Royalty Report: Drugs, Disease, Therapeutic – Collection: 291138

License Grant

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

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

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

License Property

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

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

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

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

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

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

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

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

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

Field of Use

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

License Grant

Licensor, government organization, hereby grants and Licensee of the Netherlands accepts an exclusive license and non-exclusive license, as specified, under the Licensed Patent Rights in the Licensed Territory to make and have made, to use and have used, to sell and have sold, to offer to sell, and to import any Licensed Products in the Licensed Fields of Use and to practice and have practiced any Licensed Processes in the Licensed Fields of Use.

License Property

Licensed Patent Rights shall mean:
(a) Patent applications (including provisional patent applications and PCT patent applications) or patents listed, all divisions and continuations of these applications, all patents issuing from these applications, divisions, and continuations, and any reissues, reexaminations, and extensions of these patents;
(b) to the extent that the following contain one or more claims directed to the invention or inventions disclosed in 2.8(a):
    (i)     continuations-in-part of 2.8(a);
    (ii)    all divisions and continuations of these continuations-in-part;
    (iii)   all patents issuing from these continuations-in-part, divisions, and continuations;
    (iv)   priority patent application(s) of 2.8(a); and
    (v)    any reissues, reexaminations, and extensions of these patents;
    (c)    to the extent that the following contain one or more claims directed to the invention or inventions disclosed in 2.8(a): all counterpart foreign and U.S. patent applications and patents to 2.8(a) and 2.8(b), including those listed; and
    (d)    Licensed Patent Rights shall not include 2.8(b) or 2.8(c) to the extent that they contain one or more claims directed to new matter which is not the subject matter disclosed in 2.8(a).

Patent(s) or Patent Application(s):
1. U. S. Patent 6,984,517, issued January 10, 2006, entitled “AAV5 Vector and Uses Thereof; U.S. Patent 7,479,554, issued January 20, 2009, entitled “AA V5 Nucleic Acids”as well as all issued and pending foreign counterparts [HHS Ref. No. E-127-1998/0];

2. U. S. Patent 6,855,314, issued February 15, 2005, entitled “AAV5 Vector for Transducing Brain Cells and Lung Cells” [HHS Ref. No. E-072-2000/0].

Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

Adeno-associated virus (AAV) is a small virus which infects humans and some other primate species.

Field of Use

This agreement pertains to the drug industry.

Exclusive Licensed Field of Use: (i) Use of the Licensed Patent Rights for the development and sale of AAV5 based therapeutic products to be delivered to the brain or liver for treatment of human diseases originating in the brain or liver; (ii) Note that arthritis related diseases are expressly excluded.

Non-Exclusive Licensed Field of Use: Use of the Licensed Patent Rights for the development and sale of AAV5 based therapeutic products to treat human diseases other than the ones covered under (a)(i).

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

The Parties have an acquisition agreement.  Upon consummation of the Acquisition, the Parties desire to establish a new cooperative development program intended to discover, develop, and certify for use in humans one or more new pharmaceutical products.

Licensor grants an exclusive, worldwide license under the Ad Interferon-beta Product Licensor Patents and the Ad Interferon-beta Product Technology to develop, research, make, have made, use, have used, sell, offer for sale, import and have sold the Ad Interferon-beta Product in the Cancer Field and the Beta Interferon Field .

For the Manufacturing License,  Licensor will provide a transferable, limited license or subiicense as the case may be under the Licensor Technology and the Licensor Patents to manufacture such Clinical Vectors and Commercial Vectors to the extent necessary to enable Licensee to manufacture quantities of the Clinical Vectors and Commercial Vectors that otherwise would have been supplied by Licensor to Licensee under this Agreement, solely for use and application by Licensee for the uses and applications in the Territory that would be permitted under this Agreement with respect to such Clinical Vectors and Commercial Vectors purchased from Licensor.

Licensor grants a license, with right to grant sublicenses, under the Licensor Technology and the Licensor Patents to research, develop, manufacture, have manufactured, use, import, export, offer to sell or sell Products in the Territory.

