Royalty Report: Drugs, Respiratory, Disease – Collection: 291183

License Grant

University grants to Licensee to the extent of the Licensed Territory an exclusive license under the Patent rights and University Technology to make, have made, use and sell Licensed Products.

License Property

The patent is for Method of Treating Lung Disease with Uridine Triphosphates.

University owns and controls the inventions described in U.S. Patent No. 5,292,498 entitled 'Method of Treating Lung Disease with Uridine Triphosphates,' certain inventions relating to the therapeutic use of phenamil and benzamil for lung disease, and certain inventions relating to the diagnosis of AIDS-related Pneumocysitis carinii pneumonia ('PCP'), lung cancer, and tuberculosis (collectively, the 'Inventions').

Field of Use

The field is the therapeutic use of phenamil and benzamil for lung disease, and certain inventions relating to the diagnosis of AIDS-related Pneumoeysitis carinii pneumonia (PCP), lung cancer, and tuberculosis.

License Grant

University grants to Licensee to the extent of the Licensed Territory an exclusive right and license to use University Technology in the Licensed Field, subject to all the terms and conditions of this Agreement.

License Property

University owns and controls an invention known as Methods of Combating Pneumocystis carinii Pneumonia (PCP) and Compounds Useful Therefore (file #ORS93-17) as well as other compounds described herein that may have potential for the treatment of PCP as well as other indications such as HIV, anti-fungal, anti-inflammatory, anti-bacterial, anti-viral and the like, all of which compounds, including the compounds in file #ORS93-17 are hereinafter referred to as the compounds and, together with the methods described in file #ORS93-17, are referred to as the Invention.

Field of Use

Licensed Field means Treatment of Pneumocystis carinii Pneumonia in Humans.

License Grant

For the Development License,  Licensor hereby grants to the Japanese Licensee, the co-exclusive, with Licensor, a license under the Licensed Technology, to conduct the Development Program, either in the Territory or outside of the Territory, as Licensee may determine is appropriate.

For the Commercialization License, Licensor grants an exclusive right and license throughout the Territory under the Licensed Technology, to develop, use, have used, make, have made, register, market, sell, have sold, export and import Products in the Field, and the right to make or have made the Compound used in the manufacture of the Products and/or the Products, either in the Territory or outside the Territory, for use for Products in the Territory and in the Field.

License Property

The patents relate to Methods of Detecting Lung Disease.

The licensed property is the Patents and Know-How relating to the Compound.

The Compound shall mean the chemical compound designated as INS316, whose chemical name is UTP (Uridine 5-Triphosphate).

INS316 Diagnostic is an inhaled diagnostic drug to aid in the detection of lung cancer and lung infection.

Method of Detecting Lung Disease
U.S. Patent No. 5,628,984

Method of Detecting Lung Disease
U.S. Patent No. 5,902,567

A Sterilized Isotonic and pH-Adjusted Pharmaceutical Formulation of Uridine Triphosphate
U.S. Patent No. 5,962,432

Novel Pharmaceutical Compositions of Uridine Triphosphate
U.S. Patent No. 5,968,913

Method of Detecting Lung Disease
U.S. National Phase Application of WO97/05195, U.S. Serial No. 08/776,772

Method of Detecting Lung Disease
U.S. Con. of #5 above; Filed 4 Nov 1999; Serial No. 09/433,757

Field of Use

INS316 Diagnostic to aid in the diagnosis of lung cancer and lung infection

The Field shall mean use as an acute use agent to facilitate production of a specimen for use in diagnosing, monitoring, staging or detecting diseases and/or infections. All therapeutic uses are expressly excluded from the Field.

License Grant

This Letter Agreement is a binding agreement setting forth the terms upon which the Parties will research, develop, finance the research and development of, manufacture and market the technology and compounds owned by a consortium of Universities and currently licensed or optioned to Licensor B and described hereto (the Current Compounds) and all technology and compounds developed by the Consortium after the date hereof through use of Licensee sponsored research funding or National Cooperative Drug Development grant funding made available to the Consortium (the Future Compounds and, collectively with the Current Compounds, the Compounds).

License of the Compounds.

(a) From the date of this Letter Agreement until the completion of the IPO or an Alternative Financing, Licensee may request Universitys written consent for Licensee to use one or more of the Compounds to conduct clinical studies.   Licensee will also have the right to describe, and to provide information regarding, the Compounds to facilitate the completion of the IPO or an Alternative Financing.

(b) Upon the completion of the IPO or an Alternative Financing, Licensor B will grant or assign to Licensee, and University will take any action necessary to consent to the grant or assignment by Licensor B to Licensee of, an exclusive worldwide license to use, manufacture, have manufactured, promote, sell, distribute or otherwise dispose of any and all products based directly or indirectly on the Current Compounds (the Current Products).

