Royalty Report: Drugs, Biotechnology, Ophthalmological – Collection: 787

License Grant

The Israeli Licensor hereby grants to the Israeli Licensee an exclusive, worldwide, royalty-bearing License, with the right to grant sublicenses to use, commercialize and/or exploit the Licensed Technology and the Licensed Materials for use in accordance with the applicable ethical guidelines, in any manner whatsoever and for any purpose or indication whatsoever, solely in the Field.

The Licensee shall have a research License, with the right to grant sublicenses solely in order to test internally or through sub-contractors up to three hESC Lines (HADC100, HADC102 and HADC106) and three Feeder Lines of the Materials prior to the selection of the Licensed Materials, which Research License shall expire upon the selection by the Company of the Licensed Materials, in respect of all other Materials.

License Property

“Licensed Materials” shall mean 1 (one) hESC line (the “hESC Line”) and 1 (one) cord feeder cell line (the “Feeder Line”) produced under current Good Manufacturing Practice (“cGMP”) conditions by or on behalf of HMO in compliance.

The hESC are being provided for use as a source material for a therapeutic product and Hadasit has no reason to believe that the hESC and feeder cell lines, if used by the Company in accordance with regulatory guidelines, are not consistent with such use.
One WCB of cord feeder cell line that will include a minimum of 40 vials (with a minimum of 5X106 per vial or equivalent) and additional 10 vials (with a minimum of 2.5×106 per vial) will be provided and shall be replication incompetent, meaning irradiated. The specified number of vials is before any characterization and safety testing
Five ampoules of 2 x 106 cells/ampoule of WCB cord feeders, which have not been irradiated or blocked by mitomycin C and are at passage earlier than ten (10) and are from the same MCB from which the irradiated WCB was developed will be provided. As part of the company’s OCS 2010 or OCS 2011 project or other funding source, the Company will cover all costs related to the preparation of the WCB from which these five ampoules will originate and the characterization of the WCB according to the recommendations of FDA consultant .

Patent Applications
249-00

Expired

US

31/12/2004

60/639,809

 

 

249-01

Expired

PCT

29/12/2005

IL2005/001397

6/7/2006

WO2006/070370

249-02

Pending

US

2/4/2007

11/730,560

 

 

 

Pending

US

29/12/2005

11/794,262

23/04/2009

2009-0104695

315-00

Expired

US

18/04/2007

60/907,818
 
 

 

315-01

Expired

PCT

27/04/2008

IL08/000556
 
WO2008/129554

 

315-04

Pending

US

27/04/2008

12/450,943

Field of Use

Field shall mean the development and exploitation of human stem-cell (“hSC”) (such as human embryonic SC (“hESC”) and induced pluripotent hSC (“iPS”) derived retinal pigment epithelial cells (“hESC-derived RPE Cells” and “hSC-derived RPE Cells”, as the case may be) solely for cell replacement therapy of conditions involving retinal degenerative diseases.

The Company is engaged in the development and commercialization of cell therapy applications for neurodegenerative diseases.

License Grant

Pursuant to the License Agreement, Licensor granted Licensee an exclusive, worldwide, royalty bearing license (with the right to grant sublicenses) in its intellectual property portfolio of materials and technology related to human stem cell derived photoreceptor cells and retinal pigment epithelial cells (the 'Licensed IP'), to use, commercialize and exploit any part thereof, in any manner whatsoever in the fields of the development and exploitation of (i) human stem cell derived photoreceptor cells, solely for use in cell therapy for the diagnosis, amelioration, prevention and treatment of eye disorders, and (ii) human stem cell derived retinal pigment epithelial cells, solely for use in cell therapy for the diagnosis, amelioration, prevention and treatment of eye disorders.

License Property

Intellectual property portfolio of materials and technology related to human stem cell derived photoreceptor cells and retinal pigment epithelial cells (the Licensed IP).

Field of Use

This agreement pertains to the medical industry relating to the fields of human stem cell therapy for the treatment of eye disorders.

License Grant

Licensor, a University's foundation, hereby grants Licensee and its Affiliates a world-wide, nonexclusive license under the Licensed Patents to make, further develop, use, import, and receive Licensed Materials for use in Internal Research.

Licensor hereby grants Licensee and its Affiliates a world-wide, nonexclusive license under the Licensed Patents and the Licensed Materials to develop, use, provide, and sell Services in the Licensed Field.

