Royalty Report: Drugs, Antibody, Proteins – Collection: 294274

License Grant

The parties collaborated to develop a long-acting Factor VII compound and amended the Original Agreement to incorporate all of the Amendments into one document.

Licensor hereby grants, and agrees to grant, to Swiss Licensee an exclusive (even as to Licensor), royalty-bearing license under the Licensor Intellectual Property in the Field of Use during the Term, (i) to conduct research, sample, develop (including clinical development), manufacture, make, use, market, promote, sell, offer for sale, have sold, distribute, import and export New Products in the Territory, and (ii) to use the Reagents in the Territory solely for the purpose of making New Products. Such license does not permit Licensee (x) to practice or use the Licensor Intellectual Property outside the Field of Use or (y) to sublicense any of its rights without the prior written approval of Licensor.

Licensor hereby grants, and agrees to grant, to Licensee a worldwide, exclusive (even as to Licensor), perpetual, irrevocable, and royalty-bearing (subject only to the payment of royalties in accordance with this agreement) license, with the right to sublicense, to any Carved Factor VII Claims that do not constitute Licensee Improvements for any and all purposes. In addition to the foregoing, Licensor hereby grants, and agrees to grant, to Licensee a worldwide, exclusive (even as to Licensor), perpetual, irrevocable, and royalty-free license, with the right to sublicense, to any Carved Factor VII Claims that constitute Licensee Improvements for any and all purposes.

License Property

New Product shall mean the following: (a) any of the Licensee Materials modified using either (i) the Licensor Technology, (ii) any Licensor Improvements, or (iii) any combination of all or some of (i) and (ii) above, and (b) any Licensee Materials covered by any Carved Factor VII Claims (except to the extent such claims constitute Licensee Improvements) .

Potential Carved Factor VII Claims shall mean any composition-of-matter claims and any method of treatment claims that are supported by Patent Rights Controlled by Licensor that (i) do or could explicitly and solely recite and claim Licensee Materials, or (ii) any Licensee Improvements made or reduced to practice by Licensor.

Licensor Technology means the Licensor Patents and any Know-How Controlled by Licensor relating to methods and processes for the glycosylation design and remodeling of proteins, peptides and antibodies, including, without limitation, its GlycoAdvance®, GlycoPEGylation™ and GlycoConjugation™ technologies, and other carbohydrate dynthesis processes, and all Know-How resulting from work conducted by Licensor during the Term.

Licensor Patents means (a) all Patent Rights relating to methods and processes for glycosylation design and remodeling of proteins, peptides and antibodies that are Controlled by Licensor, including, but not limited to: (i) the Patent Rights listed, (ii) the Patent Rights developed by Licensor in the conduct of the Work Plan during the Term of this Agreement, and (iii) any later acquired Patent Rights Controlled by Licensor and used to develop any New Product, and (b) all Patent Rights Controlled by Licensor that would be infringed by the research, development (including clinical development), manufacture, making, use, marketing, promotion, sale, offer for sale, distribution, import and export of New Products in the Territory.
US Patent #6,800,468 – UDP-galactose: .beta.-N-acetyl-glucosamine .beta.1,3galactosyltransferases, .beta.3Gal-T5
US Patent #6,995,004 – UDP-N-ACETYLGLUCOSAMINE: GALACTOSE-.beta. 1,3-N-ACETYLGALACTOSAMINE-.alpha.-R / N-ACETYLGLUCOSAMINE-.beta. 1,3,-N-ACETYLGALACTOSAMINE-.alpha.-R (GLCNAC TO GALNAC) .beta.1,6-N-ACETYLGLUCOSAMINYLTRANSFERASE, C2/4GNT
US Patent #6,635,461 – UDP-N-acetylglucosamine: galactose-.beta.1, 3-N-acetylgalactosamine-.alpha.-R/(GlcNAc to GalNAc) .beta.1,6-N-acetylglucosaminyltransferase, C2GnT3

