Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2668

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2668
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opharmaceutical partners
to continue to use our products and solutions due to the potential risk exposure as a result of the current (and, in particular, future)
data protection obligations imposed on them by certain data protection authorities in interpretation of current law, including the GDPR.
Such clients or biopharmaceutical partners may also view any alternative approaches to compliance as being too costly, too burdensome,
too legally uncertain, or otherwise objectionable and therefore decide not to do business with us. Any of the forgoing could materially
harm our business, prospects, financial condition and results of operations.

Additional
laws and regulations governing international operations could negatively impact or restrict our operations.

121

If
we expand our operations outside of the United States, we must dedicate additional resources to comply with numerous laws and regulations
in each jurisdiction in which we plan to operate. The U.S. Foreign Corrupt Practices Act, or the FCPA, prohibits any U.S. individual
or business entity from paying, offering, authorizing payment or offering of anything of value, directly or indirectly, to any foreign
official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the
individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the United
States to comply with certain accounting provisions requiring the company to maintain books and records that accurately and fairly reflect
all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal
accounting controls for international operations.

Compliance
with the FCPA is expensive and difficult, particularly in countries in which corruption is a recognized problem. In addition, the FCPA
presents particular challenges in the biopharmaceutical industry, because, in many countries, hospitals are operated by the government,
and doctors and other hospital employees are considered foreign officials. Certain payments to hospitals and healthcare providers in
connection with clinical trials and other work have been deemed to be improper payments to government officials and have led to FCPA
enforcement actions.

Various
laws, regulations and executive orders also restrict the use and dissemination outside of the United States, or the sharing with certain
non-U.S. nationals, of information products classified for national security purposes, as well as certain products, technology and technical
data relating to those products. If we expand our presence outside of the United States, it will require us to dedicate additional resources
to comply with these laws, and these laws