Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 206

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 206
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ulatory measures.

Healthcare Law and Regulation

Healthcare providers, physicians
and third-party payors play a primary role in the recommendation and prescription of drug products that are granted marketing approval.
Arrangements with third-party payors and customers are subject to broadly applicable fraud and abuse and other healthcare laws and regulations.
Such restrictions under applicable federal and state healthcare laws and regulations include the following:

| • | the federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully                                    
 soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the    
 referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole 
 or in part, under a federal healthcare program such as Medicare and Medicaid; A person or entity does not need to have actual knowledge  
 of the Anti-Kickback Statute or specific intent to violate it to have committed a violation;                                             |

| • | the federal civil and criminal false claims laws and civil monetary penalty laws, including the federal                                    
 False Claims Act, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, false 
 or fraudulent claims for payment to, or approval by Medicare, Medicaid, or other federal healthcare programs, knowingly making, using      
 or causing to be made or used a false record or statement material to a false or fraudulent claim or an obligation to pay or transmit      
 money to the federal government, or knowingly concealing or knowingly and improperly avoiding or decreasing or concealing an obligation    
 to pay money to the federal government. Manufacturers can be held liable under the FCA even when they do not submit claims directly to     
 government payers if they are deemed to “cause” the submission of false or fraudulent claims. The FCA also permits a private               
 individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the FCA                 
 and to share in any monetary recovery;                                                                                                     |

| • | the Civil Monetary Penalties Law, which prohibits, among other things, the offering or giving of remuneration,                               
 which includes, without limitation, any transfer of items or services for free or for less than fair market value (with limited exceptions), 
 to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of             
 a particular supplier of items or services reimbursable by a