Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2658

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2658
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, beginning with ten high-cost drugs paid for by Medicare
Part D starting in 2026, followed by 15 Part D drugs in 2027, 15 Part B or Part D drugs in 2028, and 20 Part B or Part D drugs in 2029
and beyond. The legislation subjects drug manufacturers to civil monetary penalties and a potential excise tax for failing to comply
with the legislation by offering a price that is not equal to or less than the negotiated “maximum fair price” under the
law or for taking price increases that exceed inflation. The legislation also caps Medicare beneficiaries’ annual out-of-pocket
drug expenses at $2,000. The effect of the Inflation Reduction Act of 2022 on our business and the healthcare industry in general is
not yet known.

At
the state level, legislatures are increasingly passing legislation and implementing regulations designed to control biopharmaceutical
and biologic product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access
and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and
bulk purchasing.

These
laws, and future state and federal healthcare reform measures may be adopted in the future, any of which may result in additional reductions
in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any of our product candidates for which we
may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used. Additionally, we expect
to experience pricing pressures in connection with the sale of any future approved product candidates due to the trend toward managed
healthcare, the increasing influence of health maintenance organizations, cost containment initiatives and additional legislative changes.

Inadequate
funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel,
prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from
performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

The
ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding
levels, passage of federal FDA user fee legislation every five years, ability to hire and retain key personnel and accept the payment
of user fees, public health emergencies, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated
in recent years as a result. In