Royalty Report: Drugs, Biotechnology, Antibody – Collection: 28254

License Grant

The Swiss Licensor grants to Licensee a world-wide non-exclusive licence, with the right to sublicense, under the System Know-How and Patent Rights to use, develop, manufacture, market, sell, offer for sale, distribute, import and export momoclonial antibody Product in the Territory.

License Property

“Product” means the GS-CHOK1SV-derived monoclonal antibody PRO 140, of which Licensee is the proprietor, obtained by the expression of any one gene or of any combination of genes by use of the System, or any formulation containing the same.

System means the Licensor's glutamine synthetase gene expression system consisting of the Cell Lines, the Vectors, and the System Know-How, whether used individually or in combination.

Subject Matter: Expression of polypeptides, such as antibodies, in myeloma cell lines
Title: Transformed Myeloma Cell-Line and a Process for the Expression of a Gene Coding for a Eukaryotic Polypeptide Employing Same

Subject Matter: GS Coding sequence
Title: Recombinant DNA which encodes glutamine synthetase

Subject Matter: Expression systems containing a hCMV promoter
Title: Recombinant DNA Expression Vectors

Subject Matter: Operation of glutamine synthetase expression systems in lymphoid cells
Title: Recombinant DNA Methods, Vectors and Host Cells

USA (cont I) 12.06.92 5879936 09.03.16
USA (cont II) 23.01.95 5891693 06.04.16

Field of Use

The Licensee wishes to commercially exploit the Product. Product means the GS-CHOK1SV-derived monoclonal antibody PRO 140, of which Licensee is the proprietor, obtained by the expression of any one gene or of any combination of genes by use of the System, or any formulation containing the same.

The Licensee will use the PRO 140 monoclonal antibody for treatment of HIV, after a recent study found that it suppressed the HIV virus in patients.

License Grant

The English Licensor hereby grants to Licensee a world-wide non-exclusive licence under the Intellectual Property to develop, manufacture, market and sell Product in the Territory, there shall be no right to sublicense the rights granted hereunder.

License Property

US Patents Rights:
5,981,216 – Transformed myeloma cell-line and a process for the expression of a gene coding for a eukaryotic polypeptide employing same
5,770,359 – Recombinant DNA sequences, vectors containing them and method for the use thereof
5,827,739 – Recombinant DNA sequences, vectors containing them and method for the use thereof
5,591,639 – Recombinant DNA expression vectors
5,658,759 – Recombinant DNA expression vectors

Product means a monoclonal antibody to a bacterial cell surface adhesion known as Aurexis(TM) of which Licensee is the proprietor and which is obtained by the expression of any one gene or of any combination of genes by use of the Materials, or any formulation containing the same.

Intellectual Property means Materials Know-How and Patent Rights owned by Licensor or an Affiliate of Licensor and which Licensor has a right to grant herein.

Patent Rights means the patents and applications which Licensor has a right to grant herein short particulars of which are set out hereto and all patents and applications thereof of any kind throughout the world whether national or regional including but without prejudice to the generality of the foregoing, author certificates, inventor certificates, improvement patents, utility certificates and models and certificates of addition and including any divisions, renewals, continuations, continuations in part, extensions of reissue thereof.

Intellectual property and materials relating to the expression of recombinant monoclonal antibodies to bacterial surface proteins for use in the manufacture of Aurexis.

Field of Use

Aurexis is currently being evaluated in a Phase II clinical trial as a first-line therapy, in combination with standard of care antibiotics, to treat serious, life-threatening Staphylococcus aureus, or S. aureus, bloodstream infections in hospitalized patients.

License Grant

The UK University hereby grants to the Licensee:
  (a)  an exclusive license in the Territory under the Licensed Technology to conduct research on, develop and commercialize the Licensed Technology, to manufacture, have manufactured, use and have used, market, sell, have sold, offer for sale, have offered for sale, import and export and have imported and exported the compositions, technology or inventions, and to practice (or practise) the processes or methods that are within or that constitute the Licensed Technology for use in the Field.
  (b)  the right to grant Sublicenses (with the right of such sublicensees to grant further sublicenses).

License Property

Licensor owns or has rights in certain technology regarding vectors and the capturing of genes.

Licensed Technology means Improvements, Inventions, Information and Know-How and Patents.
Patents means :
  (a)  (i)  Patent number 5,767,336 granted in the United States of America entitled 'Gene Trap Vectors Comprising a Type II Transmembrane Domain', issued August 4,
  1998;
   (ii) Patent number 5,789,653 granted in the United States of America entitled 'Secretary Gene Trap', issued June 16, 1998;
   (iii)    Patent number 673,650 granted in Australia entitled 'Novel Vectors and Use Thereof for Capturing Target Genes', issued March 4, 1997

Field of Use

Field means the use of *** in *** biology *** relating to genes in the medical industry.

