Product Catalogue Clinical Diagnostics

Transcription

1 R-Biopharm AG Product Catalogue Clinical Diagnostics 2011/ 2012

2 R-Biopharm AG Product Catalogue 2011/2012 2

3 Introduction Editorial Page 4 Overview of R-Biopharm test systems Page 6 Allergy Diagnostics Introduction Page 8 Products Page 9 Infectious Diseases / Antigen Detection Introduction Page 12 Products Page Infectious Diseases / Antibody Detection Introduction Page 16 Products Page Molecular Diagnostics Introduction Page 22 Products Page 23 Tumor Diagnostics Introduction Page 24 Products Page 25 Gastroenterology Introduction Page 26 Products Page 27 Instruments / Software / Accessories Introduction Page 28 Products Page 29 Vitamin Detection Page 29 R-Biopharm Contacts Page 31 General Terms of Sale and Delivery of R-Biopharm AG Page 33 3

4 R-Biopharm AG Comprehensive solutions from a single source reliable, tried and tested R-Biopharm is a leading developer of test solutions for Clinical Diagnostics and Food & Feed Analysis. In both sectors, the R-Biopharm test kits offer high precision and accuracy, key requirements where patient and consumer health is at risk. R-Biopharm s future projects will offer further exciting prospects in the fields of Clinical Diagnostics and Food- & Feed Analysis. The foremost challenge is to advance the development of new and versatile fast tests. These will shorten the time it takes to obtain results from a wide range of analytical procedures. Awards R-Biopharm has earned numerous awards for its business performance. In 2004 the company achieved a double success, being nominated as a finalist for Entrepreneur of the Year 2004, 2005 and 2006 as well as it was placed in 2004 and 2005 in the Technology Fast 50, a ranking of Germany s 50 fastest-growing technology companies. R-Biopharm worldwide Today the German parent company R-Biopharm AG is represented by subsidiaries in the UK, USA, Italy, France, Latin America, Brazil, China, Spain and Australia as well as by a worldwide extensive network of more than 80 distributors. In addition, Switzerland, Austria, and the Netherlands are represented by local Country Managers. R-Biopharm AG Product Catalogue 2011/2012 4

5 R-Biopharm History and Milestones employees 1988 Foundation by Röhm GmbH Darmstadt, Germany First products on the market 9 Distribution by Riedel de Haën 1991 Management Buy Out by Dr. Ralf M. Dreher Own distribution of Agri-Diagnostics Start distribution Clinical Diagnostics ISO 9001 and DIN EN Foundation R-Biopharm Inc. USA Merger with Innova Labordiagostik GmbH Worldwide exclusive distribution rights for the Enzymatic 91 Testkits of Roche Diagnostics 2001 Acquisition (90%) of Rhône Diagnostics Technologies Ltd Foundation of R-Biopharm Italia Srl Move to new facilities (Landwehrstraße, Darmstadt) Foundation of R-Biopharm China Foundation of R-Biopharm LA and R-Biopharm Brasil Ltda Foundation of R-Biopharm Espana S.A. and R-Biopharm Australia Move to new facilities (An der neuen Bergstraße, Darmstadt) Aquisition of Trilogy Analytical Laboratory Inc. (USA) and RefLab (Denmark) 350 R-Biopharm AG Headquarters Darmstadt 5

6 An overview of R-Biopharm test systems The products of both departments, Clinical Diagnostics as well as Food & Feed Analysis, have been designed and developed primarily for the immunoassay platform. Nonetheless, today there is also a great demand for other test formats like lateral flow tests, immunoblots, immunofluorescence assays, PCR or card tests. RIDASCREEN, RIDA and PentoCheck are world-wide registered trademarks of R-Biopharm AG. In Clinical Diagnostics R-Biopharm possesses many years of sound experience, particularly in the field of infectiological stool diagnostics but also in the field of serological infection diagnostics and allergy diagnostics. In 2006 the clinical product portfolio was extended by innovative test systems in the product lines tumor diagnostics and gastroenterology. R-Biopharm AG has been a successful market player worldwide and is constantly developing new and partly groundbreaking test systems in different areas. In this process automation is a main focus from the beginning. All R-Biopharm tests are validated and CE-marked. All products are not intended for use in diagnostic procedure in the US, except products marked FDA-cleared. R-Biopharm AG Product Catalogue 2011/2012 6

7 RIDASCREEN ELISA for antigen and antibody detection Ready-to-use reagents Simple realization of tests Standardized incubation period Possibility of processing on automated ELISA-systems Evaluation by the software RIDA SOFT Win RIDA QUICK Reliable rapid test for antigen detection High sensitivity and specificity Agents distinguished by color 2 test formats: dipstick cassette RIDA FLUOR Immunofluorescence assays for antibody detection (IgG and IgM) in serum Immunofluorescence assays for the quality assurance (mycoplasma) out of the cell culture Test set consisting of microslides, controls and reagents RIDA PentoCheck Highly specific primary mouse antibody Directed against human transketolase-like 1 for immunohistochemistry protein (TKTL1) RIDA BLOT and RIDA LINE Western blots and Line blots for antibody detection Usage for the confirmation of positive results or in case of unclear findings by other serological methods Immunoblot (RIDA AllergyScreen) for specific antibody detection (IgE) in serum RIDA GENE real-time PCR contains all necessary components high sensitivity and specificity can be run on the commonly used real-time PCR instruments 7

8 Allergy Diagnostics Allergen specific laboratory studies are absolutely essential for allergy diagnostics. The allergy diagnostics of R-Biopharm offers two test methods for the antibody detection, the enzyme immunoassay and an immunoblot (RIDA AllergyScreen). In additon to the system of the customized plate where the microtiterplates are assembled with allergen discs by R-Biopharm in advance according to the client s order, R-Biopharm offers all allergen discs also inserted in breakable strips. There is a choice to order either different single allergens, which have to be inserted into a microwell frame by breaking the wells from the 8-well strip, according to the patients need, or any selections of 8 different allergens in one 8-well strip (panel) by inserting the complete different panels into the frame. The eight allergens for a panel can be selected from our variety of more than 700 allergens. With the possibility to order different individual panels, the high flexibility of single allergens is combined elegantly with the economic efficiency and the simple handling of the customized plate. For more convenient screening purposes the ready assembled panels Allergytest Atopy, Respiratory, Food and Padiatric can be used. The 16 different allergen discs are inserted in a 16-well block. Every kit consists of 10 blocks including the reagents needed. Panels from different kits (Atopy, Respiratory, Food and/or Pediatric) can be combined in the same frame and performed in the same run. As far as screening is concerned four different panels of RIDA AllergyScreen (panel 1-4) with 20 allergens each are available. With only 250 μl serum per panel 20 allergens can be tested simply and quickly in one work cycle, an efficient and highly economic system for the diagnostic confirmation of allergies. The RIDA AllergyScreen thus yields in a short time a specific patient s sensibilization pattern of the most common allergens. The evaluation of the panels is done either manually by comparing the bands with the color card coming with the kit or automatically by way of digital picture evaluation in the RIDA X-Screen, RIDA quadro-screen or RIDA maxi-screen 2. The connected software analyzes the color intensity of the bands and delivers a specific patient s record (data 6 EAST-classes). Total IgE detection: always in combination with specific IgE as complementary diagnostics of diseases that could be associated with atopy (urticaria, Quincke s disease, unclear exanthema,...) within the scope of the diagnostics referring to further diseases like certain autoimmune diseases, Churg-Strauss-syndrom and lymphoma for the diagnostics and therapy control in the case of parasitosis, unclear blood eosinophilia and negative parasitic findings for the diagnosis of hereditary or acquired immune deficiency Detection of specific IgE: in the case of discrepancy between anamnesis and skin test result for the determination of the sensibility degree to prepare the provocation test for the preparation of immune therapies In the case of certain indications the laboratory study should be done without a previous skin test: with children under six years with patients with low vitality (cardiovascular diseases,...) in the case of suspected extreme sensibility (insect venoms or drugs allergy) with skin mutations in the testing area (neurodermatitis, eczema, urticaria,...) with drug therapy (antihistamines, immunosuppressives,...) in the case of suspected cutaneous sensitization in the case of suspected sensitization of allergens that do not exist as pricktest solutions by the follow-up of an immune therapy The results though may only be interpreted in connection with the anamnesis and the in vivo-testing. R-Biopharm AG Product Catalogue 2011/2012 8

