Royalty Report: Drugs, Disease, HIV / AIDs – Collection: 204321

License Grant

Licensor grants an exclusive, sublicensable right and license under the Intellectual Property Controlled by Licensor which is reasonably necessary or useful to make, have made, use, sell, offer for sale and import any Licensee Vaccine funded and developed under the Development Program for the Developing World. For the avoidance of doubt, the foregoing license shall permit Licensee to Manufacture Licensee Vaccine outside the Developing World but solely to the extent such Licensee Vaccine is used, distributed and sold within the Developing World.

License Property

Licensor possesses certain skills and owns or has rights to certain patents, patent applications, other valuable technology and know how relating to vector design, production, and purification of AAV vectors which can aid Licensee in its objectives, and may develop or acquire additional such rights.

AAV means an adeno-associated virus composed of a viral capsid comprising three proteins known as VP1, VP2, and VP3, wherein the genome is a single strand DNA molecule of approximately 4.5kb in size, flanked by inverted terminal repeats (ITRs) of approximately 145bp designated ITRs.

AAV Vector means a recombinant AAV where the approximately 4.5kb genome has been replaced by HIV sequences of interest under the control of appropriate regulatory sequences.

Licensor Licensed Patent Rights means all Patent Rights to the extent of the subject matter of such rights which claim AAV Vector compositions, methods of making AAV Vector compositions, or use of AAV Vector compositions, to the extent Controlled (but not owned) by Licensor as a result of being licensed to Licensor by a Third Party Licensor under one or more Third Party Agreements, and all improvements.

Licensor Patent Rights means all Patent Rights Controlled by Licensor to the extent of the subject matter of such rights which claim AAV Vector compositions, methods of making AAV Vector compositions, or use of AAV Vector compositions solely to the extent that such rights are owned, but not in-licensed, solely or jointly by Licensor as of the Initial Agreement Date, or claim priority to any such Patent Rights, or claim any invention conceived during the Development Period which conception arose, at least in part, from activities funded by Licensee under the Initial Agreement or this Agreement, and all improvements.

Field of Use

Licensee has, as one of its principal objectives, the acceleration of development of vaccines against HIV for use and distribution in the Developing World.

License Grant

Licensor grants a non-exclusive, sublicensable right and license under the Licensor Know How and Licensor Patent Rights which are reasonably necessary or useful to make, have made, use, sell, offer for sale and import any AAV product, including without limitation Licensee Vaccines worldwide; provided, however, Licensor retains an exclusive right and license to Develop, Manufacture and Commercialize any Licensor Vaccine for the Developing World.

License Property

Licensor Know How means all unpatented Know How which is Controlled by Licensor and has been developed, solely or with a Third Party, by Licensor either under the Development Program or outside of the Development Program but during the Development Period through the use of Program Materials; and which, in each case, is reasonably necessary or useful for the Development, Manufacture and/or Commercialization of an AAV product; provided, however, that, in any event, Licensor Know How shall exclude any Joint Know How and Patent Rights.

Licensor Patent Rights means Patent Rights Controlled by Licensor to the extent of the subject matter of such rights that claim any invention which was conceived of during the Development Period which conception arose, at least in part, from activities conducted as part of the Development Program or through the use of Program Materials; and,  which is reasonably necessary or useful for the Development, Manufacture and/or Commercialization of an AAV product.

AAV means an adeno-associated virus composed of a viral capsid comprising three proteins known as VP1, VP2, and VP3, wherein the genome is a single strand DNA molecule of approximately 4.5kb in size, flanked by inverted terminal repeats (ITRs) of approximately 145bp designated ITRs.

Field of Use

The field of this agreement is the development of vaccines against HIV for use and distribution in the Developing World.

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

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 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

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

Licensor grants sublicense rights to the Patent Rights, granted to Licensor in the Amended and Restated Exclusive License Agreement, under said rights to make, have made, use, manufacture and sell products using the Joint Patent Filing technology.

License Property

Licensor has been granted worldwide exclusive license to the Joint Patent Filing, which includes the 03-24 Technology and 03-111 Technology.

Licensed Product shall mean any HIV vaccine product other than the HIV Vaccine that cannot be developed, manufactured, used, or sold without infringing one or more Valid Claim under the Patent Rights.

The patents are titled: Polyvalent, Primary HIV -1 Envelope Glycoprotein DNA Vaccine, and, Polyvalent DNA and Protein Vaccines.

This technology is a DNA-based HIV vaccine that incorporates the 03-24 Technology and the 03-111 Technology.  Invention disclosure number 03-24 is entitled Primary and Polyvalent IIlV-1 Envelope Glycoprotein DNA Vaccines.  And HIV protein boost technology invention is referred to as 03-111.

