Royalty Report: Drugs, Alzheimer’s disease, Disease – Collection: 27552

License Grant

University has granted diagnostic rights to certain knowhow and patent rights relating to Alzheimer's Disease.

This Agreement initially contemplates a transfer of existing Alzheimer Therapeutic Know-how to Licensee. Pursuant to such initial transfer and continuing collaboration thereafter, it is contemplated that Licensee will determine the amino add sequence of proteins and base sequence of nucleic acids, generate monoclonal antibodies, done and express and assess biological and therapeutic activity of proteins, all related to the Field of this Agreement.

In addition, Licensee will engage in a collaborative research project directed to the Field and funded by Licensee, which collaboration is contemplated to include
a.  development by Licensee of therapeutics based on specific materials provided; and
b.  other related research and development related to the development by Licensee of therapeutics for Alzheimer's disease.

Field of Use

The field of use is therapeutics for Alzheimer's disease and precursor or related conditions, including any applications in other neurodegenerative diseases derived from the results of the research done under this Agreement.

License Grant

Under the collaboration agreement, the German Company grants the partner an exclusive license to certain therapeutic antibodies for specific targets and receives license fees, research and development funding, milestone payments and/or, if a product is approved for marketing, sales royalties in return.  Through the Partnered Discovery Program, the Company generates antibody candidates for partners in the pharmaceutical and biotechnology industries. A HuCAL antibody targeting amyloid beta that is in phase 3 clinical testing by our partner for the treatment of Alzheimer’s disease is Gantenerumab.

License Property

Gantenerumab is a HuCAL antibody directed against amyloid beta (Aß) that is being developed for the treatment of Alzheimer’s disease. Aß denotes a group of peptides that are crucially involved in Alzheimer’s disease as the main component of the amyloid plaques found in the brains of Alzheimer’s patients. In phase 1 clinical trials, gantenerumab has been shown to reduce brain amyloid in mild-to-moderate Alzheimer’s disease patients. Gantenerumab is being investigated in several clinical studies to see if there is a positive effect from intervening at an early stage in the disease’s progression.

Field of Use

Gantenerumab is an investigational immunotherapy being developed to treat Alzheimer’s disease by potentially reducing beta-amyloid plaques in the brain.

License Grant

University hereby grants to Israel Corporation and Corporation hereby accepts from University the License. License shall mean the exclusive worldwide license to practice University’s share in the University Research Technology (as hereinafter defined) for the development, manufacture, use and sale of the Licensed Products (as hereinafter defined). At the initiative of Corporation or University, the parties shall consult with each other regarding the prosecution of all patent applications with respect to the University Research Technology. University and Corporation shall assist, and cause their respective employees and consultants to assist, each other in assembling inventorship information and data for the filing and prosecution of patent applications on inventions pertaining to the Research Technology. Corporation shall be entitled to grant sublicenses under the License on terms and conditions in compliance and not inconsistent with the terms and conditions of this Agreement (except that the rate of royalty may be at higher rates than those set forth in this Agreement) (i) to a Corporation Entity or (ii) to other third parties for consideration and in an arms-length transaction.

License Property

Licensed Products shall mean all products, drugs, diagnostic reagents, diagnostic methods, therapeutic agents and therapeutic methods covered by a claim of any unexpired University Patents (as hereinafter defined) which has not been disclaimed or held invalid by a court of competent jurisdiction from which no appeal has been or can be taken.

University Research Technology shall mean all University Patents and all University Know-How.

University Patents shall mean all United States and foreign patents and patent applications, and any divisions, continuations, in whole or in part, reissues, renewals and extensions thereof, and pending applications therefor
(1)  
which claim Pre-Existing Inventions and which are identified hereto; or
(2)  
which claim inventions that are made, in whole or in part, by students or employees of SAMSF during the term and in the course of the Research Project;  
with the exception of all such patents which are Corporation Patents as hereinafter defined.
U.S. Patent Application Serial No. 08/801,301, filed February 18, 1997 entitled Use if Nekatibub To Prevent Cytotoxic effects of Amyloid Protein by Pappolla.
U.S. Provisional Patent Application Serial No. 60/075,555 filed February 23, 1998 entitled Use of 3-Indol-Proprionic acid by Pappolla
U.S. Provisional Patent Application Serial No. 60/079,349 filed March 25, 1998 entitled Inhibition of Alzheimer of Alzheimer Beta-Fibrillogenesis by Mela Tonm by Pappolla.

