Royalty Report: Drugs, Biotechnology, Therapeutic – Collection: 7236

License Grant

The parties entered into a development and commercialization agreement, which was superseded by this exclusive development and license agreement, pursuant to which each party exclusively licensed to the other certain patent rights and technology for use in defined fields and pursuant to which one party agreed to provide certain related services.

License Property

Licensor licenses certain patent rights to us that are useful to

•human somatic cell nuclear transfer applications for therapeutic purposes and

•the cloning of animals for agricultural purposes, for the production of recombinant proteins, peptides and polypeptides for human transplantation, cells for human transplantation and tissues from human transplantation, but excluding the Licensor's field.

Field of Use

Licensee is a biotechnology company focused on developing and commercializing human stem cell technology in the emerging field of regenerative medicine.

License Grant

The University Licenses to the Licensee certain patent rights relating to the cloning of non-human animals for use in connection with the development, manufacture and sale of products and services in the field of non-human animals for agriculture, companion animals, research and diagnostic products, non-human and human therapeutics, and neutraceuticals, except production of immunoglobulin in the blood of Bos taurus and Bos indicus.

Field of Use

Licensee is focused on developing and commercializing human stem cell technology in the emerging field of regenerative medicine. Our plan is to successfully develop and commercialize products for use in treatment of a wide array of chronic degenerative diseases and in regenerative repair of acute disease, such as trauma, infarction and burns.

License Grant

Licensor hereby grants to Licensee, and Licensee hereby accepts, subject to the terms and conditions hereof, a royalty bearing, exclusive license in the Territory in the Field and under the Licensed Technology to (a) research, develop, make, have made, use, sell, offer for sale, import and export Licensed Products, (b) research, develop, use, practice, sell, offer for sale, import and export Licensed Processes and (c) develop, use, perform, sell, offer for sale, import and export Licensed Services. By way of example, but not in limitation, Licensee shall have the right to use Licensed Technology within the Field to produce mammalian embryonic stem (ES) cells and to produce from those mammalian embryonic cells, differentiated cells for human therapeutic purposes or for commercial research purposes, including drug screening assays, and to produce pluripotent cells including ES cells, differentiated human cells for human diagnostic and therapeutic purposes and/or for commercial research purposes, including drug screening assays.

License Property

60/382,616 Nuclear Transfer-Generated Stem Cells for Transplantation Having Homozygous MHC Alleles, and Methods for Making and Using Such a Stem Cell Bank

09/736,268 Transfer to De-Differentiate Recipient Cells

Field of Use

Field shall mean (1) the research, development, manufacture and selling of human and non-human animal cells for commercial research use, including small molecule and other drug testing and basic research and (2) the manufacture and selling of human cells for therapeutic and diagnostic use in the treatment of human (a) diabetes and (b) liver diseases; but Field shall exclude applications involving the use of cells in the treatment of tumors where the primary use of the cells is the destruction or reduction of tumors and does not involve regeneration of tissue or organ function.

License Grant

Licensor hereby grants to Licensee, and Licensee hereby accepts, subject to the terms and conditions hereof a) A royalty bearing, exclusive license in the Territory in the Field and under the Licensed Technology to (a) research, develop, make, have made, use, sell, offer for sale, import and export Licensed Products, (b) research, develop, use, practice, sell, offer for sale, import and export Licensed Processes and (c) develop, use, perform, sell, offer for sale, import and export Licensed Services.

By way of example, but not in limitation, Licensee shall have the right to use Licensed Technology within the Field for the following purposes to produce mammalian embryonic stem (ES) cells and to produce from those mammalian embryonic cells, differentiated cells for human therapeutic purposes or for commercial research purposes, including drug screening assays, and to produce pluripotent cells including ES cells, differentiated human cells for human diagnostic and therapeutic purposes and/or for commercial research purposes, including drug screening assays. b) A royalty bearing, twelve (12) month exclusive license in the Territory in the Field to expand in culture, prepare for sale, sell, offer for sale, import and export Act Animal Cell Lines. The twelve-month term of exclusivity granted to Licensee shall begin upon the date of the first sale of the Act Animal Cell Lines. Licensor and Licensee agree that after the twelve-month period of exclusivity has passed, Licensor and Licensee shall negotiate in good faith to establish reasonable minimum sales goals over reasonable evaluation periods in order to maintain Licensee’s exclusive rights hereunder. If Licensor fails to meet the minimum sales goals then Licensee’s exclusive rights shall revert to nonexclusive rights.

License Property

“Act Animal Cell Lines” shall mean cell lines of non-human animal origin developed by Act. These cell lines shall include but not be limited to murine and primate embryonic stem cells derived through parthenogenesis, nuclear transfer or otherwise isolated from fertilized blastocysts including the relevant information Licensor possesses associated with these cells, including but not limited to information on the cell’s karyotype, gene expression and growth characteristics.

PATENT RIGHTS
08/935,052  US 1997-09-22 CICM Cells and Non-Human Mammalian Embryos

6,235,970 2001-05-22  Prepared by Nuclear Transfer of a Proliferating Differentiated Cell or its Nucleus

09/828,876 US 2001-04-10 Cloning Using Donor Nuclei from Differentiated Fetal and Adult Cells UMASS

10/374,512 US 2003-02-27 Gynogenetic or Androgenetic Production of Pluripotent Cells and Cell Lines, and Use Thereof to Produce Differentiated Cells and Tissues

60/161,987 US 1999-10-28 Gynogenetic or Androgenetic Production of Pluripotent Cells and Cell Lines, and Use Thereof to Produce Differentiated Cells and Tissues

2,387,506 CA 2000-10-27 Gynogenetic or Androgenetic Production of Pluripotent Cells and Cell Lines, and Use Thereof to Produce Differentiated Cells and Tissues

Declared patent interferences
a) Patent Interference No. 104,746, involving U.S. Patent No. 5,945,577 and U.S. Patent Application No. 09/650,194.

b) Patent Interference No. 105,192, involving U.S. Patent No. 6,235,970 and U.S. Patent Application No. 09/989,126.

