Royalty Report: Drugs, Disease, Therapeutic – Collection: 291131

License Grant

Licensor hereby grants to Licensee an exclusive (even as to Licensor), royalty-bearing license in the Territory, with the right to sublicense through multiple tiers of sublicense, under Licensor’s interest in Collaboration Technology and Joint Technology, solely (A) to perform Licensee’s obligations under the Research Program during the Research Term and (B) to develop, make, have made, use, sell, have sold, offer for sale and import Development Candidates and Products in the Field during the Term; provided, however, that Licensor retains such rights under Licensors interest in Collaboration Technology and Joint Technology solely as are necessary to perform its obligations under the Research Program.

Licensor hereby grants to Licensee a non-exclusive, royalty-bearing license in the Territory, without the right to sublicense (except that Licensee may subcontract), under Licensor Technology Controlled by Licensor solely to perform Licensee’s obligations under the Research Program during the Research Term, and (B) Licensor hereby grants to Licensee a non-exclusive, royalty-bearing license in the Territory, with the right to sublicense as described below through multiple tiers of sublicense, under Licensor Technology Controlled by Licensor solely to develop, make, have made, use, sell, have sold, offer for sale and import Development Candidates and Products in the Field during the Term.

Licensor hereby grants to Licensee, a non-exclusive, royalty-bearing (included within the royalties as set forth) in license in the Territory, including the right to sublicense as described below through multiple tiers of sublicense, under such Specific Claims solely to develop, make, have made, use, sell, offer for sale, have sold or import such Development Candidate in the Field during the Term.

License Property

Product shall mean any preparation in final form containing a Development Candidate for sale by prescription, over-the-counter or any other method.

Joint Technology shall mean Joint Inventions and Joint Patents. Joint Patents shall mean Patents claiming any Joint Invention. Joint Invention shall mean any Invention conceived jointly by the Parties (or on their behalf) in the course of the Research Program during the Research Term; but excluding, in each case, Collaboration Technology, Licensee Technology and Licensor Technology.

Collaboration Technology shall mean Collaboration Know-How and Collaboration Patents.
Collaboration Patents shall mean Patents first filed after the Effective Date with claims or portions thereof, to the extent that they describe or claim a Collaboration Compound or a method of making or using a Collaboration Compound, where such Invention is conceived solely by a Party (or on its behalf) or jointly by the Parties (or on their behalf) in the course of the Research Program during the Research Term; provided that any Patent with the same disclosure as an Licensee Patent described in Agreement or a Licensor Patent described in Agreement, such as a renewal, division, continuation (in whole), or request for continued examination (RCE), reissue, reexamination or the like, will be included, as applicable.

Licensee Patents shall mean (a) Patents with claims or portions thereof, to the extent directed to any Invention that is an Licensee Nucleoside or Collaboration Compound or a method of making or using an Licensee Nucleoside or Collaboration Compound, where such Patents are Controlled by Licensee as of the Effective Date, (b) Patents with claims or portions thereof, to the extent directed to any Invention that is an Licensee Nucleoside or a method of making or using an Licensee Nucleoside, where such Invention first becomes Controlled by Licensee during the Research Term (provided that any such Patent with the same disclosure as a Patent described in subsection (a), such as a renewal, division, continuation (in whole), or request for continued examination (RCE), reissue, reexamination or the like, will be included in subsection (a) rather than subsection (b)) and (c) Patents with claims or portions thereof, to the extent directed to any Invention that is a Collaboration Compound or a method of making or using a Collaboration Compound, where such Invention first becomes Controlled by Licensee after the Research Term but prior to the First Commercial Sale of any Product that contains such Collaboration Compound.  Notwithstanding the foregoing, subsection (b), does not include any claims of such Patents or portions thereof to the extent directed to any such Invention that is a Collaboration Compound or a method of making or using a Collaboration Compound.  For purposes of clarity, Licensee Patents do not include Licensor Patents.  The Licensee Patents existing on the Effective Date are listed.
6,395,716 – .beta.-L-2-deoxy-nucleosides for the treatment of hepatitis B
6,569,837 – .beta.-L-2-deoxy pyrimidine nucleosides for the treatment of hepatitis B
6,914,054 – Methods and compositions for treating hepatitis C virus

Collaboration Compound shall mean a chemical entity that is synthesized solely by a Party or jointly by the Parties (or on behalf of a Party or the Parties) in the course of the Research Program during the Research Term that covalently incorporates HepDirect Technology and is converted into an Licensee Nucleoside (including any monophosphate, diphosphate or triphosphate thereof) in the body.

