Royalty Report: Drugs, Disease, Therapeutic – Collection: 223124

License Grant

Licensor, a non-profit institution, hereby grants to Licensee and its Affiliates a worldwide, non-exclusive license, under Licensor Know-How and Licensed Patents (I) for all internal research and development purposes, including without limitation, the right to make, use and import Licensor Know How and inventions claimed in the Licensed Patents and (ii) to develop, make, use, market, sell, offer for sale, export and import, in the Field of Use, Licensed Products, including without limitation those covered by Valid Claims in the Licensed Patents.

License Property

Intellectual property relates to the induction of gene silencing in mammalian cells through RNAi.

RNA interference, or RNAi, is a naturally occurring mechanism within cells for selectively silencing specific genes, an ability that could become the basis for a whole new class of therapeutic products. The discovery of RNAi has been heralded by many as a major breakthrough, and the journal Science named RNAi the top scientific achievement of 2002 as well as one of the top ten scientific advances of 2003. Because many diseases are caused by the inappropriate activity of specific genes, the ability to silence such genes selectively through RNAi could provide a means to treat a wide range of human diseases.

Licensed Patents means the U.S. Patent Applications listed below and any divisions, continuations, reissues, reexamines, extensions and continuations-in-part applications thereof and any patents issuing thereto; and any and all foreign patents, foreign applications, extensions and supplemental protection certificates or patent applications corresponding thereto having the Principal Investigator as an inventor and claiming the same priority date as a parent application.

Licensor Patents
Serial No.                  Type      Tite                                                                                       Date            Filed Status
PCT/US01/08435      PCT      Methods and Compositions for RNA Interference       3/16/01       Published
09/858,862                CIP       Methods and Compositions for RNA Interference       5/16/01       Pending
09/866,551                CIP       Methods and Compositions for RNA Interference       5/24/01       Pending
10/055,797                CIP       Methods and Compositions for RNA  Interference      1/22/02       Pending

Licensed Product means any product, including but not limited to any lyophilized liquid, sustained release or aerosolized formulation or other formulation, or process for which Licensee, or its Affiliate has received FDA Approval and/or Regulatory Approval, which is made through the use of Licensor Know-How or falls within the scope of a Valid Claim of a Licensed Patent.

Field of Use

The field of Use means all therapeutic uses in humans, including without limitation the diagnosis, prevention and treatment of diseases or conditions and all other healthcare applications. Field of Use shall not include research reagent sales.

License Grant

For the LNP Technology, Canadian Licensor will grant to Licensee a non-exclusive right to use the Licensor Combined Licensed Technology and the Category 1 Patents for use in developing and commercializing Supplemental Field Products. The license granted to Licensee supersedes and replaces the licenses granted to Licensee by Party A and Licensor in the current Supplemental Agreement. Licensee’s right to sub-license will be on a Sublicensable Product-by-Sublicensable Product basis.

License Property

Licensed Product means any product, good, or service covered by a claim of the Licensor controlled Intellectual Property or Licensee controlled Intellectual Property.

LNP intellectual property for use in RNAi therapeutic products using LNP technology.

LNP technology relates to where RNAi therapeutics have the potential to treat a broad number of human diseases by “silencing” disease causing genes. RNAi therapeutics, such as “siRNAs,” require delivery technology to be effective systemically. LNP technology represents the most widely adopted delivery technology for the systemic delivery of RNAi therapeutics. Licensor’s LNP platform is being utilized in multiple clinical trials.  LNP technology encapsulates siRNAs with high efficiency in uniform lipid nanoparticles that are effective in delivering RNAi therapeutics to disease sites in numerous preclinical models.

RNAi Product means a product containing, comprised of or based on siRNA, Dicer Substrates, Multivalent RNA, or any derivatives thereof, which are effective in gene function modulation and designed to modulate the function of particular genes or gene products by causing degradation through RNA interference of a Target mRNA to which such siRNAs or siRNA derivatives or moieties are complementary. For greater clarity, an RNAi Product shall not include Antisense.

siRNA means a double-stranded ribonucleic acid (RNA) composition designed to act primarily through an RNA interference mechanism that consists of either (a) two separate oligomers of native or chemically modified RNA that are hybridized to one another along a substantial portion of their lengths, or (b) a single oligomer of native or chemically modified RNA that is hybridized to itself by self-complementary base-pairing along a substantial portion of its length to form a hairpin.

Supplemental Field Product means a product containing, comprised of, or based on Antisense or Gene Therapy.

Intellectual Property means any and all discoveries, inventions, information, knowledge, know-how, trade secrets, designs, practices, methods, uses, compositions of matter, articles of manufacture, protocols, formulas, processes, assays, skills, experience, techniques, data, reports, and results of experimentation and testing and other scientific or technical information, patentable or otherwise, controlled by a party after the Effective Date.

