Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3548

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3548
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 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 of certain branded prescription drugs, and created a new Medicare Part D coverage gap discount program,
in which manufacturers must agree to offer 70% (increased pursuant to the Bipartisan Budget Act of 2018, or BBA, effective as of 2019)
point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as
a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D.

Since
its enactment, there have been numerous judicial, administrative, executive, and legislative challenges to certain aspects of the ACA,
and we expect there will be additional challenges and amendments to the ACA in the future. Various portions of the ACA are currently
undergoing legal and constitutional challenges in the United States Supreme Court. It is unclear how such