Royalty Report: Drugs, Antibody, Diagnostic – Collection: 227269

License Grant

With this agreement, the Licensee allows the Licensor access to its antibody library.

Pursuant to this Antibody Library License agreement, the Japanese Licensor will prepare and deliver to the Licensee of England a Development Plan for the relevant Development Antibody in the Territory and Licensor will thereafter use reasonable commercial efforts to
– meet the Milestones set out in such Development Plan and to develop and commercialise Diagnostic Antibody Products and/or Therapeutic Antibody Products as the case may be derived from such Development Antibody; and,
– develop such Diagnostic Antibody Products and/ or Therapeutic Antibody Products in a Major Market and to bring those Diagnostic Antibody Products and/or Therapeutic Antibody Products to market in at least one clinical indication in a Major Market within the time frames set out in the Development Plan; and,
– satisfy market demand for such Diagnostic Antibody Products and/or Therapeutic Antibody Products.

If the Parties, or their Affiliates, enter into a Licensee Antibody Product License Agreement comprising terms typically found in agreements of like nature for similar products, to be negotiated in good faith Licensee shall be granted, to the extent Licensor is able, an exclusive, sub-licensable, license under the Licensor IP to enable it to research, develop and commercialize such Licensee Antibody Products in respect of the relevant Target in any country outside Japan.

License Property

Licensor IP shall mean any Patent Rights, Materials or Know How relating to a Target, Diagnostic Antibody Products, Therapeutic Antibody Products and Other Products which are owned by, or licensed to Licensor, at the Commencement Date or which become owned by or licensed to Licensor ( other than Licensee IP) during the term of this Agreement and any Patent Rights, Materials or Know How owned by or licensed to Licensor ( other than Licensee IP) which relate to a Licensee Library Antibody which has been assigned to Licensor.

Licensor Nominated Targets shall mean the Targets nominated by Licensor and accepted by Licensee for inclusion in the Nominated Target List after the Commencement Date.

Product License shall mean an exclusive, worldwide, sublicensable, royalty bearing license under the Licensee IP to develop, make, have made, use, import, market and sell Development Antibodies, Diagnostic Antibody Products and Therapeutic Antibody Products in the Territory.

Product shall mean a Diagnostic Antibody Product or a Therapeutic Antibody Product.

Field of Use

Licensee is a leader in the field of rapid human antibody discovery, engineering and other related activities in the use of antibodies for target validation, drug design, and the development of proprietary therapeutic and diagnostic products.

This license to be granted to Licensee by Licensor shall only be in respect of the relevant Licensee Antibody Product and shall only be to the extent needed by Licensee to research, develop and commercialize that Licensee Antibody Product in respect of the relevant Target.

License Grant

With this amendment, in the event Licensor of the United Kingdom notifies Licensee that a Product License can be granted to Licensee with respect to Products against a Nominated Target, then upon receipt by Licensor of the applicable Acceptance Fee, Licensor agrees to grant and hereby grants to Licensee and its Affiliates a non-exclusive, royalty-bearing license, with the right to sublicense, under the Antibody Phage Display Patents and Licensor Know-How to Exploit Products against such Nominated Target in the Territory.

License Property

The Antibody Phage Display Patents include Single Domain Ligands, Receptors Comprising said Ligands, Methods for their Production and Use of Said Ligands and Receptors, and, Co-expression of Heteromeric Receptors, and, Method for Isolating Receptors Having a Preselected Specificity, and, A new method for tapping the immunological repertoire, and, Methods for producing members of specific binding pairs, and, Treatment of Cell Populations, and, Production of chimeric antibodies – a combinational approach, and, Production of anti-self antibodies from antibody segment repertoires and displayed on phage, and, Methods for producing members of specific binding pairs, and, SBP members with a chemical moiety covalently bound within the binding site; production and selection thereof, and, Recombinant Binding Proteins and peptides,and, Labelling and selection of Specified Binding Molecules.

The Licensor Know-how includes Licensor Training Manual Antibody Phage Display 2002, and, Licensor mammalian expression IgG vectors
pEUl.2 (human gamma-I heavy chain)
pEU3.2 (human kappa light chain)
pEU4.2 (human lambda light chain)
pEU8.2 (human gamma-4 heavy chain)

Field of Use

The agreement is for nominated target(s) which is(are) potentially useful for the development of any Diagnostic Antibody Product and/or any Therapeutic Antibody Product.

