Royalty Report: Drugs, Antibiotic, Drug Discovery – Collection: 237248

University grants to Licensee the right to enter into sublicensing agreements.

This agreement also includes a non-exclusive grant back to University from Licensee.

First Licensed Product means the first federally approved Individual Licensed Product to be subjected to a governmental safety and efficacy approval process prior to market introduction, and which is sold in any country of the Territory.

Licensor grants an exclusive and non-transferable license to use the Trademark for or in connection with sale and promotion of the Product in the Territory, and Licensee agrees to use the Trademark for such purpose.

The term API shall mean Compound in amorphous powder form ready to be formulated.

The term Compound shall mean a cephalosporin antibiotic known as Cefditoren Pivoxil.

The term Trademark shall mean SPECTRACEF® .

Cefditoren is used in the treatment of infections caused by bacteria. It works by killing bacteria or preventing their growth. Cefditoren pivoxil is used to treat some throat and lung infections, including bronchitis and tonsillitis. It is also used to treat some skin infections.

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

Active Pharmaceutical Ingredient or API means Gemifloxacin in active bulk.

Licensor Licensed Patents include but is not limited to
– Dimethane-sulfonate salt of certain pyrrolidinium compounds and the process for the
prearation thereof and the process for the preparation of gemifloxacin free base or salts using AM 19.
– The process for direct salt  and hydrate formation of gemifloxacin mesylate sesquihydrate using a water-miscible cosolvent and water.
– The process for gemifloxacin free base or salts using an agueous solvent.
– Combination Therapy (gemifloxacin and B-lactam).
– Combination Therapy (gemifloxacin and carbapenem).

The trademarks are FACTIVE, FACTIVE DEV, FACPAC3DAY, FACPAC7 and dev., and FAST. ACTIVE. FACTIVE.

DNA nanobinder compounds are compounds that exhibit significant antibacterial activity, have at least one heteroaromatic carboxamide unit, are first synthesized in an internal GS research program (including research programs funded by the United States government but excluding collaborative research programs with a non-governmental third party) and typically but not necessarily bind to the minor groove of double-stranded DNA with an affinity in the nanomolar range.

Collaboration Compound shall mean any composition of matter in the field (or in the case of pro-drugs, an active metabolite of which), other than a natural product or synthetic or semi-synthetic derivative thereof, that (i) was discovered, identified, synthesized or acquired by or on behalf of Licensor as of the effective date, (ii) is discovered, identified, synthesized or acquired by or on behalf of Licensor during the research term and for six (6) months thereafter, or (iii) is contained within a chemical genus as defined in any issued claim of any unexpired patent in the patent rights, or in a claim of a pending application for such a patent which is being prosecuted in good faith, and as to which one member of such chemical genus is defined in (i) or (ii) above. For purposes of determining whether a given composition is a collaboration compound, it is understood that a composition which is discovered, identified, synthesized or acquired during the research term or within six (6) months thereafter (the Applicable Date) shall be included as a collaboration compound notwithstanding whether the composition was identified as being active in the field after the Applicable Date.

Development shall mean all work involved in Phases O, I, II, and III for a Licensed product in any country or territory.

U.S. Serial No. 08/377,583 – Screening Procedure for Penicillin-binding protein inhibitors.

Research Program shall mean all research and development performed, directed or acquired by Licensor in the course of performing the research plan during the research term.

Licensor is a biopharmaceutical company founded to discover, develop and commercialize novel antibiotics for the treatment of serious bacterial infections. The Companys discovery and development programs address the growing problem of bacterial drug resistance through two principal themes (i) Targeted Antibiotics, which focuses on developing novel antibiotics and antibiotic potentiators, and (ii) Targeted Genomics, which utilizes bacterial genetics to discover new classes of antibiotics and other novel treatments for bacterial disease.

