Royalty Report: Diagnostic, Scientific & Technical Instruments, Device – Collection: 372490

License Grant

For the Exclusive License in Licensee e-Detection, Licensor grants an exclusive, even as to Licensor, but subject to the license back to Licensor, right and license, under the under the Licensor IP Rights and Licensor’s interest in Joint Collaboration IP Rights, to make, have made, use, sell, offer for sale, and import in the Territory those Licensed Products utilizing Licensee e-Detection for use in the Field.

For the Exclusive License in Molecular Analyte Field, Licensor grants an exclusive, even as to Licensor, but subject to the license back to Licensor, right and license, under the under the Licensor IP Rights and Licensor’s interest in Joint Collaboration IP Rights, to make, have made, use, sell, offer for sale, and import in the Territory those Licensed Products utilizing Electrochemical Detection and capable of a throughput of 3 or more simultaneous samples for use in the Molecular Analyte Field.

For the Non-Exclusive License for Enzyme Labels, Licensor grants a non-exclusive right and license, under the under the Licensor IP Rights and Licensor’s interest in Joint Collaboration IP Rights, to make, have made, use, sell, offer for sale, and import in the Territory those Licensed Products utilizing Electrochemical Detection with an Electrochemical Label that is an enzyme and capable of a throughput of 3 or more simultaneous samples for use in the Protein Analyte Field.

Licensee shall have the option to obtain an exclusive right and license, under the Licensor IP Rights and Licensor’s interest in Joint Collaboration IP Rights, to make, have made, use, sell, offer for sale, and import in the Territory those Licensed Products utilizing Licensees e-Detection for use in the Other Analyte Field the Option.

License Property

Licensor has developed, and owns or controls certain intellectual property and other rights to, a fluidics technology using the electrowetting effect as a motive force for conducting droplet operations.

Licensee has developed, and owns or controls certain intellectual property and other rights to, technologies related to the electrochemical detection of analytes and to the use of electrochemical detection in in-vitro diagnostics.

Licensor Collaboration Inventions means those Collaboration Inventions that relate solely to Digital Microfluidics and Collaboration Inventions that are apparatuses or methods that relate solely to Digital Microfluidics.

Complex means a complex comprising a capture ligand coupled to an electrode surface, a target analyte, and an Electrochemical Label.

Diagnostic Testing means testing for the purpose of diagnosis, prognosis, monitoring, screening or predicting a disease or condition in a human, or selecting a therapeutic or prophylactic regimen; excluding screening of newborn infants for metabolic or other disorders in fields other than in the Molecular Analyte Field using Licensee e-Detection.

Digital Microfluidics means the control of the movement, including the transport, splitting, dispensing, merging or deforming, of droplets by electrical fields.

Licensees e-Detection means the detection of an analyte based on a Complex where the Electrochemical Label is detected using Electrochemical Detection.

Licensed Products means a product for use in Diagnostic Testing, including Instrument Licensed Products and Consumable Licensed Products.

Field of Use

The Field means the Protein Analyte Field and Molecular Analyte Field, and subject to exercise of the Option, the Other Analyte Field.

Protein Analyte Field means in-vitro Diagnostic Testing of samples from or derived from human subjects using Licensee e-Detection of a protein and/or peptide analyte.

Molecular Analyte Field means in-vitro Diagnostic Testing of samples from or derived from human subjects using Electrochemical Detection of a DNA, RNA or other nucleotide sequence analyte, excluding testing utilizing Sequencing.

Other Analyte Field means in-vitro Diagnostic Testing of samples from or derived from human subjects using Licensees e-Detection of an analytes other than
— proteins and/or peptides and
— DNA, RNA or other nucleotide sequences.

License Grant

Licensor grants to Licensee and its Affiliates a limited non-exclusive, personal and non-transferable, right and subLicense under the Licensed Patents, to make, have made for its own use and sale, use, offer to sell, sell and import product within the field and within the territory, and to practice the methods claimed in the Licensed Patents in connection with such product, and to extend to its customers purchasing product the right to use and sell the product purchased and to practice the methods claimed in the Licensed Patents in connection with such product.

