Royalty Report: Drugs, Antibody, Disease – Collection: 227231

License Grant

Both parties enter into a joint cooperation.  Licensor grants to Swiss Licensee during the Agreement Period a world-wide license under its Know-How and Patent Rights, with the right to grant sublicenses, to make, have made, use and sell the Product(s) for use in the Field.   Said license shall be exclusive in the Exclusive Territories and shall be co-exclusive with Licensor in the Semi-exclusive Territories.  Licensee grants to Licensor during the Agreement Period a license under its Know-How and Patent Rights, to make, have made, use and sell the Product(s) for use in the Field.  Said license shall be limited to the Semi-exclusive Territories and shall be co-exclusive with Licensee in said Territories.

License Property

Product(s) shall mean the monoclonal antibodies owned or controlled by Licensor and Licensee for use in the Field, as described in the U.S. patent application(s) of Licensor and the U.K. patent application of Licensee, and fragments, toxin conjugates, antibody toxin chimeric constructs, humanized or reshaped antibodies derived from such monoclonal antibodies including such forms as are ready to be administered in humans.

Field of Use

Field shall mean anti-IgE antibody-based treatments in humans for IgE-mediated reactions, which most likely will include, but not be limited to, asthma and other diseases commonly termed allergies. The anti-IP treatment is based on mechanisms that are specifically directed towards reducing or eliminating circulating lgE and lgE producing B cells within the immune system. The scope of the Field and definition of Product(s) are not intended to include other areas of allergy research (including approaches such as peptides, or factors, including IL-4 and CD23) or development of antiidiotypic antibodies, which may be useful in modulating lgE production in humans.

The Parties are jointly developing an anti-IgE antibody product to treat allergies and allergic asthma.

License Grant

The Licensor and Swiss Licensee entered into the agreement to represent all aspects of the Original D&L Agreement related to Anti-IgE Antibodies and Anti-IgE Products in East Asia and the Rest of World and for the purpose of cooperating with respect to the development and commercialization of Anti-IgE Antibodies and Anti-IgE Products in East Asia and the Rest of World on the terms and conditions set forth.

License Property

The anti-IgE antibody-based treatments are for humans for IgE-mediated diseases.

Anti-IgE Product shall mean any human pharmaceutical formulation containing or comprising an Anti-IgE Antibody alone or in combination with other active or inactive ingredients, components or materials in the same formulation as the Anti-IgE Antibody.

Anti-IgE Products include, without limitation, Xolair, and Hu-901.
Anti-IgE Antibodies are to be Hu-901and E-25 but not limited to.

Hu-901 shall mean the Anti-IgE Antibody and/or Anti-IgE Product which is known by the Parties as of the Effective Date as “Hu-901”, “TNX-901,”
Xolair shall mean any product containing the Anti-IgE Antibody “E-25” or “omalizumab” (and modifications thereto resulting solely from changes in the Manufacturing process thereof), including without limitation, the Anti-IgE Product Approved by the FDA as of June 20, 2003.
E-25” shall mean the Anti-IgE Antibody and/or Anti-IgE Product.

Antibody shall mean any immunoglobulin protein (excluding any immunoadhesins), and any fragment, less than full-length antibody form (such as Fv, Fab, and F(ab’)2), single-chain antibody, or antibody conjugate bound to a toxin, label or other moiety which, in each case, includes one or more CDRs and is capable of immunospecific binding to an antigen, regardless of the method or means by which such immunoglobulin protein, fragment, less than full-length antibody form, single-chain antibody or antibody conjugate is produced.

Field of Use

Xolair is currently labeled for treatment of adults and adolescents (12 years of age and above) with moderate-to-severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. Xolair has been shown to decrease the incidence of asthma exacerbations in these patients. Clinical trials to test the safety and efficacy of Xolair to treat pediatric asthma patients have begun. Clinical trials to test the safety and efficacy of Xolair to treat peanut allergy patients are expected to begin during the second quarter of 2004.

License Grant

Licensor grants an exclusive, worldwide, license, with the right to sublicense, under the Licensor Technology to research, develop, make, have made, use, sell, offer for sale and import Licensed Products solely in the Antibody Targeting Technology Field.

