Royalty Report: Drugs, Arthritis, Disease – Collection: 286023

License Grant

The Licensor of England grants a right and license to develop, make, have made, use, offer for sale, sell, have sold, import and export Licensed Products for use in the Field in the Territory.  

The license s exclusive or non-exclusive on a patent by patent basis.

License Property

Licensor has a product, known as Cxx-870, which contains a recombinant humanized pegylated Fab’ antibody fragment which binds to TNF alpha, or Tumor Necrosis Factor? alpha.

Licensed Product means any product that contains or comprises an Antibody, or any chemically modified Antibody, which recognizes TNF alpha. For the avoidance of doubt, Licensed Product shall not include non-Antibody inhibitors of TNF alpha.

The patents are titled Multichain Polypeptides or Proteins and Processes: for their Production;
Recombinant Antibody; Humanized Antibodies; Protein Expression System;  Process for obtaining Antibodies; Monovalent Antibody Fragments;  and, Biological Products.

Field of Use

Field means the prevention, treatment, diagnosis or control of all diseases or conditions in humans or animals; provided, however, that with respect to CDP-571, the Field shall not include the prevention, treatment, diagnosis or control of any diseases or conditions other than rheumatoid arthritis.

IBD Indication means the prevention, treatment or control of Crohn’s Disease and/or ulcerative colitis in humans and/or animals.

RA Indication means the prevention, treatment or control of rheumatoid arthritis in humans.

License Grant

The Licensor Parties have agreed to grant certain rights under their respective patents to Licensee to permit Licensee to commercialize such IL-I Trap product and certain follow-on IL-I Trap products.

Both Licensor Parties grant to Licensee and its Affiliates a non-exclusive license, with a limited right to grant sublicenses, under their respective Licensed Patent Rights to make, have made, use, sell, offer for sale and import Licensed Products in the Field of Use anywhere in the Territory.

License Property

The Licensed Product(s) shall mean a molecule, or gene encoding a molecule, comprising all or an interleukin-1 binding portion of the amino acid sequence for interleukin-1 receptor Type 1 or interleukin-1 receptor Type 2 ( or, in each case, any polypeptide having an amino acid sequence at least 90% identical to all or a portion thereof which itself binds interleukin-1, and, all or an interleukin-I binding portion of the amino acid sequence of a second molecule (exclusive of interleukin-I receptor Type 1, interleukin-1 receptor Type 2 or antibodies which bind interleukin-I, including variants and fragments thereof which bind interleukin-1) that itself binds interleukin-1, or together with any such interleukin-1 binding ammo acid seinquence referred to, participates in the binding of interleukin-1 (including, without limitation, the interleukin-1 receptor accessory protein or a portion thereof (or any polypeptide having an amino acid sequence at least 90% identical to all or a portion thereof)); wherein the molecule is capable of binding of interleukin-1.

Interleukin-1 is a Protein-based drug candidate designed to bind the interleukin-1 (called IL1) cytokine and prevent its interaction with cell surface receptors. IL1 is thought to play a major role in rheumatoid arthritis and other inflammatory diseases.

Field of Use

The Field of Use shall mean all uses of Licensed Product(s).

License Grant

The Company entered a joint venture with Chinese Licensor to further develop and commercialize ONS-3010 with Licensor in the agreed countries.

License Property

The Phase I ONS-3010 trial demonstrated pharmacokinetic (PK) bioequivalence on the primary and secondary endpoints for the biosimilar candidate and the US and EU originator product (Humira).

ONS-3010 is a subcutaneous injectable mAb that binds to tumor necrosis factor alpha, or TNFa. TNFa belongs to a family of pro-inflammatory cytokines, or soluble protein mediators, that are key initiators of immune-mediated inflammation in many different diseases, such as rheumatoid arthritis, psoriatic arthritis, psoriasis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis. Several biologic agents, including Humira, have been developed to inhibit the inflammatory activity of TNFs in the context of these diseases and are collectively referred to as the anti-TNF class of therapeutics.

Humira, the reference product for ONS-3010, is a subcutaneous injectable mAb that binds to tumor necrosis factor alpha, or TNFa. TNFa belongs to a family of pro-inflammatory cytokines, or soluble protein mediators, that are key initiators of immune-mediated inflammation in many different diseases, such as rheumatoid arthritis, psoriatic arthritis, psoriasis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis. Several biologic agents, including Humira, have been developed to inhibit the inflammatory activity of TNFs in the context of these diseases and are collectively referred to as the anti-TNF class of therapeutics.

Field of Use

Humira is used to treat many inflammatory conditions in adults, such as ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and a skin condition called hidradenitis suppurativa.

