Royalty Report: Medical, Supply, Tissue – Collection: 29009

License Grant

The University hereby grants Company the sole and exclusive, worldwide License to the Technology to develop, manufacture, use and sell Products.

License Property

Technology relate to developing Trade Secrets, Know-How and Patents dealing with methods, procedures and sciences relating to the science of enhancing fibroblast and other cellular ingrowth into homograft, xenograft and bioprosthetic grafts. Patent shall mean U.S. patent number 5,192,312.

An implantable human heart valve treated with growth factor effective on fibroblast cells and populated with fibroblast cells in an amount and for a time period effective for rendering the heart valve substantially non-immunogenic upon implant into a mammal.  An implantable non-human mammalian heart valve treated with growth factor effective on fibroblast cells and populated with fibroblast cells in an amount and for a time period effective for rendering the heart valve substantially non-immunogenic upon implant into a mammal.

License Grant

The Licensee announced the settlement of its ongoing litigation with the Licensor relates to a tissue-grafting technology–tissue engineering patents, trade secrets and know-how relating to tissue decellularization and recellularization.

License Property

This technology is used in heart valves and vascular grafts.

Orton Patents include, but are not limited to, U.S. Patent Nos. 5,192,312; 5,772,695; 5,863,296; 5,855,617, and U.S. Provisional Application Serial No. 60/219,548 as well as corresponding Non-Provisional Application Serial No. 09/909914 and PCT Application Serial No. PCT/US01/22018.  
Goldstein Patents shall mean U.S. Patent Nos. 5,613,982; 5,632,778; 5,843,182; 5,899,936; and all pending and future applications and patents, both U.S. and foreign, arising from these patents, as well as any continuations, continued prosecution applications, continuations-in-part, divisions, or substitutions thereof.  

Tissue Decellularization Patent Applications shall mean U.S. Application Serial Nos. 08/838,852 and 09/735,522 and all pending and future applications.  

Tissue Graft Patent Applications shall mean U.S. Application Serial Nos. 60/178,632 and 09/769,769 and all pending and future applications and patents.

Unstented Heart Valve Patent Applications shall mean U.S. Application Serial No. 09/540,525 and all pending and future applications and patents, both U.S. and foreign, arising from these patents, as well as any continuations, continued prosecution applications, continuations-in-part, divisions, or substitutions thereof.

License Grant

Licensor, non-profit health care organization, 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 University grants an exclusive, license, including the right to grant sublicenses, under the Patent Rights, to make, have made, sell, offer for sale, have sold, use, import, and have imported Licensed Products in the Field.

License Property

The patents are for Non-Human Mammal Having a Graft and Methods of Delivering Protein to Myocardial Tissue; and. Myocardial Grafts and Cellular Composition.

Field of Use

Licensee develops and manufacture fully functioning human cells in industrial quantities to precise specifications. Licensee's proprietary iCell Operating System (iCell O/S) includes true human cells in multiple cell types (iCell products), human induced pluripotent stem cells (iPSCs) and custom iPSCs and iCell products (MyCell products). iCell O/S products provide standardized, easy-to-use, cost-effective access to the human cell, the smallest fully functioning operating unit of human biology. Customers use iCell O/S products, among other purposes, for drug discovery and screening; to test the safety and efficacy of their small molecule and biologic drug candidates; for stem cell banking; and in researching cellular therapeutics.

License Grant

In light of a collaboration agreement entered into between the Licensee and a Sublicensee the Licensee of Israel and the Israeli Licensor, the technology transfer company of the University, have agreed to amend the License Agreement.

The Licensee acknowledges that the rights granted by it to Sublicensee pursuant to the Collaboration Agreement in respect of what is defined thereunder as the Second Product, the Licensee hereby declaring that what is defined as the First Product thereunder has never been and never will be developed, include the grant of rights to use Licensors rights in the Licensed Information and/or the Joint Patents.

The original agreement is non-exclusive.

License Property

The Collaboration Agreement shall mean a collaboration entered into between the Licensee and Sublicensee.  The Collaboration Agreement shall thus constitute a Sublicense.

