Royalty Report: Drugs, Cancer, Disease – Collection: 266792

License Grant

The Israeli Licensor, the technology transfer company of the University, grants an exclusive license, with the right to sublicense in two tiers, under All Patents to make, have made, use, sell, offer for sale and import the licensed products.

With this agreement, the Parties wish to resolve all existing and potential claims and outstanding obligations in connection with All Litigation Matters and desire to settle All Litigation Matters on the terms stated herein, without any admission of liability or wrongdoing, in order to avoid the time and expense of continuing to litigate All Litigation Matters.

License Property

The licensed products and related patents are for cetuximab _-C225 (Erbitux®), _-11F8 and all product incorporating the humanized antibody of  ___72000.

Cetuximab is an antibody for use in combination with irinotecan in the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer who are refractory to irinotecan-based chemotherapy and for use as a single-agent in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are intolerant to irinotecan-based chemotherapy.

11F8 is a fully-human monoclonal antibody which targets the human EGFR.

__-72000, also known as matuzumab, is a humanized EGFR-targeting monoclonal antibody.

Field of Use

Licensor is a biopharmaceutical company advancing oncology care by developing and commercializing a portfolio of targeted treatments designed to address the medical needs of patients with cancer.

License Grant

As part of the Agreements, the Company consented to Licensee' s subLicense of certain intellectual property rights relating to the development and commercialization of an anti-EGFR antibody to Takeda Pharmaceutical Company.  Licensee and Takeda signed an alliance in September 2005 for the development and commercialization of matuzumab (EMD-72000), a humanized EGFR -targeting monoclonal antibody.  Licensor expects to give written consent to subLicense in the first quarter of 2007.  In addition, Licensee agreed to increase its fixed royalty on net sales of Erbitux® outside the U.S. and Canada, effective July 1, 2006.  The Agreements also promote freedom to operate in the development and commercialization of matuzumab outside the United States and Canada and of IMC-11F8 (a fully-human EGFR -targeted IgG1 monoclonal antibody being developed by Licensor) within the United States and Canada through the granting of certain reciprocal rights, including the sharing of confidential technical information. This is in addition to the exclusive rights held by the Licensor to develop and commercialize IMC-11F8 outside of the United States and Canada. The Agreements do not extend to key intellectual property rights in the U.S. and Canada.

License Property

Erbitux® as a single agent, is indicated for the treatment of EGFR -expressing metastatic colorectal cancer after failure of both irinotecan- and oxaliplatin -based regimens. Erbitux®, as a single agent, is also indicated for the treatment of EGFR -expressing metastatic colorectal cancer in patients who are intolerant to irinotecan -based regimens.

Field of Use

The Field of Use apply to the healthcare industry relating to oncology care and treatment.

License Grant

With this settlement, the Parties are also amending the DLA in order to effectuate this Agreement.

With this amendment, Licensor shall consent in writing to a grant by Licensee of Germany to a Third Party  of a sub-license under the Radiotherapy Patent, the Chemotherapy Patent, each defined in the DLA and the Licensor Confidential Manufacturing Information, as defined in this July 2006 amendment to the DLA, to make, use and sell EMD•72000 which is a Licensee product,  within the Territory.

With this amendment Licensor grants an irrevocable, non- exclusive, worldwide license to use the Licensor Confidential Manufacturing Information to manufacture Licensee Products.

License Property

Licensor is a biopharmaceutical company whose focus is to advance oncology care by developing and commercializing a portfolio of targeted treatments designed to address the medical needs of patients with cancer. Licensor Confidential Manufacturing Information shall mean any and all Licensor information that is reasonably useful for the production, manufacture, processing, filling, finishing, packaging, labeling, shipping, and storage of Licensor Product.

Licensee Confidential Manufacturing Information shall mean any and all Licensee information that is reasonably useful for the production, manufacture, processing, filling, finishing. packaging, labeling, shipping, and storage of IMC-11F8.

The Licensee patents are titled Application entitled Pharmaceutical Preparation Comprising an Antibody Against the EGF Receptor;  Application entitled Lyophilised Preparation Comprising Antibodies Against the EGF Receptor;   Application entitled Liquid Formulation Comprising Cetuximab and Fatty Add Ester of Poiyoxyethylene Sorbitan;   Application entitled Highly Concentrated Liquid Formulations of Anti•EGFR Antibodies;  Application entitled Solid Forms of Anti-EGFR Antibodies;  Application entitled Treatment of Refractory Human Tumors with Epidermal Growth Factor Receptor Antagonists, assigned to ImClone Systems Incorporated;  Application entitled Treatment of Refractory Human Tumors with Epidermal Growth Factor Receptor;  Antagonists, assigned to ImClone Systems Incorporated;  Application entitled Method of Producing an Antibody to Epidermal Growth Factor Receptor, assigned to Licensor;  Application entitled Hypeiprolifera Disease with Epidermal Growth Factor Receptor Antagonists, Assigned to Licensor; Application entitled Crystal of EGFR Extracellular Domain and Ceruximab Fab Fragment. and Uses Thereof, co-assigned to Licensor and University of Pennsylvania;  and, Application entitled Method of Treating the Accumulation of Serous Fluids.

Field of Use

The field of use is Radiotherapy or Chemotherapy.

License Grant

This co-development and co-commercialization Agreement for Erbitux in Japan, the Licensee will distribute the product and record the sales for the collaboration. The terms of this Agreement provide that the Licensee will receive 50% of the profit/loss from sales in Japan, and the Licensor and Bristol-Myers Squibb will each receive 25%.

The sharing of profit/loss reflects the co-exclusive rights to Erbitux in Japan previously granted by the Licensor to the Licensee and Bristol-Myers Squibb. Cetuximab Erbitux is a chimeric mouse/human monoclonal antibody used to treat metastatic colorectal cancer and head and neck cancer.

