Royalty Report: Drugs, Pharmaceuticals, Therapeutic – Collection: 717

License Grant

This amends that certain Patent Licensing Master Agreement dated September 25, 1998 as amended by Amendment No. 1 to the Patent Licensing Master Agreement dated September 18, 2003 for on sales of this humanized antibody products.

Licensor may deny Licensee's request for a license grant only if Licensor has previously granted an exclusive or co-exclusive license or an unexpired option for an exclusive or co-exclusive license with respect to Antibodies to the identical Antigen or is then actively engaged in bona fide negotiations for such an exclusive or co-exclusive license or option for an exclusive or co-exclusive license.

License Property

Avastin, Herceptin, Lucentis, Xolair and Raptiva.

Avastin is approved for Metastatic colorectal cancer (mCRC).

Herceptin is a monoclonal antibody that interferes with the HER2/neu receptor. Its main use is to treat certain breast cancers.

Lucentis is a monoclonal antibody fragment (Fab) derived from the same parent mouse antibody as bevacizumab (Avastin). LUCENTIS® is a prescription medicine for the treatment of patients with wet age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), and diabetic macular edema (DME).

Raptiva is a formerly available medication designed to treat autoimmune diseases, originally marketed to treat psoriasis.

Xolair is a humanized antibody used to reduce sensitivity to inhaled or ingested allergens, especially in the control of moderate to severe allergic asthma which does not respond to high doses of corticosteroids.

Field of Use

The rights granted apply with respect to Antibodies to the identical Antigen or is then actively engaged in.

License Grant

Licensor owns rights to the Patents related to humanized antibodies and methods of making and manufacturing humanized antibodies. Licensee develops, produces, uses, and/or sells a number of humanized antibody products, including, without limitation, Xolair, Raptiva, Herceptin, and Avastin.

Licensor and Licensee are parties to that certain Patent Licensing Master Agreement dated September 25, 1998, as amended by Amendment No. 1 To The Patent Licensing Master Agreement dated September 18, 2003 and Amendment No. 2 To The Patent Licensing Master Agreement pertaining to licensing of rights to their respective patents, and are parties to that certain License Agreement dated November 3, 1998 as amended by Amendment No. 1 To The Herceptin License Agreement of even date herewith under which Licensor licensed the Patents to Licensee for the Herceptin antibody product.

Licensee further agrees and stipulates that each of the claims of any present or future issued patents within the Patent Family is valid and enforceable, subject to the Proviso.

Licensee agrees, covenants, represents, and warrants that it will not (i) knowingly or intentionally file or otherwise initiate or participate in a lawsuit, arbitration proceeding, United States Patent And Trademark Office interference or other legal proceeding in the United States in which Licensee alleges or seeks a determination that one or more claims of an issued patent within the Patent Family is invalid or unenforceable.

Field of Use

Avastin is approved for Metastatic colorectal cancer (mCRC).

Herceptin is a monoclonal antibody that interferes with the HER2/neu receptor. Its main use is to treat certain breast cancers.

Raptiva is a formerly available medication designed to treat autoimmune diseases, originally marketed to treat psoriasis.

Xolair is a humanized antibody used to reduce sensitivity to inhaled or ingested allergens, especially in the control of moderate to severe allergic asthma which does not respond to high doses of corticosteroids.

License Grant

Licensor entered into a settlement agreement with Licensee which resolves all outstanding legal disputes between the parties, including the Nevada litigation and the arbitration proceedings with Licensee related to the audit of royalties on sales.

Under the terms of the agreement, effective retroactively to August 15, 2013, Licensee will pay a fixed royalty rate on worldwide sales of Avastin®, Herceptin®, Lucentis®, Xolair®, Kadcyla® and Perjeta®, as compared to the previous tiered royalty rate in the U.S and the fixed rate on all ex-U.S based manufactured and sold licensed products

License Property

Pursuant to the agreement, Licensee confirms that Avastin, Herceptin, Lucentis, Xolair and Perjeta are licensed products as defined in the relevant license agreements between the parties, and further agree that Kadcyla is a licensed product. Licensee will pay these royalties on all worldwide sales of Avastin, Herceptin, Xolair, Perjeta and Kadcyla occurring on or before December 31, 2015. With respect to Lucentis, Licensee will owe no royalties on U.S. sales occurring after June 30, 2013, and will pay a royalty on all ex-U.S. sales occurring on or before December 28, 2014.

Field of Use

The rights granted apply to the pharmaceutical market relating to drugs in the healthcare industry.

License Grant

The Licensor entered into a License and collaboration Agreement with Licensee for the global development and commercialization outside the United States of EYLEA® (aflibercept) Injection.

Pursuant to the Amendment, the Licensor consented to the commercialization of EYLEA in Japan pursuant to a Co-Promotion and Distribution Agreement, which was executed concurrently with the execution of the Amendment.

License Property

Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.

