Royalty Report: Medical, Supply, Wound Care – Collection: 5290

License Grant

The Licensee entered into a five-year license agreement with Licensor relative to a technology known as OPLA. The Licensee and Licensor are committed to research and development of specified uses of the OPLA technology.

License Property

The Open-cell Polylactic Acid or OPLA is a porous polymer foam technology, and to our biomaterials technology platform in the orthopedics drug and delivery markets.  This porous tissue matrix technology facilitates wound healing in both bone and soft tissue and is bio absorbable at controlled rates for specific functions and tissues.  This technology adds a series of products, development programs and intellectual property related to porous biodegradable regeneration matrices.  Specifically, we are researching applications for articular cartilage regeneration, bone growth scaffolds for spinal and trauma applications and for the delivery of drugs and growth factors.

License Grant

The agreement licensed certain bone wax rights to develop products in the field of bone remodeling, based on patent number 7,074,425 for use in the human skeletal system.  The license agreement excludes the fields of (1) a resorbable hemostat (resorbable bone wax), (2) a resorbable orthopedic hemostat (bone wax) and antimicrobial dressing, and (3) veterinary orthopedic applications. In January 2014, Licensee received 510k approval for their first product under the license, a bioactive bone graft putty and bone graft extender.  In February 2014, Licensor granted a Commercial License to Licensee according to the terms of the development and license agreement.

License Property

The Licensor acquired patent 7,074,425 in September 2009.  It is for a resorbable bone wax and delivery system for orthopedic bone void fillers. The patent offers innovative, safe and effective resorbable orthopedic products that are complementary to the already existing Licensor products.  The bone wax and delivery system address issues such as bone wax granuloma and the cost-effective delivery of materials that manage bone wound healing. The resorbable orthopedic products covered by the patent are (a) a resorbable orthopedic hemostat (resorbable bone wax) used to stop blood flow, (b) a delivery system for osteogenic/osteoinductive orthopedic products (bone void fillers), and (c) the formula as a delivery system for bone growth factors.

License Grant

Licensor of Netherland hereby grants to Licensee of Netherland an exclusive license for the under Patents and Technology to make, have made, use, import, sell, offer to sell or have sold on its behalf product, including the right to sublicense third parties.

License Property

The Company has exclusively licensed its PolyActive polymer biomaterial technology and patents to Matrix; non-allograft bone tissue.

Tissue Adhesion (Barrier); Method for preventing tissue adhesion 08/279,811 5,480,436 525400-99 USA
Tissue Adhesion (Barrier); Method for preventing tissue adhesion 08/078,350 5,508,306 525400-84 USA
Artificial Skin 574654 5,147,401 525400-151 USA
Substrate for treating skin defect (Second PolyActive artificial skin) 08/298,411 Pending 525400-112 USA
Prosthetic Devices formed from materials having bone-bonding properties and uses 08/389,303 Pending 525400-126 USA therefor. Devices of method?
Prosthetic Devices formed from materials having bone-bonding properties and uses 08/089,857 Pending 525400-68 USA therefor. Devices of method?
Polyester ester copolymers as drug delivery matrices 08/699,896 Pending 525400-157 USA

License Grant

LICENSOR hereby grants to LICENSEE, to the extent of the LICENSED FIELD and LICENSED TERRITORY, a license under PATENTS, to fully practice PATENTS, including the right to make, use, offer for sale, sell and import PRODUCTS and promote the methods and compositions recited in the claims of PATENTS using PRODUCTS in the LICENSED FIELD.

License Property

The U.S. and foreign issued patents relates to platelet-based growth factors (used in platelet rich plasma gel used in wound care in the specific field of use covering diagnostic and therapeutic spinal, neurosurgery and orthopedic surgery. U.S. Patent No. 5,165,938 entitled “Wound Healing Agents,” issued 11/24/92.

Field of Use

SCHEDULE OF PRODUCTS
SEPARATORS
2760-40-101       Disposable Processing Kit – Single
2760-40-102       Disposable Processing Kit – Double

Disposable Processing Kits contain the items required for containing blood during processing in the centrifuge

CAPITAL
2760-40-000       Centrifuge
2760-40-310       Centrifuge and Cart Assembly

APPLICATORS/ MIXERS
2760-40-200       Applicator Kit

License Grant

University hereby grants to Licensee and Licensee accepts, subject to the terms and conditions hereof, in the territory and in the field an exclusive commercial license under University patent rights, to make and have made, to use and have used, to sell and have sold the licensed products, and to practice the licensed processes, for the life of the university patent rights. Such licenses shall include the right to grant sublicenses.