Licensor grants  a nonexclusive, worldwide license, with right to sublicense to Contractors permitted under this Agreement,  to the Licensed Technology, other than the Applied Licensor Technology, as designated in the applicable Project Plan and Budget, and under any Licensor Patents, other than the Exhausted Licensed Patents and the Exempted Licensed Patents, as designated in the applicable Project Plan and Budget, which would, but for this license grant, be infringed by Licensees performance of its Development Tasks solely as necessary for performance of Licensees Development Tasks during and in the course of any approved Development Project.

In addition to the other rights granted under this Agreement, Licensor hereby grants an option to acquire a license, with the right to grant sublicenses, to Licensor Technology, that is not otherwise designated as Applied Licensor Technology in the applicable Project Plan and Budget, and under any and all Targeted Patents, that are not designated as Exhausted Licensor Patents or as Exempted Licensor Patents in the applicable Project Plan and Budget.

License Property

The patents include Adenovirus Vectors for Gene Therapy, and, .Method of Reducing an Immune Response to a Recombinant Adenovirus.

AAV Interferon-beta Product means a Product incorporating the Beta Interferon Gene and any AAV Vector as the delivery platform.

AAV Vector means an adeno-associated viral vector useful or potentially useful for the delivery of Genes to human cells.

Ad Interferon-beta Product means the Product incorporating the Beta Interferon Gene and an Ad Vector that is the subject of the Ad Interferon-beta Project.

Ad Vector means an adenoviral vector useful or potentially useful for the delivery of Genes to human cells.

Field of Use

Beta Interferon Field means the treatment or prevention in humans of one or more diseases through the use or application of one or more gene therapy vectors to deliver Genes; such Genes being defined herein as the Beta Interferon Genes.

Cancer Field means the treatment or prevention in humans of one or more cancers through the use or application of AAV Vectors or Ad Vectors.

License Grant

Buyer grants to Seller a non-exclusive, perpetual, irrevocable, worldwide license under the Transferred Manufacturing Technology, Seller Manufacturing Patent Rights, Johnson Patent Rights, Transferred Platform Technology, Seller Platform Patent Rights and Exclusively Licensed Materials to develop, make, have made, use, sell offer for sale and import AAV Vectors, and products containing AAV Vectors, solely within the field.

In the asset purchase, the Seller agrees to sell, convey, transfer and assign to Buyer, and Buyer agrees to purchase from Seller, free and clear of any Encumbrances, all of Seller’s right, title and interest in and to the following properties, assets and rights:
(a) the Transferred Technology;
(b) the Assigned Patent Rights;
(c) the Transferred Equipment;
(d) all of Seller’s rights under that certain Exclusive Sublicense Agreement; and
(e) all rights of Seller to Actions and rights of Seller to sue at law or in equity.

License Property

AAV Vector shall mean a recombinant adeno-associated virus gene vector composed of a viral capsid and a genome.

Excluded Technology shall mean (i) any composition that is specific to a particular AAV Vector serotype or pseudotype and any data and other Technology that is specific to such a composition; any composition, method, process or other Technology that is specific to an AAV Vector comprising a particular gene; any composition, method, process or other Technology that is specific to a particular gene; any final formulation buffer for clinical delivery of an AAV Vector comprising a particular gene and any data or other Technology that is specific to such buffer; and any analytical method specific to product performance of an AAV Vector comprising a particular gene.

Field of Use

This agreement is for solely within the following four fields:
(iii) delivery of tgAAC94 as identified in Seller's regulatory filings as of the Closing Date which comprises the DNA sequence encoding the p75 TNFr receptor lg fusion protein, and
(iv) the delivery of RNAi using AA V Vectors for the revention or treatment of Hepatitis C.

License Grant

University grants to Licensee a license under Universitys interest in Patent Rights to make, use, sell, offer for sale, and import Licensed Products and to practice Licensed Methods in the Field, within the Territory and during the Term.  The amendment adds the patent information.

