Royalty Report: Drugs, Cancer, Diagnostic – Collection: 319166

License Grant

Licensor grants the German Licensee a co-exclusive license or sublicense, as applicable, under the  Licensor Technology and Licensors interest in Joint Collaboration Technology to Develop the Product for Commercialization in the Field in the Territory, and, a co-exclusive right under the Licensor Technology, and Licensors interest in Joint Collaboration Technology and the Licensor Manufacturing Know-How to Manufacture the Product in the Field in the Territory, and, an exclusive, royalty-bearing license or sublicense, as applicable, under the Licensor Technology and Licensors interest in Joint Collaboration Technology to Commercialize the Product in the Field in the Territory.

This agreement includes a non-exclusive grant back from Licensee to Licensor.

License Property

Licensor has developed and is currently further developing a pharmaceutical product known as VELTUZUMAB.  VELTUZUMAB means humanized anti-CD20 antibody, also known as IMMU-106 and hA20.

The patent is for Anti-CD20 Antibodies and Fusion Proteins Thereof and Methods of Use.

Field of Use

Field means the treatment, palliation or prevention of non-cancer indications such as autoimmune and inflammatory diseases in humans using the Subcutaneous Formulation of the Product. For purposes of this Agreement, autoimmune and inflammatory diseases include, but are not limited to rheumatoid arthritis, systemic lupus erythematosus, Sj6grens syndrome, vasculitis, colitis, pancreatitis, idiopathic thrombocytopenic purpura, multiple sclerosis, myasthenia gravis, Graves disease and pemphigus vulgaris. For the avoidance of doubt, Field shall not include any oncology indications.

Licensee has significant experience in the development and commercialization of pharmaceutical products in the Territory.

License Grant

Licensor grants to Licensee, an affiliate, an exclusive, worldwide right and license, with the right to sublicense, under the Licensed Patents to research, Develop, manufacture, have manufactured, use, import and Commercialize and have Commercialized the Licensed Products, in and for the Field and to practice and have practiced any Licensed Processes, in and for the Field.

Effective immediately at the time Licensee is no longer deemed to be an Affiliate of Licensor, Licensor grants Licensee a non-exclusive license under Licensed rights in and to the Licensed Materials solely in support of the exercise of Licensees license rights.  Licensee shall not have the right and shall be prohibited from selling, transferring, or distributing the Licensed Materials to end users, except in the case where such end users are Licensor Affiliates or Sub licensees under this Agreement.

License Property

Licensor has rights to the Licensed Patents and Materials as granted by Dana Farber Cancer Institute.

Antibody means any antibody, any gene expressing such an antibody, any hybridoma producing such antibody, or any fragment, variant, derivative or construct thereof, or antibody fusion protein produced therefrom, including PEDgylated or multimeric versions thereof, whether polyclonal, monoclonal, multi-specific antibodies, e.g., bi-specific antibodies, human, humanized, chimeric, murine, synthetic, or from any other source, including without limitation, the full immunoglobin molecules (e.g. the IgG, IgM,IgE, IgA, and IgD molecules), and the antigen binding portions including Fab, Fab, F(ab)2, Fv, dAb, and CDR fragments, chimeric antibodies, diabodies, polypeptides, linear antibodies and single-chain antibodies (scFv) that contain any portion of an immunoglobulin that is sufficient to confer specific binding to an antigen.

The agreement is to develop and commercialize Licensor's fully human anti-PD-L1 and anti-GITR antibody research programs in the field of hematological malignancies.

Field of Use

The Field means all prophylactic, palliative, therapeutic or diagnostic uses in humans or animals for the prevention, diagnosis and treatment of hematological malignancies, including, without limitation, all Leukemias, Lymphomas, Multiple Myeloma and Waldentroms Macroglobulemia, but specifically excluding use in chimeric antigen receptor technology. Additionally, upon exercise of the Autoimmune Option, the Field shall include the prevention, diagnosis and treatment of Autoimmune Diseases.

