Royalty Report: Drugs, Vaccine, Disease – Collection: 257492

License Grant

Pursuant to the Agreement, Licensee obtained an exclusive license under Licensor patent rights and know-how to develop, make, have made, use and sell Licensed Products in the Territory.

With this amendment the parties wish to amend the Agreement to provide for the reversion of rights to Licensor under the Licensor patent rights and know-how for Influenza vaccine, HPV vaccine and HSV vaccine.

As of the Amendment Effective Date, the license granted to Licensee, and the rights and obligations of Licensee and Licensor arising therefrom, shall no longer apply to Influenza vaccine, HPV Vaccine and HSV Vaccine, and these vaccines shall no longer be deemed to be Licensed Products under the Agreement.

Hereby amended Licensor grants to Licensee an exclusive license, even as to Licensor, under Licensor know-how and patent rights to develop, make, have made, use and sell Licensed products in the Territory with the right to grant sub licenses to Affiliates of Licensee and those persons or entities through whom Licensee, in the normal course of its business collaborates in the manufacture and sale of its products; provided however, that nothing in this Agreement shall prohibit Licensor from utilizing the Licensor know-how and/or patent rights, exclusive of Licensee know-how, to develop, make, have made, use and sell, either by itself or with one or more third parties, products for the treatment of infectious diseases: provided, further, notwithstanding the preceding proviso, that Licensor shall not have any right to develop, make, have made, use, or sell, either by itself or with one or more third parties, Treatment Vaccines.

Licensor grants an option to obtain a license under theLicensor patent rights and know-how to make, have made, use, sell, offer to sell and import Cancer Vaccines in the Territory for up to three (3) Cancer targets. Such Cancer target license shall be exclusive, even as to Licensor, for each Cancer Target so licensed, and shall be sublicenseable by Licensee pursuant to the terms applicable to Licensed Products.

License Property

This amendment includes Amended Definitions Relating to Cancer targets, and, Licensed Product means a bulk or finished AIDS Vaccine, or other vaccine for the prevention of human infectious disease if licensed hereunder, which utilizes the Technology or technology which is developed by Licensor during and as a result of the research collaboration program; and upon the exercise of an Option for a Cancer vaccine, such bulk or finished Cancer vaccine for the prevention of Cancer Indications, provided, however, that if any vaccine is also capable of being used for treatment of the same human infectious disease or Cancer indication, then such therapeutic use of such vaccine shall also be considered a Licensed Product for purposes of the license being granted by Licensor to Licensee under this Agreement; and Treatment vaccines.

Treatment vaccines means a bulk or finished vaccine.

Field of Use

The field of use is for the treatment of Human Immunodeficiency Virus (HIV-1) and/or diseases caused by infection with HIV-1 in humans;  Hepatitis Virus (HBV) and or diseases caused by infection with HBV in humans; and Cancer vaccines for the treatment, but not prevention or prevention and treatment, of Cancer Indications.

License Grant

The original agreement is an exclusive license under Licensor patent rights and know-how to develop, make, have made, use and sell Licensed products in the Territory.

License Property

With this amendment, Licensed products shall also mean Treatment vaccines.  Treatment vaccines shall mean a bulk or finished vaccine.

The parties wish to further amend the Agreement to provide that Merck shall have rights to vaccine products for the treatment of patients infected with Human Immunodeficiency Virus and Hepatitis B Virus.

Field of Use

The field of use is for the treatment of Human Immunodeficiency Virus (HIV-1) and/or diseases caused by infection with HIV-I in humans and Hepatitis B Virus (HBV) and/or diseases caused by infection with HBV in humans, which utilizes the Technology or technology which is developed by Licensor during and as a result of the Research Collaboration Program.

License Grant

For outside the licensed field, Licensor grants a worldwide, non-exclusive, and sublicenseable right and license to practice Licensors rights in Joint Collaboration Patent Rights to make, have made, import, promote, market, distribute or sell Licensee Products outside the Licensed Field.

This agreement contains both exclusive and non-exclusive grants between the parties.

License Property

The Patent Rights and Know-How are pertaining to the PADRE® Technology.

Licensed Product shall mean a therapeutic or prophylactic vaccine the manufacture. use or sale of which, but for any license granted to Licensee herein, would infringe a Valid Claim of one or more Licensor Patent Rights or one or more Collaboration Patent Rights, or was developed or manufactured using Licensor Know-How.

PADRE® Technology shall mean a family of immunostimulatory molecules which when combined with cytotoxic T cell epitopes increase the magnitude and duration of the immune response.

