Royalty Report: Drugs, Disease, Antibody – Collection: 299278

License Grant

Licensor shall grant to Irish Licensee and any Licensee Development Partner of whom Licensee provides written notice to Licensor an exclusive, worldwide, royalty-bearing license and right under the Licensor Patent Rights and/or any other patents, patent applications or intellectual property owned or licensed by Licensor (with the right to license or sublicense), which claim or cover a given Licensee Development Product or its manufacture or use to make, have made, use, sell, offer to sell, import, export, develop, commercialize and manufacture such Licensee Development Product. During the pendency of each Licensee Project and for a period of eighteen months (18) thereafter, Licensor covenants that it will not conduct any activities on its own behalf or on behalf of a Third Party which relates to or encompasses the Licensee Target that is the subject of such Licensee Project.

License Property

Antibody Evolution means the alteration of the nucleic acids encoding an Immunoglobulin by saturation mutagenesis as described in the Licensor Patent Rights, by means other than Antibody Phage Display.

Licensor Patent Rights means the inventions patentable under applicable patent law that are claimed in the patent applications and patents listed (a) hereto and all divisions, continuations, continuations-in-part, applications claiming priority thereto, and substitutions thereof; all foreign patent applications corresponding to the preceding applications; all U.S. and foreign patents issuing on any of the preceding applications, including extensions, reissues and re-examinations; and any patents or patent applications, whether now existing or obtained in the future, owned or controlled by Licensor containing a claim that is dominating over the foregoing patent rights (i.e., is necessarily infringed by the practicing of a claim in one of the foregoing applications); and any patents or patent applications covered by any Licensor Third Party Licenses, a list of which is set forth.
6,171,820 – Saturation mutagenesis in directed evolution
6,479,258 – Non-stochastic generation of genetic vaccines

Licensor Evolution Technologies means the inventions patentable under applicable patent law that are claimed in the Licensor Patent Rights which both (a) are owned or controlled by Licensor and (b) either (i) comprise evolution of a gene and/or gene pathway by changing more than 50% of the codons and/or amino acids of such gene and/or genepathway to more than 50% of every other possible codon and/or amino acid or such gene and/or gene pathway, or (ii) comprise evolution of a gene and/or gene pathway by creating and screening a non-stochastically produced library of molecules by combining tragments of a plurality of genes chosen by design to reassemble compleete genes and/or gene pathways according to the patentable methods embodied by inventions described in the Licensor Patent Rights.

Licensed Immunoglobulin means (a) with respect to the licenses and rights granted, any Immunoglobulin discovered, isolated or characterized by Licensor through the use of Antibody Evolution, and (b) with respect to the licenses granted, Licensed Immunoglobulin includes any Immunoglobulin discovered using Antibody Evaluation but outside the Manufacturing Field, and for purposes of this agreement hereof, Licensed Immunoglobulin includes any Immunoglobulin within the Manufacturing Field.

Licensed Immunoglobulin Information means any data, know-how or other information relating, concerning or pertaining to a Licensed Immunoglobulin, including without limitation data, know-how or other information characterizing or constituting such Licensed Immunoglobulins polynucleotide or amino acid sequence, purported function or utility, antigen binding affinity, or physical or biochemical property.

Immunoglobulin means any molecule, including without limitation, full immunoglobulin molecules (e.g., IgG, IgM, IgE, IgA and IgD molecules) and ScFv, Fv and Fab molecules, that has an amino acid sequence by virtue of which it specifically interacts with an antigen and wherein that amino acid sequence consists essentially of a functionally operating region of an antibody variable region including without limitation any naturally occurring or recombinant form of such a molecule.

Licensee Patent Rights means the inventions patentable under applicable patent law that are claimed in the patent applications and patents listed hereto and all divisions, continuations, continuations-in-part, applications claiming priority thereto, and substitutions thereof; all foreign patent applications corresponding to the preceding applications; all U.S. and foreign patents issuing on any of the preceding applications, including extensions, reissues and re-examinations; and any patents or patent applications, whether now existing or obtained in the future, owned or controlled by Licensee containing a claim that is dominating over the foregoing patent rights (i.e., is necessarily infringed by the practicing of a claim in one of the foregoing applications).
5,595,898 – Modular assembly of antibody genes, antibodies prepared thereby and use
6,204,023 – Modular assembly of antibody genes, antibodies prepared thereby and use

Licensee Technology Platform means all know-how, trade secrets, inventions, data, processes, procedures, devices, methods, formulas, media and all cell lines, reagents, protocols and other information, whether or not patentable, that either (a) constitute or relate to any biological target, antigen, receptor, cell, expression vector, disease, condition, nucleic acid, protein (including, without limitation, an Immunoglobulin) or protein-conjugate which is the subject of or arises out of any Licensee Project or (b) relate to the discovery, optimization, expression or manufacture of Immunoglobulins, in each case which are owned by or licensed to Licensee as of the Effective Date and are disclosed to Licensor or used by Licensor or Licensee in connection with a Licensee Project. For the avoidance of doubt, the term 'Licensee Platform Technology' shall include any prokaryotic expression technology and methods and/or antibody phage display technology and methods.

Licensor Collaborator means any person or entity on whose behalf Licensor engages in Antibody Evolution and/or a person or entity who is the intended recipient of Licensed Immunoglobulins or Licensed Immunoglobulin Information transferred from Licensor.

Licensee Development Product means any composition of matter or article of manufacture consisting essentially of an Immunoglobulin or protein discovered or optimized by Licensor for Licensee pursuant to a Licensor Action Plan and where such Immunoglobulin or protein was discovered or optimized using techniques, methods or materials covered by one or more Valid Claims of any patent or patent application controlled by Licensor, including the Licensor Patent Rights.

Field of Use

The collaborative agreement is to develop optimized therapeutic antibodies.

Licensor Field means (a) Research and Development and (b) the diagnosis, treatment, prevention or prophylaxis of any human or animal condition or disease. The Licensor Field shall not include any Non-Approved Uses.

Manufacturing Field means the production in prokaryotes of an Immunoglobulin for the treatment, diagnosis or prophylaxis of a human or animal disease or condition in quantities which exceed Research Quantities, and shall include commercial, industrial or clinical scale production.

License Grant

Irish Licensor hereby grants to Licensee, a worldwide, non-exclusive, non-transferable license, without any right to sublicense, under the Licensor Patent Rights and the Licensor Know-How within the Licensee Field:
(a) solely on its own behalf, on behalf of any Development Partner of Licensee and on behalf of any Licensee Collaborator, to engage in Antibody Evolution; and (b) solely on its own behalf, on behalf of any Development Partner of Licensee and on behalf of any Licensee Collaborator, to make or have made Research Quantities of a Licensed Immunoglobulin; and (c) solely on its own behalf, to transfer Research Quantities of a  Licensed Immunoglobulin or Licensed Immunoglobulin Information to any Licensee Collaborator or a Development Partner of Licensee; and (d) solely on its own behalf and on behalf of any Licensee Collaborator, to sell, offer to sell, import and export Licensed Immunoglobulins; and (e) solely on its own behalf, on behalf of any Development Partner of Licensee and on behalf of any Licensee Collaborator, to use Licensed Immunoglobulins.