RNAi (RNA interference) is a revolution in biology, representing a breakthrough in understanding how genes are turned on and off in cells, and a completely new approach to drug discovery and development. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and represents one of the most promising and rapidly advancing frontiers in biology and drug discovery. RNAi is a natural process of gene silencing that occurs in organisms ranging from plants to mammals.

Field of Use

Field of Use means the delivery of an RNAi Product for any and all purposes.

Supplemental Field means the delivery of (i) single-stranded oligonucleotides, either chemically modified or unmodified, acting through the RNase H mechanism or by or other mechanisms of translational arrest but excluding RNA interference involving RISC (“Antisense”) and (ii) DNA plasmids or messenger RNA (mRNA) either chemically modified or unmodified that are transcribed and/or translated into protein and wherein the pharmacological activity is dependent on expression of the protein (Gene Therapy).

License Grant

Licensor will grant to Canadian Licensee a non-exclusive license to any Licensor Intellectual Property for use in RNAi Products.

License Property

Licensed Product means any product, good, or service covered by a claim of the Licensor controlled Intellectual Property or Licensee controlled Intellectual Property.

RNAi Product means a product containing, comprised of or based on siRNA, Dicer Substrates, Multivalent RNA, or any derivatives thereof, which are effective in gene function modulation and designed to modulate the function of particular genes or gene products by causing degradation through RNA interference of a Target mRNA to which such siRNAs or siRNA derivatives or moieties are complementary. For greater clarity, an RNAi Product shall not include Antisense.

RNAi (RNA interference) is a revolution in biology, representing a breakthrough in understanding how genes are turned on and off in cells, and a completely new approach to drug discovery and development. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and represents one of the most promising and rapidly advancing frontiers in biology and drug discovery today which was awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi is a natural process of gene silencing that occurs in organisms ranging from plants to mammals.

LNP intellectual property for use in RNAi therapeutic products using LNP technology.

LNP technology relates to where RNAi therapeutics have the potential to treat a broad number of human diseases by “silencing” disease causing genes. RNAi therapeutics, such as “siRNAs,” require delivery technology to be effective systemically. LNP technology represents the most widely adopted delivery technology for the systemic delivery of RNAi therapeutics. Licensor’s LNP platform is being utilized in multiple clinical trials.  LNP technology encapsulates siRNAs with high efficiency in uniform lipid nanoparticles that are effective in delivering RNAi therapeutics to disease sites in numerous preclinical models.

siRNA means a double-stranded ribonucleic acid (RNA) composition designed to act primarily through an RNA interference mechanism that consists of either (a) two separate oligomers of native or chemically modified RNA that are hybridized to one another along a substantial portion of their lengths, or (b) a single oligomer of native or chemically modified RNA that is hybridized to itself by self-complementary base-pairing along a substantial portion of its length to form a hairpin.

Supplemental Field Product means a product containing, comprised of, or based on Antisense or Gene Therapy.

Intellectual Property means any and all discoveries, inventions, information, knowledge, know-how, trade secrets, designs, practices, methods, uses, compositions of matter, articles of manufacture, protocols, formulas, processes, assays, skills, experience, techniques, data, reports, and results of experimentation and testing and other scientific or technical information, patentable or otherwise, controlled by a party after the Effective Date.

Field of Use

Field of Use means the delivery of an RNAi Product for any and all purposes.

Supplemental Field means the delivery of (i) single-stranded oligonucleotides, either chemically modified or unmodified, acting through the RNase H mechanism or by or other mechanisms of translational arrest but excluding RNA interference involving RISC (“Antisense”) and (ii) DNA plasmids or messenger RNA (mRNA) either chemically modified or unmodified that are transcribed and/or translated into protein and wherein the pharmacological activity is dependent on expression of the protein (Gene Therapy).

License Grant

The English Licensor hereby grants to Licensee and its Affiliates, a non-exclusive, world-wide, sublicensable license under the Licensed Intellectual Property to (i) use, sell, offer for sale, make, have made, import, export and otherwise dispose of Licensed Products in the Licensed Field and (ii) to engage in the research, screening, discovery, development and testing in connection with the Licensed Products in the Licensed Field. The License expressly ex.eludes Licensees and its Affiliates provision of any services to third parties; production and/or sale of kits, diagnostic products or research reagents; products for non-human animal health, agriculture or other industrial applications outside of the Licensed Field.

License Property

Licensed Product shall mean any product incorporating, or designed to deliver to the human body, an SRM, the use, research, development, testing, manufacture, importation, offering for sale or sale of which in the United States would infringe a Valid Claim, but for a license granted under the Licensed Intellectual Property.

Licensed Intellectual Property shall mean US Patent Numbers 8,097,710, 8,258,285, 8,263,569, 8,299,235 and 8,349,607 and US Patent Application Serial Numbers l I/OJ 3,53 l and 12/508,476 and any patents issuing thereupon, including any continuations, divisionals, continuations-in-part, substitutions, reissues, re-examinations, renewals, continued prosecution applications, foreign counterparts and/or extensions of any of the foregoing.

