Royalty Report: Drugs, Disease, Research – Collection: 291164

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 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

For Licensed Products,  Licensor grants the Swiss Licensee an exclusive, even as to Licensor, license under the Licensor Patent Rights and Know-How, with the right to grant sublicenses, to make, use, sell, offer for sale, import and export Licensed Products for all uses in the Territory.

For HCV Activity Compounds, Licensor grants an exclusive, even as to Licensor, license under the Licensor Patent Rights to make, use, offer for sale, import and export any HCV Activity Compounds solely within the Field in the Territory.

Licensor grants a non-exclusive license under any such patents to develop, make, have made, import, export, use, offer for sale and sell Licensed Products for all uses in the Territory.

For research, Licensor grants a non-exclusive license under its patents, trademarks and other intellectual property only to the extent necessary to carry out Licensees obligations and responsibilities under the Research Program and to develop and commercialize a Licensed Product.

Licensee, its Affiliates and sublicensees shall be free to use and to register in any trademark office worldwide any Trademark for use with Licensed Products they desire in their sole discretion.

License Property

The Licensed Product means anything containing or derived from a Candidate Compound.  The Candidate Compound means chemical entities designed or identified by Licensor as of the Effective Date or pursuant to the Research Program that are inhibitors of at least one (1) protease of the Hepatitis C virus.

HCV Activity Compounds means Candidate Compounds, other than Licensed Products or Back-Up Compounds, or Non-Collaboration Compounds meeting the HCV Activity Criteria set forth.

The patents are those filed to protect Licensor Inventions or interest in Joint Inventions, or otherwise filed to protect either a transition state-based inhibitor of the NS3 protease of the Hepatitis C virus existing within Licensor Know-How as of the Effective Date or an inhibitor of the Hepatitis C viral proteases within Licensor KnowHow arising from the Research Program.

Field of Use

This agreement is for the treatment or prevention of Hepatitis C infections in humans and/or animals.

License Grant

Licensor hereby grants Licensee an exclusive (even as to Licensor), royalty-bearing license in the territory, without the right to grant sublicensees, under all Patent Rights and Know-How Controlled by Licensor (other than Patent Rights and Know-How jointly owned by Licensor and one or more of its Third Party collaborators) to make, have made, use, offer to sell, sell, import, export and otherwise Develop and Commercialize all JAK-3 Kinase Inhibitors having as their primary mechanism of action JAK-3 Kinase Inhibitory Activity (and products containing any such JAK-3 Kinase Inhibitors) in the Licensee Field during the JAK-3 exclusivity period.

Licenosr hereby grants Licensee an exclusive (even as to Licensee), royalty-bearing license in the  Territory, without the right to grant sublicenses, under all of Licensors rights under all JAK-3 Joint Patent Rights to make, have made, use, offer to sell, sell, import, export and otherwise Develop and Commercialize all JAK-3 Kinase Inhibitors having as their primary mechanism of action JAK-3 Kinase Inhibitory Activity (and products containing any such JAK-3 Kinase Inhibitors) in the Licensee Field during the term.

Licensor hereby grants Licensee an exclusive (even as to Licensor), royalty-beariing license in the Territory, with the right to grant sublicenses, (Sublicensing), under the Licensor IP and Licensors rights, title and interests in the Joint IP to make, have made, use, offer to sell, sell, import, export and otherwise Develop and Commercialize Licensee Available Compounds (and any Licensee Products containing any such Licensee Available Compounds) in the Licensee Field.

License Property

JAK-3 Kinase Inhibitor means a molecule that has JAK-3 Kinase Inhibitory Activity at an in vitro fifty percent (50%) inhibitory concentration (IC50) of less than or equal to 1 micromolar.

JAK-3 Kinase Inhibitory Activity means, when used to describe a compound, that the compound binds to the protein tyrosine kinase enzyme known as Janus Activating Kinase 3 (JAK-3).

JAK-3 Joint Patent Right means Joint Patent Rights that claim inventions that are reasonably necessary to make, have made, use, offer to sell, sell, import, export and otherwise Develop and Commercialize Agreement Compounds.

Licensor Patent Right means all Patent Rights Controlled by Licensor as of the Effective Date or during the term, as are reasonably necessary to Develop, make, have made, use, import or export Agreement Compounds, or to make, have made, use. offer to sell, sell, import, export or otherwise Commercialize Products based thereon; provided, however, that if a Third Party becomes an Affiliate of Licensor pursuant to a Change of Control Transaction as a result of which such Third Party is able to elect a majority of the members of the board of directors of Licensor (or its successor company) or any of its 'controlling Affiliates' (Change of Control Transaction), 'Licensor Patent Rights' not include any Patent Rights that were Controlled by such Third Party (and not by Licensor) prior to the completion of such Change of Control Transaction.  It is understood that Licensor Patent Rights shall not include any intellectual property owned or licensed by Licensor relating to (i) the creation or use of encoding technology for combinatorial libraries, (ii) tag and/or marker compound engineering, encoding or decoding, or (iii) high throughput screening assays.

Licensor Available Compound means
(a)  any Licensor Compound or Collaboration Compound selected by Licensor for Development (Compound Selection) and for which Licensor is fulfilling the diligence obligations required (Compound Selection); and (b)  any Licensor Compound or Collaboration Compound with respect to which Licensor has undertaken Development in the Licensee Field if permitted and for which Licensor is fulfilling the diligence obligations required (Compound Selection).

Patent Rights means any and all (a) patents, (b) pending patent applications, including, without limitation, all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, and all patents granted thereon, (c) all patents-of-addition, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including, without limitation, supplementary protection certificates or the equivalent thereof (d) inventor’s certificates, and (e) all United States and foreign counterparts of any of the foregoing.

Product(s) means Licensor Product(s) or Licensee Product(s), as the case may be.

Licensor Product means a pharmaceutical preparation containing a Licensor Available Compound.  For purposes of clarity, any pharmaceutical preparations containing the same Licensor Available Compound will be deemed to be the same Licensor Product.

Licensee Product means a pharmaceutical preparation containing a Licensee Available Compound.  For purposes of clarity, any pharmaceutical preparations containing the same Licensee Available Compound will be deemed to be the same Licensee Product.  For the avoidance of doubt, a Licensee Product will not be considered to be separate, distinct and different from another Licensee Product solely on the basis of its use for a different indication, method of production or manufacture, method of delivery or dosage level.

Field of Use

JAK3 Inhibitors. A member of the Janus family of tyrosine protein kinases, Janus Kinase-3 (JAK3) plays a critical role in T-cell proliferation via cytokine signaling pathways. Local administration of a selective JAK3 inhibitor represents a potential therapeutic approach for T-cell and cytokine mediated dermatologic and ocular diseases. Included in these are psoriasis, which is characterized by hyper-proliferation of T-cells which present themselves in inflamed skin lesions, and dry eye which is a cytokine-based inflammation of the ocular surface.

Licensor Field means all uses of a Product in non-human animals, and all topical uses of a Product for the treatment or prevention of skin and eye diseases in humans where such Product would be applied directly to the skin or eye and would have its therapeutic effect at or near a target site on the skin or eye.

License Grant

Licensor hereby grants to Japanese Licensee, under the Licensed Technology, an exclusive, royalty-bearing license, with the right to grant sublicenses, to develop, have developed, make, have made, use, sell, offer for sale and import Licensed Products within the Licensed Field in the Licensee Territory.

License Property

Licensed Product shall mean
          (i)   any Clinical Candidate (as defined in the Collaboration Agreement);
          (ii)  any compound (a) which is identified, developed or discovered by Licensee using Licensed Technology and (b) which acts through activation of the insulin signal transduction pathway for the treatment of diabetes mellitus or insulin resistance in humans; and
          (iii) any compound which is an analog, homolog or chemical modification of a compound described in clause (i) or (ii) and which acts through activation of the insulin signal transduction pathway for the treatment of diabetes mellitus or insulin resistance in humans.

Licensed Technology shall mean the Licensed Patent Rights and the Licensed Know-How.

Licensed Patent Rights shall mean all of (i) Licensors interest in any patents and patent applications (including any divisions, continuations-in-part, reissues, extensions, renewals, supplementary protection certificates and foreign counterparts thereof) covering inventions made in the course of the Research Program (the Research Program Patents) and (ii) other patents and patent applications (including any divisions, continuations-in-part, reissues, extensions, renewals, supplementary protection certificates and foreign counterparts thereof) owned or Controlled by Licensor, but only to the extent such other patents and patent applications are necessary or useful for Licensee for the manufacture, use, sale, offer for sale or import of Licensed Products which are covered by the Research Program Patents.

Field of Use

License is for the development of a Type II diabetes drug.  The molecular fingerprinting is a family of small molecules that have demonstrated they can bind to and activate the insulin receptor to lower blood glucose levels in diabetes patients.

License Grant

The University Foundation grants to Licensee the exclusive right and license to make, have made, use, import, offer for sale, and sell in the Territory, Licensed Products during the term of this Agreement including Licensee’s right to grant sublicenses.

The license granted is subject to a reserved, non-exclusive license of Foundation, transferable to University and its not-for-profit academic collaborators, to practice the Licensed Patents in the Field, only for the purpose of non-commercial scientific inquiry, academic research, and education.

License Property

Licensed Product means any compound, product, service, or process in the Field, the manufacture, use, or sale of which, but for the license granted herein, would infringe at least one Valid Claim.

Licensed Patents means (i) the patent applications listed, (ii) the United States patents that may issue from the patent applications listed and from divisionals and continuations and continuations-in-part of such United States patents and patent applications, (iii) all foreign counterparts of such patent applications, and all patents that issue thereon anywhere in the world, including reexamined and reissued patents. Licensed Patents shall also mean any patent application having claims in the Field directed to an invention made in the laboratory of Dr. Vasu Nair six months or less prior to the Effective date, and (iv) with respect to the matters described in clauses (i), (ii) and (iii) above, all provisionals, renewals, re-examinations, patents of addition, supplementary protection certificates, extensions, restorations of patent terms, letters of patent, registration or confirmation patents and reissues of such patents or patent applications.

7,250,421 – Diketo acids with nucleobase scaffolds anti-HIV replication inhibitors targeted at HIV integrase

Indication shall mean the prevention, treatment or diagnosis of a condition, infection or disease caused by or associated with a specific virus in the Field. For example HIV Indication means the prevention, treatment or diagnosis of a condition, infection or disease caused by or associated with Human Immunodeficiency Virus (HIV) and HCV Indication means prevention, treatment or diagnosis of a condition, infection or a disease caused by or associated with Hepatitis C Virus (HCV).

Field of Use

Field means any and all anti-viral uses, including but not limited to prophylaxis, diagnosis or treatment of a condition, infection or disease associated with a virus, except the Field specifically excludes any anti-viral use associated with (a) the following DNA virus families  poxviridae, polyomaviridae, papillomaviridae, adenoviridae, and parvoviridae; and (b) all RNA viruses except for the following RNA virus families, which are specifically included in the Field  retroviridiae (for example HIV as defined below), flaviviridae (for example HCV as defined below), orthomyxoviridae, paramyxoviridae, and coronaviridae. In the event that Licensee terminates the Sponsored Research Agreement (“SRA”), a copy of which is attached as Appendix J, pursuant to paragraph 16(d) of the SRA, the Field of this License Agreement shall automatically be amended to exclude HCV.

License Grant

For the Exclusive License Grant, the Licensor of Scotland, operating in the United Kingdom, grants  an exclusive, even as to Licensor, license under the Patent Assets and the Licensor Know-How to develop, make, have made, use, import, offer for sale, market, commercialize, distribute and sell and otherwise dispose of Compound and Product in the Territory. The exclusive license granted includes the right to grant sublicenses.

And, for the Exclusive License Grant, Licensor grants an exclusive license to use and exploit the NOS Patent Assets and the Licensors NOS Know-How to develop, make, have made, use, import, offer for sale, market, commercialize, distribute and sell and otherwise dispose of the NOS Inhibitor Technology and any NOS Inhibitor and the Split Dose Patent Assets and the Licensors Split Dose Know-How to develop, make, have made, use, import, offer for sale, market, commercialize, distribute and sell and otherwise dispose of Compound or Product using the Split Dose Technology, each solely in connection with the use of Compound and/or Product in the Territory.  The exclusive license granted includes the right to grant sublicenses.

License Property

The rights are to a series of novel vascular targeting agents for cancer treatment from Licensor.  The targeting agents are known as the ANG-600 series.

The Product shall mean any product in final form for commercial sale by prescription, over-the-counter, or by any other method, or, where the context so indicates, the product being tested in clinical trials, which contains Compound as at least one of the therapeutically active ingredients, in all final dosage forms and package configurations for any indication, or any line extension thereof.

The Compound shall mean the chemical compounds known as benzimidazole carbamate class vascular targeting agents,including those designated ANG-600 Series, whose more specific chemical names are 5 (6) substituted benzimidazole-2-carbamates, and any derivative, homolog, analog or conjugate of any of the foregoing, and any isomer, salt, hydrate, solvate, metabolite, or prodrug or the like of any of the foregoing.

The NOS Inhibitor shall mean a chemical composition that inhibits the formation or action of nitric oxide, including those disclosed in the NOS Patent Assets.

NOS Inhibitor Technology shall mean technology relating to the combination of vascular targeting agents, including Compound, and an NOS Inhibitor, including the inventions disclosed in the NOS Patent Assets.

NOS Patent Assets shall mean United States and foreign patents and patent applications, which shall be deemed to include certificates of invention and applications for certificates of invention, which as of the Effective Date or at any time during the term of this Agreement
– are owned by Llicensor (including Licensors interest in jointly owned patents and patent applications) or which Licensor through license or otherwise has or acquires rights, and
– relate to the combination with Compound or Product of an NOS Inhibitor or the NOS Inhibitor Technology including but not limited to methods of their manufacture, methods of their use, or otherwise relate to Licensor NOS Know-How, including all certificates of invention, divisions, continuations, continuations-in-part, reissues, supplementary protection certificates or the like of any such patents and current and future patent applications.

Split Dose Patent Assets shall mean United States and foreign patents and patent applications, which shall be deemed to include certificates of invention and applications for certificates of invention, which as of the Effective Date or at any time during the term of this Agreement
– are owned by Licensor including Licensors interest in jointly owned patents and patent applications or which Licensor through license or otherwise has or acquires rights, and
– relate to the use of Compound or Product in divided doses including but not limited to methods of their manufacture, methods of their use, or otherwise relate to Licensor Split Dose Know-How, including all certificates of invention, divisions, continuations, continuations-in-part, reissues, supplementary protection certificates or the like of any such patents and current and future patent applications.

The Split-Dose Technology shall mean a method of administering any vascular damaging agent in a divided dose, including the inventions disclosed in the Split-Dose Patent Assets.

Field of Use

The application of the product is novel vascular targeting agents for cancer treatment.