Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2591

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2591
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 future clinical trials we may operate in developing countries;

    ●
    we
    may elect to, or regulators, IRBs, Data Safety Monitoring Boards, or DSMBs, or ethics committees may require that we or our investigators,
    suspend or terminate clinical research or trials for various reasons, including noncompliance with regulatory requirements or a finding
    that the participants are being exposed to unacceptable health risks;

    ●
    we
    may not have the financial resources available to begin and complete the planned trials, or the cost of clinical trials of any product
    candidates may be greater than we anticipate;

    ●
    the
    supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may
    be insufficient or inadequate to initiate or complete a given clinical trial; and

    ●
    the
    FDA or other comparable foreign regulatory authorities may require us to submit additional data such as long-term toxicology studies,
    or impose other requirements before permitting us to initiate a clinical trial.

We
could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs or ethics committees of the institutions
in which such clinical trials are being conducted, or by the FDA or other regulatory authorities. Such authorities may suspend or terminate
a clinical trial due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements
or our clinical trial protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities
resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from
the product candidates, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical
trial.

81

Moreover,
principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation
in connection with such services. Under certain circumstances, we may be required to report some of these relationships to the FDA or
comparable foreign regulatory authorities. The FDA or comparable foreign regulatory authority may conclude that a financial relationship
between us and a principal investigator has created a conflict of interest or otherwise affected interpretation of the study. The FDA
or comparable foreign regulatory authority may therefore question the integrity of the data generated at the applicable clinical trial
site and the utility of the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection, of our
marketing applications by the FDA or comparable foreign regulatory