License Property

Antibody Evolution means the alteration of the nucleic acids encoding an Immunoglobulin by saturation mutagenesis as described in the Licensee Patent Rights, by means other than Antibody Phage Display.

Licensor Patent Rights means the inventions patentable under applicable patent law that are claimed in the patent applications and patents listed hereto and all divisions, continuations, continuations-in-part, applications claiming priority thereto, and substitutions thereof; all foreign patent applications corresponding to the preceding applications; all U.S. and foreign patents issuing on any of the preceding applications, including extensions, reissues and re-examinations; and any patents or patent applications, whether now existing or obtained in the future, owned or controlled by Licensor containing a claim that is dominating over the foregoing patent rights (i.e., is necessarily infringed by the practicing of a claim in one of the foregoing applications).
5,595,898 – Modular assembly of antibody genes, antibodies prepared thereby and use
6,204,023 – Modular assembly of antibody genes, antibodies prepared thereby and use

Licensor Technology Platform means all know-how, trade secrets, inventions, data, processes, procedures, devices, methods, formulas, media and all cell lines, reagents, protocols and other information, whether or not patentable, that either (a) constitute or relate to any biological target, antigen, receptor, cell, expression vector, disease, condition, nucleic acid, protein (including, without limitation, an Immunoglobulin) or protein-conjugate which is the subject of or arises out of any Licensor Project or (b) relate to the discovery, optimization, expression or manufacture of Immunoglobulins, in each case which are owned by or licensed to Licensor as of the Effective Date and are disclosed to Licensee or used by Licensee or Licensor in connection with a Licensor Project. For the avoidance of doubt, the term 'Licensor Platform Technology' shall include any prokaryotic expression technology and methods and/or antibody phage display technology and methods.

Licensee Collaborator means any person or entity on whose behalf Licensee in Antibody Evolution and/or a person or entity who is the intended recipient of Licensed Immunoglobulins or Licensed Immunoglobulin Information transferred from Licensee.

Licensor Development Product means any composition of matter or article of manufacture consisting essentially of an Immunoglobulin or protein discovered or optimized by Licensee for Licensor pursuant to a Licensee Action Plan and where such Immunoglobulin or protein was discovered or optimized using techniques, methods or materials covered by one or more Valid Claims of any patent or patent application controlled by Licensee, including the Licensee Patent Rights.

Licensee Patent Rights means the inventions patentable under applicable patent law that are claimed in the patent applications and patents listed (a) hereto and all divisions, continuations, continuations-in-part, applications claiming priority thereto, and substitutions thereof; all foreign patent applications corresponding to the preceding applications; all U.S. and foreign patents issuing on any of the preceding applications, including extensions, reissues and re-examinations; and any patents or patent applications, whether now existing or obtained in the future, owned or controlled by Licensee containing a claim that is dominating over the foregoing patent rights (i.e., is necessarily infringed by the practicing of a claim in one of the foregoing applications); and any patents or patent applications covered by any Licensee Third Party Licenses, a list of which is set forth.
6,171,820 – Saturation mutagenesis in directed evolution
6,479,258 – Non-stochastic generation of genetic vaccines

Licensee Evolution Technologies means the inventions patentable under applicable patent law that are claimed in the Licensee Patent Rights which both (a) are owned or controlled by Licensee and (b) either (i) comprise evolution of a gene and/or gene pathway by changing more than 50% of the codons and/or amino acids of such gene and/or genepathway to more than 50% of every other possible codon and/or amino acid or such gene and/or gene pathway, or (ii) comprise evolution of a gene and/or gene pathway by creating and screening a non-stochastically produced library of molecules by combining tragments of a plurality of genes chosen by design to reassemble compleete genes and/or gene pathways according to the patentable methods embodied by inventions described in the Licensee Patent Rights.

Licensed Immunoglobulin means (a) with respect to the licenses and rights granted, any Immunoglobulin discovered, isolated or characterized by Licensee through the use of Antibody Evolution, and (b) with respect to the licenses granted, Licensed Immunoglobulin includes any Immunoglobulin discovered using Antibody Evaluation but outside the Manufacturing Field, and for purposes of this agreement hereof, Licensed Immunoglobulin includes any Immunoglobulin within the Manufacturing Field.

Licensed Immunoglobulin Information means any data, know-how or other information relating, concerning or pertaining to a Licensed Immunoglobulin, including without limitation data, know-how or other information characterizing or constituting such Licensed Immunoglobulins polynucleotide or amino acid sequence, purported function or utility, antigen binding affinity, or physical or biochemical property.

Immunoglobulin means any molecule, including without limitation, full immunoglobulin molecules (e.g., IgG, IgM, IgE, IgA and IgD molecules) and ScFv, Fv and Fab molecules, that has an amino acid sequence by virtue of which it specifically interacts with an antigen and wherein that amino acid sequence consists essentially of a functionally operating region of an antibody variable region including without limitation any naturally occurring or recombinant form of such a molecule.

Field of Use

Licensee Field means (a) Research and Development and (b) the diagnosis, treatment, prevention or prophylaxis of any human or animal condition or disease. The Licensee Field shall not include any Non-Approved Uses.

Manufacturing Field means the production in prokaryotes of an Immunoglobulin for the treatment, diagnosis or prophylaxis of a human or animal disease or condition in quantities which exceed Research Quantities, and shall include commercial, industrial or clinical scale production.

License Grant

The Irish Licensor hereby grants to Licensee a worldwide, non-exclusive, non-transferable license, without any right to sublicense, under the Licensor Patent Rights and the Licensor Know-How to: (a) on its own behalf and on behalf of a Licensee Development Partner or Licensee Collaborator, make or have made Licensed Antibody Phage Display Materials; (b) on its own behalf and on behalf of a Licensee Collaborator, transfer Licensed Antibody Phage Display Materials; (c) on its own behalf and on behalf of a Licensee Development Partner or Licensee Collaborator, conduct Antibody Phage Display to identify and isolate Licensed Immunoglobulin; (d) on its own behalf and on behalf of a Licensee Development Partner or Licensee Collaborator, use the Licensor Expression Technology in connection with the use of Licensed Antibody Phage Display Materials to make or have made Research Quantities of Licensed Immunoglobulin; (e) on its own behalf and on behalf of a Licensee Development Partner or Licensee Collaborator, use Licensed Immunoglobulin or Licensed Immunoglobulin Information to research and develop, make, have made, use, offer for sale, sell and have sold, import and have imported Products for use in the treatment, prophylaxis, diagnosis or monitoring of a human disease state or condition; and (f) on its own behalf and on behalf of a Licensee Development Partner, to make, have made, use, offer for sale, sell and have sold, import and have imported Products for use in the treatment, prophylaxis, diagnosis or monitoring of a human disease state or condition.

License Property

Licensor Patent Rights means the patent applications and patents listed hereto and, solely to the extent any Valid Claim would cover or be included in the license grants provided for herein, all divisions, continuations, continuations-in-part, applications claiming priority thereto, and substitutions thereof; all foreign patent applications corresponding to the preceding applications; all U.S. and foreign patents issuing on any of the preceding applications, including extensions, reissues and re-examinations; and any other patent rights owned by Licensor which Licensor has the right to license or sublicense and which would be infringed by the activities contemplated hereunder but for this Agreement. Licensor Patent Rights shall also include (i) any improvements of the foregoing that are owned or controlled by Licensor and (ii) any patents or patent applications, whether now existing or obtained in the future, owned or controlled by Licensor containing a claim that is dominating over the foregoing patent rights (i.e., is necessarily infringed by the practicing of a claim in one of the foregoing applications).

