Royalty Report: Drugs, Disease, Technical Know How – Collection: 147899

License Grant

The Licensor grants to Licensee a nonexclusive, worldwide, noncancellable right and license to use and have used, for the sole purpose of testing compounds, (i) Existing Synaptic Technology, Project Technology and the 5-HT4 Receptors, the cDNA encoding such receptors, the cell lines expressing such receptors and, to the extent related to such receptors, binding assays and functional assays and (ii) all SYNAPTIC patent rights which would be infringed by Licensee's exercise of the right and license referred to in the foregoing clause (i); provided, however, that such right and license does not extend to the use of either of the aforementioned Technologies or the 5-HT4 Receptors and the aforementioned related materials and technology for the purpose of the screening, identification, selection and/or development of any compound the mechanism of action of which involves a 5-HT4 Receptor and does not involve a Project Receptor.'

The Licensor and the Licensee have collaborated in a research effort directed at certain serotonin (5-  hydroxytryptamine  or 5-HT)  receptors and  5-HT-related disorders. Receptors are targets for the treatment of GI motility disorders.

License Property

The Licensor will assess Licensee Compounds at Project Receptors and at the 5-HT4  Receptors  in  binding  and functional  assays,  tissue localization  studies involving Project Receptors, the conduct  of neurotransmitter release studies involving Project Receptors and  5-HT4 Receptors and the identification of new species homologues of Project  Receptors.

'5-HT4 Receptor' means any 5-HT4 receptor that is disclosed in U.S. Letters Patent No. 5,472,866 entitled 'DNA Encoding 5-HT4a Receptors' and PCT International Application entitled 'DNA Encoding 5-HT4 Serotonin Receptors and Uses Thereof,' published as WO 94/14957.

License Grant

The parties agreed to modify certain terms and conditions contained in the Current Agreement relating to the collaboration in a research effort directed at certain serotonin (5-hydroxytryptamine or 5-HT) receptors and 5-HT- related disorders.

License Property

The modified terms and conditions include but not limited to.

Modification of Definition for Project
Project means (i) with respect to the period beginning on January 25, 1991, and ending on December 31, 1994,  the research and development program conducted by Licensor in the Field in collaboration with Licensee during  such  period and (ii) with respect to the period beginning on January 1, 1995, the continuation of such program; provided, however, that from and after January 1, 1995, such program shall be limited to the continued  provision by Licensor to Licensee of support in (A) the evaluation by Licensor of Licensee Compounds at Project Receptors and at the 5-HT4 Receptors in binding and functional assays, (B) tissue localization studies involving Project Receptors. (C) the conduct of neurotransmitter release studies involving Project Receptors and 5-HT4 Receptors and (D) the identification of new species homologues of Project Receptors, all in accordance with Sections 2.00, 2.01 and 5.00 and to the extent that Licensees license shall not have  terminated pursuant to Section 6.02; provided further, however, that such program may be expanded to include Licensor chemistry resources as contemplated by section 7.00.

Addition of New Defined Terms
Library Compound means any Existing Licensee Compound or New Compound included within a Licensee Library.

Licensee Library means any compound library which (i) Licensee, or an Affiliate thereof, owns or otherwise has access to and (ii) is subject to high volume screening in assays using Existing Licensor Technology, Project Technology and/or 5-HT4 Receptors at Licensees Affiliate, Sphinx Pharmaceuticals, or at other mutually agreed sites.

5-HT4 Receptor means any 5-HT4 receptor that is disclosed in U.S. Letters Patent No. 5,472,866  entitled 'DNA Encoding 5-HT4a  Receptors' and PCT International Application entitled 'DNA Encoding 5-HT4 Serotonin Receptors and Uses Thereof,' published as WO 94/14957.

U.S. 5,472,866 – DNA encoding 5-HT.sub.4A serotonin receptors

Amended section From January 1, 1995, through December 31, 1996, Licensor shall devote a minimum of ten Scientific Man Years per year to the Project. From and after January 1, 1997, during the term of the Project,  Licensor shall devote a minimum of twenty-two Scientific Man Years per year to the Project, at least four of which shall be provided by scientists with Ph.D. degrees.

Field of Use

Field of use is for the treatment used to stimulate upper gut, motility and prevent nausea and vomiting.

License Grant

Licensor hereby grants to Swiss Licensee the following licenses (i)  during the Project Term and the Post-Project Term an exclusive, worldwide license to use, for the sole purpose of discovering and/or developing Project Compounds to be employed for Project Uses, all Licensor Project Technology and Assays and all Licensor Patent Rights which would be infringed by the exercise by Licensee of its rights under this Agreement, subject to the reservation in favor of Licensor of the right to use all the said Project Technology, Assays and Patent Rights for the purposes of this Agreement and for other purposes not falling within the scope of the license hereby granted; and  (ii) following the Post-Project Term, a non-exclusive, worldwide, license to use, for the sole purpose of identifying or discovering and developing compounds to be employed for Project Uses and negative testing of compounds for Project Uses, all such Licensor Project Technology and Assays and all Licensor Patent Rights which would be infringed by Licensees exercise of its rights under this Agreement.  Such license shall be royalty-free unless the compound being developed is a Project Compound, in which case royalties shall be payable in respect of such Project Compound in accordance with the provisions of this Section 6. (iii)  an exclusive, worldwide, royalty-bearing license under Licensors Patent Rights for the life of those patents to manufacture, have manufactured, use and sell Products developed from Project Compounds or Project Technology identified or discovered during the Project Term or existing as at the Effective Date.

License Property

Product means any commercial form of a Project Compound (including, specifically, acids, esters, salts and pro-drug forms, enantiomers, metabolites, solvates, polymorphs and special formulations) or Project Technology, including diagnostic testing services and/or products, made, used or sold for a Project Use.

