Royalty Report: Drugs, Biotechnology, Wound Care – Collection: 28032

License Grant

Board hereby grants and agrees to grant to Licensee a royalty-bearing, exclusive license under Licensed Subject Matter to manufacture, have manufactured, sell, offer for Sale, import and use Licensed Product and Licensed Process within the Licensed Territory within the Licensed Field; provided, however.

License Property

TP508 Technology shall mean (i) any and all subject matter claimed in Patent Rights; and (ii) peptides which bind to and/or stimulate a thrombin receptor, compositions which contain such peptides, methods of producing such peptides, detecting such peptides, and utilizing such peptides diagnostically and/or therapeutically, including, but not limited to, thrombin derived polypeptides, agonists or antagonists of the proteolytically or non-proteolytically activated thrombin receptor or receptors or agonists and antagonists of other cellular effects activated by proteolytic or non-proteolytic thrombin interactions and which are made or developed by Carney or any University employee working under the supervision or direction of Carney.

TP508 is a 23-amino acid synthetic peptide representing a receptor-binding domain of the human thrombin molecule, a naturally occurring molecule in the body responsible for both blood clotting and initiating many of the cellular events responsible for tissue repair in bone and cartilage.  A single topical application of TP508 stimulates revascularization and healing of acute incisional and excisional wounds in normal, healthy rat skin.

Field of Use

Licensed Field shall mean all fields of use.

License Grant

Licensor hereby grants to Licensee a series of options to acquire exclusive United States and worldwide licenses, as set forth below, to make or have made, use, sell and sublicense Licensed Products under the Technology Rights for Orthopaedic Applications of the type described. Each such license shall run for the lives of all Patents and other patents owned by or licensed to Licensor, and related to any Licensed Product, which are appropriate for the territory licensed.

License Property

Licensed Products means devices or materials including but not limited to TP508 and related peptides, all products using any of such materials, Licensor Technology or any of the Technology Rights, and all other products which, in the course of their manufacture, use, or sale would, in the absence of this license, infringe one or more claims of any of the Patent Rights which have not been finally adjudicated to be invalid by a court of competent jurisdiction.

Licensor Technology means the core technologies related to the Patents, including the TP508 Peptide.

Licensor Product means TP508 or any related peptides, or any other materials or products manufactured by or for Licensor and sold to Licensee for research, treatment of patients or resale.

Patents means U.S. patents Number 5,352,664 and 5,500,412, all related foreign patents, including patents issued in Europe, Canada and Japan, and any divisional, continuation, and continuation-in-part applications and patents based thereon, any reissues or extensions thereof, and any corresponding or additional United States and foreign patent applications.

Field of Use

This agreement pertains to the medical industry relating to Orthopaedic Applications that shall include, and be limited to, the use of the Technology  Rights in connection with: Treatment of fractures, osteoarthritis or osteoporosis, treatment of damage to meniscus, ligament, cartilage or tendon, preparation or application of segmental bone filling, coating or preparation of bone or joint implants, and spinal fusion (bone related).

License Grant

The University grants the Licensee an exclusive right and license to practice, commercialize and otherwise exploit the Licensed Patents and grants the exclusive right and license to make, have made, research, develop, use, lease, offer to sell, sell, import and export Licensed Products, within the Licensed Field of Use in the Licensed Territory during the term.
The Licensee has the right to grant sublicenses.

License Property

The licensee covers AEM-28 and certain analogs.

U.S. Patent No. 6,156,727. Anti-atherosclerotic peptides and a transgenic mouse model of atherosclerosis.
U.S. Patent No 6,506,880. Synthetic peptides that enhance atherogenic lipoprotein uptake and lower plasma cholesterol.
U.S. Patent No. 7,653,771. Synthetic single domain polypeptides mimicking apolipoprotien F, Anantharamaiah.

Apolipoprotein E (Apo E) is a 299 amino acid protein that plays an important role in lipoprotein metabolism. AEM-28 is a 28 amino acid mimetic of Apo E that contains a domain that anchors into a lipoprotein surface while also providing the Apo E binding domain that is removed by heparin sulfate receptors in the liver. AEM-28 as an Apo E mimetic has the potential to restore the ability of atherogenic lipoproteins to be cleared from the plasma, completing the reverse cholesterol transport pathway, and thereby reducing cardiovascular risk. This is an important mechanism of action for AEM-28. For patients that lack LDL receptors (Homozygous Familial Hypercholesterolemia or HoFH), have Severe Refractory Hypercholesterolemia, or have acute coronary syndrome, AEM-28 may provide a therapeutic solution.

Field of Use

Licensed Field of Use means any and all diagnostic, therapeutic and prophylactic uses in all fields of use, and for all indications except diseases of the eye.

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.