Licensor Improvements means any and all Improvements relating to the Licensor Technology made, conceived, or reduced to practice by (i) either Licensor or Licensee or both in the conduct of the Work Plan under this Agreement, (ii) either Licensor or Licensee or both under this Agreement, (iii) Licensee in the practice of any Licensor Technology under the licenses granted to Licensee in this agreement, or (iv) Licensee in the conduct of any activity using any Ownership Rights assigned to Licensee pursuant to this Agreement, in each case of (i), (ii), (iii) or (iv), other than the Licensee Materials, the Licensee Materials modified using the Licensor Technology and New Product. Specifically excluded from Licensor Improvements are (1) formulations, combinations and methods of treatment to the extent relating to Licensee Materials, the Licensee Materials modified using the Licensor Technology and New Products and (2) analytical techniques and purification methods invented, developed or reduced to practice solely by Licensee that did not originate from or are not derived from Licensor (collectively, the Techniques).

Licensor Intellectual Property means Licensor Technology and the Licensor Improvements.

Patent Rights shall mean individually and collectively any and all patents and/or patent applications and provisional applications, all inventions disclosed therein, and any and all continuations, continuations-in-part, continued prosecution applications, divisions, renewals, patents of addition, reissues, confirmations, registrations, revalidations, revisions and re-examinations thereof, utility models, petty patents, design registrations and any and all patents issuing therefrom and any and all foreign counterparts thereof and extensions of any of the foregoing including without limitation extensions under the U.S. Patent Term Restoration Act, extensions under the Japanese Patent Law, and Supplementary Protection Certificates (SPCs) according to Counsel Regulation (EEC) No. 1768/92 and similar extensions for other patents under any applicable law in any country of the world. Licensee hereby grants to Licensor, for the term of the Work Plan, a non-exclusive, royalty free, license under the Licensee Technology to use such Licensee Technology for the sole purpose of carrying out its obligations under the Work Plan. Licensee shall retain at all times all of its rights, title and interest to the Licensee Technology.

Licensor Exclusive Compounds shall mean any and all forms of erythropoietin and granulocyte colony stimulating factor including, but not limited to, with respect to either of the foregoing: full length proteins, truncated proteins, fusion proteins, analogs, mutants, splice variants, and conjugates with other molecular entities such as proteins, peptides, organic or inorganic substances.

Field of Use

Licensor's technology is to develop and commercialize next-generation versions of Factors VIIa, VIII and IX.

Factor VIIa is used in the treatment of bleeding episodes and for the prevention of bleeding during surgery or invasive procedures in patients with congenital hemophilia with inhibitors to coagulation factors VIII or IX.

License Grant

The parties amend and replace the Original Agreement to separate the next generation recombinant coagulation Factor IX into its own Agreement.  Licensor hereby grants, and agrees to grant, to Danish Licensee, as of the Original Date , the following rights and licenses:
Exclusive License.  As of the Original Date, Licensor hereby grants, and agrees to grant, to Licensee an exclusive (even as to Licensor), royalty-bearing license in the Field of Use under the Licensor Intellectual Property used or required to be used in the Field of Use during the Term, (i) to conduct research, sample, develop (including clinical development), manufacture, make, use, market, promote, sell, offer for sale, have sold, distribute, import and export New Products in the Territory, and (ii) to use the Reagents in the Territory solely for the purpose of making New Products.  
Limited Sublicense Rights.  Licensee shall be entitled to grant full sublicenses to its Affiliates and limited sublicenses to its distribution, marketing and/or sales partners.

License Property

Licensor Patents means (a) all Patent Rights relating to methods and processes for glycosylation design and remodeling of proteins, peptides and antibodies that are   Controlled by Licensor, including, but not limited to, (i) the Patent Rights listed.

6,800,468 – UDP-galactose: .beta.-N-acetyl-glucosamine .beta.1,3galactosyltransferases, .beta.3Gal-T5
6,995,004 – UDP-N-ACETYLGLUCOSAMINE: GALACTOSE-.beta. 1,3-N-ACETYLGALACTOSAMINE-.alpha.-R / N-ACETYLGLUCOSAMINE-.beta. 1,3,-N-ACETYLGALACTOSAMINE-.alpha.-R (GLCNAC TO GALNAC) .beta.1,6-N-ACETYLGLUCOSAMINYLTRANSFERASE, C2/4GNT
6,635,461 – UDP-N-acetylglucosamine: galactose-.beta.1, 3-N-acetylgalactosamine-.alpha.-R/(GlcNAc to GalNAc) .beta.1,6-N-acetylglucosaminyltransferase, C2GnT3

Carved Factor IX Claims shall mean any Potential Carved Factor IX Claim with respect to which the parties have filed a separate patent application.

