Royalty Report: Drugs, Biotechnology, Therapeutic – Collection: 4236

License Grant

The Parties wish to jointly own all patents related to Fibroblast Growth Factor and the methods for producing and using FGF, whether such patents are developed jointly or individually by either party; and wish to License from one another exclusive rights to practice under the jointly owned patents in accordance with their respective plans for development and commercialization.

Licensor hereby agrees to assign to the Licensee a 50% ownership interest in the itemized patents and patent applications.

License Property

The Licensee will have a non-revocable, royalty-bearing, exclusive right within the territory to the Patent Rights in the Field, including the right to subLicense to third parties within the Field.

The Licensor will have a non-revocable, royalty free, exclusive right within the territory to the Patent Rights in all other fields outside of the Field, including the right to subLicense to third parties outside of the Field, encompassing any angiogenic or wound healing compositions, (including in particular, but without limitation, all FGF species, fragments, derivatives, and analogs thereof, nucleic acid sequences encoding angiogenic or wound healing proteins/peptides), vectors and host cells comprising said DNA sequences, methods of making the angiogenic or wound healing compositions, and methods of inducing angiogenesis or wound healing employing the said compositions.

1. U.S. 6,268,178 entitled Phage-Dependent Super-Production of Biologically Active Protein and Peptides.
2. U.S. 6,642,026 entitled Method of Producing Biologically Active Human Acidic Fibroblast Growth Factor and its Use in Promoting Angiogenesis.
3. U.S. 6,773,899 entitled Phage-Dependent Super-Production of Biologically Active Protein and Peptides.
4. U.S. 6,794,162, entitled Phage-Dependent Super-Production of Biologically Active Protein and Peptides.
Pending US Patent Applications 1.. U.S. 10/649,480 entitled Method of Producing Biologically Active Human Acidic Fibroblast Growth Factor and its Use in Promoting Angiogenesis; published as US Patent Application No. US 2004/0115769 .

1. International Patent Application No. PCT/US00/40020, published as International Publication No. WO 00/71731 A2 on November 30, 2000 entitled Phage-Dependent Super-Production of Biologically Active Protein and Peptides.
2. International Patent Application No. PCT/US01/25537, published as International Publication No. WO 02/14471 A2 on February 21, 2002 entitled Method of Producing Biologically Active Human Acidic Fibroblast Growth Factor and its Use in Promoting Angiogenesis.
3. International Patent Application No. PCT/US01/25477, published as International Publication No. WO 02/14468 A2 on February 21, 2002, entitled Phage-Dependent Super-Production of Biologically Active Protein and Peptides.

Field of Use

Field shall encompass any angiogenic or wound healing compositions, (including in particular, but without limitation, all FGF species, fragments, derivatives, and analogs thereof, nucleic acid sequences encoding angiogenic or wound healing proteins/peptides), vectors and host cells comprising said DNA sequences, methods of making the angiogenic or wound healing compositions, and methods of inducing angiogenesis or wound healing employing the said compositions.

License Grant

Licensor hereby grants to Licensee a non-revocable, royalty-bearing exclusive right within the Territory to the Patent Rights in the Field, including the right to sublicense to third parties within the Field, provided that any third party sublicensee shall be subject to all of Licensee's obligations.

License Property

The Parties entered into a joint patent ownership and License Agreement dated as of August 16, 2004, which was later amended and restated as of May 23, 2006, for consideration the sufficiency of which was acknowledged in each Agreement, pursuant to which Licensor granted Licensee a 50% ownership interest in certain patents and patents applications listed in the Joint Ownership Agreement, as well as certain future patent rights, and the parties acknowledge that Licensee would have exclusive rights within a defined filed, while Licensor would have exclusive rights outside that field. Licensee and Licensor now wish to enter a new Agreement superseding the Joint Ownership Agreement so as to specify those future patents and patent applications that are to be subject to joint ownership and so as to restate the Licenses granted in the Joint Ownership Agreement. The Parties acknowledge that the jointly owned and cross-Licensed rights are vital to the parties’ respective plans for development and commercialization and wish to further clarify the parties’ respective rights and provide for continued access to the necessary rights in the event of insolvency.

Jointly Owned Patent Applications shall mean the pending Foreign Patent Applications listed below, including any foreign national patent applications which claim priority to the Foreign Patent Applications and any Future Patent Applications, including any continuations, divisionals, re-exams, reissues and continuations-in-part and any other forms of related applications, that claim domestic or international priority to any of the Issued United States or foreign patents, or pending international or foreign patent applications, specifically listed by patent or application number herein.

(a) Issued US Patents:

(i) U.S. 6,268,178 entitled Licensor-Dependent Super-Production of Biologically Active Protein and Peptides; and

(ii) U.S. 6,642,026 entitled Method of Producing Biologically Active Human Acidic Fibroblast Growth Factor and its Use in Promoting Angiogenesis.

