Royalty Report: Drug Discovery, Medical, Cancer – Collection: 372510

License Grant

Licensor, a non-profit research institute, hereby grants to Licensee and its affiliates for the term a royalty-bearing license under the Patent Rights to develop, make, have made, use, sell, offer to sell, lease, and import Licensed Products in the Field in the Territory and to develop and perform Licensed Services in the Field in the Territory.

License Property

Licensed Product will mean any product that, in whole or in part, absent the license granted hereunder, would infringe, or is covered by, or when manufactured, or when used, practices one or more claims of the Patent Rights.

U.S. Provisional Patent Appl. No. 61/379,327
PCT/US2011/(number not yet assigned) 'Formation and maintenance of mesenchymal and stem-cell states in the breast by paracrine ad autocrine signals'
PCT/US2006/25589 ' Progenitor Cells and Uses Thereof'

Cancer stem cells, or CSCs are also sometimes referred to as tumor-initiating cancer cells, are responsible for the initiation, metastasis and recurrence of many cancers and may be a key reason for the ultimate failure of many current therapies to achieve a durable clinical response.

A persistent problem in the discovery of drugs targeting CSCs is the difficulty of isolating large numbers of CSCs. Without such large numbers, the discovery of drugs targeting CSCs using high-throughput screening is extremely difficult. Moreover, when CSCs are isolated, they typically do not remain stable in culture. Instead, over a short period of time, CSCs convert into other types of cancer cells. To address this problem, our scientific co-founders developed proprietary technology based on the EMT process to create a stable population of CSCs that are suitable for use in high-throughput screening of small molecule compounds.

Field of Use

Field will mean cancer diagnostics and companion clinical uses.

License Grant

Licensor hereby grants to United Kingdom Licensee a sole and exclusive (even as to Licensor), royalty-bearing, worldwide license under the Licensor Patent Rights to research, develop, make, have made, use, have used, sell, have sold, offer for sale and import Licensee Products in the Licensee Transplantation Field.

Licensor hereby grants to Licensee a sole and exclusive (even as to Licensor), royalty-bearing, worldwide license under the Licensor Patent Rights to make and use c-MycER Cells to research, develop, make, have made, use, have used, sell, have sold, offer for sale and import Licensee NCTs in the Licensee Discovery Field.

Licensor hereby grants to Licensee a non-exclusive, royalty-bearing, worldwide license, under the Licensor Patent Rights to research, develop, make, have made, use, have used, sell, have sold, offer for sale and import, Unregulated Cells in the Licensee Reagent Field.

License Property

c-MycER Cells shall mean human neural Stem Cells and Progenitor Cells conditionally immortalized with the c-Myc oncogene with an estrogen response element under tamoxifen control. c-MycER Cells shall not include human neural Stem Cells or Progenitor Cells or their progeny or derivatives that are not conditionally immortalized with c-myc under the control of the estrogen response element.

Stem Cell shall mean an undifferentiated Cell capable of proliferation, self maintenance and the production of a large number of differentiated functional progeny.

Progenitor Cell shall mean an undifferentiated Cell capable of limited proliferation and the production of differentiated functional progeny.

Cell Line shall mean c-MycER Cells of clonal origin, differentiated by the integration site of the c-MycER Cell insert.

Cells shall mean cultures of neural Stem Cells to the full extent described or claimed in the Licensor Patent Rights and shall include all progeny and derivatives of such stem cells (including Progenitor Cells and their progeny and Stem Cells and their progeny) and “Cell” shall mean one of such cells.

Licensee NCT shall mean a non-cellular therapeutic molecule, i.e., a new chemical or biological molecule, identified or developed by Licensee through the practice of inventions claimed in or covered by one or more of the Licensor Patents or molecules derived therefrom, which identification or development occurred during the term of a Valid Claim of any such Licensor Patent.

Licensor Patent Rights shall mean
(a) the patents and patent applications (the Licensor Patents),
(b) any and all United States or foreign patents and patent applications corresponding to any of the foregoing patents and patent applications, whether now existing of hereafter filed,
(c) any provisionals, substitutions, divisionals, reissues, renewals, continuations, continuations-in-part (but only to the extent not directed to new matter), extensions (including patent term extensions), substitute applications and inventors’ certificates arising from, or based upon, any of the foregoing patents or patent applications, in respect of the foregoing;
(d) any patents issuing from any of the foregoing patent applications; and
(e) any issued patents now or hereafter owned or Controlled by Licensor or an Affiliate of Licensor to the extent necessary or useful for the manufacture, use or sale of
(i) a c-MycER Cell (including without limitation a product utilizing a c-Myc-ER Cell) identified or developed, in whole or in part, through the practice by Licensee or a sub-licensee of Licensee of inventions claimed in or covered by one or more of the Licensor Patents, or
(ii) a Licensee NCT.

