Royalty Report: Drugs, Cancer, Disease – Collection: 367579

$150.00

Curated Royalty Rate Report
Category: Technology Licenses, Created On: 2022-04-28, Record Count: 13

Description

This collection of transactions and supporting information was developed using our AI algorithm to curate similar royalty reports into a cohesive collection to support your licensing, transfer pricing or other transaction scenarios where documented royalty rates and/or deal terms are important.
Category: Technology Licenses
Created On: 2022-04-28
Record Count: 13

Primary Industries

  • Drugs
  • Cancer
  • Disease
  • Therapeutic
  • Diagnostic

IPSCIO Report Record List

Below you will find the records curated into this collection.  This summary includes the complete licensed property description so that you can review and determine if this collection covers the topics, technology or transaction type that is relevant for your needs.  The full report will include all relevant deal data such as the royalty base, agreement date, term description, royalty rates and other deal terms.  For reference, here is a sample of a full IPSCIO curated royalty rate report: Sample Report

IPSCIO Record ID: 367579

License Grant
Licensor hereby grants to Licensee, during the Term, an exclusive (subject to Licensor’s retention of certain rights as set forth) royalty-bearing, worldwide license or sublicense (with respect to Licensor Technology and Licensor Patent Rights licensed by third parties to Licensor), with the right to grant sublicenses solely as provided in this Agreement, under Licensor Technology, Licensor Patent Rights and Licensor’s interest in Joint Patent Rights and Joint Technology to make, have made, use, sell, offer for sale and import Products in the Territory.
License Property
STA-4783 means the compound Controlled by Licensor and described more fully in the Agreement.

Indication means any human disease or condition which can be treated, prevented, cured or the progression of which can be delayed.  For purposes of the payment of milestones, with respect to Licensor’s Development Opt-Out Right and with respect to the definition of New Indication, the broadening of use for a Product for a particular Indication, for example, the extension of the use of a Product from treating Stage IV metastatic melanoma to use as an adjuvant treatment for melanoma and/or the approval of a Product as a first line therapy after being approved as a second line therapy for treatment of the same disease or condition shall not be deemed to be separate Indications.

Collaboration Compound means, collectively (a) STA-4783; (b) any  prodrug of STA-4783; (c) any  pharmaceutically active human metabolite of STA-4783; and (d) any other bis thiohydrazide amide isomer, ester, salt, hydrate, solvate and/or polymorph of STA-4783 and/or any of their prodrugs and/or metabolites.  For purposes of this definition, the term Collaboration Compound shall include all Class i Covered Compounds and Class 2 Covered
Compounds not otherwise described in Agreement only to the extent the Parties agree to conduct Development of such Class 1 Covered Compounds or Class 2 Covered Compounds under this Agreement.  As used herein, an isomer of a compound is a positional or conformational variant having the same molecular formula as the compound.

Product means any pharmaceutical or medicinal item, substance, formulation or dosage for sale by prescription, over-the-counter, or any other method, which is comprised of or contains a Collaboration Compound (whether or not such Collaboration Compound is the sole active ingredient).  For purposes of clarity, Product includes Co-Commercialized Products and Royalty-Bearing Products.

Patent Rights
6,800,660 – Taxol enhancer compounds
7,037,940 – Taxol enhancer compounds
6,924,312 – Taxol enhancer compounds

Field of Use
Field of use is for treatment of cancer such as melanoma.

IPSCIO Record ID: 359061

License Grant
Included with this license and collaboration agreement is a license grant upon voluntary termination.

With respect to the applicable Reversion Compounds being terminated, Licensor grants, effective upon such termination, an exclusive even us to Licensor. sub-licensable, worldwide license under the Licensor Reversion Technology to research, develop, import, use, make. have made, offer for sale and sell Reversion Compounds and Reversion Products including as part of a Licensee Combination Therapy in the Field in the Territory.

License Property
Licensors Reversion Technology means Licensor Technology that both was actually used or generated by Licensor or its Affiliates or Sublicensees with respect to the applicable Reversion Compound or Reversion Product, and is necessary to continue development, manufacture or commercialization without unreasonable delay of the applicable Reversion Compound or Reversion Product.

Reversion Compound means NLG919, any Next Generation Compound or any Subsequent Compound.

NLG919 means Licensee’s proprietary small molecule IDO inhibitor known as of the Execution Date as NLG919, or any enantiomer, polymorph, salt form, base, acid, racemate, isomer, diastereomer, tautomer, solvate, hydrate, ester or Known Prodrug thereof.

Next Generation Compound means any Compound other than NLG919 that is invented, by or on behalf of Licensee or its Affiliate, whether solely or jointly, as of the Effective Date or thereafter during the Restriction Period, whether or not pursuant to the Research Plan, that is invented or otherwise the subject of research or preclinical development conducted, by or on behalf of Licensor or its Affiliate or Sublicensee, but excluding the pRED Organization, whether solely or jointly, during the Next Gen Research Term, whether or not pursuant to the Research Plan, the composition of matter, manufacture or use of which is Covered by a Valid Claim of a Licensee Patent or Collaboration Patent; or that is an enantiomer, polymorph, salt form, base, acid, racemate, isomer, diastereomer, tautomer, solvate, hydrate, ester or Known Prodrug of a Compound described above.

Field of Use
Field means any use.

Indication means any separately defined. well-categorized class of human disease, syndrome or medical condition for which a separate MAA may be filed with a Regulatory Authority. Each different tumor type or a different hematological malignancy as classified by cell lineage (e.g., acute lymphoblastic leukemia is a different Indication from chronic myclogenous leukemia) shall be a separate Indication; however each different line of therapy for a particular tumor type or hematological malignancy will not he considered a separate Indication.

IPSCIO Record ID: 372427

License Grant
Swiss Licensor hereby grants to Bermuda Licensee an exclusive, sublicensable (Sublicensing), royalty-bearing right and license under the Licensor Technology and Licensor’s interest in the Joint Technology to Exploit the Licensed Compounds and Licensed Products in the Field in the Licensee Territory.

Licensor hereby grants to Licensee a non-exclusive, sublicensable (Sublicensing) right and license under the Licensor Technology and Licensor’s interest in the Joint Technology to (a) Develop the TAK-385 Licensed Compound and TAK-385 Licensed Products in the Men’s Health Field in the Licensor Territory solely for the purpose of Exploiting such Licensed Products in the Field in the Licensee Territory, or as required in order for Licensee to comply with its diligence obligations set forth in Agreement (Development Diligence Obligations) and (b) Manufacture the TAK-385 Licensed Compound and TAK-385 Licensed Products in the Licensor Territory.

Licensor hereby grants to Licensee (or its Affiliates or its Sublicensees) access to, and a right of reference with respect to, any Licensor Regulatory Materials and corresponding documentation to the extent Controlled by Licensor at any time during the Term, solely for the purposes of (a) Exploiting the Licensed Compounds and Licensed Products in the Field in the Licensee Territory, (b) Developing the TAK-385 Licensed Compound and TAK-385 Licensed Products in the Men’s Health Field in the Licensor Territory, and (c) Manufacturing the TAK-385 Licensed Compound and TAK-385 Licensed Products in the Licensor Territory.

License Property
Licensed Product means any TAK-385 Licensed Product or TAK-448 Licensed Product.

TAK-385 Licensed Product means any pharmaceutical product, including all forms, presentations, strengths, doses, and formulations (including any method of delivery) containing a TAK-385 Licensed Compound.

TAK-448 Licensed Product means any pharmaceutical product, including all forms, presentations, strengths, doses, and formulations (including any method of delivery) containing a TAK-448 Licensed Compound.

Licensed Compound means a TAK-385 Licensed Compound or a TAK-448 Licensed Compound.

TAK-385 Licensed Compound means (a) the chemical compound coded by Licensor as TAK-385 and the structure of which is set forth in Agreement (TAK-385 Licensed Compound); (b) any compound other than TAK-385 that is Covered by any Licensor Patent Right set forth in Agreement (Licensor Patent Rights) that also Covers TAK-385; and (c) any radioisomers, racemates, solvates, salt forms, bases, anhydrides, hydrates, polymorphs, ester forms or prodrugs of any compound described in clause (a).

TAK-448 Licensed Compound means (a) the oligopeptide coded by Licensor as TAK-448 and the structure of which is set forth in Agreement (TAK-448 Licensed Compound); (c) any oligopeptide other than TAK-448 that is Covered by any Licensor Patent Right set forth in Agreement (Licensor Patent Rights) that also Covers TAK-448; and (d) any radioisomers, racemates, solvates, salt forms, bases, anhydrides, hydrates, polymorphs, ester forms or prodrugs of any compound described in clause (a).

Licensor Patent Rights means (a) those Patent Rights set forth in Agreement part (a) (TAK-385 Patent Rights), (b) those Patent Rights set forth in Agreement part (b) (TAK-448 Patent Rights), and (c) all Patent Rights (other than Licensee Patent Rights and Joint Patent Rights) Controlled by Licensor during the Term that Cover any Invention made by or on behalf of Licensor after the Effective Date that Covers a Licensed Compound or any Licensed Product or is otherwise necessary to Exploit any Licensed Compound or Licensed Product.

Field of Use
Field means the treatment, prevention, cure, or control of any human disease, disorder, illness, or condition, including the Men’s Health Field and the Women’s Health Field.

Men’s Health Field means the treatment, prevention, cure, or control of symptoms associated with prostate cancer.

Women’s Health Field means the treatment, prevention, cure, or control of symptoms associated with Uterine Fibroids or Endometriosis.

IPSCIO Record ID: 324643

License Grant
For the Clinical Development and Commercialization.
–  Licensor grants a co-exclusive license under the Licensor Licensed Patents and Licensed Know-How to clinically develop, make, have made, use, sell, offer for sale and import Co-Developed Products in the U.S.
–   Licensor grants an exclusive license under the Licensor Licensed Patents and Licensed Know-How to clinically develop, make, have made, use, sell, offer for sale and import (A) Royalty-Bearing Products in the U.S.; and (B) Products in the Royalty Territory.

Licensor grant a nonexclusive license to use Licensor Marks solely in connection with the Commercialization of the Products in the Territory.

License Property
Product means any therapeutic or prophylactic product, for use in animals or humans, that contains or comprises a Collaboration Compound.

Royalty-Bearing Product means (a) any Product containing or comprizing XL281 (but not XL184); or (b) any XL184 Product for which either (i) an opt-out has occurred or;  (ii) Licensee has converted Licensors right to profit-share.

XL184 means (a) the small molecule compound with Licensor identifier -02977184; (b) the small molecule compounds listed on the Letter Agreement; ( c) any Program Backups to -02977184; and (d) any isomer, racemate, salt, solvate, hydrate, metabolite, conjugate, ester, or prodrug of the compound described.

XL281 means (a) the small molecule compound with Licensor identifier -03832819; (b) the small molecule compounds listed on the Letter Agreement; (c) any Program Backups to -03832819; and (d) any isomer, racemate, salt, solvate, hydrate, metabolite, conjugate, ester, or prodrug of the compound described.

XL880 means (a) the small molecule compound with Licensor identifier -03052880; (b) the small molecule compounds specifically related to -03052880 and licensed by Licensor to Licensee, together with -03052880; and (c) any isomer, racemate, salt, solvate, hydrate, metabolite, conjugate, ester, or prodrug of the compound described.

Field of Use
XL184 inhibits MET, RET and VEGFR2, key drivers of tumor growth and vascularization.

XL281 specifically targets RAF, which is a cytoplasmic serine/threonine kinase that lies immediately downstream of RAS, and is a key component of the RAS/RAF/MEK/ERK pathway that is frequently activated in human tumors. Activating mutations in B-RAF occur in approximately 60% of melanoma patients, indicating a potentially pivotal role for deregulation of this kinase in the progression of melanoma. XL281 is a potent and highly selective inhibitor of RAF kinases, is orally bioavailable and exhibits substantial efficacy in tumor xenograft models.

XL880 is a potent inhibitor of MET and VEGFR2, which play synergistic roles in promoting tumor growth and angiogenesis. Activation or overexpression of MET has been documented as a negative prognostic indicator in patients with various carcinomas and in patients with multiple myeloma, glioma and other solid tumors.

IPSCIO Record ID: 233451

License Grant
Licensor grants a worldwide, exclusive license, with the right to sublicense, under the Licensors Rights, to Develop, make, have made, use, sell, offer for sale, have sold and import the Compound and Products in the Field, and otherwise to perform its obligations expressly set forth in this Agreement and the Co-Promotion Agreement.
License Property
The Compound means either (a) the Initial Compound or (b) any compound that is claimed in U.S. Patent No. 6,288,122 Bl and any hydrates, anhydrides, solvates, salts, esters or polymorphs thereof.

The initial compound means the compound ICA-17043 having the molecular structure set forth and any hydrates, anhydrides, solvates, salts, esters, isomers, prodrugs, metabolites or polymorphs thereof.

The Product means a pharmaceutical product that contains, incorporates or is comprised of the Compound, whether in development or approved by any Regulatory Authority, including all formulations, line extensions and modes of administration thereof.

The Licensor Patents means all Patents, other than CMCC Patents, Controlled by Licensor as of the Effective Date or during the Term, that, absent rights thereunder, would be infringed by the Development, Manufacture, formulation, use, distribution, importation, sale, or offer for sale of Compound or Product, including without limitation any such Patents claiming the composition of matter or the use of Compound or Product or any Improvements thereto.

Licensors know-how means all Information, except for CMCC Know-How, that Licensor Controls as of the Effective Date or during the Term.

Field of Use
The field means prevention and treatment of all human and animal diseases and disorders.  The licensed technology is for use of these compounds include treating sickle cell disease, preventing erythrocyte dehydration and inhibiting potassium flux.

IPSCIO Record ID: 381105

License Grant
Bermuda Licensor hereby grants to Swiss Licensee and its Affiliates and its Sublicensees, access to, and a right of reference with respect to, any Licensor Regulatory Materials and corresponding documentation to the extent Controlled by Licensor at any time during the Term, solely for the purposes of (a) Exploiting the TAK-385 Licensed Compound and TAK-385 Licensed Products in the Field in the Licensee Territory, (b) Manufacturing the Licensed Compounds and Licensed Products, (c) completing the On-Going Clinical Trials and (d) performing Licensee’s obligations under this Agreement with respect to the Licensed Compounds and Licensed Products in the Field in the Licensor Territory.
License Property
Licensed Product means any TAK-385 Licensed Product or TAK-448 Licensed Product.

TAK-385 Licensed Product means any pharmaceutical product, including all forms, presentations, strengths, doses, and formulations (including any method of delivery) containing a TAK-385 Licensed Compound.

TAK-448 Licensed Product means any pharmaceutical product, including all forms, presentations, strengths, doses, and formulations (including any method of delivery) containing a TAK-448 Licensed Compound.

Licensed Compound means a TAK-385 Licensed Compound or a TAK-448 Licensed Compound.

TAK-385 Licensed Compound means (a) the chemical compound coded by Licensee as TAK-385 and the structure of which is set forth in Agreement (TAK-385 Licensed Compound); (b) any compound other than TAK-385 that is Covered by any Licensee Patent Right set forth in Agreement (Licensee Patent Rights) that also Covers TAK-385; and (c) any radioisomers, racemates, solvates, salt forms, bases, anhydrides, hydrates, polymorphs, ester forms or prodrugs of any compound described in clause (a).

TAK-448 Licensed Compound means (a) the oligopeptide coded by Licensee as TAK-448 and the structure of which is set forth in Agreement (TAK-448 Licensed Compound); (c) any oligopeptide other than TAK-448 that is Covered by any Licensee Patent Right set forth in Agreement (Licensee Patent Rights) that also Covers TAK-448; and (d) any radioisomers, racemates, solvates, salt forms, bases, anhydrides, hydrates, polymorphs, ester forms or prodrugs of any compound described in clause (a).

Licensee Patent Rights means (a) those Patent Rights set forth in Agreement part (a) (TAK-385 Patent Rights), (b) those Patent Rights set forth in Agreement part (b) (TAK-448 Patent Rights), and (c) all Patent Rights (other than Licensor Patent Rights and Joint Patent Rights) Controlled by Licensee during the Term that Cover any Invention made by or on behalf of Licensee after the Effective Date that Covers a Licensed Compound or any Licensed Product or is otherwise necessary to Exploit any Licensed Compound or Licensed Product.

Field of Use
Field means the treatment, prevention, cure, or control of any human disease, disorder, illness, or condition, including the Men’s Health Field and the Women’s Health Field.

Men’s Health Field means the treatment, prevention, cure, or control of symptoms associated with prostate cancer.

Women’s Health Field means the treatment, prevention, cure, or control of symptoms associated with Uterine Fibroids or Endometriosis.

Uterine fibroids, also known as uterine leiomyomas or fibroids, are benign smooth muscle tumors of the uterus.
Endometriosis is a disease of the female reproductive system in which cells similar to those in the endometrium, the layer of tissue that normally covers the inside of the uterus, grow outside the uterus.

relugolix (TAK-385) is a phase 3 drug candidate that has been evaluated in over 1,300 patients to date. Relugolix has successfully demonstrated significant clinical benefit and was generally well-tolerated across multiple, large, randomized phase 2 clinical trials in three different indications. Relugolix is being developed as an oral, once-daily, potential best-in-class gonadotropin-releasing hormone (GnRH) receptor antagonist for uterine fibroids, endometriosis and prostate cancer.

IPSCIO Record ID: 369293

License Grant
Licensor hereby grants to Licensee an exclusive (even as against Licensor and its Affiliates), nontransferable (except with respect to the assignment provision in Agreement) limited license during the Term under the Licensed Patents, solely to make, have made (pursuant to Agreement), use, sell, offer for sale and import the Licensed Products in the Territory in and for the Field. (No license, exclusive or nonexclusive, is granted hereunder under the Licensed Patents, except to so make, have made, use, sell, offer for sale and import the Licensed Products in the Territory in and for the Field.)
License Property
Patents
5,874,418 – Sulfoalkyl ether cyclodextrin based solid pharmaceutical formulations and their use
6,046,177 – Sulfoalkyl ether cyclodextrin based controlled release solid pharmaceutical formulations
6,133,248 – Polar drug of prodrug compositions with extended shelf-life storage and a method of making thereof

Licensed Product means (a) a Compound combined with or formulated using Captisol for ultimate use in humans in a dosage form/formulation, or (b) a pharmaceutical composition that includes a Compound and that is developed with the assistance of or incorporates any then-confidential component of the Captisol Data Package.

Compound means the proprietary Licensee isoflavone-based drug compound known as ME-143 (also known as NV-143) or the proprietary Licensee mitochondrial inhibitor drug compound known as ME-344, or any derivative, homolog, or analog of ME-143 or ME-344 or any isomer, salt, hydrate, solvate, amide, ester, metabolite, or prodrug of any of the foregoing.

Captisol Related Compound means Captisol or any derivative, homolog analog of Captisol or any isomer, salt, hydrate, solvate, amide, ester, metabolite or product of any of the foregoing, including without limitation sulfobutylether g(gamma) cyclodextrin sodium salt.

Licensed Product Family means one or more Licensed Products which are based on the same Compound(s) (or any isomers, salts, hydrates, solvates, amides, esters, metabolites, or prodrugs of the foregoing), irrespective of whether such Licensed Products contain different dosage forms, proportions or formulations of such Compound(s), utilize different inactive ingredients and/or are marketed for different indications. Notwithstanding the foregoing, a Licensed Product based on a Compound shall be deemed to be in a distinct Licensed Product Family from a Licensed Product based on the combination of the same relevant Compound with any other active pharmaceutical ingredient. As such, if Licensee develops one Licensed Product with ME-344 as the sole active ingredient with Captisol and also develops another Licensed Product with ME-344 in combination with another active ingredient with Captisol, then two distinct sets of milestone payments shall be potentially due under this Agreement, one for each of such two distinct Licensed Products.

Field of Use
Captisol® is a patent protected, uniquely modified cyclodextrin, whose chemical structure was rationally designed to enable the creation of new products by significantly improving solubility, stability, bioavailability and dosing of active pharmaceutical ingredients (APIs).

Captisol is  for use with the Licensee’s isoflavone-based drug compounds.

ME-344 is our isoflavone-derived mitochondrial inhibitor drug candidate. In preclinical studies, ME-344 has been shown to cause cell death in multiple human tumor cell lines, including ovarian cancer stem cells, by interfering with mitochondrial energy generation.

Field means the entire field of prevention, diagnosis and treatment of all human and animal diseases and disorders with the exceptions of (i) ocular treatment of any disease or condition with a formulation including a hormone; (ii) topical ocular treatment of inflammatory conditions; (iii) treatment and prophylaxis of fungal infections in humans; and (iv) any ocular treatment for retinal degeneration.

IPSCIO Record ID: 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.

IPSCIO Record ID: 356954

License Grant
For the Development and Commercialization License, Licensor grants an exclusive license sublicenseable, under the Licensor Technology to research, make, have made and use Compounds in the Territory pursuant to the Next Gen Research Plan; to make or have made Licensed Compounds in the Territory for use in the manufacture of Licensed Products to develop, make, have made, use, sell, offer for sale, and import Licensed Products in the Field in the Territory; and, an exclusive license, sublicenseable, under the Licensor know-how to research Subsequent Compounds in the Territory, to make or have made Subsequent Compounds in the Territory for research use or for use in the manufacture of Subsequent Products and to develop, make, have made, use, sell, offer for sale, and import, Subsequent Products in the Field in the Territory; and,
an exclusive license, sublicenseable, under the Licensor know-how, solely after the end of the Restriction Period, to research, develop, make, have made, use, sell, offer for sale, and import Compounds in the Field in the Territory.

For the Research License, Licensor grants a perpetual, irrevocable, non-exclusive, non-sublicensable except to Third Party contractors and service providers performing for the benefit of Licensee,  license under the Licensor Technology and Licensee Technology to make, import, and use but not to sell or offer for sale Compounds for internal research purposes only.

Licensor grants an option to obtain an exclusive, sublicense from Licensor to certain Patent Rights licensed to Licensor under the Georgia Regents Research Institute License Agreement or Lankcnau Institute for Medical Research License Agreements, to research, develop, make, have made, use, sell, offer for sale and import Compounds and Licensed Products in the Field in certain countries in the Territory.

License Property
Licensor controls certain patents and know-how relating to its proprietary program regarding inhibitors of the IDO Target and TDO Target, including patents and know-hem covering the lead compound NLG919 and other compounds that are inhibitors of one or both targets.  IDO Target means indoleamine 2,3-dioxygenase 1.  TDO Target means tryptophan 2,3-dioxygenase.

Licensed Compound means NLG919 or any Next Generation Compound.

NLG919 means Licensor’s proprietary small molecule IDO inhibitor known as of the Execution Date as NLG919, as further described in IND 119045 or any enantiomer, polymorph, salt form, base, acid, racemate, isomer, diastereomer, tautomer, solvate, hydrate, ester or Known Prodrug thereof.

Compound means a compound with a molecular weight of two thousand (2,000) Daltons or less], that hinds to and inhibits the activity of one or both of the 100 Target and TDO Target. with an IC50 of 1 µMor less in the applicable Enzymatic Assay, and that is being researched, developed or commercialized to exert its influence through the inhibition of one or both of the IDO Target or TDO Target, including NLG919, but excluding Indoximod.

Enzymatic Assay means, with respect to the IDO Target, the assay described in IND 119045 Document PD0l-MRMP01 1-SP04-E248, and, with respect to the TDO Target. Enzymatic Assay shall also include an alternate means of detecting the products of the enzyme reactions or minor changes in the above enzyme assay protocols, as agreed upon by the JRC. Any IC50s of control compounds measured with an alternate assay format should fall within 3-fold of the assay method.

Indoximod means Licensor’s proprietary small molecule IDO pathway inhibitor known as of the Execution Date as indoximod, or 1-methyl-D-tryptophan, or any, enantiomer, polymorph, salt form, base, acid, racemate, isomer, diastereomer, tautomer, solvate, hydrate, ester or Known Prodrug thereof.

Field of Use
The agreement also calls for the Parties to engage in a research collaboration for the discovery of next generation IDO/TDO compounds, which represent potential breakthrough approaches to cancer therapy.

IDO pathway inhibitors are another class of immune check point inhibitors akin to the recently developed antibodies targeting CTLA-4, PD-1, and PD-L1 that represent potential breakthrough approaches to cancer therapy. The IDO pathway regulates immune response by suppressing T-cell activation which enables local tumor immune escape. Recent studies have demonstrated that the IDO pathway is active in many cancers, both within tumor cells as a direct defense against T-cell attack, and also within antigen presenting cells in tumor draining lymph nodes whereby this pathway promotes peripheral tolerance to tumor associated antigens (TAAs). When hijacked by developing cancers in this manner, the IDO pathway may facilitate the survival, growth, invasion and metastasis of malignant cells whose expression of TAAs might otherwise be recognized and attacked by the immune system. NewLink has a number of active programs directed at synthesizing inhibitors to the IDO pathway and additionally has discovered novel tryptophan-2,3-dioxygenase (TDO) specific inhibitors that are potential anti-cancer compounds which could function individually or in combination with IDO inhibition.

Indication means any separately defined. well-categorized class of human disease, syndrome or medical condition for which a separate MAA may be filed with a Regulatory Authority. Each different tumor type or a different hematological malignancy as classified by cell lineage (e.g., acute lymphoblastic leukemia is a different Indication from chronic myclogenous leukemia) shall be a separate Indication; however each different line of therapy for a particular tumor type or hematological malignancy will not he considered a separate Indication.

IPSCIO Record ID: 299247

License Grant
Licensor grants
—  an exclusive license, with right to sublicense through one or more tiers, under the Licensed Patent Rights to make, have made, use, have used, sell, have sold, offer for sale, have offered for sale, import and have imported Products in the Field.  
—  an exclusive license, with right to sublicense through one or more tiers, under the Know-How, to make, have made, use, have used, sell, have sold, offer  for sale, have offered for sale, import and have imported Products in the Field and a nonexclusive license to any other know-how existing on the Closing Date and provided to Licensee which is useful to develop or commercialize the Products in the Field.
License Property
Licensor has research regarding small-molecule immune response modifier compounds and other small molecule compounds, some of which act by stimulating basic immune cell receptors known as toll-like receptors  (TLRs) 7 and/or 8.

The Assigned Patent Rights and Licensed Patent Rights include any prodrug or any hydrate, solvate, conjugate, salt, ester, stereoisomer or polymorph of such compound or prodrug.

Field of Use
The Field means the diagnosis, treatment, mitigation, or prevention of any disease or condition in humans or animals, other than uses that are within the Excluded Fields. The Excluded Fields are
—  the treatment, topically or systemically, of diseases of the cervix or vaginal tract caused by human papilloma virus (HPV) infection, including cervical high risk·HPV infection and cervical dysplasia, and the treatment of cervical malignancy by topical application to the cervix, but not including systemic treatments of cervical malignancy;
—  any use of imiquimod, 848 (resiquimod}, 850 (sotirimod), and the alkyl ureas S-32913 and S-33005, including any acid, ester, salt, amide, prodrug, polymorph, enantiomer or isomer thereof, and any pharmaceutical product containing such compounds, in the Topical Field, which means the treatment, mitigation, or prevention of a disease or condition by topical application (e.g., dermatological, pulmonary or vaginal) of the drug to the skin or mucosa (e.g., bronchialand vaginal tissue) of a patient by, for example, but not limited to, gels, creams, ointments, foams, lotions, salves, roll-ons, powders, sprays, or inhalants, like aerosols such as for asthma and allergic rhinitis;
—  marketing the 3MIRM Compounds 852 (N-[4-(4-amino-2-ethyl-1Himidazo[4;5 c]quinoliri-1-yl)butyl]methanesulfonamide) and/or 854 (N-{2-[4-amino-2 ( ethoxymethyl)-1 H-imidazo[ 4, 5-c]quinolin-1-yl]-1 , 1-d imethylethyl}methanesulfonamide)  (including any acid, ester, salt, amide, pro-drug, polymorph, enantiomer or isomer thereof, and.any pharmaceutical product containing such compounds) for the indications of genital warts, common warts, basal cell carcinoma, actinic keratosis, tattoo removal, or photoaging; and
— any use of the 3M Compounds as a Vaccine Adjuvant.

IPSCIO Record ID: 203285

License Grant
Licensor grants an exclusive, worldwide, non-transferable, license, with the right to sublicense, under the Licensor Patent Rights and Know-How to make, use, including in activities directed at the research and Development of Licensed Compounds, have made, sell, have sold, offer to sell, export, import and otherwise exploit or Commercialize Licensed Compounds and Licensed Products in the Field in the Territory.

Licensor grants a non-transferable, non-exclusive license, with the right to sublicense, under the Licensor Other Patent Rights solely to the extent reasonably necessary to make, use (including in activities directed at the research and Development of Licensed Compounds), have made, sell, offer to sell, export and import and otherwise exploit or Commercialize Licensed Compounds and Licensed Products in the Field in the Territory.

License Property
MS564929 Toxicology Studies means the two (2) toxicology reports due n the IND covering the BMS compound designated BMS564929, specifically the 6 onth oral toxicology studies in rats and dogs.

6,670,386 – Bicyclic modulators of androgen receptor function

The licensed compounds and patents relate to controlling various diseases and cancers.

Field of Use
The Field means the diagnosis, prevention, treatment or control of any human or animal disease, disorder or condition, excluding the prevention, treatment or control of any human or animal hyperproliferative disease, disorder or condition. For purposes of clarity, hyperproliferative diseases, disorders and conditions are those diseases, disorders or conditions which are characterized by an abnormal increase in the proliferation or accumulation of cells and include conditions such as cancers and benign hyperplasia, but not diseases, disorders or conditions incident to an abnormal increase in the proliferation or accumulation of cells.

IPSCIO Record ID: 279352

License Grant
The German Licensor grants an exclusive, even as to Licensor, worldwide license under the Licensor Patents and Know-How to make, use, sell, offer to sell and import Products in the Field in the Territory.

Licensor grants an Option to obtain a non-exclusive license to the Eye Technology in the Field.

License Property
Licensor owns certain intellectual property rights relating to I-131 labeled ZK-BA, a new class of proprietary benzamide compounds highly accumulating in metastatic melanoma.

Compounds means the ZK-BA compounds and derivatives thereof, a new class of benzamide compounds highly accumulating in metastatic melanoma, that may be of use in the field of oncology, and in particular for the diagnosis and treatment of metastatic melanoma.

Technology shall mean benzamide compounds highly accumulating in metastatic melanoma controlled by Licensor.

Licensor Know-how consists of all data disclosed with the exception of know-how in relation to the administration of the Compounds and the use of blood-supply modulators to reduce eye uptake in order to minimize potential side effects of the Compounds.

Field of Use
The Field means any use in the diagnosis, cure, mitigation, treatment or prevention of disease in human beings in the field of oncology.

IPSCIO Record ID: 237253

License Grant
Licensor grants an exclusive worldwide license under Licensor Technology solely in the Field, with the right to sublicense, to exercise its rights and carry out its obligations set forth in this Agreement; to develop, use, have used, manufacture, have manufactured, and import, the Compound, Bulk Drug Substance, and Drug Products in the Territory; to offer for sale, sell and import for sale Compound and Bulk Drug Substance, solely for purposes of incorporation into a Drug Product for sale, offer for sale, import and having sold pursuant to the terms of this Agreement; and to market, sell, have sold, import, and offer for sale, Drug Products in the Territory.

Licensor grants an exclusive worldwide license under the Licensor Technology, with no right to sublicense, to the extent useful to permit Licensee to use Biomarkers to monitor the effectiveness of the Compound in the Field, including in human subjects, solely in connection with research and/or development of Drug Products.  Licensor agrees that it shall negotiate in good faith with Licensee to reach agreement on a license to diagnostic products incorporating such Biomarkers for use solely in connection with the administration of the Drug Product in the Field. Licensor reserves all rights to Biomarkers and the use thereof for all purposes outside the Field.

This agreement also includes a non-exclusive grant back to Licensor.

License Property
Licensor has undertaken research and development relating to small molecule inhibitors of IMPDH, including VX-944.

The Compound shall mean VX-944 and  and any of its hydrates, salts, stereoisomers, polymorphs, prodrugs or metabolites.

IMPDH shall mean Inosine 5 -monophosphate dehydrogenase.

Drug Product shall mean any pharmaceutical preparation in finished dosage form containing the Compound for administration to human patients for any and all uses in the Field.

VX-944 is a small molecule, selective, uncompetitive novel inhibitor directed against human IMPDH enzyme. IMPDH inhibitors have been demonstrated to induce growth arrest, and extensively investigated as immunosuppressants. Here we show that VX-944 inhibits growth of human multiple myeloma (MM) cell lines, including those resistant to conventional agents, via induction of apoptosis and S phase arrest in vitro.

Field of Use
Field shall mean the administration or use of the Compound for the treatment or prevention of cancer in humans.
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