Royalty Report: Drugs, Therapeutic, Pharmaceuticals – Collection: 25953

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.

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.

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

The Licensor hereby grants to the Company an exclusive, including to the exclusion of REVIMMUNE, 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 territory. Revimmune is a patent-pending pharmaceutical treatment in late-stage development for a variety of autoimmune diseases.

License Property

Revimmune uses an ultra-high intensity, short-course of an intravenous formulation of an approved drug (cyclophosphamide), in a new patent-pending method to reboot a patient’s immune system, thereby eliminating the autoimmunity, whereas current therapies including oral cyclophosphamide are used chronically to try to suppress the inflammation of autoimmunity. Based on long-term follow-up showing complete remissions, there is substantial evidence that Revimmune has the potential to cure cases of severe refractory autoimmune diseases such as aplastic anemia and myasthenia gravis. The Company's lead indication for Revimmune is multiple sclerosis (MS).

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.

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).

Licensor Technology means Licensor Know-How and Licensor Patents.

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.