Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 92

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 92
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healthcare statutory and regulatory requirements and oversight by federal and state governments in the United States as well as foreign
governments in the jurisdictions in which we conduct our business. Healthcare providers, physicians and third-party payors in the United
States and elsewhere play a primary role in the recommendation and prescription of drug and biological products. Arrangements with third-party
payors and customers can expose pharmaceutical manufacturers to broadly applicable fraud and abuse and other healthcare laws and regulations,
including, without limitation, the federal Anti-Kickback Statute, or AKS, and the False Claims Act, or FCA, which may constrain the business
or financial arrangements and relationships through which such companies sell, market and distribute pharmaceutical products. In particular,
the research of any of our product candidates, as well as the promotion, sales and marketing of healthcare items and services, as well
as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing
and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion,
structuring and commission(s), certain customer incentive programs and other business arrangements generally. Activities subject to these
laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials.

The healthcare laws that may
affect us include: the federal fraud and abuse laws, including the AKS; false claims and civil monetary penalties laws, including the
FCA and Civil Monetary Penalties Law; federal data privacy and security laws, including HIPAA, as amended by HITECH; and the federal Physician
Payments Sunshine Act related to ownership and investment interests held by physicians and their immediate family members, as well as
payments and/or other transfers of value made to physicians, certain advanced non-physician healthcare practitioners and teaching hospitals.
In addition, many states have similar laws and regulations that may differ from each other and federal law in significant ways, thus complicating
compliance efforts. Moreover, several states require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary
compliance guidelines and the relevant compliance guidance promulgated by the federal government and may require manufacturers to report
information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures. Additionally,
some state and local laws require the registration of pharmaceutical sales representatives in the jurisdiction.

The scope and enforcement
of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light