9 Allergy Diagnostics ELISA Product Description Tests Matrix Art. No. RIDASCREEN Allergen Disc incl. reagents for spec. IgE Enzym immunoassays for antibody detection Enzyme immunoassay for the determination of circulating allergen-specific IgE in serum Quantitative determination of specific IgE Positive and negative control 1 A0249 Allergen Disc without reagents 1 A0049 Set of Reagents Specific IgE Set of Reagents Specific IgE incl. standards and controls A0041 incl. standards and controls 192 A0040 Set of standards and controls Total lge Allergen Disc incl. reagents for spec. IgG (spec. IgE) sufficient for 4 approaches in double determination Enzyme immunoassay for the quantitative determination of circulating Immunoglobulin E (Total-IgE) in human serum Enzyme immunoassay for the determination of specific IgG in serum Quantitative determination of specific IgG High and low control A A A0629 Set of Reagents Specific IgG Set of Reagents Specific IgG incl. standards and controls A0021 incl. standards and controls 192 A0020 9

10 Allergy Diagnostics Panel format Product Description Tests Matrix Art. No. Panel format for single allergen discs Allergytest Atopy 10 panels with 16 allergens each, incl. reagents 10 A0251 Allergytest Respiratory 10 panels with 16 allergens each, incl. reagents 10 A0252 Allergytest Food 10 panels with 16 allergens each, incl. reagents 10 A0253 Allergytest Pediatric 10 panels with 16 allergens each, incl. reagents 10 A0254 Allergytest Modular IgE* 10 panels, customized allergen composition, incl. reagents 10 A0250 Allergytest Modular IgG* * minimum order of customized panels is 10 kits 10 panels, customized allergen composition, incl. reagents 10 A0630 R-Biopharm AG Product Catalogue 2011/

11 Allergy Diagnostics Immunoblots Product Description Tests Matrix Art. No. RIDA AllergyScreen Panel 1 (7 food allergens / 13 respiratory allergens) Immunoblots for antibody analysing Immunoblot for semiquantitative determination of circulating allergen-specific Immunoglobulin E (IgE) in human serum Test membranes (nitrocellulose membrane) in reaction troughs 10 A2142 AllergyScreen Panel 2 (20 respiratory allergens) AllergyScreen Panel 3 (20 food allergens) AllergyScreen Panel 4 (20 allergens / paediatric panel) Immunoblot for semiquantitative determination of circulating allergen-specific Immunoglobulin E (IgE) in human serum Test membranes (nitrocellulose membrane) in reaction troughs Immunoblot for semiquantitative determination of circulating allergen-specific Immunoglobulin E (IgE) in human serum Test membranes (nitrocellulose membrane) in reaction troughs Immunoblot for semiquantitative determination of circulating allergen-specific Immunoglobulin E (IgE) in human serum Test membranes (nitrocellulose membrane) in reaction troughs 10 A A A2442 Solution for automatisation available, please ask the local distributor. Accessories for RIDA AllergyScreen and RIDASCREEN Specific IgE, total IgE and Specific IgG see: Instruments / Software / Accessories 11

12 Infectious Diseases / Antigen Detection Infections of the gastrointestinal tract belong to the most common diseases of our modern society. In the industrialized nations they are by now the second frequent disease in childhood. The diagnostics of infectious intestinal diseases belongs to the most frequent requirements in a medical microbiological lab. Knowledge of pathogenesis, epidemiology and diagnostics of these diseases has grown considerably over the last years, along with the list of possible agents. Besides the classical methods of microbiology, immunological tests like ELISA and immunochromatographic rapid tests play an increasingly important role in the microbiological lab. Their advantage over culturing methods is the possibility of detecting also those germs that are no longer able to multiply. Usually, an infection caused by enteropathogenic microorganisms disturbs the normal barrier function of the intestinal mucosa, however normally only temporarily. Such enteropathogenic species are found among bacteria, viruses and protozoans. As far as infants are concerned, Rotaviruses are among the most important causes of infectious enteritis. In addition to Astro- and Adenoviruses, Norovirus in particular plays an important role among those viral agents as it cannot be cultivated. Among the protozoans, Giardia lamblia, Entamoeba histolytica and Cryptosporidia are the most important causative agents of diarrhoea. As far as bacteria are concerned, Campylobacter causes by now just as many diseases as Salmonella, besides a large number of other pathogenic bacteria species. R-Biopharm offers a wide range of test kits for the specific detection of antigens of the different pathogenic agents in stool specimens. The ELISA systems are available under the trade name RIDASCREEN, the immunochromatographic rapid tests under the trade name RIDA QUICK respectively. The rapid tests are offered as dipsticks as well as in the practical cassette format. Available parameters for the detection of: Bacteria and Toxins Parasites Campylobacter Clostridium difficile Toxin A/B Clostridium perfringens Enterotoxin E. coli O157 Verotoxins (Shigatoxins) Cryptosporidium Entamoeba Giardia Viruses Adenovirus Astrovirus Norovirus Rotavirus R-Biopharm AG Product Catalogue 2011/

13 Infectious Diseases / Antigen Detection ELISA Product Description Tests Matrix Art. No. RIDASCREEN Adenovirus Enzym immunoassays for antigen detection Enzyme immunoassay for the detection of Adenoviruses stool C1001 Astrovirus Campylobacter Clostridium difficile Toxin A/B Clostridium perfringens Enterotoxin Cryptosporidium Entamoeba Giardia Enzyme immunoassay for the detection of Astroviruses Enzyme immunoassay for the detection of Campylobacter Enzyme immunoassay for the detection of the toxins A and B of C. difficile Enzyme immunoassay for detection of enterotoxin of C. perfringens Enzyme immunoassay for the detection of Cryptosporidium parvum Enzyme immunoassay for the detection of Entamoeba histolytica/dispar Enzyme immunoassay for the detection of Giardia lamblia stool C1301 stool C2401 stool C0801 stool C0601 stool C1201 stool C1701 stool C1101 Norovirus Enzyme immunoassay for the detection of Noroviruses stool stool C1401 C1401US* FDA cleared Rotavirus Enzyme immunoassay for the detection of Rotaviruses stool C0901 Verotoxin Enzyme immunoassay for the detection of verotoxins 1 and 2 (Shigatoxins 1 and 2) of E. coli bacteria stool mtsb C2201 RIDA Enrichment broth mtsb-bouillon with Mitomycin C for the enrichment of verotoxin (shigatoxin)-producing E. coli bacteria Z1000 Z1003 * Only for sale in the US 13

