SERION Immunologics Competence in Antigens...

Transcription

1 Competence in Antigens... for diagnostics of infectious diseases, Friedrich-Bergius-Ring 19, D Würzburg, Germany Phone: , Fax: Internet:

2 Institut Virion\Serion GmbH is one of the leading manufacturers of infection serology ELISA diagnostics. The company has developed more than 100 highly specific and sensitive test systems for serological detection of infectious diseases. With subsidiaries in China & Brazil and a global network of distributors we are selling our products consistently and successfully in more than 100 countries worldwide. With extensive expertise in the manufacturing of high-grade serological antigens, Institut Virion\Serion recently launched their new division. offers various highly purified native and recombinant bulk antigens to detect pathogen specific antibodies from viral, bacterial or fungal origins. The product portfolio is complemented by the corresponding disease state plasma/sera, various bulk raw materials and customer specific services. Products manufactures and provides a wide range of antigens and diagnostic raw materials and services such as: Antigens Disease state sera Bovine Serum Albumin Basic and special reagents Customized services High flexibility, experienced employees and competent customer support makes your partner in ANTIGEN sourcing

3 Quality Institut Virion\Serion GmbH is a certified IVD manufacturer according to European IVD directive 98/79/EC. All diagnostic medical devices are CE marked. Our quality management system is certified according to DIN EN ISO For Canada the quality management system complies to CMDCAS. Certificate: DIN EN ISO History 1978 Foundation of Institut Virion\Serion GmbH 1981 Market launch of first SERION ELISA classic 1986 Foundation of SERION Immundiagnostica GmbH 2000 CE Certification 2003 Base in China (Beijing) 2004 Relocation & expansion to new headquarters 2007 Market launch of Immunomat TM 2010 Subsidiary in Brazil (Curitiba) 2011 Expansion of R&D department (Center of Excellence) 2012 Expansion of Antigen Production department 2013 Launch of Friedrich-Bergius-Ring 19 D Würzburg, Germany Phone: Fax: info@serion-immunologics Internet:

4 Table of contents Introduction I. Bulk Antigens Native Bacterial Antigens... 6 Native Viral Antigens... Native Parasitic Antigens... Native Mycological Antigens Recombinant Antigens II. Sera & Plasma Disease State Sera III. Bulk Reagents & Components Bovine Serum Albumin, Standard grade Bovine Serum Albumin, Protease free Bovine Serum Albumin, Fatty Acid free Bovine Serum Albumin, Sulfydryl blocked... Bovine Serum Albumin, 30 % solution IV. Customized Services ELISA Coating Lyophilization

5 Bulk Antigens Institut Virion\Serion GmbH produces a wide range of highly pathogen specific antigens for the manufacturing of diagnostic tests like ELISA test systems and immunoblots. Currently more than 80 different antigens are manufactured in our company facilities in Germany. With more than 35 years of experience in the production of infectious disease antigens, we are a well-known and widely recognized partner to the diagnostic industry, supplying antigens to our customers worldwide. Experienced employees and the high quality of our products is the key to your and our success. Sera & Plasma Human plasma and serum are essential reagents in diagnostic test systems. Intended for use as calibrators or controls they are key factors in diagnostic applications. Being a manufacturer of infectious disease antigens for more than 100 ELISA test systems also offers a wide range of specialty disease antibody positive and 100 negative sera. Bulk Antigens Sera & Plasma Bovine Serum Albumin Bovine serum albumin (BSA) is a globular serum protein (~66.5 kda). Due to its high stability and lack of interference in many biological reactions, BSA is widely used in diagnostic test systems. Typical applications include use as protein calibrator, stabilizer and blocking agent. BSA is often referred to as Fraction V based on the original fractionation of human plasma developed by Edwin Cohn. Primarily developed for human albumin production the process was later adapted to Bovine Serum Albumin. In modern manufacturing processes, Cohn fractionation is now replaced by a modified, more effective heat shock method resulting in BSA of significantly higher degree of purity (> 98 %). now offers a variety of BSA products to cover the needs of the diagnostic industry. All bovine products are sourced from controlled abattoirs and are manufactured in the USA. All animals receive ante- and post-mortem inspections in order to meet regulatory requirements and are classified as free from infectious diseases and parasites. Bovine Serum Albumin Service Customer specific antigen projects can be realized in biological safety level 2 and 3 laboratories up to several grams. A fully automated state of the art production line can also offer customized ELISA coating, incubation and vacuum packaging. A gentle freeze-drying process is completing our service package. Service - 5 -

