FARMAK, a.s. CZECH REPUBLIC

INTRODUCTION FARMAK, a.s. Czech, privately owned, independent middle-sized company with the tradition of industrial chemical production dates back to the year 1934. Globally active Flexible, reliable and customer oriented partner Focused on R&D and manufacturing of: niche API´s advanced intermediates Supportive in dossier development Customer and employees oriented – The Essential is Inside Farmak, a.s.

LOCATION FARMAK is easily accesible! Olomouc - Vienna = 190 km Olomouc - Prague = 280 km Olomouc - Brno = 80 km Farmak, a.s.

HISTORY 1934 - start of industrial chemical production 1952 - establishment of state-owned company Farmakon (member of Spofa) 1992 - registration of joint-stock company FARMAK 1996 - Farmakon acquired by FARMAK (privatisation) 2004 - new R&D and QA/QC centre construction 2008 - installation of new cGMP kilolab 2014 - new Hall of Final Operations (HAFO) construction 2015 - new multipurpose production line installed 2016 - climatic chambers with water cooling system - particle size distribution measurement on Malvern instrument 2017 - comprehensive Drying and Homogenization Technology Line Farmak, a.s.

SALES AND MARKET More than 130 business partners across the world Export level in sales around 90% Farmak, a.s.

HUMAN RESOURCES Approx. 250 employees STRUCTURE EDUCATION Farmak, a.s.

QUALITY MANAGEMENT SYSTEM Compliance with international cGMP standards: EU GMP Eudralex Volume 4, Part 2; ICH Q7; US FDA CFR’s and customer’s Quality Assurance Agreements Inspected by authorities on regular basis Czech State Institute for Drug Control US Food and Drug Administration Approved by ISO 9 001 & ISO 14 001 International Standarts Certified Integrated System of QC and Environmental Protection DMF & CEP Regulatory Documentation available Farmak, a.s.

CHEMICAL EXPERTISE Chemistry of heterocyclic compounds Grignard reactions Various condensations Friedel - Crafts reactions Halogenations Oxidations Catalytic hydrogenations Esterifications Racemic mixture separations Reductions (Zn, catalytic hydrogenations) Farmak, a.s.

PRODUCTION FACILITIES Facilities area: approx. 36,000 m2 2 GMP production halls (one is FDA approved) Hall of Final Operations: milling micronizing sieving packaging Supporting facilities: warehousing waste water treatment water purification Facility is ready to expand! Farmak, a.s.

PRODUCTION HALLS reactors Pfaudler Glass-lined, stainless steel jacketed reactors (typical volume is 1,600 litres) Total reactor capacity: 100 m3 Batch size 5 - 250 kg Reaction temperatures: between -20 and +300 °C Reaction pressure: between -80 and +300 kPa Product separation - centrifuges, filters, filter/driers (some of them of Hastelloy C22) Drying equipment (some of them of Hastelloy C22 bag filters MAAP Farmak, a.s.

KILOLAB Büchi ChemReactor CR: 2 x 60 L, 1 x 15 L highest level of cGMP requirements Büchi ChemReactor CR: 2 x 60 L, 1 x 15 L Cryogenic technology (down to -90°C) Glove box Mobile pressure filter HVAC system Utility systems: non-water heating/cooling medium process nitrogen, process vacuum, hot water Protected area for raw material dispensing  0.2 – 5 kg batches Farmak, a.s.

HALL OF FINAL OPERATIONS Milling/micronization Sieving Custom packaging HVAC system Farmak, a.s.

R&D AND QA/QC CENTRE Analytical Centre – QC Department production sample service – raw materials, intermediates, final samples documentation – SOP’s, analytical instructions, CoA’s standards, stability studies, validation of methods, water and air monitoring R&D Analytical Department structural analyses purity analyses/impurity profile development of analytical methods Instrumentation LCMS, GCMS, GC, HPLC/TLC Capillary Electrophoresis NMR, UV/VIS a IR Spectrometry, XRay DSC Laser Particle Size Analyses (Cilas+Malvern) Farmak, a.s.

ECOLOGY AND SAFETY Environmental policy in line with FARMAK’s strategy Involvement in the national System of Assistance in Accidents Related to Transportation of Dangerous Materials Certified integrated system ISO9001 and ISO14001 Own waste water treatment plant RESPONSIBLE CARE certificate holder for 20 years Approved by SEDEX – Ethical and Responsible Supply Chain since 2015, site reference ZS1073996 Farmak, a.s.

CONTACTS Feel free to contact us through our websites www.farmak.cz Phone: +420 587 430 111, +420 585 547 111 Fax: +420 585 231 424, +420 585 231 735 E-mail: ceo@farmak.cz Address: FARMAK, a. s. Na vlčinci 16/3, Klášterní Hradisko 779 00 OLOMOUC, CZECH REPUBLIC You can also follow us on LinkedIn FARMAK, a.s