Diagnostic Antibody Product means any preparation in the form of a device, compound, kit or service with utility in the diagnosis, prognosis, prediction or disease management of a disorder for any indication outside the Excluded Field which contains, comprises or the process of development or manufacture of which utilizes a Licensor Licensable Antibody.  The term Diagnostic Antibody Product shall not include any Research Product.

Therapeutic Antibody Product means any preparation for the treatment or prevention of disease, infection or other condition in humans for any indication outside the Excluded Field which contains, comprises, or the process of development or manufacture of which utilizes, a Licensor Licensable Antibody. The term Therapeutic Antibody Product shall not include any Research Product.

Excluded Field means the discovery, isolation, characterization, research, development, and/or 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 or neuroprotection
(a) neurodegenerative conditions, including but not limited to (i) Alzheimers disease, and (ii) Parkinsons disease, but in both instances, excluding the  treatment and/or prevention of neurodegenerative conditions in humans associated with P-amyloid deposition (including, without limitation, Alzheimers disease and/or Mild Cognitive Impairment, using either (A) immunological approaches directed at one or more epitopes of AP or any naturally occurring variants thereof, including, without limitation, the administration of an Antibody, or (B) use of a beta secretase inhibitor, including, without limitation, the administration of an Antibody);
(b) diabetic neuropathy;
(c) pain, including, but not limited to, (i) post-operative pain, (ii) chronic pain and (iii) neuropathic pain,
(d) spinal cord injury;
(e) multiple sclerosis; and/or
(f) stroke, as a disease of the cerebrovasculature.

The term Excluded Field shall not include the diagnosis, treatment and/or prevention of the above disease conditions caused by infectious pathogenic micro-organisms.

License Grant

Research License hereby grants Licensee a non-exclusive, worldwide, non-transferable, royalty-free license for internal use under the Licensor Patents, Licensor Know-How and Licensors interest in the Joint Patents to the extent necessary (i) to permit Licensee to conduct its obligations and (ii) to use and characterize Targets, including, without limitation, the Overlap Targets. The license set forth above includes the right to sublicense.

Pre-Opt-In Products and Licensee Products. Subject to the terms of this Agreement, Licensor hereby grants Licensee a worldwide, exclusive license, including the right to sublicense, under the Licensor Patents, Licensor Know-How and Licensors interest in the Joint Patents (i) to use the Targets (other than Overlap Targets) for the purpose of creating, developing and marketing antibodies for commercial purposes, (ii) to use Antibody Target Candidates and Antibody Targets to make, have made, use, develop and test Antibodies, and (iii) to make, have made, use, develop, test, sell, offer to sell, have sold and import Pre-Opt-In Products and Licensee Products. Such license shall include all human prophylactic and therapeutic indications for Pre-Opt-In Products and Licensee Products and shall be milestone and royalty-bearing as set forth. The exclusivity of the license set forth is subject to Licensors retained rights.

Co-Funded Products  Licensor hereby grants Licensee a worldwide, co- exclusive license (with Licensor), including the right to sublicense, under the Licensor Patents, Licensor Know-How and Licensors interest in the Joint Patents to make, have made, use, develop, test, sell, offer to sell, have sold and import Co-Funded Products. Such license shall include all human prophylactic and therapeutic indications and shall involve profit-sharing with respect to any such Product in lieu of royalties and milestones.

Licensee Diagnostic Products  Licensor hereby grants Licensee a worldwide, co-exclusive license, including the right to sublicense, under the Licensor Patents, Licensor Know-How and Licensors interest in the Joint Patents to make, have made, use, develop, test, sell, offer to sell, have sold and import Licensee Diagnostic Products. At the time Licensee identifies a Third Party manufacturer for any such Licensee Diagnostic Product, Licensee may request the co-exclusive license be converted to an exclusive license. Licensor agrees to grant Licensee an exclusive license unless_a diagnostic product for the same Antibody Target has been submitted to the FDA for marketing approval. Such license shall include all human diagnostic indications and shall be, with respect to Licensee Diagnostic Products developed for use with Licensee Products, milestone and royalty-bearing as set forth and shall involve profit-sharing, with respect to Licensee Diagnostic Products developed for use with Co-Funded Products, in lieu of royalties as set forth.   Any exclusive license granted shall be subject to a retained right by Licensor and its licensees to make, have made, use, have used, develop, have developed and test Licensee Diagnostic Products for (i) internal research purposes or (ii) drug discovery, clinical development, pharmacogenomics analysis and inclusion in the labeling of non-antibody therapeutics and prophylactics against the same Antibody Target.

Antibody Inventions  Licensor hereby grants Licensee a worldwide, exclusive license, including the right to sublicense, under the Antibody Patents that claim Antibody Inventions invented solely or jointly by Licensee to practice such Antibody Inventions for all purposes.

