Royalty Report: Drugs, Antibody, Cancer – Collection: 279976

License Grant

Licensor hereby grants to Licensee through the period and subject to the limitation on the number of Antigens, the right to receive for each Antigen designated by Licensee, a nonexclusive, worldwide license under the Licensor Licensed Patents to make, have made, use, import, offer to sell and sell Antibodies pursuant to a Licensor License Agreement. This right shall not extend to the Licensor Named Antigens.  The rights of Licensee under the Licensor License Agreements shall include the right to grant sublicenses for Antibodies in accordance with the terms of the applicable Licensor License Agreement.  Each license elected by Licensee hereunder shall be pursuant to a separate Licensor License Agreement and effective as of the date of execution by both parties.

License Property

Antigen means a target molecule, usually a protein, to which an Antibody specifically binds and includes all epitopes on that target molecule.

Antibody means any antibody directed against an Antigen and shall include, without limitation, monospecific and bispecific antibodies (but a separate license shall be required for the antigen involved for each arm of  a  bispecific antibody); less than full-length antibody forms such as Fv, Fab, and F(ab)2; single-chain antibodies; and antibody conjugates bound to a toxin, label or other moiety.  The term 'Antibody' shall include any and all such constructs directed against any particular Antigen.

Licensor Licensed Patents mean the following patents and patent applications known generally as the Cabilly patents and patent applications:

(a) U.S. Patent No. 4,816,567 and the claims relating to chimeric antibodies found in patents or patent applications arising from divisionals, continuations or continuations-in-part of any application from which U.S. Patent No. 4,816,567 claims priority or any substitute applications therefor, any patent issued with respect to any 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  as well as the foreign counterparts of the foregoing and any and all reissues, reexaminations or extensions of the foregoing (but in any event excluding U.S.S.N. 07/205,419 and foreign counterparts thereof) ('Chimera Patents') and (b)  any patent issuing based on U.S.S.N. 07/205,419 (a continuation of the application maturing into U.S. Patent No. 4,816,567) relating to the coexpression of immunoglobulin chains in recombinant host cells, as well as the divisionals, continuations or continuations-in-part of such U.S.S.N. 07/205,419.

4,816,567 – Recombinant immunoglobin preparations

Field of Use

This agreement pertains to the drug industry.

License Grant

Licensor hereby grants to Licensee (a) through the period and subject to the limitation on the number of Antigens provided, the right to receive for each Antigen designated by Licensee, a nonexclusive, worldwide (except as provided in this license under the Licensor Licensed Patents to make, have made, use, import, offer to sell and sell Antibodies pursuant to a Licensor License Agreement.  This right shall not extend to the Licensor Named Antigens.  The rights of Licensee under the Licensor License Agreements shall include the right to grant sublicenses for Antibodies in accordance with the terms of the applicable Licensor License Agreement.  Each license elected by Licensee hereunder shall be pursuant to a separate Licensor License Agreement and effective as of the date of execution by both parties.

License Property

Licensor Licensed Product means an Antibody with respect to which Licensor either has significant marketing rights or has done significant development (e.g., created, humanized or conducted preclinical or clinical development), the manufacture, import, use, sale or offer to sell of which would infringe, if not licensed under this Agreement, one or more claims of a Licensee Licensed Patent which have neither expired or have been disclaimed nor have been held invalid or unenforceable by a court or other body of competent jurisdiction from which no appeal has been or may be taken.

Antigen means a target molecule, usually a protein, to which an Antibody specifically binds and includes all epitopes on that target molecule.

Antibody means any antibody directed against an Antigen and shall include, without limitation, monospecific and bispecific antibodies (but a separate license shall be required for the antigen involved for each arm of  a bispecific antibody); less than full-length antibody forms such as Fv, Fab, and F(ab)2; single-chain antibodies; and antibody conjugates bound to a toxin, label or other moiety.  The term 'Antibody' shall include any and all such constructs directed against any particular Antigen.

Licensee Licensed Patents mean the following patents and patent applications known generally as the Cabilly patents and patent applications:
(a) U.S. Patent No. 4,816,567 and the claims relating to chimeric antibodies found in patents or patent applications arising from divisionals, continuations or continuations-in-part of any application from which U.S. Patent No. 4,816,567 claims priority or any substitute applications therefor, any patent issued with respect to any 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  as well as the foreign counterparts of the foregoing and any and all reissues, reexaminations or extensions of the foregoing (but in any event excluding U.S.S.N. 07/205,419 and foreign counterparts thereof) ('Chimera Patents') and (b)  any patent issuing based on U.S.S.N. 07/205,419 (a continuation of the application maturing into U.S. Patent No. 4,816,567) relating to the
coexpression of immunoglobulin chains in recombinant host cells, as well as the divisionals, continuations or continuations-in-part of such U.S.S.N. 07/205,419, the issued foreign counterparts of such U.S.S.N. 07/205,419 and
any and all reissues, reexaminations or extensions or patent term extension of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent ('Coexpression Patents').
4,816,567 – Recombinant immunoglobin preparations

Licensor Licensed Patents means the patents and patent applications identified and including any applications filed as of the Effective Date in the United States or any foreign jurisdiction.  Licensed Patents shall include U.S. or foreign patents or patent applications which claim priority to any application to which a listed U.S. patent also claims priority.  Licensor Licensed Patents shall also include any foreign equivalents, addition, continuation, continuation-in-part or division of such patents or patent applications or any substitute applications therefor, any patent issued with respect to any 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.  

5,693,089 – Method of collapsing an implantable appliance
5,693,761 – Polynucleotides encoding improved humanized immunoglobulins
5,693,762 – Humanized immunoglobulins

Field of Use

This agreement pertains to the drug industry.

