Royalty Report: Drugs, Diagnostic, Biotechnology – Collection: 27234

License Grant

Licensee entered into that certain License Agreement with the University pertaining to an invention entitled, External Guide Sequences for an RNA Enzyme.

License Property

One of these core technologies is designed to utilize Innovir's proprietary EGS ('External Guide Sequence') Oligozyme technology to direct a cellular ribozyme to disease-causing RNA, so that the ribozyme will cleave the RNA and thus render it inactive. An EGS Oligozyme is a small, chemically modified oligonucleotide segment that binds to a disease-causing RNA to create a structure resembling a type of RNA which is cleaved by a specific ribozyme in cells. This naturally occurring cellular ribozyme, called RNase P, has been harnessed to cleave such newly formed structures, thereby destroying the disease-causing RNA molecules before they can be used to create disease-causing proteins.

Patent No. 5,168,053

Field of Use

The rights granted apply to the Licensed Patents.

License Grant

Licensor hereby grants to Israeli Licensee a world-wide, exclusive license, with the right to sublicense within the Field, under the Licensor Technology to make ribozymes only for research purposes and to develop, use, make and have made and sell Semi-finished Products, Products or perform Licensed Services against Target Diseases provided, however, Licensee shall have the right to sell Semi-finish Products only to Corporate Partners which have entered into a sublicense with Licensee. Licensees right to make or have made Semi-finished Products, Products and perform Licensed Services shall be subject at all times to Licensors exclusive right to manufacture and supply Ribozymes for those purposes. Nothing contained herein shall be construed as granting a license, implied or otherwise, to Licensee or any third party to manufacture Ribozymes using the Licensor technology except under the conditions and as specifically set forth.

License Property

Licensor Technology shall mean the issued patents identified below, and foreign counterparts thereof as well as all U.S. and foreign patents issuing therefrom, including any continuations or continuations-in- part, divisions, reissues, renewals and extensions thereof, and any additions thereto issued within 10 years of the date hereof, and registrations and licenses.
US 4,987,071 – RNA Ribozyme Polymerases, Dephosphorylases, Restriction Endoribonucleases and Methods
US 5,037,746 – RNA Ribozyme Polymerases and Methods
US 5,093,246 – RNA Ribozyme Polymerases, Dephosphorylases, Restriction Endoribonucleases and Methods

Ribozyme shall mean a nucleic acid molecule capable of catalyzing reactions including, but not limited to, site-specific cleavage and/or ligation of other nucleic acid molecules, cleavage of peptide and amide bonds, polymerization and transsplicing.

Ribozymes For Research shall mean Ribozymes required by Licensee for purposes of research and development of a Semi-finished Product, Product or Licensed Service, including those required under a Work Plan approved by Licensor.

Ribozymes For Products shall mean Ribozymes used in Semi-finished Products, Products or Licensed Services.

Product shall mean products designed, developed, and sold against a Target Disease by Licensee (or Licensor in the event of a reversion), or an Affiliate, Collaborator or Corporate Partner and which is generally in finished form and ready for end use without further substantial chemical alteration.

Licensed Services shall mean any service within the Field, other than the development, production and sale of a Product or Semi-finished Product, which is performed for a third-party by Licensee, an Affiliate or a sublicensee hereunder, and which includes use of a Semi-finished Product or Product or any invention, method, process, procedure or technology which is included, in whole or in part, in Licensor Technology.

Target Disease shall mean any one of the human diseases conditions for which a Work Plan has been approved by Licensor.

Semi-finished Product shall mean ribozymes or products which have not been substantially transformed by Licensee or an Affiliate into a Product and which are transferred to a Corporate Partner in an arms length transaction for the purpose of sales of Products and/or Licensed Services.

Field of Use

Field shall mean in vitro diagnostics for the diagnosis of Target Disease using Ribozymes in Amplified Nucleic Acid Formats.

License Grant

Licensor grants the Japanese Licensee a license under and to Licensor Technology to Develop and Commercialize the Licensed Product in the Field in the Licensee Territory. Such license is exclusive for the Royalty Term of the Licensed Product in each country in the Licensee Territory, and shall thereafter be a non-exclusive, fully-paid license to Develop, Manufacture and Commercialize the Licensed Product in the Field in such country.

For the Manufacturing License, Licensor grants a non-exclusive license under Licensor Technology solely for the purpose of Manufacturing the Licensed Product for the Licensee Territory and Licensee grants Licensor a non-exclusive license under Licensee Technology to Manufacture the Licensed Product.

License Property

Licensor owns or controls certain fundamental intellectual properties relating to RNA interference, and is developing therapeutic products targeting respiratory syncytial virus (RSV) that function through RNA interference, including the proprietary Licensor product known as ALN-RSV01.

Antisense Product means a single-stranded oligonucleotide or analog thereof having a specific sequence that inhibits protein synthesis at the nucleic acid level by specifically binding to the sequence of a messenger or viral ribonucleic acid (RNA) by base-pairing, thus causing selective inhibition of gene expression.

The patents include, but are not limited to; RNA interference is mitigated by 21 and 22nt small RNAs;  RNA interference mediating small RNA molecules;  RNA sequence-specific mediators of RNA interference; and, Inhaled treatment for RSV.

Field of Use

Licensee enters this agreement for the treatment of respiratory infections in humans caused by RSV, in Japan and certain other countries in Asia.
RSV is a highly contagious virus that causes infections in both the upper and lower respiratory tract.

License Grant

This amendment clarifies certain definitions and modifies the royalty rates.

In the original restated license, Licensor grants a world-wide exclusive license under Licensed Patents and Licensed Know-How, to make, use, offer to sell, sell and import Licensed Products in the Exclusive Licensed Field.

License Property

Licensor has certain know-how relating to the synthesis of MGB Oligonucleotides, including MGB Oligonucleotides containing modified bases, and the design of sequence-specific probes comprising such oligonucleotides.  MGB Oligonucleotide means Licensed Product comprising an oligonucleotide having a minor-groove binding moiety covalently attached.

The licensed know-how includes chemical structures, manufacturing methods and Algorithms, object code, source code and any other embodiments of methods or processes useful for predicting the melting temperature of MGB Oligonucleotides, whether patented, copyrighted, or not.

Field of Use

The Exclusive Licensed Field means the 5’-Nuclease Assay Field.  The 5’-Nuclease Assay Field means the detection of a nucleic acid sequence based on the cleavage of a nucleic acid probe that is hybridized to the nucleic acid sequence by a 5’ to 3’ nuclease activity of a polymerase enzyme.