Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 187

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 4
Chunk 187
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 to prevent us from using our marks, consequently impeding our ability to build brand identity and possibly leading to customer confusion.
Manufacturing
 
We rely on contract manufacturers to produce motixafortide for clinical trials and commercial sales. We have contracted with third-party manufacturers for the manufacture of the API for motixafortide, the supply of finished product for both commercial use and our clinical programs, and for labeling and packaging. In addition, under the Gloria License Agreement, the Gloria Licensee may in the future serve as an additional source for the manufacture of the API for motixafortide. To the extent possible and commercially practicable, we plan to develop back-up strategies for raw materials, manufacturing and testing services for our commercial products. Given the long lead times and cost of establishing additional commercial manufacturing sites, we expect that we will rely on single contract manufacturers to produce motixafortide for the foreseeable future. Our manufacturing partners have a limited number of facilities in which our therapeutic candidates can be produced.
 
In connection with the Ayrmid License Agreement, we and Ayrmid also entered into the Supply Agreement, according to which we will supply motixafortide to Ayrmid during the term of the Ayrmid License Agreement, on a cost-plus basis, for both commercial and development supply. Furthermore, the Supply Agreement provides Ayrmid with “step-in rights” with respect to the manufacture and supply of motixafortide upon the occurrence of certain trigger events.
 
Our laboratories are located in our headquarters in Modi’in, Israel, and are in part compliant with FDA regulations setting forth current good laboratory practices, or GLP. While our bioanalytical laboratory complies with these regulations, the chemistry and formulation laboratories, as well as the analytical laboratories, are limited in manufacturing scale and resources and therefore are intended to support our projects for research and development activities only. These laboratories are not compliant with current good manufacturing practices, or cGMP. Hence, we cannot independently manufacture drug substances or drug products for our current clinical trials or for commercial distribution.
 
Our current and any future third-party manufacturers, their facilities and all lots of drug substance and drug products used in our clinical trials and commercial sales are required to be in compliance with cGMP. The cGMP regulations include requirements relating to organization of personnel, buildings and facilities, equipment, control of components and drug product containers and closures, production and process controls, packaging and labeling controls, holding and distribution, laboratory controls, records and reports, and returned or salvaged products. The manufacturing