Field of Use

Licensed Field shall mean the research, development and commercialization of Licensed Products for treating or preventing diseases associated with the following viruses: HPV. HBV and HCV.  HBV shall mean Hepatitis B Virus.  HCV shall mean Hepatitis C Virus.  HPV shall mean Human Papilloma Virus.  First HPV Indication shall mean treatment or prevention of cervical dysplasias and neoplasia.

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

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

License Property

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

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

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

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

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

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

Field of Use

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

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

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

License Grant

The 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

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

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

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

Foundation grants to Licensee the exclusive right and license to make, have made, use, import, offer for sale, and sell in the Territory, Licensed Products during the term of this Agreement including Licensee’s right to grant sublicenses.

The license granted is subject to a reserved, non-exclusive license of Foundation, transferable to University and its not-for-profit academic collaborators, to practice the Licensed Patents in the Field, only for the purpose of non-commercial scientific inquiry, academic research, and education.

License Property

Licensed Product means any compound, product, service, or process in the Field, the manufacture, use, or sale of which, but for the license granted herein, would infringe at least one Valid Claim.

Licensed Patents means (i) the patent applications listed, (ii) the United States patents that may issue from the patent applications listed and from divisionals and continuations and continuations-in-part of such United States patents and patent applications, (iii) all foreign counterparts of such patent applications, and all patents that issue thereon anywhere in the world, including reexamined and reissued patents. Licensed Patents shall also mean any patent application having claims in the Field directed to an invention made in the laboratory of Dr. Vasu Nair six months or less prior to the Effective date, and (iv) with respect to the matters described in clauses (i), (ii) and (iii) above, all provisionals, renewals, re-examinations, patents of addition, supplementary protection certificates, extensions, restorations of patent terms, letters of patent, registration or confirmation patents and reissues of such patents or patent applications.
7,250,421 – Diketo acids with nucleobase scaffolds: anti-HIV replication inhibitors targeted at HIV integrase

Indication shall mean the prevention, treatment or diagnosis of a condition, infection or disease caused by or associated with a specific virus in the Field. For example HIV Indication means the prevention, treatment or diagnosis of a condition, infection or disease caused by or associated with Human Immunodeficiency Virus (HIV) and HCV Indication means prevention, treatment or diagnosis of a condition, infection or a disease caused by or associated with Hepatitis C Virus (HCV).

Field of Use

Field means any and all anti-viral uses, including but not limited to prophylaxis, diagnosis or treatment of a condition, infection or disease associated with a virus, except the Field specifically excludes any anti-viral use associated with (a) the following DNA virus families:  poxviridae, polyomaviridae, papillomaviridae, adenoviridae, and parvoviridae; and (b) all RNA viruses except for the following RNA virus families, which are specifically included in the Field:  retroviridiae (for example HIV as defined below), flaviviridae (for example HCV as defined below), orthomyxoviridae, paramyxoviridae, and coronaviridae. In the event that Licensee terminates the Sponsored Research Agreement (“SRA”), a copy of which is attached as Appendix J, pursuant to paragraph 16(d) of the SRA, the Field of this License Agreement shall automatically be amended to exclude HCV.

License Grant

Licensor grants a worldwide, exclusive, and sublicensable right and license to practice the Licensor Technology and all of Licensors rights in Collaboration Patent Rights to make. have made. use. import, promote, market,  or sell Licensed Products in the Licensed Field.

Licensor grants a worldwide, exclusive or non-exclusive, as the case may be, and sublicenseable  right and license to practice the Third Party Technology to make, have made, use, import, promote, market, distribute or sell Licensed Products in the Licensed Field.

For the Grant of License to Joint Collaboration Patent Rights Outside the Licensed Field, Licensor grants a worldwide, non-exclusive, and sublicenseable right and license to practice Licensors rights in Joint Collaboration Patent Rights to make, have made, import, promote, market, distribute or sell products or processes outside the Licensed Field.

License Property

The Patent Rights and Know-How are pertaining to the PADRE® Technology.

Licensed Product shall mean a therapeutic or prophylactic vaccine the manufacture. use or sale of which, but for any license granted to Licensee herein, would infringe a Valid Claim of one or more Licensor Patent Rights or one or more Collaboration Patent Rights, or was developed or manufactured using Licensor Know-How.

PADRE® Technology shall mean a family of immunostimulatory molecules which when combined with cytotoxic T cell epitopes increase the magnitude and duration of the immune response.

