Royalty Report: Drugs, Biotechnology, Stem cells – Collection: 7568

License Grant

The Licensor will convey, assign, deliver and set over to the Swiss Licensee and the Licensee will purchase and accept, all of the right, title, benefit and interest of the Licensor in, to and under the Acquired Assets, free and clear of all Liens. Acquired Assets include he Assigned Books and Records; the Assigned Contracts; the Assigned Intellectual Property; the Assigned Regulatory Materials and Authorizations.

License Property

“ceMSC” means any and all culture expanded mesenchymal stem cells.

A Combnation Product refers to means an Earnout Product that incorporates at least one clinically active or other component with independent value in addition to ceMSCs contained therein.  All references to “Earnout Product” in this Agreement shall be deemed to include Combination Products.

Prochymal is a stem cell drug therapy. It is for acute graft-vs-host disease (GvHD). It is an allogenic stem therapy based on mesenchymal stem cells derived from adult bone marrow.

License Grant

Licensor grants an exclusive, even as to Licensor, except as required for Licensor to meet its development and supply obligations hereunder, right and license, with the right to sublicense, during the Term of this Agreement under the Licensor Intellectual Property and Licensors interest in any Joint Patent Rights and Joint Technology solely to research, develop, make, have made, use, sell, offer for sale and import Products in the Field in the Licensee Territory, and a non-exclusive right and license, with the right to sublicense, during the Term of this Agreement under the Licensor Intellectual Property to research, make, have made, use and export Products in the Field in North America.

License Property

Licensor is a stem cell therapeutic leader focused on developing and marketing products to treat medical conditions and possesses broad scientific and clinical leadership in the field of human mesenchymal stem cells (MSCs) and know-how, expertise and intellectual property rights pertaining to MSCs, including its Prochymal product and Chondrogen product.

Chondrogen shall mean any formulation, dosage form or delivery system that contains culturally expanded, undifferentiated, unmodified human MSCs for local delivery for the Articulating Orthopedic Indication and any Improvements thereto.

Prochymal shall mean any formulation, dosage form or delivery system suitable for Vascular Administration that contains culturally expanded, undifferentiated, unmodified human MSCs, and any Improvements thereto.

Ulcerative Colitis Indication shall mean the use of Prochymal for the treatment or prevention of ulcerative colitis.

Mesenchymal Stem Cells or MSCs shall mean the human formative pluripotential blast cells found inter alia in bone marrow, blood, dermis and periosteum that are capable of differentiating into any of the specific types of mesenchymal or connective tissues.

COPD Indication shall mean the use of Prochymal to treat chronic obstructive pulmonary disease.

Articulating Orthopedic Indication shall mean the use of Chondrogen for preventing or treating diseases, defects or conditions of articulating joints, including cartilage and meniscus repair, osteoarthritis, osteochondral defect repair, and the treatment of acute and chronic orthopedic pain within an articulating joint.

Crohns Indication shall mean the use of Prochymal to treat Crohns disease.

Diabetes Indication shall mean the use of Prochymal for the prevention or treatment of Type I diabetes.

GvHD Indication shall mean the use of Prochymal to treat or prevent graft versus host disease.

Cardiac Indication shall mean the use of Prochymal to treat or prevent acute myocardial infarction.

Pain Therapeutic shall mean use of Chondrogen for the mitigation or relief of orthopedic pain with a Statistically Significant duration of relief of at least one year.

Field of Use

Field shall mean with respect to Prochymal, all applications for the prevention or treatment of diseases, defects, or conditions in humans, and with respect to Chondrogen, the Articulating Orthopedic Indication.

License Grant

The Licensee obtained a non-exclusive License to distribute human embryonic stem cell lines made by the Licensor through stem cell banks.

License Property

The term “stem cells” describe all of the cells that can give rise to the different cells found in tissues.  Cells from the same pluripotent stem cells can be used in any patient. This type of cell therapy is referred to as “allogeneic”. This permits the use of a single master stem cell bank in the manufacturing of the therapeutic doses to be used such that one uniform source of starting cells can be readily controlled for consistency, lack of infectious agents and cleared by regulatory agencies.

License Grant

We entered into an Agreement with the Licensor for collaboration in the preparation and execution of development and purchase Agreements with United States and Allied government agencies for countermeasures to nuclear terrorism and other radiological emergencies.

License Property

Prochymal is a stem cell drug therapy.  Prochymal, which is made from mesenchymal stem cells found in adult bone marrow, is in late-stage human clinical trials for other uses, including the treatment of Crohn's disease.  Its development partner will receive development costs and a royalty on sales if the drug is approved for use.

Field of Use

In January 2008, we were awarded a contract from the United States Department of Defense for the development and stockpiling of Prochymal for the treatment of Acute Radiation Syndrome. Under the terms of the contract, the DoD will provide technology and product development funding to us up to $24.7 million. The contract further provides for additional funding for activities leading to FDA approval of Prochymal for ARS and the scaling up of manufacturing processes, and provides the DoD with successive options for the purchase of up to 20,000 doses of Prochymal in the aggregate.  We will carry out this contract in partnership with the Licensor, with us contributing Prochymal and our corresponding safety and advocacy database to the effort, and with the Licensor lending its mass product development and large scale commercialization expertise.