Potential Carved Factor IX Claims shall mean any composition-of-matter claims and any method of treatment claims that are supported by Patent Rights Controlled by Licensor that (i) do or could explicitly and solely recite and claim Licensee Materials, or (ii any Licensee Improvements made or reduced to practice by Licensor.

Reagents means the enzymes and sugar nucleotides required to use the Licensor Technology in the manufacture of New Products.

New Product shall mean the following: (a) any of the Licensee Materials modified using either (i) the Licensor Technology, (ii) any Licensor Improvements, or (iii) any combination of all or some of (i) and (ii) above, and (b) any Licensee Materials covered by any Carved Factor IX Claims (except to the extent such claims constitute Licensee Improvements).

Licensor Exclusive Compounds shall mean any and all forms of erythropoietin and granulocyte colony stimulating factor including, but not limited to, with respect to either of the foregoing: full length proteins, truncated proteins, fusion proteins, analogs, mutants, splice variants, and conjugates with other molecular entities such as proteins, peptides, organic or inorganic substances.

M1 Profile for the New Factor IX Product means the parameters for candidate selection required for PEG-F9, as amended from time to time.

Licensor Intellectual Property means Licensor Technology and the Licensor Improvements.

Licensor Technology means the Licensor Patents and any Know-How Controlled by Licensor relating to methods and processes for the  glycosylation design and remodeling of proteins, peptides and antibodies, including, without limitation, its GlycoAdvance®, GlycoPEGylationâ„¢ and GlycoConjugationâ„¢ technologies, and other carbohydrate synthesis processes, and all Know-How resulting from work conducted by Licensor during the Term.

Licensor Improvements means any and all Improvements relating to the Licensor Technology made, conceived, or reduced to practice by (i) either Licensor or Licensee or both in the conduct of the Original Work Plan under the Original Agreement or the Work Plan under this Agreement, (ii) either Licensor or Licensee or both under this Agreement.

Patent Rights shall mean individually and collectively any and all patents and/or patent applications and provisional applications, all inventions disclosed therein, and any and all continuations, continuations-in-part, continued prosecution applications, divisions, renewals, patents of addition, reissues, confirmations, registrations, revalidations, revisions and re-examinations thereof, utility models, petty patents, design registrations and any and all patents issuing therefrom and any and all foreign counterparts thereof and extensions of any of the foregoing including without limitation extensions under the U.S. Patent Term Restoration Act, extensions under the Japanese Patent Law, and Supplementary Protection Certificates (SPCs) according to Counsel Regulation (EEC) No. 1768/92 and similar extensions for other patents under any applicable law in any country of the world.

Field of Use

Factor VIIa is used in the treatment of bleeding episodes and for the prevention of bleeding during surgery or invasive procedures in patients with congenital hemophilia with inhibitors to coagulation Factors VIII or IX.

License Grant

The parties amend and replace the Original Agreement to separate the next generation recombinant coagulation Factor VIII into its own Agreement.  Licensor hereby grants, and agrees to grant, to Danish Licensee, as of the Original Date , the following rights and licenses:

Exclusive License.  As of the Original Date, Licensor hereby grants, and agrees to grant, to Licensee an exclusive (even as to Licensor), royalty-bearing license in the Field of Use under the Licensor Intellectual Property used or required to be used in the Field of Use during the Term, (i) to conduct research, sample, develop (including clinical development), manufacture, make, use, market, promote, sell, offer for sale, have sold, distribute, import and export New Products in the Territory, and (ii) to use the Reagents in the Territory solely for the purpose of making New Products.