The licenses granted in this paragraph is exclusive with respect to the Field only.

License Property

The patent is for the therapy treatment or prevention of cardiovascular disease.

Licensed Product means any composition or product that is covered by the claims of Patent Rights, or that is produced by a-Licensed Method, or the manufacture, use, sale, offer for sale, or importation of which would constitute, but for the license granted to Licensee under this Agreement, an infringement of any pending or issued and unexpired claim within the Patent Rights.

Field of Use

The Field means gene therapy for the treatment or prevention of cardiovascular diseases by the delivery of a gene or a synthetic equivalent (DNA, deoxyribonucleic acid or polydeoxyribonucleotide sequence), in whole or in part or in combination, including those encoding one or more phospholamban genes and/or SERCA-2 (sacroplasmic reticulum calcium ATPase) genes, or their mutants, excepting the involvement of anti-sense RNA (ribonucleic acid or polyribonucleotide sequence) of the phospholamban gene.

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

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

License Property

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

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

Field of Use

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

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

License Grant

Licensor grants to the Licensee of the Netherlands a non-exclusive, non-sublicensable license under the Licensed Patent Rights in each country of the world where there are Valid Claims of Licensed Patent Rights, to make, have made, develop, use, sell, offer to sell and import Licensed Products.

License Property

Licensor has patent rights related to an AAVl Vector gene delivery system.  AAV1 Vector means the adeno-associated virus serotype 1 vector technology which includes without limitation the AAV serotype 1 rep, cap, and ITR sequences and proteins whether utilized in whole or in part to deliver therapeutic genes into cells.

Field of Use

Field means treatment of Lipoprotein Lipase, or LPL, deficiency type 1 and LPL deficiency type 5 by in vivo gene therapy utilizing an AAV 1 Vector encoding the LPL gene.

AMT intends to use the vector for developing therapeutics for treating type I and type V lipoprotein lipase (LPL) deficiency. In particular, AMT will use the vector in the development of its lead gene product, AMT-011, which is in Phase II clinical trials.

Lipoprotein lipase deficiency is a genetic disorder in which a person has a defective gene for lipoprotein lipase, which leads to very high triglycerides, which in turn causes stomach pain and deposits of fat under the skin, and which can lead to problems with the pancreas and liver, which in turn can lead to diabetes.

License Grant

Licensor hereby grants and Licensee accepts, subject to the terms and conditions of this Agreement, an exclusive license under the licensed patent rights in the licensed territory to make and have made, to use and have used, to sell and have sold, to offer to sell, and to import any licensed products in the licensed fields of use and to practice and have practiced any licensed processes in the licensed fields of use.

License Property

Licensed Products(s) means tangible materials which, in the course of manufacture, use, offer to sell, sale, or importation would, in the absence of this agreement, infringe one or more claims of the licensed patent rights that have not been held invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

Licensed patent rights shall mean:  Patent applications (including provisional patent applications and PCT patent applications) and/or patents listed below, all divisions and continuations of these applications, all patents issuing from such applications, divisions, and continuations, and any reissues, reexaminations, and extensions of all such patents.

U.S. Patents: 5,840,686 issued 24 November 1998 from USSN 08/257,953 filed 7 June 1994 and entitled Pigment epithelium-derived factor: characterization of its novel biological activity and sequences encoding and expressing the protein and methods of use

U.S. Patent Applications: 08/367,841, 08/520,373,  07/894,251

Licensed process(es) means processes which, in the course of being practiced would, in the absence of this agreement, infringe one or more claims of the Licensed Patent Rights that have not been held invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

Field of Use

Licensed fields of use means Gene Therapy for Ocular Disease, including but not limited to, mascular degeneration, cancer, diabetic retinopathy, ocular histoplasmosis syndrome, and retinopathy associated with neovascularization in neonatals.