License Grant

The Licensor grants the Licensee an exclusive, royalty bearing License under the Licensed Rights and Licensed Patents to make, have made, use, sell, offer for sale, import and export adipose-derived stem and regenerative cell based treatments and therapies for Autoimmune Diseases, throughout the United States and its territories.

License Property

The Licensor is the owner of all right, title and interest in and to United States patent No. 8,241,621, entitled Stem Cell Mediated Treg Activation and related rights.

Field of Use

The Licensee is engaged in the business of adipose-derived stem and regenerative cell based therapies.

License Grant

The Spanish University patent families referred to as PCX006 and PCX007 are the subject of a co ownership agreement with the Spanish Licensee. Under the terms of this agreement, the University assigned all exploitation rights, including the right to license or sub-license to third parties.

License Property

University signed an agreement for the Assignment of the Rights to Exploit Spanish invention patents no. 200402355, entitled “IDENTIFICATION AND ISOLATION OF MULTIPOTENT CELLS FROM NON-OSTEOCHONDRAL MESENCHYMAL TISSUE”, and no. 200402083, entitled “Biomaterial for suture”

PCX006 is a patent family claiming a non osteochondral derived multipotent adult stem cell population characterized by a set of biological markers.
PCX007 is a patent family claiming an adipose derived stem cell composition characterized by a panel of cell surface markers, methods of preparation of such a composition and adipose tissue derived stromal stem cells in treating fistula and wounds.

(WO2006037649/11/167,061) IDENTIFICATION AND INSOLATION OF MULTIPOTENT CELLS FROM NON-OSTEOCHONDRAL MESENCHYMAL TISSUE
The present invention relates to isolated multipotent adult cells which are isolated from non-osteochondral mesenchymal tissue and are characterized by the presence and absence of a set of cell surface markers. The invention also relates to a method for identifying and isolating a population of said cells, as well as to the applications thereof, for example, in the manufacture of a pharmaceutical composition for the repair and regeneration of tissues.

Field of Use

The Licensee is an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from our proprietary technology platforms of allogeneic, or donor-derived, stem cells.

License Grant

We acquired the Exclusive worldwide rights to US Patent # 6129911, for Liver Stem Cells from Licensor, a non-profit  hospital.  The invention provides a primary liver stem cell and a cell doublet consisting of a hepatocyte and the stem cell, both of which are derived from normal liver tissue. Methods of isolating the cells, genetically altering the cells, and using the cells for transplantation are also within the invention.  This patent contains twenty-four claims to a method of obtaining a population of liver cell clusters from adult stem cells and is an important enhancement to the Company's adult stem cell portfolio.

License Property

The invention provides a primary liver stem cell and a cell doublet consisting of a hepatocyte and the stem cell, both of which are derived from normal liver tissue. Methods of isolating the cells, genetically altering the cells, and using the cells for transplantation are also within the invention.  This patent contains twenty-four claims to a method of obtaining a population of liver cell clusters from adult stem cells and is an important enhancement to the Company's adult stem cell portfolio.  (The Company has an exclusive, long-term license agreement for use of the following patents owned by the hospital related to liver cell lines and Liver Assist Devices (LADs)  US Patent #6,017,760, Isolation and Culture of Porcine Hepatocytes, expires October 9, 2015;  US Patent #6,107,043, Immortalized Hepatocytes, expires February 8, 2019;  US Patent #5,043,260, Perfusion Device for Hepatocytes, expires August 27, 2008;  US Patent #4,795,459, Implantable Prosthetic Device (Endothelial), expires January 3, 2006;  US Patent #6,129,911, Liver Stem Cell, expires October 10, 2017;  US Patent #6,858,146, Artificial Liver Apparatus and Method (Sybiol), expires on February 20, 2019; and  US Patent #6,872,389, Liver Stem Cell, expires on July 8, 2019.)

License Grant

The Licensee entered into a royalty Agreement with the Licensor and received the following assets from the Licensor

License Property

Certain patents and patent applications and all related active prosecution cases, trade secrets, know-how and certain other intellectual property rights, and all of the Licensor's goodwill with respect to the technology directly related to the research, development and commercialization of certain products and know-how related to hES cells;

Certain biological materials and reagents (including master and working cell banks, original and seed banks, and research, pilot and GMP grade lots and finished product);

Certain regulatory filings for clinical trials for GRNOPC-I for spinal cord injury, including the investigational new drug applications filed with the United States Food and Drug Administration for Licensor’s Phase I safety study of oligodendrocyte progenitor (GRNOPC-1) cells in patients with neurologically complete, subacute spinal cord injury (Protocol No. CP35A007), and long term follow up of subjects who received GRNOPC1 (Protocol No. CP35A008), and the clinical trial for VAC1 for acute myelogenous leukemia, including a Phase I/II study of active immunotherapy with GRNVAC1, autologous mature dendritic cells transfected with mRNA encoding human telomerase reverse transcriptase (hTERT), in patients with acute myelogenous leukemia (AML) in complete remission (Protocol No. CP06-151).