License Grant

Licensor grants a worldwide, nonexclusive license under the Licensor Patents, including the right to grant sublicenses, to make, have made, import, use, market, promote, offer for sale and sell or otherwise dispose of Licensed Products.

License Property

The licensed patents are referred to as the Queen et al. Patents, and are related to humanized antibodies with respect to Licensee humanized antibody directed against the Antigen.

Antibody means any antibody directed against an Antigen, including without limitation, monospecific and bispecific antibodies, but a separate license shall be required for each Antigen targeted by a bispecific antibody; less than full-length antibody forms such as Fv, Fab, and F(ab’)2; single-chain antibodies; and antibody conjugates bound to a toxin, label or other moiety.

Antigen means the CD40 antigen designated by Licensee.

CD40 is an integral membrane protein found on the surface of B lymphocytes, dendritic cells, follicular dendritic cells, hematopoietic progenitor cells, epithelial cells, and carcinomas. It is a 45-50 kDa glycoprotein of 277 aa, which is a member of the tumor necrosis factor receptor superfamily.

Field of Use

Finished Products means any and all Licensed Products in a form for use by an end user and not intended for further chemical or genetic manipulation or transformation.

License Grant

Licensor hereby grants to Japanese Licensee, in the Field and within the Territory:
(a) a non-exclusive right and license, with the right to sublicense, under the Licensor Background Technology to make, have made, use, sell and import Program Antibodies;
(b) a non-exclusive right and license, with the right to sublicense, under any Patent Rights and Know-How Controlled by Licensor Covering any control antibodies provided by Licensor for the sole purpose of using such control antibodies to evaluate the Program Antibodies; and
(c) an exclusive right and license, with the right to sublicense, under any Program Patent Rights or other Patent Rights and Know-How Controlled by Licensor Covering each antibody-producing cell line created by Licensor that expresses a Program Antibody provided by Licensor, for the sole purpose of using such cell line to produce the applicable Program Antibody.

License Property

Licensor Background Technology means any and all Know-How and Patent Rights owned by Licensor as of the Effective Date or that come to be Controlled by Licensor during the Program Term (other than the Program Technology) and, in particular, any such Patent Rights and Know-How Covering any Collaboration Target, Program Antibody or Collaboration Product, that are necessary for (a) research related to Collaboration Target(s) or (b) Research and Development, Manufacture or commercialization of Program Antibody(ies) or Collaboration Product(s). For the avoidance of doubt, the Parties acknowledge that, to the extent any Licensor Background Technology is covered by a license or other agreement with a Third Party, such Licensor Background Technology shall, for all purposes of this Agreement, be subject to the limitations, restrictions and financial obligations established in such Third Party license or agreement, with Licensee being responsible for payment of the portion of the financial obligations related to this Agreement arising as a result of the Collaboration. Licensor Background Technology excludes the Human Engineeringâ„¢ Technology.

Antibody means any immunoglobulin molecule whether in monospecific or any other form and shall include, without limitation, immunoglobulin fragments, such as Fv, Fab, F(ab’) and single-chain antibodies.

Program Antibody means an Antibody Product that (a) is identified or discovered by Licensor in the course of the Collaboration, or (b) the Parties agree to acquire from a Third Party, and, in the case of clauses (a) and (b), selectively binds to and acts through a Collaboration Target; provided, however, that in no event shall an Antibody Product that is subject to one or more Pre-existing Obligations become a Program Antibody unless such designation is affirmatively agreed to by the Joint Steering Committee after disclosure of the nature of such Pre-existing Obligation(s) by the applicable Party, such agreement not to be unreasonably withheld or delayed.

Antibody Product means any composition of matter or article of manufacture consisting essentially of an Antibody (a) alone or (b) integrally associated with a composition of matter or article of manufacture (including without limitation conjugates bound to a toxin, label or other moiety) providing therapeutic, half-life, safety or other advantages to the Antibody.

Program Patent Rights means any Patent Rights Controlled by a Party or jointly by the Parties that Cover any Program Technology or Program Materials.

Patent Rights means all patents and patent applications existing as of the Effective Date and all patent applications thereafter filed and patents thereafter issued, including, without limitation, any continuations, continuations-in-part, divisionals, provisionals or any substitute applications, any patent issued with respect to any such patent applications, any reissue, reexamination, renewal or extension (including any supplemental protection certificate) of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent, and all foreign counterparts of any of the foregoing.

Field of Use

Field means any and all uses except, until the expiration or termination of the Chiron Exclusivity Period, the diagnosis, prevention, control or treatment of Cancer.

License Grant

Swiss Licensor shall grant Swiss Licensee a worldwide exclusive license, with the right to sublicense, under Licensor’s Intellectual Property Rights to develop, use, make, have made, export, commercialize, promote, offer for sale, sell and manufacture the Compound in a respective pharmaceutical product subject to the terms of the Commercialization Agreement.

Licensor hereby grants to Licensee the Maximally Available Target Exclusivity for each Licensor Target during the time required to complete the Discovery Project and until the expiration of the Commercialization Option Period.

License Property

Compound Patents shall have the meaning that Licensor shall be the owner of all patents and patent applications directed to compositions of matter related to any Compound identified by Licensor (the Compound Patents) and upon the execution of a Commercialization Agreement, Licensor shall assign to Licesee the Compound Patents; provided, however:
(i)  Licensee shall be the owner of all patents and patent applications directed to compositions of matter related to any IL-5R/CD3 bispecific antibody and Licensor hereby agrees to assign and hereby does assign all of its rights, title and interest in and to such patent or patent application, and, to the extent a third party that was requested by Licensor to perform any services or create any work and thereby became the owner of any rights specific to Licensee Targets, to secure access and use of such rights and then assign them to Licensee in accordance with this agreement; and (ii) any patent or patent application directed solely to any CD3 Antibody shall be owned by Licensor and Licensor shall grant Licensee a Co-exclusive license to such patent or patent application.