License Grant

Licensor grants a non-exclusive, worldwide license, including the right to grant sublicenses through multiple tiers of sublicense, under the Patent Rights solely to develop, make, have made, use, offer for sale, sell, have sold, import, have imported, export and have exported Products in the Field of Use.

License Property

The patent relates to genetically-engineered parvovirus capsids and viruses designed to introduce a heterologous gene into a target cell.

Field of Use

The Field of Use shall mean the production and delivery of adeno-associate viral vector (AAV) Serotype 1 to deliver SERCA 2a for the treatment of heart failure and arrhythmias.

License Grant

Licensor, government organization, hereby grants and Licensee of the Netherlands accepts a nonexclusive license under the Licensed Patent Rights in the Licensed Territory to make and have made, to use and have used, to sell and have sold, to offer to sell, and to import any Licensed Products or New Products in the Licensed Fields of Use, to practice and have practiced any Licensed Processes in the Licensed Fields of Use, to make, have made, to use and have used but not to sell any Supplied Materials.  As used in this Agreement, “have made” and “have used” means that Licensee shall have the limited right to use a third party contract manufacturer to make and use only (but not to sell) Supplied Materials, Licensed Products or New Products.  Licensee acknowledges and agrees that any such third party contract manufacturer shall be bound to the terms and obligations of this Agreement.

License Property

Licensed Patent Rights shall mean:
(a)  Patent applications (including provisional patent applications and PCT patent applications) or patents listed, all divisions and continuations of these applications, all patents issuing from these applications, divisions, and continuations, and any reissues, reexaminations, and extensions of all these patents;
(b)  to the extent that the following contain one or more claims directed to the invention or inventions disclosed in 2.6(a):
     (i)    continuations-in-part of 2.6(a);
     (ii)   all divisions and continuations of these continuations-in-part;
     (iii)  all patents issuing from these continuations-in-part, divisions, and continuations;
     (iv)  priority patent application(s) of 2.6(a); and
     (v)   any reissues, reexaminations, and extensions of all these patents;
(c) to the extent that the following contain one or more claims directed to the invention or inventions disclosed in 2.6(a): all counterpart foreign and U.S. patent applications and patents to 2.6(a) and 2.6(b), including those listed in Appendix A; and
(d) Licensed Patent Rights shall not include 2.6(b) or 2.6(c) to the extent that they contain one or more claims directed to new matter which is not the subject matter disclosed in 2.6(a).

U.S. Patent Application(s) or Patent(s):
(a)  U.S. Patent Application Serial No. 09/986,618, filed November 9, 2001, now abandoned, entitled “Production of Adeno-Associated Virus in Insect Cells” [HHS Ref. No. E-325-2001/0-US-01];
(b)  U.S. Patent No. 6,723,551, issued April 20, 2004, entitled “Production of Adeno-Associated Virus in Insect Cells” [HHS Ref. No. E-325-2001/1-US-01]; and
(c)  U.S. Patent Application Serial No. 10/415,834, filed May 2, 2003, entitled “Production of Adeno-Associated Virus in Insect Cells” [HHS Ref. No. E-325-2001/2-US-02].

Licensed Products means (a) Supplied Materials and (b) tangible materials, which in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

New Product means a product made using a Licensed Process but excluding Licensed Products.

Licensed Processes means processes, which in the course of being practiced, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

The Disease: Lipoprotein Lipase Deficiency
Genetic lipoprotein lipase (LPL) deficiency results in profound hypertriglyceridemia, which is associated with intense chronic abdominal pain, hepatosplenomegaly, eruptive xanthomas, lipemia retinalis, dyspnea, mono- or polyparesthesias, and memory loss. Prolonged elevations in plasma triglycerides (TG) also induce recurrent episodes of often lethal pancreatitis, chronic pancreatic insufficiency, and diabetes mellitus. Currently, no effective treatment for this disease exists. Patients must follow a strict low-fat diet. However, TG levels often remain above the critical threshold. Genetic LPL deficiency type I is a rare, autosomal recessive trait. Prevalence varies between 1 in 1,000,000 in the general population to 1 in 5,000 in French Quebec (a ‘founder effect’).