New Vaccine shall mean any HIV vaccine other than the HIV Vaccine.

Field of Use

The Field shall mean all HIV vaccines.

License Grant

This amendment updates the grant, royalties, patents, and products.

The grant is replaced in its entirety with:
The University grants to Licensee exclusive licenses under Patent Rights to make, use, sell, offer for sale, and import Patent Products and Vaccine Adjuvant Product and to practice the Patent Method. Licensee is expressly prohibited from selling a Derived Product or Vaccine Adjuvant Product to any third party, except that Licensee may sell a Vaccine Adjuvant Product to the Third Party.

The University also grants to Licensee the right to issue sublicenses to third parties to make, use, sell, offer for sale, and import Patent Products and practice the Patent Method, provided Licensee retains current exclusive rights under this Agreement.

The University also grants to Licensee the right to issue sublicenses to the Third Party to make, use, sell, offer for sale, and import Vaccine Adjuvant product and practice the Patent Method, provided Licensee retains current exclusive rights under this Agreement.

License Property

With this amendment:
The patents include Biologically Active Composition Having A Nanocrystalline Core; Human Immunodeficiency Virus Decoy; and, Targeted Transfection Nanoparticles.

The Drug Delivery Product means a Licensed Product, which would, were it used or sold in the United States, require marketing approval by an appropriate regulatory agency for the use in pharmaceutical preparations to facilitate the therapeutic delivery of drugs in humans.

Vaccine Adjuvant Product means a Licensed Product that, when added as part of a Vaccine Product, improves the immune response so that less of a Vaccine Product is needed to produce more antibodies.

Vaccine Product means a Licensed Product, which would, were it used or sold in the United States, require marketing approval by an appropriate regulatory agency for any preparation containing a suspension of dead, attenuated, or otherwise modified microorganisms, e.g. viruses, bacteria, or rickettsiae, or parts thereof, that is used to produce an immunity against a disease in humans or other animals by stimulating the production of antibodies.

Derived Product means any product that is made by using a composition of matter claimed under Patent Rights or by practicing the Patent Method to make a final product regardless of the number of steps in the process or the number and types of compositions of matter, e.g., intermediate compounds, that are involved in making the final product. A Derived Product also means any product that is made by using a composition of matter claimed under Patent Rights whether or not that composition of matter is directly incorporated or a part of the final product.

Field of Use

Licensed Products means:
– a kit, composition of matter, material, product, or Derived Product;
– a kit, composition of matter, material, product, or Derived Product to be used in a manner requiring the performance of the Patent Method; or
– a kit, composition of matter, material, product, or Derived Product produced by the Patent Method;

The Excluded Field means any field other than a Vaccine Product, Drug Delivery Product, and Vaccine Adjuvant Product.

Patents are in fields of use initially pertaining to: (1) vaccine adjuvants; (2) vaccine constructs or combinations for use in immunization against herpes virus; (3) drug delivery systems; and (4) red blood cell surrogates.

License Grant

The Licensor and Licensee of Denmark are working and cooperating with each other to conduct a joint program for the discovery and development of a vaccine.

The Research and Development Program will involve the systematic design and development of the Program Vaccine for use in the Field. The scope and goals of the Research and Development Program are subject to modification.

Licensor grants the Licensee of Denmark a worldwide, nonexclusive, non sublicensable and nontransferable license during the Research Term to practice the Licensor Background Technology, the Licensor Patent Rights and the Joint Patent Rights, solely in connection with activities to be performed by Licensor under the Research and Development Program.

Licensor grants a worldwide, non-exclusive and nontransferable license, with rights to sublicense, under the Licensor Background Technology, the Licensor. Patent Rights and the Joint Patent Rights, to make, have made, use, sell, offer for sale and import Licensee-Combined Vaccines or the Program Vaccines.

License Property

The licensed property includes proprietary Modified Vaccinia Ankara MVA technology to design vaccines.  Also developed vaccine products including those based on viral vectors, and T-cell epitope.

Field of Use

The Field shall mean any use of a vaccine product for the treatment or prevention of HIV in humans.

