Royalty Report: Drugs, Disease, Therapeutic – Collection: 26777

License Grant

Licensee may request that Licensor grant a nonexclusive worldwide license under the Licensor Patent Rights for up to two (2) additional antibodies under development by Licensee as of the date hereof.

License Property

The following are patents and patent applications (the Queen Patents) as of the Effective Date filed in certain countries in the world and licensed under the Agreement. The Queen Patents shall expressly include any foreign counterparts thereto filed by Licensor before or during the term of this Agreement.

1. European Patent number 0451216. Queen, Humanized Immunoglobulin and Their Production and Use.

2. U.S. patent divisional applications numbers 08/487,200, 08/477,728,08/474,040 of issued U.S. patent number 5,530,101, Queen, Improved Humanized Immunoglobulin.

3. Japan patent application number 4-503758, Queen, et al. Improved Humanized Immunoglobulin.

4. U.S. Patent No. 5,693,761, Queen, et al. Polynucleotides Encoding Improved Humanized Immunoglobulin, issued December 2, 1997.

5. U.S. Patent No. 5,693,762, Queen, et. a1. Humanized Immunoglobulin, issued December 2, 1997.

Field of Use

The technology a was used in the development of Xolair (omalizumab) for treating allergies and asthma by using anti-immunoglobulin E, or anti-IgE, antibodies capable of blocking IgE, a causative agent of the allergy pathway, thus preventing the onset of disease symptoms.   Xolair is a humanized monoclonal antibody that blocks IgE.  Some abiquitiy remains around the exact nature of the licensing agreement.

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

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 is granting a non-exclusive license under the Queen Patents for the purpose of conducting research, development and commercial activities on humanized antibodies directed against up to three Licensee Antigens.

For the License Grant, Licensor grants a nonexclusive, non-sublicensable, sublicense under the exclusive rights granted to Licensor herein to research, develop, make and use (but not to, have made, sell, or offer for sale) Licensed Biologic Products for Licensee internal research only.

Licenses to Licensee Under the Queen Patents
Licensor grants through the fifth anniversary of the Effective Date the right, upon written notice to Licensor, to receive licenses under the Licensor Antibody Humanization Patent Rights for the Licensee Antigens. Licensee shall identify each Licensee Antigen prior to IND Filing for the associated Licensed Queen Product. Each license shall be a nonexclusive, worldwide, transferable, license under the Licensor Antibody Humanization Patent Rights to make, have made, use, import, offer for sale and sell or otherwise dispose of Licensed Queen Product pursuant to a Licensor License Agreement to be executed by the Parties after such written notice.

License Property

Licensor has certain patents and patent applications concerning humanized antibodies and antibody humanization technology including certain patents and patent applications that are sometimes referred to as the Queen Patents.

Licensor Antigens shall mean an antigen selected by Licensee and approved by Licensor for the grant by Licensor to Licensee of a license to its Licensor Antibody Humanization Patent Rights, up to a limit of three antigens. Licensee shall identify each such Licensee Antigen after the Effective Date, but no later than the IND filing date for each associated Licensed Queen Product.

Licensed Queen Products shall mean any Antibody that binds to an Licensee Antigen whose development, manufacture, import, export, use, offer for sale or sale would infringe a Valid Queen Claim absent a license to one or more of the Queen Patents.

Field of Use

Therapeutic Field shall mean any human and/or animal use.

Diagnostic Field shall mean any use for the diagnosis, prognosis, or monitoring of a human disease or disorder.

License Grant

Pursuant to the master agreement, each Antigen will have its unique patent agreement.  Licensor grants to Licensee with respect to four (4) Antigens), the rights upon written notice to receive licenses under the Patent Rights for up to four (4) Antigens designated by Licensee.

Each license shall be a nonexclusive, worldwide license under the Licensors Patent Rights to make, have made, use, import, market, promote, offer for sale and sell or otherwise dispose of Antibodies pursuant to a Licensors License Agreements. The rights of Licensee shall include the right to grant sublicenses for Antibodies in accordance with the terms of the applicable License Agreement.

License Property

The licensed patents are for Humanized Immunoglobulins and Polynucleotides Encoding.

The Antigens are target molecules to which an Antibody specifically binds and includes all epitopes on that target molecule.

The licensed product means an Antibody with respect to which Licensee has either significant marketing rights or has done significant development, including without limitation created, humanized or conducted preclinical or clinical development, the manufacture, import, use, offer to sell or sale of which would infringe, if not licensed under this Agreement, also known as a Valid Claim.

Field of Use

Licensee identifies and develops therapeutic monoclonal antibodies to address significant unmet medical needs in the areas of immunology, infectious diseases and cancer.  Monoclonal antibodies are genetically engineered antibodies that target a specific foreign substance, or antigen.