Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2247

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2247
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    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 with the labeling. The FDA and other agencies
actively enforce the laws and regulations prohibiting the promotion of off-label uses and a company that is found to have improperly
promoted off-label uses may be subject to significant liability. The federal government has levied large civil and criminal fines against
companies for alleged improper promotion of off-label use and has enjoined several companies from engaging in off-label promotion. Violation
of the Federal Food, Drug, and Cosmetic Act, or the FDCA, and other statutes, including the False Claims Act, and equivalent legislation
in other countries relating to the promotion and advertising of prescription products may also lead to investigations or allegations
of violations of federal and state and other countries’ health care fraud and abuse laws and state consumer protection laws. Even
if it is