Royalty Report: Medical, Packaging & Containers, Device – Collection: 6088

License Grant

Licensor hereby grants to Licensee a non-exclusive, non-transferable, royalty-bearing license under the Licensed Patents in the Territory.

License Property

The Licensor holds certain patents relating to the storage, expansion and use of hematopoietic stem cells.

a. 'Collection' or 'Collected' means accumulation of or accumulated Cord Blood in a container.

b. 'Cord Blood' means blood or any blood components (including without limitation stem cells) collected from a human umbilical cord and/or placenta.

c. 'Cryopreservative' means an agent capable of preserving at very low temperatures.

d. 'Cryopreserve' means to preserve a material, such as Cord Blood or Stem Cells, by freezing.

e. 'Cryopreserved Blood' means (i) frozen Cord Blood, (ii) frozen and thawed Cord Blood or (iii) any other composition which would, but for this Agreement, infringe one or more claims of the Licensed Patents, in all three instances with or without a Cryopreservative.

g. 'Expanded Stem Cells' means Stem Cells, expanded from Cryopreserved Blood, or Cryopreserved after expansion.

i. 'Licensed Patents' means U.S. Patents Nos. 5,004,681, 5,192,553, 6,461,645, 6,569,427 and 6,605,275 and all patents that are related to any or all of those patents through priority or otherwise, directly or indirectly, including but not limited to, continuations, continuations in part, divisions, reissues and reexaminations thereof, and shall further include any other.

j. 'Licensed Process' means any process for the Collection, storage or use of Cord Blood that would, but for this Agreement, infringe one or more claims of Licensed Patents.

k. 'Modified Stem Cells' means Stem Cells, modified from Cryopreserved Blood, or Cryopreserved after modification.

Field of Use

The Licensee has the right to collects, processes and stores cord blood utilizing the Licensor's technology and processes covered by its patents for so long as the patents may remain in effect.

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.

License Grant

The Licensor entered into a License Agreement with the Licensee to establish and market the Licensor's U-Cord business in Germany with the option to expand the Licensed territory to include Italy, Spain and France.

License Property

The Licensor is engaged in cellular processing and cryogenic storage, with a current focus on the collection and preservation of umbilical cord (U-Cord®) blood stem cells for family use.

Field of Use

The Licensee has been providing families an opportunity to cryogenically preserve their newborn's umbilical cord blood stem cells in a safe and secure environment. This service is called U-Cord.

License Grant

The Licensor and Licensee executed an amendment to the definitive License and royalty Agreement. The amendment changes the royalties payable to the Licensor for all cord blood collection, processing and storage revenues generated after September 1, 2006.

License Property

The Licensor is engaged in cellular processing and cryogenic storage, with a current focus on the collection and preservation of umbilical cord (U-Cord®) blood stem cells for family use. The Licensor believes it is the world’s largest family cord blood stem cell bank in terms of the number of specimens preserved.

Field of Use

The rights granted apply to the medical industry.

License Grant

The exclusive License is to market the Company’s U-Cord® program.

License Property

The Company is engaged in cellular processing and cryogenic storage, with a current focus on the collection and preservation of umbilical cord (U-Cord®) blood stem cells for family use. The Company believes it is the world’s largest family cord blood stem cell bank in terms of the number of specimens preserved.

Field of Use

The rights granted apply in the area of medical technology relating to stem cells.

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

Licensor grants to Chinese Licensee an exclusive, perpetual license to use Licensor's Proprietary Know-how, to manufacture, produce, market, distribute, sell and use the Contract Services.

License Property

Licensor’s Proprietary Know-how shall mean all of Licensor's know-how related to the collection, processing, testing and preservation of stem cells from umbilical cord blood or other sources.

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 entered into a definitive License and Royalty Agreement with the India Licensee to establish and market its C’elleSM menstrual stem cell preservation program in India and optionally, into the countries of Bangladesh, Nepal, Pakistan and Sri Lanka.  In consideration for the up-front License fee, the Licensor transferred its technology, know-how and quality systems to the Licensee. Once the Licensee has processed 10,000 specimens, the parties have agreed to renegotiate the royalty fee on collection, processing and storage revenues.

License Property

The C'elle(SM) service empowers women to collect and cryopreserve menstrual flow containing undifferentiated adult stem cells for future utilization by the donor or possibly their first-degree relatives in a manner similar to umbilical cord blood stem cells.

License Grant

The Licensor grants the Licensee an exclusive licence to use, process, test and store the Materials (umbilical cord tissue samples) and Mesenchymal Stem Cells;  produce Licensed Product, including the creation of Derivatives and Progeny from Materials;  supply Licensed Product to third parties and to provide services in relation to such Licensed Product to third parties; and sub-licence its rights to Affiliates and to third party service providers.

License Property

The procurement of Mesenchymal Stem Cells derived from umbilical cord blood or placenta to be used for research purposes.  Materials are only for use in humans or for human application.

Field of Use

Cord Blood/Tissue, derived cells, progeny or derivative may be supplied and used in research projects if conducted in accordance with certain conditions.

