Hologic Gen-Probe, Novartis, DiagnoCure, University of Michigan, Roche, Stratec, bioMŽrieux, Rebio Gen Inc., Siemens, Chiron, PROCLEIX, PCA3, PSA, Prostate Cancer Tissue, Hoffmann-La Roche Ltd., Human Papillomavirus (HPV), DNA probes, RNA, TMA

Collaborations

Hologic 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.

Novartis: In June 1998, we entered into a strategic alliance with Chiron Corp (since acquired by Novartis) to develop and market nucleic acid tests and instruments for the blood screening market. The alliance has developed, and is manufacturing and marketing, the PROCLEIX HIV-1/ HCV assay, which simultaneously detects the virus that causes AIDS and the hepatitis C virus; the PROCLEIX ULTRIO assay, which also detects the hepatitis B virus; and the PROCLEIX WNV (West Nile virus) assay. The PROCLEIX ULTRIO and WNV assays can both be run on the fully automated, high-throughput TIGRIS system. In early 2009, the collaboration was amended and extended to the year 2025.

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.

University of Michigan: In April 2006, we entered into a license agreement with the University of Michigan for exclusive worldwide rights to develop and commercialize diagnostic tests for recently discovered genetic translocations that have been shown in preliminary studies to be highly specific for prostate cancer tissue.

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(R) format HPV test kits to detect high-risk subtypes of HPV.

Stratec: In November 2006, we entered into development and supply agreements with Stratec Biomedical Systems AG. Under the agreements, Stratec will help develop, and manufacture, our fully automated, mid-volume molecular diagnostic instrument, known as the PANTHER system. We expect to launch the PANTHER system in Europe at the end of 2010.

Roka Bioscience, Inc.: In September 2009 Gen-Probe announced the spin-off of its industrial testing assets into a new, independent company focused on developing rapid, highly accurate molecular assays for biopharmaceutical production, water and food safety testing, and other applications.

Gen-Probe will receive royalties on any potential Roka product sales, and retain rights to use the CUDA system for clinical applications. In addition, Gen-Probe will provide contract manufacturing and certain other services to Roka on a transitional basis.

Life Technologies Corporation (LTC): In January 2010 Gen-Probe Life Sciences entered into partnership with Life Technologies to commercialise specified Elucigene products under LTC's Applied Biosystems brand. Gen-Probe will manufacture and supply it's Elucigene QST*R products for chromosome aneuploidy testing to Applied Biosystems for sale in defined territories. The Agreement provides for worldwide commercialisation but excludes the United States and Western Europe. Gen-Probe will continue to sell the QST*R products under the Elucigene brand throughout Western Europe. The partnership can be extended in the future to include additional Elucigene products and territories by mutual agreement.

Distribution

bioMerieux: In September 2004, Gen-Probe entered into non-exclusive licensing agreements with bioMerieux and its affiliates that provide bioMerieux 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.

Siemens: We supply our transcription-mediated amplification (TMA) assay for the qualitative detection of the hepatitis C virus to Siemens (formerly Bayer) pursuant to a collaboration agreement. We also supply Siemens with analyte specific reagents (ASRs) for the quantitative detection of HCV.