Immunoglobulin and T-cell Receptor Clonality patents

As to core method patents covering diagnosis of clonality by PCR or other amplification technologies: We have successfully negotiated scores of sublicenses with prominent institutions, including most or all major private reference laboratories in the United States and a rapidly growing list of University hospitals. If you are not interested in obtaining a sublicense to these patents but wish to perform PCR testing of these genes, we are happy to provide contact information for leading CAP-accredited and CLIA-licensed laboratories authorized to perform testing.

Sublicenses require a license issue fee and continuing royalty payments. Delay in sublicensing will at best defer the payment of accruing continuing royalties, and may well lead to an increase in the license issue fee or a decision not to issue a sublicense at all.

Please note that continuing royalties are substantially lower for laboratories that use our standardized testing kits exclusively for testing. These test kits have been validated and are being used by leading cancer centers around the world to identify and monitor leukemias, lymphomas and other lymphoproliferative diseases.

We reserve the right to reduce the license issue fee for laboratories that have not started testing prior to securing a sublicense, and for non-reference laboratories that have been doing testing exclusively using our testing kits.

IVS is under no obligation to grant sublicenses to this technology and may decide to limit the number of sublicenses ultimately issued. It is in the best interests of all parties to contact us immediately to discuss sublicense terms if you are currently practicing, or plan on practicing PCR amplification and detection of rearrangements of the immunoglobulin or T cell receptor genes.

FLT3 Mutation Detection patents

Under its July 6, 2006 exclusive agreement with Takara Bio Inc. of Shiga, Japan, IVS is allowed to develop, manufacture, and sell testing reagents usable for FLT3/ITD detection. FLT3 tandem duplication (TD) and FLT3 length mutations (LM) are alternative designations for FLT3 ITD mutations. Accordingly, they are covered under these patents. Pursuant to that license, IVS also has the authority (but not the obligation) to sublicense the right to conduct patent covered tests to institutions such as diagnostic testing firms and hospitals that engage in compensated FLT3/ITD testing services.