Potential patent interferences, verbally threatened to be filed against the following patents
a) 6,215,041

b) 6,235,969

Field of Use

“Field” shall mean (1) the research, development, manufacture and selling of human and non-human animal cells and Act Animal Cell Lines for commercial research use, including small molecule and other drug testing and basic research, (2) the manufacture and selling of human cells for therapeutic and diagnostic use in the treatment of human (a) diabetes and (b) liver diseases, and (3) the use of Act Animal Cell Lines in the process of manufacturing and selling human cells for therapeutic and diagnostic use in the treatment of human (a) diabetes and (b) liver diseases but where the final marketed product does not include Act Animal Cell Lines (i.e. does not include the field of xenotransplantation); but Field shall exclude applications involving the use of cells in the treatment of tumors where the primary use of the cells is the destruction or reduction of tumors and does not involve regeneration of tissue or organ function.

License Grant

We entered into a development and commercialization agreement with Licensee, which was superseded by an exclusive development and license agreement, pursuant to which each party exclusively licensed to the other certain patent rights and technology and pursuant to which we agreed to provide certain related services.

Under the agreement, we agreed by September 1, 2000, to produce at least 20 cloned hSA cows (cows produced with our technology that are transfected with a GTC recombinant DNA construct and contain the hSA transgene and express hSA in their milk for the purpose of transgenic production of milk products.)

License Property

Under the agreement, we license to Licensee certain patent rights and know-how useful to the cloning of animals for all purposes for the production of biopharmaceutical agents in milk, including, but not limited, proteins, peptides and polypeptides for pharmaceutical, neutraceutical or other use.

License Grant

Licensor hereby grants to Licensee, a royalty bearing, exclusive, worldwide License in the Field of  research, development, manufacture and selling of human cells for cell therapy in the treatment of human diabetes and liver diseases.

License Property

The Technology is to research, develop, make, have made, use, sell, offer for sale, import and export Licensed Products, Processes and Services to produce human embryonic stem cells and to produce from those mammalian embryonic cells, differentiated cells for human cell therapy within the Field, and to produce pluripotent cells including ES cells, differentiated human cells for cell therapy within the field.

5,453,366 Method of Cloning Bovine Embryos

6,011,197 Method of Cloning Bovines Using Reprogrammed Non-mbryonic Bovine Cells

6,258,998 Method of Cloning Porcine Animals

5,843,754 Parthenogenic Bovine Oocyte Activation

5,496,720 Parthenogenic Oocyte Activation

09/573,044 Use of embryonic stem cells as nuclear donors during nuclear transfer and use of said techniques to produce chimeric and transgenic animals.

6,194,202 Parthenogenic Oocyte Activation

6,077,710  Parthenogenic Oocyte Activation

6,107,543  Culture of Totipotent Embryonic Inner Cells Mass Cells and Production of Bovine
Animals

Field of Use

The Field shall exclude applications involving the use of cells in the treatment of tumors where the primary use of the cells is the destruction or reduction of tumors and does not involve regeneration of tissue or organ function.

License Grant

Subject to Canadian Licensor's right to acquire a co-exclusive interest as provided in this Agreement, Licensor grants to the Company an exclusive, royalty-bearing, worldwide license, with the right to grant sublicenses to the Company Sublicensees, under the Cell Technology and Patent Rights to make, have made, use, have used, sell, have sold, and manipulate Products in the Field and to perform the Services in the Field.

License Property

Cell Technology shall mean all know-how, data, biological materials, inventions and other proprietary information and technology relating to the manufacture, sale, use or manipulation of Cells within the Field provided to the Company prior to the Effective Date.

Cells shall mean in vitro generated, growth factor responsive neural stem cells to the extent claimed in the Patent Rights and shall include all progeny and derivatives of such stem cells (including Progenitor Cells and their progeny and Stem Cells and their progeny) and Cell shall mean one of such cells. An in vitro generated growth factor responsive neural stem cell shall include a neural stem cell, or its derivatives or progeny, which exhibits one or more of the following characteristics

(a) is dependent on the presence of a growth factor for survival and viability, or (b) proliferates or differentiates due to the presence of a growth factor, whether alone or in combination with another biologically active molecule; and

An EGF-responsive neuronal stem cell includes
a neuronal stem cell, or its derivatives or progeny, which exhibits one or more of the following characteristics

(a) is dependent on the presence of EGF for survival and viability, or (b) proliferates or differentiates due to the presence of EGF, whether alone or in combination with another biologically active molecule all to the extent claimed or allowed under the Patent Rights.

Product shall mean any product utilizing the Cells and the manufacture, use, or sale of which, but for the license granted to the Company hereunder, would infringe any claim of the Patent
Rights.

Services shall mean any use of the Cells or the Cell Technology to perform a service for a third party for compensation, where such use would, but for the license granted to the Company hereunder, infringe any claim of the Patent Rights.

Field of Use

Field shall mean the use of Cells for Transplantation only, including, without limitation

(a) for Cell Replacement Therapy; (b) for the purposes of Transplantation anywhere in the human body for the treatment or prevention of human disease, injury, or disorder; (c) for augmenting the function of endogenous cells by Transplantation or Cell Replacement Therapy; and (d) for the purposes of transplantation therapy in general (e.g., Transplantation of the Cells for delivery of one or more Agents).