Limited Sublicense Rights: Licensee shall be entitled to grant full sublicenses to its Affiliates and limited sublicenses to its distribution, marketing and/or sales partners, in each case, in compliance with this Agreement.

License Property

Licensor Patents means (a) all Patent Rights relating to methods and processes for glycosylation design and remodeling of proteins, peptides and antibodies that are  Controlled by Licensor, including, but not limited to the Patent Rights listed.
6,800,468 – UDP-galactose: .beta.-N-acetyl-glucosamine .beta.1,3galactosyltransferases, .beta.3Gal-T5
6,995,004 – UDP-N-ACETYLGLUCOSAMINE: GALACTOSE-.beta. 1,3-N-ACETYLGALACTOSAMINE-.alpha.-R / N-ACETYLGLUCOSAMINE-.beta. 1,3,-N-ACETYLGALACTOSAMINE-.alpha.-R (GLCNAC TO GALNAC) .beta.1,6-N-ACETYLGLUCOSAMINYLTRANSFERASE, C2/4GNT
6,635,461 – UDP-N-acetylglucosamine: galactose-.beta.1, 3-N-acetylgalactosamine-.alpha.-R/(GlcNAc to GalNAc) .beta.1,6-N-acetylglucosaminyltransferase, C2GnT3

New Product shall mean the following: (a) any of the Licensee Materials modified using either (i) the Licensor Technology, (ii) any Licensor Improvements, or (iii) any combination of all or some of (i) and (ii) above, and (b) any Licensee Materials covered by any Carved Factor VIII Claims (except to the extent such claims constitute Licensee Improvements).

M1 Profile for the New Factor VIII Product means the parameters for candidate selection required for PEG-F8.

Reagents means the enzymes and sugar nucleotides required to use the Licensor Technology in the manufacture of New Products.

Carved Factor VIII Claims shall mean any Potential Carved Factor VIII Claim with respect to which the parties have filed a separate patent application.

Potential Carved Factor VIII Claims shall mean any composition-of-matter claims and any method of treatment claims that are supported by Patent Rights Controlled by Licensor that (i) do or could explicitly and solely recite and claim Licensee Materials, or (ii) any Licensee Improvements made or reduced to practice by Licensor.

Product-Candidate means any new hemostasis product-candidate Controlled by Licensor during the Term.

Licensor Intellectual Property means Licensor Technology and the Licensor Improvements.

Licensor Technology means the Licensor Patents and any Know-How Controlled by Licensor relating to methods and processes for the glycosylation design and remodeling of proteins, peptides and antibodies, including, without limitation, its GlycoAdvance®, GlycoPEGylation™ and GlycoConjugation™ technologies, and other carbohydrate synthesis processes, and all Know-How resulting from work conducted by Licensor during the Term.

Licensor Improvements means any and all Improvements relating to the Licensor Technology made, conceived, or reduced to practice by (i) either Licensor or Licensee or both in the conduct of the Original Work Plan under the Original Agreement or the Work Plan under this Agreement, (ii) either Licensor or Licensee or both under this Agreement.

GlycoPEG-FVIIa is a long-acting form of recombinant Factor VIIa that is being developed by our partner, Novo Nordisk A/S, utilizing our GlycoPEGylation technology. Factor VIIa is used in the treatment of bleeding episodes and for the prevention of bleeding during surgery or invasive procedures in patients with congenital hemophilia with inhibitors to coagulation Factors VIII or IX.

Field of Use

Licensee is also developing long-acting forms of recombinant Factor VIII and recombinant Factor IX utilizing our GlycoPEGylation technology. Factor VIII products are used in the treatment of Hemophilia A, and Factor IX products are used in the treatment of Hemophilia B.

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 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

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

A Licensor from Germany and a Licensee agree to a joint development program to conduct development, manufacturing and commercialization activities related to Products, and to seek Regulatory Approval of Development Products in the Territory.   This joint development program will optimizes the contributions of each Party to accelerate the beneficial application of a Next Generation G-CSF to address important unmet needs for improved therapeutic products and will be in their mutual and individual best interests.  The parties shall work exclusively with each other, under this Agreement, on the development, manufacturing and commercialization of a Next Generation G-CSF, whether alone or in combination with any other active ingredient; provided, however, that at all times during the term of this Agreement.