Combination Therapy shall mean a fixed dose product containing more than one (1) active pharmaceutical ingredient.  Separate products that are sold or promoted for sale together for co-administration shall not be considered a Combination Therapy.

Licensor Technology shall mean the Licesor Know-How and Licensor Patents.
Licensor Patents shall mean (a) Patents with claims or portions thereof, to the extent directed to any Invention that is HepDirect Technology or Collaboration Compound or a method of making or using HepDirect Technology or a Collaboration Compound, where such Patents are Controlled by Licensor as of the Effective Date, and (b) Patents with claims or portions thereof, to the extent directed to any Invention that is HepDirect Technology or a method of making or using HepDirect Technology, where such Invention first becomes Controlled by Licensor during the Research Term (provided that any such Patent with the same disclosure as a Patent described in subsection (a), such as a renewal, division, continuation (in whole), or request for continued examination (RCE), reissue, reexamination or the like, will be included in subsection (a) rather than subsection (b)).  Notwithstanding the foregoing, subsection (b) does not include any claims of such Patents or portions thereof to the extent directed to any such Invention that is a Collaboration Compound or a method of making or using a Collaboration Compound.  For purposes of clarity, Licensor Patents do not include Licensee Patents.  

Development Candidates for purposes of this Agreement means a designate one (1) or more Collaboration Compounds that possess the properties specified to the Research Plan.

HepDirect Technology shall mean (a) (i) any and all cyclic 1,3-propanyl esters or amides of phosphates, phosphoramidates and/or phosphonates that re activated by any P450 enzyme and/or (ii) any method of making or using any of the foregoing (this clause (a), “HepDirect Base Technology”); which (b) are the subject matter as originally claimed in the Licensor Core Patents as of the Effective Date or as claimed in any amendment filed in the Licensor Core Patents.

Field of Use

Field shall mean the treatment of chronic hepatitis C viral infections in humans.

License Grant

Licensor grants an exclusive, even as to Licensor, license, with the right to sublicense, under Licensors interest in Collaboration Patents, and Collaboration Know-How, in each case solely to develop, make, have made, use, sell, have sold, offer for sale and import Products in the Field in the Territory; provided, however, that Licensor retains such rights under Collaboration Technology as are necessary to perform its obligations under the Research Program.

This agreement also includes Non-Exclusive Cross-Licenses where each Party hereby grants to the other Party a non-exclusive, royalty-free license, without the right to sub-license
(i) under such Partys interest in Collaboration Know-How for the manufacture or formulation of products other than Products, including 'cocktail' and other Combination Products; and
(ii) under such Partys interest in Collaboration Know-How, solely to conduct research in the HCV Field in the Territory.

License Property

Licensor has a research program for the discovery and optimization of nucleoside inhibitors of the NS5b polymerase in hepatitis C virus.

The Collaboration Compound shall mean a Nucleoside that satisfies the chemical and technical requirements set forth, and its Related Compounds and which
(a) is or was synthesized by or for Licensor on or before the Effective Date or during the Research Program Term; or
(b) is a Related Compound to a Collaboration Compound disclosed by Licensor to Licensee pursuant to Identification and Contribution of Collaboration Compounds and which is synthesized by or for Licensee after the Effective Date.

The Collaboration Compound Products shall mean any preparations in final form, bulk form or other form containing as an active pharmaceutical ingredient one or more Selected Compounds.

Field of Use

The Field shall mean all human and animal therapeutic, diagnostic, and prophylactic uses, including, without limitation, the treatment, prevention and prophylaxis of hepatitis C viral infections.

The HCV Field shall mean the treatment of chronic hepatitis C viral infections in humans.

