Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3546

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3546
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, sampling, record-keeping, conduct of post-marketing studies and submission of safety, efficacy and other
post-market information, including both federal and state requirements in the United States and requirements of comparable foreign regulatory
authorities. In addition, we will be subject to continued compliance with cGMP and GCP requirements for any clinical trials that we conduct
post-approval.

Manufacturers
and their facilities are required to comply with extensive FDA and comparable foreign regulatory authority requirements, including ensuring
that quality control and manufacturing procedures conform to cGMP regulations. As such, we and our contract manufacturers will be subject
to continual review and inspections to assess compliance with cGMP and adherence to commitments made in any marketing application, and
previous responses to inspection observations. Accordingly, we and others with whom we work must continue to expend time, money, and
effort in all areas of regulatory compliance, including manufacturing, production and quality control.

Any
regulatory approvals that we receive for our product candidates may be subject to limitations on the approved indicated uses for which
the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing,
including Phase 4 clinical trials and surveillance to monitor the safety and efficacy of the product candidate. The FDA may also require
a risk evaluation and mitigation strategy, or REMS, as a condition of approval of our product candidates, which could entail requirements
for long-term patient follow-up, a medication guide, physician communication plans or additional elements to ensure safe use, such as
restricted distribution methods, patient registries and other risk minimization tools.

113

The
FDA may impose consent decrees or withdraw approval if compliance with regulatory requirements and standards is not maintained or if
problems occur after the product reaches the market. Later discovery of previously unknown problems with our product candidates, including
adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to
comply with regulatory requirements, may result in, among other things:

    ●
    restrictions
    on the marketing or manufacturing of our products, withdrawal of the product from the market or voluntary or mandatory product recalls;

    ●
    manufacturing
    delays and supply disruptions where regulatory inspections identify observations of noncompliance requiring remediation;

    ●
    revisions
    to the labeling, including limitation on approved uses or the addition of additional warnings, contraindications or other safety
    information, including boxed warnings;

    ●
    imposition