Royalty Report: Drugs, Antibody, Surgical – Collection: 279903

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

The Swiss Licensor hereby grants to Licensee, under the Licensor Technology, Licensor Inventions, and all patents claiming Licensor Inventions, (i) a co-exclusive license (together with Licensor) to develop in accordance with the Asthma Development Plan and Transplant Development Plan and use Licensed Products in the Collaborative Fields with respect to U.S. Territory and the European Union, (ii) a co-exclusive license (together with Licensor) to import Licensed Products in the Collaborative Fields into the European Union for such Development purposes, (iii) an exclusive license to import, offer for sale and sell Licensed Products in the Collaborative Fields in the U.S. Territory, and (iv) an exclusive license to make Licensed Products in the Collaborative Fields in the Territory.

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 Inventions means all inventions that (a) relate to or are useful with antibodies that bind the IL-2 receptor (IL-2R) and (b) are made during the term of this Agreement by employees of Licensor or persons contractually required to assign or license patent rights covering such inventions to Licensor, in the course of performing Licensor’s obligations, or exercising Licensor’s rights, under this Agreement.

Licensor Patents means all patent applications owned or Controlled by Licensor or its Affiliates (“Sole Licensor Patents”) alone or with a Third Party, and all Joint Licensor-Licensee 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.

Field of Use

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

Transplant Field means the Transplant Indications.

A 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.  Collaborative Fields shall be deemed to exclude the field (i.e., Asthma Field or Transplant Field) with respect to which the rights are so terminated.

License Grant

Licensor grants to Swiss Licensee and to Licensee’s Affiliates, during the Commercialization Term, the exclusive (even as to Licensor) right and license under the Licensor Know-How and Licensor Patents to (i) market, promote, and detail Nutley Dac in the Licensee Territory solely for use in Transplant Induction, and (ii) to sell and offer for sale Nutley Dac in the Licensee Territory under the Trademarks. In addition, Licensor grants to Licensee and to Licensee’s Affiliates, the nonexclusive right under the Licensor Know-How and Licensor Patents to make, have made, use and import Nutley Dac, but only to the extent reasonably necessary for Licensee to carry out its rights and obligations under this Second Amended and Restated Worldwide Agreement. Licensee may sublicense the rights and licenses granted to Licensee, subject to Licensor’s written consent, which consent Licensor may not unreasonably withhold. It shall be deemed reasonable for Licensor to withhold consent with respect to sublicense by Licensee of any of the rights or licenses to any other entity that is developing (in at least one Phase II clinical trial with directional human efficacy data), or marketing or selling in a Major Country any product for the treatment of any Autoimmune Indication. Notwithstanding the preceding sentence, Licensee and its Affiliates may use Third Party distributors in accordance with their customary practices. All sublicenses granted by Licensee or its Affiliates of the licenses set forth in this agreement shall automatically terminate at the end of the Commercialization Term.

License Property

Nutley Dac shall mean the FDA-approved form of Daclizumab manufactured at Licensee’s Nutley, New Jersey facility as of the Amendment Effective Date.

Daclizumab shall be deemed to be a Licensed Product, a humanized antibody now known by the generic name daclizumab, which binds to the interleukin-2 receptor (“IL-2R”). Daclizumab means any product that contains humanized anti-Tac (as defined under Field).

Licensed Product means any product, other than an Excluded Product, in the Field, including any Combination Product, the making, importation, use, offer for sale, or sale of which utilizes Licensee Know-How, Licensee Patents, or Joint Inventions or would, in the absence of this Second Amended and Restated Worldwide Agreement, infringe a Valid Claim of a Licensee Patent.

Combination Product means any product containing both an ingredient that causes it to be considered a Licensed Product and one or more other therapeutically active ingredients.

Other Licensed Products means all Licensed Products other than Daclizumab.

Licensor Patents means all patent applications owned or Controlled by Licensor alone or with a Third Party (“Sole Licensor Patents”) and all patent applications resulting from Joint Inventions (“Joint Licensee-Licensor Patents”) Covering Daclizumab, which are filed prior to or during the term of the 1989 Agreements, the 1999 Agreements or this Second Amended and Restated Worldwide Agreement in the United States 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 United States or foreign patent or inventor’s certificate covering products in the Field.

Licensor Patent Rights:
Patent No. 5,585,089, “Humanized Immunoglobulins,” issued December 17, 1996.
Patent No. 5,693,761, “Polynucleotides Encoding Improved Humanized Immunoglobulins,” issued December 2, 1997.
Patent No. 5,693,762, “Humanized Immunoglobulins,” issued December 2, 1997.
Patent No. 6,180,370 “Humanized Immunoglobulins and Method of Making the Same”, issued January 30, 2001.