License is for the methodology for producing clinical-grade pooled human umbilical cord derived mesenchymal stem/stromal cells (“HucMSC”) at industrial scale.

License Grant

Purchaser shall retain exclusive ownership rights in, and exclusive rights to exploit, U.S. Patent No. 5,190,556 included in the Assets (the “Patent”) and any other patents included in the Assets or otherwise arising out of the Assets (the “Additional Patents”), and have no obligation to grant the Company any rights therein.

License Property

CordguardTM – disposable umbilical blood sampling system.  Designed to minimize clinian exposure to cord blood while cutting the umbilical cord and collecting vital newborn blood samples.

License Grant

The Option grants the exclusive option to obtain an exclusive license to certain of University’s patent rights to make, have made, use, import, offer for sale, sell and otherwise commercially exploit certain licensed products and to practice certain licensed processes, and the exclusive right to use certain regulatory data and technical information in connection with such licensed patent rights, in the treatment, prevention, cure, reduction, mitigation or other management of diseases in humans, except, with regard to certain patent rights, in certain excluded fields of use and in certain territories, as well as a limited license to make, have made or use certain products, processes, data and information for the purpose of evaluating the market potential for such products and processes in the designated field of use, subject to University’s reserved rights to practice the licensed rights for all research, public service, internal (including clinical) and/or educational purposes. Pursuant to the Option, the terms of any such license are to include the terms.

The University grants an exclusive option to obtain
(a) an exclusive worldwide license under Patent Rights B to make, have made, use, import, offer for sale, sell and otherwise commercially exploit Licensed Products and to practice Licensed Processes, and the exclusive right to use regulatory data and technical information in connection with such licensed patent rights, in the Field of use and Territory; and
(b) an exclusive license under Patent Rights A to make, have made, use, import, offer for sale, sell and otherwise commercially exploit Licensed Products and to practice Licensed Processes, and the exclusive right to use Regulatory Data and Technical Information in connection with such licensed patent rights, in the Field of Use and Territory except for the Excluded fields of uses in the Excluded Territory.

License Property

The Option is for patent rights, regulatory data, and proprietary processes related to cord blood, cord tissue and DUOC-01.

Patent Rights Group (A) include

•
METHODS OF TREATING BRAIN INJURY USING CORD BLOOD OR A COMPONENT THEREOF,

•
COMPOSITIONS AND METHODS OF THE TREATMENT OF DEMYLINATING CONDITIONS,
        â€¢
METHODS FOR THE TREATMENT OF AUTISM SPECTRUM DISORDERS,
Patent Rights Group (B) include

•
METHODS OF TREATING CEREBRAL PALSY USING HIGH DOSE ALLOGENEIC UMBILICAL CORD BLOOD,

•
METHODS OF TREATING CEREBRAL PALSY AND HYPOXIC-ISCHEMIC ENCEPHALOPATHY USING HUMAN UMBILICAL CORD TISSUE-DERIVED MESENCHYMAL STROMAL CELLS,
       •
METHODS FOR THE TREATMENT OF AUTISM SPECTRUM DISORDERS USING HUMAN UMBILICAL CORD TISSUE-DERIVED MESENCHYMAL STROMAL CELLS,
       •        COMPOSITIONS AND METHODS FOR THE TREATMENT OF DEMYELINATING CONDITIONS
       •
COMPOSITIONS COMPRISING MESESCHYMAL STROMAL CELLS FOR THE TREATMENT OF VIRAL INFECTIONS

Field of Use

The Field of Use for the proprietary processes related to cord blood and cord tissue means the treatment, prevention, cure, reduction, mitigation or other management of any and all diseases and conditions in humans.  The Excluded Fields of Use means autologous specific therapeutics for autism, cerebral palsy and stroke.

Option agreement brings novel cord blood and birthing tissue based cellular therapeutics to the clinic.

The company services include the cryopreservation of umbilical cord blood and cord tissue. The company has also patented a method for processing endometrial stem cells from menstrual blood.

License Grant

The Company acquired an exclusive license (and a right to sub-license) to the technology and know-how relating to an isolation and commercial scale expansion methodology of GMP grade human umbilical cord mesenchymal stem/stromal cells (“MSC”).

License Property

Mesenchymal stem cells (“HucMSC”) – a methodology for producing large numbers of clinical-grade pooled human umbilical cord.

Mesenchymal stem cells is for the medical research and biotech community that offers large volumes of high-quality, low passage human umbilical cord mesenchymal stem cells with minimal batch-to-batch variability.

Field of Use

This agreement pertains to the medical industry relating to stem cells.

License Grant

The Licensor shall train or arrange training for the SERVICE PROVIDER of China and other staff members of the SERVICE PROVIDER on the The Licensor's Stem Cell Services and SOPs.

License Property

The Licensor is a leader in adult stem cell collection, processing, cryopreservation and storage services and has rights to a range of proprietary stem cell technologies to be used in therapeutic applications.

The Service Provider is knowledgeable and experienced in the Asian healthcare market and wishes to obtain the exclusive rights to provide the Licensor's Stem Cell Services to a network of Centers.