License Grant

The parties agree that upon the Joint Patent Filing, the 03-111 Technology shall become part of the Patent Rights as defined in the 03-24 License Agreement. Licensor agrees that the inclusion of the 03-111 Technology into the 03-24 License Agreement shall occur without further compensation to University or Licensor, except as specified in this Agreement, and at no additional cost to Licensee.  Licensor shall also grant Licensee a non-exclusive, royalty-bearing license to any additional technologies outside of the 03-24 Technology and the 03-111 Technology that are owned or licensed to Licensor (including those acquired by Licensor pursuant to its right of first refusal under the University Subcontract) and that result from work done by University under the University Subcontract for a DNA-based HIV vaccine with protein boost and that are necessary or advantageous to Licensee for the development or commercialization of the HIV Vaccine, with the amount of the royalty to be established in the Definitive Collaborative Agreement and to be negotiated in good faith by the parties. University shall grant Licensee a right of first negotiation to obtain a royalty-bearing license to University exclusive or non-exclusive rights to any additional technology outside of the 03-24 Technology and 03-111  technology that are owned by University and have not been acquired or licensed to Licensee pursuant to its right of first refusal under the University Subcontract and that result from work done under the University Subcontract and that are necessary or advantageous to Licensee for the development or commercialization of the HIV Vaccine. Licensor shall represent that it does not currently own or have any other rights to any other technology that would be infringed by the development or commercialization of the HIV Vaccine.

License Property

The '03-24 Technology – U.S. Patent Application Serial Number 60/430,732 (the '03-24 Patent Filing') with the United States Patent and Trademark Office covering a foundational HIV vaccine technology invention referred to by University as UMMC 03-24.

The '03-111 Technology – U. S. Patent Application Serial Number 60/503,907 (the '03-111 Patent Filing') covering an HIV protein boost technology invention referred to by University and Licensor as UMMC 03-111.

Field of Use

This agreement pertains to HIV vaccine.

License Grant

The parties agree that upon the Joint Patent Filing, the 03-111 Technology shall become part of the Patent Rights as defined in the 03-24 License Agreement. Licensee agrees that the inclusion of the 03-111 Technology into the 03-24 License Agreement shall occur without further compensation to University or Licensee, except as specified in this Agreement, and at no additional cost to Licensor.  Licensee shall also grant Licensor a non-exclusive, royalty-bearing license to any additional technologies outside of the 03-24 Technology and the 03-111 Technology that are owned or licensed to Licensee (including those acquired by Licensee pursuant to its right of first refusal under the University Subcontract) and that result from work done by University under the University Subcontract for a DNA-based HIV vaccine with protein boost and that are necessary or advantageous to Licensor for the development or commercialization of the HIV Vaccine, with the amount of the royalty to be established in the Definitive Collaborative Agreement and to be negotiated in good faith by the parties. University shall grant Licensor a right of first negotiation to obtain a royalty-bearing license to University exclusive or non-exclusive rights to any additional technology outside of the 03-24 Technology and 03-111  technology that are owned by University and have not been acquired or licensed to Licensor pursuant to its right of first refusal under the University Subcontract and that result from work done under the University Subcontract and that are necessary or advantageous to Licensor for the development or commercialization of the HIV Vaccine. Licensee shall represent that it does not currently own or have any other rights to any other technology that would be infringed by the development or commercialization of the HIV Vaccine.

License Property

The '03-24 Technology – U.S. Patent Application Serial Number 60/430,732 (the '03-24 Patent Filing') with the United States Patent and Trademark Office covering a foundational HIV vaccine technology invention referred to by University as UMMC 03-24.

The '03-111 Technology – U. S. Patent Application Serial Number 60/503,907 (the '03-111 Patent Filing') covering an HIV protein boost technology invention referred to by University and Licensee as UMMC 03-111.

Field of Use

The HIV vaccine technology that Licensee have licensed is based upon a unique mixture of human HIV-1 primary isolates from several genetic subtypes of HIV. This polyvalent naked DNA (isolated, purified DNA) vaccine approach has the potential advantages of maintaining efficacy despite the high mutation rate of HIV, a broader immune response against divergent HIV-1 glycoproteins and the possible ability to neutralize a wide spectrum of HIV-1 viruses.

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, 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

Licensor grants, during the Term, an exclusive license, under the Technology to Licensee Products in the Field.

License Property

This technology includes, without limitation, MYDICAR® (AAV1/SERCA2a).

Mydicar is a genetically targeted enzyme replacement therapy being studied for use in patients with severe heart failure.  It is designed to increase the level of SERCA2a, a sarcoplasmic endoplasmic reticulum calcium (Ca2+) ATPase found in the membrane of the sarcoplasmic reticulum (SR). The SERCA2a gene is delivered to the heart via an adeno-associated viral vector.

Field of Use

The field is human therapeutics and prophylactics.

License Grant

The Licensor of Denmark and the Licensee are working and cooperating with each other to conduct a joint program for the discovery and development of a vaccine.

The Research and Development Program will involve the systematic design and development of the Program Vaccine for use in the Field. The scope and goals of the Research and Development Program are subject to modification.

Licensor grants a worldwide, nonexclusive, nonsublicensable and nontransferable license during the Research Term to practice the Licensor Background Technology, the Licensor Patent Rights and the Joint Patent Rights, solely in connection with activities to be performed by Licensee under the Research and Development Program.

