Royalty Report: Drugs, Disease, Drug Discovery – Collection: 233441

License Grant

The Parties desire to establish a broad collaboration for the further development and commercialization of Compound, with the objective of utilizing the areas of expertise of both Parties to provide products to patients.

For the ROW Territory, Licensor grants an exclusive license, with the right to grant sublicenses, under the Licensed Patents, the Licensed Know-How and Licensor’s interest in any Joint Collaboration Patents to Develop and use Collaboration Products for Commercialization in the Field in the ROW Territory and to Commercialize Collaboration Products in the Field in the ROW Territory, and to make bulk and finished Collaboration Products, but not the Compound, except as otherwise provided, for Commercialization in the Field in the ROW Territory.

For the US Territory, Licensor grants an exclusive, except as to Licensor, license, without the right to grant sublicenses, under the Licensed Patents, the Licensed Know-How and Licensor’s interest in any Joint Collaboration Patents to Commercialize Collaboration Products in the Field in the US Territory and to Develop and use Collaboration Products for Commercialization in the US Territory.

For the trademark, Licensor shall grant a non-exclusive license, with the right to grant sublicenses, to use such Mark in the US Territory and/or ROW Territory, as applicable, solely in conjunction with the Commercialization of the Collaboration Products.

License Property

The Compound means the compound currently identified by Licensor with the chemical structure 1 (2S, 2 S)-2,6-diamino-N-(l-phenylpropan-2-yl) hexanamide dimethanesulfonate and any isomers, salts, solvates, polymorphs, esters and derivatives of any of the foregoing, in each case where an active moiety of such compound is an amphetamine.

The Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

The Combination Product means any Collaboration Product that contains the Compound and one or more pharmaceutically active ingredients in addition to Compound, and any and all Improvements thereto.

Solid Oral Delivery means a tablet, capsule or gelcapsule administered through the mouth.

Licensed Patent means a Patent that claims the Manufacture, use, Development, Commercialization and/or export of the Compound, a Collaboration Product and/or a Licensor Invention, and is Controlled by Licensor as of the Effective Date or at any time during the Term. For the avoidance of doubt, all Licensor Collaboration Patents shall be considered Licensed Patents.

Field of Use

The Field means all human and veterinary pharmaceutical uses.  Licensor is clinically developing a proprietary amphetamine conjugate for the treatment of attention deficit/hyperactivity disorder in pediatric and adult patients.

License Grant

The parties wish to enter into a collaboration employing Licensees medicinal chemistry, analytical chemistry and primary biology capabilities and Licensors chemistry, in vitro biology, and in vivo biology capabilities, in order to develop and commercialize pharmaceutical compounds subject to and in accordance with the terms and conditions of this Agreement (the “Collaboration”).

License to Commercialize Collaboration Compounds – With respect to all Collaboration Compounds for which Licensee has received Licensors approval to develop and commercialize, Licensor grants to Licensee a worldwide, exclusive license, with the right to sublicense, under the Licensor IP and Licensor’s 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, perpetual, exclusive, royalty-free license, with the right to sublicense, under Licensors interest in the Collaboration IP, to exploit for any and all purposes all compounds (other than Collaboration Compounds) derived, directly or indirectly, from Licensee Compounds.

Research Licenses – The Parties hereby grant each other non-exclusive, worldwide, royalty-free research licenses, without the right to sublicense, under their respective interests in the Licensee IP, Licensor IP and Collaboration IP, in order for each Party to perform its research obligations pursuant to Research Plans during the Collaboration Term.

License Property

Collaboration Compound shall mean a Licensee Compound or a Non-Exclusive Compound or a compound that is derived, directly or indirectly, from a Licensor 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 Licensee or Licensor 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 Licensor Compound, Licensee 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.

Licensee IP shall mean Licensee Patents and Licensee Know-how.  Licensee IP shall not include any intellectual property owned or licensed by Licensee 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).

Field of Use

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

Licensor 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.

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.

License Grant

The Licensor of Switzerland and the Licensee now desire to modify their arrangements under the Original Agreement to provide, among other things, for the relinquishment of the sublicenses and licenses granted by Licensor to Licensee under the Original Agreement in the U .S./Canadian Territory, for the grant by Licensee to Licensor of exclusive license rights with respect to certain Licensee Know-How and Licensee Trademarks and for the assignment by Licensee to Licensor of the Existing Applications and Approvals and the Licensee Domain Names.