14 Infectious Diseases / Antigen Detection Rapid Product Description Tests Matrix Art. No. RIDA QUICK Clostridium difficile Toxin A/B Rapid assays for antigen detection Single pouched cassettes 25 stool N0803 Cryptosporidium Box with strips Immunochromatographic rapid assay for the detection of Cryptosporidium parvum 25 stool N1202 Cryptosporidium Single pouched cassettes 20 stool N1203 Cryptosporidium/ Giardia Combi Box with strips Immunochromatographic rapid assay for the detection of Cryptosporidium parvum and/or Giardia lamblia 25 stool N1122 Cryptosporidium/ Giardia Combi Single pouched cassettes 20 stool N1123 Cryptosporidium/ Giardia/Entamoeba Combi Box with strips Immunochromatographic rapid assay for the detection of Cryptosporidium and/or Giardia and/or Entamoeba 25 stool N1722 Cryptosporidium/ Giardia/Entamoeba Combi Single pouched cassettes 20 stool N1723 Entamoeba Box with strips Immunochromatographic rapid assay for the detection of Entamoeba histolytica/dispar 25 stool N1702 Entamoeba Single pouched cassettes 20 stool N1703 Giardia Box with strips Immunochromatographic rapid assay for the detection of Giardia lamblia 25 stool N1102 Giardia Single pouched cassettes 20 stool N1103 Norovirus Rotavirus Single pouched cassettes Immunochromatographic rapid assay for the detection of Noroviruses Box with strips Immunochromatographic rapid assay for the detection of Rotaviruses 20 stool N stool N0902 Rotavirus Single pouched cassettes 20 stool N0903 Rotavirus/Adenovirus Combi Box with strips Immunochromatographic rapid assay for the detection of Rotaviruses and/or Adenoviruses 25 stool N1002 Rotavirus/Adenovirus Combi Single pouched cassettes 20 stool N1003 Verotoxin/0157 Combi Box with strips Immunochromatographic rapid assay for the detection of verotoxins and/or E. coli O mtsb Bouillon N2202 Verotoxin/0157 Combi Single pouched cassettes 20 mtsb Bouillon N2203 RIDA Enrichment broth mtsb-bouillon with Mitomycin C for the enrichment of verotoxin (shigatoxin)-producing E. coli bacteria 25 Z1003 R-Biopharm AG Product Catalogue 2011/

15 Infectious Diseases / Antigen Detection Controls Product Description Tests Matrix Art. No. Clostridium difficile Toxin A/B Controls for RIDA QUICK Rapid assays Positive control 1.8 ml NP0804 Norovirus Positive control 1.8 ml NP1404 Parasite Combi Control Rotavirus/Adenovirus Combi Control Verotoxin/O157 Combi Control Positive control 1.8 ml NP1704 Positive control 1.8 ml NP1904 Positive control 1.8 ml NP2204 Accessories for RIDASCREEN and RIDA Antigen Detection tests see: Instruments / Software / Accessories 15

16 Infectious Diseases / Antibody Detection Requirements for the modern serological diagnostics. The R-Biopharm test systems for infectious diseases cover all important areas of modern serological diagnostics. All test kits are highly specific and sensitive for the respective pathogens. New: All RIDASCREEN Sero ELISA test kits contain two additional controls for quality assurance purposes. RIDASCREEN Sero ELISA: Individual patient analysis leads to multiple determinations which must be tested in parallel. Test specific reagents and different incubation times require an amount of time and work that can hardly be handled. In our RIDASCREEN Sero ELISA product group the number of reagents is reduced to a minimum by offering common buffers and conjugates. Identical incubation times also make the simultaneous analysis of different RIDASCREEN ELISA for parasite diagnostics: R-Biopharm offers six ELISAs for the most important serological parameters in parasitology. To ensure quality of antibody detection in parasite diagnostics the selection of appropriate antigens is crucial. tests easier. Thus RIDASCREEN Sero ELISA fulfil the essential requirements for an automatic processing on modern ELISA systems that help to facilitate procedures in the laboratory. A single-point calibration of the standard curve reduces the number of standards to a single one and therefore keeps costs to the minimum. Interpretation of results is quick and easy by using RIDA SOFT Win software. In addition to the RIDASCREEN Sero ELISA product line R-Biopharm offers two more groups for infectious serological diagnostics: RIDASCREEN ELISA for Chlamydia diagnostics: Identification of species-specific antibodies is the decisive factor in the diagnosis of Chlamydia. The high crossreactivity of most antigens poses an immense problem for this diagnostic test. Only certain components of the outer membrane protein complex allow the separate identification of antigens against C. trachomatis and C. pneumoniae. By using these proteins in the RIDASCREEN ELISA we offer two highly specific tests for Chlamydia diagnostics. Common reagents and incubation times allow simultaneous analysis of these parameters that are of high importance for infectious serology. For this reason we place a special focus on the selections of antigens used in our RIDASCREEN ELISA for parasite diagnostics. Also in this product line all test share common buffers and incubation times. Enzyme immunoassays for the detection of: Respiratory tract infections: Adenovirus, Bordetella, Chlamydophila pneumoniae, EBV (VCA, EBNA), Influenza A, Influenza B, Influenza A/B, Mycoplasma pneumoniae, Parainfluenza 1 2 3, RSV Parasitic infections: Entamoeba histolytica, Taenia solium (cysticercosis), Echinococcus, Leishmania, Toxocara, Trichinella Herpes virus infections: EBV (VCA, EBNA), HSV 1, HSV 2, HSV 1+2, VZV Child diseases: Bordetella, Measles virus, Mumps virus, Parvovirus B19, VZV Sexually transmitted diseases: Chlamydia trachomatis, HSV 1, HSV 2, HSV 1+2 Grave infections in pregnancy: HSV 1, HSV 2, HSV 1+2, Parvovirus B19, VZV Zoonosis: Borrelia burgdorferi, Taenia solium (cysticercosis), Echinococcus, Leishmania, Toxocara, Trichinella Gastrointestinal infections: Helicobacter pylori, Entamoeba histolytica Vaccination control: Diphtheria, Tetanus, VZV Fungal infection: Candida albicans R-Biopharm AG Product Catalogue 2011/