License Grant

Licensor, a medical research centers, grants an exclusive license under the Licensed Patent Rights in the Licensed Territory to make and have made, to use and have used, to sell and have sold, to offer to sell, and to import any Licensed Products in the Licensed Fields of Use and to practice and have practiced any Licensed Processes in the Licensed Fields of Use.

License Property

The patents and patent applications relate to Modified Adena-Associated Virus Vector Capable of Expression from a Novel Promoter.

Adeno-associated viruses are small viruses that infect humans and some other primate species. They belong to the genus Dependoparvovirus, which in turn belongs to the family Parvoviridae.

Field of Use

The field of use is the development of compositions and methods utilizing Adeno-Associated Viral Vectors embodied in the Licensed Patent Rights which are useful in the treatment and prophylaxis of human and animal diseases, and does not include compositions and methods for the treatment and prophylaxis of cystic fibrosis.

Cystic fibrosis is a hereditary disease that affects the lungs and digestive system. The body produces thick and sticky mucus that can clog the lungs and obstruct the pancreas. Cystic fibrosis (CF) can be life-threatening, and people with the condition tend to have a shorter-than-normal life span.

License Grant

In this related party agreement, the Licensor hereby grants to Licensee a nonexclusive license in the Territory, with the right to sublicense, to use iBioLaunchâ„¢ Technology and iBio Additional Technology to conduct Process Development, Scale-Up, and R&D activities on Pharmaceutical Products in the Territory. Additionally, subject to the terms and conditions of this Agreement, Licensor hereby grants to Licensee a nonexclusive license in the Territory, with the right to sublicense, to use the iBio Additional Technology to conduct Process Development, Scale-Up, and R&D activities on Products in the Territory.

License Property

The patents and technology are for the accelerated discovery and production of improved vaccines, monoclonal antibodies, therapeutic proteins, and other products derived from green plants utilizing its iBioLaunchâ„¢ plant-based platform technology and other proprietary technologies.

7,012,172   VIRUS INDUCED GENE SILENCING IN PLANTS   3/14/2006
          
7,491,509   SYSTEM FOR EXPRESSION OF GENES IN PLANTS   2/17/2009
          
7,683,238   PRODUCTION OF PHARMACEUTICALLY ACTIVE PROTEINS IN SPROUTED SEEDLINGS   3/23/2010
          
7,692,063   PRODUCTION OF FOREIGN NUCLEIC ACIDS AND POLYPEPTIDES IN SPROUT SYSTEMS   4/6/2010
          
8,058,511   SYSTEM FOR EXPRESSION OF GENES IN PLANTS   11/15/2011
          
8,148,608   SYSTEMS AND METHODS FOR CLONAL EXPRESSION IN PLANTS   4/3/2012
          
8,173,408   RECOMBINANT CARRIER MOLECULE FOR EXPRESSION, DELIVERY AND PURIFICATION OF TARGET POLYPEPTIDES   5/8/2012
          
8,591,909   RECOMBINANT CARRIER MOLECULE FOR EXPRESSION, DELIVERY AND PURIFICATION OF TARGET POLYPEPTIDES   11/26/2013
          
8,597,942   SYSTEM FOR EXPRESSION OF GENES IN PLANTS   12/3/2013
          
8,951,791   SYSTEM FOR EXPRESSION OF GENES IN PLANTS   2/10/2015
          
9,012,199   RECOMBINANT CARRIER MOLECULE FOR EXPRESSION, DELIVERY AND PURIFICATION OF TARGET POLYPEPTIDES   4/21/2015

Field of Use

This agreement pertains to the patents and technologies for research, process development and scale-up, and manufacturing of plant-derived products in a manufacturing facility designed for that purpose relating to drugs in the healthcare industry.

License Grant

The Swiss Licensor grants an exclusive option to obtain a non-exclusive, worldwide license, with the right to subl1cense through multiple levels of sublicensees, under the Licensor Patents, Technology and Know-How, any Licensee Cell Lines, and/or any Products, to propagate, have propagated, use, have used, import and have imported any Licensee Cell Lines, make, have made, manufacture, have manufactured, purify and have purified the recombinant antibody derived from the COMPANY Cell Lines, and (iii) research, develop, make, have made, use, have used, sell, have sold, offer for sale, have offered for sale, import and have imported any Products, in the attached License agreement.

