Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2607

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2607
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 effectively. If we are not successful in commercializing our products, either on our own or through arrangements
with one or more third parties, we may not be able to generate any future product revenue and we would incur significant additional losses.

Risks
Related to Our Reliance on Third Parties For Our Product Development

We
rely on third parties to conduct all or certain aspects of our preclinical studies and clinical trials. If these third parties do not
successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to
obtain regulatory approval of or commercialize any potential product candidates.

We
depend upon third parties to conduct all or certain aspects of our preclinical studies and clinical trials, under agreements with universities,
medical institutions, CROs, 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