6 Bulk Antigens Competence in Antigens... High quality antigens are the key factor for the manufacturing of reliable and reproducible immunodiagnostic test systems. produces a variety of high quality infectious disease antigens for ELISA, particle based IVD and further commercial supply. Our mission is to maintain and continuously improve our high quality standards to meet the requirements of our customers. Constant development of new antigens as well as the optimization of existing production processes has led to a massive expansion of our production capacity. In our biosafety level 2 and 3 production areas, we currently manufacture more than 80 different antigens up to several grams per lot. All native antigen lots are verified to be pathogen inactivated and certified as non-infectious. Native Bacterial Antigens Standard amounts are 1.0 mg. Larger packaging units are available upon request. Test samples are available in 0.25 mg sizes. Antigen Product code Description Bordetella pertussis FHA BA120VS3 Filamentous hemagglutinin (FHA), highly purified from Bordetella pertussis (strain Tohama I) culture supernatant. Bordetella pertussis Toxin (PT) Bordetella pertussis whole-cell Antigen BA120VS4 BA120VS8 Pertussis toxin (PT), highly purified from Bordetella pertussis (strain Tohama I) culture supernatant. Bordetella pertussis (strain Tohama I) whole-cell antigen. Borrelia afzelii BA121VS Detergent extract of Borrelia afzelii, containing cytoplasmic and membrane components. Borrelia garinii BA121GVS Detergent extract of Borrelia garinii, containing cytoplasmic and membrane components. Brucella abortus BA116VS Detergent extract of Brucella abortus (strain S99 - Weybridge). Campylobacter jejuni BA139VS Detergent extract of the membrane fraction of Campylobacter jejuni (subsp. jejuni). Enriched for a 45 kda outer membrane protein

7 Bulk Antigens Antigen Product code Description Chlamydia abortus BA1373VSER Chlamydophila abortus (strain B-577) elementary and reticular bodies, purified. Chlamydia pneumoniae BA1371VSER Chlamydophila pneumoniae (TWAR strain TW-183) elementary and reticular bodies, purified. Chlamydia pneumoniae (Premium) BA1371VS Chlamydial outer membrane complexes (COMCs), prepared by detergent extraction of purified Chlamydophila pneumoniae (TWAR strain TW-183) elementary and reticular bodies. Chlamydia trachomatis BA1372VSER Chlamydophila trachomatis (LGV II strain 434) elementary and reticular bodies, purified. Helicobacter pylori BA118VS Detergent extract of Helicobacter pylori (type I strain), containing cytoplasmic and membrans components. Legionella pneumophila BA106VS Heat inactivated bacteria. Pool of Legionella pneumophila serovars 1-7. Leptospira biflexa BA125VS Alcohol extracted Leptospira biflexa (strain Patoc 1). Mycoplasma pneumoniae BA127VS Detergent extract of Mycoplasma pneumoniae (strain FH). Enriched for P1 adhesin protein. Yersinia enterocolitica O:3 BA138VS Yersinia outer proteins (YOPs), concentrated from culture medium of Yersinia enterocolitica, serovar 0:3. Yersinia enterocolitica O:8 BA13808VS Yersinia outer proteins (YOPs), concentrated from culture medium of Yersinia enterocolitica, serovar 0:8. Yersinia enterocolitica O:9 BA13809VS Yersinia outer proteins (YOPs), concentrated from culture medium of Yersinia enterocolitica, serovar 0:

