Royalty Report: Drugs, Therapeutic, Proteins – Collection: 224408

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

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

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

Licensor agree to a joint development program with a German Licensee 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 (all countries of the world except the 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 (granulocyte colony stimulating factor) 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 Licensor 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 glycosylation design or remodeling of recombinant proteins and products made using any of Licensor’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 Licensor 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 Licensor in and to GlycoAdvance™, GlycoPEGylation™ and GlycoConjugation™ and any other Trademark, and (iv) all rights of Licensor in and to Joint Technology related to a Product; in each case, to the extent Licensor has the right to license or sublicense any such right to Licensee.

Field of Use

Field means the development of Development Products and commercialization of Commercial Products.

G-CSF is prescribed to stimulate production of neutrophils (a type of white blood cell), and is approved for sale in major markets around the world for treatment of neutropenia associated with oncology chemotherapy.

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

The Japanese Licensor hereby grants to Licensee a sole and exclusive license to all G-CSF Technology solely for use in the manufacture and marketing of G-CSF Products in Europe.

License Property

G-CSF Technology shall mean (i) pluripotent human granulocyte colony stimulating factor which includes the gene, host vector systems, and G-CSF producing cells including microorganisms used for G-CSF expression, and all proprietary technical information, technology, know-how and patents related to G-CSF, natural sources of G-CSF and any G-CSF materials purified from natural sources, and (ii) the commercial production system (an established in vivo assay system and commercially viable expression system which will enable the achievement of a high level of expression and purification to produce sufficient materials for commercial development and marketing) for the manufacture of G-CSF Products.

License Grant

The Licensor hereby grants a sole and exclusive license to all G-CSF Technology to (i) use, modify and improve the G-CSF Technology, and (ii) develop, make, have made, sell and use G-CSF Products within the Territory, to the Licensee.

License Property

G-CSF shall mean a glycoprotein molecule consisting of the linear array of amino acids, or any variation thereof consisting of additions, deletions or substitutions of up to ten amino acids.

Field of Use

The rights granted apply for human pharmaceutical use.

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.