License Grant

The Licensor of China grants the right to use all intellectual properties generated during the development of the Therapeutic Product under this agreement.

License Property

The developments will be related to Anti-TNFalpha therapies.

Tumor necrosis factor a (TNF) is one of the key chemical messengers that help regulate the inflammatory process and plays an important role in the underlying mechanisms of conditions such as rheumatoid arthritis, psoriasis, and many other inflammatory disorders. When the body produces too much TNF, it overwhelms the immune system’s ability to control inflammation of the joints or of psoriasis-affected skin areas. The TNF inhibitors are molecules that disrupt the TNF function by blocking the binding of TNF to the TNF receptors. Blockage of these receptors can result in a significant reduction in inflammatory activity and reduce symptoms, inhibit the progression of structural damage, and improve physical function in patients with moderate to severe rheumatoid arthritis.

Field of Use

The field is for commercializing anti-TNFalpha monoclonal antibodies to be used as therapeutic agents.

License Grant

The Swiss Licensor grants to the UK Licensee a worldwide, exclusive license, including the right to grant sublicenses, under the Licensed Patents, for Licensee and its Affiliates to research, develop, make, have made, use, offer for sale, sell, have sold and import Licensed Products for any and all uses in the Field in the Territory.

License Property

The nti-IL6R antibodies marketed or in development for a range of inflammatory conditions including rheumatoid arthritis. The Licensee intends to explore the development of NI-1201 in Non-alcoholic Steato hepatitis (NASH), diabetes and other life threatening inflammatory diseases.

Field of Use

Field means any and all uses including all therapeutic uses.  Licensed IP includes the nti-IL6R antibodies for a range of inflammatory conditions including rheumatoid arthritis.

Licensee desires to obtain an exclusive license to patents owned or controlled by Licensor, a sublicense to certain patents licensed from Bristol-Myers Squibb Company (“BMS”), along with any associated know-how, biologic materials, clinical data or other technology relating to IL-6 receptor monoclonal antibodies (identified as NI-1201), and their use in order to research, develop and commercialize products and services.

License Grant

The Japanese Licensor grants a non-exclusive license under the Patent Rights to make, have made, import, have imported, use, sell, have sold, offer for sale and otherwise exploit the Licensed Products in the Territory for use in the Field.

License Property

Licensor owns certain Patent Rights relating to tumor necrosis factor alpha (TNF).

Licensed Product means any product which is within the scope of an issued Valid Claim or was within the scope of an issued Valid Claim.

Field of Use

The field means all gene therapy (In vivo  and Ex vivo) applications.

TNFerade produces tumor necrosis factor-alpha (TNF-alpha), a protein with a well-documented anticancer effect, directly at the site of disease through an injection into the tumor.

License Grant

Licensor hereby grants to Licensee an exclusive license, with the right to grant sublicenses under Licensor's Technology to research, develop, make, have made, use, sell, offer for sale, export and import Licensor's Antibodies and Products in the Field in the Territory.
The license grants rights to all Licensor's mAbs (monoclonal antibodies) in the field of influenza discovered from their CellSpot platform.

License Property

The license provides Licensee with three fully human mAbs that bind, neutralize and protect animals from all strains of H1, H3 and B influenza, and that will also cross bind, neutralize and protect animals from all other seasonal or pandemic influenza strains that may arise (including H5N1 and H7N9).

“Antibody” means any antibody or protein comprising at least one CDR portion thereof (including multi-specific antibodies, single chain antibodies, antibody fragments, domain antibodies and conjugated antibodies) and/or similar binding protein (such as an adnectin), whether human, humanized, chimeric, murine, synthetic or from any other source.

Field of Use

“Field” means all uses for the diagnosis, treatment or prevention of influenza.

License Grant

Licensor grants to the United Kingdom Licensee a non-exclusive license, without the right to sublicense, in the territory in the field of use and under the Patent Rights to research, develop, make, have made, use, sell, have sold, offer for sale, have offered for sale, import, and export Licensed Products, and research, develop, use, and practice Licensed Processes only for the purposes of manufacturing or having manufactured the Licensed Products.

Licensor grants a non-exclusive license, without the right to sublicense, in the Territory to conduct preclinical research and/or pre-Phase II clinical trials ( or the equivalent of pre-Phase II clinical trials in the U.S. or other countries) involving the use of Licensed Products in indications outside of the Field of Use.

License Property

The Licensed Product means the first three (3) short consensus repeat protein domains of human complement receptor type 1 (CRI), derivatized to include a myristoyl peptide, having Licensees designation -070 or any successor product of such -070 which is an optimization or derivative of -070, the development, manufacture, use, sale, offer for sale, importation or distribution.