5,618,920 – Modular assembly of antibody genes, antibodies prepared thereby and use
5,028,530 – AraB promoters and method of producing polypeptides, including cecropins, by microbiological techniques
5,846,818 – Pectate lyase signal sequence

Licensed Antibody Phage Display Materials means (i) any collection or library of polynucleotide sequences, created by and under the exclusive control of Licensee, which encodes at least one Immunoglobulin and which is contained in filamentous bacteriophage and/or bacteriophage or phagemid cloning vectors capable of propagation in bacteria; or (ii) any collection or library of bacteriophage, created by or under the exclusive control of Licensee, wherein an Immunoglobulin is expressed as a fusion protein comprising an Immunoglobulin or at least a functionally operating region of an antibody variable region and an outer surface polypeptide of a bacteriophage. For the avoidance of doubt, and without expanding the definition thereof, specifically excluded from the definition of Licensed Antibody Phage Display Materials are (x) any article of manufacture or composition of matter suitable for display, expression or secretion of an Immunoglobulin in or from any organism or system other than bacteria and (y) any materials or composition of matter otherwise meeting the definition of Licensed Antibody Phage Display Materials but created by or under the control of any entity, other than Licensee, engaged in a Commercial Antibody Phage Display Business; provided, that, notwithstanding the foregoing, any materials or composition of matter otherwise meeting the definition of Licensed Antibody Phage Display Materials but created by or under the exclusive control of a Licensee Collaborator shall constitute Licensed Antibody Phage Display Materials, but only to the extent derived by such Licensee Collaborator exclusively from Licensed Antibody Phage Display Materials created by or under the exclusive control of Licensee and properly transferred by Licensee to such Licensee Collaborator in accordance with the applicable provisions of this Agreement and such Licensee Collaborator acknowledges that the transfer restrictions and other provisions hereof apply thereto.

Licensed Immunoglobulin means any Immunoglobulin discovered, isolated or characterized by Licensee or a Licensee Collaborator (as defined above) through the use of Licensed Antibody Phage Display Materials.

Licensed Immunoglobulin Information means any data, know-how or other information relating, concerning or pertaining to a Licensed Immunoglobulin, including, without limitation, data, know-how or other information characterizing or constituting such Licensed Immunoglobulin’s polynucleotide or amino acid sequence, purported function or utility, antigen binding affinity, or physical or biochemical property.

Immunoglobulin means any molecule, including without limitation, full immunoglobulin molecules (e.g., IgG, IgM, IgE, IgA and IgD molecules) and ScFv, Fv and Fab molecules, that has an amino acid sequence by virtue of which it specifically interacts with an antigen and wherein that amino acid sequence consists essentially of a functionally operating region of an antibody variable region including, without limitation, any naturally occurring or recombinant form of such a molecule.

Licensee Collaborator means any person or entity who is an authorized end-user of Licensed Antibody Phage Display Materials, the intended recipient of Licensed Immunoglobulins or Licensed Immunoglobulin Information transferred from Licensee and/or a person or entity on whose behalf Licensee knowingly engages in Antibody Phage Display.

Development Partner means a Third Party from whom a party either in- licenses a target for development and/or commercialization by the in-licensing party or with whom a party shares the economic risk of development or commercialization of a target or product being developed or commercialized on behalf of the applicable party.

Field of Use

Licensee has installed commercially available phage display libraries for the discovery of antibodies and are utilizing Licensor's proprietary libraries to enhance our antibody technology platform.

License Grant

Licensor is willing to grant to the Irish Licensee, a co-exclusive license under the GSSM Technologies, in order to permit Licensee, its Development Partners and Collaborators to engage in certain research, development and commercial activities in return for Licensor being released from its obligations under the Existing Agreement to initiate and undertake a scientific collaboration with Licensee with respect to any Remaining Licensee Projects.

Licensor grants to the Irish Licensee a world-wide, co-exclusive license under the Licensor Know-How and Patent Rights to use and practice the GSSM Technologies, on its own behalf and on behalf of any Affiliate, Development Partner or Collaborator, to discover, isolate, optimize, develop or commercialize any Immunoglobulin, including without limitation an Improved Immunoglobulin, or Product in the Field.

License Property

The license is for access to its proprietary Gene Site Saturation Mutagenesis(tm) (GSSM(tm)) technology.  GSSM(tm) is a protein optimization technology that can be used to rapidly engineer antibody variants with enhanced functionality and high binding affinity.

GSSM Technologies means the inventions patentable under applicable patent law that are claimed in the Licensor Patent Rights and the Licensor Know-How.

The patents cover Saturation Mutagenesis in Directed Evolution and End Selection in Directed Evolution.

Licensors know-how includes:
1. Vector for expression of Fabs generated via GSSM
2. Oligonucle tide Design Program
3. QC Program for Sequence Analysis
4. Process Work Flow for Sequence 1st Approach (mid-level overview).
5. GSSM Data Analysis Tool Spreadsheet
6. Eppimotion Protocols and Scripts for GSSM Reactions and Transformations
7. Protocols for High Throughput Process for screening Fabs generated by GSSM
8. Protocols for Performing GSSM on lmmunoglobulins

The Product means any composition of matter or article of manufacture, including without limitation any diagnostic, prophylactic or therapeutic product, which contains or comprises any Improved Immunoglobulin.

Field of Use

The Field means use of an Immunoglobulin or product containing or comprising any Immunoglobulin for the diagnosis, treatment, prevention or prophylaxis of any human or animal condition or disease, and all Research and Development activities relating thereto.  The term Field shall exclude all other uses.

Licensee will have the exclusive right to use GSSM(tm) for the discovery and development of therapeutic antibodies for its internal pipeline projects.

License Grant

The Irish Licensor grants to the Licensee of England a worldwide, non-exclusive, non-transferable license, solely on its own behalf and on behalf of any Licensee Collaborator, without any right to sublicense, under the Licensor Patent Rights to:
(a) Make or have made Licensed Antibody Phage Display Materials;
(b) Solely for Research and Development purposes, conduct Antibody Phage Display;
(c) Make or have made Research Quantities of a Licensed Immunoglobulin;
(d) Transfer Antibody Phage Display Materials, Research Quantities of a Licensed Immunoglobulin or Licensed Immunoglobulin Information to a Licensee Collaborator; and
( e) Use, sell, offer to sell, import and export Licensed Immunoglobulins.

License Property

The patents include Modular Assembly of Antibody Genes, Antibodies Prepared Thereby and Use, and, Modular Assembly of Antibody Genes, Antibodies, and, Novel Plasmid Vector with Pectate Lyase Signal Sequence.

Antibody Phage Display means the authorized use of Licensed Antibody Phage Display Materials to conduct Research and Development.