Upon the Licensee exercising the Commercial License Option as provided in the Services Agreement, the Swiss Licensor grants to a non-exclusive license Under the Licensor Technology to propagate, have propagated, use, have used, import and have imported Cell Lines, develop, have developed make, have made, manufacture, have manufactured,_ to make, have .made; use, have used, offer for sale, have offered for sale, distribute for sale, have distributed_ for sale, sell, have sold, import, have  Imported Products in the Licensed Field of Use, and otherwise exploit Products, lnciuding the use of products in clinical trials.

License Property

The project is to rapidly develop high-performance clonal cell line(s) for the production of Licensee Product using Licensor Genetic Elementsâ„¢ (SGEs) and SURE Cell Line(s) Development process.

Cell Line shall mean a mammalian cell line.

The patents are Matrix attachment regions and methods for use thereof, and, High Efficiency. Gene Transfer and Expressions in Mammalian Cells by a Multiple Transfection Procedure of MAR sequences.

Field of Use

Licensee is for the development of high-expression production cell lines expressing our h16C3 and 31.1 antibodies

h16C3 is a humanized mAb that we believe recognizes TSAs from pancreatic/colorectal cancers and adenocarcinoma. This monoclonal antibody may increase diagnostic and therapeutic coverage for both colon and pancreatic cancer.

License Grant

The Licensor of England grants to the Licensee the following licenses under the Winter Patent:
– a non-exclusive world-wide license to exploit the Winter Patent commercially in any way whatsoever by the use of the Reshaping Process in the Fields and by the commercial exploitation in the Fields of any resulting antibodies provided always that any such exploitation does not involve the antibodies detailed.
– a non-exclusive sub-license under the Boss Patents to the extent required to enable the licensee to use the Reshaping Process to produce Products from mammalian cells and for no other purpose.

License Property

Licensor has certain patent rights in respect of the genetic engineering of monoclonal antibodies comprising the replacement in whole or in part of the complementarity determining regions of one antibody by those of another.

The Reshaping Process shall mean the genetic engineering of monoclonal antibodies comprising the replacement in whole or in part of the complementarity determining regions of one antibody by those of another as described in the Winter Patent.

The Products shall mean end products produced either directly or indirectly from antibodies which have been modified using the Reshaping Process and which are in a form capable of being marketed or sold upon a commercial basis.

Winter patents relate to Recombinant DNA products and Methods.

Boss patents relate to Multichain Polypeptides or Proteins and Processes for their Production Expression of multichain proteins, such as antibodies, in single hose cells.

Field of Use

The Fields shall mean the field of human therapy or prophylaxis and human in vivo and in vitro diagnostics.

License Grant

Licensor grants Licensee a license for the Derived Products, based on the gross sales of each Derived Product by country.

Licensor hereby grants Licensee an exclusive, royalty-free, fully paid-up, freely sublicensable and transferable, license under the Licensor Co-Formulation Patents for all uses and applications in the Field in the Territory, including to make, have made, use, sell, offer for sale, import, export, manufacture, develop and commercialize products for use in the Field and in the Territory.

Licensor hereby grants Licensee a non-exclusive, royalty-free, fully paid-up, freely sublicensable and transferable, license under the Licensor Vector Patents for all uses and applications in the Field in the Territory, including to make, have made, use, sell, offer for sale, import, export, manufacture, develop and commercialize products for use in the Field and in the Territory.

Licensor hereby grants Licensee an exclusive, royalty-free, fully paid-up, freely sublicensable and transferable, license to the Licensor BOT Know-How for all uses and applications in the Field in the Territory, including to make, have made, use, sell, offer for sale, import, export, manufacture, develop and commercialize products for use in the Field and in the Territory.

Licensor hereby grants Licensee a non-exclusive, royalty-free, fully paid-up, freely sublicensable and transferable, license to the Licensor General Know-How for all uses and applications in the Field in the Territory, including to make, have made, use, sell, offer for sale, import, export, manufacture, develop and commercialize products for use in the Field and in the Territory.

License Property

Derived Product means any product the discovery, manufacture, use, sale, offer for sale or importation of which (i) would, in the absence of ownership of or a license under any of the Licensor Patents or UCSF Licensed Patents, infringe a claim of any of the Licensor Patents or UCSF Licensed Patents, or (ii) involve any Licensor General Know-How or Licensor BOT Know-How.

Co-Formulation Patents means those certain patents and patent applications as set forth, including all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, all letters patent granted thereon, and all reissues, re-examinations and extensions thereof, and all foreign counterparts of any of the foregoing.

