Royalty Report: Drugs, Autoimmune, Disease – Collection: 279346

License Grant

Licensor grants to the Swiss Licensee a sole and exclusive, even as to Licensor, worldwide right and license under the Licensor Patents and Licensor Know-How to make, have made, use, offer for sale, sell and import Licensed Products in the Field.

Licensor grants a nonexclusive, nontransferable. limited right to use the Licensor trademark.

License Property

Licensor owns or controls patents and know-how related to a series of proprietary compounds which act as purine nucleoside phosphorylase inhibitors (PNP Inhibitors), including the compound known as –X-4208.

Compound means the PNP Inhibitor known as –X-4208.

Licensed Product means any and all pharmaceutical products containing Compound.

Field of Use

The Field means the prevention or treatment of Autoimmune Indications and Transplantation Indications.

Autoimmune Indications means all indications that involve pathogenic consequences, including tissue injury, produced by autoantibodies or autoreactive T lymphocytes interacting with self epitopes, i.e., autoantigens.

Transplantation Indications means all indications that involve the suppression of rejection of transplanted organs, bone marrow or other tissue, including, without limitation, solid organ transplantation (including tolerance induction and xenotransplantation), bone marrow transplantation, graft versus host disease and cell transplantation.

BCX-4208 is for the prevention of acute rejection in transplantation and for the treatment of autoimmune diseases.

License Grant

Licensor hereby grants to the Swiss Licensee a co-exclusive license (together with Licensor), under the Licensor Technology, to develop Licensed Products in the Collaborative Fields with respect to the U.S. Territory and the European Union, in accordance with the Asthma Development Plan and Transplant Development Plan, and to import and use Licensed Products for such purposes. The foregoing licenses include the right to perform Development outside the U.S. Territory and European Union in accordance with the Asthma Development Plan and Transplant Development Plan with respect to any Licensed Product, solely in order to obtain Regulatory Approval of such Licensed Product in the Collaborative Fields in the U.S. Territory or the European Union.

Licensor hereby grants to Licensee a co-exclusive (together with Licensor), non-transferable right to Promote and Detail Licensed Products in the Asthma Field in the U.S. Territory, in accordance with applicable law and the Asthma Commercialization Plan.

License Property

Licensed Product shall mean any pharmaceutical product having as an active ingredient Daclizumab, but excluding Nutley Dac.  Daclizumab means that certain humanized murine monoclonal antibody directed against the p55 component of IL-2R and given the generic name “Daclizumab” by the United States Adopted Names Council. Daclizumab does not include fragments of such antibody or any antibodies having a different amino acid sequence from such antibody.  IL-2R means the IL-2 receptor.

Licensor Technology means Licensor Know-How and Licensor Patents.

Know-How” means all inventions, discoveries, trade secrets, information, experience, data, formulas, procedures and results related to antibodies that bind to IL-2R, and improvements thereon, including any information regarding the physical, chemical, biological, toxicological, pharmacological, clinical, and veterinary data, dosage regimens, control assays and specifications of Licensed Products.

Licensor Patents means all patent applications owned or Controlled by Licensor or its Affiliates alone or with a Third Party (“Sole Licensor Patents”) and all Joint Licensee-Licensor Patents claiming Licensed Products or their manufacture or use in the Collaborative Fields, which are filed prior to or during the term of this Agreement in the U.S. or any foreign jurisdiction, including any addition, continuation, continuation-in-part or division thereof or any substitute application therefor; any patent issued with respect to such patent application, any reissue, extension or patent term extension of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent; and any other U.S. or foreign patent or inventor’s certificate covering Licensed Products in the Collaborative Fields.

Transplant Indications means all indications that involve the suppression of rejection of transplanted organs, bone marrow or other tissue, including, without limitation, solid organ transplantation (including tolerance induction and xenotransplantation), bone marrow transplantation, graft versus host disease and cell transplantation. In any event, if a given indication satisfies the criteria for both an Autoimmune Indication and a Transplant Indication, such indication shall be deemed a Transplant Indication and not an Autoimmune Indication, provided that an Autoimmune Indication shall not be deemed a Transplant Indication merely because it may cause the need for a transplant (e.g., Type I diabetes, even if it causes the need for an organ transplant).

Field of Use

Collaborative Field (i.e., used in the singular) shall refer either to the Asthma Field (unless and until the Asthma Field is excluded from the definition of Collaborative Field or the Transplant Field (unless and until the Transplant Field is excluded from· the definition of Collaborative Field.