8,097,710 – Gene silencing
8,258,285 – RNA molecules and vectors for gene silencing
8,263,569 – Gene silencing
8,299,235 – RNA molecules and vectors for gene silencing
8,349,607 – Gene silencing

SRM shall mean a short RNA molecule or molecules nominated by Licensee hereof.  Such SRM will be designed to target and modify the expression of a human gene or genes, where such human gene or genes may be any genes selected from across the human genome and may contain a single short RNA molecule or the combination of rwo such short RNA molecules. Such SRM may comprise an SRM series to provide for lead drug candidate and back-up drug candidate (including different formulations, siRNA sequences or siRNA modifications) addressing the same human gene target. Without limitation to the foregoing and for purposes of clarity, an SRM may comprise short RNA molecules designed to target a combination of two (but no more than two) separate gene targets in the human genome.

Field of Use

Licensed Field shall mean the diagnosis, prevention and treatment of disease in humans.

License Grant

The Parties have an agreement to develop technology useful for in vitro and/or in vivo target identification and/or target validation using RNAi and to develop RNAi therapeutic products.

For the RHOA Target, pursuant to the terms of the Original Agreement, Licensor selected the RHOA Target for the development of RNAi Products directed toward such Target (RHOA Products) and Licensee has an opt-in right for further development and commercialization of RHOA Products.

For the royalty bearing products, the Opt-Out Party/Licensor grants the Continuing Party a license under and to Licensor Technology, that is applicable to such Royalty-Bearing Product, to Develop, Manufacture and Commercialize such Royalty-Bearing Product in the Field in the Territory.

For the Profit-Sharing Products:
For Development Licenses, Licensor grants a worldwide license in the Territory, with a right to sublicense to its Affiliates, under Licensor Target Identification and Target Validation RNAi Patent Rights, under Licensors interest in Joint Collaboration Patent Rights and Joint Collaboration Inventions, under Licensor Technology Collaboration Inventions, to Licensor RNAi Technology and under Licensor-Assigned Therapeutic Collaboration Inventions, for the sole purpose of in vitro and/or in vivo target identification and/or target validation research relating to drug discovery and/or development activities of Licensee and/or its Affiliates, including in collaborations with Third Parties in which Licensee and/or its Affiliates has any rights to discoveries made.

For Commercialization Licenses,  Licensor grants a license under and to any and all Licensor Technology to Commercialize Profit-Sharing Products in the Field in the Territory.

The foregoing license shall be Exclusive, Co-exclusive or Non-exclusive, depending upon the time period.

License Property

The developed technology will relate to in vitro and/or in vivo target identification and/or target validation using RNAi and to develop RNAi therapeutic products.

Combination Product means a RHOA Product or an RNAi Therapeutic Product combined with any other clinically active ingredient.

Field of Use

The Field shall mean the treatment and/or prophylaxis of diseases in humans with RNAi Therapeutic Products.

RNA interference, or RNAi, is a naturally occurring mechanism within cells for selectively silencing and regulating specific genes. Since many diseases are caused by the inappropriate activity of specific genes, the ability to silence genes selectively through RNAi could provide a new way to treat a wide range of human diseases. RNAi is induced by small, double-stranded RNA molecules. One method to activate RNAi is with chemically synthesized small interfering RNAs, or siRNAs, which are double-stranded RNAs that are targeted to a specific disease-associated gene. The siRNA molecules are used by the natural RNAi machinery in cells to cause highly targeted gene silencing.

Vascular endothelial growth factor (VEGF), originally known as vascular permeability factor (VPF),[1] is a signal protein produced by cells that stimulates the formation of blood vessels.  To be specific, VEGF is a sub-family of growth factors, the platelet-derived growth factor family of cystine-knot growth factors.

License Grant

The Parties have an agreement to develop technology useful for in vitro and/or in vivo target identification and/or target validation using RNAi and to develop RNAi therapeutic products.

For the royalty bearing products, the Opt-Out Party/Licensor grants the Continuing Party a license under and to Licensor Technology, that is applicable to such Royalty-Bearing Product, to Develop, Manufacture and Commercialize such Royalty-Bearing Product in the Field in the Territory.

For the profit sharing products:
For the Development Licenses, to Develop Profit-Sharing Products in such Program in the Field in the Territory; and Licensor grants a  worldwide, Co-exclusive license, sublicenseable  to its Affiliates, under and to any and all Licensor RNAi Technology, Licensor RNAi Patent Rights, Licensor Collaboration Inventions, Licensor Therapeutic Collaboration IP, Licensors interest in Joint Collaboration IP and Licensor RNAi Novel Target IP which are Controlled by Licensor or the Third Party Licensor or their wholly-owned subsidiaries to Develop Profit-Sharing Products in such Program in the Field in the Territory.