UCSF Licensed Patents means the patents and patent applications which are the subject of the Licensor License Agreements.

Vector Patents means those certain patents and patent applications set forth, including all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, all letters patent granted thereon, and all reissues, re-examinations and extensions thereof, and all foreign counterparts of any of the foregoing.

BOT Know-How means all tangible and intangible techniques, information, technology, practices, trade secrets, inventions (other than those disclosed in a Licensor Patent), methods, processes, knowledge, know-how, conclusions, standard operating procedure, test data and results (including pharmacological, toxicological, manufacturing, and clinical test data and results), regulatory documentation, analytical and quality control data, and results or descriptions, in each case (i) owned or controlled by Seller or any of its Affiliates, and (ii) relating directly to the Products, as set forth under the heading, Licensor BOT Know-How.  For the avoidance of doubt, Licensor BOT Know-How includes the Manufacturing Documentation.

General Know-How means all tangible and intangible techniques, information, technology, practices, trade secrets, inventions (other than those disclosed in a Licensor Patent), methods, processes, knowledge, know-how, conclusions, standard operating procedure, test data and results (including pharmacological, toxicological, manufacturing, and clinical test data and results), regulatory documentation, analytical and quality control data, and results or descriptions, in each case (i) owned or controlled by Seller or any of its Affiliates, and (ii) relating directly to the Products, as set forth, under the heading “General Know-How.”

Co-Formulation Patents:   Title: Antibody Co-formulations

Country
                Application    
File Date
Patent/Publication
US Provisional
61/240,155
        9/4/2009

PCT
                        PCT/US10/47753
9/2/2010
WO 2011/028962 A2
US
                        12/875,083
        9/2/2010
20110059079 A1
US Con
                14/705,713
        5/6/2015

Europe

Co-Formulation Patents:  Title:  Anti-Botulism Antibody Coformulations

Country  
        Application    
File Date
Patent/Publication
US Provisional
61/240,149
        4/9/2009

PCT
                        PCT/US10/47752
9/2/2010
WO 2011/028961 A2
US
                        12/875,065
        9/2/2010
8,821,879 B2

Vector Patents:  Title:  Methods and Materials for Transient Expressions of a Recombinant Protein

Country
                Application
           File Date      
Patent/Publication
US Provisional
60/633,056
           12/3/2004

PCT
                        PCT/US05/043922   2/5/2005
        WO 2006/060769
US
                        11/831,691
           7/31/2007    
7,794,976 B2

Vector Patents:   Title:  Methods and Materials for Increasing Expression of Recombinant

Country
                Application                    File Date
Patent/Publication
US Provisional
60/368,530            
3/29/2002

PCT
                        PCT/US03/010154
3/31/2003
WO 04/033693
US
                       10,404,724              
3/31/2003
7,192,737 B2
US
                       11/673,539
                2/9/2007
7,993,915 B2
US
                       13/205,448              
8/8/2011
8,497,096 B2

Field of Use

This agreement pertains to the drug industry.

License Grant

The University or Licensor granted rights to certain patents and technology to the Ireland-based Licensee. The agreement is a royalty-bearing, non-exclusive license under Licensed Subject Matter to manufacture, have manufactured, use, distribute, Sell, offer to Sell, import, lease, loan or otherwise Commercialize Licensed Products in Licensee's ordinary course of business, within the Licensed Territory (worldwide) for use within Licensed Field. This Patent agreement is subsequent to a research agreement from which the relevant technology emerged.

License Property

The Licensed Subject Matter means protein and antibody based inventions. Patent Rights means the University's rights in information or discoveries covered by the University’s patent(s) or patent applications in the Licensed Territory for the following: a.“VMP-Like Sequences of Pathogenic Borrelia”; and b.“VMP-Like Sequences of Pathogenic Borrelia Species and Strains”; and c.any patent(s) issuing from the foregoing applications; and d.any reissue, extension, revival or reexamination of the foregoing patent(s).

Field of Use

The Licensed Field means the use of Licensed Subject Matter to make, have made, use and Sell a protein or antibody-based human diagnostic test for Lyme disease.

License Grant

Licensor grants to Licensee under all Licensors Patents a nonexclusive, worldwide, sublicensable license to the extent necessary to make, have made, use, sell, have sold and import Licensees Licensed Products for the treatment, prophylaxis or diagnosis of any disease or condition in humans and animals; provided, however, that with respect to Licensees Licensed Products containing an Anti-IgE Antibody identified and synthesized before June 1, 1997, and/or Licensors Patents issued before June 1, 1999, the foregoing limitation -to the extent necessary- shall not be applicable.