License Property

University Patent Rights: Universitys ownership interest in the United States patents listed below to the License Agreement, including all divisional,  continuations, continuations-in-part, extensions and renewals, and the inventions described and claimed therein.

Universitys rights in the United States Patents listed below, and the inventions described and claimed therein:
U.S.P.N. 5,019,559 – Wound healing using PDGF and IGF-II
U.S.P.N. 4,861,757 – Wound healing and bone regeneration using PDGF and IGF-I
U .S.P.N. 5,124,316 – Method for periodontal regeneration
U.S.P.N. 4,874,746 – Wound healing composition of TGF-alpha and PDGF
U .S.P .N. 4,983,581 – Wound healing composition of IGF-I and TGF-.beta.
U.S.P.N. 5,256,644 – Wound healing using IGF-II and TGF
U.S.P,N. 5,034,375 – Process of wound healing using PDGF and EGF
U.S.P.N. 5,035,887 – Wound healing composition of IL-1 and PDGF or IGF-1
U.S.P.N. 5,516,699 – Pyridinoline crosslinks as markers of periodontal and peri-implant disease activity

Licensed Products: products covered by University Patent Rights or products made or services provided in accordance with or by means of licensed processes.

Territory: All countries in which University has granted Licensee a license under University Patent Rights.

rhPDGF is a bio-active protein that is a key mediator of wound healing and tissue regeneration.

Field of Use

rhPDGF is a key stimulator of the body's natural wound healing process. It has a well-established mechanism of action that leads to stimulation of certain cell types, including those important to bone, cartilage, tendon and ligament healing.

License Grant

We signed an exclusive license and supply agreement with Licensor for its poly-4-hydroxybutyrate polymer for certain fields of use, which we have branded Biofiber.

License Property

Biofiber is a high-strength biodegradable polymer that we have used in suture applications and in several soft tissue repair development projects.  Biofiber is an advanced high-strength resorbable polymer fiber produced using recombinant DNA technology as well as our F2A peptide, a synthetic version of the natural human FGF-2 growth factor.

Field of Use

The Licensee is global medical device company focused on surgeons that treat musculoskeletal injuries and disorders of the shoulder, elbow, wrist, hand, ankle and foot.  The Field of Use apply to an extremity specialist customer base a broad line of joint replacement, trauma, sports medicine and orthobiologic products to treat extremity joints

License Grant

The Licensor hereby grants to the Swiss Licensee the exclusive right and License in the Field under Licensor's Intellectual Property Rights to market, offer for sale, sell, distribute including sublicensing, and import products, including the Product, in the territory, the exclusive right and License in the Field under Licensor's Intellectual Property Rights to use the Product in the territory, provided that such right and License is limited to such use as is necessary for Licensee to market, offer for sale, sell, import, Manufacture the Product in the territory, and a non-exclusive right and License to use the Product and all information and Intellectual Property Rights with respect thereto (including, without limitation, data, studies and clinical trials) solely for the purpose of obtaining Regulatory Approvals for the Product.

License Property

The Licensor has developed a proprietary wound dressing and has obtained United States Patent Nos. 7,351,430 and 7,910,135 in connection with the Product.

Product means Licensor medical device, in bulk or in finished form.

Product
Means Altrazeal® medical device, in bulk or in finished form.
All applications of Altrazeal® and the NanoFlex®

Technology in wound care including:
– Altrazeal® Base Product
– Altrazeal® Silver
– Altrazeal® Collagen
But excluding:
– Altrazeal® containing pharmaceutical actives subject to the drug approval process
– Altrazeal® containing Biologics

Field of Use

Field means the human advanced wound management to include the treatment and control of both chronic and acute soft tissue injury.

License Grant

The Licensor grants the Licensee an exclusive License to market the Product and an exclusive right to purchase from the Licensor and distribute the Product.

License Property

The Licensor has developed a proprietary wound dressing and has obtained United States Patent Nos. 7,351,430 and 7,910,135 in connection with the Product.

Patents shall mean United States Patent Nos. 7,351,430 and 7,910,135 in connection with the Product European Patent Application Nos. WO 2004/043438A1 and WO 2008/070270A2.; Australia Patent No. 10/289,756 and New Zealand Patent No. NZ540571(A).

