Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2653

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2653
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 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 later determined we were not in violation of these laws, we may be faced with negative publicity, incur significant expenses
defending our actions and have to divert significant management resources from other matters. If we cannot successfully manage the promotion
of our product candidates, if approved, we could become subject to significant liability, which would materially adversely affect our
business and financial condition.

114

Ongoing
healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations.

Changes
in regulations, statutes or the interpretation of existing regulations could impact our business in the future by requiring, for example:
(i) changes to our manufacturing and distribution arrangements; (ii) additions or modifications to product labeling; (iii) the recall
or discontinuation of our products; or (iv) additional record-keeping requirements. If any such changes were to be imposed, they could
adversely affect the operation of our business.

In
the United States, there have been and continue to be a number of legislative initiatives to contain healthcare costs. For example, in
March 2010, the Patient Protection and Affordable Care Act, or ACA, was passed, which substantially changed the way health care is financed
by both governmental and private insurers, and significantly impacted the U.S. biopharmaceutical industry. The ACA, among other things,
addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that
are inhaled, infused, instilled, implanted or injected, increased the minimum Medicaid rebates owed by manufacturers under the Medicaid
Drug Rebate Program and extended the rebate program to individuals enrolled in Medicaid managed care organizations, established annual
fees and taxes on manufacturers