Royalty Report: Disease, cardiac, Drugs – Collection: 282874

Licensor hereby grants Licensee and itsAffiliates, during the Collaboration Program Term, an exclusive right to access, test, profile, analyze and use all Biological Samples and Data within the TALON Registry as Licensee deems scientifically appropriate. Following the Collaboration Program Term, Licensees exclusive access rights to such Biological Samples and Data shall continue when and if it Triggers the Product Exclusivity License or the Test Exclusivity License. If Licensee does not Trigger either a Product Exclusivity License or Test Exclusivity License, Licensees exclusive access rights to such Biological Samples and Data convert into non-exclusive access rights.

Licensor hereby grants to Licensee a non-exclusive, sublicensable license in the Territory under Licensor Collaboration Program Patents, and to use Licensor Collaboration Program Inventions and Results:

(i) In the Test Field, subject to the non-exclusivity milestones and royalties described; and

(ii) For all uses outside of the Test Field, subject to the non-exclusivity milestones and royalties described.

The exclusive license grants (b) shall become effective and the non-exclusive license grants (a) shall expire as follows:

(i) The exclusive license grant (b)(i) shall become effective and the non-exclusive license grant (a)(i) shall expire, immediately upon Licensee’s written notice to Licensor of its desire to trigger the Test Exclusivity License, subject to Licensee’s payment of the fee described, provided that Licensee sends such notice to Licensor prior to the expiration of the Option Period;

(ii) The exclusive license grant (b)(ii) shall become effective and the non-exclusive license grant (a)(ii) shall expire, immediately upon Licensee’s written notice to Licensor of its desire to trigger the Product Exclusivity License, subject to Licensee’s payment of the fee described in Section 5.7.1, provided that Licensee sends such notice to Licensor prior to the expiration of the Option Period.

If the making, having made, use, offer for sale, sale or import by Licensee, its Affiliates and sublicensees of Therapeutic Products or Tests would infringe during the term of this Agreement a claim of issued letters patent either in existence as of the Effective Date, or claiming priority to an application in existence as of the Effective Date and Controlled by Licensor and which patents are not otherwise covered by the license grant, Licensor hereby grants to Licensee, to the extent Licensor is legally able to do so, a non-exclusive, royalty-free license in the Territory under such issued letters patent for Licensee, to develop, make, have made, use, sell, offer for sale or import Therapeutic Products, Products and Tests in the Territory. Such non-exclusive license is sublicensable, but only to the extent the sublicensee is acting on behalf of Licensee or a Licensee Affiliate.

TALON Registry means: (a) Licensor’s multi-center registry designed to capture and archive patient outcomes data, as well as all biological material, such as excised plaque using Licensor technology, which such registry is expected to be closed prior to or shortly after the Effective Date, and (b) any and all de-identified patient-related clinical and demographic data corresponding to such biological material, as well as any genetic, and genomic data associated with such collections.

Combination Product means a product containing both a Therapeutic Product as well as one or more active ingredients that are other than a Profiled Compound. All references to Product in this Agreement shall be deemed to include Combination Products.

Product means each of the Dose Ranging Product, Labeled Product and Enhanced Labeled Product, and each Products means all such products, collectively. Product also includes any Combination Product

Therapeutic Product means any pharmaceutical or biological preparation in final form containing a Profiled Compound for: (a) sale by prescription, over-the-counter or any other method; or (b) administration to human patients in a Phase III Clinical Trial.

Profiled Compound means any chemical compound (including but not limited to small molecules, proteins, antibodies and therapeutic nucleic acids): (a) for which Biological Samples and Data is generated concerning such compound’s effectiveness; or (b) the discovery, identification or development of which utilizes or is based upon Collaboration Program Inventions and Results.

Collaboration Program Patent Rights means any and all patents and patent applications (which for the purposes of this Agreement shall be deemed to include certificates of invention, provisional applications, and applications for certificates of invention) claiming any Collaboration Program Invention and Results.

The Parties agreed to collaborate on the analysis of atherosclerotic plaque removed from patient arteries with the goal of identifying new biomarkers of atherosclerotic disease progression.

Atherosclerosis is a disease in which plaque builds up inside your arteries. Arteries are blood vessels that carry oxygen-rich blood to your heart and other parts of your body. Plaque is made up of fat, cholesterol, calcium, and other substances found in the blood. Over time, plaque hardens and narrows your arteries.

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.

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.

Joint Research Committee or “JRC” shall mean the entity organized to manage the scientific implementation of the Collaboration.

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

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

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).

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.

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.

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 Licensor, Licensee 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 Licensee or Licensor during the term of this Agreement; provided, however, that Collaboration Patents shall not include any Licensor Patents or Licensee Patents.

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

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.

For abandoned compounds, Licensor grants a license, for use solely within the field , under any patent rights owned or controlled by Licensor relating to the composition or use or manufacture of any such abandoned Collaboration Compound or Product owned or controlled by Licensor or that was licensed by Licensee to Licensor, and to any regulatory filings, Pre-Clinical Data, and Clinical Data owned or controlled by Licensor relating to any such Collaboration Compound or Product for development or use within the Field.   Such license shall be exclusive as to the commercialization of any Collaboration Compound or Product for use within the field and shall be non-exclusive for any other use or purpose within the field, such as use of collaboration compounds for research and development purposes.

The license is for Formulae for Licensees Mineralocorticoid Antagonist Leads.

The collaboration tagreement focuses on the discovery, design, and development of orally active compounds that selectively modulate the mineralocorticoid receptor.

This receptor plays a critical role in many illnesses, particularly cardiovascular diseases such as congestive heart failure and hypertension.

Licensor grants a non-exclusive, royalty free license to use Licensors corporate Trademarks solely for purposes of Commercializing Products, which license shall terminate upon the expiration or earlier termination of this Agreement for any reason.

Compound means AGI-1067, which is chemically defined as Butanedioic acid, including its pharmacologically acceptable salts, solvates, hydrates, hemihydrates, polymorphs, metabolites; free base forms, pro-drugs, esters, tautomers and if applicable, any isomers, stereoisomers, racemates, enantiomers and all optically active forms thereof.

AGI-1067 is a novel vascular protectant, anti-inflammatory drug and mild antiplatelet agent for treatment of atherosclerosis.
Atherosclerosis is a disease in which the inside of an artery narrows due to the build up of plaque.