(iii) U.S. 6,773,899 entitled Licensor-Dependent Super-Production of Biologically Active Protein and Peptides;

(iv) U.S. 6,794,162, entitled Licensor-Dependent Super-Production of Biologically Active Protein and Peptides;

(b) Foreign Patent Applications

(i) International Patent Applications. All foreign patent applications related to the above-referenced U.S. patents and applications and claiming priority to the following international patent applications under the Patent Cooperation Treaty (PCT):

A. International Patent Application No. PCT/US00/40020, published as International Publication No. WO 00/71731 A2 on November 30, 2000 entitled Licensor-Dependent Super-Production of Biologically Active Protein and Peptides.

Field of Use

The Licensee plans to develop and commercialize therapeutic methods related to the induction of angiogenesis or wound healing by administration of Fibroblast Growth Factor (FGF); and, the Licensor plans to develop and commercialize recombinant DNA methods for producing peptides/proteins.

Field shall encompass any angiogenic or wound healing compositions, (including in particular, but without limitation, all FGF species, fragments, derivatives, and analogs thereof, nucleic acid sequences encoding angiogenic or wound healing proteins/peptides), vectors and host cells comprising said DNA sequences, methods of making the angiogenic or wound healing compositions, and methods of inducing angiogenesis or wound healing employing the said compositions. CARDIO-developed devices and methods of use thereof for delivery of angiogenic or wound healing compositions are not included within the Field, and are not subject to joint ownership or any other terms of this Agreement.

License Grant

The Licensor has granted the Licensee a non-revocable and exclusive worldwide license including the right to sublicense to third parties to the patents necessary to develop and commercialize drug candidates in which Cardio Vascu-Grow is the active ingredient. As a part of that agreement, Licensor will provide technical development services to us for the development and regulatory approvals of our drug candidates, including but not limited to, lab work, testing and production of our drug candidates in which Cardio Vascu-Grow is the active ingredient for clinical trials, all as directed by us.

License Property

We are working closely with an affiliated company, Cardio, pursuant to a joint patent and technology sharing agreement, to manufacture human fibroblast growth factor-1 (Cardio Vascu-Grow) for Cardio’s ongoing clinical trials.

Cardio Vascu-Grow Human Fibroblast Growth Factor-1 treat patients with advanced atherosclerotic disease of their coronary arteries. This treatment, which regenerates new blood vessels in the hearts of these patients.  Atherosclerosis is a disease affecting arterial blood vessels. It is a chronic inflammatory response in the walls of arteries, in large part due to the accumulation of macrophage white blood cells and promoted by low density (especially small particle) lipoproteins (plasma proteins that carry cholesterol and triglycerides) without adequate removal of fats and cholesterol from the macrophages by functional high density lipoproteins (HDL), (see apoA-1 Milano).

Issued US Patents:
1. U.S. 6,268,178 entitled “Phage-Dependent Super-Production of Biologically Active Protein and Peptides;” and
2. U.S. 6,642,026 entitled “Method of Producing Biologically Active Human Acidic Fibroblast Growth Factor and its Use in Promoting Angiogenesis.”
3. U.S. 6,773,899 entitled “Phage-Dependent Super-Production of Biologically Active Protein and Peptides”;
4. U.S. 6,794,162, entitled “Phage-Dependent Super-Production of Biologically Active Protein and Peptides;”
Pending US Patent Applications 1.. U.S. 10/649,480 entitled “Method of Producing Biologically Active Human Acidic Fibroblast Growth Factor and its Use in Promoting Angiogenesis;” published as US Patent Application No. US 2004/0115769

License Grant

The Company entered into an Agreement, which has been superseded by a new exclusive License Agreement dated February 20, 2007, with Korean Company (Licensee) to commercialize its future products. The Company transferred to Licensee the rights to market its products for 99 years in all of the Republic of Korea, China, and Taiwan.

License Property

The Company did this by exclusively licensing its patents to Licensee in Korea, China and Taiwan in the field of: any angiogenic or wound healing compositions and methods of use for which the Company has received marketing approval in the United States, Europe or Japan (including in particular, but without limitation, all FGF species, fragments, derivatives, and analogs thereof), and methods of making the approved angiogenic or wound healing compositions, including any nucleic acid sequences encoding said compositions and any vectors and/or host cells comprising said nucleic acid sequences.

Field of Use

In the field of any angiogenic or wound healing compositions.

License Grant

The University grants to the Company, (i) an exclusive license under the licensed Patents to develop, manufacture, have made, import, use, sell, have sold, distribute, rent or lease Licensed Products/Services throughout the Territory, together with a right to grand sublicenses.

License Property

Certain patent applications titled Nucleic Acids and Proteins of Insect or 83b odorant receptor genes and uses thereof.” The olfaction intellectual property assets are also referred to herein as “our olfaction intellectual property.

License Grant

The Licensor, government public health organization, hereby grants and Licensee accepts, subject to the terms and conditions of this Agreement, a nonexclusive license to Licensee 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 import and have imported, and to offer for sale 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

Cancer Vaccines
Evaluation of Anthrax-Toxoid (AT) delivery system for efficiency in generating immune responses directed against tumor tissues in a mouse model system.
Application of the AT delivery system to two murine tumor models.

