Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 107

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 107
---
 of these efforts remain uncertain pending the
outcomes of several federal lawsuits challenging state authority to regulate prescription drug payment limits. In December 2020, the U. S.
Supreme Court held unanimously that federal law does not preempt the states’ ability to regulate pharmaceutical benefit managers,
or PBMs, and other members of the healthcare and pharmaceutical supply chain, an important decision that may lead to further and
more aggressive efforts by states in this area. The Federal Trade Commission (FTC) in mid-2022 also launched sweeping investigations into
the practices of the PBM industry that could lead to additional federal and state legislative or regulatory proposals targeting such entities’
operations, pharmacy networks, or financial arrangements. Significant efforts to change the PBM industry as it currently exists in the
U. S. may affect the entire pharmaceutical supply chain and the business of other stakeholders, including pharmaceutical product developers
like us.

We expect that additional foreign, federal and state healthcare
reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare
products and services, which could result in limited coverage and reimbursement and reduced demand for our products, once approved, or
additional pricing pressures.

58

Israeli Government Programs

Israel Innovation Authority

Before we in-licensed motixafortide, Biokine had received $2.7 million in funding for
the project from the IIA (formerly the OCS). As a condition for the IIA’s consent to our in-licensing of motixafortide, we
were required to agree to abide by any obligations resulting from such funding under the Israeli Encouragement of Industrial Research,
Development and Technological Innovation Law, 1984, and related regulations, as amended (the Research Law). Under the Research Law
and the terms of IIA grants, royalties on the revenues derived from sales of products (and associated services) developed with IIA funding
are payable to the Israeli government, generally at the rate of 3% (and at an increased rate under certain circumstances, as described
below). The obligation to make these royalty payments terminates upon repayment of the amount of grants, linked to the U. S. dollar, plus
interest (in accordance with IIA regulations), which amount may be increased under certain circumstances, as described below.

Under the Research Law, the transfer or license to third parties
outside of Israel of know-how or technologies developed under IIA-funded programs, or the transfer to third parties outside of Israel