The Collaboration Compound Products are for sale by prescription, over-the-counter or any other method, including without limitation any Combination Product.

License Grant

License to Commercialize Collaboration Compounds –  Licensor grants to Licensee a worldwide, exclusive license, with the right to sublicense, under the Licensor IP and Licensors interest in the Collaboration IP, to make, have made, use, sell, offer to sell and import Collaboration Compounds, and/or Collaboration Products based on such Collaboration Compounds, for any and all uses and indications in the Licensee Field.

License to Compounds (Other than Collaboration Compounds)  Derived from Licensee Compounds – Licensor grants to Licensee a worldwide, exclusive license, with the right to sublicense, under the Licensor IP and Licensors interest in the Collaboration IP, to make, have made, use, sell, offer to sell and import Collaboration Compounds, and/or Collaboration Products based on such Collaboration Compounds, for any and all uses and indications in the Licensee Field.

License Property

Collaboration Product shall mean a pharmaceutical product containing a Collaboration Compound that is sold by Licensee or Licensor, or their respective Sublicensees or Affiliates.  It is understood that, in the event any Collaboration Compound is sold for therapeutic purposes, such Collaboration Compound shall be deemed a Collaboration Product and shall be subject to milestones and royalties as set forth in this Agreement.

Collaboration Compound shall mean a Licensor Compound or a Non-Exclusive Compound or a compound that is derived, directly or indirectly, from a Licensee Compound, Licensor Compound, or Non-Exclusive Compound; in each case, that modulates the biological activity of a Collaboration Target at a level of potency to be established by the JRC.  A compound shall be deemed to have been derived directly from another compound if it (i) is the result of a chemical modification made to such a compound, (ii) is otherwise obtained from a chemical synthesis program based on one or more such compounds, (iii) is based on proprietary structure-activity data obtained from the testing of one or more such compounds, or (iv) is specifically or generically within the scope of one or more claims of any patent application or patent filed by Licensor or Licensee or their Affiliates to protect any compound in category (i), (ii) or (iii) above.  A compound shall be deemed to have been derived indirectly from another compound if it is the result of a series of iterations of any or all of (i) through (iv) above.  For purposes of clarity, any compound synthesized in the course of the Collaboration and based on a Licensee Compound, Licensor Compound, or Non-Exclusive Compound which is active against a Collaboration Target at the level of potency established by the JRC shall be deemed a Collaboration Compound.  Joint Research Committee or “JRC” shall mean the entity organized to manage the scientific implementation of the Collaboration.

Licensee IP shall mean Licensee Patents and Licensee Know-how.

Collaboration IP shall mean Collaboration Patents and Collaboration Know-how.  Collaboration IP shall not include Licensor IP or Licensee IP.

Licensor IP shall mean Licensor Patents and Licensor Know-how.  Licensor IP shall not include any intellectual property owned or licensed by Licensor or its Affiliates relating to the ECLiPSâ„¢ technology (i.e., the creation or use of encoded combinatorial libraries or any tag and/or marker compounds).

Licensee Patents shall mean all Patents in the Territory Controlled by Licensee or its Affiliates as the effective date, or any other Patent Controlled by Licensee during the Term; in each case, necessary for the discovery, development, manufacture, importation or use of one or more Collaboration Compounds and/or the development, manufacture, use, sale, importation or commercialization of corresponding Collaboration Products.

Licensor Patents shall mean all Patents in the Territory Controlled by Licensor or its Affiliates as the Effective Date, or any other Patent Controlled by Licensor during the Term; in each case, necessary for the discovery, development, manufacture, importation or use of one or more Collaboration Compounds and/or the development, manufacture, use, sale, importation or commercialization of corresponding Collaboration Products.

