Royalty Report: Medical, Device, Packaging & Containers – Collection: 1957

License Grant

The Company entered into an exclusive manufacturing and distribution agreement with Japanese company for the territory of Japan for the CryoSeal System.

License Property

The CryoSeal System is a small, floor-standing thermodynamic device and special blood processing container which harvests Cryo from a donor's blood plasma; an automated rapid method of preparing cyroprecipitated AHF (Cryo) –a biological product licensed (approved) by the FDA for intravenous treatment of hemophilia; the Autologous Tissue Sealant System comprises Thermogenesis' thermodynamic device for controlling plasma temperature, a sterile plasma collection-and-harvesting bag and disposable applicators.  The system allows the rapid harvesting of cryoprecipitate – or concentrated clotting proteins, including fibrinogen – that can be used by surgeons to control bleeding and seal tissues during surgery.

United States, Serial No. 07789293 – Device for Fractionating Constituent Components of a Substance using Cryoprecipitation and Serial No. 08005989 — Fibrinogen Processing  Apparatus Method and Container, covering said inventions (The Patent Applications) and is preparing additional patent application, all of which either have been and/or will be filed in Japan.

Field of Use

The rights granted apply for intravenous treatment of hemophilia and relating to the design and manufacture of a freezing and thawing System for the rapid harvesting of cryoprecipitate from human plasma.

License Grant

Licensor shall grant to Licensee and Affiliates under CyroSeal II Intellectual Property, and for the life of such CyroSeal II Intellectual Property, a non-exclusive, royalty bearing, license to make, use, offer to sell, sell, and import Products throughout the Territory for use in the Field of Use. Licensee shall have the right to grant sublicenses to others under the CyroSeal II Intellectual Property to import, distribute, offer to sell, sell, and obtain regulatory clearances for Products.

License Property

Product(s) means a fibrinogen concentration kit containing Licensor’s CryoSeal II Kit (minus Fibrinogen Reagent) and Licensee’s Plasma Fractioning Tube, ACD-A anti-coagulant, labeling per Licensee’s direction, and instructions.

CryoSeal II Kit is known as a product which harvests a fibrinogen rich solution of adhesive & clotting proteins.

CryoSeal II Kit means Licensor’s fibrinogen plus disposable, labeling as specified by Licensee, and applicators contained in a sterile package.

CyroSeal II Intellectual Property means Licensors Intellectual Property required to make, use, offer for sell, sell, and import the Product.

Field of Use

This agreement pertains to the drug industry relating to products that process autologous human cells, such as contained in blood, to product therapeutic products.   Field of Use means surgical hemostats, graft delivery systems, and surgeries.

The product will feature a fibrinogen harvesting disposable in combination with Licensee's Clotalyst(TM) System that can produce fibrin sealant from a patient's own blood in less than 30 minutes. Fibrin sealant is an adhesive gel used by surgeons to stop bleeding and bond tissue.

Licensee plans to combine Licensor's protein harvesting technology with its currently offered and future autologous therapies to manufacture autologous fibrin sealant in a peri-operative setting.

The product will feature a fibrinogen harvesting disposable in combination with Licensee's Clotalyst(TM) System that can produce fibrin sealant from a patient's own blood in less than 30 minutes. Fibrin sealant is an adhesive gel used by surgeons to stop bleeding and bond tissue.

License Grant

Licensor appoints the Japanese Licensee as Licensor’s exclusive distributor within the Territory and Asian Pacific Rim Countries to market, distribute and sell the Product, including TAD Stand Alone, to be supplied by Licensor for any purpose, including, but not limited to, surgical procedures and regeneration medical treatment.

Licensor grants the exclusive right and license, with the right to sublicense for marketing and manufacturing purposes only, to use all trademarks with respect to the Product owned by Licensor in connection with the manufacturing, marketing, distribution, sale and post-sale field service, technical assistance and support of its rights hereunder in the Territory and Asian Pacific Rim Countries.

License Property

The product line is for innovative products and services that process and store adult stem cells, including the CryoSeal Fibrin Sealant System wound care product line.

The CryoSeal Fibrin Sealant (FS) System is a medical device that simultaneously produces cryoprecipitate and thrombin from a unit of autologous plasma. When components are mixed they form a fibrin sealant for use in liver resection surgery as an adjunct to hemostasis.  CryoSeal Fibrin Sealant System wound care product line allows the production of fibrin sealant from a single unit of human plasma.

Field of Use

The CryoSeal FS System is intended for the preparation of fibrin sealant from a unit of autologous plasma in a closed, sterile fluid path. The autologous fibrin sealant is indicated for use as an adjunct to hemostasis on the incised liver surface in patients undergoing liver resection when control of bleeding by standard surgical techniques is ineffective or impractical.

License Grant

In 1996, the Company and the NYBC, as co-licensors, entered into a license agreement for the manufacture and distribution rights to the sterile, medical disposable PCB processing containers were licensed to a Japanese company for exclusive manufacture and marketing in Japan for the system of sterile, medical disposable containers developed by the Company and NYBC for the processing of hematopoietic stem cells sourced from PCB.