Licensed Antibody Phage Display Materials means any collection or library of polynucleotide sequences, including without limitation a Licensee Library, created by Licensee and under the exclusive control of Licensee, which encodes at least one Immunoglobulin and which is contained in filamentous bacteriophage and/or bacteriophage or phagemid cloning vectors capable of propagation in bacteria; or any collection or library of bacteriophage, including without limitation a Licensee Library, created by or under the exclusive control of Licensee, wherein an Immunoglobulin is expressed as a fusion protein comprising an Immunoglobulin and an outer surface polypeptide of a bacteriophage.

Licensed Immunoglobulin means any Immunoglobulin discovered, isolated or characterized by Licensee or a Licensee Collaborator through the use of Licensed Antibody Phage Display Materials.

Field of Use

The field is antibody drug discovery.

License Grant

The Irish Licensor hereby grants to the Company a worldwide, non-exclusive, non-transferable license, without any right to sublicense, under the Irish Licensor's Patent Rights and Know-How to:
(a) make or have made Licensed Antibody Phage Display Materials;
(b) solely for Research and Development purposes, conduct Antibody Phage Display;
(c) make or have made Research Quantities of a Licensed Immunoglobulin;
(d) transfer Antibody Phage Display Materials;
(e) transfer Research Quantities of a Licensed Immunoglobulin or Licensed Immunoglobulin Information to a Company Collaborator or a Development Partner of the Company;
(f) sell, offer to sell, import and export Licensed Immunoglobulins;
(g) use Licensed Immunoglobulins; and
(h) use, offer for sale, sell, import and export Products for use in the treatment, prophylaxis, diagnosis or monitoring of a human disease state or condition.

The Company is willing to grant the Irish Licensor non-exclusive licenses, in order to permit the Irish Licensor to engage in certain research, development and commercial activities.

License Property

The Company's patented phage display technology rapidly selects antibodies, peptides and small proteins that bind with high affinity and specificity to therapeutic targets.

Licensed antibody phage display materials means any collection or library of polynucleotide sequences which encodes at least one Immunoglobulin and which is contained in filamentous bacteriophage and/or bacteriophage or phagemid cloning vectors capable of propagation in bacteria; or any collection or library of bacteriophage wherein an Immunoglobulin is expressed as a fusion protein comprising an Immunoglobulin or at least a functionally operating region of an antibody variable region and an outer surface polypeptide of a bacteriophage.

License Grant

Licensor grants the Japanese Licensee an exclusive non-transferable license and/or right, without the right to grant sublicenses, to use Licensor delivered pursuant to Licensee to identify, isolate, modify and develop Discovery Products; and a non-exclusive, non-transferable license and/or right, without the right to grant sublicenses.

License Property

Licensor is engaged in the research and development of product candidates, including without limitation vaccine, Antibodies and blood plasma products, for use in treating and/or preventing human diseases.

The Licensed Product means an Antibody or Antibody Product that is either a Discovery Product or a TAE-Only Product.

Antibody shall mean any molecule, including full immunoglobulin molecules (e.g., IgG, IgM, IgE, IgA and IgD molecules) and ScFv, Fv and Fab molecules, that has an amino acid sequence by virtue of which it specifically interacts with an antigen, immunogen or hapten or which elicits an immune response and wherein that amino acid sequence consists essentially of a functionally operating region of an antibody variable region, including any naturally occurring or recombinant form of such a molecule.

Antibody Product means any composition of matter or article of manufacture consisting essentially of an Antibody alone or integrally associated with a composition of matter or article of manufacture (including without limitation conjugates bound to a toxin, label or other moiety) providing therapeutic, half-life, safety or other advantages to the Antibody.

Field of Use

The Field means the discovery, research, development, manufacture and/or commercialization of Licensed Products for the treatment, palliation or prevention of any disease or condition in humans.

License Grant

Licensor hereby grants to Licensee (a) through the period and subject to the limitation on the number of Antigens provided, the right to receive for each Antigen designated by Licensee, a nonexclusive, worldwide (except as provided in this license under the Licensor Licensed Patents to make, have made, use, import, offer to sell and sell Antibodies pursuant to a Licensor License Agreement.  This right shall not extend to the Licensor Named Antigens.  The rights of Licensee under the Licensor License Agreements shall include the right to grant sublicenses for Antibodies in accordance with the terms of the applicable Licensor License Agreement.  Each license elected by Licensee hereunder shall be pursuant to a separate Licensor License Agreement and effective as of the date of execution by both parties.

License Property

Licensor Licensed Product means an Antibody with respect to which Licensor either has significant marketing rights or has done significant development (e.g., created, humanized or conducted preclinical or clinical development), the manufacture, import, use, sale or offer to sell of which would infringe, if not licensed under this Agreement, one or more claims of a Licensee Licensed Patent which have neither expired or have been disclaimed nor have been held invalid or unenforceable by a court or other body of competent jurisdiction from which no appeal has been or may be taken.

Antigen means a target molecule, usually a protein, to which an Antibody specifically binds and includes all epitopes on that target molecule.

Antibody means any antibody directed against an Antigen and shall include, without limitation, monospecific and bispecific antibodies (but a separate license shall be required for the antigen involved for each arm of  a bispecific antibody); less than full-length antibody forms such as Fv, Fab, and F(ab)2; single-chain antibodies; and antibody conjugates bound to a toxin, label or other moiety.  The term 'Antibody' shall include any and all such constructs directed against any particular Antigen.

Licensee Licensed Patents mean the following patents and patent applications known generally as the Cabilly patents and patent applications:
(a) U.S. Patent No. 4,816,567 and the claims relating to chimeric antibodies found in patents or patent applications arising from divisionals, continuations or continuations-in-part of any application from which U.S. Patent No. 4,816,567 claims priority or any substitute applications therefor, any patent issued with respect to any such patent
application, any reissue, extension or patent term extension of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent  as well as the foreign counterparts of the foregoing and any and all reissues, reexaminations or extensions of the foregoing (but in any event excluding U.S.S.N. 07/205,419 and foreign counterparts thereof) ('Chimera Patents') and (b)  any patent issuing based on U.S.S.N. 07/205,419 (a continuation of the application maturing into U.S. Patent No. 4,816,567) relating to the
coexpression of immunoglobulin chains in recombinant host cells, as well as the divisionals, continuations or continuations-in-part of such U.S.S.N. 07/205,419, the issued foreign counterparts of such U.S.S.N. 07/205,419 and
any and all reissues, reexaminations or extensions or patent term extension of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent ('Coexpression Patents').
4,816,567 – Recombinant immunoglobin preparations

Licensor Licensed Patents means the patents and patent applications identified and including any applications filed as of the Effective Date in the United States or any foreign jurisdiction.  Licensed Patents shall include U.S. or foreign patents or patent applications which claim priority to any application to which a listed U.S. patent also claims priority.  Licensor Licensed Patents shall also include any foreign equivalents, addition, continuation, continuation-in-part or division of such patents or patent applications or any substitute applications therefor, any patent issued with respect to any such patent application, any reissue, extension or patent term extension of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent.  

5,693,089 – Method of collapsing an implantable appliance
5,693,761 – Polynucleotides encoding improved humanized immunoglobulins
5,693,762 – Humanized immunoglobulins

Field of Use

This agreement pertains to the drug industry.

License Grant

For the Research the German Licensor grants a non-exclusive research license under Licensor Background Inventions and Licensors rights in Collaboration Data, Collaboration Materials and Collaboration Inventions, to perform its obligations under the Collaboration Plan.