Product means Altrazeal® medical device, in bulk or in finished form. All applications of Altrazeal® and the NanoFlex®

Technology in wound care including:
Altrazeal® Base Product
Altrazeal® Silver
Altrazeal® Collagen

But excluding:
Altrazeal® containing pharmaceutical actives subject to the drug approval process
Altrazeal® containing Biologics

ALTRAZEAL Transforming Powder Dressing is a revolutionary wound treatment technology that utilizes proprietary nanoflexâ„¢ technology to promote the healing of exuding wounds. ALTRAZEAL powder particles are the result of a rigorous development program where the product has been engineered to provide the necessary wound-healing benefits. ALTRAZEAL is designed to provide optimal oxygen and vapour transpiration, as well as microbial impermeability, tensile strength, and flexibility.

ALTRAZEAL consists of a sterile white powder in a single-use, sterile foil laminate pouch or transparent blister.

ALTRAZEAL is applied to an exuding wound by sprinkling the powder on to the open wound. The particles then hydrate and aggregate to a final moisture content of approximately 68% by mass. The aggregated powder becomes a moist, flexible dressing over the surface of the open wound that provides an ideal moist wound environment supporting cellular function and tissue repair.

Field of Use

Field means the human advanced wound management to include the treatment and control of both chronic and acute soft tissue injury.

License Grant

A U.S. pharma has granted the worldwide rights to a U.S business unit of an Italian company the Knighton patent for all applications relating to the use of autologous platelet releasate therapies for healing purposes (wound-healing and tissue repair therapies).  U.S. Patent No. 5,165,938 entitled Wound Healing Agents.

License Property

5,165,938: A process for treating a wound of a live animal which comprises applying over the wound an effective amount of a treating composition containing the materials released by platelets during the platelet release reaction and facilitating healing of the wound.

Field of Use

Licensed Fields means any and all fields of use.

License Grant

Licensor grants the worldwide right and exclusive license, with the right to grant sublicenses, under the Patent Rights to make, have made, use, lease, sell, offer for sale and import for use or resale the Licensed Products, and to practice the Licensed Processes, in the Territory for the Field.

Licensor also grants a non-exclusive license to Know-how, and a non-exclusive license to use Biological Materials in connection with licensees research and development of Licensed Products.

License Property

The patents include Reconstruction of Urological Structures with Polymeric Matrices;  Achievement of Excretory Renal Function Using a Neo-Morphogenic System In Vivo; Penile Reconstruction; Ex vivo Engineered Stents for Urethral Structures; Creation of Tissue Engineered Female Productive Organs (Vagina); Augmentation of Organ Function;  and, Tissue Engineered Uterus and Fallopian Tubes.

Biological Materials shall mean the specific proprietary biological materials, including Progeny and Unmodified Derivatives of those materials.  Progeny shall mean an unmodified descendant from the material, such as a virus from virus, cell from a cell, or organism from an organism; Unmodified Derivatives shall mean substances created by the Licensee which constitute an unmodified functional subunit or product expressed by the original material, such as subclones of unmodified cell lines, purified or fractionated subsets of the original material, proteins expressed by DNA/RNA, or monoclonal antibodies secreted by a hybridoma cell line; and Modifications shall mean substances created by the Licensee which contain or incorporate the material.

Field of Use

Field of Use shall mean the development and commercialization of tissue engineered products for human and animal therapeutics in the subfields of genitourinary, vascular tissue, nervous tissue, trachea and other subfields when and if mutually agreed upon by the parties in writing.

License Grant

The Company hereby grants a worldwide, non-exclusive, non-transferable, non-assignable, non-sublicensable  terminable license under the Intellectual Property that is the subject of Medtronic’s infringement, to make, have made, use, import, distribute, sell, have sold the Licensed Products incorporating or utilizing such Subject Technology within the Medtronic Area of Interest.

License Property

Medtronic Area of Interest means the areas of cardiovascular (excluding the tissue-engineered vascular grafts), endocrine, neurological, and spinal conditions or diseases.