For the Commercialization Licenses, upon Licensees exercise of its U.S. Co-Promotion Option, Licensor grants Licensee a Co-exclusive license under and to any and all Licensor Technology to Commercialize Profit-Sharing Products in the Field in the United States.

For the Manufacturing Licenses, Licensor grants Licensee a non-exclusive license under and to any and all Licensor Technology to Manufacture Profit-Sharing Products in the Field for the Territory.

For the Product Trademark Licenses, Licensor shall grant a Co-exclusive license to use such Product Trademarks to perform its Development obligations under this Agreement with respect to such Profit-Sharing Product.  

Licensor grants a Co-exclusive license to use the Product Trademarks selected by Licensor and approved by the JSC for such Profit-Sharing Product to Commercialize such Profit-Sharing Product in the Field in the United States.

Licensor grants a non-exclusive license in the Territory, under Licensor Broad RNAi Patent Rights that were Controlled by Licensor or the Third Party Licensor or their wholly-owned subsidiaries during the Technology Collaboration Term, Licensor Broad RNAi Technology that was Controlled by Licensor or the Third Party  or their wholly-owned subsidiaries during the Technology Collaboration Term, Licensors interest in Joint Collaboration Patent Rights, and Licensor-Assigned Therapeutic Collaboration Inventions.

License Property

The developed technology will relate to in vitro and/or in vivo target identification and/or target validation using RNAi and to develop RNAi therapeutic products.

Combination Product means a RHOA Product or an RNAi Therapeutic Product combined with any other clinically active ingredient.

Field of Use

The Field shall mean the treatment and/or prophylaxis of diseases in humans with RNAi Therapeutic Products.

RNA interference, or RNAi, is a naturally occurring mechanism within cells for selectively silencing and regulating specific genes. Since many diseases are caused by the inappropriate activity of specific genes, the ability to silence genes selectively through RNAi could provide a new way to treat a wide range of human diseases. RNAi is induced by small, double-stranded RNA molecules. One method to activate RNAi is with chemically synthesized small interfering RNAs, or siRNAs, which are double-stranded RNAs that are targeted to a specific disease-associated gene. The siRNA molecules are used by the natural RNAi machinery in cells to cause highly targeted gene silencing.

License Grant

Licensor hereby grants to Licensee: (i) an exclusive royalty-bearing right and license under the Patent Rights to manufacture, use. offer for sale, sell and import Licensed Products in Field 1, in the Territory, and (ii) an exclusive royalty-bearing right and license under the Patent Rights, subject to such terms and conditions of the Nastech Non-Exclusive License as are applicable and in full force and effect, to manufacture, use, offer for sale, sell and import Licensed Products in Field 2, in the Territory; except that Licensees rights in the Fields with respect to diagnostic uses of Licensed  Products are as set forth in this agreement.

Licensor hereby grants to Licensee an exclusive royalty-bearing right and license under the Patent Rights to manufacture, use, offer for sale, sell and import Licensed Products for human diagnostic uses in the Territory in the Fields solely as expressly set forth in this Agreement. From time to time during the term of this Agreement, Licensee shall have the right, on notice to Licensor, to nominate a specific Licensed Product for diagnostic uses, which Licensed Product shall. at the time of such nomination, be currently the subject of a discovery or development program of Licensee or a Sublicensee or approved for a therapeutic use in one of the Fields.

License Property

Licensed Product means a pharmaceutical product (including, without limitation, kits, component sets or components thereof, regardless of concentration or formulation) that: [A] (i) is Covered by a Valid Claim, (ii) manufactured by a process or used in a method Covered by a Valid Claim, or (iii) contains, as an active ingredient, any substance the manufacture, use, offer for sale or sale of which is Covered by a Valid Claim and [BJ targets
(1) one or more genomes or RNA transcripts of a virus or a pathogenic organism (Pathogen RNA), or (2) RNAs that Localize in. or traffic to, the cytoplasm (Cytoplasmic RNA). For the avoidance of doubt, a product otherwise meeting the criteria set forth that targets a Pathogen RNA and also targets Cytoplasmic RNAs shall be considered a Licensed Product. For the purposes of the definition of Licensed Product, targets means possessing a degree of Watson-Crick base pairing between the Licensed Product and either Pathogen RNA or Cytoplasmic RNA that is sufficient to promote RNA induced silencing. By way of further clarification, Licensed Product shall include a product manufactured in a country in which such manufacture is Covered by a Valid Claim and thereafter exported to and sold in a country in which no Valid Claim exists.

Patent Rights means: (i) those issued United States patents and pending U.S. patent applications and foreign and international equivalents thereto, (ii) U.S., foreign and international patent applications and issued patents claiming inventions related to the subject matter disclosed in the patents and patent applicalions.

11/079,906 – Methods and compositions for the specific inhibition of gene expression by double stranded RNA.
11/079,476 – Methods and compositions for the specific inhibition of gene expression by double stranded RNA.
11/797,296 – Methods and compositions for the specific inhibition of gene expression by double stranded RNA.