8 Bulk Antigens Competence in Antigens... Native Viral Antigens Standard amounts are 1.0 mg. Larger packaging units are available upon request. Test samples are available in 0.25 mg sizes. Antigen Product code Description Adenovirus Type 2 Hexon BA128VS Chromatography purified Hexon protein from Adenovirus Type 2 (strain Adenoid 6). Coxsackievirus B1 * BA134B1VS Coxsackievirus B1 (strain Conn-5), partially purified viral lysate. Coxsackievirus B5 * BA134B5VS Coxsackievirus B5 (strain Faulkner), partially purified viral lysate. Coxsackievirus B6 * BA134B6VS Coxsackievirus B6 (strain Schmitt), partially purified viral lysate. Cytomegalovirus BA109VS Cytomegalovirus (strain Towne), partially purified viral lysate. Echovirus Type 6 * BA135VS Echovirus Type 6 (strain D Amori), partially purified viral lysate. Echovirus Type 9 * BA135-9VS Echovirus Type 9 (strain Hill), partially purified viral lysate. Herpes Simplex Virus 1 BA1051VS Herpes simplex virus 1 (strain F), purified viral lysate. Herpes Simplex Virus 2 BA1052VS Herpes simplex virus 2 (strain G), purified viral lysate. Influenza A Virus * BA1231VS Preparation of Influenza A Virus (strain Beijing) core particles, following removal of surface antigens. Influenza B Virus * BA1232VS Preparation of Influenza B Virus Antigen (strain Harbin) core particles, following removal of surface antigens. Measles Virus BA102VS Preparation of measles virus (strain Edmonston), partially purified. Measles Virus (Premium) BA102VS-S Preparation of measles virus (strain Edmonston), purified. * Upon request - 8 -

9 Bulk Antigens Antigen Product code Description Mumps Virus BA103VS Mumps virus (strain Enders), partially purified viral lysate. Parainfluenza Virus 1 BA1261VS Parainfluenza virus type 1 (strain Sendai), partially purified viral lysate. Parainfluenza Virus 2 BA1262VS Parainfluenza virus type 2 (strain Greer), partially purified viral lysate. Parainfluenza Virus 3 BA1263VS Parainfluenza virus type 3 (strain C 243), partially purified viral lysate. Respiratory Syncytial Virus BA113VS Respiratory syncytial virus (strain Long), partially purified viral lysate. Rubella Virus BA129G2VS Preparation of rubella virus (strain Judith), purified. Rotavirus BA1193VS Preparation of simian rotavirus (strain SA11), purified by chromatography. Rubella Virus Antigen - Premium BA129VS-E Preparation of rubella virus (strain HPV-77), highly purified. TBE Virus BA112VSL Preparation of tick-borne encephalitis virus (strain Moscow B-4), partially purified by ultracentrifugation. TBE Virus (Premium) BA112VS Preparation of tick-borne encephalitis virus (strain Moscow B-4), enriched for envelope glycoprotein, purified by chromatography. Varicella Zoster Virus BA104VS Varicella zoster virus (strain Ellen), purified viral lysate. Varicella Zoster Virus (VZV) Glycoprotein BA104VSG Affinity purified glycoproteins of varicella zoster virus (strain Ellen)

10 Bulk Antigens Competence in Antigens... Native Parasitic Antigens Standard amounts are 1.0 mg. Larger packaging units are available upon request. Test samples are available in 0.25 mg sizes. Antigen Product code Description Echinococcus granulosus BA107VS Bovine Echinococcus granulosus hydatid cyst fluid, sterile filtered, presented in stabilizing buffer. Toxoplasma gondii BA110VS Detergent extract of Toxoplasma gondii (strain RH) tachyzoites. Native Mycological Antigens Standard amounts are 1.0 mg. Larger packaging units are available upon request. Test samples are available in 0.25 mg sizes. Antigen Product code Description Aspergillus fumigatus BA132VS Cytoplasmic extract of Aspergillus fumigatus (strain AG-507). Candida albicans BA117VS Cellular extract of Candida albicans, contains cytoplasmic and cell wall components