17 Infectious Diseases / Antibody Detection Sero ELISA New! All RIDASCREEN Sero ELISA test kits contain two additional controls for quality assurance purposes Product Description Tests Matrix Art. No. RIDASCREEN Adenovirus lga Adenovirus lgg Enzyme immunoassays for antibody detection Enzyme immunoassays for specific detection of IgA or IgG antibodies against Adenoviruses The test can be used for the detection of antibodies against the different subtypes K1011 K1021 Bordetella lga Bordetella lgg Bordetella lgm Enzyme immunoassays for specific detection of IgA, IgG or IgM antibodies against Bordetella pertussis and parapertussis Differentiation between infections and immune status after vaccination K2511 K2521 K2531 Borrelia lgg Borrelia lgm Enzyme immunoassays for specific detection of IgG or IgM antibodies against Borrelia burgdorferi sensu lato K3221 K3231 Borrelia Liquor IgG Borrelia Liquor IgM Set of reagents (without microplate) as supplement to test kits K3221 and K3231 For investigation of serum/csf pairs CSF CSF KLiq3221 KLiq3231 Candida lga Candida lgg Candida lgm Enzyme immunoassays for specific detection of IgA, IgG or IgM antibodies against Candida albicans and other antigenetically related Candida species K9011 K9021 K9031 Diphtherie lgg EBV EBNA lgg Enzyme immunoassay for specific detection of IgG antibodies against the diphtheria toxoid Differentiation between infections and immune status after vaccination Analysis in international units (IU/ml) Enzyme immunoassay for specific detection of IgG antibodies against the Epstein-Barr-Virus nuclear antigen (EBNA) of Epstein-Barr-Virus (EBV) Documentation of the transition to the state of latency under use of EBNA-1 K3821 K6621 EBV VCA lgg EBV VCA lgm Enzyme immunoassays for specific detection of IgG or IgM antibodies against structure proteins (VCA = virus capsid antigen) of the Epstein-Barr- Virus (EBV) K6721 K6731 Helicobacter lga Helicobacter lgg Enzyme immunoassays for specific detection of IgA or IgG antibodies against Helicobacter pylori K2311 K2321 HSV 1 lgg (glycoprotein G1) HSV 1 lgm (total antigen) HSV 2 lgg (glycoprotein G2) HSV 2 lgm (total antigen) Enzyme immunoassays for type-specific detection of IgG antibodies against the Herpes-Simplex- Viruses (HSV) by use of glycoprotein G (gg) Recombinant gg1 of HSV 1 and purified gg2 of HSV 2 Differentiation between a primary infection (IgG antibody negative) and a recurrence (IgG antibody positive) K5121 K5131 K5221 K5231 HSV 1+2 lgg (total antigen) HSV 1+2 lgm (total antigen) Screening tests for specific detection of IgG or IgM antibodies against Herpes-Simplex-Viruses type 1 and type 2 (HSV 1, HSV 2) K5021 K5031 Influenza A lga Influenza A lgg Influenza B lga Influenza B lgg Enzyme immunoassays for specific detection of IgA or IgG antibodies against Influenza viruses of type A or B K6311 K6321 K6411 K

18 Infectious Diseases / Antibody Detection Sero ELISA New! All RIDASCREEN Sero ELISA test kits contain two additional controls for quality assurance purposes Product Description Tests Matrix Art. No. RIDASCREEN Masern/Measles Virus lgg Masern/Measles Virus lgm Enzyme immunoassays for antibody detection Enzyme immunoassays for specific detection of IgG or IgM antibodies against measles virus IgG-analysis in international units (IU/ml) K5421 K5431 Mumps Virus lgg Mumps Virus lgm Enzyme immunoassays for specific detection of IgG or IgM antibodies against mumps virus K5521 K5531 Mycoplasma pneumoniae lga Mycoplasma pneumoniae lgg Mycoplasma pneumoniae lgm Enzyme immunoassays for specific detection of IgA, IgG or IgM antibodies against Mycoplasma pneumoniae K4311 K4321 K4331 Parainfluenza 1, 2, 3 lga Parainfluenza 1, 2, 3 lgg Screening test for specific detection of IgA or IgG antibodies against Parainfluenza viruses of type 1, 2 and 3 K5811 K5821 New! Parvovirus B19 lgg Parvovirus B19 lgm Enzyme immunoassays for specific detection of IgG or IgM antibodies against Parvovirus B19 Detection of antibodies against recombinant VP1 and VP2 IgG-analysis in international units (IU/ml) K6021 K6031 RSV lga RSV lgg RSV lgm Enzyme immunoassays for specific detection of IgA, IgG or IgM antibodies against Respiratory Syncytial Virus (RSV) K5911 K5921 K5931 Tetanus lgg Enzyme immunoassay for specific detection of IgG antibodies against the tetanus toxoid Analysis in international units (IU/ml) K3721 VZV lga VZV lgg VZV lgm Enzyme immunoassays for specific detection of IgA, IgG or IgM antibodies against Varicella-Zoster-Virus (VZV) Use of purified glycoprotein for IgG-detection IgG-analysis in international units (IU/ml) K5611 K5621 K5631 R-Biopharm AG Product Catalogue 2011/

19 Infectious Diseases / Antibody Detection Parasite diagnostics Product Description Tests Matrix Art. No. RIDASCREEN Echinococcus lgg Enzyme immunoassays for antibody detection Enzyme immunoassay for specific detection of IgG antibodies against Echinococcus granulosus and Echinococcus multilocularis K7621 Entamoeba histolytica IgG Leishmania Ab Taenia solium lgg Toxocara lgg Trichinella lgg Enzyme immunoassay for specific detection of IgG antibodies against Entamoeba histolytica Enzyme immunoassay for specific detection of IgG antibodies against Leishmania Enzyme immunoassay for specific detection of IgG antibodies against the larval forms of Taenia solium (cysticercosis) Enzyme immunoassay for specific detection of IgG antibodies against Toxocara canis Enzyme immunoassay for specific detection of IgG antibodies against Trichinella spiralis K1721 K7121 K7721 K7421 K7521 Please contact R-Biopharm AG for automatic solutions Chlamydia diagnostics RIDASCREEN Chlamydia IgG/IgM Enzyme immunoassays for antibody detection Enzyme immunoassay for specific detection of IgG or IgM antibodies against LPS antigen (LPS = lipopolysaccharide) of Chlamydia KGM3101 Chlamydia trachomatis IgA Chlamydia trachomatis IgG/IgM Enzyme immunoassay for specific detection of IgA, IgG or IgM antibodies against outer membrane protein complex (COMP = Complexes of Outer Membrane Proteins) of Chlamydia trachomatis K2911 KGM2901 Chlamydophila pneumoniae lga Chlamydophila pneumoniae lgg Chlamydophila pneumoniae lgm Enzyme immunoassays for specific detection of IgA, IgG or IgM antibodies against outer membrane protein complex (COMP = Complexes of Outer Membrane Proteins) of Chlamydophila pneumoniae K2811 K2821 K2831 Please contact R-Biopharm AG for automatic solutions 19