Compound shall mean an Antibody to a Licensee Target.

Target shall mean a secreted or at least partially extra-cellularly exposed protein against which Antibodies shall be discovered.

Antibody/ies shall mean antibody/ies or antibody derivative(s), which also includes antibody fragments and bispecific antibody formats.

Intellectual Property Rights means: (i) any and all European and/or foreign patent applications, letters patent, patents, or any division, continuation, continuation-in-part, reissue, or extension thereof, and any applications (including provisional applications) therefore; (ii) any and all trade secrets, know-how, and trade secret rights arising under the laws of Switzerland and/or laws of foreign countries; and (iii) all rights pursuant to (i) and (ii) hereinbefore as may hereafter come into existence, and all renewals and extensions thereof, regardless of whether such rights arise under the laws of Switzerland or any other state, country or jurisdiction.

Field of Use

This agreement pertains to the drug industry.

License Grant

The Master Agreement provides Licensee with the right to obtain a nonexclusive, worldwide, royalty-bearing license under the Licensed Patents under the terms and conditions of this Agreement.

Subject to the fulfillment by Licensee of all of the terms and conditions of this Agreement, Licensor hereby grants to Licensee and Licensee hereby accepts a nonexclusive license in the Territory under the Licensed Patents, including the right to grant sublicenses, to make, have made, import, use, offer to sell and sell Licensed Products in the Territory. Licensor shall be free at its discretion to enter into additional agreements with additional licensees at any time and on terms solely of its choosing.

License Property

5,693,089 – Method of collapsing an implantable appliance
5,693,761 – Polynucleotides encoding improved humanized immunoglobulins
5,693,762 – Humanized immunoglobulins

Licensed Patents means the patents and patent applications identified, and including any applications filed as of the Effective Date in the United States or any foreign jurisdiction. Licensor Licensed Patents shall include U.S. or foreign patents or patent applications which claim priority to any application to which a listed U.S. Patent also claims priority. Licensor Licensed Patents shall also include any foreign equivalents, addition, continuation, continuation-in-part or division of such patents or patent applications or any substitute applications therefor, any patent issued with respect to any 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.

Licensed Product(s) means an Antibody with respect to which Licensee has either significant marketing rights or has done significant development (e.g., created, humanized or conducted preclinical or clinical development), the manufacture, import, use, offer to sell or sale of which would infringe, if not licensed under this Agreement, a Valid Claim.

Antibody means any antibody directed against an Antigen and shall include, without limitation, monospecific and bispecific antibodies (but only with respect to the Antigen for a bispecific antibody); less than full-length antibody forms such as Fv, Fab, and F(ab’), single-chain antibodies and antibody conjugates bound to a toxin, label or other moiety, as well as any and all such constructs directed against the Antigen.

Antigen means the target molecule: IgE.

Field of Use

This agreement pertains to the drug industry.

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

Collaborator hereby grants to Licensee of Ireland an exclusive license (exclusive even as to Collaborator), with the right to sublicense, under the Collaborator Technology, to use, have used, Develop, have Developed, Manufacture, have Manufactured, Commercialize and have Commercialized Antibodies and Products in the Territory.

License Property

Product means any pharmaceutical product containing one or more Antibodies whose manufacture, use, sale, offer for sale or importation by Licensee in a given country in the Territory is covered by a Valid Claim under a Collaborator Patent Right or Sponsored Research Patent Right in such country.

Collaborator Patent Right means any Patent Right that (a) is Controlled by Collaborator or any of its Affiliates as of the Effective Date (including the Collaborator Patent Rights that comes into the Control of Collaborator or any of its Affiliates during the Term (other than through the grant of a license by Licensee) and (b) claims or discloses any (i) Antibody or Product (including the composition of matter thereof), (ii) method of making any Antibody or Product or materials used in any method of making any Antibody or Product, or (iii) methods of using any Antibody or Product.

Collaborator Technology means the Collaborator Patent Rights and Collaborator Know-How.

Patent Rights means any and all (a) issued patents, (b) pending patent applications, including all provisional applications, substitutions, continuations, continuations-in-part, divisions and renewals, and all patents granted thereon, (c) patents-of-addition, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including patent term adjustments, patent term extensions, supplementary protection certificates or the equivalent thereof, (d) inventor’s certificates, (e) other forms of government-issued rights substantially similar to any of the foregoing and (f) United States and foreign counterparts of any of the foregoing.

Field of Use

This agreement pertains to the drug industry.

License Grant

Licensor grants the Licensee of Bermuda a worldwide nonexclusive license under the Licensor Patent Rights, including the right to grant sublicenses, to make, have made, use and sell Licensed Products.

License Property

The patents are owned or controlled by Licensor related to humanized antibodies directed against the alpha subunit of the VLA-4 integrin.

The Licensed Products mean human therapeutic products of Licensee or Licensee’s sublicensees that include an Antibody developed by Licensee binding to the alpha subunit of the VLA-4 integrin whose development, manufacture, import, use or sale would, but for a license under this Agreement.

Antibody as used herein shall include, without limitation, monospecific and bispecific antibodies; less than full-length antibody forms such as Fv, Fab, and F(ab’)2; single-chain antibodies; and antibody conjugates bound to a toxin, label or other moiety.

Field of Use

The Licensee antibody directed against the alpha subunit of the VLA-4 integrin, currently designated as Antegrin® is for treatment of acute flares associated with multiple sclerosis.

License Grant

The Regents grants to the Licensee a license under its rights in and to Patent Rights to make, have made, use, Sell, offer for Sale and import Licensed Products and to practice Licensed Methods, in the United States and in other countries where The Regents may lawfully grant such licenses, only in the Field of Use.