Field of Use

The field of use means the treatment of rheumatoid arthritis.

License Grant

Licensor grants the Licensee of China an exclusive, non-transferable, perpetual license in the field of Therapeutic usage in order to develop and conduct clinical trials to achieve Chinese FDA (SFDA) approval of the rabbit anti-TNFalpha monoclonal antibody compounds. Under these rights, Licensor grants both the manufacturing and distribution rights of anti-TNFalpha monoclonal antibody therapeutics covered under the intellectual properties rights owned by Licensor.

License Property

Licensor utilizes a proprietary and patented technology in the development and production of Rabbit Monoclonal Antibodies (RabMAb technology).

Licensor has developed a panel of 50 novel anti-TNFalpha rabbit monoclonal antibodies that are highly potent compared with Remicade and Humira in in-vitro assays.

Licensor will provide Humanized Rabbit anti-TNFalpha monoclonal antibodies to Licensee.

Field of Use

The field is for commercializing anti-TNFalpha monoclonal antibodies to be used as therapeutic agents.  Anti-TNFalpha therapies are effective in treating Rheumatoid arthritis, Psoriasis, Psoriatic arthritis, Ankylosing spondylis and Crohns diseases.

License Grant

The Belgium Licensor entered into an exclusive license agreement with Japanese Licensee for the development and commercialization of anti-TNF alpha Nanobody, ozoralizumab, for the treatment of RA in Japan. The Licensee will be responsible for the development, registration and commercialization of ozoralizumab.

License Property

Ozoralizumab is a TNF alpha blocker being developed for the treatment of auto-immune disorders with an initial focus on RA.

Field of Use

The Japanese Licensee is planning to initiate a Phase III trial in RA patients in Japan with ozoralizumab in 2018.

License Grant

Licensor grants the German Licensee a non-exclusive, worldwide license, under the Licensor Licensed Patents to Exploit Licensed Products other than BiTE Products and BiTE Research Products.

Licensor grants an exclusive, worldwide, perpetual, irrevocable, non-terminable, license, with the right to grant and authorize the grant of sublicenses, under the Licensor Licensed Patents to Exploit any BiTE Products and BiTE Research Products.

License Property

Licensed Product means any SCA Product, Non-Human SCA Product, Research Product, Industrial SCA Product, BiTE Product, or BiTE Research Product, the composition, manufacture, use of which is claimed by one or more Valid Claims of the Consolidated Patent Portfolio.

This additional amendment added patent 5,223,409, entitled Directed evolution of novel binding proteins.

BiTE Product means any composition or formulation consisting of, containing or comprising a bi-specific Single Chain Antibody expressed as a single polypeptide chain, binding to T-cells for the diagnosis, prophylaxis or treatment of human or non-human diseases or conditions, but excluding any BiTE Research Product.

Diagnostic SCA (Single Chain Antibodies) Product means an SCA Product that is under development, approved or used for the diagnosis of human diseases or conditions.

Licensee Pipeline Product means any Licensed Product, other than a BiTE Product or BiTE Research Product, as to which Licensee obtains or retains Commercialization Rights, whether exclusive or co-exclusive, in one or more Major Market Countries, or Licensee or any of its Affiliates has filed or will file an IND in its own name.

Industrial SCA Product means any composition or formulation consisting of, containing or comprising one or more Single Chain Antibodies intended for any use other than for research or the diagnosis, prophylaxis, or treatment of disease or conditions in humans and other animals.

Licensor Pipeline Product means any Licensed Product as to which Licensor obtains or retains Commercialization Rights, whether exclusive or co-exclusive, in one or more Major Market Countries, or Licensor or its Affiliates has filed or will file an IND in its own name.

Non-Human SCA Product means any composition or formulation consisting of, containing or comprising one or more Single Chain Antibodies under development, approved or used for the diagnosis, prophylaxis or treatment of non-human diseases or conditions, but excluding any BiTE Products.

Research Product means a product consisting of, containing or comprising one or more Single Chain Antibodies used for research purposes and not intended, under development or used for the diagnosis, prophylaxis or treatment of human or non-human diseases or conditions, but excluding any BiTE Research Product.

SCA Product means any composition or formulation consisting of, containing or comprising one or more Single Chain Antibodies that is under development, approved or used for the diagnosis, prophylaxis or treatment of human diseases or conditions, but excluding any BiTE Product.