License Property

Anti-IgE Antibody means an antibody directed against the immunoglobulin IgE as an antigen, fragments or conjugates of such antibodies, and other constructs comprising antibodies which are derived from or contain any of the above-specified components.

Licensees Licensed Product means any pharmaceutical formulation or product or method or system which contains an Anti-IgE Antibody.

Licensors Licensed Product means any pharmaceutical formulation or product or method or system which contains an Anti-IgE Antibody identified and synthesized by Licensor and/or a third party, or other IgE inhibiting antibodies within Licensorss MIGIS(R) program.

Field of Use

The agreement is for antibodies for immunology, infectious diseases and cancer.

License Grant

The Licensor grants the Licensee an exclusive, worldwide royalty-bearing license under the Intellectual Property to manufacture, have manufactured, market, package, warehouse, use ,sell, offer to sell, have sold, distribute, import into the Territory, export and otherwise dispose of Products in the Field of the treatment and prevention of viral infectious diseases in humans.

License Property

The Patent Rights arise from the following:

U.S. Patent No. 5,658,762, entitled “DNA molecules, expression vectors, and host cells expressing antigenized antibodies” issued April 19, 1997.

U.S. Patent Application No. 09/300,959, entitled “STI and related methods” pending.

Field of Use

The Field is the treatment and prevention of viral infectious diseases in humans.

License Grant

Pursuant to this Settlement and Cross-license agreement, Licensor grants to Licensee of Bermuda under all Licensor Patents, on a country-by-country basis in the Licensees Territory, an exclusive, sublicenseable license to make, have made, use, sell, have sold and import Licensees Licensed Products for the treatment, prophylaxis or diagnosis of any disease or condition in humans;  with respect to Licensees Licensed Products containing an Anti-IgE Antibody identified and synthesized before June 1, 1997, and/or Licensors Patents issued before June 1, 1999.

License Property

Anti-IgE Antibody means an antibody directed against the immunoglobulin IgE as an antigen, fragments or conjugates of such antibodies, and other constructs comprising antibodies which are derived from or contain any of the above-specified components.

Licensees Licensed Product means any pharmaceutical formulation or product or method or system which contains an Anti-IgE Antibody.

Licensors Licensed Product means any pharmaceutical formulation or product or method or system which contains an Anti-IgE Antibody identified and synthesized by Licensor and/or a third party, or other IgE inhibiting antibodies within Licensorss MIGIS(R) program.

Field of Use

The agreement is for the drug industry relating to antibodies for immunology, infectious diseases and cancer.

License Grant

The Licensor of England grants a right and license to develop, make, have made, use, offer for sale, sell, have sold, import and export Licensed Products for use in the Field in the Territory.  

The license s exclusive or non-exclusive on a patent by patent basis.

License Property

Licensor has a product, known as Cxx-870, which contains a recombinant humanized pegylated Fab’ antibody fragment which binds to TNF alpha, or Tumor Necrosis Factor? alpha.

Licensed Product means any product that contains or comprises an Antibody, or any chemically modified Antibody, which recognizes TNF alpha. For the avoidance of doubt, Licensed Product shall not include non-Antibody inhibitors of TNF alpha.

The patents are titled Multichain Polypeptides or Proteins and Processes: for their Production;
Recombinant Antibody; Humanized Antibodies; Protein Expression System;  Process for obtaining Antibodies; Monovalent Antibody Fragments;  and, Biological Products.

Field of Use

Field means the prevention, treatment, diagnosis or control of all diseases or conditions in humans or animals; provided, however, that with respect to CDP-571, the Field shall not include the prevention, treatment, diagnosis or control of any diseases or conditions other than rheumatoid arthritis.

IBD Indication means the prevention, treatment or control of Crohn’s Disease and/or ulcerative colitis in humans and/or animals.

RA Indication means the prevention, treatment or control of rheumatoid arthritis in humans.

License Grant

The University hereby grants the Licensee an exclusive worldwide right and license in the Licensed field to practice under the Patent Rights and the Technology Rights and to make, have made, use, offer for sale, sell and import Licensed products or the practice of services utilizing the Licensed Processes. Licensee shall have an exclusive option to license any Invention. Licensee
shall have the right to grant sublicenses consistent with this Agreement.

License Property

United States Patent   7,668,659
Diagnosis and classification of multiple myeloma

United States Patent   7,308,364
Diagnosis of multiple myeloma on gene expression profiling

Field of Use

Licensed Field shall mean those applications of Patent Rights and/or the Technology Rights with respect to non-malignant and malignant human or animal pathologies, including but not limited to, determining and/or identifying the presence, predisposition, effect of treatment, mode or type of treatment, type of patient, susceptibility to treatment or prevention, progress of treatment, current and predicted clinical outcome, and/or therapeutic or prophylactic treatment and/or regimen.