Field of Use

Licensed Field shall mean the research, development and commercialization of Licensed Products for treating or preventing diseases associated with the following viruses: HPV. HBV and HCV.  HBV shall mean Hepatitis B Virus.  HCV shall mean Hepatitis C Virus.  HPV shall mean Human Papilloma Virus.   First HPV Indication shall mean treatment or prevention of cervical dysplasias and neoplasia.

License Grant

Pursuant to the License Agreement, the company has been granted the following: (i) an exclusive worldwide license to use, deal in, test, promote, market, distribute and sell the Product; (ii) the right to sublicense such exclusive license; and (iii) the right to use certain technology, patent rights and other confidential information disclosed by one of the original parties or its subsidiary (Israel)  (a) solely for the purpose of manufacturing the Product at one facility in each of Israel, India and the People’s Republic of China, or such other country, provided that the requisite approval from the Israeli Office of the Chief Scientist is obtained, (b) to use, sell, offer to sell and import the Product manufactured by the company in accordance with the License Agreement and (c) sublicense any rights granted to company under the License Agreement.

License Property

The License Agreement applies to the sales of Sci-B-Vac, a third generation HBV vaccine for adults, children and newborns, which is registered in twelve countries throughout the world. Sci-B-Vac™, has not yet been approved by the FDA or the EMA. In Israel, where more than 500,000 persons have already been vaccinated with our vaccine, Sci-B-Vac™, is considered the standard of care. We have sold more than 1.5 million units in Israel. Certain clinical trials have shown the advantage of Sci-B-Vac™ over GlaxoSmithKline’s Engerix-B®, one of the primary existing HBV vaccines available for the hepatitis B virus, in preventing hepatitis B infection. We are currently developing a clinical program to support the approval from the FDA and from the EMA to market Sci-B-Vac™ for sale for vaccination of pre-dialysis and HIV patients in the United States and the EU, respectively.

Field of Use

This agreement pertains to vaccine products to prevent and treat infectious and immune diseases in the medical industry relating to drugs.

License Grant

This is an exclusive License to use a proprietary cell line to develop and potentially commercialize recombinant human papillomavirus (HPV) virus-like particle (VLP) vaccines.

Pursuant to the License Agreement, Licensee has an exclusive worldwide License to develop, manufacture and market HPV-16 VLP vaccines for the prevention and/or treatment of HPV infection, except that Licensor retained the right to co-market the product in the United States, including Puerto Rico.

Field of Use

The parties are currently working together on manufacturing HPV-16 VLP vaccines being evaluated by the National Cancer Institute in clinical trials. The vaccines are designed to prevent and/or treat HPV-16 infection and associated cervical cancer.

License Grant

The Agreement is to clarify and include additional rights for the use of QS-21 Stimulon.  In addition, the company granted the Licensee the first right to negotiate for the purchase of the Company or certain of our assets. The first right to negotiate will expire after five years.

License Property

QS-21 Stimulon, an investigational adjuvant used in numerous vaccines under development for a variety of diseases including, but not limited to, hepatitis, HIV, influenza, cancer, Alzheimer’s disease, malaria, and tuberculosis.

Field of Use

This agreement pertains to the drug industry relating to but not limited to, hepatitis, HIV, influenza, cancer, Alzheimer’s disease, malaria, and tuberculosis.

License Grant

The company executed a worldwide exclusive license agreement with the the University for ThermoVax®, which is the subject of U.S. patent number 8,444,991 issued on May 21, 2013 titled “Method of Preparing an Immunologically-Active Adjuvant-Bound Dried Vaccine Composition.”

License Property

This patent and its corresponding foreign filings are licensed to us by the University and they address the use of adjuvants in conjunction with vaccines that are formulated to resist thermal inactivation. U.S. Patent 8,444,991 is expected to expire in December 2031. The license agreement also covers thermostable vaccines for biodefense as well as other potential vaccine indications.

Field of Use

This agreement pertains to the drug industry relating to vaccines.

The company is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need.  The Company maintains two active business segments: BioTherapeutics and Vaccines/BioDefense.

The Company’s BioTherapeutics business segment is developing a first-in-class photodynamic therapy (SGX301) utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (“CTCL”), proprietary formulations of oral beclomethasone 17, 21-dipropionate (“BDP”) for the prevention/treatment of gastrointestinal (“GI”) disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201), and it’s novel innate defense regulator (“IDR”) technology dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer.