License Property

Product means any therapeutic or prophylactic product developed under this Agreement, for any indication, incorporating all or substantially all of at least one variable region of an Antibody.

Licensee Diagnostic Product means a product that is being or has been developed for detection of an Antibody Target for use with a Licensee Product or a Co-Funded Product.

Antibody Inventions means an Invention directed to Antibodies, including without limitation, composition of matter, methods of manufacture, methods of use, formulations, dosing regimens, etc.

Pre-Opt-In Product means a Product for which Licensor has not made a decision whether to co-fund and for which the Opt-In Period has not expired.

Target(s) means [a gene or gene product from the Target Pool]. The term Target(s)' shall include Antibody T~get Candidates and Antibody Targets, but shall exclude specified Targets if and when such Targets cease to be Targets.

Target Pool means all human orthologues whenever identified, of the Model System Targets.

Field of Use

This agreement pertains to the drug industry to utilize the technology and expertise to identify and characterize targets for the treatment of cancer and precancerous conditions, controlling cell growth, apoptosis, and proliferation, to generate antibodies directed against such targets, and to develop and commercialize novel antibody products for diagnostic, prophylactic and therapeutic uses.

License Grant

With this agreement, Licensee wishes Licensor to apply its technology and know-how to genetically engineer a Single-Chain Antibody.

The Licensor of Scotland agrees to grant the German Licensee under the patent rights a non-exclusive world-wide licence to the extent necessary to commercialise the Deimmunised antibody and/or the deliverables in the field.

Licensor grants for each specific Deimmunised antibody a non-exclusive licence under the patent rights to the extent necessary for worldwide commercialisation of the Deimmunised antibody derived from the specific Single-Chain Antibody sequence.

License Property

Licensor has certain proprietary technology, materials and know-how in genetic engineering of biological materials, including single-chain antibodies, relating to removal of potentially immunogenic sequences, from the variable regions of antibodies, or Delmmunisation to produce an antibody for therapeutic and/or in vivo diagnostic purposes.

Licensee is the owner of a cDNA which encodes a Single-Chain Antibody which binds to a specific antigen.

Licensor patent rights shall mean all patent applications and granted patents relevant to Deimmunization Technology.

Deimmunised antibody shall mean all genetically engineered variant(s) of the single-chain antibody  arising from the research.

Deimmunization technology shall mean the technical process applied by Licensor to generate Deimmunised antibody as outlined in the research program.

DeImmunisation increases the clinical potential of antibody and protein therapeutics by eliminating/reducing the T-cell response caused when the therapeutic molecule is recognised as foreign by the patient's immune system. The technology is based on ‘peptide threading' and works by identifying potential T-cell epitopes on the therapeutic antibody or protein. T-cell epitopes are sites on the therapeutic molecule which can bind to MHC class II, triggering a T-cell mediated immune response. Once this potentially immunogenic region of the antibody is identified, it is removed from the molecule by single amino acid substitutions, thus eliminating/reducing the therapeutic antibody or protein's immunogenicity and increasing its safety. This can be done without compromise to efficacy.

Field of Use

The field shall mean the field of human therapy and human in vivo and in vitro diagnostics limited to the Single-Chain Antibody.

License Grant

Licensor of the United Kingdom grants the following options to obtain Product Licenses which may be exercised by Licensee for itself and for Licensee Sublicensees
(a) an Initial License Allocation of up to (31) Product Licenses for Therapeutic Antibody Products and/or Diagnostic Antibody Products shall be available from the Commencement Date;
(b) an Additional License Allocation of up to (75) Product Licenses for Therapeutic Antibody Products and Diagnostic Antibody Products shall be available from the Commencement Date;
(c)  (35) Diagnostic Collaboration Licenses for Diagnostic Antibody Products shall be available from the Commencement Date; and
(d) (30) Additional Diagnostic Licenses for Diagnostic Antibody Products shall be available
from the Commencement Date.

Licensor grants the option for Licensee to obtain the (20) Product Licenses for both Therapeutic Antibody Products and Diagnostic Antibody Products, which may be exercised by Licensee only on a cumulative basis in accordance with the following schedule
(a) seven (7) Product Licenses on or before 31 December 2003;
(b) four (4) additional Product Licenses on or before 31 December 2004;
(c) three (3) additional Product Licenses on or before 31 December 2005;
(d) six ( 6) additional Product Licenses on or before 31 December 2006.

