Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2652

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2652
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 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
    of a REMS, which may include distribution or use restrictions;

    ●
    requirements
    to conduct additional post-market clinical trials to assess the safety of the product;

    ●
    fines,
    warning letters or holds on clinical trials;

    ●
    refusal
    by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of license
    approvals;

    ●
    product
    seizure or detention or refusal to permit the import or export of our product candidates; and

    ●
    injunctions
    or the imposition of civil or criminal penalties.

The
FDA’s and other regulatory authorities’ policies may change and additional government regulations may be enacted that could
prevent, limit or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature or extent of government
regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or
unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain
regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.

The
FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.

The
FDA and other regulatory agencies strictly regulate the post-approval marketing, labeling, advertising, and promotion of products that
are placed on the market. The FDA and other regulatory agencies impose stringent restrictions on sponsors’ communications regarding
off-label use. Products may be promoted only for the approved indications and in accordance with the provisions of the approved label.
However companies may share truthful and not misleading information that is not inconsistent