Autoimmune Diseases means any disease which results from a loss of immune tolerance to self-antigens, including without limitation multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus, sjogren syndrome, celiac disease, Graves disease, myasthenia gravis, Type I diabetes, idiopathic thrombocytopenic purpura, pemphigus vulgaris, among others, including any presentation or manifestation thereof.

License Grant

Licensor grants under the Licensor Technology, Collaboration Inventions, and all patents claiming Collaboration Inventions, a co-exclusive license, together with Licensor, to develop in accordance with the Development Plan and use Licensed Products in the Asthma Field with respect to U.S. Territory and the European Union, a co-exclusive license, together with Licensor, to import Licensed Products in the Asthma Field into the European Union for such Development purposes, an exclusive license to import, offer for sale and sell Licensed Products in the Asthma Field in the U.S. Territory, and an exclusive license to make Licensed Products in the Asthma Field in the Territory.

For Additional Licenses to Collaboration Inventions, Licensor grants, under the Collaboration Inventions and all patents claiming Collaboration Inventions a co-exclusive license to develop, make, use, import, offer for sale and sell products, other than Licensed Products or Excluded Products, containing antibodies that bind to IL-2R in the Asthma Field in the Territory; and a co-exclusive license to develop, make, use, import, offer for sale, and sell Licensed Products and other products containing antibodies that bind to IL-2R, other than Excluded Products, in Licensee’s Exclusive Field in the Territory.

For the Trademark License, Licensor grants the co-exclusive right and license, together with Licensor to use the Zenapax Trademark solely in connection with the development, use, marketing, promotion, and detailing of Licensed Products in the Asthma Field in the U.S. Territory, the co-exclusive right and license, together with Licensor, to use the Zenapax Trademark solely in connection with the development of Licensed Products in the Asthma Field with respect to the European Union, and the exclusive right and license to use the Zenapax Trademark solely in connection with the offer for sale and sale of Licensed Products in the Asthma Field in the U.S. Territory.

License Property

Licensor currently markets a humanized antibody against the interleukin-2 (IL-2) receptor Daclizumab, under the trademark Zenapax®.

Autoimmune Indications or Al means all indications that involve pathogenic consequences, including tissue injury, produced by autoantibodies or autoreactive T lymphocytes interacting with self epitopes, i.e., autoantigens. Autoimmune Indications shall include, without limitation, asthma, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, juvenile rheumatoid arthritis, polymytosis, Type I diabetes, sarcoidosis, Sjogrens syndrome, chronic active nonpathogenic hepatitis, non-infectious uveitis (Behcets), aplastic anemia, regional nonpathogenic enteritis (including ulcerative colitis, Crohns Disease and inflammatory bowel disease), Kawasakis disease, post-infectious encephalitis, multiple sclerosis, and tropic spastic paraparesis.

Oaclizumab 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. Oaclizumab does not include fragments of such antibody or any antibodies having a different amino acid sequence from such antibody.

Licensed Product shall mean any pharmaceutical product having as an active ingredient Oaclizumab.

Zenapax Trademark means the trademark Zenapax®, and all trademark registrations and applications therefor, and all goodwill associated therewith.

Field of Use

Zenapax (daclizumab), a Phase II humanized monoclonal antibody for moderate to severe asthma.   “Asthma Field” means the treatment and/or prevention of asthma or other respiratory diseases.

The Exclusive Field means, with respect to Licensor, Licensors Exclusive Field and, with respect to Licensee, Licensees Exclusive Field.

Licensors Exclusive Field means the Transplant Indications, Notwithstanding the foregoing, upon the first to occur of the Reversion Effective Date or the Put Right Effective Date, the term Licensors Exclusive Field shall have no meaning.

Licensee’s Exclusive Field means the Autoimmune Indications, excluding the Asthma Field, Other Indications and, upon the first to occur of the Reversion Effective Date or the Put Right Effective Date, the Transplant Indications.