For the Commercial License,  Licensor grants an exclusive, worldwide license to make, have made, use, have used, sell, have sold, offer for sale, import and have imported Licensed Products for use in the Field directed to such Licensee Target under Licensor Background Inventions, and under Licensors rights in all Patent Rights and Collaboration Inventions and Collaboration Material pertaining to such Licensee Target and Licensed Products, or the uses thereof in the Field.

License Property

Licensors HuCAL Technologies shall mean the HuCAL library and associated technologies.   The library data is for a Design of Human Combinatorial Antibody Library-Fab (HuCAL-Fab).

Field of Use

The field shall mean all therapeutic indications.  With this agreement, the Parties will collaborate in the discovery and development of human monoclonal antibodies against certain specified Licensee Targets,  to generate and characterize antibodies and optimize those antibodies and  use their expertise in developing antibodies in pre-clinical and clinical settings.

The two companies will collaborate on the development of human antibodies for the treatment of cancer.

License Grant

Licensor is granting a non-exclusive license under the Queen Patents for the purpose of conducting research, development and commercial activities on humanized antibodies directed against up to three Licensee Antigens.

For the License Grant, Licensor grants a nonexclusive, non-sublicensable, sublicense under the exclusive rights granted to Licensor herein to research, develop, make and use (but not to, have made, sell, or offer for sale) Licensed Biologic Products for Licensee internal research only.

Licenses to Licensee Under the Queen Patents:
Licensor grants through the fifth anniversary of the Effective Date the right, upon written notice to Licensor, to receive licenses under the Licensor Antibody Humanization Patent Rights for the Licensee Antigens. Licensee shall identify each Licensee Antigen prior to IND Filing for the associated Licensed Queen Product. Each license shall be a nonexclusive, worldwide, transferable, license under the Licensor Antibody Humanization Patent Rights to make, have made, use, import, offer for sale and sell or otherwise dispose of Licensed Queen Product pursuant to a Licensor License Agreement to be executed by the Parties after such written notice.

License Property

Licensor has certain patents and patent applications concerning humanized antibodies and antibody humanization technology including certain patents and patent applications that are sometimes referred to as the Queen Patents.

Licensor Antigens shall mean an antigen selected by Licensee and approved by Licensor for the grant by Licensor to Licensee of a license to its Licensor Antibody Humanization Patent Rights, up to a limit of three antigens. Licensee shall identify each such Licensee Antigen after the Effective Date, but no later than the IND filing date for each associated Licensed Queen Product.

Licensed Queen Products shall mean any Antibody that binds to an Licensee Antigen whose development, manufacture, import, export, use, offer for sale or sale would infringe a Valid Queen Claim absent a license to one or more of the Queen Patents.

Field of Use

Therapeutic Field shall mean any human and/or animal use.

Diagnostic Field shall mean any use for the diagnosis, prognosis, or monitoring of a human disease or disorder.

License Grant

The Licensor, of England, desires to grant to the Licensee, of Germany, a license on a non-exclusive basis of the right to use the Licensor Licensed Patents for the purpose of researching, developing and commercializing the MT201 Product and other products in respect of he EpCAM target.

For the research license, the Licensor of England grants to the Licensee of Germany a non-exclusive, worldwide license under the Licensor Licensed Patents and the Licensor Background Know-How to perform research and development activities in the Licensee Research Field.

For the commercialization license, Licensor grants a non-exclusive, worldwide license under the Licensor Licensed Patents and the Licensor Background Know-How to Exploit Licensed Products in the Licensee Licensed Field.

License Property

Licensor is the owner of rights for certain patents and know-how in the field of Antibody Phage Display.

The know-how includes a Training Manual Antibody Phage Display 2002, and, Licensor mammalian expression lgG vectors.

Licensed Product means the MT201 Product and any other product, substance or formulation arising from the EpCAM Target Program, in each case, the Development, manufacture, importation, use or sale of which would, but for the provisions of this Agreement, infringe one or more Valid Claims under the Licensor Licensed Patents, or utilizes the Licensor Background Know-How.

Field of Use

Licensees Licensed Field means the prognosis, diagnosis, prophylaxis or treatment of human diseases or conditions by modulation of the EpCAM Target.

Licensees Research Field means the identification or development of Antibody Products for the prognosis, diagnosis, prophylaxis or treatment of human diseases or conditions by modulation of the EpCAM Target.

The excluded field is the discovery, isolation, characterization, research, development, and/pr commercialization of an Antibody useful for the diagnosis, treatment and/or prevention of one or more of the following disease conditions wherein the primary scientific rationale or activity is neuronal and/or glial mechanisms of action of neuroprotection: neurodegenerative conditions, diabetic neuropathy, pain, spinal cord injury, multiple sclerosis, and, stroke as a disease of the cerebrovasculature.

License Grant

Pursuant to the master agreement, each Antigen will have its unique patent agreement.  Licensor grants to Licensee with respect to four (4) Antigens), the rights upon written notice to receive licenses under the Patent Rights for up to four (4) Antigens designated by Licensee.

Each license shall be a nonexclusive, worldwide license under the Licensors Patent Rights to make, have made, use, import, market, promote, offer for sale and sell or otherwise dispose of Antibodies pursuant to a Licensors License Agreements. The rights of Licensee shall include the right to grant sublicenses for Antibodies in accordance with the terms of the applicable License Agreement.

License Property

The licensed patents are for Humanized Immunoglobulins and Polynucleotides Encoding.

The Antigens are target molecules to which an Antibody specifically binds and includes all epitopes on that target molecule.

The licensed product means an Antibody with respect to which Licensee has either significant marketing rights or has done significant development, including without limitation created, humanized or conducted preclinical or clinical development, the manufacture, import, use, offer to sell or sale of which would infringe, if not licensed under this Agreement, also known as a Valid Claim.

Field of Use

Licensee identifies and develops therapeutic monoclonal antibodies to address significant unmet medical needs in the areas of immunology, infectious diseases and cancer.  Monoclonal antibodies are genetically engineered antibodies that target a specific foreign substance, or antigen.

License Grant

Licensor grants to Swiss Licensee and to Licensee’s Affiliates, during the Commercialization Term, the exclusive (even as to Licensor) right and license under the Licensor Know-How and Licensor Patents to (i) market, promote, and detail Nutley Dac in the Licensee Territory solely for use in Transplant Induction, and (ii) to sell and offer for sale Nutley Dac in the Licensee Territory under the Trademarks. In addition, Licensor grants to Licensee and to Licensee’s Affiliates, the nonexclusive right under the Licensor Know-How and Licensor Patents to make, have made, use and import Nutley Dac, but only to the extent reasonably necessary for Licensee to carry out its rights and obligations under this Second Amended and Restated Worldwide Agreement. Licensee may sublicense the rights and licenses granted to Licensee, subject to Licensor’s written consent, which consent Licensor may not unreasonably withhold. It shall be deemed reasonable for Licensor to withhold consent with respect to sublicense by Licensee of any of the rights or licenses to any other entity that is developing (in at least one Phase II clinical trial with directional human efficacy data), or marketing or selling in a Major Country any product for the treatment of any Autoimmune Indication. Notwithstanding the preceding sentence, Licensee and its Affiliates may use Third Party distributors in accordance with their customary practices. All sublicenses granted by Licensee or its Affiliates of the licenses set forth in this agreement shall automatically terminate at the end of the Commercialization Term.