License Property

IP relates to placental cord blood ('PCB') bag sets, submitted a New Drug Application ('NDA') with the FDA for the PCB collection bag set, and a 510(k) application for the PCB processing and transfusion bag sets.

These bag sets streamline the protocol for collecting, cryopreserving and transfusing PCB stem cells and feature a novel freezing bag which is designed to be controlled-rate frozen and stored in the BioArchive device at -196{o} C.

License Grant

The Licensor of Australia grants an exclusive license under the Licensed Patents, and to the Licensed Invention, to make, use, import, offer to sell, and sell compositions of matter, methods and processes which are covered under the Licensed Patents, and/or which are encompassed by the Licensed Invention, in any and all Fields of Use, with the right to grant sublicenses.

License Property

The license pertains to patents, know-how and other intellectual property relating to our foundation technology for removal of lipids from proteins and our continued operations at present are dependent upon such license.

Licensed Invention means any composition of matter, method or process relating to alterations in the lipid structure of biological material; e.g., including, but not limited to, delipidization of soft tissue, e.g., atheroma, inactivation of lipid-enveloped organisms, e.g., viruses, as well as know-how, materials, trademarks, copyrights and technology which has or may be acquired by or on behalf of either or both of the Licensor, and which is useful in or necessary toward the development, optimization and/or commercialization of any composition of matter, method or process defined by the claims of the Licensed Patents.

Technology is based on a process of selective, systemic removal of lipids from plasma, or blood without red cells. This process is known as plasma delipidation. The process is designed to provide therapeutic benefit by enhancing the body's natural ability to heal itself. We believe that through the use of this system a patient's risk of such common disorders as heart attack and stroke will be reduced, and circulation throughout the body will be improved with numerous attendant benefits.

– United States Patent No. 5,911,698, entitled 'Treatment for Cardiovascular and Related Diseases';

– United States Patent No. 5,744,038, entitled 'Solvent Extraction Methods for Delipidating Plasma';

– United States Patent No. 4,895,558, entitled 'Autologous Plasma Delipidation Using a Continuous Flow System';

– Australian Patent Counterparts to the United States Patents Australian Patent Nos. 594964, 693458 and 695826, respectively, as well as six pending foreign patent applications related thereto;

– Pending PCT application entitled A Method of Treating Infectious Diseases;

– Pending PCT application entitled A Viral Vaccine

Field of Use

The Field of Use means any activity, research or endeavor to which the Licensed Invention and Licensed Patents may be applied.

License Grant

The Company and the NYBC, as co-licensors, entered into a license agreement in which the Licensees became the exclusive worldwide manufacturers and distributors (excluding Japan) for the system of sterile, medical disposable containers developed by the Company and NYBC for the processing of hematopoietic stem cells sourced from PCB.  Licensor grants to Licensee, under the terms and conditions of this Agreement, an exclusive license within the Exclusive Field of Use and the Non-Exclusive Field of Use under the Licensed Patent Rights and Know-How (a) to make, use, sell, or otherwise dispose of the Licensed Products, and (b) to use the methods covered by the Licensed Patent Rights and Know-How for the manufacture, use and sale of Licensed Products. Licensor retains for itself the right to practice for itself, without the right to sublicense distribution, the Licensed Patent Rights and Know How within the Non-Exclusive Field of Use and to use the methods covered by the Licensed Patent Rights and Know-How.

License Property

Licensor has developed know-how and patent rights for plastic disposable bags or containers for the isolation, collection, processing, freezing and infusion of stem cells for use with placental/umbilical cord blood.

Method of Isolation of Stem Cells and Bag Array U.S. #08/349,747
Improved Bag Design and Method of Manufacturing U.S. #08/670,368

Field of Use

Exclusive  Field  of Use@ shall mean the practice of stem cell  isolation and collection from umbilical cord blood, and the freezing, storage, processing and infusion of such stem  cells.
Non-Exclusive Field of Use@ shall mean all other applications of the Licensed Product.

License Grant

The Licensor, a company organized under the laws of Germany hereby grants to Licensee a perpetual, non¬exclusive, transferable license to make, use, sell and otherwise practice the Proprietary Technology, and to grant sublicenses to others to make, use, sell and otherwise practice the Proprietary Technology in accordance with the terms set forth herein (the “License”).

License Property

The Licensor is the owner of a proprietary process, described in U.S. Patent Application Serial Number 1 0/854,622 entitled “Sterile System and Methods for Collecting, Transporting, Storing and Cryopreserving Body Fluids” and any continuations, continuation-in-parts, divisionals or reissues thereof (the “Sterile System Patent Applications”), together with certain know-how and other proprietary information related thereto (collectively with the Sterile System Patent Applications, the “Sterile System Proprietary Technology”) as currently employed at Bergen Community Blood Services on behalf of Corcell. A copy of the U.S. Sterile System Patent Application is attached to this Agreement as Schedule A. The Sterile System Proprietary Technology is referred to herein as the “Proprietary Technology”.

Field of Use

The Licensee specializes in providing private cord blood stem cell preservation services to families.