Collaboration Patents shall mean (i) all patents and patent applications claiming any invention or discovery which was conceived or reduced to practice during the Collaboration Term and in the course of the Collaboration, by employees or agents of Licensee, Licensor or any of their respective Affiliates, either alone or jointly (including, without limitation, the synthesis and composition of matter of any Collaboration Compound, or method of use thereof; and (ii) any divisions, continuations, continuations-in-part, reissues, reexaminations, extensions or other governmental actions which extend any of the subject matter of the patent applications or patents in (i) above, and any substitutions, confirmations, registrations, revalidations, or additions of any of the foregoing, in each case, which is owned or Controlled, in whole or part, by license, assignment or otherwise by Licensor or Licensee during the term of this Agreement; provided, however, that Collaboration Patents shall not include any Licensee Patents or Licensor Patents.

Licensor Compound shall mean any compound brought to the Collaboration by Licensor, which is Controlled by Licensor at or after the Effective Date, and which is proprietary to Licensor by virtue of being within the Licensor IP.

Field of Use

The primary objective of the alliance is to identify active molecules and bring them forward to clinical proof of concept, yielding novel candidates for drug development in various therapeutic areas.

Licensor Field shall mean, with respect to each Collaboration Compound for which Licensor has received approval to develop pursuant, all human and animal disorders and diseases treated by modulation of a Collaboration Target by such Collaboration Compound.

Licensee Field shall mean, with respect to each Collaboration Compound, all human and animal disorders and diseases treated by modulation of a Collaboration Target by such Collaboration Compound.

License Grant

This agreement is a research collaboration to apply Licensor Technology to Licensee HCV Compounds to develop the Collaboration Compounds.

For the License under Prior Technology and Collaboration Technology, Licensor grants to Merck an exclusive, even as to Licensor, license, with the right to sublicense, under Licensors interest in Prior Technology and Collaboration Technology solely to perform Licensees obligations under the Research Program during the Research Program Term and to develop, make, have made, use, sell, have sold, offer for sale and import Collaboration Compounds and Products in the Field in the Territory.

For the License under Licensor Technology, Licensor grants a non-exclusive license, with the right to sublicense as described below, under Licensors interest in Licensor Technology solely to perform Licensees obligations under the Research Program during the Research Program Term and to develop, make, have made, use, sell, have sold, offer for sale and import Collaboration Compounds and Products in the Field in the Territory.

For the Limited License Grant, Licensor grants, effective at the time such determination is made, to the extent Licensor is then legally able to do so, a non-exclusive license, including the right to sublicense as described below, under the HCV Claims solely to develop, make, have made, use, sell, offer for sale, have sold or import Collaboration Compound(s) and Product(s) in the Field in the Territory.

License Property

Licensor has developed Licensor Technology for the discovery and optimization of liver targeted compounds.

Licensor technology, know-how and patents relate to HepDirect Technology.

Field of Use

The Field shall mean the treatment of hepatitis C viral infections in humans.

License Grant

Licensor hereby grants to Licensee a permanent, worldwide, exclusive (even as to Licensor) license under Licensors interest in the Licensee Research Patents and Licensee Research Know-How, for any and all purposes; provided, however, that Licensor may exercise such interest solely as necessary to perform its obligations under the Research Program.

Licensor hereby grants to Licensee a worldwide, exclusive license under Licensors interest in the Collaboration Technology to develop, make, have made, use, import, offer for sale, sell, have sold or otherwise exploit (i) Development Candidates for any and all purposes in the Field; and (ii) Licensee-Derived Compounds outside the Field; in each case, alone or as incorporated into a Product.

Licensor hereby grants to Licensee a worldwide, exclusive license under the Licensor Prior Aspartyl Protease Patents to develop, make, have made, use, import, offer for sale, sell, have sold or otherwise exploit Development Candidates for any and all purposes in the Field, alone or as incorporated into a Product.

Licensor hereby grants to Licensee a worldwide, non exclusive license (i) under the Licensor Core Technology and Licensor Know-How as reasonably necessary or useful to develop, make, have made, use, import, offer for sale, sell, have sold or otherwise exploit Development Candidates for any and all purposes in the Field, and (ii) under the Licensor Know-How as reasonably necessary or useful to develop, make, have made, use, import, offer for sale, sell, have sold or otherwise exploit Licensee-Derived Compounds outside the Field; in each case, alone or as incorporated into a Product.  It is understood that the foregoing license under Licensor Core Technology shall not include the right to practice Licensor Core Technology to discover novel compositions outside the Field, and shall only include the right to exploit Development Candidates that are Licensor-Derived Compounds, or that are Licensee-Derived Compounds generated without the use of Licensor Core Technology in accordance with this Agreement.