Acute intermittent porphyria (AlP) is an autosomal dominant inherited condition caused by mutations in the porphobilinogen deaminase (PBGD) gene. The PBGD gene is located on chromosome 11 q24.1 -24.2 and spread over fifteen exons. The protein encoded by this gene is a rate-limiting enzyme, the PBGD enzyme, in the haem synthetic pathway.

Parkinson’s disease (PD) is a progressive neurodegenerative disease, resulting in tremors, stiffness, slowness of movement, and lack of coordination. Patients are faced with a severely debilitating disease and a serious loss in quality of life. PD is caused by degeneration and death of nerve cells in a specific part of the brain known as the substantia nigra. These cells produce dopamine, a substance necessary for communication between nerve cells involved in the coordination of movement.

Field of Use

This agreement pertains to the drug industry relating to the use of the Licensed Patent Rights for the commercial development of AAV related products within the scope of the Agreement.

Licensee is building gene therapies using adeno-associated viral (AAV)-based vectors.

License Grant

The University grants the non-exclusive right and license to make, have made, use, lease and sell the Licensed Products, and to practice the Licensed Processes in the Territory for the Fields of Use to the end of the term for which the Patent Rights are granted unless sooner terminated according to the terms hereof.

License Property

The patent is for AAV Transduction Vectors.

A Licensed Process is any process which is covered in whole or in part by an issued, unexpired claim or a pending claim contained in the Patent Rights; or, Patent Rights; or, is derived from Patent Rights or know-how, and related to or described in is sold, manufactured or used in any country under this Agreement.

A Licensed Product shall mean any product or part thereof which is covered in whole or in part by an issued, unexpired claim or a pending claim contained in the Patent Rights in the country in which any Licensed Products are made, used or sold; or,  is manufactured by using a process which is covered in whole or in part by an issued, unexpired claim or a pending claim contained in the Patent Rights in the country in which any Licensed Process is used or in which such product or part thereof is used or sold; or,
is derived from Patent Rights or know-how, and related to or described in Patent Rights.

Field of Use

The Fields of Use shall mean:
(a) Human [blood] disorders, [metabolic and congenital]. This field includes human [hematological] diseases that arise due to the absence, over-expression or altered expression of proteins normally (present in blood]. The primary site and location of these proteins is [blood]. Specifically included are human [hemoglobinopathies (i. e. Sickle Cell Anemia and Thalassemia)] and human disorders of the [coagulation metabolism (i.e., Hemophilia A (factor VIII), Von Willebrands Disease (factor VIII) and Hemophilia B (factor IX))]. Specifically excluded are human [neoplasias of the lymphoreticular system (lymphomas, reticuloendothelioses, or plasma cell dyscrasias)].

(b) Human [malignant neoplastic] diseases. This field includes all forms of human (cancer, including but not limited to skin cancers and all solid tumors]. This field also includes all forms of human [cancers of the hematopoietic tissues (the leukemias), Hodgkins Disease and Non-Hodgkins Lymphoma].

c) relating to a syndrome (AIDS) characterized by opportunistic infections occuring as a result of profound
deficiency of the helper – T4 lymphocytes (CD4 lymphocytes). At any time during the life of this Agreement the definition of AIDs shall be that definition currently in use by the Centers for Disease Control, Atlanta, Georgia].

(d) All human [infectious diseases other than HIV]. This Field includes: [human viral diseases (besides HIVs, human bacterial, yeast and other microorganism based diseases, and all other human infectious diseases.

License Grant

Licensor and Licensee of Japan established a collaborative relationship on September 26, 1997 to conduct research and develop certain gene therapy products for the treatment of human cancer,  which Licensee shall have the right to commercialize in the Territory and Licensor shall have the right to commercialize outside the Territory.

