Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2564

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2564
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B drug pricing is determined based on AMP and Medicaid rebate data, the revisions
to the Medicaid rebate formula and AMP definition described above could cause the required 340B discount to increase. The American Recovery
and Reinvestment Act of 2009 provides funding for the federal government to compare the effectiveness of different treatments for the
same illness. The plan for the research was published in 2012 by HHS, the Agency for Healthcare Research and Quality and the National
Institutes for Health, and periodic reports on the status of the research and related expenditures are made to Congress. Although the
results of the comparative effectiveness studies are not intended to mandate coverage policies for public or private payors, it is not
clear what effect, if any, the research will have on the sales of our drug candidates, if any such drug or the condition that they are
intended to treat are the subject of a trial. It is also possible that comparative effectiveness research demonstrating benefits in a
competitor’s drug could adversely affect the sales of our drug candidate. If third-party payors do not consider our drugs to be
cost-effective compared to other available therapies, they may not cover our drugs after approval as a benefit under their plans or,
if they do, the level of payment may not be sufficient to allow us to sell our drugs on a profitable basis.

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 product candidates for which we may obtain
regulatory approval or the frequency with which any such product candidate is prescribed or used.

Outside
of the United States, the pricing of pharmaceutical products and medical devices is subject to governmental control in many countries.
For example, in the European Union, pricing and reimbursement schemes vary widely from country to country. Some countries provide that
products may be marketed only after a reimbursement price has been agreed. Some countries may require the completion of additional studies
that compare the cost effectiveness of a particular therapy to currently available therapies or so-called health technology assessments,
in order to obtain reimbursement or pricing approval. Other countries may allow companies to fix their own prices for products, but monitor
and control product volumes and issue guidance to physicians to limit prescriptions. Efforts to control prices and utilization of pharmaceutical
products and medical devices will likely continue as countries attempt to manage healthcare expenditures.

Employees
and Human Capital

As
of December 31, 2024