The Regents grants to the Licensee a license under its rights in and to Property Rights to make, have made and use the Biological Materials to make, have made, use, Sell, offer for Sale and import Licensed Products, or to practice Licensed Methods, in the United States and in other countries where The Regents may lawfully grant such licenses, only in the Field of Use.

License Property

The Certain inventions are generally characterized as:
—  High Affinity Human Antibodies to Novel Tumor Antigens;
—  Bi-specific Single Chain Fv scFv Antibody Molecule; and,
—  Human Erb-B Antibodies.

Field of Use

The Field of Use means use as a therapeutic or diagnostic in humans. The Field of Use specifically excludes providing Licensed Services to third parties; the Sale, transfer, lease, exchange or other disposition or provision of Biological Materials, other than as incorporated in Licensed Products for Sale or as expressly permitted in this Agreement; the making, using or Selling of Biological Materials or Licensed Products for use in drug discovery or as a research reagent (other than for the development of Licensed Products);  the making, using or Selling of Non-Patent Products; and (v) all other uses and applications of Biological Material or Licensed Products, except as expressly permitted in this Agreement.

License Grant

On the Effective Date the Parties have terminated a certain Collaboration Agreement, and with this agreement, the Parties desire to reallocate the rights and responsibilities of the Parties with respect to further research and development of the GM-CSF Target.

Licensor grants to Licensee of Germany an exclusive, worldwide, license under the Licensor Licensed Technology to Exploit Licensed Products.

Licensor grants a worldwide, non-exclusive, perpetual, irrevocable and non-terminable license under the Collaboration Patents, as defined in the Collaboration Agreement, with the right to grant and authorize the grant of sublicenses, to Exploit Licensed Products.

License Property

BiTE Product means any composition or formulation consisting of or comprising a bi-specific Single Chain Antibody expressed as a single polypeptide chain, binding to T-cells.

GM-CSF Target means the whole or part of the human granulocyte macrophage-colony stimulating factor identified by the SWISS-PROT entry name CSF2 HUMAN and accession number P0414 l.

Single-Chain Antibodies
Antibodies are proteins produced by the body's immune system in response to the presence of antigens, such as bacteria, viruses or other disease causing agents. Antibodies of identical molecular structure that bind to a specific target are called monoclonal antibodies. Single-chain antibodies are genetically engineered antibodies that incorporate only the antigen binding domains of an antibody. Thus, SCAs have the binding specificity and affinity of monoclonal antibodies; however, in their native form they are only one-fifth to one-sixth the size of a monoclonal. The small size of SCAs typically gives them shorter half-lives than monoclonal antibodies, making them better suited for use in acute indications or in other indications where the large size of a monoclonal antibody would inhibit the compound from reaching the area of potential therapeutic activity. In addition, SCAs are a well-established discovery format-of-choice in generating antibodies from phage or yeast display libraries.

Field of Use

The field for Patent 5,223,409 is solely in the field of manufacture, use or sale of Single Chain Antibodies.

The field of use for this agreement otherwise is limited to not include the right to exploit the Products for Radioimmunoguided Surgery(TM), Reagents and kits in the research market for production and cloning of genes encoding Single Chain Antibodies and their fusions in a filamentous bacteriophage-derived vector system, and for expression and screening of Single Chain Antibodies fused with the minor coat protein or attachment or adsorption protein of filamentous bacteriophage, and, Single Chain Antibodies fused with, or for the assay or purification of, Tumor Necrosis l Factor alpha (TNF-a.) or Lymphotoxin.

Companies will collaboration to identify and develop antibody-based therapeutics for the treatment of inflammatory and autoimmune diseases.

License Grant

With this agreement, Licensee wishes Licensor to apply its technology and know-how to genetically engineer a Single-Chain Antibody.

The Licensor of Scotland agrees to grant the German Licensee under the patent rights a non-exclusive world-wide licence to the extent necessary to commercialise the Deimmunised antibody and/or the deliverables in the field.

Licensor grants for each specific Deimmunised antibody a non-exclusive licence under the patent rights to the extent necessary for worldwide commercialisation of the Deimmunised antibody derived from the specific Single-Chain Antibody sequence.

License Property

Licensor has certain proprietary technology, materials and know-how in genetic engineering of biological materials, including single-chain antibodies, relating to removal of potentially immunogenic sequences, from the variable regions of antibodies, or Delmmunisation to produce an antibody for therapeutic and/or in vivo diagnostic purposes.

Licensee is the owner of a cDNA which encodes a Single-Chain Antibody which binds to a specific antigen.

Licensor patent rights shall mean all patent applications and granted patents relevant to Deimmunization Technology.

Deimmunised antibody shall mean all genetically engineered variant(s) of the single-chain antibody  arising from the research.

Deimmunization technology shall mean the technical process applied by Licensor to generate Deimmunised antibody as outlined in the research program.

DeImmunisation increases the clinical potential of antibody and protein therapeutics by eliminating/reducing the T-cell response caused when the therapeutic molecule is recognised as foreign by the patient's immune system. The technology is based on ‘peptide threading' and works by identifying potential T-cell epitopes on the therapeutic antibody or protein. T-cell epitopes are sites on the therapeutic molecule which can bind to MHC class II, triggering a T-cell mediated immune response. Once this potentially immunogenic region of the antibody is identified, it is removed from the molecule by single amino acid substitutions, thus eliminating/reducing the therapeutic antibody or protein's immunogenicity and increasing its safety. This can be done without compromise to efficacy.

Field of Use

The field shall mean the field of human therapy and human in vivo and in vitro diagnostics limited to the Single-Chain Antibody.

License Grant

The English Licensor hereby grants to the English Licensee (i) a non-exclusive worldwide sublicense, with the right to grant further Sublicenses, under the Licensed Patent Rights to make, have made, use, import, offer for sale, and/or sell Licensed Products; and (ii) an exclusive worldwide license, with the right to grant Sublicenses, under the Licensor IP to make, have made, use, import, offer for sale, and/or sell Licensed Products.