Licensor hereby grants Licensee and its Affiliates a world-wide, nonexclusive license under the Licensed Patents and the Licensed Materials to make, develop, use, sell, offer for sale, and import Research Products in the Licensed Field. The grants of this Section 2A shall only apply to those Affiliates for which Licensee has provided written notice to Licensor.  Any such identified Affiliates benefiting from such grants shall be bound by all obligations under this Agreement.

Limited Sublicenses – Licensor hereby grants Licensee the right to grant written limited sublicenses under the Licensed Patents to transfer, as applicable, Licensed Materials and/or Derivative Materials to Collaborators, Development Partners and Contract Service Providers, in accordance with the terms of this agreement.

License Property

Licensed Patents
Title – Countries – Issued Patents (U.S.)
Primate Embryonic Stem Cells – US; EP; CA; WO – 7,029,913 5,843,780 6,200,806.
Serum-Free Cultivation of Primate ES Cells – US; AU; BR; CA; CN; EP; HK; IL; IN; IS; JP; KR; MX; NO; NZ; SG – 7,217,569 7,005,252.
Master Human Stem Cell Lines for Gene Expression and Knockdown – US.
Methods Of Making Differentiated Cells From Primate Embryonic Stem Cells – US.
Differentiation of Stem Cells to Endoderm and Pancreatic Lineage – US.
Hematopoietic Differentiation of hESCs – AU; BR; CA; CN; EP; IL; IN; IS; JP; KR; LU; MX; NO; NZ; SE; SG; US; WO – 6,280,718 6,613,568.
Method of In Vitro Differentiation of Transplantable Neural Precursor Cells From Primate ES Cells – US – 6,887,706.
Endothelial Cells Derived from Primate ES Cells – AU; CA; CN; EP; HK; IL; IN; IS; JP; KR; LU; MX; NZ; SE; SG; US – 7,176,023.
Method of Making Embryoid Bodies from Primate ES Cells – US; AU; BR; CA; CN; EP; HK; IL; IN; IS; JP; KR; MX; NO; NZ; SG – 7,220,584 6,602,711.
Method of Forming Mesenchymal Stem Cells from ES Cells – AU; CA; EP; GB; IL; JP; KR; SG; US.
Directed Differentiation of hESCs into Mesenchymal/Stromal Cells – US.
In Vitro Differentiation of Hematopoietic Cells from Non-Human Primate and Human ES Cells – US; WO.
Generation of Clonal Mesenchymal Cells from hESCs in Serum-Free Conditions – US.
Cryopreservation of Pluripotent Stem Cells – US.
Defined Surfaces Of Self-Assembled Monolayers And Stem Cells – US.
Method of Reducing Cell Differentiation – US.
Improved Culture Of Stem Cells – US; WO.
Physiological Culture Conditions for ES Cells – US.
Feeder-Independent Extended Culture of ES Cells – AU; CA; CN; EP; GB; IL; IN; IS; JP; KR; NZ; SE; SG; US.
Cultivation of Primate ES Cells – AU; CA; CN; EP; GB; IL; JP; KR; SG; US.
Directed Genetic Modifications of Human Stem Cells – AU; CA; EP; GB; IL; KR; SG; US.
Method for Generating Primate Trophoblasts – AU; CA; CN; EP; HK; IL; IN; IS; JP; KR; MX; NZ; SG; US – 7,148,062.
Method of In Vitro Differentiation of Neural Stem Cells, Motor Neurons, and Dopamine Neurons from Primate ES Cells – US.
Method of Forming Dendritic Cells from ES Cells – AU; EP; GB; IL; JP; KR; SE; SG; US.
Differentiation of Pluripotent ES Cells – US.
Method of Generating Myelinating Oligodendrocytes from ES Cells – US.
A Method for Generating Keratinocytes and Keratinocyte Precursors from hESCs – US.