License Property

Licensee Research Patents shall mean all patents, patent applications and invention disclosures the subject of which is an invention made (i) solely by Licensee personnel in the course of performing the Research Program; or (ii) solely by Licensee personnel during the Exclusivity Period in the course of activities directed to the discovery, research or development of compounds for use in the Field; as well as any divisions, continuations, continuations-in-part, reissues, reexaminations, extensions, supplementary protection certificates, and other governmental actions which extend any of the patent applications or patents in (i) or (ii) above, and all foreign counterparts to any of the foregoing.

Licensee Research Know-How shall mean any information or material, including, but not limited to, discoveries, processes, methods, protocols, formulas, data, non- patented inventions, know-how, and trade secrets of Licensee, made or developed (i) solely by Licensee personnel in the course of performing the Research Program; or (ii) solely by or under authority of Licensee personnel during the Exclusivity Period in the course of activities directed to the discovery, research or development of compounds for use in the Field.

Collaboration Technology shall mean all Research Patents and Research Know-How.
Development Candidate shall mean any Collaboration Compound that is approved by Licensee in its sole discretion as a Development Candidate.

Collaboration Compound shall mean any chemical entity that is a protein, small molecule, or other compound that is synthesized by the Parties pursuant to work conducted under the Research Program and during the Research Term and Derivatives (as defined below) synthesized by a Party or its Affiliates on behalf of a Party prior to the third (3rd) anniversary of the end of the Research Term, and shall include any Licensee-Derived Compound or Licensor-Derived Compound, as the case may be.

Licensor Prior Aspartyl Protease Patents shall mean all patents and patent applications controlled by Licensor as of the Effective Date that claim small molecule inhibitors of Aspartyl Proteases, together with any divisions, continuations, continuations-in-part, reissues, reexaminations, extensions, supplementary protection certificates, and other governmental actions which extend any of the patent applications or patents listed, and any all foreign counterparts of any of the foregoing.

Licensor Prior Aspartyl Protease Patents

SU-2400 P1 – Aspartyl Protease Inhabitors
SU-2499 P2 – Aspartyl Protease Inhabitors
SU-2600 P1 – Constructs for Homogeneously Processed Preparations of Beta Site APP-Cleaving Enzyme

Licensor will contribute an initial series of small molecule inhibitors and apply its proprietary fragment-based drug discovery 'Tethering' technology, a process in which the target selects fragments with binding affinity for a specific region on the target surface, to discover additional novel series of small molecules. The initial target in the collaboration is BACE ;-amyloid precursor protein-cleaving enzyme), an enzyme that mediates the deposition of amyloid plaque in the brain.

Field of Use

This agreement pertains to the drug industry relating to the field that shall mean the research, development and commercialization of Collaboration Compounds for any or all therapeutic indications of small molecule modulators of the Target.

The research collaboration agreement  is to discover novel oral therapeutics for the treatment of Alzheimer's disease.

License Grant

The licenses granted include the right of each licensee to use its Affiliates in exercising such rights and carrying out its obligations under this Agreement.

Licensor hereby grants to Licensee the exclusive (except as to Licensor to permit it conduct its Co-Funded Development and/or Co-Commercialization activities and those activities under the ITMN-191 Transition Plan hereunder) license under the Licensor Know-How and Licensor Patent Rights and under Licensor’s rights in Joint Know-How and Joint Patent Rights to develop, make, have made, use, import, export, offer for sale and sell Licensed Compounds and Products in the Territory.

License Property

ITMN-191 shall mean that Macrocycle identified within Licensee as ITMN-191, together with its salts and esters, which is hereby designated a Licensed Compound.

Macrocycle shall mean any cyclic macromolecule in the Field containing a substituted proline moiety and optional Pl and P3 groups as part of the backbone ring and supporting the attachment of Pl and P4 groups.