Licensee shall have the exclusive right to market and distribute the Commercial Product in the Licensee Territory (United States, Canada, Mexico and Japan).

License Property

Collaboration means the business of developing and commercializing a Product within the Territory, whether conducted directly by Licensor or Licensee or jointly by Licensor and Licensee.

Product means a Development Product or Commercial Product.  

Commercial Product means any Development Product that has received all Regulatory Approvals and any Pricing Approvals required to be obtained prior to marketing and selling such product in any country in the Territory.  

Development Product means a Next Generation G-CSF, whether alone or in combination with another active ingredient, in development under this Agreement.

G-CSF means a molecule having an amino acid sequence identical to the natural human G-CSF, with or without an additional N-terminal methionine, and with or without glycosylation and showing comparable pharmacodynamic/pharmacokinetic profiles to the first generation G-CSF products.

Next Generation G-CSF means a molecule developed by the parties under this Agreement using G-CSF and the Licensee Technology, which molecule has one or more improved or altered pharmacodynamic/pharmacokinetic characteristics compared to G-CSF.

Licensor Technology means any existing or future (i) patent application or issued patent owned or controlled by Licensor in the Territory relating to the development or manufacture of G-CSF, including any addition, continuation, continuation-in-part, division, extension or renewal thereof, (ii) know-how, trade secrets, technical information, formulae, processes and data owned or controlled by Licensor that relate to the composition, design, remodeling, development, manufacture or use of a Product, including, without limitation, preclinical and clinical results, (iii) the rights of Licensor in and to any Trademark, and (iv) all rights of Licensor in and to Joint Technology related to the Product; in each case, to the extent Licensor has the right to license or sublicense any such right to Licensee.

Licensee Technology means any existing or future (i) patent application or issued patent owned or controlled by Licensee in the Territory relating to glycosylation design or remodeling of recombinant proteins and products made using any of Licensee’s GlycoAdvance™, GlycoPEGylation™ and GlycoConjugation™ technologies, including any addition, continuation, continuation-in-part, division, extension or renewal thereof, (ii) know-how, trade secrets, technical information, formulae, processes and data owned or controlled by Licensee which relate to the composition, design, remodeling, development, manufacture or use of the Product, including, without limitation, preclinical and clinical results, (iii) the rights of Licensee in and to GlycoAdvance™, GlycoPEGylation™ and GlycoConjugation™ and any other Trademark, and (iv) all rights of Licensee in and to Joint Technology related to a Product; in each case, to the extent Licensee has the right to license or sublicense any such right to Licensor.

Field of Use

Field means the development of Development Products and commercialization of Commercial Products relating to the drug industry.

The agreement is to co-develop the next generation of a protein used to promote the production of infection-fighting white blood cells.
The Parties will use the GlycoPEGylation technology to develop a long-acting, next-generation version of granulocyte colony stimulating factor (G-CSF), a protein used to stimulate white blood cell production to improve the body's infection-fighting capacity.

License Grant

Included with the supply and option agreement where Licensor grants to The German Licensee an exclusive option, exercisable any time after the date hereof and prior to April 28, 2005, the Option Exercise Date, to enter into a Research, License, and Option Agreement with Licensor; and Licensor grants a sole and exclusive right and option to obtain an exclusive license under the Licensor Technology to develop and commercialize the Product; is the Research, License and Option agreement where Licensor grants to the German Licensee an exclusive, license, or sublicense, under the Licensor Technology that is useful for the Product in the Field to make, have made, use, sell, offer to sell and import the Product in the Field in the Territory and to make, have made and use Reagents in the Territory solely for the purpose of making and having made the Product.  The licenses granted shall include a right to grant Sub licenses.

License Property

The certain intellectual property rights relate to the development of next-generation erythropoietin products.