Field of Use

Fields means Field 1 and Field 2.  Field 1 means the diagnosis. prevention and treatment of disease in humans: (a) by the delivery of a Licensed Product directly into the eye or onto the surface of the eye, or (b) by the delivery of a Licensed Product directly into the aural canal. (c) by targeting anv virus except: (i) the influenza A, inJluenza B or influenza C virus, (ii) the respiratory syncytial virus, or (iii) the meta pneumovirus.  Field 2 means the diagnosis. prevention and treatment of disease in humans OTHER THAN: (a) by the delivery of a Licensed Product directly into the eye or onto the surface of the eye, or (b) by the delivery of a Licensed Product directly into the aural canal, or (c) by use of a Licensed Product to target any specific virus.

License Grant

The University grants to the Licensee a non-exclusive, worldwide, royalty-bearing license, with the right to sublicense, under its commercial rights in the Patent Rights and Biological Materials to develop, make, have made, use, and sell Licensed Products in the Field.  Licensee shall have the right to grant sublicenses.

License Property

The patents are for RNA Sequence-Specific Mediators of RNA Interference.

Licensed Product means any product that cannot be developed, manufactured, used, or sold without infringing one or more claims under the Patent Rights, or, using or incorporating some portion of one or more Biological Materials.

Biological Materials means the tangible biological materials described in the patents, as well as tangible materials that are routinely produced through use of the original materials, including, for example, any progeny derived from a cell line, monoclonal antibodies produced by hybridoma cells, DNA or RNA replicated from isolated DNA or RNA, recombinant proteins produced through use of isolated DNA or RNA, and substances routinely purified from a source material included in the original materials.

UMMC 01-36 “RNA Sequence-Specific Mediators of RNA Interference” Inventors: David P. Bartel, Philip A. Sharp, Thomas Tuschl, and Philip D. Zamore
I. United States Patents and Application
USSN 60/265232 entitled “RNA Sequence-Specific Mediators of RNA Interference”

USSN 09/821832 entitled “RNA Sequence-Specific Mediators of RNA Interference”
PCT/US01/10188 entitle “RNA Sequence-Specific Mediators of RNA Interference”

Field of Use

The field of use is therapeutics limited to the narrowed fields of other Medical School license agreements; specifically, using RNAi to inhibit HCMV Immediate Early (IE) gene expression in Retinitis applications, using RNAi to inhibit mutant SOD 1 gene expression in Amytrophic Lateral Sclerosis (ALS) applications, and using RNAi to inhibit gene targets implicated in Type II Diabetes and Obesity under the rights of Medical School in any patent rights claiming those inventions.

License Grant

The English Licensor hereby grants to Licensee, and its Affiliate(s) who have confirmed to Licensee their agreement in writing to be bound (to Licensor) by the terms of this Licence Agreement which specifically apply to Affiliates, with a copy to be sent to Licensor, a licence in the Field throughout the Territory under the Licensor Patent Rights to research, develop, have developed, use, keep, make, have made, import, have imported, sell, have sold and otherwise dispose or offer to dispose of Licensed Products.

License Property

Licensor Patent Rights means the patent applications referred to in agreement and all Patent Rights deriving priority from them and all Patent Rights deriving priority from such Patent Rights.  

Pending US Patent #10/150426 'Inhibiting gene expression with dsRNA' for therapeutic applications.

Licensed Products means product or products which, or the process of production of which, or the use of which falls within the scope of a Valid Claim of the Licensor Patent Rights and Licensed Product shall be construed as any one of them.

Field of Use

This agreement pertains to the drug industry in the field that means the development of RNAi therapeutic products for the treatment of human disease (including by means of gene therapy).

License Grant

The Parties are entering a collaborative research program to define the function and pharmaceutical utility of selected secreted proteins for the discovery of Therapeutic Proteins.

For the Grant of Rights and Licenses in the Research Field,  Licensor grants to Licensee and its Affiliates, within the Territory, a non-exclusive right and license, without any right to sublicense, under the Licensor Patent Rights and Know-How with respect to Research Program Gene Products and, to the extent licensed to Licensee in the Commercialization Field, Licensed Gene Products solely in the Research Field.

For the Grant of Rights and Licenses to Therapeutic Proteins in the Commercialization field, Licensor  grants to Licensee and its Affiliates, within the Territory, a non-exclusive license, with the right to sublicense under Licensee Know-How with respect to Licensed Gene Products to discover, develop, make, have made, import, use, have used, offer for sale, sell and have sold Therapeutic Proteins in the Commercialization Field and an exclusive license, with the right to sublicense, under the Licensor PatentbRights and Licensors interest in any Joint Patent Rights and Joint Know-How with respect to Licensed Gene Products, including any Therapeutic Protein that incorporates or is derived from any such Licensed Gene Product, to discover, develop, make, have made, import, use, have used, offer for sale, sell and have sold Therapeutic Proteins in the Commercialization Field.