Licensee Patent Rights shall mean any and all patents and patent applications in the Field in the Territory which are Controlled by Licensor during the term of this Agreement which Cover any activity permitted under this Agreement, all to the extent that the subject matter claimed therein is used in the course of performing any activity permitted under this Agreement, including, but not limited to, the making, using, selling, offering to sell, exporting or importing Lead Compound, Licensed Compounds, Products, Passed Compounds or Reverted Compounds. For the purposes of this Agreement, “patents and patent applications” shall be deemed to include certificates of invention and applications for certificates of invention, as well as divisions, continuations, continuations-in-part, reissues, renewals, extensions, supplementary protection certificates, and the like of any such patents and patent applications and foreign equivalents thereof.

Joint Patent Rights shall mean any and all patents and patent applications in the Field in the Territory which are invented jointly during the term of this Agreement by employees of both Parties according to the U.S. laws pertaining to joint inventorship. For the purposes of this Agreement, “patents and patent applications” shall be deemed to include certificates of invention and applications for certificates of invention, as well as divisions, continuations, continuations-in-part, reissues, renewals, extensions, supplementary protection certificates, and the like of any such patents and patent applications and foreign equivalents thereof.

Licensed Compound shall mean (a) ITMN-191 and (b) Collaboration Compounds properly included by Licensee as Licensed Compounds; provided however, Licensee may substitute a Lead Compound for an existing Licensed Compound as set forth in this Agreement; provided further there shall not be more than two (2) Licensed Compounds at any time during the Term unless Licensee shall have exercised its option to expand the number of Licensed Compounds pursuant to this agreement.

Product(s) shall mean any pharmaceutical preparation containing a Licensed Compound for any and all uses in humans, including any Combination Product.

Field of Use

Field shall mean the treatment and/or prevention of acute or chronic HCV infection in humans by administering a compound whose mechanism of clinical activity results solely from  binding to and inhibiting the serine protease active site of HCV NS3/4A.

Hepatitis C virus (HCV) is a viral infection that causes liver inflammation, sometimes leading to serious liver damage.

License Grant

Licensor hereby grants to the Belgium Licensee an exclusive royalty-bearing right and license, with the right to grant sublicenses, under the Licensor Intellectual Property and Licensors interest in the Collaboration Intellectual Property, to research, develop, make, have made, import, export, use, sell, offer for sale, have sold, distribute, promote, commercialize and otherwise exploit Collaboration Products in the Field in the Territoty; provided, however, that Licensor retains the right under the Licensor Intellectual Property and the Collaboration Intellectual Property to perform Licensors obligations under this Agreement, including conducting the activities set forth in the Joint Plan and Budget.

License Property

Collaboration Product means a Compound, or a pharmaceutical product containing a Compound which product is in any form or formulation or combination, delivery or production system ( e.g., cell lines that produce the protein or peptide therapeutic), or package configuration. For clarity and purposes of this Agreement, antibodies, antibody fragments, chemical compounds, antisense therapeutics, RNA and DNA therapeutics are not Collaboration Products, and 'Collaboration Product' shall not include Licensor Compositions, where 'Licensor Composition' means any active pharmaceutical ingredient ( other than a Compound) whose composition of matter, or method of manufacture or use, is claimed in or embodies any Patent Rights or Know-How solely or jointly with a Third Party owned or controlled by Licensor or any of its Affiliates which was discovered by Licensor or any of its Affiliates outside of the Research Collaboration.

Compound means any native, mutated, or chimeric protein or peptide therapeutic that directly modulates a Target (a 'Target Modulator') and was identified, and such modulation confirmed, by Licensor or Licensee in the performance of the Research Collaboration. For clarity and purposes of this Agreement, antibodies, antibody fragments, chemical compounds, antisense therapeutics, RNA and DNA therapeutics are not Compounds or Target Modulators.

Collaboration Intellectual Property means Collaboration Know-How and Collaboration Patent Rights.

Field of Use

Licensee will utilize Licensor’s proprietary AMP-Rx protein design technology to create a novel therapeutic of Licensee’ selection optimized for improved pharmaceutical characteristics and therapeutic benefits for the treatment of diabetic eye diseases.