License Property

US Patent #5,225,539 – Recombinant altered antibodies and methods of making altered antibodies

Licensed Product shall mean a product comprising a Humanized Antibody, the manufacture, use, offer for sale, sale, or importation of which by an unlicensed third party would infringe one or more Valid Claims of the Licensed Patent Rights, or which incorporates Licensor IP or Licensor Inventions.  The term “Licensed Product” does not include chimeric antibodies or murine antibodies.

Humanized Antibody shall mean an antibody that binds to Sphingosine-1-phosphate and is made by Licensor under this Agreement, the antibody comprising murine complementarity determining regions derived from Sphingomabâ„¢ together with human framework regions, and any modifications thereof.

Licensed Patent Rights shall mean the patents and patent applications licensed to Licensor and with respect to which Licensor has the right to authorize and grant sublicenses, as detailed in hereto, including any divisions, renewals, continuations, extensions, reexaminations, reissues, or continuations-in-part (to the extent that any such continuation-in-part claims subject matter as disclosed in the patents and applications listed thereof, as well as any patent that issues from any of the foregoing.

Licensor IP shall mean (i) any Licensor Invention and (ii) all patented and non-patented proprietary technology and information, in any form whatsoever, that is: (a) necessary or useful for making and using the Licensed Products, without regard to whether or not the technology or information is patentable; (b) owned, controlled, or developed by Licensor, as of the Effective Date or hereafter during the term of this Agreement; and (c) provided by Licensor to Licensee hereunder, including, but not limited to discoveries, formulae, materials, practices, methods, knowledge, know-how, processes, trade secrets, ideas, concepts, manufacturing, engineering, standard operating procedures, flow diagrams and charts, quality assurance, quality control data, technical data, manufacturing technology, research data and records, and all other confidential or proprietary technical and business information relating to the humanization of murine antibodies, generation of chimeric antibodies, or any gene expression vectors used in such methods and all improvements or modifications thereto.  For purposes of clarity, Licensor IP includes Licensor Inventions that satisfy (a), (b) and (c), above, while Licensor IP does not include Licensed Patent Rights as defined hereunder.

Licensor Invention shall mean any discovery or invention to the extent (i) made or conceived or reduced to practice by or on behalf of Licensor in the performance of the humanization of Licensees Sphingomabâ„¢ antibody under this Agreement, whether or not patentable, and (ii) covering only generally applicable methods or techniques for humanizing antibody proteins or for constructing a vector or reagent used to humanize or express an antibody.

Field of Use

Licensee’s lead product candidate, Sphingomab™, is a monoclonal antibody (mAb) against sphingosine-1-phosphate (S1P), an innovative and validated cancer target.

Sphingomabâ„¢ is the original mouse version of this monoclonal antibody.

License Grant

Both parties enter into a joint cooperation.  Licensor grants to Swiss Licensee during the Agreement Period a world-wide license under its Know-How and Patent Rights, with the right to grant sublicenses, to make, have made, use and sell the Product(s) for use in the Field.   Said license shall be exclusive in the Exclusive Territories and shall be co-exclusive with Licensor in the Semi-exclusive Territories.  Licensee grants to Licensor during the Agreement Period a license under its Know-How and Patent Rights, to make, have made, use and sell the Product(s) for use in the Field.  Said license shall be limited to the Semi-exclusive Territories and shall be co-exclusive with Licensee in said Territories.

License Property

Product(s) shall mean the monoclonal antibodies owned or controlled by Licensor and Licensee for use in the Field, as described in the U.S. patent application(s) of Licensor and the U.K. patent application of Licensee, and fragments, toxin conjugates, antibody toxin chimeric constructs, humanized or reshaped antibodies derived from such monoclonal antibodies including such forms as are ready to be administered in humans.

Patent Rights shall mean any patent application or patent(s) owned or controlled by Licensor or Licensee whose claims cover the manufacture, use, or sale of the Product(s), as well as any additional patents hereafter issuing from additional patent applications relating to the Product(s), including, but not limited to, a method of use of the Product(s), and any substitutions, continuations, continuations-in-part, divisions, reissues, re-examinations, renewals, or extensions of the terms thereof.

Field of Use

Field shall mean anti-IgE antibody-based treatments in humans for IgE-mediated reactions, which most likely will include, but not be limited to, asthma and other diseases commonly termed allergies. The anti-IP: treatment is based on mechanisms that are specifically directed towards reducing or eliminating circulating lgE and lgE producing B cells within the immune system. The scope of the Field and definition of Product(s) are not intended to include other areas of allergy research (including approaches such as peptides, or factors, including IL-4 and CD23) or development of antiidiotypic antibodies, which may be useful in modulating lgE production in humans.

The Parties are jointly developing an anti-IgE antibody product to treat allergies and allergic asthma.

License Grant

The Licensor of England grants to Licensee of Germany a nonexclusive, worldwide license under the Licensor Licensed Patents and the Licensor Background Know-How to Exploit Licensed Products in the Field.

License Property

Licensor is a UK-based biotechnology company using its proprietary technologies and capabilities in human monoclonal antibodies for drug discovery and drug development.

Licensed Product means any product, substance or formulation arising from the Target Program, and the Development, manufacture, importation, use or sale of which would but for the provisions of this Agreement infringe one or more Valid Claims under the Licensor Licensed Patents, or which utilizes the Licensor Background Know-How.

The know-how includes Training Manual Antibody Phage Display 2002, and, mammalian expression IgG vectors.

Field of Use

The Field means the prognosis, diagnosis, prophylaxis or treatment of human diseases or conditions by modulation of the Target. Target means the whole or part and natural variants of the granulocyte-macrophage colony stimulating factor (GM-CSF) identified by the SWISS-PROT entry name CSF2_HUMAN and accession number P04141 with the amino acid sequence which is specifically recognized by an Antibody binding to the foregoing.