Asthma Field means the treatment and/or prevention of asthma or other respiratory diseases.

Transplant Field means the Transplant Indications.

License Grant

This agreement is for development and commercialization of the clinical compound forodesine hydrochloride in markets across Europe, Asia and Australasia.

Licensor grants the Licensee of Bermuda an exclusive right and license in the Territory, with the right to sublicense, to Develop, make, have made, package and have packaged, use, promote, market, offer for sale, sell and import Licensed Products in the Field, under the Licensor Patents, Licensor Know-How and the Trademark.

Licensor grants during the Term of this Agreement a limited non-exclusive right to use the Licensor Logo on Promotional Literature in the Field in the Territory.

License Property

Licensor owns or controls patents and know-how related to a series of proprietary compounds which act as PNP Inhibitors, including the compound known as __X-1777.

Licensed Products means all pharmaceutical preparations in all dosage strengths, formulations and methods of administration that contain the Compound as its active ingredient, alone or in combination with another active ingredient.

Trademark means the trademark Fodosine or such other trademark approved by the JDC for use in connection with the Licensed Products, but excluding the Secondary Marks.

B-cell Acute Lymphoblastic Leukemia/lymphoma or B-ALL means a disease in which certain cells of the B lymphocytes or B-cells are malignant, and have populated the bone marrow.

B-CLL means B-type chronic lymphocytic leukemia.

B-NHL means a Non-Hodgkin’s lymphoma in which the malignant cells have characteristics predominantly of the B lineage.

Field of Use

Field means the treatment of all Cancerous and/or Pre-Cancerous States in humans, specifically for the treatment of certain T-cell and B-cell mediated diseases in the area of oncology.
Fodosineâ„¢ is a transition-state analog inhibitor of the target enzyme purine nucleoside phosphorylase (PNP). The drug is currently being studied in a number of clinical trials including a Phase IIa clinical trial in patients with T-cell leukemia.

License Grant

The Licensor of Sweden grants the exclusive, worldwide license under the Licensor IP and Licensors interest in the Jointly-Owned IP to Develop the Product and the exclusive license under the Licensor IP and Licensors interest in the Jointly-Owned IP to conduct Phase III Development, Finalize and Commercialize the Product in the Licensee Territory.

License Property

Licensor possesses rights to preclinical compounds for the treatment of transplant rejection and certain other autoimmune diseases.

The Product means any pharmaceutical formulation containing the Licensed Compound.

The Licensed Compound means a composition of matter that inhibits dihydroorotate dehydrogenase.

Field of Use

The licensed field is for all uses, other than the treatment, pallation or prevention of multiple sclerosis.

License Grant

Licensor grants to the Licensee, of Sweden, the exclusive, worldwide license under the Licensor IP and Licensors interest in the Jointly-Owned IP to Develop the Product,  the exclusive license under the Licensor IP and Licensors interest in the Jointly-Owned IP to conduct Phase III Development, Finalize and Commercialize and Manufacture the Product in the Licensee Territory.

License Property

Licensee possesses rights to preclinical compounds for the treatment of transplant rejection and certain other autoimmune diseases.

The Product means any pharmaceutical formulation containing the Licensed Compound.

The Licensed Compound means a composition of matter that inhibits dihydroorotate dehydrogenase.

Field of Use

The licensed field is for all uses, other than the treatment, pallation or prevention of multiple sclerosis.

License Grant

Licensor hereby grants to Licensee an exclusive perpetual sublicense to the Sublicensed Rights throughout the Territory, with the right to grant further sublicenses, to develop, promote, market, sell, make, have made, use, import, offer for sale, and commercialize the Sublicensed Products for the Sublicense Indications in the Field and Territory.

License Property

Licensor has received an exclusive worldwide license to certain rights arising from U.S. Provisional Patent Applications Serial No. 60/742,172, filed on December 2nd, 2005, entitled “Use of High-dose Oxazaphosphorine Drugs for Treating Immune Disorders”.

Technology relates to a patent-pending pharmaceutical treatment in late-stage development for the treatment of and prevention of transplant rejection including rejection following a bone marrow transplant. The pharmaceutical treatment uses an already-approved active pharmaceutical in a novel, ultra-high dose, pulsed administration.

Field of Use

“Field” shall mean the treatment of and prevention of transplant rejection including rejection following a bone marrow transplant and specifically shall not include indications for any other diseases or treatments.