20 Infectious Diseases / Antibody Detection Western blots and Line blots for specific antibody detection Product Description Tests Matrix Art. No. RIDA BLOT and RIDA LINE Western blots and Line blots Helicobacter lga Helicobacter lgg Western blots for specific detection of IgA or IgG antibodies against Helicobacter pylori Differentiation between Helicobacter pylori type I and II L2313 L2323 Parvovirus B19 lgg/lgm Western blot for specific detection of IgG or IgM antibodies against Parvovirus B19 with procaryotic recombinant antigens Western blots allow differentiation between acute and past infection with Parvovirus B19 Indicative for a probably persistent Parvovirus B19 infection 20 L6003 Parvovirus B19 lgg Parvovirus B19 lgm Line blots for specific detection of IgG or IgM antibodies against Parvovirus B19 with procaryotic and eucaryotic recombinant antigens World-wide distributed, except for USA, Canada, Australia and Israel Line blots allow differentiation between acute and past infection with Parvovirus B19 Indicative for a probably persistent Parvovirus B19 infection LB6023 LB6033 Aviditätsreagenz for avidity testing in Line blots 25 LB0023 R-Biopharm AG Product Catalogue 2011/

21 Infectious Diseases / Antibody Detection Immunofluorescence assays for antibody detection Product Description Tests Matrix Art. No. RIDA FLUOR Borrelia burgdorferi sensu lato lgg Borrelia burgdorferi sensu lato lgm Immunofluorescence assays Immunofluorescence assays for antibody detection (IgG, IgM) against Borrelia burgdorferi sensu lato (B. burgdorferi s.l.) Mix of B. burgdorferi s.s., B. garinii, B. afzelii 10 x x 10 I3621 I3631 Legionella lgg (3 Pools) Row 1: SG 1-6 Row 2: SG 7-14 Row 3: L. boz-dum-gor-jord-longb-mic Immunofluorescence assay for detection of IgG antibodies against Legionella pneumophila serogroup 1-14 and six non-pneumophila species of Legionella Slides for immunofluorescence assays 10 x 15 I8520 Borrelia burgdorferi sensu lato Slides Mix of B. burgdorferi s.s., B. garinii, B. afzelii 10 x 10 I3608 Legionella IgG Slides (3 Pools) Row 1: SG 1-6 Row 2: SG 7-14 Row 3: L. boz-dum-gor-jord-longb-mic Controls for immunofluorescence assays 10 x 15 I8529 Negativkontrolle Negative control 0.5 ml I0005 Borrelia burgdorferi Positivkontrolle IgG Borrelia burgdorferi Positivkontrolle IgM Legionella Positivkontrolle IgG Positive control lgg 0.5 ml I3224 Positive control lgm 0.5 ml I3234 Positive control lgg 0.5 ml I8524 Reagents for immunofluorescence assays FITC-Conjugate lgg anti-human IgG FITC-conjugate 2.5 ml I0026 FITC-Conjugate lgm anti-human IgM FITC-conjugate 2.5 ml I0036 Mounting fluid 2.5 ml I0000 Washing/Dilution buffer 50 ml I0001 Immunofluorescence assays for Quality Assurance Mycoplasma IFA Genus specific immunofluorescence assay for the detection of mycoplasma contamination of cell cultures Cell culture Cell culture B4202 B4203 Accessories for RIDASCREEN and RIDA Antibody Detection tests RF-Absorbens Anti-human IgG for absorption of rheumatoid factors (RF) and IgG antibodies in human serum or plasma 50 Z0202 Accessories for RIDASCREEN and RIDA Antibody Detection tests see: Instruments / Software / Accessories 21

22 Molecular Diagnostics Molecular detection methods have revolutionized medical diagnosis and are an essential part of today's laboratory diagnostics. In many areas of infectious diseases the classical detection methods have been replaced or supplemented by polymerase chain reaction (PCR) assays. The earlier a disease is discovered and diagnosed, the better it can be treated. Molecular diagnostics allow for an early and specific diagnosis by direct detection of DNA or RNA of the pathogen thus leading to a selective and therapeutic treatment of the individual patient. R-Biopharm RIDA GENE-kits are based on real-time PCR technology for detection of enteropathogenic viruses and bacteria in fecal samples. These highly sensitive and specific method provides rapid results. A variety of commercial manual or automated extraction systems can be used to obtain the DNA or RNA of the pathogen from stool samples. RIDA GENE kits are available in different versions that can be run on commonly used real-time PCR instruments, such as LightCycler, SmartCycler or ABI series. This allows for a flexible use of the RIDA GENE kits for routine diagnostics. R-Biopharm RIDA GENE kits include all necessary components required for the specific detection of enteropathogenic pathogens. An included internal amplification control detects potential PCR inhibition and ensures reliable results. All R-Biopharm RIDA GENE kits are CE marked and are regularly evaluated by participation in the QCMD (Quality Control for Molecular Diagnostics) quality assessment. Real-time PCR instrument Clostridium difficile & Toxin A/B LC CD Screen LC CD Toxin A/B LC Norovirus LC Clostridium difficile & Toxin A/B V CD Screen V CD Toxin A/B V Norovirus V Norovirus I & II Rotavirus/ Adenovirus Duplex Norovirus I & II LC2.0 RIDA GENE Clostridium difficile HyperTox EHEC/EPEC STEC EAEC Roche LightCyler 1.5 LightCyler LightCyler Cepheid SmartCycler Applied ABI 7000 Biosystems ABI 7300 ABI 7500 ABI 7700 ABI 7900 HT StepOne Abbott m2000rt Stratagene Mx3000P MX3005P Qiagen Rotor-Gene Q 1 RIDA GENE IAC Plus Accessory reagent required (except for Clostridium difficile & Toxin A/B LC, CD Screen LC, CD Toxin A/B LC) 2 RIDA GENE Color Compensation Kit I required 3 RIDA GENE Color Compensation Kit II required Advantages of the R-Biopharm RIDA GENE kits: High sensitivity High specificity Contains all necessary components Reliable due to internal amplification control Flexible can be run on commonly used real-time PCR instruments Validated CE marked & QCMD quality assessment participation R-Biopharm AG Product Catalogue 2011/