For the Grant of Rights and Licenses to Products Other than Therapeutic Proteins in the
Commercialization Field, Licensor grants to Licensee and its Affiliates, within the Territory, a non-exclusive license, with the limited right to sublicense, under the Licensor Patent Rights, Know-How and Licensors interest in any Joint Patent Rights and Joint Know-How with respect to Licensed Gene Products, including any Diagnostic Product that incorporates or is derived from any such Licensed Gene Product, to discover, develop, make, have made, import, use, have used, offer for sale, sell and have sold Diagnostic Products and Drug Products in the Commercialization Field.

License Property

Licensor has rights for certain methods of producing and analyzing the phenotypes of gene knockout mice for the discovery of gene and protein function.

Licensor Know-How means trade secrets and other rights in or to Research Program Gene Products and Licensed Gene Products.

Diagnostic Product means any product or service derived from or directed to Research Program Gene Products or Licensed Gene Products for use in the Diagnostic Field.

Therapeutic Protein shall mean any product or service, including gene therapy, which uses a protein, peptide or polypeptide which is a Gene Product in the treatment or prevention of any disease, state or condition in humans.

Licensed Gene Product means any Gene Product for which Licensee and /or Licensor is granted a license in the Commercialization Field.

Field of Use

Commercialization Field means, collectively, the Diagnostic Field and the Therapeutic Field.

Diagnostic Field means in vitro or in vivo diagnosis or pre-screening of human patients to determine therapeutic eligibility for a Product in the Therapeutic Field or for monitoring human patients receiving a Product in the Therapeutic Field; provided, however, that the Diagnostic Field excludes the commercialization of diagnostic products for which no Regulatory Approval has been obtained and which are not the subject of an active application for Regulatory Approval, multi-gene diagnostic products, and diagnostic products directed to quantitative detection of relative RNA transcript abundance of multiple RNA species.

Research Field means use by Licensee, Licensor and their respective Affiliates, at the internal research facilities of Licensee, Licensor and their respective Affiliates, for research directed toward the discovery, identification, selection, or characterization of Products.

License Grant

Party A, a Canadian University, hereby assigns to Licensee all of Party A’s right, title and interest in and to U.S. Patent Application No. 11/807,872, with no additional payment due to Party B and will record such assignment with the U.S. Patent and Trademark Office.

The Parties shall direct their respective counsel to execute Stipulations of Dismissal with Prejudice dismissing all claims and counterclaims that were or could have been asserted in the Massachusetts State Court Action, U.S. Infringement Action, Canadian Infringement Action, and B.C. Action, and in the case of the Interference Proceeding, a Request for Adverse Judgment providing that Licensee concedes priority to Party A with respect to all claims that correspond to Counts 1-5, i.e., claims 34, 36, 38, and 40-43 of Party A U.S. Application 11/807,872; claims 1-6, 8, 10, 12-18, 21-22, and 32-33 of Licensee U.S. Patent 7,718,629; and claims 32-38 of Licensee U.S. Application 13/165,568, and requesting that an adverse judgment be entered against Licensee as to these claims and priority be awarded to Party A for U.S. Application 11/807,872.

License Property

U.S. Patent 7,718,629 – Compositions and methods for inhibiting expression of Eg5 gene
Patent certains to intellectual property (IP) elements related to lipid nanoparticle (LNP) technology for RNAi therapeutics.

RNAi (RNA interference) is a revolution in biology, representing a breakthrough in understanding how genes are turned on and off in cells, and a completely new approach to drug discovery and development.

Field of Use

By harnessing the natural biological process of RNAi occurring in our cells, the creation of a major new class of medicines, known as RNAi therapeutics, is on the horizon.

License Grant

Licensor, a non-profit biomedical research company, grants to Licensee an exclusive, royalty-bearing license, with the right to grant sublicenses pursuant to Section 2.5, in the Territory under and to use the Licensed Intellectual Property to research, develop, make, have made, use, sell, offer for sale and import Licensed Products in the Field.

License Property

Licensed Patents means (a) the Patents listed below to this Agreement; (b) any and all Patents that claim Licensed Know-How and are Controlled by Licensor on the Effective Date and during the Term, including without limitation Licensors interest in any Joint Patent that claims Licensed Know-How; (c) all divisionals, continuations (in whole or in part, including without limitation conversions of provisional applications into utility patent applications), and substitutions of any of the preceding, and any letters patent and/or registrations (including, without limitation, all reissues, renewals, extensions, confirmations, re-examinations, supplementary protection certificates) that may be granted on any of the foregoing; and ( d) any and all United States and foreign counterparts of any of the foregoing.