Corporation Patents shall mean all United States and foreign patents and patent applications, and any divisions, continuations, in whole or in part, reissues, renewals and extensions thereof, and pending applications therefor which claim inventions that are made, in whole or in part, by students or employees of Corporation.

Research Technology shall mean all University Patents, University Know-How, Corporation Patents and Corporation Know-How.

Field of Use

Field shall mean research, development and testing within pharmaceutical, biotechnological and diagnostic development programs in the field of Alzheimer’s Disease and other central nervous system and neurodegenerative diseases, and in the field of all other possible utilities for melatonin analogs.

License Grant

The Licensor, a nonprofit American academic medical center, grants to Licensee a non-exclusive License in the territory within the Field of Use, without the right to subLicense (except to its Affiliates), to use and breed the Licensed Technology, and to use the Licensed Know-How, under the Mayo Patent Rights, according to the terms of this LSRA.

License Property

Licensed Technology means mice of the Tg 2576 strain of the transgenic mouse model described in Hsiao et al, Correlative Memory Deficils, A-Beta Elevation and Amyloid Plaques in Transgenic.  All reference to the singular shall include the plural and vice-versa.  169 Patent Rights mean U.S. Patent Number 5,455,169, issued October 3, 1995. MAYO believes that dissemination of these transgenic mice to researchers is of potential great benefit to present and future patients having Alzheimer's Disease and other neurodegenerative diseases.

DEVELOPMENT PROGRAMS. means pharmaceutical, biotechnological and diagnostic development programs in the field of Alzheimer's Disease and other central nervous system and neurodegenerative diseases as performed by LICENSEE or its Affiliates.

LICENSED TECHNOLOGY. means (a) mice of the Tg 2576 strain of the transgenic mouse model described in Hsiao et al, Correlative Memory Deficils, A-Beta Elevation and Amyloid Plaques in Transgenic Mice, as published in Science on October 4, 1996, or in a U.S. continuation-in-part patent application, filed June 17, 1996, Serial No. 08/664,872 (the “CIP Application”), which mice are (1) progeny of a cross of a Tg2576 N2 male with a C57B6SJL female or (2) the progeny of a cross between (Tg2576 N2 x C57B6SJL) male with a C57B6SJL female, (such mice referred to herein as” Stock”); (b) progeny of the Stock; and (c) certain transgenic mice that may result from the Sponsored Research Activities.

License Grant

Licensor hereby grants Licensees of the Netherlands and Ireland, an exclusive, even as to Licensor, license, with the right to grant sublicenses, under the Licensed Patents to research, develop, use, have used, make, have made, offer for sale, sell, have sold, import and export Bapineuzumab Products in the Field in the Territory.

Licensor hereby grants each Licensee a non-exclusive license, with the right to grant sublicenses, under the Licensed Patents to research, develop, use, have used, make, have made, offer for sale, sell, have sold, import and export Licensed Products other than Bapineuzumab Products in the Field in the Territory.

License Property

Licensed Products shall mean any therapeutic, prophylactic and/or diagnostic product, the composition, manufacture or use of which would, but for the licenses granted by Licensor to Licensees herein, infringe a Valid Claim of a Licensed Patent owned or otherwise Controlled by Licensor.

The patents relate to DNA Encoding Recombinant Antibody Molecules End Specific for Amyloid ß Peptide.

Aß Peptide shall mean P-amyloid protein which is the cleavage product of amyloid precursor protein, occurring predominantly as a (1-39) to (1-43) amino acid.

Field of Use

Field shall mean the treatment, prevention and/or diagnosis of diseases and/or conditions in humans, including but not limited to Alzheimers Disease  and Mild Cognitive Impairment.