort claims that may be asserted against us.

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In
addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations.
Current or future environmental laws and regulations may impair our research, development or production efforts. In addition, failure
to comply with these laws and regulations may result in substantial fines, penalties or other sanctions.

European
Drug Development

In
the European Union, our future products also may be subject to extensive regulatory requirements. As in the United States, medicinal
products can be marketed only if a marketing authorization from the competent regulatory agencies has been obtained.

Similar
to the United States, the various phases of preclinical and clinical research in the European Union are subject to significant regulatory
controls. Although the EU Clinical Trials Directive 2001/20/EC has sought to harmonize the EU clinical trials regulatory framework, setting
out common rules for the control and