Field of Use

The field of use is Products for Radioimmunoguided Surgery™ (RIGS®), in which a radiolabelled Single Chain Antibody is administered to a cancer patient; time elapses for preferential concentration of the radiolabelled Single Chain Antibody in neoplastic tissue and decrease of background radioactivity in the patient; and such preferentially concentrated radiolabelled Single Chain Antibody is detected within a surgical operative field by a detector probe placed in juxtaposition with tissue suspected of containing said radiolabelled Single Chain Antibody, and,

Reagents and kits in the research market for production and cloning of genes encoding Single Chain Antibodies and their fusions in a filamentous bacteriophage-derived vector system, and for expression and screening of Single Chain Antibodies fused with the minor coat protein or attachment or adsorption protein of filamentous bacteriophage, and,

Single Chain Antibodies fused with, or for the assay or purification of, Tumor Necrosis Factor alpha (TNF-a) or Lymphotoxin, and, Single Chain Antibodies that bind to OP-1 or related proteins.

License Grant

The English parties agree to a collaboration for the further development, manufacture and commercialization of the Product initially for the treatment of rheumatoid arthritis (‘RA’) and Crohn’s disease in humans and for the treatment of any other agreed indications in the Field.  The co-exclusive collaboration includes the right to appoint any third party including but not limited to affiliated companies as distributors, except for Japan where Licensee shall have the right to appoint sub-licensees.

License Property

Product means Licensor’s anti-TNFµ compound known as CDP-870 in any formulation and indication.

Field of Use

The licence is exclusive for rheumatoid arthritis and other indications, excluding Crohn's disease.

License Grant

The German Licensor grants to a non-exclusive, worldwide, license under the Licensors Licensed Patents to Exploit Licensed Products other than BiTE Products.

License Property

Licensed Product means any SCA Product, Non-Human SCA Product, Research Product, Industrial SCA Product, BiTE Product, or BiTE Research Product, the composition, manufacture, use of which is claimed by one or more Valid Claims of the Consolidated Patent Portfolio.

BiTE Product means any composition or formulation consisting of, containing or comprising a bi-specific Single Chain Antibody expressed as a single polypeptide chain, binding to T-cells for the diagnosis, prophylaxis or treatment of human or non-human diseases or conditions, but excluding any BiTE Research Product.

Diagnostic SCA (Single Chain Antibodies) Product means an SCA Product that is under development, approved or used for the diagnosis of human diseases or conditions.

Licensee Pipeline Product means any Licensed Product, other than a BiTE Product or BiTE Research Product, as to which Licensee obtains or retains Commercialization Rights, whether exclusive or co-exclusive, in one or more Major Market Countries, or Licensee or any of its Affiliates has filed or will file an IND in its own name.

Industrial SCA Product means any composition or formulation consisting of, containing or comprising one or more Single Chain Antibodies intended for any use other than for research or the diagnosis, prophylaxis, or treatment of disease or conditions in humans and other animals.

Licensor Pipeline Product means any Licensed Product as to which Licensor obtains or retains Commercialization Rights, whether exclusive or co-exclusive, in one or more Major Market Countries, or Licensor or its Affiliates has filed or will file an IND in its own name.

Non-Human SCA Product means any composition or formulation consisting of, containing or comprising one or more Single Chain Antibodies under development, approved or used for the diagnosis, prophylaxis or treatment of non-human diseases or conditions, but excluding any BiTE Products.

Research Product means a product consisting of, containing or comprising one or more Single Chain Antibodies used for research purposes and not intended, under development or used for the diagnosis, prophylaxis or treatment of human or non-human diseases or conditions, but excluding any BiTE Research Product.

SCA Product means any composition or formulation consisting of, containing or comprising one or more Single Chain Antibodies that is under development, approved or used for the diagnosis, prophylaxis or treatment of human diseases or conditions, but excluding any BiTE Product.

Field of Use

The field of use is Products for Radioimmunoguided Surgery™ (RIGS®), in which a radiolabelled Single Chain Antibody is administered to a cancer patient; time elapses for preferential concentration of the radiolabelled Single Chain Antibody in neoplastic tissue and decrease of background radioactivity in the patient; and such preferentially concentrated radiolabelled Single Chain Antibody is detected within a surgical operative field by a detector probe placed in juxtaposition with tissue suspected of containing said radiolabelled Single Chain Antibody, and,

Reagents and kits in the research market for production and cloning of genes encoding Single Chain Antibodies and their fusions in a filamentous bacteriophage-derived vector system, and for expression and screening of Single Chain Antibodies fused with the minor coat protein or attachment or adsorption protein of filamentous bacteriophage, and,

Single Chain Antibodies fused with, or for the assay or purification of, Tumor Necrosis Factor alpha (TNF-a) or Lymphotoxin, and,

Single Chain Antibodies that bind to OP-1 or related proteins.