Collaborations

Gen-Probe has formed collaborations and strategic alliances with a number of companies to gain access to new technologies, products and markets. Several of these collaborations/alliances are listed below.

Chiron Corp.: In June 1998, we entered into a strategic alliance with Chiron to develop and market NAT-based products for the blood screening and clinical diagnostic markets. The Gen-Probe/ Chiron alliance initially developed and is manufacturing and marketing the combination HIV-1/ HCV assay for qualitative screening of blood and blood products under the PROCLEIX name. As well as additional blood screening assays, such as the PROCLEIX ULTRIO assay and the WNV assay.

DiagnoCure: In November 2003, Gen-Probe signed a license and collaboration agreement with DiagnoCure under which the companies are developing, and Gen-Probe will market, an innovative urine test to detect a new, highly specific genetic marker for prostate cancer. The diagnostic test will detect a recently described gene called PCA3 that has been shown by studies to date to be over-expressed only in malignant prostate tissue. The test may offer advantages over prostate specific antigen (PSA) testing, the current standard for initial prostate cancer screening in conjunction with a digital rectal exam. Gen-Probe owns exclusive worldwide marketing rights to diagnostic products resulting from the agreement.

Roche: In February 2005, Gen-Probe signed a supply and purchase agreement with F. Hoffmann-La Roche Ltd. and its affiliate Roche Molecular Systems, Inc. under which Gen-Probe will purchase products for use in molecular diagnostic assays for human papillomavirus (HPV). Under the agreement, Roche will manufacture DNA probes for HPV, which Gen-Probe will purchase at agreed-upon transfer prices. Gen-Probe also has agreed to pay initial manufacturing fees in two installments. Gen-Probe plans to use HPV probes supplied by Roche in APTIMA® format HPV test kits to detect high-risk subtypes of HPV.

General Electric: In July 2005, Gen-Probe and GE Infrastructure, Water & Process Technologies, a unit of General Electric Company will work together on an exclusive basis to develop, manufacture and commercialize nucleic acid testing (NAT) technologies that are designed to detect the unique genetic sequences of microorganisms in selected water applications.

3M: In December 2006, Gen-Probe formed an exclusive worldwide collaboration with 3M to develop, manufacture and market innovative nucleic acid tests (NATs) to enhance food safety and increase the efficiency of testing for food manufacturers. Under the terms of the collaboration, 3M is responsible for developing sample processing methods that will be used with Gen-Probe's NATs. 3M also is responsible for obtaining the necessary regulatory licenses and approvals to commercialize the products, and for selling and marketing them worldwide. Gen-Probe is responsible for assay development and manufacturing.

Millipore Corporation: In August 2005, Gen-Probe and Millipore formed an alliance to develop, manufacture and commercialize on an exclusive basis nucleic acid testing (NAT) products for rapid microbiological and virus monitoring in the biotech and pharmaceutical industries. Microbiological monitoring of manufacturing processes is critical to ensuring patient safety and meeting regulatory requirements. The companies believe the combination of Gen-Probe's proprietary nucleic acid amplification and detection technologies with Millipore's technologies and expertise in microbial process monitoring applications will allow the creation of the next generation of process monitoring tools for the biotech and pharmaceutical industries.

Molecular Profiling Institute Inc.: In October 2005, Gen-Probe formed a non-exclusive collaboration with the Molecular Profiling Institute Inc. (Molecular Profiling), a private, specialty reference laboratory, to accelerate market development for Gen-Probe's pipeline of novel cancer diagnostics. Molecular Profiling is the for-profit reference laboratory of the Translational Genomics Research Institute (TGen), a non-profit biomedical research institute whose mission is to make and translate genomic discoveries into advances in human health. Under the terms of the agreements, Molecular Profiling has agreed to validate, commercialize and undertake market development activities for up to four Gen-Probe products, starting with the Company's investigational PCA3 assay, which is intended as an aid in the diagnosis of prostate cancer. As part of the collaboration, Gen-Probe has acquired a minority interest in Molecular Profiling.

Corixa: In January 2005, Gen-Probe signed an agreement with Corixa to license rights to develop molecular diagnostic tests for approximately 50 potential genetic markers in the areas of prostate, ovarian, cervical, kidney, lung and colon cancer. The agreement is a significant step forward in our long-term strategy to become a leader in cancer diagnostics. Gen-Probe gains access to certain Corixa intellectual property covering multiple genetic sequences related to these potential markers, which include AMACR for prostate and colon cancers, CA125 for ovarian cancer, and L523S for cervical and lung cancers.

Qualigen: In November 2004, Gen-Probe acquired from Qualigen® an exclusive option to develop a point-of-use nucleic acid testing (NAT) instrument based on Qualigen's FDA-approved FastPack immunoassay system. If development is successful, the portable instrument would use Gen-Probe's NAT technologies to rapidly detect, at the point of sample collection, the presence of harmful microorganisms and genetic mutations. The platform could be used in physicians' offices, outpatient clinics, blood screening centers and various industrial settings. Gen-Probe is now evaluating the feasibility of adapting Qualigen's immunoassay platform to perform NAT using Gen-Probe's proprietary technologies.

AdnaGen: In January 2005, Gen-Probe signed an agreement with AdnaGen, a private company based in Germany, to license AdnaGen's innovative “immunocapture” technology. The technology may help increase the accuracy of molecular diagnostic tests to detect prostate and other cancers, help determine the aggressiveness of these malignancies, and monitor responses to therapy. Under the terms of the agreement, Gen-Probe gains exclusive access to AdnaGen technology for molecular diagnostic tests for prostate and bladder cancers. Gen-Probe also retains options to obtain exclusive licenses to use AdnaGen's technology in molecular diagnostic tests for certain other cancers.

Tosoh Corporation: In December 2003, we entered into agreements with Tosoh Corporation to cross-license intellectual property covering certain NAT technologies. The licenses cover products in clinical diagnostics and other related fields.

Distribution

bioMérieux: In September 2004, Gen-Probe entered into non-exclusive licensing agreements with bioMérieux and its affiliates that provide bioMérieux and its affiliates options to access our ribosomal RNA technologies for certain uses to develop diagnostic products for certain disease targets using our patented ribosomal RNA technologies.

Rebio Gen Inc.: In July 2001, we entered into a license agreement with Chugai Diagnostics Science Co., Ltd., acquired by Fujirebio, which re-named the company Rebio Gen, Inc. The agreement offers a non-exclusive license for Japan in the field of human clinical diagnostics to various of our proprietary technologies, including TMA and HPA technology.







2008 Gen-Probe Incorporated
10210 Genetic Center Drive
San Diego, CA 92121

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