License Property

Nutley Dac shall mean the FDA-approved form of Daclizumab manufactured at Licensee’s Nutley, New Jersey facility as of the Amendment Effective Date.

Daclizumab shall be deemed to be a Licensed Product, a humanized antibody now known by the generic name daclizumab, which binds to the interleukin-2 receptor (“IL-2R”). Daclizumab means any product that contains humanized anti-Tac (as defined under Field).

Licensed Product means any product, other than an Excluded Product, in the Field, including any Combination Product, the making, importation, use, offer for sale, or sale of which utilizes Licensee Know-How, Licensee Patents, or Joint Inventions or would, in the absence of this Second Amended and Restated Worldwide Agreement, infringe a Valid Claim of a Licensee Patent.

Combination Product means any product containing both an ingredient that causes it to be considered a Licensed Product and one or more other therapeutically active ingredients.

Other Licensed Products means all Licensed Products other than Daclizumab.

Licensor Patents means all patent applications owned or Controlled by Licensor alone or with a Third Party (“Sole Licensor Patents”) and all patent applications resulting from Joint Inventions (“Joint Licensee-Licensor Patents”) Covering Daclizumab, which are filed prior to or during the term of the 1989 Agreements, the 1999 Agreements or this Second Amended and Restated Worldwide Agreement in the United States or any foreign jurisdiction, including any addition, continuation, continuation-in-part or division thereof or any substitute application therefor; any patent issued with respect to such patent application, any reissue, extension or patent term extension of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent; and any other United States or foreign patent or inventor’s certificate covering products in the Field.

Licensor Patent Rights:
Patent No. 5,585,089, “Humanized Immunoglobulins,” issued December 17, 1996.
Patent No. 5,693,761, “Polynucleotides Encoding Improved Humanized Immunoglobulins,” issued December 2, 1997.
Patent No. 5,693,762, “Humanized Immunoglobulins,” issued December 2, 1997.
Patent No. 6,180,370 “Humanized Immunoglobulins and Method of Making the Same”, issued January 30, 2001.

Trademarks means the trademark “Zenapax®,” and all trademark registrations and applications therefor, and all goodwill associated therewith, and all other trademarks owned by Licensee (except for any Licensee housemarks or trade names) and used in connection with the sale or promotion of Nutley Dac in the Licensee Territory.

Licensor Know-How means, except as otherwise set forth, all inventions, discoveries, trade secrets, information, experience, data, formulas, procedures and results in the Field, and improvements thereon, including any information regarding the physical, chemical, biological, toxicological, pharmacological, clinical, and veterinary data, dosage regimens, control assays and specifications of Daclizumab.

Licensee Patents means both the Licensee Owned Patents and the Licensee Controlled Patents.

Licensee Owned Patents means all patent applications owned by Licensee or its Affiliates (“Sole Licensee Patents”) alone or with a Third Party, and all patent applications resulting from Joint Inventions (“Joint Licensee-Licensor Patents”) covering inventions in the Field that are filed prior to or during the term of this Second Amended and Restated Worldwide Agreement in the United States or any foreign jurisdiction, including any addition, continuation, continuation-in-part or division thereof or any substitute application therefor; any patent issued with respect to such patent application, any reissue, extension or patent term extension of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent; and any other United States or foreign patent or inventor’s certificate covering inventions in the Field. Licensee Owned Patents as of the Effective Date are, specifically, those listed.
Serial No. 60/416,302 – Use of IL-2 Receptor Antibodies

Joint Inventions means any inventions in the Field, whether patented or not, that are jointly made during the period beginning on January 31, 1989 and continuing until the end of the Commercialization Term by at least one (1) Licensor employee or person contractually required to assign or license patent rights covering such inventions to Licensor and at least one (1) Licensee-Nutley or Licensee employee or person contractually required to assign or license patent rights covering such inventions to Licensee-Nutley or Licensee.

Field of Use

Field means any humanized or chimeric antibody that binds to IL-2R, where “humanized” means a genetically engineered combination of a substantially human framework region and constant region, and complementarity determining regions from non-human antibodies, and where “chimeric” means a genetically engineered combination of human constant region and non-human variable region. “Antibodies in the Field” means humanized and chimeric antibodies that bind to IL-2R. It is believed that these Antibodies in the Field may be useful for therapeutic, diagnostic, imaging and similar purposes. It is understood that the Field includes, but is not limited to, that certain humanized murine monoclonal antibody prepared against the p55 component of IL-2R (“humanized anti-Tac”). Furthermore, the Field includes, but is not limited to, all improvements relating to humanized anti-Tac, including without limitation modifications in structure introduced by genetic engineering, or by chemical or enzymatic cleavage. Also included within the Field shall be alternate hosts for producing humanized anti-Tac, methods for purification, formulations incorporating humanized anti-Tac, and uses and methods of use for humanized anti-Tac in human medicine.

Daclizumab is a therapeutic humanized monoclonal antibody which was used for the treatment of adults with relapsing forms of multiple sclerosis.

License Grant

For Licensed Biologic Products, Licensor grants an exclusive, sub-licensable, worldwide license to Licensee to research, develop, use, make, have made, sell, offer for sale, import or export any Licensed Biologic Products in the Therapeutic Field.

For Licensed Drug Products, Licensor grants an exclusive, sub-licensable, worldwide license to research, develop, use, make, have made, sell, offer for sale, import or export any Licensed Drug Products in the Therapeutic Field.  Notwithstanding the foregoing, Licensee may sublicense a Licensed Drug Product, provided that Licensee has at least one pending patent claim covering such product.

For Developed Drug Products, Licensor grants a non-exclusive, sub-licensable, worldwide license to research, develop, use, make, have made, sell, offer for sale, import or export any Developed Drug Products in the Therapeutic Field. Notwithstanding the foregoing, Licensee may sublicense a Developed Drug Product, provided that Licensee has at least one pending patent claim covering such product.

For Licensed Diagnostic Products, Licensor grants a non-exclusive, sub-licensable, worldwide license to research, develop, use, make, have made, sell, offer for sale, import or export any Licensed Diagnostic Product in the Diagnostic Field. Licensees right to sublicense a Licensed Diagnostic Product will be limited to applications reasonably determined to be necessary for successful commercialization of the Licensed Biologic Product or Licensed Drug Product and subject to Licensors approval, which will not be unreasonably withheld.

License Property

Licensor has intellectual property related to the receptor to the Tumor necrosis factor-like weak inducer of apoptosis, or Tweak-R.

Tweak-R shall mean the receptor to the tumor necrosis factor like weak inducer of apoptosis, which is the molecule designated CG 17M42 by HGS.

Field of Use

Therapeutic Field shall mean any human and/or animal use.

Diagnostic Field shall mean any use for the diagnosis, prognosis, or monitoring of a human disease or disorder.

License Grant

Licensee may request that Licensor grant a nonexclusive worldwide license under the Licensor Patent Rights for up to two (2) additional antibodies under development by Licensee as of the date hereof.