Licensor grants an exclusive, worldwide, license, with the right to sublicense, under the HuMAb Technology and the Licensor Technology to research, develop, make, have made, use, sell, offer for sale and import
— Licensed Royalty-Bearing Products solely in the Antibody Targeting Technology Field, and,
— Anti-Mannose Products.

For Hybridoma Cell Lines; Research License, Licensor grants an exclusive, worldwide license, with the right to sublicense, under the HuMAb Technology to research, make, have made, transfer physical possession of, but not to sell, lease, offer to sell or lease, or otherwise transfer title to, the Hybridoma Cell Lines.

Licensor grants a non-exclusive, worldwide, license, with the right to sublicense, under the Research Patent to conduct research.

For Research Antibodies License, Licensor grants an exclusive, worldwide license, without the right to sublicense, under the HuMAb Technology and the Licensor Technology to use the Research Antibodies for the sole purpose of determining the antigen with respect to which each Research Antibody was raised.

Licensor, who has incorporated Licensee for business opportunities outside of Licensors core business, irrevocably, perpetually and forever assigns and conveys Licensors entire right, title and interest in and to each of the following Assigned Assets
— Antibody Targeting Patents;
— Antibody Targeting Know-How;
— Anti-Mannose Receptor HuMAb Antibodies;
— the Investigational New Drug Application # 11,508 and related governmental filings, and the right to make any future or foreign related filing on –X-1307;
— all quantities of Biological Materials, including those in the possession or control of counterparties to Assigned Contracts;
— all clinical inventories of –X-1307 in the possession or control of Licensor as of the Effective Date; and
— the agreements that are Assigned Contracts.

License Property

Licensor owns or otherwise controls certain technology, including certain patents and know-how, relating to the use of antibodies in connection with the research and development of vaccines.

Anti-Mannose Product shall mean any pharmaceutical composition or formulation incorporating an Anti-Mannose Receptor HuMAb Antibody.

HuMAb Mouse® shall mean any of Licensors immunizable transgenic mice containing unrearranged human immunoglobulin heavy and light chain transgenes, each inserted into mouse chromosomes, but excluding the Additional Mice. HuMAb Mice® shall mean more than one HuMAb Mouse.

The patents relate to Anti-FcyRI (CD64) antibodies.

Field of Use

The field of use is the Antibody Targeting Technology Field.  The Antibody Targeting Technology Field shall mean the use of an antibody, or fragment thereof, whereby the antibody or fragment serves as a targeting means with respect to an Antigen-Presenting Cell for the purpose of modulating an immune response in any of the following manners
—  an antibody or fragment chemically attached or genetically fused to an antigen (including an antigen that is an antibody, or fragment thereof, that encodes an idiotype antigen), whereby the antibody, or fragment thereof, serves as a targeting means for delivering such antigen to an Antigen-Presenting Cell for the purpose of eliciting an immune response,
— an antibody or fragment chemically attached or genetically fused to a toxin or radionuclide, whereby the antibody, or fragment thereof, serves as a targeting means for delivering such toxin or radionuclide to an Antigen-Presenting Cell for the purpose of decreasing, down-regulating or eliminating the activity of such Antigen-Presenting Cell,
— an antibody or fragment chemically attached or genetically fused to a cytokine, adjuvant, or other immuno-modulatory compound, whereby the antibody, or fragment thereof, serves as a targeting means for delivering such compound to an Antigen-Presenting Cell for the purpose of modulating the activity of such Antigen-Presenting Cell, and
— an antibody, or fragment thereof, alone, whereby the antibody or fragment binds to a particular antigen on the surface of an Antigen-Presenting Cell and through such binding modulates the activity of such Antigen-Presenting Cell.

License Grant

In 1990, we established a collaboration with Licensee to jointly develop anti-IgE antibodies to treat allergic diseases. In 1996, Licensee joined our collaboration with Licensee and we agreed to combine our respective anti-IgE development programs in a three-party collaboration. We and our collaboration partners selected Xolair as the lead product for development and commercialization.

License Property

Allergy drug TNX-901(Xolair) that changes the body's reaction to the histamine stimulants.

See article in other licensing detail that describes the current on-going legal debate surrounding this license.