The Swiss Licensor grants an Exclusive sublicense in the Field under the Patents licensed to Licensor or its Affiliates and an Exclusive license in the Field under the Patents, except for the Biomarker Patent, owned by Licensor or its Affiliates,  an Exclusive sublicense and license, as applicable, in the Field under the Know-How and a non-exclusive license in the Field under the Patent owned by Licensor covering the biomarker, in each case, to research, develop, have developed, make, have made, use, import, sell, offer for sale and have sold the Compound and Product in the ROW Territory,

Licensor grants a non-exclusive, ROW Territory sublicense to make or use any analytical reference standards, intermediate or metabolite of the Compound or Product, not listed, which may be claimed in Patents in the ROW Territory limited solely to making or using the Compound or Product.

License Property

Compound shall mean the chemical compound known as Iloperidone, whose specific chemical name is I-[ 4-[3 -[ 4-( 6-fluoro-1,2-benzisoxazol-3-y 1 )-1-piperidiny l] propoxy]-3-methoxyphenyl]ethanone, including any salts, hydrates, solvates, and/or stereoisomers thereof, and only the metabolites listed, including any salts, hydrates, solvates and/or stereoisomers of such metabolites.

Product shall mean any bulk or finished pharmaceutical composition containing the Compound as a pharmaceutically active ingredient for use in the Field.

Depot Formulation shall mean any extended-release, injectable formulation of the Compound.

The parties acknowledge and agree that Products sold within the United States will be sold only under the  trademark FANAPTâ„¢.

Field of Use

Field shall mean application to all conditions, disorders and diseases in humans.  The licensed patents field of use is as antipsychotic drugs.

License Grant

For the exclusive license, Licensor grants to the Licensee of Japan an exclusive right and license in the Territory under Licensors interest in the Collaboration Patent and the Collaboration Know-How, with a right to sublicense, to develop, make, have made, use, offer for sale and/or sell, import and export any Active Compound, Active Claimed Compound and/or Derivative Compound, and, also with a right to sublicense, to develop, make, have made, use, import and export, offer for sale and/or sell any Collaboration Product or Product.

For the Non-Exclusive Licenses for
—  The Collaboration Technology, Licensor grants to a non-exclusive, sublicensable license in the Territory under Licensors interest in the Collaboration Patent and the Collaboration Know-How, to develop, make, have made, use, offer to sell, sell, import and export any Inactive Compound or Claimed Compound, other than Active Claimed Compounds, and upon Licensees discovery that a particular Inactive Compound or such Claimed Compound is active against a particular target, the right to negotiate to obtain the exclusive rights to such Inactive Compound or Claimed Compound, in each case in the Territory.
—  The Pre-existing Licensor Patents, In the event that the development, making, having made, use, offer for sale, sale, import and export by Licensee of any Active Compound, Inactive Compound, Active Claimed Compound, Claimed Compound or Derivative Compound, any Collaboration Product, Product or any product containing an Inactive Compound, a Claimed Compound or Derivative Compound would infringe during the term of the Agreement a claim of Pre-existing Licensor Patent, Licensor grants to the extent Licensor is legally able to do so, a non-exclusive, sublicensable, license in the Territory under such Pre-existing Licensor Patent for those purposes, and,
— The Inactive Compounds and Claimed Compounds, with respect to an Inactive Compound or a Claimed Compound, at least 90 days prior to Licensor entering into material and substantial negotiations to grant to a Third Party any rights to such Inactive Compound or Claimed Compound, Licensor agrees to notify Licensee in writing, together with a description of the chemical entity that would be the subject of such negotiations. Within 30 days after receipt from Licensor of such notice, Licensee shall notify Licensor whether or not it desires to discuss terms and conditions under which Licensor would grant exclusive rights to such Inactive or Claimed Compound to Licensee.

License Property

Licensor has expertise and proprietary technology for the discovery, generation, optimization and preclinical testing of small molecule clinical candidates from drug discovery programs.

Field of Use

The Field means the discovery, development and commercialization of small molecules for the diagnosis or therapeutic or prophylactic treatment of diseases and conditions, wherein the primary mechanism of action of such small molecules is to modulate the activity of a Collaboration Target.

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.

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.