EYLEA® (aflibercept) Injection is indicated for the treatment of patients with neovascular (Wet) Age-related Macular Degeneration (AMD).

License Grant

Licensor hereby grants to each Licensee a non-exclusive, worldwide license under the Licensed Patents for the Term of this Agreement to make, have made, use, offer for sale, sell, import, and export Licensed Product in the Field in the Territory.

License Property

“Licensed Product” shall mean the protein aflibercept, whether sold under the trade name Zaltrap or any other name, and any pharmaceutical formulation of the protein aflibercept with one or more excipients, in each case that is intended for use in the Field in the Territory.
ZALTRAP is an FDA-approved anti-cancer medicine given in combination with a chemotherapy regimen called FOLFIRI (foal-feer-ee) to treat colorectal cancer that has spread.

IP relates to the Davis-Smyth patents, and certain other patents, in all indications for human use other than the prevention or treatment of eye diseases and eye disorders through administration to the eye. Under the terms of the ZALTRAP Agreement, payments are required to be made to licensor based on sales of ZALTRAP in the United States and of ZALTRAP that is manufactured in the United States and sold outside the United States through May 7, 2016.

The partner commenced sales of ZALTRAP (ziv-aflibercept) Injection for Intravenous Infusion, in combination with 5-fluorouracil, leucovorin, irinotecan ('FOLFIRI'), for patients with metastatic colorectal cancer (“mCRC”) that is resistant to or has progressed following an oxaliplatin-containing regimen, in the United States in the third quarter of 2012 and in certain European and other countries in the first quarter of 2013.

The licensee and partner globally collaborate on the development and commercialization of ZALTRAP.

Licensed Patents
.S. Patent No. 5,952,199
U.S. Patent No. 6,100,071
U.S. Patent No. 6,383,486
U.S. Patent No. 6,897,294
U.S. Patent No. 7,771,721
U.S. Patent No. 8,268,313
U.S. Patent No. 8,268,591
U.S. Patent No. 8,273,353
U.S. Patent Application No. 08/643,839
U.S. Patent No. 7,998,931
U.S. Patent No. 8,007,799
U.S. Patent No. 8,287,873
U.S. Patent Application No. 12/002,605

Field of Use

“Field” shall mean and be limited to the prevention or treatment of any disease or condition in a human through the administration of Licensed Product, excluding only the Ocular Field. As used herein, “Ocular Field” shall mean the prevention or treatment of eye diseases and eye disorders in a human through the administration of Licensed Product to the eye (including, but not limited to, the prevention or treatment of age-related macular degeneration, central retinal vein occlusion, diabetic macular edema, and/or myopic choroidal neovascularization in a human).

License Grant

The Licensor hereby granted to the Licensee a royalty-bearing, exclusive worldwide right and license, with the right to grant sublicenses, for Cytokine Modulator (CM) as a therapeutic drug containing a single active pharmaceutical ingredient or two or more active pharmaceutical ingredients where no component of the CM is tacrolimus, cyclosporine, ISAtx24, Rapamycin (Sirolimus), Pimecrolimus, Everolimus, another calcineurin inhibitor or a corticosteroid. Subject to the terms and conditions of this Agreement, the Licensor shall grant the Licensee a right of reference to the Licensor Generated Data to Exploit Licensed Products in the Licensed Combination Field.

License Property

BOE Disease means the following diseases Wet Age-related Macular Degeneration; Dry Age-related Macular Degeneration; Posterior uveitis (chorioentinitis); Retinitis Pigmentosa; Retinal Vein Occlusion; Retinal detachment; Retinal Artery Occlusion; Proliferative diabetic retinopathy; Post-operative inflammation; Persistant Macular Edema; Neovascular diseases involving the retina or uveal tract such as neovascular glaucoma, neovascularization following a combined vitrectomy and lensectomy, neovascularization of the optic nerve, and neovascularization due to penetration of the eye or contusive ocular injury; Inflammation due to ocular trauma; Open-angle glaucoma; Closed-angle glaucoma; Exudative macular edema; Diabetic Retinopathy; Diabetic Macular Edema; Cystoid macular edema; Chronic posterior uveitis; Allograft rejection; Behcet's syndrome; Chorioiditis; Crystalline retinopathy; Optic neurtitis; Proliferative sickle cell retinopathy; Proliferative vitreoretinopathy; Retinopathy of prematurity; Vitreitis; Temporal arteritis; Fuchs' Dystrophy; Dacryocystitis; Giant cell arteritis; Sympathetic ophthalmia; Pars planitis; Pan Uveitis; and all other similar diseases as agreed to by the Parties.

Field of Use

Licensee has certain proprietary in vitro and in vivo models of ophthalmic diseases, and clinical expertise in developing ophthalmic therapeutics.  Collaboration Combination Field means use of a Collaboration Combination by Local Administration to treat the diseases.

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.