The Company’s Vaccines/BioDefense business segment includes active development programs for RiVax™, its ricin toxin vaccine candidate, VeloThrax™, an anthrax vaccine candidate, OrbeShield®, a GI acute radiation syndrome (“GI ARS”) therapeutic candidate and SGX943, a melioidosis therapeutic candidate. The development of the vaccine programs currently supported by the heat stabilization technology, known as ThermoVax®, under existing and on-going government contract funding. With the government contract from the National Institute of Allergy and Infectious Diseases (“NIAID”), the Company will attempt to advance the development of RiVax™ to protect against exposure to ricin toxin. The Company plans to use the funds received under the government contracts with the Biomedical Advanced Research and Development Authority (“BARDA”) and NIAID to advance the development of OrbeShield® for the treatment of GI ARS.

License Grant

Licensor Technology.  Licensor hereby grants to Licensee and Licensee hereby accepts a worldwide, non-exclusive license in the Fields and in the Territory under the Licensor Technology, with a right to sublicense, to (a) make, have made, use, export and import CpG 7909, and sell CpG 7909 to a Licensee Affiliate or Related Party and (b) make, have made, use, offer to sell, sell, export and import Product(s).

Non-Exclusive License Grant. In the event that the making, having made, use, offer for sale, sale, export or import by Licensee, or Licensee’s Related Parties, of CpG 7909 or Product(s) would infringe, during the term of this Agreement, a claim of issued letters patent which Licensor owns or has the rights to license and which patents are not covered by the grant, Licensor hereby grants to Licensee a non-exclusive, sublicensable, royalty-free license in the Territory under such issued letters patent for Licensee and its Related Parties to make, have made, use, sell, offer for sale, export and/or import CpG 7909 and Product(s) in the Field and in the Territory.

Grant-back License.  Licensee will grant to Licensor a non-exclusive, royalty-free, fully-paid up, perpetual worldwide license, including the right to grant sublicenses, to any Licensee Patent arising under the Agreement, which claims recite the use, formulation or any other Improvements solely related to the licensed Licensor Technology (each a “LicensorTechnology Improvement”) to the extent necessary for Licensor and its sublicensees to practice Licensor Technology Improvements outside the Fields.

License Property

Product means any Vaccine which contains CpG 7909 co-formulated with one or more Antigen using the Delivery Method for any and all uses in a Field, whether such Product is for sale by prescription, over-the-counter or by any other method or for use in a Clinical Trial. Product includes any Vaccine which contains CpG 7909 that is being Developed under this Agreement for Marketing Authorization as well as Additional Products for which the Option hereunder has been exercised. For purposes of clarity, no Product may be Developed for the prevention, treatment or control of any cancer nor may any Clinical Trial be conducted with a Product with clinical endpoints of prevention, treatment or control of any cancer.

CpG 7909 means the Adjuvant Controlled by Licensor that is a proprietary immunomodulatory oligonucleotide containing unmethylated cytosine and guanine dinucleotides whose sequence has been defined by Licensor as CpG 7909 which acts as an agonist of toll-like receptor 9 to modulate the immune response.

Additional Product means any Vaccine which contains CpG 7909 co-formulated with one or more Antigen using the Delivery Method for any and all uses in an Additional Field for which Licensee has exercised its Option under this Agreement.

Licensor Technology means any and all Licensor Know-How and Licensor Patent Rights.

Licensor Patent Right(s) means all Patent Rights Controlled by Licensor as of the Effective Date, including those listed, or Controlled by Licensor during the Term of this Agreement, which claim or cover CpG 7909 or the use, formulation or Manufacture of CpG 7909 or Products in the Territory.

US 6,194,388 – Immunomodulatory oligonucleotides
US 6,429,199 – Immunostimulatory nucleic acid molecules for activating dendritic cells
US 7,001,790 – Light-emitting aluminum gallium indium nitride compound semiconductor device having an improved luminous intensity

License Patents means any and all issued patents in the Territory which during the Term of this Agreement are Controlled by Licensee or its Controlled Affiliates, which (a) claim or cover Product or (b) which claim or cover a use, formulation or method of manufacture solely related to the licensed Licensor Technology.

Field of Use

Fields means all uses in humans of Vaccines that is indicated and/or used for the following Indications (each of which constitutes a Field):
a. Prevention of Infection with Hepatitis B Virus
b. Prevention of Infection with Seasonal Interpandemic Influenza Virus
c. Prevention of Infection with Pandemic Influenza Virus
d. Treatment of Alzheimers Disease
Field also includes any Additional Field for which Licensee has exercised the Option under.