With this new commercialization license, Licensor grants to the Licensee of Japan an exclusive, license under the Licensor Technology and Licensors interest in the Joint Technology, to make, have made  use, sell and otherwise commercialize Collaboration Products for all uses in the Field in the Territory.

License Property

Licensor has expertise in the field of gene therapy and is developing novel, proprietary materials and methods for use in the treatment of human cancer.

CD vector shall mean either a DART Vector or a GV11 Vector, in either case that incorporates the nucleic acid sequence for cytosme deaminase and does not incorporate any other nucleic acid sequence encoding a protein intended for or otherwise conferring therapeutic benefit.

Gene Therapy shall mean the introduction of a nucleic acid sequence encoding a protein intended for or otherwise conferring therapeutic benefit into a person for therapeutic purposes by in vivo introduction for incorporation into cells of such person, or by ex vivo introduction into cells for transfer into a person.

Field of Use

TheField shall mean Gene Therapy for the treatment of human cancer, Excluding any use of any DART Vector delivered by means of direct injection into a tumor.

License Grant

Each of the Parties agree to perform the work designated in the Work Plan and Budget to be performed by it, respectively, in the course of the Research and Development Program substantially within the time frames designated in the Work Plan and Budget.  Licensee will act as the primary Vaccine Developer under the Work Plan and Budget. Licensor and Licensee will be entitled to involve one or more subcontractors in the performance of such work, provided that each such subcontractor is approved in writing for such purpose by all parties to this Agreement, which approval shall not be unreasonably withheld or delayed. Licensor acknowledges that later steps and phases of work in the Research and Development Program, and the time frames therefor, will depend in part upon the results achieved in earlier steps and phases. The responsibility of Licensor and Licensee hereunder shall be satisfied by their devotion to the Research and Development Program of the efforts called for from them, respectively, in the Work Plan and Budget; neither of Licensor nor Licensee warrants or commits that it will achieve successful or timely results in the conduct of the Research and Development Program.

License Property

Program Inventions shall mean inventions, discoveries, and improvements, patentable or unpatentable, first conceived or reduced to practice by Licensor, Licensee, Licensor, or the subcontractors of any of them during and in the course of work under the Research and Development Program, inclusive of any cell lines or other materials first developed in the course of such work under the Research and Development Program.

Licensee-Controlled Inventions shall mean the inventions disclosed in the United States patents and foreign equivalents and United States and foreign patent applications listed and all divisions, continuations, continuations in part, reissues, or extensions thereof, any periods of marketing exclusivity relating thereto, and any letters patent that issue thereon. It is understood that certain of the Licensee-Controlled Inventions (the Licensed Licensor Rights) are owned by Licensor and are covered by one or more exclusive licenses or sublicenses to Licensee, directly or indirectly.

US 5,858,775 – Adeno-associated virus materials and methods
US 5,786,211 – Adeno-associated virus materials and methods
US 5,658,785 – Adeno-associated virus materials and methods
US 5,139,941 – AAV transduction vectors

Program Vaccines shall mean any AAV (adeno-associated virus) particle-based vector that contains an HIV-1 gene in the recombinant vector genome and that can act as a prophylactic vaccine against HIV-1.

Proprietary Technology shall mean any Background Technology to the extent it has not previously been disclosed in an issued patent or a published patent application. Background Technology shall mean: (i) the rights to make, use, sell, offer for sale, and import the Licensee-Controlled Inventions; (ii) all inventions (whether or not patented or patentable), know-how, techniques, cell lines, data, studies and results of studies and other proprietary information in the possession or control of Licensor at the Effective Date and at any time thereafter during the period in which Licensor remains a direct participant in the Research and Development Program, to the extent bearing upon the Program Vaccines, the Licensee-Controlled Inventions, the Program Inventions, or any of them within the Program Field (as and to the extent the Program Field exists during the period of such direct participation by Licensor); and (iii) know-how and other proprietary information in the possession or control of Licensee at the Effective Date and at any time thereafter during the period in which Licensee remains a direct participant in the Research and Development Program, to the extent useful for the practice of the Licensee-Controlled Inventions within the Program Field (as and to the extent the Program Field exists during the period of such direct participation by Licensee).