In addition to the options for Product Licenses granted, Licensor grants the option for a total of an additional seventy five (75) Product Licenses for both Diagnostic Antibody Products and Therapeutic Antibody Products to be granted to Licensee; provided that if any option for a Product License has not been exercised and granted to Licensee on or before 31 December 2017, then the option for such Product License will lapse irrevocably.

In addition to the options for Product Licenses granted, Licensor grants to the option for a total of an additional thirty-five (35) Product Licenses for Diagnostic Antibody Products developed by Licensee under the Specified Diagnostic Agreements (the Diagnostic Collaboration Licenses); provided that if any option for a Diagnostic Collaboration License has not been exercised by Licensee on or before 31 December 2017, then the option for such Product License will lapse irrevocably.

In addition to the options for Product Licenses granted, Licensor grants to the option for a total of an additional thirty (30), Product Licenses for Diagnostic Antibody Products (the Additional Diagnostic Licenses); provided that if any option for an Additional Diagnostic Licenses has not been exercised by Licensee on or before 31 December 2017, then the option for such Product Licenses will lapse irrevocably.

Prior to the commencement of human trials for a Product, and provided that Licensee obtains a Product License for such Product prior to commencing human trials for such Product, Licensor grants, a non-exclusive, royalty free license in the Territory during the term of this Agreement to use the Licensor Antibody Phage Display Patents and Know-How for the purposes of carrying out research and development activities in relation to identifying Licensor Licensable Antibodies or potential Products.

For the Grant of Product License by Licensor,  Licensor agrees grants a non-exclusive, license, with the right to sublicense, under the Licensor Antibody Phage Display Patents and Licensor Know-How to Exploit Products against such Nominated Target in the Territory.

For the Grant of Other Licenses, Licensor grants with effect from 3 January 2003 to Licensee a non-exclusive license in the Territory, with the right to sublicense, under the Licensor Antibody Phage Display Patents and Know-How for any purpose not already covered by the provisions of this Agreement (Other Purposes) including to Exploit any product, other than a Therapeutic Antibody Product, Diagnostic Antibody Product
or Research Product, whose development, manufacture, use or sale would, absent the license hereunder, infringe Valid Claims of the Licensor Antibody Phage Display Patents or utilize the Licensor Know-How (Other Product).

This agreement includes an exclusive option grant from Licensee to Licensor.

License Property

Licensor is the owner of certain Antibody Phage Display patents and know-how.

Product means a Diagnostic Antibody Product or a Therapeutic Antibody Product.

Licensed Product means any product intended for sale to an End User as a human or non-human therapeutic or in vitro diagnostic or research reagent ( and in the case of a diagnostic or research reagent contains one or more antibodies as a binding moiety) that prior to or after December 31, 1997 (the effective date of the Original Agreements) is discovered, made or developed, whether by Licensor, its Affiliates or any Commercial Party, using a Licensed Intermediate or a method covered in whole or in part by the Licensee Patent Rights.

Field of Use

The Field of Use means research and development and human or non-human therapeutics and human or nonhuman in vitro diagnostic or research reagent uses only and not any in vivo diagnostics, purifications or separations, or other industrial purposes.

License Grant

Subject to Third Party rights the United Kingdom Licensor, government organization, grants to the United Kingdom Licensee during the continuance of this Agreement the following rights and licenses under the Patent Rights and the Technology on the following conditions
For the Exclusive Rights
Licensor grants the exclusive right and license under Licensee License Conditions to identify, develop, make, have made, import, market and sell selective antibodies for human in vivo use and includes using an antibody gene as a therapeutic entity in gene therapy provided always that Licensee will grant up to six exclusive sub-licenses to develop, make, have made, use, import, market and sell a specific antibody product directed at a particular antigen, for the avoidance of doubt it is declared antibodies derived from  SCID Hu mice would count within this total, to the Collaborative Centre, but excluding any right of access or license to use Licensee Libraries, with the right for the Collaborative Centre to sub-sub license for royalties payable by the Collaborative Centre to Licensee and on financial terms.

And, the exclusive right and license under Licensee License Conditions to use antibodies as part of a medical, but not a research, procedure involving in vitro selection of Rare Cell Population for therapy or diagnosis.

And, the exclusive right and license under Licensee License Conditions to provide Antibody Isolation Services for third parties.

And, the exclusive right and license under Licensee License Conditions to use and exploit commercially in any way whatsoever the inventions the subject of the patent and its corresponding patents for Diabodies except in the following fields of use
(a) biosensors;
(b) therapeutic products which include mammalian retroviruses encoding diabodies as a fusion with viral coat proteins; and
(c) diabodies generated from combinations of four specific antibodies.