License Property

Licensed Patent shall mean United States Patent Nos. 5,073,484, 5,654,162 and 6,020,147 and any patents resulting from a re-examination or reissue from any of the foregoing patents.

The patents are for a device for detecting the presence of an analyte in a carrier liquid suspected of containing said analyte, which device comprises a liquid permeable solid medium which defines a path for fluid flow capable of supporting capillary flow, along which are a site for application of the carrier liquid, a diffusively bound labeled reactant specific for the analyte or a chemical moiety which is itself the reaction product of the analyte with another chemical moiety, said labeled reactant being capable of flow along the flow path, wherein said diffusively bound labeled reactant and said analyte or chemical moiety are of a specific ligand-anti ligand pair, and one or more zones spaced along said flow path, each zone having a predetermined amount of a reactant bound to it which is specific for either the analyte or a chemical moiety which is itself the reaction product of the analyte with another chemical moiety.

Wherein said device can be used by contacting a carrier liquid with said application site in such a manner that permits said liquid to pass along the flow path by capillary flow such that analyte or reaction product of the analyte with another chemical moiety becomes bound to both the labeled reactant and the reactant bound to the solid medium;  and wherein the labeled reactant, with the reactant bound to the solid medium, sandwiches the analyte or a chemical moiety which is itself the reaction product of the analyte with another chemical moiety.

Lateral flow tests also known as lateral flow immunochromatographic assays, are simple devices intended to detect the presence (or absence) of a target analyte in sample (matrix) without the need for specialized and costly equipment, though many lab based applications exist that are supported by reading equipment.[2] Typically, these tests are used for medical diagnostics either for home testing, point of care testing, or laboratory use.

License Grant

The company hereby grants an exclusive, royalty-bearing, worldwide license and sublicense (with the right to further sublicense) to use the Subject Technology solely within the Field of Use to develop, make and have made, use, sell, offer for sale, import, market and otherwise commercially exploit all Products in all markets.

License Property

Serial No.

Patent No.

