Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2202

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2202
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, CMOs, strategic collaborators and others. We expect to continue to negotiate budgets and contracts with such
third parties, which may result in delays to our development timelines and increased costs.

90

We
will rely especially heavily on third parties over the course of our preclinical studies and clinical trials, and, as a result, we control
only certain aspects of their activities. As a result, we have less direct control over the conduct, timing and completion of our preclinical
studies and clinical trials and the management of data developed through preclinical studies and clinical trials than would be the case
if we relied entirely upon our own staff. Nevertheless, we are responsible for ensuring that each of our studies and trials are conducted
in accordance with the applicable protocol, legal and regulatory requirements and scientific standards, and our reliance on third parties
does not relieve us of our regulatory responsibilities. We and these third parties are required to comply with GCP and cGMP requirements,
which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for product candidates in clinical
development. Regulatory authorities enforce these GCP and cGMP requirements through periodic inspections of trial sponsors, clinical
investigators, manufacturers and trial sites. If we or any of these third parties fail to comply with applicable GCP or cGMP requirements,
the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities
may require us to suspend or terminate these trials or perform additional preclinical studies or clinical trials before approving our
marketing applications. We cannot be certain that, upon inspection, such regulatory authorities will determine that any of our clinical
trials comply with the GCP or cGMP requirements.

Our
failure or any failure by these third parties to comply with these regulations may require us to repeat clinical trials, which would
delay the regulatory approval process. Failure by us or by third parties we engage to comply with regulatory requirements can also result
in fines, adverse publicity, and civil and criminal sanctions. Moreover, our business may be implicated if any of these third parties
violates federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.

Any
third parties conducting aspects of our preclinical studies, clinical trials or manufacturing process will not be our employees and,
except for remedies that may be available to us under our agreements with such third parties, we cannot control whether or not they devote
sufficient time and resources to our preclinical studies and clinical programs. These third parties may