Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2608

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2608
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 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 also have relationships with
other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other product development
activities, which could affect their performance on our behalf. If these third parties do not successfully carry out their contractual
duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the preclinical or clinical
data they obtain is compromised due to the failure to adhere to our protocols or regulatory requirements or for other reasons or if due
to federal or state orders or other such crises they are unable to meet their contractual
and regulatory obligations, our development timelines, including clinical development timelines, may be extended, delayed or terminated
and we may not be able to complete development of, obtain regulatory approval of or successfully commercialize our product candidates.
As a result, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase
and our ability to generate revenue could be delayed.

If
any of our relationships with these third-party CROs, CMOs or others terminate, we may not be able to enter into arrangements with alternative
CROs, CMOs or other third parties or to do so on commercially reasonable terms.

Switching
or adding additional CROs or CMOs involves additional cost and requires extensive time and focus of our management. In addition, there
is a natural transition period when a new CRO or CMO begins work. As a result, delays may occur, which can materially impact our ability
to meet our desired development timelines.

Though
we carefully manage our relationships with our CROs and CMOs, there can be no assurance that we will not encounter similar challenges
or