Licensed Patents:
U.S. provisional patent application USSN 60/965,135 entitled Therapeutic Compositions for Treatment of Inflammation of Ocular and Adnexal Tissues

PCT/US08/09776 filed on 15.08.2008 claiming priority to Provisional 60/965,135, filed on August 16 2007. Published on February 26, 2009 WO/2009/025763, entitled Therapeutic Compositions for Treatment of Inflammation of Ocular and Adnexal Tissues

Provisional 61/143,561 filed January 09. 2009 entitled Therapeutic Compositions For Treatment of Corneal Disorders

Licensed Product means any product the manufacture, use or sale of which would, but for the licenses granted in this Agreement, infringe a Valid Claim of a Licensed Patent.

An amendment to the license agreement dated 01/01/1990 is amended by deleting it in its entirety the above Licensed Patent Information and replacing it hereto:
Licensed Patents:
U.S. Patent Appln. No. 121685.510
U.S. Patent Appln. No. 13/183,231

Field of Use

The patent applications cover methods of treating diseases of the eye using an inhibitor of the inflammatory cytokine IL-1.

License Grant

Licensor grants a non-exclusive right and license under the Licensor Patent Rights for the sole and exclusive purposes of Researching, Developing and Commercializing Licensed RNAi Products for the Target in the Field in the Territory.

License Property

Licensor has intellectual property covering technology useful for the discovery, development, manufacture, characterization, or use of therapeutic products that function through RNA interference (RNAi).

Patents include short double-stranded RNAs as therapeutics.

Licensees target is RTP 801, or, DNA•damage-inducible transcript 4.

Field of Use

Field means the use of therapeutic RNAi Products against the Target for the treatment in humans of ocular diseases, loss of hearing, emphysema and pressure sores.

Emphysema is a long-term, progressive disease of the lungs that primarily causes shortness of breath due to over-inflation of the alveoli (air sacs in the lung). In people with emphysema, the lung tissue involved in exchange of gases (oxygen and carbon dioxide) is impaired or destroyed.

License Grant

The Parties are entering a collaborative research program to define the function and pharmaceutical utility of selected secreted proteins for the discovery of Therapeutic Proteins.

For the Grant of Rights and Licenses in the Research Field, Licensor grants to Licensee and its Affiliates, within the Territory, a non-exclusive right and license, without any right to sublicense, under the Licensor Patent Rights and Know-How with respect to Research Program Gene Products and, to the extent licensed to Licensee in the Commercialization Field, Licensed Gene Products solely in the Research Field.

For the Grant of Rights and Licenses to Therapeutic Proteins in the Commercialization field,  Licensor grants to Licensee and its Affiliates, within the Territory, an exclusive license, with the right to sublicense, under the Licensor Patent Rights, Licensor KnowHow and Licensors interest in any Joint Patent Rights and Joint Know-How with respect to Licensed Gene Products, including any Therapeutic Protein that incorporates or is derived from any such Licensed Gene Product, to discover, develop, make, have made, import, use, have used, offer for sale, sell and have sold Therapeutic Proteins in the
Commercialization Field.

For the Grant of Rights and Licenses to Products Other than Therapeutic Proteins in the Commercialization Field,  Licensor grants to Licensee and its Affiliates, within the Territory, a non-exclusive license, with the limited right to sublicense, under the Licensor Patent Rights, Licensor Know-How and Licensors interest in any Joint Patent Rights and Joint Know-How with respect to Licensed Gene Products, including any Diagnostic Product that incorporates or is derived from any such Licensed Gene Product, to discover, develop, make, have made, import, use, have used, offer for sale,sell and have sold Diagnostic Products andDrug Products in the Commercialization Field.

License Property

Licensor has rights for certain methods of producing and analyzing the phenotypes of gene knockout mice for the discovery of gene and protein function.

The Cre-Lox Patents means United States patent number 4,959,317, any foreign counterpart patents and patent applications.

Diagnostic Product means any product or service derived from or directed to Research Program Gene Products or Licensed Gene Products for use in the Diagnostic Field.

Therapeutic Protein shall mean any product or service, including gene therapy, which uses a protein, peptide or polypeptide which is a Gene Product in the treatment or prevention of any disease, state or condition in humans.

Licensed Gene Product means any Gene Product for which Licensee and /or Licensor is granted a license in the Commercialization Field.

A protein that is extruded from inside the cell through the cell membrane is referred to as a 'secreted protein.' These proteins contain a signal sequence that guides them from interior of the cell through the cell membrane and into the general circulation. Many secreted proteins, such as cytokines and hormones, are of therapeutic importance and have been commercialized by other companies to be very successful therapeutic agents.

Field of Use

Commercialization Field means, collectively, the Diagnostic Field and the Therapeutic Field.

Diagnostic Field means in vitro or in vivo diagnosis or pre-screening of human patients to determine therapeutic eligibility for a Product in the Therapeutic Field or for monitoring human patients receiving a Product in the Therapeutic Field; provided, however, that the Diagnostic Field excludes the commercialization of diagnostic products for which no Regulatory Approval has been obtained and which are not the subject of an active application for Regulatory Approval, multi-gene diagnostic products, and diagnostic products directed to quantitative detection of relative RNA transcript abundance of multiple RNA species.