1
METHOD AND APPARATUS FOR DESORPTION AND IONIZATION OF ANALYTES
AU
70483/94

676582

2
METHOD AND APPARATUS FOR DESORPTION AND IONIZATION OF ANALYTES
NZ
267842

267842

3
METHOD AND APPARATUS FOR DESORPTION AND IONIZATION OF ANALYTES
US
08/483,357

5,719,060

4
SURFACE-ENHANCED NEAT DESORPTION FOR DESORPTION AND DETECTION OF ANALYTES
US
08/785,637

5,894,063

5
SYSTEMS FOR SURFACE-ENHANCED AFFINITY CAPTURE FOR DESORPTION AND DETECTION OF ANALYTES
US
08/556,951

6,020,208

6
SURFACE-ENHANCED AFFINITY CAPTURE FOR DESORPTION AND DETECTION OF ANALYTES
US
08/785,636

6,027,942

7
SURFACE-ENHANCED NEAT DESORPTION AND DETECTION OF ANALYTES
US
09/095,407

6,124,137

8
USE OF RETENTATE CHROMATOGRAPHY TO GENERATE DIFFERENCE MAPS
US
09/100,302

6,225,047

9
RETENTATE CHROMATOGRAPHY AND PROTEIN CHIP ARRAYS WITH APPLICATIONS IN BIOLOGY AND MEDICINE
SG
9906243-2

69803

10
RETENTATE CHROMATOGRAPHY AND PROTEIN CHIP ARRAYS WITH APPLICATIONS IN BIOLOGY AND MEDICINE
JP
11-504918

3287578

11
RETENTATE CHROMATOGRAPHY AND PROTEIN CHIP ARRAYS WITH APPLICATIONS IN BIOLOGY AND MEDICINE
NZ
501837

501837

12
RETENTATE CHROMATOGRAPHY AND  PROTEIN CHIP ARRAYS WITH APPLICATIONS IN BIOLOGY AND MEDICINE
NZ
501838

501838

13
METHOD AND APPARATUS FOR DESORPTION AND IONIZATION OF ANALYTES
US
09/742,494

6,528,320

14
METHOD AND APPARATUS FOR DESCRIPTION AND IONIZATION OF ANALYTES
EP
94919287,6

15
RETENTATE CHROMATOGRAPHY AND PROTEIN CHIP ARRAYS WITH APPLICATIONS IN BIOLOGY AND MEDICINE
AU
83753/98

16
RETENTATE CHROMATOGRAPHY AND PROTEIN CHIP ARRAYS WITH APPLICATIONS IN BIOLOGY AND MEDICINE
NZ
501836

17
RETENTATE CHROMATOGRAPHY AND PROTEIN CHIP ARRAYS WITH APPLICATIONS IN BIOLOGY AND MEDICINE
US
09/100,708

Field of Use

Field of Use shall mean use of the Subject Technology for doing analyte detection, including all analytical measurements or assays other than bioanalytical or biological measurements or assays.

ProteinChip technology is based on SELDI, which combines laser-based molecular weight detection with the use of a chemically or biochemically active chip array surface constructed from proprietary-treated metal.

License Grant

Instrument Production Licensor grants French Licensee a nonexclusive, worldwide right and license, under Collaboration Licensor Intellectual Property and Background Licensor Intellectual Property, to make, and have made, import, offer to sell, sell, and use Instruments (including the HTS) solely in the NASBA Field of Use.

Cartridge Production Licensor grants Licensee a nonexclusive, worldwide right and license, under Collaboration Licensor Intellectual Property and Background Licensor Intellectual Property, to make, and have made, import, offer to sell, sell, and use Cartridges solely in the NASBA Field of Use.

Instrument Distribution Licensor appoints Licensee as its exclusive, worldwide distributor of Instruments (including the HTS) solely in the NASBA Field of Use.  Licensee may appoint sub-distributors to distribute the Instruments on its behalf.

Cartridge Distribution  Licensor appoints Licensee as its exclusive, worldwide distributor of Cartridges solely in the NASBA Field of Use.  Licensee may appoint sub-distributors to distribute the Cartridges on its behalf.

Development License  Licensee grants Licensor a nonexclusive, fully paid-up, worldwide right and license to (i) practice NASBA methods for research use only; and (ii) practice the Background Licensee Intellectual Property and Collaboration Licensee Intellectual Property, to develop Instruments, Cartridges, Software, Tests, and the High Throughput System in accordance with the Work Plan.

Manufacturing License  Licensee grants Licensor a nonexclusive, fully paid-up, worldwide right and license to manufacture for Licensee Instruments, HTS and Cartridges under all Licensee Intellectual Property Rights.

Collaboration Licensee Intellectual Property  Licensee grants Licensor an option to acquire a nonexclusive, royalty bearing, worldwide right and license to the Collaboration Licensee Intellectual Property to make, have made, import, offer to sell, sell, and use Instruments, Cartridges, Software, Tests and the High Throughput System solely in the Non-NASBA Field of Use upon terms and conditions to be agreed upon.

Collaboration Licensor and Collaboration Joint Intellectual Property  Licensee grants Licensor an exclusive, fully paid-up, worldwide right and license to make, have made, import, offer to sell, sell, and use the Collaboration Licensor and Collaboration Joint Intellectual Property solely in the Non-NASBA Field of Use.

License Property

Products means Instruments and Cartridges (including Licensor Instruments that have not been modified for use in the NASBA Field of Use, and pre-HTS Instruments), spare parts for such Instruments (“Spare Parts”) and Ancillary Disposables sold or transferred by a Party to the other Party under this Agreement.

Software means the Licensor software and firmware that is used to operate an Instrument to perform nucleic acid based analysis, and any necessary interfaces with the hardware and software of the end-user.

Instruments mean Licensors instruments, including Software, capable of carrying out a nucleic acid based analysis in the NASBA or Non-NASBA Fields of Use, in or with the use of a Cartridge or reaction tube, including Licensor’s GeneXpert and SmartCycler products, and the HTS, or any modified or improved version thereof.

