Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 24

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 24
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 resulting                    

  impact on our reputation in the marketplace                                            

  the possible breach of the manufacturing                                 

  the possible termination or nonrenewal of                                                                                 

The failure of any of our contract manufacturers to maintain high
manufacturing standards could result in injury or death of clinical trial participants or patients being treated with our products. Such
failure could also result in product liability claims, product recalls, product seizures or withdrawals, delays or failures in testing
or delivery, cost overruns or other problems, which would have a material adverse effect on our business, financial condition and results
of operations.

15

Our contract manufacturers
are, and will be, subject to FDA and other comparable agency regulations.

Our contract manufacturers are, and will be, required to adhere
to FDA regulations setting forth current good manufacturing practices, or cGMP, for drugs. These regulations cover all aspects of the
manufacturing, testing, quality control and recordkeeping relating to our therapeutic candidates. Our manufacturers may not be able to
comply with applicable regulations. Our manufacturers are and will be subject to unannounced inspections by the FDA, state regulators
and similar regulators outside the United States. The failure of our third-party manufacturers to comply with applicable regulations could
result in the imposition of sanctions on us, including fines, injunctions, civil penalties, failure of regulatory authorities to grant
marketing approval of our therapeutic candidates, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls
of our candidates or products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect
regulatory approval and supplies of our therapeutic candidates, and materially and adversely affect our business, financial condition
and results of operations.

Our business could suffer
if we are unable to attract and retain key employees.

Our success depends upon the continued service and performance
of our senior management and other key personnel. The loss of the services of these personnel could delay or prevent the successful completion
of our planned clinical trials or the commercialization of our therapeutic candidates or otherwise affect our ability to manage our company
effectively and to carry out our business plan. We do not maintain key-man life insurance. Although we have entered into employment agreements
with all of the members of our senior management team, members of our senior management team may resign at any time subject to prior notice
as applicable. High demand exists for senior management and other key personnel in the pharmaceutical industry. There can be no assurance
that we will be able to continue to retain and attract such personnel