License Grant

The University grants to the Company, (i) an exclusive license under the licensed Patents to develop, manufacture, have made, import, use, sell, have sold, distribute, rent or lease Licensed Products/Services throughout the Territory, together with a right to grand sublicenses.

License Property

Certain patent applications titled Nucleic Acids and Proteins of Insect or 83b odorant receptor genes and uses thereof.” The olfaction intellectual property assets are also referred to herein as “our olfaction intellectual property.

License Grant

Licensee desires to engage Licensor to create certain such cell lines, using the RAGE-VT technology, each of which expresses a specific cell surface or cellular protein of interest to Licensee, and to obtain license rights to use such cell lines for internal research, development and commercialization of pharmaceutical products.

Licensor shall create new Accepted Cell Lines based on RAGE-VT cell lines that Licensee proposes.

For the Research and Development License, and effective upon Licensors acceptance of a particular Accepted Cell Line, other than a Counterscreening Cell Line, Licensor grants to a non-exclusive, worldwide license, without the right to sublicense, under the Licensor Technology solely to use such Accepted Cell Line in the Field.

For the Evaluation License, as to each Collaboration Cell Line provided to Licensee by Licensor, Licensor grants a non-exclusive, worldwide license, without the right to sublicense, under the
Licensor Technology solely to conduct internal research evaluation of such Collaboration Cell Line.

For the Counterscreening License, and effective only upon Licensee s acceptance of a particular Accepted Cell Line that Licensee elected to be a Counterscreening Cell Line, Licensor grants to a non-exclusive, worldwide license, without the right to sublicense, under the Licensor Technology solely to use each such Counterscreening Cell Line for Counterscreening.

License Property

Licensor has technology relating to methods for activating gene or protein expression in cells, referred to by Licensor as the Random Activation of Gene Expression or RAGE technology, which includes the RAGE-VT technology useful for creating cell lines that express particular desired proteins.

Product shall mean any product containing a Candidate Compound, including any formulation, dosage form, packaged form or delivery means thereof.

RAGE Technology shall mean any and all intellectual property, whether or not patentable, that is owned or licensed by Licensor and relates to Licensor techniques for activating gene expression, which are referred to by Licensor collectively as Random Activation of Gene Expression or RAGE technology.

Licensor is a functional genomics and biopharmaceutical company engaged in the development, application and commercialization of novel gene expression tools and therapeutic products.

Field of Use

Field shall mean use of the Accepted Cell Lines by Licensee solely for Licensees internal discovery, research, development and/or commercialization of Products.

License Grant

Library Technology. Licensor hereby grants to Licensee a worldwide, non-exclusive right and license (without any right to grant sublicenses except to Sublicensed Recipients under the terms and under Licensor's rights in the Library Technology, including, without limitation, any Patent Rights Controlled by Licensor Covering the foregoing, (a) to use the OmniBank II Library and Mutant Mice obtained from the Existing OmniBank Library and (b) to make, use and sell Materials derived therefrom. Licensee's right under the foregoing license to sell Materials shall be subject to Cre-Lox Patents.

License Property

Licensor has technology for and expertise in the generation of mouse embryonic stem cell clones containing gene trap mutations that can be used in the production of knockout mice.

Licensor and Licensee are interested in collaborating in the start-up and initial operations of TIGM, including the endowment of TIGM with a library of such mouse embryonic stem cell clones containing gene trap mutations.

'Bioinformatics Software' means the software for the management and analysis of data relating to the OmniBank II Library and the production, genotyping and phenotypic analysis of knockout mice.

The Bioinformatics Software is an online analytical and decision-support system that catalogs the in vivo characterization of all mouse embryonic stem cell clones contained in the OmniBank II Library. Users can assess and search a wide range of phenotypic information at different levels, including raw data, calculated graphs with annotated summaries, and statistical analysis for selected diagnostic areas, by means of a standard web browser. Information can be retrieved through an intuitive search interface by gene description and sequence, disease indication, keywords, related publications and statistical significance.

'Materials' means Mutant Mice, Progeny and cells, tissues and other biological materials derived from any of the foregoing; provided that Materials shall not include cells, tissues or other biological materials that do not contain a Selected Mutation.

'Progeny' means mice, including successive generations thereof, that are produced, developed or derived by or on behalf of TIGM or Sublicensed Recipients directly or indirectly from a Mutant Mouse progenitor.