Field of Use

The rights granted apply to the medical industry.

License Grant

The German Licensor grants the Swiss Licensee a worldwide, exclusive, right and license, or sublicense, with the right to grant sublicenses, under the Licensed Technology to make, have made, use, offer for sale, sell, and import the Product in the Field in the Territory.

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

License Property

Licensor is developing a pharmaceutical product comprising a human antibody of IgG-1 subtype binding to EpCAM.

The patents include Novel Method for the Production of anti-human Antigen Receptors and Uses thereof, and, Anti-EpCAM Immunoglobulins.

Decatumumab (MT201) is a recombinant human monoclonal antibody with a binding specificity to epithelial cell adhesion molecule (Ep-CAM). Adecatumumab (MT201) is being evaluated in two European Phase 2 clinical trials, one in patients with prostate cancer, and one in patients with metastatic breast cancer.

Field of Use

The Field means the treatment of human diseases, disorders and conditions.

License Grant

With this agreement, the French Licensee will receive an exclusive worldwide license to develop, manufacture and commercialize MM-121. Licensor will retain potential co-promotion rights in the United States.

Licensor grants the French Licensee an exclusive right and license, with the right to grant sub licenses, under Licensed Technology and Licensed Patent Rights, including Licensors rights to Joint Technology and Joint Patent Rights, to research, have researched, develop, have developed, make, have made, use, offer for sale, sell, have sold, import and export Collaboration Compounds and Licensed Products in the Field in the Territory.

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

License Property

Licensor has rights to a monoclonal antibody, known as MM-121, with binding affinity to the ErbB3 protein.
MM-121 is a monoclonal antibody designed to block signaling of the ErbB3 receptor, a member of the epidermal growth factor (EGF) receptor family.  

The Collaboration Compound means MM121, or, any antibody fragment of MM-121, including any Fab, F(ab)2, Fv, and scFv fragments, or the primary molecular target of which is ErbB3.  ErbB3, also known as HER3, is a transmembrane receptor belonging to the epidermal growth factor (EGF) receptor family.

MM-121 is currently in Phase 1 clinical testing.

Licensed Technology means the Diagnostic Technology and the Therapeutic Technology.

Field of Use

Field means all human and veterinary fields of use, including therapeutic, prophylactic and diagnostic uses in all possible indications.

MM-121 a genetically engineered antibody designed to block a receptor on cells known as ErbB3. That’s thought to be an important new target for cancer drugs, because it’s a member of the epidermal growth factor receptor family of proteins, which are known to amplify cell proliferation that can give rise to out-of-control tumors.

The ErbB3 receptor is a novel target known to be a key mediator of signaling in the ErbB pathway (also known as the EGFR or HER pathway) – a signaling network that impacts a broad array of cancers. By targeting ErbB3, MM-121 is believed to have a broad application across cancer as both a monotherapy and in combination with other therapeutics.

License Grant

This amendment, between the Licensor of China and Licensee of Bermuda, clarifies term and modifies sublicensing royalties.  Under the original agreement, the Licensor of China assigns and transfers to the SubLicensee of Bermuda all of Licensors rights and obligations under the License Agreement.   The original agreement has conditional exclusivity.

License Property

The original agreement  licensed property is MM-398 is a highly stable nanoliposomal formulation of irinotecan.

The FDA has approved MM-398 (irinotecan liposome injection; Onivyde) in combination with 5-fluorouracil (5-FU) and leucovorin as a treatment for patients with metastatic pancreatic cancer following prior administration of a gemcitabine-based regimen.

Field of Use

The original agreement Field means all human and veterinary fields of use, including therapeutic, prophylactic, palliative and diagnostic uses in all possible indications.  MM-398, or irinotecan, is use with chemotherapy treatments.

License Grant

The Parties entered this agreement to develop and commercialize ficlatuzumab.  The non-opting out party shall have sole decision-making authority with respect to further development and commercialization of ficlatuzumab.

Licensor granted the perpetual, non-exclusive rights to certain intellectual property, including diagnostic data related to VeriStrat, with respect to the development and commercialization of ficlatuzumab.

License Property

Ficlatuzumab is a hepatocyte growth factor (HGF) inhibitory antibody.

VeriStrat®, is Licensor’s proprietary companion diagnostic test.

A retrospective exploratory analysis uses VeriStrat®, a commercially available serum protein test, to identify patients most likely to benefit from the addition of ficlatuzumab, AVEO’s HGF inhibitory antibody, to epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor (TKI) therapy in a randomized Phase 2 study of ficlatuzumab and gefitinib (IRESSA®) in previously untreated Asian subjects with non-small cell lung cancer (NSCLC).

Field of Use

The field of use is the treatment of non-small cell lung cancer in poor prognosis patients.  Licensee is a biopharmaceutical company.

License Grant

Licensor have entered into an exclusive collaboration and license agreement with Chinese Licensee involving three immuno-oncology (I-O) programs from Licensor's pipeline of product candidates: margetuximab, MGD013 and an undisclosed multi-specific Trident molecule in preclinical development.

License Property

Margetuximab is an immune-optimized anti-HER2 monoclonal antibody currently being evaluated in Phase 3 metastatic breast cancer with anticipated topline. Margetuximab is an Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2, oncoprotein. HER2 is expressed by tumor cells in breast, gastric, and other solid tumor cancers, making it a key marker for biologic therapy.

MGD013 is a first-in-class bispecific DART molecule designed to provide coordinate blockade of two immune checkpoint molecules expressed on T cells, PD-1 and LAG-3, for the potential treatment of a range of solid tumors and hematological malignancies.

Field of Use

Licensee is a Shanghai-based innovative biopharmaceutical company focused on bringing transformative medicines for cancer.