Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3442

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3442
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 information related to certain payments or other transfers
of value made or distributed to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors) and teaching
hospitals, or to entities or individuals at the request of, or designated on behalf of, physicians, and teaching hospitals and to report
annually certain ownership and investment interests held by physicians, certain other healthcare professionals, and their immediate family
members. Beginning in 2022, applicable manufacturers will also be required to report information regarding payments and other transfers
of value provided during the previous year to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse
anesthetists, anesthesiologist assistants, and certified nurse-midwives. In addition, many states also govern the reporting of payments
or other transfers of value, many of which differ from each other in significant ways, are often not pre-empted, and may have a more
prohibitive effect than the Sunshine Act, thus further complicating compliance efforts.

Similar
federal, state and foreign fraud and abuse laws and regulations, such as state anti-kickback and false claims laws, may apply to sales
or marketing arrangements and claims involving healthcare items or services. Such laws are generally broad and are enforced by various
state agencies and private actions. Also, many states have similar fraud and abuse statutes or regulations that may be broader in scope
and may apply regardless of payor, in addition to items and services reimbursed under Medicaid and other state programs. Some state laws
require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant
federal government compliance guidance, and require drug manufacturers to report information related to payments and other transfers
of value to physicians and other healthcare providers or marketing expenditures.

57

In
order to distribute products commercially, we must comply with state laws that require the registration or licensure of manufacturers
and wholesale distributors of drug and biological products in a state, including, in certain states, manufacturers and distributors who
ship products into the state even if such manufacturers or distributors have no place of business within the state. Several states have
enacted legislation requiring pharmaceutical and biotechnology companies to establish marketing compliance programs, file periodic reports
with the state, make periodic public disclosures on sales, marketing, pricing, clinical trials and other activities, and/or register
their sales representatives, as well as to prohibit pharmacies and other healthcare entities from providing certain physician prescribing
data to pharmaceutical and biotechnology companies for use