CRE-LOX PATENTS:
4,959,317

GENE TRAPPING PATENTS:
USA                                6,136,566     10/24/00      10/4/2016
USA                                6,207,371     3/27/01       10/4/2016
PCT        PCT/US98/16373
USA                                6,139,833     10/31/00      8/8/2017
PCT        PCT/US99/06474
USA                                6,080,576     6/27/00       4/8/2018
PCT        PCT/US99/27366
USA                                6,436,707     8/20/02       4/8/2018
USA                                6,776,988     8/17/04       7/26/2019
USA                                6,218,123     4/17/01       8/10/2019
USA                                6,855,545     2/15/05       2/27/2017
USA                                6,808,921     10/26/04      4/18/2018

License Grant

The UK Licensor agrees to grant to the Licensee the following licenses under the Winter Patent:
(i)  a non-exclusive worldwide license to exploit the Winter Patent commercially in any way whatsoever by the use of the Reshaping Process in the Fields and by the commercial exploitation in the Fields of any resulting antibodies provided always that any such exploitation does not involve the antibodies detailed in the agreement hereto; and (ii) a non-exclusive sublicense under the Boss Patents to the extent required to enable the licensee to use the Reshaping Process in accordance with (i) above and for no other purpose.

The Licensee shall not be entitled to grant sublicenses of the rights granted to it under this Agreement except with the prior written consent of Licensor. The licensee shall use its best endeavors to ensure that any sublicensee performs its obligations under any such sublicense.

License Property

The Winter Patent shall mean the patents and applications hereto in this agreement of which Licensor is the proprietor or under which Licensor has the right to grant licenses at the Commencement Date and any divisions, renewals, continuations, extensions or reissues thereof, and any further patent application which names the same Gregory Winter as an inventor and discloses and claims similar subject matter, or which claims the same Convention priority date; and any patent granted or to be granted on such patent application(s). Licensor will promptly notify Licensee of the issuance of any such patents.

The Reshaping Process shall mean the genetic engineering of monoclonal antibodies comprising the  replacement, in whole or in part, of the complementarity determining regions of one antibody by those of another as described in the Winter Patent.

The Boss Patents shall mean
               (i)  European Patent Application 0 120 693 (84301996.9) of 23 March 1984 naming Michael Alan Boss as an inventor;
               (ii) GB Patent Application 8308235 of 25 March 1983;
               (iii) Japanese Patent Application 501609/84 of 23 March 1984;
               (iv) and any patent granted or to be granted on such patent application(s).
               (v)  US Patent 4 816 397 of 28 March 1989.

4,816,397 – Multichain polypeptides or proteins and processes for their production

The Products shall mean products produced either directly or indirectly from antibodies which have been modified using the Reshaping Process and which are in a form capable of being marketed or sold upon a commercial basis (the parties intend that the Products will include in some manner such an antibody).

Field of Use

Fields shall mean the field of human therapy and human in vivo and in vitro diagnostics.

License permits Licensee to humanize our murine monoclonal antibodies.

License Grant

University hereby grants to Licensee and the Covered Affiliates for the term of this Agreement the worldwide right and license, with the right to grant sublicenses, to develop, have developed, make, have made, use, have used, import, have imported, sell, offer for sale and have sold University Licensed Products under the Group 1 Patents in all fields of use. Such right and license shall be non-exclusive to Licensee.

Group 2 License Grant. University hereby grants to Licensee and the Covered Affiliates for the term of this Agreement the worldwide right and license, with the right to grant sublicenses, to develop, have developed, make, have made, use, have used, import, have imported, sell, offer for sale and have sold University Licensed Products under the Group 2 Patents in all fields of use. Such right and license shall be non-exclusive to Licensee in the LSD Field.  Subject to this Agreement, such right and license shall be exclusive to Licensee outside the LSD Field.

University hereby grants to Licensee and the Covered Affiliates for the term of this Agreement the worldwide right and license, with the right to grant sublicenses, to develop, have developed, make, have made, use, have used, import, have imported, sell, offer for sale and have sold University Licensed Products under the Group 3 Patents in in all fields of use.   Subject to this Agreement, such rights and license shall be exclusive to Licensee.

