Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2561

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2561
---
 clinical trials, product licensing, pricing and reimbursement vary from country to country. Additionally,
the clinical trials must be conducted in accordance with GCP requirements and the applicable regulatory requirements and the ethical
principles that have their origin in the Declaration of Helsinki.

If
we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal
of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

Additional
Laws and Regulations Governing International Operations

If
we further 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 Foreign Corrupt Practices Act, or FCPA, prohibits any United States
individual or business 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 pharmaceutical 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 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-United States nationals, of information classified for national security purposes, as well as certain products 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 may preclude us from developing, manufacturing, or selling certain products and product candidates
outside of the United States, which could limit our growth potential and increase our development costs.

64

The
failure to comply with