The targeted Antibiotics programs seek to rapidly develop clinically useful antibiotics tailored to treat specific bacterial infections, as well as antibiotic potentiators, which will overcome resistance pathways and restore usefulness to existing antibiotics that have been rendered ineffective. The specific problematic bacteria being addressed (staphylococci, enterococci, Pseudomonas aeruginosa and Streptococcus pneumoniae) are responsible for 44% of the approximately two million hospital-acquired infections occurring annually in the United States.

Field shall mean the field of
(i) cephalosporin antibiotics active against Gram-positive bacteria with MICs (minimum inhibitory concentrations) of ~ 32,/g/ml against staphylococci, enterococci and pneumococci, as determined by NCCLS recommended methods;
(ii) novel compounds and compositions which react with penicillin binding protein, including but not limited to PBP2a, with an ICso ! 50,/g/ml in a standard penicillin binding protein assay, provided that research activities are initiated in this ponion of the field prior to start of the nineteenth (19th) month of the research term;
(iii) non-antibacterial beta-lactam or glycopeptide antibiotic potentiators, including specifically, but not limited to, compounds that exen their e~ect primarily by inhibition of methicillin and vancomycin resistance mechanisms, and potentiators that exen their effect primarily by inhibition of histidyl-aspartyl two component switch regulatory system in bacteria, which non-antibacterial beta-lactam or glycopeptide antibiotic potentialOr exhibits MICs (minimum inhibitory concentrations) alone, against staphylococci, enterococci and pneumococci of ~32ys/ml. as determined by NCCLS recommended methods, but not including (a) quinolone potentiators or (b) potentiators or antibacterials which work primarily by inhibition of bacterial efflux pumps, or (c) beta-lactamase inhibitors ;
(iv) compounds or compositions discovered through the use of genes, gene products and Licensor screens in the Agr (accessory gene regulator) pathway of Staphylococcus aureus, or functionally homologous genes in other Gram-positive organisms, in either instance including histidyl-aspartyl two component switch regulatory systems in the Agr pathway;
(v) antibiotics which act through the histidyl-aspartyl two component switch regulatory system discovered using Licensor know-how developed in performance of the research program during the research term, or within six (6) months thereafter (i.e., new hits and leads and new discovery screens for histidine protein kinase inhibitors developed during the course of the research program), with MICs (minimum inhibitory concentrations) of~16/lg/ml against Gram-positive and/or Gram-negative organisms, as determined by NCCLS recommended methods, all for use in treating bacterial infections for all human and animal pharmaceutical applications.

Licensee has been engaged in research efforts focused on the development of new antibacterials and has certain research, development and commercialization capabilities in the field.

Licensor grants the nonexclusive license, under the Licensor Technology, to practice and use the Licensor Technology and the Licensed Products anywhere in the world for the sole purpose of engaging in those research and development activities that Licensee is expressly required or permitted to perform pursuant to this Agreement.

Licensor grants a nonexclusive license, under the Licensor Technology, to make, have made, manufacture and have manufactured anywhere in the world Licensed Products for sale in the Territory.

For the Trademark License,  Licensor grants an exclusive license under its entire right, title and interest in and to the Licensor Marks to use and display the Licensor Marks in connection with the Commercialization of Licensed Products within the Territory.

Daptomycin shall mean the molecule identified as the daptomycin molecule and all acids, salts and esters of such daptomycin molecule.

Daptomycin IV Product shall mean any pharmaceutical composition containing Daptomycin in all current and future formulations, but only if such pharmaceutical composition is formulated for delivery via Injection.  

Additional Daptomycin Product shall mean any pharmaceutical composition containing Daptomycin other than a Daptomycin N Product.

The mark is Cidecin or Cubicen. CUBICIN® daptomycin for injection, an intravenous, or I.V., antibiotic

Daptomycin is an antibiotic used to treat bacterial infections of the skin and underlying tissues.  Daptomycin is a lipopeptide antibiotic used in the treatment of systemic and life-threatening infections caused by Gram-positive organisms.