License Property

The following are patents and patent applications (the Queen Patents) as of the Effective Date filed in certain countries in the world and licensed under the Agreement. The Queen Patents shall expressly include any foreign counterparts thereto filed by Licensor before or during the term of this Agreement.

1. European Patent number 0451216. Queen, Humanized Immunoglobulin and Their Production and Use.

2. U.S. patent divisional applications numbers 08/487,200, 08/477,728,08/474,040 of issued U.S. patent number 5,530,101, Queen, Improved Humanized Immunoglobulin.

3. Japan patent application number 4-503758, Queen, et al. Improved Humanized Immunoglobulin.

4. U.S. Patent No. 5,693,761, Queen, et al. Polynucleotides Encoding Improved Humanized Immunoglobulin, issued December 2, 1997.

5. U.S. Patent No. 5,693,762, Queen, et. a1. Humanized Immunoglobulin, issued December 2, 1997.

Field of Use

The technology a was used in the development of Xolair (omalizumab) for treating allergies and asthma by using anti-immunoglobulin E, or anti-IgE, antibodies capable of blocking IgE, a causative agent of the allergy pathway, thus preventing the onset of disease symptoms.   Xolair is a humanized monoclonal antibody that blocks IgE.  Some abiquitiy remains around the exact nature of the licensing agreement.

License Grant

The Licensor of England grants to Licensee of Germany a nonexclusive, worldwide license under the Licensor Licensed Patents and the Licensor Background Know-How to Exploit Licensed Products in the Field.

License Property

Licensor is a UK-based biotechnology company using its proprietary technologies and capabilities in human monoclonal antibodies for drug discovery and drug development.

Licensed Product means any product, substance or formulation arising from the Target Program, and the Development, manufacture, importation, use or sale of which would but for the provisions of this Agreement infringe one or more Valid Claims under the Licensor Licensed Patents, or which utilizes the Licensor Background Know-How.

The know-how includes Training Manual Antibody Phage Display 2002, and, mammalian expression IgG vectors.

Field of Use

The Field means the prognosis, diagnosis, prophylaxis or treatment of human diseases or conditions by modulation of the Target. Target means the whole or part and natural variants of the granulocyte-macrophage colony stimulating factor (GM-CSF) identified by the SWISS-PROT entry name CSF2_HUMAN and accession number P04141 with the amino acid sequence which is specifically recognized by an Antibody binding to the foregoing.

Licensee obtains the right within the framework of their collaboration to use Licensor’s intellectual property in phage display to create and commercialise novel antibody products against a defined number of targets.

License Grant

Licensee desires Licensor to conduct research with the Mice to generate fully human monoclonal antibodies to certain Antigens.

For the Evaluation License, Licensor grants an exclusive, nontransferable license for the term of the applicable Evaluation Period to use the Collaboration Technology relating to such Antigen solely for the purpose of evaluating whether Licensee shall desire to acquire a commercial license to such Product(s) directed against such Antigen.

For the Option for Commercial Licenses, Licensee shall have an option to obtain a commercial license with respect to Product(s) directed against such Antigen in the Field of Use in all countries of the Territory,

For the Commercial License,  Licensor grants an exclusive, even as to Licensor, license, with the right to sublicense, under the Licensed Technology to make, have made, import, have imported, use, offer for sale and sell Product(s) directed against such Antigen in the Field of Use in the Territory.

For the Research License, Licensee shall have an irrevocable, perpetual, worldwide exclusive research license, without the right to sublicense, to make and use (but not to transfer, sell, lease, offer to sell or lease, or otherwise transfer title to or interest in the Antibody{ies) and Antibody Cell(s) transferred by Licensor to Licensee, and any related Collaboration Technology, including Genetic Material(s) relating specifically and solely to such Antibody(ies) and Antibody Cell(s), in each case, and an irrevocable, perpetual, worldwide non-exclusive research license, without the right to sublicense, to make and use, but not to transfer, sell, lease, offer to sell or lease, or otherwise transfer title to or interest in the Collaboration Technology relating specifically and solely to antibody(ies), antibody cell(s) or genetic material(s) having a binding specificity and affinity for such Antigen, in each case, which is necessary for Licensee to make and use the same for research.

License Property

The patents relate to Transgenic non-human animals capable of producing heterologous antibodies.

The Collaboration Know How shall mean, with respect to each Antigen, any parts or derivatives of the Mice prepared by Licensor in connection with the applicable Immunization and delivered to Licensee, including without limitation, Antibody(ies), Antibody Cell(s), polypeptides, Genetic Material(s) or other biological materials derived directly or indirectly from the Mice delivered to Licensee, all information relating specifically and solely to the foregoing, including without limitation, technical data, protocols and methods and processes with respect to Product(s) directed against such Antigen and, all information relating specifically and solely to antibody(ies), antibody cell(s) or genetic material(s) having a binding specificity and affinity for such Antigen, including without limitation, technical data, protocols and methods and processes.

Product(s) shall mean, with respect to an Antigen, a composition or compositions with each composition comprising one or more Antibody(ies), Antibody Cell(s) or Genetic Material(s).

Licensor is the sole and exclusive owner of certain transgenic Mice useful for the preparation of fully human monoclonal antibodies.

HuMAb -Mouse technology is a transgenic mouse system that creates high-affinity, fully human antibodies instead of mouse antibodies.  Using standard, well proven laboratory techniques, scientists can produce these antibodies in a matter of months.

Bispecific antibodies, which enhance and direct the body's own immune system to fight disease; and immunotoxin  technology.

Field of Use

The Field of Use shall mean all uses of Product(s), including all human therapeutic, prophylactic and diagnostic uses of Product(s).

License Grant

Licensor grants the German Licensee a non-exclusive, worldwide license, under the Licensor Licensed Patents to Exploit Licensed Products other than BiTE Products and BiTE Research Products.

Licensor grants an exclusive, worldwide, perpetual, irrevocable, non-terminable, license, with the right to grant and authorize the grant of sublicenses, under the Licensor Licensed Patents to Exploit any BiTE Products and BiTE Research Products.

License Property

Licensed Product means any SCA Product, Non-Human SCA Product, Research Product, Industrial SCA Product, BiTE Product, or BiTE Research Product, the composition, manufacture, use of which is claimed by one or more Valid Claims of the Consolidated Patent Portfolio.

This additional amendment added patent 5,223,409, entitled Directed evolution of novel binding proteins.

BiTE Product means any composition or formulation consisting of, containing or comprising a bi-specific Single Chain Antibody expressed as a single polypeptide chain, binding to T-cells for the diagnosis, prophylaxis or treatment of human or non-human diseases or conditions, but excluding any BiTE Research Product.

Diagnostic SCA (Single Chain Antibodies) Product means an SCA Product that is under development, approved or used for the diagnosis of human diseases or conditions.

Licensee Pipeline Product means any Licensed Product, other than a BiTE Product or BiTE Research Product, as to which Licensee obtains or retains Commercialization Rights, whether exclusive or co-exclusive, in one or more Major Market Countries, or Licensee or any of its Affiliates has filed or will file an IND in its own name.

Industrial SCA Product means any composition or formulation consisting of, containing or comprising one or more Single Chain Antibodies intended for any use other than for research or the diagnosis, prophylaxis, or treatment of disease or conditions in humans and other animals.