License Property

Group 1 Patents means the following patents:
US 6,475,769 – Methods and cell line useful for production of recombinant adeno-associated viruses
US 7,238,526 – Methods and cell line useful for production of recombinant adeno-associated viruses

Group 2 Patents means the following patents:
US 6,759,237 – Adeno-associated virus serotype 1 nucleic acid sequences, vectors and host cells containing same
US 7,186,552 – Adeno-associated virus serotype 1 nucleic acid sequences, vectors and host cells containing same

Group 3 Patents means
US 7,056,502 – Recombinant aav vectors with AAV5 capsids and AAV5 vectors pseudotyped in heterologous capsids

University Licensed Product(s) means products that in the absence of this Agreement would, where and when made, used, sold, or imported, infringe at least one issued claim or pending claim of University Patent Rights; and products that are made using a process or machine that in the absence of this Agreement would, where and when used, infringe at least one issued claim or pending claim of University Patent Rights. All University Licensed Products intended to deliver the same Gene shall be considered a single University Licensed Product for purposes of this Agreement.

University Patent Rights means those patents and patent applications listed in this Agreement and all foreign counterparts thereof, as well as continuation, continuation-in-part, provided that such continuation-in-part relates directly to existing patents or patent applications and not to any new matter, divisional and re-issue applications
thereof, together with any and all patents issuing thereupon or upon any foreign counterparts thereof; provided, however, that Licensee acknowledge that the invention relating to non-invasive delivery of transgenes into the bloodstream, which is disclosed in Example 6 of International Patent Application No. PCT/USO1/13000 (M2304PCT), and in a US CIP application No. 09/955,444 (N2605), was made at University following termination of the research under the Sponsored Research Agreement.  Licensee hereby acknowledge that they have no rights in this invention relating to non-invasive delivery of transgenes into the bloodstream, as defined in these applications and divisionals, continuations, re-examinations, re-issues, and any foreign counterparts thereof, and any patents issuing therefrom. Licensee agree that they will not make or pursue any claims that this invention as so defined is or should have been part of the University Patent Rights.

Gene means any nucleotide sequence that is capable of encoding, or of causing or modulating the expression of, a proteiin, protein fragment, or other genetic element.  For the purposes hereof, a Gene having 90% homology to that of another Gene, and which expresses essentially the same protein for at least one biological function, shall be considered the same Gene as such other Gene.

LSD Field means the prevention, treatment, or cure of lysosomal storage diseases whether by in vivo or ex vivo means (together with preparation, research, development, and attempts to do the foregoing).

Cancer Field means the prevention, treatment or cure of malignancies whether by in vivo or ex vivo means together with preparation, research, development, and attempts to do the foregoing).

TNFr/Inflammatory Field means the prevention, treatment, or cure of any disease or diseases in whole or in part through use or delivery of the TNFr Gene or any other Gene acting in the Inflammatory Pathway, whether by in vivo or ex vivo means (together with preparation, research, development, and attempts to do the foregoing).

Field of Use

This agreement pertains to the drug industry relating to Gene Therapy.

License Grant

Licensor grants to the Swiss Licensee an exclusive license under the Licensed Technology to develop, manufacture, sell, use, import and export API, Intermediate and Amidating Enzyme in the Territory solely for the purpose of developing, having developed, manufacturing, using, selling, having sold importing and exporting Licensee Drug Products and/or manufacturing and selling API to Licensor for use in Licensor Drug Products, by Licensor its Affiliates, licensees or distributors.

This agreement includes non-exclusive grants back from Licensee to Licensor.

License Property

Know-how and patent rights relate to all cell lines, cell banks, clones, vectors, cassettes, separations, purifications, ideas, inventions, data, instructions, processes (including, without limitation, the process of manufacturing API through a fermentation process or through the employment of an Amidating Enzyme, formulas, expert opinions and information, including, without limitation, biological, chemical, pharmacological, physical and analytical, clinical, safety, manufacturing and quality control data and information, in each case, which are necessary or useful for the development, testing, use, manufacture or sale of API, Amidating Enzyme or Intermediates and which is in the possession of and owned or Controlled by Licensor and/or its Affiliate as applicable.

Amidating Enzyme means a recombinant enzyme used to convert non amidated peptides or proteins to amidated peptides or proteins.

Licensor sole improvements are Improved Bacterial Host Cell For the Direct Expression of Peptides; Recombinant Cell Lines Expressing Alpha-Amidating Enzyme; and,  Improved Conditions For Amidation Of Peptides.

In organic chemistry, peptide synthesis is the production of peptides, compounds where multiple amino acids are linked via amide bonds, also known as peptide bonds. Peptides are chemically synthesized by the condensation reaction of the carboxyl group of one amino acid to the amino group of another.

Field of Use

Field means the use by oral administration of the APl for the prophylactic and/or therapeutic treatment of any human diseases or disorders, including, but not limited to, osteoporosis.