Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 94

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 94
---
 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 of
the lack of applicable precedent and regulations. Ensuring business arrangements comply with applicable healthcare laws, as well as responding
to possible investigations by government authorities, can be time- and resource-consuming and can divert a company’s attention from
other aspects of its business.

It is possible that governmental
and enforcement authorities will conclude that our business practices may not comply with current or future statutes, regulations or case
law interpreting applicable fraud and abuse or other healthcare laws and regulations. If any such actions are instituted against us, and
we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including
the imposition of significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, reputational harm,
possible exclusion from participation in federal and state funded healthcare programs, contractual damages and the curtailment or restricting
of our operations, as well as additional