Licensor Pipeline Product means any Licensed Product as to which Licensor obtains or retains Commercialization Rights, whether exclusive or co-exclusive, in one or more Major Market Countries, or Licensor or its Affiliates has filed or will file an IND in its own name.

Non-Human SCA Product means any composition or formulation consisting of, containing or comprising one or more Single Chain Antibodies under development, approved or used for the diagnosis, prophylaxis or treatment of non-human diseases or conditions, but excluding any BiTE Products.

Research Product means a product consisting of, containing or comprising one or more Single Chain Antibodies used for research purposes and not intended, under development or used for the diagnosis, prophylaxis or treatment of human or non-human diseases or conditions, but excluding any BiTE Research Product.

SCA Product means any composition or formulation consisting of, containing or comprising one or more Single Chain Antibodies that is under development, approved or used for the diagnosis, prophylaxis or treatment of human diseases or conditions, but excluding any BiTE Product.

Field of Use

The field of use is Products for Radioimmunoguided Surgery™ (RIGS®), in which a radiolabelled Single Chain Antibody is administered to a cancer patient; time elapses for preferential concentration of the radiolabelled Single Chain Antibody in neoplastic tissue and decrease of background radioactivity in the patient; and such preferentially concentrated radiolabelled Single Chain Antibody is detected within a surgical operative field by a detector probe placed in juxtaposition with tissue suspected of containing said radiolabelled Single Chain Antibody, and,

Reagents and kits in the research market for production and cloning of genes encoding Single Chain Antibodies and their fusions in a filamentous bacteriophage-derived vector system, and for expression and screening of Single Chain Antibodies fused with the minor coat protein or attachment or adsorption protein of filamentous bacteriophage, and,

Single Chain Antibodies fused with, or for the assay or purification of, Tumor Necrosis Factor alpha (TNF-a) or Lymphotoxin, and, Single Chain Antibodies that bind to OP-1 or related proteins.

License Grant

Licensor hereby grants to Licensee through the period and subject to the limitation on the number of Antigens, the right to receive for each Antigen designated by Licensee, a nonexclusive, worldwide license under the Licensor Licensed Patents to make, have made, use, import, offer to sell and sell Antibodies pursuant to a Licensor License Agreement. This right shall not extend to the Licensor Named Antigens.  The rights of Licensee under the Licensor License Agreements shall include the right to grant sublicenses for Antibodies in accordance with the terms of the applicable Licensor License Agreement.  Each license elected by Licensee hereunder shall be pursuant to a separate Licensor License Agreement and effective as of the date of execution by both parties.

License Property

Antigen means a target molecule, usually a protein, to which an Antibody specifically binds and includes all epitopes on that target molecule.

Antibody means any antibody directed against an Antigen and shall include, without limitation, monospecific and bispecific antibodies (but a separate license shall be required for the antigen involved for each arm of  a  bispecific antibody); less than full-length antibody forms such as Fv, Fab, and F(ab)2; single-chain antibodies; and antibody conjugates bound to a toxin, label or other moiety.  The term 'Antibody' shall include any and all such constructs directed against any particular Antigen.

Licensor Licensed Patents mean the following patents and patent applications known generally as the Cabilly patents and patent applications:

(a) U.S. Patent No. 4,816,567 and the claims relating to chimeric antibodies found in patents or patent applications arising from divisionals, continuations or continuations-in-part of any application from which U.S. Patent No. 4,816,567 claims priority or any substitute applications therefor, any patent issued with respect to any such patent application, any reissue, extension or patent term extension of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent  as well as the foreign counterparts of the foregoing and any and all reissues, reexaminations or extensions of the foregoing (but in any event excluding U.S.S.N. 07/205,419 and foreign counterparts thereof) ('Chimera Patents') and (b)  any patent issuing based on U.S.S.N. 07/205,419 (a continuation of the application maturing into U.S. Patent No. 4,816,567) relating to the coexpression of immunoglobulin chains in recombinant host cells, as well as the divisionals, continuations or continuations-in-part of such U.S.S.N. 07/205,419.

4,816,567 – Recombinant immunoglobin preparations

Field of Use

This agreement pertains to the drug industry.

License Grant

The German Licensor grants to a non-exclusive, worldwide, license under the Licensors Licensed Patents to Exploit Licensed Products other than BiTE Products.

License Property

Licensed Product means any SCA Product, Non-Human SCA Product, Research Product, Industrial SCA Product, BiTE Product, or BiTE Research Product, the composition, manufacture, use of which is claimed by one or more Valid Claims of the Consolidated Patent Portfolio.

BiTE Product means any composition or formulation consisting of, containing or comprising a bi-specific Single Chain Antibody expressed as a single polypeptide chain, binding to T-cells for the diagnosis, prophylaxis or treatment of human or non-human diseases or conditions, but excluding any BiTE Research Product.

Diagnostic SCA (Single Chain Antibodies) Product means an SCA Product that is under development, approved or used for the diagnosis of human diseases or conditions.

Licensee Pipeline Product means any Licensed Product, other than a BiTE Product or BiTE Research Product, as to which Licensee obtains or retains Commercialization Rights, whether exclusive or co-exclusive, in one or more Major Market Countries, or Licensee or any of its Affiliates has filed or will file an IND in its own name.

Industrial SCA Product means any composition or formulation consisting of, containing or comprising one or more Single Chain Antibodies intended for any use other than for research or the diagnosis, prophylaxis, or treatment of disease or conditions in humans and other animals.

Licensor Pipeline Product means any Licensed Product as to which Licensor obtains or retains Commercialization Rights, whether exclusive or co-exclusive, in one or more Major Market Countries, or Licensor or its Affiliates has filed or will file an IND in its own name.

Non-Human SCA Product means any composition or formulation consisting of, containing or comprising one or more Single Chain Antibodies under development, approved or used for the diagnosis, prophylaxis or treatment of non-human diseases or conditions, but excluding any BiTE Products.

Research Product means a product consisting of, containing or comprising one or more Single Chain Antibodies used for research purposes and not intended, under development or used for the diagnosis, prophylaxis or treatment of human or non-human diseases or conditions, but excluding any BiTE Research Product.

SCA Product means any composition or formulation consisting of, containing or comprising one or more Single Chain Antibodies that is under development, approved or used for the diagnosis, prophylaxis or treatment of human diseases or conditions, but excluding any BiTE Product.

Field of Use

The field of use is Products for Radioimmunoguided Surgery™ (RIGS®), in which a radiolabelled Single Chain Antibody is administered to a cancer patient; time elapses for preferential concentration of the radiolabelled Single Chain Antibody in neoplastic tissue and decrease of background radioactivity in the patient; and such preferentially concentrated radiolabelled Single Chain Antibody is detected within a surgical operative field by a detector probe placed in juxtaposition with tissue suspected of containing said radiolabelled Single Chain Antibody, and,

Reagents and kits in the research market for production and cloning of genes encoding Single Chain Antibodies and their fusions in a filamentous bacteriophage-derived vector system, and for expression and screening of Single Chain Antibodies fused with the minor coat protein or attachment or adsorption protein of filamentous bacteriophage, and,

Single Chain Antibodies fused with, or for the assay or purification of, Tumor Necrosis Factor alpha (TNF-a) or Lymphotoxin, and,

Single Chain Antibodies that bind to OP-1 or related proteins.