Licensee Product shall mean a c-MycER Cell or a product utilizing a c-MycER Cell identified or developed, in whole or in part, through the practice by Licensee or a sub-licensee of Licensee of inventions claimed in or covered by one or more of the Licensor Patents, which practice occurred during the term of a Valid Claim of any such Licensor Patent.

Field of Use

Licensee Transplantation Field shall mean Transplantation of c-MycER Cells for the diagnosis, prevention and treatment of human diseases other than those in the Licensor Field.

Licensee Discovery Field shall mean use of c-MycER Cells for the research, discovery, screening and development of new non-cellular therapeutics for use in the treatment of any disease state or condition in humans.

Licensee Reagents Field shall mean use of Unregulated Cells for research and other non-clinical and non-therapeutic purposes (not including administration to humans).

License Grant

This agreement is to identify Prognostic Signatures capable of predicting responsiveness of an organism to therapeutic compounds upon the terms and conditions.

For Therapeutic Use, upon exercise of the Option for a specified Non-MAP Collaboration Target,  Licensor grants  an exclusive license in the Territory under the Licensor Patent Rights and Licensor Know-How, with a right to sublicense for any and all Therapeutic Uses, to develop, make, have made, use, offer to sell, sell and/or import Collaboration Compounds and/or Products Directed at such Non-MAP Collaboration Target for Therapeutic Use.

For Diagnostic Use, upon exercise of the Option for a specified Non-MAP Collaboration Target Licensor grants a non-exclusive license in the Territory under the Licensor Patent Rights and Licensor Know-How, with a right to sublicense for any and all Diagnostic Use, to develop, make, have made, use, offer to sell, sell and/or import Collaboration Compounds and/or Products Directed at such Non-MAP Collaboration Target for Diagnostic Use.

For Biologicals, upon exercise of the Option for a specified Non-MAP Collaboration Target that is not an Additional Biological Target,  Licensor grants a non-exclusive license in the Territory under the Licensor Patent Rights and Licensor Know-How, with a right to sublicense, to develop, make, have made and use Biologicals Directed to a NonMAP Collaboration Target or Discovery Target for the sole purpose of the research and/or development of a Product for Therapeutic Use and/or Diagnostic Use.

For MAP Collaboration Targets, upon Licensees payment of the MAP Technology Access Fee for a specified MAP Collaboration Target Licensor grants a non-exclusive license under the Licensor Patent Rights and Licensor Know-How that arise from the activities under the MAP Target Research Plan to develop, make, have made, use, ·
offer to sell, sell and/or import inhibitors or modulators directed to such MAP Collaboration Target for Therapeutic Use and Diagnostic Use.

For the Option for Non-MAP Collaboration Targets, Licensor grants an exclusive Option to obtain an exclusive license, and a non-exclusive license for up to seven Non-MAP Nominated Targets at any one time.

License Property

Collaboration Model means
—   INK4A-/-/kRAS Spontaneous Inducible Breast Cancer Model
—   INK4A-/-/HER2 Spontaneous Inducible Breast Cancer Model
—   INK4A-/-/kRAS Spontaneous Inducible Lung Cancer Model.

Product means any preparation in final form, either for sale by prescription, over-the-counter or any other method or for administration to human patients in Clinical Trials, for any and all uses in the Field, which preparation contains a Collaboration Compound, or in the case of a Product for Diagnostic Use, utilizes the relevant Discovery Target and/or Collaboration Compound for Diagnostic Use.

Human Response Platform is a novel method of building preclinical models of human cancer, which are intended to more accurately represent cancer biology in patients.

Human Response Prediction platform is based on AVEO's proprietary, genetically-defined mouse models of human cancer. Each of these models is engineered to contain signature genetic mutations that are present in human disease. Beyond these cancer-initiating engineered mutations, the resultant tumors acquire common and distinct spontaneous mutations during tumor progression, providing additional natural genetic variation more akin to the range of genetic heterogeneity encountered across different primary human tumors. The tumor-to-tumor genetic variation in the system provides the opportunity to identify genetic correlations between responding and non- responding tumor populations, and to apply such genetic profiles in clinical development.

Field of Use

Human Response Platform provides an unique insights into cancer biology and mechanisms of drug response and resistance, and represents a significant improvement over traditional approaches.  The parties will use the Human Response Prediction platform to identify patient populations likely to be responsive to a number of investigational cancer drugs currently being developed.  The collaboration is focused on identifying genetic profiles that correlate with drug response to more effectively guide the clinical and market development of Licensee's cancer compounds.

Field means the use of Non-MAP Collaboration Targets, MAP Collaboration Targets, Discovery Targets, Collaboration Compounds and/or Products for any and all Therapeutic Uses and/or Diagnostic Uses.