Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2156

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2156
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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 laws governing international business practices may result in substantial civil and criminal penalties and suspension
or debarment from government contracting. The SEC also may suspend or bar issuers from trading securities on United States exchanges
for violations of the FCPA’s accounting provisions.

Coverage
and Reimbursement

Successful
commercialization of new drug products depends in part on the extent to which reimbursement for those drug products will be available
from government health administration authorities, private health insurers, and other organizations. Government authorities and third-party
payors, such as private health insurers and health maintenance organizations, decide which drug products they will pay for and establish
reimbursement levels. The availability and extent of reimbursement by governmental and private payors is essential for most patients
to be able to afford a drug product.