License Grant

The Swiss Licensor grants a non-exclusive license under the adr-HBsAg Technology, with the right to sublicense, to research, develop, manufacture, have manufactured, market, distribute, import, use, offer for sale and sell Vaccines in the Territories for use solely in the Disease Field. Such license grant does not permit the transfer by Licensee to any third party of adr-HBsAg other than as part of assembled
Vaccines, including, without limitation, transfer of Vaccines to third parties for preclinical testing, toxicology, or clinical trials, without the prior written approval of Berna, such approval not to be unreasonably withheld.  The license granted is specific to the Disease Field.

Licensor grants the right to sublicense the right to research, develop, manufacture, have manufactured, market, distribute, import, use, offer for sale and sell Vaccines in the Territories under the adr-HBsAg Technology in the Disease Field.

License Property

adr-HBsAg shall mean the hepatitis B surface antigen of the subtype adr produced with the Hansenula polymorpha Expression System.

Therapeutic Vaccine shall mean a therapeutic hepatitis B vaccine developed by Licensee or its sublicensee and comprised of an ISS and adr-HBsAg, and that potentially utilises additional delivery or adjuvant technology, in pharmaceutical dosage forms suitable for human use.

Prophylactic Vaccine shall mean a prophylactic Hepatitis B vaccine developed by Licensee or its sublicensee and comprised of an ISS and adr-HBsAg, and that potentially utilizes additional delivery or adjuvant technology, in pharmaceutical dosage forms suitable for human use.

Field of Use

Disease Field shall mean the field of inducing an active, long term prophylactic response or therapeutic immune response against Hepatitis B, including chronic status, in humans.

License Grant

For the Licensed Intellectual Property, Licensor grants the exclusive, even as to Licensor, a worldwide, nontransferable right and license, with the right to grant sublicenses, under the Licensed Intellectual Property, to use, have used, sell, have sold, offer to sell, import, have imported, make and have made, and otherwise research, Develop, Commercialize or manufacture any Licensed Vaccine and/or Licensed Product, during the Term, in the Territory in the Field.

For the Trademarks for Licensed Products. To the extent that Licensor owns any Trademark(s) that pertain specifically to a Licensed Vaccine or Licensed Product, Licensor grants an exclusive right and license, with the right to grant sublicenses to Trademark(s) Controlled by Licensor solely for use with respect to such Licensed Vaccine or Licensed Product, as the case may be.

License Property

Licensor has expertise in drug discovery, development, and manufacturing of yeast-based immunotherapeutics known as Tarmogen® products.

Licensor has rights under certain patent rights and know-how rights relating to Tarmogens.

Licensed Product means any product in final form that contains a Licensed Vaccine as a therapeutically or prophylactically active ingredient.

Combination Product means any product sold in a particular country that contains a Licensed Vaccine in combination with one (1) or more other therapeutically active ingredients or drug delivery technology, devices, equipment or other components, as applicable, or formulated or packaged separately but sold together for a single price.

Field of Use

The collaboration is for the prevention and/or treatment of hepatitis B virus infection and its sequelae.

The Field means, any and all human diseases and conditions, except the treatment of any malignancy; provided, however, that Field shall include [the treatment, palliation, diagnosis and/or prevention of hepatitis that may result in the prevention and/or reduction in frequency and incidence of any and all sequelae of hepatitis infection, including the prevention and/or reduction in the frequency and incidence of hepatocellular carcinoma in patients who have co-existing hepatocellular carcinoma.

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

The parties have agreed to enter an agreement for the Licensor of the United Kingdom to manufacture and supply products in the field of live or dead wild type attenuated or recombinant Listeria based vaccines to Licensee to undertake clinical trials and commercial sales in respect of such vaccines.

If Licensor is unwilling, or unable to supply and manufacture either Clinical Product or Bulk Product under the terms herein, Licensor will transfer the necessary Vaccine Process to enable a third party to manufacture and supply any part of the Clinical Product and/or Bulk Product to Licensee.

The parties have agreed that Licensor will have the right of first refusal to manufacture and supply Clinical Product and Bulk Product for use in the program of research and development, clinical trials and commercial exploitation.

License Property

Bulk Product means any and all Bulk Drug Substance, Drug Product and/or Programme Deliverable supplied by Licensor to Licensee under this Agreement for commercial use.

Clinical Product means the Programme Deliverable which is to be used in the development phase of the Programme and/or the Clinical Trials.

Vaccine Process means the process, methods, synthesis for making, using or exploiting the Drug Substance to produce the Drug Product for inclusion within the Programme Deliverable; .

Field of Use

The field of use is the field of live or dead cell based wild type or attenuated or recombinant Listeria vaccines with a therapeutic and/or preventative effect, for use in cancer and other indications.