Subject to the exercise by Licensee of the Combination Option or Option, Licensor grants to a worldwide, non-exclusive and non-transferable license, with rights to sublicense, under the Licensor Background Technology, the Licensor Patent Rights and the Joint Patent Rights, to use, sell, offer for sale and import Combined Vaccine or the Program Vaccine during the Term.

License Property

The licensed property includes proprietary Modified Vaccinia Ankara MVA technology to design vaccines.  Also developed vaccine products including those based on viral vectors, and T-cell epitope.

Field of Use

The Field shall mean any use of a vaccine product for the treatment or prevention of HIV in humans.

License Grant

Medical School and Licensor each hereby grants to Company and its Affiliates an exclusive, worldwide, royalty-bearing license (with the right to sublicense) under their respective commercial rights in the Patent Rights and Biological Materials to develop, make, have made, use, and sell Licensed Products in the Field.
                                                                    
Medical School hereby grants to Company and its Affiliates a non-exclusive, royalty-bearing license (with the right to sublicense) under its commercial rights in the Related Technology to develop, make, have made, use, and sell Licensed Products in the Field and Licensor hereby consents to such grant by Medical School.

Licensor hereby grants to Company and its Affiliates the right to acquire a non-exclusive, worldwide, royalty-bearing license (with the right to sublicense) to any Licensor Related Technologies. Licensor shall promptly disclose in writing to Company each of the Licensor Related Technologies at the time such technologies are acquired or licensed by Licensor. Licensor and Company shall negotiate in good faith the terms of the Licensor Related Technologies License.

License Property

Patent Rights means the U.S. and international patent applications listed below, and any divisional, continuation, or continuation-in-part of such patent applications to the extent the claims are directed to subject matter specifically described therein, as well as any patent issued thereon and any reissue or reexamination of such patent, and any foreign counterparts to such patents and patent applications. shall be periodically amended to include any additional Patent Rights that may arise. 'Patent Rights' shall not include patents or patent applications covering any of the Licensor Related Technologies, to the extent that such technologies would not if owned by a third party infringe any of the claims of the Patent Rights.

United States Provisional Patent Application filed December 3, 2002 serial number 60/430,732 entitled ' Polyvalent, Primary HIV-1 Envelope Glycoprotein DNA Vaccine.
United States Provisional Patent Application filed in September 2003, serial number 60/503/907 entitled 'Polyvalent DNA and Protein Vaccines.'
United States Utility Patent Application filed December 3, 2003 and its foreign counterparts referred to by the parties as the Joint Patent Filing.

Licensed Product means the HIV Vaccine and any product that cannot be developed, manufactured, used, or sold without (a) infringing one or more claims under the Patent Rights, (b) using or incorporating some portion of one or more Biological Materials, or (c) using some portion of the Related
Technology.

Biological Materials means certain tangible biological materials that are necessary for the effective exercise of the Patent Rights, which materials are described, 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 (such as recombinant proteins isolated from a cell extract or supernatant by non-proprietary affinity purification methods). These Biological Materials shall be listed on this agreement, which will be periodically amended to include any additional Biological Materials that Medical School may furnish to Company.

Licensor Related Technologies means any additional technologies outside of the 03-24 Technology and the 03-111 Technology that satisfies all of the following: (i) are now or subsequently owned or licensed to Licensor, including any technologies that may be acquired by Licensor pursuant to its option for an exclusive license of the Medical School Subcontract, (ii) result from work done by Medical School under the Medical School Subcontract for a DNA-based HIV vaccine with protein boost, and (iii) are deemed necessary or advantageous by Company for the development or commercialization of the HIV Vaccine.

The '03-111 Technology – U. S. Patent Application Serial Number 60/503,907 (the '03-111 Patent Filing') covering an HIV protein boost technology invention referred to by Medical School and Licensor as UMMC 03-111.

The '03-24 Technology – UMMC 03-24 entitled Primary and Polyvalent HIV-1 Envelope Glycoprotein DNA Vaccines

Field of Use

Field means therapeutics and prophylactics limited to the generation of DNA-based HIV-1 vaccines.

License Grant

Included with this agreement is the license, sale, lease, distribution, import or use of any Licensee Other Vaccine anywhere in the Developing World and the Developed World.

License Property

Licensee Other Vaccine means any Licensee Vaccine other than a Licensee anti-HIV Vaccine, including, but not limited to, any Licensee Controlled anti-HIV Vaccine and any Licensee Partnered anti-HIV Vaccine.

Field of Use

The field of this agreement is the development of vaccines other than those against HIV for use and distribution in the Developing World.

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.