US Patent 6,800,480 – Methods and Materials for the Growth of Primate-Derived Primordial Stem Cells in Feeder-Free Culture
US Patent 7,413,902 – Feeder-Free Culture Method for Embryonic Stem Cells
US Patent 6,440,735 – Dendritic Cell Vaccine Containing Telomerase Reverse Transcriptase for the Treatment of Cancer
US Patent 7,402,307 – Method for Identifying and Killing Cancer Cells
US Patent 7,824,849 – Cellular Telomerase Vaccine and Its Use for Treating Cancer
US Patent 7,560,281 – Use of TGF Beta Superfamily Antagonists to Make Dopaminergic Neurons from Embryonic Stem Cells
US Patent 8,252,586 – Neural Cell Populations from Primate Pluripotent Stem Cells
US Patent 8,153,428 – Use of TGF Beta Superfamily Antagonists and Neurotrophins to Make Neurons from Embryonic Stem Cells
US Patent 6,667,176 – cDNA Libraries Reflecting Gene Expression During Growth and Differentiation of Human Pluripotent Stem Cells
US Patent 7,041,438 – Use of Human Embryonic Stem Cells for Drug Screening and Toxicity Testing
US Patent 7,413,904 – Embryonic Stem Cells Having Genetic Modifications
US Patent 7,410,798 – Culture System for Rapid Expansion of Human Embryonic Stem Cells
US Patent 7,297,539 – Medium for Growing Human Embryonic Stem Cells
US Patent 7,455,983 – Medium for Growing Human Embryonic Stem Cells
US Patent 8,097,458 – Culture System for Rapid Expansion of Human Embryonic Stem Cells
US Patent 6,642,048 – Conditioned Media for Propagating Human Pluripotent Stem Cells
US Patent 6,458,589 – Hepatocyte Lineage Cells Derived from Pluripotent Stem Cells
US Patent 6,506,574 – Hepatocyte Lineage Cells Derived from Pluripotent Stem Cells
US Patent 7,256,042 – Process for Making Hepatocytes from Pluripotent Stem Cells
US Patent 7,282,366 – Hepatocytes for Therapy and Drug Screening Made From Embryonic Stem Cells
US Patent 7,473,555 – Protocols for Making Hepatocytes from Embryonic Stem Cells
US Patent 8,148,151 – Differentiation of Primate Pluripotent Cells to Hepatocyte-Lineage Cells
US Patent 6,833,269 – Making Neural Cells for Human Therapy or Drug Screening from Human Embryonic Stem Cells
US Patent 8,148,148 – Neural Progenitor Cell Populations
US Patent 8,252,585 – Neural Progenitor Cell Populations
US Patent 7,250,294 – Screening Small Molecule Drugs Using Neural Cells Differentiated from Human Embryonic Stem Cells
US Patent 7,763,463 – Use of Cyclic AMP and Ascorbic Acid to Produce Dopaminergic Neurons from Embryonic Stem Cells
US Patent 6,576,464 – Differentiated Cells Suitable For Human Therapy
US Patent 6,921,665 – Selective Antibody Targeting of Undifferentiated Stem Cells
US Patent 7,732,199 – Process for Making Transplantable Cardiomyocytes from Human Embryonic Stem Cells
US Patent 7,763,464 – Differentiation Protocol for Making Human Cardiomyocytes
US Patent 7,452,718 – Direct Differentiation Method for Making Cardiomyocytes from Human Embryonic Stem Cells
US Patent 7,897,389 – Direct Differentiation Method for Making Cardiomyocytes from Human Embryonic Stem Cells
US Patent 7,851,167 – Differentiation Protocol for Making Human Cardiomyocytes

US Patent Application 13/561,296 – Neural Cell Populations from Primate Pluripotent Stem Cells
US Patent Application 12/170,219 – Culture System for Rapid Expansion of Human Embryonic Stem Cells
US Patent Application 12/710,078 – Culture System for Rapid Expansion of Human Embryonic Stem Cells
US Patent Application 13/323,567 – Culture System for Rapid Expansion of Human Embryonic Stem Cells
US Patent Application 11/917,993 – Suspension Culture of Human Embryonic Stem Cells
US Patent Application 12/277,136 – Protocols for Making Hepatocytes from Embryonic Stem Cells
US Patent Application 13/558,078 – Neural Progenitor Cell Populations
US Patent Application 11/359,341 – Differentiated Cells Suitable For Human Therapy
US Patent Application 11/471,916 – Differentiation of Primate Pluripotent Stem Cells to Cardiomyocyte-Lineage Cells

Field of Use

The Licensee is a biotechnology company focused on the emerging field of regenerative medicine, with core technologies centered on stem cells capable of becoming all of the cell types in the human body, a property called pluripotency.