Licensee obtains the right within the framework of their collaboration to use Licensor’s intellectual property in phage display to create and commercialise novel antibody products against a defined number of targets.

License Grant

Pursuant to the master agreement, each Antigen will have its unique patent agreement.  Licensor grants to Licensee with respect to four (4) Antigens), the rights upon written notice to receive licenses under the Patent Rights for up to four (4) Antigens designated by Licensee.

Each license shall be a nonexclusive, worldwide license under the Licensors Patent Rights to make, have made, use, import, market, promote, offer for sale and sell or otherwise dispose of Antibodies pursuant to a Licensors License Agreements. The rights of Licensee shall include the right to grant sublicenses for Antibodies in accordance with the terms of the applicable License Agreement.

License Property

The licensed patents are for Humanized Immunoglobulins and Polynucleotides Encoding.

The Antigens are target molecules to which an Antibody specifically binds and includes all epitopes on that target molecule.

The licensed product means an Antibody with respect to which Licensee has either significant marketing rights or has done significant development, including without limitation created, humanized or conducted preclinical or clinical development, the manufacture, import, use, offer to sell or sale of which would infringe, if not licensed under this Agreement, also known as a Valid Claim.

Field of Use

Licensee identifies and develops therapeutic monoclonal antibodies to address significant unmet medical needs in the areas of immunology, infectious diseases and cancer.  Monoclonal antibodies are genetically engineered antibodies that target a specific foreign substance, or antigen.

License Grant

Licensor grants the Japanese Licensee an exclusive non-transferable license and/or right, without the right to grant sublicenses, to use Licensor delivered pursuant to Licensee to identify, isolate, modify and develop Discovery Products; and a non-exclusive, non-transferable license and/or right, without the right to grant sublicenses.

License Property

Licensor is engaged in the research and development of product candidates, including without limitation vaccine, Antibodies and blood plasma products, for use in treating and/or preventing human diseases.

The Licensed Product means an Antibody or Antibody Product that is either a Discovery Product or a TAE-Only Product.

Antibody shall mean any molecule, including full immunoglobulin molecules (e.g., IgG, IgM, IgE, IgA and IgD molecules) and ScFv, Fv and Fab molecules, that has an amino acid sequence by virtue of which it specifically interacts with an antigen, immunogen or hapten or which elicits an immune response and wherein that amino acid sequence consists essentially of a functionally operating region of an antibody variable region, including any naturally occurring or recombinant form of such a molecule.

Antibody Product means any composition of matter or article of manufacture consisting essentially of an Antibody alone or integrally associated with a composition of matter or article of manufacture (including without limitation conjugates bound to a toxin, label or other moiety) providing therapeutic, half-life, safety or other advantages to the Antibody.

Field of Use

The Field means the discovery, research, development, manufacture and/or commercialization of Licensed Products for the treatment, palliation or prevention of any disease or condition in humans.

License Grant

Licensor shall grant to Irish Licensee and any Licensee Development Partner of whom Licensee provides written notice to Licensor an exclusive, worldwide, royalty-bearing license and right under the Licensor Patent Rights and/or any other patents, patent applications or intellectual property owned or licensed by Licensor (with the right to license or sublicense), which claim or cover a given Licensee Development Product or its manufacture or use to make, have made, use, sell, offer to sell, import, export, develop, commercialize and manufacture such Licensee Development Product. During the pendency of each Licensee Project and for a period of eighteen months (18) thereafter, Licensor covenants that it will not conduct any activities on its own behalf or on behalf of a Third Party which relates to or encompasses the Licensee Target that is the subject of such Licensee Project.

License Property

Antibody Evolution means the alteration of the nucleic acids encoding an Immunoglobulin by saturation mutagenesis as described in the Licensor Patent Rights, by means other than Antibody Phage Display.

Licensor Patent Rights means the inventions patentable under applicable patent law that are claimed in the patent applications and patents listed (a) hereto and all divisions, continuations, continuations-in-part, applications claiming priority thereto, and substitutions thereof; all foreign patent applications corresponding to the preceding applications; all U.S. and foreign patents issuing on any of the preceding applications, including extensions, reissues and re-examinations; and any patents or patent applications, whether now existing or obtained in the future, owned or controlled by Licensor containing a claim that is dominating over the foregoing patent rights (i.e., is necessarily infringed by the practicing of a claim in one of the foregoing applications); and any patents or patent applications covered by any Licensor Third Party Licenses, a list of which is set forth.
6,171,820 – Saturation mutagenesis in directed evolution
6,479,258 – Non-stochastic generation of genetic vaccines

Licensor Evolution Technologies means the inventions patentable under applicable patent law that are claimed in the Licensor Patent Rights which both (a) are owned or controlled by Licensor and (b) either (i) comprise evolution of a gene and/or gene pathway by changing more than 50% of the codons and/or amino acids of such gene and/or genepathway to more than 50% of every other possible codon and/or amino acid or such gene and/or gene pathway, or (ii) comprise evolution of a gene and/or gene pathway by creating and screening a non-stochastically produced library of molecules by combining tragments of a plurality of genes chosen by design to reassemble compleete genes and/or gene pathways according to the patentable methods embodied by inventions described in the Licensor Patent Rights.

Licensed Immunoglobulin means (a) with respect to the licenses and rights granted, any Immunoglobulin discovered, isolated or characterized by Licensor through the use of Antibody Evolution, and (b) with respect to the licenses granted, Licensed Immunoglobulin includes any Immunoglobulin discovered using Antibody Evaluation but outside the Manufacturing Field, and for purposes of this agreement hereof, Licensed Immunoglobulin includes any Immunoglobulin within the Manufacturing Field.