Project Compound means any chemical entity which interacts directly with an ob Gene-related Target and which already exists or which is synthesized, identified or licensed by Licensee and/or Licensor, either jointly or independently, and the further development of which for a Project Use is commenced by Licensee during the Project Term or the Post-Project Term.

Assay means a proprietary assay for any ob Gene-related Target or combination of such Targets which exists at the Effective Date, or which is developed during the term of this Agreement as part of the Project and which can be employed to screen compounds for their ability to interact directly with ob Gene-related Targets.

Field of Use

Field means the cloning, expression and characterization of ob Gene-related Targets, the development and use of assays for identifying and studying compounds which interact directly with ob Gene-related Targets, and the design and development of such compounds as Products.

Project Use means and includes the treatment in humans of eating or metabolic disorders, or obesity, and/or the diagnosis of any such disorders or conditions.

License Grant

For the option, Licensor grants to Licensee of the United Kingdom, upon exercise of the Option, throughout  the  territory, for the sole purpose of developing, making, having made, using and selling  BPH products, a non-exclusive license under the patents.

For the Licenses, Licensor grants throughout the territory, for the sole purpose of developing, making, having made, using and selling selective Alpha-1 an Adrenergic Receptor Products which are not BPH Products, a non-exclusive license under any of the Receptor patents. The section of the license grant shall extend back in time to apply to acts by Licensee prior to the Effective Date of this agreement.

Licensor grants, throughout the Territory, for the sole purpose of developing, making, having made and using but not selling BPH Products a nonexclusive license under the Receptor Patents.

Licensor grants, throughout the Territory, for the sole purpose of developing, making, having made and using but not selling BPH Products a nonexclusive license under the Functional Use Patents.

Upon exercise of the Option, Licensor grants throughout the Territory, for the sole purpose of developing, making, having made, using and selling BPH Products a non-exclusive license under the Patents.

License Property

Licensor possesses patent rights pertaining to the use of selective human alpha-1a adrenergic receptor compounds which may be useful for the  treatment of benign prostate hyperplasia (BPH) and other medical conditions and cloned human alpha-1a, -1b and -1d adrenergic receptors.

BPH Compound shall mean any Selective Alpha-1a  Adrenergic Receptor Compound for which regulatory approval to sell for the treatment of BPH or for the  inhibition of  contraction  of prostate  tissue has been obtained or is being sought.

BPH Product shall mean any prescription or over-the-counter pharmaceutical preparation containing BPH  Compounds for use in humans.

Human Alpha-1 Adrenergic Receptors shall mean alpha-1a , alpha-1b, and, alpha-1d.

Selective Alpha-1 Adrenergic Receptor Product shall mean any prescription or over-the-counter pharmaceutical preparation containing Selective Alpha-1a Adrenergic Receptor Compounds for use in human or non-human animals.

Field of Use

Alpha-1a adrenergic receptor compounds may be useful for the  treatment of benign prostate hyperplasia (BPH).

The Therapeutic indication shall mean,  with respect to any Selective Alpha-1a Adrenergic Receptor Product, the main therapeutic use as classified in the 2nd level of the World Health Organization Anatomical, Therapeutic, Clinical (ATC) drug classification system.

Licensee is developing  selective human alpha-1a  adrenergic receptor  compounds  which may be useful for the  treatment of BPH and other medical conditions and is using cloned human alpha-1 adrenergic receptors.

License Grant

For the license grant for Exclusive Screens Licensor grants an exclusive right and license, under the Technology, Patents and Know-How, to use and practice the Exclusive Screens, including, without limitation, the right to grow sufficient amounts of Materials provided by Licensor to Licensee.

For the license grant for Non-Exclusive Screens, License grants an exclusive right and license, under the Technology, Patents and Know-How, to use and practice Non-Exclusive Screens, including, without limitation, the right to grow sufficient amounts of Materials provided by Licensor to Licensee, during the term of the Research Programs, but in no event for less than nine months after Licensee receives Materials and other information from Licensor identifying and enabling Licensee to use such Non-Exclusive Screen.

License Property

Licensor has the exclusive rights to certain technology involving the transfection and expression of G-protein- coupled receptors into yeast.  Licensor exploits similarities between the yeast and human genome to identify new drug discovery targets.

The Autocrine System shall mean that part of Licensors Technology whereby any yeast cells into which human Receptors have been inserted and grow in response to compounds produced and secreted by the same yeast cells.

Compound shall mean any Lead Compound or any Analog of any Lead Compound.

Receptor shall mean any human, G-protein-coupled, seven transmembrane receptor (including, without limitation, genes, vectors and cDNAs), and shall include any Licensee Receptor or Other Receptor.

Licensee Receptor shall mean a Receptor which is proprietary to Licensee and is provided by Licensee to Licensor for use in the Research Programs, or a Receptor which is proprietary to Licensee and is cloned or obtained by Licensor pursuant to research performed under the Research Programs, or a Receptor provided by Licensee to Licensor for use in the Research Programs which is deemed to be a Licensee Receptor.

Technology shall mean all inventions, improvements, discoveries, claims, formulae, processes, trade secrets, technologies, Patents and Know-How owned by Licensor or to which Licensor has the rights to grant licenses or sublicenses, and relating to or derived from Licensors yeast-based, human G-protein-coupled receptor technology, or the Research Programs.

The Patents are titled
Expression of G Protein Coupled Receptors in Yeast, Yeast-Based Peptide Libraries for identification of G Protein-Coupled Receptor Agonists and Antagonists, and, Functional Expression of Mammalian Adenylyl cyclase in Yeast.

Field of Use

The field of use is screening assays.

Licensee recognizes that the technology represents a valuable source of development of screening assays for the discovery of potential products for manufacture, use and sale in the Territory.