Royalty Report: Drugs, Therapeutic, Diagnostic – Collection: 227291

The heparin assay, anti–factor Xa assay, is designed to measure plasma heparin (UH and LMWH) levels and to monitor anticoagulant therapy. Heparin is a mixture of negatively charged glycosaminoglycans (sulfated mucopolysaccharides) that have anticoagulant properties due to their interaction with the natural anticoagulant antithrombin.

The Diagnostic Field shall mean clinical diagnostics using the Heparinases for in vitro testing of external tissue samples from patients.

Research Reagent Field shall mean research reagent uses of the Heparinases designated for research purposes only, not to be used in humans.

The Therapeutic Field shall mean human use of the Heparinases as therapeutics in pharmaceutical  compositions for reversal of anticoagulants, inflammation, reperfusion injury, restenosis and wound healing.

The original agreement patent rights are for Heparin and Masspec for Field all but Machines;  for Case 9180 for Field Therapeutics;  for Case 9180 Background to enable and only to enable the practice of patent rights Case 9180; and patent rights Heparinase for Field Heparinase.

University grants a first option to add Improvement to the Patent Rights, only in the fields for which exclusive rights, for six months after Company has been notified of the existence of each such Improvement.

Patent titles include Solid-and Solution-Phase Synthesis of Heparin and Other Glycosaminoglycans;  
Synthesis of Oligosaccharides in Solution and on the Solid Support;  Linkers for Synthesis of Oligosaccharides on Solid-Support;  Protecting Groups Useful in the Synthesis of Polysaccharides, Natural Products, and Combinatorial Libraries;  Apparatus and Methods for the Automated Synthesis of Oligosaccharides;   Rationally Designed Heparinases Derived from Heparinase I and II;   System and Method for Notating Polymers;  and, Method for Identifying or Characterizing Properties of Polymeric Units.

The Field Therapeutics shall mean for internal use in the discovery and development of therapeutic compounds;  and,  the clinical testing, manufacture and sale of therapeutic compounds.  This field shall not include the sale of research reagents or of synthesis machines.

The Field Heparinase shall mean all fields of use except for human use of heparinases as therapeutics in pharmaceutical compositions and except for Field Sequencing Machines.

The Licensor hereby grants to the Company the right to grant sublicenses to third-parties.

Primary Field means therapeutic, prophylactic, or diagnostic health care applications for amyotrophic lateral sclerosis (ALS), diabetes, and obesity, in humans.

Secondary Field means therapeutic, prophylactic, or diagnostic health care applications in humans that are not included in the Primary Field.

Warfarin sensitivity testing (genotyping) may be used to help determine someone's likely sensitivity or, less commonly, resistance to warfarin and to help select appropriate doses. Warfarin is an anticoagulant, a drug that is prescribed to help prevent inappropriate blood clotting (thrombosis and thromboembolism) in people who are at risk, or to help keep an existing blood clotting condition from getting worse.

Licensee is a molecular diagnostics company focused on developing and commercializing our eSensor detection technology.

University grants to Licensee a first option to add improvements to the Patent Rights, only in the fields for which exclusive rights are granted.

Licensed Product shall mean any sequencing machine that, in whole or in part absent the license granted hereunder, when used would infringe one or more claims of the Patent Rights.

Heparanase, also known as HPSE, is an enzyme that acts both at the cell-surface and within the extracellular matrix to degrade polymeric heparan sulfate molecules into shorter chain length oligosaccharides.

Licensee is also utilizing our ability to sequence, or analyze the molecular structure of, sugars, to create generic versions of complex sugar-based drugs, or technology-enabled generic products. Through detailed analysis of the molecular structure of complex sugars, our technology provides a more complete understanding of the roles that sugars play in cellular function, disease and drug action. Based on our understanding of complex sugars, Licensee has developed a diversified pipeline of novel discovery and development candidates and near-term product opportunities.

The parties agreed to amend the agreement to expedite the expansion of our Phase 4 trial of Andexxa.  The original agreement was entered into to study the safety and efficacy of Andexxa as a reversal agent to edoxaban, in our Phase 3 and Phase 4 studies.  The Licensee is responsible for the cost of conducting these clinical studies. Pursuant to our agreement with Licensor, Licensee is obligated to provide research, development and regulatory services and to manufacture and supply Andexxa.

AndexXa (andexanet alfa), an investigational drug, is a modified human Factor Xa molecule that acts as a decoy to target and sequester with high specificity both oral and injectable Factor Xa inhibitors in the blood. Once bound, the Factor Xa inhibitors are unable to bind to and inhibit native Factor Xa, thus potentially allowing for the restoration of normal hemostatic processes. AndexXa is the first compound being studied as an antidote for Factor Xa inhibitors that directly and specifically reverses anti-Factor Xa activity – the anticoagulant mechanism of these agents.

Licensee is developing andexanet alfa, a U.S. Food and Drug Administration (FDA)-designated Breakthrough Therapy, for patients treated with a direct or indirect Factor Xa inhibitor when reversal of anticoagulation is needed, such as for life-threatening or uncontrolled bleeding or emergency surgery and urgent procedures.