The sublicense collaboration is for FGF or fibroblast growth factor variant.

The fibroblast growth factors are a family of cell signalling proteins that are involved in a wide variety of processes, most notably as crucial elements for normal development.

Field of Use

Sublicensee is in the Musculoskeletal Transplant field.   All FGF or fibroblast growth factor variant provided to SubLicensee in connection with the Second Product pursuant to the Collaboration Agreement shall either be sold by Licensee by way of incorporation in the Second Product, or shall be used for clinical trials purposes.

The Licensee focuses on modulating the fibroblast growth factor system to enable it to create solutions for tissue regeneration.

License Grant

By the 2003 agreement, Licensor granted an exclusive worldwide sublicense for the Licensed Technology in the Field of Use and the Field of Extended Use.  This amended and restated agreement is to continue the Exclusive Sublicense with the amendments.

Licensor grants an exclusive worldwide license under the Licensed Technology to use, offer to sell, sell, and otherwise commercialize, solely in the Field of Use and the Field of Extended Use, Licensed Products which include rhPDGF-BB purchased from Licensor.

For the Sublicenses, Licensor grants the right to grant sublicenses under the Licensed Technology to Distributors to use, offer to sell and sell, in the Field of Use and the Field of Extended Use, Licensed Products purchased from Licensor.

License Property

Licensed Products means any product consisting essentially of rhPDGF-BB in the absence of other growth-promoting proteins and in combination with a synthetic or natural matrix, or any part thereof i.e., any product consisting essentially of rhPDGF-BB in the absence of other growth-promoting proteins without a matrix, or a synthetic or natural matrix alone, that is covered by the Licensed Patents; is developed through the use of a process that is covered by the Licensed Patents or could not be manufactured, used or sold without the incorporation or use in whole or in part of some or all of the Licensed Patents.

Proven rhPDGF technology is FDA approval of GEM 21S for periodontal bone regeneration suggests potential for efficacy in other bone and musculoskeletal applications.

Field of Use

GEM 21S was approved by the U.S. Food and Drug Administration the treatment of periodontal bone defects and gum tissue recession associated with periodontal disease.

GEM 21S® growth-factor enhanced matrix is indicated to treat the following periodontally related defects intrabony periodontal defects; furcation periodontal defects; and gingival recession associated with periodontal defects.

GEM 21S® growth-factor enhanced matrix combines a bioactive protein – highly purified rhPDGF-BB – with an osteoconductive matrix, ß-TCP.

GEM 21S® is the only dental therapy containing rhPDGF-BB, one of the main growth factors found in the human body and well known for its stimulatory role in wound healing.

This completely synthetic grafting system is engineered to stimulate wound healing and bone regeneration when implanted in the body by triggering a cascade of molecular events that continues on even after the implanted rhPDGF-BB is gone.

The Field of Use means all uses related to the treatment, cure, or relief of mammals for periodontal diseases and/or the repair, restoration or reconstruction of oral and cranio• maxillofacial osseous defects.

The Field of Extended Use shall mean all uses outside the Field of Use that are related to the treatment and healing of bone, cartilage, tendon and ligaments of the skeletal tissue system in animals, excluding humans, excluding the treatment and healing of soft tissue wounds.

License Grant

The Company, Licensee, was assigned the intellectual property and patent rights to certain products by an undisclosed Licensor. The term of this license is perpetual and allows for the worldwide exclusive rights to manufacture and market the product.

License Property

The product is Novagold(TM)  breast implants.  Products are manufactured pursuant to Licensee owned patents or patents for which the Licensee is the exclusive licensee.

NOVAGOLD is a pre-filled hydrogel textured single lumen breast implant that utilizes a unique water based filling material that is designed to be biocompatible.

The Licensee Patents and applications relate to alternative fill material, textured shell surface, water vapor barrier shell, biocompatible catheter and saline implant with single valve.

Field of Use

The Licensee produces its own products through wholly owned subsidiaries located in Minneapolis,   Minnesota and Monheim, Germany.