Field of Use

The drug is a humanized anti-IgE monoclonal antibody designed to prevent symptoms of allergic asthma and allergic rhinitis.  Tests show it effective against peanut allergies.  In allergic diseases, the immune system responds to the antigen, or allergen in this case, by producing IgE. IgE binds to the surface of mast cells and basophils. These cells, which are found in tissue and also circulate in the blood, contain chemicals such as histamine and leukotrienes, which induce inflammation.

License Grant

Licensor, a nonprofit medical research facility, grants to Licensee an exclusive, worldwide license, without the right to sublicense, to Licensors Technology and under Licensors Patent Rights, to use the Licensed Process to make Licensed Product and to use and sell Licensed Product in the Field, provided, however, such exclusive license shall convert to a non-exclusive license either on the second anniversary of the Effective Date if Licensee has failed to sell Licensed Product prior to such anniversary or on the fifth anniversary of the Effective Date.

License Property

Licensor is engaged in fundamental scientific research including research relating to catalytic antibodies  and the expression of proteins in algae.  The Aldolase Catalytic Antibody 38C2 is an aldol addition reaction  catalyzing antibody or antibody fragment having an amino acid residue sequence equivalent to that of an aldol addition reaction catalyzing antibody or antibody fragment encoded by nucleic acid in or from hybridoma 38C2 described in U.S. Patent No. 5,733,757.  The term Licensed  Process is any process utilizing Scripps Technology to produce Aldolase Catalytic Antibody 38C2 in microalgae.

Field of Use

Licensor's patented Aldolase Catalytic Antibody 38C2 in microalgae is a genetically engineered aldolase catalytic antibody may have numerous potential applications in industrial synthesis, including the synthesis of certain anti-cancer compounds.

The Field is all applications or products except those adapted or intended for preventing,  treating,  mitigating or diagnosing a disease or condition in humans or vertebrate animals.

Licensee is engaged in the development of algal protein expression systems for the large-scale production of proteins useful in research and industrial enterprises.

License Grant

The Parties previously entered into an Amended and Restated Development and License Agreement governing the Parties’ joint development of anti-CD40 antibodies.

Licensor has discontinued the anti-CD40 antibody program thereunder, and Licensee now wishes to continue development of anti-CD40 antibodies on its own.

As of the effective date, the Prior Agreement is terminated in its entirety.

For the Grant under Licensor CD40 Know How,  Licensor grants a license under the Licensor CD40 Know How, to research, develop, make or have made, use, import, export, sell or offer for sale, Licensed Products in the Field in the Territory.

For the Grant under Licensor CD40 Patents, Licensor grants a license under the Licensor CD40 Patents, to research, develop, make or have made, use, import, export, sell or offer for sale, Licensed Products in the Field in the Territory.

For the Grant under Licensor Patents,  Licensor grants a license under the Licensor Patents, to research, develop, make or have made, use, import, export, sell or offer for sale, Licensed Products in the Field in the Territory.

For the Right to Use Materials and Technology,  Licensor grants a license under Licensors rights in the Materials and Technology, to use the Materials and Technology in the form supplied by Licensor to Licensee under this Agreement to research, develop, make or have made, use, import, export, sell or offer for sale, Licensed Products in the Field in the Territory.

License Property

Antibody means the humanized anti-CD40 monoclonal antibody designated by Licensor as PRO64553.

Anti-CD40 Antibody means any anti-CD40 antibody, including, without limitation, the Antibody, any variant, including, without limitation, humanized versions, or fragment, including, without limitation, single-chain versions, of any such anti-CD40 antibody, conjugates, including conjugates with radionuclides, toxins or other compounds, of any of the foregoing which, in each case, was developed by Licensor in its performance of the Prior Agreement.

Licensor CD40 Patents include, no. 60/280805 and no. 10/099,818 entitled Combination Therapy.

Licensed Product means any product containing an Anti-CD40 Antibody.

SGN-40 is a humanized monoclonal antibody that targets the CD40 antigen, which is highly expressed on most B lineage hematologic malignancies including non-Hodgkin's lymphoma, multiple myeloma and chronic lymphocytic leukemia. CD40 is also found on many types of solid tumors, including bladder, renal and ovarian cancer, and may play a role in immunologic diseases.

Field of Use

SGN-40 is a humanized monoclonal antibody currently in Phase I and Phase II clinical trials for multiple myeloma, chronic lymphocytic leukemia and non-Hodgkin's lymphoma.