11 Bulk Antigens SERION Immunologics

12 Bulk Antigens Competence in Antigens... In order to meet the requirements of a rapidly growing diagnostic market, Institut Virion\Serion GmbH has expanded its product portfolio accordingly. In addition to a variety of native antigens, offers numerous recombinant antigens for the diagnosis of bacterial and viral infections. Recombinant Antigens Standard amounts are 1.0 mg. Larger packaging units are available upon request. Test samples are available in 0.25 mg sizes. Antigen Product code Description Chlamydia trachomatis MOMP BA1372VSR2 Chlamydia trachomatis, fragment of MOMP (major outer membrane protein). Coxsackievirus Antigen recombinant BA134VS01 Proprietary Coxsackievirus antigen. EBV Capsid Antigen P18 BA1361VSR22 Epstein-Barr virus (EBV), recombinant capsid antigen P18. EBV Capsid Antigen P23 BA1361VSR21 Epstein-Barr virus (EBV), recombinant capsid antigen P23. Echovirus Antigen recombinant Enterovirus Antigen recombinant BA135VS01 BA133VS01 Proprietary Echovirus antigen. Proprietary Enterovirus antigen. HSV-1 Glycoprotein G BA1051RVS-G The protein contains an internal fragment of HSV-1 glycoprotein G. Mycoplasma pneumoniae P1 BA127VSP1 Mycoplasma pneumoniae, recombinant adhesin protein P

13 Bulk Antigens Antigen Product code Description Parvovirus PepA (VP1 unique) Parvovirus PepB (VP2 C-term) Parvovirus PepC (VP1 N-term) Parvovirus PepD (VP1 C-term) BA122VSVP1A BA122VSVP1B BA122VSVP1C BA122VSVP1D Parvovirus B19, recombinant protein A, VP1 unique region (VP1 aa 1-230). Parvovirus B19, recombinant protein B, VP1/VP2 C-terminal region (VP1 aa ). Parvovirus B19, recombinant protein C, VP1 N-terminal region (VP1 aa 1-486). Parvovirus B19, recombinant protein D, VP1 C-terminal half (VP1 aa ). Parvovirus NS1 BA122VSNS1 Parvovirus B19, recombinant NS1 (nonstructural protein). Parvovirus VP1 BA122VSVP1 Parvovirus B19, recombinant VP1 (full length, linear epitopes, VP1 aa 1-781). Parvovirus VP2 BA122VSVP1E Parvovirus B19, recombinant VP2 (full length, linear epitopes, VP1 aa ). Parvovirus VP2 VLP BA122VSVP2 Parvovirus B19, recombinant VP2 VLPs (VP2 virus like particles, conformational epitopes, VP1 aa )

14 Sera & Plasma Infectious disease state plasma & sera are used as reference standards or as positive and negative controls in diagnostic test systems. Numerous disease state sera are available from following applicable ethical guidelines. Plasma is collected from single donors within a wide collection network. In order to improve product stability and performance plasma is converted into human, defibrinated plasma (serum) by a well-established re-calcification procedure. Continuous screening of new sample material ensures consistent plasma and serum availability and access even to rare disease state material. All plasma is obtained from qualified and registered donors by approved blood centers in the USA and Europe. All material is tested and certified to comply with regulatory requirements (e.g. donor traceability through the blood bank, virus safety testing, etc.). Products Standard volumes are available in 10 ml, 50 ml and bulk volumes larger than 100 ml. Test samples are available in 1 ml sizes. We routinely screen for the following parameters. Please contact us to check current availabilities. Code Name Code Name PLS128A Adenovirus IgA PLS116A Brucella IgA PLS128G Adenovirus IgG PLS116M Brucella IgM PLS132A Aspergillus fumigatus IgA PLS116G Brucella IgG PLS132G Aspergillus fumigatus IgG PLS139A Campylobacter IgA PLS132M Aspergillus fumigatus IgM PLS139M Campylobacter IgM PLS120A Bordetella pertussis IgA PLS139G Campylobacter IgG PLS120G Bordetella pertussis IgG PLS117A Candida albicans IgA PLS1201A Bordetella pertussis Toxin IgA PLS117M Candida albicans IgM PLS1201G Bordetella pertussis Toxin IgG PLS117G Candida albicans IgG PLS121G Borrelia IgG PLS1371A Chlamydia pneumoniae IgA PLS121M Borrelia IgM PLS1371M Chlamydia pneumoniae IgM Selected negative sera for common IgG s (e. g. CMV, HSV, Measles etc.) are available upon request