Licensed Immunoglobulin Information means any data, know-how or other information relating, concerning or pertaining to a Licensed Immunoglobulin, including without limitation data, know-how or other information characterizing or constituting such Licensed Immunoglobulins polynucleotide or amino acid sequence, purported function or utility, antigen binding affinity, or physical or biochemical property.

Immunoglobulin means any molecule, including without limitation, full immunoglobulin molecules (e.g., IgG, IgM, IgE, IgA and IgD molecules) and ScFv, Fv and Fab molecules, that has an amino acid sequence by virtue of which it specifically interacts with an antigen and wherein that amino acid sequence consists essentially of a functionally operating region of an antibody variable region including without limitation any naturally occurring or recombinant form of such a molecule.

Licensee Patent Rights means the inventions patentable under applicable patent law that are claimed in the patent applications and patents listed hereto and all divisions, continuations, continuations-in-part, applications claiming priority thereto, and substitutions thereof; all foreign patent applications corresponding to the preceding applications; all U.S. and foreign patents issuing on any of the preceding applications, including extensions, reissues and re-examinations; and any patents or patent applications, whether now existing or obtained in the future, owned or controlled by Licensee containing a claim that is dominating over the foregoing patent rights (i.e., is necessarily infringed by the practicing of a claim in one of the foregoing applications).
5,595,898 – Modular assembly of antibody genes, antibodies prepared thereby and use
6,204,023 – Modular assembly of antibody genes, antibodies prepared thereby and use

Licensee Technology Platform means all know-how, trade secrets, inventions, data, processes, procedures, devices, methods, formulas, media and all cell lines, reagents, protocols and other information, whether or not patentable, that either (a) constitute or relate to any biological target, antigen, receptor, cell, expression vector, disease, condition, nucleic acid, protein (including, without limitation, an Immunoglobulin) or protein-conjugate which is the subject of or arises out of any Licensee Project or (b) relate to the discovery, optimization, expression or manufacture of Immunoglobulins, in each case which are owned by or licensed to Licensee as of the Effective Date and are disclosed to Licensor or used by Licensor or Licensee in connection with a Licensee Project. For the avoidance of doubt, the term 'Licensee Platform Technology' shall include any prokaryotic expression technology and methods and/or antibody phage display technology and methods.

Licensor Collaborator means any person or entity on whose behalf Licensor engages in Antibody Evolution and/or a person or entity who is the intended recipient of Licensed Immunoglobulins or Licensed Immunoglobulin Information transferred from Licensor.

Licensee Development Product means any composition of matter or article of manufacture consisting essentially of an Immunoglobulin or protein discovered or optimized by Licensor for Licensee pursuant to a Licensor Action Plan and where such Immunoglobulin or protein was discovered or optimized using techniques, methods or materials covered by one or more Valid Claims of any patent or patent application controlled by Licensor, including the Licensor Patent Rights.

Field of Use

The collaborative agreement is to develop optimized therapeutic antibodies.

Licensor Field means (a) Research and Development and (b) the diagnosis, treatment, prevention or prophylaxis of any human or animal condition or disease. The Licensor Field shall not include any Non-Approved Uses.

Manufacturing Field means the production in prokaryotes of an Immunoglobulin for the treatment, diagnosis or prophylaxis of a human or animal disease or condition in quantities which exceed Research Quantities, and shall include commercial, industrial or clinical scale production.

License Grant

Licensor hereby grants to Licensee a right and license or, in the case of Patents licensed to Licensor under the Licensor In-Licenses, a sublicense, under the Licensed Technology, to make, have made, use, offer to sell, sell and have sold Products except as set forth in this agreement in the relevant Field, and in the Territory.

License Property

Table 1 BR96sFv-PE40 Program

The following patents and patent applications, together with the know-how related thereto, constitute the BR96 sFV-PE40 Program:

Patent
  
Description
License Type

Number
Number

57,444
5,491,088
  
Murine monoclonal antibody BR96, chimeric BR96 and antigen binding fragments of BR96.
Exclusive

459,354

  
Recombinant BR96 molecules having the antigen binding region of murine BR96.
Exclusive

Table 2 BR96/Drug Conjugate Program

Application
Patent
  
Description
License Type

Number
Number

353,729
5,122,368
  
Linker chemistry having an acylhydrazone linkage through C13 keto group of anthracycline to nonimmunoglobulin ligand. Linker arm also includes thioether or disulfide bond.
Partially-Exclusive for Linkers

96,628

  
Acylhydrazone linkage through C13 keto group of anthracycline to immunoglobulin. Linker arm also includes thioether or disulfide bond.
Partially-Exclusive for Linkers

824,951
5,622,929
  
Anthrecycline ligand conjugates where linkage is an acylhydrazone through C13 keto position of anthracycline. Linker also contains succinimido moiety. Chemistry is used to make first generation chiBR96-Dox.
Partially-Exclusive for Linkers

08/468,162
5,606,017
  
Anthracycline intermediate having acylhydrazone linkage through C13 keto position of anthracycline and a Michael Addition Receptor. Intermediate in conjugation used to make first generation chiBR96-Dox.
Partially-Exclusive for Linkers

08/469,840

  
Process for conjugation using intermediate above with reduced immunoglobulin to increase total drug to antibody yield. Process is used to make first generation chiBR96-Dox.
Partially-Exclusive for Linkers

62,366

  
Enzyme cleavable peptide linker for making cytotoxic drug ligand conjugates. Linkers are used to make second generation BR96-Dox.
Partially-Exclusive for Linkers

57,444
5,491,088
  
Murine monoclonal antibody BR96, chimeric BR96 and antigen binding fragments of BR96.
Exclusive

77,253

  
Immunoconjugates of murine monoclonal antibody BR96, chimeric BR96 and other recombinant antigen binding fragments. Includes single chain and bispecific recombinant constructs.
Exclusive

