Royalty Report: Drugs, cell therapy, Drug Discovery – Collection: 245925

License Grant

Licensor hereby grants Licensee a nonexclusive license under the Licensed Patent Rights and the Licensed Technology to develop, make, have made, and use Licensed Compounds ex vivo in the Territory for the purpose of developing, making, having made, using, having used, selling, having sold, offering for sale, importing, exporting and otherwise exploiting Products in the Field and in the Territory. The license shall include, without limitation, the right to (i) sell Products to purchasers and/or distributors in the Field and in the Territory and/or (ii) to collaborate with preclinical or clinical investigators in the Field and in the Territory provided such investigators are bound by the confidentiality provisions contained herein, and/or (iii) to sublicense to Affiliates of Licensee, to develop, make, have made, and use Licensed Compounds ex vivo in the Territory for the purpose of developing, making, having made, using, having used, selling, having sold, offering for sale, importing, exporting and otherwise exploiting Products in the Field and in the Territory, provided that such Affiliates will be bound by the terms and conditions contained herein and/or (iv) to sublicense to Third Parties to develop, make, have made, and use Licensed Compounds ex vivo in the Territory for the purpose of developing, making, having made, using, having used, selling, having sold, offering for sale, importing, exporting and otherwise exploiting Products in the Field and in the Territory for use in combination with Licenseel Technology, provided such Third Party sublicensee shall be identified to Licensor and be bound by the applicable terms and conditions as contained herein.

License Property

Licensed Patent Rights shall be as defined
5,869,451 – Peptides and compounds that bind to a receptor
6,121,238 – Peptides and compounds that bind to a receptor
6,251,864 – Peptides and compounds that bind to a receptor
6,083,913 – Peptides and compounds that bind to a thrombopoietin receptor
5,932,546 – Peptides and compounds that bind to the thrombopoietin receptor

Licensed Technology shall mean the technology, know-how, data, information and results relating to the synthesis and characterization of Licensed Compound to be supplied to Licenseel, as referred to Pre-Clinical Evaluation of Tpo Mimetic Peptides Index to Analysis, Biology, Formulation, Pharmacology, Synthesis and DMPK.

Licensed Compound shall mean any composition of matter which uses and/or comprises the AF13948, AF15705, GW350805 and/or GW395058 compounds.

Product shall mean any cellular therapy or gene therapy product developed or manufactured using a Licensed Compound, for which the use of the Licensed Compound would, but for the license granted hereunder, otherwise infringe a Valid Claim of the Licensed Patent Rights.

Thrombopoietin mimetics are drugs that considerably increase platelet production by stimulating the receptor for the hormone thrombopoietin.

Field of Use

Field shall mean ex vivo cell therapy and ex vivo gene therapy. The Field excludes parenteral or in vivo therapies, which are expressly reserved for Licensor or such third parties to whom such uses may be licensed by Licensor, provided that the Field shall include ex vivo and extra-corporeal uses where the primary intended activity of the Licensed Compound is ex vivo and any residuals thereof which may be introduced in vivo have no significant medical or therapeutic benefit. 'Extra-corporeal' means a process where a patients cells are extracted, processed and infused back into a subject by a device while the subject remains connected to the device.

The forms of TPO-mimetic is for use as a reagent in producing stem cell therapy products, including CB001.

CB001 is manufactured using one of Licensee's proprietary technologies which allows the isolation, purification and significant expansion of populations of stem cells. Licensee believe this proprietary technology will enable the production of well defined cellular products in therapeutically useful quantities. We are developing CB001 for use in bone marrow and other hematopoietic stem cell transplants.  CB001 has entered a Phase I/II clinical trial in older adolescents and adults.

License Grant

Licensor hereby grants to Licensee an exclusive (even as to Licensor) royalty-bearing, worldwide, perpetual, irrevocable right and license under the Licensed Patents and Licensed Know-How in the Territory to Develop, Commercialize, make, have made, use, have used, import, sell, offer for sale and have sold Licensed Compounds and Licensed Products in any and all fields in the Territory. Such license shall further include the right to grant sublicenses to Affiliates of Licensee and to Third Parties in accordance with the terms set forth. For the avoidance of doubt, Licensor shall retain rights under the Licensed Patents and Licensed Know-How to use LGD-4665 and other Licensed Compounds for its internal or partnered research and development purposes.

License Property

Promacta® / Revolade® is an oral thrombopoietin receptor agonist (TPO-RA).

LGD-4665 is a matter of oral thrombopoietin mimetic.

U. S. Patent #7314887 – Thrombopoietin activity modulating compounds and methods

Licensed Compound means any and all thrombopoietin mimetics Controlled by Licensor or its Affiliate during the Term of the Agreement including (a) that certain compound known as LGD-4665 with the molecular structure shown in this Agreement, and all formulations including intravenous formulations), salts, prodrugs, hydrates, solvates, polymorphs, enantiomers and isomers thereof; (b) any back-up compounds to LGD-4665 being developed by Licensor as of the Execution Date, as shown on, or incorporated by reference; and (c) any other thrombopoietin mimetic compounds that are Covered by the Licensed Patents. Notwithstanding the foregoing, for the purpose of this Agreement, an Affiliate shall not include any Third Party which acquires control over Licensor or over which Licensor acquires control after the Execution Date so long as such Third Party does not otherwise become involved in the conduct of Development or Commercialization of the Licensed Compounds.

Field of Use

Field of use is for the treatment of thrombocytopenia in pediatric patients 1 year and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.  A Bone marrow stimulant that can treat thrombocytopenia and aplastic anemia.

Thrombopoietin (THPO) also known as megakaryocyte growth and development factor (MGDF) is a protein that in humans is encoded by the THPO gene. Thrombopoietin is a glycoprotein hormone produced by the liver and kidney which regulates the production of platelets.

Severe aplastic anemia is a rare, life-threatening, acquired blood disorder in which a patients bone marrow fails to produce enough red blood cells, white blood cells, and platelets[5].

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

Licensor grants a sole and exclusive worldwide license or sublicense, as applicable, to the Licensor Technology for the CPS in the Field.

License Property

The patents include  Apparatus and Method for Maintaining  and Growing Biological Cells;  Methods of Increasing Rates of !n!ection by Directing Motion of Vectors;  Methods, Compositions and Apparatus for Cell Transfection; and, Methods, Compositions and Devices for Maintaining and Growing Human Stem and/or Hematopoietic Cells.

CPS means any system or device for substantially increasing, the number of cells, ex vivo, for human therapeutic uses, that may be configured in different component structures (such as described for the Automated CPS or the Manual CPS).

Licensed Product means the Automated CPS (both the Durables and the Disposables) as used for one or more specific Lymphoid Cell Applications.

Licensor is developing proprietary process technologies and devices for a range of cell therapy applications, including stem cell therapies and gene therapy. The lead product under development, the Licensors Cell Production System (the CPS) consists of a clinical cell culture system with disposable cassettes and reagents for use in the rapidly growing stem cell therapy market.

Field of Use

Field means Lymphoid Cell Applications.  Application means (a) the expansion of any Lymphoid Cell for one or more therapeutic uses, or (b) the transfection of a specific Lymphoid Cell type modified with a naturally occurring gene or a synthetic modification thereof for a specific therapeutic use. One Application is tumor infiltrating lymphocytes (TIL), such that TIL therapy for renal cell carcinoma and TIL therapy for breast cancer are part of the same Application.

Licensee, a competitor, along with others, are in advanced stages of development of technologies and products for use in stem cell therapy and other market applications currently being pursued by the Licensor.