“Stem Cell Collection” means that collection of human adult stem cells derived from peripheral blood and all related clinical procedures.

“Marks” means the “NEOSTEM” mark and name, and such other marks and names relating to the Business.

License Grant

University has granted to the Company an exclusive license to make, have made, use, import, offer for sale, sell and otherwise commercially exploit (with the right to sublicense) certain licensed products and to practice certain licensed processes, and the exclusive right to use certain regulatory data and technical information in connection with such licensed patent rights, in the treatment, prevention, cure, reduction, mitigation or other management of certain diseases in humans, except, with regard to certain patent rights, in certain excluded fields of use and in certain territories, subject to University’s reserved rights to practice the licensed rights for all research, public service, internal (including clinical) and/or educational purposes.

License Property

The licensed products and patent rights are related to cord blood and cord tissue.

Field of Use

Field of use is for the treatment, prevention, cure, reduction, mitigation or other management of certain diseases in humans relating to the cellular processing and cryogenic storage, with a current focus on the collection and preservation of umbilical cord blood stem cells for family use.

License Grant

Licensor grants an exclusive license under the Licensed Technology to research, develop, make, have made, import, have imported, use, have used, sell, have sold, offer for sale, have offered for sale, and otherwise exploit Licensed Products and Licensed Media throughout the Territory.

License Property

The Licensed Media means cryopreservation media covered by, or made by a process covered by, a Valid Claim included in the Licensed Patent Rights, or which utilizes the Technology or Improvements in material part.

The Licensed Product means any product, device, service or system in the Field which is covered by, or is made by a process covered by, a Valid Claim included in the Licensed Patent Rights, or which utilizes the Technology or Improvements in material part, but excluding Licensed Media.

The Licensed Technology means the Licensed Patent Rights, the Technology and the Improvements.  The patent is for Cryopreservation and cell culture medium comprising less than 50 mM sodium ions and greater than 100 mM chlorine salt.

The Materials means the CJ panel of media, the CJ3 Freezing Medium and the CJ2 Thawing Medium.

Oocyte cryopreservation include using our product candidate to aid women (or couples) who require IVF, but who have ethical concerns about embryo cryopreservation and those individuals seeking donor oocytes, but for whom the logistics of coordinating a donor-recipient cycle present a challenge. We do not intend to use our oocyte product in connection with the use or harvesting of stem cells from embryos.

Field of Use

The field is human oocyte and human embryo cryopreservation with reference to use of the Materials, or any Improvements to the Materials.

License Grant

Licensor hereby grants to Licensee an exclusive royalty-bearing right and license in the Licensee Field throughout the Territory, with the right to grant sublicenses in accordance with the terms of this Agreement, under Licensors interest in the Licensor Development Technology and the Joint Development Technology to research, develop, have developed, use, manufacture, have manufactured, sell, offer for sale and have sold Licensee Products.

License Property

Oocyte cryopreservation, sometimes known as egg freezing, is a method of fertility preservation.

Covered Products shall mean any product or service related to the collection, processing and cryopreservation of human oocytes in any country in the Territory that meets any of the following criteria  (i) the development, manufacture or sale of any such product or any process undertaken in the provision of such services is covered by a Valid Claim of any Patent in such country included in the Hospital Patent Rights or any Patent in such country covering any portion of the Licensee Development Technology or Joint Development Technology (a Patented Covered Product); (ii) the development, manufacture or sale of any such product or any process undertaken in the provision of such services has, at any time, been covered by a Valid Claim of any Patent in such country included in the Hospital Patent Rights or any Patent in such country covering any portion of the Licensee Development Technology or Joint Development Technology, and all such Valid Claims have expired or been invalidated (an Expired Covered Product); or (iii) such product or service (a) is not described in clauses (i) or (ii) above and (b) is developed, manufactured, sold or provided using Licensee Development Technology or Joint Development Technology that is not described in or dominated by a Valid Claim of any Patent included in the Hospital Patent Rights or any Patent covering any portion of the Licensee Development Technology or Joint Development Technology (a  Development Technology Covered Product).

U.S. patent application serial number 09/798,327, filed March 12, 2001, entitled 'Microinjection of Cryoprotectants for Preservation of Oocytes.'
U.S. patent application serial number 09/859,105, filed May 16, 2001, entitled 'Microinjection of Cryoprotectants for Preservation of Oocytes'

Field of Use

Field shall mean the field of human oocyte cryopreservation.  Licensee Field shall mean the field of cryopreservation of mammalian cells other than human oocytes.  Oocyte cryopreservation, sometimes known as egg freezing, is a method of fertility preservation.

License Grant

The Agreement grants the patent rights. The contract grants Licensee access to proprietary process of expanding the master cell bank of Licensor.

License Property

9,803,176 – The Patent is titled Methods and compositions for the clinical derivation of an allogenic cell and therapeutic uses.

Field of Use

The field of use means transwell/co culture is for enhancing autologous cell stem cells.

The transwell migration assay is a commonly used test to study the migratory response of endothelial cells to angiogenic inducers or inhibitors. This assay is also known as the Boyden or modified Boyden chamber assay.