23 Molecular Diagnostics Product Description Tests Matrix Art. No. RIDA GENE Clostridium difficile & Toxin A/B V Real-time PCR Real-time PCR for the qualitative detection of Clostridium difficile and Clostridium difficile toxin A (tcda) and toxin B (tcdb) genes in human stool samples 2 x 100 stool PG0805V Clostridium difficile & Toxin A/B LC CD Toxin A/B V CD Toxin A/B V Clostridium difficile HyperTox Norovirus V Norovirus LC Norovirus I & II Norovirus I & II LC 2.0 Rotavirus/Adenovirus Duplex Real-time PCR for the qualitative detection of Clostridium difficile and Clostridium difficile toxin A (tcda) and toxin B (tcdb) genes in human stool samples Real-time PCR for the qualitative detection of Clostridium difficile toxin A (tcda) and toxin B (tcdb) genes in human stool samples Real-time PCR for the qualitative detection of Clostridium difficile toxin A (tcda) and toxin B (tcdb) genes in human stool samples Real-time PCR for the direct qualitative detection and differentiation of the hypervirulent Clostridium difficile ribotpye 027 and the 078-like-group in human stool samples Real-time RT-PCR for the direct, qualitative detection of norovirus (genogroup I and II) in human stool samples Real-time RT-PCR for the direct, qualitative detection of norovirus (genogroup I and II) in human stool samples Real-time RT-PCR for the qualitative detection and differentiation of of norovirus genogroup I and norovirus genogroup II in human stool samples Real-time RT-PCR for the direct qualitative detection and differentiation of norovirus genogroup I and genogroup II on the LightCycler 2.0 in human stool samples. Real-time RT-PCR for the qualitative detection and differentiation of rotavirus and adenovirus in human stool samples 2 x 100 stool PG0805LC 100 stool PG0825V 100 stool PG0825LC 50 stool PG stool PG1405V 100 stool PG1405LC 100 stool PG stool PG stool PG0905 EHEC/EPEC Real-time multiplex PCR for the diect qualitative detection and differentiation of EHEC, STEC, EPEC and EIEC/Shigella spp. in human stool samples and cultures. 100 stool cultures PG2205 EAEC Real-time multiplex PCR for the direct qualitative detection of enteroaggreagtive E. coli (EAEC) in human stool samples and cultures. 100 stool cultures PG2215 STEC Real-time multiplex PCR for the direct qualitative detection and differentiation of Shiga-toxin genes (stx1 and stx2) of Shiga-toxin producing E. coli (STEC) in human stool samples and cultures. 100 stool cultures PG

24 Tumor Diagnostics The transformation of normal to cancerous cells is accompanied by changes in metabolism. Malignant cells exhibit increased glucose consumption as well as increased glycolysis compared to normal cells. The observation that glycolysis is preferred also under aerobic conditions was already noticed and published in the 1920s by the German Nobel laureate Otto Warburg and is known as the Warburg effect. The Warburg effect is still a topic of intensive research. The involved scientists hope that they will be able to find new diagnostics and therapeutics to fight cancer. In general cancer patients do not die because of a primary tumor but because of the metabolic consequences of uncontrolled tumor growth and expansion (metastasis). It is of utmost importance to identify these aggressive tumors early and to treat them with specific therapies. Transketolase dependent reactions regulate the non-oxidative part of the pentose-phosphate-pathway (PPP) in glucose metabolism. This pathway generates NADPH and pentose phosphates. The latter are important for nucleic acid metabolism. Recent publications show, that beside the ubiquitous Transketolase (TKT) other Transketolase-like proteins exist. In 19 Coy et al. reported that Transketolase-like 1 (TKTL1) is a Transketolase-like protein with a 38 amino acid deletion compared to TKT. role of TKTL1 in tumor metabolism. Expression studies on transketolase-like-1 show that the protein is found in aggressive tumors of different entities. The detection of TKTL1 is furthermore correlated with poor patient prognosis and metastasis. Furthermore published functional data is available. It has been shown, that the inhibition of TKTL1 expression by RNA interference results in reduced growth of tumor cells, while overexpression of TKTL1 promotes cell proliferation. Latest publications suggest an important role of TKTL1 in the metabolism of tumor cells. TKTL1 can be detected by immunohistochemistry in patient biopsies with RIDA PentoCheck IHC. Since 19 TKTL1 is a matter of active research and many studies appeared on the R-Biopharm AG Product Catalogue 2011/

25 Tumor Diagnostics Primary Antibodies Product Description Tests Matrix Art. No. RIDA PentoCheck RIDA PentoCheck IHC mab JFC12T10 (IgG2b) Primary Antibodies for immunohistochemistry monoclonal mouse antibody for the detection of human transketolase-like 1 protein (TKTL1) 200 µg Tissue Samples T001 RIDA PentoCheck IHC for breast cancer: System for evaluation of TKTL1 staining intensity in micro-array sections (AEC and hematoxylin) Score 0 Score 1 Score 2 Score 3 25

26 Gastroenterology The analysis of stool matrix by using modern stool markers provides numerous information on the gastrointestinal situation of a patient. Until now these possibilities have either not been fully exploited or not been adequately used in routine diagnostics. The significance of the intestine, known to be the organ with the largest physiologically effective surface area, is still completely underestimated with regards to its importance for health in general. In Germany, approximately 73,000 people are diagnosed each year as having bowel cancer. Colonoscopy is still the method of reference used for detecting carcinomas and adenomas. The detection of occult blood in stool samples is a frequently used screening method of detecting bowel cancer in its early stages. The commonly used guaiac tests are based on the pseudo-peroxidase activity of haemoglobin. These tests are highly sensitive to different food compounds and have therefore a limited significance for detecting bowel cancer. Immunological test systems in contrast have a definite advantage by using specific antibodies exclusively directed against human haemoglobin respectively haemoglobin/haptoglobin complex: These tests can recognize human haemoglobin that is one hundred times lower in concentration compared to that in biochemical methods. False positive or false negative results due to interfering food compounds are nearly impossible. More than 300,000 patients are suffering from inflammatory bowel disease (IBD) in Germany. In many cases, chronic inflammatory bowel disease shows symptoms that are very difficult to distinguish from those of irritable bowel syndrome (IBS). The recently developed new Calprotectin assay provided by R-Biopharm AG will further improve diagnosis of CED. Fecal calprotectin measurement provides a reliable differentiation between chronic inflammatory bowel disease and irritable bowel syndrome. In addition to this measurement of fecal calprotectin provides a means of objectively assessing the response to treatment of chronic inflammatory bowel disease and for monitoring these patients during clinical remission to enable the early detection and treatment of relapses of IBD. With RIDASCREEN ELISA tests R-Biopharm AG offers a range of excellent products for comprehensive and improved diagnostics in the field of gastroenterology. RIDASCREEN ELISA tests for specific detection of human haemoglobin and haemo-/haptoglobin complex in colorectal cancer screening (RIDASCREEN Haemoglobin and RIDASCREEN Haemo-/Haptoglobin Complex) changes of permeability in the gastrointestinal mucous membrane in various diseases (RIDASCREEN a 1 -Antitrypsin) insight into the functional status of the gut associated lymphoid tissue (GALT) (RIDASCREEN siga) reliable differentiation between IBD and IBS (RIDASCREEN Calprotectin) R-Biopharm AG Product Catalogue 2011/

27 Gastroenterology ELISA Product Description Tests Matrix Art. No. RIDASCREEN Haemoglobin Enzyme immunoassays Enzyme immunoassay for the detection of haemoglobin stool G09030 Haemo-/Haptoglobin Complex Enzyme immunoassay for the detection of haemoglobin/haptoglobin complex stool G09031 α 1 -Antitrypsin Enzyme immunoassay for the detection of α 1 -Antitrypsin stool G09034 siga Enzyme immunoassay for the detection of secretoric IgA stool G09035 New! Calprotectin Enzyme immunoassay for the detection of calprotectin stool G09036 Accessories Accessories for RIDASCREEN RIDASCREEN stool tubes for collection and preparation of stool samples, only use with RIDASCREEN Haemoglobin G09030 and RIDASCREEN Haemo-/Haptoglobin Complex G GZ3002 also see: Instruments / Software / Accessories 27

