Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 103

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 103
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own prices for drug products but monitor and control company profits and issue guidance to prescribers. The downward pressure on health
care costs in general, particularly prescription drugs, has become intense. As a result, increasingly high barriers are being erected
to the entry of new products. In addition, reference pricing and cross-border imports from low-priced markets exert competitive pressure
that may reduce pricing within a country. Any country that has price controls or reimbursement limitations for drug products may not allow
favorable reimbursement and pricing arrangements.

Other Healthcare Laws and Regulation

Healthcare providers and third-party payors play a primary role
in the recommendation and prescription of drug products that are granted regulatory approval. Arrangements with providers, consultants,
third-party payors and customers are subject to broadly applicable fraud and abuse and other healthcare laws and regulations that may
constrain our business and/or financial arrangements. Such restrictions under applicable federal and state healthcare laws and regulations
include the following:

  the federal Anti-Kickback Statute, which prohibits, among other                                                                               
  things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration (including any kickback,  
  bribe or rebate), directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase,  
  lease or order 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;                                                                                                                        
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  the federal civil and criminal false claims laws, including                                                                                     

56

  the federal Health Insurance Portability and Accountability                                                                                  

  HIPAA, as amended by the Health Information Technology for                                                                                  
  Economic and Clinical Health Act and its implementing regulations, which also imposes obligations, including mandatory contractual terms,   
  with respect to safeguarding the privacy, security and transmission of individually identifiable health information on covered entities     
  and their business associates that associates that perform certain functions or activities that involve the use or disclosure of protected  
  health information on their behalf;                                                                                                         
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  the Foreign Corrupt Practices Act, or FCPA, which prohibits                                                                                

  the federal transparency requirements known as the federal                                                                                     
  Physician Payments Sunshine Act, under the Patient Protection