333,840

  
Methods of treating human carcinoma by administering murine BR96, chimeric BR96 or any recombinant antigen binding construct either by itself or conjugates with various agents. Also includes diagnostic kits.
Exclusive

459,354

  
Recombinant BR96 molecules having the antigen binding region of murine BR96.
Exclusive

08/285,936

  
Mutants of BR96 which have increased binding affinity/avidity to antigen.
Exclusive

08/487,860

  
Mutants of BR96 which have increased binding affinity/avidity to antigen.
Exclusive

60/030/367

  
Branched peptide linker for linking thiol group on targeting ligand to two or more drug moieties.
Partially-Exclusive for Linkers

5,204,244
  
Production of chimeric antibodies by homologous recombination.
Non-Exclusive

5,202,238
  
Production of chimeric antibodies by homologous recombination.
Non-Exclusive

5,482,856
  
Production of chimeric antibodies by homologous recombination.
Non-Exclusive

Table 3 G28-5 SfV/Immunotixin Program

The patents and patent applications (the “Washington Patents”), together with the know-how related thereto, sublicensed under the Washington Agreement constitute the G28-5 sFv/Immunotoxin Program. [Exclusive]

Table 4 BD1 Program

The following patents and patent applications, together with the know-how related thereto, constitute the BD1 Program:

Application
Patent
Description
License Type

Number
Number

08/245,754
5,541,110
Isolated oligonucleotide sequence encoding Bryodin 1, recombinant vectors and plasmids, and transfected host cells.
Exclusive

08/597,731

Methods for the recombinant production of Bryodin 1 and Bryodin 1-ligand fusion proteins.
Exclusive

08/324,301
5,597,569
Ribosome-inactivating protein Bryodin 2 in an isolated form, linked to a ligand as a conjugate or a fusion protein, pharmaceutical compositions, nucleotide sequence, transfected host cells and recombinant production.
Exclusive

Table 5 ADEPT Program

The following patents and patent applications, together with the know-how related thereto, constitute the ADEPT Program:

Application

Number
Patent
Description
License Type

(filed 5/7/96)
Number

Recombinant L49sFv-¨ lactamase fusion proteins which recognize p97 melanoma antigen and activate-cephalosporin derivatized prodrug molecules.
Exclusive

211,301
4,975,278
Methods for delivering cytotoxic agents to tumor cells by administering an effective amount of at least one antibody-enzyme conjugate, wherein the antibody is specific for a tumor associated antigen and the enzyme converts at least one weakly cytotoxic prodrug to its corresponding cytotoxic parental form; and the administration of an effective amount of the prodrug.
Non-Exclusive

Table 6 Residual Program

The following patents and patent applications, together with the know-how related thereto, constitute the Residual Program

Application
Patent
Description
License Type

Number
Number

684,759
4,935,495
Monoclonal antibodies, Fab, F(ab1)2 or Fv fragments thereof which compete for binding with L6 to its antigen.
Partially-Exclusive for Cancer

776,321
4,906,562
Methods for detecting malignancy using L6 or other monoclonal antibodies or fragments thereof which compete with L6 for binding to its antigen.
Exclusive

523,309
5,091,177
Method for reducing population of tumor cells using L6 or monoclonal antibodies which compete for binding with L6 to its antigen.
Exclusive

443,696
5,242,824
Monoclonal antibody BR64 and antigen binding fragments thereof.
Exclusive

08/726,528

Monoclonal antibodies and recombinant antigen binding molecules which recognize the G733-1 but not G733-2 antigen. Specifically BR110.
Partially-Exclusive for Cancer

527,227
5,165,922
Method of treating breast carcinoma in an unresponsive patient by first administering monoclonal antibody L6 followed by administration of a chemotherapeutic agent.
Exclusive

5,663,158
Method for treating vascular leak syndrome.
Non-Exclusive

The Residual Program also includes antibodies L6, L49, BR64, BR110, OV578.1 and OV569.1 [Exclusive]

Field of Use

Field shall be the treatment and diagnosis of cancer in humans.

The Field with respect to Licensed Technology for which Licensee is granted a right and license that is partially exclusive shall be:

(i) if this Agreement indicates that such license is partially exclusive for linkers, all monoclonal antibody targeting applications; or (ii) if the agreement indicates that such license is partially exclusive for cancer, the treatment and diagnosis of cancer in humans. The Field with respect to Licensed Technology for which Licensee is granted a right and license that is non-exclusive shall be the treatment and diagnosis of cancer in humans. Notwithstanding the foregoing, the Field with respect to the G28-5 Licensed Technology shall be for the use of the antibody G28-5 fused with a toxin for the treatment of cancer in humans.

License Grant

Licensor grants to Licensee a nonexclusive license under Licensed Patents during the Term to research, develop, make and have made, use, sell, offer for sale, export and import Licensed Product in the Territory in the Field of Use.

License Property

“Licensed Patents” shall mean (i) U.S. Patent No. 6,331,415.

Licensor owns and controls certain patent rights relating to methods and compositions in the field of antibodies.

Licensed Patent is for Methods of producing immunoglobulins, vectors and transformed host cells for use therein.

Licensed Product shall mean any antibody that binds specifically to CD40, the making or having made, using, selling, offering for sale or importing of which, but for the license granted under this Agreement, would infringe a Valid Claim of a patent included in Licensed Patents.

CD40 is an integral membrane protein found on the surface of B lymphocytes, dendritic cells, follicular dendritic cells, hematopoietic progenitor cells, epithelial cells, and carcinomas. It is a 45-50 kDa glycoprotein of 277 aa, which is a member of the tumor necrosis factor receptor superfamily.

Field of Use

The Field of Use shall mean any human use.  Licensee is developing, and intends to commercialize, antibody products that bind to the CD40 antigen.