28 Instruments / Software / Accessories The majority of ELISA test kits, especially the kits for detection of infectious diseases, are validated for use with most current laboratory instruments. We provide detailed flyers containing all important data for daily laboratory work. Furthermore the application specialists of R-Biopharm will always be at your disposal, answering your questions and finding solutions to your individual problems. Concerning allergy diagnostics we offer tools corresponding perfectly to the use of the RIDA AllergyScreen panels: the RIDA X-Screen, the RIDA quadro-screen, the RIDA maxi-screen 2 and the ScreenShaker. The shaker is optimized for the incubation of the RIDA AllergyScreen membranes. The measuring tools RIDA X-Screen, RIDA quadro-screen and RIDA maxi-screen 2 combined with the corresponding evaluation software make a fast and precise evaluation possible. R-Biopharm AG Product Catalogue 2011/

29 Instruments / Software / Accessories Accessories Product Description Tests Matrix Art. No. Accessories PE-Pipets One way pipets for stool dilutions 500 Z0001 Stool collectors Paper collection strips for easy and clean stool sampling 100 Z3002 Instruments / Software Instruments Gemini Fully automated 2-plate ELISA processor on request RIDA X-Screen RIDA quadro-screen RIDA maxi-screen 2 ScreenShaker Incubation Box RIDA SOFT Win A.M. Sys Instrument for single measurement and evaluation of RIDA AllergyScreen Panels including software for documentation/archiving Instrument for measurement and semiautomatic evaluation/documentation of 4 RIDA AllergyScreen Panels in parallel Instrument for measurement and semiautomatic evaluation/documentation of 36 RIDA AllergyScreen Panels in parallel Software Software for measurement, evaluation and documentation of RIDASCREEN ELISA tests Allergy Management System; software for management of the allergen database, the patient database and for measurement, evaluation and documentation of RIDASCREEN ELISA allergy diagnostics (total IgE, spec. IgE and IgG) ZG1101 ZG1104 ZG1105 ZG2501 ZG0701 Z9999 Z9997 Vitamin Detection RIDASCREEN Enzyme binding assays for vitamin detection Biotin Quantitative detection of biotin in serum 29

30 The R-Biopharm Group R-Biopharm AG R-Biopharm Inc. R-Biopharm España S.A. R-Biopharm Rhône Ltd. R-Biopharm France R-Biopharm Italia Srl R-Biopharm China R-Biopharm Latinoamérica R-Biopharm Brasil Ltda. R-Biopharm Australia subsidiaries distributors R-Biopharm AG An der neuen Bergstraße Darmstadt, Germany Phone: +49 (0) Fax: +49 (0) R-Biopharm AG Product Catalogue 2011/

31 Contact Details Division Management Clinical Diagnostics Dr. Wolfgang Schartl Division Management Clinical Diagnostics Phone: +49 (0) Product Management Fax: +49 (0) Allergy Diagnostics Joachim Zehender Product Manager Allergy Diagnostics Phone: +49 (0) Hannah Gören Product Specialist Allergy Diagnostics Phone: +49 (0) Infectious Diseases (Antigen Detection) Helmut Leidinger Product Manager Stool Diagnostics Phone: +49 (0) Infectious Diseases (Antibody Detection) Dr. Johanna Endt Product Manager Serological Diagnostics Phone: +49 (0) Gastroenterology Dr. Andrea Lennerz Product Manager Gastroenterology Phone: +49 (0) Stephanie Weil Product Specialist Gastroenterology Phone: +49 (0) Project Manager Infectious Diseases Molecular Diagnostics Dr. Andreas Simons Project Manager Infectious Diseases Product Manager Molecular Diagnostics Phone: +49 (0) Janina Drynski Product Specialist Molecular Diagnostics Phone: +49 (0) Clinical Sales International Fax: +49 (0) Director Clinical Sales International Jens-Uwe Wünsch Phone: +49 (0) International Sales Manager Asia / MENA Dr. Dieter Gernet Phone: +49 (0) d.gernet@r-biopharm.de International Sales Manager Europe Dr. Otto Mannherz Phone: +49 (0) o.mannherz@r-biopharm.de International Sales Manager CIS Mongolia Caucasus Anatolii Buk Phone: +49 (0) a.buk@r-biopharm.de Support Sales International Martina Scheidenberger Phone: +49 (0) m.scheidenberger@r-biopharm.de Support Sales International Carsten Müller Phone: +49 (0) c.mueller@r-biopharm.de Order Department General contact Phone: +49 (0) Fax: +49 (0) orders@r-biopharm.de Africa Jutta Wien Phone: +49 (0) Asia, Switzerland Ingrid Illich Phone: +49 (0) Europe Monika Fröhlich Phone: +49 (0) Eastern Europe Petra Vlasak Phone: +49 (0) North, Middle- and South-America, Oceania Christoph Polzin Phone: +49 (0) Secretary Petra Schorr Phone: +49 (0) p.schorr@r-biopharm.de 31