DNA Delivery Systems
Evaluation of the AT system for efficiency of DNA expression.
12/1/98
Testing of AT system for generating immune responses for Listeria monocytogenes.
12/1/98
Testing of a human pathogen as a DNA vaccine target.

Persistent Viral Infections
Application of the AT system to the (Latent Cytomegalovirus) LCMV model in mice.
12/1/98
Therapy of immunodeficiency virus (SHIV) infected Rhesus macaques and hepatitis B infected non-human primates using the AT system.

U.S. Patent Number 5,591,631 (USSN 08/021,601), entitled, “Anthrax Toxin Fusion Proteins And Related Methods”, Leppla et al., filed February 12, 1993, issued, January 7, 1997.

U.S. Patent Application Serial Number 08/082,849 (CIP of 08/021,601), entitled, “Anthrax Toxin Fusion Proteins And Related Methods”, Leppla et al., filed June 25, 1993.

Patent Application Serial Number 60/025,270, entitled, “Targeting Antigens To The MHC Class I Processing Pathway With An Anthrax Toxin Fusion Protein”, Klimpel et al., filed September 17, 1996.

Field of Use

Field of Use is for vaccines and immunotherapeutics for the prevention or treatment of human and animal diseases.

License Grant

The UK University hereby grants to the Licensee:
  (a)  an exclusive license in the Territory under the Licensed Technology to conduct research on, develop and commercialize the Licensed Technology, to manufacture, have manufactured, use and have used, market, sell, have sold, offer for sale, have offered for sale, import and export and have imported and exported the compositions, technology or inventions, and to practice (or practise) the processes or methods that are within or that constitute the Licensed Technology for use in the Field.
  (b)  the right to grant Sublicenses (with the right of such sublicensees to grant further sublicenses).

License Property

Licensor owns or has rights in certain technology regarding vectors and the capturing of genes.

Licensed Technology means Improvements, Inventions, Information and Know-How and Patents.
Patents means :
  (a)  (i)  Patent number 5,767,336 granted in the United States of America entitled 'Gene Trap Vectors Comprising a Type II Transmembrane Domain', issued August 4,
  1998;
   (ii) Patent number 5,789,653 granted in the United States of America entitled 'Secretary Gene Trap', issued June 16, 1998;
   (iii)    Patent number 673,650 granted in Australia entitled 'Novel Vectors and Use Thereof for Capturing Target Genes', issued March 4, 1997

Field of Use

Field means the use of *** in *** biology *** relating to genes in the medical industry.

License Grant

Licensor grants an exclusive license for the Licensed Technology in the Field, including, without limitation, the patents and patent applications with the right to grant sublicenses, as well as the right of its sublicensees to grant further sublicenses, to make, have made, use, distribute and sell Licensed Products in the Field using the Licensed Technology covered by the Licensed Patent Rights throughout the Territory.

License Property

PTH technologies useful in the treatment of psoriasis and hair loss.

U.S. Patent No. 5,527,772, 5,840,690, 6,066,618

License Grant

The Company grants Licensee an exclusive, royalty-bearing, non-assignable (without Licensor’s prior written permission), license to Licensor Technology with the right to sublicense under terms of Article XIII herein below in the Territory.

License Property

1. U.S. Patent Application Serial No. 08/236,504 (filed April 29, 1994) — entitled Stem-Loop Cloning Method and Vector
2. U.S. Patent Application Serial No. 08/877,251 (filed June 17, 1997) — entitled Stem-Loop Cloning Method and Vector Notice of Allowance December 28, 1998
3. U.S. Patent Application Serial No. 09/169,793 (filed October 9, 1998) – entitled Stem-Loop Cloning Method and Vector
4. U.S. Patent Application Serial No. 09/397,782 (filed September 16, 1999) — entitled In Vivo Production of ssDNA Using Reverse Transcriptase with Predefined Reaction Termination via Step-Loop Formation
5. U.S. Patent Application Serial No. 09/397,783 (filed September 16, 1999) — entitled  Enzymatic Synthesis of ssDNA
6. U.S. Patent Application Serial No. 09/411,568 (filed October 4, 1999) – entitled In Vivo Production of ssDNA Containing DNA Enzyme Sequence with Rnase Activity
7. International Application No. PCT/US99/23936 (filed October 12, 1999 — entitled Production of ssDNA In Vivo
8. International Application No. PCT/US99/23933 (filed October 12, 1999) – entitled Enzymatic Synthesis of ssDNA

Field of Use

Field of Use used in this Agreement means the employment of uses and/or methods described in any issued U.S. Patents, Patent Applications, Continuations, Continuations in Part or Divisional of which Licensor is inventor, assignee, or licensee as well as to Licensor Technology and Confidential Information for the purpose of producing Pharmacogenomic Substances.