Work Plan and Budget shall mean the set of tasks, procedures, protocols, standards, budgets, and target time frames set forth, as such may be amended or supplemented by mutual written agreement of the parties from time to time.

Field of Use

This agreement pertains to the drug industry primarily relating to vaccine development.

Program Field shall mean the manufacture of one or more of the Program Vaccines through the use of the particular combination of Program Inventions and Background Technology as implemented by Licensor and Licensee under this Agreement during and in the course of the Research and Development Program (as the same may be supplemented or improved by or for Licensor with other inventions or technology from sources other than Licensor or Licensee), solely for distribution in the Public Sector, and the use, sale, offer for sale, and import of such Program Vaccines so manufactured in and to the Public Sector. I

The collaboration agreement is to develop a vaccine to prevent AIDS. The vaccine will utilize Targeted Genetics’ Adeno-Associated  Viral Vectors (AAV ) to deliver HIV genes as a novel form of genetic immunization.

License Grant

The English Licensor grants a non-exclusive license to make, use, sell, offer for sale or import Licensed Products under the Licensed Patents, with a right to grant sublicenses.

License Property

The certain patents relate to the Factor IX gene.

The licensed products mean viral vector products, including without limitation adenovirus (AV) and adeno-associated virus (AAV) viral vector products, for in vivo human gene therapy.  Specifically excluded are utilization of non-viral vector products, any ex vivo approach based on the administration of living cells, Factor IX protein produced by or from transgenic animals, and any license rights to make, use, offer for sale, sell, or import Factor IX protein.

Field of Use

This agreement is for the human gene therapy industry.

License Grant

Licensor, a non-profit organization, grants the Israeli Licensee a license under Patent Rights to make, have made, use, sell, offer for sale, and import Licensed Products and to practice Licensed Methods, in the Field within the Territory and during the Term.  The license granted is non-exclusive.

License Property

Licensor has rights in the inventions titled Production of Lysosomal Enzymes in Plant-Based Expression Systems.

Lysosomal storage diseases are a group of about 50 rare inherited metabolic disorders that result from defects in lysosomal function.[1] Lysosomes are sacs of enzymes within cells that digest large molecules and pass the fragments on to other parts of the cell for recycling. This process requires several critical enzymes. If one of these enzymes is defective, because of a mutation, the large molecules accumulate within the cell, eventually killing it.

Field of Use

The Field means all uses.

License Grant

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

License Property

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

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

Field of Use

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

License Grant

Licensor grants a world-wide license under Licensor’s interest in Patent Rights to make, have made, use, and sell Licensed Products and to practice the Licensed Method in the Field of Use.

Licensor also grants the unlimited right to issue sub-sublicenses to third parties to make, have made, use, and sell Licensed Products and to practice the Licensed Method in the Exclusive Field of Use.

License Property

The patents are for Viral Particle Having Altered Host Range;  VSV G Pseudotyped Retroviral Vectors and  Use of VSG-G Pseudotyped Retroviral Vectors for Transfer of Genes into Embryos.

A Licensed Product means any material that is produced using the Licensed Method.

Field of Use

The field means birds and applications to birds, including poultry, especially chickens, turkeys, ducks, and quail.

License Grant

Licensor, an individual, hereby grants an exclusive, even as to Licensor, worldwide license, with the right to sublicense through multiple tiers of sublicense, under Licensors interest in the Licensed Patents for any purpose in the Field, including, without limitation, to develop, make, have made, use, sell, offer for sale, have sold and import Products in the Field.

License Property

The patent relates to methods for transferring genes into the heart and blood vessels.

Field of Use

The Field shall mean the treatment or prevention of heart failure using products that act by the delivery of genes encoding proteins whose role is to regulate calcium uptake or release in the sarcoplasmic reticulum.