Cartridge means a closed or substantially closed device, which may include a cartridge or reaction tube for performing Tests that contains, among other things, pelletized, dried or other type of reagents intended for single or multiple use sample preparation and nucleic acid analysis (including use in either the NASBA or Non-NASBA Fields of Use) and that is intended and suitable for insertion into, or use as a part of, or is a part or component of, or an attachment to, an instrument designed to hold such device and/or facilitate or enable its use, which instrument Licensor manufactures or has manufactured, including Licensor’s currently existing Instruments, or that can be used alone or with other instruments or devices, including the HTS, for such purpose.  For purposes of clarification, other ancillary disposables purchased by Licensee from Licensor for use with the Cartridges in performing a Test, but not contained in the Cartridge, such as buffer solutions, reagents, cuvettes, wash solutions, and so on (“Ancillary Disposables”), shall not be deemed to be included in the definition of Cartridge.

NASBA means Licensee’s proprietary isothermal, transcription-based nucleic acid amplification process, , involving the use of reverse transcriptase (“RT”), RNase H and RNA polymerase, substantially as described in U.S. Patent Nos. 5,130,238; 5,409,818; 5,654,142 and 6,312,298; EP Patents No. 0 368 906; 0 623 683 and 0373 960 and
foreign counterparts.
5,130,238 – Enhanced nucleic acid amplification process
5,409,818 – Nucleic acid amplification process
5,654,142 – Method for nucleic acid amplification using inosine triphosphates to partially replace guanosine triphosphates in the synthesis of multiple RNA copies
6,312,298 – Electromotive drive system for a ship

Patents mean (i) all patents and patent applications, (ii) any substitutions, divisions, continuations, continuations-in-part, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates and the like, and any provisional applications, of any such patents or patent application, and (iii) any foreign or international equivalent of any of the foregoing.

Collaboration Licensor Intellectual Property means all Intellectual Property Rights arising out of work performed under or in furtherance of this Agreement during the term of this Agreement that are invented (as determined by applicable US law with respect to patentable inventions), or otherwise conceived solely by one or more employees or agents of Licensor or its Affiliates, or solely by one or more employees or agents of Licensor or its Affiliates and one or more employees or agents of a Third Party.

Background Licensor Intellectual Property means all Intellectual Property Rights that are owned by, either partially or wholly, Licensor, or are licensed to, or otherwise controlled by, Licensor, excluding only Collaboration Licensor Intellectual Property and Collaboration Joint Intellectual Property.

Background Licensee Intellectual Property means all Intellectual Property Rights that are owned by, either partially or wholly, Licensee, or are licensed to, or otherwise controlled by, Licensee, excluding only Collaboration Licensee Intellectual Property, and Collaboration Joint Intellectual Property.

Collaboration Licensee Intellectual Property means all Intellectual Property Rights arising out of work performed under this Agreement or in furtherance of this Agreement during the term of this Agreement that are invented (as determined by applicable US law with respect to patentable inventions), or otherwise conceived solely by one or more employees or agents of Licensee or its Affiliates, or solely by one or more employees or agents of Licensee or its Affiliates and one or more employees or agents of a Third Party.

Field of Use

NASBA Field of Use means the preparation, purification, detection, quantification, amplification or analysis of nucleic acids in connection with the use of NASBA or TMA (trans-mediated amplification method).

The strategic commercial agreement relates to developing DNA testing products using Licensor's proprietary Nucleic Acid Sequence-Based Amplification technology to be run on systems employing our GeneXpert and SmartCycler systems.

License Grant

The Swiss Licensor grants a non-exclusive license under the Licensed Patents as follows
– to make, have made, import, use, offer to Sell and Sell Licensed Products in the In Vitro Human Diagnostics Field in the Territory, and authorize End-Users to perform Diagnostic Services using such Licensed Products in processes covered by the Licensed Patents in accordance with the label license provided with the purchase of such Licensed Products.
– to grant a limited, non-transferable, royalty free sublicense under the Licensed Patents to Research Collaborators of Licensee and/or its Affiliates to practice PCR under their respective contracts with Licensee and/or its Affiliates, in accordance with the terms and conditions of this Agreement, solely for purposes of doing applied research and development for Licensee and/or its Affiliates of Licensed Products to be Sold in the In Vitro Human Diagnostics Field in accordance with the other terms and conditions of this Agreement; and
– to use PCR technology for the research, development, improvement and quality control and quality assurance of Licensed Products, in each case by Licensee and its Affiliates, internally, for Sale in the In Vitro Human Diagnostics Field.