Research Field means use by Licensee, Licensor and their respective Affiliates, at the internal research facilities of Licensee, Licensor and their respective Affiliates, for research directed toward the discovery, identification, selection, or characterization of Products.

License Grant

University hereby grants and Licensee hereby accepts an Exclusive license under the Licensed Patents and Licensed Materials to make, have made, import, use, lease, sell and offer for sale and otherwise commercialize and exploit Licensed Products in the Licensed Territory, and practice any method process or procedure within the Licensed Patents in the Licensed Territory.  Said license is Exclusive, including the right to sublicense  in the Licensed Field of Use for a term commencing as of July 1, 1997 and ending on the expiration of the last to expire of the Licensed Patent(s).  University shall have the right to practice the Invention(s) and use the Technology for its own bona fide research, including sponsored research and collaborations. University shall have the right to publish any information included in Licensed Materials and Licensed Patent(s).

License Property

Licensed Product(s) means any product or part thereof in the Licensed Field of Use, the manufacture, use, or sale of which:

(a)
Is covered by a valid claim of an issued, unexpired Licensed Patent(s) directed to the Invention(s). A claim of an issued, unexpired Licensed Patent(s) shall be presumed to be valid unless and until it has been held to be invalid or unenforceable by a final judgment of a court of competent jurisdiction from which no appeal can be or is taken or is disclaimed, or rejected or found invalid or unenforceable in a reissue application or re- examination proceeding or otherwise;
  
(b)
Is covered by any claim being prosecuted in a pending application directed to the Invention(s); or

(c)
Incorporates any of the Licensed Materials.

Licensed Patent(s) means any (i) U.S. patent application Serial Number 270,631 filed July 1, 1994 (issued on July 22, 1997 as U.S. Patent Number 5,650,135), (ii) all divisions, substitutions, and continuations in whole or part of any of the preceding, (iii) all foreign patent applications corresponding to or claiming priority from (including International Application Number PCT/US95/15040 and all national applications claiming priority therefrom), and (iv) all U.S. and foreign patents issuing on any of the preceding, including patents of addition, reexaminations, reissues and extensions.

5,650,135 – Non-invasive localization of a light-emitting conjugate in a mammal

Licensed Materials means those biological materials listed, and such other agreed materials as University may provide to Licensee during the term of this Agreement, which shall be added.
– Individual components of light systems (Vectors, genes and gene fragments)
– Bacteria
– Tumor cells
– Indicator cells for HIV
– Transgenic mouse lines

Field of Use

Licensed Field of Use means all uses.

License Grant

Licensor hereby grant to Licensee an exclusive (even to Licensor), royalty-bearing, freely sublicenseable license in the Territory under the Licensed Patents and Information for  all purposes, including without limitation, to develop, use, make, have made, import, have imported, export, have exported, offer for sale, have sold and sell Licensed Products.

License Property

Licensed Product means a product that utilizes or incorporates a Valid Claim for the therapeutic treatment of a specific fibrotic human disease, which product has been approved after the Effective Date for the therapeutic treatment of such specific fibrotic human disese by the United States Food and Drug Administration (FDA) and/or any Regulatory Agenciies through the granting of a New Drug Application (NDA) or equivalent foreign approval document.

Licensed Patents means that certain U.S. Patent No. 5,310,562; and all corresponding foreign patent applications and patents throughout the Territory, including any and all divisions, re-issues, re-examinations, renewals, continuations and substitutes in whole or in part of such patents and patent applications in the Territory with respect to the anti-fibrotic  uses of Pirfenidone; and all Patents defined. The Licensed Patents shall specifically exclude U.S. Patent No. 5,962,478 titled Tumor Necrosis Factor Alpha.
5,310,562 – Composition and method for reparation and prevention of fibrotic lesions

Patents means all of Licensors (a) anti-fibrotic, Pirfenidone patent applications heretofore or hereafter filed or having legal force in any country including without limitation divisionals, continuations, continuation-in-part and provisional applications; (b) issued, unexpired anti-fibrotic Pirfenidone patents in any country, including utility, model and design patents and certificates of invention; and (c) substitutions, extensions, reissues, renewals, and supplementary protection certificates with respect to any such issued patents. For clarity, such patent applications and patents shall include those owned, as well as those controlled with the right to grant licenses, by any of Licensors. The Patents shall not include patent applications and patents to the extent claiming uses of Pirfenidone other than for anti-fibrotic uses, nor uses of compounds for anti-fibrotic applications other than Pirfenidone.

Field of Use

This agreement pertains to the drug industry relating to products potentially useful in the prevention, mitigation and treatment of fibrotic and other diseases.

Fibrosis, also known as Fibrotic scarring, is a pathological wound healing in which connective tissue replaces normal parenchymal tissue to the extent that goes unchecked, leading to considerable tissue remodelling and the formation of permanent scar tissue.