Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2240

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2240
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 fraud.

We
are subject to certain reporting requirements of the Exchange Act. Our disclosure controls and procedures are designed to reasonably
assure that information required to be disclosed by us in reports we file or submit under the Exchange Act is accumulated and communicated
to management, recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC. We believe
that any disclosure controls and procedures or internal controls and procedures, no matter how well conceived and operated, can provide
only reasonable, not absolute, assurance that the objectives of the control system are met. These inherent limitations include the realities
that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls
can be circumvented by the individual acts of some persons, by collusion of two or more people or by an unauthorized override of the
controls. Accordingly, because of the inherent limitations in our control system, misstatements or insufficient disclosures due to error
or fraud may occur and not be detected.

Risks
Related to Marketing, Reimbursement, Healthcare Regulations and Ongoing Government Regulatory Compliance

Coverage
and reimbursement may be limited or unavailable in certain market segments for our product candidates, if approved, which could make
it difficult for us to sell any product candidates profitably.

Significant
uncertainty exists as to the coverage and reimbursement status of any products for which we may obtain regulatory approval. In the United
States, sales of any products for which we may receive regulatory marketing approval will depend, in part, on the availability of coverage
and reimbursement from third-party payors. Third-party payors include government authorities such as Medicare, Medicaid, TRICARE, and
the Veterans Administration, managed care providers, private health insurers, and other organizations. Patients who are provided medical
treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment.
Coverage and adequate reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors are critical
to new product acceptance. Patients are unlikely to use our product candidates unless coverage is provided and reimbursement is adequate
to cover a significant portion of the cost. We cannot be sure that coverage and reimbursement will be available for, or accurately estimate
the potential revenue from, our product candidates or assure that coverage and reimbursement will be available for any product that we
may develop.

110

Government
authorities and other third-party payors decide which drugs and treatments they will cover and the