For Label Licenses on Licensed Products Sold in the In Vitro Human Diagnostics
– Licensees right to sublicense is limited to the right to convey use rights pursuant to a Label License under process claims and composition of matter claims,not apparatus, device or system claims, only to End-User customers, and only through the Sale of Licensed Products.
– Licensee agrees that it shall mark conspicuously all Complete Diagnostic Kits made by or for it,
– Licensee agrees that it shall mark conspicuously all Component Systems for amplification made by or for it
– Licensee agrees that it shall mark conspicuously all Component Systems for detection made by or for it
– Licensee agrees that it shall mark conspicuously all Component Systems for amplification and detection made by or for it
– Licensee agrees that it shall mark conspicuously all Royalty Products other than Complete Diagnostic Kits, Component Systems for amplification, Component Systems for detection and Component Systems for amplification and detection made by or for it and Sold in the In Vitro Human Diagnostics Field.

License Property

The Complete Diagnostic Kit means a product dedicated for use in connection with the practice of PCR in the In Vitro Human Diagnostics Field, it being understood that a product shall be deemed to be so dedicated if it is either  a product having a package insert indicating its use primarily in connection with the practice of PCR; or a product which by virtue of its design, operation or construction has no other substantial practical utility, and which product is comprised of, at a minimum, the essential active reagents for amplification and detection of a target nucleic acid in the In Vitro Human Diagnostics Field. For purposes of this Agreement, Licensee shall only convey the necessary rights for End-Users to perform PCR in the In Vitro Human Diagnostics Field with the Sale of a Complete Diagnostic Kit.

Licensed Product means a product for use in the In Vitro Human Diagnostics Field, the manufacture, importation, use, offer for Sale or Sale of which would infringe a Valid Claim of Licensed Patents, made by or specifically for Licensee or any of its Affiliates only pursuant to Licensees or its Affiliates specifications, which is any of the following or a combination of any of the following
(a) Complete Diagnostic Kit;
(b) A reagent, accessory, device or system which is used or Sold to be used by End-Users in connection with the practice of PCR, including the steps of sample preparation, amplification and detection;
(c) A Component System; and/or
(d) Reagents Sold to be used by End-Users as replacement components in regard to a Component System.

PCR means the polymerase chain reaction process and technology.

Patents relate to Process for Amplifying, Detecting, and/or Cloning Nucleic Acid Sequences.

Field of Use

This agreement is for the purpose of developing and commercializing PCR based in vitro human diagnostic products for use in clinical diagnostic testing;

The Human Identity Field means the field of use comprising products and processes utilizing PCR for the sole purpose of determining human identity or distinguishing among human beings, whether living or dead. The Term Human Identity Field shall included parentage testing to determine if two or more human beings are biologically related as parent and child and forensic testing for use in, or in preparation for, death investigations or other legal proceedings, but such term shall specifically exclude testing for tissue typing.

In Vitro Human Diagnostics Field means the field of use comprising products and processes utilizing PCR for the measurement, observation or determination of attributes, characteristics, diseases, traits or other conditions of a human being for the medical management of that human being, including without limitation
(a) genetic testing, including determinations of genetic predisposition;
(b) oncology and cancer predisposition testing;
(c) testing for tissue typing (excluding the Human Identity Field);
(d) infectious disease detection, screening, confirmation and monitoring; and
(e) therapeutic drug monitoring.

For purposes of this Agreement, the term 'In Vitro Human Diagnostics Field' shall not include the Human Identity Field.

“PCR” means the polymerase chain reaction process and technology involving the amplification of a nucleic acid sequence and the complement of that sequence by repeated cycles of oligonucleotide mediated, template directed synthesis involving the extension of a component primer oligonucleotide by incorporation of monomeric nucleotide triphosphates whereby the sequence, its complement and subsequent synthetic copies thereof are repeatedly separated and used as templates for further cycles of synthesis.