15 We routinely screen for the following parameters. Please contact us to check current availabilities. Code Name Code Name PLS1371G Chlamydia pneumoniae IgG PLS133A Enterovirus IgA PLS1372A Chlamydia trachomatis IgA PLS133M Enterovirus IgM PLS1372M Chlamydia trachomatis. IgM PLS133G Enterovirus IgG PLS1372G Chlamydia trachomatis IgG PLS142M Francisella IgM PLS109A CMV IgA PLS142G Francisella IgG PLS109M CMV IgM PLS112M TBE IgM Sera & Plasma PLS109G CMV IgG PLS112G TBE IgG PLS1311A Coxiella phase I IgA PLS145M Hantavirus puumala IgM PLS1311G Coxiella phase I IgG PLS145G Hantavirus puumala IgG PLS131M Coxiella phase II IgM PLS118A Helicobacter pylori IgA PLS1312G Coxiella phase II IgG PLS118M Helicobacter pylori IgM PLS1363A EBV EA IgA PLS118G Helicobacter pylori IgG PLS1363M EBV EA IgM PLS1051M HSV-1 IgM PLS1363G EBV EA IgG PLS1051G HSV-1 IgG PLS1362M EBV EBNA1 IgM PLS1052A HSV-2 IgA PLS1362G EBV EBNA1 IgG PLS1052M HSV-2 IgM PLS1361A EBV VCA IgA PLS1052G HSV-2 IgG PLS1361M EBV VCA IgM PLS105A HSV 1/2 IgA PLS1361G EBV VCA IgG PLS105G HSV 1/2 IgG PLS107G Echinococcus ssp. IgG PLS106A Legionella pneumophila IgA

16 Sera & Plasma Products Standard volumes are available in 10 ml, 50 ml and bulk volumes larger than 100 ml. Test samples are available in 1 ml sizes. We routinely screen for the following parameters. Please contact us to check current availabilities. Code Name Code Name PLS106M Legionella pneumophila IgM PLS122M Parvovirus B19 IgM PLS106G Legionella pneumophila IgG PLS129M Rubella IgM PLS125M Leptospira ssp. IgM PLS129G Rubella IgG PLS125G Leptospira ssp. IgG PLS113A RSV IgA PLS147G Leishmania IgG PLS113G RSV IgG PLS102M Measles IgM PLS110A Toxoplasma gondii IgA PLS102G Measles IgG PLS110M Toxoplasma gondii IgM PLS103M Mumps IgM PLS110G Toxoplasma gondii IgG PLS103G Mumps IgG PLS104A VZV IgA PLS127A Mycoplasma pneumoniae IgA PLS104M VZV IgM PLS127M Mycoplasma pneumoniae IgM PLS104G VZV IgG PLS127G Mycoplasma pneumoniae IgG PLS138A Yersinia enterocolitica IgA PLS122G Parvovirus B19 IgG PLS138M Yersinia enterocolitica IgM PLS122M Parvovirus B19 IgM PLS138G Yersinia enterocolitica IgG Selected negative sera for common IgG s (e. g. CMV, HSV, Measles etc.) are available upon request

17 Key Applications:» Reference standard» Positive control» Negative control Benefits:» Constant availability» Broad portfolio»»» Bulk availability» Local European distribution Improved stability (defibrinated Human Plasma) Standardized packaging (10 & 50 ml) Sera & Plasma For orders in Germany, Austria and Switzerland, please contact our sales partner: Agnes Connerth The Binding Site GmbH Robert-Bosch-Str. 2A Schwetzingen, Germany Phone: Fax: office@bindingsite.de Internet:

18 Bovine Serum Albumin Improve your kits... Bovine serum albumin (BSA) is a globular serum protein (~66.5 kda). Due to its high stability and lack of interference in many biological reactions, BSA is widely used in diagnostic test systems. Typical applications include use as protein calibrator, stabilizer and blocking agent. BSA is often referred to as Fraction V based on the original fractionation of human plasma developed by Edwin Cohn. Primarily developed for human albumin production the process was later adapted to Bovine Serum Albumin. In modern manufacturing processes, Cohn fractionation is now replaced by a modified, more effective heat shock method resulting in BSA of significantly higher degree of purity (> 98 %). now offers a variety of BSA products to cover the needs of the diagnostic industry. All bovine products are sourced from controlled abattoirs and are manufactured in the USA. All animals receive ante- and post-mortem inspections in order to meet regulatory requirements and are classified as free from infectious diseases and parasites. Products Description Product Quantity Bovine Serum Albumin, Standard grade, USA origin Bovine Serum Albumin, Protease free, USA origin Bovine Serum Albumin, Fatty Acid free, USA origin Bovine Serum Albumin, Sulfhydryl blocked, USA origin Bovine Serum Albumin, 30 % Solution, with 0,1 % Soduim azide, USA origin BSA-0010SG BSA-0100SG BSA-1000SG BSA-0010PF BSA-0100PF BSA-1000PF BSA-0010FF BSA-0100FF BSA-1000FF BSA-0010SH BSA-0100SH BSA-1000SH BSA-001SL BSA-010SL 10 g 100 g g 10 g 100 g g 10 g 100 g g 10 g 100 g g 1 L 10 L

19 Key Applications:» Protein calibration, diluent & control» Electrophoresis standard» ELISA blocking reagent» Protein stabilizer» Surface coating Benefits:» Highest purity»» Minimal IgG content»» ph Treatment (viral inactivation)» 0,2 µm Filtration» Full documentation Minimal enzymatic and protease activities C Heat treatment (viral inactivation) Bovine Serum Albumin

20 Service ELISA Coating Fully automated ELISA production line including coating, incubation, and vacuum packing. A modular and extendable system enables processing up to four different lots with individual requirements in one production flow. Our all-inclusive service is ready for your batch production. Lyophilization A gentle lyophilization procedure for saline based buffer and protein containing solutions. Batch sizes up to several thousand vials can be freeze dried under gentle and continuously monitored conditions. Features - Feasibility check - Technical support - ISO approved environment - Fast order & production processes - Highest quality - Full documentation Benefits - Extended shelf life - Increased stability - Reduced weight & volumes - Increased storage capacities - Reduced packaging volumes - Reduced shipment costs

21 Contact If you have any questions or to place an order please contact us: Alexandra Beck Customer Service Phone: Fax: Stefan Papadileris Sales Manager Mobile: Phone: Fax: Dr. Thomas Schumacher Business Unit Manager Mobile: Phone: Fax: Service