Trademarks means the trademark “Zenapax®,” and all trademark registrations and applications therefor, and all goodwill associated therewith, and all other trademarks owned by Licensee (except for any Licensee housemarks or trade names) and used in connection with the sale or promotion of Nutley Dac in the Licensee Territory.

Licensor Know-How means, except as otherwise set forth, all inventions, discoveries, trade secrets, information, experience, data, formulas, procedures and results in the Field, and improvements thereon, including any information regarding the physical, chemical, biological, toxicological, pharmacological, clinical, and veterinary data, dosage regimens, control assays and specifications of Daclizumab.

Licensee Patents means both the Licensee Owned Patents and the Licensee Controlled Patents.

Licensee Owned Patents means all patent applications owned by Licensee or its Affiliates (“Sole Licensee Patents”) alone or with a Third Party, and all patent applications resulting from Joint Inventions (“Joint Licensee-Licensor Patents”) covering inventions in the Field that are filed prior to or during the term of this Second Amended and Restated Worldwide Agreement in the United States 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 United States or foreign patent or inventor’s certificate covering inventions in the Field. Licensee Owned Patents as of the Effective Date are, specifically, those listed.
Serial No. 60/416,302 – Use of IL-2 Receptor Antibodies

Joint Inventions means any inventions in the Field, whether patented or not, that are jointly made during the period beginning on January 31, 1989 and continuing until the end of the Commercialization Term by at least one (1) Licensor employee or person contractually required to assign or license patent rights covering such inventions to Licensor and at least one (1) Licensee-Nutley or Licensee employee or person contractually required to assign or license patent rights covering such inventions to Licensee-Nutley or Licensee.

Field of Use

Field means any humanized or chimeric antibody that binds to IL-2R, where “humanized” means a genetically engineered combination of a substantially human framework region and constant region, and complementarity determining regions from non-human antibodies, and where “chimeric” means a genetically engineered combination of human constant region and non-human variable region. “Antibodies in the Field” means humanized and chimeric antibodies that bind to IL-2R. It is believed that these Antibodies in the Field may be useful for therapeutic, diagnostic, imaging and similar purposes. It is understood that the Field includes, but is not limited to, that certain humanized murine monoclonal antibody prepared against the p55 component of IL-2R (“humanized anti-Tac”). Furthermore, the Field includes, but is not limited to, all improvements relating to humanized anti-Tac, including without limitation modifications in structure introduced by genetic engineering, or by chemical or enzymatic cleavage. Also included within the Field shall be alternate hosts for producing humanized anti-Tac, methods for purification, formulations incorporating humanized anti-Tac, and uses and methods of use for humanized anti-Tac in human medicine.

Daclizumab is a therapeutic humanized monoclonal antibody which was used for the treatment of adults with relapsing forms of multiple sclerosis.

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

The Parties will focus their initial efforts on the development of Licensed Products to treat psoriasis.   In addition, the Parties shall develop Licensed Products for Organ Transplant Indications.

Licensor grants a worldwide license under the Licensor Patents and Licensor Know-How in the Field to develop, make, have made, use, sell, offer for sale, have sold and import Licensed Products. Such license shall be co-exclusive with Licensor in the Co-Promotion Territory and exclusive even as to Licensor in the  Licensee Territory.

License Property

Licensed Product or Licensed Products means a formulation for use in the Field containing Anti-CD11a or any molecule derived from Anti-CD11a that is substituted as the subject of this collaboration.

Anti-CD11a means that certain monoclonal antibody, and other constructs with minor modifications thereto resulting from changes to the manufacturing process occurring after the transfer thereof from Licensor to Licensee which is now known as Efalizumab, and which recognizes the CD11a cell adhesion molecule on leucocytes, the full length sequences of the light and heavy chains.

Field of Use

The Field means the use of Licensed Product for the treatment or prevention of any human condition, disorder or disease.  The Parties will focus their initial efforts on the development of Licensed Products to treat psoriasis.

'Initial Indications' means the use of Licensed Product for the treatment of psoriasis and the Organ Transplant Indication. For purposes of this Agreement, psoriasis is a single indication regardless of whether the psoriasis is mild, moderate or severe. Separate Initial Indications will not result based on the severity of the psoriasis or organ transplant rejection, the onset period of organ transplant rejection, or the demographics of the patient class.

Psoriasis is a long-lasting autoimmune disease characterized by patches of abnormal skin.

Anti-CD11a is an investigational, recombinant, humanized monoclonal antibody designed to prevent the activation of T-cells and their migration to sites of inflammation. The first Phase III randomized trial will involve approximately 30 sites throughout the United States and Canada for patients with moderate-to-severe plaque psoriasis. A second Phase III study is planned to begin in the first quarter 2000.