A. ISSUED U.S. PATENTS
4,721,096   Process for Replicating Bone Marrow In Vitro and Using the Same
4,960,489   Three-Dimensional Cell and Tissue Culture System
5,032,508   Three-Dimensional Cell and Tissue Culture System
5,160,490   Three-Dimensional Cell and Tissue Culture System Apparatus
5,266,480   Three-Dimensional Skin Culture System
5,443,950   Three-Dimensional Cell and Tissue Culture System
5,460,939   Temporary Living Skin Replacement
5,478,739   Three-Dimensional Stromal Cell and Tissue Culture System
5,510,254   Three-Dimensional Cell and Tissue Culture System
5,512,475   Three-Dimensional Skin Cell and Tissue Culture System
5,516,680   Three-Dimensional Kidney Cell and Tissue Culture System
5,516,681   Three-Dimensional Pancreatic Cell and Tissue Culture System
5,518,915   Three-Dimensional Mucosal Cell and Tissue Culture System
5,541,107   Three-Dimensional Bone Marrow Cell and Tissue Culture System
5,559,022   Liver Reserve Cells
5,578,485   Three-Dimensional Blood-Brain Cell and Tissue Culture System
5,580,781   Three-Dimensional Tumor Cell and Tissue Culture System
5,599,788   Method for Accelerating Skin Wound Healing with H3 Protein
5,624,840   Three-Dimensional Liver Cell and Tissue Culture System
5,714,588   Enhancement of Cellular Attachment Using H3 Protein
5,763,267   Apparatus for the Large Scale Growth and Packaging of Cell
            Suspensions and Three-Dimensional Tissue Cultures
5,785,964   Three-Dimensional Genetically Engineered Cell and Tissue Culture
            System
5,792,603   Apparatus and Method for Sterilizing, Seeding, Culturing, Storing,
            Shipping and Testing Tissue, Synthetic or Native, Vascular Grafts
5,827,729   Diffusion Gradient Bioreactor and Extracorporeal Liver Device
            Using a Three-Dimensional Liver Tissue
5,830,708   Methods for Production of a Naturally Secreted Extracellular Matrix
5,842,477   Method for Preparing Cartilage
5,843,766   Apparatus for the Growth and Packaging of Three Dimensional
            Tissue Cultures
5,846,828   Apparatus and Method for Sterilizing, Seeding, Culturing,
            Storing, Shipping and Testing Tissue, Synthetic, or Mechanical
            Heart Valves or Valve Segments
5,849,588   Methods of Use of a Three-Dimensional Liver Cell and Tissue
            Culture System
5,858,721   Three-Dimensional Cell and Tissue Culture System
5,863,531   In Vitro Preparation of Tubular Tissue Structures by Stromal Cell
            Culture on a Three-Dimensional Framework
5,902,741   Three Dimensional Cartilage Cultures
5,919,702   Production of Cartilage Tissue Using Cells Isolated From
            Wharton's Jelly

5,928,945   Application of Shear Flow Stress to Chondrocytes or Chondrocytre
            Stem Cells to Produce Cartilage
5,962,325   Three-Dimensional Stromal Tissue Cultures
6,008,049   Diffusion Gradient Bioreactor and Extra-Corporeal Liver Device
6,022,743   Three-Dimensional Culture of Pancreatic Parenchymal Cells
            Cultured Living Stromal Tissue Prepared In Vitro
6,027,935   Gene Up-Regulated in Regenerating Liver
6,060,306   Apparatus and Method for Sterilizing, Seeding, Culturing, Storing,
            Shipping and Testing Replacement Cartilage Tissue Constructs
6,121,042   Apparatus and Method for Simulating In Vivo Conditions While
            Seeding And Culturing Three-Dimensional Tissue Constructs
6,140,039   Three-Dimensional Filamentous Tissue Having Tendon or Ligament
            Function
6,218,182   Method For Culturing Three-Dimensional Tissue in Diffusion
            Gradient Bioreactor and Use Thereof
6,284,284   Compositions and Methods for Production and Use of an Injectable
            Naturally Secreted Extracellular Matrix
6,291,240   Cells or Tissues With Increased Protein Factors and Method of
            Making Same