Licensed Materials means primate (including human) embryonic stem cells covered by the valid claims in the Licensed Patents and which meet the following conditions
(i) For embryonic stem cells created prior to April 26, 2005, the embryonic stem cell must be either (1) listed on the NIH Human Embryonic Stem Cell Registry at http//escr.nih.gov; or (2) derived from excess embryos created for the purpose' of in vitro fertilization with appropriate consent of the donor couple and not for the purpose of creating embryonic stem cells; or (3) derived from embryos created specifically for research purposes either by in vitro fertilization or by somatic cell nuclear transfer, for which the following additional conditions apply (a) the embryo may not have been maintained in vitro for more than 14 days; (b) the gamete donor(s) and somaticcell donor (if any) made the donation without payment beyond reimbursement for reasonable expenses associated with donation; (c) in the case of egg donation, the donor was fully informed of the risks to herself; (d) the gamete donor(s) and somatic cell donor (if any) were fully informed of the purposes to which their donated materials would be put; (e) the research could not be done equally weU using surplus IVF embryos originally created for reproductive purposes; (f) the research protocol, including gamete collection, somatic cell collection, embryo management and stem cell derivation is approved by an appropriate Institutional Review Board; and (g) protections are in place to prevent misappropriation of embryos created specifically for research.
(ii) For embryonic stem cells created from embryos created after April 26, 2005, the embryonic stem cells must be derived from embryos and under conditions in compliance with the Guidelines for Human Embryonic Stem Cell Research established by the National Research Council Institute of Medicine of the National Academies (the NAS Guidelines).
(iii) For embryonic stem cells created after April 26, 2005 from embryos generated prior to April 26, 2005, and which do not meet the NAS Guidelines, the embryonic stem cells must meet one of the conditions set forth in paragraph (i) above and be created using protocols substantially in compliance with the requirements of the NAS Guidelines.

Field of Use

Licensed Field shall be limited to the fields of (a) Research Products sold solely for an end-user's internal research purposes, and (b) Services rendered by Licensee and its Affiliates, and Services rendered by Development Partners as permitted by Section 2B(i)(c).

License Grant

Licensor hereby grants a royalty-bearing, worldwide, exclusive license, with the right to sublicense, to use the Patent Rights and Know-How to (a) research, develop, make, have made, use, sell, have sold, offer for sale, have offered for sale, import, have imported, export and have exported Licensed Products, (b) research, develop, use, practice, sell, have sold, offer for sale, have offered for sale, import, have imported, export and have exported Licensed Processes, and (c) develop, use, perform, sell, have sold, offer for sale, have offered for sale, import, have imported, export and have exported Licensed Services.

Company granted an exclusive license to use its “ACTCellerate” embryonic stem cell technology and a bank of over 140 diverse progenitor cell lines derived using that technology.

License Property

ACTCellerateâ„¢ is a recently discovered technology that allows the rapid isolation of novel highly purified embryonic progenitor cells. Embryonic progenitors are cells intermediate between embryonic stem cells and fully differentiated cells.  The progenitor cells are relatively easy to manufacture on a large scale and in a purified state, which may make it advantageous to work with these cells compared to the direct use of embryonic stem cells. Using the ACTCellerate platform technology over 140 distinguishable novel progenitor cell lines have already been created, scaled-up, and banked. These unique cell lines may possess the ability to become a wide array of products never before available to the medical community, with potential applications in research, drug discovery, and human regenerative stem cell therapy.  

The licensed rights include pending patent applications, knowledge and the existing bank of cell lines. The licence is exclusive and worldwide for all commercial purposes, including the development of research products, and therapeutic and diagnostic products for human and veterinary use.  Licensor has an option to reacquire rights to use the technology for the development of certain types of SCs for human therapeutic use in fields re-lated to its core business.

The technology allows the rapid isolation of novel, highly-purified embryonic progenitor cells. The progenitor cells are relatively easy to manufacture on a large scale and in a purified state, which may make it advantageous to work with these cells compared to the direct use of ESCs. These unique cell lines may have potential applications in research, drug discovery and human regenerative SC therapy.

Patent Rights
103080-069-WO1 (PCT/US06/13519, filed on 4-11-06) Novel uses of cells with Prenatal Patterns of prenatal gene expression, published as WO2007/058671
103080-071-P61 (USSN 60/791,400, filed on Apr. 11, 2006) Methods to accelerate the isolation of novel cell strains from pluripotent ST
103080-071-P66 (USSN 60/850,294, filed on Oct. 6, 2006), Methods to accelerate the isolation ov novel cell strains from pluripotent stem cells
103080-071-P01 (USSN 11/604,047, filed on Nov. 21, 2006), Methods to accelerate the isolation  of novel cell strains from pluripotent STE…
PCT is 103080-071-WO2 (PCT/US2006/45352, filed on Nov. 21, 2006), published as WO 2007/062198.