Licensors Technology means any existing or future Patent Rights owned or controlled by Licensor in the Territory relating to glycosylation design or remodeling of CHO-EPO made using any of Licensors GlycoAdvanceâ„¢, GlycoPEGylationâ„¢ and GlycoConjugationâ„¢ technologies, know-how, trade secrets, technical information, formulae, processes and data owned or controlled by Licensor which relate to the composition, design, remodeling, development, manufacture or use of CHO-EPO; the rights of Licensor in and to GlycoAdvanceâ„¢, GlycoPEGylationâ„¢ and GlycoConjugationâ„¢ and any other trademark, and all rights of Licensor in and to any Improvements related to CHO-EPO; in each case, to the extent Licensor has the right to license or sublicense any such right to Licensee.

The Product means the Next Generation CHO-EPO, whether alone or in combination with another active ingredient, that is developed and commercialized by Licensee.

CHO-EPO means EPO produced in Chinese hamster ovary cells.   EPO means a molecule having an amino acid sequence and showing pharmacodynamic/pharmacokinetic profiles similar to the first generation erythropoeitin products.

Field of Use

The Field means any and all erythropoeitic indications.  Licensee use of the protein is only for research commenced by Licensor to identify a lead CHO-Xxpressed EPO candidate for development using any of its GlycoAdvanceâ„¢ and GlycoPEGylationâ„¢ technologies;  to only distribute the Protein delivered pursuant to this Agreement or any formulation of such Protein to third parties for the sole purpose of conducting such research and will not distribute the Protein delivered pursuant to this Agreement or any formulation of such Protein to any other third party without Licensees prior written consent, and will not administer the Protein delivered pursuant to this Agreement or any formulation of such Protein to any human.

Erythropoietin (also known as EPO) is a growth factor that stimulates the production of red blood cells. Most of the cells in the blood are red blood cells, whose main function is to carry oxygen throughout the body. Erythropoietin is used to treat anemia resulting from kidney failure or cancer treatment.

License Grant

Licensor grants to the Swiss Licensee a worldwide, exclusive, even as to Licensor, license under the Licensor IP to research, develop, make, have made, use, import, have sold, sell and offer to sell Licensed Products.

License Property

The intellectual property is in respect to Recombinant Factor XIII and related preclinical and clinical studies.

Patent Product means a product that contains Recombinant Factor XIII, the making, using, importation, exportation, offer for sale or sale of which product would infringe, in the absence of the licenses granted under this Agreement, any unexpired Patent Claim.

Recombinant Factor VIIa and rFVIIa mean a protein that has an amino acid sequence of human factor VIIa or its subunits and that is produced by recombinant DNA techniques (including without limitation, production in prokaryotic and eukaryotic host cells and transgenic animals), including variants, derivatives, modifications, fragments, hybrids, mutants, conjugates, fusion proteins and analogs of such protein. Recombinant Factor VIIa and rFVIIa shall mean the active Factor VIIa protein in Licensee’s product known as NovoSeven®.

Recombinant Factor XIII and rFXIII mean a protein that has an amino acid sequence of human factor XIII or its subunits, or any combination thereof, and that is produced by recombinant DNA techniques, including, without limitation, production in prokaryotic and eukaryotic host cells and transgenic animals, including variants, derivatives, modifications, fragments, hybrids, mutants, conjugates, fusion proteins and analogs of such protein.

NovoSeven (coagulation factor viia recombinant) is a vitamin K-dependent glycoprotein consisting of 406 amino acid residues (MW 50 K Dalton). NovoSeven (coagulation factor viia recombinant) is structurally similar to human plasma-derived Factor VIIa.

Field of Use

The field of use is Cancer Treatment or Cardiac Surgery.

Cancer Treatment Indication means bleeding in a patient with malignancy that occurs either as a consequence of the malignancy or the treatment of the malignancy and requires medical intervention.

Cardiac Surgery Indication means bleeding or oozing of blood in a patient undergoing cardiac surgery or having undergone cardiac surgery that occurs during or following the surgery and requires medical intervention.

NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) is used for:
– Treatment of bleeding and prevention of bleeding for surgeries and procedures in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and people with Glanzmann’s thrombasthenia who have a decreased or absent response to platelet transfusions
– Treatment of bleeding and prevention of bleeding for surgeries and procedures in adults with acquired hemophilia

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.