B. PENDING U.S. PATENT APPLICATIONS
08/488,165  Three-Dimensional Human Cell Cultures on Cardiac Valve Frameworks
            and Their Uses – on appeal
08/660,787  Compositions and Methods for Production and Use of an Injectable,
            Naturally Secreted Extracellular Matrix
09/256,649  Living Chimeric Skin Replacement
09/313,538  Conditioned Cell Culture Medium Compostions and Methods of Use
09/362,948  Genetically Engineered Cells Responsive to Environmental Cues
09/350,386  Human Naturally Secreted Extracellular Matrix-Coated Device and
            Methods for the Production and Uses Thereof
09/401,445  Three Dimensional Human Cell Cultures on Cardiac Valve Frameworks
            and Their Uses
09/411,585  Methods of Using a Three-Dimensional Stromal Tissue to Promote
            Angiogenesis
09/457,519  Application of Shear Flow Stress to Smooth Muscle Cells for the
            Production of Implantable Structures
09/482,203  Apparatus and Method for Sterilizing, Seeding, Cultiring, Storing,
            Shipping and Testing Tissue Synthetic or Native Vascular Grafts
09/603,642  Monitorable Three Dimensional Scaffolds and Tissue Culture
09/724,410  Cells or Tissues with Increased Protein Factors and Methods for
            Making Same
09/847,902  Container for Shipping Tissue
60/297,177  Compositions Comprising Conditioned Cell Culture Media and Uses
            Thereof

II. UNITED STATES PATENTS LICENSED TO ADVANCED TISSUE SCIENCES, INC.

A. LICENSED FROM THE MASSACHUSETTS INSTITUTE OF TECHNOLOGY
4,418,691   Method of Promoting the Regeneration of Tissue at a Wound
4,458,678   Cell-Seeding Procedures Involving Fibrous Lattices
4,505,266   Method of Using a Fibrous Lattice
4,638,045   Non-Peptide Polyamino Acid Bioerodible Polymers
4,806,621   Biocompatible, Bioerodible, Hydrophobic, Implantable Polyamino
            Carbonate Article
4,947,840   Biodegradable Templates for the Regeneration of Tissues
5,041,138   Neomorphogenesis of Cartilage In Vivo From Cell Culture
5,128,420   Method of Making Hydroxamic Acid Polymers From Primary Amide
            Polymers
5,399,665   Biodegradable Polymers For Cell Transplantation
5,514,378   Biocompatible Polymer Membranes and Methods of Preparation of Three
            Dimensional Membrane Structures
5,516,532   Injectable Non-Immunogenic Cartilage and Bone Preparation
5,654,381   Functionalized Polyester Graft Copolymers
5,736,372   Biodegradable Synthetic Polymeric Fibrous Matrix Containing
            Chondrocyte For In Vivo Production of a Cartilaginous Structure
5,759,830   Three-Dimensional Fibrous Scaffold Containing Attached Cells for
            Producing Vascularized Tissue In Vivo
5,770,193   Preparation of Three-Dimensional Fibrous Scaffold For Attaching
            Cells to Produce Vascularized Tissue In Vivo
5,770,417   Three-Dimensional Fibrous Scaffold Containing Attached Cells for
            Producing vascularized Tissue In Vivo
5,804,178   Implantation of Cell-Matrix Structure Adjacent Mesentery, Omentum or
            Peritoneum Tissue
6,123,727   Tissue Engineered Tendons and Ligaments
6,095,148   Neuronal Stimulation Using Electrically Conducting Polymers
6,224,893   Semi-Interpenetrating or Interpenetrating Polymer Network for Drug
            Delivery and Tissue Engineering

B. LICENSED FROM THE UNIVERSITY OF FLORIDA
5,650,299   Cells Producing Stem Cell Proliferation Factor
5,981,708   Stem Cell Proliferation Factor

License Grant

The Licensor entered into an exclusive License Agreement with the Licensee for the sales and marketing of Orcel product.

License Property

The product is a collagen sponge seeded with allogeneic epidermal and dermal cells. These cells secrete growth factors and cytokines normally found in acute human wounds and are believed to have a beneficial role in promoting tissue repair.

OrCel® is a bilayered cellular matrix in which normal human allogeneic skin cells (epidermal keratinocytes and dermal fibroblasts) are cultured in two separate layers into a Type I bovine collagen sponge.  Donor dermal fibroblasts are cultured on and within the porous sponge side of the collagen matrix while keratinocytes, from the same donor, are cultured on the coated, non-porous side of the collagen matrix.

Field of Use

Field of use relates to the medical industry.

License Grant

Licensor hereby grants to Licensee the exclusive worldwide right and license under the Patent Rights to make, have made, use, lease and sell the licensed products and licensed services and to practice the licensed processes in the field of use to the end of the term for which the Patent Rights are granted.

License Property

Technology refers to the tissue engineering technology.

Patents relate to tissue engineering and polymer science with specific applications to the breast tissue and urological fields.

Field of Use

This agreement Is amended to include rights to certain patents related to a second generation technology of polymer science for all fields.  This research has applications in the fields of orthopedics, maxillofacial repair and wound healing.