(c) Licensee will have the right to grant sublicenses to any third party who agrees to be bound by the terms of this Letter Agreement in accordance with the terms of its License Agreement with University.

(d) Upon completion of the IPO or an Alternative Financing, University will grant to Licensee, and Licensor B will take any action necessary to consent to the grant by University to Licensee of, an exclusive worldwide license to use, manufacture, have manufactured, promote, sell, distribute or otherwise dispose of any and all products based directly or indirectly on the Future Compounds (the Future Products and, collectively with the Current Products, the Products).

License Property

Dicationic compounds have two positively charged ends held together by a neutrally charged chemical linker group. The unique structures of the compounds with positive charges on the ends (shaped like molecular barbells) allow them to bind to the negatively charged surface in the minor groove of an organism's DNA (like a band-aid), preventing necessary life-sustaining enzymes from attaching to the DNA's active sites. Once a site is occupied by one of the compounds, the necessary enzyme cannot bind to the DNA, preventing the organism from dividing and stopping the spread of the related disease by inhibiting or killing the growth of the organism.

Current Compounds
Invention                                                                        Filed In                                         Issued-App. or Patent #

Dications – Treatment of Pneumocystis carinii        US                                                 US – June 12, 1990 4,933,347
Pneumonia (0RS88-4)

Dications – Treatment of Leishmaniasis                    US                                                 US – April 13, 1993 5,202,320
             (0RS88-4)
ions – Treatment of Malaria                                         US, EPO, Argentina,                   US – April 27, 1993 5,206,236
             (0RS88-4)                                                            Brazil, Australia, Canada          EPO – March 1, 1995 0,366,066
                                                                                         China, Denmark, Israel,            Argentina – May 31, 1995 248,011
                                                                                         Japan, Mexico, Pakistan,          Australia – Jan 25, 1993 626,033
                                                                                         Philippines, Korea,                    Mexico – August 30, 1995 179,371
                                                                                         Switzerland, Venezuela,           Pakistan – Oct. 19, 1989 131,965
                                                                                         Finland, India, Norway,            Switzerland – Apr 30, 1996
                                                                                         Taiwan                                         Venezuela – Jan 5, 1996

Dications – Treatment of Fungal Infections               US                                               DIV-08/641,510
             (0TD95-51)                                                                                                             USSN-08/472,996

HIV – Inhibition of the Integrase Enzyme                  US, PCT, Australia, Brazil,        US- 08,185,079 NZ-279619
             (0RS94-34)                                                         Canada, Japan, New                PCT- PCT/US95/01599
                                                                                         Zealand, EPO, Venezuela        AU- 16798/95 VZ-503-96
                                                                                                                                            EPO- 95908504.4
Dications – Detection of nucleic acids and                US, PCT
  cytoskeleton elements (0RS94-43)

Inhibition of Pneumocystis carinii Pneumonia         US, PCT, Argentina, Israel,    US – May 28, 1996 5,521,189
             (0RS94-81)                                                          South Africa, Taiwan              DIV-08/564,879

Inhibition of Giardia Lamblia                                        US, PCT, Argentina, Israel,
             (0RS94-81)                                                           South Africa, Taiwan

Inhibition of Cryptosporidium parvum                       US, PCT, Argentina, Israel,
             (0RS94-81)                                                           South Africa, Taiwan

Inhibition of Pneumocystis carinii Pneumonia         US, Canada, PCT, Japan,        US – June 27, 1995 5,428,051
             (0RS93-17)                                                          Brazil, Australia, New
                                                                                          Zealand, EPO, Venezuela

Prodrugs for PCP Infection                                           US                                             USSN-08/558,716
             (0RS95-50)
Methods of Treating Microbial Infections                   US                                            USSN-08/474,440
             (0TD95-48)                                                                                                            USSN-08/477,876
                                                                                    
TIDWELL                                                                                                                             PCT/US96/08972

Field of Use

The objective of the Licensee's pharmaceutical program is the development of effective, safe drugs against a variety of micro-organisms, including fungal, protozoan, parasitic, bacterial, and viral micro-organisms.

The Licensee has two dicationic compounds ready to begin human clinical trials. The first compound, DAP-092, is for the treatment of Cryptosporidium parvum, a parasite that causes severe diarrhea and wasting. The second compound, DB-289, is for the treatment of Pneumocystis carinii pneumonia. These two orally administered drugs are ideally suited to demonstrate the power of the dicationic technology platform. DAP-092 was developed to treat a parasite that is found only in the gastro-intestinal tract ('gut'). DAP-092, because of its positive charges, cannot cross the digestive membranes, and stays in the digestive tract.