22 Terms and conditions Delivery conditions: Products from Institut Virion\Serion GmbH will, in the absence of any other written agreement, be delivered according to the following conditions. On issuing an order, the buyer agrees to accept the delivery conditions. Institut Virion\Serion GmbH does not accept any conditions imposed by the purchaser, this applies also when Institut Virion\Serion GmbH has not expressly rejected such conditions. Contract terms are valid for all future business transactions without having to be reiterated. Orders: Orders to Institut Virion\Serion GmbH can be made in writing (including electronic communication) or verbally. Verbally issued orders first become legally binding for Institut Virion\Serion GmbH on receipt of written confirmation from the purchaser or on delivery of goods. Delivery: Institut Virion\Serion GmbH generally deliver to end users within 7 days of order receipt and to distributors within 14 days, but does not warrant that a particular delivery date will be met. If a delivery is not possible through unforseeable circumstances (e.g., factory disruptions, raw material delivery delays, transport difficulties), there is no obligation to supply. Institut Virion\Serion GmbH reserve the right to make partial deliveries. Institut Virion\Serion GmbH reserves the right to refuse to deliver products if any payment due in respect of products previously delivered remains outstanding. Institut Virion\Serion GmbH reserves the right to determine the packing and dispatching method at its own discretion, according to the prevailing requirements. Product characteristics: The delivered products comply with specifications given in the product catalogue, on the product itself, or in the supplied information sheets. If specifications are inconsistent, the labels on the product itself and the details in the information sheet provided with the product apply. After the given expiration date has passed, the products must not be used. The products of Institut Virion\Serion GmbH must only be used for the intended use stated. It is the buyer s responsibility to check the functional capability immediately on receipt of the product as well as on every day of usage. In particular, the functioning of test reagents can be perturbed through causes outside the direct influence of the manufacturer, for example, through suboptimal transportation, incorrect storage, or incorrect usage. Institut Virion\Serion GmbH products are supplied for professional use and the competence of the end user is assumed. Warranty and liability: In the absence of any other written agreement, all risks pass to the buyer as soon as the goods have been delivered to the carrier or have left Institut Virion\Serion GmbH for dispatch. In the event that delivery is postponed or delayed by request of the buyer, product liability passes to the buyer upon notification by Institut Virion\ Serion GmbH that the products are ready for dispatch. On receipt of the goods, the buyer has one working day to check that they are in accordance with the nature and quantity of the agreement, and that the goods are free from perceivable defects. If any complaints arise from this inspection, they should be communicated to Institut Virion\Serion GmbH in writing within 2 working days. Hidden defects or functional faults that were not identifiable by the initial inspection and are later discovered, e.g. when using, should be communicated to Institut Virion\Serion GmbH in writing within 14 days. If no complaints are received within the stipulated period, it is assumed that the goods are of appropriate quality and quantity for the customer. Complaints do not release the buyer from payment obligation. In the case of prompt and founded complaints on the grounds of product defects or the delivery of product other than ordered, Institut Virion\ Serion GmbH is obliged to exchange or amend the goods within 14 days or to withdraw or reimburse the payment, as it chooses. If the defect is not corrected in spite of delivery of a replacement or an amended product, the buyer can demand that the sale is cancelled. In the case of product quantity promptly notified, Institut Virion\Serion GmbH has the choice between a further delivery or an appropriate credit note. Further compensatory claims from the buyer are excluded, as long as Institut Virion\Serion GmbH and Serion Immundiagnostica GmbH have not violated its contractual or legal obligations through outright negligence or by intention. Institut Virion\Serion GmbH and Serion Immundiagnostica GmbH take no responsibility for consequential harm resulting from faulty goods

23 Prices: Prices from the official Institut Virion\Serion GmbH pricelist in the country of the buyer are applicable. Invoices are provided in the agreed currency. Prices are ex works. Additional expenses for packing and freight as well as for cooling during transport are added on. Statutory value added tax is not included in the list prices. Payment terms: Payment obligations in countries of export must be settled within 30 days after receipt of goods. No discounts will be given unless agreed in writing. Payments by cash transfer or check are valid from the time that the invoiced amount is credited to an Institut Virion\ Serion GmbH bank account. In cases of payment arrears, Institut Virion\Serion GmbH reserve the right to charge a compensatory interest of 10 % p.a., applicable from the settlement date, without any further notice. In special cases Institut Virion\Serion GmbH can arrange alternative payment periods or require advance payments. Payments outstanding to Institut Virion\Serion GmbH resulting from an order cannot be offset by the customer through counter demands. Ownership rights: The delivered goods remain the property of Institut Virion\Serion GmbH until full payment has been made. Selling on of Institut Virion\Serion GmbH products is only permitted for companies who are authorised in writing from Institut Virion\Serion GmbH to do so. Confidential information received from Institut Virion\Serion GmbH should not be passed on to third parties without written permission from Institut Virion\Serion GmbH. Consultation: Advice from Institut Virion\Serion GmbH, although provided to the best knowledge, is nevertheless not binding. No liability claims can ensue from erroneous advice. Applicable law, place of jurisdiction, ineffective regulations: The contract conditions are subject to the laws of the Federal Republic of Germany. The United Nations Conventions on Contracts for the International Sale of Goods does not apply. The place of jurisdiction is Würzburg, in so far as no other place has been agreed in writing. Friedrich-Bergius-Ring 19 D Würzburg, Germany Phone: Fax: info@serion-immunologics Internet:

24 your partner in ANTIGEN sourcing V 1.14/10, Friedrich-Bergius-Ring 19, D Würzburg, Germany Phone: , Fax: info@serion-immunologics.com, Internet: