Royalty Report: Drugs, HIV / AIDs, Cancer – Collection: 372475

License Grant

Licensor grants an exclusive, sub-licenseable, non-transferable license, under the Licensor IP and Licensor s interests in the Joint IP, to make, have made, use, sell, offer for sale and import Licensed Compounds and Products in the Field in the Territory.

License Property

Product means any pharmaceutical product containing one or more Licensed Compound as an active pharmaceutical ingredient.

Licensed Compound means any NNRTI, a non-nucleoside reverse transcriptase inhibitor, compound claimed in the Licensor Patent Rights, including those referenced as X-1008, X-1020. X- 1041, X-1050, X-1067, X-1068 and X-1069 and/or all continuations, divisions, reexaminations, renewals, registrations, reissues and extensions of any of the foregoing Patent Rights, both foreign and domestic, that are Controlled by Licensor during the Term, including X899 and X989 and all back-up compounds, follow-on compounds, prodrugs and metabolites of such compounds, as well as their isomers, salts, hydrates, solvates and polymorphs.

– X899 means (2-Carbamoyl-5-chloro-l H-indol-3-yl )-[3-( (E)-2-cyano-vinyl )-5-methyl-phenyl ]-phosphinic acid methyl ester, stereoisomers or salts thereof.

– X989 means (2-Carbamoyl-5-chloro-4-fluoro-lH-indol-3-yl)-[3-{(E)-2- cyano-vinyl)-5-methyl-phenyl]-phosphinic acid methyl ester, strereoisomers or salts thereof.

The patents relate to Phosphoindoles
– Phospho-indole as HIV Inhibitors
– Enantiiomerically Pure Phosphoindoles as HCV and HlV Inhibitors
– Dual Release Formulation of Phosphoindole Compound

IDX899 is a potent non-nucleoside reverse transcriptase inhibitor (NNRTI) being developed for the treatment of HIV-1. Licensor has advanced IDX899 through a Phase II proof-of-concept study in HIV-1 infected treatment-naïve patients that was completed in 2008

Field of Use

IDX899 is a novel non-nucleoside reverse transcriptase inhibitor (NNRTI) in Phase II clinical development being developed by Idenix for the treatment of HIV/AIDS.  New NNRTIs are needed to address the increasing prevalence of viral resistance and side effects associated with this drug class. To date, IDX899 has demonstrated high potency with low milligram doses, a high barrier to drug resistance, favourable risk/benefit profile, and the convenience of once-a-day administration.

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

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.

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.