32 R-Biopharm AG Product Catalogue 2011/

33 General Terms & Conditions of R-Biopharm AG (Date of Issue: October 2010) I. General Provisions These General Terms & Conditions only are valid for entrepreneurs, legal entities under public law or public-law special assets (legal entities according to 310 I German Civil Code ( Bürgerliches Gesetzbuch - BGB ). We deliver according to these General Terms & Conditions exclusively. They are deemed to have been acknowledged with the placing of an order or the receipt of the goods and shall also apply to all future business relationships, even if they are not explicitly agreed upon again. Deviating Terms and Conditions are not binding for us, even if we do not object to them explicitly. II. Orders and Offer Documents Our offers are subject to alteration. Decisive for the scope of our delivery obligation are our offer in writing respectively our written order confirmation. Deliverable are only the products which are contained in our current applicable price lists. III. Prices and Conditions of Payment / Withdrawal in case of default 1. Purchase price is the price stated by us or - if no price has been stated - the price which is contained in our price list, which is in effect on the day of the order. The prices stated by us - unless otherwise stipulated in writing - are including packing and shipping costs, excluding VAT. The deduction of cash discounts shall not be granted. A small-quantity surcharge in the amount of 10 Euros can be charged for deliveries with a product value of up to 300 Euros (small quantity). 2. Payment obligations resulting from the delivery of goods are to be fulfilled within thirty (30) days of the invoice date by bank transfer exclusively and shall be deemed to have been effected only to the extent, to which we can dispose of them freely at a bank. For checks and bills of exchange, a processing fee of 30 Euros shall be charged; discounting and expenses shall be for the account of the Buyer. 3. The Buyer shall only be entitled to set-off with a counter-claim which is undisputed or has been determined by a final verdict. A right of retention the Buyer does only have as far as it is resulting from the same contractual relationship. 4. Should the Buyer be in default with due payments entirely or partly, the regulations of the statutory law are applicable. Interest in the amount of 8% above the basic interest rate (as it is published by the German Federal Bank) shall be due. We are reserving the right to claim any exceeding damage for delay. 5. In case of withdrawal, we are entitled - at the expense of the Buyer - to let the goods, which have been delivered by us, mark, store separately and collect. The Buyer - already yet - is declaring his consent that the persons who are commissioned with the collection are entitled to access the premises, on which the goods are, and enter them by car for this purpose. 6. In case of our withdrawal, we are not obliged to further deliveries any more, also regarding further future deliveries. IV. Retention of Title 1. We shall retain title to the goods delivered by us, until all the claims, to which we are entitled on whatever legal grounds arising from our business relationship with the Buyer, have been fully satisfied. Upon the Buyer s request, we shall be obligated to release the securities in so far as their realizable value exceeds our claims by more than 10%. We reserve the right to select the items of collateral to be released. 2. The Buyer undertakes to only sell the goods, which are subject to retention, in his ordinary course of business, according to his usual terms and conditions of business and only as long as he is not in default with his payments. He is entitled to resell the goods, which are subject to retention, only on the condition that a transfer of the receivables, resulting from such a resale, to us takes place. He is not be entitled to dispose of the goods, which are subject to retention, in any another way (such as e. g. collateral assignment, pledging, leasing, lending, etc.). The Buyer is obligated to immediately notify us of any seizure or other interference by a third party, together with handing over of the documents which are necessary for an intervention. V. Delivery 1. Our delivery times are generally only approximate and not binding. 2. Uncontrollable incidents, for which we are not responsible, e. g. natural phenomena, war, orders of the authorities, embargo, unexpected delays in the delivery of essential components and other materials ( Force Majeure ), shall prolong the delivery time reasonably. This also applies, if these incidents occur during a delay in delivery or at a sub-supplier. However, the delivery time shall be prolonged by a maximum period of two (2) months. Should we also not be able to deliver after this time, then the Buyer as well as we themselves are entitled to withdraw from the contract. Any claims of damages of the Buyer for this reason are excluded. Should we withdraw from the contract, we shall immediately refund the Buyer any and all payments possibly rendered for not yet delivered goods. 3. Should the Buyer - despite reminder - not fulfill his payment obligations resulting from existing contracts, we shall only supply on advance payment from then on. 4. We are entitled to partial deliveries to a reasonable extent; here each partial delivery can be invoiced separately. In case of order on call, the call-off has to take place at least two (2) calendar weeks prior to the desired delivery date. VI. Shipment and Passing of Risk 1. Dispatch ex works or distribution warehouse shall be carried out at the expense of the Buyer. Shipping route and mode of dispatch shall be determined by us. We shall only be obligated to obtain a transport insurance, if explicitly instructed to do so by the Buyer in writing; the Buyer shall bear the costs for this insurance. 2. The passing of risk to the Buyer takes place as soon as the goods have been handed over to the haulage contractor respectively leave our factory or distribution warehouse for the purpose of dispatch; this also is valid, if we - by way of exception - organize additional services, e. g. carriage prepaid shipping, delivery to the premises of the Buyer, or similar. In particular we are not liable for alteration or deterioration of the goods during transport or resulting from improper storage. Should we have notified the Buyer that the goods are ready for dispatch or collection, the risk passes on to the Buyer, if he does not have the goods delivered or collect them, despite of us having set him a reasonable period of time for doing so; regarding that, the passing of risk takes place at the beginning of the day which follows the day, on which the deadline has expired. VII. Warranty / Liability 1. It is precondition for the execution of claims based on a defect, that the Buyer has performed his responsibilities to examine and complain according to 377 of the German Commercial Code ( Handelsgesetzbuch - HGB ) correctly and completely. 2. We are liable for faultlessness of the goods corresponding to the state of the art. Features of samples and specimens as well as any statements regarding the condition of the goods, shall only be considered as an agreement on quality, if they explicitly have been agreed upon as determining the condition of the goods. Otherwise they are non-binding and do not free the Buyer from an own inspection of the goods concerning their suitability for his purposes. We neither grant guarantees with the content of a liability without fault nor any other kind of guarantees for quality and durability in the legal sense. 3. We are not liable for damages as far as they have been caused by improper storage of our products and/or their application contrary to the prescriptions - e. g. application after expiry of their shelf life or contrary to the direction for use - or as far as they have been caused by the Buyer in any other way. 4. The exceeding of use-by dates after the delivery does not entitle the Buyer to claims of any kind, but is deemed to be the usual condition. This is not the case, if the period between the date of delivery and the use-by date is less than four (4) calendar weeks. 5. We shall only be liable for damages, as far as we attributable have caused them by intent or gross negligence (disregard for the due care and attention to a very coarse extent); except in case of violation of essential contractual obligations (obligations, whose fulfillment enables the proper execution of the contract at all and on whose observance the contractual partner may rely regularly). In this last-mentioned case we are liable for each negligence with the restriction that - in case of violation of essential contractual duties by slight negligence - our liability is limited to the damage which typically is predictable. 6. Should we not have violated any essential contractual obligations in the sense mentioned before, we are not liable in cases of slight negligence. Unaffected by any limitation of liability contained in these General Terms & Conditions stay: Liability for intent, malice, initial inability, gross negligence, liability resulting from a guarantee (which, however, we generally not grant), bodily harms and other cases of legally compelling liability - in these cases the statutory law is valid (under exclusion of the Terms and Conditions of our contractual partner). 7. The regulations of this clause Warranty/Liability are valid for our contractual liability as well as liability resulting from tort (unaffected thereby stays the action for possession in case of tort, after statutory limitation has taken place, 852 German Civil Code ( Bürgerliches Gesetzbuch -BGB )). 8. As far as our lability is excluded or limited, this shall also apply to the personal liability of our representatives, employees and vicarious agents and our liability for them. 9. As far as there is a defect of the goods, for which we are liable, the Buyer has to grant us the opportunity to execute subsequent performance within a term of generally two (2) calendar weeks, before the assertion of his further rights. In case that subsequent performance fails twice, in case of our refusal, or if subsequent performance is impossible, is delayed unreasonably or unreasonable for the Buyer due to other reasons, the Buyer may - according to his choice - execute his further legal rights, namely rescission or reduction of the purchase price and (regarding defects for which we are liable) claim of possibly occurred damages or compensation for possible futile expenditure, by which our liability is limited according to the preceding regulations. VIII. Burden of Proof / Export / Effectiveness 1. With none of the stipulations of these General Terms & Conditions an alteration of the burden of proof is intended. 2. We are not liable for the correctness of information regarding foreign-trade which we provide to our best conscience; it is the Buyer s responsibility to assess the compliance with foreign-trade regulations with regard to our products himself. 3. Should any of the regulations of our General Terms & Conditions be ineffective and/or incomplete, the validity of the other regulations shall remain unaffected thereby. IX. Applicable Law and Place of Jurisdiction 1. The contractual relationship shall be governed by the laws of the Federal Republic of Germany, which shall be applicable supplementary. The UN-convention on contracts regarding the International Sale of Goods (CISG) shall not apply. 2. Exclusive Place of Jurisdiction is Darmstadt (Germany). However, we are entitled to file a lawsuit against the Buyer also at any other court, which does have jurisdiction regarding him according to the general regulations. 33

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36 08/2011 R-Biopharm AG An der neuen Bergstraße 17, Darmstadt Phone: +49 (0) , Fax: +49 (0) R-Biopharm AG Product Catalogue /