And, the exclusive right and license under Licensee License Conditions to use molecules isolated by the Technology for use in the manufacturing process of pharmaceutical products or intermediates.

And, the exclusive right and license under Licensee License Conditions to develop, make, have made, use, import, market and sell Catalytic Antibodies or Research Products.

And, for Co-exclusive rights
the co-exclusive right and license for Licensee under Licensee License Conditions to improve. develop, make, have made, import, market and sell antibodies originally isolated by hybridoma derived methods from non-primate sources which have been humanized using CDR grafting techniques the subject of the patent known as Winter l, derived from the UK Patent application UK 860 7679 filed 27 March 1986-and US Parent Application 903776.

And, the co-exclusive right and license for Licensee under Licensee License Conditions to use antibody structural information to design non-antibody drug candidates.

And, for Gene-sequencing and analysis rights,  the exclusive right and license under Licensee License Conditions to use antibody repertoires and libraries and antibodies isolated from them in the identification, analysis and validation of targets for therapeutic, diagnostic or prophylactic entities arising from gene sequencing data and analysis provided always that Licensor shall have the right, which for the avoidance of doubt it is declared and agreed does not include any right of access to or license to use the Licensee Libraries, to grant collaborative licenses.

And, for the Third Party License, a non-exclusive license to third party companies who are licensed by Licensor to use and exploit other Licensor pending or granted patent rights or technology which third
parties focus and which other Licensor rights are not principally in the field of therapeutic antibodies.

And, for the non-exclusive rights,  the non exclusive right and license under Licensee License Conditions for all purposes other than those specifically excluded.

This Party agreement is, in relation to such a target, an exclusive license to develop, make, have made, market and sell only therapeutic antibodies to any such target; and, in relation to such a Product which is an actual or potential therapeutic antibody an exclusive license to develop, make, have made, market and sell only such therapeutic antibody.

License Property

Products means any product or formulation whose development, manufacture, use or sale would, absent a license, infringe the Patent Rights or utilize the Technology.

Catalytic Antibodies means antibodies which bind to and catalyze the chemical transformation of a substrate and in which an antibody binding region is involved in said catalysis.

Patents include Cloning Immunoglobulin Variable Domain Sequences; Methods for producing members of specific binding pairs; Production of chimaeric antibodies, a combinational approach; Production of anti-self antibodies from antibody segment repertoires and displayed on phage; Methods for producing members of specific binding pairs; SBP members with a chemical moiety covalently bound within the binding site production and selection thereof; Recombinant Binding Proteins and Peptides; and, Treatment of cell populations.

Field of Use

The use of the antibodies is intended for medical procedure, not research.  

The third party rights are for the field of human drug therapy by antibodies directed against the CD4-binding domain of the HIV-1 gp 120 protein.

License Grant

Licensor grants a Sublicense to Licensee and its Affiliates, to use the Licensor Antibodies, Cell Lines and Derivatives for the purpose of making, having made, using, selling and having sold Licensee Products.  Licensor shall provide Licensee quantities of Licensor Antibodies or Cell Lines and Derivatives, and information relating thereto.  Licensor agrees to deliver additional viable aliquots of Cell Lines or Derivatives to replace any aliquots previously delivered, which have subsequently become incapable of producing Licensor Monoclonal Antibodies and which are the same as the Licensor Cell Lines or Derivatives previously received by Licensee.

In order to protect Licensees source of supply of the Cell Lines or Derivatives Licensor warrants and agrees that Licensor shall maintain the Cell Lines and Derivatives in such a manner as will best preserve the viability thereof, in accordance with established scientific procedures.

License Property

Licensor holds exclusive licenses with respect to the Antibodies. Licensor is a supplier of specialty reagents, immuno-assay test kits and molecular research products to customers involved in biomedical research, the biotechnology industry and pharmaceutical drug discovery.

Monoclonal Antibodies to Human Interferongamma
        *1.       Antibody B133.5

         2.       Antibody 3C11C8

         3.       Antibody 2G1

Monoclonal Antibodies to Human Granulocyte Marophage-Colony Stimulating Factor

         1.       Antibody 3092

         2.       Antibody 3034

         3.       Antibody 1089

         4.       Antibody 4117

         5.       Antibody 2118

         6.       Antibody 1028

Monoclonal Antibodies to Human Tumor Necrosis Factor-alpha

         *1.      Antibody B154.7.1

         *2.      Antibody B154.9.1

Field of Use

The purpose for this agreement is for research use.